WO2022148308A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2022148308A1
WO2022148308A1 PCT/CN2021/143520 CN2021143520W WO2022148308A1 WO 2022148308 A1 WO2022148308 A1 WO 2022148308A1 CN 2021143520 W CN2021143520 W CN 2021143520W WO 2022148308 A1 WO2022148308 A1 WO 2022148308A1
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WO
WIPO (PCT)
Prior art keywords
stent
graft
layer coating
film
blood supply
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PCT/CN2021/143520
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English (en)
French (fr)
Inventor
朱永锋
徐健伟
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Publication of WO2022148308A1 publication Critical patent/WO2022148308A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • 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 present application relates to the technical field of medical devices, and in particular, to a covered stent.
  • Endovascular interventional therapy as a minimally invasive treatment, improves the survival probability for patients with vascular disease who cannot afford surgery.
  • Stent grafts as one of the important implants for endovascular interventional therapy, are widely used for endovascular aneurysm repair in patients with abdominal aneurysms.
  • implanted stent-grafts after repair may develop type II endoleaks, causing further tumor enlargement and life-threatening consequences for the patient.
  • the mainstream treatment method for abdominal aortic type II endoleak is secondary intervention, that is, another operation is required, which puts the patient at greater risk.
  • a novel stent-graft includes a metal stent and an inner-layer membrane, and the inner-layer membrane can be disposed on the metal stent and formed along the The axially through lumen of the metal stent, wherein the covered stent further comprises an outer layer covering, and the outer layer covering is arranged on the outside of the inner layer covering and can be covered relative to the inner layer.
  • the membrane is changed from a first state to a second state to form a sandwich cavity between the outer coating and the inner coating.
  • At least one sandwich cavity may be formed between the outer-layer coating and the inner-layer coating, wherein the outer-layer coating may include one or more outer-layer coating membrane.
  • the inner layer coating may have a preset leakage amount, and the preset leakage amount is in the range of 300 ml/cm 2 /min to 1000 ml/cm 2 /min.
  • a prothrombotic agent or villi may be placed in the clip cavity.
  • the stent-graft may further include a filler disposed in the clip cavity, the filler may be used to support the outer graft to the second state.
  • the outer layer film can surround the blocking part of the inner layer film, and the proximal end and the distal end of the outer layer film can be sealed and fixed to the inner layer, respectively.
  • the material of the inner layer coating and/or the outer layer coating may include at least one of PET, ePTFE or Tpu.
  • the proximal end and the distal end of the outer layer coating can be fixed to the outer side of the inner layer coating by sewing and/or heat fusion.
  • At least one visceral artery blood supply site may be provided on the inner film; the number of the clip cavities may be greater than or equal to 2, and the clip cavities may extend along the inner The direction from the proximal end to the distal end of the layer covering is distributed in sequence, and the two adjacent clip cavities are located at the distal and proximal sides of the corresponding visceral artery blood supply positions.
  • the number of the outer layer coating may be greater than or equal to 2, and the sandwich cavity is formed between each of the outer layer coating and the inner layer coating.
  • At least one visceral artery blood supply site may be provided on the inner layer covering, the number of the outer covering and the clip cavity is one, and the outer covering
  • the membrane has at least one blood supply window, and the part of the outer membrane around the blood supply window is fixed on the inner membrane, and the blood supply window communicates with the corresponding blood supply position of the visceral artery.
  • At least one visceral artery blood supply site may be disposed on the inner layer membrane, the number of the outer layer membrane may be one, and the number of the clip cavities may be Two or more, wherein, at least one of the at least one visceral arterial blood supply site may be between two adjacent clip cavities, wherein the outer membrane may have at least one A blood supply window, the part around the blood supply window in the outer covering film can be fixed on the inner covering film, and the blood supply window can communicate with the corresponding blood supply position of the visceral artery.
  • the stent-graft may include a main stent-graft and a branch stent-graft connected to a distal end of the main stent-graft.
  • the distal end of the outer coating can be fixed on the inner coating of the branch stent-graft or the main stent-graft.
  • the proximal end of the outer coating can be fixed on the inner coating of the branch stent-graft or the main stent-graft.
  • the stent-graft as described above can be used in the field of treatment of abdominal aortic aneurysms.
  • the lumen of the inner-layer covering can make the normal flow of abdominal aortic blood flow, and is surrounded by the outer layer outside the inner-layer covering.
  • the membrane can be stretched to form a close surface of the aneurysm wall or the close surface of the arterial vessel wall, which can block the branch blood vessels on the abdominal aortic aneurysm and block the blood flow in the branch blood vessels to prevent type II Endoleak, and avoid further enlargement of abdominal aortic aneurysm body without secondary intervention, that is, without the need for another surgery, thus avoiding greater risk to the patient.
  • FIG. 1 is a schematic structural diagram of a stent graft according to a first embodiment of the present application
  • FIG. 2 is a schematic diagram of the installation of the stent graft according to the first embodiment of the present application
  • FIG. 3 is a schematic view of the installation of the stent graft according to the second embodiment of the present application.
  • FIG. 4 is a schematic diagram of the installation of the stent graft according to the third embodiment of the present application.
  • FIG. 5 is a schematic diagram of the installation of the stent graft according to the fourth embodiment of the present application.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature delimited with “first”, “second” may expressly or implicitly include at least one of that feature.
  • plurality means at least two, such as two, three, etc., unless expressly and specifically defined otherwise.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • installed may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • a first feature "on” or “under” a second feature may be in direct contact with the first and second features, or the first and second features indirectly through an intermediary touch.
  • the first feature being “above”, “over” and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature being “below”, “below” and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
  • FIG. 1 shows a schematic structural diagram of the stent graft according to the first embodiment of the present application.
  • the stent-graft includes a metal stent 100 , an inner-layer membrane 200 and at least one outer-layer membrane 300 .
  • the inner layer coating 200 is attached to the metal stent 100 and forms a through lumen along the axial direction of the metal stent 100 .
  • the outer layer coating 300 surrounds the outer side of the inner layer coating 200 and forms a cavity or sandwich cavity A therebetween. Each outer layer coating 300 forms a cavity with the inner layer coating 200 , so that at least one sandwich cavity A is formed between at least one outer layer coating 300 and the inner layer coating 200 .
  • both ends (ie, the proximal end and the distal end) of each outer-layer coating 300 are bonded to the inner-layer coating 200, and the portion between the two ends of the outer-layer coating 300 and the inner-layer coating 200 are capable of separated so that the outer film 300 can be stretched or propped up if filler is present, thereby forming the cavity or sandwich cavity A described above between the outer film 300 and the inner film 200 .
  • the inner diameter of the outer layer coating 300 is larger than the outer diameter of the inner layer coating 200 when the outer layer coating film 300 is stretched or stretched.
  • the stent grafts involved in the embodiments of the present application can be applied to the field of treatment of abdominal aortic aneurysms, and the outer membrane 300 can be stretched to block the branch blood vessels 400 on the aortic aneurysm.
  • the branch blood vessels 400 do not refer to important visceral arteries such as the bilateral renal arteries, the celiac trunk, the superior mesenteric artery, etc., but refer to the branches that do not cause serious complications to the human body even if they do not pass blood Blood vessel.
  • the lumen of the inner covering 200 is used to allow the normal flow of blood flow in the abdominal aorta.
  • the material of the metal stent 100 is a metal material with biocompatibility, such as nickel-titanium alloy, stainless steel, and the like.
  • the metal bracket 100 includes a plurality of support rings arranged at intervals; the support rings may have structures such as a circular ring type, a wave type, and the like.
  • the proximal end of the metal stent 100 is provided with a bare metal stent 110 , and the bare metal stent 110 is used for anchoring the covered stent.
  • the bare metal stent 110 may have a ring shape, a wave shape or the like.
  • the stent-graft as described above can be applied in the field of treatment of abdominal aortic aneurysms, wherein the lumen of the inner-layer covering 200 can make the normal flow of abdominal aortic blood flow, and is surrounded on the outside of the inner-layer covering 200
  • the outer membrane 300 can be stretched to form a tumor cavity wall-adhering surface or an arterial vessel wall-adhering surface, so that the branch blood vessels 400 on the abdominal aortic aneurysm can be blocked.
  • the stent-graft with the outer layer covering 300 it is possible to block the blood flow backflow in the branch blood vessel 400, prevent type II endoleak, and avoid further enlargement of the abdominal aortic aneurysm without the need for two secondary intervention (ie, without the need for another surgery), thereby avoiding greater risk to the patient.
  • a tumor cavity wall-adhering surface F1 can be formed.
  • the abutment surface F1 of the aneurysm wall closely adheres to the inner wall of the aneurysm cavity of the abdominal aortic aneurysm, which can cover the branch blood vessel 400 and block the branch blood vessel.
  • the blood flow in 400 can also make the outer covering 300 closely contact with the proximal and distal ends of the abdominal aortic aneurysm, so that the proximal and distal ends of the stent-graft can be fitted to the abdominal aorta vessels.
  • the type I endoleak caused by not being tight plays a certain blocking role.
  • the proximal end refers to the end close to the heart
  • the distal end refers to the end away from the heart.
  • the inner layer coating 200 has a preset leakage amount, so that the blood flow in the lumen formed by the inner layer coating 200 can pass through the inner layer coating 200 It flows into the cavity A between the outer layer film 300 and the inner layer film 200 , and further stretches the outer layer film 300 . More specifically, due to the leakage of the inner layer covering 200 in a short period of time after the operation, the blood flow in the lumen formed by the inner covering film 200 can slowly enter into the outer covering film 300 and the outer covering film 300 through the inner covering film 200. In the sandwich cavity A between the inner coverings 200 , the outer coverings 300 are further stretched to achieve the purpose of blocking the branch blood vessels 400 .
  • the preset leakage amount is 300ml/cm 2 /min to 1000ml/cm 2 /min, for example, it can be set to 300ml/cm 2 /min, 400ml/cm 2 /min, 500ml/cm 2 /min, 600ml /cm 2 /min, 700ml/cm 2 /min, 800ml/cm 2 /min, 900ml/cm 2 /min, 1000ml/cm 2 /min, etc.
  • Setting the range of the preset leakage amount in this way can ensure that the blood flow in the lumen formed by the inner layer covering film 200 smoothly enters into the sandwich cavity A between the inner layer covering film 200 and the outer layer covering film 300, so that the Opening the outer covering film 300 in time to block the branch blood vessels 400 can also ensure that the blood flow in the lumen formed by the inner covering film 200 can slowly flow into the clamping cavity A, so as to ensure the long-term thrombus formation in the clamping cavity A.
  • type II endoleaks are continuously prevented from occurring.
  • the inner layer coating 200 can be an ePTFE (Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene) coating, a PET (Polyethylene terephthalate, polyester resin) single/multifilament membrane or other leakage amounts ranging from 300ml/cm 2 /min to Films in the range of 1000ml/ cm2 /min.
  • ePTFE Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene
  • PET Polyethylene terephthalate, polyester resin
  • a prothrombotic agent or villi may be placed in the sandwich cavity A between the outer membrane 300 and the inner membrane 200 .
  • the thrombosis-promoting agent may be a chemical agent, and the chemical agent may contain natural polysaccharide gum, Apelin-17 and other components that promote thrombosis.
  • the stent-graft further includes: a filler placed in the clip cavity A, the filler is used to stretch the outer covering film 300 .
  • the method of filling filler in the stent-graft is as follows: firstly, the stent-graft is implanted into the abdominal aortic aneurysm; then the outer layer 300 and the inner layer 200 are filled through the filling window on the outer layer Filling is injected into the sandwich cavity A between, to stretch the outer layer film 300; finally, the filling window on the outer layer film 300 is blocked.
  • the filler is silica gel.
  • Silica gel has the characteristics of elasticity and deformability, so that the outer covering 300 can fill tumors of different shapes or structures, ensuring that the outer covering 300 can effectively block the blood flow backflow in the branch blood vessels 400, and can also prevent the stent covered by the covering.
  • the type I endoleak caused by the incompatibility between the proximal and distal ends of the vasculature plays an effective role in alleviating the type I endoleak.
  • the present application is not limited to this, and in some embodiments of the present application, the filler can also use other filler materials that can be used for intervention.
  • the outer layer coating 300 surrounds the blocking portion of the inner layer coating 200 .
  • the proximal end and the distal end of the outer layer membrane 300 are sealed and fixed at the proximal end and the distal end of the blocking part, respectively.
  • the outer layer membrane 300 includes a flexible material, the surface area of the outer layer membrane 300 is greater than the surface area of the barrier, and the surface area of the outer layer membrane 300 is equal to or greater than the surface area of the inner wall of the abdominal aortic aneurysm, so that the outer layer membrane 300 can fully adhere to the inner wall of the tumor cavity.
  • the blocking part of the inner layer coating 200 refers to the part of the inner layer coating 200 used to separate the inner cavity of the inner layer coating 200 from the sandwich cavity A, that is, the inner layer coating 200 and the sandwich cavity A are separated.
  • the corresponding part of the outer layer coating 300 in the axial direction of the metal stent 100 may include not only the circumferential surface of the proximal end and the distal end of the inner layer coating 200, but also the inner layer coating 200 except the proximal end and the distal end. Circumferential surfaces other than at the ends.
  • the blocking portion of the inner-layer coating 200 is used to block the cavity of the inner-layer coating 200 from the sandwich cavity A between the inner-layer coating 200 and the outer-layer coating 300 .
  • the outer layer coating 300 may or may not be formed of an elastic material. That is, it is not necessary to stretch and expand the outer layer coating 300, which can not only ensure that the blood flow can stretch the outer layer coating 300 through its own tiny pressure, so there is no need to change the material of the outer layer coating 300. Resilience issues impose specific constraints.
  • the outer layer coating 300 is made of a flexible material, such as a polymer soft material with good biocompatibility, the outer layer coating 300 can be deformed under the action of force, so when it is not stretched In a first state (also referred to as a collapsed state, a folded state, a drooping state, or a relaxed state), the outer film 300 can stand up and change from the first state to the second state when supported by an external force, that is, be It is propped up (ie, in a filled state or an unfolded state), thereby forming a sandwich cavity A between the outer film 300 and the inner film 200 .
  • the outer cover 300 is bonded to the inner cover 200 like a pocket.
  • the material of the inner layer coating 200 and/or the outer layer coating 300 is at least one of PET, ePTFE or Tpu (Thermoplastic polyurethanes, thermoplastic polyurethane elastomer rubber).
  • the outer layer coating 300 formed by at least one of the above-mentioned materials also has a certain amount of leakage, for example, about 300ml/cm 2 /min to 1000ml/cm 2 /min, but by The flow rate and flow velocity of the inner layer covering 200 penetrating into the clip cavity A between the inner covering film 200 and the outer covering film 300 are too small, so that this part of the fluid basically does not flow from the outer covering film 300 to the abdominal aortic aneurysm. Leakage in the tumor cavity of the body. Even if there is leakage, the amount of leakage is very small and will not affect the human body and can be ignored.
  • the cavity A formed between the outer film 300 and the inner film 200 is a closed space, that is, except for the necessary leakage due to the preset leakage, the cavity A is formed.
  • no holes are formed on the outer layer coating 300 .
  • the inner layer coating 200 is fixed to the metal bracket 100 by sewing or heat fusion.
  • the proximal end and the distal end of the outer layer coating 300 are respectively fixed to the outer side of the inner layer coating 200 by means of sewing and/or heat fusion.
  • the inner layer coating 200 is integrally connected to the metal stent 100 , that is, it is provided on the metal stent 100 in a covering manner.
  • the inner layer coating 200 is located on the inner side or the outer side of the metal stent 100
  • the outer layer coating 300 is located on the outer side of the metal stent 100 .
  • At least one visceral artery blood supply site is provided on the inner layer membrane 200 ; the number of clip cavities A can be greater than or equal to 2; clip cavities A are sequentially distributed along the direction from the proximal end to the distal end of the inner layer membrane 200, and two adjacent clip cavities A are supplied by one or more visceral arteries Separated and located distally and proximally of the splanchnic artery blood supply site, respectively.
  • the splanchnic artery blood supply position is used to supply blood to the splanchnic arteries 600 such as the bilateral renal arteries, the celiac trunk, and the superior mesenteric artery.
  • the stent-graft can ensure the normal blood supply of the splanchnic artery 600 on the premise of blocking the blood flow backflow in the branch blood vessel 400, thereby avoiding serious complications.
  • a blood flow window is opened at the blood supply site of the visceral artery of the inner film 200 .
  • the inner layer coating 200 may be further provided with embedded branches embedded at the blood passage windows. The embedded branches can be used to install branch vascular stents or directly formed into branch vascular stents, which are used to supply blood to visceral arteries.
  • the number of the outer layer coating 300 may be greater than or equal to 2, and a cavity A is formed between each outer layer coating 300 and the inner layer coating 200 .
  • the number of the outer layer coating 300 is the same as the number of the cavity A, that is, one outer coating film 300 corresponds to one cavity A.
  • At least one visceral artery blood supply site may be provided on the inner membrane 200 , and the number of the outer membrane 300 and the clip cavity A may be one.
  • at least one blood supply window is correspondingly provided on the outer layer membrane 300, and the part of the outer layer membrane 300 around the blood supply window can be fixed on the inner layer membrane 200, and the blood supply window and the corresponding visceral artery can be fixed on the inner layer membrane 200. The blood supply is connected.
  • the parts of the outer layer covering film 300 around the blood supply window are fixed on the inner layer covering film 200 by means of heat fusion and/or sewing.
  • two or more sandwich cavities A may also be formed by using one outer layer film 300 , wherein the outer layer film 300 forms a ring shape between two adjacent sandwich cavities A. Parts are fixed on the inner layer coating 200 by means of heat fusion and/or sewing. Similar to the above embodiments, blood supply windows can be selectively provided in the annular portion to communicate with the corresponding visceral artery blood supply positions on the inner covering 200 . Accordingly, the portion of the outer layer coating 300 around the provided blood supply window is fixed on the inner layer coating 200 . In addition, at least one of the two or more clip lumens described above may cover the corresponding branch blood vessel when filled or deployed.
  • the stent-graft includes a main stent-graft and a branched stent-graft connected with the distal end of the main stent-graft.
  • the distal end of the outer covering 300 can be fixed on the inner covering 200 of the branched stent-graft.
  • the branched stent-graft is used to supply blood to the iliac artery. In this way, abdominal aortic aneurysms located at different positions in the abdomen can be treated to expand the application range of the stent-graft.
  • the main stent-graft refers to the undivided part of the stent-graft
  • the branched stent-graft refers to the bifurcated part of the stent-graft.
  • the distal end of the outer layer covering 300 is fixed to the proximal end of the inner layer covering 200 of the branched stent-graft, or to the middle of the inner covering 200 of the branched stent-graft, or to the branch covering
  • the inner layer of the stent covers the distal end of 200 .
  • the middle part of the inner layer covering 200 of the branched stent-graft refers to the part between the proximal end and the distal end of the inner covering 200 of the branched stent-graft.
  • the outer covering film 300 when the outer covering film 300 is stretched, at least a part thereof can form an arterial vessel wall abutting surface F2 (see FIGS. 3 to 5 ).
  • the arterial vessel wall abutting surface F2 can be in close contact with the inner wall of the iliac artery 500, thereby preventing the I. type endoleak.
  • the number and distribution positions of the outer layer covering 300 are related to the positional relationship between the proximal end of the branched stent-graft, the branch blood vessel 400 and the visceral artery 600, which will be described in detail below with reference to FIGS. 2 to 5:
  • the number of the outer coverings 300 is one and close to one another.
  • the end surrounds the outer side of the inner layer coating 200 of the main stent-graft and the distal end surrounds the proximal end of the branch stent-graft, and covers the branch blood vessel 400 at the same time.
  • the blood flow from top to bottom in FIG. 2 can slowly enter through the inner layer coating 200 to the In the clip cavity A between the inner membrane 200 and the outer membrane 300, the outer membrane 300 is expanded until it fills the entire aneurysm cavity of the abdominal aortic aneurysm.
  • This can cover the branch blood vessels 400 on the abdominal aortic aneurysm, thereby blocking the blood flow in the branch blood vessels 400 and preventing type II endoleak, and at the same time, it can also prevent the proximal and distal ends of the stent-graft and the aorta.
  • the type I endoleak caused by the loose fitting of blood vessels plays a certain blocking role. Not only that, the slow flow of blood flow can cause thrombus to form in the sandwich cavity A between the inner membrane 200 and the outer membrane 300, and continuously prevent the occurrence of type II endoleak.
  • the number of the outer coverings 300 can be only one
  • the proximal end of the stent-graft is surrounded by the outer side of the inner layer 200 of the main stent-graft, and the distal end of the stent-graft is surrounded by the proximal end of the branch stent-graft and the iliac artery bifurcation point 500a.
  • the outer layer membrane 300 shown in FIG. 3 is stretched, when the horizontal dotted line shown in FIG. 3 is used as the boundary line, the outer surface located above the boundary line constitutes the tightness of the tumor cavity wall.
  • the veneer F1, the outer surface below the boundary constitutes the arterial vessel wall apposition F2.
  • the outer membrane 300 expands to fill the entire aneurysm cavity of the abdominal aortic aneurysm and covers the branch blood vessels 400, and gradually A thrombus is generated in the sandwich cavity A formed between the inner membrane 200 and the outer membrane 300, thereby preventing type II endoleaks in the short and long term; Endoleak also plays a certain blocking role.
  • the number of the outer layers 300 may be two, that is, the outer layers 300 include the proximal outer layer 310 and the distal outer layer 320 .
  • the proximal outer layer membrane 310 is arranged around the part of the main stent-graft above the visceral artery 600 to cover the corresponding branch blood vessel 400 .
  • the proximal end of the distal outer layer covering 320 is enclosed at the position between the proximal end of the branched stent-graft and the visceral artery 600, and the distal end thereof is enclosed between the proximal end of the branched stent-graft and the iliac artery bifurcation point 500a. part in between.
  • proximal outer layer membrane 310 shown in FIG. 4 is stretched (also referred to as unfolding)
  • its outer surface constitutes the tumor cavity wall abutting surface F1.
  • the distal outer layer membrane 320 shown in FIG. 4 is stretched, when the dotted line shown in FIG. 4 is used as the boundary, the outer surface located above the boundary constitutes the tumor cavity wall abutting surface F1 , the outer surface below the boundary constitutes the arterial vessel wall abutment surface F2.
  • This type of stent-graft can prevent type II endoleaks.
  • the stent-graft of this type of structure can also be used. Prevention of type I endoleaks.
  • the number of outer layers 300 may be two, that is, the outer layers 300 include a proximal outer layer 310 and a distal outer layer 320 .
  • the proximal outer membrane 310 is surrounded by the portion between the proximal end of the branch stent-graft and the visceral artery 600, and the distal outer membrane 320 is surrounded by the branch stent at the point between the visceral artery 600 and the iliac artery.
  • the area between the fork points 500a It should be noted that, when the proximal outer layer membrane 310 shown in FIG. 5 is stretched, the outer surface of itself constitutes the arterial vessel wall abutting surface F2.
  • the stent-graft of this type of structure shown in FIG. 5 can not only prevent type II endoleak; at the same time, with the gradual expansion of the distal outer covering 320 and sticking to the inner wall of the iliac artery, the stent-graft can prevent distal leakage of the stent-graft.
  • Type I endoleak caused by the loose fitting of the end to the blood vessel.

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Abstract

一种覆膜支架。该覆膜支架包括金属支架（100）和内层覆膜（200），内层覆膜（200）被设置于金属支架（100）上并形成沿金属支架（100）的轴向贯通的内腔，覆膜支架还包括外层覆膜（300），其中，外层覆膜（300）围设于内层覆膜（200）的外侧并能够相对于内层覆膜（200）从第一状态变化到第二状态，以在外层覆膜（300）与内层覆膜（200）之间形成夹腔（A）。该覆膜支架可应用于腹主动脉瘤体的治疗领域中，内层覆膜（200）的内腔能够使腹主动脉血流的正常流动，围设于内层覆膜（200）外侧的外层覆膜（300）能够撑开以形成瘤腔壁紧贴面（F1）或动脉血管壁紧贴面（F2），可封堵腹主动脉瘤体上的分支血管（400），阻挡分支血管（400）内的血流返流，预防Ⅱ型内漏，避免腹主动脉瘤体进一步扩大，无需二次干预，即不需要再进行一次手术，从而避免患者承受更大的风险。

Description

覆膜支架
相关申请的交叉引用
本申请要求于2021年1月5日提交到中国专利局、申请号为202110006848.5且发明名称为“覆膜支架”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及医用器械技术领域，特别是涉及一种覆膜支架。
背景技术
血管腔内介入治疗作为一种微创的治疗方式，为不能承受外科手术的血管疾病患者提升了生存概率。覆膜支架，作为血管腔内介入治疗的重要植入物之一，被广泛用于对腹动脉瘤患者进行血管腔内动脉瘤修复。然而，在修复之后被植入的覆膜支架可能会发生II型内漏，造成瘤体进一步扩大，给患者带来生命危险。而现阶段对于腹主动脉II型内漏的主流治疗方法是二次干预，即需要再进行一次手术，这使患者承受更大的风险。
发明内容
根据本申请的一方面，提供一种新型的覆膜支架，所述覆膜支架包括金属支架和内层覆膜，所述内层覆膜可被设置于所述金属支架上并形成沿所述金属支架的轴向贯通的内腔，其中，所述覆膜支架还包括外层覆膜，所述外层覆膜围设于所述内层覆膜的外侧并能够相对于所述内层覆膜从第一状态变化到第二状态，以在所述外层覆膜与所述内层覆膜之间形成夹腔。
在根据本申请的至少一个实施例中，所述外层覆膜与所述内层覆膜之间可形成至少一个夹腔，其中，所述外层覆膜可包括一个或多个外层覆膜。
在根据本申请的至少一个实施例中，所述内层覆膜可具有预设渗漏量，所述预设渗漏量在300ml/cm 2/min至1000ml/cm 2/min的范围内。
在根据本申请的至少一个实施例中，所述夹腔中可置有促血栓形成剂或绒毛。
在根据本申请的至少一个实施例中，所述覆膜支架还可包括置于所述夹腔中的填充物，所述填充物可用于支撑所述外层覆膜至所述第二状态。
在根据本申请的至少一个实施例中，所述外层覆膜可围绕所述内层覆膜的 阻隔部，并且所述外层覆膜的近端、远端可分别密封固定到所述内层覆膜，其中，所述外层覆膜由柔性材料制成。
在根据本申请的至少一个实施例中，所述内层覆膜和/或所述外层覆膜的材料可包括PET、ePTFE或Tpu中的至少一种。
在根据本申请的至少一个实施例中，所述外层覆膜的近端和远端可通过缝制和/或热熔的方式固定于所述内层覆膜的外侧。
在根据本申请的至少一个实施例中，所述内层覆膜上可设置有至少一个内脏动脉供血位；所述夹腔的数目可大于或等于2，所述夹腔可沿由所述内层覆膜的近端至远端的方向依次分布且相邻两个夹腔位于对应的内脏动脉供血位的远侧和近侧。
在根据本申请的至少一个实施例中，所述外层覆膜的数目可大于或等于2，每个所述外层覆膜与所述内层覆膜之间均形成有所述夹腔。
在根据本申请的至少一个实施例中，所述内层覆膜上可设置有至少一个内脏动脉供血位，所述外层覆膜与所述夹腔的数量均为1个，所述外层覆膜上具有至少一个供血窗口且所述外层覆膜中位于所述供血窗口周围的部位固定在所述内层覆膜上，所述供血窗口与对应的所述内脏动脉供血位相通。
在根据本申请的至少一个实施例中，所述内层覆膜上可设置有至少一个内脏动脉供血位，所述外层覆膜的数量可为1个，而所述夹腔的数量可为两个或更多个，其中，所述至少一个内脏动脉供血位中的至少一个内脏动脉供血位可在相邻的两个夹腔之间，其中，所述外层覆膜上可具有至少一个供血窗口，所述外层覆膜中位于所述供血窗口周围的部位可固定在所述内层覆膜上，并且所述供血窗口可与对应的所述内脏动脉供血位相通。
在根据本申请的至少一个实施例中，所述覆膜支架可包括主体覆膜支架和与所述主体覆膜支架的远端连接的分支覆膜支架。
在根据本申请的至少一个实施例中，所述外层覆膜的远端可固定于所述分支覆膜支架或所述主体覆膜支架的内层覆膜上。
在根据本申请的至少一个实施例中，所述外层覆膜的近端可固定于所述分支覆膜支架或所述主体覆膜支架的内层覆膜上。
如上所述的覆膜支架，可应用于腹主动脉瘤体的治疗领域中，内层覆膜的内腔能够使腹主动脉血流的正常流动，围设于内层覆膜外侧的外层覆膜能够被撑开以形成瘤腔壁紧贴面或动脉血管壁紧贴面，由此可封堵腹主动脉瘤体上的分支血管和阻挡分支血管内的血流返流，预防Ⅱ型内漏，并避免腹主动脉瘤体进一 步扩大，而无需二次干预，即不需要再进行一次手术，从而避免患者承受更大的风险。
附图说明
图1为根据本申请第一实施例的覆膜支架的结构示意图；
图2为根据本申请第一实施例的覆膜支架的安装示意图；
图3为根据本申请第二实施例的覆膜支架的安装示意图；
图4为根据本申请第三实施例的覆膜支架的安装示意图；
图5为根据本申请第四实施例的覆膜支架的安装示意图。
其中，附图中的标号说明如下：
100、金属支架；110、裸金属支架；200、内层覆膜；300、外层覆膜；310、近端外层覆膜；320、远端外层覆膜；A、夹腔；400、分支血管；500、髂动脉；500a、髂动脉分叉点；600、内脏动脉；F1、瘤腔壁紧贴面；F2、动脉血管壁紧贴面。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请内涵的情况下做类似改进，因此本申请不受下面公开的具体实施例的限制。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，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申请的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，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，除非另有明确的限定。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申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，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”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
图1示出了根据本申请第一实施例的覆膜支架的结构示意图。如图1所示，覆膜支架包括金属支架100、内层覆膜200以及至少一个外层覆膜300。内层覆膜200附于金属支架100上并沿着金属支架100的轴向形成贯通的内腔。外层覆膜300围设于内层覆膜200的外侧并在两者之间形成空腔或夹腔A。每个外层覆膜300均与内层覆膜200形成一个空腔，由此至少一个外层覆膜300与内层覆膜200之间形成至少一个夹腔A。例如，每个外层覆膜300的两端(即，近端和远端)被结合到内层覆膜200，外层覆膜300的两端之间的部分与内层覆膜200是能够分离的，从而如果存在填充物的情况下，外层覆膜300能够被撑开或撑起来，由此在外层覆膜300与内层覆膜200之间形成上述空腔或夹腔A。在外层覆膜300被撑开或被撑起来的状态下，外层覆膜300的内直径大于内层覆膜200的外直径。
需要说明的是，本申请的实施例所涉及的覆膜支架可应用于腹主动脉瘤体的治疗领域中，外层覆膜300能够被撑开从而封堵主动脉瘤体上的分支血管400(参见图2至图5)，分支血管400并非是指双肾动脉、腹腔干、肠系膜上动脉等重要的内脏动脉，而是指对于人体来说即使不通血也不会引发严重并发症的 分支血管。另外，内层覆膜200的内腔用于使腹主动脉中的血流正常流动。
作为示例性实施例，如图1至图5所示，金属支架100的材料为具有生物相容性的金属材料，例如镍钛合金、不锈钢等。其中，金属支架100包括间隔设置的多个支撑环；支撑环可以具有圆环型、波浪型等结构。可选地，如图1所示，金属支架100的近端上设置有裸金属支架110，裸金属支架110用于覆膜支架的锚定。其中，裸金属支架110可以具有圆环型、波浪型等结构。
如上所述的覆膜支架可应用于腹主动脉瘤体的治疗领域中，其中，内层覆膜200的内腔能够使腹主动脉血流的正常流动，围设于内层覆膜200外侧的外层覆膜300能够被撑开以形成瘤腔壁紧贴面或动脉血管壁紧贴面，从而可封堵腹主动脉瘤体上的分支血管400。通过使用根据本申请的实施例的具有外层覆膜300的覆膜支架，可以阻挡分支血管400内的血流返流、预防Ⅱ型内漏和避免腹主动脉瘤体进一步扩大，而无需二次干预(即，不需要再进行一次手术)，从而避免患者承受更大的风险。
在本申请的一些实施例中，如图2至图4所示，外层覆膜300在被撑开时能够形成瘤腔壁紧贴面F1。当外层覆膜300充满腹主动脉瘤体的瘤腔时，其瘤腔壁紧贴面F1与腹主动脉瘤体的瘤腔内壁紧密贴合，既可以覆盖分支血管400而阻断分支血管400内的血流返流，也可以使外层覆膜300与腹主动脉瘤体的近端和远端密切接触，由此能够对覆膜支架的近、远端与腹主动脉血管贴合不紧密所引起的I型内漏起到一定的阻挡作用。全文中的近端是指靠近心脏的一端，远端是指远离心脏的一端。
关于如何撑开外层覆膜300，本申请给出两种示例：
第(1)种，在本申请的一些实施例中，内层覆膜200具有预设渗漏量，以使内层覆膜200形成的内腔中的血流能够穿过内层覆膜200流入外层覆膜300与内层覆膜200之间的夹腔A中，进而撑开外层覆膜300。更为具体地，由于内层覆膜200术后短期内的渗漏，可以使得内层覆膜200形成的内腔中的血流穿过内层覆膜200缓慢进入至外层覆膜300与内层覆膜200之间的夹腔A中，进而撑开外层覆膜300，达到封堵分支血管400的目的。
可选地，预设渗漏量为300ml/cm 2/min至1000ml/cm 2/min，例如可以设置为300ml/cm 2/min、400ml/cm 2/min、500ml/cm 2/min、600ml/cm 2/min、700ml/cm 2/min、800ml/cm 2/min、900ml/cm 2/min、1000ml/cm 2/min等。如此设置预设渗漏量的范围，既可以保证内层覆膜200形成的内腔中的血流顺利地进入至内层覆膜200与外层覆膜300之间的夹腔A中，以便及时撑开外层覆膜300进而封堵分支血 管400，也可以保证内层覆膜200形成的内腔中的血流能够缓慢地流入至夹腔A中，保证夹腔A内远期形成血栓，从而持续地防止II型内漏发生。其中，内层覆膜200可以为ePTFE(Expanded Polytetrafluoroethylene，膨体聚四氟乙烯)覆膜、PET(Polyethylene terephthalate，涤纶树脂)单/复丝膜或其它渗漏量在300ml/cm 2/min至1000ml/cm 2/min范围内的覆膜。
可选地，外层覆膜300与内层覆膜200之间的夹腔A中可以置有促血栓形成剂或绒毛。其中，促血栓形成剂可以为化学药剂，该化学药剂中可以含有天然多糖胶、Apelin-17等促进血栓形成的成分。
第(2)种，在本申请的其他一些实施例中，覆膜支架还包括：置于夹腔A中的填充物，该填充物用于撑开外层覆膜300。在覆膜支架中填充填充物的方法如下：首先将覆膜支架植入至腹主动脉瘤体中；然后通过外层覆膜300上的填充窗口向外层覆膜300与内层覆膜200之间的夹腔A中注入填充物，以将外层覆膜300撑开；最后封堵外层覆膜300上的填充窗口。
可选地，填充物为硅胶。硅胶具有弹性可变形的特性，使得外层覆膜300可以填充不同形状或结构的瘤体，保证外层覆膜300可有效阻挡分支血管400中的血流返流，也可以对由覆膜支架的近、远端与血管贴合不紧密所引起的I型内漏起到有效的缓解作用。本申请不限于此，在本申请的一些实施例中，填充物也可以采用其他可用于介入的填充材料。
如图1至图5所示，在本申请的一些实施例中，外层覆膜300围绕内层覆膜200的阻隔部。外层覆膜300的近端和远端分别密封固定在阻隔部的近端和远端。外层覆膜300包括柔性材料，外层覆膜300的表面积大于阻隔部的表面积，而外层覆膜300的表面积等于或大于腹主动脉瘤体的瘤腔内壁的表面积，使得外层覆膜300能充分紧贴瘤腔内壁。
需要说明的是，内层覆膜200的阻隔部是指内层覆膜200中用于将内层覆膜200的内腔与夹腔A隔开的部位，即，内层覆膜200中与外层覆膜300在金属支架100轴向上相对应的部分，既可以包括内层覆膜200的近端、远端处的圆周面，也以包括内层覆膜200中除了近端、远端处之外的其他部位处的周面。内层覆膜200的阻隔部用于将内层覆膜200的腔体和内层覆膜200与外层覆膜300之间的夹腔A相阻隔。
外层覆膜300可以由弹性材料形成，也可以不由弹性材料形成。即，无需使外层覆膜300通过拉伸膨胀的方式进行撑开，这样不仅可以保证血流通过自身微小压力便可将外层覆膜300撑开，因此无需对外层覆膜300的材料的弹性问 题进行特定限制。可以理解的是，由于外层覆膜300采用柔性材料，例如生物相容性好的高分子软质材料，所以外层覆膜300可在力的作用下发生变形，故在未被撑开时处于第一状态(也可被称为塌陷状态、折叠状态、耷拉状态或松弛状态)，在受到外力支撑时外层覆膜300可挺立起来而从第一状态变化到第二状态，即，被撑起来(即，处于填充状态或展开状态)，从而在所述外层覆膜300与所述内层覆膜200之间形成夹腔A。外层覆膜300如同口袋一般被结合到内层覆膜200。
在本申请的一些实施例中，内层覆膜200和/或外层覆膜300的材料为PET、ePTFE或Tpu(Thermoplastic polyurethanes，热塑性聚氨酯弹性体橡胶)中的至少一种。
需要说明的是，通过上述材料中的至少一种形成的外层覆膜300也具有一定的渗漏量，例如，大约在300ml/cm 2/min至1000ml/cm 2/min之间，但是由内层覆膜200穿入至内层覆膜200与外层覆膜300之间的夹腔A的流量、流速过小，使得该部分流体基本上不从外层覆膜300向腹主动脉瘤体的瘤腔中渗漏。即使存在渗漏，其渗漏量也很小，不会对人体产生影响，可以忽略不计。并且在术后一个月左右，由于覆膜材料的内皮化便不会再发生渗漏。此处需要说明的是，外层覆膜300与内层覆膜200之间所形成的夹腔A为封闭空间，即，除了因预设渗漏量产生的必要渗漏，形成夹腔A的外层覆膜300与内层覆膜200的部分上没有其他孔洞。例如，在如图1至图3中所示的根据本申请的第一实施例和第二实施例中所示，外层覆膜300上不形成任何孔洞。
可选地，内层覆膜200采用缝制或热熔的方式固定于金属支架100。可选地，外层覆膜300的近端、远端分别通过缝制和/或热熔的方式固定于内层覆膜200的外侧。可以理解的是，内层覆膜200整体与金属支架100连接，即以覆盖的方式设于金属支架100上。可选地，内层覆膜200位于金属支架100的内侧或外侧，外层覆膜300位于金属支架100的外侧。
在本申请的一些实施例中，例如，在如图4和图5所示的根据本申请的第三实施例和第四实施例中，内层覆膜200上设置有至少一个内脏动脉供血位；夹腔A的数目可以大于或等于2；夹腔A沿从内层覆膜200的近端至远端的方向依次分布且相邻两个夹腔A被一个或更多个内脏动脉供血位分隔开而分别位于所述内脏动脉供血位的远侧和近侧。
需要说明的是，内脏动脉供血位用于向双肾动脉、腹腔干、肠系膜上动脉等内脏动脉600供血。通过上述布置，可以保证覆膜支架在阻挡分支血管400中 的血流返流的前提下，也可以保证内脏动脉600的正常供血，从而避免引发严重的并发症。可选地，内层覆膜200的内脏动脉供血位处开设有通血窗口。虽然未详细示出，但是内层覆膜200可以进一步设置有嵌入在通血窗口处的内嵌分支。内嵌分支可以用于安装分支血管支架或直接形成为分支血管支架，分支血管支架用于向内脏动脉供血。
可选地，外层覆膜300的数目可以大于或等于2，每个外层覆膜300与内层覆膜200之间均形成有夹腔A。其中，外层覆膜300的数量与夹腔A的数量相同，即一个外层覆膜300对应一个夹腔A。
在本申请的另外一些实施例中，内层覆膜200上可以设置有至少一个内脏动脉供血位并且外层覆膜300与夹腔A的数目可以均为1个。在这种情况下，外层覆膜300上相应地具有至少一个供血窗口且外层覆膜300中位于供血窗口四周的部位可以被固定在内层覆膜200上，供血窗口与对应的内脏动脉供血位相通。
可选地，外层覆膜300中位于供血窗口四周的部位采用热熔和/或缝制的方式固定在内层覆膜200上。
在本申请的另外一些实施例中，也可以利用一个外层覆膜300形成两个或更多个夹腔A，其中，外层覆膜300在两个相邻的夹腔A之间的环形部分被采用热熔和/或缝制的方式固定在内层覆膜200上。与上面的实施例类似，可以在该环形部分中选择性地设置供血窗口以与内层覆膜200上的对应的内脏动脉供血位相通。相应地，外层覆膜300中位于设置的供血窗口周围的部位被固定在内层覆膜200上。另外，上述两个或更多个夹腔中的至少一个夹腔被填充或展开时可以覆盖相应的分支血管。
在本申请的一些实施例中，例如，在如图3至图5中所示的根据本申请的第二实施例、第三实施例和第四实施例中，覆膜支架包括主体覆膜支架和与主体覆膜支架的远端连接的分支覆膜支架。外层覆膜300的远端可以固定于分支覆膜支架的内层覆膜200上。需要说明的是，分支覆膜支架用于向髂动脉供血。如此，可以对位于腹部不同位置的腹主动脉瘤体进行治疗，以扩大覆膜支架的应用范围。可以理解的是，主体覆膜支架是指覆膜支架中未分叉的部分，分支覆膜支架是指覆膜支架中分叉的部分。
可选地，外层覆膜300的远端固定于分支覆膜支架的内层覆膜200的近端，或者固定于分支覆膜支架的内层覆膜200的中部，或者固定于分支覆膜支架的内层覆膜200的远端。需要说明的是，分支覆膜支架的内层覆膜200的中部是 指分支覆膜支架的内层覆膜200中位于近端与远端之间的部位。
可选地，外层覆膜300在被撑开时，其至少一部分能够形成动脉血管壁紧贴面F2(参见图3至图5)。当外层覆膜300被撑开时，动脉血管壁紧贴面F2可紧贴髂动脉500的内壁，由此可预防由覆膜支架的远端与髂动脉500贴合不紧密所引起的I型内漏。
外层覆膜300的设置数目和分布位置与分支覆膜支架的近端、分支血管400及内脏动脉600三者之间的位置关系有关，下面结合图2至图5进行具体说明：
(1)如图2所示，当分支覆膜支架的近端与髂动脉分叉点500a重合，且腹主动脉瘤体未累及内脏动脉600时，外层覆膜300的数目为一个并近端围设于主体覆膜支架的内层覆膜200的外侧而远端围设于分支覆膜支架的近端，同时覆盖分支血管400。需要指出的是，图2中所示出的外层覆膜300在被撑开时，自身的外表面构成了瘤腔壁紧贴面F1。
当内层覆膜200具有一定的渗漏量时，由于内层覆膜200术后短期内的渗漏，可以使得图2中自上而下的血流穿过内层覆膜200缓慢进入至内层覆膜200与外层覆膜300之间的夹腔A中，从而使外层覆膜300展开直至充满整个腹主动脉瘤体的瘤腔。这既可以覆盖腹主动脉瘤体上的分支血管400，从而阻挡分支血管400中的血流返流，预防Ⅱ型内漏，同时也可对由覆膜支架的近端、远端与主动脉血管贴合不紧密所引起的I型内漏起到一定的阻挡作用。不仅如此，流速缓慢的血流可使内层覆膜200与外层覆膜300之间的夹腔A内形成血栓，持续地预防Ⅱ型内漏发生。
(2)如图3所示，当分支覆膜支架的近端位于髂动脉分叉点500a上方，且腹主动脉瘤体未累及内脏动脉600时，外层覆膜300的数目可以仅为一个并且其近端围设于主体覆膜支架的内层覆膜200的外侧而其远端围设于分支覆膜支架的近端与髂动脉分叉点500a之间的部位。需要指出的是，图3中所示出的外层覆膜300在被撑开时，当以图3中所示的水平虚线为界线时，位于界线之上的外表面构成了瘤腔壁紧贴面F1，位于界线之下的外表面构成了动脉血管壁紧贴面F2。
同样地，当内层覆膜200具有一定的渗漏量时，那么在血流的作用下，外层覆膜300扩张填满整个腹主动脉瘤体的瘤腔并覆盖分支血管400，并逐渐在内层覆膜200和外层覆膜300之间所形成的夹腔A内产生血栓，由此可在近期和远期持续地预防II型内漏；同时，如前所述，对I型内漏也起到一定的阻挡作用。
(3)如图4所示，当分支覆膜支架的近端位于髂动脉分叉点500a上方，腹 主动脉瘤体累及内脏动脉600，且分支血管400分别位于内脏动脉600远端及近端时，外层覆膜300的数目可以为两个，即，外层覆膜300包括近端外层覆膜310和远端外层覆膜320。近端外层覆膜310围设于主体覆膜支架中位于内脏动脉600之上的部位，以覆盖对应的分支血管400。远端外层覆膜320的近端围设于分支覆膜支架的近端与内脏动脉600之间的部位、其远端围设于分支覆膜支架的近端与髂动脉分叉点500a之间的部位。需要指出的是，图4中所示出的近端外层覆膜310在被撑开(也可被称为展开)时，自身的外表面构成了瘤腔壁紧贴面F1。图4中所述示出的远端外层覆膜320在被撑开时，当以图4中所示的虚线为界线时，位于界线之上的外表面构成了瘤腔壁紧贴面F1，位于界线之下的外表面构成了动脉血管壁紧贴面F2。
该类结构的覆膜支架可以预防II型内漏。同时，随着近端外层覆膜310、远端外层覆膜320的逐渐扩张并贴紧腹主动脉瘤体的瘤腔内壁及髂动脉的血管壁，该类结构的覆膜支架也可预防I型内漏。
(4)如图5所示，当分支覆膜支架的近端位于髂动脉分叉点500a上方，腹主动脉瘤体累及内脏动脉600，且分支血管400位于内脏动脉600远侧、近侧同时位于分支覆膜支架的近端的下方时，外层覆膜300的数目可以为两个，即，外层覆膜300包括近端外层覆膜310和远端外层覆膜320。近端外层覆膜310围设于分支覆膜支架的近端与内脏动脉600之间的部位，而远端外层覆膜320围设于分支覆膜支架中位于内脏动脉600与髂动脉分叉点500a之间的部位。需要指出的是，图5中所示出的近端外层覆膜310在被撑开时，自身的外表面构成了动脉血管壁紧贴面F2。
图5中所示的这类结构的覆膜支架既可以预防II型内漏；同时，随着远端外层覆膜320的逐渐扩张并贴紧髂动脉内壁，可预防由覆膜支架的远端与血管贴合不紧所引起的I型内漏。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种覆膜支架，所述覆膜支架包括金属支架(100)和内层覆膜(200)，所述内层覆膜(200)被设置于所述金属支架(100)上并形成沿所述金属支架(100)的轴向贯通的内腔，其特征在于，所述覆膜支架还包括外层覆膜(300)，其中，
    所述外层覆膜(300)围设于所述内层覆膜(200)的外侧并能够相对于所述内层覆膜(200)从第一状态变化到第二状态，以在所述外层覆膜(300)与所述内层覆膜(200)之间形成夹腔(A)。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述外层覆膜(300)与所述内层覆膜(200)之间形成至少一个夹腔(A)，其中，所述外层覆膜(300)包括一个或多个外层覆膜。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述内层覆膜(200)具有预设渗漏量，所述预设渗漏量在300ml/cm 2/min至1000ml/cm 2/min的范围内。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述夹腔(A)中置有促血栓形成剂或绒毛。
  5. 根据权利要求1所述的覆膜支架，其特征在于，所述覆膜支架还包括置于所述夹腔(A)中的填充物，所述填充物用于支撑所述外层覆膜(300)至所述第二状态。
  6. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述外层覆膜(300)围绕所述内层覆膜(200)的阻隔部，并且所述外层覆膜(300)的近端、远端分别密封固定到所述内层覆膜；
    其中，所述外层覆膜(300)由柔性材料制成。
  7. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述内层覆膜(200)和/或所述外层覆膜(300)的材料包括PET、ePTFE或Tpu中的至少一种。
  8. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述外层覆膜(300)的近端和远端通过缝制和/或热熔的方式固定于所述内层覆膜(200)的外侧。
  9. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述内层覆膜(200)上设置有至少一个内脏动脉供血位；
    所述夹腔(A)的数目大于或等于2，所述夹腔(A)沿由所述内层覆膜(200)的近端至远端的方向依次分布且相邻两个夹腔(A)位于对应的内脏动脉供血位 的远侧和近侧。
  10. 根据权利要求9所述的覆膜支架，其特征在于，所述外层覆膜(300)的数目大于或等于2，每个所述外层覆膜(300)与所述内层覆膜(200)之间均形成有所述夹腔(A)。
  11. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述内层覆膜(200)上设置有至少一个内脏动脉供血位；
    所述外层覆膜(300)与所述夹腔(A)的数量均为1个，所述外层覆膜(300)上具有至少一个供血窗口且所述外层覆膜(300)中位于所述供血窗口周围的部位固定在所述内层覆膜(200)上，所述供血窗口与对应的所述内脏动脉供血位相通。
  12. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述内层覆膜(200)上设置有至少一个内脏动脉供血位；
    所述外层覆膜(300)的数量为1个，而所述夹腔(A)的数量为两个或更多个，其中，所述至少一个内脏动脉供血位中的至少一个内脏动脉供血位在相邻的两个夹腔(A)之间，其中，所述外层覆膜(300)上具有至少一个供血窗口，所述外层覆膜(300)中位于所述供血窗口周围的部位固定在所述内层覆膜(200)上，并且所述供血窗口与对应的所述内脏动脉供血位相通。
  13. 根据权利要求1-5任一项所述的覆膜支架，其特征在于，所述覆膜支架包括主体覆膜支架和与所述主体覆膜支架的远端连接的分支覆膜支架。
  14. 根据权利要求13任一项所述的覆膜支架，其特征在于，所述外层覆膜(300)的远端固定于所述分支覆膜支架或所述主体覆膜支架的内层覆膜(200)上。
  15. 根据权利要求13任一项所述的覆膜支架，其特征在于，所述外层覆膜(300)的近端固定于所述主体覆膜支架或所述分支覆膜支架的内层覆膜(200)上。
PCT/CN2021/143520 2021-01-05 2021-12-31 覆膜支架 WO2022148308A1 (zh)

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US20110022153A1 (en) * 2009-07-27 2011-01-27 Endologix, Inc. Stent graft
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