WO2022143097A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2022143097A1
WO2022143097A1 PCT/CN2021/136965 CN2021136965W WO2022143097A1 WO 2022143097 A1 WO2022143097 A1 WO 2022143097A1 CN 2021136965 W CN2021136965 W CN 2021136965W WO 2022143097 A1 WO2022143097 A1 WO 2022143097A1
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WO
WIPO (PCT)
Prior art keywords
stent
branch
main body
graft according
sealing member
Prior art date
Application number
PCT/CN2021/136965
Other languages
English (en)
French (fr)
Inventor
张宏鹏
王永胜
Original Assignee
杭州唯强医疗科技有限公司
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 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Publication of WO2022143097A1 publication Critical patent/WO2022143097A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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

Definitions

  • the invention relates to the field of medical devices, in particular to a covered stent.
  • Aortic aneurysm refers to the local or diffuse abnormal expansion of the aortic wall, which compresses the surrounding organs and causes symptoms, and the aneurysm rupture is the main risk. Commonly occurs in the ascending aorta, aortic arch, descending thoracic aorta, thoracoabdominal aorta, and abdominal aorta. Aortic aneurysms can be divided into true aortic aneurysms, pseudo-aortic aneurysms and dissecting aortic aneurysms according to their structure. Aortic aneurysm causes increased intravascular pressure, so it is progressively enlarged.
  • Aortic aneurysm disease may involve branch arteries, and once the branch arteries are involved, it will be difficult to solve by interventional methods.
  • arterial endovascular therapy has been carried out at home and abroad, that is, a minimally invasive method is used to treat arterial disease and improve blood supply by inserting a graft, or stent-graft, into the diseased artery with the help of the vascular lumen, so as to achieve the purpose of treatment.
  • the stent-graft When in use, the stent-graft is axially compressed and then loaded into the conveyor, which is sent to the diseased artery through the smaller femoral artery, iliac artery, and brachial artery and then released, due to the elastic effect of the stent-graft. It automatically restores to a straight tube shape and sticks to the inner wall of the aorta, isolating the diseased part of the artery from the blood flow, so as to achieve the purpose of treatment.
  • the existing covered stent Due to the limitation of the current stent structure, the existing covered stent has weak adherence to the aorta after release, and is easy to puncture the inner wall of the blood vessel in the ascending segment of the aorta, resulting in reverse tearing.
  • One object of the present invention is to provide a stent-graft, which can enhance the adherence to the ascending aorta, and can be combined with other stent-grafts by way of sleeve, so as to further improve the intervention of the ascending aorta. treatment effect.
  • the present invention provides a stent-graft, comprising:
  • the main body bracket is a tubular channel structure with a film covering on the side, and its proximal end is in the shape of a truncated cone;
  • the branch bracket is a tubular channel structure, which is attached to the inner wall of the main bracket, the channel direction is consistent with the channel direction of the main bracket, and the cavity is set in the channel of the main bracket.
  • the stent-graft of the present invention can better conform to the fluid mechanics and solid mechanics of the ascending aorta through the main body stent with a truncated proximal end, and is suitable for its tapered shape to enhance the The adherence between the stent-graft and the ascending aorta; and through the arrangement of the branch stents inside the main stent channel, the stent-graft of the present invention can be combined with other stent-grafts by way of splicing, so as to further improve the The effect of interventional therapy on the ascending aorta.
  • FIG. 1 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • FIG. 2 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • Fig. 3 shows a schematic structural diagram of the main stent in the stent graft according to an embodiment of the present invention.
  • Fig. 4 shows a schematic structural diagram of a branch stent in a stent graft according to an embodiment of the present invention.
  • Fig. 5 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • Fig. 6 shows a schematic top view of a stent graft according to an embodiment of the present invention.
  • Fig. 7 shows a schematic cross-sectional view of the distal end of the stent-graft according to one embodiment of the present invention.
  • FIG. 8 shows a schematic structural diagram of a sealing member according to an embodiment of the present invention.
  • FIG. 9 shows a schematic structural diagram of the provided stent-graft in cooperation with other stent-grafts according to an embodiment of the present invention.
  • Example embodiments will now be described more fully with reference to the accompanying drawings.
  • Example embodiments can be embodied in various forms and should not be construed as limited to the examples set forth herein; rather, these example embodiments are provided so that this description of the present invention will be thorough and complete, and will consolidate the concept of the example embodiments. It will be fully conveyed to those skilled in the art.
  • the drawings are merely schematic illustrations of the invention and are not necessarily drawn to scale.
  • the same reference numerals in the drawings denote the same or similar parts, and thus their repeated descriptions will be omitted.
  • the invention provides a covered stent, which can be used for interventional treatment of aortic diseases.
  • the end close to the heart in the blood flow direction is defined as the "proximal end”, and the end away from the heart in the blood flow direction is defined as the “distal end”.
  • the blood in the artery flows from the proximal end to the distal end.
  • a covered stent provided by the present invention includes a main stent and a branch stent.
  • the main body stent is a tubular channel structure with a film covering on the side, and the proximal end is in the shape of a truncated cone; that is, the diameter of the proximal end of the main body stent gradually increases and gradually expands outward.
  • the branch stent is a tubular channel structure, attached to the inner wall of the main stent, the channel direction of the branch stent is consistent with the channel direction of the main stent, and the cavity of the branch stent is set in the channel of the main stent; that is, the diameter of the branch stent is smaller than that of the main stent.
  • the branch stent may be a bare stent that only includes a support structure; it may also be a stent provided with a membrane on the side surface of the tubular channel enclosed by the support structure.
  • the stent-graft of the present invention can better conform to the fluid mechanics and solid mechanics of the ascending aorta through the main body stent with a truncated proximal end, and is suitable for its tapered shape to enhance the The adherence between the stent-graft and the ascending aorta; and through the arrangement of the branch stents inside the main stent channel, the stent-graft of the present invention can be combined with other stent-grafts by way of splicing, so as to further improve the The effect of interventional therapy on the ascending aorta.
  • the bus bar at the proximal end of the main body bracket is arc-shaped.
  • the proximal end of the main body stent is not only in the shape of a truncated cone with a gradually increasing diameter, but also has a gradually increasing diameter, so that the generatrix at the proximal end of the main body stent is in an arc shape.
  • the advantage of this embodiment is that the generatrix at the proximal end of the main stent is arc-shaped, which can further effectively prevent the stent from puncturing the intima of the blood vessel, thereby further avoiding the occurrence of reverse tearing.
  • the generatrix of the proximal end of the main body bracket is a straight line.
  • the distal end of the main body stent is cylindrical.
  • the distal end of the main body bracket is cylindrical, and the proximal end is truncated. That is, the distal end of the main stent is a channel structure with a constant diameter, and the proximal end is a channel structure whose diameter gradually increases and expands outward.
  • the covering of the main stent corresponding to the distal part is rectangular, and the covering of the main stent corresponding to the proximal part is trapezoidal.
  • the channel axis of the main body bracket refers to the extending direction of the channel surrounded by the main body bracket, and does not mean that the three-dimensional spatial structure of the main body bracket must be symmetrical to a certain line in the channel axis. That is, the main body support may be an asymmetric structure.
  • the distal end of the main body bracket and the proximal end of the main body bracket are in the shape of a truncated cone.
  • the distal end of the main body bracket and the proximal end thereof are in the shape of a truncated cone. That is, the diameter of the main body stent gradually increases from the distal end to the proximal end, and the whole of the main body stent is a channel structure that gradually expands outward. After the main body stent is axially cut and unfolded along the channel of the main body stent, the main body stent's covering film is in a trapezoid shape.
  • the included angle between the rotation axis of the proximal end of the main body bracket and the generatrix of the proximal end of the main body bracket ranges from 5° to 30°.
  • the proximal end of the main body bracket is in the shape of a truncated cone, and the angle between the rotation axis of the truncated truncated truncated truncated cone and the generatrix of the truncated truncated truncated cone ranges from 5° to 30°, including 5° and 30°.
  • the included angle between the generatrix and its rotational axis is the included angle between the two straight lines: between 5° and 30° (including 5° and 30°) an angle.
  • the angle between the generatrix and its rotation axis is the angle between a curve and a straight line: an angle interval that increases from angle A to angle B .
  • the minimum angle A is 5°
  • the maximum angle B is 30°.
  • FIG. 1 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • the stent-graft 100 includes a main stent 110 with a tubular channel structure and a branch stent 120 with a tubular channel structure.
  • the main body bracket 110 includes a main body covering film 111 and an annular main body supporting frame 112 fixed on the main body covering film 111 and arranged along the axis of the channel.
  • the two ends of the main body stent 110 are respectively the proximal end cavity 10 of the main body bracket and the distal end cavity 20 of the main body bracket.
  • the main body support frame 112 is fixed on the main body film 111 by sewing or heat pressing.
  • the main body cover 111 is supported by the main body support frame 112, so that the main body stent 110 can be expanded and maintained in a channel structure during use, so as to allow blood to pass through.
  • the main body support frame 112 includes four annular wave ring support frames arranged in sequence along the channel axis, and each wave ring support frame is composed of a plurality of continuous V-shaped support frames. Take the wave ring support frame closest to the distal end as the first wave ring support frame: starting from the third wave ring support frame, the diameter of the wave ring support frame gradually increases, so that the proximal end is truncated and the distal end is cylindrical. shaped body bracket 110 . Wherein, the included angle ⁇ between the rotation axis of the proximal end and the generatrix of the proximal end is an angle between 5° and 30°.
  • the two ends of the branch stent 120 are the proximal cavity of the branch stent and the distal cavity of the branch stent, respectively. Take the distal end as the low position and the proximal end as the high position: the distal cavity of the branch stent is lower than or flat to the distal cavity of the main stent 10; the proximal end is regarded as the low position, and the distal end is regarded as the high position: the proximal end of the branch stent
  • the orifice is lower than or level with the proximal end orifice 20 of the main body stent.
  • FIG. 2 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • the distal end of the main body bracket 110 and the proximal end of the main body bracket 110 are in the shape of a truncated cone.
  • the diameter of the wave ring support frame gradually increases, thereby obtaining the main body stent 110 in the shape of a truncated cone as a whole.
  • the included angle ⁇ between the rotation axis of the main body bracket 110 and the generatrix of the main body bracket 110 is an angle between 5° and 30°.
  • At least one side surface of the main body bracket is arc-shaped.
  • the ascending segment of the aorta is curved to one side
  • at least one side of the main body stent is curved and set in an arc shape to enhance the adhesion to the ascending segment of the aorta. wall.
  • the covering of the main stent is approximately trapezoidal, the bottom edge of the corresponding distal end is not parallel to the base edge of the corresponding proximal end, and the side corresponding to the inward curved side is not parallel.
  • the side lengths are shorter than the side lengths of their corresponding outwardly curved sides.
  • the main body bracket includes at least two wave ring support frames surrounding the channel axis of the main body frame, and each wave ring support frame is obtained by connecting at least two V-shaped brackets.
  • each wave ring support frame is obtained by connecting at least two V-shaped brackets.
  • a large curved side is formed on the opposite side, thereby obtaining a main body bracket with at least one side side curved.
  • the main body bracket includes at least two wave ring support brackets surrounding the channel axis of the main body bracket, and each wave ring support bracket is obtained by connecting at least two V-shaped brackets.
  • the stents there is at least one high-wave bare stent covered for protruding.
  • the wave coil support frame closest to the distal end of the main body stent there is at least one high wave bare stent protruding from the coating of the main body stent (ie, not covered by the coating of the main body stent) , and other covered stents that do not protrude from the main stent are called low-wave stents.
  • the wave coil support frame closest to the proximal end of the main body stent there is also at least one high wave bare stent protruding from the coating of the main body frame.
  • the advantage of this embodiment is that, through the arrangement of the high-wave bare stent, the stent-graft can be well matched with the blood vessel wall after release, and the firmness of the cooperation between the stent-graft and the blood vessel wall is improved.
  • FIG. 3 only exemplarily shows the main body stent of the stent-graft in an embodiment of the present invention.
  • the main body stent can be similar to The method cooperates with the branch stent of the stent-graft provided by the present invention.
  • three high wave bare stents are arranged at equal intervals.
  • the high-wave bare stent is curved toward the inside of the channel of the main stent.
  • the high-wave bare stent protruding from the coating will directly contact the local position of the blood vessel wall, it is bent to the inside of the channel, so as to prevent the top of the high-wave bare stent from piercing the blood vessel wall.
  • the cavity of the branch bracket is inclined to the channel direction of the branch bracket, wherein the side of the cavity of the branch bracket close to the inner wall of the main bracket is lower than the side away from the inner wall of the main bracket.
  • the angle between the plane where the cavity of the branch support is located and the axis of the channel of the branch support is not equal to 90°.
  • the branch bracket is attached to the inner wall of the main bracket. Based on the inner wall of the main bracket, the cavity of the branch bracket is divided into two sides: the side close to the inner wall of the main bracket and the side away from the inner wall of the main bracket. Take the proximal end of the branch support as the low position and the distal end of the branch support as the high position: the side close to the inner wall of the main body support is lower than the side away from the inner wall of the main body support.
  • the advantage of this embodiment is that the side of the oblique branch stent close to the inner wall of the main stent is lower, which facilitates the assembly of the stent on the one hand, and facilitates the establishment of the embedded branch stent after the main stent is released in the blood vessel. channel and connect additional branch supports.
  • a circular ring structure or an elliptical ring structure is embedded in the cavity of the branch stent.
  • the embedded circular ring structure or elliptical ring structure provides support for the cavity of the branch support and improves the structural stability of the branch support.
  • an elliptical ring structure is embedded in the cavity of the branch stent.
  • the distal end of the branch stent is provided with an orifice support frame for supporting the distal lumen of the branch stent.
  • the distal end of the branch stent is provided with an oral support frame.
  • the orifice support is erected on the surface of the tubular channel of the branch stent, and is connected with the distal lumen of the branch stent to provide support for the distal lumen of the branch stent.
  • the cavity support frame is a wave ring support frame composed of a plurality of continuous V-shaped rigid structures.
  • FIG. 4 shows a schematic structural diagram of a branch stent in a stent graft according to an embodiment of the present invention.
  • the cavity of the branch support is inclined to the channel direction of the branch support, and the cavity is embedded with an elliptical ring structure.
  • a wave ring support frame composed of a plurality of continuous V-shaped rigid structures is arranged in the middle section of the channel of the branch stent; and an orifice support frame 35 is arranged at the distal cavity of the branch stent.
  • the oral support frame 35 includes a high wave support rod 351 at a high position and a low wave support rod 352 at a low position.
  • the high wave support rod 351 and the low wave support rod 352 form a V-shaped rigid structure to provide support for the distal cavity of the branch stent.
  • the elliptical ring structure, the wave ring support frame and the cavity support frame 35 together provide support for the branch stent, ensuring the structural stability of the branch stent.
  • the branch support includes a first branch support and a second branch support.
  • the number of branch supports is two, which are respectively denoted as a first branch support and a second branch support.
  • the two branch stents jointly provide support for the combination of the stent-graft and another stent-graft.
  • each vertical tubular channel structure There are two branch brackets 120 , and the branch brackets 120 of each vertical tubular channel structure are matched with the cylindrical structure at the distal end of the main body bracket 110 , and are closely attached to the inner wall of the distal end of the main body bracket 110 , and the channel direction is the same as that of the main body bracket 110 . The direction of the channel remains the same.
  • each vertical tubular channel structure is attached to the inner wall of the distal end of the main body stent 110 in a suspended manner in a partially contacting manner with the inner wall of the distal end of the main body stent 110 , and the channel The direction is consistent with the channel direction of the main body bracket 110 .
  • the first branch support is tangent to the second branch support.
  • the first branch support is disposed adjacent to the second branch support. While being attached to the inner wall of the main body bracket, the channel of the first branch bracket is tangent to the surface of the channel of the second branch bracket.
  • the two branch brackets 120 are attached to the inner wall of the main bracket 110 side by side, and are tangent to a straight line on the side surface of the channel that is in contact with each other.
  • a distance is left between the first branch support and the second branch support.
  • the stent-graft further includes: a sealing member, the sealing member is disposed in the channel of the main stent, and the sealing area enclosed with the inner wall of the main stent includes a distal cavity with the branch stent as the symmetrical center and including the branch stent. mouth area.
  • the stent-graft including the main stent and the branch stent further includes a sealing member.
  • the seal is used to seal the gap created by the mating of the branch bracket with the main body bracket.
  • the sealing member is arranged in the channel of the main body bracket and is in contact with the inner wall of the main body bracket.
  • the sealing member and the inner wall of the main stent together enclose a sealing area on the plane where the distal cavity of the branch stent is located.
  • the sealing area includes an area with the branch stent as the center of symmetry and including the distal cavity of the branch stent.
  • the sealing member seals the distal cavity of the branch stent and seals the distal gap between the branch stent and the inner wall of the main stent, thereby realizing the sealing of the distal gap outside the blood flow channel of the stent-graft.
  • the advantage of this embodiment is that the sealing member seals the distal gap outside the blood flow channel of the stent-graft, avoiding the occurrence of blood endoleak.
  • the sealing area further includes an area with the branch stent as the center of symmetry and including the proximal lumen of the branch stent.
  • the sealing member, the inner wall of the main stent, and the plane where the proximal end cavity of the branch stent is located together enclose the sealing area.
  • the sealing area includes an area with the branch stent as the center of symmetry and including the proximal cavity of the branch stent. Therefore, the sealing member seals the proximal cavity of the branch stent and seals the proximal gap between the branch stent and the inner wall of the main stent, thereby realizing the sealing of the proximal gap outside the blood flow channel of the stent graft.
  • the advantage of this embodiment is that while the sealing member seals the distal gap outside the blood flow channel of the stent-graft, it also seals the proximal gap outside the stent-graft blood flow channel. Through the double-layer sealing, the occurrence of blood endoleak is further avoided.
  • the sealing member includes a first sealing member and a second sealing member which are symmetrically located on both sides of the branch support, are attached to the inner wall of the main body support, and have a triangular prism structure with a film on the sides.
  • a membrane is provided from the distal cavity of the first sealing element to the distal cavity of the branch stent and then to the distal cavity of the second sealing element.
  • the number of seals is two, which are respectively denoted as the first seal and the second seal.
  • the first sealing member and the second sealing member are symmetrically located on both sides of the branch support, both are attached to the inner wall of the main body support, and both are triangular prism structures with films on the sides.
  • a membrane is provided from the distal cavity of the first sealing member to the distal cavity of the branch stent and then to the distal cavity of the second sealing member, so as to seal the distal gap outside the blood flow channel of the stent-graft.
  • FIG. 5 shows a schematic structural diagram of a stent graft according to an embodiment of the present invention.
  • the stent-graft 100 not only includes the main stent 110 and the branch stent 120 , but also includes two sealing members 130 having a triangular prism structure.
  • the two seals 130 are symmetrically arranged on both sides of the branch support 120 , and are attached to the inner wall of the main support 110 and the adjacent branch support 120 at the same time.
  • the region between the distal cavities of the two seals 130 including the region where the distal cavities of the branch stent 120 are located is provided with a covering film, so as to seal the distal gap outside the blood flow channel of the covered stent 100 .
  • FIG. 6 shows a schematic top view of the stent graft according to an embodiment of the present invention.
  • the distal cavities 30 of the branch stent and the distal cavities of the seals 130 on both sides are located on the same plane, and are sealed by the distal end covering 50 at the distal end .
  • the distal cavity 20 of the main stent is obtained under the enclosure of the distal covering 50 and the inner wall of the main stent 110, so that other covered stents can be sleeved on the distal cavity 20 of the main stent to communicate with the covering.
  • Matching brackets are provided.
  • branch support frame 122 of the branch stent is fixed on the branch membrane 121 by sewing or heat pressing.
  • the membrane provided from the distal cavity of the first sealing member to the distal cavity of the branch stent and then to the distal cavity of the second sealing member is crescent-shaped.
  • the sealing member has a crescent shape in the sealing region at the distal end.
  • the three sides of the triangular prism structure are respectively denoted as: the first side attached to the inner wall of the main support, the second side parallel to the branch support, and the third side away from the inner wall of the main support.
  • the sealing area at the distal end of the sealing element is in a crescent shape, that is, the third side surface of the triangular prism structure is a curved surface.
  • the third side surface of the first sealing member and the third side surface of the second sealing member are both tangent to the branch support, and the tangent line is a straight line formed by the farthest point of the channel surface of the branch support from the inner wall of the main body support.
  • the advantage of this embodiment is that the curved third side surface of the triangular prism structure seal can be closely attached to other stent-grafts, avoiding the generation of gaps between the branched stent and other stent-grafts, thereby further avoiding the occurrence of blood endoleak.
  • FIG. 7 shows a schematic cross-sectional view of the distal end of the stent graft according to an embodiment of the present invention.
  • the distal cross-section of the stent-graft 100 is composed of the distal cross-section of the peripheral body stent, the distal cross-section of the inner seal, and the distal cross-section of the inner branch stent.
  • the cross section of the distal end of the sealing element is in the shape of a tine
  • the cross section of the distal end of the branch stent is in the shape of a circle.
  • the region formed by the distal cross-section of the symmetrically distributed seals and the distal cross-section of the branch stent located at the center of symmetry is crescent-shaped.
  • the crescent-shaped region in the distal cross section of the main body stent is the distal cavity of the main body stent.
  • the stent-graft is matched with other stent-grafts at the distal cavity of the main stent. Since the cross section of the distal end of the sealing element is in the shape of a tine, that is, the third side surface of the sealing element away from the inner wall of the main body bracket is a curved surface.
  • the third side surface can be closely attached to other stent-grafts, so as to avoid the generation of gaps between the branch stent and other stent-grafts, thereby further avoiding the occurrence of blood endoleak.
  • the incision of the branch stent and the crescent-shaped area ensures the sealing effect, so that the cavity of the branch stent can be in direct contact with other stent-grafts, which ensures the stability of the support provided by the branch stent.
  • the covering film attached to the side surface of the main body bracket of the sealing member includes the covering film of the main body bracket.
  • the sealing member is a triangular prism structure
  • the covering film attached to the side surface of the main body bracket includes the covering film of the main body bracket.
  • the side attached to the main body bracket is denoted as the first side surface, that is, the first side surface of the first sealing member shares the film with the main body bracket; the first side surface of the second sealing member shares the film with the main body bracket.
  • the advantage of this embodiment is that the use of material is saved by sharing the cover of the first side of the seal with the main body stent.
  • the coating provided on the side surface of the sealing member attached to the main body bracket further includes a supplementary coating.
  • the sealing element has a triangular prism structure
  • the coating provided on the first side surface includes a supplementary coating in addition to the coating of the main frame. That is, the first side of the first seal shares the film with the main body support, and is also provided with a second layer of supplementary film; the first side of the second seal shares the film with the main support, and is also provided with a second layer of supplementary film; layer of supplementary lamination.
  • the advantage of this embodiment is that a second layer of supplementary coating is further provided on the basis of the shared coating on the first side surface of the sealing element and the main body bracket, which improves the structural stability and sealing effect of the sealing element.
  • the membrane provided on the side of the sealing member parallel to the branch stent includes the membrane of the branch stent.
  • the sealing member is a triangular prism structure, and the coating provided on the side surface parallel to the channel direction of the branch stent includes the coating of the branch stent.
  • the side parallel to the branch stent is denoted as the second side, that is, the second side of the first seal shares the film with the branch stent; the second side of the second seal shares the film with the branch stent.
  • An advantage of this embodiment is that the use of material is saved by sharing the cover of the second side of the seal with the main body stent.
  • the covering film provided on the side of the sealing member parallel to the branch stent further includes a supplementary covering film.
  • the sealing member is a triangular prism structure, and the coating provided on the second side surface includes the coating of the branch stent, and also includes the supplementary coating. That is, the second side of the first seal shares the film with the main body support, and is also provided with a second layer of supplementary film; the second side of the second seal shares the film with the main support, and is also provided with a second layer of supplementary film; layer of supplementary lamination.
  • the advantage of this embodiment is that a second layer of supplementary coating is further provided on the basis of the shared coating on the second side of the sealing element and the main body bracket, which improves the structural stability and sealing effect of the sealing element.
  • FIG. 8 shows a schematic structural diagram of a sealing member according to an embodiment of the present invention.
  • the sealing member 130 of the triangular prism structure located on the left side of the branch stent includes an upper side surface 131 located at the distal end cavity thereof, a right side surface 132 attached to the branch stent, and an outer side surface 133 attached to the main body stent , the inner side 134 of the inner wall away from the main body stent and the lower side 135 of the proximal cavity.
  • the right side 132 of the seal can share the film with the branch support, and a second layer of supplementary film can be further provided on this basis; in the same way, the outer side of the seal can share the film with the theme home, On this basis, a second layer of supplementary film can be further provided.
  • the seal consists of a support structure and a membrane.
  • the triangular prism structure of the sealing element is formed by a soft covering film enclosed under the support of the support structure.
  • the texture of the support structure is more rigid than that of the film.
  • the sealing member may be formed only by a soft covering, thereby effectively reducing the diameter of the sheath tube and ensuring the overall flexibility of the stent.
  • the seal is hollow inside.
  • the interior of the sealing member of the triangular prism structure is hollow.
  • the advantage of this embodiment is that the seal is hollow inside, reducing the mass of the seal.
  • the interior of the seal is filled with an expandable material.
  • the interior of the sealing member of the triangular prism structure is filled with an expandable material, such as hydrogel.
  • the advantage of this embodiment is that the seal is more stable in structure under the support of the expandable material filled in the interior.
  • FIG. 9 shows a schematic structural diagram of the cooperation of a stent-graft provided with other stent-grafts according to an embodiment of the present invention.
  • the stent-graft 100 is combined with other stent-grafts 800 under the support of two branch stents attached to the inner wall of the main stent.
  • the distal cavity 30 of the branch stent and the distal cavities of the sealing members 130 on both sides are sealed by the distal end covering 50 at the distal end, so that the distal gap between the branch stent and the main stent is sealed, avoiding Endoleak of blood.
  • the distal cavity 20 of the main body stent is obtained under the enclosure of the distal end covering 50 and the inner wall of the main body stent 110 .
  • the other stent-grafts 800 cooperate with the stent-graft 100 by being sleeved on the distal cavity 20 of the main stent. Since the inner side of the sealing member 130 away from the inner wall of the main stent is a curved surface, the inner side of the sealing member can be closely attached to the other stent-grafts 800, thereby avoiding the generation of a gap between the branch stent and the other stent-grafts 800, and further avoiding endoleak of blood.

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Abstract

一种覆膜支架（100），包括：主体支架（110），所述主体支架（110）为侧面设有覆膜（111）的管状通道结构，其近端呈圆台状；分支支架（120），所述分支支架（120）为管状通道结构，其贴附于所述主体支架（110）的内壁，其通道方向与所述主体支架（110）的通道方向一致，且其腔口设于所述主体支架（110）的通道。所述的覆膜支架（100）能够增强与主动脉升段的贴壁性，并能够与其他覆膜支架（100）通过套接的方式进行组合，从而能够进一步提高对主动脉升段的介入治疗效果。

Description

覆膜支架
本申请基于并要求2020年12月31日申请的、申请号为202011626301.7、名称为“覆膜支架”的中国专利申请的优先权，其全部内容在此并入作为参考。
技术领域
本发明涉及医疗器械领域，具体涉及一种覆膜支架。
 背景技术
主动脉瘤是指主动脉壁局部或弥漫性的异常扩张，压迫周围器官而引起症状，瘤状破裂为其主要危险。常发生在升主动脉主动脉弓、胸部降主动脉、胸腹主动脉和腹主动脉。主动脉瘤按结构可分为真性主动脉瘤、假性主动脉瘤和夹层主动脉瘤。主动脉瘤引起血管内侧压增高，故呈进行性膨大，若长期发展，最后终归破裂，瘤体越大，破裂的可能性越大。栓塞为另一并发症。据统计，若不作手术治疗，90%胸主动脉瘤在5年内死亡，3/4腹主动脉瘤在5年内死亡。
主动脉瘤疾病均有可能涉及到分支动脉，一旦涉及到分支动脉想通过介入方法解决就会举步维艰。目前现国内外已开展了动脉腔内治疗术，即采用微创方法，借助血管腔道向病变动脉内置入移植物既动脉覆膜支架来治疗动脉疾病改善供血，从而达到治疗目的。使用时将动脉覆膜支架轴向压缩后装载于输送器中，由输送器通过较小的股动脉、髂动脉、肱动脉送到病变动脉处再将其释放，由于动脉覆膜支架的弹力作用自动恢复成直管状并紧贴于主动脉内壁，将动脉病变部位与血流隔离，从而达到了治疗目的。
受到目前支架结构的限制，现有的覆膜支架在释放后与主动脉贴壁性弱，易刺破主动脉升段的血管内壁，造成逆撕。
 技术问题
本发明的一个目的在于提供一种覆膜支架，增强与主动脉升段的贴壁性，并能够与其他覆膜支架通过套接的方式进行组合，从而能够进一步提高对主动脉升段的介入治疗效果。
 技术解决方案
为解决上述技术问题，本发明提供一种覆膜支架，包括：
主体支架，所述主体支架为侧面设有覆膜的管状通道结构，其近端呈圆台状；
分支支架，所述分支支架为管状通道结构，其贴附于所述主体支架的内壁，其通道方向与所述主体支架的通道方向一致，且其腔口设于所述主体支架的通道。
 有益效果
本发明的实施例提供的技术方案可以包括以下有益效果：
由于主动脉升段的近端直径较粗，因此本发明的覆膜支架通过近端呈圆台状的主体支架能够更加符合主动脉升段处的流体力学和固体力学，适用其锥形形态，增强覆膜支架与主动脉升段的贴壁性；而且通过主体支架通道内部的分支支架的设置，使得本发明的覆膜支架能够与其他覆膜支架通过套接的方式进行组合，从而能够进一步提高对主动脉升段的介入治疗效果。
本发明的其他特性和优点将通过下面的详细描述变得显然，或部分地通过本发明的实践而习得。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性的，并不能限制本发明。
 附图说明
通过参考附图详细描述其示例实施例，本发明的上述和其它目标、特征及优点将变得更加显而易见。
图1示出了根据本发明一个实施例的覆膜支架的结构示意图。
图2示出了根据本发明一个实施例的覆膜支架的结构示意图。
图3示出了根据本发明一个实施例的覆膜支架中主体支架的结构示意图。
图4示出了根据本发明一个实施例的覆膜支架中分支支架的结构示意图。
图5示出了根据本发明一个实施例的覆膜支架的结构示意图。
图6示出了根据本发明一个实施例的覆膜支架的俯视结构示意图。
图7示出了根据本发明一个实施例的覆膜支架的远端横截面示意图。
图8示出了根据本发明一个实施例的密封件的结构示意图。
图9示出了根据本发明一个实施例的所提供的覆膜支架与其他覆膜支架配合的结构示意图。
附图标记说明：
100-覆膜支架；110-主体支架；111-主体覆膜；112-主体支撑架；10-主体支架的近端腔口；20-主体支架的远端腔口；120-分支支架；121-分支覆膜；122-分支支撑架；35-腔口支撑架；351-高波支撑杆；352-低波支撑杆；130-密封件；131-上侧面；132-右侧面；133-外侧面；134-内侧面；135-下侧面；50-远端覆膜；800-其他覆膜支架。
 本发明的实施方式
现在将参考附图更全面地描述示例实施方式。然而，示例实施方式能够以多种形式实施，且不应被理解为限于在此阐述的范例；相反，提供这些示例实施方式使得本发明的描述将更加全面和完整，并将示例实施方式的构思全面地传达给本领域的技术人员。附图仅为本发明的示意性图解，并非一定是按比例绘制。图中相同的附图标记表示相同或类似的部分，因而将省略对它们的重复描述。
本发明提供一种覆膜支架，可用于主动脉疾病介入治疗。
需要说明的是，本发明中，将沿血流方向靠近心脏的一端定义为“近端”，将沿血流方向远离心脏的一端定义为“远端”。其中，动脉内血液是由近端向远端流动的。
本发明所提供的一种覆膜支架包括主体支架以及分支支架。主体支架为侧面设有覆膜的管状通道结构，且近端呈圆台状；即：主体支架近端的直径逐渐增大，逐渐向外扩张。分支支架为管状通道结构，贴附于主体支架的内壁，分支支架的通道方向与主体支架的通道方向一致，且分支支架的腔口设于主体支架的通道；即：分支支架的直径小于主体支架的直径，在保持通道方向一致的同时贴附于主体支架的内壁，而且分支支架的腔口低于或平于主体支架的腔口（当以远端为低位以近端为高位时，分支支架的近端腔口低于或平于主体支架的近端腔口；当以近端为低位以远端为高位时，分支支架的远端腔口低于或平于主体支架的远端腔口）。其中，分支支架可以为仅包括支撑结构的裸支架；也可以为在支撑结构所合围的管状通道侧面上设有覆膜的支架。
由于主动脉升段的近端直径较粗，因此本发明的覆膜支架通过近端呈圆台状的主体支架能够更加符合主动脉升段处的流体力学和固体力学，适用其锥形形态，增强覆膜支架与主动脉升段的贴壁性；而且通过主体支架通道内部的分支支架的设置，使得本发明的覆膜支架能够与其他覆膜支架通过套接的方式进行组合，从而能够进一步提高对主动脉升段的介入治疗效果。
在一实施例中，主体支架的近端的母线呈弧形。
该实施例中，主体支架的近端不仅呈直径逐渐增大的圆台状，而且直径的增大幅度逐渐提高，使得主体支架的近端的母线呈弧形。
该实施例的优点在于，主体支架的近端的母线呈弧形能够进一步有效避免支架刺破血管内膜，从而进一步避免逆撕的发生。
可选的，在其他实施例中，主体支架的近端的母线为直线。
在一实施例中，主体支架的远端呈圆柱状。
该实施例中，主体支架的远端呈圆柱状，近端呈圆台状。即：主体支架的远端为直径不变的通道结构，近端为直径逐渐增大向外逐渐扩张的通道结构。沿主体支架的通道轴向剖开并展开主体支架的覆膜后，对应远端部分的主体支架的覆膜呈矩形，对应近端的主体支架的覆膜呈梯形。
需要说明的是，主体支架的通道轴向指的是主体支架所围设通道的延伸方向，并不代表主体支架的立体空间结构一定对称于其通道轴向上的某一条线。即，主体支架可以为非对称结构。
在一实施例中，主体支架的远端配合主体支架的近端呈圆台状。
该实施例中，主体支架的远端配合其近端呈圆台状。即：主体支架从远端至近端直径逐渐增大，主体支架的整体为向外逐渐扩张的通道结构。沿主体支架的通道轴向剖开并展开主体支架的覆膜后，主体支架的覆膜呈梯形。
在一实施例中，主体支架的近端的旋转轴与主体支架的近端的母线间的夹角范围为5°～30°。
该实施例中，主体支架的近端呈圆台状，且该圆台的旋转轴与该圆台的母线间的夹角范围为5°～30°，包含5°以及30°。
具体的，当该圆台状近端的母线为直线时，其母线与其旋转轴间的夹角为两条直线之间的夹角：5°到30°之间（包含5°以及30°）的一个角度。
当该圆台状近端的母线为呈弧形的曲线时，其母线与其旋转轴间的夹角为一条曲线与一条直线之间的夹角：从角度A不断增大到角度B的一个角度区间。其中，角度A最小为5°，角度B最大为30°。
图1示出了本发明一实施例的覆膜支架的结构示意图。
该实施例中，覆膜支架100包括管状通道结构的主体支架110与管状通道结构的分支支架120。
主体支架110包括主体覆膜111、固定在主体覆膜111上沿通道轴线排布的环形的主体支撑架112。在主体支架110的两端分别为主体支架的近端腔口10以及主体支架的远端腔口20。
其中，主体支撑架112通过缝合或热压的方式固定在主体覆膜111上。通过主体支撑架112支撑主体覆膜111，以使主体支架110在使用时能够展开并保持为通道结构，从而供血液通过。
具体的，该实施例中，主体支撑架112包括四个沿通道轴线依次排布的环形的波圈支撑架，每个波圈支撑架由多个连续的V形支架组成。以最接近远端的波圈支撑架为第一个波圈支撑架：从第三个波圈支撑架开始，波圈支撑架的直径逐渐增大，从而得到近端呈圆台状远端呈圆柱状的主体支架110。其中，近端的旋转轴与近端的母线的夹角α为5°～30°中的一个角度。
在分支支架120的两端分别为分支支架的近端腔口以及分支支架的远端腔口。以远端为低位，以近端为高位：分支支架的远端腔口低于或平于主体支架的远端腔口10；以近端为低位，以远端为高位：分支支架的近端腔口低于或平于主体支架的近端腔口20。
图2示出了本发明一实施例的覆膜支架的结构示意图。
该实施例中，主体支架110的远端配合主体支架110的近端呈圆台状。以最接近远端的波圈支撑架为第一个波圈支撑架：从第一个波圈支撑架开始，波圈支撑架的直径便逐渐增大，从而得到整体呈圆台状的主体支架110。其中，主体支架110的旋转轴与主体支架110的母线的夹角α为5°～30°中的一个角度。
在一实施例中，主体支架至少一侧的侧面呈弧形。
具体的，考虑到主动脉上升段向一侧弯曲，为了良好地与主动脉上升段贴合，将主体支架至少一侧的侧面弯曲，设置为呈弧形，以增强与主动脉上升段的贴壁性。沿侧面的弯曲方向剖开并展开主体支架的覆膜后，主体支架的覆膜呈近似的梯形，其对应远端的底边与其对应近端的底边不平行，其对应内弯侧的侧边长度短于其对应外弯侧的侧边长度。
其中，主体支架包含至少两个环绕主体支架的通道轴向的波圈支撑架，各个波圈支撑架由至少两个V形的支架连接得到。沿主体支架侧面上的目标方向，逐渐缩小波圈支撑架中V形支架之间的波间距，使得波圈支撑架向该目标方向收缩，在该目标方向形成小弯侧，在该目标方向的对面形成大弯侧，从而得到至少一侧的侧面弯曲的主体支架。
在一实施例中，主体支架包含至少两个环绕主体支架的通道轴向的波圈支撑架，各个波圈支撑架由至少两个V形的支架连接得到，在位于主体支架端口的波圈结构的支架中，至少有一个为突出所设覆膜的高波裸支架。
具体的，参考图3所示，主体支架中距离远端最近的波圈支撑架中，设有至少一个突出主体支架的覆膜（即，不被主体支架的覆膜所覆盖）的高波裸支架，其他未突出主体支架的覆膜的支架则被称为低波支架。同理，主体支架中距离近端最近的波圈支撑架中，同样设有至少一个突出主体支架的覆膜的高波裸支架。
该实施例的优点在于，通过高波裸支架的设置，使得覆膜支架在释放后能够良好地与血管壁相配合，提高了覆膜支架与血管壁配合的牢固性。
需要说明的是，图3只是示例性示出了本发明一实施例中的覆膜支架的主体支架，参照本发明其他部分所展示主体支架与分支支架相互配合的方式，该主体支架可以按照类似的方式与本发明所提供覆膜支架的分支支架相互配合。
在一实施例中，在位于主体支架端口的波圈支撑架中，等间距地设有三个高波裸支架。
在一实施例中，高波裸支架向主体支架的通道内侧弯曲。
具体的，考虑到突出覆膜的高波裸支架会直接与血管壁的局部位置相接触，将其向通道内侧弯曲，从而避免高波裸支架的顶端刺破血管壁。
在一实施例中，分支支架的腔口倾斜于分支支架的通道方向，其中，分支支架的腔口靠近主体支架的内壁的一侧低于远离主体支架的内壁的一侧。
该实施例中，分支支架的腔口所在平面与分支支架的通道轴线间的角度不等于90°。分支支架贴附于主体支架的内壁，以主体支架的内壁为基准，分支支架的腔口被划分为两侧：靠近主体支架的内壁的一侧、远离主体支架的内壁的一侧。以分支支架的近端为低位，以分支支架的远端为高位：靠近主体支架的内壁的一侧低于远离主体支架的内壁的一侧。
该实施例的优点在于，倾斜的分支支架的腔口靠近主体支架的内壁的一侧较低这一结构，一方面便于装配支架，另一方面主体支架在血管内释放后便于内嵌分支支架建立通道以及连接另外的分支支架。
在一实施例中，分支支架的腔口内嵌圆环结构或椭圆环结构。
该实施例中，分支支架的腔口在倾斜于分支支架的通道方向的同时，内嵌圆环结构或椭圆环结构为分支支架的腔口提供支撑，提高分支支架的结构稳定性。优选的，分支支架的腔口内嵌椭圆环结构。
在一实施例中，分支支架的远端设有腔口支撑架，用于支撑分支支架的远端腔口。
该实施例中，分支支架的远端设有腔口支撑架。该腔口支撑架设于分支支架的管状通道表面，并与分支支架的远端腔口相连，为分支支架的远端腔口提供支撑。可选的，该腔口支撑架为多个连续V形刚性结构组成的波圈支撑架。
图4示出了本发明一实施例的覆膜支架中分支支架的结构示意图。
参考图4所示，该实施例中，分支支架的腔口倾斜于分支支架的通道方向，且其腔口内嵌椭圆环结构。在该分支支架的通道中间段设有由多个连续V形刚性结构组成的波圈支撑架；且在该分支支架的远端腔口设有腔口支撑架35。以近端为低位，以远端为高位：该腔口支撑架35包括处于高位的高波支撑杆351以及处于低位的低波支撑杆352。高波支撑杆351与低波支撑杆352组成V形刚性结构，为该分支支架的远端腔口提供支撑。
椭圆环结构、波圈支撑架以及腔口支撑架35共同为分支支架提供支撑，保证分支支架的结构稳定性。
在一实施例中，分支支架包括第一分支支架以及第二分支支架。
该实施例中，分支支架的数量为二，分别记为第一分支支架以及第二分支支架。通过该两个分支支架共同为该覆膜支架与另一覆膜支架的组合提供支撑。
具体的，参考图1所示。分支支架120有两个，每个竖直的管状通道结构的分支支架120均配合主体支架110远端的圆柱结构，紧密贴附于主体支架110的远端的内壁，且通道方向与主体支架110的通道方向保持一致。
或者，参考图2所示。分支支架120有两个，每个竖直的管状通道结构的分支支架120均以与主体支架110的远端的内壁局部接触的悬挂方式，贴附于主体支架110的远端的内壁，且通道方向与主体支架110的通道方向保持一致。
在一实施例中，第一分支支架与第二分支支架相切。
该实施例中，第一分支支架与第二分支支架相邻设置。在贴附于主体支架的内壁的同时，第一分支支架的通道与第二分支支架的通道表面相切。
具体的，参考图1或图2所示。两个分支支架120并列贴附于主体支架110的内壁，并相切于相互接触到的通道侧面的一条直线。
可选的，在其他实施例中，第一分支支架与第二分支支架之间留有间距。
在一实施例中，覆膜支架还包括：密封件，密封件设于主体支架的通道中，其与主体支架的内壁合围的密封区域包括以分支支架为对称中心且包含分支支架的远端腔口的区域。
该实施例中，包括主体支架以及分支支架的覆膜支架还包括密封件。该密封件用于密封由于分支支架与主体支架相配合所产生的空隙。具体的，该密封件设于主体支架的通道中，与主体支架的内壁相接触。该密封件与主体支架的内壁，在分支支架的远端腔口所在平面共同合围起密封区域。其中，该密封区域包括以分支支架为对称中心且包含分支支架的远端腔口的区域。从而，该密封件将分支支架的远端腔口进行密封，并将分支支架与主体支架的内壁间的远端空隙进行密封，从而实现覆膜支架血流通道外的远端空隙的密封。
该实施例的优点在于，密封件将覆膜支架血流通道外的远端空隙进行密封，避免了血液内漏的发生。
在一实施例中，密封区域还包括以分支支架为对称中心且包含分支支架的近端腔口的区域。
该实施例中，密封件与主体支架的内壁，还在分支支架的近端腔口所在平面共同合围起密封区域。其中，该密封区域包括以分支支架为对称中心且包含分支支架的近端腔口的区域。从而，该密封件将分支支架的近端腔口进行密封，并将分支支架与主体支架的内壁间的近端空隙进行密封，从而实现覆膜支架血流通道外的近端空隙的密封。
该实施例的优点在于，密封件将覆膜支架血流通道外的远端空隙进行密封的同时，将覆膜支架血流通道外的近端空隙也进行密封。通过双层的密封，进一步避免了血液内漏的发生。
在一实施例中，密封件包括对称位于分支支架两侧、贴附于主体支架的内壁、且为侧面设有覆膜的三棱柱结构的第一密封件与第二密封件，其中，从第一密封件的远端腔口至分支支架的远端腔口再至第二密封件的远端腔口设有覆膜。
该实施例中，密封件的数量为二，分别记为第一密封件以及第二密封件。第一密封件与第二密封件对称位于分支支架两侧，均贴附于主体支架的内壁，且均为侧面设有覆膜的三棱柱结构。从第一密封件的远端腔口至分支支架的远端腔口再至第二密封件的远端腔口设有覆膜，从而将覆膜支架血流通道外的远端空隙进行密封。
图5示出了根据本发明一实施例的覆膜支架的结构示意图。
参考图5所示。该实施例中，覆膜支架100除了包括主体支架110与分支支架120外，还包括两个三棱柱结构的密封件130。两个密封件130对称设于分支支架120两侧，贴附于主体支架110的内壁的同时，还贴附于所邻近的分支支架120。包含分支支架120的远端腔口所在区域的两个密封件130的远端腔口之间的区域设有覆膜，从而将覆膜支架100血流通道外的远端空隙进行密封。
图6示出了本发明一实施例的覆膜支架的俯视结构示意图。
参考图6所示。从远端向近端俯视，该覆膜支架中，分支支架的远端腔口30以及两侧的密封件130的远端腔口位于同一平面，并被位于远端的远端覆膜50密封。在远端覆膜50与主体支架110的内壁的合围下得到主体支架的远端腔口20，从而其他覆膜支架可通过套接在主体支架的远端腔口20的方式，与该覆膜支架相配合。
其中，分支支架的分支支撑架122通过缝合或热压的方式固定在分支覆膜121上。
在一实施例中，从第一密封件的远端腔口至分支支架的远端腔口再至第二密封件的远端腔口所设的覆膜呈月牙状。
该实施例中，密封件在远端的密封区域呈月牙状。
具体的，将三棱柱结构的三个侧面分别记为：贴附于主体支架内壁的第一侧面、平行于分支支架的第二侧面以及远离主体支架内壁的第三侧面。密封件在远端的密封区域呈月牙状，即：三棱柱结构的第三侧面为曲面。优选的，第一密封件的第三侧面与第二密封件的第三侧面均与分支支架相切，且相切线为分支支架通道表面距离主体支架的内壁的最远点所组成的直线。
该实施例的优点在于，三棱柱结构密封件中为曲面的第三侧面能够紧密贴附其他覆膜支架，避免分支支架与其他覆膜支架的空隙的产生，从而进一步避免血液内漏的发生。
图7示出了本发明一实施例的覆膜支架的远端横截面示意图。
参考图7所示。该实施例中，覆膜支架100的远端横截面由外围主体支架的远端横截面、内部密封件的远端横截面以及内部分支支架的远端横截面组成。
其中，密封件的远端横截面呈尖齿状，分支支架的远端横截面呈圆状。对称分布的密封件的远端横截面与位于对称中心的分支支架的远端横截面共同组成的区域呈月牙状。
主体支架的远端横截面中除去该月牙状的区域即为该主体支架的远端腔口。该覆膜支架与其他覆膜支架在该主体支架的远端腔口进行配合。由于密封件的远端横截面呈尖齿状，即：密封件远离主体支架内壁的第三侧面为曲面。该第三侧面可紧密贴附其他覆膜支架，避免分支支架与其他覆膜支架的空隙的产生，从而进一步避免血液内漏的发生。
且该实施例中，分支支架内切与该月牙状区域，在保证密封效果的同时，使得分支支架的腔口能够与其他覆膜支架直接接触，保证了分支支架所提供支撑的稳定性。
在一实施例中，密封件贴附于主体支架的侧面所设覆膜包括主体支架的覆膜。
该实施例中，密封件为三棱柱结构，其贴附于主体支架的侧面所设覆膜包括主体支架的覆膜。将贴附于主体支架的侧面记为第一侧面，即：第一密封件的第一侧面与主体支架共用覆膜；第二密封件的第一侧面与主体支架共用覆膜。
该实施例的优点在于，密封件的第一侧面与主体支架共用覆膜节省了材料的使用。
在一实施例中，密封件贴附于主体支架的侧面所设覆膜还包括补充覆膜。
该实施例中，密封件为三棱柱结构，其第一侧面所设覆膜除了包括主体支架的覆膜外，还包括补充覆膜。即：第一密封件的第一侧面与主体支架共用覆膜，并还设有第二层的补充覆膜；第二密封件的第一侧面与主体支架共用覆膜，并还设有第二层的补充覆膜。
该实施例的优点在于，在密封件的第一侧面与主体支架共用覆膜的基础上进一步设置第二层的补充覆膜，提高了密封件的结构稳定性和密封效果。
在一实施例中，密封件平行于分支支架的侧面所设覆膜包括分支支架的覆膜。
该实施例中，密封件为三棱柱结构，其平行于分支支架的通道方向的侧面所设覆膜包括分支支架的覆膜。将平行于分支支架的侧面记为第二侧面，即：第一密封件的第二侧面与分支支架共用覆膜；第二密封件的第二侧面与分支支架共用覆膜。
该实施例的优点在于，密封件的第二侧面与主体支架共用覆膜节省了材料的使用。
在一实施例中，密封件平行于分支支架的侧面所设覆膜还包括补充覆膜。
该实施例中，密封件为三棱柱结构，其第二侧面所设覆膜处理包括分支支架的覆膜，还包括补充覆膜。即：第一密封件的第二侧面与主体支架共用覆膜，并还设有第二层的补充覆膜；第二密封件的第二侧面与主体支架共用覆膜，并还设有第二层的补充覆膜。
该实施例的优点在于，在密封件的第二侧面与主体支架共用覆膜的基础上进一步设置第二层的补充覆膜，提高了密封件的结构稳定性和密封效果。
图8示出了本发明一实施例的密封件的结构示意图。
参考图8所示。该实施例中，位于分支支架左侧的三棱柱结构的密封件130包括位于其远端腔口的上侧面131、贴附于分支支架的右侧面132、贴附于主体支架的外侧面133、远离主体支架的内壁的内侧面134以及位于其近端腔口的下侧面135。
其中，密封件的右侧面132可以与分支支架共用覆膜，还可以在此基础上进一步设置第二层的补充覆膜；同理，密封件的外侧面可以与主题之家共用覆膜，还可以在此基础上进一步设置第二层的补充覆膜。
在一实施例中，密封件由支撑结构以及覆膜组成。
该实施例中，密封件的三棱柱结构由软质的覆膜在支撑结构的支撑下合围组成。其中，支撑结构的质地相较于覆膜的质地硬度更大。
可选的，在其他实施例中，密封件可仅由软质的覆膜合围组成，从而有效降低鞘管直径，并保证了支架的整体柔顺性。
在一实施例中，密封件内部中空。
该实施例中，三棱柱结构的密封件内部中空。
该实施例的优点在于，密封件内部中空，降低了密封件的质量。
在一实施例中，密封件内部填充可膨胀性材料。
该实施例中，三棱柱结构的密封件内部填充可膨胀性材料，例如：水凝胶。
该实施例的优点在于，密封件在内部所填充的可膨胀性材料的支撑下，结构更加稳定。
图9示出了本发明一实施例的所提供的覆膜支架与其他覆膜支架配合的结构示意图。
参考图9所示。该实施例中，覆膜支架100在两个贴附于主体支架的内壁的分支支架的支撑下与其他覆膜支架800组合在一起。
其中，分支支架的远端腔口30以及两侧的密封件130的远端腔口被位于远端的远端覆膜50密封，从而分支支架与主体支架间的远端空隙被密封，避免了血液的内漏。
在远端覆膜50与主体支架110的内壁的合围下得到主体支架的远端腔口20。其他覆膜支架800通过套接在主体支架的远端腔口20的方式，与覆膜支架100相配合。由于密封件130远离主体支架的内壁的内侧面为曲面，因此密封件的内侧面可以与其他覆膜支架800紧密贴附，从而避免了分支支架与其他覆膜支架800间空隙的产生，进一步避免了血液的内漏。
本领域技术人员在考虑说明书及实践这里公开的发明后，将容易想到本发明的其它实施方案。本申请旨在涵盖本发明的任何变型、用途或者适应性变化，这些变型、用途或者适应性变化遵循本发明的一般性原理并包括本发明未公开的本技术领域中的公知常识或惯用技术手段。说明书和实施例仅被视为示例性的，本发明的真正范围和精神由所附的权利要求指出。

Claims (25)

  1. 一种覆膜支架，其特征在于，包括：
    主体支架，所述主体支架为侧面设有覆膜的管状通道结构，其近端呈圆台状；
    分支支架，所述分支支架为管状通道结构，其贴附于所述主体支架的内壁，其通道方向与所述主体支架的通道方向一致，且其腔口设于所述主体支架的通道。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架的近端的母线呈弧形。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架的远端呈圆柱状。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架的远端配合所述主体支架的近端呈圆台状。
  5. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架的近端的旋转轴与所述主体支架的近端的母线间的夹角范围为5°～30°。
  6. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架至少一侧的侧面呈弧形。
  7. 根据权利要求1所述的覆膜支架，其特征在于，所述主体支架包含至少两个环绕所述主体支架的通道轴向的波圈支撑架，各个波圈支撑架由至少两个V形的支架连接得到，在位于主体支架端口的波圈结构的支架中，至少有一个为突出所设覆膜的高波裸支架。
  8. 根据权利要求7所述的覆膜支架，其特征在于，在位于主体支架端口的波圈支撑架中，等间距地设有三个所述高波裸支架。
  9. 根据权利要求7所述的覆膜支架，其特征在于，所述高波裸支架向所述主体支架的通道内侧弯曲。
  10. 根据权利要求1所述的覆膜支架，其特征在于，所述分支支架的腔口倾斜于所述分支支架的通道方向，其中，所述分支支架的腔口靠近所述主体支架的内壁的一侧低于远离所述主体支架的内壁的一侧。
  11. 根据权利要求10所述的覆膜支架，其特征在于，所述分支支架的腔口内嵌圆环结构或椭圆环结构。
  12. 根据权利要求1所述的覆膜支架，其特征在于，所述分支支架的远端设有腔口支撑架，用于支撑所述分支支架的远端腔口。
  13. 根据权利要求1所述的覆膜支架，其特征在于，所述分支支架包括第一分支支架以及第二分支支架。
  14. 根据权利要求13所述的覆膜支架，其特征在于，所述第一分支支架与所述第二分支支架相切。
  15. 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：
    密封件，所述密封件设于所述主体支架的通道中，其与所述主体支架的内壁合围的密封区域包括以所述分支支架为对称中心且包含所述分支支架的远端腔口的区域。
  16. 根据权利要求15所述的覆膜支架，其特征在于，所述密封区域还包括以所述分支支架为对称中心且包含所述分支支架的近端腔口的区域。
  17. 根据权利要求15所述的覆膜支架，其特征在于，所述密封件包括对称位于所述分支支架两侧、贴附于所述主体支架的内壁、且为侧面设有覆膜的三棱柱结构的第一密封件与第二密封件，其中，从所述第一密封件的远端腔口至所述分支支架的远端腔口再至所述第二密封件的远端腔口设有覆膜。
  18. 根据权利要求17所述的覆膜支架，其特征在于，从所述第一密封件的远端腔口至所述分支支架的远端腔口再至所述第二密封件的远端腔口所设的覆膜呈月牙状。
  19. 根据权利要求17所述的覆膜支架，其特征在于，所述密封件贴附于所述主体支架的侧面所设覆膜包括所述主体支架的覆膜。
  20. 根据权利要求19所述的覆膜支架，其特征在于，所述密封件贴附于所述主体支架的侧面所设覆膜还包括补充覆膜。
  21. 根据权利要求17所述的覆膜支架，其特征在于，所述密封件平行于所述分支支架的侧面所设覆膜包括所述分支支架的覆膜。
  22. 根据权利要求21所述的覆膜支架，其特征在于，所述密封件平行于所述分支支架的侧面所设覆膜还包括补充覆膜。
  23. 根据权利要求15所述的覆膜支架，其特征在于，所述密封件由支撑结构以及覆膜组成。
  24. 根据权利要求15所述的覆膜支架，其特征在于，所述密封件内部中空。
  25. 根据权利要求15所述的覆膜支架，其特征在于，所述密封件内部填充可膨胀性材料。
PCT/CN2021/136965 2020-12-31 2021-12-10 覆膜支架 WO2022143097A1 (zh)

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