WO2023221712A1 - Covered stent - Google Patents

Covered stent Download PDF

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Publication number
WO2023221712A1
WO2023221712A1 PCT/CN2023/088841 CN2023088841W WO2023221712A1 WO 2023221712 A1 WO2023221712 A1 WO 2023221712A1 CN 2023088841 W CN2023088841 W CN 2023088841W WO 2023221712 A1 WO2023221712 A1 WO 2023221712A1
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WO
WIPO (PCT)
Prior art keywords
stent
main body
opening
height
section
Prior art date
Application number
PCT/CN2023/088841
Other languages
French (fr)
Chinese (zh)
Inventor
朱永锋
周敏
刘昭
李晓强
朱清
徐健伟
刘金宏
薛彦慧
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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.)
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Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Publication of WO2023221712A1 publication Critical patent/WO2023221712A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821Ostial stents

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a covered stent.
  • Vascular interventional therapy as a minimally invasive treatment method, improves the survival probability of patients with vascular diseases who cannot tolerate surgery.
  • the abdominal aorta supplies blood to many internal organs of the human body, and both the renal artery and the superior mesenteric artery originate from the abdominal aorta. Therefore, when performing endoluminal surgery, it is necessary to ensure that the abdominal aorta, both The blood flow of the three arteries, the renal artery and the superior mesenteric artery, is smooth to ensure the patient's life safety.
  • the purpose of the present invention is to provide a covered stent that can solve the problems of the risk of endoleak at the splicing point of the stent and/or the inability to ensure smooth blood flow in both renal arteries and/or superior mesenteric arteries for a long time.
  • the present invention provides a covered stent, which includes a main body, the main body including a covered section and two embedded branch structures, the covered section is provided with two windows, and two The fenestration is used to connect the main body part with the renal artery; each of the embedded branch structures is respectively arranged at one of the fenestrations and is connected to the fenestration, and both of the embedded branch structures are It is located in the inner cavity of the main body, and the orientation of the embedded branch structure is consistent with the opening orientation of the renal artery.
  • the embedded branch structure is provided in the inner cavity of the stent graft and is an axially penetrating tubular structure having a first opening and a second opening, and the embedded branch structure includes a first height-increasing opening.
  • the stent segment and the inline branch coating, the inline branch coating wraps the first variable height stent segment, and the inline branch coating at the first opening is fixed at the window opening.
  • the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and the first opening is connected to the corresponding window;
  • the second opening When the opening of the renal artery is toward the proximal end of the main body, the second opening is provided toward the proximal end of the main body; when the opening of the renal artery is toward the distal end of the main body, the second opening is disposed toward the distal end of the main body part; or, when the opening of the renal artery is oriented perpendicular to the axial direction of the main body part, the second opening is disposed horizontally.
  • the embedded branch structure is an axially penetrating tubular structure with a first opening and a second opening
  • the embedded branch structure includes a first heightening stent segment, an embedded branch covering and a first opening.
  • Positioning ring structure, the embedded branch coating wraps the first height-increasing bracket section, the embedded branch coating at the first opening and the first positioning ring structure are fixed at the window opening.
  • the first height-increasing bracket section includes at least two first short ribs and at least two first high ribs, and all the first short ribs are connected in sequence and then connected to all the first high ribs that are connected in sequence. Forming an annular wavy structure, wherein the edge height of the first short edge is smaller than the edge height of the first high edge;
  • the embedded branch structure is provided with the first short edge and one end of the first high edge as the second opening, and the embedded branch structure is provided with only one end of the first high edge as the second opening.
  • the coating area near the first opening without the first short rib support is an empty film section.
  • the direction of the second opening is determined by the embedded branch coating provided at the first opening.
  • the empty membrane segment is determined by splicing with the proximal side or distal side of the window.
  • a portion of the embedded branch coating located at the second opening and facing the main body part is connected to the main body part.
  • the axial length of the embedded branch structure is 2 mm to 18 mm.
  • the coated section includes a window, which is axially spaced apart from the two opening windows, and is used to connect and communicate the main body part with the superior mesenteric artery.
  • the film-coated section includes a main body bracket and a main body coating, and the main body coating covers all
  • the main body stent is formed such that the distal end of the main body stent forms a closed inner cavity along the axial direction.
  • the main body stent includes two second variable-height stent segments and at least one first equal-height stent segment.
  • the two second second stent segments are The variable height stent segments are symmetrically arranged at the proximal end of the main body stent along the radial direction of the main body stent, and all the first equal height stent segments are arranged at the distal end of the main body stent in sequence along the axial direction, and the window Located on the main body coating between the two second height-increasing bracket sections, the window is provided on the main body coating covering the first equal-height bracket section or the second height-changing bracket section.
  • the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected to all the second high ribs that are connected in sequence.
  • An annular wavy structure is formed, the edge height of the second short edge is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short edge of the two second heightening bracket sections. between the edges.
  • the first equal-height bracket section is formed by a plurality of equal-length prisms connected end to end to form an annular wavy structure; the window is located between two adjacent prisms, and the two windows are arranged along the perimeter. are located on the main body coating of the same first equal-height bracket segment, or the two windows are circumferentially located on the main body coating of different first equal-height bracket segments; or, two of the windows are located on the main body coating of different first equal-height bracket segments; The window is circumferentially located on the main body covering covering the second height-increasing bracket section.
  • the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and a first positioning ring structure is provided at both the first opening and the second opening of the embedded branch structure.
  • the window is provided with a second positioning ring structure, the first positioning ring structure at the first opening is located outside the main body coating, and the first positioning ring structure at the second opening is located at the main body On the inside of the coating, the second positioning ring structure is located on the outside of the main body coating.
  • the second positioning ring structure and the first positioning ring structure both include a supporting wire and a developing wire, the supporting wire is in an annular shape, the developing wire is wound around the supporting wire or the developing wire and The support wires are arranged in parallel.
  • the beam diameter structure is arranged on the main body bracket and the main body coating, and the beam diameter structure includes a beam diameter coil and a suture coil, and the beam diameter coil surrounds all the parts along the circumferential direction.
  • the second variable-height stent section and/or the first equal-height stent section, the suture coil is arranged at the apex of the distal end, the proximal end of the second variable-height stent section and/or the first equal-height stent section, or On the edge.
  • suture coils are arranged on the edges, and two of the stitches are arranged on each edge. Sewing coils, the distance between the two sewing coils and their corresponding nearest vertices is equal; or, one sewing coil is provided on each edge, and the sewing coil is located at the midpoint of the edge.
  • the main body part further includes a bare section, the distal end of the bare section is connected to the proximal end of the main body coating, and the bare section overlaps the proximal end portion of the main body stent in the axial direction.
  • the bare segment includes a stent ring and a barb structure located at the proximal end of the stent ring, the barb structure includes a barb and a barb handle, and the distal end of the barb handle is connected to the stent ring, The proximal end of the barb handle is connected to the proximal end of the barb, the distal end of the barb is everted away from the axis of the stent ring, and the clamp between the barb and the axis of the stent ring The angle is 10° ⁇ 70°.
  • the splicing part is spliced at the distal end of the main body part, the splicing part includes a first splicing part, the proximal end of the first splicing part is connected to the distal end of the main body part .
  • the splicing part further includes a second splicing part, the distal end of the first splicing part has an ipsilateral branch and a contralateral branch, and the proximal end of the second splicing part is connected to the ipsilateral branch and used for The ipsilateral iliac artery blood flow is established, and the contralateral branch is used to establish the contralateral iliac artery blood flow after splicing.
  • the present invention provides a stent graft, which is used to connect the main body part and the renal artery through two said windows; each of the embedded branch structures is connected to one of the said windows, and the two said windows are connected to each other.
  • the embedded branch structures are all located in the inner cavity of the main body, and the orientation of the embedded branch structures is consistent with the opening of the renal artery, so as to drain the blood flow out of the opening of the renal artery, It also follows the natural direction of blood flow, making it closer to the original blood vessel shape of the human body.
  • the long-term good patency rate also greatly avoids the internal leakage that may occur when the embedded branch structure is spliced with a ball-expanded covered stent or a self-expanding stent in vivo.
  • the embedded branch structure is provided with a first short edge and one end of the first high edge as the second opening, and the embedded branch structure is provided with only one end of the first high edge as the first opening;
  • An empty film section with an embedded branch coating at an opening is spliced with the proximal or distal side of the window to determine the direction of the second opening, even if there is a first high edge and an embedded branch coating.
  • the part of the membrane forms the large curved side of the embedded branch structure, so that only the empty membrane section provided with the embedded branch coating forms the embedded branch structure.
  • the small curved side is easy to splice, and the design of the first variable-height stent segment of the present invention can ensure good flexibility on the small curved side; the small curved side can be strengthened to anchor the ball-expanded covered stent or self-expanding stent used in conjunction with it. At the same time, the overall pressing size of the covered stent is reduced, thereby reducing the requirement for the diameter of the access blood vessel.
  • the splicing of the main body, the first splicing part and the second splicing part, as well as the window, the window opening and the embedded branch structure are all centrally arranged in the main part, so that the main part can be designed according to the needs, and the first splicing part and the second splicing part can be designed according to the needs.
  • the second splicing part can be mass-produced without special customization, which makes the preparation of the first splicing part and the second splicing part less difficult, allows for quick distribution and delivery, greatly shortening the waiting time for wearing, and the same side branch can directly reconstruct the same side of the iliac Arterial blood flow, compared with the ipsilateral iliac artery stent intracorporeal splicing on the market, eliminates type III endoleak there, and also reduces the economic cost and time cost of the operation.
  • the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected with all the second high ribs in sequence to form a ring. It has a wavy structure, the edge height of the second short rib is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short ribs of the two second heightening bracket sections. This structure can improve the flexibility of the proximal end of the stent graft.
  • the second short rib can avoid superior mesenteric artery fenestration.
  • the symmetrical distribution of the two second short ribs can provide sufficient space for fenestration (ie, superior mesenteric artery fenestration).
  • the avoidance space can also provide sufficient radial support for the coating that is flush with the superior mesenteric artery window in the horizontal direction, ensuring the tightness of the coating that is flush with the superior mesenteric artery window in the horizontal direction with the abdominal aorta. fit.
  • Figure 1 is a schematic structural diagram of a stent graft according to an embodiment of the present invention
  • Figure 2 is a schematic structural diagram of the main body of an embodiment of the present invention.
  • Figures 3a-3c are structural schematic diagrams of the embedded branch structure in different directions according to an embodiment of the present invention.
  • Figure 4 is a schematic diagram of the first variable-height stent segment wrapped with an embedded branch coating according to an embodiment of the present invention after circumferential expansion;
  • FIG. 5 is a schematic structural diagram of the splicing part according to an embodiment of the present invention.
  • distal and proximal refer to the relative orientation, relative position, relative position, relative position, and relative position of components or actions relative to each other from the perspective of a physician using the medical device. Position and direction.
  • distal usually refers to the end of the medical device that is close to the operator during normal operation
  • proximal usually refers to the end that is close to the operator during normal operation.
  • edge height refers to, for example, the length of the two adjacent vertices A and A' in the second heightening stent segment in Figure 2 in the axial direction of the stent graft.
  • lateral refers to the direction perpendicular to the axis of the main body, that is, the direction from left to right in Figure 1 .
  • Figure 1 is a schematic structural diagram of a stent graft in this embodiment. As shown in Figure 1, this embodiment provides a covered stent that can be used to treat abdominal aortic aneurysms whose starting position is below the superior mesenteric artery and the distance from the lower edge of the superior mesenteric artery is greater than 4 mm.
  • Figure 2 is a schematic structural diagram of the main body of this embodiment. As shown in Figures 1 and 2, the stent graft includes a main body part 1 and a splicing part 2. The proximal end of the splicing part 2 is connected to the distal end of the main body part 1. The main body part 1 is used to be arranged in the visceral area of the aorta.
  • the main body 1 includes a bare section 100 and a covered section.
  • the distal end of the bare section 100 is connected to the proximal end of the covered section.
  • the bare section 100 is used to anchor the proximal end of the covered stent.
  • the coating section includes a main body stent and a main body coating.
  • the main body coating covers the main body stent and causes the distal end of the main body stent to form a closed inner cavity along the axial direction.
  • the main body coating is wrapped on the main body bracket to form the coating section.
  • the covered section of the main body 1 can isolate the aneurysm from the blood flow and allow the blood flow to flow through the inside of the covered stent.
  • the coating section includes a first coating section 200 and a second coating section 300 arranged along the axial direction.
  • the main body coating of the proximal end of the first coating section 200 is connected to the distal end of the bare section 100
  • the main body coating at the distal end of the first coating section 200 is connected to the main body coating at the proximal end of the second coating section 300 .
  • the superior mesenteric artery window 3 is provided on the main body coating of the first covered segment 200, and the superior mesenteric artery window 3 is used to communicate with the superior mesenteric artery;
  • the main body covering of the second covered segment 300 is provided with a superior mesenteric artery window 3.
  • the stent graft in this embodiment can provide radial support force for anchoring the proximal end of the stent graft from the bare section 100 to the first covered section 200 .
  • the radial cross-sections of the bare section 100, the first coated section 200 and the second coated section 300 are annular, and the diameters of the bare section 100, the first coated section 200 and the second coated section 300 are the same. .
  • the bare section 100 is used to anchor the proximal end of the stent graft with the normal blood vessel, and is used to extend the anchoring area of the stent graft and to be released after reaching the bare section when the stent graft cooperates with the delivery device. Purpose. In order to ensure that the bare segment 100 fully adheres to normal blood vessels, the bare segment 100 needs to have sufficient radial support. The ways to achieve this include but are not limited to the bare segment being made of 316 stainless steel, cobalt-chromium alloy or nickel-titanium alloy. Pipe diameter cut.
  • the bare segment 100 has multiple barb structures, and the barb structures are used to anchor the proximal end of the stent graft.
  • the bare segment 100 includes a wavy stent ring 110.
  • the wavy stent ring 100 has good radial stretchability to facilitate the bare segment to be pressed and held, and can also provide anchoring support.
  • the diameter of the stent ring 100 is 18mm-38mm to adapt to the size of blood vessels.
  • the barb structure is disposed on the crest (vertex M) of the stent ring 110 near the proximal end of the bare segment 100 .
  • the barb structure includes a barb handle 120 and a barb 130.
  • the distal end of the barb handle 120 is connected to the vertex M of the stent ring 110 near the proximal end of the bare segment for supporting the barbs. 130.
  • the proximal end of the barb 130 is connected to the proximal end of the barb handle 120.
  • the barb 130 and the barb handle 120 are connected after being formed separately. For example, they are cut and formed separately and then connected by welding, or , the barb 130 and the barb handle 120 are an integral structure, for example, they can be cut and formed in one piece.
  • the distal end of the barb 130 is a free end, which is everted away from the axis of the stent ring 110 , and the angle between the barb 130 and the axis of the stent ring 110 is 10° to 70°.
  • the barb structure facilitates the barb protection before the stent graft is completely released from the transporter, so that the stent graft will not scratch the blood vessel when it is adjusted in the blood vessel cavity in a semi-constrained state.
  • the length of the barb 130 is 1 mm to 6 mm, and the distal end of the barb 130 is tapered.
  • the above-mentioned shape cooperation of the bare section 100 can provide space for the introduction of other consumables in the semi-bound state of the stent graft.
  • the distal end of the bare section 100 is sutured to the main body covering of the proximal end of the first covered section 200 , and the bare section 100 is axially connected to the proximal part of the main body stent.
  • Overlap that is, the distal end of the bare segment 100 and the proximal end of the first covered segment 200 have an overlapping area along the axial direction of the main body stent, and the distal end of the bare segment 100 is close to the first covered segment 200 .
  • the distance from the vertex M' of the proximal end of the membrane segment 200 to the proximal edge of the main body membrane is located in the overlapping area, and the bare segment 100 is close to the distance from the apex M' of the proximal end of the first membrane segment 200. is 2 mm to 4 mm.
  • the bare segment 100 and the second higher height stent segment at the proximal end of the first covered segment 200 have an overlapping area in the axial direction of the main stent (for example, from the proximal edge of the first covered segment At a distance of 2 mm, the distance between the bare section 100 and the first coated section is
  • the second higher stent segment at the end overlaps in the axial direction of the main stent), which can increase the radial support point of the stent graft, making the proximal end of the stent graft better rounded, thereby effectively preventing the stent graft from being Type Ia endoleak occurs when the proximal end does not fit closely with the inner wall of the blood vessel.
  • the first film-coated section 200 includes two second variable-height bracket sections.
  • the first film-coated section 200 includes two second variable-height bracket sections 210 and 220.
  • the two second variable-height bracket sections 210 and 220 are symmetrically arranged at the proximal end of the main body stent (that is, the two second variable height stent sections 210 and 220 are symmetrical along the radial direction of the main body stent and are arranged at the proximal end of the main body stent).
  • the two second variable-height bracket sections 210 and 220 are spaced apart along the axial direction of the main body bracket, and the minimum axial distance between the two second variable-height bracket sections 210 and 220 is 1 mm to 6 mm.
  • the axial spacing between the two second variable height stent segments 210, 220 can be adjusted according to the degree of blood vessel curvature, so as to adjust the compliance of the second variable height stent segment near the superior mesenteric artery window, and finally fully adapt to the situation. Match the direction of blood vessels.
  • the axial distance between the two second variable height stent segments can be increased; conversely, the axial distance between the two second variable height stent segments can be reduced. direction spacing.
  • the second increased height stent section 210 can make the proximal end of the stent graft fit more closely with the normal blood vessel wall, thereby effectively preventing type Ia caused by the loose fit of the proximal end of the stent graft with the normal blood vessel wall. Internal leakage.
  • the second increased-height stent segment 210 and the bare segment 100 serve as anchoring areas for the proximal end of the stent graft, and both of them can provide radial areas for anchoring the proximal end of the stent graft. supporting force, and jointly ensure the full adhesion between the proximal end of the covered stent and the normal blood vessel.
  • the second height-changing bracket sections 210 and 220 are two identical brackets.
  • the second height-changing bracket section 210 includes a second short edge 211 and a second high edge 212.
  • the tall bracket section 220 includes a second short rib 221 and a second high rib 222, wherein the number of the second short ribs 211 and 221 is two, the number of the second tall ribs 212 and 222 is multiple, and all the second short ribs 211 and 222 are in number.
  • the ribs 211 are connected in sequence and then connected to all the second high ribs 212 in sequence to form an annular wavy second height-increasing bracket section 210.
  • All the second short ribs 221 are connected in sequence and connected in sequence to all the second short ribs 212 in sequence.
  • the second high edges 222 are then connected to form an annular wavy second height-increasing bracket section 220 .
  • the edge height of the second short ribs 211 and 221 is smaller than the edge height of the second high ribs 212 and 222, and the edge height of the second short ribs 211 and 221 is 2 mm to 8 mm.
  • the second high rib The edge height of 212 and 222 is 8mm ⁇ 16mm.
  • the second height-changing bracket sections 210 and 220 are arranged laterally symmetrically, the apex A formed at the distal end of the second height-changing bracket section 210 after the two second short edges of the second height-changing bracket section 210 are connected and the two second height-changing bracket sections 220 are connected.
  • the apex A' formed at the proximal end of the second short rib after being connected is arranged directly opposite to the apex formed at the distal end of any two second high edges of the second height-increasing stent section 210 after being connected with the second height-increasing stent.
  • the vertices formed by the proximal ends of the two second high edges of the segment 220 are facing each other, which causes the distance between the vertex A and the vertex A' to be the distal vertex of the second height-increasing stent segment 210 and its
  • the opposite second heightening stent section 220 has the greatest distance at its proximal apex.
  • the design of the second short ribs 211 and 221 is mainly used to avoid the superior mesenteric artery window 3, and can also be used to wrap the second short ribs 211 and 221 in the radial direction.
  • the coating of the increased-height stent segments 210 and 220 provides sufficient radial support force to ensure that the coating around the superior mesenteric artery window 3 adheres closely to the abdominal aorta. According to the size of the blood vessel, the distance between the vertices A and A' and the superior mesenteric artery window 3 is less than 3 mm.
  • the superior mesenteric artery window 3 is used to reshape the blood flow of the superior mesenteric artery smoothly.
  • the superior mesenteric artery window 3 includes a window (such as a circular window) cut out on the main body covering between the vertices A and A' and a second positioning ring structure disposed at the window.
  • the The second positioning ring structure is a circular structure, and the second positioning ring structure is sewn on the main body covering outside the window.
  • the size of the superior mesenteric artery window 3 is the size of the second positioning ring structure.
  • the inner diameter is sized such that the superior mesenteric artery window 3 is aligned with the opening of the superior mesenteric artery.
  • the second positioning ring structure is composed of a supporting wire and a developing wire. Furthermore, the supporting wire and the developing wire are arranged in parallel (independent of each other and not entangled) or the supporting wire and the developing wire are entangled with each other.
  • the second positioning ring structure The composition not only ensures the stiffness requirements of the superior mesenteric artery window opening, but also ensures position tracking under rays, thereby increasing the visibility of the covered stent and facilitating surgical operations.
  • the material of the supporting wire is 316 stainless steel, cobalt-chromium alloy or nickel-titanium alloy, etc., and the material of the developing wire is gold with good developability, etc.
  • the support wire and the development wire are in the shape of a ring, and the diameters of the rings formed by the support wire and the development wire are the same.
  • the developing wire is wound around the body of the supporting wire (for example, spirally wound), thereby forming the annular second positioning ring structure.
  • the inner diameter of the second positioning ring structure is 6 mm to 14 mm to match the opening diameter of the superior mesenteric artery.
  • the mesenteric upward movement A ball-expanded covered stent or a self-expanding stent can be placed in the pulse window 3 to reconstruct the superior mesenteric artery blood flow.
  • the second covered section 300 is used to support the blood vessel wall to improve the adhesion of the covered stent.
  • the second coating section 300 includes at least one first equal-height bracket section 310.
  • the first equal-height bracket section is formed by a plurality of equal-length prisms 311 connected end to end to form an annular wave-shaped bracket section.
  • the first equal-height bracket section 310 can effectively reserve space for the embedded branch structure 4 .
  • the second variable-height bracket sections 210 and 220 and at least one first equal-height bracket section 310 are sequentially spaced along the axial direction of the covered stent and are fixedly connected through the main body coating.
  • the edge height of the prism 311 is 6 mm to 12 mm.
  • the distance between the second variable-height bracket section 220 and its adjacent first equal-height bracket section 310 is 1 mm to 5 mm.
  • the spacing between adjacent first equal-height bracket segments 310 is 1 mm to 5 mm, and at least two first equal-height bracket segments 310 can be uniform along the axial direction.
  • the distribution may also be non-uniformly distributed along the axial direction to achieve the purpose of avoiding the opening of the embedded branch structure 4 .
  • the main body part also includes two inline branch structures 4.
  • the inline branch structures 4 are provided on the main body coating of the second coating section 300, so that the interior of the stent graft passes through the two inline branches.
  • Structure 4 is connected to two renal arteries respectively.
  • the two opening windows may also be provided on the main body covering covering the second height-increasing bracket section, and the two opening windows are circumferentially located on the main body covering the second height-increasing bracket segment.
  • the main body of the segment is covered with film.
  • Each fenestration is aligned with the opening of a renal artery, and each fenestration is used to connect an embedded branch structure 4 .
  • a ball-expanding covered stent or a self-expanding stent can be placed within the embedded branch structure to reconstruct renal artery blood flow.
  • the embedded branch structure 4 includes a first variable-height bracket section, an embedded branch coating 420 and two first positioning ring structures.
  • the embedded branch coating 420 wraps the first variable-height bracket section to form
  • the axially penetrating tubular structure, that is, the embedded branch structure 4 is a tubular structure with openings at both ends.
  • the openings at both ends are respectively the first opening 400a and the second opening 400b.
  • the first positioning ring structure is fixed at both the first opening 400a and the second opening 400b of the tubular structure.
  • the first positioning ring structure connected to the first opening 400a is first placed on the main body coating. on the outer surface, and then connect the inner Embedded branch structure 4.
  • the embedded branch structure 4 is provided in the inner cavity of the stent graft, and the embedded branch structure 4 and the first positioning ring structure at the first opening are fixed at the window, and the The first positioning ring structure at the first opening is located on the outside of the main body coating.
  • the second opening 400b is a free end without a connecting structure.
  • the first positioning ring structure at the second opening is located on the outside of the main body coating. inside.
  • the first positioning ring structure and the second positioning ring structure are made of the same material and shape respectively, and the inner diameter of the first positioning ring structure is 3 mm to 9 mm to match the diameter of the human renal artery.
  • FIGS 3a-3c are schematic structural diagrams of the embedded branch structure in different directions in this embodiment.
  • the orientation of the embedded branch structure 4 is designed according to the direction of the blood vessels. Specifically, the orientation of the embedded branch structure 4 (that is, the orientation of the second opening of the embedded branch structure 4) is consistent with the direction of the kidney.
  • the openings of the arteries are oriented in the same direction.
  • the second opening of the embedded branch structure 4 can be directed towards the proximal end (i.e.
  • the renal artery runs essentially horizontally near the abdominal aorta (that is, the opening of the renal artery is oriented perpendicular to the axis of the main body), sewing can be performed horizontally to reduce bulbar expansion.
  • the flexibility of the membrane stent or the self-expanding stent requires that the second opening be set horizontally, that is, the connection line between the second opening of the embedded branch structure 4 and the opening of the renal artery is perpendicular to the axial direction of the main body.
  • the sewing methods of the embedded branch structures 4 can be upward sewing, downward sewing, and horizontal sewing.
  • the two embedded branch structures 4 can be combined according to the direction of the patient's blood vessels to form a double upward, downward sewing, or horizontal sewing. Combinations such as double downward, double horizontal, one upward and one downward, one horizontal and one upward, or one horizontal and one downward.
  • the orientation of the two embedded branch structures 4 can be controlled by the second opening suture, or can be Through the size control of the empty membrane segment.
  • FIG. 4 is a schematic diagram of the first variable-height stent segment wrapped with an embedded branch coating in this embodiment after circumferential expansion.
  • the first height-increasing bracket section 410 includes a first short edge 411 and a first high edge 412. All the first short edges and the first high edges are connected end to end in sequence and then connected to form a ring shape.
  • a wavy bracket segment, and the lines connecting all vertices on at least one end of the bracket segment are on the same straight line.
  • the number of the first short ribs 411 is 4-8
  • the number of the first high ribs 412 is 4-8
  • all the first short ribs 411 are connected with all the first high ribs 412 in sequence. connection.
  • the edge height of the first short edge 411 is smaller than the edge height of the first high edge 412, and the edge height of the first short edge 411 is 2 mm to 10 mm, and the edge height of the first high edge 412 is 3mm ⁇ 16mm.
  • the connecting lines of all the vertices on one end of the first height-increasing bracket section 410 are on the same straight line, that is, all the vertices of one end of the embedded branch structure 4 are provided with the first short edge and the first high edge. If they are on the same straight line, then this end is the second opening, and the other end (that is, the end where all the vertex lines are not on the same straight line, that is, the end where all the vertex lines are curves or polylines) is the embedded branch.
  • the structure is provided with only one end of the first high edge as the first opening.
  • the coating area in the embedded branch structure 4 near the first opening that is not supported by the first short rib 411 is an empty film section 415.
  • the first opening 400a of the embedded branch structure 4 when the first opening 400a of the embedded branch structure 4 is spliced with the window opening, it can be determined by adjusting the empty membrane section 415 above the first opening 400a to be spliced with the proximal side or the distal side of the window. The direction of the second opening 400b.
  • the principle is: by retracting the distance between the second opening 400b and the corresponding side of the empty film section between the empty film section 415 and the proximal side or the distal side of the window during sewing, a small curved side close to the main body film is formed. 414, and a large curved side 413 opposite the small curved side 414.
  • the large curved side 413 is located in the area where all the first high edges 412 in the first height-increasing bracket section 410 are connected, and the small curved side 414 is located in the empty membrane section 415 .
  • the small curved side 414 has a greater degree of curvature than the curved side 413 , which requires high flexibility of the embedded branch structure 4 . Therefore, in this embodiment, the empty film section 415 is used to form the small curved side 414 .
  • the embedded branch structure 4 is sewn to the main body film, and the embedded branch structure 4 is sewn upward or downward, the third part of the embedded branch structure 4
  • An opening 400a is sewn at the opening of the film of the second film section.
  • the second opening 400b of the embedded branch structure 4 can be a free end, or it can be covered by covering the embedded branch close to the second opening 400b.
  • the part of the film 420 facing the main body coating is sewn on the main body coating of the second coating section to fix the second opening 400b of the embedded branch structure 4 on the coating of the second coating section.
  • the embedded branch structure 4 is sewn on the main body coating of the second coating section.
  • the orientation of the second opening 400b is determined by the portion of the first opening 400a where the branch film is embedded (i.e., the empty film section 415) and the portion near the window. End-side or distal-side splicing to determine. Specifically, during sewing, the first opening 400a is sewn at the window opening of the film of the second film section. As shown in Figures 3a and 4, taking the second opening of the embedded branch structure 4 being sewn downward as an example, the first opening 400a of the embedded branch structure 4 corresponds to the window, and the empty film section 415 is located on the far end side of the window.
  • the embedded branch structure 4 420 adopts the sewing method of the first height-increasing bracket segment as shown in Figure 4, that is: according to the direction requirements, at the first opening 400a, the area provided with the first high edge 412 corresponds to the far end side of the window, and only The empty film section 415 with the embedded branch coating 420 corresponds to the distal side of the window, and the first positioning ring structure is placed on the outer surface of the coating at the window; the embedded branch coating of the embedded branch structure 4 420 extends from the window opening to the outer surface of the second coating section, and covers the first positioning ring structure.
  • the embedded branch structure can be controlled by controlling the length of the empty film section 415 extending out of the window.
  • the tilt angle is 4, which can ensure good compliance of the small curved side 414, and can also reduce the overall pressing size of the stent graft, thereby reducing the requirements of the stent graft on the diameter of the access blood vessel.
  • the ball-expanded (expansion) size of the ball-expanded stent graft or self-expanding stent in the empty membrane section If it is larger, the ball-expanded stent graft or the self-expanding stent can be stuck between the first short edge 411 of the first height-increasing stent section and the first positioning ring structure.
  • the first opening of the embedded branch structure 4 is sewn to the coating of the second coating section.
  • the opening of the window that is to say, when the access point of the ball-expanded stent graft used is the distal end, the second opening 400b of the first heightening stent section 410 faces the distal end, reducing the pressing size of the stent graft. , for easy pressing and holding.
  • the ball-expanded stent graft when used with the ball-expanded stent graft, when the ball-expanded stent graft is expanded in the inner cavity of the embedded branch structure, the ball-expanded stent graft has a larger expansion space in the empty membrane segment, thereby reinforcing the anchoring ball-expanded stent graft. Membrane stent to prevent displacement.
  • the second opening 400b of the first heightening stent section faces the proximal end to achieve the same effect.
  • the embedded branch structure when the renal artery runs substantially horizontally near the abdominal aorta, may include a contoured stent segment, an embedded branch coating and a first positioning ring structure, the embedded branch coating wrapping
  • the equal height support section includes a plurality of equal height edges connected end to end.
  • the axial length of the embedded branch structure 4 is 2 mm to 18 mm, which can ensure the smooth blood flow of the renal artery and greatly avoid possible splicing when the main body 1 is spliced with the ball-expanding covered stent or self-expanding stent in vivo.
  • Endoleak i.e. type III endoleak
  • the splicing part 2 includes a first splicing part 600 located at the proximal end and a second splicing part 700 located at the distal end.
  • the first splicing part 600 is a tubular structure.
  • the first splicing part 600 It is an integrated bifurcated structure, and the distal end of the first splicing part 600 is divided into two tubular leg structures from the proximal end to the distal end, namely the ipsilateral branch 621 and the contralateral branch 622, wherein the ipsilateral branch
  • the axial length of 621 is longer, shorter, or the same as the axial length of the contralateral branch 622.
  • the proximal end of the first splicing part 600 is connected to the distal end of the main body part 1 , and the distal end of the same side branch 621 is connected to the proximal end of the second splicing part 700 .
  • the main body part 1 is located in the visceral area of the human aorta and is mainly used to provide sealing of the proximal end of the stent graft and to provide access for reconstruction of the visceral branches.
  • the first splicing part 600 is located in the aneurysm cavity and is mainly used to provide a closed blood flow channel in the abdominal aortic aneurysm cavity to isolate the abdominal aortic aneurysm cavity.
  • the second splicing part 700 is located at the distal end of the abdominal aortic aneurysm cavity and extends into the ipsilateral iliac artery of the patient.
  • the main body part 1, the first splicing part 600 and the second splicing part 700 are spliced together by suturing to form a whole stent graft.
  • the sutured one-piece stent eliminates type III endoleak, reduces the economic cost and time cost of the operation, and at the same time, this splicing structure can achieve rapid delivery. , allowing patients to reduce waiting time as much as possible.
  • the ipsilateral side is the side in the same direction as the entrance of the delivery system, and the contralateral side is the side opposite the ipsilateral side.
  • the first splicing part 600 includes a main body lower section 610, a bifurcation section 620 and a first splicing coating.
  • the main body lower section 610 is provided at the proximal end of the bifurcation section 620, and the first splicing coating covers the main body lower section. 610 and bifurcated section 620, the proximal end of the first splicing coating is connected to the distal end of the main body coating of the main body part 1.
  • the lower body section 610 includes at least one second equal-height bracket section 611 .
  • the shape, diameter, and material of the second equal-height bracket section are the same as those of the first equal-height bracket section 310 . .
  • the first splicing coating wraps at least one of the second equal-height bracket sections 611 .
  • the bifurcated section 620 includes a wavy elliptical ring stent section 623.
  • the radial cross section of the proximal end of the elliptical ring stent section 623 is circular, and the radial cross section of the distal end is oval, and the elliptical ring stent section 623
  • Both the major axis and the minor axis of the radial cross section of the stent segment 623 gradually decrease from the proximal end to the distal end, so as to make the bifurcation of the bifurcated segment 620 smooth.
  • the diameter, material and shape of the stent section of the ipsilateral branch 621 and the stent section of the contralateral branch 622 are all the same.
  • the stent section of the contralateral branch 622 adopts a constant height stent, so that the diameter of the contralateral branch 622 is
  • the diameter is fixed diameter design, which can better match the contralateral iliac artery branches.
  • the use of stent segments is used to establish contralateral iliac artery blood flow after splicing; the stent segment of the ipsilateral branch 621 also uses a constant height stent, so that the radial diameter of the ipsilateral branch 621 is a fixed diameter design, so that the second splicing
  • the parts 700 are connected with equal diameters, thereby facilitating mass production of the second splicing part 700 .
  • the proximal end of the second splicing part 700 is connected to the distal end of the same side branch 621. Furthermore, the proximal end of the coating of the second splicing part 700 is sewn to the third distal end of the same side branch 621. A splicing film is applied.
  • the second splicing part 700 includes a first equal diameter section 710, a transition section 720 and a second equal diameter section 730 that are connected in sequence along the axial direction. The proximal end of the first equal diameter section 710 is connected to the distal end of the same side branch 621.
  • the proximal end of the transition section 720 is connected to the distal end of the first equal diameter section 710, the distal end of the transition section 720 is connected to the proximal end of the second equal diameter section 730, the bracket section of the first equal diameter section 710 and
  • the stent sections of the second equal-diameter section 730 are all equal-height stents and have a wavy annular structure.
  • the diameter of the stent section of the first equal-diameter section 710 is the same as the diameter of the stent section of the branch on the same side, and the second equal-diameter section
  • the diameter of 730 is larger than the diameter of the first equal-diameter section 710, and the stent section of the transition section 720 is a variable-diameter stent, so that the diameter of the transition section 720 gradually increases from the proximal end to the distal end.
  • the diameter of the second equal diameter section 730 is equal to the diameter of the distal end of the transition section 720. Specifically, the diameter of the second equal diameter section 730 is 6 mm to 28 mm, and the length is 20 mm to 180 mm.
  • the second equal diameter section 730 is used to fit the second splicing portion 700 to the wall of the diseased blood vessel, and is also used to seal the distal end of the second equal diameter section 730 .
  • the sum of the lengths of the ipsilateral branch 621 , the first equal diameter section 710 , the transition section 720 and the second equal diameter section 730 is greater than the opposite side branch 622 .
  • the proximal end of the main body coating is provided with two developing points to realize the position calibration of the proximal end of the stent graft under rays.
  • the developing points are respectively an O-shaped developing point 142 and an 8-shaped developing point 141.
  • the O-shaped developing points 142 and 8-shaped developing points 141 are evenly distributed along the proximal circumferential direction of the main body coating.
  • an 8-shaped developing point 141 and three O-shaped developing points 142 are provided at the proximal end of the main body coating, and the spacing between each developing point is the same (the angle between each developing point is 90°), and the 8-shaped developing point 141 is arranged on the same side or the opposite side of the stent graft, and the three O-shaped developing points 142 are arranged in the other three directions.
  • the stent graft also includes a beam diameter structure 500, which is provided on the main body stent and the main body coating.
  • the beam diameter structure 500 includes a plurality of beam diameter coils 510 and a plurality of suture coils 520.
  • the beam diameter coils 510 are made of PTFE, PET or ultra-high resolution. Made of soft polymer materials with good biocompatibility such as polyethylene.
  • the beam diameter coil 510 circumferentially surrounds the second variable-height bracket segment and/or the first equal-height bracket segment, that is, each bracket segment (for example, the second variable-height bracket segment, the first equal-height bracket segment, the third At least one of a variable-height bracket section, a second equal-height bracket section, a bracket section of the lower body section, etc.) has at least two beam diameter coils 510 .
  • each stent segment has two beam diameter coils 510.
  • the two beam diameter coils 510 can overlap or be arranged at intervals along the axial direction of the covered stent, and the beam diameter coils 510 can be set in the edge or at any position at the vertex of the bracket segment, and can be set according to actual needs.
  • One end of the two beam diameter coils 510 can start from the same point or different points in opposite directions, and "hug" the bracket segment in the circumferential direction. After the two beam diameter coils 510 "hug" the bracket segment in the circumferential direction, the main body guide The wire passes through the other ends of the two beam diameter coils to constrain the stent segments in the radial direction to achieve the beam beam effect.
  • the two beam diameter coils 510 are arranged at intervals and are respectively arranged at the vertices of the proximal end and/or the distal end of each stent segment.
  • the suture coil 520 is a hollow coil sewn on the main body coating of the main body part and the first splicing coating of the second equal-height stent section, and its diameter is 0.5 mm to 2 mm.
  • the suture coil 520 is disposed at the vertex of the distal end of each stent segment (i.e., vertex A), the vertex of the proximal end (ie, vertex A'), or on the edge.
  • the suture coils 520 are disposed on the edges of each stent segment, two suture coils 520 can be disposed on each edge, and the two suture coils are equally spaced from their corresponding nearest vertices; one suture coil can also be disposed on each edge.
  • the suture coil 520 is located at the midpoint of the edge, that is, the distance between it and the vertices on both sides is equal, or is located at the vertex of the distal end of the second variable-height stent segment and/or the first equal-height stent segment. , on the proximal vertex.
  • the A vertex is the trough of each stent segment, and the A’ vertex is the crest of each stent segment.
  • the beam diameter coil 510 is inserted into the suture coil, and passes through the suture coil at the overlapping positions of all suture coils and stent segments before surrounding the stent segment, so that the suture coil 520 is at the A vertex, A' Each bracket segment is fixed to the covering film wrapping it at the vertex or edge.
  • the structure is simple and easy to operate and has a reliable effect. Adopting this structure can effectively avoid the stent segment being unable to spring out due to the wire nodes being stuck during release.
  • the beam diameter coil 510 is restricted after passing through the suture coil 520 and can only move in the circumferential direction to ensure the stability of the beam diameter. By adjusting the length of the beam diameter coil, the ratio of the beam diameter can be adjusted from 40% to 90% of the nominal diameter.
  • the beam diameter coil 510 and the suture coil 520 need to be avoided when encountering the openings and windows. That is, the beam diameter coil 510 cannot block the opening of the superior mesenteric artery window 3 and the embedded branch structure on the main body coating. Therefore, the second positioning ring structure of the superior mesenteric artery window 3 and the second positioning ring structure of the embedded branch structure 4 On a certain positioning ring structure, the suture coil 520 fixes the beam diameter coil 510 on the outside of the superior mesenteric artery window 3 and the embedded branch structure 4.
  • the number of suture coils on the superior mesenteric artery window 3 and the embedded branch structure can be 1 to 4 respectively.
  • the material of the bracket and the second splicing part 700 are all nickel-titanium, cobalt-chromium alloy or 316 stainless steel, and the shape is annular and wavy.
  • the main body coating, embedded branch coating, main body lower section coating, bifurcation section coating and second splicing section 700 coating are all made of polymer soft materials with good biocompatibility, which can make the stent
  • the segments form a closed inner cavity in the axial direction.
  • the present invention provides a stent graft, which is used to connect and communicate the main body part with the renal artery through two of the fenestrations; and each of the embedded branch structures is connected to one of the fenestrations. connected, the two embedded branch structures are located in the inner cavity of the main body, and the orientation of the embedded branch structures is consistent with the opening of the renal artery, so as to control the blood flow out of the opening of the renal artery. It plays a drainage role and follows the natural direction of blood flow, making it closer to the original blood vessel shape of the human body.
  • first height-increasing stent segment and the embedded branch coating located in the first high-edge connection area serve as the large curved side of the embedded branch structure, and there are no
  • the embedded branch coating supported by the first short rib serves as the small curved side of the embedded branch structure, and the small curved side is located at the first opening, so that the first short rib avoids the First to speak.
  • the design of the first variable-height stent section of the present invention can ensure good compliance of the small curved side; the small curved side can strengthen the anchorage of the ball-expanded stent graft or self-expanding stent used, and at the same time reduce the overall pressure of the stent graft. size, thereby reducing the requirements for the diameter of the access vessel.
  • the splicing of the main body part, the first splicing part and the second splicing part, as well as the window and window opening and embedded branch structures are centrally arranged in the main body, so that the main body can be designed according to needs, and the first splicing part and the second splicing part can be mass-produced without special customization, making the preparation of the first splicing part and the second splicing part difficult. It can be quickly distributed and delivered, which greatly shortens the waiting time for wearing.
  • the ipsilateral branch can directly reconstruct the ipsilateral iliac artery blood flow. Compared with the ipsilateral iliac artery stent in vivo splicing on the market, this problem is eliminated. Type III endoleak also reduces the economic cost and time cost of surgery.
  • the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected with all the second high ribs in sequence to form a ring. It has a wavy structure, the edge height of the second short rib is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short ribs of the two second heightening bracket sections. This structure can improve the flexibility of the proximal end of the stent graft.
  • the second short rib can avoid superior mesenteric artery fenestration.
  • the symmetrical distribution of the two second short ribs can provide sufficient space for fenestration (ie, superior mesenteric artery fenestration).
  • the avoidance space can also provide sufficient radial support for the coating that is flush with the superior mesenteric artery window in the horizontal direction, ensuring the tightness of the coating that is flush with the superior mesenteric artery window in the horizontal direction with the abdominal aorta. fit.

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Abstract

The present invention provides a covered stent. Two fenestrations are used for enabling a main body part to communicate with a renal artery. Each embedded branch structure is connected to one of the fenestrations. The two embedded branch structures are located in an inner cavity of the main body part. The embedded branch structures are oriented in the same direction as an opening of the renal artery, so as to drain blood flowing out of the opening of the renal artery, and follow the natural course of the blood flow to be in a shape similar to that of an original blood vessel of a human body. Moreover, the embedded branch structures also reduce the flexibility requirement on the ball-expansion covered stent or self-expansion stent for use in cooperation, ensuring the long-term patency rate of the ball-expansion covered stent or self-expansion stent, and greatly avoiding the possible splicing internal leakage when the embedded branch structures are spliced with the ball-expansion covered stent or self-expansion stent.

Description

一种覆膜支架A covered stent 技术领域Technical field
本发明涉及医疗器械技术领域,特别是涉及一种覆膜支架。The present invention relates to the technical field of medical devices, and in particular to a covered stent.
背景技术Background technique
血管介入治疗作为一种微创的治疗方式,为不能耐受外科手术的血管疾病患者提升了生存概率。人体血管分叉众多,一些动脉瘤的病变区域会累及到分支血管区域。以腹主动脉结构为例,腹主动脉为人体诸多内脏供血,而双肾动脉和肠系膜上动脉均发自于腹主动脉,因此,在进行腔内手术治疗时,需确保腹主动脉、双肾动脉和肠系膜上动脉这3根动脉的血流通畅,以保障患者的生命安全。Vascular interventional therapy, as a minimally invasive treatment method, improves the survival probability of patients with vascular diseases who cannot tolerate surgery. There are many branches of blood vessels in the human body, and the lesion area of some aneurysms will involve the branch blood vessel areas. Take the structure of the abdominal aorta as an example. The abdominal aorta supplies blood to many internal organs of the human body, and both the renal artery and the superior mesenteric artery originate from the abdominal aorta. Therefore, when performing endoluminal surgery, it is necessary to ensure that the abdominal aorta, both The blood flow of the three arteries, the renal artery and the superior mesenteric artery, is smooth to ensure the patient's life safety.
当患者的腹主动脉瘤的起始位置在肠系膜上动脉下方且与肠系膜上动脉下缘距离大于4mm时,现有的标准血管支架无法同时保证支架不发生移位和双肾动脉及肠系膜上动脉的血流通畅,然而这两点对于患者来说是致命的。而传统的开腹手术治疗具有创伤大、风险高的缺点,尤其不适合年龄较大的患者。而国外市场上存在的极少的覆膜支架虽然可治疗此类动脉瘤,但这些覆膜支架的结构设计和方案均有一定的局限性。其具有术式复杂,售价昂贵,支架拼接处存在内漏风险和无法长期保证双肾动脉及肠系膜上动脉的血流通畅等缺点。When the starting position of the patient's abdominal aortic aneurysm is below the superior mesenteric artery and the distance from the lower edge of the superior mesenteric artery is greater than 4 mm, the existing standard vascular stent cannot ensure that the stent does not shift and both the renal artery and the superior mesenteric artery are not displaced at the same time. The blood flow is smooth, but these two points are fatal to the patient. However, traditional laparotomy treatment has the disadvantages of large trauma and high risk, and is especially not suitable for older patients. Although there are very few covered stents on the foreign market that can treat such aneurysms, the structural designs and solutions of these covered stents have certain limitations. It has the disadvantages of complex surgical procedures, high price, risk of endoleak at the stent splicing point, and inability to ensure smooth blood flow in both renal arteries and superior mesenteric arteries for a long time.
发明内容Contents of the invention
本发明的目的在于,提供一种覆膜支架,可以解决支架拼接处存在内漏风险和/或无法长期保证双肾动脉和/或肠系膜上动脉的血流通畅的问题。The purpose of the present invention is to provide a covered stent that can solve the problems of the risk of endoleak at the splicing point of the stent and/or the inability to ensure smooth blood flow in both renal arteries and/or superior mesenteric arteries for a long time.
为了解决上述问题,本发明提供一种覆膜支架,包括主体部,所述主体部包括覆膜段和两个内嵌分支结构,所述覆膜段设置有两个开窗,两个所述开窗用于使所述主体部与肾动脉对接相通;每个所述内嵌分支结构分别设置在一个所述开窗处,并与所述开窗相连,两个所述内嵌分支结构均位于所述主体部的内腔中,且所述内嵌分支结构的朝向与肾动脉的开口朝向一致。 In order to solve the above problems, the present invention provides a covered stent, which includes a main body, the main body including a covered section and two embedded branch structures, the covered section is provided with two windows, and two The fenestration is used to connect the main body part with the renal artery; each of the embedded branch structures is respectively arranged at one of the fenestrations and is connected to the fenestration, and both of the embedded branch structures are It is located in the inner cavity of the main body, and the orientation of the embedded branch structure is consistent with the opening orientation of the renal artery.
可选的,所述内嵌分支结构设置在所述覆膜支架的内腔且为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构包括第一变高支架段和内嵌分支覆膜,所述内嵌分支覆膜包裹所述第一变高支架段,所述第一开口处的内嵌分支覆膜固定在所述开窗处。Optionally, the embedded branch structure is provided in the inner cavity of the stent graft and is an axially penetrating tubular structure having a first opening and a second opening, and the embedded branch structure includes a first height-increasing opening. The stent segment and the inline branch coating, the inline branch coating wraps the first variable height stent segment, and the inline branch coating at the first opening is fixed at the window opening.
可选的,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述第一开口与对应的所述开窗相连;Optionally, the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and the first opening is connected to the corresponding window;
所述肾动脉的开口朝向所述主体部近端时,所述第二开口朝向所述主体部的近端设置;所述肾动脉的开口朝向所述主体部远端时,所述第二开口朝向所述主体部的远端设置;或者,所述肾动脉的开口朝向与所述主体部的轴向垂直时,所述第二开口水平设置。When the opening of the renal artery is toward the proximal end of the main body, the second opening is provided toward the proximal end of the main body; when the opening of the renal artery is toward the distal end of the main body, the second opening is disposed toward the distal end of the main body part; or, when the opening of the renal artery is oriented perpendicular to the axial direction of the main body part, the second opening is disposed horizontally.
可选的,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构包括第一变高支架段、内嵌分支覆膜和第一定位环结构,所述内嵌分支覆膜包裹所述第一变高支架段,所述第一开口处的内嵌分支覆膜和所述第一定位环结构固定在所述开窗处。Optionally, the embedded branch structure is an axially penetrating tubular structure with a first opening and a second opening, and the embedded branch structure includes a first heightening stent segment, an embedded branch covering and a first opening. Positioning ring structure, the embedded branch coating wraps the first height-increasing bracket section, the embedded branch coating at the first opening and the first positioning ring structure are fixed at the window opening.
进一步的,所述第一变高支架段包括至少两根第一矮棱和至少两根第一高棱,所有所述第一矮棱依次衔接后分别与依次衔接的所有第一高棱再衔接形成环状波浪形结构,其中,所述第一矮棱的棱高小于所述第一高棱的棱高;Further, the first height-increasing bracket section includes at least two first short ribs and at least two first high ribs, and all the first short ribs are connected in sequence and then connected to all the first high ribs that are connected in sequence. Forming an annular wavy structure, wherein the edge height of the first short edge is smaller than the edge height of the first high edge;
所述内嵌分支结构设有所述第一矮棱和所述第一高棱的一端作为所述第二开口,所述内嵌分支结构仅设有所述第一高棱的一端作为所述第一开口;The embedded branch structure is provided with the first short edge and one end of the first high edge as the second opening, and the embedded branch structure is provided with only one end of the first high edge as the second opening. First opening;
所述内嵌分支结构中靠近其中第一开口处没有第一矮棱支撑的覆膜区域为空膜段,所述第二开口的朝向,由所述第一开口处设有内嵌分支覆膜的空膜段与所述开窗的近端侧或远端侧拼接来确定。In the embedded branch structure, the coating area near the first opening without the first short rib support is an empty film section. The direction of the second opening is determined by the embedded branch coating provided at the first opening. The empty membrane segment is determined by splicing with the proximal side or distal side of the window.
进一步的,位于所述第二开口处并且朝向所述主体部的部分所述内嵌分支覆膜与所述主体部相连。Further, a portion of the embedded branch coating located at the second opening and facing the main body part is connected to the main body part.
可选的,所述内嵌分支结构的轴向长度为2mm~18mm。Optionally, the axial length of the embedded branch structure is 2 mm to 18 mm.
可选的,所述覆膜段包括一窗口,所述窗口与两个所述开窗沿轴向间隔设置,所述窗口用于使所述主体部与肠系膜上动脉对接相通。Optionally, the coated section includes a window, which is axially spaced apart from the two opening windows, and is used to connect and communicate the main body part with the superior mesenteric artery.
进一步的,所述覆膜段包括主体支架和主体覆膜,所述主体覆膜包覆所 述主体支架,并使得所述主体支架的远端沿轴向形成封闭内腔,所述主体支架包括两个第二变高支架段和至少一个第一等高支架段,两个所述第二变高支架段沿所述主体支架的径向对称设置在所述主体支架的近端,所有所述第一等高支架段沿轴向依次间隔设置在所述主体支架的远端,所述窗口位于两个所述第二变高支架段之间的主体覆膜上,所述开窗设置在包覆所述第一等高支架段或者第二变高支架段的主体覆膜上。Further, the film-coated section includes a main body bracket and a main body coating, and the main body coating covers all The main body stent is formed such that the distal end of the main body stent forms a closed inner cavity along the axial direction. The main body stent includes two second variable-height stent segments and at least one first equal-height stent segment. The two second second stent segments are The variable height stent segments are symmetrically arranged at the proximal end of the main body stent along the radial direction of the main body stent, and all the first equal height stent segments are arranged at the distal end of the main body stent in sequence along the axial direction, and the window Located on the main body coating between the two second height-increasing bracket sections, the window is provided on the main body coating covering the first equal-height bracket section or the second height-changing bracket section.
进一步的,所述第二变高支架段包括两根第二矮棱和多根第二高棱,所有所述第二矮棱依次衔接后分别与依次衔接的所有所述第二高棱再衔接形成环状波浪形结构,所述第二矮棱的棱高小于所述第二高棱的棱高,所述窗口沿轴向位于两个所述第二变高支架段的所述第二矮棱之间。Further, the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected to all the second high ribs that are connected in sequence. An annular wavy structure is formed, the edge height of the second short edge is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short edge of the two second heightening bracket sections. between the edges.
进一步的,所述第一等高支架段由多个等长的棱柱首尾衔接形成环状波浪形结构;所述开窗位于相邻的两个棱柱之间,且两个所述开窗沿周向位于同一个所述第一等高支架段的主体覆膜上,或者两个所述开窗沿周向位于不同的所述第一等高支架段的主体覆膜上;或者,两个所述开窗沿周向位于包覆所述第二变高支架段的主体覆膜上。Furthermore, the first equal-height bracket section is formed by a plurality of equal-length prisms connected end to end to form an annular wavy structure; the window is located between two adjacent prisms, and the two windows are arranged along the perimeter. are located on the main body coating of the same first equal-height bracket segment, or the two windows are circumferentially located on the main body coating of different first equal-height bracket segments; or, two of the windows are located on the main body coating of different first equal-height bracket segments; The window is circumferentially located on the main body covering covering the second height-increasing bracket section.
进一步的,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构的第一开口和第二开口处均设有第一定位环结构,所述窗口处设有第二定位环结构,所述第一开口处的第一定位环结构位于所述主体覆膜的外侧,所述第二开口处的第一定位环结构位于所述主体覆膜的内侧,所述第二定位环结构位于所述主体覆膜的外侧。Further, the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and a first positioning ring structure is provided at both the first opening and the second opening of the embedded branch structure. , the window is provided with a second positioning ring structure, the first positioning ring structure at the first opening is located outside the main body coating, and the first positioning ring structure at the second opening is located at the main body On the inside of the coating, the second positioning ring structure is located on the outside of the main body coating.
进一步的,所述第二定位环结构和第一定位环结构均包括支撑丝和显影丝,所述支撑丝呈圆环状,所述显影丝缠绕在所述支撑丝上或所述显影丝和所述支撑丝平行设置。Further, the second positioning ring structure and the first positioning ring structure both include a supporting wire and a developing wire, the supporting wire is in an annular shape, the developing wire is wound around the supporting wire or the developing wire and The support wires are arranged in parallel.
进一步的,还包括束径结构,所述束径结构设置在所述主体支架与主体覆膜上,且所述束径结构包括束径线圈和缝合线圈,所述束径线圈沿周向环抱所述第二变高支架段和/或第一等高支架段,所述缝合线圈设置于所述第二变高支架段和/或第一等高支架段远端的顶点、近端的顶点或棱上。Further, it also includes a beam diameter structure, the beam diameter structure is arranged on the main body bracket and the main body coating, and the beam diameter structure includes a beam diameter coil and a suture coil, and the beam diameter coil surrounds all the parts along the circumferential direction. The second variable-height stent section and/or the first equal-height stent section, the suture coil is arranged at the apex of the distal end, the proximal end of the second variable-height stent section and/or the first equal-height stent section, or On the edge.
进一步的,所述缝合线圈设置于所述棱上,每个所述棱上设置两个所述 缝合线圈,两个所述缝合线圈与各自对应距离最近的顶点间的间距相等;或者,每个所述棱上设置一个所述缝合线圈,所述缝合线圈位于所述棱的中点上。Further, the suture coils are arranged on the edges, and two of the stitches are arranged on each edge. Sewing coils, the distance between the two sewing coils and their corresponding nearest vertices is equal; or, one sewing coil is provided on each edge, and the sewing coil is located at the midpoint of the edge.
进一步的,所述主体部还包括裸段,所述裸段的远端连接所述主体覆膜的近端,且所述裸段轴向上与所述主体支架的近端部分重叠。Further, the main body part further includes a bare section, the distal end of the bare section is connected to the proximal end of the main body coating, and the bare section overlaps the proximal end portion of the main body stent in the axial direction.
进一步的,所述裸段包括支架环和位于所述支架环近端的倒钩结构,所述倒钩结构包括倒钩和倒钩柄,所述倒钩柄的远端连接所述支架环,所述倒钩柄的近端连接所述倒钩的近端,所述倒钩的远端向远离所述支架环的轴线方向外翻,且所述倒钩与所述支架环的轴线的夹角为10°~70°。Further, the bare segment includes a stent ring and a barb structure located at the proximal end of the stent ring, the barb structure includes a barb and a barb handle, and the distal end of the barb handle is connected to the stent ring, The proximal end of the barb handle is connected to the proximal end of the barb, the distal end of the barb is everted away from the axis of the stent ring, and the clamp between the barb and the axis of the stent ring The angle is 10°~70°.
可选的,还包括拼接部,所述拼接部拼接在所述主体部的远端,所述拼接部包括第一拼接部,所述第一拼接部的近端连接所述主体部的远端。Optionally, it also includes a splicing part, the splicing part is spliced at the distal end of the main body part, the splicing part includes a first splicing part, the proximal end of the first splicing part is connected to the distal end of the main body part .
进一步的,所述拼接部还包括第二拼接部,所述第一拼接部的远端具有同侧分支和对侧分支,所述第二拼接部的近端连接所述同侧分支,并用于建立同侧髂动脉血流,所述对侧分支用于拼接后建立对侧髂动脉血流。Further, the splicing part further includes a second splicing part, the distal end of the first splicing part has an ipsilateral branch and a contralateral branch, and the proximal end of the second splicing part is connected to the ipsilateral branch and used for The ipsilateral iliac artery blood flow is established, and the contralateral branch is used to establish the contralateral iliac artery blood flow after splicing.
与现有技术相比,本发明的有益效果是:Compared with the prior art, the beneficial effects of the present invention are:
本发明提供一种覆膜支架,通过两个所述开窗用于使所述主体部与肾动脉对接相通;通过每个所述内嵌分支结构分别与一个所述开窗相连,两个所述内嵌分支结构均位于所述主体部的内腔中,且所述内嵌分支结构的朝向与所述肾动脉的开口朝向一致,以对肾动脉的开口流出的血流起到引流作用,并顺应血流的自然走向,使其更接近人体的原始血管形态,还降低了对配合使用的球扩覆膜支架或自膨支架的柔顺性要求,保证球扩覆膜支架或自膨支架远期良好的通畅率,还极大地避免了内嵌分支结构在与球扩覆膜支架或自膨支架体内拼接时可能产生的拼接内漏。The present invention provides a stent graft, which is used to connect the main body part and the renal artery through two said windows; each of the embedded branch structures is connected to one of the said windows, and the two said windows are connected to each other. The embedded branch structures are all located in the inner cavity of the main body, and the orientation of the embedded branch structures is consistent with the opening of the renal artery, so as to drain the blood flow out of the opening of the renal artery, It also follows the natural direction of blood flow, making it closer to the original blood vessel shape of the human body. It also reduces the compliance requirements for the ball-expanded stent graft or self-expanding stent used to ensure that the ball-expanded stent graft or self-expanding stent is far away from the blood vessel. The long-term good patency rate also greatly avoids the internal leakage that may occur when the embedded branch structure is spliced with a ball-expanded covered stent or a self-expanding stent in vivo.
进一步的,内嵌分支结构设有第一矮棱和第一高棱的一端作为所述第二开口,所述内嵌分支结构仅设有第一高棱的一端作为所述第一开口;第一开口处设有内嵌分支覆膜的空膜段与所述开窗的近端侧或远端侧拼接来确定第二开口的朝向,即使设有所述第一高棱和内嵌分支覆膜的部分形成所述内嵌分支结构的大弯侧,使仅设有内嵌分支覆膜的空膜段形成所述内嵌分支结构 的小弯侧,易于拼接,且本发明的第一变高支架段的设计可以保证小弯侧的柔顺性良好;小弯侧可以加强锚定配合使用的球扩覆膜支架或自膨支架,同时降低覆膜支架整体的压握尺寸,进而降低了对入路血管直径的要求。Further, the embedded branch structure is provided with a first short edge and one end of the first high edge as the second opening, and the embedded branch structure is provided with only one end of the first high edge as the first opening; An empty film section with an embedded branch coating at an opening is spliced with the proximal or distal side of the window to determine the direction of the second opening, even if there is a first high edge and an embedded branch coating. The part of the membrane forms the large curved side of the embedded branch structure, so that only the empty membrane section provided with the embedded branch coating forms the embedded branch structure. The small curved side is easy to splice, and the design of the first variable-height stent segment of the present invention can ensure good flexibility on the small curved side; the small curved side can be strengthened to anchor the ball-expanded covered stent or self-expanding stent used in conjunction with it. At the same time, the overall pressing size of the covered stent is reduced, thereby reducing the requirement for the diameter of the access blood vessel.
进一步的,主体部、第一拼接部和第二拼接部的拼接,以及窗口、开窗和内嵌分支结构均集中设置在主体部中,使得主体部根据需求进行设计,第一拼接部和第二拼接部可以批量生产无需专门定制,从而使得第一拼接部和第二拼接部制备难度降低,可以快速配货及交货,大大缩短了穿着的等待时间,同侧分支可直接重建同侧髂动脉血流,与市场上的采用同侧髂动脉支架体内拼接相比,消除了该处的III型内漏,还降低了手术的经济成本和时间成本。Further, the splicing of the main body, the first splicing part and the second splicing part, as well as the window, the window opening and the embedded branch structure are all centrally arranged in the main part, so that the main part can be designed according to the needs, and the first splicing part and the second splicing part can be designed according to the needs. The second splicing part can be mass-produced without special customization, which makes the preparation of the first splicing part and the second splicing part less difficult, allows for quick distribution and delivery, greatly shortening the waiting time for wearing, and the same side branch can directly reconstruct the same side of the iliac Arterial blood flow, compared with the ipsilateral iliac artery stent intracorporeal splicing on the market, eliminates type III endoleak there, and also reduces the economic cost and time cost of the operation.
进一步的,所述第二变高支架段包括两根第二矮棱和多根第二高棱,所有所述第二矮棱依次衔接后分别与依次衔接的所有第二高棱再衔接形成环状波浪形结构,所述第二矮棱的棱高小于所述第二高棱的棱高,所述窗口沿轴向位于两个所述第二变高支架段的第二矮棱之间。该结构可以提高覆膜支架近端的柔顺性,第二矮棱可以避让肠系膜上动脉开窗,同时两个第二矮棱的对称分布既可给开窗(即肠系膜上动脉开窗)提供足够的避让空间,又可以为与肠系膜上动脉开窗水平方向上平齐的覆膜提供足够的径向支撑力,保障与肠系膜上动脉开窗水平方向上平齐的覆膜与腹主动脉的紧密贴合。Further, the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected with all the second high ribs in sequence to form a ring. It has a wavy structure, the edge height of the second short rib is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short ribs of the two second heightening bracket sections. This structure can improve the flexibility of the proximal end of the stent graft. The second short rib can avoid superior mesenteric artery fenestration. At the same time, the symmetrical distribution of the two second short ribs can provide sufficient space for fenestration (ie, superior mesenteric artery fenestration). The avoidance space can also provide sufficient radial support for the coating that is flush with the superior mesenteric artery window in the horizontal direction, ensuring the tightness of the coating that is flush with the superior mesenteric artery window in the horizontal direction with the abdominal aorta. fit.
附图说明Description of the drawings
图1为本发明一实施例的一种覆膜支架的结构示意图;Figure 1 is a schematic structural diagram of a stent graft according to an embodiment of the present invention;
图2为本发明一实施例的主体部的结构示意图;Figure 2 is a schematic structural diagram of the main body of an embodiment of the present invention;
图3a-3c为本发明一实施例的内嵌分支结构的不同朝向的结构示意图;Figures 3a-3c are structural schematic diagrams of the embedded branch structure in different directions according to an embodiment of the present invention;
图4为本发明一实施例的包裹有内嵌分支覆膜的第一变高支架段的周向展开后的示意图;Figure 4 is a schematic diagram of the first variable-height stent segment wrapped with an embedded branch coating according to an embodiment of the present invention after circumferential expansion;
图5为本发明一实施例的拼接部的结构示意图。FIG. 5 is a schematic structural diagram of the splicing part according to an embodiment of the present invention.
附图标记说明:Explanation of reference symbols:
1-主体部;2-拼接部;3-肠系膜上动脉窗口;4-内嵌分支结构; 1-Main part; 2-Splicing part; 3-Superior mesenteric artery window; 4-Embedded branch structure;
100-裸段;110-支架环;120-倒钩柄;130-倒钩;141-8字型显影点;142-O字型显影点;200-第一覆膜段;210、220-第二变高支架段;211、221-第二矮棱;212、222-第二高棱;300-第二覆膜段;310-第一等高支架段;311-棱柱;410-第一变高支架段;411-第一矮棱;412-第一高棱;413-大弯侧;414-小弯侧;415-空腹段;420-内嵌分支覆膜;400a-第一开口;400b-第二开口;500-束径结构;510-束径线圈;520-缝合线圈;600-第一拼接部;610-主体下段;611-第二等高支架段;620-分叉段;621-同侧分支;622-对侧分支;623-椭环支架段;700-第二拼接部;710-第一等径段;720-过渡段;730-第二等径段。100-bare section; 110-stent ring; 120-barb handle; 130-barb; 141-8-shaped developing point; 142-O-shaped developing point; 200-first coated section; 210, 220-th Two variable height bracket sections; 211, 221 - the second short edge; 212, 222 - the second high edge; 300 - the second coated section; 310 - the first equal height bracket section; 311 - prism; 410 - the first variable height High stent section; 411-first short edge; 412-first high edge; 413-larger curved side; 414-smaller curved side; 415-fasting section; 420-embedded branch coating; 400a-first opening; 400b -Second opening; 500-beam diameter structure; 510-beam diameter coil; 520-suture coil; 600-first splicing part; 610-lower section of main body; 611-second equal height bracket section; 620-bifurcation section; 621 -ipsilateral branch; 622-contralateral branch; 623-elliptical stent segment; 700-second splicing part; 710-first equal diameter section; 720-transition section; 730-second equal diameter section.
具体实施方式Detailed ways
以下将对本发明的一种覆膜支架作进一步的详细描述。下面将参照附图对本发明进行更详细的描述,其中表示了本发明的优选实施例,应该理解本领域技术人员可以修改在此描述的本发明而仍然实现本发明的有利效果。因此,下列描述应当被理解为对于本领域技术人员的广泛知道,而并不作为对本发明的限制。The stent graft of the present invention will be described in further detail below. The invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, it being understood that those skilled in the art may modify the invention described herein while still achieving the advantageous effects of the invention. Therefore, the following description should be understood as being widely known to those skilled in the art and is not intended to limit the present invention.
为了清楚,不描述实际实施例的全部特征。在下列描述中,不详细描述公知的功能和结构,因为它们会使本发明由于不必要的细节而混乱。应当认为在任何实际实施例的开发中,必须做出大量实施细节以实现开发者的特定目标,例如按照有关系统或有关商业的限制,由一个实施例改变为另一个实施例。另外,应当认为这种开发工作可能是复杂和耗费时间的,但是对于本领域技术人员来说仅仅是常规工作。In the interest of clarity, not all features of an actual embodiment are described. In the following description, well-known functions and constructions are not described in detail since they would obscure the invention with unnecessary detail. It is understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's particular goals, such as changing from one embodiment to another in accordance with relevant system or relevant business constraints. Additionally, it should be appreciated that such development efforts may be complex and time consuming, but are simply routine tasks for those skilled in the art.
为使本发明的目的、特征更明显易懂,下面结合附图对本发明的具体实施方式作进一步的说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比率,仅用以方便、明晰地辅助说明本发明实施例的目的。本文中,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外。本文所使用的术语“内”、“外”、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。本文中,术语“远端”、“近端”均是从使用该医疗器械的医生的角度来看相对于彼此的元件或动作的相对方位、相对 位置、方向,尽管“远端”、“近端”并非是限制性的,但是“远端”通常是指该医疗器械在正常操作过程中靠近操作者的一端,“近端”通常是指靠近患者的心脏的一端。本文中,术语“棱高”指的是例如图2中第二变高支架段中相邻的两个顶点A和A’在覆膜支架轴向上的长度。本文中,“横向”指的是垂直于主体部的轴线的方向,也就是图1中从左到右的方向。In order to make the purpose and features of the present invention more obvious and understandable, specific implementation modes of the present invention will be further described below with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and use imprecise ratios, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. As used herein, the term "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise. The terms "inner", "outer", and similar expressions used herein are for illustrative purposes only and do not represent the only implementation manner. In this article, the terms "distal" and "proximal" refer to the relative orientation, relative position, relative position, relative position, and relative position of components or actions relative to each other from the perspective of a physician using the medical device. Position and direction. Although "distal" and "proximal" are not restrictive, "distal" usually refers to the end of the medical device that is close to the operator during normal operation, and "proximal" usually refers to the end that is close to the operator during normal operation. One end of the patient's heart. Herein, the term "edge height" refers to, for example, the length of the two adjacent vertices A and A' in the second heightening stent segment in Figure 2 in the axial direction of the stent graft. In this article, "lateral" refers to the direction perpendicular to the axis of the main body, that is, the direction from left to right in Figure 1 .
图1为本实施例的一种覆膜支架的结构示意图。如图1所示,本实施例提供一种覆膜支架,所述覆膜支架可以用于治疗起始位置在肠系膜上动脉下方且与肠系膜上动脉下缘距离大于4mm的腹主动脉瘤。图2为本实施例的主体部的结构示意图。如图1和图2所示,所述覆膜支架包括主体部1和拼接部2,所述拼接部2的近端连接所述主体部1的远端。所述主体部1用于设置在主动脉内脏区。Figure 1 is a schematic structural diagram of a stent graft in this embodiment. As shown in Figure 1, this embodiment provides a covered stent that can be used to treat abdominal aortic aneurysms whose starting position is below the superior mesenteric artery and the distance from the lower edge of the superior mesenteric artery is greater than 4 mm. Figure 2 is a schematic structural diagram of the main body of this embodiment. As shown in Figures 1 and 2, the stent graft includes a main body part 1 and a splicing part 2. The proximal end of the splicing part 2 is connected to the distal end of the main body part 1. The main body part 1 is used to be arranged in the visceral area of the aorta.
所述主体部1包括裸段100和覆膜段,所述裸段100的远端与所述覆膜段的近端连接,所述裸段100用于锚定所述覆膜支架近端。所述覆膜段包括主体支架和主体覆膜,所述主体覆膜包覆所述主体支架,并使得所述主体支架的远端沿轴向形成封闭内腔。所述主体覆膜包覆在所述主体支架上形成所述覆膜段。所述主体部1的覆膜段可以使动脉瘤与血流隔绝并使血流从覆膜支架内部流过。The main body 1 includes a bare section 100 and a covered section. The distal end of the bare section 100 is connected to the proximal end of the covered section. The bare section 100 is used to anchor the proximal end of the covered stent. The coating section includes a main body stent and a main body coating. The main body coating covers the main body stent and causes the distal end of the main body stent to form a closed inner cavity along the axial direction. The main body coating is wrapped on the main body bracket to form the coating section. The covered section of the main body 1 can isolate the aneurysm from the blood flow and allow the blood flow to flow through the inside of the covered stent.
所述覆膜段包括沿轴向设置的第一覆膜段200和第二覆膜段300,所述第一覆膜段200的近端的主体覆膜与所述裸段100的远端连接,所述第一覆膜段200的远端的主体覆膜与所述第二覆膜段300的近端的主体覆膜连接。所述第一覆膜段200的主体覆膜上开设有肠系膜上动脉窗口3,所述肠系膜上动脉窗口3用于与肠系膜上动脉连通;所述第二覆膜段300的主体覆膜上设有内嵌分支结构4,所述内嵌分支结构4用于与肾动脉连通。本实施例中的覆膜支架从裸段100到第一覆膜段200均能提供用于锚定所述覆膜支架的近端的径向支撑力。所述裸段100、第一覆膜段200和第二覆膜段300的径向截面呈环状,且所述裸段100、第一覆膜段200和第二覆膜段300的直径相同。The coating section includes a first coating section 200 and a second coating section 300 arranged along the axial direction. The main body coating of the proximal end of the first coating section 200 is connected to the distal end of the bare section 100 , the main body coating at the distal end of the first coating section 200 is connected to the main body coating at the proximal end of the second coating section 300 . The superior mesenteric artery window 3 is provided on the main body coating of the first covered segment 200, and the superior mesenteric artery window 3 is used to communicate with the superior mesenteric artery; the main body covering of the second covered segment 300 is provided with a superior mesenteric artery window 3. There is an embedded branch structure 4, which is used to communicate with the renal artery. The stent graft in this embodiment can provide radial support force for anchoring the proximal end of the stent graft from the bare section 100 to the first covered section 200 . The radial cross-sections of the bare section 100, the first coated section 200 and the second coated section 300 are annular, and the diameters of the bare section 100, the first coated section 200 and the second coated section 300 are the same. .
所述裸段100用于将覆膜支架的近端与正常血管锚定在一起,同时用于延长覆膜支架的锚定区域以及在覆膜支架与输送器配合时达到裸段后释放的 目的。为了保证裸段100与正常血管的充分贴壁,所述裸段100需要具备足够的径向支撑力,其实现的方式包括但不限于所述裸段由316不锈钢、钴铬合金或镍钛合金管径切割而成。The bare section 100 is used to anchor the proximal end of the stent graft with the normal blood vessel, and is used to extend the anchoring area of the stent graft and to be released after reaching the bare section when the stent graft cooperates with the delivery device. Purpose. In order to ensure that the bare segment 100 fully adheres to normal blood vessels, the bare segment 100 needs to have sufficient radial support. The ways to achieve this include but are not limited to the bare segment being made of 316 stainless steel, cobalt-chromium alloy or nickel-titanium alloy. Pipe diameter cut.
为了进一步的提高裸段100的锚定效果,所述裸段100具有多个倒钩结构,所述倒钩结构用于锚定所述覆膜支架的近端。如图2所示,所述裸段100包括一个呈波浪状的支架环110,该波浪状的支架环100具有良好径向可伸缩性,以便于裸段压握,也能够提供锚定支撑力。所述支架环100的直径为18mm-38mm,以适配血管的尺寸。所述倒钩结构设置在所述支架环110靠近所述裸段100的近端的波峰(顶点M)上。In order to further improve the anchoring effect of the bare segment 100, the bare segment 100 has multiple barb structures, and the barb structures are used to anchor the proximal end of the stent graft. As shown in Figure 2, the bare segment 100 includes a wavy stent ring 110. The wavy stent ring 100 has good radial stretchability to facilitate the bare segment to be pressed and held, and can also provide anchoring support. . The diameter of the stent ring 100 is 18mm-38mm to adapt to the size of blood vessels. The barb structure is disposed on the crest (vertex M) of the stent ring 110 near the proximal end of the bare segment 100 .
所述倒钩结构包括倒钩柄120和倒钩130,所述倒钩柄120的远端连接所述支架环110靠近所述裸段的近端的顶点M上,用于支撑所述倒钩130,所述倒钩130的近端连接在所述倒钩柄120的近端,所述倒钩130和所述倒钩柄120分别成型后连接,例如分别切割成型后再通过焊接连接,或者,所述倒钩130与倒钩柄120为一体式结构,例如可以是一体切割形成。所述倒钩130的远端为自由端,其向远离所述支架环110的轴线的方向外翻,且所述倒钩130与所述支架环110的轴线的夹角为10°~70°,所述倒钩结构便于实现覆膜支架从输送器中完全释放前的倒钩保护,使覆膜支架在半束缚状态下在血管腔内进行调整时不会划伤血管。所述倒钩130的长度为1mm~6mm,且所述倒钩130的远端呈锥形。所述裸段100的上述形状的配合可在覆膜支架的半束缚状态下为其他耗材的导入提供空间。The barb structure includes a barb handle 120 and a barb 130. The distal end of the barb handle 120 is connected to the vertex M of the stent ring 110 near the proximal end of the bare segment for supporting the barbs. 130. The proximal end of the barb 130 is connected to the proximal end of the barb handle 120. The barb 130 and the barb handle 120 are connected after being formed separately. For example, they are cut and formed separately and then connected by welding, or , the barb 130 and the barb handle 120 are an integral structure, for example, they can be cut and formed in one piece. The distal end of the barb 130 is a free end, which is everted away from the axis of the stent ring 110 , and the angle between the barb 130 and the axis of the stent ring 110 is 10° to 70°. , the barb structure facilitates the barb protection before the stent graft is completely released from the transporter, so that the stent graft will not scratch the blood vessel when it is adjusted in the blood vessel cavity in a semi-constrained state. The length of the barb 130 is 1 mm to 6 mm, and the distal end of the barb 130 is tapered. The above-mentioned shape cooperation of the bare section 100 can provide space for the introduction of other consumables in the semi-bound state of the stent graft.
在本实施例中,所述裸段100的远端缝合在所述第一覆膜段200的近端的主体覆膜上,所述裸段100轴向上与所述主体支架的近端部分重叠,即所述裸段100的远端与所述第一覆膜段200的近端沿所述主体支架的轴向具有重叠区域,且所述裸段100的远端靠近所述第一覆膜段200的近端的顶点M’位于所述重叠区域,且所述裸段100靠近所述第一覆膜段200的近端的顶点M’到所述主体覆膜的近端边缘的距离为2mm~4mm,这样,所述裸段100与第一覆膜段200的近端的第二变高支架段在主体支架的轴向存在重叠区(例如距离第一覆膜段的近端边缘附近2mm处,所述裸段100与第一覆膜段的近 端的第二变高支架段在主体支架的轴向存在重叠),可以增加覆膜支架的径向支撑的点位,使得覆膜支架的近端的圆整形更好,从而有效防止由于覆膜支架的近端与血管内壁贴合不紧密产生的Ia型内漏。In this embodiment, the distal end of the bare section 100 is sutured to the main body covering of the proximal end of the first covered section 200 , and the bare section 100 is axially connected to the proximal part of the main body stent. Overlap, that is, the distal end of the bare segment 100 and the proximal end of the first covered segment 200 have an overlapping area along the axial direction of the main body stent, and the distal end of the bare segment 100 is close to the first covered segment 200 . The distance from the vertex M' of the proximal end of the membrane segment 200 to the proximal edge of the main body membrane is located in the overlapping area, and the bare segment 100 is close to the distance from the apex M' of the proximal end of the first membrane segment 200. is 2 mm to 4 mm. In this way, the bare segment 100 and the second higher height stent segment at the proximal end of the first covered segment 200 have an overlapping area in the axial direction of the main stent (for example, from the proximal edge of the first covered segment At a distance of 2 mm, the distance between the bare section 100 and the first coated section is The second higher stent segment at the end overlaps in the axial direction of the main stent), which can increase the radial support point of the stent graft, making the proximal end of the stent graft better rounded, thereby effectively preventing the stent graft from being Type Ia endoleak occurs when the proximal end does not fit closely with the inner wall of the blood vessel.
所述第一覆膜段200包括两个第二变高支架段,在本实施例中,所述第一覆膜段200包括两个第二变高支架段210、220,两个所述第二变高支架段210、220横向对称设置在所述主体支架的近端(即两个所述第二变高支架段210、220沿主体支架的径向对称,且设置在主体支架的近端),且两个第二变高支架段210、220沿所述主体支架的轴向间隔设置,两个所述第二变高支架段210、220之间的最小的轴向间距为1mm~6mm,两个所述第二变高支架段210、220之间的轴向间距可以根据血管弯曲程度进行调整,以便于调整肠系膜上动脉窗口附近的第二变高支架段的柔顺性,最终完全适配血管走向。当肠系膜上动脉开口处腹主动脉血管弯曲程度严重时,可以增加两个第二变高支架段之间的轴向间距,反之,则可以减小两个第二变高支架段之间的轴向间距。The first film-coated section 200 includes two second variable-height bracket sections. In this embodiment, the first film-coated section 200 includes two second variable-height bracket sections 210 and 220. The two second variable-height bracket sections 210 and 220. The two second variable height stent sections 210 and 220 are symmetrically arranged at the proximal end of the main body stent (that is, the two second variable height stent sections 210 and 220 are symmetrical along the radial direction of the main body stent and are arranged at the proximal end of the main body stent). ), and the two second variable-height bracket sections 210 and 220 are spaced apart along the axial direction of the main body bracket, and the minimum axial distance between the two second variable-height bracket sections 210 and 220 is 1 mm to 6 mm. , the axial spacing between the two second variable height stent segments 210, 220 can be adjusted according to the degree of blood vessel curvature, so as to adjust the compliance of the second variable height stent segment near the superior mesenteric artery window, and finally fully adapt to the situation. Match the direction of blood vessels. When the degree of curvature of the abdominal aorta at the opening of the superior mesenteric artery is severe, the axial distance between the two second variable height stent segments can be increased; conversely, the axial distance between the two second variable height stent segments can be reduced. direction spacing.
所述第二变高支架段210可使覆膜支架的近端与正常血管壁贴合地更加紧密,以有效防止由覆膜支架的近端与正常血管壁贴合不紧所产生的Ia型内漏。在本实施例中,所述第二变高支架段210与裸段100作为覆膜支架的近端的锚定区域,它们均能提供用于锚定所述覆膜支架的近端的径向支撑力,且共同保证覆膜支架的近端与正常血管的充分贴壁。The second increased height stent section 210 can make the proximal end of the stent graft fit more closely with the normal blood vessel wall, thereby effectively preventing type Ia caused by the loose fit of the proximal end of the stent graft with the normal blood vessel wall. Internal leakage. In this embodiment, the second increased-height stent segment 210 and the bare segment 100 serve as anchoring areas for the proximal end of the stent graft, and both of them can provide radial areas for anchoring the proximal end of the stent graft. supporting force, and jointly ensure the full adhesion between the proximal end of the covered stent and the normal blood vessel.
在本实施例中,所述第二变高支架段210、220为完全相同的两个支架,所述第二变高支架段210包括第二矮棱211和第二高棱212,第二变高支架段220包括第二矮棱221和第二高棱222,其中,第二矮棱211、221的数量为2根,第二高棱212、222的数量为多根,所有的第二矮棱211依次衔接后分别与所有的依次衔接的第二高棱212再衔接形成了环形波浪状的第二变高支架段210,所有的第二矮棱221依次衔接后分别与所有的依次衔接的第二高棱222再衔接形成了环形波浪状的第二变高支架段220。其中,所述第二矮棱211、221的棱高小于第二高棱212、222的棱高,且所述第二矮棱211、221的棱高为2mm~8mm,所述第二高棱212、222的棱高为8mm~16mm。由于第二高棱 和第二矮棱的棱高均较小,形成的第二变高支架段210、220沿覆膜支架的轴向的长度较小,可以提高覆膜支架的近端的柔顺性。由于第二变高支架段210、220横向对称设置,因此,第二变高支架段210的两根第二矮棱衔接后在其远端形成的顶点A与第二变高支架段220的两根第二矮棱衔接后在其近端形成的顶点A’正对设置,第二变高支架段210的任两根第二高棱衔接后在其远端形成的顶点与第二变高支架段220的其中两根第二高棱衔接后其近端形成的顶点正对设置,这就造成顶点A与顶点A’之间的间距为第二变高支架段210在其远端的顶点与其正对的第二变高支架段220在其近端的顶点中距离最大的。该间距可以有效的为肠系膜上动脉窗口3预留空间,因此,该第二矮棱211、221的设计主要用于避让肠系膜上动脉窗口3,还可以用于在径向上为包裹所述第二变高支架段210、220的覆膜提供足够的径向支撑力,以保证肠系膜上动脉窗口3的周围的覆膜与腹主动脉的紧密贴合。根据血管的尺寸,所述顶点A、A’分别与肠系膜上动脉窗口3之间的间距小于3mm。In this embodiment, the second height-changing bracket sections 210 and 220 are two identical brackets. The second height-changing bracket section 210 includes a second short edge 211 and a second high edge 212. The tall bracket section 220 includes a second short rib 221 and a second high rib 222, wherein the number of the second short ribs 211 and 221 is two, the number of the second tall ribs 212 and 222 is multiple, and all the second short ribs 211 and 222 are in number. The ribs 211 are connected in sequence and then connected to all the second high ribs 212 in sequence to form an annular wavy second height-increasing bracket section 210. All the second short ribs 221 are connected in sequence and connected in sequence to all the second short ribs 212 in sequence. The second high edges 222 are then connected to form an annular wavy second height-increasing bracket section 220 . Wherein, the edge height of the second short ribs 211 and 221 is smaller than the edge height of the second high ribs 212 and 222, and the edge height of the second short ribs 211 and 221 is 2 mm to 8 mm. The second high rib The edge height of 212 and 222 is 8mm~16mm. Because the second highest edge The edge heights of the second short edge and the second short edge are both small, and the length of the second heightening stent segments 210 and 220 formed along the axial direction of the stent graft is smaller, which can improve the flexibility of the proximal end of the stent graft. Since the second height-changing bracket sections 210 and 220 are arranged laterally symmetrically, the apex A formed at the distal end of the second height-changing bracket section 210 after the two second short edges of the second height-changing bracket section 210 are connected and the two second height-changing bracket sections 220 are connected. The apex A' formed at the proximal end of the second short rib after being connected is arranged directly opposite to the apex formed at the distal end of any two second high edges of the second height-increasing stent section 210 after being connected with the second height-increasing stent. The vertices formed by the proximal ends of the two second high edges of the segment 220 are facing each other, which causes the distance between the vertex A and the vertex A' to be the distal vertex of the second height-increasing stent segment 210 and its The opposite second heightening stent section 220 has the greatest distance at its proximal apex. This spacing can effectively reserve space for the superior mesenteric artery window 3. Therefore, the design of the second short ribs 211 and 221 is mainly used to avoid the superior mesenteric artery window 3, and can also be used to wrap the second short ribs 211 and 221 in the radial direction. The coating of the increased-height stent segments 210 and 220 provides sufficient radial support force to ensure that the coating around the superior mesenteric artery window 3 adheres closely to the abdominal aorta. According to the size of the blood vessel, the distance between the vertices A and A' and the superior mesenteric artery window 3 is less than 3 mm.
所述肠系膜上动脉窗口3用于重塑肠系膜上动脉的血流通畅。所述肠系膜上动脉窗口3包括在顶点A、A’之间的主体覆膜上裁出的窗口(例如圆形窗口)以及设置在所述窗口处的第二定位环结构,优选的,所述第二定位环结构为圆环形结构,且所述第二定位环结构缝制在所述窗口外侧的主体覆膜上,所述肠系膜上动脉窗口3的尺寸为所述第二定位环结构的内径的尺寸,以使得肠系膜上动脉窗口3与肠系膜上动脉的开口对准。所述第二定位环结构由支撑丝和显影丝构成,进一步的,所述支撑丝和显影丝平行设置(相互独立,不缠绕)或所述支撑丝和显影丝相互缠绕,第二定位环结构的组成既保证肠系膜上动脉开窗的刚度要求,又保证射线下的位置跟踪,从而增加了覆膜支架的可视性,也方便了手术操作。其中,所述支撑丝的材质为316不锈钢、钴铬合金或镍钛合金等,所述显影丝的材质为显影性良好的黄金等。优选的,所述支撑丝和所述显影丝呈圆环状,所述支撑丝和显影丝形成的圆环的直径相同。作为优选的技术方案,所述显影丝在支撑丝的本体上缠绕(例如螺旋缠绕),从而形成圆环状的所述第二定位环结构。所述第二定位环结构的内直径为6mm~14mm,以匹配肠系膜上动脉的开口直径。所述肠系膜上动 脉窗口3内可以放置球扩覆膜支架或自膨支架重建肠系膜上动脉血流。The superior mesenteric artery window 3 is used to reshape the blood flow of the superior mesenteric artery smoothly. The superior mesenteric artery window 3 includes a window (such as a circular window) cut out on the main body covering between the vertices A and A' and a second positioning ring structure disposed at the window. Preferably, the The second positioning ring structure is a circular structure, and the second positioning ring structure is sewn on the main body covering outside the window. The size of the superior mesenteric artery window 3 is the size of the second positioning ring structure. The inner diameter is sized such that the superior mesenteric artery window 3 is aligned with the opening of the superior mesenteric artery. The second positioning ring structure is composed of a supporting wire and a developing wire. Furthermore, the supporting wire and the developing wire are arranged in parallel (independent of each other and not entangled) or the supporting wire and the developing wire are entangled with each other. The second positioning ring structure The composition not only ensures the stiffness requirements of the superior mesenteric artery window opening, but also ensures position tracking under rays, thereby increasing the visibility of the covered stent and facilitating surgical operations. Wherein, the material of the supporting wire is 316 stainless steel, cobalt-chromium alloy or nickel-titanium alloy, etc., and the material of the developing wire is gold with good developability, etc. Preferably, the support wire and the development wire are in the shape of a ring, and the diameters of the rings formed by the support wire and the development wire are the same. As a preferred technical solution, the developing wire is wound around the body of the supporting wire (for example, spirally wound), thereby forming the annular second positioning ring structure. The inner diameter of the second positioning ring structure is 6 mm to 14 mm to match the opening diameter of the superior mesenteric artery. The mesenteric upward movement A ball-expanded covered stent or a self-expanding stent can be placed in the pulse window 3 to reconstruct the superior mesenteric artery blood flow.
所述第二覆膜段300用于支撑血管壁,以提高覆膜支架的贴壁性。所述第二覆膜段300包括至少一个第一等高支架段310,所述第一等高支架段由多个等长的棱柱311首尾衔接形成环形波浪状的支架段。所述第一等高支架段310可有效的为内嵌分支结构4预留空间。其中,所述第二变高支架段210、220和至少一个第一等高支架段310沿所述覆膜支架的轴向依次间隔设置,且通过主体覆膜固定连接。所述棱柱311的棱高为6mm~12mm,由于棱柱311的棱高较小,可以保证覆膜支架的整体的柔顺性。第二变高支架段220与其相邻的第一等高支架段310之间的间距为1mm~5mm。当第一等高支架段310数量至少为两个时,相邻的第一等高支架段310之间的间距为1mm~5mm,且至少两个第一等高支架段310可以沿轴向均匀分布,也可以沿轴向非均匀分布,以达到避让内嵌分支结构4的开口的目的。The second covered section 300 is used to support the blood vessel wall to improve the adhesion of the covered stent. The second coating section 300 includes at least one first equal-height bracket section 310. The first equal-height bracket section is formed by a plurality of equal-length prisms 311 connected end to end to form an annular wave-shaped bracket section. The first equal-height bracket section 310 can effectively reserve space for the embedded branch structure 4 . Wherein, the second variable-height bracket sections 210 and 220 and at least one first equal-height bracket section 310 are sequentially spaced along the axial direction of the covered stent and are fixedly connected through the main body coating. The edge height of the prism 311 is 6 mm to 12 mm. Since the edge height of the prism 311 is small, the overall flexibility of the stent graft can be ensured. The distance between the second variable-height bracket section 220 and its adjacent first equal-height bracket section 310 is 1 mm to 5 mm. When the number of first equal-height bracket segments 310 is at least two, the spacing between adjacent first equal-height bracket segments 310 is 1 mm to 5 mm, and at least two first equal-height bracket segments 310 can be uniform along the axial direction. The distribution may also be non-uniformly distributed along the axial direction to achieve the purpose of avoiding the opening of the embedded branch structure 4 .
所述主体部还包括两个内嵌分支结构4,所述内嵌分支结构4设置在所述第二覆膜段300的主体覆膜上,以使得覆膜支架的内部通过两个内嵌分支结构4分别与两个肾动脉连通。在本实施例中,位于所述第二覆膜段300的主体覆膜上具有两个开窗,两个所述开窗可以沿周向设置在同一个第一等高支架段310中的两个相邻的棱柱之间,也可以设置在不同第一等高支架段310中的两个相邻的棱柱之间。在其他实施例中,两个所述开窗还可以设置在包覆第二变高支架段的主体覆膜上,且两个所述开窗沿周向位于包覆所述第二变高支架段的主体覆膜上。每个开窗分别与一个肾动脉的开口对准,且每个开窗均用于连接一个内嵌分支结构4。手术时可在内嵌分支结构内放置球扩覆膜支架或自膨支架重建肾动脉血流。The main body part also includes two inline branch structures 4. The inline branch structures 4 are provided on the main body coating of the second coating section 300, so that the interior of the stent graft passes through the two inline branches. Structure 4 is connected to two renal arteries respectively. In this embodiment, there are two openings on the main body coating of the second coating section 300, and the two openings can be disposed circumferentially on two sides of the same first equal-height bracket section 310. Between two adjacent prisms, it can also be provided between two adjacent prisms in different first equal-height bracket sections 310 . In other embodiments, the two opening windows may also be provided on the main body covering covering the second height-increasing bracket section, and the two opening windows are circumferentially located on the main body covering the second height-increasing bracket segment. The main body of the segment is covered with film. Each fenestration is aligned with the opening of a renal artery, and each fenestration is used to connect an embedded branch structure 4 . During surgery, a ball-expanding covered stent or a self-expanding stent can be placed within the embedded branch structure to reconstruct renal artery blood flow.
所述内嵌分支结构4包括第一变高支架段、内嵌分支覆膜420和两个第一定位环结构,所述内嵌分支覆膜420包裹所述第一变高支架段,以形成轴向贯通的管状结构,即内嵌分支结构4为两端开口的管状结构,为便于描述,两端开口分别为第一开口400a,第二开口400b。具体地,在管状结构的第一开口400a和第二开口400b处均固定有所述第一定位环结构,其中,与第一开口400a相连的第一定位环结构,其先置于主体覆膜的外表面上,再衔接内 嵌分支结构4。所述内嵌分支结构4设置在所述覆膜支架的内腔,且所述第一开口处的内嵌分支结构4和所述第一定位环结构固定在所述开窗处,且所述第一开口处的第一定位环结构位于所述主体覆膜的外侧,第二开口400b为没有连接结构的自由端,所述第二开口处的第一定位环结构位于所述主体覆膜的内侧。所述第一定位环结构与第二定位环结构的材料及形状分别相同,所述第一定位环结构的内直径为3mm~9mm,以匹配人体肾动脉血管直径。The embedded branch structure 4 includes a first variable-height bracket section, an embedded branch coating 420 and two first positioning ring structures. The embedded branch coating 420 wraps the first variable-height bracket section to form The axially penetrating tubular structure, that is, the embedded branch structure 4 is a tubular structure with openings at both ends. For convenience of description, the openings at both ends are respectively the first opening 400a and the second opening 400b. Specifically, the first positioning ring structure is fixed at both the first opening 400a and the second opening 400b of the tubular structure. The first positioning ring structure connected to the first opening 400a is first placed on the main body coating. on the outer surface, and then connect the inner Embedded branch structure 4. The embedded branch structure 4 is provided in the inner cavity of the stent graft, and the embedded branch structure 4 and the first positioning ring structure at the first opening are fixed at the window, and the The first positioning ring structure at the first opening is located on the outside of the main body coating. The second opening 400b is a free end without a connecting structure. The first positioning ring structure at the second opening is located on the outside of the main body coating. inside. The first positioning ring structure and the second positioning ring structure are made of the same material and shape respectively, and the inner diameter of the first positioning ring structure is 3 mm to 9 mm to match the diameter of the human renal artery.
靠近所述第二开口处的内嵌分支覆膜朝向所述主体部侧的部分与所述主体部相连。详细的,图3a-3c为本实施例的内嵌分支结构的不同朝向的结构示意图。如图3a-3c所示,所述内嵌分支结构4的朝向根据血管走向设计,具体的,所述内嵌分支结构4的朝向(即内嵌分支结构4的第二开口的朝向)与肾动脉的开口朝向一致。如图3b所示,当肾动脉开口在腹主动脉附近走向朝向近端(即上方)的,可将所述内嵌分支结构4的第二开口朝向近端(即上方),以顺应血管的自然走向,降低了对配合使用的球扩覆膜支架或自膨支架的柔顺性要求,同时也更接近人体的原始血管形态,保证球扩覆膜支架或自膨支架远期良好的通畅率。如图3a所示,当肾动脉开口朝向远端(即下方)的,可将内嵌分支结构4的第二开口朝向远端(即下方),也可起到上述同样的效果。如图3c所示,当肾动脉在腹主动脉附近走向基本水平(即所述肾动脉的开口朝向与所述主体部的轴向垂直),可采用水平方式进行缝制来降低对球扩覆膜支架或自膨支架的柔顺性要求,此时所述第二开口水平设置,即内嵌分支结构4的第二开口与肾动脉开口的连线与所述主体部的轴向垂直。本实施例中内嵌分支结构4的缝制方式可以为朝上缝制、朝下缝制和水平缝制,因此,两个内嵌分支结构4根据患者血管走向组合使用可以形成双朝上、双朝下、双水平、一朝上一朝下、一水平一朝上或一水平一朝下等组合,所述两个内嵌分支结构4的朝向可以通过第二开口缝合控制朝向,也可以通过空膜段的尺寸控制。The portion of the embedded branch coating near the second opening facing the main body is connected to the main body. In detail, Figures 3a-3c are schematic structural diagrams of the embedded branch structure in different directions in this embodiment. As shown in Figures 3a-3c, the orientation of the embedded branch structure 4 is designed according to the direction of the blood vessels. Specifically, the orientation of the embedded branch structure 4 (that is, the orientation of the second opening of the embedded branch structure 4) is consistent with the direction of the kidney. The openings of the arteries are oriented in the same direction. As shown in Figure 3b, when the opening of the renal artery near the abdominal aorta moves towards the proximal end (i.e. above), the second opening of the embedded branch structure 4 can be directed towards the proximal end (i.e. above) to comply with the flow of the blood vessel. The natural trend reduces the compliance requirements for the ball-expanded stent graft or self-expanding stent used, and is also closer to the original blood vessel shape of the human body, ensuring good long-term patency of the ball-expanded stent graft or self-expanding stent. As shown in Figure 3a, when the opening of the renal artery faces the distal end (that is, downward), the second opening of the embedded branch structure 4 can be directed toward the distal end (that is, downward), and the same effect as above can be achieved. As shown in Figure 3c, when the renal artery runs essentially horizontally near the abdominal aorta (that is, the opening of the renal artery is oriented perpendicular to the axis of the main body), sewing can be performed horizontally to reduce bulbar expansion. The flexibility of the membrane stent or the self-expanding stent requires that the second opening be set horizontally, that is, the connection line between the second opening of the embedded branch structure 4 and the opening of the renal artery is perpendicular to the axial direction of the main body. In this embodiment, the sewing methods of the embedded branch structures 4 can be upward sewing, downward sewing, and horizontal sewing. Therefore, the two embedded branch structures 4 can be combined according to the direction of the patient's blood vessels to form a double upward, downward sewing, or horizontal sewing. Combinations such as double downward, double horizontal, one upward and one downward, one horizontal and one upward, or one horizontal and one downward. The orientation of the two embedded branch structures 4 can be controlled by the second opening suture, or can be Through the size control of the empty membrane segment.
图4为本实施例的包裹有内嵌分支覆膜的第一变高支架段的周向展开后的示意图。如图4所示,所述第一变高支架段410包括第一矮棱411和第一高棱412,所有的第一矮棱和第一高棱分别依次首尾衔接后再衔接形成了环形 波浪状的支架段,且所述支架段的至少一端上的所有顶点的连线在同一直线上。其中,第一矮棱411的数量为4根~8根,第一高棱412的数量为4根~8根,且所有的第一矮棱411依次衔接后与所有的第一高棱412依次衔接。其中,所述第一矮棱411的棱高小于所述第一高棱412的棱高,且所述第一矮棱411的棱高为2mm~10mm,所述第一高棱412的棱高为3mm~16mm。FIG. 4 is a schematic diagram of the first variable-height stent segment wrapped with an embedded branch coating in this embodiment after circumferential expansion. As shown in Figure 4, the first height-increasing bracket section 410 includes a first short edge 411 and a first high edge 412. All the first short edges and the first high edges are connected end to end in sequence and then connected to form a ring shape. A wavy bracket segment, and the lines connecting all vertices on at least one end of the bracket segment are on the same straight line. Among them, the number of the first short ribs 411 is 4-8, the number of the first high ribs 412 is 4-8, and all the first short ribs 411 are connected with all the first high ribs 412 in sequence. connection. Wherein, the edge height of the first short edge 411 is smaller than the edge height of the first high edge 412, and the edge height of the first short edge 411 is 2 mm to 10 mm, and the edge height of the first high edge 412 is 3mm~16mm.
进一步的,所述第一变高支架段410的一端上的所有顶点的连线在同一直线上,即所述内嵌分支结构4设有第一矮棱和第一高棱的一端的所有顶点位于同一直线上,则该端为所述第二开口,则另一端(即所有顶点连线不在同一直线上的一端,也就是所有顶点连线为曲线或折线的一端)为所述内嵌分支结构仅设有第一高棱的一端,作为所述第一开口。具体来说,由于第一矮棱411和第一高棱412的棱高差,内嵌分支结构4中靠近其中第一开口处没有第一矮棱411支撑的覆膜区域为空膜段415,见图4所示,当内嵌分支结构4的第一开口400a与开窗处拼接时,通过调整第一开口400a上空膜段415与开窗的近端侧或远端侧拼接,即可确定第二开口400b的方向。其原理为:通过空膜段415与开窗的近端侧或远端侧在缝制时缩进第二开口400b与空膜段对应侧的距离,即形成了靠近主体覆膜的小弯侧414,以及与小弯侧414相对的大弯侧413。本实施例中,所述大弯侧413位于所述第一变高支架段410中所有的第一高棱412衔接的区域,所述小弯侧414位于空膜段415。小弯侧414的弯曲程度较大弯侧413的弯曲程度大,对内嵌分支结构4的柔顺性要求高,因此本实施例中将空膜段415形成该小弯侧414。Furthermore, the connecting lines of all the vertices on one end of the first height-increasing bracket section 410 are on the same straight line, that is, all the vertices of one end of the embedded branch structure 4 are provided with the first short edge and the first high edge. If they are on the same straight line, then this end is the second opening, and the other end (that is, the end where all the vertex lines are not on the same straight line, that is, the end where all the vertex lines are curves or polylines) is the embedded branch. The structure is provided with only one end of the first high edge as the first opening. Specifically, due to the difference in height between the first short rib 411 and the first high rib 412, the coating area in the embedded branch structure 4 near the first opening that is not supported by the first short rib 411 is an empty film section 415. As shown in Figure 4, when the first opening 400a of the embedded branch structure 4 is spliced with the window opening, it can be determined by adjusting the empty membrane section 415 above the first opening 400a to be spliced with the proximal side or the distal side of the window. The direction of the second opening 400b. The principle is: by retracting the distance between the second opening 400b and the corresponding side of the empty film section between the empty film section 415 and the proximal side or the distal side of the window during sewing, a small curved side close to the main body film is formed. 414, and a large curved side 413 opposite the small curved side 414. In this embodiment, the large curved side 413 is located in the area where all the first high edges 412 in the first height-increasing bracket section 410 are connected, and the small curved side 414 is located in the empty membrane section 415 . The small curved side 414 has a greater degree of curvature than the curved side 413 , which requires high flexibility of the embedded branch structure 4 . Therefore, in this embodiment, the empty film section 415 is used to form the small curved side 414 .
请继续参阅图3a-3c以及图4,在将内嵌分支结构4缝制至主体覆膜上,且内嵌分支结构4朝上或朝下缝制时,所述内嵌分支结构4的第一开口400a缝制在所述第二覆膜段的覆膜的开窗处,内嵌分支结构4的第二开口400b可以为自由端,也可以通过将靠近第二开口400b的内嵌分支覆膜420朝向主体覆膜的部分缝制在所述第二覆膜段的主体覆膜上,以将内嵌分支结构4的第二开口400b固定在第二覆膜段的覆膜上,具体的,内嵌分支结构4缝制在所述第二覆膜段的主体覆膜上。进一步的,所述第二开口400b的朝向,由所述第一开口400a处设有内嵌分支覆膜的部分(即空膜段415)与所述开窗的近 端侧或远端侧拼接来确定。具体可为,缝制时,将第一开口400a缝制在第二覆膜段的覆膜的开窗处。如图3a和图4所示,以内嵌分支结构4第二开口朝下缝制为例,内嵌分支结构4的第一开口400a对应开窗,且空膜段415位于开窗的远端侧,采用如图4的第一变高支架段来缝制方法,即:根据方向需要,第一开口400a处,将设有第一高棱412的区域与开窗的远端侧对应,将仅有内嵌分支覆膜420的空膜段415与开窗的远端侧对应,同时第一定位环结构置于开窗处的覆膜的外表面;内嵌分支结构4的内嵌分支覆膜420从开窗处伸出至第二覆膜段的外表面,并包覆第一定位环结构,以此缝制,通过控制空膜段415处伸出开窗的长度可控制内嵌分支结构4的倾斜角度,这样可以保证小弯侧414的柔顺性良好,还可以降低覆膜支架整体的压握尺寸,进而降低覆膜支架对入路血管直径的要求。当内嵌分支结构4与球扩覆膜支架或自膨支架配合使用时,由于空膜段415没有支架支撑,故球扩覆膜支架或自膨支架在空膜段的球扩(膨胀)尺寸更大,可使球扩覆膜支架或自膨支架卡在第一变高支架段的第一矮棱411和第一定位环结构之间。Please continue to refer to Figures 3a-3c and Figure 4. When the embedded branch structure 4 is sewn to the main body film, and the embedded branch structure 4 is sewn upward or downward, the third part of the embedded branch structure 4 An opening 400a is sewn at the opening of the film of the second film section. The second opening 400b of the embedded branch structure 4 can be a free end, or it can be covered by covering the embedded branch close to the second opening 400b. The part of the film 420 facing the main body coating is sewn on the main body coating of the second coating section to fix the second opening 400b of the embedded branch structure 4 on the coating of the second coating section. Specifically, , the embedded branch structure 4 is sewn on the main body coating of the second coating section. Further, the orientation of the second opening 400b is determined by the portion of the first opening 400a where the branch film is embedded (i.e., the empty film section 415) and the portion near the window. End-side or distal-side splicing to determine. Specifically, during sewing, the first opening 400a is sewn at the window opening of the film of the second film section. As shown in Figures 3a and 4, taking the second opening of the embedded branch structure 4 being sewn downward as an example, the first opening 400a of the embedded branch structure 4 corresponds to the window, and the empty film section 415 is located on the far end side of the window. , adopt the sewing method of the first height-increasing bracket segment as shown in Figure 4, that is: according to the direction requirements, at the first opening 400a, the area provided with the first high edge 412 corresponds to the far end side of the window, and only The empty film section 415 with the embedded branch coating 420 corresponds to the distal side of the window, and the first positioning ring structure is placed on the outer surface of the coating at the window; the embedded branch coating of the embedded branch structure 4 420 extends from the window opening to the outer surface of the second coating section, and covers the first positioning ring structure. By sewing, the embedded branch structure can be controlled by controlling the length of the empty film section 415 extending out of the window. The tilt angle is 4, which can ensure good compliance of the small curved side 414, and can also reduce the overall pressing size of the stent graft, thereby reducing the requirements of the stent graft on the diameter of the access blood vessel. When the embedded branch structure 4 is used with a ball-expanded stent graft or a self-expanding stent, since the empty membrane section 415 is not supported by the stent, the ball-expanded (expansion) size of the ball-expanded stent graft or self-expanding stent in the empty membrane section If it is larger, the ball-expanded stent graft or the self-expanding stent can be stuck between the first short edge 411 of the first height-increasing stent section and the first positioning ring structure.
在将内嵌分支结构4缝制至主体覆膜上,且内嵌分支结构4水平缝制时,所述内嵌分支结构4的第一开口缝制在所述第二覆膜段的覆膜的开窗处,也就是说,当配合使用的球扩覆膜支架入路为远端时,第一变高支架段410的第二开口400b朝向远端,降低了覆膜支架的压握尺寸,以便于压握。同时,当配合使用的球扩覆膜支架,球扩覆膜支架在内嵌分支结构内腔撑开时,球扩覆膜支架在空膜段具有更大膨胀空间,从而加固锚定球扩覆膜支架,防止移位。当配合使用的球扩覆膜支架入路为近端时,第一变高支架段的第二开口400b朝向近端,以起到同样的效果。When the embedded branch structure 4 is sewn to the main body coating, and the embedded branch structure 4 is sewn horizontally, the first opening of the embedded branch structure 4 is sewn to the coating of the second coating section. The opening of the window, that is to say, when the access point of the ball-expanded stent graft used is the distal end, the second opening 400b of the first heightening stent section 410 faces the distal end, reducing the pressing size of the stent graft. , for easy pressing and holding. At the same time, when used with the ball-expanded stent graft, when the ball-expanded stent graft is expanded in the inner cavity of the embedded branch structure, the ball-expanded stent graft has a larger expansion space in the empty membrane segment, thereby reinforcing the anchoring ball-expanded stent graft. Membrane stent to prevent displacement. When the approach of the ball-expanded stent graft used is the proximal end, the second opening 400b of the first heightening stent section faces the proximal end to achieve the same effect.
在其他实施例中,当肾动脉在腹主动脉附近走向基本水平时,内嵌分支结构可包括等高支架段、内嵌分支覆膜和第一定位环结构,所述内嵌分支覆膜包裹所述等高支架段,所述等高支架段包括多个首尾衔接的等高棱。In other embodiments, when the renal artery runs substantially horizontally near the abdominal aorta, the embedded branch structure may include a contoured stent segment, an embedded branch coating and a first positioning ring structure, the embedded branch coating wrapping The equal height support section includes a plurality of equal height edges connected end to end.
所述内嵌分支结构4的轴向长度为2mm~18mm,可以保证肾动脉的血流畅通,还极大地避免了主体部1与球扩覆膜支架或自膨支架体内拼接时可能产生的拼接内漏(即III型内漏)。 The axial length of the embedded branch structure 4 is 2 mm to 18 mm, which can ensure the smooth blood flow of the renal artery and greatly avoid possible splicing when the main body 1 is spliced with the ball-expanding covered stent or self-expanding stent in vivo. Endoleak (i.e. type III endoleak).
如图5所示,所述拼接部2包括位于近端的第一拼接部600和位于远端的第二拼接部700,所述第一拼接部600为管状结构,所述第一拼接部600为一体式分叉结构,且第一拼接部600的远端包括自近端向远端的方向分开为两个管状腿部结构,即同侧分支621和对侧分支622,其中,同侧分支621的轴向长度较对侧分支622的轴向长度长或者短或者相同。所述第一拼接部600的近端与所述主体部1的远端连接,所述同侧分支621的远端与第二拼接部700的近端连接。所述主体部1位于人体主动脉内脏区,主要用于提供覆膜支架近端的密封性,以及向内脏分支重建提供通路。所述第一拼接部600位于瘤腔内,主要用于在腹主动脉瘤瘤腔内提供封闭的血流通道,以隔绝腹主动脉瘤瘤腔。所述第二拼接部700位于腹主动脉瘤瘤腔的远端并延伸至患者的同侧髂动脉内。在本实施例中,所述主体部1、第一拼接部600和第二拼接部700分别通过缝合方式拼接成为一个覆膜支架整体。与市场上的采用同侧髂动脉支架体内拼接相比,缝合式的一体支架消除了该处的III型内漏,降低了手术的经济成本和时间成本,同时该种拼接结构可实现快速交货,让患者尽可能的减少等待时间。同侧即为与输送系统入路方向相同的一侧,对侧即为与同侧相对的一侧。As shown in Figure 5, the splicing part 2 includes a first splicing part 600 located at the proximal end and a second splicing part 700 located at the distal end. The first splicing part 600 is a tubular structure. The first splicing part 600 It is an integrated bifurcated structure, and the distal end of the first splicing part 600 is divided into two tubular leg structures from the proximal end to the distal end, namely the ipsilateral branch 621 and the contralateral branch 622, wherein the ipsilateral branch The axial length of 621 is longer, shorter, or the same as the axial length of the contralateral branch 622. The proximal end of the first splicing part 600 is connected to the distal end of the main body part 1 , and the distal end of the same side branch 621 is connected to the proximal end of the second splicing part 700 . The main body part 1 is located in the visceral area of the human aorta and is mainly used to provide sealing of the proximal end of the stent graft and to provide access for reconstruction of the visceral branches. The first splicing part 600 is located in the aneurysm cavity and is mainly used to provide a closed blood flow channel in the abdominal aortic aneurysm cavity to isolate the abdominal aortic aneurysm cavity. The second splicing part 700 is located at the distal end of the abdominal aortic aneurysm cavity and extends into the ipsilateral iliac artery of the patient. In this embodiment, the main body part 1, the first splicing part 600 and the second splicing part 700 are spliced together by suturing to form a whole stent graft. Compared with the intracorporeal splicing of ipsilateral iliac artery stents on the market, the sutured one-piece stent eliminates type III endoleak, reduces the economic cost and time cost of the operation, and at the same time, this splicing structure can achieve rapid delivery. , allowing patients to reduce waiting time as much as possible. The ipsilateral side is the side in the same direction as the entrance of the delivery system, and the contralateral side is the side opposite the ipsilateral side.
所述第一拼接部600包括主体下段610、分叉段620和第一拼接覆膜,主体下段610设置在分叉段620的近端,且所述第一拼接覆膜包覆所述主体下段610和分叉段620,所述第一拼接覆膜的近端连接主体部1的主体覆膜的远端。其中,所述主体下段610包括至少一个第二等高支架段611,所述第二等高支架段的形状、直径、材料等均分别与第一等高支架段310的形状、直径、材料相同。所述第一拼接覆膜包裹至少一个所述第二等高支架段611。The first splicing part 600 includes a main body lower section 610, a bifurcation section 620 and a first splicing coating. The main body lower section 610 is provided at the proximal end of the bifurcation section 620, and the first splicing coating covers the main body lower section. 610 and bifurcated section 620, the proximal end of the first splicing coating is connected to the distal end of the main body coating of the main body part 1. The lower body section 610 includes at least one second equal-height bracket section 611 . The shape, diameter, and material of the second equal-height bracket section are the same as those of the first equal-height bracket section 310 . . The first splicing coating wraps at least one of the second equal-height bracket sections 611 .
所述分叉段620包括波浪形的椭环支架段623,所述椭环支架段623的近端的径向截面为圆形,其远端的径向截面为椭圆形,且所述椭环支架段623自近端向远端的径向截面的长轴和短轴均逐渐减小,以使得分叉段620的分叉平滑。所述同侧分支621的支架段和对侧分支622的支架段的直径、材料、形状均分别相同,其中,所述对侧分支622的支架段采用等高支架,使得对侧分支622的径向直径为定直径设计,其可以更好的配合对侧髂动脉分支支 架段的使用,用于拼接后建立对侧髂动脉血流;所述同侧分支621的支架段也采用等高支架,使得同侧分支621的径向直径为定直径设计,使得第二拼接部700与其等直径连接,从而有利于第二拼接部700的批量生产。The bifurcated section 620 includes a wavy elliptical ring stent section 623. The radial cross section of the proximal end of the elliptical ring stent section 623 is circular, and the radial cross section of the distal end is oval, and the elliptical ring stent section 623 Both the major axis and the minor axis of the radial cross section of the stent segment 623 gradually decrease from the proximal end to the distal end, so as to make the bifurcation of the bifurcated segment 620 smooth. The diameter, material and shape of the stent section of the ipsilateral branch 621 and the stent section of the contralateral branch 622 are all the same. The stent section of the contralateral branch 622 adopts a constant height stent, so that the diameter of the contralateral branch 622 is The diameter is fixed diameter design, which can better match the contralateral iliac artery branches. The use of stent segments is used to establish contralateral iliac artery blood flow after splicing; the stent segment of the ipsilateral branch 621 also uses a constant height stent, so that the radial diameter of the ipsilateral branch 621 is a fixed diameter design, so that the second splicing The parts 700 are connected with equal diameters, thereby facilitating mass production of the second splicing part 700 .
所述第二拼接部700的近端连接在所述同侧分支621的远端,进一步的,所述第二拼接部700的覆膜的近端缝制在同侧分支621的远端的第一拼接覆膜上。所述第二拼接部700包括沿轴向依次连接的第一等径段710、过渡段720和第二等径段730,所述第一等径段710的近端连接同侧分支621的远端,所述过渡段720的近端连接第一等径段710的远端,所述过渡段720的远端连接第二等径段730的近端,第一等径段710的支架段和第二等径段730的支架段均为等高支架,且均为波浪形环状结构,第一等径段710支架段直径与同侧分支的支架段的直径相同,且第二等径段730的直径较第一等径段710的直径大,过渡段720的支架段为变直径支架,使得过渡段720的直径由近端向远端逐渐增大。所述第二等径段730的直径与过渡段720的远端直径相等,具体的,第二等径段730的直径为6mm~28mm,长度为20mm~180mm。所述第二等径段730用于将所述第二拼接部700与病变血管的管壁贴合,还用于第二等径段730的远端的密封。其中,所述同侧分支621、所述第一等径段710、所述过渡段720和所述第二等径段730的长度之和大于所述对侧分支622。The proximal end of the second splicing part 700 is connected to the distal end of the same side branch 621. Furthermore, the proximal end of the coating of the second splicing part 700 is sewn to the third distal end of the same side branch 621. A splicing film is applied. The second splicing part 700 includes a first equal diameter section 710, a transition section 720 and a second equal diameter section 730 that are connected in sequence along the axial direction. The proximal end of the first equal diameter section 710 is connected to the distal end of the same side branch 621. end, the proximal end of the transition section 720 is connected to the distal end of the first equal diameter section 710, the distal end of the transition section 720 is connected to the proximal end of the second equal diameter section 730, the bracket section of the first equal diameter section 710 and The stent sections of the second equal-diameter section 730 are all equal-height stents and have a wavy annular structure. The diameter of the stent section of the first equal-diameter section 710 is the same as the diameter of the stent section of the branch on the same side, and the second equal-diameter section The diameter of 730 is larger than the diameter of the first equal-diameter section 710, and the stent section of the transition section 720 is a variable-diameter stent, so that the diameter of the transition section 720 gradually increases from the proximal end to the distal end. The diameter of the second equal diameter section 730 is equal to the diameter of the distal end of the transition section 720. Specifically, the diameter of the second equal diameter section 730 is 6 mm to 28 mm, and the length is 20 mm to 180 mm. The second equal diameter section 730 is used to fit the second splicing portion 700 to the wall of the diseased blood vessel, and is also used to seal the distal end of the second equal diameter section 730 . The sum of the lengths of the ipsilateral branch 621 , the first equal diameter section 710 , the transition section 720 and the second equal diameter section 730 is greater than the opposite side branch 622 .
请继续参阅图2,主体覆膜的近端设置有两种显影点来实现射线下覆膜支架近端的位置标定,所述显影点分别为O字型显影点142和8字型显影点141,所述O字型显影点142和8字型显影点141沿主体覆膜的近端周向均匀分布。Please continue to refer to Figure 2. The proximal end of the main body coating is provided with two developing points to realize the position calibration of the proximal end of the stent graft under rays. The developing points are respectively an O-shaped developing point 142 and an 8-shaped developing point 141. , the O-shaped developing points 142 and 8-shaped developing points 141 are evenly distributed along the proximal circumferential direction of the main body coating.
在本实施例中,主体覆膜的近端设置有一个8字型显影点141和三个O字型显影点142,每个显影点之间的间距相同(每个显影点之间的夹角为90°),且所述8字型显影点141设置在覆膜支架的同侧或对侧,三个O字型显影点142设置在其他三个方向。In this embodiment, an 8-shaped developing point 141 and three O-shaped developing points 142 are provided at the proximal end of the main body coating, and the spacing between each developing point is the same (the angle between each developing point is 90°), and the 8-shaped developing point 141 is arranged on the same side or the opposite side of the stent graft, and the three O-shaped developing points 142 are arranged in the other three directions.
为了实现覆膜支架的束径功能,所述覆膜支架还包括束径结构500,所述束径结构设置在所述主体支架与主体覆膜上。所述束径结构500包括多个束径线圈510和多个缝合线圈520,所述束径线圈510由PTFE、PET或超高分 子聚乙烯等具有良好生物相容性的软性高分子材料制成。所述束径线圈510沿周向环抱所述第二变高支架段和/或第一等高支架段,即每个支架段(例如第二变高支架段、第一等高支架段、第一变高支架段、第二等高支架段、主体下段的支架段等)中至少一个具有至少两个所述束径线圈510。在本实施例中,每个支架段均具有两个所述束径线圈510,两个所述束径线圈510可以重叠,也可以沿覆膜支架的轴向间隔设置,且所述束径线圈510可以设置在支架段的棱中或者顶点的任意位置,具体根据实际需求进行设置。两个所述束径线圈510一端可以从同一点或不同点往相反方向出发,沿周向“抱住”支架段,两个束径线圈510沿周向“抱住”支架段后,主体导丝穿过两个束径线圈的另一端,从而在径向上束缚支架段,以达到束经的效果。在本实施例中,两个所述束径线圈510间隔设置,且分别设置在各支架段的近端和/或远端的顶点上。In order to realize the beam diameter function of the stent graft, the stent graft also includes a beam diameter structure 500, which is provided on the main body stent and the main body coating. The beam diameter structure 500 includes a plurality of beam diameter coils 510 and a plurality of suture coils 520. The beam diameter coils 510 are made of PTFE, PET or ultra-high resolution. Made of soft polymer materials with good biocompatibility such as polyethylene. The beam diameter coil 510 circumferentially surrounds the second variable-height bracket segment and/or the first equal-height bracket segment, that is, each bracket segment (for example, the second variable-height bracket segment, the first equal-height bracket segment, the third At least one of a variable-height bracket section, a second equal-height bracket section, a bracket section of the lower body section, etc.) has at least two beam diameter coils 510 . In this embodiment, each stent segment has two beam diameter coils 510. The two beam diameter coils 510 can overlap or be arranged at intervals along the axial direction of the covered stent, and the beam diameter coils 510 can be set in the edge or at any position at the vertex of the bracket segment, and can be set according to actual needs. One end of the two beam diameter coils 510 can start from the same point or different points in opposite directions, and "hug" the bracket segment in the circumferential direction. After the two beam diameter coils 510 "hug" the bracket segment in the circumferential direction, the main body guide The wire passes through the other ends of the two beam diameter coils to constrain the stent segments in the radial direction to achieve the beam beam effect. In this embodiment, the two beam diameter coils 510 are arranged at intervals and are respectively arranged at the vertices of the proximal end and/or the distal end of each stent segment.
所述缝合线圈520为缝制在所述主体部的主体覆膜,以及第二等高支架段的第一拼接覆膜上的中空线圈,其直径为0.5mm~2mm。缝合线圈520设置于每个支架段远端的顶点(即A顶点)处、近端的顶点(即A’顶点)处或者棱上。当缝合线圈520设置于每个支架段的棱上时,每个棱上可以设置两个缝合线圈520,两个缝合线圈与各自对应最近的顶点间距相等;每个棱上还可以设置一个缝合线圈520,该缝合线圈520位于棱的中点位置上,即其与两侧的顶点的间距均相等,或者,位于所述第二变高支架段和/或第一等高支架段远端的顶点、近端的顶点上。A顶点即为每个支架段的波谷处,A’顶点即为每个支架段的波峰处。The suture coil 520 is a hollow coil sewn on the main body coating of the main body part and the first splicing coating of the second equal-height stent section, and its diameter is 0.5 mm to 2 mm. The suture coil 520 is disposed at the vertex of the distal end of each stent segment (i.e., vertex A), the vertex of the proximal end (ie, vertex A'), or on the edge. When the suture coils 520 are disposed on the edges of each stent segment, two suture coils 520 can be disposed on each edge, and the two suture coils are equally spaced from their corresponding nearest vertices; one suture coil can also be disposed on each edge. 520, the suture coil 520 is located at the midpoint of the edge, that is, the distance between it and the vertices on both sides is equal, or is located at the vertex of the distal end of the second variable-height stent segment and/or the first equal-height stent segment. , on the proximal vertex. The A vertex is the trough of each stent segment, and the A’ vertex is the crest of each stent segment.
在本实施例中,所述束径线圈510穿设在缝合线圈中,且在所有缝合线圈与支架段的重叠位置处穿过缝合线圈后环抱支架段,使得缝合线圈520在A顶点、A’顶点或棱上将各支架段与包裹其的覆膜固定,该结构简单易操作,效果牢靠。采用这种结构可有效避免释放时线结点被卡住导致的支架段无法弹开。所述束径线圈510穿过缝合线圈520后被限制住,只可在圆周方向上移动,保证束径的稳定性。通过调整束径线圈的长度,可调整束径的比例为名义直径的40%-90%。 In this embodiment, the beam diameter coil 510 is inserted into the suture coil, and passes through the suture coil at the overlapping positions of all suture coils and stent segments before surrounding the stent segment, so that the suture coil 520 is at the A vertex, A' Each bracket segment is fixed to the covering film wrapping it at the vertex or edge. The structure is simple and easy to operate and has a reliable effect. Adopting this structure can effectively avoid the stent segment being unable to spring out due to the wire nodes being stuck during release. The beam diameter coil 510 is restricted after passing through the suture coil 520 and can only move in the circumferential direction to ensure the stability of the beam diameter. By adjusting the length of the beam diameter coil, the ratio of the beam diameter can be adjusted from 40% to 90% of the nominal diameter.
需要说的是,所述束径线圈510和缝合线圈520在遇到所述开窗和窗口时需要进行避让。即所述束径线圈510不可挡住肠系膜上动脉窗口3和内嵌分支结构在主体覆膜上的开窗,因此,在肠系膜上动脉窗口3的第二定位环结构和内嵌分支结构4的第一定位环结构上,所述缝合线圈520将束径线圈510固定在肠系膜上动脉窗口3和内嵌分支结构4的外侧。在肠系膜上动脉窗口3和内嵌分支结构上的缝合线圈的数量可以分别为1个~4个。It needs to be said that the beam diameter coil 510 and the suture coil 520 need to be avoided when encountering the openings and windows. That is, the beam diameter coil 510 cannot block the opening of the superior mesenteric artery window 3 and the embedded branch structure on the main body coating. Therefore, the second positioning ring structure of the superior mesenteric artery window 3 and the second positioning ring structure of the embedded branch structure 4 On a certain positioning ring structure, the suture coil 520 fixes the beam diameter coil 510 on the outside of the superior mesenteric artery window 3 and the embedded branch structure 4. The number of suture coils on the superior mesenteric artery window 3 and the embedded branch structure can be 1 to 4 respectively.
所述第二变高支架段210、220、第一等高支架段310、第一变高支架段410、第二等高支架段611、主体下段610的支架段、分叉段620的支架段和第二拼接部700的支架的材料均为镍钛、钴铬合金或316不锈钢材料,形状为环形波浪状。所述主体覆膜、内嵌分支覆膜、主体下段覆膜、分叉段覆膜和第二拼接部700的覆膜的材料均为生物相容性好的高分子软性材料,可使支架段在轴向上形成封闭的内腔。The second variable-height bracket sections 210 and 220, the first equal-height bracket section 310, the first variable-height bracket section 410, the second equal-height bracket section 611, the bracket section of the lower body section 610, and the bracket section of the bifurcated section 620 The material of the bracket and the second splicing part 700 are all nickel-titanium, cobalt-chromium alloy or 316 stainless steel, and the shape is annular and wavy. The main body coating, embedded branch coating, main body lower section coating, bifurcation section coating and second splicing section 700 coating are all made of polymer soft materials with good biocompatibility, which can make the stent The segments form a closed inner cavity in the axial direction.
综上所述,本发明提供一种覆膜支架,通过两个所述开窗用于使所述主体部与肾动脉对接相通;通过每个所述内嵌分支结构分别与一个所述开窗相连,两个所述内嵌分支结构均位于所述主体部的内腔中,且所述内嵌分支结构的朝向与所述肾动脉的开口朝向一致,以对肾动脉的开口流出的血流起到引流作用,并顺应血流的自然走向,使其更接近人体的原始血管形态,还降低了对配合使用的球扩覆膜支架或自膨支架的柔顺性要求,保证球扩覆膜支架或自膨支架远期良好的通畅率,还极大地避免了内嵌分支结构在与球扩覆膜支架或自膨支架体内拼接时可能产生的拼接内漏。To sum up, the present invention provides a stent graft, which is used to connect and communicate the main body part with the renal artery through two of the fenestrations; and each of the embedded branch structures is connected to one of the fenestrations. connected, the two embedded branch structures are located in the inner cavity of the main body, and the orientation of the embedded branch structures is consistent with the opening of the renal artery, so as to control the blood flow out of the opening of the renal artery. It plays a drainage role and follows the natural direction of blood flow, making it closer to the original blood vessel shape of the human body. It also reduces the compliance requirements for the ball-expanded stent graft or self-expanding stent used to ensure that the ball-expanded stent graft is used. Or the good long-term patency rate of self-expanding stents also greatly avoids possible internal leakage when the embedded branch structure is spliced with the ball-expanded covered stent or self-expanding stent in vivo.
进一步的,位于所述第一高棱衔接区域的所述第一变高支架段和内嵌分支覆膜作为所述内嵌分支结构的大弯侧,位于所述第一矮棱衔接区域中没有所述第一矮棱支撑的所述内嵌分支覆膜作为所述内嵌分支结构的小弯侧,所述小弯侧位于所述第一开口处,使得所述第一矮棱避让所述第一开口。本发明的第一变高支架段的设计可以保证小弯侧的柔顺性良好;小弯侧可以加强锚定配合使用的球扩覆膜支架或自膨支架,同时降低覆膜支架整体的压握尺寸,进而降低了对入路血管直径的要求。Further, the first height-increasing stent segment and the embedded branch coating located in the first high-edge connection area serve as the large curved side of the embedded branch structure, and there are no The embedded branch coating supported by the first short rib serves as the small curved side of the embedded branch structure, and the small curved side is located at the first opening, so that the first short rib avoids the First to speak. The design of the first variable-height stent section of the present invention can ensure good compliance of the small curved side; the small curved side can strengthen the anchorage of the ball-expanded stent graft or self-expanding stent used, and at the same time reduce the overall pressure of the stent graft. size, thereby reducing the requirements for the diameter of the access vessel.
进一步的,主体部、第一拼接部和第二拼接部的拼接,以及窗口、开窗 和内嵌分支结构均集中设置在主体部中,使得主体部根据需求进行设计,第一拼接部和第二拼接部可以批量生产无需专门定制,从而使得第一拼接部和第二拼接部制备难度降低,可以快速配货及交货,大大缩短了穿着的等待时间,同侧分支可直接重建同侧髂动脉血流,与市场上的采用同侧髂动脉支架体内拼接相比,消除了该处的III型内漏,还降低了手术的经济成本和时间成本。Further, the splicing of the main body part, the first splicing part and the second splicing part, as well as the window and window opening and embedded branch structures are centrally arranged in the main body, so that the main body can be designed according to needs, and the first splicing part and the second splicing part can be mass-produced without special customization, making the preparation of the first splicing part and the second splicing part difficult. It can be quickly distributed and delivered, which greatly shortens the waiting time for wearing. The ipsilateral branch can directly reconstruct the ipsilateral iliac artery blood flow. Compared with the ipsilateral iliac artery stent in vivo splicing on the market, this problem is eliminated. Type III endoleak also reduces the economic cost and time cost of surgery.
进一步的,所述第二变高支架段包括两根第二矮棱和多根第二高棱,所有所述第二矮棱依次衔接后分别与依次衔接的所有第二高棱再衔接形成环状波浪形结构,所述第二矮棱的棱高小于所述第二高棱的棱高,所述窗口沿轴向位于两个所述第二变高支架段的第二矮棱之间。该结构可以提高覆膜支架近端的柔顺性,第二矮棱可以避让肠系膜上动脉开窗,同时两个第二矮棱的对称分布既可给开窗(即肠系膜上动脉开窗)提供足够的避让空间,又可以为与肠系膜上动脉开窗水平方向上平齐的覆膜提供足够的径向支撑力,保障与肠系膜上动脉开窗水平方向上平齐的覆膜与腹主动脉的紧密贴合。Further, the second height-increasing bracket section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence and then connected with all the second high ribs in sequence to form a ring. It has a wavy structure, the edge height of the second short rib is smaller than the edge height of the second high edge, and the window is located along the axial direction between the second short ribs of the two second heightening bracket sections. This structure can improve the flexibility of the proximal end of the stent graft. The second short rib can avoid superior mesenteric artery fenestration. At the same time, the symmetrical distribution of the two second short ribs can provide sufficient space for fenestration (ie, superior mesenteric artery fenestration). The avoidance space can also provide sufficient radial support for the coating that is flush with the superior mesenteric artery window in the horizontal direction, ensuring the tightness of the coating that is flush with the superior mesenteric artery window in the horizontal direction with the abdominal aorta. fit.
此外,需要说明的是,除非特别说明或者指出,否则说明书中的术语“第一”、“第二”、“第三”仅仅用于区分说明书中的各个组件、元素、步骤等,而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。In addition, it should be noted that, unless otherwise specified or pointed out, the terms "first", "second" and "third" in the specification are only used to distinguish various components, elements, steps, etc. in the specification, rather than to It is used to express the logical relationship or sequential relationship between various components, elements, steps, etc.
可以理解的是,虽然本发明已以较佳实施例披露如上,然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言,在不脱离本发明技术方案范围情况下,都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰,或修改为等同变化的等效实施例。因此,凡是未脱离本发明技术方案的内容,依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰,均仍属于本发明技术方案保护的范围内。 It can be understood that although the present invention has been disclosed above in preferred embodiments, the above embodiments are not intended to limit the present invention. For any person familiar with the art, without departing from the scope of the technical solution of the present invention, they can use the technical content disclosed above to make many possible changes and modifications to the technical solution of the present invention, or modify it into equivalent changes. Example. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims (19)

  1. 一种覆膜支架,其特征在于,包括主体部,所述主体部包括覆膜段和两个内嵌分支结构,所述覆膜段设置有两个开窗,两个所述开窗用于使所述主体部与肾动脉对接相通;每个所述内嵌分支结构分别设置在一个所述开窗处,并与所述开窗相连,两个所述内嵌分支结构均位于所述主体部的内腔中,且所述内嵌分支结构的朝向与肾动脉的开口朝向一致。A covered stent is characterized in that it includes a main body, the main body includes a covered section and two embedded branch structures, the covered section is provided with two windows, and the two windows are used for The main body part is connected with the renal artery; each of the embedded branch structures is respectively arranged at one of the window openings and is connected to the window opening, and both of the embedded branch structures are located on the main body part. in the inner cavity of the renal artery, and the orientation of the embedded branch structure is consistent with the opening orientation of the renal artery.
  2. 如权利要求1所述的覆膜支架,其特征在于,所述内嵌分支结构设置在所述覆膜支架的内腔且为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构包括第一变高支架段和内嵌分支覆膜,所述内嵌分支覆膜包裹所述第一变高支架段,所述第一开口处的内嵌分支覆膜固定在所述开窗处。The stent graft according to claim 1, wherein the embedded branch structure is disposed in the inner cavity of the stent graft and is an axially penetrating tubular structure having a first opening and a second opening, The embedded branch structure includes a first variable-height bracket segment and an embedded branch coating. The embedded branch coating wraps the first variable-height bracket segment, and the embedded branch coating at the first opening is fixed. at said window opening.
  3. 如权利要求1所述的覆膜支架,其特征在于,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述第一开口与对应的所述开窗相连;The stent graft of claim 1, wherein the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and the first opening is connected to the corresponding opening. Windows are connected;
    所述肾动脉的开口朝向所述主体部近端时,所述第二开口朝向所述主体部的近端设置;所述肾动脉的开口朝向所述主体部远端时,所述第二开口朝向所述主体部的远端设置;或者,所述肾动脉的开口朝向与所述主体部的轴向垂直时,所述第二开口水平设置。When the opening of the renal artery is toward the proximal end of the main body, the second opening is provided toward the proximal end of the main body; when the opening of the renal artery is toward the distal end of the main body, the second opening is disposed toward the distal end of the main body part; or, when the opening of the renal artery is oriented perpendicular to the axial direction of the main body part, the second opening is disposed horizontally.
  4. 如权利要求1所述的覆膜支架,其特征在于,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构包括第一变高支架段、内嵌分支覆膜和第一定位环结构,所述内嵌分支覆膜包裹所述第一变高支架段,所述第一开口处的内嵌分支覆膜和所述第一定位环结构固定在所述开窗处。The stent graft of claim 1, wherein the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and the embedded branch structure includes a first height-increasing The stent segment, the embedded branch coating and the first positioning ring structure, the embedded branch coating wraps the first variable height stent segment, the embedded branch coating at the first opening and the first positioning ring structure The ring structure is fixed at the opening.
  5. 如权利要求2所述的覆膜支架,其特征在于,The covered stent according to claim 2, characterized in that:
    所述第一变高支架段包括至少两根第一矮棱和至少两根第一高棱,所有所述第一矮棱依次衔接后分别与依次衔接的所有第一高棱再衔接形成环状波浪形结构,其中,所述第一矮棱的棱高小于所述第一高棱的棱高; The first height-increasing bracket section includes at least two first short ribs and at least two first high ribs. All the first short ribs are connected in sequence and then connected with all the first high ribs in sequence to form a ring. Wave-shaped structure, wherein the edge height of the first short edge is smaller than the edge height of the first high edge;
    所述内嵌分支结构设有所述第一矮棱和所述第一高棱的一端作为所述第二开口,所述内嵌分支结构仅设有所述第一高棱的一端作为所述第一开口;The embedded branch structure is provided with the first short edge and one end of the first high edge as the second opening, and the embedded branch structure is provided with only one end of the first high edge as the second opening. First opening;
    所述内嵌分支结构中靠近其中第一开口处没有第一矮棱支撑的覆膜区域为空膜段,所述第二开口的朝向,由所述第一开口处设有内嵌分支覆膜的空膜段与所述开窗的近端侧或远端侧拼接来确定。In the embedded branch structure, the coating area near the first opening without the first short rib support is an empty film section. The direction of the second opening is determined by the embedded branch coating provided at the first opening. The empty membrane segment is determined by splicing with the proximal side or distal side of the window.
  6. 如权利要求5所述的覆膜支架,其特征在于,位于所述第二开口处并且朝向所述主体部的部分所述内嵌分支覆膜与所述主体部相连。The stent graft of claim 5, wherein the portion of the embedded branch graft located at the second opening and facing the main body is connected to the main body.
  7. 如权利要求1所述的覆膜支架,其特征在于,所述内嵌分支结构的轴向长度为2mm~18mm。The stent graft of claim 1, wherein the axial length of the embedded branch structure is 2 mm to 18 mm.
  8. 如权利要求1所述的覆膜支架,其特征在于,所述覆膜段包括一窗口,所述窗口与两个所述开窗沿轴向间隔设置,所述窗口用于使所述主体部与肠系膜上动脉对接相通。The covered stent according to claim 1, wherein the covered section includes a window, the window is axially spaced apart from the two opening windows, and the window is used to make the main body part Connected with the superior mesenteric artery.
  9. 如权利要求8所述的覆膜支架,其特征在于,所述覆膜段包括主体支架和主体覆膜,所述主体覆膜包覆所述主体支架,并使得所述主体支架的远端沿轴向形成封闭内腔,所述主体支架包括两个第二变高支架段和至少一个第一等高支架段,两个所述第二变高支架段沿所述主体支架的径向对称设置在所述主体支架的近端,所有所述第一等高支架段沿轴向依次间隔设置在所述主体支架的远端,所述窗口位于两个所述第二变高支架段之间的主体覆膜上,所述开窗设置在包覆所述第一等高支架段或者第二变高支架段的主体覆膜上。The covered stent according to claim 8, wherein the covered section includes a main body stent and a main body coating, and the main body coating covers the main body stent and makes the distal end of the main body stent extend along the A closed inner cavity is formed in the axial direction, and the main body bracket includes two second height-increasing bracket segments and at least one first equal-height bracket segment, and the two second height-increasing bracket segments are arranged symmetrically along the radial direction of the main body bracket. At the proximal end of the main body stent, all the first equal-height stent segments are arranged in sequence at axial intervals at the distal end of the main body stent, and the window is located between the two second variable-height stent segments. On the main body coating, the window is provided on the main body coating covering the first equal height bracket section or the second variable height bracket section.
  10. 如权利要求9所述的覆膜支架,其特征在于,所述第二变高支架段包括两根第二矮棱和多根第二高棱,所有所述第二矮棱依次衔接后分别与依次衔接的所有所述第二高棱再衔接形成环状波浪形结构,所述第二矮棱的棱高小于所述第二高棱的棱高,所述窗口沿轴向位于两个所述第二变高支架段的所述第二矮棱之间。The stent graft of claim 9, wherein the second height-increasing stent section includes two second short ribs and a plurality of second high ribs, and all the second short ribs are connected in sequence with each other respectively. All the second high edges connected in sequence are connected to form an annular wavy structure, the edge height of the second short rib is smaller than the edge height of the second high edge, and the window is located along the axial direction between the two said between the second short edges of the second heightening bracket section.
  11. 如权利要求9所述的覆膜支架,其特征在于,所述第一等高支架段由多个等长的棱柱首尾衔接形成环状波浪形结构;所述开窗位于相邻的两个棱柱之间,且两个所述开窗沿周向位于同一个所述第一等高支架段的主体覆 膜上,或者两个所述开窗沿周向位于不同的所述第一等高支架段的主体覆膜上;或者,两个所述开窗沿周向位于包覆所述第二变高支架段的主体覆膜上。The covered stent according to claim 9, characterized in that the first equal-height stent section is formed by a plurality of equal-length prisms connected end to end to form an annular wavy structure; and the windows are located at two adjacent prisms. between them, and the two windows are circumferentially located on the main body covering of the same first equal-height bracket section. on the film, or the two said windows are circumferentially located on the main body covering film of the different first equal-height bracket segments; or the two said windows are circumferentially located on the main body covering covering the second height stent segment The main body of the stent segment is covered with film.
  12. 如权利要求9所述的覆膜支架,其特征在于,所述内嵌分支结构为轴向贯通的管状结构,其具有第一开口和第二开口,所述内嵌分支结构的第一开口和第二开口处均设有第一定位环结构,所述窗口处设有第二定位环结构,所述第一开口处的第一定位环结构位于所述主体覆膜的外侧,所述第二开口处的第一定位环结构位于所述主体覆膜的内侧,所述第二定位环结构位于所述主体覆膜的外侧。The stent graft of claim 9, wherein the embedded branch structure is an axially penetrating tubular structure having a first opening and a second opening, and the first opening and the second opening of the embedded branch structure are The second openings are each provided with a first positioning ring structure, and the window is provided with a second positioning ring structure. The first positioning ring structure at the first opening is located outside the main body coating, and the second positioning ring structure is provided at the second opening. The first positioning ring structure at the opening is located inside the main body coating, and the second positioning ring structure is located outside the main body coating.
  13. 如权利要求12所述的覆膜支架,其特征在于,所述第二定位环结构和第一定位环结构均包括支撑丝和显影丝,所述支撑丝呈圆环状,所述显影丝缠绕在所述支撑丝上或所述显影丝和所述支撑丝平行设置。The stent graft of claim 12, wherein the second positioning ring structure and the first positioning ring structure each include a supporting wire and a developing wire, the supporting wire is annular, and the developing wire is wrapped around On the support wire or the developing wire and the support wire are arranged in parallel.
  14. 如权利要求9所述的覆膜支架,其特征在于,还包括束径结构,所述束径结构设置在所述主体支架与主体覆膜上,且所述束径结构包括束径线圈和缝合线圈,所述束径线圈沿周向环抱所述第二变高支架段和/或第一等高支架段,所述缝合线圈设置于所述第二变高支架段和/或第一等高支架段远端的顶点、近端的顶点或棱上。The stent graft according to claim 9, further comprising a beam diameter structure, the beam diameter structure is arranged on the main body stent and the main body coating, and the beam diameter structure includes a beam diameter coil and a suture. Coil, the beam diameter coil circumferentially surrounds the second variable height stent section and/or the first equal height stent section, and the suture coil is arranged on the second variable height stent section and/or the first equal height stent section On the distal apex, proximal apex or edge of the stent segment.
  15. 如权利要求14所述的覆膜支架,其特征在于,所述缝合线圈设置于所述棱上,每个所述棱上设置两个所述缝合线圈,两个所述缝合线圈与各自对应距离最近的顶点间的间距相等;或者,每个所述棱上设置一个所述缝合线圈,所述缝合线圈位于所述棱的中点上。The stent graft of claim 14, wherein the suture coils are arranged on the edges, and two suture coils are arranged on each edge, and the two suture coils are at corresponding distances from each other. The spacing between the nearest vertices is equal; or, one suture loop is provided on each edge, and the suture loop is located at the midpoint of the edge.
  16. 如权利要求9所述的覆膜支架,其特征在于,所述主体部还包括裸段,所述裸段的远端连接所述主体覆膜的近端,且所述裸段轴向上与所述主体支架的近端部分重叠。The stent graft of claim 9, wherein the main body further includes a bare section, the distal end of the bare section is connected to the proximal end of the main body graft, and the bare section is axially connected to The proximal end portions of the main body supports overlap.
  17. 如权利要求16所述的覆膜支架,其特征在于,所述裸段包括支架环和位于所述支架环近端的倒钩结构,所述倒钩结构包括倒钩和倒钩柄,所述倒钩柄的远端连接所述支架环,所述倒钩柄的近端连接所述倒钩的近端,所述倒钩的远端向远离所述支架环的轴线方向外翻,且所述倒钩与所述支架环的轴线的夹角为10°~70°。 The stent graft of claim 16, wherein the bare section includes a stent ring and a barb structure located at the proximal end of the stent ring, the barb structure includes a barb and a barb handle, The distal end of the barb handle is connected to the stent ring, the proximal end of the barb handle is connected to the proximal end of the barb, the distal end of the barb is everted away from the axis of the stent ring, and the The angle between the barb and the axis of the bracket ring is 10° to 70°.
  18. 如权利要求1所述的覆膜支架,其特征在于,还包括拼接部,所述拼接部拼接在所述主体部的远端,所述拼接部包括第一拼接部,所述第一拼接部的近端连接所述主体部的远端。The stent graft according to claim 1, further comprising a splicing part spliced at the distal end of the main body part, the splicing part including a first splicing part, the first splicing part The proximal end is connected to the distal end of the main body part.
  19. 如权利要求18所述的覆膜支架,其特征在于,所述拼接部还包括第二拼接部,所述第一拼接部的远端具有同侧分支和对侧分支,所述第二拼接部的近端连接所述同侧分支,并用于建立同侧髂动脉血流,所述对侧分支用于拼接后建立对侧髂动脉血流。 The stent graft of claim 18, wherein the splicing part further includes a second splicing part, the distal end of the first splicing part has an ipsilateral branch and a contralateral branch, and the second splicing part The proximal end is connected to the ipsilateral branch and is used to establish the ipsilateral iliac artery blood flow, and the contralateral branch is used to establish the contralateral iliac artery blood flow after splicing.
PCT/CN2023/088841 2022-05-18 2023-04-18 Covered stent WO2023221712A1 (en)

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