WO2019042201A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2019042201A1
WO2019042201A1 PCT/CN2018/101738 CN2018101738W WO2019042201A1 WO 2019042201 A1 WO2019042201 A1 WO 2019042201A1 CN 2018101738 W CN2018101738 W CN 2018101738W WO 2019042201 A1 WO2019042201 A1 WO 2019042201A1
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WO
WIPO (PCT)
Prior art keywords
corrugated
ring
stent graft
bracket
section
Prior art date
Application number
PCT/CN2018/101738
Other languages
English (en)
French (fr)
Inventor
刘彩萍
李�真
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to EP18852005.0A priority Critical patent/EP3677221A4/en
Priority to US16/640,868 priority patent/US11523893B2/en
Publication of WO2019042201A1 publication Critical patent/WO2019042201A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Definitions

  • the invention relates to the field of cardiovascular medical devices, in particular to a stent graft.
  • the technique of laparoscopic fenestration is generally adopted, which can not only isolate the diseased blood vessel but also maintain the smooth flow of the bifurcated blood vessel, but at present, the technique still has difficulty in positioning the bifurcation port and branching.
  • the problem of poor matching with the main body and poor angle adaptability after the connection bracket is placed, how to effectively connect the branch and the main body, and achieve the ideal effect of isolation and shunting parallel is the research direction of the technology.
  • the in-situ fenestration technology of the stent graft is a technique of first invading the main body of the membrane, then introducing a physical puncture or laser breakdown to punch the hole at the branching position, and then introducing the connecting bracket.
  • the technical theory is feasible. In actual operation, there are problems such as debris falling off during the opening process, difficulty in controlling the size of the hole, and formation of a thrombus during window opening.
  • the Chinese Patent No. CN203841852U proposes a window-side supporting stent-covered stent, that is, a transition section short branch 3 is pre-positioned in the main stent 1 to be opened, and a polymer flexible section is adjacent to the opening position. 5
  • the connection opening position is connected with the short branch, and the method can be positioned through the short branch 3 of the transition section, and the good connection can be achieved by the flexible section 5 of the polymer.
  • the stent graft can adjust the angle of the short branch to a certain extent, so that it can effectively avoid the risk of endoleak caused by the tight joint.
  • the flexible segment 5 of the polymer lacks the support of the metal stent and is placed in the stent graft, under the impact of blood flow, the risk of branch blood supply shortage due to branch closure may be caused, and the burden of self-healing of the patient is increased.
  • the flexible section 5 of the polymer in the patent is completely fixed to the main body bracket 1. When the branch bracket is externally connected, the adjustment angle of the branch bracket is limited.
  • the Chinese patent application with the publication number CN 102488575A provides an aortic fenestration bracket.
  • the patent opens the side window to the main stent covering portion without the metal skeleton, and introduces a small bracket with a metal skeleton support on the inner wall of the side window. 3.
  • the axis of the small bracket 3 is parallel to the axis of the main bracket 1, and the small bracket 3 functions to connect the main bracket 1 and the branch bracket 2.
  • the metal frame of the small bracket 3 itself has improved the radial supporting force of the small bracket 3, and can effectively fix the branch passage, but reduces the flexibility.
  • the branch holder 2 When the introduction of the branch holder 2 is connected to the small holder 3, the branch holder 2 is easily restricted at the junction with the small holder 3, especially for complex branch vessels having a large degree of curvature. Moreover, the compatibility of the branch bracket 2 and the small bracket 3 is poor, and there may be a risk of type I endoleak. In addition, there is a problem that the local stress of the connecting section is large and the branch vessel is pressed.
  • the technical problem to be solved by the present invention is that, in view of the defects of the prior art, a stent graft capable of effectively fixing an external branch bracket and having better flexibility is provided.
  • the technical solution adopted by the present invention to solve the technical problem is: constructing a laminated stent, comprising a tubular main bracket and a connecting bracket disposed in the main bracket, wherein the main bracket has an opening on the side wall thereof
  • the connecting bracket includes a fixing section connected to a sidewall of the main bracket and a free section connected to the fixing section, the fixing section and the free section each including a bracket and a coating covering the surface of the bracket An end of the free segment away from the fixed segment is connected to an edge of the opening, and a gap is provided between a side of the free segment adjacent to the sidewall of the main bracket and a sidewall of the main bracket.
  • the stent graft of the invention introduces a connecting bracket inside the main stent, and the fixed section and the free section of the connecting bracket are provided with a bracket, which ensures the radial and axial supporting force of the connecting bracket, and avoids the occurrence of blood flow impact pressure.
  • the risk of channel closure is not fixed to the side wall of the main bracket except that the two ends are connected to the fixed section and the opening edge of the main bracket, and the adjustment angle of the external connecting bracket in the connecting section can be effectively solved compared with the ordinary window opening bracket. problem. Therefore, the stent graft of the present invention can be applied to various complex and variable branch vessel configurations, and has the advantages of good universality and simple structure.
  • a corresponding number of connecting stents can be introduced. If the branch vessels have no lesions, the connecting stent only serves as a drainage function to prevent a series of complications caused by branch vessel closure; if the branches involve lesions, The external branch bracket is introduced into the branch break and used in conjunction with the connecting bracket to achieve an isolation effect for therapeutic purposes.
  • Figure 1 is a front elevational view of a preferred embodiment of a stent graft of the present invention
  • Figure 2 is a right side view of the stent graft of Figure 1 of the present invention.
  • Figure 3 is a front elevational view of another embodiment of a stent graft of the present invention.
  • Figure 4 is a front elevational view showing still another embodiment of a stent graft of the present invention.
  • Figure 5a is a front elevational view of still another embodiment of a stent graft of the present invention.
  • Figure 5b is a schematic view showing the structure of the stent graft of Figure 5a in cooperation with the branch stent;
  • Figure 5c is a front elevational view of still another embodiment of a stent graft of the present invention.
  • Figure 5d is a schematic view showing the structure of the stent graft of Figure 5c and the branch stent in an embodiment
  • Figure 5e is a schematic view showing the structure of the stent graft of Figure 5c in cooperation with the branch stent in another embodiment
  • Figure 6 is a plan view of an extension of the stent graft of Figure 5a of the present invention.
  • FIG. 7a-7d are structural schematic views of an extension of the stent graft shown in Fig. 5a of the present invention.
  • Figure 8 is a front elevational view showing still another embodiment of a stent graft of the present invention.
  • Figure 9 is a schematic view showing the structure of the connecting bracket in the stent graft of Figure 1 of the present invention.
  • Figure 10 is a development view of a first embodiment of the stent of the free segment of the stent graft of Figure 1;
  • Figure 11 is an enlarged view of a portion A of Figure 10;
  • Figure 12 is a development view of a second embodiment of the stent of the free segment of the stent graft of Figure 1;
  • Figure 13 is an enlarged view of a portion B of Figure 12 of the present invention.
  • Figure 14 is a development view of a third embodiment of the stent of the free segment of the stent graft of Figure 1;
  • Figure 15 is a development view of a fourth embodiment of the stent of the free segment of the stent graft of Figure 1;
  • Figure 16 is a development view of a fifth embodiment of the stent of the free segment of the stent graft of Figure 1;
  • Figure 17 is a development view of a sixth embodiment of the stent of the free section of the stent graft of Figure 1;
  • Figure 18 is an enlarged view of a portion C of Figure 17 of the present invention.
  • Fig. 19 is a view showing the effect of the stent graft of the present invention after being implanted into the aortic arch and its branch vessels.
  • a stent graft 10 includes a tubular main stent 11 and a connecting bracket 12 disposed on the main stent 11 and connected to the main stent 11.
  • the side wall of the main bracket 11 is provided with an opening O.
  • the connecting bracket 12 includes a fixing section 121 connected to the side wall of the main bracket 11 and a free section 122 connected to the fixing section 121.
  • One end of the free section 122 away from the fixed section 121 is connected to the edge of the opening O, and a gap 123 is provided between the side of the free section 122 adjacent to the side wall of the main bracket 11 and the side wall of the main bracket 11.
  • the stent graft 10 has a radial expansion capability, can be compressed under an external force and self-expands after the external force is withdrawn or restored to the original shape by mechanical expansion (for example, balloon expansion and expansion), thereby maintaining the initial shape, thereby implanting the tube
  • the cavity can be fixed in the lumen by its radial supporting force against the wall of the lumen, thereby functioning to reconstruct the blood flow channel and isolate the lesion.
  • the connecting bracket 12 is entirely located inside the lumen of the main bracket 11, and the fixing section 121 is fixed to the inner side wall of the main bracket 11, which has a connecting line L with the inner side wall of the main bracket 11.
  • the proximal end of the free section 122 is connected to the fixed section 121, and the distal end thereof is connected to the edge of the opening O penetrating through the inner and outer side walls of the main bracket 11.
  • a gap 123 is provided between the side of the free section 122 near the inner side wall of the main bracket 11 and the inner side wall of the main bracket 11.
  • the center of the opening O falls on the extension line of the connecting line L of the fixed section 121 and the inner side wall of the main bracket 11.
  • the center of the opening O' may also be offset from the connecting line L' of the fixed section 121 and the inner side wall of the main bracket 11.
  • a part of the blood flowing into the lumen of the main stent 11 flows out through the connection bracket 12 from the opening O, and the blood flowing out from the opening O supplies blood to the branch blood vessel via the external stent.
  • the position of the center of the opening O relative to the connecting line L can not only control the blood flow rate flowing through the connecting bracket 12, but also achieve the blood pressure fine-tuning effect to match the normal branching blood flow velocity, and when the branch blood vessel is close to the distance, In this way, the implantation difficulties caused by the overlap of the two connecting brackets 12 can be avoided.
  • the opening O may be located between the coils of the main bracket 11 or on the coil of the main bracket 11 .
  • the opening O may be located on the coil of the main bracket 11, and the two branch brackets are respectively located on both sides of the coil of the main bracket 11.
  • the opening O is located between the main support coils, there is a morphological difference between the gaps in the gap between the coils.
  • the binding force to the branch brackets 5 is different, and the macroscopic branches are different.
  • the bracket 5 will exhibit different bending angles, indicating that the flexibility of the branch bracket 5 can be fine-tuned by changing the position of the opening O at this time.
  • the number of fixed segments 121 and free segments 122 are equal. It should be noted that, in another embodiment, the number of free segments 122 may be more than the number of fixed segments 121, and at least one fixed segment 121 is connected to the plurality of free segments 122. This structure may be used for slower blood flow rate, branching. More and different branch openings can be flexibly applied to subject vascular lesions involving multiple branches.
  • the fixed section 121 is one
  • the free section 122 is two
  • the fixed section 121 and the inner side wall of the main bracket 11 have a connecting line L1, an opening O1 and an opening O2. They are respectively located on both sides of the extension line of the connection line L1.
  • the attachment bracket 12 further includes an extension 129 that is coupled to an end of the free section 122 that is remote from the fixed section 121 and that extends beyond the main bracket 11 ( As shown in Figure 5a) or inside the main bracket (as shown in Figure 5c).
  • the branch bracket 5 can enter the free section 122 through the opening of the extending section 129 and the main bracket 11, and the actual effect is as shown in FIG. 5b.
  • the diameter of the connecting bracket 12 is small or the length of the free segment 122 is short, and the length of the extending portion 129 can be appropriately extended to increase the anchoring area of the branching bracket 5 to increase the anchoring force, and if the tumor cavity of the lesion is small, the diameter can be appropriately reduced.
  • the length of the extension section 129 can be set according to the actual situation of the patient.
  • the branch bracket 5 can pass through the fixed section 121 and the junction of the fixed section 121 and the free section 122 into the free section 122. The actual effect is shown in FIG. 5d.
  • the length of the fixed section 121 can be appropriately reduced.
  • the extension 129 acts only as a branch shunt at this time, and the length of the extension 129 can be appropriately reduced, and the extension 129 can be eliminated.
  • the branch bracket 5 can be directly passed through the connecting bracket 12, and the effect diagram is shown in Fig. 5e. The effect is similar to that of the chimney bracket, and the specific situation can be set according to the actual situation of the patient.
  • connection port of the branch bracket 5 is located at the opening of the free section or the extension section, and the length of the fixed section 121, the free section 122 and the extension section 123 can be adjusted according to the design, indicating that the design Can be applied to all kinds of complex branch bypass.
  • the end of the extending section 129 away from the free section 122 is provided with a developing mark 1291 , and the position of the end of the connecting bracket 12 can be accurately determined by setting the developing mark 1291, so that the doctor can connect the connecting bracket 12 .
  • the number and shape of the development marks 1291 can be adjusted according to actual conditions.
  • the extension section 129 may have a plurality of shapes. As shown in FIGS. 7a to 7d, the extension section 129 may be a cylindrical type having the same size at both ends (as shown in FIG. 7a), and the extension section 129 may also be a circular table having different sizes at both ends. Type (as shown in FIG.
  • the extension 129 can also be an hourglass type with the same size at both ends and gradually decreasing from the both ends to the intermediate position (as shown in FIG. 7c), and the extension 129 can also be the center line at both ends. Angles that are not on the same line (as shown in Figure 7d). It can be understood that FIGS. 7a-7d are only examples of the shape of the extension section 129, and are not intended to limit the invention. Those skilled in the art can adjust the shape of the extension section 129 according to actual conditions.
  • extension section 129 can also be provided with a self-expanding or ball-expanding metal skeleton, and the length of the extension section 129 can be adjusted according to actual needs.
  • the connecting bracket 12 is integrally located outside the lumen of the main bracket 11 , the fixing section 121 is fixed on the outer sidewall of the main bracket 11 , and one end of the free section 122 is connected to the fixing section 121 .
  • the other end is connected to the edge of the opening O of the main bracket 11, and a gap 123 is provided between the side of the free section 122 adjacent to the outer side wall of the main bracket 11 and the outer side wall of the main bracket 11, and the opening direction of the connecting bracket 12 is adjustable.
  • Both the fixed section 121 and the free section 122 of the present invention comprise a stent and a coating covering the surface of the stent.
  • the bracket of the fixed section 121 can effectively exert the radial and axial support functions, and the fixed section 121 has one side integrally connected with the side wall of the main bracket 11 to thereby stabilize the passage of the fixed section 121 and prevent the fixed section 121 channel. Closed under blood flow impact pressure.
  • the length a of the film of the free section 122 away from the side wall of the main bracket 11 is greater than the shortest vertical distance b from the proximal end to the distal end (as shown in FIG.
  • this configuration not only allows the free section 122 to be axially stretched, but also provides radial support for the film of the free section 122 to avoid passage of the free section 122.
  • the proximal end of the external branch bracket is in the free section 122, because the free section 122 is provided with a gap 123 between the side of the main bracket 11 and the side wall of the main bracket 11, so when the external branch is When the angle of the bracket needs to be adjusted, the gap 123 between the free section 122 and the main bracket 11 can provide space for the angle adjustment of the external branch bracket.
  • the diameter of the free section 122 is greater than the diameter of the fixed section 121.
  • the present invention further improves the stent structure of the free segment 122, which is specifically illustrated by several embodiments:
  • the bracket 124 of the free section 122 includes a plurality of corrugated loops 1241 spaced along its bus bars.
  • the waveforms of the plurality of corrugated loops 1241 are of the same phase. In other possible embodiments, the waveform phases of the plurality of waveform loops may also be reversed.
  • a plurality of corrugated annulites 1241 are joined to the lamination of the free section 122 by sutures or strip-like coatings 1242 only at their peaks and/or troughs.
  • the advantage of being connected to the membrane only at the location of the peaks and/or troughs is that both free passage closure and maximum flexibility of the free section 122 are avoided, since the stent 124 and the membrane are minimized.
  • the number of joints, when the free section is axially compressed, the film can be compressed to the maximum extent and the shape is changed to freedom.
  • Not all peaks and troughs are connected to the membrane, and several peaks and/or troughs can be selectively attached to the membrane.
  • the plurality of corrugated rings 1241 are spaced apart and have the same phase of the waveform. When subjected to the axial compressive force, the peak of one of the corrugated rings 1241 can extend into the middle of the two troughs of the corrugated ring adjacent thereto. Thereby increasing the flexibility of the free segment 122.
  • the bracket 125 of the free segment 122 includes a plurality of corrugated loops 1251, and the waveforms of the adjacent two corrugated loops 1251 are opposite in phase, and the peaks and troughs of the adjacent two corrugated loops 1251 are Interlock settings.
  • the interlock setting mentioned in the present invention refers to the structure shown in FIG. 13, and the second waveform ring 1251 in FIG. 7 forms the peak portion of the wire from the first waveform ring 1251 in FIG. The wire forming the trough portion passes over and then passes under the wire forming the trough portion.
  • the number of fixed points can be reduced, and the interlocking structure makes the adjacent two corrugated rings 1251
  • the axial expansion and fine adjustment can be easily combined with various complicated external branch brackets to improve the flexibility of the free section 122.
  • the radial support can be controlled and the local local fine adjustment can be achieved.
  • the peaks or troughs of the two waveform rings 1251 can be fixed only by the suture or the strip film; as shown in FIG. 14, when the free segment 122 is compared
  • the corrugated ring 1251 of the bracket 125 is increased, the crest or trough of the two corrugated rings 1251 at the beginning and the end is fixed, and the risk of the intermediate portion of the corrugated ring is lifted off the film. Therefore, it is preferable to One or more of the corrugated rings located between the first and last two corrugated rings 1251 are fixed to the crests or troughs by sutures and the film.
  • the adjacent two waveform loops are interlocked, and the bracket 126 of the free segment in the embodiment includes a first waveform ring 1261 and a second waveform.
  • the third waveform loop 1263 has a unequal height waveform.
  • the third waveform ring 1263 includes a plurality of first peaks 1263a adjacent to the first waveform ring 1261 and a plurality of second peaks 1263b away from the first waveform annulus 1261, the first peak 1263a and the second peak. 1263b is disposed along the circumferential spacing of the third undulating annulus 1263.
  • apex of all the first peaks 1263a falls on a plane perpendicular to the axis of the third undulating ring 1263
  • the apex of all the second peaks 1263b falls on another plane perpendicular to the axis of the third undulating ring 1263 on. All valley vertices of the third undulating annulus 1263 fall on the same plane perpendicular to their axes.
  • a second peak 1263b is disposed between any two adjacent first peaks 1263a. As shown in FIG. 16, two first levels can be set between any two adjacent first peaks 1263a'. Two peaks 1263b'. That is, the wave height of the third waveform ring 1263 changes periodically.
  • first peak 1263a is interlocked with the trough of the first corrugated ring 1261, and the trough of the third corrugated ring 1263 and the peak of the second corrugated ring 1262 are interlocked.
  • the third wave-shaped annulus 1263 has more wave numbers than the first wave-shaped annulus 1261 and the second wave-shaped annulus 1262 adjacent thereto, and the number of waves is increased while utilizing the interlocking structure to improve flexibility. The contact area between the stent and the film is increased, so that the adhesion is better.
  • the stent 127 of the free segment in this embodiment still includes a plurality of corrugated loops 1271, and the waveforms of any adjacent two corrugated loops are opposite in phase.
  • the crests or troughs of one of the corrugated rings 1271 are placed over the troughs or peaks of the other corrugated ring and are coated with the film.
  • the peak of the second corrugated ring 1271 is placed over the trough of the first corrugated ring 1271 and connected to the film by a suture.
  • Fig. 19 is a view showing the effect of the stent graft 10 of the embodiment of the present invention applied to the aortic arch 7 and its branches 701, 702 and 703, and the renal artery 6 and its branches 601 and 602.
  • the branch vessel has no lesions (such as 701 and 702)
  • the connecting stent 12 only acts as a drainage to prevent a series of complications caused by branch vessel closure; if the branch involves lesions (such as 703, 601, and 602), it can be broken at the branch.
  • the external branch bracket is introduced (the external bracket 5 is introduced in the branch 703 in FIG. 19), and the joint effect is used in conjunction with the joint bracket 12 to achieve the therapeutic purpose.
  • the stent graft of the invention introduces a connecting bracket on the main bracket, and the fixed section and the free section of the connecting bracket are provided with a bracket, which ensures the radial and axial supporting force of the connecting bracket, and avoids the occurrence of blood flow impact pressure.
  • the risk of channel closure is not fixed to the inner side wall of the main bracket except that the two ends are connected to the fixed section and the edge of the opening of the main bracket.
  • the adjustment angle of the external connecting bracket in the connecting section is limited. The problem. Therefore, the stent graft of the present invention can be applied to various complex and variable branch vessel configurations, and has the advantages of good universality and simple structure.

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Abstract

一种覆膜支架(10)，包括管状的主支架(11)和设于主支架(11)的连接支架(12)，主支架(11)的侧壁上设有开口，连接支架(12)包括与主支架(11)的侧壁相连的固定段(121)以及与固定段(121)相连的游离段(122)，固定段(121)和游离段(122)均包括支架和包覆于支架表面的覆膜，游离段(122)远离固定段(121)的一端与开口的边缘相连，且游离段(122)靠近主支架(11)侧壁的一侧与主支架(11)的侧壁之间设有间隙(123)。该覆膜支架(10)相比于普通内置式开窗支架能有效解决外接连接支架在连接段的调整角度受限的问题，且柔顺性更好。

Description

覆膜支架 技术领域
本发明涉及心血管医疗器械领域，尤其涉及一种覆膜支架。
背景技术
现有技术为解决病变部位累及分叉血管时一般采用覆膜支架开窗技术，该技术既能隔绝病变血管又能保持分叉血管的畅通，但目前该技术仍然存在分叉口定位困难、分支与主体衔接匹配性差、连接支架放置后角度适应性差等问题，如何有效的连接分支与主体，达到隔绝与分流并行的理想效果是该技术的研究方向。
覆膜支架原位开窗技术是一种先抵入完整的覆膜主体，后引入物理穿刺或激光击穿的方式在分支位置打孔，后引入连接支架的技术。该技术理论可行，实际操作中存在开孔过程中碎屑脱落、孔洞大小难以控制、开窗过程中可能形成血栓等问题。
针对以上问题，公告号为CN203841852U的中国专利提出一种开窗侧支型覆膜支架，即在主体支架1内部待开口位置预先置入一段过渡段短分支3，邻近开口位置用高分子柔性段5连接开口位置，与短分支相衔接，该方法既可通过过渡段短分支3定位，又可通过高分子柔性段5实现良好衔接。相对于只有刚性内置过渡段短分支的覆膜支架，该覆膜支架因其能在一定范围调节与短分支衔接的角度，使其能有效避免连接部位不紧密带来的内漏风险。但由于高分子柔性段5缺乏金属支架支撑，又置于覆膜支架内，在血流的冲击下可能会引起由于分支闭合导致的分支血供短缺的风险，增加了病人自愈的负担。此外，该专利中的高分子柔性段5完全固定于主体支架1，当外接分支支架时，分支支架的调整角度会受到一定的限制。
公告号为CN 102488575A的中国专利申请提供了一种主动脉开窗支架，该专利将侧窗开在不含金属骨架的主支架覆膜部位，并在侧窗内壁引入带金属骨 架支撑的小支架3，且小支架3的轴线与主支架1的轴线平行，小支架3的作用为连接主支架1和分支支架2。小支架3本身具有的金属骨架虽然提高了小支架3的径向支撑力，能有效固定分支通道，但却降低了其柔顺性。当引入分支支架2与小支架3连接，分支支架2在与小支架3连接处易受限制，尤其对于弯曲程度较大的复杂分支血管。且分支支架2与小支架3的兼容性较差，可能存在Ⅰ型内漏的风险，此外还存在连接段局部应力偏大，压迫分支血管的问题。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种能有效固定外接分支支架且具有较好柔顺性的覆膜支架。
本发明解决其技术问题所采用的技术方案是：构造一种覆膜支架，包括管状的主支架和设于所述主支架内的连接支架，所述主支架的侧壁上设有开口，所述连接支架包括与所述主支架的侧壁相连的固定段以及与所述固定段相连的游离段，所述固定段和所述游离段均包括支架和包覆于所述支架表面的覆膜，所述游离段远离所述固定段的一端与所述开口的边缘相连，且所述游离段靠近所述主支架侧壁的一侧与所述主支架的侧壁之间设有间隙。
本发明的覆膜支架在主支架内部引入连接支架，连接支架的固定段和游离段均设有支架，保证了连接支架在径向和轴向的支撑力，避免了由于血流冲击压力而发生通道关闭的风险。此外，游离段除了两端连接固定段和主支架开口边缘外，中间部位未固定到主支架的侧壁，相比于普通开窗支架能有效解决外接连接支架在连接段的调整角度受限的问题。因此，本发明的覆膜支架能够适用于各种复杂多变的分支血管构型，具有普适性好、结构简单等优点。
此外还可根据具体病变部位的分支血管数量，引入相应数量的连接支架，若分支血管无病变，该连接支架只充当引流的作用，防止分支血管封闭引起的系列并发症；若分支累及病变，可在分支破口引入外接分支支架，与连接支架配合使用发挥隔绝效果，达到治疗目的。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明一种覆膜支架优选实施例的主视图；
图2是本发明图1所示覆膜支架的右视图；
图3是本发明一种覆膜支架另一实施例的主视图；
图4是本发明一种覆膜支架又一实施例的主视图；
图5a是本发明一种覆膜支架又一实施例的主视图；
图5b是图5a的覆膜支架与分支支架配合的结构示意图；
图5c是本发明一种覆膜支架又一实施例的主视图；
图5d是一实施例中图5c的覆膜支架与分支支架配合的结构示意图；
图5e是另一实施例中图5c的覆膜支架与分支支架配合的结构示意图；
图6是本发明图5a所示的覆膜支架的延伸段的俯视图；
图7a～7d分别是本发明图5a所示的覆膜支架的延伸段的结构示意图；
图8为本发明一种覆膜支架又一实施例的主视图；
图9是本发明图1所示覆膜支架中连接支架的结构示意图；
图10是本发明图1所示覆膜支架中游离段的支架第一实施例的展开图；
图11是图10中A部位的放大图；
图12是本发明图1所示覆膜支架中游离段的支架第二实施例的展开图；
图13是本发明图12中B部位的放大图；
图14是本发明图1中所示覆膜支架中游离段的支架第三实施例的展开图；
图15是本发明图1中所示覆膜支架中游离段的支架第四实施例的展开图；
图16是本发明图1中所示覆膜支架中游离段的支架第五实施例的展开图；
图17是本发明图1中所示覆膜支架中游离段的支架第六实施例的展开图；
图18是本发明图17中C部位的放大图；
图19是本发明的覆膜支架被植入主动脉弓及其分支血管后的效果示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
如图1和图8所示，一种覆膜支架10包括管状的主支架11和设于主支架11并与主支架11相连的连接支架12。主支架11的侧壁开设有开口O，连接支架12包括与主支架11的侧壁相连的固定段121以及与固定段121相连的游离段122。游离段122远离固定段121的一端与开口O的边缘相连，且游离段122靠近主支架11侧壁的一侧与主支架11侧壁之间设有间隙123。该覆膜支架10具有径向膨胀能力，可在外力作用下被压缩并在外力撤销后自膨胀或通过机械膨胀(例如球囊扩张膨胀)恢复至初始形状并保持初始形状，由此植入管腔后可通过其径向支撑力紧贴管腔壁而固定于管腔内，从而起到重建血流通道，隔绝病灶的作用。
如图1和图2所示，连接支架12整体位于主支架11的管腔内部，固定段121固定在主支架11的内侧壁上，其与主支架11的内侧壁具有连接线L。游离段122的近端与固定段121相连，其远端与贯通主支架11内、外侧壁上的开口O的边缘相连。且游离段122靠近主支架11内侧壁的一侧与主支架11的内侧壁之间设有间隙123。在本实施例中，开口O的中心落在固定段121与主支架11内侧壁的连接线L的延长线上。如图3所示，在另一实施例中，开口O’的中心也可以偏离固定段121与主支架11内侧壁的连接线L’。流入主支架11管腔中的血液一部分会通过连接支架12自开口O流出，自开口O流出的血液会经由外接支架给分支血管供血。开口O的中心相对于连接线L的位置不仅可实现对流经连接支架12的血液流速进行控制从而达到血压微调效果，使之与正常分支血管流速相匹配，而且当分支血管距离紧挨时，亦可通过此种方式避免两连接支架12重叠带来的植入困难。具体可根据患者实际病情进行设定，最后应既可保证连接支架12内有血流通过，又可控制连接支架12内的血流速度。需要说明的是，开口O可以位于主支架11的波圈间，也可以位于主支架11的波圈上。例如，当开口O与两个分支支架连接时，开口O可以位于主支架11的波圈上，两个分支支架分别位于主支架11此波圈的两侧。当开口O位于主支架波圈间时，因波圈间覆膜空白区域存在形态差异，此时 不同位置开口O若连接分支支架5，其对分支支架5的束缚力是不同的，宏观上分支支架5将表现出不同弯曲角度，说明此时通过改变开口O位置，可对分支支架5柔顺性进行微调。
在图1至图3所示的实施例中，固定段121与游离段122的数量相等。需要说明的是，在另一实施例中，游离段122的数量可以多于固定段121的数量，至少一固定段121与多个游离段122连接，此结构可用于血流速率较慢，分支较多且方位不一的分支开口，可灵活应用于累及多分支的主体血管病变。具体的，如图4所示，固定段121为1个，游离段122为两个，且具有开口O1及开口O2，固定段121与主支架11内侧壁具有连接线L1，开口O1及开口O2分别位于连接线L1的延长线的两侧。
如图5a和5c所示，在其中一个实施例中，连接支架12还包括延伸段129，延伸段129与游离段122远离固定段121的一端连接，且延伸段129伸出主支架11外(如图5a所示)或位于主支架内部(如图5c所示)。在其中一个实施例中，当连接支架12内置时如图5a所示，分支支架5可穿过延伸段129及主支架11的开口进入游离段122，实际效果如图5b所示，此时若连接支架12直径较小或游离段122的长度较短，可适当延长延伸段129的长度，以增加分支支架5的锚定区域提高其锚定力，若病变部位瘤腔较小时，可适当减少延伸段129的长度，具体情况可以依病人实际情况设定。在另一实施例中，当连接支架12外置时如图5c所示，分支支架5可穿过固定段121及固定段121与游离段122的连接处进入游离段122，实际效果如图5d所示，此时若瘤体轴向延伸区域较短，可适当减少固定段121的长度，延伸段129此时只是充当分支分流作用，可适当减少延伸段129的长度，甚至可以取消延伸段129。若瘤腔体积进一步减小，可直接将分支支架5穿过连接支架12，效果图如图5e所示，此时效果与烟囱支架相仿，具体情况可以依病人实际情况设定。需要指出的是以上两种情况分支支架5连接端口位于游离段或延伸段开口其角度可调，此外固定段121、游离段122及延伸段123的三者长度可依设计进行调整，说明该设计能适用于各类复杂分支旁路。
进一步的请一并参阅图6，延伸段129远离所述游离段122的一端设置有 显影标记1291，通过设置显影标记1291可以准确判断连接支架12的端部位置，方便医生在连接支架12上接入分支支架5。显影标记1291的数量和形状可以根据实际情况进行调整设计。延伸段129的形状可以为多种，如图7a～7d所示，延伸段129可以为两端大小相同的圆柱型(如图7a所示)，延伸段129还可以为两端大小不同的圆台型(如图7b所示)，延伸段129还可以为两端大小相同且从两端向中间位置逐渐减小的沙漏型(如图7c所示)，延伸段129还可以为两端中心线不在同一直线上的角型(如图7d所示)。可以理解的是，图7a～7d仅为延伸段129的形状的举例说明，并不是对本发明的限制，本领域技术人员可以根据实际情况，调整延伸段129的形状。
还可以理解的是，延伸段129表面还可以设置有自膨胀式或球扩式金属骨架，且延伸段129的长度可以根据实际需要进行调整。
如图8所示，本发明另一实施例中，连接支架12整体位于主支架11的管腔外侧，固定段121固定在主支架11的外侧壁上，游离段122一端与固定段121连接，另一端与主支架11的开口O的边缘连接，且游离段122靠近主支架11外侧壁的一侧与主支架11的外侧壁之间设有间隙123，另外连接支架12的开口方向可调。
本发明的固定段121与游离段122均包括支架和包覆于支架表面的覆膜。固定段121的支架能有效发挥出径向和轴向支撑作用，再加之固定段121有一侧整体与主支架11的侧壁相连，从而起到稳定固定段121通道的效果，防止固定段121通道在血流冲击压力下闭合。在装配状态下,游离段122远离主支架11侧壁一侧的覆膜长度a大于其近端到远端的最短垂直距离b(如图9所示)，且游离段122的支架波圈间有间隙，这种结构不仅能使游离段122轴向部分伸缩，同时可为游离段122的覆膜提供径向支撑以避免游离段122的通道闭合。此外，当外接分支支架时，外接分支支架的近端处在游离段122内，因为游离段122靠近主支架11的一侧与主支架11的侧壁之间设有间隙123，因此当外接分支支架的角度需要调整时，游离段122与主支架11之间的间隙123能给外接分支支架的角度调整提供空间。在其中一个实施例中，游离段122的直径大于固定段121的直径。当分支支架接入到游离段122后，通过增加游离段122 的直径，可以在保证主支架11血流量不变的情况下，增加分支支架血流流通截面，此外，当分支支架的直径较大时，也可以在不影响主支架11所需的鞘管直径下，较好的与分支支架吻合，减少内漏的发生。
为进一步提高游离段122的柔顺性，本发明对游离段122的支架结构做了进一步改进，下面通过几个实施例来具体说明：
第一实施例：
如图10所示，游离段122的支架124包括多个沿其母线间隔设置的波形环状物1241，在本实施例中，多个波形环状物1241的波形相位相同。在其他可能的实施例中，多个波形环状物的波形相位也可以相反。如图11所示，多个波形环状物1241仅在其波峰和/或波谷位置通过缝线或带状覆膜1242与游离段122的覆膜相连。仅在波峰和/或波谷的位置与覆膜相连的优点在于既可避免游离段通道闭合，又能最大限度地保持游离段122的柔顺性,这是因为最大限度地减少了支架124与覆膜的连接点数量，在游离段被轴向压缩时，覆膜可以最大限度地被压缩，形变更为自由。并不是所有波峰和波谷都要与覆膜相连，可以选择性地将几个波峰和/或波谷与覆膜相连。多个波形环状物1241间隔设置且波形相位相同，在受到轴向的压缩力时，其中一个波形环状物1241的波峰能够伸入到与之相邻的波形环状物的两个波谷中间，从而提高游离段122的柔顺性。
第二实施例：
如图12所示，游离段122的支架125包括多个波形环状物1251，相邻两个波形环状物1251的波形相位相反，且相邻两个波形环状物1251的波峰和波谷呈互锁设置。本发明中提及的互锁设置指的是如图13所示的结构，图7中第二个波形环状物1251形成波峰部分的金属丝先从图12中第一个波形环状物1251形成波谷部分的金属丝上方越过，然后再自形成波谷部分的金属丝下方穿出。通过这种互锁的结构将相邻两个波形环状物相连，而不是通过缝线相连，能够减少固定点的数量，而且这种互锁的结构使得相邻两个波形环状物1251之间可轴向伸缩微调，便于与各类复杂的外接分支支架契合，提高了游离段122的柔顺性。另外还可通过设定波形环状物的数量及间距，以及调整波形环 状物的丝径、波数及高度，既可以达到径向支撑可控，又可实现轴向局部微调的效果。
此外，当支架125的波形环状物1251数量不多时，可仅通过缝线或带状覆膜固定首尾两个波形环状物1251的波峰或波谷；如图14所示，当游离段122较长，支架125的波形环状物1251随之增多时，则仅仅在首尾两个波形环状物1251的波峰或波谷固定恐有中间部分的波形环状物翘离覆膜的风险，因此宜在位于首尾两个波形环状物1251之间的波形环状物中择出一个或几个对其波峰或波谷通过缝线与覆膜固定。
第三实施例：
如图15所示，在上一实施例中任意相邻两个波形环状物呈互锁设置的基础上，本实施例中游离段的支架126包括第一波形环状物1261、第二波形环状物1262以及位于第一波形环状物1261和第二波形环状物1262之间的第三波形环状物1263。第三波形环状物1263具有不等高波形。其中，第三波形环状物1263包括多个靠近第一波形环状物1261的第一波峰1263a以及多个远离第一波形环状物1261的第二波峰1263b，第一波峰1263a和第二波峰1263b沿第三波形环状物1263的周向间隔设置。且所有第一波峰1263a的顶点落在与第三波形环状物1263的轴线垂直的平面上，而所有第二波峰1263b的顶点落在与第三波形环状物1263的轴线垂直的另一平面上。第三波形环状物1263的所有波谷顶点落在垂直与其轴线的同一个平面上。在本实施例中，任意相邻两个第一波峰1263a之间设有一个第二波峰1263b，如图16所示，在任意相邻两个第一波峰1263a’之间也可以设置两个第二波峰1263b’。即第三波形环状物1263的波高呈周期性变化。进一步的，第一波峰1263a与第一波形环状物1261的波谷呈互锁设置，第三波形环状物1263的波谷与第二波形环状物1262的波峰呈互锁设置。第三波形环状物1263相对于与之相邻的第一波形环状物1261和第二波形环状物1262具有更多的波数，在利用互锁结构提高柔顺性的同时，更多的波数增加了支架与覆膜之间的接触面积，因此贴壁性更好。
第四实施例：
如图17和图18所示，本实施例中的游离段的支架127仍然包括多个波形 环状物1271，任意相邻两个波形环状物的波形相位相反。与上一实施例不同的是，任意相邻两个波形环状物1271中，其中一个波形环状物1271的波峰或波谷搭设于另一个波形环状物的波谷或波峰之上并与覆膜相连。图12所示的是第二个波形环状物1271的波峰搭设于第一个波形环状物1271的波谷之上并与覆膜通过缝线相连。
如图17所示，在以固定点D1为中心的圆形区域内，分布有另外四个固定点D2、D3、D4和D5。其中固定点D1、D2、D3所在的波形在游离段被压缩时，其运动仅仅受到来自于前述五个固定点的限制，可在固定点D1、D4和D5所在的波形的波高范围内活动，因此较之上述实施例，其柔顺性更好。
图19给出了本发明一实施例的覆膜支架10被应用到主动脉弓7及其分支701、702和703中，以及肾动脉6及其分支601和602中的效果示意图。若分支血管无病变(如701和702)，该连接支架12只充当引流的作用，防止分支血管封闭引起的系列并发症；若分支累及病变(如703、601和602)，可在分支破口引入外接分支支架(图19中示出了在分支703中引入了外接支架5)，与连接支架12配合使用发挥隔绝效果，达到治疗目的。
本发明的覆膜支架在主支架上引入连接支架，连接支架的固定段和游离段均设有支架，保证了连接支架在径向和轴向的支撑力，避免了由于血流冲击压力而发生通道关闭的风险。此外，游离段除了两端连接固定段和主支架开口边缘外，中间部位未固定到主支架内侧壁，相比于普通内置式开窗支架能有效解决外接连接支架在连接段的调整角度受限的问题。因此，本发明覆膜支架能够适用于各种复杂多变的分支血管构型，具有普适性好、结构简单等优点。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (19)

  1. 一种覆膜支架，包括管状的主支架和设于所述主支架的连接支架，所述主支架的侧壁上设有开口，其特征在于，所述连接支架包括与所述主支架的侧壁相连的固定段以及与所述固定段相连的游离段，所述固定段和所述游离段均包括支架和包覆于所述支架表面的覆膜，所述游离段远离所述固定段的一端与所述开口的边缘相连，且所述游离段靠近所述主支架侧壁的一侧与所述主支架的侧壁之间设有间隙。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述固定段固定在所述主支架的内侧壁上，所述游离段靠近所述主支架内侧壁的一侧与所述主支架的内侧壁之间设有所述间隙。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述连接支架还包括延伸段，所述延伸段与所述游离段远离所述固定段的一端连接，且所述延伸段伸出所述主支架外。
  4. 根据权利要求3所述的覆膜支架，其特征在于，所述延伸段远离所述游离段的一端设置有显影标记。
  5. 根据权利要求1所述的覆膜支架，其特征在于，所述固定段固定在所述主支架的外侧壁，且所述游离段靠近所述主支架外侧壁的一侧与所述主支架的外侧壁之间设有所述间隙。
  6. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述游离段的所述支架包括多个沿所述游离段的母线间隔设置的波形环状物，多个所述波形环状物仅在其波峰和/或波谷位置与所述游离段的覆膜相连。
  7. 根据权利要求6所述的覆膜支架，其特征在于，相邻两个所述波形环状物的相位相同或相反。
  8. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述游离段的所述支架包括多个波形环状物，任意相邻两个所述波形环状物的相位相反，且任意相邻两个所述波形环状物的波峰和波谷呈互锁设置。
  9. 根据权利要求8所述的覆膜支架，其特征在于，多个所述波形环状物中，至少首尾两个所述波形环状物的波峰或波谷与所述游离段的覆膜相连。
  10. 根据权利要求9所述的覆膜支架，其特征在于，多个所述波形环状物包括第一波形环状物、与所述第一波形环状物间隔设置的第二波形环状物以及设于所述第一波形环状物和所述第二波形环状物之间并与所述第一波形环状物和所述第二波形环状物相连的第三波形环状物；所述第三波形环状物具有不等高波形。
  11. 根据权利要求10所述的覆膜支架，其特征在于，所述第三波形环状物的波峰顶点包括较靠近所述第一波形环状物的第一波峰、和远离所述第一波形环状物的第二波峰，且所述第一波峰和所述第二波峰沿所述第三波形环状物的周向间隔设置并分别落在垂直于所述第三波形环状物轴线的两个平面上，所述第三波形环状物的波谷顶点落在垂直于所述第三波形环状物轴线的同一个平面上；
    所述靠近所述第一波形环状物的波峰与所述第一波形环状物的波谷呈互锁设置，所述第三波形环状物的波谷与所述第二波形环状物的波峰呈互锁设置。
  12. 根据权利要求11所述的覆膜支架，其特征在于，任意相邻两个第一波峰之间设有两个第二波峰。
  13. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述游离段的所述支架包括多个波形环状物，任意相邻两个所述波形环状物的相位相反，且其中一所述波形环状物的波峰或波谷搭设于另一所述波形环状物的波谷或波峰之上，且搭设于另一所述波形环状物之上的波峰或波谷与所述游离段的覆膜相连。
  14. 根据权利要求13所述的覆膜支架，其特征在于，多个所述波形环状物包括第一波形环状物、与所述第一波形环状物间隔设置的第二波形环状物以及设于所述第一波形环状物和所述第二波形环状物之间并与所述第一波形环状物和所述第二波形环状物相连的第三波形环状物；所述第三波形环状物具有不等高波形。
  15. 根据权利要求13所述的覆膜支架，其特征在于，所述第三波形环状物的波峰顶点包括较靠近所述第一波形环状物的第一波峰、和远离所述第一波 形环状物的第二波峰，且所述第一波峰和所述第二波峰沿所述第三波形环状物的周向间隔设置并分别落在垂直于所述第三波形环状物轴线的两个平面上，所述第三波形环状物的波谷顶点落在垂直于所述第三波形环状物轴线的同一个平面上；
    所述靠近所述第一波形环状物的波峰搭设于所述第一波形环状物的波谷上并与所述覆膜相连，所述第三波形环状物的波谷搭设于所述第二波形环状物的波峰上并于所述覆膜相连。
  16. 根据权利要求15所述的覆膜支架，其特征在于，任意相邻两个所述第一波峰之间设有两个第二波峰。
  17. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述开口的中心落在所述固定段与所述主支架连接线的延长线上。
  18. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述开口的中心偏离所述固定段与所述主支架连接线的延长线。
  19. 根据权利要求1～5任一项所述的覆膜支架，其特征在于，所述游离段的数量多于所述固定段的数量，至少一个所述固定段与多个所述游离段连接。
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