WO2023125547A1 - 一种覆膜支架 - Google Patents

一种覆膜支架 Download PDF

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Publication number
WO2023125547A1
WO2023125547A1 PCT/CN2022/142386 CN2022142386W WO2023125547A1 WO 2023125547 A1 WO2023125547 A1 WO 2023125547A1 CN 2022142386 W CN2022142386 W CN 2022142386W WO 2023125547 A1 WO2023125547 A1 WO 2023125547A1
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WO
WIPO (PCT)
Prior art keywords
wave
stent
coil
support
supporting
Prior art date
Application number
PCT/CN2022/142386
Other languages
English (en)
French (fr)
Inventor
舒畅
林志鹏
肖本好
明廷伯
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
Priority claimed from CN202111669298.1A external-priority patent/CN116407333A/zh
Priority claimed from CN202111669262.3A external-priority patent/CN116407331A/zh
Priority claimed from CN202111662163.2A external-priority patent/CN116407326A/zh
Priority claimed from CN202111669263.8A external-priority patent/CN116407332A/zh
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
Publication of WO2023125547A1 publication Critical patent/WO2023125547A1/zh

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

Definitions

  • the invention belongs to the technical field of medical devices, in particular to a covered stent.
  • Aortic aneurysm and aortic dissection are currently diseases that seriously endanger human life. If not actively treated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the continuous increase of patients with blood lipids and high diabetes, the incidence of aortic aneurysm and aortic dissection is also significantly increasing.
  • Traditional aortic covered stents generally expose bare stents made of memory metal alloys at the proximal end of the stent (the side close to the heart after the stent-graft is released), or set barbs on the outer wall of the stent, so that it can be used during surgery. And in the early postoperative period, the covered stent can be accurately placed in the artery, and the covered stent will not be withdrawn.
  • the above-mentioned bare stent and barbs will always remain in the artery, and over time, it will cause a certain degree of damage to the patient's artery, resulting in rupture of the aortic intima and media, and new aortic dissection.
  • the above method may damage the intima when the stent is released, causing the intima to rupture and form a new breach. Therefore, a new technical solution is needed to solve the above problems.
  • the purpose of the present invention is to at least solve the problem that the aortic intima is easily damaged by bare stents or barbs of the covered stent.
  • a stent graft including a main body support and a graft body disposed on the main support, wherein the main body support includes a main stent segment and a stent graft disposed on the main stent segment
  • the support frame section at the proximal end, the support frame section includes a connecting wave coil connected to the main body of the film graft, and the connecting wave coil includes several fixed wave sections fixedly connected to the film graft body and at least one The active waveform segments of the active connection of the covering body.
  • the problem that the aortic intima is easily damaged by the bare stent or barbs of the traditional stent graft can be avoided, the inner wall of the blood vessel in the anchoring area of the patient is protected, and the wall-attachment effect is better.
  • the fixed waveform segment and the active waveform segment are sequentially arranged at intervals.
  • the fixed wave segments include fixed crests, fixed troughs, and fixed rods connecting adjacent fixed crests and fixed troughs.
  • the proximal edge is flush;
  • the active waveform segment includes an active wave crest, an active wave trough, and an active wave rod connecting the adjacent active wave peaks and active wave troughs, the active wave trough is fixedly connected with the coating body, the active wave peak and the active wave
  • the rod is movably connected with the film covering body.
  • the movable probe is set at a preset angle with the coating body; or the movable probe includes a bent portion connected to the active peak, and the bent portion is connected to the active peak.
  • the film covering body is arranged at a preset angle.
  • the movable probe is bent toward the inner side of the film-coated body, or the bending portion is bent toward the inner side of the film-coated body, and the predetermined angle is greater than 0° and less than or equal to 45°, the percentage of the ratio of the length of the bent portion to the length of the movable wave rod is greater than or equal to 30% and less than or equal to 60%.
  • the supporting frame segment further includes a supporting corrugated coil disposed at the port of the supporting membrane, and a wire diameter of the supporting corrugated coil is smaller than a wire diameter of the connecting corrugated coil.
  • the number of bands of the supporting corrugated coil is greater than the number of bands of the connecting corrugated coil.
  • the supporting wave coil is fixedly connected to the coating body, or the supporting wave coil is fixedly connected to the connecting wave coil.
  • the proximal end of the supporting wave coil is flush with the proximal edge of the graft body, or the distal end of the supporting wave coil is flush with the distal edge of the connecting wave coil. aligned, or the supporting wave coil is arranged between the distal end of the connecting wave coil and the proximal end of the graft body.
  • the main body support is provided with a groove part that is recessed toward the inner side of the main body support, and the groove part includes a groove support connected to the main body support and a set Groove film on the groove support; a developer is provided on the main body support and/or the support film.
  • FIG. 1 is a schematic diagram of the overall structure of the stent graft in Embodiment 1 of the present invention
  • Figure 2 is a schematic structural view of a branch stent in Embodiment 1 of the present invention
  • FIG. 3 is a schematic structural view of the proximal part of the stent graft in Embodiment 1 of the present invention.
  • Example 4 is a schematic structural view of another embodiment of the proximal part of the stent graft in Example 1 of the present invention.
  • Fig. 5 is a schematic structural view of the wave coil of the main support in Embodiment 1 of the present invention.
  • Fig. 6 is a schematic structural diagram of connecting corrugated coils in Embodiment 1 of the present invention.
  • Fig. 7 is a schematic diagram of the connecting structure connecting the corrugated coil and the coating body in Embodiment 1 of the present invention.
  • Fig. 8 is a structural schematic diagram of the supporting wave coil in Embodiment 1 of the present invention.
  • FIG. 9 is a schematic structural view of the stent graft in a half-release state in Embodiment 1 of the present invention.
  • FIG. 10 is a schematic diagram of the connection structure between the delivery device and the stent-graft when the stent-graft is in a half-release state in Embodiment 1 of the present invention
  • Fig. 11 is a schematic structural view of another embodiment of the wave coil of the main support in Embodiment 1 of the present invention.
  • FIG. 12 is a schematic structural view of the stent graft in the sheath in Embodiment 1 of the present invention.
  • Fig. 13 is a cross-sectional view of the stent graft in the sheath in Embodiment 1 of the present invention.
  • Fig. 14 is a schematic diagram of the structure of the connecting corrugated coil and the supporting corrugated coil set with half a phase difference in Embodiment 1 of the present invention
  • Figure 15 is a schematic structural view of the developing strip in Embodiment 1 of the present invention.
  • Fig. 16 is a structural schematic view of another viewing angle of the developing strip in Embodiment 1 of the present invention.
  • Fig. 17 is a schematic structural view of the connecting rod in Embodiment 2 of the present invention.
  • Fig. 18 is a side view of connecting corrugated coils in Embodiment 3 of the present invention.
  • Fig. 19 is a front view of connecting corrugated coils in Embodiment 3 of the present invention.
  • Fig. 20 is a side view of connecting corrugated coils in Embodiment 4 of the present invention.
  • Fig. 21 is a front view of connecting corrugated coils in Embodiment 4 of the present invention.
  • Fig. 22 is a schematic structural view of the proximal part of the covered stent in Embodiment 5 of the present invention.
  • Fig. 23 is a schematic structural view of the proximal part of the stent-graft in Embodiment 6 of the present invention.
  • Fig. 24 is a schematic structural view of the proximal part of the covered stent in Embodiment 7 of the present invention.
  • Fig. 25 is a schematic structural view of the proximal part of the stent graft in Embodiment 8 of the present invention.
  • Fig. 26 is a schematic structural view of the developing part of the stent-graft in Embodiment 9 of the present invention.
  • FIG. 27 is a structural schematic diagram of another viewing angle of the developing part of the stent-graft in Embodiment 9 of the present invention.
  • 001 covered stent; 002, main support; 003, branch support; 100, main support; 200, main support section; 300, support frame section; 400, branch support; 401, branch wave coil; 402, branch connection Rod; 403, developing ring; 500, branch coating;
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as “inner”, “outer”, “inner”. “, “Outside”, “Below”, “Below”, “Above”, “Above”, etc.
  • Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” or “beneath” the other elements or features. feature above”. Thus, the example term “below” can encompass both an orientation of above and below.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • distal end refers to the end away from the heart
  • proximal end refers to the end near the heart
  • axial direction should be understood in this patent as the direction in which the interventional device is pushed and pushed out, and the direction perpendicular to the "axial direction” is defined as the "radial direction”.
  • the stent graft 001 of this embodiment is a hollow tubular structure with openings at both ends as a whole, including a main stent 002 and a branch stent 003, and the branch stent 003 is arranged on the side of the main stent 002.
  • the main body stent 002 is used for implanting in the aortic vessel
  • the branch stent 003 is used for implanting in the branch vessel.
  • the branch bracket 003 has a hollow cylindrical structure, and the branch bracket 003 is arranged along the length direction of the main body bracket 002 .
  • the axial direction of the branch bracket 003 is the same as that of the main body support 100 .
  • the branch bracket 003 is set at a preset angle with the main body support 100, and the preset angle can be 3°, 5° or 10°, etc., and is set according to actual needs.
  • the surface of the main body bracket 002 is provided with a groove part 50 that is sunken toward the inside of the main body bracket 002.
  • the edge of the groove part 50 is connected to the film body 10 of the main body bracket 002.
  • Groove coating 52 on trough support 51 is connected to the groove support 51 .
  • the groove support 51 is connected with the main body support 100
  • the groove coating 52 is connected with the coating body 10 .
  • the edge of the groove coating 52 is connected to the coating body 10 by sewing.
  • a sewing ring 53 is provided between the groove coating 52 and the coating body 10 , and the groove coating 52 and the coating body are connected by the sewing ring 53 .
  • a supporting ring (not shown in the figure) for strengthening the supporting strength of the groove portion 50 may be provided in the sewing ring 53 , and the supporting ring is an elastic metal ring.
  • the groove coating 52 can also be integrally formed with the coating body 10 , and the groove coating 52 is fixed on the groove support 51 by means of sewing or the like.
  • the groove support 51 is concave relative to the main body support 100 , and the groove support 51 is used to shape the groove coating 52 to form an overall concave groove portion 50 .
  • the groove coating 52 is provided with a through hole 521, and the branch bracket 003 communicates with the through hole 521, so that blood flows from the main body bracket 002 through the through hole 521 into the branch bracket 003, wherein the branch bracket 003 is fixedly connected by suturing in the through hole 521 .
  • the main body bracket 002 includes one or more branch brackets 003, and the diameters of the plurality of branch brackets 003 can be the same or different, and can be set according to actual needs.
  • the stent graft 001 includes three branch stents 003 , wherein two branch stents 003 are disposed near the proximal end of the groove portion 50 , and one branch stent 003 is disposed near the distal end of the groove portion 50 .
  • the branch stent 003 includes a branch support 400 and a branch coating 500 disposed on the branch support 400 , and the branch coating 500 is connected to the through hole 521 by suturing.
  • the outer edge of the through hole 521 is sutured with a developing ring 403 by a suture thread for displaying the position of the branch bracket 003 .
  • the branch support member 400 includes several branch wave coils 401 arranged at intervals, branch connecting rods 402 are arranged between adjacent branch wave coils 401, and the branch wave coils 401 are wave-shaped or diamond-shaped.
  • the coating body 10 is arranged on the main body support 100. It should be understood that the main body support 100 can be arranged on the inner surface of the coating body 10, or on the outer surface of the coating body 10, or a part of the main body support 100 It is arranged on the inner surface of the membrane main body 10 , and another part of the main body support 100 is arranged on the outer surface of the membrane main body 10 .
  • the length of the main body support 10 is greater than or equal to the length of the main body support 100, so that the main body support 100 is completely covered by the main body support 100.
  • the main body support 100 can also partially protrude from the graft body 10, and the part of the body support 100 beyond the graft body 10 is bent toward the central axis of the stent-graft 001, so that the body support The part of the stent graft 100 beyond the graft body 10 will not touch the inner wall of the blood vessel after the stent graft 001 is implanted in the blood vessel, so as to prevent the main body support 100 from causing great irritation to the inner wall of the blood vessel.
  • the groove portion 50 is provided on the coating body 10, and the groove portion 50 is located in the middle of the main body coating 10.
  • the groove portion 50 forms a roughly rectangular shape on the coating body 10, that is, when the coating body 10 is unfolded, A window with a rectangle.
  • the membrane stent 001 further includes a groove support frame 54 disposed on the outside of the groove membrane 52 , and protrudes from the surface of the membrane body 10 toward the outside of the groove membrane 52 .
  • the groove support frame 54 is fixed on the edge of the groove portion 50 by suturing, and when the stent graft 001 is implanted at the position of the aortic arch, the groove support frame 54 can support the inner wall of the aortic vessel, thereby playing a more important role. Good fixation.
  • the groove support frame 54 includes a plurality of groove support sections 541, the plurality of groove support sections 541 are connected to the edge of the groove portion 50, and the plurality of groove support sections 541 are connected by hooking each other, A mesh structure with mesh openings 542 is thus formed. That is, the vertices of the adjacent groove support sections 541 are connected by interlocking to prevent the groove support frame 54 from detaching when the stent graft 001 is deformed. At the same time, the mesh 542 formed by the adjacent groove support sections 541 The size can change when subjected to external force, thereby enhancing the elasticity of the groove support frame 54 and improving the wall-adherence of the groove support frame 54 .
  • the groove support frame 54 can also be integrally formed with the main body bracket 002 , and the groove support frame 54 is wave-shaped, which can reduce the cost while satisfying the supporting property of the groove support frame 54 .
  • the body support 100 includes a main stent segment 200 and a support frame segment 300 disposed at a proximal end of the main stent segment 200 .
  • the support frame section 300 includes a connecting corrugated coil 30 and a supporting corrugated coil 40.
  • the connecting corrugated coil 30 is partially connected to the graft body 10.
  • the connecting corrugated coil 30 is used to connect the release mechanism of the graft stent 001.
  • the supporting corrugated coil 40 is arranged on the graft body 10. At the port of the body 10 , the supporting wave coil 40 is used to support the port of the film-covered body 10 .
  • the main body support member 100 is made of a material with good biocompatibility and good elasticity, such as nickel-titanium alloy, stainless steel, etc.
  • the film-covered body 10 is made of a film material with good biocompatibility, such as PET, PTFE, etc.
  • the coating body 10 can be a single-layer structure or a multi-layer structure.
  • the main support section 200 includes several main support wave coils 20, the main support wave coil 20 is a Z-shaped wave coil structure, and the Z-shaped wave coil structure is formed by connecting a plurality of sub-wave coils end-to-end with peaks and troughs. closed-loop structure.
  • the main stent wave coil 20 includes a main stent wave crest 21 , a main stent wave trough 23 , and a main stent connecting rod 22 connecting the main stent wave crest 21 and the main stent wave trough 23 .
  • a plurality of main support wave coils 20 are arranged at intervals, and the main support wave coils 20 are connected and fixed to the main support body 10 .
  • several main bracket wave coils 20 are only connected through the film-coated body 10, and the main bracket wave coils 20 and the film-covered body 10 are fixed by suturing or bonding, and the fixing method is based on actual needs. Make a selection.
  • the main stent crest 21 of one main stent wave coil 20 is set corresponding to the main stent trough 23 of the adjacent main stent wave coil 20, and correspondingly, the main stent trough 23 of one main stent wave coil 20 and the The crests 21 of the adjacent main support corrugations are correspondingly arranged. Therefore, it is ensured that the stent graft 001 has better compliance at the corresponding position where the aortic arch is implanted.
  • the main stent section 200 is a variable-diameter structure, and the diameter of the distal end of the main stent section 200 is smaller than the diameter of the proximal end of the main stent section 200, that is, the diameter of the main stent wave coil 20 located at the distal end of the main stent section 200 is smaller than that located at the main stent section 200.
  • the diameter of the main stent bellows 20 at the proximal end of the segment 200 Therefore, it can better adapt to the shape of the aortic vessel, so that the stent graft 001 can fit the inner wall of the aortic vessel better.
  • the main stent segment 200 can also be a cylindrical hollow tube with equal diameter everywhere.
  • the graft body 10 is attached to the main body support 100 and can change shape along with the body support 100 .
  • the body support 100 is used to stretch the graft body 10 when the stent graft 001 is released.
  • Each main stent corrugation ring 20 is a corrugated metal ring, so that after the stent graft 001 is released, the graft body 10 has a hollow cylindrical structure.
  • the diameters of the wave coils 20 of each main support are the same, or different diameters may be used according to actual needs.
  • both ends of the covering body 10 are openings, and the middle is a closed lumen structure, and the covering body 10 may be a layer of film or a multi-layer film.
  • the coating body adopts a multi-layer film structure, two adjacent layers of films can be fixed together by glue bonding, direct firing or heat treatment.
  • the materials of the two adjacent films may be the same or different.
  • the main support wave coil 20, the connecting wave coil 30 and the supporting wave coil 40 are all made of memory alloy. Formed by cutting and shaping. Nitinol has good fatigue life and strong corrosion resistance. At the same time, by using the memory alloy material to make the main body support 100, the main body support 100 returns to the preset shape at a preset temperature, such as 36°C, and the preset shape can be set according to actual needs, and this application does not make limited.
  • the connecting wave coil 30 can be arranged on the inner side of the membrane body 10, and the supporting wave coil 40 can be arranged on the inner side or the outer side of the membrane body 10, which is selected according to actual needs.
  • the supporting wave coil 40 can be fixed on the covering body 10 by sewing or bonding.
  • the supporting wave coil 40 can be fixed on the coating body 10 by sewing or bonding, or can be fixedly connected with the connecting wave coil 30 by sewing or welding. .
  • the connecting corrugated coil 30 is disposed inside the stent graft 001
  • the supporting corrugated coil 40 is disposed between the graft body 10 and the connecting corrugated coil 30, and the supporting corrugated coil 40 is fixed on the graft body 10 by suturing.
  • the wire diameter of the supporting wave coil 40 is smaller than the wire diameter of the connecting wave coil 30 .
  • the wire diameter of the supporting corrugated coil 40 is set to be smaller than the wire diameter of the connecting corrugated coil 30, thereby reducing the radial support force of the supporting corrugated coil 40, so that the contact surface between the supporting corrugated coil 40 and the inner wall of the blood vessel is softer.
  • the inner wall of the blood vessel is less irritated, which reduces the occurrence of new stent-derived breaches at the proximal end of the covered stent graft 001 in the long term.
  • braiding the braided supporting wave ring 40 with a lower hardness can be selected, so that the radial support force of the supporting wave ring 40 is smaller than that of the connecting wave ring 30 radial support force.
  • the hardness of the supporting wave coil 40 and the connecting wave coil 30 can also be adjusted by changing the processing technology, such as changing the temperature or time of heat treatment.
  • the radial support force of the wave ring can be obtained according to the radial output force of the radial load of the wave ring, and the radial output force (FR) of the radial load is equal to the radial pressure (P) on the wave ring multiplied by the wave ring
  • the cross-sectional area (A), that is, P FR/A.
  • the cross-sectional area of the wave ring is the instantaneous cross-sectional area of the wave ring subjected to radial pressure.
  • the release mechanism 60 of the delivery device includes a sheath tube 61 for accommodating and delivering the stent-graft 001 and a sheath core 62 arranged in the sheath tube 61 .
  • the stent graft 001 is loaded between the sheath tube 61 and the sheath core 62, and the stent graft 001 is in a compressed state.
  • the compressed state of the stent graft 001 is shown in FIG. 12 and FIG. 13 .
  • the supporting wave coil 40 Since the present application arranges the supporting wave coil 40 on the proximal edge of the membrane body 10, the supporting wave coil 40 enhances the supporting strength of the membrane body 10, thereby effectively preventing blood leakage.
  • increasing the support wave coil 40 will increase the radial size of the stent graft 001 in the compressed state.
  • the radial diameter of the sheath tube 61 In order to smoothly install the stent graft 001 into the sheath tube 61, the radial diameter of the sheath tube 61 needs to be adjusted to accommodate a larger diameter. Radial Diameter Stent Graft 001.
  • the wire diameter of the supporting corrugated coil 40 is set to be smaller than the wire diameter of the connecting corrugated coil 30, which can not only reduce the radial support force of the supporting corrugated coil 40, but also make the contact surface between the supporting corrugated coil 40 and the inner wall of the blood vessel It is softer and can also reduce the radial dimension of the stent-graft 001 when it is in a compressed state, so that the stent-graft 001 can be easily loaded into the sheath tube 61 with a smaller radial dimension, thereby facilitating the delivery of the stent-graft 001 by the sheath tube 61 to the lesion site.
  • the connecting wave coil 30 and the supporting wave coil 40 are fixed on the graft body 10 by sutures.
  • the sutures used to fix the connecting wave coil 30 and the supporting wave coil 40 are released, and the connecting wave coil 30 and the supporting wave coil 40 are removed from the main body 10 of the coating.
  • the ring 40 is tested, and the radial support force of the connecting wave ring 30 and the supporting wave ring 40 is tested to ensure that the radial supporting force of the supporting wave ring 40 is smaller than the radial supporting force of the connecting wave ring 30 .
  • the number of wave bands of the supporting wave ring 40 is greater than the number of wave bands of the connecting wave ring 30 , wherein the supporting wave ring 40 includes several supporting wave segments 41 connected in sequence, and the supporting wave ring 40
  • the number of bands is the number of supporting wave segments 41
  • the number of bands connecting the wave ring 30 is the total number of the fixed wave segment 32 and the active wave segment 31
  • the number of wave bands supporting the wave ring 40 is set to be greater than the number of connecting wave rings 30 the number of bands.
  • the supporting corrugated coil 40 is arranged between the graft body 10 and the connecting corrugated coil 30, and the radial support force of the connecting corrugated coil 30 is greater than that of the supporting corrugated coil 40, after the stent-graft 001 is completely released, the connecting corrugated coil 30 will The inner side supports the corrugated coil 40 .
  • the number of bands of the supporting corrugated coil 40 is set to be greater than the number of bands of the connecting corrugated coil 30, so as to disperse the radial support force provided by the connecting corrugated coil 30, so that the pressure on the inner wall of the blood vessel is more uniform.
  • the wire diameter of the supporting wave coil 40 is 0.1 mm to 0.5 mm
  • the wire diameter of the connecting wave coil 30 is 0.3 mm to 1 mm
  • the number of bands of the supporting wave coil 40 is 2 times to 5 times that of the connecting wave coil 30 times.
  • the wire diameter of the supporting wave coil 40 is 0.2 mm
  • the wire diameter of the connecting wave coil 30 is 0.5 mm
  • the number of bands of the supporting wave coil 40 is 3 times the number of bands of the connecting wave coil 30.
  • Both 40 and the connecting wave ring 30 are made of nickel-titanium wire. As shown in FIG. 6 and FIG.
  • the connecting wave coil 30 includes a plurality of connecting band parts 301 connected in sequence, and the connecting band parts 301 are sequentially connected to form a ring-shaped support structure.
  • a number of fixed waveform segments 32 and at least one movable waveform segment 31 are connected to the band part 301, wherein the fixed waveform segment 32 is fixedly connected to the coating body 10, and the movable waveform segment 31 is movably connected to the coating body 10.
  • the wave segment 31 is connected with the release mechanism of the stent graft 001 .
  • the connecting band portion 301 includes three movable waveform segments 31 that are movably connected to the coating body 10, and the three movable waveform segments 31 are evenly arranged along the circumferential direction of the coating body 10, and can also be adjacent to each other. Set or set at intervals, the three movable waveform segments 31 are used to connect with the release mechanism of the delivery device, and release after the stent graft 001 is positioned.
  • the connecting band part 301 may also include four or six active waveform segments 31 for adapting to release mechanisms of delivery devices of different specifications.
  • the sheath core 62 is provided with hooks 63 , the sheath core 62 passes through the inner side of the stent graft 001 and is located in the middle of the stent graft 001 , and the hooks 63 are used to connect with the wave coil 30
  • the hook claw 63 is hooked and fixed with the movable waveform segment 31 of the connecting wave, thereby limiting the position of the stent graft 001 in the conveyor, wherein the front end of the sheath tube 61 is also set
  • the stent-graft 001 is completely released to in blood vessels.
  • the hook claw 63 is hooked and connected with the movable waveform segment 31 , and when the hook claw 63 is released from the connection with the movable waveform segment 31 , the stent graft 001 is completely released in the blood vessel. Before the hook claw 63 is released from the connection with the movable waveform segment 31 , the proximal end of the stent graft 001 is already in a semi-released state due to the structural setting of the connection wave coil 30 . Wherein, the half-released state refers to a state in which the proximal end of the stent-graft 001 is partially expanded.
  • the connecting corrugated coil 30 includes three movable waveform segments 31 uniformly distributed in the circumferential direction. Since the sheath core 62 is located in the middle of the inner side of the stent graft 001, and the claws 63 are arranged on the sheath core 62, when the movable waveform segment 31 is hooked and fixed on the claws 63, the claws 63 divide the three movable waveforms simultaneously. Segment 31 is bound in the middle of the inside of stent-graft 001 .
  • the fixed waveform segment 32 includes a fixed peak 321 , a fixed trough 323 and a fixed probe 322 connecting adjacent fixed peaks 321 and fixed troughs 323 .
  • the active waveform segment 31 includes an active wave crest 311, an active wave trough 313, and an active wave rod 312 connecting adjacent active wave peaks 311 and active wave troughs 313.
  • the active wave trough 313 is fixedly connected with the coating body 10, and the active wave peak 311 and the active wave bar 312 are connected to the The coated body 10 is flexibly connected.
  • the fixed waveform segment 32 and the active waveform segment 31 are arranged at intervals.
  • the movable waveform segment 31 Before the claw 63 is released from the connection with the movable waveform segment 31, the movable waveform segment 31 is bound by the claw 63, and the active peak 311 is connected to the claw 63, and the movable valley 313 is connected to the film body 10, and the active
  • the graft body 10 connected by the troughs 313 is displaced toward the inner side of the stent graft 001 under the pulling effect of the movable wave segment 31 .
  • the fixed wave segment 32 Under the action of its own elastic force, the fixed wave segment 32 generates an outward radial support force on the covering body 10 , thereby stretching the covering body 10 .
  • the fixed waveform segment 32 stretches the graft body 10 outward, while the movable waveform segment 31 pulls the graft body 10 inward, so that the stent graft
  • the front end of 001 forms a half-release state.
  • the top of the fixed peak 321 is flush with the proximal edge of the coating body 10
  • the top of the movable peak 311 is flush with the proximal edge of the coating body 10.
  • the top edges of the fixed peak 321 and the movable peak 311 are flush with the proximal end of the graft body 10 , replacing the bare stent configuration of the traditional aortic stent graft 001 . Therefore, after the stent-graft 001 is released, there is no bare stent portion beyond the proximal end of the stent-graft body 10 , thus avoiding secondary damage to the vessel wall caused by the bare stent portion or barbs of the traditional stent-graft 001 . While protecting the patient's arteries, it can also avoid the problem of blood leakage caused by the beak-like structure of the stent graft 001, and further improve the sealing performance of the stent graft 001.
  • the stent-graft 001 when the stent-graft 001 is implanted at the position of the aortic arch, the stent-graft 001 is arranged in a curved shape as a whole, and the side of the stent-graft 001 facing the branch vessels of the aortic arch is usually defined as the greater curvature side of the stent-graft 001 , the side of the stent-graft 001 away from the branch vessels of the aortic arch is defined as the lesser curvature side of the stent-graft 001 .
  • the groove portion 50 is disposed on the greater curvature side of the stent graft 001 .
  • the main support peak 21 on the small curvature side is coaxial with the fixed peak 321 or the movable peak on the small curvature side and arranged along the same axial direction.
  • the main bracket trough 23 on the small curvature side is coaxial with the fixed trough 323 or the movable trough 313 on the small curvature side and arranged along the same axial direction.
  • the main support wave peak 21 is located on the other side of the groove portion 50.
  • the fixed peaks 321 or the movable peaks 311 on the other side of the groove portion 50 have the same direction and are on the same axis.
  • the main support wave trough 23 is located on the other side of the groove portion 50.
  • the fixed trough 323 or the movable trough 313 on the other side of the groove portion 50 has the same direction and is on the same axis.
  • the peak 21 of the main bracket on the major bending side is in the same direction as the fixed trough 323 or the movable trough 313 on the major bending side, and they are on the same axis.
  • the main bracket wave trough 23 on the big bend side is in the same direction as the fixed peak 321 or the movable peak 311 on the big bend side, and they are on the same axis.
  • the present application ensures that the greater curvature side of the stent graft 001 has a higher hardness at the corresponding position where the aortic arch is implanted, thereby effectively preventing the stent from shortening.
  • the connecting corrugated portion 301 located on the greater bend side of the stent graft 001 is a fixed wave segment 32 .
  • one of the fixed crests 321 of the connecting wave coil 30 is set on the center line of the groove portion 50, and one of the main support wave peaks 21 of the main support wave coil 20 adjacent to the connecting wave coil 30 is set on the center line of the groove portion 30
  • the midline of the groove part 30 in this embodiment is defined as follows: the connection line between the two vertices of the edge connecting the groove part 30 and the graft body 10, wherein the vertices are the most distant from the central axis of the stent graft 001 far away.
  • the axial height of the wave section of the main support wave coil 20 located on the large bending side is greater than the axial length of the wave section on the small bending side, so that the gap between adjacent main support wave coils 20 on the large bending side The distance is shorter than the distance between adjacent main support wave coils 20 on the small bending side. Therefore, the large curved side of the film-covered body 10 is not easy to shorten, and the small curved side has better flexibility.
  • the wire diameter D20 of the wave coil 20 of the main support is 0.3 to 0.45 mm
  • the wave height H20 is 6 to 15 mm
  • the wave number T20 is 6 to 10.
  • the wire diameter D20 of the wave coil 20 of the main support is 0.3 mm
  • the wave height H20 is 8 mm
  • the wave number T20 is 8.
  • the wire diameter D30 connecting the wave coil 30 is 0.3 to 0.45 mm
  • the wave height H30 is 10 to 15 mm
  • the wave number T30 is 4 to 8.
  • the wire diameter D30 connecting the wave coil 30 is 0.4 mm
  • the wave height H30 is 12 mm
  • the wave number T30 is 6.
  • the interval between two adjacent main support wave coils 20 is 1 mm to 2 mm, and the interval between the main support wave coil 20 closest to the connecting wave coil 30 and the connecting wave coil 30 is 1 mm to 2 mm.
  • the fixed trough 323 and the movable trough 313 connecting the corrugated coil 30 to the film body 10 are additionally provided with a suture point 33, and the suture point 33 covers the rounded corners of the fixed trough 323 and the movable trough 313, wherein the axial direction of the suture point 33
  • the length is set to be greater than 0 and less than or equal to 5mm, so as to ensure that the fixed band 32 of the connecting wave coil 30 assembled in the conveyor will not be displaced relative to the main body 10 of the coating, thereby preventing the connecting wave coil 30 from being released from the conveyor
  • the main body 10 of the covering film protrudes from the back.
  • the suture point is used to sew the fixed trough 323 and the movable trough 313 on the main body
  • the stitching point 33 may also be replaced by a bonding point.
  • the supporting wave coil 40 includes several supporting wave segments 41 connected in sequence, the supporting wave segments 41 are arranged in an inverted 8 shape or a diamond shape, and a plurality of supporting wave segments 41 form a nickel-titanium alloy ring.
  • the support strength of the support wave coil 40 is enhanced, so that the wall-attachment effect of the stent graft 001 is better.
  • the assembly allowable deviation of the supporting wave coil 40 is also ⁇ 1 mm, and the assembly allowable deviation of the fixed wave crest 321 is ⁇ 1 mm.
  • the connecting band portion 301 and the supporting wave segment 41 are arranged in a circumferential direction in a misalignment.
  • the connecting wave coil 30 is set with half a phase difference with respect to the supporting wave coil 40 , so that the whole of the connecting wave coil 30 and the supporting wave coil 40 has a better supporting performance for the coating body 10 .
  • the size parameter setting of the above-mentioned stent graft is only an example of this implementation, and is applicable to most application scenarios, but does not constitute a limitation to this application. If there is a special size requirement, the technical solution of this application can also be adopted other size parameters.
  • the supporting wave coil 40 can be fixedly connected with the membrane main body 10 , and the supporting wave coil 40 is fixedly connected with the membrane main body 10 by suturing or bonding.
  • the supporting wave coil 40 can also be fixedly connected to the connecting wave coil 30 , and the supporting wave coil 40 is fixedly connected to the connecting wave coil 30 by means of sewing, bonding or welding. In this embodiment, the supporting wave coil 40 is fixedly connected to the covering body 10 by suturing.
  • the proximal end of the supporting wave coil 40 is flush with the proximal end edge of the membrane body 10 ; or the distal end of the supporting wave coil 40 is flush with the distal end of the connecting wave coil 30
  • the edges are flush, and the proximal end of the supporting corrugated coil 40 is farther away from the proximal end of the covering body 10 than the proximal end of the connecting corrugated coil 30, which facilitates the connection between the connecting corrugated coil 30 and the conveyor; or the supporting corrugated coil 40 is set Between the distal end of the corrugated coil 30 and the proximal end of the graft body 10 is connected to both prevent internal leakage and facilitate connection.
  • the supporting wave coil 40 is fixedly connected to the covering body 10 by suturing.
  • the near-end crest of the support wave ring 40 is flush with the proximal edge of the film-covered body 10, so as to enhance the support strength of the proximal end of the film-covered body 10, thereby better preventing endoleak.
  • proximal edge of the graft body 10 is within the diameter of the support coil 40.
  • the lateral displacement occurs under the action of the support force, so that the proximal edge of the graft body 10 can be closer to the inner wall of the blood vessel to a greater extent before the stent graft 001 is fully released.
  • the hook claw 63 Before the hook claw 63 is released from the connection with the undulating waveform segment, the hook claw 63 binds the active peak 311 of the movable waveform segment 31 in the middle of the stent graft 001, so the hook claw 63 is released from the bondage of the movable waveform segment 31 At the moment, the active wave segment 31 will rebound under the action of its own elastic force, especially the active wave peak 311 at the proximal end has the largest moving distance. During the rebound process of the movable waveform segment 31 , the movable waveform segment 31 will first contact the covering body 10 , and then drive the covering body 10 to contact the inner wall of the blood vessel.
  • the movable waveform segment 31 will quickly drive the coating body 10 against the inner wall of the blood vessel at the moment of contact and restraint, causing an impact on the inner wall of the blood vessel, causing discomfort to the patient. even lead to vasospasm.
  • the support wave coil 40 is provided at the proximal end of the membrane body 10, and the proximal peak of the support wave coil 40 is flush with the proximal edge of the membrane body 10, the proximal edge of the membrane body 10 is Before the stent graft 001 is fully released, it can approach the inner wall of the blood vessel to a large extent. Therefore, at the moment when the active waveform segment 31 contacts and restrains, the impact of the active waveform segment 31 , especially the active wave peak 311 on the inner wall of the blood vessel is greatly resolved.
  • the supporting wave coil 40 can also be configured as a sine wave, a Z-shaped wave, an M-shaped wave or a V-shaped wave. Therefore, the above-mentioned structure supporting the wave coil 40 of the present application is only an example, and any other structure capable of supporting the membrane body 10 can be applied to the present application.
  • the main body support 100 and/or the supporting film 10 is provided with a developing part. When the developing part is arranged on the main body support 100, for example, when the developing part is arranged on the main support section 200, the developing part can be welded, sewn or bonded. on the main bracket segment 200 . When the developing member is disposed on the supporting film 10 , the developing member may be sewn or glued on the supporting film 10 .
  • the developing parts can be set in O-shaped, 8-shaped or N-shaped, that is, they are distinguished by different shapes.
  • the developing parts can be set as developing points with different blackness, that is, they can be distinguished by different color depths.
  • the developing part 11 is arranged on the supporting membrane 10, and the developing part 11 includes a first developing point 111, a second developing point 112 and a third developing point 113, which are used to display the proximal end of the stent graft 001. position and the position of the groove portion 50.
  • the first developing point 111 is arranged on the center line of the groove part 50, and the first developing point 111 is arranged on the edge of the proximal end of the support frame segment 300, and the first developing point 111 can be arranged on the support frame segment 300 or on the On the film body 10.
  • the second developing point 112 is set on the centerline of the groove portion 50 , and the second developing point 112 is set on the edge of the supporting frame segment 300 opposite to the groove portion 50 , and the second developing point 112 is set on the film body 10 .
  • the third development point 113 is arranged on the other side of the center line of the groove portion 50, and the third development point 113 is arranged on the edge of the proximal end of the support frame segment 300.
  • the third development point 113 can be arranged on the support frame segment 300 or set on the film body 10.
  • the shape of the first developing point 111 is different from the shape of the second developing point 112, the shape of the first line developing point is different from the shape of the third developing point 113, the shape of the second developing point 112 and the shape of the third developing point 113 can be The same may also be different.
  • the first developing point 111 is in the shape of 8
  • the second developing point 112 and the third developing point 113 are in the shape of O.
  • first developing point 111 and the third developing point 113 are used to display the position of the proximal end of the stent graft 001 and the angle at which the groove portion 50 is placed.
  • the second development point 112 is used to show the position of the edge of the groove portion 50 .
  • the first developing point 111 and the third developing point 113 are both arranged on the edge of the proximal end of the stent segment 300 , when the stent-graft 001 is implanted, the proximal position of the stent-graft 001 can be displayed. Moreover, the first imaging point 111 is placed toward the direction of the branch arteries of the aortic arch, and the third development point 113 is placed away from the direction of the branch arteries of the aortic arch. Since the first developing point 111 is arranged in the same direction as the groove portion 50 , the angle at which the groove portion 50 is arranged can also be displayed.
  • the first developing point 111 is located at the proximal edge of the greater curvature side of the stent graft 001, indicating the position of the proximal greater curvature side of the stent graft 001
  • the third developing point 113 is located at the proximal edge of the lesser curvature side of the stent graft 001 , indicating the position of the lesser curvature side of the stent graft 001.
  • an eighth developing point 118 is also set on the coating body 10 , the eighth developing point 118 is set on the midpoint of the groove portion 50 , and the eighth developing point 118 It is arranged on the edge of the end opposite to the groove portion 50 away from the support frame segment 300 .
  • the two sides of the supporting ring set in the suturing ring 53 can also be provided with developing strips 119 for displaying the outline of the groove coating 52 , so as to facilitate the positioning when implanting the stent graft 001 .
  • the eighth development point 118 and the development strip 119 on the stent graft 001 by setting the eighth development point 118 and the development strip 119 on the stent graft 001, the overall edge position of the groove part 50 can be indicated during the operation, and the relative position of the guide wire relative to the groove part 50 can be indicated, so that When assisting the doctor to confirm the guide wire approach, the guide wire is located inside the groove to ensure the success rate of the operation.
  • the distance between the through hole 521 and the proximal end of the support frame segment 300 is less than or equal to the distance between the second developing point 112 and the proximal end of the support frame segment 300 , so that the positional relationship between the edge of the groove portion 50 and the through hole 521 is shown by the second developing point 112 .
  • the branch bracket 003 Since the branch bracket 003 is sewn to the groove portion 50 through the through hole 521 , there may be a seam edge between the through hole 521 and the groove portion 50 during sewing, or a retracted through hole 521 may be used in the design. Therefore, in the above case, the distance between the through hole 521 and the proximal end of the support frame segment 300 is set to be smaller than the distance between the second developing point 112 and the proximal end of the support frame segment 300 .
  • the connecting coil avoids secondary damage to the inner wall of the blood vessel in the anchoring area by the exposed connecting coil, and the active waveform of the connecting coil 30 is
  • the semi-connection between the section 31 and the graft body 10 satisfies the cooperative use of the release device behind the stent graft 001 .
  • the supporting corrugated coil 40 can strengthen the support of the membrane, ensuring that the proximal end of the stent-graft 001 can completely adhere to the wall after release, and avoid the bird's beak shape at the proximal end of the stent and cause blood leakage.
  • Embodiment 2 of the present application provides a stent graft, as shown in FIG. 17 , the similarities between Embodiment 2 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 2 and Embodiment 1
  • the difference is that adjacent main bracket wave coils 20 are connected by connecting rods 24, and multiple connecting rods 24 are arranged on the same side as the groove portion 50, and the multiple connecting rods 24 are on the same side as the center line of the groove portion 50. on a straight line, thereby increasing the supporting strength of the stent graft 001.
  • the connecting rod 24 is connected to the wave coil 20 of the main support through a steel sleeve, or the connecting rod 24 is welded on the wave coil 20 of the main support.
  • a plurality of connecting rods 24 can also be arranged in a misplaced position, and two adjacent main support wave coils 20 are connected by a connecting rod 24, and the connecting rod 24 is arranged at the groove part 50 Just the same side.
  • the connecting rods 24 are provided between adjacent main stent coils 20 , so as to ensure the bending direction of the stent graft 001 after implantation, and improve the supportability of the stent graft 001 at the same time.
  • Embodiment 3 of the present application provides a stent graft, as shown in FIG. 18 and FIG. 19 .
  • the similarities between Embodiment 3 of the present application and Embodiment 1 will not be repeated here.
  • One difference is that the movable probe 312 is set at a preset angle with the film covering body 10 . Wherein, the movable probe 312 is bent toward the inner side of the film-covered body 10 , and the preset angle is greater than 0° and less than or equal to 45°, for example, 30°. Therefore, the movable crest 311 follows the movable wave rod 312 and bends towards the inner side of the coating body 10 .
  • the distance between the active peak 311 and the center of the connecting wave 30 is smaller than the distance between the fixed peak 321 and the center of the connecting wave 30 .
  • the movable wave rod 312 that is movably connected to the graft body 10 is bent from the root toward the inner side of the stent graft 001, thereby avoiding the impact of the elastic force of the movable waveform segment 31 on the blood vessel during the post-release process.
  • the movable wave rod 312 is bent inward, which can also reduce the long-term stimulation to the inner wall of the blood vessel caused by the active wave crest 311 standing against the inner wall of the blood vessel for a long time.
  • Embodiment 4 of the present application provides a stent graft, as shown in FIG. 20 and FIG. 21 .
  • the similarities between Embodiment 4 and Embodiment 2 of the present application will not be repeated here.
  • the difference between the three is that the movable wave rod 312 includes a bent portion 314 connected to the movable peak 311 , and the bent portion 314 is set at a preset angle with the coating body 10 .
  • the bending portion 314 is bent toward the inner side of the film-coated body 10, the preset angle is greater than 0° and less than or equal to 45°, such as 30°, and the length ratio of the bending portion 314 to the movable wave rod 312 is greater than or equal to 30% and less than equal to 60%. Therefore, the movable peak 311 follows the bending portion 314 and bends towards the inner side of the membrane body 10 .
  • the distance between the active peak 311 and the center of the connecting wave 30 is smaller than the distance between the fixed peak 321 and the center of the connecting wave 30 .
  • 30% to 60% of the length of the proximal end of the movable wave rod 312 is set as the bending portion 314 . Since the bent portion 314 is disposed between the movable peak 311 and the movable trough 313 , and the bent portion 314 is close to the movable crest 311 , the movable wave rod 312 can provide supporting force near the root of the movable trough 313 .
  • the movable wave rod 312 is bent inward, which can also reduce the long-term stimulation to the inner wall of the blood vessel caused by the active wave crest 311 standing against the inner wall of the blood vessel for a long time.
  • Embodiment 5 of the present application provides a stent graft, as shown in Figure 22, the similarities between Embodiment 5 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 5 and Embodiment 1
  • the advantage is that the shape of the supporting corrugated coil 40 is the same as that of the connecting corrugated coil 30, both of which are wave-shaped, and the supporting corrugated coil 40 and the connecting corrugated coil 30 are arranged in a misaligned manner, and the supporting corrugated coil 40 and the coating body 10 are completely fixed .
  • both the supporting corrugated coil 40 and the connecting corrugated coil 30 are sinusoidal, and the position of the supporting corrugated coil 40 is the position corresponding to the half cycle of the circumferential rotation of the connecting corrugated coil 30, and the supporting corrugated coil 40 is stitched The way is fixed with the film body 10.
  • the supporting wave coil 40 is arranged on the outer side of the coating body 10 (at this time, in the radial direction, the coating body 10 is located between the connecting wave coil 30 and the supporting wave coil 40), or in the radial direction, the supporting wave coil 40 It is arranged on the inner side of the covering body 10, and the supporting wave coil 40 is arranged between the covering film body 10 and the connecting wave coil 30, so as to ensure that the movable wave segment 31 of the connecting wave ring 30 can be connected to the release mechanism of the delivery device. At the same time, the support of the proximal end of the covering body 10 is ensured, the risk of blood endoleak is reduced, and the stimulation of the connecting corrugated coil 30 to blood vessels is reduced.
  • Embodiment 6 of the present application provides a stent graft, as shown in FIG. 23 , the similarities between Embodiment 6 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 6 and Embodiment 1
  • the advantage is that the supporting wave coil 40 includes several independent supporting units 42 , and each independent supporting unit 42 is combined and distributed between the crests and troughs of the connecting wave coil 30 .
  • the supporting wave coil 40 of this embodiment includes a number of supporting units 42 uniformly distributed in the circumferential direction between the crests and troughs of the connecting wave coil 30.
  • the proximal end of the membrane body 10 is flush.
  • the support unit 42 is rhomboid, and the major axis of the rhombus is parallel to the longitudinal central axis of the stent-graft.
  • the support unit 42 may be elliptical, and its long axis is parallel to the longitudinal central axis of the stent-graft.
  • the radial dimension of the stent-graft after compression is reduced and the strength of the proximal end of the stent-graft body 10 is improved.
  • a balance makes the proximal end of the covering body 10 not only have better support, which reduces the risk of blood endoleak, but also has a smaller size after radial compression.
  • Embodiment 7 of the present application provides a stent graft, as shown in Figure 24, the similarities between Embodiment 7 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 7 and Embodiment 1
  • the difference is that the connecting wave coil 30 includes several connecting band parts 301 connected in sequence, and the connecting band parts 301 include fixed waveform segments 32 and movable waveform segments 31 arranged at intervals in sequence, and the connecting band parts 301 are all arranged on the coating body 10 of the inner surface.
  • the fixed waveform segment 32 is arranged in a ring shape, and the fixed waveform segment 32 is completely fixedly connected to the film body 10.
  • the movable waveform segment 31 is arranged between the adjacent fixed waveform segments 32, and the movable waveform segment 31 is arranged in a strip shape.
  • the movable waveform segment 31 is movably connected to the covering body 10 .
  • the movable waveform segment 31 protrudes toward the proximal end of the film-graft body 10 to form an active peak 311 for connecting to the release mechanism of the delivery device, and the proximal end of the active wave peak 311 is flush with the proximal end of the film-graft body 10 Or the inside of the active peak 311 (that is, the active peak 311 is closer to the distal end of the graft body 10 than the proximal end of the graft body 10).
  • Both sides of the movable peak 311 are respectively provided with movable wave rods 312, and the movable wave rods 312 on both sides are respectively fixedly connected with the fixed wave segments 32 on the corresponding sides.
  • the fixed wave segment 32 is fixedly connected to the covering body 10 by sewing, and the movable wave segment 31 is connected to the fixed wave segment 32 by welding.
  • the active peak 311 located inside the graft body 10 is connected to the release structure of the delivery device, so as to reduce the stimulation of the active peak 311 to the inner wall of the blood vessel and achieve the purpose of releasing the stent.
  • Embodiment 8 of the present application provides a stent graft, as shown in Figure 25, the similarities between Embodiment 8 of the present application and Embodiment 7 will not be repeated, and the differences between Embodiment 8 and Embodiment 7 The difference is that the movable waveform segment 31 is arranged in a ring shape, and part of the movable waveform segment 31 is fixedly connected to the coating body 10 , and part is separated from the coating body 10 .
  • the fixed waveform segment 32 is set between the adjacent movable waveform segments 31, the fixed waveform segment 32 is arranged in a strip shape, and the fixed waveform segment 32 is completely fixedly connected to the film body 10, and the fixed waveform segment 32 can be a straight line
  • the segment shape which can also be a curved segment shape.
  • the movable waveform segment 31 includes a side near the proximal end of the graft body 10 and is movably connected to a movable proximal portion 316 of the graft body 10, and a side away from the proximal end of the graft body 10 and is fixedly connected to the graft body 10.
  • the movable distal portion 315 of the membrane body 10 is flush with the proximal end of the graft body 10 , or a predetermined indentation distance is set between the movable proximal portion 316 and the graft body 10 .
  • the predetermined indentation distance is 0.5 mm to 2 mm.
  • the movable proximal portion 316 located at the proximal end of the movable waveform segment 31 is connected to the release structure of the delivery device, so as to realize the storage of the connecting coil 30 inside the graft body 10 to reduce the stimulation of the bare stent to the inner wall of the blood vessel.
  • the purpose of releasing the bracket is accomplished.
  • Embodiment 9 of the present application provides a stent graft, as shown in Figure 26 and Figure 27 , the similarities between Embodiment 9 of the present application and Embodiment 1 will not be repeated, and Embodiment 9 and Embodiment The first difference is that, as shown in FIG. 1 , the developing member 11 also includes a fourth developing point 114 and a fifth developing point 115 arranged on the film body 10, the fourth developing point 114 and the fifth developing point 115 are respectively Two sides of the film covering body 10 near the proximal end of the groove portion 50 are provided.
  • the fourth developing point 114 and the fifth developing point 115 are respectively set on both sides of the proximal end of the groove coating 52 to indicate the positions of the two proximal sides of the groove coating 52 .
  • the doctor can accurately know the position of the proximal end of the groove coating 52 at the bottom of the groove part 50, which provides convenience for the doctor's observation and operation.
  • the sixth development point 116 and the seventh development point 117 are also provided on the groove coating film 52 of the groove part 50, and the sixth development point 116 and the seventh development point 117 are respectively arranged on the groove surface.
  • the middle portion of the proximal and distal ends of the membrane 52 are respectively arranged on the groove surface.
  • the shape of the first developing point 111 is different from that of the third developing point 113
  • the shape of the sixth developing point 116 is different from that of the second developing point 112
  • the shape of the seventh developing point 117 is different from that of the eighth developing point 118, thus It is more obvious to distinguish each developing point.
  • the present application provides a stent graft. Compared with the connection coil structure of the existing aortic stent graft, it avoids secondary damage to the inner wall of the vessel in the anchoring area by the exposed connection coil.
  • the semi-connection mode between the active waveform segment of the corrugated coil and the graft body satisfies the cooperative use of the release device after the stent graft.

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Abstract

一种覆膜支架（001），包括主体支撑件（100）以及设置在主体支撑件（100）上的覆膜本体（10），其中，主体支撑件（100）包括主支架段（200）以及设置在主支架段（200）近端的支撑架段（300），支撑架段（300）包括与覆膜本体（10）部分连接的连接波圈（30），连接波圈（30）包括若干与覆膜本体（10）固定连接的固定波形分段（32）以及至少一个与覆膜本体（10）活动连接的活动波形分段（31）。覆膜支架（001）能够避免主动脉内膜容易被传统覆膜支架的裸支架或倒刺损伤的问题，保护了患者的锚定区血管内壁，且贴壁效果更好。

Description

一种覆膜支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种覆膜支架。
背景技术
主动脉瘤和主动脉夹层是当前严重危害人类生命安全的疾病，若不积极治疗，主动脉瘤体和夹层会不断增大，最后破裂，造成严重的并发症和死亡，随着高血压、高血脂和高糖尿病患者的不断增加，目前主动脉瘤和主动脉夹层的发病率也在显著增高。
传统的开放性手术治疗主动脉瘤和主动脉夹层创伤大、死亡率高、手术时间长、术后并发症发生率高和手术难度高，而腔内治疗具有创伤小、术后并发症少，手术时间短和手术难度低等特点而逐渐成为当前治疗主动脉瘤和主动脉夹层的主要方式。通过在主动脉植入覆膜支架，将血管病变隔绝在覆膜支架外，约束血流从覆膜支架内部流过，从而达到保护血管的目的。
传统的主动脉覆膜支架一般会在支架的近端(覆膜支架释放后靠近心脏一侧)露出记忆金属合金制成的裸支架，或者在支架的外侧壁上设置倒刺，以便在手术中及术后初期，覆膜支架能够准确的放置在动脉中，并保证覆膜支架不后撤。
但是，采用上述方式的裸支架和倒刺会一直保留在动脉中，久而久之，会对患者动脉造成一定程度的损伤，造成主动脉内膜及中 膜的破裂，出现新的主动脉夹层。并且，当夹层逆行剥离，锚定区部分内膜脆弱，上述方式有可能在释放支架时就损伤内膜，造成内膜破裂，形成新的破口。因此，需要一种新的技术方案解决上述问题。
发明内容
本发明的目的是至少解决主动脉内膜容易被覆膜支架的裸支架或倒刺损伤的问题。
本发明的一方面提出了一种覆膜支架，包括主体支撑件以及设置在所述主体支撑件上的覆膜本体，其中，所述主体支撑件包括主支架段以及设置在所述主支架段近端的支撑架段，所述支撑架段包括与所述覆膜本体部分连接的连接波圈，所述连接波圈包括若干与所述覆膜本体固定连接的固定波形分段以及至少一个与所述覆膜本体活动连接的活动波形分段。
根据本发明中的覆膜支架，能够避免主动脉内膜容易被传统覆膜支架的裸支架或倒刺损伤的问题，保护了患者的锚定区血管内壁，且贴壁效果更好。
在本发明的一些实施例中，所述固定波形分段与所述活动波形分段依次间隔设置。
在本发明的一些实施例中，所述固定波形分段包括固定波峰、固定波谷以及连接相邻所述固定波峰和固定波谷的固定波杆，所述固定波峰的顶部与所述覆膜本体的近端边缘平齐；
所述活动波形分段包括活动波峰、活动波谷以及连接相邻所述活动波峰和活动波谷的活动波杆，所述活动波谷与所述覆膜本体固定连接，所述活动波峰以及所述活动波杆与所述覆膜本体活动连接。
在本发明的一些实施例中，所述活动波杆与所述覆膜本体呈预设角度设置；或所述活动波杆包括与所述活动波峰连接的折弯部，所述折弯部与所述覆膜本体呈预设角度设置。
在本发明的一些实施例中，所述活动波杆朝向所述覆膜本体的内侧弯折，或所述折弯部朝向所述覆膜本体的内侧弯折，所述预设角度大于0°且小于等于45°，所述折弯部的长度与所述活动波杆的长度之比的百分率大于或等于30％且小于或等于60％。
在本发明的一些实施例中，所述支撑架段还包括设置在所述支撑覆膜端口处的支撑波圈，所述支撑波圈的丝径小于所述连接波圈的丝径。
在本发明的一些实施例中，所述支撑波圈的波段数大于所述连接波圈的波段数。
在本发明的一些实施例中，所述支撑波圈与所述覆膜本体固定连接，或所述支撑波圈与所述连接波圈固定连接。
在本发明的一些实施例中，所述支撑波圈的近端与所述覆膜本体的近端边缘平齐，或所述支撑波圈的远端与所述连接波圈的远端边缘平齐，或所述支撑波圈设置在所述连接波圈的远端与覆膜本体的近端之间。
在本发明的一些实施例中，所述主体支撑件上设置有朝向所述 主体支撑件内侧凹陷的凹槽部，所述凹槽部包括与所述主体支撑件连接的凹槽支撑件以及设置在凹槽支撑件上的凹槽覆膜；所述主体支撑件和/或所述支撑覆膜上设置有显影件。
附图说明
图1为本发明的实施例一中覆膜支架的整体结构示意图；
图2为本发明的实施例一中分支支架的结构示意图
图3为本发明的实施例一中覆膜支架近端部分的结构示意图；
图4为本发明的实施例一中覆膜支架近端部分另一实施方案的结构示意图；
图5为本发明的实施例一中主支架波圈的结构示意图；
图6为本发明的实施例一中连接波圈的结构示意图；
图7为本发明的实施例一中连接波圈与覆膜本体的连结构示意图；
图8为本发明的实施例一中支撑波圈的结构示意图；
图9为本发明的实施例一中覆膜支架处于半释放状态时的结构示意图；
图10为本发明的实施例一中覆膜支架处于半释放状态时输送装置与覆膜支架的连接结构示意图；
图11为本发明的实施例一中主支架波圈另一实施方式的结构示意图；
图12为本发明的实施例一中覆膜支架在鞘管内的结构示意图；
图13为本发明的实施例一中覆膜支架在鞘管内的剖面图；
图14为本发明的实施例一中连接波圈与支撑波圈相差半个相位设置的结构示意图；
图15为本发明的实施例一中显影条的结构示意图；
图16为本发明的实施例一中显影条另一视角的结构示意图；
图17为本发明的实施例二中连接杆的结构示意图；
图18为本发明的实施例三中连接波圈的侧视图；
图19为本发明的实施例三中连接波圈的正视图；
图20为本发明的实施例四中连接波圈的侧视图；
图21为本发明的实施例四中连接波圈的正视图；
图22为本发明的实施例五中覆膜支架近端部分的结构示意图；
图23为本发明的实施例六中覆膜支架近端部分的结构示意图；
图24为本发明的实施例七中覆膜支架近端部分的结构示意图；
图25为本发明的实施例八中覆膜支架近端部分的结构示意图；
图26为本发明的实施例九中覆膜支架的显影件的结构示意图；
图27为本发明的实施例九中覆膜支架的显影件另一视角的结构示意图。
附图中各标号表示如下：
001、覆膜支架；002、主体支架；003、分支支架；100、主体支撑件；200、主支架段；300、支撑架段；400、分支支撑件；401、分支波圈；402、分支连接杆；403、显影环；500、分支覆膜；
10、覆膜本体；11、显影件；111、第一显影点；112、第二显 影点；113、第三显影点；114、第四显影点；115、第五显影点；116、第六显影点；117、第七显影点；118、第八显影点；119、显影条；20、主支架波圈；21、主支架波峰；22、主支架连杆；23、主支架波谷；24、连接杆；30、连接波圈；301、连接波段部；31、活动波形分段；311、活动波峰；312、活动波杆；313、活动波谷；314、折弯部；315、活动远端部；316、活动近端部；32、固定波形分段；321、固定波峰；322、固定波杆；323、固定波谷；33、缝合点；40、支撑波圈；41、支撑波形分段；42、支撑单元；50、凹槽部；51、凹槽支撑件；52、凹槽覆膜；521、通孔；53、缝合圈；54、凹槽支撑架；541、凹槽支撑段；542、网孔；60、释放机构；61、鞘管；62、鞘芯；63、钩爪；64、引导部。
具体实施方式
下面将参照附图更详细地描述本发明的示例性实施方式。虽然附图中显示了本发明的示例性实施方式，然而应当理解，可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本发明，并且能够将本发明的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包 含性的，并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在，但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行，除非明确指出执行顺序。还应当理解，可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此，以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如，如果在图中的装置翻转，那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。 因此，示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
为了便于描述，以下描述使用术语“远端”和“近端”，其中“远端”是指的是离心脏远的一端，“近端”是指离心脏近的一端，短语“轴向方向”，本专利里应当被理解成表示介入器械被推进和推出的方向，与“轴向方向”相垂直的方向定义为“径向方向”。
实施例一，如图1至图3所示，本实施例的覆膜支架001整体呈两端具有开口的中空管状结构，包括主体支架002以及分支支架003，分支支架003设置在主体支架002的内部，主体支架002用于植入主动脉血管内，分支支架003用于植入分支血管内。其中，分支支架003呈中空的圆柱形结构，分支支架003沿主体支架002的长度方向设置，主体支架002包括主体支撑件100以及覆膜本体10。其中，分支支架003与主体支撑件100的轴向方向相同。
在其他实施方式中，分支支架003与主体支撑件100呈预设角度设置，该预设角度可以为3°、5°或10°等，具体根据实际需要进行设置。
主体支架002的表面设置有朝向主体支架002内侧凹陷的凹槽部50，凹槽部50的边缘连接于主体支架002的覆膜本体10，凹槽部50包括凹槽支撑件51以及设置在凹槽支撑件51上的凹槽覆膜52。其中，凹槽支撑件51与主体支撑件100相连接，凹槽覆膜52与覆膜本体10相连接。
在本实施例中，凹槽覆膜52的边缘通过缝合的方式与覆膜本体10相连接。具体的，凹槽覆膜52与覆膜本体10之间设置有缝合圈53，且凹槽覆膜52与覆膜本体之间通过缝合圈53连接。缝合圈53内可以设置有用于加强凹槽部50支撑强度的支撑环圈(图中未示出)，支撑环圈为具有弹性的金属环圈。
在其他实施方式中，凹槽覆膜52还可以与覆膜本体10一体成型，凹槽覆膜52通过缝合等方式固定在凹槽支撑件51上。凹槽支撑件51相对于主体支撑件100内凹，凹槽支撑件51用于将凹槽覆膜52进行定型，从而形成整体内凹的凹槽部50。
凹槽覆膜52上设置有通孔521，分支支架003连通于通孔521，从而使得血液从主体支架002内经过通孔521流入分支支架003内，其中，分支支架003通过缝合的方式固定连接于通孔521。主体支架002内包括一个或多个分支支架003，多个分支支架003的直径可以相同也可以不同，根据实际需要进行设置。
在本实施例中，覆膜支架001包括三个分支支架003，其中，两个分支支架003靠近凹槽部50的近端设置，一个分支支架003靠近凹槽部50的远端设置。
分支支架003包括分支支撑件400以及设置在分支支撑件400上的分支覆膜500，分支覆膜500通过缝合的方式连接于通孔521。其中，通孔521的外缘通过缝合线缝合有显影环403，用于显示分支支架003所处的位置。其中，分支支撑件400包括若干间隔设置的分支波圈401，相邻分支波圈401之间设置有分支连接杆402，分支 波圈401呈波浪形或菱形。
覆膜本体10设置在主体支撑件100上，应当理解的是，主体支撑件100可以设置在覆膜本体10的内表面，也可以设置在覆膜本体10的外表面，或者一部分主体支撑件100设置在覆膜本体10的内表面，另一部分主体支撑件100设置在覆膜本体10的外表面。
在本实施例中，覆膜本体10的长度大于或等于主体支撑件100的长度，从而覆膜本体10将主体支撑件100完全覆盖，即主体支撑件100不存在裸支架部分，从而在覆膜支架001植入血管内以后，避免了主体支撑件100对血管内壁造成的伤害，避免主体支撑件100对血管内壁产生较大的刺激。
在其他实施方案中，主体支撑件100也可以部分地超出覆膜本体10，且超出覆膜本体10的主体支撑件100部分，朝向覆膜支架001的中心轴线方向弯折，以使主体支撑件100超出覆膜本体10的部分在覆膜支架001植入血管内后，也不会接触到血管内壁，从而避免主体支撑件100对血管内壁产生较大刺激。
凹槽部50开设在覆膜本体10上，且凹槽部50位于主体覆膜10的中部，凹槽部50在覆膜本体10上形成大致矩形的形状，即当覆膜本体10展开时，具有矩形的窗口。
覆膜支架001还包括凹槽支撑架54，凹槽支撑架54设置在凹槽覆膜52的外侧，且凹槽支撑架54朝向凹槽覆膜52的外侧凸出覆膜本体10的表面。其中，凹槽支撑架54通过缝合的方式固定于凹槽部50的边缘，且当覆膜支架001植入到主动脉弓的位置时，凹槽支 撑架54能够支撑主动脉血管内壁，从而起到更好的固定作用。
具体的，凹槽支撑架54包括多个凹槽支撑段541，多个凹槽支撑段541与凹槽部50的边缘相连，且多个凹槽支撑段541通过互相钩挂的方式相连接，从而形成具有网孔542的网状结构。即相邻凹槽支撑段541的顶点通过互挂的方式进行连接，防止凹槽支撑架54在覆膜支架001发生形变时产生脱离，同时，相邻凹槽支撑段541形成的网孔542的尺寸在受到外力时可发生变化，从而增强了凹槽支撑架54的弹性，提高了凹槽支撑架54的贴壁性。
在其他实施例中，凹槽支撑架54还可以与主体支架002一体成型，且凹槽支撑架54呈波浪形，能够在满足凹槽支撑架54支撑性的同时降低成本。
主体支撑件100包括主支架段200以及设置在主支架段200近端的支撑架段300。支撑架段300包括连接波圈30以及支撑波圈40，连接波圈30与覆膜本体10部分连接，连接波圈30用于连接覆膜支架001的释放机构，支撑波圈40设置在覆膜本体10的端口处，支撑波圈40用于支撑覆膜本体10的端口处。
其中，主体支撑件100采用具有良好生物相容性和良好弹性的材料制成，例如，镍钛合金、不锈钢等，覆膜本体10采用良好生物相容性的薄膜材料制成，例如，PET、PTFE等。覆膜本体10的可以为单层结构，也可以多层结构。
如图3至图5所示，主支架段200包括若干主支架波圈20，主支架波圈20为Z型波圈结构，Z型波圈结构由多个子波圈首尾相连 形成具有波峰和波谷的闭环结构。
具体的，主支架波圈20包括主支架波峰21、主支架波谷23以及连接主支架波峰21和主支架波谷23的主支架连杆22。若干主支架波圈20间隔设置，主支架波圈20与覆膜本体10连接固定。其中，若干主支架波圈20之间仅通过覆膜本体10进行连接，主支架波圈20与覆膜本体10之间采用缝合方式进行固定，或者采用粘接方式进行固定，固定方式根据实际需要进行选择。
在本实施例中，一个主支架波圈20的主支架波峰21与相邻的主支架波圈20的主支架波谷23相对应设置，相应的，一个主支架波圈20的主支架波谷23与相邻的主支架波圈的主支架波峰21相应对设置。从而保证了覆膜支架001在植入主动脉弓对应位置处，具有更好的顺应性。
主支架段200为变径结构，主支架段200的远端的直径小于主支架段200的近端的直径，即位于主支架段200的远端的主支架波圈20的直径小于位于主支架段200的近端的主支架波圈20的直径。从而更好的适应主动脉血管的形状，以使覆膜支架001能够更好的贴合主动脉血管内壁。
在其他实施例中，当覆膜支架001适用于其他主动脉血管部位时，主支架段200还可以为直径处处相等的圆柱形空心管体。
在本实施例中，覆膜本体10依附于主体支撑件100，可随着主体支撑件100改变形状，主体支撑件100用于在覆膜支架001释放时，撑开覆膜本体10。每个主支架波圈20均为波浪状的金属环，从 而在覆膜支架001释放后，覆膜本体10呈空心的圆筒状结构。其中，每个主支架波圈20的直径相同，或者根据实际需要采用不同直径的设置。
其中，覆膜本体10两端为开口，中间为封闭的管腔结构，覆膜本体10可以为一层膜或者多层膜。当覆膜本体采用多层膜结构时，相邻的两层膜之间可以采用胶水粘接、直接烧制或者热处理等方式固定在一起。相邻的两层膜的材料可以相同也可以不相同。
主支架波圈20、连接波圈30和支撑波圈40均采用记忆合金制成，例如，主支架波圈20、连接波圈30和支撑波圈40均采用镍钛合金丝编织或镍钛管切割定型的方式形成。镍钛合金的疲劳寿命好，耐腐蚀性强。同时，通过采用记忆合金材料制成主体支撑件100，使得主体支撑件100在预设温度下，如36℃时恢复至预设的形状，预设的形状可以根据实际需要进行设置，本申请不作限定。
连接波圈30可以设置在覆膜本体10的内侧，支撑波圈40可以设置在覆膜本体10的内侧或外侧，根据实际需要选择。当支撑波圈40设置在覆膜本体10的外侧时，支撑波圈40可以通过缝合或粘接的方式固定在覆膜本体10上。当支撑波圈40设置在覆膜本体10的内侧时，支撑波圈40可以通过缝合或粘接的方式固定在覆膜本体10上，也可以通过缝合或焊接的方式与连接波圈30固定连接。
本实施例中，连接波圈30设置在覆膜支架001的内侧，支撑波圈40设置在覆膜本体10与连接波圈30之间，支撑波圈40通过缝合的方式固定在覆膜本体10上，以增强覆膜本体10近端的支撑强 度，防止内漏。
其中，结合图1所示，支撑波圈40的丝径小于连接波圈30的丝径。由于覆膜支架001植入血管以后，支撑波圈40通过支撑覆膜本体10以使覆膜本体10贴合在血管内壁上，因此支撑波圈40的径向支撑力会直接影响覆膜支架001对血管内壁的压力。
本实施例通过将支撑波圈40的丝径设置为小于连接波圈30的丝径，从而降低支撑波圈40的径向支撑力，使得支撑波圈40与血管内壁的接触面更加柔软，对血管内壁刺激小，减少术后远期覆膜支架001近端并发支架源性新破口。在其他实施例中，还可以通过改变支撑波圈40和连接波圈30的材质，选择硬度更低的编织丝编织支撑波圈40，以使支撑波圈40的径向支撑力小于连接波圈30的径向支撑力。还可以通过加工工艺的改变，例如改变热处理的温度或时间等方式，调节支撑波圈40和连接波圈30的硬度。
其中，波圈的径向支撑力可以根据波圈的径向载荷的径向输出力得到，径向载荷的径向输出力(FR)等于波圈受到的径向压力(P)乘以波圈的截面积(A)，即P＝FR/A。其中，波圈的截面积为波圈受到径向压力的瞬时截面积。
具体可以参考标准号为ASTM F3067-14(2021)制定的径向载荷测试方法。
另一方面，如图9与图10所示，输送装置的释放机构60包括用于容纳与输送覆膜支架001的鞘管61以及设置在鞘管61内的鞘芯62，在将覆膜支架001输送至血管病变位置时，覆膜支架001装 载与鞘管61与鞘芯62之间，且覆膜支架001处于压缩状态。覆膜支架001的压缩状态如图12与图13所示。
由于本申请通过在覆膜本体10的近端边缘设置了支撑波圈40，通过支撑波圈40增强覆膜本体10的支撑强度，从而有效地防止血液渗漏。但是增加支撑波圈40会使覆膜支架001处于压缩状态的径向尺寸增大，为了顺利将覆膜支架001装入鞘管61中，鞘管61径向直径需要进行调整，以适应更大径向直径的覆膜支架001。
对于插入血管内的鞘管61而言，鞘管61的径向直径越小越有利于将覆膜支架001输送至病变位置。因此，本实施例将支撑波圈40的丝径设置为小于连接波圈30的丝径，不仅能够将支撑波圈40的径向支撑力减小，使得支撑波圈40与血管内壁的接触面更加柔软，还能够减小在覆膜支架001处于压缩状态时的径向尺寸，便于覆膜支架001装入较小径向尺寸的鞘管61中，从而有利于鞘管61将覆膜支架001输送至病变位置。
在本实施例中，连接波圈30和支撑波圈40通过缝合线缝合固定在覆膜本体10上。在测试连接波圈30和支撑波圈40的径向支撑力时，解除用于固定连接波圈30和支撑波圈40的缝合线，从覆膜本体10上取下连接波圈30和支撑波圈40，并对连接波圈30和支撑波圈40的径向支撑力进行测试，以保证支撑波圈40的径向支撑力小于连接波圈30的径向支撑力。
进一步地，结合图6至图8所示，支撑波圈40的波段数大于连接波圈30的波段数，其中，支撑波圈40包括若干依次连接的支撑 波形分段41，支撑波圈40的波段数为支撑波形分段41的数量，连接波圈30的波段数为固定波形分段32与活动波形分段31的总数量，而支撑波圈40的波段的数量设置为大于连接波圈30的波段的数量。
由于支撑波圈40设置在覆膜本体10与连接波圈30之间，且连接波圈30的径向支撑力大于支撑波圈40，因此在覆膜支架001完全释放以后，连接波圈30从内侧对支撑波圈40进行支撑。本实施例通过将支撑波圈40的波段数设置为大于连接波圈30的波段数，从而将连接波圈30提供的径向支撑力分散，使得血管内壁受到的压力更加均匀。另一方面，通过增加支撑波圈40的波段的数量，还可以使支撑波圈40与覆膜本体10近端的连接点更多，在支撑波圈40完全释放展开以后，覆膜本体10近端的形状更接近于圆形，从而进一步降低覆膜支架001发生内漏的风险。
具体的，支撑波圈40的丝径为0.1mm至0.5mm，连接波圈30的丝径为0.3mm至1mm，支撑波圈40的波段数为连接波圈30的波段数的2倍至5倍。在本实施例中，支撑波圈40的丝径为0.2mm，连接波圈30的丝径为0.5mm，支撑波圈40的波段数为连接波圈30的波段数的3倍，支撑波圈40和连接波圈30均通过镍钛丝制成。如图6与图7所示，连接波圈30包括若干依次连接的连接波段部301，若干连接波段部301依次收尾相连形成环状的支撑结构。连接波段部301若干固定波形分段32以及至少一个活动波形分段31，其中，包括固定波形分段32与覆膜本体10固定连接，活动波形分段31与覆膜本体10活动连接，通过活动波形分段31与覆膜支架001的释 放机构连接。
在本实施例中，连接波段部301包括三个与覆膜本体10活动连接的活动波形分段31，三个活动波形分段31沿覆膜本体10的周向方向均匀设置，也可以相邻设置或间隔设置，三个活动波形分段31用于连接输送装置的释放机构，在覆膜支架001完成定位后进行释放。
在其他实施例中，连接波段部301还可以包括四个或六个活动波形分段31，用于适配不同规格的输送装置的释放机构。
结合图9与图10所示，鞘芯62上设置有钩爪63，鞘芯62从覆膜支架001的内侧穿过且位于覆膜支架001的中部，钩爪63用于与连接波圈30进行连接，在覆膜支架001的输送过程中钩爪63与连接波的活动波形分段31钩挂固定，从而限制覆膜支架001在输送器内的位置，其中，鞘管61的前端还设置有引导部64，引导部64的前端呈锥形设置。
在覆膜支架001的释放过程中，当输送器将覆膜支架001输送到预定的位置后，通过解脱钩爪63与活动波形分段31的钩挂固定，从而将覆膜支架001完全释放到血管中。
钩爪63与活动波形分段31钩挂连接，当钩爪63解脱与活动波形分段31的连接后，覆膜支架001完全释放在血管中。在钩爪63解脱与活动波形分段31的连接前，覆膜支架001的近端因连接波圈30的结构设置，已处于半释放状态。其中，半释放状态指覆膜支架001的近端处于部分展开的状态。
在本实施例中，连接波圈30包括三个周向均匀分布的活动波形分段31。由于鞘芯62位于覆膜支架001内侧的中部，钩爪63设置在鞘芯62上，因此当活动波形分段31钩挂固定在钩爪63上时，钩爪63同时将三个活动波形分段31束缚在覆膜支架001内侧的中部。
固定波形分段32包括固定波峰321、固定波谷323以及连接相邻固定波峰321和固定波谷323的固定波杆322。活动波形分段31包括活动波峰311、活动波谷313以及连接相邻活动波峰311和活动波谷313的活动波杆312，活动波谷313与覆膜本体10固定连接，活动波峰311和活动波杆312与覆膜本体10活动连接。在本实施例中，固定波形分段32与活动波形分段31间隔设置。
在钩爪63解脱与活动波形分段31的连接前，活动波形分段31在钩爪63的束缚作用下，活动波峰311连接于钩爪63，活动波谷313连接于覆膜本体10，与活动波谷313连接的覆膜本体10在活动波形分段31的牵拉作用下，产生向覆膜支架001的内侧方向的位移。而固定波形分段32在自身弹性力的作用下对覆膜本体10产生向外侧的径向支撑力，从而将覆膜本体10撑开。
因此，在钩爪63解脱与活动波形分段31的连接前，固定波形分段32向外侧撑开覆膜本体10，而活动波形分段31向内侧牵拉覆膜本体10，使得覆膜支架001的前端形成半释放状态。其中，固定波峰321的顶部与覆膜本体10的近端边缘平齐，活动波峰311的顶部与覆膜本体10的近端边缘平齐，从而相较于突出覆膜本体10近端外的与输送装置的释放结构相连的裸支架相比，可减少覆膜本体 10对血管内壁的刺激。
本申请的技术方案中，采用了固定波峰321和活动波峰311的顶部边缘均与覆膜本体10的近端平齐的设置，取代了传统主动脉覆膜支架001的裸支架设置。从而在覆膜支架001释放后，不存在超出覆膜本体10近端的裸支架部分，因此避免了由于传统覆膜支架001的裸支架部分或倒刺对血管壁造成二次伤害的问题。在保护患者的动脉血管的同时，还能够避免由于覆膜支架001出现鸟嘴状结构导致漏血的问题，进一步提升覆膜支架001的密封性能。
具体地，当覆膜支架001植入在主动脉弓位置处时，覆膜支架001整体呈弯曲状设置，通常将覆膜支架001朝向主动脉弓的分支血管的一侧定义为覆膜支架001的大弯侧，将覆膜支架001背离主动脉弓的分支血管的一侧定义为覆膜支架001的小弯侧。在本申请中，凹槽部50设置在覆膜支架001的大弯侧。
进一步地，当主支架波圈20小弯侧的波段为主支架波峰21时，小弯侧的主支架波峰21与小弯侧的固定波峰321或活动波峰同轴且沿同一轴向方向设置。当主支架波圈20小弯侧的波段为主支架波谷23时，小弯侧的主支架波谷23与小弯侧的固定波谷323或活动波谷313同轴且沿同一轴向方向设置。本实施例通过上述设置，保证了覆膜支架001在植入主动脉弓对应位置处，小弯侧具有更好的顺应性。
即，当主支架波圈20位于正对凹槽部50的另一侧的波段为主支架波峰21时，位于正对所述凹槽部50的另一侧的主支架波峰21与位于正对所述凹槽部50的另一侧的固定波峰321或活动波峰311 方向相同，且在同一条轴线上。当主支架波圈20位于正对凹槽部50的另一侧的波段为主支架波谷23时，位于正对所述凹槽部50的另一侧的主支架波谷23与位于正对所述凹槽部50的另一侧的固定波谷323或活动波谷313方向相同，且在同一条轴线上。当主支架波圈20位于大弯侧的波段为主支架波峰21时，大弯侧主支架波峰21与大弯侧固定波谷323或活动波谷313方向相同，且在同一条轴线上。当主支架波圈20位于大弯侧的波段为主支架波谷23时，大弯侧主支架波谷23与大弯侧固定波峰321或活动波峰311方向相同，且在同一条轴线上。
本申请通过上述设置，保证了覆膜支架001在植入主动脉弓对应位置处，大弯侧具有更高的硬度，从而能够有效防止支架短缩。在本实施例中，位于覆膜支架001大弯侧的连接波圈部301为固定波形分段32。
具体的，连接波圈30的其中一个固定波峰321设置在凹槽部50的中线上，与连接波圈30相邻的主支架波圈20的一个主支架波峰21设置在凹槽部30的中线上，从而便于覆膜支架001植入主动脉弓位置后，具有更好的顺应性。其中，本实施例中凹槽部30的中线定义如下：凹槽部30与覆膜本体10相连接的边缘的两个顶点之间的连接线，其中顶点为距离覆膜支架001的中轴线最远的点。本实施例中，如图11所示，主支架波圈20位于大弯侧的波段的轴向高度大于小弯侧波段的轴向长度，从而大弯侧的相邻主支架波圈20之间的距离相比小弯侧的相邻主支架波圈20之间的距离更短。因此，覆 膜本体10的大弯侧不容易短缩，而小弯侧柔顺性更好。
在具体实施时，主支架波圈20的丝径D20为0.3至0.45mm，波高H20为6至15mm，波数T20为6至10个。例如，主支架波圈20的丝径D20为0.3mm，波高H20为8mm，波数T20为8个。连接波圈30的丝径D30为0.3至0.45mm，波高H30为10至15mm，波数T30为4至8个。例如，连接波圈30的丝径D30为0.4mm，波高H30为12mm，波数T30为6个。
两个相邻的主支架波圈20之间的间隔为1mm至2mm，最靠近连接波圈30的主支架波圈20与连接波圈30之间的间隔为1mm至2mm。连接波圈30与覆膜本体10固定连接的固定波谷323和活动波谷313均另外设置有缝合点33，缝合点33覆盖固定波谷323和活动波谷313的圆角，其中，缝合点33的轴向长度设置为大于0且小于等于5mm，以保证装配在输送器中的连接波圈30的固定波段32不会相对于覆膜本体10发生位移，进而避免连接波圈30在从输送器中释放出来后突出覆膜本体10。其中，缝合点采用缝线将固定波谷323和活动波谷313缝合在覆膜本体10上。
在其他实施例中，若连接波圈30与覆膜本体10固定连接的方式为粘接，则缝合点33还可以替换为粘接点。
如图8所示，支撑波圈40包括若干依次连接的支撑波形分段41，支撑波形分段41呈倒8字型设置或菱形设置，多个支撑波形分段41形成镍钛合金环，用于支撑覆膜本体10的近端。通过倒8字型或菱形的支撑波形分段41，增强支撑波圈40的支撑强度，以使覆膜支架 001的贴壁效果更好。其中，支撑波圈40的装配允许偏差也为±1mm，固定波峰321的装配允许偏差为±1mm。
在本实施例中，如图14所示，连接波段部301与支撑波形分段41在圆周方向上错位设置。具体的，连接波圈30相对于支撑波圈40相差半个相位设置，以使连接波圈30和支撑波圈40的整体对覆膜本体10具有更好的支撑性能。
需要说明的是，上述覆膜支架的尺寸参数设置仅仅是本实施的举例说明，适用于大多数应用场景，但不构成对本申请的限制，如有特殊尺寸要求，本申请的技术方案也可以采用其他尺寸参数。
支撑波圈40可以与覆膜本体10固定连接，支撑波圈40通过缝合或粘接固定的方式固定连接于覆膜本体10。支撑波圈40还可以与连接波圈30固定连接，支撑波圈40通过缝合、粘接或焊接的方式固定连接于连接波圈30。在本实施例中，支撑波圈40通过缝合的方式固定连接于覆膜本体10。
如图3与图5，所述支撑波圈40的近端与所述覆膜本体10的近端边缘平齐；或所述支撑波圈40的远端与所述连接波圈30的远端边缘平齐，且支撑波圈40的近端相较连接波圈30的近端更远离覆膜本体10的近端，便于连接波圈30与输送器的连接；或所述支撑波圈40设置在所述连接波圈30的远端与覆膜本体10的近端之间，以兼顾防止内漏和便于连接。
在本实施例中，支撑波圈40通过缝合的方式固定连接于覆膜本体10。支撑波圈40的近端波峰与覆膜本体10的近端边缘平齐，以 增强覆膜本体10近端的支撑强度，从而更好的防止内漏。
进一步地，由于支撑波圈40的近端波峰与覆膜本体10的近端边缘平齐，因此覆膜支架001在半释放状态时，覆膜本体10的近端边缘在支撑波圈40的径向支撑力作用下产生向外侧的位移，使得覆膜本体10的近端边缘在覆膜支架001完全释放前能够较大程度的靠近血管内壁。
在钩爪63解脱与波动波形分段的连接前，钩爪63将活动波形分段31的活动波峰311束缚在覆膜支架001的中部，因此在钩爪63解脱与活动波形分段31的束缚的瞬间，活动波形分段31会在自身的弹性力的作用下回弹，尤其是位于近端的活动波峰311的移动距离最大。活动波形分段31的回弹过程中，活动波形分段31会首先接触覆膜本体10，然后带动覆膜本体10接触血管内壁。
若覆膜本体10上未设置支撑波圈40，由于活动波形分段31在接触束缚的瞬间，会迅速地带动覆膜本体10贴靠在血管内壁上，对血管内壁造成冲击，导致病人不适，甚至导致血管痉挛。本实施例由于在覆膜本体10的近端设置了支撑波圈40，并且支撑波圈40的近端波峰与覆膜本体10的近端边缘平齐，使得覆膜本体10的近端边缘在覆膜支架001完全释放前能够较大程度的靠近血管内壁。因此，在活动波形分段31在接触束缚的瞬间，极大的化解了活动波形分段31，尤其是活动波峰311对血管内壁产生的冲击。
在其他实施例中，支撑波圈40还可以呈正弦波形设置、Z形波设置、M形波设置或者V形波设置。因此，本申请的上述支撑波圈 40的结构仅为示例，任何其他能够支撑覆膜本体10的结构均可应用于本申请。主体支撑件100和/或支撑覆膜10上设置有显影件，当显影件设置在主体支撑件100上时，例如显影件设置在主支架段200上时，显影件可以焊接、缝合或粘接在主支架段200上。当显影件设置在支撑覆膜10上时，显影件可以缝合或者粘接在支撑覆膜10上。
显影件设置有多个，显影件可以设置为O字型、8字型或N字型，即通过形状不同以进行区分。或者，显影件可以设置为黑度不同的显影点，即通过颜色深度不同进行区分。通过在覆膜支架001上设置多个显影件，从而方便医生等手术人员确定覆膜支架001的位置。
在本实施例中，显影件11设置在支撑覆膜10上，显影件11包括第一显影点111、第二显影点112以及第三显影点113，用于显示覆膜支架001的近端的位置以及凹槽部50的位置。其中，第一显影点111设置在凹槽部50的中线上，且第一显影点111设置在支撑架段300近端的边缘，第一显影点111可以设置在支撑架段300上或者设置在覆膜本体10上。第二显影点112设置在凹槽部50的中线上，且第二显影点112设置在相对凹槽部50靠近支撑架段300一端的边缘，第二显影点112设置在覆膜本体10上。第三显影点113设置在相对凹槽部50中线的另一侧，且第三显影点113设置在支撑架段300近端的边缘，第三显影点113可以设置在支撑架段300上或者设置在覆膜本体10上。
第一显影点111的形状与第二显影点112的形状不同，第一线 显影点的形状与第三显影点113的形状不同，第二显影点112的形状与第三显影点113的形状可以相同也可以不同。在本实施例中，第一显影点111呈8字型，第二显影点112和第三显影点113呈O字型。
其中，第一显影点111与第三显影点113用于显示覆膜支架001的近端位置，以及凹槽部50摆放的角度。第二显影点112用于显示凹槽部50的边缘的位置。
由于第一显影点111与第三显影点113均设置在支撑架段300近端的边缘，因此在覆膜支架001植入时，可以显示覆膜支架001的近端位置。并且，第一显影点111朝向主动脉弓的分支动脉的方向放置，第三显影点113背离主动脉弓的分支动脉的方向放置。由于第一显影点111与凹槽部50的设置朝向相同，因此还可以显示出凹槽部50摆放的角度。
其中，第一显影点111位于覆膜支架001大弯侧的近端边缘，指示覆膜支架001近端大弯侧的位置，第三显影点113位于覆膜支架001小弯侧的近端边缘，指示覆膜支架001小弯侧的位置。
本实施例中，如图15与图16所示，覆膜本体10上还设置有第八显影点118，第八显影点118设置在凹槽部50的中点上，且第八显影点118设置在相对凹槽部50远离支撑架段300的一端的边缘。其中，缝合圈53内设置的支撑环圈的两侧还可以设置显影条119，用于显示凹槽覆膜52的轮廓，从而便于植入覆膜支架001时的定位。
本实施例通过在覆膜支架001上设置第八显影点118和显影条 119，在术中可以指示凹槽部50的整体边缘位置，并可以指示导丝相对凹槽部50的相对位置，从而辅助医生确认导丝入路时，导丝位于凹槽内部，保证手术的成功率。
进一步地，当通孔521位于靠近支撑架段300的一端时，通孔521与支撑架段300近端之间的距离小于或等于第二显影点112与支撑架段300近端之间的距离，从而通过第二显影点112显示出凹槽部50边缘与通孔521之间的位置关系。
由于分支支架003通过通孔521缝合到凹槽部50，因此在缝合时可能存在通孔521与凹槽部50之间的缝合边，或者在设计时采用了缩进式的通孔521。因此，在上述情况下，将通孔521与支撑架段300近端之间的距离设置为小于第二显影点112与支撑架段300近端之间的距离。通过上述设置，医生在将导丝从凹槽部50通过通孔521穿入分支支架003时，能够准确的得知凹槽部50的边缘的位置，为医生的操作提供了便利。
综上，本申请与现有主动脉覆膜支架的连接波圈结构相比，连接波圈避免了裸露的连接波圈对锚定区血管内壁造成二次伤害，连接波圈30的活动波形分段31与覆膜本体10的半连接方式满足覆膜支架001后释放装置的配合使用。另外，支撑波圈40能起到加强支撑覆膜的作用，保证了覆膜支架001在释放后近端能完全贴壁，避免支架近端出现鸟嘴状而导致漏血。
实施例二，本申请的实施例二提供一种覆膜支架，如图17所示，本申请的实施例二与实施例一的相同之处不再赘述，实施例二与实 施例一的不同之处在于，相邻主支架波圈20之间通过连接杆24连接，多根连接杆24设置在与凹槽部50相同的一侧，多根连接杆24与凹槽部50的中线在同一条直线上，从而增加了覆膜支架001的支撑强度。其中，连接杆24与主支架波圈20之间通过钢套进行连接，或连接杆24焊接在主支架波圈20上。
需要理解的是，其他实施例中，多根连接杆24还可以错位设置，相邻两个主支架波圈20之间通过一个连接杆24进行连接，连接杆24设置在位于凹槽部50的同一侧即可。
本实施例通过在相邻主支架波圈20之间设置连接杆24，从而保证了覆膜支架001在植入后的弯曲方向，同时提高了覆膜支架001的支撑性。
实施例三，本申请的实施例三提供一种覆膜支架，如图18与图19所示，本申请的实施例三与实施例一的相同之处不再赘述，实施例三与实施例一的不同之处在于，活动波杆312与覆膜本体10呈预设角度设置。其中，活动波杆312朝向覆膜本体10的内侧弯折，预设角度大于0°且小于等于45°，例如30°。从而活动波峰311跟随活动波杆312朝向覆膜本体10的内侧弯折。活动波峰311与连接波圈30圆心之间的距离小于固定波峰321与连接波圈30圆心之间的距离。
由于未缝合的活动波形分段31在后释放过程之前存在径向的弹性力，因此在后释放过程中，朝向覆膜支架001外侧会产生一个回弹力。本实施例通过将于覆膜本体10活动连接的活动波杆312从根 部朝向覆膜支架001的内侧方向弯折，从而避免了活动波形分段31在后释放过程中回弹力对血管的冲击。相比于传统覆膜支架001的连接波圈设置，活动波杆312向内弯折，还可以减少活动波峰311长期顶在血管内壁，对血管内壁造成的长期刺激。
实施例四，本申请的实施例四提供一种覆膜支架，如图20与图21所示，本申请的实施例四与实施例二的相同之处不再赘述，实施例四与实施例三的不同之处在于，活动波杆312包括与活动波峰311连接的折弯部314，折弯部314与覆膜本体10呈预设角度设置。其中，折弯部314朝向覆膜本体10的内侧弯折，预设角度大于0°且小于等于45°，例如30°，折弯部314与活动波杆312的长度比大于等于30％小于等于60％。从而活动波峰311跟随折弯部314朝向覆膜本体10的内侧弯折。活动波峰311与连接波圈30圆心之间的距离小于固定波峰321与连接波圈30圆心之间的距离。
与实施例三相比，本实施例将活动波杆312近端的30％至60％区间长度设置为折弯部314。由于折弯部314是设置在活动波峰311与活动波谷313之间的，并且折弯部314靠近活动波峰311，因此活动波杆312在靠近活动波谷313根部的位置能够提供支撑力。
因此，本实施例在避免活动波形分段31在后释放过程中回弹力对血管的冲击外，还能够对覆膜本体10起到支撑作用，增强覆膜本体10的贴壁效果，进一步提高避免漏血的作用。相比于传统覆膜支架001的连接波圈设置，活动波杆312向内弯折，还可以减少活动波峰311长期顶在血管内壁，对血管内壁造成的长期刺激。
实施例五，本申请的实施例五提供一种覆膜支架，如图22所示，本申请的实施例五与实施例一的相同之处不再赘述，实施例五与实施例一的不同之处在于，支撑波圈40的形状与连接波圈30的形状相同，均为波浪形，且支撑波圈40与连接波圈30的呈错位设置，支撑波圈40与覆膜本体10完全固定。
在本实施例中，支撑波圈40与连接波圈30均为正弦波形，且支撑波圈40的位置为连接波圈30周向旋转半个周期所对应的位置，支撑波圈40通过缝合的方式与覆膜本体10固定。
支撑波圈40设置在覆膜本体10的外侧(此时在径向方向上，覆膜本体10位于连接波圈30与支撑波圈40之间)，或者在径向方向上，支撑波圈40设置在覆膜本体10的内侧，且支撑波圈40设置在覆膜本体10与连接波圈30之间，从而在保证连接波圈30的活动波形分段31能够连接到输送装置的释放机构的同时，保证覆膜本体10近端的支撑性，降低了血液内漏的风险，减小连接波圈30对血管的刺激。
实施例六，本申请的实施例六提供一种覆膜支架，如图23所示，本申请的实施例六与实施例一的相同之处不再赘述，实施例六与实施例一的不同之处在于，支撑波圈40包括若干独立的支撑单元42，每个独立的支撑单元42组合分布在连接波圈30的波峰与波谷之间。
本实施例的支撑波圈40包括若干周向均匀分布在连接波圈30的波峰与波谷之间的支撑单元42，支撑单元42为环形设置的圈体结构，且支撑单元42的近端与覆膜本体10的近端平齐。在本实施例 中，支撑单元42为菱形，且菱形的长轴平行于覆膜支架的纵向中心轴。其他实施例中，支撑单元42可以为椭圆形，且其长轴平行于覆膜支架的纵向中心轴。
通过设置长轴平行于覆膜支架的纵向中心轴的菱形或者椭圆形的支撑单元42，从而在减少覆膜支架的压缩后的径向尺寸及提高了覆膜本体10近端的强度之间达到一个平衡，使得覆膜本体10近端不仅支撑性更好，降低了血液内漏的风险，而且径向压缩后的尺寸较小。
实施例七，本申请的实施例七提供一种覆膜支架，如图24所示，本申请的实施例七与实施例一的相同之处不再赘述，实施例七与实施例一的不同之处在于，连接波圈30包括若干依次连接的连接波段部301，连接波段部301包括依次间隔设置的固定波形分段32和活动波形分段31，连接波段部301均设置在覆膜本体10的内表面。
固定波形分段32呈环形设置，固定波形分段32完全固定连接于覆膜本体10，活动波形分段31设置在相邻固定波形分段32之间，活动波形分段31呈条形设置，活动波形分段31活动连接于覆膜本体10。
具体的，活动波形分段31朝向覆膜本体10的近端凸起，形成用于连接到输送装置的释放机构的活动波峰311，活动波峰311的近端与覆膜本体10的近端齐平或活动波峰311的内部(也就是说，活动波峰311相较覆膜本体10近端更靠近覆膜本体10的远端)。活动波峰311的两侧分别设置有活动波杆312，两侧活动波杆312分别 与对应侧的固定波形分段32固定连接。
固定波形分段32通过缝合与覆膜本体10固定连接，活动波形分段31通过焊接与固定波形分段32连接。
本实施例通过位于覆膜本体10内部的活动波峰311与输送装置的释放结构相连接，从而减少活动波峰311对血管内壁的刺激的同时，完成释放支架的目的。
实施例八，本申请的实施例八提供一种覆膜支架，如图25所示，本申请的实施例八与实施例七的相同之处不再赘述，实施例八与实施例七的不同之处在于，活动波形分段31呈环形设置，活动波形分段31部分固定连接于覆膜本体10，部分与覆膜本体10相分离。固定波形分段32设置在相邻活动波形分段31之间，固定波形分段32呈条形设置，且固定波形分段32完全固定连接于覆膜本体10，固定波形分段32可以为直线段形状，也可以为曲线段形状。
具体的，活动波形分段31包括靠近覆膜本体10近端的一侧且活动连接于覆膜本体10的活动近端部316，以及远离覆膜本体10近端的一侧且固定连接于覆膜本体10的活动远端部315。活动近端部316与覆膜本体10的近端齐平，或活动近端部316与覆膜本体10之间设置预定的缩进距离。其中，预定的缩进距离为0.5mm至2mm，通过设置预定的缩进距离，使得活动近端部316与覆膜本体10之间具有足够的安装间隙，从而保证活动近端部316与覆膜本体10之间不会脱离。
本实施例通过位于活动波形分段31近端的活动近端部316与输 送装置的释放结构相连接，实现将连接波圈30收纳于覆膜本体10内部以减少裸支架对血管内壁的刺激的同时，完成释放支架的目的。
实施例九，本申请的实施例九提供一种覆膜支架，如图26与图27所示，本申请的实施例九与实施例一的相同之处不再赘述，实施例九与实施例一的不同之处在于，结合图1所示，显影件11还包括设置在覆膜本体10上的第四显影点114以及第五显影点115，第四显影点114和第五显影点115分别设置覆膜本体10靠近凹槽部50近端的两侧。
其中，第四显影点114和第五显影点115分别设置在凹槽覆膜52近端的两侧，用于指示凹槽覆膜52近端两侧的位置。本实施例通过第四显影点114和第五显影点115，使得医生能够准确得知位于凹槽部50底端的凹槽覆膜52的近端的位置，为医生的观察和操作提供便利。
进一步地，本实施例中，凹槽部50的凹槽覆膜52上还设置有第六显影点116和第七显影点117，第六显影点116和第七显影点117分别设置在凹槽覆膜52近端和远端的中部。
其中，第一显影点111与第三显影点113的形状不同，第六显影点116的形状与第二显影点112的形状不同，第七显影点117与第八显影点118的形状不同，从而更明显的对各显影点进行区分。
本实施例通过设置第六显影点116和第七显影点117，在术中可以指示凹槽部50近端和远端内嵌的分支支架003的深度，并通过与第八显影点118配合，辅助医生在确认导丝入路时，找到内嵌的分 支支架003的位置，为医生操作提供便利，提高手术成功率和效率。综上所述，本申请提供了一种覆膜支架，与现有主动脉覆膜支架的连接波圈结构相比，避免了裸露的连接波圈对锚定区血管内壁造成二次伤害，连接波圈的活动波形分段与覆膜本体的半连接方式满足覆膜支架后释放装置的配合使用。
以上，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。

Claims (40)

  1. 一种覆膜支架，包括主体支撑件以及设置在所述主体支撑件上的覆膜本体，其特征在于，所述主体支撑件包括主支架段以及设置在所述主支架段近端的支撑架段，所述支撑架段包括与所述覆膜本体部分连接的连接波圈，所述连接波圈包括若干与所述覆膜本体固定连接的固定波形分段以及至少一个与所述覆膜本体活动连接的活动波形分段。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述固定波形分段与所述活动波形分段依次间隔设置。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述固定波形分段包括固定波峰、固定波谷以及连接相邻所述固定波峰和固定波谷的固定波杆，所述固定波峰的顶部与所述覆膜本体的近端边缘平齐；
    所述活动波形分段包括活动波峰、活动波谷以及连接相邻所述活动波峰和活动波谷的活动波杆，所述活动波谷与所述覆膜本体固定连接，所述活动波峰以及所述活动波杆与所述覆膜本体活动连接。
  4. 根据权利要求3所述的覆膜支架，其特征在于，所述活动波杆与所述覆膜本体呈预设角度设置；或所述活动波杆包括与所述活动波峰连接的折弯部，所述折弯部与所述覆膜本体呈预设角度设置。
  5. 根据权利要求4所述的覆膜支架，其特征在于，所述活动波杆朝向所述覆膜本体的内侧弯折，或所述折弯部朝向所述覆膜本体的内侧弯折，所述预设角度大于0°且小于等于45°，所述折弯部的长度与所述活动波杆的长度之比的百分率大于或等于30％且小于 或等于60％。
  6. 根据权利要求1所述的覆膜支架，其特征在于，所述支撑架段还包括设置在所述支撑覆膜端口处的支撑波圈，所述支撑波圈的丝径小于所述连接波圈的丝径。
  7. 根据权利要求6所述的覆膜支架，其特征在于，所述支撑波圈的波段数大于所述连接波圈的波段数。
  8. 根据权利要求6所述的覆膜支架，其特征在于，所述支撑波圈与所述覆膜本体固定连接，或所述支撑波圈与所述连接波圈固定连接。
  9. 根据权利要求8所述的覆膜支架，其特征在于，所述支撑波圈的近端与所述覆膜本体的近端边缘平齐，或所述支撑波圈的远端与所述连接波圈的远端边缘平齐，或所述支撑波圈设置在所述连接波圈的远端与覆膜本体的近端之间。
  10. 根据权利要求1-9任一项所述的覆膜支架，其特征在于，所述主体支撑件上设置有朝向所述主体支撑件内侧凹陷的凹槽部，所述凹槽部包括与所述主体支撑件连接的凹槽支撑件以及设置在凹槽支撑件上的凹槽覆膜；所述主体支撑件和/或所述支撑覆膜上设置有显影件。
  11. 一种覆膜支架，包括主体支撑件以及设置在所述主体支撑件上的覆膜本体，其特征在于，所述主体支撑件包括主支架段以及设置在所述主支架段近端的支撑架段，所述支撑架段包括与所述覆膜本体部分连接的连接波圈以及设置在所述支撑覆膜端口处的支撑 波圈，所述支撑波圈的丝径小于所述连接波圈的丝径。
  12. 根据权利要求11所述的覆膜支架，其特征在于，所述支撑波圈的波段数大于所述连接波圈的波段数。
  13. 根据权利要求11所述的覆膜支架，其特征在于，所述支撑波圈与所述覆膜本体固定连接，或所述支撑波圈与所述连接波圈固定连接。
  14. 根据权利要求13所述的覆膜支架，其特征在于，所述支撑波圈的近端与所述覆膜本体的近端边缘平齐，或所述支撑波圈的远端与所述连接波圈的远端边缘平齐，或所述支撑波圈设置在所述连接波圈的远端与覆膜本体的近端之间。
  15. 根据权利要求11所述的覆膜支架，其特征在于，所述连接波圈包括若干与所述覆膜本体固定连接的固定波形分段以及至少一个与所述覆膜本体活动连接的活动波形分段。
  16. 根据权利要求15所述的覆膜支架，其特征在于，所述固定波形分段与所述活动波形分段依次间隔设置。
  17. 根据权利要求15所述的覆膜支架，其特征在于，所述固定波形分段包括固定波峰、固定波谷以及连接相邻所述固定波峰和固定波谷的固定波杆，所述固定波峰的顶部与所述覆膜本体的近端边缘平齐；
    所述活动波形分段包括活动波峰、活动波谷以及连接相邻所述活动波峰和活动波谷的活动波杆，所述活动波谷与所述覆膜本体固定连接，所述活动波峰以及所述活动波杆与所述覆膜本体活动连接。
  18. 根据权利要求17所述的覆膜支架，其特征在于，所述活动波杆与所述覆膜本体呈预设角度设置；或所述活动波杆包括与所述活动波峰连接的折弯部，所述折弯部与所述覆膜本体呈预设角度设置。
  19. 根据权利要求18所述的覆膜支架，其特征在于，所述活动波杆朝向所述覆膜本体的内侧弯折，或所述折弯部朝向所述覆膜本体的内侧弯折，所述预设角度大于0°且小于等于45°，所述折弯部的长度与所述活动波杆的长度之比的百分率大于或等于30％且小于或等于60％。
  20. 根据权利要求11-19任一项所述的覆膜支架，其特征在于，所述主体支撑件上设置有朝向所述主体支撑件内侧凹陷的凹槽部，所述凹槽部包括与所述主体支撑件连接的凹槽支撑件以及设置在凹槽支撑件上的凹槽覆膜；所述主体支撑件和/或所述支撑覆膜上设置有显影件。
  21. 一种覆膜支架，包括主体支撑件以及设置在所述主体支撑件上的覆膜本体，其特征在于，所述主体支撑件包括主支架段以及设置在所述主支架段近端的支撑架段，所述支撑架段包括与所述覆膜本体部分连接的连接波圈以及设置在所述支撑覆膜端口处的支撑波圈，所述主体支撑件上设置有朝向所述主体支撑件内侧凹陷的凹槽部。
  22. 根据权利要求21所述的覆膜支架，其特征在于，所述凹槽部包括与所述主体支撑件连接的凹槽支撑件以及设置在凹槽支撑件 上的凹槽覆膜，所述凹槽部上设置有至少一个用于连接分支支架的通孔。
  23. 根据权利要求22所述的覆膜支架，其特征在于，所述主体支撑件和/或所述支撑覆膜上设置有显影件，所述显影件包括设置在所述凹槽部中线上的第一显影点和第二显影点，以及设置在相对于凹槽部中线另一侧的第三显影点；所述第一显影点和所述第三显影点位于所述支撑架段近端的边缘，所述第二显影点位于所述凹槽部靠近所述支撑架段一端的边缘。
  24. 根据权利要求23所述的覆膜支架，其特征在于，当所述通孔位于靠近所述支撑架段的一端时，所述通孔与所述支撑架段近端之间的距离小于或等于所述第二显影点与所述支撑架段近端之间的距离。
  25. 根据权利要求21所述的覆膜支架，其特征在于，所述支撑波圈的丝径小于所述连接波圈的丝径，所述支撑波圈的波段数大于所述连接波圈的波段数，所述支撑波圈与所述覆膜本体固定连接，或所述支撑波圈与所述连接波圈固定连接。
  26. 根据权利要求21所述的覆膜支架，其特征在于，所述支撑波圈的近端与所述覆膜本体的近端边缘平齐，或所述支撑波圈的远端与所述连接波圈的远端边缘平齐，或所述支撑波圈设置在所述连接波圈的远端与覆膜本体的近端之间。
  27. 根据权利要求21所述的覆膜支架，其特征在于，所述连接波圈包括若干与所述覆膜本体固定连接的固定波形分段以及至少一 个与所述覆膜本体活动连接的活动波形分段，所述固定波形分段与所述活动波形分段依次间隔设置。
  28. 根据权利要求27所述的覆膜支架，其特征在于，所述固定波形分段包括固定波峰、固定波谷以及连接相邻所述固定波峰和固定波谷的固定波杆，所述固定波峰的顶部与所述覆膜本体的近端边缘平齐；
    所述活动波形分段包括活动波峰、活动波谷以及连接相邻所述活动波峰和活动波谷的活动波杆，所述活动波谷与所述覆膜本体固定连接，所述活动波峰以及所述活动波杆与所述覆膜本体活动连接。
  29. 根据权利要求28所述的覆膜支架，其特征在于，所述主支架段包括若干间隔设置的主支架波圈，所述主支架波圈包括主支架波峰、主支架波谷以及连接主支架波峰和主支架波谷的主支架连杆；
    所述主支架波圈之间通过覆膜本体连接。
  30. 根据权利要求29所述的覆膜支架，其特征在于，所述主体支撑件上设置有朝向所述主体支撑件内侧凹陷的凹槽部；所述主体支撑件的大弯侧设置有固定波形分段。
  31. 一种覆膜支架，包括主体支撑件以及设置在所述主体支撑件上的覆膜本体，其特征在于，所述主体支撑件包括主支架段以及设置在所述主支架段近端的支撑架段，所述支撑架段包括与所述覆膜本体部分连接的连接波圈以及设置在所述支撑覆膜端口处的支撑波圈，所述连接波圈的径向支撑力大于所述支撑波圈的径向支撑力。
  32. 根据权利要求31所述的覆膜支架，其特征在于，所述连接 波圈的丝径大于所述支撑波圈的丝径，所述支撑波圈的波段数大于所述连接波圈的波段数。
  33. 根据权利要求31所述的覆膜支架，其特征在于，所述支撑波圈与所述覆膜本体固定连接，或所述支撑波圈与所述连接波圈固定连接。
  34. 根据权利要求33所述的覆膜支架，其特征在于，所述支撑波圈的近端与所述覆膜本体的近端边缘平齐，或所述支撑波圈的远端与所述连接波圈的远端边缘平齐，或所述支撑波圈设置在所述连接波圈的远端与覆膜本体的近端之间。
  35. 根据权利要求31所述的覆膜支架，其特征在于，所述连接波圈包括若干与所述覆膜本体固定连接的固定波形分段以及至少一个与所述覆膜本体活动连接的活动波形分段。
  36. 根据权利要求35所述的覆膜支架，其特征在于，所述固定波形分段与所述活动波形分段依次间隔设置。
  37. 根据权利要求35所述的覆膜支架，其特征在于，所述固定波形分段包括固定波峰、固定波谷以及连接相邻所述固定波峰和固定波谷的固定波杆，所述固定波峰的顶部与所述覆膜本体的近端边缘平齐；
    所述活动波形分段包括活动波峰、活动波谷以及连接相邻所述活动波峰和活动波谷的活动波杆，所述活动波谷与所述覆膜本体固定连接，所述活动波峰以及所述活动波杆与所述覆膜本体活动连接。
  38. 根据权利要求37所述的覆膜支架，其特征在于，所述活动 波杆与所述覆膜本体呈预设角度设置；或所述活动波杆包括与所述活动波峰连接的折弯部，所述折弯部与所述覆膜本体呈预设角度设置。
  39. 根据权利要求38所述的覆膜支架，其特征在于，所述活动波杆朝向所述覆膜本体的内侧弯折，或所述折弯部朝向所述覆膜本体的内侧弯折，所述预设角度大于0°且小于等于45°，所述折弯部的长度与所述活动波杆的长度之比的百分率大于或等于30％且小于或等于60％。
  40. 根据权利要求31-99任一项所述的覆膜支架，其特征在于，所述主体支撑件上设置有朝向所述主体支撑件内侧凹陷的凹槽部，所述凹槽部包括与所述主体支撑件连接的凹槽支撑件以及设置在凹槽支撑件上的凹槽覆膜；所述主体支撑件和/或所述支撑覆膜上设置有显影件。
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CN116712229B (zh) * 2023-08-10 2024-01-12 北京华脉泰科医疗器械股份有限公司 覆膜支架输送系统

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