WO2020259709A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2020259709A1
WO2020259709A1 PCT/CN2020/099011 CN2020099011W WO2020259709A1 WO 2020259709 A1 WO2020259709 A1 WO 2020259709A1 CN 2020099011 W CN2020099011 W CN 2020099011W WO 2020259709 A1 WO2020259709 A1 WO 2020259709A1
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WO
WIPO (PCT)
Prior art keywords
elastic support
developing
stent graft
support member
graft according
Prior art date
Application number
PCT/CN2020/099011
Other languages
English (en)
French (fr)
Inventor
肖本好
刘彩萍
Original Assignee
深圳市先健畅通医疗有限公司
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 CN201910570287.4A external-priority patent/CN110420075B/zh
Priority claimed from CN201910569085.8A external-priority patent/CN110420074B/zh
Application filed by 深圳市先健畅通医疗有限公司 filed Critical 深圳市先健畅通医疗有限公司
Priority to US17/617,885 priority Critical patent/US11806225B2/en
Publication of WO2020259709A1 publication Critical patent/WO2020259709A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/02—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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the technical field of interventional medical devices, in particular to a covered stent.
  • aortic stent grafts have been widely used in thoracic and abdominal aortic aneurysms and arterial dissections. It has proven curative effect, small trauma, fast recovery, and fewer complications, and has become the first line Treatment methods.
  • the stent graft is delivered to the lesion location through the corresponding delivery system.
  • the stent graft isolates the blood flow from the lesion location and eliminates the influence of blood pressure on the lesion location to achieve the purpose of healing. Due to the complex vascular structure of the human body, there are many branches of arteries.
  • stent grafts For special lesions such as the aortic arch, celiac trunk, bilateral renal arteries or superior mesenteric artery, the use of stent grafts will affect the blood supply of the arterial branches. In view of this situation, it is necessary to set the expected hole on the stent graft and establish a guide wire track from the hole of the stent graft to the arterial branch vessel. This requires that the edge of the hole has good visibility and support to ensure The guide wire can pass through the hole smoothly, thereby establishing a guide wire track.
  • the existing stent grafts generally have 4 development points on the edge of the hole, namely, one for each of the top, bottom, left, and right. Due to the small distribution of the development points, it is difficult to accurately determine the position of the edge of the hole when the guide wire track is established, and the guide wire cannot pass smoothly. The hole causes the operation time to be prolonged.
  • the technical problem to be solved by the present invention is to provide a stent graft in view of the above-mentioned defects in the prior art.
  • a stent graft comprising a hollow tubular body, and a window provided on the side wall of the tubular body, an elastic support is provided on the periphery of the window, and a developer is provided on the elastic support, so At least a part of the developing member is movably connected with the elastic support member.
  • the developing member is spirally wound on the outer surface of the elastic support member.
  • the developing member includes a plurality of spiral units wound on the elastic support member, and the spiral unit includes two connected connecting parts, and the connecting parts are connected to the elastic support.
  • the angle between the tangent corresponding to the intersection of the support and the center line of the connecting portion is 75°-90°.
  • the elastic support member has an open-loop structure, and in a natural state, the two ends of the elastic support member at least partially overlap.
  • the overlapping part of the two ends of the elastic support is located in the middle region of the elastic support.
  • the elastic support member and the developing member are covered with a wrapping member.
  • a spacer is provided between the elastic support member and the developing member.
  • a mounting groove is provided on the elastic support member, and the developing member is movably connected in the mounting groove; or, the developing member includes a plurality of ring-shaped The developing unit is movably sleeved outside the elastic support.
  • the developing member includes at least one developing section, and the developing section includes a movable part movably connected to the elastic support member, and a fixed part fixedly connected to the elastic support member
  • the fixing part is located outside the proximal and distal regions of the elastic support.
  • the developing member includes two developing sections, and the two developing sections are symmetrically arranged along the line connecting the proximal end and the distal end of the elastic support member, and the developing section is It is spirally wound on the outer surface of the elastic support, and the developing section is entirely located outside the proximal and distal regions of the elastic support.
  • a stent graft comprising a hollow tubular body, and a window provided on the side wall of the tubular body, an elastic support is provided on the periphery of the window, and a developer is provided on the elastic support, so
  • the developing member includes a fixing portion fixedly connected to the elastic support member, and the fixing portion is located outside the proximal and distal regions of the elastic support.
  • the developing member includes at least one developing section, the developing section is spirally wound on the outer surface of the elastic support member, the developing section includes the fixing portion, and A movable part movably connected with the elastic support.
  • the fixing portion is located at both ends of the developing section.
  • the entire imaging section is located outside the proximal and distal regions of the elastic support.
  • the developing section includes a plurality of spiral units wound on the elastic support, and the spiral unit includes two connected connecting parts, and the connecting parts are connected to the elastic support.
  • the angle between the tangent corresponding to the intersection of the support and the center line of the connecting portion is 75°-90°.
  • the elastic support member has an open-loop structure, and in a natural state, the two ends of the elastic support member at least partially overlap.
  • the overlapping part of the two ends of the elastic support is located in the middle region of the elastic support.
  • the elastic support member and the developing member are covered with a wrapping member.
  • a spacer is provided between the elastic support member and the developing member.
  • the stent graft implementing the present invention has the following effects: since the developing member and the elastic supporting member are located on the periphery of the window, the developing member and the elastic supporting member can make the periphery of the window have good developability at the same time And supportive. In addition, since the developing member is movably connected to the elastic support member, when bending deformation occurs, the developing member and the elastic support member can move relatively, so that the developing member can be moved away from the area where the elastic support member has a large amount of deformation, and the developing member is prevented from being significantly bent .
  • Fig. 1 is a schematic diagram of a stent graft provided by one embodiment of the present invention
  • FIG. 2 is a schematic diagram of a developing member and an elastic support member around the window of the stent graft shown in FIG. 1;
  • Figure 3 is a schematic diagram of the elastic support shown in Figure 2 in an open-loop structure
  • FIG. 4a and 4b are schematic diagrams of the spiral unit of the developing member shown in FIG. 2;
  • 5a and 5b are comparison diagrams of the spiral unit of the developing member shown in FIG. 2;
  • Figure 6 is a schematic diagram of the elastic support shown in Figure 2 in a closed loop structure
  • Fig. 7a is a schematic diagram of a spherical part provided at the end of the elastic support shown in Fig. 2;
  • Fig. 7b is a schematic diagram of a ring structure provided at the end of the elastic support shown in Fig. 2;
  • FIG. 8 is a schematic diagram of the developing member and the elastic supporting member around the window of the stent graft provided by the second embodiment of the present invention.
  • FIG. 9 is a schematic diagram of the developing member and the elastic supporting member around the window of the stent graft provided by the third embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the developing member and the elastic supporting member around the window of the stent graft provided by the fourth embodiment of the present invention.
  • FIG. 11 is a schematic diagram of the developing member and the elastic support member around the window of the stent graft provided by the fifth embodiment of the present invention.
  • the end of the stent graft that is closer to the heart after release is usually defined as the proximal end, and the end farther from the heart is the distal end.
  • one of the embodiments of the present application provides a stent graft 100, including a hollow tubular body 10, and a window 20 provided on the side wall of the tubular body 10, the lumen of the tubular body 10 constitutes a blood flow aisle.
  • the tubular body 10 includes a bare stent 101 and a covering film 102 connected to the bare stent 101.
  • the bare stent 101 is made of materials with good biocompatibility, such as nickel-titanium, stainless steel and other materials.
  • the bare stent 101 includes a multi-turn wave-shaped ring 1011, and the multi-turn wave-shaped ring 1011 is sequentially spaced from the proximal end to the distal end, or connected in a grid-like structure.
  • the covering film 102 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET, etc.
  • an elastic support 30 is provided on the periphery of the window 20, a developing member 40 is provided on the elastic support 30, and the developing member 40 is movably connected to the elastic support 30.
  • the elastic support 30 will undergo significant bending deformation, especially its proximal and distal regions. Since the developing member 40 is movably connected with the elastic supporting member 30, when bending deformation occurs, the developing member 40 and the elastic supporting member 30 can move relatively, so that the developing member 40 can move away from the area where the elastic supporting member 30 has a large amount of deformation and avoid developing The piece 40 is significantly bent.
  • the developing member 40 and the elastic support member 30 are both located on the periphery of the window 20, the developing member 40 and the elastic support member 30 can make the periphery of the window 20 have good developability and support.
  • the elastic support 30 is made of a material with a larger elastic modulus, such as Nitinol, so that the periphery of the window 20 has good compression and resilience characteristics.
  • the developing member 40 is made of a material with X-ray opacity and good biocompatibility, such as gold, tantalum-niobium alloy, platinum-iridium alloy, etc., so that the periphery of the window 20 has good developability, but this type of material
  • the modulus of elasticity is smaller, resulting in that the modulus of elasticity of the developing member 40 is smaller than that of the elastic support member 30.
  • the developing member 40 Since the elastic modulus of the developing member 40 is relatively small, when deformed, the developing member 40 is prone to plastic deformation, thereby limiting the resilience of the elastic support member 30 connected to it, resulting in the window 20 not being fully opened, and the opening size of the window 20 Decrease, thereby affecting the establishment of the guide wire track. Since the developing member 40 of the present application is movably connected with the elastic support member 30, when deformation occurs, the developing member 40 can move on the elastic support member 30 and move to a position where the deformation amount of the elastic support member 30 is small, avoiding the developing member 40 Plastic deformation occurs.
  • the elastic support 30 is an open-loop structure. When it is in a natural state, the two ends of the elastic support 30 at least partially overlap. At this time, the elastic support 30 covers the entire periphery of the window 20 and can completely support the shape of the window 20. Since the elastic support 30 has an open-loop structure, when elastic deformation occurs, the two ends of the elastic support 30 can move relatively, which facilitates the radial compression and springback deformation of the elastic support 30.
  • the overlapping portions of the two ends of the elastic support 30 are located at or near the proximal and distal regions of the elastic support 30, when deformation occurs, The end of the elastic support 30 easily protrudes from the spiral gap of the developing section 44, which affects the subsequent relative movement of the two. Therefore, in order to prevent the relative movement between the two ends of the elastic support 30 from being affected by the bending deformation, the overlapping part of the two ends of the elastic support 30 is located in the middle area of the elastic support 30.
  • the “middle area of the elastic support member” herein refers to the area covered by the point on the elastic support member 30 whose vertical distance from the proximal end and the distal end thereof is greater than or equal to 2 mm.
  • the elastic support 30 has an elliptical shape, the long axis m is approximately along the direction parallel to the generatrix of the stent graft 100, and the short axis n is approximately along the direction perpendicular to the generatrix of the stent graft 100. Due to the relatively small size of the short axis n, when the stent graft 100 is compressed into the sheath, the elastic support 30 is more likely to be radially compressed, and the resilient force generated in the sheath is small, which is also beneficial to reduce the resistance during release . In this embodiment, the ratio of the long axis m to the short axis n of the elastic support 30 satisfies 3/2 ⁇ m/n ⁇ 3, so as to facilitate the radial compression and springback deformation of the elastic support 30.
  • the developing member 40 is spirally wound on the entire outer surface of the elastic supporting member 30.
  • the inner diameter of the spiral structure enclosed by the developing member 40 is larger than the outer diameter of the elastic supporting member 30, so that the developing member 40 can be moved. It is sleeved outside the elastic support 30, and when the elastic support 30 is elastically deformed, the two ends of the elastic support 30 are always located in the spiral structure enclosed by the developing member 40.
  • the diameter of the inscribed circle of the cross section of the developing wire constituting the developing member 40 is greater than or equal to 0.1 mm, preferably 0.1 mm to 0.5 mm, to ensure that the developing member 40 has good developability. It can be understood that, in other embodiments, the developing member 40 may only be wound on a part of the outer surface of the elastic support member 30.
  • the developing member 40 includes a number of spiral units 41 wound on the elastic support 30, the spiral unit 41 includes two connected connecting parts 410, respectively a first connecting part 410a and a second connecting part 410b.
  • the angle between the tangent b corresponding to the intersection point of the connecting portion 410 and the elastic support 30 and the center line a of the connecting portion 410 is ⁇ , 75° ⁇ 90°.
  • the above-mentioned included angle ⁇ is set in the range of 75° to 90°, so that the relative movement between the developing member 40 and the elastic support member 30 is not affected by bending deformation, and at the same time, the developing member 40 is prevented from plastic deformation.
  • the elastic support 30 may also be a closed-loop structure or an annular structure, etc., as long as the elastic support 30 and the developing member 40 are ensured Active connection is fine.
  • the elastic support 30 is an elliptical closed loop structure.
  • the elastic support 30 is an elliptical open-loop structure. In a natural state, the two ends of the elastic support 30 at least partially overlap, and the elastic support 30 Both ends are provided with spherical portions 31 or ring structures 32, and the developing member 40 is spirally wound on the outer surface of the elastic support member 30.
  • the radial dimension of the spherical portion 31 and the annular structure 32 is larger than the gap between two adjacent first connecting portions 410a (or second connecting portions 410b), so as to avoid elasticity when the developing member 40 and the elastic supporting member 30 move relatively.
  • the ends of the supporting member 30 pass through the gap of the developing member 40 to ensure that the two ends of the elastic supporting member 30 are always located in the spiral structure enclosed by the developing member 30.
  • the elastic supporting member 30 and the developing member 40 are made of metal materials, there is a potential difference between the two, if they are in direct contact with blood, electrochemical corrosion and chemical corrosion are likely to occur, causing the elastic supporting member 30 and the developing member 40 to break.
  • the broken elastic supporting member 30 or the developing member 40 enters the body to circulate and may cause serious injury to the patient. Therefore, when assembling, the elastic supporting member 30 connected with the developing member 40 can be put into a hollow package (not shown), and then the package can be fixed on the periphery of the window 20.
  • the wrapper has a ring structure, which is made of a polymer material with good biocompatibility, preferably blood impermeable PTFE, ePTFE, etc.
  • the elastic support 30 can be movably placed in the package, and the package does not affect the movable connection between the elastic support 30 and the developer 40. Since the wrapper wraps the elastic support 30 and the developing member 40, even if the elastic support 30 or the developing member 40 is broken, the broken structure will not enter the human body and cause harm to the patient.
  • the elastic support 30 connected with the developing member 40 is placed on the periphery of the window 20, and then the covering film 102 around the window 20 is turned toward the side of the elastic support 30 Fold and wrap the elastic support 30 in it, and finally fix the covering film 102 on the inner and outer sides of the elastic support 30.
  • the package of this embodiment is formed by folding the covering film 102 around the window 20.
  • the present embodiment does not limit the specific structure of the wrapping member, as long as it can wrap the elastic support member 30 and the developing member 40 without affecting the movable connection between the two.
  • the wrapper and the covering film 102 are both independent components, and the wrapper is fixed on the periphery of the window 20 by stitching.
  • a spacer (not shown) is arranged between the elastic support member 30 and the developing member 40 of the present application, and the spacer is made of a material with good biocompatibility, such as PTFE, FEP, PET, etc. Separating the elastic support member 30 from the developing member 40 by the spacer can not only avoid friction caused by direct contact between the two, but also avoid the occurrence of electrochemical corrosion and chemical corrosion.
  • the spacer is covered on the entire outer surface of the elastic support 30 by stitching or heat treatment, and the developing part 40 is movably sleeved outside the spacer.
  • the position of the spacer on the elastic support 30 is not limited in this embodiment.
  • the spacer can only be wrapped around the two ends of the elastic support 30. Since the elastic support 30 has an open-loop structure, the relative friction between the two ends of the elastic support 30 is relatively large. The two ends of the elastic support 30 are covered with spacers, which can effectively avoid the two ends of the elastic support 30. Department fracture.
  • the second preferred embodiment of the present application provides a stent graft.
  • the difference from the first embodiment is that the elastic support 30 is provided with a mounting groove 35, and the developing member 40 is movable Connected in the installation groove 35.
  • the developing member 40 includes a plurality of spherical first developing units 45, and the first developing units 45 can roll in the mounting groove 35.
  • the developing member 40 and the elastic support member 30 can move relatively, so that the developing member 40 is moved away from the area where the elastic support member 30 has a large amount of deformation, so as to prevent the developing member 40 from affecting the pressing and returning of the elastic support member 30.
  • Elastic deformation When bending deformation occurs, the developing member 40 and the elastic support member 30 can move relatively, so that the developing member 40 is moved away from the area where the elastic support member 30 has a large amount of deformation, so as to prevent the developing member 40 from affecting the pressing and returning of the elastic support member 30. Elastic deformation.
  • the third preferred embodiment of the present application provides a stent graft.
  • the developing member 40 includes a plurality of second developing units 46 in a ring shape.
  • a second developing unit 46 is movably sleeved outside the elastic support 30. When bending deformation occurs, the second developing unit 46 can be moved away from the area where the elastic support 30 has a large amount of deformation, so as to prevent the developing member 40 from affecting the compression and rebound deformation of the elastic support 30.
  • the fourth preferred embodiment of the present application provides a stent graft.
  • the developing member 40 includes two developing sections 44 arranged at intervals, two developing sections 44 is symmetrically arranged along the line r connecting the proximal end and the distal end of the elastic support 30 and is located outside the proximal and distal regions of the elastic support 30.
  • the "proximal and distal regions of the elastic support 30" here refer to the points covered by the elastic support 30 whose vertical distance from the proximal and distal ends is less than or equal to 0.5 mm area.
  • the developing section 44 is spirally wound on the outer surface of the elastic support 30.
  • the developing section 44 includes a movable part 441 movably connected with the elastic support 30, and a fixed part 442 fixedly connected with the elastic support 30.
  • the fixed part 442 It is fixed to the elastic support 30 by means of bonding, welding, etc.
  • the fixed portion 442 is located at the two ends of the developing section 44, and the movable portion 441 is located between the two ends of the developing section 44.
  • the movable portion 441 and the elastic support 30 can move relatively, so that the movable portion 441 is moved away from the region where the deformation of the elastic support 30 is large, and the development section 44 is prevented from plastic deformation. Since the two ends of the developing section 44 are fixed, even if the movable portion 441 and the elastic support 30 move relative to each other, the position of the developing section 44 on the elastic support 30 as a whole will not be affected. The position is fixed, and the window 20 can be better positioned for development. In addition, in this embodiment, the entire development section 44 is located outside the proximal and distal regions of the elastic support 30, so that the entire development section 44 can avoid areas where the elastic support 30 has a large amount of deformation, and further avoid the development section 44. Plastic deformation occurs.
  • the developing section 44 may also include one or more, and the developing section 44 may also be located in the proximal and distal regions of the elastic support 30 As long as the fixing portion 442 of the developing section 44 is located outside the proximal and distal regions of the elastic support 30.
  • the fifth preferred embodiment of the present application provides a stent graft.
  • the developing section 44 can also be located at the proximal and distal regions of the elastic support 30 Within the region, as long as the fixing portion 442 of the developing section 44 is located outside the proximal and distal regions of the elastic support 30.
  • the developing member 40 includes four developing sections 44 arranged at intervals.
  • the developing section 44 is spirally wound on the outer surface of the elastic support 30.
  • the developing section 44 includes a fixed part 442 and a movable part movably connected to the elastic support 30. 441.
  • the fixed portion 442 is located at both ends of the developing section 44 and outside the proximal and distal regions of the elastic support 30, and the movable portion 441 is located between the two ends of the developing section 44.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

一种覆膜支架（100），包括中空的管状主体（10），以及设置在管状主体（10）的侧壁上的窗口（20），窗口（20）的周边设置有弹性支撑件（30），弹性支撑件（30）上设置有显影件（40），显影件（40）的至少一部分与弹性支撑件（30）活动连接。由于显影件（40）与弹性支撑件（30）均位于窗口（20）的周边，显影件（40）与弹性支撑件（30）可使窗口（20）的周边同时具有良好的显影性和支撑性。

Description

覆膜支架 技术领域
本发明涉及介入医疗器械技术领域，尤其涉及一种覆膜支架。
背景技术
近十余年来，主动脉覆膜支架腔内隔绝术已广泛应用于胸、腹主动脉的动脉瘤和动脉夹层等病变，其疗效确切、创伤小、恢复快、并发症少，已成为一线的治疗方法。手术时，在X线透视监视下，通过相应的输送系统将覆膜支架送到病变位置，覆膜支架将血流与病变位置隔绝，消除血压对病变位置的影响，以达到治愈的目的。由于人体的血管结构复杂，动脉分支血管较多，对于主动脉弓部、腹腔动脉干、双侧肾动脉或者肠系膜上动脉等特殊病变部位，使用覆膜支架会影响动脉分支血管的血液供应。针对这种情况，需要在覆膜支架上设置预期的孔洞，并建立从覆膜支架的孔洞到动脉分支血管的导丝轨道，这就需要孔洞的边缘具有良好的显影性和支撑性，以确保导丝可顺利通过该孔洞，从而建立导丝轨道。
然而，现有覆膜支架一般在孔洞的边缘设置4个显影点，即上下左右各一个，由于显影点分布较少，建立导丝轨道时不易准确判断孔洞边缘的位置，导致导丝无法顺利通过该孔洞，而造成手术时间延长。
发明内容
本发明要解决的技术问题在于，针对现有技术中的上述缺陷，提供一种覆膜支架。
本发明解决其技术问题所采用的技术方案是：
提供一种覆膜支架，包括中空的管状主体，以及设置在所述管状主体的侧壁上的窗口，所述窗口的周边设置有弹性支撑件，所述弹性支撑件上设置 有显影件，所述显影件的至少一部分与所述弹性支撑件活动连接。
在本发明所述的覆膜支架中，所述显影件呈螺旋状缠绕在所述弹性支撑件的外表面。
在本发明所述的覆膜支架中，所述显影件包括若干个缠绕在所述弹性支撑件上的螺旋单元，所述螺旋单元包括两个相连的连接部，所述连接部与所述弹性支撑件的交点对应的切线与所述连接部的中心线之间的夹角为75°～90°。
在本发明所述的覆膜支架中，所述弹性支撑件为开环结构，在自然状态下，所述弹性支撑件的两个端部至少部分重叠。
在本发明所述的覆膜支架中，所述弹性支撑件的两个端部的重叠部分位于所述弹性支撑件的中部区域。
在本发明所述的覆膜支架中，所述弹性支撑件与所述显影件外包覆有包裹件。
在本发明所述的覆膜支架中，所述弹性支撑件与所述显影件之间设置有隔离件。
在本发明所述的覆膜支架中，所述弹性支撑件上设置有安装槽，所述显影件可活动的连接在所述安装槽内；或者，所述显影件包括多个呈环状的显影单元，所述显影单元可活动的套在所述弹性支撑件外。
在本发明所述的覆膜支架中，所述显影件包括至少一个显影段，所述显影段包括与所述弹性支撑件活动连接的活动部，以及与所述弹性支撑件固定连接的固定部，所述固定部位于所述弹性支撑件的近端区域和远端区域之外。
在本发明所述的覆膜支架中，所述显影件包括两个显影段，所述两个显影段沿所述弹性支撑件的近端与远端的连线对称设置，所述显影段呈螺旋状缠绕在所述弹性支撑件的外表面，所述显影段整体位于所述弹性支撑件的近端区域和远端区域之外。
提供一种覆膜支架，包括中空的管状主体，以及设置在所述管状主体的侧壁上的窗口，所述窗口的周边设置有弹性支撑件，所述弹性支撑件上设置有显影件，所述显影件包括与所述弹性支撑件固定连接的固定部，所述固定 部位于所述弹性支撑件的近端区域和远端区域之外。
在本发明所述的覆膜支架中，所述显影件包括至少一个显影段，所述显影段呈螺旋状缠绕在所述弹性支撑件的外表面，所述显影段包括所述固定部，以及与所述弹性支撑件活动连接的活动部。
在本发明所述的覆膜支架中，所述固定部位于所述显影段的两端。
在本发明所述的覆膜支架中，所述显影段整体位于所述弹性支撑件的近端区域和远端区域之外。
在本发明所述的覆膜支架中，所述显影段包括若干个缠绕在所述弹性支撑件上的螺旋单元，所述螺旋单元包括两个相连的连接部，所述连接部与所述弹性支撑件的交点对应的切线与所述连接部的中心线之间的夹角为75°～90°。
在本发明所述的覆膜支架中，所述弹性支撑件为开环结构，在自然状态下，所述弹性支撑件的两个端部至少部分重叠。
在本发明所述的覆膜支架中，所述弹性支撑件的两个端部的重叠部分位于所述弹性支撑件的中部区域。
在本发明所述的覆膜支架中，所述弹性支撑件与所述显影件外包覆有包裹件。
在本发明所述的覆膜支架中，所述弹性支撑件与所述显影件之间设置有隔离件。
综上所述，实施本发明的一种覆膜支架，具有以下有效果：由于显影件与弹性支撑件均位于窗口的周边，显影件与弹性支撑件可使窗口的周边同时具有良好的显影性和支撑性。并且，由于显影件与弹性支撑件活动连接，当发生弯曲变形时，显影件与弹性支撑件可相对移动，使显影件从弹性支撑件的变形量大的区域移开，避免显影件发生明显弯曲。
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是本发明实施例之一提供的覆膜支架的示意图；
图2是图1所示覆膜支架的窗口周边的显影件与弹性支撑件的示意图；
图3是图2所示弹性支撑件为开环结构的示意图；
图4a与图4b是图2所示显影件的螺旋单元的示意图；
图5a与图5b是图2所示显影件的螺旋单元的对比图；
图6是图2所示弹性支撑件为闭环结构的示意图；
图7a是图2所示弹性支撑件的端部设置有球形部的示意图；
图7b是图2所示弹性支撑件的端部设置有环状结构的示意图；
图8是本发明实施例之二提供的覆膜支架的窗口周边的显影件与弹性支撑件的示意图；
图9是本发明实施例之三提供的覆膜支架的窗口周边的显影件与弹性支撑件的示意图；
图10是本发明实施例之四提供的覆膜支架的窗口周边的显影件与弹性支撑件的示意图。
图11是本发明实施例之五提供的覆膜支架的窗口周边的显影件与弹性支撑件的示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
在介入医疗领域，通常定义覆膜支架在释放后距心脏近的一端为近端，距心脏远的一端为远端。
请参阅图1，本申请实施例之一提供了一种覆膜支架100，包括中空的管状主体10，以及设置在管状主体10的侧壁上的窗口20，管状主体10的管腔构成血流通道。
管状主体10包括裸支架101，以及连接在裸支架101上的覆膜102。裸支架101采用具有良好生物相容性的材料制成，如镍钛、不锈钢等材料。裸支架101包括多圈波形环状物1011，多圈波形环状物1011从近端到远端依次间隔排布，或者连接成网格状结构。覆膜102采用具有良好生物相容性的高分子材料制成，如PTFE、FEP、PET等。
请参阅图1和图2，窗口20的周边设置有弹性支撑件30，弹性支撑件30上设置有显影件40，显影件40与弹性支撑件30活动连接。当覆膜支架100压缩入鞘管时，会径向挤压弹性支撑件30，此时弹性支撑件30会发生明显的弯曲变形，尤其是其近端和远端区域。由于显影件40与弹性支撑件30活动连接，当发生弯曲变形时，显影件40与弹性支撑件30可相对移动，使显影件40从弹性支撑件30的变形量大的区域移开，避免显影件40发生明显弯曲。并且，由于显影件40与弹性支撑件30均位于窗口20的周边，显影件40与弹性支撑件30可使窗口20的周边同时具有良好的显影性和支撑性。
其中，弹性支撑件30选用弹性模量较大的材料制成，如镍钛合金等，以使窗口20的周边具有良好的压缩和回弹特性。显影件40采用具有不透X射线的特性和良好的生物相容性材料制成，如金，钽铌合金，铂铱合金等，以使窗口20的周边具有良好的显影性，但是这类材料的弹性模量较小，导致显影件40的弹性模量小于弹性支撑件30的弹性模量。由于显影件40的弹性模 量相对较小，当发生变形时，显影件40容易出现塑性变形，从而限制与其连接的弹性支撑件30的回弹，导致窗口20无法完全打开，窗口20的开口尺寸减小，进而影响导丝轨道的建立。由于本申请的显影件40与弹性支撑件30活动连接，当发生变形时，显影件40可在弹性支撑件30上移动，并移动至弹性支撑件30的变形量较小的部位，避免显影件40发生塑性变形。
请参阅图3，弹性支撑件30为开环结构，当其处于自然状态下时，弹性支撑件30的两个端部至少部分重叠。此时，弹性支撑件30覆盖在窗口20的全部周边，可完全支撑窗口20的形状。由于弹性支撑件30为开环结构，当发生弹性变形时，弹性支撑件30的两个端部可相对移动，方便弹性支撑件30的径向压缩和回弹变形。
由于弹性支撑件30的近端和远端区域的变形量大，若弹性支撑件30的两个端部的重叠部分位于或靠近弹性支撑件30的近端和远端区域，当发生变形时，弹性支撑件30的端部容易从显影段44的螺旋间隙中伸出，影响二者后续的相对移动。故，为了避免其两个端部之间的相对移动受弯曲变形的影响，弹性支撑件30的两个端部的重叠部分位于弹性支撑件30的中部区域。需要说明的是，此处“弹性支撑件的中部区域”指的是，弹性支撑件30上距其近端和远端的垂直距离大于或等于2mm的点所覆盖的区域。
弹性支撑件30呈椭圆状，其长轴m大致沿平行于覆膜支架100的母线方向，短轴n大致沿垂直于覆膜支架100的母线方向。由于短轴n的尺寸相对较小，当覆膜支架100压缩入鞘管时，弹性支撑件30更容易被径向压缩，在鞘管内产生的回弹力较小，也有利于减少释放时的阻力。本实施例中，弹性支撑件30的长轴m与短轴n的比值满足3/2≤m/n≤3，以利于弹性支撑件30的径向压缩和回弹变形。
请再次参阅图2，显影件40呈螺旋状缠绕在弹性支撑件30的全部外表面上，显影件40围成的螺旋结构的内径大于弹性支撑件30的外经，使显影件40可活动的套设在弹性支撑件30外，当弹性支撑件30发生弹性变形时，弹性支撑件30的两个端部始终位于显影件40围成的螺旋结构内。构成显影件40的显影丝的横截面的内接圆直径大于或等于0.1mm，优选为0.1mm～0.5mm， 以确保显影件40具有良好的显影性。可以理解的是，在其他实施例中，显影件40还可仅缠绕在弹性支撑件30的部分外表面上。
请参阅图4a和图4b，显影件40包括若干个缠绕在弹性支撑件30上的螺旋单元41，螺旋单元41包括两个相连的连接部410，分别为第一连接部410a和第二连接部410b。其中，连接部410与弹性支撑件30的交点对应的切线b与连接部410的中心线a之间的夹角为α，75°≤α≤90°。请参阅图5a和图5b，若连接部410与弹性支撑件30的交点对应的切线b与连接部410的中心线a之间的夹角α较小，当弹性支撑件30弯曲变形时，连接部410容易跟着弹性支撑件30一起弯曲变形，影响显影件40与弹性支撑件30之间的相对移动。并且，由于显影件40的弹性模量相对较小，当发生变形时，显影件40容易出现塑性变形，影响弹性支撑件30的回弹。故，本申请将上述夹角α设置在75°～90°范围内，可以使显影件40与弹性支撑件30之间的相对移动不受弯曲变形的影响，同时避免显影件40发生塑性变形。
可以理解的是，本申请并不限定弹性支撑件30的具体结构，在其他实施例中，弹性支撑件30还可以为闭环结构或圆环状结构等，只要保证弹性支撑件30与显影件40活动连接即可。例如，在图6所示的实施例中，弹性支撑件30为椭圆状的闭环结构。或者，在图7a和图7b所示的实施例中，弹性支撑件30为椭圆状的开环结构，在自然状态下，弹性支撑件30的两个端部至少部分重叠，弹性支撑件30的两个端部设置有球形部31或环状结构32，显影件40呈螺旋状缠绕在弹性支撑件30的外表面。该球形部31与环状结构32的径向尺寸大于相邻两个第一连接部410a(或第二连接部410b)之间的间隙，以避免显影件40与弹性支撑件30相对移动时弹性支撑件30的端部从显影件40的间隙中穿出，确保弹性支撑件30的两个端部始终位于显影件30围成的螺旋结构内。
由于弹性支撑件30与显影件40均由金属材料制成，二者之间存在电位差，如果直接与血液接触，容易产生电化学腐蚀和化学腐蚀，导致弹性支撑件30与显影件40断裂，断裂的弹性支撑件30或显影件40进入体内循环会对患者造成严重伤害。故，装配时，可将连接有显影件40的弹性支撑件30 放入中空的包裹件(未示出)内，然后将包裹件固定在窗口20的周边。
包裹件为环状结构，其采用具有良好生物相容性的高分子材料制成，优选为不透血液的PTFE、ePTFE等。弹性支撑件30可活动的置于包裹件内，包裹件不影响弹性支撑件30与显影件40之间的活动连接。由于包裹件包覆在弹性支撑件30与显影件40外，即使弹性支撑件30或显影件40发生断裂，断裂结构也不会进入人体对患者造成伤害。
实际制作时，在覆膜102上开设窗口20后，将连接有显影件40的弹性支撑件30放置在窗口20的周边，然后将窗口20周边的覆膜102朝向弹性支撑件30的一侧翻折、并将弹性支撑件30包裹在其中，最后将弹性支撑件30内外两侧的覆膜102固定连接。也就是说，本实施例的包裹件由窗口20周边的覆膜102翻折形成。可以理解的是，本实施例并不限定包裹件的具体结构，只要能包覆在弹性支撑件30与显影件40外，且不影响二者的活动连接即可。例如，在其他实施例中，包裹件与覆膜102均为独立部件，包裹件通过缝合的方式固定在窗口20的周边。
进一步的，由于显影件40可活动的缠绕在弹性支撑件30上，当二者发生相对移动时，显影件40与弹性支撑件30之间的摩擦力容易导致弹性支撑件30或显影件40断裂。故，本申请的弹性支撑件30与显影件40之间设置有隔离件(未示出)，隔离件采用具有良好生物相容性的材料制成，如PTFE、FEP、PET等。通过隔离件将弹性支撑件30与显影件40隔离，不仅可避免二者直接接触产生摩擦，还可避免电化学腐蚀和化学腐蚀的发生。
在本实施例中，隔离件通过缝合或热处理等方式包覆在弹性支撑件30的全部外表面上，显影件40可活动的套设在隔离件外。可以理解的是，本实施例中并不限定隔离件在弹性支撑件30上的位置，例如，在其他实施例中，可仅将隔离件包覆在弹性支撑件30的两个端部外，由于弹性支撑件30为开环结构，其两个端部之间的相对摩擦较大，在弹性支撑件30的两个端部外包覆隔离件，可有效避免弹性支撑件30的两个端部断裂。
请参阅图8，本申请较佳实施例之二提供了一种覆膜支架，其与实施例之一的不同之处在于，弹性支撑件30上设置有安装槽35，显影件40可活动的 连接在安装槽35内。
其中，显影件40包括若干个呈球状的第一显影单元45，第一显影单元45可在安装槽35内滚动。当发生弯曲变形时，显影件40与弹性支撑件30可相对移动，使显影件40从弹性支撑件30的变形量大的区域移开，避免显影件40影响弹性支撑件30的挤压和回弹变形。
请参阅图9，本申请较佳实施例之三提供了一种覆膜支架，其与实施例之一的不同之处在于，显影件40包括多个呈环状的第二显影单元46，每一第二显影单元46可活动的套在弹性支撑件30外。当发生弯曲变形时，第二显影单元46可从弹性支撑件30的变形量大的区域移开，避免显影件40影响弹性支撑件30的挤压和回弹变形。
请参阅图10，本申请较佳实施例之四提供了一种覆膜支架，其与实施例之一的不同之处在于，显影件40包括两个间隔设置的显影段44，两个显影段44沿弹性支撑件30的近端与远端的连线r对称设置，且位于弹性支撑件30的近端区域和远端区域之外。需要说明的是，此处“弹性支撑件30的近端区域和远端区域”指的是，弹性支撑件30上距其近端和远端的垂直距离小于或等于0.5mm的点所覆盖的区域。
其中，显影段44呈螺旋状缠绕在弹性支撑件30的外表面，显影段44包括与弹性支撑件30活动连接的活动部441，以及与弹性支撑件30固定连接的固定部442，固定部442通过粘接、焊接等方式固定在弹性支撑件30上。固定部442位于显影段44的两端，活动部441位于显影段44的两端之间。
当发生变形时，活动部441与弹性支撑件30可相对移动，使活动部441从弹性支撑件30的变形量大的区域移开，避免显影段44发生塑性变形。由于显影段44的两端固定，即使活动部441与弹性支撑件30发生相对移动，也不影响显影段44整体在弹性支撑件30上的位置，即显影段44整体在弹性支撑件30上的位置固定，可较好的对窗口20进行显影定位。并且，本实施例使显影段44整体位于弹性支撑件30的近端区域和远端区域之外，可使显影段44整体避开弹性支撑件30的变形量大的区域，进一步避免显影段44发生塑性变形。
可以理解的是，本实施例并不限定显影段44的具体数量和位置，显影段44还可包括一个或多个，显影段44也可位于弹性支撑件30的近端区域和远端区域内，只要显影段44的固定部442位于弹性支撑件30的近端区域和远端区域之外即可。
请参阅图11，本申请较佳实施例之五提供了一种覆膜支架，其与实施例之四的不同之处在于，显影段44也可位于弹性支撑件30的近端区域和远端区域内，只要显影段44的固定部442位于弹性支撑件30的近端区域和远端区域之外即可。例如，显影件40包括四个间隔设置的显影段44，显影段44呈螺旋状缠绕在弹性支撑件30的外表面，显影段44包括固定部442，以及与弹性支撑件30活动连接的活动部441，固定部442位于显影段44的两端，且位于弹性支撑件30的近端区域和远端区域之外，活动部441位于显影段44的两端之间。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上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，包括中空的管状主体，以及设置在所述管状主体的侧壁上的窗口，所述窗口的周边设置有弹性支撑件，其特征在于，所述弹性支撑件上设置有显影件，所述显影件的至少一部分与所述弹性支撑件活动连接。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述显影件呈螺旋状缠绕在所述弹性支撑件的外表面。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述显影件包括若干个缠绕在所述弹性支撑件上的螺旋单元，所述螺旋单元包括两个相连的连接部，所述连接部与所述弹性支撑件的交点对应的切线与所述连接部的中心线之间的夹角为75°～90°。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述弹性支撑件为开环结构，在自然状态下，所述弹性支撑件的两个端部至少部分重叠。
  5. 根据权利要求3所述的覆膜支架，其特征在于，所述弹性支撑件的两个端部的重叠部分位于所述弹性支撑件的中部区域。
  6. 根据权利要求1所述的覆膜支架，其特征在于，所述弹性支撑件与所述显影件外包覆有包裹件。
  7. 根据权利要求1所述的覆膜支架，其特征在于，所述弹性支撑件与所述显影件之间设置有隔离件。
  8. 根据权利要求1所述的覆膜支架，其特征在于，所述弹性支撑件上设置有安装槽，所述显影件可活动的连接在所述安装槽内；或者，所述显影件包括多个呈环状的显影单元，所述显影单元可活动的套在所述弹性支撑件外。
  9. 根据权利要求1所述的覆膜支架，其特征在于，所述显影件包括至少一个显影段，所述显影段包括与所述弹性支撑件活动连接的活动部，以及与所述弹性支撑件固定连接的固定部，所述固定部位于所述弹性支撑件的近端区域和远端区域之外。
  10. 根据权利要求9所述的覆膜支架，其特征在于，所述显影件包括两个显影段，所述两个显影段沿所述弹性支撑件的近端与远端的连线对称设置， 所述显影段呈螺旋状缠绕在所述弹性支撑件的外表面，所述显影段整体位于所述弹性支撑件的近端区域和远端区域之外。
  11. 一种覆膜支架，包括中空的管状主体，以及设置在所述管状主体的侧壁上的窗口，所述窗口的周边设置有弹性支撑件，其特征在于，所述弹性支撑件上设置有显影件，所述显影件包括与所述弹性支撑件固定连接的固定部，所述固定部位于所述弹性支撑件的近端区域和远端区域之外。
  12. 根据权利要求11所述的覆膜支架，其特征在于，所述显影件包括至少一个显影段，所述显影段呈螺旋状缠绕在所述弹性支撑件的外表面，所述显影段包括所述固定部，以及与所述弹性支撑件活动连接的活动部。
  13. 根据权利要求12所述的覆膜支架，其特征在于，所述固定部位于所述显影段的两端。
  14. 根据权利要求12所述的覆膜支架，其特征在于，所述显影段整体位于所述弹性支撑件的近端区域和远端区域之外。
  15. 根据权利要求12所述的覆膜支架，其特征在于，所述显影段包括若干个缠绕在所述弹性支撑件上的螺旋单元，所述螺旋单元包括两个相连的连接部，所述连接部与所述弹性支撑件的交点对应的切线与所述连接部的中心线之间的夹角为75°～90°。
  16. 根据权利要求11所述的覆膜支架，其特征在于，所述弹性支撑件为开环结构，在自然状态下，所述弹性支撑件的两个端部至少部分重叠。
  17. 根据权利要求15所述的覆膜支架，其特征在于，所述弹性支撑件的两个端部的重叠部分位于所述弹性支撑件的中部区域。
  18. 根据权利要求11所述的覆膜支架，其特征在于，所述弹性支撑件与所述显影件外包覆有包裹件。
  19. 根据权利要求1所述的覆膜支架，其特征在于，所述弹性支撑件与所述显影件之间设置有隔离件。
PCT/CN2020/099011 2019-06-27 2020-06-29 覆膜支架 WO2020259709A1 (zh)

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