WO2009140861A1 - 带开口的覆膜支架及覆膜支架的束缚方法 - Google Patents

带开口的覆膜支架及覆膜支架的束缚方法 Download PDF

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Publication number
WO2009140861A1
WO2009140861A1 PCT/CN2009/000552 CN2009000552W WO2009140861A1 WO 2009140861 A1 WO2009140861 A1 WO 2009140861A1 CN 2009000552 W CN2009000552 W CN 2009000552W WO 2009140861 A1 WO2009140861 A1 WO 2009140861A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
stent
binding
opening
segment
Prior art date
Application number
PCT/CN2009/000552
Other languages
English (en)
French (fr)
Inventor
朱清
罗七一
袁振宇
高延彬
Original Assignee
微创医疗器械(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 微创医疗器械(上海)有限公司 filed Critical 微创医疗器械(上海)有限公司
Priority to EP09749404.1A priority Critical patent/EP2298248B1/en
Publication of WO2009140861A1 publication Critical patent/WO2009140861A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the present invention relates to a method of binding a stent graft and a stent graft, and more particularly to a method of binding a stent graft and a stent graft with an opening that can be freely rotated prior to release of the stent.
  • Abdominal aortic aneurysm refers to the limitation or diffuse bulging of the abdominal aorta caused by lesions or injury of the arterial wall.
  • the main symptoms are pulsatile mass, which is more common in AAA below the renal artery plane, which may involve one or both sides.
  • Brachial artery. Pathology is divided into true aneurysms, aneurysms and dissection aneurysms. Once an aneurysm rupture occurs, the wall thrombus in the aneurysm is detached and the arterial embolization is required, which requires urgent treatment.
  • Abdominal aortic aneurysm is one of the common diseases that endanger the life of middle-aged and elderly people. With the aging of the population and the prevalence of diabetes, atherosclerosis, hypertension and other diseases, the prevalence of abdominal aortic aneurysm is increasing year by year. increase.
  • stent graft endovascular grafting for the treatment of abdominal aortic aneurysm can achieve good results. Compared with conventional open surgery, it has the advantages of less trauma, faster postoperative recovery, less complications, and significantly shortened hospital stay. Especially for high-risk patients with severe comorbidities who cannot tolerate traditional surgery, there is an opportunity for treatment. However, there are certain contraindications to the treatment of the abdominal aorta using traditional stents, such as: the neck is short, the length is less than 15 mm, and the angle is greater than 60. The proximal neck, torsional condylar aneurysm, involving the visceral artery.
  • the open bracket shows its outstanding advantages.
  • the existing stent with side holes opens one or more openings at the proximal end portion, after releasing the stent graft
  • the opening is aligned with the opening of important branch vessels such as the renal artery, the mesenteric and the celiac trunk artery, so that the region between the renal artery and the celiac trunk artery or other important branch vessels can be used as the neck to position the stent, thereby solving the above problem.
  • the object of the present invention is to solve the above problems, and to provide a stent graft with an opening, which can freely rotate and align the stent before release, thereby facilitating accurate positioning of the stent opening and the renal artery opening, and improving The success rate of surgery.
  • Another object of the present invention is to provide a method for binding a stent graft, which can be used in such a restraining manner to allow the stent to be freely rotated and aligned before being released, which facilitates accurate positioning of the stent opening and the renal artery opening, and improves the positioning. Surgical success rate.
  • the technical solution of the present invention is:
  • the present invention discloses a stent graft with an opening, comprising a plurality of annular wave-shaped stent segments and a film which is sutured into a tubular shape with the stent segments, wherein at least the film-coated tube is opened An opening in which an opening fixing wire is sewn to support the openings.
  • the above-mentioned covered stent graft has a U-shaped opening at the end of the laminating tube, and is directly supported by the corrugated bracket segment as an opening fixing wire.
  • coated stent with an opening, wherein a circumferential or elliptical opening is formed in a side surface of the laminating tube.
  • the above-mentioned coated stent with an opening wherein the opening fixing wire can be sewn into a circular, elliptical, bracket-shaped, rhombic or flying saucer-shaped shape.
  • the invention further discloses a method for binding a stent graft, wherein the method comprises: suturing a coil on a stent segment of the stent graft;
  • the control guide wire is passed through both ends of the double stranded wire.
  • the double-stranded binding wire is fixedly connected to the control guide wire by a binding wire end end and a tail end around the stent graft, and the control guide wire is Pass through the circles at the head and tail ends to constrain the diameter of the stent to a circle having a circumference of the length of the binding line.
  • the above method for binding a stent graft wherein the manner of suturing the coil on the stent segment of the stent graft further comprises:
  • the coil can be stitched to the ribs of the stent segment.
  • the above method for binding a stent graft wherein the manner of suturing the coil on the stent segment of the stent graft further comprises:
  • the coil is stitched in the middle of the rib of the stent segment.
  • one stitch is stitched to the apex of the most distal stent segment or two to three coils are stitched at the apex of the adjacent rib.
  • the manner of suturing the coil on the stent segment of the stent graft further comprises: the coil can be sutured on each of the ribs or the ribs.
  • the length of each of the double stranded strands may be the same or different.
  • the double-stranded restraint line may be a closed line or a single-stranded or double-stranded knot.
  • a coil is also sewn on the ejector tube in the delivery system for transporting and ejecting the stent graft.
  • the stent graft In the initial state, the stent graft is pressed into the outer tube to be constrained to a minimum diameter.
  • the outer tube When released, the outer tube is first drawn downward, the stent graft is released from the outer tube, and the diameter is increased to the size of the restraint line; the last segment of the frame and the top
  • the tube end is connected by a binding wire and a control guide wire, so that the stent graft can rotate with the rotation of the top tube; After the hole is positioned, the control guide wire is removed, the binding line is released, and the stent naturally expands to the blood vessel size due to its elasticity.
  • the present invention supports the opening by suturing the fixing wire around the opening, and overcomes the defects in the prior art that only the suture is used to lock the opening and the opening is easily deformed.
  • the double-stranded restraint wire is restrained in the circumferential direction by the coil in the circumferential direction in the middle of the stent segment of the stent graft, and the control wire is used to fix both ends of the restraint wire.
  • This new tethering method allows the stent to be freely rotated prior to release compared to the prior art, which is highly advantageous for accurate positioning of the stent opening and the arterial opening.
  • FIG. 1 is a schematic view showing the structure of a stent graft with an opening according to the present invention.
  • Figure 2 is an enlarged view of a side hole portion.
  • Fig. 3A is a schematic view showing the shape of the opening fixing ring.
  • Fig. 3B is a schematic view showing the shape of the U-shaped mouth bracket section.
  • Fig. 4 is a schematic view showing the manner of binding of the stent graft of the present invention.
  • 5A to 5C are schematic views showing the structure of the binding line.
  • Figure 6 is a schematic view showing the connection of the top tube and the distal end of the stent.
  • FIG. 7A to 7C are schematic views showing the release manner of the stent graft of the present invention. detailed description
  • Figure 1 shows the structure of an open-coated stent graft of the present invention.
  • the film-covered stent 1 includes a corrugated NiTi wire stent segment 10 and a polymer material-coated tube 20, and the NiTi wire stent segment 10 is sewn to the film-coated tube 20.
  • the solid NiTi wire in Figure 1 indicates that it is sewn to the outside of the film tube 20, and the dotted NiTi wire indicates that it is sewn into the film tube 20.
  • One or more openings are opened in the laminar tube 20 depending on the specific location of the patient's renal artery as a pathway for the renal artery or other major blood vessels. These openings include a side opening 31 and a U-shaped opening 32.
  • FIG. 2 is an enlarged view of the side opening 31.
  • An opening fixing wire 40 made of NiTi wire is sewn at the side opening 31.
  • the opening fixing wire 40 can play a supporting role for the opening, preventing the circumferential or elliptical side opening 31 from being deformed or even folded under the action of an external force, obstructing the passage of blood flow. Road.
  • the remainder of Figure 2 is the waved stent segment 10.
  • the opening fixing wire 40 can also be made of other metal materials.
  • U-shaped openings 32 are opened. These U-shaped openings 32 are directly supported by the special-shaped corrugated support segments 10 as the opening fixing wires.
  • the special shape of the corrugated support segments 10 is shown in FIG. 3A to B. As shown, the solid line in Fig. 3B indicates the U-shaped opening cut at the edge of the film tube 20, and the broken line indicates the NiTi wire.
  • the shape of the opening fixing wire 40 as shown in Fig. 3A, can be stitched into a circular shape, an elliptical shape, a bracket shape, a diamond shape, a flying saucer shape, and the like.
  • the circles in Fig. 3A each indicate an opening in the coating tube 20, and the patterns on the outside of the opening are all in the shape of different opening fixing wires.
  • Figure 4 shows the manner in which the stent graft is restrained.
  • the coil is first sutured on the stent segment of the stent graft, and then the double stranded wire 50 is passed through the coil in the circumferential direction to be bound to the stent graft, and finally the control guide wire is passed through the double stranded strand. Both ends.
  • the double-stranded binding line is knotted into a double strand by a polymer strand, and the length of the binding strand is smaller than the circumferential circumference of the tubular tube in an expanded state.
  • the double stranded binding line is wrapped around the circumferential direction of the stent graft.
  • the head end 500 of the binding wire 50 is fixedly connected with the tail end 501 on the control guide wire 60, so that the control guide wire 60 is fixed from the head end.
  • the circle 500 of the 500 and the trailing end 501 is passed through to constrain the diameter of the stent to a circle having a circumference of the binding line length L.
  • the length of each double stranded strand may be the same or different.
  • the double stranded line can be a closed line or a single or double strand that is knotted end to end.
  • the manner of suturing the coil on the stent segment of the stent graft comprises: stitching the coil on the edge of the stent segment, and further stitching the coil in the middle of the edge of the stent segment; stitching the coil to each edge of the stent segment Or stitched by ribs.
  • a coil is stitched at the apex of the most distal stent segment or 2 to 3 coils are stitched at the apex of the adjacent prism.
  • the manner in which the double-stranded binding line is constrained by the coil in the middle of the stent segment of the stent graft further comprises: first, by using a suture, a circle 502 having a diameter of 1 to 3 mm in the middle of each edge of the stent segment, and then binding the binding line 50 Passing through the circle 502 to achieve the purpose of securing the tether line 50 in the middle of the stent segment.
  • control wire 60 is used to secure both ends of the binding wire 50. After all the bracket segments are restrained in the manner described above, they are compressed to the minimum diameter for loading into the outer tube. At this point, the binding process ends.
  • the branches of different positions on the stent graft can be made according to the intraluminal diameter of the blood vessel.
  • the frame segment uses different constraint ratios.
  • the diameter of the stent can be constrained to 30% - 100% of the original size, ensuring that the stent can be freely rotated, moved and adjusted in the lumen of the vessel in a partially pre-released state, while ensuring the guide wire and The catheter is easily passed through the stent in a restrained state.
  • the proximal segment In the process of restraint, for the large bracket (diameter larger than 20cm), the proximal segment is restrained by the polymer sleeve, and when the part is released, the constraint segment is loosened, so that the bracket can be rotated in the circumferential direction, otherwise the segment is opened. Unable to move.
  • small-diameter stents (less than 20 cm in diameter)
  • the apex of the first segment of the lamella refers to the apex of the first stent segment of the proximal end of the stent graft
  • Coils are also sewn on the ejector tube in the delivery system for transporting and ejecting the stent graft.
  • the binding coil 502a on the top tube 70 is inserted into the binding coil of the stent graft 1. 502b, then the control guide wire 60 is passed through the binding coil 502a, so that the stent graft 1 is connected with the top tube 70, and the top tube 70 can be rotated 360 degrees in the circumferential direction when the bracket 1 is partially pre-released.
  • the bracket 1 adjusts the positioning.
  • Fig. 7 shows the corresponding release method of the above-described binding method.
  • the stent 1 is completely crimped within the outer tube 80 in the initial state, constrained to the smallest diameter, i.e., the outer diameter of the outer tube (shown in Figure 7A).
  • the outer tube 80 is withdrawn downwardly, the stent is released from the outer tube 80, and the diameter is increased to the size of the restraint line control (shown in Figure 7B).
  • the embodiment adopts a new restraining manner to constrain the bracket segment in the circumferential direction, so that the diameter of the bracket is uniformly reduced, and the problem that the relative positions of the two windows are moved when other methods are restrained is avoided. This makes it easier to position the holes for more than two openings.
  • the control guide wire is removed, and the stent diameter is restored to the size of the implanted blood vessel (shown in Fig. 7C). The diameter is smaller than the natural state.
  • the end of the last section of the pre-top tube 70 of the stent is connected by a binding wire and a control guide wire so that the stent can rotate with the rotation of the top tube.

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

Description

带开口的覆膜支架及覆膜支架的束缚方法
技术领域
本发明涉及一种覆膜支架及覆膜支架的束缚方法， 尤其涉及一种在支 架释放之前可以自由旋转对准的带开口的覆膜支架及覆膜支架的束缚方 法。 背景技术
腹主动脉瘤 （ AAA)是指动脉壁病变或损伤导致腹主动脉局限或弥漫 性膨出， 以搏动性肿块为主要症状， 以肾动脉平面以下的 AAA多见， 可 累及一侧或双侧髂动脉。 病理学分为真性动脉瘤 艮性动脉瘤和夹层动脉 瘤。一旦发生动脉瘤破裂,动脉瘤内附壁血栓形成脱落致动脉栓塞， 即需紧 急处理。 腹主动脉瘤是一种危及中老年人生命的常见疾病之一， 随着人口 老龄化及糖尿病、 动脉粥样硬化、 高血压等疾病患病率的增加， 腹主动脉 瘤的患病率逐年增加。
对于传统开放式外科手术来说， 影响手术的危险因素主要是高龄、 严 重的心肺疾病和肾功能不全。 腹主动脉瘤患者多为老年人， 常常合并冠心 病、 高血压、 糖尿病、 脑血栓、 慢性阻塞性肺病和肾功能不全等严重疾病。 术前积极纠治合并症， 待患者的心肺功能好转， 血压、 血糖稳定的情况下 再进行手术治疗才是安全的。
釆用覆膜支架腔内隔绝术治疗腹主动脉瘤可取得良好效果， 比起常规 开放式外科手术， 其优点是创伤小、 术后恢复快、 并发症少、 明显缩短了 住院时间。 尤其是为一些有严重合并症， 不能耐受传统手术的高危患者提 供了治疗的机遇。 但使用传统支架治疗腹主动脉有一定的禁忌症， 如： 瘤 颈短、 长度小于 15毫米、 成角大于 60。的近端瘤颈， 扭转锥形动脉瘤， 累 及内脏动脉等。 因为瘤颈短会造成支架近端没有足够的锚定区而导致支架 移位， 累及内脏动脉的瘤体不能使用覆膜支架隔绝。 根据以上的禁忌症， 约有 30 % ~ 40 %的患者不能使用常规的覆膜支架进行治疗。 在这种情况 下， 开口支架就显示出它的突出优势。
现有的带侧孔的支架在近端部位开 1个或多个开口， 释放覆膜支架后 开口对准肾动脉、 肠系膜上和腹腔干动脉等重要分支血管的开口， 这样就 可以利用肾动脉至腹腔干动脉之间或其他重要分支血管之间的区域作为 瘤颈来定位支架， 从而解决了以上问题。
但是这样的覆膜支架也存在以下的问题： 覆膜支架在释放之前无法自 由旋转对准， 使得支架开口与肾动脉开孔的准确定位存在一定的困难， 影 响了手术的成功率。 发明内容
本发明的发明目的在于解决上述问题， 提供了一种带开口的覆膜支 架， 这种覆膜支架可以使支架在释放之前自由旋转对准， 有利于支架开口 与肾动脉开口的准确定位， 提高了手术成功率。
本发明的另一目的在于提供了一种覆膜支架的束缚方法， 釆用这样的 束缚方式， 可以使支架在释放之前自由旋转对准， 有利于支架开口与肾动 脉开口的准确定位， 提高了手术成功率。
本发明的技术方案为： 本发明揭示了一种带开口的覆膜支架， 包括若 干环状波形支架段以及与该些支架段缝合成管状的覆膜， 其中， 在覆膜管 上开有至少一个开口， 在该些开口处缝合有开口固定丝以对该些开口起支 撑作用。
上述的带开口的覆膜支架， 其中， 在所述覆膜管头端开有 U形开口， 直接由波形支架段做开口固定丝支撑。
上述的带开口的覆膜支架， 其中， 在所述覆膜管侧面开有圓周形或者 椭圓形开口。
上述的带开口的覆膜支架， 其中， 所述开口固定丝是由 NiTi 合金丝 制成。
上述的带开口的覆膜支架， 其中， 所述开口固定丝可缝合成圓形、 椭 圓形、 括号形、 菱形或飞碟形的形状。
本发明另外揭示了一种覆膜支架的束缚方法， 其中， 该方法包括： 在覆膜支架的支架段上缝合线圈；
沿圓周方向将双股束缚线穿过线圈使之束缚在覆膜支架上；
将控制导丝穿过双股束缚线的两端。 上述的覆膜支架的束缚方法， 其中， 所述双股束缚线是绕所述覆膜支 架一周后将束缚线头端与尾端套在所述控制导丝上固定相连， 使所述控制 导丝从头端和尾端的圓圈中穿过， 以使支架直径约束至以束缚线长度为周 长的圓内。
上述的覆膜支架的束缚方法， 其中， 在所述覆膜支架的支架段上缝合 线圈的方式进一步包括：
所述线圈可以缝合在支架段的棱上。
上述的覆膜支架的束缚方法， 其中， 在所述覆膜支架的支架段上缝合 线圈的方式进一步包括：
所述线圈缝合在支架段的棱的中间位置。
上述的覆膜支架的束缚方法， 其中， 对于小直径支架， 釆用双股束缚 线约束覆膜首段棱顶点的方式。
上述的覆膜支架的束缚方法， 其中， 在最远端支架段的棱顶点上缝合 有 1个线圈或者在相邻棱顶点上缝合有 2 ~ 3个线圈。
上述的覆膜支架的束缚方法， 其中， 在所述覆膜支架的支架段上缝合 线圈的方式进一步包括： 所述线圈可以缝合在支架段上的每一个棱上或隔 棱缝合。
上述的覆膜支架的束缚方法， 其中， 所述的各条双股束缚线长度可以 相同， 也可以不同。
上述的覆膜支架的束缚方法， 其中， 所述的双股束缚线可以为一条闭 合的线， 也可以为首尾打结的单股线或者双股线。
上述的覆膜支架的束缚方法， 其中， 在用于输送、 顶出覆膜支架的输 送系统内的顶出管上， 也缝合有线圈。
上述的覆膜支架的束缚方法， 其中， 该束缚方法还包括一覆膜支架的 释放过程：
初始状态下覆膜支架被压握在外管内以约束成最小直径， 释放时先向 下抽出外管， 覆膜支架从外管中释放， 直径增加到束缚线控制的大小； 架的最后一段与顶管头端用束缚线和控制导丝相连接， 使得覆膜支架可随 顶管的旋转而旋转； 对孔定位后抽掉控制导丝， 束缚线松开， 支架由于自身弹性自然扩张 到血管尺寸。
本发明对比现有技术有如下的有益效果： 本发明通过在开口周围缝合 固定丝的方式对开口进行支撑， 克服了现有技术中仅釆用缝合线对开口锁 边、 开口易变形的缺陷。 本发明通过束缚时沿圓周方向将双股束缚线用线 圈约束在覆膜支架的支架段的中间位置， 再用控制导丝固定束缚线的两 端。 这种全新的束缚方式较之现有技术可使得支架在释放之前就能自由旋 转对准， 非常有利于支架开口和动脉开口的准确定位。 附图说明
图 1是本发明的带开口的覆膜支架的结构示意图。
图 2是侧孔部份的放大图。
图 3A是开口固定环的形状示意图。
图 3B是 U形口支架段的形状示意图。
图 4是本发明的覆膜支架的束缚方式示意图。
图 5A ~ 5C是束缚线的结构示意图。
图 6是顶管与支架远端的连接方式示意图。
图 7A ~ 7C是本发明的覆膜支架的释放方式示意图。 具体实施方式
下面结合附图和实施例对本发明作进一步的描述。
图 1示出了本发明的带开口的覆膜支架的结构。 请参见图 1 , 覆膜支 架 1包括波形的 NiTi丝支架段 10和高分子材料覆膜管 20 , NiTi丝支架段 10被缝合在覆膜管 20上。 图 1 中实线的 NiTi丝表示其缝合在覆膜管 20 外， 虚线的 NiTi丝表示其缝合在覆膜管 20内。 根据病人肾动脉的具体位 置在覆膜管 20上开设 1个或多个开口， 作为肾动脉或其他主要血管的通 路。 这些开口包括侧面开口 31和 U形开口 32。
图 2是侧面开口 31的放大图。 在侧面开口 31处缝合了 NiTi丝制成 的开口固定丝 40。 开口固定丝 40可以起到对开口的支撑作用， 防止圓周 形或者椭圓形的侧面开口 31 在外力作用下变形甚至折叠， 阻碍血流的通 路。 图 2中的其余部份为波形支架段 10。 开口固定丝 40也可以由其他金 属材料制成。
在覆膜管 20的头端开有 U形开口 32 , 这些 U形开口 32直接釆用特 殊形状的波形支架段 10作为开口固定丝支撑， 这种波形支架段 10的特殊 形状参见图 3A ~ B所示， 图 3B中的实线表示在覆膜管 20边缘裁出的 U 形开口， 虚线表示 NiTi丝。 开口固定丝 40的形状请参见图 3A, 可以缝合 成圓形、 椭圓形、 括号形、 菱形、 飞碟形等。 在图 3A中的圓圈均表示覆 膜管 20上的开口， 开口外边的图形均为不同的开口固定丝的形状。
图 4示出了覆膜支架的束缚方式。 请参见图 4 , 首先在覆膜支架的支 架段上缝合线圈， 接着沿圓周方向将双股束缚线 50 穿过线圈使之束缚在 覆膜支架上，最后将控制导丝穿过双股束缚线的两端。请同时参见图 5A ~ 5C , 其中的双股束缚线是由高分子线打结成双股， 束缚线的长度小于覆膜 管扩张状态下的圓周周长。 然后将双股束缚线围在覆膜支架圓周方向上， 绕覆膜支架一周后将束缚线 50的头端 500与尾端 501套在控制导丝 60上 固定相连， 使控制导丝 60从头端 500和尾端 501的圓圈 502中穿过， 以 使支架直径约束至以束缚线长度 L为周长的圓内。各条双股束缚线的长度 可以相同， 也可以不同。 双股束缚线可以是一条闭合的线， 也可以为首尾 打结的单股线或者双股线。
覆膜支架的支架段上缝合线圈的方式包括： 将线圈缝合在支架段的棱 上， 更进一步的是将线圈缝合在支架段的棱的中间位置； 将线圈缝合在支 架段的每一个棱上或隔棱缝合。 在最远端支架段的棱顶点上缝合有 1个线 圈或者在相邻棱顶点上缝合有 2 ~ 3个线圈。
双股束缚线用线圈约束在覆膜支架的支架段的中间位置的方式进一 步包括： 先在支架段每一棱的中间用缝合线打一个直径为 1 ~ 3mm的圓圈 502 , 然后将束缚线 50从圓圈 502中穿过， 以达到将束缚线 50 固定在支 架段中间的目的。
继续图 4 , 再用控制导丝 60固定束缚线 50的两端。 待所有的支架段 都釆用上述的方式束缚后， 再压缩至最小直径以便装入外管内。 至此， 束 缚过程结束。
在束缚过程中， 可以根据血管的腔内直径对覆膜支架上不同位置的支 架段釆用不同的约束比例。 通过调整束缚线的长度 L , 可将支架直径约束 至原来尺寸的 30 % - 100 % , 保证支架在部份预释放的状态下在血管腔内 可以自由旋转、 移动调整位置， 同时保证导丝和导管易于从约束状态的支 架中通过。
在束缚过程中， 对于大支架 （直径大于 20cm ) 近端棵段釆用高分子 套管约束， 部份释放时约束棵段松开， 以使支架可以圓周方向转动， 否则 棵段张开后就无法移动了。 对于小直径支架（直径小于 20cm ), 在覆膜支 架最近端通常都有一个棵的支架段 （没有覆膜）， 釆用双股束缚线约束覆 膜首段 201 (请参见图 4所示） 棱顶点的方式 （覆膜首段棱顶点是指覆膜 支架最近端覆膜的首个支架段的棱顶点）， 解决了小直径支架无法使用套 管而不能约束的问题（棵段太短， 易从套管中弹出）。
在用于输送、顶出覆膜支架的输送系统内的顶出管上，也缝合有线圈。 在束缚过程中， 对于覆膜支架 1 的远端与顶出管 70头部相连接的情况， 请参见图 6所示， 顶管 70上的束缚线圈 502a套入覆膜支架 1上的束缚线 圈 502b , 然后将控制导丝 60从束缚线圈 502a中穿过， 这样就将覆膜支架 1与顶管 70连接起来，可在支架 1部份预释放时在圓周方向 360度转动顶 管 70以带动支架 1调整定位。
图 7示出了上述这种束缚方法相应的释放方法。 请参见图 7A ~ 7C , 支架 1在初始状态下完全被压握在外管 80 内， 被约束成最小直径即外管 内径 （图 7A所示）。 释放时向下抽出外管 80 , 支架从外管 80中释放， 直 径增加到束缚线控制的大小（图 7B所示）。 由于束缚线约束支架处于部份 预释放状态， 本实施例釆用全新的束缚方式沿圓周方向约束支架段， 使得 支架直径均匀减少，避免了其他方法约束时 2个开窗相对位置移动的问题， 从而更易于 2个以上开口的对孔定位。 定位完毕后抽掉控制导丝， 支架直 径就恢复到所植入血管的尺寸 (图 7C所示）。 直径小于自然状态。 支架的最后一段预顶管 70 头端用束缚线和控制导丝 相连接， 使得支架可以随顶管的旋转而旋转。 对孔定位后抽掉控制导丝， 束缚线松开， 支架由于自身的弹性自然扩张到血管尺寸。 撤出输送器后支 架就留在患者体内。 上述实施例是提供给本领域普通技术人员来实现或使用本发明的， 本 领域普通技术人员可在不脱离本发明的发明思想的情况下， 对上述实施例 做出种种修改或变化， 因而本发明的保护范围并不被上述实施例所限， 而 应该是符合权利要求书提到的创新性特征的最大范围。

Claims

权 利 要 求 书
1、 一种带开口的覆膜支架， 包括若干环状波形支架段以及与该些支架段 缝合成管状的覆膜， 其特征在于， 在覆膜管上开有至少一个开口， 在该些 开口处缝合有开口固定丝以对该些开口起支撑作用。
2、 根据权利要求 1 所述的带开口的覆膜支架， 其特征在于， 在所述覆膜 管头端开有 U形开口， 直接由波形支架段做开口固定丝支撑。
3、 根据权利要求 1 所述的带开口的覆膜支架， 其特征在于， 在所述覆膜 管侧面开有圓周形或者椭圓形开口。
4、 根据权利要求 1 所述的带开口的覆膜支架， 其特征在于， 所述开口固 定丝是由 NiTi合金丝制成。
5、 根据权利要求 1 所述的带开口的覆膜支架， 其特征在于， 所述开口固 定丝可缝合成圓形、 椭圓形、 括号形、 菱形或飞碟形的形状。
6、 一种覆膜支架的束缚方法， 其特征在于， 该方法包括：
在覆膜支架的支架段上缝合线圈；
沿圓周方向将双股束缚线穿过线圈使之束缚在覆膜支架上；
将控制导丝穿过双股束缚线的两端。
7、 根据权利要求 6 所述的覆膜支架的束缚方法， 其特征在于， 所述双股 束缚线是绕所述覆膜支架一周后将束缚线头端与尾端套在所述控制导丝 上固定相连， 使所述控制导丝从头端和尾端的圓圈中穿过， 以使支架直径 约束至以束缚线长度为周长的圓内。
8、 根据权利要求 6 所述的覆膜支架的束缚方法， 其特征在于， 在所述覆 膜支架的支架段上缝合线圈的方式进一步包括： 所述线圈可以缝合在支架段的棱上。
9、 根据权利要求 8 所述的覆膜支架的束缚方法， 其特征在于， 在所述覆 膜支架的支架段上缝合线圈的方式进一步包括：
所述线圈缝合在支架段的棱的中间位置。
10、 根据权利要求 8所述的覆膜支架的束缚方法， 其特征在于， 对于小直 径支架， 釆用双股束缚线约束覆膜首段棱顶点的方式。
11、 根据权利要求 8所述的覆膜支架的束缚方法， 其特征在于， 在最远端 支架段的棱顶点上缝合有 1个线圈或者在相邻棱顶点上缝合有 2 ~ 3个线 圈。
12、 根据权利要求 8所述的覆膜支架的束缚方法， 其特征在于， 在所述覆 膜支架的支架段上缝合线圈的方式进一步包括： 所述线圈可以缝合在支架 段上的每一个棱上或隔棱缝合。
13、 根据权利要求 6 ~ 12中任一项所述的覆膜支架的束缚方法， 其特征在 于， 所述的各条双股束缚线长度可以相同， 也可以不同。
14、 根据权利要求 6 ~ 12中任一项所述的覆膜支架的束缚方法， 其特征在 于， 所述的双股束缚线可以为一条闭合的线， 也可以为首尾打结的单股线 或者双股线。
15、 根据权利要求 11 所述的覆膜支架的束缚方法， 其特征在于， 在用于 输送、 顶出覆膜支架的输送系统内的顶出管上， 也缝合有线圈。
16、 根据权利要求 6 ~ 15中任一项所述的覆膜支架的束缚方法， 其特征在 于， 该束缚方法还包括一覆膜支架的释放过程：
初始状态下覆膜支架被压握在外管内以约束成最小直径， 释放时先向下抽 出外管， 覆膜支架从外管中释放， 直径增加到束缚线控制的大小； 最后一段与顶管头端用束缚线和控制导丝相连接， 使得覆膜支架可随顶管 的旋转而旋转；
对孔定位后抽掉控制导丝， 束缚线松开， 支架由于自身弹性自然扩张到血 管尺寸。
PCT/CN2009/000552 2008-05-21 2009-05-20 带开口的覆膜支架及覆膜支架的束缚方法 WO2009140861A1 (zh)

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