WO2013097566A1 - 一种主动脉覆膜支架 - Google Patents

一种主动脉覆膜支架 Download PDF

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Publication number
WO2013097566A1
WO2013097566A1 PCT/CN2012/085211 CN2012085211W WO2013097566A1 WO 2013097566 A1 WO2013097566 A1 WO 2013097566A1 CN 2012085211 W CN2012085211 W CN 2012085211W WO 2013097566 A1 WO2013097566 A1 WO 2013097566A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
stent
trough
aortic
barb
Prior art date
Application number
PCT/CN2012/085211
Other languages
English (en)
French (fr)
Inventor
杨凡
郑炜
肖家华
Original Assignee
北京华脉泰科医疗器械有限公司
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 CN2011205651388U external-priority patent/CN202397655U/zh
Priority claimed from CN2011205647679U external-priority patent/CN202397646U/zh
Application filed by 北京华脉泰科医疗器械有限公司 filed Critical 北京华脉泰科医疗器械有限公司
Priority to BR112014016061A priority Critical patent/BR112014016061A8/pt
Priority to US14/369,650 priority patent/US20150018933A1/en
Priority to DE112012005518.7T priority patent/DE112012005518T5/de
Priority to GB1412068.7A priority patent/GB2512775A/en
Publication of WO2013097566A1 publication Critical patent/WO2013097566A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483Barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present invention relates to medical devices, and more particularly to an aortic stent graft. Background technique
  • distal refers to the end away from the heart in the direction of blood flow
  • proximal the end that is adjacent to the heart in the direction of blood flow
  • Aortic aneurysm refers to a local or diffuse abnormal expansion of the aortic wall, which causes the surrounding organs to cause symptoms, and the rupture of the tumor is its main risk. Often occurs in the ascending aorta, aortic arch, thoracic descending aorta, thoracic and abdominal aorta, and abdominal aorta.
  • the traditional surgical treatment is open-thoracic and open abdominal aortic resection and artificial vascular replacement.
  • the operation risk is high, and most of the lesions are not operable at all.
  • the mortality of the operation is high, which may cause serious diseases such as heart, brain and kidney dysfunction. disease. Since the 1990s, since the emergence of abdominal aortic aneurysm in the human body, it has quickly become the preferred treatment for active permanent tumors.
  • Aortic aneurysm endovascular surgery is to first perform CT angiography and other imaging examinations on patients with aortic aneurysm, obtain accurate data of aortic aneurysm, and then select or customize aortic stent grafts of appropriate caliber and length.
  • a small incision of 3 cm in the groin was performed. Under the fluoroscopy, the stent was delivered to the diseased aorta through the femoral artery through the corresponding delivery system, and then the stent was released from the catheter.
  • the released aortic stent graft is opened to the original caliber, and under the elastic force of the stent itself, it is attached to the aortic wall to cover the aortic lesion, and the membrane creates a new blood channel in the diseased blood vessel. Blocking the supply of fresh blood, the aortic aneurysm gradually forms a thrombus, thereby reducing the compression of the aortic aneurysm to surrounding tissues and organs, and eliminating the risk of major bleeding due to rupture of the aortic aneurysm.
  • Intracavitary isolation surgery is performed by moving away from the blood vessels of the lesion to avoid the lesion
  • the parasitic injury caused by anatomy; and the blocking time of blood flow during operation is extremely short, avoiding the complications of organ ischemia; in addition, the endovascular treatment of most central blood vessels can be performed under the condition of local anesthesia small incision, Reduced anesthesia requirements, greatly reduced surgical trauma, and accelerated postoperative recovery.
  • Patent document WO2004002370A1 discloses a thoracic aortic stent graft with a barb comprising a tubular coating material, a Z-shaped stent and a scaffold connected to the distal end of the stent graft, wherein the tubular coating material is near
  • the end Z-shaped bracket and the base bracket are provided with a barb structure for preventing and fixing.
  • the prior art is mainly applied to the aortic arch, and the stent graft is inserted into the aortic vessel wall through the proximal and distal barbs thereof.
  • Anchoring effectively prevents the proximal end of the stent body from moving toward the distal end and the distal end thereof moving toward the proximal end due to lateral forces generated by the blood flow to the curved stent graft.
  • the barbs may be separated from the vessel wall or may not be fully inserted into the vessel wall, and the same individual The inner diameter of the artery is not uniform.
  • the technical problem to be solved by the present invention is that the anchoring and fixing structure of the stent graft is not anchored in the prior art.
  • the present invention provides an aortic stent graft, comprising: a stent-covered stent and a wave-shaped scaffold connected to the proximal end of the stent graft, wherein the scaffold is provided with a detachment prevention structure away from the peak of the stent graft, wherein the stent is close to the membrane
  • Each trough of the stent is provided with a detachment prevention structure that extends toward the distal end of the stent graft.
  • the detachment prevention structure is an outwardly expanding barb structure, and the barb structure forms an expansion angle with a central axis of the pedestal, and the expansion angle is preferably greater than 30°.
  • the barb structure at each peak of the tree stand is set to two, and an angle is formed between the two barb structures.
  • the barb structure at each peak of the tree holder is set to one.
  • the barb structures at each trough of the tree stand are each provided in two, and the two barbs 5 structures are respectively located outside the support bars on both sides of each of the troughs.
  • the barb structure at each trough of the tree stand is set to one, and the barb structure is located outside the left side support bar at each trough.
  • the barb structure at each trough of the tree stand is set to one, and the barb structure is located outside the right side support bar at each trough.
  • the barb structure at each trough of the tree holder is set to one, and the barb structure is located on the outer surface of the shank to which the trough is connected to the connection hole.
  • the stent graft is composed of a main stent, a long branch stent and a short branch stent, and the length of the long branch stent is greater than the length of the short branch stent.
  • the aortic stent graft is an abdominal aortic stent graft.
  • a developing member for observing the position of the stent graft is provided on the green stent at a position close to the proximal end of the stent graft.
  • the developing member on the base bracket is disposed at a trough of the base bracket, and the connecting manner of the developing member and the base bracket is one of bonding, inlaying, socketing, welding, and coating.
  • a hole is further provided at a peak of the base bracket, and the tightening member controls the base bracket to expand and contract along the radial direction thereof through the through hole.
  • a connecting hole is further formed in the trough of the tree stent, and the connecting wire passes through the connecting hole and is connected to the film at the proximal end of the stent graft.
  • a developing member for observing the position of the stent graft is provided on the stent graft.
  • a developing member for recognizing a position at which the two branch intersections are located is sewn at a position of the film at the intersection of the long branch bracket and the short branch bracket.
  • a developing member for respectively marking each branch into a blood vessel position is sewn at a position of the film where the long branch bracket and the short branch bracket are located.
  • the scaffold of the present invention is provided with a detachment prevention structure near each trough of the stent graft, and when the aortic stent graft is fixed by the anti-detachment fixation structure, the trough prevention
  • the de-fixed structure is matched with the anti-de-fixation structure at the crest. Since the anti-de-fixation structure at the trough is not on the same plane as the anti-de-fixation structure at the crest, the two groups are prevented from being de-fixed with the relaxation and contraction movement of the aorta.
  • the structure is not easy to simultaneously move relative to each other to cause the detachment or relaxation of the anti-detachment structure, thereby enabling the aortic stent graft to be more firmly fixed on the blood vessel wall, further reducing the risk of covering the renal artery;
  • the present invention is provided with a plurality of perforations and tightening members for controlling the radial expansion and contraction of the base bracket, and the through holes are disposed at the peaks of the waveform of the base support, and the tightening members are The perforation is closed to make the stent radially contract, and then the aortic stent graft is compressed into the thinner tube to be transported into the human body, so that the operation of shrinking the stent graft into the conveyor during operation is more convenient;
  • the developing member is directly disposed on the green bracket, compared to sewing the developing member
  • the design on the film reduces the volume after compression, thereby reducing the volume of the required conveyor, facilitating the movement of the conveyor in the aorta and the release of the stent graft; further, the developing component is placed at The trough of the stent is closer to the position of the stent graft, which can more accurately indicate the position of the stent graft;
  • the present invention is respectively connected with a developing member at the proximal end of the main body bracket, at the intersection of the two branch brackets, and at the film covering position on the two branch brackets.
  • FIG. 1 is a schematic view of a abdominal aortic stent graft according to Embodiment 1 of the present invention
  • FIG. 2 is a schematic view showing a stent of an abdominal aortic stent graft according to Embodiment 1 of the present invention
  • the abdominal aortic stent graft of the first embodiment comprises a main stent 2 consisting of 5 wavy cylindrical single circles, and a long branch stent 4 consisting of 6 wavy cylindrical singles.
  • the short branch bracket 5 is composed of three wavy cylindrical single rings; the main bracket 2, the long branch bracket 4 is connected with the short branch bracket 5, and is sewn to form a film on the film 3 adapted to its shape.
  • the stent wherein the main stent 2 and the long branch stent 4 are respectively sewn on the outer side of the film 3, and the short branch stent 5 is sewn on the inner side of the film 3.
  • the support 1 is composed of a wavy cylindrical single ring having a wave number of 5, and each of the columnar single turns is formed with an annular perforation 6 at a peak away from the stent graft, and is used for retracting the stent after threading.
  • each of the columnar single turns is formed with an annular connecting hole 8 for connecting the base support 1 to the proximal end of the stent graft after threading; each of the green stents 1 is away from the membrane
  • a barb structure 7 having an angle of expansion of 45° and extending toward the distal end of the stent graft is disposed at the crest of the stent and at each trough near the stent graft, wherein each of the peaks away from the stent graft
  • the angle between the two barb structures 7 is 30°, and each of the two barb structures 7 near the troughs of the stent graft is located outside the support rods 10 on both sides of the trough, and faces the stent graft.
  • the handle of the three consecutive annular connecting holes 8 of the green support 1 is provided with a strip-shaped developing member 9, preferably in the form of a hoop or a bonding;
  • a " ⁇ "-shaped developing member 9 is sewn; on the film 3 at the intersection of the long branch holder 4 and the short branch holder 5 A developing member 9 is sewn;
  • a developing member 9 is sewn on the film 3 at the distal end of the long branch holder 4 and the film 3 at the distal end of the short branch holder 5; all of the columnar single-ring materials are nickel-titanium alloy ( Ni t inol ) , the material of the film 3 is polyethylene terephthalate (PET).
  • Ni t inol nickel-titanium alloy
  • PET polyethylene terephthalate
  • the abdominal aorta stent graft of the second embodiment adopts the base bracket 1 as shown in FIG.
  • the trough of the stent 1 is sewn together with the proximal membrane 3 of the stent graft; each of the scaffolds 1 is provided with two dilatation angles of 45° and facing toward the peak of the stent graft.
  • a barb structure 7 extending distally of the membrane stent, wherein the angle between the two barb structures 7 is 30°, and the outer side of the left support rod at each trough of the green stent 1 near the stent graft is A barb structure 7 having an expansion angle of 45 ° and extending toward the distal end of the stent graft was provided, and the rest of the structure and material were the same as in the first embodiment.
  • the abdominal aorta stent graft of the third embodiment adopts a tree stent 1 as shown in FIG. 5, and the trough of the tree stent 1 is sewn together with the proximal membrane 3 of the stent graft;
  • Each of the peaks away from the stent graft is provided with two barb structures 7 having an angle of expansion of 45° and extending toward the distal end of the stent graft, and the angle between the two barb structures 7 is 30°.
  • the outer side of the right side support rod at each trough of the scaffold 1 near the stent graft is provided with a barb structure 7 having an expansion angle of 45 ° and extending toward the distal end of the stent graft, and the rest of the structure
  • the material was the same as in Example 1.
  • the abdominal aortic stent graft of the fourth embodiment adopts a tree stent 1 as shown in FIG. 6 , and the trough of the tree stent 1 is sewn together with the proximal membrane 3 of the stent graft;
  • Each of the peaks away from the stent graft is provided with two barb structures 7 having an angle of expansion of 45° and extending toward the distal end of the stent graft, wherein the angle between the two barb structures 7 is 30° a barb structure having an expansion angle of 45° and extending toward the distal end of the stent graft is disposed on an outer surface of the shank of the tree stent 1 adjacent to the connection hole 8 at each trough of the stent graft 1 7.
  • the rest of the structure and materials are the same as in the first embodiment.
  • the abdominal aorta stent graft of the fifth embodiment adopts a tree stent 1 as shown in FIG. 7 , and the trough of the tree stent 1 is sewn together with the proximal membrane 3 of the stent graft; 1
  • Each of the crests away from the stent graft is provided with a barb structure 7 having an expansion angle of 45 ° and extending toward the distal end of the stent graft, which is located near each trough of the stent graft
  • the outside of the support rods on both sides is provided with a barb structure 7 having an expansion angle of 45 ° and extending toward the distal end of the stent graft, and the rest of the structure and material are the same as in the first embodiment.
  • the abdominal aortic stent graft of the sixth embodiment uses a tree stent 1 as shown in FIG. 8 , and the trough of the tree stent 1 is sewn together with the proximal membrane 3 of the stent graft; Each of the stents 1 is provided with an expansion angle of 45 at a peak away from the stent graft. And a barb structure 7 extending toward the distal end of the stent graft, the outer side of the right side support rod of each of the troughs near the stent graft is provided with an expansion angle of 45. And the barb structure 7 extending toward the distal end of the stent graft, the rest of the structure and material are the same as in the first embodiment.
  • the abdominal aortic stent graft of the seventh embodiment uses a tree stent 1 as shown in FIG. 9 , and the trough of the tree stent 1 is sewn together with the proximal membrane 3 of the stent graft; Each of the stents 1 is provided with an expansion angle of 45 at a peak away from the stent graft. And a barb structure 7 extending toward the distal end of the stent graft, the outer side of the left side support rod at each trough of the green stent 1 near the stent graft is provided with an expansion angle of 45. And the barb structure 7 extending toward the distal end of the stent graft, the rest of the structure and material are the same as in the first embodiment.
  • the abdominal aortic stent graft of the eighth embodiment uses the scaffold 1 shown in FIG. 10, and the trough of the scaffold 1 is sewn together with the proximal membrane 3 of the stent graft; Each of the stents 1 is provided with an expansion angle of 45 at a peak away from the stent graft. And a barb structure 7 extending toward the distal end of the stent graft, wherein each of the troughs of the tree stent 1 adjacent to the stent graft is provided with an expansion angle of 45 on the outer surface of the handle connected to the connection hole 8.
  • the barb structure 7 extends toward the distal end of the stent graft, and the rest of the structure and material are the same as in the first embodiment.

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

Abstract

一种能避免移位的主动脉覆膜支架,包括:覆膜支架和与所述覆膜支架近端相连接的裸支架(1)以及设置于所述裸支架的每个波峰处和每个波谷处的用于防脱固定的倒钩结构(7),其中所述倒钩结构(7)朝向所述覆膜支架的远端延伸。当通过所述防脱固定结构(7)将主动脉覆膜支架固定后,由于裸支架(1)的每个波峰处和每个波谷处的倒钩结构(7)不在同一平面上,因此两组倒钩不容易同时发生相对运动而导致防脱固定结构(7)的脱落或松弛,从而使主动脉覆膜支架能够更牢固地固定在血管壁上。

Description

说 明 书 一种主动脉覆膜支架
技术领域 本发明涉及医疗器械, 尤其涉及一种主动脉覆膜支架。 背景技术
本发明中, 术语 "远端,, 指沿血流方向远离心脏的一端, "近端,, 指沿血流方向靠近心脏的一端。
主动脉瘤指主动脉壁局部或弥漫性的异常扩张, 压迫周围器官而引 起症状, 瘤状破裂为其主要危险。 常发生在升主动脉、 主动脉弓、 胸部 降主动脉、 胸腹主动脉和腹主动脉。 传统的手术治疗方法为开胸、 开腹 行病变主动脉切除人工血管置换术, 手术风险大, 而且多数病变根本不 能手术, 手术病死率高, 易引起心、 脑、 肾功能不全等严重病发症。 20 世纪 90年代以后, 自从人体腹主动脉瘤腔内隔绝术出现, 它就很快成为 主动永瘤的首选治疗方法。
主动脉瘤腔内隔绝术就是先对主动脉瘤患者进行 CT动脉造影等影 像学检查, 获得主动脉瘤的精确数据, 然后据此选择或定制口径和长度 适合的主动脉覆膜支架。 手术时, 在腹股沟部位做 3cm长的小切口, 在 X 线透视监视下 , 通过相应的输送***经股动脉将支架送到病变主动脉部 位, 然后将支架从导管内释放。 释放后的主动脉覆膜支架张开至原来口 径, 并在支架本身弹力作用下, 贴附在主动脉管壁上覆盖住主动脉病变 部分, 覆膜在病变血管中制造出新的血液通道, 阻断其获得新鲜血液供 应, 使主动脉瘤逐渐形成血栓, 从而减轻主动脉瘤对周围组织、 器官的 压迫, 并消除由于主动脉瘤破裂造成大出血的危险。
腔内隔绝手术经远离病变部位的血管进行操作避免了病变区域的 解剖带来的副损伤; 并且操作过程中对血流的阻断时间极短, 避免了脏 器缺血并发症; 此外, 多数中心型血管的腔内治疗能在局部麻醉小切口 条件下进行, 降低了麻醉要求, 极大的减少了手术创伤, 加速了术后恢 复过程。 这些优点使其成为目前主动脉瘤的首选治疗方法, 但是目前这 种主动脉瘤腔内隔绝术仍存在一定的问题, 比如容易发生支架移位, 这 也是导致治疗失败和出现远期并发症的原因之一 , 其可以通过合理的选 择和改进支架来解决。
专利文献 W02004002370A1公开了一种带有倒钩的胸主动脉覆膜支 架, 包括管状的覆膜材料、 Z形支架和与覆膜支架远端相连接的棵支架 组成, 其中在管状覆膜材料近端的 Z形支架和所述棵支架上设置有用于 防脱固定的倒钩结构, 该现有技术主要应用于主动脉弓处, 覆膜支架通 过其近端和远端的倒钩***主动脉血管壁进行锚定, 有效地防止了由 于血液流动对弯曲的覆膜支架产生的横向力所造成的支架主体的近端 朝向远端的移动和其远端朝向近端的移动。 但是随着主动脉的舒缩运 动, 覆膜支架与设于其上的倒钩会相对血管壁进行运动, 则倒钩可能会 脱离开血管壁或者不能完全***到血管壁上, 且同一个体主动脉的内径 不均一, 当所选择的覆膜支架倒钩的直径尺寸不适合锚定处主动脉的内 径时, 仅靠覆膜支架近端设置的一组倒钩结构无法完全锚定住覆膜支 架, 特别是当覆膜支架应用于腹主动脉时, 由于腹主动脉与肾动脉相连 接, 覆膜支架脱落后, 其覆膜容易覆盖肾动脉阻挡腹主动脉与肾动脉之 间的血液流动, 从而给患者的生命带来危险。 发明内容
本发明所要解决的技术问题是现有技术中覆膜支架的防脱固定结 构锚定不牢固的问题。
为解决上述技术问题, 本发明提供了一种主动脉覆膜支架, 包括: 覆膜支架和与所述覆膜支架近端相连接的波浪形的棵支架, 所述棵支架 远离覆膜支架的波峰处设置有防脱固定结构, 其特征在于, 所述棵支架 靠近覆膜支架的每个波谷处均设置有防脱固定结构, 所述防脱固定结构 朝向所述覆膜支架的远端延伸。
所述防脱固定结构为向外扩张的倒钩结构, 所述倒钩结构同所述棵 支架的中轴形成一扩张角, 所述扩张角优选为大于 30° 。
所述棵支架的每个波峰处的倒钩结构均设置为两个, 且两个所述倒 钩结构之间形成一夹角。
所述棵支架的每个波峰处的倒钩结构均设置为一个。
所述棵支架的每个波谷处的倒钩结构均设置为两个, 且两个所述倒 钩 5 结构分别位于所述每个波谷的两侧支撑杆的外侧。
所述棵支架的每个波谷处的倒钩结构均设置为一个, 且所述倒钩结 构位于每个波谷处的左侧支撑杆的外侧。
所述棵支架的每个波谷处的倒钩结构均设置为一个, 且所述倒钩结 构位于每个波谷处的右侧支撑杆的外侧。
所述棵支架的每个波谷处的倒钩结构均设置为一个, 且所述倒钩结 构位于波谷与连接孔相连接的柄部的外表面上。
所述覆膜支架由主支架、 长分支支架和短分支支架连接组成, 所述 长分支支架的长度大于所述短分支支架的长度。
所述的主动脉覆膜支架为腹主动脉覆膜支架。
所述棵支架上靠近所述覆膜支架近端的位置设有用于观察所述覆 膜支架位置的显影部件。
所述棵支架上的显影部件设置在所述棵支架的波谷处, 所述显影部 件与所述棵支架的连接方式为粘接、镶嵌、套接、焊接、涂布中的一种。 所述棵支架的波峰处还设有穿孔, 收紧部件通过所述穿孔控制所述 棵支架沿其径向伸缩。
所述收紧部件为金属线、 丝线、 棉线、 塑料线、 麻线中的一种, 所 述穿孔可供所述收紧部件穿过后收紧, 用于将所述棵支架收拢。
所述棵支架的波谷处还成型有连接孔 , 连接线由所述连接孔中穿过 并同所述覆膜支架近端的覆膜相连接。
所述覆膜支架上设有用于观察所述覆膜支架位置的显影部件。 所述长分支支架和短分支支架的交叉连接处的覆膜位置上缝制有 用于辨识两分支交叉点所处位置的显影部件。
所述长分支支架和短分支支架所在的覆膜位置上分别缝制有用于 分别标识各分支进入血管位置的显影部件。
与现有技术相比, 本发明的优点是:
( 1 )本发明所述棵支架靠近覆膜支架的每个波谷处均设置有一个 防脱固定结构, 当通过所述防脱固定结构将主动脉覆膜支架固定后, 所 述波谷处的防脱固定结构与波峰处的防脱固定结构相配合, 由于波谷处 的防脱固定结构与波峰处的防脱固定结构不在同一平面上, 因此随着主 动脉的舒缩运动, 两组防脱固定结构不容易同时发生相对运动而导致防 脱固定结构的脱落或松弛, 进而使主动脉覆膜支架能够更牢固地固定在 血管壁上, 进一步减少了覆盖肾动脉的风险;
( 2 )本发明在所述棵支架上设有多个用于控制所述棵支架径向伸 缩的穿孔以及收紧部件, 所述穿孔设置于所述棵支架波形的波峰处, 通 过收紧部件收拢穿孔使棵支架径向收缩, 再将主动脉覆膜支架压缩进管 径较细的输送器送入人体内, 这样使手术时覆膜支架收缩置入输送器的 操作更为方便;
( 3 )所述显影部件直接设置在棵支架上, 相比于将显影部件缝在 覆膜上的设计, 减小了压缩后的体积, 从而减小了所需输送器的体积, 方便了输送器在主动脉中的移动与覆膜支架的释放; 进一步地, 将显影 部件设置在棵支架的波谷处, 距离覆膜支架的位置更近, 可以更确切地 指示覆膜支架的位置;
( 4 )本发明在所述主体支架的近端、 两分支支架的交叉处、 两分 支支架上的覆膜位置处分别连接有显影部件, 在主动脉覆膜支架进入人 体后, 可以通过观察上述显影部件的位置来判断支架主体、 两分支支架 交叉点、 两分支支架所处的位置, 以便于手术的操作。 附图说明
为了使本发明的内容更容易被清楚的理解, 下面结合附图和实施例 对本发明进一步说明, 其中
图 1为本发明实施例 1中腹主动脉覆膜支架的示意图;
图 2为本发明实施例 1中腹主动脉覆膜支架的棵支架示意图;
其中, 附图标记为:
1-棵支架, 2-主支架, 3-覆膜, 4-长分支支架, 5-短分支支架, 6- 穿孔, 7-倒钩结构, 8-连接孔, 9-显影部件, 1 0-支撑杆。 具体实施方式 实施例 1
如图 1、 2和 3所示为第一种实施方式的腹主动脉覆膜支架, 包括 主支架 2由 5个波浪形的柱状单圈组成, 长分支支架 4由 6个波浪形的 柱状单圈组成, 短分支支架 5由 3个波浪形的柱状单圈组成; 主支架 2、 长分支支架 4与短分支支架 5相连接后缝制在与其形状相适配的覆膜 3上 形成覆膜支架, 其中主支架 2、 长分支支架 4分别缝制在覆膜 3的外侧, 短分支支架 5缝制在覆膜 3的内侧。
棵支架 1由 1个波浪形的柱状单圈组成, 波数为 5, 其柱状单圈的每 个远离覆膜支架的波峰处成型有环状的穿孔 6 , 用于穿丝线后收放覆膜 支架的体积; 其柱状单圈的每个波谷处成型有环状的连接孔 8 , 用于穿 线后将棵支架 1与覆膜支架的近端相连接; 所述棵支架 1的每一个远离覆 膜支架的波峰处与每一个靠近覆膜支架的波谷处均设置有两个扩张角 为 45° 并朝向覆膜支架远端延伸的倒钩结构 7 , 其中, 每一个远离覆膜 支架的波峰处的两个倒钩结构 7的夹角为 30° , 每一个靠近覆膜支架的 波谷处的两个倒钩结构 7分别位于所述波谷处的两侧支撑杆 10的外侧, 并朝向覆膜支架的远端延伸; 作为进一步改进的实施方式, 在棵支架 1 三个连续的环状连接孔 8的柄部设有有一个条状的显影部件 9 , 优选为以 箍或粘接的方式来设置;在主支架 2近端首个柱状单圈的第一个波谷(从 左向右)的下部的覆膜 3上, 缝制有一个 " Δ " 形的显影部件 9; 在长分 支支架 4与短分支支架 5交叉处的覆膜 3上缝有显影部件 9; 在长分支支架 4远端的覆膜 3上和短分支支架 5远端的覆膜 3上分别缝有一个显影部件 9; 所有柱状单圈的材料均为镍钛合金(Ni t inol ) , 覆膜 3的材料为聚 对苯二曱酸乙二酯 (PET ) 。
实施例 2
第二种实施方式的腹主动脉覆膜支架采用如图 4所示的棵支架 1 , 所 述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起; 所述棵支架 1 的每一个远离覆膜支架的波峰处均设置有两个扩张角为 45 ° 并朝向覆 膜支架远端延伸的倒钩结构 7 , 其中所述两个倒钩结构 7的夹角为 30° , 所述棵支架 1的靠近覆膜支架的每个波谷处的左侧支撑杆的外侧均设置 有一个扩张角为 45 ° 并朝向覆膜支架远端延伸的倒钩结构 7 , 其余部分 的结构与材料与实施例 1相同。
实施例 3
第三种实施方式的腹主动脉覆膜支架采用如图 5所示的棵支架 1 , 所 述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起; 所述棵支架 1 的每一个远离覆膜支架的波峰处均设置有两个扩张角为 45 ° 并朝向覆 膜支架远端延伸的倒钩结构 7 , 且所述两个倒钩结构 7的夹角为 30° , 所 述棵支架 1的靠近覆膜支架的每个波谷处的右侧支撑杆的外侧均设置有 一个扩张角为 45 ° 并朝向覆膜支架远端延伸的倒钩结构 7 , 其余部分的 结构与材料与实施例 1相同。
实施例 4
第四种实施方式的腹主动脉覆膜支架采用如图 6所示的棵支架 1 , 所 述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起; 所述棵支架 1 的每一个远离覆膜支架的波峰处均设置有两个扩张角为 45 ° 并朝向覆 膜支架远端延伸的倒钩结构 7 , 其中所述两个倒钩结构 7的夹角为 30° , 所述棵支架 1的靠近覆膜支架的每个波谷处与连接孔 8相连接的柄部的 外表面上均设置有一个扩张角为 45 ° 并朝向覆膜支架远端延伸的倒钩 结构 7 , 其余部分的结构与材料与实施例 1相同。
实施例 5
第五种实施方式的腹主动脉覆膜支架采用如图 7所示的棵支架 1 , 所 述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起; 所述棵支架 1 的每一个远离覆膜支架的波峰处均设置有 1个扩张角为 45 ° 并朝向覆膜 支架远端延伸的倒钩结构 7 , 所述棵支架 1的靠近覆膜支架的每个波谷处 的两侧支撑杆的外侧均设置有 1个扩张角为 45 ° 并朝向覆膜支架远端延 伸的倒钩结构 7 , 其余部分的结构与材料与实施例 1相同。
实施例 6
第六种实施方式的腹主动脉覆膜支架釆用如图 8所示的棵支架 1 , 所述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起;所述棵支 架 1的每一个远离覆膜支架的波峰处均设置有 1个扩张角为 45。 并朝 向覆膜支架远端延伸的倒钩结构 7 ,所述棵支架 1的靠近覆膜支架的每 个波谷处的右侧支撑杆的外侧均设置有一个扩张角为 45。 并朝向覆 膜支架远端延伸的倒钩结构 7 , 其余部分的结构与材料与实施例 1相 同。
实施例 7
第七种实施方式的腹主动脉覆膜支架釆用如图 9所示的棵支架 1 , 所述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起;所述棵支 架 1的每一个远离覆膜支架的波峰处均设置有 1个扩张角为 45。 并朝 向覆膜支架远端延伸的倒钩结构 7 ,所述棵支架 1的靠近覆膜支架的每 个波谷处的左侧支撑杆的外侧均设置有一个扩张角为 45。 并朝向覆 膜支架远端延伸的倒钩结构 7 , 其余部分的结构与材料与实施例 1相 同。
实施例 8
第八种实施方式的腹主动脉覆膜支架釆用如图 10所示的棵支架 1 , 所述棵支架 1的波谷处与覆膜支架的近端覆膜 3缝制在一起; 所述 棵支架 1的每一个远离覆膜支架的波峰处均设置有 1个扩张角为 45。 并朝向覆膜支架远端延伸的倒钩结构 7 ,所述棵支架 1的靠近覆膜支架 的每个波谷处与连接孔 8相连接的柄部的外表面上均设置有一个扩张 角为 45° 并朝向覆膜支架远端延伸的倒钩结构 7 , 其余部分的结构与 材料与实施例 1相同。
显然, 上述实施例仅仅是为清楚地说明所作的举例, 而并非对实 施方式的限定。对于所属领域的普通技术人员来说, 在上述说明的基 础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有 的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处 于本发明的保护范围之中。

Claims

权 利 要 求 书
1. 一种主动脉覆膜支架, 包括:
覆膜支架和与所述覆膜支架近端相连接的波浪形的棵支架,所述 棵支架远离覆膜支架的波峰处设置有防脱固定结构, 其特征在于, 所 述棵支架靠近覆膜支架的每个波谷处均设置有防脱固定结构,所述防 脱固定结构朝向所述覆膜支架的远端延伸。
2. 根据权利要求 1所述的主动脉覆膜支架, 其特征在于, 所述防脱固定结构为向外扩张的倒钩结构,所述倒钩结构同所述 棵支架的中轴所形成的扩张角大于 30。 。
3. 根据权利要求 2所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波峰处的倒钩结构均设置为两个,且两个所述 倒钩结构之间形成一夹角。
4. 根据权利要求 2所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波峰处的倒钩结构均设置为一个。
5. 根据权利要求 3或 4所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处的倒钩结构均设置为两个,且两个所述 倒钩结构分别位于所述每个波谷的两侧支撑杆的外侧。
6. 根据权利要求 3或 4所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处的倒钩结构均设置为一个,且所述倒钩 结构位于所述每个波谷处的左侧支撑杆的外侧。
7. 根据权利要求 3或 4所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处的倒钩结构均设置为一个,且所述倒钩 结构位于所述每个波谷处的右侧支撑杆的外侧。
8. 根据权利要求 3或 4所述的主动脉覆膜支架, 其特征在于, 所 述棵支架的每个波谷处的倒钩结构均设置为一个,且所述倒钩结构位 于波谷与连接孔相连接的柄部的外表面上。
9. 根据权利要求 1 ~ 4中任一所述的主动脉覆膜支架, 其特征在 于,
所述覆膜支架由主支架、 长分支支架和短分支支架连接组成, 所
10. 根据权利要求 9所述的主动脉覆膜支架, 其特征在于, 所述主动脉覆膜支架为腹主动脉覆膜支架。
11. 根据权利要求 1所述的主动脉覆膜支架, 其特征在于, 所述棵支架上靠近所述覆膜支架近端的位置设有用于观察所述 覆膜支架位置的显影部件。
12. 根据权利要求 11所述的主动脉覆膜支架, 其特征在于, 所述棵支架上的显影部件设置在所述棵支架的波谷处,所述显影 部件与所述棵支架的连接方式为粘接、 镶嵌、 套接、 焊接、 涂布中的 一种。
1 3. 根据权利要求 12所述的主动脉覆膜支架, 其特征在于, 所述防脱固定结构为向外扩张的倒钩结构,所述倒钩结构同所述 棵支架的中轴形成一扩张角。
14. 根据权利要求 1 3所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处均设置有两个倒钩结构,且两个所述倒 钩结构分别位于所述每个波谷的两侧支撑杆的外侧。
15. 根据权利要求 1 3所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处均设置有一个倒钩结构,且所述倒钩结 构位于所述每个波谷处的左侧支撑杆的外侧。
16. 根据权利要求 1 3所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处均设置有一个倒钩结构,且所述倒钩结 构位于所述每个波谷处的右侧支撑杆的外侧。
17. 根据权利要求 1 3所述的主动脉覆膜支架, 其特征在于, 所述棵支架的每个波谷处均设置有一个倒钩结构,且所述倒钩结 构位于波谷与连接孔相连接的柄部的外表面上。
18. 根据权利要求 11 ~ 17中任一所述的主动脉覆膜支架, 其特征 在于,
所述棵支架的每个波峰处设置有两个倒钩结构,且两个所述倒钩 结构之间形成一夹角。
19. 根据权利要求 11 ~ 17中任一所述的主动脉覆膜支架, 其特征 在于,
所述棵支架的每个波峰处设置有一个倒钩结构。
20. 根据权利要求 11 ~ 17中任一所述的主动脉覆膜支架, 其特征 在于,
所述覆膜支架由主支架、 长分支支架和短分支支架连接组成, 所
21. 根据权利要求 11 ~ 17所述的主动脉覆膜支架, 其特征在于, 所述主动脉覆膜支架为腹主动脉覆膜支架。
PCT/CN2012/085211 2011-12-29 2012-11-23 一种主动脉覆膜支架 WO2013097566A1 (zh)

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US14/369,650 US20150018933A1 (en) 2011-12-29 2012-11-23 Aortic stent-graft
DE112012005518.7T DE112012005518T5 (de) 2011-12-29 2012-11-23 Ein Aorten-Stent-Graft
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