WO2010105561A1 - 侧支型覆膜支架 - Google Patents

侧支型覆膜支架 Download PDF

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Publication number
WO2010105561A1
WO2010105561A1 PCT/CN2010/071099 CN2010071099W WO2010105561A1 WO 2010105561 A1 WO2010105561 A1 WO 2010105561A1 CN 2010071099 W CN2010071099 W CN 2010071099W WO 2010105561 A1 WO2010105561 A1 WO 2010105561A1
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WO
WIPO (PCT)
Prior art keywords
bracket
main body
stent
body portion
side branch
Prior art date
Application number
PCT/CN2010/071099
Other languages
English (en)
French (fr)
Inventor
朱清
罗七一
袁振宇
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 US13/254,010 priority Critical patent/US8961587B2/en
Priority to BRPI1006233A priority patent/BRPI1006233A8/pt
Priority to GB1114315.3A priority patent/GB2480570B/en
Publication of WO2010105561A1 publication Critical patent/WO2010105561A1/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
    • A61F2/82—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • the present invention relates to a medical device for minimally invasive intervention for the treatment of aortic diseases, and in particular to a side-supporting stent graft. Background technique
  • stent grafts for the treatment of aortic diseases has been a major advance in aortic surgery.
  • Indications include aortic dissection aneurysms, aortic true aneurysms, aortic pseudoaneurysms, and aortic penetrability. Ulcers, etc.
  • the application of this technology greatly reduces the mortality of conventional surgical treatment and postoperative complications, reduces the surgical trauma, and the patient recovers faster.
  • the mechanism is to open the stent graft after the lesion is opened, so that the tumor is isolated from the blood, thereby eliminating the risk of death caused by the rupture of the aneurysm, or eliminating the surrounding tissue and organs of the tumor.
  • the oppression At present, there are mature products at home and abroad, such as foreign talent, AneuRex, Exclude, Relay and Gore, as well as domestic Hercules, Aegis and Ankura.
  • a stent graft with collaterals is expected to eliminate the above-mentioned patients from conventional surgical treatment, and the main body and branch portions of the stent can be used to repair lesions of the aorta and branch arteries, respectively.
  • CN201131823Y discloses an intra-arterial stent with lateral branches, but the main body and lateral branches The frame structure is single and cannot adapt to the variable blood vessel shape;
  • CN101015478A also discloses a side branch type stent graft, wherein the side branch portion is connected with the main body portion through a soft joint portion, and the main body and the side branch portion are respectively used for the aorta and
  • the left subclavian artery can simultaneously ensure the blood supply to the aorta and the left subclavian artery, but the soft joint at the proximal end of the collateral will cause occlusion of the left subclavian artery if released poorly (such as when twisted or discounted).
  • An object of the present invention is to provide a side-supporting stent graft which is structurally stable and has good bending properties and is suitable for treating aortic diseases involving a branch artery (e.g., aortic aneurysm), and its use state is shown in Fig. 1.
  • aortic diseases involving a branch artery e.g., aortic aneurysm
  • the side support type stent graft provided by the invention comprises a main body portion and a side branch portion, and the main body portion and the side branch portion each comprise a bracket and a tubular film which is sutured with the bracket, and the film of the side branch portion and the film portion of the main body portion Stitching, the stent of the body portion includes a plurality of stent segments, at least one of which is a heightening stent segment; the stent of the side branch portion includes one or more stent segments, at least one of which is a high stent segment, and a side branch
  • the distance between the part of the most proximal support section and the main part is 2-8 mm; the height of the bracket section means that all the troughs of the waveform are on the same horizontal line after the cylindrical single circle forming the bracket section is deployed, and all the peaks are not They are all on the same level.
  • the high-profile stent segments of the body portion and/or the side branch portions have a cylindrical single-turn unfolded waveform as shown in one or more of FIG.
  • the body portion includes at least one contour bracket segment, and the contour bracket segment refers to a cylindrical single ring that forms the stent segment, and all the troughs of the waveform are on the same horizontal line, and all the peaks are also On the same level.
  • the contour bracket segment refers to a cylindrical single ring that forms the stent segment, and all the troughs of the waveform are on the same horizontal line, and all the peaks are also On the same level.
  • the proximal end and/or the most distal stent segment of the body portion is a contoured stent segment.
  • the number of the side branch portions is 1, 2 or 3.
  • the stent section of the side branch portion is sewn outside the membrane.
  • the stent portion of the body portion is sewn into the membrane, or the stent segments of the proximal and distal ends of the body portion are sewn into the membrane, and the stent segments of the intermediate portion are sewn outside the membrane.
  • the body portion has a film length of 40-133 mm and a diameter of 16-36 mm.
  • the total number of stent segments is 3-7, the spacing of stent segments is 1-5 mm, the length of the lateral branches is 13-30 mm, the diameter is 6-14 mm, and the total number of stent segments is 1-2.
  • the distance between the segments is 1-5 mm, and the distance between the proximal end of the side branch portion and the main body portion is 2-4 mm.
  • the body portion and the side branch portion are further sewn with a development point.
  • a positioning ring is used at the side hole connecting the side branch portion and the body portion, and the positioning ring is sewn in the main body film, between the main body film and the side branch film or the side branch film, the positioning ring
  • the shape is shown in one of the figures in FIG.
  • the positioning ring has a flange 100 disposed in an axial direction of the body portion.
  • the stent uses materials having good biocompatibility and support, such as shape memory alloy, 316L medical stainless steel, nickel based alloy (such as nickel titanium wire), cobalt based alloy material or high degradable or non-degradable material. Made of molecular materials, etc.
  • the film is made of a biocompatible polymer material such as polytetrafluoroethylene, polyester fiber woven fabric, polyamide woven fabric, polypropylene woven fabric or the like.
  • a biocompatible polymer material such as polytetrafluoroethylene, polyester fiber woven fabric, polyamide woven fabric, polypropylene woven fabric or the like.
  • the development dot is made of platinum rhodium alloy, pure platinum, pure gold, NiTi shape memory alloy or stainless steel.
  • the positioning ring is made of a metal or non-metal material such as nickel titanium wire, stainless steel wire, nylon, polyurethane or the like.
  • Proximal refers to the side of the stent graft near the heart
  • Distal refers to the side of the stent graft away from the heart
  • a wave crest refers to a single waveform of a stent segment that faces the most convex portion at the proximal end;
  • the trough refers to the single convex shape of the stent segment toward the most convex portion of the distal end;
  • the distance between the most proximal stent segment and the body portion of the side branch portion refers to the shortest distance between the most convex peak and the body portion of the stent segment toward the proximal end;
  • the spacing of the stent segments refers to the distance between adjacent stent segments, specifically, the shortest between the most convex peak of a stent segment toward the proximal end and the plane of all the valleys of the adjacent proximal stent segment.
  • the side hole refers to the opening where the side branch portion is connected to the main body portion.
  • the side-supporting stent graft of the present invention has an integral design of the main body portion and the side branch portion, which is advantageous for reducing the difficulty of alignment and positioning during the implantation process, and also avoids the risk of leakage inside the joint portion.
  • the heightening of the stent section used in the main body facilitates the adaptation of the main body to the distortion of the aorta in different directions in the three-dimensional direction.
  • the heightened stent section used in the side branch portion and the 2-8 mm gap between the stent section and the body portion at the proximal end of the side branch portion facilitate the 360° free rotation of the side branch, and the side branch portion is adapted to the aortic side branch. Distortion of different shapes in the three-dimensional direction, at the same time, it is beneficial to fully open the stent, avoiding poor blood flow at the branch vessel, causing thrombosis, causing risk of insufficient blood supply or embolism of the blood vessels in the brain.
  • the design of the side branch is also beneficial to increase the subject.
  • the anchoring force of the stent achieves effective sealing of the aneurysm.
  • Designing a contour bracket at the proximal end and the farthest end of the main body facilitates the stent to adhere well, effectively reducing the risk of endoleaking.
  • the number of collaterals can be designed as 1, 2 or 3 according to actual needs, where a single branch can be used for the innominate artery or the left clavicular artery, and the bilateral branch can be used to involve the innominate artery and the left common carotid artery, or involve the left common carotid artery.
  • the three collaterals can be used in cases where the tumor involves the innominate artery, the left common carotid artery, and the left subclavian artery.
  • the stent segment of the collateral part is sewn outside the membrane, which helps to maximize the preservation of the blood flow channels of the collateral vessels and reduces the risk of thrombosis.
  • the bracket section of the main body part is sewn into the film, which is beneficial to improve the adhesion property of the film, reduce the risk of endoleak, or the part near the end and the distal end of the main body is sewn into the film, which is beneficial to improve the adhesion property of the film.
  • the stent segment of the main stent segment is sewn outside the membrane in the middle portion, which is beneficial to reduce the risk of thrombosis.
  • the developing part is stitched with the developing part to facilitate precise positioning of the main body and the side branch during the introduction process, so as to prevent the branching of the branch from being poorly connected or even closed.
  • a positioning ring at the side hole is beneficial to enhance the ability of the side hole to open, so that the side branch maintains a smooth path, avoiding the risk of the side branch being unable to fully open due to adverse effects such as blood vessel distortion or calcification at the interface.
  • the collateral stent graft of the present invention can be used for the treatment of ascending aortic aneurysm, aneurysm of the arch, descending aortic aneurysm and its dissection.
  • the stent can be implanted simultaneously with the aorta and branch arteries (eg, the left subclavian artery, the left common carotid artery, or the innominate artery) to treat a dissection rupture and an aneurysm involving the ascending aortic aneurysm, the aortic arch, and the descending aortic aneurysm, and the present invention eliminates
  • the aorta and branch arteries eg, the left subclavian artery, the left common carotid artery, or the innominate artery
  • Figure 1 is a schematic view showing the use state of the side-supporting stent graft of the present invention
  • Figure 2 is a schematic view of the preferred heightening bracket section after deployment
  • Figure 3 is a schematic view of a positioning ring
  • Figure 4 is a schematic view of the side-supporting stent graft of Example 1;
  • Figure 5 is a schematic view of a side-supporting stent graft of Example 2.
  • Figure 6 is a schematic view showing the stent segment of the side-supporting stent graft of Examples 1 and 2 after deployment;
  • Figure 7 is a schematic view of the side-supporting stent graft of Example 3;
  • Figure 8 is a schematic view showing the stent segment of the side-supporting stent graft of Example 3 after deployment;
  • Figure 9 is an angiogram of the animal test of the side-supporting stent graft of Example 1.
  • Fig. 10 is an angiogram of the animal test of the side-supporting stent graft of Example 2. detailed description
  • Example 1 Single-sided stent graft (see Figures 4 and 6)
  • the material of the main body film is polyester fiber textile, the length is 40 mm, the diameter is 16 mm; the material of the main body bracket is NiTi wire, the diameter is .016", and the main body bracket includes three bracket segments, from the proximal end to the distal end ( The left side of the figure is the contour bracket section 101, the heightening bracket section 102 and the variable height bracket section 102, wherein the contour bracket section 101 includes 6 waveforms, and the height difference between the peak and the trough is 12 mm, which is high.
  • the bracket segment 102 includes five waveforms, two waveforms at both ends, and the height difference between the peaks and troughs is 12 mm, and the three waveforms in the middle have a height difference of 10 mm between the peaks and the troughs. 6; the main body part of the stent section is stitched in the main body film, the stent section spacing is 4 mm; the body is located at the far and near end of the body has several development points 104, the development point Made of platinum-rhodium alloy, "8"-shaped side branch portion with a height of 3 mm and a width of 1.5 mm
  • the material of the side support film is polyester fiber textile, the length is 15 mm and the diameter is 6 mm; the material of the side support is NiTi wire, diameter is .014", and the side support bracket includes a high height support section 103 (above It is the distal end of the side branch), which consists of 5 waveforms, two waveforms at both ends, the height difference between the peak and the trough is 12 mm, and the three waveforms in the middle have a height difference of 10 mm between the peak and the trough.
  • Figure 6 shows the distance of the stent segment from the main body portion of 3 mm.
  • the heightened stent segment 103 is sutured outside the side branch film, and the center of the side branch is 32 mm from the proximal end of the body. There are several development points 104 on the side branch.
  • Example 1 Bilateral stent graft (see Figures 5 and 6)
  • the material of the main body film is polyester fiber woven fabric, the length is 53 mm, the diameter is 16 mm; the material of the main body bracket is NiTi wire, the diameter is .016", and the main body bracket includes four bracket segments, from the proximal end to the distal end ( The left side of the figure is the proximal end of the main body), which are the contour bracket section 101, the 2 section heightening bracket section 102 and the contour bracket section 101. The unfolded view of these bracket sections is shown in Fig. 6; the main body bracket sections are sutured in the main body cover. Within the membrane, the spacing of the stent segments is 4 mm; there are several development points 104 at the distal and proximal ends of the body.
  • the material of the side support film is polyester fiber textile, the length is 15 mm and the diameter is 6 mm; the material of the side support is NiTi wire, diameter is .014", and the side support bracket includes a high height support section 103 (above The distal end of the lateral branch is shown in Figure 6. The distance between the stent segment and the body portion is 3 mm. The height of the stent segment 103 is sutured outside the lateral branch membrane. 20 mm and 30 mm; there are several development points 104 on the side branches.
  • Example 3 Large-size single-sided stent graft (see Figures 7 and 8)
  • the material of the main body film is a polyester fiber woven fabric having a length of 110 mm and a diameter of 36 mm;
  • the main body bracket comprises 6 bracket segments, the material is NiTi wire, the diameter of the proximal part of the main body segment is .018" (the left side of the main body is the left end), and the other 4 segments have a diameter of .020", from the proximal end to the distal end.
  • the first segment of the contour band 106, the contour band 107, the segment 3 height band 108 and the contour segment 109, the expansion of these stent segments is shown in Figure 9; wherein the first segment of the small band 106 includes 8
  • the height difference between the waveform, the peak and the trough is 12 mm
  • the distance between the middle edges is 10 mm
  • the angle between the lower two edges is 120 degrees.
  • the contour of the small band 107 includes 8 waveforms
  • the height difference between the peak and the trough is 12 mm.
  • the proximal side branch is connected to the main body with a positioning ring 105 made of NiTi wire, and the diameter is 10 mm. Positioned at the proximal end of the body, the position of the positioning ring 105 is as shown in FIG. 9; the bracket segments of the main body are stitched in the main Within the body coating, the spacing of the stent segments is 4 mm; there are several development points 104 at the distal and proximal ends of the body. Side branch
  • the material of the side support film is polyester fiber textile with a length of 30 mm and a diameter of 10 mm; the material of the side support is NiTi wire with a diameter of .014", and the side support includes two high-profile brackets 110 (Fig.
  • the upper side is the distal end of the side branch), which consists of five waveforms, two waveforms at both ends, the height difference between the peak and the trough is 12 mm, and the three waveforms in the middle have a height difference of 10 mm between the peak and the trough, and the side branch
  • the distance between the stent segments is 3 mm, and the distance between the proximal segment of the side branches is 4 mm from the main body portion.
  • the height of the stent segment 110 is sutured outside the lateral branch membrane, and the lateral branches are level with the proximal end of the body; Development point 104.
  • Example 4 Animal test horse
  • Test animals Pig, about 30 kg, half male and half female.
  • the unilateral stent graft of Example 1 was subjected to a total of 32 animal tests, which were applied to the left subclavian artery, 28 of which survived.
  • Figure 9 shows the results of intraoperative angiography. It can be seen that the stent is completely open and the arteries are developed. Clear, collateral and aortic blood flow.
  • Example 2 The bilateral stent graft of Example 2 was tested in 4 animals, which was applied to the innominate artery. And the left subclavian artery, 3 cases survived, Figure 10 is the intraoperative angiography results, the figure shows that the stent is fully open, the arteries are clearly developed, and the collateral and aortic blood flow is smooth.

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

Description

侧支型覆膜支架 本申请要求于 2009 年 3 月 18 日提交中国专利局、 申请号为 200910047748.6、 发明名称为"侧支型覆膜支架"的中国专利申请的优先权， 其全部内容通过引用结合在本申请中。 技术领域
本发明涉及一种用于治疗主动脉疾病的微创介入的医疗器械， 具体地 说， 涉及一种侧支型覆膜支架。 背景技术
近年来， 将覆膜支架用于主动脉疾病治疗是主动脉外科的一大进展， 其适应症包括主动脉夹层动脉瘤、主动脉真性动脉瘤、主动脉假性动脉瘤、 主动脉穿透性溃疡等。 该技术的应用大大降低了常规手术治疗的死亡率以 及术后并发症， 减轻了手术创伤， 患者恢复较快。 以动脉瘤的治疗为例， 其机理是将覆膜支架送入病变部位后张开， 使瘤体与血液隔绝， 从而消除 动脉瘤破裂大出血引起死亡的危险， 或者消除瘤体对周围组织、 器官的压 迫。 目前国内外已有成熟的产品， 例如国外的 Talent、 AneuRex、 Exclude、 Relay和 Gore等, 以及国内的 Hercules、 Aegis和 Ankura等。
但是， 上述产品多为直筒形， 其在近端无侧支协助锚定， 只能采用主 体上的棵段、 小波段和大波段进行定位， 因此需要有足够的锚定距离， 否 则将会产生支架下移和内漏风险， 所以仅适用于胸降主动脉瘤， 通常还要 求瘤体或夹层破口距左锁骨下动脉至少有 15 mm的正常胸主动脉瘤壁。 而 对于夹层或动脉瘤累及左锁骨下动脉的病例则通常多行左锁骨下动脉转移 辅助手术， 然后再应用上述覆膜支架治疗动脉瘤或夹层破裂。 但采取此类 方法仍有较高的内漏并发症， 并且对于夹层或瘤体累及升主动脉瘤至左颈 总动脉范围的患者， 目前尚无可用的覆膜支架， 仍采用常规的手术治疗方 法。
带有侧支的覆膜支架的设计和使用有望使上述患者免除常规的手术治 疗，支架的主体部分和分支部分可分别用于修复主动脉和分支动脉的病变。 CN201131823Y公开了一种带有侧支的动脉腔内支架， 但其主体和侧支支 架段结构单一， 不能适应多变的血管外形； CN101015478A也公开了一种 侧支型覆膜支架， 其侧支部分通过软连接部和主体部分连接， 主体和侧支 部分分别用于主动脉和左锁骨下动脉， 可以同时保证主动脉和左锁骨下动 脉的血供， 但其侧支近端的软连接部， 如果释放不良（例如扭曲或打折时） 将导致左锁骨下动脉闭塞。 因此上述现有技术中的带有侧支的覆膜支架的 应用范围有限， 一般仅可用于左锁骨下动脉的病变， 而对弓部、 升主动脉 或累及多分支的病变无能为力。 发明内容
本发明的目的是提供一种侧支型覆膜支架， 其结构稳定， 弯曲性能良 好， 适合于治疗累及分支动脉的主动脉疾病（例如主动脉瘤）， 其使用状态 如图 1所示。
本发明提供的侧支型覆膜支架， 包括主体部分和侧支部分， 主体部分 和侧支部分均包括支架以及和支架缝合的管状覆膜， 侧支部分的覆膜与主 体部分的覆膜相缝合， 所述主体部分的支架包括多个支架段， 其中至少一 个是变高支架段； 所述侧支部分的支架包括一个或多个支架段， 其中至少 一个是变高支架段， 并且侧支部分最近端的支架段和主体部分之间的距离 为 2-8 mm; 变高支架段是指构成该支架段的柱状单圈展开后， 其波形的所 有波谷都在同一水平线上， 所有波峰并不都在同一水平线上。
优选地， 所述主体部分和 /或侧支部分的变高支架段， 其柱状单圈展开 后的波形如图 2中的一种或多种所示。
优选地， 所述主体部分包括至少一个等高支架段， 所述等高支架段是 指构成该支架段的柱状单圈展开后，其波形的所有波谷都在同一水平线上， 所有波峰也都在同一水平线上。
优选地， 所述主体部分最近端和 /或最远端的支架段是等高支架段。 优选地， 所述侧支部分的数目是 1、 2或 3个。
优选地， 所述侧支部分的支架段缝于膜外。
优选地， 所述主体部分的支架段缝于膜内， 或者所述主体部分近端和 远端的支架段缝于膜内， 中间部分的支架段缝于膜外。
优选地， 所述主体部分的覆膜长度为 40-133 mm, 直径为 16-36 mm, 支架段总数为 3-7个， 支架段间距为 1-5 mm, 所述侧支部分的覆膜长度为 13-30 mm, 直径为 6-14 mm, 支架段总数为 1-2个， 支架段间 巨为 1-5 mm, 所述侧支部分最近端的支架段和所述主体部分之间的距离为 2-4 mm。
优选地， 所述主体部分和所述侧支部分还缝有显影点。
优选地， 连接侧支部分和主体部分的侧孔处使用定位环， 所述定位环 缝制在主体覆膜内、 主体覆膜与侧支覆膜间或侧支覆膜外， 所述定位环的 外形如图 3中的一种所示。
优选地， 所述定位环上有凸缘 100, 所述凸缘 100设置在所述主体部 分的轴向方向。
优选地， 所述支架使用具有良好生物相容性及支撑力的材料， 如形状 记忆合金、 316L 医用不锈钢、 镍基合金（如镍钛丝）、 钴基合金材料或可 降解或不可降解的高分子材料等制成。
优选地，所述覆膜使用具有生物相容性的高分子材料，如聚四氟乙烯、 聚酯纤维纺织物、 聚酰胺纺织物、 聚丙烯纺织物等制成。
优选地， 所述显影点使用铂铱合金、 纯铂、 纯金、 NiTi形状记忆合金 或不锈钢制成。
优选地， 所述定位环使用镍钛丝、 不锈钢丝、 尼龙、 聚氨脂等金属或 非金属材料制成。
本发明所涉及的术语的定义如下：
近端， 指的是覆膜支架靠近心脏的一侧；
远端， 指的是覆膜支架远离心脏的一侧；
波峰， 指的是支架段的单个波形朝向近端最凸起的部分；
波谷， 指的是支架段的单个波形朝向远端最凸起的部分；
侧支部分最近端的支架段和主体部分之间的距离， 是指该支架段朝向 近端最凸起的波峰和主体部分之间的最短距离；
支架段间距， 指的是相邻支架段之间的距离， 具体地说， 是指一支架 段朝向近端最凸起的波峰和与其相邻的近端支架段的所有波谷所在平面间 的最短距离；
侧孔， 指的是侧支部分与主体部分连接处的开口。 本发明的侧支型覆膜支架， 主体部分和侧支部分采用一体式设计， 有 利于降低植入过程中对准、 定位的难度， 而且还能避免两者结合部位内漏 的风险。
主体部分所采用的变高支架段， 有利于主体部分适应主动脉在立体方 向上不同形态的扭曲。
侧支部分所采用的变高支架段以及在侧支部分最近端的支架段和主体 部分之间留有 2-8 mm间隙， 有利于侧支 360° 自由转动， 使侧支部分适应 主动脉侧支在立体方向上不同形态的扭曲， 同时有利于支架充分张开， 避 免在分支血管处血流不畅， 造成血栓， 引起脑部血管供血不足或栓塞的风 险，侧支的设计还有利于增加主体支架的锚定力， 实现动脉瘤的有效封堵。
主体部分最近端和最远端设计一个等高支架段有利于支架良好贴壁， 有效减少发生内漏的风险。
侧支的数量可以根据实际需要设计为 1、 2或 3个，其中单分支可以用 于无名动脉或左锁骨动脉， 双侧支可用于累及无名动脉及左颈总动脉， 或 累及左颈总动脉及左锁骨下动脉的病例，三侧支可用于瘤体累及无名动脉、 左颈总动脉和左锁骨下动脉的病例。
侧支部分的支架段缝于膜外， 有利于最大限度地保留侧支血管的血流 通道， 降低血栓形成的风险。
主体部分的支架段缝于膜内， 有利于提高覆膜的贴壁性能， 降低内漏 的风险， 或者主体部分靠近端及远端的部分缝于膜内， 有利于提高覆膜的 贴壁性能， 降低内漏的风险， 主体支架段靠中间部分的支架段缝于膜外， 有利于降低血栓形成的风险。
主体部分和侧支部分缝有显影点有助于导入过程中精确定位支架主体 和侧支， 避免侧支定位不准导致分支血管导通不良甚至封闭。
侧孔处使用定位环， 有利于加强侧孔张开的能力， 使侧支保持顺畅的 通路， 避免接口处由于血管的扭曲或钙化等不良因素影响， 导致侧支不能 完全张开的风险。
定位环边上如设计有凸缘 100, 则凸缘 100应当设置在支架的轴向方 向上， 以减小支架安装时候的压握直径。 本发明的侧支型覆膜支架可用于升主动脉瘤、 弓部动脉瘤、 降主动脉 瘤及其夹层破裂的治疗。 支架可同时植入主动脉和分支动脉（例如左锁骨 下动脉、 左颈总动脉或无名动脉）， 以治疗累及升主动脉瘤、 主动脉弓以及 降主动脉瘤的夹层破裂及动脉瘤，本发明消除了现有技术中产品的局限性， 基本免除了此类疾病的常规手术治疗， 扩大了应用指证。 附图说明
通过阅读以下参照附图对非限制性实施例所作的详细描述， 本发明的 其它特征、 目的和优点将会变得更明显。
图 1是本发明的侧支型覆膜支架使用状态的示意图；
图 2是优选的变高支架段展开后的示意图；
图 3是定位环的示意图；
图 4是实施例 1的侧支型覆膜支架的示意图；
图 5是实施例 2的侧支型覆膜支架的示意图；
图 6是实施例 1和 2的侧支型覆膜支架的支架段展开后的示意图； 图 7是实施例 3的侧支型覆膜支架的示意图；
图 8是实施例 3的侧支型覆膜支架的支架段展开后的示意图； 图 9是实施例 1的侧支型覆膜支架动物试验的血管造影图；
图 10是实施例 2的侧支型覆膜支架动物试验的血管造影图。 具体实施方式
实施例 1 单侧支覆膜支架（参见图 4和 6 )
主体部分
主体覆膜的材料为聚酯纤维纺织物， 长度为 40 mm, 直径为 16 mm; 主体支架的材料为 NiTi丝， 直径.016" , 主体支架包括三个支架段， 从近 端至远端 （图左为主体近端）依次为等高支架段 101、 变高支架段 102和 变高支架段 102, 其中等高支架段 101 包括 6个波形， 波峰和波谷的高度 差为 12 mm, 变高支架段 102包括 5个波形， 两端的两个波形， 其波峰和 波谷的高度差为 12 mm, 中间的三个波形， 其波峰和波谷的高度差为 10 mm,这些支架段的展开图如图 6所示； 主体部分的支架段均缝合在主体覆 膜内， 支架段间距为 4 mm; 主体上远近端缝有数个显影点 104, 该显影点 由铂铱合金制成， 呈高 3 mm, 宽 1.5 mm的 "8" 字形 侧支部分
侧支覆膜的材料为聚酯纤维纺织物， 长度为 15 mm, 直径为 6 mm; 侧支支架的材料为 NiTi丝，直径.014" ,侧支支架包括一个变高支架段 103 (图上方为侧支远端） ， 其包括 5个波形， 两端的两个波形， 其波峰和波 谷的高度差为 12 mm, 中间的三个波形，其波峰和波谷的高度差为 10 mm, 展开图如图 6所示； 该支架段距主体部分的距离为 3 mm, 变高支架段 103 缝合在侧支覆膜外， 侧支中心距离主体近端 32 mm; 侧支上缝有数个显影 点 104。 实施例 1 双侧支覆膜支架（参见图 5和 6 )
主体部分
主体覆膜的材料为聚酯纤维纺织物， 长度为 53 mm, 直径为 16 mm; 主体支架的材料为 NiTi丝， 直径.016" , 主体支架包括四个支架段， 从近 端至远端（图左为主体近端）依次为等高支架段 101、 2段变高支架段 102 和等高支架段 101 , 这些支架段的展开图如图 6所示； 主体的支架段均缝 合在主体覆膜内，支架段间距为 4 mm;主体上远近端缝有数个显影点 104。 侧支部分
侧支覆膜的材料为聚酯纤维纺织物， 长度为 15 mm, 直径为 6 mm; 侧支支架的材料为 NiTi丝，直径.014" ,侧支支架包括一个变高支架段 103 (图上方为侧支远端） ， 其展开图如图 6所示； 支架段距主体部分的距离 为 3 mm, 变高支架段 103缝合在侧支覆膜外， 两侧支中心距离主体近端分 别为 20 mm和 30 mm; 侧支上缝有数个显影点 104。 实施例 3 大规格单侧支覆膜支架（参见图 7和 8 )
主体部分
主体覆膜的材料为聚酯纤维纺织物， 长度为 110 mm, 直径为 36 mm; 主体支架包括 6个支架段，材料为 NiTi丝，主体段近端两段的直径为.018" (图左为主体近端） ， 其余 4段的直径为.020" , 从近端至远端依次为首 段等高小波段 106、等高小波段 107、 3段变高大波段 108和等高尾段 109, 这些支架段的展开图如图 9所示；其中首段等高小波段 106包括 8个波形， 波峰和波谷的高度差为 12 mm, 中间两棱间距 10 mm, 下面两棱夹角 120 度； 等高小波段 107包括 8个波形， 波峰和波谷的高度差为 12 mm; 变高 大波段 108包括 5个波形， 两端的两个波形， 其波峰和波谷的高度差为 19 mm, 第 2个和第 4个波形， 其波峰和波谷的高度差为 17 mm, 第 3个波 形， 其波峰和波谷的高度差为 15 mm; 等高尾段 109包括 5个波形， 波峰 和波谷的高度差为 19 mm;近端侧支与主体连接处有 NiTi丝制成的定位环 105 , 直径 10 mm, 与主体近端相平， 定位环 105的位置如图 9所示； 主体 的支架段均缝合在主体覆膜内， 支架段间距为 4 mm;主体上远近端缝有数 个显影点 104。 侧支部分
侧支覆膜的材料为聚酯纤维纺织物， 长度为 30 mm, 直径为 10 mm; 侧支支架的材料为 NiTi丝，直径.014" ,侧支支架包括 2个变高支架段 110 (图上方为侧支远端） ， 其包括 5个波形， 两端的两个波形， 其波峰和波 谷的高度差为 12 mm, 中间的三个波形，其波峰和波谷的高度差为 10 mm, 侧支支架段间距为 3 mm,侧支最近端的支架段距主体部分的距离为 4 mm, 变高支架段 110缝合在侧支覆膜外， 侧支与主体近端相平； 侧支上缝有数 个显影点 104。 实施例 4 动物试马全
试验动物： 猪， 30公斤左右， 雌雄各半。
实施例 1的单侧支覆膜支架共进行动物试验 32例，其应用于左锁骨下 动脉， 其中存活 28例， 图 9是术中造影结果， 由图可知支架张开完全， 各 动脉血管显影清晰， 侧支及主动脉血流通畅。
实施例 2的双侧支覆膜支架共进行动物试验 4例， 其应用于无名动脉 和左锁骨下动脉， 存活 3例， 图 10是术中造影结果， 由图可知支架张开完 全， 各动脉血管显影清晰， 侧支及主动脉血流通畅。

Claims

权 利 要 求
1. 一种侧支型覆膜支架， 包括主体部分和侧支部分， 主体部分和侧支 部分均包括支架以及和支架缝合的管状覆膜， 侧支部分的覆膜与主体部分 的覆膜相缝合， 其特征在于： 主体部分的支架包括多个支架段， 其中至少 一个是变高支架段； 侧支部分的支架包括一个或多个支架段， 其中至少一 个是变高支架段， 并且侧支部分最近端的支架段和主体部分之间的距离为 2-8 mm; 变高支架段是指构成该支架段的柱状单圈展开后， 其波形的所有 波谷都在同一水平线上， 所有波峰并不都在同一水平线上。
2. 如权利要求 1所述的侧支型覆膜支架， 其特征在于， 所述主体部分 和 /或侧支部分的变高支架段，其柱状单圈展开后的波形如图 2中的一种或 多种所示。
3. 如权利要求 2所述的侧支型覆膜支架， 其特征在于， 所述主体部分 包括至少一个等高支架段， 所述等高支架段是指构成该支架段的柱状单圈 展开后， 其波形的所有波谷都在同一水平线上， 所有波峰也都在同一水平 线上。
4. 如权利要求 3所述的侧支型覆膜支架 , 其特征在于, 所述主体部 最近端和 /或最远端的支架段是等高支架段。
5. 如权利要求 4所述的侧支型覆膜支架 , 其特征在于, 所述侧支部 的数目是 1、 2或 3个。
6. 如权利要求 5所述的侧支型覆膜支架 , 其特征在于, 所述侧支部 的支架段缝于膜外， 所述主体部分的支架段缝于膜内或者所述主体部分近 端和远端的支架段缝于膜内， 中间部分的支架段缝于膜外。
7. 如权利要求 6所述的侧支型覆膜支架， 其特征在于， 所述主体部分 的覆膜长度为 40-133 mm, 直径为 16-36 mm, 支架段的数目为 3-7个， 支 架段间距为 1-5 mm, 所述侧支部分的覆膜长度为 13-30 mm, 直径为 6-14 mm, 支架段的数目为 1-2个， 支架段间距为 1-5 mm, 所述侧支部分最近 端的支架段和所述主体部分之间的距离为 2-4 mm。
8. 如权利要求 7所述的侧支型覆膜支架， 其特征在于， 所述主体部分 和所述侧支部分还缝有显影点。
9. 如权利要求 8所述的侧支型覆膜支架， 其特征在于， 所述支架使用 形状记忆合金、 316L医用不锈钢、 镍基合金或钴基合金材料制成， 所述覆 膜使用聚四氟乙烯、聚酯纤维纺织物、聚酰胺纺织物或聚丙烯纺织物制成， 所述显影点使用铂铱合金、 纯铂、 纯金、 NiTi形状记忆合金或不锈钢制成。
10. 如权利要求 1-9任何一项所述的侧支型覆膜支架， 其特征在于， 连接侧支部分和主体部分的侧孔处使用定位环， 所述定位环缝制在主体覆 膜内、 主体覆膜与侧支覆膜间或侧支覆膜外， 所述定位环的外形如图 3中 的一种所示。
11. 如权利要求 10所述的侧支型覆膜支架， 其特征在于， 所述定位环 上有凸缘， 所述凸缘设置在所述主体部分的轴向方向。
12. 如权利要求 11所述的侧支型覆膜支架， 其特征在于， 所述定位环 使用镍钛丝、 不锈钢丝、 尼龙或聚氨脂制成。
PCT/CN2010/071099 2009-03-18 2010-03-17 侧支型覆膜支架 WO2010105561A1 (zh)

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