CN108670511A - A kind of flexible short holder of screw type - Google Patents
A kind of flexible short holder of screw type Download PDFInfo
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- CN108670511A CN108670511A CN201810566142.2A CN201810566142A CN108670511A CN 108670511 A CN108670511 A CN 108670511A CN 201810566142 A CN201810566142 A CN 201810566142A CN 108670511 A CN108670511 A CN 108670511A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
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Abstract
Description
技术领域technical field
本发明涉及植入式假体医疗器械技术领域,具体是一种螺旋型柔性短支架。The invention relates to the technical field of implantable prosthesis medical devices, in particular to a helical flexible short stent.
背景技术Background technique
人体管腔狭窄,堵塞和再狭窄,管腔瘤变等是常见且危险的病变;临床上此类病变可发生在任何生理管腔中,包括心脑血管,内分泌泌尿生殖系统,消化和呼吸系统腔道中。鉴于球囊扩张术疗效短,管腔支架术是治疗此种病变的重要的,甚至是主要的治疗手段。Human lumen stenosis, blockage and restenosis, luminal neoplasia, etc. are common and dangerous lesions; clinically, such lesions can occur in any physiological lumen, including cardiovascular and cerebrovascular, endocrine, genitourinary, digestive and respiratory systems In the cavity. In view of the short curative effect of balloon dilatation, luminal stenting is an important and even the main treatment for this kind of lesion.
鉴于释放膨胀方式的差异,管腔支架可以分为自膨胀式支架和球囊扩张式支架。考虑到释放后,在复杂生理环境中易发生坍塌的现象,一般球阔式支架只是应用在生物力学环境比较温和的冠脉中。而使用简单,径向支撑力优良的自膨胀式支架应用广泛,也是本专利所关注的焦点。In view of the difference in release and expansion methods, endoluminal stents can be divided into self-expandable stents and balloon-expandable stents. Considering that after release, it is prone to collapse in a complex physiological environment, generally the broad-spherical stent is only used in coronary arteries where the biomechanical environment is relatively mild. The self-expanding stent that is easy to use and has excellent radial support is widely used, and is also the focus of this patent.
目前,自膨胀支架一般由形状记忆金属管激光切割并后处理制成。这类支架通常径向支持良好,输送定位精确,压缩和扩张便宜。尽管自膨胀支架具有成熟的研发和悠久的临床使用历史,但目前其结构和性能仍然存在着很多缺陷。At present, self-expanding stents are generally made by laser cutting and post-processing of shape memory metal tubes. These stents are usually well radially supported, precisely positioned for delivery, and inexpensive to compress and expand. Although self-expanding stents have mature research and development and a long history of clinical use, there are still many defects in their structure and performance.
本发明提供一种针对支架的结构设计,使其在兼具良好的柔顺性、充足的径向强度及轴向强度的同时;显影清晰,定位准确;压握方便,多个短支架同时使用替代长支架,进一步提高柔顺性。此外这类支架还能够提供载药能力,使手术更加精确,便易。The invention provides a structural design for the bracket, which has good flexibility, sufficient radial strength and axial strength; clear development, accurate positioning; convenient pressing and holding, multiple short brackets can be used at the same time to replace Long brace for further flexibility. In addition, this type of stent can also provide drug-loading ability, making the operation more precise and convenient.
发明内容Contents of the invention
本发明致力于提供一种具有显影清晰,定位精确;压握释放便宜;柔顺性好,径向强度高;且多个短支架同时使用可替代一根长支架使用。The present invention aims to provide a device with clear development, precise positioning, cheap grip and release, good flexibility and high radial strength, and multiple short supports can replace one long support when used at the same time.
本发明的目的是通过以下技术方案实现的:一种螺旋型柔性短支架,包括支架本体区和显影定位区。The object of the present invention is achieved through the following technical solutions: a helical flexible short stent, comprising a stent body area and a developing positioning area.
支架本体区由位于端部的第五波形物绕线和第六波形物绕线、位于所述两个端部之间的第一波形物绕线,第一波形物绕线与端部之间通过过渡区实现连接,所述过渡区包括第二波形物绕线,第三波形物绕线,第四波形物绕线。其中,第五波形物绕线通过第二波形物绕线与第一波形物绕线连接,第六波形物绕线依次通过第四波形物绕线和第三波形物绕线与第一波形物绕线连接。各波形物绕线间形成连贯整体。The stent body area is composed of the fifth wave winding and the sixth wave winding at the end, the first wave winding between the two ends, and the first wave winding and the end The connection is made through a transition zone comprising a second undulation, a third undulation, and a fourth undulation. Wherein, the fifth wave-shaped winding is connected to the first wave-shaped winding through the second wave-shaped winding, and the sixth wave-shaped winding is connected to the first wave-shaped winding through the fourth wave-shaped winding and the third wave-shaped winding in sequence. Wired connection. A coherent whole is formed between the windings of the corrugated objects.
显影定位区由一个显影环和一个定位桥,组成;显影环中含有一个焊接显影金属的显影点。The development positioning area is composed of a development ring and a positioning bridge; the development ring contains a development point for welding the development metal.
第一波形物绕线由多个第一波形物依次连接形成螺旋结构,第一波形物由两个第一圆弧单元和两根第一筋条组成;其中一个第一圆弧单元构成第一波形物的波峰,另一个构成第一波形物的波谷;所述第一波形物绕线中的所有第一波形物沿螺旋结构轴向呈现波峰对波谷方式排列;第一筋条长度保持一致;The winding of the first undulating object is sequentially connected by a plurality of first undulating objects to form a helical structure. The first undulating object is composed of two first arc units and two first ribs; one of the first arc units constitutes the first The crests of the undulations and the other form the troughs of the first undulations; all the first undulations in the winding of the first undulations are arranged in a crest-to-valley manner along the axial direction of the helical structure; the length of the first ribs remains the same;
第五波形物绕线由多个第五波形物依次连接,第六波形物绕线由多个第六波形物依次连接,第五波形物绕线和第六波形物绕线连接形成环形结构,每个第五波形物由两个第五筋条和两个第五圆弧单元组成,其中一个第五圆弧单元构成第五波形物的波峰,另一个构成第五波形物的波谷;第五筋条长度保持一致;每个第六波形物由两个第六筋条和两个第六圆弧单元组成,其中一个第六圆弧单元构成第六波形物的波峰,另一个第六波形物的波谷;第六筋条长度保持一致。The fifth undulating object winding is sequentially connected by a plurality of fifth undulating objects, the sixth undulating object winding is sequentially connected by a plurality of sixth undulating objects, the fifth undulating object winding and the sixth undulating object are connected to form a ring structure, Each fifth undulation is made up of two fifth ribs and two fifth arc units, wherein one fifth arc unit forms the crest of the fifth undulation, and the other forms the trough of the fifth undulation; the fifth The length of the ribs remains the same; each sixth rib is composed of two sixth ribs and two sixth arc units, one of the sixth arc units constitutes the crest of the sixth wave, and the other sixth The trough; the length of the sixth rib remains the same.
过渡区为一直角梯形区域,第二波形物绕线位于该直角梯形区域的上部;第二波形物绕线由多个第二波形物依次连接而成,每个第二波形物由两个第二筋条和两个第二圆弧单元组成,其中一个第二圆弧单元构成第二波形物的波峰,另一个构成第二波形物的波谷;第二筋条自上到下长度分别呈倍数递增;The transition zone is a right-angled trapezoidal area, and the second undulating object winding is located on the upper part of the right-angled trapezoidal area; the second undulating object winding is formed by sequentially connecting a plurality of second undulating objects, and each second undulating object is composed of two second undulating objects Composed of two ribs and two second arc units, one of the second arc units constitutes the crest of the second corrugated object, and the other constitutes the trough of the second corrugated object; the lengths of the second ribs are multiples from top to bottom increment;
第三波形物绕线和第四波形物绕线位于该梯形区域的下部,第三波形物绕线由多个第三波形物依次连接而成,第三波形物由两个第三筋条和两个第三圆弧单元连接而成;第四波形物绕线由多个第四波形物依次连接而成,第四波形物由两个第四筋条和两个第四圆弧单元连接而成,且所述第三筋条、第四筋条从上到下分别呈倍数递增;The third wave-shaped object winding and the fourth wave-shaped object winding are located at the lower part of the trapezoidal area, the third wave-shaped object winding is formed by connecting a plurality of third wave objects in sequence, and the third wave object is composed of two third ribs and Two third arc units are connected; the fourth corrugated object winding is formed by connecting multiple fourth corrugated objects in sequence, and the fourth corrugated object is formed by connecting two fourth ribs and two fourth arc units. , and the third rib and the fourth rib increase in multiples from top to bottom;
所述第四波形物绕线始端与第二波形物绕线尾端相连,所述第三波形物绕线的始端通过B型第三连接桥与第二波形物绕线最下方的第二筋条相连;The beginning end of the fourth wave winding is connected to the tail end of the second wave winding, and the beginning end of the third wave winding is connected to the bottom second rib of the second wave winding through the B-type third connecting bridge strip connected;
第二波形物绕线,第三波形物绕线,第四波形物绕线共同构成一环形结构,其中,第二波形物绕线的始端与第四波形物绕线的末端相连,第三波形物绕线的末端与第一波形物绕线的端部相连。The second wave object winding, the third wave object winding, and the fourth wave object winding together form a ring structure, wherein, the beginning end of the second wave object winding is connected to the end of the fourth wave object winding, and the third wave object winding The end of the object winding is connected to the end of the first wave object winding.
第一波形物绕线的各个相邻的螺旋周期之间具有若干第一连接桥;第一连接桥的两端连接位于不同螺旋周期上的第一圆弧单元;There are several first connecting bridges between each adjacent helical period of the first wave winding; the two ends of the first connecting bridge are connected to the first arc units located on different helical periods;
第一波形物绕线与第二波形物绕线之间具有多个第二连接桥;第二连接桥连接第一圆弧单元与第二圆弧单元。且其中一个第二连接桥连接于第二波形物绕线最下方的第二圆弧单元;There are a plurality of second connecting bridges between the first wave winding and the second wave winding; the second connecting bridges connect the first arc unit and the second arc unit. And one of the second connecting bridges is connected to the second arc unit at the bottom of the second wave winding;
第一波形物绕线与第三波形物绕线之间具有A型第三连接桥,A型第三连接桥连接第一圆弧单元与第三圆弧单元。There is an A-shaped third connecting bridge between the first wave winding and the third wave winding, and the A-shaped third connecting bridge connects the first arc unit and the third arc unit.
第三波形物绕线与第四波形物绕线之间具有第四连接桥,第四连接桥连接第三圆弧单元与第四圆弧单元。There is a fourth connecting bridge between the third wave-shaped object winding and the fourth wave-shaped object winding, and the fourth connecting bridge connects the third arc unit and the fourth arc unit.
第二波形物与第五波形物由多个沿轴向布置的第五连接桥连接,具体连接位置为两个相对的第二圆弧单元与第五圆弧单元之间。The second undulation and the fifth undulation are connected by a plurality of fifth connecting bridges arranged in the axial direction, and the specific connection position is between two opposite second arc units and the fifth arc unit.
第四波形物与第六波形物由多个沿轴向布置的第六连接桥连接,具体连接位置为两个相对的第四圆弧单元与第六圆弧单元之间。The fourth undulation and the sixth undulation are connected by a plurality of sixth connecting bridges arranged in the axial direction, and the specific connection position is between two opposite fourth arc units and sixth arc units.
进一步地,第一波形物绕线包含3~4个螺旋周期。第一波形物绕线的每个螺旋周期包含16个第一波形物;第二波形物绕线包含9个第二波形物;第三波形物绕线包含6个第三波形物;第四波形物绕线包含7个第四波形物;第五波形物绕线包含8个第五波形物;第六波形物绕线包含8个第六波形物。Further, the first wave winding includes 3-4 helical periods. Each helical period of the first undulation winding contains 16 first undulations; the second undulation winding contains 9 second undulations; the third undulation winding contains 6 third undulations; the fourth undulation The object winding includes 7 fourth undulations; the fifth undulation winding includes 8 fifth undulations; the sixth undulation winding includes 8 sixth undulations.
进一步地,第一波形物绕线螺旋角为70度;第二波形物绕线螺旋角度为78°-82°;第三波形物绕线螺旋角度为70°-75°;第四波形物绕线螺旋角度为75°-85°。Further, the first wave object winding helix angle is 70 degrees; the second wave object winding helix angle is 78°-82°; the third wave object winding helix angle is 70°-75°; the fourth wave object winding The wire helix angle is 75°-85°.
进一步地,所述B型第三连接桥的连接于第二波形物绕线的第二筋条的长度的32%-40%处,偏向第一波形物一侧。Further, the B-type third connecting bridge is connected to the second rib of the second wave winding at 32%-40% of the length, and is biased to the first wave side.
进一步地,第一连接桥、第二连接桥、第三连接桥、第四连接桥倾斜方向相同。第一连接桥,A型第三连接桥的倾斜角度范围:68°-72°;B型第三连接桥倾斜角度为66°-70°;连接于第二波形物绕线最下方的第二圆弧单元的第二连接桥倾斜角度范围为68°-72°,其余的第二连接桥倾斜角度为55°-72°;第四连接桥倾斜角度为32°-35°。Further, the inclination directions of the first connecting bridge, the second connecting bridge, the third connecting bridge and the fourth connecting bridge are the same. The inclination angle range of the first connection bridge and the A-type third connection bridge: 68°-72°; the inclination angle of the B-type third connection bridge is 66°-70°; The inclination angle of the second connecting bridge of the arc unit is 68°-72°, the inclination angle of the remaining second connecting bridges is 55°-72°; the inclination angle of the fourth connecting bridge is 32°-35°.
进一步地,任意一个连接有第一连接桥的第一圆弧单元的两侧具有3-4个未连接第一连接桥的第一圆弧单元;任意一个连接有第二连接桥的第二圆弧单元两侧具有3-4个未连接第二连接桥的第二圆弧单元;任意一个连接有A型第三连接桥的第三圆弧单元两侧具有3-4个未连接任意连接桥的第三圆弧单元。任意一个连接有第四连接桥的圆弧单元两侧具有3-4个未连接任意连接桥的圆弧单元。Further, there are 3-4 first circular arc units not connected to the first connecting bridge on both sides of any first circular arc unit connected to the first connecting bridge; any second circular arc unit connected to the second connecting bridge There are 3-4 second circular arc units not connected to the second connecting bridge on both sides of the arc unit; any third circular arc unit connected to the A-type third connecting bridge has 3-4 unconnected arbitrary connecting bridges on both sides The third arc unit of . There are 3-4 arc units not connected to any connecting bridge on both sides of any arc unit connected with the fourth connecting bridge.
进一步地,第一筋条长度保持一致;第二筋条长度从上而下呈公比为1-1.1的等比数列递增;第三筋条长度从上而下呈公比为1-1.15的等比数列递增;第四筋条长度从上而下呈公比为1-1.2的等比数列递增;第五筋条和第六筋条长度保持一致。且第五筋条和第六筋条的长度不相等。任一第二筋条的长度均长于第一筋条、第三筋条和第四筋条;第二筋条的宽度宽于其他筋条的宽度。Further, the length of the first ribs remains consistent; the length of the second ribs increases from top to bottom in a geometric sequence with a common ratio of 1-1.1; the length of the third ribs in a common ratio of 1-1.15 from top to bottom The geometric sequence increases; the length of the fourth rib increases from top to bottom in a geometric sequence with a common ratio of 1-1.2; the fifth rib and the sixth rib keep the same length. And the lengths of the fifth rib and the sixth rib are not equal. The length of any second rib is longer than that of the first rib, the third rib and the fourth rib; the width of the second rib is wider than that of other ribs.
进一步地,第一连接桥长度一致;第五连接桥长度从上而下呈公比为1-1.2的等比数列递增;第六连接桥长度从上而下呈公比为1-1.1的等比数列递增。且最短的第五连接桥长度大于第五筋条长度的1/4。Further, the length of the first connecting bridge is the same; the length of the fifth connecting bridge increases from top to bottom in a geometric sequence with a common ratio of 1-1.2; the length of the sixth connecting bridge is in a common ratio of 1-1.1 from top to bottom. Incremental than the sequence. And the length of the shortest fifth connecting bridge is greater than 1/4 of the length of the fifth rib.
进一步地,所述第一连接桥的两个连接端之间竖直跨度间隔一个第一连接圆弧。同理,所述第二连接桥,第三连接桥和第四连接桥的两个连接端之间竖直跨度间隔一个连接圆弧。Further, the vertical span between the two connection ends of the first connection bridge is separated by a first connection arc. Similarly, the vertical spans between the two connecting ends of the second connecting bridge, the third connecting bridge and the fourth connecting bridge are separated by a connecting arc.
进一步地,定位桥的长度为第六筋条长度的0.5-1倍。显影点的横截最大宽度为第六筋条宽度的6-7倍。Further, the length of the positioning bridge is 0.5-1 times the length of the sixth rib. The maximum cross-sectional width of the developing point is 6-7 times of the width of the sixth rib.
本发明的技术优点在于:Technical advantage of the present invention is:
1,支架显影区大于普通支架显影区域面积,显影清晰,定位精确;1. The development area of the stent is larger than that of the ordinary stent, with clear development and precise positioning;
2,支架结构均匀,长度较短,压握释放便宜;2. The structure of the bracket is uniform, the length is short, and the pressure and release are cheap;
3,支架本体中央开环设计,波形物波峰对波谷排列,弯曲性好,柔顺性强;3. The central open-loop design of the bracket body, the crests of the wave objects are arranged against the troughs, with good bendability and strong flexibility;
4,支架本体两端闭环设计,波峰对波峰排列,定位性好;4. The closed-loop design at both ends of the bracket body, the wave peaks are arranged on the wave peaks, and the positioning is good;
5,支架本体远端具有两种类型的筋条,长度不一致,便于支架定位;5. There are two types of ribs at the far end of the stent body, with inconsistent lengths, which facilitates the positioning of the stent;
6,支架较普通支架短,多个串联使用,减少金属与人体接触面积,最大程度的降低了支架弯曲产生的断裂,使用效果更佳。6. The bracket is shorter than ordinary brackets, and multiple series are used to reduce the contact area between metal and human body, minimize the fracture caused by bracket bending, and use better.
附图说明Description of drawings
图1为本发明实施例的结构示意图;Fig. 1 is the structural representation of the embodiment of the present invention;
图2为本发明实施例的局部结构示意图;Fig. 2 is the partial structure schematic diagram of the embodiment of the present invention;
图3为支架本体区扩展后的示意图;Fig. 3 is a schematic diagram of the expanded body region of the stent;
图4为波形物的示意图;Fig. 4 is the schematic diagram of corrugated object;
图5为显影定位区扩展后的示意图;Fig. 5 is a schematic diagram after the development positioning area is expanded;
图中,1-支架本体区,11-第一波形物绕线,111-第一波形物,111a–第一筋条,111b-第一圆弧单元,12-第二波形物绕线,121-第二波形物,121a–第二筋条,121b-第二圆弧单元,13-第三波形物绕线,131-第三波形物,131a–第三筋条,131b-第三圆弧单元,14-第四波形物绕线,141-第四波形物,141a–第四筋条,141b-第四圆弧单元,15-第五波形物绕线,151-第五波形物,151a–第五筋条,151b-第五圆弧单元,16-第六波形物绕线,161-第六波形物,161a–第六筋条,161b-第六圆弧单元;01-第一连接桥,02a-A型第二连接桥,02b-B型第二连接桥,03a-A型第三连接桥,03b-B型第三连接桥,04-第四连接桥,05-第五连接桥,06-第六连接桥;2-显影定位区,21-显影环,211-显影点,22-定位桥。In the figure, 1-stent body area, 11-the first corrugated object winding, 111-the first corrugated object, 111a-the first rib, 111b-the first arc unit, 12-the second corrugated object winding, 121 - second wave, 121a - second rib, 121b - second arc unit, 13 - third wave winding, 131 - third wave, 131a - third rib, 131b - third arc Unit, 14-the fourth wave winding, 141-the fourth wave, 141a-the fourth rib, 141b-the fourth arc unit, 15-the fifth wave winding, 151-the fifth wave, 151a – the fifth rib, 151b- the fifth arc unit, 16- the sixth wave winding, 161- the sixth wave, 161a- the sixth rib, 161b- the sixth arc unit; 01- the first connection Bridge, 02a-type A second connection bridge, 02b-B type second connection bridge, 03a-A type third connection bridge, 03b-B type third connection bridge, 04-fourth connection bridge, 05-fifth connection bridge Bridge, 06-sixth connecting bridge; 2-developing positioning area, 21-developing ring, 211-developing point, 22-locating bridge.
具体实施方式Detailed ways
本发明公开了一种创新性螺旋型柔性短支架,可由压缩时的第一外径自行膨胀扩张至匹配病变腔体的第二外径,可用于扩张任何堵塞或狭窄的管道而治疗管腔狭窄、再狭窄,管腔瘤变或管壁夹层等疾病。The invention discloses an innovative helical flexible short stent, which can self-expand and expand from the first outer diameter when compressed to the second outer diameter matching the lesion cavity, and can be used to expand any blocked or narrowed pipeline to treat lumen stenosis , restenosis, luminal neoplasia or wall dissection and other diseases.
如图1所示,一种螺旋型柔性短支架由支架本体区1和显影定位区2组成;As shown in Figure 1, a helical flexible short stent consists of a stent body area 1 and a development positioning area 2;
如图2所示,支架本体区1由位于端部的第五波形物绕线15和第六波形物绕线16、位于所述两个端部之间的第一波形物绕线11,第一波形物绕线11与端部之间通过过渡区实现连接,所述过渡区包括第二波形物绕线12,第三波形物绕线13,第四波形物绕线14。其中,第五波形物绕线15通过第二波形物绕线12与第一波形物绕线11连接,第六波形物绕线16依次通过第四波形物绕线14和第三波形物绕线13与第一波形物绕线11连接。各波形物绕线间形成连贯整体。As shown in FIG. 2 , the stent body region 1 is composed of a fifth wave winding 15 and a sixth wave winding 16 located at the ends, a first wave winding 11 located between the two ends, and a sixth wave winding 11 located between the two ends. A wave-shaped winding 11 is connected to the end through a transition area, and the transition area includes a second wave-shaped winding 12 , a third wave-shaped winding 13 , and a fourth wave-shaped winding 14 . Among them, the fifth wave winding 15 is connected to the first wave winding 11 through the second wave winding 12, and the sixth wave winding 16 is sequentially passed through the fourth wave winding 14 and the third wave winding. 13 is connected to the first wave winding 11. A coherent whole is formed between the windings of the corrugated objects.
显影定位区2由一个显影环21和一个定位桥22,组成;显影环21中含有一个焊接显影金属的显影点211。The developing positioning area 2 is composed of a developing ring 21 and a positioning bridge 22; the developing ring 21 contains a developing point 211 where the developing metal is welded.
第一波形物绕线11由多个第一波形物111依次连接形成螺旋结构,第一波形物111由两个第一圆弧单元111b和两根第一筋条111a组成;其中一个第一圆弧单元111b构成第一波形物111的波峰,另一个构成第一波形物111的波谷;所述第一波形物绕线11中的所有第一波形物111沿螺旋结构轴向呈现波峰对波谷方式排列;支架释放膨胀后,上一圈波峰刚好落在下一圈波谷里,最大程度上提高了了中央主体区的柔顺性和顺应性。第一筋条111a长度保持一致;The first corrugated object winding 11 is sequentially connected by a plurality of first corrugated objects 111 to form a helical structure, and the first undulated object 111 is composed of two first circular arc units 111b and two first ribs 111a; The arc unit 111b constitutes the crest of the first wave object 111, and the other constitutes the valley of the first wave object 111; all the first wave objects 111 in the first wave object winding 11 present a peak-to-valley manner along the axial direction of the helical structure Arrangement; after the stent is released and expanded, the peaks of the previous circle just fall into the troughs of the next circle, which improves the flexibility and compliance of the central main body area to the greatest extent. The length of the first rib 111a is consistent;
第五波形物绕线15由多个第五波形物151依次连接,第六波形物绕线16由多个第六波形物161依次连接,第五波形物绕线15和第六波形物绕线16连接形成环形结构,每个第五波形物151由两个第五筋条151a和两个第五圆弧单元151b组成,其中一个第五圆弧单元151b构成第五波形物151的波峰,另一个构成第五波形物151的波谷;第五筋条151a长度保持一致;每个第六波形物161由两个第六筋条161a和两个第六圆弧单元161b组成,其中一个第六圆弧单元161b构成第六波形物161的波峰,另一个第六波形物161的波谷;第六筋条161a长度保持一致。The fifth undulating wire 15 is sequentially connected by a plurality of fifth undulating wires 151, the sixth undulating wire 16 is sequentially connected by a plurality of sixth undulating wires 161, the fifth undulating wire 15 and the sixth undulating wire 16 are connected to form a ring structure, and each fifth rib 151 is composed of two fifth ribs 151a and two fifth arc units 151b, wherein one fifth arc unit 151b constitutes the crest of the fifth rib 151, and the other A trough that constitutes the fifth wave 151; the length of the fifth rib 151a is consistent; each sixth wave 161 is composed of two sixth ribs 161a and two sixth arc units 161b, one of the sixth circles The arc unit 161b constitutes the crest of the sixth wave 161 and the valley of the other sixth wave 161; the length of the sixth rib 161a is consistent.
过渡区为一直角梯形区域,第二波形物绕线12位于该直角梯形区域的上部;第二波形物绕线12由多个第二波形物121依次连接而成,每个第二波形物121由两个第二筋条121a和两个第二圆弧单元121b组成,其中一个第二圆弧单元121b构成第二波形物121的波峰,另一个构成第二波形物121的波谷;第二筋条121a自上到下长度分别呈倍数递增;The transition zone is a right-angled trapezoidal area, and the second wave-shaped object winding 12 is located on the upper part of the right-angled trapezoidal area; the second wave-shaped object winding 12 is formed by sequentially connecting a plurality of second wave-shaped objects 121, and each second wave-shaped object 121 It consists of two second ribs 121a and two second arc units 121b, wherein one second arc unit 121b constitutes the crest of the second corrugated object 121, and the other constitutes the trough of the second corrugated object 121; the second rib The lengths of the bars 121a increase in multiples from top to bottom;
第三波形物绕线13和第四波形物绕线14位于该梯形区域的下部,第三波形物绕线13由多个第三波形物131依次连接而成,第三波形物131由两个第三筋条131a和两个第三圆弧单元131b连接而成;第四波形物绕线14由多个第四波形物141依次连接而成,第四波形物141由两个第四筋条141a和两个第四圆弧单元141b连接而成,且所述第三筋条312、第四筋条322从上到下分别呈倍数递增;The third undulating wire 13 and the fourth undulating wire 14 are located at the lower part of the trapezoidal area, the third undulating wire 13 is formed by connecting successively a plurality of third undulating objects 131, and the third undulating object 131 is composed of two The third rib 131a is connected with two third arc units 131b; the fourth corrugated winding 14 is formed by sequentially connecting a plurality of fourth corrugated objects 141, and the fourth corrugated object 141 is composed of two fourth ribs 141a and two fourth arc units 141b are connected, and the third rib 312 and the fourth rib 322 respectively increase in multiples from top to bottom;
所述第四波形物绕线14始端与第二波形物绕线12尾端相连,所述第三波形物绕线13的始端通过B型第三连接桥03b与第二波形物绕线12最下方的第二筋条121a相连;The beginning end of the fourth wave winding 14 is connected to the tail end of the second wave winding 12, and the beginning end of the third wave winding 13 is connected to the end of the second wave winding 12 through the B-type third connecting bridge 03b. The second ribs 121a below are connected;
第二波形物绕线12,第三波形物绕线13,第四波形物绕线14共同构成一环形结构,其中,第二波形物绕线12的始端与第四波形物绕线14的末端相连,第三波形物绕线13的末端与第一波形物绕线11的端部相连。这种过渡便于力的均匀传递和分布,以便于支架的压握和释放。The second wave winding 12, the third wave winding 13, and the fourth wave winding 14 together form a ring structure, wherein the beginning of the second wave winding 12 and the end of the fourth wave winding 14 The end of the third wave winding 13 is connected to the end of the first wave winding 11 . This transition facilitates even force transfer and distribution for crimping and releasing of the stent.
第一波形物绕线11的各个相邻的螺旋周期之间具有若干第一连接桥01;第一连接桥01的两端连接位于不同螺旋周期上的第一圆弧单元111b;There are several first connecting bridges 01 between each adjacent helical period of the first wave winding 11; the two ends of the first connecting bridge 01 are connected to the first arc units 111b located on different helical periods;
第一波形物绕线11与第二波形物绕线12之间具有多个第二连接桥02;第二连接桥02连接第一圆弧单元111b与第二圆弧单元121b。且其中一个第二连接桥02连接于第二波形物绕线12最下方的第二圆弧单元121b;There are a plurality of second connecting bridges 02 between the first wave winding 11 and the second wave winding 12; the second connecting bridges 02 connect the first arc unit 111b and the second arc unit 121b. And one of the second connecting bridges 02 is connected to the second arc unit 121b at the bottom of the second wave winding 12;
第一波形物绕线11与第三波形物绕线13之间具有A型第三连接桥03a,A型第三连接桥03a连接第一圆弧单元111b与第三圆弧单元131b。There is an A-shaped third connecting bridge 03 a between the first wave winding 11 and the third wave winding 13 , and the A-shaped third connecting bridge 03 a connects the first arc unit 111 b and the third arc unit 131 b.
第三波形物绕线13与第四波形物绕线14之间具有第四连接桥04,第四连接桥04连接第三圆弧单元131b与第四圆弧单元141b。There is a fourth connecting bridge 04 between the third wave winding 13 and the fourth wave winding 14, and the fourth connecting bridge 04 connects the third arc unit 131b and the fourth arc unit 141b.
第二波形物121与第五波形物151由多个沿轴向布置的第五连接桥05连接,具体连接位置为两个相对的第二圆弧单元121b与第五圆弧单元151b之间。即第二波形物121与第五波形物151之间,及第四波形物141与第六波形物161之间均呈波峰对波峰排列;波峰对波峰的设计使得支架本体区两端具有良好的径向支撑力,同时确保了优良的力的传输能力。The second undulations 121 and the fifth undulations 151 are connected by a plurality of fifth connecting bridges 05 arranged in the axial direction, and the specific connection position is between two opposite second arc units 121b and fifth arc units 151b. That is, between the second undulation 121 and the fifth undulation 151, and between the fourth undulation 141 and the sixth undulation 161, there is a crest-to-crest arrangement; the design of the crest-to-crest makes the two ends of the stent body region have a good Radial support force while ensuring excellent force transmission capability.
第四波形物141与第六波形物161由多个沿轴向布置的第六连接桥06连接,具体连接位置为两个相对的第四圆弧单元141b与第六圆弧单元161b之间。The fourth undulation 141 and the sixth undulation 161 are connected by a plurality of sixth connecting bridges 06 arranged in the axial direction, and the specific connection position is between two opposite fourth arc units 141b and sixth arc units 161b.
第一波形物绕线11包含3~4个螺旋周期。第一波形物绕线11的每个螺旋周期包含16个第一波形物111;第二波形物绕线12包含9个第二波形物121;第三波形物绕线13包含6个第三波形物131;第四波形物绕线14包含7个第四波形物141;第五波形物绕线15包含8个第五波形物151;第六波形物绕线16包含8个第六波形物161。所以支架在一定程度上短于普通支架。The first wave winding 11 includes 3-4 helical periods. Each spiral period of the first undulation winding 11 includes 16 first undulations 111; the second undulation winding 12 includes 9 second undulations 121; the third undulation winding 13 includes 6 third undulations 131; the fourth undulation 14 includes 7 fourth undulations 141; the fifth undulation 15 includes 8 fifth undulations 151; the sixth undulation 16 includes 8 sixth undulations 161 . So the stent is shorter than normal stents to a certain extent.
第一波形物绕线11螺旋角为70度,可赋予其良好的柔顺性和充足轴向与径向支撑力;;第二波形物绕线12螺旋角度为78°-82°;第三波形物绕线13螺旋角度为70°-75°;第四波形物绕线14螺旋角度为75°-85°,使得其在两端和中央第一波形物绕线11之间有着平缓,均匀的过渡,便于力和势能的传递,便于支架压握和释放。The helix angle of the first corrugated object winding 11 is 70 degrees, which can give it good flexibility and sufficient axial and radial support; the second corrugated object winding 12 has a helix angle of 78°-82°; the third waveform The helix angle of the object winding 13 is 70°-75°; the helix angle of the fourth wave object winding 14 is 75°-85°, so that it has a gentle and uniform gap between the two ends and the first wave object winding 11 in the center. The transition is convenient for the transmission of force and potential energy, and it is convenient for the support to be gripped and released.
所述B型第三连接桥03b连接于第二波形物绕线12的第二筋条105a的长度的32%-40%处,偏向第一波形物111一侧。The B-type third connecting bridge 03b is connected to 32%-40% of the length of the second rib 105a of the second wave winding 12, and is biased to the first wave 111 side.
第一连接桥01、第二连接桥02、第三连接桥03、第四连接桥04倾斜方向相同。第一连接桥01,A型第三连接桥03a的倾斜角度范围:68°-72°;B型第三连接桥03b倾斜角度为66°-70°;连接于第二波形物绕线12最下方的第二圆弧单元121b的第二连接桥02倾斜角度范围为68°-72°,其余的第二连接桥02a倾斜角度为55°-72°;第四连接桥04倾斜角度为32°-35°。这个角度排布,能最大程度上便于支架热塑定型时残余应力的消除,也最大程度上提高了支架的柔顺性。The first connecting bridge 01, the second connecting bridge 02, the third connecting bridge 03, and the fourth connecting bridge 04 have the same inclination direction. The first connection bridge 01, the inclination angle range of the third connection bridge 03a of type A: 68°-72°; the inclination angle of the third connection bridge 03b of type B is 66°-70°; The inclination angle range of the second connection bridge 02 of the second arc unit 121b below is 68°-72°, and the inclination angle of the remaining second connection bridges 02a is 55°-72°; the inclination angle of the fourth connection bridge 04 is 32° -35°. Arranging at this angle can facilitate the elimination of residual stress during thermoplastic shaping of the bracket to the greatest extent, and also improve the flexibility of the bracket to the greatest extent.
任意一个连接有第一连接桥01的第一圆弧单元111b的两侧具有3-4个未连接第一连接桥01的第一圆弧单元111b,这种比例分布确保了支架主体区优异的柔顺性,同时在一定程度上,充足的轴向支撑。任意一个连接有第二连接桥02的第二圆弧单元121b两侧具有3-4个未连接第二连接桥02的第二圆弧单元121b;任意一个连接有A型第三连接桥03a的第三圆弧单元131b两侧具有3-4个未连接任意连接桥的第三圆弧单元131b。任意一个连接有第四连接桥04的圆弧单元两侧具有3-4个未连接任意连接桥的圆弧单元,以配合中央区和两端。There are 3-4 first arc units 111b not connected to the first connecting bridge 01 on both sides of any first arc unit 111b connected to the first connecting bridge 01. This proportional distribution ensures excellent Compliant and, to a certain extent, ample axial support. There are 3-4 second arc units 121b not connected to the second connecting bridge 02 on both sides of any second arc unit 121b connected to the second connecting bridge 02; any one connected to the third connecting bridge 03a of type A There are 3-4 third arc units 131b on both sides of the third arc unit 131b that are not connected to any connecting bridge. There are 3-4 arc units not connected with any connecting bridge on both sides of any arc unit connected with the fourth connecting bridge 04, to match the central area and the two ends.
第一筋条111a长度保持一致,使区域均匀平整;第二筋条121a长度从上而下呈公比为1-1.1的等比数列递增;第三筋条131a长度从上而下呈公比为1-1.15的等比数列递增;第四筋条141a长度从上而下呈公比为1-1.2的等比数列递增,使得区域箍力均匀,按比例渐强渐弱分布,一定程度上确保了支架的规则性和稳定性;第五筋条151a和第六筋条161a长度保持一致。且第五筋条151a和第六筋条161a的长度不相等,便于支架释放时定位,且释放后不易在管腔中滑落。任一第二筋条121a的长度均长于第一筋条111a、第三筋条131a和第四筋条141a;第二筋条121a的宽度宽于其他筋条的宽度。The length of the first rib 111a is consistent to make the area even and flat; the length of the second rib 121a increases from top to bottom in a geometric sequence with a common ratio of 1-1.1; the length of the third rib 131a is in a common ratio from top to bottom The geometric sequence of 1-1.15 increases; the length of the fourth rib 141a increases from top to bottom in a geometric sequence with a common ratio of 1-1.2, so that the regional hoop force is uniform, and the distribution is gradually stronger and weaker in proportion. The regularity and stability of the bracket are ensured; the lengths of the fifth rib 151a and the sixth rib 161a are consistent. Moreover, the lengths of the fifth rib 151a and the sixth rib 161a are not equal, which is convenient for positioning when the stent is released, and is not easy to slide down in the lumen after the release. The length of any second rib 121a is longer than that of the first rib 111a, the third rib 131a and the fourth rib 141a; the width of the second rib 121a is wider than that of other ribs.
第一连接桥01长度一致;第五连接桥05长度从上而下呈公比为1-1.2的等比数列递增;第六连接桥06长度从上而下呈公比为1-1.1的等比数列递增。且最短的第五连接桥05长度大于第五筋条151a长度的1/4。The length of the first connecting bridge 01 is the same; the length of the fifth connecting bridge 05 increases from top to bottom in a geometric sequence with a common ratio of 1-1.2; the length of the sixth connecting bridge 06 in a common ratio of 1-1.1 from top to bottom is equal Incremental than the sequence. And the length of the shortest fifth connecting bridge 05 is greater than 1/4 of the length of the fifth rib 151a.
所述第一连接桥01的两个连接端之间竖直跨度间隔一个第一连接圆弧111b。同理,所述第二连接桥02,第三连接桥03和第四连接桥04的两个连接端之间竖直跨度间隔一个连接圆弧。The vertical span between the two connection ends of the first connection bridge 01 is separated by a first connection arc 111b. Similarly, the vertical span between the two connection ends of the second connection bridge 02 , the third connection bridge 03 and the fourth connection bridge 04 is separated by a connection arc.
定位桥06一端连接显影环21,另一端与第六筋条161a相连;定位桥06的长度为第六筋条161a长度的0.5-1倍,确保了支架释放力的平稳性。显影点211的横截最大宽度为第六筋条161a宽度的6-7倍,所以显影点的面积较正常支架的显影面积大,赋予了支架良好的显影性和精确定位。One end of the positioning bridge 06 is connected to the developing ring 21, and the other end is connected to the sixth rib 161a; the length of the positioning bridge 06 is 0.5-1 times the length of the sixth rib 161a, which ensures the stability of the release force of the bracket. The maximum cross-sectional width of the developing point 211 is 6-7 times of the width of the sixth rib 161a, so the area of the developing point is larger than that of a normal bracket, which endows the bracket with good development and precise positioning.
作为本领域的公知常识,显影点211焊接的显影金属的材质包括但不仅限于黄金金属和钽金属。As common knowledge in the field, the material of the developing metal welded to the developing point 211 includes but not limited to gold metal and tantalum metal.
此类支架本体第一波形物绕线11区域较短,形成短支架本体;多个短支架在病变腔体内替代长支架,串联使用,所以极大了改善了植入支架后的腔体的柔顺性,也较少了金属接触面积,从而可以减少由支架带来的ISR(支架内再狭窄)现象,同时也降低了支架过长带来了支架断裂的风险。This type of stent body has a relatively short first corrugated winding 11 area, forming a short stent body; multiple short stents replace long stents in the lesion cavity and are used in series, so the compliance of the cavity after the stent is implanted is greatly improved It also reduces the metal contact area, which can reduce the ISR (in-stent restenosis) phenomenon caused by the stent, and also reduce the risk of stent fracture caused by the stent being too long.
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