WO2017124375A1 - 一种医用自膨胀支架 - Google Patents

一种医用自膨胀支架 Download PDF

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Publication number
WO2017124375A1
WO2017124375A1 PCT/CN2016/071576 CN2016071576W WO2017124375A1 WO 2017124375 A1 WO2017124375 A1 WO 2017124375A1 CN 2016071576 W CN2016071576 W CN 2016071576W WO 2017124375 A1 WO2017124375 A1 WO 2017124375A1
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WO
WIPO (PCT)
Prior art keywords
transition
top section
expanding stent
stent
sawtooth
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PCT/CN2016/071576
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English (en)
French (fr)
Inventor
王成
Original Assignee
浙江巴泰医疗科技有限公司
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Priority to PCT/CN2016/071576 priority Critical patent/WO2017124375A1/zh
Publication of WO2017124375A1 publication Critical patent/WO2017124375A1/zh

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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
    • A61F2/02—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
    • 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
    • A61F2/88—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 formed as helical or spiral coils

Definitions

  • the invention relates to the technical field of implantable medical instruments, in particular to a medical self-expanding stent.
  • the medical stent can be placed in the diseased blood vessel segment to support and smooth the blood vessel wall, and is often used for angioplasty to repair and reconstruct blood vessels. Placement of the stent within the damaged arterial segment prevents elastic retraction and arterial closure, as well as preventing localized incision of the artery along the intermediate layer.
  • the stent can be used in any human physiological lumen, such as the arteries, veins, bile ducts, urinary tract, digestive tract, tracheobronchial tree, brain water tube or the lumen of the genitourinary system, and of course can also be placed in the lumen of the animal.
  • stents in terms of deployment in a blood vessel: a self-expanding stent and a balloon-expandable stent.
  • the balloon-expandable stent inserts an unexpanded stent into the damaged area of the blood vessel.
  • the balloon is inflated by inflating the balloon by inflating the balloon, and the inflation process reshapes the atheroma.
  • the stent is fixed in the damaged blood vessel.
  • a problem with the balloon-expandable stent is that, as time passes, if the stent lacks expansion elasticity, the inner diameter of the stent gradually becomes smaller, and eventually collapses due to the natural elastic retraction of the blood vessel.
  • self-expanding stents are self-expanding and have many different designs including: spiral, circular, cylindrical, rolled, stepped, high-order coiled, braided or mesh.
  • the self-expanding stent is composed of a superelastic metal or a shape memory metal (see, for example, U.S. Patent No. 6,013,854 to Moriuchi), by inserting a stent in a compressed state into a damaged narrow blood vessel segment, once the compression force is removed, the stent self The lumen that swells and fills the blood vessels.
  • a tube having an outer diameter smaller than the inner diameter of the damaged blood vessel region can be used to compress the stent. When the stent is released from the restricted state in the tube, the stent expands to restore its original shape, thereby adhering to the vessel wall and firmly fixing the vessel in.
  • a stent formed in a simple cylindrical shape is not easily compressed, resulting in difficulty in inserting the stent into a damaged portion of the blood vessel safely.
  • One of the prior art stent designs that overcomes this problem is to provide a stent formed by a zigzag-shaped element, as described in U.S. Patent No. 5,562,697 to Christians.
  • the stent formed by the zigzag pattern has flexibility in the axial direction so that the stent can be transported and deformed as the vessel deforms.
  • this type of stent often lacks sufficient radial strength to maintain The openness of the blood vessels after elastic retraction.
  • the serrated elements can be coupled to the connecting elements.
  • U.S. Patent No. 6,042,597 to Kveen et al. discloses a balloon expansion stent formed by a continuous helical element having a wavy portion forming peaks and troughs, adjacent undulating portions All peaks are connected by curve elements Pick up. The connecting elements between adjacent undulating portions may impair the softness of the stent.
  • the other method is to provide a plurality of interconnected units, which are in the form of a diamond or a rhomboid, such as a stent design disclosed in U.S. Patent No. 6,063,113 to retet al.
  • the stent has a rigidly interlocking unit, so this type of stent has a relatively high stiffness and cannot be bent to accommodate changes in vessel shape.
  • the invention provides a geometric design for the bracket, which has good softness, sufficient radial strength and axial strength at the same time, and has good use effect, and can keep the blood vessel unblocked for a long time without failing.
  • the design also allows it to be inserted into complex small-diameter blood vessels that dynamically respond to changes in blood pressure.
  • the invention provides a medical self-expanding stent.
  • the stent made by the design has good flexibility, high flexibility, high radial strength and high axial strength, and exerts a good smoothing effect and is effective for a long time.
  • a specific technical solution of the present invention is as follows: a medical self-expanding stent, the stent comprising
  • a body comprising a plurality of sets of first circumferential windings integrally connected, the first circumferential winding having a plurality of circumferentially spirally arranged first sawtooth undulations, adjacent to the first circumferential windings a first connecting bridge connection;
  • the first sawtooth undulation includes two adjacent first lengths of the first pillar and a first top section connecting the adjacent first pillars;
  • the first connecting bridge is connected to the first Between a top segment;
  • transition zone being disposed at an end of the body, the transition zone comprising one of an adjacent connected transition section and a transitional section, one of the transition section and the transition section
  • main bodies are connected by a second connecting bridge;
  • the stent is tubular in structure and has a collapsed diameter for placement into a blood vessel and an expanded diameter for abutting in the blood vessel.
  • one of the transition segments includes a plurality of second sawtooth undulations; and the second transition segment includes a third sawtooth undulation and a fourth sawtooth undulation correspondingly disposed along the longitudinal direction of the bracket.
  • the third sawtooth undulation and the fourth sawtooth undulation are connected by a transition bridge, and the third sawtooth undulation, the fourth sawtooth undulation and the transition bridge together form a plurality of closed support frames body.
  • said second sawtooth undulation comprises two adjacent second struts of unequal length and a second top section connecting adjacent said second struts; said third sawtooth undulation comprising two adjacent ones, etc. a long third pillar and a connection adjacent the third pillar a third top section; the fourth sawtooth undulation includes four adjacent equal length fourth pillars and a fourth top section connecting adjacent the fourth pillars; the transition bridge is connected to the third top Between the segment and the fourth top segment; the second connecting bridge is connected between the second top segment and the first top segment and between the fourth top segment and the first top segment .
  • the length of the second leg increases clockwise or counterclockwise relative to the long axis of the stent; the length of the transition bridge increases clockwise or counterclockwise relative to the long axis of the stent.
  • the second pillar and the transition bridge have the same length increasing direction.
  • one side of the third sawtooth undulation is connected to one side of the second sawtooth undulation and is arranged circumferentially flush with respect to the long axis of the bracket, and one of the fourth sawtooth undulations The side is connected to the other side of the second sawtooth undulation and is circumferentially spirally arranged with respect to the long axis of the bracket.
  • the angle of the second connecting bridge with respect to the long axis of the bracket is 30 to 50 degrees.
  • the transition bridge is parallel with respect to the long axis of the stent.
  • the second leg has a length ranging from 0.5 to 1.2 times the first leg.
  • the length of the transition bridge varies within a range of 0.1 to 1.0 times the length of the first leg.
  • the third leg and the fourth leg are equal in length and both are shorter than the length of the first leg.
  • the angle of the first connecting bridge with respect to the long axis of the bracket is 60 to 80 degrees.
  • said bracket further comprises an end region provided at an end of said transition region, said end region comprising at least one set of second circumferential windings, said end region being connected to said transition region by a third connection
  • the bridges are connected, and the second circumferential winding comprises a plurality of circumferentially arranged fifth sawtooth undulations.
  • said fifth sawtooth undulation comprises adjacent two equal length fifth struts and a fifth top section connecting adjacent said fifth struts, said third connecting bridge being connected to said fifth top section Between the second top section and the fifth top section and the third top section.
  • the second top segment corresponding to the shortest one of the second pillars is connected to the fifth top segment through the third connecting bridge, and the longest one of the transition bridges corresponds to the third top
  • the segment and the fifth top segment are connected by the same third connecting bridge, and the second top segment and the third top segment are flush with each other with respect to a circumferential circumference of the bracket.
  • the third connecting bridge is parallel with respect to the long axis of the bracket.
  • said second circumferential winding forms an outer flare relative to the longitudinal axis of said stent when said stent is in the expanded state.
  • the external expansion angle of the outer flare relative to the long axis of the bracket is 8 to 10 degrees.
  • the length of the fifth leg is greater than the length of the first leg.
  • said end region further comprises a developer disposed on said fifth top segment.
  • the transition zone of the mode has a second sawtooth undulation with a large circumferential span
  • the first Due to its dense structure, the two sawtooth undulations have problems of being difficult to compress or insufficiently compressed, and their radial strength is not high enough, the vascular support is not good, and as the circumference span becomes larger, the first
  • the longitudinal dimension of the two sawtooth undulations is increased, so that the structure of the second sawtooth undulation is unstable, and the supporting force is weakened;
  • the second transition zone may have a more stable strength and higher space structure and support capability than one of the transition sections. It is also feasible to separately adopt the transition section to form the entire transition zone.
  • the transition zone of the method has a section of the closed support frame having a large circumferential span, the third sawtooth undulation of the closed support frame, the fourth sawtooth undulation and The size of the transition bridge may gradually become larger, in particular, the length of the transition bridge may become large, and the strength of the transition bridge may be weakened, which in turn makes the closed support frame structure unstable, weakening its Supporting power.
  • the stent in the transition zone consisting of the second transition section is not good or long-lasting, and there will be vascular stenosis and even vascular occlusion.
  • Applicant's analysis revealed that since the human body "attacks" the stent that is considered to be a foreign body, the site where the stent and the arterial membrane are in contact is treated as a wounded area, thereby automatically repairing it, and inflammation occurs at the stent of the artery.
  • scar tissue hyperplasia occurs around the stent, and when the scar tissue is severely proliferated, the unsettled arteries may be re-stenosis or even blocked.
  • the invention combines one of the transition sections and the transition section, and the circumferential span of one of the transition sections and the transition section can be adjusted and controlled within a reasonable range, and the two types are The respective defects of the method are minimized and have the following significant technical effects:
  • the overall structural composition of the bracket is combined with good material selection and processing technology in actual production, the axial bending and stretching performance is good, and the radial supporting force is strong, so that the bracket has good flexibility and high diameter.
  • the direction and high axial strength can also be ensured, the structure is tight, and the expansion is uniform;
  • the structural design of the second transition section enables the space shape after expansion to be more stable, further improving the radial support force and the axial expansion capability;
  • the structural design of one of the transition sections can help to adjust the circumferential span range of the transition section two, so that the structural strength of the second transition section is maintained at a preferred value, while its own circumferential span range It can also be adjusted within the preferred effect value; it can also help increase the amount of drug coating applied, improve the anti-distraction effect, and exert good and lasting performance.
  • the technical advantage of the invention is that the medical self-expanding stent has reasonable structure and convenient use, and the whole stent has good flexibility, high axial strength and high radial strength, and can have sufficient axial force and radial direction in the blood vessel.
  • the force causes the stent to expand in a timely, complete and uniform manner, and the support for the blood vessel wall is even and stable.
  • the force at both ends is uniform, the shape is good, and the utility model has good long-lasting smoothness during use, and greatly improves the use effect. ,Extended service life.
  • FIG. 1 is a schematic view showing the overall structure of a bracket according to an embodiment of the present invention.
  • FIG. 2 is a partial structural schematic view of the first sawtooth undulation of FIG. 1;
  • Figure 3 is a partial structural schematic view of the transition zone and the end zone of Figure 1;
  • FIG. 4 is a schematic structural view of an external flared structure of a stent according to an embodiment of the present invention.
  • the names of the parts corresponding to the numbers in the figure are: 1-body, 11-first circumference winding, 111-first pillar, 112-first top section, 2-transition zone, 21-transition section, 211- Second pillar, 212 - second top section, 22 - transition section two, 221 - third pillar, 222 - third top section, 223 - fourth pillar, 224 - fourth top section, 225 - transition bridge, 3 - end region, 31 - second circumferential winding, 311 - fifth pillar, 312 - fifth top section, 32 - developing body, 4 - first connecting bridge, 5 - second connecting bridge, 6 - third connection bridge.
  • a medical self-expanding stent has a tubular structure and has a collapsed diameter into which the blood vessel can be placed and an expanded diameter that abuts in the blood vessel.
  • the bracket comprises a body 1 comprising a plurality of sets of first circumferential windings 11 integrally connected, the first circumferential winding 11 comprising a plurality of circumferentially helically arranged first sawtooth undulations, the first sawtooth undulation comprising adjacent Two equal length first pillars 111 and first top sections 112 connecting adjacent first pillars 111; adjacent first circumferential windings 11 having a spiral space between adjacent first circumferential windings 11
  • the connecting bridge 4 is connected, and the first connecting bridge 4 is connected to the first top section 112 across the spiral spacing space along the longitudinal direction of the bracket; preferably, every third first top section 112 is disposed on the first circumferential winding 11.
  • the first connecting bridge 4 but does not exclude that a very few places cannot be arranged according to the interval due to the overall frame design, and there may be a situation such as two intervals.
  • the first connecting bridge 4 is adjacent to the first circumferential winding 11
  • the number of settings is between 5 and 8.
  • This design facilitates the conduction of force during the pushing and releasing of the bracket, connecting the first connecting bridge 4 of the adjacent two first top sections 112 with the spiral direction of the first sawtooth undulation Conversely, and the adjacent two first top segments 112 are not through the first connection 4 directly facing the connection, but staggered from each other, preferably separated by a first top section 112, such that the angle of the first connecting bridge 4 relative to the long axis of the stent is preferably 80 degrees, this design is beneficial to the stent release process There can be enough axial force to release the stent in the blood vessel in a timely and complete manner, avoiding delayed release or incomplete release, and enhancing axial bending performance;
  • the transition zone 2 is disposed at the end of the main body 1, and the transition zone 2 includes one of the adjacent transition sections 21 and the transition section 22, one of the transition sections 21 and the transition section 22 and the main body 1
  • Each of the transition sections includes a plurality of second sawtooth undulations
  • the transition section 22 includes a third sawtooth undulation and a fourth sawtooth correspondingly disposed along the longitudinal direction of the stent.
  • the undulation, the third sawtooth undulation and the fourth sawtooth undulation are connected by a transition bridge 225, and the third sawtooth undulation, the fourth sawtooth undulation and the transition bridge 225 together form a plurality of closed support frames;
  • the second sawtooth undulation includes two adjacent second struts 211 of unequal length and a second top section 212 connecting adjacent second struts 211.
  • the length of the second leg 211 increases clockwise or counterclockwise relative to the long axis of the stent.
  • the length of the second pillar 211 varies within a range of 0.5 to 1.2 times of the first pillar 111, and the support is unstable, and the thickness is too small to reduce the flexibility, expansion or shrinkage, and the thickness or diameter of the second pillar 211 is actually small.
  • the maximum span is the same as that of the first pillar 111, ensuring that the overall structure design is reasonable and has superior effects.
  • the third sawtooth undulation includes two adjacent third struts 221 and a third top 222 connecting adjacent third ribs 221;
  • the fourth sawtooth undulation includes two adjacent equal length fourth struts 223 and Connecting the fourth top section 224 of the adjacent fourth pillar 223;
  • the transition bridge 225 is connected between the third top section 222 and the fourth top section 224;
  • the second connecting bridge 5 is connected to the second top section 212 and the first top section Between 112 and between the fourth top section 224 and the first top section 112.
  • the lengths of the third pillars 221 and the fourth pillars 223 are equal and the lengths of the two pillars 223 are equal to the length of the first pillars 111.
  • the thicknesses or the maximum radial spans of the third pillars 221 and the fourth pillars 223 are the same as those of the first pillars 111. Therefore, the overall structure design is reasonable and has a superior effect.
  • the length of the transition bridge 225 increases clockwise or counterclockwise relative to the long axis of the bracket, the transition bridge 225 is parallel with respect to the long axis of the bracket, and the direction in which the length of the transition bridge 225 increases is the same as the direction in which the length of the second strut 211 increases.
  • the length of the transition bridge 225 varies within a range of 0.1 to 1.0 times the length of the first strut 111. If the transition bridge 225 is too long, the supporting force is weakened.
  • the actual transition bridge 225 The thickness or the maximum radial span is the same as that of the first pillar 111 to achieve a reasonable overall structural design and superior effects.
  • one of the transition sections 21 is provided with one second connecting bridge 4 every three second top sections 212 (corresponding to every three first top sections 112), and preferably every third of the transition sections 22
  • the fourth top section 224 (corresponding to every three first top sections 112) is provided with one second connecting bridge 4, but it is not excluded that a very few places cannot be arranged according to the interval according to the overall frame design, and there may be intervals such as
  • the angles of the two second connecting bridges 5 with respect to the long axis of the bracket may be different, preferably 80 degrees and 45 degrees in sequence, which is beneficial to the conduction of the force during the pushing and releasing of the bracket. It can facilitate sufficient axial force during stent release to release the stent into the blood vessel in a timely and complete manner, avoiding delayed release or incomplete
  • the actual closed support frame After the actual closed support frame is unfolded, it is an even-numbered edge such as a hexagon or an octagon.
  • the number of sides depends on the setting of the transition bridge 225.
  • the radial strength of the bracket After expansion and expansion, the radial strength of the bracket is greatly improved, and the structural shape is stable and firmly attached. Combined with the inner wall of the supporting vessel, Not easy to shrink.
  • one side of the third sawtooth undulation is connected to one side of the second sawtooth undulation and both are arranged flush with respect to the circumference of the longitudinal axis of the bracket.
  • One side of the fourth sawtooth undulation is connected to the other side of the second sawtooth undulation and is helically arranged circumferentially with respect to the long axis of the bracket.
  • the longest one of the second pillars 211 is connected to a third top section 222 and a fourth top section 224, respectively, and adjacent to the third top section 222
  • the other third top section 222 and the other fourth top section 224 adjacent to the fourth top section are preferably separated by a partition, that is, without a transition bridge 225, so as to prevent the joint from being unable to expand when the bracket is inflated.
  • the fully extended condition occurs, that is, an octagon appears after the joint is unfolded.
  • the shape of one of the final transition section 21 and the transition section 22 is a right-angled trapezoid, one end is smoothly connected with the spiral end of the main body 1, and the other end is kept in a circumferentially flush arrangement, and the overall performance is good, and the force and expansion are uniform. Easy to press and hold.
  • the lengths of the adjacent second pillars 211 are equal or the lengths of the third pillars 221 and the fourth pillars 223 are not equal, and the length of the corresponding transition bridge 225 is not long with respect to the longitudinal axis of the bracket.
  • the hour or counterclockwise increase is either jagged or inversely increased, and individual or a combination of these solutions is also possible.
  • the entire transition zone After the expansion and expansion, the entire transition zone is guaranteed to have good torsion flexibility, and has good support strength, good axial expansion and bending performance, and suitably improves the coating amount and fit of the drug coating. It has a good and lasting smooth blood vessel effect.
  • the bracket further includes an end region 3 disposed at an end of the transition zone 2, the end region 3 including a set of second circumferential windings 31, the end region 3 and the transition region 2 being connected by a third connecting bridge 6, the second circumference winding
  • the line 31 includes a plurality of circumferentially arranged fifth sawtooth undulations; the fifth sawtooth undulation includes two adjacent equal length fifth struts 311 and a fifth top section 312 connecting the adjacent fifth struts 311.
  • the third connecting bridge 6 is connected between the fifth top section 312 and the second top section 212 and between the fifth top section 312 and the third top section 222.
  • the entire end region 3 forms a well-balanced closed-loop structure, which is advantageous for uniform stress on both ends of the stent during being pushed and released.
  • the second circumferential windings 31 may also be provided in groups of two or more.
  • the second circumferential windings 31 may be interconnected by re-setting the connecting bridges in a manner similar to the manner in which the third connecting bridges 6 are disposed.
  • the second circumferential winding forms an outer flare relative to the longitudinal axis of the stent in the expanded state of the stent
  • the external expansion angle ⁇ of the outer flare relative to the longitudinal axis of the stent is preferably 10 degrees. It can stably and firmly adhere to the inner wall of the blood vessel and avoid the deviation of the stent in the blood vessel.
  • the tubular stent is engraved, it is placed into a specific shaping fixture (if the outer diameter of the stent is required to be 4 mm, Then the shaping fixture is 4mm. If the external expansion is required, then the shaping fixture needs to be made into a tapered surface with an expansion, which can be realized by heat treatment.
  • the second top section 212 and the fifth top section 312 corresponding to the shortest one of the second pillars 211 are connected by the third connecting bridge 6, and the longest one of the transition bridges 225 corresponds to the third top section 222 and the fifth top
  • the segment 312 is connected by the same third connecting bridge 6, the design makes the overall connection consistency improved, and the increase of the length of the fifth post 311 can facilitate the amplification of the conductive force during the crimping of the bracket and prevent the bracket from being curled up. Start.
  • the third connecting bridge 6 is parallel with respect to the long axis of the bracket, and preferably every fourth fifth top section 312 on the second circumferential winding 31 (corresponding to every fourth second top section 212 or every fourth third top section 222) Or a third connecting bridge 6 is disposed every four consecutively of the second top section 212 and the third top section 222, but it is not excluded that the extremely small places cannot be arranged according to the interval due to the overall frame design, and may be With two intervals, the design facilitates the conduction of force during the push and release of the stent, which facilitates the release of sufficient axial force during stent release to allow the stent to be released into the blood vessel in a timely and complete manner, avoiding delays. Incomplete release or release, enhanced axial bending performance.
  • the length of the fifth pillar 311 is greater than the length of the first pillar 111, and the thickness or the maximum radial span of the actual fifth pillar 311 is the same as that of the first pillar 111, so as to ensure a reasonable overall design and a superior effect, the design is advantageous.
  • the crimping of the bracket, if the fifth pillar 311 is short, is easy to lift when the bracket is pressed, and the crimping is very difficult.
  • the end portion 3 further includes a developing body 32 disposed on the fifth top portion 312.
  • the developing body 32 is an X-ray-opaque marker such as enamel or platinum or gold, and can be positioned in the blood vessel in the stent.
  • the number of the developing bodies 32 in the single end portion 3 is preferably set to six, which increases the stress point of the stent when released, which is favorable for the conduction of the release force.

Abstract

一种医用自膨胀支架，所述支架包括主体（1），所述主体（1）包括多组连成整体的第一圆周绕线（11），所述第一圆周绕线（11）具有多个圆周向螺旋排布的第一锯齿波形物，相邻所述第一圆周绕线（11）通过第一连接桥（4）连接；所述第一锯齿波形物包括相邻两个等长的第一支柱（111）和连接相邻所述第一支柱（111）的第一顶段（112）；所述第一连接桥（4）连接于所述第一顶段（112）之间；过渡区（2），所述过渡区（2）设置于所述主体（1）的端部，所述过渡区（2）包括相邻连接的过渡段之一（21）和过渡段之二（22），所述过渡段之一（21）及所述过渡段之二（22）与所述主体（1）之间均通过第二连接桥（5）相连接；所述支架为管状结构且具有于血管中置入的皱缩直径和于血管中抵扩的膨胀直径。该支架结构合理、使用方便，具有高柔顺性、高径向及轴向强度，使用效果良好持久。

Description

一种医用自膨胀支架 技术领域
本发明涉及植入式医疗器具技术领域，具体是一种医用自膨胀支架。
背景技术
医用支架可置入病变的血管段内，用来支撑、畅通血管壁，常用于血管成形术以便修复和重建血管。在受损的动脉段内放置支架可防止弹性回缩和动脉闭合，也可防止动脉沿着中间层的局部切开。理论上支架可用于任何人体生理管腔中，诸如动脉、静脉、胆管、泌尿道、消化道、气管支气管树、大脑水管或生殖泌尿系统的内腔，当然也可以放置在动物内腔内。
通常，按照在血管内展开的方式来分，有两种类型的支架：自膨胀支架和球囊扩张型支架。球囊扩张型支架实为将一未膨胀的支架插入血管内的受损区域，通过在支架内侧放置一气球，并对气球充气而使支架膨胀，充气膨胀过程重塑了动脉粥样斑并将支架固定在受损的血管内。球囊扩张型支架存在的问题是，随着时间的推移，如果支架缺乏膨胀弹性，支架的内径逐渐变小，最终由于血管的自然弹性退缩而塌陷。
相反，自膨胀支架能够自行膨胀定型，它有许多不同的设计包括：螺旋形、圆形、圆柱形、卷状、阶梯管型、高阶盘绕型、编织型或网格型等。自膨胀支架由超弹性金属或形状记忆金属构成(例如，见授予Moriuchi的美国专利第6,013,854号)，通过将压缩状态下的支架插入受损的狭窄的血管段内，一旦压缩力消除，支架自我膨胀而充满血管的内腔。外径比受损的血管区域的内径小的管子可用于压缩支架，当支架从管子内的限制状态被释放时，支架膨胀而恢复其原来形状，从而紧抵血管壁并牢牢地固定在血管里。
目前自膨胀支架的各种设计还具有一定的功能缺陷。例如，以简单的圆柱形形成的支架不容易被压缩，导致难以将支架安全顺地插入血管的受损部位。克服这个问题的现有技术中的支架设计的一种方法是提供一种由锯齿形元件形成的支架，如授予Christiansen的美国专利第5,562,697号所述的。由锯齿形图形形成的支架具有在轴向方向上的柔软性，以便支架的输送并能随着血管的形变而相应地形变，然而，这种类型的支架常常缺乏足够的径向强度以维持在弹性退缩后的血管的开放性。
为了提供锯齿形设计增加的径向强度，锯齿形元件可与连接元件连接。授予Kveen等人的美国专利第6,042,597号公开了一种球囊膨胀支架，它由具有波浪形部分的连续的螺旋元件形成的，而该波浪形部分形成波峰和波谷，相邻的波浪形部分的所有波峰通过曲线元件连 接。在各相邻波浪形部分之间的连接元件可能削弱支架的柔软性。
另一种方法是提供许多互相连接的单元，这些单元呈菱形或偏菱形，如授予Karteladze等人的美国专利第6,063,113号或授予Moriuchi的美国专利第6,013,584号公开的一种支架设计，这种类型的支架具有硬性地互锁的单元，因此这种类型的支架具有比较高的刚性，不能弯曲以适应血管形状的变化。
因为构成支架的螺旋绕线的端部不平，所以绕线的最后一部分与支架的其他区域按不同的速率膨胀，这个问题即不均匀膨胀可通过在支架的主体与端部区之间引入过渡区解决，例如美国专利第6,878,162号、第6,969,402号和第7,169,175号中对过渡区的描述。然而这类过渡区结构仍会在支架的均匀压缩及膨胀、支架的药物涂覆及其与血管接触率、支架的径向支撑强度等功能方面有所欠缺，使用效果差，容易再次出现血管堵塞的状况。
本发明提供一种针对支架的几何设计，使其同时具有较好的柔软性、足够的径向强度及轴向强度，并且使用效果较好，能够长久保持血管畅通而不失效，支架的这种设计还允许它被插入复杂的小直径血管，动态地响应血压的变化。
发明内容
本发明提供一种医用自膨胀支架，利用该设计制成的支架具有较好的柔软性、高灵活性、高径向强度以及高轴向强度，并且发挥良好的畅通效果，长久有效。
本发明的具体技术方案如下，一种医用自膨胀支架，所述支架包括
主体，所述主体包括多组连成整体的第一圆周绕线，所述第一圆周绕线具有多个圆周向螺旋排布的第一锯齿波形物，相邻所述第一圆周绕线通过第一连接桥连接；所述第一锯齿波形物包括相邻两个等长的第一支柱和连接相邻所述第一支柱的第一顶段；所述第一连接桥连接于所述第一顶段之间；
过渡区，所述过渡区设置于所述主体的端部，所述过渡区包括相邻连接的过渡段之一和过渡段之二，所述过渡段之一及所述过渡段之二与所述主体之间均通过第二连接桥相连接；
所述支架为管状结构且具有用于置入血管的皱缩直径和用于在血管中抵扩的膨胀直径。
作为优选，所述过渡段之一包括多个第二锯齿波形物；所述过渡段之二包括沿着所述支架长轴方向上下对应设置的第三锯齿波形物和第四锯齿波形物，所述第三锯齿波形物与所述第四锯齿波形物之间通过过渡桥相连接，所述第三锯齿波形物、所述第四锯齿波形物及所述过渡桥共同形成了多个封闭支撑框体。
作为优选，所述第二锯齿波形物包括相邻两个不等长的第二支柱和连接相邻所述第二支柱的第二顶段；所述第三锯齿波形物包括相邻两个等长的第三支柱和连接相邻所述第三支柱 的第三顶段；所述第四锯齿波形物包括相邻两个等长的第四支柱和连接相邻所述第四支柱的第四顶段；所述过渡桥连接于所述第三顶段与所述第四顶段之间；所述第二连接桥连接于所述第二顶段与所述第一顶段之间以及所述第四顶段与所述第一顶段之间。
作为优选，所述第二支柱的长度相对于所述支架长轴顺时针或逆时针增大；所述过渡桥的长度相对于所述支架长轴顺时针或逆时针增大。
作为优选，所述第二支柱及所述过渡桥的长度增大的方向相同。
作为优选，所述第三锯齿波形物的一侧与所述第二锯齿波形物的一侧相连并均相对于所述支架长轴圆周向齐平排布，所述第四锯齿波形物的一侧与所述第二锯齿波形物的另一侧相连并均相对于所述支架长轴圆周向螺旋排布。
作为优选，所述第二连接桥相对于所述支架长轴的夹角为30～50度。
作为优选，所述过渡桥相对于所述支架长轴平行。
作为优选，所述第二支柱的长度范围在所述第一支柱的0.5～1.2倍内。
作为优选，所述过渡桥长度的变化范围在所述第一支柱长度的0.1～1.0倍内。
作为优选，所述第三支柱与所述第四支柱的长度相等且该两者长度均小于所述第一支柱的长度。
作为优选，所述第一连接桥相对于所述支架长轴的夹角为60～80度。
作为优选，所述支架还包括设于所述过渡区端部的端部区，所述端部区包括至少1组第二圆周绕线，所述端部区与所述过渡区通过第三连接桥相连，所述第二圆周绕线包括多个圆周向齐平排布的第五锯齿波形物。
作为优选，所述第五锯齿波形物包括相邻两个等长的第五支柱和连接相邻所述第五支柱的第五顶段，所述第三连接桥连接于所述第五顶段与所述第二顶段之间以及所述第五顶段与所述第三顶段之间。
作为优选，所述第二支柱中最短的一个所对应的第二顶段与所述第五顶段通过所述第三连接桥相连，所述过渡桥中最长的一个所对应的第三顶段与所述第五顶段通过该同一第三连接桥相连，该第二顶段与该第三顶段相对于所述支架长轴圆周向齐平相连。
作为优选，所述第三连接桥相对于所述支架长轴平行。
作为优选，所述第第二圆周绕线在所述支架膨胀状态时形成一个相对于所述支架长轴的外扩口。
作为优选，所述外扩口相对于所述支架长轴的外扩夹角为8～10度。
作为优选，所述第五支柱的长度大于所述第一支柱的长度。
作为优选，所述端部区还包括设于所述第五顶段上的显影体。
经申请人试验，单独采用所述过渡段之一构成整个过渡区的方式可行，但存在问题：该方式的过渡区会有圆周向跨度很大的一段所述第二锯齿波形物，所述第二锯齿波形物因其结构密集形式，因此会有不易压缩或压缩量不够大的问题，并且其径向强度不够高，血管支撑作用不好，并且随着圆周跨度越来越大，所述第二锯齿波形物的纵向尺寸增大，更使得第二锯齿波形物的结构不稳定，削弱其支撑力；
所述过渡区之二相对于所述过渡段之一会因为其结构形式而具有更稳定强度更高的空间结构及支撑能力，单独采用所述过渡段之二构成整个过渡区的方式也可行，但还是会存在问题：该方式的过渡区会有圆周向跨度很大的一段所述封闭支撑框体，所述封闭支撑框体的所述第三锯齿波形物、所述第四锯齿波形物及所述过渡桥的尺寸会逐渐变大，特别是所述过渡桥的长度会变得很大，所述过渡桥的强度会被削弱，这反而使得所述封闭支撑框体结构不稳定，削弱其支撑力。而在实际使用过程中，发现过渡区全由过渡段之二组成的支架效果并不好也不长久，会再出现血管狭窄甚至血管堵塞。申请人分析后发现，由于人体会对被认为是外来异物的支架进行“攻击”，把支架和动脉膜接触的部位当成创伤区，从而自动对其进行修复，于是动脉的支架处就会出现炎症反应，在支架周围会出现疤痕组织增生，这种疤痕组织增生严重的时候可以造成畅通了的动脉重新狭窄，甚至堵塞。为了解决这问题会采取在支架上涂覆药物涂层的方法，而因为所述封闭支撑框体在膨胀后会出现中空面，如果整个过渡段全是过渡区，就会有过多且过大的接触盲区，药物涂覆量大幅减少，使用效果差、使用寿命短。
本发明将所述过渡段之一和所述过渡段之二相结合，所述过渡段之一和所述过渡段之二的圆周向跨度能够相互调整并控制在合理范围内，将上述两种方式各自的缺陷降到最低，并具有如下显著技术效果：
1、所述支架的整体结构组成加上实际生产中良好的材料选择及加工工艺，轴向弯曲及伸缩性能良好，径向支撑力强，使得所述支架的柔顺性较好，并且其高径向及高轴向强度也能够得到保证，结构紧密，膨胀均匀一致；
2、所述过渡段之二的结构设计能够使得其在膨胀后的空间形态更趋稳定，进一步提高径向支撑力和轴向伸缩能力；
3、所述过渡段之一的结构设计既能帮助调整所述过渡段之二的圆周向跨度范围，使得所述过渡段之二的结构强度保持在较佳值，同时自身的圆周向跨度范围也可调整在较佳效果值内；又能帮助增加药物涂层的施用量，改善防排异效果，发挥良好且持久的使用效能。
本发明的技术优点在于所述医用自膨胀支架结构合理、使用方便，整个支架具有较好的柔顺性、高轴向强度和高径向强度，在血管中能够有足够的轴向力和径向力使支架及时、完整、均匀地膨胀，对于血管壁的支撑均匀稳定，在推送和释放过程中两端受力均匀，定型良好，并在使用过程中具有良好持久的通畅能力，大幅提高使用效果，延长使用寿命。
附图说明
图1为本发明实施例的支架整体结构示意图；
图2为图1中所述第一锯齿波形物的局部结构示意图；
图3为图1中所述过渡区和所述端部区的局部结构示意图；
图4为本发明实施例的支架外扩口结构示意图；
图中编号对应的各部位名称分别为：1-主体，11-第一圆周绕线，111-第一支柱，112-第一顶段，2-过渡区，21-过渡段之一，211-第二支柱，212-第二顶段，22-过渡段之二，221-第三支柱，222-第三顶段，223-第四支柱，224-第四顶段，225-过渡桥，3-端部区，31-第二圆周绕线，311-第五支柱，312-第五顶段，32-显影体，4-第一连接桥，5-第二连接桥，6-第三连接桥。
具体实施方式
下面将结合附图，通过具体实施例对本发明作进一步说明：
见图1、图2及图3，一种医用自膨胀支架，支架为管状结构且具有可置入血管的皱缩直径和于血管中抵扩的膨胀直径。支架包括主体1，主体1包括多组连成整体的第一圆周绕线11，第一圆周绕线11包括多个圆周向螺旋排布的第一锯齿波形物，第一锯齿波形物包括相邻两个等长的第一支柱111和连接相邻第一支柱111的第一顶段112；相邻第一圆周绕线11之间具有螺旋间隔空间，相邻第一圆周绕线11通过第一连接桥4连接，第一连接桥4沿着支架长轴方向跨过螺旋间隔空间与第一顶段112相连；第一圆周绕线11上优选为每隔3个第一顶段112设置1个第一连接桥4，但不排除极个别地方由于整体构架设计而无法全部按照此间隔数布置，可能会有间隔如2个的状况，第一连接桥4在相邻第一圆周绕线11之间的设置数目在5～8个，该设计有利于支架被推送和释放过程中力的传导，连接相邻两个第一顶段112的第一连接桥4与第一锯齿波形物的螺旋方向相反，且该相邻两个第一顶段112不是通过第一连接桥4直接正对连接，而是相互错开，优选为隔开1个第一顶段112，使得第一连接桥4相对于支架长轴的夹角优选为80度，这种设计有利于支架释放过程中能够有足够的轴向力可以使支架及时且完整地释放在血管中，避免延迟释放或释放不完整，加强轴向弯曲性能；
过渡区2，过渡区2设置于主体1的端部，过渡区2包括相邻连接的过渡段之一21和过渡段之二22，过渡段之一21及过渡段之二22与主体1之间均通过第二连接桥5相连接；过渡段之一21包括多个第二锯齿波形物；过渡段之二22包括沿着支架长轴方向上下对应设置的第三锯齿波形物和第四锯齿波形物，第三锯齿波形物与第四锯齿波形物之间通过过渡桥225相连接，第三锯齿波形物、第四锯齿波形物及过渡桥225共同形成了多个封闭支撑框体；
第二锯齿波形物包括相邻两个不等长的第二支柱211和连接相邻第二支柱211的第二顶段212。第二支柱211的长度相对于支架长轴顺时针或逆时针增大。第二支柱211的长度在第一支柱111的0.5～1.2倍范围内变化，过大会使支撑不稳，过小会降低柔顺性、膨胀或皱缩困难，实际第二支柱211的厚度或者说径向最大跨度与第一支柱111相同，保证整体结构设计合理并具有较优效果。
第三锯齿波形物包括相邻两个等长的第三支柱221和连接相邻第三支柱221的第三顶段222；第四锯齿波形物包括相邻两个等长的第四支柱223和连接相邻第四支柱223的第四顶段224；过渡桥225连接于第三顶段222与第四顶段224之间；第二连接桥5连接于第二顶段212与第一顶段112之间以及第四顶段224与第一顶段112之间。第三支柱221与第四支柱223的长度相等且该两者长度均小于第一支柱111的长度，实际第三支柱221、第四支柱223的厚度或者说径向最大跨度与第一支柱111相同，从而保证整体结构设计合理并具有较优效果。过渡桥225的长度相对于支架长轴顺时针或逆时针增大，过渡桥225相对于支架长轴平行，且过渡桥225长度增大的方向与第二支柱211长度增大的方向相同。过渡桥225长度在第一支柱111长度的0.1～1.0倍范围内变化，过渡桥225过长会削弱其支撑力，过短会使其膨胀或皱缩困难、柔顺性降低，实际过渡桥225的厚度或者说径向最大跨度与第一支柱111相同，以达到合理的整体结构设计及较优效果。过渡段之一21上优选为每隔3个第二顶段212(对应每隔3个第一顶段112)设置1个第二连接桥4，过渡段之二22上优选为每隔3个第四顶段224(对应每隔3个第一顶段112)设置1个第二连接桥4，但不排除极个别地方由于整体构架设计而无法全部按照此间隔数布置，可能会有间隔如2个的状况，该两种第二连接桥5相对于支架长轴的夹角可以不同，优选可依次为80度、45度，该设计有利于支架被推送和释放过程中力的传导，有利于支架释放过程中能够有足够的轴向力可以使支架及时且完整地释放在血管中，避免延迟释放或释放不完整，加强轴向弯曲性能。
实际封闭支撑框体展开后为六边形或八边形等偶数边形，边数取决于过渡桥225的设置方式，其膨胀展开后会大幅提高支架径向强度，结构形态稳定，牢牢贴合并支撑血管内壁， 不易退缩。在过渡段之一与过渡段之二的连接时优选表现为，第三锯齿波形物的一侧与第二锯齿波形物的一侧相连并均相对于所述支架长轴圆周向齐平排布，第四锯齿波形物的一侧与第二锯齿波形物的另一侧相连并均相对于所述支架长轴圆周向螺旋排布。再具体到两者连接处优选来说也就是第二支柱211中最长的那一个上下端分别连接一个第三顶段222和一个第四顶段224，并且与该第三顶段222相邻的另一第三顶段222、与该第四顶段相邻的另一第四顶段224之间优选为隔断即无过渡桥225进行桥接，这样设计是为了防止该连接处在支架膨胀时可能无法完全撑开的情况发生，也即该连接处展开后会出现一个八边形。最终过渡段之一21和过渡段之二22整体的形状为直角梯形，一端和主体1的螺旋式端部顺畅衔接，另一端保持圆周向齐平排布，整体性能好，受力及膨胀均匀，易于压握操作。
另外，虽然图未示出，但相邻第二支柱211长度相等或第三支柱221与第四支柱223的长度不尽相等，相应的过渡桥225的长度也不是相对于所述支架长轴顺时针或逆时针增大而是参差不齐或是反向增大，这些方案的单个或是其组合也是可行的。
整个过渡区在膨胀张开后，保证具有良好的扭转柔顺性，并且具有良好的支撑强度，轴向伸缩及弯曲性能较好，同时适宜地提高了其药物涂层涂覆量及其贴合度，具有良好持久畅通血管效果。
支架还包括设于过渡区2端部的端部区3，端部区3包括1组第二圆周绕线31，端部区3与过渡区2通过第三连接桥6相连，第二圆周绕线31包括多个圆周向齐平排布的第五锯齿波形物；第五锯齿波形物包括相邻两个等长的第五支柱311和连接相邻第五支柱311的第五顶段312，第三连接桥6连接于第五顶段312与第二顶段212之间以及第五顶段312与第三顶段222之间。整个端部区3形成匀称闭环结构，有利于支架在被推送和释放过程中两端受力均匀。其实，第二圆周绕线31也可以设置2组甚至更多，第二圆周绕线31之间可通过再设置连接桥进行互连，大体方式与第三连接桥6的设置方式相类似。
在图4中还能看到第二圆周绕线在支架膨胀状态时形成一个相对于支架长轴的外扩口，外扩口相对于支架长轴的外扩夹角α为较优选的10度，能够稳定牢固地贴合血管内壁，避免支架在血管中的偏位，这个方案在该管状支架雕刻完成后，将其放入一个特定的定型治具(若需要支架达到的外径是4mm，那么定型治具就是4mm，若需要外扩口，那么就需要将定型治具制成具有外扩的锥面)内，通过热处理就可以实现。第二支柱211中最短的一个所对应的第二顶段212与第五顶段312通过第三连接桥6相连，过渡桥225中最长的一个所对应的第三顶段222与第五顶段312通过该同一第三连接桥6相连，该设计使得整体连接一致性提高，第五支柱311长度增加可有利于压握支架过程中传导力的放大，并防止支架压握时翘 起。第三连接桥6相对于支架长轴平行，第二圆周绕线31上优选每隔4个第五顶段312(对应每隔4个第二顶段212或者每隔4个第三顶段222或者每隔第二顶段212和第三顶段222连续的共4个)设置1个第三连接桥6，但不排除极个别地方由于整体构架设计而无法全部按照此间隔数布置，可能会有间隔如2个的状况，该设计有利于支架被推送和释放过程中力的传导，有利于支架释放过程中能够有足够的轴向力可以使支架及时且完整地释放在血管中，避免延迟释放或释放不完整，加强轴向弯曲性能。第五支柱311的长度大于第一支柱111的长度，实际第五支柱311的厚度或者说径向最大跨度与第一支柱111相同，以保证整体结构设计合理并具有较优效果，该设计有利于支架的压握，如果第五支柱311偏短，则在压握支架时容易翘起，而导致压握十分困难。端部区3还包括设于第五顶段312上的显影体32，显影体32为钽或白金或黄金等X光不能透过的标识物，能够在支架于血管中导向定位起到很大作用，单个端部区3内显影体32优选设置6个，增加支架在释放时的受力点，有利于释放力的传导。

Claims (20)

  1. 一种医用自膨胀支架，其特征在于：所述支架包括：
    主体(1)，所述主体(1)包括多组连成整体的第一圆周绕线(11)，所述第一圆周绕线(11)包括多个圆周向螺旋排布的第一锯齿波形物，相邻所述第一圆周绕线(11)通过第一连接桥(4)连接；所述第一锯齿波形物包括相邻两个等长的第一支柱(111)和连接相邻所述第一支柱(111)的第一顶段(112)；所述第一连接桥(4)连接于所述第一顶段(112)之间；
    过渡区(2)，所述过渡区(2)设置于所述主体(1)的端部，所述过渡区(2)包括相邻连接的过渡段之一(21)和过渡段之二(22)，所述过渡段之一(21)及所述过渡段之二(22)与所述主体(1)之间均通过第二连接桥(5)相连接；
    所述支架为管状结构且具有用于置入血管中的皱缩直径和于血管中抵扩的膨胀直径。
  2. 根据权利要求1所述的一种医用自膨胀支架，其特征在于：所述过渡段之一(21)包括多个第二锯齿波形物；所述过渡段之二(22)包括沿着所述支架长轴方向上下对应设置的第三锯齿波形物和第四锯齿波形物，所述第三锯齿波形物与所述第四锯齿波形物之间通过过渡桥(225)相连接，所述第三锯齿波形物、所述第四锯齿波形物及所述过渡桥(225)共同形成了多个封闭支撑框体。
  3. 根据权利要求2所述的一种医用自膨胀支架，其特征在于：所述第二锯齿波形物包括相邻两个不等长的第二支柱(211)和连接相邻所述第二支柱(211)的第二顶段(212)；所述第三锯齿波形物包括相邻两个等长的第三支柱(221)和连接相邻所述第三支柱(221)的第三顶段(222)；所述第四锯齿波形物包括相邻两个等长的第四支柱(223)和连接相邻所述第四支柱(223)的第四顶段(224)；所述过渡桥(225)连接于所述第三顶段(222)与所述第四顶段(224)之间；所述第二连接桥(5)连接于所述第二顶段(212)与所述第一顶段(112)之间以及所述第四顶段(224)与所述第一顶段(112)之间。
  4. 根据权利要求3所述的一种医用自膨胀支架，其特征在于：所述第二支柱(211)的长度相对于所述支架长轴顺时针或逆时针增大；所述过渡桥(225)的长度相对于所述支架长轴顺时针或逆时针增大。
  5. 根据权利要求4所述的一种医用自膨胀支架，其特征在于：所述第二支柱(211)及所述过渡桥(225)的长度增大的方向相同。
  6. 根据权利要求2或3或4或5所述的一种医用自膨胀支架，其特征在于：所述第三锯齿波形物的一侧与所述第二锯齿波形物的一侧相连并均相对于所述支架长轴圆周向齐平排布，所述第四锯齿波形物的一侧与所述第二锯齿波形物的另一侧相连并均相对于所述支架长轴圆周向螺旋排布。
  7. 根据权利要求3所述的一种医用自膨胀支架，其特征在于：所述第二支柱(211)的长度变化范围为所述第一支柱(111)的0.5～1.2倍。
  8. 根据权利要求3所述的一种医用自膨胀支架，其特征在于：所述第三支柱(221)与所述第四支柱(223)的长度相等且该两者长度均小于所述第一支柱(111)的长度。
  9. 根据权利要求3所述的一种医用自膨胀支架，其特征在于：所述过渡桥(225)长度的变化范围为所述第一支柱(111)长度的0.1～1.0倍。
  10. 根据权利要求2所述的一种医用自膨胀支架，其特征在于：所述第二连接桥(5)相对于所述支架长轴的夹角为30～50度。
  11. 根据权利要求1所述的一种医用自膨胀支架，其特征在于：所述过渡桥(225)相对于所述支架长轴平行。
  12. 根据权利要求1所述的一种医用自膨胀支架，其特征在于：所述第一连接桥(4)相对于所述支架长轴的夹角为60～80度。
  13. 根据权利要求1或12所述的一种医用自膨胀支架，其特征在于：所述第一连接桥(4)在相邻所述第一圆周绕线(11)之间的设置数目范围为5～8个。
  14. 根据权利要求3所述的一种医用自膨胀支架，其特征在于：所述支架还包括设于所述过渡区(2)端部的端部区(3)，所述端部区(3)包括第二圆周绕线(31)，所述端部区(3)与所述过渡区(2)通过第三连接桥(6)相连，所述第二圆周绕线(31)包括多个圆周向齐平排布的第五锯齿波形物。
  15. 根据权利要求14所述的一种医用自膨胀支架，其特征在于：所述第五锯齿波形物包括相邻两个等长的第五支柱(311)和连接相邻所述第五支柱(311)的第五顶段(312)，所述第三连接桥(6)连接于所述第五顶段(312)与所述第二顶段(212)之间以及所述第五顶段(312)与所述第三顶段(222)之间。
  16. 根据权利要求15所述的一种医用自膨胀支架，其特征在于：所述第二支柱(211)中最短的一个所对应的第二顶段(212)与所述第五顶段(312)通过所述第三连接桥(6)相连，所述过渡桥(225)中最长的一个所对应的第三顶段 (222)与所述第五顶段(312)通过该同一第三连接桥(6)相连。
  17. 根据权利要求16所述的一种医用自膨胀支架，其特征在于：所述第三连接桥(6)相对于所述支架长轴平行。
  18. 根据权利要求15所述的一种医用自膨胀支架，其特征在于：所述第五支柱(311)的长度大于所述第一支柱(111)的长度。
  19. 根据权利要求14所述的一种医用自膨胀支架，其特征在于：所述第二圆周绕线在所述支架膨胀状态时形成一个相对于所述支架长轴的外扩口。
  20. 根据权利要求19所述的一种医用自膨胀支架，其特征在于：所述外扩口相对于所述支架长轴的外扩夹角为8～10度。
PCT/CN2016/071576 2016-01-21 2016-01-21 一种医用自膨胀支架 WO2017124375A1 (zh)

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