WO2016149997A1 - 减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置 - Google Patents

减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置 Download PDF

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WO2016149997A1
WO2016149997A1 PCT/CN2015/078943 CN2015078943W WO2016149997A1 WO 2016149997 A1 WO2016149997 A1 WO 2016149997A1 CN 2015078943 W CN2015078943 W CN 2015078943W WO 2016149997 A1 WO2016149997 A1 WO 2016149997A1
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valve
section
length
support
transition section
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PCT/CN2015/078943
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English (en)
French (fr)
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曾敏
罗拉里
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杭州启明医疗器械有限公司
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Publication of WO2016149997A1 publication Critical patent/WO2016149997A1/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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a valve stent with reduced compression length and a valve replacement device having the same.
  • Fallot tetralogy is the most common type of congenital heart disease in surviving infants, accounting for 10 to 15% of all types of congenital heart disease.
  • the tetralogy of Fallot consists of the following four types of malformations: (1) pulmonary stenosis, which is more common in funnel stenosis, followed by funnel and valvular stenosis, and the degree of stenosis can be aggravated with age; (2) ventricular septal defect, Defects of the high-level membrane; (3) Aortic straddle, the aorta rides across the left and right ventricles, with the development of the aorta, the right-span phenomenon can gradually increase, about 25% of patients with right aortic arch; (4 Right ventricular hypertrophy, resulting in increased right ventricular load after pulmonary stenosis. Among the above four abnormalities, pulmonary stenosis has the greatest influence on the pathophysiology of children.
  • a second thoracotomy can be used to implant the valve, or an interventional method can be used to implant the artificial pulmonary valve.
  • the interventional method can greatly reduce the surgical trauma of the patient and provide another treatment route for patients who cannot undergo surgery.
  • the aorta After the first patch operation, the aorta is soft and the diameter is enlarged. Therefore, the length and diameter of the artificial pulmonary valve to be implanted are large.
  • the pulmonary valve stent is placed in the sheath in a compressed state before being implanted into the human body, and is transported into the human body by the sheath tube, and the pulmonary valve stent is released from the sheath tube, and the released pulmonary valve stent is released. Return to the natural state and support The role of the prosthetic valve.
  • the main body structure is a diamond-shaped mesh.
  • a pulmonary artery stent including a tubular support grid, and a support frame. An inflow section and an outflow section which are radially expanded at both ends and flared, the support grid having a plurality of first cells distributed circumferentially adjacent to the outflow section, the first cell adopting a diamond shape.
  • the size changes before and after compression in both the longitudinal direction and the diameter direction, and the implantation path of the pulmonary valve sequentially passes through the vein, the right atrium, the right ventricle, and the main pulmonary artery.
  • the curvature of the entry path is large, and if the length of the pulmonary valve is compressed too long, it will seriously affect the compliance during the delivery of the instrument and increase the difficulty of transportation.
  • the invention provides a valve stent with reduced compression length, which can reduce the length change of the valve stent before and after compression, improve the bending compliance of the valve stent, and enable the valve to smoothly reach the implantation position in the human body, thereby ensuring a smooth operation process. Perform to reduce the risk of postoperative vascular complications.
  • a valve stent for reducing compression length comprising a tubular support grid, wherein a section of the support grid is a transition section, and the ratio of axial lengths before and after compression of the transition section is equal to one.
  • the heart valve stent of the prior art When the heart valve stent of the prior art is delivered into the human body through the delivery system, the heart valve stent is usually compressed and placed in the instrument loading portion of the delivery system, and the instrument loading portion in which the valve stent is placed is the hardest in the entire sheath. In part, in order to minimize the length of the hardest portion to meet the need for a more curved implant path, the length of the heart valve stent after compression is reduced.
  • the support grid in the present invention refers to the portion of the valve stent that is used to distract the blood vessel in addition to the positioning member, and is generally tubular, with blood flowing inside the tubular body and interacting with the prosthetic valve inside the tubular body.
  • the support grid is not limited to a cylinder extending in an equal diameter, and the end of the support grid may expand or contract in the radial direction.
  • the present invention provides a transition section on the support grid, and the transition section maintains the axial length unchanged before and after compression, which can be reduced compared with the diamond mesh in the prior art.
  • the length in the axial direction before and after compression changes.
  • the transition section has an axial length that is at least 25% of the total length of the support grid. Only when the ratio of the axial length of the transition section to the total length of the support grid reaches 25% or more, the effect of the transition section can be manifested, that is, based on the existence of the transition section, the length of the compressed support grid can be reduced to Meet the requirements of bending compliance, so that the support grid can smoothly reach the expected part of the human body to ensure the smooth operation of the operation.
  • the transition section can reduce the length variation in the axial direction before and after the compression of the support grid, the length of the transition section is not as long as possible, because the diamond mesh has a relatively large change in the axial direction before and after compression, but
  • the structure of the diamond mesh ensures that the support grid is strong enough to withstand long periods of blood washout, and the diamond mesh structure allows the support grid to be compressed and placed in the sheath.
  • the axial length of the transition section is 40 to 90% of the total length of the support grid. Further preferably, the axial length of the transition section is 50 to 80% of the total length of the support grid.
  • the transition section is formed by a plurality of straight rods extending axially along the valve support, each straight rod being evenly arranged in the circumferential direction.
  • the straight rod extends along the axial direction of the valve support, and the length of the straight rod, that is, the axial length of the transition portion, is evenly arranged along the circumference, which can ensure the symmetry of the overall structure of the support grid, and when the blood vessel is washed for a long time in the blood vessel, The force is even, and the tilting is less likely to occur, thereby causing damage to the blood vessel wall.
  • the support grid is connected to the inflow section and the outflow section at both axial ends, and the two ends of the transition section are connected or directly connected to the inflow section and the outflow section by a mesh section.
  • transition section When the transition section is connected to the inflow section or the outflow section by the grid section, the transition section and the grid section together constitute the support grid of the present invention.
  • the inflow section and the outflow section are both flared, so that after the valve stent is implanted into the human body, it is not easy to be displaced with the movement of the heart.
  • both the inflow section and the outflow section in the valve stent may be the first release end, and the inflow section or the outflow section at the first release end, which is called a flared section.
  • the flared section is connected to all end nodes on the corresponding side of the support grid.
  • All end nodes are connected with the flared section to avoid isolated vertices at the non-end of the valve stent, eliminating the phenomenon of spikes after the valve stent is compressed into the sheath.
  • the outer edge of the flared section is surrounded by a plurality of curved support bars, and the support frame is opposite to the support bar
  • the end nodes should be connected to the support bar.
  • the end nodes intersect on the support strip or are connected to the support strip by the intersection of the lead strips.
  • each support bar Two ends of each support bar are respectively connected to one end node of the support grid, the middle of the support strip extends along the axial direction of the support grid, and the portion of the support strip adjacent to the end node is outwardly bent to form a flare.
  • the connecting strip gradually moves away from the supporting grid by the extending path of the corresponding end node to the supporting strip.
  • the leader strip also has a suitable curvature, and the degree of bending is adapted to the curved shape of the support strip, and the leader strip and the support strip are located on the same smooth curved surface.
  • the angle between the line connecting the two ends of the extension path and the axis of the valve support is 0 to 70 degrees.
  • the length of the lead strip is the shortest.
  • the extension path of the lead strip usually does not coincide with the axis of the valve support. Parallel.
  • the lead strip needs to be connected to the support strip. In order to match the shape of the support strip, the extension path of the lead strip is not easy to have a large angle with the axis of the valve support.
  • the angle between the line connecting the two ends of the extension path and the axis of the valve support is 20 to 60 degrees. Further preferably, the angle between the line connecting the two ends of the extension path and the axis of the valve support is 30 to 45 degrees.
  • the connecting strip is connected with the nearest supporting strip, and the angle between the connecting strip and the supporting strip is an acute angle. With this structure, it is easy to maintain the original mechanical properties.
  • Each of the four adjacent end nodes is a group.
  • the two ends of the support bar are respectively connected with the two end nodes that are the farthest distance, and the two end nodes located in the middle are respectively
  • the connecting strip is connected to the supporting strip on the corresponding side, and the two connecting strips do not intersect each other, and the position where each of the connecting strips intersects the supporting strip is located substantially in the middle of the axial direction of the flared section.
  • the mesh segments are diamond-shaped meshes, and the straight end of each of the transition segments is connected to a corresponding diamond-shaped apex.
  • the ends of the straight rods are connected to the corresponding rhombic vertices.
  • the rhombic grid it is easier to control the uniform alignment of the straight rods in the circumferential direction, which makes the processing easier, and secondly, the exposed end points of the valve holder are less. It is not easy to puncture the sheath or blood vessel.
  • the force of the valve stent is simpler and easier.
  • the structural design of the valve support e.g., selecting the appropriate axial and radial length) also facilitates the positional stability of the valve support in the flowing blood.
  • the ends of the straight rods of the transition section are connected to the rhombic vertices of the diamond-shaped mesh facing the transition section.
  • the two ends of the straight rod are respectively connected with a rhombic apex, and the adjacent two straight rods and the corresponding sides of the rhombic connected to the straight rod form a hexagonal structure, and each inner angle of the hexagon is an obtuse angle.
  • the use of this structure can minimize the number of vertices exposed by the diamond, and the safety of the valve stent is better.
  • the diamond mesh described in the present invention is not a diamond in a strict sense, and the sides of the diamond may be slightly curved, each forming a structure that is relatively close to a circle, and reducing the stress concentration point at the time of stress.
  • the present invention also provides a valve replacement device comprising the valve support and a prosthetic valve secured within the support frame.
  • the support frame and the inflow section of the valve support are covered, and the prosthetic valve can be sewn on the inner wall of the valve support, and can also be installed and fixed by other existing methods.
  • the invention reduces the compression length of the valve stent, can reduce the length change of the valve stent before and after compression, improve the bending compliance of the valve stent, and ensure that the valve stent maintains good compression performance and strength, so that the valve can reach the plant smoothly in the human body. Into the position, reduce the risk of postoperative vascular complications.
  • Figure 1 is a schematic illustration of a first embodiment of a pulmonary artery stent of reduced compression length
  • FIG. 2 is a perspective view of a first embodiment of a pulmonary artery stent with reduced compression length
  • Figure 3 is a schematic view of a second embodiment of a pulmonary artery stent of reduced compression length (the latter half is omitted);
  • Figure 4 is a schematic illustration of an aortic stent with reduced compression length.
  • the pulmonary artery stent with reduced compression length includes a support grid and an inflow section 5 and an outflow section 1 respectively connected to the axial ends of the support grid, and one section of the support grid is a transition section 3 .
  • the transition section 3 is connected to the inflow section 5 through the grid section 13, and the other end of the transition section 3 is connected to the outflow section 1 through the grid section 2, and the grid section 2, the grid section 13 and the transition section 3 together form a support grid .
  • the mesh segment 2 is composed of a continuous diamond shape
  • the mesh segment 13 is composed of a continuous semi-diamond shape
  • the inflow segment 5 is expanded outward in the radial direction to form a flare, and the edge of the diamond is not a strict straight line but a slight direction.
  • the outer bend, the inflow section 5, the mesh section 2, and the mesh section 13 have the same number of rhombic or semi-diamonds in the circumferential direction.
  • the transition section 3 is composed of a plurality of straight rods 7 extending axially along the pulmonary artery stent, and the straight rods 7 are evenly arranged in the circumferential direction, and the axial length of the transition section 3 is 70% of the total length of the support grid.
  • the ends of the straight rods 7 of the transition section 3 are connected to the corresponding rhombic vertices, and the ends of the straight rods 7 of the transition section 3 are connected to the diamond-shaped vertices of the diamond-shaped mesh toward the transition section 3.
  • the straight rods 7 of the transition section 3 and the adjacent rhombic sides form a hexagon, and the inner angles of the hexagons are obtuse angles.
  • this embodiment eliminates the end nodes that are isolated in the pulmonary stent.
  • the radial expansion of the inflow section 5 and the outflow section 1 is flared.
  • the outflow section 1 of the pulmonary artery stent is the first release end, and the outflow section 1 and the corresponding side on the support grid are all The end nodes 4 are connected.
  • the posterior half of the pulmonary stent is omitted in Figure 3, showing only the anterior half of the pulmonary stent.
  • the outer edge of the outflow section 1 is surrounded by a plurality of curved support strips 6, each adjacent four end nodes 4 as a group, in a set of end nodes 4, having a support strip 6 and two lead strips 8
  • the two ends of the support strip 6 are respectively connected to the two end nodes 4 which are farthest apart, and the two end nodes 4 located in the middle are respectively connected by a connecting strip 8 to the support strips 6 on the corresponding sides, these two The strips 8 do not intersect each other, and the position at which each strip 8 intersects the strip 6 is located substantially in the middle of the axial direction of the outflow section 1.
  • the connecting strip 8 gradually deviates from the supporting grid by the extending path of the corresponding end node 4 to the supporting strip 6, and the connecting strip 8 and the branch
  • the angle between the intersections of the stays 6 is an acute angle.
  • the aortic stent of reduced compression length includes a support grid and an outflow section 15 and an inflow section 10 connected at both axial ends of the support grid, and a section of the support grid is a transition section 11.
  • the transition section is connected to the outflow section 15 through the mesh section 9, and the other end of the transition section 11 is connected to the outflow section 10 through the mesh section 14, and the mesh section 14, the mesh section 9 and the transition section 11 together constitute a support grid.
  • the grid section 14 and the grid section 9 are composed of a continuous semi-diamond shape, and the inflow section 10 is expanded outward in the radial direction to form a flare rather than the transition section 11, and the sides of the rhombus are not strictly straight lines but are slightly curved outward.
  • the transition section 11 is formed by a plurality of straight rods 12 extending axially along the aortic stent.
  • the straight rods 12 are evenly arranged in the circumferential direction, and the axial length of the transition section 11 is 80% of the total length of the support grid.
  • the ends of the straight rods 12 of the transition section 11 are connected with the corresponding mesh segments 14 and the semi-diamond vertices of the mesh segments 9.
  • the straight rods 12 of the transition section 11 and the adjacent semi-diamond sides constitute Hexagons, the inner corners of the hexagon are obtuse angles.
  • the length of the valve stent after compression can be greatly reduced. It is assumed that there are n axial diamond-shaped units in a transition section of a supporting grid, and each diamond-shaped unit has an axial growth amount of X after compression than before compression.
  • the length of the support grid is increased by n*X after compression; if the transition is changed to a straight line, the two ends of the transition will have the remaining half of the diamond, and the length of the support frame before and after compression
  • the change is 1*X, and the axial length change before and after the linear portion is compressed is 'zero'.
  • the support grids are all made up of diamond-shaped meshes. Taking the most common 30# flap as an example, there are 12 diamond-shaped grids distributed in the circumferential direction to fix the straight segments of the valve. The length is 30mm, there are 4 diamond lattices in the axial direction. When the valve stent is compressed, the diamond lattice becomes a straight line, and the length of the straight segment changes to about 43.04mm. After adopting the technical solution provided by the present invention, the two in the transitional segment 3 The remaining half of each diamond has a length of about 33.26mm, which reduces the compression length of 9.78mm, and the effect is remarkable.
  • the present invention can reduce the amount of metal material (usually memory alloy, nickel-titanium memory alloy of the present invention) used in the valve stent by nearly half, which can reduce the diameter of the valve stent after compression and improve the bending compliance. Sexuality, the performance of the valve is further improved.
  • metal material usually memory alloy, nickel-titanium memory alloy of the present invention
  • the valve replacement device comprises the aforementioned valve support and is fixed inside the support grid Prosthetic valve. After the valve stent enters the predetermined position of the human body through the delivery system, the valve stent is released and expanded by the sheath tube, and the prosthetic valve fixed inside the valve stent replaces the original valve in the human body, thereby realizing the function of unidirectional passage of blood.

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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

一种减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置，其中，瓣膜支架包括管状的支撑网架，支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。过渡段的轴向长度为支撑网架总长度的至少25％。过渡段由若干沿瓣膜支架轴向延伸的直杆构成，各直杆沿周向均匀排布。该支架能够减小瓣膜支架压缩前后的长度变化，提高瓣膜支架的弯曲顺应性，同时保证瓣膜支架保持良好的压缩性能以及强度，使瓣膜能够在人体内顺利到达植入位置，降低术后发生血管并发症的风险。

Description

减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置 技术领域
本发明涉及医疗器械技术领域，具体涉及一种减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置。
背景技术
法洛四联症是存活婴儿中最常见的发绀型先天性心脏病，发病率占各类先天性心脏病的10～15％。
法洛四联症由以下四种畸形组成：(1)肺动脉狭窄，以漏斗部狭窄多见，其次为漏斗部和瓣膜合并狭窄，狭窄程度可随年龄增加而加重；(2)室间隔缺损，所属高位膜部缺损；(3)主动脉骑跨，主动脉骑跨于左、右心室之上，随着主动脉发育，右跨现象可逐渐加重，约25％病人为右位主动脉弓；(4)右心室肥厚，为肺动脉狭窄后右心室负荷增加导致。以上四种畸形中以肺动脉狭窄对患儿的病理生理影响最大。
在法洛四联症外科手术中，医生在修复肺动脉、肺动脉瓣或右心室漏斗部狭窄时，一般是通过在对应位置植入补片，来解决主肺动脉、肺动脉分支狭窄或肺动脉瓣狭窄的问题。但这种外科手术只是一种姑息疗法，往往会导致肺动脉瓣缺失，待患儿长到成年时，仍需继续针对肺动脉瓣缺失进行治疗。
针对患儿成年后的肺动脉瓣缺失问题，可以采用二次开胸手术植入瓣膜解决，也可以采用介入方法，植入人工肺动脉瓣膜解决。采用介入方法相比外科手术，能够大大降低患者的手术创伤，为不能承受外科手术的患者提供了另一条治疗途径。
患儿经过第一次补片手术后，主动脉松软，直径扩大，因此，所需植入的人工肺动脉瓣膜的长度以及直径尺寸都较大。现有技术中的肺动脉瓣膜支架在植入人体之前，是以压缩的状态置于鞘管中，被鞘管输送到人体中后，肺动脉瓣膜支架由鞘管中释放出来，释放后的肺动脉瓣膜支架恢复到自然状态，起到支撑 假体瓣膜的作用。
现有的肺动脉支架为了便于压缩，主体结构为菱形网格，例如，申请公布号为CN 103431931A的中国发明专利文献公开了一种肺动脉支架，包括管状的支撑网架，以及连接在支撑网架轴向两端且径向膨胀呈扩口的流入段和流出段，所述支撑网架邻近流出段部位具有绕周向分布的若干第一单元格，第一单元格采用菱形。
当肺动脉瓣膜支架的主体部分采用菱形结构时，无论是长度方向还是直径方向，压缩前后的尺寸变化较大，而肺动脉瓣膜的植入路径依次通过静脉、右心房、右心室、主肺动脉，该植入路径的弯曲度较大，肺动脉瓣压缩后的长度如果过长，将严重影响器械输送过程中的顺应性，增加输送难度。
技术问题
本发明提供了一种减小压缩长度的瓣膜支架，能够减小瓣膜支架压缩前后的长度变化，提高瓣膜支架的弯曲顺应性，使瓣膜能够在人体内顺利到达植入位置，保证手术过程的顺利进行，降低术后发生血管并发症的风险。
问题的解决方案
技术解决方案
一种减小压缩长度的瓣膜支架，包括管状的支撑网架，所述支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。
现有技术中的心脏瓣膜支架通过输送***送入人体时，通常是将心脏瓣膜支架压缩后放置在输送***的器械装载部分，而放置有瓣膜支架的器械装载部分是整个鞘管中最坚硬的部分，为了使该最坚硬部分的长度最小，以满足通过弯曲度较大的植入路径的需求，需要将心脏瓣膜支架压缩后的长度减小。
本发明中的支撑网架是指瓣膜支架中除去定位部件之外用于撑开血管的部分，通常为管状，血液在管状内部流动，与管状内部的假体瓣膜相作用。支撑网架并不限于是等径延伸的筒状，支撑网架的端部可以在径向上有膨胀或者收缩。
为了减小支撑网架压缩后的长度，本发明在支撑网架上设置一段过渡段，过渡段在压缩前后保持轴向上长度不变，相比现有技术中的菱形网格，能够减小压缩前后在轴向上的长度变化。
作为优选，所述过渡段的轴向长度为支撑网架总长度的至少25％。只有在过渡段轴向长度与支撑网架总长度之比达到25％以上时，过渡段的作用才能够得以显现，即基于过渡段的存在，使压缩后的支撑网架的长度能够减小到满足弯曲顺应性的要求，使支撑网架能够顺利地到达人体内部预期部位，保证手术的顺利进行。
虽然过渡段能够减小支撑网架压缩前后轴向上的长度变化，但是，过渡段的长度也并非越长越好，因为，菱形网格虽然压缩前后在轴向上的长度变化比较大，但是菱形网格的结构能够保证支撑网架具有足够的强度，能够承受长时间的血液冲刷，且菱形网格的结构使支撑网架能够被压缩，从而放置在鞘管中。
因此，优选地，所述过渡段的轴向长度为支撑网架总长度的40～90％。进一步优选，所述过渡段的轴向长度为支撑网架总长度的50～80％。
作为最简单的实施方式，所述过渡段由若干沿瓣膜支架轴向延伸的直杆构成，各直杆沿周向均匀排布。
直杆沿瓣膜支架的轴向延伸，直杆的长度即过渡段的轴向长度，沿周向均匀排布，可以保证支撑网架整体结构的对称性，在血管中长期经受血流冲刷时，受力均匀，不易发生倾侧，从而对血管壁造成伤害。
作为优选，所述支撑网架轴向两端连接有流入段和流出段，所述过渡段的两端与流入段、流出段之间通过网格段连接或直接连接。
过渡段通过网格段与流入段或流出段连接时，过渡段和网格段共同构成本发明所述的支撑网架。
所述的流入段和流出段均呈扩口，使瓣膜支架植入人体后，不易随心脏的运动而出现位移。
在人体内释放时，瓣膜支架中的流入段和流出段都有可能是先释放端，处在先释放端的流入段或流出段，称为扩口段。扩口段与支撑网架上对应侧的所有端节点相连。
将所有端节点与扩口段相连接，避免在瓣膜支架非端部的部位出现孤立的顶点，消除了瓣膜支架压缩入鞘管后，出现尖刺的现象。
所述扩口段的外边缘由若干弯曲的支撑条围成，支撑网架上与支撑条位置相对 应的端节点均与支撑条相连。所述端节点相交在支撑条上或通过接引条交汇连接至支撑条上。
将所有端节点直接连接或者通过接引条连接至支撑条上，即支撑网架上不存在孤立存在的端节点，每个端节点至少连接有三条线性边，在整个瓣膜支架发生压缩时，端节点不会变形为尖刺。
每根支撑条的两端分别连接支撑网架的一个端节点，支撑条的中部沿支撑网架的轴向延伸，且支撑条邻近端节点的部位向外弯曲以形成扩口。所述接引条由对应端节点至支撑条的延伸路径逐渐背离支撑网架。
接引条也具有适当的弯曲，且弯曲程度与支撑条的弯曲形状相适应，接引条与支撑条位于同一光滑曲面上。
作为优选，延伸路径两端点连线与瓣膜支架轴线的夹角为0～70度。延伸路径与瓣膜支架轴线夹角为0度时，接引条的长度最短，但是，由于接引条以及支撑条均具有弯曲结构，因此，接引条的延伸路径通常不会与瓣膜支架的轴线相平行。接引条需要汇至支撑条上，为了配合支撑条的形状，接引条的延伸路径也不易与瓣膜支架的轴线具有很大的夹角。
优选地，延伸路径两端点连线与瓣膜支架轴线的夹角为20～60度。进一步优选，延伸路径两端点连线与瓣膜支架轴线的夹角为30～45度。
接引条与最邻近的支撑条相连接，接引条与支撑条相交部位的夹角为锐角。采用这种结构易于维持原有的力学性能。
每相邻的四个端节点作为一组，在一组端节点中，所述支撑条的两端分别与距离最远的两个端节点相连接，位于中部的两个端节点分别由一根接引条连接至对应侧的支撑条上，且两根接引条互不相交，每根接引条与支撑条相交的位置大致位于扩口段轴向上的中部。
为了最大程度地保留现有的瓣膜支架结构，使瓣膜支架的加工更容易进行，优选地，所述网格段为菱形网格，过渡段各直杆端头与对应的菱形顶点连接。
各直杆端头与对应的菱形顶点连接，首先，基于菱形网格的对称结构，更易于控制各直杆沿周向均匀排列，使加工更易进行，其次，瓣膜支架上暴露的端点更少，不容易刺破鞘管或者血管，最后，瓣膜支架的受力状态更为简单，便于 瓣膜支架的结构设计(例如选择合适的轴向以及径向长度)同时，也有利于瓣膜支架在流动的血液中保持位置稳定。
作为优选，过渡段各直杆端头连接在菱形网格朝向过渡段的菱形顶点。
直杆的两端分别与一个菱形顶点连接，相邻的两个直杆以及与直杆连接的菱形的相应边构成六边形结构，该六边形的各个内角均为钝角。采用这种结构能够最大程度的减小菱形暴露的顶点数量，使瓣膜支架的使用安全性更好。
本发明中所述的菱形网格，并非是严格意义上的菱形，菱形的各边可以略有弯曲，每个形成相对接近圆形的结构，减少受力时的应力集中点。
本发明还提供了一种瓣膜置换装置，包括所述的瓣膜支架，以及固定在所述支撑网架内部的假体瓣膜。
所述瓣膜支架的支撑网架和流入段均覆膜，假体瓣膜可缝制在瓣膜支架的内壁，也可以采用现有的其他方法进行安装固定。
发明的有益效果
有益效果
本发明减小压缩长度的瓣膜支架，能够减小瓣膜支架压缩前后的长度变化，提高瓣膜支架的弯曲顺应性，同时保证瓣膜支架保持良好的压缩性能以及强度，使瓣膜能够在人体内顺利到达植入位置，降低术后发生血管并发症的风险。
对附图的简要说明
附图说明
图1为减小压缩长度的肺动脉支架的第一种实施方式的示意图；
图2为减小压缩长度的肺动脉支架的第一种实施方式的立体图；
图3为减小压缩长度的肺动脉支架的第二种实施方式的示意图(后半侧省略)；
图4为减小压缩长度的主动脉支架的示意图。
图中：1、流出段；2、网格段；3、过渡段；4、端节点；5、流入段；6、支撑条；7、直杆；8、接引条；9、网格段；10、流入段；11、过渡段；12、直杆；13、网格段；14、网格段；15、流出段。
发明实施例
本发明的实施方式
实施例1
下面结合附图，以肺动脉支架为例，对本发明做进一步阐释。
如图1、图2所示，减小压缩长度的肺动脉支架，包括支撑网架以及分别连接在支撑网架轴向两端的流入段5和流出段1，支撑网架的其中一段为过渡段3。
过渡段3的一端通过网格段13与流入段5相连接，过渡段3的另一端通过网格段2与和流出段1相连接，网格段2、网格段13和过渡段3共同构成支撑网架。网格段2由连续的菱形组成，网格段13由连续的半菱形组成，流入段5相比过渡段3，在径向上向外扩张形成扩口，菱形的边并非严格的直线，而是略向外弯曲，流入段5、网格段2以及网格段13在圆周向上的菱形或半菱形数目相同。
过渡段3由若干沿肺动脉支架轴向延伸的直杆7构成，各直杆7沿周向均匀排布，过渡段3的轴向长度为支撑网架总长度的70％。
过渡段3各直杆7端头与对应的菱形顶点连接，过渡段3各直杆7端头连接在菱形网格朝向过渡段3的菱形顶点。由图1可以看出，过渡段3的各直杆7与相邻的菱形的边构成六边形，六边形的各内角均为钝角。
实施例2
除了与实施例1具有相同的过渡段3结构外，本实施例消除了肺动脉支架中孤立存在的端节点。
如图3所示，流入段5和流出段1的径向膨胀呈扩口，在人体内释放时，肺动脉支架的流出段1为先释放端，流出段1与支撑网架上对应侧的所有端节点4相连。图3中省却了肺动脉支架的后半侧，仅显示肺动脉支架的前半侧。
流出段1的外边缘由若干弯曲的支撑条6围成，每相邻的四个端节点4作为一组，在一组端节点4中，具有一根支撑条6以及两根接引条8，支撑条6的两端分别与相距最远的两个端节点4相连接，位于中部的两个端节点4分别由一根接引条8连接至对应侧的支撑条6上，这两根接引条8互不相交，每根接引条8与支撑条6相交的位置大致位于流出段1轴向上的中部。
接引条8由对应端节点4至支撑条6的延伸路径逐渐背离支撑网架，接引条8与支 撑条6相交部位的夹角为锐角。
实施例3
下面结合附图，以主动脉支架为例，对本发明做进一步阐释。
如图4所示，减小压缩长度的主动脉支架，包括支撑网架以及连接在支撑网架轴向两端的流出段15和流入段10，支撑网架的其中一段为过渡段11。
过渡段的一端通过网格段9与流出段15相连接，过渡段11的另一端通过网格段14与和流出段10相连接，网格段14、网格段9和过渡段11共同构成支撑网架。网格段14、网格段9由连续的半菱形组成，流入段10相比过渡段11在径向上向外扩张形成扩口，菱形的边并非严格的直线，而是略向外弯曲。
过渡段11由若干沿主动脉支架轴向延伸的直杆12构成，各直杆12沿周向均匀排布，过渡段11的轴向长度为支撑网架总长度的80％。
过渡段11各直杆12两端头与对应的网格段14、网格段9的半菱形顶点连接，由图4可以看出，过渡段11的各直杆12与相邻的半菱形的边构成六边形，六边形的各内角均为钝角。
采用本发明的技术方案能够大大减小瓣膜支架压缩后的长度，假定一个支撑网架过渡段轴向菱形单元有n个，每一个菱形单元压缩后比压缩前的轴向增长量为X，则支撑网架压缩后长度增加变化量值为n*X；对比可得，若将过渡段菱形格改变为直线，过渡段的两端将分别剩余各半个菱形格，则支撑网架压缩前后长度变化为1*X，直线部分压缩前后轴向长度变化量为‘零’。举例说明如下：目前最常见的自膨式肺动脉支架中，支撑网架全部由菱形网格构成，以最常见的30#瓣为例，圆周向分布有12个菱形网格，固定瓣膜的直段长度为30mm，轴向上存在4个菱形格，当瓣膜支架被压缩时，菱形格变为直线，直段长度变化为约43.04mm；采用本发明提供的技术方案后，在过渡段3的两端分别剩余各半个菱形格，压缩后直段长度约为33.26mm，减少了9.78mm的压缩长度，效果显著。
除此之外，本发明可以将瓣膜支架所使用的金属材质(通常为记忆合金，本发明采用镍钛记忆合金)用量减少近一半，既可以降低瓣膜支架压缩后的直径，又能够改善弯曲顺应性，使瓣膜的通过性能得到进一步提升。
本发明提供的瓣膜置换装置，包括前述的瓣膜支架，以及固定在支撑网架内部 的假体瓣膜。瓣膜支架通过输送***进入人体预定位置后，瓣膜支架由鞘管中释放并膨胀，瓣膜支架内部固定的假体瓣膜替代人体内原有的瓣膜，实现使血液单向通过的功能。

Claims (8)

  1. 一种减小压缩长度的瓣膜支架，包括管状的支撑网架，其特征在于，所述支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。
  2. 如权利要求1所述的减小压缩长度的瓣膜支架，其特征在于，所述过渡段的轴向长度为支撑网架总长度的至少25％。
  3. 如权利要求2所述的减小压缩长度的瓣膜支架，其特征在于，所述过渡段的轴向长度为支撑网架总长度的40～90％。
  4. 如权利要求1～3任一所述的减小压缩长度的瓣膜支架，其特征在于，所述过渡段由若干沿瓣膜支架轴向延伸的直杆构成，各直杆沿周向均匀排布。
  5. 如权利要求4所述的减小压缩长度的瓣膜支架，其特征在于，所述支撑网架轴向两端连接有流入段和流出段，所述过渡段的两端与流入段、流出段之间通过网格段连接或直接连接。
  6. 如权利要求5所述的减小压缩长度的瓣膜支架，其特征在于，所述网格段为菱形网格，过渡段各直杆端头与对应的菱形顶点连接。
  7. 如权利要求6所述的减小压缩长度的瓣膜支架，其特征在于，过渡段各直杆端头连接在菱形网格朝向过渡段的菱形顶点。
  8. 一种瓣膜置换装置，其特征在于，包括如权利要求1～7任一项所述的瓣膜支架，以及固定在所述支撑网架内部的假体瓣膜。
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