WO2016149997A1 - Échafaudage de valvule ayant une longueur de compression réduite et dispositif de remplacement de valvule avec échafaudage de valvule - Google Patents

Échafaudage de valvule ayant une longueur de compression réduite et dispositif de remplacement de valvule avec échafaudage de valvule Download PDF

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Publication number
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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WIPO (PCT)
Prior art keywords
valve
section
length
support
transition section
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PCT/CN2015/078943
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English (en)
Chinese (zh)
Inventor
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/fr

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

Abstract

L'invention concerne un échafaudage de valvule ayant une longueur de compression réduite et un dispositif de remplacement de valvule avec l'échafaudage de valvule, l'échafaudage de valvule comprenant une endoprothèse à filet de support tubulaire, dont une extrémité est une section de transition. Le rapport de la longueur axiale de la section de transition avant et après la compression est égal à 1. La longueur axiale de la section de transition représente au moins 25 % de la longueur totale de l'endoprothèse à filet de support. La section de transition est constituée de barres droites s'étendant le long de l'axe de l'échafaudage de la valvule, chaque barre droite étant uniformément répartie le long d'une direction circonférentielle. L'échafaudage de valvule peut réduire le changement de longueur de l'échafaudage de valvule avant et après la compression, améliorer la conformité de flexion de l'échafaudage de valvule, garantir que l'échafaudage de valvule conserve une bonne propriété de compression et une résistance simultanément, faire en sorte que l'échafaudage de valvule atteigne le site d'implantation avec succès dans le corps humain et réduire le risque de complications après une opération chirurgicale.
PCT/CN2015/078943 2015-03-26 2015-05-14 Échafaudage de valvule ayant une longueur de compression réduite et dispositif de remplacement de valvule avec échafaudage de valvule WO2016149997A1 (fr)

Applications Claiming Priority (2)

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CN201510136641.4 2015-03-26
CN201510136641.4A CN104720937B (zh) 2015-03-26 2015-03-26 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

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US10653523B2 (en) * 2017-01-19 2020-05-19 4C Medical Technologies, Inc. Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves
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CN112089508B (zh) * 2020-08-28 2022-11-18 江苏大学 一种抗迁移主动脉瓣膜支架
CN113730039A (zh) * 2021-10-08 2021-12-03 广东脉搏医疗科技有限公司 一种支架瓣膜
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