WO2021121307A1 - Endoprothèse pour artère pulmonaire de nourrisson - Google Patents

Endoprothèse pour artère pulmonaire de nourrisson Download PDF

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Publication number
WO2021121307A1
WO2021121307A1 PCT/CN2020/137146 CN2020137146W WO2021121307A1 WO 2021121307 A1 WO2021121307 A1 WO 2021121307A1 CN 2020137146 W CN2020137146 W CN 2020137146W WO 2021121307 A1 WO2021121307 A1 WO 2021121307A1
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WIPO (PCT)
Prior art keywords
stent
pulmonary artery
rod
unit section
unit
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Application number
PCT/CN2020/137146
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English (en)
Chinese (zh)
Inventor
邱芹
周庆亮
刘晓芳
孟坚
Original Assignee
北京迈迪顶峰医疗科技股份有限公司
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Publication of WO2021121307A1 publication Critical patent/WO2021121307A1/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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough

Definitions

  • This application relates to the technical field of vascular intervention, in particular to a pulmonary artery stent for infants.
  • pulmonary artery stenosis The causes of pulmonary artery stenosis include congenital and acquired stenosis.
  • congenital stenosis is mostly caused by congenital heart disease with pulmonary circulatory dysplasia, such as tetralogy of Fallot, pulmonary atresia, etc.
  • acquired stenosis is mostly caused by surgery, such as postoperative anastomotic stenosis.
  • the physiological characteristics of the pulmonary artery are: low pressure, thin blood vessel wall, large size, large shrinkage and large diameter, and venous blood inside.
  • the tissue structure at the onset of stenosis is mostly caused by postoperative scars or hyperplasia, which is more difficult to expand than normal vascular tissue.
  • the diameter of the pulmonary artery will be relatively large, and there may be a large difference between the proximal and distal diameters.
  • the stent After the stent is expanded, it needs to be cylindrical or tapered to ensure that the stent adheres to the wall to conform to the anatomical structure of the pulmonary artery without irritating the blood vessel wall excessively.
  • pulmonary artery stents that expands according to the anatomy of the pulmonary artery.
  • the pulmonary artery end of the infant’s pulmonary artery is small and tortuous, and it is relatively difficult for the stent to be pushed to the target location.
  • the growth and development of the infant’s body changes greatly, and the blood vessels themselves will continue to grow and grow after treatment. Passive stenosis at the stent places higher requirements on the design of the pulmonary artery stent.
  • the main purpose of the present application is to provide an infant pulmonary artery stent suitable for infants and young children, which has good flexibility and can meet the interventional treatment needs of infants and young children.
  • Another objective of the present application is to provide an infant pulmonary artery stent suitable for infants and young children, which has good flexibility and a small outer diameter after being pressed.
  • the present application provides a pulmonary artery stent for infants.
  • the stent is a balloon-expandable type.
  • the stent includes a plurality of mesh-shaped unit sections and a connecting rod.
  • the unit section includes a plurality of end-to-end joint rods.
  • the joints are encircled in a ring shape; the connecting rods are connected to adjacent unit sections, the number of joints in each unit section is 12 to 30, the connection between the two joints is a circular arc transition, and the connecting rods are along the unit
  • the joints are evenly distributed in the circumferential direction, at least one connecting part of the connecting rod is arranged at least one of the arc transitions, and the connecting part of the adjacent unit node is connected to the connecting rod correspondingly.
  • the bracket includes two connecting rods with different circumferential inclination directions.
  • the stent includes two connecting rods with different circumferential inclination directions, and the connecting rods of the two directions are staggered along the axial direction of the stent.
  • the connecting rod is an S-shaped, Z-shaped or ⁇ -shaped connecting rod.
  • the number of joint rods in each unit section is 18-24.
  • the two ends of the bracket are end unit sections, and the middle unit section is between the two end unit sections.
  • the radius of the arc transition of the end unit nodes at both ends of the bracket is greater than or equal to the radius of the arc transition of the middle unit node.
  • the connecting rods between the two end unit sections and the middle unit section have different circumferential inclination directions.
  • the length of a single link in the middle unit section is 2-5 mm, and the length of a single link in the end unit section is equal to or less than the length of a single link in the middle unit section.
  • the rod width of each of the middle unit sections is greater than or equal to the rod width of each of the end unit sections.
  • each of the joints is set at the starting point of the arc transition, or each of the joints is set at the middle of the arc transition.
  • the embodiment of the present application proposes to control the number of joint rods in each unit section of the bracket between 12 and 30, while reducing the number of connecting rods, and configure the bracket to be arranged with at least 2 joint rods.
  • the bracket is designed as an open-loop structure.
  • the open-loop structure is to provide a connecting rod with at least one arc transition between two adjacent unit sections. In this way, the stent in the holding state will have better flexibility.
  • the S connection structure between every two layers can be forward or reverse "S” connection, reverse "S", one positive and one reverse “S” connection makes the stent in the axial direction
  • the two spacing units will not be twisted or shifted in the axial direction due to the same force direction, making some positions too large.
  • the stent is made of thin-walled tubing, which has a smaller outer diameter after being crimped, making it easier to pass through small and tortuous blood vessels.
  • FIG. 1 is a schematic diagram of the structure of an infant pulmonary artery stent after the first expansion according to an embodiment of the application.
  • Fig. 2 is a schematic diagram of an enlarged structure at A in Fig. 1.
  • Fig. 3 is a schematic structural diagram of a pulmonary artery stent for infants provided by an embodiment of the application after the second expansion.
  • Fig. 4 is a schematic diagram of an enlarged structure at B in Fig. 1.
  • FIG. 5 is a partial structural schematic diagram 1 of an infant pulmonary artery stent deployed state according to an embodiment of the application.
  • Fig. 6 is a second partial structural schematic diagram of an infant pulmonary artery stent in a deployed state according to an embodiment of the application.
  • FIG. 7 is a third partial structural schematic diagram of an infant pulmonary artery stent in a deployed state according to an embodiment of the present application.
  • the embodiments of this application propose to control the number of rods in each unit section of the stent to 12 to 30 under the premise that the diameter of the raw material does not need to be changed.
  • the connecting rod is configured to have at least one arc transition for setting.
  • the stent is designed as an open-loop structure. At the same time, because the open-loop structure can be used to achieve post-expansion, the S-connecting structure between every two layers can be forward or reverse.
  • the stent is made of thin-walled tubing.
  • the thickness of the thin-walled tubing is selected to be between 0.2 and 0.4mm.
  • the stent prepared according to this has a smaller outer diameter after pressing, which is more convenient Through small tortuous blood vessels.
  • FIG. 1 is a schematic structural diagram of an infant pulmonary artery stent provided by an embodiment of the application after the first expansion
  • Fig. 2 is an enlarged schematic diagram of the structure at A in Fig. 1
  • Fig. 3 is a infant pulmonary artery stent provided by an embodiment of the application
  • FIG. 4 is the schematic diagram of the enlarged structure at B in FIG. 1.
  • the stent 10 mainly includes a plurality of mesh-shaped unit sections and connecting rods 16.
  • the two ends of the stent 10 can be end unit sections 11, and the two ends Between the unit sections 11 are a plurality of middle unit sections 12.
  • Each unit section includes a plurality of joint rods 13 that are connected end to end, and the plurality of joint rods 13 are connected to each other and form a ring around the axis of the bracket 10.
  • the connecting rod 16 is connected between the adjacent unit sections.
  • the number of the joint rods 16 in each unit section is selected to control from 12 to 30, and the connection between the two joint rods 13 is a circular arc transition 14, and the connecting rod 16 runs along the unit section. It is evenly distributed in the circumferential direction.
  • it is set that at least one arc transition 14 is arranged at a connection point of a connecting rod 16, and the connecting points on adjacent unit sections are correspondingly connected by the connecting rod 16.
  • the stent in this embodiment can also be expanded twice.
  • the expansion angle between the two rods 13 in Figures 1 and 2 is 30 degrees.
  • the left and right expand twice to the expansion angle of about 90 degrees as shown in Figs. 3 and 4 (the angle ⁇ in Fig. 4).
  • the diameter of the stent can be expanded multiple times, which also meets the growth needs of infants and young children after the stent is implanted.
  • the material of the stent 10 can be selected from one of stainless steel, cobalt-based alloy, platinum-iridium alloy, nickel-titanium alloy, or magnesium-based alloy.
  • the connecting rod 16 can be selected in an applicable connecting rod form such as S-type, Z-type, or ⁇ -type.
  • the rod width can be selected to increase the support strength of the stent, which is suitable for older infants and young children.
  • the number of bands of the joint rod 13 in the end unit section 11 and the middle unit section 12 can be selected from 12 to 30 knots, preferably 18 knots or 24 knots, and the number of bands of the joint rod 13 can be increased.
  • the diameter of the stent 10 after expansion is increased.
  • the connecting rods 16 are selected to be uniformly distributed along a circle of the unit section, and the number can be 2-15. The less the number of connecting rods 16 is, the better the flexibility of the bracket 10 is.
  • the connecting rods 16 can be selected as 6, and a connecting rod 16 is arranged at a pair of bands 13 at intervals along the unit section. This design is suitable for maintaining the bracket. Based on the flexibility, the stent can obtain higher support strength, which is suitable for older infants and young children.
  • the number of connecting rods 16 is preferably 3, and one connecting rod 16 is arranged at two pairs of bands 13 along the unit section at intervals. This design makes the bracket 10 better The flexibility, while maintaining the appropriate radial support strength, makes the stent suitable for younger infants and young children.
  • the outer radius of the middle joint rod 13 of the end unit section 11 is selected to be 0.2 to 0.5 mm, and the rod width of the middle joint rod 13 of the end unit section is selected to be 0.1 to 0.3 mm.
  • the outer radius of the middle section rod 13 of the middle unit section 12 is selected to be 0.2 to 0.4 mm, and the rod width range of the middle section rod 13 of the middle section 12 may be selected to be 0.1 to 0.4 mm.
  • the angle, outer radius, and rod width of the rod 13 of the end unit section 11 may be the same as or different from those of the rod 13 of the middle unit section 12.
  • every two apexes of the rods can obtain a uniform expansion angle, and the stent 10 can obtain a uniform supporting force, which is more suitable for pulmonary arteries with equal diameters at the distal and proximal ends of the stenosis.
  • the angle of the joint rod 13 of the end unit section 11 is smaller than that of the joint rod 13 of the middle unit section 12, and the outer radius of the joint rod 13 of the end unit section 11 is greater than or equal to that of the middle unit section 12.
  • the joint rod 13, the rod width of the joint rod 13 of the end unit section 11 is smaller than the joint rod 13 of the middle unit section 12, and the supporting force of the end part is smaller than the supporting force of the middle part during expansion.
  • This type of stent is suitable for pulmonary arteries whose distal and proximal diameters are not equal.
  • each section rod 13 in the bracket 10 is selected to be 0.2-0.3 mm, preferably 0.25 mm.
  • the wall thickness of the stent can be selected from 0.2 to 0.4 mm, preferably 0.3 mm.
  • the stent 10 can have a smaller outer diameter after being crimped, and the outer diameter after crimping ranges from 2.4 mm to 4.1 mm, and the smallest outer diameter after crimping is 2.4 mm, to facilitate the delivery of the stent in the human body, and at the same time, it is easy to make the surface of the stent 10 more quickly endothelialized, which is more conducive to the implantation of the stent. This is especially true during the stent delivery process, which can provide an effect beyond expectation, and the delivery speed of the stent can be greatly improved compared to the existing stent.
  • the length of the joint rod 13 of the middle unit section 12 can be selected to be 2-5 mm.
  • the length of the joint rod 13 of the end unit section 11 may be the same as that of the joint rod 13 of the middle unit section 12, or may be smaller than the joint rod 13 of the middle unit section 12.
  • the stent When the length of the joint rod 13 of the end unit section 11 is less than the length of the joint rod 13 of the middle unit section 12, after the stent is expanded, the radial support force provided by the end of the stent is greater than the joint rod 13 of the middle unit section 12. At the same time, when the end When the length of the joint rod 13 of the lower unit section 11 is smaller than that of the joint rod 13 of the middle unit section 12, the stent can have a smaller contour effect (flare effect), which makes the stent suitable for delivery in infants and young children.
  • Fig. 5 is a partial structural schematic diagram 1 of the expanded state of the infant pulmonary artery stent provided by an embodiment of the application, showing that the left connection point of the connecting rod 16 is in the middle of the arc transition 14, and the right connection point of the connecting rod 16 is in the circle Arc transition 14 in the middle.
  • Fig. 6 is a partial structural diagram 2 of the expanded state of the infant pulmonary artery stent provided by an embodiment of the application, showing that the left connection point of the connecting rod 16 is at the upper starting point of the arc transition 14, and the right connection point of the connecting rod 16 Start at the lower side of the arc transition 14.
  • Fig. 5 is a partial structural schematic diagram 1 of the expanded state of the infant pulmonary artery stent provided by an embodiment of the application, showing that the left connection point of the connecting rod 16 is in the middle of the arc transition 14, and the right connection point of the connecting rod 16 is in the circle Arc transition 14 in the middle.
  • Fig. 6 is a partial structural diagram 2 of the expanded state of the
  • FIG. 7 is a partial structural schematic diagram 3 of the expanded state of a pulmonary artery stent for infants provided by the embodiment of the present application, showing that the left connection point of the connecting rod 16 is at the lower starting point of the arc transition 14, and the right connection point of the connecting rod 16 is at The upper starting point of the arc transition 14.
  • the starting point of the connecting rod 16 may be located on the arc transition 14 of the joint rod 13 at an angle of -80 to 80° with respect to the X axis (parallel to the central axis of the bracket 10), and the preferred starting point of the connecting rod 16 may be located at On a joint rod with an arc angle of 54° to the X axis, in other words, the angle formed by the line between the center of the arc of the joint rod and the starting point of the connecting rod 16 and the X axis is in the range of -80 to 80° , Preferably in the range of -54° to 54°.
  • the distance between the center of the S-shaped connecting rod 16 and the center of the pitch rod along the X axis is 0.3 to 0.6 mm, preferably 0.5 mm, and the distance along the Y axis may be 0.3 to 0.6 mm, preferably 0.5 mm.
  • the connecting rod 16 may start on the arc transition 14 of the joint rod 13 at an arc angle of 0° to the X axis, as shown in Fig. 5; the connecting rod may also be located on the joint rod at an arc angle of 54° or -54° to the X axis.
  • the connecting rods 16 in the above multiple configurations can be staggered along the axial direction of the stent 10, so that the stent can be deformed uniformly during expansion or crimping.

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

Abstract

L'invention concerne une endoprothèse (10) pour artère pulmonaire de nourrisson, l'endoprothèse (10) étant du type à dilatation par ballonnet, l'endoprothèse (10) comprenant une pluralité de sections unitaires (11, 12) en forme de tube maillé et des tiges de liaison (16), chacune des sections unitaires (11, 12) comprenant une pluralité de tiges de section (13) reliées bout à bout, les sections unitaires (11, 12) définissant une forme annulaire, les tiges de liaison (16) étant reliées aux sections unitaires adjacentes (11, 12), le nombre de tiges de section (13) dans chacune des sections unitaires (11, 12) étant compris entre 12 et 30, le joint entre deux tiges de section (13) constituant une partie de transition en arc de cercle (14), les tiges de liaison (16) étant réparties uniformément dans la direction circonférentielle des sections unitaires (11, 12), le joint d'une tige de liaison (16) étant disposé de manière espacée par au moins une partie de transition en arc de cercle (14), et les joints entre les sections unitaires adjacentes (11, 12) étant reliés au moyen des tiges de liaison (16). Une bonne flexibilité est obtenue, et l'exigence d'intervention thérapeutique d'un patient en bas âge peut être satisfaite.
PCT/CN2020/137146 2019-12-17 2020-12-17 Endoprothèse pour artère pulmonaire de nourrisson WO2021121307A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201911305135.8A CN112972083B (zh) 2019-12-17 2019-12-17 幼儿肺动脉支架
CN201911305135.8 2019-12-17

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CN116115286A (zh) * 2022-03-14 2023-05-16 杭州亿科医疗科技有限公司 一种贴壁性好的血管支架
CN116115286B (zh) * 2022-03-14 2024-06-07 杭州亿科医疗科技有限公司 一种贴壁性好的血管支架

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116115286A (zh) * 2022-03-14 2023-05-16 杭州亿科医疗科技有限公司 一种贴壁性好的血管支架
CN116115286B (zh) * 2022-03-14 2024-06-07 杭州亿科医疗科技有限公司 一种贴壁性好的血管支架

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