WO2022105401A1 - Endoprothèse médicale - Google Patents

Endoprothèse médicale Download PDF

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Publication number
WO2022105401A1
WO2022105401A1 PCT/CN2021/118624 CN2021118624W WO2022105401A1 WO 2022105401 A1 WO2022105401 A1 WO 2022105401A1 CN 2021118624 W CN2021118624 W CN 2021118624W WO 2022105401 A1 WO2022105401 A1 WO 2022105401A1
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WO
WIPO (PCT)
Prior art keywords
wave
medical stent
connecting rod
sub
stent
Prior art date
Application number
PCT/CN2021/118624
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English (en)
Chinese (zh)
Inventor
张广建
刘梦钦
姬庆如
杨波
Original Assignee
上海鸿脉医疗科技有限公司
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Publication of WO2022105401A1 publication Critical patent/WO2022105401A1/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
    • A61F2/02—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
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2002/91566—Adjacent bands being connected to each other connected trough to trough
    • 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

  • the invention relates to the technical field of medical devices, in particular to a medical stent.
  • Cardiovascular disease has become the number one killer of human death.
  • vascular prostheses such as stents have been widely used in the treatment of various vascular access abnormalities in the human body, such as hemangioma, dissection, embolism, stenosis and other cardiovascular diseases.
  • ePTFE (expanded polytetrafluoroethylene) covered stents have been widely used in the field of implantable medical devices due to their excellent biocompatibility and super-slip properties.
  • the indications of ePTFE covered stents include peripheral vascular embolization, aortic and branch dissection, aortic and branch true aneurysm, aortic and branch pseudoaneurysm, aortic and branch penetrating ulcer, etc.
  • the use of stent implantation in the treatment of cardiovascular disease greatly reduces the operative mortality and postoperative complications, reduces the surgical trauma and facilitates the postoperative recovery of patients.
  • the treatment mechanism of stent implantation is to release the stent-graft into the lesion through a delivery sheath, and the stent expands at the lesion to open the blocked blood vessel, or isolate the hemangioma and blood to eliminate the aneurysm rupture and hemorrhage. Risk of death, or reduce the compression of the tumor on surrounding tissues and organs.
  • stent products such as Gore Viabahn, Bard Fluency, Aegis, Ankura and the like.
  • the flexibility of stents has always been the research focus of stent products in clinical applications, especially in the field of peripheral blood vessels.
  • the so-called "flexibility" means that the shape of the stent can adapt to the shape of the blood vessel and change with the change of the shape of the blood vessel.
  • the stent with good flexibility can have good adherence to the blood vessel when implanted in the lesion site, and no space is left between the outer wall of the stent and the blood vessel.
  • most of the lesions are vascular embolism, and the embolized blood vessel has a small diameter and a tortuous anatomical shape, so the flexibility of the stent is relatively high.
  • Laser-cut stents have flexible designability.
  • the stent In order to maintain the flexibility of the stent, when cutting the tube to form the stent, the stent needs to be designed as an open-loop structure, but the stent with the open-loop structure is ejected from the delivery sheath. When released, it is easy to be compressed and deformed, resulting in shortening of the stent and folds of the covering, which affects the hemodynamics passing through the lumen of the stent, and generates eddy currents and other phenomena. However, changes in hemodynamics can easily aggravate the generation of thrombus inside the stent, resulting in the problem of in-stent restenosis.
  • the purpose of the present invention is to provide a medical stent, which aims to change the structure of the medical stent, so that when it is in a compressed state and is subjected to axial pressure, it can maintain the axial length, and avoid problems such as shortening and coating folds, Improve treatment effect.
  • a medical stent provided by the present invention includes a stent body, and the stent body includes a plurality of wave rings and connecting rods, and the plurality of wave rings are arranged in sequence along the axial direction of the medical stent, and the plurality of wave rings are arranged in sequence along the axial direction of the medical stent. each of the wave circles is connected by the connecting rod;
  • the medical stent is configured such that when the medical stent is at least partially in a compressed state and is subjected to axial pressure, two adjacent wave circles abut against each other or have a predetermined distance, so as not to reduce the strength of the medical stent. Axial length.
  • the wave ring includes wave crests and wave troughs alternately arranged along the circumferential direction of the medical stent, and on the same wave ring, at least one wave crest and/or space between two adjacent connecting rods. or at least one trough.
  • the connecting rod is a linear configuration extending along the axial direction of the medical stent, and the opposite ends of the connecting rod are respectively connected with the wave crests of two adjacent wave circles, or with adjacent wave crests. the trough connection of the two said wave circles;
  • the edge line of the convex side of the wave crest and the edge line of the convex side of the trough both extend along the circumferential direction of the medical stent, so that when the medical stent is at least partially in the compressed state and is subjected to axial pressure, Two adjacent wave circles abut against each other.
  • the dimension of the edge line of the convex side of the wave crest and the edge line of the convex side of the wave trough in the circumferential direction of the medical stent is 0.1 mm-5 mm.
  • the connecting rod includes a first sub-connecting rod
  • the first sub-connecting rod has a Z-shaped structure, and includes a first rod body, a second rod body and a third rod body connected in sequence, the first rod body and The third rod body extends along the axial direction of the medical stent, and the second rod body extends along the circumferential direction of the medical stent; the concave side of the wave crest of one of the adjacent two wave circles Connected with the first rod body, and the concave side of the wave trough of the other wave ring is connected with the third rod body, so that when the medical stent is at least partially in the compressed state and subjected to axial pressure, the adjacent two Each of the wave circles abuts against both sides of the second rod body to have the predetermined distance; and/or,
  • the connecting rod includes a second sub-connecting rod, the second sub-connecting rod extending along the circumferential direction of the medical stent; the convex side of the wave crest of one of the adjacent two wave circles is connected to the other.
  • the convex side of the wave trough of one wave ring is respectively connected with both ends of the second sub-connecting rod, so that when the medical stent is at least partially in the compressed state and is subjected to axial pressure, two adjacent The wave circles are respectively abutted on both sides of the second sub-connecting rod to have the predetermined distance.
  • the connecting rod includes a first sub-connecting rod, the first sub-connecting rod has a Z-shaped structure, and includes a first rod body, a second rod body and a third rod body that are connected in sequence, the first rod body and the third rod body
  • the rod body extends along the axial direction of the medical stent, and the second rod body extends along the circumferential direction of the medical stent; the concave side of the wave crest of one of the adjacent two wave circles and the first One rod body is connected, and the concave side of the wave valley of the other wave ring is connected with the third rod body, so that when the medical stent is at least partially in the compressed state and is subjected to axial pressure, two adjacent wave
  • the rings are respectively abutted on both sides of the second rod body to have the predetermined spacing; and/or,
  • the connecting rod includes a second sub-connecting rod, the second sub-connecting rod has a Z-shaped structure, and includes a fourth rod body, a fifth rod body and a sixth rod body connected in sequence, wherein the fourth rod body and the first rod body are connected.
  • the six-rod body extends along the circumferential direction of the medical stent, and the fifth rod body extends along the axial direction of the medical stent;
  • the fourth rod body is connected, and the convex side of the wave crest of the other wave ring is connected with the sixth rod body, so that when the medical stent is at least partially in the compressed state and is subjected to axial pressure, the one wave
  • the loop abuts against the proximal end side of the fourth rod body, while the other wave loop abuts against the distal end side of the sixth rod body to have the predetermined spacing.
  • the connecting rod includes the first sub-connecting rod and the second sub-connecting rod
  • the first sub-connecting rod and the second sub-connecting rod are respectively located in the same wave circle.
  • the first sub-connecting rods and the second sub-connecting rods are alternately arranged in the circumferential direction of the medical stent.
  • all the first sub-connecting rods are arranged in a plurality of first helical structures around the axis of the medical stent, while all the second sub-connecting rods are arranged in multiples around the axis of the medical stent.
  • Second helical structure Second helical structure.
  • first helical structure and the second helical structure are arranged at equal intervals in the circumferential direction of the medical stent.
  • the number of the wave crests of each of the wave circles is 4-20; and/or,
  • the number of said connecting rods is 2-10; and/or,
  • the axial length of the wave ring is 1mm-20mm.
  • the wave ring includes a plurality of bracket edges connected end to end in sequence, and two adjacent bracket edges are connected at an angle to form the wave crest or the wave trough;
  • the angle of the formed included angle is 10°-80°.
  • the medical stent further comprises an outer covering film and/or an inner covering film, the outer covering film is arranged on the outer surface of the stent body, and the inner covering film is arranged on the inner surface of the stent body superior.
  • the present invention also provides another medical stent, comprising a stent body, the stent body including a plurality of wave rings connected in sequence along the axial direction of the medical stent, and the wave rings include The crests and troughs of the stent are alternately arranged in the circumferential direction, and the ends of the crests and the troughs extend along the circumferential direction of the medical stent.
  • the support body further includes a connecting rod, and a plurality of the wave circles are connected by the connecting rod; the opposite ends of the connecting rod are respectively connected with the wave crests of two adjacent wave circles, or Connect with the valleys of two adjacent wave circles.
  • the present invention also provides another medical stent, comprising a stent body, the stent body including a plurality of wave rings and connecting rods, and the plurality of wave rings are arranged in sequence along the axial direction of the medical stent, And a plurality of the wave circles are connected by the connecting rod; the opposite ends of the connecting rod are respectively connected with the wave crests and the wave troughs of the adjacent two wave circles;
  • the connecting rod includes a first sub-connecting rod and/ Or the second sub-connecting rod, the first sub-connecting rod is a Z-shaped structure, the second sub-connecting rod extends along the circumferential direction of the medical stent and/or the second sub-connecting rod is a Z-shaped structure.
  • opposite ends of the first sub-connecting rod are respectively connected to the concave side of the wave crest and the concave side of the wave trough of two adjacent wave circles.
  • opposite ends of the second sub-connecting rod are respectively connected to the convex side of the wave crest and the convex side of the wave trough of two adjacent wave circles.
  • first sub-connecting rod and the second sub-connecting rod are located on both axial sides of the same wave ring, and the first sub-connecting rod and the second sub-connecting rod are on
  • the medical stents are alternately arranged in the circumferential direction.
  • the medical stent of the present invention has the following advantages:
  • the medical stent includes a stent body, the stent body includes a plurality of wave coils and a connecting rod, the plurality of wave coils are arranged in sequence along the axial direction of the medical stent, and the plurality of the wave coils pass through the connecting rod connecting; the medical stent is configured such that when the medical stent is at least partially in a compressed state and is subjected to axial pressure, two adjacent wave circles abut each other or have a predetermined distance, so as not to reduce the medical stent
  • the axial length of the stent can overcome the shortening of the medical stent, avoid the hemodynamic changes caused by the folds of the membrane, and improve the treatment effect.
  • FIG. 1 is a schematic structural diagram of a medical stent provided by the present invention according to an embodiment
  • Fig. 2 is a radial cross-sectional view of the medical stent shown in Fig. 1;
  • FIG. 3 is an enlarged schematic view of the medical stent shown in FIG. 1;
  • FIG. 4 is a schematic diagram of a medical stent provided by the present invention when it is compressed in a delivery sheath according to an embodiment
  • FIG. 5 is a schematic diagram of the medical stent provided by the present invention according to an embodiment when the medical stent is ejected and released in the delivery sheath;
  • FIG. 6 is a schematic structural diagram of a medical stent provided according to another embodiment of the present invention.
  • Figure 7 is an enlarged schematic view of the medical stent shown in Figure 6;
  • FIG. 8 is a schematic diagram of a medical stent provided by the present invention according to another embodiment when it is compressed in a delivery sheath;
  • Fig. 9 is a schematic diagram of the medical stent provided by the present invention according to another embodiment when the medical stent is ejected and released in the delivery sheath;
  • FIG. 10 is a schematic diagram of the medical stent provided by the present invention when the stent body is connected to the inner covering film and the outer covering film.
  • each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately.
  • One or all of the technical features of the .
  • those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a,” “an,” and “the” include plural referents, and the review form “plurality” includes two or more referents unless the content clearly dictates otherwise.
  • the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise, and the terms “installed”, “connected”, “connected” shall be To be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
  • the core idea of the present invention is to provide a medical stent, the medical stent includes a stent body, the stent body includes a plurality of wave coils and connecting rods, and the plurality of wave coils are arranged in sequence along the axial direction of the medical stent, And a plurality of the wave circles are connected by the connecting rod.
  • the medical stent is configured such that when the medical stent is at least partially in a compressed state and is subjected to axial pressure, two adjacent wave circles abut against each other or have a predetermined distance, so as not to reduce the axis of the medical stent It can overcome the problems of shortening of the medical stent and the folds of the covering, thereby avoiding the dynamic changes of the blood flow through the lumen of the medical stent, which may cause adverse consequences such as thrombosis and in-stent restenosis, and improve the treatment efficiency. Effect.
  • the medical stent includes a stent body 1000 , and the stent body 1000 includes a plurality of wave coils 1100 and connecting rods 1200 .
  • the stents are arranged in sequence in the axial direction, and a plurality of the wave coils 1100 are connected by the connecting rods 1200 .
  • the medical stent is configured such that when the medical stent is at least partially in a compressed state and is subjected to axial pressure, two adjacent wave rings 1100 abut against each other or have a predetermined distance, so as not to reduce the strength of the medical stent. Axial length.
  • proximal end refers to the relative orientation, relative position, and orientation of elements or actions relative to each other from the perspective of the physician using the medical device, although “proximal end” and “distal end” are not The limiting, but “proximal” end generally refers to the end of the medical device that is closest to the physician during normal operation, while “distal” generally refers to the end that first enters the patient's body. Taking the orientations shown in Fig. 1, Fig. 3, Fig. 5, and Fig. 6 as an example, the proximal end refers to the left end, and the distal end refers to the right end.
  • the medical stent further includes a coating, and the material of the coating includes but is not limited to ultra-high molecular weight polyethylene (UHMWPE), polyurethane (PU), expanded polytetrafluoroethylene (ePTFE) or at least one of polytetrafluoroethylene (PTFE).
  • UHMWPE ultra-high molecular weight polyethylene
  • PU polyurethane
  • ePTFE expanded polytetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • the covering film is provided at least on the outer surface or the inner surface of the stent body 1000, preferably on the outer surface and the inner surface at the same time, that is, the covering film includes both the outer covering film 1310 and the inner covering film 1320 .
  • the medical stent includes the outer covering film 1310 and the inner covering film 1320 as an example for description.
  • two adjacent wave rings 1100 abut against each other or are spaced at a predetermined distance, so that Overcome the shortening problem of the medical stent when it is ejected and released from the delivery sheath, thereby avoiding wrinkles on the outer covering film 1310 and the inner covering film 1320, thereby preventing blood from flowing through the medical stent.
  • Thrombosis and in-stent restenosis are caused by hemodynamic changes in the cavity.
  • the wave ring 1100 includes wave crests 1110 and wave troughs 1120 alternately arranged along the circumference of the medical stent. Specifically, the wave ring 1100 includes a plurality of bracket edges 1101 connected end to end in sequence, and two adjacent bracket edges 1101 are connected at an angle to form the wave crest 1110 and the wave trough 1120 .
  • the convex side of the wave crest 1110 faces the proximal end of the medical stent
  • the concave side faces the distal end of the medical stent
  • the convex side of the wave trough 1120 faces all the The distal end of the medical stent and the concave side faces the proximal end of the medical stent.
  • at least one wave crest 1110 and/or one wave trough 1120 is spaced between two adjacent connecting rods 1200, so as to maintain the flexibility of the medical stent.
  • the three wave coils 1100 will be sequentially arranged along the axial direction of the medical stent herein. They are respectively referred to as the first wave circle 1100a, the second wave circle 1100b and the third wave circle 1100c, wherein the first wave circle 1100a is adjacent to the second wave circle 1100b, and the second wave circle 1100b is adjacent to the second wave circle 1100b.
  • the third wave circle 1100c is adjacent to each other.
  • the connecting rod 1200 is a linear configuration extending along the axial direction of the medical stent.
  • the opposite ends of a part of the connecting rods 1200 are respectively connected with the concave side of the wave crest 1110 of the first wave ring 1100a and the convex side of the wave crest 1110 of the second wave ring 1100b, and the other part of the connecting rod 1200 The opposite ends of are connected to the convex side of the trough 1120 of the second wave ring 1100b and the concave side of the trough 1120 of the third wave ring 1100c, respectively.
  • the ends of the wave crest 1110 and the wave trough 1120 of the wave ring 1100 extend along the circumferential direction of the medical stent.
  • the end of the wave crest 1110 refers to the convex side of the wave crest 1110 , that is, the edge line of the convex side of the wave crest 1110 of the wave ring 1100 extends along the circumferential direction of the medical stent .
  • the end of the wave trough 1120 refers to the convex side of the wave trough 1120, so the edge line of the convex side of the wave trough 1120 also extends along the circumferential direction of the medical stent.
  • the edge line of the convex side of the wave crest 1110 and the edge line of the convex side of the wave trough 1120 are both straight.
  • the “deployed state” refers to the state when the medical stent is cut open along the axis of the medical stent, and the medical stent is stretched into a planar structure.
  • Fig. 4 shows a schematic diagram of the medical stent being compressed in the delivery sheath 1
  • Fig. 5 shows that in the output sheath 1, an ejector rod 2 exerts an axial direction on the proximal end of the medical stent
  • the straight edge line of the trough 1120 of the first wave circle 1100 a and the straight edge line of the wave crest 1110 of the second wave circle 1100 b abut against each other, so that The troughs 1120 of the first wave circle 1100a cannot enter the gap between the two adjacent wave crests 1110 of the second wave circle 1110b.
  • the wave crests 1110 of the second wave circle 1100b cannot enter.
  • the gap between two adjacent wave valleys 1120 of the first wave ring 1100a is used to maintain the axial length of the medical stent.
  • the straight edge line of the trough 1120 of the second wave circle 1100b abuts against the straight edge line of the wave crest 1110 of the third wave circle 1100c.
  • the dimension of the edge line of the convex side of the wave crest 1110 in the circumferential direction of the medical stent is 0.1mm-5mm.
  • the dimension of the edge line of the convex side of the wave trough 1120 in the circumferential direction of the medical stent is also 0.1 mm-5 mm. Set according to actual needs.
  • two adjacent wave rings 1100 abut on opposite sides of the connecting rod 1200, so that adjacent The two wave coils 1100 maintain the predetermined distance to overcome the shortening.
  • the connecting rod 1200 includes a first sub-connecting rod 1210 and a second sub-connecting rod 1220 .
  • the first sub-connecting rod has a Z-shaped structure, and includes a first rod body 1211 , a second rod body 1212 and a third rod body 1213 that are connected in sequence.
  • the first rod body 1211 and the third rod body 1213 extend along the axial direction of the medical stent
  • the second rod body 1212 extends along the circumferential direction of the medical stent.
  • the second sub-connecting rod 1220 extends along the circumferential direction of the medical bracket.
  • both the first sub-connecting rod 1210 and the second sub-connecting rod 1220 are provided on the same wave ring 1100, and the first sub-connecting rod 1210 and all the The second sub-connecting rods 1220 are located on both sides of the wave ring 1100 in the axial direction, and the first sub-connecting rods 1210 and the second sub-connecting rods 1220 are alternately arranged in the circumferential direction of the medical stent.
  • the first wave ring 1100a and the second wave ring 1100b are connected by the first sub-connecting rod 1210.
  • the first wave ring 1100b is The concave side of the wave crest 1110 of the wave ring 1100a is connected with the first rod body 1211 of the first sub-connecting rod 1210 , and the concave side of the wave trough 1120 of the second wave ring 1100b is connected with the first sub-connecting rod 1210 .
  • the third rod body 1213 is connected.
  • the convex side of the wave trough 1120 of the second wave ring 1100b is connected with the convex side of the wave crest 1110 of the third wave ring 1100c through the second sub-connecting rod 1220 .
  • Fig. 8 shows a schematic diagram of the medical stent provided in this embodiment being compressed in the delivery sheath 1
  • Fig. 9 shows that in the output sheath 1, an ejector rod 2 is in the medical stent
  • the first wave ring 1100a and the second wave ring 1100b respectively abut on opposite sides of the second rod body 1212 of the first sub-connecting rod 1210, so that the first wave ring 1100a
  • the predetermined distance is the dimension of the second rod body 1212 in the axial direction of the medical stent.
  • the second wave ring 1100b and the third wave ring 1100c abut against opposite sides of the second sub-connecting rod 1220, respectively, to have the predetermined distance.
  • the predetermined distance is the first distance.
  • the widths of the first sub-connecting rod 1210 and the second sub-connecting rod 1220 may be 0.1 mm-2 mm. It can be understood that, for the first sub-connecting rod 1210, the so-called “width” refers to the size of the first rod body 1211 and the third rod body 1213 in the circumferential direction of the medical stent, and the second The size of the rod body 1212 in the axial direction of the medical stent. Similarly, for the second sub-connecting rod 1220, the so-called “width” refers to the dimension of the second sub-connecting rod 1220 in the axial direction of the medical stent.
  • all the first sub-connecting rods 1210 are arranged in a plurality of first helical structures around the axis of the medical stent, while all the second sub-connecting rods 1120 are arranged around the medical stent
  • the axes of the medical stents are arranged into a plurality of second helical structures, so that the first helical structures and the second helical structures are alternately arranged in the circumferential direction of the medical stent.
  • the first helical structure and the second helical structure are arranged at equal intervals in the circumferential direction of the medical stent. With this arrangement, the medical stent has both flexibility and shortening resistance, and has a good use effect.
  • the connecting rod 1200 does not necessarily have the first sub-connecting rod 1210 and the second sub-connecting rod 1220 at the same time.
  • the connecting rod 1200 may only include the first sub-connecting rod 1210, or the connecting rod 1200 may only include the second sub-connecting rod 1220, which can reduce shortening , the purpose of improving the therapeutic effect.
  • the second sub-connecting rod may also have a Z-shaped structure, and include a fourth rod body, a fifth rod body and a sixth rod body connected in sequence, wherein the fourth rod body and the sixth rod body The rod body extends along the circumferential direction of the medical support, and the fifth rod body extends along the axial direction of the medical support.
  • connection of the fourth rod body of the second sub-connecting rod with the convex side of the trough of the second wave ring, and the connection of the sixth rod body with the convex side of the wave crest of the third wave ring as an example,
  • the convex side of the trough of the second wave ring abuts on the proximal end side of the fourth rod body
  • the third The convex side of the wave crest of the wave ring abuts on the distal side of the sixth rod body (not shown in the figure).
  • one of the medical stents includes the first sub-connecting rod and the second sub-connecting rod of two structures at the same time. That is, in one of the medical stents, a part of the second sub-connecting rods extends along the circumferential direction of the medical stent, and another part of the second sub-connecting rods has a Z-shaped structure.
  • the medical stent includes the stent body 1000 , the outer covering film 1310 and the inner covering film 1320 .
  • the stent body 1000 is obtained by laser engraving the tube.
  • the medical stent includes but is not limited to a self-expanding stent.
  • the material of the tube can be a shape memory alloy or a material with high resilience, such as titanium-based alloy, cobalt-chromium alloy, stainless steel, etc.
  • the titanium-based alloy can be selected from nickel-titanium alloys.
  • the outer covering film 1310 and the inner covering film 1320 are provided on the stent body 1000 .
  • the coating tool 10 is selected according to the diameter of the stent body 1000 , the outer surface of the coating tool 10 is coated with a layer of isolation film 20 , and then the inner coating 1320 is set on the outer surface of the separator 20 .
  • the stent body 1000 is sheathed on the outer surface of the inner coating film 1320 , and the outer coating film 1310 is coated on the outer surface of the stent body 1000 .
  • another layer of the isolation film 20 is provided on the outer surface of the outer coating film 1310 , and a heat shrinkable tube 30 is sheathed on the outer surface of the other layer of the isolation film 20 .
  • the heat shrinkable tube 30 is heated to a predetermined temperature, so that the outer covering film 1310 and the inner covering film 1320 are connected to the stent body 1000 .
  • the film coating tool 10 is in the prior art, and its structure is common knowledge, which will not be introduced here.
  • the heat shrinkable tube 30 may be heated by a heat treatment furnace.
  • each of the wave circles 1100 of the medical stent may have 4-20 of the wave crests 1110, and the number of the wave troughs 1120 corresponds to the wave crests 1110, that is, the The number of troughs 1120 is also 4-20.
  • the number of the connecting rods 1200 is 2-10.
  • the present invention does not limit the diameter of the medical stent.
  • the medical stent has a uniform diameter (including inner diameter and outer diameter) in all axial directions, that is, the medical stent is an equal diameter stent. ; In other embodiments, the medical stent has different diameters at different axial positions, that is, the medical stent is a reducing stent. According to the diameter of the diseased blood vessel, the outer diameter of the medical stent is selected within 2mm-30mm, and the wall thickness of the stent body 1000 is 0.1mm-5mm.

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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)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne une endoprothèse médicale, comprenant un corps d'endoprothèse (1000). Le corps d'endoprothèse (1000) comprend une pluralité d'anneaux ondulés (1100) et de tiges de connexion (1200), la pluralité d'anneaux ondulés (1100) étant disposés séquentiellement dans la direction axiale de l'endoprothèse médicale, et la pluralité d'anneaux ondulés (1100) étant connectés au moyen des tiges de connexion (1200). L'endoprothèse médicale est configurée de telle sorte que lorsqu'au moins une partie de l'endoprothèse médicale se trouve dans un état comprimé et est soumise à une pression axiale, tous les deux anneaux ondulés adjacents (1100) viennent en butée l'un contre l'autre ou ont une distance prédéfinie, de sorte que la longueur axiale de l'endoprothèse médicale n'est pas réduite, résolvant ainsi le problème du raccourcissement de l'endoprothèse médicale.
PCT/CN2021/118624 2020-11-19 2021-09-15 Endoprothèse médicale WO2022105401A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202011306112.1A CN114533355A (zh) 2020-11-19 2020-11-19 一种医用支架
CN202011306112.1 2020-11-19

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WO2022105401A1 true WO2022105401A1 (fr) 2022-05-27

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040230293A1 (en) * 2003-05-15 2004-11-18 Yip Philip S. Intravascular stent
CN1838927A (zh) * 2004-05-03 2006-09-27 夸利梅德创新医药产品有限公司 支架
CN2885176Y (zh) * 2006-04-20 2007-04-04 徐强 一种自扩张血管支架
CN102753119A (zh) * 2009-10-30 2012-10-24 科迪斯公司 具有改进的柔性和耐用性的脉管内装置
US20140025153A1 (en) * 2011-03-29 2014-01-23 Terumo Kabushiki Kaisha Stent and stent delivery system
CN207785318U (zh) * 2017-06-05 2018-08-31 先健科技(深圳)有限公司 医用覆膜支架
US20200237537A1 (en) * 2018-03-29 2020-07-30 Sahajanand Medical Technologies Private Limited Medical devices
CN214484745U (zh) * 2020-11-19 2021-10-26 上海鸿脉医疗科技有限公司 一种医用支架
CN113558835A (zh) * 2020-04-29 2021-10-29 微创神通医疗科技（上海）有限公司 医用支架及支架系统

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040230293A1 (en) * 2003-05-15 2004-11-18 Yip Philip S. Intravascular stent
CN1838927A (zh) * 2004-05-03 2006-09-27 夸利梅德创新医药产品有限公司 支架
CN2885176Y (zh) * 2006-04-20 2007-04-04 徐强 一种自扩张血管支架
CN102753119A (zh) * 2009-10-30 2012-10-24 科迪斯公司 具有改进的柔性和耐用性的脉管内装置
US20140025153A1 (en) * 2011-03-29 2014-01-23 Terumo Kabushiki Kaisha Stent and stent delivery system
CN207785318U (zh) * 2017-06-05 2018-08-31 先健科技(深圳)有限公司 医用覆膜支架
US20200237537A1 (en) * 2018-03-29 2020-07-30 Sahajanand Medical Technologies Private Limited Medical devices
CN113558835A (zh) * 2020-04-29 2021-10-29 微创神通医疗科技（上海）有限公司 医用支架及支架系统
CN214484745U (zh) * 2020-11-19 2021-10-26 上海鸿脉医疗科技有限公司 一种医用支架

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