CN112022461B - Be applied to vascular support of carotid artery - Google Patents

Be applied to vascular support of carotid artery Download PDF

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Publication number
CN112022461B
CN112022461B CN202010976796.XA CN202010976796A CN112022461B CN 112022461 B CN112022461 B CN 112022461B CN 202010976796 A CN202010976796 A CN 202010976796A CN 112022461 B CN112022461 B CN 112022461B
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stent
carotid artery
mesh
mesh structure
section
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CN112022461A (en
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杨耀国
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Beijing Meidi Micro Technology Co ltd
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Beijing Meidi Micro Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0008Rounded shapes, e.g. with rounded corners elliptical or oval
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017Angular shapes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017Angular shapes
    • A61F2230/0026Angular shapes trapezoidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0056W-shaped, e.g. M-shaped, sigma-shaped

Abstract

A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section and an internal carotid artery stent section; the internal carotid artery stent section is provided with a first conical structure which axially and conically extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of the carotid artery vessel of the human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular support body comprises an inner support and an outer support; the surfaces of the inner layer support and the outer layer support are respectively provided with a first mesh structure and a second mesh structure, and an overlapping area exists between the first mesh structure and the second mesh structure.

Description

Be applied to vascular support of carotid artery
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a vascular stent applied to carotid artery.
Background
Carotid artery is a large vessel that carries blood from the heart to the head, face, neck, one of the main blood supply vessels of the brain, while carotid artery stenosis is the main risk factor and etiology basis for ischemic cerebrovascular disease, 25% of which is associated with carotid artery stenosis or occlusion.
Carotid stenosis is a common disease, including carotid stenosis caused by congenital and acquired lesions, which can severely affect blood supply flow and thus cause systemic insufficiency of blood and oxygen. At present, the treatment methods of carotid stenosis mainly include medical drug treatment, carotid endarterectomy (Carotid endarterectomy, CEA) and carotid stent implantation (Carotid angioplasty and stenting, CAS). In recent 20 years, along with the gradual maturity of neuroimaging and neurointerventional technologies, the improvement of interventional materials and the improvement of operator technologies, carotid stenting has become a main treatment method for carotid stenosis due to the characteristics of safety, effectiveness, minimally invasive and remarkable curative effect.
Carotid stenting is a procedure in which a vessel is stented by treatment of a carotid stenosis so that the vessel remains in an expanded state of the original vessel diameter. The vascular stent is an annular metal net which is integrally provided with a tiny tubular object, the placement mode is that a balloon catheter is guided to an affected part, a narrow part is spread when the balloon is expanded, and then the vascular stent is placed and fixed at the place, and then the balloon is taken out; after the vascular stent is placed, the vascular stent can keep the expanded state of the original caliber, and the vascular blood is well maintained to be smooth, so that the symptom of the cerebrovascular disease is effectively reduced. And once the vascular stent is placed into a blood vessel, the vascular stent is covered by a new vascular intima, and the vascular stent is not exposed to the blood vessel and is permanently left in the body of a patient.
In clinical application of medicine, it is found that although the vascular stent can realize the vascular stent opening and effectively improve the occurrence of vascular restenosis, due to the different stent mesh areas of different stents, the unit structure design and the radial supporting force are different, so that the clinical results are also different to a certain extent. The stent mesh area of the vascular stent has a certain influence on the free area in the carotid artery, and the free area has close correlation with the curative effect of the carotid stent implantation; the unit structure design comprises two design modes of open loop and closed loop, the open loop stent is more suitable for the anatomical structure of the blood vessel, but the range covering the target lesion is smaller, the closed loop stent can cover a larger range of plaque, but the compliance of the closed loop stent is reduced and the possibility of poor adhesion is increased; if the structural design of the unit is unreasonable, the risk of hanging the umbrella is directly increased; in addition, the ideal vascular stent should have lower radial supporting force and higher vascular retraction resistance, while the existing nickel-titanium stent has high radial supporting force, and the high radial supporting force can generate continuous pressure on the carotid sinus, so that the patient is hypotensed as a direct result, and the subsequent treatment risk is increased; therefore, a vascular stent which can cover a focus part to the greatest extent and has reasonable unit structure design and can be well attached to the inner wall of a blood vessel is needed, so that the postoperative risk of carotid stent implantation is effectively reduced.
The invention aims to solve the problems of mesh area, unit structure design and radial supporting force of the existing vascular stent, and designs a vascular stent applied to a carotid artery stent, which can furthest cover focus parts by reducing the mesh area and effectively prevent stroke; the design of combining the open-loop bracket and the closed-loop bracket ensures that the bracket has higher flexibility and can cover wider plaque, and the risk of umbrella hanging is reduced to the greatest extent by making the inner surface of the bracket smooth; meanwhile, in order to reduce the occurrence rate of adverse events such as hypotension and the like, the radial supporting force is further optimized, and the integrity of the lumen is maintained.
Disclosure of Invention
In order to solve the problems that the mesh area of a vascular stent in the prior art cannot cover a focus part to the greatest extent, clinical risks exist in the design of a unit structure, and radial supporting force and vascular retraction resistance are still required to be further optimized, the invention provides the vascular stent applied to carotid arteries.
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section and an internal carotid artery stent section; the internal carotid artery stent section is provided with a first conical structure which axially and conically extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of the carotid artery vessel of the human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent and an outer stent, wherein the inner stent is made of a metal material with good biocompatibility, and the outer stent is made of a metal or nonmetal material; the surface of the inner layer support is provided with a first mesh structure penetrating through the inner layer support, the surface of the outer layer support is provided with a second mesh structure penetrating through the outer layer support, and an overlapping area for guaranteeing the flow smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through setting up the first mesh structure on the inlayer support, and the second mesh structure on the outer support carries out the differential design, has effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduces the incidence of postoperative risk.
Further, the area of the first mesh structure is smaller than that of the second mesh structure, and the area of the first mesh structure is set to 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
Further, the first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section and the lower end of the carotid artery stent section, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
Further, the open mesh is composed of a plurality of first sine wave-shaped supporting rings which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring are connected through a first connecting piece, and only one first connecting piece is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces are connected with the upper layer first sine wave-shaped supporting ring, and the lower ends of the first connecting pieces are connected with the lower layer first sine wave-shaped supporting ring.
Preferably, two adjacent first connectors are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connection points, and are sequentially connected; and the middle point connecting lines of the first connecting pieces at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
Further, in any adjacent upper and lower first sinusoidal support rings, all peaks or valleys of the upper first sinusoidal support ring are axially aligned with all peaks or valleys of the lower first sinusoidal support ring.
Or, in the adjacent upper layer and lower layer first sine wave-shaped supporting rings, the included angle between the connecting line of all wave peaks or wave troughs of the upper layer first sine wave-shaped supporting rings and all wave peaks or wave troughs of the lower layer first sine wave-shaped supporting rings in the axial direction and the vertical direction is set to be 30-45 degrees, namely, the first sine wave-shaped supporting rings are set to be spiral shapes which can adapt to the distortion form of blood vessels.
Further, corners of the first sine wave-shaped supporting ring are rounded.
Further, the angle of the peaks and the troughs of the first sine wave-shaped supporting ring is alpha, and the range of alpha is set to 45-90 degrees.
Further, the closed type meshes are closed hollow meshes formed by a plurality of diamond-shaped supporting rings distributed along the axial direction; the angle of the first diagonal of the diamond-shaped supporting ring is 30-120 degrees, and the angle of the second diagonal is 150-60 degrees. Through the design of the closed mesh structure, the stent can cover a wider range of plaque, and the plaque falling-off capability is effectively prevented.
Or the closed type meshes are closed hollow meshes which are formed by a plurality of adjacent two layers of non-intersecting second sine wave-shaped supporting rings distributed along the axial direction and second connecting pieces positioned between the adjacent upper layer of second sine wave-shaped supporting rings and the adjacent lower layer of second sine wave-shaped supporting rings; the second connecting pieces are arranged between the adjacent upper layer and lower layer second sine wave-shaped supporting rings for connection, and one second connecting piece is arranged every 1 week.
Or the closed type meshes are closed hollow meshes formed by a plurality of second sine wave-shaped supporting rings which are distributed along the axial direction and have crossing points on two adjacent layers; all wave crests or wave troughs of the upper layer second sinusoidal wave form supporting ring are aligned with all wave crests or wave troughs of the lower layer second sinusoidal wave form supporting ring in the axial direction, and wave troughs of the adjacent upper layer second sinusoidal wave form supporting ring overlap with wave crests of the lower layer second sinusoidal wave form supporting ring, and the overlapping area is diamond-shaped.
Or the closed meshes are formed by a plurality of axially distributed oval supporting rings with strong radial bearing capacity, the radially distributed adjacent oval supporting rings are connected through second connecting pieces, and the edges of the axially distributed adjacent oval supporting rings are integrally connected or connected through third connecting pieces.
Further, every adjacent 1 week first sinusoidal wave shape support ring interval contains 2 oval support rings, and the crest or the trough of first sinusoidal wave shape support ring links to each other through first connecting piece with the oval support ring edge that is located in the centre, and wherein d1 and d2, e1 and e2 are the tie point, connect gradually.
Or the closed mesh is composed of a plurality of arch-shaped supporting rings which are distributed along the axial direction and have strong retraction resistance; the arch support ring comprises a first arch support ring at the upper end and a second arch support ring at the lower end, and the lower end of the first arch support ring is fixedly connected with a port at the upper end of the second arch support ring. In addition, the adjacent arch-shaped supporting rings which are distributed in the radial direction are connected through a second connecting piece, and the adjacent arch-shaped supporting rings which are distributed in the axial direction are connected through a third connecting piece.
Further, each adjacent 1 week first sine wave-shaped supporting ring interval comprises 1 arch-shaped supporting ring, and the wave crest or the wave trough of the first sine wave-shaped supporting ring is connected with the edge of the arch-shaped supporting ring through a first connecting piece, wherein f1 and f2 are connecting points, and are sequentially connected.
Further, the central angle of the first arch-shaped supporting ring is 120 degrees, and the area of a closed graph formed by the arc length of the first arch-shaped supporting ring and the connecting lines of the two ends of the arc length is 0.01-10 mm 2 The method comprises the steps of carrying out a first treatment on the surface of the The second arched support ring conforms to the dimensional definition of the first arched support ring.
Further, the first connecting piece, the second connecting piece and the third connecting piece are arranged in a linear type, an S-shaped type or an omega-shaped type, and the length of the second connecting piece is 1/4-1/2 of that of the first connecting piece, preferably 1/3.
Further, the second mesh structure positioned on the outer layer support is a diamond mesh structure so as to adapt to clinical use requirements.
Further, the first mesh structure density of the carotid artery stent section on the stent of the inner layer is greater than the first mesh structure density of the carotid artery stent section; in the single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section is 10-100, and the number of first meshes positioned in the carotid artery stent section is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
Further, the first mesh structure area of the carotid artery stent section on the inner stent is smaller than the first mesh structure area of the carotid artery stent section; the first mesh structure area of the internal carotid artery stent section is 0.02-6 mm 2 The area of the first mesh structure positioned at the carotid artery stent section is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
Further, the outer layer bracket is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
Further, a fully coated, partially coated or uncoated film structure is arranged on the outer stent, and the film structure is made of terylene or polytetrafluoroethylene and is used for ensuring the smoothness of blood flow in the carotid artery.
Further, a film covering structure is arranged in the area where the closed type mesh is located, and the area where the open type mesh is located is not covered.
Further, a drug coating capable of effectively diluting blood or inhibiting intimal hyperplasia is arranged on the inner surface and/or the outer surface of the inner layer stent; wherein the diluted blood medicine coating is diluted blood medicine such as heparin, and the medicine coating for inhibiting intimal hyperplasia is medicine such as paclitaxel and rapamycin.
Further, the length of the carotid artery stent section ranges from 5 to 16 mm; the length of the carotid artery stent section ranges from 6 to 15 mm.
Preferably, the length of the carotid artery stent section ranges from 8-10 mm; the length range of the carotid artery stent section is 8-10 mm, and the setting of the length can effectively ensure the opening effect on the narrow carotid artery.
Further, the diameter of the carotid artery stent section is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section is not smaller than the diameter of the carotid artery stent section, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Compared with the prior art, the vascular stent has the advantages that the conical structure which is integrally matched with the shape of the carotid blood vessel of a human body or the double-layer tubular stent body with the conical structure at the carotid artery part is arranged, and the size and the density of the area of the first mesh structure on the inner-layer stent are limited, so that the clinical use requirement is met to the greatest extent. In the technical scheme, the narrow artery part is mainly supported by the closed mesh, and the two ends of the narrow artery are supported by the first sine wave-shaped supporting rings with better expansibility, so that the stent can be completely expanded to be clung to the inner wall of a blood vessel. In addition, the technical scheme plays a certain role in preventing restenosis of the blood vessel by selectively adding the tectorial membrane structure and the drug coating on the blood vessel stent.
Drawings
FIG. 1 is a schematic view of the overall structure of the present invention in a generally conical configuration;
FIG. 2 is a schematic view of the overall structure of the inner stent of the present invention in a generally conical configuration;
FIG. 3 is a schematic view of the overall structure of the internal carotid artery stent of the present invention with a straight cylindrical shape and a conical internal carotid artery stent;
FIG. 4 is a schematic view of the overall structure of the outer stent of the present invention in its overall tapered configuration;
FIG. 5 is an enlarged partial schematic view of the inner stent of the first sinusoidal wave shaped supporting ring of the present invention;
FIG. 6 is a schematic view of a partial enlarged structure of an inner stent at the junction between a first sinusoidal wave shaped support ring and a diamond shaped support ring according to the present invention;
FIG. 7 is a schematic view of a partial enlarged structure of an inner stent and an outer stent at the junction between a first sinusoidal wave shaped support ring and a diamond shaped support ring according to the present invention;
FIG. 8 is a schematic view of a partial enlarged structure of an inner stent of a second sinusoidal wave form support ring (disjoint) of the present invention;
FIG. 9 is a schematic view of an enlarged partial structure of an inner stent at the junction between a first sinusoidal support ring and a second sinusoidal support ring (where there are intersections) of the present invention;
FIG. 10 is a schematic view of a partial enlarged structure of an inner stent at the junction between a first sinusoidal support ring and an oval support ring according to the present invention;
FIG. 11 is a schematic view of a partial enlarged structure of an inner stent of an oval support ring of the present invention;
FIG. 12 is a schematic view of a partial enlarged construction of an inner stent at the junction between a first sinusoidal support ring and an arched support ring in accordance with the present invention;
FIG. 13 is a schematic view of an enlarged partial structure of an inner bracket of an arched support ring according to the present invention;
in the figure, 1, a common carotid artery stent segment; 2. an internal carotid artery stent segment; 3. an inner layer support; 4. an outer layer support; 5. a first sinusoidal wave shaped support ring; 6. a first connector; 71. a diamond-shaped support ring; 72. a second sinusoidal wave shaped support ring; 73. an elliptical support ring; 74. an arched support ring; 75. a second connector; 76. and a third connecting piece.
Detailed Description
The following detailed description of the embodiments of the present invention will be made more apparent to those skilled in the art from the following detailed description, in which the invention is embodied in several, but not all, embodiments of the invention. The invention may be embodied or applied in other specific forms and features of the following examples and examples may be combined with each other without conflict, all other examples being contemplated by those of ordinary skill in the art without undue burden from the present disclosure, based on the examples of the invention.
Example 1A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In any adjacent upper and lower first sinusoidal support rings 5, all peaks or valleys of the upper first sinusoidal support ring 5 are axially aligned with all peaks or valleys of the lower first sinusoidal support ring 5.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed type meshes are closed hollow meshes formed by a plurality of diamond-shaped supporting rings 71 distributed along the axial direction; the angle of the first diagonal of the diamond-shaped support ring 71 is 30-120 degrees and the angle of the second diagonal is 150-60 degrees. Through the design of the closed mesh structure, the stent can cover a wider range of plaque, and the plaque falling-off capability is effectively prevented.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Example 2A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In any adjacent upper and lower first sinusoidal support rings 5, all peaks or valleys of the upper first sinusoidal support ring 5 are axially aligned with all peaks or valleys of the lower first sinusoidal support ring 5.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed type meshes are closed hollow meshes formed by a plurality of diamond-shaped supporting rings 71 distributed along the axial direction; the angle of the first diagonal of the diamond-shaped support ring 71 is 30-120 degrees and the angle of the second diagonal is 150-60 degrees. Through the design of the closed mesh structure, the stent can cover a wider range of plaque, and the plaque falling-off capability is effectively prevented.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The outer stent 4 is provided with a partially coated film structure which is made of terylene or polytetrafluoroethylene and is used for ensuring the smoothness of blood flow in the external carotid artery.
And arranging a film covering structure in the area where the closed type mesh is positioned, and arranging an uncoated structure in the area where the open type mesh is positioned.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Example 3A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In the adjacent upper layer and lower layer first sine wave-shaped supporting rings 5, the included angle between the connecting line of all wave peaks or wave troughs of the upper layer first sine wave-shaped supporting rings 5 and all wave peaks or wave troughs of the lower layer first sine wave-shaped supporting rings 5 in the axial direction and the vertical direction is set to be 30-45 degrees, namely the first sine wave-shaped supporting rings 5 are arranged to be spiral shapes which can adapt to the blood vessel distortion forms.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed type mesh is a closed hollow mesh formed by a plurality of two adjacent layers of non-intersecting second sine wave-shaped supporting rings 72 distributed along the axial direction and second connecting pieces 75 positioned between the adjacent upper layer of second sine wave-shaped supporting rings 72 and the adjacent lower layer of second sine wave-shaped supporting rings 72; the second connection members 75 are provided between the adjacent upper and lower second sinusoidal wave shaped support rings 72, and one second connection member 75 is provided every 1 week.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The outer stent 4 is provided with a fully-coated film structure which is made of terylene or polytetrafluoroethylene and used for ensuring the smoothness of blood flow in the external carotid artery.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Example 4A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In the adjacent upper layer and lower layer first sine wave-shaped supporting rings 5, the included angle between the connecting line of all wave peaks or wave troughs of the upper layer first sine wave-shaped supporting rings 5 and all wave peaks or wave troughs of the lower layer first sine wave-shaped supporting rings 5 in the axial direction and the vertical direction is set to be 30-45 degrees, namely the first sine wave-shaped supporting rings 5 are arranged to be spiral shapes which can adapt to the blood vessel distortion forms.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed type mesh is a closed hollow mesh formed by a plurality of second sine wave-shaped supporting rings 72 which are distributed along the axial direction and have crossing points on two adjacent layers; all peaks or valleys of the upper layer second sinusoidal wave shape supporting ring 72 are axially aligned with all peaks or valleys of the lower layer second sinusoidal wave shape supporting ring 72, and the valleys of the adjacent upper layer second sinusoidal wave shape supporting ring 72 overlap with the peaks of the lower layer second sinusoidal wave shape supporting ring 72, and the overlapping area is diamond-shaped.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The outer stent 4 is provided with an uncoated tectorial membrane structure which is made of terylene or polytetrafluoroethylene and used for ensuring the smoothness of blood flow in the external carotid artery.
The inner surface and/or the outer surface of the inner layer bracket 3 and the inner surface and/or the outer surface of the outer layer bracket 4 are provided with a drug coating which can effectively dilute blood or inhibit intimal hyperplasia; wherein the diluted blood medicine coating is diluted blood medicine such as heparin, and the medicine coating for inhibiting intimal hyperplasia is medicine such as paclitaxel and rapamycin.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Example 5A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In any adjacent upper and lower first sinusoidal support rings 5, all peaks or valleys of the upper first sinusoidal support ring 5 are axially aligned with all peaks or valleys of the lower first sinusoidal support ring 5.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed mesh is composed of a plurality of axially distributed oval support rings 73 with strong radial bearing capacity, the radially distributed adjacent oval support rings 73 are connected through second connecting pieces 75, and the edges of the axially distributed adjacent oval support rings 73 are integrally connected or connected through third connecting pieces 76.
Every adjacent 1 week of the first sinusoidal supporting ring 5 comprises 2 oval supporting rings 73, and the peaks or the troughs of the first sinusoidal supporting ring 5 are connected with the edges of the oval supporting ring 73 positioned in the middle through a first connecting piece 6, wherein d1 and d2, and e1 and e2 are connecting points which are sequentially connected.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
Example 6A vascular stent for carotid artery
A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section 1 and an internal carotid artery stent section 2; the internal carotid artery stent is characterized in that the internal carotid artery stent section 2 is provided with a first conical structure which is axially conical and extends upwards and is matched with the shape of a human internal carotid artery blood vessel, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section 1 is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of a carotid artery vessel of a human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent 3 and an outer stent 4, wherein the inner stent 3 is made of a metal material with good biocompatibility, and the outer stent 4 is made of a metal or nonmetal material; the surface of the inner layer support 3 is provided with a first mesh structure penetrating through the inner layer support 3, the surface of the outer layer support 4 is provided with a second mesh structure penetrating through the outer layer support 4, and an overlapping area ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure. Through setting up the tubular support body identical with human vascular shape to through carrying out the differential design to the first mesh structure that sets up on inlayer support 3, and the second mesh structure on outer support 4, effectively guaranteed to put into the unblocked and stable of each branch blood flow behind the affected part with this support, reduce the incidence of postoperative risk.
The first mesh structure has an area smaller than that of the second mesh structure, and the first mesh structure has an area of 0.02-20 mm 2 The area of the second mesh structure is set to 1-30 mm 2
The first mesh structure comprises open meshes positioned at the upper end of the carotid artery stent section 2 and the lower end of the carotid artery stent section 1, and closed meshes positioned between the open meshes at the two ends; the design of the open loop at the two ends and the closed loop in the middle combines the advantages of the open loop stent and the closed loop stent, has higher flexibility to adapt to the complex anatomical structure of the carotid artery, and can cover wider plaque.
The open mesh consists of a plurality of first sinusoidal wave-shaped supporting rings 5 which are distributed along the axial direction and have good expansibility, so that the vascular stent can be completely expanded to be closely attached to the inner wall of a blood vessel; the upper layer and the lower layer of the first sine wave-shaped supporting ring 5 are connected through a first connecting piece 6, and only one first connecting piece 6 is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces 6 are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces 6 are connected with the upper layer first sine wave-shaped supporting ring 5, and the lower ends of the first connecting pieces 6 are connected with the lower layer first sine wave-shaped supporting ring 5.
Two adjacent first connecting pieces 6 are arranged at intervals of 2.5 weeks, wherein a1 and a2, b1 and b2, and c1 and c2 are connecting points and are sequentially connected; and the middle point connecting lines of the first connecting piece 6 at the positions of a1 and a2, b1 and b2 and c1 and c2 are spiral. The arrangement can effectively ensure that the support has good flexibility.
In any adjacent upper and lower first sinusoidal support rings 5, all peaks or valleys of the upper first sinusoidal support ring 5 are axially aligned with all peaks or valleys of the lower first sinusoidal support ring 5.
Corners of the first sine wave-shaped supporting ring 5 are rounded.
The angle of the wave crest and the wave trough of the first sine wave-shaped supporting ring 5 is alpha, and the range of alpha is set to 45-90 degrees.
The closed mesh is composed of a plurality of axially distributed arch-shaped support rings 74 with high retraction resistance; the arched support rings 74 include a first arched support ring 74 at an upper end and a second arched support ring 74 at a lower end, the lower end of the first arched support ring 74 being fixedly connected to a port at the upper end of the second arched support ring 74. In addition, radially disposed adjacent arched support rings 74 are connected by a second connector 75, and axially disposed adjacent arched support rings 74 are connected by a third connector 76.
Each adjacent 1 week first sinusoidal wave-shaped supporting ring 5 interval contains 1 arch-shaped supporting ring 74, and the crest or trough of first sinusoidal wave-shaped supporting ring 5 is connected with the edge that is located arch-shaped supporting ring 74 through first connecting piece 6, wherein f1 and f2 are the tie point, connect in proper order.
The central angle of the first arch-shaped supporting ring 74 is 120 degrees, and the area of a closed graph formed by the arc length of the first arch-shaped supporting ring 74 and the connecting lines of the two ends of the arc length is 0.01-10 mm 2 The method comprises the steps of carrying out a first treatment on the surface of the The second arched support ring 74 conforms to the dimensional definition of the first arched support ring 74.
The first connecting member 6 and the second connecting member 75 and the third connecting member 76 are provided in a linear type or an S-type or an omega-type, and the length of the second connecting member 75 is 1/4 to 1/2, preferably 1/3, of the first connecting member 6.
The second mesh structure on the outer layer support 4 is a diamond mesh structure so as to adapt to clinical use requirements.
The first mesh structure density of the carotid artery stent section 2 on the inner stent 3 is greater than the first mesh structure density of the carotid artery stent section 1; in a single diamond-shaped mesh structure of the second mesh structure, the number of first meshes positioned in the carotid artery stent section 2 is 10-100, and the number of first meshes positioned in the carotid artery stent section 1 is 8-50; the arrangement can effectively ensure that the blood flow passing rate at the common carotid artery is larger than that at the internal carotid artery.
The first mesh structure area of the carotid artery stent section 2 on the inner stent 3 is smaller than the first mesh structure area of the carotid artery stent section 1; the first mesh structure area of the internal carotid artery stent section 2 is set to 0.02-6 mm 2 The area of the first mesh structure positioned on the carotid artery stent section 1 is set to be 1-20 mm 2 . The mesh area ensures the smoothness of blood flow to the maximum extent and effectively prevents stroke.
The outer layer bracket 4 is made of a self-expansion nickel-titanium alloy layer or a cobalt-chromium alloy layer, polyester resin or polyester resin (PET) or expanded polytetrafluoroethylene (e-PTFE) material.
The inner surface and/or the outer surface of the inner layer bracket 3 and the inner surface and/or the outer surface of the outer layer bracket 4 are provided with a drug coating which can effectively dilute blood or inhibit intimal hyperplasia; wherein the diluted blood medicine coating is diluted blood medicine such as heparin, and the medicine coating for inhibiting intimal hyperplasia is medicine such as paclitaxel and rapamycin.
The length of the carotid artery stent section 2 ranges from 8 to 10 mm; the length of the carotid artery stent section 1 ranges from 8 to 10 mm, and the length can effectively ensure the opening effect on the narrow carotid artery.
The diameter of the carotid artery stent section 2 is in the range of 5-6 mm; the minimum diameter of the carotid artery stent section 1 is not smaller than the diameter of the carotid artery stent section 2, and the maximum diameter is smaller than 10 mm; the device can meet the operation requirements of internal carotid arteries and common carotid arteries of most patients.
The above description of embodiments is only for the understanding of the present invention. It should be noted that it will be apparent to those skilled in the art that modifications can be made to the present invention without departing from the principles of the invention, and such modifications will fall within the scope of the claims.

Claims (12)

1. A vascular stent applied to carotid artery, which comprises a tubular stent body formed by butting a carotid artery stent section and an internal carotid artery stent section; the internal carotid artery stent is characterized in that the internal carotid artery stent section is provided with a first conical structure which is matched with the shape of a human internal carotid artery blood vessel and extends upwards in an axial conical manner, and the area of the cross section of the upper end of the first conical structure is smaller than that of the cross section of the lower end of the first conical structure; the carotid artery stent section is arranged into a second conical structure or a straight cylindrical structure which is matched with the shape of the carotid artery vessel of the human body and extends upwards in an axial conical manner, the upper end of the second conical structure is consistent with the lower end of the first conical structure in size, the inclination of the second conical structure and the inclination of the first conical structure are consistent, and the upper end of the straight cylindrical structure is consistent with the lower end of the first conical structure in size; the tubular stent body comprises an inner stent and an outer stent, wherein the inner stent is made of a metal material with good biocompatibility, and the outer stent is made of a metal or nonmetal material; a first mesh structure penetrating through the inner layer stent is arranged on the surface of the inner layer stent, a second mesh structure penetrating through the outer layer stent is arranged on the surface of the outer layer stent, and an overlapping area for ensuring the smoothness of blood flow exists between the first mesh structure and the second mesh structure; the first mesh structure density of the carotid artery stent section on the inner stent is greater than the first mesh structure density of the carotid artery stent section; in the single diamond-shaped mesh structure of the second mesh structure, the number of the first mesh structures positioned in the carotid artery stent section is 10-100, and the number of the first mesh structures positioned in the carotid artery stent section is 8-50.
2. The stent of claim 1, wherein the open mesh comprises a plurality of axially distributed first sinusoidal support rings with good expansion properties, such that the stent can be fully expanded against the vessel wall; the upper layer and the lower layer of the first sine wave-shaped supporting ring are connected through a first connecting piece, and only one first connecting piece is arranged between the adjacent upper layer and lower layer; and two adjacent first connecting pieces are arranged at intervals of 1.5-4.5 weeks, the upper ends of the first connecting pieces are connected with the upper layer first sine wave-shaped supporting ring, and the lower ends of the first connecting pieces are connected with the lower layer first sine wave-shaped supporting ring.
3. A stent for application to the carotid artery as defined in claim 2 wherein, in any adjacent upper and lower first sinusoidal support rings, all peaks or troughs of the upper first sinusoidal support ring are axially aligned with all peaks or troughs of the lower first sinusoidal support ring.
4. A vascular stent for carotid artery according to claim 2, wherein the included angle between the connection line of all peaks or troughs of the upper layer first sinusoidal wave form support ring and all peaks or troughs of the lower layer first sinusoidal wave form support ring in the axial direction and the vertical direction is set to 30-45 degrees, namely the first sinusoidal wave form support ring is set to a spiral shape capable of adapting to the blood vessel twisting form.
5. The vascular stent for carotid artery of claim 1, wherein the closed mesh is a closed hollowed mesh comprised of a plurality of axially distributed adjacent two layers of disjoint second sinusoidal wave shaped support rings and a second connector between adjacent upper and lower layers of second sinusoidal wave shaped support rings; the second connecting pieces are arranged between the adjacent upper layer and lower layer second sine wave-shaped supporting rings for connection, and one second connecting piece is arranged every 1 week.
6. The vascular stent for carotid artery of claim 1, wherein the closed mesh is a closed hollow mesh consisting of a plurality of second sinusoidal wave-shaped support rings with crossing points on two adjacent layers distributed along the axial direction; all wave crests or wave troughs of the upper layer second sinusoidal wave form supporting ring are aligned with all wave crests or wave troughs of the lower layer second sinusoidal wave form supporting ring in the axial direction, and wave troughs of the adjacent upper layer second sinusoidal wave form supporting ring overlap with wave crests of the lower layer second sinusoidal wave form supporting ring, and the overlapping area is diamond-shaped.
7. A vascular stent for carotid artery according to claim 1, wherein the closed mesh is composed of a plurality of axially distributed oval support rings with strong radial bearing capacity, wherein the radially distributed adjacent oval support rings are connected by a second connecting piece, and the edges of the axially distributed adjacent oval support rings are integrally connected or connected by a third connecting piece.
8. A vascular stent for carotid artery application as defined in claim 1 wherein said closed mesh is comprised of a plurality of axially distributed arch-shaped support rings with high resistance to recoil; the arch support ring comprises a first arch support ring at the upper end and a second arch support ring at the lower end, and the lower end of the first arch support ring is fixedly connected with a port at the upper end of the second arch support ring; the adjacent arch-shaped supporting rings which are distributed in the radial direction are connected through a second connecting piece, and the adjacent arch-shaped supporting rings which are distributed in the axial direction are connected through a third connecting piece.
9. The stent of claim 8, wherein the central angle of the first arch-shaped support ring is 120 degrees, and the area of the closed figure formed by the connection line between the arc length of the first arch-shaped support ring and the two ends of the arc length is 0.01-10 mm 2 The method comprises the steps of carrying out a first treatment on the surface of the The second arched support ring conforms to the dimensional definition of the first arched support ring.
10. The vascular stent of claim 1, wherein the first mesh structure area of the carotid stent segment on the stent is smaller than the first mesh structure area of the carotid stent segment; the first mesh structure area of the internal carotid artery stent section is 0.02-6 mm 2 The area of the first mesh structure positioned at the carotid artery stent section is set to be 1-20 mm 2
11. A vascular stent for carotid artery application according to claim 10, wherein the area of the closed mesh is covered with a membrane, and the area of the open mesh is uncovered.
12. A vascular stent for carotid artery application according to claim 11, wherein a drug coating effective to dilute blood or inhibit intimal hyperplasia is provided on the inner and/or outer surface of the inner stent; wherein the diluted blood medicine coating is heparin diluted blood medicine, and the intimal hyperplasia inhibiting medicine coating is paclitaxel and rapamycin medicine.
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