WO2023284595A1 - Endoprothèse médicale - Google Patents

Endoprothèse médicale Download PDF

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Publication number
WO2023284595A1
WO2023284595A1 PCT/CN2022/104018 CN2022104018W WO2023284595A1 WO 2023284595 A1 WO2023284595 A1 WO 2023284595A1 CN 2022104018 W CN2022104018 W CN 2022104018W WO 2023284595 A1 WO2023284595 A1 WO 2023284595A1
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WO
WIPO (PCT)
Prior art keywords
stent
thick
inner layer
outer layer
medical
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Application number
PCT/CN2022/104018
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English (en)
Chinese (zh)
Inventor
黄云帆
周炯
Original Assignee
神途医疗科技(上海)有限公司
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Publication of WO2023284595A1 publication Critical patent/WO2023284595A1/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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical bracket.
  • Carotid angioplasty and stenting is a new minimally invasive and low-invasive interventional treatment developed in the past ten years, with high surgical efficiency and simple implementation.
  • CAS Carotid angioplasty and stenting
  • a small puncture hole is made in the patient's femoral artery, the protective device is sent to the carotid artery through the catheter, and then the stent is placed to stretch the hardened and narrowed carotid artery.
  • the entire operation does not take long, and the success rate exceeds 98%, which can effectively reduce the chance of ischemic stroke caused by carotid artery stenosis.
  • the length of hospital stay for CAS surgery is short, especially for older patients who are not candidates for major surgery.
  • the carotid stent is woven with a dense mesh, and the mesh is relatively large, usually more than 1 mm 2 , which causes the plaque to fall easily after the stenosis is expanded, resulting in stroke.
  • the radial support force of the carotid artery stent braided with a dense mesh is relatively small, and it cannot well expand the hardened and narrowed carotid artery.
  • the carotid stent has a large mesh and a small radial support force, and the effect of treating carotid stenosis is not good.
  • the purpose of the present invention is to provide a medical stent to solve the problem of large grid and small radial support force in the prior art carotid artery stent.
  • the present invention provides a medical stent: comprising: the outer layer of the stent and the inner layer of the stent; wherein,
  • the outer layer of the stent is a tubular body woven by first filaments covering the inner layer of the stent;
  • the inner layer of the stent includes a thick wire structure and a thin wire structure with opposite helical directions and the same extension direction. lock up.
  • a part or the whole of the inner layer of the stent is integrally braided with the outer layer of the stent.
  • the inner layer of the stent is interwoven with the outer layer of the stent every set distance.
  • the inner layer of the stent includes 1-10 thick wires.
  • the thick wires do not intersect each other.
  • the inner layer of the stent when the inner layer of the stent includes at least 2 thick wires, the tails of every n consecutive thick wires are connected, and n is a positive integer greater than 2.
  • the filament structure includes 2 second filaments, and the 2 second filaments rotate and interweave with each other to form a plurality of interweaving loops.
  • the inner layer of the stent includes a plurality of filament structures.
  • the plurality of filament structures do not intersect each other.
  • the thick wire, the second thin wire and the first thin wire are made of the same material, and the thick wire, the second thin wire, the The diameters of the first filaments decrease sequentially.
  • the outer layer of the stent is formed by weaving the first filaments in two directions at an angle to each other by sinking and floating by 1 interval 1, 1 interval 2 or 2 intervals 2 .
  • the grid area of the outer layer of the stent is 0.04mm 2 -0.09mm 2 .
  • the medical stent provided by the present invention includes that the outer layer of the stent is a tubular body woven from the first filament and covers the inner layer of the stent; the inner layer of the stent includes Thick filaments and thin filaments with the same extension direction, the filament structure has a plurality of interweaving loops arranged in sequence along the extension direction, and the thick filaments are threaded through the plurality of interweaving loops.
  • the outer layer of the stent bears the role of covering the plaque in the blood vessel, while the inner layer of the stent formed by the helical extension of the thick wire and the thin wire structure has better mechanical properties, large radial force, and resistance Deformation, but also high flexibility, can continuously dilate blood vessels in narrowed areas;
  • the thick wire is threaded through the interweaving circle of the thin wire structure, and the thin wire structure can not only fix the thick wire, but also provide a moving space for the thick wire when bending, and It can prevent the deformation of the bracket caused by the excessive displacement of the thick wire;
  • part or the whole of the inner layer of the stent is integrally braided with the outer layer of the stent, so that the inner layer of the stent will not be detached from the outer layer of the stent, thereby achieving high stability of the stent.
  • Fig. 1 is the structural representation of the medical stent provided by the embodiment of the present invention.
  • Figure 2a is a schematic diagram of the non-interlaced part of the stent outer layer and the stent inner layer of the medical stent provided by the embodiment of the present invention
  • Fig. 2b is a schematic diagram of the interweaving part of the stent outer layer and the stent inner layer of the medical stent provided by the embodiment of the present invention
  • Fig. 3 is a schematic structural view of the inner layer of the stent comprising two thick wires in an embodiment of the present invention
  • Fig. 4 is a schematic view of the state of the thick wire when the medical stent provided by the embodiment of the present invention is bent;
  • Fig. 5 is a schematic diagram of the effect of the open-loop stent shown in the embodiment of the present invention.
  • Fig. 6 is a structural schematic diagram of the filament structure described in the embodiment of the present invention.
  • Fig. 7 is a schematic diagram of the connection state between the thick wires in the embodiment of the present invention.
  • Fig. 8 is a weaving structure diagram of the outer layer of the stent in the embodiment of the present invention.
  • Fig. 9a is a schematic diagram of the first weaving method of the outer layer of the stent in the example of the embodiment of the present invention.
  • Fig. 9b is a schematic diagram of the second weaving method of the outer layer of the stent in the example of the embodiment of the present invention.
  • Fig. 9c is a schematic diagram of the third weaving method of the outer layer of the stent according to the embodiment of the present invention.
  • an embodiment of the present invention provides a medical stent, which is characterized in that it includes: a stent outer layer 1 and a stent inner layer 2; wherein,
  • the stent outer layer 1 is a tubular body covered with the stent inner layer 2 woven by first filaments;
  • the stent inner layer 2 includes thick wires 21 and thin wire structures 22 with opposite helical directions and the same extension direction; a plurality of said interweaving loops.
  • the outer layer 1 of the stent bears the role of plaque coverage
  • the inner layer 2 of the stent formed by the helical extension of the thick wire 21 and the thin wire structure 22 has better excellent mechanical properties, large radial force, resistance to deformation, and high flexibility, which can continuously dilate blood vessels in narrowed places; in addition, since the thick wire 21 is threaded through the interweaving circle 101 of the thin wire structure 22, the The thin wire structure 22 not only fixes the thick wire 21, but also provides a moving space for the thick wire 21 when it is bent, and prevents the bracket from being deformed due to excessive displacement of the thick wire 21.
  • the thick wire 21 and the thin wire structure 22 can be integrally braided on the braided mandrel 4, and then the braided mandrel 4 is pulled out of the stent formed by braiding. Pull out. And preferably, part or the whole of the stent inner layer 2 is integrally braided with the stent outer layer 1, so that the stent inner layer 2 will not be detached from the stent outer layer 1 to achieve high stability of the stent sex.
  • the stent inner layer 2 is integrally braided with the stent outer layer 1 through a part or the whole of the thick wire 21 , and/or, a part or the whole of the thin wire structure 22 and the stent outer layer 1 .
  • the stent outer layer 1 interweaves with the stent inner layer 2 at some positions, and the stent outer layer 1 interweaves with the thick wire 21 in the stent inner layer 2 at some positions.
  • the difficulty of weaving can be reduced due to the reduced number of interweaving times.
  • the stent outer layer 1 is not interwoven with the stent inner layer 2, the stent outer layer 1 is close to the blood vessel wall 3; please Referring to Fig. 2b, at the position where the stent outer layer 1 and the stent inner layer 2 interweave, the stent inner layer 2 is close to the vessel wall 3, specifically, in the stent outer layer 1 and the stent inner layer At the position where the layers 2 are interwoven, the thick filaments 21 in the inner layer 2 of the stent are tightly attached to the vessel wall 3 .
  • the stent inner layer 2 interweaves with the stent outer layer 1 every set distance apart, that is, every set distance apart, the stent inner layer 2
  • the thick filaments 21 of layer 2 are interwoven with the outer layer of the stent.
  • the set distance can be specifically designed according to the axial length of the bracket. In this embodiment, the set distance can be 1/2 of the total axial length of the bracket.
  • the The inner layer 2 of the stent is interwoven with the outer layer 1 of the stent, and at both ends of the stent, the inner layer 2 of the stent is interwoven with the outer layer 1 of the stent, so the set distance is the total axial length of the stent 1/2 of the stent, when the axial length of the stent becomes longer, the set distance, for example, can also be 1/3, 1/4, etc.
  • the stent inner layer 2 includes one thick wire 21 , and preferably, the one thick wire 21 has no intersection point on the extending path.
  • the stent inner layer 2 includes two or more thick wires 21 extending helically in the same direction, preferably, one or more thick wires 21 extending helically in the same direction do not intersect each other; The combined use of two or more than two thick wires 21 enables the stent to have a good uniform support effect.
  • Each of the thick wires 21 forms a helical structure, and the helical structures do not intersect each other. The existence of the helical structure makes the stent It has good flexibility and adhesion.
  • the stent inner layer 2 includes 1 to 10 thick wires 21, and the number of thick wires 21 can be selected according to the target support force of the stent and the thick wires 21 themselves. tuned performance characteristics.
  • Fig. 3 is an example that the stent layer contains 2 thick wires 21.
  • the stent processed at a braiding angle of 45° has a high resistance to bending deformation.
  • B/A is greater than 95%, see Figure 5, where B is the diameter of the bend, and A is the diameter of both ends of the bend.
  • the stent since there is no intersection point between the helical structures formed by the thick filaments 21, the stent will not be bent when bent, similar to the effect shown in Fig. 5, when the bending angle is large, the bent Small changes in the diameter of the stent at this location allow for high compliance. Further, in order to ensure that the helical structures formed by each of the thick filaments 21 do not intersect with each other, the helical structures formed by each of the thick filaments 21 can be set to have the same helix angle; in other embodiments, the The thick filaments 21 have different helix angles, and there are intersection points between the thick filaments 21 .
  • the filament structure 22 includes 2 second filaments, and the 2 second filaments rotate and interweave with each other to form multiple interweaving points.
  • An interweaving loop 101 is formed between them, so that the filament structure 22 has a plurality of interlacing loops 101 arranged in sequence along the helical extension direction.
  • the stent inner layer 2 includes a plurality of filament structures 22 . More preferably, the plurality of filament structures 22 do not intersect each other, that is, each filament structure 22 forms a helical structure, and the helical structures formed by each filament structure 22 do not intersect each other. In other embodiments, intersections exist between the plurality of filamentary structures.
  • the multiple thin wire structures 22 are designed so that when the helical structure formed by the thick wires 21 is bent, each part can be limited in displacement by the thin wires, so that the stent can be deformed within a target range.
  • the size of the interweaving loops 101 may be uniform or non-uniform.
  • the thick filaments 21 pass through all the interlaced loops 101 of the thin filament structure 22 ; in other embodiments, the thick filaments 21 pass through part of the interwoven loops 101 of the filament structure 22 .
  • one thick wire 21 is passed through a single interweaving loop 101; 2 or 3 of the thick filaments are threaded in the interweaving loops 101; Describe thick silk 21.
  • Figure 6 illustrates an embodiment of the specific weaving structure of the inner layer of the stent 2, the thick wire 21 spirals in one direction to form a helical structure, and the second thin wire spirals in the opposite direction to the thick wire 21.
  • every two second filaments are twisted and intertwined with each other to form several interweaving points, and the thick filaments 21 run through between the two interweaving points, this structure can prevent the thick filaments 21 from occurring displacement in the axial direction.
  • the interweaving point formed by the intertwining and intertwining of the second filaments may contain multiple twisting knots, for example, the interweaving point between two filaments is formed by two twisting knots.
  • each plurality of second filaments are intertwined and intertwined with each other to form several intertwined points, for example, three or four of the second filaments are intertwined and intertwined with each other to form intertwined points.
  • the tails of every n consecutive thick wires 21 are connected to form a connecting portion 201 , wherein, n is a positive integer greater than 2, that is to say, a connecting portion can be formed by connecting the tails of every two adjacent thick wires 21 , or a connecting portion can be formed by connecting the tails of every consecutive thick wires 21 , or, the tails of all the thick wires 21 are connected to form a connecting portion.
  • a connecting portion can be formed by connecting the tails of every two adjacent thick wires 21
  • a connecting portion can be formed by connecting the tails of every consecutive thick wires 21
  • the tails of all the thick wires 21 are connected to form a connecting portion.
  • the tails of the thick filaments 21 are smoothed to form smooth edges and prevent blood vessels from being punctured.
  • the tails of all the thick wires 21 may be welded to form smooth edges.
  • the tail of the thick wire 21 may also be cut directly and then smoothed.
  • the way of the smoothing treatment can be, for example, grinding treatment, coating, etc., and the application does not limit the way of smoothing the tail of the thick wire 21 .
  • the outer layer 1 of the stent is a fabric structure braided by the first filaments in two directions at angles to each other.
  • the first filaments in the two directions at an angle to each other sink and float at intervals of one at a time, and as shown in Figure 9b, the two angles at each other
  • the first filaments in one direction sink and float with each other at intervals of 2, or as shown in FIG.
  • the mesh area of the outer layer 1 of the stent is 0.04mm 2 -0.09mm 2 , which has a good effect in preventing the thrombus falling from the plaque from escaping.
  • other weaving methods can also be selected to form the outer layer 1 of the stent.
  • this application there is no limit to the method of forming the outer layer 1 of the stent by weaving, as long as the outer layer 1 of the stent is ensured.
  • the grid area may be within the range of 0.04mm 2 to 0.09mm 2 .
  • the thick wire 21, the second thin wire and the first thin wire can be made of the same material, such as cobalt-chromium alloy, nickel-titanium alloy, tungsten wire, and stainless steel wire.
  • the thick wire 21, the second thin wire and the first thin wire can be made of different materials, for example, the thick wire 21, the second thin wire and the first thin wire are respectively made of Any one of cobalt-chromium alloy, nickel-titanium alloy, tungsten wire, stainless steel wire, and metal composite wire.
  • any one or several of the thick wire 21, the second thin wire, and the first thin wire is made of radiopaque developing wire, such as platinum wire, platinum tungsten wire, platinum wire, etc.
  • the diameters of the thick wire 21, the second thin wire, and the first thin wire decrease sequentially, so that the hardness of the thick wire 21 is greater than the hardness of the second thin wire > the hardness of the first thin wire, so that the thick wire 21 with a relatively large wire diameter can be used to provide structural support for expanding outward against the blood vessel, and the second wire with a relatively small diameter can be used
  • the thin wires limit the degree of bending or compression of the thick wires 21, so that the overall stent is not easily deformed, and the outer layer 1 of the braided stent meets the requirements of 0.04 mm 2 to 0.09 mm by using the first thin wire with the smallest wire diameter. mm 2 grid area requirements.
  • the diameter of the thick wire 21 is the largest, and the diameters of the second thin wire and the first thin wire may be the same.
  • the diameter of the thick wire 21 may be 4/1000-6/1000 inch
  • the diameter of the second thin wire may be 21/10000-35/10000 inch
  • the first The diameter of the filaments can be 10/10000-16/10000 inch.
  • the medical stent includes: an outer layer of a stent and an inner layer of a stent; wherein, the outer layer of the stent is a tubular body woven from a first filament covering the inner layer of the stent ; the inner layer of the stent includes a thick wire structure and a thin wire structure with opposite helical directions and the same extension direction, the thin wire structure has a plurality of interweaving circles arranged in sequence along the extension direction, and the thick wire passes through a plurality of the interwoven circles.
  • the outer layer of the stent bears the role of covering the plaque, while the inner layer of the stent formed by the helical extension of the thick wire and the thin wire structure has better mechanical properties, radial Strong force, resistance to deformation, and high flexibility at the same time, can continuously expand the narrowed blood vessels; in addition, because the thick wire is passed through the interweaving circle of the thin wire structure, the thin wire structure can fix the At the same time, the thick wires can also provide a moving space for the thick wires when they are bent, and can prevent the deformation of the stent caused by excessive displacement of the thick wires.
  • the medical stent provided by the present invention can be used in the carotid artery, and can also be applied to other parts in need, such as the subclavian artery, vertebral artery ostium, intracranial blood vessels, peripheral blood vessels, coronary arteries, etc. Applications are not limited to this.

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

Abstract

Une endoprothèse médicale comprend une couche externe d'endoprothèse (1) et une couche interne d'endoprothèse (2). La couche externe d'endoprothèse (1) est un corps tubulaire recouvrant la couche interne d'endoprothèse (2) et formé par de premiers filaments tissés. La couche interne d'endoprothèse (2) comprend un filament épais (21) et une structure de filament fin (22) qui ont des directions de spirale opposées et la même direction d'extension. La structure de filament fin (22) a de multiples anneaux entrelacés (101) agencés en séquence le long de la direction d'extension. Le filament épais (21) pénètre à travers les anneaux entrelacés (101). La couche externe d'endoprothèse (1) est utilisée pour recouvrir la plaque. De plus, la couche interne d'endoprothèse (2) formée par le filament épais s'étendant en spirale (21) et la structure de filament fin (22) a d'excellentes propriétés mécaniques, une grande force radiale, une résistance à la déformation et une flexibilité élevée, et peut ainsi étendre en continu des vaisseaux sanguins rétrécis. De plus, étant donné que le filament épais (21) pénètre à travers les anneaux entrelacés (101) de la structure de filament fin (22), la structure de filament fin (22) peut également fournir un espace de déplacement pour le filament épais (21) pendant le pliage tout en fixant le filament épais (21), et peut également empêcher la déformation de l'endoprothèse provoquée par un déplacement excessif du filament épais (21).
PCT/CN2022/104018 2021-07-14 2022-07-06 Endoprothèse médicale WO2023284595A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110796298.1 2021-07-14
CN202110796298.1A CN115624423A (zh) 2021-07-14 2021-07-14 医疗支架

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WO2023284595A1 true WO2023284595A1 (fr) 2023-01-19

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5849037A (en) * 1995-04-12 1998-12-15 Corvita Corporation Self-expanding stent for a medical device to be introduced into a cavity of a body, and method for its preparation
US5957974A (en) * 1997-01-23 1999-09-28 Schneider (Usa) Inc Stent graft with braided polymeric sleeve
US20010003801A1 (en) * 1997-01-31 2001-06-14 Thomas O. Hoover Stent for treating pathological body vessels
JP2001212246A (ja) * 2000-02-07 2001-08-07 Shimadzu Corp 生体内分解性ステント
WO2012110414A1 (fr) * 2011-02-14 2012-08-23 Acandis Gmbh & Co Kg Dispositif médical comprenant un treillis métallique expansible
CN102727332A (zh) * 2011-04-14 2012-10-17 朝日英达科株式会社 支架
US20150320542A1 (en) * 2014-05-08 2015-11-12 Secant Medical, Inc. Composite lumen with reinforcing textile and matrix
CN107427377A (zh) * 2015-01-12 2017-12-01 微仙美国有限公司 支架
JP2018000794A (ja) * 2016-07-07 2018-01-11 ニプロ株式会社 ステント
CN109890323A (zh) * 2016-10-27 2019-06-14 急速医疗有限公司 编织丝线管腔内装置
CN112386364A (zh) * 2020-11-10 2021-02-23 苏州中天医疗器械科技有限公司 混合编织支架

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5849037A (en) * 1995-04-12 1998-12-15 Corvita Corporation Self-expanding stent for a medical device to be introduced into a cavity of a body, and method for its preparation
US5957974A (en) * 1997-01-23 1999-09-28 Schneider (Usa) Inc Stent graft with braided polymeric sleeve
US20010003801A1 (en) * 1997-01-31 2001-06-14 Thomas O. Hoover Stent for treating pathological body vessels
JP2001212246A (ja) * 2000-02-07 2001-08-07 Shimadzu Corp 生体内分解性ステント
WO2012110414A1 (fr) * 2011-02-14 2012-08-23 Acandis Gmbh & Co Kg Dispositif médical comprenant un treillis métallique expansible
CN102727332A (zh) * 2011-04-14 2012-10-17 朝日英达科株式会社 支架
US20150320542A1 (en) * 2014-05-08 2015-11-12 Secant Medical, Inc. Composite lumen with reinforcing textile and matrix
CN107427377A (zh) * 2015-01-12 2017-12-01 微仙美国有限公司 支架
JP2018000794A (ja) * 2016-07-07 2018-01-11 ニプロ株式会社 ステント
CN109890323A (zh) * 2016-10-27 2019-06-14 急速医疗有限公司 编织丝线管腔内装置
CN112386364A (zh) * 2020-11-10 2021-02-23 苏州中天医疗器械科技有限公司 混合编织支架

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