WO2023233374A1 - Ensembles endoprothèses et procédé de fabrication - Google Patents

Ensembles endoprothèses et procédé de fabrication Download PDF

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Publication number
WO2023233374A1
WO2023233374A1 PCT/IB2023/055698 IB2023055698W WO2023233374A1 WO 2023233374 A1 WO2023233374 A1 WO 2023233374A1 IB 2023055698 W IB2023055698 W IB 2023055698W WO 2023233374 A1 WO2023233374 A1 WO 2023233374A1
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WO
WIPO (PCT)
Prior art keywords
strut
segment
stent
perimeter
transverse
Prior art date
Application number
PCT/IB2023/055698
Other languages
English (en)
Inventor
Elad Einav
Amir Kraitzer
Original Assignee
Medibrane Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medibrane Ltd filed Critical Medibrane Ltd
Publication of WO2023233374A1 publication Critical patent/WO2023233374A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives

Definitions

  • the present invention relates to medical stent devices and assemblies comprising metal stents and covering materials (including fabrics) attached thereto, along with methods for their manufacture and assembly.
  • the present invention is suitable for use in medical applications as a sutureless stent graft.
  • a stent is a metal or polymer tube inserted into the lumen of an anatomic vessel or duct to keep the passageway open.
  • stents may be used in the vascular system, urogenital tract and bile duct, as well as in a variety of other applications in the body.
  • Endovascular stents have become widely used for the treatment of stenosis, strictures, and aneurysms in various blood vessels. These devices are implanted within the vessel to open and/or reinforce collapsing or partially occluded sections of the vessel.
  • Stents are generally open ended and are radially expandable between a generally unexpanded insertion diameter and an expanded implantation diameter which is greater than the unexpanded insertion diameter. Stents are often flexible in configuration, which allows them to be inserted through and conform to tortuous pathways in the blood vessel. The stent is generally inserted in a radially compressed state and expanded either through a self-expanding mechanism, or through the use of balloon catheters.
  • a stent and a graft are tubular devices which may be formed of a variety of material, including textile and non-textile fabric materials and other covering materials.
  • Such a composite medical device provides additional support for blood flow through weakened sections of a blood vessel.
  • the use of a stent/graft combination is becoming increasingly important because the combination not only effectively allows the passage of blood therethrough, but also ensures the implant will remain open and stable.
  • stent grafts with full bonding can require high radial forces to compress the stent for insertion into a catheter, and this can be exacerbated by resistance forces, for example, to longitudinal extension when the stent is compressed.
  • stent grafts with full circumferential bonding can experience non-optimal or uncontrolled wrinkling of the graft fabric when the stent is compressed and/or have a higher likelihood of kinking or twisting that can ‘choke’ the lumen of the stent- supported vessel.
  • stent assemblies having fabric coverings attached when the stent is in an unconstrained, e.g., expanded, state can exhibit excessive fabric wrinkling when constrained to a reduced-diameter state.
  • a stent assembly comprises: (a) a stent formed by a network of strut-segments and comprising an internal surface and an external surface, each strut-segment having a transverse cross-section defining a respective shape; (b) a fabric material covering a given part of the stent on a first surface selected from the internal surface and the external surface; and (c) a polymer binder.
  • the covering by the fabric material is such that the fabric material is bonded to a respective transverse portion of a perimeter of each strut-segment within the given part by the polymer binder.
  • the respective transverse portion comprises at least 30%, or at least 35%, or at least 40%, or at least 45%, or at least 50%, of the respective perimeter of each strut-segment having a transverse cross-section defining a rounded shape, and at least 55%, or at least 60%, or at least 65%, or at least 70%, of the respective perimeter of each strut-segment having a transverse cross-section defining a prismatic shape.
  • the fabric material additionally covers the given part on a second surface, such that both the internal surface and the external surface of the given part are covered, and/or (ii) the respective transverse portion comprises at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, of the respective perimeter of each strut-segment having a transverse crosssection defining a rounded shape, and at least 80%, or at least 85%, or at least 90%, or at least 95%, or all of the respective perimeter of each strut-segment having a transverse cross-section defining a prismatic shape.
  • each strut-segment within the given area can have a transverse cross-section defining a rounded shape, and/or that the respective transverse portion comprises at least 40% of the respective perimeter of each strut-segment. In some embodiments, it can be that each strut-segment within the given area has a transverse cross-section defining a prismatic shape, and/or that the respective transverse portion comprises at least 60% of the respective periphery of each strut-segment.
  • each strut-segment within the given area has a transverse cross-section defining a rounded shape, and/or that the respective transverse portion comprises at least 80% of the respective perimeter of each strut-segment. In some embodiments, it can be that each strut-segment within the given area has a transverse cross-section defining a prismatic shape, and/or that the respective transverse portion comprises at least 90% of the respective perimeter of each strut-segment.
  • At least one respective transverse portion can be discontinuous. In some embodiments, all of the respective transverse portions can be discontinuous.
  • the stent assembly can additionally comprise a coupling agent mediating between the polymer binder and the respective transverse portions.
  • the coupling agent can be effective to create a covalent bond between the polymer binder and the respective transverse portions.
  • the stent assembly can additionally comprise a coupling agent mediating between the polymer binder and the fabric material.
  • the coupling agent can be effective to create a covalent bond between the polymer binder and the fabric material.
  • a method for assembling a stent assembly.
  • the method comprises: (a) providing a stent that comprises an internal surface and an external surface, and that is formed by a network of strut-segments, each strut-segment having a transverse cross-section defining a respective shape; (b) coating, with a polymer binder, a respective transverse portion of a perimeter of each strut-segment within a given part of the stent on a first surface selected from the internal surface and the external surface, wherein the coated respective transverse portion comprises at least 30%, or at least 35%, or at least 40%, or at least 45%, or at least 50%, of the respective perimeter of each strut-segment having a transverse crosssection defining a rounded shape, and at least 55%, or at least 60%, or at least 65%, or at least 70%, of the respective perimeter of each strut-segment having a transverse cross-section defining a rounded shape, and
  • the method can additionally comprise: (i) further coating, with the polymer binder, the respective transverse portion of the perimeter of each strut-segment within the given part of the stent on a second surface, wherein the respective transverse portion comprises at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, of the respective perimeter of each strut-segment having a transverse cross-section defining a rounded shape, and at least 80%, or at least 85%, or at least 90%, or at least 95%, or all of the respective perimeter of each strut-segment having a transverse cross-section defining a prismatic shape, and/or (ii) additionally engaging a fabric material with the further-coated respective transverse portions so as to bond the fabric material thereto and thereby additionally cover the given part of the stent on said second surface.
  • each strut-segment within the given area can have a transverse cross-section defining a rounded shape, and/or that the respective transverse portion comprises at least 40% of the respective perimeter of each strut-segment. In some embodiments, it can be that each strut-segment within the given area has a transverse cross-section defining a prismatic shape, and/or that the respective transverse portion comprises at least 60% of the respective periphery of each strut-segment.
  • each strut-segment within the given area has a transverse cross-section defining a rounded shape, and/or that the respective transverse portion comprises at least 80% of the respective perimeter of each strut-segment. In some embodiments, it can be that each strut-segment within the given area has a transverse cross-section defining a prismatic shape, and/or that the respective transverse portion comprises at least 90% of the respective perimeter of each strut-segment.
  • At least one respective transverse portion can be discontinuous. In some embodiments, all of the respective transverse portions can be discontinuous.
  • the coating can include applying a coupling agent between the polymer binder and the respective transverse portions to form a covalent bond therebetween.
  • the further coating can include applying a coupling agent between the polymer binder and the respective transverse portions to form a covalent bond therebetween.
  • the engaging can include applying a coupling agent to mediate between the polymer binder and the fabric material to form a covalent bond therebetween.
  • the additionally engaging can include applying a coupling agent to mediate between the polymer binder and the fabric material to form a covalent bond therebetween.
  • Fig. 1A is a schematic illustration of a stent scaffold, according to embodiments of the present invention.
  • Fig. IB shows a detail of Fig. 1A, showing several strut segments, according to embodiments of the present invention.
  • Fig. 1C shows a transverse cross-section of a strut segment, according to embodiments of the present invention.
  • Fig. 2 shows a stent graft with a fabric material covering both interior and exterior surfaces of the stent, with a given area of the stent identified, according to embodiments of the present invention.
  • Fig. 3A shows a cross-sectional view of a strut segment having a rounded shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on a single surface, according to embodiments of the present invention.
  • Figs. 3B and 3C show respective cross-sectional views of a strut segment having a rounded shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on two surfaces, Fig. 3C illustrating an example wherein the respective fabrics of the two surfaces are in contact with each other, according to embodiments of the present invention.
  • Fig. 4A shows a cross-sectional view of a strut segment having a rounded shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on a single surface, according to embodiments of the present invention.
  • Figs. 4B and 4C show respective cross-sectional views of a strut segment having a rounded shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on two surfaces, according to embodiments of the present invention, Fig. 4C illustrating an example wherein the respective fabrics of the two surfaces are in contact with each other, according to embodiments of the present invention.
  • Fig. 5A shows a cross-sectional view of a strut segment having a prismatic shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on a single surface, according to embodiments of the present invention.
  • Figs. 5B and 354C show respective cross-sectional views of a strut segment having a prismatic shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on two surfaces, Fig. 5C illustrating an example wherein the respective fabrics of the two surfaces are in contact with each other, according to embodiments of the present invention.
  • Fig. 6A shows a cross-sectional view of a strut segment having a prismatic shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on a single surface, according to embodiments of the present invention.
  • Figs. 6B and 6C show respective cross-sectional views of a strut segment having a prismatic shape, with fabric material bonded to a transverse portion of the perimeter of the strut segment on two surfaces, according to embodiments of the present invention.
  • Figs. 7A and 7B illustrate respective stent scaffolds wherein struts have a prismatic cross-sectional shape, curved with the contour of the stent, according to embodiments of the present invention.
  • Fig. 7C is a schematic cross-sectional view of a stent scaffold wherein struts have a prismatic cross-sectional shape, curved with the contour of the stent, according to embodiments of the present invention.
  • Fig. 7D shows a cross-sectional view of a strut segment having a prismatic shape, curved with the contour of the stent, with fabric material bonded to a transverse portion of the perimeter of the strut segment on a single surface, according to embodiments of the present invention.
  • Figs. 8A and 8B are schematic illustrations of cross-sections of exemplary fabric-covered struts of stent assemblies according to embodiments of the present invention.
  • Figs. 8C and 8D are schematic illustrations of alternative structures of fabric layers, according to embodiments of the present invention.
  • Fig. 8E schematically illustrates an impermeable component of a fabric layer entering one or more permeable layers, according to embodiments of the present invention.
  • Figs. 9 and 10 show flowcharts of methods and method steps for assembling a stent assembly, according to embodiments of the present invention.
  • Subscripted reference numbers e.g., 10i
  • letter-modified reference numbers e.g., 100a
  • 10i is a single appearance (out of a plurality of appearances) of element 10
  • 100a is a single appearance (out of a plurality of appearances) of element 100.
  • stent assembly means an assembly of a medical stent and a fabric cover, sleeve or attachment, attached to the struts of the stent.
  • a stent assembly can be what is commonly called a stent graft.
  • a stent assembly can additionally include materials used in the assembly, such as, for example, primers, coatings, binders and polymers or elastomers.
  • bonding can be used to mean a process of joining using any one or more of: applying an adhesive binder, e.g., by painting it onto a surface of a stent strut; applying heat; and applying pressure.
  • the bonding can be carried out by applying a binder to a strut and then engaging the fabric, or by engaging the fabric and then applying the binder. Either approach can be practiced in any of the embodiments disclosed herein.
  • the bonding or adhesion is chemical in nature, e.g., when the binder and fabric comprise materials which form adhesive chemical bonds therebetween.
  • the bonding or adhesion is mechanical in nature, e.g., when a mechanical interlock is achieved, such as when a binder enters the pores of a porous fabric.
  • the bonding or adhesion can achieve a combination of chemical and mechanical adhesion. All of these cases can be implemented in accordance with any of the embodiments disclosed herein.
  • covering material and ‘fabric material’ (‘fabric) are used interchangeably throughout this disclosure and in the claims appended thereto except where fabric is modified by ‘woven’ or ‘porous’ and the like’.
  • a covering material or, equivalently, can include, and not exhaustively a fabric material, whether woven or not, or a non-fabric material, such as an elastomeric material, or any permeable or impermeable deployed as a covering material (or ‘graft’) for a stent.
  • a stent assembly comprises a stent and a porous fabric material.
  • a stent assembly comprises a stent and a non-porous fabric, which can be liquid-impermeable.
  • the fabric/covering material can be in the form of a sheet or a sleeve, e.g., a cylinder.
  • a stent assembly comprises a stent formed by a network of strut-segments.
  • the stent generally manifests as a hollow tube or other three- dimensional structure, and thus includes an internal surface and an external surface.
  • Each strut-segment has a transverse cross-section defining a respective shape.
  • sufficient adhesion of a fabric material to a stent scaffold is achieved by coating and covering a tangential section of a strut perimeter.
  • substantially more robust adhesion is achievable by applying a coating, and engaging therewith the fabric material covering, with a larger transverse portion of the perimeter of the strut.
  • struts or strut- segments having prismatic cross-sectional shapes generally require a larger transverse portion to be coated and covered than struts or strut-segments having rounded shapes, e.g., to achieve a desired level of robustness of adhesion.
  • a stent scaffold 101 (stent without fabric cover) is formed by or from a network of strutsegments 110.
  • An exemplary strut-segment 110 has a transverse cross-section having a rounded shape, i.e., the transverse cross-section has a perimeter 205 with a rounded shape.
  • Stent-segment cross-sections can have varied shapes, which are generally categorizable as being rounded or prismatic.
  • FIG. 2 shows a stent assembly 100 (covered stent, or stent graft) according to embodiments, and identifies a given area 121 that includes a region of the stent 101.
  • a given area 121 can be selected for purposes of defining a set of features or characteristics of interest and can include any area comprising at least two strut-segments 110.
  • a given area 121 can be characterized by all the strut-segments 110 therewithin having the same cross- sectional shapes.
  • Fig. 2 shows a non-limiting example of shape, size and location of a given area 121 on a stent assembly 100, and in other examples, a given area can be larger or smaller, of any practical shape, and located anywhere on the stent assembly 100.
  • a stent assembly 100 as illustrated in Fig. 2, comprises the stent 101, a polymer binder 104 applied to strut-segments 110 of the stent 101 and a fabric material 106 covering (at least) a given part 121 of the stent 101 on at least a first surface selected from the internal surface and the external surface.
  • the fabric material 106 covers a surface of a given area 121 of the stent 101 on either or both of the surfaces 152, 151 of the stent 101
  • the fabric material 106 is bonded to each strutsegment 110 within the given part 121 by a polymer binder 104.
  • the fabric material 106 is bonded by the polymer binder 104 to a respective transverse portion 210 of the perimeter 205 of each of the strut-segments 110 in the given area 121, as illustrated in Fig. 3A.
  • Fig. 3A is a schematic cross-sectional view of a strut-segment 110 having a circular shape, i.e., a rounded shape, as in Fig. 1C.
  • the polymer binder coating 104 and fabric material 106 are applied to and engaged with, respectively, to a transverse portion 210 of the perimeter 205 of the stent-segment 110 on a single surface of the stent (either the external surface 152 or the internal surface 151), as indicated by arrow 800.
  • the arc traversed by the transverse portions 210 is at least 30%, or at least 35%, or at least 40%, or at least 45%, or at least 50%, of the perimeter 205 - of strut-segments 110 having a transverse cross-section defining a rounded shape. In some embodiments, the arc traversed by the transverse portions 210 is at least 40% of the perimeter 205. In embodiments, all of the strut-segments 110 in a given area 121 have the same transverse cross-section.
  • Fig. 3B illustrates the same or similar circular/rounded strut-segment 110, with both surfaces 152, 151 of the stent 101 in the given area 121 coated with a respective layer of the polymer binder 104A, 104B and covered on both surfaces 152, 151 by a respective fabric material 106A, 106B.
  • the transverse portion 210 is discontinuous, as it includes two different and non-contiguous transverse portions 210 of the perimeter 205. In some embodiments, all of the transverse portions 210 within the given area 121 are discontinuous. In other examples, not illustrated, the coating with the polymer binder can be done to one continuous transverse portion 210.
  • the sum of the one or more arcs traversed by the transverse portion 210 is at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, of the perimeter 205 - of strut-segments 110 having a transverse cross-section defining a rounded shape.
  • the total of the one or more arcs traversed by the transverse portions 210 are at least 80% of the perimeter 205.
  • Fig. 3C shows a non-limiting example in which the two fabric materials 106A, 106B are in contact with each other, at least in proximity to the strut segment 110, such that the transverse portion 210 is coated along substantially all of its perimeter.
  • Figs. 4A and 4B are similar to Figs. 3 A and 3B, respectively, but relate to strut-segments 110 having an oval or elliptical cross sectional shape rather than the circular shape of Figs. 3 A and 3B.
  • the ratios of the transverse portion 210 relative to the perimeter 205 is the same as or similar to in the example of Figs. 3A and 3B based on both shapes being rounded shapes.
  • Fig. 4C shows a non-limiting example in which the two fabric materials 106A, 106B are in contact with each other, at least in proximity to the strut segment 110, such that the transverse portion 210 is coated along substantially all of its perimeter.
  • Figs. 5A, 5B, 6A, and 6B relate to strut-segments 110 having prismatic cross- sectional shapes.
  • the transverse portion 210 of prismatic-shaped strut-segments comprises a larger proportion of the perimeter than does the transverse portion 210 of rounded-shaped strut segments.
  • 5A and 6A is at least 55%, or at least 60%, or at least 65%, or at least 70%, of the perimeter 205 - of the strut-segments 110 in the given area 121 having a transverse cross-section defining a prismatic shape.
  • the aggregate coverage proportion of the transverse portions 210 when the given area 121 includes strut- segments covered on both the external and internal surfaces 152, 151, as illustrated in Figs. 5B and 6B, is at least 80%, or at least 85%, or at least 90%, or at least 95%, or at least 70%, of the perimeter 205 - of the strut-segments 110 having a transverse crosssection defining a prismatic shape.
  • Figs. 5C and 6C show respective non-limiting examples in which the two fabric materials 106A, 106B are in contact with each other, at least in proximity to the strut segment 110, such that the respective transverse portion 210 is coated along substantially all of its perimeter.
  • Figs. 7A, 7B, 7C, and 7D are illustrative of differentiating between strutsegments having a transverse cross-section defining a rounded shape and strutsegments having a transverse cross-section defining a prismatic shape.
  • Figs. 7A and 7B are illustrative examples of stents whose struts have ‘curved prismatic shapes’, i.e., are curved, but not necessarily rounded. The distinction is explained in Fig.
  • a strut cross-section has a radius r that is equal to or greater than the radius of the stent 100
  • the strut 102 can be considered as prismatic for the purpose of determining a minimum proportion for a transverse portion 210 (relative to the perimeter 205), e.g., for desired robustness of adhesion of the fabric material 106.
  • the strut 102 can be considered as rounded for the purpose of determining a minimum proportion for a transverse portion 210 (relative to the perimeter 205), e.g., the lower minimum ratios discussed above for rounded strut shapes that are sufficient to achieve the desired robustness of adhesion of the fabric material 106 to the strutsegments 110.
  • FIG. 7D shows an illustrative, non-limiting example, in transverse cross-section, of such a strut-segment 110 and the requisite costing (by binder 104) and covering (by fabric 106) over the larger transverse portion 210 of a prismaticshaped strut-segment.
  • Figs. 8A and 8B show a more detailed view of the structure of a stent assembly 100.
  • a strut-segment 110 is treated with a coupling agent 103 before coating with polymer binder 104.
  • the coupling agent 103 mediating between the polymer binder 104 and the respective transverse portion 210 is effective to create a covalent bond between the polymer binder 104 and the respective transverse portion 210.
  • Fig. 8B shows another non-limiting example in which a second coupling agent 205 mediating between the polymer binder 104 and the fabric material 106 is effective to create a covalent bond between the polymer binder 104 and the fabric material 106.
  • the second coupling agent 205 may or may not be the same coupling agent as coupling agent 203.
  • Figs. 8C and 8D show further detail of the fabric material 106 according to examples in which the fabric material comprising multiple layers of material.
  • Fig. 8C shows an example in which the fabric material 106 comprises a substantially impermeable layer 106A, comprising, for example, a non-woven fabric, and a permeable or porous layer 106B, comprising, for example, a woven or expanded fabric.
  • the porous layer 106B can be disposed ‘above’ or ‘below’ the impermeable layer 106A, i.e., relative to the strut segment 110.
  • Fig. 8C shows an example in which the fabric material 106 comprises a substantially impermeable layer 106A, comprising, for example, a non-woven fabric, and a permeable or porous layer 106B, comprising, for example, a woven or expanded fabric.
  • the porous layer 106B can be disposed ‘above’ or ‘below’ the impermeable layer 106A,
  • the fabric material 106 comprises a substantially impermeable layer 106A, comprising, for example, a non-woven fabric, and two permeable or porous layers 106B, comprising, for example, a woven or expanded fabric.
  • the respective porous layers 106B are disposed ‘above’ and ‘below’ the impermeable layer 106A, i.e., relative to the strut segment 110.
  • the material of the impermeable layer can, upon application of heat and/or pressure, flow into and through pores or other spaces in the one or more permeable layers 106B, and thereby improve bonding of the fabric layer 106 to the layers below, including the strut segment 110.
  • a method is disclosed assembling a stent assembly. As illustrated by the flowchart in Fig. 9, the method comprises at least the following steps SOI, S02 and S03:
  • Step SOI providing a stent 101 formed by a network of strut- segments 110, each strut-segment 110 having a transverse cross-section defining a respective shape, e.g., prismatic or rounded. Any of the stents 101 disclosed herein are suitable for use in Step SOI.
  • Step S02 coating a transverse portion 210 of a perimeter 205 of each strutsegment 110 within a given part 121 of the stent 101 with a polymer binder 104, on a first surface selected from the internal surface 151 and the external surface 152.
  • the coated respective transverse portion 210 comprises at least 30%, or at least 35%, or at least 40%, or at least 45%, or at least 50%, of the respective perimeter 205 of each strut-segment 110 having a transverse cross-section defining a rounded shape, and at least 55%, or at least 60%, or at least 65%, or at least 70%, of the respective perimeter 210 of each strut-segment 110 having a transverse cross-section defining a prismatic shape.
  • each strut-segment 110 within the given area 121 has a transverse cross-section defining a rounded shape
  • the respective transverse portion 210 comprises at least 40% of the respective perimeter 205 of each strutsegment 110.
  • each strut-segment 110 within the given area 121 has a transverse cross-section defining a prismatic shape, and the respective transverse portion 210 comprises at least 60% of the respective perimeter 205 of each strutsegment 110.
  • at least one of the transverse portions 210 in the given area 121 is discontinuous, and in some embodiments all of the transverse portions 210 in the given area 121 are discontinuous.
  • Step S02 includes applying a coupling agent 103 between the polymer binder 104 and the respective transverse portions 210 to form a covalent bond therebetween.
  • Step S03 engaging a fabric material 106 with the coated respective transverse portions 210 so as to bond the fabric material 106 thereto and thereby cover the given part 121 of the stent 101 on the first surface.
  • Step S03 includes applying a coupling agent 103 to mediate between the polymer binder 104 and the fabric material 106 to form a covalent bond therebetween.
  • the method includes two additional steps S04 and SOS, as illustrated in Fig. 10:
  • Step S04 further coating the transverse portion 210 of the perimeter 205 of each strut-segment 110 within the given part 121 of the stent 110 on a second surface.
  • the respective transverse portion 210 comprises at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%, of the respective perimeter 205 of each strut-segment 110 having a transverse cross-section defining a rounded shape, and at least 80%, or at least 85%, or at least 90%, or at least 95%, of the respective perimeter 205 of each strut-segment having a transverse cross-section defining a prismatic shape.
  • each strut-segment 110 within the given area 121 has a transverse cross-section defining a rounded shape, and the respective transverse portion 210 comprises at least 80% of the respective perimeter 205 of each strutsegment. In some embodiments, each strut-segment 110 within the given area 121 has a transverse cross-section defining a prismatic shape, and the respective transverse portion 210 comprises at least 90% of the respective perimeter 205 of each strutsegment.
  • Step S04 includes applying a coupling agent 103 between the polymer binder 104 and the respective transverse portions 210 to form a covalent bond therebetween. In some embodiments, Step SOS includes applying a coupling agent 103 to mediate between the polymer binder 104 and the fabric material 106, e.g., the fabric material covering the second stent surface, to form a covalent bond therebetween.
  • Step SOS additionally engaging a fabric material 106 with the further-coated respective transverse portions 210 so as to bond the fabric material 106 thereto and thereby additionally cover the given part 121 of the stent 101 on said second surface
  • each of the verbs, “comprise”, “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.
  • the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise.
  • the term “a marking” or “at least one marking” may include a plurality of markings.

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

Abstract

L'invention porte sur un ensemble endoprothèse qui comprend une endoprothèse formée par un réseau de segments d'entretoise et comprenant une surface interne et une surface externe, chaque segment d'entretoise ayant une section transversale définissant une forme respective, un matériau de tissu recouvrant une partie donnée de l'endoprothèse sur une première surface sélectionnée à partir de la surface interne et de la surface externe, et un liant polymère. Le revêtement par le matériau de tissu est tel que le matériau de tissu est lié à une partie transversale respective d'un périmètre de chaque segment d'entretoise à l'intérieur de la partie donnée par le liant polymère, et la partie transversale respective comprend au moins 40 % du périmètre respectif de chaque segment d'entretoise ayant une section transversale définissant une forme arrondie, et au moins 60 % du périmètre respectif de chaque segment d'entretoise ayant une section transversale définissant une forme prismatique.
PCT/IB2023/055698 2022-06-03 2023-06-02 Ensembles endoprothèses et procédé de fabrication WO2023233374A1 (fr)

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US63/348,535 2022-06-03

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6004348A (en) * 1995-03-10 1999-12-21 Impra, Inc. Endoluminal encapsulated stent and methods of manufacture and endoluminal delivery
EP3326581A1 (fr) * 2015-07-23 2018-05-30 Japan Lifeline Co., Ltd. Endoprothèse couverte
US20200015987A1 (en) * 2018-07-12 2020-01-16 Medibrane Ltd. Stent assembly and method of manufacturing

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6004348A (en) * 1995-03-10 1999-12-21 Impra, Inc. Endoluminal encapsulated stent and methods of manufacture and endoluminal delivery
EP3326581A1 (fr) * 2015-07-23 2018-05-30 Japan Lifeline Co., Ltd. Endoprothèse couverte
US20200015987A1 (en) * 2018-07-12 2020-01-16 Medibrane Ltd. Stent assembly and method of manufacturing

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