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WO2025172962A1 - Stent coronaire au cobalt-chrome à élution d'évérolimus avec des polymères biodégradables abluminaux - Google Patents

Stent coronaire au cobalt-chrome à élution d'évérolimus avec des polymères biodégradables abluminaux

Info

Publication number
WO2025172962A1
WO2025172962A1 PCT/IB2025/051681 IB2025051681W WO2025172962A1 WO 2025172962 A1 WO2025172962 A1 WO 2025172962A1 IB 2025051681 W IB2025051681 W IB 2025051681W WO 2025172962 A1 WO2025172962 A1 WO 2025172962A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
everolimus
coating
cell
polymers
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/IB2025/051681
Other languages
English (en)
Inventor
Bhavesh Pastagia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innvolution Healthcare Pvt Ltd
Original Assignee
Innvolution Healthcare Pvt 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 Innvolution Healthcare Pvt Ltd filed Critical Innvolution Healthcare Pvt Ltd
Publication of WO2025172962A1 publication Critical patent/WO2025172962A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61F2/82—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 sheets 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 sheets 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D167/00—Coating compositions based on polyesters obtained by reactions forming a carboxylic ester link in the main chain; Coating compositions based on derivatives of such polymers
    • C09D167/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
    • 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 sheets 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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A61L2300/604—Biodegradation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Definitions

  • BMS Bare metal stents
  • BMS Bare metal stents
  • DES Drug-eluting stents
  • RES artery re-narrowing
  • DES can also pose risks, such as late stent thrombosis.
  • biodegradable polymers that reduces systemic side effects, improves endothelial healing, enhance biocompatibility, optimise drug retention and target drug release to the bloodstream.
  • an Everolimus-eluting cobalt chromium coronary stent with a biodegradable polymer based coating disposed on the abluminal surface comprises a mixture of Everolimus and two biodegradable polymers.
  • the polymers are biodegradable ensuring controlled, monodirectional release of Everolimus drug over time.
  • the coating is spray-coating technique on the abluminal surface of the stent when the stent is in crimped state.
  • the length of the sent varies from 8 mm to 48 mm.
  • the polymers comprise poly L-lactide (PLLA), poly lactic-co-glycolic acid (PLGA), or a combination thereof.
  • PLLA poly L-lactide
  • PLGA poly lactic-co-glycolic acid
  • the stent is of open cell configuration.
  • the number of cells of the open cell configuration are one of 6, 8 and 10.
  • the cell diameter of a 6-cell stent ranges between 2 mm to 3 mm.
  • the cell diameter of an 8-cell stent ranges between 3 mm to 4.5 mm.
  • the cell diameter of a 10-cell stent ranges between 4 mm to 4.5 mm.
  • the mixture ratio of Everolimus and the one or more polymers comprises 63.58% and 36.42% respectively.
  • the disclosure aims to develop a novel, biodegradable, polymer-based Everolimus-eluting stent with an asymmetric coating, delivering the drug solely to the abluminal surface.
  • the process involves mixing Everolimus with biodegradable polymers to create a solution that is then spray-coated onto the stent when it is in crimped state. The coating is applied on the abluminal surface.
  • This asymmetric coating strategy minimizes polymer usage, reduces interaction with the bloodstream, and improves drug retention, thereby limiting potential adverse effects associated with polymers.
  • the application of the drug-polymer mixture via spray-coating after the crimping process offers several technical advantages. This approach minimizes drug loss during the crimping process, enhancing drug retention and ensuring a consistent therapeutic dose. Additionally, coating after crimping enhances the biocompatibility of the stent by minimizing polymer exposure to the patient's vasculature. This strategy also increases flexibility in stent design, allowing for a wider range of stent geometries and configurations. Furthermore, coating after crimping simplifies the manufacturing process, reducing the need for complex coating procedures and specialized equipment.
  • Spray-coating in the crimped state offers further benefits in terms of coating integrity and performance. It helps reduce coating cracking or delamination, which can occur during stent expansion. This improved coating retention ensures consistent drug release and minimizes the risk of polymer particles detaching from the stent. Moreover, coating in the crimped state reduces the likelihood of stent strut deformation, as the struts are already deformed during the crimping process. This approach also minimizes coating webbing between stent struts, promoting more even drug release and preventing uneven drug distribution. In summary, coating after crimping results in improved coating retention, reduced coating cracking, and more even drug release, contributing to the overall efficacy and safety of the stent.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un stent coronaire au cobalt-chrome à élution d'évérolimus comprenant un revêtement à base de polymère biodégradable disposé sur la surface abluminale de celui-ci, le revêtement comprenant un mélange d'évérolimus et d'un ou de plusieurs polymères. Les polymères sont biodégradables, assurant une libération contrôlée monodirectionnelle d'évérolimus au cours du temps.
PCT/IB2025/051681 2024-02-17 2025-02-17 Stent coronaire au cobalt-chrome à élution d'évérolimus avec des polymères biodégradables abluminaux Pending WO2025172962A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202411011164 2024-02-17
IN202411011164 2024-02-17

Publications (1)

Publication Number Publication Date
WO2025172962A1 true WO2025172962A1 (fr) 2025-08-21

Family

ID=96773639

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/051681 Pending WO2025172962A1 (fr) 2024-02-17 2025-02-17 Stent coronaire au cobalt-chrome à élution d'évérolimus avec des polymères biodégradables abluminaux

Country Status (1)

Country Link
WO (1) WO2025172962A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7144422B1 (en) * 2002-11-13 2006-12-05 Advanced Cardiovascular Systems, Inc. Drug-eluting stent and methods of making the same
WO2009061787A1 (fr) * 2007-11-05 2009-05-14 Nanocopoeia, Inc. Dispositifs revêtus et procédé de fabrication de dispositifs revêtus qui réduisent la prolifération de cellules de muscle lisse et l'activité plaquettaire

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7144422B1 (en) * 2002-11-13 2006-12-05 Advanced Cardiovascular Systems, Inc. Drug-eluting stent and methods of making the same
WO2009061787A1 (fr) * 2007-11-05 2009-05-14 Nanocopoeia, Inc. Dispositifs revêtus et procédé de fabrication de dispositifs revêtus qui réduisent la prolifération de cellules de muscle lisse et l'activité plaquettaire

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