CA2468254A1 - Therapeutic coating for an intravascular implant - Google Patents

Therapeutic coating for an intravascular implant Download PDF

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Publication number
CA2468254A1
CA2468254A1 CA002468254A CA2468254A CA2468254A1 CA 2468254 A1 CA2468254 A1 CA 2468254A1 CA 002468254 A CA002468254 A CA 002468254A CA 2468254 A CA2468254 A CA 2468254A CA 2468254 A1 CA2468254 A1 CA 2468254A1
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CA
Canada
Prior art keywords
coating
agent
cyclosporine
rapamycin
polymer matrix
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.)
Granted
Application number
CA002468254A
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French (fr)
Other versions
CA2468254C (en
Inventor
Swaminathan Jayaraman
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Individual
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Individual
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Filing date
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Application filed by Individual filed Critical Individual
Publication of CA2468254A1 publication Critical patent/CA2468254A1/en
Application granted granted Critical
Publication of CA2468254C publication Critical patent/CA2468254C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45Mixtures of two or more drugs, e.g. synergistic mixtures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings

Abstract

The invention relates to a coating for an intravascular implant that prevents hyperproliferative vascular disease after a mechanical injury, such as angioplasty. The coating includes first and second agents, with the first agent acting on a calcium independent cellular pathway and the second agent acting on a calcium dependent cellular pathway. In an exemplary embodiment, the first agent is rapamycin and the second agent is cyclosporine A. The agents can be incorporated in a polymeric agent and can be applied either directly to the implant or on top of a primer layer placed on the implant. A
top coat can be applied to the therapeutic coating, if desired.

Claims (20)

1. An intravascular implant coating comprising:
a therapeutically effective amount of a first agent, the first agent acting on a calcium independent cellular pathway; and a therapeutically effective amount of a second agent, the second agent acting on a calcium dependent cellular pathway, wherein the combined amount of the first and second agents treats or prevents hyperproliferative vascular disease.
2. The coating of claim 1 wherein the first agent is a macrolide immunosuppressant.
3. The coating of claim 2 wherein the first agent is rapamycin.
4. The coating of claim 1 wherein the second agent is an IL-2 transcription inhibitor.
5. The coating of claim 4 wherein the second agent is cyclosporine A.
6. The coating of claim 1 wherein the first agent is rapamycin and the second agent is cyclosporine A.
7. The coating of claim 1 wherein the coating contains a higher amount of rapamycin than cyclosporine A.
8. The coating of claim 7 wherein the ratio of rapamycin to cyclosporine A is at least about 0.51.
9. The coating of claim 1 wherein the intravascular implant is selected from the group consisting of balloon catheters, stent, stent grafts, drug delivery catheters, atherectomy devices, filters, scaffolding devices, anastomotic clips, anastomotic bridges, and suture materials.
10. The coating of claim 1 wherein the coating includes a polymer matrix.
11. The coating of claim 1 wherein the polymer matrix includes a resorbable polymer.
12. The coating of claim 1 wherein the intravascular implant includes a primer layer upon which the coating is applied.
13. The coating of claim 12 wherein the primer layer is made of a resorbable polymer.
14. The coating of claim 12 wherein the primer layer is made of a biostable polymer.
15. The coating of claim 1 wherein a top coat is applied over the coating.
16. The coating of claim 15 wherein the top coat is made of a resorbable polymer.
17. An intravascular implant coating comprising:
a therapeutically effective amount of rapamycin; and a therapeutically effective amount of cyclosporine A, wherein the combined amount of rapamycin and cyclosporine A treats or prevents hyperproliferative vascular disease.
18. The coating of claim 17 wherein the coating further includes a resorbable polymer matrix, with the rapamycin and cyclosporine A dispersed within the resorbable polymer matrix.
19. The coating of claim 18 wherein the resorbable polymer matrix is selected from the group consisting of poly-.alpha. hydroxy acids, polyglycols, polytyrosine carbonates, starch, gelatins, cellulose, and blends and co-polymers thereof.
20. The coating of claim 19 wherein the resorbable polymer matrix includes poly-.alpha.
hydroxy acids that are selected from the group consisting of polylactides, polyglycol acids, and blends and co-polymers thereof.
CA2468254A 2001-11-26 2002-11-22 Therapeutic coating for an intravascular implant Expired - Fee Related CA2468254C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/994,253 2001-11-26
US09/994,253 US6641611B2 (en) 2001-11-26 2001-11-26 Therapeutic coating for an intravascular implant
PCT/US2002/037523 WO2003045523A2 (en) 2001-11-26 2002-11-22 Therapeutic coating for an intravascular implant

Publications (2)

Publication Number Publication Date
CA2468254A1 true CA2468254A1 (en) 2003-06-05
CA2468254C CA2468254C (en) 2011-11-01

Family

ID=25540468

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2468254A Expired - Fee Related CA2468254C (en) 2001-11-26 2002-11-22 Therapeutic coating for an intravascular implant

Country Status (9)

Country Link
US (1) US6641611B2 (en)
EP (1) EP1448281B1 (en)
JP (1) JP2005510315A (en)
AT (1) ATE422909T1 (en)
AU (1) AU2002362015B2 (en)
CA (1) CA2468254C (en)
DE (1) DE60231231D1 (en)
DK (1) DK1448281T3 (en)
WO (1) WO2003045523A2 (en)

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