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WO2007084549A2 - Endoprothese a elution de medicament avec plaques atherosclerotiques dissolvant une preparation pharmacologique - Google Patents

Endoprothese a elution de medicament avec plaques atherosclerotiques dissolvant une preparation pharmacologique Download PDF

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Publication number
WO2007084549A2
WO2007084549A2 PCT/US2007/001214 US2007001214W WO2007084549A2 WO 2007084549 A2 WO2007084549 A2 WO 2007084549A2 US 2007001214 W US2007001214 W US 2007001214W WO 2007084549 A2 WO2007084549 A2 WO 2007084549A2
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WO
WIPO (PCT)
Prior art keywords
stent
lipid
plaque
solubilizer
detergent
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.)
Ceased
Application number
PCT/US2007/001214
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English (en)
Other versions
WO2007084549A3 (fr
Inventor
Filiberto Zadini
Giorgio Zadini
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Individual
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Individual
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 Individual filed Critical Individual
Publication of WO2007084549A2 publication Critical patent/WO2007084549A2/fr
Publication of WO2007084549A3 publication Critical patent/WO2007084549A3/fr
Priority to US12/024,908 priority Critical patent/US8304383B2/en
Anticipated expiration legal-status Critical
Priority to US12/211,754 priority patent/US20090035348A1/en
Priority to US13/633,704 priority patent/US8697633B2/en
Priority to US13/871,904 priority patent/US20140234398A1/en
Priority to US14/164,648 priority patent/US20140142071A1/en
Ceased legal-status Critical Current

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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • 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
    • 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
    • A61L2300/422—Anti-atherosclerotic agents
    • 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
    • A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
    • A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants

Definitions

  • the invention consists of a drug-eluting arterial stent in which the eluting drug is a lipid/cholesterol dissolving pharmacological compound aimed at the solubilization of the lipid component of the atherosclerotic plaque.
  • Coronary stents are expandable metal tube mesh-like stents of variable length that are placed in the arteries of patients at the site of balloon angioplasty. Stents provide additional support to the wall of the artery after the procedure of angioplasty, aiming at preserving its patency. Stents have shown to decrease the chance of re-narrowing of the arterial lumen. However, despite stent placement, re-stenosis is common. Up to 30%-40% if no more of patients develop re-stenosis in the long term at the site of the stent placement, the re-stenosis process starting just days after the angioplasty procedure.
  • Drug-eluting stents were introduced with the intent to obviate the re-stenosis problem.
  • Drug-eluting stents are stent coated with a thin polymer containing medications aimed at the prevention of re-stenosis of the artery by preventing formation of scar tissue at the site of an angioplasty procedure.
  • the drugs that may be useful in preventing re-stenosis fall in four major categories: antineoplastic, antiproliferative, migration inhibitors, enhanced healing factors.
  • plaque components do not go away from the arterial wall. As a matter of fact, they remain within the arterial wall with their unaltered mass, and, as such, they exert constant pressure toward lumen re-stenosis.
  • a detergent such as a biliary acid
  • a biliary acid when placed in contact with an atherosclerotic plaque is capable of dissolving it in matter of hours.
  • the detergent such as a biliary acid
  • the detergent compound such as deoxycholic acid, literally melts, dissolves the fatty component of the plaque.
  • the dissolved component namely cholesterol, filters out thru the cap into the bloodstream in micro particles.
  • the atherosclerotic plaque dissolving properties of a detergent/lipid solubilizer such as a biliary acid or salt is the subject matter of Applicants US Provisional Patent Application: "Dissolution of Arterial Cholesterol Plaques by Pharmacological Preparation", No. 60/739,143 filed on 11/22/2005.
  • the pharmacological compound with which the drug-eluting stent is coated can be any biliary acid or salt alone or in combination or any precursor or derivative of such bile acid or salt alone or in combination, such as Cholic acid or Chenodeoxycholic acid or Deoxycholic acid or Lithocholic acid Hyodeoxycholic acid or Glycocholic acid or Taurocholic acid.
  • any type of suitable biolog ⁇ cal/biocompatible lipid / cholesterol solubilizer / detergent can be used alone or in combination.
  • Applicants believe that the local elimination /dissolution of the post-angioplasty atherosclerotic plaque lipid component , atherosclerotic plaque which is compressed/fractured by the angioplasty procedure , releases the constant pressure toward re-stenosis exerted when the plaque is compressed, fractured and left with its total mass unaltered. As result of the release of such pressure, it is likely that also scar tissue formation at the plaque site become less probable.
  • a lipid solubilizer such as a Triton compound or a Fatty Acid Bile Acid Conjugate such as Arachidyl amido cholanoic acid known as Aramchol can be used.
  • Fig. 1 is a partially cross sectioned perspective view of a drug-eluting stent coated with a biocompatible detergent in place deployed within the artery, after angioplasty.
  • drug-eluting stent 1 is shown deployed in situ within an artery with atherosclerotic lesions after angioplasty has been carried out.
  • Drug-eluting stent 1 of generally tubular shape is composed of lattice, expandable workframe or structure 2 assembled from a variety of metals such as nitinol, stainless steel or cobalt chromium. Stent 1 is spring like and flexible.
  • Lattice structure 2 of drag-eluting stent 1 is coated with deoxycholic acid 1 ' which has detergent properties.
  • the drug carrier which slowly releases the drug over time can be typically a polymer, although also phosphorylcholine and ceramics could be used in a single or multiple layers fashion.
  • a stent with an eluting sheath could be used , as disclosed in US Patent Application number 10/334,034 "Drug-eluting stent cover and method of use" by Yip Philip S. and Al., filed on December 30, 2002.
  • Such intravascular stent includes an eluting sheath fabricated from a mesh for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel.
  • the eluting sheath is attached to the outside surface area of the stent structure and is fabricated from a mesh designed to expand outwardly in unison with the radial stent expansion.
  • the eluting sheath can be loaded with at least one therapeutic drug for its controlled release.
  • lipid-solubilizer detergent as well as other biocompatible detergents, is capable indeed of passing thru the fibrous cap of the atherosclerotic plaque and capable of attacking the plaque for its dissolution.
  • a lipid solubilizer detergent compound such as the Deoxycholic acid, Cholic acid or Che ⁇ odeoxycholic acid or Lithocholic acid, Hyodeoxycholic acid or Glycocholic acid or Taurocholic acid or a biocompatible a Triton compound or a Fatty Acid Bile Acid Conjugate such as Arachidyl amido cholanoic acid 1 ⁇ literally melts, dissolves the fatty components of the plaque. What is occurring is indeed a delipidizat ⁇ on of the atherosclerotic plaque.
  • Such compounds, which are biological/biocompatible compounds can be classified according to several criteria.
  • Alkyl glycosides which include: -D-glucopyranos ⁇ de,G-D-glucopyranoside, n-octyl-
  • Bile acids which include a very large number of compounds listed elsewhere in this application.
  • Glucamides which include: MEGA-10, MEGA-9, MEGA-8, Deoxy Big CHAP, Big
  • Polyoxyethylenes, monodisperse and polydisperse which include: reduced TRITON®
  • Zwittergents which include: EMPIGEN BB® (n-dodecyl-N,Ndimethylglycine),
  • Ionic Detergents which include: BATC Cetyltrimethylammonium Bromide (CTAB), Molecular Biology Grade Chenodeoxycholic Acid, Free Acid Chenodeoxycholic Acid, Sodium Salt
  • Taurolithocholic Acid, Sodium Salt Tauroursodeoxycholic Acid, Sodium Salt
  • Non-ionic Detergents APO-IO APO-12 Big CHAP
  • NP-40 PROTEIN GRADE® Detergent
  • 10% Solution n-Octanoyl- ⁇ -D-glucosylamine (NOGA) ⁇ -Octanoylsucrose n-Octyl- ⁇ -D-glucopyranos ⁇ de n-Octyl- ⁇ -D-glucopyranoside
  • ULTROL® Grade n-Octyl- ⁇ -D-maltopyranoside
  • ULTROL® Grade n-Octyl- ⁇ -D-thioglycopyranoside
  • TWEEN® 20 Molecular Biology Grade TWEEN® 20, PROTEIN GRADE® Detergent, 10% Solution
  • Pluronic compounds such as F68 i.e. Polaxamer 188; Tween 80 i.e. Polysorbate 80; Triton X 100; Methyl-Butyl Ether known as MBTE; Ethylpropionate known as EP; Sorbitol Anydride Monostearate known as Span; Sorbitan compounds; taurodihydrofusidate, Caprylic and capric mono-diglyceride esters known as Captex; Capmul compounds i.e. mono and d ⁇ - glyceride emulsifiers prepared through the glycerolysis of select fats and oils.
  • Pluronic compounds such as F68 i.e. Polaxamer 188; Tween 80 i.e. Polysorbate 80; Triton X 100; Methyl-Butyl Ether known as MBTE; Ethylpropionate known as EP; Sorbitol Anydride Monostearate known as Span; So
  • Caprol® polyglycerol esters compounds so called PGE's which are generally prepared by esterification of select polyglycerol molecules with fatty acids or by alcoholysis of a vegetable oil with a polyglycerol; fatty acids or fatty acids radicals conjugated with biocompatible/biological solvents: for instance butyric, caproic, caprylic, lauric, myristic, palmitic, stearic, arachidic, behenic, oleic, linoleic, alpha-linolenic, arachidonic, eicosapentaenoic, docosahexaeno ⁇ c acid , euric acid ASB-16 CHAPS CHAPSO DDMAB DDMAU
  • Pluronic compounds such as F68 i.e. Polaxamer 188; Tween 80 i.e. Polysorbate 80; Triton X 100; Methyl-Butyl Ether known as MBTE; Ethylpropionate known as EP; Sorbitol Anydride Monostearate known as Span; Sorbitan compounds; taurodihydrofusidate, Caprylic and capric mono-diglyceride esters known as Captex; Capmul compounds i.e. mono and di- glyceride emulsifiers prepared through the glycerolysis of select fats and oils.
  • Pluronic compounds such as F68 i.e. Polaxamer 188; Tween 80 i.e. Polysorbate 80; Triton X 100; Methyl-Butyl Ether known as MBTE; Ethylpropionate known as EP; Sorbitol Anydride Monostearate known as Span; Sorbit
  • Caprol® polyglycerol esters compounds so called PGE's which are generally prepared by esterification of select polyglycerol molecules with fatty acids or by alcoholysis of a vegetable oil with a polyglycerol
  • d-limonene which can be considered as an organic solvent belonging to the terpenes.
  • Organic solvents are indeed lipid solubilizers, but they are also generally toxic.
  • terpenes which are usually extracted from essential oils of plants, such as the mentioned d-limonene, and certain terpenoids, also of plant origins, as for instance terpenoid constituents of Ginkgo biloba extract:
  • the dissolved main component namely cholesterol aggregates targeted by the lipid solubilizer, will filter out thru the cap into the bloodstream in microscopic or ultramicroscopic particles or at molecular size.
  • Lattice structure 2 of stent 1 can be coated with any biliary acid or salt alone or in combination or any precursor or derivative of such bile acid or salt alone or in combination, such as Cholic acid or Chenodeoxycholic acid or Deoxycholic acid or Lithochol ⁇ c acid or Hyodeoxycholic acid or Glycocholic acid or Taurocholic acid or a FABC such as Arachidyl amido cholanoic acid or any of the above disclosed pharmacological compound belonging to the class of biocompatible detergents/ emulsif ⁇ ers/ surfactants/lipid and cholesterol solubilizers having the property of disaggregating, emulsifying, or dissolving cholesterol aggregates.
  • any biliary acid or salt alone or in combination or any precursor or derivative of such bile acid or salt alone or in combination such as Cholic acid or Chenodeoxycholic acid or Deoxycholic acid or Lithochol ⁇ c acid or Hyodeoxycholic acid or Glycocholic acid or Taurocholic acid or a
  • the eluting drug above disclosed is expected to greatly reduce the chance of re-stenosis.
  • Immunosuppressive agents such as Sirolimus, Tacrolimus, Eveolimus,
  • Antiproliferative agents such as Taxol known as paclitaxel, Actinomycin, Methotrexate angiopeptin, Vincristine, Mitomycin, Statins, CMYC Antisense, Abbot
  • Migration Inhibitors such as Batimistat, Prolyl Hydrossylase, Halofunginone, C- proteinase inhibitors, Probucol;
  • Enhaced Healing Factors such as BCP 671 , VEGF, Estradiols, NO Donor Compounds, EPC antibodies;
  • Collagenase and other collagen degrading enzymes aimed at the lysis of the fibrotic component of the plaque including the plaque fibrous cap;
  • Proteoglycan-degrading enzymes/proteinases aimed at the degradation of the proteoglycan component of the plaque;
  • EDTA aimed at the dissolution of the calcium deposit within the plaque;
  • Lipase directed to the digestion of the fatty component of the plaque enhancing the action of the detergent.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une endoprothèse à élution de médicament pour libérer dans le temps sur site un détergent de procédure d’angioplastie pour la dissolution du composant gras de la plaque athérosclérotique. Le détergent a la capacité de passer à travers le capuchon fibreux et de cibler les composants gras de la plaque. Le détergent a pour but de dissoudre les agrégats de cholestérol de la plaque après procédure d’angioplastie, plaque qui est fracturée, compressée, redistribuée localement par la procédure d’angioplastie mais qui est toujours présente dans la paroi de l’artère après la procédure d’angioplastie. De nombreux autres composés pharmacologiques avec différentes fonctions ciblées peuvent être combinées avec le détergent dans l'endoprothèse comprenant des antinéoplasiques, des immunosuppresseurs, des inhibiteurs de migration, des facteurs de guérison améliorés, du collagène et des enzymes de dégradation du protéoglycane. Il est attendu que cette endoprothèse à élution de médicament, en permettant la dissolution de l’un des composants majeurs de plaques, c.à d. le composant gras, réduise grandement la possibilité d’une resténose.
PCT/US2007/001214 2005-11-22 2007-01-16 Endoprothese a elution de medicament avec plaques atherosclerotiques dissolvant une preparation pharmacologique Ceased WO2007084549A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US12/024,908 US8304383B2 (en) 2005-11-22 2008-02-01 Dissolution of arterial plaque
US12/211,754 US20090035348A1 (en) 2005-11-22 2008-09-16 Dissolution of arterial plaque
US13/633,704 US8697633B2 (en) 2005-11-22 2012-10-02 Dissolution of arterial plaque
US13/871,904 US20140234398A1 (en) 2005-11-22 2013-04-26 Dissolution of Arterial Plaque
US14/164,648 US20140142071A1 (en) 2005-11-22 2014-01-27 Regression of arterial plaque

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US76047106P 2006-01-20 2006-01-20
US60/760,471 2006-01-20

Related Child Applications (3)

Application Number Title Priority Date Filing Date
PCT/US2006/044619 Continuation-In-Part WO2007061820A2 (fr) 2005-11-22 2006-11-16 Dissolution de plaques de cholesterol dans les arteres par des composes pharmacologiques d'une classe specifique
US12/024,908 Continuation-In-Part US8304383B2 (en) 2005-11-22 2008-02-01 Dissolution of arterial plaque
US12/211,754 Continuation-In-Part US20090035348A1 (en) 2005-11-22 2008-09-16 Dissolution of arterial plaque

Publications (2)

Publication Number Publication Date
WO2007084549A2 true WO2007084549A2 (fr) 2007-07-26
WO2007084549A3 WO2007084549A3 (fr) 2007-12-21

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PCT/US2007/001214 Ceased WO2007084549A2 (fr) 2005-11-22 2007-01-16 Endoprothese a elution de medicament avec plaques atherosclerotiques dissolvant une preparation pharmacologique

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102727949A (zh) * 2011-10-25 2012-10-17 上海交通大学附属第一人民医院 药物涂层溶石胆管支架及制备方法
CN102727943A (zh) * 2011-11-14 2012-10-17 上海市第一人民医院 生物可降解聚合物编织的溶石胆管支架及制备方法
CN107405190A (zh) * 2014-12-19 2017-11-28 波士顿科学国际有限公司 具有防移位特征的支架

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030086975A1 (en) * 2001-11-08 2003-05-08 Timothy Ringeisen Method for making a porous Polymeric material
US20030157187A1 (en) * 1996-12-02 2003-08-21 Angiotech Pharmaceuticals, Inc. Compositions and methods for treating or preventing inflammatory diseases
IL123998A (en) * 1998-04-08 2004-09-27 Galmed Int Ltd Conjugates of bile salts and pharmaceutical preparations containing them
US6780849B2 (en) * 2000-12-21 2004-08-24 Scimed Life Systems, Inc. Lipid-based nitric oxide donors
US20050267407A1 (en) * 2002-02-01 2005-12-01 Vascular Designs, Inc. Multi-function catheter and use thereof
US20050163821A1 (en) * 2002-08-02 2005-07-28 Hsing-Wen Sung Drug-eluting Biodegradable Stent and Delivery Means
AU2003287633A1 (en) * 2002-11-08 2004-06-03 Innovational Holdings, Llc Method and apparatus for reducing tissue damage after ischemic injury
US7744645B2 (en) * 2003-09-29 2010-06-29 Medtronic Vascular, Inc. Laminated drug-polymer coated stent with dipped and cured layers
WO2005049105A2 (fr) * 2003-11-10 2005-06-02 Angiotech International Ag Implants medicaux et agents anti-cicatrisation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102727949A (zh) * 2011-10-25 2012-10-17 上海交通大学附属第一人民医院 药物涂层溶石胆管支架及制备方法
CN102727943A (zh) * 2011-11-14 2012-10-17 上海市第一人民医院 生物可降解聚合物编织的溶石胆管支架及制备方法
CN107405190A (zh) * 2014-12-19 2017-11-28 波士顿科学国际有限公司 具有防移位特征的支架
CN107405190B (zh) * 2014-12-19 2019-12-17 波士顿科学国际有限公司 具有防移位特征的支架

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