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WO2003008004A1 - Changements de propritetes d'un extenseur pour prevenir la restenose - Google Patents

Changements de propritetes d'un extenseur pour prevenir la restenose Download PDF

Info

Publication number
WO2003008004A1
WO2003008004A1 PCT/SE2002/001388 SE0201388W WO03008004A1 WO 2003008004 A1 WO2003008004 A1 WO 2003008004A1 SE 0201388 W SE0201388 W SE 0201388W WO 03008004 A1 WO03008004 A1 WO 03008004A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
substance
instance
stent according
active
Prior art date
Application number
PCT/SE2002/001388
Other languages
English (en)
Inventor
Oÿvind REITAN
Original Assignee
Reitan Oyvind
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 Reitan Oyvind filed Critical Reitan Oyvind
Publication of WO2003008004A1 publication Critical patent/WO2003008004A1/fr

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
    • 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
    • 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
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/114—Nitric oxide, i.e. NO
    • 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
    • A61L2300/606—Coatings

Definitions

  • the initial result is often very good, but a problem is the occurrence of restenosis in the stented area in about 20 to 30% and therefore represents a clinical problem.
  • the present invention is aiming at solving this problem.
  • Some causes are genetically determined as for instance patients with high levels of cholesterol and also some patients with diabetes. However, a part of the morbidity is caused by the mode of living, as smoking habits, consumption of high caloric diet and reduced physical activity.
  • All cells in the body need blood to perform their different tasks.
  • the blood is transported to the different organs in the body through the blood vessels.
  • the arteries transport the blood f om the heart to the different organs, the veins lead the blood back to the heart.
  • the arteries are mostly affected with narrowings, winch diminish the blood flow to the different organs.
  • vessels exist in all parts of the body all organ systems can be influenced by reduced blood flow, although some organs are more likely to be affected than others.
  • the consequences for the patient depend on the affected area or organ.
  • Some people suffer from reduced blood flow to the legs, to the kidneys to the brain or in the hearts' own vessels, the coronary arteries.
  • the symptoms from the heart depend on the degree of the stenosis.
  • Treatment of stenoses in blood vessels is aimed at restoring the normal blood flow. Apart from pharmacological treatment surgical treatment is an option, most often by making a bypass across the narrowed part of the vessel. Modern treatment also includes the use of catheter-born techniques by the use of the PTCA procedure (percutaneous transluminal catheter angioplasty) when a small balloon at the tip of a catheter dilates the stenotic part of a vessel.
  • PTCA procedure percutaneous transluminal catheter angioplasty
  • stents have been deployed in the narrowed area of the vessel to reinforce the wall of the vessel and to prevent a recoil of the treated area.
  • the stent is mounted on the dilating balloon and when the balloon is inflated, the stent expands and attaches to the wall of the vessel. After the stent has been fixed, it can not be removed.
  • the use of stents in the vessels has been increasing over the years, and depending on the hospital performing the treatment, 40 to 80% of all stenoses will be treated with a stent implantation. The reason is that the primary result is very good and recoil of the vessel is effectively prevented.
  • the vessels in the heart have small diameters and the stents are normally limited to vessels greater than 2- 3mm.
  • a stent is made of metal, either stainless steel or nitinol, an alloy consisting of titan and nickel.
  • Metal in a vessel is a foreign material to the blood and may cause different problems. Two different problems are clearly defined.
  • a stent placed inside a blood vessel represents a foreign material to the body. This will almost always activate the coagulation system and represented a few years ago a clinical problem because of a sudden formation of blood clots inside the stent and a sudden occlusion of the vessel. In addition to the foreign material a stent implantation also led to a minor damage of the wall of the vessel, which also activated the coagulation system. A sudden occlusion is often due to an increased activity of the thrombocytes.
  • new pharmaceuticals like clopidogrel can effectively prevent activation of the thrombocytes and prevent clots to develop and avoid a sudden occlusion of the vessel.
  • the metal is covered by the endothelium, the natural barrier of the vessel against the blood.
  • a greater problem today is the development of in-stent re-stenosis, which means a narrowing of the vessel inside the actual stent-segment.
  • Various studies show that this occurs in about 20 - 30% of all patients receiving a stent resulting in a re-angina in about 10 - 15% of the cases thus representing a clinical problem.
  • Examination of the vessels shows that although the endothelium has covered the metal stent, the tissue continues to grow through the mesh of the stent and fill the lumen of the vessel. The tissue consists to a great part of smooth muscle cells and connective tissue and reduces the diameter of the vessel.
  • a stent can in different ways influence the surrounding tissue. Because a stent nonnally is made of a metal alloy different metal ions can be released and irritate the surrounding cells or galvanic electric current can occur, which also might be of importance.
  • cytostatica cell division inhibitors
  • Radioactive stents have also been constructed, either by making the whole stent radioactive or by making the stent radioactive before the implantation. Irradiation by these stents has reduced in-stent restenosis inside the stent area, but stenosis has been encountered at the in and outlet of the stent where the radiation has been too weak. Even if treatment with radioactivity may prevent growth of new tissue, the problem is the costly and cumbersome handling of the radioactive material, often with long half times.
  • the present invention
  • the present invention aims at solving the problem with the late in-stent restenosis.
  • nitric oxide the active substance of nitro- glycerine
  • a catalyst is a substance that has the ability to change the property of other substances.
  • a catalyst is an enzyme that cleaves a protein into one active part and one non-active part.
  • An example from the physiology is the production of insulin, which is a product of pro-insulin. Through an enzymatic process the pro-insulin is cleaved into the active insulin and an inactive C-peptide before it is released into the blood circulation.
  • pro-insulin Through an enzymatic process the pro-insulin is cleaved into the active insulin and an inactive C-peptide before it is released into the blood circulation.
  • different surfaces covered with platinum can be used as a catalyst and speed up certain chemical processes.
  • a catalyst is a substance that facilitates a certain biochemical or chemical reaction without being consumed by the reaction itself.
  • the aim of the present invention is to give the stent or the surface of the stent the property of increasing the concentration of substances that inhibit unwanted cell growth in the stent area and prevent in-stent restenosis.
  • the actual growth inhibiting substances can be radioactive, become radioactive or be non-radioactive from different sources.
  • the examples below rare given to illustrate the pharmacological principles through known and are not necessarily related to the coating of the stent.
  • Substances from the nitro-glycerine family are used to treat angina. These pharmaceuticals contain all NO3- groups either as mono-, di or trinitrates. Enzymatically with help of a reductase (mitochondrial aldehyde dehydrogenase) these groups are cleaved off and form NO-groups, which dilate the vessels, but also exert an inhibitory effect on cell growth after implantation of a stent in a vessel. 2.
  • a chemical substance enters the body as an inactive pro-drug and is changed into an active drug because of the property of the stent.
  • proguanil against malaria which enters the body in an inactive form and is chemically changed to the active substance, cycloguanil via enzymatic influence.
  • the stent is magnetic and the substance is attached to a carrier which is attracted by the magnetism thereby concentrating the substance around the stent area.
  • Example is an attachment of the substance to a protein or peptide that binds to a receptor on the surface of the stent and concentrates the substance on the stent and in the area around the stent. 6. Blockage of the enzymatic process to remove one or more cell growth inhibiting substance that enters the body increases the concentration of the substances in the area around the stent.
  • Blockage of the enzymatic process to remove one or more naturally existing cell growth inhibiting substances increases the concentration of the substances in the area around the stent.
  • the stent is coated with a substance that blocks a catalytic enzyme system.
  • a substance that blocks a catalytic enzyme system As an example is mentioned the angiotensin II converting enzyme inhibitors that blocks the formation of angiotensin II from angiotensin I, a principle that is used to treat hypertension.
  • the coating of the stent induces formation of a substance that leads to formation of a cell growth inhibiting substance.
  • Nicardipin has also been shown to block the removal of the NO.

Landscapes

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

Abstract

L'invention concerne un extenseur destiné à être implanté dans un vaisseau sanguin. Cet extenseur ou la surface de ce dernier a la capacité de modifier au moins une substance parmi des substances sanguines existant naturellement ou des substances ajoutées qui entrent en contact avec l'extenseur ou la surface de ce dernier, et fait en sorte qu'après cette modification, ces substances fassent preuve d'une activité biologique avec un effet d'inhibition de la croissance sur le tissu adjacent, par exemple à travers une réaction catalytique, sans modifier la partie active de l'extenseur ou de la surface de ce dernier ou tout au plus en diminuant la partie active de l'extenseur uniquement dans une moindre mesure.
PCT/SE2002/001388 2001-07-20 2002-07-16 Changements de propritetes d'un extenseur pour prevenir la restenose WO2003008004A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0102578A SE0102578L (sv) 2001-07-20 2001-07-20 Förändring av en stents egenskaper för att förhindra restenos
SE0102578-2 2001-07-20

Publications (1)

Publication Number Publication Date
WO2003008004A1 true WO2003008004A1 (fr) 2003-01-30

Family

ID=20284909

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2002/001388 WO2003008004A1 (fr) 2001-07-20 2002-07-16 Changements de propritetes d'un extenseur pour prevenir la restenose

Country Status (2)

Country Link
SE (1) SE0102578L (fr)
WO (1) WO2003008004A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005037317A3 (fr) * 2003-10-17 2006-01-19 Cornell Res Foundation Inc Renine d'origine mastocytaire
CN103272280A (zh) * 2013-05-24 2013-09-04 南京大学医学院附属鼓楼医院 一种对脱细胞血管支架或人造血管改性的方法
US10517839B2 (en) 2008-06-09 2019-12-31 Cornell University Mast cell inhibition in diseases of the retina and vitreous

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998017331A1 (fr) * 1995-06-07 1998-04-30 Cook Incorporated Dispositif medical implantable et contenant de l'argent
WO1998020027A2 (fr) * 1996-11-01 1998-05-14 Eurogene Limited Utilisation therapeutique d'un facteur de croissance et systeme d'administration, en particulier pour le traitement de l'hyperplasie endoveineuse
US20020007213A1 (en) * 2000-05-19 2002-01-17 Robert Falotico Drug/drug delivery systems for the prevention and treatment of vascular disease

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998017331A1 (fr) * 1995-06-07 1998-04-30 Cook Incorporated Dispositif medical implantable et contenant de l'argent
WO1998020027A2 (fr) * 1996-11-01 1998-05-14 Eurogene Limited Utilisation therapeutique d'un facteur de croissance et systeme d'administration, en particulier pour le traitement de l'hyperplasie endoveineuse
US20020007213A1 (en) * 2000-05-19 2002-01-17 Robert Falotico Drug/drug delivery systems for the prevention and treatment of vascular disease

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005037317A3 (fr) * 2003-10-17 2006-01-19 Cornell Res Foundation Inc Renine d'origine mastocytaire
US10517839B2 (en) 2008-06-09 2019-12-31 Cornell University Mast cell inhibition in diseases of the retina and vitreous
CN103272280A (zh) * 2013-05-24 2013-09-04 南京大学医学院附属鼓楼医院 一种对脱细胞血管支架或人造血管改性的方法

Also Published As

Publication number Publication date
SE0102578D0 (sv) 2001-07-20
SE0102578L (sv) 2003-01-21

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