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RU2014119897A - Имплантируемое устройство для доставки биоактивного агента - Google Patents

Имплантируемое устройство для доставки биоактивного агента Download PDF

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RU2014119897A
RU2014119897A RU2014119897/14A RU2014119897A RU2014119897A RU 2014119897 A RU2014119897 A RU 2014119897A RU 2014119897/14 A RU2014119897/14 A RU 2014119897/14A RU 2014119897 A RU2014119897 A RU 2014119897A RU 2014119897 A RU2014119897 A RU 2014119897A
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delivery device
nanostructures
implantable delivery
implantable
microstructures
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RU2014119897/14A
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English (en)
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Джереми ОЛЛЕРЕНШО
Эмили РЕЙХАРТ
Расселл Ф. РОСС
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Кимберли-Кларк Ворлдвайд, Инк.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0097Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips
    • 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
    • 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
    • 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
    • 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
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0081Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/12Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053Methods for producing microneedles

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Prostheses (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

1. Имплантируемое устройство для доставки биоактивного агента субъекту включающее:- множество наноструктур, изготовленных на поверхности имплантируемого устройства для доставки и расположенных согласно заданному паттерну;биологически активный агент, находящийся внутри или на поверхности данного имплантируемого устройства для доставки.2. Имплантируемое устройство для доставки по п. 1, отличающееся тем, что биологически активный агент представляет собой компонент композиции, причем эта композиция дополнительно содержит один или несколько фармацевтически приемлемых эксципиентов и/или матрицу с замедленным высвобождением.3. Имплантируемое устройство для доставки по п. 1 или 2, отличающееся тем, что паттерн также содержит микроструктуры, причем поперечный размер наноструктур меньше, чем у микроструктур.4. Имплантируемое устройство для доставки по п. 3, отличающееся тем, что микроструктуры имеют поперечный размер более чем примерно 500 нм, а наноструктуры имеют поперечный размер менее чем примерно 300 нм.5. Имплантируемое устройство для доставки по п. 3, содержащее также вторичные наноструктуры, имеющие размер поперечного сечения меньше, чем размер поперечного сечения микроструктур и больше, чем размер поперечного сечения первичных наноструктур.6. Имплантируемое устройство для доставки по п. 1, в котором, по крайней мере, часть наноструктур имеют одну или более следующих характеристик:а) расстояние между центрами составляет от примерно 50 нм до примерно 1 мкм,б) высота их составляет от примерно 10 нм до примерно 20 мкм,в) соотношение их сторон составляет от примерно 0,15 до примерно 30.7. Имплантируемое устройство для до�

Claims (14)

1. Имплантируемое устройство для доставки биоактивного агента субъекту включающее:
- множество наноструктур, изготовленных на поверхности имплантируемого устройства для доставки и расположенных согласно заданному паттерну;
биологически активный агент, находящийся внутри или на поверхности данного имплантируемого устройства для доставки.
2. Имплантируемое устройство для доставки по п. 1, отличающееся тем, что биологически активный агент представляет собой компонент композиции, причем эта композиция дополнительно содержит один или несколько фармацевтически приемлемых эксципиентов и/или матрицу с замедленным высвобождением.
3. Имплантируемое устройство для доставки по п. 1 или 2, отличающееся тем, что паттерн также содержит микроструктуры, причем поперечный размер наноструктур меньше, чем у микроструктур.
4. Имплантируемое устройство для доставки по п. 3, отличающееся тем, что микроструктуры имеют поперечный размер более чем примерно 500 нм, а наноструктуры имеют поперечный размер менее чем примерно 300 нм.
5. Имплантируемое устройство для доставки по п. 3, содержащее также вторичные наноструктуры, имеющие размер поперечного сечения меньше, чем размер поперечного сечения микроструктур и больше, чем размер поперечного сечения первичных наноструктур.
6. Имплантируемое устройство для доставки по п. 1, в котором, по крайней мере, часть наноструктур имеют одну или более следующих характеристик:
а) расстояние между центрами составляет от примерно 50 нм до примерно 1 мкм,
б) высота их составляет от примерно 10 нм до примерно 20 мкм,
в) соотношение их сторон составляет от примерно 0,15 до примерно 30.
7. Имплантируемое устройство для доставки по п. 1, отличающееся тем, что паттерн имеет фрактальную размерность больше чем примерно 1.
8. Имплантируемое устройство для доставки по п. 1, в котором поверхность микроиглы, содержащая множество наноструктур, имеет среднюю шероховатость поверхности от примерно 10 нм до примерно 200 нм и/или эффективный модуль сжатия от примерно 4 МПа до примерно 320 МПа.
9. Имплантируемое устройство для доставки по п. 1, содержащее резервуар, в котором содержится биоактивный агент.
10. Имплантируемое устройство для доставки по п. 1, включающее канавку на поверхности устройства, причем внутри этой канавки содержится биоактивный агент.
11. Способ формирования имплантируемого устройства для доставки по любому из пп. 1-10, включающий изготовление паттерна наноструктур на поверхности устройства.
12. Способ по п. 11, отличающийся тем, что изготовление паттерна наноструктур проводят при помощи методов, выбранных из группы, включающей фотолитографию, электронно-лучевую литографию, рентгеновскую литографию, методы самосборки, реактивное ионное травление, влажное травление, осаждение пленки, напыление, химическое осаждение из паровой фазы, эпитаксию, электропорацию, а также их комбинации.
13. Способ по п. 11, отличающийся тем, что изготовление паттерна наноструктур проводят на пленке, причем этот способ также включает нанесение пленки на поверхность имплантируемого устройства для доставки.
14. Способ по п. 11, дополнительно включающий помещение биологически активного агента внутрь или снаружи устройства, например в резервуар этого устройства или на поверхность устройства.
RU2014119897/14A 2011-10-27 2012-10-16 Имплантируемое устройство для доставки биоактивного агента RU2014119897A (ru)

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US201161552059P 2011-10-27 2011-10-27
US61/552,059 2011-10-27
PCT/IB2012/055622 WO2013061209A1 (en) 2011-10-27 2012-10-16 Implantable devices for delivery of bioactive agents

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US (2) US11110066B2 (ru)
EP (3) EP3542851B1 (ru)
JP (1) JP6535464B2 (ru)
KR (1) KR20140079429A (ru)
CN (1) CN103906549A (ru)
AU (1) AU2012328038B2 (ru)
BR (1) BR112014009712A2 (ru)
CA (1) CA2850931A1 (ru)
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ES (1) ES2908653T3 (ru)
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MX (1) MX2014004690A (ru)
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US11925712B2 (en) 2024-03-12
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CN103906549A (zh) 2014-07-02
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