RU2013128336A - Композиция i-ii, содержащие ее изделия и ее применения - Google Patents

Композиция i-ii, содержащие ее изделия и ее применения Download PDF

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RU2013128336A
RU2013128336A RU2013128336/05A RU2013128336A RU2013128336A RU 2013128336 A RU2013128336 A RU 2013128336A RU 2013128336/05 A RU2013128336/05 A RU 2013128336/05A RU 2013128336 A RU2013128336 A RU 2013128336A RU 2013128336 A RU2013128336 A RU 2013128336A
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composition
composition according
applications
wound
polymer
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Маркус Дэмиан ФИЛИПС
Дельфина БЛАН
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СМИТ ЭНД НЕФЬЮ ПиЭлСи
Блустар Силиконс Франс Сас
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    • 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91Suction aspects of the dressing
    • A61M1/915Constructional details of the pressure distribution manifold
    • A61F13/05
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/58Adhesives
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/58Adhesives
    • A61L15/585Mixtures of macromolecular compounds
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001Use of materials characterised by their function or physical properties
    • A61L24/0036Porous materials, e.g. foams or sponges
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0047Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L24/0073Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/0085Porous materials, e.g. foams or sponges
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0095Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L83/00Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
    • C08L83/04Polysiloxanes
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G77/00Macromolecular compounds obtained by reactions forming a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon in the main chain of the macromolecule
    • C08G77/04Polysiloxanes
    • C08G77/12Polysiloxanes containing silicon bound to hydrogen
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G77/00Macromolecular compounds obtained by reactions forming a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon in the main chain of the macromolecule
    • C08G77/04Polysiloxanes
    • C08G77/20Polysiloxanes containing silicon bound to unsaturated aliphatic groups

Abstract

1. Вулканизируемая композиция, пропорционально распределенная между по меньшей мере одной частью А и по меньшей мере одной частью В композиции, где по меньшей мере одна часть А включает:(i) один или более чем один алкенил-содержащий полимер, содержащий по меньшей мере одну или по меньшей мере две алкенильные группы или группировки на молекулу,по меньшей мере одна часть В включает:(ii) один или более чем один SiH-содержащий полимер, включающий по меньшей мере одно или по меньшей мере два звена SiH или группировок на молекулу;и композиция дополнительно включает:(iii) катализатор для вулканизации путем присоединения алкенил-содержащего полимера (i) к SiH-содержащему полимеру (ii),и необязательно (iv) газообразователь, выбранный из любого агента, выделяющего газ, как компонент реакции или во время реакции вулканизации;где полимер (ii) отсутствует в части А, и полимер (i) отсутствует в части В композиции или часть В включает следовое количество полимера (i), выраженное как молярное соотношение (Si-H звено или группировка)/(алкенильное звено или группировка), большее или равное 2000.2. Композиция по п.1, где по меньшей мере одна часть А композиции включает катализатор.3. Композиция по п.1, являющаяся окончательно стерильной, отличающаяся уровнем гарантии стерильности (SAL, sterility assurance level) менее или равным 10, или, другими словами, теоретическая возможность присутствия жизнеспособного микроорганизма является равной или меньшей 1×10.4. Композиция по п.1, где часть А или каждая из частей А композиции и/или часть В или каждая из частей В композиции является стерилизованной облучением, предпочтительно выбранным из облучения гамма-лучами, рентгеновскими

Claims (19)

1. Вулканизируемая композиция, пропорционально распределенная между по меньшей мере одной частью А и по меньшей мере одной частью В композиции, где по меньшей мере одна часть А включает:
(i) один или более чем один алкенил-содержащий полимер, содержащий по меньшей мере одну или по меньшей мере две алкенильные группы или группировки на молекулу,
по меньшей мере одна часть В включает:
(ii) один или более чем один SiH-содержащий полимер, включающий по меньшей мере одно или по меньшей мере два звена SiH или группировок на молекулу;
и композиция дополнительно включает:
(iii) катализатор для вулканизации путем присоединения алкенил-содержащего полимера (i) к SiH-содержащему полимеру (ii),
и необязательно (iv) газообразователь, выбранный из любого агента, выделяющего газ, как компонент реакции или во время реакции вулканизации;
где полимер (ii) отсутствует в части А, и полимер (i) отсутствует в части В композиции или часть В включает следовое количество полимера (i), выраженное как молярное соотношение (Si-H звено или группировка)/(алкенильное звено или группировка), большее или равное 2000.
2. Композиция по п.1, где по меньшей мере одна часть А композиции включает катализатор.
3. Композиция по п.1, являющаяся окончательно стерильной, отличающаяся уровнем гарантии стерильности (SAL, sterility assurance level) менее или равным 10-6, или, другими словами, теоретическая возможность присутствия жизнеспособного микроорганизма является равной или меньшей 1×10-6.
4. Композиция по п.1, где часть А или каждая из частей А композиции и/или часть В или каждая из частей В композиции является стерилизованной облучением, предпочтительно выбранным из облучения гамма-лучами, рентгеновскими лучами и электронными лучами, а также их комбинациями.
5. Вулканизируемая композиция по п.1, где полимеры (i) и (ii) выбраны из: силиконов, включая силоксаны и модифицированные силоксаны, полиуретанов (PU), включая сложные полиэфируретаны и простые полиэфируретаны, эластомерных сополимеров простых полиэфиров и сложных полиэфиров, полигликолевой кислоты, полиацетатов, таких как этилвинилацетат, полиакрилата, поликислотных производных полисахаридов, таких как карбоксиалкилцеллюлоза, карбоксиалкилхитозан и их сополимеры, а также их гибридов, включающих сополимеры, сплетенные системы и их смеси.
6. Вулканизируемая композиция по п.1, где применяют дополнительную реакцию вулканизации между звеньями органогидросилоксана и звеньями органоалкенилсилоксана, необязательно включенными в полимеры, сополимеры, сплетенные полимеры и смешанные полимеры, как определено в п.5, где полимеры (i) и (ii) представляют собой органосилоксаны, предпочтительно полиорганосилоксаны.
7. Вулканизируемая композиция по п.1, где часть A или часть B композиции включает регулятор вязкости или разбавитель в количестве, увеличивающем или уменьшающем ее объем и/или вязкость, например, силиконовое масло, имеющее любую нужную вязкость для сгущающего или разбавляющего эффекта.
8. Композиция по п.1, где отношение вязкости части A : части B композиции находится в диапазоне, составляющем от 6:1 до 1:8, предпочтительно 5:1-1:5, более предпочтительно по существу 1:1, и для которой стерилизация полимера может вызвать некоторое увеличение вязкости, и, следовательно, отношение вязкости предпочтительно имеет такие значения после стерилизации частей композиции.
9. Вулканизируемая композиция по п.1 для медицинского или немедицинского, стоматологического или нестоматологического применения в качестве красителей; консервантов; гелей; пен; аэрозолей; фармацевтических препаратов; клеев; инкапсулянтов; средств ухода за волосами/кожей; косметического применения; стоматологического применения; разделительных слоев; покрытий; клеев и герметиков; лечения ран, включая повязку на рану; ухода за кожей, включая восстановление рубцов; ухода за полостью рта; инкапсуляции медицинских устройств, таких как электронные устройства для биомедицинских применений; изготовления форм; ортопедического применения; систем доставки лекарственных средств, включающих противомикробные системы; гемостатических и фармацевтических систем; питания, включая изготовление пищевых продуктов; авиационно-космического применения, морских и подводных применений; экологически чувствительных применений; ограничения или изоляции организмов или их обитателей, либо ограничения или изоляции среды или атмосферы, например, организмов, обладающих низким иммунитетом; стерильных, чистых и асептических применений; проращивания или размножения биомассы, такой как растения или организмы; включая изготовление и ремонт оборудования, аппаратов или компонентов для любого из вышеописанных применений и, в частности, воздушно-космического, подводного, стерильного, чистого или асептического применения, проращивания или размножения, включая применения в качестве пен, аэрозолей, клеев, разделительных слоев; для покрытий; клеев и герметиков, для лечения ран с применением терапии ран отрицательным давлением (NPWT), в частности в стерильном поле или окружении, включая применение в качестве заполнителя раны или материала для тампонирования ран, либо пенистой повязки, клея или герметика для закрытия полости раны, и применение в качестве заполнителя раны, клея или герметика в терапии ран отрицательным давлением, где по меньшей мере одна часть A и по меньшей мере одна часть B композиции приспособлены к тому, чтобы их можно было распределять контактным путем, способствующим их тесному контакту и вулканизации и образованию пористой пены, способной передавать отрицательное давление на поверхность раны, приклеивать хирургическую салфетку для терапии ран отрицательным давлением, либо которая является воздухонепроницаемой.
10. Композиция по п.1, распределяемая в область, где область имеет форму устройства или картриджей для него, где устройство включает смесительную насадку, имеющую средства для приема 2-х или большего числа картриджей, включающих части A и B композиции.
11. Способ получения композиции по любому из пп.1-10, включающий следующие стадии:
объединение полимеров (i) и (ii), катализатора (iii) и необязательного газообразователя (iv), как определено выше, с образованием по меньшей мере одной части A композиции и по меньшей мере одной части B композиции, как определено выше.
12. Способ стерилизации композиции по любому из пп.1-10, включающий облучение частей композиции, предпочтительно облучение гамма-лучами, рентгеновскими лучами или электронными лучами в стерилизующей дозе, или облучение по меньшей мере одной из части A и части B композиции и стерилизацию другой ее части(ей) альтернативными средствами.
13. Способ получения эластомера, включающий объединение по меньшей мере одной части A и по меньшей мере одной части B композиции по любому из пп.1-10 с их вулканизацией или сшиванием.
14. Эластомер, включающий вулканизированную или сшитую композицию по любому из пп.1-10.
15. Медицинское или немедицинское применение композиции или эластомера по любому из пп.1-10 или 14, в частности, выбранное из применений в качестве красителей; консервантов; гелей; пен; аэрозолей; фармацевтических препаратов; клеев; инкапсулянтов; средств ухода за волосами/кожей; косметического применения; стоматологического применения; разделительных слоев; покрытий; клеев и герметиков; лечения ран; ухода за кожей, включая восстановление рубцов; ухода за полостью рта; инкапсуляции медицинских устройств, таких как электронные устройства для биомедицинских применений; изготовления форм; ортопедического применения; систем доставки лекарственных средств, включающих проивомикробные системы; гемостатических и фармацевтических систем; питания, включая изготовление пищевых продуктов; авиационно-космического применения, морских и подводных применений; экологически чувствительных применений; ограничения или изоляции организмов или их обитателей, либо ограничения или изоляции среды или атмосферы, например, организмов, обладающих низким иммунитетом; стерильных, чистых и асептических применений; проращивания или размножения биомассы, такой как растения или организмы; включая изготовление и ремонт оборудования, аппаратов или компонентов для любого из вышеописанных применений и, в частности, воздушно-космического, подводного, стерильного, чистого или асептического применения, проращивания или размножения.
16. Устройство для распределения композиции, содержащее композицию по любому из пп.1-10.
17. Устройство по п.16, где устройство включает смесительную насадку и средства для приема 2-х или большего числа картриджей, включающих части A и B композиции, или включает двухцилиндровый шприц, подходящий для загрузки 40 г полимеров и оснащенный смесительной насадкой.
18. Композиция по п.1 для применения в способе обработки области раны, включающем:
распределение вспениваемой композиции по п.1 по меньшей мере на участок области раны, где вспениваемая композиция образует пористый пенистый материал, способный к передаче отрицательного давления;
распределение композиции по п.1 по меньшей мере вокруг участка области раны, где композиция включает первую часть и вторую часть, которые при объединении образуют материал, способный к образованию герметика, по существу непроницаемого для жидкости; и
покрывание области раны хирургической салфеткой, по существу непроницаемой для жидкости, где хирургическая салфетка покрывает по меньшей мере часть распределенной композиции; или
наложение повязки на область раны;
высвобождение первой части композиции по п.1 из основы по меньшей мере около или вокруг участка области раны и выдерживание указанной части,
выдерживание второй части указанной композиции, нанесенной на хирургическую салфетку, непроницаемую для жидкости;
покрывание области раны хирургической салфеткой, в результате чего выдержанные первая и вторая части вступают в контакт и приклеивают хирургическую салфетку около или вокруг области раны;
причем способ дополнительно включает
образование герметичного непроницаемого для жидкости покрытия на области раны; и
приложение отрицательного давления к области раны, используя источник отрицательного давления, соединенный с областью раны.
19. Набор для терапии ран отрицательным давлением (NPWT), включающий повязку на рану, непроницаемую для жидкости, распределяемую или высвобождаемую вулканизируемую или вулканизированную вспениваемую композицию, вулканизируемую композицию клея или герметика или эластомера по любому из пп.1-10, 14 и 18 и средства присоединения вакуумного насоса для подачи отрицательного давления на повязку.
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US10537657B2 (en) 2020-01-21
RU2597393C2 (ru) 2016-09-10
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CN107033596A (zh) 2017-08-11
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MX337627B (es) 2016-03-10
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