RU2017116229A - Сухая композиция для использования при гемостазе и заживлении ран - Google Patents
Сухая композиция для использования при гемостазе и заживлении ран Download PDFInfo
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- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
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- 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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0028—Polypeptides; Proteins; Degradation products thereof
- A61L26/0038—Gelatin
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- 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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0066—Medicaments; Biocides
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- A—HUMAN NECESSITIES
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0085—Porous materials, e.g. foams or sponges
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/24—Crosslinking, e.g. vulcanising, of macromolecules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L2300/254—Enzymes, proenzymes
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2305/00—Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
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Claims (87)
1. Способ получения сухой композиции, включающий этапы:
a) смешивания биосовместимого полимера в порошкообразной форме, водной среды и щелочного соединения с получением пасты, и
b) сушки пасты,
причем щелочное соединение способно реагировать с кислотным соединением в водной среде с высвобождением газа.
2. Способ получения сухой композиции, включающий этапы:
a) смешивания биосовместимого полимера в порошкообразной форме, водной среды и кислотного соединения с получением пасты, и
b) сушки пасты,
причем кислотное соединение способно реагировать с щелочным соединением в водной среде с высвобождением газа.
3. Способ по любому из предшествующих пунктов, в котором пасту, получаемую на этапе a), подвергают i) пониженному давлению, что вызывает расширение пасты, и ii) расширенную пасту замораживают, перед этапом b).
4. Способ по любому из предшествующих пунктов, в котором пасту с этапа a) дополнительно смешивают с одним или несколькими гидрофильными соединениями.
5. Способ по любому из предшествующих пунктов, в котором биосовместимый полимер состоит из частиц порошка, которые по существу нерастворимы в водной среде.
6. Способ по любому из предшествующих пунктов, в котором биосовместимый полимер является поперечносшитым.
7. Способ по любому из предшествующих пунктов, в котором биосовместимый полимер содержит желатин или состоит из желатина.
8. Способ по п. 7, в котором желатин получают из микронизированной желатиновой губки, которая была поперечно сшита посредством обработки сухим теплом.
9. Способ по любому из предшествующих пунктов, в котором щелочное соединение и кислотное соединение являются физиологически приемлемыми соединениями.
10. Способ по любому из предшествующих пунктов, в котором газ представляет собой CO2.
11. Способ по любому из предшествующих пунктов, в котором щелочное соединение представляет собой углекислотную соль, такую как соль угольной кислоты, выбранная из группы, состоящей из бикарбоната натрия (NaHCO3), карбоната натрия (Na2CO3), бикарбоната калия (KHCO3), карбоната калия (K2CO3), бикарбоната кальция (Ca(HCO3)2), карбоната кальция (CaCO3), карбоната магния (MgCO3), бикарбоната магния (Mg(HCO3)2), бикарбоната аммония (NH4HCO3), карбоната аммония ((NH4)2CO3), бикарбоната гадолиния (Gd(HCO3)3, карбоната гадолиния (Gd2(CO3)3), бикарбоната лития (LiHCO3), карбоната лития (LiCO3), бикарбоната рубидия (RbHCO3), карбоната рубидия (Rb2CO3), карбоната цинка (ZnCO3), бикарбоната цинка (Zn(HCO3)2, карбоната железа (II) (FeCO3), бикарбоната железа (II) (Fe(HCO3)2), карбоната серебра (Ag2CO3), бикарбоната серебра (AgHCO3), карбоната золота (III) Au2(CO3)3, карбоната золота (I) (Au2CO3) и их смесей.
12. Способ по п. 11, в котором углекислотная соль представляет собой бикарбонат натрия (NaHCO3).
13. Способ по любому из предшествующих пунктов, в котором кислотное соединение выбирают из группы, состоящей из уксусной кислоты, лимонной кислоты, щавелевой кислоты и винной кислоты.
14. Способ по любому из предшествующих пунктов, в котором сухая композиция содержит от приблизительно 0,1% до приблизительно 10% щелочного соединения или кислотного соединения, например от приблизительно 0,5% до приблизительно 8% щелочного соединения или кислотного соединения, в том числе от приблизительно 1% до приблизительно 6% щелочного соединения или кислотного соединения или от приблизительно 1% до приблизительно 5% щелочного соединения или кислотного соединения.
15. Способ по любому из пп. 4-14, в котором сухая композиция содержит от приблизительно 10% до приблизительно 60% одного или нескольких гидрофильных соединений, например от приблизительно 15% до приблизительно 50% одного или нескольких гидрофильных соединений, в том числе от приблизительно 20% до приблизительно 45% одного или нескольких гидрофильных соединений, например от приблизительно 25% до приблизительно 45% одного или нескольких гидрофильных соединений.
16. Способ по любому из пп. 4-15, в котором одно или несколько гидрофильных соединений представляют собой один или несколько полиолов.
17. Способ по п. 16, в котором один или несколько полиолов выбирают из сахарных спиртов, сахаров и/или их производных.
18. Способ по п. 17, в котором один или несколько полиолов представляют собой сахарный спирт.
19. Способ по п. 18, в котором сахарный спирт выбирают из группы, состоящей из гликоля, глицерина, эритрита, треита, арабита, ксилита, рибита, маннита, сорбита, дульцита, фуцита, идита, инозита, волемита, изомальта, мальтита, лактита, полиглицита и их смесей.
20. Способ по п. 19, в котором сахарный спирт представляет собой маннит.
21. Способ по любому из пп. 4-15, в котором одно или несколько гидрофильных соединений представляют собой полиэтиленгликоль (PEG).
22. Способ по любому из предшествующих пунктов, в котором сушка представляет собой сублимационную сушку.
23. Способ по любому из предшествующих пунктов, в котором сушка приводит к сухой композиции, содержащей менее чем приблизительно 5% воды, предпочтительно менее чем приблизительно 2% воды, в том числе менее чем приблизительно 1% воды.
24. Способ по любому из предшествующих пунктов, в котором сухая композиция дополнительно содержит одно или несколько биоактивных средств, способных стимулировать гемостаз, заживление ран, заживление костей, заживление тканей и/или заживление сухожилий.
25. Способ по п. 24, в котором биоактивное средство представляет собой тромбин.
26. Способ по любому из предшествующих пунктов, в котором сухая композиция дополнительно содержит улучшитель выдавливания, такой как альбумин, предпочтительно человеческий сывороточный альбумин.
27. Способ по любому из предшествующих пунктов, в котором пасту, получаемую на этапе a), переносят в контейнер, пригодный для сушки пасты.
28. Способ по п. 27, в котором контейнер представляет собой устройство для медицинской доставки, пригодное для восстановления сухой композиции и дозирования пасты.
29. Способ по любому из пп. 27-28, в котором контейнер представляет собой шприц.
30. Способ по любому из предшествующих пунктов, в котором сухая композиция имеет форму листа.
31. Способ по любому из предшествующих пунктов, дополнительно включающий этап добавления
i) кислотного соединения в сухой форме после этапа b), если сухая композиция содержит щелочное соединение, или
ii) щелочного соединения в сухой форме после этапа b), если сухая композиция содержит кислотное соединение,
с получением тем самым сухой композиции, содержащей щелочное соединение и кислотное соединение.
32. Способ восстановления сухой композиции, получаемой с помощью способа по любому из предшествующих пунктов, дополнительно включающий этап добавления водной среды к сухой композиции, причем водная среда содержит:
i) кислотное соединение, если сухая композиция содержит щелочное соединение,
ii) щелочное соединение, если сухая композиция содержит кислотное соединение, или
iii) не содержит ни кислотного, ни щелочного соединения, если сухая композиция содержит как щелочное, так и кислотное соединение в соответствии со способом по п. 31,
причем кислотное соединение и щелочное соединение реагируют с высвобождением газа в присутствии упомянутой водной среды.
33. Способ по п. 32, в котором сухая композиция восстанавливается до пасты при добавлении водной среды без механического смешивания.
34. Паста, получаемая с помощью способа по любому из пп. 32-33.
35. Сухая композиция, содержащая биосовместимый полимер и
i) щелочное соединение и/или
ii) кислотное соединение,
где щелочное соединение в i) способно реагировать с кислотным соединением в присутствии водной среды с высвобождением газа, и/или где кислотное соединение в ii) способно реагировать с щелочным соединением в присутствии водной среды с высвобождением газа.
36. Сухая композиция, получаемая с помощью способа по любому из пп. 1-31.
37. Сухая композиция по любому из пп. 35-36 для применения с целью ускорения гемостаза и/или заживления ран.
38. Контейнер, содержащий
a) отсек продукта, содержащий i) сухую композиция по любому из пп. 35-36 или ii) сухую композицию, полученную с помощью способа по любому из пп. 1-31, и
b) клапан.
39. Контейнер по п. 38, представляющий собой устройство для медицинской доставки, предпочтительно шприц, такой как одноразовый пластмассовый шприц.
40. Способ восстановления сухой композиции, включающий этапы:
a) подготовки контейнера по любому из пп. 38-39, причем упомянутый контейнер представляет собой первый контейнер,
b) подготовки второго контейнера, содержащего водную среду,
c) соединения первого контейнера и второго контейнера с помощью подходящего соединяющего средства и
d) открывания клапана.
41. Способ по п. 40, в котором водная среда содержит
i) кислотное соединение, если сухая композиция содержит щелочное соединение,
ii) щелочное соединение, если сухая композиция содержит кислотное соединение, или
iii) не содержит ни кислотного, ни щелочного соединения, если сухая композиция содержит как щелочное, так и кислотное соединение.
42. Гемостатический набор, содержащий:
a) первый контейнер, содержащий сухую композицию, полученную с помощью способа по любому из пп. 1-31 или контейнер по любому из пп. 38-39,
b) второй контейнер, содержащий водную среду, как определено в п. 41, и,
c) необязательно, наружную упаковку.
43. Паста, подходящая для использования при гемостазе, содержащая биосовместимый полимер, причем упомянутая паста имеет консистенцию, составляющую менее чем 5000 г×с.
44. Паста по п. 43, в которой упомянутый биосовместимый полимер находится в форме по существу нерастворимых в воде частиц.
45. Паста по любому из пп. 43-44, в которой упомянутый биосовместимый полимер является поперечно-сшитым.
46. Паста по любому из пп. 43-45, в которой упомянутый биосовместимый полимер содержит желатин или состоит из желатина.
47. Паста по любому из пп. 43-46, причем консистенция данной пасты составляет менее чем 4500 г×с, в том числе менее чем 4000 г×с, например менее чем 3500 г×с, в том числе менее чем 3000 г×с, например менее чем 2500 г×с, в том числе менее чем 2000 г×с.
48. Паста по любому из пп. 43-47, причем данная паста дополнительно содержит одно или несколько гидрофильных соединений, таких как сахарный спирт.
49. Паста по любому из пп. 43-48, причем данная паста дополнительно содержит маннит.
50. Паста по любому из пп. 43-49, причем упомянутая паста дополнительно содержит одно или несколько дополнительных соединений, и/или биоактивных средств и/или, улучшителей выдавливания.
51. Паста по любому из пп. 43-50, причем упомянутая паста содержит тромбин.
52. Паста по любому из пп. 43-51, причем упомянутая паста содержит
a) биосовместимый полимер в количестве от приблизительно 10% (вес./вес.) до приблизительно 40% (вес./вес.),
b) водную среду, такую как вода.
53. Паста по любому из пп. 43-52, причем упомянутая паста содержит гидрофильное соединение в количестве от приблизительно 1% (вес./вес.) до приблизительно 20% (вес./вес.).
54. Паста по любому из пп. 43-53, причем упомянутая паста содержит биоактивное средство, такое как тромбин.
55. Паста по любому из пп. 43-54, причем упомянутая паста содержит улучшитель выдавливания.
56. Паста по любому из пп. 43-55 для применения с целью ускорения гемостаза и/или заживления ран.
57. Шприц, содержащий пасту по любому из пп. 43-55.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA201470634 | 2014-10-13 | ||
DKPA201470634 | 2014-10-13 | ||
DKPA201570450 | 2015-07-07 | ||
DKPA201570450 | 2015-07-07 | ||
PCT/DK2015/050311 WO2016058612A1 (en) | 2014-10-13 | 2015-10-13 | Dry composition for use in haemostasis and wound healing |
Publications (3)
Publication Number | Publication Date |
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RU2017116229A true RU2017116229A (ru) | 2018-11-15 |
RU2017116229A3 RU2017116229A3 (ru) | 2019-04-17 |
RU2715235C2 RU2715235C2 (ru) | 2020-02-26 |
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Application Number | Title | Priority Date | Filing Date |
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RU2017116229A RU2715235C2 (ru) | 2014-10-13 | 2015-10-13 | Сухая композиция для использования при гемостазе и заживлении ран |
Country Status (9)
Country | Link |
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US (1) | US11046818B2 (ru) |
EP (1) | EP3206726B1 (ru) |
JP (1) | JP6726852B2 (ru) |
CN (1) | CN106999621B (ru) |
AU (1) | AU2015333206B2 (ru) |
BR (1) | BR112017007466B1 (ru) |
CA (1) | CA2960309A1 (ru) |
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- 2015-10-13 BR BR112017007466-4A patent/BR112017007466B1/pt active IP Right Grant
- 2015-10-13 US US15/513,780 patent/US11046818B2/en active Active
- 2015-10-13 RU RU2017116229A patent/RU2715235C2/ru active
- 2015-10-13 JP JP2017512312A patent/JP6726852B2/ja active Active
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US11046818B2 (en) | 2021-06-29 |
BR112017007466B1 (pt) | 2021-03-02 |
JP6726852B2 (ja) | 2020-07-22 |
CA2960309A1 (en) | 2016-04-21 |
RU2715235C2 (ru) | 2020-02-26 |
EP3206726B1 (en) | 2020-05-27 |
AU2015333206A1 (en) | 2017-04-20 |
CN106999621B (zh) | 2020-07-03 |
BR112017007466A2 (pt) | 2018-01-23 |
CN106999621A (zh) | 2017-08-01 |
EP3206726A1 (en) | 2017-08-23 |
WO2016058612A1 (en) | 2016-04-21 |
RU2017116229A3 (ru) | 2019-04-17 |
JP2017531462A (ja) | 2017-10-26 |
US20200140625A1 (en) | 2020-05-07 |
AU2015333206B2 (en) | 2019-07-11 |
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