RU2011120269A - Массив полых микроигл и способ использования - Google Patents

Массив полых микроигл и способ использования Download PDF

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RU2011120269A
RU2011120269A RU2011120269/14A RU2011120269A RU2011120269A RU 2011120269 A RU2011120269 A RU 2011120269A RU 2011120269/14 A RU2011120269/14 A RU 2011120269/14A RU 2011120269 A RU2011120269 A RU 2011120269A RU 2011120269 A RU2011120269 A RU 2011120269A
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microneedles
liquid
array
microns
hollow
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Скотт А. БЕРТОН
Франклин Л. ФРЕДЕРИКСОН
Кристен Дж. ХАНСЕН
Райан Патрик СИММЕРС
Перси Т. ФЕНН
Крэйг С. МОУКЛИ
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Зм Инновейтив Пропертиз Компани
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A61B5/150396—Specific tip design, e.g. for improved penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicinal Preparation (AREA)

Abstract

1. Способ быстрого и в больших объемах интрадермального введения жидкости при минимальной боли, содержащий этапы, на которых:накладывают массив, содержащий от 10 до 30 полых микроигл длиной более 100 мкм, на кожу пациента с глубиной их проникновения менее 1 мм, причем среднее расстояние между соседними микроиглами в массиве составляет в среднем не менее 1,5 мм;вводят через полые микроиглы более чем 200 мкл жидкости со скоростью, превышающей 20 мкл/мин.2. Способ по п.1, отличающийся тем, что массив содержит от 13 до 20 микроигл.3. Способ по п.1 или 2, отличающийся тем, что полые микроиглы характеризуются средним значением площади поперечного сечения канала от 20 до 50 мкм.4. Способ по п.1 или 2, отличающийся тем, что длина микроигл составляет от 500 до 750 мкм.5. Способ по п.1 или 2, отличающийся тем, что плотность микроигл в массиве составляет от 30 до 50 микроигл/см.6. Способ по п.1 или 2, отличающийся тем, что через микроиглы вводят по меньшей мере 750 мкл жидкости.7. Способ по п.1 или 2, отличающийся тем, что жидкость вводят через полые микроиглы со скоростью по меньшей мере 400 мкл/мин.8. Способ по п.1 или 2, отличающийся тем, что противодавление при введении жидкости составляет не более 25 фунтов/дюйм.9. Способ по п.8, отличающийся тем, что противодавление при введении жидкости поддерживают на уровне 20 фунтов/дюйм.10. Способ по п.1 или 2, отличающийся тем, что каждая из микроигл имеет выходное отверстие, расположенное на ее боковой стенке.11. Способ по п.1 или 2, отличающийся тем, что микроиглы заходят в дерму на глубину от 100 мкм до 400 мкм.12. Способ по п.1 или 2, отличающийся тем, что микроиглы расположены в среднем на расстоянии по меньшей мере 2 мм друг от друга.

Claims (12)

1. Способ быстрого и в больших объемах интрадермального введения жидкости при минимальной боли, содержащий этапы, на которых:
накладывают массив, содержащий от 10 до 30 полых микроигл длиной более 100 мкм, на кожу пациента с глубиной их проникновения менее 1 мм, причем среднее расстояние между соседними микроиглами в массиве составляет в среднем не менее 1,5 мм;
вводят через полые микроиглы более чем 200 мкл жидкости со скоростью, превышающей 20 мкл/мин.
2. Способ по п.1, отличающийся тем, что массив содержит от 13 до 20 микроигл.
3. Способ по п.1 или 2, отличающийся тем, что полые микроиглы характеризуются средним значением площади поперечного сечения канала от 20 до 50 мкм2.
4. Способ по п.1 или 2, отличающийся тем, что длина микроигл составляет от 500 до 750 мкм.
5. Способ по п.1 или 2, отличающийся тем, что плотность микроигл в массиве составляет от 30 до 50 микроигл/см2.
6. Способ по п.1 или 2, отличающийся тем, что через микроиглы вводят по меньшей мере 750 мкл жидкости.
7. Способ по п.1 или 2, отличающийся тем, что жидкость вводят через полые микроиглы со скоростью по меньшей мере 400 мкл/мин.
8. Способ по п.1 или 2, отличающийся тем, что противодавление при введении жидкости составляет не более 25 фунтов/дюйм2.
9. Способ по п.8, отличающийся тем, что противодавление при введении жидкости поддерживают на уровне 20 фунтов/дюйм2.
10. Способ по п.1 или 2, отличающийся тем, что каждая из микроигл имеет выходное отверстие, расположенное на ее боковой стенке.
11. Способ по п.1 или 2, отличающийся тем, что микроиглы заходят в дерму на глубину от 100 мкм до 400 мкм.
12. Способ по п.1 или 2, отличающийся тем, что микроиглы расположены в среднем на расстоянии по меньшей мере 2 мм друг от друга.
RU2011120269/14A 2008-11-18 2009-11-17 Массив полых микроигл и способ его использования RU2494769C2 (ru)

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US11584008P 2008-11-18 2008-11-18
US61/115,840 2008-11-18
PCT/US2009/064742 WO2010059605A2 (en) 2008-11-18 2009-11-17 Hollow microneedle array and method

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EP (2) EP3300765A1 (ru)
JP (2) JP2012509106A (ru)
KR (3) KR20110086854A (ru)
CN (2) CN105999538A (ru)
AU (1) AU2009316789B2 (ru)
BR (1) BRPI0916150B1 (ru)
CA (1) CA2742853C (ru)
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