RU2005111767A - Способ и устройство для взятия проб и анализа образцов интерстициальной жидкости и цельной крови - Google Patents
Способ и устройство для взятия проб и анализа образцов интерстициальной жидкости и цельной крови Download PDFInfo
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
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- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
- A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
- A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
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Claims (25)
1. Устройство для взятия проб жидкости, содержащее корпус, имеющий зонд для проникновения через дермальный слой с проникающим и сообщающим концами, и камеру для анализа, имеющую проксимальный конец и дистальный конец, причем объем камеры для анализа обеспечивает сообщение проникающего зонда через жидкость с камерой для анализа так, что жидкость может течь из проникающего зонда по направлению к камере для анализа, камера для анализа имеет, по меньшей мере, одну гибкую стенку, так что при сдавливании гибкой стенки объем камеры для анализа уменьшается, дополнительно содержит предварительную камеру, имеющую первый и второй конец, размещенную между проникающим зондом и камерой для анализа так, что первый конец предварительной камеры примыкает к сообщающему концу проникающего зонда, а второй конец предварительной камеры примыкает к проксимальному концу камеры для анализа, объем предварительной камеры больше, чем объем камеры для анализа, предварительная камера имеет, по меньшей мере, одну гибкую стенку, так что при сдавливании гибкой стенки объем предварительной камеры уменьшается, предварительная камера содержит клапан на первом конце для герметизации предварительной камеры от проникающего зонда.
2. Устройство по п.1, отличающееся тем, что предварительная камера способна оказывать воздействие первой капиллярной силы, а камера для анализа способна оказывать воздействие второй капиллярной силы, причем первая и вторая капиллярные силы отличаются по величине, вторая капиллярная сила больше, чем первая капиллярная сила.
3. Устройство по п.1, отличающееся тем, что внутренняя поверхность предварительной камеры содержит, по меньшей мере, первую и вторую стенки, расположенные с зазором, имеющим первую величину для ограничения высоты предварительной камеры, при этом внутренняя поверхность камеры для анализа содержит, по меньшей мере, первую и вторую стенки камеры для анализа, расположенные с зазором, имеющим вторую величину для ограничения высоты камеры для анализа, причем высота камеры для анализа меньше, чем высота предварительной камеры, а различие капиллярных сил происходит, по меньшей мере частично, от разницы между высотой предварительной камеры и высотой камеры для анализа, по меньшей мере, одна из указанных камер содержит вещество, способное увеличить или уменьшить капиллярную силу, оказываемую камерой, указанное вещество выбрано из группы, состоящей из полимера, смолы, порошка, сетки, волокнистого материала, кристаллического материала, пористого материала или их комбинации, полиэтиленгликоля, полнивинилпирролидона, поверхностно-активного вещества, гидрофильного блока сополимера и поливинилацетата.
4. Устройство по п.1, отличающееся тем, что предварительная камера содержит первую стенку и вторую стенку, и камера для анализа содержит первую стенку и вторую стенку, при этом расстояние между стенками предварительной камеры больше, чем расстояние между стенками камеры для анализа.
5. Устройство по п.1, отличающееся тем, что дополнительно содержит сжимаемую надувную камеру, сообщающуюся с камерой для анализа, причем сжимаемая надувная камера способна оказывать положительное или отрицательное давление на камеру для анализа, сжимаемая надувная камера открывается в дистальный конец камеры для анализа.
6. Устройство по п.1, отличающееся тем, что проникающий зонд выбран из группы, состоящей из иглы, ланцета, трубки, канала или твердого выступа, проникающий зонд содержит материал, выбранный из группы, состоящей из угольного волокна, борного волокна, пластика, металла, стекла, керамики, композитного материала, их смесей и их комбинаций, проникающий зонд содержит два листка материала, имеющие выступ на каждом листке, причем листки размещены с зазором так, что жидкость может всасываться между листками капиллярным действием.
7. Устройство по п.6, отличающееся тем, что два листка материала проникающего зонда входят в устройство с образованием предварительной камеры, прилегающей к камере для анализа и сообщающейся с ней через жидкость.
8. Устройство по п.1, отличающееся тем, что устройство имеет проксимальный край с выемкой, а проникающий зонд размещен внутри выемки, выемка конфигурирована для совмещения с формой выбранной поверхности кожи.
9. Устройство по п.1, отличающееся тем, что дополнительно содержит выбрасываемый пускатель для приложения усилия, достаточного для проникновения проникающего зонда через дермальный слой, пускатель размещен снаружи от корпуса и после высвобождения проталкивает корпус в направлении к дермальному слою, пускатель является составной частью корпуса, после высвобождения пускатель проталкивает корпус в направлении к дермальному слою.
10. Устройство по п.1, отличающееся тем, что камера для анализа содержит гальванический элемент, имеющий рабочий электрод и опорный электрод.
11. Устройство по п.1, отличающееся тем, что содержит коммутатор для соединения с измерительным устройством, коммутатор предназначен для подачи напряжения или тока.
12. Способ определения наличия или отсутствия анализируемого вещества в образце жидкости, заключающийся в том, что используют устройство для взятия проб жидкости, содержащее зонд для проникновения через дермальный слой с проникающим концом и сообщающим концом и камеру для анализа, имеющую проксимальный конец и дистальный конец, причем объем камеры для анализа обеспечивает сообщение проникающего зонда через жидкость с камерой для анализа так, что жидкость может течь из проникающего зонда по направлению к камере для анализа, проникают через дермальный слой проникающим зондом, заполняют камеру для анализа образцом жидкости, которая перетекает от проникающего зонда в направлении камеры для анализа, определяют наличие или отсутствие анализируемого вещества внутри камеры для анализа, образец выбирают из группы, состоящей из интерстициальной жидкости и цельной крови.
13. Способ по п.12, отличающийся тем, что шаг определения наличия/отсутствия анализируемого вещества включает качественное или количественное измерение характеристики образца, характеристика образца включает продукт реакции анализируемого вещества, продукт реакции выбран из группы, состоящей из цветового индикатора, электрического тока, электрического потенциала, кислоты, основания, осадка и газа.
14. Способ по п.12, отличающийся тем, что анализируемое вещество выбрано из группы, состоящей из иона, элемента, сахара, спирта, гормона, белка, фермента, кофактора, последовательности нуклеиновых кислот, липида, фармацевтического средства и наркотика, иона калия, этанола, холестерина и лактата.
15. Способ по п.12, отличающийся тем, что поток образца по направлению к камере для анализа создают движущей силой, причем движущая сила включает силу, выбранную из группы, состоящей из капиллярной силы и перепада давления.
16. Способ по п.12, отличающийся тем, что используют устройство для взятия проб жидкости, которое дополнительно содержит предварительную камеру, имеющую первый конец и второй конец, размещенную между проникающим зондом и камерой для анализа так, что первый конец предварительной камеры примыкает к сообщающему концу проникающего зонда, а второй конец предварительной камеры примыкает к проксимальному концу камеры для анализа, предварительная камера способна оказывать воздействие первой капиллярной силы, а камера для анализа способна оказывать воздействие второй капиллярной силы, причем первая и вторая капиллярные силы отличаются по величине, вторая капиллярная сила больше, чем первая капиллярная сила.
17. Способ по п.12, отличающийся тем, что внутренняя поверхность предварительной камеры содержит, по меньшей мере, первую и вторую стенки, размещенные с зазором, имеющим первую величину, для ограничения высоты предварительной камеры, при этом внутренняя поверхность камеры для анализа содержит, по меньшей мере, первую и вторую стенки, размещенные с зазором, имеющим вторую величину, для ограничения высоты камеры для анализа, причем высота камеры для анализа меньше, чем высота предварительной камеры, а различие капиллярных сил происходит, по меньшей мере, частично от разницы между высотой предварительной камеры и высотой камеры для анализа.
18. Способ по п.16, отличающийся тем, что, по меньшей мере, одна из указанных камер содержит вещество, способное увеличить или уменьшить капиллярную силу, оказываемую камерой, вещество выбрано из группы, состоящей из полимера, смолы, порошка, сетки, волокнистого материала, кристаллического материала, пористого материала или их комбинации, из полиэтиленгликоля, полнивинилпирролидона, поверхностно-активного вещества, гидрофильного блок-сополимера и полиакриловой кислоты.
19. Способ по п.15, отличающийся тем, что перепад давления включает положительное давление, подаваемое по направлению к камере для анализа или отрицательное давление, подаваемое от камеры для анализа.
20. Способ по п.12, отличающийся тем, что предварительная камера дополнительно содержит, по меньшей мере, одну гибкую стенку, при сдавливании которой объем предварительной камеры уменьшается, клапан на первом конце, предназначенный для герметизации предварительной камеры от проникающего зонда, на шаге заполнения камеры для анализа образцом осуществляют закрытие клапана и сжатие предварительной камеры.
21. Способ по п.12, отличающийся тем, что камера для анализа имеет, по меньшей мере, одну гибкую стенку, при сдавливании которой объем камеры для анализа уменьшается.
22. Способ по п.12, отличающийся тем, что дополнительно воздействуют сжимающей силой на гибкую стенку камеры для анализа для уменьшения ее объема, прекращают сжатие для образования частичного вакуума в камере для анализа.
23. Способ по п.12, отличающийся тем, что до шага проникновения через дермальный слой воздействуют силой, после чего сжатие прекращают.
24. Способ по п.12, отличающийся тем, что устройство для взятия проб жидкости дополнительно содержит сжимаемую надувную камеру, сообщающуюся с камерой для анализа, причем сжимаемая надувная камера способна оказывать положительное или отрицательное давление на камеру для анализа, дополнительно воздействуют сжимающей силой на сжимаемую надувную камеру для уменьшения объема сжимаемой надувной камеры и прекращают действие силы сжатия для образования частичного вакуума в сжимаемой надувной камере и камере для анализа.
25. Способ по п.12, отличающийся тем, что до шага проникновения через дермальный слой воздействуют силой, после чего сжатие прекращают.
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2000
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