BR112012000220A2 - Métodos e dispositivos médicos - Google Patents
Métodos e dispositivos médicos Download PDFInfo
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- BR112012000220A2 BR112012000220A2 BR112012000220-1A BR112012000220A BR112012000220A2 BR 112012000220 A2 BR112012000220 A2 BR 112012000220A2 BR 112012000220 A BR112012000220 A BR 112012000220A BR 112012000220 A2 BR112012000220 A2 BR 112012000220A2
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- GPEFCRXOFGOZFQ-LURJTMIESA-N C[C@@H](CC1CCC1)N Chemical compound C[C@@H](CC1CCC1)N GPEFCRXOFGOZFQ-LURJTMIESA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/0017—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system transmitting optical signals
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B5/14532—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 glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/48785—Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
- G01N33/48792—Data management, e.g. communication with processing unit
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q50/00—Systems or methods specially adapted for specific business sectors, e.g. utilities or tourism
- G06Q50/10—Services
- G06Q50/22—Social work
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/02—Operational features
- A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
- A61B2560/0238—Means for recording calibration data
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Abstract
métodos e dispositivos médicos. trata-se de métodos e dispositivos médicos para monitorar um analito em fluido sanguíneo. as modalidades incluem aquisição separada ou contínua de dados relacionados a analito de um sensor de analito in vivo transcutaneamente posicionado automaticamente ou me diante solicitação de um usuário.
Description
Relatório Descritivo da Patente de Invenção para "MÉTODOS E DISPOSITIVOS MÉDICOS",
PRIORIDADE O presente pedido reivindica o benefício ao Pedido Provisório U.S.No.61/238.581 depositado em 31 de agosto de 2009, Pedido Provisório U.S. No. 61/247.519 depositado em 30 de setembro de 2009, Pedido Provi- sório U.S. No. 61/247.514 depositado em 30 de setembro de 2009, Pedido Provisório U.S. No. 61/247.508 depositado em 30 de setembro de 2009, Pe- dido Provisório U.S. No. 61/256.925 depositado em 30 de outubro de 2009, Pedido Provisório U.S. No. 61/291.326 depositado em 30 de dezembro de 2009, e Pedido Provisório U.S. No. 61/299.924 depositado em 29 de janeiro de 2010, estando cada uma das descrições aqui incorporadas a título de referência para todos os propósitos.
INCORPORAÇÃO A TÍTULO DE REFERÊNCIA As patentes, pedidos e/ou publicações aqui descritos, incluindo as seguintes patentes, pedidos e/ou publicações se encontram aqui incorpo- rados a título de referência para todos os propósitos: Patentes U.S. Nos.
4.545.382; 4.711.245; 5.262.035; 5.262.305; 5.264.104; 5.320.715;
5.356.786; 5.509.410; 5.543.326; 5.593.852; 5.601.435; 5.628.890;
5.820.551; 5.822.715; 5.899.855; 5.918.603; 6.071.391; 6.103.033;
6.120.676; 6.121.009; 6.134.461; 6.143.164; 6.144.837; 6.161.095;
6.175.752; 6.270.455; 6.284.478; 6.299.757; 6.338.790; 6.377.894;
6.461.496; 6.503.381; 6.514.460; 6.514.718; 6.540.891; 6.560.471;
6.579.690; 6.591.125; 6.592.745; 6.600.997; 6.605.200; 6.605.201;
6.616.819; 6.618.934; 6.650.471; 6.654.625; 6.676.816; 6.730.200;
6.736.957; 6.746.582; 6.749.740; 6.764.581; 6.773.671; 6.881.551;
6.893.545; 6.932.892; 6.932.894; 6.942.518; 7.041.468; 7.167.818; e
7.299.082; Pedidos Publicados U.S. Nos. 2004/0186365; 2005/0182306; 2006/0025662; 2006/0091006; 2007/0056858; 2007/0068807; 2007/0095661; 2007/0108048; 2007/0199818; 2007/0227911; 2007/0233013; 2008/0066305; 2008/0081977; 2008/0102441; 2008/0148873; 2008/0161666; 2008/0267823; e 2009/0054748; Pedidos de Patente U.S. com Número de Série 11/461.725;
12/131.012; 12/393.921. 12/242.823; 12/363.712; 12/495.709; 12/698.124; 12/698.129; 12/714.439; 12/794.721; e 12/842.013. e Pedidos Provisórios U.S. Nos. 61/238.646; 61/246.825; 61/247.516; 61/249.535; 61/317.243; 61/345.562 e 61/361.374.
ANTECEDENTES A detecção e/ou monitoramento de níveis de glicose ou outros analitos, tal como lactato, oxigênio, A1C, ou similares, em determinados in- divíduos são vitalmente importantes para suas saúdes. Por exemplo, o moni- toramento de glicose é particularmente importante a indivíduos com diabe- tes. Os diabéticos geralmente monitoram os níveis de glicose de modo a determinar se seus níveis de glicose estão sendo mantidos dentro de uma faixa clinicamente segura, e também podem usar estas informações para determinar se e/ou quando insulina é necessária para reduzir os níveis de glicose em seus corpos ou quando for necessária glicose adicional para ele- varo nível de glicose em seus corpos.
Dados clínicos crescentes demonstram uma forte correlação en- tre a frequência de monitoramento de glicose e controle glicêmico. Apesar de tal correlação, muitos indivíduos diagnosticados com uma condição dia- bética não monitoram seus níveis de glicose tão frequentemente quanto de- veriam devido a uma combinação de fatores que incluem conveniência, dis- crição de teste, dor associada ao teste de glicose, e custos.
Desenvolveram-se dispositivos para o monitoramento automáti- co de analito(s), tal como glicose, em fluidos corporais, como na corrente sanguínea ou em fluidos intersticiais ("ISF"), ou outros fluidos biológicos.
Alguns desses dispositivos de medição de analito são configurados de tal modo que pelo menos uma porção dos dispositivos seja posicionada abaixo de uma superfície da pele de um usuário, por exemplo, em um vaso sanguí- neo ou no tecido subcutâneo de um usuário, de tal modo que o monitora- mento seja realizado in vivo.
Com o desenvolvimento continuado de dispositivos e sistemas de monitoramento de analito, há uma necessidade por tais dispositivos, sis- temas e métodos de monitoramento de analito, assim como para propósitos de fabricar dispositivos e sistemas de monitoramento de analito que tenham boa relação custo-benefício, conveniência, e com dor reduzida, proporcio- nem um monitoramento discreto para encorajar o monitoramento frequente de analito de modo a aperfeiçoar o controle glicêmico. 5º SUMÁRIO As modalidades da descrição em questão incluem dispositivos de monitoramento de analito in vivo, sistemas, kits, e processos de monito- ramento de analito e dispositivos de monitoramento de analito de manufatu- ra, sistemas e kits.
Incluem-se dispositivos de monitoramento fisiológico no corpo (isto é, pelo menos uma porção de um dispositivo, sistema ou um componente deste é mantida no corpo de um usuário para monitorar um a- nalito) para medição/monitoramento em tempo real do nível desejado de a- nalito, tal como um nível de glicose durante um ou mais períodos de tempo predeterminados, tal como um ou mais períodos de tempo de monitoramen- to.
As modalidades incluem sensores de analito transcutaneamente posicio- nados que são eletricamente acoplados aos aparelhos eletrônicos propor- cionados em um invólucro que é projetado para que seja fixado ao corpo de um usuário, por exemplo, a uma superfície da pele de um usuário, durante a vida de utilização dos sensores de analito ou períodos de tempo de monito- ramento predeterminados.
Por exemplo, uma montagem de aparelhos ele- trônicos no corpo inclui aparelhos eletrônicos que são operacionalmente a- coplados a um sensor de analito e proporcionados em um invólucro para colocação no corpo de um usuário.
Esse dispositivo e sistema com sensores de analito proporcio- namum monitoramento contínuo ou periódico do nível de analito que é reali- zado automática, ou semi-automaticamente por lógica de controle ou rotinas programadas ou programáveis nos dispositivos ou sistemas de monitora- mento.
Conforme o uso em questão, o monitoramento contínuo, automático, e/ou periódico se refere ao monitoramento ou detecção in vivo dos níveis de —analito com sensores de analito transcutaneamente posicionados.
Em determinadas modalidades, os resultados do nível de analito monitorado in vivo são automaticamente comunicados a partir de uma uni-
dade de aparelhos eletrônicos para outro dispositivo ou componente do sis- tema. Ou seja, quando os resultados estiverem disponíveis, os resultados são automaticamente transmitidos a um dispositivo de exibição (ou outro dispositivo de interação do usuário) do sistema, por exemplo, de acordo com uma programação de comunicação de dados fixa ou dinâmica executada pelo sistema. Em outras modalidades, os resultados do nível de analito mo- nitorado in vivo não são automaticamente comunicados, transferidos ou emi- tidos a um ou mais dispositivos ou componentes do sistema. Nessas moda- lidades, os resultados são proporcionados apenas em resposta a uma con- sultaao sistema. Ou seja, os resultados são comunicados à um componente ou a um dispositivo do sistema apenas em resposta à consulta ou solicitação para tais resultados. Em determinadas modalidades, os resultados do moni- toramento in vivo podem ser registrados ou armazenados em uma memória do sistema e somente comunicados ou transferidos a outro dispositivo ou componente do sistema após um ou mais períodos de tempo de monitora- mento predeterminados.
As modalidades incluem software e/ou hardware para transfor- mar qualquer um dos dispositivos, componentes ou sistemas em qualquer um dos outros dispositivos, componentes ou sistemas, onde tal transforma- ção pode ser configurável por usuário após a fabricação. Os módulos de transformação que incluem hardware e/ou software para realizar tal trans- formação podem ser passível de corresponder a um determinado sistema para transformá-lo.
As modalidades incluem aparelhos eletrônicos acoplados aos Sensores de analito que proporcionam funcionalidades para operar os sen- sores de analito para monitorar os níveis de analito durante um período de tempo de monitoramento predeterminado, tal como, por exemplo, cerca de dias (ou mais em determinadas modalidades), cerca de 14 dias, cerca de 10 dias, cerca de 5 dias, cerca de 1 dia, menos que cerca de 1 dia. Em de- 30 terminadas modalidades, a vida útil de cada sensor de analito pode ser igual ou diferente dos períodos de tempo de monitoramento predeterminados. Os componentes dos aparelhos eletrônicos para proporcionar as funcionalida-
des para operar os sensores de analito em determinadas modalidades inclu- em lógica de controle ou microprocessadores acoplados a uma fonte de e- nergia, tal como uma bateria para acionar os sensores de analito in vivo de modo a realizar reações eletroquímicas para gerar sinais resultantes que correspondem aos níveis de analito monitorados.
Os aparelhos eletrônicos também podem incluir outros compo- nentes, tal como uma ou mais unidades de armazenamento de dados ou memória (volátil e/ou não-volátil), componente(s) de comunicação para co- municar informações correspondentes ao nível de analito monitorado in vivo aum dispositivo de exibição automaticamente quando as informações esti- verem disponíveis, ou seletivamente em resposta a uma solicitação pelas informações monitoradas de nível de analito. A comunicação de dados entre os dispositivos de exibição e as unidades de aparelhos eletrônicos acopla- das ao sensor pode ser serialmente implementada (por exemplo, transferên- ciade dados entre estes não são realizadas ao mesmo tempo), ou em para- lelo. Por exemplo, o dispositivo de exibição pode ser configurado para transmitir um sinal ou pacote de dados aos aparelhos eletrônicos acoplados ao sensor, e mediante a recepção do sinal transmitido ou pacote de dados, os aparelhos eletrônicos acoplados ao sensor se comunicam de volta ao dispositivo de exibição. Em determinadas modalidades, um dispositivo de exibição pode ser configurado para proporcionar energia de RF e da- dos/sinais continuamente, e detectar ou receber um ou mais pacotes de da- dos de retorno ou sinal a partir dos aparelhos eletrônicos acoplados ao sen- sor quando estiver dentro de uma faixa de energia de RF predeterminada a partirdo dispositivo de exibição. Em determinadas modalidades, o dispositi- vo de exibição e os aparelhos eletrônicos acoplados ao sensor podem ser configurados para transmitir um ou mais pacotes de dados ao mesmo tem- po.
Em determinadas modalidades, uma ou mais unidades de arma- zenamento de dados ou memória armazenam dados sob o controle dos apa- relhos eletrônicos. Em determinadas modalidades, uma ou mais unidades de armazenamento de dados ou memória armazenam dados de acordo com um protocolo de armazenamento de dados ativos executado pela lógica de controle ou microprocessadores dos aparelhos eletrônicos. Os dados podem ser ativos de acordo com o tempo e/ou prioridade, ou de outro modo. Por exemplo, um protocolo de armazenamento de dados ativos pode incluir um algoritmo primeiro a entrar/primeiro a sair (FIFO), um algoritmo primeiro a entrar/último a sair (FILO), um algoritmo último a entrar/primeiro a sair (LI- FO), um algoritmo último a entrar/último a sair (LILO). Por exemplo, as mo- dalidades incluem deslocar os dados armazenados mais antigos com os da- dos mais recentes de modo iterativo, ou outras variações de protocolo de dados ativos.
As modalidades incluem sensores de analito in vivo com fonte de alimentação automática que não requerem uma fonte de energia separa- da para operar os sensores de analito para a detecção ou monitoramento do nível de analito. Em outras palavras, descrevem-se sensores com fonte de alimentação automática que proporcionam sua própria energia para opera e não requerem nenhuma outra fonte de energia para monitorar o analito in vivo.
As modalidades também incluem aparelhos eletrônicos progra- mados para armazenar ou registrar em uma ou mais unidades de armaze- —namento de dados ou uma memória associada ao nível de analito monitora- do ao longo da vida útil do sensor ou durante um período de tempo de moni- toramento. Durante o período de tempo de monitoramento, as informações correspondentes ao nível de analito monitorado podem ser armazenadas, mas não exibidas ou emitidas durante a vida útil do sensor, e os dados ar- mazenados podem ser restaurados posteriormente a partir da memória no fim da vida útil do sensor ou após a expiração do período de tempo de moni- toramento predeterminado, por exemplo, para análise clínica, gerenciamento de terapia, etc.
Em determinadas modalidades, o período de tempo de monito- ramento predeterminado pode ser igual ao período de tempo de vida útil do sensor de tal modo que quando uma vida útil do sensor de analito expirar (portanto, não mais usado para monitoramento de nível de analito in vivo), o período de tempo de monitoramento predeterminado finalize. Em determina- das outras modalidades, o período de tempo de monitoramento predetermi- nado pode incluir múltiplos períodos de tempo de vida útil do sensor de tal modo que quando a vida útil do sensor de analito expirar, o período de tem- pode monitoramento predeterminado não tenha finalizado, e o sensor de analito expirado seja substituído por outro sensor de analito durante o mes- mo período de tempo de monitoramento predeterminado. O período de tem- po de monitoramento predeterminado pode incluir a substituição dos múlti- plos sensores de analito para uso.
Em determinadas modalidades, além das informações de nível de analito monitoradas, outras informações podem ser comunicadas a um dispositivo, sistema ou um componente destes, tal como, mas sem limitar-se a, informações de temperatura monitoradas, frequência cardíaca, um ou mais biomarcadores, cromo HbAIC ou similares, informações de nível de analito armazenadas ao longo de um período de tempo, por exemplo, o últi- mo 1 segundo a cerca de 48 horas, por exemplo, o último 1 minuto a cerca de 24 horas, por exemplo, o último 1 minuto a cerca de 10 horas, por exem- plo, as últimas 8 horas, ou as últimas 2 horas, ou a última 1 hora, ou os últi- mos 30 minutos, ou os últimos 15 minutos.
Em determinadas modalidades, as informações de temperatura (in vivo e/ou pele e/ou ambiente) podem ser obtidas e armazenadas na me- mória, por exemplo, a ser usada em um algoritmo para compensar as impre- cisões dependentes da temperatura em níveis de analito monitorados.
As informações de tendência de nível de analito podem ser ge- —radas ou construídas com base nas informações de nível de analito armaze- nadas ao longo de um período de tempo (por exemplo, correspondente a um período de tempo de temperatura, ou outro) e comunicadas ao dispositivo de exibição. As informações de tendência podem ser emitidas gráfica e/ou au- dível e/ou tátil, e/ou numericamente e/ou de outro modo apresentadas em uma interface de usuário do dispositivo de exibição para proporcionar uma indicação da variação do nível de analito durante este período de tempo.
As modalidades incluem comunicar remotamente as informa-
ções de nível de analito a partir de um dispositivo de aparelhos eletrônicos no corpo a um segundo dispositivo, como um dispositivo de exibição. Exem- plos de protocolos de comunicação entre aparelhos eletrônicos no corpo e o dispositivo de exibição podem incluir protocolos de identificação de radiofre- quência (RFID) ou protocolos de comunicação de RF. Os protocolos de RFID exemplificadores incluem, mas não se limitam a, protocolos de comu- nicação de campo próximo que incluem faixas de comunicação curtas (por exemplo, cerca de 30,48 cm (12 polegadas) ou menor, ou cerca de 15,24 cm (6 polegadas) ou menor, ou cerca de 7,62 cm (3 polegadas) ou menor, ou cerca de 5,08 cm (2 polegadas) ou menor), protocolos de comunicação sem fio de alta frequência, protocolos de comunicação de campo afastado (por exemplo, utilizando-se sistemas de comunicação de frequência ultra alta (UHF)) que servem para proporcionar sinais ou dados a partir dos aparelhos eletrônicos no corpo aos dispositivos de exibição.
Os protocolos de comunicação podem usar uma frequência de 433 MHz, uma frequência de 13,56 MHz, uma frequência de 2,45 GHz, ou quaisquer outras frequências adequadas para comunicação sem fio entre os aparelhos eletrônicos no corpo que incluem aparelhos eletrônicos acoplados a um sensor de analito, e dispositivos de exibição e/ou outros dispositivos como um computador pessoal. Embora determinadas frequências de trans- missão de dados e/ou faixas de comunicação de dados sejam descritas an- teriormente, no escopo da presente descrição, outras frequências de trans- missão de dados adequadas e/ou faixas de comunicação de dados podem ser usadas entre os vários dispositivos no sistema de monitoramento de analito.
As modalidades incluem sistemas de gerenciamento de dados que incluem, por exemplo, uma rede de dados e/ou computador pessoal e/ou um terminal servidor e/ou um ou mais computadores remotos que são configurados para receber dados coletados ou armazenados a partir do dis- positivo de exibição para apresentar informações de analito e/ou outro pro- cessamento em conjunto com o monitoramento fisiológico para gerencia- mento da saúde. Por exemplo, um dispositivo de exibição pode incluir uma ou mais portas de comunicação (conectadas ou sem fio) para conexão a uma rede de dados ou um terminal computacional para transferir dados de analito relacionados coletados ou armazenados a outro dispositivo e/ou loca- lização. Os dados relacionados a analito em determinadas modalidades são diretamente comunicados a partir dos aparelhos eletrônicos acoplados ao sensor de analito a um computador pessoal, terminal servidor, e/ou compu- tadores remotos em uma rede de dados. Em determinadas modalidades, proporcionam-se sistemas e mé- todos de calibração "invisível" que determina, concentrações de analito clini- camente precisas pelo menos ao longo do período de captação predetermi- nado dos sistemas de sensor de analito sem obter uma ou mais medições de analito independentes (por exemplo, sem usar uma tira de teste in vitro ou outro dispositivo de referência) para calibração de sinal relacionado a a- nalito gerado a partir do sensor de analito durante a vida útil do sensor, isto é, pós-fabricação. Em outras palavras, uma vez que os sensores de analitos forem posicionados no corpo do usuário, a lógica de controle ou micropro- cessadores nos aparelhos eletrônicos, ou os microprocessadores no disposi- tivo de exibição incluem um ou mais algoritmos ou programação para con- verter ou correlacionar precisamente os sinais relacionados ao analito cap- tado (por exemplo, em nA, contagens, ou outras unidades apropriadas) a um nível de analito correspondente (por exemplo, convertido em um nível de analito em mg/dL ou outras unidades apropriadas) sem um valor de referên- cia proporcionado ao sistema, renderizar a calibração "invisível" do sensor ao usuário de tal modo que o sistema não necessite de nenhuma interven- çãohumana para a calibração do sensor de analito. Estes e outros recursos, objetivos e vantagens da presente des- crição se tornarão aparentes aos indivíduos versados na técnica mediante a leitura dos detalhes da presente descrição conforme descrito de modo mais abrangente abaixo.
BREVE DESCRIÇÃO DOS DESENHOS A figura 1 ilustra um sistema de monitoramento de analito para medição de analito (por exemplo, glicose) em tempo real, aquisição de da-
dos e/ou processamento em determinadas modalidades; As figuras 2A-2B são vistas em perspectiva e vistas em perspec- tiva em corte transversal, respectivamente, do invólucro que inclui um sensor de analito e aparelhos eletrônicos no corpo do sistema na figura 1 em de- terminadas modalidades; A figura 3 ilustra uma placa de circuito impresso (PCB) de apare- lhos eletrônicos no corpo em determinadas modalidades.
A figura 4A ilustra uma vista lateral do invólucro que inclui um sensor de analito e componentes eletrônicos de sensor em determinadas modalidades; A figura 4B ilustra uma vista lateral de um PCB dos aparelhos eletrônicos no corpo montados com um sensor de analito em determinadas modalidades; A figura 5 é uma vista em perspectiva da montagem de compo- nentes eletrônicos mostrada na figura 4B com componentes separados in- cluindo o PCB e o sensor de analito; A figura 6 é uma vista de componente do sensor de analito e dos componentes interconectados da figura 5 em determinadas modalidades; As figuras 7A-7B são vistas em perspectiva do componente in- terconectado da figura 5 em determinadas modalidades; As figuras 8A-8D ilustram aparelhos eletrônicos no corpo inclu- indo um módulo interconectado em determinadas modalidades; As figuras 9A-9) ilustram uma montagem de aparelhos eletrôni- cos no corpo incluindo o sensor de analito, componentes para conexão a um PCB de aparelhos eletrônicos no corpo em determinadas modalidades; A figura 10A ilustra uma vista plana de topo do esboço de ante- na e circuito eletrônico dos aparelhos eletrônicos no corpo do sistema de monitoramento de analito 100 da figura 1 em determinadas modalidades; A figura 10B ilustra uma vista em corte transversal de um esboço de antena e circuito eletrônico dos aparelhos eletrônicos no corpo do siste- ma de monitoramento de analito 100 da figura 1 em determinadas modalida- des;
A figura 11 ilustra uma vista plana de topo do esboço de antena na placa de circuito dos aparelhos eletrônicos no corpo em determinadas modalidades;
As figuras 12A-12C ilustram uma configuração de antena dos aparelhos eletrônicos no corpo em determinadas modalidades;
A figura 13 é uma vista esquemática de um aparelho eletrônico no corpo no sistema de monitoramento de analito 100 da figura 1 em deter- minadas modalidades;
As figuras 14A-15E ilustram as configurações de aparelhos ele-
trônicos no corpo do sistema de monitoramento de analito 100 da figura 1 em determinadas modalidades;
A figura 15 é um diagrama de blocos que ilustra um aparelho e- letrônico no corpo do sistema de monitoramento de analito 100 da figura 1 em determinadas modalidades;
A figura 16 é um diagrama de blocos de aparelhos eletrônicos no corpo no sistema de monitoramento de analito 100 da figura 1 em determi- nadas modalidades;
A figura 17 é uma vista esquemática de um aparelho eletrônico no corpo que inclui um gerador de indução para uso em determinadas moda-
lidades;
A figura 18A ilustra um diagrama de blocos do mecanismo de |i- gamento sem fio para o sistema de monitoramento de analito em determina- das modalidades;
A figura 18B ilustra uma vista esquemática exemplificadora do circuito do mecanismo de ligamento sem fio da figura 18A em determinadas modalidades;
A figura 19 é um fluxograma que ilustra a troca de da- dos/comando entre o dispositivo de exibição e os aparelhos eletrônicos no corpo para executar um procedimento de ligamento sem fio em determina-
das modalidades;
A figura 20 é um diagrama de blocos do dispositivo de exibição da figura 1 em determinadas modalidades;
A figura 21A é uma vista esquemática do dispositivo de exibição da figura 1 em determinadas modalidades; A figura 21B é uma vista esquemática do dispositivo de exibição da figura 1 em determinadas modalidades; As figuras 22 e 23 consistem em um diagrama e um fluxograma, respectivamente, que ilustram um processo para implementar uma comuni- cação sem fio no sistema da figura 1 em determinadas modalidades; A figura 24 é um fluxograma que ilustra uma rotina para determi- nar as informações de expiração do sensor através do dispositivo de exibi- ção 120 para uma combinação aos aparelhos eletrônicos no corpo em de- terminadas modalidades; As figuras 25 e 26 são diagramas de blocos funcionais que ilus- tram as rotinas de processamento de dados do sensor de analito em deter- minadas modalidades; As figuras 27A-27D são fluxogramas das rotinas de processa- mento de dados do sensor de analito em determinadas modalidades; A figura 28 é um fluxograma que ilustra a rotina de notificação de aquisição de dados do sensor de analito em determinadas modalidades; A figura 29 é um fluxograma que ilustra a fabricação baseada na calibração do sensor de analito implementada no processamento de dados do sensor em determinadas modalidades; e As figuras 30A-30D ilustram uma modalidade do módulo de a- quisição de dados de analito para uso com um dispositivo de exibição em determinadas modalidades.
DESCRIÇÃO DETALHADA Antes de a presente descrição ser descrita em detalhes, deve-se compreender que esta descrição não se limita a modalidades particulares descritas, como tais pode, naturalmente, variar. Deve-se compreender, tam- bém, que a terminologia usada no presente documento serve para o propósi- to de descrever apenas modalidades particulares, e não se destina a ser limitante, visto que o escopo da presente descrição será limitado apenas pelas reivindicações em anexo.
Quando se proporcionar uma faixa de valores, deve-se compre- ender que cada valor interveniente, até a décima unidade do limite inferior exceto onde o contexto indicar claramente em contrário, entre o limite supe- rior e inferior desta faixa e qualquer outro valor declarado ou interveniente nesta faixa fixa, é abrangido desta descrição. Os limites superiores e inferio- res dessas faixas menores que podem ser independentemente incluídos nas faixas menores como também abrangidos na descrição, sujeito a qualquer limite especificamente excluído na faixa fixa. Quando a faixa fixa range inclu- ir um ou ambos os limites, as faixas que excluem um ou ambos os limites também são incluídas na descrição.
Exceto onde definido em contrário, todos os termos técnicos e científicos aqui usados têm o mesmo significado conforme comumente com- preendido pelos indivíduos versados na técnica à qual esta descrição per- tence. Embora quaisquer métodos e materiais similares ou equivalentes à- queles descritos no presente documento também possam ser usados na prática ou teste da presente descrição, os métodos e materiais preferenciais serão descritos agora. Todas as publicações aqui mencionadas são incorpo- radas a título de referência e descrevem os métodos e/ou materiais em co- nexão com os quais as publicações são citadas.
Deve-se notar que conforme o uso em questão e nas reivindica- ções em anexo, as formas no singular "um", "uma", "o" e "a" incluem os refe- rentes no plural, exceto onde o contexto indicar claramente em contrário.
As publicações discutidas no presente documento são propor- cionadas somente para sua descrição antes da data de depósito do presente pedido. No presente documento, nada deve ser construído como uma ad- missão que a presente descrição não é intitulada para antedatar tal publica- ção em virtude da descrição anterior. Ademais, as datas de publicação po- dem ser diferentes das datas de publicação reais que podem precisar que sejam independentemente confirmadas.
Conforme ficará aparente aos indivíduos versados na técnica mediante a leitura desta descrição, cada uma das modalidades individuais descritas e ilustradas no presente documento tem componentes e recursos discretos que podem ser prontamente separados ou combinados com os recursos de qualquer uma das outras várias modalidades sem que se divirja do escopo ou espírito da presente descrição.
As figuras mostradas no presente documento não se encontram necessariamente desenhadas em escala, com alguns componentes e recur- sos sendo exagerados para clareza.
Em geral, as modalidades da presente descrição se referem a métodos in vivo e dispositivos que servem para detectar pelo menos analito, tal como glicose em fluido corporal. Consequentemente, as modalidades incluem sensores de analito in vivo configurados de tal modo que pelo me- nos uma porção do sensor seja posicionada no corpo de um usuário (por exemplo, dentro do ISF), de modo a obter informações sobre pelo menos um analito do corpo, por exemplo, posicionado transcutaneamente no corpo do usuário. Em determinadas modalidades, um sensor de analito in vivo é aco- pladoa uma unidade de aparelhos eletrônicos que é mantida no corpo do usuário, tal como em uma superfície da pele, onde tal acoplamento propor- ciona montagens de aparelhos eletrônicos in vivo de sensor de analito no corpo.
Em determinadas modalidades, as informações de analito são comunicadas a partir de um primeiro dispositivo, tal como uma unidade de aparelhos eletrônicos no corpo até um segundo dispositivo que pode incluir recursos de interface de usuário, que incluem uma tela, e/ou similares. As informações podem ser comunicadas a partir do primeiro dispositivo até o segundo dispositivo automática e/ou continuamente quando as informações deanalito estiverem disponíveis, ou não podem ser comunicadas automática e/ou continuamente, mas ao invés disso, armazenadas ou registradas em uma memória do primeiro dispositivo. Consequentemente, em muitas moda- lidades do sistema, as informações de analito derivadas pelo sen- sor/aparelhos eletrônicos no corpo (por exemplo, a montagem de aparelhos eletrônicos no corpo) se tornam disponíveis em uma forma utilizável ou visu- alizável pelo usuário apenas quando consultado pelo usuário de tal modo que a temporização da comunicação de dados seja selecionada pelo usuá-
rio.
Desta maneira, as informações de analito são apenas proporcio- nadas ou evidentes a um usuário (proporcionadas em um dispositivo de in- terface de usuário) quando desejado pelo usuário embora um sensor de analitoin vivo monitore automática e/ou continuamente o nível de analito in vivo, isto é, o sensor monitora automaticamente o analito, tal como a glicose em um intervalo de tempo predefinido ao longo de sua vida útil. Por exem- plo, um sensor de analito pode ser posicionado in vivo e acoplado a apare- lhos eletrônicos no corpo durante um período de captação determinado, por exemplo, cerca de 14 dias. Em determinadas modalidades, as informações de analito derivadas do sensor são automaticamente comunicadas a partir da montagem dos componentes eletrônicos de sensor a um dispositivo de monitoramento remoto ou dispositivo de exibição para emitir a um usuário ao longo do período de 14 dias de acordo com uma agenda programada nos aparelhos eletrônicos no corpo (por exemplo, cerca de a cada 1 minuto ou cerca de a cada 5 minutos ou cerca de a cada 10 minutos, ou similares). Em determinadas modalidades, as informações de analito derivadas do sensor são apenas comunicadas a partir da montagem dos componentes eletrôni- cos de sensor a um dispositivo de monitoramento remoto ou dispositivo de exibição em momentos determinados pelo usuário, por exemplo, sempre que um usuário decidir verificar as informações de analito. Nestes momentos, um sistema de comunicações é ativado e as informações derivadas do sensor são, então, enviadas a partir dos aparelhos eletrônicos no corpo até o dispo- sitivo remoto ou dispositivo de exibição.
Ainda em outras modalidades, as informações podem ser comu- nicadas a partir do primeiro dispositivo até o segundo dispositivo automática e/ou continuamente quando as informações de analito estiverem disponíveis, e o segundo dispositivo armazena ou registra as informações recebidas sem apresentar ou emitir as informações ao usuário. Nessas modalidades, as informações são recebidas pelo segundo dispositivo a partir do primeiro dis- positivo quando as informações se tornarem disponíveis (por exemplo, quando o sensor detectar o nível de analito de acordo com uma agenda de horários). No entanto, as informações recebidas são inicialmente armazena- das no segundo dispositivo e apenas emitidas a uma interface de usuário ou um componente de saída do segundo dispositivo (por exemplo, display) me- diante a detecção de uma solicitação pelas informações sobre o segundo dispositivo.
Consequentemente, em determinadas modalidades, uma vez que uma montagem de componentes eletrônicos de sensor for colocada no corpo de tal modo que pelo menos uma porção do sensor in vivo esteja em contato com um fluxo corporal, tal como ISF e o sensor for eletricamente acoplado à unidade de aparelhos eletrônicos, as informações de analito de- rivadas do sensor podem ser comunicadas a partir dos aparelhos eletrônicos no corpo até um dispositivo de exibição em demanda ligando-se o dispositi- vo de exibição (ou pode ser continuamente acionado), e executando-se um algoritmo de software armazenado e acessado a partir de uma memória do dispositivo de exibição, de modo a gerar um ou mais comandos de solicita- ção, sinal de controle ou pacote de dados para enviar aos aparelhos eletrô- nicos no corpo. O algoritmo de software executado, por exemplo, sob o con- trole do microprocessador ou circuito integrado de aplicação específica (A- SIC) do dispositivo de exibição pode incluir rotinas para detectar a posição dos aparelhos eletrônicos no corpo em relação ao dispositivo de exibição para iniciar a transmissão do comando de solicitação gerado, sinal de con- trole e/ou pacote de dados.
Os dispositivos de exibição também podem incluir uma progra- mação armazenada na memória para execução por um ou mais micropro- cessadores e/ou ASICs para gerar e transmitir um ou mais comandos de solicitação, sinais de controle ou pacotes de dados para enviar aos apare- lhos eletrônicos no corpo em resposta a uma ativação do usuário de um me- canismo de entrada no dispositivo de exibição, tal como pressionando-se um botão no dispositivo de exibição, acionando-se um botão associado à função de comunicação de dados, e assim por diante. O mecanismo de entrada po- de ser alternativa ou adicionalmente proporcionado nos aparelhos eletrôni- cos no corpo que podem ser configurados para ativação do usuário. Em de-
terminadas modalidades, podem-se utilizar comandos de voz ou sinais audí- veis para estimular ou instruir o microprocessador ou ASIC a executar a(s) rotina(s) de software armazenada(s) na memória de modo a gerar e transmi- tir um ou mais comandos de solicitação, sinais de controle ou pacotes de dados ao dispositivo no corpo. Nas modalidades que são ativadas por voz ou em resposta a comandos de voz ou sinais audíveis, os aparelhos eletrô- nicos no corpo e/ou dispositivo de exibição incluem um microfone, um auto- falante, e rotinas de processamento armazenadas nas respectivas memórias dos aparelhos eletrônicos no corpo e/ou do dispositivo de exibição para pro- cessar os comandos de voz e/ou sinais audíveis. Em determinadas modali- dades, o posicionamento do dispositivo no corpo e do dispositivo de exibição a uma distância predeterminada (por exemplo, estrita proximidade) uns em relação aos outros inicia uma ou mais rotinas de software armazenadas na memória do dispositivo de exibição de modo a gerar e transmitir um coman- dode solicitação, sina de controle ou pacote de dados.
Diferentes tipos e/ou formas e/ou quantidades de informações podem ser enviadas para cada leitura em demanda, que incluem, mas não se limitam a, uma ou mais informações atuais de nível de analito (isto é, em tempo real ou informações de nível de analito obtidas mais recentemente, que correspondem temporariamente ao momento em que a leitura é inicia- da), taxa de alteração de um analito ao longo de um período de tempo pre- determinado, razão da taxa de alteração de um analito (aceleração na taxa de alteração), informações históricas de analito correspondentes a informa- ções de analito obtidas antes de uma determinada leitura e armazenada na memória da montagem. Algumas ou todas as informações em tempo real, histórias, razão da taxa de alteração (tal como aceleração ou desaceleração) podem ser enviadas a um dispositivo de exibição para uma leitura determi- nada. Em determinadas modalidades, o tipo e/ou forma e/ou quantidade de informações enviadas a um dispositivo de exibição podem ser pré- programados e/ou inalteráveis (por exemplo, predefinidos na fabricação), ou podem não ser pré-programados e/ou inalteráveis de tal modo que possa ser selecionáveis e/ou alteráveis no campo uma ou mais vezes (por exemplo,
ativando-se um comutador do sistema, etc). Consequentemente, em deter- minadas modalidades, para cada leitura em demanda, um dispositivo de exi- bição emitirá um valor de analito derivado do sensor atual (em tempo real) (por exemplo, em formato numérico), uma taxa atual de alteração de analito (porexemplo, sob a forma de um indicador de taxa de analito, tal como uma seta apontando em uma direção para indicar a taxa atual), e os dados histó- ricos de tendência de analito com base nas leituras do sensor adquiridas e armazenadas na memória dos aparelhos eletrônicos no corpo (por exemplo, sob a forma de um traço gráfico). Adicionalmente, a leitura ou medição de temperatura na pele ou sensor associada a cada leitura em demanda pode ser comunicada a partir dos aparelhos eletrônicos no corpo ao dispositivo de exibição. A leitura ou medição de temperatura, no entanto, pode não ser emitida ou exibida no dispositivo de exibição, mas ao invés disso, usada em conjunto com uma rotina de software executada pelo dispositivo de exibição para corrigir ou compensar a saída de medição de analito ao usuário no dis- positivo de exibição.
Conforme descrito, as modalidades incluem sensores de analito in vivo e aparelhos eletrônicos no corpo que juntos proporcionam montagens componentes eletrônicos de sensor utilizáveis no corpo. Em determinadas modalidades, os sensores de analito in vivo são completamente integrados aos aparelhos eletrônicos no corpo (fixadamente conectados durante a fabri- cação), enquanto em outras modalidades, são separados, porém, conectá- veis pós-fabricação (por exemplo, antes, durante ou após a inserção do sen- sor em um corpo). Os aparelhos eletrônicos no corpo podem incluir um sen- sorde glicose in vivo, aparelhos eletrônicos, uma bateria, e uma antena en- caixada (exceto pela porção de sensor que serve para posicionamento in vivo) em um invólucro à prova d'água que inclui ou é fixável a uma almofada adesiva. Em determinadas modalidades, o invólucro suporta imersão a cerca de um metro sob a água durante até pelo menos 30 minutos. Em determina- das modalidades, o invólucro suporta o contato contínuo sob a água, por exemplo, por mais de cerca de 30 minutos, e continua a funcionar apropria- damente de acordo com seu uso destinado, por exemplo, sem danos causa-
dos pela água aos aparelhos eletrônicos no invólucro onde o invólucro é a- dequado para submersão em água.
As modalidades incluem dispositivos de inserção de sensor, que também podem ser referidos no presente documento como unidades de dis- tribuição de sensor, ou similares. Os dispositivos de inserção podem reter as montagens de aparelhos eletrônicos no corpo completamente em um com- partimento interno, isto é, um dispositivo de inserção pode ser "pré- carregado" com montagens de aparelhos eletrônicos no corpo durante o processo de fabricação (por exemplo, os aparelhos eletrônicos no corpo po- dem ser empacotados em um compartimento interno estéril de um dispositi- vo de inserção). Nessas modalidades, os dispositivos de inserção podem formar pacotes de montagem de sensor (incluindo pacotes estéreis) para montagens de aparelhos eletrônicos no corpo pré-usadas ou novas, e dispo- sitivos de inserção configurados para aplicar montagens de aparelhos ele- trônicos no corpo nos corpos receptores.
As modalidades incluem dispositivos de exibição de mão portá- teis, como dispositivos separados e espaçados a partir de uma montagem de aparelhos eletrônicos no corpo, que coleta informações a partir das mon- tagens e proporciona leituras de analito derivadas do sensor aos usuários.
Esses dispositivos também podem ser referidos como medidores, leitores, monitores, receptores, dispositivos de interface humana, companheiros, ou similares. Determinadas modalidades podem incluir um medidor de analito integrado in vitro. Em determinadas modalidades, os dispositivos de exibição incluem uma ou mais portas comunicações com ou sem fio, tais como USB, serial, paralela, ou similares, configuradas para estabelecer uma comunica- ção entre um dispositivo de exibição e outra unidade (por exemplo, os apare- lhos eletrônicos no corpo, unidade de energia para recarregar uma bateria, um PC, etc). Por exemplo, uma porta de comunicação do dispositivo de exi- bição pode permitir o carregamento de um dispositivo de exibição bateria comum respectivo cabo de carregamento e/ou troca de dados entre um dis- positivo de exibição e seu software de informática compatível.
O software de informática compatível em determinadas modali-
dades inclui, por exemplo, mas não se limita a, um programa de software de gerenciamento de dados autônomo ou habilitado para conexão de rede, re- sidente ou executado em um dispositivo de exibição, computador pessoal, um terminal servidor, por exemplo, para realizar análise de dados, mapea- mento, armazenamento de dados, arquivamento de dados e comunicação de dados, assim como sincronização de dados.
O software de informática em determinadas modalidades também pode incluir um software para execu- tar funções aperfeiçoáveis em campo para aperfeiçoar o firmware de um dispositivo de exibição e/ou unidade de aparelhos eletrônicos no corpo para aperfeiçoar o software residente no dispositivo de exibição e/ou na unidade de aparelhos eletrônicos no corpo, por exemplo, com versões de firmware que incluem recursos adicionais e/ou incluem bugs ou erros fixos de softwa- re, etc.
As modalidades podem incluir um recurso de retroinformações táteis como um motor vibratório, ou similares, configurado de tal modo que notificações correspondentes (por exemplo, uma leitura em demanda bem sucedida recebidas em um dispositivo de exibição) possam ser distribuídas sob a forma de retroinformações táteis.
As modalidades incluem uma programação embutida em um meio legível por computador, isto é, um software de aplicativo baseado em computador (também pode ser referido como software ou programação de informática, ou similares) que processa informações de analito obtidas a par- tir dos dados auto-reportados pelo sistema e/ou usuário.
O software de apli- cativo pode ser instalado em um computador hospedeiro, tal como um tele- fone móvel, PC, um dispositivo de interface humana habilitado à Internet, tal como um telefone habilitado com Internet, assistente pessoal digital, ou simi- lares, através de um dispositivo de exibição ou de uma unidade e aparelhos eletrônicos no corpo.
A programação de informática pode transformar os da- dos adquiridos e armazenados em um dispositivo de exibição ou em uma unidade no corpo para uso por um usuário.
As modalidades da descrição em questão são descritas primari- amente em relação aos dispositivos e sistemas de monitoramento de glico-
se, e métodos de monitoramento de glicose, apenas por motivos de conve- niência e tal descrição não se destina de forma alguma a limitar o escopo da descrição. Deve-se compreender que o sistema de monitoramento de analito pode ser configurado para monitor uma variedade de analitos ao mesmo tempo ou em momentos diferentes.
Por exemplo, os analitos que podem ser monitorados incluem, mas não se limitam a, acetil colina, amilase, bilirrubina, colesterol, gonado- tropina coriônica, creatina quinase (por exemplo, CK-MB), creatina, DNA, fructosamina, glicose, glutamina, hormônios de crescimento, hormônios, ce- tonas, lactato, oxigênio, peróxido, antígeno prostático específico, protrombi- na, RNA, hormônio estimulante de tireóide, e troponina. A concentração de fármacos, como, por exemplo, antibióticos (por exemplo, gentamicina, van- comicina, e similares), digitoxina, digoxina, fármacos de abuso, teofilina, e warfarina, também podem ser monitorados. Nessas modalidades que moni-
15. toram mais de um analito, os analitos podem ser monitorados ao mesmo tempo ou em momentos diferentes, com um único sensor ou com uma plura- lidade de sensores que podem usar os mesmos aparelhos eletrônicos no corpo (por exemplo, simultaneamente) ou com aparelhos eletrônicos no cor- po diferentes.
Conforme descrito em detalhes abaixo, as modalidades incluem dispositivos, sistemas, kits e/ou métodos para monitorar um ou mais parâ- metros fisiológicos, como, por exemplo, mas sem limitar-se a, níveis de ana- lito, níveis de temperatura, frequência cardíaca, nível de atividade do usuá- rio, durante um período de tempo de monitoramento predeterminado. Pro- porcionam-se, também, métodos de fabricação. Os períodos de tempo de monitoramento predeterminados podem ser menores que cerca de 1 hora, ou podem incluir cerca de 1 hora ou mais, por exemplo, cerca de algumas horas ou mais, por exemplo, cerca de alguns dias ou mais, por exemplo, cerca de 3 ou mais dias, por exemplo, cerca de 5 dias ou mais, por exemplo, cerca de 7 dias ou mais, por exemplo, cerca de 10 dias ou mais, por exem- plo, cerca de 14 dias ou mais, por exemplo, cerca de várias semanas, por exemplo, cerca de 1 mês ou mais. Em determinadas modalidades, após a expiração do período de tempo de monitoramento predeterminado, um ou mais recursos do sistema podem ser automaticamente desativados ou de- sabilitados na montagem de aparelhos eletrônicos no corpo e/ou dispositivo de exibição.
Por exemplo, um período de tempo de monitoramento predeter- minado pode iniciar com o posicionamento do sensor in vivo e em contato com um fluido corporal, como ISF, e/ou com a iniciação (ou acionamento do modo operacional completo) dos aparelhos eletrônicos no corpo. A inicializa- ção dos aparelhos eletrônicos no corpo pode ser implementada por um co- mando gerado e transmitido por um dispositivo de exibição em resposta à ativação de um comutador e/ou colocando-se o dispositivo de exibição a uma distância predeterminada (por exemplo, estrita proximidade) aos apare- lhos eletrônicos no corpo, ou por ativação manual do usuário de um comuta- dor na unidade de aparelhos eletrônicos no corpo, por exemplo, pressionan- do-se um botão, ou tal ativação pode ser causada pelo dispositivo de inser- ção, por exemplo, conforme descrito no Pedido de Patente U.S. No. 12/698.129 depositado em 1 de fevereiro de 2010 e nos Pedidos Provisórios U.S. Nos. 61/238.646, 61/246.825, 61/247.516, 61/249.535, 61/317.243, 61/345.562, e 61/361.374, estando as descrições de cada uma dessas aqui incorporadas a título de referência para todos os propósitos.
Quando inicializado em resposta a um comando recebido a partir de um dispositivo de exibição, os aparelhos eletrônicos no corpo restauram e executam a partir de sua rotina de software de memória para acionar com- pletamente os componentes dos aparelhos eletrônicos no corpo, colocando- se efetivamente os aparelhos eletrônicos no corpo em um modo operacional completo em resposta ao recebimento do comando de ativação proveniente do dispositivo de exibição. Por exemplo, antes do recebimento do comando proveniente do dispositivo de exibição, uma porção dos componentes nos aparelhos eletrônicos no corpo pode ser acionada por sua fonte de energia interna, tal como uma bateria enquanto outra porção dos componentes nos aparelhos eletrônicos no corpo pode ser desligada ou ter pouco ou nenhuma energia, modo inativo, ou todos os componentes podem estar em um modo inativo, modo desligado. Mediante o recebimento do comando, a porção res- tante dos componentes (ou todos) dos aparelhos eletrônicos no corpo é co- mutada para ativar o modo completamente operacional.
As modalidades dos aparelhos eletrônicos no corpo podem in- cluiruma ou mais placas de circuito impresso com aparelhos eletrônicos que incluem uma lógica de controle implementada em ASIC, microprocessado- res, memória, e similares, e os sensores de analito transcutaneamente posi- cionados formando uma única montagem. Os aparelhos eletrônicos no corpo podem ser configurados para proporcionar um ou mais sinais ou pacotes de dados associados a um nível de analito monitorado mediante a detecção de um dispositivo de exibição do sistema de monitoramento de analito a uma proximidade predeterminada durante um período de tempo (por exemplo, cerca de 2 minutos, por exemplo, 1 minuto ou menos, por exemplo, cerca de 30 segundos ou menos, por exemplo, cerca de 10 segundos ou menos, por exemplo, cerca de 5 segundos ou menos, por exemplo, cerca de 2 segundos ou menos) e/ou até que uma confirmação, tal como uma notificação audível e/ou visual e/ou tátil (por exemplo, vibratória) seja emitida no dispositivo de exibição indicando uma aquisição bem sucedida do sinal relacionado a anali- to proveniente dos aparelhos eletrônicos no corpo. Uma notificação diferente também pode ser emitida para uma aquisição mal sucedida em determina- das modalidades.
Em determinadas modalidades, o nível de analito monitorado pode ser correlacionado e/ou convertido em níveis de glicose no sangue ou outros fluidos, como ISF. Essa conversão pode ser realizada com os apare- lhos eletrônicos no corpo, porém, em muitas modalidades será realizada com os aparelhos eletrônicos do dispositivo de exibição. Em determinadas modalidades, o nível de glicose é derivado a partir do nível de analito moni- torado no ISF.
Os sensores de analito podem ser inseríveis a uma veia, artéria, ou outra porção do corpo contendo analito. Em determinadas modalidades, os sensores de analito podem ser posicionados em contato com o ISF de modo a detectar o nível de analito, onde o nível de analito detectado pode ser usado para inferir o nível de glicose do usuário no tecido sanguíneo ou intersticial. As modalidades incluem sensores transcutâneos e, também, sensores totalmente implantáveis e montagens totalmente implantáveis nas quais uma única montagem que inclui o sensor de analito e os aparelhos eletrônicos são proporcionados em um invólucro vedado (por exemplo, invó- lucro biocompatível hermeticamente vedado) para implantação no corpo de um usuário para monitoramento de um ou mais parâmetros fisiológicos. Modalidades de Sistemas de Monitoramento de Analito In Vivo A figura 1 mostra um sistema de monitoramento de analito ba- seado in vivo 100 exemplificador de acordo com modalidades da presente descrição. Conforme mostrado em determinadas modalidades, o sistema de monitoramento de analito 100 inclui aparelhos eletrônicos no corpo 110 ele- tricamente acoplados ao sensor de analito in vivo 101 (sendo que uma por- ção proximal deste é mostrada na figura 1) e fixados à camada adesiva 140 para fixação a uma superfície da pele no corpo de um usuário. Os aparelhos eletrônicos no corpo 110 incluem um invólucro no corpo 119, que define um compartimento interno. Da mesma forma, conforme mostrado na figura 1 encontra-se um dispositivo de inserção 150 que, quando operado, posiciona transcutaneamente uma porção do sensor de analito 101 através de uma superfície da pele e em contato fluídico com o ISF, e posiciona os aparelhos eletrônicos no corpo 110 e à camada adesiva 140 sobre uma superfície da pele. Em determinadas modalidades, os aparelhos eletrônicos no corpo 110, o sensor de analito 101 e a camada adesiva 140 são vedados dentro do in- vólucro do dispositivo de inserção 150 antes do uso, e em determinadas modalidades, a camada adesiva 140 também é vedada dentro do invólucro ou ela própria proporciona uma vedação terminal do dispositivo de inserção
150. Os dispositivos, sistemas e métodos que podem ser usados com as modalidades aqui apresentadas são descritos, por exemplo, no Pedido de Patente U.S. No. 12/698.129 e nos Pedidos Provisórios U.S. Nos. 61/238.646, 61/246.825, 61/247.516, 61/249.535, 61/317.243, 61/345.562, e 61/361.374, estando as descrições de cada uma dessas aqui incorporadas a título de referência para todos os propósitos.
Reportando-se novamente à figura 1, o sistema de monitora- mento de analito 100 inclui dispositivo de exibição 120 que inclui uma tela 122 para emitir informações ao usuário, um componente de entrada 121, tal como um botão, um atuador, um comutador sensível ao toque, um comuta- dor capacitivo, um comutador sensível à pressão, um botão rotativo ou simi- lares, para inserir dados ou comandos ao dispositivo de exibição 120 ou, de outro modo, controlar a operação do dispositivo de exibição 120. Nota-se que algumas modalidades podem incluir dispositivos desprovidos de tela ou dispositivos sem quaisquer componentes de interface de usuário. Estes dis- positivos podem ser funcionalizados para armazenar dados como um aquisi- tor de dados e/ou proporcionar um conduto para transferir dados a partir de aparelhos eletrônicos no corpo e/ou um dispositivo desprovido de tela até outro dispositivo e/ou localização. No presente documento, as modalidades serão descritas como dispositivos de exibição para propósitos exemplificado- res que não são destinados de forma alguma a limitarem as modalidades da presente descrição. Tornar-se-á aparente que os dispositivos desprovidos de tela também podem ser usados em determinadas modalidades. Em determinadas modalidades, os aparelhos eletrônicos no cor- po1ll10 podem ser configurados para armazenar alguns ou todos os dados monitorados relacionados a analito recebidos a partir do sensor de analito 101 em uma memória durante um período de tempo de monitoramento, e mantê-los em memória até que o período de utilização termine. Nessas mo- dalidades, os dados armazenados são restaurados a partir dos aparelhos eletrônicos no corpo 110 na conclusão do período de tempo de monitora- mento, por exemplo, após a remoção do sensor de analito 101 a partir do usuário destacando-se os aparelhos eletrônicos no corpo 110 da superfície da pele onde estavam posicionados durante o período de tempo de monito- ramento. Nessas configurações de registro de dados, o nível de analito mo- nitorado em tempo real não é comunicado ao dispositivo de exibição 120 durante o período de monitoramento ou, de outro modo, transmitido a partir dos aparelhos eletrônicos no corpo 110, mas ao invés disso, restaurados a
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Em determinadas modalidades, o componente de entrada 121 do dispositivo de exibição 120 pode incluir um microfone e o dispositivo de exibição120 pode incluir um software configurado para analisar a entrada de áudio recebida a partir do microfone, de tal modo que as funções e a opera- ção do dispositivo de exibição 120 possam ser controladas por comandos de voz. Em determinadas modalidades, um componente de saída do dispositivo de exibição 120 inclui um auto-falante que serve para emitir informações como sinais audíveis. Os componentes responsivos por voz similares, como um auto-falante, um microfone e rotinas de software para gerar, processar e armazenar sinais acionados por voz podem ser proporcionados aos apare- lhos eletrônicos no corpo 110. Em determinadas modalidades, a tela 122 e o componente de entrada 121 podem ser integrados em um único componente, por exemplo, uma tela que pode detectar a presença e a localização de um toque de con- tato físico na tela, tal como uma interface de usuário de tela sensível ao to- que. Nessas modalidades, o usuário pode controlar a operação do dispositi- vo de exibição 120 utilizando-se um conjunto de comandos de movimento pré-programados, que incluem, mas não se limitam a, tocar uma ou duas vezes na tela, arrastar um dedo ou instrumento ao longo da tela, direcionar vários dedos ou instrumentos uns em direção aos outros, direcionar vários dedos ou instrumentos uns afastando-se dos outros, etc. Em determinadas modalidades, uma tela inclui uma tela sensível ao toque tendo áreas de pi- xelscom elementos capacitivos de função única ou dupla que servem como elementos de LCD e sensores sensíveis ao toque.
O dispositivo de exibição 120 também inclui uma porta de comu- nicação de dados 123 para comunicação de dados com fio com dispositivos externos, como um terminal remoto (computador pessoal) 170, por exemplo.
As modalidades exemplificadoras da porta de comunicação de dados 123 incluem uma porta USB, uma mini-porta USB, uma porta RS-232, uma porta Ethernet, uma porta Firewire, ou outras portas de comunicação de dados
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