BRPI0802279A2 - non-invasive intracranial pressure monitoring equipment (pic) - Google Patents
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Abstract
EQUIPAMENTO NçO INVASIVO PARA MONITORAMENTO DA PRESSçO INTRACRANIANA (PIO). O presente invento diz respeito a um equipamento para monitoramento da pressão intracraniana (PIC), compreendido por um sensor de deformação denominado de extensômetro ou strain gauge (2), instalado externamente no osso do crânio do paciente (1); e, um módulo analógico para digital (4) para ler o sinal provindo do sensor (3), digitalizá-lo e transferir estes dados para um registrador ou plotter (5) ou um microcomputador e/ou monitor de parâmetros médicos (6).NON-INVASIVE EQUIPMENT FOR INTRACRANIAL PRESSURE (PIO) MONITORING. The present invention relates to an intracranial pressure monitoring (PIC) apparatus comprising a strain gauge sensor called an extensometer or strain gauge (2), which is externally mounted to the patient's skull bone (1); and an analog to digital module (4) for reading the signal from sensor (3), digitizing it and transferring this data to a recorder or plotter (5) or a microcomputer and / or medical parameter monitor (6).
Description
EQUIPAMENTO NÃO INVASIVO PARA MONITORAMENTO DAPRESSÃO INTRACRANIANA (PIC)NON-INVASIVE INTRACRANIAL DAPRESSION (PIC) MONITORING EQUIPMENT
Campo da invençãoField of the invention
O presente invento diz respeito a um equipamento paramonitoramento da pressão intracraniana (PIC), utilizado na área dasaúde humana ou animal, tais como: Neurologia e neurocirurgia,pesquisas básicas para entendimento da PIC em animais e humanos;e, Pesquisas básicas aplicadas à novas áreas, como fisiologia,farmacologia, imunologia, endocrinologia e outras a sereminvestigadas, baseadas na observação da PIC em modelosexperimentais in vivo.The present invention relates to intracranial pressure monitoring (PIC) equipment used in the field of human or animal health, such as: Neurology and neurosurgery, basic research for understanding PIC in animals and humans, and Basic research applied to new areas. , such as physiology, pharmacology, immunology, endocrinology and others to be investigated, based on the observation of ICP in experimental models in vivo.
Estado da técnicaState of the art
Através de buscas realizadas em diversas bases de patentessão encontradas algumas propostas de métodos não invasivos paramedir pressão intracraniana, cujos métodos e equipamentos sãopreviamente demonstrados abaixo:Through searches carried out in various patent bases found some proposals of noninvasive methods to measure intracranial pressure, whose methods and equipment are previously shown below:
- US 4.204.547 revela um equipamento e método de Medidaseletromagnéticas de mudança do fluxo dentro da veia jugular;US 4,204,547 discloses an equipment and method of electromagnetic measurements of flow change within the jugular vein;
- US 4.564.022, apresenta um equipamento e método deMedidas das mudanças da atividade elétrica do cérebro após- US 4,564,022, presents an equipment and method for measuring changes in brain electrical activity following
estímulo com luz nos olhos;stimulation with light in the eyes;
- US 4.971.06, demonstra um equipamento e método deMedidas da amplitude dos ecos de interferência de Medidas daamplitude dos ecos de interferência de ultra-som refletidos pela dura-máter;- US 4,971.06, demonstrates an equipment and method of measuring the interference echo amplitude Measurements of the amplitude of the ultrasound interference echoes reflected by the dura mater;
- US 5.117.835, demonstra um equipamento e método deMedidas da atenuação do ultra-som nos ossos de crânio e análisedos sinais dos espectros;- US 5.388.583, revela um equipamento e método deTransmissão do pulso de ultra-som no meio intracraniano e medidasdo tempo de resposta;- US 5,117,835, demonstrates an equipment and method of measuring ultrasound attenuation in skull bones and analyzing spectral signals; - US 5,388,583, discloses an equipment and method of Transmitting the ultrasound pulse in the intracranial environment; response time measurements;
- US 5.617.873, apresenta um equipamento e método demedidas da fase do sinal de ultra-som refletido pelos lados extremosdo crânio;US 5,617,873, discloses a measurement equipment and method of the ultrasound signal phase reflected by the extreme sides of the skull;
- WO 97/30630, apresenta um equipamento e método análiseda forma de onda dos sinais tendo como característica a resistênciaelétrica do crânio;WO 97/30630, discloses a signal waveform analysis apparatus and method having as characteristic the electrical resistance of the skull;
- US. 5.919.144, demonstra um equipamento e método deTransmissão de sinal acústico de baixa freqüência através do crânioe aplicação de análises espectrais aos sinais detectados;- US 5,919,144, demonstrates a low frequency acoustic signal transmission equipment and method through the skull and application of spectral analysis to the detected signals;
- US 5.993.398, apresenta um equipamento e método decontraste de fase das imagens obtidas por ressonância magnética,tendo com característica o fluxo sangüíneo nas veias e artérias efluxo do líquido cerebro-espinhal;- US 5,993,398, discloses a phase-contrast equipment and method of magnetic resonance imaging, having the characteristic blood flow in the veins and arteries and cerebrospinal fluid outflow;
- WO 99/65387, demonstra um equipamento e método medidassimultâneas da saturação de 02 nas veias oculares, da pressão intra-ocular e ciclo cardíaco;WO 99/65387, discloses a simultaneous measurement equipment and method of ocular vein O 2 saturation, intraocular pressure and cardiac cycle;
- US. 5.951.477, revela um equipamento e técnica para medidasde fluxo sangüíneo por Doppler de 2a. Camada;- US No. 5,951,477, discloses an equipment and technique for 2a Doppler blood flow measurements. Layer;
- US. 6.086.533, apresenta equipamento para as medidas defluxo sangüíneo nas veias intracranianas por ultra-som;- US 6,086,533, presents equipment for the measurement of blood flow in the intracranial veins by ultrasound;
- US. 6.129.682, revela um equipamento de tomografia do nervoóptico, caracterizado por obter parâmetros do nervo ótico;- US. 6.117.089, apresenta um equipamento de geração edetecção de ondas estacionárias nos ossos do crânio e medidas dasdiferenças de fase entre o sinal oscilatório transmitido e o recebido; e,- US No. 6,129,682, discloses a nerve-tomography equipment characterized by obtaining optic nerve parameters; 6,117,089, discloses a stationary wave generation and detection equipment in the skull bones and measures of phase differences between the transmitted and received oscillatory signals; and,
- WO 0068467, demonstra um equipamento de análise dasondas do pulsograma de eco tendo como característica a ecografiado terceiro ventrículo cerebral.WO 0068467, demonstrates an echo pulsogram probe analysis equipment having the ultrasound of the third cerebral ventricle as a feature.
Por outro lado, um certo número de métodos para a medida daPressão Intracraniana (PIC) foram publicados nos últimos anos,dentre os quais destacamos o método do pesquisador PairaudeauOn the other hand, a number of methods for measuring intracranial pressure (ICP) have been published in recent years, among which we highlight the method of researcher Pairaudeau.
(Pairaudeau at al, 1990) que desenvolveu.um equipamento para amedida da PIC através da fontanela de recém nascidos, baseado nadeformação que ocorre nesta área e relacionando-a diretamente coma pressão dentro do cérebro. O equipamento baseia-se na leitura dadeformação de uma membrana, na qual é colado um strain gauge,sendo que esta membrana é colocada em contato com a parte centralda fontanela anterior de recém nascidos. Entretanto, este método sóse aplica aos recém nascidos que apresentem hidrocefalia, nãopodendo ser utilizado em pacientes cuja fontanela já tenha seconsolidado.(Pairaudeau at al, 1990) who developed a device for measuring ICP through the fontanelle of newborns, based on the formation occurring in this area and relating it directly to pressure within the brain. The equipment is based on the reading of the formation of a membrane, on which a strain gauge is glued, and this membrane is placed in contact with the central part of the anterior fontanelle of newborns. However, this method only applies to newborns with hydrocephalus and cannot be used in patients whose fontanelle has already solidified.
A utilização de extensômetros, como são chamados os straingauges, acoplados diretamente a ossos, tanto de animais quanto deseres humanos, para a medida de sua deformação quandosubmetidos a cargas ou a esforços, foi largamente citada emliteraturas científicas. Já em 1944, Gurdjian e Lissner publicaramseus primeiros trabalhos descrevendo o uso do strain gauge em ossovivo. O strain gauge foi colado com polimetilmetacrilato (PMMA), nocrânio de um animal de teste anestesiado, onde foi coletada a medidada deformação do osso in vivo.Lanyon e Smith (Lanyon e Smith, 1970), foram os primeiros apublicar, como parte de um estudo, uma descrição minuciosa depreparação e técnicas de colocação de strain gauge in vivo. Em seuestudo, foram utilizados fios encapados com poliéster e foramcolados com isobutílico 2-cianoacrilato à tíbia de ovinos vivos e foramfeitas medições durante sua marcha. No entanto, este estudoapresentou problemas causados pelos circuitos elétricos edispositivos de gravação. Um condicionamento de sinal baseado emcorrente alternada (AC) foi utilizado em conjunto com strain gaugesemicondutores de alta resistência (Lanyon, 1971), eliminando oproblema. Strain gauge tipo Foil foram utilizados pela primeira vez em1972 (Cochran, 1972). Foi observado que este procedimento eramais fácil e causava menos danos ao osso e tecidos circundantes(Lanyon, 1973). Estudos utilizando strain gauges tipo Foil, foramrealizados em vários tipos de animais e em humanos. Strain gaugescolados com isobutílico 2 cianoacrilato na tíbia de seres humanos,foram utilizados para a coleta de dados durante a marcha (Lanyon,1975).The use of strain gauges, as the straingauges are called, coupled directly to bones of both animals and humans to measure their deformation when subjected to loads or stresses, has been widely cited in scientific literature. Already in 1944, Gurdjian and Lissner published their first works describing the use of strain gauge in ossovivo. The strain gauge was glued with polymethyl methacrylate (PMMA), nocranium from an anesthetized test animal, where the measured bone deformation was collected in vivo. Lanion and Smith (Lanyon and Smith, 1970) were the first to publish as part of a study, a thorough description of preparation, and in vivo strain gauge placement techniques. In his study, polyester-covered threads were used and were glued with isobutyl 2-cyanoacrylate to the tibia of live sheep and measurements were taken during their gait. However, this study presented problems caused by the electrical circuits and recording devices. Alternating current (AC) -based signal conditioning was used in conjunction with high-resistance strain gauges (Lanyon, 1971), eliminating the problem. Strain gauge type Foil were first used in 1972 (Cochran, 1972). It was observed that this procedure was easier and caused less damage to bone and surrounding tissues (Lanyon, 1973). Studies using Foil strain gauges have been performed on various types of animals and humans. Strains gaugescolados with isobutyl 2 cyanoacrylate in the tibia of humans were used for data collection during gait (Lanyon, 1975).
O primeiro a relatar o uso de strain gauges em seres humanos(embora tenha sido anexado a uma prótese e não diretamente aoosso), foi Rydell em 1966, (Rydell, 1966). Neste estudo, strain gaugesforam fixados a uma prótese femoral antes de ter sido implantada.The first to report the use of strain gauges in humans (although it was attached to a prosthesis and not directly to the bone) was Rydell in 1966 (Rydell 1966). In this study, strain gauges were attached to a femoral prosthesis before it was implanted.
A prova de que o strain gauge colocado in vivo, poderia medir afisiologia da deformação óssea, foi obtida quando foram25 correlacionados os dados obtidos por leituras apresentadas poracelerômetros e potencial elétrico. Um destes estudos mostra umarelação linear entre a carga na superfície do osso e sua deformaçãodurante uma caminhada. Mais tarde, a extensometria óptica foiutilizada durante carregamento de um osso recém explantado deanimais, que tinham sido usados para medições in vivo, paravalidação da medida do strain gauge (Baggott and Lanyon, 1977).Carter et al. (1980), também demonstraram a acurácia entre amedida da deformação de um osso monitorado in vivo e depoisexplantado e encharcado em solução salina por uma semana.The proof that the strain gauge placed in vivo could measure the physiology of bone deformation was obtained when the data obtained by readings presented by accelerometers and electrical potential were correlated. One of these studies shows a linear relationship between the load on the bone surface and its deformation during walking. Optical extensometry was later used during loading of a newly explanted bone that had been used for in vivo measurements to validate the strain gauge measurement (Baggott and Lanyon, 1977). Carter et al. (1980), also demonstrated the accuracy between the measure of the deformation of a bone monitored in vivo and then explored and soaked in saline for one week.
In vitro, strain gauges tem sido utilizados para medir adeformação de ossos desde as proximidades de 1950. Lambertrelatou que sensores podem ser instalados diretamente à superfíciedo osso cortical úmido e descreve métodos de impermeabilizaçãodos transdutores e fios. No estudo de Lambert, a deformação ecapacidade de suportar peso da tíbia e perônio foram medidas(Lambert, 1971).In vitro strain gauges have been used to measure bone conformation since the early 1950s. He also reported that sensors can be installed directly to the surface of moist cortical bone and describes methods for waterproofing transducers and wires. In Lambert's study, deformation and ability to support tibia and fibula weight were measured (Lambert, 1971).
Em alguns destes estudos, a superfície óssea foi seca antes dacolagem do strain gauge. Além disso, procedimentos como a limpeza,a raspagem, o desengorduramento, e a desidratação da superfície,foram realizados antes da colagem. Um relatório sobre a aplicação detransdutores em ossos in vitro, mostrou que técnicas de raspagem edesengorduramento criam danos visíveis à superfície do osso (Wrigthe Hayes, 1979). O autor conclui que esta técnica foi aceitável parapreparação de estudos in vitro, produzindo uma boa colagem.Entretanto, ela é muito agressiva para a utilização em estudos in vivo.O dano criado na superfície pode causar uma resposta deremodelação ou cicatrização óssea, que iria alterar as propriedades epoderá recrutar células que degradam e retiram o adesivo maisrapidamente.In some of these studies, the bone surface was dried prior to strain gauge cracking. In addition, procedures such as cleaning, scraping, degreasing, and surface dehydration were performed prior to bonding. A report on the application of bone transducers in vitro showed that scraping and degreasing techniques create visible damage to the bone surface (Wrigthe Hayes, 1979). The author concludes that this technique was acceptable for preparation of in vitro studies, producing good bonding. However, it is very aggressive for use in in vivo studies. Surface damage can cause a bone remodeling or healing response that would alter The properties will recruit cells that degrade and remove the adhesive more quickly.
Por volta de 1979, grande interesse nas medições dasdeformações fisiológicas e avanços nos strain gauges e novastecnologias para adesivos, levaram à proliferação de casos demedida de deformação em ossos. Procedimentos in vitro, foramutilizados para determinar o comportamento mecânico de ossos sobdiversas condições de carregamento (Huiskies, 1982, Gies e Carter,1982). Eles também utilizaram o sistema para avaliar o efeito dedoenças e procedimentos cirúrgicos ou implantes sobre deformaçãoem amostras (Finlay et al., 1986, Arner and Hagberg, 1984). Medidasde deformação in vivo, foram usadas para comparar os efeitosocorridos em ossos submetidos a um carregamento padrão, com afinalidade de avaliação anatômica e histológica do osso, paraexaminar os aspectos evolutivos quanto sua forma e paracorrelacionar com a mudança de deformação, induzida por implantes(Carter et al., 1981, Lanyon et al., 1981). Deformações em ossostambém foram medidas utilizando protocolos de exercício, em umavariedade de mamíferos e pássaros, e também para o estudo deremodelação em ambientes com microgravidade (Keller andSpengler, 1982; Szivek et al., 1995).By 1979, great interest in the measurement of physiological deformations and advances in strain gauges and new adhesive technologies led to the proliferation of measured cases of bone deformation. In vitro procedures were used to determine the mechanical behavior of bones under various loading conditions (Huiskies, 1982, Gies and Carter, 1982). They also used the system to assess the effect of fingerprints and surgical procedures or implants on strain on samples (Finlay et al., 1986, Arner and Hagberg, 1984). In vivo deformation measures were used to compare the effects on bones subjected to standard loading, with the purpose of anatomical and histological evaluation of the bone, to examine the evolutionary aspects of bone shape and to correlate with implant-induced deformation change (Carter et al. al., 1981, Lanyon et al., 1981). Bone deformations were also measured using exercise protocols in a variety of mammals and birds, and also for the study of remodeling in microgravity environments (Keller and Spengler, 1982; Szivek et al., 1995).
Sob o aspecto da utilização de extensometria in vivo, ainda seránecessário um significativo desenvolvimento. Adesivos a base decianoacrilato degradam-se no ambiente corpóreo dentro de umperíodo de 2 a 3 semanas, levando imprecisões às medidas. Umapermanente busca de melhoria de métodos de colagem de straingauges em ossos in vivo, levou a três abordagens. Uma abordagemseria a utilização de adesivos dentários, originalmente usados emsuperfícies com esmalte. Page et al. (1993), relatou seu sucesso nautilização desta abordagem, na colagem de um transdutor em um cãomodelo. A segunda abordagem tem sido utilizada com sucesso emanimais e humanos utilizando o polimetilmetacrilato (PMMA), masrequer que a superfície do osso seja raspada ou perfurada e lixada(Szivek, 1984). Uma abordagem mais promissora para a realizaçãode medidas de mais longo prazo, seria a utilização de partículas defosfato de cálcio cerâmico (CPC), coladas ao strain gauge (Szivek etal., 1990; Szivek et al., 1997). Esta abordagem tem sido utilizada comsucesso para medidas de deformação in vivo, de até 16 semanas 68.Além disso, outros estudos (Battraw et al., 1998), têm mostrado que aresistência do CPC, como interface entre strain gauge e os ossos,permanecem constantes por um período de até 9 meses, in vivo.Regarding the use of in vivo extensometry, significant development will still be required. Decyanacrylate-based adhesives degrade in the body environment within 2 to 3 weeks, leading to inaccuracies in measurements. A continuing pursuit of improved bone bonding methods for straingauges in vivo has led to three approaches. One approach would be to use dental adhesives, originally used on enamel surfaces. Page et al. (1993), reported their success in using this approach, in gluing a transducer in a model dog. The second approach has been successfully used in humans and humans using polymethyl methacrylate (PMMA), but requires the bone surface to be scraped or punctured and sanded (Szivek, 1984). A more promising approach for longer-term measurements would be the use of ceramic calcium phosphate (CPC) particles bonded to the strain gauge (Szivek etal., 1990; Szivek et al., 1997). This approach has been successfully used for in vivo strain measurements of up to 16 weeks 68. In addition, other studies (Battraw et al. 1998) have shown that CPC resistance, as an interface between strain gauge and bones, remains constant for up to 9 months in vivo.
Estes fatos relatados até o momento demonstram a viabilidadee biocompatibilidade de nosso sistema de monitoramento da pressãointracraniana (PIC), sendo que até a presente data não houve relatosda utilização direta de extensômetros colados no osso cranianoíntegro e associados com a leitura da PIC.These facts reported so far demonstrate the viability and biocompatibility of our intracranial pressure monitoring (ICP) system, and to date there have been no reports of the direct use of extensometers attached to the cranial bone and associated with ICP reading.
Os sistemas existentes no mercado utilizam um sensorinvasivo, que é instalado no interior da caixa craniana (fig. 1). Estessensores podem ser instalados diretamente no ventrículo cerebral,parênquima nervoso ou espaço subaracnóideo.Commercially available systems use an invasive sensor, which is installed inside the cranial casing (fig. 1). Stressors may be installed directly into the cerebral ventricle, nervous parenchyma, or subarachnoid space.
Estes métodos incluem penetração no crânio e inserção atravésdele e da dura-máter de um cateter para realização da medida. Esteprocedimento expõe o paciente a riscos de precipitação dehematoma intracraniano, de agravar o edema cerebral, danificar o20 parênquima, hemorragia intracerebral e promover infecçãointracraniana, sendo a última a mais comum das complicações.These methods include penetration into the skull and insertion through and through the dura of a catheter for measurement. This procedure exposes the patient to the risk of intracranial hematoma precipitation, aggravating cerebral edema, damaging the parenchyma, intracerebral hemorrhage, and promoting intracranial infection, the latter being the most common of complications.
O custo dos métodos hoje existentes na clínica é outro fato aser considerado, os valores destes recursos são proibitivos para ainclusão destes procedimentos na rotina do SUS, privandoaproximadamente 125.000 brasileiros/ano de um melhor diagnósticoe acompanhamento médico.The cost of existing methods in the clinic is another fact to be considered, the values of these resources are prohibitive for the inclusion of these procedures in the SUS routine, depriving approximately 125,000 Brazilians / year of a better diagnosis and medical follow-up.
Os métodos atuais para monitoração da PIC exigemprocedimentos cirúrgicos para a implantação do sensor, limitando osmétodos aos grandes centros médicos com salas cirúrgicasadequadas e corpo clínico especializado.Current methods for ICP monitoring require surgical procedures for sensor implantation, limiting methods to large medical centers with adequate operating rooms and specialized clinical staff.
Há também a tentativa de relacionar os valores da pressãointracraniana com imagens de tomografia computadorizada,avaliando a deformação nas estruturas cerebrais ou irregularidadesno volume do líquor; esta técnica é pouco utilizada pois a observaçãode tais sinais só é possível após grandes variações da PIC, muitasvezes sendo tarde para o paciente.There is also an attempt to relate intracranial pressure values to computed tomography images, assessing deformation in brain structures or irregularities in CSF volume; This technique is rarely used because observation of such signs is only possible after large variations in ICP, often being late for the patient.
Descrição do InventoDescription of the Invention
O equipamento ora reivindicado é constituído por um sensor dedeformação denominado de extensômetro ou strain gauge (2),instalado externamente no osso do crânio do paciente (epicraniano);e, um módulo analógico para digital (4) para ler o sinal provindo dosensor, digitalizá-lo e transferir estes dados para um registrador ouplotter (5) ou um microcomputador e/ou monitor de parâmetrosmédicos (6).The equipment now claimed consists of a strain gauge sensor called an extensometer or strain gauge (2), installed externally on the patient's skull bone (epicranial), and an analog to digital module (4) to read the signal from the dosensor, digitize it. it and transfer this data to a recorder or plotter (5) or a microcomputer and / or medical parameter monitor (6).
O sensor (2) é colado à superfície óssea (2) com cianoacrilatoou com o CPC, que são partículas de fosfato de cálcio cerâmico. Osistema de monitoramento é desenvolvido utilizando um módulo deconversão de dados analógico para digital (4) que apresenta asseguintes características principais:The sensor (2) is bonded to the bone surface (2) with cyanoacrylate or CPC, which are ceramic calcium phosphate particles. The monitoring system is developed using an analog to digital data conversion module (4) which has the following main features:
• Taxa de aquisição: 48 kS/s;• Acquisition rate: 48 kS / s;
• Resolução de entrada: de 10 a 14 bits; e,• Input resolution: from 10 to 14 bits; and,
• Comunicação com PC: USB ou Wireless.• PC communication: USB or Wireless.
O equipamento objeto da invenção realiza o monitoramentoatravés de um sensor (2) epicraniano de deformação, que é umExtensômetro Elétrico de Resistência, também chamado strain-gauge, fixado no osso do crânio na região parietal lateralmente asutura sagital. O equipamento é capaz de detectar, em tempo real, aspequenas variações de dimensões do osso, decorrentes dasalterações de pressão sofridas em seu interior. (Figura 1).The equipment object of the invention monitors through an epicranial strain sensor (2), which is an Electrical Resistance Extensometer, also called strain gauge, fixed to the skull bone in the parietal region laterally the sagittal suture. The equipment is capable of detecting, in real time, the small variations of bone dimensions, resulting from the pressure changes suffered in its interior. (Figure 1).
O invento ora proposto dispõe, também, de um aplicativoespecífico para a monitoração da PIC, possibilitando acompanhar emtempo real um gráfico com as variações da pressão intracraniananuma tela e também o valor instantâneo da PIC numa outra janela,facilitando a leitura por médicos e enfermeiros. A visualização dográfico em tempo real é muito importante, uma vez que muitaspatologias não dependem apenas do valor instantâneo da pressãointracraniana e é relevante acompanhar a curva de suas variações etendências.The proposed invention also has a specific application for ICP monitoring, enabling real-time monitoring of a graph with variations in intracranial pressure on one screen as well as the instantaneous ICP value in another window, making it easier for doctors and nurses to read. Real-time graphical visualization is very important, since many pathologies do not depend only on the instantaneous value of intracranial pressure and it is relevant to follow the curve of their variations and trends.
Dispõe, ainda, de um monitor próprio, que pode ser fixado aolado do leito do paciente e fornecer os valores da pressãointracraniana em tempo real, oferecendo também a opção degravação dos dados em um cartão de memória ou pendrive,facilitando assim a leitura posterior e a analise em qualquercomputador.It also has its own monitor, which can be fixed to the patient's bed and provide the intracranial pressure values in real time, also offering the option of writing data to a memory card or USB stick, thus facilitating later reading and analyze on any computer.
Há também a possibilidade de acoplar o presente inventodiretamente ao registrador de parâmetros médicos comumenteutilizados em hospitais, para isto bastará inserir o cabo do nossoequipamento diretamente no monitor existente no hospital, o que irápermitir ao médico a comparação direta dos dados do nosso sistemacom outros parâmetros clínicos tais como pressão arterial, freqüênciacardíaca, saturações de C02 e 02 e etc.Descrição da Modalidade PreferidaIt is also possible to couple the present inventorirectly to the commonly used medical parameter recorder in hospitals by inserting the cable of our equipment directly into the existing monitor in the hospital, which will allow the physician to directly compare the data of our system with other clinical parameters such as such as blood pressure, heart rate, CO2 and 02 saturation, etc. Description of Preferred Mode
Existem diversos tipos de extensômetros, entretando, para autilização com nosso equipamento foram utilizados inicialmenteextensômetros do tipo Diafragma, em três tamanhos diferentes (5.79mm, 9.25 mm e 11.8 mm). Estes extensômetros trabalham em pontecompleta, geralmente com 350Q, e necessitam dois pares de fiospara serem ligados ao coletor de sinais. Este fato acarreta em umamaior espessura do cabo de conexão e conseguente utilização de umconector de grande calibre, dificultando que o mesmo seja utilizadona passagem por um túnel aberto no couro cabeludo da caixacraniana a ser monitorada.There are several types of strain gauges, however, for use with our equipment were initially used diaphragm-type strain gauges in three different sizes (5.79mm, 9.25mm and 11.8mm). These strain gauges work at full point, usually 350Q, and require two wire pairs to be connected to the signal collector. This fact results in a larger thickness of the connection cable and the consequent use of a large-caliber connector, making it difficult to use it when passing through an open tunnel in the caixacranian scalp to be monitored.
A versão atual do equipamento pode trabalhar comextensômetros de ponte completa, como o descrito acima, ou aindautilizar extensômetros de % de ponte, do tipo SR-4, que possuemapenas um par de fios para serem ligados ao coletor de sinais epodem ser de 120Q, 350Q ou 1000Q. São utilizados nos tamanhosde 2mm, 5mm e 10mm, dependendo do tamanho da caixa craniana aser monitorada. A utilização deste tipo de extensômetro causa umadiminuição na sensibilidade da leitura e pode ser compensada com aadição de um eletrômetro ao modulo de aquisição. O conectorutilizado, neste caso, possui tamanho adequado para passagem domesmo através de um túnel aberto no couro cabeludo da caixacraniana a ser monitorada.The current version of the equipment can work with full bridge strain gauges, as described above, or use SR-4 type bridge bridges, which have only a couple of wires to connect to the signal collector and can be 120Q, 350Q. or 1000Q. They are used in sizes of 2mm, 5mm and 10mm, depending on the size of the skull to be monitored. The use of this type of strain gauge causes a decrease in reading sensitivity and can be compensated by adding an electrometer to the acquisition module. The connector used in this case is of adequate size for passage through the open tunnel through the scalp of the caixacran to be monitored.
Vantagens da invençãoAdvantages of the invention
- O equipamento ora reivindicado apresenta um método capaz demonitorar a PIC de forma minimamente invasiva com segurança,sensibilidade e com custo compatível com os outros procedimentos;- The equipment hereby claimed has a method capable of demonstrating minimally invasive PIC with safety, sensitivity and cost compatible with other procedures;
- O novo sensor epicraniano não perde a calibração, enquanto queos sensores invasivos existentes no mercado perdem a calibraçãoem 5 dias, obrigando uma nova cirurgia e a inserção de um novosensor caso o paciente necessite de um tempo maior demonitoração;- Diminuição considerável do custo do equipamento quandocomparado com os atualmente existentes no mercado;- The new epicranial sensor does not lose calibration, while commercially available invasive sensors lose calibration within 5 days, requiring further surgery and the insertion of a new sensor if the patient needs more time to monitor; compared to those currently on the market;
- Não exige procedimentos cirúrgicos complexos para aimplantação do sensor, e conseqüentemente, não limita suaaplicação aos grandes centros médicos com salas cirúrgicasadequadas e corpo clínico especializado;- It does not require complex surgical procedures for sensor implantation, and consequently, does not limit its application to large medical centers with adequate operating rooms and specialized clinical staff;
- Possibilita o monitoramento em tempo real da pressãointracraniana de forma minimamente invasiva, diminuindo os riscosde infecções e traumas decorrentes do uso do equipamento;- Enables real time monitoring of intracranial pressure in a minimally invasive manner, reducing the risks of infections and trauma resulting from the use of the equipment;
- A simplicidade no implante do sensor permite o uso doequipamento por paramédicos em ambulâncias ou pronto socorros,não necessitando de centros cirúrgicos e neurocirurgiões, o que iráfacilitar e baratear os custos. O valor do novo sistema, que é muitomais barato, o que permitirá ao sistema de saúde público incorporá-loà sua lista de procedimentos;- The simplicity of the sensor implant allows the use of equipment by paramedics in ambulances or emergency rooms, requiring no operating rooms and neurosurgeons, which will facilitate and cheapen the costs. The value of the new system, which is much cheaper, will allow the public health system to incorporate it into its list of procedures;
- O equipamento é capaz de detectar, em tempo real, aspequenas variações de dimensões do osso, decorrentes dasalterações de pressão sofridas em seu interior; e,- The equipment is capable of detecting, in real time, the small variations in bone dimensions, resulting from the pressure changes suffered inside it; and,
- As infecções no sistema nervoso central e o risco de seqüelasdecorrentes dos métodos invasivos são nulas no novo sistema, umavez que não há a exposição do sistema nervoso central ao meioexterno e também não há a inserção de nenhum material no tecidocerebral.- Central nervous system infections and the risk of sequelae due to invasive methods are nil in the new system, as there is no exposure of the central nervous system to the external environment and no material is inserted into the brain tissue.
Descrição das figurasDescription of the figures
A figura 1, ilustra o esquema simplificado do equipamento, ondepode ser observado o crânio do paciente (1), elemento sensor (2),conexão do cabo (3), módulo de aquisição (4), registrador ou plotter(5) e microcomputador para a aquisição, armazenamento eapresentação dos dados (6).A figura 2 ilustra os locais de inserção dos métodos demonitoramento da PIC existentes no mercado, podendo serobservado Sensor intraveicular (7), Intraparenquimatoso (8) eSubracnóide (9).Figure 1 illustrates the simplified scheme of the equipment, where the patient's skull (1), sensor element (2), cable connection (3), acquisition module (4), recorder or plotter (5) and microcomputer can be observed. for data acquisition, storage and presentation (6). Figure 2 illustrates the insertion sites of the ICP monitoring methods available in the market. Intraveicular sensor (7), Intraparenchymal (8) and Subracnoid (9) can be observed.
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