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前言導(dǎo)讀

心力衰竭（heart failure）簡稱心衰，是指由于心臟的收縮功能和（或）舒張功能發(fā)生障礙，不能將靜脈回心血量充分排出心臟，導(dǎo)致靜脈系統(tǒng)血液淤積，動脈系統(tǒng)血液灌注不足，從而引起心臟循環(huán)障礙癥候群，此種障礙癥候群集中表現(xiàn)為肺淤血、腔靜脈淤血。心力衰竭并不是一個獨(dú)立的疾病，而是心臟疾病發(fā)展的終末階段。

據(jù)不完全統(tǒng)計，2018年我國已有1000萬心衰患者，2019年全球心力衰竭患病人數(shù)達(dá)2970萬，預(yù)計2030年將進(jìn)一步增加到3870萬，即2024年至2030年的復(fù)合年增長率為2.5%。

心衰是多種原因?qū)е滦呐K結(jié)構(gòu)和/或功能的異常改變，使心室收縮和/或舒張功能發(fā)生障礙，從而引起的一組復(fù)雜臨床綜合征，關(guān)于心衰的原理，筆者通過如下央視的權(quán)威介紹向讀者進(jìn)行闡述：

心衰醫(yī)療器械

目前，藥物是治療心力衰竭的第一大手段。針對心力衰竭的原因，每種藥物的目的是不同的，有些用于緩解心力衰竭癥狀，而另一些用于減緩心力衰竭的進(jìn)展并防止并發(fā)癥。然而，有時僅靠藥物不足以減緩心力衰竭，需要額外的治療。

用于心力衰竭的醫(yī)療器械設(shè)備分為兩大類：診斷和治療。診斷設(shè)備用于監(jiān)測心力衰竭，可以跟蹤惡化的跡象，并且通常可以在發(fā)現(xiàn)癥狀之前發(fā)現(xiàn)問題。

雅培（Abbott ）的CARDIOMEMS HF是目前最知名的心衰診斷設(shè)備，本篇文章筆者以CARDIOMEMS為例，對心衰診斷醫(yī)療器械進(jìn)行闡述。

認(rèn)識CARDIOMEMS

CardioMEMS是一種使用微機(jī)電系統(tǒng)(MEMS)技術(shù)的無線壓力敏感器件。該設(shè)備由植入式高頻傳感器、輸送導(dǎo)管和電子監(jiān)測單元組成。采用右心導(dǎo)管插入術(shù)(RHC)和局部麻醉，將裝置植入遠(yuǎn)端肺動脈。它由一個線圈和一個電容組成，電容由硅膠覆蓋的密封硅膠外殼包裹，形成一個能在特定頻率下諧振的電路。施加在傳感器上的PAP變化會導(dǎo)致諧振波的頻率變化。該設(shè)備通過其氣壓計檢測到的周圍大氣壓力變化來測量肺動脈壓力。CardioMEMS不含任何電池或?qū)Ь€，由外部天線以射頻信號的形式供電。

CardioMEMS示意圖

患者在家里時，通過使用便攜式電子設(shè)備和包含天線的特殊枕頭，收集的信息被轉(zhuǎn)換成壓力測量值，并傳輸?shù)桨踩姆?wù)器進(jìn)行處理。當(dāng)天線靠在身體上或患者躺在枕頭上時，讀數(shù)就會出現(xiàn)。這個過程是無痛的，在閱讀過程中不會產(chǎn)生任何異常感覺。電子單元每天傳輸功率放大器測量值。醫(yī)生可利用這些數(shù)據(jù)在充血性癥狀出現(xiàn)之前調(diào)整HF治療(主要是通過調(diào)整利尿劑劑量)，最終降低住院率。

系統(tǒng)示意圖

臨床試驗(yàn)數(shù)據(jù)證明，CardioMEMS HF系統(tǒng)可降低心力衰竭住院率和死亡率，并改善HFrEF和HFpEF患者的QOL效應(yīng)。由CardioMEMS HF系統(tǒng)提供的癥狀前數(shù)據(jù)允許在心力衰竭癥狀出現(xiàn)之前對藥物治療進(jìn)行前瞻性改變。能夠單獨(dú)設(shè)置患者閾值，使醫(yī)生能夠個性化和優(yōu)化每位患者的護(hù)理和醫(yī)療管理。

CardioMEMS HF在2014年首次獲得FDA批準(zhǔn)且證明可明顯減少住院治療的心衰監(jiān)控設(shè)備，但是當(dāng)時只適用于測量NYHA（紐約心臟協(xié)會）標(biāo)準(zhǔn)下，III級心衰患者的心率和肺動脈壓。近日，雅培宣布FDA批準(zhǔn)擴(kuò)大CardioMEMS HF的適應(yīng)癥---可用于 II 級心衰患者和接受血液檢查顯示為利鈉肽的生物標(biāo)志物水平升高的患者。

筆者注：HFrEF為射血分?jǐn)?shù)降低的心力衰竭，HFmrEF為射血分?jǐn)?shù)中間值的心力衰竭，HFpEF為射血分?jǐn)?shù)保留的心力衰竭，LVEF為左心室射血分?jǐn)?shù)；利鈉肽升高為B型利鈉肽（BNP）>35 ng/L和/或N末端B型利鈉肽原（NT-proBNP）>125 ng/L。

來源：《中國心力衰竭診斷和治療指南2018》

專利分析

需要說明的是，本文著重對心衰診斷設(shè)備進(jìn)行闡述，對于CardioMEMS醫(yī)療器械相關(guān)專利，筆者進(jìn)行了詳細(xì)研讀和分析，形成了卓有成效的工作成果，基于篇幅原因，本篇文章筆者著重從通訊和傳感器兩個方面進(jìn)行簡要闡述，同時，對于ICD、CRT、VAD等心衰治療器械，筆者也完成了相關(guān)研究，如若獲取完整專利清單與分析報告可以與筆者取得聯(lián)系，共同交流學(xué)習(xí)。

1

公開/公告號	US7839153B2	申請日	2009-05-15
發(fā)明名稱	Communicating with an implanted wireless sensor
解決的技術(shù)問題	The resonant frequency of the sensor is a measured parameter that is correlated with the physical parameter of interest. To be clinically useful there must be means to ensure that variations in measurement environment do not affect the accuracy of the sensor. Thus, there is a need for a system and method for communicating with a wireless sensor that considers variations in the measurement environment.
技術(shù)方案	The present invention determines the resonant frequency of a sensor by adjusting the phase and frequency of an energizing signal until the frequency of the energizing signal matches the resonant frequency of the sensor. The system energizes the sensor with a low duty cycle, gated burst of RF energy having a predetermined frequency or set of frequencies and a predetermined amplitude. The energizing signal is coupled to the sensor via magnetic coupling and induces a current in the sensor which oscillates at the resonant frequency of the sensor. The system receives the ring down response of the sensor via magnetic coupling and determines the resonant frequency of the sensor, which is used to calculate the measured physical parameter. The system uses a pair of phase locked loops to adjust the phase and the frequency of the energizing signal.
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2

公開/公告號	US6278379B1	申請日	1999-12-06
發(fā)明名稱	System, method, and sensors for sensing physical properties
解決的技術(shù)問題	Sensing technology is currently employed in a number of different environments. Specifically, sensors employed to determine the pressure or temperature of a medium are used in a wide variety of applications. Most such applications involve the use of temperature and pressure sensors in environments of low temperature or in environments of high temperature which require adequate cooling measures or the use of high temperature materials in the construction of such sensors. In such applications, for example, micro-machining techniques exist by which pressure sensors are constructed using silicon as a substrate.
技術(shù)方案	Several sensors are provided for determining one of a number of physical roperties including pressure, temperature, chemical species, and other physical conditions. In general, the sensors feature a resonant circuit with an inductor coil which is electromagnetically coupled to a transmitting antenna. When an excitation signal is applied to the antenna, a current is induced in the sensor circuit. This current oscillates at the resonant frequency of the sensor circuit. The resonant frequency and bandwidth of the sensor circuit is determined using an impedance analyzer, a transmitting and receiving antenna system, or a chirp interrogation system. The resonant frequency may further be determined using a simple analog circuit with a transmitter. The sensors are constructed so that either the resonant frequency or bandwidth of the sensor circuit, or both, are made to depend upon the physical properties such as pressure, temperature, presence of a chemical species, or other condition of a specific environment. The physical properties are calculated from the resonant frequency and bandwidth determined.
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