CN100353917C - 受限使用医用探头 - Google Patents

受限使用医用探头 Download PDF

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CN100353917C
CN100353917C CNB008088845A CN00808884A CN100353917C CN 100353917 C CN100353917 C CN 100353917C CN B008088845 A CNB008088845 A CN B008088845A CN 00808884 A CN00808884 A CN 00808884A CN 100353917 C CN100353917 C CN 100353917C
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medical monitoring
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CN1450877A (zh
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D·巴尔
M·T·拉森
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Masimo Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542Measuring 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 blood gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring 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 optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1464Measuring 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 optical sensors, e.g. spectral photometrical oximeters specially adapted for foetal tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0266Operational features for monitoring or limiting apparatus function
    • A61B2560/0276Determining malfunction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08Sensors provided with means for identification, e.g. barcodes or memory chips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006ECG or EEG signals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0008Temperature signals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7232Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves

Abstract

本发明揭示了一种受限使用的医用探头(14)。该医用探头包括一个记忆存储元件(26),用来保存使用值,该使用值代表医用探头(14)的使用次数和/或使用的持续时间。医用探头(14)与保护监测功能(12)的性能的医学监测装置(12)耦连,当使用次数或总的使用时间达到预定的阈值的时候,用它防止探头(14)的使用过度。

Description

受限使用医用探头
发明领域
本发明总的涉及测量临床生理参数(包括生命体征)的医用探测器和方法。更具体地说,本发明涉及一种医用监视系统,这种医用监视系统限制相关探测器装置的使用时间和/或次数,以防止过度使用和出故障。
背景技术
医用探测器装置,如插入患者体内或皮下用以监测生物参数的内窥镜,在本领域中是众所周知的。一般来说,这样的装置有一个罩壳,并且包括至少一个监测元件(如压力探头)、发光器件以及相关的检测器、ECG探头,或其他生命体征监测装置。一例医用探测装置是胎儿探测器,可参见美国专利5,425,362。将胎儿探测器插入母体的子宫壁,对胎儿、母亲以及胎盘进行非侵入式监测。
已知的医用探测装置的问题是,它们都有一定的使用寿命。探测装置经反复使用或者使用了一定时间以后会磨损。使用时间过长会因内部的连线或连接装置松动而产生虚假读数。更重要的是,探测装置会在反复使用或使用了一定时间以后损坏。一旦出现这样的情况,通常很难判断探测器是什么时候出故障的,也很难跟踪故障出现原因。
为了防止出现这些问题,医生会采用设备的使用记录或其他的手工装置,限制某一给定探测装置的使用次数或使用时间。尽管这样做在某些情况下很有效,但对手工记录的依赖性太强,而且费时,很难坚持下去,而且需要数名医生的合作。在医院繁忙特别是在急诊的情况下,这种系统很难管理,容易被忽视。
因此,人们需要有一种医用监测系统,可以自动地限制医用探测装置的使用。这样的一种系统最好能将给定的医用探测装置使用次数或持续使用时间限制在某一要求的限制值上。这种医用监测系统最好能够具有一些附加的功能,如,检错、时间和日期标记,以及保密检查。
因此,本发明的目的是提供一种能够限制医用探测装置的使用次数的医用监测系统。
本发明的又一个目的是提供一种能够限制医用探测装置的使用时间的医用监测系统。
本发明的另一个目的是提供一种具有时间和日期标记功能以识别监测设备进行的监测过程的医用监测系统。
本发明再一个目的是提供一种可以存储关于装置使用时间信息的医用探测器装置。
本发明又一个目的是提供一种可以存储关于装置已经使用的次数的信息的医用监测系统。
本发明再一个目的是提供一种可以给出相关的医用探测装置的产品标识的医用监测系统。
本发明再一个目的是提供一种含有验证所附探测器的标识的保密功能的医用检测系统。
本发明还有一个目的是提供一种包括防止所存储的数据被篡改的保密功能的医用监测系统。
发明概述
本发明的医用探头包括至少一个探测装置以及能够与外部装置交换信息以保存探头使用数据的记忆存储元件。记忆存储元件可以含有医用探头已被使用的次数、每次使用的时间、总使用时间的信息,以及其他有关医用探头使用占空周期的信息。在探测装置的记忆存储区内还可以存储其他的参数,如,某次使用探头的日期和时间、出现某种给定情况的日期和时间、产品的标号、诸如医患数据之类的临床信启、以及其他的医学信息。保密功能最好采用唯一的序号来标识医用探头,从而对装置作出标识,并防止使用数据的篡改。
医用探头与监测装置耦连,形成医用监测系统。监测装置通过与医用探头的信息交换而判断医用探头的使用情况,并将探头的总使用次数限制在某一极限值上,从而防止使用次数超过某一预定的极限。所述的极限值可以是总的使用次数、总的使用时间,或二者的组合。监测装置与医用探头结合在一起,具有验证探测装置标识的保密功能。保密功能最好是根据内设的序号和加密钥来操作,以确保合适的探头与监测系统耦连,确保内部使用数据未被篡改,并验证医用探头和监测装置之间进行的信息交换。
监测系统还可以具有一系列的产品标识功能,以及识别某一给定监测过程中所使用的设备的存储数据。存储数据可以是所使用的设备的序号、日期和时间标记、有关监测过程中所涉及的医务人员的信息、患者数据,以及其他的有关信息。
在本发明的一种最佳实施例中,医用监测系统包含一种胎儿探测器,用以监测胎儿在子宫内时血液中的氧饱和情况。记忆存储元件最好含有一个直接与胎儿探测器连接器耦合的记号计数芯片(token counter chip)。记号计数芯片最好有一个记忆存储器、可以存储使用值的计数器,以及内置的保密功能以防止篡改。
读者在参照附图阅读了本发明的详细描述以后,将会更加明了本发明的组成以及操作方式、优点和特征。图中,相同的标号所表示的元件意义相同。
附图简述
图1是按照本发明一种实施例构成的医用监测系统方框图。
图2是按照本发明一种实施例构成的医用监测系统的操作框图。
图3是按照本发明一种实施例构成的胎儿探测监测仪。
图4是按照本发明构成的医用监测系统的简图。
图5是图4所示连接器的简化内部视简图。
图6是图1所示医用探头一种较佳元件的框图。
图7是图1所示记忆存储元件一种实施例的简化等角图。
图8是图7中沿8-8线的截面图。
较佳实施例的详细描述
下面参看附图,并特别参看图1,图中,在标记10处,示出按照本发明一种较佳实施例构成的医用监测系统方框图。通常,医用监测系统10包含监测装置12和医用探头14。
检测装置12最好有一个控制器16、至少一个记忆存储元件18和显示屏20。控制器16包括一个与外部装置通过串行或其他类型的数字通信进行信息交换的通信端口19。但是,在某些应用场合下,也可以采用其他类型的通信装置。控制器16最好是一个微处理器,但也可以包含一个微控制器或其他类型的控制装置。另外,尽管图中示出的存储元件18含有RAM(随机存取存储器)22和EPROM(电可编程只读存储器)24,但在不偏离本发明的情况下,也可以采用其他已知类型的存储装置。检测装置最好包括有不可擦存储元件,用以存储序号,这将在下文中详述。在某些应用场合下,控制器16可以含有一个板上存储元件18,使得无需采用外部存储装置。
应用探头14通常有一个传感器24,和记忆存储元件26。传感器24可以含有任何数量的探测装置,包括压力探头、ECG探头、EEG探头、温度探头、氧气探头、超声传感器、化学剂探头,或者如图所示,包括发光器件28、30及相关的检测器32。对探测装置24及有关医用监测系统12中所使用的硬件的选择仅取决于要进行的医学监测的种类,而与本发明无关。记忆存储元件26可以含有几个不同的已知装置,如,微控制器或微处理器、EPROM、EEPROM(电可擦可编程只读存储器)或专用芯片。这些装置具有保存涉及医用探头14所使用的数据的存储区。具有存储元件26还具有某些通信能力,如,串行通信端27,或其他的数字通信装置。在某些应用场合下,还可以含有另外的通信装置。最好还具有其他先进的装置,用以提供如产品标号、保密检查以及所用的日期和时间标记功能。在本发明的一种较佳实施例中,记忆存储元件含有有关记号卡芯片,它既具有存储功能,也具有保密功能。其他的较佳装置包括具有内置CRC和序号功能的EEPROM。这些较佳装置将在下文中作更详细的描述。
如上所述,记忆存储元件26的一个重要功能是提供保护有关医用探头14的使用持续时间的数据,和/或医用探头14的使用次数历史资料的存储区。这些数据将在下文中称之为使用值。该记忆存储元件还可以存储诸如序号、产品标号和加密钥的保密信息;诸如监测过程中所包含的日期和时间标记数据、医务人员标识和患者资料的错误跟踪数据;以及其他类型的数据。在另一些实施例中,记忆存储元件26还可以用作存储检错程序的结果和其他测试数据。监测装置12的记忆存储元件18最好还包括保密信息,如,标识监测装置的序号和加密密钥,这些信息可以用来验证通信,以及识别装置。这些将在下文中详述。为保密起见,最好将这些信息存储在不可擦存储元件(图中未示出)中。记忆存储器18最好还存储故障跟踪和校准信息,提供对医用探测器14中存储的信息进行交叉检验。
在一开始进行设定的时候,将代表某一计数或持续时间的初始使用值写入到记忆存储元件26内。还可以将一个或多个加密密钥存储到记忆存储元件26内。序号最好用来标识特定的医用探头14,以及探头的类型。最好将序号和加密密钥存储在检测装置12的存储元件18内。如上所述,这种类型的信息最好存储在不可擦存储区内。序号和加密钥可以用来提供保密功能,这将下文中描述。
下面参照图2,图中示出医用监测系统10一种实施例的操作框图。为了确保恰当的连接并验证已将合适的医用探头14与监测装置12耦连了起来,可以向医用探头14传送一个起始询问信号。在将这样的询问信号传送到探头14以后,监测装置12会在执行下一步动作之前等待来自探头14的确认信号。询问和确认序列40验证记忆存储元件26正在接收的功率,并通过串行或其他类型的通信链路,与监测装置12中的控制器16交换信息。如果没有接收到确认信号,那么医用装置12中的控制器16会判断,医用探头14目前没有与正确的装置连在一起,或者不起作用。控制器最好向显示屏20提供消息,并终止监测功能,直到连接了合适的探头14为止(步骤41)。尽管图中示出了询问和确认步骤,但本领域中的普通技术人员能够理解,这一步骤并不是必须的。另外,执行这一步骤的能力将取决于选择用作医用探头14中记忆存储元件26的元件的功能。
为了确保将合适的医用探头14与监测装置12连接了起来、确保装置之间的通信,并防止篡改记忆存储元件26中存储的使用值,本发明的医用监测系统10最好采用上述序号和加密密钥以提供加密功能42。最好加密每一个序号,并且串行地将它们发送到其他的装置(即,从探头14发送到监测装置,以及从监测装置12发送到探头14),包括数字密钥和对所传送的数据进行的解密的算法。加密可以由已知的系统来提供,如循环冗余检验和、或公共密钥加密系统,它们不仅用来进行验证发送和验证数据,而且还用来确定所发送的数据的特征从而识别特定的发送装置。监测装置12最好在建立起监测装置12的标识之前是不能访问记忆存储元件26中存储的使用值的。如果保密功能无法验证探头14的标识,那么在装上新的医用探头14之前,最好在监测装置12的显示屏20上写上一条消息,并且监测装置12的控制器16停止监测功能(步骤43)。保密功能最好还验证存储元件26的内容没有受到以前的进程所篡改。
在完成了保密检验以后,如序号所定义的那样,最好将医用探头14的标识存储在监测系统12的存储器18内,用于标识。正如将在下文中作更进一步描述(步骤44)的那样,监测装置12的序号还可以被存储在记忆存储元件26内,用于交叉检验。监测系统12还可以采用序号和其他的标识信息,来判断正被使用的探头类型。例如,监测系统12可以判断,所装上的探头14是胎儿监测探头,还是手指探头,或者是成人通常更经常使用的探测装置。使用这些信息,监测系统12可以调节监测参数和算法,以满足特定的监测要求。
一旦验证了存储探头14的记忆存储元件26的标识和内容以后,监测装置12从记忆存储元件26中读出使用值(步骤46),并且最好将该值存储到监测装置12的内存18内。随后,可以将该使用值与代表探头使用极限的存储阈值按照计数或持续时间比较,以验证与探头14相关的使用值没有达到极限(步骤48)。如果使用值大体等于阈值,则最好在显示屏20上写上需要新探头的消息,并且在将合适的探头连接到监测装置12之前,停止监测(步骤50)。在某些实施例中,使用值是通过控制器16写到显示屏20上的,以提醒医务人员医用探头14的剩下的使用情况(步骤52)。如果剩下的使用时间或次数有限,那么就可以使用该信息来判断,是替换探头14呢,还是继续这一过程。在其他的实施例中,在采用探头14以前,可以执行检错程序,启动探头14的每一个传感器24,以验证合适的输出。可以将测试结果存储在探头14中记忆存储装置26的内存内,写到监测装置12的存储器18内,写到显示屏20上,供医务人员直接观看,或者将这些功能相组合。在某些应用场合,如果记忆存储元件26是一个微控制器,或者具有更先进数学能力的其他装置,则可以将使用值保存在记忆存储元件26内,供内部更新。
可以将监测装置12通常用来开始某一监测序列的信号用作开始改变使用值的信号(步骤54和56)。例如,合适信号是,读取一启动的按键或其他的开关装置、从某一外部装置读取输入信号,或者在某些应用中,将探头14与监测装置12相连。如果使用值是代表总使用次数的一个计数值,那么,对于每一监测序列,仅必须改变使用值一次。在这种类型的使用情况下,当使用值达到预定的使用次数的时候,最好将一条消息写到监测装置12的显示屏20上。最好在最后一次使用之前,由控制器16在显示屏20上写上一条警示语,使得医务人员能够得到新的探头用作替换。在某些应用场合下,可以将一连续计数值保存在监测装置12的显示屏20上。一旦使用值已经达到了该阈值,监测装置12中的控制器16将在替换了探头14(步骤60)之前,阻止进行其他的监测序列(步骤58)。尽管在上文中已经描述了从初始使用号改变使用值,但本领域中的普通技术人员将会理解,系统10还可以改变成递增的、递减的、或者使用随机的序列。
在所监视的是持续时间的情况下,在监测序列开始的时候,必须启动一个定时功能。定时功能最好由监测装置12中的控制器16来执行,但如果是在记忆存储装置26是微控制器或其他能够提供时序函数的装置的应用场合,定时功能可以在探头14中进行。当医用探头14的使用时间大体相当于某一预定值的时候,最好将信号发送到监测装置12的显示屏,警示已达到该极限值。该信号可以包含一条写到字母数字显示屏上的消息。显示屏20也可以包含一排指示灯或发光二极管,给出使用和差错信息。在达到使用极限的情况下,医用探头14最好继续工作,直到完成监测序列为止。但是,在开始另一个监测序列之前,监测装置12会读取使用值,并且不允许另一个监测序列开始,直到替换了医用探头14为止。再有,定时功能可以上行计数到已知值,或从初始值下行计数到零。
当监测信号被丢失的时候,或者接收到停止监测信号的时候,(步骤62)最好将日期和时间标记与探头14的标识信息一起存储在监测装置的存储器18内,并与临床记录一起用来跟踪设备的标识和给定监测过程中所涉及的人员。在某些应用场合下,监测装置12可以包括输入装置,如键盘、串行链路和其他的通信装置,用以记录某一过程中所涉及的医务人员和患者的标识,从而给出完整的记录用于以后查阅。在一种较佳实施例中,可以将RFS标识功能组合在监测装置12内,用以识别医务人员、患者和其他的信息。最好将监测装置的日期和时间标记以及其他的标识信息存储在探头14的记忆存储元件26以及监测装置12的存储器18内用作交叉检验。将该信息存储在两个存储区内简化了在出现故障时对给定监测过程中所使用的设备以后的识别过程。在某些应用场合下,可以存储给定过程中所遇到的有关参数的详细信息。尽管在上文中描述了在监测序列结束时存储日期和时间标记信息,但本领域中的普通技术人员将会理解,该步骤也可以是在监测序列的开始时、在出现预定的情况以后、在出现一系列故障的时候、定期地进行,也可以是在出现其他情况的时候进行。
尽管上文中示出了不同的功能框图,本领域中的普通技术人员能够理解,在不偏离本发明的情况下,某些功能的次序是可以改变的,还可以改变某些功能,和作某些添加。
与现有技术医用监测装置有关的问题在胎儿监测装置中特别尖锐。因此,在本发明的较佳实施例中,医用探头14包含胎儿传感器装置80,如图3所示。该装置的更完整的描述见美国专利5,425,362(已通过引用加入于此)。胎儿传感器装置80(下文中称之为“装置80”)包括罩壳82,和带有软模压成形末梢86的柔性尾端部分84。尾端部分84最好与装置80的其余部分整体总装在一起。活动尾端部分84和软模压成形末梢86有助于使薄膜损坏的可能性为最小。如图3所示,装置80包括一个柔性带88(如涂覆有光滑表面90的弹簧马(spring steed))(如硅橡胶或特福龙)。
装置80最好包括一个或多个不同的探测器,如压力探测器100、ECG探测器102、EEG探测器104、温度探测器106、氧探测器108、超声传感器/探测器110、用相关的探测器114发射IR信号的激光二极管112,以及化学探测器116。在某些应用场合下,压力探测器100可以包括一个气球型的装置118,它可以膨胀至各种不同的压力,并采用传统的反馈电子线路,使至少一个胎儿或母亲的子宫与装置100的结合保持在常压下。
在一种较佳实施例下,装置80采用前文中描述的各种探测器,来测量胎儿心率(ECG探测器102)、胎儿血液中的氧饱和度(通常包含一个或多个发光二极管和相关的检测器(未示出)的氧探测器108),以及胎儿随子宫温度的差异(温度探测器130),使得能够对胎儿的健康评估作出三种判决的树形分析(three-prongeddecision tree analysis)。如果出现子宫-胎盘-胎儿不足,通常会因良好充满(well-perfused)的胎盘136热交换产生的胎儿热丢失而使胎儿温度上升。血氧特征研究可以在临床上,在不明显的边缘心率值和显著的胎儿不良应激之间作出鉴别。还可以在出现胎儿胎儿不良应激的时候,累计ECG数据,确认是否进行分娩。尽管图中示出了监测几种医学参数的胎儿探测器80,但本领域中的普通技术人员能够理解,根据所要求的应用场合的不同,可以采用将探测器组合起来的方式。在某些较佳实施例中,装置80可以包含一个血氧计传感器,它包括两个或更多的具有不同波长的发光二极管和相应的检测器。光的反射和吸收用来以已知的方式计算充氧水平。本应用中,监测装置12包含一个计算充氧水平的血氧计。
再参见图3,所有探测器均取道与一个电连接点120的连接。在一种较佳实施例中,连接点120包含将适配连接器124与监测装置12耦连的连接器122(图4和图5)。记忆存储元件26最好直接与连接器122耦连,以限制医用探头的整体尺寸。胎儿探测器80的电能最好由监测装置12来提供。
如上所述,在一种最佳实施例中,采用记号卡,作为记忆存储元件26。一种合适的装置是由Microchip Technology Inc制造的KeeloqTMToken Card Chip(记号卡芯片)SCS 152。与SCS 152相关的数据表(Data Sheets)由MicrochipTechnology Inc在1997年公开。现在参见图6,相关的数据表所重现的框图示于标记130处。记号卡芯片给出保存记号计数值的记忆存储器132、其他未定义的记忆存储器、特征计算器134、串行输入/输出端136、控制器138,以及含有两个输入的命令接口140。特征计算器含有内置保密功能,使得无需另外提供加密软件。计数值在装置中初始化,给出当前应用的使用值。所描述的记号卡芯片需要有一个外部信号来改变计数值,但是,自动变更计数值的类似装置也可供使用。控制接口140和串行输入/输出端136可以与如前述的控制器16的外部控制器、串行接口装置和其他的已知元件耦合,以给出记忆存储器和上述使用值信息。
记号计数芯片的一个优点是对功率要求很低,并且可以直接由连接到传统系统中的发光器件的供电线路供电。将芯片与这些电源线相连无需添加其他的连线,并防止了移去对计数装置的供电的电源而引起的数据篡改。
最好记号卡芯片以及其他适合本应用的器件能够较小,而能够装在连接器122的后背上。记号卡芯片最好能够以通常已知的“盖板上的芯片”的方式来构成。(图7和图8)这种类型的芯片含有一个玻璃层或陶瓷层119、半导体层121,以及沿半导体层的侧面延伸的多个表面安装型连接器123。芯片因此较小,并可以方便地滑到连接器上,并焊接在所需的位置上,从而使探头14的尺寸为最小。在将芯片焊到连接器120上以后,最好在芯片上敷设涂覆层125,以防止与相邻连接元件的无意接触。该层可以包含液带(liquid tape),或者任何一种公知的材料。
当探头14被构成为包括记号卡芯片时,监测装置12中包括合适的硬件和与记号卡芯片接口的软件。该系统更详细的描述的操作见美国专利5,841,866。但是,通常接口设备必须具有完成保密的功能(包括加密和解密保密通信所需的密钥)以及使记号计数值递减的能力。
在另一种较佳实施例中,记忆存储元件26包含一个由Dallas Semiconductor生产的EEPROM,其部件号为DS2430A。该元件的数据表由Dallas Semiconductor公开,在此引述供参考。
EEPROM是一种小型的低电源供电的芯片,仅包括三根引线:电源线、接地线和串行通信管脚。唯一的序号在制造过程中烧结在每一器件内,因而很容易识别。该存储器还包括一个CRC,以验证数据内容。因此,该器件具有许多的保密优点。
与上述的记号卡芯片一样,该器件直接与连接器20耦连,而使得与探头14的连接尺寸和复杂性为最小。记忆存储元件26与监测装置12之间的通信是通过一个通信管脚来传送的,因而连接简单,连线减少。
尽管上文中已经描述了本发明的较佳实施例,但应当理解,在不偏离本发明的精神的情况下,还可以有各种变化和修改形式。本发明的各种特征由权利要求书所限定。

Claims (15)

1.一种医用监测系统,其特征在于,它包含:
医用探头,它包括至少一个传感器、一个记忆存储元件、一个通信端口以及一个探头连接器,其中,所述记忆存储元件包括限制所述医用探头的使用的使用值、标识所述医用探头的序号和至少一个加密密钥;以及
监测装置,它包括监测器连接器、控制器、存储标识所述监测装置的序号和至少一个加密密钥的记忆存储装置,以及通信端口,其中,所述监测装置将所述医用探头的使用限制在预定的阈值上。
2.如权利要求1所述的医用监测系统,其特征在于,所述医用探头是一个胎儿传感器。
3.如权利要求1所述的医用监测系统,其特征在于,它还包含与所述监测装置耦连的显示器。
4.一种验证医用监测系统元件的标识以防止存储数据被篡改的方法,包含以下步骤:
在医用探头的记忆存储元件中存储医用探头序号、加密密钥以及至少一个医用监测参数;
在医用监测装置的记忆存储元件中存储医用监测装置序号和加密密钥;
将所述医用探头与所述医用监测装置耦连;
加密所述医用探头中存储的所述序号、将所述经加密的序号发送到所述医用监测装置,并解密所述医用监测装置中的序号;
通过所述经解密的数据验证所述医用监测装置的所述标识;
如果验证了所述医用监测装置的所述标识,则使所述医用监测装置能够访问所述医用监测参数;
如果未验证所述监测装置的所述标识,则阻止所述医用监测装置访问所述医用监测参数。
5.如权利要求4所述的方法,其特征在于,所述医用监测参数是一个使用值。
6.如权利要求4所述的方法,其特征在于,它还包含将所述医用监测参数存储到一个不可擦记忆存储元件内以防擦除的步骤。
7.如权利要求6所述的方法,其特征在于,所述存储元件是EPROM。
8.如权利要求4所述的方法,其特征在于,所述医学监测参数包括使用值和阈值。
9.一种保存医用探头使用历史记录的方法,其特征在于,所述方法包含下述步骤:
将标识所述医用探头的序号存储在所述医用探头的存储元件内;
将日期和时戳存储在所述医用探头的所述存储元件内;
存储与某一过程相关的医务人员的标识,并将所述医务人员的所述标识存储在所述医用探头的所述存储元件内;
将患者资料存储在所述医用探头内;以及
检索所述存储的信息,以提供某一医学过程的历史记录。
10.如权利要求9所述的方法,其特征在于,它还包含这样一些步骤,即,将所述医用探头与一医用监测装置耦连,将所述医用监测装置的所述序号存储在所述医用探头的存储元件内,并将标识所述医用探头的序号存储在所述医用监测装置内。
11.如权利要求10所述的方法,其特征在于,它还包含将所述日期和时戳存储在所述医用监测装置内的步骤。
12.如权利要求10所述的方法,其特征在于,它还包含将所述医务人员的所述标识存储在所述医用监测装置内的步骤。
13.如权利要求10所述的方法,其特征在于,它还包含将所述患者资料存储在所述医用监测装置内的步骤。
14.如权利要求10所述的方法,其特征在于,它还包含这样一个步骤,即,交错检查所述医用监测装置和所述医用探头之间的数据,还包含这样一些步骤,即,将所述医务人员的标识存储在所述医用监测装置内以及/或者将患者资料存储在所述医用监测装置内、将所述医用探头与所述医用监测装置之间的耦合断开、把所述医用探头或另一医用探头与所述医用监测装置重新耦合起来、将所述医务人员的标识和/或所述患者资料和/或标识重新耦合的医用探头的序号从所述重新耦合的医用探头发送到所述医用监测装置,并将其与所述医用监测装置中存储的相比较。
15.如权利要求10所述的方法,其特征在于,它还包含这样一个步骤,即,加密所述医用监测装置的至少一个序号和所述医用探头的序号,以防被篡改。
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US6308089B1 (en) 2001-10-23
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