CN101534883A - 注射设备和方法 - Google Patents

注射设备和方法 Download PDF

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CN101534883A
CN101534883A CNA2007800407139A CN200780040713A CN101534883A CN 101534883 A CN101534883 A CN 101534883A CN A2007800407139 A CNA2007800407139 A CN A2007800407139A CN 200780040713 A CN200780040713 A CN 200780040713A CN 101534883 A CN101534883 A CN 101534883A
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armarium
user
armarium according
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injection
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克里斯托弗·V·雷贾尔多
纳穆瓦尔·基亚叶
詹姆斯·汤姆森
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Therasense Inc
Abbott Diabetes Care Inc
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Abstract

本发明提供了具有受限制的访问的医疗设备及其方法。

Description

注射设备和方法
相关申请的交叉参考
本申请要求于2006年10月31日提交的题为“注射设备和方法”的美国专利申请序列第11/555,207号的优先权，其全部内容通过引证结合在此。
背景技术
多种医疗设备用于监测健康状况。例如，这些设备包括那些被设计用来使用户能够至少部分地基于体内分析物的水平来管理健康状况的设备。这种类型的设备包括分析物确定设备、药物传送设备等等。
这种分析物设备在近几年已经广泛应用于糖尿病病人。糖尿病患者通常通过刺破指尖或其他身体位置(即，备选地点)进行滴血、将血涂至手持测试仪中的一次性测试条上并使测试仪和测试条对血液执行电化学检测，以确定当前的血糖浓度，从而测得患者的血糖水平。这种离散的或个别的体外检测每天通常要操作多次。美国专利第7,058,437号(于2006年7月6日授予TheraSence公司)提供了这种血糖监测系统及其使用的详细说明，其全部内容通过引证结合在此。
体内葡萄糖监测设备被设计用于提供连续的葡萄糖监测。某些这种连续系统使用插入皮肤的一次性经皮传感器(transcutaneoussensor)来测量间质流体(interstitial fluid)中的血糖浓度。传感器的一部分从皮肤突出并与耐用的控制器和发送器单元相耦合，该控制器和发送器单元通过粘合剂与皮肤相连。无线的手持单元与安装在皮肤上的发送器和传感器相结合进行使用，以周期性地(诸如一分钟一次)接收血糖信息。在预定的时间间隔(诸如每三天、五天或七天)内，一次性传感器被移除并替换为新传感器，所述新传感器再次耦合至可重复使用的控制器和发送器单元。利用这种安排，糖尿病患者可以使用手持单元连续地监测他们的葡萄糖水平。体内系统中的手持单元还可以包括用于执行如上所述的个别检测的体外测试条测试仪。体外测试条测试仪可以用于在每次有新的体内传感器植入时校准连续监测系统。此外，当体内系统出现故障、新传感器达到平衡(equilibrate)、或者当发送器必须关闭时(诸如，在班机起飞和降落期间)，体外测试条测试仪可以用作备份。美国专利第6,175,752号提供了这种连续的葡萄糖监测系统及其使用的详细说明，其全部内容通过引证结合在此。
药物传送设备是使能了对用户的可控用药的设备，其包括完全可植入注射泵以及通过诸如挠性管路的经皮放置的流道(fluidchannel)注入药物的泵。泵可以在健康监测设备的控制或半控制下，或者可以由用户控制。这种实例包括由糖尿病患者使用的胰岛素泵，从而使用胰岛素来控制血糖。
体外或体内葡萄糖监测、以及胰岛素传送设备的目的是帮助糖尿病患者将他们的血糖保持在预定范围内。如果人的血糖水平升得太高，就会出现高血糖症。高血糖症的短期效果可以包括疲惫、认知能力缺失(loss of cognitive ability)、情绪不稳定、过量排尿、过度口渴以及过度饥饿。而更为紧急的是，如果人的血糖水平降得太低，就会出现低血糖症。与高血糖症相似，低血糖症的症状也包括疲惫和认知能力缺失。但是，如果不进行检查，低血糖症会很快导致失去知觉或昏迷。一些糖尿病患者有较少或者没有低血糖的症状，或者发现很难区分高血糖症状和低血糖症状。没有将血糖水平保持在适当范围内的长期效果包括健康并发症，诸如心血管疾病、慢性肾衰竭、可以导致失明的视网膜损伤、神经损伤、阳痿、以及具有截除脚趾、脚、甚至腿的风险的软组织坏死。很明显，适当的葡萄糖监测以及基于监测的正确行为对于糖尿病患者保持其健康而言是十分重要的。
同样重要的是葡萄糖监测状态的适应性。对于需要监督的人(例如，小孩子或智力损伤的人)来说适应性尤其难。适应性可以包括严格坚持健康护理提供者和/或护理提供者的命令。如果健康护理指令改变，用户有必要及时获知这些改变。同样，当人需要被提醒时指令可以轻易得到，这也是很重要的。
发明内容
在概述本发明之前，应理解，本发明适用于体外分析物监测设备、体内分析物监测设备、以及药物注射设备。除非另外指出，本文仅具体参照这种设备中的一个设备，只是为了简洁而不是为了限制本发明的范围。此外，本发明主要是相对于葡萄糖监测设备和胰岛素注射泵来进行描述的，其中，这种描述不是为了显示本发明的范围。应理解，本发明适用于任何适合的分析物监测设备和药物注射设备。
根据本发明的一些实施例方面，医疗设备(体外分析物监测设备、体内分析物监测设备、药物注射设备)配置有警报部件。这些警报部件协助用户保持适当的分析物水平。血糖是可以使用本发明的方面来保持的很多分析物中的一个。对于每个用户，可以建立理想或目标分析物范围。在这个理想范围之上或之下，还可以分别建立适度关注的较高范围和较低范围。在适度关注的较高范围以上，可以建立高度关注的较高范围。类似地，在适度关注的较低范围以下，还可以建立高度关注的较低范围。通过实例，用户可以使用(诸如)手持测试仪和测试条进行体外血糖测量。在本发明的一些实施例中，当测量落入适度关注的较高范围或较低范围中时，测试仪可以向用户发出警报。警报可以向用户表示测量结果落入了适度关注的较高范围和较低范围中的哪一个。
根据本发明的另外一些方面，医疗设备(体外分析物监测设备、体内分析物监测设备、药物注射设备)配置有警告部件。这些警告部件协助用户保持适当的分析物(例如，血糖)水平。如上所述，可以建立高度关注的较高血糖范围和较低血糖范围。在本发明的一些实施例中，当测量落入高度关注的较高范围或较低范围中时，测试仪可以提供警告，从而警告用户。优选地，该警告可以向用户表示测量结果落入了高度关注的较高范围和较低范围中的哪一个。此外，优选地，警告表示比前述警报更高的紧急等级。应注意，在用户进行分析物测量之前用户的分析物等级可以从理想范围经过，通过适度关注的范围并进入高度关注的范围。在这种情况下，用户可以提供有警告，而不首先接收到警报。
根据本发明的其他方面，分析物监测系统配置有提醒部件。该提醒部件还协助用户保持适当的分析物(例如，葡萄糖)水平。如上所述，可以建立适度或高度关注的分析物范围。在本发明的一些实施例中，测试仪可以具有提醒部件，其在测试值落入适度或高度关注的范围内时被触发。提醒信号可以在预定的一段时间之后提示用户，以进行另一次分析物测量，从而确保分析物水平向理想范围接近或返回至理想范围。这种提醒部件会特别有用，因为它解放了用户，使其不再试图记住重新检测的时间或者(如果可以得到)设定外部警告。对于那些需要监管的用户，诸如孩子，提醒部件通过为用户提供重新检测提醒来自动地协助护理者，即使在护理者没有出现以执行提醒的任务时。
根据本发明的多个方面，上述警报、警告和提醒可以在视觉上(诸如，利用图像用户界面(GUI)或发光二极管(LED))传达给用户。在本发明的一个实施例中，固定的一段液晶显示器(LCD)被用作GUI，其中当没有处于理想范围内时，分析物测量的值以闪烁数字形式出现。此外，或者说是在备选的实施例中，当分析物测量结果处于适度和/或高度关注的较高或较低范围内时，可以用向上和向下的箭头图标来显示。例如，当水平处于适度关注的范围内时，可以显示不间断的箭头图标，而当水平处于高度关注的范围内时，可以显示闪烁的箭头。根据水平是否处于适度或高度关注的范围内，可以使用不同的箭头。例如，当分析物水平处于适度关注的范围内时，可以显示具有第一尺寸的箭头图标，而当水平处于高度关注的范围内时，可以显示更大的或垂直放置的箭头图标。备选地，当分析物水平处于理想范围内时，可以显示水平箭头，当水平处于适度关注的较高或较低范围内时，可以分别显示向上或向下倾斜的箭头，而当水平处于高度关注的较高或较低范围时，可以分别显示陡峭地向上或向下倾斜的箭头。备选地，上述箭头的相反方向可以用来指示要采取的行动的过程，而非当前水平是高还是低。例如，高分析物水平可以显示向下指的箭头，以指示用户应当降低他或她的分析物水平。在其他实施例中，诸如+、-以及＝的符号可以用于分别指示较高、较低以及符合预期的读数。可以引入代替固定元件显示器或与其相结合的点阵显示器的使用，从而例如为用于向用户提供警报和/或警告和/或提醒的更大的复杂度做准备。显示器上可以显示文本，具有或不具有随附的图标，以及具有或不具有用户反馈，以将关于特定警报、警告和/或提醒的信息提供给用户。例如，在检测结果落入关注范围内之后，可以出现文本来解释结果的重要性，建议一种或多种动作过程，和/或指示用户应该在某段时间之后重新检测。在这段时间已经过去之后，会出现更多的文本消息，可包括进行进一步检测的指令。可以下载一些文本消息，或相反地，作为规定的部分由健康护理提供者激活。
为减少测量仪的尺寸和成本，一个或多个LED可以用于向用户传达警报、警告或提醒。例如，当分析物测量结果不在理想范围内时，可以点亮单个LED。当处于适度处于适度关注的范围内时，LED可以是不间断地亮，而当处于高度关注的范围内时则闪烁。一个或多个LED的不同的颜色可以表示不同的范围。例如，绿色可以表示分析物水平处于理想范围，黄色可以表示该等级处于适度关注的范围，而红色可以表示该等级处于高度关注的范围。两个LED可以用来表示该值是高还是低(或者用户的分析物水平应该上升还是下降)。可以使用三个LED，例如其中，第一LED表示低于理想范围的分析物水平，第二LED表示处于理想范围的水平，而第三LED表示高于理想范围的水平。四个LED可以用来分别表示分析物水平处于高度关注的较低范围、适度关注的较低范围、适度关注的较高范围以及高度关注的较高范围。第五LED可以加入以表示处于理想范围的水平。
除了警报、警告和提醒的视觉指示器之外，根据本发明的多个方面构造的血糖测量仪可以加入听觉或物理反馈。由于糖尿病会对人的视力造成不利地影响，这种形式的用户界面就变得十分必要了。在本发明的一个实施例中，测量仪可以发出可听到的音调来指示分析物读数处于理想范围之外。高音可以用来指示高于理想范围的读数而低音可以用于指示低于理想范围的读数。脉冲或间歇的音调可以用来表示读数处于高度关注的范围。不同数量的音调和其他变化可以用来指示分析物读数所处的范围。类似地，诸如在手机中使用的振动信号可以以不同变化的方式使用，以向用户指示警报、警告和提醒。
根据本发明的多个方面，在制造期间上述警报、警告和提醒可以设定为缺省的参数，和/或可以由HCP(健康护理专家，诸如医生或持有执照的糖尿病教育者)设定为对应于用户的前述值的水平，和/或可以由用户配置。在本发明的一个实施例中，提供了测量仪，其被设置为自动提醒用户在检测结果落到理想分析物范围之外的预定的时间段之后进行重新检测，而这是可以预先设定或配置的。该测量仪可以用于使用户或健康护理专家能够禁用该部件。在备选实施例中，可以在外部配置测试仪，其中这种提醒部件是被禁用的，但具有允许用户或健康护理专家使能该提醒部件和/或设定配置参数的准备。根据基本的分析物测量是处于适度关注的范围还是高度关注的范围而可以将测量仪配置为允许不同的提醒参数。在一个实施例中，医疗设备在检测结果落入适度关注的范围内之后以第一听觉信号提醒用户重新检测第一时间段(例如，约30分钟)，并在检测及过落入高度关注的范围内之后以第二听觉信号提醒用户重新检测第二时间段(例如，约15分钟)。在某些实施例中，第二听觉信号比第一听觉信号具有更高的音量水平和/或更长的持续时间，且第二时间段可以短于第一时间段。在该实施例中，第二听觉信号还可以伴随有振动信号。在这个或备选的实施例中，当用户未确认(比如按按钮，或者执行实际的检测)时，第一和/或第二信号可以继续或重复。提醒信号的参数还可以根据分析物读数在理想范围之上或之下而不同，和/或可以基于分析物测量的实际值而改变。对于每个提醒(警报或警告)，设定可以包括但不限于分析物值、提醒时间、提醒类型(例如，视觉、听觉、振动、或其组合)、提醒的持续情况(例如，一次、一分钟一次重复n次、或一分钟一次直到确认)、以及持续提醒重复的次数(n)。
根据某些实施例，医疗设备可以配置有警报、警告和提醒设定、或其他可由授权的个人(如监管角色中的个人，如HCP或护理者)进行配置和锁定的健康护理信息。该信息被锁定，直到由诸如授权的个人(例如，HCP或护理者)提供访问码。这种安排避免了在HCP护理下的患者改变规定，或避免了从护理者接受指导的患者(如，孩子)修改配置值。这避免了对配置值的有意或无意的改变。还避免了绕过警报、警告或提醒，诸如当用户想进行可能影响分析物水平的行为(例如，暴食)。根据其他方面，诸如在医疗设备连接至上载和/或下载信息的计算机时，可以通过医疗设备数据端口设置配置设定。在某些实施例中，医疗设备可以被配置以使有限数量的个人(例如，HCP和/或护理者)能够通过数据端口设定和锁定配置值。
本文描述的本发明方面的应用不仅限于血糖监测和/或胰岛素注射。例如，可以在诸如间质流体的其他物质中监测分析物。此外，在样品体液中，监测的分析物除葡萄糖之外，还有诸如乳酸酯、乙酰胆碱、淀粉酶、胆红素、胆固醇、绒膜促性腺激素、肌酸激酶(例如，CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷酰胺、生长激素、血细胞比容、血红蛋白(例如，HbAlc)、激素类、酮类、乳酸盐、氧、过氧化物、前列腺特异抗原、凝血酶原、RNA、促甲状腺激素、和肌钙蛋白。测试仪还可以被设置为确定药品的浓度，所述药品例如是抗生素(例如，庆大霉素、万古霉素等)、毛地黄毒苷、地高辛、滥用的药品(drugs of abuse)、茶碱、华法林等。这样的分析物可在血液、间质流体、唾液、尿液和其他体液中进行监测。还应注意，可以使用本文中描述的较少的或附加的分析物测量范围。这包括完全不使用范围，而是使用例如本领域普通技术人员公知的绝对值、公式、查找表或相似概念，以确定对于特定的分析物测量结果的警报、警告、提醒或其他指示是否应向用户发送，以及指示的类型。
附图说明
每个附图均图示地示出了本发明的各个方面。其中：
图1是示出了根据本发明的方面构造的分析物监测系统(诸如血糖测试仪系统)的示例性实施例的平面图；
图2是胰岛素传送设备的示例性实施例的框图；
图3是示出了与图2的传送设备相结合的胰岛素治疗管理系统的示例性实施例的框图；
图4是多种警报和警告显示的详细实例，其中一个在图1的系统中示出；
图5是示出了用户的葡萄糖水平会随一天当中的一部分的过程是怎样变化的曲线图；
图6是示出了图3中示出的葡萄糖水平的曲线图，其中添加有检测点，其中的某些由于提醒(警报或警告)而发生；
图7A和图7B示出了含受限制的用户控制的医疗设备的示例性实施例；
图8示出了连接至数据管理系统的示例性实施例的图7B的医疗设备；以及
图9示出了可以在图8的数据管理系统上运行的应用软件的示例性实施例。
根据图示的本发明的改变是预期的。
具体实施方式
下面的描述集中在本发明的一个变化上。本发明的变化被视为没有限制的实例。应理解，本发明不限于本文阐述的特定变化并且完全可以改变。在不背离本发明的精神和范围的前提下，可以对描述的本发明进行修改并可以对等效物进行替换(可以是现在已知的，也可以是将来开发的)。此外，可以进行修改以适应特定环境、材料、针对目标的事件、过程、过程动作或步骤的合成、本发明的精神或范围。
图1示出了示例性的分析物医疗系统10(例如，这个特定实施例中的血糖测试仪系统)的顶视图。分析物医疗设备10可以是电化学或光学系统。系统10包括手持测试仪12和一次性测试条14。测试条14可以插入或从测试仪12的测试条端口16移除，从而与其物理连接以及电连接。测试仪12包括用于向测试仪用户显示信息的LCD显示器18、以及用于接收用户输入的按钮20、22和24。
通常，为了使用测试仪12测量血糖，用户将新的测试条14插入测试仪12的端口16。在测试条插入测试器之前或之后，用户会刺破指尖或身体的其他部位(即，备选地点)以向皮肤表面滴一小滴血26。将测试仪和测试条放置在那滴血26上从而使取样容器的一端28接触到那滴血26。虽然这个特定实例教导了侧填充(side-fill)测试条的使用方法，应理解，可以使用端填充(end-fill)、顶填充(top fill)或其他类型的测试条。此外，分析物检测可以完全不需要测试条。例如，某些测试仪会利用旋转测试轮而非单个测试条来进行多种测量。本实例中，表面张力(毛细作用)自动地将少量的血26吸入取样容器，而测试仪12自动执行电化学测试以确定血液26中的血糖浓度。之后，葡萄糖水平30显示在测试仪12上。如上所述，题述发明还适用于连续的分析物监测系统和药物注射设备。
本发明还可以用于为用户注射药剂的注射系统，例如，胰岛素注射系统。这种注射系统可以是完全可植入系统或外部系统。外部注射设备典型地连接至包含套管的注射设备，以注射选择的药剂剂量，所述套管是经皮地穿过病人皮肤而放置的。例如，外部胰岛素注射设备典型地连接至包含套管的注射设备，从而基于注射设备的编好程序的基本速率或其他任何由病人的HCP规定的注射速率来注射选择的胰岛素剂量，所述套管是经皮地穿过病人皮肤而放置的。在配戴或操作注射设备(例如，在饭前进行碳水化合物推注(bolus)给药)的过程中，用户可以控制胰岛素泵设备来进行附加剂量的胰岛素的给药。某些注射设备可以包括食物数据库(其与碳水化合物的量有关)，从而病人可以更好的估计需要用来(例如)计算推注的胰岛素剂量的水平。
图2是供本发明使用的胰岛素传送的示例性实施例的框图。一个实施例中的胰岛素传送设备620包括：处理器710，耦合至存储器单元740、输入单元720、显示单元730、输出单元760、以及流体传送单元750。在一个实施例中，处理器710包括微处理器，其被配置为并能够通过控制和/或访问胰岛素传送设备620多个部件中的每一个来控制胰岛素传送设备620的功能。在一个实施例中，可以配置多个处理器作为安全措施，并在单个处理器出现故障时提供备份。此外，胰岛素传送设备620中的多个处理器单元之间可以共享处理容量，从而执行泵功能和/或控制就会更快更精确。
耦合至处理器710的输入单元720可以包括转点通(jog dial)、键盘按钮、触摸屏、或其他任何适合的输入机构，以将输入命令提供至胰岛素传送设备620。更具体地，在转点通输入设备、或触摸屏的情况下，例如，胰岛素传送设备620的病人或用户可以连同作为数据输入和输出单元工作的显示单元730一起操控相应的转点通或触摸板。显示单元730可以包括触敏屏幕(touch sensitive screen)、LCD屏、或其他任何类型的适用于胰岛素传送设备620的显示单元，其被配置用来向病人显示文字数字数据以及诸如与胰岛素传送设备620的一个或多个预先定义的状态相关的图标的图示信息、或者诸如与胰岛素注射速率相关的趋势图和图表的数据的图示、在一段时间内监测的葡萄糖水平的趋势数据、或者文本通知。
耦合至处理器710的输出单元760可以包括音响警告器，其包含一个或多个音调和/或预编程或可编程的音调或声音素材，或者包括振动警报部件，其具有一个或多个预编程或可编程的振动报警电平。在一个实施例中，振动警报还可以协助灌装注射导管，以最小化注射导管中潜在的空气或其他不期望的材料。还示出了流体传送单元750，其耦合至处理器710并用于经注射装置将胰岛素剂或量从胰岛素传送设备620中的胰岛素容器或其他任何类型的适合传送胰岛素的容器(未示出)中传送给病人，所述注射装置耦合至病人皮肤下的经皮放置的套管。
存储器单元740可以包括一个或多个随机存取存储器(RAM)、只读存储器(ROM)、或其他任何类型的数据存储单元，其可以用于存储数据以及程序指令，所述程序指令通过处理器710进行访问，并执行以控制胰岛素传送设备620和/或基于从例如分析物监测系统610、远程端640(HCP或护理者)、病人630或其他任何数据输入源(例如，见图3)接收的数据来执行数据处理。
图3是示出了包含胰岛素注射设备和分析物监测系统的胰岛素治疗管理系统600的框图。胰岛素治疗管理系统600包括耦合至胰岛素传送设备620的分析物监测系统610，其还可以耦合至远程端640。在一个实施例中，分析物监测系统610耦合至病人630，以监测或测量病人的分析物水平。此外，胰岛素传送设备620使用例如注射装置和连接至套管(cannula)(未示出)的管来耦合至病人，从而将药物(例如胰岛素)注射给病人，所述套管经病人皮肤经皮地放置。
在一个实施例中，分析物监测系统610可以包括一个或多个置于皮下的分析物传感器，从而至少一部分分析物传感器与病人的分析物仍保持流体接触。分析物传感器可以包括但不限于短期皮下分析物传感器或通过皮肤的分析物传感器，例如，其用于检测一段预定时间内病人的分析物水平，而这段时间之后，更换传感器是必要的。
分析物监测系统610的一个或多个分析物传感器耦合至相应的一个或多个数据发送器单元，其用于从对应于检测的病人分析物水平的相应分析物传感器接收一个或多个信号，并用于将对应于检测的分析物水平的信息传送给接收器设备，和/或胰岛素传送设备620。即，在通信链接上，发送器单元可以用于将与检测的分析物水平相关的数据周期性地、和/或间歇地并且重复地传送至一个或多个其他设备，诸如胰岛素传送设备和/或远程端640，用于进一步的数据处理和分析。分析物监测系统610的发送器单元在一个实施例中可以用于在从对应的分析物传感器中接收到与分析物相关的数据之后，基本上实时地向胰岛素传送设备620和/或远程端640发送与分析物相关的数据，从而诸如病人630的血糖水平的分析物水平可以进行实时监测。
分析物监测系统610的发送器单元可以用于直接与一个或多个远程端640或胰岛素传送设备620进行通信。此外，在本发明的范围内，可以在胰岛素治疗管理系统600中配置用于通信的附加设备，包括附加接收器/数据处理单元、远程端(例如HCP端和/或医院环境中的床边端(bedside terminal))。
在一个实施例中，胰岛素传送设备620可以包括但不限于外部注射设备，诸如外部胰岛素注射泵、可植入泵、笔型胰岛素注射器设备、贴附式泵(patch pump)、用于鼻胰岛素传送的可吸入注射设备、或其他任何类型的适合的传送系统。
在一个实施例中，分析物监测系统610包括测试条端口，用于容纳测试条，以进行毛细血管血糖检测。一方面，使用测试条测量的葡萄糖水平可以附加地用于提供对分析物监测系统610中的分析物传感器的周期性校准，以确保并改进由分析物传感器检测的分析物水平的精确度。
可以适用于本发明的示例性的体内和体外分析物监测系统和药物注射系统包括但不限于那些在美国专利第6,175,752号、第6,329,161号、第6,284,478号、第6,916,159号、第7,041,468号、第7,077,328号，以及美国专利申请号第11/383,945号、第11/365,168号、第11/386,915号、第11/396,181号、第11/396,182号中以及在别处描述过的内容，其全部内容通过引证结合在此。
根据本发明的方面，警报(alert)和/或警告(alarm)32还可以在显示器18中示出，其指示，例如当前测量是否落入预定范围(诸如理想的葡萄糖范围、适度关注的较高范围或较低范围或者高度关注的较高范围或较低范围)。
现在参照图4，示出了警报和警告显示器32的另一实例。陡峭地向下倾斜的箭头34(例如，从约-60度到约-90度)可以用来表示高度关注的较低范围中的葡萄糖读数，诸如50mg/dL以下。适度地向下倾斜的箭头36(例如，从约-30度到约-45度)可以用来表示适度关注的较低范围中的葡萄糖读数，诸如约50mg/dL到约75mg/dL。水平箭头38(例如，约0度)可以用来表示理想范围内的葡萄糖读数，诸如约75mg/dL到约175mg/dL。适度地向上倾斜的箭头40(例如，约30度或约45度)可以用来表示适度关注的较高范围中的葡萄糖读数，诸如约175mg/dL到约250mg/dL。最后，陡峭地向上倾斜的箭头42(例如，从约60度到约90度)可以用来表示高度关注的较高范围中的葡萄糖读数，诸如约250mg/dL以上。如前所述，多种其他的可视元件和/或可听的或物理的指示器均可以用于为用户提供警报或警告。
现在参照图5，示出了用户的血糖值的实例。曲线100表示在一天当中的一段时间里用户的血糖是如何随时间变化的。在这个实例中，用户的理想范围是约75mg/dL到约175mg/dL，以参考标记110示出并由虚线112和114划界。适度关注的范围是约50mg/dL到约75mg/dL(下部警报区116，由虚线112和118划界)以及约175mg/dL到约250mg/dL(上部警报区120，由虚线114和122划界)。高度关注的范围在约50mg/dL以下(下部警告区124，在虚线118之下)以及约250mg/dL以上(上部警告区126，在虚线122之上)。
在图5中，葡萄糖值(100)从约150mg/dL开始，上升至约195mg/dL(101)，落至约155mg/dL(102)，升至约270mg/dL(103)，落至约60mg/dL(104)，升至约90mg/dL(105)，落至约40mg/dL(106)，并在约100mg/dL处结束。
图6示出了与图5相同的血糖值100，但增加了由用户执行的检测，其中的一些是由于提醒(警报和/或警告和/或提醒)而发生的。例如，在零食(小吃)之后，用户检测读数为193mg/dL(201)，落入上部警报区(120)。这个读数可以使测试仪12向用户产生警报，例如，闪烁显示、发嘟嘟声等，该警报为他或她的葡萄糖处于适度关注的较高水平，如前所述。在确定读数在上部警报区之后，或者如上所述某些时候从那之后，测试仪可以基本上立即地向用户发警报。不考虑用户是否被立即告知读数处于警报区(或本文描述的其他区)，测试仪还可以用来提醒用户在紧随读数处于重要性区域(警告区或警报区)的预定时间之后执行重复检测。例如，在上述的测试仪读数处于上部警报区120中之后，测试仪提醒信号会通知用户在预定时间(例如，约5分钟，例如，约10分钟，例如，约20分钟，例如，约30分钟等)执行检测，并可以周期性地提醒用户，直到执行检测，或直到用户清除提醒信号。例如，用户可以响应读数并以适当的治疗来进行警报(如果警报的话)，而一段时间之后(例如，约30分钟)，提醒信号提示用户进行检测，从而导致读数160mg/dL(202)落入理想区(110)。
随后，在正餐之后，用户检测出读数为268mg/dL(203)，其落入了上部警报区(126)。该读数使测试仪12向用户产生警告，该警告为他或她的葡萄糖处于高度关注的较高水平。用户以适当的治疗响应读数，而一段时间之后(例如，20分钟)，提醒信号提示用户进行检测，从而导致读数232mg/dL(204)落入上部警报区(120)。该读数使测试仪12向用户产生警报，该警报为他或她的葡萄糖处于适度关注的较高水平。用户可以注意到，前面的治疗是恰当的，并且再一次，一段时间之后(例如，30分钟)，提醒信号提示用户再一次进行检测，导致读数156mg/dL(205)落入理想区(110)并确定前面的治疗是恰当的。
再后一点，在未进食但已运动之后，用户感觉到轻微的症状并检测出读数61mg/dL(206)，其落入下部警报区(116)。该读数使测试仪12向用户产生警报，该警报为他或她的葡萄糖处于适度关注的较低水平。用户通过吃零食(小吃)来响应，而一段时间之后(例如，25分钟)，提醒信号提示用户进行检测，导致读数81mg/dL(207)落入理想区(110)。
再后一点，用户感觉到症状并检测出读数41mg/dL(208)，其落入下部警告区(124)。该读数使测试仪12产生警告，指示葡萄糖水平处于高度关注的较低水平。用户通过适度进餐来响应，而一段时间之后(例如，15分钟)，提醒信号提示用户进行检测，导致读数63mg/dL(209)落入下部警报区(116)。该读数使测试仪12产生警报，指示葡萄糖水平现在处于适度关注的较低水平。用户可以注意到，前面的治疗(进餐)是恰当的，或者可以吃少量食物(小吃)，并且再一次，一段时间之后(例如，25分钟)，提醒信号提示用户进行检测，导致读数99mg/dL(210)落入理想区(110)并确定治疗的过程是恰当的。
应注意，在本实例中，检测201、203、206和208是由用户基于用户所知的使血糖变化的事件或基于用户经历的症状而发起的。更重要地，用户被提示来通过根据本发明一方面构造的测试仪执行检测202、204、205、207、209和210。这些提示或定时的提醒协助用户及时地执行恰当的检测。这些检测又简化了用户的重要目标，即，将他或她的血糖水平保持在理想区110，从而保证用户的短期和长期健康。
实施例还包括监管人可控的、包含个人限制(例如，用户限制)的医疗设备。该医疗设备的配置是可由监管人(例如，HCP、父母或监护人、护理者等)(例如)远程地或通过直接动作(例如，使用设备的用户界面等)来进行设定和/或锁定的。例如，医疗设备的某些配置可以由具有第一访问等级(例如，诸如完全读/写权限的完全访问)的第一人(例如，HCP)设定和/或锁定，而某些配置可以由具有第二访问等级(例如，有限的读/写权限)的第二人(例如，护理者)设定和/或锁定。该医疗设备可以由具有第三访问等级(例如，更为有限的，例如只读-不包括任何修改之前输入的数据的权利)的第三人(例如，在第一人和第二人的监管下的用户)设定和/或锁定。任何数量的人均可以具有某些或有限的对医疗设备的访问权利。例如，某些实施例包括具有某些可由HCP设定和/或锁定的配置的医疗设备，以及可由护理者设定和/或锁定的某些其他部件。用户可以完全受限而不能修改由HCP和/或护理者设定的配置。
配置可以使用访问码(例如，密码保护、语音验证、USB令牌(token)保护、或其他验证用户的方式)来控制访问，以使特定个体、医疗设备、计算机、或个体的组具有访问权限。当设置权限时，对个体、计算机、或组授予访问的类型和等级。如上所述，例如，读和写以及查看权限的多种等级可以授予不同的人。
不同编码可以提供不同的权利。例如，HCP码可以使HCP输入规定信息和/或删除和/或修改存储的规定(“Rx”)信息，其中，规定信息广泛地定义了由HCP规定的相关信息。规定信息可以包括病人特定的数据并可以包括但不限于一个或多个基本速率、胰岛素理想分析物范围、警报和警告阈值、药物类型(例如，胰岛素类型)、包含全日剂量(例如，全日胰岛素剂量)的药物剂量、药物敏感度(例如，胰岛素敏感度)、何时用药、如何用药、何时处理健康状态、如何处理健康状态、何时向HCP或护理者提升关注程度，提醒方案(例如，设定提醒时间)等。上述并不是完整的列表，例如，对于治疗糖尿病，信息还可以包括胰岛素/碳水化合物信息，以及其他相关信息。如此，医疗设备可以由HCP定制，以包括用户特定的规定信息，其中的一些可能与医疗设备中的值或设定不相关，但仅为了参考的目的还是可以得到的(例如，诸如那些通常显示在PDA上的文本通知等等)。医疗设备可以由HCP锁定，HCP还可以为他人(诸如护理者和/或用户)设置访问等级。这样，HCP(或者其他规定的个体)可以用作“管理员”，其具有在点级别(granular level)上控制访问的能力，一个人接一个人地建立访问等级。
除了HCP提供的配置，护理者还可以输入和/或锁定医疗设备的配置。如上所述，在很多实施例中，在护理者控制下的至少某些配置与为HCP控制而储存的配置至少部分地不同，这实质上是规定的。护理者访问可以使护理者能够输入护理者信息和/或删除和/或修改存储的护理者信息。护理者信息包括但不限于设定和锁定任意值或用户限制(之前未被HCP设定和锁定)的能力，诸如非规定警报值、用户菜单访问、以及其他用户特权，诸如数据传送(例如，上载至PC)以及存储选择(例如，对多种数据的只读或读-写访问)。例如，HCP可以设定和锁定值和允许的选择(例如，锁定菜单)。由HCP允许的护理者访问可以设定并锁定没有被HCP锁定的信息。护理者访问可以为护理者提供锁定和/或解锁用户特征的能力，诸如为用户提供随时间增多的访问，因为用户会开始明白和理解各种特征的微妙与复杂(例如，设定诸如警告阈值和提醒时间值的正确的值，或访问示出了当理解不当时可能会迷惑的信息的菜单)。类似地，用户能够访问护理者(和HCP)允许的信息，并可以设定未被锁定的信息。
可以通过使用(例如)用户界面将数据直接输入至医疗设备来设定和/或锁定配置，或者可以间接完成，包括远程地完成，例如，经由连接至网络的计算机系统，其中网络表示任何适于通信数据的单向或双向的通信链接，诸如广域网、局域网、或全球计算机网络，如万维网(即“网”)。因而，实施例包括根据给定的个人的权限等级使人能够控制访问和/或操控和/或分享信息的基于网络的数据管理系统。每个HCP和/或护理者和/或医疗设备用户可以经网络与适用于访问数据管理系统的计算设备进行互相作用。例如，可以使用个人计算机、膝上型计算机、诸如手机的电话、个人数字助理(PDA)等。为了与数据管理系统进行通信，通信设备典型地执行通信软件，尤其是网页浏览器，诸如华盛顿雷蒙德的微软的INTERNETEXPLORER等等。
一旦由例如HCP、护理者或用户设定了配置，存储的信息就可以在执行健康护理管理(例如，葡萄糖监测)过程中由医疗设备使用。存储的信息可以通过听觉和/或视觉和/或触觉的形式传达给用户。例如，由HCP输入的规定信息可以(例如)以图标的形式(如“Rx”图标等，作为通知(note)，这与显示的PDF通知类似)可视地显示在医疗设备的显示器上，或可以是听觉或触觉的形式。
图7A示出了具有限制性控制(例如，限制性护理者和用户控制)的医疗设备300的实施例的分级的权限方案。最重要的设定和用户界面的部分(例如，设定值以及激活菜单项的能力)可以由HCP设定。必须由HCP规定的值位于由虚线310划界的用户界面的HCP专用(HCP Only)部分。由HCP规定的附加值包含在由实线330划界的HCP设定区域320中。例如，HCP可以将访问限制在多种选择或菜单(例如，数据传输和存储参数)，并可以设定和锁定多种值，例如，高度关注的较低阈值以及相关的警告参数。护理者(例如，父母)可以通过由实线350划界的护理者设定区域340设定附加限制。例如，护理者可以设定和锁定之前未锁定的高度关注的较高阈值以及相关的警告参数，并设定其他阈值的优选值和相关警告参数，而不锁定那些值(即，用户可以稍后更新那些值)。最终，医疗设备的用户被允许访问由实线360划界的用户界面的用户允许部分，以及包含用户界面的用户区域370的永远允许的用户界面部分。
图7B示出了图7A的医疗设备300，但在本实施例中，不存在护理者，而用户区域370包括不受HCP设定区域320中HCP的限制的用户界面的所有部分。
图8示出了经连接410(可以是有线或无线)连接至数据管理系统(DMS)400的医疗设备300。DMS 400可以连接至仅示出了一个的多个医疗设备，而每一个均是类似或不同的类型(例如，分析物测试仪(诸如血糖测试仪)、连续分析物监测器(诸如连续葡萄糖监测器)、药物注射泵(诸如胰岛素泵)。
图9示出了在DMS 400上运行的应用软件(SW)，其中DMS应用SW 500经连接410连接至医疗设备(未示出)。SW 500可以在计算机可读介质上实施。DMS应用SW 500还分别经SW连接540、550和560连接至HCP应用SW 510、护理者应用SW 520、以及用户应用SW 530。HCP、护理者和用户应用SW模块的每一个对那些在医疗设备上直接设定的信息均具有相同的受限制的用户控制(例如，权限和限制)，同时允许了更为完整的用户界面，诸如那些经常在PC计算机上找到的图形用户界面(GUI)。通过GUI仅在DMS 400上可用的附加软件(例如，更先进的数据图形软件)还可以经历相似的受限制的用户控制，如对医疗设备的描述。
对于有关本发明的其他细节，可根据相关领域技术人员的水平范围来使用材料及生产技术。在其他普遍地或逻辑上采用的本发明的基于方法的方面同样适用。此外，还可考虑提出所描述的发明性变型的任何可选特征并独立地要求保护，或与本文所描述的特征中的任意一个或多个相结合进行保护。同样地，参照单个项目，包括了存在多个相同项目的可能性。更具体地，如本文及所附权利要求中所用的，除非上下文中有清楚的说明，单数形式的“一个”、“一种”、“所述”以及“该”包括了多个所指物。进一步指出所撰写的权利要求排除了任何可选因素。这样，这种表述意在用作这种排他性术语如“单独地”、“仅仅”等的使用的先前基础，或用作一种“消极”限制。除非本文中有其他限定，所有的技术术语和科学术语均具有于本发明所属领域的普通技术人员的通常理解相同的含义。本发明不限于说明书所述的对象，而是仅由所附权利要求所采用的通常术语所限定。

Claims (25)

1.一种用于向用户注射药物的医疗设备，所述设备包括：
注射设备，用于向病人注射药物；以及
用户界面，用于向所述用户传达注射信息，
其中，所述医疗设备的配置是通过监管人可设定的，并
通过使用访问码可锁定的。
2.根据权利要求1所述的医疗设备，包括数据管理系统。
3.根据权利要求1所述的医疗设备，其中，所述配置是远程可设定和可锁定的。
4.根据权利要求3所述的医疗设备，其中，所述医疗设备可连接至计算机网络，并且所述配置是经由所述网络可设定和可锁定的。
5.根据权利要求1所述的医疗设备，其中，所述医疗设备包括多个访问码。
6.根据权利要求1所述的医疗设备，其中，所述医疗设备包括至少两个访问码。
7.根据权利要求6所述的医疗设备，其中，所述医疗设备包括健康护理专家访问码和护理者访问码。
8.根据权利要求7所述的医疗设备，其中，所述医疗设备进一步包括用户访问码。
9.根据权利要求1所述的医疗设备，其中，所述监管人是健康护理专家或护理者。
10.根据权利要求9所述的医疗设备，其中，所述医疗设备对用户进行访问限制。
11.根据权利要求1所述的医疗设备，其中，所述监管人是健康护理专家。
12.根据权利要求11所述的医疗设备，其中，所述配置包括用于提醒用户采取行动的提醒信号。
13.根据权利要求11所述的医疗设备，其中，所述配置包括注射信息。
14.根据权利要求13所述的医疗设备，其中，所述注射信息包括推注信息。
15.根据权利要求11所述的医疗设备，其中，所述配置是规定的。
16.根据权利要求15所述的医疗设备，其中，所述配置包括药物治疗信息。
17.根据权利要求11所述的医疗设备，其中，在所述医疗设备上向所述用户传达的通知是由所述健康护理专家远程输入的。
18.根据权利要求1所述的医疗设备，其中，所述监管人是护理者。
19.根据权利要求1所述的医疗设备，其中，用户对所述医疗设备的访问是受限制的。
20.根据权利要求19所述的医疗设备，其中，所述的受限制的访问包括不能修改监管人设定的配置。
21.根据权利要求1所述的医疗设备，其中，所述注射设备是胰岛素注射设备。
22.根据权利要求1所述的医疗设备，其中，所述医疗设备连接至分析物监测系统。
23.一种医疗系统，包括：
葡萄糖监测系统；
胰岛素泵；以及
数据管理系统，可连接至所述葡萄糖监测系统或所述泵，或者同时连接至所述葡萄糖监测系统和所述泵，所述数据管理系统具有权限分级，所述权限分级使多个个人能够具有不同的权限权利来输入和修改所述葡萄糖监测系统或所述泵或者所述葡萄糖监测系统和所述泵二者中的数据。
24.一种限制性控制的医疗系统，包括：
注射设备；以及
用户界面，用于向用户传达注射信息，
其中，所述用户界面的多个部分被分配有标识符，以提供对所述多个部分的受限制的访问。
25.一种由用户使用的医疗系统，包括：
医疗设备，用于注射药剂，并被配置为使除所述设备的用户之外的至少一个人能够设定所述设备的参数，其中所述参数不能由所述用户进行设定或修改。
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