CN1859943A - 利用和单针或多针真皮内 ( i d )传送器件耦合的反馈式或基于模型的控制器启动并保持患者体内某物质浓度的连续、长期控制的系统和方法 - Google Patents

利用和单针或多针真皮内 ( i d )传送器件耦合的反馈式或基于模型的控制器启动并保持患者体内某物质浓度的连续、长期控制的系统和方法 Download PDF

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CN1859943A
CN1859943A CNA2003801055162A CN200380105516A CN1859943A CN 1859943 A CN1859943 A CN 1859943A CN A2003801055162 A CNA2003801055162 A CN A2003801055162A CN 200380105516 A CN200380105516 A CN 200380105516A CN 1859943 A CN1859943 A CN 1859943A
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insulin
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史蒂文·基思
罗纳德·派蒂斯
诺埃尔·哈维
约翰·D·德努齐奥
罗伯特·S·帕克
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Abstract

一种用于在用户体内控制某物质的浓度，例如血葡萄浓度的闭环治疗系统(200)。该系统和方法使用一个测量体内葡萄糖水平的传感器系统(206)以及一个利用测到的葡萄糖水平生成输出的控制器(202)，可以利用该输出自动地或手动地控制真皮内胰岛素注入系统(204)以对用户设定固定的或随时间变化的目标血葡萄糖浓度分布，并且接着对用户身体注入恰当量的胰岛素从而达到并保持血葡萄糖浓度的目标值。

Description

利用和单针或多针真皮内(ID) 传送器件耦合的反馈式或基于模型 的控制器启动并保持患者体内 某物质浓度的连续、长期控制的系统和方法
技术领域
本发明涉及一种对患者体内某物质的浓度保持连续、长期的控制并且确定所述物质的目标浓度的固定或者时变分布的系统和方法。更具体地说，本发明涉及一种利用控制算法，例如和胰岛素的真皮内(ID)传送耦合的反馈或基于模型的控制器，把糖尿病患者的血葡萄糖浓度保持在目标分布附近的连续、长期控制的系统和方法，其中该胰岛素最好是通过单针或多针阵列传送的短期作用胰岛素类似物。本申请根据35U.S.C.§119(e)要求2002年10月11日归档的临时专利申请60/417,559号以及2002年12月11日归档的临时专利申请60/432,233号的利益，这二份临时专利申请的整个内容收录作为参考。
背景技术
近来证明胰岛素的真皮内(ID)传送要比胰岛素的皮下(SC)传送造成治疗的更快摄取和清除。这种快速作用减小注入(例如，控制器命令的注入)和患者响应间的延迟时间。
胰岛素的ID传送还避免和静脉内(IV)传送关联的复杂性，从而可以有效地在反馈控制的胰岛素传送系统中采用。反馈控制系统操作成根据系统的某个测量，例如对血液或组织的葡萄糖的测量，和设定点的比较调节某个控制变量(例如胰岛素传送速率或体积)。这种反馈控制系统可能采用包含测量信号以及该信号的积分或求导的计算，从而性能上会受到和所控制的系统关联的时间延迟的限制。这些时间延迟例如可以归因于传送的药品以及它的目标的药物动力学(PK)和药效学(PD)、测量部件固有的延迟以及计算时间。
从而，应注意到，任何减小例如胰岛素的ID传送中造成的时延可以提高这种反馈控制器的性能能力。另外，任何缩短治疗效果，例如通过ID传送或者使用短期作用胰岛素类似物，可以提高这种反馈控制系统的性能。由于除了等待效能的自然PK/PD衰退之外，胰岛素传送系统不能对患者去掉胰岛素，较短的治疗时间允许更灵活和更灵敏的控制器。
另外，一些类型的患者模型结构，即一些基于生理学的模型，要求患者经历胰岛素反应检查，该检查的时间是由采样率和胰岛素反应的持续时间决定的。使用短期作用胰岛素相对于使用常规胰岛素缩短该时间要求。类似地，对常规胰岛素采用ID传送相对于SC传送缩短该时间要求。但是，使用真皮内传送短期作用胰岛素甚至会进一步缩短该时间，因为可以缩短反应分布以及可能的采样间隔。
此外，即使在基于非生理模型，例如3隔室最小模型，的情况下，最好为患者生成一些胰岛素灵敏性参数。通过使用一种提供快速和短期有效的响应，例如通过短期作用胰岛素的ID传送提供的响应，可以缩短这种检查的持续时间。
而且，任何用于葡萄糖的反馈控制系统典型地需要测量并发送葡萄糖浓度的传感器。该传感器测量动脉、静脉或者间质流体浓度并且可位于臂上或腿上。从而在动脉葡萄糖和感测到的葡萄糖浓度之间存在可能固有的延迟，其程度可达30-40分钟。用较短的采样间隔操作的控制系统能容忍传感器上的更大延迟。传感器延迟也可能是暂时性的，例如由通信中的短暂中断、传感器的意外接触或移动等等造成的延迟。从而更频繁地询问传感器有允许更快地确定问题并且能一旦克服问题后更快地返回到控制上。
已经试图利用胰岛素的静脉内传送或者相对长的采样间隔下的短期作用胰岛素的SC传送实现对糖尿病患者的血液葡萄糖水平的控制。IV传送通常是有问题的，因为它需要对患者侵入植入泵或传送器件。在采用带有长采样间隔的相对不侵入的SC传送的系统中，控制性能降低。
还应注意目前存在按远程隔室中的血浆胰岛素和胰岛素浓度的函数描述血浆葡萄糖浓度的三状态模型。但是，该模型过度估计葡萄糖浓度在细胞葡萄糖摄取上的影响并且对升高的胰岛素水平的影响估计不足。这造成观察到的生理现象的不匹配，从而该三状态模型会降低控制器的性能。
此外，控制器的目标典型地是把全身参数(例如，血液葡萄糖)保持在目标值(例如，80或100mg/dl)上或附近。由于未控制糖尿病患者的血液葡萄糖水平典型地大大高于期望的目标水平，当第一次对新患者应用控制器时，当前的葡萄糖水平和目标水平之间可能存在大的差异。如果指示控制器，例如模型预测控制器(MPC)，在最短的可能时间把患者的血液葡萄糖从高血糖值降到典型目标值，结果会是快速输入胰岛素，这可能反而造成低血糖。如果指示MPC控制器把患者保持在当前的高血糖状态，接着逐渐把目标葡萄糖降到典型的目标值，结果会是逐渐输入胰岛素并大大降低低血糖的可能。
启动控制器的常规方式是使患者的葡萄糖水平降到接近控制开始前的目标。可以通过人工胰岛素注入和/或控制葡萄糖摄入。但是，尽管技术上简单，该方法对于患者是耗时的和不可靠的。
总体上和上述专注的领域相关的系统和部件的例子在美国专利6,558,351、6,441,747、5,569,186、5,558,640、4,494,950和4,475,901号中、在发表的美国专利申请US 2002.0095134A1号(由BectonDickinson and Company拥有)中、在发表的欧洲专利申请EP 1048264A1号、在发表的国际专利申请WO 00/74753A1号中、在发表的国际专利申请WO 02/02179号中说明，并且在以下文献中说明RobertParker and Francis Doyle，Advances in Drug Delivery Reviews 48，pp.211-228(2001)；Parker，R.S.，Doyle，F.J.，Peppas，N.A.TheIntravenous Route to Blood Glucose Control IEEE Engineering inMedicine and Biology，pp.65-73(2001)；Parker，R.S.，Doyle，F.J.，Peppas.N.A.A Model-Based Algorithm for Blood Glucose Control inType I Diabetic Patients IEEE Transactions on BiomedicalEngineering，46(2)，pp.148-157(1999)；“Investigational device mimicsa pancreas，brings an artificial pancreas one step closer to reality”ADA Annual Meeting-SAN FRANCISCO-June 17，2002(obtainedfrom，www.medtronics.com)；The ADICOL (Advanced InsulinControl using a closed Loop)Consortium(www.adicol.org)；Biostatoralgorithm(Clemens，A.H.，Feedback Control Dynamics for GlucoseControlled Infusion System Med Prog Technol，6，pp.91-98(1979)；Parker，R.S.，et al.，Robust H-infinity Glucose Control in DiabetesUsing a Physiological Model，AIChE J.46(12)，pp.2537-2549(2000)；Shimoda，S.et al，Closed-loop subcutaneous insulin infusion algorithmwith a short-acting insulin analog for long-term clinical application ofa wearable artificial endocrine pancreas，Frontiers Med.Biol. Engng8(3)：197-211(1997)；Sorensen，J.T.，A Physiologic Model of GlucoseMetabolism in Man and its Use to Design and Assess Improved InsulinTherapies for Diabetes，PhD Thesis，M.I.T.(1985)；Chassin，L.J.et al.，Simulating closed-loop glucose control；Effect of delay in  glucosemeasurement.Diabetes 51：1606 Suppl.2.(2002)；Chassin，L.J.和Hovorka，R.，Closed-loop glucose control with IV glucose samplingand SC insulin infusion：Evaluation by simulation studies，Diabetologia 44：792 Suppl.1(2001)；以及R.S.Parker，F.J.Doyle III，J.E.Harting，和N.A.Peppas，Model Predictive Control for InfusionPump Insulin Delivery，Proceedings of the IEEE Engineering inMedicine and Biology 18th Annual International Conference，Paper no.265，Amsterdam，The Netherlands，1996。这些文献的整个内容收录作为参考。
从而，需要一种这样的系统和方法，其能解决这些问题，尤其能用于向患者传送胰岛素并使低血糖的发生为最小的最小侵入ID传送器件，而且其能保持患者体内的期望血葡萄糖浓度，同时还能以高采样率操作从而不会降低控制性能。
发明内容
本发明的一个目的涉及一种系统和方法，用于对患者体内某物质的浓度保持连续、长期的控制，并且用于确定所述物质的期望浓度的时间相关分布，所述期望浓度是固定的或者随时间变化。
本发明的另一个目的是提供一种系统和方法，用于利用控制算法对糖尿病患者的血葡萄糖浓度保持连续、长期的控制，并且用于确定期望葡萄糖浓度的时间相关分布，所述期望葡萄糖浓度是固定的或者随时间变化。
本发明的再一个目的是提供一种采用可以在高采样率下使用从而不会降低控制性能的最小侵入ID传送器件的系统和方法。
实质通过提供一种控制患者体内某物质的浓度的控制系统和方法达到这些和其它目的。该控制系统和方法使用一个传送器件和一个控制器，该传送器件适于真皮内地向患者传送某材料以便更快速地摄取该材料并且更快速地清除该材料，而该控制器适于确定患者体内响应对该患者传送该材料出现的该物质的浓度并且提供适用于控制该传送器件的输出以便根据该物质的浓度控制对该患者传送的该材料的量。例如，可以对该传送器件提供该输出以便自动控制该传送器件。替代地，该输出例如可以是以显示为形式的和该物质浓度相关的信息，其可以由患者或者该器件的用户读取，接着他可手动地调节该传送器件以把恰当数量的材料注入患者。在一应用中，该材料包括短期作用胰岛素而该物质包括葡萄糖，从而该控制器根据患者组织中响应胰岛素传送的葡萄糖浓度控制对患者的该短期作用胰岛素的真皮内传送。该传送器件可以由适于真皮内地向患者传送材料，例如短期作用胰岛素，的单针或多针阵列构成。该系统还包括一个适于检测患者体内该物质的浓度，例如葡萄糖水平，并且向该控制器提供表示该浓度的信号的传感器，接着该控制器分析该信号以便如上面讨论那样确定葡萄糖的浓度。
该系统和方法还使用一个适于对该系统供能的自备电源以及一个适于存储充当要对患者传送的材料的胰岛素的胰岛素存储器件。该系统还可以是便携式的和可由患者戴上的，并且至少一部分的控制器、传感器和传送器件之间的通信包括无线通信。该控制器还适于和系统外部的某部件通信以在该控制器和患者、康健提供商或者二者之间中继信息。
该控制器还可以使用一个包括基于生理的模型的控制模型。该控制器还可以使用一个算法，以便使传送胰岛素前存在的传送前的葡萄糖浓度和目标或预期葡萄糖浓度比较，并且接着使传送胰岛素后存在的传送后的葡萄糖浓度和目标或预期葡萄糖浓度比较。接着该算法根据这些传送前和传送后的比较进一步确定适当的胰岛素剂量。该控制器还可以根据传送后的葡萄糖浓度和该目标或预期葡萄糖浓度的比较调整该模型。该控制器还允许估计人体中未直接测量区域内某物质例如葡萄糖的浓度，例如根据间质流体葡萄糖测量估计动脉葡萄糖(这种实现在“状态估计”技术上是周知的)。此外，在所述和目标或预期浓度的比较中，该控制器可以使用对该物质的浓度的测量或者使用对该物质的浓度的估计。
该系统和方法还适于调节患者体内某物质，例如血葡萄糖的浓度。该系统和方法使用一个适于利用该物质浓度的目标分布的控制器以及一个适于在该控制器的控制下真皮内地向患者传送某材料例如胰岛素的传送器件，以便实质上根据该目标分布把该物质的浓度调节到该目标浓度上。
附图说明
从下面的在连带着附图下阅读的详细说明，本发明的这些和其它的目的、优点和新颖特征会更容易地得到理解，附图中：
图1是依据本发明的一实施例的一个采用反馈控制的药品传送系统的例子的方块图；
图2是依据本发明的一实施例的一个采用反馈控制的胰岛素传送系统的例子的方块图；
图3示出图2示出的系统中使用的胰岛素传送器件和感测器件的例子；
图4是图3中示出的器件的针阵列的详细平面图；
图5是图3中示出的器件的针阵列的详细透视图；
图6是依据本发明的一实施例的采用基于模型的控制例如模型预测控制器(MPC)的胰岛素传送系统的一个例子的方块图；
图7包括通过能利用表下(SC)和真皮内(ID)胰岛素传送方法复制猪胰岛素响应分布曲线的模型得到的采样响应曲线；
图8的曲线示出通过图6中示出的控制系统实现的餐中和餐后的糖尿病患者的控制模型例子；
图9的曲线示出通过图6中示出的控制系统实现的三天的糖尿病患者的控制模型例子；
图10的曲线示出通过图6中示出的控制系统实现的三天的糖尿病患者的控制模型例子；
图11的曲线示出糖尿病患者的三餐控制模型的例子；
图12的曲线说明能复制人类对胰岛素的响应分布曲线的模型；
图13的表说明由图6中示出的系统实现闭环治疗；
图14的曲线说明一个在设定平的目标情况下通过图6中示出的胰岛素传送系统实现的葡萄糖浓度曲线和胰岛素注入率曲线的例子；以及
图15的曲线说明一个在设定斜坡目标情况下通过图6中示出的胰岛素传送系统实现的葡萄糖浓度曲线和胰岛素注入率曲线的例子。
具体实施方式
在图1-5中示出依据本发明的实施例的系统。如图1中所示，系统100通常可以按一个包括控制器102、药物传送系统和分析物传感器系统106的药物传送系统配置。如指出的那样，控制器102提供控制药物传送系统104的控制信号以向患者108传送适当量的药物。分析物传感器系统感测患者108体内感兴趣的分析物的水平并向控制器102提供传感器信号。还对该控制器输入指示该分析物的目标水平的基准或设定点信号。控制器102接着可以根据传感器信号和基准信号相应地调节控制信号从而调节药物传送系统104对患者108传送的药量。
如图2中所示，系统100可配置在通常称为人造胰腺的便携式、可戴的闭环胰岛素传送系统200内。类似于系统100，系统200包括控制器202、胰岛素传送系统204和葡萄糖传感器系统206。如后面更详细讨论那样，控制器202提供控制胰岛素传送系统204的控制信号以向患者208传送适当量的胰岛素。胰岛素传送系统204可以包括如图3-5所示的针阵列210。具体地，针阵列210包括多个针212，每个针的直径和长度足以真皮内地向患者208传送(ID传送)胰岛素。例如，每个针可以具有约从0.3mm到约3.0mm范围的长度，并且具有约从30号到约50号规格(gauge)范围的直径。
如业内人士理解那样，微型针包括直径等于或小于30号规格的结构，并且当这种结构本质上为圆柱形时典型地约为30-50号规格。术语微型针包含的非圆柱形结构从而可以为类似的结构并且可以包括锥形、矩形、八角形、楔形或者其它适当的几何形状。在授于Godshall等的美国5,879,326号专利、授予Lee等的美国5,250,023号专利以及WO 97/48440中公开这种器件的例子，这些文献的每一份的整个内容收录作为参考。另外，ID隔室指的是由从表皮下立即开始并延伸到网状真皮底的皮层构成的组织空间。该组织的平均厚度约为最外皮肤表面下0.05mm-0.15mm到1.7-2.5mm。业内人士会意识到根据每个人的和年龄、性别、身体位置、疾病状态和其它因素关联的生物可变性，皮肤隔室的绝对厚度和深度存在一定的可变性。在本文说明的例子中，用来进入该以及类似组织空间的器件的范围总深度可以从约0.3mm到3mm，＜2.5mm更好，并且对于ID传送最好深度＜1.7mm。
另外，传送系统204可以包括单针式，在一些应用中它是优选的。在这二种配置下，短期作用胰岛素类似物的ID传送产生快速发作和更高的生物药效率。即，依据本文所说明的本发明的各实施例实现的ID传送产生对注入的药物例如胰岛素的更迅速摄取。另外，和常规皮下治疗相比，真皮内胰岛素传送达到明显更快的治疗效果。
而且，针212中的一个或多个可以配置成是感测针电极。即，针阵列210的周边表面214可配置为是基准或控制电极并把一个或多个针212配置成感测电极，以向表示患者208体内的葡萄糖浓度的葡萄糖传感器系统206提供信号。在此方案下，每个感测针相对于传送针的位置和取向应使药物例如胰岛素的传送不会干扰感测针(组)准确地感测患者208体内分析物例如血葡萄糖的浓度的能力。葡萄糖传感器系统206感测患者208体内感兴趣的分析物的水平并且输出传感器信号。在本例中，可以向控制器202直接提供传感器信号，或者传感器信号在组合器216和基准信号组合或比较(例如，减去)然后再提供到控制器202。接着控制器202可以根据传感器信号相应地调节控制信号以便调节胰岛素传送系统204传送给患者208的胰岛素量。而且，一个或多个针212可配置成宿留传感器，或者换言之，能感测感兴趣的分析物的传感器可以连接到、植入到或者集成到一个或多个针212上。在单个器件中有效地集成感测功能和传送功能要求足够的空间分离，从而胰岛素给药不会影响局部葡萄糖浓度以使测量不会对估计系统葡萄糖浓度是不合适的。
这种系统200可在一个不妨碍用户正常活动的相对简单、容易使用的器件中包含控制算法。该控制系统200可以通过使患者历经整夜(最多)胰岛素响应检查进行参数初始化。胰岛素传送系统204可以包括一个能足以存储和传送至少一天的胰岛素的真皮内传送系统。上面讨论的葡萄糖传感器系统200可替代地植入以供长期连续使用，或者可以配置为是许多可以短期戴上的传感器中的一个。功率要求应是低的，从而会尽可能不频繁地更换电池。系统200还可以配置成允许控制器202、传感器系统210和传送系统204之间的无线通信，并且和患者208的通信可以通过控制器202(例如指示器，诸如系统200上的显示器)或者通过离线基站或个人计算机(PC)发生。系统200还可以配置成和康健提供商和/或非本地的系统管理者通信，例如通过电话(调制解调器或者无线)或者因特网。
另外，尽管上面讨论了一种类型的传感器，只有其具有足够的精度、准确性和适当短的响应时间，控制系统200内使用的传感器的类型可以是任何可用传感器中的一种。带有较长响应滞后的传感器可能是可接受的，因为所述材料的ID传送的快速PK/PD对控制周期内的感测操作提供更多的时间。在高葡萄糖值下精度下降的传感器也可能是可接受的，因为控制器200仍能操作成适当地控制胰岛素传送系统204以限制患者208体内高血糖的发作。
上面讨论的本发明的实施例基于真皮内胰岛素传送、PK/PD(药物动力学和药效学)以及现代控制理论的概念和原理。在系统200中使用造成快速发作的ID传送原理。工作中的基本控制原理是控制器202的采样率以及治疗发作/衰退率要比整个系统(患者和传感器)的动力学快。第二个和模型预测控制(MPC)相关的原理是，控制器202内包含的模型应含有关于患者对控制输入(例如，治疗)的响应的足够信息，而且因此效能快速发作下的治疗允许在该模型内含有更完整的信息。
图6示出图2中示出的系统200的一个例子，其进一步包括控制器202的模型预测控制器(MPC)构件218以及可提供到控制器202的输出。传感器系统206输出的传感器信号以及基准信号也提供到该控制器以允许如上面参照图1讨论那样计算控制命令。
如业内人士可理解的那样，基于模型的或者模型预测控制器(MPC)含有被控系统(患者及关联的传送和感测器件)的数学表达。控制器202根据患者208目前的状态以及患者208的未来期望行为(即，模型响应)生成控制命令(即，要传送的胰岛素速率或体积)。对每个进行的控制步骤，比较患者响应和模型响应，并且相应地调节控制命令。对MPC的优先要求是，嵌入的模型准确反应系统对控制输入的响应。在向糖尿病人传送胰岛素的情况下，该模型反映患者对胰岛素传送响应的葡萄糖分布。
取决于所使用的模型的类型，可以通过对患者的个性化检查或者通过施加对群体得到的参数(即，胰岛素灵敏度)生成模型响应。在系统200中，可以通过个性化检查，例如整夜胰岛素响应检查，构建模型。一个例举的但不排它的模型类型包括：基于生理式，经验式(隔室或移动平均或者自回归加移动平均)，基于数据式，神经网络，或者这些特征的组合。
如前面还讨论的那样，在基于生理的MPC的应用中，控制系统200采用胰岛素，尤其短期作用胰岛素类似物的ID传送。如后面会展示那样，仿真启示短期作用胰岛素在通过ID路径传送时比起常规或短期作用胰岛素的皮下SC施加或者常规胰岛素的ID会对糖尿病患者提供好得多的控制。采用短期作用胰岛素类似物的基于模型的控制允许更频繁地更新控制器202，从而允许更频率施加胰岛素、更准确的模型构建(因为相对于控制器的存储器尺寸以及计算要求胰岛素效能的时间跨度短)以及对于给定的模型和采样时间更逐渐地调谐控制器202(控制器202试图在更短的时段内使葡萄糖浓度回到基线值)。这造成更快地返回到额定基线(这会改进患者的健康)并且造成可改进传送的胰岛素的生物药效性的较小的瞬时胰岛素传送体积。此外，还实现可改善传送器件的可靠性和寿命的较小的胰岛素速率命令以及较小的速率命令变化，并且还通过使葡萄糖偏移以及低于任何阈值的时间为最小减少低血糖的发生，这会使患者的负面状态风险为最小。
模型218还可以使用数学模型，其可以生成和对人或猪传送ID胰岛素得到的曲线相匹配的胰岛素响应曲线。该建模过程基于药效学和药物动力学。该建模的一个例子利用现有生理模型生成动脉胰岛素响应曲线，这在上面引用的J.T.Sorensen的“A Physiologic Model ofGlncose Metabolism in Man and its Use to Design and AccessImproved Insulin Therapies for Diabetes”，PhD Thesis，M.I.T.，1985。该模型还能使从特定非动脉胰岛素(即，SC或ID)传送产生的动脉输入分布可视化。该信息接着可用于把SC或ID输入仿真到最适于接收动脉胰岛素输入的模型中。在图7中示出采样响应曲线。如指示那样，这些模型能复制猪胰岛素响应分布曲线。对于二种不同的传送方法，SC和ID，最好是二种不同的模型构建，并且每种模型中涉及的时间常数(t)是不同的。注意在该例中，使用一个带有一个暴露高度约在0mm到1mm之间的出口的小空心针。该开口按约0.3mm到约2mm之间的深度下插到皮肤中，从而在约0.3mm到约2mm的深度上发生胰岛素的传送。
如图7中显示那样，ID胰岛素传送提供“改进的药物动力学”，这意味着通过标准药物动力学参数，例如到达最大血浆浓度时间(Tmax)、最大血浆浓度幅值(Cmax)或者得到最小可检测血液或血浆浓度时间(Tlag)，测量达到药物动力学分布曲线的增强。对于增强的吸收分布曲线，通过利用这些药物动力学参数的测量吸收改进或者更大。技术上例行地进行药物动力学参数测量和确定最小有效浓度。通过和标准给药路径例如皮下给药或肌内给药相比，得到的值被认为是增强的。在这种比较中，尽管不必是必须的，真皮层内的给药以及对参照点的给药例如皮下给药最好涉及相同剂量水平，即，相同的药物量和浓度以及相同的载体和在单位时间的数量和体积上相同的给药速度。例如，100μg/mL浓度和5分钟的每分钟100μL的速度下给定药剂物质皮肤中的给药最好和相同100μg/mL和5分钟的每分钟100μL的速度下相同药剂物质的皮下空间给药比较。另外，如果所述物质对于真皮内传送具有20分钟的Tmax并且对于皮下传送具有60分钟的Tmax，则真皮内传送要比皮下传送增强了药物动力学分布。对于业内人士，对Cmax和Tlag的类似比较是明显的。作为进一步的例子，图7示出猪上通过皮下和真皮内方法传送的快速作用胰岛素(EliLilly Lispro)的药物动力学曲线。通过减小Tmax和Tlag和加大Cmax，真皮内胰岛素传送比皮下传送造成更迅速的胰岛素摄取。从而，真皮内传送改进胰岛素药物动力学。尽管真皮内传送典型地不影响体内生物清除率或机制，但和皮下传送相比其相对缩短全身的清除。从而，对于反馈控制系统，快速摄取(低Tmax，高Cmax)是有益的。在上面引用的已发布的国际专利申请WO 02/02179中进一步说明该效应。
还应注意，在例如图6中示出的连续控制回路系统中，可能需要在大的速率范围内连续地传送材料，仿真表明通过连续受控的胰岛素传送控制1型糖尿病人要求零到40-60毫单位(mU)/分(零到2.4-3.6U/小时)的传送速率。动物试验表明，对于防止不希望的低血糖反弹并且仍保持控制2U/小时是合理的传送上限(参见例如图14和15)。对于当前的胰岛素配方(每毫升液体100U(单位))，这些传送速率等于从零到约0.34微升/分或约20.4微升/小时(约2U/小时)。纯粹2型糖尿病人通常显示抗胰岛素或者不能利用胰岛素。从而这些患者可能需要更高的传送速率。实际上，大多数糖尿病患者显示一定程度的抗胰岛素，这增加胰岛素的要求。最多每分钟可传送1500微升的胰岛素溶液(10μL/U下150U/分)以满足抗性糖尿病患者对胰岛素的附加要求。
通过针，例如小规格真皮内(ID)针向皮肤组织传送液体可能要求传送系统建立足够的初始压力。需要该压力以克服组织内的阻力。一旦在传送的液体内形成该压力，液体会渗入组织空间。如果存在足够的压力，液体会继续流动。通过许多可买到的传送系统容易实现高流率情况，例如胰岛素块传送情况下克服回压的要求。但是，以前尚未解决在低的和可变的流率情况下克服该压力。
可以通过采用更稀释的药物配方得到益处。例如，在糖尿病猪的控制试验中已经使用稀释到20IU/ml(“20U”)的胰岛素。对于给定的剂量率，这种稀释表现为五倍增加液体体积。低剂量率下体积增加要求克服组织内的阻力所需的压力更高。
可以通过使用带有位于针尖适当距离处的孔或侧端口的针得到另一个好处。例如，可以利用带有1.0mm深处的侧端口的刺入皮肤1.5mm的34号针向ID空间传送胰岛素。该侧端口上的组织压力通常低于针尖处的压力，其部分的是因为针尖处的组织受到针插入动作的压缩。从而促使液体流入组织空间所要求的压力较小。
可以通过在适当的持续时间内提供短的高流率猝发并且它们间隔成在给定的时段内产生正确的液体体积传送等同地产生连续流率。采用高流率能在传送系统内产生较高的压力，从而克服上面讨论的组织回压。试验表明使用U20胰岛素下约4微升/分钟的流率并带有10分钟的传送间隔可以提供足够的控制并且保持进入ID组织的流动。甚至在总体积传送不超过10分钟内1微升下仍保持流动。市场上可买到的用来达到这些流率的泵的例子是Instech Solomon公司的Pegasus泵，其设计成在约20psi.下传送0.4ul的脉冲并且流速从0.01到15ml/小时或10到15000ul/小时或者0.2到250μL/分钟。
但是，产生短持续时间高流率脉冲在一些情况下必然产生小的总液体体积(例如，1微升)。如果传送系统凭借弹性或顺性能吸收该小的传送体积，则脉冲期间产生的高压波不会冲击组织从而不会发生传送。系统中的气泡是顺性的流，从而消除气阱形成的系统会具有传送小液体体积的优点。一种得到这样的系统的简单手段是提供针和传送管间的直接连接，即把管端直接粘结在针或针组上。还可以构建保持直径固定的液体通路并且消除可能形成气阱的“死区”的机械连接。能够在此方面上进一步提高性能的低顺性管在技术上是周知的。
对于试图保持高回压的药物传送系统，采用单针要比多针阵列有好处。对于传送大的液体体积多针阵列是有好处的，因为该方案在大的皮肤面积上分配该体积。单针有利于低体积/低流率/可变流率传送，因为系统的全部压力指向单个开口。
在控制回路环境下，还可能存在其中会要求中等流率(每小时几十微升)的情况。把这样的流率变换成脉冲式分布取决于对脉冲选择较高的速率可造成组织空间的短暂过载。为生成脉冲分布而选择的算法应考虑到组织的液体吸收率并且把脉冲构形(流率和持续时间)成保持一定的安全裕度。
还应注意闭环控制系统只是其中必须在长的时段内提供可能从零变化到每小时几十微升的连续流率的情况中的一种例子。治疗学上的业内人士可以预期其它可以利用连续低速率传送的药物治疗。
图8的曲线说明在餐中和餐后控制糖尿病患者模型的一个例子。该患者模型开始58分钟50克的强加进餐。控制器202(图2)命令向患者208皮下(SC)或真皮内(ID)传送Lispro。传感器具有1分钟的内部延迟并且1阶时间常数为1分钟。在该例中，该控制器具有5分钟的采样间隔，出错加权为3，输出移动加权为1，模型系数数量为40，移动水平线为2并且预测水平线为2。该进餐是根据Lehman和Deutsch(1992)的标准进餐。
图9的曲线说明一个控制糖尿病患者三餐模型的例子。该患者模型强制受到50、75和50克的三餐。控制器202命令向患者208皮下(SC)或真皮内(ID)传送Lispro。传感器具有1分钟的内部延迟并且1阶时间常数为1分钟。在该例中，控制器202具有10分钟的采样间隔，出错加权为3，输出移动加权为1，模型系数数量为40，移动水平线为2并且预测水平线为2。这些进餐基于Lehman和Deutsch(1992)的标准进餐。
图10的曲线说明在餐中和餐后控制糖尿病患者模型的一个例子。该患者模型开始58分钟50克的进餐。控制器202命令对患者208皮下(SC)或真皮内(ID)传送Lispro。在这二种情况下，对传感器输出添加30分钟的延迟以模拟皮下葡萄糖测量。传感器具有1分钟的内部一阶时间常数。在该例中，该控制器具有5分钟的采样间隔，出错加权为3，输入移动加权为1，模型系数数量为40，移动水平线为2并且预测水平为2。该进餐基于Lehman和Deutsch(1992)的标准进餐。
图11的曲线说明对糖尿病患者控制三餐的一个例子。对该患者模型施加50、75和50克的进餐。控制器202命令对患者208皮下(SC)或真皮内(ID)传送Lispro。在这二种情况下，对传感器输出添加30分钟的延迟以模拟皮下葡萄糖测量。传感器具有1分钟的内部一阶时间常数。在该例中，控制器202具有10分钟的采样间隔，出错加权为3，输出移动加权为1，模型系数数量为40，移动水平线为2并且预测水平线为2。这些进餐基于Lehman和Deutsch(1992)的标准用餐。
图12的曲线说明模型能复制人对胰岛素的响应曲线。为对ID传送建模，最好有三条并行的传送路径。
图13的表示出尤其可由图6中示出的系统实现的闭环治疗的例子。此外，上面说明的所有系统还允许估计未明确测量的身体部分的某物质例如葡萄糖的浓度，例如根据间质液体葡萄糖测量估计动脉葡萄糖(这种实现技术上称为“状态估计”)。
如可从上面理解那样，控制周期应足够快以提供有效的生理控制。这样，生理测量的速度和频率以及治疗影响生理的快速性对于控制是重要的。例如，在中等采样频率下，模型式控制系统中的皮下测量和传送的结合显示性能下降。但是，上面说明的这些实施例通过采用ID传送可以克服这种系统的低效并且能实现稳定控制。即使在模型系统中不包含皮下测量的限制，上面说明的实施例能实现更稳定的控制和更高的性能。
如可从上面进一步理解那样，本发明的实施例可以利用闭环系统，尤其采用基于模型的控制(MBC)并且更加尤其采用模型预测控制(MPC)算法，启动并且提供对糖尿病患者的连续胰岛素治疗。MPC算法按规定的时间间隔评估当前和过去的葡萄糖水平以及目前的胰岛素传送史以便计算会把患者降到目标葡萄糖水平的胰岛素剂量。该剂量的计算考虑患者的对胰岛素的药物动力学(PD)响应的模型以及期望的未来葡萄糖目标。本发明的实施例利用MPC算法能在患者的血葡萄糖任意偏离目标并且使发生低血糖最少下启动控制器(例如图6中示出的控制器202)的方式设定未来的葡萄糖目标。更具体地，MPC算法把目标分布设定成包括一个目标从当前葡萄糖值改变到期望目标值的阶段。在从目前值过渡到期望的葡萄糖值期间目标值的改变率是固定(即，该分布包括斜坡曲线)，但是该改变率也可以随时间变化。可以利用带有时变目标值的目标分布启动控制、从中断操作阶段或在过度葡萄糖偏移后恢复。目标值的变化率取决于患者的PK特性。
可以最优地把用于目标斜坡的数据写到控制器公式中，从而整个斜坡包含在该控制器公式中。这样，该控制器不仅具有关于当前时刻的目标浓度值的信息，并且具有关于要预测的整个未来时段(技术上该时间称为“预测水平线”)的目标浓度值的信息。从而该控制器可以计算使该预测水平线内所有时段中预测和目标浓度之间的差为最小的治疗剂量。可以利用和在确定用来建立控制器的模型中使用的相同的患者PD数据优化斜坡持续时间设定。
可以通过斜坡式目标技术和其它技术的比较理解采用依据本发明的一实施例的斜坡式目标得到的好处。一种替代的操作方式是在每个计算间隔上设定新的平直的目标值。例如如果采用设计成不考虑未来的目标值的比例积分微分(PID)控制器，这会是唯一的选择。在MPC中，在考虑预测的患者响应并且可能未来的胰岛素剂量的情况下计算当前的胰岛素剂量。如果在任何计算间隔上未来目标值是“平的”，算出的目前和未来的剂量会和如果未来的目标值是斜坡式的情况下算出的剂量不同。这种不同可能导致和利用斜坡目标相同接近目标较慢。
另一种替代会是启动控制时逐渐改变胰岛素传送的允许速率。当前血葡萄糖值和目标值之间的大差异通常会使控制器(例如，MPC或经典控制器)产生高速率胰岛素传送命令以便快速地达到目标。斜坡式目标产生较小的初始传送率命令。还可以把控制器206指令成或编程成把胰岛素传送限制在任意最大值上。在控制器启动时如果把该最大传送率设成预期会保持葡萄糖目标的基础速率(或者甚至更低的速率)，则会同样产生低的初始速率。接着可以逐渐地随着时间把该限制倾斜到最终值上。正确选择传送限制可以和斜坡目标技术一样或类似地逼近目标值，但是不会显式地利用控制器的优化能力。
可以从图14和15描述的图进一步理解斜坡目标技术的好处。具体地，图14示出利用固定的葡萄糖目标启动控制。数据来自糖尿病猪的控制实验。通过1.0mm34号针传送Lispro U100。在该例中按160mg/dl的目标值启动控制器(例如，控制器206)。初始葡萄糖值是246mg/dl。控制器206产生最高的传送允许速率，在本情况下这造成低血糖发作。
图15示出利用斜坡葡萄糖目标启动控制。数据来自糖尿病猪的控制实验。通过三个1.5mm34号注入针组传送Lispro U100。在等于初始葡萄糖值209mg/dl的目标下启动控制器(例如，控制器206)。在二小时下目标倾斜到160mg/dl。该控制器产生中等传送速率，这造成对最终目标的平滑逼近。
上面讨论的本发明的实施例的一种替代用途是限制餐后的潜在低血糖。由于餐后葡萄糖水平急剧上升，控制器(例如控制器206)会通过提高胰岛素传送作出响应。“朴素”控制器会最终把平均葡萄糖水平保持在目标值上，从而任何高血糖会跟着一段低血糖。通过如上面讨论那样限制胰岛素传送的最大速率可以大大减少该效应。还可以通过把目标值重新设为高血糖发作期间达到的葡萄糖水平或附近达到低血糖的减少。这会使控制器206明显降低胰岛素传送率，从而避免形成低血糖。例如可以通过分析当前的葡萄糖浓度数据确定对目标的重新设定。可以通过分析患者对胰岛素的PD响应确定能回到最终目标(“正常血糖”)的新目标和时间。在产生控制器206内的原始内部模型中应使用通过该相同的PD信息。
尽管上面只详细说明本发明的一些示范实施例，业内人士容易理解在不实质上背离本发明的新颖讲授和优点下对这些示范实施例的许多修改是可能的。从而，所有这样的修改是包含在由下面的权利要求书定义的本发明的范围之内的。

Claims (51)

1.一种用于控制患者体内一种物质的浓度的系统，该系统包括：
一个传送器件，其适于真皮内地向患者传送一种材料以造成快速摄取所述材料和快速清除所述材料中的至少之一；以及
一个控制器，其适于确定患者体内的响应于对该患者传送的所述材料而出现的所述物质的浓度，并且提供适用于控制该传送器件的输出以便根据所述物质的浓度控制对该患者传送的所述材料的量。
2.根据权利要求1的系统，其中：
所述控制器适于向所述传送器件提供所述输出以便自动地控制该传送器件。
3.根据权利要求1的系统，其中：
所述控制器提供所述输出作为可读的和所述物质的浓度相关的信息，以供手动调整所述传送部件从而把适当量的材料注入到患者体内。
4.根据权利要求1的系统，其中：
所述材料包括胰岛素并且所述物质包括葡萄糖。
5.根据权利要求4的系统，其中：
所述胰岛素包括短期作用胰岛素。
6.根据权利要求1的系统，其中：
所述材料和所述物质是相同的。
7.根据权利要求1的系统，其中：
所述传送器件包括适于真皮内地向患者传送所述材料的单针阵列或者多针阵列。
8.根据权利要求1的系统，还包括：
一个传感器，其适于检测患者体内所述物质的所述浓度和向所述控制器提供指示该浓度的信号，所述控制器适于分析所述信号以便确定患者体内所述物质的浓度。
9.根据权利要求8的系统，其中：
所述传感器适于检测所述患者某位置上的所述物质的所述浓度，并且所述控制器适于分析所述信号以便估计患者体内和所述传感器检测所述浓度的位置不同的另一位置上的所述物质的所述浓度。
10.根据权利要求1的系统，还包括：
一个适于对所述系统供能的自备电源。
11.根据权利要求1的系统，还包括：
一个适于存储作为向所述患者传送的所述材料的胰岛素的胰岛素存储器件。
12.根据权利要求1的系统，其中所述系统是便携式的和患者可戴上的。
13.根据权利要求1的系统，其中所述控制器和所述传送器件之间的至少一部分通信包括无线通信。
14.根据权利要求8的系统，其中所述控制器、所述传感器和所述传送器件之间的至少一部分通信包括无线通信。
15.根据权利要求1的系统，其中所述控制器适于和该系统外的一个器件通信以在该控制器和患者及康健提供商中的至少一个之间中继信息。
16.根据权利要求1的系统，其中所述控制器使用包括基于生理的模型的控制模型。
17.根据权利要求1的系统，其中所述控制器使用包括基于数据的经验模型的控制模型。
18.根据权利要求1的系统，其中：
所述材料包括胰岛素并且所述物质包括葡萄糖；以及
所述控制器使用一个算法，以使所述胰岛素的所述传送前存在的所述葡萄糖的传送前浓度和目标或预测葡萄糖浓度比较、使所述胰岛素的所述传送后存在的所述葡萄糖的传送后浓度和目标或预测葡萄糖浓度比较，并且根据这些比较确定恰当的胰岛素剂量。
19.根据权利要求18的系统，其中：
所述控制器使用包括基于生理的模型的控制模型，并且所述控制器根据所述传送后的葡萄糖浓度和所述目标或预测葡萄糖浓度的比较来调整所述模型。
20.根据权利要求18的系统，其中：
所述控制器使用包括基于数据(经验)的模型的控制模型，并且所述控制器根据所述传送后的葡萄糖浓度和所述目标或预测葡萄糖浓度的比较来调整所述模型。
21.根据权利要求1的系统，其中：
所述快速摄取受所述材料的PK/PD(药物动力学和药效学)效应的影响。
22.一种控制患者体内一种物质的浓度的方法，该方法包括：
向患者真皮内地传送一种材料以造成快速摄取所述材料和快速清除所述材料中的至少之一；以及
确定响应于对该患者传送所述材料而在患者体内出现的所述物质的浓度；以及
提供一个输出，该输出适用于根据所述物质的浓度控制对该患者传送的所述材料的量。
23.根据权利要求22的方法，其中：
所述提供步骤向一传送器件提供所述输出以便自动地控制该传送部件从而控制对患者传送的所述材料的所述量。
24.根据权利要求22的方法，其中：
所述提供步骤提供所述输出作为可读的和所述物质的浓度相关的信息，以供手动调整传送器件从而使适当量的所述材料注入到患者体内。
25.根据权利要求22的方法，其中：
所述材料包括胰岛素并且所述物质包括葡萄糖。
26.根据权利要求25的方法，其中：
所述胰岛素包括短期作用胰岛素。
27.根据权利要求22的方法，其中：
所述材料和所述物质相同。
28.根据权利要求22的方法，其中：
所述传送步骤包括操作包含单针或多针阵列的传送器件以便真皮内地对患者传送所述材料。
29.根据权利要求22的方法，还包括：
感测患者体内所述物质的所述浓度并提供指示该浓度的信号，所述信号在所述确定步骤中使用，以便分析所述信号并从而确定患者体内所述物质的浓度。
30.根据权利要求29的方法，其中：
所述感测步骤感测所述患者体内某位置上的所述物质的所述浓度，并且所述确定步骤分析所述信号以估计患者体内和所述感测步骤检测所述浓度的位置不同的另一位置上的所述物质的所述浓度。
31.根据权利要求22的方法，还包括：
对系统供能以利用自备电源执行所述传送、确定和提供步骤。
32.根据权利要求22的方法，还包括：
存储胰岛素作为传送到所述患者的所述材料。
33.根据权利要求22的方法，其中：
通过便携的并且患者可戴上的系统执行所述传送、确定和提供步骤。
34.根据权利要求22的方法，还包括：
在执行所述传送步骤的传送器件和执行所述确定及提供步骤的控制器之间无线地通信。
35.根据权利要求22的方法，还包括：
在执行所述传送步骤的传送器件、执行所述确定及提供步骤的控制器以及执行所述感测步骤的传感器之间无线地通信。
36.根据权利要求22的方法，还包括：
和执行所述传送、确定和提供步骤的系统外部的一个器件通信，以在该系统和患者及康健提供商中至少之一之间中继信息。
37.根据权利要求22的方法，其中所述确定步骤使用包括基于生理的模型的控制模型。
38.根据权利要求22的方法，其中：
所述材料包括胰岛素并且所述物质包括葡萄糖；以及
所述确定步骤使用一个算法，以使所述胰岛素的所述传送前存在的所述葡萄糖的传送前浓度和目标或预测葡萄糖浓度比较、使所述胰岛素的所述传送后存在的所述葡萄糖的传送后浓度和目标或预测葡萄糖浓度比较，并且根据这些比较确定恰当的胰岛素剂量。
39.根据权利要求38的方法，其中：
所述确定步骤使用包括基于生理的模型的控制模型，并且所述控制器根据所述传送后的葡萄糖浓度和所述目标或预测葡萄糖浓度的比较调整所述模型。
40.根据权利要求38的方法，其中：
所述确定步骤使用包括基于数据(经验)的模型的控制模型，并且所述控制器根据所述传送后的葡萄糖浓度和所述目标或预测葡萄糖浓度的比较调整所述模型。
41.根据权利要求22的方法，其中：
所述快速摄取受所述材料的PK/PD(药物动力学和药效学)效应的影响。
42.一种用于调整患者体内某物质的浓度的系统，该系统包括：
一个控制器，其适于提供代表目标浓度的分布的信息；以及
一个传送器件，其适于在该控制器的控制下向患者真皮内地传送一种材料以便实质上根据该分布把该物质的浓度调整到该目标浓度。
43.根据权利要求42所述的系统，其中：
该物质是血葡萄糖并且该材料包括胰岛素。
44.根据权利要求42所述的系统，其中：
该分布包括随时间变化的多个目标浓度。
45.根据权利要求42所述的系统，其中：
该分布可用斜率非零的线表示。
46.根据权利要求42所述的系统，其中：
该传送器件包括单针或多针阵列。
47.一种用于调整患者体内一种物质的浓度的方法，该方法包括：
提供代表目标浓度分布的信息；以及
在控制器的控制下向患者真皮内地传送一种材料以便实质上根据该分布把该物质的浓度调整到该目标浓度。
48.根据权利要求47所述的方法，其中：
该物质是血葡萄糖并且该材料包括胰岛素。
49.根据权利要求47所述的方法，其中：
该分布包括随时间变化的多个目标浓度。
50.根据权利要求47所述的方法，其中：
该分布可用斜率非零的线表示。
51.根据权利要求47所述的方法，其中：
该传送步骤包括使用一个具有单针或多针阵列的传送器件以传送该材料。
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US20040152622A1 (en) 2004-08-05
EP1575656B1 (en) 2009-06-17
US7060059B2 (en) 2006-06-13
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