CN102576385A - 具有自适应控制的电解药物输送泵 - Google Patents
具有自适应控制的电解药物输送泵 Download PDFInfo
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- CN102576385A CN102576385A CN2010800469118A CN201080046911A CN102576385A CN 102576385 A CN102576385 A CN 102576385A CN 2010800469118 A CN2010800469118 A CN 2010800469118A CN 201080046911 A CN201080046911 A CN 201080046911A CN 102576385 A CN102576385 A CN 102576385A
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Abstract
基于泵状况的变化控制药物输送泵的致动。
Description
相关申请的交叉引用
本发明要求2009年8月18日提交的美国临时专利申请No.61/234,742的优先权和权益,通过引用把其全部内容合并于此。
技术领域
在各个实施例中,本发明涉及药物输送泵。特别地,本发明的实施例涉及药物输送泵,该药物输送泵的致动可为动态且自适应控制的。
背景技术
药物治疗通常需要把治疗剂(例如药剂、药物等)给药至患者身体的特定部位。随着患者寿命延长并被诊断出患有慢性病和/或无力症,可能的结果将是更需要把更多蛋白药品、小分子药物和其他药剂置入遍及患者整个身体中的靶区。然而,一些疾病难以用当前可用的疗法治疗和/或需要把药物给药至难以触及的解剖区域。
患者眼睛是难以触及的解剖区域的最好例子,而且,许多危及视力的疾病难以用目前存在的许多疗法治疗,这些疾病包括色素性视网膜炎、老年性黄斑病变(AMD)、糖尿病视网膜病变和青光眼。例如,口服药物会具有***性副作用;局部用药会引起刺痛并引起病人不良适应性;注射通常需要去医院,而且会引起痛苦,并有感染的风险;以及,持续释放药物的植入物在药物耗尽后必须取出来(以及通常,适应临床症状而改变剂量的能力有限)。
另一个例子是癌症,诸如乳腺癌或者脑膜瘤,其通常通过静脉注射向患者给药大剂量的高毒性化学治疗药物,如雷帕霉素、贝伐单抗(例如AVASTIN)或者伊立替康(CPT-11),这会致使在靶区以外出现很多不期望的副作用。还一个例子是药物输送至膝盖,在膝盖处,药物难以穿过无血管的软骨组织来治疗如骨关节炎的疾病。
可植入药物输送装置(例如,药物输送泵)通常允许把药品溶液有控制地输送到指定靶区,该可植入药物输送装置可以具有可重复填充的药物储存器、用于输送药物的插管、止回阀等。当药物储存器中的药物耗尽时,医生能够用例如注射器重新填充储存器而保留抑制在患者体内的装置。这种方法可以使植入所需的外科切口最小,通常避免了以后或重复性的介入性外科手术或过程。
可植入药物输送泵,特别是在眼科应用中,通常利用被动药物输送机制(例如,在手指按在药物储存器上时把药物泵出)。这些传统的、被动驱动的药物输送泵的一个局限在于它们不能动态地响应泵内的变化(例如,故障、阻塞等)或响应药物输送靶区内的变化(例如,增高的压力、泵插管的挠度、引起插管周围压力的炎症等)。具备能够响应这些变化的能力不仅能够改善泵的治疗价值,而且改善了安全性。
主动药物输送泵,特别是反馈驱动泵,代表了超越被动驱动泵的实质性改进。通常,这些反馈驱动泵是电动机械泵。它们通常使用控制器单元,其接收来自监测目标治疗区的传感器的输入,以及作为响应,引导药物或治疗剂的释放以实现期望的结果。因此在每个剂量周期内释放的药物量主要由靶区的现状决定,并确定为依据靶区状况的许可可变。
然而,药物治疗方案可能需要药物在固定时间间隔以固定量给药而不管药物输送靶区的变化条件。由于通过现有闭环反馈驱动***产生的剂量水平高度依赖于治疗区域的参数并因此容易波动,它们不足以在周期性间隔上输送固定的药物剂量。例如,靶区的状况变化,诸如阻塞或其他的生化或生理事件,会导致输送至靶区的可变水平的药物。因此,有维持目标剂量水平而不管这些变化的反馈驱动泵的需求。
此外,虽然基于靶区状况的反馈在许多治疗应用中是重要的,而在药物给药中的失误也会由泵自身内的状况变化引起。传统的泵通常不考虑这些变化,这同样会导致可变的释放药物量。因此,同样有动态响应泵自身内的状况变化的药物输送***的需求,以例如在周期性时间间隔上连续地释放固定的药物剂量。
发明内容
在各个实施例中,本发明的特征是外用的或可植入的药物输送泵,其包括动态、自适应控制***。该控制***可操作该泵以使得在固定时间间隔上基本将固定量的药物或治疗剂释放至目标治疗区域。在某些实施例中,控制***持续地监测(直接或间接地)泵内部的状况,其对泵激励的程度和持续时间有影响,并因此影响释放药物量。如这里所使用的,术语“基本”指的是±10%(例如,按重量或体积),以及某些实施例中为±5%。
在一个实施例中,药物输送泵是电化学激励泵,如电解驱动泵。对比于电动机械泵,电化学激励泵提供了针对药物输送***的多个优势。例如,它们通常少有活动部件,这使得它们小且便携,以及这使得它们比电动机械泵不易发生机械故障。特别地是,电化学激励泵适合于需要小的泵尺寸的环境,诸如眼科环境。如这里进一步描述,电解驱动泵通常使用电极以产生电化学活性气体,其可变地加压包含于隔离腔中的药物从而以可控制方式分配药物。分配的药物量取决于由泵致动器可变产生的气体压力,而这又依赖于经过电极的电流。由于这些电解驱动泵内的内在可变性(例如,气体体积和/或电解质的量会在每个泵循环之间变化),这里描述的自适应控制设计能够具有重要的优势,这将在下文进一步说明。
一般而言,在一个方面,本发明的实施例的特征在于药物输送泵,其包括药物储存器、用于从储存器引导液体至目标位置的插管、用于推动来自储存器的液体穿过插管的泵致动器、以及用于控制致动器的电路。特别地,该电路控制致动器以i)初始地输送随时间(例如,在周期性时间间隔上或通过连续注射)基本固定的液体剂量至目标部位,和ii)补偿泵的状况变化以维持或恢复随时间(例如,在周期性时间间隔上或通过连续注射)基本固定的液体剂量至目标部位的输送。
一般而言,在另一方面,本发明的实施例的特征在于一种将从药物输送泵输送药物至患者的方法,该药物输送泵包括药物储存器和泵致动器,该致动器用于推动液体从储存器进入患者体内。该方法包括建立药物储存器和患者(即,目标部位)之间的流体连通,以及包括控制泵致动器。特别地是,控制该致动器以i)初始地从药物储存器输送随时间(例如,在周期性时间间隔上或通过连续注射)基本固定的液体剂量至患者,和ii)补偿泵的状况变化以维持或恢复随时间(例如,在周期性时间间隔上或通过连续注射)基本固定的液体剂量至患者的输送。
在各个实施例中,控制电路包括存储器,其用于存储在先前输送事件时候(例如,每个输送时间间隔时候)的泵的状况。此外,药物输送泵还包括流量传感器,用于测量通过插管并进入患者的流体流速,以及电路可以至少部分地基于流速分析控制泵致动器。电路还可以基于已存储的先前剂量时的泵的状况和/或致动器的实时数据控制致动器。
如前所述,药物输送泵可以是电解驱动泵。更特别地,泵致动器可以包括电解腔、隔开电解腔和药物储存器并提供了它们之间流体屏障的可膨胀隔膜、以及引起在电解腔内放出气体的电解电极。气体的放出扩张了隔膜从而推动流体从药物储存器进入插管。在各个实施例中,通过改变供给电极的激励电流来调节隔膜的膨胀。在其他实施例中,通过改变电极的激励持续时间来调节隔膜的膨胀。如这里所描述的,可通过恒定电流或时变电流波形驱动电解电极。
一般而言,在还一方面,本发明的实施例的特征在于药物输送泵,其包括药物储存器、电解腔、电解电极、隔开电解腔和药物储存器并提供了它们之间流体屏障的可膨胀隔膜、用于从药物储存器引导流体至目标部位的插管、以及基于目标部位的状况(例如,目标部位上一个或多个生化参数的变化、目标部位上的电活性的变化、和/或目标部位上压力的变化)用于调节隔膜扩张的电路。该泵还包括传感器用于探测这些状况。对它们来说,可以激励电解电极以引起气体在电解腔内放出,这使得隔膜扩张从而推动流体从药物储存器进入插管。
通过参考下面的说明书、附图以及权利要求会使这里公开的本发明的这些及其他目的以及益处和特征更加显而易见。此外,应该理解,即使在这里没有明确,这里所述的各个实施例的特征不是互斥的,而是可以各种组合和互换存在。
附图说明
附图中,相似的参考数字通常指不同视图中的相同部件。以及,附图不必是按比例的,而重点通常在于说明本发明的原理。在下面说明中,参考下面附图描述本发明的各个实施例,其中
图1示意性地以截面视图示出了根据本发明的一个实施例的可植入药物输送泵;
图2示意性地以截面视图示出了根据本发明的另一个实施例的可植入药物输送泵;
图3是根据本发明的一个实施例的药物输送泵的框图;
图4是表示如何使图1-3所描述的每个药物输送泵适应泵内的变化状况从而输送目标剂量水平的示例;
图5A示出了没有反馈控制操作的泵的示例性流量和激励曲线图;
图5B示出了随着泵的效率降低在一个更长的时期激励泵致动器的泵的示例性流量和激励曲线图;
图5C示出了随着泵的效率降低增加泵的激励电流的泵的示例性流量和激励曲线图;
图6是患者眼睛截面图,其示意了根据本发明的一个实施例的药物输送泵植入患者眼睛中。
具体实施方式
总地来说,本发明的实施例是关于外用或可植入的药物输送泵(不管它们是否是可重复使用以及可重新填充的泵、一次性泵等),该药物输送泵的致动是动态且自适应控制的。例如,实施例的药物输送泵可以是可植入患者体内的,如患者眼中或脑中。在某些实施例中,可植入药物输送泵结合了小尺寸且可重新填充的药物储存器。该小尺寸最小化了药物输送泵对患者的不适感,而该重新填充储存器允许泵在原处重新填充而不用替换。这样,液体,如药物溶剂,能够在一段较长时间内供给至患者。
A.示例性药物输送泵
本发明的实施例可结合各种类型的药物输送泵来使用,而不管它们是否是外用泵或可植入患者体内的泵。图1和2示意性地说明了植入患者眼睛104中的示例性可植入药物输送泵100(即,示例性电解或电解驱动泵100)的两个变型。然而泵100可以替换为植入患者身体的其他部位中。例如,它可以植入到大脑的蛛网膜下腔空间以向大脑提供化学治疗或提供另一种类型的治疗(例如,通过对直接对大脑软组织给药);植入到患者身体任何部位处的肿瘤附近以提供化学治疗;植入到对葡萄糖代谢不好的胰腺中以提供触发胰岛素释放的药剂(例如蛋白质、病毒载体等);在患者体外而使插管置于皮下或腹腔中以输送胰岛素;植入膝盖中以提供治疗骨关节炎或其他软骨疾病的药物;植入到靠近脊柱以提供止痛药或消炎药;或植入到其他地方。
如图1和2所示,泵100的实施例包括两个主要组件:一对腔108、112,其至少部分地由壁115包绕;以及插管120。如图1所示,包绕腔108、112的壁115包括或由以下组成:独立的聚对二甲苯薄膜116;以及在其之上的隔离保护壳128,其由相对刚性的生物相容性材料(例如,医学级的聚丙烯)制成。可替代地,如图2所示,壁115可仅仅对应于保护壳128,其涂敷有聚对二甲苯。
上腔108限定了药物储存器,其在用于治疗患者时可以含有以液体形式给药的药物。对于下腔112来说,下腔112包括液体,其在该液体被电解时,产生气态产物。例如,该液体可以是水,其可由所施加电压电解分离为氢气和氧气。可替代地,作为其他示例,该电解液可以是盐溶液(即,H2O中的NaCl)或者是含有硫酸镁或硫酸钠的溶液。在一个实施例中,两个腔108、112由褶皱隔膜124隔开。换言之,隔膜124提供了两个腔108、112之间的流体屏障。类似于独立薄膜116,隔膜124可由例如聚对二甲苯构成。如图1所示,独立薄膜116作为对药物储存器108的外部屏障,保护壳128提供了抵住薄膜116施力的硬表面。在这种情况下,外壳128带有孔以允许眼睛、大脑或其他体液流动。可替代地,如图2所示,保护壳128可以自身作为针对药物储存器108的外部屏障,且无孔。在图1和2所描述的两个实施例中,保护壳128能够阻止施加在药物储存器108上的外部压力。如图1所示,保护壳128的底部126(即,底板126)可以包括缝合孔130。类似的,尽管未在图1或2中示出,插管120也可以沿其侧面包括缝合孔。缝合孔130可用来在患者体内将泵100缝合(即,锚固)在适当位置。
同样如图1所示,为了给泵100供能并能在其间进行数据传送,可在腔108、112下(即,介于药物储存器108的独立聚对二甲苯薄膜116的底部和保护壳128的底板126之间)(例如,密封地)嵌入电池和控制电路132,并且把感应线圈136集成在保护壳128内(例如,通过注入成型)。图2更清楚的示意了用于容纳电池和常规控制电路132的密封外罩135,但为了简化起见,没有描述容纳于其中的组件。密封外罩135由生物相容性材料(例如,钛)或金属合金制成。密封外罩135的底部是平的,或者可以是凹面的以帮助可植入泵100安装在患者眼睛104上。
在一个实施例中,感应线圈136允许与外部装置(例如,手持机)无线(例如,射频)通信。手持机可以用来发送无线信号至控制电路132以编程、重新编程、操作、校准或者是配置泵100的其他操作。在一个实施例中,控制电路132通过跨越电解储存器112底部的金属互连件(通路)138与电解腔112内的电解电极134电通信。电解电极134可由例如铂、金、和/或其他金属制成。如下文进一步描述的,控制电路132控制泵100的抽吸作用,其包括下文描述的闭环控制过程。
在一个实施例中,如图1所示,插管120将药物储存器108连接到插在给药部位的止回阀140。止回阀140可以是单向止回阀,其阻止任何液体回流进入药物储存器108。可替代的,或另外的,如图2所示,止回阀140可以集成并定位在插管120的近端(即,处于最接近药物储存器108的一端)。然而,更一般而言,止回阀140可以定位在沿插管120的任何位置。此外,一个或多个用于监测药物流量、以及进而能够测量通过插管120的已输送药物体积和/或药物流速的流量传感器144可以结合在插管120的近端、中间或远端部分中的一个或多个。任选的,如图1所示,一个或多个目标部位传感器148也可以集成在插管120的远端(即,在离药物储存器108最远的一端)以测量给药部位(例如,玻璃体腔、肩关节囊、膝关节囊、脑室、椎管等)上的一个或多个参数。例如,可利用目标部位传感器148来感测目标部位处生物或生化参数的变化(例如,特定分析物浓度的变化、存在或不存在特定生化标记,等)、目标部位处电活动的变化(其可以例如由生理变化而引起)、以及目标部位处压力的变化中的一个或多个。在一个实施例中,目标部位传感器148提供反馈(即,实时测量)至控制电路132从而通过闭环控制过程测量药物流量。例如,药物靶区内增大的压力可以证明来自泵100的药物流量的减少。
如图1所示,插管120可以是独立聚对二甲苯薄膜116的延伸。可替代的,如图2所示,插管120可以是连接至保护壳128的独立组件(例如,聚对二甲苯组件)。例如,可以穿过形成在保护壳128中的流体连通口***插管120的近端,并通过例如生物相容性环氧树脂胶150与之粘结。硅树脂套154可以围绕插管120的一部分设置(参加图2),但这是可选的(参见图1)。
在一个实施例中,如图1所示,药物储存器108装配有填充口152且该填充口由密封剂(例如,生物相容性环氧树脂)156密封至独立薄膜116和保护壳128。在又一实施例中,如图2所示,可以形成通过保护壳128的孔,并把填充口152置于孔中。在另一个实施例中,填充口152可形成在泵100上其他位置处并通过管子连接到药物储存器108。例如,填充口152可以用生物相容性材料模制而成,耦合到密封罩135上的配合凹口上,并通过管子连接到药物储存器108。在一个实施例中,管子通过在围绕药物储存器108的壁上形成的流体连通口***,并通过生物相容性环氧树脂胶与之粘结。在任一种情况下,填充口152和药物储存器108流体连通,并允许泵100的操作者(例如医生)在原处(例如,在泵100植入在患者眼睛104中时)重新填充药物储存器108。一般来说,可以通过把再填充针***并穿过填充口152而重新填充药物储存器108。
在各个实施例中,泵100的主要部件(即,一对腔108、112和插管120)可采用多层聚对二甲苯工艺进行单片微加工和集成。可在微加工步骤之后,为泵100装配填充口152、保护壳128以及其他组件。
工作时,当向电解电极134提供电流时,电解质产生气体,使褶皱隔膜124膨胀(即,在图1和2中向上方移动隔膜124),并迫使液体(例如,药物)流出药物储存器108进入和通过插管120,并流出其远端以到达给药的目标部位。可膨胀隔膜124中的褶皱或其他折叠允许大程度的膨胀,而不会在隔膜124松弛时牺牲药物储存器108内的容积。当停止电流时,电解气体凝结回液态,并且隔膜124恢复到其节省空间的褶皱状态。
B.基于内部泵的状况的自适应控制
一般而言,电解驱动泵100对提供给电解电极134的给定输入电流的响应依赖于药物储存器108内剩余的液体量。例如,如果药物储存器108接近排空,在开始增加压力和起动抽吸作用前需要更多的电流以引起药物储存器108至其“充满”配置。另一方面,如果药物储存器108完全充满,在药物输送开始前只需要非常小的电流。类似的,电解驱动泵100对给定输入电流的响应还依赖于电解腔112内的气/液比。特别地,药物储存器108充满药物时(例如,当电解腔112以低气/液比工作时)与药物储存器108接近排空时(例如,当电解腔112以高气/液比工作时)相比,泵100的响应将会非常不同。此外,其他因素能够引起电解驱动泵100的响应以随时间变化,这些其他因素包括,例如,电解电极134的降解、电解腔112内电解质浓度的变化、止回阀140的流动特性的变化、以及由于组织生长或一些其他机制而在插管120出口处形成的限制。
由于这些因素,电解泵100是内在可变的。因此,根据该变化的自适应控制能够使泵100具有很大的优势。例如,如下文进一步说明的,通过分析先前剂量来确定泵100如何响应给定输入电流,能够获得针对当前剂量的最佳设置(例如,提供最精确和最少剂量的设置)。这在剂量体积相比于药物储存器108的容积较小时显得特别有利。在这种情况下,泵100的状态参数(例如,药物储存器108中剩余的药物体积、电解腔112内的液/气比、电极134的状况、止回阀140的特性等)从一个剂量到紧接下来的剂量是几乎相同的,因此,先前剂量是对当前剂量的极好预测。
图3是药物输送泵200的框图,其更加详细地描述了控制电路132。药物输送泵200可以是任何类型的外用或内用泵,其具有推动液体从药物储存器108进入并通过插管120的致动器204。例如,药物输送泵200可以是电解驱动泵,并参照上述图1和2所描述的,泵致动器204可以包括电解腔112、可膨胀隔膜124、以及电解电极134。对于控制电路132来说,控制电路132包括计算机存储器208,用于存储泵200的一个或多个状况;以及自适应控制器212,用于基于泵200状况的变化控制泵致动器204。可选地,控制电路132还可以包括一个或多个模块来将从流量传感器144接收到的原始数据转化为有意义的值(例如,转化为以NL/min表示的流速)和/或将从泵致动器204接收到的类似原始数据转化为有意义的值。可替代地,由该模块(或该多个模块)执行的功能可替换为由自适应控制器212执行。
计算机存储器208可作为任意类型的易失性或非易失性(例如,闪存)存储器实现,而自适应控制器212和/或上文描述的模块可作为能够提供这里描述的功能的任意的软件程序、硬件装置、或它们的组合来实现。例如,自适应控制器212和/或上文描述模块的每个可以是专用集成电路(ASIC)或现场可编程门阵列(FPGA)。可替代地,自适应控制器212可以使用能够用任何适合的编程语言或多种编程语言(例如,C++、,C#、Java、Visual Basic、LISP、BASIC、PERL等)来编程的通用微处理器(例如由Intel公司提供的任意的PENTIUM微处理器)来实现。本领域技术人员能够较容易地实现这些合适的控制编程而无需过多的实验。
在一个特定实施例中,如下面所描述的,编程控制电路132以周期性时间间隔从药物储存器108输送固定剂量的药物至目标部位,并配置控制电路132,把在每一个时间间隔上的泵200的状况存储在计算机存储器208中。在每个给药间隔上(或在其他周期性间隔上)可存储的一些示例性而非限制性的泵200的内部状况包括:通过电解电极134的电流、电解电极134的跨电压、或电解电极134的电阻;用于驱动电解电极134的总电荷;通过插管120的最大药物流速;通过插管120的药物流动方式的任何变化;泵200达到通过插管120的药物的特定流速所需要的激励时间;流动药物从特定流速缓降至零流速所需要的时间;泵200的初始激励和通过插管120的药物的初始流动之间的时间延迟;泵致动器204的效率(其在电解驱动泵200的情形中,可由泵送通过致动器204的电荷量和由此生成的气体量之间的比值定义);药物储存器108的内部压力;泵200经历的加速度;特别涉及流量传感器144结构体系的流量传感器参数(例如,在流量传感器144是电阻式温度探测器时,可能需要存储传感器和发热元件的电阻);以及泵致动器204、药物储存器108、和/或插管120的物理尺寸,它们可能由于阻塞、结疤或其他生化/生理事件而改变。
在一个实施例中,这些参数通过使用物理传感器直接或间接地测量,诸如,流量传感器144,药物储存器108或插管120内的压力传感器,加速计、陀螺仪、高度计,接近电解电极134的传感器(例如,用来测量电解电极134的电阻、通过其中的电流、和/或电解电极134处的电压或跨电压),或散布在泵200中的任意其他传感器。在其他实施例中,这些参数通过使用已知关系来确定。例如,通过插管120的药物流速可以通过在插管120中使用的压力传感器并利用压力和流速之间的已知线性关系来确定。在另一实施例中,这些参数中的大部分可通过分析用于驱动泵致动器204的电波形和/或通过分析由流量传感器144感测的流动曲线来确定。
在所有的情形中,如下文所描述的,控制电路132的自适应控制器212能够接收并处理参数数据并补偿泵200的任何状况变化,从而调节其操作以维持目标剂量水平。该“自补偿”可以通过存储上文所述的在输送先前剂量时的泵200状态的参数数据并通过考虑实时参数值来确定在进行下一剂量事件时用于电解电极134的最佳激励电流和/或其激励持续时间来实现。例如,如图3所示,自适应控制器212可以接收、分析并处理来自先前剂量的存储参数、来自泵致动器204的实时数据以及来自流量传感器144的实时数据(例如,流速数据),从而确定并引导恰当的输出信号至泵致动器204(即,为了以恰当方式驱动泵200)。针对初始给药,或在上述数据不可用的情形时(例如,由于泵200的复位动作),自适应控制器212可以利用一组预定参考的参数值。这些参考值可以具体为所使用的具体电解电极134的特性、所使用的电解溶液的类型、和/或电解致动器204、药物储存器108和插管120的物理尺寸。
在操作电解驱动泵200的一个模式中,使用恒定电流在可变量时间上驱动电解电极134。在该模式中,该恒定电流使通过插管120的药物流速单调上升直至关闭电流,此时,泵200中剩余压力引起流速的缓慢衰退直至流速为零。在针对该操作模式的功能性示例中,在每个给药间隔上将以下三个参数存储在计算机存储器208中:为驱动泵200而提供给电解电极134的电流(I);通过插管120的最大药物流速(Fmax);以及在泵致动器204停用(V关闭)后,由泵200基于剩余压力输送的液体(即,药物)的体积。该存储的信息然后用在将来剂量中以改善给药速度和精确性。例如,可以基于先前剂量数据调节用于驱动将来剂量的电流(例如,如果最大流速太小则增加,以及最大流速太高则降低),从而保持每个剂量的持续时间、并保持每个剂量所输送的药物体积相对地恒定。在一个实施例中,这通过如下所述的线性方式来实现:
I当前=F最佳/F最大,先前×I先前
其中I当前是在目前剂量期间要供给电解电极134的电流,F最佳是通过插管120的期望最大药物流速,F最大,先前是在先前剂量期间通过插管120的最大药物流速,以及I先前在先前剂量期间供给电解电极134的电流。
作为另一示例,泵致动器204的关闭时间可以替换为可调节的,或可额外调节的(例如,如果在泵致动器204停用后所输送的药物体积低于期望的则延迟关闭时间,以及如果在泵致动器204停用后所输送的药物体积高于期望的,则提早关闭时间)以保持所输送的药物体积保持相对恒定。这里也可以使用线性近似来实现,其中泵致动器204在满足如下条件后立即停用:
V累积+F/F最大,先前×V关闭,先前=V目标
其中V累积是目前为止当前剂量所输送的总药物体积,F是通过插管120的实时药物流速;F最大,先前是先前剂量通过插管120的最大药物流速,V关闭, 先前是先前剂量在泵致动器204关闭后所输送的药物体积,以及V目标是将要输送的药物的目标体积。在该方式中,自适应控制器212不断地调节激励泵200的方式并计算出泵200特性上的***性、非随机的变化。
当泵200是电解驱动泵时,对启动通过插管120的药物流动并随后达到特定流速所需的电流量以及当电解电极134不再施加电流后从药物储存器108输送的液体量的确定和控制是特别有利的。特别地,第一个参数是重要的,这是因为通过插管120的药物流动并之后达到特定流速所需的电流量取决于药物储存器108中剩余的液体多少。使用过低的电流在能量上并不经济,这是由于即使插管120中没有或有非常低的药物流过,所有***也都将要运转。另一方面,使用过高的电流将导致药物流速过冲至不安全水平。第二个参数同样是重要的,这是因为在泵200关闭后所输送的药物体积主要取决于电解腔112中的气/液比。针对泵200时间周期中后期使用的剂量(例如,其中泵200以电解腔112内高气/液比运转),在泵200完全停止前有太多的气体需要排出。但针对前期的剂量,情况却相反。
本领域普通技术人员应该理解的是,除了上面给出的两个示例,自适应控制器212可以在控制泵致动器204时,以及最终在从药物储存器108配给药物时,识别和分析泵200内部状况上的许多其他变化。例如,可能会期望泵200能使在一段指定时间内(t最优)的每个剂量达到最佳流速(F最优),然后让剩余的剂量维持该流速。实现这种情况的一种方式是通过使用恒定电流(I开始)驱动泵200的电解电极134以起动每个剂量,直到达到最佳流速(F最优),此时得到来自流量传感器144的反馈并使用算法(例如,比例-积分-微分(“PID”)算法或其他算法)调节供给电解电极134的电流,从而让剩余剂量维持最佳流速(F最优)。换言之,可以使用时变电流波形来驱动泵200。在一个实施例中,为了在一段指定时间内(t最优)达到最佳流速(F最优),逐个剂量地调节起动电流(I开始)。以类似于之前的方式,这可以通过使用线性近似(然而,本领域普通技术人员应该理解的是,也可以对此处获得的任何参数应用非线性近似)来实现。更具体而言,当前剂量的起动电流(I开始,当前)能够通过使用先前剂量的起动电流(I开始, 先前)和在先前剂量流速达到最佳流速(F最优)花费的时间(t先前)来计算,如下所示:
I开始,当前=t先前/t最优×I开始,先前
现参照图4,示例性图表300示意了上述对药物剂量水平自适应控制的效果。在该示例中,在每个释放事件期间待输送的目标剂量水平是200纳升(nL)。事件1对应基于参照参数值计算的180nL初始给药剂量。然后,自适应控制器212针对泵200参数(例如,如上所述的,可增加提供给电解电极134的电流量和/或其激励时间以增加输送给目标部位的药物体积)计算合理的调节值,直到在事件2上达到200nL的目标输送。如所示意的,在事件1和事件2之间可以存在因自适应控制器212过度补偿且泵200输送了多于目标剂量的剂量(例如,205nL)的时间点304。在这种情况下,自适应控制器212改进其针对泵200参数的调节值(例如,可降低提供给电解电极134的电流量和/或其激励时间以降低输送给目标部位的药物体积),直到实际达到了在事件2上的200nL的目标输送。
继续图4的图标300所描述的示例,由于泵200的一个或多个参数的变化,事件3中的剂量于是下降至190nL。能够变化并导致所输送药物剂量的这种降低(即,导致泵200效率的降低)的泵200自身内的示例性状况包括:电解电极134的降解(例如,冲蚀或腐蚀)、电解腔112的溶液中电解质浓度的减少、和/或一般的机械或化学损耗。作为响应,自适应控制器212随后如上所述的进行补偿以使得泵200在事件4上释放准确的药物量。因此,泵200动态地作用于泵200状况的变化。
图5A描绘了在没有控制电路132提供的反馈控制(例如,针对应用开环控制***的泵)下的泵200操作时的示例性流量曲线400和激励曲线404。如图所示,尽管激励电流保持相同(在图5A中针对前期和后期剂量的激励曲线404重叠),但由于泵送效率降低,后期输送的药物量减少。
图5B描绘了在由控制电路132提供的反馈控制下泵200操作时的示例性流量曲线408和激励曲线412。特别地,图5B示出了针对后期剂量如何增加泵送时间以补偿减少的泵200的效率。更具体地,针对后期剂量,泵200以相同电流激励更长的时间,从而成功输送了目标剂量。
图5C同样描绘了在由控制电路132提供的反馈控制下泵200操作的示例性流量曲线416和激励曲线420。特别地,图5C示出了如何通过提高后期剂量的激励电流以保持前期和后期剂量的给药时间恒定,同时仍能补偿减少的泵200的效率。前期和后期剂量的流量曲线416重叠,说明在这两个剂量期间输送了相同药物量。
C.基于目标部位状况的自适应控制
在其他实施例中,再次参照图1至图3,自适应控制器212同样能够接收来自监测药物输送治疗区域的目标部位传感器148的信息,并随后在某些时间周期改变目标剂量。更特别地,如果治疗区域的变化(例如,症状的恶化或改善、生物或生化参数的变化、电活动变化、压力变化等)需要更高或更低剂量水平或需要在剂量频率上变化,自适应控制器212能够控制泵致动器204以调节剂量并将其维持在新水平直到需要另一改变。换言之,自适应控制器212可以激励泵200以达到期望结果,诸如具体生理状态或生化参数的规律。如之前的,由目标传感器148感测的参数(例如,压力、温度等)可以存储在计算机存储器208中用于后期使用(例如,用于对比以确定待输送药物的合理剂量)。
作为示例,假设泵200每分钟输送200nL的初始目标剂量。在一段时间后,由于治疗区域的变化或给药体系的变化,剂量需要减少至150nL。则自适应控制器212可以操作泵致动器204以使得每30分钟输送150nL药物,直到由于治疗区域上发生另一变化或由泵200使用者发出了指令,或是其他情况。
有利地是,这种灵活性便于泵200能应用于更广泛的治疗方案,这些治疗方案可能要求在一段相当长的时期内会有不同剂量或不同剂量频率的交叠。
可选地,自适应控制器212可以编程以响应泵200自身状况的变化以及同时响应目标治疗区域状况的变化。换言之,自适应控制器212可以接受来自泵200内部传感器或其他装置以及来自目标治疗传感器148的数据,分析这两组数据,并控制泵致动器204以计算这两组数据。可替代地,在另一个实施例中,如果该确定性的参数是泵200自身的而不是治疗区域的,则自适应控制器212可以编程以例如基于因生理变化或结疤而在靶区内形成的阻塞来制止起动动作。
D.动态、自适应控制药物输送泵的示例性应用
图6示意性说明了根据本发明一个实施例的植入到患者眼睛中的药物输送泵100、200。如图所示,泵100、200置于眼结膜上,以及从中***插管120的远端进入眼睛后房。这样,插管120的远端(以及,因此,药物储存器108)与患者流体连通。之后药物输送泵100、200将治疗液体通过插管120和止回阀140给药至眼睛后房,其中止回阀140如前文所述用于阻止液体回流。特别地,通过使用自适应控制器212和其他控制电路132以上文所述的任意方式(例如,基于泵自身状况变化和/或基于目标部位状况)来控制泵致动器204,从而从药物储存器108输送一个或多个液体剂量穿过插管120并进入患者眼睛。
在其他实施例中,泵100、200用于给药液体至眼睛前房,其与后房由晶状体隔开。然而,更一般的是,可应用如前所提及的泵100、200来给药液体至患者身体的任何部位。
作为另外示例,泵100、200可以是粘附于身体的电解驱动泵,用于药物注入至患者皮下组织。例如,泵100、200可以在三到七天内连续地输送胰岛素至患者身体。尽管患者可能需要重新计算他或她的胰岛素输送(例如,随时间增加或减少基本速率),以及编程泵100、200以在饭后提供间歇性大剂量峰值的胰岛素。因此,该示例中的泵100、200能够调节电解以增加或减少胰岛素流量,从而随时间来精确地输送准确的液体体积。此外,在一段较长时间上的药物输送,如三天,会使泵100、200经受新的环境状况。例如,患者可能驾车从低海拔到高海拔高度或者在密闭飞机里飞行。泵100、200能够使用两个环境信号(例如,高度计、压力变化、流速变换等)来调节药物流量并确保准确的药物输送。
作为又一个示例,泵100、200可以使用来自加速计或陀螺仪的输入来感测患者位置。例如,泵100、200能够感测患者在之前7天晚10点至早6点的时间(由于,例如,患者在睡觉)是平卧的。在这种情况下,泵100、200则可以识别患者的睡眠时间(即,从感测到患者处于平卧位置)或REM睡眠周期,随后使用该信息来注入不同的药物体积(或在指定时间的药物),从而来适应最佳状况。例如,可以在睡眠时间调节泵100、200的流速至由医生预定的量(例如,通常最好的是在REM睡眠周期期间注入一些青光眼药物至患者眼内从而使药物更好地遍布在整个眼中,而一些用于视网膜的诸如抗-VEGF药物会作用一个月的时间,因此应该平静地注入玻璃体内;此外,应当在睡眠期间以较低基础速率注入胰岛素或注入更少的止痛药物)用于注入。与理解患者何时在睡眠形成对比,泵100、200还可以识别患者何时在运动或患者何时不是仰卧的,并相应地调节药物注入(例如,调节到医生预编程的针对在某些动作期间的注入)。
有利的是,能够将这里描述的控制电路132用于特性不相同的泵,这或是由于使用者选择的偏爱或是由于在制造过程中产生的变化。例如,使用的电极或电解液的类型决定了电解驱动泵的性能。然而控制电路132具有足够的鲁棒性和通用性以适应以各种参数值操作的泵。作为另一示例,流量传感器元件的电阻的制造加工偏差可以通过控制电路132的自适应性质得到调节。更具体而言,由加工偏差引起的流量传感器元件的电阻不匹配会导致产生偏移,对此控制电路132能够补偿。
可选地,控制电路132还可以通过监测某些关键的泵参数来增强泵100、200的安全性以及效能。例如,可以针对每个参数或针对对应于具体泵状态的一些总参数组合来限定允许范围,在此允许范围泵100、200持续正常运转。如果单个参数或一些总参数组合没有落入这些预定范围,则将在泵100、200内触发动作,诸如关闭或给使用者发出需要做出响应的报警。例如,泵100、200可以通过光照、声音、震动或打击来报警患者。在一个实施例中,编程以在患者移动时产生报警从而最大可能性的使患者接收到报警,以及还有在患者睡眠时避免报警来保存电池能量。
在一个特定示例中,控制电路132能够响应并预知流量传感器144的故障。其中,例如,流量传感器144包括一组发热器和电阻温度探测器,由于使用中经历的热应力,这些元件中的一个可能会在不确定数量的剂量后开始发生故障。控制电路132能够周期性的(例如,逐个剂量地)监测到发热元件的电阻,并探测电阻的变化,其能够指示开始故障或完全故障(诸如开路)。包括传感器和致动器的利用电阻或电容元件的其他泵组件也可以类似的由控制电路132监测以保证正常的功能运转。
描述了本发明的某些实施例后,对本领域普通技术人员显而易见的是可以使用包括此处公开概念的其他实施例而不背离本发明的精神和范围。例如,尽管已经主要描述了自适应控制器212和其他控制电路132结合电解驱动泵使用,而这仅是示意性的。本领域普通技术人员应该容易的意识和理解到自适应控制器212和其他控制电路132还可以应用到其他类型的药物输送泵中,诸如基于如电渗透、机械激励、或压力驱动机制的那些药物输送泵。因此,所述实施例在各方面应理解为仅是示例性的而不是限制性的。
Claims (23)
1.一种药物输送泵,包括:
药物储存器;
插管,其用于将液体从储存器引导至目标部位;
泵致动器,其用于推动来自储存器的液体穿过插管;以及
电路,其用于控制致动器以i)初始地输送随时间基本固定的液体剂量至目标部位,和ii)补偿泵的状况变化以维持或恢复随时间基本固定的液体剂量至目标部位的输送。
2.权利要求1所述的泵,其中所述电路包括存储器,其用于存储先前输送事件时泵的状况。
3.权利要求1所述的泵,还包括流量传感器,其用于测量通过插管的液体的流速。
4.权利要求3所述的泵,其中所述电路至少部分地基于所述流速的分析控制致动器。
5.权利要求4所述的泵,其中所述电路还基于所存储的先前剂量时泵的状况控制致动器。
6.权利要求4所述的泵,其中所述电路还基于来自致动器的实时数据控制致动器。
7.权利要求1所述的泵,其中所述致动器包括:
电解腔;
可膨胀隔膜,其隔开所述腔和所述储存器并提供它们之间的流体屏障;以及
电解电极,导致在电解腔内放出气体,由此扩张隔膜从而推动液体从所述储存器进入所述插管。
8.权利要求7所述的泵,其中所述可膨胀隔膜通过改变供给电极的激励电流来调节。
9.权利要求7所述的泵,其中所述可膨胀隔膜通过改变电极的激励持续时间来调节。
10.权利要求7所述的泵,其中所述电解电极通过恒定电流来驱动。
11.权利要求7所述的泵,其中所述电解电极通过时变电流波形来驱动。
12.权利要求1所述的泵,其中所述基本固定的液体剂量在周期性时间间隔上输送至目标部位。
13.权利要求1所述的泵,其中所述基本固定的液体剂量随时间连续注射输送至目标部位。
14.一种从药物输送泵输送药物至患者的方法,该药物输送泵包括药物储存器和泵致动器,该致动器用于推动液体从储存器进入患者体内,该方法包括:
建立药物储存器和患者之间的流体连通;以及
控制该致动器以i)初始地从药物储存器输送随时间基本固定的液体剂量至患者,和ii)补偿泵的状况变化以维持或恢复随时间基本固定的液体剂量至患者的输送。
15.权利要求14所述的方法,还包括存储先前剂量事件时泵的状况。
16.权利要求14所述的方法,还包括测量进入患者的液体流速。
17.权利要求16所述的方法,其中控制泵致动器包括分析以下中的至少一个:流速、已存储的先前剂量的泵状况或来自致动器的实时数据。
18.权利要求14所述的方法,其中所述泵是电解驱动泵,以及其中控制所述泵包括改变供给电解电极的激励电流。
19.权利要求14所述的方法,其中所述泵是电解驱动泵,以及其中控制所述泵包括改变电解电极的激励持续时间。
20.权利要求14所述的方法,其中所述泵是电解驱动泵,以及其中控制所述泵包括采用恒定电流驱动电解电极。
21.权利要求14所述的方法,其中所述泵是电解驱动泵,以及其中控制所述泵包括采用时变电流波形驱动电解电极。
22.权利要求14所述的方法,其中所述基本固定的液体剂量在周期性时间间隔上输送至目标部位。
23.权利要求14所述的方法,其中所述基本固定的液体剂量随时间连续注射输送至目标部位。
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EP2467797B1 (en) | 2017-07-19 |
US9199035B2 (en) | 2015-12-01 |
WO2011022484A1 (en) | 2011-02-24 |
JP5758388B2 (ja) | 2015-08-05 |
KR20120068867A (ko) | 2012-06-27 |
JP2013502279A (ja) | 2013-01-24 |
US9283322B2 (en) | 2016-03-15 |
AU2010284216B2 (en) | 2015-10-15 |
US20140074058A1 (en) | 2014-03-13 |
KR101697388B1 (ko) | 2017-01-17 |
CA2771584A1 (en) | 2011-02-24 |
CN102576385B (zh) | 2016-02-24 |
US20110202032A1 (en) | 2011-08-18 |
EP2467797A1 (en) | 2012-06-27 |
MX2012002063A (es) | 2012-08-01 |
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