CN104245014B - 时间依赖性的药物输送装置 - Google Patents
时间依赖性的药物输送装置 Download PDFInfo
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Abstract
一种方法及装置,用于物质的自主可调变速率输送。若干实施例中,输送装置为可编程的。若干实施例中,输送装置为可抛式。可选择地,输送的速率可根据所述装置之一组件的温度自动进行调节。可选择地,在装置的激活与输送物质之间可能有时间延迟。
Description
技术领域
本发明及其若干实施例涉及一种装置及方法,用于输送物质,具体言之,但非特定地,涉及一种可抛式的装置及方法,用于以可调变速率输送药物至非技术性及无监管的接受者。
背景技术
Sage的美国公告专利No.5,957,895涉及一种藉由注射或通过患者的皮肤输送液态治疗制剂至患者体内的器具,更具体的涉及一种低阶自动注射器,可不明显地穿戴于患者的服饰下并容许给药液态治疗制剂(例如:胰岛素)一段持续的时间,及包含一自排放式的储槽,以免除泵或其他型式释出器的需求。
Radmer的美国公告专利No.7,780,636涉及一种器具,适于应用在使用者的皮肤表面,及包含一经皮肤器,例如是以无菌状态供应的针或针状的构件及可随之使用的经皮肤器。具体方面,所述发明涉及一种经皮肤器,用于插入至受测者体内的选定位置,将药物以皮下注射、静脉注射、肌肉注射或皮内的方式输送至受测者,所述针也连接至用来容纳药物的储槽。
Gross的美国公告专利No.5,997,501揭示一种皮内的药物輸送器包括具有储药槽的壳体。一微处理器控制的电解槽提供气体以扩张一气体产生腔体及藉此收缩所述储槽。一中空针在其内面端与所述储槽连通,从壳体的较低表面延伸,如此一来所述储槽的收缩迫使药物从中溢出,以通过针注入使用者。所述器具允许相对大分子量的药物以慢速、可控制的速率输送。
Genosar的美国公告专利No.7,918,843揭示一可控制的药物輸送器,用于输送液态可注射的药物,所述器具包括一储药槽、一药物輸送器、一位移产生电池及一电流消耗回路,由电池产生的位移,当电流从电池藉由电流消耗回路消耗替代储药槽的屏障,藉此使所述储槽经由所述药物輸送器将容纳于其中的可注射药物液态排出,及所述药物輸送器还包括一控制器,用于响应一表征由电池消耗产生的偏压的测量参数,施加一可变负载于电池,以控制电池消耗产生一基本固定的电流,藉此使得所述药物輸送器输送一基本固定的药物輸送速率。
Pesach等人的美国公开专利No.2011/0184342及国际专利申请号WO2009/081262专利揭示一装置及一系统,用于控制及/或管理给药至患者身体的药物。所述装置包括一药物输液器设置用以在患者体内的预定位置输送药物,至少一传感器设置于所述药物输液器并用于量测与患者相关的特性,所述特性选自由物理性质、生化性质、环境性质及药物相关性质组成的组合,一控制器设置于所述药物输液器并用于接收至少一来自传感器所量测的表征相关特性的数据,并根据接收的数据决定药物輸送速率。所述药物輸送器用于依照预定的药物輸送速率将药物输送至患者体内。
本案作者的美国公开专利No.2011/0178472及国际公开专利WO2011/090955揭示一适用于液体的针组件并连接一含有欲输送至受测者的物质的药筒。所述针组件特征在于包括一偏压器及一偏压器释出装置,所述偏压器用于施加一偏压于针,使针从壳体凸出并穿刺入受测者。所述偏压器释出装置包括一偏压器制动器,在初始状态下能局限偏压器的移动。
一安全闩位置传感器用于感测当安全闩移动至一代表所述器具已经配置于一患者上的上方位置。一控制器用于在预定时间的延迟(即,5-15秒钟)后激活一致动器的操作,以确保所述药物输送裝置确实位于患者身上用于输送药物的地方。当激活后,所述致动器将所述偏压器制动器移出开孔。所述致动器转动一驱动齿轮,从而带动一正齿轮旋转一转轴。转轴的转动导致偏压器制动器沿着螺纹部分线性移出所述开孔。当所述偏压器制动器抵达所述螺纹部分的尾端,其在转轴上自由地转动且不再往前移动。一旦偏压器制动器移出所述开孔,所述偏压器不再被锁固并推动一针,藉此穿刺患者的皮肤。
其余的背景技术包括相同作者的美国公开专利No.2011/0178472,Tsukada等人的美国公告专利No.6,530,901及Knauer的欧洲专利No.EP0744975。
发明内容
简言之,本申请案之一实施例包含一装置,用于输送药物至接受者。所述装置包括一经皮肤器,设置用于插入至接受者内一处。一释出机构,设置用于通过经皮肤器输送药物至所述处。一处理器,设置用于控制所述释出机构。一去激活机构,设置用于在输送药物后,使所述装置去激活。一温度传感器,设置用于感测所述装置之一组件或所述药物的温度。所述处理器程式设计成在激活后及开始输送药物前,等待一段预定时间,还能根据所述温度传感器所量测的温度调整所述等待时间。
本发明其他实施例包含一装置,用于输送药物至接受者。所述装置包括一经皮肤器,设置用于插入至接受者内一处。一释出机构,设置用于通过经皮肤器输送药物至所述处。一温度传感器,设置用于感测所述装置之一组件或所述药物的温度。一处理器,设置用于控制所述释出机构,及依据温度传感器所感测到的温度调整输送药物的速率。
本发明另一实施例包含一种通过便携式药物輸送器输送药物至接受者的方法。所述方法包括插入一经皮肤器至接受者内一处,藉由便携式药物輸送裝置经所述经皮肤器输送药物至所述处,及依据所述便携式药物輸送裝置之组件或所述药物之温度,决定输送速率。
附图说明
此处,仅藉由范例并参考附加的附图,描述本申请案的若干实施例。图示中的细节,强调本申请案的实施例的特征。以此,附图中的描述对本领域普通技术者而言,能了解如何实行所述实施例。
图1a是本发明的第一较佳实施方式的时间轴示意图。
图1b是本发明的第二较佳实施方式的时间轴示意图。
图1c是本发明的第三较佳实施方式的时间轴示意图。
图2是本发明的较佳实施方式的简易功能性模块示意图。
图3a是依据本发明的时间相对于温度及输送速率及较佳延迟注射用量的图表。
图3b是依据本发明的时间相对于温度及输送速率及较佳调变速率著数用量的图表。
图4是示意本发明的较佳实施方式的流程图。
图5是本发明的其他较佳实施方式的模块示意图。
如下具体实施方式将结合上述附图进一步说明本发明。
具体实施方式
除非另有说明,所有用于此处的技术及/或科学用语具有与本申请案所属技术领域中普通技术技术人员理解的相同含意。虽然类似或相当的方法及材料可用于实施或试验本申请案的实施例,以下仍提供例示性的方法及/或材料。为了避免矛盾,将控制本说明书,包含定义。此外,材料、方法及例示并非意图限定。
所述实施例的方法及/或系统的实施可能涉及手动地、自动地或其组合执行或完成所选任务。再者,根据本申请案方法及/或系统的实际仪器及设备,数个所选任务可使用操作系统藉由硬件、软件或固件或其等之组合而执行。
例如,根据本申请案的实施例,用于执行所选任务的硬件可例如以芯片或回路实施。作为软件,根据本申请案的实施例,所选任务可使用任一适当的操作系统,藉由计算机执行多个软件软件指令而实施。在一本申请案的例示实施例中,根据此处描述的方法及/或系统的例示实施例,一个或多个任务藉由数据处理器,例如一用于执行多个指令的计算平台而实施。可选择地,所述数据处理器包括一用来储存指令及/或数据及/或非依电性储存的依電性内存,举例而言,一用来储存指令及/或数据的磁性硬盘及/或抽取式的媒体。可选择地,也可提供网络接线。也可选择性提供一显示器及/或用戶輸入器,例如键盘或鼠标。
于本申请案及其若干实施例,涉及一用于输送物质的装置及方法,更具体,但不限于涉及一以可调变速率输送药物至非技术性及无监管的接受者的可抛式装置及方法。
于若干实施例中,所述装置可依时间调变速率排程而自主地输送药物。可选择地,药物輸送前可能有时间延迟。可选择地,时间延迟及/或输送速率可根据装置之组件的温度(例如:药物的温度及/或电源的温度)而调整。若干实施例中,药物的接受者能够依据个人喜好(例如,降低注射引起的疼痛)而调整输送速率及/或时间延迟。可选择地,输送的速率可低于最大输送速率。所述最大输送速率可依据一个或多个生理极限、所述注射装置的机械极限及/或调控极限而决定。举例而言,若干实施例中,输送速率可能介于最大输送速率的20%及80%之间。
若干实施例中,输送的最大速率可选择地介于10毫升/小时及100毫升/小时。总输送量可选择地介于0.5毫升及20毫升。输送的总时间可介于5秒钟及20分钟。若干实施例中,输送的总时间可从开始输送至输送结束量测。可选择地,开始输送可从激活装置的时间、及/或从配置装置的时间、及/或实际开始输送物质的时间而开始量测。可选择地,输送结束可从使装置去激活、及/或在不再输送物质的最早时间点、及/或将装置从接受者移除的时间点而量测。
依赖温度的输送
若干实施例中,所述装置可编程为在激活后及开始输送前,等待一段2-20分钟的固定时间延迟。延迟时间的长度可为估计所述装置的温度感测组件达到工作温度的时间。举例而言,所述温度感测组件可包括所述药物及/或一电池。
若干实施例中,所述装置可保存于介于1℃及8℃的冷藏。此等低温可能导致粘性增加、电池能效降低,及/或增加接受者的疼痛等问题。在注射前,初始的时间延迟允许来自接受者身体及/或来自空气的热度,使温度感测组件回温至较佳工作温度。若干实施例中,所述较佳工作温度可介于10-37℃。
若干实施例中,可供应一传感器以量测温度感测组件的温度。举例而言,供应一用于量测所述药物或所述电池的温度热电耦。或者,所述量测的参数可包括相关参数的替代指标。举例而言,若干实施例中,所述相关参数可能为所述药物的温度,但可选择性地量测所述电池的温度。所述药物的温度可能从所述电池的温度推断。若干实施例中,还可量测所述电池的电压电位及/或所述药物的粘性。所述电池的温度及/或所述药物的温度可从所述电池电压及药物粘性推断。
若干实施例中,输送速率可根据所述温度感测组件的温度而调整。举例而言,当所述装置冷的时候,输送速率可能降低。若所述装置回温则输送速率可能增加。
若干实施例中,输送排程可能依赖多个因子。举例而言,可能会有预先编程设计的时间延迟,及/或传感器用于侦测所述装置是否正确地与受测者接触,及/或一或多个温度传感器用于测试即将被输送的物质的温度,及/或电池的温度。举例而言,输送可能仅在所述电池已达到某温度的时间延迟后开始,及所述输送速率可能依赖所述物质的温度。
随接受者修正的输送
于本申请案的若干实施例中,所述输送速率及/或时间延迟可能随著接受者在输送物质的期间而调整。举例而言,一注射药物泵的接受者可能想要降低注射的速率。举例而言,降低注射速率可能会减少注射的疼痛。在某些情况下,药物的接受者可能想要藉由增加输送速率而快速结束治疗。
若干实施例中,接受者能调整的时间延迟及/或输送速率可能受到限制。举例而言,接受者也许能够降低所述输送速率至较佳速率的50%或增加输送速率达到较佳速率的200%。可选择地,提供一使用者输入界面,藉此照护者及/或用药接受者可调整输送速率。
在医疗程序后跟随时间延迟而输送
本申请案的若干实施例中,所述装置可编程为在医疗程序后经过一推荐的时间延迟后进行输送药物。举例而言,有时随著医疗程序,在程序后需要在一指定时间注射药物。可选择地,当接受者接受一监督的医疗程序时,可激活一药物输送装置及/或装配该药物输送装置至接受者。所述装置可能编程为等待一段指定时间,然后,在指定时间输送药物至接受者。若干实施例中,所述时间延迟可介于1小时及48小时。可选择地,注射时间可能以经过时间或绝对时间定义(譬如,一天中的某一时刻及/或排程小时)。
便携性
若干实施例中,所述装置将对于接受者的不便最小化。举例而言,所述装置可能体积小且轻。所述装置可能选择性的穿戴于接受者。穿戴所述装置可能包括,例如,将所述装置装配于接受者,及/或以装配于接受者的服饰的方式携带所述装置,及/或将所述装置捆扎于接受者。举例而言,所述装置可能粘贴至接受者的皮肤(例如,通过贴附剂)。可选择地,所述装置也许不需要被接受者持续地携带。
可选择地,所述装置可能少于5cm长,及/或少于5cm宽,及/或具有少于3cm的厚度。可选择地,所述装置的总容积可能少于100-200毫升。可选择地,所述装置与物质的全体重量可能少于100-200g。可选择地,所述装置中物质储槽的容量可能介于5-30毫升。可选择地,所述装置可防震及/或防水。说明书全文及权利要求通篇的用语“储槽”包括任何药物的容器,例如但不限于药筒、药水瓶、注射筒、瓶子、安瓿及更多,及不限任何尺寸及形状。
在详细说明本申请案至少一较佳实施例前,需理解本申请案不限定于应用的详细解释及组件的配置,及/或下述的方法,及/或图示的示意,及/或实施例。本申请案能够以又一实施方式或以各种方法实施及执行。
例示的时间轴
在医疗程序后输送药物
图1a至图1c为表示一次性使用的時間依賴性的药物輸送裝置如何使用的实施例的时间轴。图1a至图1c的实施例中,患者(接受者)在门诊的医疗程序后,需要注射药物。
若干实施例中,所述装置为医药泵。本申请案不限于药物泵,且可用于任何种类适当的释出装置,并非仅藉由针穿刺患者,而是能够藉由喷洒(所述物质藉由装置按计量至喷洒喷嘴),微针阵列或其他。
无监管的输送医药
若干案例中,患者宁愿回家而非留置机构等待护理人员执行注射。供应所述接受者一即使在远程位置(例如,患者的家或在室外散步),能够无需监管(例如,藉由医疗人员及/或警示的接受者),而选择性自主地输送医药至接受者的便携式装置。可选择地,即使接受者处于睡眠中,所述输送可经排程而发生。图1a至图1c的实施例中,将注射4毫升的液体。
接受者可能具有受限的能力
某些情况,接受者可能没有能力对于自己的治疗担负责任。举例而言,接受者可能包括小孩及/或可能引起接受者疲惫或混乱的医疗程序(例如化疗)。
由供应者编程;由开药方机构装填及装配
请参照图1a所示,在本实施例中,要被注射的药物是可选择地被药品分装厂包装在密封的药水瓶里,且注射器是选择性地可由监管人员编程后提供,药品分装厂可选择性地在注射器设计一程序让药物在一药疗程序后经过一等待时间片段才释放药品。依据药物处方,药品分装厂可选择地将注射器个别包装。
在本实施利中,以注射一解毒剂入化疗药物中为例说明,在治疗后12小时解毒剂才注入,可选择地,药品分配商亦可预先准备一编程好的注射器,让其在激活后12小时输送解毒剂,在此实施例中,注射器与药物可选择性地被分别包装,举例来说,药物及注射器可以附上说明书给医疗人员的方式一起销售给医疗机关。
请参照图1a所示,药品及注射器可选择性地由医疗机关保存直到需要时,药品及注射器可分开或一起保存,保存时间可持续几天或一年以上或几年。
请参照图1a所示,当选择注射器时,医疗机关可选择性地装填药物入注射器内,激活注射器且配装注射器于一接受者104a(如下面在不同的实施例中说明,注射器的激活可在装填药物之前或之后),可选择性地,一旦配装好注射器,注射器可在不需要连接外部资源(例如一外部电源供应器、一外部储药槽及/或一外部控制单元)下运作。
在本实施例中,解毒剂装填进注射器里且注射器在化学治疗后立刻被激活,一旦被激活,则注射器可在治疗后一方便的时间点装配于病人上,举例来说,注射器可在化疗程序后马上或更晚装配于接受者上,只要在离开医疗机关之前即可。
在另一实施例中,注射器可选择性地在治疗程序结束以及最佳注射时间之间设计一长于等待时间片段几小时的时间延迟程序,于此,医疗人员可在开始程序开始之前激活注射器及/或装配注射器于接受者上。
如图1a所示,在注射器已经装配之后,接受者可选择性地离开医疗机关的监管(例如回家),注射器可自主地在指定的等待时间片段结束后输送药物(如图1a-c的实施例中所示,药品在药疗程序后12小时被摄入),因此,即使在接受者睡觉时及/或忘记时及/或无法自己注射的状态下,仍可在正确的时间摄入正确的药物。选择性地,注射器可对接受者在注射开始前提出警告(例如经由响铃的警报或震动)。
如图1a所示,在激活注射器12小时候激活注射,在注射开始时,药物的温度已经均衡于室温以及接受者的皮肤温度之间,且立即以每小时60毫升的较佳的速度激活注射,直到规定的全部药量(4毫升)被注射完毕(在图1a的实施例中,4毫升的药量是以每小时60毫升的速度注射4分钟)
通常较佳地,是以接近最高注射安全的速度来注射,此最高安全注射速度可能会受限于注射设备的机械限制及/或病人生理限制及/或法规标准。注射使用愈高速度所花的时间愈少,亦减少发生注射程序可能的干扰。
当注射结束后,注射器本身可选择性地去激活108a,去激活108a可避免发生错误的使用或不测的事件发生。可选择性地,去激活108a可包括永久地关掉输送装置,在其他实施例中,去激活亦可藉由使注射器符合城市垃圾的规定而能够直接抛弃注射器至城市垃圾桶。
举例来说,注射器可藉由保护注射器针来去激活108a,保护针避免发生被意外针刺,例如藉由去激活装置收垃圾人员则可避免被针刺,举例来说针保护装置可包括把针缩回及/或运用一针盖可自动去覆盖凸出的针,可选择性地,去激活步骤可在输送药物达到一规定量后及/或依赖一动作(例如当装置从接受者移开)后被触发。
在其他实施例中,一药物输送装置可用于当机器发生故障时自动去激活及/或警告接受者,举例来说,当所述装置被命令输送药物但并未正确地装配于接受者时,或电池的电力过低时,则可自动地永久去激活。
在一处方机关编程;由接受者装填及装配
请参照图1b所示,依据第二实施例之一种可选择时间轴来使用的注射器,所述注射器供应给医疗机关时是处于非编程的状态,在本实施例中,医疗机关的监管人员可依据接受者的需要编程注射器之后给予注射器以及药物至接受者104b。
在其他实施例中,所述装置可被编程为一旦激活后立刻输送药物(接受者被授权在对的时间装配以及激活所述装置),可选择性地,此装置可编程为具有一时间空窗期,当接受者太早激活所述装置,所述装置可等待直到所规定的输送药物之前的时间,另外,当接受者忘记去激活所述装置,警告器则响铃,提醒接受者去装配且激活所述装置。如果接受者太晚激活所述装置,则会反应发生错误的情况,另外,当错误的情况(例如所述装置太晚被激活)发生时,所述装置可设计警示接受者及/或医疗监管者,在此情况,医疗监管者则可与接受者联络(例如打电话)去提醒病人装配装置及/或确认药物有正确地被输送。
在其他实施例中,接受者可保管注射器及药物直到医生规定的时间。直到在规定的时间前,接受者从保存处取出注射器、装填药物,装配注射器于身上且激活所述注射器。
如图1b所示,一旦激活,皮下注射针被插进接受者,且药物被注射进去106b,可选择性地,注射的速度为注射物质温度的函数,在此实施例中,接受者保存药物在冰箱且在填充以及激活注射器之前没有让药物回温到室温。
所述低温可能会产生不想要的后果,例如,当温度下降时药物的粘度增加,因此需较大的力气以及对泵机构施加相对较大压力,才能在高速下经由细小的皮下注射针推进此低温且高粘度的药物,而高压可能造成装置机器性地损坏,低温电池相对高温电池可能产生较少的电流及/或持续较少的时间,低温电池可能无法产生足够的电力以高速去推进一低温且粘度高的药物,一旦无法在一规定的速度下推进药物可能造成装置当机。且病人需承受更多的痛楚当注入的是一低温药物而不是一室温或体温的药物。
许多低温的副作用可能在降低注射速度达到缓和,例如,注射速度可降低到一远低于依据一室温药品及/或注射器所决定的最大值及/或最佳注射速度值。
可选择地,当药物是低温状态时,在药物开始注射时,机器是冷的(参附图3b),注射速度可选择低于最佳速度(每小时60毫升)注射。注射期间以较慢的速度注射可能造成注射的时间增加。以图2b所示,当既定量(4毫升)注入需时7分钟后注射才结束,在注射完毕后,注射器将自主地去激活108b。
由供应者编程;装填及由接受者装配及激活
如图1c所示,依据第三实施例之可选择时间轴来使用的注射器,所述装置可由一药品分配商选择性地供应102c、编程以及装填,药物以及注射器一起保存且贩卖给一医疗机关及/或一药商,装填好的注射器给予104c及/或卖给接受者。
接受者保存注射器及药物直到规定的注射时间,一旦到达规定的注射时间,接受者从保存处取出注射器109,激活注射器且装配到其皮肤上。
在激活以及装配之后,注射器可等待一编程的时间延迟且不须接受者进一步的动作而自动地激活注射,如图1c所示,编程的时间延迟为7分钟,此时间预估是考虑给药物从保存温度回温到一较佳的注射温度所必需的时间(参见图3a所示)。在经过等待时间片段后,药物以每小时60毫升的最佳速度注入4分钟直到规定的剂量4毫升被输入,在注射后,注射器自我去激活108c。
图2为表示药物輸送裝置的例示实施例的简易功能性模块。所述例示的装置设置用于简化药物的家用输送。药物保存于储槽288。控制器251根据温度传感器274的输出及/或编程于内存294的指令,藉由释出机构257而管理药物的输送速率。可选择地,使用仅能由合格人存取的编码界面243(例如使用一界面模块)执行编程。举例而言,监管的医疗人员能编码所述装置。可选择地,所述装置的接受者不能更动程式。
某些情况,所述装置或其组件(本文中,电源262或电池及输送的物质视为所述输送装置的组件)将保存于冷藏。选择性地将控制器251编程为延迟一段足以使所述组件回温的时间再输送。例如,指令可储存于内存294,藉以在所述装置激活后及开始输送物质前等待3-20分钟。或者,指令可储存于内存294,藉以随时间升高输送速率。
若干实施例中,可根据温度传感器274的量测而调整输送速率。若干实施例中,一或多个温度传感器274可量测储槽288的温度、电池的温度262及/或所述输送装置之其他组件的温度。
在其他实施例中,输送可藉由控制器251自动及/或手动处理,及/或與物質的輸送同步。举例而言,可选择性地提供一插入机构290用于将针插入接受者的皮肤。经由针的插入可开启输送所述药物的路径。可延迟至少所述等待时间的一半才执行插入。
还可选择性地提供一去激活机构261。去激活机构261可在输送指定量的物质后及/或在所述装置从患者皮肤移除后,使所述装置去激活。
时间依赖性(time dependent)的温度变化和输送排程(delivery schedule)的示意图
图3a及图3b为二示意图,说明输送装置(delivery apparatus)及其组件(component)时间依赖性的温度变化和输送排程。多数的物質(Many substances)是保存在低温(例如置于一冰箱),在某些情况下,预装填至(preloaded)输送装置的药物和输送装置可选择性地同时保存在一冰箱中。
如图3a及图3b所示之实施例,被输送的物质为10毫升的液体,将以最高速每小时100毫升的速率输送;于所述实施例中,所述输送装置被保存在2℃的冰箱中。在“t=0”的时间点,所述输送装置及预装填至所述输送装置的所述物质被移出所述冰箱,电池和所述物质的起始温度(starting temperature)是2℃。
自所述冰箱移出后,所述输送装置很快地被激活;如图3a及图3b所示之实施例,被激活的所述输送装置即刺入接受者的皮肤,来自接受者身體和环境的热缓慢地传输至所述输送装置,使所述输送装置(包含所述电池及所述物质)升溫;最終所述输送装置的各組件會升至一低于所述接受者皮肤而高于室温的温度,且达成平衡;当达成平衡时,所述温度大致维持在一常数。
时间延迟(time delay)后的固定速率输送
图3a为输送装置可选择性实施一固定时间延迟的实施例。在所述时间延迟的期间,输送速率为零;在所述时间延迟后,以一有限的固定速率输送。如图3a所示,横座标是以分钟为单位的时间,左侧纵座标是以摄氏为单位的温度,右侧纵座标分别是以毫升/每分钟为单位的流速及以毫升为单位的累计流量。结合左侧纵座标,为一输送装置内部的一时间依赖性的电池温度302及一时间依赖性的药物(即所述被输送物质)温度304;结合右侧纵座标,为所述累计输送的体积308及输送实时流速306。
固定排程
如图3a所示之实施例,所述药物和所述电池的起始温度约为2℃,所述输送装置被编程(programmed)在被激活后,可选择性地等待5分钟,之后可选择性地以最高速率输送直到预定体积的药物被输送完成。在一工作温度为10℃下,接受者身体和环境对所述药物加温所需的时间估计是在5分钟内。在所述工作温度下,所述泵可安全地以一所需注射速率输送所述药物。
最高输送速率
在若干实施例中,最高输送速率视被输送的药物而定;例如,粘度较高的物质,可以较慢的速率注射,且/或会引起较剧烈疼痛的物质,可用较慢的速率输送。选择性地,最高输送速率可由供应商编程在所述输送装置中。选择性地,最高输送速率可视病患而定,举例来说,当施用于一孩童时,最高输送速率会低于施用于一成人,或者患者表达希望以较长时间较不疼痛的方式进行注射。选择性地,较佳的输送速率可由医疗人员设定所述输送装置的编程。
温度依赖性的输送速率
图3b为一实施例,说明输送速率随被输送物质的温度变动的示意图。横座标为以分钟为单位的时间,左侧纵座标为以摄氏为单位的温度,右侧纵座标分别是以毫升/每分钟为单位的流速及以毫升为单位的累计流量。结合左侧纵座标,为一时间依赖性的电池温度302’及一时间依赖性的药物(即所述被输送物质)温度304’;结合右侧纵座标,为所述累计输送的体积308’及输送瞬时流速306’。
插入针(Insertion)
如图3b所示之实施例,所述输送装置具有一温度传感器,可用于感测所述被输送物质的温度。在此一实施例中,所述输送装置在被激活及装配于接受者后,可选择性地编程,将一针插入接受者。
温度依赖性的输送速率
在插入针后,可选择性的立即激活输送,其输送的速率动态地随温度传感器感测的温度而调整;在此实施例中,输送速率是与药物的温度成线性比例关系直到达到最高传输速率。直到预定体积的药物被注射完成,所述输送即停止。温度依赖性的输送速率可允许较固定时间延迟更短的操作时间,且确保所述机构(mechanism)及接受者免于在高输送速率下输送低温物质。
在若干实施例中,所述输送速率可以是一复杂的时间函数。举例来说,可包含一段输送速率为零的时间延迟。此外,可以包含一段上升期,其中所述输送速率为随时间增加的函数(选择性地,在一段时间内,输送速率与时间可呈线性比例或非线性比例);选择性地,可以包含一段以最高速率输送的期间。
在若干实施例中,所述输送速率可以是依赖于所述药物温度的估计值。选择性地,在不需温度传感器的情况下,所述输送速率可随估计的温度而上升。选择性地,在一个不太坏的情况下,可选择输送速率;举例来说,为了使一药物回温,该药物初始温度介于-5℃到10℃之间,且/或在低温环境下介于-10℃到10℃之间,且/或接受者的低体温介于29℃到37℃之间,输送速率可以根据一较佳的估计速率缓慢地上升。此外或选择性地,输送速率可视标准情况即时变换,举例来说,在一药物起始温度介于2℃到25℃之间、环境温度介于2℃到25℃之间、接受者的低体温介于36℃到38℃之间的情况下,输送速率可以依随时间增加。
方法和装置的选择性特征说明
图4和图5为一实施例,说明在一可变速率下输送一物质的一次性使用装置及其方法。图4为依实施例,说明在一可变速率下输送一物质的方法的流程图;图5为一概要的方块图,说明在一可变速率下输送一物质的一次性使用装置的实施例500。
依查找表(lookup table)决定时间延迟长度
在图5和图6所示的实施例中,在被激活后,输送速率可随因各种可变因子(variable factors)而变化。选择性地,可备一查找表,其包含一种或多种较佳的输送排程,举例来说,可依各种输送条件包含如下文说明依照一个或多个传感器的输出,选择一特定排程。
如图5和图6所示的实施例,可包含二个独立界面:一用户界面585及一编程介面543。
实施例500包含一可选择性安装的编程界面543,其可包含一通讯模块(communication cradle),例如在所述装置组装前,所述通讯模块可用于(programmingcontroller)551的编程;在某些实施例中,一无线连接(wireless connection)可用于控制器的编程。
在若干实施例中,编程界面543包含一通讯模块设置在已组装的装置上;例如,所述装置可被医疗人员或制造商的人员进行编程(元件符号402);装配所述编程界面至所述输送装置可以采用已知的连接器,例如一USB或一ZIGBEE连接器。
在若干实施例中,所述装置可包含一无线连接,连接一蜂窝网络(cellularnetwork),当发生故障时,通知(notification)可以被送达至医疗的接受者、及/或照顾者(例如护士或家人)、及或医师。上述的通知420可包含如下一种或多种情况:
一个声音通知,例如閙钟或合成的语音讯息;
一个闪光(例如一发光二极管(LED);
一个显示器上的书面讯息;
一个显示器上的象征讯息(例如一图标(icon);
一条通过无线连接的短信(例如通过一远程控制单元或一通过无线网路的SMS;
一条通过无线连接的非文字短信。
在若干实施例中,编程界面543可仅供专业编程人员(professional programmer)使用。可选择性地,独立的用户界面585可供接受者或其照顾者使用。
在若干实施例中,用户介面585非常简单,一个简单的用户界面585可以避免接受者及/或其照顾者遭受意外或灾祸。选择性地,简单的用户介面585可包含一激活器及/或一疼痛按钮(pain button)(例如当接受者感觉疼痛时,可按下所述疼痛按钮以降低输送速度及疼痛程度)。选择性地,简单的用户介面585可包含一发光二极管(LED)(例如一红光发光二极管,当发生故障时用于警告)及/或一液晶显示器用于显示简单的讯息。
在一实施例中,提供(元件符号410)一个预装配装置,所述预装配装置以可变的输送速率输送装置内物质。选择性的,提供410所述输送装置可包含一装填(元件411)药物至所述装置的步骤。实施例500包含一选择性的锁具机构563,避免所述输送装置或被输送的物质被篡改(tampering)。
在图4和图5示意的若干实施例中,所述输送装置被激活(元件符号412)及装配(元件符号414)到一需要的接受者身上(例如一需要用药的病患)。在若干实施例中,被活激412可接续在装配414之后,例如,可以先装配414至一接受者,接著再按下一按钮以激活412所述输送装置。
在图4所示意的若干实施例中,所述输送装置在被激活412后,等待(元件符号416)一可选择性的设定时间延迟;在若干实施例中,可不包含上述初始的等待416。
初步测试
选择性的,实施例500可包含一初步测试以确保所述装置完善地被装配且做好运作的准备。在若干实施例中,可包含一个或更多的测试或传感器在实施例500内。
经过等待416后,一选择性装配的传感器582测试(元件符号418)所述装置是否被正确地装配在接受者的皮肤上。举例来说,一装配的传感器可以包含以下一个或多个元件:
一光学传感器,例如当装置被完善地装配时,所述光学传感器会被皮肤屏蔽且无法感测到光线;
一个温度传感器用于感测体温;
一电阻传感器,例如当装配时,二个自所述装置表面延伸的电极接触所述接受者的皮肤,若二个电极间的电阻值介于人体皮肤的电阻值,则可确认所述装置被正确装配;
一压力传感器。
若所述装置没有被完善地装配418,则使用者(例如所述接受者及/或其照顾者)会被通知(元件符号420);在本实施例中,使用者可以重装(reattach,元件414)所述装置,在若干实施例中,装配不良会导致错误且需要一监管者重新激活所述装置。
在若干实施例中可包含一电源供应器562。在本实施中,电源供应器包含一个或多个电池。一个选择性装配的电源温度传感器574确认电池的温度(元件符号422),当电池的温度422超过可接受的值,所述装置等待416被校正。选择性的,若电池的温度过高,所述装置可通知使用者已发生故障。若电池的温度是在可接受的范围内(例如10℃到40℃)之间,则可正常的输送。
在若干实施例中,在被激活412及或装配414时,一皮下注射针590插入病人;在若干实施例中,在时间延迟结束前,不会把针插入(元件符号430’、433’)。一插入机构(insertion mechanism)559可以选择性地被一马达553驱动;选择性地,部署机构559可以被一装有弹簧的机构件或是一使用者(例如接受者、其照顾者或一医疗人员)所实施的外力所激活。
查找表示例
在实施例500中,把针590插入430’、433’及物质的输送是选择性地依赖一输送时程。在本实施例中,提供一包含多种可选输送时程的查找表572,可依照一个或多个传感器的输出,选择一输送时程。
在本实施例中,输送时程是依照量测(元件符号424)所述物质的温度而选择。举例来说:
若所述物质的温度低于3度℃(元件符号426),则输送会被延迟直到温度上升;选择性的,举例来说可用一化学加热器加热(元件符号428)所述物质。
若所述物质的温度等于或高于3℃(元件符号426),但低于10℃(元件符号426’),则所述查找表572输出一第一输送排程(元件符号432’)。
若所述物质的温度大于10℃,但于低于40℃(元件符号426”),则所述查找表572提供一第二输送排程(元件符号432”)。
若所述物质的温度大于40℃(元件符号426”),则输送排程可选择性地延迟(元件符号416’),且可选择性地通知使用者发生高温异常。使用者可确认引起异常的原因(例如所述输送装置被放置于太阳下,及/或所述接受者发烧)。
举例来说,在第一输送排程432’中,输送(元件符号434)可以起始于一缓慢而随时间增加的速度(让被输送的物质回温)。在本实施例中,第二输送排程432”是以最大速率进行输送434。在若干实施例中,输送434持续直到预定注入的10毫升液体输送完毕(元件符号436)。
使用者控制注射速度(user control of injection speed)
在本实施例中,使用者可以控制输送所述物质的速率。举例来说,所述使用者介面585可选择性地包含一速度按钮438及一疼痛按钮446,在输送的过程中,当使用者按下速度按钮438时,所述装置会检查当下的输送速率;若当下的输送速度低于最大速率(元件符号442),则输送所述物质的速率会被增加(元件符号444);若已达最大速率,则会忽略所述速度按钮。在若干实施例中,所述最大速率可以是一固定值(例如皮下注射(intradermalinjection)的最大速率界于每小时50到100毫升之间),且/或所述最大速率可以是依一较佳速率的百分比而定(例如最大速率界于所述较佳速度的百分之150到200之间)。
在输送所述物质的过程中,当使用者按下疼痛按钮(元件符号446)时,所述装置会检查当下的输送输率,若当下的输送速度高于最小速率(元件符号448),则输送所述物质的速率会被减速(元件符号450);若已达最小速率448,则会忽略所述疼痛按钮。在若干实施例中,所述最小速率可以是一固定值(例如皮下注射(intradermal injection)的最小速率界于每小时5到20毫升之间)且/或所述最小速率可以是依一较佳速率的百分比而定(例如最小速率界于所述较佳速度的百分之20到50之间)。
控制器及马达驱动器
实施例500包括一控制器处理器570。例示的实施例中,处理器570控制物质的输送速率。实施例500中,控制器551调控所述输送装置的激活。例示的实施例中,控制器551包括选择性的组件::例如一随机存取内存594,一实时钟596,及一振荡器599。若干实施例可能选择性包括一或多个此等组件。实施例500包括一马达驱动器555。例示的实施例中,控制器551使用脉冲宽度调整控制马达553。实施例500包括一选择性的电压调节器541。当电源562的电压变动时,电压调节器541确保电压源562的电压变动时输入至控制器551的输入电压持续稳定。
若干实施例可能包括一替代的马达及驱动机构。举例而言,若干实施例可能包括一步径马达以取代或连同DC马达及PWM驱动器。
例示的实施例中,马达553运转一释出机构、泵557。可选择地,泵557造成储槽588内部压力。当储槽588开封(例如在藉由开封机构592刺穿密封564后),压力可能使液体由储槽588释出通过皮下注射的针590并输送434至接受者。
若干实施例中,泵557可包括一选择性的具有活塞的注射筒。若干实施例中,泵557可能由其他机构,例如加压材料的释放及/或材料的膨胀及/或弹性材料的挤压所驱动。
去激活
例示的实施例中,当输送完成436,使用者被通知420’医药的输送完成。例示的实施例500包括可选择的去激活机构561。于输送后,去激活机构561使输送装置去激活。选择性地去激活可防止不当的再使用。例示性的实施例500,去激活机构561选择性包括保护456针590免于意外的针刺。
若干实施例中,在输送434结束后,针590将受到保护456。可选择地,保护456可以是自动的及/或使用者某些動作的结果。举例而言,若干实施例中,由使用者将装置移除454将触发针的保护456。若干实施例中,针可能留在接受者中以备再次的药物输送。若干实施例中,针可能被缩回及/或弯折及/或折断及/或盖住。
例示的实施例,在一次性使用后,一旦物质全部输送后,使用者将所述装置弃置460为城市垃圾。
预料在一专利的存活周期中,随著应用的成熟将发展出相关的技术,及所述用語的范围意图包括所有新技术。
此处提到的用语“约”意指±10%。
用语“包含”、“包括”、“具有”,及其变化意指“包括但不限于”。
用语“由…组成”意指“包括及限于”。
用语“实质上由…组成”意指组成物、方法或结构可能包括额外的成份、步骤及/或元件,但仅在所述额外的成份、步骤及/或元件不会实质改变请求的组成物、方法及结构的基本的及新颖的特征。
除非文中另有声明,用于本文的冠词“一”、“此”及“所述”包含复数的情形。举例而言,用语“一化合物”或“至少一化合物”可能包括多个化合物,包括其混合物。
贯穿全文,本申请案的各种实施例可能以范围的形式表示。应当理解的是以范围形式的描述仅是为了方便及简明,但不应解释为不容变更的限制本申请案。因此,范围的描述应视为具体揭露所有可能的次范围及在其中的个别数值。举例而言,范围的描述例如从1至6应视为具体揭露子范围例如:从1至3,从1至4,从1至5,从2至4,从2至6,从3至6等,以及此范围中的个别数值,例如1,2,3,4,5及6。此应用不论范围的宽广。
當本文中指出数值范围,意指包含在指出范围中的任何计载的数值(分数或整数)。用词“范围/介于”第一个指出的数字及第二个指出的数字及“范围/从…至”此处使用的第一个数字“至”第二个指出的数字可互换且意指包括第一及第二个指出的数字及所有介于之间的分数及整数的数值。
可以理解的是,为了说明起见,本申请的某些技术特征分散在多个实施例中,可以结合这些技术特征在同一实施例中;反过来说,为简洁起见,本申请案在同一实施说明的多个技术特征,可以分开在多个适当的实施例或以其他子结合的方式说明。在多个实施例中说明的若干技术特征不必然是必要技术特征,除非不具所述些技术特征会造成所述实施例失效。
Claims (23)
1.一种药物输送装置,包括:
一温度敏感组件;
一温度传感器,与温度敏感组件热连通,用于感测所述温度敏感组件的温度;
一经皮肤器;
一释出机构,装配于所述经皮肤器,以通过所述经皮肤器输送药物;及
一处理器,用于控制所述释出机构,使所述释出机构根据所述温度敏感组件的温度在开始输送药物前停滞一段固定时间的延迟,及根据所述温度敏感组件的温度在开始输送药物前调整所述固定时间的延迟。
2.如权利要求1所述的药物输送装置,其特征在于,所述温度敏感组件为药物。
3.如权利要求1所述的药物输送装置,其特征在于:所述温度敏感组件为供应所述药物输送装置的电源。
4.如权利要求1所述的药物输送装置,其特征在于,还包括:一储药槽,其中含有药物。
5.如权利要求1所述的药物输送装置,其特征在于,所述温度敏感组件为一储药槽。
6.如权利要求1所述的药物输送装置,其特征在于,所述处理器根据所述温度传感器的输出,控制所述药物的输送速率。
7.如权利要求1所述的药物输送装置,其特征在于,还包括:装配于所述处理器上的内存。
8.如权利要求7所述的药物输送装置,其特征在于,依据所述温度传感器的输出及编程于所述内存中的指令,所述处理器经由所述释出机构控制药物的输送速率。
9.如权利要求7所述的药物输送装置,其特征在于,还包括:装配于所述内存的编程界面。
10.如权利要求1所述的药物输送装置,其特征在于,还包括:一装配于所述经皮肤器的插入机构,并经由所述处理器控制,用于插入所述经皮肤器。
11.如权利要求1所述的药物输送装置,其特征在于,还包括:一装配于所述处理器的插入机构,用于在所述固定时间的延迟后,插入所述经皮肤器。
12.如权利要求1所述的药物输送装置,其特征在于,还包括:一去激活机构,在输送所述药物后使所述装置去激活。
13.如权利要求12所述的药物输送装置,其特征在于,所述去激活机构从所述释出机构输送一处方量的所述药物后,使所述装置去激活。
14.如权利要求1所述的药物输送装置,其特征在于,还包括:一锁具机构,用于防止所述药物输送装置受到窜改。
15.如权利要求1所述的药物输送装置,其特征在于,还包括:一用户界面,用于降低或增加所述药物输送的速率。
16.如权利要求15所述的药物输送装置,其特征在于:所述用户界面增加所述药物输送速率达到200%。
17.如权利要求15所述的药物输送装置,其特征在于,所述用户界面增加所述药物输送速率至50%。
18.如权利要求1所述的药物输送装置,其特征在于,还包括:一加热器,用于加热所述装置之至少一组件或所述药物。
19.一种药物输送装置,包括:
一温度敏感组件;
一温度传感器,用于感测所述温度敏感组件的温度;
一经皮肤器;
一释出机构,用于通过经皮肤器输送一药物;
一储药槽,用于将储存药物于其中;及
一处理器,用于控制所述释出机构,在激活所述释出机构前使所述释出机构根据所述温度敏感组件的温度在开始输送药物前停滞一固定时间延迟,以及根据所述温度敏感组件的温度在开始输送药物前调整所述固定时间。
20.如权利要求19所述的药物输送装置,其特征在于:所述温度敏感组件为所述药物、所述储药槽或所述药物输送装置的电源中至少一者。
21.如权利要求19所述的药物输送装置,其特征在于:所述固定时间延迟的长度为用于使所述温度敏感组件达到适当工作温度的预估时间。
22.如权利要求19所述的药物输送装置,其特征在于,还包括:一装配于所述处理器上的去激活机构。
23.如权利要求22所述的药物输送装置,其特征在于:所述去激活机构用于使所述药物输送装置去激活,所述去激活包括保护针、预备将所述装置弃置、或使所述装置永久无效至少一项。
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2012
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- 2012-08-14 CN CN201280068544.0A patent/CN104245014B/zh active Active
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US10335545B2 (en) | 2019-07-02 |
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WO2013115843A1 (en) | 2013-08-08 |
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