CN101264357A - 经皮给药装置 - Google Patents

经皮给药装置 Download PDF

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CN101264357A
CN101264357A CNA2007101995356A CN200710199535A CN101264357A CN 101264357 A CN101264357 A CN 101264357A CN A2007101995356 A CNA2007101995356 A CN A2007101995356A CN 200710199535 A CN200710199535 A CN 200710199535A CN 101264357 A CN101264357 A CN 101264357A
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piercing element
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克里斯托弗·J·弗莱厄蒂
约翰·T·加里博托
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Insulet Corp
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
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    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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    • AHUMAN NECESSITIES
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    • A61M2205/35Communication
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    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/01Remote controllers for specific apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body

Abstract

一种经皮给药装置,包括:确定出一贮存器的外壳;入口阀,从外壳的外部可以进入并且与贮存器连接;皮下输液套管,其从外壳中伸出,与贮存器流体相通并包括一末端尖端;以及皮肤穿刺元件,其位于输液套管内,并可在收缩位置和扩张位置之间移动,处于收缩位置时穿刺元件的尖锐尖端包含在装置内,处于扩张位置时穿刺元件的尖锐尖端从套管的末端尖端伸出。

Description

经皮给药装置
本申请是申请日为2001年11月9日、申请号为01821832.6、发明名称为“经皮给药装置”的中国专利申请的分案申请。
相关申请的交叉引用
本发明申请对2000年11月9日提交的临时美国专利申请60/247,598要求优先权,该申请被转让给本申请的受让人,并且其内容在此被结合。本专利申请与2001年8月31日提交的美国专利申请09/943,992相关,该申请被转让给本申请的受让人,并且其内容在此被结合以作参考。
技术领域
本发明一般地涉及输送治疗流体的装置,尤其涉及小型的、一次性的便携式输液装置和方法,用于将流体安全地和简单地经皮输送给哺乳动物患者。甚至更特别地,本发明涉及一种经皮输液装置,其允许将软套管安全并自动地经皮放置,而且不需要处理尖锐的和污染的针头。
背景技术
现在,大量的疾病和其它的身体不适需要使用各种药物进行治疗,包括固体或液体形式的药品、营养处方、生物衍生或活性制剂、激素和基因类物质和其它物质。在这些药物给药时,常常需要绕过哺乳动物患者的消化系统,以避免由消化道和肝脏内的催化酶引起的活性成分的降解。除了借助肠道给药的方式外,公知的其它给药方式是肠胃外给药。常常需要各种液体形式的药物的肠胃外给药,以便增强被输送物质的作用,保证未发生变化的药物以足够的浓度到达所需要的位置。并且,可以避免与其它给药途径相关的不需要的副作用,例如系统毒性。
通常,药物仅可能以液体形式获得,或者液体药物可以具有固体或药丸形式的药物所不具备的所需特性。液体药物的最佳给药方式可以是通过静脉或动脉直接输入到心血管系统,输入到皮下组织或直接输入器官、瘤、腔、骨骼或其它位置-身体内的特殊位置。
将液体药物肠胃外给药到体内常常是通过使用针头和贮存器的药丸注射来完成,或者通过重力驱动的分配器或经皮片技术连续进行。药丸注射常常不能很好地满足患者的临床需要,并且通常需要比给定的特殊时刻所需的剂量更大的单独剂量。通过重力输送系统的药物连续给药综合考虑患者的活动能力和生活方式,并将治疗限制在过分简单化的流率和方案。经皮片对被输送的药物有特殊要求,特别是当与单分子结构相关时,并且与重力输送系统相似,给药药物的控制受到严格限制。
已经开发了移动的输液泵,用于将液体药物输给病人。这些输液装置能够提供复杂的流体给药方案,从而实现药物要求、连续输液和不同流率给药。这些输液能力通常达到药物的更好效果和治愈,并对病人本身造成很小的毒性。作为使用移动输液泵的例子,是输送胰岛素治疗糖尿病。这些泵能在连续基线基础上以及药丸基础上输送胰岛素,如同Schneider等人在美国专利4,498,843中描述的。
移动泵常常与装液体药物的贮存器一起使用,如药筒或贮存器,并使用机电抽送或计量技术,以便通过管道将药物从输液装置输送到经皮插入的或穿过病人皮肤的针头中。通过位于装置外壳上并可以被病人或医生触动的机电按钮或开关对装置进行控制和编程。装置包括利用文本或图形屏幕的可视化反馈,例如称为LCD的液晶显示器,并可以包括报警或警示灯和声音或振动信号和警报。装置可以装在病人的吊带或衣袋中或缚于病人的身体上。
当前可以获得的移动式输液装置价格高,难以编程和用于输液,并且体积大、重量大并且易碎。填充这些装置是困难的,并需要病人同时携带所需的药物以及填充用具。该装置需要特别的保养、维护和清洁,以保证在所需的长期使用中的合适功能和安全性。由于当前装置的价格高,所以保健提供者限制了可以使用装置的病人数量以及使用此装置所能进行的治疗。
因此很明显,需要可编程的和可调节的输液系统,其能精确和可靠地工作,为临床医生和病人提供小型的、低成本的、重量轻的、使用简单的液体药物肠胃外给药的装置的替代物。
由此,本发明申请的申请者提供一种小型的、低成本的、重量轻的、使用简单的、为病人输送液体药物的装置,参见2001年8月31日提交的未授权的美国专利申请90/943,992。该装置包括出口、使液体从贮存器流到出口的分配器、编程后根据单独的遥控装置的流动指令使流体从流到出口的本地处理器以及与本地处理器连接用于接收流动指令的无线接收器。为了减小装置的大小、复杂性和成本,装置所具有的外壳没有用于向本地处理器提供流动指令的用户输入元件,例如键盘。
另外需要的是新型和改进的装置,用于将流体输送到病人。优选地,流体给药装置应当设计简单,价格低,并易于制造,并进一步减小装置的尺寸、复杂性和成本,从而使得装置或装置的一部分本身具有小型和不回收的属性。
另外,优选地,流体给药装置应包括允许软套管安全和自动地经皮放置的经皮输液装置,并且不需要处理尖锐的、污染的针头。
发明内容
本申请人确定,编程后能可靠地输送不同流动特征的液体药物,并且是小型的、重量轻的和低成本的复杂移动型输液装置是需要的。为了使移动型输液治疗被广泛接受,必须避免昂贵的长期使用装置所需的基本维护和保养费用。较小的和较轻的装置易于携带并且使病人更加舒适,甚至允许装置像经皮片一样用粘结剂粘贴在病人皮肤上。
通过减少健康保险提供者、医院和病人保健中心以及病人本身的经济负担,便宜的装置使得在指定该装置时具有更大的灵活性。另外,低成本的装置使病人可以具有一套或多套易于获得的替换装置,因此对于病人更加实用。如果原来的装置丢失或失效,替换装置的可用性去除了昂贵的加急修理并且避免了不连续的移动治疗周期。
因此,本发明提供了一种小型、重量轻和低成本的流体给药装置,其能够调节和可编程流体输送,并包括围绕贮存器室的外壳。与贮存器室流体相通的是分配器,用于从贮存器中以有限的数量分送流体。分配器是由液化给药装置的电子微控制器(称为“本地处理器”)控制。流体给药装置还包括从遥控装置接收信息的通讯元件,遥控装置不是机械地连接在本发明的流体给药装置上。还包括与分配器流体相通的出口组件,液体药物由此处流出流体给药装置并经皮进入哺乳动物患者的体内。
可以通过本发明流体给药装置输送的液体类型包括:胰岛素、抗生素、营养流体、全肠胃外营养或TPN、止痛剂、吗啡、激素或激素药物、基因治疗药物、抗凝血剂、止痛剂、心血管药物、AZT或化学疗法,但不限于此。可以应用本发明流体给药装置进行治疗的医学病症类型包括:糖尿病、心血管疾病、疼痛、慢性疼痛、癌症、AIDS、神经疾病、Alzheimer病、ALS、肝炎、帕金森病或痉挛等。
流体给药装置的外壳优选地没有机电元件,例如开关或按钮,使病人可以通过按动对流体给药装置进行编程或改变程序。流体给药装置与使用者之间的主要连接是通过遥控装置。
装置还包括穿过病人皮肤放置集成的输液装置以及自动抽回半刚性穿刺元件的装置。本发明的系统能避免在插入皮肤之前或从皮肤抽回装置之后需要尖锐的金属物体曾经暴露的过程。
本发明的另一个方面包括改进的经皮输液装置,它利用刚性或半刚性的穿刺元件将软的套管穿过病人的皮肤。接着穿刺元件可以从软的套管中取出,通过避免尖锐的刚性或半刚性的尖端停留在病人的皮下组织从而为病人提供更好的舒适性。
在一个方面中,穿刺元件能从皮下组织中抽回,但仍密封在本发明的输液装置中。连接在穿刺元件上的收缩装置是可分开的和取出的,留下污染元件的尖端安全地包含在装置中。改进的输液装置能保持留置一段时间,例如三天,使软的套管安全地位于病人的皮下组织中,在留置期间允许多次注射,而不需要用针头反复刺入皮肤。
在应用于例如I型糖尿病时,使用注射器注射的病人目前为了注射以及血糖测试需要穿刺他们的皮肤。随着无针头血糖技术的应用,无针头皮下进入装置,例如那些本发明中描述的,是非常有用的。
本发明的另一个方面包括具有流动限制元件的输液装置,它能防止输送到病人的流动速率或压力过大。通过与弹性的适应性部分相结合,系统能短期和长期贮存药物,并通过流动限制元件连续输送液体药物。
参考附图并结合以下的详细描述和实施例,可以更好地理解本发明的这些方面及其它的特征和优点。
附图简介
图1是第一代表性实施例的透视图,表示根据本发明制造的并且图中固定在病人上的流体给药装置,以及与流体给药装置一起使用的遥控装置(为了图示,将遥控装置相对于病人和流体给药装置进行了放大);
图2是图1中流体给药装置的剖视图,其中示出可滑动移动的穿刺元件,并且展开皮下输液套管;
图3是图2的圆圈3中的流体给药装置的部分穿刺元件和皮下输液套管的放大剖视图;
图4是图1中流体给药装置的剖视图,其中具有可滑动移动的穿刺元件,图中缩回皮下输液套管的内腔;
图5是图4的圆圈5中的流体给药装置的部分穿刺元件和皮下输液套管的放大剖视图;
图6是本发明流体给药装置另一个实施例的剖视图,其中可滑动移动的穿刺元件离开皮下输液套管;
图7是图7中的圆圈7中的流体给药装置的部分穿刺元件和皮下输液套管的放大剖视图;
图8是本发明流体给药装置另一个实施例的剖视图,其中示出穿刺元件在刺入前位于皮下输液套管中;
图9是图8中的圆圈9中的流体给药装置的部分穿刺元件和皮下输液套管的放大剖视图;
图10是图9中流体给药装置的顶视平面图,示出了装置的针头位置指示器;
图11是图8中流体给药装置的剖视图,其中穿刺元件位于皮下输液套管的尖端的远方;
图12是图11流体给药装置的顶视平面图,表示针头位置指示器;
图13至图17是定位在病人皮肤上的本发明流体给药装置另一个实施例的剖视图,表示展开前、展开中和展开后的穿刺元件;
图18是本发明流体给药装置另一个实施例的剖视图,表示定位于病人皮肤上;
图19是本发明流体给药装置另一个实施例的剖视图,表示定位于病人皮肤上;
图20是图19中装置的顶视平面图;
图21是图19中流体给药装置的剖视图,其中穿刺元件在图中已经拉回并且去除了收缩装置;
图22是本发明流体给药装置另一个实施例的剖视图,表示穿刺元件和展开的输液套管以及连接到装置上的收缩器;
图23是图22中装置的剖视图,示出了缩回到装置中的穿刺元件、展开的输液套管以及分离的收缩器;
图24是本发明流体给药装置另一个实施例的剖视图,示出了穿刺元件和展开的输液套管以及连接到装置上的收缩器;
图25是图22的剖视图,示出了缩回到装置中的穿刺元件、展开的输液套管以及分离的收缩器;
图26是本发明流体给药装置另一个实施例的顶视平面图;
图27是本发明流体给药装置另一个实施例的剖视图;
图28是本发明流体给药装置另一个实施例的剖视图;
图29是本发明流体给药装置另一个实施例的顶视平面图,其中局部剖视;
图30是图29装置的剖视图,表示正好将装置的穿刺元件刺入病人皮肤之前;
图31是图29装置的剖视图,与图30的视图相比旋转90度,示出刺入病人皮肤并进入皮下组织的穿刺元件和皮下输液套管;
图32是图29装置的顶视图,其中局部剖视,示出了穿刺元件已去除;
图33是图29装置的剖视图,表示套管仍在皮下组织中展开;
图34是本发明流体给药装置另一个实施例的顶视平面图,其中局部剖视,并示出了适应区未扩张;以及
图35是图34装置的顶视平面图,其中局部剖视,并示出了适应区完全扩张并被约束元件限制。
具体实施方式
首先参看图1和2,图中表示根据本发明制造的流体给药装置10。能被本发明流体给药装置给药的流体类型包括:胰岛素、抗生素、营养流体、全部肠胃外营养或TPN、止痛剂、吗啡、激素或激素药物、基因治疗药物、抗凝血剂、止痛剂、心血管药物、AZT或化学疗法,但不限于此。可以应用本发明流体给药装置进行治疗的医学病症类型包括:糖尿病、心血管疾病、疼痛、慢性疼痛、癌症、AIDS、神经疾病、Alzheimer病、ALS、肝炎、帕金森病或痉挛等。
参看图2,装置10一般包括具有经皮刺入病人工具的出口组件70,使流体从贮存器30流到出口组件70的分配器40,以及与分配器40连接的处理器或电子微控制器(此后称之为“本地处理器”)50。
本地处理器50编程后,根据来自单独的遥控装置100的流动指令,使流体流动到出口组件70,遥控装置100的一个例子示于图1中。再看图2,流体给药装置10还包括无线接收器60,它与本地处理器50连接,用于接收来自单独的遥控装置100的流动指令,并将流动指令传送到本地处理器。装置10还包括含有出口组件70的外壳20、贮存器30、分配器40、本地处理器50和无线接收器60。
如图所示,外壳20没有用户输入元件为本地处理器50提供流动指令,例如外壳外表面21上的机电开关或按钮,或者没有另外可为用户访问的、通过本地处理器50调节编程的流动速率的界面。没有用户输入元件使装置10的大小、复杂性和成本大大降低,因此本质上装置10本身是小型的和可丢弃的。
为了编程,调整程序,或者将用户输入传送到本地处理器50,流体给药装置10包括无线通讯元件,或接收器60,用于从图1中单独的遥控装置100接收用户输入。信号可以通过遥控装置100的通讯元件(未图示)发送,通讯元件包括天线130或者连接到天线130,如图1所示,天线130在装置100的外部。
参看图1和2,遥控装置100具有用户输入元件,它包括机电开关阵列,如图中所示的薄膜按键120。遥控装置100还包括用户输入元件,它包括可视显示器,例如液晶显示器(LCD)110。另外可供选择的是,控制装置可以具有触摸屏,同时用于用户输入和输出。尽管图1中未图示,但是遥控装置100还包括它本身的处理器(此后称之为“远程”处理器),其与薄膜按键120及LCD110连接。远程处理器从薄膜按键120接收用户输入,并发出“流动”指令传送到流体给药装置10,并将信息输出到LCD110。由于遥控装置100还包括可视显示器110,因此流体给药装置10可以没有信息屏幕,进一步减小了装置10的大小、复杂性和成本。
装置10的通讯元件60优选地使用无线电频率或其它无线通讯标准和协议与遥控装置100进行电子通讯。在一个优选的实施例中,通讯元件60是双向通讯元件,包括接收器和发射器,允许流体给药装置10将信息发送回遥控装置100。在这个实施例中,遥控装置100还包括具有接收器和发射器的集成通讯元件60,使遥控装置100接收流体给药装置10发送的信息。
装置10的本地处理器50含有允许用户对所需流动方案编程和根据需要调整程序所需的所有计算机程序和电路。此电路包括本领域一般技术人员公知的一个或多个微处理器、数字和模拟集成电路、电阻、电容、晶体管及其它半导体和其它电子元件。本地处理器50还包括以所需的时间间隔恰当地驱动分配器40的程序、电路和存储器。
在图2中的代表性实施例中,装置10包括电源80,例如电池或电容,用于为本地处理器50提供电源。电源80优选地集成在流体给药装置10中,但可以是可更换的,例如可更换的电池。
尽管未图示,但装置可包括传感器或变送器,例如贮存器容积变送器或贮存器压力变送器,用于将信息传送到本地处理器50,以指示如何和何时启动分配器40,或者指示确定流动的其它参数,泵流动通道的初始条件,流动通道的堵塞,接触传感器,旋转运动或其它运动指示器,以及诸如贮存器30排空或泄露的情况、或者从贮存器分配太多或太少流体等。
选择贮存器30的容积,以便最好地适应流体给药装置10的治疗用途,这受以下因素影响:所输送的药物流体的可获得浓度,重新充满流体给药装置10之间的或者丢弃流体给药装置10之前的可接受时间,尺寸限制以及其它因素。贮存器30可以由装置制造商或协作的药物制造商预先充满,或者可以包括外部的填充装置,例如具有针头插入隔膜或Luer接头的填充口。另外,装置10可以具有可移动的贮存器。
尽管未图示,装置10还可在外壳20的外表面上具有粘结剂层,用于将装置10直接固定到病人皮肤上。粘结剂层优选地形成包围出口组件70的连续环,以便对穿刺皮肤周围提供保护性密封。外壳20可以由柔性材料制成,或者具有柔性的铰接部分,从而允许流体给药装置10在病人运动过程中弯曲,以防止脱落并使病人舒服。
分配器40与贮存器30流体相通,如图2所示,并受本地处理器50控制,本地处理器50包括电子程序、控制和电路,允许对分配器40进行复杂的流体给药编程和控制。当装置10具有加压的贮存器30时(即贮存器内的流体压力保持在高于大气压的压力),分配器40的设计是作为计量装置,允许流体脉冲从加压贮存器30,经过分配器40,流到大气压下的出口组件70。当装置10具有不加压贮存器30时,分配器40的设计是对从其中通过的流体产生驱动或抽送力。
现在参看图2到5,本发明提供一种改进的出口组件70,作为流体给药装置10的一部分。出口组件70一般包括从分配器40伸出的柔性经皮套管703和位于套管内的刚性穿刺元件704。穿刺元件704用于驱动套管704穿透病人皮肤并进入病人的皮下组织,然后抽回使软套管703留在皮下组织中的合适位置上。改进的出口组件70避免了处理尖锐的污染针头,以及在使用装置10的整个过程中病人受到尖点作用。
柔性经皮套管703可以由与输送的液体药物相容的多种材料制成,例如硅酮、聚氯乙烯、聚乙烯或尼龙。穿刺元件704可以由金属制成,例如不锈钢。如果需要柔性的穿刺元件704,则可以使用弹簧钢或弹性金属,例如镍钛合金,也称为Nitinol。
出口组件也包括穿刺元件704,穿刺元件704具有尖锐的末端尖,具有半刚性结构并能退出经皮输液套管703,以便在放置过程中帮助刺穿病人皮肤。穿刺元件可以由具有弹性特性的弹簧钢或镍钛合金Nitinol制成。在图1的流体给药装置10的结构中,穿刺元件704在其允许的行程中需要弯曲或者修改其形状。在一个优选的实施例中,穿刺元件具有内腔,允许流体在其外壁内流动。
穿刺元件704经由它所连接的连接元件702移动。由于穿刺元件704位于装置的流动通道内,因此远端线性扩张和收缩元件710D的一端连接到经皮输液套管的近端,其另一端连接到连接元件702。近端线性扩张和收缩元件710P可以其一端连接到连接元件另一侧,在其另一端连接到与分配端40相连的流体流动管。所有连接允许流动通过,同时防止在连接点处泄露。
如图2和3所示,近端线性扩张和收缩元件710P及远端线性扩张和收缩元件710D是管,其结构允许管的一端线性位移,而另一端位移不同的距离或根本没有位移。由柔性材料制成的风箱或手风琴结构能满足此需要。选作近端线性扩张和收缩元件710P和远端线性扩张和收缩元件710D的材料可以包括硅酮、聚乙烯、聚氯乙烯、尼龙或与其它材料,这些材料与被输送流体相容,是柔性的,并能制成手风琴结构。
当如上所述制造和组装,并且穿刺元件在外壳20内处于缩回位置时,穿刺控制按钮701K能向前运动,推动连接元件702前进。当连接元件702向前移动时,穿刺元件704与其一起运动,而远端线性扩张和收缩元件710D缩回,这样,穿刺元件704滑动地在经皮输液套管703的内腔中移动,露出尖端。为了保持系统密封的流体连接,当连接元件702由穿刺控制按钮701K带动向前移动时,近端线性扩张和收缩元件710P伸展。或者,在缺少近端线性扩张和收缩元件710P时,连接元件702的管连接可以是柔性的并具有足够的长度以允许组件的运动范围。
图2和3表示穿刺控制按钮701K向前移动,穿刺控制弹簧705拉长,近端线性扩张和收缩元件710P扩张,远端线性扩张和收缩元件710D收缩,穿刺元件704伸出经皮输液套管703之外。
如果穿刺元件704已经伸出,如图2和3所示,穿刺控制按钮701K可以退回,相应地与穿刺元件704连接的连接元件702退回。柔性的经皮套管703仍保持在病人皮下组织中的合适位置上,因为移动被远端线性扩张和收缩元件710D吸收。
在本发明优选的实施例中,穿刺控制按钮701K连结在穿刺控制弹簧705上,穿刺控制弹簧705偏压穿刺控制按钮701K,只要穿刺元件704伸出,就会自动将穿刺元件704缩回。在使用过程中,病人将移动穿刺控制按钮701K以便使穿刺元件704伸出,将流体给药装置10放置在皮肤上,例如在腹部区域,用穿刺元件704和经皮输液套管703刺穿皮肤,并进一步用医用胶带将流体给药装置10固定在其身体上。在一个优选的实施例中,流体给药装置10可以包括粘结剂层201,例如围绕装置边界的粘结剂环,用于粘附到病人皮肤上。一旦病人松开穿刺控制按钮701K,由于穿刺控制弹簧705的偏压,穿刺元件704自动缩回,将软的输液套管、经皮输液套管703留在病人皮下组织的合适位置上。
如图2到5所示,穿刺元件704的外径约等于容纳它的流动管的内径,例如经皮输液套管703和远端线性扩张和收缩元件710D。由于穿刺元件704在缩回后仍保留在装置的流动通道内,因此流体流过穿刺元件704的内腔,到达经皮输液套管703的远端尖端。在另一个实施例中,穿刺元件704的外径小于容纳它的流动管,使流体在穿刺元件704周围流动,因此不需要穿刺元件704中具有内腔。
图4和图5示出图1中的流体输送装置10,表示松开穿刺控制按钮701K并且穿刺控制弹簧705处于未储存势能的静止状态。另外,近端线性扩张和收缩元件710P在图中是收缩的,远端线性扩张和收缩元件710D是展开的,穿刺元件704缩回到外壳20和经皮输液套管703的腔内。
参看图6,本发明的流体给药装置10的另一个实施例,如图所示,具有实体的穿刺元件704,其外径小于远端线性扩张和收缩元件710D的内径,从而流体从穿刺元件704的周围流过。
从图7中可以更好看出,柔性经皮输液套管703,可以通过外壳出口20E从流体给药装置10的外壳20中伸出,并包括一个或多个侧孔706,从而流体能伸出套管的末端尖端以及靠近尖端的出孔。可以选择的是,末端尖端可以是密封的,迫使所有流体从一个或多个侧孔706中流出。
图8到10表示本发明流体给药装置10的另一个实施例,其具有连接到柔性管720P的可移动的中空穿刺元件704,穿刺元件704通过外壳出口密封20ES可滑动地连接到输液套管703。图8表示穿刺元件704处于缩回状态的流体给药装置10。
穿刺控制按钮701K连接到连接元件702,当作用在穿刺控制按钮701K上的力足够克服穿刺控制弹簧705的偏压时,将使连接元件702向前移动,穿刺元件704向前进一步通过外壳出口密封20ES,使穿刺元件704的末端尖端伸出柔软经皮套管703之外。当处于前进状态时,穿刺元件704和柔性经皮套管703能穿透病人的皮肤。接着松开穿刺控制铵钮701K,穿刺控制弹簧705的偏压使连接元件702和穿刺元件704缩回,从而穿刺元件704的尖端被拉回到柔性经皮套管703的内腔中,并拉入外壳出口20E。
穿刺元件704的近端与近端的流体输送管720P之间处于封闭的流体相通。近端流体输送管720P具有足够的长度和可变形性结构,用于支承穿刺元件704的全部行程。近端流体输送管720P是由柔性材料制成的,与被输送的选定流体是相容的。这些材料的例子包括硅酮、聚乙烯、聚氯乙烯、尼龙和其它材料。或者,近端流体输送管720P可以包括风箱或手风琴结构,例如图1所示的近端线性扩张和收缩元件710P。
图9表示穿刺元件704缩回外壳出口20E中,但仍穿过外壳出口密封20ES并留在柔性经皮套管703的腔中。图10是流体给药装置10的顶视图,其中包括针头位置指示器707,对于穿刺元件704的位置给用户一个可见的指示。穿刺控制按钮701K的顶部与针头位置指示器707中包括的文字或其它可见的指示相关,用于指示穿刺元件704的位置。图10与图8和9相关,其中穿刺控制按钮701K处于缩回状态,穿刺元件704缩回,针头位置指示器707指示缩回状态。
图11是本发明流体给药装置10的另一个实施例,其中包括与柔性管720P连接的可前移的穿刺元件704,柔性管720P与分配器40流体相通。图示的流体给药装置10具有处于完全前移状态的穿刺元件704。当处于前移状态时,穿刺元件704适于穿刺病人的皮肤。另外,在前移后,穿刺控制按钮701K通过按钮701K上的锁片被锁定在合适的位置,按钮701K与外壳20中的切口相配合,以便将穿刺元件704固定在其前移的位置上。
在图11所示的实施例中,穿刺元件704需要在前移过程中弯曲,形成适当的直角弯穿过外壳20的出口20E。因此,穿刺元件是由足以承受穿刺病人皮肤的材料制成,而且要具有充分的柔性,以便在前移和缩回的过程中弯曲。适合的材料的例子包括弹簧钢,以及被称之为Nitinol的镍钛合金。或者,可以设计成穿刺元件704仅沿垂直病人皮肤的方向移动,即上和下方向,并且近端流体输送管720P可弯曲。在这种设计中,穿刺元件704可以是刚性结构并由非柔性材料制成,例如标准等级或皮下注射等级的不锈钢。在两种结构中,穿刺元件704均是中空的,用于承载流体流动,并且可包括尖锐的尖端,以帮助穿刺病人的皮肤。
如图12所示,图11的实施例包括针头位置指示器707,它为用户就穿刺元件704的位置而提供可视的反馈。穿刺控制按钮701K的顶部与针头位置指示器707中包括的文字或其它可见的指示相关,用于指示穿刺元件704的位置。图12与图11相关,其中穿刺控制按钮701K处于伸出和锁定状态,穿刺元件704前移,如同针头位置指示器707的指示。
图13到17表示本发明流体给药装置10的另一个优选实施例,图中所示附着在病人皮肤210上,并且出口组件70包括穿刺控制按钮701B,它从外壳20的按钮间隙孔740中穿过,用于前移和缩回经皮穿刺元件704。穿刺控制按钮740沿垂直皮肤210的相反方向是可移动的,并固定地连接在连接元件702上。连接元件702具有连接近端流体输送管720P和远端线性扩张和收缩元件710D的流体通道,而近端流体输送管720P又连接到分配器40。所有连接都使各元件之间流体流动时没有泄露。远端线性扩张和收缩元件710D与远端流体输送管720D流体相通,远端流体输送管720D与柔性的经皮套管703流体相通。穿刺元件704处于远端线性扩张和收缩元件710D和柔性经皮套管703之中,并且固定地连接在连接元件702上。
在图13中,穿刺控制按钮701B处于初始的、未受压的位置,因此穿刺控制弹簧705完全收缩,柔性经皮套管703缩回到外壳出口20E中,穿刺元件704缩回到柔性经皮套管703中。图13还表示装置10通过粘结剂201附着在病人皮肤210上。图14表示,例如病人用手指(未图示),将穿刺控制按钮701B按入按钮间隙孔740中,并使近端流体输送管720P和远端流体输送管720D向前移向皮肤210,穿刺控制弹簧705伸长,穿刺元件704和套管703向前移到皮肤210的表面。图12表示进一步压入穿刺控制按钮701B,使近端流体输送管720P和远端线性扩张和收缩元件710D进一步向前移向皮肤,穿刺控制弹簧705进一步伸长,穿刺元件704刺入皮肤210并进入病人的皮下组织211。长的管状外壳出口20E支承柔性的经皮套管703和穿刺元件704,并提供额外的圆柱强度,以帮助刺入病人皮肤210的表面。
图16表示将穿刺控制按钮701B进一步压入铵钮间隙孔740,使穿刺控制弹簧705完全伸长,使近端流体输送管720P进一步前移,远端线性扩张和收缩元件710D与外壳出口20E接触,柔性经皮套管703前移穿过皮肤210并进入病人的皮下组织211,穿刺元件704进一步前移穿过皮肤210并进入皮下组织211。图17表示穿刺控制按钮701B释放后,穿刺控制弹簧705使按钮沿离开皮肤210的方向收缩并返回,回到按钮间隙孔740中,使穿刺元件704缩回到柔性经皮套管703和外壳出口20E中。但是如图所示,柔性经皮套管703仍穿过皮肤210并处于病人的皮下组织211中。
当穿刺元件704滑动缩回时,为了将柔性的经皮套管703保持在皮下组织211中并防止柔性经皮套管703缩回到外壳出口20E内,外壳出口20E具有粗糙的内表面与柔性的经皮套管703摩擦配合。或者,外壳出口20E的表面可以具有倾斜的未示出的摩擦配合元件,使柔性经皮套管703光滑地向皮肤210前移并阻止柔性套管703离开皮肤210的运动。
所有上述连接使流体在各个元件之间流动而不产生泄露。远端线性扩张和收缩元件710D允许穿刺元件704与柔性经皮套管之间相对运动的数量和方向可以不同,这形成本发明的优选实施例。另外,可以使用第二弹簧(未图示)提供自动插入力偏压,即朝向皮肤偏压。穿刺皮肤的速度是减缓疼痛的重要因素,而使用第二弹簧是有益的,这通过推动或转动穿刺控制按钮701B促动第二弹簧,并在穿刺元件704到达其行程最下端时松开第二弹簧实现。
图18表示本发明流体给药装置10的另一个实施例。图18的装置10包括覆盖在外壳20上的粘性膜205,用于将装置10粘贴到病人皮肤210上,并且具有突出204从外壳20上伸出。出口组件70集成在一个粘性轴突出204上并通过远端输送管720D连接到分配器40。出口组件70包括皮肤穿刺套管72,例如皮下注射针头或柔性套管,如上所述,它与远端流体输送管720D和套管插入隔膜76流体相通。套管插入隔膜76适于允许针头(未图示)穿过隔膜,同时隔膜保持密封,从而针头通过皮肤穿刺套72将流体注射到病人体内。当针头取走后,套管插入隔膜76密封针头穿刺区域。隔膜76处于压缩状态,例如使用一个压缩室(未图示),用于协助密封,隔膜由适合的材料制成,例如硅弹性橡胶。远端流体输送管720D可以包括单向止回阀(未图示),防止进入套管插入隔膜76的流体流回到分配器40。
图19表示本发明的经皮输液按钮200,它包括包围入口阀240的室220。室220可以由塑料或者金属制成,塑料如乙酰或聚砜,金属如不锈钢或钛。对于低成本的产品,优选注塑成形的塑料。入口阀240可以是机械阀,包括用于与标准注射器相接的Luer接头,未图示,或者是由诸如硅酮等材料制成的针头穿刺隔膜,如图所示。
在入口阀240下面由室220确定的是贮存器245。包围室220的是柔性部分225,它包括底面和底面上的粘结剂层201。连结在室220上的是与入口阀240流体相通的皮下输液套管260。在首次使用之前,经皮穿刺器250包含在皮下输液套管260的内腔中。在图示的实施例中,穿刺器250是中空的。连结在经皮穿刺器250的近端的是穿过入口阀240的可分离的收缩器230。装置的放置包括用经皮穿刺器250刺入病人皮肤210,直到外壳的粘结剂层201牢固接触在病人皮肤210的表面,并且皮下输液套管260停留在皮下组织211中。
图20是经皮输液按钮200的顶视图,表示包围外壳220和入口阀240的柔性部分225。柔性部分225是由柔性材料制成的,例如,硅弹性橡胶,并且允许病人的皮肤有相对移动。粘结剂201可以是标准的表皮粘结剂,例如那些在bandaids中使用的,或者那些被Tyco Valley Lab用于他们的电外科垫中的。
在图21中,可分离的收缩器230已经从皮下输液套管260内腔中的经皮穿刺器250中拉出,并从入口阀240中取出。当经皮输液按钮200位于合适的地方,并且收缩器230取出时,注射器和针头就可以通过入口阀240插入,以通过中空的经皮穿刺器250输送流体,并通过皮下输液套管260将流体输入皮下组织211。
经皮穿刺器250的外径大于皮下套管260的内径。皮下套管260的设计及其制作的材料允许皮下套管260在皮下穿刺器250周围的区域沿径向膨胀,并允许经皮穿刺器250可滑动地在皮下套管260中移动,当被可分离的收缩器230缩回时不引起可分离的收缩器230过早地离开经皮穿刺器250。可以使用润滑剂,例如Nusil公司或Dow公司的硅酮乳液,用于润滑皮下输液套管260的内表面,使经皮穿刺器250易于移动。较小内径的皮下输液套管260可以更容易被临床接受,较大外径的经皮穿刺器可以帮助装置的经皮穿刺。或者,经皮穿刺器250可以具有与皮下套管260的内径相似或稍小的外径。
图22是本发明包括经皮输液按钮200的另一个优选实施例,其中包括穿刺元件250和可分离的收缩器270,可分离的收缩器270用于将穿刺器收缩到装置中的一个位置。输液按钮200还包括外壳220,优选地由诸如乙酰的塑料注塑成形制成,以减轻重量并降低成本;以及顶面221和柔性部分225,柔性部分225围绕外壳并由软的柔性材料制成,例如硅酮弹性橡胶,从而可以弯曲并为穿戴按钮200的病人提供舒适性。按钮200的底面222包括粘结剂层201,用于将按钮粘贴到病人皮肤上。
按钮还包括具有入口隔膜241的入口阀240,入口隔膜241被隔膜环242环绕并径向压缩。入口隔膜241处于按钮200的贮存器243中。皮下输液套管260与入口阀240流体相通并且伸出外壳220的底部分。在放入病人之前,经皮穿刺器250的尖端251伸出皮下输液套管260的尖端。在经皮穿刺器250的近端是穿刺器密封元件252,用于当穿刺器缩回时形成流体密封。在经皮穿刺器250的近端还有固定孔254,收缩器270固定在其远端上。收缩器270经由分离出口224进入经皮输液按钮200。在收缩器270的近端是分开的抓持271,它伸出外壳220,并且在装置200经皮穿刺后被使用者拉动,以便将皮下输液套管260的腔中的经皮穿刺器250的穿刺器尖端251拉出。
如图23所示,经皮穿刺器250经过单独的分离出口224退出经皮输液按钮200,出口224的出口通道平行于病人皮肤,需要直角或近似直角的出口轨线。因此,经皮穿刺器250是由弹性材料制成,优选的是金属,例如镍、钛合金或弹簧钢。如图23所示,收缩器270能完全将经皮穿刺器250收缩到外壳内的出口224中,避免穿刺器存在于皮下输液套管260中或流体通道的任何部分。经皮穿刺器250可以为实体管或空心管。
图23表示经皮穿刺器250完全拉回,穿刺器密封元件252对输液按钮外壳220形成流体密封,从而防止输液过程中的泄露。如图所示,收缩器270与经皮穿刺器250分开,并被丢弃。收缩器270不包括任何的尖锐边缘,并不被体液污染,使得分开的收缩器的处理容易、安全和卫生。
图24表示经皮输液按钮200的另一个实施例,其中穿刺器250的末端尖端251是中空的并且包括至少一个侧向孔253。穿刺器250被改变,从而当穿刺器250被收缩器270拉回时,如图25所示,穿刺器250仍保留在输液套管260中。通过按钮200流入病人是通过流过穿刺器250的侧向孔253和中空尖端251实现的。
图26表示经皮输液按钮200的另一个实施例的顶视图,其中具有位于外壳220内的分离出口通道223,并在分离出口224退出。如图所示,分离出口通道223是一个迂回的路线,使未图示的分开元件或未图示的经皮穿刺器所具有的线性长度长于按钮200的横向尺寸,例如图26中所示按钮200实施例的半径。分离出口通道223的迂回路线使穿刺器较长并仍可完全从输液按钮200的流体通道中缩回。
图27表示本发明另一个优选的实施例,其中包括按钮泵组件400,它使非输入液(infusate)输送到单独的室,从而使所需的输入液输送到病人。与上述按钮200的结构相似,按钮泵组件400包括入口阀490,其具有被泵壳420包围的入口隔膜491,泵壳420又被柔性部分425包围并覆盖,柔性部分425包括壳顶面421。装置的按钮表面422包括粘结剂层401。
由按钮泵壳420确定的是贮存器430,它优选是圆柱形。伸出贮存器430底部的是皮下输液套管460,它可以是软套管或半刚性或刚性结构,例如针头。将贮存器430分成流体移动部分471和治疗部分472的是可移动的活塞470。当流体通过入口阀490加入移动贮存器部分471时,贮存器活塞470向输液套管460移动并通过套管从药物贮存器部分472排出等量的流体。
药物贮存器部分472可在分发给病人和保健提供者之前预先充满,或者包括药物贮存器入口管443,如图27所示。药物贮存器入口管443从药物贮存器入口阀442,例如针头穿刺隔膜,延伸到药物贮存器部分472的底部。装置可以充满特定数量的药物,接着当任何流体,例如水或盐水,通过入口阀490加入移动贮存器部分471时,贮存器活塞470将向下移动,迫使等量的治疗流体通过皮下输液套管460流出装置。按钮400的优点在于简化了药物给药过程,包括不需要病人单独地随身携带药物供应。简单的注射器,使用自来水,就能用于给出恰当数量的治疗药物,而自来水实际上根本不会进入病人,这是因为贮存器活塞470形成了流体密封。
应该意识到,前面图中的按钮200中所示的所有元件可以包括在图27的按钮泵组件400中。通过针头或者诸如标准Luer接头的机械连接可以允许进入入口阀。装置可以包括流动限制器,用于防止压力过高。另外,可以包括适应部分,或者皮下输液套管460可以是适应性的,并且在其内腔中包括流动限制器,从而流体在一段较长时间内积累并输送到病人,如上所述。可以包括穿刺元件,其具有出口通道和可能的收缩器,用于帮助皮下输液套管460的经皮放置。皮下输液套管460可以用不锈钢、Nitinol或适应性材料,如硅酮、聚氯乙烯、聚乙烯,或者其它材料制成。
图28表示另一个按钮泵组件400,它与图27中的装置相似,但包括两个单独的、柔性的、密封的贮存器440、450,它们彼此间机械相通,从而作用在或来自一个贮存器上的任何力相应地作用到另一个贮存器上。一定量的非输入液可以输送到非输入液贮存器450,使等量的治疗输入液从输入液贮存器440中输送到病人。与图27中装置的结构相似,按钮泵组件400包括具有隔膜491的入口阀490。
贮存器430中包含的是适应性移动贮存器膜451,它确定非输入液贮存器450,贮存器450通过止回阀452与入口阀490流体相通。用于扩张的空间453位于贮存器膜451和壳420之间,从而膜451能弹性地扩张并加压其中所含的非输入液。可以包括排出孔,使移动贮存器膜451不受阻碍地扩张。
在壳420的贮存器室430内包含的还有适应性膜441,它确定输入液贮存器440,贮存器440与皮下输液套管460相连。位于输入液贮存器440与皮下输液套管460之间的是流动阀480,它可以是简单的单向止回阀或较复杂的流动限制组件。
图29表示本发明另一个优选实施例的流体给药装置300,其中在装置的流体通道中包括流动限制元件380。装置300包括注射器套340,用于连接到标准Luer接头,例如那些包括在标准注射器上的。注射器套340包括注射器壳341和与标准阴Luer接头上的阴螺纹啮合的注射器套阳螺纹343。注射器套340包括止回阀344,用于控制进入皮下套管360的流体流动,皮下套管360的一部分被设计成处于哺乳动物患者的皮下组织中。如果注射器套340包括可穿刺的再密封隔膜,用于使针头进入,而不是适于连接Luer接头,则不需要止回阀344。
在流体给药装置300的流体通道内并靠近皮下输液套管360的末端尖端的是流动限制器380。流动限流器380包括微内腔,例如限流器微内腔380ML,可以限制每个Poissons方程的流动,但也可以具有更复杂的流动限制结构,例如渗透膜或其它半透屏障。微内腔380ML与输液套管360处于同一直线,或者包含很多弯的迂回路线,以达到限制流动所需的足够长度。皮下输液套管360可以附着在皮肤片310上,皮肤片310的一个侧面包括适当的粘结剂311。所包括的片套管连接区312用于将皮下输液套管360结合到皮肤片310上,并使皮下输液套管360的远端部分保持不结合,用于从皮肤片310上挠曲并进入病人皮肤。
流动限流器380的一个功能是限制套管360末端尖端处传递给病人的压力。这种过压状态可导致严重的不利结果,例如错位、外伤、容器损坏等。通过限制流动,流动限流器380产生明显的压力降,从而没有较大的压力达到并传递到皮肤上。
在流动限流器380近端的可以是适应性部分,例如,可膨胀的蓄液器350。可膨胀的蓄液器350是弹性的适应性组件,在其环境中或膨胀状态具有接近零的容积。可膨胀的蓄液器350被设计,使得当流体通过注射口340注射到装置中时,流体经过止回阀344并且流动限流器380提供足够的背压,使可膨胀的蓄液器350随着注射的流体膨胀。由此,膨胀的蓄液器350使其中的流体处于较高压力。经过一段时间,流体经过流动限流器380并且通过皮下输液套管360的末端尖端流出装置300。
根据可膨胀蓄液器350产生的压力以及流动限流器380的流动限制性能,能够确定所得到的输液的时间长度和流动特征。较低的压力和较大的限流将使输液在较长的时间内进行,与某些治疗中使用的标准注射器注射相比,例如使用胰岛素治疗糖尿病,这是很有益的。在另外的实施例中,皮下套管360可以由弹性的适应性材料制成,使位于流动限流器380近端的皮下套管部分起到蓄液器350的功能,从而不必需要额外的元件或材料作为蓄液器350。
如图29所示,流体给药装置300还包括经皮穿刺元件320,它从注射器套340、皮下套管360中通过,并伸出套管360的末端尖端。穿刺元件帮助皮下套管360的尖端穿过病人的皮肤并进入皮下组织。穿刺元件320可以从流动限流器380中通过或者也可以在其旁边经过。如果皮下套管360由弹性的适应性材料制成,例如硅酮,皮下输液套管能在穿刺元件320停留在流动限流器380的外径与皮下套管360的内径之间的同时,在其周围形成流体密封,接着当取出穿刺元件320时,皮下套管360在流动限流器380的周围形成流体密封,从而继续使用。
穿刺元件320包括穿刺器套321,允许病人在将套管360放入病人皮下组织后,从流体给药装置300中取出穿刺元件320。穿刺元件320还包括穿刺器套管322和尖锐的末端尖端323,以帮助穿刺病人的皮肤而进入皮下组织。穿刺器套管322可以由刚性的或半刚性的金属如不锈钢或上述的其它材料制成。
图30和31表示流体给药装置穿刺病人900的皮肤200,并牢固地附着在皮肤上。图30的流体给药装置与图29的装置相似,但在注射器套340中包括针头隔膜342,而不是Luer接头和止回阀。
图30表示流体给药装置300的穿刺元件320位于合适的位置上,将要穿刺皮肤210的表面并进入皮下组织211。如图所示,装置处于相对垂直于病人皮肤210的表面。优选的方法是将穿刺器尖323快速刺入病人皮肤210的表面,由此使皮下套管360的末端部分尽可能直到片套管连接区312起始处,与穿刺器套管322的末端部分一起刺入病人900,如图31所示。
当皮下套管360刺入病人后,从装置300中取出穿刺元件320。接着,折叠流体给药装置300露出病人900的部分,使皮肤片310的粘结剂一侧接触病人皮肤210的表面,并将装置300牢固粘贴到病人900上,使注射器套340露出用于接收针头,并使皮下套管360的末端尖端固定于病人900的皮下组织211中合适的位置,如图32和33所示。
图34和35表示与图30和31的装置相似的另一个装置300,但其还包括蓄液器约束351,用于将可膨胀的蓄液器350的总膨胀限制到由蓄液器约束351限定的一个固定体积。增加蓄液器约束351使使用者,例如病人或医生,通过在填充时应用标称大小的力,易于在每次使用时以相同的体积填充流体给药装置300,或者简单地使用最大剂量和较小体积的剂量。图35表示容纳针头910的装置300的注射器隔膜342。
尽管图示和描述了本发明的代表性实施例,但本领域一般技术人员在不必偏离本发明精神和范围的情况下可以做出修改和替代。例如,图示的一些所述装置具有或不具有可收缩的或可移动的经皮穿刺元件。其它的装置包括用于进入装置的针头可穿刺的进入口或诸如Luer的机械阀。图示的一些装置具有预先充满的药物贮存器,以及可以由保健提供者、病人或其它使用者充满的贮存器。所有这些特殊的实施例,以及上面所述的其它实施例,包括但不限于如下结构和材料:贮存器结构、适应性部分和其结构、流动限制元件和结构、流体通道上添加止回阀,在不偏离所述本发明精神和范围的情况下,它们可以应用在上述各种装置中。
另外,虽然本专利申请以特定的顺序列出方法或过程的步骤,但可能或者在某些情况下甚至可以改变一些步骤执行的顺序,并且在下面权利要求中提出的方法或过程的特殊步骤并不认为是特定的顺序,除非权利要求中明确地描述了这种顺序的特殊性。

Claims (34)

1.一种将流体输送到病人的装置,包括:
确定出一贮存器的外壳;
入口阀,从外壳的外部可以进入并且与贮存器连接;
皮下输液套管,其从外壳中伸出,与贮存器流体相通并包括一末端尖端;以及
皮肤穿刺元件,其位于输液套管内,并可在收缩位置和扩张位置之间移动,处于收缩位置时穿刺元件的尖锐尖端包含在装置内,处于扩张位置时穿刺元件的尖锐尖端从套管的末端尖端伸出。
2.如权利要求1所述的装置,还包括输液套管附近的外壳外表面上的粘结剂层。
3.如权利要求1所述的装置,其特征在于:所述皮下输液套管是柔性的。
4.如权利要求1所述的装置,其特征在于:所述皮下输液套管包括至少两个内腔。
5.如权利要求1所述的装置,其特征在于:所述入口阀包括针头隔膜。
6.如权利要求1所述的装置,其特征在于:所述入口阀包括Luer接头。
7.如权利要求1所述的装置,其特征在于:所述入口阀包括单向阀。
8.如权利要求1所述的装置,其特征在于:所述皮肤穿刺元件的外尺寸大于所述皮下输液套管的内尺寸。
9.如权利要求1所述的装置,其特征在于:所述穿刺元件是针头。
10.如权利要求1所述的装置,其特征在于:所述穿刺元件是中空的。
11.如权利要求1所述的装置,其特征在于:所述穿刺元件是实体的。
12.如权利要求1所述的装置,其特征在于:所述穿刺元件是柔性的。
13.如权利要求1所述的装置,其特征在于:所述穿刺元件是直的。
14.如权利要求1所述的装置,其特征在于:所述穿刺元件是弯曲的。
15.如权利要求1所述的装置,其特征在于:所述穿刺元件的长度大于所述外壳的横向尺寸。
16.如权利要求1所述的装置,其特征在于:所述穿刺元件移动路线的长度大于所述外壳的横向尺寸。
17.如权利要求1所述的装置,其特征在于:所述皮肤穿刺元件穿过外壳上的一个开口而进入所述输液套管。
18.如权利要求1所述的装置,还包括穿过外壳延伸并连接到所述穿刺元件上的一个可移动收缩器。
19.如权利要求18所述的装置,其特征在于:所述收缩器可分离地连接在所述穿刺元件上。
20.如权利要求18所述的装置,其特征在于:所述收缩器穿过所述入口阀。
21.如权利要求18所述的装置,其特征在于:所述收缩器穿过所述外壳上的一个开口。
22.如权利要求1所述的装置,还包括套管中的流动限制元件。
23.如权利要求22所述的装置,还包括可膨胀的蓄液器,它与所述贮存器和所述流动限制器之间流体相通。
24.如权利要求23所述的装置,其特征在于:所述蓄液器包括所述套管的一适应性部分。
25.如权利要求23所述的装置,其特征在于:所述蓄液器包括将其限制在一预定最大体积的约束。
26.如权利要求22所述的装置,其特征在于:所述穿刺元件穿过所述流动限制元件。
27.如权利要求26所述的装置,其特征在于:所述流动限制元件弹性地膨胀,用于接收所述穿刺元件。
28.如权利要求1所述的装置,其特征在于:所述贮存器包括第一和第二部分,所述第一部分连接所述输液套管,所述第二贮存器是可膨胀的并连接到所述入口阀,并且所述部分的布置使得所述第二部分的膨胀可增大所述第一部分内的压力。
29.如权利要求28所述的装置,其特征在于:所述贮存器的第一和第二部分由可移动的活塞隔开。
30.如权利要求28所述的装置,其特征在于:所述贮存器的第一和第二部分是由柔性膜形成的。
31.如权利要求28所述的装置,其特征在于:所述贮存器的第一部分具有固定的容积。
32.如权利要求28所述的装置,其特征在于:所述贮存器的第一部分的容积被所述装置的外壳限制。
33.如权利要求28所述的装置,其特征在于:所述贮存器的第一部分预先充满药物。
34.如权利要求28所述的装置,其特征在于:所述贮存器的第一部分包括一填充口。
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CN103857427A (zh) * 2011-07-25 2014-06-11 普雷斯弗雷克斯股份公司 流体分配器
CN103857427B (zh) * 2011-07-25 2018-01-30 普雷斯弗雷克斯股份公司 流体分配器
CN105492037A (zh) * 2013-05-30 2016-04-13 韦贝尔Cds公司 给送流体至患者的装置
CN111770768A (zh) * 2018-01-02 2020-10-13 贝克顿·迪金森公司 用于药物输送装置的端口接口
WO2022052574A1 (en) * 2020-09-08 2022-03-17 Medtrum Technologies Inc. Needle mechanism module for drug infusion device

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ES2281457T3 (es) 2007-10-01
CN100366305C (zh) 2008-02-06
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ATE352333T1 (de) 2007-02-15
CA2427567A1 (en) 2002-05-23
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US6699218B2 (en) 2004-03-02

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