CN106573115A - 具有扣合特征的附属装置 - Google Patents

具有扣合特征的附属装置 Download PDF

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CN106573115A
CN106573115A CN201580045675.0A CN201580045675A CN106573115A CN 106573115 A CN106573115 A CN 106573115A CN 201580045675 A CN201580045675 A CN 201580045675A CN 106573115 A CN106573115 A CN 106573115A
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delivery
recording equipment
medicine
hole
component
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CN106573115B (zh
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I.麦克劳格林
N.E.贾科布森
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Novo Nordisk AS
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Novo Nordisk AS
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Priority to EP14182145.4 priority
Priority to EP14191476.2 priority
Priority to EP14191476 priority
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Priority to PCT/EP2015/069396 priority patent/WO2016030348A1/en
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    • 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
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566Means improving security or handling thereof
    • A61M5/31568Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • 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
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6036General characteristics of the apparatus with identification means characterised by physical shape, e.g. array of activating switches
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6045General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes

Abstract

一种记录装置,其适于附接到笔式药物输送装置(210)并捕获关于在排出事件期间从药物输送装置排出的药物的剂量给送量的性质值,所述记录装置包括孔,其中,带有柔性丝线部分的扣锁周向地布置在所述孔中,所述丝线适于在笔装置被轴向地插入孔中时由笔装置上的突起使其侧向地运动且随后向内扣合。以这种方式,在记录装置与药物输送装置之间提供轴向扣锁。

Description

具有扣合特征的附属装置
技术领域
[0001] 本发明总体上涉及医疗装置,数据的生成、收集和储存与之相关。在具体实施例中,本发明涉及用于以有效的和用户友好的方式捕获并组织药物输送剂量数据的装置和系统。
背景技术
[0002] 在本发明的公开内容中,主要参考包括由旋转的驱动构件驱动的螺纹活塞杆的药物输送装置,此类装置例如用在通过输送胰岛素对糖尿病的治疗中,然而,这仅仅是本发明的示例性用途。
[0003] 药物注射装置已极大地改善了必须自己施用药物和生物制剂的患者的寿命。药物注射装置可采取许多种形式,包括简单的一次性装置(仅是带有注射器件的安瓿而已),或其可以是适合于与预填充药筒一起使用的耐用装置。不论其形式和类型如何,其均已被证明极大地有助于辅助患者自己施用可注射药物和生物制剂。其也极大地辅助护理者为无能力执行自身注射的患者施用可注射药品。
[0004] 在正确的时间且以正确的大小执行必要的胰岛素注射对于应对糖尿病而言是至关重要的(即,遵从指定的胰岛素治疗计划是重要的)。为了使医务人员有可能确定所开具的剂量给送模式的有效性,鼓励糖尿病患者保持记录每次注射的大小和时间。然而,此类记录通常保存在手写的笔记本中,会不容易从所记录的信息上传到计算机以便数据处理。此夕卜,由于仅由患者写下的事件被记录,因此如果所记录的信息将对治疗患者的疾病有任何价值,那么笔记本系统要求患者记得记录每次注射。记录中的缺失或错误记载导致注射历史的误导的状况,并且因此导致医务人员关于未来用药作出的决策的误导基础。因此,可以期望使来自药物输送系统的射出信息的记录自动化。
[0005] 尽管一些注射装置将该监测/获取机构整合在装置本身中(例如,如US 2009/0318865和WO 2010/052275中所公开的),但现今的多数装置是没有该监测/获取机构的。使用最广泛的装置是纯粹的机械装置,其或者是耐用型或者是预填充型。后一种装置将在排空后被丢弃,且如此廉价以至于在装置本身中内置电子数据获取功能不是成本有效的。为解决这个问题,已提出了许多种解决方案,这些解决方案将帮助用户生成、收集和分发指示给定医疗装置的使用的数据。
[0006] 例如,WO 2007/107564描述了电子“附加”模块,所述模块适于附接到机械笔装置并测量由所述机械笔装置生成的信号。检测到的信号可被用于检测不同事件,例如不同声音分别指示设定剂量和射出剂量。存储器储存检测到的剂量连同时间戳(例如,在若干个月内)。该模块设有无线器件,所述无线器件用于将检测到的数据传送到外部单元(例如,计算机或另一个便携式装置(例如,手机、PDA))以便进一步处理和可视化。
[0007] WO 2010/037828公开了用于将这种模块安装在笔形药物输送装置上的布置,所述模块包括一对柔性腿部,从而允许将所述模块夹持于药物输送装置上。US 6,482, 185和WO03/005891中示出笔装置的另外的外部装置。
[0008] 考虑到上述内容,本发明的目标是提供允许安全、简单和成本有效地操作包括用户可安装模块的药物输送组件的装置和方法。
发明内容
[0009] 在本发明的公开内容中,将描述多个实施例和方面,这些实施例和方面将实现上述目标中的一个或多个,或将实现从以下公开内容以及从示例性实施例的描述中显而易见的目标。
[0010]因此,在本发明的第一个一般方面中,提供一种适于可释放地附接到药物输送装置的记录装置,所述药物输送装置包括药物贮存器或用于接收药物贮存器的器件;药物排出器件,其包括允许用户设定待排出的药物的剂量给送量的剂量设定器件;以及大体上圆筒形的联接部分,其具有至少一个侧向突起,所述记录装置包括适于产生药物的排出剂量给送量的记录的电子电路。所述电子电路包括传感器器件,所述传感器器件适于在记录装置被附接到药物输送装置时捕获关于在排出事件期间由排出器件从贮存器排出的药物的剂量给送量的性质值。记录装置进一步包括适于接收联接部分的大体圆筒形的孔。记录装置包括适于接合药物输送装置上的侧向突起的至少一个单独的扣锁,所述单独的扣锁包括柔性丝线部分,所述柔性丝线部分周向地布置在孔中且适于在联接部分被轴向地插入孔中时由侧向突起使其侧向地运动并随后向内扣合,由此在记录装置与药物输送装置之间提供轴向扣锁。
[0011] 通过该布置,使用一个或多个单独的丝线,能够优化扣紧力(snap-on force),以实现牢固附接和使用容易性两者,正如能够选择丝线材料以便在附加装置的寿命内保持其强度,由此提供坚固的固定那样。
[0012]