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A method for an aseptic assembly of a multi-component medical device and a kit therefor

A medical device, multi-component technology, applied in the field of multi-component medical devices, can solve the problems of inactivation, difficulty, sensitive unit shielding, etc., and achieve the effect of cost reduction and sterilization volume reduction

Active Publication Date: 2018-08-03
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method of sterilization runs into trouble when electronic units such as signal amplifiers and adhesive coatings are damaged by ionizing radiation
[0003] The applicant has observed that it is difficult to shield sensitive cells from ionizing radiation
On the downside, radiation shielding is also a necessary quality of shielding material, which increases manufacturing cost and packaging volume
On the other hand, additional components, such as enzyme-containing sensor elements, may be inactivated by reactive germicidal gases
The problem with this is that the commonly used ethylene oxide gas is dissolved in common packaging materials, thus requiring overpackaging of the gas sensing system components

Method used

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  • A method for an aseptic assembly of a multi-component medical device and a kit therefor
  • A method for an aseptic assembly of a multi-component medical device and a kit therefor
  • A method for an aseptic assembly of a multi-component medical device and a kit therefor

Examples

Experimental program
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Embodiment Construction

[0032] figure 1 Shown is a first container 10 comprising a first component 12 of a multi-component medical device. In this embodiment, the first component 12 comprises an applicator unit 13 combined with a patch 14 comprising an electronic component 16 and an adhesive pad 18 . The first container 10 has a rigid wall 20 , a transparent flexible wall 22 , a gas permeable membrane 24 and a cover 26 provided with a first rupturable portion 28 and coated with an adhesive layer 30 covered by a liner 32 .

[0033] as from figure 2 As evident in the figure, the first rupturable portion 28 is preferably formed from aluminum foil as a circular insert and reinforced by a central fin 34 which provides the cover 26 with a bendable connecting link 4 . Advantageously, the cover 26 is configured with a transverse cutout 36 as a positioning aid, as will be explained further below.

[0034] exist figure 1 In the state shown in , the first component 12 can be sterilized using gas sterilizat...

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Abstract

The invention concerns a method for an aseptic assembly of a multi- component medical device (60) comprising the steps of: providing a first component (12) of the medical device (60) in a first container (10) and a second component (40) of the medical device (60) in a second container (38), wherein each of the separated containers (10,38) comprises a ruptureable portion (28,52),sterilizing the first component (12) in the first container (10) using a first sterilization technique and sterilizing the second component (40) in the second container (38) using a second sterilization technique, joining the first and second container (10,38) while arranging the ruptureable portions (28,52) in an overlapping configuration which is aseptically sealed against the surroundings, transferring one of thecomponents through the ruptureable portions (28,52) and aseptically assembling the components to form the medical device (60) as a sterile package.

Description

technical field [0001] The present invention relates to a method for the aseptic assembly of multi-component medical devices, in particular skin-mountable sensor devices, such as systems for continuous glucose monitoring. The invention also relates to a sterile kit for providing such a multi-component medical device. Background technique [0002] US Patent 2014 / 20348703 A1 states that it is important for a device to be implanted in the body or located below the user's skin surface to be sterile at the time of insertion. In this context, said document discloses methods and systems for the sterilization of medical devices including devices for continuous or automatic monitoring of analytes, such as glucose, in body fluids. There is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a container optionally including a substantially hermetically sealed container, and irradiating the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M5/00A61M5/14A61L2/20A61L2/08A61L2/04
CPCA61M5/001A61M5/1413A61L2/04A61L2/087A61L2/206A61L2202/181A61L2202/24A61M5/00A61B5/14532A61B2562/242A61L2202/23B65B55/02
Inventor H.哈蒂希
Owner F HOFFMANN LA ROCHE & CO AG
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