Container for storing a drug such as insulin
Inventors
Bianchi, François • Lettieri, Gian-Luca • Proennecke, Stephan
Assignees
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Publication Number
US-12083070-B2
Publication Date
2024-09-10
Expiration Date
Abstract
A polymeric container for storing a drug such as insulin which comprises a hard shell (2) and a flexible film (1), wherein both elements are made from the same material.
Core Innovation
The invention relates to a device for storage of a drug that includes a hard shell made of a first material and a flexible film bonded to the hard shell, thereby defining a liquid-tight container between the flexible film and the hard shell. The flexible film includes a blend of the first material and a second material, where the second material is an elastomeric formulation of the first material such that the hard shell and the flexible film comprise the same first material.
The liquid-tight container is configured to be filled with a liquid pharmaceutical solution. The flexible film is configured to expand upon filling with the liquid pharmaceutical solution and to collapse upon depletion, and to reach a pre-formed shape in which an inner surface of the flexible film closely fits an inner surface of the hard shell upon emptying of the liquid-tight container.
The collapse of the flexible film is defined as not caused by an external force that is applied to the flexible film. In related embodiments, the device additionally includes an outlet port connected to a fluid delivery device with a filter disposed inside the liquid-tight container to cover the outlet port and prevent entrapment of air bubbles downstream of the outlet port.
Claims Coverage
The excerpt provides three independent claims. The core coverage centers on a hard shell bonded to a flexible, elastomer-modified first-material film that expands when filled, collapses upon depletion into a pre-formed closely fitting shape, with collapse not caused by external force; additional coverage includes an internal filter at an outlet port and a medical device configuration combining the storage device with a pump.
Hard shell and bonded flexible film forming a liquid-tight container
A hard shell made of a first material and a flexible film bonded to the hard shell defining a liquid-tight container, wherein the flexible film comprises a blend of the first material and a second material, the second material being an elastomeric formulation of the first material such that the hard shell and the flexible film comprise the same first material.
Expansion on filling and collapse on depletion into a pre-formed closely fitting shape
The liquid-tight container is configured to be filled with a liquid pharmaceutical solution; the flexible film is configured to expand upon filling and to collapse upon depletion; the flexible film is configured to reach a pre-formed shape in which an inner surface of the flexible film closely fits an inner surface of the hard shell upon emptying.
Collapse not caused by external force applied to the flexible film
The collapsing of the flexible film by virtue of the pre-formed shape is not caused by an external force that is applied to the flexible film.
Outlet port with internal filter to prevent air-bubble entrapment downstream
An outlet port connected to a fluid delivery device, and a filter disposed inside the liquid-tight container on an inner surface of the hard shell to cover the outlet port and configured to prevent entrapment of air bubbles downstream of the outlet port.
Medical device including the drug storage device
A medical device comprising a drug storage device with a hard shell, a flexible film bonded to the hard shell, and the liquid-tight container configured as described, including the non-external-force collapse feature.
The independent claims require a drug-storage device with a hard shell and bonded flexible film using the same first material, where the flexible film expands with filling, collapses on depletion into a pre-formed closely fitting shape against the hard shell, and collapse is not caused by external force applied to the flexible film. The excerpt also includes coverage for an internal filter at an outlet port and a medical device configuration including the storage device.
Stated Advantages
Minimizing dead volume and air bubbles by configuring the flexible film to collapse into a pre-formed shape that closely fits the hard shell upon emptying.
Preventing entrapment of air bubbles downstream of the outlet port via a filter disposed inside the liquid-tight container.
Documented Applications
Use of the drug storage device in medical delivery by combining the storage device with a pump to infuse a patient.
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