Syringe for retaining and mixing first and second substances

Inventors

Larsen, Kristian

Assignees

Ferrosan Medical Devices AS

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Publication Number

US-10653837-B2

Patent

Publication Date

2020-05-19

Expiration Date


Abstract

The present disclosure relates to a syringe for retaining and/or mixing two substances which have been retained separately inside the syringe. In particular the present disclosure relates to a syringe for 1) retaining a dry composition in a vacuum, and 2) mixing the dry composition with an aqueous medium to form a flowable substance. One embodiment relates to a syringe for mixing first and second substances comprising a barrel comprising a vacuum chamber for holding a first substance, a plunger incorporating a reservoir chamber for holding a second substance and configured to be axially displaced in the vacuum chamber, and a valve for controlling and/or establishing a fluid connection between the vacuum chamber and the reservoir chamber.

Core Innovation

The invention describes a self-mixing syringe that stores a first substance under vacuum in a barrel vacuum chamber and stores a second substance in a reservoir chamber incorporated in a hollow axially slidable plunger. A valve separates the vacuum chamber in the barrel and the reservoir chamber inside the plunger, and the valve is configured to control and/or establish a fluid connection between the vacuum chamber and the reservoir chamber. The syringe includes a sealable and/or closable distal outlet to retain vacuum.

In a first configuration corresponding to a first locked axial position of the plunger inside the barrel, the first substance is retained under vacuum in the vacuum chamber such that the first configuration is a storage condition of the syringe. In a second configuration, when the plunger is unlocked, the vacuum in the vacuum chamber draws the plunger in a distal axial direction such that the valve is engaged to provide a fluid passageway between the reservoir chamber and the vacuum chamber, thereby enabling mixing of the first and second substances without external manual force.

The described syringe further supports vacuum-based preparation and storage behaviors, including vacuum bypass channels allowing freeze-drying/lyophilisation while vacuum is established, and then sealing for storage. The disclosed use includes vacuum-expanded freeze-dried pastes that reconstitute spontaneously with aqueous media, with example substances including thrombin-containing vacuum-expanded freeze-dried paste that reconstitutes in aqueous media.

Claims Coverage

The independent claim covers one inventive concept: a syringe that retains a first substance under vacuum in a barrel vacuum chamber during a locked storage condition and, upon unlocking and distal axial movement of a plunger, engages a valve to establish a fluid passageway between the vacuum chamber and a reservoir chamber holding a second substance. Dependent claims add specific valve behaviors and structural details of a plug and vacuum bypass channels.

Vacuum-stored first substance with sealable distal outlet and barrel vacuum chamber

A barrel comprising a sealable and/or closable distal outlet and a vacuum chamber for holding a first substance under vacuum.

Axially displaceable hollow plunger with integrated reservoir chamber for second substance

A plunger for sealable engagement inside the barrel and configured to be axially displaced in relation to the vacuum chamber, the plunger incorporating a reservoir chamber for holding a second substance.

Valve separating vacuum chamber and reservoir chamber to control fluid connection

A valve separating the vacuum chamber inside the barrel and the reservoir chamber inside the plunger, the valve configured for controlling and/or establishing a fluid connection between the vacuum chamber and the reservoir chamber.

Locked storage condition with first configuration retaining first substance under vacuum

The syringe configured such that, in a first configuration corresponding to a first locked axial position of the plunger inside the barrel, the first substance is retained under vacuum in the vacuum chamber such that said first configuration is a storage condition of the syringe.

Unlocked second configuration where vacuum draws plunger to engage valve and create fluid passageway

The syringe configured such that, in a second configuration the plunger is unlocked and the vacuum in the vacuum chamber draws the plunger in a distal axial direction such that the valve is engaged to provide a fluid passageway between the reservoir chamber and the vacuum chamber.

The core coverage centers on the combination of a barrel vacuum chamber and a locked storage plunger position that retains a first substance under vacuum, together with valve-controlled fluid passageway establishment between the vacuum chamber and a plunger reservoir chamber when the plunger is unlocked and drawn distally by vacuum.

Stated Advantages

Reduced mixing time.

Improved sterility/consistency.

Patient safety.

Suitability for drug lyophilizates and infusion reconstitution.

Documented Applications

Use of vacuum-expanded freeze-dried pastes that reconstitute spontaneously with aqueous media, including an example of thrombin-containing vacuum-expanded freeze-dried paste reconstituting with aqueous media.

Infusion reconstitution for drug lyophilizates.

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