Systems and methods for blow-fill-seal (bfs) tear-activation valves
AssigneeKoska Family Limited
InventorsMarc Andrew Koska, Jeff Price, Max Kingsley Hannon
Life of this patent
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Abstract
A pre-filled medical delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly including a tear-activation valve that provides for an internal, mechanical BFS vial opening, and defines an Auto-Disable (AD) feature that prevents refilling or re-use of the assembly.
Claims16
A pre-filled, Auto-Disable (AD) medical delivery device, comprising:a Blow-Fill-Seal (BFS) vial comprising:(i) an exterior radial flange;(ii) a collapsible fluid chamber;(iii) a fluid seal at a distal end of the BFS vial;
- and(iv) a tear-activation valve disposed at the fluid seal, the tear-activation valve comprising an axial projection;an administration assembly comprising:(i) an interior volume comprising an interior seat and at least one flange guide;(ii) an opening at a first end, the opening being in communication with the interior volume;(iii) a fluid channel extending between the interior seat and a second end;(iv) a needle disposed at the second end and in communication with the fluid channel;
- and(v) a shear projection disposed within the interior seat;
- andwherein the at least one flange guide is cooperatively configured to accept and guide the exterior radial flange of the BFS vial,wherein the interior seat is cooperatively configured to accept the tear-activation valve, andwherein the shear projection is configured to engage the tear-activation valve at a particular degree of rotation and cause the tear-activation valve to form a hole in the fluid seal, exposing fluid contents of the collapsible fluid chamber to the fluid channel.
A pre-filled, Auto-Disable (AD) Blow-Fill-Seal (BFS) vial, comprising:a body defining a collapsible fluid chamber pre-filled with a medical fluid;a neck portion extending axially from the body, the neck portion defining an outer radial surface and defining an interior volume in fluid communication with the collapsible fluid chamber;an angled exterior radial flange extending radially outward from the neck portion and being angled with respect to a plane normal to an axis of the BFS vial;a tear-activation valve formed at a distal end of the neck, the tear-activation valve comprising a first shaped portion having a diameter less than a diameter of the neck portion;a fluid seal formed at a junction of the neck portion and the first shaped portion of the tear-activation valve;
- anda fluid channel feature formed on the outer radial surface of the neck portion and extending axially along a portion of the outer radial surface between the angled exterior radial flange and the fluid seal.
A pre-filled, Auto-Disable (AD) Blow-Fill-Seal (BFS) administration assembly comprising:a cylindrical body comprising a proximate end and a distal end, the cylindrical body defining an interior volume comprising an interior valve seat and at least one flange guide;an opening at the proximate end, the opening being in communication with the interior volume;a fluid channel extending between the interior valve seat and the distal end;a needle disposed at the distal end and in communication with the fluid channel;
- anda shear projection disposed within the interior seat, the shear projection defining at least one shear surface disposed normal to a surface of the interior valve seat, and the shear projection occupying a first portion of the interior valve seat with a second portion of the interior valve seat remaining unimpeded by the shear projection.
Dependencies are inferred from the claim text.