Systems and methods for pre-filled medical delivery assemblies
A pre-filled medical delivery assembly assembled and 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 generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
1 . A pre-filled medical delivery assembly, comprising:
a blow-fill-seal (BFS) bottle defining a collapsible fluid chamber, a neck portion, and an exterior flange formed on the neck portion;
a collar defining a first end and a second end, the first end defining a mounting socket comprising an interior seat into which the exterior flange is axially mated and the second end defining a hub socket comprising internal threads;
a needle hub comprising at least one external thread cooperatively mated with the internal threads of the collar to a first degree of advancement, the needle hub being coupled to a double-ended needle disposed through the needle hub; and
a cap covering an administration end of the needle and the cap comprising an interior key that is operable to drive the needle hub to advance the at least one external thread of the needle hub to a second degree of advancement with respect to the internal threads of the hub socket of the collar,
wherein advancement of the threads to the second degree of advancement causes a piercing end of the double-ended needle to pierce a seal of the collar and to pierce a seal of the BFS bottle.
2 . The pre-filled medical delivery assembly of claim 1 , further comprising a safety shield coupled to the BFS bottle.
3 . The pre-filled medical delivery assembly of claim 2 , wherein the safety shield comprises a shield base coupled to the BFS bottle and a hinge element joining the shield base to a shield element.
4 . The pre-filled medical delivery assembly of claim 1 , further comprising a safety shield coupled to the collar.
5 . The pre-filled medical delivery assembly of claim 1 , further comprising a safety shield comprising an annular shield base through which the BFS bottle neck portion is inserted.
6 . The pre-filled medical delivery assembly of claim 5 , wherein the shield base comprises one or more mounting features that axially couple to corresponding features of the collar.
7 . The pre-filled medical delivery assembly of claim 1 , wherein the interior seat comprises an interior channel rounded at a radius in the range of four to five millimeters (4-mm to 5-mm).
8 . The pre-filled medical delivery assembly of claim 1 , wherein the interior seat extends radially outward into an interior wall of the mounting socket by a protrusion amount and wherein a length of the interior seat is in the range of four and three tenths times (4.3×) and five and three tenths times (5.3×) the protrusion amount.
9 . A medical administration assembly, comprising:
a collar defining a first end and a second end, the first end defining a mounting socket comprising an interior seat operable to accept an exterior flange of a blow-fill-seal (BFS) bottle that is axially mated and the second end defining a hub socket comprising internal threads;
a needle hub comprising at least one external thread cooperatively mated with the internal threads of the collar to a first degree of advancement, the needle hub being coupled to a double-ended needle disposed through the needle hub; and
a cap covering an administration end of the needle and the cap comprising an interior key that is operable to drive the needle hub to advance the at least one external thread of the needle hub to a second degree of advancement with respect to the internal threads of the hub socket of the collar,
wherein advancement of the threads to the second degree of advancement causes a piercing end of the double-ended needle to pierce a seal of the collar.
10 . The medical administration assembly of claim 9 , wherein advancement of the threads to the second degree of advancement further causes the piercing end of the double-ended needle to pierce a seal of the BFS bottle.
11 . The medical administration assembly of claim 9 , further comprising a seal covering an opening of the mounting socket.