SYSTEMS AND METHODS FOR PRE-FILLED MEDICAL DELIVERY DEVICES
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 device, comprising:
a blow-fill-seal (BFS) vial defining a collapsible fluid chamber, a dispensing chamber in communication with the collapsible fluid chamber, a neck portion in communication with the dispensing chamber, and an exterior flange formed on the neck portion, wherein the exterior flange comprises an axially elongated and rounded protrusion having a flange length in the range of thirty to forty-five percent (30%-45%) of a length of the neck portion; and
an administration assembly defining an opening at one end, the opening being in communication with an interior volume comprising an interior seat into which the exterior flange is axially mated, and the administration member comprising, at a second end, a needle.
2 . The pre-filled medical delivery device of claim 1 , wherein the BFS vial further comprises:
a constriction between the fluid chamber and the dispensing chamber.
3 . The pre-filled medical delivery device of claim 2 , wherein the constriction comprises a diameter in the range of three to four millimeters (3-mm to 4-mm).
4 . The pre-filled medical delivery device of claim 1 , wherein the exterior flange is rounded at a radius in the range of four to five millimeters (4-mm to 5-mm).
5 . The pre-filled medical delivery device of claim 1 , wherein the exterior flange extends radially outward from the neck portion by a protrusion amount and wherein the flange length is in the range of four and three tenths times (4.3×) and five and three tenths times (5.3×) the protrusion amount.
6 . A blow-fill-seal (BFS) vial, comprising:
a collapsible fluid chamber;
a dispensing chamber in communication with the collapsible fluid chamber;
a cylindrical neck portion in communication with the dispensing chamber; and
an exterior flange formed on the neck portion, wherein the exterior flange extends radially outward from the neck portion by a protrusion amount and wherein an axial length of the exterior flange is in the range of four and three tenths times (4.3×) and five and three tenths times (5.3×) the protrusion amount.
7 . The BFS vial of claim 6 , wherein the axial length of the exterior flange is in the range of thirty to forty-five percent (30%-45%) of a length of the neck portion.
8 . The BFS vial of claim 6 , wherein the BFS vial further comprises:
a constriction between the fluid chamber and the dispensing chamber.
9 . The BFS vial of claim 8 , wherein the constriction comprises a diameter in the range of three to four millimeters (3-mm to 4-mm).
10 . The BFS vial of claim 6 , wherein the exterior flange is rounded at a radius in the range of four to five millimeters (4-mm to 5-mm).
11 . The BFS vial of claim 6 , wherein at least one of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck is filled, during manufacture, with a volume of liquid.
12 . The BFS vial of claim 11 , wherein at least one of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck also comprises a volume of gas.
13 . The BFS vial of claim 12 , wherein the volume of gas is in the range of one hundred to two hundred and fifty percent (100%-250%) of the volume of liquid.