System, apparatuses, devices, and methods for packaging an analyte diffusive implantable device
Embodiments of the present disclosure are directed to a biomedical packaging system which may include an assembly/primary packaging having one chamber configured to hold liquid nutrient media, as well as a bio-artificial organ (BAO), and another chamber arranged adjacent to the first compartment configured to be substantially liquid-free. The system can further include a baffle including a port, configured to separate the first chamber from the second chamber, as well as a storage container/secondary packaging.
1 . A biomedical packaging system comprising an assembly comprising:
a single, integral, circumferential side wall;
a first chamber configured to hold liquid nutrient media and a bio-artificial organ (BAO) and including a first side wall that comprises a first portion of the single, integral circumferential side wall;
a second chamber arranged adjacent to the first compartment and configured to be substantially liquid-free and including a second side wall that comprises a second portion of the single, integral circumferential side wall;
and
a baffle including a port, the baffle being configured to separate and seal off the first chamber from second chamber when the port is closed, such that material from the first chamber cannot flow or otherwise transfer into the second chamber.
2 . The system of claim 1 ,
wherein the second chamber includes a flange;
the single, integral circumferential wall includes a step between the first portion and the second portion thereof which is configured to retain or otherwise hold a perimeter of the baffle.
3 . The system of claim 2 , wherein a pitch of the baffle is between approximately 5 and 30 degrees.
4 . The system of claim 1 , wherein the baffle is configured to vent gas during the filling of the first chamber with liquid.
5 . The system of claim 1 , wherein the baffle is sealed to at least one of the first and second chambers.
6 . The system of claim 2 , wherein the system further comprises a closure system which comprises a plug.
7 . The system of claim 2 , further comprising a closure system which comprises a plug and a corresponding receptacle.
8 . The system of claim 7 , wherein the plug and the receptacle are configured or further configured to frictionally fit together.
9 . The system of claim 2 , further comprising a closure system further comprises a seal.
10 . The system of claim 7 , wherein:
at least one of the plug and the receptacle includes a mating portion for receiving at least one of a medical device or a BAO; and/or
the port of the baffle includes a neck portion configured to receive at least one of the plug and the receptacle.
11 . The system of claim 10 , wherein the at least one of the plug and the receptacle and the neck portion include corresponding mating means configured to connect the at least one of the plug and the receptacle with the neck portion.
12 . The system of claim 1 , further comprising a storage container.
13 . The system of claim 12 , wherein at least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage container are manufactured of a material having at least one of the following characteristics: transparency, medical grade, durable, non-degradable and substantially free from excipient release over time during exposure to elevated temperatures, pH and/or humidity.
14 . The system of claim 1 , wherein:
the second chamber includes a flange, and
at least one of the perimeter of the baffle and an inner circumference of a step portion of the single, integral, circumferential wall includes a material configured to seal the perimeter of the baffle with the step portion.
15 . The system of claim 1 , wherein:
the second chamber is sealed with a non-permeable membrane on or over a flange; the port is centrally arranged on the baffle;
the port is closed via at least one closure system; and/or
the baffle is configured with a pitch, and the pitch is configured from an edge of the baffle to the center of the baffle.