Packaging for hydrated articles and related methods
Packaging for hydrated articles are generally provided. In some embodiments, packaged articles are provided. For example, in some embodiments, a container contains an article such as a catheter and/or polymeric material. The disclosed packaged articles may be useful for, for example, providing controlled humidity conditions for contained components, maintaining consistent hydration levels of the packaged articles, and/or improved sterilization conditions. Advantageously, the packaged articles described herein may, in some embodiments, create an environment with minimum relative humidity for long-term storage of a catheter or polymeric material, increase shelf life of the catheter or polymeric material, and/or facilitate hydration of a catheter such that e.g., the catheter hydrates to intended dimensions within a specified amount of time. Methods for preparing such packaged article are also provided.
1 . A packaged article, comprising:
a container comprising a foil material;
a catheter comprising a polymeric material, the polymeric material having a water content of greater than or equal to 2 w/w % and less than or equal to 40 w/w %; and
a humidity control component comprising a humidity control sponge;
wherein the water content is less than an equilibrium water content of the polymeric material; and
wherein the polymeric material is configured to swell in an amount greater than or equal to 5 w/w % to an equilibrium water content state.
2 . A packaged article as in claim 1 , wherein the foil material is substantially impermeable to water.
3 . A packaged particle as in as in claim 1 , wherein the container is a pouch.
4 . A packaged article as in claim 1 , wherein the container further comprises a vapor permeable polymer.
5 . A packaged article as in claim 1 , wherein the polymeric material comprises poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinyl pyrrolidone), poly(methacrylic sulfobetaine), poly(acrylic sulfobetaine), poly(methacrylic carboxybetaine), poly(acrylic carboxybetaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazolines, polyphosphates, polyphosphazenes, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethylmethacrylate), and combinations thereof.
6 . The packaged article of claim 1 , wherein the polymeric material is configured to swell to the equilibrium water content state in a time period of less than or equal to 60 minutes at 25° C.
7 . The packaged article of claim 1 , wherein the catheter has an inner diameter, an outer diameter, and a length; and wherein the polymeric material is configured to swell such that the inner diameter and/or outer diameter increase by a larger percentage than percentage increase in length.
8 . The packaged article of claim 1 , further comprising a biologically active agent present in the catheter in an amount of greater than or equal to 0.01 w/w % versus a total weight of the catheter.
9 . The packaged article of claim 1 , wherein the polymeric material has a water content of less than 5 w/w % and greater than or equal to 0.1 w/w % in a dehydrated state, and wherein the polymeric material is configured to swell in an amount greater than or equal to 5 w/w % and less than or equal to 50 w/w % from the dehydrated state to the equilibrium water content state in less than or equal to 60 minutes.
10 . The packaged article of claim 1 , wherein the polymeric material has a Young's elastic modulus of greater than or equal to 500 MPa in a dehydrated state and a Young's elastic modulus of less than or equal to 300 MPa and greater than or equal to 5 MPa at an equilibrium water content state.
11 . The packaged article of claim 1 , wherein the catheter has a coefficient of friction of less than or equal to 0.10 at the equilibrium water content state.
12 . The packaged article of claim 1 , wherein the catheter comprises an osmotic agent present in the polymeric material in an amount greater than or equal to 0.05 w/w % and less than or equal to 2 w/w % versus a total catheter weight.
13 . The packaged article of claim 1 , wherein the polymeric material is substantially non-thrombogenic.
14 . The packaged article of claim 1 , wherein the humidity control component further comprises an antiseptic or anti-infective agent.
15 . The packaged article of claim 1 , wherein the humidity control component is configured to be removed from the container.
16 . The packaged article claim 1 , wherein the packaged article comprises a humectant.
17 . The packaged article of claim 16 , wherein the humectant comprises poloxamer, polyethylene glycol, glycerol, propylene glycol, ethylene glycol, butylene glycol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, malitol, lactitol, maltotriitol, maltotetraitol, and/or polyglycitols.
18 . The packaged article of claim 1 , wherein the catheter has a plurality of pores.
19 . The packaged article of claim 18 , wherein the polymeric material comprises a first water soluble polymer and wherein the catheter further comprises a second water soluble polymer that is the same or different than the first water soluble polymer and positioned within at least a portion of the plurality of pores.
20 . The packaged article of claim 19 , wherein the first water soluble polymer does not comprise covalent crosslinking agents.
21 . The packaged article of claim 1 , further comprising hydration media.
22 . The packaged article of claim 21 , wherein the hydration media comprises water, lactated Ringer's solution (LRS), dextrose (D5W), phosphate buffered saline (PBS), and/or Hanks' Balanced Salt Solution (HBSS).
23 . A packaged article, comprising:
a container comprising a foil material;
a polymeric material comprising poly(vinyl) alcohol, the polymeric material having a water content of greater than or equal to 2 w/w % and less than or equal to 40 w/w %; and
a humidity control component comprising a humidity control sponge;
wherein the water content is less than an equilibrium water content of the polymeric material; and
wherein the polymeric material is configured to swell in an amount greater than or equal to 5 w/w % to an equilibrium water content state.
24 . The packaged article of claim 23 , wherein the humidity control component further comprises an antiseptic or anti-infective agent.
25 . A packaged article as in as in claim 1 , comprising a header portion.
26 . A method, comprising:
removing, from the packaged article of claim 1 , the catheter; and
rehydrating the catheter to equilibrium water content.