Packaging system for a medical product

Patent metadata

Field	Value
Publication number	US-2022142150-A1
Application number	US-202117504694-A
Country	US
Kind code	A1
Filing date	Oct 19, 2021
Priority date	Nov 10, 2020
Publication date	May 12, 2022
Grant date	—

Abstract

A packaging system includes a holder and an inner container. The holder includes a top portion and a bottom portion that cooperate to form a cavity configured to receive one or more medical products therein and to retain the one or more medical products therein. The inner container defines an interior region configured to receive the holder therein. The holder includes sidewalls that form the cavity, and the sidewalls include channels configured to fluidly connect the cavity to the interior region of the inner container.

First claim

What is claimed is:

1 . A packaging system, comprising:
a holder, including a top portion and a bottom portion that cooperate to form a cavity configured to receive one or more medical products therein and to retain the one or more medical products therein; and an inner container, wherein the inner container defines an interior region configured to receive the holder therein, wherein the holder includes sidewalls that form the cavity, and wherein the sidewalls include channels configured to fluidly connect the cavity to the interior region of the inner container.

2 . The packaging system of claim 1 , wherein the inner container includes an inner tray that includes a first portion and a second portion, wherein the first portion and the second portion each include an interlocking portion that forms a seal when coupled together.

3 . The packaging system of claim 1 , further comprising:
an outer container, wherein the outer container includes a well configured to receive the inner container therein.

4 . The packaging system of claim 1 , wherein the channels are formed by extensions and indentations in the sidewalls.

5 . The packaging system of claim 4 , wherein the extensions and indentations in the sidewalls are rounded.

6 . The packaging system of claim 1 , wherein at least one of the holder, the inner container, or the outer container is formed of a plastic material and/or via thermoforming.

7 . The packaging system of claim 1 , wherein the inner container is a vial.

8 . The packaging system of claim 7 , wherein the vial includes one or more retention features that project inward into the vial and are dimensioned to constrain movement of the holder when received within the vial.

9 . The packaging system of claim 7 , wherein the vial includes one or more surface features configured to inhibit rolling of the vial when placed on a surface.

10 . The packaging system of claim 1 , further comprising a fluid configured to preserve one or more medical products within the cavity of the holder.

11 . A method of packaging one or more medical products, the method comprising:
inserting a medical product within a cavity of a holder; closing the holder to enclose the medical product; inserting the holder and the medical product into one portion of an inner container; delivering a liquid into the one portion of the inner container; coupling another portion of the inner container to the one portion of the inner container to enclose the holder and the medical product within the inner container; inserting the inner container, the holder, and the medical product into an outer container; and covering a portion of the outer container with a sealing material.

12 . The method of claim 11 , wherein closing the holder includes coupling a coupling portion on a bottom portion of the holder to a coupling portion on a top portion of the holder to enclose the medical product within the cavity of the holder.

13 . The method of claim 11 , wherein covering the portion of the outer container with the sealing material includes forming a Tyvek seal over the outer container.

14 . The method of claim 11 , wherein the medical product includes one or more of a nerve tissue, a vein graft, a vascular tissue, an urological tissue, a tendon, or a muscle tissue.

15 . The method of claim 11 , wherein the liquid includes a solution including about 2% to about 15% by volume dimethyl sulfoxide (DMSO), and one or more monovalent and/or divalent metal cations.

16 . A method of storing one or more medical products, comprising:
packaging the one or more medical products according to the method of claim 11 ; and storing the one or more packaged medical products.

17 . The method of claim 16 , further comprising:
exposing the one or more packaged medical products to a temperature of approximately −85 degrees Celsius.

18 . The method of claim 17 , wherein storing the one or more packaged medical products includes exposing the one or more medical products to a temperature of about 15 degrees Celsius to about 30 degrees Celsius.

19 . A holder for one or more medical products, comprising:
a top portion; and a bottom portion pivotably connected to the top portion via a joint, wherein the top and bottom portions cooperate to form a cavity configured to hold one or more medical products therein, wherein the cavity is fluidly connected to an exterior of the holder, wherein one or both of the top portion or the bottom portion include sidewalls that form the cavity, and wherein the sidewalls include a plurality of channels to fluidly connect the cavity to the exterior of the holder, and wherein the channels through the sidewalls are formed by rounded extensions and indentations in the sidewalls.

20 . The holder of claim 19 , wherein the top portion and the bottom portion each include a coupling portion configured to secure the holder in a closed configuration when mated together, wherein the coupling portion of the top portion includes either a hole or a peg, and wherein the coupling portion of the bottom portion includes either the peg or the hole configured to mate with the peg or the hole of the top portion.

21 . The holder of claim 19 , wherein the top portion and the bottom portion are formed of plastic and shaped via thermoforming.

22 . A packaging system, comprising:
the holder of claim 19 ; and a vial.

23 . The packaging system of claim 22 , wherein the vial includes one or more retention features that project inward into the vial and are dimensioned to constrain movement of the holder when received within the vial.

24 . The packaging system of claim 23 , wherein the vial includes one or more surface features configured to inhibit rolling of the vial when placed on a surface.

25 . The packaging system of claim 22 , further comprising a fluid configured to preserve one or more medical products contained within the cavity of the holder.

26 . The packaging system of claim 22 , wherein the vial is at least partially transparent and is formed of one or more of polypropylene, high density polyethylene, polymethylpentene, polyethylene terephthalate glycol-modified, or fluorinated ethylene propylene.

27 . The packaging system of claim 26 , wherein the vial is configured to withstand temperatures ranging from about −85 degrees Celsius to about 50 degrees Celsius.

Assignees

• Axogen Corp

Inventors

• Romot Brian
• Deuerling Justin
• Slade Cristina
• Kabra Shashank
• Severin Jane

Classifications

• A01N1/122

  Preservation or perfusion media · CPC title

• A01N1/142 Primary

  Apparatus · CPC title

• A01N1/148 Primary

  with provisions specially adapted for transporting · CPC title

• A01N1/146 Primary

  Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving · CPC title

• A61F2220/0033

  made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit · CPC title