Methods and Systems for Storing Medical Implants Under Sustained Vacuum
Methods and systems for improving the shelf life of a medical graft generally comprising a medical implant container having at least one graft cavity configured to hold at least one graft under a first vacuum and a needle entry port in fluid communication with the at least one graft cavity, the needle entry port being configured to receive and communicate a material to the at least one graft cavity and an outer chamber configured to hold the medical implant container under a second vacuum.
1 - 20 . (canceled)
21 . A kit for storing freeze-dried or dehydrated medical grafts under vacuum, comprising:
a hermetically sealed medical implant container comprising:
at least one graft cavity configured to store at least one graft under a first sustained vacuum;
top, side, and bottom walls defining an inner surface of the container;
a lip surrounding a periphery of the graft cavity with the top wall hermetically sealed to the lip adjacent the substrate cavity periphery; and
a needle entry port in fluid communication with the at least one graft cavity, the needle entry port being configured to receive and communicate a material to the at least one graft cavity; and
an outer chamber configured to store the medical implant container under a second sustained vacuum.
22 . The kit of claim 21 , wherein the first vacuum and second vacuum are between 1 and 30 inHg.
23 . The kit of claim 21 , wherein the first vacuum and second vacuum are substantially the same.
24 . The kit of claim 21 , wherein the first vacuum and second vacuum are not substantially the same.
25 . The kit of claim 21 , wherein the outer chamber is made of a material selected from the group consisting of silicon oxide (SiOx), foil, ACLAR® polychlorotrifluoroethylene (PCTFE), polyvinyl alcohol (PVOH), aluminum oxide (Alox), Silicon Oxide-F (SiOx-F) and polyethylene terephthalate (PET), metal, glass, plastic, polymers and ceramics.
26 . The kit of claim 21 , wherein the outer chamber is compatible with sterilization techniques selected from the group consisting of ethylene oxide sterilization, gamma radiation sterilization and e-beam radiation sterilization.
27 . The kit of claim 21 , wherein the outer chamber includes a transparent portion for visualization of the medical implant container within.
28 . The kit of claim 21 , further comprising a mechanical insert configured to engage the medical implant container and reduce stress imparted on the medical implant container when under the second vacuum.
29 . The kit of claim 28 , wherein the mechanical insert is a rigid material selected from the group consisting of rigid polymer plastics, polystyrene, polypropylene, metal, and acrylonitrile butadiene styrene plastic.
30 . A medical graft storage system, comprising:
at least one freeze-dried or dehydrated medical graft;
a hermetically sealed medical implant container comprising:
at least one graft cavity configured to store at least one graft under a first sustained vacuum;
top, side, and bottom walls defining an inner surface of the container;
a lip surrounding a periphery of the graft cavity with the top wall hermetically sealed to the lip adjacent the substrate cavity periphery; and
a needle entry port in fluid communication with the at least one graft cavity, the needle entry port being configured to receive and communicate a material to the at least one graft cavity; and
an outer chamber configured to store the medical implant container under a second sustained vacuum.
31 . The system of claim 30 , wherein the first vacuum and second vacuum are between 1 and 30 inHg.
32 . The system of claim 30 , wherein the first vacuum and second vacuum are substantially the same.
33 . The system of claim 30 , wherein the first vacuum and second vacuum are not substantially the same.
34 . The system of claim 30 , wherein the outer chamber includes a transparent portion for visualization of the medical implant container within.
35 . The system of claim 30 , wherein the outer chamber is made of a material selected from the group consisting of silicon oxide (SiOx), foil, ACLAR® polychlorotrifluoroethylene (PCTFE), polyvinyl alcohol (PVOH), aluminum oxide (Alox), Silicon Oxide-F (SiOx-F) and polyethylene terephthalate (PET), metal, glass, plastic, polymers and ceramics.
36 . The system of claim 30 , further comprising a mechanical insert configured to engage the medical implant container and reduce stress imparted on the medical implant container when under the second vacuum.
37 . The system of claim 30 , wherein the material is a biological material.
38 . A system for loading bone morphogenetic material into a medical graft, comprising:
a hermetically sealed container comprising an entry port, a substrate cavity, and top, side and bottom walls defining an inner surface of the container, a lip surrounding a periphery of the substrate cavity and the top wall is hermetically sealed to the lip adjacent the substrate cavity periphery;
the entry port configured to receive the bone morphogenetic material;
the substrate cavity in communication with the entry port and having the medical graft stored and maintained under negative pressure,
wherein a container volume is substantially the same as a volume of the medical graft; and an outer chamber configured to store the medical implant container under a second sustained vacuum.
39 . The system of claim 38 , wherein the entry port is disposed near the middle of the medical graft within the substrate cavity
40 . The system of claim 38 , wherein the container further comprises one or more supporting members configured to elevate and support the container in a substantially stable position.