Package making – Methods – With contents treating
Reexamination Certificate
2000-10-11
2004-05-25
Gerrity, Stephen F. (Department: 3721)
Package making
Methods
With contents treating
C053S432000, C053S440000, C128S898000, C260S66500B, C623S023630
Reexamination Certificate
active
06739112
ABSTRACT:
TECHNICAL FIELD
The present invention relates to allograft packaging systems, and more particularly to bone allograft packaging systems.
BACKGROUND OF THE INVENTION
Bone allografts are used in a variety of medical procedures, e.g., spinal fusion procedures. Such bone allografts need first to be processed at a sanctioned facility and then are provided to medical facilities that perform the procedures. These processing facilities may shape bone allografts and then package them for transportation to medical facilities. Commonly, the bone allografts are either: (1) fresh frozen or (2) freeze dried prior to packaging and transportation to a medical facility. Disadvantages exist with both of these approaches. Specifically, fresh frozen bone allografts must be continuously stored at low temperatures (ie: frozen) both when stored and when transported to the medical facility to ensure their suitability for future medical procedures. Disadvantages of requiring such refrigerated storage include both the cost incurred in operating such equipment and the preparation time required in thawing the allografts for use at the start of the medical procedure. On the other hand, when using freeze dried bone allografts, the bone allografts must be re-hydrated prior to use in a medical procedure (which may require some time). Moreover, during the re-hydration process, the bone allograft must be kept in a sterile environment. Due to the time required either to thaw fresh frozen bone allografts or to re-hydrate freeze dried bone allografts, the thawing/re-hydration of the allografts must be commenced a period of time prior to actually starting the medical procedure, thus increasing the overall time required to perform the surgical procedure.
A further disadvantage of using a freeze dried bone allograft is that the freeze-drying process reportedly reduces the mechanical properties of the bone (for example, its compressive strength and rigidity). Rehydrating the bone is reported to restore only about 90% of the original properties, and this restoration is dependent on physician compliance with the rehydration process.
Moreover, in certain medical procedures the size or shape of the bone allograft required may not be known a priori. Consequently, several different size/shape bone allografts may need to be thawed/re-hydrated prior to the medical procedure. Those allografts not used during the procedure then need to be discarded. This is an inefficient use of a limited resource (bone allograft) and is time consuming. Accordingly, a need exists for an improved system for packaging bone allografts for future medical procedures, and in particular a system in which the allografts can be readied for surgical use much more quickly than with existing methods.
The present invention includes systems for packaging and storing bone allograft material for future use in a medical procedure. In accordance with the present invention, the bone allograft may be placed in a container. In various aspects of the invention, this container may comprise glass, plastic, or a metal foil. A saline solution may be added to the container. In one aspect of the invention, the amount of saline solution added is preferably just sufficient to keep the bone allograft hydrated. In one preferred aspect of the invention, the saline solution is saturated with minerals to minimize the leaching of minerals from the bone over time. The saturation of the saline solution may be accomplished with any combination of minerals, including, but not limited to, calcium, phosphate and magnesium.
After placing the bone allograft in a saline solution in the container, the container may then optionally be closed with an airtight seal. Prior to the medical procedure, the bone allograft is then simply removed from the container for use. In one optional aspect of the invention, the bone allograft may be sealed in a container with solution then added to the container via a self-sealing valve. In one approach, air may be vacuumed from the container prior to closing the container. When using this approach, a “shrink-wrap” type of container may be used in which the container conforms to the shape of the allograft as the air is vacuumed out.
Although not required by the present invention, the bone allograft may optionally be freeze-dried as well prior to insertion in the container where it is then re-hydrated and kept hydrated. An advantage of such optional freeze-drying is that it may reduce the antigenicity of the bone allograft.
Advantages of the present system of bone allograft storage packaging include the elimination of refrigeration requirements, thereby providing allografts which can be quickly prepared for use by a physician when performing a medical procedure. This reduces the overall cost of system operation as refrigeration equipment is not required, either when storing or transporting the allograft material. A second advantage is that considerable time is not wasted in thawing or re-hydrating the allograft material before transplanting it into a patient.
Preferably as well, the packaging material and the saline solution are sterilized such that the bone allograft can be removed ready for use in a sterilized condition.
REFERENCES:
patent: 4065816 (1978-01-01), Sawyer
patent: 5480424 (1996-01-01), Cox
patent: 5531791 (1996-07-01), Wolfinbarger, Jr.
patent: 5989498 (1999-11-01), Odland
patent: 6294187 (2001-09-01), Boyce et al.
Gerrity Stephen F.
Nu Vasive, Inc.
Spangler Jonathan
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