Agitating – Operator supported – Mixing chamber type
Reexamination Certificate
2000-09-26
2002-04-02
Soohoo, Tony G. (Department: 1723)
Agitating
Operator supported
Mixing chamber type
C366S189000, C220S221000, C220S222000, C220S557000, C220S568000
Reexamination Certificate
active
06364519
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a bone cement system comprising a contoured cement powder storage container with a peel-off lid that facilitates safe and efficient access to the powder and an ampoule containing liquid monomer for combining with the cement powder to prepare the cement.
BACKGROUND OF THE INVENTION
Bone cement is prepared by mixing liquid monomer with cement powder. Such preparation must occur under sterilized conditions. To accomplish this, current powders are sterilized and packaged in a sealed pouch. The liquid is generally packaged in a glass ampoule. The pouch and ampoule are then packaged together and remain unopened until needed in the sterilized environment of the operating room.
The pouch and the ampoule hold the precise amounts of their respective cement components so that the nurse simply may combine the components in their pre-measured amounts to produce cement having optimum characteristics. To prepare the cement, a nurse opens the pouch by tearing or cutting the pouch with scissors or a scalpel blade and pours the powder into the mixing chamber of a cement mixer. The liquid is then mixed with the powder to produce the cement for use in surgery.
This technique can be both dangerous and inefficient, as well as jeopardize the quality of the resulting cement. The nurse, when using a knife or blade to open the pouch, may cut herself and, unbeknownst to her, contaminate the powder. Moreover, when tearing or cutting open the pouch, the pouch may be opened too forcefully or the pouch opening may be made too large, resulting in powder spilling from the pouch and consequent contamination of the powder. Finally, because the pouch provides no spout or other channel for guiding the powder, powder loss also occurs when attempting to pour the powder from the pouch into the mixing chamber.
In addition to possible waste of cement powder, the current packaging may also result in the loss of the liquid. When the pouch and ampoule are packaged together, the ampoule is generally not well secured in the packaging. In the operating room, nurses typically dump the contents out of the packaging and onto a tray. This can result in breakage of the fragile glass ampoule containing the liquid.
Because the pouch and the ampoule each contain the precise amount of a cement component (powder or liquid) for combination with the other cement component (liquid or powder), loss of an amount of either component compromises the desired powder/liquid ratio. The nurse is forced to guess how much of the un-spilled component to combine with the remnants of the spilled component to regain the desired ratio and thereby obtain the desired consistency of the cement.
SUMMARY OF THE INVENTION
The present invention addresses the above-described problems inherent in current packaging practices by providing a relatively rigid container for packaging the cement powder. The container is filled with the powder and then sealed with a lid. To access the powder, the nurse simply peels back the lid. Because no tearing or cutting is required as with the current pouches, the likelihood of powder loss and contamination is reduced. The container may be shaped to guide and/or mate with a funnel that guides the powder into the mixing chamber of the cement mixer. Additionally, the container may be shaped to allow for actual mixing of the powder and the liquid within the container. The liquid monomer is then simply added to the powder already in the container, drastically reducing the risk of powder loss and consequent detrimental effects.
It is an object of the present invention to provide a cement powder storage container that is safer to open than existing storage containers, thereby reducing the risk of powder contamination.
It is another object of the present invention to provide a cement powder storage container that is easier to open than existing storage containers, thereby reducing the risk of powder waste when opening of the container.
It is still another object of the present invention to provide a cement powder storage container that facilitates precise pouring of the powder from the container to reduce the risk of powder waste when dispensing the powder from the container.
It is a further object of the present invention to provide a cement powder storage container in which the powder and liquid monomer may be mixed.
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patent: 4673085 (1987-06-01), Badouard et al.
patent: 5203459 (1993-04-01), Wade
patent: 5333737 (1994-08-01), Clark
patent: 6003673 (1999-12-01), Vieu
Palacos R Radiopaque bone cement packaging (Cat. No. 12-0001)(Smith & Nephew) (undated).
VersaBond™ Radiopaque bone cement packaging (No. 7127-1140) (Smith & Nephew) (undated).
VersaBond™ with Gentamicin Radiopaque Polymer Powder packaging (Smith & Nephew) (undated).
VersaBond™ Medium Viscosity Cement “The Bond Between Strength and Versatility,” brochure (Smith & Nephew) (Jan. 2000).
Mix O.R.™ Vacuum Mixing System with Cartridge and Nozzle Packaging (Smith & Nephew (undated).
Hughes Christopher P.
Rocco Richard A.
Kilpatrick & Stockton LLP
Smith & Nephew Inc.
Soohoo Tony G.
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