Claims for Patent: 5,690,958

Summary for Patent: 5,690,958

Title:	Unit dose chlorhexadine gluconate(CHG) applicator having extended CHG shelf life
Abstract:	A unit dose chlorhexadine gluconate (CHG) applicator is disclosed wherein a unit dose of the CHG is contained in a hermetically sealed manually crushable glass ampule that has an internal volume not significantly greater than the unit dose volume of the CHG. The CHG in the ampule has an effective shelf life of at least 24 months. The glass ampule of the applicator is preferably protected by a flexible cover to protect the user's hand during manual crushing of the ampule to release the CHG therefrom. In one embodiment of the invention, a cylindrical glass ampule is housed within a tubular, flexible synthetic resin cover which has a porous applicator swab at one end thereof. Upon crushing of the glass ampule, the CHG released therefrom impregnates the swab allowing the user to spread the CHG across an area to be sanitized. In a second embodiment of the invention, a cylindrical glass ampule is received within a semi-cylindrical, open-sided body cover having a flange portion that mounts a sponge-like swab communicating with the interior of the body cover. Opposed integral wing-like gripping members on the ampule permit the user to crush the ampule by squeezing the members toward one another whereupon the CHG is released from the ampule and impregnates the sponge swab. The swab soaked with the CHG antiseptic may be rubbed across an area to be sanitized.
Inventor(s):	McGrath; Patrick D. (Lenexa, KS)
Assignee:	Medi-Flex Hospital Products, Inc. (Overland Park, KS)
Application Number:	08/723,686
Patent Claims:	1. A bactericidal agent dosage applicator having an extended shelf life comprising: a unit dose of chlorhexadine gluconate; and a manually crushable glass ampule containing said unit dose of chlorhexadine gluconate, the internal volume of said ampule not being significantly greater than the volume of said unit dose, said glass ampule having an extremity which was closed at the time of filling of the ampule with the chlorhexadine gluconate and an extremity which was heat-sealed after filling of the ampule with the chlorhexadine gluconate to provide a hermetic closure for the ampule. 2. A bactericidal agent dosage applicator as set forth in claim 1 wherein said heat-sealed extremity of the ampule was subjected to a flame sufficient to melt the glass and provide the hermetic closure. 3. A bactericidal agent dosage applicator as set forth in claim 1 wherein said glass ampule is of generally cylindrical shape and said extremities are at opposite ends thereof. 4. A bactericidal agent dosage applicator as set forth in claim 1 wherein said glass ampule containing the chlorhexadine gluconate unit dose was subjected to elevated temperature sterilization after introduction of the chlorhexadine gluconate into the interior thereof and hermetic sealing of the ampule. 5. A bactericidal agent dosage applicator as set forth in claim 1 wherein is provided a flexible cover over said glass ampule to protect the user's hand during manual crushing of the ampule to release the chlorhexadine gluconate therefrom. 6. A bactericidal agent dosage applicator as set forth in claim 5 wherein is provided means associated with said flexible cover for causing the chlorhexadine gluconate to be directionally released from the ampule upon manual crushing of the latter. 7. A bactericidal agent dosage applicator as set forth in claim 5 wherein said cover has an opening therein communicating with the exterior surface of the ampule, and a porous applicator swab carried by the cover and extending through said opening. 8. A bactericidal agent dosage applicator as set forth in claim 5 wherein said ampule is elongated and the cover has an opening therein extending along the longitudinal length of the ampule, and applicator sponge means on the cover extending along the length of the opening therein in disposition to receive chlorhexadine gluconate released from the ampule upon crushing thereof. 9. A method of preparing a bactericidal agent dosage applicator having an extended shelf life comprising: providing a manually crushable glass ampule having a closed extremity and an initially open extremity; introducing a unit dose of chlorhexadine gluconate into the ampule, said ampule having an internal volume not significantly greater than the unit dose volume of the chlorhexadine gluconate; and subjecting the initially open extremity of the ampule to heat at a temperature and for a time sufficient to melt the glass defining said initially open extremity and form a closure therefor upon cooling of the heated glass to effect hermetic sealing of the chlorhexadine gluconate within the ampule. 10. A method of preparing a bactericidal agent dosage applicator as set forth in claim 9 wherein is included the step of subjecting the glass ampule containing the chlorhexadine gluconate unit dose to elevated temperature sterilization prior to heat sealing of the ampule. 11. A method of preparing a bactericidal agent dosage applicator as set forth in claim 10 wherein said sterilization step includes subjecting the glass ampule containing the chlorhexadine gluconate unit dose to a temperature of from about 120.degree. F. to about 140.degree. F. 12. A method of preparing a bactericidal agent dosage applicator as set forth in claim 9 wherein heat sealing of said initially open extremity of the ampule is effected by subjecting such extremity to an open flame. 13. A method of preparing a bactericidal agent dosage applicator as set forth in claim 9 wherein is included the step of placing a flexible cover over the hermetically sealed glass ampule to protect the user's hand during manual crushing of the ampule to release the chlorhexadine gluconate therefrom. 14. A method of preparing a dosage unit of chlorhexadine gluconate and of conducting an accelerated test to verify that such dosage unit has an extended shelf life of at least about twenty-four months comprising the steps of: providing a manually crushable glass ampule having a closed extremity and an initially open extremity; introducing a unit dose of chlorhexadine gluconate into the ampule, said ampule having an internal volume not significantly greater than the unit dose volume of the chlorhexadine gluconate; subjecting the initially open extremity of the ampule to heat at a temperature and for a time sufficient to melt the glass defining said initially open extremity and form a closure therefor upon cooling of the heated glass to effect hermetic sealing of the chlorhexadine gluconate within the ampule; placing the hermetically sealed ampule in a elevated temperature environment of about 40.degree. C. for approximately three months; and thereafter breaking the ampule, recovering a sample of the chlorhexadine gluconate contained therein and testing such sample to determine the extent of degradation if any of the chlorhexadine gluconate unit dose.