Claims for Patent: 5,204,004

Summary for Patent: 5,204,004

Title:	Method and apparatus for preventing bacteriological contamination by a dental tool water line
Abstract:	A method and apparatus are disclosed for preventing bacterial contamination from being introduced into a dental patient\'s mouth from water flowing through a dental tool water line. A flexible water line typically used for supplying water to a dental syringe, high-speed hand piece, or ultrasonic scaler has been found to support and encourage the growth of a significant biofilm that serves as a source of bacteria. To prevent the bacteria from being introduced into a patient\'s mouth by water flowing through the line, and thus into the patient\'s system, an in-line water filter is installed within the water line supplying water to the dental tool, at a point adjacent thereto. Conventional Luer fittings on the in-line water filter facilitate its quick installation and replacement. In addition, a cap protects the sterility of the outlet port of the in-line water filter during the installation process. The in-line water filter includes a microporous membrane that blocks bacteria and other particulate matter larger than approximately 0.2 microns, so that water flowing from the outlet port of the in-line water filter is substantially sterile.
Inventor(s):	Johnston; Simon E. (Kirkland, WA), Johnston; Anna M. (Kirkland, WA), Williams; Jeffrey F. (Mason, MI)
Assignee:
Application Number:	07/891,440
Patent Claims:	1. Apparatus for use in connection with dental tools that employ a water line for conveying water to a patient's mouth, said apparatus protecting a patient from bacteriological contamination that may be present in the water line, comprising: (a) a housing in which are formed an inlet port and an outlet port, said outlet port being in a sterile condition prior to use and installation of the apparatus in a water line; (b) a quick-connect inlet fitting formed on the inlet port; (c) a quick-connect outlet fitting formed on the outlet port; (d) means for bacteriological sterilization of water flow through the housing, including a microporous membrane having a porosity selected to block a predefined size of particulate matter, including bacteria, without substantially restricting water flow through the membrane, said membrane being disposed within the housing between the inlet port and the outlet port and sealingly extending between an internal periphery of the housing so that all water flowing in the inlet port passes through the membrane before flowing out the outlet port; and (e) a sterile cap sized to fit over the outlet port to protect it from being contaminated by exposure to a non-sterile environment when the housing is handled during installation in a water line, said apparatus being thus installable in a water line that has an internal surface capable of supporting a bacterial growth, so that bacteria within the water entering the inlet port are substantially blocked and prevented from reaching a patient's mouth through a dental tool used therein, said apparatus thereby protecting a patient from exposure to potentially harmful bacteria that might cause illness. 2. The apparatus of claim 1, wherein said quick-connect inlet and outlet fittings are Luer fittings. 3. The apparatus of claim 2, wherein the sterile cap has opposed distal ends, one distal end including a flange sized to engage the Luer fitting at the outlet port and the other distal end including means for enhancing a user's grip on the cap to facilitate decoupling and removal of the cap from the Luer fitting during installation of the apparatus into a water line supplying water to a dental tool. 4. The apparatus of claim 3, wherein the means for enhancing a user's grip on the cap enable the apparatus to be more readily rotated to connect a mating Luer fitting on a water line to the Luer fitting at the inlet port, said sterile cap being then removed to enable a user to connect a mating Luer fitting on a water line coupled to a dental tool to the Luer fitting at the outlet port, without contaminating the output port. 5. The apparatus of claim 1, further comprising a retrofit kit for modifying a water line coupled to a dental tool to include quick-connect fittings that are installable on ends of a water line cut adjacent to a dental tool, the quick-connect fittings thereby installed on each end of a water line that is thus cut mating with the quick-connect fittings on the inlet and the outlet ports, to adapt a water line to couple with the housing of the apparatus. 6. The apparatus of claim 5, further including instructions that define how a user should install the retrofit kit to enable use of the apparatus to filter bacteria from a line carrying water to a dental tool. 7. The apparatus of claim 1, wherein the housing has a substantially oblate-round shape, the inlet port and the outlet port being substantially centered within opposed surfaces of the housing. 8. The apparatus of claim 7, wherein the membrane is substantially planar and round, said housing comprising a first disk-like portion and a second disk-like portion that are sealed together around a periphery of the membrane, said membrane being thus sealingly disposed between the first and second portions, said quick-connect fittings extending outwardly in opposite directions from the first and second portions at the inlet and the outlet ports. 9. A method for minimizing bacteriological contamination of a patient's mouth from bacteria that may be present in a water line supplying water to a dental tool used in the patient's mouth, comprising the steps of: (a) cutting the water line adjacent to the dental tool, leaving a relatively short section of the water line coupled to the dental tool; (b) installing a quick-connect fitting on each end of the water line where it was cut; and (c) installing means for bacteriologically sterilizing water flow to the dental tool, including an in-line water filter having quick-connect fittings that mate with those installed in the water line in step (b), said in-line water filter substantially blocking bacteria from a biofilm that may exist in the water line upstream of the in-line water filter from being carried by the water into a patient's mouth. 10. The method of claim 9, further comprising the step of sterilizing an interior of the relatively short section of water line adjacent to the dental tool prior to installing the mating quick-connect fitting so that any bacteriological contamination existing therein is substantially eliminated. 11. The method of claim 9, further comprising the steps of providing a sterile outlet port on the in-line water filter and protecting the sterility of the outlet port with a cap that is removed during the installation of the water filter in the water line. 12. The method of claim 11, wherein the step of installing the in-line water filter includes the step of grasping the in-line water filter by the cap and connecting the quick-connect fitting that is on an inlet port thereof with the mating quick-connect fitting on the end of the water line, removing the cap, and then connecting the quick-connect fitting that is on the outlet port to the mating quick-connect fitting on the end of the relatively short section of the water line coupled to the dental tool, the sterility of the outlet port and of water subsequently flowing therethrough being thereby maintained. 13. The method of claim 9, further comprising the step of periodically replacing the in-line water filter to insure substantially unrestricted flow of water therethrough. 14. A method of removing bacteriological contamination from water that flows through an elastomeric line to a dental tool to provide sterile water at a patient's mouth, said bacteriological contamination being substantially produced by a bacterial growth in a biofilm that may exist on an interior surface of the elastomeric line, comprising the steps of: (a) installing means for bacteriologically sterilizing water flow to the dental tool into the elastomeric line at a point adjacent to the dental tool, said means comprising a readily replaceable in-line filter, said in-line filter including a microporous membrane having a porosity selected to filter particles and harmful bacteria from water flowing therethrough without substantially restricting water flow therethrough; (b) sterilizing at least an outlet port of the in-line filter prior to its installation in the elastomeric line, said outlet port being coupled to the dental tool by a section of the elastomeric line that is in a sterile condition prior to installation of the in-line filter; and (c) maintaining the sterility of the outlet port during installation of the in-line filter by using a cap to enclose the outlet port until immediately prior to coupling the outlet port to the dental tool, said in-line filter substantially blocking bacteria introduced by any bacterial growth in the elastomeric line upstream of the in-line filter from being introduced into a patient's mouth by the water flowing through the elastomeric line to the dental tool. 15. The method of claim 14, further comprising the step of providing quick-connect fittings on the elastomeric line that are selected to mate with quick-connect fittings on the in-line filter, to facilitate installation and replacement of the in-line filter. 16. The method of claim 14, further comprising the step of replacing the in-line filter on a predefined schedule to prevent it from becoming clogged with particulate matter. 17. The method of claim 14, further comprising the step of circulating a sterilizing fluid through the elastomeric line prior to installation of the in-line filter, said sterilizing fluid substantially reducing a bacterial count in a biofilm on an internal surface of the elastomeric line. 18. The method of claim 14, further comprising the step of providing a plurality of ridges on an exterior portion of the cap to facilitate a user gripping it to rotate the in-line filter to couple it to the quick-connect fitting on the elastomeric line and to decouple the cap from the quick-connect fitting on the in-line filter. 19. The method of claim 14, further comprising the step of providing a fitting on the cap that mates with the quick-connect fitting on the outlet port of the in-line filter, so as to engage the cap on the outlet port. 20. The method of claim 14, wherein the dental tool is one of a group consisting of a syringe, a high-speed handpiece, and an ultrasonic scalar.

Details for Patent 5,204,004

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23