Claims for Patent: 6,582,654

Summary for Patent: 6,582,654

Title:	Fluid spray system for cleaning and sterilizing medical devices supported on a rack
Abstract:	A fluid delivery system (20) for an automated processor (A) includes spray nozzles (102, 104, 106, 108, 110) for sequentially spraying washing, microbial decontaminant and rinsing solutions over a lumened device (B), such as an endoscope. The fluid delivery system also includes connection ports (150, 152, 154) for connecting with internal passages (187) of the device to deliver the washing and microbial decontaminant solutions thereto. A removable rack (21), specially configured for the particular device, positions the device within a chamber (12). The spray nozzles are located on rear and side walls (114, 116, 118) and on a door (18) of the chamber, such that the device is impinged with spray from all directions. Sets (102, 104) of the spray nozzles are pulsed in sequence so that the spray jets (122) do not cancel each other out. Leaking connectors (184) connect the automated processor connection ports with inlet ports (196) of the device and allow a portion of the cleaning, decontaminant, and rinsing solutions to leak from each inlet port. A computer control system (80) controls cleaning, decontamination, rinsing, and drying stages of a cycle, which are all carried out within the chamber, obviating the need for human contact with the device during processing.
Inventor(s):	Kral; Jude A. (Twinsburg, OH), Priest; Robert M. (Eastlake, OH), Kelsch; Daniel N. (Fairview Park, OH), Hlebovy; James C. (Chardon, OH), Sanford; Bill R. (Willoughby, OH), Greszler; Alan J. (Elyria, OH), Zelina; Francis John (Lake City, PA), Klobusnik; Kenneth J. (Lake City, PA)
Assignee:	Steris Inc. (Temecula, CA)
Application Number:	09/498,869
Patent Claims:	1. A system for cleaning and microbially decontaminating a device with at least one internal passage, the system including: a chamber for receiving the device in a vertical orientation; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the device; at least one connection port disposed within the chamber for supplying the decontaminant solution to the internal passage; a fluid distribution system connecting the source of the decontaminant solution, the chamber, and the nozzles and connection port, the distribution system delivering the decontaminant solution to the nozzles and connection port and receiving sprayed decontaminant solution from the chamber; a pump, connected with-the fluid distribution system which pumps the decontaminant solution to the nozzles and connection port; and a removable rack, removably hanging within the chamber, for suspending the device in the vertical orientation, such that decontaminant solution sprayed from the nozzles drips from the device, the rack having a plurality of pegs which define a curve. 2. A system for cleaning and microbially decontaminating an endoscope, the system comprising: a chamber for receiving the endoscope; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the endoscope; at least one connection port disposed within the chamber for supplying the decontaminant solution to an internal passage of the endoscope; a fluid distribution system connecting the source of the decontaminant solution, the chamber, and the nozzles and connection port, the distribution system delivering the decontaminant solution to the nozzles and connection port and receiving sprayed decontaminant solution from the chamber; a pump, connected with the fluid distribution system which pumps the decontaminant solution to the nozzles and connection port; a removable rack, supported within the chamber, for positioning the endoscope within the chamber; an endoscope clip which releasably couples a tip portion of the endoscope to one of the rack and another portion of the endoscope, to keep the tip portion securely positioned, the clip being adapted for interconnection with the fluid distribution system and including: at least one upper finger and at least one lower finger, apertures defined in the fingers for delivering decontaminant solution to portions of the endoscope contacted by the fingers, and a fluid pathway inside the clip which connects the fluid distribution system with the apertures; and a control system which controls the delivery of the decontaminant solution to the nozzles and connection port. 3. A system for cleaning and microbially decontaminating a device, the system comprising: a chamber for receiving the device; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the device; a pump which pumps the decontaminant solution to the nozzles; and a control system which controls the delivery of the decontaminant solution to the nozzles, the control system sequentially causing a first set of the spray nozzles to spray the decontaminant solution for a first period of time and then causing a second set of the spray nozzles to spray the decontaminant solution for a second period of time. 4. The system of claim 3, further including a nozzle assembly disposed adjacent a geometric center of the chamber that sprays radially outward. 5. The system of claim 4, wherein the nozzle assembly includes at least one of: a plurality of stationary nozzles mounted on a central support and directed radially outward; and a rotating nozzle. 6. The system of claim 3, wherein the nozzles of the first and second sets are aimed such that their spray patterns cross. 7. A system for cleaning and microbially decontaminating a device with at least two internal passages, the system comprising: a chamber for receiving the device; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the device; at least two connection ports disposed within the chamber for interconnection with the at least two internal passages for supplying the decontaminant solution to the at least two internal passages; a fluid distribution system connecting the source of the decontaminant solution, the chamber, and the nozzles and connection ports, the distribution system delivering the decontaminant solution to the nozzles and connection ports and receiving sprayed decontaminant solution from the chamber, the fluid distribution system including: a first fluid pathway connected with a first connection port; a first regulator regulating the pressure of the decontaminant solution flowing through the first fluid pathway to a first internal passage of the device; a second fluid pathway connected with at least a second connection port; and a second regulator regulating the pressure of the decontaminant solution flowing through the second fluid pathway to a second internal passage of the device, such that maximum pressure ratings of the first and second internal passages are not exceeded; a pump, connected with the fluid distribution system which pumps the decontaminant solution to the nozzles and connection ports; and a control system which controls the delivery of the decontaminant solution to the nozzles and connection ports. 8. The system of claim 7, further including: a housing which supports the first chamber and the second chamber adjacent each other with an operator input panel mounted adjacent the first and second chambers. 9. The system of claim 7, wherein the input panel includes a first display for indicating a status of a washing/decontamination cycle in the first chamber and a second display for indicating a status of a washing/decontamination cycle in the second chamber. 10. The system of claim 7, further including: a sterile water generator connected with the fluid distribution system which sterilizes unsterile water and supplies the sterile water to the nozzles and connection ports for rinsing the device. 11. The system of claim 7, further including: an air inlet connected with the fluid distribution system, for supplying filtered air to the spray nozzles and connection ports to dry the device. 12. A system for cleaning and microbially decontaminating an endoscope, the system comprising: a chamber for receiving the endoscope; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the endoscope; a fluid distribution system connecting the source of the decontaminant solution, the chamber, and the nozzles, the distribution system delivering the decontaminant solution to the nozzles and receiving sprayed decontaminant solution from the chamber; a valve reprocessor connected with the fluid distribution system, for receiving an endoscope valve, the reprocessor opening the valve while flowing the solution over and through the valve; a pump, connected with the fluid distribution system which pumps the decontaminant solution to the nozzles and valve reprocessor; and a control system which controls the delivery of the decontaminant solution to the nozzles and valve reprocessor. 13. A system for cleaning and microbially decontaminating an endoscope, the system comprising: a chamber for receiving the endoscope, the chamber including: stationary rear, two opposed side, and top panels and an open front adjacent the side panels that is closed by an access door, the side panels being spaced by greater than a minimum bend diameter of the endoscope; a rack supported by the rear panel and configured to support the endoscope in a coiled configuration on a plurality of pegs; a source of a microbial decontaminant solution; spray nozzles, disposed within the chamber, for spraying the decontaminant solution over an external surface of the endoscope, the spray nozzles including a plurality of nozzles mounted to the side panels and at least one of the door and rear panels for spraying the endoscope with focused sprays from a multiplicity of directions; at least one connection port disposed within the chamber for supplying the decontaminant solution to the internal passage; a fluid distribution system connecting the source of the decontaminant solution, the chamber, and the nozzles and connection port, the distribution system delivering the decontaminant solution to the nozzles and connection port and receiving sprayed decontaminant solution from the chamber; a pump, connected with the fluid distribution system which pumps the decontaminant solution to the nozzles and connection port; and a control system which controls the delivery of the decontaminant solution to the nozzles and connection port. 14. The system of claim 13, wherein the control system controls delivery to the nozzles such that nozzles whose spray patterns cross and would interfere with each other are operated alternately. 15. The system of claim 13, wherein the chamber defines a sump at the bottom thereof, the delivery system being connected with the sump for recirculating liquids that drain from the exterior and internal passages of the endoscope and collect in the sump. 16. A method of cleaning and microbially decontaminating a flexible endoscope having at least one internal passage comprising: a) coiling an endoscope on a rack and hanging the rack vertically within a chamber; b) placing a valve of the endoscope in a valve reprocessor within the chamber; c) spraying a washing solution over the endoscope from nozzles within the chamber to remove soil from exterior surfaces of the endoscope, the washing solution draining from the endoscope and collecting in the chamber below the endoscope; d) delivering the washing solution to the internal passage of the endoscope to remove soil from the internal passage of the endoscope, the washing solution coursing through the internal passage and draining into the chamber below the endoscope; e) spraying a microbial decontaminant solution over the endoscope from nozzles within the chamber to microbially decontaminate the exterior surfaces of the endoscope; f) delivering the microbial decontaminant solution to the internal passage of the endoscope to microbially decontaminate the internal passage of the endoscope; and g) delivering the microbial decontaminant solution to the valve reprocessor, the reprocessor opening the valve while the microbial decontaminant solution flows over and through the valve. 17. The method of claim 16, wherein step a) includes: positioning the endoscope within the chamber such that spray jets of the washing solution and the microbial decontaminant solution from the nozzles impinge on exterior surfaces of the endoscope during steps b)and d), each of the exterior surfaces of the device being contacted with at least one spray jet at an angle of no more than 45 degrees from perpendicular to the endoscope. 18. A method of cleaning and microbially decontaminating a flexible endoscope having at least one internal passage comprising: a) coiling the flexible endoscope around a rack and releasably coupling a tip portion of the endoscope to one of the rack and another portion of the endoscope with an endoscope clip to keep the tip portion securely positioned; b) positioning the rack and the endoscope within a chamber; c) spraying a washing solution over the endoscope from nozzles to remove soil from exterior surfaces of the endoscope; d) delivering the washing solution to the internal passage of the endoscope to remove soil from the internal passage of the endoscope; e) spraying a microbial decontaminant solution over the endoscope from nozzles within the chamber to microbially decontaminate the exterior surfaces of the endoscope; f) delivering the microbial decontaminant solution to the internal passage of the endoscope to microbially decontaminate the internal passage of the endoscope; and g) delivering the microbial decontaminant solution to an internal fluid path in the clip, the solution passing through apertures in the clip to contact the endoscope, spray jets of the washing solution and the microbial decontaminant solution from the nozzles impinging on exterior surfaces of the endoscope during steps c)and e). 19. The method of claim 18, wherein the step of positioning the endoscope includes: mounting the endoscope on the rack and positioning the rack mounted endoscope in the chamber. 20. The method of claim 19, wherein the device is an endoscope and the step of mounting the device on the rack includes: coiling the endoscope on the rack. 21. The method of claim 20, further including after a microbial decontamination cycle: lifting the rack from the chamber to remove the rack and the endoscope as a unit. 22. A method of cleaning and microbially decontaminating a device having at least one internal passage comprising: a) positioning the device within a chamber; b) spraying a washing solution over the device from nozzles within the chamber to remove soil from exterior surfaces of the device; c) delivering the washing solution to the internal passage of the device to remove soil from the internal passage of the device; d) spraying a microbial decontaminant solution over the device from nozzles within the chamber to microbially decontaminate the exterior surfaces of the device; e) delivering the microbial decontaminant solution to the internal passage of the device to microbially decontaminate the internal passage of the device; and during steps b) and d): pulsing at least two sets of the nozzles in sequence such that the device is impacted by spray jets from one set of nozzles for a first period of time and is then impacted by spray jets from another set of nozzles for a second period of time, the pulsing causing the device to wobble, changing points of contact of the device. 23. A method of cleaning and microbially decontaminating a device having internal passages comprising: a) positioning the device within a chamber; b) spraying a washing solution over the device from nozzles within the chamber to remove soil from exterior surfaces of the device; c) supplying the washing solution to a first internal passage of the device at a first washing solution pressure; d) supplying the washing solution to a second internal passage of the device at a second washing solution pressure, different from the first washing solution pressure; e) spraying a microbial decontaminant solution over the device from nozzles within the chamber to microbially decontaminate the exterior surfaces of the device; f) supplying the decontaminant solution to the first internal passage at a first decontaminant solution pressure; g) supplying the decontaminant solution to the second internal passage at a second decontaminant solution pressure, different from the first decontaminant solution pressure. 24. The method of claim 22, further including: controlling steps b), c), d), e) with a computer control system. 25. The method of claim 24, wherein the control system asynchronously controls steps b), c), d), and e) in at least one additional chamber. 26. The method of claim 22, further including, prior to steps d) and e): spraying a pretreatment solution over the device which includes a buffering agent and a corrosion inhibitor. 27. The method of claim 22, further including, after step e): spraying a sterile rinse water from nozzles within the chamber over exterior surfaces of the device; and delivering sterile rinse water to the internal passage of the device. 28. The method of claim 22, further including, after step e): blowing air from nozzles within the chamber over exterior surfaces of the device; and delivering air to the internal passage of the device.

Details for Patent 6,582,654

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