Claims for Patent: 6,585,943

Summary for Patent: 6,585,943

Title:	Liquid cleaning and sterilization system
Abstract:	A fluid delivery system (26) for an automated processor (A) delivers washing, microbial decontaminant, and rinse fluids to spray nozzles (102, 104, 106, 108, 110) in a chamber (12) for sequentially spraying the fluids over a lumened device (B), such as an endoscope. The fluid delivery system also delivers the fluids to connection ports (150, 152, 154) which connect with internal passages (187) of the device for delivering the fluids thereto. Leaking connectors (184) connect the automated processor connection ports with inlet ports (196) of the device and allow a portion of the washing, 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. A door locking and latching mechanism (90) ensures that the door remains locked during the washing, decontamination, and rinse cycle to avoid accidental injury to an operator from strong chemicals used in the system.
Inventor(s):	Sanford; Bill R. (Willoughby, OH), Kral; Jude A. (Twinsburg, OH), Tvergyak; Joseph (Chardon, OH), Moss; Bernard J. (Willowick, OH), Priest; Robert M. (Eastlake, OH), Hlebovy; James C. (Chardon, OH), Kelsch; Daniel N. (Fairview Park, OH), Greszler; Alan J. (Elyria, OH), Minerovic; David E. (Concord, OH), Houston; John C. (Erie, PA), Robinson; Nancy A. (Hudson, OH)
Assignee:	Steris Inc. (Temecula, CA)
Application Number:	09/498,811
Patent Claims:	1. An automated system for cleaning and microbially decontaminating a device, the automated system comprising: a cabinet which defines an interior chamber for receiving the device; spray nozzles, disposed within the chamber, for spraying a washing fluid and a microbial decontaminant fluid over an external surface of the device; a source of rinse water; a source of the washing fluid; a source of the microbial decontaminant fluid; a fluid distribution system fluidly connecting the sources of rinse water, washing fluid, and microbial decontaminant fluid with the nozzles; a pump connected with the fluid distribution system for pumping the washing fluid, microbial decontaminant fluid, and rinse water, to the nozzles; a control system which controls the delivery of the washing fluid, microbial decontaminant fluid, and rinse water to the nozzles such that the device is sequentially washed with the washing fluid, microbially decontaminated with the microbial decontaminant fluid, and rinsed with the rinse water; connection ports, within the chamber, connected with the fluid distribution system, for connecting with an internal passage of the device such that the internal passage is sequentially washed with the washing fluid, microbially decontaminated with the microbial decontaminant fluid, and rinsed with the rinse water; and a non-porous connector for connecting the connection port to the internal passage of the device, the connector being configured to flow a portion of the microbial decontaminant fluid through a gap between the non-porous connector and an adjacent surface of the internal passage of the device into the chamber to ensure contact of the microbial decontaminant fluid with the adjacent surface. 2. The automated system of claim 1, further including a sump which receives sprayed washing and decontaminant fluids, the fluid distribution system fluidly connecting the sump and the nozzles for returning the sprayed fluids to the nozzles. 3. The automated system of claim 2, further including a drain valve, fluidly connecting a drain with the fluid distribution system, the controller selectively operating the opening of the drain valve to release the washing fluid and then the microbial decontaminant fluid to the drain. 4. The automated system of claim 1, wherein the source of rinse water includes: a sterile water generator fluidly connected with the nozzles which sterilizes unsterile water and supplies the sterile water to the nozzles and connection ports for rinsing the device, the control system controlling the timing of the delivery of the sterile water. 5. The system of claim 1, further including: a connection port within the chamber, the connection port adapted for connection with an internal passage of the device; a leak detector, fluidly connected with the connection port, which pressurizes the internal passage with a gas for detecting leaks between a sheath and lumens of the device, the control system selectively controlling the operation of the leak detector. 6. An automated system for cleaning and microbially decontaminating a device, the automated system comprising: a cabinet which defines an interior chamber for receiving the device; spray nozzles, disposed within the chamber, for spraying a washing fluid and a microbial decontaminant fluid over an external surface of the device; a well which receives a package, the package including: a measured dose of a concentrated cleaning agent which forms the washing fluid on mixing with water, and a measured dose of a concentrated microbial decontaminant which forms the microbial decontaminant fluid on mixing with water, the concentrated microbial decontaminant being held separately in the package from the concentrated washing agent; a system for sequentially releasing first the concentrated cleaning agent and subsequently after distributing the first cleaning agent throughout the system, releasing the concentrated microbial decontaminant into the well; a water inlet, fluidly connected with the well, which supplies dilution water for mixing with the concentrated cleaning agent and concentrated microbial decontaminant; a fluid distribution system fluidly connecting the water inlet and well with the nozzles; a pump connected with the fluid distribution system for pumping the washing fluid and microbial decontaminant fluid to the nozzles; and a control system which controls the operation of the release system and delivery of the washing fluid and microbial decontaminant fluid to the nozzles such that the device is sequentially washed with the washing fluid and microbially decontaminated with the microbial decontaminant fluid. 7. The automated system of claim 6, further including: connection ports, within the chamber, connected with the fluid distribution system, for connecting with an internal passage of the device such that the internal passage is sequentially washed with the washing fluid, microbially decontaminated with the microbial decontaminant fluid, and rinsed with a rinse water. 8. The automated system of claim 6, wherein the package includes first and second compartments and the release system includes: an opening member which sequentially opens the first compartment to release the concentrated cleaning agent and the second compartment to release the concentrated microbial decontaminant, the control system controlling actuation of the opening member. 9. The automated system of claim 6, further including: a source of a pretreatment agent, the pretreatment agent including at least one of a buffering agent, a corrosion inhibitor, and a surfactant, the fluid distribution system fluidly connecting the source of the pretreatment agent with the nozzles, the control system controlling the release of the pretreatment agent into the fluid distribution system to pretreat the device with the pretreatment agent prior to decontamination with the microbial decontaminant. 10. The automated system of claim 9, the sources of the concentrated cleaning agent, concentrated pretreatment agent, and concentrated microbial decontaminant including: a well, fluidly connected with the fluid distribution system, the well receiving a three compartment package separately containing the concentrated cleaning agent, concentrated pretreatment agent, and concentrated microbial decontaminant. 11. The automated system of claim 6, wherein the decontaminant fluid includes peracetic acid. 12. The automated system of claim 6, wherein the washing fluid includes at least one of an enzymatic cleaner and a detergent. 13. The automated system of claim 1, further including: an air inlet, fluidly connected with the fluid distribution system, for supplying filtered air to the spray nozzles to dry the device. 14. The automated system of claim 1, wherein the chamber further includes a door which selectively seals an access opening to the chamber, the control system preventing opening of the door while the nozzles spray the decontaminant fluid over the device. 15. The system of claim 6, further including at least one of: a detector which detects the presence of a cleaner in the washing fluid; and a detector which detects the presence of a decontaminant in the decontaminant fluid. 16. An automated system for cleaning and microbially decontaminating a device, the automated system comprising: a cabinet which defines an interior chamber for receiving the device; spray nozzles, disposed within the chamber, for spraying a washing fluid and a microbial decontaminant fluid over an external surface of the device; a sump at a base of the chamber which receives sprayed washing and decontaminant fluids which have dripped off the device; a well which is integral with the sump, the well receiving a package, the package including: a measured dose of a concentrated cleaning agent which forms a washing fluid on mixing with water, and a measured dose of a concentrated microbial decontaminant which forms a microbial decontaminant fluid on mixing with water, the concentrated microbial decontaminant being held separately in the package from the concentrated washing agent; a system for sequentially releasing the concentrated cleaning agent, stopping the releasing of material from the package, and, at a later time after removal of the concentrated cleaning agent from the well, releasing concentrated microbial decontaminant from the package into the well; a water inlet, fluidly connected with the well, which supplies dilution water for mixing with the concentrated cleaning agent and concentrated microbial decontaminant; a fluid distribution system fluidly connecting the well with the nozzles; a pump connected with the fluid distribution system for pumping the washing fluid and microbial decontaminant fluid to the nozzles; and a control system which controls the delivery of the washing fluid and microbial decontaminant fluid to the nozzles such that the device is sequentially washed with the washing fluid and microbially decontaminated with the microbial decontaminant fluid. 17. An automated system for cleaning and microbially decontaminating a device, the automated system comprising: spray nozzles, disposed within a chamber, for spraying a washing fluid and a microbial decontaminant fluid over an external surface of the device; a well which receives a package, the package including: a first compartment holding a measured dose of a concentrated cleaning agent which forms a washing fluid on mixing with water, a second compartment holding a measured dose of a concentrated microbial decontaminant which forms a microbial decontaminant fluid on mixing with water, and a third compartment holding a measured dose of a concentrated pretreatment agent which forms a pretreatment fluid on mixing with water, the pretreatment agent including at least one of a buffering agent, a corrosion inhibitor, and a surfactant, for forming the pretreatment solution, the concentrated pretreatment agent being held separately in the package from the concentrated cleaning agent and the concentrated microbial decontaminant; an opening member which sequentially opens the first compartment to release the concentrated cleaning agent, the third compartment, to release the pretreatment agent, and the second compartment to release the concentrated microbial decontaminant; a fluid distribution system fluidly connecting the well with the nozzles; a control system which controls the delivery of the washing fluid, microbial decontaminant fluid, the control system controlling the operation of the opening member such that the concentrated pretreatment agent is released from the package into the well prior to release of the concentrated microbial decontaminant. 18. An automated system for cleaning and microbially decontaminating a device, the automated system comprising: a cabinet which defines an interior chamber for receiving the device; spray nozzles, disposed within the chamber, for spraying a microbial decontaminant fluid over an external surface of the device; a source of rinse water; a source of the microbial decontaminant fluid; a fluid distribution system fluidly connecting the sources of rinse water and microbial decontaminant fluid with the nozzles; a control system which controls the delivery of the microbial decontaminant fluid and rinse water to the nozzles; a door which selectively seals an access opening to the chamber, the control system preventing opening of the door while the nozzles spray the decontaminant fluid over the device; and a locking and latching mechanism, the locking and latching mechanism including: a latching mechanism which selectively moves from a latching position, in which the latching mechanism holds the door in a sealing relationship across the access opening, to an unlatched position, in which the latching mechanism allows opening of the door; a locking mechanism, which selectively allows unlatching of the latching mechanism in an unlocked position and locks the latching mechanism in a locked position, preventing opening of the door, the control system controlling movement of the locking mechanism between the unlocked and locked positions. 19. The automated system of claim 18, wherein the latching mechanism includes: an arm pivotally connected adjacent a first end thereof to the cabinet; a roller, rotatably connected to the arm and spaced from the first end, which engages an engagement member on an outer surface of the door in the latched position. 20. The automated system of claim 19, the locking mechanism further including: a rod which engages the arm in the locked position, preventing pivoting of the arm, and allows pivoting of the arm away from the engagement member in the unlocked position; and a driving member, the driving member driving the rod between the unlocked position and the locked position. 21. The automated system of claim 20, wherein the driving member includes an air cylinder.

Details for Patent 6,585,943

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