Endoscope reprocessing and sterilization system
First Claim
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1. An apparatus for sterilizing a medical instrument having a lumen, said apparatus comprising:
- (a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber, said fluid dispensing unit including a rotating arm unit rotatably mounted to one of said walls so as to be disposed within said reprocessing chamber, said rotating arm unit including at least one rotating arm member having an interior fluid passage fluidly connected to said fluid inlet, a plurality of orifices defined in said rotating arm member, said orifices being in fluid communication with said fluid passage, so that fluid can pass from said fluid inlet, through said fluid passage, through said orifices and into said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(f) a heater for controlling a temperature of said at least one chemical sterilant component; and
at least one medical instrument supporting cassette movably mounted within said reprocessing chamber.
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Abstract
A system for reprocessing and sterilizing a previously used endoscope having at least one lumen is disclosed. The reprocessing system includes a reaction chamber into which individual chemical components of a sterilant are transferred by pneumatic force. The system includes a central processor which controls the asynchronous reprocessing and sterilization of at least two endoscopes. A novel sterilant is also disclosed. Also disclosed is a combination of the sterilization device and the sterilant and methods of using the same.
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Citations
52 Claims
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1. An apparatus for sterilizing a medical instrument having a lumen, said apparatus comprising:
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(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber, said fluid dispensing unit including a rotating arm unit rotatably mounted to one of said walls so as to be disposed within said reprocessing chamber, said rotating arm unit including at least one rotating arm member having an interior fluid passage fluidly connected to said fluid inlet, a plurality of orifices defined in said rotating arm member, said orifices being in fluid communication with said fluid passage, so that fluid can pass from said fluid inlet, through said fluid passage, through said orifices and into said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(f) a heater for controlling a temperature of said at least one chemical sterilant component; and
at least one medical instrument supporting cassette movably mounted within said reprocessing chamber. - View Dependent Claims (2, 3, 4)
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5. An apparatus for sterilizing a medical instrument having a lumen, said apparatus comprising:
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(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber, said fluid dispensing unit including a rotating arm unit rotatably mounted to one of said walls so as to be disposed within said reprocessing chamber, said rotating arm unit including at least one rotating arm member having an interior fluid passage fluidly connected to said fluid inlet, a plurality of orifices defined in said rotating arm member, said orifices being in fluid communication with said fluid passage, so that fluid can pass from said fluid inlet, through said fluid passage, through said orifices and into said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit; and
(f) a reaction vessel; and
wherein at least one said sterilant conduit extends between and fluidly couples each said chemical sterilant component container to said reaction vessel, at least one said sterilant conduit extends between and fluidly couples said reaction vessel and said reprocessing chamber; and
the transfer control system selectively transfers at least one chemical sterilant component from said at least one chemical sterilant component container to said reaction vessel, and selectively transfers sterilant from said reaction vessel to said reprocessing chamber.- View Dependent Claims (6, 7, 8, 9, 10, 11)
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12. An apparatus for sterilizing a medical instrument having a lumen, said apparatus comprising:
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(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(f) a reaction vessel; and
wherein at least one said sterilant conduit extends between and fluidly couples each said chemical sterilant component container to said reaction vessel, at least one said sterilant conduit extends between and fluidly couples said reaction vessel and said reprocessing chamber; and
the transfer control system selectively transfers at least one chemical sterilant component from said at least one chemical sterilant component container to said reaction vessel, and selectively transfers sterilant from said reaction vessel to said reprocessing chamber; and
(g) a chemical concentration detector, said chemical concentration detector being located within said reaction vessel and operatively connected to said central processor. - View Dependent Claims (13)
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- 14. An apparatus according to clam 12, wherein said chemical concentration detector includes a source of light energy and at least one of a window or notch through which said light energy is directed at a fluid sample to be measured.
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24. An apparatus for sterilizing a medical instrument lumen, said apparatus comprising:
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(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(f) a reaction vessel; and
wherein at least one said sterilant conduit extends between and fluidly couples each said chemical sterilant component container to said reaction vessel, at least one said sterilant conduit extends between and fluidly couples said reaction vessel and said reprocessing chamber; and
the transfer control system selectively transfers at least one chemical sterilant component from said at least one chemical sterilant component container to said reaction vessel, and selectively transfers sterilant from said reaction vessel to said reprocessing chamber; and
(g) a load sensor, said load sensor being connected to said reaction vessel and being operatively connected to said central processor for sensing and indicating an amount of material in said reaction vessel.
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25. The apparatus for sterilizing a medical instrument having a lumen, said apparatus comprising:
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(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing chamber;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing chamber;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween; and
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit, wherein said at least one chemical sterilant component container comprises a first component container and a second component container, in combination with a sterilant, said sterilant comprising;
an anti-microbial two-part concentrate system comprising;
a first component comprising hydrogen peroxide and water;
a second component comprising formic acid and water;
a block copolymer of ethylene oxide and propylene oxide, said block copolymer being present in said first component, said second component, or said first and second components;
phosphoric acid present in said first component, said second component, or said first and second components; and
benzotriazole present in said first component, said second component, or said first and second components, wherein, prior to mixture to form said sterilant, said first component and said second component are respectively contained in said first component container and said second component container. - View Dependent Claims (26, 27, 28, 29, 30, 31)
said second component comprises about 25 wt % to about 95 wt % of said formic acid, about 3 wt % to about 12 wt % of said block copolymer, and about 4 wt % to about 20 wt % of said phosphoric acid, and said first component comprises about 30 wt % to about 50 wt % of said hydrogen peroxide, and about 2 wt % to about 10 wt % of said benzotriazole.
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28. The combination according to claim 27, wherein in the two-part concentrate system:
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said second component comprises about 25 wt % of said formic acid, about 3.3 wt % of said block copolymer, and about 5 wt % of said phosphoric acid, and the remainder water; and
said first component comprises about 50 wt % of said hydrogen peroxide, about 2.3 wt % of said benzotriazole, and the remainder water.
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29. The combination according to claim 25, wherein said two-part concentrate system is substantially free of an alcohol reactable with said formic acid to form an ester.
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30. The combination according to claim 25, wherein said two-part concentrate system is devoid of a sulfur-containing catalyst.
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31. The combination according to claim 25, wherein a ratio of said first component to said second component is 60:
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32. A method of sterilizing a medical instrument having a lumen, said method comprising:
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(I) providing an apparatus, said apparatus comprising;
(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing bay;
(iv) a fluid dispenser operatively coupled to said at least one fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing bay, said fluid dispenser including a rotating arm unit rotatably mounted to one of said walls so as to be disposed within said reprocessing chamber, said rotating arm unit including at least one rotating arm member having an interior fluid passage fluidly connected to said fluid inlet, a plurality of orifices being defined in said rotating arm member, said orifices being in fluid communication with said fluid passage, so that fluid can pass from said fluid inlet, through said fluid passage, through said orifices and into said reprocessing chamber, said fluid dispenser further including a medical instrument connector for providing a fluid tight connection to at least one lumen of a medical instrument disposed in the reprocessing bay for delivering fluid for sterilizing said at least one lumen of said medical instrument;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween;
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit; and
(f) a heater for controlling a temperature of said at least one chemical sterilant component;
(II) disposing a medical instrument to be sterilized in a said reprocessing bay;
(III) transferring at least one chemical sterilant component from said chemical sterilant component container to said reprocessing chamber; and
(IV) forcing said sterilant under pressure through said plurality of orifices into said reprocessing chamber to effectively sterilize said medical instrument; and
(V) flowing said sterilant through said medical instrument connector and through said at least one lumen of said medical instrument, said sterilant flow receiving a superimposed pulsating flow of air for producing a scrubbing action on a wall of said at least one lumen of the medical instrument. - View Dependent Claims (33, 34)
cleaning said medical instrument with soap, and rinsing said medical instrument with water.
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35. The method of sterilizing a medical instrument having a lumen, said method comprising:
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(I) providing an apparatus, said apparatus comprising;
(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing bay;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing bay;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween; and
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(II) disposing a medical instrument to be sterilized in a said reprocessing bay;
(III) transferring at least one chemical sterilant component from said chemical sterilant component container to said reprocessing chamber; and
(IV) forcing said sterilant under pressure through said fluid dispensing unit and through said plurality of orifices into said reprocessing chamber to effectively sterilize said medical instrument, further comprising a reaction vessel and at least two chemical sterilant component containers, each of said containers containing one part of a two-part chemical sterilant concentrate system to be prepared in said reaction vessel; and
wherein at least one said sterilant conduit extends between and fluidly couples each said chemical sterilant component container to said reaction vessel, at least one said sterilant conduit extends between and fluidly couples said reaction vessel and said reprocessing chamber; and
the transfer control system selectively transfers said chemical sterilant components from said at least two chemical sterilant component container to said reaction vessel, and selectively transfers sterilant prepared in said reaction vessel from said reaction vessel to said reprocessing chamber and further comprising the steps of;
preparing a sterilant in said reaction vessel;
transferring said sterilant from said reaction chamber to a said reprocessing bay. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
calculating a dilution measurement amount of water in the central processor; and
transferring said dilution measurement amount of water to said reaction vessel.
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41. The method of claim 39, wherein said central processor is programmable to effect an apparatus self-sterilization cycle after completion of medical instrument sterilization.
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42. The method of claim 41, after forcing said sterilant under pressure further comprising:
self-sterilizing said apparatus.
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43. A method as in claim 35, further comprising detecting a leak in a jacket of the medical instrument by pressurizing the instrument jacket with a predetermined air pressure and monitoring air pressure loss to determine the presence of a leak.
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44. A method of sterilizing a medical instrument as in claim 43, wherein a leak is determined by comparing monitored air pressure loss to predetermined values.
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45. A method of sterilizing a medical instrument as in claim 43, wherein when a leak is detected, operation is terminated and a leakage message is presented.
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46. A method as in claim 35, wherein the transfer control system includes a compressed air source, said compressed air source being pneumatically connected to said chemical sterilant component container, wherein said compressed air source has a capacity to provide sufficient air pressure to said chemical sterilant component container to selectively effect transfer of said chemical sterilant component from said chemical sterilant component container through said sterilant conduit, and wherein said transferring step includes providing compressed air from said compressed air source to said chemical sterilant container and using the pressurized air to transfer the chemical component.
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47. A method of sterilizing a medical instrument having a lumen, said method comprising:
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(I) providing an apparatus, said apparatus comprising;
(a) at least one reprocessing bay, each said bay comprising;
(i) walls and a door together defining an interior reprocessing chamber, said door providing selective access to said reprocessing chamber;
(ii) at least one fluid inlet;
(iii) a fluid outlet permitting removal of accumulated fluid in said reprocessing bay;
(iv) a fluid dispensing unit operatively coupled to at least one said fluid inlet for at least one of spraying fluid onto and flushing fluid through a lumen of a medical instrument disposed in said reprocessing bay;
(b) at least one chemical sterilant component container;
(c) at least one sterilant conduit extending between and fluidly coupling said at least one chemical sterilant component container to said reprocessing chamber;
(d) at least one water conduit fluidly coupling a water supply to at least one of said reprocessing chamber, said at least one chemical sterilant component container, and the conduits extending therebetween; and
(e) a transfer control system for selectively transferring at least one chemical sterilant component from said at least one chemical sterilant component container to said reprocessing chamber, and for selectively transferring water from a water supply through said at least one water conduit;
(II) disposing a medical instrument to be sterilized in a said reprocessing bay;
(III) transferring at least one chemical sterilant component from said chemical sterilant component container to said reprocessing bay;
(IV) forcing said sterilant under pressure through said fluid dispensing unit to effectively sterilize said medical instrument;
(V) releasing a predetermined volume and pressure of air from an air reservoir;
(VI) flowing said volume of air to said lumen of said medical instrument;
(VII) monitoring an air pressure through said lumen; and
(VIII) determining, based on said monitored air pressure, a blockage of said lumen. - View Dependent Claims (48, 49, 50, 51, 52)
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Specification