FIELD

[0001] The subject matter disclosed herein relates to decontamination systems, particularly decontamination systems for decontaminating medical instruments.

BACKGROUND

[0002] Endoscopes are reusable medical devices. An endoscope should be reprocessed, i.e., cleaned and decontaminated, between medical procedures in which it is used to avoid causing infection or illness in a subject. Endoscopes are difficult to decontaminate as has been documented in various news stories. See, e.g., Chad Terhune, “Superbug outbreak: UCLA will test new scope cleaning machine,” LA Times, July 22, 2015, http://www.latimes.com/business/la-fi-ucla- superbug-scope-testing-20150722-story.html (last visited October 30, 2017).

[0003] One difficulty for reprocessing an endoscope arises when an endoscope must be coiled to fit into a decontamination system. Those portions of the endoscope that touch other portions of the endoscope or other materials within the sterilization chamber (e.g., a sterilization tray in which it is placed, a wall of the chamber, impermeable portions of a sterilization pouch) may be referred to as “shadowed surfaces.” Shadowed surfaces are difficult to clean and decontaminate relative to exposed, i.e., non-shadowed, surfaces because it is more difficult to contact the shadowed surfaces with cleaning and disinfectant solutions.

SUMMARY OF THE DISCLOSURE

[0004] A decontamination system, e.g., a reprocessor, particularly suitable for decontaminating medical devices, such as endoscopes, includes a spray nozzle assembly comprising a spray nozzle. The spray nozzle includes various features that enable improved cleaning and decontamination of those surfaces or portions of a medical device that are shadowed by other surfaces or portions of a medical device. Thus, the spray nozzle includes a collar having an outer surface and an inner surface defining a longitudinal axis of the spray nozzle, a body extending away from the outer surface, the body defining a first portion of a chamber and an outlet from the chamber, and a tube connector extending away from the inner surface along an axis that is perpendicular to the longitudinal axis, the tube connector defining a second portion of the chamber and an inlet to the chamber. The body may be oriented at a polar angle to the perpendicular axis of between about zero degrees and about 60 degrees, e.g., about 35 degrees. The outlet of the spray nozzle may comprise a notch, such as a V-notch. The notch may be also oriented at various angles. As such the notch may assist in creating various spray patterns of a liquid that may be ejected through the spray nozzle.

[0005] The spray nozzle assembly may include a first tube defining a rotational axis of the spray nozzle assembly. The spray nozzle may also include a second tube coupled to the first tube that comprises a circumferential surface and holes disposed through the circumferential surface. Multiple spray nozzles may be mated to the second tube such that the second tube connectors of these spray nozzles are disposed through the holes and the inlets are disposed in the second tube. These spray nozzles may be mated to the second tube such that they point away from the rotational axis, toward the rotational axis, or some combination thereof. The spray nozzle assembly may also include plugs to cover any holes in the second tube that are not mated to a spray nozzle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0007] Figure 1 depicts a front elevational view of an exemplary decontamination system;

[0008] Figure 2 depicts a schematic diagram of the decontamination system of Figure 1 , with only a single basin shown for clarity;

[0009] Figure 3 depicts a perspective view of an endoscope in a basin of the decontamination system of Figure 1 ;

[0010] Figure 4 depicts a perspective view of a spray nozzle of a spray nozzle assembly of the decontamination system of Figure 1 ;

[0011] Figure 5 depicts a front view of the spray nozzle of Figure 4;

[0012] Figure 6 depicts a rear view of the spray nozzle of Figure 4;

[0013] Figure 7 depicts a bottom view of the spray nozzle of Figure 4;

[0014] Figure 8 depicts a section view of the spray nozzle of Figure 4 taken along the line

8-8 in Figure 6;

[0015] Figure 9 depicts an exemplary spray nozzle assembly of the decontamination system of Figure 1, and a spray pattern produced by the spray nozzle assembly; and [0016] Figure 10 depicts the spray nozzle assembly of Figure 9, but without any spray nozzles attached thereto.

MODES OF CARRYING OUT THE INVENTION

[0017] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0018] As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to the range of values ±10% of the recited value, e.g. "about 90%" may refer to the range of values from 81% to 99%. In addition, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.

[0019] FIGS. 1-2 show an exemplary decontamination or reprocessing system 2 that may be used to decontaminate (e.g., sterilize or disinfect) endoscopes and other medical devices that include channels or lumens formed therethrough. System 2 of this example generally includes a first station 10 and a second station 12. Stations 10, 12 are at least substantially similar in all respects to provide for the decontamination of two different medical devices simultaneously or in series. First and second decontamination basins 14a, 14b receive the contaminated devices. Each basin 14a, 14b is selectively sealed by a respective lid 16a, 16b. In the present example, lids 16a, 16b cooperate with respective basins 14a, 14b to provide a microbe-blocking relationship to prevent the entrance of environmental microbes into basins 14a, 14b during decontamination operations. By way of example only, lids 16a, 16b may include a microbe removal or HEPA air filter formed therein for venting.

[0020] A control system 20 includes one or more microcontrollers, such as a programmable logic controller (PLC), for controlling decontamination and user interface operations. Although one control system 20 is shown herein as controlling both decontamination stations 10, 12, each station 10, 12 may include a dedicated control system. A visual display 22 displays decontamination parameters and machine conditions for an operator, and at least one printer 24 prints a hard copy output of the decontamination parameters for a record to be filed or attached to the decontaminated device or its storage packaging. It should be understood that printer 24 is merely optional. In some versions, visual display 22 is combined with a touch screen input device. In addition, or in the alternative, a keypad and/or other user input feature is provided for input of decontamination process parameters and for machine control. Other visual gauges 26 such as pressure meters and the like provide digital or analog output of decontamination or medical device leak testing data.

[0021] Figure 2 diagrammatically illustrates just one decontamination station 10 of decontamination system 2, but those skilled in the art will recognize that decontamination station 12 may be configured and operable just like decontamination station 10. It should also be understood that decontamination system 2 may be provided with just one single decontamination station 10, 12 or more than two decontamination stations 10, 12.

[0022] Decontamination basin 14a receives an endoscope 200 (see Figure 3) or other medical device therein for decontamination. Any internal channels of endoscope 200 are connected with flush conduits, such as flush lines 30. Each flush line 30 is connected to an outlet of a corresponding pump 32, such that each flush line 30 has a dedicated pump 32 in this example. Pumps 32 of the present example comprise peristaltic pumps that pump fluid, such as liquid and air, through the flush lines 30 and any internal channels of endoscope 200. Alternatively, any other suitable kind of pump(s) may be used. In the present example, pumps 32 can either draw liquid from basin 14a through a filtered drain and a valve SI; or draw decontaminated air from an air supply system 36 through a valve S2. Air supply system 36 of the present example includes a pump 38 and a microbe removal air filter 40 that filters microbes from an incoming air stream. [0023] A pressure switch or sensor 42 is in fluid communication with each flush line 30 for sensing excessive pressure in the flush line. Any excessive pressure or lack of flow sensed may be indicative of a partial or complete blockage (e.g., by bodily tissue or dried bodily fluids) in an endoscope 200 channel to which the relevant flush line 30 is connected. The isolation of each flush line 30 relative to the other flush lines 30 allows the particular blocked channel to be easily identified and isolated, depending upon which sensor 42 senses excessive pressure or lack of flow. [0024] Basin 14a is in fluid communication with a water source 50, such as a utility or tap water connection including hot and cold inlets, and a mixing valve 52 flowing into a break tank 56. A microbe removal filter 54, such as a 0.2 pm or smaller absolute pore size filter, decontaminates the incoming water, which is delivered into break tank 56 through the air gap to prevent backflow. A sensor 59 monitors liquid levels within basin 14a. An optional water heater 53 can be provided if an appropriate source of hot water is not available. The condition of filter 54 can be monitored by directly monitoring the flow rate of water therethrough or indirectly by monitoring the basin fill time using a float switch or the like. When the flow rate drops below a select threshold, this indicates a partially clogged filter element that requires replacement.

[0025] A basin drain 62 drains liquid from basin 14a through an enlarged helical tube 64 into which elongated portions of endoscope 200 can be inserted. Drain 62 is in fluid communication with a recirculation pump 70 and a drain pump 72. Recirculation pump 70 recirculates liquid from basin drain 62 to a spray nozzle assembly 60, described below, which sprays the liquid into basin 14a and onto endoscope 200. A coarse screen 71 and a fine screen 73 filter out particles in the recirculating fluid. Drain pump 72 pumps liquid from basin drain 62 to a utility drain 74. A level sensor 76 monitors the flow of liquid from pump 72 to utility drain 74. Pumps 70, 72 can be simultaneously operated such that liquid is sprayed into basin 14a while basin 14a is being drained, to encourage the flow of residue out of basin 14a and off of endoscope 200. Of course, a single pump and a valve assembly could replace dual pumps 70, 72.

[0026] An inline heater 80 with temperature sensors 82, upstream of recirculation pump

70, heats the liquid to optimum temperatures for cleaning and/or disinfection. A pressure switch or sensor 84 measures pressure downstream of circulation pump 70. In some variations, a flow sensor is used instead of pressure sensor 84, to measure fluid flow downstream of circulation pump 70. Detergent solution 86 is metered into the flow downstream of circulation pump 70 via a metering pump 88. A float switch 90 indicates the level of detergent 86 available. Decontaminant 92 is metered into the flow upstream of circulation pump 70 via a metering pump 94. To more accurately meter decontaminant 92, pump 94 fills a metering pre-chamber 96 under control of a fluid level switch 98 and control system 20. By way of example only, decontaminant solution 92 may comprise an activated glutaraldehyde salutation, such as CIDEX® Activated Glutaraldehyde Solution by Advanced Sterilization Products of Irvine, California. By way of further example only, decontaminant solution 92 may comprise ortho-phthalaldehyde (OPA), such as CIDEX® ortho- phthalaldeyde solution by Advanced Sterilization Products of Irvine, California. By way of further example only, decontaminant solution 92 may comprise peracetic acid (PAA). [0027] Some endoscopes 200 include a flexible outer housing or sheath surrounding the individual tubular members and the like that form the interior channels and other parts of endoscope 200. This housing defines a closed interior space, which is isolated from patient tissues and fluids during medical procedures. It may be important that the sheath be maintained intact, without cuts or other holes that would allow contamination of the interior space beneath the sheath. Therefore, decontamination system 2 of the present example may optionally include means for testing the integrity of such a sheath. In particular, an air pump (e.g., pump 38 or another pump 110) pressurizes the interior space defined by the sheath of endoscope 200 through a conduit 112 and a valve S5. In the present example, a HEPA or other microbe -removing filter 113 removes microbes from the pressurizing air. A pressure regulator 114 prevents accidental over pressurization of the sheath. Upon full pressurization, valve S5 is closed and a pressure sensor 116 looks for a drop in pressure in conduit 112, which would indicate the escape of air through the sheath of endoscope 200. A valve S6 selectively vents conduit 112 and the sheath of endoscope 200 through an optional filter 118 when the testing procedure is complete. An air buffer 120 smoothes out pulsation of pressure from air pump 110.

[0028] In the present example, each station 10, 12 also contains a drip basin 130 and spill sensor 132 to alert the operator to potential leaks.

[0029] An alcohol supply 134, controlled by a valve S3, can supply alcohol to channel pumps 32 after rinsing steps, to assist in removing water from channels 210, 212, 213, 214, 217, 218 of endoscope 200.

[0030] Flow rates in lines 30 can be monitored via channel pumps 32 and pressure sensors

42. If one of pressure sensors 42 detects too high a pressure, the associated pump 32 is deactivated. The flow rate of pump 32 and its activated duration time provide a reasonable indication of the flow rate in an associated line 30. These flow rates are monitored during the process to check for blockages in any of the channels of endoscope 200. Alternatively, the decay in the pressure from the time pump 32 cycles off can also be used to estimate the flow rate, with faster decay rates being associated with higher flow rates.

[0031] A more accurate measurement of flow rate in an individual channel may be desirable to detect subtler blockages. To that end, a metering tube 136 having a plurality of level indicating sensors 138 fluidly connects to the inputs of channel pumps 32. In some versions, a reference connection is provided at a low point in metering tube 136 and a plurality of sensors 138 are arranged vertically above the reference connection. By passing a current from the reference point through the fluid to sensors 138, it can be determined which sensors 138 are immersed and therefore determine the level within metering tube 136. In addition, or in the alternative, any other suitable components and techniques may be used to sense fluid levels. By shutting valve SI and opening a vent valve S7, channel pumps 32 draw exclusively from metering tube 136. The amount of fluid being drawn can be very accurately determined based upon sensors 138. By running each channel pump 32 in isolation, the flow therethrough can be accurately determined based upon the time and the volume of fluid emptied from metering tube 136.

[0032] In addition to the input and output devices described above, all of the electrical and electromechanical devices shown are operatively connected to and controlled by control system 20. Specifically, and without limitation, switches and sensors 42, 59, 76, 84, 90, 98, 114, 116, 132 136 provide input (I) to microcontroller 28, which controls the cleaning and/or disinfection cycles and other machine operations in accordance therewith. For example, microcontroller 28 includes outputs (O) that are operatively connected to pumps 32, 38, 70, 72, 88, 94, 100, 110, valves SI, S2, S3, S5, S6, S7, and heater 80 to control these devices for effective cleaning and/or disinfection cycles and other operations.

[0033] Figure 3 shows endoscope 200 disposed in basin 14a in a coiled configuration. As such, one portion of the endoscope’s tubing overlaps or “shadows” another portion of the endoscope’s tubing. The surfaces that shadow each other present a challenge to the cleaning and disinfection of the endoscope by decontamination system 2 because the cleaning and disinfection solutions cannot readily impinge, contact, or flow over the surfaces that are overlapped by other surfaces.

[0034] Figures 4-8 reflect a spray nozzle 300 that may be implemented into decontamination system 2, specifically on spray nozzle assembly 60 as seen in Figures 2, 9, and 10. Spray nozzle 300 improves on current designs of spray assemblies in decontamination systems by: 1) providing lateral sprays of cleaning and disinfection solutions; 2) simplifying modifications to spray nozzle assembly 60 by enabling modularity thereof; and 3) allowing for optimization of spray patterns, e.g., based on the length of the endoscope in the basin and the amount of shadowing present.

[0035] Spray nozzle 300 includes a collar 302 having an outer surface 304 and an inner surface 306. Collar 302 defines a longitudinal axis 308 of the spray nozzle. Spray nozzle 300 also includes a body 310 extending away from outer surface 304. Body 310 defines a first portion 314 of a chamber 312 and an outlet 316 from the chamber. Body 310 may include a top or notch surface 325 that includes a notch 326 for outlet 316. The shape of notch 326 which contributes the resulting pattern of a liquid sprayed through outlet 316. For example, and as shown, notch 326 may be a V- notch. Notch surface 325 may be circular, although not a complete circle due to the presence of the notch therethrough. [0036] Spray nozzle 300 also includes a tube connector 318 extending away from inner surface 306 along an axis 320 that is perpendicular to the longitudinal axis. Tube connector 316 defines a second portion 322 of chamber 312 and an inlet 324 to the chamber.

[0037] In terms of spherical coordinates, body 310 may be oriented at a polar angle 0 relative to perpendicular axis 320, as seen in Figure 8. The polar angle 0 may range from between about zero degrees (i.e., axis 320 is coaxial with a longitudinal axis of body 310) and about 60 degrees, e.g., about thirty-five degrees. In the embodiment shown, the azimuthal angle of body 310 (relative to longitudinal axis 308 is zero, however, in further embodiments, the azimuthal angle may be greater than zero. As best seen in Figure 5, notch 326 may be oriented transversely to a centerline 364 of notch surface 325 that intersects perpendicular axis 320 and the longitudinal axis 305. As such, centerline 364 and axis 320 appear collinear in Figure 5. Put in terms of the X- Y-Z coordinate axes reflected on Figure 5, a projection of notch 326 onto the Y-Z plane is asymmetric about the Z-axis. The notch need not be oriented transversely, however. Instead, it may be oriented parallel to the centerline of the notch surface that intersects perpendicular axis 320 and the longitudinal axis 305, such that a projection of notch 326 onto the Y-Z plane would be symmetric.

[0038] Spray nozzle 300 may be fabricated by any suitable method, including but not limited to injection molding, machining, and 3-D printing. There are multiple considerations for the material selection, such as chemical compatibility with decontaminant solutions, including sterilants such as peracetic acid. Other considerations include, e.g., thermal compatibility and cost. Thus, spray nozzle 300 may be fabricated from materials such as PPSU, PEEK, and PVDF. [0039] With reference to Figures 9 and 10, spray nozzle assembly 60 may include a first tube 350 defining a rotational axis 352 of spray nozzle assembly 60, and a second tube 354 coupled transversely or perpendicularly to first tube 350, e.g., at a midpoint of second tube 354 or offset therefrom. For example, the coupling may be achieved using a standard post and hub design, in which case first tube 350 may be considered the post and second tube 354 would comprise two halves, each of which would be coupled to first tube 350 by the post. Second tube 354 may comprise a circumferential surface 358 and at least one hole 356, disposed through the circumferential surface as seen in Figure 10. A spray nozzle 300 may be coupled to second tube 354 by disposing tube connector 318 into one of the holes 356 and fitting collar 302 about second tube 354 such that inner surface 306 is in close or tight conformity with circumferential surface 358. In further embodiments, plugs 360 may be provided and coupled to holes 356 of second tube 354 in a similar fashion to the spray nozzles. Plugs 360 are similar in structure to nozzles 300, particularly with respect to tube connector 318, but are solid or otherwise configured to plug holes 356. As seen in Figure 9, eight spray nozzles 300 and eight plugs 360 are provided. Plugs 360 may assist in modifying desired spray patterns generated by assembly 60, discussed further below [0040] In preferred embodiments, between four and sixteen, e.g., ten, spray nozzles 300 are provided. As seen in Figure 9, the eight spray nozzles 300 may face in one of two directions, i.e., either toward the rotational axis or away from the rotational axis. So, for example, the notch surface of a first spray nozzle 300a may face away from the rotational axis, the notch surface of a second spray nozzle 300b may face away from the rotational axis, the notch surface of a third spray nozzle may face toward rotational axis, or some combination thereof. At least two spray nozzles may be disposed two one side of the rotational axis (e.g., nozzles 300b and 300c), or they may be disposed on opposite sides of the rotational axis (e.g., nozzles 300a and 300b. Plugs 360 may be similarly disposed relative to the rotational axis. [0041] Nozzles 300 included on second arm 354 (e.g., 300a-c) may have different polar angles than at least one other spray nozzle 300. For example, the polar angle 0 of spray nozzle 300a may be greater than the polar angle 0 of the spray nozzle 300b. Furthermore, notches 326 of these nozzles may have varying orientations relative to the others. For example, notch 326 of nozzle 300a may be oriented more transversely relative to centerline 364 of notch surface 325 than notch 326 of second spray nozzle 300b is oriented relative to its centerline 364. Furthermore, at least two of the spray nozzles 300 may be identical to each other. By varying any one to all of the design characteristics of the location of first tube 350 relative to second tube 354 (i.e., centered or offset), the locations of nozzles 300 on second arm 354, the polar angles of bodies 310, the shape of notches 326, and the orientations of the notches 326, many different spray patterns can be implemented. Preferably, the spray from one nozzle 300 does not interfere with the spray from another nozzle 300. Varying the foregoing design characteristics, particularly the orientation of notch 326, may assist in creating non-interfering sprays. Moreover, by varying these design characteristics, cleaning and disinfectant solutions may be directed to shadowed surfaces of endoscope 200 with varying angles of attack and impingement forces, particularly as second tube 354 spins about axis 352. Such may further improve cleaning and disinfecting of shadowed surfaces. Additionally, these design characteristics may be optimized to certain instruments to address the challenges they provide to cleaning and disinfection caused by their shadowing. [0042] Based on the foregoing, decontamination system 2 includes at least one spray nozzle assembly 60 in any of the embodiments or variations described above. Where two spray nozzle assemblies are provided, one may be disposed in the top and the other in the bottom of basin 14, such that an instrument may be disposed between the two spray nozzle assemblies, e.g., on a platform. [0043] Decontamination system 2 may thus be used to conduct the following method. First, an instrument, e.g., a soiled medical instrument, may be disposed in the basin of the reprocessing system. In the case of certain instruments, particularly long flexible instruments like endoscopes, this step may further include placing a first surface of the instrument against a second surface of the instrument. Such results in creation of a shadowed surface. Second a decontamination liquid (e.g., water, detergent solution, disinfection solution) may be ejected through at least one of the spray nozzles. Where a shadowed surface is present, the step of ejecting the decontamination liquid results in the decontamination liquid penetrating between the first surface and the second surface of the instrument.

[0044] Any of the examples or embodiments described herein may include various other features in addition to or in lieu of those described above. The teachings, expressions, embodiments, examples, etc., described herein should not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined should be clear to those skilled in the art in view of the teachings herein.

[0045] Having shown and described exemplary embodiments of the subject matter contained herein, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications without departing from the scope of the claims. In addition, where methods and steps described above indicate certain events occurring in certain order, it is intended that certain steps do not have to be performed in the order described but in any order as long as the steps allow the embodiments to function for their intended purposes. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Some such modifications should be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative. Accordingly, the claims should not be limited to the specific details of structure and operation set forth in the written description and drawings.