巴西专利BR112016011984B1 COMBINED STERILIZATION INDICATOR READER AND INCUBATOR SYSTEM AND METHODS FOR DETERMINING THE EFFECTI

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专利摘要:
combined sterilization indicator reader and incubator system and methods of determining the effectiveness of a sterilization process. The present invention relates to a combined sterilization indicator reader and incubator system, including a sterilization indicator bottle containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each independently operable incubator block for incubating the sterilization indicator flask at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of a plurality of independently selectable temperatures; a light source, a photo detector and a control system configured to operate the combined system to determine the effectiveness of a variety of sterilization processes. the system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on comparing the calculated slope to the predetermined threshold slope without first determining a baseline or minimum value. output of the photo detector.
公开号:BR112016011984B1
申请号:R112016011984-3
申请日:2014-09-10
公开日:2021-08-03
发明作者:Phillip P. Franciskovich；Tricia A. Cregger；Paul VODKIN
申请人:American Sterilizer Company；
IPC主号:

专利说明:

Field of Invention
[001] The present invention relates to an apparatus and method for determining the effectiveness of a sterilization process. More specifically, the present invention provides a combined sterilization indicator reader and incubator system, in which a sterilization indicator vial can be exposed to sterilization conditions and subsequently activated and incubated and based on emanating light analysis from the bottle, the effectiveness of the sterilization process determined. Background of the Invention
[002] Several systems for determining the effectiveness of sterilization processes are known in the state of the art. There are several types of indicators used in the field, each providing varying levels of assurance to the user that the appropriate processing requirements have been met.
[003] One of the most important classes of indicators are biological indicators (BI). Bis provide the highest degree of assurance that sterilization conditions have been met within the processor or processed load itself. This type of indicator is designed to represent the worst case for the processing system, providing an extremely high number of organisms highly resistant to that particular process in or on the indicator. Spores are typically the organism of choice for monitoring sterilization systems.
[004] Biological indicators include microorganisms inoculated on a carrier material. Microorganisms are typically bacterial spores that are known to be very resistant to the particular sterilization medium in which they are to be used. The carrier is placed on a sterilization cycle along with the medical device charge. Upon completion of the cycle the bacterial spores within the biological indicator are incubated and monitored for growth over periods of up to seven days. The growth of bacterial spores on the biological indicator indicates that the sterilization process was not effective. No growth of the biological indicator confirms that conditions within the sterilizer were adequate to kill at least the number of bacterial spores on the indicator (eg 106 bacterial spores) and therefore provides a level of assurance that the medical device charge it is sterile.
[005] Due to many factors, there is a need in the hospital environment to determine the effectiveness of sterilization as quickly as possible. Prior art systems required 12 to 48 hours for this determination. More recently, fluorescence has been used to detect the activity of enzymes that are produced by test organisms by adding a fluorogenic enzyme substrate to the culture medium. This methodology cuts the incubation time from days to hours. However, the main limitation for reducing the incubation time beyond what is observed for this methodology is the requirement for pre-incubation and subsequent monitoring of the fluorescence of the biological indicator. These indicators are primarily designed with the aim of containing the biological indicator cells in a manner and manner consistent with the requirements for placement in the sterilizer under evaluation and not necessarily for ease of use in subsequent fluorescence detection steps.
[006] Such a product that allows the rapid assessment of a biological indicator exists, which combines incubation with the simultaneous monitoring of fluorescent emissions and requires the determination of a baseline level of emissions. This product minimally includes a single heating block, which is adjusted to a selected temperature, and a number of vertical holes in each of which a biological indicator can be placed. The heater block has horizontal through holes that line up with transmission panels on a biological sample container at the sample location so that UV light from the UV emitting lamps can be passed through the biological sample. On a separate movable printed circuit board resides a single detector which must be moved into alignment with each of the through holes so that the detector passes in front of each sample location in turn. Detector movement is under the control of an on-board processor and requires moving parts. The detector is moved from such a sample location with through hole to the next in a sequence and readings are taken for each sample present. An algorithm programmed into the logic controller is used to first determine a baseline level of fluorescence and then to detect the presence of fluorescence at a level above the baseline level. Based on the baseline and the reading obtained, an interpretation is made of a PASS (negative) or FAIL (positive) nature to advise the user if the conditions have been met in the sterilization cycle to be evaluated by the biological indicator.
[007] Document US 2013/0217107 discloses an incubator/reader system in which, among other things, the light source is always situated adjacent to, beside and not under the sterilization indicator bottle, and always projects light through a side panel, not a bottom panel, of the sterilization indicator bottle.
[008] Document US 2013/0217040 discloses a light source positioned under the bottle, and this allows light to project along the entire length of an indicator element, see paragraph [0052].
[009] The document US 6664113 discloses a fluorescence detection system configured to radiate excitation light from below and capture a fluorescent signal in the horizontal direction. US 4318618 discloses a method for automatically measuring absorbance, which comprises analyzing only changing values without requiring a zero setting and a 100% setting, in order to process the absorbance measurement of the sample in the cell in short time.
[0010] In the prior art cited above, the dependence on moving parts introduces the potential for mechanical failures and/or optical path misalignments. The movement of parts can generate or be interfered with kinetic forces (vibration and mechanical shock) and can create wear on surfaces that need maintenance and/or periodic recalibration. The presence of a single heating block means that only one temperature can be used by each machine at any given time or may require the purchase of a separate machine for use at different temperatures.
[0011] What is needed is a design that eliminates moving parts, wear points and other mechanical aspects that can impact the durability and performance of such a reader incubator, which eliminates variations in the alignment of the light source, the biological indicator and the detector, which does not require the determination of a baseline or minimum fluorescence level before starting to read test results, while at the same time providing an early and reliable indication of the effectiveness of the sterilization process. Brief Description of the Invention
[0012] The present invention provides a solution to the aforementioned problems of the prior art while, at the same time, the present invention provides a system that enjoys a prior indication of the effectiveness of the sterilization process, and maintains a high degree of reliability and provides simple, yet very flexible, use of biological indicators in sterilization processes.
[0013] Thus, in one embodiment, the present invention provides a combined sterilization indicator reader and incubator system, including: - a sterilization indicator bottle containing a selected biological indicator and a liquid, wherein the sterilization indicator bottle comprises a building material, a bottom panel, an inner cavity and an outer side surface, both the building material and the outer side surface adapted to transmit light emanating from the inner cavity, the bottom panel adapted to transmit the directed light over the bottom panel into the interior cavity; - at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator flask at a plurality of independently selectable temperatures, each incubator block comprising: (a) at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; (b) at least one cavity, each cavity associated with a heating element, and each cavity sized to receive and hold the sterilization indicator bottle; (c) a light source positioned relative to each cavity to direct the light source through the bottom panel into the interior cavity of the sterilization indicator bottle when the sterilization indicator bottle is in the cavity; (d) a photodetector positioned to detect the exit light emanating from the interior cavity, the photodetector positioned at an angle to a direction from which the light source is directed through the bottom panel of the sterilization indicator bottle ; (e) a user interface operatively communicating with a control system, the control system including operable hardware to: - separately control each heating element to operate at a selected among selectable temperatures, - operate the light source, - operate the photodetector, - operate the user interface, the user interface operatively communicating with the control system to operate the combined sterilization indicator reader and incubator system, and - calculate and output data for the user interface in regarding the effectiveness of a sterilization process based on the output of the photodetector during the incubation of the sterilization indicator vial.
[0014] In one embodiment, the sterilization indicator vial further comprises at least one radially outwardly extending support member disposed along at least a portion of the outer side surface.
[0015] In one embodiment, each cavity comprises a number of slots extending radially outward from the cavity, wherein the number and position of the slots correspond to the number and position of the at least one support member, and in that each cavity is adapted to operatively receive the sterilization bottle in a number of orientations corresponding to the number of slots.
[0016] In one embodiment, the sterilization indicator bottle is adapted to provide output light transmission emanating from the interior of the sterilization indicator bottle without regard to its rotational orientation in the cavity, provided that the support members are aligned with and received in the cracks.
[0017] In one embodiment, the angle at which the photodetector is positioned is in the range of about 22° to about 158° with respect to the direction from which the light source is directed through the bottom panel of the indicator vial of sterilization.
[0018] In one embodiment, the light source is an excitation light source of the selected wavelength output range.
[0019] In one embodiment, the photodetector is adapted to detect output light of the selected output range of wavelength emanating from the interior of the sterilization indicator bottle.
[0020] In one embodiment, the output light comprises both one or more of photoluminescence, phosphorescence or fluorescence and a light source portion.
[0021] In one embodiment, the plurality of selectable temperatures are in the range of about 20°C to about 70°C.
[0022] In one embodiment, the control system is adapted to operate the user interface to provide user selection of selectable temperature for incubation of a sterilization indicator vial placed within the well, and to provide indication of any change in the output light detected by the photodetector when the sterilization indicator bottle is placed in the well and incubated.
[0023] In one embodiment, each cavity is adapted to provide contact with at least a substantial portion of the outer side surface of the sterilization indicator bottle.
[0024] In one embodiment, the photodetector is positioned to detect when the sterilization indicator vial (a) has been activated, (b) is correctly positioned in the cavity, and/or (c) contains a predetermined fluid level, based on on the exit light.
[0025] In one embodiment, the system is adapted to provide a signal on the user interface to indicate if any one or more of (a), (b) or (c) is not satisfied.
[0026] In one embodiment, the control system includes hardware configured to, during incubation, periodically sample output readings from the photodetector and to calculate a slope of a line obtained from a plurality of sampled output readings, to compare the calculated slope to a predetermined threshold slope for a specific sterilization indicator contained in the sterilization bottle, and to provide output data related to the effectiveness of the sterilization process based on the comparison.
[0027] In one embodiment, the control system is configured to provide output data based only on the comparison of the calculated slope to the predetermined threshold slope without first determining a baseline or minimum value of the photodetector output .
[0028] In one embodiment, the system further comprises a separate lid for each incubator block, in which the lid and the incubator block are configured so that the lid can be closed only when each cavity is occupied or not occupied by an indicator bottle properly placed and activated sterilization device.
[0029] In one embodiment, the present invention relates to a method of determining the effectiveness of a sterilization process, including providing the combined sterilization indicator reader and incubator system described above; expose the sterilization indicator bottle to a sterilization process under conditions designed to sterilize the biological indicator; and operating the system to determine if the sterilization process was effective.
[0030] In one embodiment, the present invention relates to a method of determining the effectiveness of a sterilization process, including: - providing the combined sterilization indicator reader and incubator system as described above and operating the associated heating element to one selected from the at least one cavity to one of the plurality of selectable temperatures; - expose the sterilization indicator bottle to a sterilization process under conditions designed to sterilize a specific type of biological indicator contained in the sterilization indicator bottle; - activate the exposed sterilization indicator bottle and insert the activated sterilization indicator bottle into the selected cavity; - confirm that the activated sterilization indicator vial has been activated, is correctly positioned in the selected cavity and contains a predetermined fluid level, directing the light through the bottom panel into the interior cavity of the sterilization indicator vial, detect the light output emerging from the interior cavity with the photodetector, and providing confirmation or lack thereof to the control system; - after confirmation, incubate the biological indicator in the activated sterilization indicator bottle; - during incubation, directing a light source through the bottom panel into the interior cavity, and operating the photoelectric cell to detect the exit light emanating from the interior cavity; and - operate the control system to calculate and produce data for the control system based on the output from the photodetector during incubation to determine whether the sterilization process was effective, and provide a user interface signal indicative of effectiveness or from the lack of it.
[0031] In one embodiment, the operation of the control system comprises periodically sampling output readings from the photodetector during incubation, calculating a slope of a line obtained from a plurality of sampled output readings, comparing the calculated slope to a predetermined threshold slope for the specific type of biological indicator contained in the sterilization bottle, and provide a user interface signal based on the comparison.
[0032] In one embodiment, the data relating to the effectiveness of the sterilization process is based only on comparing the calculated slope to the predetermined threshold slope and the calculated slope is determined without first determining a baseline or minimum value of the photodetector output.
[0033] In one embodiment, the sterilization process is considered to have failed when the calculated slope equals or exceeds the predetermined threshold slope.
[0034] In one embodiment, two of the sterilization indicator bottles are simultaneously incubated at two different temperatures separate from the incubator blocks.
[0035] In one embodiment, the output light detected by the photodetector comprises one or more of photoluminescence, phosphorescence and fluorescence.
[0036] Thus, the present invention provides a solution to the aforementioned problems of the prior art, as described in detail below. As will be understood, the present disclosure provides an exemplary description of the present invention, which is limited only by the scope of the appended claims. Brief Description of Drawings
[0037] The present invention can be useful with a variety of biological indicators used in sterilization indicators. The accompanying drawings are intended to provide an exemplary and non-limiting description of a suitable sterilization apparatus and to demonstrate the disclosed process, for the purpose of providing a better understanding of the present invention, and are not intended to be limited in any way. In the accompanying drawings, similar parts and features may have similar reference numerals.
[0038] Figure 1 is a schematic representation of a combined sterilization indicator reader and incubator system according to an embodiment of the present invention.
[0039] Figure 2 is a schematic flowchart illustrating a process according to an embodiment of the present invention.
[0040] Figures 3A and 3B are a side elevation view and a bottom plan view of a sterilization indicator bottle suitable for use with embodiments of the present invention.
[0041] Figures 4A, 4B, 4C and 4D are schematic representations of parts of an incubator block according to an embodiment of the present invention.
[0042] Figures 5A, 5B and 5C are schematic representations of parts of a heater chassis together with operating components of an incubator block for a system according to an embodiment of the present invention.
[0043] Figure 6 is a drawing representing a commercial embodiment of the present invention.
[0044] Figures 7A, 7B, 7C and 7D include examples of various indications that may be displayed on the user interface screen of Figure 6.
[0045] Figure 8 is a graph showing how the results of incubation and reading according to one embodiment of the present invention are analyzed to determine whether the sterilization process under evaluation is effective.
[0046] It should be appreciated that, for simplicity and clarity of illustration, the elements shown in the figures were not necessarily drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to each other for clarity. In addition, where appropriate, reference numbers have been repeated between the figures to indicate corresponding elements.
[0047] In addition, it should be appreciated that the structures and process steps described herein may not form a complete process flow for producing an end-use combined sterilization indicator reader and incubator system. The present invention can be practiced in conjunction with processing apparatus and techniques currently used in the prior art, and only so many of the commonly practiced process steps are included as are necessary for an understanding of the present invention. Detailed Description of the Invention
[0048] The present invention provides a solution to the problems of the state of the art, and provides a system that allows an early indication of the effectiveness, or lack thereof, of the sterilization process. The present invention further provides a high level of reliability and ease of use for biological indicators in determining the effectiveness of sterilization processes.
[0049] As used herein, the term "activate", "activated" and cognate terms, when used in connection with a sterilization indicator bottle containing a biological indicator and a liquid containing a growth medium, means that the biological indicator was combined with the liquid containing the growth medium so that any microorganisms in the biological indicator that survived a sterilization process can be incubated.
[0050] As used herein, the term "incubate", "incubated" and cognate terms, when used in connection with a sterilization indicator bottle containing a biological indicator and a liquid containing a growth medium, means that the biological indicator has been activated and exposed to appropriate conditions, for example, temperature, humidity and atmosphere, where any microorganisms in the biological indicator that have survived a sterilization process can begin to metabolize and grow, so that the indicator vial indicator function of Sterilization can be used to assess the effectiveness of a sterilization process to which the sterilization indicator bottle has been exposed.
[0051] Figure 1 is a simplified schematic representation of a combined sterilization indicator reader and incubator system (100) according to an embodiment of the present invention. As shown in Figure 1, in accordance with the present invention, the system (100) includes two or more incubator blocks 1, 2, 3...n, each incubator block separately and independently controlled by a control system (102) which , in turn, provides reading and other information to a user interface (104). For simplicity, incubator blocks 2, 3...n are not shown separately, but each of these incubator blocks would be substantially identical to the incubator block (1) shown in Figure 1.
[0052] As depicted in Figure 1, the incubator block (1) includes a heater chassis (106). The heater chassis (106) includes a cavity (108) into which an activated sterilization indicator bottle (110) fits. In one embodiment, the vial (110) fits within the cavity (108) so that a substantial portion of the outer sides of the vial (110) is in contact with the walls of the cavity (108) so as to provide maximum transfer of heat to the flask (110) and its contents, ie a biological indicator and its appropriate incubation medium (112).
[0053] The heater chassis (106) is heated by at least one heating element (114). The heating element (114) is controlled via electrical connections to the control system (102), based on feedback provided to the control system (102) by at least one temperature sensor (116). The temperature sensor (116), in a known way, detects the temperature of the heater chassis (106), provides this temperature information to the control system (102) which, in turn, determines the time and intensity of heat applied to the heater chassis (106) by the heating element (114). The control system (102) provides information to the user interface (104) about the actual and adjusted points for the temperature of each incubator block and, based on user input via the user interface (104), the control system (102) controls the temperature of the heater chassis (106). The at least one temperature sensor (116) provides temperature information or data to the control system (102).
[0054] In accordance with the present invention, each incubator block is adapted to provide heat to incubate one or more vials (110) at a preselected temperature, independently of the other incubator blocks. Thus, for example, incubator block (1) can be operated at 37°C, while incubator block (2) can be operated simultaneously at 57°C, or incubator block (1) can be operated at 57°C , while the incubator block (2) can be operated simultaneously at 37°C. Both blocks can be operated at the same or at different temperatures, and additional incubator blocks can be operated at other temperatures. Note that temperatures of 37°C and 57°C are merely exemplary of current practice, and the possible range of temperatures is not limited to these examples, but can be any temperature at which a given microorganism can be incubated.
[0055] Still referring to Figure 1, each incubator block further includes a light source (118). As schematically depicted in Figure 1, the light source (118), in one embodiment, is positioned in the incubator block below the sterilization indicator bottle (110), so that the light source from the light source (118 ) passes up through the bottom panel (120) of the bottle (110). In Figure 1, the light source is schematically represented by arrows from the light source (118) and the back panel (120). The light source passes through the bottom panel (120) and into the biological indicator and an incubation means (112).
[0056] As depicted in Figure 1, the incubator block additionally includes a photodetector (122). The photodetector (122) is selected to be able to detect output light comprising both light source from the light source (118) and light, such as fluorescence or phosphorescence, emitted by metabolic products of any surviving microorganisms in the biological indicator during incubation. The light source emanating from the interior cavity as output light can be a reflected, scattered or refracted light source. Thus, the output light can comprise both one or more of photoluminescence, phosphorescence or fluorescence and a portion of the light source.
[0057] The photodetector (122) may be a general purpose photodetector capable of detecting light across a wide range of wavelengths, or it may be a more "dedicated" photodetector capable of detecting only light of certain wavelengths. selected. Filters suitable for limiting the wavelength range can be used in any light path. As will be appreciated, there may be advantages to using either of these types of photodetectors. Although the general purpose photodetector provides a wide range of detectable wavelengths, it can lose some sensitivity due to the need to detect many wavelengths of light. On the other hand, while the dedicated photodetector may be more sensitive to certain selected wavelengths, it is not as versatile as the general purpose photodetector. The subject technician can select a suitable photodetector as needed.
[0058] When the vial (110) is initially inserted into the cavity (108), the light source from the light source (118) enters the interior space of the vial (110) in which the biological indicator and an incubation means (112) are located. If the liquid level is high enough, either or both of the native fluorescence or light scattered through the medium (112) can be detected as output light by the photodetector (122), and the photodetector (122) can provide a signal to the system. control (102), whereby the control system (102) determines that the level of liquid in the bottle (110) is adequate. If the sterilization indicator bottle is not properly activated, it will not contain a sufficient liquid level as the incubation liquid will remain in the cap. If the sterilization indicator bottle is not correctly positioned in the cavity, for example, if it is not fully inside the cavity, the light source from the light source will not be scattered, reflected or refracted in the same way as it would if the bottle were correctly placed in the cavity. In one embodiment, the photodetector is positioned to detect when the sterilization indicator vial (a) has been activated, (b) is correctly positioned in the cavity, and/or (c) contains a predetermined fluid level, based on the light of exit. In one embodiment, the system is adapted to provide a signal on the user interface to indicate if any one or more of (a), (b) or (c) is not met. Thus, for example, the control system (102) can provide an indication to the user interface (104) whether the level of liquid within the container (110) is sufficient or not to allow the photodetector (122) to detect the light from output produced by any surviving microorganisms contained in the biological indicator. Similar notifications can be made when the vial is not properly activated and/or when the vial is not correctly positioned in the cavity.
[0059] The light output produced by surviving microorganisms (if any) may include one or more of photoluminescence, phosphorescence and fluorescence. In one embodiment, photodetector (122) is adapted to detect light of individually selected wavelengths. That is, in this embodiment, the photodetector (122) can be selected to detect the output light in one of a variety of different wavelengths, or one or more different wavelength ranges, thus making it useful for many types. different sterilization indicators. The light filters mentioned above can also be used to select the wavelengths to be detected.
[0060] In one embodiment, the photodetector (122) is adapted to detect the output light scattered by the liquid in the vial (110), where the output light is of substantially the same wavelength as the excitation light (source) from the light source (118), wherein the light source has a wavelength in a selected range of wavelengths. The light source may be referred to as excitation light as it may function to excite molecules in the liquid in the flask to thereby produce one or more of photoluminescence, phosphorescence or fluorescence. The wavelength range of the light source can be selected based on the specific microorganism and the reporter gene or reporter protein or other reporter molecule used in the biological indicator used in the specific sterilization indicator bottle (110) used in a sterilization process in private. In current practice, the wavelengths of the light source can be slightly different than the wavelength of the output light that the photodetector detects. The light source wavelength selection is generally open, and may depend on the reporter selected, and may be varied as needed for various embodiments of the present invention. For example, light scattering, reflection, refraction and the like can be used when the emission and excitation wavelengths are the same. Or, in another embodiment, the wavelengths can be varied so that the light emitted by the germinating spore products is of a different wavelength than the excitation wavelength, so that only the emitted light is detected by the photodetector. Furthermore, even though the wavelength of the light source is predominantly in a narrow range, other wavelengths are present over a broader spectrum, such that the predominant wavelengths are used to excite the reporter who subsequently emits a detectable signal, while other neighboring wavelength(s) may be used for other purposes, eg detection, placement and averaging volume.
[0061] Thus, both the excitation wavelength and the wavelengths that the photodetector (122) can detect can be varied as needed to provide the use of a wide variety of biological indicators in the sterilization indicator. The photodetectors described herein are known in the state of the art and can be suitably selected by the person skilled in the art.
[0062] As shown in Figure 1, the photodetector (122) is controlled by and provides data to the control system (102), and this control and data provision may involve and include the user interface (104). Thus, for example, the user interface (104) can include input capability, whereby a system operator can select the appropriate wavelength of light source provided by the light source (118). As another example, the user interface (104) may include reading the intensity and/or wavelength of output light emanating from the interior cavity of the vial (110), and this reading may refer to either or both from a reflected, refracted or scattered light source used to determine the appropriate filling level, the state of activation or positioning of the vial (110) and the light produced by the microorganisms, which light produced by the microorganisms can be one or more of photoluminescence, phosphorescence and fluorescence. In one embodiment, the user interface can include input for selecting the type of microorganism used in the biological indicator, and the system can be programmed to automatically set the photodetector (122) to detect the appropriate wavelength output light and /or to adjust the incubation temperature.
[0063] Although not described in detail, the above description of the incubator block (1) applies independently for the incubator block (2) and any additional incubator blocks that may form part of the general system of embodiments of the present invention.
[0064] According to embodiments of the present invention, the photodetector (122) can be oriented in a range of selected angles towards the direction of the light source from the light source (118). In one embodiment, the photodetector (122) is positioned at an angle in the range of about 22° to about 158° with respect to the direction from which the light source is directed through the bottom panel of the indicator vial. of sterilization (110), in one embodiment, the photodetector (122) is positioned at an angle in the range of about 45° to about 135° with respect to the direction from which the light source is directed through the bottom panel of the vial sterilization indicator (110) and, in another embodiment, the photodetector (122) is positioned at an angle in the range of about 60° to about 120° with respect to the direction from which the light source is directed through the bottom panel of the sterilization indicator bottle (110) and, in one embodiment, the photodetector (122) is positioned at a substantially orthogonal angle, i.e., about 90°, with respect to the direction. from which the light source is directed through the bottom panel of the fras with the sterilization indicator (110).
[0065] In accordance with various embodiments of the present invention, the material of construction of the bottom panel and the side panel of the bottle (110) are selected to allow source and/or output light of selected wavelengths to pass through the panels bottom and side of the bottle (110). As will be understood by the person skilled in the art, the material of construction of the sterilization indicator bottle (110) must be compatible with the sterilant used in the sterilization process, as well as being able to allow light to pass through it. Thus, for example, the material of construction of the sterilization indicator bottle can be one or more of glass, quartz, a polymer (eg, polycarbonate, polypropylene, polyethylene, polystyrene, polyesters, polymethyl methacrylate (PMMA or acrylic), acrylonitrile -butadiene-styrene (ABS), cycloolefin polymers (COP), cycloolefin copolymer (COC), polysulfone (PSU), polyethersulfone (PES), polyetherimide (PEI), polybutylene terephthalate (PBT), terephthalate polyethylene (PET), etc.).
[0066] Figure 2 is a schematic flowchart illustrating a process 200 in accordance with an embodiment of the present invention. As depicted in Figure 2, a process in accordance with the present invention may include the following steps. First, in one step (202), a reader and incubator system is provided with two or more incubator blocks, for example, such as the system (100) described with reference to Figure 1. Then, in one step (204 ), at least one sterilization indicator bottle, for example the bottle (110) from the system (100), is exposed to a sterilization process in a known manner. The sterilization process can be suitably selected by persons skilled in the art.
[0067] After exposing the vial to the sterilization process, as shown in step (206), the exposed sterilization indicator vial(s) is/are activated after the sterilization process. Then, as shown in step (208), each activated vial is placed in an individual well in one of the incubator blocks and reader system.
[0068] After activation and placement of the vial in steps (206) and (208), in one step (210), the system checks to determine and confirm that the sterilization indicator vial is properly activated, positioned and contains a quantity enough of incubator liquid to fill the vial to a minimum fluid level. The minimum fluid level is the level that allows the photodetector to detect exit light emanating from the interior cavity of the vial. As will be understood, if the fluid level is too low, the photodetector will not be able to detect light, and the sterilization indicator will not successfully reflect or report the results of the sterilization process. As shown in Figure 2, if in step (210) it is determined that the vial is not properly activated or positioned in the cavity, steps (206) and/or (208) may be repeated. If the liquid level in the vial is too low, this could be due to improper activation or could be due to, for example, leakage and loss of the incubation liquid inside the container, in which case the sterilization indicator vial would be considered to have failed in its objective to indicate the effectiveness or lack thereof of the sterilization process. As shown in Figure 2, if in step (210) it is determined that the liquid level in the vial is too low, step (206) and/or step (208) may be repeated, or it may be necessary to repeat the sterilization if the liquid has spilled out of the vial or for some other reason there is insufficient liquid in the vial, as shown by the arrow in Figure 2 returning to step (204). This can be avoided, of course, by using a plurality of sterilization indicator bottles in any given sterilization process, thus providing a reserve bottle for the evaluation process.
[0069] After confirming that the sterilization indicator bottle is properly activated, positioned and filled in step (210), in step (212), with the heating element operating at the selected temperature, the biological indicator in the bottle is incubated during a selected period of time at that temperature. The incubation time can be appropriately determined by the skilled person based on the type of biological indicator, but it can be pre-determined based on the type of biological indicator. In accordance with the present invention, in one embodiment, two of the sterilization indicator bottles can be incubated at two different temperatures in separate incubation blocks at the same time. Additional samples can be placed in empty wells at any time without interfering with any samples already placed in the setter blocks.
[0070] During incubation, as shown in step (214), light source from the light source is periodically directed to the bottom of the sterilization indicator bottle, as described above, and photodetector detects any output light produced by or from metabolising microorganisms active in the biological indicator and emanating from the interior cavity of the vial. The photodetector output is routed to the control system.
[0071] As shown in Figure 2, in step 216, the control system calculates and generates data to determine whether the output light emanating from the vial increases during incubation, which would indicate that there are viable microorganisms, and that the sterilization process it cannot kill all the microorganisms, that is, the sterilization process was not effective. Information indicating the effectiveness or lack of effectiveness of the sterilization process is then generated for the user interface. The user interface can provide a signal, such as an audible or visible signal, eg warning light, signal to indicate whether or not the sterilization process was effective.
[0072] According to embodiments of the present invention, the operation of the control system comprises periodically sampling output readings from the photodetector during incubation, calculating a slope of a line obtained from a plurality of sampled output readings, comparing the calculated slope to a predetermined threshold slope for the specific type of biological indicator contained in the sterilization bottle and provide the signal in the user interface based on the comparison. In one embodiment, data relating to the effectiveness of the sterilization process is based only on comparing the calculated slope to the predetermined threshold slope and the calculated slope is determined without first determining a baseline or minimum output value of the photodetector. In one embodiment, the sterilization process is considered to have failed when the calculated slope equals or exceeds the predetermined threshold slope.
[0073] Figures 3A and 3B are a side elevation view and a bottom plan view of a sterilization indicator bottle (300) suitable for use with embodiments of the present invention. The sterilization indicator vial (300) includes a cap (302), one or a plurality of radially outwardly extending support members (306), and a vial body (310).
[0074] Although Figures 3A and 3B show four support members (306), a sterilization indicator bottle in accordance with embodiments of the present invention may have from zero to four such support members (306). As described in more detail below, the support members (306) are designed and intended to fit into wells in the incubator block. In one embodiment, the sterilization indicator vial (300) further includes at least one radially outwardly extending support member (306) disposed along at least a portion of the outer side surface. In one embodiment, each of the at least one well (108) in the incubator block includes at least one well for aligning the sterilization indicator bottle (300) in a position defined by alignment with the at least one support member. In one embodiment, each of the at least one cavity includes a number of slots extending radially outward from the cavity, and the number and position of the slots in the cavity corresponds to the number and position of the member(s) of support (306). In one embodiment, each cavity is adapted to operatively receive the sterilization bottle (300) in a number of orientations corresponding to the number of slots, which corresponds to the number of support members. Thus, if there are four equally distributed support members (306), as shown in Figure 3B, there are four different, but equivalent, orientations in which the vial (300) can be inserted into the cavity. In one embodiment, each cavity is adapted to provide contact with at least a substantial portion of the outer side surface of the sterilization indicator bottle.
[0075] In one embodiment, the sterilization indicator bottle is adapted to provide output light transmission emanating from the interior of the sterilization indicator bottle without regard to its rotational orientation in the cavity, provided the support members are aligned com and received in the slots, if there are support members. Note that while the sterilization indicator bottle (300) includes four support members (306), it is possible that the bottle (300) does not have such support members. In such a case, the bottle can be rotated into any shape in the cavity. Thus, in accordance with the present invention, the sterilization indicator bottle can be placed in the cavity in any rotational orientation, and will work equally well in any such orientation.
[0076] In one embodiment, the sterilization indicator bottle is one described in US Patent 8,173,388 B2, which can be consulted for additional details on this suitable sterilization indicator bottle. US Patent 8,173,388 B2 is hereby incorporated by reference for its teachings relating to the sterilization indicator bottle.
[0077] Figures 4A, 4B, 4C and 4D are schematic representations of certain parts of a heater chassis (400) for an incubator block, in accordance with one embodiment of the present invention. Figures 4A and 4B are perspective views of two halves (402), (404) of a heater chassis for use in an incubator block (400) in accordance with one embodiment of the present invention. Figure 4C is a bottom plan view of one of the parts (402) or (404). Figure 4D is a top plan view of the two halves (402), (404), in the position they would occupy in an assembled heater chassis (400).
[0078] In the embodiment illustrated in Figures 4A and 4B, the parts (402), (404) are actually mirror images of one another; that is, each "half" (eg (402)) of the heater chassis is identical to the other half (eg (404)). In this embodiment, parts (402) and (404) can be made from castings, thus simplifying the fabrication of the heater chassis (400). As will be recognized, the heater chassis can be fabricated from a single block of metal or other material, and the multiple openings machined in the block, although this is likely to be more expensive.
[0079] As shown in Figures 4A, 4B, 4C and 4D, each half (402) (404) includes, in this embodiment, four cavities (406). Each of the cavities (406) in this embodiment includes four cavities (408), such as those described above, to align with the support members, e.g., the members (306), in the sterilization indicator bottle (300), as described in relation to Figures 3A and 3B.
[0080] As best shown in Figure 4B, and similar to the embodiment illustrated in Figure 1, each cavity (406) is tapered from top to bottom and includes inwardly, inwardly tapered sidewalls (410). In one embodiment, the cone of the inwardly tapered sidewalls (410) corresponds to the slope of the sidewall of the sterilization indicator bottle for use with the incubator block heater chassis in the system of the present invention.
[0081] As shown in Figures 4A and 4B, each cavity (406) includes a passage (412) for use with the photodetector. In practice, only one of the two passages (412) need be present, but in the illustrated embodiment of Figures 4A and 4B, the two parts (402) and (404) have such a passage as an artifact of the identity of the two parts (402) , (404) in this realization. As will be described below with reference to Figure 5, a photodetector will be aligned with each of the passages (412) in one of the two parts (402) or (404), while the passageway in the other of the two parts will be blocked. Other openings in the parts (402), (404) are used, for example, for mounting a heating element, a temperature sensor or for mounting the heater chassis (400) and other parts of the incubator block.
[0082] Figures 5A, 5B and 5C are schematic representations of parts of an assembled heater and optical chassis (520), including operating components of an incubator block for a system according to an embodiment of the present invention.
[0083] Figure 5A is a partially exploded perspective view of a heater and optical chassis (520), including parts (502), (504) corresponding to the above-described parts (402) and (404) in Figures 4A, 4B, 4C and 4D. Figure 5A shows an optical chassis (506), which is used in conjunction with the heater chassis formed by parts (502), (504) to form the optical heater chassis (520). The optical chassis (506) includes a photodetector assembly (508) and a light source assembly (510). Appropriate photodetector electronics of light source electronics can be mounted in known manner in the assembly (508) and in the assembly (510).
[0084] In the embodiment shown in Figure 5A, the parts for the exploded heater and optics chassis (520) include heater elements (512) and temperature or heat sensor (514). In the embodiment illustrated in Figure 5A, 5B and 5C, there are two heating elements (512), but any suitable number of heating elements may be used as needed to maintain the desired temperature settings selected for incubator block operation. These can be appropriately determined by the person skilled in the art. As shown in Figure 5A, the heating elements (512) and the temperature or heat sensor (514) can be mounted on the part (504) by means of screws (516). Similarly, the heater chassis formed from the parts (502), (504) can both be constructed and mounted on the optical chassis (506) by mounting additional screws (518).
[0085] Figures 5B and 5C are front (5B) and rear (5C) perspective views of an embodiment of the mounted heater and optical chassis (520), in which the heater chassis (502), (504) has been attached to the chassis optics (506), and the heaters (512) and heat sensor (514) were attached to the heater chassis using screws (516) and (518).
[0086] As shown in Figure 5B, in one embodiment, unused holes for the photodetector in part (502) or (504) are covered by a cover (522). In one embodiment, the cap (522) may be of any material suitable to block light from entering the opening and thus possibly to the photodetector, on the opposite side to which the photodetector is mounted. Power to the heater elements (512) and data reading from the temperature sensor or heater (514) is provided by wires leading from elements, as shown in Figures 5A and 5B, to the control system, by example, the control system (102) shown in Figure 1.
[0087] Figure 6 is a drawing representing a commercial embodiment of a combined sterilization indicator reader and incubator system (600) in accordance with an embodiment of the present invention. As described in relation to Figure 1, the system (600) shown in Figure 6 includes a user interface (604), a plurality of wells (608), each of which is adapted to receive and hold a sterilization indicator vial ( 610). As described above, the system (600) includes a control system that operates the user interface (604) to provide user-selected control of the incubation temperature of the sterilization indicator vial (610) placed within the well (608). In addition, the control system provides the user interface (604) with an indication of any change in output light detected by the photodetector when the sterilization indicator vial (610) is placed in the well and incubated. As described in connection with certain other embodiments, in the embodiment shown in Figure 6, the cavities (608) are adapted to conform to the outer surface of the sterilization indicator bottle. Although not well shown in Figure 6, the cavities are molded to provide contact with at least a substantial portion of the outer surface of the sterilization indicator bottle (610). In the embodiment shown in Figure 6, the system (600) further comprises a lid (630), (632) for each incubator block. In this embodiment, the caps (630), (632) are adapted to be closed only when each cavity is occupied or not occupied by a properly placed and activated sterilization indicator bottle. The system (600) illustrated in Figure 6 includes a magnetic or electrical sensor (634) that is connected to the control system and detects that the cover (630) is properly closed. In the embodiment shown in Figure 6, the sensor (634) is shown in phantom as it is below the surface and not normally visible to the user. In the event that a vial (610) is not activated or improperly placed in the cavity (608), the cap (630) will not close properly and will not make magnetic or electrical contact with the sensor (634). Any lack of contact with the sensor (634) will be reported to the control system and an appropriate indication provided on the user interface (604).
[0088] As shown in Figure 6, the user interface (604) can include a variety of readout and control functionalities by which the operation of the combined sterilization indicator reader and incubator system (600) can be controlled. The user interface can include a readout screen (640), which can display indications of the selected temperature for each incubator block, the status of each individual well with respect to, for example, whether it contains a sterilization indicator bottle (610), whether the vial (610) is properly activated, placed and filled with liquid, and whether the photodetector detects any light indicating failure of the sterilization process under evaluation.
[0089] Still referring to Figure 6, the user interface (604) may include selection buttons (642) for use, for example, in selecting incubation aspects such as incubation time and/or temperature, the identity of the particular biological indicator in the sterilization indicator bottle and the status of each well. The user interface may further comprise selection buttons (644), through which the control system and user interface are directed to focus on each individual cavity (608) at a time. The user interface may also include an indicator light (646) associated with each cavity. The indicator light (646) may indicate, for example, the presence of a vial (610) in the associated cavity (608), or that the user interface and screen (640) are currently indicating conditions for the cavity (608) to the indicator light (646) is on. Although not shown separately in Figure 6, in one embodiment, the user interface still includes an audible and/or visual alarm set to activate to notify the user that a positive result has been obtained in one or more wells. This alarm may include causing the select button (644) and/or indicator light (646) to flash on and off flash, with or without an additional audible alarm sound such as a buzzer, bell or electronic whistle. The above elements of the user interface (604) are exemplary only and additions or deletions of the various components described herein may be made by the skilled person as needed for specific applications.
[0090] Figures 7A, 7B, 7C and 7D illustrate examples of various indications that can be displayed on the screen (640) of the user interface of Figure 6, regarding the status of the wells (608) and the vials (610) that can be placed in the cavities. As shown in each of Figures 7A, 7B, 7C and 7D, the screen (640) shows the nominal temperatures of each of the two incubation heaters in this embodiment. As will be understood, in a system with more than two setter heaters (left and right), the setpoint temperature of each separate setter heater would be shown separately on the display (640).
[0091] Figure 7A illustrates an example of an initial state screen, in which both incubation heaters are set to incubate at 37°C. In this example, the screen (640) instructs the user to insert a sterilization indicator bottle (herein designated as CRONOS®, mark for the commercial realization of a sterilization indicator bottle, from STERIS Corporation, in accordance with an embodiment of the present invention) and then to select the corresponding well number by pressing the appropriate selection button (644) to start the incubation process and reading the sterilization indicator vial inserted into the well and then to monitor data from signal to be processed according to an embodiment of the present invention.
[0092] Figure 7B illustrates an example of a screen of a post-incubation and post-reading state, in which one incubation heater is set to incubate at 37°C and the other incubation heater is set to incubate at 57°C. °C. In this example, the screen (640) informs the user that the results for cavity (9) were negative and instructs the user to acknowledge the result by pressing the corresponding select button (644) to continue.
[0093] Figure 7C illustrates an example of a screen of a post-incubation and post-reading state, in which one incubation heater is set to incubate at 57°C and the other incubation heater is set to incubate at 37°C. °C. In this example, the screen (640) informs the user that the results for cavity (3) were positive and instructs the user to press the corresponding selection button (644) to silence an alarm that has been activated to warn the user that a positive result was obtained for the sterilization indicator bottle in the cavity (3).
[0094] Figure 7D illustrates an example of an error state screen, where both incubation heaters are set to incubate at 57°C. In this example, the screen (640) informs the user that the sterilization indicator bottle in the cavity (7) is in an error state and instructs the user to press the corresponding select button (644) to continue. In one embodiment, after the user presses the select button to continue, the display screen changes to inform the user that the vial in the cavity (7) has been improperly activated, improperly placed in the cavity, does not contain a liquid level enough, or is wrong for some other reason, so that the operator knows what action must be taken to correct the error state.
[0095] Figure 8 includes a graph showing exemplary incubation processes and readings in accordance with one embodiment of the present invention, in which the sterilization indicator bottles were analyzed to determine whether the sterilization process under evaluation is effective. In the embodiment shown in Figure 8, the light generated by the surviving, incubating microorganisms is fluorescence, although the light may be a different type of light as described above. As shown in Figure 8, the factory programmed threshold slope is represented by the dashed line in the graph, and exemplary slopes for four exemplary hatches are represented by solid lines in the graph.
[0096] As depicted in Figure 8, the algorithm used in the system according to the present invention does not require or acquire a base reading. The algorithm periodically records data for each cavity every, for example, 20 seconds. This ensures that an activated vial contains the proper fluid level throughout the incubation. After the appropriate incubation time (eg 3900 seconds), the reader begins to put the data into a database. A curve or line is generated from the database to calculate a slope between, for example, 3900 seconds and 5400 seconds, and this calculated slope is compared against a factory set threshold slope value. If the calculated slope is greater than the factory set threshold slope value, the sterilization indicator bottle is considered positive, indicating that the sterilization process under evaluation was not effective, ie, it failed. If the calculated slope is less than the factory set threshold slope value, incubation continues. Periodically, for example, every 1 to 5 minutes thereafter, the slope is recalculated and compared to the threshold slope value. Any slope value calculated above the threshold slope is a positive, indicating that the sterilization event under evaluation failed. If after two hours of incubation, the calculated slope never exceeds the slope threshold set at the factory, the sterilization indicator bottle is negative, meaning that the sterilization process under evaluation was successful. Note that the factory set threshold slope value (1) is not determined by an initial reading taken for each evaluation of a sterilization cycle, (2) is not specific for a given sterilization indicator bottle, (3) not is specific to the specific type of sterilization cycle being evaluated, but (4) is applicable to all sterilization indicator bottles that contain the same biological indicator, regardless of the specific type of sterilization cycle being evaluated. In one embodiment, the factory slope is slightly positive, so that not all slopes with a positive value will be read as positive for growth (and sterilization process failure), but only those whose calculated positive slopes exceed the value of the Universal and present minimum positive slope.
[0097] The factory programmed tilt above provides one of the unique advantages of the present invention as it provides for more uniform determinations of sterilization effectiveness, improves system ease of use, and reduces and therefore improves the time needed to evaluate any given sterilization process.
[0098] Although the principles of the present invention have been explained in relation to certain particular embodiments, these embodiments are provided for purposes of illustration. It should be understood that several modifications of the same will be evident to the technicians in the subject after reading the descriptive report. Therefore, it is to be understood that the present invention described herein is intended to cover such modifications that fall within the scope of the appended claims. The scope of the present invention is limited only by the scope of the claims.

权利要求:
Claims (23)
[0001]
1. COMBINED STERILIZATION INDICATOR READER AND INCUBATOR SYSTEM (100), characterized in that it comprises: a sterilization indicator bottle (110, 300, 610) containing a selected biological indicator and a liquid, in which the sterilization indicator bottle ( 110, 300, 610) comprises a building material, a bottom panel (120, 320), an inner cavity and an outer side surface, both the building material and the outer side surface adapted to transmit light emanating from the inner cavity, the bottom panel adapted to transmit light directed over the bottom panel into the inner cavity; at least two incubator blocks (1, 2...n), each incubator block independently operable to incubate the sterilization indicator bottle (110, 300, 610) at a plurality of independently selectable temperatures, each of the incubator blocks comprising: ( a) at least one heating element (114) operable to heat the incubator block to any one of the plurality of independently selectable temperatures; (b) at least one cavity (108), each cavity associated with a heating element (114), and each cavity sized to receive and hold the sterilization indicator bottle (110, 300, 610); (c) a light source (118) positioned relative to each cavity (108) to direct the light source through the bottom panel (120, 320) into the interior cavity of the sterilization indicator bottle (110, 300, 610) when the sterilization indicator bottle (110, 300, 610) is in the cavity (108); (d) a photodetector (122) positioned to detect output light emanating from the interior cavity, the photodetector (122) positioned at an angle to a direction from which the light source is directed through the panel. bottom (120) of the sterilization indicator bottle (110, 300, 610); (e) a user interface operatively communicating with a control system (102), the control system (102) including operable hardware to: separately control each heating element (114) to operate at a selected among selectable temperatures, operate the light source (118), operate the photodetector (122), operate the user interface (104), the user interface operatively communicating with the control system (102) to operate the indicator reader and incubator system. combined sterilization (100), and calculate and output data for the user interface (104) regarding the effectiveness of a sterilization process based on the output of the photodetector (122) during the incubation of the sterilization indicator vial (110, 300, 610).
[0002]
2. SYSTEM according to claim 1, characterized in that the sterilization indicator bottle (110, 300, 610) further comprises at least one support member extending radially outwardly disposed at a position along a length. minus a portion of the outer side surface.
[0003]
3. SYSTEM according to claim 2, characterized in that each cavity (108) comprises a number of slits (408) extending radially outward from the cavity (108), wherein the number and position of the slits (408) correspond to the number and position of the at least one support member (306), and wherein each cavity (108) is operatively adapted to receive the sterilization bottle (110, 300, 610) in a number of orientations corresponding to the number of slots (408).
[0004]
4. SYSTEM according to claim 3, characterized in that the sterilization indicator bottle (110, 300, 610) is adapted to provide output light transmission emanating from the interior of the sterilization indicator bottle (110, 300, 610) without regard to their rotational orientation in the cavity (108), as long as the support members (306) are aligned with and received in the slots (408).
[0005]
5. SYSTEM according to claim 1, characterized in that the angle at which the photodetector is positioned (122) is in the range of about 22° to about 158° in relation to the direction from which the source of light is directed through the bottom panel (120, 320) of the sterilization indicator bottle (110, 300, 610).
[0006]
6. SYSTEM according to claim 1, characterized in that the photodetector (122) is adapted to detect the output light of the selected output range of wavelength.
[0007]
7. SYSTEM according to claim 1, characterized in that the photodetector is adapted to detect light from the selected output range of the wavelength emanating from the interior of the sterilization indicator bottle (110, 300, 610 ).
[0008]
8. SYSTEM according to claim 1, characterized in that the output light comprises one or more photoluminescence, phosphorescence or fluorescence and a portion of the light source.
[0009]
9. SYSTEM according to claim 1, characterized in that the plurality of selectable temperatures are in the range of about 20°C to about 70°C.
[0010]
10. SYSTEM according to claim 1, characterized in that the control system is adapted to operate the user interface to provide the user with selectable temperature selection for incubation of a sterilization indicator bottle placed in a cavity and for provide indication of any change in output light detected by the photodetector when the sterilization indicator bottle is placed in the well and incubated.
[0011]
11. SYSTEM according to claim 1, characterized in that each cavity (108) is adapted to provide contact with at least a substantial portion of the outer side surface of the sterilization indicator bottle (110, 300, 610).
[0012]
12. SYSTEM according to claim 1, characterized in that the photodetector (122) is positioned to detect when the sterilization indicator bottle (110, 300, 610) (a) has been activated, (b) is correctly positioned in cavity (108) and/or (c) contains a predetermined fluid level based on the exit light.
[0013]
13. SYSTEM according to claim 12, characterized in that the system (100) is adapted to provide a signal on the user interface (104) to indicate whether any one or more of (a), (b) or (c) is not satisfied.
[0014]
14. SYSTEM according to claim 1, characterized in that the control system (102) includes hardware configured to, during incubation, periodically sample output readings from the photodetector (122) and to calculate a slope of a line obtained from a plurality of sampled output readings, for comparing the calculated slope to a predetermined threshold slope for a specific sterilization indicator contained in the sterilization bottle (110, 300, 610), and for providing the output data related to the effectiveness of the sterilization process based on the comparison.
[0015]
15. SYSTEM according to claim 14, characterized in that the control system (102) is configured to provide the output data based only on the comparison of the calculated slope to the predetermined threshold slope without first determining a baseline or minimum value of the photodetector output.
[0016]
16. SYSTEM according to claim 1, characterized in that the system further comprises a separate cover for each incubator block, in which the cover and the incubator block are configured so that the cover can be closed only when each cavity is unoccupied or occupied by a properly placed and activated sterilization indicator bottle.
[0017]
17. METHOD OF DETERMINING THE EFFECTIVENESS OF A STERILIZATION PROCESS, characterized in that it comprises: providing the combined sterilization indicator reader and incubator system as described in claim 1; expose the sterilization indicator bottle to a sterilization process under conditions designed to sterilize the biological indicator; and operating the system to determine if the sterilization process was effective.
[0018]
18. METHOD OF DETERMINING THE EFFECTIVENESS OF A STERILIZATION PROCESS, characterized in that it comprises: providing the combined sterilization indicator reader and incubator system as described in claim 1 and operating the heating element associated with a selected of the at least one cavity at one of the plurality of selectable temperatures; exposing the sterilization indicator bottle to a sterilization process under conditions designed to sterilize a specific type of biological indicator contained in the sterilization indicator bottle; activate the exposed sterilization indicator bottle and insert the activated sterilization indicator bottle into the selected cavity; confirm that the activated sterilization indicator vial has been activated, is correctly positioned in the selected cavity and contains a predetermined fluid level, directing the light through the bottom panel into the interior cavity of the sterilization indicator vial, detect the light of output emerging from the interior cavity with the photodetector, and providing confirmation or lack thereof to the control system; after confirmation, incubate the biological indicator in the activated sterilization indicator bottle; during incubation, directing a light source through the bottom panel into the interior cavity, and operating the photoelectric cell to detect the exit light emanating from the interior cavity; and operate the control system to calculate and produce data for the control system based on the output from the photodetector during incubation to determine whether the sterilization process was effective, and provide a user interface signal indicative of efficacy or lack of this.
[0019]
19. METHOD according to claim 18, characterized in that the operation of the control system comprises periodically sampling output readings from the photodetector during incubation, calculating a slope of a line obtained from a plurality of readings output samples, compare the calculated slope to a predetermined threshold slope for the specific type of biological indicator contained in the sterilization bottle, and provide the signal in the user interface based on the comparison.
[0020]
20. METHOD, according to claim 19, characterized in that the data relating to the effectiveness of the sterilization process are based only on the comparison of the calculated slope to the predetermined threshold slope and the calculated slope is determined without first determining a baseline or minimum value of the photodetector output.
[0021]
21. METHOD according to claim 20, characterized in that the sterilization process is considered to have failed when the calculated slope is equal to or exceeds the slope of predetermined threshold.
[0022]
22. METHOD, according to claim 18, characterized in that two of the sterilization indicator bottles are simultaneously incubated at two different temperatures separately from the incubator blocks.
[0023]
23. METHOD according to claim 18, characterized in that the output light detected by the photodetector comprises one or more of photoluminescence, phosphorescence and fluorescence.

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法律状态:
2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-06-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-08-03| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/09/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US14/090,116|US9303283B2|2013-11-26|2013-11-26|Combined sterilization indicator incubator and reader system|

US14/090,116|2013-11-26|

PCT/US2014/054922|WO2015080777A1|2013-11-26|2014-09-10|Combined sterilization indicator incubator and reader system|

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