BIOLOGICAL STERILIZATION INDICATOR

专利摘要:
biological sterilization indicator This is a biological sterilization indicator (ib) and a method of using it to test the lethality of a sterilization process. ib may include a compartment, which may include a first portion (104), and a second portion (106), which may be movable with respect to the first portion between a first and second position. the ib can also include a frangible container (120) comprising a liquid. the ib can include a spore reservoir (114) and a ledge (158) positioned in the compartment. the protrusion can be configured to fracture the container when the second position of the container is moved from the first position to the second position. the method may include maintaining a minimum cross-sectional area of space around the container when the second portion of the compartment is in the first position, and fracturing the container in response to the movement of the second portion between the first and second positions.
公开号:BR112012001409B1
申请号:R112012001409-9
申请日:2010-07-06
公开日:2021-03-30
发明作者:Jeffrey D. Smith；Sailaja Chandrapati；Jeffrey C. Pederson
申请人:3M Innovative Properties Company；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] This description refers, in general, to sterilization indicators and, in particular, to biological sterilization indicators. BACKGROUND OF THE INVENTION
[0002] In a variety of industries, such as the healthcare industry and also in other industrial applications, it may be necessary to monitor the effectiveness of processes used to sterilize equipment such as medical devices and other disposable and non-disposable items. In these scenarios, sterilization is, in general, defined as processes that completely destroy all viable microorganisms including structures such as viruses and spores. As a standard practice, hospitals include a sterility indicator with a batch of articles to test the lethality of the sterilization process. Both biological and chemical indicators of sterilization have been used.
[0003] A standard type of biological sterilization indicator includes a known quantity of test microorganisms, for example spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus) or Bacillus atrophaeus (formerly Bacillus subtilis), which are often more resistant to a process of sterilization than most contaminating organisms. After the indicator is exposed to the sterilization process, the spores can be incubated in a nutrient medium to determine whether any spores have survived the sterilization process, with spore growth indicating that the sterilization process was insufficient to destroy all microorganisms. Although advances have been made, the period of time to determine this reliably can be undesirably long.
[0004] Chemical sterilization indicators can be evaluated immediately at the end of the sterilization process. However, the results only indicate that a particular condition was present during the sterilization process, such as the presence of a particular chemical or temperature, and potentially, that the condition was achieved over a period of time.
[0005] In general, it is considered that the response of living organisms to all conditions actually present is a more direct and reliable test to verify how effective a sterilization process is in achieving sterilization. Consequently, there is a continuing need for biological sterilization indicators, which can indicate the effectiveness of a sterilization process without excessive delay after the sterilization process has ended, and which can also provide a high level of confidence that various sterility parameters were achieved in the sterilization process. DESCRIPTION OF THE INVENTION
[0006] One aspect of the present description provides a biological indicator of sterilization. The biological sterilization indicator can include a compartment, which includes a first portion and a second portion adapted to be coupled to the first portion. The second portion can be movable with respect to the first portion between a first position and a second position. The biological indicator of sterilization may additionally include a container that comprises a liquid. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The biological sterilization indicator can additionally include a spore reservoir positioned in the compartment, and a ledge positioned in the compartment. The protrusion can be configured to (a) keep the container intact in a location in the compartment where a minimum cross-sectional area of space between the container and at least one of the compartment and the projection is maintained when the second portion of the compartment is in the first position, and (b) fracture the container when the second portion of the compartment is moved from its first position to the second position.
[0007] Another aspect of the present description presents a biological indicator of sterilization. The biological sterilization indicator may include a compartment, which may include a first portion, and a second portion adapted to be coupled to the first portion. The second portion can be movable with respect to the first portion between a first position and a second position. The biological indicator of sterilization may additionally include a container that comprises a liquid. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The biological sterilization indicator can additionally include a spore reservoir positioned in the compartment, a support positioned to keep the container intact in a location in the compartment when the second position of the compartment is in the first position, and a projection positioned to fracture the container when the second portion of the compartment is moved from its first position to the second position. The support can be positioned to allow the container to move in response to the movement of the second portion of the compartment between its first position and the second position. In addition, the support can be positioned to maintain at least a minimum cross-sectional area of defined space between the container and at least one of the compartment, support, and protrusion.
[0008] Another aspect of the present description presents a method for testing the lethality of the sterilization process. The method may include providing a biological sterilization indicator that includes a compartment, which may include a first portion, and a second portion adapted to be coupled to the first portion. The second portion of the compartment can be movable with respect to the first portion between a first position and a second position. The method may further include providing a container comprising a liquid. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The method may also include the provision of a spore reservoir positioned in the compartment. The method may also include maintaining a minimum cross-sectional area of space around the container when a second portion of the compartment is in the first position. The method may further include moving the second portion of the compartment with respect to the first portion of the compartment from the first position to the second position, and fracturing the container in response to the movement of the second portion from the first position to the second position.
[0009] Other characteristics and aspects of the present description will become evident upon consideration of the detailed description and the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Figure 1 is an exploded perspective view of a biological indicator of sterilization according to an embodiment of the present description, in which the biological indicator of sterilization includes an insertion element.
[0011] Figure 2 is a side cross-sectional view of the biological sterilization indicator of figure 1, before activation.
[0012] Figure 3 is a side cross-sectional view of the biological sterilization indicator in figures 1 and 2, after activation.
[0013] Figure 4 is a top cross-sectional view of the biological sterilization indicator in figures 1 to 3, before activation.
[0014] Figure 5 is a perspective view of the insertion elements of figures 1 to 4.
[0015] Figure 6 is a side cross-sectional view of a biological sterilization indicator according to another embodiment of the present description.
[0016] Figure 7 is a top cross-sectional view of the biological sterilization indicator in figure 6.
[0017] Figure 8 is a side cross-sectional view of a biological sterilization indicator according to another embodiment of the present description.
[0018] Figure 9 is a top cross-sectional view of the biological sterilization indicator in figure 8, with portions removed for clarity.
[0019] Figure 10 is an exploded perspective view of a biological indicator of sterilization according to another embodiment of the present description.
[0020] Figure 11 is a side cross-sectional view of the biological sterilization indicator of figure 10, before activation.
[0021] Figure 12 is a side cross-sectional view of the biological sterilization indicator in figures 10 and 11, after activation.
[0022] Figure 13 is a cross-sectional view of the biological sterilization indicator in figures 10 to 12.
[0023] Figure 14 is a perspective view of an insertion element according to another embodiment of the present description.
[0024] Figure 15 is a perspective view of an insertion element according to another embodiment of the present description.
[0025] Figure 16 is a perspective view of an insertion element in accordance with the present description.
[0026] Figure 17 is a perspective view of an insertion element in accordance with the present description. DESCRIPTION OF REALIZATIONS OF THE INVENTION
[0027] Before any of the modalities of this description are explained in detail, it should be understood that the invention is not limited, in its application, to the details of the construction and arrangement of the components set out in the description below or illustrated in the drawings below . The invention can comprise other modalities and be practiced or carried out in several ways. It should also be understood that the phraseology and terminology used in the present invention have a descriptive purpose, and should not be considered limiting. The use of "including", "comprising", or "having" and the variations thereof thereof of the present invention are intended to cover the items mentioned after them and their equivalents as well as additional items. Except where specified, or when limited in some way, the terms "sustained" and "coupled" and variations thereof, are widely used and include direct and indirect supports and couplings. In addition, "connected" and "coupled" are not restricted to physical or mechanical connections or couplings. It should be understood that other modalities can be used and structural or logical changes can be made without departing from the scope of this description. In addition, the terms such as "front part", "rear part", "top", "bottom" and the like are used only to describe the mutual relationship between the elements, however, they are in no way intended to refer to the specific guidelines of the device, indicate or check necessary or required device guidelines or specify how the invention described herein will be used, assembled, displayed or positioned in use.
[0028] The present description refers, in general, to a sterilization indicator, and particularly, to a biological sterilization indicator. A biological indicator of sterilization is sometimes referred to as a "biological indicator of sterility", or simply, a "biological indicator". Some modalities of biological sterilization indicator of the present description are one-piece, and can be used to determine the lethality of the sterilization process. This description refers, in general, to the construction of a biological sterilization indicator that allows one or more of at least the following actions: storing in a compartment the liquid separated from the spores during sterilization to combine the liquid and spores after the sterilization; keep a frangible container (for example, an ampoule) that contains the liquid (for example, in a separate location from the spores on the biological sterilization indicator during sterilization); releasing the liquid from the frangible container (for example, during activation of the biological sterilization indicator) and / or controlling the movement of the liquid to a spore location on the biological sterilization indicator; allowing the movement of the container in the biological sterilization indicator; provide a substantially constant sterilizing trajectory; collect and / or retain portions of the fractured container (for example, to inhibit the movement of fractured portions in the vicinity of the spores); and / or minimize the spread of spores and / or distant signals in a spore location or a detection region for the biological sterilization indicator (for example, to enhance detection).
[0029] In general, microorganisms are chosen to be used in a biological sterilization indicator, which are resistant to a particular sterilization process. The biological indicators of sterilization of the present description include a viable culture of a known species of microorganism, usually in the form of microbial spores. The test microorganism in the biological sterilization indicator is killed by a successful sterilization cycle, or survives if the sterilization cycle is not suitable for some reason. Bacterial spores, in addition to the vegetative form of organisms, are sometimes used at least partially because vegetative bacteria are known to be killed with relative ease by sterilization processes. Spores also have superior storage characteristics and can remain in their latent state for years. As a result, sterilization of an inoculum from a standardized spore strain provides a high degree of confidence that the inactivation of all microorganisms in a sterilization chamber has occurred successfully.
[0030] As an example, this description describes the microorganisms used in the biological indicator of sterilization as being "spores"; however, it must be understood that the type of microorganism (for example, spore) used in a particular modality of the biological sterilization indicator is selected because it is highly resistant to the particular sterilization process contemplated. Consequently, different modalities of the present description can use different microorganisms, depending on the sterilization process for which the modality is intended. The term "spores" is used from the beginning to the end of this description for the sake of simplicity, but it should be understood that other forms of microorganism, enzymes, or a combination of them, can be used in the biological indicator of sterilization of the present description .
[0031] The biological sterilization indicator of this description can be used with a variety of sterilization processes that include, but are not limited to, exposure to water vapor (eg, pressurized water vapor), dry heat, gaseous or liquid agents (for example, ethylene oxide, hydrogen peroxide, paracetic acid, ozone, or combinations thereof. In at least some of the sterilization processes, an elevated temperature, for example, 50 ° C, 100 ° C, 121 ° C, 132 ° C, 134 ° C, or similar, is included or can be found in the process In addition, high pressures and / or vacuum can be found, for example, 1 X 105 Pa (15 psi)
[0032] The spores used in a particular system are selected according to the sterilization process used. For example, for a water vapor sterilization process, Geobacillus stearothermophilus or Bacillus stearothermophilus can be used. In another example, for an ethylene oxide sterilization process, Bacillus atrophaeus (formerly Bacillus subtilis) can be used. In some embodiments, spores resistant to the sterilization process may include, but are not limited to, Geobacillus stearothermophilus, Bacillus stearothermophilus, Bacillus subtilis, Bacillus atrophaeus, Bacillus megaterium, Bacillus coagulans, Clostridium sporogenes, Bacillus pumilus, Bacillus pumilus combinations.
[0033] Enzymes and substrates that may be suitable for use in the biological sterilization indicator of this description are identified in US patents No. 5,073,488 (Matner et al), 5,418,167 (Matner et al.), And 5,223,401 (Foltz et al.), Which are incorporated by reference and in the entirety of their descriptions.
[0034] Suitable enzymes may include hydrolytic enzymes and / or enzymes derived from spore-forming microorganisms, such as Bacillus stearothermophilus and Bacillus subtilis. Spore-forming microorganism enzymes that may be useful in the biological sterilization indicators of the present description may include beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyl esterase, lipase caprylate esterase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, alpha-D-galactosidase, beta-D-galactosidase, tyrosine aminopeptidase, phenylalanine aminopeptidase, beta-D-glucuronidase, alpha-L-arabinofuranosidase, N-acetyl-beta-aminosulfase -celobiosidase, alanine aminopeptidase, proline aminopeptidase and fatty acid esterases.
[0035] Chromogenic and fluorogenic substrates which react with enzyme to form detectable products, and which are suitable for use in the sterilization indicator of the present description, are well known in the art. (M. Roth, Methods of Biochemical Analysis, Vol. 17, D. Block, Ed., Interscience Publishers, New York, 1969, p. 89, incorporated herein by reference; S. Udenfriend, Fluorescence Assay in Biology and Medicine , Academic Press, New York, 1962, p. 312; and DJR Lawrence, Fluorescence Techniques for the Enzymologist, Methods in Enzymology, Vol. 4, SP Colowick and NO Kaplan, Eds., Academic Press, New York, 1957, p. 174). These substrates can be classified into two groups based on the way in which they create a visually detectable signal. The substrates in the first group react with enzymes to form enzyme-modified products that are chromogenic or fluorescent. The substrates in the second group form products modified by enzymes that still need to react with an additional compound, or compounds, to generate a color or fluorescent signal.
[0036] In some embodiments, the source of the active enzyme may be (1) the isolated purified enzyme derived from an appropriate microorganism; (2) a microorganism to which the enzyme is native or added by genetic engineering; and / or (3) a microorganism to which the enzyme was added during sporulation or growth, so that the enzyme is incorporated or associated with the microorganism, for example, an enzyme added to a spore during sporulation that becomes incorporated within the spore. In some embodiments, microorganisms that can be used as an enzyme source include bacteria or fungi in the spore or vegetative state. In some embodiments, the enzyme source includes Bacillus, Clostridium, Neurospora, Candida, or a combination of these species of microorganisms.
[0037] The enzyme alpha-D-glucosidase has been identified in the spores of Bacillus stearothermophilus, such as those commercially available as "ATCC 8005" and "ATCC 7953" from the American Type Culture Collection, Rockville, Md, USA. The beta-D-glucosidase enzyme was found in B. subtilis (for example, commercially available as "ATCC 9372" from the American Type Culture Collection).
[0038] In the event that an isolated enzyme is used, or the microorganism used as the source of the enzyme is no more resistant to sterilization conditions than natural contaminants, another microorganism commonly used to monitor sterilization conditions can be exposed to the cycle sterilization along with the enzyme source. In that case, the method of the present description can include the step of incubating any viable microorganism remaining after the sterilization cycle with an aqueous nutrient medium to confirm the sterilization efficacy.
[0039] In general, monitoring the effectiveness of the sterilization process may include placing a biological sterilization indicator in a sterilizer. In some embodiments, the sterilizer includes a sterilization chamber that can be sized to accommodate a plurality of articles to be sterilized, and can be equipped with a means of evacuation air and / or other gases from the chamber and a means for adding a sterilizing to the chamber. The biological sterilization indicator of the present description can be positioned in areas of the sterilizer that are more difficult to sterilize (for example, above the drain). Alternatively, the biological sterilization indicator of the present description can be positioned adjacent (or generally in proximity to) an article to be sterilized when the biological sterilization indicator is positioned in the sterilization chamber. In addition, the biological sterilization indicator can be positioned on process challenge devices that can be used as sterilizers.
[0040] The sterilization process may also include the exposure of articles to be sterilized and the biological indicator of sterilization to a sterilizer. In some embodiments, the sterilizer can be added to the sterilization chamber after evacuating at least a portion of the chamber from any air or other gas present in it. Alternatively, the sterilizer can be added to the chamber without evacuating it. A series of evacuation steps can be used to ensure that the sterilizer reaches all desired areas within the chamber and contacts all items to be sterilized, including the biological sterilization indicator.
[0041] In general, after the biological sterilization indicator has been exposed to a sterilization cycle, a liquid (for example, a growth medium, water that can be mixed with a solid growth medium, etc., or combinations of the themselves) can be introduced to the spores. The stage in which the liquid is introduced to the spores can be called the "activation stage". If the spores have survived the sterilization cycle, the liquid will facilitate spore growth, and that growth medium can be investigated. If growth is observed, the sterilization cycle is generally considered to be ineffective.
[0042] Some existing systems include a glass ampoule inside the biological indicator that can be broken by squeezing or flexing the biological indicator (for example, by hand), or by pressing a cap against the ampoule, forcing the ampoule to fracture with cap. These existing systems, however, can have several limitations and potential risks associated with them.
[0043] Fracture of the ampoule when flexing or tightening the biological indicator can potentially cause bodily injury if the broken glass cuts through the wall of the biological indicator. This can be particularly problematic if the biological indicator is still warm when leaving a sterilization cycle that has softened the walls of the biological indicator. Bending of the biological indicator can also create opaque folds caused by excessive pressure on the wall of the biological indicator (for example, if the wall is formed of plastic), which can interfere with the detection of spore growth (for example, if optical methods are used to elucidate spore growth).
[0044] Furthermore, in existing systems that employ a cap-activated ampoule rupture, the ampoule rupture can be performed by forcing the ampoule in a constriction, causing it to fracture. The amount of force required to fracture the ampoule with these methods can be quite high, which creates an ergonomic problem for the user. Some existing systems that use cap activation include wedges or shims attached to the cap that attach against the wall of the ampoule to fracture it. In these systems, the ampoule is often broken near the top of the ampoule (for example, adjacent to the midpoint of the ampoule or higher), which can leave the lower section of the ampoule intact, which allows the ampoule liquid to be retained in the bottom of the ampoule, and that can reduce the amount of liquid that is available to the spores. In addition, in some existing systems, portions of the ampoule or frangible container (eg, glass fragment) can accumulate near the spores, which can reduce the availability of the liquid to the spores, and can interfere with the detection of spore growth.
[0045] Some modalities of the present description, on the other hand, provide an ideal and safe rupture of a frangible container with relatively low strength, while accentuating the transfer of liquid to the spore region of the biological sterilization indicator, and / or confinement of the liquid in the spore region of the biological sterilization indicator. In addition, some embodiments of the present description operate to direct a liquid to a particular area of the biological sterilization indicator, such as a spore detection area of the biological sterilization indicator.
[0046] Figures 1 to 5 illustrate a biological sterilization indicator 100 according to an embodiment of the present description. The biological sterilization indicator 100 may include a compartment 102, which may include a first portion 104 and a second portion 106 (e.g., a lid) adapted to be coupled thereto to provide the one-piece biological sterilization indicator. In some embodiments, the first portion 104 and the second portion 106 may be formed from the same materials, and in some embodiments, the first portion 104 and the second portion 106 may be formed from different materials.
[0047] The compartment 102 can be defined by at least one liquid impermeable wall, such as the wall 108 of the first portion 104 and / or a wall 110 of the second portion 106. It should be understood that a unitary compartment of a part 102 can also be employed or that the first and second portions 104 and 106 can assume other shapes and dimensions in relative structures without deviating from the character and scope of the present description. Suitable materials for compartment 102 (for example, walls 108 and 110) may include, but are not limited to, a glass, a metal (for example, foil), a polymer (for example, polycarbonate, polypropylene, polyethylene, polystyrene, polyester, polymethyl methacrylate (PMMA or acrylic), acrylonitrile butadiene styrene (ABS), cycle olefin polymer (COP), cycle olefin copolymer (COC), polysulfone (PSU), polyether sulfone (PES), polyetherimide (PEI) , polybutyleneterephthalate (PBT)), ceramic, porcelain, or combinations thereof.
[0048] In some embodiments, the biological sterilization indicator 100 may additionally include a frangible container 120 containing a liquid 122. The frangible container 120 for being formed by a variety of materials, including, but not limited to, a or more of metal (for example, metal foil, a polymer (for example, any of the polymers mentioned above in relation to compartment 102), glass (for example, a glass ampoule), and combinations thereof. In some embodiments, only a portion of the container 120 is frangible, for example, the container 120 can include a frangible lid (for example, a frangible barrier, film or membrane, or the like). Figure 4 shows an upper cross-sectional view of the biological indicator of sterilization 100 obtained at a location near the bottom of the container 120.
[0049] The first portion 104 of compartment 102 can be adapted to house most components of the biological sterilization indicator 100. The compartment 102 can include a reservoir 103 that can be defined by one or both of the first portion 104 and the second portion 106 of compartment 102. The biological sterilization indicator 100 can additionally include spores 115 or a spore location positioned in fluid communication with reservoir 103. As shown in figure 1, the second portion 106 of compartment 102 can include one or more openings 107 to provide fluid communication between the interior of compartment 102 (e.g., reservoir 103) and ambience. For example, one or more openings 107 can provide fluid communication between spores 115 and the environment during the sterilization process, and can serve as an input to the biological sterilization indicator 100 and as an input to a sterilizing path 164 (described in more details below). In some embodiments, as shown in figure 2, the second portion 106 of compartment 102 can be coupled to a first end 101 of the first portion 104 of compartment 102, and spores 115 can be positioned at a second end 105, opposite the first end 101, of the first portion 104 of compartment 102.
[0050] In some embodiments, a barrier (for example, a sterile barrier; not shown) can be positioned in the path of sterilizer 164 (for example, in an entrance formed by opening 107) to inhibit contamination or prevent foreign organisms, objects or materials enter the biological sterilization indicator 100. This barrier may include a gas transmissive material and is impermeable to microorganisms, and may be attached to compartment 102 with a variety of coupling means, including, but not limited to, an adhesive , a heat seal, sonic welding, or the like. Alternatively, the barrier can be coupled to the sterilizing path 164 via a support structure (such as a second portion 106) that is coupled to the first portion 104 of compartment 102 (for example, in a quick-fit coupling, a coupling by screw, a pressure coupling, or a combination thereof). During exposure to a sterilizer, it can cross the barrier in the trajectory of sterilizer 164 and come in contact with spores 115.
[0051] In some embodiments, as shown in figures 1 to 5, compartment 102 may include a lower portion 114 and an upper portion 116, which may be partially separated by an inner wall 118, protrusion, partition, or the like, wherein an opening system 117 can be formed which provides fluid communication between the lower portion 114 and the upper portion 116. In some embodiments, as shown in figures 1 to 5, the lower portion 114 of the first portion 104 of compartment 102 (sometimes called "the lower portion 114" or "the lower portion 114 of compartment 102" for the sake of simplicity, or as the "spore growth chamber") can be adapted to the spore compartment 115 or a spore site. In some embodiments, the lower portion 114 may be called the "detection portion" or "detection region" of compartment 102, because at least a portion of the lower portion 114 may be interrogated for signs of spore growth. In addition, in some embodiments, the upper portion 116 of the first portion 104 of compartment 102 (sometimes called "the upper portion 116" or "the upper portion 116 of compartment 102" for the sake of simplicity) can be adapted to accommodate at least at least a portion of the frangible container 120, particularly, before activation.
[0052] In some embodiments, the wall 118 (sometimes referred to as the "separation wall") can be angled or tilted, for example, oriented at an angle other than zero and not straight in relation to the longitudinal direction D1 of compartment 102 ( for example, where the longitudinal direction D1 extends along the length of compartment 102). This angulation or inclination of the wall 118 can facilitate the movement of the liquid 122 from the upper portion 116 to the lower portion 114 after sterilization and after the container 120 has been ruptured to release the liquid 122.
[0053] In some embodiments, liquid 122 may include a nutrient medium for the spores, such as a germination medium that will promote the germination of the surviving spores. In some embodiments, liquid 122 may include water (or another solvent) that can be combined with nutrients to form a nutrient medium. Suitable nutrients may include nutrients necessary to promote the germination and / or growth of surviving spores in a dry form (eg, powdered form, tablet form, caplet form, capsule form, film or coating, trapped in a microsphere or other support, another suitable shape or configuration, or a combination thereof) in reservoir 103, for example, in a region of the biological sterilization indicator 100 next to the spores 115.
[0054] The nutrient medium is, in general, selected to induce the germination and initial flowering of the spores, if this is feasible. The nutrient medium can include one or more sugars, including, but not limited to, glucose, fructose, celibiose, or the like, or a combination thereof. The nutrient medium may also include a salt, including, but not limited to, potassium chloride, calcium chloride, or the like, or a combination thereof. In some embodiments, the nutrient may also include at least one amino acid, including, but not limited to, at least one of methionine, phenylalanine, and tryptophan.
[0055] In some embodiments, the nutrient medium may include indicator molecules, for example, indicator molecules that have optical properties that are altered in response to germination or spore growth. Suitable indicator molecules may include, but are not limited to, pH indicator molecules, enzyme substrates, DNA-binding dyes, RNA-binding dyes, other suitable indicator molecules, or a combination thereof.
[0056] As shown in figures 1 to 5, the biological sterilization indicator 100 can also include an insertion element 130. In some embodiments, the insertion element 130 can be adapted to hold or transport container 120 so that container 120 is kept intact in a location separate from spores 115 during sterilization. That is, in some embodiments, the insert 130 may include (or function as) a support 132 for the container 120, particularly, before the container 120 is ruptured during the activation step (i.e., the step in which the liquid 122 is released from container 120 and introduced into spores 115, which typically occurs after a sterilization process).
[0057] In some embodiments, the insertion element 130 can be further adapted to allow the container 120 to move in compartment 102, for example, longitudinally in relation to compartment 102. This movement can be provided by a connector 134. An example of a connector 134 is illustrated in figures 1 to 5 and includes a joint or bend 135 to allow connector 134 to be flexible. Other suitable structures that allow the container 120 to remain held by the support 132 and to be moved in the compartment 102 can also be employed, such as a skewed element (for example, a spring), a variable length connector (for example, a telescopic connector ), or similar, or combinations thereof.
[0058] In some embodiments, the insert 130 may additionally be adapted to accommodate the spores 115. For example, as shown in figures 1 to 5, in some embodiments, the insert 130 may include a spore reservoir 136, wherein the spores 115 can be positioned, either directly or on a substrate. In embodiments that employ a nutrient medium that is positioned to be mixed with liquid 122 when it is released from container 120, the nutrient medium can be positioned close to or within the spore reservoir 136, and the nutrient medium can be mixed with (for example, dissolved in) water when water is released from container 120. Just as an example, in modalities in which the nutrient medium is supplied in a dry form, the dry form may be present within the reservoir 103 , the spore reservoir 136, on a substrate for the spores, or a combination thereof. In some embodiments, a combination of liquid and dry nutrient media can be employed.
[0059] In some embodiments, the spores 115 can be positioned directly in the lower 114 portion of compartment 102, or the spores 115 can be positioned in a spore reservoir, such as the spore reservoir 136 (for example, provided by the insertion element 130 in the embodiment illustrated in figures 1 to 5). If spores 115 are positioned directly in the lower portion 114 of compartment 102 or in a spore reservoir, such as spore reservoir 136, spores 115 can be provided in a variety of ways. In some embodiments, the spores 115 may be a spore suspension that can be positioned at a desired location on the biological sterilization indicator 100 and subjected to drying. In some embodiments, the spores 115 can be supplied on a substrate (not shown) that can be positioned and / or secured at a desired location on the biological sterilization indicator 100. Some modalities may include a combination of spores 115 supplied in a dry form and spores 115 provided on a substrate.
[0060] In some embodiments, the substrate can be positioned to support spores 115 and / or help keep spores 115 in a desired location. Such substrate may include a variety of materials, including, but not limited to, paper, a polymer (for example, any of the polymers mentioned above in relation to compartment 102), an adhesive (for example, acrylate, synthetic or natural rubber) , silicone, silicone polyurea, isocyanate, epoxy, or combinations thereof), a woven cloth, a non-woven cloth, a microporous material (for example, a microporous polymeric material), a reflective material (for example, a foil) , glass, porcelain, ceramics, a gel-forming material (for example, guar gum), or combinations thereof. In addition, or alternatively, this substrate may include or be coupled to a hydrophilic coating to facilitate intimate contact of the liquid 122 with the spores 115 (for example, when the liquid 122 employed is aqueous). In addition, or alternatively, this hydrophilic coating can be applied to any fluid path positioned to fluidly couple liquid 122 and spores 115. In some embodiments, in addition to, or in place of, a hydrophilic coating, a coating hydrophobic can be applied to other portions of compartment 102 (for example, the lower portion 114 of compartment 102) and / or of the spore reservoir 136, so that the liquid 122 is moved preferentially to come in contact with the spores 115.
[0061] In some embodiments, the insert 130 does not include the spore reservoir 136. In some embodiments, the spore reservoir 136 is provided by the lower portion 114 of compartment 102 itself, and the spores 115 can be positioned in the portion lower 114, adsorbed on an inner wall of the lower portion 114, or combinations thereof. In some embodiments, the spores 115 may be provided on a substrate that is positioned in the lower portion 114 of compartment 102. In some embodiments, the portion of reservoir 103 that is defined at least partially by the upper portion 116 of compartment 102 may be called a "first reservoir" 109 and the portion of reservoir 103 which is defined at least partially by the lower portion 114 of compartment 102 can be called "second reservoir" 111, and the first reservoir 109 and second reservoir 111 can be positioned in fluid communication with each other to allow a sterilizer and liquid 122 to move from the first reservoir 109 to the second reservoir 111. In some embodiments, the degree of fluid connection between the first reservoir 109 and the second reservoir 111 (for example, the size opening system, such as the opening system 117, which connects the first reservoir 109 and the second reservoir 111) can increase after, simultaneously with, and / or in response to the activation step (i.e., the liquid 122 being released from the container 120). In some embodiments, the control of fluid communication (or extension of fluid connection) between the first reservoir 109 (for example, the upper portion 116) and the second reservoir 111 (for example, the lower portion 114) can be provided by at least a portion of the insert 130.
[0062] As shown in figures 2 and 3, the second portion 106 of compartment 102 can be adapted to be coupled to the first portion 104. For example, as shown in figures 1 to 4, the second portion 106 can be adapted to be coupled to the upper portion 116 of the first portion 104 of compartment 102. In some embodiments, as shown in figures 1 to 4, the second portion 106 may be in the form of a lid that can be sized to receive at least a portion of the first portion 104 of the compartment 102.
[0063] As shown in figure 2, during sterilization and before activation, the second portion 106 can be in a first position 148 in relation to the first portion 104. As shown in figure 3, after sterilization, the biological sterilization indicator 100 can be activated to release liquid 122 from container 120 to move liquid 122 to spores 115. That is, the second portion 106 of compartment 102 can be moved to a second position 150 with respect to the first portion 104. Only for example, in the embodiment illustrated in figures 1 to 4, the first portion 104 of compartment 102 includes a step or projection 152 on its outer surface, and the second portion 106 includes a rim or protuberance 154 that can be adapted to engage with step 152 in a first portion 104 when the second portion 106 is moved from the first position 148 to the second position 150. In these embodiments, the second portion 106 can be reversibly engaged with the first portion 104 in the second position 150, and in some embodiments, the second portion 106 may engage irreversibly with the first portion 104.
[0064] A variety of coupling means may be employed between the first portion 104 and the second portion 106 of compartment 102 to allow the first portion 104 and the second portion 106 to be removably coupled to each other, including, but not limited to, limited to, gravity (for example, one component can be fixed on top of another component, or a joined portion thereof), thread threads, press fit couplings (sometimes called "friction fit coupling" or "forced fit hitch"), snap fit hitch, magnets, adhesives, heat seal, other suitable removable coupling means, and combinations thereof. In some embodiments, the biological sterilization indicator 100 does not need to be reopened and the first portion 104 and the second portion 106 do not need to be coupled to each other, but instead can be coupled permanently or semi-permanently to each other. These permanent or semi-permanent coupling means may include, but are not limited to, adhesives, sutures, staples, threads, nails, rivets, headless nails, crimping, welding (eg sonic welding (eg ultrasonic) )), any heat seal technique (for example, heat and / or pressure applied to one or both components to be coupled), press fit coupling, press fit coupling, heat sealing, other permanent coupling means or semi-permanent and combinations thereof. The person skilled in the art will recognize that some of the semi-permanent or permanent coupling means can also be adapted to be removable and vice versa, and are categorized in this way for example only.
[0065] In the embodiment illustrated in figures 1 to 4, the second portion 106 is shown as movable between a first longitudinal position 148 with respect to the first portion 104 and a second longitudinal position 150 with respect to the first portion 104; however, it should be understood that the biological sterilization indicator 100 can be configured differently, so that the first and second positions 148 and 150 are not necessarily longitudinal positions in relation to one or both of the first portion 104 and the second portion 106 of compartment 102.
[0066] The second portion 106 may further include a seal 156 (for example, a protrusion, a protuberance, a flap, a flange, a sealing ring, or the like, or combinations thereof) that can be positioned to contact an end open top 157 from first position 104 of compartment 102 to close or seal (for example, hermetically seal) the sterilization biological indicator 100 after the second portion 106 has been moved to the second position 150, and the liquid 122 has been released from the container 120. The seal 156 can take a variety of shapes and is shown in figures 2 and 3, by way of example, forming an inner ring that together with the wall 110 of the second portion 106 is dimensioned to receive the upper end 157 of the first portion 104 of compartment 102 to seal the biological sterilization indicator 100.
[0067] In some embodiments, the coupling between the seal 156 and the upper end 157 of the first portion 104 of the compartment 102 can be used in addition to, or in place of, the coupling between the step 152 and the protrusion 154 described above. For example, one or both, the seal 156 and / or the upper end 157 may further include a structure (for example, a protuberance) configured to engage the other of the upper end 157 and the seal 156, respectively, for coupling the second portion 106 of compartment 102 to the first portion 104 of compartment 102.
[0068] In addition, in some embodiments, the second portion 106 of compartment 102 can be coupled to the first portion 104 of compartment 102 (for example, by step 152 and protrusion 154 and / or seal 156 and upper end 157 of the first portion 104 of compartment 102) to seal the sterilization biological indicator 100 to create an ambience after activation. This seal can inhibit contamination or spillage of liquid 122 after it has been released from container 120, and / or can inhibit contamination inside the biological sterilization indicator 100.
[0069] The insertion element 130 will now be described in more detail, with particular reference to figure 5. As shown in figure 5 and mentioned above, in some embodiments, the insertion element 130 may include a support 132. In the embodiment illustrated in Figures 1 to 5, support 132 includes three arms 142 which are connected together by a bowl-shaped base 144, and arms 142 and base 144 are shaped and dimensioned to hold a portion of the container 120. Only as an example , the arms 142 and the base 144 are illustrated as shaped and sized to hold the bottom of the container 120 which has a rounded end; however, it should be understood that the holder 132 can instead be configured to hold a container 120 that has a different shape.
[0070] In some embodiments, as shown in figures 1 to 5, support 132 can be movable (for example, longitudinally) in compartment 102, for example, in response to the second portion 106 of compartment 102 which is moved from its first position 148 for its second position 150. That is, as shown in figures 2 and 3, the support 132 can include a first position (for example, a first longitudinal position) in which the container 120 is not fractured, and a second position (for example, example, a second longitudinal position) in which the container 120 is fractured. The first position of the support 132 can correspond to the first position 148 of the second portion 106 of the compartment 102, and the second portion of the support 132 can correspond to the second position 150 of the second portion 106 of the compartment 102.
[0071] At least a portion of the arms 142 can be formed of a flexible material, so that the arms 142 can move or flex, for example, in response to the support 132 being moved in compartment 102. For For example, in the embodiment illustrated in figures 1 to 5, at least a portion of compartment 102 (for example, the first portion 104) can include a tapered portion 146 in which compartment 102 (for example, at least one internal surface of wall 108 ) generally tapers in the longitudinal direction D1. As a result, the cross-sectional area in compartment 102 can generally decrease along the longitudinal direction D1. In the embodiment illustrated in figures 1 to 4, the tapered portion 146 is shown as a result of the entire tapering wall 108. However, it should be understood that the internal dimensions of compartment 102 can generally decrease in the tapered portion along the longitudinal direction D1 without changing the external dimensions of compartment 102. In some embodiments, the outer dimensions of compartment 102 may be uniform throughout its length, even though the inner portion of compartment 102 tapers along its length.
[0072] In the embodiment illustrated in figures 1 to 5, as the second portion 106 of compartment 102 is moved from the first position 148 (see figure 2) to the second position 150 (see figure 3), the second portion 106 contacts (for example, directly or indirectly) container 120, causing container 120 to move longitudinally downward in the tapered portion 146 of compartment 102, for example, because of connector 134 of insert 130. As the container 120 is moved in compartment 102, the cross-sectional area available for support 132 and container 120 decreases, causing arms 142 of support 132 to squeeze container 120 and impact an external surface of container 120.
[0073] In some embodiments, as shown in figure 5, the insert 130 may further include one or more ribs or projections 158 positioned to concentrate the crushing force to increase the pressure on the container 120 in the regions adjacent to the projections 158, and to facilitate fracturing of container 120 more easily and in one or more desired regions. The projections 158 can also function at least partially to hold a portion of the container 120, and the projections 158 can reduce the total effort or force required to move the second portion 106 between the first position 148 and the second position 150, and to fracture the container 120 (or a portion thereof).
[0074] In some embodiments, the arms 142 of the insert 130 may be movable inward / outward (for example, radially inward / outward) relative to the outer surface of the container 120, for example, in response to movement of the support 132 longitudinally in the compartment 102 in response to the movement of the second portion 106 of the compartment 102 between its first position 148 and its second position 150. This flexibility in the arms 142 can facilitate the tightening or crushing of the container 120. In some embodiments, as shown in figure 5, one or more of the arms 142 can include an external protrusion 162 positioned in contact with an internal surface of the wall 108 (or of the first portion 104 of the compartment 102) and act as a cam along the surface as the second portion 106 of compartment 102 is moved between the first position 148 and the second position 150. This cam action can also control and facilitate the movement of the container 120 n the compartment and / or fracture of the container 120. In some embodiments, the first position of one or more of the arms 142 (and the projections 158) may correspond to the first position 148 of the second portion 106 of compartment 102 (and / or the first position support 132). In addition, in some embodiments, the second position of one or more of the arms 142 (and the projections 158) may correspond to the second position 150 of the second portion 106 of compartment 102 (and / or the second position of the support 132).
[0075] As shown in figures 2 and 3, the arms 142 (and anything attached to the arms 142, such as the projections 158) can be moved radially towards, and away from, the outer surface of the container 120, between a first position (for example, a first radial position) in which the projections 158 are not fracturing, or possibly not even contacting, the container 120, and a second position (for example, a second radial position) in which the projections 158 are fracturing the container 120.
[0076] In some embodiments, at least a portion of the insert 130 may be or include an "opener", and may be adapted to break or open the container 120 to release liquid 122. For example, in some embodiments, the projections 158 (or projections 158 in combination with another portion of insertion element 130, such as support 132 and / or arms 142) can be called the "opener" of the sterilization biological indicator 100.
[0077] As shown in figures 1 to 5, and particularly, in figure 5, the support 132 is configured to hold a bottom portion of the container 120, and the arms 142 and projections 158 are positioned to fracture the container 120 in one location near the bottom of the container 120 as it is positioned in the compartment 102. This configuration can allow the container 120 to break close to its bottom and can facilitate the removal of the liquid 122 from the container 120, which can improve the availability of the liquid 122 for spores 115, and can improve the reliability of release of liquid 122 in fluid communication with spores 115 (for example, with spore reservoir 136). This configuration is shown only as an example, however, it should be understood that the arms 142 can be shorter or longer than the one illustrated and the projections 158 can be positioned higher or lower than the one illustrated to fracture the container 120 in any way desired.
[0078] In some embodiments, the insert 130 does not include the ribs or projections 158 positioned to concentrate the crushing force on the container 120, but instead, the arms 142 themselves tighten and fracture the container 120 as the second portion 106 is moved from first position 148 to second position 150. Container 120 is shown as an oblong capsule or ampoule with two hemispherical or radiated ends connected by flat and substantially straight side walls. In these container embodiments, the arms 142 (whether the arms 142 include the projections 158 or not), as shown in figures 1 to 5, can be configured to extend sufficiently spaced around one end of the container 120 so as to that the arms 142 are positioned to fracture the container 120 in a position on its flat wall, where the container 120 may be weaker. For example, arms 142 and / or projections 158 can be configured to contact container 120 in a direction that is substantially perpendicular to the flat side of container 120. These modalities can reduce the breaking force as a whole (and the breaking force). activation) required to fracture container 120. The oblong capsule-shaped container 120 is shown by way of example only, however, it should be understood that a variety of container configurations can be employed, and the insert 130 and the support 132 can be configured to operate with any container format. In some embodiments, support 132 can be configured to fracture container 120 at a radiated end. For example, the modalities illustrated in figures 6 to 7, 8 to 9, 10 to 13 and 14 to 17 each include insertion elements (and supports) adapted to fracture a container at a radiated end.
[0079] In some embodiments, the base 144 of the support 132 can be configured to facilitate the movement of the liquid 122 to the spores 115 after the container 120 has been fractured. For example, in some embodiments, base 144 may include an opening or most of the base may include an opening that is positioned to facilitate movement of liquid 122 beyond support 132 after container 120 has been fractured.
[0080] In some embodiments, as shown in figure 2, the insert 130 can be sized and shaped to allow the container 120 to be kept out of the tapered position 146 of compartment 102 during sterilization and before activation to inhibit activation accidental or premature sterilization biological indicator 100. This setting can also inhibit inadvertent rupture due to shock or expansion of the material (for example, due to exposure to heat during a sterilization process).
[0081] In the embodiment illustrated in figures 1 to 5, the insert 130 includes three arms 142 which are equally spaced circumferentially around the container 120. However, this need not be the only case. In some embodiments, an arm 142 is sufficient both to hold the container 120 prior to activation and to fracture the container 120 as the second portion 106 of compartment 102 is moved to the second position 150. In some embodiments, a combination of elements in the insertion element 130 and the elements in the compartment 102 (for example, in the wall 108 of the first portion 104) can be used to maintain and / or fracture the container 120.
[0082] As shown in figures 2 and 4, if the insert 130 includes one or more arms 142, the arms 142 (for example, themselves or in combination with a portion of compartment 102) can be configured to hold the container 120 in compartment 102 in a consistent location to provide a substantially constant sterilizing path 164 during sterilization. For example, instead of allowing the container 120 to move or reach (for example, radially and / or longitudinally) in compartment 102 before activation (for example, during sterilization), the insert 130 can hold the container 120 in a substantially consistent position, which allows a sterilizer to have a substantially consistent and relatively unobstructed path between an outer surface of compartment 120 and an inner surface of compartment 102, with little or no opportunity for inadvertent blocking.
[0083] As shown in figure 4, the arms 142 do not need to be exactly of equal shape or size and can be dimensioned and positioned to control the trajectory of sterilizer 164, for example, to adjust the death / survival rate of the biological indicator of sterilization 100, to inhibit inadvertent fracture of container 120, to facilitate movement of container 120 in compartment 120, to join with or engage with compartment 102, and / or to control rupture of container 120.
[0084] As shown in figure 2, in the first position 148, the container 120 can be kept intact in a position separate from the lower portion 114 or the spore reservoir 136, and the liquid 122 can be contained within the container 120. In addition , in the first position 148, as shown in figure 4, the insertion element 130, and particularly the support 132, can be used to hold the container 120 in a position in the compartment 102 in which a minimum area in minimum cross-section of space between the container 120 and the compartment 102 and / or between the container 120 and any other structures or components positioned in the compartment 102 (for example, at least a portion of the insert 130, such as the support 132, etc.) is maintained.
[0085] In some cases, without the provision of the means to maintain at least a minimum spacing around the container 120 (for example, between the container 120 and the surrounding structure), there may be a possibility that the container 120 will be positioned in the compartment 102 (for example, in the tapered portion 146) so that it obstructs or blocks the sterilizing path 164. However, the biological sterilization indicator 100 of the present description is designed to prevent this from occurring. For example, in the embodiment illustrated in figures 1 to 5, the insert 130 (and particularly the support 132) can be configured to keep the container 120 out of the tapered position 146 of the compartment 102, so that at least a minimum area of cross section is maintained around the container 120 in any orientation of the sterilization biological indicator 100 prior to activation. For example, in the embodiment illustrated in figures 1 to 5, even if the biological sterilization indicator 100 is turned upside down, the container 120 can abandon contact with the insert 130, but in no orientation, the container 120 is moved closer to the tapered portion 146, or the spores 115 until activation of the biological sterilization indicator 100. In addition, until activation, at least a minimum spacing (and particularly, a cross-sectional area of that spacing) between the container 120 and the compartment 102 and / or the insert 130 can be maintained to provide a substantially constant sterilizing path 164, for example, around the container 120.
[0086] In some embodiments, the sizing and relative positioning of the components of the biological sterilization indicator 100 can be configured so that, prior to activation, the container 120 is kept intact in a location substantially consistent with the biological sterilization indicator 100. This The configuration can provide a substantially constant sterilizing path 164 and can hold the container 120 in a position such that the container 120 is not able to move substantially, or in any way, on the sterilizing biological indicator 100 prior to activation.
[0087] With reference to figures 2, 3 and 5, and as mentioned above, connector 134 can include one or more hinges or folds 135. Connector 134 can also include one or more sections 137 adjacent to hinge 135 that can be movable towards, or distant from each other (for example, open or flat) as hinge 135 is opened or closed. As shown in figure 2, before activation, hinge 135 can be relatively open or expanded, so that sections 137 adjacent to hinge 135 are separated in a first quantity. As shown in figure 3, after activation, hinge 135 can be relatively closed or flattened, so that sections 137 adjacent to hinge 135 are separated into a second quantity, less than the first. That is, as shown in figure 2, before activation, connector 134 can be a first configuration, and, as shown in figure 3, after activation, connector 134 can have a second configuration.
[0088] As shown further in figure 3, in the second configuration of connector 134, sections 137 of connector 134 can be flattened on top of each other and can be positioned to substantially block or close opening 117 between an upper portion 116 and a portion bottom 114 of compartment 102. This second configuration of connector 134 can prevent the broken portions of container 120 (e.g. fragments) from moving downstream in the biological sterilization indicator 100 in the bottom 114 of compartment 102 where the portions of container 120 may interfere with spore growth and / or detection of spore growth. As shown in figure 3, base 144 of support 132 can also collect or retain portions of container 120 to prevent those portions from moving downstream in compartment 102.
[0089] In addition, the second configuration of connector 134 can inhibit the diffusion of spores 115 and / or one or more detection signals outside the lower portion 114 of compartment 102, which can improve the detection of any spore growth. For example, in some modalities, spore growth is determined by fluorescent indicators / molecules (for example, fluorophores) or other markers. In some embodiments, if the liquid level after activation of the sterilization biological indicator 100 is above the spore 115 site, these molecules or markers, or the spores 115 themselves, can move or diffuse away or out spore reservoir 136 and potentially out of the lower 114 portion of compartment 102.
[0090] In some embodiments, at least a portion of compartment 102, for example, the lower portion 114 of compartment 102, may be transparent to a wavelength of electromagnetic radiation or a wavelength range (for example, when they are employed optical detection methods), which can facilitate the detection of spore growth. That is, in some embodiments, at least a portion of compartment 102 may include or form a detection window 167.
[0091] In addition, in some embodiments, as shown in figures 1 to 5, at least a portion of compartment 102, for example, the lower portion 114 may include one or more planar walls 168. These planar walls 168 can facilitate detection , (for example, optical detection) of spore growth. In addition, in the embodiment illustrated in figures 1 to 5, wall 108 of the first portion 104 of compartment 102 may include one or more skipped regions, such as step 152 described above and a tapered wall or step 170. The tapered wall 170 can function to reduce the total thickness and size of the lower portion, or detection portion, 114 of compartment 102, which can facilitate detection. In addition, the fact that there are one or more steps and / or tapered walls 152 and 170 may allow the biological sterilization indicator 100 to be coupled to a reader or detection device in only one orientation, so that the biological sterilization indicator 100 is "linked" to the reader, which can minimize user error and improve the reliability of a detection process.
[0092] Just as an example, the insert 130 shown in figures 1 to 5 is shown to be a unitary device that includes at least the following: means for holding the container 120 before activation, for fracturing the container 120 during activation; to allow movement of the container 120 in the compartment 102; to provide a substantially constant sterilizing path 164, to provide a spore reservoir 136; to collect and / or retain portions of the fractured container 120 after activation (or at least partially inhibit movement of the portions of the fractured container 120 in the lower portion 114 of compartment 102); and / or to minimize the diffusion of spores 115 and / or signals from the lower portion 114 to the upper portion 116 of compartment 102 after activation. However, it should be understood that in some embodiments, the insert 130 may include multiple portions that may not be part of a single unitary device, and each portion may be adapted to perform one or more of the above functions.
[0093] The unitary configuration of the insertion element 130 can also facilitate the movement of the container 120 in the compartment 102. For example, because the insertion element 130 extends from a place where it supports the container 120 until the end of the base of the reservoir 103 in the compartment 102, the bottom of the insert 130 can press against a base 169 of the compartment 102 as the second portion 106 is moved from the first position 148 to the second position 150. By allowing the insert 130 extend to the end of the base 169 of the compartment 102, a necessary strength and force can be obtained to allow the support 132 (and the container 120) to move in the compartment 102 in relation to the spore reservoir 136 and the lower portion 114 compartment 102, and / or fracture compartment 120. However, it must be understood that other configurations are possible and can be used. For example, in some embodiments, such as the embodiment illustrated in figures 10 to 13 and described below, the insert 130 can be configured to be in a position bordering the partition wall 118 to provide the strength and resistance necessary to fracture the container 120 .
[0094] In addition, the insertion element 130 is called an "insertion element" because in the embodiment illustrated in figures 1 to 5, the device that performs the above functions is a device that can be inserted in the reservoir 103 of compartment 102. However, it should be understood that the insert 130 may instead be provided by compartment 102 itself or another component of the biological sterilization indicator 100 and may not necessarily be insertable in compartment 102. The term "insert element "will be described throughout this description for the sake of simplicity, but it should be understood that this term is not intended to limit, and it should be considered that other equivalent structures that perform one or more of the above functions can be used instead , or in combination with, the insert 130. In addition, in the embodiment illustrated in figures 1 to 5, the insert 130 is liable to be inserted into, and removable from, compartment 102, and particularly, in and out of the first portion 104 of compartment 102. However, it should be understood that even if insertion element 130 is insertable in compartment 102, insertion element 130 may not be removable from the compartment 102, but can instead be fixedly coupled to compartment 102, in a way that inhibits the removal of insertion element 130 from compartment 102 after positioning insertion element 130 in a desired location.
[0095] The biological sterilization indicator of the present description generally keeps the liquid 122 and the spores 115 separated but in relatively close proximity (for example, within the biological sterilization indicator 100 one-piece) during sterilization, so that the liquid 122 and spores 115 can be readily combined after exposure to a sterilization process. The liquid 122 and the spores 115 can be incubated during a detection process, or the sterilization biological indicator 100 can be incubated previously for a detection process. In some embodiments, during the incubation of the spores with the liquid 122, an incubation temperature above room temperature can be used. For example, in some embodiments, the incubation temperature is at least about 37 ° C, in some embodiments, the incubation temperature is at least about 50 ° C (for example, 56 ° C), and in some embodiments, at least about 60 ° C. In some embodiments, the incubation temperature is not greater than about 60 ° C, in some embodiments, not greater than about 50 ° C, and in some embodiments, not greater than about 40 ° C.
[0096] A detection process can be adapted to detect a detectable spore change (for example, from inside the spore reservoir 136). That is, a detection process can be adapted to detect a variety of characteristics, including, but not limited to, electromagnetic radiation (for example, in the bands of ultraviolet, visible, and / or infrared light), fluorescence, luminescence, dispersion light, electronic properties (for example, conductance, impedance, or the like, or combinations thereof), turbidity, absorption, Raman spectroscopy, ellipsometry, or the like, or a combination thereof. The detection of these characteristics can be performed by one or more of a fluorimeter, spectrophotometer, colorimeter, or similar, or combinations thereof. In some modalities, such as those that measure fluorescence, visible light, etc., the detectable change is measured by detection at a particular wavelength.
[0097] Spores and / or liquid 122 can be adapted (for example, labeled) to produce one or more of the following characteristics as a result of a biochemical reaction that is a sign of spore viability. As a result, no detectable change (for example, when compared to a baseline or antecedent reading) can mean an effective sterilization process, while a detectable change can mean an ineffective sterilization process. In some embodiments, the detectable change may include a rate at which one or more of the above characteristics are being changed (for example, increased fluorescence, decreased turbidity, etc.).
[0098] In some modalities, the viability of spores can be determined by exploiting the enzymatic activity. As described in Matner et al., US Patent No. 5,073,488, entitled "Rapid Method for Determining Efficacy of a Sterilization Cycle and Rapid Read-out Biological Indicator", which is incorporated here by way of reference, enzymes can be identified for a particular type of spore in which the enzyme has particularly useful characteristics that can be exploited to determine the effectiveness of a sterilization process. These characteristics may include the following: (1) the enzyme, when subjected to sterilization conditions that would be sufficient to decrease a population of 1 X 106 test microorganisms in about 6 records (that is, to a population of about zero when measured by the lack of flowering of microorganisms), has a residual activity that is equal to the "antecedent" as measured by the reaction with a substrate system for the enzyme; and (2) the enzyme, when subjected to sufficient sterilization conditions just to decrease the population of 1 X 106 test microorganisms in at least 1 record, but less than 6 records, has greater enzyme activity than the "antecedent" as measured by reaction with the enzyme substrate system. The enzyme substrate system can include a substance, or mixture of substances, that is influenced by the enzyme to produce a product modified by a detectable enzyme, as evidenced by a detectable change.
[0099] In some embodiments, the biological sterilization indicator 100 can be tested in a unilateral mode, in which the biological sterilization indicator 100 includes only a detection window (for example, detection window 167 of figure 1) that is positioned , for example, next to spores 115. In some embodiments, however, the biological sterilization indicator 100 may include more than one detection window (for example, a window formed by all or a portion of both parallel walls 168 of the lower portion 114 of compartment 102), so that the sterilization biological indicator 100 can be tested through more than one detection window. In modalities that employ multiple detection windows, the detection windows can be positioned side by side (similar to the one-sided mode), or the detection windows can be oriented at an angle (for example, 90 degrees, 180 degrees, etc.) in relation to each other.
[0100] In general, spores 115 are positioned inside spore reservoir 136 which is in fluid communication with reservoir 103. In some embodiments, spore reservoir 136 forms a portion of reservoir 103. As shown in figure 2, the reservoir 103 is in fluid communication with the environment (for example, through opening 107) during sterilization to allow the sterilizer to enter reservoir 103 during the sterilization process to sterilize spores 115. Container 120 can be configured to contain the liquid 122 during sterilization to inhibit fluid communication of liquid 122 with spores 115, reservoir 103, and sterilizer during sterilization.
[0101] In some embodiments, the spores 115 can be positioned in a spore location or in a plurality of spore locations, all of which can be positioned in reservoir 103, in the lower 114 portion of compartment 102, and / or in the reservoir of spores 136. In some embodiments, the fact that there are multiple spore sites can maximize spore exposure to sterilizer and liquid 122, can optimize preparation (for example, spore disposition can be facilitated by placing each spore site in a depression within the biological sterilization indicator 100), and can optimize the detection characteristics (for example, due to the fact that spores may not be so easily detected in the middle of a large spore site). In embodiments employing a plurality of spore sites, each spore site may include a different known number of spores, and / or each spore site may include different spores, so that a plurality of types of spores can be tested. When employing multiple types of spores, the biological sterilization indicator 100 can be used for a variety of sterilization processes and a specific spore location can be analyzed for a specific sterilization process, or multiple types of spores can be used to test additionally the effectiveness, or reliability, of a sterilization process.
[0102] In addition, in some embodiments, the biological sterilization indicator 100 may include a plurality of spore reservoirs 136, and each spore reservoir 136 may include one or more spore sites 115. In some embodiments, the use of a plurality of spore reservoirs 136, the plurality of spore reservoirs 136 can be positioned in fluid communication with reservoir 103.
[0103] In some embodiments, the spores 115 can be covered with a cover (not shown) adapted to fit in, or over, the spore reservoir 136. This cover can help to keep the spores within a desired region of the biological sterilization indicator 100 during preparation, sterilization and / or use. The cover, if used, can be formed of a material that does not substantially impede a detection process, and / or that is at least partially transmissible to the wavelengths of electromagnetic radiation of interest. In addition, depending on the composition of the covering material, in some embodiments, the covering may facilitate absorption by capillary effect of the liquid 122 (for example, the nutrient medium) next to the spores 115. In some embodiments, the covering may also contain features to facilitate the flow of fluids within the spore reservoir 136, such as capillary channels, hydrophilic microporous fibers or membranes, or the like, or a combination thereof. In addition, in some embodiments, coverage can isolate a signal, or improve the signal, which can facilitate detection. This cover can be used if the spores 115 are positioned inside the spore reservoir 136 or directly in the lower portion 114 of compartment 102. Furthermore, this cover can be used in modalities that employ a plurality of spore sites. The cover can include a variety of materials, including, but not limited to, paper, a polymer (for example, any of the polymers mentioned above in relation to compartment 102), an adhesive (for example, acrylate, natural or synthetic rubber , silicone, silicone polyurea, isocyanate, epoxy, or combinations thereof), a woven cloth, a non-woven cloth, a microporous material (for example, a microporous polymeric material), a glass, a porcelain, a ceramic, a material gel former (for example, guar gum), or combinations thereof.
[0104] In some embodiments, the biological sterilization indicator 100 may also include a modified inner surface, such as a reflective surface, a white surface, a black surface, or other suitable surface modification to optimize the optical properties of the surface. A reflective surface (for example, provided by a foil) can be positioned to reflect a signal sent to the spore reservoir 136 from a test or detection device and / or to reflect any signal generated within the spore reservoir 136 back to the test device. As a result, the reflective surface can work to optimize (for example, optimize the intensity of) a signal from the sterilization biological indicator 100. This reflective surface can be provided by an internal surface of compartment 102; a material coupled to the internal surface of compartment 102; an internal surface of the spore reservoir 136; a material coupled to the internal surface of the spore reservoir 136, or the like; or the reflective surface can form a portion of or be coupled to a spore substrate; or a combination of them.
[0105] Similarly, in some embodiments, the biological sterilization indicator 100 may also include a white and / or black surface positioned to increase and / or decrease a particular signal sent to the spore reservoir 136 from a device test and / or increase and / or decrease a particular signal generated within the spore reservoir 136. As an example only, a white surface can be used to improve the signal, and a black surface can be used to reduce the signal ( that is, noise).
[0106] In some embodiments, the spores 115 can be positioned on a functionalized surface to promote immobilization of the spores 115 on the desired surface. For example, this functionalized surface can be provided by an internal surface of compartment 102, it can be provided by an internal surface of spore reservoir 136, it can form a portion of or if coupled to a spore substrate, or the like, or a combination of the same.
[0107] In some embodiments, the 115 spores are positioned (for example, applied by coating or an application method) on a microstructured or micro-applied surface (for example, as the microstructured surfaces presented in Halverson et al., PCT publication no. WO 2007/070310, Hanschen et al., US publication No. 2003/0235677, and Graham et al., PCT publication No. WO 2004/000569, all of which are incorporated herein by reference). For example, such a microstructured surface can be provided by an internal surface of compartment 102, an internal surface of spore reservoir 136, and form a portion of, or coupled with, a spore substrate, or the like, or a combination thereof.
[0108] In some embodiments, the biological sterilization indicator 100 may further include a gel-forming material positioned to be combined with spores 115 and liquid 122 when liquid 122 is released from container 120. For example, the material gel former can be positioned close to spores 115 (for example, in spore reservoir 136), in the lower portion 114 of compartment 102, it can form a portion to be coupled to a spore substrate, or the like, or a combination thereof . Such a gel-forming material can form a gel (e.g., a hydrogel) or a matrix comprising spores and nutrients when the liquid 122 comes in contact with the spores. A gel-forming material (for example, guar gum) can be particularly useful because it has the ability to form a gel upon hydration, and can assist in locating a signal (for example, fluorescence), can anchor spores 115 in place , can help to minimize spore diffusion 115 and / or a signal from spore reservoir 136, and can improve detection.
[0109] In some embodiments, the biological sterilization indicator 100 may also include an absorbent or material for absorption by capillary effect. For example, the material for absorption by capillary effect can be positioned close to spores 115 (for example, in spore reservoir 136), can form at least a portion of, or be coupled to, a spore substrate, or the like, or combination thereof. This capillary absorption material includes a porous capillary absorption block, an immersion block, or the like, or a combination thereof, to facilitate placing the liquid 122 in close contact with the spores.
[0110] In some embodiments, the frangible container 120 can be configured to facilitate fracturing of the frangible container 120 in the desired manner. For example, in some embodiments, a lower portion of the frangible container 120 may be formed of a thinner and / or weaker material, so that the lower portion fractures, preferably, in another portion of the frangible container 120. In addition , in some embodiments, the frangible container 120 may include a variety of features positioned to facilitate fracturing of the frangible container 120 in a desired manner, including, but not limited to, a thin and / or weakened area, a cut line, perforation, or the like, or combinations thereof.
[0111] As a result, the frangible container 120 may have a first closed state in which liquid 122 is contained within frangible container 120 and a second open state in which frangible container 120 has been fractured and liquid 122 is released into reservoir 103 and / or spore reservoir 136, and in contact with spores 115.
[0112] In some embodiments, the biological sterilization indicator 100 can be activated (for example, the second portion 106 can be moved to the second position 150) manually. In some embodiments, the biological sterilization indicator 100 can be activated by a reader or test device (for example, by positioning the biological sterilization indicator 100 on the reader or test device). In some embodiments, the biological sterilization indicator 100 can be activated by a device independent of the test device or reader (for example, by positioning the biological sterilization indicator 100 on the device). In some embodiments, the biological sterilization indicator 100 can be activated by a combination of two or more of the test device, a device independent of the test device, and manual activation.
[0113] One or both, the biological sterilization indicator 100 and another device, such as a test device, can be additionally configured to inhibit premature or accidental fracture of the frangible container 120. For example, in some embodiments, the biological indicator of sterilization 100 may include a lock or locking mechanism that is positioned to prevent the second portion 106 of compartment 102 from moving to the second position 150 as far as desired. In these modalities, the biological sterilization indicator 100 cannot be activated until the lock is moved, removed or unlocked. In addition, or alternatively, in some embodiments, the biological sterilization indicator 100 may include a lock or locking mechanism that is positioned to prevent the second portion 106 of compartment 102 from moving from the second position 150 back to the first position 148 after activation.
[0114] In some embodiments, reservoir 103 has a volume of at least about 0.5 millimeters (mL), in some embodiments, at least about 1 mL, and in some embodiments, at least about 1.5 mL . In some embodiments, reservoir 103 has a volume not greater than about 5 mL, in some embodiments not greater than about 3 mL, and in some embodiments, not greater than about 2 mL.
[0115] In some embodiments, the spore growth chamber 114 (i.e., the lower portion 114 of the first portion 104 of compartment 102) has a volume of at least 5 microliters, in some embodiments at least about 20 microliters, and in some embodiments, at least about 35 microliters. In some embodiments, the spore growth chamber 114 has a volume of no more than about 250 microliters, in some embodiments, no greater than about 175 microliters, and in some embodiments, no greater than about 100 microliters.
[0116] In some embodiments, the spore reservoir 136 has a volume of at least about 1 microliter, in some embodiments at least about 5 microliters, and in some embodiments, at least about 10 microliters. In some embodiments, the spore reservoir 136 has a volume no greater than about 250 microliters, in some embodiments no greater than about 175 microliters, and in some embodiments, no greater than about 100 microliters.
[0117] In some embodiments, the frangible container 120 has a volume of at least about 0.25 mL, in some embodiments, at least about 0.5 mL, and in some embodiments, at least about 1 mL. In some embodiments, the frangible container 120 has a volume of no more than about 5 ml, in some embodiments, no more than about 3 ml, and in some embodiments, no more than about 2 ml.
[0118] In some embodiments, the volume of liquid 122 contained in the frangible container 120 is at least about 50 microliters, in some embodiments at least about 75 microliters, and in some embodiments at least about 100 microliters. In some embodiments, the volume of liquid 122 contained in the frangible container 120 is no greater than about 5 mL, in some embodiments no greater than about 3 mL, and in some embodiments, no greater than about 2 mL.
[0119] In some embodiments, as shown in figures 1 to 4, at least a portion of the compartment can be flat (for example, the parallel walls 168), and can be substantially planar in relation to the spore reservoir 136, and one or both of the parallel walls 168 or a portion thereof (for example, the detection window 167) substantially match at least one dimension of the spore reservoir 136 and / or the location of the spores 115. In other words, the wall 168 or a portion thereof (for example, the detection window 167) may include a cross-sectional view that is substantially the same size as the cross-sectional area of the spore reservoir 136 and / or the spore location 115. This Equal size testing between wall 168 / detection window 167 and spore reservoir 136 and / or spore site 115 can maximize the signal detected during a detection or testing process. Alternatively, or in addition, the wall 168 or detection window 167 can be dimensioned to match the reservoir 103 (for example, at least one dimension or the cross-sectional areas can be dimensioned to be equalized). This equal size test between the detection zones can improve the spore detection test.
[0120] The biological sterilization indicator 100 shown in figures 1 to 4, at least the portion of the biological sterilization indicator 100 where the spores 115 are positioned, is relatively thin (ie, the "z dimension" is minimized), so that the optical path of the spores to the wall 168 (or detection window 167) is minimized and / or any effect of interference of substances in the liquid 122 (or nutrient medium) is minimized.
[0121] In use, the biological sterilization indicator 100 can be placed together with a sterilization batch during a sterilization process. During sterilization, a sterilizer is in fluid communication with the reservoir 103, with the spore reservoir 136, and with the spores 115 mainly via the sterilizing path 164, so that the sterilizer can reach the spores to produce sterile spores. In addition, during sterilization, the frangible container 120 is in a closed state where the liquid 122 is protected from the sterilizer and is not in fluid communication with reservoir 103, with spore reservoir 136, with spores 115, or with the trajectory of sterilizer 164.
[0122] After sterilization, the effectiveness of the sterilization process can be determined using the biological sterilization indicator 100. The second portion 106 of compartment 102 can be unlocked, if previously locked in the first position 148, and moved from the first position 148 to the second position 150. This movement of the second portion 106 can cause the connector 134 of the insert 130 to flex in the hinge 135, which can cause the angle between the adjacent sections 137 of the connector 134 to decrease, which can shorten the length of the connector 134 (and the insert 130) to allow the frangible container 120 to move in compartment 102, for example, along the longitudinal direction D1 of compartment 102. Frangible container 120 can then be forced to contact the projections 158 of the insert 130 to fracture the frangible container 120. Fracture of the frangible container 120 can change the container f rangeable 120 from its closed state to its open state and release liquid 122 in reservoir 103, and in liquid communication with spore reservoir 136 and spores 115. Liquid 122 may include a nutrient medium (for example, germination medium ) for spores, or liquid 122 may contact the nutrient medium in a dry form (for example, in a powdered or tablet form) to form the nutrient medium, so that the mixture that includes the sterile spores and the nutrient medium is formed. The mixture can then be incubated before or during the testing process, and the biological sterilization indicator 100 can be interrogated for signs of spore growth.
[0123] To detect a detectable change in spores 115, the sterilization biological indicator 100 can be tested immediately after liquid 122 and after the spores have been combined to achieve a baseline reading. After that, any detectable change in the baseline reading can be detected. The biological sterilization indicator 100 can be monitored and measured continuously or intermittently. In some embodiments, a portion of the incubation step, or the entire incubation step, can be performed before measuring the detectable change. In some embodiments, incubation can be performed at a temperature (for example, 37 ° C, 50-60 ° C, etc.), and the detectable change measurement can be performed at a different temperature (for example, at room temperature, 25 ° C, or 37 ° C).
[0124] The reading time of the biological sterilization indicator 100 (that is, the time to determine the effectiveness of the sterilization process) can be, in some modalities, less than 8 hours, in some modalities less than 1 hour, in some modalities modalities less than 30 minutes, in some modalities less than 15 minutes, in some modalities less than 5 minutes, and in some modalities less than 1 minute.
[0125] Figures 6 to 7 illustrate a biological sterilization indicator 200 according to another embodiment of the present description. The biological sterilization indicator 200 includes many of the elements and features described above with reference to the biological sterilization indicator 100 of figures 1 to 5, except that the biological sterilization indicator 200 includes different means for fracturing the frangible container 220. Consequently, the elements and characteristics that correspond to the elements and characteristics in the illustrated modality of figures 1 to 5 are provided with the same reference numbers in the 200 series. Reference is made to the description above of figures 1 to 5 in the annex for a more complete description of the characteristics and elements (and alternatives for these characteristics and elements) of the modality illustrated in figures 6 and 7.
[0126] The biological sterilization indicator 200 may include a compartment 202, which may include a first portion 204 and a second portion 206 (e.g., a lid) adapted to be coupled together to provide a one-piece biological sterilization indicator. The first portion 204 may include a lower portion 214 and an upper portion 216 separated by a wall 218, in which an opening system 217 can be formed which provides fluid communication between the lower portion 214 and the upper portion 216. Housing 202 may include a reservoir 203 which can be defined by one or both, the first portion 204 and / or the second portion 206 of compartment 202. The biological sterilization indicator 200 may further include spores 215 or a spore site (e.g. , in a spore reservoir 236) positioned in fluid communication with the reservoir 203. The compartment 202 can be defined by at least one liquid impermeable wall, such as a wall 208 of the first portion 204 and / or a wall 210 of the second portion 206.
[0127] As mentioned above, the biological sterilization indicator 200 may also include a frangible container 220 that contains a liquid 222. In some embodiments, only a portion of container 220 is frangible, for example, container 220 may include a frangible cover (for example, a frangible barrier, film, membrane, or similar). Figure 7 shows an upper cross-sectional view of the biological sterilization indicator 200 obtained at a location close to the bottom of the container 220.
[0128] As shown in figures 6 and 7, the biological sterilization indicator 200 can also include an insertion element 230. In some embodiments, the insertion element 230 can be adapted to hold or support the container 220 in order to that container 220 is kept intact in a location separate from spores 215 during sterilization. That is, the insert 230 can include (or function as) a support 232 for the container 220, particularly, before the container 220 is broken during the activation step (i.e., the step in which the liquid 222 is released from the container 220 and introduced into spores 215, which typically occurs after the sterilization process).
[0129] Furthermore, the insert 230 can be adapted to keep the container 220 intact in a position in the compartment 202 that maintains at least a minimum spacing (for example, a minimum area in minimum cross-section of space) between the container 220 and compartment 202 and / or between container 220 and any other components or structures in compartment 202 (for example, at least a portion of the insert 230, such as support 232, etc.), for example, to maintain a sterilizing path 264 substantially constant in the biological sterilization indicator 200. In some embodiments, the insert 230 may be adapted to hold the container 220 in a substantially consistent location in compartment 202.
[0130] In some embodiments, the insert 230 can be further adapted to allow the container 220 to move in compartment 202, for example, longitudinally in relation to compartment 202. This movement can be provided by a flexible connector 234 that includes a live joint or fold 235 and adjacent sections 237. Connector 234 can function in a similar manner to connector 134 of figures 1 to 5.
[0131] In some embodiments, as shown in figure 6, the insert 230 may be additionally adapted to the spore compartment 215. For example, in some embodiments, the insert 230 may include the spore reservoir 236, in which spores 215 can be positioned either directly or on a substrate. In embodiments that employ a nutrient medium that is positioned to be mixed with liquid 222 when it is released from container 220, the nutrient medium can be positioned near or in the spore reservoir 236, and the nutrient medium can be mixed with (for example, dissolved in) water when water is released from container 220.
[0132] As shown in figure 6, during sterilization and before activation, the second portion 206 can be in a first position 248 in relation to the first portion 204. In the first position 248, the container 220 can be kept intact in one position separated from the lower portion 214 or the spore reservoir 236, and the liquid 222 can be contained within the container 220.
[0133] After sterilization, the biological sterilization indicator 200 can be activated to release liquid 222 from container 220 to move liquid 222 to spores 215. That is, the second portion 206 of compartment 202 can be moved to a second position (for example, see position 150 in figure 3 described above) with respect to first portion 204.
[0134] The insertion element 230 will now be described in more detail, with particular reference to figure 6. As shown in figure 6 and mentioned above, in some embodiments, the insertion element 230 may include a support 232. In the embodiment illustrated in figures 6 to 7, support 232 includes three arms 242 and a base 244 similar to those of the embodiment illustrated in figures 1 to 5 and described above. However, in the embodiment illustrated in figures 6 to 7, the biological sterilization indicator 200 includes three arms 242 that are shorter than the arms 142 illustrated in figures 1 to 5 and that do not extend around one end of the container 220 as far as the arms 142 described in figures 1 to 5. In addition, as shown in figures 6 and 7, the arms 242 do not include any projections for fracturing the container 220. Instead, compartment 202 includes three projections or ribs 258 that extend into wall 208, and which are positioned to fracture container 220 as container 220 is moved (for example, longitudinally downwards) in compartment 202 as the second portion 206 is moved relative to the first portion 204.
[0135] In some embodiments, the support 232 does not need to include the arms 242, but instead it can only include the base 244. In these embodiments, the base 244 can be smaller than one end of the container 220, to provide adequate space for the around container 220 for a sterilizer to reach spores 215 during sterilization.
[0136] As shown in figures 6 and 7, however, arms 242 provide support for container 220 prior to activation while also providing adequate space between adjacent arms 242 during a substantially constant path of sterilizer 264 in compartment 202. A potential advantage that the support 232 can have on the support 132 of figures 1 to 5 consists of the fact that the support 232 can provide additional space around the container 220 for the sterilizer to move towards the spores 215 during sterilization.
[0137] Furthermore, in the embodiment illustrated in figures 6 and 7, the insert 230 includes three arms 242 which are equally spaced circumferentially around the container 220. However, this need not be the case. In some embodiments, an arm 242, or base 244 alone, is sufficient to hold the container 220 before activation. As shown in figures 6 and 7, if support 232 includes arms 242, support 232 can be configured to hold container 220 in compartment 202 in a substantially consistent location to provide a substantially consistent sterilizing path 264 during sterilization.
[0138] In some embodiments, the projections 258 may include one or more edges (for example, tapered edges) or points or be otherwise configured to concentrate the crushing force to increase the pressure on the container 220 in the regions adjacent to the projections 258, and to facilitate fracturing of container 220 more easily in one or more desired regions. In some embodiments, the projections 258 (for example, an upper end 259 of the projections 258) can also function at least partially to hold a portion of the container 220, and the projections 258 can reduce the total effort or force required to move the second portion 206 in relation to the first portion 204 and to fracture the container 220 (or a portion thereof). As shown in figure 6, in some embodiments, the projections 258 can be positioned to fracture the container 220 at its radiated end, for example, when an oblong or capsule-shaped container 220 is employed.
[0139] As shown in figures 6 and 7, projections 258 are formed integrally with wall 208 of compartment 202. However, it should be understood that this need not be the case. Projections 258 can be formed separately from compartment 202 and coupled to compartment 202, or projections 258 can be provided by an additional insert. In these embodiments, the projections 258 can consist of a separate insertion element, or multiple projections 258 can be provided by one or more insertion elements. In addition, these insertion elements can be configured to be in a position bordering wall 218 to inhibit movement of that insertion element in the vicinity of spores 215 (for example, in the lower portion 214 of compartment 202).
[0140] In addition, in some embodiments, as shown in figure 6, the projections 258 can extend a certain distance in the compartment 202 along the longitudinal direction D2, and the length of the projections 258 can be adjusted to control the fracture of container 220 in a desired position in compartment 202 and in a desired manner. The configuration of the 258 projections is shown in figures 6 and 7 for example only.
[0141] In addition, the biological sterilization indicator 200 is shown in figures 6 and 7 as including three projections 258 for example only, but it should be understood that only one and as many as possible or structurally necessary can be used. In addition, the biological sterilization indicator 200 is shown to have a line of symmetry, where a projection 258 (the upper projection 258 when seen in figure 7) is wider and shorter than the other identical projections 258. However, understand that the projections 258 can be shaped and sized as desired, depending on the shape and dimensions of the compartment 202, and in the desired way and position to fracture the container 220.
[0142] In some embodiments, as shown in figure 6, at least a portion of compartment 202 may include a tapered portion 246 in which compartment 202 (for example, wall 208) generally tapers in the longitudinal direction D2 of the compartment 202. As a result, the cross-sectional area in compartment 202 can, in general, decrease along the longitudinal direction D2. In some embodiments, the projections 258 alone may vary in thickness (that is, towards the container 220, for example, in a radial direction) along the longitudinal direction D2, so that the cross-sectional area available for the container 220 in general it decreases as the container 220 is moved in the compartment 202 during activation, even though the external dimension of the compartment 202 may not change.
[0143] In some embodiments, the arms 242 of the insert 230 can be movable inward / outward (i.e., radially inward / outward) in relation to the outer surface of the container 220. This flexibility in the arms 242 can facilitate the squeezing or crushing of the container 220, for example, in combination with the projections 258.
[0144] In some embodiments, as shown in figure 2, the insertion element 230 can be sized and shaped to allow the container 220 to be kept above the projections 258 and outside the tapered portion 246 of compartment 202 (or outside the most between projections 258) during sterilization and before activation to inhibit accidental or premature activation of the biological sterilization indicator 200. This setting can also inhibit inadvertent rupture due to shock or material expansion (for example, due to exposure to heat during the sterilization process). During activation, however, the support 232 can be moved (for example, longitudinally) in relation to the projections 258 (and to the compartment 202), for example, towards the spore reservoir 236.
[0145] As shown in figure 6, support 232 is configured to hold a bottom portion of container 220, and projections 258 are positioned to fracture container 220 at a location close to the bottom of container 220 as it is positioned in compartment 202. This configuration can allow container 220 to be ruptured close to its bottom and can facilitate the removal of liquid 222 from container 220, which can improve the availability of liquid 222 to spores 215, and can improve the reliability of the release of liquid 222 in fluid communication with spores 215 (for example, with spore reservoir 236). This configuration is shown by way of example only, however, it should be understood that the projections 258 can be configured and positioned to fracture the container 220 in any desired manner.
[0146] Just as an example, the insert 230 shown in figures 6 and 7 is shown as a unitary device that includes at least the following: means for holding the container 220 before activation; to allow movement of container 220 in compartment 202; to provide a substantially constant sterilizing path 264; to provide a spore reservoir 236; to collect and / or retain portions of the fractured container 220 after activation (or at least partially inhibit movement of portions of the fractured container 220 in the lower portion 214 of compartment 202); and / or to minimize the diffusion of spores 215 and / or signals from the lower portion 214 to the upper portion 216 of compartment 202 after activation. However, it should be understood that in some embodiments, the insert 230 may include multiple portions that may not be part of a simple, unitary device, and each portion may be adapted to perform one or more of the above functions.
[0147] In use, the biological sterilization indicator 200 can be placed together with the sterilizing batch for a sterilization process. During sterilization, the sterilizing path 264 is in fluid communication with the reservoir 203, with the spore reservoir 236, and with the spores 215, so that the sterilizer can reach the spores to produce sterile spores. In addition, during sterilization, the frangible container 220 is in a closed state in which liquid 222 is protected from the sterilizer and is not in fluid communication with reservoir 203, with spore reservoir 236, with spores 215, or with the trajectory of sterilizer 264.
[0148] After sterilization, the effectiveness of the sterilization process can be determined using the biological sterilization indicator 200. The second portion 206 of compartment 202 can be unlocked, if previously locked in the first position 248, and moved from the first position 248 for a second position. This movement of the second portion 206 may cause the connector 234 of the insert 230 to flex in the hinge 235, which may cause the angle between adjacent sections 237 of the connector 234 to decrease, which may shorten the length of the connector. 234 (and the insert 230) to allow the frangible container 220 to move in the compartment 202, for example, along the longitudinal direction D2 of the compartment 202. The frangible container 220 can then be forced to come into contact with the projections 258 to fracture the frangible container 220. Fracturing of the frangible container 220 can change the frangible container 220 from its closed state to release liquid 222 in reservoir 203, and in fluid communication with spore reservoir 236 and spores 215. Liquid 222 may include a nutrient medium (for example, a germination medium) for the spores, or liquid 222 may come in contact with the nutrient medium in a dry form (for example, in a powdered or tablet form) to form the nutrient medium, so that the mixture includes the sterile spores and the nutrient medium is formed. The mixture can then be incubated before or during the testing process, and the biological sterilization indicator 200 can be interrogated for signs of spore growth.
[0149] Figures 8 to 9 illustrate biological sterilization indicator 300 according to another embodiment of the present description. The biological sterilization indicator 300 includes many of these elements and characteristics described above with reference to the biological sterilization indicators 100 and 200 of figures 1 to 5 and 6 to 7, respectively. Consequently, the elements and characteristics that correspond to the elements and characteristics in the illustrated embodiment of figures 1 to 7 are provided with the same reference numbers in the 300 series. Reference is made to the description above from figures 1 to 7 in the appendix for a more complete description. of the characteristics and elements (and alternatives for these characteristics and elements) of the modality illustrated in figures 8 and 9.
[0150] The biological sterilization indicator 300 may include a compartment 302, which may include a first portion 304 and a second portion 306 (e.g., a lid) adapted to be coupled together to provide a one-piece biological sterilization indicator. The first portion 304 can include a lower portion 314 and the upper portion 316 separated by a wall 318, in which an opening system 317 can be formed which provides fluid communication between the lower portion 314 and the upper portion 316. Housing 302 may include a reservoir 303 that can be defined by one or both of the first portion 304 and the second portion 306 of compartment 302. The biological sterilization indicator 300 may further include spores 315 or a spore location positioned in fluid communication with the reservoir 303 (for example, in a 336 spore reservoir). The compartment 302 can be defined by at least one liquid impermeable wall, such as the wall 308 of the first portion 304 and / or wall 310 of the second portion 306.
[0151] As mentioned above, the biological sterilization indicator 300 may also include frangible container 320 that contains liquid 322. In some embodiments, only a portion of container 320 is frangible, for example, container 320 may include a frangible overcap (for example, a frangible barrier, film, membrane, or the like). Figure 9 shows an upper cross-sectional view of the biological sterilization indicator, with a frangible container 320 removed for clarity.
[0152] As shown in figures 8 and 9, the biological sterilization indicator 300 may also include an insertion element 330. As an example only, the insertion element 330 includes a first portion 331, a second portion 339, and a third portion 333. However, it should be understood that two or more of the first, second and third portions 331, 339 and 333 of the insert 330 can instead be integrally formed and supplied as an insert unit 330. Alternatively, the insert 330 may include identical structures and perform the same functions, as described below, but broken into separate portions differently. In some embodiments, at least some of the features of the insert 330 can be provided by the housing 302 itself.
[0153] As shown in figure 8, during sterilization and before activation, the second portion 306 can be in a first position 348 in relation to the first position 304. In the first position 348, the container 320 can be kept intact in one position separated from the lower portion 314 or the spore reservoir 336, and the liquid 322 can be contained within the container 320.
[0154] After sterilization, the biological sterilization indicator 300 can be activated to release liquid 322 from container 320 to move liquid 322 to spores 315. That is, the second portion 306 of compartment 302 can be moved to a second position (for example, see position 150 shown in figure 3 and described above) with respect to first portion 304.
[0155] The first portion 331 of the insert 330 can be adapted to hold or transport the container 320, so that the container 320 is kept intact in a location separate from the spores 315 during sterilization. That is, in some embodiments, the first portion 331 of the insert 330 can include (or function as) a support 332, for the container 320, particularly, before the container 320 is broken during the activation step (i.e., the step in which the liquid 322 is released from the container 320 and introduced into the spores 315, which typically occurs after a sterilization process).
[0156] Furthermore, the insert 330, can be adapted to keep the container 320 intact in a position in the compartment 302 that maintains at least a minimum spacing (for example, a minimum cross-sectional area) between the container 320 and compartment 302 and / or container 320 and any other components or structures in compartment 302 (for example, at least a portion of the insert 330, such as support 332, etc.), for example, to maintain a sterilizing path substantially constant 364 on the biological sterilization indicator 300. In some embodiments, the insert 330 can be adapted to hold the container 320 in a substantially consistent position in the compartment 302.
[0157] In some embodiments, at least a portion of the insert 330 can be adapted to allow the container 320 to move in compartment 302, for example, longitudinally in relation to compartment 302. In some embodiments, as shown in figure 8 , this movement can also be provided by the first portion 331 of the insert 330. Only by way of example, the first portion 331 may include one or more arms 342 (four arms 342 spaced around the inner side of the wall 308 of compartment 302 are shown by way of example only) adapted to hold and support the container 320 prior to activation and to allow the container 320 to move in compartment 302 during activation, for example, when the second portion 306 is moved relative to the first portion 304 of compartment 302. Only as an example, the arms 342 are shown in figures 8 and 9 as attached to a support 341 adapted to be attached to one end upper part of the third portion 333 of the insert 330. For example, the support 341 can be sized to be received in the reservoir 103 and sized to rest upon, or otherwise cooperate with or be coupled to, the third portion 333 of the insertion element 330. In some embodiments, however, the biological sterilization indicator 300 does not include support 341, and arms 342 can be coupled to or form a portion of the third portion 333 of insertion element 330 (and, in those embodiments, the insert 330 may not include a first separate portion 331), or the arms 342 may be provided by the compartment 302.
[0158] The 342 arms can be formed from a variety of materials and formatted and configured in a variety of ways. In some embodiments, the arms 342 can be formed of a flexible material that can support the weight of the container 320 before activation and that can be deformed, distorted or otherwise flexed in response to the movement of the second portion 306 of the compartment 302. In some embodiments, as shown in figures 8 and 9, the arms 342 can be integrally formed with, or coupled to, the support 341 at least partially by a flexible connector 334 (which can form at least a portion of the respective arm 342 or be coupled to to arm 342). Each flexible connector 334 can include one or more hinges or folds 335 (for example, a living joint) that allows arm 342 to move in relation to support 341, the third portion 333 of insert 330 and / or housing 302 to allow the container 320 to move in the compartment 302. Other possible structures and / or materials can be employed in the arms 342 to allow the container 320 to move in the compartment 302 without deviating from the character and scope of the present description.
[0159] In some embodiments, support 332 does not need to include arms 342, but can instead include a "trapdoor", or other barrier, film, movable or deformable / frangible door that supports container 320 while also allowing the sterilizer reach spores 315 during sterilization. As shown in figures 8 and 9, however, arms 342 provide support for container 320 prior to activation while also providing adequate space around container 320 for a sterilizer to move beyond container 320 and spores 315. One potential advantage that support 332 can have over barrier or trapdoor-type modalities is that the arms 342 of support 332 can provide additional space around container 320 for the sterilizer to move towards spores 315 during sterilization. In addition, a potential advantage that the support 332 can provide over the barrier type modalities or possibly over other supports 132 and 232 described above and illustrated in figures 1 to 5 and 6 to 7, respectively, is the fact that with the support 332, the bottom of the container 320 can be unrestricted when the container 320 is fractured, so that the liquid 322 can be released from the container 320 and moved towards the spores 315 with relative ease and reliability.
[0160] In addition, in the embodiment illustrated in figures 8 and 9, the first portion 331 of the insert 330 includes four arms 342 that are circumferentially spaced around the container 320. However, this need not be the case. In some embodiments, an arm 342 or a base (e.g., door, flap, film, barrier, etc.) alone is sufficient to hold the container 320 before activation. As shown in figures 8 and 9, if support 332 includes arms 342, support 332 can be configured to keep container 320 in compartment 302 separate from spores 315.
[0161] In some embodiments, at least a portion of the insert 330 can be adapted to fracture the container 320, for example, as the container 320 is moved in compartment 302, for example, longitudinally in relation to compartment 302. As shown in figures 8 and 9, the arms 342 do not include any projections positioned to fracture the container 320; however, this modality can be used without deviating from the character and scope of the present description. Instead, in the embodiment illustrated in figures 8 and 9, this fracture can be provided by the third portion 333 of the insert 330. As shown in figures 8 and 9, in some embodiments, the third portion 333 of the insert 330 can be positioned within compartment 302. In some embodiments, the third portion 333 may be integrally formed with compartment 302 (for example, provided by compartment 302).
[0162] As shown in figures 8 and 9, the third position 333 can include a base 327, at least one side wall 329 which can be adapted to fit within (e.g., adjacent) to the wall 308 of compartment 302, and one or more projections 358 extending inwardly from the side wall 329. The base 327 of the third portion 333 of the insert 330 can be adapted to be in a boundary position with the separation wall 318 to provide the necessary strength and strength to break container 320.
[0163] The projections 358 can be positioned to fracture the container 320 as the container 320 is moved in relation to the compartment 302 (for example, along a longitudinal direction D3 of the compartment 302). This movement of the container 320, for example, can occur in response to the second portion 306 of the compartment 302 being moved relative to the first portion 304 of the compartment 302 (for example, from the first position 348 to a second position).
[0164] In some embodiments, the 358 projections may include one or more edges (for example, tapered edges) or points or otherwise be configured to concentrate the crushing force to increase the pressure in the container 320 in the regions adjacent to the 358 projections , and to facilitate the fracture of the container 320 more easily in one or more desired regions. In some embodiments, the projections 358 (for example, an upper end 359 of the projections 358) may work at least partially to hold a portion of the container 320, and the projections 358 can reduce the total effort or force required to move the second portion 306 with respect to the first portion 304 and to fracture the container 320 (or a portion thereof). As shown in figure 8, in some embodiments, projections 358 can be positioned to fracture container 320 at its radiated end, for example, when an oblong or capsule-shaped container 320 is employed.
[0165] As shown in figures 8 to 9, the projections 358 are integrally formed with the side wall 329 of the third portion 333 of the insert 330; however, it should be understood that the projections 358 can instead be formed integrally with the wall 308 of the compartment 302 (for example, similar to the projections 258 illustrated in figures 6 and 7 and described above). In addition, projections 358 can be formed separately from compartment 302 and / or insertion element 330 and coupled to compartment 302 and / or insertion element 330, or projections 358 can also be provided by an additional insertion element. In these embodiments, the projections 358 can each be a separate insertion element, or multiple projections 358 can be provided by one or more insertion elements. In addition, these inserts can be configured to be in a border position 318 to inhibit movement of that insertion element in the vicinity of spores 315 (for example, the bottom portion 314 of compartment 302).
[0166] Furthermore, as shown in figure 8, the projections 358 can extend a certain distance along the longitudinal direction D3, and the length and / or thickness (for example, which can vary along the length) of the projections 358 can be adjusted to control fracture of container 320 in a desired position in compartment 302 and in a desired manner. The configuration of projections 358 is shown in figures 8 and 9 only as an example.
[0167] Furthermore, the biological sterilization indicator 300 is shown in figures 8 and 9 as including three projections 358 for example only, but it should be understood that one projection 358 or as many as are structurally possible can be employed. In addition, projections 358 can be shaped and sized as desired, depending on the shape and dimensions of housing 302, the shape and dimensions of insertion element 330 or the third portion 333 of insertion element 330, and the desired shape and position for break container 320.
[0168] In some embodiments, as shown in figure 8, at least a portion of compartment 302 may include a tapered portion 346 in which compartment 302 (for example, wall 308, or an internal surface thereof) is generally tapered. in the longitudinal direction D3 of the compartment 302. As a result, the cross-sectional area in the compartment 302 can generally decrease along the longitudinal direction D3. In some embodiments, the projections 358 may vary in thickness (that is, towards the container 320, for example, in a radial direction) along the longitudinal direction D3, so that the area in cross section available for the container 320 in general it decreases as the container 320 is moved in the compartment 302 during activation, even though the external dimension of the compartment 302 may not change.
[0169] In some embodiments, as shown in figure 8, the insert 330 (for example, the first portion 331 of the insert 330) can be sized and shaped to allow the container 320 to be held above the projections 358 and outside the tapered portion 346 of compartment 302 during sterilization and prior to activation to inhibit accidental or premature activation of the biological sterilization indicator 300. This configuration can also inhibit inadvertent rupture due to shock or material expansion (for example, due to exposure to heat during a sterilization process).
[0170] As shown in figure 8, support 332 is configured to hold a bottom portion of container 320, and projections 358 are positioned to fracture container 320 at a location close to the bottom of container 320 as it is positioned in compartment 302. This configuration can allow container 320 to be ruptured close to its bottom and can facilitate the removal of liquid 322 from container 320, which can improve the availability of liquid 322 to spores 315, and can improve the reliability of release of liquid 322 in fluid communication with spores 315 (for example, with spore reservoir 336). This configuration is shown by way of example only, however, it should be understood that the projections 358 can be configured and positioned to fracture the container 320 in any desired way.
[0171] The third portion 333 of the insert 330 can further be adapted to facilitate or allow fluid movement (e.g., movement of liquid 322) in the lower portion 314 of compartment 302; minimizing the movement of fractions or portions (e.g., solids) of the fractured container 320 in the lower portion 314 of compartment 302, i.e., collecting and / or retaining portions of the fractured container 320; and / or minimize the spread of spores 315 and / or signals through the lower portion 314 of compartment 302. For example, in some embodiments, as shown in figures 8 and 9, the third portion 333 of the insert 330 can be shaped and sized to be in a boundary position or to be attached to the wall or partition 318. That is, in some embodiments, the base 327 can be dimensioned to fit within the upper portion 314 of compartment 302 and be in a boundary position with the wall 318. In addition In addition, the base 327 may include one or more openings 377 which can act as a grid to allow liquid 322 to move in the lower portion 314 of compartment 302 when liquid 322 is released from container 320, while inhibiting movement of portions of the fractured container 320 for the proximity of spores 315, where these portions can affect the detection (e.g., optical detection) of spore growth. In addition, the base 327 and / or one or more openings 377 can be configured to prevent fluid from moving upwards in the compartment 302, that is, from the lower portion 314 to the upper portion 316 of the compartment 302.
[0172] As an example only, the base 327 illustrated in figures 8 and 9 includes three rectilinear openings 377; however, it should be understood that few or more openings 377 can be employed, and the openings and base 327 can include a variety of shapes and configurations to facilitate fluid movement in the lower portion 314, while collecting and / or retaining the container portions fractured 320, and while potentially inhibiting fluid movement through the lower portion 314 (for example, openings 377 may taper towards spores 315, so that openings 377 are smaller on the spore side of base 327).
[0173] In some embodiments, as shown in figure 8, the insertion element 330 can be additionally adapted to accommodate the spores 315. For example, in the embodiment illustrated in figures 8 and 9, the second portion 339 of the insertion element 330 can include the spore reservoir 336, in which the spores 315 can be positioned, either directly or on a substrate. In some embodiments, the biological sterilization indicator 300 does not include a spore reservoir 336 (or a second portion 339 of the insert 330) and the spores 315 can be positioned in the lower portion 314 of compartment 302 directly or on a substrate. The spore reservoir 336 is shown by way of example only as substantially similar to that of the biological sterilization indicators 100 and 200 illustrated in figures 1 to 5 and 6 and 7, respectively. However, it should be understood that a variety of different structures can be used to provide a spore reservoir 336.
[0174] Just as an example, the insert 330 illustrated in figures 8 and 9 is shown as formed by three separate portions 331, 333 and 339. Together, the three portions 331, 333 and 339 of the insert 330 include at least the following: means for maintaining the container 320 before activation; to allow movement of the container 320 in the compartment 302; to provide a path of sterilizer 364; to provide a spore reservoir 336; to collect and / or retain the fractured container 320 after activation (or at least partially inhibit movement of portions of the fractured container 320 in the lower portion 314 of compartment 302); and / or to minimize diffusion of spores 315 and / or signals from the lower portion 314 to the upper portion 316 of compartment 302 after activation. However, it should be understood that the insert 330 can be divided into portions differently or it can be formed by a simple unitary device, or that portions can be provided by the compartment 302 itself.
[0175] In use, the biological sterilization indicator 300 can be placed together with a lot of sterilizer during a sterilization process. During sterilization, the sterilizing path 364 is in fluid communication with reservoir 303, with spore reservoir 336, and with spores 315, so that the sterilizer can reach the spores to produce sterile spores. In addition, during sterilization, the frangible container 320 is in a closed state in which liquid 322 is protected from the sterilizer and is not in fluid communication with reservoir 303, with spore reservoir 336, with spores 315, or with the trajectory of sterilizer 364.
[0176] After sterilization, the effectiveness of the sterilization process can be determined using the biological sterilization indicator 300. The second portion 306 of compartment 302 can be unlocked, if previously locked in the first position 348, and moved from the first position 348 for a second position. This movement of the second portion 306 can cause one or more arms 342 to move away from the container 320 (for example, causing the connectors 334 of the first portion 331 of the insert 330 to flex the respective joints 335), which can allow the frangible container 320 to move in the compartment 302, for example, along the longitudinal direction D3 of the compartment 302. The frangible container 320 can then be forced to come into contact with the projections 358 provided by the third portion 333 of the insert 330 to fracture the frangible container 320. Fracturing of the frangible container 320 can change the frangible container 320 from its closed state to release liquid 322 in reservoir 303, and in fluid communication with the spore reservoir 336 and spores 315 The fractured portions of the container 320 can be collected, or at least prevented from moving in the vicinity of the spores 315, for example, by the third portion 333 insertion element 330. Liquid 322 may include the nutrient medium (for example, germination medium) for the spores, or liquid 322 may come in contact with the nutrient medium in a dry form (for example, in a powdered or tablet form) to form the nutrient medium, so that the mixture including the sterile spores and the nutrient medium is formed. The mixture can then be incubated before, or during, a testing process, and the biological sterilization indicator 300 can be interrogated for signs of spore growth.
[0177] Figures 10 to 13 illustrate a biological indicator of sterilization 400 according to another embodiment of the present description. The biological sterilization indicator 400 includes many of the elements and characteristics described above with reference to the biological sterilization indicators 100, 200 and 300 of figures 1 to 5, 6 to 7 and 8 to 9, respectively. Consequently, the elements and characteristics that correspond to the elements and characteristics in the illustrated embodiment of figures 1 to 9 are provided with the same reference numbers in the 400 series. Reference is made to the description above from figures 1 to 9 in the appendix for a more complete description. of the characteristics and elements (and alternatives for these characteristics and elements) of the modality illustrated in figures 10 to 13.
[0178] The biological sterilization indicator 400 may include a compartment 402, which may include a first portion 404 and a second portion 406 (e.g., a lid) adapted to be coupled together to provide a one-piece biological sterilization indicator. The first portion 404 may include a lower portion 414 and an upper portion 416 separated by a wall 418, in which an opening system 417 can be formed which provides fluid communication between the lower portion 414 and the upper portion 416. Housing 402 may include a reservoir 403 which can be defined by one or both of the first portion 404 and the second portion 406 of compartment 402. The biological sterilization indicator 400 may further include spores 415 or a spore location positioned in fluid communication with the reservoir 403 (for example, in a 436 spore reservoir).
[0179] The compartment 402 can be defined by at least one liquid impermeable wall, such as a wall 408 of the first portion 404 and / or a wall 410 of the second portion 406. As shown in figure 10, the second portion 406 of the compartment 402 it may include one or more openings 407 to provide fluid communication between the interior of compartment 402 (e.g., reservoir 403) and the ambience. For example, one or more openings 407 can provide fluid communication between spores 415 and the environment during a sterilization process, and can serve as an input to the biological sterilization indicator 400 and as an input to a sterilizing path 464.
[0180] As mentioned above, the biological sterilization indicator 400 may further include the frangible container 420 which contains a liquid 422. In some embodiments, only a portion of the container 420 is frangible, for example, the container 420 may include a frangible overcap (for example, a frangible barrier, film, membrane, or the like). Figure 13 shows an upper cross-sectional view of the biological sterilization indicator 400 obtained at a location close to the bottom of the container 420.
[0181] As shown in figures 10 to 13, the biological sterilization indicator 400 may further include an insertion element 430. Just as an example, insertion element 430 includes a first portion 431 and a second portion 439. However, it should be understood that the first and second portions 431 and 439 of insertion element 430 can instead be integrally formed and supplied as a unitary insertion element 430. Alternatively, insertion element 430 can include the same structures and perform the same functions as described below, but broken into separate portions in a different way. In some embodiments, at least some of the features of the insertion element 430 can be provided by the housing 402 itself.
[0182] As shown in figures 11 and 12, the second portion 406 of compartment 402 can be adapted to be coupled to the first portion 404. For example, as shown in figures 10 to 12, the second portion 406 can be adapted to be coupled to the upper portion 416 of the first portion 404 of compartment 402. In some embodiments, as shown in figures 10 to 12, the second portion 406 may be in the form of a lid that can be sized to receive at least a portion of the first portion 404 of compartment 402.
[0183] As shown in figure 11, during sterilization and before activation, the second portion 406 can be in a first position 448 in relation to the first portion 404. In the first position 448, the container 420 can be kept intact in one position separated from the lower portion 414 or the spore reservoir 436, and the liquid 422 can be contained within the container 420.
[0184] As shown in figure 12, after sterilization, the biological sterilization indicator 400 can be activated to release liquid 422 from container 420 to move liquid 422 to spores 415. That is, the second portion 406 of compartment 402 it can be moved to a second position 450 with respect to the first portion 404. Similar to the embodiment illustrated in figures 1 to 4 and described above, the first portion 404 of compartment 402 may include a step or projection 452 on its outer surface, and the second portion 406 may include a lip or protuberance 454 that can be adapted to engage with step 452 in the first portion 404 when the second portion 406 is moved from the first position 448 to the second position 450. In these embodiments, the second portion 406 may reversibly engage the first portion 404 with the second portion 450, and in some embodiments, the second portion 406 may irreversibly engage with the first portion 404. However, d it should be understood that the coupling structures and means for the first portion 104 and the second portion 106 are shown in figures 10 to 13 by way of example only, and any of the coupling means described above may, instead, be employed between the first portion 404 and the second portion 406 of compartment 402.
[0185] The first portion 431 of the insert 430 can be adapted to hold or transport the container 420, so that the container 420 is kept intact in a location separate from the spores 415 during sterilization. That is, in some embodiments, the first portion 431 of the insert element 430 may include (or function as) a support 432 for the container 420, particularly, before the container 420 is broken during the activation step (i.e., the step wherein liquid 422 is released from container 420 and introduced into spores 415, which typically occurs after the sterilization process).
[0186] In addition, the insert element 430 can be adapted to keep the container 420 intact in a position in the compartment 402 that maintains at least a minimum spacing (for example, a minimum cross-sectional area of space) between the container 420 and compartment 402 and / or between container 420 and any other components or structures in compartment 402 (for example, at least a portion of the insert element 430, such as support 432, etc.), for example, to maintain a path of substantially constant sterilizer 464 on biological sterilization indicator 400. In some embodiments, the insert element 430 can be adapted to hold the container 420 in a substantially consistent location in compartment 402.
[0187] In some embodiments, at least a portion of the insert element 430 can be adapted to allow the container 420 to move in compartment 402, for example, longitudinally in relation to compartment 402. In some embodiments, as shown in figures 10 to 12, this movement can be provided by the first portion 431 of the insert element 430. Just as an example, the first portion 431 can include one or more projections 458 (three projections 458 spaced around the container 420 are shown only by way of example) adapted to hold and hold container 420 prior to activation and allow container 420 to move in compartment 402 during activation, for example, when the second portion 406 is moved relative to the first portion 404 of compartment 402. Only as an example, the projections 458 are shown in figures 10 to 13 as attached to a base or support 427 adapted to be in a borderline position with the wall of separation 418. For example, base 427 can be dimensioned to be received in reservoir 403 and dimensioned to rest on top, or be in a borderline position, or otherwise cooperate with, or be coupled to, a separation wall 418. In in some embodiments, however, insertion element 430 does not include base 427, and projections 458 may be coupled to or form a portion of compartment 402. In some embodiments, insertion element 430 is integrally formed with or provided by compartment 402 .
[0188] Just as an example, the 458 projections are illustrated as relatively rigid and stationary. That is, unlike arms 142, 242 and 342 of the modalities described above and shown in figures 1 to 5, 6 to 7 and 8 to 9, respectively, the projections 458 may not be adapted to flex, twist, deform or otherwise follow the orientation of the container 420 as it is moved in the compartment 402. Instead, the projections 458 can each be configured to have an upper end 459 above which the container 420 can be positioned and kept intact before activation. As shown in figure 11, in some embodiments, the projections 458 can be positioned to fracture the container 420 at its radiated end, for example, when an oblong or capsule-shaped container 420 is employed.
[0189] A potential advantage of having the projections 458 forming at least a portion of the support 432 is that the bottom of the container 420 can be unrestricted when the container 420 is fractured, so that the liquid 422 can be released from the container 420 and moved towards spores 415 with relative ease and reliability.
[0190] Although the projections 458 are illustrated as relatively rigid and stationary in the mode shown in figures 10 to 13, in some embodiments, the insertion element 430 can be adapted to be mobile in relation to the compartment of a biological sterilization indicator, for example example, because of a connector (like connector 134 shown in figures 1 to 5 and its equivalents). In these embodiments, a connector can couple the first portion 431 of the insertion element 430 to the second portion 439 of the insertion element 430, or the other portion of the insertion element 430.
[0191] In addition, in some embodiments, the projections 458 can be movable (for example, they can flex) towards and away from container 420 (for example, radially inward and radially outward in relation to container 420), similarly to the movement of the arms 142 shown in figures 1 to 5 and described above. In other embodiments, another structure or compartment 402 may cause projections 458 to move in and out. For example, in some embodiments, the projections 458 may flex inward or outward in response to the projections 458 (or the first portion 431 of the insert element 430) being moved in compartment 402. In these embodiments, the projections 458 may include additional projections (for example, similar to projections 158 illustrated in figures 1 to 5 and described above) that extend towards container 420. In these embodiments, insertion element 430 can be used to fracture container 420 in a direction which is substantially perpendicular to a flat side of the container 420, for example, when an oblong or capsule-shaped container 420 is employed. In these embodiments, the fracture of the container 420 along its side can be achieved, along with the maintenance of some open spaces around the lower end of the container 420 to facilitate the movement of the liquid 422 of the container 420 to the proximity of the spores 415 when container 420 is fractured.
[0192] In the embodiment illustrated in figures 1 to 5, the components of the support are called "arms" 142, while the rupture components are called "projections" 158. In the embodiment illustrated in figures 10 to 13, the components of support and rupture are called "projections" 458. However, it should be understood that the terms "arms" and "projections" are used purely for descriptive and clarity purposes, but that, in some modalities, these terms can be used in interchangeably, and arms 142 may instead be called "projections" 142, and projections 158 may be called "protrusions" or extensions of projections 142, etc.
[0193] In some embodiments, at least a portion of the insert element 430 can be adapted to the fracture of the container 420, for example, as the container 420 is moved in compartment 402, for example, longitudinally in relation to compartment 402. As shown in figures 10 to 13, the fracture of the container 420 can also be provided by the first portion 431 of the insertion element 430, and particularly, by the projections 458. As shown in figures 10 to 12, the base 427 of the first portion 431 of the insertion member 430 can be adapted to be in a boundary position with the separation wall 418 to provide the strength and strength necessary to fracture container 420 as container 420 is moved in compartment 402.
[0194] The projections 458 can be positioned to fracture container 420 as container 420 is moved relative to compartment 402 (for example, along the longitudinal direction D4 of compartment 402), for example, in response to the second portion 406 of compartment 402 being moved relative to the first portion 404 of compartment 402 (for example, from the first position 448 to the second position 450).
[0195] In some embodiments, the 458 projections may include one or more edges (for example, tapered edges) or points or otherwise be configured to concentrate the crushing force to increase the pressure on the container 420 in the regions adjacent to the projections 458, and to facilitate fracture of container 420 more easily and in one or more desired regions. In some embodiments, this concentration of force may reduce the effort or total force required to move the second portion 406 with respect to the first portion 404 and to fracture the container 420 (or a portion thereof).
[0196] As shown in figures 10 to 13, the projections 458 are integrally formed with the base 427 of the first portion 431 of the insert 430; however, it should be understood that the projections 458 can instead be formed integrally with the wall 408 of compartment 402 (for example, similar to the projections 258 illustrated in figures 6 to 7 and described above). In some embodiments, the projections 458 can be coupled to compartment 402 and / or the second portion 439 of insertion element 430, or projections 458 and base 427 can be provided by separate inserts 430. In these embodiments, projections 458 each can be a separate insertion element, or multiple projections 458 can be provided by one or more insertion elements. In addition, the first portion 431 of the insertion element 430 can be configured to be in a position bordering the wall 418 to inhibit movement of the first portion 431 of the insertion element 430 in the vicinity of the spores 415 (for example, the lower portion 414 402).
[0197] In addition, in some embodiments, as shown in figures 10 to 12, the projections 458 may extend a certain distance along the longitudinal direction D4, and the length and / or thickness (for example, which may vary along the length) of the projections 458 can be adjusted to control the fracture of the container 420 at a desired position in compartment 402 and in the desired manner. The configuration of the 458 projections is shown in figures 8 to 9 only as an example.
[0198] In general, each of the 458 projections is shown by way of example only as responsible for the increase in thickness (for example, inwards towards container 420 or center of compartment 402) along the longitudinal direction D4 towards spores 415. This configuration can decrease the cross-sectional area that is available for container 420, as container 420 is moved towards spores 415, for example, in response to the second portion 406 being moved to the second position 450.
[0199] In addition, the biological sterilization indicator 400 is shown in figures 10 to 13 as including three projections 458 for example only, but it should be understood that one projection 458 or as many as are structurally possible can be employed. In addition, projections 458 can be shaped and sized as desired, depending on the shape and dimensions of compartment 402, the shape and dimensions of compartment 430 or the first portion 431 of insertion element 430, and / or the desired shape and position for fracture container 420.
[0200] In some embodiments, as shown in figures 10 to 12, at least a portion of compartment 402 may include a tapered portion 446 in which compartment 402 (for example, wall 408, or an internal surface thereof) in general tapers in the longitudinal direction D4 of compartment 402. As a result, the cross-sectional area in compartment 402 can, in general, decrease along the longitudinal direction D4. In some embodiments, the one or more projections 458 alone may vary in thickness (that is, towards the container 420, for example, in a radial direction) along the longitudinal direction D4, so that the area in cross section available for container 420 generally decreases as container 420 is moved in compartment 402 during activation, even if the dimensions of compartment 402 do not change (for example, even if compartment 402 does not include any tapered portion 446, internally or externally ).
[0201] As shown in figures 10 to 13, the upper end 459 of each of the projections 458 includes a rounded, curved or arched surface, which can facilitate the movement of the container 420 from the first position 448 on which the container 420 rests at least partially above the upper end 459 of the projection 458 to a position where the container 420 is forced into a region of area in smaller cross section between the projections 458 (or between the wall 408 of the compartment 402 and one or more projections 458). In addition, the rounded upper end 459 can inhibit premature rupture of container 420, which can inhibit premature activation of the biological sterilization indicator 400 (i.e., premature release of liquid 422).
[0202] In some embodiments, as shown in figure 11, the insert element 430 (for example, the first portion 431 of the insert element 430) can be sized and shaped to allow the container 420 to be kept above projections 458 and outside the adjacent region of any portion of a surface facing into one or more of the 458 projections to inhibit accidental or premature activation of the biological sterilization indicator 400. This configuration can also inhibit inadvertent rupture due to material shock or expansion ( for example, due to exposure to heat during a sterilization process).
[0203] As shown in figures 10 to 12, the support 432, which can be formed at least partially by the upper ends 459 of the projections 458, can be configured to hold the lower portion of the container 420, and the projections 458 can be positioned to fracture container 420 at a location near the bottom of container 420 as it is positioned in compartment 402. This configuration can allow container 420 to be broken close to its bottom and can facilitate the removal of liquid 422 from container 420, the which can increase the availability of liquid 422 to spores 415, and can increase the reliability of release of liquid 422 in fluid communication with spores 415 (for example, with spore reservoir 436). This configuration is shown only as an example, however, it must be understood that the projections 458 can be configured and positioned to fracture the container 420 in any desired way.
[0204] In some embodiments, the first portion 431 of the insert element 430 (for example, the base 427) can be adapted for one or more actions to facilitate or allow fluid movement (for example, the movement of liquid 422) in lower portion 414 of compartment 402; minimizing the movement of fractions or portions (e.g., solids) of the fractured container 420 in the lower portion 414 of compartment 402, i.e., collecting and / or retaining portions of the fractured container 420; and / or minimize the diffusion of spores 415 and / or signals out of the lower portion 414 of compartment 402. For example, in some embodiments, base 427 can be configured to function as a grid, similar to base 327 described above in relation to figures 8 and 9.
[0205] In the embodiment illustrated in figures 10 to 13, the base 427 of the first portion 431 of the insert element 430 is generally U-shaped or horseshoe-shaped and includes a central opening 477 (see figure 10) that facilitates movement of the sterilizer towards the spores 415 during sterilization and the movement of the liquid 422 towards the spores 415 during activation. The horseshoe shape of the base 427 can increase the opening system between the upper portion 416 and the lower portion 414 of compartment 402; however, this format is shown as an example only, and other formats can be used.
[0206] In the embodiment illustrated in figures 10 to 13, the first portion 431 of the insert element 430 is illustrated including three projections 458 which are approximately equally spaced around the container 420 and / or around the inner surface of the wall 408 of the compartment 402. However, in some embodiments, first portion 431 may include a solid (for example, substantially annular) projection 458 extending upwardly from base 427 along wall 408. However, the use of one or more narrower projections 458, such as those shown in figures 10 to 13, can provide a substantially constant or substantially unobstructed path of sterilizer 464 around container 420.
[0207] In some embodiments, as shown in figures 10 to 13, the insertion element 430 can be further adapted to accommodate the spores 415. For example, in the embodiments illustrated in figures 10 to 13, the second portion 439 of the insertion element 430 may include a spore reservoir 436, in which the spores 415 can be positioned, either directly or on a substrate. In some embodiments, the biological sterilization indicator 400 does not include a spore reservoir 436 (or a second portion 439 of the insert element 430), and the spores 415 can be positioned in the lower portion 414 of compartment 402 directly or on a substrate. The spore reservoir 436 is shown by way of example only as substantially similar to that of the biological sterilization indicators 100, 200 and 300 illustrated in figures 1 to 5, 6 to 7 and 8 and 9, respectively. However, it should be understood that a variety of different structures can be used to provide a spore reservoir 436.
[0208] By way of example only, the insertion element 430 illustrated in figures 10 to 13 is shown as formed by two separate portions 431 and 439. Together, the two portions 431 and 439 of insertion element 430 include at least the following : means for securing container 420 before activation, to allow movement of container 420 in compartment 402, to fracture container 420, to facilitate the movement of liquid 422 in the lower portion 414 of compartment 402, and / or to provide a path of sterilizer 464. However, it should be understood that the insertion element 430 can be divided into different portions or can be formed by a simple unitary device, or that portions can be provided by compartment 402.
[0209] In use, the biological sterilization indicator 400 can be placed together with a lot of sterilizer during a sterilization process. During sterilization, the sterilizing path 464 is in fluid communication with the reservoir 403, with the spore reservoir 436, and with the spores 415, so that the sterilizer can reach the spores to produce sterile spores. In addition, during sterilization, the frangible container 420 is in a closed state in which liquid 422 is protected from the sterilizer and is not in fluid communication with reservoir 403, with spore reservoir 436, with spores 415, or with the trajectory of sterilizer 464.
[0210] After sterilization, the effectiveness of the sterilization process can be determined using the biological sterilization indicator 400. The second portion 406 of compartment 402 can be unlocked, if previously locked in the first position 448, and moved from first position 448 (see figure 11) to second position 450 (see figure 12). This movement of the second portion 406 may cause the container 420 to move in the compartment 402 (for example, along the longitudinal direction D4) from a position above the upper ends 459 of the projections 458 to a position within the interior of the projections 458, which can lead to fracture of the frangible container 420. Fracture of the frangible container 420 can change the frangible container 420 from its closed state to release liquid 422 in reservoir 403, and in fluid communication with the spore reservoir 436 and with spores 415. Liquid 422 may include a nutrient medium (for example, germination medium) for the spores, or liquid 422 may come in contact with the nutrient medium in a dry form (for example, in a powdered or tablet form) to form the nutrient medium, so that the mixture including the sterile spores and the nutrient medium is formed. The mixture can then be incubated before or during a testing process, and the biological sterilization indicator 400 can be interrogated for signs of spore growth.
[0211] Figures 14 to 17 illustrate the insertion elements 530, 630, 730 and 830 according to other modalities of the present description. Insertion elements 530, 630, 730 and 830 include many of the same elements and characteristics described above with reference to insertion elements 130, 230, 330 and 430 of figures 1 to 5, 6 to 7, 8 to 9 and 10 to 13 , respectively. Consequently, the elements and characteristics corresponding to the elements and characteristics illustrated in the form of figures 1 to 13 are provided with equal reference numbers in the 500, 600, 700 or 800 series. Reference is made to the description above in figures 1 to 13 in annex for a more complete description of the features and elements (and alternatives to these features and elements) of the modality illustrated in figures 14 to 17. In addition, any of the additional descriptions or alternative modalities mentioned below with reference to the insert elements 530, 630 , 730 and 830 can also be applied to any biological sterilization indicators 100, 200, 300 and 400 described above and illustrated in figures 1 to 13.
[0212] Each of the insertion elements 530, 630, 730 and 830 share some similarities with the third portion 333 of the insertion element 330 of figures 8 and 9 and with the first portion 431 of the insertion element 430 of figures 10 to 13 As a result, any of the inserts 530, 630, 730 and 830 can be used as the third portion 333 of the insertion element 330 of figures 8 and 9 and / or of the first portion 431 of the insertion element 430 of figures 10 to 13. However, it should be understood that any of the insertion elements 530, 630, 730 and 830 can be used in any of the biological sterilization indicators 100, 200, 300 or 400 described above and illustrated in figures 1 to 13 , instead of or in addition to the structures shown in figures 1 to 13 and described above.
[0213] Each of the insertion elements 530, 630, 730 and 830 is adapted to secure and support a frangible container before activating a biological sterilization indicator, to allow the container to move in the compartment (for example, during activation of the biological sterilization indicator), as well as fracturing the container during activation, for example, as a second portion of a compartment is moved relative to a first portion of the compartment.
[0214] As shown in figure 14, in some embodiments, the insert element 530 may include one or more projections 558 adapted to hold and support the frangible container before activation and allow the container to move in the biological sterilization indicator during activation. As an example only, the projections 558 are shown in figure 14 as attached to a base or support 527, which can be adapted to be in a borderline position with a separation wall in a biological sterilization indicator (for example, the wall 118 shown in figures 1 to 4). For example, base 527 is angled to cooperate with or be coupled to an angled separation wall. In addition, the base 527 (and the entire insert 530) can be sized to be received within a biological sterilization indicator.
[0215] For example only, projections 558 are illustrated as relatively rigid and stationary, and projections 558 can each be configured to have an upper end 559 above which a container can be positioned and kept intact before activation. That is, the upper ends 559 can function as a support 532. The insert element 530 and particularly the support 532 can be adapted to hold or support a container, so that the container is kept intact in a location separate from the spores during sterilization. In addition, the insert element 530 and particularly the support 532 can be adapted to keep the container intact in a position on a biological sterilization indicator that maintains at least minimum spacing (for example a minimum area in cross section of space) between the container and a compartment or wall of the sterilization biological indicator and / or between the container and any other components or structures in the compartment (for example, at least a portion of the insert element 530, such as support 532, etc.), for example example, to maintain a substantially constant sterilizing trajectory in the biological sterilization indicator. In some embodiments, the insert 530 can be adapted to hold the container in a substantially consistent location in the compartment.
[0216] For example only, the insert 530 includes two projections 558. A potential advantage of having the projections 558 kept in the container without requiring an additional support or base to hold the container, and having few (for example, two instead of three or more) projections 558 is that the container can be unrestricted when the container is fractured, so that any liquid contained within the container can be released from the container and moved towards the spores in a biological sterilization indicator with relative ease and reliability. In some embodiments, the projections 558 can be positioned to fracture the container at a radiated end, for example, when an oblong or capsule-shaped container is employed.
[0217] The base 527 of the insert element 530 can be adapted to be in a boundary position with an inner wall, partition or base of a biological sterilization indicator to provide the strength and resistance necessary to fracture the container as the container is moved in relation to the insertion element 530. In some embodiments, however, the insertion element 530 can be adapted to be movable in relation to a compartment of a biological sterilization indicator because of a connector (such as connector 134 shown in the figures 1 to 5 and their equivalents).
[0218] For example only, projections 558 can each include a surface facing inwards that is substantially flat. As a result, to restrict a frangible container and cause it to fracture as it is moved in relation to the insertion element 530, the projections 558 can vary in thickness or be angled in relation to a direction (for example, a longitudinal direction) ) of a biological sterilization indicator along which the container is moved during activation. This variable thickness or angulation can create a generally decreasing cross-sectional area that is available to the container as it is moved in the biological sterilization indicator during activation.
[0219] As shown in figure 14, projections 558 are formed integrally with base 527 and generally extend upwards in relation to base 527. In addition, as shown in figure 14, projections 558 can extend to a certain distance along a longitudinal direction of the biological sterilization indicator (for example, the direction along which a container will be moved during activation), and the length and / or thickness (for example, which can vary over time). length) of the projections 558 can be adjusted to control the fracture of the container 520 in the desired position in the compartment 502 and in a desired manner.
[0220] In some embodiments, the projections 558 can be adapted to fit adjacent to an internal surface of a compartment wall (for example, 108 of figures 1 to 4), so that even if the projections 558 flex or they sag in any way in response to a container being moved between the 558 projections, the integrity of the compartment wall will provide sufficient strength to provide the strength necessary to fracture the container as needed during activation.
[0221] In some embodiments, the projections 558 can be configured to sit far from the wall 508 of compartment 502 before activation. In some embodiments, the projections 558 can be positioned more directly below the container 520 to provide substantial support. Upon activation in these modalities, the container 520 can be forced down between the projections 558, which causes the projections 558 to flex outward until the projections 558 are in a borderline position with the wall 508 of the first portion 504 of the compartment 502. At that point, the projections 558 can fracture the container 520.
[0222] As shown in figure 14, and upper end 559 of each of the projections 558 includes a rounded, curved or arched surface, which can facilitate the movement of a container in relation to the 558 projections, and which can also inhibit premature rupture of the container and premature activation (ie premature release of a liquid contained in the container).
[0223] As additionally shown in figure 14, the base 527 of the insertion element 530 is generally U-shaped or horseshoe-shaped and includes a central opening 577 that facilitates the movement of the sterilizer towards the spores in a biological indicator of sterilization and also facilitates the movement of the liquid contained in the frangible container (that is, after the frangible container has been fractured) towards the spores during activation. The horseshoe shape of base 527 includes an open side, which can create an additional open space between a portion of a biological sterilization indicator and the other portion of a biological sterilization indicator, when compared to a base that did not include an open side . As a result, the lockable shape can increase fluid communication between portions of a biological sterilization indicator.
[0224] The insertion element 630 illustrated in figure 15 is substantially the same as, and functions substantially similar to, the insertion element 430 of figures 10 through 13. The insertion element 630 includes three projections 658 that extend upwards from the horseshoe-shaped base 627 which includes a central opening 677 and which can be angled (or can include an angled surface) to fit adjacent to an inner wall or partition of a sterilizing biological indicator. In addition, each of the projections 658 includes an at least partially rounded or arcuate upper end 659. The upper ends 659 can function as a support 632. The insert element 630 and particularly the support 632 can be adapted to hold or support a container , so that the container is kept in a separate place from the spores during sterilization. In addition, the insert element 630 and particularly the support 632 can be adapted to keep the container intact in a position on the biological sterilization indicator that maintains at least a minimum spacing (for example, a minimum cross-sectional area of space) between the container and a compartment or wall of the sterilization biological indicator and / or between the container and any other components or structures in the compartment (for example, at least a portion of the insert element 630, such as support 632, etc.), for example example, to maintain a substantially constant sterilizing trajectory in the biological sterilization indicator. In some embodiments, the insert element 630 can be adapted to hold the container in a substantially consistent location in the compartment.
[0225] A difference between the insertion element 630 of figure 15 and the insertion element 430 of figures 10 to 13 is that the insertion element 630 includes a side wall 629 extending upwards from the base 627 from from which the projections 658 extend. In other words, the base 627 may include a height greater (for example, in a longitudinal direction of a biological sterilization indicator) than the base 427 of the insert element 430 of figures 10 to 13 This side wall 629 can provide additional rigidity and structural integrity (for example, providing the necessary strength to fracture a container during activation of a biological sterilization indicator). However, the insert element 430 can, in general, have less mass and require less material to be manufactured.
[0226] The insertion element 730 shown in figure 16 is substantially the same as, and functions substantially similar to, the insertion element 630 of figure 15. The insertion element 730 includes three projections 758 extending upwardly from a horseshoe-shaped base 727 that includes a central opening 777 and that can be angled (or can include an angled surface) to fit adjacent to an inner wall or partition of a sterilizing biological indicator. Similar to the insertion element 630 of figure 15, the insertion element 730 includes a side wall 729 extending upwardly from the base 727 and from which the projections 758 extend. However, a difference between the insertion element 730 of figure 16 and the insertion element 630 of figure 15 consists in that the projections 758 each include an upper end 759 which is angled towards the center of the insertion element 730. These upper ends 759 can also be configured to angled or directed towards a container for a biological sterilization indicator and / or a center for a biological sterilization indicator.
[0227] The upper ends 759 can be configured to support a container and keep it above the fractured area between the 758 projections until the container is forced downward during activation. The upper ends 759 can function as a support 732. The insert 730 and particularly the support 732 can be adapted to hold or transport a container, so that the container is kept intact in a location separate from the spores during sterilization. In addition, the insertion element 730 and particularly the support 732 can be adapted to keep the container intact in a position on a biological sterilization indicator that maintains at least minimum spacing (for example, a minimum cross-sectional area of space) between the container and a compartment or wall of the sterilization biological indicator and / or between the container and any other components or structures in the compartment (for example, at least a portion of the insert element 730, such as support 732, etc.), for example, to maintain a substantially constant sterilizing path in the biological sterilization indicator. In some embodiments, the insert 730 can be adapted to hold the container in a substantially consistent location in the compartment.
[0228] As shown in figure 17, the upper ends 759 may also include a rounded surface to prevent premature rupture of a container, but the upper ends 759 also include a smaller area of contact with the container, which can both serve to prop the container away from a region of the sterilization biological indicator in which the spores are located and can work to concentrate the force on a smaller area of the container as the container is forced into the interior space of the insert 730 during activation . This concentration of force can increase the cracking / crushing pressure at these locations in the container, and can facilitate fracturing of the container in a desired and reliable manner.
[0229] The insertion element 830 illustrated in figure 17 is substantially the same as, and functions substantially similar to, the insertion element 530 of figure 14. The insertion element 830 includes two projections 858 extending upwardly from a horseshoe-shaped base 827 that includes a central opening 877 and that can be angled (or can include an angled surface) to fit adjacent to an inner wall or partition of a sterilizing biological indicator. In addition, each of the projections 858 includes at least one partially rounded or arcuate upper end 859. The upper ends 859 can function as a support 832. The insert 830 and particularly support 832 can be adapted to hold or transport a container , so that the container is kept intact in a location separate from the spores during sterilization. In addition, the insertion element 830 and particularly the support 832 can be adapted to keep the container intact in a position on a biological sterilization indicator that maintains at least minimum spacing (for example, a minimum cross-sectional area of space) between the container and a compartment or wall of the sterilization biological indicator and / or between the container and any other components or structures in the compartment (for example, at least a portion of the insert element 830, such as support 832, etc.), for example, to maintain a substantially constant sterilizing path in the biological sterilization indicator. In some embodiments, the insert 830 can be adapted to hold the container in a substantially constant location in the compartment.
[0230] A difference between insertion element 830 of figure 17 and insertion element 530 of figure 14 is that insertion element 830 includes one or more projections 861 positioned substantially perpendicular to a longitudinal direction of one biological sterilization indicator (for example, when the insert 830 is positioned on a biological sterilization indicator). These projections 861 are not angled downwards like the base 827. As a result, projections 861 can be used for a variety of purposes. For example, the projections 861 can stabilize the insertion element 830 (for example, holding the insertion element 830 in a desired position in a compartment of a biological sterilization indicator) under the fracture force of a container. In addition, protrusions 861 can function to retain and / or collect the fractured portions of the container after it has been fractured to inhibit the movement of these portions in the vicinity of the spores in the biological sterilization indicator, which could negatively affect spore growth and / or detection of spore growth. Other shapes and configurations of the 861 protrusions can be employed, which still allow the movement of fluid to the spores (for example, of liquid after it has been released from a frangible container) while inhibiting the movement of solids to the spores.
[0231] Although the biological sterilization indicators 100, 200, 300 and 400 and the insertion elements 530, 630, 730 and 830 are described as individual modalities, it should be understood that a biological sterilization indicator of the present description can include any combination of the various characteristics and elements described above and shown in figures 1 to 17 that performs the functions of the biological sterilization indicator. For example, insertion elements 230, 330, 430, 530, 630, 730, and 830 are illustrated and generally described as configured to be in a boundary position with wall 218, 318, 418, etc. in a biological sterilization indicator to provide the strength to fracture the respective container 220, 320, 420, etc. However, it should be understood that a connector, such as connector 134 shown in figures 1 to 5 and equivalents thereof, can be used with any of the other insertion elements 230, 330, 430, 530, 630, 730, and 830 for allowing at least a portion of the insertion element such as support 232, 332, 432, 532, 632, 732 and 832 to move relative to the sterilization biological indicator compartment.
[0232] The modalities described above and illustrated in the figures are presented by way of example only and are not intended to limit the concepts and principles of this description. Consequently, it will be appreciated by one skilled in the art that various changes to the elements and their configurations and arrangements are possible without departing from the spirit and scope of this description. Various features and aspects of the present description are demonstrated in the following claims.

权利要求:
Claims (15)
[0001]
1. BIOLOGICAL STERILIZATION INDICATOR (100), characterized by comprising: a compartment (102) that includes a first portion (104), and a second portion (106) adapted to be coupled to the first portion (104), the second being portion (106) is movable with respect to the first portion (104) between a first position (148) and a second position (150); a container (120) comprising a liquid (122), with at least a portion of the container (120) being frangible, the container (120) being positioned in at least the first portion (104) of the compartment (102) ; a spore reservoir (103) in the compartment (102); and a projection (156) positioned in the compartment (102), the projection (156) being configured to (a) keep the container (120) intact in a location in the compartment (102) in which an area in minimum cross section of space between the container (120) and at least one between the compartment (102) and the projection (156) is maintained when the second portion (106) of the compartment (102) is in the first position (148), and (b) fractures the container (120) when the second portion (106) is moved from the first position (148) to the second position (150); wherein the first portion (104) of the compartment (102) includes at least one flat wall (108) positioned adjacent to the spore reservoir (103), and where at least one flat wall (108) includes a detection (167).
[0002]
2. BIOLOGICAL STERILIZATION INDICATOR (100), characterized by comprising: a compartment (102) that includes a first portion (104), and a second portion (106) adapted to be coupled to the first portion (104), the second being portion (106) is movable with respect to the first portion (104) between a first position (148) and a second position (150); a container (120) comprising a liquid (122), with at least a portion of the container (120) being frangible, the container (120) being positioned at least in the first portion (104) of the compartment (102); a spore reservoir (103) in the compartment (102); a support (132) positioned to keep the container (120) intact at a location in the compartment (102) when the second portion (106) of the compartment (102) is in the first position (148), the support (132) being positioned to allow movement of the container (120) in response to movement from the second position (150) of the compartment (102) between its first position (148) and the second position (150); and a projection (156) positioned to fracture the container (120) when the second portion (106) of the compartment (102) is moved from the first position (148) to the second position (150), the support (132) being positioned to maintain at least one area in minimum cross section of space between the container (120) and at least one between the compartment (102), the support (132) and the protrusion (156), in which the first portion (104) The compartment (102) includes at least one flat wall (108) positioned adjacent to the spore reservoir (103), and in which at least one flat wall (108) includes a detection window (167).
[0003]
3. INDICATOR (100), according to any one of claims 1 to 2, characterized in that the projection (156) is positioned to provide a constant trajectory of sterilizer (164) in the biological sterilization indicator (100), with the trajectory of The sterilizer (164) is positioned to provide fluid communication between the environment and the spore reservoir (103) during the sterilization procedure.
[0004]
4. INDICATOR (100) according to any one of claims 1 to 3, characterized in that the projection (156) is provided by a first portion of an insertion element (130), and the insertion element (130) includes additionally a second portion including the spore reservoir (103).
[0005]
INDICATOR (100) according to claim 4, characterized in that the first portion of the insertion element (130) and the second portion of the insertion element (130) are separated.
[0006]
6. INDICATOR (100) according to claim 4, characterized in that the first portion of the insertion element (130) and the second portion of the insertion element (130) are unitary.
[0007]
INDICATOR (100) according to any one of claims 2 to 6, characterized in that the support (132) and the projection (156) are provided by an insertion element (130), wherein the insertion element (130) includes a first portion that includes the support (132), a second portion that includes the spore reservoir (103), and a third portion that includes the protrusion (156).
[0008]
8. INDICATOR (100), according to claim 7, characterized in that the first portion of the insertion element (130) is positioned towards a first end (101) of the compartment (102), the second portion of the insertion element being the insert (130) is positioned towards a second end (105) of the compartment (102), and the third portion of the insertion element (130) is immediately positioned the first portion and the second portion of the insertion element (130) ).
[0009]
9. INDICATOR (100) according to any one of claims 2 to 8, characterized in that the support (132) and the projection (156) are provided by an insertion element (130), and the insertion element (130) ) additionally includes a spore reservoir (103).
[0010]
10. INDICATOR (100) according to claim 9, characterized in that the support (132) is movable between a first position in which the container (120) is not fractured and a second position in which the container (120) is fractured.
[0011]
11. INDICATOR (100), according to claim 10, characterized in that the insertion element (130) additionally includes a connector (134) positioned to allow the movement of the support (132) between the first position (148) and the second position (140).
[0012]
12. INDICATOR (100) according to claim 11, characterized in that the connector (134) includes a hinge (135).
[0013]
13. INDICATOR (100) according to any one of claims 2 to 12, characterized in that the support (132) includes at least one arm (142) positioned to keep the container (120) intact when the second portion (106) of the compartment (102) is in the first position (148), where at least one arm (142) is movable with respect to the container (120) when the second portion (106) of the compartment (102) moves between the first portion and the second portion.
[0014]
14. INDICATOR (100) according to claim 13, characterized in that the first portion (104) of the compartment (102) includes a length, and a tapered portion (146) in which an internal area in cross section of the first portion (104) ) of the compartment (102) decreases over at least a portion of its length, and the at least one arm (142) is movable between a first position (148) in which the container (120) is not fractured and a second position (150) in which the container (120) is fractured in response to movement of the container (130) in the tapered portion (146) of the first portion (104) of the compartment (102).
[0015]
15. INDICATOR (100) according to claim 14, characterized in that the container (120) is moved in the tapered portion (146) of the first portion (104) of the compartment (102) in response to the movement of the second portion (106) of the compartment (102) between the first position (148) and the second position (150).

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法律状态:
2020-08-25| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-09-01| B15K| Others concerning applications: alteration of classification|Free format text: AS CLASSIFICACOES ANTERIORES ERAM: C12Q 1/22 , A61L 2/28 Ipc: A61L 2/28 (2006.01) |

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2020-09-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-08| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2021-01-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-30| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 30/03/2021, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/07/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |

优先权:

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申请号 | 申请日 | 专利标题

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US22693709P| true| 2009-07-20|2009-07-20|

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US61/226,937|2009-07-20|

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PCT/US2010/041010|WO2011011189A1|2009-07-20|2010-07-06|Biological sterilization indicator and method of using same|

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