Built-in Biological Indicators

Abstract

To provide a method for using a biological sterilization indicator.SOLUTION: A method comprises providing the biological sterilization indicator, the biological sterilization indicator comprising: (i) an ampoule containing a liquid growth medium; and (ii) an insert member disposed at least partially within a first enclosure of the biological sterilization indicator, the insert member having: a platform comprising a top surface, an abutment surface, and a side surface; a first cavity disposed through the platform and configured to allow passage of a first volume of the liquid growth medium into a second enclosure; and a second cavity that is an angled cut through at least a portion of the side surface and is configured to allow passage of a second volume of the liquid growth medium into the second enclosure.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The subject matter disclosed herein relates to a built-in biological sterilization indicator. [Background technology]

[0002] Medical devices are typically sterilized before use to minimize the possibility that a contaminated device that could cause an infection in a subject may be used on the subject. Various sterilization techniques may be used, such as steam, hydrogen peroxide, and vapor phase sterilization, with or without gas plasma and ethylene oxide (EtO). Each of these methods depends to some extent on the diffusion rate of the sterilizing fluid, usually a gas, depending on the medical device being sterilized.

[0003] Prior to sterilization, medical devices are typically packaged in containers or pouches with a semipermeable barrier that allows the passage of a sterilizing fluid—sometimes called a sterilant—but prevents the entry of contaminating microorganisms, particularly after sterilization, until the package is opened by medical personnel. In an effective sterilization cycle, contaminating microorganisms within the package must be killed, as any microorganisms that survive the sterilization cycle can multiply and recontaminate the medical device.

[0004] While packaging helps prevent contamination of sterile medical devices, it can increase the difficulty of achieving a successful sterilization cycle because the packaging prevents the sterilant from reaching the device or instrument contained within. This is particularly problematic for devices and instruments that have diffusion-restricted spaces within them, because these diffusion-restricted spaces reduce the likelihood that a sterilization cycle can be effective. For example, endoscopes typically have long, narrow lumens through which the sterilant must diffuse in sufficient concentration for sufficient time to achieve a successful sterilization cycle.

[0005] Confirming that a sterilization cycle was effective helps medical personnel avoid using contaminated medical devices on subjects. Typically, sterilized medical devices do not themselves check for microbial contaminants, because such activity could introduce other microbial contaminants into the medical device, thereby recontaminating the device. Thus, indirect checks have been developed in the form of sterilization indicators.

[0006] A sterilization indicator is a device that may be placed alongside or adjacent to a medical device that is placed in a sterilization cycle, so that the sterilization indicator undergoes the same sterilization cycle as the medical device. For example, a biological indicator having a predetermined amount of microorganisms with known resistance to the sterilant may be placed in a sterilization chamber along with the medical device and subjected to a sterilization cycle. After the cycle is complete, the microorganisms in the biological indicator can be cultured to determine if any of the microorganisms survived the cycle.

[0007] Certain biological indicators are referred to as "self-contained." These indicators typically include a housing containing a microbial load and a source of growth medium in a fragile container placed near the microorganisms. Like other biological indicators, "self-contained" biological indicators ("SCBIs") may undergo a sterilization cycle along with the medical device. After the cycle, the fragile container can be broken to release the growth medium and culture any surviving microorganisms in situ. The SCBI can be incubated at elevated temperatures, typically about 50°C to 60°C, which promotes the growth of surviving microorganisms. Incubation using commercially available products typically lasts for about 24 hours. During this time, it is desirable for medical personnel not to use the medical device while the effectiveness of the sterilization remains unconfirmed. This can lead to inventory inefficiencies for healthcare providers, such as hospitals. This could result in the medical device having to be stored while unavailable, potentially requiring healthcare providers to stock more medical devices than they otherwise would need to ensure an adequate supply of medical equipment. Alternatively, healthcare providers could use the medical device before the incubation is complete and the effectiveness of the sterilization is confirmed. However, using a medical device before sterilization efficacy has been confirmed may expose the subject of the medical procedure to the risk of infection from the medical device.

[0008] After incubation, the SCBI is analyzed to detect the presence of microorganisms. If microorganisms are detected, the sterilization cycle is considered ineffective. If no microorganisms are detected, the sterilization cycle is considered effective. Some SCBIs are designed to contain a growth medium that changes color in the presence of microorganisms. This color change can be due to a pH shift caused by acid production by live microorganisms metabolizing the growth medium, which also contains a pH indicator dye. Other SCBIs are designed to contain a growth medium containing a fluorescent substance whose fluorescence depends on the amount of viable microorganisms contained in the medium. In these SCBIs, a change in color or amount of fluorescence indicates the ability to grow viable microorganisms during incubation.

[0009] The fragile containers of SCBIs that contain the liquid growth medium are often manufactured from glass. The glass must be sturdy enough to prevent breakage during transport, for example, from the SCBI manufacturer to the healthcare provider. However, such sturdyness equates to greater force required by healthcare personnel to break the ampule in the desired amount of time. Therefore, some SCBI manufacturers provide actuators to hospital personnel to assist them in breaking the ampule.

[0010] The microorganisms in SCBIs are often placed on a carrier. Carriers can be made from a variety of materials, such as paper or fiberglass. If elements in the SCBI, such as fragile containers, are not restrained from contacting the carrier, the carrier may be damaged, particularly during transport. For example, during transport, fragile containers may be bumped around in the SCBI, causing the fragile containers to repeatedly strike the carrier and damage it. Such damage may increase the likelihood that the carrier may become dislodged from the location where it must be located for the SCBI to function properly.

[0011] The color or turbidity change of the liquid growth medium of the SCBI can be determined visually by an individual healthcare professional without the aid of an automated device. Alternatively, the color, turbidity, or fluorescence change can be determined with the aid of a color and / or fluorescence sensor integrated into the automated device. The accuracy of such determinations can be reduced by the presence of debris from the original fragile container containing the growth medium, as these debris can block or partially obstruct the optical path between the SCBI and the sensor or they can alter the wavelength of light or the amount of fluorescence from the SCBI that the sensor can detect. Furthermore, debris can prevent the entire required volume of growth medium from contacting the carrier because the debris can contact the carrier and thereby provide an obstacle between the growth medium and the carrier. Debris can also create a small volume containing, for example, air, gas, and vapor, which may be necessary for a sufficient volume of growth medium to travel to reach the carrier. Summary of the Invention [Means for solving the problem]

[0012] In some embodiments, a biological sterilization indicator is disclosed, which includes a housing having a first enclosure and a second enclosure, an ampoule containing a liquid growth medium, and an insert member at least partially disposed in the first enclosure. In some embodiments, a portion of the ampoule is disposed within the first enclosure, and no ampoule is disposed within the second enclosure. In some embodiments, the insert member includes a platform having a top surface, an abutment surface, and a side surface. In some embodiments, the insert member has a first cavity disposed on the platform and configured to allow a first amount of liquid growth medium to pass into the second enclosure. In some embodiments, the insert member has a second cavity disposed through at least a portion of the side surface and configured to allow a second amount of liquid growth medium to pass into the second enclosure. In some embodiments, the second cavity of the insert member may be an angled notch passing through the abutment surface and the side surface. In some embodiments, the angled notch may be disposed entirely below the top surface. In some embodiments, the insert member further includes a wall disposed on the top surface of the platform. In some embodiments, the wall has a cylindrical shape.

[0013] A biological sterilization indicator, particularly one configured according to at least some of the embodiments described in the preceding paragraph, can be used to perform a method including providing a biological sterilization indicator, breaking the ampoule, allowing a first amount of liquid growth medium to pass through the first cavity, and allowing a second amount of liquid growth medium to pass through the second cavity, the method further including preventing the formation of a liquid lock.

[0014] In some other embodiments, a biological sterilization indicator is disclosed, including a housing, an ampoule, a cap, a carrier, and an insert. In some of these embodiments, the housing has an interior sidewall, an interior bottom wall, a first enclosure, a second enclosure, and a support for the interior sidewall, with the first enclosure disposed above the support and the second enclosure disposed between the interior bottom wall and the support. In some of these embodiments, the ampoule has a first end and a second end, and at least a portion of the ampoule is disposed within the first enclosure. In some of these embodiments, the cap has an inner surface and an outer surface, and the cap is disposed on a portion of the housing that includes at least a portion of the first enclosure. In some of these embodiments, the carrier is disposed on the interior bottom wall. In some of these embodiments, the insert has a platform, which includes an upper surface and an abutment surface. In some of these embodiments, the second end of the ampoule is disposed on the upper surface, and the abutment surface is disposed on the support. In some of these embodiments, the insert has legs extending toward the interior bottom wall. In some of these embodiments, the legs have a length that is shorter than the distance between the support and the interior bottom wall, resulting in a gap between the support and the legs. In some of these embodiments, the length of the legs is approximately 0.1 to 2 millimeters shorter than the distance between the support and the interior bottom wall. In some of these embodiments, the top surface of the platform includes at least three stress concentrators, and the second end of the ampoule contacts each of the at least three stress concentrators. In some of these embodiments, the ampoule is disposed within an annular protrusion that originates on the inner surface of the cap and extends toward the second enclosure of the housing. In some of these embodiments, the first end of the ampoule connects to the annular protrusion via a friction fit. In some of these embodiments, the ampoule has an annular cross-section with an outer diameter that is approximately 0.1 to 1 millimeter shorter than the inner diameter of the annular protrusion. In some of these embodiments, the inner surface of the cap contacts the first end of the ampoule.

[0015] In yet another embodiment, a biological sterilization indicator is disclosed, comprising a housing, an ampoule, a cap, and an insert. In some of these embodiments, the housing has a first wall containing a first enclosure, a second enclosure, and a support disposed between the first and second enclosures. In some of these embodiments, the ampoule has a first end and a second end, and at least a portion of the ampoule is disposed within the first enclosure. In some of these embodiments, a cap is disposed on a portion of the housing including at least a portion of the first enclosure, and the cap has an inner surface and an outer surface. In some of these embodiments, the cap has an insert having a platform disposed on the support. In some of these embodiments, the insert has a first stress concentrator, a second stress concentrator, and a third stress concentrator. In some of these embodiments, each stress concentrator is disposed on the platform, each contacting the second end of the ampoule. In some of these embodiments, the insert further comprises a second wall beginning on the platform and extending away from the second enclosure.

[0016] In yet another embodiment of the present invention, the biological sterilization indicator includes at least a first stress concentrator, a second stress concentrator, and a third stress concentrator, each having a triangular shape including a base, a height, and a hypotenuse. In some of these embodiments, each base contacts the platform, each height contacts the second wall, and each hypotenuse contacts the second end of the ampoule. In some of these embodiments, the angle between the platform and the hypotenuse of the first stress concentrator is different from the angle between the platform and the hypotenuse of the second stress concentrator. In some of these embodiments, the angle between the platform and the hypotenuse of the first stress concentrator is different from the angle between the platform and the hypotenuse of the third stress concentrator, and the angle between the platform and the hypotenuse of the second stress concentrator is different from the angle between the platform and the hypotenuse of the third stress concentrator. In some of these embodiments, the angle between the platform and the hypotenuse of the second stress concentrator is within about 5 degrees of the angle between the platform and the hypotenuse of the third stress concentrator. In some of these embodiments, the angle between the platform and the hypotenuse of the second stress concentrator is equal to the angle between the platform and the hypotenuse of the third stress concentrator.

[0017] In further embodiments of still other embodiments, the insert member further includes a second wall originating on the platform and extending away from the second enclosure, and the cap is movable from the first position to the second position. In some of these embodiments, the cap includes a protrusion originating at an inner surface of the cap and extending toward the insert member. In some of these embodiments, the cap includes an arm originating at the second wall and extending toward the cap, such that the arm is adapted to prevent movement of the cap by interference with the protrusion. In some of these embodiments, the arm is adapted to move from a first orientation to a second orientation to allow movement of the cap to the second position. In some of these embodiments, the arm includes an opening therethrough. In some of these embodiments, the protrusion is adapted to move from a third orientation to a fourth orientation. In some of these embodiments, the arm is positioned relative to the protrusion such that the ampoule is positioned to prevent bending of the protrusion from the third orientation to the fourth orientation. In some of these embodiments, the arm is positioned relative to the protrusion such that the ampoule is positioned to prevent bending of the arm from a first orientation to a second orientation.

[0018] A biological sterilization indicator, particularly one configured according to at least some of the embodiments described in the previous two paragraphs, can be used to carry out a method comprising exerting an applied force on the biological sterilization indicator and generating at least five counter forces at distinct locations on the ampoule.

[0019] As used herein, the term "surface" should be understood as the features that form the boundary of an object.

[0020] As used herein, the term "wall" should be understood as a feature of an object that forms at least part of the side, top or side of the object. A wall is an example of a surface.

[0021] As used herein, the term "abutment surface" should be understood as the surface of an object that contacts another object.

[0022] As used herein, the term "enclosure" should be understood as a space or cavity within an object that is defined at least in part by a surface of the object or a surface of another object contained therein.

[0023] As used herein, the term "insert member" should be understood as an object that is placed within one or more enclosures of an object.

[0024] As used herein, the term "cavity" should be understood as a feature of an object that is devoid of solid material and is defined by at least a portion of one surface or wall of the object. A cavity can provide a passageway through the object. A cavity can be used to maintain fluid communication through or around the object.

[0025] As used herein, the term "liquid lock" should be understood as an obstruction in the path of a quantity of flowing liquid, the obstruction being formed at least in part by a quantity of stationary gas and / or liquid.

[0026] As used herein, the term "inhibit" should be understood as reducing the likelihood of an undesirable outcome, such as the formation of a liquid lock, occurring.

[0027] As used herein, the term "notch" should be understood as a type of cavity created or as if created by removing material from an object. Examples of notches include features such as small grooves and bevels.

[0028] As used herein, the term "support" should be understood as a feature that helps maintain the position of another feature or object.

[0029] As used herein, the term "leg" should be understood as an elongated member that originates at and extends away from another feature of the object.

[0030] As used herein, the term "carrier" must be understood as the object on which the microorganisms and / or enzymes are placed.

[0031] As used herein, the term "applied force" should be understood as a force exerted by a user directly or indirectly on an object, with or without the aid of another object or device.

[0032] As used herein, the term "reaction force" should be understood as a force generated by an object subjected to an applied force that corresponds to an applied force, where at least a component of the reaction force points in a direction opposite to the direction of the applied force.

[0033] As used herein, the term "stress concentration portion" should be understood as a feature including a surface area configured to exert a reaction force on an object receiving an applied force, and exerted directly or indirectly on the object, where the surface area configured to exert the reaction force is smaller than the surface area of ​​the object against which the applied force is exerted.

[0034] As used herein, the term "protrusion" should be understood as a feature of an object that originates at and extends away from the surface of the object.

[0035] As used herein, the term "annular" should be understood to indicate that the feature has a cross section that is at least partially elliptical and / or circular.

[0036] As used herein, the term "friction fit" should be understood as an interlocking relationship between two or more surfaces that is achieved by friction.

[0037] As used herein, the term "arm" should be understood as an elongated member of an object that originates at and extends away from another feature of the object.

[0038] As used herein, the term "impede" should be understood as causing at least a partial or temporary impediment to movement.

[0039] As used herein, the term "bending" should be understood as the bending action that occurs in a bendable object or feature caused by the application of a deflecting force to the object or feature.

[0040] As used herein, the term "orientation" should be understood as the angular attitude of an object or feature.

[0041] The biological sterilization indicators disclosed herein reduce the amount of force required to break the ampoule by depressing the cap, while being robust enough to survive shipping without breaking the ampoule or degrading the carrier. The biological sterilization indicators disclosed herein help prevent artifacts, such as pieces of a broken glass ampoule, from entering the second enclosure of the housing, thereby preventing such artifacts from introducing errors into the determination of the color or fluorescence of the growth medium. The biological sterilization indicators disclosed herein help prevent the formation of blockages in such artifacts that can prevent the desired amount of growth medium from contacting the carrier. [Brief explanation of the drawings]

[0042] While this specification concludes with claims that particularly and distinctly claim the subject matter described herein, it is believed that the subject matter will be better understood from the following description of specific examples read in conjunction with the accompanying drawings, in which like reference numerals indicate the same elements. [Figure 1]FIG. 1 shows a side view of a first example embodiment of a SCBI. [Figure 2] 2 shows an isometric exploded view of the first example SCBI shown in FIG. 1. [Figure 3] 1A-1C show cross-sectional views of the first example SCBI shown in FIGS. 1-2 taken along line AA in FIG. [Figure 4] 4 shows an isometric view of a first example embodiment of the insertion member of the first example SCBI shown in FIGS. 1-3. [Figure 5] 5 shows a plan view of a first example embodiment of the insert member of FIG. 4. [Figure 6] 6 shows a cross-sectional view of a first example embodiment of the insert member of FIGS. 4-5 taken along line BB in FIG. 5. [Figure 7] 1 shows an isometric view of a second example embodiment of a SCBI. [Figure 8] 8 illustrates an isometric view of a second example embodiment of the insertion member of the second example SCBI shown in FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0043] The following description sets forth certain illustrative examples of the claimed subject matter. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description. Accordingly, the drawings and description are to be regarded as illustrative in nature.

[0044] I. Built-in Biological Indicators 1-3, a self-contained biological indicator ("SCBI") 100 is shown. The SCBI 100 includes a housing 102 and a cap 104. The cap 104 includes an inner surface 106, an outer surface 108, and a protrusion 112 that may be flat, beveled, arcuate, circular, conical, or some combination thereof. The cap 104 may further include one or more perforations 110 to facilitate the passage of gas (e.g., air or sterilant) into or out of the SCBI. A chemical indicator 196, which may be a sticker that changes color upon exposure to a sterilant, may be affixed to the cap. The inner surface 106 may further include a curved portion 156. The housing 102 includes a side wall 114 having an inner side wall 116 and an outer side wall 118, and a bottom wall 120 having an inner bottom wall 122 and an outer bottom wall 126. The housing 102 further includes a support 130 formed by compression of the side wall 114. A top end 134 of the housing 102 may be opposite the bottom wall 120, thereby defining an opening 132. The housing 102 may be further defined by a top portion 124 and a bottom portion 128 having a support 130 disposed between the top and bottom portions, further defining a first enclosure 136 and a second enclosure 138 within the housing 102. As is well known in the art of SCBIs, the cap 104 is disposed relative to the housing 102 in a first position and is configured to be movable from the first position to a second position. In the first position (shown in FIGS. 1 and 3 ), the cap 104 couples to the housing 102 to allow gas (e.g., air or sterilant) to move from the ambient environment into the SCBI, or vice versa. In this position, optional through-hole 110 of cap 104 is positioned above top end 134, such that first enclosure 136 and second enclosure 138 are in fluid communication with the ambient environment, thereby allowing the introduction and withdrawal of sterilant into and out of first enclosure 136 and second enclosure 138 via through-hole 110. Cap 104 can be pressed against housing 102 into the second position.In this second position, the through hole 110 is positioned below the top end 134 with the cap 104 and outer side wall 118 in a tight-fitting relationship, which blocks the through hole 110 and effectively seals the first enclosure 136 and the second enclosure 138 from the surrounding environment.

[0045] The SCBI 100 also includes a source of microorganisms or active enzymes, such as a carrier 140 impregnated with bacterial spores, other forms of bacteria (e.g., nutrients), and / or active enzymes. Spores from Bacillus, Geobacillus, and Clostridium species are often used to monitor sterilization processes utilizing saturated steam, hydrogen peroxide, dry heat, gamma irradiation, and ethylene oxide. Thus, the carrier 140 may be impregnated with spores from Bacillus, Geobacillus, and / or Clostridium species. The carrier 140 may be bibulous and formed from filter paper. Sheet-like materials such as cloth, nonwoven polypropylene, rayon, or nylon, and microporous polymeric materials may also be used. Nonbibulous materials such as metal (e.g., aluminum or stainless steel), glass (e.g., glass beads or fiberglass), porcelain, or plastic are also suitable for use. Moreover, the carrier 140 may be made from a combination of the above-mentioned materials. In some embodiments, the carrier 140 rests on the interior bottom wall 122. In some embodiments, the carrier 140 can have a thickness of about 0.1 to 0.5 millimeters.

[0046] The SCBI 100 also includes a frangible glass ampoule 142 having a first end 143 and a second end 144. The ampoule 142 can contain a liquid growth medium. The growth medium should be capable of promoting the growth of any viable microorganisms disposed on the carrier 140 by incubation. In some embodiments, the growth medium does not promote the growth of contaminating microorganisms, for example, not intentionally disposed on the carrier 140, because such contaminants may cause color or fluorescence changes that could lead to an inaccurate determination of sterilization effectiveness. The ampoule 142 can also include a growth indicator, either within the growth medium or separately. The growth indicator can be an enzyme or a dye, such as a fluorescent dye, that is useful for detecting the growth of viable microorganisms. The growth indicator can also be an enzyme-substrate system, which can be a substrate or mixture of substrates that an enzyme can act on and convert to an enzyme-modified product or products. For example, the enzyme-substrate system can be a fluorescent substrate that emits fluorescence distinct from the enzyme-modified product produced by the reaction between the enzyme and the fluorescent substrate. In some embodiments, the fluorescent substrate is little, if any, fluorescent and the enzyme-modified product is significantly more fluorescent than the substrate.

[0047] SCBI 100 can also include an insert member 146, which is shown in detail in FIGS. 3-6. Insert member 146 can include a platform 148 having a top surface 150, an abutment surface 152, a bottom surface 153, and one or more side surfaces, such as a lower surface 154 and an upper surface 155. Insert member 146 can also include a tubular wall 164 on platform 148 that originates from top surface 150 and / or side surface 154 and extends away from abutment surface 152. Tubular wall 164 can have a hollow cylindrical shape. The diameter of this cylinder must be larger than the diameter of ampoule 142 so that second end 144 can be positioned within tubular wall 164.

[0048] A first cavity (or passage) 178 may be disposed through the platform 148. The first cavity 178 may have the form of a hole that begins at the top surface 150 and terminates at the bottom surface 153. A second cavity (or passage) 188 may additionally or alternatively be disposed through the platform 148. The second cavity 188 may have the form of an angled cut (e.g., a chamfer or bevel) that begins at least partially at the side surface 154 and terminates at least partially at the abutment surface 152. Although not shown, the cavity 188 may additionally traverse the top surface 150. The insert member 146 may include additional instances of the cavity 178 and the cavity 188. For example, in some embodiments, three instances of the cavity 188 are disposed through the platform 148, from the upper side surface 155 to the abutment surface 152.

[0049] The insert member 146 may also include a leg (or legs) 166 originating from the bottom surface 153 and extending away from the platform 148. The leg 166 has a maximum length equal to the distance between the support 130 and the interior bottom wall 122 of the housing 102. As shown in FIG. 3 , the leg 166 has a length somewhat less than the distance between the support 130 and the interior bottom wall 122 of the housing 102. The leg 166 may have a length approximately 0.1 to 1 millimeter less than the distance between the support 130 and the interior bottom wall 122 of the housing 102. The insert member 146 may include multiple instances of the leg 166. For example, the insert member 146 may include three instances of the leg 166.

[0050] The insert member 146 can also include a protrusion or stress concentrator 170 disposed on the top surface 150 of the platform 148. For example, the stress concentrator 170 can have a wedge shape, such as a rounded ridge, an angled ridge, or a triangular wedge. As shown in FIGS. 3-6 , the stress concentrator 170 has a triangular wedge shape. The triangular wedge can have a right-angled triangle shape including a base portion 171, a height portion 172, and a hypotenuse portion 173. The base portion 171 can be coincident with the top surface 150, and the height portion 172 can be coincident with the upper side surface 155 and / or the tubular wall 164. In such an embodiment, the stress concentrator 170 can function as a gusset that can strengthen the bond between the tubular wall 164 and the platform 148. The base portion 171 can be disposed at a first angle α relative to the hypotenuse portion 173. The first angle α can be an acute angle. The first angle may have a value between 45° and 85°.

[0051] Insert 146 may further include multiple stress concentrators. For example, in addition to stress concentrator 170, it may also include stress concentrator 180 and stress concentrator 190. Like stress concentrator 170, stress concentrator 180 and stress concentrator 190 may each have a rounded ridge, an angled ridge, or a wedge shape, such as a triangular wedge. As shown in FIGS. 3 and 5 , stress concentrator 180 has a triangular shape and includes a base portion 181, a height portion 182, and a hypotenuse portion 183. Stress concentrator 190 also has a triangular shape including a base portion 191, a height portion 192, and a hypotenuse portion 193. Base portion 181 may be disposed at a second angle β relative to hypotenuse portion 183, and base portion 191 may be disposed at a third angle γ relative to hypotenuse portion 193. The second and third angles may be acute angles. The second and third angles may have values ​​between 45° and 85°. The second angle and the third angle may be equal to each other and to the first angle. The second angle and the third angle may be equal to each other but different from the first angle. The first angle, the second angle, and the third angle may each be different from each other. The insert member 146 can be assembled as an assembly of multiple elements or can be manufactured as a single element, for example by injection molding.

[0052] Insert member 146 is disposed within SCBI 100. Specifically, abutment surface 152 of platform 148 rests on or abuts support 130. Thus, abutment surface 152 and support 130 together define a boundary between first enclosure 136 and second enclosure 138 of housing 102. Leg or legs 166 therefore extend into second enclosure 138 to help maintain the position of carrier 140, which rests on interior bottom wall 122 and should remain there throughout the life of the SCBI. However, because leg or legs 166 are shorter than the distance between support 130 and interior bottom wall 122, they do not contact interior bottom wall 122. Preferably, carrier 140 is thin enough so that a gap is maintained between leg or legs 166 and carrier 140. Such clearance should help prevent damage to the carrier 140 that may occur during transportation of the SCBI from the manufacturer's manufacturing facility to, for example, a warehouse or healthcare facility. Such transportation may be performed, for example, by an agent or employee of the manufacturer or by a carrier (e.g., the U.S. Postal Service, United Parcel Service). During transportation, possibly including ground transportation, including by ground transportation vehicle such as a truck or train, the SCBI may be subjected to repeated jostling caused, for example, by road or train track impacts. This jostling may cause damage to the carrier 140 if the leg or legs 166 may come into contact with the carrier 140. In such cases, the jostling may cause, for example, the leg or legs 166 to repeatedly strike the carrier 140, thereby causing wear on the carrier 140 at any contact points. In the worst case, the wear may be sufficient to create a hole in the carrier 140. Therefore, to help prevent such damage, a clearance of approximately 0.1 to 0.4 millimeters should be present between the leg or legs 166 and the carrier 140. Thus, after the SCBI 100 is manufactured, it can be loaded onto a standard shipping vehicle, such as a truck, and the vehicle can be driven to a destination, such as a healthcare facility or warehouse, to transport the SCBI 100 to its destination.Destination personnel may refrain from inspecting SCBI 100 for damage to carrier 140 based on increased assurance that carrier 140 is less likely to be damaged during transport. In an alternative embodiment, legs 166 may include retaining protrusions thereon, such as rings that connect to the legs, the rings having a diameter equal to or approximately equal to the diameter or width of carrier 140. The retaining protrusions may be spaced up to 0.4 mm from carrier 140, or they may contact carrier 140 at the outer edge of carrier 140.

[0053] The position of glass ampoule 142 is maintained within SCBI 100 by insert member 146 and cap 104 in their first positions, such that ampoule 142 does not contact housing 104. Curved portion 156 may assist in maintaining the position of ampoule 142. As shown in FIGS. 1 and 3 , a portion of ampoule 142 is disposed within first enclosure 136, and a portion of ampoule 142 is disposed above top end 134 of housing 102 but within cap 104. In first enclosure 136, second end 144 of glass ampoule 142 rests on platform 148 or any one or more of stress concentrators 170, 180, and 190, such that second end 144 is disposed within tubular wall portion 164 of insert member 146. Second end 144 of glass ampoule 142 can contact first point stress concentration portion 170, second point stress concentration portion 180, and third point stress concentration portion 190. First end 143 of ampoule 142 is disposed within cap 104. In some embodiments, first end 143 of ampoule 142 contacts inner surface 106 of cap 104, and in some embodiments, curved portion 156, such that glass ampoule 142 is restrained from moving up and down by its contact with cap 104 and insert 146. In some embodiments, first end 143 of ampoule 142 can also be disposed within protrusion 112.

[0054] Protrusion 112 may be configured to form a tight fit with ampoule 142. If protrusion 112 is ring-shaped, protrusion 112 may have a diameter similar to or equal to the diameter of ampoule 142. Thus, there may be a friction fit between ampoule 142 and protrusion 112. Alternatively, the diameter of protrusion 112 may be slightly larger than the diameter of ampoule 142 to provide a gap of approximately 0.1 mm to 3 mm between ampoule 142 and protrusion 112.

[0055] By constraining the position of ends 143 and 144 of ampoule 142, the overall position of ampoule 142 can be maintained within SCBI 100 until a user desires to use the SCBI, which can help prevent premature breakage of glass ampoule 142, particularly during transport from a manufacturing facility to another location, such as a healthcare facility.

[0056] During use, SCBI 100 undergoes a sterilization cycle, preferably along with a medical device that has been sterilized by the sterilization cycle. After the sterilization cycle, the user activates SCBI 100 by applying a force to cap 104 using the user's hand or other body part and / or with the assistance of a device suitable for helping the user apply force to cap 104. Cap 104, and in some embodiments, curved portion 156, applies at least a portion of the force exerted by the user on cap 104 to ampoule 142, which creates a reaction force between cap 104 and top end 143. Ampoule 142, via bottom end 144, applies at least a portion of the force exerted by the user on cap 104 to stress concentration portions 170, 180, and 190 of insertion member 146, which in turn creates a reaction force between bottom end 143 and stress concentration portions 170, 180, and 190 of insertion member 146. Insertion member 146, via support 130, applies at least a portion of the force a user applies to cap 104 to abutment surface 152, which generates a reaction force between abutment surface 152 and support 130. Ampoule 142 made of glass will shatter into glass shards when the force a user applies to cap 104 creates a stress within ampoule 142 greater than ampoule 142 can withstand. Stress concentrating portions 170, 180, and 190 serve to increase the stress within ampoule 142 for a given force a user applies directly to cap 104 and indirectly to ampoule 142 because the surface area of ​​contact between bottom end 144 of ampoule 142 and stress concentrating portions 170, 180, and 190 is less than the surface area of ​​cap 104 where the user applies force to activate the SCBI and / or is less than the surface area of ​​contact between cap 104 and top end 143 of ampoule 142, which may include curved portion 156.

[0057] Once broken, ampoule 142 is no longer present to resist force applied to the cap by a user. Thus, force applied by the user moves cap 104 to the second position where the cap effectively seals SCBI 100. Insert 146 prevents glass shards from entering second enclosure 138, causing some glass shards to fall onto platform 148 and remaining glass shards to fall onto other glass shards.

[0058] Breaking the ampoule 142 also releases some amounts of the liquid growth medium, which flows downward through the debris and through the cavity 178, eventually collecting in the second enclosure 138. Other amounts of the liquid growth medium spurt toward the interior sidewall 116 of the housing 102. Some of these amounts impact the interior sidewall 116 and then flow downward, passing through the gap between the interior sidewall 116 and the insert 146, eventually collecting in the second enclosure 138.

[0059] Cavities 178 and 188 provide openings through which fluids, such as growth medium, gas (e.g., air), steam, and sterilant, can flow. These openings function as passageways that help maintain fluid communication within housing 102 between first enclosure 136 and second enclosure 138. Specifically, cavity 178 helps maintain fluid communication through insert member 146, and cavity 188 helps maintain fluid communication along the side of insert member 146 between wall 164 and interior sidewall 116 of housing 102.

[0060] Cavities 178 and 188 can further facilitate the flow of liquid growth medium into second enclosure 138 by reducing the impedance to the downward flow of liquid growth medium caused by glass shards, platform 148, and gas within second enclosure 138 that would otherwise be displaced to allow the liquid growth medium to enter. Cavities 178 and 188 can reduce the likelihood that gas may be entrapped within second enclosure 138, for example, by the amount of liquid growth medium accumulating among the glass shards, thereby preventing gas displacement within second enclosure 138 and correspondingly preventing the maximum amount of liquid growth medium from entering second enclosure 138. This mechanism, referred to herein as a "liquid lock," can result in maintaining the amount of liquid growth medium in the first enclosure away from carrier 140, which can prevent the successful cultivation of any microorganisms on carrier 140 that may have survived the sterilization cycle, thereby increasing the likelihood of an erroneous determination of cycle effectiveness.

[0061] The likelihood of liquid lock formation is further reduced or prevented by allowing the liquid growth medium to impinge on the interior sidewall 116 above the support 130 largely unobstructed, as the surface area of ​​the interior sidewall 116 that the liquid can initially wet is maximized, allowing a greater amount of liquid to flow down along the interior sidewall 116 instead of onto the collection of glass shards that collects on the insert 146. By reducing the amount of liquid flowing onto and through the collection of shards, the likelihood that liquid can pool between the shards and form a liquid lock is minimized.

[0062] After ampoule 142 breaks as described above, the glass shards that were once ampoule 142 collect on platform 148 of insert 146 and remain in first enclosure 136, while the liquid growth medium collects in second enclosure 138. At this point, the user incubates SCBI 100 using an incubator, as is well known in the art, to promote the growth of any surviving microorganisms. After incubation, the liquid growth medium in second enclosure 138 can be assayed to determine whether the microorganisms were able to survive the sterilization cycle. Because second enclosure 138 does not contain glass shards within the liquid growth medium, the glass shards do not impair the accuracy of any indication made visually or by a color or fluorescent sensor. Therefore, the reliability of the determination of the effectiveness of the sterilization cycle is improved over a similar determination based on assaying a mixture of liquid growth medium and glass shards.

[0063] II. Structure that promotes ampoule breakage A user applies force to cap 104 to activate SCBI 100 and break glass ampoule 142. By providing a structure within SCBI 100 that concentrates the user's applied force over a narrow area of ​​glass ampoule 142, as compared to distributing the resistive force over a wider area of ​​glass ampoule 142, the amount of force the user must apply to cap 104 can be minimized. Referring to FIGS. 1-4 , insert 146 includes stress concentration portions 170, 180, and 190. Glass ampoule 142 rests on these stress concentration portions. Specifically, second end 144 of glass ampoule 142 contacts first stress concentration portion 170, second stress concentration portion 180, and third stress concentration portion 190. Thus, a force applied to cap 104 concentrates a reaction pressure at these three points. Because pressure equals force divided by surface area (P=F / A), for a given force, pressure is inversely proportional to surface area. Therefore, reaction pressure is maximized by minimizing the surface area that opposes the force that cap 104 applies to ampoule 142. The three points thus maximize reaction pressure on the glass ampoule. While theoretically one or two points could result in greater reaction pressure, in some embodiments, three contact points may be used to maintain the position of ampoule 142 as described above.

[0064] As mentioned above, stress concentrating portions 170, 180, and 190 need not be identical. For example, they can each have a triangular shape, but the angle between their respective base portions (171, 181, 191) and hypotenuse portions (173, 183, 193) can be somewhat different. If the angles are different, the resistive forces exerted by stress concentrating portions 170, 180, and 190 on ampoule 142 are applied asymmetrically. It is believed that this asymmetric application of force causes an increase in the stress generated in ampoule 142, thereby reducing the amount of force a user must apply to cap 104 to break ampoule 142.

[0065] In those embodiments in which the inner surface 106 of the cap 104 contacts the ampoule 142 asymmetrically, further asymmetry between the forces can be achieved. For example, as shown in FIG. 3 , the curved portion 156 contacts the first end 143 on the left side 105 of the first end 143, rather than on the right side 107 of the first end 143. Thus, a downward force applied to the cap 104 by the user results in the cap 104 imparting a force on the ampoule 142 that includes a lateral component.

[0066] In embodiments utilizing stress concentration portions 170, 180, and 190, ampoule 142 may break after application of an applied force to cap 104 that generates at least four resistance forces at separate locations on ampoule 142. These resistance forces occur at least at (1) inner surface 106 of cap 104, which in some embodiments includes curved portion 156, where ampoule 142 contacts, (2) stress concentration portion 170, (3) stress concentration portion 180, and (4) stress concentration portion 190.

[0067] 7-8, another embodiment of the present technology is shown. SCBI 200 includes an insert member 246, a housing 202, and a cap 204. Insert member 246 includes a tubular wall 264. Originating from tubular wall 264 is an arm (or finger) 251. Arm 251 has a top portion 253 and a bottom portion 255. Bottom portion 255 is disposed on and connected to tubular wall 264. Arm 251 is made of a semi-rigid material, such as plastic, and has a thickness such that arm 251 can bend when subjected to compression and / or lateral forces. For example, when a lateral force is applied to top portion 253, arm 251 can bend laterally near bottom portion 255 where arm 251 joins tubular wall 264. Arm 251 may be hollow or may have one or more channels or openings disposed therein to reduce the amount of force required to deflect arm 251. The channels or openings can also help prevent arms 251 from blocking liquid growth medium from impacting interior sidewall 216 when ampoule 242 is broken, which is important in minimizing the possibility of liquid lock, as described above with respect to SCBI 100. Insert member 246 can be assembled as an assembly of multiple elements, or can be manufactured as a single element, for example, by injection molding.

[0068] Cap 204 includes protrusion 212 that may be flat, beveled, arcuate, circular, conical, or some combination thereof. As shown in FIG. 7, arm 251 is configured such that apex 253 of arm 251 is positioned proximate protrusion 212. In some embodiments, apex 253 can contact protrusion 212. In other embodiments, there may be a lateral and / or vertical gap between apex 253 and protrusion 212 of about 0.1 mm to 5 mm.

[0069] SCBI 200 functions similarly to SCBI 100, except that the force that can be applied to cap 204 of SCBI 200 to break glass ampoule 242 is less than the force that can be applied to cap 104 of SCBI 100 to break glass ampoule 142 because of arm 251. In use, when a user applies force to cap 204, arm 251 impedes movement of cap 204 because arm 251 is an obstacle in the path of protrusion 212. However, arm 251 is not a complete obstacle because it can bend from a first orientation to a second orientation toward interior sidewall 216 near its connection with tubular wall 264. In some configurations, bending of arm 251 is limited by interior sidewall 216. As cap 204 is compressed by the application of an applied force, the lateral force generated by arm 251 impeding the movement of protrusion 212 acts on protrusion 212, causing protrusion 212 to bend or pivot from the third orientation to the fourth orientation. Protrusion 212 therefore exerts a lateral reaction force on glass ampoule 242. In doing so, glass ampoule 242 impedes the movement of cap 204 and protrusion 212, and any reaction force generated where ampoule 242 contacts other elements of the SCBI acts asymmetrically on ampoule 242 until the stress within ampoule 242 becomes large enough to fracture it. Similar to insert member 146, insert member 246 can include multiple stress concentrators. For example, first stress concentrator 270 is visible in FIG. 8 . In some embodiments of insert member 246, three stress concentrators may be used, similar to insert member 146. It is believed that this asymmetric application of force causes an increase in the stress generated in ampoule 242 , thereby reducing the amount of force a user must apply to cap 204 to break ampoule 242 .

[0070] In embodiments utilizing first stress concentration portion 270, second stress concentration portion, third stress concentration portion, and arm 251, ampoule 242 may break after application of an applied force to cap 204 that generates at least five resistive forces at distinct locations on ampoule 242. These reaction forces occur at least where: (1) top 243 of ampoule 242 contacts cap 204, (2) ampoule 242 contacts first stress concentration portion 270, (3) ampoule 242 contacts the second stress concentration portion, (4) ampoule 242 contacts the third stress concentration portion, and (5) arm 251 distorts stress concentration portion 212 into ampoule 242.

[0071] The relative positions of arm 251 and protrusion 212 can be reversed so that protrusion 212 is closer to interior sidewall 216 than arm 251, and arm 251 contacts ampoule 242 to help maintain its position within housing 202. In this configuration, when cap 204 is compressed, protrusion 212 applies a lateral force to arm 251, which in turn applies a lateral force to glass ampoule 242.

[0072] It should be understood that any of the examples and / or embodiments described herein may have various other features in addition to or instead of those described above. The teachings, representations, embodiments, examples, etc. described herein should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein.

[0073] While exemplary embodiments of the subject matter encompassed by the present invention have been shown and described, further applications of the methods and systems described herein may be achieved by appropriate modifications without departing from the scope of the claims. Such modifications will be apparent to those skilled in the art. For example, the above-described examples, embodiments, geometries, materials, dimensions, proportions, steps, etc., are exemplary. Therefore, the claims should not be limited to the details of structure and operation set forth in the specification and drawings.

[0074] [Embodiment] (1) A biological sterilization indicator comprising: (a) a housing having a first enclosure and a second enclosure; (b) an ampoule containing a liquid growth medium, at least a portion of the ampoule being disposed within the first enclosure; and (c) an insert member at least partially disposed in the first enclosure, the insert member comprising: (i) a platform including a top surface, abutment surface, and sides; (ii) a first cavity disposed in the platform and configured to allow a first amount of the liquid growth medium to pass into the second enclosure; (iii) an insert member including a second cavity disposed through at least a portion of the side and configured to allow a second amount of the liquid growth medium to pass into the second enclosure; 1. A biological sterilization indicator, comprising: (2) A biological sterilization indicator as described in embodiment 1, wherein the second cavity of the insert member is an angled cut through the abutment surface and the side surface. (3) A biological sterilization indicator as described in embodiment 2, wherein the angled notch of the insert member is located entirely below the upper surface. (4) A biological sterilization indicator as described in embodiment 3, wherein the insert member further includes a wall disposed on the upper surface of the platform. (5) A biological sterilization indicator as described in embodiment 4, wherein the wall has a cylindrical shape.

[0075] (6) A method of using a biological sterilization indicator, comprising: (a) providing the biological sterilization indicator, the biological sterilization indicator comprising: (i) an ampoule containing a liquid growth medium; (ii) an insert member at least partially disposed within the first enclosure of the biological sterilization indicator, the insert member comprising: a platform including a top surface, an abutment surface, and a side surface; a first cavity disposed through the platform and configured to allow a first amount of the liquid growth medium to pass into the second enclosure; an insert member having a second cavity disposed through at least a portion of the side and configured to allow a second amount of the liquid growth medium to pass into the second enclosure; (b) destroying the ampoule; (c) allowing the first amount of the liquid growth medium to pass through the first cavity; (d) allowing the second amount of the liquid growth medium to pass through the second cavity; A method comprising: (7) The method of embodiment 6, further comprising preventing the formation of a liquid lock. (8) A biological sterilization indicator comprising: (a) a housing having an interior side wall, an interior bottom wall, a first enclosure, a second enclosure, and a support for the interior side wall, the first enclosure being disposed above the support and the second enclosure being disposed between the interior bottom wall and the support; (b) an ampoule, at least a portion of which is disposed within the first enclosure, the ampoule having a first end and a second end; (c) a cap having an inner surface and an outer surface, the cap being disposed over a portion of the housing that includes at least a portion of the first enclosure; (d) a carrier disposed on the inner bottom wall; (e) an insert member, (i) a platform including an upper surface and an abutment surface, the second end of the ampoule being disposed on the upper surface and the abutment surface being disposed on the support; (ii) an insert member including legs extending toward the interior bottom wall, the legs having a length less than the distance between the support and the interior bottom wall such that there is a gap between the support and the legs; 1. A biological sterilization indicator, comprising: (9) The biological sterilization indicator of embodiment 8, wherein the length of the leg is about 0.1 to 2 millimeters shorter than the distance between the support and the inner bottom wall. (10) The biological sterilization indicator of embodiment 9, wherein the upper surface of the platform includes at least three stress concentration portions, and the second end of the ampoule contacts each of the at least three stress concentration portions.

[0076] (11) The biological sterilization indicator of embodiment 10, wherein the cap further includes an annular protrusion originating on the inner surface and extending toward the second enclosure of the housing, and the first end of the ampoule is disposed within the annular protrusion. (12) The biological sterilization indicator of embodiment 11, wherein the first end of the ampoule is connected to the annular projection by a friction fit. (13) The biological sterilization indicator of embodiment 11, wherein the ampoule has an annular cross-section with an outer diameter that is about 0.1 to 1 millimeter shorter than the inner diameter of the annular projection. (14) The biological sterilization indicator of embodiment 11, wherein the inner surface of the cap contacts the first end of the ampoule. (15) A biological sterilization indicator comprising: (a) a housing having a first enclosure, a second enclosure, and a first wall including a support disposed between the first enclosure and the second enclosure; (b) an ampoule, at least a portion of which is disposed within the first enclosure, the ampoule having a first end and a second end; (c) a cap having an inner surface and an outer surface, the cap being disposed over a portion of the housing that includes at least a portion of the first enclosure; (d) an insert member, (i) a platform disposed on the support; (ii) an insert member having a first stress concentrating portion, a second stress concentrating portion, and a third stress concentrating portion, each disposed on the platform and each contacting the second end of the ampoule; 1. A biological sterilization indicator, comprising:

[0077] (16) The biological sterilization indicator of embodiment 15, wherein the insert member further includes a second wall originating on the platform and extending away from the second enclosure. (17) The biological sterilization indicator of embodiment 16, wherein the first stress concentrating portion, the second stress concentrating portion, and the third stress concentrating portion each have a triangular shape including a base portion, a height portion, and a hypotenuse portion, each base portion contacting the platform, each height portion contacting the second wall, and each hypotenuse portion contacting the second end of the ampoule. (18) The biological sterilization indicator of embodiment 17, wherein an angle between the platform and the hypotenuse portion of the first stress concentrator is different from an angle between the platform and the hypotenuse portion of the second stress concentrator. (19) The biological sterilization indicator of embodiment 18, wherein an angle between the platform and the hypotenuse portion of the first stress concentration portion is different from an angle between the platform and the hypotenuse portion of the third stress concentration portion, and an angle between the platform and the hypotenuse portion of the second stress concentration portion is different from an angle between the platform and the hypotenuse portion of the third stress concentration portion. (20) The biological sterilization indicator of embodiment 19, wherein the angle between the platform and the hypotenuse portion of the second stress concentrator is within about 5 degrees of the angle between the platform and the hypotenuse portion of the third stress concentrator.

[0078] (21) The biological sterilization indicator of embodiment 20, wherein the angle between the platform and the hypotenuse portion of the second stress concentrator is equal to the angle between the platform and the hypotenuse portion of the third stress concentrator. (22) The cap is movable from a first position to a second position, and the biological sterilization indicator is (a) a protrusion originating at the inner surface of the cap and extending toward the insert; (b) an arm originating at the second wall and extending toward the cap, the arm adapted to prevent movement of the cap by interference with the protrusion, the arm further adapted to move from a first orientation to a second orientation to allow movement of the cap to the second position; 20. The biological sterilization indicator of embodiment 17, further comprising: (23) The biological sterilization indicator of embodiment 22, wherein the arm includes an opening therethrough and the protrusion is adapted to move from a third orientation to a fourth orientation. (24) The biological sterilization indicator of embodiment 23, wherein the arm is positioned relative to the protrusion such that the ampoule is positioned to prevent bending of the protrusion from the third orientation to the fourth orientation. (25) The biological sterilization indicator of embodiment 23, wherein the arm is positioned relative to the protrusion such that the ampoule is positioned to prevent bending of the arm from the first orientation to the second orientation.

[0079] (26) A method for activating a biological sterilization indicator, comprising: (a) providing the biological sterilization indicator, the biological sterilization indicator including a housing, a cap, an ampoule, and an insert; the cap includes an inner surface and a protrusion originating at the inner surface and extending toward the insert member; the insert member includes at least three stress concentrating portions and an arm extending toward the cap; a first end of the ampoule disposed within the cap and a second end of the ampoule resting on the at least three stress concentrators; (b) exerting an applied force on the biological sterilization indicator; (c) generating at least five reaction forces at distinct locations on the ampoule; and A method comprising:

Claims

1. 1. A method of using a biological sterilization indicator, comprising: (a) providing the biological sterilization indicator, the biological sterilization indicator comprising: (i) an ampoule containing a liquid growth medium; (ii) an insert member at least partially disposed within the first enclosure of the biological sterilization indicator, the insert member comprising: a platform including a top surface, an abutment surface, and a side surface; a first cavity disposed through the platform and configured to allow a first amount of the liquid growth medium to pass into a second enclosure; an insert member having a second cavity that is an angled cut through at least a portion of the side surface and configured to allow a second amount of the liquid growth medium to pass into the second enclosure; (b) destroying the ampoule; (c) allowing the first amount of the liquid growth medium to pass through the first cavity; (d) allowing the second amount of the liquid growth medium to pass through the second cavity; (e) incubating the biological sterilization indicator to promote microbial growth; (f) assaying the liquid growth medium in the second enclosure after incubation to determine whether microorganisms were able to survive a sterilization cycle; A method comprising:

2. The method of claim 1 further comprising preventing the formation of a liquid lock.

3. The method of claim 1 , wherein the angled cut is located entirely below the upper surface.

4. The method of claim 3 , wherein the insert member further comprises a wall disposed on the upper surface of the platform.

5. The method of claim 4 , wherein the wall has a cylindrical shape.

6. The method of claim 1 , wherein at least a portion of the ampoule is disposed within the first enclosure.

7. The method of claim 1 , wherein the insert member comprises a leg.

8. 8. The method of claim 7, wherein the biological sterilization indicator comprises a cap having an inner surface and an outer surface, the cap being disposed over a portion of the first enclosure.

9. 1. A method of using a biological sterilization indicator, comprising: (a) breaking the ampoule to release the liquid growth medium; (b) allowing a first amount of the liquid growth medium to pass through a first cavity formed in an insert; (c) allowing a second amount of the liquid growth medium to pass through a second cavity, the second cavity being an angled cut through a portion of a side of the insert; (d) incubating the biological sterilization indicator to promote microbial growth; (e) assaying the liquid growth medium after incubation to determine whether the microorganisms were able to survive the sterilization cycle; A method comprising:

10. The method of claim 9 , wherein the insert member is disposed at least partially within the first enclosure.

11. The method of claim 10 , wherein the insert member includes a platform including an upper surface, an abutment surface, and the side surface.

12. The method of claim 9 further comprising preventing the formation of a liquid lock.

13. The method of claim 11 , wherein the angled cut is located entirely below the upper surface.

14. The method of claim 13 , wherein the insert member further comprises a wall disposed on the upper surface of the platform.

15. The method of claim 14 , wherein the wall has a cylindrical shape.

16. The method of claim 9 , wherein at least a portion of the ampoule is disposed within a first enclosure.

17. The method of claim 11 , wherein the insert member includes a leg.

18. 10. The method of claim 9, wherein the biological sterilization indicator comprises a cap having an inner surface and an outer surface, the cap being disposed over a portion of the first enclosure.

19. 1. A method of using a biological sterilization indicator, comprising: (a) breaking an ampoule at least partially disposed within a first enclosure to release a liquid growth medium; (b) permitting a first amount of the liquid growth medium to pass through a first cavity formed in an insert member at least partially disposed within the first enclosure; (c) allowing a second amount of the liquid growth medium to pass through a second cavity, the second cavity being an angled cut through a portion of a side of the insert; (d) incubating the biological sterilization indicator to promote microbial growth; (e) assaying the liquid growth medium after incubation to determine whether the microorganisms were able to survive the sterilization cycle; wherein allowing passage through the first cavity and allowing passage through the second cavity prevents formation of a liquid lock.

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