Built-in biological indicator

Abstract

To provide a biological sterilization indicator. [Solution] The invention comprises a housing having a first enclosure and a second enclosure; an ampoule containing a liquid growth medium, wherein at least a portion of the ampoule is positioned inside the first enclosure; a cap having a projection configured to be movable relative to the housing; and an insertion member at least partially positioned inside both the first enclosure and the second enclosure, having a platform and an arm, which engages with the projection and is configured to generate a lateral force on the ampoule in response to the application of force to the cap, thereby breaking the ampoule and releasing the liquid growth medium.

Description

Technical Field

[0001] The content disclosed in this specification relates to an embedded biological sterilization indicator.

Background Art

[0002] Medical devices are usually sterilized before use to minimize the possibility that a contaminated device that may cause an infectious disease to the subject is used on the subject. Various sterilization techniques may be used, such as steam, hydrogen peroxide, and gas-phase sterilization, with or without the use of 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 to be sterilized.

[0003] Before sterilization, medical devices are usually packaged in a container or pouch with a semi-permeable barrier, which allows the permeation of a sterilizing fluid, sometimes called a sterilant, but prevents the entry of contaminating microorganisms, especially until the package is opened by a healthcare worker after sterilization. In an effective sterilization cycle, contaminating microorganisms within the package must be killed because any microorganisms that survive the sterilization cycle can grow and recontaminate the medical device.

[0004] The packaging helps prevent contamination of the sterile medical device, but it can increase the difficulty of achieving a successful sterilization cycle because the packaging hinders the sterilant from reaching the device or instrument contained therein. This is particularly a problem for devices and instruments with diffusion-limited spaces inside them, because these diffusion-limited spaces reduce the possibility that the sterilization cycle can be effective. For example, an endoscope usually has an elongated lumen where the sterilant must diffuse at a sufficient concentration for a sufficient time to achieve a successful sterilization cycle.

[0005] Confirming that a sterilization cycle has been effective helps healthcare professionals avoid using contaminated medical devices on patients. Normally, sterilized medical devices themselves do not check for contaminating microorganisms, as such action can introduce other contaminating microorganisms to the device, thereby re-contaminating it. 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 in close proximity to a medical device that is subjected to a sterilization cycle, and as a result, the sterilization indicator undergoes the same sterilization cycle as the medical device. For example, a biological indicator containing a predetermined amount of microorganisms with known resistance to sterilizing agents may be placed in the sterilization chamber together 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 whether any of the microorganisms survived the cycle.

[0007] Certain biological indicators are referred to as “in-situ” (SCBIs). These biological indicators typically include a housing containing a growth medium source in a fragile container, along with a quantity of microorganisms, placed near the microorganisms. Like other biological indicators, “in-situ” biological indicators (“SCBIs”) may undergo a sterilization cycle along with the medical device. After the cycle, the fragile container can be destroyed to release the growth medium and allow the viable microorganisms to be cultured in situ. SCBIs can be cultured at high temperatures, typically around 50°C to 60°C, which promotes the growth of viable microorganisms. Culturing using commercially available products typically lasts for about 24 hours. During this time, it is desirable for healthcare personnel not to use the medical device, while the sterilization effect remains unconfirmed. This can lead to inefficiencies in inventory management for healthcare providers, such as hospitals. This could, for example, require the medical device to be stored while unusable, and healthcare providers would likely need to stock more medical devices to ensure a sufficient supply of medical equipment. Alternatively, healthcare providers could use the medical device before the culture is complete and the sterilization effect has been confirmed. However, using medical devices before their sterilization effectiveness is confirmed could expose those being treated to the risk of infection from the medical devices themselves.

[0008] After culturing, 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 growth media that change color in the presence of microorganisms. This color change may be due to pH fluctuations caused by acid production by living microorganisms that metabolize the growth media, and they also contain pH-indicating dyes. Other SCBIs are designed to contain growth media that contain a fluorescent substance whose fluorescence depends on the amount of viable microorganisms present in the medium. In these SCBIs, a change in color or fluorescence level indicates that viable microorganisms can be grown during culturing.

[0009] Fragile containers for SCBIs containing liquid growth media are often made from glass. The glass must be sufficiently robust to prevent breakage during transport, for example, from the SCBI manufacturer to the healthcare provider. However, such robustness often translates to greater force required for healthcare personnel to break the ampoule in the desired time. Therefore, some SCBI manufacturers provide hospital staff with actuators to assist them in breaking the ampoules.

[0010] The microorganisms in SCBI are often placed on a carrier. These carriers can be manufactured from various materials, such as paper or fiberglass. If elements within the SCBI, such as fragile containers, are not restricted from contact with the carrier, the carrier can be damaged, especially during transport. For example, during transport, fragile containers may bump against each other within the SCBI, causing repeated and forceful impacts on the carrier, potentially damaging it. Such damage can increase the likelihood that the carrier may be dislodged from its position, where it must be positioned for the normal functioning of the SCBI.

[0011] Changes in the color or turbidity of SCBI liquid growth medium can be visually determined by individual healthcare workers without the aid of automated equipment. Alternatively, changes in color, turbidity, or fluorescence can be determined with the help of color and / or fluorescence sensors incorporating automated equipment. The accuracy of such determinations may be reduced by the presence of fragments from the fragile container that originally contained the growth medium, as these fragments may block or partially interrupt the optical path between the SCBI and the sensor, or they may alter the wavelength of light or the amount of fluorescence from the SCBI that the sensor can detect. Furthermore, the fragments may prevent the entire required amount of growth medium from coming into contact with the carrier, as the fragments can come into contact with the carrier and thereby provide an obstacle between the growth medium and the carrier. The fragments may also create small amounts of air, gas, and vapor in between, which may be necessary for a sufficient amount of growth medium to move to reach the carrier. [Overview of the Initiative] [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 liquid growth medium, and an insert member at least partially located in the first enclosure. In some embodiments, a portion of the ampoule is located inside the first enclosure, and no ampoule is located inside the second enclosure. In some embodiments, the insert member includes a platform including a top surface, a contact surface, and sides. In some embodiments, the insert member has a first cavity located 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 located through at least a portion of the side 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 contact surface and the side. In some embodiments, the angled notch may be located below the top surface overall. In some embodiments, the insert member further includes a wall located 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 carry out a method comprising the steps of: providing a biological sterilization indicator; breaking an ampoule; allowing a first amount of liquid growth medium to pass through a first cavity; and allowing a second amount of liquid growth medium to pass through a second cavity. The method further includes the step of preventing the formation of a liquid lock.

[0014] In some other embodiments, a biological sterilization indicator is disclosed, comprising a housing, an ampoule, a cap, a carrier, and an insert member. In some of these embodiments, the housing has an internal side wall, an internal bottom wall, a first enclosure, a second enclosure, and a support for the internal side wall, the first enclosure being positioned above the support, and the second enclosure being positioned between the internal 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 positioned inside the first enclosure. In some of these embodiments, the cap has an internal surface and an external surface, and the cap is positioned on a portion of the housing, including at least a portion of the first enclosure. In some of these embodiments, the carrier is positioned on the internal bottom wall. In some of these embodiments, the insert member has a platform, which includes a top surface and a contact surface. In some of these embodiments, the second end of the ampoule is positioned on the top surface, and the contact surface is positioned on the support. In some of these embodiments, the insert member has legs extending toward the internal bottom wall. In some of these embodiments, the legs have a length shorter than the distance between the support and the inner bottom wall, resulting in a gap between the support and the legs. In some of these embodiments, the length of the legs is about 0.1 to 2 millimeters shorter than the distance between the support and the inner bottom wall. In some of these embodiments, the upper surface of the platform includes at least three stress concentration areas, and the second end of the ampoule is in contact with at least each of the three stress concentration areas. In some of these embodiments, the ampoule is positioned within an annular projection that begins on the inner surface of the cap and extends toward a second enclosure of the housing. In some of these embodiments, the first end of the ampoule is connected to the annular projection by friction fitting. In some of these embodiments, the ampoule has an annular cross-section with an outer diameter about 0.1 to 1 millimeter shorter than the inner diameter of the annular projection. In some of these embodiments, the inner surface of the cap is in contact with the first end of the ampoule.

[0015] Further embodiments disclose a biological sterilization indicator comprising a housing, an ampoule, a cap, and an insert member. In some of these embodiments, the housing has a first wall containing a first enclosure, a second enclosure, and a support positioned 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 positioned inside the first enclosure. In some of these embodiments, the cap is positioned 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 member having a platform, which is positioned on the support. In some of these embodiments, the insert member has a first stress concentration portion, a second stress concentration portion, and a third stress concentration portion. In some of these embodiments, each stress concentration portion is positioned on the platform and each is in contact with the second end of the ampoule. In some of these embodiments, the insert member further includes a second wall starting from the platform and extending away from the second enclosure.

[0016] In further embodiments of other embodiments, the biological sterilization indicator includes at least a first stress concentration portion, a second stress concentration portion, and a third stress concentration portion, each stress concentration portion having a triangular shape including a base portion, a height portion, and a hypotenuse portion. In some of these embodiments, each bottom portion is in contact with the platform, each height portion is in contact with the second wall, and each hypotenuse portion is in contact with the second end of the ampoule. In some of these embodiments, the angle between the platform and the hypotenuse portion of the first stress concentration portion is different from the angle between the platform and the hypotenuse portion of the second stress concentration portion. In some of these embodiments, the angle between the platform and the hypotenuse portion of the first stress concentration portion is different from the angle between the platform and the hypotenuse portion of the third stress concentration portion, and the angle between the platform and the hypotenuse portion of the second stress concentration portion is different from the angle between the platform and the hypotenuse portion of the third stress concentration portion. In some of these embodiments, the angle between the platform and the hypotenuse portion of the second stress concentration portion is within about 5 degrees of the angle between the platform and the hypotenuse portion of the third stress concentration portion. In some of these embodiments, the angle between the platform and the hypotenuse of the second stress concentration is equal to the angle between the platform and the hypotenuse of the third stress concentration.

[0017] In further embodiments of other embodiments, the insert member further includes a second wall that begins on the platform and extends away from the second enclosure, and the cap is movable from a first position to a second position. In some of these embodiments, the cap includes a projection that begins on the inner surface of the cap and extends toward the insert member. In some of these embodiments, the cap includes an arm that begins on the second wall and extends toward the cap, and the arm is adapted to prevent movement of the cap by interfering with the projection. In some of these embodiments, the arm is adapted to move from a first orientation to a second orientation in order to allow movement of the cap to a second position. In some of these embodiments, the arm includes an opening through the arm. In some of these embodiments, the projection is adapted to move from a third orientation to a fourth orientation. In some of these embodiments, the arm is positioned relative to the projection such that the ampoule is positioned to prevent bending of the projection from the third orientation to the fourth orientation. In some of these embodiments, the arm is positioned relative to the projection such that the ampoule is positioned to prevent the arm from bending 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 preceding two paragraphs, can be used to perform a method that includes the steps of applying a force to the biological sterilization indicator and generating at least five reaction forces at separate locations on the ampoule.

[0019] As used herein, the term “surface” should be understood as a feature that forms the boundary of an object.

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

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

[0022] As used herein, the term "enclosure" shall be understood as the space or cavity inside an object that is at least partially defined by the surface of the object or the surface of another object contained therein.

[0023] As used herein, the term "insertion member" shall be understood as an object disposed within one or more enclosures of an object.

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

[0025] As used herein, the term "liquid lock" shall be understood as an obstruction to the path of an amount of flowing liquid, and the obstruction is formed at least in part by an amount of static gas and / or liquid.

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

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

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

[0029] As used herein, the term "leg" shall be understood as an elongated member that begins with and extends away from other features of the object.

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

[0031] As used herein, the term "applied force" shall be understood as a force applied directly or indirectly from a user to an object, regardless of the presence or absence of the assistance of other objects or devices.

[0032] As used herein, the term "reaction force" shall be understood as a force generated by an object that receives an applied force corresponding to the applied force, where at least an element of the reaction force indicates a direction opposite to the direction of the applied force.

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

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

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

[0036] As used herein, the term "friction fit" shall be understood as a connection relationship between two or more surfaces achieved by friction.

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

[0038] As used herein, the term “obstruct” should be understood as causing at least a partial or temporary obstruction of movement.

[0039] As used herein, the term “bending” should be understood as a bending action occurring in a bendable object or feature as a result of the application of a deflection force to that object or feature.

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

[0041] The biological sterilization indicator disclosed herein is robust enough to allow transport to continue without causing ampoule breakage or carrier decomposition, while reducing the amount of force required to break the ampoule by pressing the cap. The biological sterilization indicator disclosed herein helps prevent artifacts, such as fragments 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 growth medium's color or fluorescence. The biological sterilization indicator disclosed herein helps prevent the formation of interfering particles in such artifacts that could prevent a desired amount of growth medium from coming into contact with the carrier. [Brief explanation of the drawing]

[0042] This specification concludes with claims that identify and clearly assert the subject matter described herein, but a deeper understanding of the subject matter can be obtained by reading the descriptions of the specific examples below in conjunction with the accompanying drawings. In the drawings, similar reference numerals indicate the same element. [Figure 1]A side view of the first example embodiment of SCBI is shown. [Figure 2] Figure 1 shows an isometric decomposition view of the first SCBI example. [Figure 3] Figures 1 and 2 show cross-sectional views of the first SCBI example, cut along line AA in Figure 1. [Figure 4] Figures 1 to 3 show isometric views of the insertion member of the first example of SCBI, as shown in the first example. [Figure 5] Figure 4 shows a plan view of a first example embodiment of the insertion member. [Figure 6] Figure 5 shows a cross-sectional view of the insertion member shown in Figures 4 and 5, cut along line BB in Figure 5, representing an embodiment of the first example. [Figure 7] An isometric view of a second example embodiment of SCBI is shown. [Figure 8] Figure 7 shows an isometric view of the insertion member of the second example of SCBI, as shown in the second example. [Modes for carrying out the invention]

[0043] The following description provides specific illustrative examples of the claimed subject matter. Other examples, features, aspects, embodiments and advantages of the Art will be apparent to those skilled in the art from the following description. Therefore, the drawings and description should be considered substantially illustrative.

[0044] I. Integral Biological Indicators Referring to Figures 1 to 3, an internal 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 projections 112 having planar, slanted, arched, annular, conical, or several combinations thereof. The cap 104 may further include one or more through holes 110 to facilitate the passage of gas (e.g., air or a sterilizer) into or out of the SCBI. A chemical indicator 196, which may be a sticker that changes color when exposed to a sterilizer, may be attached 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 the compression of the side wall 114. The top 134 of the housing 102 is opposite the bottom wall 120, thereby defining an opening 132. The housing 102 can be further defined by the top 124 and the bottom 128 having a support 130 positioned between the top and bottom, further defining a first enclosure 136 and a second enclosure 138 within the housing 102. As is well known in the art of SCBI, the cap 104 is positioned relative to the housing 102 in a first position and is configured to move from the first position to a second position. In the first position (shown in Figures 1 and 3), the cap 104 is connected to the housing 102 so that a gas (e.g., air or a sterilizing agent) can move from the surrounding environment into the SCBI, and vice versa. In this position, any through-hole 110 of the cap 104 is positioned above the apex 134, and as a result, the first enclosure 136 and the second enclosure 138 are in fluid communication with the surrounding environment, thereby allowing the introduction and cessation of sterilizing agents into the first enclosure 136 and the second enclosure 138 through the through-hole 110. The cap 104 can be pressed against the housing 102 to the second position.In this second position, the through-hole 110 is located below the top end 134, which has a tightly fitted cap 104 and an outer side wall 118, the outer side wall blocking the through-hole 110 and effectively sealing the first enclosure 136 and the second enclosure 138 from the surrounding environment.

[0045] SCBI 100 also includes a microorganism or source of 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. Therefore, the carrier 140 may be impregnated with spores from Bacillus, Geobacillus, and / or Clostridium species. The carrier 140 may be absorbent and may be formed from filter paper. Sheet materials such as cloth, nonwoven polypropylene, rayon or nylon, and microporous polymer materials may be used. Non-absorbent materials such as metal (e.g., aluminum or stainless steel), glass (e.g., glass beads or glass fibers), porcelain, or plastic are also suitable for use. Furthermore, the carrier 140 can be made from a combination of the materials described above. In some embodiments, the carrier 140 rests on an internal bottom wall 122. In some embodiments, the carrier 140 can have a thickness of about 0.1 to 0.5 millimeters.

[0046] SCBI 100 also includes a fragile glass ampoule 142 having a first end 143 and a second end 144. The ampoule 142 may contain a liquid growth medium. The growth medium must be capable of promoting the growth of any live microorganisms placed on the carrier 140 by culture. In some embodiments, the growth medium does not promote the growth of contaminating microorganisms that are not intentionally placed on the carrier 140, for example, because such contaminating microorganisms may cause color or fluorescence changes, which could lead to an inaccurate determination of the sterilization effect. The ampoule 142 may also contain a growth indicator, either in or separately from the growth medium. The growth indicator may be an enzyme or a dye such as a fluorescent dye, which helps to detect the growth of viable microorganisms. The growth indicator may also be an enzyme-substrate system, which may be a substrate or mixture of substrates on which an enzyme can act and convert into an enzyme-modified product or a plurality of such products. For example, the enzyme-substrate system may be a fluorescent substrate that emits fluorescence, unlike enzyme-modified products created by a reaction between an enzyme and a fluorescent substrate. In some embodiments, the fluorescent substrate emits little to no fluorescence, while the enzyme-modified product emits significantly more fluorescence than the substrate.

[0047] SCBI 100 may also include an insert member 146, which is described in detail in Figures 3 to 6. The insert member 146 may include a platform 148 having one or more sides, such as a top surface 150, a contact surface 152, a bottom surface 153, and a lower surface 154 and an upper surface 155. The insert member 146 may also include a tubular wall portion 164 on the platform 148, starting from the top surface 150 and / or the side 154 and extending away from the contact surface 152. The tubular wall portion 164 may have a hollow cylindrical shape. The diameter of this cylinder must be greater than the diameter of the ampoule 142 so that the second end 144 can be positioned within the tubular wall portion 164.

[0048] The first cavity (or path) 178 may be positioned through the platform 148. The first cavity 178 may have the shape of a hole, starting from the top surface 150 and ending at the bottom surface 153. The second cavity (or path) 188 may be positioned additionally or instead through the platform 148. The second cavity 188 may have the shape of an angled notch (e.g., a small groove or bevel), starting at least partially from the side surface 154 and ending at least partially at the contact surface 152. Although not shown, the cavity 188 may additionally traverse the top surface 150. The insert member 146 may include the cavity 178 and additional instances of the cavity 188. For example, in some embodiments, three instances of the cavity 188 are positioned through the platform 148, from the upper side surface 155 to the contact surface 152.

[0049] The insert member 146 may also include a leg (or a number of legs) 166 that starts from the bottom surface 153 and extends away from the platform 148. The leg 166 has a maximum length equal to the distance between the support 130 and the internal bottom wall 122 of the housing 102. As shown in Figure 3, the leg 166 has a length somewhat shorter than the distance between the support 130 and the internal bottom wall 122 of the housing 102. The leg 166 may have a length about 0.1 to 1 millimeter shorter than the distance between the support 130 and the internal 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 may also include a projection or stress concentration portion 170 positioned on the upper surface 150 of the platform 148. For example, the stress concentration portion 170 may have a rounded ridge, an angled ridge, or a wedge shape such as a triangular wedge. As shown in Figures 3 to 6, the stress concentration portion 170 has a triangular wedge shape. The triangular wedge may have the shape of a right triangle including a base portion 171, a height portion 172, and a hypotenuse portion 173. The base portion 171 may coincide with the upper surface 150, and the height portion 172 may coincide with the upper side surface 155 and / or the tubular wall portion 164. In such embodiments, the stress concentration portion 170 can function as a gusset that can reinforce the joint between the tubular wall portion 164 and the platform 148. The base portion 171 may be positioned at a first angle α with respect to the hypotenuse portion 173. The first angle α may be acute. The first angle can have values ​​between 45° and 85°.

[0051] The insert member 146 may further include a plurality of stress concentration points. For example, in addition to stress concentration point 170, it may also include stress concentration points 180 and 190. Like stress concentration point 170, stress concentration points 180 and 190 may have a rounded ridge, an angled ridge, or a wedge shape such as a triangular wedge, respectively. As shown in Figures 3 and 5, stress concentration point 180 has a triangular shape and includes a base portion 181, a height portion 182, and a hypotenuse portion 183. Stress concentration point 190 also has a triangular shape including a base portion 191, a height portion 192, and a hypotenuse portion 193. The base portion 181 may be positioned at a second angle β with respect to the hypotenuse portion 183, and the base portion 191 may be positioned at a third angle γ with respect to the 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 and third angles may be equal to each other and to the first angle. The second and third angles may be equal to each other but different from the first angle. The first, second, and third angles may each be different from each other. The insert member 146 can be assembled as an assembly of multiple elements, or it can be manufactured as a single element, for example by injection molding.

[0052] The insert member 146 is positioned within the SCBI 100. Specifically, the contact surface 152 of the platform 148 rests on—or touches—the support 130. Thus, the contact surface 152 and the support 130 together define the boundary between the first enclosure 136 and the second enclosure 138 of the housing 102. The legs or a plurality of legs 166 thus extend into the second enclosure 138 to help maintain the position of the carrier 140, which rests on the internal bottom wall 122 and must remain there throughout the life of the SCBI. However, since the legs or a plurality of legs 166 are shorter than the distance between the support 130 and the internal bottom wall 122, they do not contact the internal bottom wall 122. Preferably, the carrier 140 is thin enough so that a gap is also maintained between the legs or a plurality of legs 166 and the carrier 140. Such gaps should help prevent damage to the carrier 140 that may occur during transport of the SCBI from the manufacturer's manufacturing facility to, for example, a warehouse or healthcare facility. Such transport may be carried out, for example, by the manufacturer's agent or employee or by a carrier (e.g., the United States Postal Service, United Parcel Service). During transport, possibly including land transport, including by land transport vehicles such as trucks or trains, the SCBI may be subjected to repeated impacts, for example, caused by the impact of roads or train tracks. If the legs or multiple legs 166 may come into contact with the carrier 140, these impacts may damage the carrier 140. In such cases, the impacts may cause, for example, the legs or multiple legs 166 to repeatedly strike the carrier 140, thereby causing wear on the carrier 140 at any contact point. In the worst case, the wear may be sufficient to create holes in the carrier 140. Therefore, to help prevent such damage, there should be a gap of about 0.1 to 0.4 millimeters between the legs or multiple legs 166 and the carrier 140. Therefore, after the SCBI 100 is manufactured, it can be loaded onto a standard shipping vehicle such as a truck, and the vehicle can be transported to a destination such as a healthcare facility or warehouse to deliver the SCBI 100 to its destination.Destination workers may refrain from closely examining the SCBI 100 for damage to the carrier 140, based on the increased assurance that the carrier 140 is less likely to be damaged during transport. In an alternative embodiment, the leg 166 may include a retaining projection on it, such as a ring connected to the leg, the ring having a diameter equal to or approximately equal to the diameter or width of the carrier 140. The retaining projection may be positioned at a distance of up to 0.4 mm from the carrier 140, or it may be in contact with the carrier 140 at its outer edge.

[0053] The position of the glass ampoule 142 is maintained within the SCBI 100 by the insertion member 146 and cap 104 in its first position, so that the ampoule 142 does not come into contact with the housing 104. The curved portion 156 may help maintain the position of the ampoule 142. As shown in Figures 1 and 3, part of the ampoule 142 is located within the first enclosure 136, and part of the ampoule 142 is located within the cap 104, above the top end 134 of the housing 102. In the first enclosure 136, the second end 144 of the glass ampoule 142 rests on one or more of the platform 148 or stress concentration portions 170, 180, and 190, so that the second end 144 is located within the tubular wall portion 164 of the insertion member 146. The second end 144 of the glass ampoule 142 can contact the first stress concentration point 170, the second stress concentration point 180, and the third stress concentration point 190. The first end 143 of the ampoule 142 is located inside the cap 104. In some embodiments, the first end 143 of the ampoule 142 is in contact with the inner surface 106 of the cap 104, and in some embodiments, with the curved portion 156, so that the vertical movement of the glass ampoule 142 is suppressed by its contact with the cap 104 and the inserting member 146. In some embodiments, the first end 143 of the ampoule 142 may also be located inside the projection 112.

[0054] The projection 112 may be configured to form a secure fit with the ampoule 142. If the projection 112 is ring-shaped, it may have a diameter similar to or equal to the diameter of the ampoule 142. Thus, a friction fit may exist between the ampoule 142 and the projection 112. Alternatively, the diameter of the projection 112 may be slightly larger than the diameter of the ampoule 142 to provide a gap of about 0.1 mm to 3 mm between the ampoule 142 and the projection 112.

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

[0056] During use, the SCBI 100 undergoes a sterilization cycle, preferably together with medical devices that are sterilized by a sterilization cycle. After the sterilization cycle, the user operates the SCBI 100 by applying force to the cap 104 using the user's hand or other body part and / or with the assistance of a device suitable for the user to apply force to the cap 104. The cap 104, in some embodiments, the curved portion 156, applies at least a portion of the force the user applies to the cap 104 to the ampoule 142, which generates a reaction force between the cap 104 and the top portion 143. The ampoule 142, via the bottom portion 144, applies at least a portion of the force the user applies to the cap 104 to the stress concentration portions 170, 180, and 190 of the inserting member 146, which then generates a reaction force between the bottom portion 143 and the stress concentration portions 170, 180, and 190 of the inserting member 146. The inserting member 146, via the support 130, applies at least a portion of the force the user applies to the cap 104 to the contact surface 152, which generates a reaction force between the contact surface 152 and the support 130. When the force the user applies to the cap 104 generates a stress within the ampoule 142 that the ampoule 142 can withstand, the ampoule 142, made of glass, will shatter into glass fragments. The stress concentration points 170, 180, and 190 help increase the stress within the ampoule 142 with respect to a given force applied by the user directly to the cap 104 and indirectly to the ampoule 142, because the surface area of ​​the contact point between the bottom end 144 of the ampoule 142 and the stress concentration points 170, 180, and 190 is less than the surface area of ​​the cap 104 to which the user applies force to activate the SCBI, and / or less than the surface area of ​​the contact point between the cap 104, which may include a curved portion 156, and the top end 143 of the ampoule 142.

[0057] Once destroyed, the ampoule 142 ceases to exist to resist the force applied to the cap by the user. Thus, the force applied by the user moves the cap 104 to a second position where the cap effectively seals the SCBI 100. The inserting member 146 prevents glass fragments from entering the second enclosure 138, so that some glass fragments fall onto the platform 148 and the remaining glass fragments fall onto other glass fragments.

[0058] By rupturing ampoule 142, some more liquid growth medium is released, flowing downward through the fragments and through the cavity 178, and eventually collecting in the second enclosure 138. The remaining amount of liquid growth medium is ejected towards the inner side wall 116 of housing 102. Some of these amounts collide with the inner side wall 116, then flow downward, pass through the gap between the inner side wall 116 and the insert member 146, and eventually collect in the second enclosure 138.

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

[0060] Cavities 178 and 188 can further facilitate the flow of liquid growth medium into the second enclosure 138 by reducing the impedance to the downward flow of liquid growth medium caused by glass fragments, platform 148, and gas in the second enclosure 138, which would otherwise have been replaced to make way for the liquid growth medium. Cavities 178 and 188 can reduce the possibility that gas may be taken into the second enclosure 138 by, for example, the amount of liquid growth medium accumulating between the glass fragments, thereby preventing gas replacement in the second enclosure 138, and correspondingly preventing the maximum amount of liquid growth medium from entering the second enclosure 138. This mechanism, referred to herein as "liquid lock," can result in maintaining the amount of liquid growth medium in the first enclosure away from the carrier 140, which can prevent the successful cultivation of any microorganisms on the carrier 140 that may survive the sterilization cycle, thereby increasing the possibility of an incorrect determination of the effectiveness of the cycle.

[0061] The possibility of liquid lock formation is further reduced or prevented by allowing the liquid growth medium to collide with the internal sidewall 116 above the non-obstructive support 130, because the surface area of ​​the internal sidewall 116 that the liquid can first wet is maximized, thereby allowing a larger volume of liquid to flow down along the internal sidewall 116 instead of accumulating in the glass fragments on the insert member 146. By reducing the amount of liquid flowing over and through the fragment aggregate, the possibility of liquid accumulating between the fragments and forming liquid lock is minimized.

[0062] As described above, after ampoule 142 breaks, the glass fragments that were once part of ampoule 142 collect on the platform 148 of the insertion member 146 and remain in the first enclosure 136, while the liquid growth medium collects in the second enclosure 138. At this point, the user incubates the SCBI 100 using an incubator, as is well known in this technology, to promote the growth of the viable microorganisms. After culturing, the liquid growth medium in the second enclosure 138 can be assayed to determine whether the microorganisms were able to survive the sterilization cycle. Since the second enclosure 138 does not contain glass fragments in the liquid growth medium, the glass fragments do not impair the accuracy of any indication made visually or by color or fluorescence sensors. Therefore, the reliability of determining the effectiveness of the sterilization cycle is improved compared to similar determinations based on assays of a mixture of liquid growth medium and glass fragments.

[0063] II. Structures that promote ampoule breakage The user applies force to the cap 104 to activate the SCBI 100 and break the glass ampoule 142. By providing a structure within the SCBI 100 that concentrates the user's applied force on a narrow area of ​​the glass ampoule 142 compared to distributing the resistive force over a wider area of ​​the glass ampoule 142, the amount of force the user must apply to the cap 104 can be minimized. Referring to Figures 1 to 4, the insert member 146 includes stress concentration points 170, 180, and 190. The glass ampoule 142 rests on these stress concentration points. Specifically, the second end 144 of the glass ampoule 142 contacts the first stress concentration point 170, the second stress concentration point 180, and the third stress concentration point 190. Therefore, the force applied to the cap 104 concentrates the reaction pressure at these three points. Since pressure is equal to the force divided by the surface area (P=F / A), with respect to a given force, pressure is inversely proportional to the surface area. Therefore, the reaction pressure is maximized by minimizing the surface area that counteracts the force that cap 104 applies to ampoule 142. The three points thus maximize the reaction pressure against the glass ampoule. Theoretically, one or two points may result in a greater reaction pressure, but in some embodiments, three contacts may be used to maintain the position of ampoule 142 as described above.

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

[0065] In these embodiments, where the inner surface 106 of the cap 104 contacts the ampoule 142 asymmetrically, further asymmetry in the forces can be achieved. For example, as shown in Figure 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 to the ampoule 142 that includes a lateral component.

[0066] In embodiments utilizing stress concentration points 170, 180, and 190, the ampoule 142 may break after the application of a force to the cap 104 that generates at least four resistance forces at separate locations on the ampoule 142. These resistance forces are generated at least at (1) the inner surface 106 of the cap 104, including a curved portion 156 in some embodiments, (2) stress concentration point 170, (3) stress concentration point 180, and (4) stress concentration point 190, where the ampoule 142 makes contact.

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

[0068] The cap 204 includes projections 212 having planar, inclined, arched, annular, conical, or several combinations thereof. The arm 251 is constructed such that its apex 253 is positioned near the projections 212, as shown in Figure 7. In some embodiments, the apex 253 can contact the projections 212. In other embodiments, there may be a lateral and / or vertical gap of about 0.1 mm to 5 mm between the apex 253 and the projections 212.

[0069] The SCBI 200 functions similarly to the SCBI 100, but the force that can be applied to the cap 204 of the SCBI 200 to break the glass ampoule 242 is less than the force that can be applied to the cap 104 of the SCBI 100 to break the glass ampoule 142, due to the arm 251. When the user applies force to the cap 204 during use, the arm 251 obstructs the path of the projection 212, thus preventing the cap 204 from moving. However, the arm 251 is not a complete obstruction, as it can bend from a first direction to a second direction toward the internal side wall 216 near the connection with the tubular wall 264. In some structures, the bending of the arm 251 is limited by the internal side wall 216. As the cap 204 is pressed by the applied force, the lateral force generated by the arm 251, which is hindering the movement of the projection 212, acts on the projection 212, causing it to bend or pivot from a third to a fourth orientation. Thus, the projection 212 applies a lateral reaction force to the glass ampoule 242. In this process, the glass ampoule 242 hinders the movement of the cap 204 and the projection 212, and any reaction forces generated at the point where the ampoule 242 contacts other elements of the SCBI act asymmetrically on the ampoule 242 until the stress inside the ampoule 242 becomes large enough to break it. Similar to the insert member 146, the insert member 246 may include multiple stress concentration points. For example, the first stress concentration point 270 is visible in Figure 8. In some embodiments of the insert member 246, three stress concentration points may be used, similar to the insert member 146. The application of this force asymmetry is thought to cause an increase in the stress generated in ampoule 242, thereby reducing the amount of force the user must apply to cap 204 to break ampoule 242.

[0070] In embodiments utilizing the first stress concentration area 270, the second stress concentration area, the third stress concentration area, and the arm 251, the ampoule 242 may break after the application of a force to the cap 204 that generates at least five resistance forces at different locations on the ampoule 242. These reaction forces occur at least where (1) the top 243 of the ampoule 242 contacts the cap 204, (2) the ampoule 242 contacts the first stress concentration area 270, (3) the ampoule 242 contacts the second stress concentration area, (4) the ampoule 242 contacts the third stress concentration area, and (5) the arm 251 deforms the stress concentration area 212 within the ampoule 242.

[0071] The relative positions of the arm 251 and the projection 212 can be reversed, so that the projection 212 is closer to the inner side wall 216 than the arm 251, and the arm 251 can contact the ampoule 242 to help maintain its position within the housing 202. In this configuration, when the cap 204 is pressed, the projection 212 applies a lateral force to the arm 251, and then applies a lateral force to the 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 herein. The teachings, expressions, embodiments, examples, etc., described herein should not be considered independently of each other. Various appropriate ways in which the teachings herein can be combined will be apparent to those skilled in the art.

[0073] While illustrative embodiments of the subject matter contained herein have been illustrated and described, further applications of the methods and systems described herein can be achieved by appropriate modifications without departing from the claims. Some such modifications should be obvious to those skilled in the art. For example, the examples, embodiments, geometric figures, materials, dimensions, proportions, processes, etc. described above are illustrative. Therefore, the claims should not be limited to the structural and operational details described in the specification and drawings.

[0074] [Implementation Method] (1) A biological sterilization indicator, (a) A housing having a first enclosure and a second enclosure, (b) An ampoule containing a liquid growth medium, wherein at least a portion of the ampoule is located inside the first enclosure, (c) An insert member that is at least partially disposed in the first enclosure, wherein the insert member is (i) A platform including a top surface, a contact surface, and sides, (ii) A first cavity located on the platform and configured to allow a first amount of the liquid growth medium to pass into the second enclosure, (iii) an insert member comprising a second cavity located 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, A biological sterilization indicator, including... (2) The biological sterilization indicator according to Embodiment 1, wherein the second cavity of the insertion member is an angled notch that passes through the contact surface and the side surface. (3) The biological sterilization indicator according to Embodiment 2, wherein the angled notch of the insertion member is generally positioned below the upper surface. (4) The biological sterilization indicator according to Embodiment 3, wherein the insertion member further includes a wall disposed on the upper surface of the platform. (5) The biological sterilization indicator according to Embodiment 4, wherein the wall has a cylindrical shape.

[0075] (6) A method for using a biological sterilization indicator, (a) To provide the biological sterilization indicator, the biological sterilization indicator is (i) an ampoule containing liquid growth medium, (ii) An insert member that is at least partially disposed inside the first enclosure of the biological sterilization indicator, wherein the insert member is A platform including the top surface, contact surface, and sides, A first cavity is positioned through the platform and configured to allow a first amount of the liquid growth medium to pass into the second enclosure, The insert member includes, having a second cavity located through at least a portion of the aforementioned 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) that the first amount of the liquid growth medium passes through the first cavity, (d) enabling the second amount of the liquid growth medium to pass through the second cavity, Methods that include... (7) The method of embodiment 6, further comprising preventing the formation of a liquid lock. (8) A biological sterilization indicator, (a) A housing having an internal side wall, an internal bottom wall, a first enclosure, a second enclosure, and a support for the internal side wall, wherein the first enclosure is positioned above the support, and the second enclosure is positioned between the internal bottom wall and the support; (b) an ampoule having at least a portion of which is located inside the first enclosure and having a first end and a second end, (c) A cap having an inner surface and an outer surface, which is disposed on a portion of the housing including at least a portion of the first enclosure, (d) A carrier arranged on the inner bottom wall, (e) Insertion member, (i) A platform including a top surface and a contact surface, wherein the second end of the ampoule is positioned on the top surface and the contact surface is positioned on the support, (ii) An insert member including a leg portion extending toward the inner bottom wall, wherein the leg portion has a length shorter than the distance between the support and the inner bottom wall such that there is a gap between the carrier and the leg portion; A biological sterilization indicator, including... (9) The biological sterilization indicator according to Embodiment 8, wherein the length of the leg portion is about 0.1 to 2 millimeters shorter than the distance between the support and the inner bottom wall. (10) The biological sterilization indicator according to Embodiment 9, wherein the upper surface of the platform includes at least three stress concentration areas, and the second end of the ampoule is in contact with each of the at least three stress concentration areas.

[0076] (11) The biological sterilization indicator according to Embodiment 10, wherein the cap further includes an annular projection beginning on the inner surface and extending toward the second enclosure of the housing, and the first end of the ampoule is positioned within the annular projection. (12) The biological sterilization indicator according to embodiment 11, wherein the first end of the ampoule is connected to the annular projection by friction fitting. (13) The biological sterilization indicator according to Embodiment 11, wherein the ampoule has an annular cross-section with an outer diameter about 0.1 to 1 millimeter shorter than the inner diameter of the annular projection. (14) The biological sterilization indicator according to embodiment 11, wherein the inner surface of the cap is in contact with the first end of the ampoule. (15) A biological sterilization indicator, (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 having at least a portion of which is located inside the first enclosure and having a first end and a second end, (c) A cap having an inner surface and an outer surface, which is disposed on a portion of the housing including at least a portion of the first enclosure, (d) Insertion member, (i) A platform, which is disposed on the support, (ii) An insert member having a first stress concentration portion, a second stress concentration portion, and a third stress concentration portion, each of which is positioned on the platform and each is in contact with the second end of the ampoule, A biological sterilization indicator, including...

[0077] (16) The biological sterilization indicator according to embodiment 15, wherein the insertion member further includes a second wall that begins on the platform and extends away from the second enclosure. (17) The biological sterilization indicator according to Embodiment 16, wherein the first stress concentration portion, the second stress concentration portion, and the third stress concentration portion each have a triangular shape including a base portion, a height portion, and a hypotenuse portion, and each base portion contacts the platform, each height portion contacts the second wall, and each hypotenuse portion contacts the second end of the ampoule. (18) The biological sterilization indicator according to Embodiment 17, wherein the angle between the platform and the hypotenuse portion of the first stress concentration portion is different from the angle between the platform and the hypotenuse portion of the second stress concentration portion. (19) The biological sterilization indicator according to Embodiment 18, wherein the angle between the platform and the hypotenuse portion of the first stress concentration portion is different from the angle between the platform and the hypotenuse portion of the third stress concentration portion, and the angle between the platform and the hypotenuse portion of the second stress concentration portion is different from the angle between the platform and the hypotenuse portion of the third stress concentration portion. (20) The biological sterilization indicator according to Embodiment 19, wherein the angle between the platform and the hypotenuse portion of the second stress concentration portion is within approximately 5 degrees of the angle between the platform and the hypotenuse portion of the third stress concentration portion.

[0078] (21) The biological sterilization indicator according to Embodiment 20, wherein the angle between the platform and the hypotenuse portion of the second stress concentration portion is equal to the angle between the platform and the hypotenuse portion of the third stress concentration portion. (22) The cap is movable from a first position to a second position, and the biological sterilization indicator is (a) A projection that begins on the inner surface of the cap and extends toward the insertion member, (b) an arm beginning at the second wall and extending toward the cap, wherein the arm is adapted to prevent movement of the cap by interference with the projection, and the arm is further adapted to move from a first orientation to a second orientation in order to allow movement of the cap to the second position, A biological sterilization indicator according to embodiment 17, further comprising: (23) The biological sterilization indicator according to embodiment 22, wherein the arm includes an opening through the arm and the projection is adapted to move from a third orientation to a fourth orientation. (24) The biological sterilization indicator according to Embodiment 23, wherein the arm is positioned relative to the projection such that the ampoule is positioned to prevent the projection from bending from the third orientation to the fourth orientation. (25) The biological sterilization indicator according to Embodiment 23, wherein the arm is positioned relative to the projection such that the ampoule is positioned to prevent the arm from bending from the first orientation to the second orientation.

[0079] (26) A method for activating a biological sterilization indicator, (a) To provide the biological sterilization indicator, wherein the biological sterilization indicator includes a housing, a cap, an ampoule, and an insertion member, The cap includes an inner surface and a projection that begins on the inner surface and extends toward the insertion member, The insert member includes at least three stress concentration portions and an arm extending toward the cap, The first end of the ampoule is positioned inside the cap, and the second end of the ampoule rests on the at least three stress concentration points. (b) Applying force to the biological sterilization indicator, (c) generating at least five reaction forces at separate locations on the ampoule, Methods that include...

Claims

1. A biological sterilization indicator, A housing having a first enclosure and a second enclosure, An ampoule containing a liquid growth medium, wherein at least a portion of the ampoule is located inside the first enclosure, A cap having a projection that is configured to be movable relative to the housing, An insertion member, at least partially disposed inside both the first enclosure and the second enclosure, having a platform and an arm, engaging with the projection, and configured to generate a lateral force on the ampoule in response to the application of force to the cap, thereby breaking the ampoule and releasing the liquid growth medium; A biological sterilization indicator equipped with the following features.

2. The biological sterilization indicator according to claim 1, wherein the insertion member further includes a wall portion disposed on the upper surface of the platform.

3. The biological sterilization indicator according to claim 2, wherein the wall portion has a cylindrical shape.

4. The biological sterilization indicator according to claim 1, wherein the contact surface of the insertion member contacts the support of the housing.

5. The biological sterilization indicator according to claim 1, further comprising a plurality of stress concentration points configured to generate one or more reaction forces at separate locations on the ampoule.

6. The biological sterilization indicator according to claim 1, wherein the top of the arm is configured to contact the projection.

7. The biological sterilization indicator according to claim 6, wherein, before the force is applied to the cap, there is a gap of about 0.1 mm to 5 mm between the top and the projection.

8. The biological sterilization indicator according to claim 1, wherein the projection is planar, inclined, arched, annular, conical, or a combination thereof.

9. The biological sterilization indicator according to claim 1, wherein the arm is configured to bend when subjected to the force applied to the cap.

10. The biological sterilization indicator according to claim 9, wherein the arm is hollow in order to reduce the force on the cap required to bend the arm.

11. The biological sterilization indicator according to claim 10, wherein the arm comprises at least one channel or at least one opening to reduce the force on the cap required to bend the arm.

12. The biological sterilization indicator according to claim 5, wherein the ampoule is configured to break at one or more locations in response to one or more reaction forces, the one or more locations including the top of the ampoule, where the ampoule contacts one of the plurality of stress concentration areas, or where the arm deflects the projection toward the ampoule.

13. The biological sterilization indicator according to claim 1, wherein the arm is closer to the inner side wall than the projection.

14. The biological sterilization indicator according to claim 1, wherein the projection is closer to the inner side wall than the arm.

15. A method for using a biological sterilization indicator, (a) To provide the biological sterilization indicator, the biological sterilization indicator is (i) An ampoule containing a liquid growth medium, wherein at least a portion of the ampoule is located inside a first enclosure, (ii) A cap having a projection that is movably configured relative to the housing, (iii) an insert member having a platform and arms, which is at least partially disposed inside both the first enclosure and the second enclosure of the biological sterilization indicator. (b) The ampoule is destroyed by applying force to the cap, wherein the projection generates a lateral force on the ampoule in response to the application of the force to the cap, thereby destroying the ampoule and releasing the liquid growth medium, Methods that include...

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