阅读说明：本技术 生物指示剂的容器 (Container for biological indicator ) 是由 不公告发明人 于 2019-12-02 设计创作，主要内容包括：本发明涉及一种医疗器械灭菌用生物指示剂,尤其是涉及一种生物指示剂的容器。包括外管和帽盖,该帽盖安装于外管的上端,该帽盖上设有与外管的管腔连通的帽盖通孔,该外管的下端具有外管端壁,其特征在于：该外管端壁上设有与外管的管腔连通的端壁通孔。本发明通过在外管端壁上设置端壁通孔,使得端壁通孔、外管的管腔以及帽盖通孔连通而形成一条畅通的气体流路,该气体流路以便于在使用压力蒸汽灭菌器消毒的过程中蒸汽的流通,利用对流原理能够提高外管的蒸汽流通效果,使得置于容器中的菌片与蒸汽能够更充分地接触,使得生物指示剂指示更准确。(The invention relates to a biological indicator for sterilizing medical instruments, in particular to a container of the biological indicator. Including outer tube and cap, this cap is installed in the upper end of outer tube, is equipped with the cap through-hole with the lumen intercommunication of outer tube on this cap, and the lower extreme of this outer tube has outer tube end wall, its characterized in that: the end wall of the outer pipe is provided with an end wall through hole communicated with the pipe cavity of the outer pipe. According to the invention, the end wall through hole is formed in the end wall of the outer pipe, so that the end wall through hole, the pipe cavity of the outer pipe and the cap cover through hole are communicated to form a smooth gas flow path, the gas flow path is convenient for the circulation of steam in the process of using the pressure steam sterilizer for disinfection, the steam circulation effect of the outer pipe can be improved by utilizing the convection principle, the bacterial sheets placed in the container can be in more sufficient contact with the steam, and the biological indicator can be indicated more accurately.)

1. The utility model provides a container of biological indicator, includes outer tube and cap, and this cap is installed in the upper end of outer tube, is equipped with the cap through-hole with the lumen intercommunication of outer tube on this cap, and the lower extreme of this outer tube has outer tube end wall, its characterized in that: the end wall of the outer pipe is provided with an end wall through hole communicated with the pipe cavity of the outer pipe.

2. The container of claim 1, wherein:

the cap comprises a top wall and a side wall, the upper end of the side wall is fixedly connected with the top wall, the lower end of the side wall is provided with a cap opening, the top wall and the side wall define a cap cavity communicated with the cap opening, and the upper end of the outer tube is inserted into the cap cavity through the cap opening;

the cap through hole is disposed on the top wall.

3. The container of claim 2, wherein: a limit structure which allows the upper end of the outer pipe to be inserted into the cap cavity and limits the upper end of the outer pipe to be pulled out of the cap cavity is arranged between the cap and the upper end of the outer pipe.

4. A container according to claim 3, wherein:

the pipe wall of the outer pipe is provided with a pipe wall notch, the pipe wall notch penetrates from the outer surface of the pipe wall of the outer pipe to the inner surface of the pipe wall of the outer pipe, and the pipe wall notch is positioned at the upper end of the outer pipe;

the cap cavity is in a step hole shape and comprises a cap small-diameter section and a cap large-diameter section which are sequentially connected from the lower end of the side wall to the upper end of the side wall, the diameter of the cap large-diameter section is larger than that of the cap small-diameter section, and a cap stepped surface is arranged at the joint of the cap large-diameter section and the cap small-diameter section;

the resistance limiting structure comprises an outer pipe elastic clamping hook arranged in a pipe wall gap, and the outer pipe elastic clamping hook comprises an outer pipe hook head protruding out of the outer surface of the pipe wall of the outer pipe;

the upper end of the outer tube is prevented from being pulled out of the cap cavity when the hook head of the outer tube is abutted against the step surface of the cap.

5. The container of claim 4, wherein: one side of the outer pipe hook head facing the lower end of the outer pipe is an outer pipe hook head blocking plane used for abutting against the step surface of the cap, and one side of the outer pipe hook head opposite to the blocking plane is an outer pipe hook head guiding inclined plane.

6. A container according to claim 3, wherein:

the side wall of the cap is provided with a side wall notch, the side wall notch penetrates from the outer surface of the side wall to the inner surface of the side wall, and the cap notch is positioned at the lower end of the side wall;

the outer pipe is in a stepped shaft shape and comprises an outer pipe large-diameter section and an outer pipe small-diameter section which are sequentially connected from the upper end of the outer pipe to the lower end of the outer pipe, the diameter of the outer pipe large-diameter section is larger than that of the outer pipe small-diameter section, and an outer pipe stepped surface is arranged at the joint of the outer pipe large-diameter section and the outer pipe small-diameter section;

the resistance limiting structure comprises a cap elastic clamping hook arranged in the gap of the side wall, and the cap elastic clamping hook comprises a cap hook head protruding out of the inner surface of the side wall and extending into the cap cavity;

the upper end of the outer tube is prevented from being pulled out of the cap cavity when the hook head of the cap abuts against the step surface of the outer tube.

7. The container of claim 6, wherein: one side of the cap hook head, which faces the lower end of the side wall, is a cap hook head guide inclined plane, and one side of the cap hook head, which is opposite to the cap hook head guide inclined plane, is a cap hook head blocking plane used for abutting against the outer pipe step surface.

8. The container according to claim 4 or 6, wherein: the container is used for biological indicators.

Technical Field

The invention relates to a biological indicator for sterilizing medical instruments, in particular to a container of the biological indicator.

Background

In medical device sterilization processes, biological indicators are commonly used to evaluate the effectiveness of sterilization. Chinese patent application specification CN110055299A discloses a biological indicator for sterilization indication, which comprises a plastic cap, an ampoule, a plastic outer tube and a bacterial sheet. The plastic cap is arranged on the plastic outer pipe to form a container, and the ampoule and the bacterial slices are placed in the container. In order to enable steam to enter the container to contact the bacterial tablets in the sterilization process, the plastic cap is provided with air holes. However, the conventional container is slender and has poor ventilation effect, so that the bacterial tablets are not fully contacted with steam, and the accuracy of indication is influenced.

Disclosure of Invention

The invention aims to provide a container of a biological indicator for sterilization of medical instruments, which can improve indication accuracy, and comprises an outer tube and a cap, wherein the cap is arranged at the upper end of the outer tube, the cap is provided with a cap through hole communicated with a tube cavity of the outer tube, the lower end of the outer tube is provided with an end wall of the outer tube, and the container is characterized in that: the end wall of the outer pipe is provided with an end wall through hole communicated with the pipe cavity of the outer pipe.

According to the invention, the end wall through hole is formed in the end wall of the outer pipe, so that the end wall through hole, the pipe cavity of the outer pipe and the cap cover through hole are communicated to form a smooth gas flow path, the gas flow path is convenient for the circulation of steam in the process of using the pressure steam sterilizer for disinfection, the steam circulation effect of the outer pipe can be improved by utilizing the convection principle, the bacterial sheets placed in the container can be in more sufficient contact with the steam, and the biological indicator can be indicated more accurately.

Drawings

FIGS. 1 and 2 show schematic perspective views of two different angles of a biological indicator for use in the present invention;

FIGS. 3 and 4 are schematic perspective exploded views of two different angles of a biological indicator for use in the present invention;

FIG. 5 shows a front view of a biological indicator for use with the present invention;

FIG. 6 shows a cross-sectional view A-A of FIG. 5;

FIG. 7 shows a schematic illustration of the components of FIG. 6 after separation;

FIG. 8 shows an enlarged view of part B of FIG. 7;

FIGS. 9 and 10 are schematic perspective views of two different angles of a lancing mechanism for biological indicators for use in accordance with the present invention;

FIGS. 11 and 12 are schematic perspective exploded views of two different angles of a lancing mechanism for biological indicators for use in accordance with the present invention;

the resistance limiting structure shown in fig. 1 to 7 is the first embodiment;

FIG. 13 is a front view of the cap and outer tube with the resistance limiting structure in the second embodiment;

FIG. 14 shows a cross-sectional C-C view of FIG. 13;

FIG. 15 shows a schematic view of the cap and outer tube separated from each other on the basis of FIG. 14;

fig. 16 is an exploded perspective view of the cap and the outer tube in the second embodiment of the resistance restricting structure.

10 bacterial slices;

20 ampoules;

30 outer tube, 301 outer tube orifice, 302 outer tube end wall, 303 outer tube lumen, 304 end wall through hole, 305 tube wall gap, 306 outer tube wall outer surface, 307 outer tube wall inner surface, 308 outer tube elastic hook, 309 outer tube hook, 310 outer tube hook blocking plane, 311 outer tube hook guiding inclined plane, 312 outer tube large diameter section, 313 outer tube small diameter section, 314 outer tube step surface;

40 caps, 401 cap through holes, 402 top covers, 403 side walls, 404 cap openings, 405 cap cavities, 406 cap small-diameter sections, 407 cap large-diameter sections, 408 cap step surfaces, 409 side wall notches, 410 side wall outer surfaces, 411 side wall inner surfaces, 412 cap elastic hooks, 413 cap hook heads, 414 cap hook head guide inclined surfaces and 415 cap hook head blocking planes;

the support leg comprises a 50 inner tube, a 501 inner tube opening, a 502 inner tube end, a 503 inner tube lumen, 504 inner tube large diameter section, 505 inner tube small diameter section, 506 inner tube step surface and 507;

80 upper filter screens and 801 thimble through holes;

90 lower layer filter screen, 901 convex column;

100 telescopic sealing sleeves;

200 an elastomeric seal;

300 sealing the space.

Detailed Description

A biological indicator for sterilization of medical instruments as shown in fig. 1 to 12, comprising a container, a bacterial pellet 10 and an ampoule 20 filled with a culture medium, wherein the container comprises an outer tube 30 and a cap 40, the upper end of the outer tube is provided with an outer tube nozzle 301, the lower end of the outer tube is provided with an outer tube end wall 302, the cap 40 is arranged at the upper end of the outer tube 30, and the cap 40 is provided with a cap through hole 401 communicated with a tube cavity 303 of the outer tube;

the biological indicator further includes an inner tube 50, the upper end of the inner tube 50 having an inner tube orifice 501 and the lower end of the inner tube having an inner tube end wall 502;

the ampoule 20 and the inner tube 50 are both arranged in a lumen 303 of the outer tube, the lumen 303 of the outer tube, a nozzle 501 of the inner tube and a lumen 503 of the inner tube are sequentially communicated, the ampoule 20 is inserted into the lumen 503 of the inner tube through the nozzle 501 of the inner tube, so that the culture medium released from the ampoule 20 can flow into the lumen 503 of the inner tube, the fungus piece 10 is arranged in the lumen 503 of the inner tube, and the lumen 503 of the inner tube is arranged to contain the culture medium;

the outer tube end wall 302 is provided with an end wall through hole 304 communicating with the lumen 303 of the outer tube.

This technical scheme is through setting up the end wall through-hole on the outer tube end wall for the end wall through-hole, the lumen and the cap through-hole intercommunication of outer tube form a unblocked gas flow path, this gas flow path so that the circulation of steam in the sterile in-process of use pressure steam sterilizer, the steam that flows is in order to contact with the fungus piece in the lumen that the inner tube mouth of pipe got into the inner tube, utilize the convection current principle can improve the steam circulation effect of outer tube and inner tube, make fungus piece and steam can contact more fully, make biological indicator instruct more accurately.

The cap 40 comprises a top wall 402 and a side wall 403, the upper end of the side wall 403 is fixedly connected with the top wall 402, the lower end of the side wall 403 is provided with a cap opening 404, the top wall 402 and the side wall 403 define a cap cavity 405 communicated with the cap opening 404, and in the embodiment, the cap through hole 401 is arranged on the top wall 402;

the upper end of the outer tube 30 is inserted into the cap cavity 405 through the cap opening 404;

between the cap 40 and the upper end of the outer tube 30, a stopper structure is provided to allow the upper end of the outer tube to be inserted into the cap cavity and to prevent the upper end of the outer tube from being pulled out of the cap cavity.

This technical scheme hinders the structure through setting up the limit and can prevent that the cap from unexpected coming off, should limit to hinder the use of structure cooperation following spring, and the elastic force of spring transmits to the cap through the roof of upper filter screen, ampoule and cap in proper order, and the limit hinders the elastic force that the structure can overcome the spring and avoids the cap to break away from the outer tube.

A puncture mechanism for puncturing the ampoule 20 is arranged in the lumen 503 of the inner tube;

the puncturing mechanism comprises a metal thimble 60, a spring 70, an upper layer filter screen 80 for supporting the ampoule inserted into the lumen of the inner tube, and a lower layer filter screen 90 supported in the lumen 503 of the inner tube;

the metal thimble 60 is fixed on the lower layer filter screen 90;

the spring 70 is arranged between the upper filter screen 80 and the lower filter screen 90, the upper end of the spring 70 is propped against the upper filter screen 80, and the lower end of the spring 70 is propped against the lower filter screen 90;

the upper filter screen 80 is provided with a thimble through hole 801 for the metal thimble 60 to pass through.

Chinese patent application publication CN107823683A discloses a biological indicator with variable resistance that assists in the breaking of an ampoule by providing a breaking feature (i.e., a piercing mechanism) of a spike. However, the ampoule is supported on a pointed object, and is easy to be accidentally broken when being shaken up and down in the carrying and storing processes, so that the indicator cannot be used and the reliability is poor. According to the puncturing mechanism disclosed by the embodiment, the ampoule is supported on the metal thimble by arranging the upper-layer filter screen and the spring, and the ampoule and the metal thimble can be separated by a certain distance, so that the risk of accidental puncturing of the ampoule is reduced, and the reliability of the indicator is improved. When the culture medium needs to be actively released, the ampoule is driven to move downwards to drive the upper filter screen to move downwards to overcome the elastic force of the spring, and the metal thimble penetrates through the thimble through hole to pierce the lower end of the ampoule so as to release the culture medium in the ampoule.

The puncturing mechanism further comprises a telescopic sealing sleeve 100, in the embodiment, the telescopic sealing sleeve 100 is a corrugated pipe, and the material of the corrugated pipe can be rubber or silica gel;

the telescopic sealing sleeve 100 is arranged between the upper-layer filter screen 80 and the lower-layer filter screen 90, the upper end of the telescopic sealing sleeve 100 is fixed on the upper-layer filter screen 80, the lower end of the telescopic sealing sleeve 100 is fixed on the lower-layer filter screen 90, and the telescopic sealing sleeve 100 covers the metal thimble 60 and the spring 70, in the embodiment, the lower-layer filter screen 90 is provided with a convex column 901 extending towards the upper-layer filter screen 80, the metal thimble 60 is fixedly arranged on the convex column 901, the spring 70 is sleeved outside the convex column 901 and the metal thimble 60, the diameter of the convex column 901 is larger than the aperture of a through hole 801 of the thimble, and the upper-layer filter screen 80 moves downwards and stops when the upper-layer filter screen abuts against the end face of the;

the upper filter screen 80 is provided with an elastic sealing element 200 which seals the thimble through hole 801 and can be pierced by the metal thimble 60.

The puncturing mechanism disclosed by the technical scheme realizes the puncturing of the ampoule in the downward moving process of the ampoule. When the ampoule moves downwards, the upper filter screen is driven to move downwards by overcoming the elastic force of the spring, and the metal thimble penetrates through the elastic sealing element to pierce the lower end of the ampoule so as to release the culture medium in the ampoule.

In this example, the upper and lower sieves were provided with mesh openings allowing the passage of the culture medium. The upper filter screen and the lower filter screen are arranged to be capable of filtering glass slag after the ampoule is broken.

In this embodiment, the spring is made of metal.

The upper-layer filter screen, the elastic sealing element, the telescopic sealing sleeve and the lower-layer filter screen define a sealing space 300, the metal thimble 60 and the spring 70 are arranged in the sealing space 300, the part punctured by the thimble can be sealed under the action of self elastic recovery after the elastic sealing element is punctured, so that the metal thimble is isolated from the bacterial sheet and the culture medium, the metal thimble is prevented from being soaked in the culture medium, metal ions are prevented from being combined with the components of the culture medium, and particularly harmful substances are generated under a high (for example, 50-60 ℃) culture temperature environment to influence the growth of bacteria.

In this embodiment, the elastic sealing member is a butyl rubber sealing member or a silicone sealing member.

The upper end of the ampoule 20 is supported against the top wall 402 of the cap when the upper filter screen 80 is supported at the lower end of the ampoule 20;

the cap 40 is arranged to move towards the lower end of the outer tube relative to the outer tube 30 under an external pressure. Therefore, when the cap is pressed, the ampoule and the upper filter screen are driven to move downwards by overcoming the elastic force of the spring, and the metal thimble penetrates through the elastic sealing element to pierce the lower end of the ampoule so as to release the culture medium in the ampoule. In addition, when the upper layer of filter screen 80 moves downwards continuously and abuts against the end face of the convex column 901, the upper layer of filter screen 80 stops moving, at this time, the cap 40 is pressed downwards continuously, the distance between the top wall of the cap and the upper layer of filter screen is reduced, and the ampoule can be compressed to be further compressed and crushed.

When the cap is loosened, the upper filter screen moves upwards under the elastic force of the spring to reset, the metal ejector pin is pulled out of the elastic sealing element, and the elastic sealing element seals the part of the metal ejector pin pierced by the ejector pin under the action of the elastic restoration of the elastic sealing element so as to isolate the metal ejector pin.

The outer diameter of the inner tube 50 is smaller than the diameter of the lumen 303 of the outer tube;

the lumen 503 of the inner tube is in a stepped hole shape and comprises an inner tube large diameter section 504 and an inner tube small diameter section 505 which are sequentially connected from the upper end of the inner tube to the lower end of the inner tube, the diameter of the inner tube large diameter section 504 is larger than that of the inner tube small diameter section 505, an inner tube stepped surface 506 is arranged at the joint of the inner tube large diameter section 504 and the inner tube small diameter section 505, the lower layer filter screen 90 is pressed on the inner tube stepped surface 506, the lower layer filter screen is supported by the inner tube stepped surface, and the mushroom piece 10 is arranged in the inner tube small diameter section 505;

the lower end of the inner tube 50 is provided with support legs 507 which are pressed against the end wall 302 of the outer tube. In this embodiment, three support legs 507 are distributed in a triangular shape, and the support legs 507 can support the inner tube 50 to prevent the end wall of the inner tube from covering the end wall through hole 304 of the outer tube.

In this embodiment, the resistance limiting structure may be implemented as follows.

The first implementation mode of the resistance limiting structure:

as shown in fig. 1 to 7, the tube wall of the outer tube has a tube wall notch 305, the tube wall notch 305 penetrates from the outer surface 306 of the tube wall to the inner surface 307 of the tube wall of the outer tube, and the tube wall notch 305 is located at the upper end of the outer tube;

the cap cavity 405 is in a stepped hole shape and comprises a small cap diameter section 406 and a large cap diameter section 407 which are sequentially connected from the lower end of the side wall 403 to the upper end of the side wall 403, the diameter of the large cap diameter section 407 is larger than that of the small cap diameter section 406, and a cap stepped surface 408 is arranged at the joint of the large cap diameter section 407 and the small cap diameter section 706;

the resistance limiting structure comprises an outer tube elastic hook 308 arranged in the tube wall notch 305, and the outer tube elastic hook 308 comprises an outer tube hook head 309 protruding out of the outer surface 306 of the tube wall of the outer tube;

the upper end of the outer tube 30 is prevented from being pulled out of the cap cavity 405 when the outer tube hook 309 abuts the cap step 408.

In this embodiment, the outer tube is made of plastic, and the elastic hook 308 of the outer tube is integrally formed with the wall of the outer tube.

The outer pipe hook 309 is provided with an outer pipe hook blocking plane 310 on a side facing the lower end of the outer pipe, the outer pipe hook blocking plane being used for abutting against the cap step surface 408, and the outer pipe hook 309 is provided with an outer pipe hook guiding inclined plane 311 on a side opposite to the outer pipe hook blocking plane 310.

The lower end of the side wall of the cap abuts against the outer pipe hook head guide inclined plane when the upper end of the outer pipe is inserted into the cap cavity, so that the outer pipe elastic hook is elastically deformed, and the outer pipe elastic hook is restored after the outer pipe elastic hook reaches the large-diameter section of the cap through the small-diameter section of the cap.

Second implementation mode of the resistance limiting structure:

as shown in fig. 13 to 16, the sidewall 403 of the cap has a sidewall gap 409, the sidewall gap 409 penetrates from the outer surface 410 of the sidewall to the inner surface 411 of the sidewall, and the sidewall gap 409 is located at the lower end of the sidewall;

the outer tube 30 is in a stepped shaft shape and includes an outer tube large diameter section 312 and an outer tube small diameter section 313 which are sequentially connected from the upper end of the outer tube to the lower end of the outer tube, the diameter of the outer tube large diameter section 312 is larger than that of the outer tube small diameter section 313, and an outer tube stepped surface 314 is provided at the joint of the outer tube large diameter section 312 and the outer tube small diameter section 313;

the resistance limiting structure includes a cap elastic hook 412 disposed in the sidewall gap 409, and the cap elastic hook 412 includes a cap hook 413 protruding from the inner surface 411 of the sidewall and extending into the cap cavity 405;

the upper end of the outer tube is restrained from being pulled out of the cap cavity 405 when the cap hook 413 abuts the outer tube step surface 314.

In the present embodiment, the cap is made of plastic, and the elastic hook 412 of the cap is integrally formed with the sidewall 403 of the cap.

A side of the cap hook 413 facing the lower end of the sidewall is a cap hook guide slope 414, and a side of the cap hook 413 opposite to the cap hook guide slope 414 is a cap hook blocking plane 415 for abutting against the outer tube step surface 314.

The upper end of the outer tube presses against the cap hook guide inclined surface 414 when the outer tube is inserted into the cap cavity 405, so that the cap elastic hook 412 is elastically deformed, and the cap elastic hook 412 is restored after the large-diameter section 312 of the outer tube passes through the cap elastic hook 412.