CN110844274A - Ampoule puncturing mechanism for biological indicator - Google Patents

Abstract

The invention relates to a biological indicator for sterilization of medical instruments, in particular to an ampoule piercing mechanism of the biological indicator. Including a metal thimble, the piercing mechanism also includes a spring, an upper filter screen and a lower filter screen; the metal thimble is fixed on the lower filter screen; the spring is arranged between the upper filter screen and the lower filter screen, and the upper end of the spring is connected to the upper filter screen. The nets are in contact with each other, and the lower end of the spring is in contact with the lower filter screen; the upper filter screen is provided with a thimble through hole for the metal thimble to pass through. The invention supports the ampoule on the metal thimble by arranging the upper filter screen and the spring, which can separate the ampoule and the metal thimble at a distance, thereby reducing the risk of accidental puncturing of the ampoule and improving the reliability of the indicator.

Description

Ampoule Piercing Mechanism for Biological Indicators

technical field

The invention relates to a biological indicator for sterilization of medical instruments, in particular to an ampoule piercing mechanism of the biological indicator.

Background technique

Chinese Invention Patent Application Publication Specification CN107823683A discloses a biological indicator with variable resistance, which assists the rupture of ampoules by providing a rupture feature (ie, a piercing mechanism) of a spike. However, the ampoule is supported on a sharp object, and is prone to accidental rupture when it is shaken up and down during handling and storage, resulting in an unusable indicator and poor reliability.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an ampoule piercing mechanism for biological indicators that can improve reliability, comprising a metal thimble, the piercing mechanism further comprising a spring, an upper filter screen and a lower filter screen; the metal thimble is fixed on the lower filter screen The spring is arranged between the upper filter screen and the lower filter screen, the upper end of the spring is in contact with the upper filter screen, and the lower end of the spring is in contact with the lower filter screen; the upper filter screen is provided with a thimble through hole for the metal thimble to pass through .

The invention supports the ampoule on the metal thimble by arranging the upper filter screen and the spring, which can separate the ampoule and the metal thimble at a distance, thereby reducing the risk of accidental puncture of the ampoule and improving the reliability of the indicator.

Description of drawings

Fig. 1 and Fig. 2 respectively show two different perspective perspective views of the biological indicator applied in the present invention;

Fig. 3 and Fig. 4 respectively show the three-dimensional exploded schematic diagram of the biological indicator applied in the present invention from two different angles;

Fig. 5 shows the front view of the biological indicator applied by the present invention;

Fig. 6 shows the A-A sectional view of Fig. 5;

Fig. 7 shows the schematic diagram after each component is separated on the basis of Fig. 6;

Fig. 8 shows a partial enlarged view of part B of Fig. 7;

Fig. 9 and Fig. 10 respectively show the three-dimensional schematic diagram of two different angles of the present invention;

Fig. 11 and Fig. 12 respectively show the three-dimensional exploded schematic diagram of the present invention from two different angles;

The resistance limiting structure shown in FIG. 1 to FIG. 7 is Embodiment 1;

13 shows the front view of the cap and the outer tube when the resistance limiting structure is Embodiment 2;

Figure 14 shows the C-C sectional view of Figure 13;

Fig. 15 shows the schematic diagram after the cap and the outer tube are separated on the basis of Fig. 14;

FIG. 16 shows a perspective exploded schematic view of the cap and the outer tube when the resistance limiting structure is the second embodiment.

10 bacterial tablets;

20 ampoules;

30 Outer tube, 301 Outer tube mouth, 302 Outer tube end wall, 303 Outer tube lumen, 304 End wall through hole, 305 Tube wall gap, 306 Outer surface of outer tube wall, 307 Outer tube wall 308 outer tube elastic hook, 309 outer tube hook head, 310 outer tube hook head blocking plane, 311 outer tube hook head guiding slope, 312 outer tube large diameter section, 313 outer tube small diameter section, 314 outer tube step surface;

40 cap, 401 cap through hole, 402 top cap, 403 side wall, 404 cap opening, 405 cap cavity, 406 cap small diameter section, 407 cap large diameter section, 408 cap step surface, 409 Side wall gap, 410 outer surface of side wall, 411 inner surface of side wall, 412 cap elastic hook, 413 cap hook head, 414 cap hook head guiding slope, 415 cap hook head blocking plane;

50 inner tube, 501 inner tube opening, 502 inner tube end, 503 inner tube lumen, 504 inner tube large diameter section, 505 inner tube small diameter section, 506 inner tube step surface, 507 supporting feet;

80 upper filter screen, 801 thimble through hole;

90 lower filter screen, 901 convex column;

100 telescopic sealing sleeve;

200 elastic seals;

300 sealed spaces.

Detailed ways

As shown in FIG. 1 to FIG. 12 , a biological indicator for sterilization of medical devices includes a container, a bacterial tablet 10 and an ampoule 20 containing a culture medium. The container includes an outer tube 30 and a cap 40 . The upper end has an outer tube mouth 301, the lower end of the outer tube has an outer tube end wall 302, the cap 40 is installed on the upper end of the outer tube 30, and the cap 40 is provided with a cap communicating with the lumen 303 of the outer tube through hole 401;

The biological indicator further includes an inner tube 50, the upper end of the inner tube 50 has an inner tube nozzle 501, and the lower end of the inner tube has an inner tube end wall 502;

The ampoule 20 and the inner tube 50 are both placed in the lumen 303 of the outer tube, the lumen 303 of the outer tube, the mouth 501 of the inner tube and the lumen 503 of the inner tube are sequentially connected, and the ampoule 20 is inserted through the mouth 501 of the inner tube In the lumen 503 of the inner tube, so that the medium released from the ampoule 20 can flow into the lumen 503 of the inner tube, the bacterial tablet 10 is placed in the lumen 503 of the inner tube, and the lumen 503 of the inner tube is Set to be able to hold culture medium;

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

In this technical solution, an end wall through hole is arranged on the end wall of the outer tube, so that the end wall through hole, the lumen of the outer tube and the cap through hole are connected to form a smooth gas flow path, which is convenient for the use of pressure. During the sterilization process of the steam sterilizer, the steam circulates, and the flowing steam enters the lumen of the inner tube through the nozzle of the inner tube to contact the bacteria sheet. The principle of convection can improve the steam circulation effect of the outer tube and the inner tube, so that the bacteria The tablet is in better contact with the steam, making the biological indicator more accurate.

The cap 40 includes 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 has a cap opening 404, the top wall 402 and the side wall 403 define a The cap cavity 405 communicated with the cap opening 404, in this embodiment, the cap through hole 401 is provided 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, there is a restriction structure that allows the upper end of the outer tube to be inserted into the cap cavity and prevents the upper end of the outer tube from being pulled out of the cap cavity.

The technical solution can prevent the cap from accidentally falling off by setting a resistance-limiting structure. The resistance-limiting structure is used in conjunction with the following spring. The elastic force of the spring is sequentially transmitted to the cap through the upper filter screen, the ampoule and the top wall of the cap, and the resistance is limited. The structure can overcome the elastic force of the spring to prevent the cap from being separated from the outer tube.

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

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

The metal thimble 60 is fixed on the lower 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 abuts against the upper filter screen 80, and the lower end of the spring 70 abuts 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.

The piercing mechanism disclosed in this embodiment supports the ampoule on the metal thimble by setting the upper filter screen and the spring, which can separate the ampoule and the metal thimble at a distance, thereby reducing the risk of accidental puncturing of the ampoule. When the medium needs to be released actively, the upper filter screen can be driven to move down against the elastic force of the spring by driving the ampoule downward. The metal thimble penetrates the through hole of the thimble and pierces the lower end of the ampoule to release the medium in the ampoule.

The piercing mechanism further includes a telescopic sealing sleeve 100. In this embodiment, the telescopic sealing sleeve 100 is a corrugated tube, and its material can be rubber or silicone;

The telescopic sealing sleeve 100 is arranged between the upper filter screen 80 and the lower filter screen 90 , the upper end of the telescopic sealing sleeve 100 is fixed to the upper filter screen 80 , the lower end of the telescopic sealing sleeve 100 is fixed to the lower filter screen 90 , and the telescopic sealing sleeve 100 is fixed to the lower filter screen 90 . The sealing sleeve 100 covers the metal thimble 60 and the spring 70. In this embodiment, the lower filter screen 90 is provided with a convex column 901 extending toward the upper filter screen 80, and the metal thimble 60 is fixedly installed on the convex column 901. On the top, 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 the thimble through hole 801, and the upper filter screen 80 moves down and stops when it is in contact with the end face of the convex column 901;

The upper filter screen 80 is provided with an elastic sealing member 200 that closes the thimble through hole 801 and can be pierced by the metal thimble 60 .

The puncturing mechanism disclosed in the technical solution realizes the puncturing of the ampoule during the downward movement of the ampoule. When the ampoule moves down, it drives the upper filter screen to move down against the elastic force of the spring, and the metal thimble penetrates the elastic seal and pierces the lower end of the ampoule to release the medium in the ampoule.

In this embodiment, both the upper filter screen and the lower filter screen are provided with mesh holes that allow the medium to pass through. The upper filter screen and the lower filter screen are arranged to filter the glass slag after the ampoule is broken.

In this embodiment, the material of the spring is metal.

The upper filter screen, the elastic seal, the telescopic sealing sleeve and the lower filter screen define a sealed space 300, and the metal thimble 60 and the spring 70 are placed in the sealed space 300. After being pierced by the elastic seal, the elastic seal can recover by its own elasticity. Under the action of sealing the part pierced by the thimble, the metal thimble is isolated from the bacterial sheet and the medium, avoiding the metal thimble being soaked in the medium, and avoiding the combination of metal ions and the medium components, especially in high (for example, 50 Under the culture temperature environment of 60 degrees), harmful substances are generated and affect the growth of bacteria.

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

The upper end of the ampoule 20 is in contact with the top wall 402 of the cap when the lower end of the ampoule 20 is supported on the upper filter screen 80;

The cap 40 is configured to move toward the lower end of the outer tube relative to the outer tube 30 under the pressing of an external force. Therefore, when the cap is pressed, the ampoule and the upper filter screen are moved downward against the elastic force of the spring, and the metal thimble penetrates the elastic seal and pierces the lower end of the ampoule to release the medium in the ampoule. In addition, when the upper filter screen 80 continues to move down and is in contact with the end face of the convex column 901, the upper filter screen 80 stops moving, and the cap 40 continues to be pressed down at this time. The distance between the top wall of the cap and the upper filter screen Reduced and compressible ampoule to further crush the ampoule.

When the cap is released, the upper filter screen moves up and resets under the elastic force of the spring, the metal thimble is pulled out of the elastic seal, and the elastic seal closes the part pierced by the thimble under the action of its own elastic recovery. Metal thimble isolated.

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 the shape of a stepped hole and includes a large-diameter section 504 of the inner tube and a small-diameter section 505 connected in sequence from the upper end of the inner tube to the lower end of the inner tube. The diameter of the large-diameter section 504 is larger than The diameter of the inner tube small diameter section 505 has an inner tube stepped surface 506 at the junction of the inner tube large diameter section 504 and the inner tube small diameter section 505, and the lower filter screen 90 is pressed against the inner tube stepped surface 506, passing through The step surface of the inner tube supports the lower filter screen, and the bacterial sheet 10 is placed in the small diameter section 505 of the inner tube;

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

In this embodiment, the resistance limiting structure may adopt the following two implementations.

The first implementation of the resistance-limiting structure:

As shown in FIG. 1 to FIG. 7 , the tube wall of the outer tube is provided with a tube wall gap 305, and the tube wall gap 305 penetrates from the outer surface 306 of the tube wall of the outer tube to the inner surface 307 of the tube wall of the outer tube, and The tube wall gap 305 is located at the upper end of the outer tube;

The cap cavity 405 is in the shape of a stepped hole and includes a cap small diameter section 406 and a cap large diameter section 407 connected in sequence from the lower end of the side wall 403 to the upper end of the side wall 403. The diameter of the cap large diameter section 407 is It is larger than the diameter of the small diameter section 406 of the cap and has a cap step surface 408 at the junction of the large diameter section 407 of the cap and the small diameter section 706 of the cap;

The resistance-limiting structure includes an outer tube elastic hook 308 disposed in the tube wall notch 305, and the outer tube elastic hook 308 includes an outer tube hook head 309 protruding from the outer surface 306 of the tube wall of the outer tube;

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

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

The side of the outer tube hook head 309 facing the lower end of the outer tube is the outer tube hook head blocking plane 310 for abutting against the cap step surface 408 , and the outer tube hook head 309 is opposite to the outer tube hook head blocking plane 310 The opposite side is the guide slope 311 of the hook head of the outer tube.

The lower end of the side wall of the cap presses against the guiding slope of the hook head of the outer tube when the upper end of the outer tube is inserted into the cap cavity, so as to elastically deform the elastic hook of the outer tube, and when the elastic hook of the outer tube passes through the small diameter of the cap After reaching the large-diameter section of the cap, the elastic hook of the outer tube is restored.

The second embodiment of the resistance-limiting structure:

As shown in FIG. 13 to FIG. 16 , the side wall 403 of the cap is provided with a side wall notch 409 , the side wall notch 409 penetrates from the outer surface 410 of the side wall to the inner surface 411 of the side wall, and the side wall notch 409 at the lower end of the side wall;

The outer tube 30 is in the shape of a stepped shaft and includes a large-diameter section 312 and a small-diameter section 313 connected in sequence from the upper end of the outer tube to the lower end of the outer tube. The diameter of the large-diameter section 312 is larger than the small-diameter section of the outer tube. The diameter of the section 313 has an outer tube step surface 314 at the junction of the large diameter section 312 of the outer tube and the small diameter section 313 of the outer tube;

The blocking structure includes a cap elastic hook 412 disposed in the side wall notch 409 , and the cap elastic hook 412 includes a cap hook head protruding from the inner surface 411 of the side wall and extending into the cap cavity 405 413;

The upper end of the outer tube is prevented from being pulled out of the cap cavity 405 when the cap hook 413 abuts against the outer tube stepped surface 314 .

In this embodiment, the cap is made of plastic material, and the elastic hook 412 of the cap is integrally formed with the side wall 403 of the cap.

The side of the cap hook head 413 facing the lower end of the side wall is the cap hook head guiding slope 414, and the side of the cap hook head 413 opposite to the cap hook head guiding slope 414 is used for connecting with the outer tube The hook head of the cap against which the stepped surface 314 abuts against the flat surface 415 .

When the outer tube is inserted into the cap cavity 405 , the upper end of the outer tube presses against the cap hook guide slope 414 to elastically deform the cap elastic hook 412 , and passes through the cap elastic hook 412 at the large diameter section 312 of the outer tube. Afterwards, the elastic hook 412 of the cap is restored.

Claims (6)

1. The utility model provides a biological indicator's ampoule punctures mechanism, includes metal thimble, its characterized in that: the puncturing mechanism also comprises a spring, an upper layer filter screen and a lower layer filter screen;

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

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

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

2. A lancing mechanism according to claim 1, wherein:

the puncturing mechanism also comprises a telescopic sealing sleeve;

the telescopic sealing sleeve is sleeved between the upper-layer filter screen and the lower-layer filter screen, the upper end of the telescopic sealing sleeve is fixed on the upper-layer filter screen, the lower end of the telescopic sealing sleeve is fixed on the lower-layer filter screen, and the telescopic sealing sleeve covers the metal thimble and the spring;

an elastic sealing element which seals the thimble through hole and can be pierced by the metal thimble is arranged on the upper filter screen.

3. A lancing mechanism according to claim 2, wherein: the elastic sealing element is a butyl rubber sealing element or a silica gel sealing element.

4. A lancing mechanism according to claim 2, wherein: the puncture mechanism is applied to a biological indicator which comprises an ampoule, wherein the ampoule is supported on an upper filter screen.

5. A lancing mechanism according to claim 4, wherein:

the biological indicator also comprises a container and a bacterial piece, wherein the container comprises an outer tube and a cap, the upper end of the outer tube is provided with an outer tube nozzle, 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, the upper end of the outer tube is inserted into the cap cavity through the cap opening, and the cap is arranged to move relative to the outer tube towards the lower end of the outer tube under the external pressure;

the puncture mechanism is arranged in the tube cavity of the outer tube, and the upper end of the ampoule is supported on the lower end of the ampoule and is propped against the top wall of the cap cover when the upper-layer filter screen is arranged.

6. A lancing mechanism according to claim 5, 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.

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