CN1909932A - Sterilizing pretest pack for endoscope - Google Patents

Sterilizing pretest pack for endoscope Download PDF

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Publication number
CN1909932A
CN1909932A CN 200580002136 CN200580002136A CN1909932A CN 1909932 A CN1909932 A CN 1909932A CN 200580002136 CN200580002136 CN 200580002136 CN 200580002136 A CN200580002136 A CN 200580002136A CN 1909932 A CN1909932 A CN 1909932A
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China
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mentioned
pipeline
endoscope
sterilizing
pretest
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CN 200580002136
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Chinese (zh)
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CN100562343C (en
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渡边厚
羽鸟鹤夫
小川晶久
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Olympus Corp
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Olympus Corp
Olympus Medical Systems Corp
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Publication of CN1909932A publication Critical patent/CN1909932A/en
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  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

An endoscope sterilizing test pack (1) includes an indicator (23) for checking a sterilization effect of sterilization treatment, an inner case (3) having an open/close mechanism (fitting member (20), ferrule (19)) which can insert /remove the indicator (23) into/from the inner case, first and second tubes (22A, 22B) substantially hermetically connected to the inner case (3) so that one ends are open at ends of first and second flexible pipes (4A, 4B), respectively, and another ends are communicated to an inside of the inner case (3), an outer case (2) housing the first and the second tubes (22A, 22B) and the inner case (3), and the first and the second flexible pipes (4A, 4B) substantially hermetically connected to the respective ends of the outer case (2) and housing the first and the second tubes (22A, 22B), respectively.

Description

Sterilizing pretest pack for endoscope
Technical field
The present invention relates to a kind of following sterilizing pretest pack: the medical apparatus and instruments (sterilization apparatus) that needs is carried out sterilization processing is housed in the sterilizer, utilize high temperature and high pressure steam sterilization (below, be referred to as the autoclave sterilization), perhaps ethylene oxide gas sterilization (Ethylene Oxide Gas sterilization, below, be referred to as EOG sterilization) etc. sterilizing unit when carrying out sterilization processing, can confirm bactericidal effect, above-mentioned sterilizing unit is by becoming the air displacement in the chamber other gas to sterilize.Be particularly related to the sterilizing pretest pack for endoscope that is used to confirm bactericidal effect that is applicable to endoscope.
Background technology
Need carry out the medical apparatus and instruments (below, be referred to as the apparatus that sterilizes) of sterilization processing, normally be housed in and carry out sterilization processing in the sterilizer, as this sterilization processing method, for example, main usefulness be autoclave sterilization and EOG sterilization processing.
In sterilization processing such as this autoclave sterilization and EOG sterilization, usually, also to confirm operation to whether obtaining sufficient bactericidal effect by this sterilization processing.
Method as in the past affirmation bactericidal effect, adopt autoclave to sterilize and EOG sterilization etc. the sterilization apparatus is carried out under the situation of sterilization processing, for example known method has, by zonal chemical ind (Chemical Indicator:CI) being sticked on the sterilization apparatus, perhaps laminar chemical ind or indicator biology (Biological Indicator:BI) are put into by between the germicide, to confirm bactericidal effect.
In addition, above-mentioned laminar chemical ind or biology indicator confirm the structure of bactericidal effect between being placed on by germicide, that is, so-called test assembly has obtained practicability.This test assembly has been used for autoclave sterilization and EOG sterilization, and the ripple that perhaps is used for carrying out in order to confirm the vacuum type autoclave sterilizer whether residual air to be arranged is according to dick test.
As the prior art of this test assembly, for example, the test assembly in Japanese kokai publication hei 5-253277 communique and Japanese Unexamined Patent Application Publication 2001-526399 communique on the books.
The above-mentioned test assembly that is documented in the Japanese kokai publication hei 5-253277 communique has following part: stratified test bag; Porose reagent paper is keeping the whole stacked effective thin slice of mode, and places between the stratified test bag, is printed on steam sensitivity indication liquid medicine; Some selectable effective layer in this test bag; And the airtight layer of at least one group of atresia, be configured between the porose reagent paper, separated by the porose reagent paper layer of one deck at least, pre-determine efficient by separating by one deck and two-layer porose reagent paper layer at least.
In addition, the above-mentioned assay device that is documented in the Japanese Unexamined Patent Application Publication 2001-526399 communique has following part: pipeline, and make with adiabator, and have inner cavity chamber, in order to add antibacterial, this inner cavity chamber delimit out that an end is opened and the free space of other end sealing; And endothermic section, it is for surrounding the endothermic section of above-mentioned pipeline, in the device use in sterilizer, preferentially accept heat from inner cavity of pipe, thereby in sterilization cycle, the air of the free space that produces by condensing on internal chamber wall and/or by the accumulating of coagulability gas has suppressed the infiltration of sterilization material along inner cavity of pipe.
Patent documentation 1: Japanese kokai publication hei 5-253277 communique
Patent documentation 2: Japanese Unexamined Patent Application Publication 2001-526399 communique
; in above-mentioned confirmation method in the past; if to the sterilization apparatus; be that endoscope carries out after autoclave sterilization or the EOG sterilization etc.; confirm bactericidal effect; then because above-mentioned endoscope has the long pipelines such as passage that are communicated with from the insertion section leading section to operating portion nearby, thus above-mentioned chemical ind or biology indicator to put into the operation of this root pipe interior relatively more difficult.
In addition, the test assembly in the past that above-mentioned Japanese kokai publication hei 5-253277 communique and above-mentioned Japanese Unexamined Patent Application Publication 2001-526399 communique are put down in writing is because the volume of device own is very big, so with above-described the same, can not confirm the bactericidal effect of endoscope.
Summary of the invention
Therefore, the present invention puts forward in view of the above fact, its objective is provides a kind of like this sterilizing pretest pack for endoscope: by structure and the suitable test assembly of endoscope that carries out sterilization processing are set, energy obtains the roughly the same bactericidal effect of bactericidal effect with above-mentioned endoscope, thereby can simply and carry out the affirmation of bactericidal effect reliably.
For achieving the above object, the sterilizing pretest pack for endoscope of the present invention that one of the present invention put down in writing is characterised in that to have following part: inner shell has the switching mechanism that can allow the indicator of the bactericidal effect that is used to confirm that sterilization processing reaches freely come in and go out; At least one pipeline is connected on the above-mentioned inner shell, and an end has the opening that is used to import sterilization gas, the other end and above-mentioned inner shell internal communication; And external packing component, accommodate above-mentioned pipeline and above-mentioned inner shell.
The present invention's two sterilizing pretest pack for endoscope, be also to have following feature in foregoing invention: above-mentioned external packing component has following part: the shell of accommodating the part of above-mentioned inner shell and above-mentioned pipeline; And the pipeline resettlement section that is communicated with and runs through the remainder of above-mentioned pipeline with this shell.
The present invention's three endoscope-use test assembly, be also to have following feature in foregoing invention: above-mentioned pipeline resettlement section forms, and from space outerpace the coefficient of overall heat transmission of the outer surface of the remainder of the above-mentioned pipeline of inleakage is equal to or less than from space outerpace in the coefficient of overall heat transmission as the inner pipeline that forms of endoscope of sterilization processing object.
The present invention's four endoscope-use test assembly, be also to have following feature in foregoing invention: above-mentioned shell forms, and when importing sterilization gas by above-mentioned pipeline, makes the atmosphere that keeps being roughly vacuum around the above-mentioned inner shell.
The present invention's five endoscope-use test assembly is also to have following feature in foregoing invention: above-mentioned pipeline resettlement section has in gastight mode roughly and is connected first, second two flexible pipes on the above-mentioned shell; Above-mentioned first flexible pipe is provided with front end component on its base end part, have the peristome of above-mentioned pipeline on this front end component; And above-mentioned second flexible pipe is provided with back-end component on its end, has the peristome of above-mentioned pipeline on this back-end component, and has the blow vent of check valve or gas.
The present invention's six endoscope-use test assembly, be also to have following feature in foregoing invention: dispose two above-mentioned pipelines, above-mentioned pipeline resettlement section has the single flexible pipe that two above-mentioned pipelines are run through.
The present invention's seven endoscope-use test assembly, be also to have following feature in foregoing invention: above-mentioned pipeline resettlement section is to be formed by the flexible pipe with flexible and free bend, and has the above-mentioned pipeline resettlement section of extending specific length to be organized into the keeper that spiral helicine state keeps.
The present invention's eight endoscope-use test assembly, be also to have following feature in foregoing invention: above-mentioned external packing component forms, at least when importing sterilization gas by above-mentioned pipeline, make above-mentioned inner shell and above-mentioned pipeline around keep the atmosphere of substantial vacuum.
The present invention's nine endoscope-use test assembly, be in foregoing invention, also to have following feature: also have check valve, it utilized before importing sterilization gas by above-mentioned pipeline, the inside of having put into the sterilizer of this sterilizing pretest pack for endoscope is in the negative pressure state this point, discharge above-mentioned inner shell ambient air, and when importing sterilization gas, keep the state of air-out.
The present invention's ten endoscope-use test assembly, be also to have following feature in foregoing invention: an end of above-mentioned pipeline is to the outside opening of above-mentioned external packing component.
Sterilizing pretest pack for endoscope of the present invention, owing to be provided with structure and the suitable test assembly of endoscope that carries out sterilization processing, therefore can obtain and the roughly the same bactericidal effect of bactericidal effect of above-mentioned endoscope, have the advantage that energy be confirmed bactericidal effect simple and reliablely.
Description of drawings
Fig. 1 represents an embodiment of sterilizing pretest pack for endoscope of the present invention, is the integrally-built profile of expression sterilizing pretest pack for endoscope;
Fig. 2 is the profile that expression is housed in the interior shell structure in the shell of Fig. 1;
Fig. 3 is the sketch map of the sterilizing pretest pack for endoscope outward appearance of expression embodiment 2;
Fig. 4 is the sketch map of the sterilizing pretest pack for endoscope internal structure of expression embodiment 2;
Fig. 5 is the sketch map of expression one-way valve structures;
Fig. 6 is the sketch map of the one-way valve structures under the expression open mode;
Fig. 7 is the sketch map of shell structure in the expression;
Fig. 8 is the sketch map of the outward appearance of expression housing body;
Fig. 9 is the sketch map of the structure of expression maintaining part;
Figure 10 represents a sketch map of the state that the loam cake that constitutes shell disassembles from case;
Figure 11 is the sketch map of sterilizing pretest pack for endoscope structure of first variation of expression embodiment 2;
Figure 12 is the sketch map that is used to illustrate the effect of flexible thin;
Figure 13 is the sketch map of sterilizing pretest pack for endoscope outward appearance of second variation of expression embodiment 2;
Figure 14 is the sketch map of the structure of expression keeper;
Figure 15 is the sketch map of structure of keeper of formation sterilizing pretest pack for endoscope of the 3rd variation of expression embodiment 2;
Figure 16 is the partial enlarged drawing of keeper;
Figure 17 is the sketch map of the sterilizing pretest pack for endoscope outward appearance of expression embodiment 3;
Figure 18 is the sketch map of the sterilizing pretest pack for endoscope structure of expression embodiment 3;
Figure 19 is the sketch map of the structure of expression lid, inner shell and connecting portion;
Figure 20 is the sketch map of expression inner shell outward appearance;
Figure 21 is the sketch map of the structure of expression gas introduction part;
Figure 22 is the sketch map of the structure of expression flexible thin;
Figure 23 is the sketch map of the state of the flexible thin of expression when from sterilizer the sterilizing pretest pack for endoscope of embodiment 3 being taken out;
Figure 24 is the sketch map for the effect of the sterilizing pretest pack for endoscope of explanation embodiment 3;
Figure 25 is the sketch map of the variation of expression embodiment 3;
Figure 26 is the sketch map of outward appearance of the sterilizing pretest pack for endoscope of expression embodiment 4;
Figure 27 is the sketch map of outward appearance that the expression housing is in the sterilizing pretest pack for endoscope of open mode;
Figure 28 is the sketch map of expression gas introduction part, pipeline and inner shell annexation each other;
Figure 29 is the sketch map of the structure of expression gas introduction part;
Figure 30 is the sketch map of the structure of expression gas detection section;
Figure 31 is the sketch map of outward appearance of gas introduction part, first pipeline, second pipeline and inner shell of the variation of expression embodiment 4;
Figure 32 represents inner shell and is used for first pipeline, second pipeline are connected to the sketch map of the structure of the connecting portion on the inner shell;
Figure 33 is the sketch map of the outward appearance of expression gas introduction part;
Figure 34 is the sketch map of other variation of embodiment 4;
Figure 35 is the sketch map of other variation of embodiment 4.
Label declaration:
1: sterilizing pretest pack for endoscope, 2: shell, 2A: opening, 2B: opening, 2a: connecting portion, 3: inner shell, 4A: first flexible pipe, 4B: second flexible pipe, 5,6: connector portions, 5A: through hole, 5a: threaded portion, 5b: annular groove, 5c, 11b: screw, 6A: through hole, 6b: annular groove, 6d: threaded portion, 7: stop component, 7a: threaded portion, 8,10,21:O shape sealing ring, 11: sub-joint portion, 11A: through hole, 11a: threaded portion, 13: support unit, 14A, 14B: fixing holding member, 15,16: screw, 17: back-end component, 17A: check valve, 18: housing body, 19: connector portions, 19A: connecting portion, 19B: fixed part, 19C: through hole, 19D: maintaining part, 19a: fixed part, 19b: annular groove, 20: gomphosis part, 20A: first pipeline, 20B: second pipeline, 20a: threaded portion, 23: indicator, 26: shell, 27: pipeline resettlement section, 28: check valve, 29: connecting portion, 30: case, 31: loam cake, 33: inner shell, 34: maintaining part, 34a: maintaining part main body, 34b, 34c: fin, 34d: housing insertion section, 34e: blow vent, 35: gas detection section, 36:O shape sealing ring, 37: flexible pipe, 38: the first flexible pipes, 39: the second flexible pipes, 40: gas introduction part, 40a: gas introduction port, 41: inner shell, 42: leading section, 44: body shell, 45: piston, 46: spring members, 47:O shape sealing ring, 49: indicator, 50: housing body, 50a: narrow slit, 51: cap, 52: connecting portion, 55: case, 56: flexible thin, 58: keeper, 58a: insert logical portion, 58b: connecting portion, 58c: pipeline, 59: top annular element, 60: below annular element, 61: maintaining part, 62: accommodate parts, 63: push part, 65: housing, 66: check valve, 67: lid, 67a: seal member, 68: gas introduction part, 68a: connect with projection, 68b: through hole, 69: flexible thin, 70: pipeline, 71: inner shell, 71a: seal member, 71b: narrow slit, 72: connecting portion, 72a: connect with projection, 72d: through hole, 72e: through hole, 73: indicator, 74: housing, 75: lower house, 75a: recess, 76: upper shell, 76a: recess, 77: hasp, 78: gas introduction part, 78a: main body, 78b, 78c: disc-shaped part, 78d: connect with projection, 78e: gas introduction port, 79: check valve, 80: pipeline, 80: the order pipeline, 81: inner shell, 82: seal member, 83: gas detection section, 85: the resettlement section, 86: indicator, 88: gas introduction part, 88a: main body, 88b: disc-shaped part, 89: the first pipelines, 90: the second pipelines, 91: inner shell, 91b, 91c: seal member, 92,93: connecting portion
The specific embodiment
Below, with reference to accompanying drawing, embodiments of the invention are described.In addition, in the present invention, being used for the germ-resistant high temperature and high pressure steam of autoclave and being used for the germ-resistant ethylene oxide gas of EOG (Ethylene Oxide Gas) etc., the gas that uses when apparatus is carried out sterilization processing is referred to as sterilization gas.In following embodiment, define too and describe.
Embodiment 1
Fig. 1 and Fig. 2 represent an embodiment of sterilizing pretest pack for endoscope of the present invention, the integrally-built profile of Fig. 1 (A) expression sterilizing pretest pack for endoscope, the figure of the connecting portion that Fig. 1 (B) expression is seen from the arrow A direction of Fig. 1 (A), Fig. 2 are the profiles that expression is housed in the interior shell structure in the shell of Fig. 1.
Shown in Fig. 1 (A), sterilizing pretest pack for endoscope 1 has following part: shell 2; Can be housed in the inner shell 3 in this shell 2 with loading and unloading; First, second flexible pipe 4A, 4B, be configured in the both sides of above-mentioned shell 2, respectively by constituting, play a role as an example of the pipeline resettlement section in claims with the roughly same shape (diameter) of the not shown endoscope insertion part that carries out sterilization processing, structure, material; Two connector portions 5,6 are inlaid in the both sides of above-mentioned shell 2, are separately installed with above-mentioned first, second flexible pipe 4A, 4B; And above-mentioned inner shell 3 remained fixed in support unit 13 in the above-mentioned shell 2.
Above-mentioned shell 2 has opening 2A, opening 2B in its both sides.Above-mentioned connector portions 5 is inlaid on the side opening 2A by stop component 7.This connector portions 5 is by being arranged among the annular groove 5b as the O-ring seals 8 of seal member, is inlaid on the above-mentioned shell 2 in gastight mode roughly, and above-mentioned annular groove 5b is located on the part of outer peripheral face of connector portions 5.Above-mentioned stop component 7 has threaded portion 7a on the side face within it, screws by this threaded portion 7a and the threaded portion 5a that is arranged on the base end side of above-mentioned connector portions 5, and the above-mentioned connector portions 5 that is connected with the above-mentioned first flexible pipe 4A is fixed and held on the above-mentioned shell 2.
In addition, connector portions 5 portion within it has through hole 5A, and is connected with the above-mentioned first flexible pipe 4A in the mode that is communicated with this through hole 5A.In addition, the first pipeline 22A of inner shell 3 described later passes the shell side base end part of the first flexible pipe 4A and connector portions 5.
On the other hand, above-mentioned connector portions 6 is inlaid on another opening 2B of above-mentioned shell 2.On this connector portions 6, fixing the screw 9 that stops that shell 2 rotates.On this shell 2, be provided with breach 2a, under the state of the aligned in position of this breach 2a and screw 9, carry out setting-in (referring to Fig. 1 (B)).In addition, by means of O-ring seals (seal member) 10 being arranged among the annular groove 6b that is provided with on the part of the outer peripheral face of shell 2 inboards, this connector portions 6 just is inlaid on the above-mentioned shell 2 in gastight mode roughly.
Above-mentioned connector portions 6 portion within it has through hole 6A, and sub-joint portion 11 just is installed among this through hole 6A.There is threaded portion 11a in this sub-joint portion 11 on outer peripheral face, screw by this threaded portion 11a and the threaded portion 6d that is arranged on the inner peripheral surface of above-mentioned through hole 6A, and sub-joint portion 11 just is installed in the above-mentioned connector portions 6.In this case, by means of O-ring seals (seal member) 12 is arranged among the annular groove 11c, this sub-joint portion 11 just is inlaid on the above-mentioned connector portions 6 in gastight mode roughly, and above-mentioned annular groove 11c is located on the part of base end side outer peripheral face of sub-joint portion 11.In addition, the second pipeline 22B of aftermentioned inner shell 3 passes the second flexible pipe 4B and sub-joint portion 11.
Above-mentioned support unit 13 is to make tabular parts, is provided with hole 13a, 13a that screw is used on the base end part of both sides., and screw respectively in screw 5c, the 11b of connector portions 5 and sub-joint portion 11 with hole 13a, 13a by these two screws, this support unit 13 is fixed in above-mentioned connector portions 5, the sub-joint portion 11 by means of screw 15,15.In addition, support unit 13 in the central near, the screw that is provided with arranged spaced in accordance with regulations is with hole 13b, 13b.With hole 13b, 13b, and by means of the screwing of screw 16,16,13 pairs of this support units are used for fixing the fixedly holding member 14A, the 14B that keep above-mentioned inner shell 3 to be fixed by these screws.
Back-end component 17 is installed on the base end part of the above-mentioned second flexible pipe 4B in gastight mode roughly.This back-end component 17 has the check valve 17A with the internal communication of the above-mentioned second flexible pipe 4B.That is, when negative pressure, this check valve 17A functions as follows: can be discharged to the outside to the air in the above-mentioned first flexible pipe 4B, and the blocking-up air of coming in from the outside.
In addition, on the base end part of the above-mentioned first flexible pipe 4A, be provided with front end component 24.
In addition, in the present embodiment, the structure that is provided with the back-end component 17 with above-mentioned check valve 17A has been described, but, present embodiment is not limited in this, also can save this check valve 17A, and the steam inlet that formations such as use lid can be opened arbitrarily, so that base end part is with first, second flexible pipe 4A, 4B opening.In addition, check valve 17A and steam inlet are not limited on back-end component, also can be arranged on front end component 24, shell 2, first, second flexible pipe 4A, 4B etc. to carry out on the same position of the endoscope of sterilization processing.
Then, with reference to Fig. 2, the concrete structure of above-mentioned inner shell 3 is described.
As shown in Figure 2, inner shell 3 has following part: form columniform housing body 18; Connector portions 19,19 is arranged in the base end part of housing body 18 with air tight manner roughly, to stop up the both-side opening portion of this housing body 18; Gomphosis part 20,20 is used for these two connector portions 19,19 are installed in the base end part of above-mentioned housing body 18 both sides in the mode that can load and unload, and it is fixed and keeps; And first, second pipeline 22A, 22B, being installed in respectively on the above-mentioned connector portions 19,19, roughly the same material, diameter, length and the structure of pipeline (pipeline) that adopts and be carried out endoscope's (not shown) of sterilization processing forms.
Above-mentioned housing body 18 has threaded portion 18a, 18a on the base end part outer peripheral face of both sides, by the threaded portion 20a, the 20a that are arranged on each inner peripheral surface of above-mentioned gomphosis part 20,20, screw on these two threaded portion 18a, 18a, thereby these two gomphosis parts 20,20 and connector portions 19,19 are installed together.
Above-mentioned gomphosis part 20,20 portion within it has connector portions 19,19 respectively.Flange shape abutting part 19a is arranged on this connector portions 19, above-mentioned connector portions 19 is inlaid in housing body 18, and fastening above-mentioned gomphosis part 20, thereby above-mentioned abutting part 19a just is pressed on the end face of housing body 18, be subjected to the pushing of gomphosis part 20, fix above-mentioned abutting part 19a thus.
By means of O-ring seals (seal member) 21,21 is arranged among annular groove 19b, the 19b, above-mentioned connector portions 19,19 just is inlaid in respectively in the above-mentioned housing body 18 in gastight mode roughly, and above-mentioned annular groove 19b, 19b are arranged on the part of housing body side group end outer peripheral face.
And, above-mentioned connector portions 19,19 respectively within it portion through hole 19C, 19C are arranged, and be connected with above-mentioned first, second pipeline 22A, the 22B that is communicated with these two through hole 19C, 19C.By the first pipeline 22A is wrapped in the leading section that forms taper of above-mentioned connector portions 19, and with the tapered cylindrical shape fixed part 19B of the fastening inner peripheral surface of the nut of connecting portion 19A, thereby the above-mentioned first pipeline 22A is fixed on the above-mentioned connector portions 19.In addition, maintaining part 19D is the parts that are used for preventing the first pipeline 22A bendings such as heat shrink tunnel.In addition, for the above-mentioned second pipeline 22B, be fixed on too on the connector portions 19.Like this, above-mentioned first, second pipeline 22A, 22B are just by means of above-mentioned connecting portion 19A, 19A, and being fixed airtightly conscientiously and roughly remains on the above-mentioned gomphosis part 20,20.
The other end of above-mentioned first, second pipeline 22A, 22B is connected on the joint of being located on front end component 24, the back-end component 17 in gastight mode roughly.On back-end component 17 and front end component 24, be formed with the gas feed that is used to guide sterilization gas and steam etc., i.e. opening 17a, 24a, it is last and be communicated with it that the other end of pipeline 22A, 22B then is bonded in these two opening 17a, 24a by means of bonding agent etc.In addition, adhering method also can be, the dismountable method that is connected with connector portions 19 as above-mentioned first, second pipeline 22A, 22B.That is, in this structure, first, second pipeline 22A, 22B, connector portions 19, the inner peripheral surface of housing body 18, with the external communications of sterilizing pretest pack for endoscope 1, and the steam during with the sterilization that directly entered by through hole directly contacts with gas.
In addition, first, second pipeline 22A, 22B, connector portions 19, the outer peripheral face of housing body 18, and shell 2, the inner space of first, second flexible pipe 4A, 4B is the inside of sterilizing pretest pack for endoscope 1, inside roughly is gastight state.
Above-mentioned indicator 23, for example use laminar chemical ind (Chemical Indicator:CI), perhaps use laminar indicator biology (Biological Indicator:BI), the bactericidal effect when these indicators are used to confirm sterilization processing.
In addition, in the present embodiment, be not limited to above-mentioned indicator,, can use so long as be contained in the indicator of housing body 18 internal energy affirmation bactericidal effects.
In addition, the transparent component of above-mentioned housing body 18 indicator 23 that for example also can use a glance just can confirm the to be accommodated bactericidal effect of indicating constitutes.
By means of said structure, above-mentioned inner shell 3 begins the pipeline that the opening 17a of inner face, the back-end component 17 of through hole, the second pipeline 22B of inside, the connector portions 19 of through hole, the housing body 18 of inner face, connector portions 19 by the first pipeline 22A is communicated with for the opening 24a from front end component 24.In addition, the structure of above-mentioned inner shell 3 is that housing body 18 is configured near the substantial middle of the whole inner shell 3 that comprises first, second pipeline 22A, 22B.That is, above-mentioned inner shell 3 constitutes: carrying out under the situations such as autoclave sterilization or EOG sterilization, the position configuration of indicator 23 on the opening position farthest of the front end component 24 of above-mentioned pipeline or back-end component 17.
Also have, various conditions such as the length of above-mentioned first, second pipeline 22A, 22B, diameter, material suitably form corresponding to the endoscope that carries out sterilization processing, perhaps also can constitute according to the condition of needed time of sterilization processing.Specifically, for example can make with adiabatic, the different material of heat dispersion, so that sterilization process is when beginning, temperature in the housing body 18 is lower a little than the ducts of endoscope temperature inside of carrying out sterilization processing, perhaps, also can get the time set of sterilization process longer in order to obtain the bactericidal effect identical with the endoscope that carries out sterilization processing.In addition, also can be such structure, that is, make the length of pipeline longer, and make the diameter of pipeline littler.
In addition, in the inside of sterilizing pretest pack for endoscope 1,, can also dispose other inner matters such as other pipeline and optical fibers, cable, coil, electric wire according to the endoscope that carries out sterilization processing.Can make the volume of first, second flexible pipe 4A, 4B inboard and flowing of the steam when importing germicide vapor in the inside of sterilizing pretest pack for endoscope 1 sterilizes so more near the endoscope that carries out sterilization processing.
In addition, in the sterilizing pretest pack for endoscope of present embodiment, setting that can be such: above-mentioned shell 2 is external packing components of endoscope; Above-mentioned first, second pipeline 22A, 22B are the pipelines that passes endoscope inside; Space between above-mentioned shell 2 and the above-mentioned inner shell 3 is the inner space of the endoscope that sealed by external packing component.
Then, see figures.1.and.2, the effect of the sterilizing pretest pack for endoscope of present embodiment is described.
At first, use the sterilizing pretest pack for endoscope 1 shown in Fig. 1, confirm to carry out autoclave sterilization or the germ-resistant bactericidal effect of EOG.Operator's pivot stop parts 7 also disassemble it, again shell 2 forward end directions are moved and disassemble.Then, screw 16 is disassembled from support unit 13, more fixing holding member 14A is unloaded down.
Then, the operator chemical ind or biology indicator etc. indicator 23 be housed in the inner shell shown in Figure 23.At this moment, the operator rotates the either party's gomphosis part 20 shown in Fig. 2 on one side, Yi Bian it is disassembled, again connector portions 19 is disassembled, the indicator 23 of corresponding kind is contained in the housing body 18, and then above-mentioned connector portions 19 is installed on the housing body 18 with gomphosis part 20.Like this, housing body 18 is inner just to be sealed by separately O-ring seals 21, is contained in its inner indicator 23, with roughly the same the imposing a condition of the pipeline of the endoscope that carries out sterilization processing, perhaps under the needed time conditions of sterilization processing, dispose.
Then, the operator inserts above-mentioned inner shell 3 in the shell 2 shown in Fig. 1 as the crow flies, not allow it be blocked by inner matter.
And operator's pivot stop parts 7 and it is carried out fastening, thereby fix shell 2.
Then, the operator the sterilizing pretest pack for endoscope 1 of Fig. 1 in the pallet or box of expression accommodated in the drawings by the endoscope that carries out sterilization processing, after pallet or box being wrapped with retort pouch and infantees, accommodate in the sterilizer of not representing in the drawings, it is carried out known autoclave sterilization, perhaps EOG sterilization processing.In addition, in the present embodiment,, it is desirable to suitably implement ripple under the germ-resistant situation of vacuum type high steam carrying out according to dick test as sterilization processing.In this case, can replace being applicable to the indicator of ripple with above-mentioned indicator 23, and it is housed in the above-mentioned inner shell 3 according to dick test.
After sterilization processing finishes, the operator with the opposite order of situation that above-mentioned inner shell 3 is housed in the shell 2, the indicator 23 of being accommodated is taken out the effect of affirmation sterilization processing from inner shell 3.
In this case, because above-mentioned sterilizing pretest pack for endoscope 1 constitutes, the condition (temperature and gas concentration) of this inner shell 3 inside is roughly the same with the condition of the pipeline inside of the endoscope that carries out sterilization processing, so can confirm and the roughly the same bactericidal effect of bactericidal effect that in fact carries out the endoscope of sterilization processing by this indicator 23.
In addition, in the present embodiment, also can have such structure, that is,, determine whether to possess the check valve 17A of above-mentioned back-end component 17 according to the endoscope that carries out sterilization processing.Promptly, if carry out the endoscope of sterilization processing is to allow steam enter the type of carrying out sterilization processing between flexible pipe and the pipeline (passage), as long as just steam is set enters the hole, and above-mentioned check valve 17A need be set, enter the hole by means of above-mentioned steam, make the zone and the external communications of the inside of pipeline (pipeline that also comprises first, second pipeline 22A, 22B) in the above-mentioned inner shell 3, shell 2 and first, second flexible pipe 4A, 4B inside, carry out sterilization processing then.
In addition, on the contrary, if carry out the endoscope of sterilization processing is not allow steam enter the type of carrying out sterilization processing between flexible pipe and the pipeline (passage), above-mentioned check valve 17A then is set as shown in Figure 1, make the zone of the inside of pipeline (pipeline that also comprises first, second pipeline 22A, 22B), shell 2 of above-mentioned inner shell 3 inside and first, second flexible pipe 4A, 4B inside, only when negative pressure and external communications, carry out sterilization processing then.
Therefore, according to present embodiment,, just can obtain and the bactericidal effect roughly the same, and can simply and carry out the affirmation of bactericidal effect effectively the bactericidal effect of above-mentioned endoscope by means of being provided with and the suitable test assembly of endoscope structure that carries out sterilization processing.
In addition, the present invention is not limited in above-described embodiment, under the prerequisite that does not break away from the invention aim, can carry out various distortion.
Embodiment 2
The embodiment 2 of sterilizing pretest pack for endoscope of the present invention then, is described.The sterilizing pretest pack for endoscope of embodiment 2 has such structure,, has the single pipeline resettlement section of accommodating two pipelines that is.Below, to Figure 10, present embodiment 2 is described with reference to Fig. 3.
Fig. 3 is the sketch map of the sterilizing pretest pack for endoscope outward appearance of expression embodiment 2.As shown in Figure 3, the sterilizing pretest pack for endoscope of present embodiment 2 has following part: shell 26 is used for accommodating the inner shell 33 (not representing at Fig. 3) that inside contains indicator; Accommodated the pipeline resettlement section 27 of first pipeline 38 and second pipeline 39 (in Fig. 3, not representing); Check valve 28 before importing sterilization gas, makes the inner space of shell 26 and the inner space of pipeline resettlement section 27, that is, make inner shell 33 around and first, second pipeline (aftermentioned) roughly become vacuum on every side; And connecting portion 29, pipeline resettlement section 27 and shell 26 are roughly coupled together airtightly.
Fig. 4 is the sketch map of the sterilizing pretest pack for endoscope internal structure of expression embodiment 2.As shown in Figure 4, the sterilizing pretest pack for endoscope of present embodiment 2 has in shell 26 inside: inner shell 33; The maintaining part 34 that keeps inner shell 33; And the gas detection section 35 that detects the sterilization gas leakage.In addition, pipeline resettlement section 27 has following part: flexible pipe 37, and by connecting portion 29, its inner space is communicated with the inner space of shell 26, and runs through first pipeline 38 and second pipeline 39; Gas introduction part 40,41 has sterilization gas is imported gas introduction port 40a, 41a in first pipeline 38 and second pipeline 39; And leading section 42, be connected with the end of flexible pipe 37, and have from the gap (aftermentioned) of external lid flexible pipe 37 inside and the function that keeps gas introduction part 40,41.
Flexible pipe 37 has such structure: have flexiblely, constitute with parts that can free bend, have first pipeline 38 and second pipeline, 39 these two pipelines that pipeline can pass.In present embodiment 2, the internal diameter of the pipeline that forms in flexible pipe 37 forms more much greatly than the external diameter of first pipeline, 38 grades, so that at the outer surface of first pipeline 38 and the outer surface of second pipeline 39, and produces the space between the inner surface of flexible pipe 37.On the one hand, function by means of leading section 42 grades, this space and space outerpace are isolated, on the other hand, by connecting portion 29, above-mentioned space is communicated with the inner space of shell 26, and by means of the effect of check valve 28, when the inner space of shell 26 became the substantial vacuum atmosphere, the space part of flexible pipe 37 inside also became the atmosphere of substantial vacuum.
In addition, the same with embodiment 1, though flexible pipe 37 also can be made of shape (diameter), structure and the material identical with the insertion section of endoscope, but, if the rising of first pipeline 38 and the inner wall temperature of second pipeline 39 is identical with the situation of using endoscope insertion part, perhaps compare temperature and be difficult for rising, then also can use other tubular part with this situation.
The same with the second pipeline 22B with the first pipeline 22A among the embodiment 1, first pipeline 38 and second pipeline 39 are the parts that are used in the indicator of sterilization gas importing inner shell 33.Sterilizing pretest pack for endoscope in the present embodiment 2 is the parts that are used to confirm whether to have carried out reliably sterilization processing when endoscope is carried out sterilization processing.Therefore, in present embodiment 2, first pipeline 38, second pipeline 39 have respectively with as the corresponding structure of pipeline that is possessed by the endoscope inside of germicide, and sterilization gas arrive dispose indicator the zone (promptly, the interior zone of inner shell 33) condition, with arrive identical, perhaps also strict than it as the condition of the pipeline mid point that forms on by the endoscope of germicide.In addition, about the contact performance between the interior week of the periphery of first pipeline 38 and second pipeline 39 and flexible pipe 37, only however influence the rising of pipe temperature and sterilization gas by pipe interior pass through bactericidal effect such as performance, no matter be to contact, or contactless state can.
Shell 26 also is used to make the atmosphere that keeps regulation on every side when importing sterilization gas of inner shell 33 when accommodating the inner shell 33 that is built-in with indicator, be the atmosphere that keeps substantial vacuum in present embodiment 2.Specifically, shell 26 has: the case 30 of accommodating inner shell 33; And by means of screw thread in conjunction with etc. be formed at loam cake 31 on the case 30 with freely loading and unloading.In addition, in installation process, in case 30 and the part that loam cake 31 contacts, disposed O-ring seals 36, loam cake 31 is by means of the effect of O-ring seals 36, is fixed in gastight mode roughly and accommodates on the shell 30.
Being configured in the gas detection section 35 in the shell 26, is the parts that are used for judging following situation: whether the sterilization gas that imports in the inner shell 33 by first pipeline 38 and second pipeline 39 leaks into inner shell 33 outsides; Perhaps because the air-tightness of certain parts is impaired, whether sterilization gas invades test assembly inside from the outside by beyond thought part.Specifically, gas detection section 35, be by indicators such as sign that has applied the chemical drugs that the sterilization gas as detected object is responded or CI, and the mechanism of accommodating indicator constitutes, it has following function: when sterilization gas leaks into inner shell 33 outside, by the reaction of indicator for displaying regulation, detect the leakage and unexpected intrusion of sterilization gas.
In addition,, judge whether the leakage and unexpected intrusion of sterilization gas,, can both reclaim at an easy rate on the position of indicator so gas detection section 35 preferably is configured in when sterilization processing finishes owing to be preferably in when carrying out each time sterilization processing.Therefore, in present embodiment 2, adopted it is configured in structure on the inner surface of the loam cake 31 that constitutes shell 26.Be configured under this locational situation, for example, comparing with the situation on the bottom that is configured in case 30, loam cake 31 when case 30 disassembles, just can reclaim indicator easily.
Then, the check valve 28 that is configured on the shell 26 is described.The same with embodiment 1, check valve 28 is to make the inner space of shell 26 roughly be varied to vacuum, and keeps the parts of the atmosphere of this substantial vacuum.Generally, indoor the sterilization gas introduction chamber after the sterilizer volume inside zone (that is, chamber in) of having put into endoscope (and sterilizing pretest pack for endoscope) is evacuated, carry out the sterilization processing of endoscope thus.Because check valve 28 has the function that gas is only passed through to the spatial direction in outside from the inside of shell 26, so have following function, the evacuation operation of in the process of sterilization processing, being carried out, gas in the shell 26 is discharged to space outerpace, thereby form the atmosphere of substantial vacuum, and after being evacuated, in the time of in sterilization gas is imported into chamber, by valve-off, make the inner space of the inner space of shell 26 and pipeline resettlement section 27 keep the atmosphere of substantial vacuum.
Fig. 5 is the sketch map of the structure of expression check valve 28.As shown in Figure 5, check valve 28 has following part: body shell 44 is formed with the through hole of the inner space that is communicated with space outerpace and shell 26 (case 30); Piston 45 is configured in the through hole that is formed on the body shell 44 with being free to slide, and has piston main body 45a; Spring members 46 applies elastic force to the direction (below among Fig. 5) near shell 26 (case 30) to piston 45; As the part of piston 45, be used to dispose the spring backstopping assembly 45b of spring members; And when valve closing, be used to make roughly keep gastight O-ring seals 47 between piston 45 and the body shell 44.
Piston main body 45a has: large diameter part is formed with the groove that disposes O-ring seals 47; And small diameter part, its external diameter is littler than large diameter part, on the end can with spring backstopping assembly 45b screw threads for fastening, and small diameter part around dispose spring members 46.Spring backstopping assembly 45b has formed screw in the central, and by this screw, spring backstopping assembly 45b screw threads for fastening is on the end of piston main body 45a.The active force that is configured in the small diameter part spring members 46 on every side of piston main body 45a is set at, the strength that check valve 28 can both be worked under any pressure.The through hole that forms on body shell 44 comprises with corresponding first space, position of the large diameter part of piston main body 45a with as second space of the part of configuration spring members 46.Internal diameter between first, second space forms, and the small diameter part of piston main body 45a can pass, and large diameter part can not pass.That is, spring members 46 is configured in second space, the state of being clamped by spring backstopping assembly 45b and body shell 44.Under externally spatial force value and the identical or higher situation of the pressure of the inner space of shell 26, piston 45 is by being subjected to the active force towards shell 26 1 sides by spring members 46, thereby as shown in Figure 5, the first spatial inclined plane that forms on body shell 44 closely contact with O-ring seals 37, blocks being communicated with between the inner space of space outerpace and shell 26.Usually, just be in the state (valve closing state) of this blocking-up.
On the other hand, before importing sterilization gas, carry out the evacuation operation in, to the space outerpace side shifting, remove the tight contact condition (valve open state) of the first spatial rake and O-ring seals 47 by means of piston.Fig. 6 is the sketch map of this state of expression.In the evacuation operation, externally in the space, by means of the effect of specified vacuum pump etc. gas is discharged to the outside, so the pressure in the space outerpace is lower than the pressure in the inner space of shell 26.Therefore, as the external force that acts on the piston 45, the pressure that is present in the gas in the inner space of shell 26 is dominant, piston 45 moves to outside direction in space (top among Fig. 6), the first spatial rake that forms on body shell 44 and the tight contact condition of O-ring seals 47 are disengaged, and the inner space of space outerpace and shell 26 is communicated with gap between the piston 45 by through hole.Owing to carry out evacuation with respect to space outerpace, so shell 26 gas inside are discharged to space outerpace by after the gap, the inner space of shell 26 roughly becomes the atmosphere of vacuum.
In addition, as mentioned above, when carrying out sterilization processing, after finishing the evacuation operation, just import sterilization gas with sterilizer.; because in this operation; the force value of space outerpace is bigger than the pressure (atmosphere of substantial vacuum) of the inner space of shell 26; so piston 45 just maintains the first spatial rake that is formed in the body shell 44 and O-ring seals 47 tight state of contact (promptly; state shown in Figure 5); space outerpace is not communicated with the inner space of shell 26, during the importing operation of sterilization gas, is still keeping in the interim substantial vacuum atmosphere that forms in the inner space of shell 26.
Then, the inner shell 33 that is housed in shell 26 inside is described.The same with the inner shell 3 among the embodiment 1, inner shell 33 is keeping indicator in inside, this indicator is used for judging as whether having been carried out reliable sterilization processing by the endoscope of germicide, and inner shell 33 is the parts that are used for importing to this indicator sterilization gas by first pipeline 38 and second pipeline 39.
Fig. 7 is the sketch map of the structure of expression inner shell 33.As shown in Figure 7, inner shell 33 has following each several part: the housing body 50 of accommodating indicator 49; Lid 51 forms on housing body 50 and can freely load and unload; The O-ring seals of seal casinghousing main body 50 and lid 51 airtightly roughly; And the connecting portion 52,53 that is used to be communicated with the inside of housing body 50 and first pipeline 38, second pipeline 39.Connecting portion 52,53 is fixed on the housing body 50 in gastight mode roughly.
Lid 51 forms on the peristome that forms on the housing body 50 and can freely load and unload.Specifically, the part that is connected with inner shell main body 50 at lid 51 is formed with for example thread groove, combines with the ridge screw thread that forms on the counterpart of housing body 50 by thread groove, and lid 51 is installed on the housing body 50.In addition, as mentioned below, lid 51 also have be arranged on housing body 50 on the face that closely contacts of O-ring seals.
Then, housing body 50 is described.Fig. 8 is the sketch map of the outward appearance of expression housing body 50.As shown in Figure 8, housing body 50 forms except being used to lid 51 is installed the part of ridge, also has to be used for O-ring seals that seals in gastight mode roughly and the retaining part that forms flat indicator 49.In addition, form ridge near, be formed with narrow slit 50a, indicator 49 can be inserted in the space in the housing body 50 by narrow slit 50a, or therefrom pulls out.
Then, maintaining part 34 is described.Maintaining part 34 is to be used for inner shell 33 is stably remained on parts in the shell 26, and as shown in Figure 4, it is fixed on the inner surface of the case 30 that constitutes shell 26, and has the function that keeps inner shell 33.
Fig. 9 is the sketch map of the structure of expression maintaining part 34.As shown in Figure 9, maintaining part 34 has such structure, that is, at the upper and lower that forms columnar maintaining part main body 34a, integrally formed fin 34b, 34c.On fin 34b,, on maintaining part main body 34a, fin 34b, 34c, be formed with suitable blow vent 34e respectively except being formed for inserting the housing insertion section 34d of inner shell 33.In addition, shown in the profile of the maintaining part 34 of Fig. 4, on the inner surface of housing insertion section 34d, be formed with and be used for localized protuberance.
The internal diameter that fin 34b, 34c form the size of external diameter and case 30 about equally.By means of this structure, maintaining part 34 seamlessly is configured in the case 30.In addition, maintaining part 34 is adhesively fixed in the case 30.
Housing insertion section 34d forms and constitutes the corresponding narrow slit shape of plate portion of the housing body 50 of inner shell 33, inserts among the housing insertion section 34d and is adhesively fixed by means of plate portion, and inner shell 33 is maintained in the maintaining part 34.This hold mode helps importing and taking out indicator 49.That is, as mentioned above, the lid 51 that constitutes inner shell 33 has by screw thread in conjunction with the structure that can load and unload with respect to housing body 50.Therefore, in cargo handling process, lid 51 will be applied to circumferential power on the housing body 50, but, because housing body 50 is to be fixed under insertion forms state among the housing insertion section 34d of narrow slit shape, thereby can prevent that housing body 50 from rotating because of this circumferential power, that is, can prevent that both from rotating together.Particularly, in present embodiment 2, because first pipeline 38, second pipeline 39 be connected on the housing body by connecting portion 52,53, thereby, rotate together by preventing, just can avoid the damage of first pipeline, 38 grades.
In addition, blow vent 34e is used for preventing when being configured in maintaining part 34 in the case 30, forms the opening of confined space in case 30.For example, form cylindrical shape owing to constitute the maintaining part main body 34a of maintaining part 34, so inside just exists the gap.Formed in this gap under the situation of confined space, promptly use check valve 28 to carry out exhaust work, air in the confined space can not be discharged, the result, can not allow pressure state homogenization in the test assembly, therefore in order to keep good connected state, on each position, form blow vent 34e with other area of space.
In addition, the height of maintaining part 34, and inner shell 33 is inserted insertion amount in the housing insertion section 34d etc. can determine arbitrarily.But, in present embodiment 2, as ideal example, pre-determine the height of maintaining part 34 and inner shell 33 is inserted insertion amount among the housing insertion section 34d etc., make the upper end of lid 51, be positioned on the position than the more close top of opening portion of case 30 as the structural element that remains on the inner shell 33 on the maintaining part 34.In addition, if at the inner face of housing insertion section 34d the location protuberance is set, assembling just is easy to.
Figure 10 represents a sketch map of the state that the loam cake 31 that constitutes shell 26 disassembles from case 30.As shown in figure 10, in present embodiment 2, the structure of maintaining part 34 and inner shell 33 is to determine like this, promptly, when loam cake 31 is disassembled, be housed in the case 30, as the upper end of the lid 51 of the structural element of inner shell 33 in the state that protrudes than the more close top of the opening portion of case 30.Adopt this structure, after sterilization processing finished, being housed in indicator 49 in the inner shell 33 when taking out, user can be held lid 51 at an easy rate, thereby can disassemble lid 51 at an easy rate.More than, the structure of embodiment 2 has been described, each several part fits together mutually roughly to keep gastight state, has only the loam cake 31 of shell 26 and the lid 51 of inner shell 33 to load and unload with respect to case 30 and housing body 50.
Then, the using method of the sterilizing pretest pack for endoscope of simple declaration present embodiment 2.The sterilizing pretest pack for endoscope of present embodiment 2, need in advance portion within it be provided for confirming as the chemistry of the bactericidal effect of the sterilizing unit of object or biology indicator 49.At first, threads turn loam cake 31 is unloaded it down from case 30, and then, the lid 52 of threads turn inner shell 33 is unloaded it down again.So the narrow slit 50a of inner shell reveals, indicator 49 is inserted among the narrow slit 50a.After inserting indicator 49 in the inner shell 33, lid 51 is installed on the housing body 50, loam cake 31 is installed on the case 30.At this moment, each housing and lid all remain on roughly under the airtight conditions, and each lid is become flexible because of the pressure of sterilizing unit changes by screw threads for fastening Cheng Buhui.Then, sterilizing pretest pack for endoscope and as being placed into together by the endoscope of germicide in the sterilizer of regulation, with endoscope same condition under, accept sterilization processing.Then, in the evacuation operation of carrying out as the preceding operation that imports sterilization gas, effect by means of above-mentioned check valve 28, make the inner space of shell 26 and the inner space of pipeline resettlement section 27, in particular, make inner shell 33 around and the atmosphere that becomes on every side vacuum of first pipeline 38 and second pipeline 39.Check valve 28 has according to pressure condition makes the inner space of shell 26 and the structure of external communications.Because the inner space of pipeline resettlement section 27 has the structure that the inner space by connecting portion 29 is communicated with the inner space of shell 26, so as mentioned above, the inside of sterilizing pretest pack for endoscope just becomes uniform substantial vacuum state.
Then, import sterilization gas.Sterilization gas flows in first pipeline 38, second pipeline 39 by gas introduction port 40a, 41a, through after these two pipelines, arrives inner shell 33.Owing to keeping indicator 49 in inner shell 33, the sterilization gas after arriving will act on indicator 49.In addition, in this operation, because check valve 28 has separated the inner space of space outerpace and shell 26,, make the atmosphere of above-mentioned inner space maintenance substantial vacuum so sterilization gas can not flow in the inner space of the inner space of shell 26 and pipeline resettlement section 27.
After this, the sterilizing pretest pack for endoscope of present embodiment 2 with as by the endoscope of germicide, is taken out from sterilizer, carry out the affirmation of bactericidal effect.That is, respectively the lid 51 of loam cake 31 that constitutes shell 26 and formation inner shell 33 is disassembled, take out the indicator 49 that is housed in the inner shell 33.Then, by confirming the sterilization situation of indicator 49, just can judge whether as having been carried out sufficient sterilization by the endoscope of germicide.In addition, the same with the affirmation of indicator 49, also will check the leakage whether sterilization gas is arranged in the gas detection section 35, and sterilization gas invades unexpectedly, and also will confirm when importing sterilization gas, wait the atmosphere that whether keeps substantial vacuum around the inner shell 33.
The advantage of present embodiment 2 then, is described.At first, the same with the situation of embodiment 1, because the sterilizing pretest pack for endoscope of present embodiment 2 is put into sterilizer with endoscope and is carried out sterilization processing, so needn't directly verify, just can judge whether endoscope sterilizes fully to endoscope inside.Promptly, the sterilizing pretest pack for endoscope of present embodiment 2, owing to have through first pipeline 38 and second pipeline 39 sterilization gas imported structure in the inner shell 33, and pipeline 38,39 have with as the same structure of formed pipeline on by the endoscope of germicide, so, sterilization gas arrives the condition of inner shell 33, and is basic identical with the condition that arrives the pipeline mid point that endoscope had.Therefore, with the roughly the same condition of the condition of the pipeline mid point that arrives endoscope under, sterilization gas arrives the indicator 49 that is configured in the inner shell 33, by confirming the reaction condition of indicator 49, just can judge correctly that endoscope (in particular, be the most difficult part that sterilizes, the i.e. mid point of ducts of endoscope) sterilization situation.
In addition, the same with the situation of embodiment 1, the structure of present embodiment 2 is when importing sterilization gas, by means of the effect of check valve 28, to make the atmosphere that keeps substantial vacuum on every side of inner shell 33.Like this, be housed in the temperature of the indicator 49 in the inner shell 33, just only change according to the sterilization gas that is imported through first pipeline 38 and second pipeline 39, thus can more correctly realize with the sterilization environment facies of the pipeline that in endoscope, forms with, perhaps stricter sterilization environment.
General sterilization processing is to be undertaken by being exposed in the sterilization gas atmosphere under the hot conditions of regulation, in order fully to carry out sterilization processing, and must be the temperature that is heated to regulation by germicide.Therefore, in the coefficient of overall heat transmission that is delivered to inner shell 33 from space outerpace, than being delivered to from space outerpace as by under the taller situation of the coefficient of overall heat transmission of the ducts of endoscope mid point of germicide, the indicator 49 that is configured in inner shell 33 inside just is in than in the also weak sterilization environment of pipeline mid point, might reduce the judgement precision to the sterilization conditions of endoscope.Particularly, because inner shell 33 will be accommodated indicator 49, so have to adopt the structure with surface area bigger than the pipeline of endoscope, under residual the situation of heat transfer substances such as gas, the probability that the coefficient of overall heat transmission is higher than the pipeline of endoscope is very big around inner shell 33.
For this reason, the same with embodiment 1, present embodiment 2 has adopted when importing sterilization gas, allows inner shell 33 keep the structure of substantial vacuum atmosphere on every side.As everyone knows, because the atmosphere of substantial vacuum has shown very superior heat-insulating property, so, from space outerpace directly (promptly, be not by means of the sterilization gas that has passed through first pipeline 38 and second pipeline 39) transmit the heat of coming in, almost can ignore.Therefore, the sterilizing pretest pack for endoscope of present embodiment 2 from the viewpoint of the coefficient of overall heat transmission, has the advantage that can realize the sterilization environment roughly the same or strict more with pipeline that endoscope has.
Also have, the sterilizing pretest pack for endoscope of present embodiment 2 has a plurality of pipelines is housed in structure in the independent pipeline resettlement section 27.Therefore, the sterilizing pretest pack for endoscope of present embodiment 2 also can be realized such as shown in Figure 3 simple surface structure, for the user, has easy to operate advantage.
In addition, in present embodiment 2, the structure of employing is, is housed in the independent pipeline resettlement section 27 corresponding to first pipeline 38 and second pipeline 39, when importing sterilization gas, keeps the substantial vacuum atmosphere around making first pipeline 38 and second pipeline 39.At this moment, when each pipeline is near each other,, might influence each other at heating surface.
For this reason, in present embodiment 2, adopted such structure: when importing sterilization gas, make first pipeline 38 and second pipeline, 39 both sides' the atmosphere that keeps substantial vacuum on every side, thereby prevent that generation is heat passage between first pipeline 38 and second pipeline 39 etc., make and can not transmit heat mutually between the pipeline.By adopting such structure, can make the sterilization environment in the sterilizing pretest pack for endoscope also stricter, thereby have the higher advantage of the degree of reliability that the sterilization situation is judged than the sterilization environment of endoscope.
Also have, the sterilizing pretest pack for endoscope in the present embodiment 2 has such structure: have the gas detection section 35 that is used to detect sterilization gas inflow shell 26 inner spaces.Can understand from above explanation, dispose the inside of the shell 26 of inner shell 33, when importing sterilization gas, need to keep the atmosphere of substantial vacuum.; for example under situation such as the air-tightness of shell 26 is not enough; in the operation of evacuation; effect by means of check valve 28; make the inside of shell 26 become the atmosphere of substantial vacuum; when importing sterilization gas, make the inner space of sterilization gas inflow shell 26 then, might destroy the atmosphere of substantial vacuum.Under the ruined situation of the atmosphere of substantial vacuum, owing to can not expect above-mentioned insulation effect again, thereby judge that by means of sterilizing pretest pack for endoscope the degree of reliability of the sterilization situation of endoscope has just reduced.Therefore, in present embodiment 2, in order to confirm whether have this sterilization gas to flow into and disposed gas detection section 35, under the situation of the inner space of having confirmed sterilization gas inflow shell 26 by gas detection section 35, utilize another test assembly to carry out countermeasures such as endoscope's sterilization processing once more.As a result, owing to the long-time situations such as producing deterioration of using, just in case under the situation about having problems on the structure of shell 26 etc., present embodiment 2 also has the advantage that can detect this unfavorable condition rapidly.
(variation 1)
Below, the variation 1 of embodiment 2 is described.The sterilizing pretest pack for endoscope of this variation 1, also has following mechanism, when importing sterilization gas, this mechanism can detect the inner space of shell 26 and pipeline resettlement section 27 (in other words, i.e. inner shell 33, first pipe, 38 and second pipeline 39 around) and whether keep the substantial vacuum atmosphere.
Figure 11 is the sketch map of this mechanism of expression and peripheral structure thereof.As shown in figure 11, on case 55 as the shell mechanism key element, except with the coupling part of loam cake 31, also formed the through hole that is communicated with space outerpace.Sterilizing pretest pack for endoscope in this variation 1 has following structure,, by the flexible thin 56 that is adhesively fixed in gastight mode roughly, covers this through hole that is.
Flexible thin 56 is as vacuum detecting portion, and its effect is to detect the atmosphere that whether has kept substantial vacuum in the case 55.Specifically, flexible thin 56 is to make by having bubble-tight softish lamellar parts, it blocks gas flow between the inner space of space outerpace and case 55 on the one hand, on the other hand, also have according to the magnitude relationship between the pressure of the inner space of the pressure of space outerpace and case 55 and the character of easy deformation.Flexible thin 56 utilizes this character, and whether the inner space that just can detect case 55 has kept the atmosphere of substantial vacuum.
Figure 12 is illustrated in after sterilization processing finishes, the sketch map of the state that the sterilizing pretest pack for endoscope of this variation 1 is taken out from sterilizer.Under the situation that each element of sterilizing pretest pack for endoscope works orderly, effect by means of above-mentioned check valve 28, make the inner space of case 55 keep the atmosphere of substantial vacuum, only otherwise disassemble, just can keep the atmosphere of this substantial vacuum with the case 55 common loam cakes 31 that constitute shells.Therefore, when sterilizing pretest pack for endoscope is taken out, be placed on condition of normal pressure following time from sterilizer, the pressure of space outerpace is just than the pressure height of case 55 inner spaces, so, seem that from space outerpace flexible thin 56 just is deformed into recessed shape along with this pressure differential.Therefore, user can judge whether to have kept the substantial vacuum atmosphere at an easy rate according to the affirmation to flexible thin 56 shapes, has the advantage that can judge whether sterilizing pretest pack for endoscope has been carried out suitable sterilization processing operation at an easy rate.
(variation 2)
The variation 2 of embodiment 2 then, is described.The sterilizing pretest pack for endoscope of this variation 2 also has the structure that pipeline resettlement section 27 is held in spiral helicine keeper.Figure 13 is the sketch map of outward appearance of the sterilizing pretest pack for endoscope of expression this variation 2.As shown in figure 13, in this variation 2, also have the face shaping of pipeline resettlement section 27 is held in spiral helicine keeper 58.
Figure 14 is the sketch map of the structure of expression keeper 58.As shown in figure 14, keeper 58 has by a plurality of breakthrough part 58a and the integrally formed structure of connecting portion 58b, and a plurality of breakthrough part 58a are formed with and are used to pipeline 58c that pipeline resettlement section 27 is passed, and connecting portion 58b is used for the connection between the adjacent breakthrough part 58a.By pipeline resettlement section 27 is remained on the state that passes pipeline 58c on the keeper 58 of this structure, as shown in figure 13, just can be held in spiral status to pipeline resettlement section 27.By pipeline resettlement section 27 is held in state shown in Figure 13, just can reduce sterilizing pretest pack for endoscope occupied zone in sterilizer inside etc.In addition, compare, also have advantages such as easy to use with the structure that equal length is extended in pipeline resettlement section 27.
(variation 3)
The variation 3 of embodiment 2 then, is described.The same with variation 2, the sterilizing pretest pack for endoscope of this variation 3 has pipeline resettlement section 27 is held in spiral helicine keeper.Figure 15 is the integrally-built sketch map of this keeper of expression.Promptly, as shown in figure 15, employed keeper in this variation 3 is by wearing via portion to pipeline resettlement section 27, pipeline resettlement section 27 is held in spiral status, and above-mentioned hole portion is configured on the maintaining part 61 that is formed between top annular element 59 and the below annular element 60.
Figure 16 is the sketch map of the structure of expression maintaining part 61.As shown in figure 16, maintaining part 61 is made and is had parts of accommodating 62 and push part 63.The structure of accommodating parts 62 is such: two ends are separately fixed on top annular element 59 and the below annular element 60, are spaced into U font structure with regulation between two ends.Push part 63 is formed by bar-like member, and an end of this bar-like member is fixed on the annular element 59 of top with the state that can freely rotate, the other end then form can below loading and unloading on the annular element 60.
In this variation 3, be to keep pipeline resettlement section 27 like this, at first, push part 63 from below the state that disassembles of annular element 60 (promptly, state shown in Figure 16) under, pipeline resettlement section 27 suitably is configured in spiral accommodating forms on the parts 62 in the U font structure.Then, by the other end of push part 63 being fixed on the annular element 60 of below, the open side of closed U font structure prevents that pipeline resettlement section 27 from splitting away off from U font structure.Like this, just formed the state that keeps pipeline resettlement section 27, the same with the situation of variation 2, can be held in spiral status to pipeline resettlement section 27.
Embodiment 3
Below, embodiment 3 is described.The sterilizing pretest pack for endoscope of present embodiment 3, the structure of employing is: pipeline is remained in the closed shell of regulation, when importing sterilization gas, make this enclosure interior keep the atmosphere of substantial vacuum.
Figure 17 is the sketch map of outward appearance of the sterilizing pretest pack for endoscope of expression present embodiment 3.As shown in figure 17, the sterilizing pretest pack for endoscope of present embodiment 3 has following part: the housing 65 of accommodating pipeline; Be used to make the inner space of housing 65 to become the check valve 66 of substantial vacuum atmosphere; Lid 67, inner shell has been accommodated in inside, with housing 65, plays a role as an example of the housing material in the claim; Be the gas introduction part 68 that the sterilization gas import pipe is used; And whether the inner space that is used to detect housing 65 keeps the flexible thin 69 of substantial vacuum atmosphere.
Figure 18 is the sketch map of structure of the sterilizing pretest pack for endoscope of expression present embodiment 3.As shown in figure 18, pipeline 70 is configured in the inside of housing 65, and in the outside of housing 65, promptly in the zone that in use tegmentum 67 and space outerpace cut off, has disposed inner shell 71, and is used for pipeline 70 and inner shell 71 are communicated with the connecting portion 72 of getting up.Owing to have above structure, the sterilizing pretest pack for endoscope of present embodiment 3 imports in the inner shell 71 by pipeline 70 from the sterilization gas of space outerpace by 68 inputs of gas introduction part.
Then, describe in detail cover 67, the structure of inner shell 71 and connecting portion 72.Figure 19 is that expression covers 67, the sketch map of the structure of inner shell 71 and connecting portion 72.Lid 67 is to be used for inner shell 71 and space outerpace are separated next parts, and have such function: the evacuation operation by sterilization processing and import these two operations of operation of sterilization gas, around the inner shell 71 with respect to space outerpace with roughly airtight conditions blocking-up.Specifically, lid 67 has such structure: form peristome in a side that is connected with connecting portion 72, near this peristome, also be formed for and the bonded thread groove of connecting portion 72 screw threads simultaneously, with part that housing 65 contacts on, then disposed seal member 67a.
Seal member 67a is the parts with easy deformation, for example, forms with elastomeric element, and forms the ring-type of covering 67 peristome periphery.By with part that housing 65 contacts on configuration seal member 67a, when lid 67 screw threads are combined on the connecting portion 72, lid 67 just can be fixed on the housing 65 in gastight mode roughly, thereby can be the inner space of lid 67, and promptly inner shell 71 blocks with space outerpace on every side.
Inner shell 71 is for keeping being used for confirming the parts of the indicator 73 of bactericidal effect.Inner shell 71 has such structure: there is the area of space that keeps indicator 73 in portion within it, and has formed the thread groove that combines usefulness with connecting portion 72 screw threads, screw thread in conjunction with the time with part that connecting portion 72 contacts on disposed seal member 71a.Because seal member 71a arranged, therefore when inner shell 71 screw threads are combined on the connecting portion 72, contact site contacts with connecting portion 72 in gastight mode roughly.In addition, housing 65 (with connecting portion 72) and the air tight manner that covers 67, and the air tight manner of connecting portion 72 and inner shell 71, it also can be such air tight manner, that is, the O-ring seals of elastomeric element for example is set, in the bonded process of screw thread on the gastight part of needs, make the O-ring seals distortion, so that each parts closely contact.
Figure 20 is the sketch map of the outward appearance of expression inner shell 71.As shown in figure 20, the same with inner shell 33 among the embodiment 2, inner shell 71 is formed with the narrow slit 71b that is used to put into or take out indicator 73 near the zone that forms thread groove, and the part of holding laminar indicator 73 forms tabular.
Connecting portion 72 has following function: the function of the inner space of connecting pipe 70 and inner shell 71, and around the inner shell 71, the i.e. function that the inner space of lid 67 is communicated with the inner space of housing 65.Specifically, as shown in figure 19, be formed with on the connecting portion 72 to connect and use protruding 72a, this connection is the shape that can insert in pipeline 70 ends with protruding 72a.In addition, the connection of connecting portion 72 is inserted and secured on the end of pipeline 70 in gastight mode roughly with protruding 72a.Pipeline 70 also can be fixed in gastight mode roughly with bonding agent with being connected with protruding 72a.And be formed with when inner shell 71 screw threads are combined on the connecting portion 72, the through hole 72d of the inner space of the inside of connecting pipe 70 and inner shell 71, with at lid 67 screw threads when being combined on the connecting portion 72, be communicated with the through hole 72e of the inner space of covering 67 inner space and housing 65.Because above structure has been arranged, connecting portion 72 has following function: importing inner shell 71 by the sterilization gas behind the pipeline 70, and as mentioned below, the pressure that covers 67 inner spaces is maintained the same value of pressure with housing 65 inner spaces.
Then, gas introduction part 68 is described.Figure 21 is the sketch map of the structure of expression gas introduction part 68.As shown in figure 21, the structure of gas introduction part 68 is as follows: be formed with to connect and use protruding 68a, this connection has the shape in the end (end of the opposition side of the side that is connected with connecting portion 72) that can insert pipeline 70 with protruding 68a; And be formed with through hole 68b, under the state in connecting the end of inserting pipeline 70 with protruding 68a, be used for connecting pipe 70 and space outerpace.Pipeline 70 is fixed together in gastight mode roughly with being connected with protruding 68a.In addition, also can be fixed together in gastight mode roughly between the two with bonding agent.By means of the through hole 68b that forms, pipeline 70 is communicated with space outerpace, when importing sterilization gas, just can suck sterilization gas the inner shell 71 from space outerpace.In addition, the diameter of the through hole 68b that on gas introduction part 68, forms, preferably and the internal diameter of pipeline 70 about equally.In addition, self-evident, the pipeline structure of the pipeline structure simulated endoscope inside of pipeline 70 constitutes.The contact of and pipeline 70 inner about housing 65 if the rising of pipeline 70 temperature and the bactericidal effects such as trafficability characteristic of the sterilization gas in the pipeline 70 are not exerted an influence, then can be any in contact or the noncontact.
Then, flexible thin 69 is described.The same with the flexible thin 56 among the embodiment 2, flexible thin 69 is to be used to detect the parts whether housing 65 inner spaces keep the substantial vacuum atmosphere.Figure 22 is the sketch map of the structure of expression flexible thin 69.As shown in figure 22, formed the peristome (in the present embodiment, on the lid 65b shown in Figure 17) of regulation on housing 65, flexible thin 69 is fixed on the shell 65 in gastight mode roughly under the state that covers this opening.Flexible thin 69 is by softness and has bubble-tight lamellar parts to make that it has the characteristic that changes its shape along with the magnitude relationship between the inner space pressure of space outerpace pressure and housing 65.
Figure 23 is the sketch map of the state of the flexible thin 69 of expression when from sterilizer the sterilizing pretest pack for endoscope of embodiment 3 being taken out.Sterilizing pretest pack for endoscope in the present embodiment 3 is designed to, and is evacuated by the chamber interior sterilizer, makes the inner space (with lid 67 inner space) of housing 65 be changed to and roughly is vacuum.Like this, when the function sterilizing pretest pack for endoscope performance as the design, the pressure that is in the space outerpace under the normal pressure is just than the pressure height of the inner space of the housing 65 of maintenance substantial vacuum atmosphere, so as shown in figure 23, from the outside, the shape of flexible thin 69 becomes recessed shape.Like this, user is confirmed the shape of flexible thin 69 by range estimation, and whether the inner space that just can judge housing 65 at an easy rate keeps the atmosphere of substantial vacuum.Check valve 66 has the structure same with the check valve 28 of embodiment 2, is fastened on the housing 65 in gastight mode roughly.In addition, above-mentioned housing 65 is to be made of housing body 65a and lid 65b, be connected and fixed in gastight mode roughly mutually, self-evident, with can deformed configurations, raw material (metal material, resin material) making because the sterilizer internal pressure changes.
The effect of the sterilizing pretest pack for endoscope of present embodiment 3 then, is described with reference to Figure 24.The same with embodiment 1,2, the sterilizing pretest pack for endoscope of present embodiment 3 is put into sterilizer with endoscope, after the chamber interior of sterilizer is pumped into vacuum, imports sterilization gas.When carrying out this evacuation operation, present embodiment 3 with becoming the atmosphere of substantial vacuum around pipeline 70 and the inner shell 71, in the process of the importing sterilization gas that then carries out, still keeps the atmosphere of this substantial vacuum by means of the effect of check valve 66.Promptly, the same with the check valve 28 among the embodiment 2, check valve 66 only has in housing 65 pressure inside and is higher than the structure that the situation lower valve of the pressure of space outerpace is just opened, so, in the evacuation operation, when the pressure of space outerpace reduces, the gas that remains in housing 65 inner spaces just is discharged in the space outerpace, thereby the inner space just becomes the atmosphere of substantial vacuum, in other words, has become the atmosphere of substantial vacuum around the pipeline 70.
In addition, such as already explained, the structure of connecting portion 72 is such: have and be used for a through hole 72e that lid 67 inner space is communicated with the inner space of housing 65.Therefore, under lid 67 states that are connected on the connecting portion 72, the pressure that covers 67 inner spaces just keeps the identical value of pressure with housing 65 inner spaces, effect by means of above-mentioned check valve 66, the inner space of housing 65 becomes the atmosphere of substantial vacuum, thus the atmosphere that has also just become substantial vacuum on every side of inner shell 71.From above explanation as can be known, the same when adopting the mode the same to import sterilization gas with the situation of embodiment 2 with the situation of embodiment 2, the atmosphere that has kept substantial vacuum on every side of pipeline 70 and inner shell 71.
The advantage of the sterilizing pretest pack for endoscope of present embodiment 3 then, is described.At first, the sterilizing pretest pack for endoscope of present embodiment 3, since the same with embodiment 1,2, pipeline used, so can judge that conduct is by the sterilization situation of the endoscope of germicide with the pipeline same structure that is possessed with endoscope.
Also have, the sterilizing pretest pack for endoscope of present embodiment 3, it is simple to have a surface structure, and advantage such as easy to operate.That is, as shown in figure 17, the outward appearance of the sterilizing pretest pack for endoscope in the present embodiment 3 has the shape of chest, has the easier advantage of putting into sterilizer or therefrom taking out.In addition, even have under the situation of this surface structure, can not reduce conduct by the reliability of the judgement of the sterilization situation of the endoscope of germicide yet.Promptly, as explanation in embodiment 2, under the state of the atmosphere that keeps substantial vacuum around inner shell 71 and the pipeline 70, when importing sterilization gas, owing to can not consider heat passage by housing 65 and lid 67, so just can adopt arbitrarily the specifically parts of shape.
In addition, in present embodiment 3, as shown in figure 25, can also be this structure: for an independent housing 65, be provided with some to cover 67, gas introduction part 68, pipeline 70, inner shell 71 and connecting portion 72.Under the situation of this structure, only have with an independent sterilizing pretest pack for endoscope, just the advantage that can judge the sterilization situation of some kinds of endoscopies.In addition, in present embodiment 3, sterilization gas is imported in the inner shell 71 by an independent pipeline 70, but, be not to be confined to this structure, also can be the same with embodiment 2 grades, by some pipelines sterilization gas is imported in the inner shell 41.In addition, in embodiment 3, in order to confirm whether housing 65 inside keep the atmosphere of substantial vacuum, on the part of housing 65, be provided with flexible thin 69, but, if the structure of the gas detection section 35 being provided with shown in embodiment 2 in lid 67 just can confirm whether sterilization gas has entered inside (promptly, the atmosphere that whether has kept substantial vacuum), thus can omit flexible thin 69.
Embodiment 4
The sterilizing pretest pack for endoscope of embodiment 4 then, is described.The sterilizing pretest pack for endoscope of present embodiment 4 has such structure, that is, the shell of accommodating pipeline forms the energy freely openable, when shell is in open mode, just can change pipeline and inner shell.
Figure 26 is the sketch map of outward appearance of the sterilizing pretest pack for endoscope of expression present embodiment 4.As shown in figure 26, the sterilizing pretest pack for endoscope of present embodiment 4 has following part: housing 74 is made of lower house 75 that can contact with each other or leave and upper shell 76; Hasp 77 to be fixed on the state configuration on the lower house 75, when housing 74 is in closed condition, plays the effect of pushing upper shell 76; Gas introduction part 78 is configured to embed respectively the state of the recess that forms on lower house 75 and upper shell 76, have be configured in housing 74 in the gas introduction port 78e that is communicated with of pipeline 80 (representing among Figure 26); And check valve 79, be used to make the inner space of housing 74 to become the atmosphere of substantial vacuum.
Figure 27 is the sketch map of outward appearance that expression housing 74 is in the sterilizing pretest pack for endoscope of open mode.As shown in figure 27, in the internal configurations of lower house 75 pipeline 80 and the inner shell 81 that is communicated with gas introduction part 78, on the inner surface of upper shell 78, disposed and detected the gas detection section 83 that whether has sterilization gas to leak.In addition, on lower house 75 and upper shell 76 these two parts, the recess 75a, the 76a that are used to make 78 embeddings of gas introduction part have been formed respectively, and, when housing 74 is in closed condition, on the contact surface of the lower house 75 that contacts with upper shell 76, disposed seal member 82, so that the part that lower house 75 contacts with upper shell 76 is in roughly airtight conditions.
Then, gas introduction part 78, pipeline 80 and inner shell 81 are described.Figure 28 is the sketch map of expression gas introduction part 78, pipeline 80 and inner shell 81 annexation each other.As shown in figure 28, on gas introduction part 78, connecting pipeline 80 and inner shell 81 successively, sterilization gas by the gas introduction port 78e that forms on gas introduction part 78 imports from space outerpace by after the pipeline 80, arrives the indicator that is configured in the inner shell 81.In addition, inner shell 81 is by constituting with the lower part: can remain on its inner main part to indicator; With connecting portion 81a, can load and unload with respect to main part, when installing, be fixed on the main part in gastight mode roughly.In addition, the structure of the inner shell 71 among the structure of main part and the embodiment 3 is identical.Connecting portion 81a is fixed on the pipeline 80 in gastight mode roughly, has the through hole with the internal communication of the inside of main part and pipeline 80.The concrete structure of connecting portion 81a, for example, can be identical with connecting portion described later 92,93.
Figure 29 is the sketch map of the structure of expression gas introduction part 78.As shown in figure 29, gas introduction part 78 has following part: the corresponding main body 78a of shape with side view and recess 75a, 76a; And make from disc-shaped part 78b, the 78c of above-below direction clamping main body 78a.On disc-shaped part 78b, formed to connect and used protruding 78d, connected and to insert in the pipeline 80, and had the shape that when inserting, can be fixed in the pipeline 80 with air tight manner with protruding 78d.Above-mentioned gas introducing port 78e is communicated with the front end that is connected with protruding 78d by the through hole that runs through main body 78a, disc-shaped part 78b, 78c, by means of this structure, and just can be in the sterilization gas import pipe 80 of space outerpace.In addition, on the periphery of main body 78a, disposed the O-ring seals 78f that makes with elastomeric material in the mode of tight crimping.
Main body 78a has and can embed structure among recess 75a, the 76a in gastight mode roughly.Specifically, for example when housing 74 is in closed condition, form through hole by recess 75a, 76a, the external diameter of main body 78a is more a little bit smaller a little than the internal diameter of this through hole, and can pass the internal diameter of this through hole, thereby remain on the state in the internal diameter that is clamped in recess 75a, the formed through hole of 76a.At this moment, be configured in the O-ring seals 78f on the side face of main body 78a, have the external diameter bigger than the through hole that forms by recess 75a, 76a, because O-ring seals 78f makes with elastomeric material, therefore produce distortion, and closely contact with the whole peripheral surface of the through hole internal diameter that forms by recess 75a, 76a.By means of this structure, when configuration gas introduction part 78, just can not produce the gap between main body 78a and recess 75a, the 76a, can be with gastight mode stationary body 78a roughly.In addition, main body 78a can all make with elastomeric material, but in this case, must be designed to the external diameter of main body 78a only (to adopt this structure, can omit O-ring seals 78f) a little more greatly than the internal diameter of recess 75a, the formed through hole of 76a.Better is, main body 78a is to make with elastomeric material near having only the part that contacts with recess 75a, 76a, and the gas introduction port 78e that connects makes with hard material.Under the situation that adopts this structure, main body 78a has only near the generation of periphery to be out of shape, on the central part that forms through hole in the process that embeds recess 75a, 76a, still keep original shape, thereby can be suppressed at the variation of the shape of through holes that forms on the middle body.In addition, also can adopt the major part of main body 78a is elastomeric element, and the structure that the peripheral part of through hole is strengthened with metal parts.
Then, gas detection section 83 is described.Figure 30 is the sketch map of the structure of expression gas detection section 83.The same with the gas detection section 35 among the embodiment 2, gas detection section 83 is to be used for detecting the parts whether sterilization gas has entered the inner space of housing 74.Specifically, gas detection section 83 is to be made of resettlement section on the inner surface that is configured in upper shell 76 85 and the indicator 86 that is housed in the resettlement section 85.The structure of check valve 79 is identical with the structure of the check valve 28 of embodiment 2.
The advantage of the sterilizing pretest pack for endoscope of present embodiment 4 then, is described.The advantage of the sterilizing pretest pack for endoscope of present embodiment 4 is identical with embodiment 3, particularly, in the judgement to the sterilization situation, keeps the reliability of height, and has the structure that can open and close housing 74, thereby also have the advantage of the maintenance of being easy to.That is, under the situation that certain fault takes place, under the state of opening housing 74, can check being housed in inner pipeline 80 grades at an easy rate, it seems just have easy to operate advantage from this viewpoint.
In addition, the sterilizing pretest pack for endoscope of present embodiment 4 also has broad-spectrum advantage.Specifically, in present embodiment 4, because housing 74 has the structure that can open and close, therefore, for example carry out under the situation of sterilization processing, just can prepare to be applicable to the pipeline of new endoscopic easily, used in the past pipeline is more changed in endoscope to structure different from the past.Therefore, the sterilizing pretest pack for endoscope of present embodiment 4, the endoscope that can tackle various structure it seems from this viewpoint, has just produced scope of application advantage widely.
(variation)
The variation of embodiment 4 then, is described.The structure of the sterilizing pretest pack for endoscope of this variation is that the sterilizing pretest pack for endoscope of embodiment 4 is constituted, and is the same with embodiment 1,2, by two pipelines sterilization gas imported in the inner shell.In addition, in this variation, the structures different with embodiment 4 are gas introduction part, pipeline and inner shell, in addition, all continue to use the parts identical with embodiment 4.
Figure 31 is the sketch map of the outward appearance of gas introduction part 88, first pipeline 89, second pipeline 90 and inner shell 91 in this variation of expression.As shown in figure 31, gas introduction part 88 has such structure: on the one hand, the same with the gas introduction part 78 among the embodiment 4, have main body 88a and disc-shaped part 88b, 88c, formed respectively with first pipeline 89, second pipeline, 90 corresponding a plurality of gas introduction ports on the other hand, be connected with projection and be communicated with both through hole (all in Figure 31, not representing).In addition, in this variation, preferably the same with embodiment 1,2, first pipeline 89 and second pipeline 90 are made equal in length.Under the situation of equal in length, the occupied zone of inner shell 91 just with as corresponding by the pipeline mid point of the endoscope of germicide.That is, the structure of pipeline is identical with embodiment 1,2.
Figure 32 represents inner shell 91 and is used for first pipeline 89, second pipeline 90 are connected to the sketch map of the structure of the connecting portion 92,93 on the inner shell 91.Shown in figure 32, connecting portion 93,92 has such structure: its inside is in connected state with first pipeline 89, second pipeline 90 respectively on the one hand, and fixed thereon, has also formed on the other hand to be used for and the bonded ridge of inner shell 91 screw threads.91 of inner shells have formed and the corresponding thread groove of this ridge, and, with part that connecting portion 92,93 contacts on, disposed seal member 91b, 92b respectively, thus have screw thread in conjunction with the time, roughly be airtight conditions.By means of the parts that use this structure, the sterilizing pretest pack for endoscope among the embodiment 4 is just the same with embodiment 1,2, can realize by many pipelines the structure in the sterilization gas importing inner shell.
Figure 33 is the sketch map of the outward appearance of expression gas introduction part 88.Gas introduction part 88 disposes in the O-ring seals 88f on the side face of main body 88a, has also formed the gas introduction port 88g, the 88h that sterilization gas are imported first pipeline 89, second pipeline 90 respectively.
In addition, in this variation, what illustrate is by many pipelines sterilization gas to be imported structure in the independent inner shell, in addition, as shown in figure 34, also can be corresponding to some pipelines are set, several inner shells also are set, sterilization gas are imported in each inner shell by a pipeline.In this case, only just have, just can judge the advantage of the sterilization situation of multiple endoscope with an independent sterilizing pretest pack for endoscope.
In addition, as shown in figure 35, also can when being set, a plurality of recess 75a, 76a use many gas introduction parts 78 corresponding and pipeline 80 etc. with it.Under the situation that adopts this structure, just has the advantage that to judge the sterilization situation of multiple endoscope simultaneously.In addition, the structure of a plurality of recess 75a, 76a is set in employing, and gas introduction part 78 grades are only used under one the situation, for being not used in recess 75a, the 76a that embeds gas introduction part 78, can wait the airtight conditions of guaranteeing roughly by the packing ring that regulation is set.
[appendix]
According to as above-mentioned detailed of the present invention above-mentioned each embodiment, can obtain following various structures.
(1) a kind of sterilizing pretest pack for endoscope is characterized in that, has:
Inner shell has the switching mechanism that can allow the indicator of the bactericidal effect that is used to confirm that sterilization processing reaches freely come in and go out;
At least one pipeline is connected on the above-mentioned inner shell, and an end opening, the internal communication of the other end and above-mentioned inner shell; And
Accommodate the external packing component of above-mentioned pipeline and above-mentioned inner shell.
(2) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Above-mentioned external packing component is by constituting with the lower part: the shell of accommodating above-mentioned pipeline and above-mentioned inner shell; Can pass the flexible pipe of the part of above-mentioned pipeline with being communicated with this shell also.
(3) as appendix (1) or (2) described sterilizing pretest pack for endoscope, it is characterized in that,
One end of above-mentioned pipeline is to the outside opening of above-mentioned external packing component.
(4) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Space between the outside of above-mentioned pipeline and above-mentioned inner shell and the above-mentioned external packing component is roughly gastight.
(5) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Above-mentioned inner shell and pipeline constitute, and the condition of the above-mentioned sterilization processing in the pipeline of the endoscope that stipulates when carrying out above-mentioned sterilization processing, above-mentioned external packing component is identical, perhaps adapt to the sterilization processing condition of longer time.
(6) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Connecting two first, second pipelines on above-mentioned inner shell, these two first, second pipelines have roughly the same length.
(7) as the described sterilizing pretest pack for endoscope of appendix (6), it is characterized in that,
The diameter of above-mentioned first, second pipeline is roughly the same.
(8) as the described sterilizing pretest pack for endoscope of appendix (2), it is characterized in that,
Above-mentioned shell has following parts: housing body, and accommodate above-mentioned inner shell in gastight mode roughly, and can freely put into, take out above-mentioned inner shell; Flexible pipe is installed in this housing body in gastight mode roughly, and coats above-mentioned pipeline; And be arranged on end piece on the peristome of above-mentioned pipeline.
(9) as the described sterilizing pretest pack for endoscope of appendix (2), it is characterized in that,
Above-mentioned flexible pipe has in gastight mode roughly and is connected two first, second flexible pipes on the above-mentioned shell; Above-mentioned first flexible pipe is provided with front end component at its base end part, and this front end component has the peristome of above-mentioned pipeline; And above-mentioned second flexible pipe is provided with back-end component on its end, and this back-end component has the peristome of above-mentioned pipeline, and has check valve or gas vent.
(10) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Above-mentioned indicator is a chemical ind, perhaps biology indicator.
(11) as the described sterilizing pretest pack for endoscope of appendix (1), it is characterized in that,
Above-mentioned sterilization processing is the sterilization processing that becomes the air displacement in the sterilizer chamber other gas to carry out.
(12) as the described sterilizing pretest pack for endoscope of appendix (11), it is characterized in that,
Also have check valve, this check valve discharges above-mentioned inner shell on every side, and keep this state after air-out in the negative pressure operation of above-mentioned sterilizer with above-mentioned pipeline ambient air.
Sterilizing pretest pack for endoscope of the present invention, by means of structure and the suitable test assembly of endoscope that carries out sterilization processing are set, can obtain the roughly the same bactericidal effect of bactericidal effect with above-mentioned endoscope, and can simply and effectively carry out the affirmation of bactericidal effect, as long as corresponding to the type constitution of the endoscope that carries out sterilization processing, just can confirm the bactericidal effect of various endoscopies effectively.

Claims (10)

1. sterilizing pretest pack for endoscope is characterized in that having:
Inner shell has the switching mechanism that can allow the indicator of the bactericidal effect that is used to confirm that sterilization processing reaches freely come in and go out;
At least one pipeline is connected on the above-mentioned inner shell, and an end has the opening that is used to import sterilization gas, the other end and above-mentioned inner shell internal communication; And
External packing component is accommodated above-mentioned pipeline and above-mentioned inner shell.
2. sterilizing pretest pack for endoscope as claimed in claim 1 is characterized in that,
Above-mentioned external packing component has following part: the shell of accommodating the part of above-mentioned inner shell and above-mentioned pipeline; And the pipeline resettlement section that is communicated with and runs through the remainder of above-mentioned pipeline with this shell.
3. sterilizing pretest pack for endoscope as claimed in claim 2 is characterized in that,
Above-mentioned pipeline resettlement section forms, and from space outerpace the coefficient of overall heat transmission of the outer surface of the remainder of the above-mentioned pipeline of inleakage is equal to or less than from space outerpace in the coefficient of overall heat transmission as the inner pipeline that forms of endoscope of sterilization processing object.
4. sterilizing pretest pack for endoscope as claimed in claim 2 is characterized in that,
Above-mentioned shell forms, and when importing sterilization gas by above-mentioned pipeline, makes above-mentioned inner shell keep being roughly the atmosphere of vacuum on every side.
5. sterilizing pretest pack for endoscope as claimed in claim 2 is characterized in that,
Above-mentioned pipeline resettlement section has in gastight mode roughly and is connected first, second two flexible pipes on the above-mentioned shell; Above-mentioned first flexible pipe is provided with front end component on its base end part, have the peristome of above-mentioned pipeline on this front end component; And above-mentioned second flexible pipe is provided with back-end component on its end, has the peristome of above-mentioned pipeline on this back-end component, and has the blow vent of check valve or gas.
6. sterilizing pretest pack for endoscope as claimed in claim 2 is characterized in that,
Inner shell disposes two above-mentioned pipelines relatively, and above-mentioned pipeline resettlement section has the single flexible pipe that two above-mentioned pipelines are run through.
7. sterilizing pretest pack for endoscope as claimed in claim 2 is characterized in that,
Above-mentioned pipeline resettlement section is to be formed by the flexible pipe with flexible and free bend, and has the above-mentioned pipeline resettlement section of extending specific length to be organized into the keeper that spiral helicine state keeps.
8. sterilizing pretest pack for endoscope as claimed in claim 1 is characterized in that,
Above-mentioned external packing component forms, and when importing sterilization gas by above-mentioned pipeline, makes the atmosphere that keeps substantial vacuum on every side of above-mentioned inner shell and above-mentioned pipeline at least.
9. sterilizing pretest pack for endoscope as claimed in claim 4 is characterized in that,
Also has check valve, it utilized before importing sterilization gas by above-mentioned pipeline, the inside of having put into the sterilizer of this sterilizing pretest pack for endoscope is in the negative pressure state this point, discharges above-mentioned inner shell ambient air, and keeps the state of air-out when importing sterilization gas.
10. sterilizing pretest pack for endoscope as claimed in claim 1 is characterized in that,
One end of above-mentioned pipeline is to the outside opening of above-mentioned external packing component.
CNB2005800021365A 2004-01-08 2005-01-11 Sterilizing pretest pack for endoscope Expired - Fee Related CN100562343C (en)

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CN102949742A (en) * 2011-08-23 2013-03-06 富士胶片株式会社 Ventilation adapter, endoscope safekeeping tool, and sterilization method for endoscope
CN103889466A (en) * 2011-10-11 2014-06-25 美国消毒公司 Test pack to monitor effectiveness of sterilization process
CN108024690A (en) * 2015-05-15 2018-05-11 维兰德.K.沙马 System and method for the steam sterilizing of endoscope
CN108310399A (en) * 2017-01-16 2018-07-24 深圳市先赞科技有限公司 A kind of medical endoscope Double-sterilization method
CN110381802A (en) * 2017-03-31 2019-10-25 Hoya株式会社 The manufacturing method of endoscope-use flexible pipe and the manufacturing method of endoscope
CN111632179A (en) * 2020-05-25 2020-09-08 上海履济技术服务中心 Sterilization verifier and application thereof

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CN102949742A (en) * 2011-08-23 2013-03-06 富士胶片株式会社 Ventilation adapter, endoscope safekeeping tool, and sterilization method for endoscope
CN102949742B (en) * 2011-08-23 2017-04-12 富士胶片株式会社 Ventilation adapter, endoscope safekeeping tool, and sterilization method for endoscope
CN103889466A (en) * 2011-10-11 2014-06-25 美国消毒公司 Test pack to monitor effectiveness of sterilization process
CN103889466B (en) * 2011-10-11 2016-01-20 美国消毒公司 The test pack of the effect of monitoring sterilization treatment
CN108024690A (en) * 2015-05-15 2018-05-11 维兰德.K.沙马 System and method for the steam sterilizing of endoscope
CN108024690B (en) * 2015-05-15 2020-12-01 维兰德.K.沙马 System and method for steam sterilization of endoscopes
CN112402640A (en) * 2015-05-15 2021-02-26 维兰德.K.沙马 System and method for steam sterilization of endoscopes
CN108310399A (en) * 2017-01-16 2018-07-24 深圳市先赞科技有限公司 A kind of medical endoscope Double-sterilization method
CN110381802A (en) * 2017-03-31 2019-10-25 Hoya株式会社 The manufacturing method of endoscope-use flexible pipe and the manufacturing method of endoscope
CN110381802B (en) * 2017-03-31 2021-12-21 Hoya株式会社 Method for manufacturing flexible tube for endoscope and method for manufacturing endoscope
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