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Title:
CARRIER PIECE AND ENDOSCOPE CLEANING EFFICACY DETECTION DEVICE AND METHOD
Document Type and Number:
WIPO Patent Application WO/2018/022497
Kind Code:
A1
Abstract:
An embodiment of the present invention provides a carrier piece, and an endoscope cleaning efficacy detection device and method, belongs to the technical field of endoscope cleaning, and can solve the problems of inaccurate technical detection results, consuming much time, no real-time performance and troublesome operation of the existing endoscope cleaning efficacy detection. The carrier piece provided by an embodiment of the present invention is provided in an endoscope cleaning loop and has a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow. The endoscope cleaning efficacy detection device provided by an embodiment of the present invention comprises the carrier piece which is used in the endoscope cleaning efficacy detection method provided by the present disclosure.

Inventors:
ZENG, Feng (8 Xing Yi Road, Maxdo Center 38/F, Shanghai 6, 200336, CN)
LIU, Ting (No. 222 Tianhin Road, Shanghai 7, 200237, CN)
AHIMOU, Francois (3M Center, Post Office Box 33427Saint Paul, Minnesota, 55133-3427, US)
DUDA, RuthÃnn R. (3M Center, Post Office Box 33472Saint Paul, Minnesota, 55133-3427, US)
LI, Kang (Room 2206, No. 1Bi Yun Gong Guan,Lane 289 Zhe Qiao Road, Pu Dong District Shanghai 0, 200120, CN)
HU, Fangyuan (8 Xing Yi Road, Maxdo Center 38/F, Shanghai 6, 200336, CN)
Application Number:
US2017/043487
Publication Date:
February 01, 2018
Filing Date:
July 24, 2017
Export Citation:
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Assignee:
3M INNOVATIVE PROPERTIES COMPANY (3M Center, Post Office Box 33427Saint Paul, Minnesota, 55133-3427, US)
International Classes:
A61B1/12; B08B9/032
Attorney, Agent or Firm:
GOVER, Melanie G. et al. (3M Center, Office of Intellectual Property CounselPost Office Box 3342, Saint Paul Minnesota, 55133-3427, US)
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Claims:
CLAIMS:

1. A carrier piece provided in an endoscope cleaning loop comprising:

a support surface, the support surface having a simulation pollutant adhered thereon, wherein

a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow.

2. The carrier piece of claim 1, wherein

the simulation pollutant comprises a biomolecule, the biomolecule comprising at least one of adenosine triphosphate, alkaloid, nucleotide, protein, nucleic acid, a carbohydrate, and enzyme.

3. The carrier piece of claim 1, wherein

the simulation pollutant is a simulation pollutant visible to a naked eye.

4. The carrier piece of claim 1, wherein

the simulation pollutant contains a colored dye.

5. The carrier piece of claim 1, wherein

the support surface has a structure capable of forming a challenge to cleaning.

6. The carrier piece of claim 5, wherein

the support surface is a rough surface, a surface having a hole, or a surface having a groove.

7. The carrier piece of claim 1, wherein

the carrier piece comprises a through hole allowing the fluid to flow through. 8 The carrier piece of claim 7, wherein

the carrier piece is a reducer pipe.

9. The carrier piece of claim 8, wherein

the carrier piece is a conical reducer pipe.

10. The carrier piece of claim 8, wherein

an inner side surface and/or an outer side surface of the reducer pipe is the support surface.

11. An endoscope cleaning efficacy detection device, comprising:

a carrier piece provided in an endoscope cleaning loop and having a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow.

12. The endoscope cleaning efficacy detection device of claim 11, further comprising: a fixing piece connected to the endoscope cleaning loop and used for positioning the carrier piece.

13. The endoscope cleaning efficacy detection device of claim 12, wherein the fixing piece comprises first and second tubular parts,

the first part having a first end and a second end, the first end being connected with an opening of an endoscope;

the second part having a third end and a fourth end, the third end being connected with the second end and the fourth end being connected with an opening of an endoscope cleaning device; and

inner side surfaces of the first part and the second part being respectively provided with a first bulge and a second bulge thereon, the first bulge and the second bulge being used for positioning the carrier piece therebetween.

14. The endoscope cleaning efficacy detection device of claim 13, wherein

the carrier piece is a conical reducer pipe; and

when the carrier piece is positioned in the fixing piece, a bottom surface of the carrier piece faces a fluid inflow direction, and a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece and an inner surface of the fixing piece.

15. The endoscope cleaning efficacy detection device of claim 11, wherein

the carrier piece is a conical reducer pipe; and

the endoscope cleaning efficacy detection device further comprises a sampling piece, the sampling piece having a sampling portion and a connecting rod portion, the sampling portion comprising a truncated cone portion and a tapered portion, a bottom surface of the truncated cone portion being connected with the connecting rod portion, a top surface of the truncated cone portion being connected with a bottom surface of the tapered portion, the truncated cone portion being capable of being clamped in a bottom of the conical reducer pipe, the tapered portion being capable of being inserted into the conical reducer pipe, and a gap existing between an outer side surface of the tapered portion and an inner surface of the conical reducer pipe. 16. An endoscope cleaning efficacy detection device, comprising:

a carrier piece being a conical reducer pipe, an inner side surface and/or an outer side surface of the conical reducer pipe having a simulation pollutant adhered thereon, the simulation pollutant comprising adenosine triphosphate; and

a fixing piece comprising first and second tubular parts, one end of the first part being connected with an opening of an endoscope, the other end of the first part being connected with one end of the second part, and the other end of the second part being connected with an opening of an endoscope cleaning device; inner side surfaces of the first part and the second part being respectively provided with a first bulge and a second bulge thereon, the first bulge and the second bulge being used for positioning the carrier piece therebetween;

when the carrier piece is positioned in the fixing piece, a bottom surface of the carrier piece faces a fluid inflow direction, and a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece and an inner surface of the fixing piece.

17. An endoscope cleaning efficacy detection method, comprising:

providing a carrier piece in an endoscope cleaning loop, the carrier piece having a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow;

cleaning the endoscope by flushing a cleaning solution into the endoscope cleaning loop; and

after the cleaning is completed, determining an endoscope cleaning efficacy by evaluating the amount of the residual simulation pollutant on the support surface of the carrier piece.

Description:
CARRIER PIECE AND ENDOSCOPE CLEANING EFFICACY DETECTION DEVICE

AND METHOD

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Chinese Patent Application No. 2016106030620, filed July 27, 2016, the disclosure of which is incorporated by reference in its entirety herein.

The present invention belongs to the technical field of endoscope cleaning, and in particular relates to a carrier piece and an endoscope cleaning efficacy detection device and method.

BACKGROUND

An endoscope is also called "internal sight glass" and is widely applied to fields such as minimal invasion medical treatment and pipeline detection.

Obviously, the hygienic condition of the endoscope used in the field of medical treatment is very important. For this reason, a medical endoscope must be thoroughly cleaned and sterilized after every use. The cleaning of the external portion of the endoscope is comparatively simple. However, since the internal portion of the endoscope is relatively closed and the structure is very complex, it is very difficult to clean the internal portion. As shown in Fig. 1, in the existing endoscope cleaning method, an endoscope cleaning device 8 (for example, an OER automatic cleaning machine) is used, cleaning solution is flushed through an opening of the endoscope 9, and the cleaning solution flows inside the endoscope 9, then flows out from another opening of the endoscope 9 and finally enters the endoscope cleaning device 8 for cyclic use, thus an "endoscope cleaning loop" is formed, and through circulation after a period of time, the internal portion of the endoscope 9 can be completely cleaned.

However, since the openings in the endoscope are very small, it is difficult to directly observe the internal portion thereof through the openings. In other words, the endoscope cleaning efficacy (of the internal portion) cannot be effectively evaluated. Moreover, due to the difference in pollution levels, temperature, cleaning solution states, endoscope cleaning device states and the like, it cannot be guaranteed that the endoscope is certainly cleaned through cleaning after a specific time period. As a result, at present, it is very difficult to guarantee that the endoscope is fully cleaned. Consequently, medical accidents such as infection caused by uncleaned endoscope frequently happened.

In an existing method of detecting an endoscope cleaning efficacy, a detection plate carrying with a predetermined amount of harmless bacteria is provided in advance in the endoscope cleaning device, the bacteria on the detection plate are cultured after cleaning cycle is completed, the proportion of residual bacteria after cleaning is determined by observing the cultured bacteria flora and accordingly the endoscope cleaning efficacy is determined. However, since the detection plate is a flat plate and the internal structure of the endoscope is complex, the states of the cleaning solution which flows along the detection plate and along the endoscope are different, and the cleaning effects are different, thus neither does the cleanness of the detection plate represent that endoscope is completely cleaned, nor does the uncleanness of the detection plate represent that the endoscope is absolutely not completely cleaned. In addition, since bacteria culture is required, if the above-mentioned method is adopted, results can be obtained only after at least 48 hours, consuming much time, lacking real-time performance and making operation troublesome. Moreover, since the detection plate is a flat plate and the internal structure of the endoscope is complex, the states of the cleaning solution which flows along the detection plate and along the endoscope are different, and the cleaning effects are different, thus neither does the cleanness of the detection plate represent that endoscope is completely cleaned, nor does the uncleanness of the detection plate represent that the endoscope is absolutely not completely cleaned. In other words, the detection results thereof are very inaccurate.

SUMMARY

One aspect of the present invention is to provide a carrier piece, which is used for detecting an endoscope cleaning efficacy during endoscope cleaning and can obtain reliable results through a simple detecting method.

The carrier piece provided by the present invention is provided in an endoscope cleaning loop and has a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow.

Because the carrier piece of the present invention is provided in the endoscope cleaning loop and can enable the fluid flowing along the support surface to produce the turbulent flow, flow states of cleaning solution which flows along the support surface and along the internal portion of an endoscope are similar. Therefore, if the simulation pollutant is cleaned up, the endoscope is inevitably cleaned as well, and thus an endoscope cleaning efficacy can be determined by evaluating the amount of residual simulation pollutant. In addition, because what is provided on the support surface is the simulation pollutant instead of bacteria, the residual simulation pollutant can be easily observed without requiring cultivation and the like, thus the time spent in detection is short, the real-time performance is good, the operation is simple, and reliable results can be obtained through a simple detecting method.

As a preferred embodiment of the carrier piece provided by the present invention, the simulation pollutant comprises a biomolecule, the biomolecule comprising at least one of adenosine triphosphate, alkaloid, nucleotide, protein, nucleic acid, carbohydrate, and enzyme.

As a preferred embodiment of the carrier piece provided by the present invention, the simulation pollutant is a simulation pollutant visible to a naked eye; more preferably, the simulation pollutant contains a colored dye.

As a preferred embodiment of the carrier piece provided by the present invention, the support surface has a structure capable of forming a challenge to cleaning; more preferably, the support surface is a rough surface, a surface having a hole, or a surface having a groove.

As a preferred embodiment of the carrier piece provided by the present invention, the carrier piece comprises a through hole allowing the fluid to flow through.

As a preferred embodiment of the carrier piece provided by the present invention, the carrier piece is a reducer pipe.

As a preferred embodiment of the carrier piece provided by the present invention, the carrier piece is a conical reducer pipe.

As a preferred embodiment of the carrier piece provided by the present invention, an inner side surface and/or an outer side surface of the reducer pipe is the support surface. Another purpose of the present invention is to provide an endoscope cleaning efficacy detection device, which comprises the above-mentioned carrier piece and thus has the advantages of accurate detection results, good real-time performance and simple operation.

The endoscope cleaning efficacy detection device provided by the present invention comprises:

a carrier piece provided in an endoscope cleaning loop and having a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece at least enable a fluid flowing along the support surface to produce a turbulent flow.

As a preferred embodiment of the endoscope cleaning efficacy detection device provided by the present invention, the endoscope cleaning efficacy detection device further comprises: a fixing piece connected to the endoscope cleaning loop and used for positioning the carrier piece.

As a preferred embodiment of the endoscope cleaning efficacy detection device provided by the present invention, the fixing piece comprises first and second tubular parts, the first part having a first end and a second end, the first end being connected with an opening of an endoscope; the second part having a third end and a fourth end, the third end being connected with the second end and the fourth end being connected with an opening of an endoscope cleaning device; and inner side surfaces of the first part and the second part being respectively provided with a first bulge and a second bulge thereon, the first bulge and the second bulge being used for positioning the carrier piece therebetween.

As a preferred embodiment of the endoscope cleaning efficacy detection device provided by the present invention, the carrier piece is a conical reducer pipe; when the carrier piece is positioned in the fixing piece, a bottom surface of the carrier piece faces a fluid inflow direction, a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece and an inner surface of the fixing piece.

As a preferred embodiment of the endoscope cleaning efficacy detection device provided by the present invention, the carrier piece is a conical reducer pipe; and the endoscope cleaning efficacy detection device further comprises a sampling piece, the sampling piece having a sampling portion and a connecting rod portion, the sampling portion comprising a truncated cone portion and a tapered portion, a bottom surface of the truncated cone portion being connected with the connecting rod portion, a top surface of the truncated cone portion being connected with a bottom surface of the tapered portion, the truncated cone portion being capable of being clamped in a bottom of the conical reducer pipe, the tapered portion be capable of being inserted into the conical reducer pipe, and a gap existing between an outer side surface of the tapered portion and an inner surface of the conical reducer pipe.

Another purpose of the present invention is to provide at preferred endoscope cleaning efficacy detection device, which comprises:

a carrier piece being a conical reducer pipe, an inner side surface and/or an outer side surface of the conical reducer pipe having a simulation pollutant adhered thereon, the simulation pollutant comprising adenosine triphosphate; and

a fixing piece comprising first and second tubular parts, one end of the first part being connected with an opening of an endoscope, the other end of the first part being connected with one end of the second part, the other end of the second part being connected with an opening of an endoscope cleaning device;

and

inner side surfaces of the first part and the second part being respectively provided with a first bulge and a second bulge thereon, the first bulge and the second bulge being used for positioning the carrier piece therebetween;

when the carrier piece is positioned in the fixing piece, a bottom surface of the carrier piece faces a fluid inflow direction, and a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece and an inner surface of the fixing piece.

Another purpose of the present invention is to provide an endoscope cleaning efficacy detection method, which is performed by using the above-mentioned carrier piece and thus has the advantages of accurate detection results, good real-time performance and simple operation.

The endoscope cleaning efficacy detection method provided by the present invention comprises the following steps:

arranging a carrier piece in an endoscope cleaning loop, the carrier piece having a support surface, the support surface having a simulation pollutant adhered thereon, and a structure of the carrier piece can at least enable a fluid flowing along the support surface to produce a turbulent flow;

cleaning the endoscope by flushing a cleaning solution into the endoscope cleaning loop; and

after the cleaning is completed, determining an endoscope cleaning efficacy by evaluating the amount of residual simulation pollutant on the support surface of the carrier piece.

DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a schematic diagram of an existing method of cleaning an endoscope by using an endoscope cleaning device;

Fig. 2 shows a schematic diagram of a structure of a carrier piece having a different challenge according to the embodiment of the present invention;

Fig. 3 shows a schematic diagram of a sectional structure of the carrier piece in Fig. 2;

Fig. 4 shows schematic diagrams of sectional structures of other carrier pieces according to the embodiment of the present invention;

Fig. 5 shows a schematic diagram of structures of a disassembled fixing piece and a carrier piece according to the embodiment of the present invention;

Fig. 6 shows a schematic diagram of a sectional structure of a fixing piece in which a carrier piece is installed according to the embodiment of the present invention;

Fig. 7 shows a schematic diagram of a structure of a fixing piece when being connected into an endoscope cleaning loop according to the embodiment of the present invention;

Fig. 8 shows a schematic diagram of a structure of a sampling piece according to the embodiment of the present invention;

Fig. 9 is a schematic diagram of a local sectional structure of the sampling piece in Fig.

8;

Fig. 10 is a schematic diagram of a local sectional structure of the sampling piece in Fig. 8 when a fixing piece is taken out from a first part. In the drawings, reference signs are as follows: 1 -carrier piece; 11-support surface; 2-fixing piece; 21-first part; 211-first bulge; 22-second part; 221-second bulge; 3-sampling piece; 31-sampling portion; 311-truncated cone portion; 312-tapered portion; 32-connecting rod portion; 8-endoscope cleaning device; 9-endoscope.

DESCRIPTION OF THE EMBODIMENTS

In order to facilitate one skilled in the art to better understand the technical solution of the present invention, embodiments of the present invention will be further described below in detail in combination with the drawings and the embodiments.

In the present disclosure, the following terms or expressions have the following meanings:

Expression "A and/or B" indicates that situations of any one or two thereof may possibly occur, including three situations, i.e., "A and B", "A", and "B".

Expressions "A is substantially B", "A is approximately B" and "A is B on the whole" indicate that A satisfies the conditions of B on whole, but a certain difference may exist between A and B and the difference is very small when being viewed from the dimension of B.

"Simulation pollutant" refers to a substance which adheres onto a support surface and is used for simulating a pollutant condition, and can be gradually removed from the support surface or change in nature through cleaning after a certain time period, and itself has no toxic effect.

"Fluid" is a generic term of liquid and gas and is constituted by a great amount of molecules which continuously move and have no fixed balanced position, thus fluid has no fixed shape and has flow ability; in the present invention, fluid usually refers to "liquid", especially cleaning solution used for cleaning an endoscope.

"Turbulent flow" is also called as turbulence flow, disordered flow, disturbed flow and the like, usually spoken relative to laminar flow, and refers to at least part of fluid molecules moving in other directions besides moving in an overall flow direction of fluid.

"Reducer pipe" refers to a pipe with an inner diameter and an outer diameter thereof gradually changing in a length direction. In the drawings of the present invention, the number, dimension, dimension scale, relative position relationship and the like of each component are just exemplary expressions instead of limiting the specific structure of the corresponding component.

Carrier piece

As shown in Fig. 2 to Fig. 10, the embodiment of the present invention provides a carrier piece 1 ; the carrier piece 1 is provided in an endoscope cleaning loop and has a support surface 11, the support surface 11 having a simulation pollutant adhered thereon, and a structure of the carrier piece 1 can at least enable a fluid flowing along the support surface 11 to produce a turbulent flow.

During cleaning of an endoscope 9, the carrier piece 1 is provided in the endoscope cleaning loop, and cleaning solution flows through the carrier piece 1. In addition, the carrier piece 1 can enable the fluid flowing along the support surface 11 to produce the turbulent flow, i.e., enabling the flow state of the cleaning solution flowing along the support surface 11 to be similar to the flow state of the cleaning solution flowing along the internal portion of the endoscope 9, thus forming a "challenge". Therefore, if the simulation pollutant on the support surface 11 is cleaned up, the endoscope 9 is inevitably cleaned as well, and thus an endoscope cleaning efficacy can be reliably and accurately detected by using the carrier piece 1.

Preferably, as one of embodiments of the present invention, the simulation pollutant comprises adenosine triphosphate (ATP), i.e., the simulation pollutant contains a pollutant component, i.e., an adenosine triphosphate component.

In other words, the simulation pollutant containing the adenosine triphosphate component can be used. Specifically, the adenosine triphosphate can be dissolved in solution (such as 1 μg/ml adenosine triphosphate solution using polyvinyl alcohol as solvent), thereafter the solution is coated on the support surface 11, and after the solution is dried, the simulation pollutant comprising the adenosine triphosphate can be formed on the support surface 11.

The use of the simulation pollutant containing the adenosine triphosphate component has the following advantages: on one hand, since the adenosine triphosphate has an adhesive ability comparatively similar to conventional pollutants (such as bacteria and human body secretions) in the endoscope 9, the results are comparatively accurate when using the adenosine triphosphate to determine the endoscope cleaning effect; and on the other hand, the adenosine triphosphate is biomolecule, not bacteria, can be simply and quickly detected by directly adopting the existing fluorescence detection method without requiring cultivation in advance, thus the real-time performance for detection is good, the time spent in detection is short, and the operation is simple . The fluorescence detection method uses fluorescein and luciferase to react with the adenosine triphosphate to emit fluorescence (with wavelength of about 550nm to 620nm), and the amount of the adenosine triphosphate is confirmed by analyzing fluorescence intensity; and specifically, fluorescence detection can be performed by using the existing device, such as 3M Clean-Trace ATP fluorescence detector (purchased from 3M Company, St. Paul, Minnesota, US).

Because the operation of forming the simulation pollutant comprising the adenosine triphosphate component and the specific method of detecting the adenosine triphosphate are well-known, no detailed description is made here, and references can be made to patent documents such as US2015/257844A1, US2014/099233A1 and WO2014/058652A2.

Preferably, as another implementation of the embodiments of the present invention, the simulation pollutant may include other biomolecule, and the biomolecule that can be used specifically includes, but is not limited to, alkaloid, nucleotide, protein (e.g., hemoglobin), nucleic acid, carbohydrate, enzyme, etc. (of course, adenosine triphosphate as above may also be included). These biomolecules can also be quickly and accurately detected by adopting the existing method, which are not described in detail here.

Of course, it is also feasible to use a microorganism (e.g., bacteria) as the simulation pollutant.

Preferably, the simulation pollutant can also be a simulation pollutant visible to a naked eye; more specifically, the simulation pollutant contains a colored dye.

In other words, a substance which can be directly seen by a naked eye can also be used as the simulation pollutant, so that the cleaning result can be directly judged by a naked eye without using other equipment. For example, the simulation pollutant may be a substance which has an obvious color, or a colored dye may be added to the simulation pollutant that can hardly be seen by a naked eye. Specific available simulation pollutants visible to a naked eye include, but are not limited to, colored ink, animal blood, soybean sauce, tomato sauce, and the like.

Preferably, the support surface 11 of the carrier piece 1 has a structured capable of forming a challenge to cleaning.

In other words, the support surface 11 has a specific structure, and with such structure, it is more difficult to clean the simulation pollutant on the support surface 11 than to clean the simulation pollutant in the endoscope 9, i.e., a challenge is formed to the cleaning.

Specifically, as an implementation of the embodiment, the support surface 11 of the carrier piece 1 is a rough surface.

In other words, the support surface 11 can have a great amount of micro bulges, depressions and the like, so as to enable the surface thereof to become rough. Obviously, time spent for adequately cleaning the carrier piece 1 should be at least equivalent to (or may be longer than) time spent for adequately cleaning the endoscope 9; and in addition, since the pollution levels of the endoscopes 9 in different application environments are different, the actual time spent for adequate cleaning is different as well. Therefore, when different endoscopes 9 are cleaned, different carrier pieces 1 should be used such that the time spent for adequately cleaning the carrier piece 1 matches with the time spent for adequately cleaning the endoscope 9. In addition, by changing the roughness of the support surface 11, different challenges can be mimicked, i.e., the adhesive ability of the simulation pollutant can be changed, so as to change the time spent for adequately cleaning the carrier piece 1, such that the carrier piece 1 can adapt to different endoscopes 9.

Of course, the time spent for adequately cleaning the carrier piece 1 can also be realized by adjusting the shape of the carrier piece 1, the arrangement position of the carrier piece 1, the component of the simulation pollutant, the adhesion amount of the simulation pollutant and the like, as long as they match with the actual states of the endoscope, which are not described in detail here.

Specifically, as another implementation of the present invention, he support surface 11 of the carrier piece 1 may be a surface having holes, or a surface having grooves. In other words, the structure of the support surface 11 for forming a challenge may be holes (such as circular holes, square holes, strip-like holes), grooves (such as strip-like grooves, annular grooves), or the like arranged in a specific form, which are not described in detail here.

Preferably, the carrier piece 1 comprises a through hole allowing the fluid to flow through.

In other words, the carrier piece 1 therein can comprise a through hole allowing the fluid to flow through, such that at least part of cleaning solution flows through the through hole when the carrier piece 1 is provided in the endoscope cleaning loop. Therefore, the turbulent flow can be easily produced by changing the shape, inner diameter and the like of the through hole.

More preferably, the carrier piece 1 is a reducer pipe; and further preferably, an inner side surface and/or an outer side surface of the reducer pipe is the support surface 11.

Because the inner diameter and outer diameter of the reducer pipe gradually change along a length direction, the fluid flowing inside and outside a pipe lumen thereof inevitably produces the turbulent flow and thus either the inner side surface or the outer side surface thereof can be used as the support surface 11. In addition, since the states of the turbulent flows on the inner side surface and on the outer side surface of such carrier piece 1 are different, different simulation cleaning effects (or different challenges) can be produced thereby.

Therefore, how to provide the simulation pollutant on the carrier piece 1 can be determined according to the actual structure of the endoscope 9, so as to play the best role of detecting the endoscope cleaning effect.

Further preferably, the carrier piece 1 is a conical reducer pipe.

In other words, as shown in Fig. 2 and Fig. 3, the carrier piece 1 can have a truncated cone shape (or a conical shape with a head being cut off) and have a through hole distributed along an axial direction, wherein the shape of the through hole is also in a truncated cone shape such that the carrier piece 1 has uniform wall thickness.

When the fluid flows into the pipe lumen (through hole) from a wider end of the carrier piece 1, since the inner diameter of the pipe lumen is gradually reduced, the flow velocity of the fluid is gradually accelerated, a turbulent flow is produced and a challenge is formed; in addition, the fluid flowing along the outer side of the carrier piece 1 also passes through the gradually shrunk outer side surface of the carrier piece 1, thus a turbulent flow is produced and a challenge is formed.

Of course, the specific types of the carrier piece 1 described above should not be viewed as limiting the protection range of the present invention. It is feasible as long as the carrier piece 1 can be provided in the endoscope cleaning loop and the support surface 11 thereof can be enabled to produce the turbulent flow. For example, the through hole of the carrier piece 1 can also be bent; or the inner surface of the through hole of the carrier piece 1 can also be provided with structures such as bulges, baffles and grooves; or the outer surface of the carrier piece 1 can also be in different shapes such as circular shape and jujube arc shape; or the outer surface of the carrier piece 1 can be provided with structures such as bulges, baffles and grooves thereon; or the carrier piece 1 can also have a plurality of through holes therein; or the carrier piece 1 may have no through holes and the like therein. Fig. 4 shows examples of the carrier piece 1 in other partial types. However, it should be understood that these examples do not limit the protection range of the present invention, either.

Endoscope cleaning efficacy detection device

The embodiment of the present invention further provides an endoscope cleaning efficacy detection device. The endoscope cleaning efficacy detection device comprises the carrier piece 1 provided in an endoscope cleaning loop and having a support surface 11, the support surface 11 having a simulation pollutant adhered thereon, and a structure of the carrier piece 1 can at least enable a fluid flowing along the support surface 11 to produce a turbulent flow.

Preferably, as one embodiment of the present invention, the endoscope cleaning efficacy detection device further comprises a fixing piece 2 connected to the endoscope cleaning loop and used for positioning the carrier piece.

Obviously, an efficacy can be achieved only when the carrier piece 1 is provided in the endoscope cleaning loop. However, in the existing endoscope cleaning device 8 and the existing endoscope 9, there may be no proper position used for providing the carrier piece 1. Therefore, as shown in Fig. 7, the carrier piece 1 can be provided in the fixing piece 2 and then the fixing piece 2 is connected into the endoscope cleaning loop, such that the carrier piece 1 can be provided in the endoscope cleaning loop under the situation that the structure of the existing endoscope cleaning device 8 and the endoscope 9 are not changed.

As one embodiment of the present invention, as shown in Fig. 5 and Fig. 6, the fixing piece 2 comprises first and second tubular part 21, 22, the first part 21 having a first end (a left end in Fig. 5) and a second end (a right end in Fig. 5), the first end being connected with an opening of the endoscope 9; the second part 22 having a third end (a left end in Fig. 5) and a fourth end (a right end in Fig. 5), the third end being connected with the second end of the first part 2 land the fourth end (a right end in Fig. 5) connected with an opening of the endoscope cleaning device 8, and inner side surfaces of the first part 21 and the second part 22 being respectively provided with a first bulge 211 and a second bulge 221 thereon, the first bulge 221 and the second bulge 221 being used for positioning the carrier piece 1 therebetween.

In other words, the fixing piece 2 includes two tubular parts, wherein one end of the first part 21 can be connected to the opening of the endoscope 9 (such as a cleaning solution inlet), one end of the second part 22 can be connected to the opening of the endoscope cleaning device 8 (such as an opening of a liquid outlet pipe), and the other ends of the two parts can be mutually connected to form an integral tubular structure to hold the carrier 1 therein. In addition, the inner side surfaces of the first part 21 and the second part 22 are further respectively provided with a first bulge 211 and a second bulge 221 (such as a plurality of bumps or one annular bulge), and the carrier piece 1 should be guaranteed not to pass through the position of the bulge; after the first part 21 and the second part 22 are connected, the carrier piece 1 is limited at a position between the two bulges.

As shown in Fig. 6 and Fig. 7, when the endoscope 9 needs to be cleaned, the carrier piece 1 can be firstly placed in one part (for example, the first part 21) of the fixing piece 2, thereafter one ends of the two parts are connected together to form an integral tubular structure and the carrier piece 1 is enabled to be fixed between the two bulges thereof, and then the other end of the first part 21 is connected to the cleaning solution inlet of the endoscope 9 and the other end of the second part 22 is connected to the opening of the liquid outlet pipe of the endoscope cleaning device 8. Thereby, the fixing piece 2 is connected into the endoscope cleaning loop (or becomes a part of the endoscope cleaning loop), and correspondingly, the carrier piece 1 is naturally provided in the endoscope cleaning loop. After finishing the cleaning, the carrier piece 1 can be taken out by disassembling the fixing piece 2.

To reuse the fixing piece 2, the "connection" forms described above is preferably "detachable connection" form, i.e., a connection structure that can implement repeated connections and disconnections without being damaged. For example, the "detachable connection" form can be "clamping connection" forms. However, it should be understood that the specific detachable connection form is not limited and can also be any one of other forms such as thread connection.

Of course, it should be understood that the specific types of the fixing piece 2 do not limit the claimed scope of the present invention. For example, the structure of the endoscope 9 or the endoscope cleaning device 8 can also be adjusted, and a structure used for positioning the carrier piece 1 is directly provided therein, thus the fixing piece 2 is not used any longer (it can also be understood as that the fixing piece 2 and the endoscope 9 or the endoscope cleaning device 8 form an integral body); or the fixing piece 2 may not be divided into two parts but is merely a part which can be connected in the endoscope cleaning loop, and the carrier piece 1 is connected onto the fixing piece 2 by means such as clamping connection; or the fixing piece 2 and the carrier piece 1 together form an integral structure (it can also be understood as that the structure of the carrier piece 1 is changed); or the fixing piece 2 can also be provided at other position in the endoscope cleaning loop (e.g., between the liquid outlet opening of the endoscope 9 and the liquid inlet pipe of the endoscope cleaning device)..

Preferably, the carrier piece 1 is a conical reducer pipe; and when the carrier piece is positioned in the fixing piece 2, a bottom surface of the carrier piece faces a fluid inflow direction, a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece and an inner surface of the fixing piece 2.

In other words, as shown in Fig. 7, when the carrier piece 1 which is of the type of the conical reducer pipe, preferably the wider end of the carrier piece 1 faces the fluid inflow direction such that the fluid is enabled to flow from the wider end to the narrower end. According to researches, it is found that such arrangement of the carrier piece 1 more favorably facilitates the production of the turbulent flow.

In addition, as shown in Fig. 6, a gap exists between the outer side surface of the carrier piece 1 and the inner surface of the fixing piece 2. For example, the maximum outer diameter of the conical reducer pipe should be smaller than the inner diameter of the fixing piece 2 at the position of the conical reducer pipe, such that the fluid can be guaranteed to flow through the outer side of the carrier piece 1 and the outer side surface thereof can also be used as the support surface 11.

Obviously, the endoscope cleaning efficacy is obtained mainly by observing the simulation pollutant on the support surface 11. However, in the process of placing and taking out the carrier piece 1, the support surface 11 is very easily touched, thereby foreign pollutants are introduced or situation of the simulation pollutant is changed, and consequently the final detection results are influenced. Therefore, preferably a special sampling piece 3 can be used to operate the carrier piece 1.

Specifically, as one preferred embodiment of the present invention, the carrier piece 1 is a conical reducer pipe; and the endoscope cleaning efficacy detection device further comprises a sampling piece 3 having a sampling portion 31 and a connecting rod portion 32, the sampling portion 31 comprising a truncated cone portion 311 and a tapered portion 312, a bottom surface of the truncated cone portion 311 being connected with the connecting rod portion 32, a top surface of the truncated cone portion being connected with a bottom surface of the tapered portion 312, the truncated cone portion 311 being capable of being clamped in a bottom of the conical reducer pipe, the tapered portion 312 being capable of being inserted into the conical reducer pipe, and a gap existing between an outer side surface of the tapered portion and an inner surface of the conical reducer pipe.

In other words, as shown in Figs. 8 and 9, for the carrier piece 1 in the form of the conical reducer pipe, one end of a sampling piece 3 corresponding thereto is a sampling portion 31, the sampling portion 31 comprising a truncated cone portion 311, the outer side of the truncated cone portion 311 be capable of being clamped in the bottom of the carrier piece 1 (the conical reducer pipe), the top surface of the truncated cone portion 311 being provided with a tapered portion 312 (for example, similar to a conical structure) with diameter thereof gradually reducing in a direction far away from the truncated cone portion 311, and the tapered portion 312 being capable of being inserted into the carrier piece 1 but being not in contact with the inner side surface of the carrier piece 1, or a gap exists between the outer side surface thereof and the inner side surface of the carrier piece 1 ; in addition, the bottom surface of the truncated cone portion 311 is connected with a connecting rod portion 32 used for operation, and the connecting rod portion 32 can comprise a connecting rod with a certain length, a handle used for facilitating handholding and the like, which is not described in detail here.

Therefore, after finishing the cleaning, the fixing piece 2 as shown in Fig. 6 can be detached from the endoscope cleaning loop, then the first part 21 and the second part 22 of the fixing piece 2 can be disassembled, and the carrier piece 1 remains in the first part 21; at this point, as shown in Fig. 10, the sampling portion 31 can be inserted from the bottom of the carrier piece 1 by handholding the connecting rod portion 32 of the sampling piece 3 at this moment, so that the truncated cone portion 311 is enabled to be clamped by the bottom of the carrier piece 1, and thereafter the carrier piece 1 can be brought out from the first part by using the sampling piece 3 and is inserted into a chamber for detecting the above simulation pollutant (e.g., adenosine triphosphate, alkaloid, nucleotide, protein, nucleic acid, a carbohydrate, enzyme, etc.); since the gap exists between the outer side surface of the tapered portion 312 and the inner side surface of the carrier piece 1, solvent can enter from the gap to dissolve the simulation pollutant on the inner side surface of the carrier piece 1 for detection. Thereby, under the situation that the carrier piece 1 is not touched by hands at all, all operations of sampling and detection can be completed through simple operation.

Of course, the specific types of the sampling piece 3 do not limit the present invention. Other types of sampling piece 3 are feasible as long as operations of taking out and placing the carrier piece 1 can be performed under the situation that the support surface 11 is not polluted.

Also, if there is no special sampling piece 3, it is feasible to perform the operations of taking out and placing the carrier piece 1 through manual operation. Specifically, to sum up, as a preferred endoscope cleaning efficacy detection device of embodiments of the present invention, the endoscope cleaning efficacy detection device comprises:

a carrier piece 1 being a conical reducer pipe, an inner side surface and/or an outer side surface of the conical reducer pipe having a simulation pollutant adhered thereon, the simulation pollutant comprising adenosine triphosphate; and

a fixing piece 2 comprising first and second tubular parts 21, 22, one end of the first part 21 being connected with an opening of an endoscope 9, the other end of the first part 21 being connected with one end of the second part 22, and the other end of the second part 22 being connected with an opening of an endoscope cleaning device 8;

and

inner side surfaces of the first part 21 and the second part 22 being respectively provided with a first bulge 211 and a second bulge 221 thereon, the first bulge 211 and the second bulge 221 being used for positioning the carrier piece 1 therebetween;

when the carrier piece 1 is positioned in the fixing piece 2, a bottom surface of the carrier piece faces a fluid inflow direction, a top surface faces a fluid outflow direction and a gap exists between an outer side surface of the carrier piece 1 and an inner surface of the fixing piece 2.

Wherein, it is also feasible that the endoscope cleaning efficacy detection device further comprises the sampling piece 3.

The materials of parts such as the carrier piece 1, the fixing piece 2 and the sampling piece 3 in each endoscope cleaning efficacy detection device are not specially defined and can be conventional materials such as metallic and/or plastic materials, as long as the respective functions can be realized and no adverse influence is caused to the cleaning process of the endoscope 9.

Endoscope cleaning efficacy detection method

The embodiment of the present invention further provides an endoscope cleaning efficacy detection method, which is performed by employing the above described endoscope cleaning efficacy detection device. The method specifically comprises the following steps: Step 101 : providing a carrier piece 1 in an endoscope cleaning loop, the carrier piece 1 having a support surface, the support surface 11 having a simulation pollutant adhered thereon, and a structure of the carrier piece 1 can at least enable a fluid flowing along the support surface 11 to produce a turbulent flow.

Step 102: cleaning an endoscope 9 by flushing a cleaning solution into the endoscope cleaning loop.

Step 103 : after cleaning, determining an endoscope cleaning efficacy by evaluating the amount of residual simulation pollutant on the support surface 11 of the carrier piece 1.

In other words, the carrier piece 1 can be provided in the endoscope cleaning loop (for example, through a fixing piece 2), thereafter the cleaning solution is cyclically flushed into the endoscope cleaning loop by using an endoscope cleaning device 8 to clean the endoscope 9, the cleaning is completed through circulation after a certain time period, and the endoscope cleaning efficacy can be determined by observing the condition of the residual simulation pollutant on the support surface 11 of the carrier piece 1.

For the above simulation pollutant comprising adenosine triphosphate, as previously described, the fluorescence detection method is adopted for detection (for example, by using the 3M Clean-Trace ATP fluorescence detector) and the endoscope cleaning efficacy is determined by detecting the amount of the obtained residual adenosine triphosphate (it is considered to be acceptable when there is no residue or the residual amount is smaller than a predetermined amount).

For the simulation pollutant visible to a naked eye, the endoscope cleaning efficacy can be judged by directly observing the amount of the simulation pollutant with a naked eye (it is considered to be acceptable when there is no residue or the residual amount is smaller than a predetermined amount).

Alternatively, if the adopted simulation pollutant changes in nature during the cleaning (such as the color thereof gradually changes due to reaction with the cleaning solution), the endoscope cleaning efficacy can be judged by observing the change in nature.

Of course, the analysis of the residual simulation pollutant can be performed by employing different prior arts, which is not described in detail here. It can be understood that the above-mentioned embodiments are merely exemplary embodiments used for describing the principle of the present invention. However, the present invention is not limited thereto. One skilled in the art can make various variations and improvements without departing from the spirit and essence of the present invention. All such variations and improvements shall also be considered to be fallen into the scope of the present invention.