Support device for washing an endoscopic instrument

The support device for washing endoscopic instruments addresses the challenges of complex distal end disinfection by using a tubular element system with uniform fluid distribution and minimized contamination risks, achieving effective and targeted treatment.

WO2025057256A1PCT designated stage expired Publication Date: 2025-03-20STEELCO
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Patent Information

Application Number
PCT/IT2024/050183
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-13
Filing Date
2024-09-13
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Existing support devices for washing endoscopic instruments, particularly duodenoscopes, face challenges in effectively and safely disinfecting or sterilizing the complex distal ends due to chemical sensitivity, risk of contamination, and inability to use high-temperature sterilization methods.

Method used

A support device featuring an internal tubular element with a treatment chamber and through holes, combined with an external tubular element forming a hollow space connected to the chamber, allows for targeted washing, disinfection, or sterilization of the distal end. The device includes an inlet hole for uniform fluid distribution and an external outlet aperture positioned away from the inlet to minimize contamination risks.

Benefits of technology

The device ensures effective and targeted treatment of the distal end of endoscopic instruments, reduces contamination risks, and allows for easy cleaning and sterilization, addressing the limitations of existing devices.

✦ Generated by Eureka AI based on patent content.

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Abstract

Support device (10) configured to contain at least one distal end (100) of an endoscopic instrument to be subjected to washing and possible sterilization and / or disinfection. The device (10) comprises an internal tubular element, an external tubular element (16), a head portion (17) for the insertion of the distal end and a bottom portion (18) for the outflow of a dirty treatment fluid.
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Description

[0001] “SUPPORT DEVICE FOR WASHING AN ENDOSCOPIC INSTRUMENT”

[0002] FIELD OF THE INVENTION

[0003] The present invention concerns a support device for carrying out a targeted washing treatment on a distal end of an endoscopic instrument. Some embodiments described here also concern a method for treating an endoscopic instrument, for example a washing, disinfection or sterilization treatment.

[0004] BACKGROUND OF THE INVENTION

[0005] Endoscopes for carrying out diagnostic and / or therapeutic procedures in the human body are known. For example, flexible endoscopes used to diagnose and / or treat medical conditions affecting the lungs, esophagus, stomach, small intestine, biliary tract, pancreas or colon.

[0006] An endoscope is typically reused several times on different patients; therefore, after each use, it is necessary to perform a high-level disinfection to eliminate any bacterial loads from it.

[0007] Generally, endoscopes can comprise at least one material that is chemically sensitive and / or subject to degradation over time and with use. In addition, endoscopes can have a complex shape and contain steam sensitive components and / or adhesives, not being able to be sterilized in an autoclave using heat.

[0008] Therefore, most modem endoscopic instruments cannot be sterilized, with sterilization being understood as the complete removal or destruction of all microbial cells or spores present on the instrument.

[0009] Endoscopes therefore undergo disinfection, that is, the removal or destruction of most, but not all, microbial cells or spores. Many treatment systems use a combination of chemical agents and moderate heat to achieve a high level of disinfection. But this approach can be ineffective, particularly in the case of endoscopes that have a complex structure, such as duodenoscopes.

[0010] In correspondence with a distal end, duodenoscopes have a structure able to modify the angle of the catheters, which is called a forceps elevator or fin, and a channel associated with it. The forceps elevator can be rotated between a lowered position, in which it is substantially aligned with a longitudinal axis of the endoscope allowing it to slide in the human body, and a raised position, in which it is rotated with respect to such axis and protrudes transversely to be able to exert an action of opening a part of the duodenum. The elaborate shape of the distal end complicates the disinfection of the duodenoscope, which is guaranteed by international guidelines for the sanitization of duodenoscopes.

[0011] IT 102019000013233 describes a positioning and support device for the treatment of an endoscopic instrument suitable for the application of international guidelines for the sanitization of duodenoscopes. This device provides an inlet for a treatment fluid at inlet, and a discharge outlet for the outflow of the dirty treatment fluid in correspondence with a same end of the device. This leads to the disadvantage of having to provide a complex conformation of the device in correspondence with such end, in order to reduce the risk of contamination of the treatment fluid at inlet with the one at outlet.

[0012] There is therefore the need to perfect a support device for washing an endoscopic instrument that can overcome at least one of the disadvantages of the state of the art. To do this, it is necessary to solve the technical problem of providing a high- level washing, sterilization and / or disinfection treatment that acts effectively and in a targeted manner on the distal end of an endoscopic instrument, for example a duodenoscope.

[0013] In particular, one purpose of the present invention is to provide a support device for washing an endoscopic instrument that allows to increase the effectiveness of the washing treatment of the aforementioned distal end of the endoscope.

[0014] Another purpose of the present invention is to provide a support device that allows for high ease of use.

[0015] Another purpose of the present invention is to provide a support device that is simple to clean and subject to sterilization.

[0016] Another purpose of the present invention is to perfect a method for treating endoscopes that allows to perform a punctual treatment of their distal end.

[0017] The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

[0018] SUMMARY OF THE INVENTION

[0019] The present invention is set forth and characterized in the independent claim. The dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

[0020] In accordance with the above purposes and to resolve the technical problem described above in a new and original way, also achieving considerable advantages compared to the state of the prior art, a support device according to the present invention for containing at least one distal end of an endoscopic instrument to be subjected to washing and possible sterilization and / or disinfection, comprises an internal tubular element having a body defining a treatment chamber inside it which is configured to house and accommodate the distal end. The internal tubular element’s body is provided with a plurality of through holes. The device also comprises an external tubular element coaxially associated with the internal tubular element, in such a way as to at least partly contain it and with it define a hollow space fhiidically connected to the chamber through the holes.

[0021] The device comprises a head portion in correspondence with a first end thereof, suitable for the insertion of the distal end to be treated in the device, and an opposite bottom portion configured to allow the outflow of a treatment fluid from the chamber.

[0022] In accordance with one aspect of the present invention, the device comprises an inlet hole for the treatment fluid, configured to put suitable means for feeding the fluid in fluidic communication with the hollow space and provided in correspondence with a substantially central zone of the hollow space.

[0023] The substantially central position of the inlet hole with respect to the hollow space gives at least the advantage of achieving an essentially uniform distribution of the treatment fluid in the hollow space itself, before the introduction of the fluid into the treatment chamber. This also achieves the advantage of providing a support device with a simple structure, which allows for an effective treatment of the distal end of an endoscopic instrument, and which is simple both to use as well as to clean and / or sterilize.

[0024] In accordance with another aspect of the present invention, the hollow space is closed in correspondence with opposite ends thereof which face toward the head and bottom portions, respectively.

[0025] In accordance with another aspect of the present invention, the inlet hole is provided in correspondence with a central ring of the external tubular element.

[0026] In accordance with another aspect of the present invention, the inlet hole is configured for the coupling with an inlet adapter, suitable for connection with feed means suitable to deliver the treatment fluid.

[0027] In accordance with another aspect of the present invention, the bottom portion comprises a bottom wall conformed as a ring, in the central portion of which at least one external outlet aperture is created for the outflow of the dirty treatment fluid from the chamber.

[0028] Advantageously, the external outlet aperture is distant from the inlet hole, so that the risk of contamination of the treatment fluid at inlet by the dirty treatment fluid at outlet is essentially eliminated or dramatically reduced compared to the prior art.

[0029] In accordance with another aspect of the present invention, the bottom wall comprises at least one dividing element configured to divide the external outlet aperture into sub-apertures. Advantageously, during use the dividing element can prevent the distal end from exiting from the treatment chamber, which would nullify the treatment itself.

[0030] In accordance with another aspect of the present invention, the disposition of the holes follows a pattern correlated to the conformation of the distal end to be treated.

[0031] In accordance with another aspect of the present invention, the device also comprises a closing element configured to at least partly close an internal aperture for the insertion of the head portion, simultaneously allowing the insertion of the distal end to be treated into the device.

[0032] In accordance with another aspect of the present invention, the internal and external tubular elements are made of polymer plastic material chosen from polyoxymethylene, polypropylene or polypropylene modified with glass fiber.

[0033] Some embodiments described here also concern a method for washing a distal end of an endoscopic instrument with a device according to the present invention.

[0034] In accordance with another aspect of the present invention, the method provides to insert the distal end to be treated into the chamber, connect the inlet hole to means for feeding a treatment fluid, deliver the treatment fluid through the inlet hole in such a way that it is distributed in the hollow space, it passes through the holes and is delivered in the form of jets into the chamber, acting on the distal end from different directions, and discharge the treatment fluid with any residual dirt from the chamber through the bottom portion.

[0035] DESCRIPTION OF THE DRAWINGS

[0036] These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

[0037] - fig. 1 is a perspective view of a support device for washing an endoscopic instrument according to the present invention;

[0038] - fig. 2 is an exploded view of the device of fig. 1;

[0039] - fig. 3 is a cross-section of the device of fig. 1 according to a symmetry plane P thereof;

[0040] - fig. 4 is a cross-section of the device of fig. 1 containing a distal end of an endoscopic instrument, according to the plane P.

[0041] We must clarify that the phraseology and terminology used in the present description, as well as the figures in the attached drawings also in relation as to how described, have the sole function of better illustrating and explaining the present invention, their purpose being to provide a non-limiting example of the invention itself, since the scope of protection is defined by the claims.

[0042] To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can be conveniently combined or incorporated into other embodiments without further clarifications.

[0043] DESCRIPTION OF SOME EMBODIMENTS

[0044] With reference to fig. 1, a support device 10 for washing an endoscopic instrument according to the present invention is configured to be able to contain at least one distal end 100 of an oblong body, that is, having a prevalent size along a longitudinal development, for example the terminal part of an endoscopic instrument to be subjected to a washing treatment and possible sterilization and / or disinfection. The device 10 can be used alone or in conjunction with endoscopic instrument treatment machines. In some embodiments, the device 10 comprises a hollow internal tubular element 11 (figs. 1-4). A body 12 (fig. 2) of the internal tubular element 11 can delimit and define therein a treatment chamber 13, configured to house and accommodate the distal end 100 of the oblong body to be treated (fig. 4), for example the body of an endoscopic instrument such as a duodenoscope.

[0045] The device 10 can also comprise a hollow external tubular element 16 (figs. 1- 4), coaxially associated with the internal tubular element 11 in such a way as to at least partly contain it. The external 16 and internal 11 tubular elements are configured so as to contribute to defining, when they are coaxially associated, a hollow space 19 (figs. 3-4).

[0046] According to possible embodiments, the hollow space 19 has an annular shape and a substantially constant width along its longitudinal development. The hollow space 19 is configured to act as a distribution chamber for a treatment fluid, before the latter is introduced into the chamber 13.

[0047] A plurality of through holes 14 can be provided on the body 12 of the internal tubular element 11 (figs. 2-4), which are configured to put the hollow space 19 in fluidic communication with the chamber 13. The holes 14 can be single diameter or flared, for example narrowing toward the chamber 13 to generate greater pressure.

[0048] According to possible embodiments, the holes 14 can be of the same size. In alternative embodiments, the holes 14 can have different sizes.

[0049] The device 10 can comprise, in correspondence with a first end thereof, a head portion 17 suitable for the insertion of the distal portion 100 to be treated, and in correspondence with an opposite end, a bottom portion 18 configured to allow the outflow of the treatment fluid from the chamber 13.

[0050] According to possible embodiments, the internal tubular element 11 is longer than the external tubular element 16, so that a neck portion 20 of the internal tubular element 11 protrudes from the external tubular element 16, in correspondence with the head portion 17 of the device 10 (figs. 2-4).

[0051] In some embodiments, the hollow space 19 and the chamber 13 are essentially as long as the external tubular element 16, and the entire device 10 is essentially as long as the internal tubular element 11.

[0052] The device 10 comprises an inlet hole 21 for the treatment fluid, configured to put suitable means for feeding the treatment fluid in fluidic communication with the hollow space 19.

[0053] The inlet hole 21 can be provided in an external portion of the device 10 in correspondence with an essentially central zone of the hollow space 19, for example in correspondence with a central ring 15 of the external tubular element

[0054] 16. The central ring 15 can be made in a single body with the external tubular element 16.

[0055] In some embodiments, on the central ring 15 there can be provided an attachment mean, for example a pin 25, for attaching the device 10 to an external container, device or support, such as a washing basket.

[0056] The essentially central position of the inlet hole 21 with respect to the hollow space 19 advantageously allows for an essentially uniform distribution of the treatment fluid in the hollow space 19 itself, before the introduction of the fluid into the chamber 13.

[0057] In some embodiments, the inlet hole 21 is configured for coupling with an inlet adapter 22, suitable for connection with feed means suitable to deliver the treatment fluid.

[0058] In some embodiments, the external tubular element 16 comprises, in correspondence with the bottom portion 18, at least one external outlet aperture 24. The external outlet aperture 24 is communicating with the chamber 13 and is configured to allow the discharge and outflow of the dirty treatment fluid from the chamber 13, that is, after the fluid has come into contact with the distal end 100 to be treated.

[0059] Advantageously, the external outlet aperture 24 is distant from the inlet hole 21, so that the risk of contamination of the treatment fluid at inlet by the dirty treatment fluid at outlet is essentially eliminated or drastically reduced.

[0060] In some embodiments, the hollow space 19 is closed in correspondence with opposite ends thereof facing toward the head portion 17 and the bottom portion 18 of the device 10, respectively. Consequently, the treatment fluid can be delivered to the hollow space 19 only through the inlet hole 21 and can exit the hollow space 19 only through the holes 14.

[0061] The external tubular element 16 can comprise, in proximity to the head portion

[0062] 17, an external insertion aperture 27 configured to allow the insertion therein of the internal tubular element 11.

[0063] In correspondence with the bottom portion 18, the internal tubular element 11 can comprise at least one internal outlet aperture 23, adjacent to the external outlet aperture 24 and configured to allow the discharge and the outflow of the dirty treatment fluid from the chamber 13.

[0064] The internal tubular element 11 can comprise, in proximity to the head portion 17, an internal insertion aperture 26 configured to allow the insertion therein of the distal end 100 to be treated. According to possible embodiments, the tubular elements 11 and 16 can be made of polymer plastic material, for example polyoxymethylene, polypropylene or polypropylene modified with glass fiber. Preferably, the polymer plastic material allows the device 10 to withstand the conditions of the washing and / or sterilization or disinfection treatment, such as temperatures above 100°C and / or contact with acid or alkaline cleaning fluids and / or high pressures.

[0065] The bottom portion 18 can comprise a bottom wall 28, in the central portion of which the at least one external outlet aperture 24 for the outflow of the dirty treatment fluid from the chamber 13 is created. The sizes of the external outlet aperture 24 can be chosen according to the volume of fluid that has to be drained from the chamber 13 so that no dirty fluid stagnates therein.

[0066] In some embodiments, the bottom wall 28 is conformed as a ring, so as to guarantee, in correspondence with its periphery, the closure of the hollow space 19 while allowing, in correspondence with its center, the outflow of the dirty treatment fluid from the outlet apertures 23, 24. The bottom wall 28 can comprise one or more dividing elements 37 configured to divide the external outlet aperture 24 into sub-apertures 24a.

[0067] As shown in figs. 2-4, a dividing element 37 can divide the outlet aperture 24 in half. Advantageously, during use the dividing element 37 can prevent the exit of the distal end 100 from the chamber 13, which would nullify the cleaning, disinfection and / or sterilization treatment. Preferably, the sizes of the sub-apertures

[0068] 24a are such as to allow any dirt residues to escape, thus preventing blockages.

[0069] The internal tubular element 11 can comprise, in a terminal portion of the body 12 adjacent to the neck portion 20, a shoulder 29 that extends transversely with respect to the longitudinal axis and has a larger diameter than that of the body 12. The shoulder 29 can have a diameter substantially equal to an internal diameter of the external tubular element 16, so that it can be positioned in contact with the latter in such a way as to close the hollow space 19 in correspondence with the external insertion aperture 27. The holes 14 can be made in the body 12 along its longitudinal extension. The neck portion 20 and an opposite terminal portion of the internal tubular element 11 can be substantially free of holes 14.

[0070] The disposition of the holes 14 in the body 12 can be chosen so as to generate jet types that are functional to the treatment of the distal end 100. For example, the holes 14 can be disposed in a helix, so as to generate rotating jets; they can be equally distributed, or they can be disposed with a higher density in correspondence with and / or in relation to the complexity of the corresponding zone of the distal end 100. Moreover, the disposition of the holes 14 can follow a pattern correlated to the conformation of the distal end 100.

[0071] In some embodiments, one or more holes 14 can be made in the thickness of the shoulder 29 and configured to allow the passage of the treatment fluid from the hollow space 19 toward the neck portion 20.

[0072] According to possible embodiments, at the base of the neck portion 20 there can be provided a ring-shaped striker portion 30, protruding beyond the shoulder 29 and configured to be resting on the edge of the external insertion aperture 27 when the internal tubular element 11 is inserted in the external tubular element 16.

[0073] The external tubular element 16 can comprise, in proximity to the external insertion aperture 27, first coupling means 32 configured to cooperate with respective second coupling means 33 of the internal tubular element 11 to allow a substantially hermetic coupling between the two tubular elements 11, 16.

[0074] The coupling can be same-shape, or snap-in, or screw-in, or any other suitable type. The second coupling means 33 can comprise a protruding tooth, while the first coupling means 32 can comprise a coupling seating suitable to accommodate the tooth, thus realizing a snap-in shape coupling.

[0075] In some embodiments, the device 10 also comprises a closing element 34, for example a lid or a cap, which is configured to at least partly close the internal insertion aperture 26.

[0076] The closing element 34 can be configured to be associated with the neck portion 20. For example, the closing element 34 can have a cylindrical shape with a diameter suitable to be coupled by interference with the neck portion 20.

[0077] According to possible embodiments, during use the closing element 34 can have its own closing wall 35 abutting against the edge of the internal insertion aperture 26 and the edge of an opposing open end abutting against the striker portion 30.

[0078] The closing wall 35 can be provided with one or more cuts, for example a crossshaped cut, which generates a plurality of flaps 36 (figs. 1, 3-4) configured to accommodate the endoscopic instrument by flexing toward the inside of the device 10 at the same time as the insertion of the distal end 100 of the instrument.

[0079] Advantageously, the flaps 36 allow to keep the distal end 100 substantially centered within the chamber 13 and they limit, during use, the exit of any treatment fluid therefrom.

[0080] In some embodiments, the closing element 34 is made of elastomeric material, preferably silicone or other suitable material.

[0081] Some embodiments described here also concern a method for washing a distal end 100 of an endoscopic instrument with a device 10 according to the invention.

[0082] The washing method comprises:

[0083] - inserting the distal end 100 to be treated into the chamber 13; - connecting the inlet hole 21 to means for feeding a treatment fluid, for example through the inlet adapter 22;

[0084] - delivering a treatment fluid through the inlet hole 21 in such a way that it is distributed in the hollow space 19, it passes through the holes 14 and is delivered into the chamber 13 in the form of jets, acting on the distal end 100 from different directions;

[0085] - discharging the treatment fluid with any residual dirt from the chamber 13 through the external outlet aperture 24.

[0086] According to some embodiments, the method provides to deliver a treatment fluid under pressure. The delivery pressure can be correlated to the shape, type, and / or condition of maximum contamination of the distal end 100 of the endoscopic instrument to be cleaned.

[0087] It is clear that modifications and / or additions of parts may be made to the device 10 and to the method as described heretofore, without thereby departing from the field and scope of the present invention, as defined by the claims. It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art will be able to achieve other equivalent forms of support device for washing an endoscopic instrument, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

[0088] In the following claims, the sole purpose of the references in brackets is to facilitate their reading and they must not be considered as restrictive factors with regard to the field of protection defined thereby.

Claims

CLAIMS1. Support device (10) containing at least one distal end (100) of an endoscopic instrument comprising:- an internal tubular element (11) having a body (12) defining inside it a treatment chamber (13) which is configured to house and accommodate said distal end (100), said body (12) being provided with a plurality of through holes (14);- an external tubular element (16) coaxially associated with said internal tubular element (11), in such a way as to at least partly contain it and together define a hollow space (19) fluidically connected to said chamber (13) through said holes (14);- a head portion (17) in correspondence with a first end thereof, suitable for the insertion of said distal end (100), and an opposite bottom portion (18) configured to allow the outflow of a treatment fluid from said chamber (13), characterized in that it comprises an inlet hole (21), provided in a substantially central zone of the hollow space (19), configured to put suitable means (22) for feeding the treatment fluid in fluidic communication with said hollow space (19).

2. Device (10) as in claim 1 , characterized in that said hollow space (19) is closed in correspondence with opposite ends thereof which face toward said head (17) and bottom (18) portions, respectively.

3. Device (10) as in any claim hereinbefore, characterized in that said inlet hole (21) is provided in correspondence with a central ring (15) of said external tubular element (16).

4. Device (10) as in any claim hereinbefore, characterized in that said inlet hole (21) is configured for the coupling with an inlet adapter (22), suitable for connection with feed means suitable to deliver said treatment fluid.

5. Device (10) as in any claim hereinbefore, characterized in that said bottom portion (18) comprises a bottom wall (28) conformed as a ring, in the central portion of which at least one external outlet aperture (24) is created for the outflow of the dirty treatment fluid from said chamber (13).

6. Device (10) as in claim 5, characterized in that said bottom wall (28) comprises at least one dividing element (37) configured to divide said external outlet aperture (24) into sub-apertures (24a).

7. Device (10) as in any claim hereinbefore, characterized in that the dispositionof said holes (14) follows a patern correlated to the conformation of said distal end (100).

8. Device (10) as in any claim hereinbefore, characterized in that it comprises a closing element (34) configured to at least partly close an internal aperture (26) for the insertion of said head portion (17), simultaneously allowing the insertion of said distal end (100) into said device (10).

9. Device (10) as in any claim hereinbefore, characterized in that said tubular elements (11, 16) are made of polymer plastic material chosen from polyoxymethylene, polypropylene or polypropylene modified with glass fiber.

10. Method for washing a distal end (100) of an endoscopic instrument with a device (10) as in any claim hereinbefore, characterized in that it comprises:- inserting said distal end (100) into said chamber (13);- connecting said inlet hole (21) to means for feeding a treatment fluid so as to- deliver said fluid in such a way that it is distributed in said hollow space (19), it passes through said holes (14) and is delivered in the form of jets into said chamber(13), acting on said distal end (100) from different directions;- discharging said fluid with any residual dirt from said chamber (13) through said botom portion (18).

Citation Information

Patent Citations

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