Containing device for handling and transporting medical instruments in protected manner

Abstract

Containing device for handling medical instruments in a protected manner, comprising: a container (11) in which one or more medical instruments are placed; at least one inlet (13) for the treatment liquid; and at least one lid (12) movable relative to the container (11) so as to selectively define a closed state and an open state.

Description

Technical Field

[0001] This invention relates to a receiving device for the protective handling (particularly cleaning and sterilization) and transport of medical devices (e.g., flexible endoscopes) in a hospital or outpatient setting, including the cleaning or handling process of the medical device and the subsequent transport process. The receiving device according to the invention can handle and transport tubular medical devices in a protected manner. Tubular medical devices are made of various materials, particularly metals, plastics, and / or rubber. In medicine, tubular medical devices are used to explore, examine, or empty natural cavities of the human body through optical devices and are introduced via natural or artificial means, such as rigid endoscopes, flexible fiber endoscopes, cystoscopes, ureteroscopes, resection devices, beam guides, glass syringes, endoscopic forceps and endoscopic bridges, ring nuts, or others.

[0002] The present invention also relates to a method and machine for processing medical devices. Background Technology

[0003] In hospital or outpatient settings, there are devices for the protective handling (particularly cleaning and sterilization) and transport of medical devices. These devices consist of a container and a lid, wherein the container holds the device to be processed, and the lid seals the container. These devices typically have an inlet on the lid for processing fluids (e.g., cleaning and sterilization solutions). These containers also have outlets for discharging the processed fluids that have undergone the specific treatment.

[0004] An example of a protective device for cleaning endoscopic medical instruments is disclosed in the applicant's international application WO2012 / 172403.

[0005] An example of a device for handling and transporting a medical device in a protected manner is disclosed in the applicant's international application WO2015 / 114578.

[0006] Machines for handling medical devices (such as endoscopic medical devices) used in clinical practice are known. These machines typically include a cleaning chamber in which the outer surfaces, inner surfaces, and channels of the endoscopic instrument are thoroughly cleaned using cleaning solutions, such as water and detergents, or chemical disinfectants, such as glutaraldehyde- or peracetic acid-based disinfectants.

[0007] The treatment of the outer surface of endoscopic instruments is typically achieved by immersing the instrument in the aforementioned treatment device, placing the instrument in the cleaning chamber, and connecting it to the cleaning circuit via a cannula. The treatment of the inner surface is achieved by connecting a flexible tube to the internal channels of the endoscopic instrument.

[0008] In this field, there is an urgent need to ensure that endoscopic instruments or general medical devices remain sterile after processing, during transport to the point of use, or while stored in a suitable warehouse awaiting transport to the point of use.

[0009] The problem with these known processing devices is that, under operating conditions, the time the processing fluid remains in the container within the processing machine does not reach the optimal length required to complete its intended operation (e.g., cleaning and sterilization). For example, the liquid may pass through the container too quickly, making it impossible to guarantee effective and uniform processing of the medical device.

[0010] Therefore, the aforementioned types of known processing devices cannot guarantee optimal processing operation for the medical devices placed therein, regardless of whether the medical devices are rigid or flexible.

[0011] Therefore, there is a need to improve the containment device for the protective handling and transport of medical devices so that it can overcome at least one of the disadvantages of the prior art.

[0012] Specifically, one object of the present invention is to provide a containment device for protective handling and transport that ensures effective handling steps, such as cleaning and sterilization, are performed on both rigid and flexible medical devices.

[0013] Another object of the present invention is to provide a containment device for the protective handling and transport of medical devices, which optimizes the persistence of the treatment fluid in the container holding the medical devices.

[0014] Another object of the present invention is to improve an effective and simple method for handling (e.g., cleaning and sterilizing) medical devices.

[0015] Another object of the present invention is to provide a machine for processing medical devices, wherein the receiving device can be placed in the machine.

[0016] The applicant designed, tested, and implemented the present invention to overcome the shortcomings of the prior art and to achieve these and other objectives and advantages. Summary of the Invention

[0017] The invention is set forth in the independent claims, which define its features. The dependent claims describe other features of the invention or variations of the main inventive concept.

[0018] In accordance with the above objectives, a containment device for handling medical devices in a protected manner is provided, comprising: a container in which one or more medical devices are placed; an inlet for at least one treatment fluid; and at least one lid movable relative to the container to selectively define a closed state and an open state of the containment device.

[0019] According to one aspect of the invention, the container includes a bottom having at least one hole, the at least one hole being calibrated to allow liquid discharge, and the discharge flow rate of the liquid being lower than the loading flow rate through the inlet.

[0020] Advantageously, this containment device ensures effective processing steps, such as cleaning and sterilization, for both rigid and flexible medical devices; in particular, due to the presence and proper calibration of a drain hole at the bottom of the container, the containment device optimizes the persistence of the processing solution within the container holding the medical device. Therefore, this hole significantly slows the drainage of liquid from the container and improves the persistence of the processing solution within the container, depending on the time required for a specific type of processing.

[0021] According to another aspect of the invention, the bottom has an upward-facing concave surface inside, and the hole is located at the lowest point of the bottom.

[0022] According to another aspect of the invention, the hole is at least partially covered by a plate connected to the cover by a connecting element and configured to allow at least one slow flow of liquid to exit from the hole, i.e., the liquid flows out through a slot defined by the hole and the plate that partially covers the hole.

[0023] According to another aspect of the invention, one or more gaskets are located between the plate and the bottom.

[0024] According to another aspect of the invention, the lid includes at least one orifice for escaping gas. This orifice can be properly calibrated, and due to the evacuation of gas from the container, the formation of bubbles and processing dead zones is avoided or at least limited.

[0025] According to another aspect of the invention, the hole is at least partially covered by a plate connected to the cover by a connecting element and configured to allow at least one gas passage to be formed from the hole.

[0026] According to another aspect of the invention, the lid has a downward-facing concave surface inside, and the hole is located at the highest point of the lid.

[0027] According to another aspect of the invention, one or more gaskets are placed between the plate and the cover.

[0028] The present invention also relates to a method for processing a medical device using the above-described containment device, comprising: placing the medical device in a container, and conveying a processing liquid into the container through at least one inlet, wherein the conveying flow rate of the processing liquid is greater than the flow rate of liquid discharged from at least one hole at the bottom of the container.

[0029] The present invention also relates to a machine for processing a medical device, comprising: a processing chamber and at least one pump configured to deliver a processing fluid to at least one containment device as described above, the containment device being located within the chamber. Attached Figure Description

[0030] These and other aspects, features, and advantages of the invention will become apparent from the following description of some embodiments, which are given by way of non-limiting examples in conjunction with the accompanying drawings, wherein:

[0031] Figure 1 This is a three-dimensional view of a containment device for handling and transporting a medical device in a protected manner, according to some embodiments described herein;

[0032] Figure 2 yes Figure 1 Partial exploded top view of the housing device shown.

[0033] Figure 3 yes Figure 1 Partial exploded bottom view of the housing shown.

[0034] Figure 3A yes Figure 3 A magnified view of a detail;

[0035] Figure 4 yes Figure 1 A three-dimensional cross-sectional view of the housing shown;

[0036] Figure 5 yes Figure 1 Longitudinal cross-sectional view of the container shown;

[0037] Figure 5A yes Figure 5 A magnified view of a detail;

[0038] Figure 6 This is a schematic diagram of a processing machine, in which a receiving device according to some embodiments described herein is placed.

[0039] It must be clarified that the wording and terminology used in this specification, the pictures in the accompanying drawings, and the manner of description serve only to better illustrate and explain the invention, and are intended to provide non-limiting examples of the invention itself, since the scope of protection of the invention is defined by the claims.

[0040] For ease of understanding, the same reference numerals are used to designate the same general elements in all the accompanying drawings where feasible. It should be understood that elements and features in one embodiment can be readily combined or incorporated into other embodiments without further explanation. Detailed Implementation

[0041] We will now describe in detail possible embodiments of the invention by way of non-limiting description, wherein one or more examples are illustrated in the accompanying drawings. The wording and terminology used herein are also intended to provide non-limiting examples.

[0042] Refer to the attached diagram, especially Figure 1 , Figure 2 and Figure 3 This describes some embodiments of a receiving device 10 for handling medical devices in a protected manner, the receiving device comprising: a container 11 in which one or more medical devices are placed; a processing fluid inlet 13; and a lid 12 movable relative to the container 11 to selectively define a closed state and an open state of the receiving device 10. The container 11 may be made of plastic, for example by molding.

[0043] Depending on the processing steps, the processing liquid can be, for example, a cleaning solution, a chemical disinfectant, a rinsing solution, or other liquid. Inlet 13 is specifically located on cover 12.

[0044] The housing 10 can be configured to be highly portable.

[0045] In some embodiments, the lid 12 is movable relative to the container 11 via a hinge, thereby allowing it to rotate relative to the container 11. In this case, the containing device 10 can be manufactured in the shape of a small box or case with a hinged lid, particularly a portable box or case with a portable hinged lid. For example, the lid 12 and the container 11 can be considered as two complementary parts of a box.

[0046] Alternatively, the lid 12 can be movable relative to the container 11 and can be completely removed from the container 11. In this case, the containing device 10 can be manufactured in the shape of a box with a fully removable lid, especially a portable box.

[0047] In some exemplary embodiments, in particular, the lid 12 is rotatable relative to the container 11 about an axis X, and is provided with hinges 41 along the axis X, for example, one, two, three or more hinges 41. For example, these hinges 41 are defined by hinge elements 14 of a suitable shape manufactured in the lid 12 or the container 11, which are inserted into a corresponding base 15 manufactured on one side of the container 11 or the lid 12.

[0048] When closed, the lid 12 can be securely attached to the container 11 via the knob 16. The knob 16 allows engagement of the protrusion 17, which is integral with the container 11, and the protrusion 18, which is integral with the lid 12. The protrusions 17 and 18 are located on opposite sides of the hinge 41.

[0049] There is a hollow gap 19 between the lid 12 and the container 11, see Figure 4 and Figure 5 A sealing gasket can be placed in the hollow gap 19. Specifically, the lid 12 is provided with a lip 20 around its circumference, which overlaps with the side portion of the container 11 when the lid 12 is closed.

[0050] In addition to the inlet 13, the cover 12 also includes an accessory 21 for performing a so-called “leakage test” in the case of a medical device to be processed that is an endoscope or similar device, wherein the endoscope or similar device includes electrical components and liquid leakage into the electrical components must be prevented.

[0051] Externally, the cover 12 is provided with a transport handle 22, and references Figure 3-3A The cover 12 is provided with at least one vent 23 for allowing gas to escape from the upper part of the housing 10. The vent 23 can be covered by a plate 24, specifically, covered from the outside of the cover 12, such as... Figure 1 and Figure 2 As shown, plate 24 is connected to cover 12 by connecting elements 25 such as screws or the like. Plate 24 is configured to allow at least one gas A passage, even a small one, to be formed from the vent 23. Plate 24 can be positioned at a distance from the vent 23 such that the plate allows gas A to pass through, for example, through a gasket 26, such as a washer or the like, or other means. This distance can also be adjusted by increasing or decreasing the tightness of the connecting elements 25. Plate 24 is located on the outer surface of cover 12.

[0052] Therefore, the vent 23 allows excess gas to escape from the containment device 10, thereby avoiding or significantly limiting the formation of bubbles in the treatment liquid during cleaning, sterilization, or rinsing operations. The vent 23 is always at least partially open, thus allowing for continuous gas venting.

[0053] The lid 12 may have a downward-facing concave surface, thus presenting a dome, cone, pyramid, or similar shape. The orifice 23 is located at the apex of the lid 12, and therefore at the highest point of the lid 12, to further facilitate the flow of gas into the orifice 23, thereby discharging it to the outside of the containing device 10. Therefore, the lid 12 has a downward-facing concave surface, so that when the lid is closed on the container 11, the lid 12 faces the container 11. This is merely an example. Figure 2 The dashed line L1 is shown, indicating the possible pyramid shape of the lid 12.

[0054] Container 11 includes a chamber 28 into which a medical device to be processed is placed. The medical device can be placed on a grid 29. Inlet 13 includes a fitting 30 located outside the cap 12 and a fitting 31 located inside the chamber 28. Fitting 31 can deliver the processing fluid directly into the chamber 28, or another T-shaped fitting can be attached to fitting 31 to provide a connection branch (e.g., a connection branch for endoscopic instruments) and a branch for pouring fluid into the chamber 28.

[0055] Therefore, if the medical device to be processed in chamber 28 is, for example, an endoscopic instrument or a similar instrument, it can be connected to inlet 13 and / or placed on grid 29.

[0056] See details Figure 4 , 5 5A, Container 11 includes a bottom 42 having at least one orifice 27 calibrated to allow liquid discharge at a rate lower than the loading flow rate through inlet 13. This allows the treatment fluid to remain in chamber 28 for a sufficient duration to effectively perform its intended operation, such as cleaning, sterilization, or rinsing. The orifice 27 is substantially always open, allowing liquid to drain in a controlled and calibrated manner.

[0057] The interior of the bottom 42 may have an upward-facing concave surface, thus being concave, inverted pyramidal, or similar in shape, and the orifice 27 is located at the lowest point of the bottom 42, thereby facilitating the flow of liquid into the orifice 27. The mesh 29 may be located within the chamber 28, at a distance from the bottom 42. Figure 3 The dashed line L2 schematically represents the inverted pyramid shape of the bottom 42.

[0058] The hole 27 can be at least partially covered, particularly from the outside of the container 11 via a plate 32, which is connected to the bottom 42 by a connecting element 34, for example, by screws or the like. Figure 5A As shown, plate 32 is configured to allow at least one slow flow of liquid L to exit from orifice 27, i.e., the liquid flows out through a slot defined by orifice 27 and the partially covered plate 32. Plate 32 may be located at a distance from orifice 27 to allow liquid L to drain, for example, through gasket 33, such as a washer or the like. Figure 5A The liquid L can be discharged, either as shown or by other means. This distance can also be adjusted by increasing or decreasing the tightness of the connecting element 34. The plate 32 is located on the outer surface of the bottom 42 and can be spaced at a minimum distance from the hole 27, for example, to allow a small, slow flow of liquid L, such as when a longer residence time of the liquid in the container 11 is desired.

[0059] The container 11 may also have one or more observation windows 35 or observation holes on one side. Alternatively, it may not have observation windows 35 or observation holes.

[0060] like Figure 6 As shown, the receiving device 10 is placed in the machine 36 for processing medical devices, particularly for cleaning, sterilizing, and rinsing medical devices. The machine 36 includes a processing chamber 37 in which the receiving device 10 is located.

[0061] The cap's inlet 13 is connected to a hydraulic circuit 38 for dispensing the treatment fluid, specifically via fitting 30. The treatment fluid is drawn from at least one reservoir 40 by a pump 39 and introduced into the receiving device 10. With a suitable control system, the pump 39 can be made to receive specific types of liquid from corresponding containers according to the processing steps.

[0062] Pump 39 delivers the treatment fluid into chamber 28 of the receiving device 10 at a flow rate greater than that of the treatment fluid flowing out from orifice 27, which is calibrated and located at the bottom 42 of container 11 of the receiving device 10 for this purpose.

[0063] The machine 36 may also be equipped with a heating device configured to heat the liquid to be introduced into the container 10.

[0064] Therefore, the method for processing medical devices requires placing the medical device in container 11 and then delivering the processing fluid into container 11 through an inlet, with the flow rate being greater than the flow rate of the liquid flowing out from the hole 27 made on the bottom 42 of container 11.

[0065] An example of a chemical sterilization cycle performed on a medical device by machine 36 within the housing 10 may include the following steps:

[0066] - Liquid is discharged for the first time from machine 36;

[0067] - A certain amount of treatment liquid is respectively loaded into the container 10 and the machine 36;

[0068] - Add detergent according to the percentage based on the type of cleaning to be performed;

[0069] - Heat the liquid to approximately 35°C;

[0070] - Allow the medical device to remain in the containment device 10 at 35°C for approximately 5 minutes;

[0071] - Drain the liquid;

[0072] - Refill the liquid, with some liquid being filled into the container 10 and some liquid being filled into the machine 36;

[0073] - Add disinfectant dosage according to the percentage based on the type of chemical sterilization to be performed;

[0074] - Heat the liquid to approximately 35°C;

[0075] - Allow the medical device to remain in the containment device 10 at 35°C for approximately 10 minutes;

[0076] - Drain the liquid;

[0077] - Refill the liquid, with some liquid into the container 10 and some liquid into the machine 36, without heating, for rinsing operation;

[0078] - Allow the liquid to remain in the device for approximately 2 minutes;

[0079] - Drain the liquid;

[0080] - It is possible to refill the liquid, with some liquid filling the container 10 and some liquid filling the machine 36, without heating, for additional rinsing operations;

[0081] - Allow the liquid to remain in the container 10 for approximately 2 minutes;

[0082] - The liquid is eventually discharged;

[0083] - Loop ends.

[0084] Obviously, modifications and / or additions can be made to the previously described containment device for handling and transporting medical devices in a protected manner without departing from the field and scope of the invention, the scope of which is defined by the claims.

[0085] In the following claims, the reference numerals in parentheses are for ease of reading only and should not be regarded as limiting factors of the scope of protection defined by the claims.

Claims

1. A receiving device (10) for handling a medical device in a protected manner, comprising: A container (11) in which one or more medical devices are placed; At least one inlet for the processing liquid (13); And at least one lid (12) movable relative to the container (11) to selectively define a closed state and an open state of the device (10), characterized in that the container (11) includes a bottom (42) having at least one hole (27) calibrated to allow liquid discharge at a rate lower than the loading rate through the inlet (13), the at least one hole (27) being at least partially covered by a plate (32) connected to the bottom (42) by a connecting element (34) and configured to allow at least one slow flow of liquid to flow out from the hole (27).

2. The receiving device (10) as claimed in claim 1, characterized in that, The bottom (42) has an upward concave surface inside, and the hole (27) is located at the lowest point of the bottom (42).

3. The receiving device (10) as claimed in claim 1, characterized in that, One or more gaskets (33) are located between the plate (32) and the bottom (42).

4. The receiving device (10) as described in any of the preceding claims, characterized in that, The cover (12) includes at least one hole (23) for escaping gas.

5. The receiving device (10) as claimed in claim 4, characterized in that, The hole (23) is at least partially covered by a plate (24) which is connected to the cover (12) by a connecting element (25) and is configured to allow at least one gas passage to be formed from the hole (23).

6. The receiving device (10) as claimed in claim 4 or 5, characterized in that, The cover (12) has a downward concave surface inside, and the hole (23) is located at the highest point of the cover (12).

7. The receiving device (10) as claimed in claim 5 or 6, characterized in that, One or more gaskets (26) are located between the plate (24) and the cover (12).

8. A method for processing a medical device using the receiving device (10) as described in any of the preceding claims, characterized in that, The method includes: placing the medical device inside the container (11); and delivering a treatment fluid into the container (11) through the at least one inlet (13), the flow rate of the treatment fluid being greater than the flow rate of liquid being discharged from at least one hole (27) made on the bottom (42) of the container (11).

9. A machine for processing medical devices, characterized in that, The machine includes a processing chamber (37) and at least one pump (39) configured to deliver a processing liquid to at least one containment device (10) as described in any one of claims 1 to 7, the containment device (10) being located in the processing chamber (37).

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