Protective equipment for cleaning endoscopic medical instruments, such as transesophageal probes or the like

Abstract

Protective equipment (10) for cleaning medical endoscopic instruments (100), such as transesophageal probes or the like, comprising a tubular part (120) to be cleaned, which contains electronic components (110) to be protected at one end, including a hydraulically sealed box body (11) which internally defines a receiving compartment (12) to house the electronic components (110) in a state protected from the outside, wherein the box body (11) comprises a first bottom part (13) to house the electronic components (110) and a second closing part (14) configured to selectively couple with the first part (13) between a closed state in which the second part (14) completely covers the first part (13) and protects the electronic components (110) in the receiving compartment (12), and a separate state.in which the second part (14) is spaced apart from the first part (13) and allows access to the receiving compartment (12), characterized in that the first part (13) comprises a first coupling edge (19) having at least one first unique coupling section (21) and that the second part (14) comprises a second coupling edge (20) configured to be selectively coupled to this first coupling edge (19) and having at least one second unique coupling section (22) configured to be symmetrically arranged, positively interlocking, and uniquely assigned to the first unique coupling section (21).

Description

AREA OF APPLICATION

[0001] The present invention relates to protective equipment for cleaning medical instruments in the form of tubes made of various materials, in particular metal, plastic and / or rubber, which are used in medicine to explore, examine with optical devices or empty natural cavities of the body, and which are inserted naturally or artificially.The present invention is applicable, for example, to the cleaning, thermal disinfection and / or chemical disinfection and drying of medical instruments which, in addition to a tubular part, a so-called insertion tube, which is normally flexible and extended and is inserted into the human body for the purpose of clinical examination and must be subjected to a cleaning / disinfection treatment for reuse, are also equipped with electronic components such as transesophageal or similar probes that are sensitive to moisture and contact with water. STATE OF THE ART

[0002] Endoscopic medical instruments that become soiled during use are cleaned in a special cleaning chamber of a cleaning device. Endoscopic instruments typically have a flexible tube, also called an introducer tube, which is inserted into the patient's body and has a variable length and diameter depending on the application. Inside the tube, depending on the device's specific design, channels of varying sizes and for different purposes may be arranged or configured, for example, for biopsy, camera inspection, illumination, and the spraying of air and / or water.In the cleaning chamber, the complete cleaning treatment of both the outer and inner surfaces and the channels of the endoscopic instrument takes place in a first phase with cleaning fluids such as water and detergents and in a second phase with a chemical disinfectant, for example based on glutaraldehyde or peracetic acid.

[0003] The cleaning chamber may be equipped with flexible hoses for connection to any internal channels of the endoscopic instrument, which are connected via a suitable waterproof connection to the appropriate devices for the cleaning fluid of the cleaning device.

[0004] Instead, the outer surface of the endoscopic instrument is treated in the cleaning chamber of a special cleaning device by spraying the cleaning fluid to reach the entire outer surface of the insertion tube.

[0005] Furthermore, such an auxiliary hose protects the insertion hose from unwanted impacts and friction during cleaning.

[0006] For medical instruments of this type, which are equipped with highly moisture-sensitive electronic components, direct contact with water and moisture must be avoided to prevent impairing the functionality of these components. Indeed, damage or malfunction of such expensive electronic components is highly likely upon contact with water, and this is unacceptable. A unique feature of these instruments is that it is not possible to detach the electronic components, located at one end of the insertion tube, from the tube for cleaning purposes.

[0007] Such electronic components are usually located at one end of the tubular part and must be protected during such treatments, as they are very sensitive to moisture, water and other cleaning agents.

[0008] In this sense, protective devices with a closed, hydraulically sealed box body and an internally demarcated receiving compartment are known to accommodate the electronic components of the instrument through an opening in a state protected from the outside.

[0009] Solutions are also known in which the box body consists of at least two interconnected parts: a first bottom part for receiving the electronic components to be protected and a second closing part, which are selectively movable relative to each other, for example by means of a mutually attached hinge device, between a closed state in which the second part completely covers the first part and protects the electronic components in the receiving compartment, and an open state for inserting these electronic components into the receiving compartment.

[0010] The known solutions are particularly costly in terms of their design, both to ensure the required tightness of the receiving compartment, for example through hinge joints and other mechanical auxiliary solutions that normally serve as a guide for the mutual coupling between the two parts of the box body, and to ensure a complete and correct connection of the two locking parts, in particular by avoiding possible accidental misalignments that could impair the protective effect of the equipment.

[0011] Another disadvantage of the known solutions is that the two closure parts are manufactured by directly molding polyurethane material to withstand the pressure, temperature and humidity of the operation as well as the presence of cleaning agents, with production times and costs that negatively affect the production and administration costs of the known equipment.

[0012] Furthermore, polyurethane materials are predominantly opaque due to their composition, which essentially prevents inspection of the instrument's electronic components after the case body has been operatively closed.

[0013] Another disadvantage is that existing solutions use a box-like body with dimensions that are not always compatible with the cleaning chambers of commercially available cleaning devices, especially when the dimensions and internal volume are small. Therefore, their use may be limited and could be associated with potential drawbacks and operational delays in the cleaning process.

[0014] Therefore, there is a need to perfect protective equipment that can overcome at least one of the disadvantages of the previous technology.

[0015] The problem therefore arises of cleaning the invasive part of the medical instrument, which is inserted into the human body and can come into contact with water, without damaging the sensitive and expensive electronics.

[0016] In particular, an objective of the present invention is to realize protective equipment for cleaning medical instruments that can be manufactured cost-effectively and efficiently, that ensures the tightness of the receiving compartment and guarantees a complete and correct connection of the two closure parts, in particular by avoiding possible accidental misalignments that could impair the protective effectiveness of the equipment.

[0017] Another objective of the present invention is to realize protective equipment that can be essentially compatible with any type of cleaning chamber of commercially available cleaning equipment, especially when the dimensions and internal volume are small.

[0018] Another objective of the present invention is to realize protective equipment that enables effective inspection of the electronic components of the instrument even after the operational closure of the case body.

[0019] In order to eliminate the disadvantages of the prior art and to achieve these and other objectives and gain advantages, the applicant has developed, tested and implemented this invention. BRIEF SUMMARY OF THE INVENTION

[0020] This invention is set out and characterized in the independent claim. The dependent claims set out further features of this invention or embodiments of the main concept.

[0021] In accordance with the above-mentioned purposes and in order to solve the above-mentioned technical problem in a new way, also achieving significant advantages over the previous state of the art, protective equipment according to the present invention is used for cleaning endoscopic medical instruments, such as transesophageal probes or the like, with a hose section to be cleaned which contains electronic components to be protected at one end.

[0022] According to the present invention, the equipment comprises a closed, hydraulically sealed box body with an internally demarcated receiving compartment for housing the electronic components of the instrument in a state protected from the outside, wherein the tubular part can, for example, exit through a suitable opening.

[0023] The housing consists of a first base section for accommodating the electronic components to be protected and a second closure section configured to be selectively coupled to the first section. Specifically, the second section can be selectively positioned between a closed state in which the first section is completely covered, protecting the electronic components within the compartment, and a separate state in which the second section is spaced away from the first section or, in any case, separated, allowing access to the compartment.

[0024] According to one aspect of the present invention, the first part has a coupling edge with at least one unambiguous first coupling section. The second part also has a coupling edge configured such that it can be selectively coupled to the first coupling edge and has at least one second unambiguous coupling section configured such that it can be positively and unambiguously assigned to the first unambiguous coupling section, at least under the closing condition of the second part.

[0025] In this way, the two parts of the box body, base and closure, can be connected to each other or selectively separated, while maintaining a unique and correct relative positioning. In other words, the second part and the first part have one and only one possible mutual coupling, which is determined by the mutual design of the second unique coupling section with the first unique coupling section.

[0026] The solution according to the present invention thus makes it possible to completely separate the two parts of the box body, to handle them separately in their separate state, for example for storage or specific cleaning of the parts, and then to couple them unambiguously in the closed state for operation. This guarantee of unambiguous positioning makes it possible to eliminate at least the usual hinge joints and other mechanical auxiliary solutions that normally provide the mutual coupling between the two parts of the box body.

[0027] The protective equipment for cleaning medical instruments according to the present invention is thus both economical and efficient with regard to the complete and correct connection of the two closure parts to each other, in particular to avoid possible accidental misalignments that could impair the protective effect of the equipment.

[0028] Depending on the embodiment, the first part and the second part can be made of polymer material, in particular they can be produced by injection molding of polymer material. Such a solution is particularly advantageous and cost-effective, as it makes it possible to reduce production costs, increase productivity, and produce the required molds cost-effectively.

[0029] In this way, it is possible to leverage the economic and operational advantages of polymer injection molding to ensure the required mechanical and hydraulic strength properties of both parts of the housing, while simultaneously reducing manufacturing time and costs and increasing part productivity. Furthermore, by utilizing the intrinsic properties of injection molding, other auxiliary components such as inserts, handles, quick-release couplings for consolidating the coupling of the parts or for anchoring the electronic components of the medical instrument, or other components, can be molded in the same mold matrix along with one or both of the two housing parts.

[0030] Depending on the embodiment, the polymer material can be a transparent polymer with a transparency coefficient greater than 0.8. An optical polymer with transparency properties as described above can be used. The transparency coefficient is the ratio between the intensity of the radiation passing through the body and the total intensity of the radiation incident on the body; for example, in the case of glass, it is generally between 0.8 and 0.9. Such a solution is advantageous because the transparency allows for quick and easy inspection of the interior.

[0031] Examples of usable transparent polymers include polycarbonate, which is also particularly compatible with the cleaning conditions in the aforementioned cleaning device, or PMMA (polymethyl methacrylate).

[0032] The polymer material may optionally be a naturally opaque polymer or be made opaque to one and / or the other part of the first part and / or the second part.

[0033] It is therefore possible that one or the other part between the first and second parts consists of a transparent or opaque polymer, or a polymer made opaque. For example, the second part may be made of a transparent polymer to facilitate inspection, and the first part may be made of a transparent or matte polymer.

[0034] Exemplary embodiments can therefore be manufactured, at least in the aforementioned first part and optionally also in the second part, from a transparent polymer, for example polycarbonate or PMMA. Polycarbonate is advantageous in that, in addition to injection molding, it is a transparent polymer with near-glass transparency, with a transparency coefficient of 0.86 to 0.89; PMMA is also a transparent polymer with a transparency coefficient of 0.93, even higher than glass.

[0035] In accordance with other embodiments, at least the second part and optionally also the first part can consist of polyurethane material. Polyurethane material can also optionally be transparent.

[0036] Furthermore, the possibility of manufacturing one or both parts of the box body from transparent polymer material, e.g. polycarbonate or PMMA, offers effective control inspection of the instrument's electronic components, even after the box body has been operatively closed.

[0037] In accordance with a further aspect of the present invention, the first part and the second part comprise two long side walls and two short side walls defining a substantially square or rectangular basic shape. In this embodiment, both the first and the second distinct coupling section define a corresponding first and second chamfered section, respectively, which is maintained in continuity between a long side wall and the adjacent short side wall.

[0038] Advantageously, the first and second unique coupling sections define at least one corresponding second chamfered section in continuity between another of the long side walls and the adjacent short side wall. The second chamfered section is thus essentially opposite to the first chamfered section and defines a reduction in the diagonal of the box body, which may advantageously be smaller than the distance between the two short sides.

[0039] In this way, the box body can also be inserted into a cleaning device in the direction defined by the two beveled sections, reducing the space required compared to the two short sides. This advantageous solution makes it possible to make the protective equipment compatible with virtually any type of cleaning chamber of commercially available cleaning devices, especially when the dimensions and internal volume are small.

[0040] In accordance with advantageous embodiments of the equipment according to the present invention, at least one hydraulic sealing element can be provided which is associated with the box body and is configured for receiving the tubular part of the instrument outside the box body, also ensuring a hydraulic seal of the receiving compartment, thereby protecting the electronic components of the instrument.

[0041] Also advantageous are two sealing elements of the hydraulic sealing element, which together have a common through-bore designed for the passage of the tubular instrument part.

[0042] In some preferred solutions of the present invention, the first coupling edge and the second coupling edge each comprise a corresponding peripheral recess which is connected to the hydraulic sealing element for reception during operation. EXPLANATION OF THE DRAWINGS

[0043] These and other aspects, features and advantages of the present invention will become clear from the following description of an embodiment, which is to be understood as an example and not as a limitation, with reference to the accompanying drawings, wherein: - Fig. 1 shows a schematic representation of protective equipment in a closed state for cleaning endoscopic medical instruments such as transesophageal or similar probes; - Fig. 2 a schematic representation of the protective equipment Fig. 1 shows in a separate state; - Fig. 3 a schematic representation of a top view of the protective equipment made of Fig. 1 shows; - Fig. 4 a schematic representation of a front view of the protective equipment Fig. 1 shows; - Fig. 5 a schematic representation of a top view of a first detail of the protective equipment Fig. 1 shows; and - Fig. 6 a schematic representation of a top view of a second detail of the protective equipment Fig. 1 shows.

[0044] It should be noted that the expressions and terms used in this description, as well as the figures in the accompanying drawings, are only intended to better illustrate and explain this invention, as they serve as a non-limiting example of the invention, the scope of protection being defined by the patent claims.

[0045] For clarity, identical reference numbers have been used wherever possible to identify common, identical elements in the figures. It is understood that elements and features of one embodiment may be conveniently combined or integrated into other embodiments without further specification. DESCRIPTION OF THE EXECUTION FORMS

[0046] With reference to the accompanying figures, equipment 10 according to the present invention can be used to protect an endoscopic medical instrument—only partially shown here in hatching and designated by reference numeral 100—such as a transesophageal probe, and in particular its electronic components 110, while enabling the cleaning, thermal disinfection, and drying of its tubular parts or the insertion tube 120. These processes are generally carried out within a cleaning chamber of a special cleaning device (only partially shown in the accompanying figures). Fig. 3 schematically depicted and generally designated with the reference number 200). This makes equipment 10 usable as a safety container for the protected handling of endoscopic devices or instruments.

[0047] The present equipment 10 of this invention comprises a box body or collection body 11, which can be opened and closed as described in more detail below and defines a receiving compartment 12. This box body 11 is hydraulically sealed in the closed state and internally defines the receiving compartment 12 in order to accommodate, in a state protected from the outside, the electronic components 110 of the aforementioned instrument 100, which typically cannot be separated from the insertion tube 120 of the instrument 100 to be cleaned.

[0048] The box body 11 consists of at least two interconnected parts, of which a first or lower part, the bottom 13, serves to hold the part of the electronic components 110 to be protected and a second or upper part, 14, serves as the closure.

[0049] The first part 13 and the second part 14 can be designed as symmetrically arranged, form-fitting shells.

[0050] In particular, the first part 13 and the second part 14 can be selectively combined with each other in a closed state, wherein the second part 14 completely covers the first part 13 by enclosing the electronic components 110 in the receiving compartment 12 ( Fig. 1) protects, and in a separate, in particular spaced-apart state, in which the box body 11 is open and thus access to the receiving compartment 12 ( Fig. 2) for the insertion of the electronic components 110 together with the insertion tube 120 of the instrument 100 to be cleaned. In particular, the first part 13 and the second part 14 can be separated and spaced apart from each other by a simple linear displacement, without the need for rotation and thus without the need for mutual hinge means, which further reduces manufacturing costs. In fact, when separated, the first part 13 and the second part 14 are completely separated from each other.

[0051] The first part 13 and the second part 14 can be defined by corresponding pairs of short side walls 15a, 16a and long side walls 15b, 16b and their base walls 17, 18, which serve here as bottom and top walls respectively ( Fig. 5 and Fig. 6).

[0052] The entirety of the short side walls 15a and the long side walls 15b of the first part 13 defines a lower coupling edge 19, which also defines at least one first unique coupling section 21, here two opposing sections. In the embodiment shown in the accompanying figures, each first unique coupling section 21 is realized in a corresponding chamfered section 23, which is maintained in continuity between the respective short side walls 15a and long side walls 15b.

[0053] Similarly, the entirety of the short side walls 16a and the long side walls 16b of the second part 14 defines, essentially in a mirror-image fashion, an upper coupling edge 20, which defines two opposing second unique coupling sections 22. In the embodiment shown in the accompanying figures, each second unique coupling section 22 is realized in a corresponding chamfered section 24, which is maintained in continuity between the respective short and long side walls 16a and 16b, respectively.

[0054] According to an embodiment described with reference to the accompanying drawings, the box body 11 has the shape of a small portable case, and the first part 13 and the second part 14, which, as mentioned, can be designed as symmetrically arranged, form-fitting shells, can include a corresponding half-handle 25a and 25b, respectively, which projects from the corresponding long side walls 15b and 16b and defines a complete handle 25 when the two parts 13 and 14 are closed. Alternatively, a handle 25 could be provided on the top of the second part 14.

[0055] According to the invention, the first part 13 and the second part 14 are manufactured from injection-molded polymer, for example using a common mold. Such a solution is efficient, economical, highly productive, and reliable.

[0056] The polymer material used for the first part 13 and the second part 14 can be of the same type or different. For example, a transparent polymer material can be used for both the first part 13 and the second part 14. Alternatively, an opaque or frosted polymer material can be used for the first part 13 and, if applicable, for the second part 14; consequently, this material can consist of either a transparent or an opaque or frosted polymer material.

[0057] In particular, a polymer material can be used, which, for example, could be a transparent polymer with a transparency coefficient greater than 0.8. For instance, an optical polymer such as polycarbonate, which is also particularly suitable for the cleaning conditions of the cleaning device in question, or PMMA could be used. Alternatively, a polyurethane-based polymer material could also be used; this, too, can be either transparent or opaque.

[0058] In one example, the second part 14 and, if applicable, also the first part 13 can be manufactured by injection molding from transparent polymer, for example polycarbonate or PMMA, in order to use the transparency to allow visual inspection of the receiving compartment 12 even when the two parts 13 and 14 of the box body 11 are closed.

[0059] If necessary, the first part 13 can be made of transparent polymer material, for example from those mentioned above, or of opaque injection-molded polymer material.

[0060] Various embodiments can be combined. In one example, the first part 13 can be made of naturally opaque or made opaque polymer material, and the second part 14 of transparent polymer material. For example, the first part 13 could be made of polyurethane or opaque polycarbonate, and the second part 14 of a transparent polymer, such as polycarbonate or PMMA. A specific example is the use of transparent polycarbonate at least for the second part 14. In another example, both the first part 13 and the second part 14 are made of a transparent polymer, for example, both of polycarbonate or PMMA. Those skilled in the art can provide further examples by combining the type of polymers and the transparency and opacity properties as needed to produce the first part 13 and the second part 14 by injection molding.

[0061] According to the embodiments described with reference to the accompanying drawings, a circumferential seal 26 is associated with the lower edge 19. This seal is made of silicone, elastomer, or a similar material and is suitable for providing a hydraulic seal. The circumferential seal 26 is shaped such that, when the two parts 13 and 14 of the box body 11 are closed, it is tightly coupled to the upper edge 20.

[0062] Furthermore, the box body 11 is provided with four sealing hooks, generally designated by reference number 27, which traditionally consist of a lever system attached to the long walls 15b of the first part 13 and designed for selective engagement with the corresponding recesses of the devices on the long walls 16b of the second part 14. The dimensions, shape, and mutual radii of rotation of the lever system, as well as the specific position of the hook recesses, ensure a desired coupling tension defined by the sealing hooks 27 when the two parts 13 and 14 are closed, in order to bring the circumferential seal 26 into optimal sealing condition.

[0063] It is self-evident that instead of the four described sealing hooks, other solutions may be provided, for example screw, spring, grid or other solutions suitable to ensure the intended mutual closing tension of the two parts 13 and 14 of the box body 11.

[0064] In addition, some embodiments may include support feet 28 connected to the first part 13, which serves as a support base for the equipment 10, and positioning molded parts 29 that enable a clear and targeted positioning of the instrument 100 to be cleaned.

[0065] The box body 11 further comprises an opening 30, which in this case is defined by a lower recess 30a at the lower edge 19 of the first part 13 and a corresponding upper recess 30b at the upper edge 20 of the second part 14. A hydraulic sealing element 31 is associated with the opening 30, which is configured to receive the tubular part 120 of the instrument 100 and allows this part to exit the box body 11 in a sealed manner.

[0066] The hydraulic sealing element 31 comprises a first sealing element 31a, which is associated with the recess 30a of the lower edge 19, and a second sealing element 31b, which is associated with the recess 30b of the upper edge 20a. In their coupled state, the first and second sealing elements 31a and 31b define a through-bore 32 through which the tubular part 120 of the instrument 100 passes.

[0067] For example, due to the requirements of the instrument 100 and / or the cleaning processes, it is possible to provide further openings in the housing 11 for the passage of additional tubular parts 120, as well as external probes, supply or control components, or the like. These alternative solutions always include corresponding hydraulic sealing elements designed and constructed to protect the receiving compartment 12 from the ingress of water or, more generally, from moisture, in order to protect the electronic components 110 of the instrument 100.

[0068] Obviously, changes can be made and / or parts added to the equipment described so far without deviating from the scope of the present invention as defined by the claims.

[0069] Although this invention has been described with reference to some specific embodiments, it is obvious that those skilled in the art can realize other equivalent forms of protective equipment for cleaning medical endoscopic instruments, such as transesophageal probes or the like, which have the features set out in the claims and thus all fall within the scope of protection defined therein.

[0070] In the following patent claims, the reference numerals given in parentheses serve only for better understanding and should not be regarded as limiting factors of the scope of protection defined by the patent claims.

Claims

[1] Protective equipment (10) for cleaning medical endoscopic instruments (100), such as transesophageal probes or the like, comprising a tubular part (120) to be cleaned, which contains electronic components (110) to be protected at one end, including a hydraulically sealed box body (11) which internally defines a receiving compartment (12) to house the electronic components (110) in a state protected from the outside, wherein the box body (11) comprises a first bottom part (13) to house the electronic components (110) and a second closing part (14) configured to be selectively coupled with the first part (13) between a closed state in which the second part (14) completely covers the first part (13) and protects the electronic components (110) in the receiving compartment (12), and a separate state,in which the second part (14) is separated from the first part (13) and allows access to the intake compartment (12), , characterized by , that the first part (13) comprises a first coupling edge (19) having at least one first unique coupling section (21) and that the second part (14) comprises a second coupling edge (20) configured to be selectively coupled to that first coupling edge (19) and having at least one second unique coupling section (22) configured to be symmetrically arranged, positively interlocking and uniquely associated with the first unique coupling section (21). [2] Equipment (10) according to claim 1, characterized by that the first part (13) and the second part (14) are manufactured from polymer material using injection molding. [3] Equipment (10) according to claim 1 or 2, characterized by, that the polymer material is transparent, in particular has a transparency coefficient greater than 0.8, at least for this second part (14) and, if applicable, also for this first part (13). [4] Equipment (10) according to claim 3, characterized by that the transparent polymer material is an optical polymer. [5] Equipment (10) according to claim 2, 3 or 4, characterized by , that the first part (13) is made of a transparent polymer, in particular polycarbonate or PMMA or of opaque injection-molded polymer material. [6] Equipment (10) according to any one of claims 2 to 5, characterized by , that the second part (14) is made of a transparent polymer, in particular polycarbonate or PMMA. [7] Equipment (10) according to any of the preceding claims, wherein the first part (13) and the second part (14) each comprise a pair of long side walls (15b, 16b) and a pair of short side walls (15a, 16a), characterized by , that each of the first and second unique coupling sections (21, 22) defines at least one corresponding first chamfered section (23, 24) in continuity between one of the long side walls (15b, 16b) and an adjacent short side wall (15a, 16a). [8] Equipment (10) according to claim 7, characterized by , that each of the first and second unique coupling sections (21, 22) defines at least one corresponding second chamfered section (23, 24) in continuity between another of the long side walls (15b, 16b) and an adjacent short side wall (15a, 16a). [9] Equipment according to any of the preceding claims, characterized by, that it comprises at least one hydraulic sealing element (31) associated with the box body (11) and configured to allow the receiving of the said tubular part (120) of the instrument (100) outside the said box body (11). [10] Equipment according to claim 9, characterized by , that the hydraulic sealing element (31) comprises a first sealing element (31a) associated with the first coupling edge (19) and a second sealing element (31b) associated with the second coupling edge (20), wherein the first sealing element (31a) and the second sealing element (31b) together define a through-hole (32) configured for the passage of the tubular part (120) of the instrument (100). [11] Equipment according to claim 9 or 10, characterized by, that the first coupling edge (19) and the second coupling edge (20) each comprise a corresponding circumferential recess (30a, 30b) which is designed to jointly define at least one positively locking opening (30) arranged symmetrically with the hydraulic sealing element (31).

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