Medical device for personal hygiene after defecation

Abstract

The present invention relates to the medical field and in particular to a medical and portable device for personal hygiene after defecation. The device (1, 1', 1'', 1''') comprises: - a scoop or paddle with a first proximal portion (10, 10', 10'', 10''') of support and handgrip (12) configured as an ergonomic handle and a second distal functionally independent portion (14, 14', 14'', 14''') configured for cleaning; - at least one convex relief (15) similar to a cushion on said second cleaning distal portion (14); - and wherein the material which the second cleaning distal portion (14, 14', 14'', 14''') is made of is softer than the material of the first proximal portion (10, 10', 10'', 10''') of support and handgrip (12) of the scoop or paddle, thus implementing a mechanical cleaning action similar to that exerted by a bovine tongue.

Description

[0001] Title: Medical device for personal hygiene after defecation DESCRIPTION

[0002] Field of application

[0003] The present invention relates to a portable medical device for personal hygiene after defecation.

[0004] The present invention falls within the technical field of medical devices for personal hygiene, specifically in the field of portable tools for cleaning after defecation. The device that is the subject matter of the invention represents an innovative solution in the field of intimate hygiene aids, characterized by specific structural and functional properties that distinguish it from traditional methods currently available on the market.

[0005] The device can be configured as a Class I medical system according to the classification of Directive 93 / 42 / EEC on medical devices, intended for external use for the cleaning and hygiene of perianal areas. The technical classification of the device falls within the category of reusable tools for personal hygiene, with possible single-use variants for specific applications. Still more particularly, but not exclusively, the invention relates to a reusable and sanitizable device that can be made available in a home toilette or transported in a hygienic container. As an alternative, the device of the invention may also be of the single-use type.

[0006] Prior art

[0007] As it is well known, in this specific technical field significant technical shortcomings may be detected in the methods currently available for hygiene after defecation. The traditional toilet paper, although being the globally most popular method, has intrinsic structural limitations jeopardising the cleaning efficiency. From the technical point of view, the toilet paper consists of cellulose fibres with a porous structure which, although absorbing liquids, does not ensure an effective mechanical removal of solid residues. The tensile strength of toilet paper is insufficient to exert a controlled and uniform pressure on the surface to be cleaned. Moreover, the environmental impact of toilet paper production, which has an unfavourable ratio between resources used and duration of use, represents an increasingly important technical problem.

[0008] On the contrary, traditional bidet systems, widely used in southern Europe, have limitations related to the need for fixed infrastructures and to the inability to precisely control the pressure and direction of the water jet which is sometimes excessive for a gentle application on the perianal area,particularly if pathological conditions such as haemorrhoids or anal fissures are present.

[0009] The electronic devices integrated in WCs, mainly of Japanese origin, although offering advanced functionality, have high costs (typically more than one thousand euros per unit) and a maintenance complexity which limit the diffusion thereof. Moreover, these systems do not allow a direct tactile control of the cleaning action, exclusively relying on the action of pressurized water.

[0010] Finally, wet wipes, increasingly used as an alternative to toilet paper, have significant environmental problems related to their composition of non-biodegradable materials and to the presence of chemical preservatives which can cause allergic reactions. From the technical point of view, the unwoven textile structure thereof does not ensure an effective mechanical action of removing residues.

[0011] It should also be noted that from the healthcare point of view, the inadequacy of traditional methods for cleaning after defecation significantly contributes to the occurrence and worsening of anorectal diseases. Haemorrhoids, which according to epidemiological studies affect about 40-50% of adult population in industrialized countries, are often exacerbated by inadequate hygiene practises which involve repeated microtrauma to the anal mucosa.

[0012] The presence of faecal residues, even microscopic ones, in the perianal area promotes bacterial proliferation and can cause urinary tract infections, particularly in women, where the anatomical proximity between the anus and the urethral meatus increases the risk of cross-contamination. Microbiological studies have shown that the bacterial load in the perianal area can remain significantly high even after cleaning with traditional toilet paper

[0013] In view of the above considerations there is certainly a need for a more convenient, comfortable, safe and clean method for personal hygiene after defecation.

[0014] As seen above, current devices for anus cleaning after defecation have all several drawbacks which make them uncomfortable, expensive or anyway ineffective, facilitating the diffusion of pathogens.

[0015] For instance, a known solution is disclosed in an old patent document No. US 1,818,388 relating to a cleaning device adapted to be connected to a source of water under pressure. The cleaning head 6 of this device has a plurality of projections 29 each provided with a perforation 31 allowing the water flow.This solution has been conceived for working in cooperation with a water source only.

[0016] Another known solution is disclosed in a PCT patent application No. WO 00 / 38563 relating to a hand-held appliance for use when cleaning the perineal area of the body. This tool has been specifically conceived for a person having inability or limited range of motion. The tool has a curved handle and an extended cleaning head provided with a flexible structure for temporarily gripping toilet paper.

[0017] This solution has the same drawbacks of the regular use of toilet paper, and it is not useful for efficiently remove faecal residues.

[0018] A similar support for toilet paper having a cleaning portion shaped as a hand is disclosed in the US patent application No. US 2003 / 0016008 Al. A further known solution is reported in the PCT application No. WO 2012 / 144596 Al disclosing a tongue cleaning tool for animals including a scoop or paddle with a first proximal handgrip portion and a second distal portion configured for cleaning. However, this tool cannot be imagined for a different purpose since the cleaning distal portion has sharped projection that are incompatible with the cleaning of a perineal area of the human body.

[0019] The technical problem underlying the present invention is to devise a new and more effective device for personal hygiene after defecation which has such structural and functional features of ease of use, effectiveness of action and environmental sustainability as to overcome the drawbacks complained of with reference to the devices and practices currently in use.

[0020] Summary of the invention

[0021] The solution idea underlying the present invention is to provide a portable tool for personal cleaning that can allow a gentle rubbing action of the anal region to be simulated and can reach every point without aggression.

[0022] Based on said solution idea, the technical problem is solved by a device for personal hygiene after defecation comprising:

[0023] - a scoop or paddle with a first proximal support and handgrip portion configured as an ergonomic handle and a second distal functionally independent portion configured for cleaning;

[0024] - at least one convex relief similar to a cushion on the second cleaning distal portion;

[0025] - and wherein the material which said second cleaning distal portion is made of is softer than the material of the first proximal support andhandgrip portion of the scoop or paddle, thus implementing a soft mechanical cleaning action.

[0026] The present invention solves the technical problems identified in the prior art through a portable device for personal hygiene after defecation characterised by an innovative structural configuration that combines biomimetic principles with technologically advanced materials. The fundamental technical principle can be considered as based on the controlled replication of the mechanical cleaning action similar to that exerted by the bovine tongue which is characterised by a surface provided with horny papillae which ensure an effective but gentle removal action. The device according to the invention implements a biomimetic principle through a structure with calibrated convex reliefs, made of a silicone material with a hardness (Shore A) comprised for example in a range of 20-40, which allows an optimal specific pressure to be exerted on the perianal area, comprise for example between 0, 1-0,5 N / cm2, which is sufficient for the mechanical removal of residues but lower than the tissue damage threshold.

[0027] Advantageously, an antioxidant vitamin E filler is added to the silicone material.

[0028] Other detailed and non-limiting features of the invention are summarised below.

[0029] For example, advantageously, the second cleaning distal portion has the shape of a simple leaf.

[0030] More particularly, the shape of the second cleaning distal portion is substantially that of two ellipses partially overlapping and with aligned major axis.

[0031] The second cleaning distal portion has a plurality of small peripheral reliefs surrounding the convex relief.

[0032] More particularly, in a preferred embodiment, there are at least two convex reliefs formed each in the area of a respective elliptical shape.

[0033] In another embodiment of the present invention the convex reliefs are at least three.

[0034] Said convex reliefs are aligned along the major axis of symmetry of the device and are configured for a soft cleaning action with a deep and targeted massage.

[0035] The central convex relief is more protruding than the other adjacent reliefs.In order of size the central relief is the largest, the most distal relief is the second in size and the proximal relief is the smallest.

[0036] The small peripheral reliefs surround the convex reliefs aligned along the axis of symmetry. Said small peripheral reliefs are shaped as narrow and elongated small leaves. As an alternative, said small peripheral reliefs are drop-shaped.

[0037] The peripheral reliefs mainly serve as a final finishing with a particularly gentle action.

[0038] Obviously, a person skilled in the art understands that other relief configurations can be adopted in number, shape and size as needed.

[0039] For example, as shown in Figure 3, the largest-sized relief is the distal one while the two reliefs aligned along the axis of symmetry have the same smaller size.

[0040] Advantageously, the material which the second cleaning distal portion is made of is a synthetic plastic material of the soft silicone type. Moreover, an antioxidant vitamin E filler is added to the silicone material.

[0041] As an alternative, a substance based on silver or silver salts, such as AgNO3or silver sulfadiazine, may be added to the material forming the distal cleaning portion.

[0042] Said second cleaning distal portion can be made integral with the support scoop or paddle portion or can be structurally independent and, in that case, overlapping and bound to the support scoop or paddle.

[0043] In a further embodiment the whole scoop or paddle is slightly arched so that the upper portion of the convex relief is more projecting

[0044] The material which the scoop or paddle is made of is waterproof since the device is intended to be rinsed with running water.

[0045] Further features and advantages of the present invention will be apparent from the following description of an exemplary embodiment thereof given by way of non-limiting example with reference to the attached drawings.

[0046] Brief description of the drawings

[0047] - Figure 1 shows a perspective view of the device for personal hygiene after defecation manufactured according to the present disclosure;

[0048] - Figure 2 shows another perspective view of the device according to the present disclosure in an alternative embodiment thereof;- Figure 3 shows a further perspective view of the device according to the present disclosure in an alternative embodiment thereof;

[0049] - Figure 4 shows an exploded perspective view of the device according to the present disclosure;

[0050] - Figure 5 shows a vertical elevational side view of the device of Figure 1 ; - Figure 6 shows an enlarged-scale detail of a portion of the device for personal hygiene according to the present disclosure;

[0051] - Figure 7 shows a schematic perspective view of an alternative embodiment of the device of Figure 3;

[0052] - Figure 8 shows a schematic perspective view of a further alternative embodiment of the device according to the invention.

[0053] Detailed description

[0054] With reference to the attached drawings, for example in Figure 3, a device manufactured according to the present disclosure for personal hygiene after defecation is globally and schematically indicated with 1.

[0055] The device 1 has an optimised structural configuration that integrates biomechanical engineering principles with advanced materials technologies. Said general structure of the device comprises two main components that are functionally distinct but structurally integrated.

[0056] More particularly, the device 1 comprises a main structure essentially including a support element 10 and a functionally independent cleaning portion 14.

[0057] The support element 10 is configured and structured as a support scoop or paddle made for example of a rigid polymeric material. Always by way of example, a suitable material for this purpose is preferably polypropylene (PP) or acrylonitrile-butadiene-styrene (ABS), with an elastic modulus comprised between 1,500 and 3,000 MPa.

[0058] The support element 10 has a first proximal portion 12 configured as an ergonomic handle, with a length comprised for example between 80 and 120 mm and a grip diameter comprised between 15 and 25 mm, designed according to ergonomic principles to ensure a firm and comfortable grip. Said first proximal portion 12 represents the control and handling element of the device 1. Said portion is made of a high mechanical strength polymeric material, preferably isotactic polypropylene with a molecular weight comprised between 300,000 and 500,000 g / mol, which ensures a high flexural strength (elastic modulus 1,300-1,800 MPa) and an excellent chemical resistance to disinfectants.The handgrip geometry follows established ergonomic principles, with an elliptical cross-section measuring 18x22 mm that perfectly adapts to the digital grip. The handgrip surface has a micro-texture with a roughness Ra comprised between 1,5 and 2,5 pm, obtained by controlled sandblasting, which ensures a secure grip even in the presence of moisture without causing skin irritations.

[0059] The proximal portion incorporates a tactile identification system consisting of micro-reliefs arranged according to a specific pattern that allows the correct orientation of the device even in conditions of poor visibility. These identification elements, with a height of 0.5- 1.0 mm, are positioned 25-30 mm from the proximal end 6 to coincide with the thumb rest area during the standard grip.

[0060] The transition between the proximal portion and the distal portion is characterised by a connection area 13 with a radius of curvature of 8-12 mm which eliminates stress concentrations and facilitates device cleaning. This transition area has a reduced thickness (4-6 mm) with respect to the adjacent sections to ensure a controlled flexibility in use.

[0061] The cleaning portion 14 is in fact a distal portion of the device 1 specifically structured and configured to perform the cleaning action.

[0062] It represents the main functional element of the device, 1 and has been specifically designed for the cleaning action the perianal area. The geometric configuration of this portion results from an in-depth biomechanical analysis of the anatomy of the anorectal region and of the optimal contact dynamics for removing organic residues.

[0063] The total length of the device 1 is comprised between 200 and 280 mm, a size optimised through ergonomic studies to ensure a precise control in use while maintaining a hygienic safety distance. The total weight of the device is comprised between 25 and 45 grams, distributed according to a 60:40 mass ratio between the proximal portion and the distal portion to ensure an optimal balance in use.

[0064] Advantageously, the cleaning portion 14 is characterized by a simple leafshaped geometry obtained by the intersection of two partially overlapping ellipses with aligned major axes, that is: a bi-elliptical configuration. In essence, the shape of the cleaning distal portion 14 is that of a pair of ellipses 21, 22 partially overlapping along the major axis of symmetry X thereof. In an alternative embodiment the proximal ellipse 21 may be arranged and aligned with its own minor axis to the major axis of the distal ellipse 22.The dimensions of the distal portion 14 are optimized for the anatomy of the perianal area, with a total length comprised for example between 100 and 180 mm and a maximum width comprised for example between 35 and 80 mm.

[0065] The proximal ellipse has a semi-axial size of about 30x50 mm, while the distal ellipse has a size of about 50x70 mm. The overlap between the two ellipses is of at least 8-20 mm, creating an overall shape with a length being equal to 90% of the cleaning distal portion 14.

[0066] The thickness of the cleaning distal portion 14 varies according to an optimised profile: 3-4 mm in the central area to ensure a structural rigidity, reducing to 1-2 mm towards the peripheral edges to ensure flexibility and adaptability to anatomical irregularities. This variation in thickness is achieved through injection moulding techniques with a precise control of temperature profile.

[0067] Advantageously, at least one convex relief 15 similar to a cushion or a hill is provided on the second cleaning distal portion 14, as clearly shown in Figure 3.

[0068] Moreover, the material which the second cleaning distal portion 14 is made of is softer than the material of the scoop-or-paddle-shaped support element 10.

[0069] More particularly, the device 1 implements a controlled hardness gradient between the support portion 10 and the cleaning portion 14. While the support element 10 and the cleaning portion 14. Mentre the support element 10 maintains a high rigidity to ensure the directional control, the distal portion 14 has a significantly lower hardness, for example, their ratio can be selected between the values Shore A 20-40 of the cleaning portion 14 and Shore D 70-80 of the support element.

[0070] Returning now to the convex relief 15 provided on the cleaning distal portion 14, it should be noted that there are also multiple small peripheral reliefs 30 surrounding the convex relief 15.

[0071] More particularly, in an alternative embodiment 1’, shown in Figure 2, there are at least two convex adjacent reliefs 16, 18 made each in the area of a respective elliptical shape 21, 22 of the cleaning portion 14’.

[0072] Moreover, in a further embodiment, shown with the numeral 1” in Figure 1, the device according to the present disclosure provides at least three convex reliefs 16, 18 and 20 in the cleaning portion 14”.

[0073] As in the case of the single relief 15 of Figure 3, the convex reliefs 16, 18, 20 integrated in the cleaning distal portion 14 of the example of Figure 1have been devised according to biomimetic principles that replicate the mechanical action of the horny papillae which are present on a bovine tongue.

[0074] Said convex reliefs 16, 18 and 20 are aligned along the major axis of symmetry X of the device 1

[0075] Said convex reliefs 16, 18, 20, aligned along the longitudinal axis X of the device, have each a height comprised at least between 2 and 8 mm and a radius of curvature comprised at least between 15 and 25 mm. The configuration of the reliefs is designed to ensure a progressive and controlled contact with the surface to be cleaned.

[0076] The heights or surface projections of the reliefs are different from each other. For example, the convex distal relief 20 may be more protruding or projecting than the other adjacent reliefs 16 and 18.

[0077] In order of size the distal relief 20 is the largest, the central relief 18 is the second in size and the proximal relief 16 is the smallest.

[0078] More in detail, the convex distal relief 20 is the largest-sized element of the system, with a base diameter comprised between 10 and 24 mm and a height of 5-8 mm. The geometry of the relief follows a parabolic profile with a variable radius of curvature: 6-8 mm in the apical area to ensure a gentle contact, progressively increasing up to 12-15 mm in the basal area to ensure a structural stability.

[0079] The position of the central relief 18 is optimised to coincide with the geometric centre of the contact area during the normal use of the device. Finite element analyses confirmed that this position ensures the most uniform distribution of contact stresses, minimising localised pressure peaks.

[0080] The second convex relief 18 is positioned in the central area of the cleaning portion, at a distance of 15-18 mm from the distal relief. Its dimensions are intermediate with respect to the other elements: base diameter 8-21 mm and height 3-5 mm. The geometry follows an ellipsoidal profile with an axial ratio of 1,2:1, oriented along the longitudinal axis of the device.

[0081] Said central relief 18 has the specific function of completing the cleaning action in the most distal area of the perianal area, ensuring a complete coverage without requiring complex movements in use. The reduced height thereof with respect to the distal relief prevents excessive pressures in an anatomically more sensitive area.

[0082] The third convex relief 16, positioned in the proximal area 12-15 mm from the central relief 18, has the smallest dimensions of the system: basediameter 6-19 mm and height 2-4 mm. Its function complements the other elements 18 and 20, providing a finishing action and ensuring a gradual transition between the active cleaning area and the support portion.

[0083] The geometry of this relief follows a spherical profile with a constant radius of curvature of 4-6 mm, optimised for a gentle cleaning completion action. Its position is calculated to ensure an optimal contact during the final step of the cleaning movement.

[0084] The cleaning system is completed by a series of micro-peripheral reliefs 30 distributed along the periphery or contour of the cleaning distal portion 14. Said elements 30, typically measuring 2-4 mm in length, 1-2 mm in width and 0,5- 1,5 mm in height, have the specific function of final finishing and peripheral sealing during the cleaning action.

[0085] Said small peripheral reliefs 30 surround the convex reliefs 16, 18 or 20 aligned along the axis of symmetry X and are shaped as narrow and elongated small leaves. As an alternative, said small peripheral reliefs are drop-shaped. The small reliefs 30 can also have a different shape and size from each other.

[0086] The shape of the micro-reliefs 30 can vary according to two main configurations: teardrop shape for the maximum effectiveness in removing liquid residues, or an elongated small leaf shape for a gentler action. The distribution of the micro-reliefs follows a pattern designed to ensure a uniform coverage: a density of 8-12 elements per linear centimetre of perimeter, with a regular spacing of 0.8- 1.2 mm, as clearly shown in Figure 6.

[0087] Each micro-relief 30 is oriented at a specific angle with respect to the local tangent of the perimeter, calculated to optimise the action of conveying residues towards the outside of the contact area. This orientation gradually varies along the perimeter, from 15° in the distal zone to 25° in the proximal zone.

[0088] From the above description, it is evident that, as a whole, the surface of the cleaning distal portion 14 is similar to the microstructure of the papillae of the bovine tongue according to a pattern optimised to maximise the cleaning effectiveness while minimising the surface friction.

[0089] Obviously, a person skilled in the art understands that other relief configurations can be adopted in number, shape and size as needed.

[0090] For example, as shown in Figure 6, the three reliefs 16, 18 and 20 aligned along the axis of symmetry have the same size.It should also be noted that the silicone material of the cleaning distal portion 14 is formulated with anti-adhesive additives that reduce the surface tension to values below 25 mN / m, preventing the adhesion of organic residues and facilitating the cleaning and sanitisation operations of the device 1. Moreover, advantageously, an antioxidant vitamin E filler is added to the silicone material.

[0091] Moreover, a substance based on silver or silver salts, such as AgNO3or silver sulfadiazine, may be added to the material forming the distal cleaning portion 14.

[0092] Preferably, the cleaning distal portion 14 is made of medical-grade silicone elastomer, specifically formulated for applications in contact with sensitive mucosae. The base material consists of polydimethylsiloxane (PDMS) with a controlled molecular weight comprised between 100,000 and 300,000 g / mol, cross-linked through a platinum vulcanisation system which ensures the absence of toxic by-products.

[0093] The mechanical properties of the material are optimised for the specific application: Shore A hardness comprised between 25 and 35, elongation at break being higher than 400%, resistance to tear being higher than 25 N / mm according to ISO 34- 1 standard. These features ensure the necessary flexibility to adapt to anatomical irregularities while maintaining the mechanical strength required for a repeated use.

[0094] The silicone formulation incorporates specific additives to give anti-adhesive properties: surface tension reduced to 22-25 mN / m through the addition of functionalised silicones in a concentration of 2-5% in weight. This feature prevents the adhesion of organic residues and significantly facilitates cleaning operations after use.

[0095] The surface properties are further optimised through a low-temperature plasma treatment that creates a surface microstructure with controlled roughness Ra = 0.8- 1.2 pm. This roughness is optimal for ensuring an effective cleaning action without causing microtrauma to the anal mucosa. The integration between the rigid proximal portion 10 and the flexible distal portion 14 can be achieved using two main technical methods, each with specific application advantages.

[0096] In a first embodiment the whole device 1 is manufactured through a bimaterial moulding process (bi-injection moulding) that allows the complete structural integration of the two components in a single production cycle. This process uses a sequential mould in which the rigid portion 10 is moulded first, followed by the injection of the silicone material that chemically bonds to the prepared surface of the rigid portion.The interface area between the two materials is designed with a mechanical interlocking geometry, as shown by way of example in Figures 4 and 6, which may or may not incorporate a constraint of the chemical / physical type, that is an adhesive or Velcro. The surface of the rigid portion in the interface area has a series of undercuts with a depth of 0.5- 1.0 mm that are filled with silicone during the injection, creating an irreversible mechanical anchorage.

[0097] In an alternative embodiment the distal portion 14 is made as a separate and removable component (Figures 4 and 6) which is subsequently assembled to the proximal portion through a mechanical connection system. This approach allows the device to be customised by replacing the distal portion with specific variants for different applications.

[0098] The connection system is based on a conical coupling with an angle of 6-8°, which ensures a precise positioning and a stable connection. The distal portion has a rigid overmoulded polypropylene insert that couples with the conical seat of the proximal portion. A snap-lock system prevents an accidental disconnection in use.

[0099] It is also worth pointing out that in the alternative embodiment of Figure 7 the cleaning distal portion, indicated as 14’, is similar to that of Figure 3 with a single convex relief 15 but extended and elongated towards the handgrip region 12 of the support 10.

[0100] Depending on the different physical embodiments, the device 1 according to the present disclosure may lend itself to be configured for different applications of use which will be illustrated below as if they were different types of embodiments.

[0101] First embodiment

[0102] The first preferred embodiment of the device 1 according to the invention represents the standard configuration optimised for everyday domestic use. This variant, illustrated in Figures 1, 2 or 3 of the drawings, incorporates all the fundamental technical features in a balanced configuration between functional effectiveness and simplicity of construction.

[0103] The device in the standard configuration has a total length of 175 mm, divided into 85 mm per for handgrip proximal portion and 90 mm for the cleaning distal portion. These proportions, resulting from ergonomic studies on a sample of multiple users, ensure the optimal control in use while maintaining dimensions which are compatible with portability.

[0104] The distal portion has a characteristic bi-elliptical shape with a length of 55 mm and a maximum width of 30 mm. The geometry is defined by two ellipses with specific parameters: proximal ellipse with semi-axes ai=17 mmand bi=l l mm, distal ellipse with semi-axes a2=20 mm and b2=14 mm, overlap of 9 mm. This geometric configuration has been optimised through numerical simulations to ensure the maximum effective contact area.

[0105] This first configuration implements a system with three convex reliefs aligned along the longitudinal axis of the device. The central relief 18 has a base diameter of 12 mm and a height of 6.5 mm, with a parabolic profile characterised by an apical radius of curvature of 7 mm. The distal relief 20 has a diameter of 9.5 mm and a height of 4 mm, while the proximal relief 16 has a diameter of 7.5 mm and a height of 3 mm.

[0106] The spacing between the reliefs is optimised for the average anatomy of the perianal area: 16 mm between the central and distal reliefs, 14 mm between the central and proximal reliefs. This distribution ensures an optimal simultaneous contact during the standard cleaning action, minimising the number of passes required.

[0107] The peripheral system comprises at least twenty-eight drop-shaped microreliefs 30 evenly distributed along the contour of the distal portion. Each micro-relief has a length of 3 mm, a maximum width of 1.5 mm and a height of 1 mm. The orientation varies from 18° in the distal area to 22° in the proximal area with respect to the local tangent.

[0108] The proximal portion is made of isotactic polypropylene with an MFI (Melt Flow Index) of 12 g / lOmin (230°C, 2.16 kg), which ensures an excellent processability and a dimensional stability. The distal portion uses LSR (Liquid Silicone Rubber) medical silicone with a Shore A hardness of 30, an elongation at break of 450%, a resistance to tear of 28 N / mm.

[0109] Second embodiment

[0110] The second preferred embodiment represents an advanced configuration of the device, designed for specialised applications and users with specific needs. This variant, illustrated in Figure 1, incorporates additional technical elements that enhance the performance and versatility of use thereof.

[0111] The advanced configuration has an asymmetrical geometry of the distal portion, with the larger-sized relief positioned in the distal rather than in the central area. This configuration is optimised for users with a specific anatomy or for applications requiring a more intensive cleaning action in the distal area.

[0112] The main distal relief 20 has a base diameter of 14 mm and a height of 7.5 mm, becoming the dominant element of the system. The two secondary reliefs, 16 and 18 symmetrically positioned with respect to the geometric centre of the distal portion, have the same dimensions: a diameter of 8 mmand a height of 3.5 mm. This configuration creates an asymmetrical pressure profile that adapts to specific anatomical requirements.

[0113] This second configuration incorporates a controlled longitudinal curvature of the whole structure of the device. The longitudinal axis follows an arc with a radius of curvature of 180-220 mm, which naturally orients the distal portion at an optimal angle with respect to the perianal area in the standard use.

[0114] This curvature is achieved through a precise control of residual stresses during the moulding process, using a differentiated temperature profile along the mould: 210°C in the proximal area, gradually decreasing to 190°C in the distal area. The controlled cooling at a rate of 2-3°C / min stabilises the desired curvature.

[0115] The surface of the cleaning distal portion 14 in the second configuration has a biomimetic micro-texture that replicates more faithfully the structure of the papillae of the bovine tongue. This texture is characterised by microcavities with a diameter of 0.2-0.5 mm and a depth of 0.1-0.3 mm, distributed according to a hexagonal pattern with a density of 15-20 elements per cm2.

[0116] The micro-texture is obtained through a laser texturing process of the mould, which allows a precise control of the geometry and of the distribution of the micro-cavities. This treatment increases the effective surface area by 35-40% with respect to the standard configuration, significantly improving the residue removal effectiveness.

[0117] The second configuration also incorporates a more sophisticated tactile and visual identification system, not shown in the drawings. The proximal portion has differentiated grip areas with specific textures: a smooth area for the thumb to rest, a micro-ribbed area for the index finger, a dotted area for the middle finger. This system allows an instinctive positioning of fingers for an optimal control.

[0118] Third embodiment - Modular Configuration

[0119] The third preferred embodiment implements a modular approach that allows the device to be customized through the replacement of specific components, such as the cleaning distal portion 14, which is removable as in the examples in Figures 4 and 6. This configuration is particularly suitable for professional applications in the healthcare field or for users with varying needs.

[0120] The connection system between the proximal and distal portions is based on a standardised conical coupling with an angle of 7° and a coupling length of 12 mm. The distal portion incorporates an AISI 316L stainless steel metalinsert which ensures high mechanical strength and compatibility with advanced sterilisation processes.

[0121] The locking system uses a bayonet mechanism with three coupling sectors distributed at 120°. Each sector has an engagement length of 8 mm with a locking rotation angle of 30°. A system of visual and tactile indicators confirms the correct coupling and locking of the components.

[0122] This modular configuration provides four interchangeable variants of the distal portion, each optimised for specific applications:

[0123] A configuration with three reliefs for normal daily use.

[0124] A gentle configuration with reduced reliefs (height 50% lower) for users with high sensitivity.

[0125] An intensive configuration with increased reliefs (height 30% higher) for maximum cleaning effectiveness.

[0126] A specialised and asymmetrical configuration for specific anatomies.

[0127] Moreover, the modular configuration uses superior grade materials to ensure an extended durability and compatibility with repeated sterilisation cycles. The proximal portion is made of PEEK (polyether ether ketone) with a tensile strength at break of 100 Mpa and a continuous operating temperature up to 250°C.

[0128] The cleaning distal portion 14 uses USP Class VI and ISO 10993 certified pharmaceutical grade platinum-cured silicone, which ensures total biocompatibility and resistance to ethylene oxide, gamma radiation and autoclave sterilisation processes.

[0129] Fourth embodiment - Single-use Configuration

[0130] The fourth preferred embodiment is specifically designed for single-use applications in the hospital and hotel sector or for travels. This configuration optimises the cost-performance ratio for single uses, while maintaining the functional effectiveness of the standard configuration. This single-use configuration has a simplified structure with reduced thicknesses to minimise the material consumption. The proximal portion has a thickness of 2.5-3.0 mm (with respect to 4-5 mm of the above first configuration) while maintaining the mechanical strength necessary for the single use.

[0131] The cleaning distal portion 14 has a simplified relief system with only two elements, as shown in Figure 2: an elongated distal relief with a diameter of 10 mm and a height of 5 mm, and a rounded proximal relief with a diameter of at least 18 mm and a height of 3.5 mm. This configurationreduces the mould complexity and production cycle times while maintaining a cleaning effectiveness of over 85% with respect to the standard configuration.

[0132] The single-use configuration uses cost-optimised materials: recycled polypropylene for the proximal portion and TPE (Thermoplastic Elastomer) for the distal portion. TPE has a Shore A hardness of 35, an elongation at break of 300%, and a cost which is 40% less than LSR silicone.

[0133] Each single-use device is individually packaged in a sealed pouch of a multilayer barrier film (PET / Al / PE) that ensures sterility for 24 months. The packaging incorporates an easy-open system and a separate compartment for a single-use disinfectant wipe.

[0134] Fifth embodiment

[0135] Finally, as clearly shown in Figure 8, the device according to the present disclosure, in this case indicated with the numeral 1”’, can be shaped like a “soap bar”, that is with a support portion 10”’ that substantially corresponds in shape and size to the cleaning portion 14.

[0136] In fact, in this alternative embodiment, the device 1’” is held with a firm manual grip that retains the side walls of the support portion 10””. The presence of a lower transverse band (not shown in the figure) may also be provided, which allows to insert the hand and better to retain the support portion 10”’.

[0137] A person skilled in the art understands that the embodiments described and illustrated above can be easily modified and combined with each other by selecting a different shape of the cleaning portion 14 with respect to the support portion 10.

[0138] The operation of the device according to the present disclosure is completely intuitive, as schematically illustrated in Figure 4, and it does not require further explanations, except to point out that the most frequent and effective application may be the domestic use.

[0139] In fact, domestic use represents the primary use case for the device, characterised by repeated uses in a controlled environment with the possibility of complete sanitisation between uses. In this context, the device completely replaces the use of traditional toilet paper, offering significant advantages in terms of effectiveness, comfort and environmental sustainability.

[0140] The domestic use follows a standardised protocol that maximises the cleaning effectiveness while minimising hygiene risks. After defecation, the user holds the device by the proximal portion, maintaining a firm butrelaxed grip. The device is positioned so that the convex reliefs gently meet the perianal area.

[0141] The cleaning movement consists of 3-5 longitudinal passes with controlled pressure, followed by 2-3 transverse passes for perimeter finishing. The pressure applied must be sufficient to ensure the contact between the reliefs and the skin surface without causing any discomfort: typically 2-4 N of total force, corresponding to 0.2-0.4 N / cm2of specific pressure.

[0142] After each use, the device undergoes a sanitisation cycle comprising three steps:

[0143] 1. **Preliminary rinsing**: Removal of macroscopic residues with running water at room temperature (15-25°C) for 30-60 seconds

[0144] 2. **Detergent washing**: Application of a neutral detergent (pH 6-8) with gentle mechanical action for 60-90 seconds

[0145] 3. **Disinfection**: Application of an alcohol-based disinfectant spray (70-80% ethanol concentration) with a contact time of 2-3 minutes Thanks to its structure and configuration the device according to the present disclosure achieves several measurable technical effects which follow.

[0146] For example, comparative tests demonstrate a residue removal effectiveness of over 95%, which is significantly higher than traditional toilet paper (typical efficiency 60-70%).

[0147] Moreover, the distribution of the force applied on a larger surface reduces the specific pressure on the perianal area by 40-60% with respect to traditional methods.

[0148] The anti-adhesive structure reduces the residual bacterial load on the device 1 after cleaning by 99,9% with respect to traditional surfaces.

[0149] The device 1 is reusable after washing and eliminates toilet paper consumption, reducing the environmental impact by 90% per user on the annual basis.

[0150] Moreover, the device 1 has a universal applicability, adapting to different conditions of use through specific structural variants. The reusable version is intended for domestic use with controlled sanitisation cycles, while the single-use version is designed for applications in the hospital and hotel sector or for travels.

[0151] The technical innovation represented by device 1 opens new commercial possibilities in the personal hygiene sector, with a potential market estimated at millions of users in industrialised countries.In short, the above advantages can be summarised in the following points: 1. Ability to exert a controlled and uniform pressure on the surface to be cleaned;

[0152] 2. Surface structure optimised for the mechanical removal of residues without causing microtrauma;

[0153] 3. Biocompatible and easily sanitizable materials;

[0154] 4. Portability and ease of use in different environmental conditions;

[0155] 5. Environmental sustainability through the reusability of the device;

[0156] 6. Low cost to promote accessibility and widespread use.

Claims

CLAIMS1. A device ( 1 , 1 ’, 1”, 1 ” j for personal hygiene after defecation comprising:a scoop or paddle with a first proximal portion (10, 10’, 10”, 10’”) of support and handgrip (12) configured as an ergonomic handle and a second distal functionally independent portion (14, 14’, 14”, 14’”) configured for cleaning;at least one convex relief (15) similar to a cushion on said second cleaning distal portion (14);and wherein the material which said second cleaning distal portion (14, 14’, 14”, 14’”) is formed of is softer than the material of the first proximal portion (10, 10’, 10”, 10’”) of support and handgrip (12) of the scoop or paddle, thus implementing a soft mechanical cleaning action.

2. The device according to claim 1, wherein the second cleaning distal portion (14, 14’, 14”, 14’”) has the shape of a bi-elliptical simple leaf.

3. The device according to claim 1, wherein the second cleaning distal portion (14, 14’, 14”, 14’”) has a plurality of small peripheral reliefs (30) surrounding the convex relief (15).

4. The device according to claim 1, wherein the second cleaning distal portion comprises at least two convex adjacent reliefs.

5. The device according to claim 1, wherein in the cleaning distal portion (14”, 14”j the convex reliefs are at least three (16, 18, 20).

6. The device according to claim 5, wherein said convex reliefs (16, 18, 20) are aligned along the major axis of symmetry of the device.

7. The device according to claim 5, wherein the distal convex relief (20) or the centrale one (18) are more protruding than the other adjacent reliefs.

8. The device according to claim 5, wherein, in order of size, the distal relief is the largest, the central relief is the second in size and the proximal relief is the smallest.

9. The device according to claim 5, wherein small peripheral reliefs (30) surround the convex reliefs (16, 18, 20) aligned along the axis of symmetry.

10. The device according to claim 9, wherein said small peripheral reliefs (30) are shaped as narrow and elongated small leaves or drop-shaped.

11. The device according to claim 1 wherein the cleaning distal portion (14, 14’, 14”, 14’”) is made of a silicone material which an antioxidant vitamin E filler is added to.

12. The device according to claim 1, wherein the cleaning distal portion (14, 14’, 14”, 14’”) is made of a soft silicone material with a hardness (Shore A) comprised in a range between 20 and 40.

13. The device according to claim 12, wherein said silicone material is a USP Class VI and ISO 10993 certified pharmaceutical grade platinum-cured silicone, which ensures total biocompatibility and resistance to ethylene oxide, gamma radiation and autoclave sterilisation processes.

14. The device according to claim 1, characterized in that it is manufactured through a bi-material moulding process with the complete structural integration of the two components that form the first proximal portion (10, 10’, 10”, 10’”) of support and handgrip (12) and the second cleaning distal portion (14, 14’, 14”, 14’”) in a single production cycle.

15. The device according to claim 1, wherein the first proximal portion (10, 10’, 10”, 10’”) of support and handgrip (12) and the second cleaning distal portion (14, 14’, 14”, 14’”) are structurally independent, removable from each other and coupled to each other by means of a mechanical interlocking coupling or chemical / physical bond.

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