Device for female urination in supine position

Abstract

It comprises a tubular body (10) whose cross-section decreased towards a distal end (12) away from the patient's body. The center of each cross-section defines a curved path (C) passing through a proximal point (P0) whose radius is R0 = [(3 / 5) x h], with (h) being a projection on a horizontal plane of the path (C), and a horizontal slope (β0), in the position of use; a point (P1) at a distance d1 = [(4 / 5) x h] from the distal end (12) whose radius is (R1) = [(1 / 5) x h], and slope (β1)= 25-35°; a point (P2) at a distance (d2) = [(13 / 20) x h] from the distal end (12) whose radius is (R2) = [(9 / 25) x h], and slope (β2) = 45-55°; a point (P3) at a distance (d3) = [(1 / 3) x h] from the distal end (12) and slope (β3) = 20-30°; and a distal point (P4) of maximum radius.

Description

[0001]

[0002] DESCRIPTION

[0003] The present description relates to urination devices for female patients in the supine position.

[0004] This application claims the benefit of the Spanish Patent application P202330948 filed 16 November 2023.

[0005] BACKGROUND

[0006] The use of external urine collection devices such as bedpans is well known. Urine collection bedpans allow urine collection in the supine position and typically consist of a rigid plastic part that can be sanitized, and a single use recycled rough cardboard part that fits over the rigid plastic part. One of the main drawbacks of bedpans is that their design is not adequately adapted to female anatomy. Consequently, the use of bedpans for the collection of female urine may lead to sustained pressure injuries and wetting injuries related to leakage of body fluid. The use of bedpans may also increase urinary retention related to incomplete bladder emptying due to incorrect positioning.

[0007] Although devices have been proposed for female urine collection with a design adapted to the pelvic area or to the labia minora of the patient's vagina, these devices continue to suffer from sealing problems, with leaks occurring due to poor sealing and fixation.

[0008] In US2016067132A1 a urination device for female use is provided that can be used in supine position. Such urination device, intended for urine storage, comprises a tapering body, at the proximal end of which a curved portion is provided. The body of the urination device further includes an intermediate portion for the flow of fluid. Such intermediate portion us externally provided with a roughened area and an annular grip handle. Said urination device for female use does not solve all the problems existing in urine collection in women in the supine position, since its geometry is not particularly optimized.

[0009] Urination devices for female use known so far still do not solve the problem of injuries that are often caused by sustained pressure and also by moisture due to leakage of body fluid. This may also increase the number of urinary retention related to incomplete bladder emptying due to awkward positions.

[0010] There thus remains a need for a urination device that is safe, effective, and comfortable for use by a woman who is restricted to a supine position due to various medical circumstances and to any disabling situation that may require it.

[0011] SUMMARY

[0012] The inventors have found an optimal configuration for a device for female urination in supine position with which at least the disadvantages existing so far are mitigated and with which a number of additional advantages are obtained as will be seen further below.

[0013] The present device is intended for any type of woman in the supine position, it is applicable to various pathologies, and it is also configurable for various sizes. It is not necessary to leave the device in place, but it is used only at the time of urination.

[0014] The present device for female urination in supine position comprises a tubular body extending from a proximal end to a distal end. The proximal end of the tubular body is intended to be adjacent to the patient’s or user’s body. The distal end of the tubular body, opposite to the proximal end, is located away from the patient's or user's body.

[0015] Hereinafter the term "patient" in the present description refers to any person using the present urination device, whether or not requiring health care, and whether or not subject to professional care for maintenance or recovery of his or her health.

[0016] Also within the context of the present description, the term tubular refers to the fact that the body of the device has a tube-shaped configuration, that is, having an elongated, hollow, or rounded contour, such as elliptical or circular, and open at the ends thereof.

[0017] The tubular body of the device may be made of a single piece. In this way, the device does not require assembly operations before, during, and after use. However, it is also envisaged that the tubular body may be formed of multiple interchangeable parts to facilitate customization and adaptability. In the latter case, the device may be reconfigured into different variants as required, during manufacturing process and use thereof. This allows customization of the device while maintaining its ease of use as if it were a single piece device.

[0018] The tubular body of the present device is made of a urine-resistant material, in particular of polymers having a certain flexibility, compatible with contact with sensitive areas of the human body and with cleaning and disinfection products, such as chemical, thermal, UV, etc. treatments. The device described herein may be manufactured by molding, blow molding, and also by additive manufacturing. Other manufacturing methods are possible.

[0019] The tubular body of the device for female urination has a geometry defined by cross sections having an area that decreases towards said distal end of the tubular body, that is, cross sections that, starting from a given point of the tubular body, have an area that decreases as said sections are arranged further away from the patient's body.

[0020] The center in each of said cross sections of the tubular body of the device defines a particular curved path. Said curved path is such that it passes through at least five characteristic points, which are described herein below.

[0021] The first point of the curved path passing through the center of each cross section of the tubular body of the device is a proximal point at or near the proximal end of the tubular body. At said proximal point, the curved path has a curvature whose radius is 3 / 5 of a distance corresponding to a projection on a horizontal plane of a length of said curved path. At said proximal point, the curved path has a slope substantially parallel to a horizontal axis, in the position of use.

[0022] In an optimal configuration, in the position of use of the device, the tubular body is inclined at an angle of 15-35° with respect to the horizontal, preferably at an angle of 25° with respect to the horizontal. That is, once in position, the device is slightly inclined 15-35° below a horizontal plane, preferably 25°, as stated above.

[0023] The second point of the curved path passing through the center of each cross section of the tubular body of the device is a point which is located at a distance from the distal end of the tubular body equivalent to 4 / 5 of said distance corresponding to a projection on a horizontal plane of a length of said curved path. At said second point, the curved path has a curvature whose radius is equivalent to 1 / 5 of said distance corresponding to a projection on a horizontal plane of a length of said curved path. At said second point, the curved path has a slope of 25- 35°. Optimally, said slope is 30°.

[0024] The third point of the curved path passing through the center of each cross section of the tubular body of the device is a point which is located at a distance from the distal end of the tubular body equivalent to 13 / 20 of said distance corresponding to a projection on a horizontal plane of a length of said curved path. At said third point, the curved path has a curvature whose radius is equivalent to 9 / 25 of said distance corresponding to a projection on a horizontal plane of a length of said curved path. At said third point, the curved path has a slope of 45-55°. Optimally, said slope is 50°.

[0025] The fourth point of the curved path passing through the center of each cross section of the tubular body of the device is a point which is located at a distance from the distal end of the tubular body equivalent to 1 / 3 of said distance corresponding to a projection on a horizontal plane of a length of said curved path. At said fourth point, the curved path has a maximum curvature whose radius tends to infinity. At said fourth point, the curved path has a slope of 20-30°. Optimally, said slope is 25°.

[0026] The fifth point of the curved path passing through the center of each cross section of the tubular body of the device is a distal point at or near the distal end of the tubular body. At said fifth distal point, the curved path has a maximum curvature whose radius tends to infinity.

[0027] Of course, the curved path passes through the center of infinite cross sections of the tubular body of the device, although the five points described above are the basic essential points through which the curved path that defines the shape of the tubular body of the present device passes.

[0028] Surprisingly, it has been found that the specific curved path described above, which follows the axis defined by the geometry of the tubular body, greatly facilitates the flow of fluid to the outside of the device, and advantageously avoids fluid spills. Said curved path is preferably a non-uniform rational B-Spline (NURBS) type path that allows to accurately define the 3D geometry of the tubular body based on the above mentioned control points.

[0029] Optimally, the cross-section perpendicular to the curved path of the tubular body at the first proximal point is elliptical, although it may be of any other suitable shape. Also optimally, the cross section perpendicular to the curved path of the tubular body at the fifth distal point is circular. Other suitable shapes are also possible.

[0030] In one example of the present device for female urination in supine position, the tubular body has three main portions defined along its length. Specifically, the tubular body of the present device has a proximal portion, an intermediate portion, and a distal portion, which will be described in detail further below.

[0031] The proximal portion is located at or near the proximal end of the tubular body and corresponds to a portion through which the fluid enters and flows by decanting. The proximal portion of the tubular body is wider than the rest of the tubular body, that is, the tubular body widens at the beginning in order to collect more fluid in the case of a higher intensity of urination fluid velocity.

[0032] Said proximal portion of the tubular body includes a fluid inlet member. Said fluid inlet member may be solid or hollow and preferably it has an annular geometry configured to suitably adapt to the female anatomy, allowing a good contact and fit with the patient's body, as explained below. Said annular geometry may optimally have an elliptically shaped outer perimeter.

[0033] Specifically, the fluid inlet member has, as viewed from a side view, a toroidal geometry defining a slightly curved C-shaped configuration with variable radius. Specifically, said C- shape has respective radii at the ends thereof whose value is smaller than the value of the radius in a central portion of the C-shape of the fluid inlet member.

[0034] It has been shown that the configuration described herein provides an optimal fitting and coupling of the device to different physiognomies of the female urethra in the supine position, ensuring a proper sealing of the device inside the patient's vagina. During the use of the device, the lower portion of the annular fluid inlet member is in a position such that, in case of a vertical flow drop or if flow exits with low pressure, the fluid always passes inside the tubular body of the device and, if the fluid flows in the opposite direction by Coanda effect, that is, if it becomes attached to the nearby surface of the human tissue instead of following its natural path, the fluid is also collected inside the tubular body of the device, due to the particular curved shape of the fluid inlet member described above.

[0035] Therefore, with the aforementioned fluid inlet member configured as described above, having a slightly curved C-shape whose central radius is larger than the end radii, the proximal portion of the tubular body is a specific fitting portion capable of suitably adapting to the female labia minora to remain in tight contact therewith, adjusting as much as possible to the urethral meatus. As a result, an optimal and effective sealing of the contact portion of the device with the patient in the supine position during use is obtained.

[0036] Preferably, the dimensions of the annular fluid inlet member are larger than the dimensions of the other parts of the tubular body. Therefore, the annular fluid inlet member protrudes outwardly from the tubular body, in particular from the proximal portion thereof. As a result, the use of the present device in the external portion of the patient's vagina is prevented.

[0037] The annular fluid inlet member is preferably more flexible than the rest of the tubular body. In one example, the annular fluid inlet member is flexible and soft, so that it can be elastically deformed such that the device can be adapted to the female meander. The rest of the tubular body has different elasticity, in particular being stiffer and harder than the annular fluid inlet member. In this way, device handling is advantageously facilitated, avoiding deformation of the device in portions other than the proximal portion, while maintaining comfort in said proximal portion.

[0038] Due to the configuration disclosed herein, once the device is placed inside the patient's labia minora, the annular fluid inlet member recovers its initial shape due to its flexibility and applies sufficient pressure on the walls of the labia minora, mainly on a central portion thereof, so that it is suitably attached, without the need to use additional external rings, adhesives or other attaching means, such as suction effect elements, so as to obtain a good seal and prevent backward movements of the device as the patient's labia minora close when the device is in place. Thus, a simple, cost-effective, and very efficient device is obtained, with no leakage.

[0039] The annular fluid inlet member of the device has a continuous contour, with no geometric interruptions. This improves comfort once it is in place, since there are no peaks, angles, or other geometries causing discomfort or pain to the patient.

[0040] For its part, the intermediate portion of the tubular body, adjacent to the proximal portion, is intended for the flow of fluid internally by decantation. Said intermediate portion preferably has an elliptically shaped cross-section. However, other shapes are possible. The distal portion of the tubular body, adjacent to the intermediate portion, is located at or near the distal end of the tubular body. Said distal portion, opposite to the proximal portion, is adapted for the flow of fluid to the outside of the device, for evacuation thereof. For this purpose, the distal portion may be suitably attached or coupled to any tubing and any urine collection element, diuresis bag, etc. without the need for adapters or other coupling fittings or other types of fittings. In this way, the urine collected from the patient can flow into any type of suitable collection device, without requiring a specific urine collection element.

[0041] According to an optimal design of the tubular body of the present device for female urination in supine position, it is satisfied that: 4 x h = 21 x a, with h being a distance of a horizontal projection of the length of the curved path of the tubular body, and with a being a maximum dimension of the fluid inlet member.

[0042] If required, the present device may further include a separation flange. The separation flange may have a flat configuration, although many other different configurations are possible, including an annular configuration. If provided, said separation flange may be a separate member of the tubular body or it may be formed integral with the tubular body. The separation flange is intended to separate the contact portion from the flow portion, close to the patient's body, thus improving the hygienic use of the device. Also, the separation flange is sized to act as a member for abutting against the patient's body. The separation flange can also serve as an abutting member or limit for placing the device in the patient's body.

[0043] The present device may also be provided with a holding handle, preferably arranged in a distal portion of the tubular body. The holding handle may be in the form of a ring, although many other configurations are possible, including a flat configuration. The holding handle facilitates handling, fitting, and removal of the device. The holding handle is also configured to hang the device in order to wash, dry, and disinfect it, thus avoiding the generation of waste, as well as to facilitate subsequent storage for reuse. With the holding handle, the device can be comfortably handled, reducing pain during both insertion and removal of the labia minora of the patient's vagina, thus minimizing direct contact of the caregiver's hand with the patient's body. As with the separation flange, if provided, said holding handle may be a separate part of the tubular body or it may be formed integral with the tubular body.

[0044] The present device may further include a gripping portion. The gripping portion is preferably a textured or roughened part. Said gripping portion may have any suitable configuration for an improved gripping and holding of the device allowing easy handling of the device. The gripping portion, if provided, is formed on at least an outer portion of the tubular body, in particular, formed on a top portion, and / or on a side portion, and / or all around the outside of the tubular body.

[0045] The mode of use of the present device is as follows. First, a slight pressure is applied by the patient or caregiver on the cross-section of the proximal portion, in particular on the annular fluid inlet member. Since said fluid inlet member is elastic, when slightly pressed, it suitably adapts to the female anatomy, centering it at the outlet of the urethra.

[0046] Since the device is not a permanent-use device as stated above, it is removed once the patient has urinated. To remove the device, slight pressure is again applied to the proximal portion cross-section of the tubular body, at the annular fluid inlet member, in order to deform it slightly and remove it. After use, the device is washed and disinfected using appropriate equipment for subsequent reuse.

[0047] In a further aspect of the present description, there is provided a device for female urination in supine position comprising a tubular body extending from a proximal end intended to lie adjacent to the patient's body to a distal end arranged away from the patient's body. Regardless of the shape or geometry of the tubular body of the device, in this further aspect of the present description, a fluid inlet member is provided at or near the proximal end of the device, configured such that, during use of the device with the patient in the supine position, it is in watertight contact with the female labia minora. Said fluid inlet member has the configuration, shape, and geometry as described above.

[0048] The urination device for female patients in the supine position, according to the aspects described above, has many advantages, as explained below, and it is an alternative, simpler and more cost-effective solution as compared to the devices that have been used for the same purpose up to now.

[0049] Firstly, it is a non-invasive device, the use of which requires less intervention by the health care team, caregiver, or the patient herself to remain static in its position of use as compared to the devices that have been used for the same purpose up to now. Secondly, the present device is simple and cost-effective, and is capable of giving an effective, simple, and cost-effective response that is suitably adapted to the physiological variabilities that occur when urinating in the supine position.

[0050] By having a continuous and rounded geometry, the present device provides great comfort and convenience of fitting, use, and removal, without causing unwanted pain.

[0051] On the other hand, the described geometry of the tubular body allows scaling the device in its production in different sizes taking into account both the anatomy of the genital area of different patients and the intensity of urination, especially a proximal portion of the device.

[0052] In addition, the particular configuration of the tubular body of the device disclosed herein, with the toroidal shape of the annular fluid inlet member in its proximal portion, avoids spillages in the use of the device when employed in the supine position, which occur in other known urination devices due to lack of fit and tightness, and due to the Coanda effect that occurs due to the tendency of the fluid flow to become attached to a nearby surface, generating unwanted spillages, as well as skin irritation and difficulty in directing the flow in an accurate manner. This advantage is important since these problems may affect comfort, hygiene, and efficiency of the urinating process in this position.

[0053] The present device also allows, as stated above, a very stable attachment, without backward movements, once in place. As a result, injuries to the patient are avoided.

[0054] Since the configuration of the device herein described, intended specifically for the supine position, is such that, in use, the tubular body comes into contact with the female labia minora, the device can be considered a hygienic product, and does not necessarily have to be of a sanitary type, resulting in less regulations being required for its marketing and use.

[0055] From the point of view of sustainability and environmental impact, it is a reusable device that can be cleaned and sanitized after use.

[0056] Furthermore, the present device does not require the use of external electrical power for its operation, or external suction systems, vacuum sources, adhesives, or suction cups. Additional advantages and features of the present device will become apparent to those skilled in the art upon examination of the description, or they may be learned by practice thereof.

[0057] BRIEF DESCRIPTION OF THE DRAWINGS

[0058] One non-limiting example of a device for female urination in supine position will be described in the following, with reference to the appended drawings.

[0059] In the drawings:

[0060] Figure 1 is a general perspective view of one example of the present device for female urination in supine position;

[0061] Figure 2 is a fragmentary elevational view of the device for female urination in figure 1 ;

[0062] Figure 3 is a graph illustrating a curved path passing through the center of cross sections defining the geometry of the tubular body of the device for female urination of figures 1 and 2;

[0063] Figure 4 is a top plan view of the device shown in figure 2; and

[0064] Figure 5 is a front view of the device shown in figure 2.

[0065] DESCRIPTION OF EXAMPLES

[0066] The non-limiting example illustrated in figures 1-5 of the drawings corresponds to a device for female urination in supine position.

[0067] In the figures, the device has generally been designated with reference sign 100. The device 100 comprises a tubular body 10. The tubular body 10 is made of a urine resistant material, preferably of a polymer of a flexible nature and compatible with contact with sensitive areas of the human body. The tubular body 10 may be manufactured by molding, blow molding, or by additive manufacturing, for example.

[0068] Referring to figure 1 of the drawings, the tubular body 10 extends from a proximal end 11 located next to or near the patient's or user's body (not shown), in the position of use, to a distal end 12, opposite said proximal end 11 , away from the patient's or user's body. In the non-limiting example illustrated in the figures of the drawings, the tubular body 10 is made of a single piece, so that before, during, and after use of the device 100 no assembly operations are required. In other variants, the tubular body 10 of the device 100 could be formed of various interchangeable parts to facilitate customization and adaptability according to the needs.

[0069] The tubular body 10 of the device 100 has a particular geometry with which the inventors have found an optimal solution for female urination in supine position. With the configuration described below, the flow of fluid to the outside of the device 100, that is, from the proximal end 11 to the distal end 12, is advantageously facilitated without the need to use other additional elements to ensure tightness.

[0070] Said particular geometry of the tubular body 10 is defined by infinite cross-sections thereof, of different sizes. Starting from a given point of the tubular body 10, said cross-sections of the tubular body 10 has an area that decreases towards the distal end 12, that is, as they are arranged further away from the patient's body.

[0071] Since the body 10 is tubular in nature, it has a tube-like configuration, that is, elongated, hollow, with a rounded contour, such as elliptical or circular, and open at its ends 11 , 12. Therefore, a center is defined in each of said cross-sections thereof. By connecting the centers of said cross sections of the tubular body 10 of the device 100 a curved path C is defined as depicted in figure 3. Said figure 3 shows the path C of the tubular body 10 of the device 100 when the latter is in the position of use. In said position, the tubular body 10 is inclined at an angle a = 25° below a horizontal plane.

[0072] Said curved path C is a non-uniform rational B-Spline (NURBS) type curved path, which is described in detail herein below with particular reference to the graph in figure 3 of the drawings. Said curved path C passes through at least five characteristic points of the NURBS curve. These points are described below, where a parameter h has been considered as a distance corresponding to a projection on a horizontal plane of a length of the path C.

[0073] Following the path C of the tubular body 10 of the device 100 from left to right, that is, from the proximal end 11 towards the distal end 12, the characteristic points of the NURBS curve are as follows, as described below: Po: proximal point that is located at or near the proximal end 11 of the tubular body 10. In the example of figure 3, the proximal point Po is located at a distance do from the distal end corresponding to said magnitude h of a length of the path C projected on a horizontal plane, that is, do = h. On the other hand, the path C at the proximal point Po has a curvature whose radius is Ro = [(3 / 5) x h]. At said proximal point Po, the path C has a slope Po = 0°, substantially parallel to a horizontal axis, in the position of use. The cross section of the tubular body 10 of the device 100 at said proximal point Po is elliptical in the example described and as shown in figure 5 of the drawings.

[0074] P point located at a distance di = [(4 / 5) x h] from the distal end 12 of the tubular body 10 and has a curvature whose radius is Ri = [(1 / 5) x h]. At this point Pi, the path C has a slope Pi = 30°

[0075] P2: point located at a distance d2 = [(13 / 20) x h] from the distal end 12 of the tubular body 10 and has a curvature whose radius is R2 = [(9 / 25) x h]. At this point P2, the path C has a slope 2 = 50°

[0076] P3: point of the tubular body 10 of the device 100 located at a distance ds = [(1 / 3) x h] from the distal end 12 of the tubular body 10 and has a maximum curvature whose radius R3 tends to infinity. At this point P3, the path C has a slope 3 = 25°.

[0077] P4: distal point of the curved path C which is located at or near the distal end 12 of the tubular body 10 and has a maximum curvature whose radius is R4, which also tends to infinity. The cross section of the tubular body 10 at said distal point P4 is circular in the example herein described. As at the proximal point Po, at the distal point P4, the path C has a slope P4 = 0°, substantially parallel to a horizontal axis, in the position of use.

[0078] Referring back to figure 1 of the drawings, a proximal portion 20, an intermediate portion 30, and a distal portion 40 are defined along the tubular body 10 of the device 100, as illustrated.

[0079] The proximal portion 20 of the tubular body 10 contains said proximal point Po of the curved path C described above. Therefore, the proximal portion 20 of the tubular body 10 is located at or near the proximal end 11 . Said proximal portion 20 of the tubular body 10 corresponds to the portion through which the fluid enters the device 100 and flows by decanting therewithin. In the proximal portion 20, the width of the tubular body 10 is wider than the rest of the tubular body 10. Such configuration allows a greater quantity of fluid to be collected in case of a higher velocity of the urination fluid.

[0080] A fluid inlet member 25 is provided in the proximal portion 20, which is shown in detail in figure 2 of the drawings. Said fluid inlet member 25 has an annular or toroidal geometry, which may be solid or hollow.

[0081] The fluid inlet member 25 is of a flexible and soft nature, in particular, it is made of a material that is more flexible than the rest of the tubular body 10. In the example herein described the fluid inlet member 25 can be elastically deformed to suitably fit the device 100 to the female meander. The rest of the tubular body 10 has different elasticity. In particular, the rest of the tubular body 10 is made of a stiffer and harder material than the fluid inlet member 25. Thus, handling of the device 100 by healthcare personnel or caregiver is facilitated, preventing the device 100 from being deformed in portions other than the proximal portion 20, while maintaining comfort in the proximal portion 20.

[0082] Due to the flexible nature of the fluid inlet member 25, once the device 100 is placed inside the patient's labia minora, said fluid inlet member 25 recovers its initial shape by applying sufficient pressure on the walls of the patient's labia minora, mainly in its central portion, such that it is suitably attached preventing the device 100 from being withdrawn, when the patient's labia minora are closed.

[0083] As it can be seen in the figures, the fluid inlet member 25 has a continuous contour, without geometric interruptions, resulting in comfort being improved once in place, due to the absence of peaks, angles, or other geometries that may cause discomfort or pain to the patient. By having a continuous and rounded geometry, the device 100 provides great comfort and convenience of fitting, use and removal, without causing unwanted pain.

[0084] In the illustrated example, the annular geometry of the fluid inlet member 25 has an elliptically shaped outer perimeter, as shown in figure 5 of the drawings, adapted to the female anatomy, as described herein below.

[0085] Referring in particular to the fragmentary side elevation view of figure 2, the fluid inlet member 25 has a slightly curved C-shape with variable radius on the sides, in particular, a C-shape formed by multiple radii RA, RB, RC adjacent to each other. In the particular non-limiting example shown, the C-shape of the fluid inlet member 25 as shown in a side elevation view has respective radii RA, C at the ends and a central radius RB defining the curve of the fluid inlet member 25 as viewed from a side view. Said radii are different from each other, in particular, the radius at the ends of said C shape, that is, the radii RA, RC have a value smaller than the value of the radius RB in a central portion of said C shape.

[0086] More in detail, and continuing with the side elevation view of figure 2, the fluid inlet member 25 has a circular upper portion whose radius is RA = (1 / 10) x a, and an elliptically shaped lower portion arranged in oblique position, whose radius is Rc = (1 / 3) x a. As mentioned above, the value of said radii RA, RC is lower than the radius RB of the central portion of the fluid inlet member 25 in the aforementioned side elevation view, which has a radius RB = 2 x a, that is, larger than the own maximum vertical dimension a of the fluid inlet member 25.

[0087] The top end radius RA = (1 / 10) x a, corresponds to the radius of the circular shaped section of the upper portion of the fluid inlet member 25.

[0088] The central radius RB, in said side view, decreases in a non-linear manner into a radius of whose value is (1 / 3) x a, corresponding to the radius Rc of the lower end of said C shape.

[0089] Finally, the lower end radius, whose value is Rc = (1 / 3) x a, corresponds to the radius of the elliptically shaped section of the lower portion of the fluid inlet member 25. The change in section, from circle into ellipse in the lower portion, enlarges the latter area in the horizontal dimension thereof generating a greater contact surface with the patient’s urethral area, just in the area where there are more possibilities of spillage of the inner fluid.

[0090] The particular configuration of the proximal portion 20 described above provides a good contact and an optimal fitting of the device 100 to different physiognomies of female urethra in supine position. The configuration described above allows the device 100 to suitably adapt to the female labia minora to remain in tight contact therewith, adjusting as much as possible to the urethral meatus, ensuring a good sealing of the device 100 in the female anatomy with the patient in supine position during its use.

[0091] Moreover, thanks to the particular curved C-shape of the fluid inlet member 25 as viewed from a side view as described above, with different radii at its ends and in its central portion, the lower portion of said fluid inlet member 25, during the use of the device, remains in such a position that, in case of vertical drop of fluid or if fluid flows out at low pressure, fluid always flows inside the tubular body 10. If fluid flows in the opposite direction by Coanda effect due to the tendency of the fluid flow to become attached to a nearby surface, that is, the fluid may become attached to the nearby surface of the human tissue instead of following its natural path of vertical drop, which would be a disadvantage. With the geometry described above it has been found that the flow is directed in a very accurate way so that the fluid is always collected inside the tubular body 10 and it does not become attached to the nearby surface of the human tissue. Unwanted spillage and skin irritation are thus avoided. This advantage is important since, if they were to occur, these problems may affect comfort, hygiene, and efficiency of the urination process in this position.

[0092] As it can be seen in figures 1 and 4, the proximal portion 20 of the tubular body 10 protrudes outwardly from the rest of the tubular body 10. The dimensions of the fluid inlet member 25 are larger than the dimensions of the other parts of the tubular body 10. In this way, the area of use for the device is well defined.

[0093] In particular, as shown in the top view of figure 4, the sides of the fluid inlet member 25 also protrude from the outer wall of the tubular body 10. In this way, once the device 100 is positioned around the female meander, it is optimally attached, with no backward movement. In said top view, the fluid inlet member 25 is rounded arrow-shaped, as shown in figure 4. The configuration described facilitates gradually fitting the device 100 avoiding simultaneous positioning of the entire perimeter thereof, but rather the upper and lower points of the fluid inlet member 25 are first placed, thus facilitating visual alignment of the device 100. The concavity of the C shape further promotes fluid collection in case it slides downwards due to lack of pressure during urination.

[0094] The toroidal shape of the fluid inlet member 25 has a width wi = (9 / 1 O x a) wider than the width W2 = (3 / 4 x a) of the proximal portion 20, as shown in figure 4. In this way, once the device 100 is in place, it is correctly attached inside the patient's labia minora when they are closed, avoiding undesired movements in the frontal and vertical planes or in the direction of the curved path C.

[0095] This advantageously facilitates the process for fitting the device 100, since the upper portion of the fluid inlet member 25 is first easily fitted between the patient's labia minora and subsequently the side portion of the fluid inlet member 25. In this way, the device is fitted at two different times, which facilitates application thereof, and discomfort, and alignment difficulties are avoided.

[0096] Reference is now made to figure 5 of the drawings. As stated above, the fluid inlet member 25 has an elliptically shaped outer perimeter, as shown in said figure 5. Considering the parameter a as a maximum dimension of the fluid inlet member 25, corresponding to a major axis of said ellipse, in the example shown it is satisfied that 4 x h = 21 x a, with h being a distance of a horizontal projection of a length of the curved path C of the tubular body 10 as stated above.

[0097] According to the front view of the proximal portion 20 shown said figure 5 of the drawings, the minor axis of the ellipse defining the outer perimeter of the fluid inlet member 25 has a value b = 9 / 10 x a, with the parameter a corresponding to a length of the major axis of said ellipse, as stated above.

[0098] The inventors have found that the aforementioned values for a length of the major axis a and the minor axis b of the ellipse defining the outer perimeter of the fluid inlet member 25 and their proportions allow an optimal fitting of the proximal portion 20 of the tubular body 10 to a length and width of the patient's labia minora, adapting to the area around the urethral orifice and between said patient’s labia minora.

[0099] With continued reference to figure 5, the hole 21 through which the urination fluid enters the device 100 has a vertical dimension Ci and a horizontal dimension C2. The values of said vertical and horizontal dimensions c-i, C2 of the fluid inlet holes 21 are both proportional to the length a of the ellipse major axis of the fluid inlet member 25. In particular, the vertical dimension has a value Ci = (3 / 5) x a, and the horizontal dimension has a value C2 = (1 / 2) x a.

[0100] The aforementioned dimensions c-i, C2 of the hole 21 through which the urination fluid enters make it possible to adapt the proximal portion 20 well to the urination outlet of the urethra. The hole 21 through which the urination fluid enters the device 100 has a centroid 21a that is slightly offset above the corresponding centroid 25a of the fluid inlet member 25. The relative offset of said centroids 21a, 25a is set at an optimum magnitude of 1 / 25 x a.

[0101] Thanks to the configuration described above, urine outflow is facilitated which, by gravity, will tend to flow downwards. The thickness of the fluid inlet member 25 is thicker in the lower portion thereof which allows an optimal sealing of said portion where fluid is most likely to spill and exit the device 100.

[0102] The particular configuration described for the fluid inlet member 25 may be independent of the configuration of the tubular body 10, that is, it may be independent of the aforementioned geometry of infinite cross-sections of different sizes, the connection of whose centers defines a curved path C described and depicted in figure 3, passing through at least the five characteristic points described above.

[0103] With continued reference to figure 1 , the intermediate portion 30 of the tubular body 10 is adjacent to the proximal portion 20. The intermediate portion 30 is intended for the flow of fluid internally by decanting. In the example described, the intermediate portion 30 has an elliptical ly shaped cross-section.

[0104] The distal portion 40 of the tubular body 10, adjacent to the intermediate portion 30, is opposite the proximal portion 20, being located at or near the distal end 12 of the tubular body 10. The distal portion 40 is adapted for the flow of fluid to the outside of the device 100, for evacuation. Said distal portion 40 of the tubular body 10 can be attached or coupled to any tubing and urine collection element, diuresis bag, etc., not shown.

[0105] The device 100 further includes a separation flange 50, as shown in the aforementioned figure 1 . The separation flange 50 is a flat disc-like body arranged externally surrounding the tubular body 10, adjacent to the fluid inlet member 25, in the proximal portion 20. In the example described herein, the separation flange 50 is formed integral with the tubular body 10 although it may be a separate member.

[0106] The separation flange 50 serves the purpose of improving the hygienic use of the device. To this end, the separation flange 50 is configured and sized to suitably separate the contact area of the tubular body 10 with the patient from the flow area, close to the patient's body.

[0107] The device 100 further includes a holding handle 60, as shown in figure 1 of the drawings. In the example described herein, the holding handle 60 is ring-shaped, with a semicircular perimeter, whose ends are joined to the outer surface of the tubular body 10. Other suitable shapes for the holding handle 60 of the device 100 are possible. The holding handle 60 facilitates operations for handling, placing, and removing the device

[0108] 100. In particular, the holding handle 60 allows for convenient fitting and removal of the device.

[0109] In addition, the holding handle 60 allows the device to be hung, as well as to be washed, dried, disinfected to avoid the generation of waste, as well as to facilitate its subsequent storage for reuse. In the example described herein, the holding handle 60 is formed integral with the tubular body 10 although it may be a separate member.

[0110] With continued reference to figure 1 of the drawings, in the intermediate portion 30 of the tubular body 10 a gripping portion 70 is arranged configured as a textured or roughened area, in particular, with a plurality of elongate protrusions formed on upper and lateral portions of the outer surface of the tubular body 10 extending transversely to a length thereof. The gripping portion 70 facilitates handling of the device 100 with increased effectiveness.

[0111] To use the present device 100, the fluid inlet member 25 is first pressed at the proximal portion 20 until it is suitably adapted to the female meander, centered on the urethral outlet. Once it has been used after the patient has urinated, the device 100 can be easily removed by again applying slight pressure on the fluid inlet member 25 to deform it slightly and remove it. The device 100 is therefore not for permanent use, but is removed after use, after which it is washed and disinfected, leaving it ready for subsequent reuse.

[0112] The device for female urination in supine position 100 described herein is a simple, cost- effective, and non-invasive solution that requires very little intervention by the caregiver or the patient herself to remain static in its position of use. The device 100 described herein can adapt well to the physiological variabilities that occur when urinating in the supine position.

[0113] A particular example of the present urination device intended for female patients in supine position has been disclosed herein. However, it will be understood by those skilled in the art that other alternative examples and / or uses and obvious modifications and equivalents thereof are possible. For example, regardless of the geometry of the tubular body of the device, the device may have the rest of one or more of the features disclosed herein, for example, it may have a proximal portion and an intermediate portion both having an elliptically shaped crosssection, a distal portion having a circular cross-section, a fluid inlet member with the dimension relationships described above configured to be in tight contact with the female labia minora, with the C-shaped curved geometry described above, as viewed from a side view, with respective radii at the ends of said C-shape smaller than the radius in a central portion of said C-shape, the tubular body configured to be inclined, in the position of use, at a certain angle with respect to the horizontal, with a separation flange, a holding handle, a gripping portion, etc.

[0114] Reference signs related to drawings placed in parentheses in a claim are solely for attempting to increase its intelligibility and shall not be construed as limiting the scope of the claim.

[0115] The scope of the present description should not be limited by the example described herein but should be determined only by a fair reading of the claims that follow.

Claims

CLAIMS1. Device (100) for female urination in supine position, the device (100) being formed with a tubular body (10) extending from a proximal end (11) intended to be arranged next to the patient's body, to a distal end (12) arranged away from the patient's body, characterized in that the tubular body (10) has a geometry defined by cross sections which, starting from a given point of the tubular body, have an area which decreases as said sections are arranged further away from the patient's body, the center of each of said cross sections defining a curved path (C) such that, being (h) a projection on a horizontal plane of a length of the curved path (C), said curved path (C) passes at least through:- a first proximal point (Po) located at or near the proximal end (11) of the tubular body (10), wherein the curved path (C) has a curvature whose radius is Ro = [(3 / 5) x h], with a slope Po substantially parallel to a horizontal axis, in the position of use;- a second point (Pi) located at a distance di = [(4 / 5) x h] from the distal end (12) of the tubular body (10), wherein the curved path (C) has a curvature whose radius is Ri = [(1 / 5) x h], with a slope Pi = 25-35°;- a third point (P2) located at a distance d2 = [(13 / 20) x h] from the distal end (12) of the tubular body (10), wherein the curved path (C) has a curvature whose radius is R2 = [(9 / 25) x h], with a slope 2 = 45-55°;- a fourth point (P3) located at a distance ds = [(1 / 3) x h] from the distal end (12) of the tubular body (10), wherein the curved path (C) has a maximum curvature whose radius tends to infinity, whose slope is Ps = 20-30°; and- a fifth distal point (P4) located at or near the distal end (12) of the tubular body (10) and having a maximum curvature whose radius tends to infinity.

2. The device (100) of claim 1 , wherein the cross-section perpendicular to the curved path (C) of the tubular body (10) at the first proximal point (Po) is elliptical.

3. The device (100) of claim 1 or 2, wherein the cross-section perpendicular to the curved path (C) of the tubular body (10) at the fifth distal point (P4) is circular.

4. The device (100) of any of the preceding claims, wherein the curved path (C) of the axis defined by the geometry of the tubular body (10) is a non-uniform rational B-Spline (NURBS) type curved path.

5. The device (100) of any of the preceding claims, wherein the tubular body (10) has:- a proximal portion (20) located at or near the proximal end (11) of the tubular body (10), said proximal portion (20) including a fluid inlet member (25) intended, during use of the device (100) with the patient in the supine position, to remain in watertight contact with the female labia minora, the fluid inlet member (25) having, as viewed from a side view, a curved C-shape, with respective radii (RA, RC) at the ends of said C-shape whose value is smaller than the value of the radius (RB) in a central portion of said C-shape;- an intermediate portion (30) intended for internal flow of fluid by decanting; and- a distal portion (40), located at or near the distal end (12) of the tubular body (10), adapted for fluid outlet, for its evacuation.

6. The device (100) of claim 5, wherein it is satisfied that 4 x h = 21 x a, with ( / ?) being a horizontal projection of a length of the curved path of the tubular body (10) and with (a) being a maximum dimension of the fluid inlet member (25).

7. The device (100) of claim 5 or 6, wherein the intermediate portion (30) has an elliptically shaped cross-section.

8. The device (100) of any of the preceding claims, wherein the tubular body (10), is inclined at an angle a= 15-35° with respect to the horizontal, in said position of use.

9. The device (100) of any of the preceding claims, wherein it includes a separation flange (50) coupled to the tubular body (10) or formed integral therewith.

10. The device (100) of any one of claims 5-9, wherein the fluid inlet member (25) is more flexible than the rest of the tubular body (10).

11. The device (100) of any one of claims 5-10, wherein the fluid inlet member (25) has larger dimensions than the rest of the tubular body (10).

12. The device (100) of any one of claims 5-11, wherein the fluid inlet member (25) has an elliptically shaped outer perimeter.

13. The device (100) of any one of the preceding claims, wherein it includes a holding handle (60) coupled to the tubular body (10) or formed integral therewith.

14. The device (100) of any one of the preceding claims, wherein it includes a textured or roughened gripping portion (70) formed on at least an outer portion of the tubular body (10).

15. The device (100) of any of the preceding claims, wherein the tubular body (10) is made of a single piece.

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