A protective device for monorenal subjects or subjects with renal disease

Abstract

There is described a protective device (1) for monorenal subjects or subjects with renal disease, comprising : - a garment (2) wearable by a subject (P) at least at a lumbar region (L) of the subject (P), - at least one protective element (4) installed on said garment (2) at a portion thereof configured to be positioned at the lumbar region (L) of the subject (P) when the garment (2) is worn by the subject (P), - a belt element (6) configured to at least partially encircle the torso of the subject (P) in the lumbar region (L) and to exert a compressive action of the at least one protective element (4) against the lumbar region (L) of the subject (P).

Description

[0001] "A protective device for monorenal subjects or subjects with renal disease"

[0002] ★ ★ ★ ★

[0003] DESCRIPTION

[0004] Field of the Invention

[0005] Children, teenagers and young adults who were born with a single kidney ( a situation defined as renal agenesis or solitary kidney) , or who develop an acquired solitary kidney condition due to surgery (nephrectomy, i . e . kidney removal surgery, e . g . because of a tumour ) or due to disease ( solitary functioning kidney) are at a risk of completely losing the (vital ) renal functionality i f the remaining kidney is subj ected to damage due to a trauma . The most common situations which may bring about a severe kidney damage are road, bicycle or motorcycle accidents , or accidental traumas during sport or recreational activities which involve a contact or a collision with another participant or against an obj ect ( e . g . mountain bike , rugby, football , hockey, skiing, skating, horse-riding and, less frequently, soccer, basketball and volleyball ) .

[0006] The most frequent situation causing the acquired loss of a kidney in children and teenagers is a kidney tumour . For the children, the teenagers and the young adults who have survived a kidney tumour, the possibility of freely and constantly participating in physical activities is considered by the World Health Organi zation a vital requirement for a satis fying physical and mental health of the subj ect .

[0007] The obj ect of the present invention aims at providing a tool which enables a monorenal subj ect , as well as all the subj ects who have been cured from a kidney tumour, to practice recreational or sport activities , beside some everyday activities , in complete safety, by limiting the risks connected to severe traumas on the only kidney remaining . Estimates indicate that approximately 1 child out of 2000 is born with a solitary kidney, and that approximately 1600 new cases of kidney tumour in pediatric age are diagnosed every year in Europe and in the USA.

[0008] Moreover, in 2020 as many as 431 , 288 new cases of kidney tumour in adults have been estimated : such a situation leads to a surgically acquired solitary kidney, and this highlights the fact that the problem concerns subj ects of every age .

[0009] No ef fective solution is known to this problem ( apart from primary prevention, i . e . preventing monorenal subj ects from practicing risky activities ) ; in other words , there are no protective devices which monorenal children, teenagers and young adults may wear during the recreational or sport activities which are most likely to be associated with the risk of a kidney trauma .

[0010] Although it is di f ficult to quanti fy the risk of a genito-urinary trauma which is so severe as to cause the loss of a kidney, such an event is neither foreseeable nor evitable in the absence of protections , and it is a maj or obstacle which prevents monorenal subj ects from practicing recreational and sport activities in safe and carefree conditions . In the absence of a kidney protective device which is ef fective and minimally intrusive , which does not hamper the freedom of movement of the subj ect , to this day the health professionals and the authorities responsible for issuing medical certi ficates of fitness for competitive sports have no choice but to evaluate each case individually, and possibly to prohibit the participation in competitive sports which involve contact or collision .

[0011] Obj ect of the Invention

[0012] The invention aims at solving the technical problems outlined in the foregoing. Specifically, the aim of the invention is to enable monorenal subjects to practice sport activities in safety, even when such activities imply a contact or a collision, without precluding the enjoyment of such activities, i.e. without imposing a protective equipment which may hinder the subject's mobility.

[0013] Summary of the Invention

[0014] The object of the invention is achieved by means of a device having the features outlined in the claims that follow, which form an integral part of the technical disclosure provided herein in relation to the invention.

[0015] Brief Description of the Figures

[0016] The invention will now be described with reference to the annexed Figures, which are provided by way of non-limiting example only and wherein:

[0017] - Figure 1 is a schematic front view of a human figure wearing a device according to the invention (see arrow I of Figure 3) ,

[0018] - Figure 2 is a schematic rear view of the human figure of Figure 1, wearing the device according to the invention (see arrow II of Figure 3) ,

[0019] - Figure 3 is an axial section view according to line III-III of Figure 1,

[0020] - Figure 4 is a sagittal section view according to line IV-IV of Figure 1,

[0021] - Figure 5 and Figure 6 show possible configurations of a component of the device according to the invention, and

[0022] - Figure 7 shows a further aspect of the device according to the invention.

[0023] Detailed Description

[0024] Reference 1 in Figures 1 to 4 generally designates a protective device for (surgically or functionally) monorenal subjects according to the invention. The protective device 1 generally comprises a garment 2 wearable by a subject at least at a lumbar region L of the subject, at least one protective element 4 installed on the garment 2 at a portion thereof configured to be positioned at the lumbar region L of the subject when the garment is worn by the subject, and a belt element 6 configured to encircle, at least partially and preferably fully, the torso of the subject in the lumbar region L, and to exert a compressive action of the protective element 4 against the lumbar region L of the sub j ect .

[0025] Positioning the protective element 4 at the lumbar region L enables the same to act as a bumper, by absorbing and dissipating, without causing traumas to the subject, the energy deriving from possible impacts in the lumbar region L, where the kidney (s) of the subject is / are located. With reference to figures 1, 2 and in particular figure 3, it can be observed how in a preferred embodiment the extension of the protective element 4 at the lumbar region L is so as to cover the waist of the subject, thereby protecting the subject from lateral or oblique traumas.

[0026] The garment 2 is preferably an undergarment, particularly - with reference to the embodiment depicted in the Figures - a bodysuit. Of course it is possible to vary the style according to needs, so that the embodiment in the Figures, combining the shape of boxer shorts and the shape of a sleeveless vest, may be implemented in a different style, e.g. a short-sleeved or long-sleeved vest and high-cut briefs, or short or long trousers. Preferably, the garment 2 is made of a stretchy fabric (e.g. Lycra®) so as to closely adhere to the body of the subject P, therefore avoiding undesirable movements of the protective element 4 with respect to the body of the subject P. As an alternative, it is possible to implement the garment 2 as an undergarment which does not cover the torso, but which is shaped as high-waist pants or trousers, in such a way as to support to and / or to house the at least one protective element 4 at the lumbar region L when it is worn by subject P.

[0027] Preferably, with reference to Figures 3 and 4, the garment 2 comprises a pocket 2P provided at the portion thereof configured to be positioned at the lumbar region L of the subject when the garment 2 is worn by the subject P. The pocket 2P houses the at least one protective element 4. Preferably, the pocket 2P is an open pocket, thus enabling the insertion and the removal of the protective element 4 according to needs, e.g. in order to wash the garment 2 after the sport activity. In preferred embodiments, the pocket 2P comprises an opening which is closable, e.g. by means of a zip, a strip of Velcro® or a series of snap fasteners or buttons, wherein the closable opening is configured for the insertion and the extraction of the at least one protective element 4. In other embodiments, the pocket 2P may be configured as a closed perimeter pocket, i.e. wherein the at least one protective element 4 is permanently housed within the pocket 2P. In such embodiments, the pocket 2P is made during the manufacturing of garment 2, and the perimeter is sewn or otherwise closed (in the case of a synthetic fiber garment 2, the closed perimeter may be obtained by heat sealing) directly around the protective element 4.

[0028] Preferably, the pocket 2P is provided at an external surface of garment 2, i.e. a surface which does not contact the subject's skin. This configuration is visible in Figures 3 and 4: the protective element 4 contacts the external surface of the garment 2 and a cover of fabric - made either of the same material as element 2 or of a different fabric, e.g. Nylon® or Cordura® .

[0029] However, embodiments are possible wherein the pocket 2P is pos itioned on an inner surface of garment 2 ; in such cases , it is preferable to use a cover of the same fabric as garment 2 in order to implement the pocket 2P .

[0030] However, it must be borne in mind that the pocket 2P is not strictly necessary : the at least one protective element 4 may be applied directly to the fabric of garment 2 , e . g . by sewing along a perimeter flange of the protective element 4 : the stitching traverses the perimeter flange and the fabric of garment 2 in the lumbar region L, thereby fixing the protective element 4 to the garment 2 . Moreover, it is possible to provide the protective element 4 of a back part j oined by stitching, glueing of welding, and the back part may be provided with a coupling tape which mates with a corresponding coupling tape being sewn or applied onto an external surface of garment 2 , wherein the coupling tapes implement a loop-and-hook connection such as Velcro® . In the latter case , the ( at least one ) protective element 4 may be removed from garment 2 .

[0031] In other words , the pocket 2P is not strictly necessary, because the ( at least one ) protective element 4 is required to extend around the torso of the subj ect , in such a way as to encircle a region of the lumbar area L whereat there are located a right kidney RK and a left kidney Lk, or either of them in the case of proper monorenal subj ects .

[0032] As regards the belt element 6 , it may be implemented as a band or belt of a material which may be stretchy or substantially resistant to traction, extending at least for the same length of the at least one protective element around 4 around the torso of the subj ect P . In this way, it is possible to position the belt element 6 in such a way as to exert a radial compressive action by the protective element 4 against the lumbar region L of the subj ect , therefore further limiting the movement of said element 4 . Preferably, the belt element 6 is configured to fully encircle the torso of the subj ect ( Figure 3 , Figure 4 ) and it comprises free ends which may be coupled by means of a connection 6F, which may comprise a pair of loop-and-hook tapes , such as Velcro®, a buckle ( such as used for trousers belts , or else a sel f-locking buckle as used in backpacks ) , or else a so- called "double D" buckle , as used in the chin straps of motorcycle helmets . The solutions envisaging a buckle which are mentioned in the present description may be used when the protective device 1 is employed in sport activities wherein the contact occurs not with another person but with a moving obj ect , such as e . g . a tennis ball .

[0033] Whatever the implementation of connection 6F, as shown in Figures 3 and 4 , there is provided an overlapping area between the free ends , so as to enable the coupling thereof and the consequent tensioning of the belt element .

[0034] Advantageously, the belt element 6 is provided with one or more loops 8 which are sewn or otherwise attached on the undergarment 2 , through which the belt element 6 is arranged . The loops help the subj ect in the correct positioning of the belt element 6 , guaranteeing an optimal radial compression onto the protective element 4 .

[0035] In the embodiments wherein the belt element 6 does not fully encircle the torso of the subj ect P, the belt element may be configured as a band which may overlap the protective element 4 and may be fixed in a tensioned condition to the garment 2 by means of Velcro®, buttons , or a buckle . In an embodiment , an end of the belt element may be sewn or otherwise attached to the garment 2 in a position circumferentially external to the surface of element 4 , the opposite end being attachable - while tensioning the belt element 6 - in a position with is equally circumferentially external to the surface of the protective element , but which is opposed to the first end . Again, the fixation may be achieved by means of Velcro®, buttons , a buckle , etc .

[0036] With reference to Figures 5 and 6 , there will now be described some preferred configurations of the protective element 4 . As can be seen in these Figures , the protective element 4 is preferably configured as a flexible plate , adapted to conform to the lumbar region of the subj ect and having a texture with an auxetic structure . Figure 5 shows a protective element 4 which has an auxetic structure with sinusoidal grating, while Figure 6 shows a protective element 4 having an auxetic structure with a bidimensional re-entrant grating . Of course , Figures 5 and 6 show two possible examples , but other known auxetic textures may be employed as well . Preferably, whatever the auxetic texture may be, the protective element 4 comprises a non-Newtonian fluid, the response whereof to deformation, depending on the speed of the deformation, optimizes the properties of kinetic energy absorption of said element 4 . Again preferably, and not necessarily linked to the implementation of the protective element with an auxetic structure (hence what follows applies both to the protective element 4 made as a " solid" slab free of auxetic texture or as a slab with auxetic texture ) , a material that can be used for the implementation of the protective element 4 comprises a non-Newtonian fluid with density comprised between 0 . 2 g / cm3and 1 . 2 g / cm3and thickness comprised between 2 mm and 10 mm, with peak value of the transmitted force lower than 10 kN in the impact test ( according to UNI EN 1621 ( 10J) ) for a slab having a thickness of 6mm .

[0037] Although the preferred embodiments - shown in Figure 3 - envisage one single protective element 4 extending along an arch which covers at least the left kidney LK, the paravertebral muscles PM and the spinal column SC, and the right kidney RK of subj ect P, it is however possible to envisage embodiments wherein the protective device 1 comprises more than one protective element 4 , for example two distinct elements arranged at the right and at the left kidney RK and LK, or else three distinct elements arranged at the kidneys RK, LK and at the spinal column SC (visible in Figure 3 ) , while also implementing a partial coverage of the paravertebral muscles PM . Whatever the number of elements 4 , they may have the same auxetic structure , or else they may have di f ferent auxetic textures selected on the basis of the anatomical site whereat the element 4 is located when the garment 2 is worn . For example , embodiments may be envisaged wherein the auxetic structure is the same at the kidneys RK, LK, while it varies at the spinal column SC and / or at the paravertebral muscles PM . This may apply both to the case of three separate elements 4 and to the case of a single element 4 , which in the latter case exhibits an auxetic structure which varies along the extension thereof .

[0038] Finally, with reference to Figure 7 , the protective device 1 may be provided with equipment sensing the intensity of the blows encountered during the sport activity, so that , at the end o f such activity, the subj ect may inform a physician about the stresses he has undergone , and the physician may consider possible further diagnostic inquiries . For example , it is possible to apply a film 10 responsive to pressure on the side of the protective element 4 facing outwards of the subj ect ' s body . The film 10 may be applied by adhesive means and may be removed after each use , replacing it with a new film 10 . An example of such a film comprises the product having the commercial name "Prescale" , manufactured by Fuj i film .

[0039] Thanks to the device 1 according to the invention, it is possible to of fer to every monorenal subj ect an extremely ef fective and safe support for sport activities involving contact ( and for other activities ) , thereby preventing renal or urinary inj uries which are potentially critical for the subj ect . The device 1 is easy to use and to wear, as it substantially corresponds to a so-called "technical" undergarment . The subj ect must simply tension the belt element 6 , so as to apply a radial compression on the protective element 4 , thereby fixing the position thereof with respect to the lumbar region L . The structure and the material of the protective element 4 absorb any blow which may be potentially harmful to the kidneys RK and / or LK, and dissipate the kinetic energy thanks to the auxetic structure and / or the implementation by means of a nonNewtonian fluid .

[0040] Of course , the implementation details and the embodiments may vary, even appreciably, with respect to what has been described and illustrated, without departing from the extent of the present invention as defined by the annexed claims .

Claims

CLAIMS1. A protective device (1) for monorenal subjects or subjects with renal disease, comprising:- a garment (2) wearable by a subject (P) at least at a lumbar region (L) of the subject (P) ,- at least one protective element (4) installed on said garment (2) at a portion thereof configured to be positioned at the lumbar region (L) of the subject (P) when said garment (2) is worn by said subject (P) , a belt element (6) configured to at least partially encircle the torso of the subject (P) in the lumbar area (L) and to exert a compressive action of the at least one protective element (4) against the lumbar area (L) of the subject (P) .

2. The protective device (1) according to claim 1, wherein the garment comprises a pocket (2P) provided at the portion thereof configured to be positioned at the lumbar area (L) of the subject (P) when the garment (2) is worn by the subject (P) , the pocket (2P) housing said at least one protective element (4) .

3. The protective device (1) according to claim 2, wherein said pocket (2P) is an open pocket.

4. The protective device (1) according to claim 3, wherein said pocket (2P) comprises a closable opening, said opening being configured for insertion and extraction of said at least one protective element (4) .

5. The protective device (1) according to claim 2, wherein said pocket (2P) is a closed perimeter pocket, wherein said at least one protective element (4) is permanently housed within said closed perimeter pocket (2P) .

6. The protective device (1) according to any one of the preceding claims, wherein said belt element (6) is configured to fully encircle the torso of the subject.

7. The protective device (1) according to any one of the preceding claims, wherein said garment (2) is an undergarment, in particular a bodysuit.

8. The protective device (1) according to claim 1 or claim 6, comprising one or more loops (8) through which said belt element (6) is arranged.

9. The protective device (1) according to any one of the preceding claims, wherein said at least one protective element (4) is a plate with a texture having an auxetic structure.

10. The protective device (1) according to claim 1 or claim 9, wherein said at least one protective element (4) comprises a non-Newtonian fluid.

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