WO2003092419A1

WO2003092419A1 - Device for protection against injury

Info

Publication number: WO2003092419A1
Application number: PCT/DK2003/000278
Authority: WO
Inventors: Hans Olsen
Original assignee: Hans Olsen
Priority date: 2002-04-30
Filing date: 2003-04-30
Publication date: 2003-11-13
Also published as: AU2003221471A1; DK200200644A

Abstract

A device (1) for protecting against lesions, mainly bone lesions and especially fracture of the neck of the femur comprising shell means (2) with a connecting part having a first coupling part (20) and trousers (4). The shell means (2) have a concave and a convex side (6, 7). The trousers (4) comprise a second coupling part (19) and a protection band (23) both provided with a centering hole (14) placed theoretically correct. The position of the shell means (2) may be varied horizontally within the limits determined by the difference between the length of the protection band 23 and the horizontal width of the shell means 2 and the difference of the sizes of the coupling parts 19, 20 is foreseen to allow for this variation without compromising the correct interface between the coupling parts. Near the peripheral zone (9) of the shell means (2) is on the concave side (6) permanently fixed the above mentioned connecting part for removable connection of the shell means to the second coupling part 19 of the trousers under the protection band (23). The advantage is that shell means (2) of the device (1) can be placed exactly on the point where the user can feel the bone and during use will be kept in exact alignment with the bone.). Moreover, the product is cheap in use, as the shell means (2) as well as the trousers (4) may be reused with individually replaced counterparts.

Description

Device for protection against injury

FIELD OF THE INVENTION This invention relates to a device for protection against injury, particularly bone fracture and especially fracture of the upper part of the femur, said device comprising a pair of trousers and shell means with a connecting part connecting the shell means with the trousers in which the connecting part comprises fastening means connected to the shell means and a first coupling part for releasable connection to a second coupling part on the trousers.

BACKGROUND OF THE INVENTION

Physical injury to humans may be divided in injury of the bone structure and injury of soft tissue. When protecting against injury of bones it is necessary to direct the forces that could lead to fracture or lesions to the surrounding soft tissue.

It is known that elderly people especially due to deterioration of agility and balance, maybe combined with bad eyesight and insufficient lighting conditions, are more prone to falling. Often the falls of elderly people are of a character leading to long-term hospitalisation due to the complexity of the fracture, osteoporosis and a slower healing process. Some of the types of fractures that elderly people are exposed to have a character that demands insertion of a bone prosthesis in order to get a sufficient mobility. Another aggravating circumstance is that elderly peoples fat tissue and muscles often are not firm or thick enough to function as a shock- absorbing medium in a fall.

In Denmark there are app. 14.000 cases of fractures of the upper part of the femur per year. Operation and care of these patients lead to a total of 300.000 days in bed corresponding to 3-4% of the total occupation of beds in hospitals per year in Denmark. In the next decade a steep rise in the number of fractures of the upper part of the femur is to be expected due to the increasing number of elderly people. However, development of new and better medicine to prevent osteoporosis can be expected to reduce this increase to a certain extent.

Patients suffering from a fracture of the upper part of the femur often get a reduced quality of life as only about 20% regain the same mobility as before the fracture. Moreover, the immobilisation results in a weakening of the general health condition to a degree that leads to the death of app. 20% within the first year from the operation of the fracture. Operation of fracture of the upper part of the femur, the following nursing and rehabilitation and optional relocation from home to nursing home is already costing the Danish society app. 1 billion Danish Kroner per year.

It has been found that the energy absorption around the hip seems to play a greater role in the occurrence of hip fractures than the ultimate strength of the bone itself, which, as a rule, is deteriorating with increasing age. The soft tissue surrounding the hip influences the energy absorption in case of a fall, a fact that partly explains the smaller risk of fracture for obese people.

An effective protection device therefore must act as a means to primarily distribute the energy from the upper part of the femur to the surrounding soft tissue but the protection device also should work as a device for absorbing the energy and provide an extension of the time before all energy from the impact is transmitted to the soft tissue.

Several devices have been proposed for wearing on the outside of the hip joint for protection against possible injury.

US 5,157,789 discloses a hip protective hospital garment, adapted for use by individuals of all sizes, which includes a gown having a lower portion, a pair of upper chest flaps, and a pair of shoulder flaps, wherein the upper chest flaps are adjustably and criss-crossingly connected with the pair of shoulder flaps so as to provide a comfortable, quick, and non-restrictive fit on the individual user. Extending across an interior side of the lower portion is a large, sealable pocket disposed in substantially covering relation to the hips and upper thighs of the wearer, the pocket being structured to receive at least one lightweight, flexible, impact protective air bubble material liner therein so as to provide a protective area that will substantially absorb a force of impact to the hip area of the wearer, and thereby reduce the severity of injuries which may occur from accidental falls. The protective air bubble liner is so situated as to serve the added purpose of reducing risk of stasis ulcers or bedsores.

US 4,737,994 discloses an undergarment to which is applied pocket- forming fabric comprising a pair of portions forming pockets positioned so as to overlie opposite hip regions of the wearer and a connecting portion extending along the waist line of the garment and forming a passage joining the two pockets. An impervious inflatable bag inserted through the entrance into the pockets has an inflatable cushion-forming portion in each pocket and a connecting portion joining the cushion-forming portions. The bag is inserted in deflated condition and is then inflated to provide over each hip region of the wearer an air cushion for cushioning the impact in the event of a fall.

EP 83454 discloses a device to protect a body sensitive to impact or pressure, e.g. the backbone of a two-wheeled vehicle rider or of an athlete. The device is an upholstery comprising several, at least partially uniform, essentially compression-resistant elements expediently in the form of blocks or loops arranged essentially directly adjoining one another and joined flexibly and with high tension strength to one another along their inner surfaces or edges facing the body.

DE 36 38 718 discloses a pair of trousers for medical purpose in which a part around the upper thigh is provided with a pocket in which a covering device with upholstery is placed for protecting against fracture of the upper part of the femur. The hip-protecting device is in the form of a pair of trousers, and must be removed e. g. when bathing or going to the toilet. A lot of hip fractures, around 20%, comes from falling on the often slippery floors during bathing and going to the toilet. US 4, 641 ,641 discloses a protective appliance for the hip joint area comprises an annular pad made of a relatively resilient material and carrying adhesive strips on one surface to secure the pad to the skin, and a relatively rigid dome-shaped shield carried in opposed pockets formed on the other, outer surface of the pad. The shield fits somewhat loosely in the pad pockets to permit it to adjust to changes in body position, thus adding to the comfort of the appliance when it is worn. The sides of the shield disposed between the pad pockets are contoured out of the plane of the pad to add further comfort particularly when the wearer reclines on the appliance.

None of these devices, however, have gained widespread acceptance or have been used to a greater extend. One disadvantage is the mounting, where an accurate location is necessary in order to give a suitable protection. The mounting is often rather troublesome combined with the fact that the devices are not very comfortable to wear. Furthermore there are problems with involuntary removal when e.g. shorts are removed.

In the protection device known from US 4,926,883 an attempt has been made to remedy these drawbacks. This patent discloses a protective body appliance comprising a generally dome-shaped rigid shield secured to a flexible, compressible pad. The pad has an inner section that is adhered to the wearer's body, and an outer section to which the rigid shield is attached. The inner pad section has two lateral wings separated by a centre region all of which form an exposed surface, which is placed against the wearer's body. The inner pad section is mated to the outer pad section along the centre region so that the wings are movable relative to the outer pad section. The wings permit the shield and outer pad section to shift or rock relative to the inner pad section in response to body movements and external forces, thus increasing the appliance's ability to remain adhered to the wearer over time.

The protection device known from US 4,926,883 must be expected to be expensive in use, as the exchangeable parts comprise the complete pad and the complete adhesive part. These parts are furthermore very large as they must extend to and support the end parts and the periphery of the hard shell. The protection device is claimed to allow movement of the hip, but the large pad and adhesive part will be hampering the movement of the skin under the large adhesive area. Furthermore the mounting is rendered difficult by the many different operations to be carried out.

EP 0 802 739 discloses a pair of trousers in which flexible hip protectors of an approximately domed shape are located and fixed in positions confronting the neck of either femur in so-called usual pants so as to cover corresponding portions of the necks of the femurs. Therefore, if a person wears the pants, the hip protectors are always located at exact positions so as to protect the necks of the femurs. Accordingly, the pants with the protectors are effective for wearing the protectors. In this device, the position of the protectors is fixed, even if one variant allows for taking out the protectors for washing the trousers, making it impossible to make adjustments of the position for taking into account the different building of the users or if they, due to incontinence, have to wear diapers. EP 0 727 974 discloses a protective appliance to be worn by an individual for protecting a body part of the individual, which body part is covered by a piece of clothing, includes an inner shell part of a generally convex configuration to be arranged such that one side of the inner shell part is covered by the piece of clothing at the body part of the individual. The inner shell part includes opposite flange members and a central curved member integrally connected to the flange members which have configurations allowing the flange members to be arranged in facial contact with respective body surface parts adjacent to the body part of the individual as the central curved member bridges the flange members so as to cover the body part of the individual without contacting the body part, and as the flange members are arranged in facial contact with the body surface parts. The protective appliance further includes an outer shell part to be arranged opposite to the inner shell part relative to the piece of clothing so as to sandwich the piece of clothing between the inner shell part and the outer shell part, and a fixation part for fixating the inner shell part and the outer shell part relative to one another, sandwiching the piece of clothing therebetween.

In this appliance, the shell parts may be individually adjusted according to the user's needs, but the assembling method stresses and wears the clothing of the device, and elderly people with reduced dexterity may have difficulties in performing this demanding task. The outer shell part is the one having the contact against the skin for distributing the force of a possible blow into the surrounding tissue. The contact area is very narrow and provided with only a very thin soft rubber. This may result in high pressure in a small area resulting in many users experiencing discomfort or pain during use of this protector.

US 6,334,443 discloses a device for protecting a user against lesions, mainly bone lesions and especially fracture of the neck of the femur. The device includes a shell, a fastening structure and an adhesive part. The shell has a concave and a convex side. The adhesive part includes a skin- friendly adhesive suitable for long-term contact with the skin. The fastening structure is fixed near the peripheral zone of the shell on the concave side thereof, and is fixed on the adhesive part inside the peripheral zone of the shell. The fastening of the adhesive part to the first coupling part of the fastening means is done by a non-permanent attachment

Some, especially elderly, users have a problem of locating the protruding part of the femur and thereby ensure a sufficiently accurate placing of the adhesive element for an optimal effect of the protector.

These users need help for handling the system, and others are finding it unpleasant to have an adhesive on the skin or have skin conditions preventing the use of adhesive.

Thus, there is still a need of an efficient hip joint protection being cheap in use, readily placeable and, at the same time, securely staying in place. The protecting device must at the same time not take up too much room and must posses an adequate wearing comfort so that it can be worn or used for extended periods of time or preferably permanently, meaning both day and night. The invention should also provide an opportunity to adapt to the individual body shape and allow for use of incontinence diapers without negatively influencing the protection effect of the device

It is the purpose of the present invention to provide a protection device distributing the forces from the bones, especially the neck of the femur considered the critical area, and absorbing energy to a certain degree.

Furthermore, the protection device must be simply designed and employ a simple fastening principle, so that elderly people can understand the handling of the device by themselves.

The adhesive part must be easy to place and replace accurately on the skin over the neck of the femur, and the area of the adhesive must be made as small as possible so that the overall flexibility of the skin area is as close to natural as possible.

When exposed to an impact, a suitable large area of soft tissue around the neck of the femur should take up the forces.

Furthermore the protection device should be cheap in use, and hence, each part of the device should be reusable with new parts. As people are very different in size it is necessary with several sizes of trousers, possibly four or five sizes, and as there is also a difference in the body shape of the male and the female it will be necessary to have both male and female models. In this way, many will be able to find a size of trousers fitting properly and they will, having the protection shells positioned properly, obtain an acceptable protection.

These standard positions will not cover everybody, as one finds a relatively large difference in the human body shape, e.g. the height of the pelvis region, and also some will use incontinence diapers, leading to the fact that there will still be some people who can not be protected properly with the protection means in a standard setup. In these cases, a possible individual adjustment of the protection means could yield the wanted appropriate positioning and thereby the wanted protection.

The invention relates to a device for protecting against lesions, mainly bone lesions and especially fracture of the neck of the femur comprising a pair of trousers and a pair of shell means readily and independently replaceable.

The trousers comprise on each side of the body aligned with the neck of the femur an outer horizontal protection band having a positioning hole.

The positioning hole is placed theoretically correct aligned with the neck of the femur.

The shell means are in the shape of an oval dome measuring app. 11 by

15 cm and a dome height of app. 2 cm. The shell means comprise a fastening means connecting the shell means releasably with the trousers, in which the fastening means comprises a connecting part and a first coupling part for detachably connecting the shell means with a second coupling part of the trousers.

The second coupling parts of the trousers are permanently secured to the trousers and covers an area aligned with the theoretical position of the neck of the femur.

The horizontal protection bands have lengths substantially greater than the horizontal with of the shell means and are permanently fixed at their horizontal ends to the trousers in separate fixation areas. To reduce the risk of involuntary dismounting of the shell means the height of the horizontal bands makes the bands cover at least a substantial part of the shell means but the bands may be made as high as the height of the trousers. The trousers are in the version shown an elastic unit with a permanent tight fit around the hips. The material may e.g. be cotton containing a proper amount of Lycra® in e.g. 5-10% or cotton with polyester and Elastane®: Many material combinations may be used. It is important that the trousers have a tight fit in order not to be inadvertently displaced during use. However, the fit must not be too tight, as this will make it difficult for a weaker elderly user to put the trousers on or take them off and to place them correctly.

When worn the shell means are totally or at least partly hidden by the horizontal protection band. The height of the protection bands may be made so that they cover only part of the height of the shell means, they may cover the protection means entirely or they may even cover the entire height of the trousers.

The coupling part of the trousers is at least so large as to allow the shell means to be moved enough to account for as well the use of incontinence diapers as the difference in physiognomy of the users. If deemed appropriate for production purposes the size of the coupling part of the trousers may be extended to cover the entire area vertically between the waistline and the end of the trousers legs and horizontally between corresponding ends of the protection band.

A correct placing of the shell means over the coupling part is made easier by a centering hole in the protection band.

The shell means are placed so that the hole in the shell means is aligned with the hole in the protection band. This position will make the shell means be positioned over the neck of the femur on a person with a standard physiognomy.

Corresponding holes in the trousers and the fixed coupling part are aligned with the hole in the protection band. These corresponding holes are used when a placing of the shell means not covered by a standard placing is wanted.

The trousers are put on, preferably without the shell means and, when fitted properly, a mark is placed on the skin through the holes. The trousers are taken off and, by detecting with the fingers while moving the leg the centre of the neck of the femur is determined. The distance between this centre and the marking made through the trousers is the distance that the shell means should be offset. It is now possible to offset the shell means by this distance from the hole in the protection band, and the shell means will then be placed above the neck of the femur of this person. The shell means must be movable up to about 35 mm horizontally and more vertically, if necessary even to a position where they will protrude beyond the lower edge of the trousers.

The invention is characterised in that the connecting part of the fastening means is permanently fixed to the shell means on the concave side hereof near a peripheral zone, that the first coupling part is fixedly connected to the connecting part and placed centrally with respect to the shell means, and that the first coupling part is connected to the connecting part by an area substantially smaller than the area of the first coupling part, and that the second coupling part has a substantially larger area than the first coupling part.

In this embodiment, the shell means and the fastening means will act as an integrated and reusable unit providing the desired good shock- absorbing and impact-distributing function, at the same time being easy for the user to place and remove intently and furthermore being cheap in use, as it is reusable with a new pair of trousers, e.g. when the trousers are worn out. The coupling part on the fastening means is provided with a relatively inelastic lug placed on the edge of the coupling part. The length of the lug is advantageously adjusted so that the outer end of the lug is hidden under the shell means during normal use. In a preferred embodiment the lug is oriented upwards in use. This construction has the effect that, in the case of an unintended pull in the shell means, the forces must be very large to separate the coupling parts, whereas in case of an intended pull in the lug on the coupling part of the fixing means, only small forces are necessary to pull them apart.

It has proven advantageous if the connecting part is elastic as the elasticity reduces the pull in the trousers when the trousers and the shell means move relative to one another. The shell means may be provided with a larger centrally placed hole and the fastening means provided with an 8 to 10 mm hole in the fastening area of the corresponding coupling part for aiming purposes. This permits an easy and precise placing of the shell means aligned with the hole of the protection band. The pressure necessary for coupling is easily established, e. g. with a finger through the hole in the shell means, against the coupling parts, which are thereby connected.

In this way it is achieved, that the protection device in use, during moving and normal shifting of posture always is placed opposite the point of the bone considered the most critical, and the shell means can, due to the precise placing, perfectly distribute the load through the foam edge into the surrounding soft tissue.

With this division of the shell means and fastening means as first reusable part and trousers with protection bands as a second reusable part, a system is provided which is, at the same time, effective and cheap in use.

According to the invention, the fastening areas of the connecting part may be provided in two diametrically opposed areas of the shell means, preferably along the axis of the largest extension of the shell means. The connecting part is permanently fixed to the shell means, e.g. with adhesive, rivets or by welding.

According to the invention, the trousers may comprise a coupling part, which coupling part may comprise a hook or loop layer, snap fasteners, adhesive or magnets so that a detachable attachment may be achieved between the fastening means and the trousers.

The shell means must be made from a relatively rigid material, e. g. acrylic, PMMA, having a tensile module around 3300N/mm². A suitable thickness would be about 3 mm. Other plastic materials may be used, e. g. polycarbonate, PC, being a little less rigid but much more impact resistant the acrylic.

Still further, according to the invention, the peripheral zone of the shell means may be curved in such a manner that it forms a convex surface facing the user, which convex surface is sufficiently large to distribute the impact forces induced by a fall along the periphery of the shell means. To improve the comfort and in order for allowing the use of the device around the clock, i. e. also during sleeping, the part of the peripheral zone of the shell means facing the skin may be provided with a thick foam body. The foam body may be extended to cover the edge of the shell means.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is explained in more detail with reference to the drawings in which

Fig. 1 shows in perspective the hip protection device according to the invention viewed from the side.

Fig. 2 shows the shell means according to the invention

Fig. 3 shows a section of the shell means along the line A-A in Fig. 2

Fig. 4 shows the shell means viewed in a section along the line B-B indicated in Fig. 1.

DETAILED DESCRIPTION OF THE DRAWINGS Reference is made to the drawings, which show a protection device in the form of a hip protector 1. The protection consists of two individual units, the trousers 4 and the shell means 2. One unit, the trousers 4, are provided with a protection band 23 and a second coupling part, not shown I fig. 1. Fig. 2 shows the shell means 2 of the invention seen in perspective provided with a connecting part 3 and venting holes 15.

Fig 3 shows the shell means 2 seen in a section along a line A-A in Fig. 2 with the connecting part 3 comprising the first coupling part 20 and the convex peripheral part 9 provided with a foam body 5. In the middle, the shell means 2 are provided with a hole 8 and has a generally convex side 7 and a generally concave side 6.

Fig 4 shows the hip protector in a section along the line B-B of Fig. 1 comprising:

The shell means 2 with connecting means 3 and the trousers 4 with the protection band 23. The connecting means are shown with an elastic band 22 fastened to the shell means 2 in opposed areas 12. The connecting means 3 has a first coupling part 20 fixed to the elastic band 22 in an area 13. The first coupling part 20 and the second coupling part 19 on the trousers are in this figure shown before connecting. The connecting part 3 is provided with a lug 21 and a hole 11. Furthermore, the figure shows alignment holes 14 through the protection band 33, the second coupling part 19 and the trousers 4.

In the embodiment shown, the trousers 4 work as an elastic unit permanently fitting tightly around the hips of the wearer, thereby ensuring that the protections means are not inadvertently displaced.

When worn the shell means 2 are totally or partly covered by the protection band 23 which are fastened to the trousers 4 in two separate fastening areas 24, 25 having a distance significantly greater than the smallest width of the shell means 2, thereby allowing an off centre placing of the shell means. The coupling part 19 of the trousers is permanently fixed to the trousers 4 aligned with the neck of the femur and the shell means 2 are releasably connected to the coupling part 19. The purpose of the protection band 23 is to prevent or at least reduce the risk of involuntary dismounting of the shell means 2 and the height may be from only covering the shell means 2 partially to the entire height of the trousers 4.

The second coupling part 19 is at least large enough to allow for the above mentioned off-centre placing of the shell means 2 while still keeping the full interface between coupling parts 19, 20 for adapting to the user's physiognomy or for wearing incontinence diapers. The size may, for e. g. production reasons, be extended to cover the entire area between the waist and the end of the trousers' leg and the two fastening areas 24,25 of the protection band.

Holes 11 , 14 are provided in all of the elements for easing the centering of the units when placed in a standard position and may conveniently be used also for controlled off-centre placing of the shell means 2 in the way described above.

In the embodiment shown, the shell means 2 is shaped like an oval shell measuring e. g. 11 by 15 centimetres and dome-shaped with a height of app. 2 centimetres.

Proximate to the peripheral zone 9 on the concave side 6 of the shell means 2 the connecting part 3 is fastened to the shell means 2 with one or more permanent fastenings 12. The fastening may be done with an adhesive, by rivets or by welding.

The connecting part 3 comprises in the embodiment shown an elastic band, on which, approximately in the middle is fixed permanently the first coupling part 20, comprising in the embodiment shown a burr-like material. The fixing area 13 between the elastic band and the coupling part 20 is significantly smaller than the area of the coupling part 20, meaning that pulling forces do not attack at the edge of the coupling incurring that the coupling parts 20 and 19 can not be peeled apart when pulling in the connecting part 3 via the shell means 2.

The coupling part 19 comprises a loop-like material. The coupling parts 19 and 20 may also be made with adhesive or magnets.

The coupling part 19 on the trousers 4 is larger than the coupling part 20 of the fastening means 22.

With this construction it is achieved, that at all times when pulling in the shell means 2, the pulling forces attack at a distance from the edges of the individual parts of the system, and that consequently a large force is necessary if the two coupling parts 19 and 20 are to be separated by accident.

The suspension or connecting part 3 is preferably made from a broad elastic band, in which the pre-tension is adjusted according to the fact, that the shell means 2 must be able to move and follow the skin when moving, e. g. when changing from a standing to a sitting position, so that the shell means always will cover the neck of the femur.

The connecting part 3 is in the embodiment shown permanently fixed to the shell means 2. The permanent fixing 12 between the shell means 2 and the connecting part 3 is in a more preferred embodiment in the form of two areas placed diametrically opposed on the shell means, preferably longitudinally to the largest extension of the shell means.

In the embodiment shown in Fig. 4, the fixing points 12 between the connecting part 3 and the concave side 6 of the shell means 2 are shown. The convex side of the shell means is marked 7.

The fixing of the adhesive means to the skin must take place exactly over neck of the femur. In order to carry out this as precisely as possible, the adhesive means preferably is provided with a hole 14 for marking and alignment. The connecting part 3 preferably is provided with an alignment hole 11 in the fixing area 13, i. e. the alignment hole 11 goes through the connecting part 3 as well as the coupling part 20.

The change of radius of curvature in the peripheral zone 9 of the shell means 2 in a more preferred embodiment causes the peripheral zone 9 to have an increased area of contact against the skin outside the area in which the neck of the femur is situated. In this way a pressure, e.g. arising from sleeping with the shell mounted, is dispersed to the surrounding soft tissue via a wide surface. The peripheral zone 9 of the shell means 2 may also in a more preferred embodiment be provided with a foam body or soft rubber lining 5, e. g. a semi-hard foam or soft rubber, to obtain a softer contact with the skin, when the shell means 2 is subjected to a load. To ensure an easy intentional removal of the shell means 2 and the connecting part 3 when so desired, a more preferred embodiment has a dismounting lug 21 positioned on the edge of the coupling part 20 of the connecting part 3. In a more preferred embodiment the lug 21 is placed so that in normal use it will point upwards and as a whole be inside the periphery of the shell means.

The shell means 2 may, apart from the centrally placed hole 8, be provided with a number of smaller holes 15 to ensure ventilation.

Claims

1. A device (1) for protecting against lesions, mainly bone lesions and especially fracture of the neck of the femur comprising: A pair of trousers (4) provided with a protection band (23) and shell means (2) having a concave side (6) facing the user when mounted and an opposite convex side (7), and a connecting part (3) connecting the shell means (2) with the trousers

(4), in which the connecting part (3) comprises a first coupling part (20) for detachably connecting the shell means (2) with the second coupling part (19) on the trousers (4), CHARACTERISED IN THAT the connecting part (3) is permanently fixed to the shell means (2) close to a peripheral zone (9) on the concave side (6) hereof , and that the first coupling part (20) is fixedly connected to the connecting part (3) and is placed centrally with respect to the shell means (2), that the first coupling part (20) is connected to the connecting part (3) via an area (13), which is substantially smaller than the area of the coupling part (20), that the second coupling part (19) has an area substantially larger than the first coupling part (20), that said protection band (23) is at least partly covering said shell means (2), when said device (1) is in use and is fastened to said trousers (4) in two separate fastening areas (24, 25), said fastening areas having a distance substantially larger than the width of said shell means.

2. A device (1 ) for protecting against lesions according to claim 1 , CHARACTERISED IN THAT Said area difference between the couplings (19, 20) corresponds at least to said difference between said width of said shell means (2) and said distance between said fastening areas (24, 25) to enable a correct engagement between said coupling parts (19, 20) in an off-centre position of said shell means

3. A device (1 ) for protecting against lesions according to claim 1 or 2, CHARACTERISED IN THAT said off-centre position may be up to 35 mm horizontally offset to either side.

4. A device (1 ) for protecting against lesions according to claim 1 , 2 or 3, CHARACTERISED IN THAT said first coupling part (20) and said second coupling part (19) are in the form of co-operating coupling means like a burr- or hook device and a nap- or loop device, magnets or adhesives.

5. A device (1 ) for protecting against lesions according to claim 1 , 2, 3 or 4,

CHARACTERISED IN THAT said trousers (4), said second coupling part (19) and said protection band (23) are provided with aligned marking holes (14), preferably less than 10 mm in diameter.

6. A device (1 ) for protecting against lesions according to any of the preceding claims,

CHARACTERISED IN THAT said connecting part (3) has elastic properties, preferably in the form of an elastic band.

7. A device (1 ) for protecting against lesions according to any of the preceding claims,

CHARACTERISED IN THAT the shell means (2) is made as an oval dome and that the connecting part (3) is secured to the shell means (2) in two diametrically opposed areas (12) on the shell means, preferably aligned with the largest dimension of the shell means.

8. A device (1 ) for protecting against lesions according to any of the preceding claims, CHARACTERISED IN THAT said connecting part (3) is provided with a small alignment- and marking hole (11) having a diameter preferably smaller than 10 mm.

9. A device (1 ) for protecting against lesions according to any of the preceding claims,

CHARACTERISED IN THAT the peripheral zone (9) of the shell means (2) is curved in a way, that it forms a concave surface facing against the concave surface (6) of the surface of the shell means (2), and a convex surface facing the user which convex surface is sufficiently large for dispersing the pressure following a fall along the peripheral zone (9) of the shell means (2).

10. A device (1) for protecting against lesions according to any of the preceding claims, CHARACTERISED IN THAT a ring-shaped elastic foam body (5) is fastened on the convex surface of the peripheral zone (9) facing the user and around the edge of the shell means (2).

11.A device (1 ) for protecting against lesions according to any of the preceding claims,

CHARACTERISED IN THAT a pulling lug (21) is placed on an edge of the coupling part (20) of the connecting part (3).

12. A device (1 ) for protecting against lesions according to any of the preceding claims,

CHARACTERISED IN THAT the pulling lug (21 ) in normal use is pointing upwards and as a whole is lying inside the periphery of the shell means.