Surgery – Body protecting or restraining devices for patients or infants
Reexamination Certificate
2000-08-14
2002-01-01
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
C128S888000, C128S892000
Reexamination Certificate
active
06334443
ABSTRACT:
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 shell means with a concave side facing the user and an opposite convex side, an adhesive area comprising a skin friendly adhesive suitable for long-term adhesive contact with the user's skin, and a fastening means for connecting the shell means with the adhesive area in which the fastening means comprises a connecting part and a first coupling part for connecting to the shell means in a releasable connection to a second coupling part on the adhesive area.
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 bone 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. Development of new and better medicine to prevent osteoporosis can be expected to reduce this rise.
Patients suffering from a fracture of the upper part of the femur often get a reduced quality of life as only about 20% regain full mobility. Moreover, app. 20% die within the first year. 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 also as a device absorbing the energy.
Several devices have been proposed for wearing on the outside of the hip joint for protection against possible injury.
U.S. 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 bed sores.
U.S. 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 83 454 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 hard and slippery floors during bathing and going to the toilet.
EP 99 010 discloses an impact dissipator for the protection of bones and organs of the human body from impacts or falls. The dissipator is bell-shaped and has an outer layer which consists of an elastic rubber substance. Within the shell-like outer layer a viscous fluid layer is located, which is bonded thereto, with the fluid layer forming a skin-friendly adhesive layer adapted to contact and conform to the area being protected.
U.S. 5,062,433 discloses a protector to prevent hip fractures and/or bedsores and/or protect a wound or wound area formed from an outer load bearing member reinforced by internal ridges. The protector is dome-shaped with structured ridges to form an internal dome or clearance for the region of desired protection. A soft inner sheet is attached for comfort.
U.S. 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 U.S. 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 wea
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