Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2000-07-20
2003-01-14
Brown, Michael A. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
C602S042000, C602S052000, C602S054000
Reexamination Certificate
active
06506957
ABSTRACT:
The invention relates to a self-adhesive shaped body, also referred to as a cushioning pad, and possessing high resilience, for orthopaedic purposes, especially for prophylaxis, postoperative treatment and therapy, especially for more rapidly reestablishing the function of injured joints, such as knee, ankle, shoulder, elbow and/or wrist joints.
BACKGROUND OF THE INVENTION
The bandaging of joints, for example following injury or in the case of degenerative disorders, is a known method of orthopaedic treatment. The spectrum ranges from simple winding with more or less elastic bandages, through ready-made bandages in a wide variety of embodiments, and on to braces and splints of complex construction.
Additionally, the functional dressing technique, known as taping, is a treatment method for the prophylaxis and therapy of injuries, diseases and alterations on the locomotor apparatus. The purpose of taping is to mimic the capsular ligament structures and so achieve selective support and stabilization.
The actual tape dressing is applied in strips comprising preferably inelastic self-adhesive bands, known as straps, or in conjunction with self-adhesive bands having short-pull elasticity. It protects, supports and relieves vulnerable, damaged or disrupted parts of a functional unit. It permits selective loading within the pain-free sphere of movement, but prevents extreme or painful movements.
The application of such dressings, however, requires expert skill and experience and, consequently, cannot in general be performed by non-experts without taping experience.
A large number of bandages are known which aim to reestablish the function of injured joints.
EP 0 027 172 A1 describes a bandage in tube form for supporting and/or compressing knee, ankle, elbow and/or wrist joints. An adhesive coating of the bandage is not described.
An epicondylitis bandage is disclosed by EP 0 250 409 A1. An epicondylitis bandage of this kind consists essentially of a tube section comprising elastic material, the tensile stress in the peripheral direction being alterable by way of a tensioning strap which extends essentially in the peripheral direction and has a closure. The bandage is not self-adhesive.
DE 41 01 965 A1 discloses a joint bandage comprising elastic bandage material with a soft and a hard component and at least one friction core. Self-adhesive properties are not described. The joint bandage permits targeted transverse frictional massage for the more rapid reestablishment of the functions of injured joints such as knee, ankle, elbow, shoulder and wrist joints and has an insert which in the applied state acts on the joint and is designed as a compression cushioning pad, this pad having a form determined by the bone projections and tendon insertions of the joint and, as a shaped body, being formed from a soft or soft-elastic material in which at least one friction core comprising a hard or incompressible material is arranged and is fixed in its position in the material of the shaped body.
DE 42 37 389 A1 describes a knee joint bandage having corresponding anatomical forms. Self-adhesive properties are not described. The bandage for overcharge phenomena, femoropatellar pain syndromes and the patella tip syndrome, comprising an elastic bandage material in tube form with an encircling insert comprising a wavy knit, possesses, in the front part of the bandage, a cushioning pad which is situated in the region over the patella with the bandage applied, is upwardly open and leaves the quadricipital tendon free, and, in the rear part of the bandage, one or two cushioning pads which are arranged at a distance from one another and which act on the insert of the ischiocrural musculature.
It is an object of the invention to provide an anatomically designed shaped body for orthopaedic purposes which on the basis of the self-adhesive properties adheres to the skin or to an underlaid material, whereby owing to the high resilience of the shaped body when correctly applied a massage effect is established which leads to a more rapid reestablishment of the function of injured joints, such as knee, ankle, shoulder, elbow and/or wrist joints. In addition, the shaped body ought to improve the proprioceptive effect.
SUMMARY OF THE INVENTION
This object is achieved by means of a self-adhesive shaped body which is adapted to the anatomy and has a proprioceptive effect and is intended for medical purposes, as is described in the main claim. The subsidiary claims depict advantageous embodiments of the invention.
Accordingly, the invention provides a self-adhesive shaped body which is adapted to the anatomy, has a proprioceptive effect and is intended for medical purposes, having
a bond strength of from 1 N/cm to 25 N/cm,
an extensibility of more than 10%,
a thickness of more than 0.5 mm and
a resilience of more than 50% for a tensile stress of 5 N/cm
2
.
The shaped body of the invention is based on a composition which is designed so as to be self-adhesive by virtue of appropriate process steps or formulation with tackifiers.
To significant extents the body comprises an elastic polymer selected from the group consisting of polyurethane, polyester, polyether, polyepoxide, polyolefin and/or an elastic polymer based on a natural or synthetic rubber.
The technical properties of the shaped body may be adjusted depending on the field of use. In some cases, strongly adhering systems, or else less pressure-sensitive adhesive systems, are required for the shaped body. To this end, appropriate additives such as tackifier resins, plasticizers, stabilizers and other auxiliaries may be added to the respective system.
Advantageous embodiments exhibit a bond strength of from 1.5 to 22 N/cm, with particular preference from 1.5 to 18 N/cm. In one specific embodiment for the knee the bond strength is 14.5 N/cm. In another specific embodiment, for the elbow, the bond strength is 16.0 N/cm.
In one particularly preferred embodiment, the composition used to produce the shaped body is a thermoplastic hot-melt composition. The softening point of the thermoplastic hot-melt composition should be greater than 50° C., since the application temperature in the course of production is generally at least 70° C., preferably between 90° C. and 190° C. If desired, postcrosslinking by means of UV or electron beam irradiation may be appropriate. This depends on the chosen structure of the parent polymer or its additives.
The blending of block copolymers based on SEPS and SEBS for producing a shaped body of the invention, in particular, is notable for its diverse possibilities for variation. For particularly strongly adhering systems, the cohesive adhesive composition is based preferably on diblock (A-B) or triblock (A-B-A) block copolymers and/or mixtures thereof, preference being given to a diblock copolymer fraction of less than 80% by weight. The hard phase A is ideally polystyrene or its derivatives, and the soft phase B comprises ethylene and propylene and/or butylene or mixtures thereof.
The chain of the phase B may also include fractions of other kinds, such as, for example, isoprene, butadiene or similar substances. However, polystyrene blocks may also be present in the soft phase B, in proportions of up to 20% by weight. The overall styrene content, however, should always be lower than 65% by weight, preferably less than 40% by weight, with particular preference from 3 to 35% by weight. Preference is given to styrene fractions of between 3% by weight and 35% by weight, since a lower styrene fraction makes the adhesive composition more conforming.
In one advantageous embodiment the adhesive composition is composed as indicated below:
from 5% by weight to 90% by weight
of block copolymers,
from 5% by weight to 80% by weight
of tackifiers such as oils, waxes,
resins and/or mixtures thereof,
preferably mixtures of resins and
oils,
less than 60% by weight
of plasticizers,
less than 15% by weight
of additives and
less than 5% by weight
of stabilizers.
The aliphatic or aromatic oils, waxes and resins used as tackifiers are preferably hydrocarbon oils,
Herzberg Thorsten
Himmelsbach Peter
Beiersdorf AG
Brown Michael A.
Hamilton Lalita
Norris & McLaughlin & Marcus
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