Casting material

Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace

Reexamination Certificate

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Details

C602S005000, C602S008000, C602S019000

Reexamination Certificate

active

06673030

ABSTRACT:

Plaster of Paris bandages are well known in the art and are generally employed for arthopaedic applications such as casting and splinting.
Plaster of Paris casts however are sensitive to water and patients wearing Plaster of Paris casts have to avoid rain and can not shower.
Polyurethane resin based casts have to some extent alleviated this problem as they are waterproof, however their cost is prohibitively expensive for many people. It is also an advantage to still use Plaster of Paris casts when the injured limb being protected by the casts is likely to swell as a Plaster of Paris cast can be disintegrated by submerging in water.
Thus it is desirable to develop a water resistant Plaster of Paris cast or splint that would overcome or at least inhibit disintegration of the Plaster of Paris in damp or wet conditions.
In the prior art many solutions have been sought, such as painting the cast after application to a patient with a waterproofing material. This however involves a second step.
The addition of a water resistant agent to the Plaster of Paris during the manufacturing process was previously anticipated that it would interfere with the adhesion of the Plaster of Paris to the substrate and also with the setting process of the Plaster of Paris.
Surprisingly we have found however that the application of a thin water resistant film on at least one side of the bandage results in a material that can be wetted as well as resulting in a water resistant cast on application.
It had been previously thought that on applying a water resistant film to the bandage, that this would prevent or inhibit the bandage from being wetted out in order to cure the Plaster of Paris and thus it would be unable to apply the bandage to a patient.
It was also believed that using a fluid vehicle that contained water to apply the water resistant layer would cause premature curing of the cast. The present invention has surprisingly found that using a fluid vehicle that does contain water may not cause significant premature curing of the bandage when applied according to the present invention.
According to the present invention there is provided a Plaster of Paris splint bandage comprising a flexible substrate carrying the hemi-hydrate form of calcium sulphate characterised by that the bandage has a layer of water resistant material which allows the bandage to be cured but when the bandage is set provides water resistance.
The materials referred to as water resistant materials, or as water resistant agents, are defined as materials which when on the Plaster of Paris splint bandage will allow water to penetrate the water resistant material in order to cure the bandage but when the bandage is set will offer some degree of water resistance to the cured bandage.
Also according to the present invention there is provided a Plaster of Paris splint bandage comprising a flexible substrate carrying Plaster of Paris with an upper face and a lower face, wherein at least one of the upper face or the lower face comprises a layer of water resistant material.
The upper face is defined as the side facing away from the limb after application and the lower face is defined as the body facing side of the bandage.
Preferably the water resistant material is applied after the substrate is impregnated with Plaster of Paris. Further for ease of manufacture and use, it is preferred that the water resistant material is applied after the substrate is impregnated with Plaster of Paris but before curing and application of the bandage.
For further ease of applying the water resistant agent, or material, onto the bandage it is convenient if the water resistant material is a fluid, or is contained in a fluid, to give a fluid vehicle in order to allow convenient application of the water resistant material onto the bandage. Used herein the fluid vehicle is the water resistant material in fluid form or any fluid containing the water resistant material.
The fluid vehicle carrying the water resistant material may be applied to the cured bandage after application to a patient but preferably the fluid vehicle carrying the water resistant material is applied during the manufacturing process.
Most aptly the fluid vehicle is sprayed onto the upper face during the manufacturing process, thus providing a layer of a water resistant material. However any method suitable for the application of the fluid vehicle may be used, for example the bandage could be dipped into the fluid vehicle.
The fluid vehicle carrying the water resistant material may be applied to one surface or face of the bandage, either the upper face or the lower face, or may be applied to both faces of the bandage.
Provided that the fluid vehicle can form a layer of the water resistant material on, or within, the bandage, the water resistant material does not necessarily need to be applied to the outer layer of the bandage. Preferably however, the water resistant layer will be on an outer surface or face of the bandage.
The water resistant material is aptly applied neat, i.e. undiluted especially if a fluid for example silane, or in the form of an emulsion, solution, mixture or suspension. The fluid vehicle may consist wholly or partially of the water resistant material.
Any fluid vehicle, suitable to apply the water resistant material on to one or more of the surfaces of the bandage, could in fact be used. The fluid vehicle may be water based, solvent based or a mixture thereof. This would include suspensions and emulsions.
When the fluid vehicle is an emulsion or solution, the emulsion or solution may be prepared from any material that will form an emulsion or solution and which forms a water resistant film on drying after application of the bandage to a limb.
Typically the water resistant material may be in the form of an emulsion, solution or suspension in water. When a solvent is used suitable ratios of solute to solvent are typically 25% to 75%. Suitable solvents that may be used with the present invention include alcohols, ketones, aromatic hydrocarbons, aliphatic hydrocarbons, esters and ethers.
If the water resistant film is only on one side or face of the bandage the opposite face would comprise exposed Plaster of Paris. This enables the Plaster of Paris to wet out quickly, as well as enabling lamination of the layers and smoothing out of the resulting cast.
If the water resistant film is on both sides it is preferable to have a lower individual layer weight of the water resistant material than that used on a bandage with only one layer of the water resistant material. This is to enable the water to migrate through the film more efficiently and this enables the Plaster of Paris to wet out quickly, as well as enabling lamination of the layers and smoothing out of the resulting cast.
On application a water resistant upper face will preferably make up the outside of the cast, thus resulting in a water resistant cast.
Suitably the water resistant layer comprises 1 to 25% by cast weight. The water resistant layer need not be a thick layer provided it can offer water resistance to the bandage and therefore this layer may be less than 1% of the weight of the cast.
Water resistant bandages according to the present invention could be used for the entire cast or just to provide a layer of the water resistant material on, or within, the cast. Therefore water resistant bandages of the present invention could be used in conjunction with ordinary bandages. It is envisaged that where water resistant bandages of the present invention are used in conjunction with ordinary bandages, the water resistant bandages will be applied as a last layer, or outer layer, of the bandaging material making up the cast in order to give an outer water resistant layer of material to protect the cast as a whole. In this way the ordinary bandages can be used to provide a cast of the required thickness or strength, while the water resistant bandages of the present invention provide water resistance to the cast.
Suitably when the fluid vehicle used contains water it will contain an amount of water less than the sto

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