Orthopaedic splinting system

Abstract

A composite material in the form of a linear structure having a width, a length and a thickness, comprising a composite material with a first component formed by a polymer and a second component formed by a reinforcing material, wherein the first component comprises a thermoplastic polymer selected from the group of biodegradable polymers and mixtures thereof, and the second component comprises a woody material derived from platy or granular wood particles. The composite material being formable at a temperature of about 50 to 70° C. and it can be used as a blank for an orthopedic splint.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of Invention[0002]The present invention relates, in general, to forming a structure on or around a body part of an animal or human being. More specifically, it relates to the field of orthopedic splinting materials, methods and apparatus. Described, herein is also a method of using a novel wood-plastic composite as a splint / cast in immobilization of a fractured body part and a kit thereof.[0003]2. Description of Related Art[0004]In cases of bone fracture a splint may be applied for supporting or immobilizing a body part. Such a splint is usually wrapped with an elastic bandage and the rigid portion does not envelope the limb circumferentially. Traditional splinting techniques use a variety of materials including plaster of Paris (used first time in the Crimean war 1854 in treatment of battle wounds), fiber-glass reinforced polyurethane (DE 26 51 089), alumafoam (U.S. Pat. No. 4,213,452 and U.S. Pat. No. 4,153,051; an aluminium strip padded o...

AI Technical Summary

Benefits of technology

[0029]A further advantage of the present invention is that the splinting system is moldable at temperatures very comfortable to patient and not scorching the skin of the patient. Furthermore, the splinting system, when solidifying, forms a rigid overall structure and does not need any further reinforcement than the natural anatomic shape to build up a reliable immobilization splint for the treatment period.

[0030]The composite material can be easily manufactured to any shape or form during manufacture or before use. However, when the splint is applied it has a three-dimensional configuration conforming to the desired body contours without undesirable wrinkling or tearing. The composite splints / casts can be cut to dimensions close to the assumed size of the treated limb from a larger blank to diminish the amount of waste material. Additionally, the leftover composite pieces as well as the abandoned and used splints / casts are fully biodegradable as their components, wood and polycaprolactone, are fully biodegradable and contain no harmful components to human or to environment.

[0031]The linear or flat composite splints, casts and blanks can be easily packaged and stored in compact piles e.g. in emergency rooms where space is limited. When composite casts are packaged appropriately they can be easily stored for at least one year.

[0032]After opening the cast package, the wood like composite plate can be handled without any protection, e.g. gloves and masks, since the component materials are non-toxic. The composite can then be placed in to a heating device having an adjustable thermostat system or a preprogrammed thermostat tailored to the system. The cast can be heated to operating temperature of around 65° C., preferably in dry condition, in less than 10 minutes. At this temperature, the composite is soft, pliable and can be applied to the desired body part or region. Due to thermal characteristics of wood or woody components, the cast does not feel hot on a skin of operating personnel or a patient. The created form closely matches the anatomical contours of the patient's body parts without undesired wrinkling or tearing.

[0033]Due to unique properties of splinting system, the cast remains applicable for around 5-10 minutes after heating even if the surface temperature of the cast decreases close to body temperature. This unique formability and time slot is due to appropriate crystallinity of polymer matrix and wood or woody components providing thermal insulation of certain degree. During the application time, the cast can be easily cut with conventional scissors and reshape to accurately match an injured body part. The full strength properties of the cast is achieved approximately in 20 minutes after the initial hardening; however the time may be shortened to few minutes when an external cooling system is used. In case the clinical practitioner needs to re-formulate the shape of the splint, it can be re-heated to the operating temperature. In this way, an unlimited working period can achieved, which is a clear advantage over the current chemically curable plastic or chalk (POP) splints. It is also a distinctive property of the novel splinting system that notwithstanding the cast is moldable during its cooling period down to lower surface temperatures, the hardened splint does not yield or become malleable until the original operating temperature thr the splint is again reached.

[0034]The entire treatment system is water-free and during heating, applying and use there are no dust, chemicals or vapors released.

Problems solved by technology

This is mainly due to its many well known disadvantages e.g. long setting and drying times, messy application, low strength and relative heaviness which can be quite considerable, thus limiting movement, especially of a child.

Despite these advantages they are far from being ideal casting material.

They require several layers for weight-bearing casts; they may crack from repetitive use and may leave sharp edges, potentially causing excoriation of the skin.

The polyurethane resin based materials are quite resilient for which reason they do not conform well to the extremity.

Further, glassfiber / polyurethane casting materials contain toxic or harmful components (cyanates and fibre-glass) and have to be applied with protective gloves.

According to the MSDS of some fiber reinforced casting materials, skin contact with material during applying may cause itching, redness, dryness etc).

As a result, the hardening process of polyurethane based splints (U.S. Pat. No. 4,376,438) and of Paris (WO 00 / 35501) cannot be stopped or paused once the reaction has started.

Therefore if there is any delay in setting of the casting application it will lead to drying of the casting material and it has to be replaced with new one.

Whatever the development steps for these casting materials are they still contain toxic and irritating components, such as cyanates and calcium sulphate hemihydrates.

However, they lack good molding properties and sufficient rigidity to be used in splinting of extremities.

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