GB2313312A - Orthopeadic splint board - Google Patents

Orthopeadic splint board Download PDF

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Publication number
GB2313312A
GB2313312A GB9609245A GB9609245A GB2313312A GB 2313312 A GB2313312 A GB 2313312A GB 9609245 A GB9609245 A GB 9609245A GB 9609245 A GB9609245 A GB 9609245A GB 2313312 A GB2313312 A GB 2313312A
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United Kingdom
Prior art keywords
mouldable mass
woven fabric
mass
mouldable
temperature
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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GB9609245A
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GB9609245D0 (en
Inventor
Anthony Thomas Greatorex
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Noxet UK Ltd
Original Assignee
British United Shoe Machinery Ltd
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Filing date
Publication date
Application filed by British United Shoe Machinery Ltd filed Critical British United Shoe Machinery Ltd
Priority to GB9609245A priority Critical patent/GB2313312A/en
Publication of GB9609245D0 publication Critical patent/GB9609245D0/en
Priority to DE1997118089 priority patent/DE19718089A1/en
Publication of GB2313312A publication Critical patent/GB2313312A/en
Withdrawn legal-status Critical Current

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/18Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/04Plaster of Paris bandages; Other stiffening bandages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • A61F5/058Splints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/07Stiffening bandages
    • A61L15/12Stiffening bandages containing macromolecular materials
    • A61L15/125Mixtures of macromolecular compounds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C37/00Component parts, details, accessories or auxiliary operations, not covered by group B29C33/00 or B29C35/00
    • B29C37/0078Measures or configurations for obtaining anchoring effects in the contact areas between layers
    • B29C37/0082Mechanical anchoring
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/06Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
    • B29K2105/08Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts of continuous length, e.g. cords, rovings, mats, fabrics, strands or yarns
    • B29K2105/0854Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts of continuous length, e.g. cords, rovings, mats, fabrics, strands or yarns in the form of a non-woven mat
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/25Solid
    • B29K2105/251Particles, powder or granules
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7532Artificial members, protheses

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Mechanical Engineering (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Description

1 ORTHOPAEDIC SPLINT BOARD The present invention relates to orthopaedic
splint board and more particularly, but not exclusively, to orthopaedic splint board moulded to conform to human body parts.
More recently, as an alternative to conventional plasterof-paris orthopaedic splint and castings, thermoformable polymeric materials have been used. For example, polycapralactone has been used both on its own and in combination with fillers and other polymeric materials.
Typically, these thermoformable polymeric materials are heated to a temperature at which they become suitably flaccid to enable forming about a patient's limb or other body part for immobilisation. Alternatively, the splinting material can be pre-formed under vacuum to approximate the necessary shape, e.g. an elbow set at the approximate desired angle, and then this pre-formed unit can be finally moulded using a hot-air gun as required.
It will be understood that to improve patient comfort with regard to feel and perspiration, a fabric liner is conventionally provided beneath the splint. This liner may take the form a cotton hose or other suitable soft, generally woven web material.
Unfortunately, as the liner is generally separate from the splint, there is great potential for friction irritation and wrinkling of the liner in use. In extreme cases it is possible that such irritation and wrinkling may be so severe as to necessitate removal of the splint for adjustment. Such removal may be detrimental to the speed of treatment and repair.
In view of the above. it will be appreciated that occasionally the lining material may be secured to the splint 1 board using an adhesive. However, with thermoformable polymeric materials the adhesives used may be diminished in their bond strength by the heating process, and consequently wrinkling or lining blistering may occur. Thus, even when the lining is secured to the splint board by adhesive, problems of irritation, etc. may still occur.
It is an objective of the present invention to provide an integrated orthopaedic splint board and lining.
In accordance with the present invention there is provided an orthopaedic splint board including an integrated lining, the board comprising a base layer secured to a nonwoven fabric as the liner, the base layer being a mouldable mass comprising:
a) a relatively low-temperature polyester component which softens at a temperature below 700C and which constitutes between 50% and 75% by weight of the 20 mouldable mass; b) a relatively high-temperature polyester which does not soften with the low temperature polyester component and so acts as an inherent regulator of 25 mouldable mass tackiness, the relatively hightemperature polyester component having a melting point which is in excess of the low-temperature polyester component by between 30C and 1200C and a viscosity in the range of 50-10, 000 Poise at 1500C, 30 the relatively high-temperature polyester component consisting of up to 25% by weight of the mouldable mass; c) mineral filler material having a mean dimension less 35 than 800 Pm and consisting up to 50% by weight of the mouldable mass in order to strengthen said mouldable mass when below its softening temperature; 1 the mouldable mass having a softening temperature in the range 55-700C above which the material becomes sufficiently flaccid to ensure moulding about a body, and below which it is desirably resistant to bending; the non-woven fabric being partially penetrated by said base layer in order to resiliently secure such fabric to said base layer with a substantial proportion of said fabric depth not penetrated and thus acting as a lining for the board, the non- woven fabric having a weight and gauge sufficient to ensure such partial penetration by said base layer into the non-woven fabric when said base layer is elevated to above its melt temperature.
is Preferably, the low-temperature polyester component comprises polyepsiloncapralactone andlor polytetramethylene adipate.
Preferably, the high-temperature polyester component comprises a copolyester such as BOSTIK IT' adhesive.
Preferably, the mineral filler is mica or clay or talc and may have a dimension size of up to 250 Pm or, more preferably, a mean dimension below 50 Pm. The mineral filler may have platelet-type nature.
Preferably, the non-woven fabric may have a weight in excess of 250 g/M2.
Preferably, the base layer penetrates the non-woven fabric to a depth of at least 1 mm.
In accordance with an alternative embodiment of the present invention there is provided a method of making an orthopaedic splint board comprising:
a) Formulating and mixing in their powder or granule or flake form thermoformable polymeric materials into a 4 1 mouldable mass; b) Placing said mouldable mass relatively evenly in a mould and laying a non-woven fabric on top of said mouldable mass; c) Placing a top plate in compressive abutment with the non-woven fabric and thus compressing the non-woven fabric toward the mouldable mass; d) Heating the mouldable mass through the mould such that the mouldable mass is consolidated into a fluid gel to enable partial surface penetration of said mouldable mass in its liquid gel form into the non woven fabric; e) Allowing the mouldable mass and the non-woven fabric to cool in order to provide an integral orthopaedic splint board comprising a consolidated mouldable mass as a base layer and the substantially unpenetrated portion of the non-woven fabric as a lining for said orthopaedic splint board.
An embodiment of the present invention will now be described by way of example only with reference to the accompanying drawing, in which a schematic cross-section of a orthopaedic splint board is illustrated. It will be understood that this illustrated embodiment is for illustrative purposes only.
As indicated above, it is known to provide polymeric thermoformable orthopaedic splint materials. Furthermore. these materials can be made by a range of appropriate methods and techniques. However, at some point if the orthopaedic material is to be anything other than purely of one particular polymeric substance, there must be a compounding stage.
Normally polymeric materials are initially provided 1 either as granules, flakes or powders which can be mixed to the appropriate composition in mixer. In effect. the performance of the polymeric material can be altered and determined by its constituent parts. Thus, relatively cheap filler materials can be used to fill out more expensive polymeric substances whilst retaining, and potentially reinforcing, the properties of that polymeric substance.
In the present invention a combination of relatively low- temperature polyester, i.e. polyepsiloncapralactone or polytetramethylene adipate, are combined with a relatively high-temperature polyester component, i.e. BOSTIK I.TI adhesive or another copolyester component, along with a mineral filler, in order to reduce cost and provide some structural reinforcement within the mouldable mass eventually created. The mouldable mass forms the base layer for the orthopaedic splint board. The mouldable mass is made by combining powders or granules of the respective components in a mixer and thoroughly mixing them together to produce as even a distribution as is necessary and/or possible.
It is known that polyester materials such as polyepsiloncapralactone can be moulded at temperatures acceptable for use with warming ovens or possibly with hot- air guns in order to render such material flaccid for moulding purposes about a patient etc. However, such polyester materials of a high molecular weight are relatively expensive and also by their nature too tacky for easy manipulation when flaccid.
It is desirable that the mouldable material or mass should soften at a modest temperature, i.e. 60-70% and thus avoid the necessity and dangers of higher temperatures for use in relation to a patient's skin. Similarly, if the mouldable material or mass is to be used or moulded by a sportsman in order to create personalised shin pads or other protective padding from pre-formed elements it is necessary that only such modest temperatures are used to avoid scalding and other 1 dangers. Furthermore, as indicated above during moulding it is important that wrinkles are avoided and thus the mass should provide smooth moulding. Finally, it is advantageous if the mass was self- adhesive when hot in order to facilitate s enclosure and other desired constructions.
it is the tackiness and cost of pure polyepsiloncapralactone which makes it an imperfect casting material.
The addition of fillers is well-known and documented (see above). However, provision of too much filler will make the mouldable mass too rigid below its softening temperature and possibly brittle, whilst too little filler material will render the mouldable mass too lacking in rigidity and will not sufficiently mitigate cost and tackiness problems.
In the present invention the splint board consists a mouldable mass of various low-temperature melting polyesters associated with higher-melting polyesters and mineral fillers combined with an integral non-woven fabric as a lining. The low-temperature polyester component gives the softening, i.e. moulding characteristics, whilst the high-temperature polyester component reduces tackiness and the mineral filler enhances stiffness and furthermore reduces tackiness. In addition, it is typical to add a pigment in order to achieve a desired colour to the mouldable mass. It may also be possible to add a thermally dependent pigment to allow indication of material temperature, and so acceptability for moulding and retention of adequate stiffness for orthopaedic function. Furthermore, such a thermal dye could indicate whether the material is too hot for application upon a patient.
The low-temperature polyester component to the mouldable mass is most conveniently a combination of two polymeric materials. In the preferred embodiment this low-temperature polyester component comprises polyepsiloncapralactone, i.e.
1 CAPA 656, in order to constitute 35% by weight of the mouldable mass in combination with polytetramethylene adipate, e.g. BOSTIK HM5584, in proportion of 30% by weight of the mouldable mass. Thus, in this preferred embodiment the low- temperature polyester component comprises 65% by weight of the whole mouldable mass. This low-temperature polyester element has a softening point in the desired modest 60-70C temperature range suitable in use with a warming oven or a hot-air gun in order to soften the mouldable mass.
The high-temperature melting polyester component of the mouldable mass, by implication, does not soften atthe modest 60-70'C range for the lowtemperature polyester component of the mouldable mass and thus, as indicated above, reduces its tackiness. However, there will be an inherent variation in the high- temperature melting polyester element viscosity within the mouldable mass, and thus smooth moulding of the material is not jeopardised by introduction of this tackiness regulator component and the material does not become brittle.
Typically the high melting temperature polyester component of the mouldable mass will have a melting point at least 30120C higher than the low-temperature polyester component. Suitable higher-temperature melting polyester materials are BOSTIK 'T1 adhesive or other copolyester materials such as those produced by EMS-CHEMI under their registered trade mark GRILTEX and having a viscosity in the range 50 to 10,000 Poise at 15CC and a softening temperature at least in the range 901209C. It should be understood that the higher melting temperature polyester component of the mouldable mass does not melt during the mould formation process in use. In the preferred embodiment of the present invention the higher temperature melting polyester is BOSTIK 'T' adhesive in the proportion of 10% by weight of the mouldable mass.
The mineral filler used within the mouldable mass enhances its stiffness below the softening temperature, i.e.
60-700C, and also provides additional reduction in the tackiness of the material due to the lOw-temperature polyester 1 component. In fact, the mineral filler may substantially eliminate the higher temperature melting polyester component, provided desired performance criteria will allow an increase in mouldable mass brittleness. There will obviously be a cost benefit in having a higher mineral filler content within the mouldable mass. Types of material that may be used for the mineral filler are mica, talc or clay. It has been found that a filler size less than 800 Pm is acceptable, but preferably below 250 Pm and most advantageously below 50 Pm provides the best results in the mouldable mass. It will be understood that a potentially consistent feature between the mineral filler types outlined above is a platelet nature, and although this feature of the filler does provide beneficial effects in terms of eventual mouldable mass stiffness, it will be understood that other filler configurations may be used separately or in combination with a platelet configuration. In the preferred embodiment of the present invention, the mineral filler is mica in the proportion of 22. 5% of the mouldable mass by weight.
As indicated above it is normal to include within the mouldable mass a pigment in order to achieve the desired colour. In the preferred embodiment this colour is substantially white and thus titanium dioxide is added in a proportion of 2.5% by weight of the mouldable mass.
The final substantial element of the orthopaedic splint board is a nonwoven fabric of a sufficient gauge and weight to inhibit strike through of the mouldable mass in its fluid, gel-like stage. Thus, the non-woven fabric will have a weight greater than 200 g/m2, and more preferably 500 g/M2.
Preferably, the non-woven fabric is a non-woven felt made from polyester fibres using a suitable needle entanglement procedure to an appropriate weight and gauge.
Preferably, the non-woven fabric will have a weight in excess of 500 g/M2 to stop strike through of the mouldable 9 mass.
To summarise the preferred embodiment of the present invention the components are as follows:
Mouldable Mass:
Low-temperature polyester element - polyepsiloncapralactone (35% by weight), i.e. CAPA 656 and/or polytetramethylene adipate (30% by weight), i.e.
BOSTIK HM5584.
High-temperature melting polyester element - copolyester (10% by weight), i.e. BOSTIK IT' adhesive.
is Mineral filler - mica (22.5% by weight).
Pigment - titanium dioxide (2.5% by weight).
Non-woven Fabric:
Polyester non-woven fabric having a weight in excess.of 500 g/M2, the fibres having a decitex in excess of 1.5.
It will be appreciated that the specific composition of the mouldable mass is dependent upon desired performance and expected operating environment. Thus, it will be understood that the low-temperature polyester component may constitute between 50% and 75% by weight of the mouldable mass, the high- temperature melting polyester component between 0% and 25% by weight of the mouldable mass and the mineral filler up to 50% by weight of the mouldable mass. All these figures both immediately and previously above ignore the inherent weight of the non-woven fabric.
As indicated previously the higher melting temperature polyester component may be almost eliminated within the mouldable mass due to the tackiness regulating effect of the 1 mineral filler which although not as effective as the higher temperature melting polyester component still provides a degree of such regulation and thus at high filler component levels may be adequate for practical purposes. Moreover, it is the effect of the higher temperature component of the mouldable mass having a slight increase in softness as the low temperature component softens, rather than remains rigid as the mineral filler, which ensures that, although there is tackiness regulation/control, there is not undue increase in material brittleness due to increase in inert rigid filler content.
It should be understood that the low-temperature polyester component may in some circumstances be replaced by a polyurethane composition having similar physical and most importantly softening characteristics.
Typically, the mouldable mass will have a mean thickness in excess of 3 mm after thermal consolidation. However, thinner sheets may be provided and adhered if desired as a laminate to the appropriate thickness.
It has been found that a mouldable mass in accordance with the preferred embodiment may have in a bending stiffness up to 70 Newtons/mm for a 3.2 mm thickness ignoring the nonwoven fabric. This compares favourably with existing orthopaedic splinting materials.
In order to produce the mouldable mass it is evidently necessary to thermoplastically compound the various polyester, filler and pigment elements together.
In the present invention the mouldable mass can be activated using sintering or powder deposition processes with appropriate heating to consolidate the mass from its initial powder/granule/flake form to a unitary mass. This step is performed in a mould with the non-woven fabric in compressive abutment.
1 The mouldable mass and non-woven fabric. combined as the splint board, can be readily cut with scissors or shears when softened to its flaccid mouldable nature by a warming oven or through exposure to hot air from a hot-air gun. Thus, the splint board can be shaped by an experienced orthopaedic specialist to approximate that necessary to provide splinting about a patient. Alternatively. the splint board could be preformed for immediate use by the orthopaedic specialist or could be supplied to approximate the necessary reinforcing requirement, i.e. as a soccer shin pad which can if desired be further formed by the player to more closely approximate his shin. It will be understood that the lining. is most conveniently applied to the contact side of the orthopaedic splint board in order to increase comfort for the patient or wearer.
The mouldable mass normally is perforated with punched holes appropriately located in order to facilitate vapour, i.e. sweat transfer, across the material and so enhance wearer comfort.
It will be understood that the present mouldable mass can be substantially biodegradable in that, apart from the pigment titanium oxide in the preferred embodiment, all the other components of the mouldable mass will degrade over time. The pigment is not an essential component. Furthermore, the non-woven fabric may be made of materials that degrade, e.g. cotton. However, it should be understood that this biodegradation should not be too short term as a wearer during orthopaedic splint use will generate sweat, etc., which would accelerate degradation.
In order to be acceptable as an orthopaedic splint material, the mouldable mass in accordance with the present invention typically has a weight in the range 0.75 to 5.00 kg/ m2 and a density in the range 900 to in excess of 1,200 kg/ M3. However. it will be appreciated by a person skilled in the art that variations in the proportions of low- 1 temperature polyester, high-temperature polyester and mineral filler can radically alter both material weight and density. It is a balance between mouldability and stiffness which is most important, whilst material weight remains acceptable for comfort.
It will be understood that mouldable materials which are too tacky will present unsightly finger prints on moulding. Moreover, it is advantageous to ensure the mouldable mass is self-adherent in order that further reinforcing straps or closures may be added to a basic structure as required. The present material allows such adherence through the lowtemperature component of the mouldable mass. A moulded piece of mouldable mass may be locally heated with a hot-air gun and similar mouldable mass straps suitably heated and attached under compression.
The above-described mouldable mass is placed in a flat mould and spread as evenly as possible. The formulated granules or powder or flakes can be simply poured into the mould and raked to a substantially even thickness. on top of the formulated, unactivated mouldable mass is placed a nonwoven fabric. on top of the non- woven fabric is placed a top cover for the mould.
The assembly of mouldable mass in its powder or granulated, unactivated form, along with the non-woven fabric held in abutment, in then heated through the mouldable mass. Thus, the mouldable mass melts and, due to the abutment pressure and other natural expansion and migration forces, the mouldable mass partially penetrates the non-woven fabric. It will be appreciated that the effect of gravity and the limited interstices passages within the non-woven fabric felt limit the extent of and, more particularly, the depth of penetration of the mouldable mass into the non-woven fabric. Typically. the mouldable mass will penetrate the non-woven fabric by up to 1 or 2 mm in order to provide a good, secure bond between the mouldable mass and the non-woven fabric.
1 The compressive abutment pressure upon the combination of mouldable mass and fabric may be above 500K Pascals. The bottom mould surface in contact with the mouldable mass may be heated to a temperature of 140C, whilst the top plate in contact with the fabric may be at a temperature of SCC.
After heating, the mouldable mass and non-woven fabric are allowed to cool. Once cooled, the assembly of mouldable mass and non-woven fabric is removed from the mould. Thus, the mouldable mass creates a base layer of thermoformable polymeric material, whilst the non-woven fabric creates a lining integral with that base layer and thus cannot be detached therefrom. Due to the to adherent nature of the bond between the non-woven fabric and the mouldable mass or base layer. it will be appreciated by those skilled in the art that whilst forming about a human limb or other body part, the nonwoven fabric lining does not become detached from the base layer thermoformable structure which provides the rigidity in order to achieve orthopaedic splint performance.
In the drawing it can be seen that the base layer 1 and the non-woven fabric layer 2 have a transitional zone defined by broken lines between them designated 3, which comprises the non-woven fabric 2 impregnated with the mouldable mass. The extent of such penetration of the mouldable mass, base layer 1, into the non-woven fabric 2 is determined by the extent of fluidity created in thermally consolidating the mouldable mass from its initial granular, powder or flake composition, and the amount of the pressure applied in the direction of the arrowhead over the surface of the non-woven fabric 2. The time period involved in the manufacturing process is also important, i.e. over a period of time the fluid-gel mouldable mass may be drawn by capillary action further into the nonwoven fabric. Typically, the mouldable mass will be heated for five minutes.
Temperatures are defined above for illustrating the necessity of heating to achieve a degree of flaccidity to 1 enable moulding into orthopaedic splints. it will be appreciated that the temperature applied through the mouldable mass must be significantly greater than these temperatures in order to achieve gel fluidity in the mass and thus penetration into the non-woven fabric.
To summarise the process to manufacture the orthopaedic splint board, the following steps are outlined below:
a) The unactivated powder mouldable mass comprising the low-temperature polyester component, the hightemperature copolyester component and filler material are laid in a mould with a layer of nonwoven fabric on top.
is b) The combination of unactivated mouldable mass and non-woven fabric are then compressed by a top plate for the mould. The mould and top plate compress the constituents in the mould.
C) The bottom batten of the mould is heated, i.e. 1400C, whilst the top plate in contact with-the nonwoven fabric is cool, i.e. 5CC. Thus, the mouldable mass is heated to a temperature where it becomes a fluid gel and penetrates the non-woven fabric to a limited extent.
d) The temperature at which the mouldable mass is heated is carefully determined to ensure that the mouldable mass becomes adhered to the non-woven fabric, but is not sufficient to allow absorption of the melted, mouldable mass into the felt to an appreciable degree, i.e. strike through from one surface to the other surface of the non-woven fabric.
In order to stop possible lateral flow of the fluid-gel mouldable mass in the mould, a sacrificial border of non-woven 1 fabric may be added. This border may be removed after cooling.
It will be understood that a wide range of mouldable mass blends and weights could be used dependent upon the desired performance of the eventual orthopaedic splint board.
As only a limited interface surface of the fabric is penetrated by the mouldable mass, i.e. base layer 1, adhered to one side of the fabric, the performance of the non-woven fabric is excellent as a lining for any eventual orthopaedic splint. The loft and fleece-like nature of the non-woven fabric is substantially retained.
The non-woven fabric is generally made using a mechanical or needle entanglement procedure. Examples of such non-woven fabric manufacturing procedures are given below for completeness.
Example 1
A batt made up of one or more layers was produced from a fibre blend of 80% 1.7 decitex 51 mm polyester fibres and 20% 5.0 decitex 40 mm staple polyester fibres.
The felt was then needles in a three-stage operation. In the tacking stage, the batt was passed between up-and-down stoking needle boards fitted with 15 x 18 x 40 x 3 F222 G92919 needles marketed by Groz Beckaert. The penetration of both the top and bottom needles was 14 mm in the first needling stage, the batt was passed under a single needle board fitted with a mixture of 67% 15 x 18 x 40 x 3.5 R333 G1909 needles and 33% Foster 15 x 18 x 40 x 3.5 CB F20 9-18-3B needles. Needling was carried out using a downstroke only, with a penetration of 6.1 mm at a needle punch density of 93.
In the second needling stage, the partially needled batt was passed between up-and-down stroking needle boards, fitted 1 with a mixture of 67% 15 x 18 x 40 x 3.5 R333 G1909 needles and 33% foster 15 x 18 x 40 x 3.5 CB F20 9-18-3B needles. The top penetration was 4.6 wm and the bottom penetration 5.6 mm with a needle punch density of 329 and head speed of 509 rpm.
Example 2
A batt was produced from a fibre blend of 80% 1.7 decitex 51 mm polyester fibres and 20% 5.0 decitex 40 mm staple polyester fibres.
The felt was then needles in a three-stage operation. In the tacking stage, the batt was passed between up-and-down stroking needle boards, fitted with 15 x 18 x 40 x 3 F222 G92919 needles marketed by Groz Beckaert. The penetration of both the top and bottom needles was 14 mm in the first needling stage, the batt was passed under a single needle board fitted with a mixture of 67% 15 x 18 x 40 x 3.5 R333 G1909 needles and 33% Foster 15 x 18 x 40 x 3.5 CB F20 9-18- 3B needles. Needling was carried out using a downstroke only, with a penetration of 6.1 mm at a needle punch density of 83.
In the second needling stage, the partially needled batt was passed between up-and-down stroking needle boards, fitted with a mixture of 67% R333 15 x 18 x 40 x 3.5 G1909 needles and 33% Foster 15 x 18 x 40 x 3.5 CB F20 9-18-3B needles. The top penetration was 0.2 mm and the bottom penetration 5.6 mm with a needle punch density of 392 and head speed of 605 rpm.
Example 3
A batt was produced from a fibre blend of 80% 1.7 decitex 51 mm polyester fibres and 20% 5.0 decitex 40 mm staple polyester fibres.
The felt was then needles in a three-stage operation. In the tacking stage, the batt was passed between up-and-down stroking needle boards, fitted with 15 x 18 x 40 x 3 F222 1 G92919 needles marketed by Groz Beckaert. The penetration of both the top and bottom needles was 14 mm in the first needling stage, the batt was passed under a single needle boardfitted with a mixture of 67% 15 x 18 x 40 x 3.5 R333 G1909 needles and 33% Foster 15 x 18 x 40 x 3.5 CB F20 9-18-3B needles. Needling was carried out using a downstroke only, with a penetration of 6. 1 mm at a needle punch density of 86.
In the second needling stage, the partially needled batt was passed between up-and-down stroking needle boards, fitted with a mixture of 67% R333 15 x 18 x 40 x 3.5 G1909 RB needles and 33% Foster 15 x 18 x 40 x 3.5 CB F20 9-18-3B needles. The top penetration was 4.7 mm and the bottom penetration 5.6 mm, with a needle punch density of 337 and head speed of 501 rpm.
is A preferred weight for a fabric in the present invention is about 0.500 kg/m2 and a nominal gauge of 4.0 mm.
It will be understood that the present orthopaedic splint material can be manufactured in an appropriate mould for specific requirements. Thus, small batches of mouldable mass in the form of powder, granules or flakes can be mixed-to provide specific performance and a non-woven felt chosen to achieve necessary lining performance. Thus, individual orthopaedic splint board can be made to a particular patient's requirements.

Claims (7)

1 Claims:
1. An orthopaedic splint board including an integral lining, the board comprising a base layer secured to a non- woven fabric as the lining, the base layer being a mouldable mass formulated from and comprising:
a) A relatively low-temperature polyester component which softens at a temperature below 70C and which constitutes between 50% and 75% by weight of the mouldable mass; b) A relatively high-temperature polyester component which does not soften with the low-temperature polyester component and so acts as an inherent regulator of mouldable mass tackiness, the relatively high-temperature polyester component having a melting temperature which is in excess of the low-temperature polyester component by between 30C and 120C and a viscosity in the range 50 10f000 Poise at 1500C, the relatively high temperature polyester component consisting up to 25% by weight of the mouldable mass; C) Mineral filler material having a mean dimension less than 800 Pm and constituting up to 50% by weight of the mouldable mass in order to strengthen said mouldable mass when below its softening temperature; the mouldable mass as a whole having a softening temperature in the range 55-700C above which the mass becomes sufficiently flaccid to enable moulding about a body and below which it is desirably resistant to bending, the non-woven fabric being adhered to said base layer in order to resiliently secure such fabric to said base layer, such bond between said base layer and said non-woven fabric being achieved by melting said mouldable mass and presenting said 1 non-woven fabric in compressive abutment with that molten mouldable mass.
2. An orthopaedic splint board as claimed in Claim 1 wherein the low-temperature polyester component comprises polyepsiloncapralactone and/or polytetramethylene adipate having a desired softening temperature.
3. An orthopaedic splint board as claimed in Claim 1 or Claim 2 wherein the high-temperature polyester component comprises a copolyester such as BOSTIK 'TI adhesive having the necessary physical characteristics to achieve. material tackiness regulation for ease of handling.
4. An orthopaedic splint board as claimed in Claim 1, 2 or 3 wherein the mineral filler is mica and/or clayandlor talc.
5. An orthopaedic splint material as claimed in any preceding Claim wherein the non-woven fabric has a weight in excess of 200 g/m2 in order to ensure the mouldable mass does not strike through or completely impregnate the non-woven fabric.
6. A method of making an orthopaedic splint board comprising:
a) Formulating and mixing in their powder or granule or flake form thermoformable polymeric materials into a mouldable mass; b) Placing said mouldable mass relatively evenly in a mould and laying a non-woven fabric on top of said mouldable mass; c) Placing a top plate in compressive abutment with the non-woven fabric and thus compressing the non-woven fabric toward the mouldable mass; 1 d) Heating the mouldable mass through the mould such that the mouldable mass is consolidated into a fluid gel to enable partial surface penetration of said mouldable mass in its liquid gel form into the non woven fabric; e) Allowing the mouldable mass and the non-woven fabric to cool in order to provide an integral orthopaedic splint board comprising a consolidated mouldable mass as a base layer and the substantially unpenetrated portion of the non-woven fabric as a lining for said orthopaedic splint board.
7. A method as claimed in Claim 6 wherein in order to facilitate containment of the mouldable mass in its fluid-gel state a further step of placing a sacrificial border about said periphery of the mould is provided to limit lateral flow of said fluid mouldable mass, said sacrificial border being cut from the splint board after cooling.
GB9609245A 1996-05-02 1996-05-02 Orthopeadic splint board Withdrawn GB2313312A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB9609245A GB2313312A (en) 1996-05-02 1996-05-02 Orthopeadic splint board
DE1997118089 DE19718089A1 (en) 1996-05-02 1997-04-29 Orthopedic splint

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB9609245A GB2313312A (en) 1996-05-02 1996-05-02 Orthopeadic splint board

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GB2313312A true GB2313312A (en) 1997-11-26

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1029521A2 (en) * 1999-02-19 2000-08-23 Karl Otto Braun KG Thermoplastic bandaging material and its manufacturing process
WO2011070135A1 (en) * 2009-12-11 2011-06-16 Rhodia Operations Composite polyester article
CN102764174A (en) * 2012-07-13 2012-11-07 苏州艾美医疗用品有限公司 Medical polymer non-woven fabric splint and preparation method thereof

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1366091A (en) * 1970-07-20 1974-09-11 Union Carbide Corp Formable orthopedic cast materials resultant casts and method
US4169469A (en) * 1975-07-29 1979-10-02 Yardney Company Orthopedic device
US4600618A (en) * 1984-03-16 1986-07-15 Raychok Jr Paul G Splint material with hook and loop fastener
EP0263552A2 (en) * 1986-10-08 1988-04-13 Tom Paul Marthe Ghislain Ponnet Composite material for medical or paramedical, particularly orthopaedic use and method for manufacturing it
WO1994003211A1 (en) * 1992-08-07 1994-02-17 British United Shoe Machinery Limited Orthopaedic splinting/casting material

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1366091A (en) * 1970-07-20 1974-09-11 Union Carbide Corp Formable orthopedic cast materials resultant casts and method
US4169469A (en) * 1975-07-29 1979-10-02 Yardney Company Orthopedic device
US4600618A (en) * 1984-03-16 1986-07-15 Raychok Jr Paul G Splint material with hook and loop fastener
EP0263552A2 (en) * 1986-10-08 1988-04-13 Tom Paul Marthe Ghislain Ponnet Composite material for medical or paramedical, particularly orthopaedic use and method for manufacturing it
WO1994003211A1 (en) * 1992-08-07 1994-02-17 British United Shoe Machinery Limited Orthopaedic splinting/casting material

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1029521A2 (en) * 1999-02-19 2000-08-23 Karl Otto Braun KG Thermoplastic bandaging material and its manufacturing process
EP1029521A3 (en) * 1999-02-19 2004-07-28 Karl Otto Braun KG Thermoplastic bandaging material and its manufacturing process
WO2011070135A1 (en) * 2009-12-11 2011-06-16 Rhodia Operations Composite polyester article
FR2953846A1 (en) * 2009-12-11 2011-06-17 Rhodia Operations COMPOSITE POLYESTER ARTICLE
CN102656005A (en) * 2009-12-11 2012-09-05 罗地亚经营管理公司 Composite polyester article
CN102656005B (en) * 2009-12-11 2015-03-25 罗地亚经营管理公司 Composite polyester article
US9283694B2 (en) 2009-12-11 2016-03-15 Rhodia Operations Composite polyester article
CN102764174A (en) * 2012-07-13 2012-11-07 苏州艾美医疗用品有限公司 Medical polymer non-woven fabric splint and preparation method thereof

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DE19718089A1 (en) 1997-11-27
GB9609245D0 (en) 1996-07-03

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