EP0653944A1 - Orthopaedic splinting/casting material - Google Patents
Orthopaedic splinting/casting materialInfo
- Publication number
- EP0653944A1 EP0653944A1 EP94906749A EP94906749A EP0653944A1 EP 0653944 A1 EP0653944 A1 EP 0653944A1 EP 94906749 A EP94906749 A EP 94906749A EP 94906749 A EP94906749 A EP 94906749A EP 0653944 A1 EP0653944 A1 EP 0653944A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- polyester
- filler
- weight
- range
- set out
- 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.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/07—Stiffening bandages
Definitions
- This invention is concerned with orthopaedic splinting/casting materials.
- GB-A-1 366 091 various formable orthopaedic cast materials in the form of a bandage, web, film, tape or sheet for use in the treatment of both human and animal bodies, in particular in the case of broken limbs and sprains.
- high molecular weight poly-epsilon- caprolactone either as a component of a blend or as a sole polymeric constituent.
- Poly-epsilon-caprolactone had the advantage of being easily and rapidly applicable to the affected body part when heated to a moulding temperature, while forming a rigid, non-irritating, strong, durable, water-resistant, close-fitting splint or cast when at temperatures below the softening temperature, which splint or cast was nevertheless easily removable when no longer required without risk of injury or irritation to the patient and indeed without serious damage to the material itself, which could therefore be sterilised and re-used, if desired. Because the splint or cast could be custom-made from sheet or the like, furthermore, it was not necessary to stock different sizes or styles of splint or cast.
- splints or casts made from poly-epsilon-caprolactone are relatively light in weight and do not have the disadvantages of being bulky, as was the case with previously used plaster of Paris, for example.
- the softening temperature of poly-epsilon-caprolactone is in the range 55 to 70°C, which, especially bearing in mind the low thermal conductivity of the material, would not cause discomfort to the patient whose body part is brought into contact with the thus softened material.
- fillers which also of course in general render the cost of the material cheaper.
- the proposed fillers in this case include magnesium or calcium carbonate, finely divided silica, clay, asbestos and alpha cellulose, the filler particles in each case being in a size range of 3 to 4 microns.
- fillers having a particle size up to 50 microns have been proposed, again however of the same filler types as referred to in GB-A-1 366 091.
- a material for use in reinforcing/stiffening shoes which material comprises a polyester having a molecular weight of not less than 10,000 and a viscosity measured at 100°C of at least 30 Pa.s in combination with a filler, said material being mouldable at a temperature in the range 55 to 70 ⁇ C, having a weight in the range 0.75 to 1.25 kg/m-2, a density in the range 900 to 1200 kg/m-3, and a modulus, at ambient temperature, in the order of 350 to 700 mPa.
- EP-A-0 448 294 which material comprises a polyhexamethylene adipate of the type described, along with its manner of manufacture, in EP-A-0 448 079.
- EP-A-0 349 140 and EP-A-0 183 912 respectively shoe reinforcing/stiffening materials comprising a polycaprolactone.
- a filler which is made wholly of or at least a surface of which is coated with a synthetic material, one preferred embodiment comprising hard PVC.
- a filler is proposed in the form of pulverised fuel ash, while in EP-A-0 448 294, in addition to the two fillers already referred to, a proposal is made to utilise almond shell grain, olive stone grain or wood flour.
- the grain size distribution in each of the three EP Specifications referred to is substantially greater, being in the order of 50 to 500, preferably 100 to 400 (in the case of 0 183 912), 350 microns (in the case of 0 349 140), and up to 600 microns (in the case of 0 448 294).
- a substantially higher grain size distribution of the filler is encountered than in the previous cases relating to splinting/casting materials.
- a splinting or casting material based upon poly-epsilon-caprolactone, or indeed any other splinting or casting material
- it is highly desirable that the "feel" of the contacting surface of the material is comfortable to the patient.
- a suitable sheet material can be interposed between the casting or splinting material on the one hand and the skin on the other, but, in particular in the case of smaller body parts, such an interlining would be detrimental to the accuracy of the moulding to the shape of the body part in question.
- the shoe reinforcing/stiffening materials are in certain circumstances, and with selected fillers, appropriate in resolving the object of the present invention. More particularly, the solution in accordance with the present invention resides in the use, as an orthopaedic splinting or casting material, of a material in sheet or strip form comprising not less than 50% by weight of a polyester having a molecular weight of not less than 10,000 and a viscosity measured at 100°C of at least 30 Pa.s, and up to 50% by weight of a cellulosic filler, said material being mouldable at a temperature in the range 55 to 70°C, being self-adherent at such moulding temperature, and having a weight in the range 0.75 to 4.0 kg/m 2 , a density in the range 900 to 1200 kg/m 3 , and a modulus, at ambient temperature, of not less than
- the stiffness of the material which is of course a function of the thickness and modulus, depends largely upon the requirements for the particular body part to be treated. Thus, in the case of, say, a fractured limb, a heavy gauge material will be required in order totally to immobilise the limb in question. In the case of a moderate sprain, on the other hand, a much less thick (and thus a much less stiff) material will be adequate. It is likely, therefore, that materials having a thickness in the range 1 to 4mm will be adequate for most purposes in accordance with the invention.
- Suitable polyesters for use in a material as referred to above are preferably aliphatic polyesters, e.g. poly-epsilon-caprolactone (which is a polymer formed of a cyclic ester) and polyhexamethylene adipate of a type having high molecular weight, as disclosed in EP-A-0 448 079.
- the polyester has a molecular weight of at least 30,000 and a viscosity measured at 100°C of at least 600 Pa.s.
- the material comprises not less than
- polyester:filler ratio is in the order of 60:40.
- the material incorporates a fabric layer at or adjacent at least one surface.
- the fabric layer is preferably a non-woven synthetic material, e.g. viscose or polyester, having a melt temperature higher than that of the polyester, in which case there is little or no tendency for the non-woven layer to soften when the polyester/filler composition is softened.
- the or each fabric layer has a weight not exceeding about 0.025 kg/m 2 .
- the effect of the layer(s) is to render the hot material more readily capable of being handled comfortably not only from the point of view of the heat in the composition, but also in reducing the tendency of the material to stick to the hands of the person handling it.
- the fabric layer has the same effect in relation to the skin of the patient.
- an air gap is created between the material and the skin of the patient, and this air gap is believed to contribute to the comfortable "feel" of the material when in use.
- a further advantage of the use of a fabric layer in this manner is that it can be utilised to alter the tensile properties of the finished product; where, for example a non-woven layer is used which has been produced by carding and then bonding fibres, it significantly restrains elongation of the finished product in the "machine" direction, i.e. the direction in which the fibres are laid.
- machine direction i.e. the direction in which the fibres are laid.
- the tendency of the composition to stretch when softened can be restrained in all directions.
- the cellulosic filler is preferably selected from one or a combination of the following: ground almond shell having a grain size distribution of 150 to 400 microns, ground olive stones having a grain size distribution of 150 to 400 microns, and wood flour having a grain size distribution of up to a maximum of 600 microns. It will of course be appreciated by the selection of different fillers, the stiffness of the finished product can be varied. The selection of a particular cellulosic filler to be used will be determined largely according to the desired weight and stiffness of the finished product.
- One significant advantage of the material referred to above has been found to be that it is substantially transparent to X-rays. Thus it is possible, while a splint made of said material remains in situ for the limb to be X-rayed without any significant increase in the level of radiation.
- a preferred manner of manufacturing the material for use as referred to above is by a powder deposition process in which the polyester in powder form is first mixed with the filler; it should of course be understood that the grain size distribution of the polyester powder should be the same as or closely similar to that of the filler in order to ensure proper mixing and to prevent separating out during dispensing of the powder.
- the thus mixed powder is then deposited in a measured layer on a band of non-woven fabric which passes beneath the dispensing hopper and is supported on a suitable belt and thereafter preferably a second layer of non-woven fabric is laid over the thus deposited layer and the "sandwich" is passed through a double-band press, e.g. of the type described in EP-A-0 322 145.
- This press serves by heating and subsequent cooling to fuse and consolidate the powder into a continuous material; if desired, a pre-heating step may be included prior to the second non-woven layer being introduced, this pre-heating step serving to cause an initial fusion of the powder materials.
- a pre-heating step may be included prior to the second non-woven layer being introduced, this pre-heating step serving to cause an initial fusion of the powder materials.
- the press may be replaced by an oven, in which case the second non-woven layer may be dispensed with, while in yet another method of production two plies of material are used, one comprising two layers of a non-woven fabric with a polyester layer therebetween, as referred to above, and the other comprising a layer of polyester having a layer of non-woven fabric on one side only thereof, the two dies being placed in face-to-face contact, with the labric surface of the second ply exposed, and being passed through a double-band press as aforesaid.
- one layer of non-woven fabric is thus located between the two polyester layers.
- the material In using the material, firstly it is necessary to soften it by the application of heat. In one preferred use this is effected by immersing the material in a bath of hot water at, say, 70 ⁇ C; alternatively, if available an oven may be used for the same purpose. Where the material is in sheet form it will normally have been cut to an appropriate size and shape prior to immersion or other form of heating, while if in the form of a strip, e.g. a bandage, it will have been cut to length prior to immersion or other heating. When the material has reached the desired temperature it is then removed from the heat source and applied to the body part of the patient.
- the substance of the material has been heated to a relatively high temperature, in terms of what is tolerable by the patient, because of the relatively low thermal conductivity of the material, it is unlikely that significant discomfort will be caused to the patient by bringing the material into skin contact.
- the material will remain mouldable for a known period, likely to be between one minute and, say, five minutes, thus giving a "window" for the moulding of the material to the affected body part of the patient.
- the material will be self-adherent for at least the initial part of the "window", so that it is possible for the person treating the patient to mould the material to the desired shape and to cause it to adhere to itself, as least as a temporary fixing.
- the fixing by self-adherence may be adequate; in the case of casts for fractured limbs, on the other hand, it may be desirable to provide further straps, which may be of the same material, applied subsequently, e.g. by heating locally with a heat gun.
- this may be achieved by again heating to soften the material and then to unwrap it.
- the mixture was then fed to a hopper through which it was dispensed at a uniform rate onto a lightweight non-woven polyester fabric having weight of 0.18 kg/m 2 supported by the lower belt of a double-band press by which the fabric was advanced beneath the hopper at a uniform rate.
- the material was then passed between two consolidating rollers having also a surface temperature maintained at or about 5°C.
- the material could thereafter either be stored in roll form (the material still being sufficiently mouldable for this purpose) or be cut into sheets and stacked.
- Modulus (at ambient temperature) 373 MPa This material was capable of being used either in strip form, e.g. as a bandage, or in sheet form. Because of its relatively low gauge, it is unlikely that such material in sheet form would be used other than for splinting or perhaps for casting in the case of relatively small body parts.
- Example II The same polyhexamethylene adipate and filler as used in Example I was also used in this Example in the same ratio, but in this case the characteristics of the finished material were as follows:
- the material was made in a laboratory using a conventional platen press with shims between the platens to determine the thickness to which the material was consolidated.
- the material in this case was a powder mixture in the following ratio by weight:
- Ground almond Shell having a particle size of 300-600 microns 20
- Wood Flour have a particle size of 0-400 microns 20
- the above mixture was dispersed on release paper and, after dispersion, a further release paper was placed over the mixture and the "sandwich" was placed in the platen press and consolidated at a temperature of 120 ⁇ C.
- the finished product had the following physical features:
- Thickness 1.43mm Weight 1.6 kg/m 2
- each ply comprises a layer of a polyhexamethylene adipate in powder form having a molecular weight, viscosity and particle size in a similar range to that of the polyhexamethylene adipate of Example I, but in this case being identified by the designation Bostik HM5512AE.
- the polyester was mixed with a cellulosic filler in the form of ground almond shell having a particle size range of 150 to 400 microns.
- the first ply of said material was produced by depositing a metered polyester:filler layer on a layer of non-woven polyester fabric and thereafter a further layer of the same fabric was placed thereover.
- the second ply was produced by depositing a metered layer of the polyester:filler mixture on a layer of polyester non- woven fabric. The two plies were then superposed with the fabric surface of the second ply exposed; that is to say with one of the fabric layers of the first ply intermediate the two polyester layers. The “sandwich” was then passed through a double-band press and the process was completed generally in the same manner as described in Example I.
- the finished material had the following characteristics:
- the moisture vapour permeability was 385mg/m 2 /hr.
- the material exhibited good handling qualities and has been found suitable for use as a casting material.
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Materials Engineering (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Eye Examination Apparatus (AREA)
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9216775 | 1992-08-07 | ||
GB929216775A GB9216775D0 (en) | 1992-08-07 | 1992-08-07 | Orthopaedic splinting/casting material |
PCT/GB1993/001670 WO1994003211A1 (en) | 1992-08-07 | 1993-08-06 | Orthopaedic splinting/casting material |
Publications (1)
Publication Number | Publication Date |
---|---|
EP0653944A1 true EP0653944A1 (en) | 1995-05-24 |
Family
ID=10719977
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP94906749A Ceased EP0653944A1 (en) | 1992-08-07 | 1993-08-06 | Orthopaedic splinting/casting material |
Country Status (6)
Country | Link |
---|---|
EP (1) | EP0653944A1 (en) |
JP (1) | JPH08500748A (en) |
AU (1) | AU4722593A (en) |
CA (1) | CA2141686A1 (en) |
GB (1) | GB9216775D0 (en) |
WO (1) | WO1994003211A1 (en) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NL9101082A (en) * | 1991-06-24 | 1993-01-18 | Tom Paul Marthe Ghislain Ponne | THERMOPLASTIC MATERIAL FOR ORTHOPEDIC AND SURGICAL APPLICATIONS. |
EP0693914B1 (en) * | 1993-04-16 | 1998-12-23 | Minnesota Mining And Manufacturing Company | Orthopedic casting materials |
US6027465A (en) * | 1993-04-16 | 2000-02-22 | Minnesota Mining And Manufacturing Company | Method of immobilizing a body member using a composite article |
JPH08508911A (en) * | 1993-04-16 | 1996-09-24 | ミネソタ マイニング アンド マニュファクチャリング カンパニー | Orthopedic casting material |
EP0857473B1 (en) * | 1994-01-21 | 2003-03-26 | Minnesota Mining And Manufacturing Company | Orthopedic casting material |
FR2733185B1 (en) * | 1995-04-21 | 1997-06-06 | Rosier Pascal | PROCESS FOR PRODUCING OBJECTS, PARTICULARLY WITH REMODELABLE EXTERNAL SURFACE |
GB2313312A (en) * | 1996-05-02 | 1997-11-26 | British United Shoe Machinery | Orthopeadic splint board |
DE19964422B4 (en) * | 1998-06-26 | 2008-01-24 | Bsn Medical Gmbh & Co. Kg | Orthopedic bandage to stabilize limbs and their extremities |
DE19907043B4 (en) | 1999-02-19 | 2005-03-24 | Karl Otto Braun Kg | Thermoplastic bandage material and method for its production |
DE10316617A1 (en) * | 2003-04-11 | 2004-11-11 | Bk Giulini Chemie Gmbh & Co. Ohg | Thermoplastic stiffening material for use in shoe production comprises a hot-melt adhesive, e.g. a mixture of linear polyester and ethylene-vinyl acetate copolymer, and a filler, e.g. wood flour |
ES2261082B1 (en) * | 2005-04-19 | 2007-12-16 | Universidad Politecnica De Valencia | PROCEDURE OF MANUFACTURE OF A WOOD ALTERNATIVE MATERIAL AND MATERIAL AS OBTAINED. |
FI125448B (en) * | 2009-03-11 | 2015-10-15 | Onbone Oy | New materials |
FI123137B (en) | 2010-09-11 | 2012-11-30 | Onbone Oy | Casting Materials |
FI20136038L (en) | 2013-10-21 | 2015-04-22 | Onbone Oy | New materials |
FI126725B (en) | 2013-10-21 | 2017-04-28 | Onbone Oy | Aerated materials |
BR102017019022A2 (en) * | 2017-09-05 | 2019-03-26 | Prx Importadora E Exportadora Ltda | THERMOPLASTIC MATERIAL FOR VETERINARY USE? |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA1070201A (en) * | 1975-11-19 | 1980-01-22 | Kenneth M. Holland | Moldable plastic orthopedic cast |
US4404333A (en) * | 1981-11-06 | 1983-09-13 | Daicel Chemical Industries, Inc. | Thermoplastic polyester resin, production of same, and orthopedic cast material produced therefrom |
US4717496A (en) * | 1984-12-03 | 1988-01-05 | Giulini Chemie Gmbh | Stiffening material with melt-adhesive properties |
DE3729262A1 (en) * | 1987-09-02 | 1989-03-23 | Bayer Ag | THERMOPLASTIC CONSTRUCTION MATERIAL |
GB2242197A (en) * | 1990-03-23 | 1991-09-25 | Bostik Ltd | High-molecular weight polyhexamethylene adipate |
-
1992
- 1992-08-07 GB GB929216775A patent/GB9216775D0/en active Pending
-
1993
- 1993-08-06 EP EP94906749A patent/EP0653944A1/en not_active Ceased
- 1993-08-06 AU AU47225/93A patent/AU4722593A/en not_active Abandoned
- 1993-08-06 JP JP6505143A patent/JPH08500748A/en active Pending
- 1993-08-06 CA CA 2141686 patent/CA2141686A1/en not_active Abandoned
- 1993-08-06 WO PCT/GB1993/001670 patent/WO1994003211A1/en not_active Application Discontinuation
Non-Patent Citations (1)
Title |
---|
See references of WO9403211A1 * |
Also Published As
Publication number | Publication date |
---|---|
GB9216775D0 (en) | 1992-09-23 |
CA2141686A1 (en) | 1994-02-17 |
WO1994003211A1 (en) | 1994-02-17 |
AU4722593A (en) | 1994-03-03 |
JPH08500748A (en) | 1996-01-30 |
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Legal Events
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PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
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17P | Request for examination filed |
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