WO2017103621A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2017103621A1
WO2017103621A1 PCT/GB2016/053979 GB2016053979W WO2017103621A1 WO 2017103621 A1 WO2017103621 A1 WO 2017103621A1 GB 2016053979 W GB2016053979 W GB 2016053979W WO 2017103621 A1 WO2017103621 A1 WO 2017103621A1
Authority
WO
WIPO (PCT)
Prior art keywords
tool
polymeric material
vacuum
layer
medical device
Prior art date
Application number
PCT/GB2016/053979
Other languages
English (en)
Inventor
Tim COONEY
Original Assignee
Orthotic Composites Limited
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Orthotic Composites Limited filed Critical Orthotic Composites Limited
Priority to EP16815920.0A priority Critical patent/EP3389973A1/fr
Publication of WO2017103621A1 publication Critical patent/WO2017103621A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/22—Making multilayered or multicoloured articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • 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
    • 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
    • A61L15/12—Stiffening bandages containing macromolecular materials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/12—Spreading-out the material on a substrate, e.g. on the surface of a liquid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/20—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. moulding inserts or for coating articles

Definitions

  • the present invention relates to medical devices, in particular orthotic or prosthetic devices. More specifically, the present invention relates to a method of making an orthotic or prosthetic composite, and an apparatus for carrying this method.
  • Plaster of Paris is widely used in orthotic and prosthetic manufacturing to both capture the shape of a person's anatomy, and to modify a workable and unique 'tool' (or positive mould) for use in creating the resultant orthosis or prosthesis.
  • Technicians first create a 'tool' which is a positive shape that reflects an accurate three dimensional configuration of the person's body part to result in robust orthesis/prosthesis manufacture.
  • the advantage of using Plaster of Paris when creating the 'tool' is that it is safe, adaptable and cheap.
  • Plaster of Paris is a suitable material to use when vacuum-forming composites and plastics, or bending metals, during the subsequent manufacture of the orthotic/prosthetic device.
  • a known method of manufacturing an orthotic or prosthetic using composite material is known as "infusion composite” manufacturing.
  • the method comprises wetting a thin polyvinyl acetate (PVA) bag, and then pulling it over the positive Plaster of Paris 'tool'.
  • PVA polyvinyl acetate
  • the bag shrinks on drying thereby surrounding the plaster, forming a seal and providing a new surface to work on.
  • the tightly fitting PVA bag is tightened further over the 'tool' using active vacuum suction.
  • An alternative prior art method of manufacturing an orthotic or prosthetic composite comprises using pre-impregnated (i.e. "pre-preg") composite fibres, i.e. composite fibres which are already impregnated with a resin.
  • pre-preg pre-impregnated composite fibres
  • the method involves first placing a wetted PVA bag over the surface of a positive plaster cast or 'tool'. The bag is allowed to dry and then tightened further using active vacuum suction. Pre-preg fibres are then placed on the bag-covered tool, and another bag is then placed over the fibres and put under vacuum. Heat is then used to cure the resin which is already present in the system. This process allows control of the resin content of the product.
  • a problem with this method is that it does not overcome the problems of the PVA bag being fragile and having to remain under vacuum for the entire time that the technician overlays the fibres on to tool, and prepares the tool for the oven cure step. Additionally, the PVA bag is usually destroyed during the heat curing step. This means that the entire process must be repeated if a further curing step is required.
  • a method of making a medical device comprising:- contacting a portion of a tool corresponding to a subject's body part with a layer of polymeric material configured to retain the shape of the tool in the absence of a vacuum;
  • the method of the first aspect does not require the use of PVA bags, because the polymeric material retains the shape of the tool in the absence of a vacuum.
  • the curing step does not damage the layer of polymeric material, and so the tool can be used in multiple cure cycles without adjustment to the tool or the protective polymeric layer being necessary.
  • the medical device may comprise a portion of the polymeric material.
  • the tool corresponding to a subject's body comprises a unique tool manufactured for a subject.
  • the method comprises a step of manufacturing the tool in a process generally known as "rectification".
  • the tool may comprise any material capable of withstanding pressure of between ⁇ and 3 bar and 120°C heat without changing shape.
  • the tool comprises plaster.
  • the plaster comprises Plaster of Paris.
  • the tool may be
  • a plaster bandage is preferably used to produce a negative plaster mould of the intended subject's body part or limb.
  • the negative plaster mould is then filled with liquid plaster whilst a vacuum tube (which is preferably, a metal tube) is placed in the space as it is filled.
  • a vacuum tube which is preferably, a metal tube
  • the liquid plaster is allowed to dry, and the original plaster bandage is removed, thereby creating a positive mould, which is an accurate representation of the subject's body part or limb.
  • a technician preferably applies and removes plaster from the positive mould.
  • the aim of the plaster 'rectification' is to obtain a suitable shape for the medical device, which is preferably a prosthesis or orthosis.
  • a technician should be mindful of bony
  • material is preferably added in these areas to alleviate pressure in the final medical device that is made. Conversely, material is preferably removed from areas of the body that are more tolerant to pressure in order to obtain an intimate fit.
  • a polyurethane milled tool is manufactured for use in the method of the first aspect.
  • a digital scan of the subject's body part or limb is taken with scanning equipment.
  • the shape is 'rectified' using software with the same philosophy as in plaster rectification.
  • the unique tool manufactured by either embodiment of the method ensures that the medical device is specifically tailored to the individual.
  • the medical device may be for use externally or internally of the subject.
  • the medical device may be for use on, or for a subject's limb, for example the arm, leg or foot.
  • the device is an orthosis or a prosthesis.
  • the medical device produced using the method does not comprise any of the polymeric material.
  • the layer of polymeric material comprises a layer with a thickness between o.i mm and 10 mm, more preferably between 0.3 mm and 8 mm, even more preferably between 0.5 mm and 6 mm, and more preferably between 0.7 mm and 4 mm.
  • the layer of polypropylene comprises a layer with a thickness between 0.8 mm and 3 mm, more preferably between 0.9 mm and 2.5 mm, and most preferably between 1 mm and 2 mm.
  • the medical device produced using the method comprises at least a portion of the polymeric material.
  • the layer of polymeric material comprises a layer with a thickness between 0.1 mm and 20 mm, more preferably between 0.3 mm and 17.5 mm, even more preferably between 0.4 mm and 15 mm, and more preferably between 0.5 mm and 12.5 mm.
  • the layer of polypropylene comprises a layer with a thickness between 1 mm and 10 mm, more preferably between 2 mm and 8 mm, and most preferably between 3 mm and 6 mm.
  • the polymeric material is preferably thermoformable. Hence, the polymeric material may be heated to a temperature at which it becomes malleable, and allows drape vacuum forming.
  • the polymeric material is resistant to adhesion to epoxy based adhesives. Hence, it is capable of being released from epoxy 'pre-preg' resin systems, as described below.
  • the polymeric material may comprise nylon, polyethylene, polytetrafluoroethylene and/or polypropylene.
  • the polymeric material may comprise a homopolymer material, random copolymer material or block copolymer material.
  • the polymeric material comprises polypropylene.
  • the layer of polypropylene may comprise homopolymer polypropylene, random copolymer polypropylene or block copolymer polypropylene.
  • the layer of polypropylene comprises homopolymer polypropylene.
  • One preferred polymeric material that may be used in accordance with the invention is that which is known as 2mm homopolymer, which may be obtained from www.directplastics.co.uk.
  • the polymeric material does not comprise polyvinyl acetate (PVA).
  • the method comprises heating the polymeric material before the step of contacting a portion of the tool with the material.
  • the method comprises heating the polymeric material to a temperature of at least 150 °C, more preferably at least 175 °C, and most preferably at least 190 °C.
  • the method comprises heating the polymeric material for at least 20 minutes, more preferably at least 25 minutes, and most preferably at least 30 minutes.
  • the polymeric material may be heated in a halogen oven, a convection oven or an infrared oven.
  • the polymeric material is heated in an infrared oven.
  • the step of contacting a portion of the tool with the layer of polymeric material is conducted immediately after the step of heating the polymeric material.
  • the heated polymeric material is draped over the tool.
  • a seal is created by joining the polymeric material with itself.
  • the seal is created by joining the partially molten polymeric material around the tool with light pressure.
  • the technician will be wearing gloves in his hands, which may be used to apply the pressure required to create the seal.
  • a seal is also preferably created around the vacuum tube.
  • the vacuum tube serves two functions. Firstly, it is hollow and provides the source of the vacuum, as discussed below. Secondly, it provides a means by which the tool can be held or gripped during the method, for example by the technician's hand or in a vice.
  • any excess polymeric material is cut away for practical reasons, as it is only waste.
  • the excess is cut away after the seal has been created, and before the polymeric material has cooled and hardened.
  • the vacuum pressure is sufficient to form it.
  • the method comprises applying a vacuum to the polymeric material, and thereby causing the polymeric material to fit closely around the tool.
  • the plaster or polyurethane tool has a hollow tube inserted into it. This allows ease of handling, and also allows the tube to be connected to a vacuum system.
  • the tube may be connected to a rotary vane vacuum pump.
  • the source of the vacuum could be a domestic vacuum cleaner.
  • One hole in the tube is sufficient to create sufficient vacuum pressure to seal the polymeric material.
  • the vacuum is maintained until the polymeric material has cooled.
  • the polymeric material may have cooled when it has reached ambient temperature, i.e. about 21 °C.
  • the length of time for allowing cooling is usually dependent upon ambient room temperature. For example, if the polymeric material is maintained at about 21 °C, it can take about 45 minutes to cool sufficiently. It is important not to rush this cooling process for fear of weakening the polymeric material, such that it could crack.
  • the method preferably comprises removing the vacuum, preferably before the curing step.
  • the tool is then no longer connected to a vacuum and may therefore be moved around freely and the polymeric material retains the shape of the tool.
  • the tool may be moved to an area where the curable material is contacted with the layer of polymeric material.
  • the curable material may be either a UV-curable or a heat-curable material.
  • the curable material is in sheet form.
  • the material may be tensioned after it has been applied to the polymeric material. In other embodiments, tensioning is not required.
  • the curable material is a composite sheet including an inner core of fibre substrate impregnated with a polymer resin.
  • the composite sheet may be of the type often referred to as a "pre-preg", in that it comprises a fibre composite sheet p re-impregnated with resin.
  • Carbon, aramid, high molecular weight polyethylene and/or glass fibres are preferred. Each of these fibres may be impregnated with a similar resin system, such as an epoxy based system.
  • the curable material i.e. resin
  • the curable material is preferably uncured at the time of manipulation.
  • this allows the curable material to be carefully worked around the 3D shape of the tool.
  • the fibres are contacted with the polymeric material covering the tool surface.
  • the fibres are usually woven like a fabric, and so
  • the fibres are preferably manipulated, such that they form a three dimensional shape represented by the tool. Due to the tacky uncured resin, the pre- preg holds its position well on the tool surface. The desired thickness is obtained by adding multiple layers of pre-preg to a pre-determined 'fibre lay-up design'.
  • One preferred curable material that may be used in accordance with the invention is a carbon fibre epoxy resin system pre-preg, which may be obtained from Gurit, Cytex or PRF Composites in which the resin is curable at about 120 °C.
  • the curable material may be covered by a releasable membrane.
  • the membrane may comprise a polymer film.
  • the polymer film may comprise a fluorinated polymer, such as polytetrafluoroethylene or fluorinated ethylene propylene. Alternatively, or
  • the film may comprise a shrinking film.
  • the shrinking film may comprise poly (vinyl chloride) PVC) or a polyolefin.
  • the polymer film comprises a polytetrafluoroethylene-based film.
  • a vacuum-permeable breather fabric may be placed over the releasable membrane.
  • the step of curing the fibres may comprise either UV-curing or heat-curing the curable material.
  • the resultant structure may then be placed in a heat-tolerant vacuum bag comprising a vacuum valve.
  • the vacuum bag-enclosed tool may be placed in an oven (e.g. convection oven) or an autoclave.
  • the oven or autoclave has a vacuum tube entering into it through an aperture in one side thereof.
  • the tool is preferably placed under vacuum pressure whilst in the oven or autoclave.
  • the vacuum pressurises the pre-preg thereby sucking out any air trapped within the substrate consisting of the tool and curable material. Any resultant air bubbles would only act to weaken the structure.
  • the tool may then be heated for at least 10 minutes, 20 minutes, 30 minutes, 40 minutes or 50 minutes.
  • the tool is heated for at least 1 hour. More preferably, the tool is heated for at least 2 hours.
  • the tool may then be heated for between 10 minutes and 7 hours, between 20 minutes and 6 hours, between 30 minutes and 5 hours, between 40 minutes and 4 hours or between 50 minutes and 3 hours.
  • the tool is heated for between 1 and 2 hours.
  • the tool is heated at at least 50 °C, at least 60 °C, at least 70 °C, at least 80 °C or at least 90 °C. More preferably, the tool is heated at at least 100 °C or 110 °C. Most preferably, the tool is heated at at least 120 °C.
  • the tool is heated at between 40 °C and 200 °C, between 50 °C and 190 °C, between 6o°C and i8o°C, between 70°C and 170°C, between 8o°C and i6o°C or between 90 °C and 150 °C. More preferably, the tool is heated at between 100 °C and 140 °C or between 110 °C and 130 °C. Most preferably, the tool is heated at about 120 °C. In a most preferred embodiment, the tool is heated for at least 1 or 2 hours at about 120 °C.
  • the method may comprise repeating the steps of laying the curable material on at least a portion of the layer of polymeric material and curing the material.
  • the resultant medical device is ultimately removed 'demoulded' from the tool by prying it therefrom.
  • the method may comprise removing the polymeric material from the tool.
  • the method Prior to removing the polymeric material from the tool, the method may comprise defining trim lines on the polymeric material.
  • the method may comprise cutting the polymeric material along the trim lines, and removing it from the tool.
  • the polymeric material may be removed from the tool using a blade or an oscillating saw.
  • the cured material may be demoulded from the tool before the polymeric material is removed from the tool.
  • the method may comprise removing the polymeric material from the tool while the cured material is disposed thereon.
  • this method may be used in embodiments where the geometric design of the medical device may 'lock' the polymeric material into the cured material without bonding agents.
  • the polymeric material and cured material may be fixed together using bonding agents to create the medical device.
  • the bond agents may comprise glue, such as hot glue, or screws and rivets.
  • the bond agents comprise screws and rivets.
  • the method can be used to produce a partially formed orthosis or prosthesis which is then fitted to the individual.
  • This enables any minor changes to be made to the design, such as the shape or stiffness, before many hours are spent forming the completed orthosis or prosthesis.
  • the composite material used in the invention is not heat-remouldable, and so it is not possible to heat it and reform it as is possible with polymeric material. However, if shape adjustment of the medical device is required, it is possible to remove the incorrect section of the material by cutting it away.
  • the tool may then be re-shaped in the localised area by using high temperature wax, putty or plaster. Once this has been done, pre-preg maybe applied to the area and cured using the processes described above, thereby achieving a re-shaped medical device.
  • the inventors have also developed an apparatus for forming a medical device using the method of the first aspect.
  • an apparatus for forming a medical device comprising: - - means for contacting a portion of a tool corresponding to a subject's body part with a layer of polymeric material configured to retain the shape of the tool in the absence of a vacuum;
  • the apparatus of the second aspect is preferably used for carrying out the method of the first aspect. All of the features described herein (including any accompanying claims, abstract and drawings), and/ or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and/ or steps are mutually exclusive.
  • Figure l is a plaster cast of a patient's leg forming a tool that is used for preparing an orthotic device
  • Figure 2 is the plaster cast of a patient's leg of Figure ⁇ with a polymeric sheet fitted thereto;
  • Figure 3 is an orthotic composite made using the method of the present invention.
  • Figure 4 shows an orthosis comprising a composite portion and a thermoplastic portion.
  • Plaster of Paris is safe, adaptable and cheap. Accordingly, Plaster of Paris is used in orthotic and prosthetic manufacturing to both capture the shape of a person's anatomy and modify a workable and unique 'tool' 2 for manufacturing.
  • An example of a tool 2 used to make an orthosis 4 is shown in Figure 1.
  • a unique tool 2 is made for each individual who requires the orthosis or prosthesis. For instance, when a tool 2 is needed to manufacture an orthosis, a technician will make the tool 2 using a process generally known as "rectification".
  • the tool 2 is manufactured as follows. A plaster bandage is used to produce a negative plaster mould of the intended subject's limb.
  • the negative plaster mould is then filled with liquid plaster whilst a hollow metal vacuum tube is placed in the space as it is filled.
  • the liquid plaster is allowed to dry, and the original plaster bandage is removed, thereby creating a positive mould, which is an accurate representation of the subject's body part or limb.
  • the technician applies and removes plaster from the positive mould.
  • the technician must be mindful of bony prominences, and areas of the subject's body that are sensitive to pressure. Accordingly, further material is added in these areas to alleviate pressure in the final medical device that is made. Conversely, material is removed from areas of the subject's body that are more tolerant to pressure in order to obtain an intimate fit.
  • a polyurethane milled tool is manufactured for use in the method of the first aspect.
  • a digital scan of the subject's body part or limb is taken with scanning equipment.
  • the shape is 'rectified' using software with the same philosophy as in plaster rectification.
  • the finished tool 2 comprises a plaster portion 5 corresponding in shape to a portion of the client's anatomy, for example an arm, leg or foot.
  • the tool corresponds to a person's foot 7 and lower leg 9.
  • a metal rod 6 extends out from the plaster portion 5, by which the tool 2 can be held steady by locating the metal rod 6 in a clamp 8.
  • the rod 6 is hollow and also provides the source of vacuum pressure, as described below.
  • a 1 to 2 mm thick layer of homopolymer polypropylene sheet 20 is heated in an infrared oven at 190 °C for 30 minutes. When warm, the polypropylene sheet 20 is then draped over the plaster portion 5 of the tool 2 and a seal 21 is created by joining the polypropylene 20 with itself, as shown in Figure 2.
  • the seal 21 is created by joining the sheet 20 with itself.
  • the seal 21 is created by joining the partially molten sheet 20 around the tool 2 with light pressure applied from the technician's glove-protected hands.
  • a seal 21 is also created around the rod 6, i.e. "vacuum tube". A vacuum is then applied to the section of the tool 2 comprising the plaster portion 5 covered by the polypropylene sheet 20, and this causes the polypropylene 20 to fit tightly around the plaster 5, as shown in Figure 2.
  • the plaster or polyurethane tool 2 has a hollow vacuum tube 6 inserted into it. This allows ease of handling, and also allows the tube 6 to be connected to a vacuum system (not shown). For example, the tube 6 can be connected to a rotary vane vacuum pump or a domestic vacuum cleaner.
  • One hole in the tube 6 is usually sufficient to create sufficient vacuum pressure to seal the polypropylene around the tool 2. However, on larger tools 2, it may be preferred to drill into the internal tube 6 in suitable sections in order to spread the vacuum pressure sufficiently.
  • the vacuum is maintained until the polypropylene has cooled, which is usually at ambient or about 2i°C. The length of time for allowing cooling depends upon the ambient room temperature. For example, if the polypropylene is maintained at about 21 °C, it can take about 45 minutes to cool sufficiently.
  • the vacuum is removed and the polypropylene sheet 20 retains the shape of the tool 2.
  • the polypropylene-covered tool 2 can then be moved freely around the workshop using rod 6, as it is no longer tied to the vacuum system.
  • pre-impregnated (pre-preg) carbon fibres 22 are then placed on the polypropylene-covered tool 2 in the desired locations for making the orthosis.
  • the pre-preg carbon fibres 22 are placed on the sole 10 of the foot 7, on a portion 12 of either side of the foot, along the back 14 of the leg 9 and extending around a portion of the calf 16.
  • Carbon, aramid, high molecular weight polyethylene (such as that sold under the trade mark DYNEEMA) and/or glass fibres 22 are preferred.
  • Each of these fibres 22 may be impregnated with a similar resin system, such as an epoxy based system. The resin is uncured at the time of manipulation, and so the fibres 22 are contacted with the tool surface.
  • the fibres 22 are usually woven like a fabric, and so manipulation of the fibre weave over and around polymeric material on the tool may be required.
  • the fibres 22 are manipulated such that they form a three dimensional shape represented by the tool. Due to the tacky uncured resin, the pre-preg holds the position well on the tool surface. The desired thickness is obtained by adding multiple layers of pre-preg to a pre-determined 'fibre lay-up design'.
  • One preferred curable material that may be used is a carbon fibre epoxy resin system pre-preg, which may be obtained from Gurit, Cytex or PRF Composites in which the resin is curable at about 120 °C.
  • the carbon fibres 22 are then cured.
  • the step of curing the fibres can involve either UV- curing or heat-curing the curable material.
  • the pre-preg is wrapped in a releasable membrane, such as a polytetrafluoroethylene-based film.
  • a vacuum-permeable breather fabric is then placed over the releasable membrane, and this resultant structure is then placed in a heat-tolerant vacuum bag comprising a vacuum valve.
  • the vacuum bag-enclosed tool is then placed in a convection oven (or an autoclave).
  • the oven or autoclave has a vacuum tube entering into it through an aperture in one side thereof.
  • the tool 2 is placed under vacuum pressure whilst in the oven or autoclave.
  • the vacuum pressurises the pre-preg thereby sucking out any air trappped within the substrate. Any resultant air bubbles would only act to weaken the structure.
  • the tool 2 may then be heated for at least 1 or 2 hours at 120 °C
  • the curing process does not damage the protective polypropylene layer 20 which is placed over the tool 2. Accordingly, the tool 2 can be used in multiple cure cycles without any adjustment to the tool 2 or the protective polypropylene layer 20 being necessary.
  • the resultant orthosis is removed 'demoulded' from the tool 2 by mechanically prying it off the tool 2.
  • the polypropylene sheet 20 does not stick to the resin, and so this process is straightforward unless there is some sort of geometry that 'locks' the device in place.
  • the orthoses usually requires their edges to be smoothed. Then, straps and padding etc., as necessary, can be added as indicated by the design.
  • Preparing a prosthesis is essentially the same as making an orthosis. Though a prosthesis often has a geometry that 'locks' the device onto the tool. If this happens, the tool 2 can be destroyed to remove device. Alternatively, the device can be cured with 'seams' that separate during the demoulding process. These seams can be strengthened with adhesion techniques whilst the prosthesis is removed from the tool 2.
  • the resultant orthosis is 'demoulded' from the tool 2 by mechanically prying it off the tool 2.
  • the edges of the resultant orthoses may be smoothed and straps 108 and padding etc., as necessary, can be added as indicated by the design.
  • the curing process does not damage the protective polypropylene layer 20 which is placed over the tool 2. Accordingly, instead of using the tool 2 in multiple cycles, as described above, the polypropylene layer 20 can be removed from the tool 2 and cut to size. This can then be used to form an orthosis 102 comprising a composite component 104, which is formed by the cured pre-preg 22, and a
  • thermoplastic component 106 which is formed from the polypropylene layer 20, as shown in Figure 4. Summary
  • an orthosis 4 or prosthesis more adaptable. Accordingly, it is possible to cure a pre-preg layer to produce a partially formed orthosis or prosthesis. A technician can then accurately add additional pre-preg material 22 to the partially formed orthosis or prosthesis to define external components once the additional pre- preg material is cured. Alternatively, or additionally, the method can be used to produce a partially formed orthosis or prosthesis which is then fitted to a client.

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

Abstract

L'invention concerne un procédé de fabrication d'un dispositif médical. Le procédé comprend la mise en contact d'une partie d'un outil correspondant à une partie du corps d'un sujet avec une couche de matériau polymère conçu pour conserver la forme de l'outil en l'absence de vide. Le procédé comprend en outre la mise en contact d'au moins une partie de la couche de matériau polymère avec un matériau durcissable et ensuite le durcissement du matériau durcissable pour qu'il devienne rigide afin de créer ainsi un dispositif médical.
PCT/GB2016/053979 2015-12-18 2016-12-19 Dispositif médical WO2017103621A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP16815920.0A EP3389973A1 (fr) 2015-12-18 2016-12-19 Dispositif médical

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1522383.7A GB2535612B (en) 2015-12-18 2015-12-18 Method and apparatus for making an orthotic or prosthetic device
GB1522383.7 2015-12-18

Publications (1)

Publication Number Publication Date
WO2017103621A1 true WO2017103621A1 (fr) 2017-06-22

Family

ID=55311221

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2016/053979 WO2017103621A1 (fr) 2015-12-18 2016-12-19 Dispositif médical

Country Status (3)

Country Link
EP (1) EP3389973A1 (fr)
GB (1) GB2535612B (fr)
WO (1) WO2017103621A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11484426B2 (en) 2017-05-12 2022-11-01 Ast Design, Llc Foot ankle orthoses
US11857448B2 (en) 2018-02-02 2024-01-02 Otto Bock Healthcare Lp Methods and apparatus for treating osteoarthritis of the knee
US11872151B2 (en) 2017-05-12 2024-01-16 Ast Design, Llc Method of manufacturing an ankle foot orthosis

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2327378A (en) * 1996-09-19 1999-01-27 Rothschild S Orthopedics Forming a natural foot orthosis by injection moulding
US20040260403A1 (en) * 2003-06-20 2004-12-23 Patterson William Stan Prosthetic socket with self-contained vacuum reservoir
US7311866B1 (en) * 2002-06-25 2007-12-25 Ebi, L.P. Method for creating a mold for a knee brace and a knee brace
WO2014206470A1 (fr) * 2013-06-27 2014-12-31 Swissleg Sagl Prothèse de jambe et procédé de fabrication correspondant

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5316545A (en) * 1991-09-06 1994-05-31 Nicole A. Polymeric orthotic devices and method of formation
US5593456A (en) * 1994-05-17 1997-01-14 Crp, Inc. Foot and leg prosthesis and method of making same
US20060079819A1 (en) * 2004-10-13 2006-04-13 Bsn Medical, Inc. Orthopedic splint

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2327378A (en) * 1996-09-19 1999-01-27 Rothschild S Orthopedics Forming a natural foot orthosis by injection moulding
US7311866B1 (en) * 2002-06-25 2007-12-25 Ebi, L.P. Method for creating a mold for a knee brace and a knee brace
US20040260403A1 (en) * 2003-06-20 2004-12-23 Patterson William Stan Prosthetic socket with self-contained vacuum reservoir
WO2014206470A1 (fr) * 2013-06-27 2014-12-31 Swissleg Sagl Prothèse de jambe et procédé de fabrication correspondant

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11484426B2 (en) 2017-05-12 2022-11-01 Ast Design, Llc Foot ankle orthoses
US11872151B2 (en) 2017-05-12 2024-01-16 Ast Design, Llc Method of manufacturing an ankle foot orthosis
US11857448B2 (en) 2018-02-02 2024-01-02 Otto Bock Healthcare Lp Methods and apparatus for treating osteoarthritis of the knee

Also Published As

Publication number Publication date
GB2535612A (en) 2016-08-24
GB2535612B (en) 2017-03-01
GB201522383D0 (en) 2016-02-03
EP3389973A1 (fr) 2018-10-24

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