EP3817700A1 - Dispositif orthétique, système orthétique et leurs procédés de fabrication et d'utilisation - Google Patents

Dispositif orthétique, système orthétique et leurs procédés de fabrication et d'utilisation

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Publication number
EP3817700A1
EP3817700A1 EP19779088.4A EP19779088A EP3817700A1 EP 3817700 A1 EP3817700 A1 EP 3817700A1 EP 19779088 A EP19779088 A EP 19779088A EP 3817700 A1 EP3817700 A1 EP 3817700A1
Authority
EP
European Patent Office
Prior art keywords
orthosis
sheet
body part
pla
splint
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.)
Withdrawn
Application number
EP19779088.4A
Other languages
German (de)
English (en)
Inventor
P.C. Aidplex
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority claimed from PCT/IB2019/000676 external-priority patent/WO2020008253A1/fr
Publication of EP3817700A1 publication Critical patent/EP3817700A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/04—Plaster of Paris bandages; Other stiffening bandages
    • 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
    • A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • A61F5/058—Splints
    • A61F5/05825—Strips of substantially planar form
    • 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
    • A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • A61F5/058—Splints
    • A61F5/05841—Splints for the limbs
    • A61F5/05858—Splints for the limbs for the arms
    • A61F5/05866—Splints for the limbs for the arms for wrists, hands, fingers or thumbs
    • 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

Definitions

  • the present disclosure relates to the medical field and, more specifically to an orthotic device in the form of a mo!dahle splint for immobilizing, embracing and supporting a body part, preferably comprising an articulation, of a human or animal.
  • the present disclosure also relates to an orthotic system including the orthotic device and to methods of manufacture and use thereof.
  • Immobilization devices such as a cast, a splint, a brace (orthosis) and stiffening apparatuses are used to impart a desired position to supported portion of the body or to immobilize the supported portion relative to other parts of the body.
  • plaster casting materials have been used because they are very low cost. However, plaster casting materials are heavy and cannot be cleaned or easily removed. Recently, plaster casting materials have been replaced by synthetic casting materials which are lighter in weight and can be cleaned but have a rough exterior surface and are still relatively heavy and bulky.
  • Plaster materials are associated with important disadvantages such as its weight, the development of dust, the occurrence of sharp and hard edges, and the time required for its application.
  • a east or other immobilization device be removed for medical consultation or exercise by a therapist and then put back on the patient.
  • the plaster material easts cannot be removed intact and put back on the patient.
  • Braces have been described which are made of a sheet material impregnated or coated with a curable resin.
  • a known orthopedic casting article comprises a flexible sheet material impregnated or coated with two different resins.
  • the article may he in the form of an orthopedic casting tape or a protective pad comprising a fabric hacking that is longitudinally impregnated or coated with two different curable resins, preferably water-curable resins.
  • the orthopedic casts are made by providing a curable casting tape; initiating the cure of the casting tape, e.g., by exposing the casting tape to water; and allowing the casting tape to cure to form an orthopedic cast.
  • Another known orthopedic casting article comprises a curable resin (e.g., a water curable resin) and a filler (e.g., fibrous materials) associated with the resin.
  • a curable resin e.g., a water curable resin
  • a filler e.g., fibrous materials
  • Yet another known orthopedic cast comprises a sheet formed of an open-ceiled foam sheet impregnated with a water curable resin. Upon activation of the resin impregnated foam sheet and molding the same around the body pan, an orthopedic splint is formed.
  • a common drawback of the braces comprising a curable resin is that the curing process takes a considerably time, e.g., around 30 minutes or more, before an orthopedic cast functional enough to support the injury is obtained. Moreover, the curing process is irreversible and it is impossible to shape the cured cast or splint in another position. Therefore the cast or splint has to be changed, i.e., a a new cast or splint needs to be applied at different phases of the injur healing process. In addition, to supply the cast or splint a technician needs to wear gloves.
  • easting or splinting may be very difficult, especially when it is required to build casts having different angles, e.g., a 90° angle between the foot joint and low ' leg, since at the same time it is necessary to make sure that a good angle is obtained, that the lamination and pressure is optimal, and that contours are followed.
  • a cast or splint like those available in the prior art, wherein the casting material consists of a water-curable resin, and/or currently used products such as synthetic casts and/or P.O.P. (Plaster of Paris) have a cure (setting) time that can take more than one hour.
  • thermoplastic materials are now being used for forming casts and braces and other immobilization devices.
  • These thermoplastic materials can be produced in extruded sheets which, when brought to a rneit point (50° C to 100° €), can be molded and manipulated to conform to and shape around a body part, such as a limb, and then allowed to cool to hardness. These materials can also be reheated, brought back to their original shape and then remolded into a different shape.
  • the thermoplastic materials provide many advantages including sim plicity of use and ease of cleaning.
  • thermoplastic apparatus for immobilization or support of a body part of a human or animal is formed from a sheet of thermoplastic moidable material that is substantially rigid at ambient temperatures and pliable at higher temperatures.
  • the apparatus consists of two elements, which are fastened to one another by means of a fastener for fastening.
  • the fastener is directly attached to the thermoplastic material, so that the fastener allows the thermoplastic apparatus to be removed from and put back on the human or animal body part.
  • braces made of thermoplastic material are difficult to undergo slight movements, e.g. swelling.
  • differences in pressure in the brace (orthosis) e.g., due to movements of a patient carrying the brace or due to swelling of the body part, may induce deformations or distortions in the brace configuration and/or create pressure contacts on the body part.
  • application of the above-mentioned type of braces on impaired limbs, arms or other body parts involves the adjustment and fastening of the fasteners to a patient, which is a time-consuming process.
  • Another problem associated with this type of braces is that they are relatively heavy.
  • cork-li ke material for manufacturing braces and the like.
  • splint made of a disposable material containing a cork-like material such as EVA (ethylene vinyl acetate).
  • EVA ethylene vinyl acetate
  • braces or the like which are capable of some oxygen/air diffusion. It has been shown in the art that braces that are not sufficiently breathable can cause skin irritation, skin maceration, or skin dryness.
  • braces made of softer materials may be or become too soft once applied on a body part, and loose sufficient hardness. Such braces may easily bent or form folds or pressure contacts on the body part, which may result in injury' or sub-optimal recovery of the injured body part.
  • the present disclosure relates to an orthotic device formed of a single sheet of moldable Polylactic Acid (PLA) material for embracing and supporting a body part of a human or animal comprising an articulation and configured to maintain the body part in an optimal position for development and treatment.
  • PLA Polylactic Acid
  • the PLA sheet is breathable, light-weight, sanitary and moisture-resistant.
  • the PLA sheet is formed with a plurality of perforations uniformly distributed over the total surface are of the PLA sheets Preferably, the perforations are distributed over 75% to 95% of the total surface area of the PLA sheet.
  • the PLA sheet has a thickness in the range of about
  • the PLA sheet is breathable, light-weight, waterproof and recyclable.
  • the PLA sheet is formed with at least one aperture for passage therethrough of a body part of the human or animal.
  • the PLA sheet is pre-cut to a preselected configuration suitable for forming to shape for a custom application.
  • the present disclosure is directed to an orthotic system including the orthotic device according to any of the foregoing aspect and embodiments.
  • the orthotic system further includes an inner protective layer applied directly onto the body part, and the orthotic device is applied directly onto the inner protective layer.
  • the inner protective layer comprises a bandage.
  • the inner protective layer comprises a single moldabie sheet of polyethylene foam.
  • the orthotic system may further include a fastener for releasably securing the orthotic device onto the body part.
  • the present disclosure is directed to a method of forming a splint using the orthotic device according to the foregoing aspects and embodiments.
  • Still another aspect of the present disclosure relates to methods for manufacturing the orthotic device according to the foregoing aspects and embodiments.
  • Fig. 1 is a front view of an orthotic device in the form of a moldable splint according to an embodiment of the present disclosure which is suitable for being applied in support of a wrist articulation.
  • Fig. 2 is a diagrammatic view showing a heating procedure for the moldable splint of Fig. 1 using hot water.
  • Fig. 3 is a diagrammatic view showing a heating procedure for the moldable splint of Fig. 1 using hot air.
  • Fig. 4 is a perspective side view showing the application of an inner protective layer in the form of a bandage on an injured part (e.g., the wrist and forearm) of a patient’s body in preparation for application of the moldable splint of Fig. 1, according to an embodiment of the present disclosure.
  • Fig. 5 is a perspective view of the moldable splint of Fig. 1 being applied on a patient’s body part after application of the inner protective layer.
  • Fig. 6 is a side view of the moldable splint of Fig. 1 mounted onto a wrist and undergoing a heating procedure for molding and shaping about the patient’s wrist.
  • Fig. 7 is a perspective view showing the removal of the applied inner protective layer after forming the moldable splint of Fig. 1 onto the patient’s wrist.
  • Fig. 8 is a perspective view of another embodiment of the use of the moldable splint of Fig. 1 similar to Fig. 7, except that the inner protective layer is not applied and the moldable splint is formed directly on the patient’s wrist and forearm.
  • Fig. 9 is a view similar to Fig. 7 and illustrates another embodiment in which the inner protective layer remains in place and is not removed after formation of the moldable splint.
  • Fig. lOA is a perspective view showing the application of a fastener of a first type over the formed moldable splint shown in Fig. 8 to assist in retaining and secure the moldable splint in place over the patient’s injured part.
  • Fig. 1 OB is a view similar to Fig. 10A showing the fastener completely applied over the moldable splint.
  • Fig. 11 is a perspective view showing the application of the fastener of the first type over the formed moldable splint shown in Fig. 9 to assist in retaining and securing the moldable splint in place over the patient’s injured part.
  • Fig. l2A is a perspective view showing the application of a fastener of a second type over the formed moldable splint shown in Fig. 8 to assist in retaining and secure the moldable splint in place over the patient’s injured part.
  • Fig. 12B is a view similar to Fig. 12A showing the fastener completely applied over the moldable splint.
  • Fig. 13 is a perspective view showing the application of the fastener of the second type over the formed moldable splint shown in Fig. 9 to assist in retaining and secure the moldable splint in place over the patient’s injured part.
  • Fig. 14 is a side view of the moldable splint formed on the patient’s injured part shown in Fig. 8 and illustrating another embodiment in which the fastener is not applied over the formed moldable splint in its final application on the patient’s injured part.
  • Fig. 15 is a side view of the moldable splint formed on the patient’s injured part shown in Fig. 9 and illustrating another embodiment in which the fastener is not applied over the formed moldable splint in its final application on the patient’s injured part.
  • Fig. 16 is a front view of an orthotic device in the form of a moldable splint according to another embodiment of the present disclosure which is suitable for being applied in support of a wrist articulation.
  • Fig. 17 is a front view of an orthotic device in the form of a moldable splint according to another embodiment of the present disclosure which is suitable for being applied in support of a wrist articulation.
  • Fig. 18 is a front view of an orthotic device in the form of a moldable splint according to another embodiment of the present disclosure which is suitable for being applied in support of an ankle articulation.
  • Fig. 19 is a front view of an orthotic device in the form of a moldable splint according to another embodiment of the present disclosure which is suitable for being applied in support of an elbow articulation.
  • Fig. 20 is a flowchart illustrating steps for manufacturing a moldable splint according to an embodiment of the present disclosure.
  • Fig. 21 is a flowchart illustrating steps for manufacturing a moldable splint according to another embodiment of the present disclosure.
  • Fig. 22 is a flowchart illustrating steps for manufacturing a moldable splint according to another embodiment of the present disclosure.
  • Fig. 23 is a flowchart illustrating steps for applying a moldable splint to a patient according to an embodiment of the present disclosure.
  • Fig. 24 is a front view of an inner protective layer for the orthotic system according to another embodiment of the present disclosure.
  • Fig. 25 is a perspective view of the inner protective layer of Fig. 24 being applied on a patient’s body part prior to application of the moldable splint.
  • Fig. 26 is a perspective view showing the moldable splint applied on the patient’s body part directly over the inner protective layer of Figs. 24 and 25.
  • Fig. 27 is a perspective view showing the application of a fastener in the form of an elastic band to assist in retaining and securing the moldable splint in place over the patient’s body part.
  • Fig. 28 is a perspective view similar to Fig. 27, but with a front portion of the moldable splint being cut off to better illustrate the applied inner protective layer.
  • Fig. 29 is a cross-sectional view taken along line 29-29 in Fig. 28.
  • Fig. 30 is a flowchart illustrating steps for applying a moldable splint to a patient in the embodiment of the orthotic system shown in Figs. 24-29.
  • Figs. 1-19 and 24-29 illustrate various embodiments of orthotic devices and systems according to present disclosure, where similar references numerals designate similar elements and features throughout.
  • Figs. 20-22 are flowcharts illustrating various embodiments of methods for manufacturing the orthotic devices according to the present disclosure.
  • Figs. 23 and 30 illustrate embodiments of splinting processes using respective orthoses according to the present disclosure.
  • Fig. 1 is a front view of an orthotic device or orthosis, generally designated at 1, according to an embodiment of a first aspect of the present disclosure.
  • Orthosis 1 is suitable for embracing and supporting a body part of a human or animal comprising an articulation. It is generally prescribed by a physician to provide correction, support, or protection to the body part.
  • Orthosis 1 is prefabricated without a specific patient in mind (i.e., they can fit any patient). It requires the expertise of a therapist to customize die orthosis to a specific patient, including trimming, molding and bending, with or without heat.
  • Orthosis 1 can be molded in the unique skeletal characteristics of a patient’s fractured body part (e.g., wrist, arm, leg, s houl der, head/n eck) .
  • orthosis 1 is in the form of a moldable thermoplastic splint which is suitable for being applied in support of a wrist articulation. It is formed of a single, flat sheet of material which is pre-cut to a preferred configuration that may be later formed to shape for a custom application. Orthosis 1 is light-weight, waterproof, and recyclable, and is designed to maintain the body part in an optimal position for development and treatment.
  • orthosis 1 is made of a thermoplastic material which is moldable (e.g., above 50°C) and breathable.
  • moldable e.g., above 50°C
  • breathable e.g., above 50°C
  • flexible ’ refers to a material which is able to adjust readily to different conditions and in particular refers to a material which is able to easily flex and/or bend without breaking.
  • perforations 2 are provided in the sheet of thermoplastic material for breathability of orthosis 1 once in place on the patient, that is, perforations 2 permit ventilation of the patient’s skin when orthosis 1 is in place upon the body part of the patient. Perforations 2 may also facilitate molding of the sheet when shaping the sheet into a splint on the patient.
  • Perforations 2 are uniformly distributed over the total surface area of orthosis 1. As shown in Fig 1, perforations 2 are generally uniform and have a diameter generally in the range of about 3 mm to about 10 mm. The di meter of perforation 2 may be greater than the diameter values in this range based on an increase in the thickness of orthosis 1.
  • orthosis 1 may be provided without perforations 2, or perforations 2 may be provided only in certain sections of orthosis 1.
  • the orthosis may also be perforated to provide apertures for body parts, such as thumbs, toes, etc.
  • body parts such as thumbs, toes, etc.
  • a single aperture 3 is provided for the patient’s thumb when orthosis 1 is mounted onto the patient’s wrist, as show for example in Fig 5.
  • the thickness of orthosis 1 designated by reference numeral 4 in Fig 1 is preferably in the range of about 1 .5 mm to about 5.0 mm, more preferably in the range of about 1.5 mm to about 3.5 mm, and even more preferably in the range of about 1.8 mm to about 2.0 mm.
  • These preferred thicknesses allow orthosis 1 to be lightweight without compromising the rigidity necessary for the particular use.
  • a thinner orthosis is preferable, and when the orthosis is used as an immobilization orthosis for the lower extremities, a thicker orthosis is preferred.
  • a variety of thicknesses for the orthosis can be formed into sheets in which the appropriate thickness is chosen for the desired support of the pre-selected body part. Selecting a sheet of the appropriate thickness will eliminate excess bulk in the weight of the orthosis.
  • the thermoplastic sheet of material is formed of Poly lactic Acid (PLA). While PLA is a thermoplastic material that allows for flexibility and adjustability, the use of PLA allows the orthosis according to the present disclosure to provide sufficient rigidity to the injured body part.
  • PLA is a thermoplastic material that allows for flexibility and adjustability
  • the use of PLA allows the orthosis according to the present disclosure to provide sufficient rigidity to the injured body part.
  • the inventors of the present disclosure have discovered that PLA imparts a rigidity on the orthosis of the present disclosure that cannot be achieved by other types of thermoplastic materials, such as Polycaprolactone (PCI..), particularly when the orthosis 1 has a thickness within the ranges described above.
  • PCI.. Polycaprolactone
  • the flexible and adjustable nature of the PLA orthosis according to the present disclosure allows the injured body part to which the orthosis is mounted to undergo slight movements, e.g., swelling.
  • the flexibility of the PLA material makes the orthosis of the present disclosure suitably deformable in order to conform to contours and the physical reactions of the treated body part (e.g. swelling/de-swelling) while not compromising the rigidity and hardness of the orthosis.
  • Another advantage of using PLA for the orthosis according to the present disclosure is that PLA is a biodegradable, biocompatible, non-toxic and eco-friendly polymer.
  • polylactic acid As a production process, there are two methods for manufacturing polylactic acid (PLA) from lactic acid: the first method uses the cyclic lactic acid dimer called lactide as an intermediate stage; the second method is direct polymerization of lactic acid. The method using the lactide intermediary yields polylactic acid (PLA) with greater molecular weight.
  • This production process is described in the publication Fibre Chemistry, Vol. 41, Nov. 6, 2009, by Ozan Avinc and Akbar Khoddami, which is incorporated herein by reference in its entirety.
  • Suitable PLA’s for the orthosis according to the present disclosure include the following commercially available products:
  • orthosis 1 according to the present disclosure allows orthosis 1 to be lightweight but also as rigid as required.
  • the orthosis according to the present disclosure is considerably lighter than prior art orthotic devices.
  • orthosis 1 according to the present disclosure preferably has a weight higher than 60 grams but preferably less than 180 grams.
  • Orthosis 1 according to the present disclosure which is preferably made of a single flat sheet of pre-cut PLA material, may be shaped onto the patient’s body part (i.e., the wrist) by applying heat using a heat source.
  • the heat source may be a heated water container 7 as shown in Fig 2.
  • the heat source may be a thermogun 8 as shown in Fig 3.
  • heat orthosis 1 may be used to apply heat orthosis 1 including, but not limited to, a convection oven, a microwave oven and an infrared heater.
  • Orthosis 1 is sufficiently heated to become temporarily elastic so that it can be molded into the shape of the body part to which it is applied. Stated otherwise, orthosis 1 is heated above its glass transition temperature (and below its melting temperature) so as to become ther oformable for shaping within minutes. This temperature should be in the range of about 60°C to about 90°C (target temperatures).
  • orthosis 1 is heated above the PLA glass transition temperature of 60°C. Then orthosis 1 then cools down at room temperature.
  • an inner protective layer is applied directly onto the patient’s body part for protecting the body part from the heat applied by the heat source during the forming/molding process.
  • the inner protective layer is a bandage (e.g., as elastic bandage) that is applied onto the patient’s body part in preparation for forming orthosis 1 on the body- part
  • Fig 4 illustrates the application of a bandage 5 on the patient’s body part 6 in preparation for forming orthosis 1 (Figs. 5-6).
  • the bandage provides further capability to custom fit the orthosis to the particular body part of a particular patient.
  • bandage 5 may be made of a suitable fabric material in the appropriate width, thickness and elasticity suitable for the particular purpose and in a length to adequately wrap over the entire portion of the body part on which the orthosis 1 is to be formed.
  • the combination of orthosis 1 and the inner protective layer, such as bandage 5 described above, defines an orthotic system according to another aspect of the present disclosure.
  • the inner protective layer e.g., bandage
  • orthosis 1 is applied directly onto the patient’s body part 6, as for example shown in Fig. 8.
  • Fig. 14 shows the completed orthosis 1 which has been applied directly over the patient’s body part 6 without bandage 5.
  • orthosis 1 is initially formed so that it does not completely encircle the patient’s body part.
  • an overlap slit or opening 10 is formed by overlap longitudinal edges la, lb (Figs. 1, 5) of orthosis 1 after the initial fomiation of orthosis 1.
  • This gap or slit 10 allows bandage 5 to be removed, such as by using a cutting device 9, after application of orthosis 1 , as for example shown in Fig. 7.
  • bandage 5 is not removed and remains on the patient’s body part after formation of orthosis 1, as for example shown in Fig. 9.
  • Figs. 14-15 show the completed orthosis 1 one with (Fig. 15) and without (Fig. 14) bandage 5 applied on injured body part 6.
  • orthosis 1 becomes warm, soft and pliable and is formed to the intimate shape of the body part to best stabilize the injury under reduction.
  • Overlap opening 5 formed by overlap edges la, lb of orthosis 1, as shown in Fig. 7, is adjustable in circumference.
  • orthosis 1 is best formed when warm and pliable by applying compressive circumferential force. Once orthosis 1 is cool and rigid in a few moments, this compression can be removed.
  • various means are provided for applying the requisite compressive force to orthosis 1.
  • compression is applied to orthosis 1 by quickly wrapping an elastic band 11, as a fastener of the first type, around the warm and pliable orthosis 1 as soon as it is installed, as for example shown in Fig 10A (embodiment of orthosis 1 without use of bandage 5) and Fig. 11 (embodiment of orthosis 1 using bandage 5).
  • Elastic band 1 1 may be made of a fabric or rubberized material in the appropriate width, thickness and elasticity suitable for the particular purpose and in a length to adequately wrap over the entire orthosis 1. Compressive pressure can be varied simply by pulling on band 1 1 as it is wrapped, as shown in Fig. 10.
  • elastic band 11 provides further capability to custo fit orthosis 1 to body part 6 of a particular patient. After orthosis 1 is cooled, band 11 is removed as shown for example in Fig. 14 (embodiment of orthosis 1 without use of bandage 5) and Fig. 15 (embodiment of orthosis 1 using bandage 5).
  • orthosis 1 is completed on injured body part 6 by re!easah!y securing orthosis 1 with a fastener.
  • one type of fastener may be in form of an elastic band such as described above for elastic band 11.
  • elastic band 11 may be completely applied and retained (i.e., is not removed) over orthosis 1 to secure orthosis 1 about body part 6 as shown in Fig. 10B.
  • the combination of orthosis 1 and the fastener e.g., elastic band 11
  • the inner protective layer e.g., bandage 5 as described above, defines an orthotic system according to another aspect of the present disclosure.
  • Figs. 12 A, 12B and 13 show another embodiment of a fastener for reieasably securing orthosis 1 about body part. 6
  • the fastener is in the form of a retaining strap 12 as shown in Fig. 12 (embodiment of orthosis 1 without use of bandage 5) and fug. 13 (embodiment of orthosis using bandage 5).
  • retaining strap 12 comprises a continuous loop of fabric suitable for hook and loop fastening (e.g., Velcro strap).
  • Figs. 16-19 show alternative embodiments of the orthosis, generally designated with respective reference numerals 13-16, according to the present disclosure for embracing and supporting a body part of a human or animal comprising an articulation.
  • Orthosis 13 shown in Fig. 16 is suitable for being applied in support of a wrist articulation.
  • Orthosis 13 is formed with a single aperture 3 provided for the patient’s thumb, and perforations l3b similar to perforations 2 as described above for orthosis 1 with reference to Fig. 1.
  • Orthosis 13 has opposing longitudinal sides l3c, l3d formed with undulations and/or curved surface portions to facilitate its application over the patient’s wrist.
  • Orthosis 14 shown in Fig. 17 is also suitable for being applied in support of a wrist articulation.
  • Orthosis 14 is formed with a single aperture l4a provided for the patient’s thumb, and perforations l4b similar to perforations 2 as described above for orthosis 1 with reference to Fig. 1.
  • orthosis 14 has opposing longitudinal sides l4c, l4d formed with undulations and/or curved surface portions as shown in Fig. 17.
  • Orthosis 14 and orthosis 13 are similar to one another, except that they have somewhat different outer peripheral structural configurations as defined by their respective opposing longitudinal sides.
  • Orthosis 15 shown in Fig. 18 is suitable for being applied in support of an ankle articulation.
  • Orthosis 15 is formed with a single aperture l5a for a body part and perforations 15b similar to perforations 2 as described above for orthosis 1 with reference to Fig. 1.
  • Orthosis 15 has a first part with opposing longitudinal side portions l5c, 15d, a second part with opposing longitudinal side portions l5e, l5f, and a third part with opposing longitudinal side portions 15h, 15i.
  • Opposing open slits 15g are formed at an intersection between the first and second parts of orthosis 15.
  • slits 15g The purpose/function of slits 15g is for being able to fold the material of orthosis 15 when it is pliable without forming edges and making it too thick.
  • Opposing longitudinal sides l5c, 15d are generally linear and parallel to one another.
  • Opposing longitudinal sides 15h, 15i are generally linear and parallel to one another.
  • Opposing longitudinal sides l5e, 15f are disposed between opposing longitudinal sides l5c, 15d and 15h, 15i and are formed with undulations and/or curved surface portions as shown in Fig. 18.
  • Aperture l5a is formed in the first portion of orthosis 15 proximate the intersection between the first and second portions.
  • Orthosis 15 is symmetrical about a line extending through a center of aperture l5a and parallel to opposing longitudinal sides l5c, 15d and l5e, 15f
  • Orthosis 16 shown in Fig. 19 is suitable for being applied in support of an elbow articulation.
  • Orthosis 16 has a first part formed with two apertures l6a, l6b and a second part separated from the first part by opposing open slits l6d similar in structure and function as opposing open slits 15g shown in Fig. 18.
  • the first and second parts of orthosis 16 are formed with perforations l6c similar to perforations 2 as described above for orthosis 1 with reference to Fig. 1.
  • Aperture l6b is provided proximate to and closer to opposing open slits l6d than aperture l6a.
  • the first and second parts of orthosis 16 have different lengths and, in this embodiment, the first part is longer than the second part as shown in Fig. 19.
  • orthoses 13-16 in Figs. 16-19 are the same as for orthosis 1 described above with reference to Figs. 1-14.
  • orthoses 15 and 16 shown in Figs. 18 and 19 differ from orthoses 1, 13 and 14 in that orthoses 15 and 16 are further provided with slits 15g, 16d, respectively, whose purpose/function is to facilitate folding of the orthosis material when it is pliable without forming edges and making it to thick as described above.
  • Orthosis 16 shown in Fig. 19 further differs from orthoses 1 and 13-15 in that orthosis 16 is provide with two apertures for body parts instead of one.
  • Figs. 20-22 are flowcharts illustrating methods for manufacturing the orthotie device according to various embodiments of the present disclosure.
  • the flowchart in Fig. 20 illustrates steps for manufacturing a FLA splint according to the present disclosure by a 3D printing process.
  • New developments in 3D printing technologies offer multiple possible new frontiers to Improve patient care, satisfaction, and offer potential financial and investment opportunities.
  • the 3D printing process starts at Step 30.
  • the method includes heating a 3D printer extruder (Step 31), extruding the FLA filament (Step 32), adding the PLA material layer by layer (Step 33) until the splint is manufactured (Step 34).
  • Step 35 in designates the end of the 3D printing process.
  • the flowchart in Fig. 21 illustrates steps for manufacturing a PLA splint according to the present disclosure by an extrusion molding process.
  • the extrusion molding process starts at Step 40.
  • PLA pellets are added inside a heated barrel (Step 41) and the resulting material is injected inside a die to form a thermoplastic sheet (Step 42).
  • the thermoplastic sheet is then removed from the die (Step 43) and is allowed to cool down (Step 44). Thereafter, the corresponding holes and perforations for the splint as described above are formed in the thermoplastic sheet with a cutting machine (e.g., by CMC machining, pressurized water, laser, etc.) (Step 45).
  • the thermoplastic sheet is then subjected to a cutting operation to provide the splints (Step 46), resulting in the manufacture of the splints (Step 47).
  • Step 48 in designates the end of the extrusion molding process.
  • Hie flowchart in Fig. 22 illustrates steps for manufacturing a PLA splint according to the present disclosure by an injection molding process.
  • the injection molding process starts at Step 61.
  • a mold is prepared from a metal (Step 62).
  • FLA pellets are added inside a heated barrel (Step 63) and the material is subjected to a melting operation (Step 64).
  • the melted material is then injected inside of the mold (Step 65).
  • the melted material Is then allowed to cool inside of the mold (Step 66), resulting in the manufacture of the splint (Step 66).
  • Step 48 in designates the end of the extrusion molding process.
  • the PLA splints manufactured by any of the foregoing methods according to the present disclosure exhibit the various preferred structural characteristics and advantages described above with reference to Figs. 1-19.
  • Fig 23 is a flowchart illustrating an embodiment of a splinting process using the orthosis (splint) according to the present disclosure. The process will be described with reference to Figs. 1 -1 5
  • orthosis 1 (splint) according to the present disclosure is first provided (Step 51 ).
  • Orthosis 1 is provided as a kit to the individual, the orthopedic specialist, physician, technician, first responder or other entity.
  • the kit further includes an inner protective layer (e.g., elastic bandage 5) and a fastener (e.g., elastic band 1 1 or retaining strap 12) as describe above which, together with orthosis 1, defines an orthotie system according to the present disclosure.
  • the appropriate kit type and size for the injured body part to be supported is selected.
  • the orthosis is applied on the protective layer (Figs. 6, 7, 9, 1 1 , 13, 15) or directly on the injured body part 6 (Figs. 8, 1 (3, 12, 14).
  • bandage 5 (Fig. 4) as the inner protective layer is then applied to injured body part 6 (wrist) (Step 52).
  • a heat source is then applied to the orthosis to until the orthosis is sufficiently pliable (i.e., to induce elasticity) to allow it to be molded into the shape of the body part to which it is applied (Step 53).
  • orthosis 1 is heated above its glass transition temperature (and below its melting temperature) so as to become thermoform able for shaping within minutes. This temperature should be in the range of about 60°C to about 90°C (target temperatures).
  • the heat source can be hot water (Fig. 2) or a thermogun (Fig. 3). Alternatively, the heat source can be an oven or microwave.
  • orthosis 1 is sufficiently heated ami pliable, approximately 5-10 minutes, for example, it is mounted and molded onto injured body part 6 (Step 54; Figs. 5-6).
  • orthosis 1 is mounted directly onto bandage 5 (Fig. 9). If bandage 5 is not used, orthosis 1 is mounted directly onto injured body part 6 (Fig. 8). In this state, the heated orthosis 1 is manipulated to form a physiological conforming splint on injured body part 6. Gentle manual pressure may be used to form the splint into the correct shape, taking into account the individual characteristics of the intended user and the purpose for the splinting. During this formation process, orthosis 1 is also applied with compressive circumferential force as described above with reference to Figs. I GA and 11, for example. Once orthosis 1 is cool and rigid in a few moments, this compression can be removed.
  • the heated orthosis 1 remains elastic and pliable for several minutes at room temperature, generally long enough for one skilled in the art to form a physiologically conforming splint, but orthosis 1 may be subjected to the heat source at any time to effect additional small changes in the forming/molding of orthosis 1 on injured body part 6 (Step 55) and/or to restore elasticity and prolong working time.
  • the physiological conforming splint is then allowed to cool at room temperature on injured body part 6 to complete the forming process (Step 56).
  • bandage 5 is taken off (Step 57). This can be accomplished, for example, by cutting bandage 5 along overlap slit or opening 10 that is formed by overlap edges 1 a, lb of orthosis 1, as described above, and removing cut pieces of bandage 7 via opening 10 and/or aperture 3 (Fig. 7). Alternatively, bandage 5 may be left on injured body part 6 as an element of the orthotic system according to the present disclosure (Step 58; Fig. 9).
  • the formation of orthosis 1 is done (Step 56).
  • Application of orthosis 1 onto injured body part. 6 is completed by re!easably securing orthosis 1 with a fastener as described above.
  • the fastener may be in the form of a retaining strap 12 as shown in Fig. 12 (embodiment of orthosis 1 without use of bandage 5) or Fig. 13 (embodiment of orthosis using bandage 5).
  • retaining strap 12 comprises a continuous loop of fabric suitable for hook and loop fastening (e.g., Velcro strap).
  • the fastener may be in form of an elastic band such as described above for elastic band 1 1 . For example.
  • fastener may be in the form of a plurality of retaining straps or other suitable means for securing orthosis I onto injured body part 6 without departing from the spirit and scope of the disclosure. It will be appreciated that fastener allows orthosis 1 to be rapidly applied to and removed from injured body part 6 by increasing or decreasing the amount of overlap to more closely fit the injured body part.
  • Figs. 24-30 shows another embodiment of an orthotic system according to the present disclosure.
  • the orthotic system includes an orthotic device according to any of the embodiments described above with reference to Figs. 1-23 and an inner protective layer formed of a single mo!dable sheet of polyethylene foam (PEF).
  • PEF polyethylene foam
  • the PEF sheet is formed of a single, flat sheet of material which is pre-cut to a preferred configuration that may be later formed to shape for a custom application together with a corresponding orthosis according to the present disclosure.
  • the PEF sheet is used in this embodiment in place of the bandage as described above for the previous
  • PEF is a durable (wear and tear resistant), semi-rigid and lightweight closed-cell material. As compared to open-cell foams, PEF exhibits strength, rigidity, and resistance to water and moisture. PEF is also resistant to solvents and petroleum products (including chemicals and grease), and its antimicrobial property inhibits the growth of mold, mildew, and bacteria (i.e., is impervious to mildew, rot and bacteria). As a resilient material, PEF returns to form after compression, while still yielding enough to provide cushion and security where it is needed. In addition to the foregoing, the inventors of the present disclosure have discovered that PEF is particularly suitable for orthopedics due to the following additional characteristics and properties:
  • FIG. 24 is a front view of a PEF sheet, generally designated with numeral 17, as the inner protective layer for the orthotic system according to this embodiment of the present disclosure.
  • PEF sheet 17 is configured for use with orthosis 1 described above with reference to Fig. 1.
  • PEF sheet 17 has substantially the same structural configuration (geometry) as orthosis 1, except that PEF sheet 17 is not provided with apertures 2. In an alternative embodiment, PEF sheet 17 may be provided with apertures 2. The thickness of PEF sheet 17 is preferably in the range of about 1.5 mm to about 5.0 mm, and more preferably about 3 mm.
  • PEF sheet 17 may be adhered to orthosis 1 using a suitable adhesive.
  • a surface of PEF sheet 17 on which orthosis 1 is applied may be coated with an adhesive an adhesive on which a peelable backing sheet is applied.
  • the backing sheet is peeled off and orthosis 1 is attached to the surface of PEF sheet coated with the adhesive.
  • orthosis 1 may be applied directly over PEF sheet 17 without using an adhesive.
  • Fig. 25 shows PEF sheet 17 in the process of being applied on a patient’s body part 6 prior to application of orthosis 1.
  • Fig. 26 shows orthosis 1 applied on body part 6 directly over PEF sheet 17.
  • Fig. 27 shows the use of elastic band 11 to apply compression to orthosis 1 and/or as a fastener to assist in retaining and securing orthosis 1 in place to body part 6, as described above for the embodiment of Fig. 11.
  • Fig. 28 is view similar to Fig. 27, but with a front portion of orthosis 1 removed to better illustrate PEF sheet 17 applied on the body part.
  • Fig. 29 is a cross-sectional view taken along line 29-29 in Fig. 28.
  • PEF sheet 17 may have a configuration other than as shown in Fig. 24.
  • PEF sheet 17 may have a configuration similar to any one of orthosis 13, 14, 15 or 16 shown in Figs. 16-19, respectively, when used in combination with any one of these orthoses to provide the orthotic system.
  • the formation of the orthosis, including application of heat, is as described above with reference to the embodiment shown in Figs. 1-3.
  • PEF sheet 17 effectively protects the body part from the heat during the forming/molding process.
  • PEF sheet 17 provides further capability to custom fit the orthosis to the particular body part of a particular patient.
  • the splint e.g., PL A sheet
  • the splint remains moklable for more than 1 minute, providing sufficient time for medical professionals to mold the splint onto the patient’s injured body part.
  • the resulting orthosis is waterproof and lightweight, as well as resistant to odors, bacteria, mildew and rot and with increased sock absorption and vibration dampening properties, among other properties and characteristic described above for PEF sheet 17.
  • Fig. 30 is a flowchart illustrating steps for applying a moldable splint to a patient in the embodiment of the orthotic system shown in Figs. 24-29.
  • Steps 70, 71 and 73-78 are the same as described above for Steps 50-51, 53-56 and 59-60, respectively, with reference to the splinting process of Fig. 23.
  • Step 72 in Fig. 30 differs from Step 52 in Fig. 23 in that PEF sheet 17 is applied on the injured body part instead of the bandage.
  • Another difference between the splinting processes of Figs. 23 and 30 is that unlike the option to take off the bandage in Step 57 of Fig. 23, PEF sheet 17 is not removed prior to the end of the splinting process (Step 78). Stated otherwise, PEF sheet 17 is designed to remain in place with the orthosis as part of the orthotic system according to the present disclosure.
  • the orthotic device according to the present disclosure may be provided in a relatively flat shape or generally in the shape for a specific body part, such as a wrist, ankle, knee or other body part as well as in general sizes, such as large, medium or small.
  • the orthotic device may also be pre-formed in some cases to approximately fit the body part for trial of size or in the case where a more complex structure requires it.
  • the orthotic device can then be heated and custom shaped as described above to specifically fit the body part that it is to support.
  • the orthosis according to the present disclosure is easy and fast to use since it is formed of a pre-cut single sheet of material.
  • the orthosis is also reliable to use, due to its anatomical design, with a high level of patient comfort.
  • it is required to change the angle of the injured body part, and this can be achieved with the orthosis of the present disclosure because it can be reshaped a number of times (e.g.., more than ten times) to adopt another required position.
  • the orthosis according to the present disclosure is reshapeable and reusable.
  • the orthosis of the present disclosure is easy and quick to install.
  • the orthosis offers the advantage of being able to be easily and rapidly removed and reapplied to a human or animal body pan.
  • the orthosis can therefore be recycled during injury healing.
  • the orthosis of the present disclosure is formed of a single sheet of material and not of two or more separate elements which need to be affixed to each other by one or more fastening means, a physiotherapist or physician may rapidly apply and remove the orthosis to/from the injured body part.
  • the orthosis according to the present disclosure is soft when heated in order to provide optimal wearing comfort to the patient.
  • the orthosis is in particular very light, even three to four times lighter than conventional orthotic devices made of thermoplastic materials other than PL-A.
  • the orthosis of the present disclosure is clean and free of dust, translucent for X-rays, ca be heated and formed in situ onto the patient’s body part, can be worn until complete recovery' of the injured body part, and has improved resistance to abrasion as compared to conventional orthotic devices.
  • Another advantages of the orthosis according to the present disclosure is that due to its design it lowers both the cost to manufacture and apply the orthosis on the patient’s body part, as compared with prefabricated orthotie devices, for example.
  • the orthosis formed of a PLA sheet according to the present disclosure is further used in combination with an inner protective layer formed as a PEF sheet as described above with reference to Figs. 24-30.
  • the PLA sheet remains moidable for more than 1 minute, providing more than sufficient time for medical professionals to mold the splint onto the patient’s injured body part.
  • the orthosis as well as the PLA sheet according to the present disclosure can be fabricated in different colors (e.g., fluorescent colors) and sizes for both children and adults.
  • various accessories can be used with the orthosis according to the present disclosure to make each unique.
  • decorative elements may be embedded in the sheet of orthosis material at a depth at which the decorative elements remain joined to the sheet when it is heated and molded into the orthotic shape.
  • Various accessories can also be added to the orthosis (e.g., splint) after it is fully set.
  • biometric sensors are incorporated onto the orthosis of the present disclosure to permit doctors to monitor various conditions, including temperature, blood flow, swelling sweating, and mechanical pressure applied by the orthosis.
  • Information obtained by the biometric sensors can be transmitted to a hospital/doctor via the internet to allow monitoring of the patient’s condition.
  • the orthosis according to the present disclosure provides a ready to use orthosis solution to healthcare professionals, as compared to conventional orthotic devices comprised of thermoplastic plates that need cuting and trimming in order to form the orthosis.
  • conventional orthotic devices comprised of thermoplastic plates that need cuting and trimming in order to form the orthosis.
  • the process for forming and applying an orthosis using thermoplastic plates is both time consuming and cumbersome.
  • the orthosis according to the present disclosure can substantially reduce the time it takes to apply the orthosis onto the patient’s injured body part.
  • the ready-to-use nature of the orthosis according to the present disclosure substantially reduces the average application time required by healthcare professionals.
  • the orthosis of the present disclosure is also reusable.
  • the orthosis according to the present disclosure is ready for use anytime needed.
  • the orthosis is not custom, so it can fit any patient. This feature allows doctors and nurses to spend their time more efficiently.
  • the orthosis according to the present disclosure allows healthcare professionals to reduce their costs and limit their inefficiencies, whilst patients are provided with an excellent quality orthotic device.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (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)
  • 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)

Abstract

L'invention concerne un dispositif orthétique destiné à entourer et à supporter une partie du corps (par exemple, une articulation) d'un être humain ou d'un animal. Le dispositif orthétique est une feuille unique d'un matériau à base d'acide polylactique (PLA) moulable configurée pour maintenir la partie du corps dans une position optimale pour le développement et le traitement. Un système orthétique comprend la feuille de PLA et une couche de protection sous la forme d'une seule feuille moulable de mousse de polyéthylène (PEF). La feuille de PEF est conçue pour être placée entre la feuille de PLA et la partie du corps.
EP19779088.4A 2018-07-04 2019-07-02 Dispositif orthétique, système orthétique et leurs procédés de fabrication et d'utilisation Withdrawn EP3817700A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862693971P 2018-07-04 2018-07-04
PCT/IB2019/000676 WO2020008253A1 (fr) 2018-07-04 2019-07-02 Dispositif orthétique, système orthétique et leurs procédés de fabrication et d'utilisation

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EP3817700A1 true EP3817700A1 (fr) 2021-05-12

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EP (1) EP3817700A1 (fr)

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