WO2014116887A1 - Plâtres orthopédiques et leurs procédés de fabrication - Google Patents

Plâtres orthopédiques et leurs procédés de fabrication Download PDF

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Publication number
WO2014116887A1
WO2014116887A1 PCT/US2014/012839 US2014012839W WO2014116887A1 WO 2014116887 A1 WO2014116887 A1 WO 2014116887A1 US 2014012839 W US2014012839 W US 2014012839W WO 2014116887 A1 WO2014116887 A1 WO 2014116887A1
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WO
WIPO (PCT)
Prior art keywords
cast
occlusive
conduits
combination
fixtures
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Application number
PCT/US2014/012839
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English (en)
Inventor
Paul Douglas PATERSON
Original Assignee
Paterson Paul Douglas
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 Paterson Paul Douglas filed Critical Paterson Paul Douglas
Publication of WO2014116887A1 publication Critical patent/WO2014116887A1/fr

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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

Definitions

  • the present invention relates generally to casts and features thereof.
  • the present invention encompasses orthopaedic casts, orthopaedic cast components, and methods for making and using such casts to allow, facilitate, enhance, and/or improve the healing process associated with cast immobilization.
  • the present invention provides a cast including a casting composition with at least one layer of reticulated material configured to conform to a body surface that defines a casting region, where the casting region is substantially enveloped by the casting composition to form an orthopaedic cast having one or more fenestrations, one or more conduits embedded in the one or more fenestrations, one or more occlusive fixtures capable of cooperatively interacting with the one or more conduits when the one or more occlusive fixtures are substantially aligned with the one or more conduits, and one or more distractors composed of a distractor body, distractor tip and a distractor end, where the one or more distractors are configured to reversibly engaged the one or more occlusive fixtures in an engaged configuration, and where the one or more distractors are configured to reversibly disengaged the one or more occlusive fixtures in a disengaged configuration.
  • the cast further includes a securing mechanism to reversibly connect the one or more distractors to the one or more occlusive fixtures, and/or to reversibly connect the one or more occlusive fixtures to the one or more conduits.
  • the one or more occlusive fixtures extend beyond the plane of the one or more conduits and/or fenestrations. In other embodiments, the one or more occlusive fixtures are flush with the plane of the one or more conduits and/or fenestrations.
  • the reticulated material is selected from silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM, or any combination thereof.
  • Suitable embodiments of the present invention include a body surface selected from an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the casting region allows for application of the cast to an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the cast is selected from a spica cast and a thoracolumbar cast.
  • the one or more fenestrations have a shape in some embodiments selected from circular, rectangular, square, polygonal, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the one or more fenestrations are positioned within the orthopaedic cast in a manner selected from the group consisting of angled, straight, slanted, tapered, orthogonal, parallel, perpendicular, curved, diagonal, random, or any combination thereof.
  • the one or more fenestrations provide for ventilation, moisture release, liquid drainage, wound access, wound healing, or drying, or any combination thereof, in illustrative embodiments.
  • the one or more fenestrations in some embodiments, allow for treatment, medicament application, injections, delivery of intravenous fluids, topical cream application, application of ointments, cold compresses application, application of ice, coolant application, or for applying heat, or any combination thereof.
  • the one or more fenestrations provide for decreased odor relative to the orthopaedic cast in the absence of the one or more fenestrations.
  • the one or more conduits have a lower surface and a side surface, where the side surface defines an inner space for engaging the one or more occlusive fixtures, and where the lower surface is positioned adjacent to the body surface.
  • the lower surface has a lower inferior surface possessing one or more adherence nodes, one or more cylindania, or both.
  • the one or more conduits have an exterior surface defining a region contacting the casting composition.
  • the height of the one or more conduits is from about 0.01 cm to about 10 cm.
  • the one or more conduits are composed of silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • the one or more conduits allow for ventilation, moisture release, liquid drainage, wound access, wound healing, or drying, or any combination thereof.
  • the or more conduits comprises one or more vents, one or more channels, or both.
  • the vents and/or channels are position throughout the lower surface of the conduit, the side surface of the conduit, or both.
  • the vents and/or channels provide for aromatic dissemination, heating applications to allow for hardening of the casting material, or both.
  • the one or more conduits allow for application of treatment, medicaments, injections, intravenous fluids, topical creams, ointments, cold compresses, ice, coolants, or heat, or any combination thereof.
  • the one or more conduits allow for decreased odor relative to the orthopaedic cast in the absence of the one or more conduits.
  • the one or more conduits are one or more orthopaedic cast grommets.
  • the one or more conduits are configured as one or more silicone bridges.
  • the one or more occlusive fixtures as provided herein are selected from plugs, screws, caps, covers, seals, rivets, corks, and stoppers, or any combination thereof.
  • the one or more occlusive fixtures are composed of silicone, rubber, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • the one or more occlusive fixtures have a shape selected from polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the one or more occlusive fixtures interact with the one or more conduits in a manner selected from the group consisting of angled, straight, slanted, tapered, orthogonal, polygonal, curved, diagonal, random, or any combination thereof.
  • the or more occlusive fixtures are removable or interchangeable, or both.
  • the one or more occlusive fixtures have a surface, and wherein the surface is decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • the one or more occlusive fixtures further comprise a repository, where the repository is a liquid repository, which can be a fragrance repository.
  • the repository is a liquid repository, which can be a fragrance repository.
  • one or both of the distractor end and distractor tip are in a substantially orthogonal position to an axis of the one or more occlusive fixtures when the one or more distractors are in the disengaged configuration.
  • one or both of the distractor end and the distractor tip are in a substantially parallel position to an axis of the one or more occlusive fixtures when the one or more distractors are in the engaged configuration.
  • the height of the one or more distractors is from about 0.01 cm to about 10 cm.
  • the one or more distractors are composed of silicone, rubber, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • the one or more distractors have a shape selected from the group consisting of angled, straight, slanted, tapered, curved, diagonal, random, polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • one or both of the distractor end and the distractor tip have a shape selected from the group consisting of angled, straight, slanted, tapered, curved, diagonal, random, polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • one or more distractors have a surface or design, where the surface or design is decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • the cooperative interaction is selected from one or more snapping components, screws, rivets, clamps, adhesives, locks, friction fitting, or any combination thereof.
  • the reversible engagement is selected from the group consisting of one or more snapping components, screws, clamps, adhesives, locks, rivets, friction fitting, or any combination thereof.
  • the securing mechanism is selected from the group consisting of one or more snapping components, screws, rivets, clamps, adhesives, locks, friction fitting, or any combination thereof.
  • the present invention provides for a device including a conduit having a lower surface and a side surface, where the side surface defines an inner space, and where the lower surface is positioned adjacent to a body surface, an occlusive fixture capable of cooperatively interacting with the conduit when the occlusive fixture is substantially aligned with the conduit, and securing mechanism that reversibly connects to the occlusive fixture, and/or reversibly connects the occlusive fixture to the conduit.
  • the device further includes a distractor having a distractor tip, distractor body, and a distractor end, where the distractor is configured to reversibly engaged the occlusive fixture in an engaged configuration, and where the distractor is configured to reversibly disengaged the occlusive fixture in a disengaged configuration.
  • the conduit is embedded in an orthopaedic cast fenestration.
  • the occlusive fixture extends beyond the plane of the orthopaedic cast conduit and/or fenestration. In other embodiments, the occlusive fixture is flush with the plane of the orthopaedic cast conduit and/or fenestration.
  • the device further includes an orthopaedic cast having one or more fenestrations.
  • the orthopaedic cast having one or more fenestrations includes a casting composition with at least one layer of reticulated material configured to conform to the body surface, where the body surface defines a casting region, and where the casting region is substantially enveloped by the casting composition to form the orthopaedic cast having one or more fenestrations.
  • the lower surface has a lower inferior surface possessing one or more adherence nodes, one or more cylindania, or both.
  • the conduit has an exterior surface, where the exterior surface defines a region contacting the casting composition.
  • the height of the conduit is from about 0.01 cm to about 10 cm and the conduit is composed of silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof, in some embodiments.
  • the conduit allows for ventilation, moisture release, liquid drainage, wound access, wound healing, or drying, or any combination thereof.
  • the one or more conduits comprises one or more vents, one or more channels, or both.
  • the vents and/or channels are position throughout the lower surface of the conduit, the side surface of the conduit, or both.
  • the vents and/or channels provide for aromatic dissemination, heating applications to allow for hardening of the casting material, or both.
  • the conduits of the present invention allows for application of treatment, medicaments, injections, intravenous fluids, topical creams, ointments, cold compresses, ice, coolants, or heat, or any combination thereof.
  • the one or more conduits are configured as one or more silicone bridges.
  • the conduit allows for decreased odor relative to an orthopaedic cast in the absence of the conduit.
  • the occlusive fixture is selected from one or more snapping components, screws, clamps, adhesives, locks, rivets, friction fitting components, or any combination thereof.
  • the occlusive fixture has a shape selected from the group consisting of polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the occlusive fixture interacts with the conduit in a manner selected from the group consisting of angled, straight, slanted, tapered, orthogonal, polygonal, curved, diagonal, random, or combinations thereof.
  • the occlusive fixture is removable or interchangeable, or both.
  • the occlusive fixture has a surface, wherein the surface is decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • the occlusive fixture further has a repository, where the repository is a liquid repository in some embodiments.
  • the repository is a fragrance repository.
  • a securing mechanism selected from one or more snapping components, screws, rivets, clamps, adhesives, locks, friction fitting components, or any combination thereof.
  • the present invention provides a method of making a cast, which includes providing a casting composition composed of at least one layer of reticulated material configured to conform to a body surface that defines a casting region, placing one or more conduits on the casting region surface, encasing the casting region with the one or more conduits on the casting region surface to form an orthopaedic cast having the one or more conduits embedded in the orthopaedic cast, and providing one or more occlusive fixtures capable of cooperatively interacting with the one or more conduits when the one or more occlusive fixtures are substantially aligned with the one or more conduits.
  • the method further includes providing one or more distractors comprising a distractor body, distractor tip and distractor end, where the one or more distractors are configured to reversibly engaged the one or more occlusive fixtures in an engaged configuration, and where the one or more distractors are configured to reversibly disengaged the one or more occlusive fixtures in a disengaged configuration.
  • the methods further include securing the one or more occlusive fixtures to the one or more conduits such that the one or more occlusive fixtures and the one or more conduits interact and remain connected when the one or more occlusive fixtures is in the substantially aligned position with the one or more conduits.
  • the method further includes securing the one or more distractors to the one or more occlusive fixtures such that the one or more occlusive fixtures and the one or more distractors interact and remain connected when engaged.
  • the reticulated material is selected from silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic-based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • the casting composition further includes silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • the body surface is selected from the an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the casting region allows for application of the cast to an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the one or more conduits have a lower surface and a side surface, where the side surface defines an inner space for engaging the one or more occlusive fixtures, and where the lower interior surface is positioned adjacent to the body surface.
  • the lower surface has a lower inferior surface possessing one or more adherence nodes, one or more cylindania, or both.
  • the one or more conduits have an exterior surface, where the exterior surface defines a region contacting the casting composition.
  • the height of the one or more conduits is from about 0.01 cm to about 10 cm.
  • the one or more conduits are composed of silicone, fiberglass, metal, ceramic, one or more polymers, rubber, resin, plaster, plastic, scented plastic, cellulose, or scented cellulose, or any combination thereof.
  • the one or more conduits allow for ventilation, moisture release, liquid drainage, wound access, wound healing, or drying, or any combination thereof.
  • the one or more conduits comprises one or more vents, one or more channels, or both.
  • the vents and/or channels are position throughout the lower surface of the conduit, the side surface of the conduit, or both.
  • the vents and/or channels provide for aromatic dissemination, heating applications to allow for hardening of the casting material, or both.
  • the one or more conduits allow for application of treatment, medicaments, injections, intravenous fluids, topical creams, ointments, cold compresses, ice, coolants, or heat, or any combination thereof.
  • the one or more conduits allow for decreased odor relative to the orthopaedic cast in the absence of the one or more conduits.
  • the one or more conduits are configured as one or more silicone bridges.
  • the one or more conduits are one or more orthopaedic cast grommets.
  • the one or more occlusive fixtures are selected from the group consisting of plugs, screws, rivets, caps, covers, seals, corks, and stoppers, or any combination thereof.
  • the one or more occlusive fixtures have a shape selected from the group consisting of polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the one or more occlusive fixtures interact with the one or more conduits in a manner selected from the group consisting of angled, straight, slanted, tapered, orthogonal, polygonal, curved, diagonal, random, or any combination thereof.
  • the one or more occlusive fixtures are removable or interchangeable, or both.
  • the one or more occlusive fixtures have a surface, wherein the surface is decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • the one or more occlusive fixtures further comprise a repository.
  • the repository is a liquid repository.
  • the repository is a fragrance repository.
  • the securing is snapping, screwing, clamping, adhering, locking, riveting, fitting or any combination thereof.
  • FIG. 1 is a perspective view of an orthopaedic cast of the present invention.
  • FIG. 2 is a cross-sectional view of an orthopaedic cast of the present invention.
  • FIG. 3 is a perspective view of an orthopaedic cast conduit with vents.
  • FIG. 4 is a perspective view of an orthopaedic cast conduit with channels.
  • FIG. 5 is a top view of an orthopaedic cast conduit of the present invention.
  • FIG. 6 is a cross-sectional view of an orthopaedic cast conduit.
  • FIG. 7 is a top view of a cast conduit, an occlusive fixture and distractor.
  • FIG. 8 is a cross-sectional view of a cast conduit, occlusive fixture, and distractor.
  • FIG. 9 is a cross-sectional view of an orthopaedic cast conduit, occlusive fixture, and distractor rotated 90°.
  • FIG. 10 is a side view of a cast conduit, occlusive fixture, and distractor.
  • FIG. 1 1 is a perspective view of an orthopaedic cast occlusive fixture.
  • FIG. 12 is a side/bottom view of an orthopaedic cast occlusive fixture.
  • FIG. 13 shows a diagrammatic flow chart of an illustrative embodiment of the process for making an orthopaedic cast of the present disclosure.
  • FIG. 14 shows a representative embodiment of a conduit with channels of the present invention.
  • body surface or “casting region,” refer to a part or structure of the body, having a certain function or functions, which can provide an area for cast immobilization, and includes, but is not limited to, an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the "casting region" allows for application of the cast to an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the terms “cast”, “casting”, “casting materials”, “orthopaedic cast”, and/or “orthopedic cast” used in the context of preparation, production, and/or methods of making an immobilization substrate suitable for immobilizing a particular region or regions of an individual's anatomy refer to any surface or structure created that is capable of immobilizing a body surface or region and any ancillary regions coterminous therewith.
  • Such casts have various contemplated surfaces, and/or are composed of materials, which include, but are not limited to, silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM, stocking materials, padding, stockinettes, biocompatible or biodegradable polymers, copolymers, and the like.
  • materials include, but are not limited to, silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM, stocking materials, padding, stockinettes, biocompatible or biodegradable polymers, copolymers, and the like.
  • the terms "comparable” or “corresponding” in the context of comparing two or more outcomes, responses, or conditions refer to the same individual, cast, response, treatment, etc. used in the comparison.
  • the odor associated with wearing a cast can be compared to the odor (or absence thereof) associated with wearing a different cast or having a different cast embodiment.
  • comparable features may be obtained from the same individual at different times.
  • comparable samples may be obtained from different individuals.
  • comparable variables are normalized by a common factor for control purposes.
  • composition refers to a product with specified ingredients in the specified amounts, as well as any product which results, directly or indirectly, from combination of the specified ingredients in the specified amounts.
  • cooperatively interact or "cooperatively interacting” refer to the association of two or more adjoining components, where each component functions to facilitate the association. For example, a fitted plug would cooperatively interact with the component that the plug was fabricated to fit.
  • the term "distractor” refers to an element composed of, but not limited to, a distractor tip, distractor body, and a distractor end, where the distractors interact, connect, engage, lock, secure, rivet and/or disconnect, disengage, unlock, and/or remove from, for example, an occlusive fixtures of the present invention. Such interaction typically occurs through the distractor body and/or distractor tip in illustrative
  • Distractor tips provided herein are configured to accesses a port, portal, region, or complementary fitting, provided in an occlusive fixture in some embodiments.
  • the distractor tips, body, and/or end are positioned in an occlusive fixture in a manner selected from angled, straight, slanted, tapered, curved, diagonal, random, polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof, capable of reversibly interacting, engaging, connecting, locking, and/or securing to the occlusive fixture access port or ports in suitable embodiments.
  • the distractors may be configured as, e.g., hollow or solid rods, poles, members, tubes, plugs, screws, caps, rivets, covers, keys, wrenches, gripping members, and the like, or any combination thereof.
  • the terms “engage”, “reversible engage”, “reversibly engaged”, and “engaged configuration” all refer to the act or state of being associated or connected in a secure manner for the purpose of joining two or more components for a period of time. For example, two components are engaged with each other when they are in contact and securely connected or associated for a period of time. To be in the engaged state, the components are in contact while concomitantly occupying an engaged state, such as, for example, a locked state. If such components are "reversibly engaged” then the components can be engaged and disengaged with respect to the features enabling such association and disassociation, respectively.
  • occlusive fixture refers to, e.g., plugs, screws, caps, covers, seals, corks, and stoppers, or any combination thereof, such that the occlusive fixture substantially covers the region or area intended to be covered, e.g., the open space of a conduit of the present invention.
  • occlusive fixture shapes and sizes are provided herein, and include, but are not limited to, for example, shapes such as, e.g., polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • a reference level refers to a level or measurement of a substance or variable which may be of interest for comparative purposes.
  • a reference level may be a specified moisture content as an average of the moisture content taken from a control subject.
  • the reference level may be the level in the same subject at a different time, e.g., a time course of administering a particular casting composition.
  • reticulated material refers to compositions or composition matrices composed of network constituents forming one or more layers or matrix configurations.
  • reticulated material include, but are not limited to, fiberglass, silicone, one or more polymers, plastic, resin, plaster, stocking material, and padding, or any combination thereof. Examples of casting polymers are known in the art.
  • the terms "subject” or “individual” refer to a mammal, such as a human, but can also be another animal such as a domestic animal, e.g., a dog, cat, or the like, a farm animal, e.g., a cow, a sheep, a pig, a horse, or the like, or a laboratory animal, e.g., a monkey, a rat, a mouse, a rabbit, a guinea pig, or the like.
  • patient refers to a "subject” who is, or is suspected to be, suffering from a bone fracture or break.
  • the terms "substantial” or “substantially” within the context of a "substantially enveloped” surface or region or a “substantially aligned” configuration refer to, e.g., total or complete envelopment or alignment, and the like, but also includes lesser than complete or total envelopment or alignment, and the like, insofar as the intended purpose for performing the act can be carried out to the same extent as if the, e.g., envelopment or alignment, were total or complete.
  • the terms “treating” or “treatment” or “alleviation” refer to both therapeutic treatment and prophylactic or preventative measures, where the objective is to prevent or slow down (lessen) the targeted injury, condition or disorder.
  • a subject is successfully “treated” for a disorder if, after receiving therapeutic intervention according to the methods of the present invention, the subject shows observable and/or measurable reduction in or absence of one or more signs and symptoms of a particular injury/condition.
  • the present invention relates to, inter alia, novel orthopaedic casts, orthopaedic cast components, and methods for making and using such casts to allow, facilitate, enhance, and/or improve the healing process and an individual's experience associated with cast immobilization. Such aspects of the present invention consequently provide for increased compliance and comfort while wearing a cast.
  • orthopaedic casts are also employed by medical practitioners for, but not limited to, musculoskeletal conditions and osteodegeneration.
  • flexible splints which are non-circumferential immobilizers that accommodate swelling and inflammation
  • orthopaedic casts are ridged circumferential applications capable of immobilizing any region of the body.
  • Such casts can be associated with complications stemming from the lack of flexibility and are therefore reserved for complex and/or definitive bone fracture management.
  • excessive immobilization can lead to chronic pain, joint stiffness, muscle atrophy, or more severe complications, e.g., complex regional pain syndrome.
  • Serious bone fractures such as, e.g., compound fractures, may be accompanied by an associated wound or injury (e.g., lacerated tissues or organs, infection, severe inflammation, and the like).
  • wound or injury e.g., lacerated tissues or organs, infection, severe inflammation, and the like.
  • proper wound healing may necessitate therapeutic intervention requiring access to an injury site, which in many instances cannot be adequately achieved by conventional casts.
  • the present invention provides for such access, as further detailed below, thereby allowing for therapeutic applications, liquid drainage, proper ventilation, moisture release, wound access, drying, medicament application, injections, delivery of intravenous fluids, topical cream application, application of ointments, cold compresses application, applying ice or other coolants, or for applying heat, electromagnetic treatment, or any combination thereof.
  • Current casting methods and procedures for gaining access to an injury site are disruptive and require the formation of an injury access portal by punching or cutting through cast layers. See, e.g., US 2011/0301518. Such techniques are not only dangerous when performed on an applied cast, but may also compromise the structural integrity of the cast.
  • the present invention remedies the deficiencies described above by providing novel orthopaedic casts, orthopaedic cast components, and methods for making and using such casts to ensure proper bone healing via non-disruptive cast applications which comport with a patient's aesthetic preferences, as described herein.
  • the present invention provides a cast including a casting composition with at least one layer of reticulated material configured to conform to a body surface that defines a casting region, where the casting region is substantially enveloped by the casting composition to form an orthopaedic cast having one or more fenestrations, one or more conduits embedded in the one or more fenestrations, one or more occlusive fixtures capable of cooperatively interacting with the one or more conduits when the one or more occlusive fixtures are substantially aligned with the one or more conduits, and one or more distractors composed of a distractor tip and a distractor end, where the one or more distractors are configured to reversibly engaged the one or more occlusive fixtures in an engaged configuration, and where the one or more distractors are configured to reversibly disengaged the one or more occlusive fixtures in a disengaged configuration.
  • the orthopaedic casts of the present invention further include, in illustrative embodiments, a securing mechanism to reversibly connect a distractor to an occlusive fixture in conjunction with, or in the alternative, connecting an occlusive fixture to a conduit, or both.
  • the one or more occlusive fixtures and/or the distractors are modified or designed to retain functionality while importing decorative and/or ornamental configurations which comport with a patient's aesthetic preference.
  • orthopaedic casts which include casting compositions with at least one layer of reticulated material configured to conform to a body surface that defines a casting region.
  • reticulated materials include, but are not limited to, for example, silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM, or any combination thereof.
  • the body surface is an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the casting region allows for application of the cast to an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • padding and/or stockinette application occurs followed by circumferential application of from about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, to about from 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 layers of cotton padding or stockinette material.
  • circumferential application of casting materials or composition e.g., plaster or fiber-glass, and the like, are added.
  • about 2-inch padding is used for hand applications and from about 2- to 6-inch padding for upper extremities, where about 3 -inch padding and from about 4- to 6-inch padding are employed for foot and lower extremities applications, respectively.
  • upper extremity casts include, without limitation, e.g., ulnar gutter casts, which are commonly used for definitive or alternative treatment of injuries typically treated with less restrictive remediation, e.g., an ulnar gutter splint.
  • An ulnar gutter cast in some embodiments, is applied to a body region from about 14 to 60 hours after the initial injury, where the casting materials are wrapped circumferentially.
  • Radial gutter casts moreover, are employed for definitive or alternative treatment of injuries commonly treated with less immobilization, e.g., a radial gutter splint. The cast is usually placed 2 to 8 days after the initial injury to allow for swelling resolution.
  • spica thumb casts can be employed for suspected or non-displaced, distal fractures of the scaphoid, and/or non-angulated, non-displaced, and/or extra-articular fractures of the base of the first metacarpal.
  • Short arm casts are beneficial for treating non-displaced or minimally displaced fractures of the distal wrist, such as colles and smith fractures or greenstick, buckle, and physeal fractures in children, and/or carpal bone fractures other than the scaphoid or trapezium.
  • Such casts may extend from the proximal one third of the forearm to the distal palmar crease volarly and proximal to the dorsal metacarpophalangeal (MCP) joints.
  • MCP dorsal metacarpophalangeal
  • the wrist Prior to such cast applications, the wrist is placed in a neutral position with slight extension and freely mobile MCP joints.
  • long arm cast indications include, for example, definitive treatment of injuries that are typically first treated with a posterior splint.
  • Such casts generally extend from the mid-humerus to the distal palmar crease volarly and just proximal to the MCP joints dorsally. In these circumstances, the elbow is flexed to about 90° with the wrist in a neutral, but slightly extended position. Adequate padding at the olecranon, ulnar styloid, and antecubital fossa, furthermore, may be required to curtail skin decomposition. Long arm casts are most often seen in childhood or adolescent patients because of the frequency of distal radial, ulnar, and distal humeral fractures. See, e.g., Overly and Steele, "Common pediatric fractures and dislocations.” Clin Pediatr Emerg Med.
  • short leg casts indications include definitive treatment of injuries to the ankle and foot. Such casts generally begin at the metatarsal heads and ends approximately two inches distal to the fibular head. Additional padding can be placed over bony prominences, including the fibular head and both malleoli.
  • the ankle is typically flexed to a neutral 90°. Weight-bearing recommendations are typically determined by the type and stability of the injury and a patient's capacity for discomfort. Short leg walking casts may be adequate for non-displaced fibular and metatarsal fractures. Toe plate extensions provide for toe immobilization, is required.
  • the plate can be made by extending the casting material beyond the distal toes, prohibiting plantar flexion and limiting dorsiflexion See, e.g., Eiff et ah, eds, Fracture Management for Primary Care. 2nd ed. Philadelphia, Pa.: Saunders; 1-70 (2003).
  • the casts of the present invention are selected from a spica cast or a thoracolumbar cast, or both in suitable embodiments.
  • Orthopaedic casts disclosed herein further include features such as, e.g., fenestrations, apertures, channels, holes, passages, and the like, which allow for a variety of applications as described below.
  • such applications include, but are not limited to, embedding one or more conduits, channels, members, rods, and the like, in and/or within an orthopaedic cast.
  • the fenestrations and/or conduits provide for, in illustrative embodiments, air flow and circulation, heating and/or cooling applications allowing for cast solidification or hardening, aromatic dissemination throughout the casting region and body surface, application of various treatments, therapies, and modifications of or to the injury site and cast, respectively.
  • one or more conduits are embedded within an orthopaedic cast of the present invention.
  • the cast of the present invention provides for one or more fenestrations having shapes selected from circular, rectangular, square, polygonal, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the design can be any shape insofar as the design provides for conduit placement, insertion, or for a cast to be generated or positioned during patient application such that the fenestrations are assumed by the one or more conduits.
  • the one or more fenestrations and/or conduits are positioned within the orthopaedic cast in a manner selected from angled, straight, slanted, tapered, orthogonal, parallel, perpendicular, curved, diagonal, random, or any combination thereof.
  • Such conduits and fenestrations impart ventilation, moisture release, liquid drainage, wound access, wound healing, or drying, or any combination thereof, in illustrative embodiments.
  • conduits and fenestrations allow for treatment, medicament application, injections, delivery of intravenous fluids, topical cream application, application of ointments, cold compresses application, application of ice, coolant application, for applying heat, electostimulatory therapy, and/or any combination thereof.
  • the one or more conduits and/or fenestrations provide for decreased odor associated with cast immobilization relative to orthopaedic casts that do not include such features, as further detailed below.
  • the present invention provides for a device including a conduit having a lower surface and a side surface, where the side surface defines an inner space, and where the lower surface is positioned adjacent to a body surface, an occlusive fixture capable of cooperatively interacting with the conduit when the occlusive fixture is substantially aligned with the conduit, and a securing mechanism to reversibly connect the occlusive fixture and the conduit, and/or to reversibly connect the distractors of the present invention to the occlusive fixtures.
  • the distractors have a distractor tip and a distractor end, where the distractor is configured to reversibly engaged the occlusive fixture in an engaged configuration, and where the distractor is configured to reversibly disengaged the occlusive fixture in a disengaged configuration.
  • the distractor imparts the securing mechanism of the present invention.
  • conduits, members, rods, tubes, and other passage applications which are embedded in one or more, e.g., fenestrations, apertures, holes, passages, and the like, are also provided herein.
  • the conduits include in suitable embodiments, e.g., vents, channels, holes, perforations, openings, and the like. Consequently, the conduits enable air flow and circulation, heating and/or cooling applications allowing for cast solidification or hardening, aromatic dissemination throughout the casting region and body surface, application of various treatments, therapies, and modifications of or to the injury site and cast, respectively, in illustrative embodiments.
  • the conduits may be composed of silicone, fiberglass, metal, ceramic, one or more polymers, rubber, resin, plaster, plastic, scented plastic, cellulose, or scented cellulose, scented polymers, or any combination thereof, in some embodiments.
  • Scented materials such as, e.g., scented plastic, scented polymers and scented cellulose, are materials that are currently available for use in casting applications in suitable embodiments.
  • AuracellTM provides scented polymer (cellulose) applications, including, but not limited to, the scented polymer applications listed below in Table 1 , which are suitable for use in various embodiments of the resent invention.
  • the one or more conduits provide for ventilation, moisture release, liquid drainage, wound access, wound healing, treatment or drying, or any combination thereof, in various embodiments of the present invention.
  • the or more conduits comprises one or more vents, half-cylinder "cylindania" and/or channels, which, in some embodiments, are position throughout the lower surface of the conduit, the side interior surface of the conduit, or both. See id.
  • vents, cylindania and channels provide for aromatic dissemination within or around the casting region, heating applications to allow for cast material solidification, or both, among other applications.
  • the one or more conduits allow for application of treatment, medicaments, injections, intravenous fluids, topical creams, ointments, cold compresses, ice, coolants, or heat, or any combination thereof.
  • the vents, cylindania and/or channels can be of any shape or size to the extent that such shapes and sizes provide for the intended purpose, as described herein.
  • the shape of the vents, cylindania and/or channels are selected from conical, frusto-conical, rounded, flat, pointed, burred, bubble-shaped, dome-shaped, cylindrical, half-cylinder, tubed, circular, peri-circular, rectangular, square, polygonal, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof. See FIG. 14 as an illustrative example.
  • the cylindania While the channels and/or vents are typically positioned on the side surface of the conduit, the cylindania are borne out of the inferior region of the conduit lower surface, which imparts a means of increased air circulation and the fluid flow of fragrances, scents, and the like.
  • the cylindania have shapes selected from cylindrical, half-cylinder, tubed, peri-circular, rectangular, square, polygonal, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • Conduits of the present invention further include adherence nodes protruding from the inferior region of the lower conduit surface. Such nodes directly contact a body surface while at least functioning to secure, anchor, position and/or adhere the conduit to the surface being treated.
  • the nodes have shapes selected from conical, frusto-conical, rounded, flat, pointed, burred, bubble-shaped, dome-shaped, circular, rectangular, square, polygonal, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the adherence nodes can be of any shape or size to the extent that they provide for the intended purpose, as described. See, e.g., FIG. 14.
  • suitable embodiments of the present invention include conduits that provide for decreased odor associated with orthopaedic cast applications compared to odor associated with an individual wearing an orthopaedic cast in the absence of the one or more conduits.
  • conduit vent holes and/or channels are positioned within the side surface or side wall of the conduit in some embodiments, which function by increasing air flow and aromatic dissemination as described above, and allow for heating applications that may be required for cast solidification, among other applications.
  • the one or more conduits are one or more orthopaedic cast grommets, which can be configured and/or manufactured as silicone bridges.
  • the one or more conduits have a side surface, where the external side surface defines a region contacting the casting composition. See FIG. 2.
  • the height of the conduit is from about 0.001, 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, or 5 cm to about from 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25 or 30 cm, in some embodiments.
  • Other embodiments include a conduit height from about 0.1, 0.5, 0.75, or 1 cm to about from 0.5, 0.75, 1, 2, or 3 cm.
  • the height of the one or more conduits is from about 0.01 cm to about 10 cm, while in illustrative embodiments, the height of the one or more conduits is from about 0.5 cm to about 3 cm.
  • the full diameter, i.e., measured from the edge of the lower surface, of the conduit in some embodiments, is from about 0.001, 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, or 5 cm to about from 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25 or 30 cm.
  • Other embodiments include a conduit full diameter from about 0.1, 0.5, 0.75, or 1 cm to about from 0.5, 0.75, 1, 5, or 10 cm.
  • the full diameter of the one or more conduits is from about 1 cm to about 10 cm, while in illustrative embodiments, the full diameter of the one or more conduits is from about 4 cm to about 6 cm.
  • the inner diameter, i.e., measured from the edge of the side surface, of the conduit is from about 0.001, 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, or 5 cm to about from 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25 or 30 cm, in some embodiments.
  • Other embodiments include a conduit inner diameter from about 0.1, 0.5, 0.75, or 1 cm to about from 0.5, 0.75, 1, 5, or 10 cm.
  • the full diameter of the one or more conduits is from about 1 cm to about 10 cm, while in illustrative embodiments, the full diameter of the one or more conduits is from about 3 cm to about 5 cm.
  • the present invention provides one or more occlusive fixtures, which are configured and/or manufactured as silicone bridges in suitable embodiments.
  • the occlusive fixtures of the present invention interact, connect, engage, and/or disconnect, disengage, and/or remove from the conduits as described herein.
  • the occlusive fixtures are, e.g., plugs, screws, caps, covers, seals, corks, and stoppers, or any combination thereof.
  • the occlusive fixtures may be composed of silicone, rubber, adhesive, foam, TPE, vinyl, non- water hardenable urethane, plastic materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof.
  • occlusive fixture shapes and sizes are provided in suitable
  • occlusive fixtures include, but are not limited to, for example, shapes such as, e.g., polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof, such that the occlusive fixtures are capable of cooperatively interacting, interacting, engaging, and/or connecting to or covering the open region of a conduit.
  • shapes such as, e.g., polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof, such that the occlusive fixtures are capable of cooperatively interacting, interacting, engaging, and/or connecting to or covering the open region of a conduit.
  • the one or more occlusive fixtures interact with the one or more conduits in a manner selected from angled, straight, slanted, tapered, orthogonal, polygonal, curved, diagonal, random, or any combination thereof. Such interaction may occur via plugging, screwing, capping, covering, sealing, corking, locking, riveting, and/or stopping, or any combination thereof.
  • the or more occlusive fixtures are removable or interchangeable, or both.
  • the surface of the occlusive fixtures can be decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • the surface of an occlusive fixture and/or the entire occlusive fixture is fabricated or designed as a decorative element or feature in some embodiments. Alternatively, decorative features can be attached to the surface of the occlusive fixture in certain embodiments.
  • the decorative embodiments and/or features are selected from charms, accessories, entertainment applications, aesthetic components, jewelry, stickers, adhesives, decals, ornaments, styling elements, watch features, watches, calculators, mobile phone accessories, computer and electronic application accessories, holders, make-up and beauty applications, learning and/or educational applications, sports and trading card applications, and the like in some embodiments, all of which are interchnagable and accessible to an individual wearing the orthopaedic cast of the present invention.
  • the one or more occlusive fixtures further comprise a repository.
  • a repository is a liquid repository and/or a fragrance repository in illustrative embodiments. Any fragrance or fragrance combination known in the art can be employed to this end for use in the present invention, and the skilled artisan will recognize that such fragrances may be used alone or in conjunction with scented materials, such as, e.g., those provided via AuracellTM (scented plastic).
  • Distractors of the present invention constitute a distractor tip, distractor body, and a distractor end, where the distractors interact, connect, engage, lock, secure, rivet and/or disconnect, disengage, unlock, and remove from the occlusive fixtures via the distractor body and/or tip in illustrative embodiments.
  • the distractor tips are configured to accesses a port, portal, region, or complementary fitting provided in the occlusive fixture in some embodiments.
  • the distractor tips and/or body are positioned in an occlusive fixture in a manner selected from angled, straight, slanted, tapered, curved, diagonal, random, polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof capable of reversibly interacting, engaging, connecting, locking, and/or securing to the occlusive fixture access port or portals in suitable embodiments.
  • Such positioning secures the distractor to the occlusive fixture via a plugging, screwing, capping, covering, sealing, corking, locking, riveting, and/or stopping mechanism, or any combination thereof.
  • a distractor is removable or interchangeable, or both.
  • the distractors may be configured as, e.g., hollow or solid rods, poles, members, tubes, plugs, screws, caps, rivets, covers, keys, wrenches, gripping members, and the like, or any combination thereof.
  • the distractors are composed of silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic -based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof, in suitable embodiments.
  • Various shapes and sizes of the distractors are provided, and include, but are not limited to, for example, shapes such as, e.g., polygonal, rectangular, square, circular, curved, concentric, concave, perimetric, diamond, hexagonal, or triangular configurations, or any combination thereof.
  • the entire distractor but more specifically in some embodiments, the distractor end is decorated, colored, patterned, texturized, colorimetric, modifiable, or designable, or any combination thereof.
  • the distractor end and/or the entire distractor is fabricated or designed at the outset as a decorative or ornamental element or feature in some embodiments. Alternatively, decorative or ornamental features can be attached to the distractor end in certain embodiments.
  • the decorative or ornamental embodiments and/or features relating to the distractor ends of the present invention encompass charms, accessories, entertainment applications, aesthetic components, jewelry, stickers, adhesives, decals, ornaments, styling elements, watch features, watches, calculators, mobile phone accessories, computer and electronic application accessories, holders, make-up and beauty applications, learning and/or educational applications, sports or trading card applications, and the like in some embodiments, all of which are interchnagable and accessible to an individual wearing the orthopaedic cast of the present invention.
  • the height and/or width of the one or more distractors (as a whole or each constituent thereof, individually) is from about 0.001, 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, or 5 cm to about from 0.01, 0.1, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25 or 30 cm. More specifically, some embodiments of the present invention provide for distractors having a height and/or width from about 0.1, 0.5, 0.75, or 1 cm to about from 0.5, 0.75, 1, 2, or 3 cm. In suitable embodiments, the height and/or width of the one or more distractors is from about 0.01 cm to about 10 cm, while in illustrative embodiments, the height of the one or more distractors is from about 2 cm to about 4 cm.
  • the distractor tip in some embodiments is substantially parallel to an axis of the one or more occlusive fixtures when the distractor is in an engaged configuration. In contrast, the distractor tip is in a substantially orthogonal position to an axis of the one or more occlusive fixtures when the one or more distractors are in the disengaged configuration.
  • Other embodiments of the present invention provide for distractor engagement, reversibly or permanently, with the occlusive fixture via cooperative interaction, such as, for example, screwing, clamping, adhering, locking, riveting, friction fitting, or any combination thereof.
  • the cooperative interaction, reversible engagement, and/or securing is selected from snapping components, screws, clamps, rivets, adhesives, locks, friction fitting, plugs, caps, covers, seals, rivets, corks, and stoppers or any combination thereof.
  • the cooperative interaction is a securing mechanism in some
  • distractor engagement in certain embodiments, and is selected from one or more snapping components, screws, clamps, adhesives, locks, rivets, friction fitting, or any combination thereof.
  • Aesthetic considerations such as, for example, smell, appearance, texture, entertainment and the like, which concern an individual when cast immobilization is required for extended (or short) periods of time, are provided in illustrative embodiments of the present invention as described above and further detailed as follows.
  • the present invention provides a plethora of features for enhancing and improving the cast wearing experience.
  • some embodiments of the present invention provide for one or more occlusive fixtures containing a repository.
  • the repository is a liquid repository, which can be a fragrance repository.
  • such embodiments of the present invention provide for a comfortable cast with fragrance enhancement while obviating foul odors associated with cast immobilization.
  • illustrative embodiments of the present invention impart one or more distractors and/or occlusive fixtures as decorative ornamental objects having a surface and/or design that is decorated, colored, patterned, texturized, designable, colorimetric, modifiable, or designable, or any combination thereof.
  • Examples of surface or design configurations and/or ornamental objects that may be attached include, but are not limited to, charms, accessories, entertainment applications, aesthetic components, jewelry, stickers, adhesives, decals, ornaments, styling elements, watch features, watches, calculators, mobile phone accessories, computer and electronic application accessories, holders, make-up and beauty applications, learning and/or educational applications, sports and trading card applications, and the like, all of which are interchnagable and accessible to an individual wearing the orthopaedic cast of the present invention.
  • Such surface configurations and/or objects may also embody, but are not limited to, animals, cars, personalities, structures, words, items, apparel, jewelry, and the like.
  • FIG. 1 is a perspective view of an orthopaedic cast embodiment 100.
  • the cast 120 is circumferentially positioned around the hand (thumb 110 is shown) and arm 111.
  • the conduit positioning on the cast 130 is provided as shown, where conduits 140 are in an open configuration. Positioning 130 imparts the efficiency of silicon bridge conduit manufacturing, moreover.
  • the surface of an occlusive fixture or a distractor end, as placed in a conduit, is provided with decorative design 150 shown.
  • FIG. 2 shows a cross-sectional view of the orthopaedic cast embodiment 100.
  • FIG. 3 is a perspective view of orthopaedic cast conduit embodiment 200 with vents 211. Exterior side surface 210 is shown with vents 211 and interior side surface 212.
  • the lower conduit surface 220 includes an inferior region 222 comprising cylindania 221 and adherence nodes 223.
  • nodes 223 may be conical, frusto-conical, rounded, or flat, they may also be pointed, or burred to anchor conduit 200 securely to a surface, such as, for example, the skin of an arm.
  • Adherence nodes 223 are oriented such that they prevent, or at least minimize the potential for, shifting of conduit 200 during cast application.
  • FIG. 4 shows a perspective view of an orthopaedic cast conduit embodiment 200 with channels 213 in the absence of vents 211. Exterior side surface 210 is solid in the present embodiment, but includes channels 213 as shown.
  • the vents 211, cylindania 221, and channels 213 of conduit embodiment 200 further allow for ventilation, moisture release, drying, aromatic dissemination, heating applications to allow for solidification and/or hardening of the casting material, or any combination thereof, among other applications.
  • FIGs. 5-10 illustrate embodiment 300 of an orthopaedic cast system including conduit 301, occlusive fixture 340, and distractor 350.
  • FIG. 5 depicts a top view illustrating conduit 301 with lower surface 321 and side surface 320.
  • the open cylindrical space 310 formed by conduit side surface 320 is shown, where space 310 is configured to receive an occlusive fixture of the present invention (not shown).
  • FIG. 6 is a cross-sectional view of conduit 301, showing lower surface 321 and side surface 320.
  • Adherence nodes 330 and cylindania 331 are provided as shown and respectively facilitate the positional stability and air flow with respect to conduit 301.
  • FIGs. 7 and 8 respectively illustrate top and cross-sectional views for embodiment 300 of orthopaedic cast conduit 301 with provided occlusive fixture 340 and distractor 350 having a decorative distractor end.
  • the lower surface 321, side surface 320, adherence nodes 330, and cylindania 331 are depicted.
  • Distractor 350 is depicted in concert with distractor body 351 and distractor tip 352, which imparts a mechanism for engagement and/or securement of distractor 350 to occlusive fixture surface 340.
  • the foregoing elements form complex 360, which is shown in an engaged configuration.
  • Adherence nodes 330 and cylindania 331 are also provided as shown.
  • FIG. 9 is a cross-sectional view of orthopaedic cast conduit 301 with provided occlusive fixture 340 and distractor 350, where distractor 350 has been rotated 90° to a disengaged position relative to the engaged configuration of complex 360 shown in FIG. 8.
  • Occlusive fixture lip 341 rests on the top of conduit side surface 320, and distractor 350 is provided in a disengaged configuration.
  • Distractor shaft 351 and tip 352 are shown as labeled.
  • Adherence nodes 330 and cylindania 331 are also provided as labeled. As shown in FIG. 9, the disengaged distractor configuration allows for distractor 350 removal from occlusive fixture 340.
  • FIG. 10 is a side view of embodiment 300 for orthopaedic cast conduit 301 with provided occlusive fixture and distractor 350 with decorative distractor end.
  • the lower surface 321, side surface 320, adherence nodes 330, and cylindania 331 are depicted and function as described above in suitable embodiments.
  • Occlusive fixture lip 341 rests on the top of conduit side wall 320.
  • FIGs. 1 1 and 12 depict alternative embodiments of an occlusive fixture 370, i.e., without a distractor portal and engaged or disengaged distractor.
  • Lower surface portion 371 of concave region 376 is shown in concert with inner side region 372 and outer side region 375.
  • Occlusive fixture lip 341 is shown in conjunction with inferior lip region 373, while occlusive fixture superior surface 377 is provided.
  • Notch 374 is provided in FIGs 11 and 12, which enables a means for removing occlusive fixture 370 from a conduit (not shown).
  • the present invention contemplates the interchangeability of individual features of the present invention with respect to the same features, albeit in modified embodiments, e.g., various distractors or occlusive fixtures may be interchanged in accord with various conduits.
  • the present invention provides methods for making a cast, which includes providing a casting composition composed of at least one layer of reticulated material configured to conform to a body surface that defines a casting region, placing one or more conduits on the casting region surface, encasing the casting region with the one or more conduits on the casting region surface to form an orthopaedic cast having the one or more conduits embedded in the orthopaedic cast, and providing one or more occlusive fixtures capable of cooperatively interacting with the one or more conduits when the one or more occlusive fixtures are substantially aligned with the one or more conduits.
  • the methods further include providing one or more distractors having a distractor tip, distractor body, and a distractor end, where the one or more distractors are configured to reversibly engaged the one or more occlusive fixtures in an engaged configuration, and where the one or more distractors are configured to reversibly disengaged the one or more occlusive fixtures in a disengaged configuration.
  • Such methods further entail, in suitable embodiments, securing the one or more occlusive fixtures to the one or more conduits and/or securing the one or more distractors to the one or more the one or more occlusive fixtures by interacting, e.g., combining, the components to remain connected in some embodiments.
  • the securing is reversible.
  • the occlusive fixtures are in a substantially aligned position with the one or more conduits when in a secured position in some embodiments.
  • Methods of the present invention further include securing the one or more occlusive fixtures to the one or more conduits such that the one or more occlusive fixtures and the one or more conduits interact and remain connected when the one or more occlusive fixtures is in the substantially aligned position with the one or more conduits.
  • methods of the present invention include securing the one or more distractors to the one or more occlusive fixtures such that the one or more distractors and the one or more occlusive fixtures remain connected, when substantially aligned.
  • Orthopaedic immobilization assemblies such as casts, splints, and/or supports, typically employ materials that form, manifest, strengthen, solidify, harden, shape, congeal, polymerize, and the like, via use of water (or other catalyst) catalyzed processes, e.g., adding water and/or allowing for such materials to form for a certain period of time.
  • casting materials may be impregnated with a water hardenable urethane, and, at the time the cast or support is to be applied to the patient, it is dipped into water, applied to the injured part of the anatomy, and, within minutes to hours, solidifies. See, e.g., EP 1372549.
  • the foregoing process occurs in the presence of one or more conduits.
  • the reticulated cast material and/or casting composition to be applied to a patient is selected from silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic- based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof in some embodiments.
  • the foregoing compositions allow for methodical wrapping, placing, making, and/or circumferentially applying the casting material to a body surface.
  • the body surface is an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • the casting region is accordingly realized, which, in illustrative embodiments, includes, but is not limited to, for example, an entire body, lower extremity limbs, upper extremity limbs, one or both shoulders, one or both hips, one or both arms, one or both elbows, one or both hands, one or both wrists, one or both legs, one or both feet, one or both ankles, one or both heels, one or both knees, neck, and head, or any combination thereof.
  • Orthopaedic casts of the present invention typically form, after application to a patient, in minutes, hours, days, or weeks.
  • the cast forms in about from 0.1-100, 0.5-90, 1-80, 1.5-70, 2-60, 2.5-55, 3-50, 3.5-40, 4-30, 4.5-20, 5-15, or 6-7 seconds minutes, hours, or days.
  • the cast forms in about from 0.1-2 hours. It will be readily apparent to the skilled artisan that numerous additional variables can affect cast formation in the presence or absence of the one or more conduits and/or one or more fenestrations.
  • foam edges may also be provided, such as, e.g., two-part polyurethane foam available from Hastings Plastic Company.
  • Typical materials which may be used are silicone, rubber, adhesive, foam, TPE, vinyl, non-water hardenable urethane, and other plastic materials, such as, for example, fiberglass, Kevlar ® , or aramids, for examples, and to materials having comparable high strength, as discussed in U.S. Patent Nos. 6, 139,513, and 6, 186,966. See, e.g., EP 1372549; See also EP 0755664.
  • Bonding material is also provided in some embodiments in the presence or absence of comfort foaming material or other applications as described above.
  • the bonding material may be applied in a variety of ways, such as, for example, by spraying, brushing, pressing, dipping or the like, before or after application of the casting material to the casting region. See, e.g., EP 1372549.
  • adjustments, manipulations, reconfigurations, and the like can be performed, for example, for forming the fenestrations and/or placing the conduits therein, after application of the bonding material.
  • Forming the fenestrations and/or placing the conduits therein, in the cast before, during, or after cast application is also an aspect of the present methods, whereas, in suitable embodiments, casting material is applied after the conduits have been positioned on the patient, thereby concomitantly forming the fenestrations via the conduit. Accordingly, such components will be readily incorporated into the cast as it forms, hardens, and/or solidifies, as further described below.
  • conduits of the present invention having a lower surface and a side surface, where the side surface defines an inner space fenestration for engaging one or more occlusive fixtures, and where the lower surface is positioned adjacent to the body surface-are provided simultaneously, separately, or sequentially, with the casting material when an orthopaedic cast of the present invention is fitted to a patient.
  • the one or more conduits have an exterior surface, where the exterior surface defines a region contacting the casting composition.
  • the height and width of the one or more conduits is described herein as detailed above, and such defined conduits are composed of silicone, rubber, vinyl, non-water hardenable urethane, plastic, plastic-based materials, fiberglass, metal, ceramic, polymers, resin, plaster, scented plastic, cellulose or scented cellulose, such as, for example, AuracellTM or any combination thereof, in illustrative embodiments.
  • the one or more conduits and/or occlusive fixtures are configured, formed, manufactured, provided, pre-formed and/or fabricated as one or more silicone bridges. Such silicone bridges can be manipulated by the user to fit any particular application.
  • the one or more conduits possess one or more vents and/or channels, as described herein. The vents and/or channels facilitate cast application and formation by enabling heating applications, chemical applications, and the like, to hasten cast material solidification and/or hardening.
  • the one or more conduits have one or more adherence nodes positioned throughout the lower surface of the conduit to prevent the conduit from moving while the casting materials are provided.
  • the one or more conduits are one or more orthopaedic cast grommets in some embodiments as provided herein.
  • the casting methods provided herein contemplate that the one or more occlusive fixtures-for example, plugs, screws, caps, covers, seals, corks, and stoppers, or any combination thereof-are positioned to interact, engage, connect, and the like, to the conduit, in the presence or absence of one or more distractors, distractor components, features, and the like.
  • FIG. 13 shows diagrammatic flow-chart 400 representing one process for making an orthopaedic cast of the present invention.
  • operation 410 after stockinette material possessing apertures configured to allow the stockinette to rest on the lower surface (flange region) of a conduit is provided, reticulated material is provided as the casting composition, which is configured to conform to a body surface defining a casting region.
  • operation 420 includes placing one or more conduits on the casting region body surface.
  • the casting region with conduits are encased in operation 430 via the casting composition and therefore form the embedded conduits in the orthopaedic cast.
  • occlusive fixtures are provided which cooperatively interact with the conduits when substantially aligned.
  • distractors comprising a distractor body, distractor tip and a distractor end are provided.
  • the distractors are configured to reversibly engaged and disengage the occlusive fixtures in an engaged and disengaged configuration, respectively, in operation 450.
  • the occlusive fixtures are optionally secured to the conduits such that they remain connected when substantially aligned. See FIG. 13.
  • compositions and methods will be understood more readily by reference to the following example, which is provided by way of illustration and is not intended to be limiting in any way.
  • the patient is triaged and subsequently evaluated by an orthopedic medical professional.
  • Three silicone grommets (2.0" diameter x 0.5" height) are evenly positioned on the arm region to be immobilized. See FIG. 14.
  • the grommet side wall is a solid structure with 9 embedded channels (0.05" wide) positioned throughout the length of the inner grommet side wall (1.5" diameter) such that the channels are in fluid communication with associated cylindania (0.04" protrusion) borne out of the inferior surface of the lower grommet flange region (0.12" height), which also possesses 0.015" x 0.03" adherence nodes on the inferior surface.
  • Adequate stockinette padding is placed at the ulnar styloid and antecubital fossa to decrease skin decomposition, where the stockinette possesses three aperture regions configured to receive and rest upon the conduit lower flange surface.
  • fiberglass casting material is provided, where the fiberglass material is configured to conform to the arm surface that defines an ulnar gutter casting region.
  • the fiberglass material is subsequently wrapped circumferentially around the patient's forearm, penumbral regions, and sitting conduits inasmuch as the cast extends from the proximal one third of the forearm to the distal palmar crease volarly and proximal to the MCP joints dorsally, while leaving the inner surface of the grommets free of the fiberglass material.
  • the fiberglass material is left to form on the patient for 30 min.
  • AuracellTM scented cellulose plugs with distractor entry portal are provided and aligned with the open region formed by the grommet inner side wall.
  • the plug lip rests on the top of the grommet side wall after placement, and a distractor with decorative distractor end is positioned within the entry portal.
  • the distractor is then rotated 90°clockwise to engage the distractor with the plug. Subsequently, the distractor is rotated 90° counterclockwise to disengage the plug and the injury site is examined.

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Abstract

La présente invention concerne des plâtres orthopédiques, des composants de plâtres orthopédiques et des procédés de fabrication et d'utilisation de ces plâtres et composants. Les composants de plâtre de la présente invention comprennent des conduits, des dispositifs occlusifs et des écarteurs, les conduits étant incorporés dans une composition de plâtre sur une surface corporelle de sorte que les dispositifs occlusifs puissent entrer en contact et se fixer sur les conduits.
PCT/US2014/012839 2013-01-24 2014-01-24 Plâtres orthopédiques et leurs procédés de fabrication WO2014116887A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3021798A4 (fr) * 2013-07-15 2017-05-17 Paterson, Paul, Douglas Éléments de fixation pour plâtre orthopédique
CN112006847A (zh) * 2019-05-29 2020-12-01 上海交通大学医学院附属第九人民医院 一种自动化石膏固定机器人

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3762406A (en) * 1971-12-20 1973-10-02 G Wells Surgical cast venting means
US3998220A (en) * 1975-03-31 1976-12-21 Cleer Jr Clarence W Cast venting apparatus
US20080312570A1 (en) * 2007-05-21 2008-12-18 Rick Dunagan Apparatus and method of creating airflow through a breathable orthopedic cast
US20080319362A1 (en) * 2007-06-20 2008-12-25 Mark Joseph Orthopedic System for Immobilizing and Supporting Body Parts
US20100010408A1 (en) * 2008-07-08 2010-01-14 Linares Medical Devices, Llc Body limb cast including an outer rigid shell and inner dynamic members in combination with air circulation and massage features

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3762406A (en) * 1971-12-20 1973-10-02 G Wells Surgical cast venting means
US3998220A (en) * 1975-03-31 1976-12-21 Cleer Jr Clarence W Cast venting apparatus
US20080312570A1 (en) * 2007-05-21 2008-12-18 Rick Dunagan Apparatus and method of creating airflow through a breathable orthopedic cast
US20080319362A1 (en) * 2007-06-20 2008-12-25 Mark Joseph Orthopedic System for Immobilizing and Supporting Body Parts
US20100010408A1 (en) * 2008-07-08 2010-01-14 Linares Medical Devices, Llc Body limb cast including an outer rigid shell and inner dynamic members in combination with air circulation and massage features

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3021798A4 (fr) * 2013-07-15 2017-05-17 Paterson, Paul, Douglas Éléments de fixation pour plâtre orthopédique
CN112006847A (zh) * 2019-05-29 2020-12-01 上海交通大学医学院附属第九人民医院 一种自动化石膏固定机器人

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