WO2025057984A1 - Cranial shape correction helmet - Google Patents
Cranial shape correction helmet Download PDFInfo
- Publication number
- WO2025057984A1 WO2025057984A1 PCT/JP2024/032575 JP2024032575W WO2025057984A1 WO 2025057984 A1 WO2025057984 A1 WO 2025057984A1 JP 2024032575 W JP2024032575 W JP 2024032575W WO 2025057984 A1 WO2025057984 A1 WO 2025057984A1
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- WIPO (PCT)
- Prior art keywords
- helmet
- skull
- shape
- cranial
- liner
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A42—HEADWEAR
- A42B—HATS; HEAD COVERINGS
- A42B3/00—Helmets; Helmet covers ; Other protective head coverings
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- A—HUMAN NECESSITIES
- A42—HEADWEAR
- A42B—HATS; HEAD COVERINGS
- A42B3/00—Helmets; Helmet covers ; Other protective head coverings
- A42B3/04—Parts, details or accessories of helmets
-
- A—HUMAN NECESSITIES
- A42—HEADWEAR
- A42B—HATS; HEAD COVERINGS
- A42B3/00—Helmets; Helmet covers ; Other protective head coverings
- A42B3/04—Parts, details or accessories of helmets
- A42B3/10—Linings
-
- A—HUMAN NECESSITIES
- A42—HEADWEAR
- A42B—HATS; HEAD COVERINGS
- A42B3/00—Helmets; Helmet covers ; Other protective head coverings
- A42B3/04—Parts, details or accessories of helmets
- A42B3/28—Ventilating arrangements
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- 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. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
Definitions
- the present invention relates to a cranial shape correction helmet having a hard outer shell and a soft inner liner used to correct cranial deformities in young children.
- plagiocephaly when an infant's head is viewed from above, the skull is distorted at an angle and tilted to one side, making it asymmetrical.
- dolichocephaly or brachycephaly the front-to-back dimensions of the skull are longer or shorter. If these conditions are left untreated and the distortion progresses, the position of the ears and the face become fixed in a deformed state.
- a treatment method (hereinafter referred to as "helmet treatment”) may be adopted in which a skull shape correction helmet, such as those exemplified in Patent Documents 1 and 2, is placed on the infant's head and the infant goes about their daily life in that position.
- This treatment method makes it possible to gradually return the distorted skull to its normal shape.
- Cranial correction helmets are made to fit the skull of each individual infant being treated, taking into account the current shape of the skull and the expected shape after correction. In other words, cranial correction helmets are made to order. Before being made, the skull of the infant being treated is scanned using a well-known three-dimensional scanning method, and detailed data on its shape is obtained. Then, based on the obtained data, the cranial correction helmet can be made using a 3D printer.
- Helmet therapy is sometimes performed with a skull correction helmet fitted to the skull of the infant being treated for most of the day, including while sleeping (e.g., more than 20 hours a day). Helmet therapy using the skull correction helmet disclosed in Patent Documents 1 and 2 has been shown to have a certain degree of therapeutic effect.
- helmet therapy The main patients in helmet therapy are infants and young children aged between about 3 months and 1 year old, who have a small skull volume and a denser distribution of sweat glands compared to adults. In addition, their thermoregulation function is less developed than that of adults, so there is a natural concern that the skin environment will deteriorate due to sweating. Naturally, children who undergo helmet therapy will wear helmets made of synthetic resin for long periods of time, which increases concerns about the skin environment. In particular, helmets that allow for the quick release of sweat are preferred for helmet therapy, but there are no helmets that specifically address this issue.
- the inventors have discovered that in helmet therapy, it is important to prevent the cranial shape correction helmet from slipping, and based on their many years of experience developing cranial shape correction helmets, whether or not the cranial shape correction helmet fits properly in the first few months after the start of helmet therapy can have a significant impact on the effectiveness and duration of treatment. Based on this knowledge, the inventors have attempted to employ a high-density soft polyurethane layer, which is believed to be able to minimize slippage of the cranial shape correction helmet, particularly in infants who have just started helmet therapy.
- cranial shape correction helmets are still lightweight and easy to maintain, they are usually put on by the parents of infants and young children, and therefore need to be easy to operate when they slip off or when putting on.
- connecting rib which conventionally has a rod-shaped member in the diameter direction of a generally circular hole
- connecting rib with the center of this linear member removed, i.e., by forming a loop at the end of the fixing band and configuring it to hook onto the protrusion
- the present invention aims to provide a cranial correction helmet that solves the above-mentioned problems.
- Another aspect of the present invention is the above-described helmet for correcting cranial shape, characterized in that, when the hard outer shell is attached, the opening area of at least some of the multiple ventilation through holes varies from the vertical center in the upward and downward directions.
- Another aspect of the present invention is the above-described helmet for correcting cranial shape, in which the opening area of at least some of the plurality of ventilation through-holes is largest at the vertical center and gradually decreases away from the center.
- the hole areas of at least some of the plurality of ventilation through holes are arranged symmetrically in the up-down direction from the vertical center.
- Another aspect of the present invention is a helmet for correcting cranial shape described above, in which the spacing between at least some of the multiple ventilation through-holes is symmetrically arranged in the up-down direction from the vertical center.
- Another aspect of the present invention is a helmet for correcting a cranial shape, as described above, in which the distance between the ends of at least some of the multiple ventilation through-holes is configured to gradually increase from the vertical center in the upward and downward directions, and the holes are arranged symmetrically.
- Another aspect of the present invention is a skull shape correction helmet as described above, in which at least some of the multiple ventilation through holes are arranged at equal intervals in an area corresponding to either the frontal bone, the parietal bone, or the occipital bone, or a combination thereof.
- Another aspect of the present invention is a helmet for correcting cranial shape described above, in which at least some of the multiple ventilation through-holes have a hole area sufficient for inserting a diagnostic tool.
- Another aspect of the present invention is a helmet for correcting a cranial shape, as described above, which includes an inner liner that is removably disposed on at least a portion of the inner surface of the outer shell.
- Another aspect of the present invention is a skull shape correction helmet as described above, in which a slit is provided on at least one of the left and right sides of the outer shell.
- the liner includes at least a first foamed synthetic resin layer and a second foamed synthetic resin layer. It is a liner for a helmet that corrects the shape of the skull.
- the foamed resin constituting the foamed synthetic resin layer is any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA crosslinked foam, PET resin foam, and phenol foam.
- the foamed synthetic resin layer constituting the liner is bonded by any one of an adhesive layer, heat fusion and sewing.
- the adhesive layer is one selected from the group consisting of EVA (ethylene vinyl acetate), thermoplastic polyurethane, thermosetting polyurethane, polyester, polyamide, polyolefin, acrylic resin, and rubber, or any combination thereof.
- EVA ethylene vinyl acetate
- thermoplastic polyurethane thermosetting polyurethane
- polyester polyamide
- polyolefin polyolefin
- acrylic resin acrylic resin
- rubber or any combination thereof.
- Another aspect of the present invention is a liner for a skull shape correction helmet as described above, in which the first foamed synthetic resin layer has a different resilience than the second foamed synthetic resin layer.
- Another aspect of the present invention is a liner for a skull shape correction helmet, as described above, in which the first foamed synthetic resin layer has a lower resilience than the second foamed synthetic resin layer.
- Another aspect of the present invention is a liner for a skull shape correction helmet, as described above, in which the first foamed synthetic resin layer and the second foamed synthetic resin layer have different thicknesses.
- the first foamed synthetic layer is thicker than the second foamed synthetic layer.
- FIG. 1 Another aspect of the present invention is a surgical mask that includes an outer shell configured to cover a skull portion, a liner including at least a first foamed synthetic resin layer and a second foamed synthetic resin layer;
- a helmet for correcting a skull shape comprising:
- a slit is formed on at least one side of the left or right side of the head,
- connecting members are provided on both sides of the slit, The at least one connecting member is provided with a protrusion.
- a slit is formed on at least one side of the left or right side of the head,
- connecting members are provided on both sides of the slit,
- the at least one connecting member includes a protrusion;
- a fixing band having a locking portion for the protrusion is included.
- the protrusion includes at least two protrusions protruding from a target position of the at least one connecting member.
- Another aspect of the present invention is a helmet for correcting cranial shape described above, in which the protrusion is tapered toward the tip.
- the locking portion is a ring formed by folding back at least one end of the fixing band in the length direction. It is a skull correction helmet.
- the fixing band is folded back and fixed by a connecting member located on the opposite side of the connecting member that is engaged by the engaging portion of the fixing band.
- a cranial shape correction helmet as described above.
- Another aspect of the present invention is a cranial shape correction helmet as described above, in which the width of the fixing band is the same as or slightly shorter than the width of the connecting hole in the direction perpendicular to the longitudinal direction of the band.
- the skull shape correction helmet of the present invention can efficiently secure a large area of ventilation through-holes on the surface of the helmet, and can maintain a good scalp environment.
- the ventilation through-holes of regular size distortion of the head can be easily confirmed from the outside by visual inspection or by inserting a ruler or the like into the ventilation through-hole.
- the cranial shape correction helmet of the present invention uses an inner liner made of a material suitable for treatment, and with a simple configuration, it is possible to increase the coefficient of friction between the helmet, specifically the inner surface of its outer shell described below, and the skull part having the shape to be treated. This makes it possible to properly maintain the positional relationship between the skull part and the helmet, that is, to suppress the displacement between them due to the body movement of the infant wearing the helmet. As a result, it is possible to prevent the cranial shape correction helmet from being unintentionally removed from the skull part. Since the liner of the present invention uses a low-resilience elastic material, it is possible to reduce the burden on the skull part of the infant.
- the cranial shape correction helmet of the present invention makes the liner easily removable by joining the helmet body and the liner with a hook-and-loop fastener member. This makes it possible to change the shape by appropriately removing the member according to the progress of treatment, making it possible to perform effective treatment.
- the structure of the fixing band can also be simplified, making it possible to provide a cranial shape correction helmet that is convenient not only when worn but also when it comes to maintenance.
- FIG. 1 is a schematic overall front view of one embodiment of a cranial contouring helmet as described herein.
- FIG. 2 is a diagram illustrating the construction of the liners described herein.
- FIG. 3 is an exploded partial perspective view showing the relationship between an inner liner and a hook-and-loop fastener member used in the helmet described herein.
- FIG. 4 is a perspective view of another embodiment of a cranial contouring helmet described herein.
- FIG. 5 is a rear view of the helmet shown in FIG.
- FIG. 6 is a bottom view of the helmet shown in FIG.
- FIG. 7 is a front view of a skull shape correction helmet according to another embodiment of the present invention.
- FIG. 8 is a rear view of a skull shape correction helmet according to another embodiment of the present invention.
- FIG. 1 is a schematic overall front view of one embodiment of a cranial contouring helmet as described herein.
- FIG. 2 is a diagram illustrating the construction of the liners described herein.
- FIG. 16 is a diagram illustrating a fixing band of a cranial shape correction helmet constructed according to the present invention.
- FIG. 17 is a diagram illustrating a fixing band of a cranial shape correction helmet constructed according to the present invention.
- FIG. 18 is a diagram showing the use of a fixing band in a conventional cranial shape correcting helmet.
- FIG. 19 is a diagram showing a fixing band in a conventional cranial shape correction helmet.
- FIG. 20 is a diagram showing an example of a conventional cranial shape correcting helmet when the fixing band is attached.
- the hard shell constituting the cranial shape correction helmet is herein defined as "made of synthetic resin and can be manufactured by a 3D printer.
- a 3D printer In view of the purpose of the cranial shape correction helmet of the present invention, in order to manufacture a helmet that is tailored to the head of an individual patient, it is preferable to manufacture the helmet individually using a 3D printer, since head shape information is obtained using an image recognition application or the like and then the helmet is manufactured to match the target shape.
- the manufacturing method using a 3D printer can be appropriately selected. Such manufacturing methods include, but are not limited to, Material Extrusion, Vat Polymerization, Powder Bed Fusion, particularly selective laser sintering, Material Jetting, Binder Jetting, Direct Energy Deposition, and Sheet Lamination.
- the "outer shell” described in this specification is not particularly limited in terms of material, etc., so long as it is capable of being provided with a hook-and-loop fastener member on at least a portion of its inner surface side.
- the outer shell may be made of, for example, a synthetic resin.
- synthetic resins include, but are not limited to, polyamide (nylon), polycarbonate, polyester, polyacetal, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polybutylene, ABS resin, cellulose-based resin, acrylic resin, epoxy resin, and fluororesin.
- the outer shell is preferably made of polyamide, especially polyamide 12.
- the Shore D hardness of the outer shell 100 after molding is preferably, for example, about 70 to about 85, especially about 75 to about 80.
- the outer shell is made of a synthetic resin (preferably polyamide, more preferably polyamide 12).
- a hook-and-loop fastener member can be provided on at least a portion of the inner surface side of the outer shell.
- a hook-and-loop fastener is not particularly limited in size, shape, material, position, etc., as long as it can be removably attached to the adhesive layer of the inner liner described later.
- the shape of the hook-and-loop fastener member is not limited to these, but examples include an approximately triangular, approximately rectangular, approximately square, approximately pentagonal, approximately hexagonal, approximately circular, and approximately elliptical shape.
- the hook-and-loop fastener member may be provided on approximately the entire inner surface of the outer shell, or may be provided on a portion of the inner surface of the outer shell.
- one or more hook-and-loop fastener members may be provided, for example, at a position corresponding to the forehead, positions corresponding to both sides of the head, and/or positions corresponding to the back of the head.
- the outer shell may have a slit between the front and rear shells. This allows the slit to be opened appropriately in accordance with the growth of the skull, making it easy to adjust the relative positions of the front and rear shells.
- the slit may extend from the upper edge to the lower edge of both sides of the head. This allows the outer shell to be separated into a front shell and a rear shell.
- slits are provided on both sides of the head of the outer shell.
- the slits extend from the upper edge to the lower edge of both sides of the head, dividing the outer shell into a front shell and a rear shell.
- the surface of the outer shell may have a mesh structure or may have multiple ventilation holes. This allows for good ventilation between the inside and outside of the cranial shape correction helmet, which is expected to have advantageous effects in terms of dissipating sweat from the infant being treated and dissipating heat generated inside the cranial shape correction helmet.
- the mesh in the area where the hook-and-loop fastener member is attached may be finer than in other areas (i.e., areas where the hook-and-loop fastener member is not attached), or the mesh may be filled in. This increases the contact area between the outer shell and the hook-and-loop fastener member, allowing the hook-and-loop fastener member to be attached more firmly.
- the outer shell has a mesh structure.
- the mesh size of the outer shell can be changed as appropriate.
- a doctor may check the distance between the inside of the helmet and the head to be corrected by inserting a finger, pen, ruler, etc. through holes in the mesh to check the growth of the skull. For this reason, enlarging the mesh in at least a portion of the left and right back of the head can make the doctor's examination easier.
- the outer shell may have its peripheral portion reinforced by a peripheral reinforcement portion.
- the peripheral reinforcement portion may be configured to be thicker than the remaining portion of the outer shell (portion excluding the peripheral reinforcement portion).
- the cross-sectional shape of the peripheral reinforcement portion is not particularly limited, but may be, for example, a so-called circular border that is approximately circular with a diameter of about 4 to about 8 mm.
- the thickness of the portion of the outer shell excluding the peripheral reinforcement portion may be, for example, about 2 to about 4 mm.
- the peripheral reinforcement portion may be, for example, a portion where the thickness is increased in the peripheral portion of the front shell and the peripheral portion of the rear shell together with the approximately circular upper edge that defines the summit opening.
- the thickness of the peripheral portion of the outer shell is greater than the thickness of the other portions.
- a pair of reinforcing parts may be provided vertically on both front side surfaces of the outer shell.
- the baby's ears can be inserted into the resulting curved parts, making it possible to generally fix the positional relationship between the cranial shape correction helmet and the skull part.
- This configuration can make the positional relationship between the helmet and the skull part more stable.
- a thickened member attachment, etc.
- a thickened member that protrudes from the inner surface of the outer shell toward the skull part may be partially provided on the inner surface of the outer shell.
- the outer shell further has a pair of reinforcing parts in the vertical direction on both front side surfaces.
- the skull shape correction helmet of the present invention is composed of a front shell and a rear shell, and these shells can be joined and fixed using the slits described above and a fixing band made of a hook-and-loop fastener or the like on the connecting member.
- this connecting member By configuring this connecting member to be thicker than the average thickness of the shell, a part that is firmly fixed within the mesh structure is secured, and shape distortion of the entire shell can be suppressed.
- the connecting member has at least two protruding parts from both ends of the long side diameter of the ellipse.
- the shape of the connecting member is not particularly important as long as it is possible to form a protruding member from both ends in question. Therefore, it is preferable that the connecting member has a connecting member hole.
- the attachment of the fixing band can be made easier by adjusting the width of the engaging part of the fixing band described below and the width of the connecting hole.
- the liner used in the lid shape correction helmet of the present invention is formed by bonding a first foamed synthetic resin layer and a second foamed synthetic resin layer with an adhesive layer.
- foamed synthetic resins are preferably any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA cross-linked foam, PET resin foam, and phenol foam.
- Polyurethane resin is particularly preferred from the viewpoints of processability and cost.
- the first polyurethane layer is the layer that faces the head when the helmet is worn.
- the first polyurethane layer is a soft polyurethane layer having a high density, and is not particularly limited as long as it can be adhered to the second polyurethane layer via an adhesive layer.
- the liner may be only the first polyurethane layer and the second polyurethane layer, or may include other layers between them.
- the liner can be of a desired thickness taking into consideration the size of the outer shell and the infant's skull, etc.
- the liner may be one member or multiple members. From the viewpoint of ease of replacement (e.g., so that only the parts soiled with sweat etc. can be replaced), it is preferable that the liner be multiple members (e.g., 2 to about 10 members, preferably 2 to about 6 members).
- the first polyurethane layer described in this specification may be a "soft polyurethane layer".
- the term "soft polyurethane layer” is not particularly limited as long as it is a layer whose main material is soft polyurethane.
- soft polyurethane include, but are not limited to, polyester foam and polyether foam, and preferably polyester foam.
- the soft polyurethane layer may be a single layer or multiple layers (for example, a combination of two or more types of soft polyurethane layers with different resilience and density).
- the thickness of the soft polyurethane layer is not particularly limited as long as the object of the present invention can be achieved, but may be, for example, about 1 to about 50 mm, preferably about 2 to about 40 mm, more preferably about 3 to about 30 mm, and even more preferably about 4 to about 20 mm.
- the first polyurethane layer described in this specification is preferably low-resilience (resilience of, for example, about 0 to about 50% (about 50 or less), preferably about 0 to about 40% (about 40% or less), and more preferably about 0 to about 30% (about 30% or less)).
- resilience is a numerical value that represents the ratio of the applied force to the rebound force, expressed as a percentage. For example, a resilience of 100% means that when a weight is dropped on the material, the weight will rebound to its original position (original height), and conversely, a resilience of 0% means that it does not rebound at all and remains stationary in place.
- the first polyurethane layer described in this specification can also be expressed as a "soft polyurethane layer having a high density.”
- a "soft polyurethane layer having a high density” refers to a soft polyurethane layer having a density of 0.05-0.5 g/cm3 and a rebound resilience of 20% to 60%. By using a soft polyurethane layer having a high density, a higher therapeutic effect can be expected.
- the first and second foamed synthetic resin layers can be attached together by any suitable means, such as an adhesive layer, heat fusion or stitching.
- the second foamed synthetic resin layer described in this specification also functions as an "adhesive layer" of the hook-and-loop fastener member provided on the inside of the shell.
- the "adhesive layer” is not particularly limited as long as at least a portion of at least one surface can be detachably joined to the hook-and-loop fastener member provided on the inner surface of the outer shell.
- the adhesive layer may be a single layer or multiple layers.
- the adhesive layer is not limited to these, but examples include nylon and hook-and-loop fasteners (e.g., if the hook-and-loop fastener member provided on the inner surface of the outer shell includes a hook shape, then a loop shape, and if the hook-and-loop fastener member provided on the inner surface of the outer shell includes a loop shape, then a hook shape).
- the thickness of the second polyurethane layer is not particularly limited as long as the object of the present invention can be achieved, but can be appropriately selected, for example, between about 2 and about 20 mm.
- the first polyurethane layer and the second polyurethane layer are bonded together via an adhesive layer to form the liner of the present invention.
- the first polyurethane layer and the second polyurethane layer are made of expanded polyester foam.
- the first polyurethane layer and the second polyurethane layer are bonded together via an adhesive layer to form a liner.
- the adhesive layer is made of an adhesive, and examples of the adhesive may be one selected from the group consisting of EVA (ethylene vinyl acetate), thermoplastic polyurethane, thermosetting polyurethane, polyester, polyamide, polyolefin, acrylic resin, and rubber, or any combination of these.
- EVA ethylene vinyl acetate
- thermoplastic polyurethane thermosetting polyurethane
- polyester polyamide
- polyolefin acrylic resin
- rubber or any combination of these.
- the first polyurethane layer is softer than the second polyurethane layer.
- the second polyurethane layer engages with a hook-and-loop fastener provided on the inside of the shell and is firmly attached. If only the attachment to the hook-and-loop fastener is considered, the second polyurethane layer may be made of the same hook-and-loop fastener, or may be substituted with a nylon cloth with a suitably brushed surface. However, since the liner of the present invention is worn by infants for long periods of time and it is preferable to keep it clean, it is preferable to use a polyurethane layer that is easy to wash with water and dries quickly.
- FIG. 1 shows one embodiment of the skull correction helmet described in this specification.
- the skull correction helmet 1 shown in FIG. 1 has a liner 20 on the inner surface side of the outer shell 10 so as to cover the wearer's skull.
- the liner 20 includes a first polyurethane layer and a second polyurethane layer.
- the elasticity and thickness of this inner liner 20 gradually corrects the shape of the skull of the infant or child being treated. Note that while the inner liner 20 is provided on the entire inner surface in FIG. 1, it may be provided only in areas deemed necessary, taking into consideration the treatment method, the shape of the skull, etc.
- polyester foam with low resilience (for example, resilience of 30% or less) so that the effects of treatment can be obtained while reducing the burden on the infant being treated.
- low-resilience polyester foam has a larger coefficient of friction when it comes into surface contact with the skull, and therefore is less likely to slip on each other. For this reason, when used as a cushion for the inner surface of a helmet, problems such as misalignment of the skull shape correction helmet and the skull part, or even the unintentional removal of the skull shape correction helmet from the skull part, are less likely to occur. For this reason, low-resilience polyester foam may be used as the first polyurethane layer 22 of the inner liner 20 that is affixed to the inner surface of the outer shell 10 of the skull shape correction helmet 1 shown in Figure 1.
- the inner liner 20 be attached to the inner surface of the outer shell 10 of the cranial shape correction helmet 1 and not move from the inner surface, and in this respect, it is considered to firmly attach it using double-sided tape or the like.
- the shape of the cranial shape correction helmet itself is often adjusted depending on the progress of treatment and the growth of the skull, and it is desirable that the cranial shape correction helmet body and the inner liner are configured to be detachable.
- the inner liner 20 and the inner surface of the outer shell 10 are pressed together with a hook-and-loop fastener member 40 to fix their positional relationship.
- the entire surface of the hook-and-loop fastener member 40 is configured in the shape of tiny hooks made of the material itself, and by engaging with the material of the opposing surface, the surfaces are pressed together.
- FIG. 1 four circular hook-and-loop fastener members 40a, 40b, 40c, and 40d are used, and are placed on the forehead, both sides of the head, and the back of the head, respectively.
- One side of each of these hook-and-loop fastener members 40 is a so-called pressure-bonded surface, which is made up of tiny hooks of the material itself.
- the surface of the inner liner 20 is provided with an adhesive layer (nylon sheet) 22, which will be described later. Therefore, the hook-and-loop fastener member 40 is pressure-bonded to the inner liner 20 via this nylon sheet 22.
- the other side of the hook-and-loop fastener member 40 is firmly fixed to the inner surface of the outer shell 10 with an adhesive or the like.
- the hook-and-loop fastener member is not limited to such a form in which one side is a pressure-bonded surface, and a hook-and-loop fastener member consisting of hook-and-loop fastener pieces having a pair of opposing pressure-bonded surfaces, as will be described later, may be used, and each of the hook-and-loop fastener pieces may be provided on the inner surface of the inner liner 20 and the outer shell 10.
- a pair of reinforcing parts 30 are provided in the vertical direction on both front side surfaces of the outer shell 10.
- the provision of the reinforcing parts 30 allows the baby's ears to be inserted into the resulting curved parts, so that the positional relationship between the skull shape correction helmet 1 and the skull part is generally fixed.
- This configuration makes the positional relationship between the helmet and the skull part more stable.
- an attachment (not shown) that protrudes from the inner surface of the outer shell 10 toward the skull part may be partially provided on the inner surface of the outer shell 10.
- Figure 2 shows one embodiment of the inner liner 20 of the present invention.
- the liner 20 is made up of a first polyurethane layer 22 and a second polyurethane layer bonded together via an adhesive layer 23.
- the first polyurethane layer 22 is configured to be thicker than the second polyurethane layer 21.
- FIG. 3 is a perspective view showing in an even easier-to-understand manner the state when the inner liner 20 and the inner surface of the outer shell 10 of the skull correction helmet 1 are pressed together via the hook-and-loop fastener member 40.
- the surface of the hook-and-loop fastener member 40 has a pressing surface 41, the entire surface of which is formed in a minute hook shape so that it can be engaged with the surface of another material, which is pressed together with the surface of the inner liner 20 via the nylon sheet 21 in the direction of the arrow A.
- the other surface 42 is fixed to the inner surface of the outer shell 10 of the skull correction helmet 1 with an adhesive or the like in the direction of the arrow B.
- the surface of the outer shell 10 is configured to have a stylish mesh structure 400.
- This allows for good ventilation between the inside and outside of the skull correction helmet, and is excellent in terms of dissipating sweat from the infant being treated and dissipating heat generated inside the skull correction helmet.
- the use of a mesh structure allows for a reduction in the amount of material used, making it possible to reduce the weight of the main body and lower the price.
- the orientation of the resin is dispersed, resulting in excellent mechanical strength.
- the design of the shell exterior can be modified as needed.
- a relatively large eye is provided at the back of the head, allowing the doctor to insert a stick or pen into the eye to check the growth of the skull (Figure 5).
- FIG. 6 there is shown yet another embodiment of the skull shape correction helmet according to the present invention.
- a slit 6 is provided in the vertical direction in either the left or right direction of the outer shell 10. This configuration contributes to the breathability of the shell 10 and also contributes to the deflection of the shell body, making it easier to attach the connecting band (not shown).
- the skull shape correction helmet is viewed from below to explain the attached state of the liner of the present invention.
- the liner is depicted as one continuous piece, but it is also within the scope of the present invention to use liners that are divided at suitable positions in the front, back, left, and right directions.
- Fig. 7 is a diagram showing one embodiment of the skull shape correction helmet according to the present invention.
- the skull shape correction helmet 100 shown in Fig. 1 has ventilation through holes 3 on the surface of the outer shell 10. Diamond-shaped holes are arranged regularly in Fig. 1, but the shape of the ventilation through holes in the present invention is not limited to this.
- the skull shape correction helmet according to the present invention can also have a cushioning part for the head on the inside, and is usually equipped with a liner of about 2 mm to 20 mm made of foamed synthetic resin. The liner can be attached directly or indirectly to the skull shape correction helmet 1, and the attachment means is not important to the present invention.
- Fig. 7 shows an attachment part 3 for providing a hook-and-loop fastener on the inside of the skull shape correction helmet 1 as one embodiment.
- the ventilation through holes 4 provided in the cranial shape correction helmet 1 of the present invention will be described.
- the ventilation through holes 3a-3g are regularly arranged on the cranial shape correction helmet 1.
- the area is gradually reduced vertically from the center. With this configuration, it is possible to efficiently ensure the ventilation area on the helmet surface, while also reinforcing the nape and top of the head by increasing the resin density.
- the ventilation holes 3a〜3g are arranged in the same horizontal row, and the ventilation holes 3a〜3g can be arranged symmetrically on the left and right sides of the helmet as a whole.
- the ventilation holes 3a〜3g can be arranged symmetrically on the left and right sides of the helmet as a whole.
- the skull shape correction helmet 100 of the present invention has a substantially spherical helmet shape, a top opening 8 and a lower opening 9 through which the face and other parts come out, a slit 6 is formed on the side of the head, and a connecting member 5 is arranged in a horizontal position in front of and behind the slit 6.
- the slit on the side of the head may be on only one side as shown in Figure 10, or on both sides.
- the slit 6 may simply be a groove, or may be configured so that the rear end fits into the front end (or vice versa).
- the connecting member 5 has protrusions on both ends of the long side diameter of an ellipse.
- the shape of the connecting member is not particularly important, as long as it has a shape and size that allows it to be fixed with the fixing band A ( Figure 13).
- a pair of reinforcing parts 7 are provided in the vertical direction on both front sides of the skull shape correction helmet 100.
- the baby's ears can be inserted into the resulting curved part, and the positional relationship between the skull shape correction helmet 1 and the skull part can be roughly fixed.
- FIG. 7 the interior of the cranial shape correction helmet 100 is provided with an inner liner 20.
- Inner liner adhesive part 4 for engaging the inner liner 20 is shown in FIG. 7.
- the inner liner adhesive part 4 can be attached to the inner liner with a hook-and-loop fastener. This configuration makes it easy to put on and take off the inner liner for the purpose of protecting the head.
- the inner liner adhesive part 4 can be attached in multiple places on the inside of the cranial shape correction helmet 1. It is not intended in the present invention to limit the adhesive means for the inner liner to the above.
- the material of the inner liner is not particularly limited, but examples include foamed synthetic resin, preferably foamed polyurethane, foamed nylon, and more preferably open-cell foamed polyurethane (for example, product name "Memory Foam CF-45").
- the thickness of the inner liner is, but is not limited to, for example, about 1 to about 50 mm, preferably about 3 to about 40 mm, and more preferably about 5 to about 16 mm.
- the inner liner 200 may also be configured to have a ball resilience of about 15% or less.
- thickening members (not shown) in desired positions on the forehead and/or back of the neck and/or left and right sides of the head in addition to the inner liner, it is possible to further reduce deviations between the shape of the cranial shape correction helmet and the shape of the patient's skull, and to further reduce unnecessary vibrations of the cranial shape correction helmet.
- the fixing band A used in the skull shape correction helmet 100 of the present invention may be made of any material and any fastening means as long as it can engage with the fixing member 5 and fasten the bands together.
- the fixing band A has a loop on one side that engages with the protruding part of the connecting member 5 in FIG. 1, and that the opposing surface in the folded state has a hook-and-loop fastener configuration that can be fastened with a loop shape and a hook portion.
- the connecting member 5 is configured in an elliptical shape, and protrusions are configured from the opposing ends in the long side diameter direction toward the center of the connecting member 5 (4U and 4D).
- the protrusion at the top in the vertical direction is 4U
- the protrusion configured on the lower side is 4D.
- the cylindrical portion of the fixing band A having the engagement portion e at the cylindrical end is engaged with the protrusions 4U and 4D, and the fixing band can be attached to the hard outer shell 10. It is preferable that the width of the engagement portion e is shorter by about 0.5 to 1 mm than the height direction H of the connecting member hole 55 shown in FIG.
- the diameter of the tube of the engagement portion e is preferably shorter by about 0.5 to 1 mm than the width W of the connecting member hole 55.
- the size of the engagement portion e can be appropriately changed according to such conditions.
- the surfaces of the protrusions 4U and 4D may be made of a material or have irregularities that tend to generate frictional forces.
- Figure 15 describes the configuration of the fixing band.
- the end f of the fixing band is folded to a suitable length according to the size of the connecting member 5, the connecting member hole 55 and the protruding parts 4U and 4D as described above, so as to match the dotted line a, and fixed by sewing or the like.
- the engaging part e is configured in a cylindrical shape as shown in Figure 17, and the fixing band A can be attached to the hard shell by appropriately folding it and engaging it with the protruding parts 4U and 4D.
- the width h of the fixing band is manufactured after adjusting the size to the height H of the connecting member hole 55 as described above.
- Figure 17 is a view of the fixing band A seen from the thickness direction. As shown in Figure 15, by folding and sewing f to match a, a ring is formed and the engaging part e becomes cylindrical.
- FIGs 15, 16 and 17 show an example of a fixing band with a locking portion e on one side.
- the fixing band can be passed through the connecting member and then fixed with the hook-and-loop fastener.
- one of the opposing faces of the fixing band has a fine loop structure and the other has a fine hook structure, so that the locking portion e of the individual band is hung on the protruding portion of the connecting member and the band can be fixed by engaging the loop structure and hook structure with each other by simply moving it back and forth once.
- the fixing band A can fix the cranial shape correction helmet by simply moving it back and forth once between the three connecting members.
- the fixing band A is engaged with the connecting member 5.
- the width of the fixing band A is slightly shorter than the height of the connecting hole 55 of the connecting member 5, so that the fixing band 40 is engaged with the connecting hole by being caught on the protrusions 4U and 4D.
- FIG 19 shows a conventional fixing band.
- the conventional fixing band is a hook-and-loop fastener band with male loops on one side and female loops on the other side, with a tube passed through it.
- the band is passed through a connecting member, folded back and passed through the tube, and then passed through the connecting member on the other side, and finally the band is passed between the connecting members in one and a half round trips, and the band is secured in three layers.
- a conventional fixing band with such a configuration as the present invention, not only can it be easily removed from the hard shell when putting on or taking off the helmet, but the configuration of the fixing band can also be simplified, making it possible to provide a skull shape correction helmet that is convenient not only when putting on the helmet but also when managing it.
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Abstract
Description
本発明は、幼児の頭蓋変形の矯正に使用される硬質外側シェルと軟質内側ライナーとを具備する頭蓋形状矯正ヘルメットに関する。 The present invention relates to a cranial shape correction helmet having a hard outer shell and a soft inner liner used to correct cranial deformities in young children.
人間の乳幼児、特に生後3カ月程度を経過した乳児には、頭蓋部分の形状が歪む、いわゆる斜頭症、長頭症または短頭症などの症状が現れることがある。例えば斜頭症では、乳児の頭部を上方から見た際に、頭蓋が斜めに歪んで片側に傾斜し、左右非対称になる。長頭症または短頭症では、頭蓋の前後方向の寸法が長くまたは短く変形する。そして、これらのような状態を放置して歪みが進行すると、耳の位置や顔面が変形した状態で固定されてしまう。 Human infants, especially those over about three months of age, can show symptoms such as plagiocephaly, dolichocephaly, or brachycephaly, in which the shape of the skull is distorted. For example, in plagiocephaly, when an infant's head is viewed from above, the skull is distorted at an angle and tilted to one side, making it asymmetrical. In dolichocephaly or brachycephaly, the front-to-back dimensions of the skull are longer or shorter. If these conditions are left untreated and the distortion progresses, the position of the ears and the face become fixed in a deformed state.
このようなことから、症状に応じて、特許文献1および2に例示されるような頭蓋形状矯正用ヘルメットを乳児の頭部に被嵌させて、その状態で日常生活を送る、という治療方法(以下「ヘルメット治療」ともいう。)が採用されることがある。この治療方法により、歪んだ頭蓋の形状を、徐々に正常に戻すことが可能になる。 For this reason, depending on the symptoms, a treatment method (hereinafter referred to as "helmet treatment") may be adopted in which a skull shape correction helmet, such as those exemplified in Patent Documents 1 and 2, is placed on the infant's head and the infant goes about their daily life in that position. This treatment method makes it possible to gradually return the distorted skull to its normal shape.
頭蓋形状矯正用ヘルメットは、現在の頭蓋部分の形状と矯正後に想定される形状とを考慮して、治療の対象となる乳児個々の頭蓋部分に合わせて作成される。即ち、頭蓋形状矯正用ヘルメットは、いわゆるオーダーメイドにより作成される。その作成前には治療対象の乳児の頭蓋部分を周知の三次元スキャン方式によりスキャンし、その形状に関する詳細なデータを入手する。そして、得られたデータに基づき、3Dプリンタにより頭蓋形状矯正用ヘルメットを作成することができる。 Cranial correction helmets are made to fit the skull of each individual infant being treated, taking into account the current shape of the skull and the expected shape after correction. In other words, cranial correction helmets are made to order. Before being made, the skull of the infant being treated is scanned using a well-known three-dimensional scanning method, and detailed data on its shape is obtained. Then, based on the obtained data, the cranial correction helmet can be made using a 3D printer.
ヘルメット治療は、睡眠中も含めて一日のほとんどの時間(例えば、1日20時間以上)、治療対象となる乳児の頭蓋に頭蓋形状矯正用ヘルメットを被嵌した状態で行われることがある。そして、特許文献1および2に開示されている頭蓋形状矯正用ヘルメットを用いたヘルメット治療により、一定程度の治療効果を得られていた。 Helmet therapy is sometimes performed with a skull correction helmet fitted to the skull of the infant being treated for most of the day, including while sleeping (e.g., more than 20 hours a day). Helmet therapy using the skull correction helmet disclosed in Patent Documents 1 and 2 has been shown to have a certain degree of therapeutic effect.
ヘルメット治療において、主に患児となる生後3カ月程度〜1歳未満の乳幼児は、頭蓋体積が小さく大人と比較して汗腺が密に分布している。また、体温調節機能の大人と比較して未熟であることから、発汗作用による肌環境の悪化が当然に懸念される。当然に、ヘルメット治療を行う患児は合成樹脂製のヘルメットを長時間装着するため、肌環境に関する懸念が大きくなる。とくに、ヘルメット治療においては、汗を素早く放出できる機能が好まれているが、具体的にこの問題に対応するヘルメットはない。 The main patients in helmet therapy are infants and young children aged between about 3 months and 1 year old, who have a small skull volume and a denser distribution of sweat glands compared to adults. In addition, their thermoregulation function is less developed than that of adults, so there is a natural concern that the skin environment will deteriorate due to sweating. Naturally, children who undergo helmet therapy will wear helmets made of synthetic resin for long periods of time, which increases concerns about the skin environment. In particular, helmets that allow for the quick release of sweat are preferred for helmet therapy, but there are no helmets that specifically address this issue.
また、発明者らは、ヘルメット治療においては、頭蓋形状矯正ヘルメットのずれを防止することが重要であるところ、本発明者らは、長年の頭蓋形状矯正ヘルメットの開発経験に基づき、ヘルメット治療では治療開始してから最初の数カ月程度において頭蓋形状矯正ヘルメットを適切に被嵌できているか否かが、治療効果と治療期間に大きな影響を与えうる、という新たな知見を見出した。本発明者らは、かかる知見にも基づき、特にヘルメット治療を開始して間もない乳幼児においては、頭蓋形状矯正ヘルメットのズレを極力抑制することが可能と考えられる、高密度を有する軟質ポリウレタン層を採用することを試みた。 Furthermore, the inventors have discovered that in helmet therapy, it is important to prevent the cranial shape correction helmet from slipping, and based on their many years of experience developing cranial shape correction helmets, whether or not the cranial shape correction helmet fits properly in the first few months after the start of helmet therapy can have a significant impact on the effectiveness and duration of treatment. Based on this knowledge, the inventors have attempted to employ a high-density soft polyurethane layer, which is believed to be able to minimize slippage of the cranial shape correction helmet, particularly in infants who have just started helmet therapy.
しかしながら、本発明者らは、高密度を有する軟質ポリウレタン層を内側ライナーとして採用し、面ファスナー部材を介して外側シェルに貼着することを試みたところ、面ファスナー部材への結合が極めて弱いか、又は面ファスナー部材に全く結合しない結果、内側ライナーの位置が極めて容易にずれてしまい、頭蓋形状矯正ヘルメットとして満足いくものが得られない、という新たな課題も見出していた。 However, when the inventors tried to use a high-density soft polyurethane layer as the inner liner and attach it to the outer shell via a hook-and-loop fastener, they found that the bond to the hook-and-loop fastener was extremely weak, or did not bond to the hook-and-loop fastener at all, so the inner liner easily shifted out of position, and they found a new problem: they could not obtain a satisfactory skull correction helmet.
また、本発明らは、頭蓋形状矯正ヘルメットは依然として軽量でメンテナンスが容易である一方で、通常は装着者である乳幼児の親が装着させるため、ずれた時や装着時の操作が容易である必要があることにも鑑み、連結用リブ(従来は通常略円形の孔の直径方向に棒状の部材を備えてなる)を、この直線状の部材の中央部分を削除した連結用リブ、すなわち略円形の直線方向の端部のみに、円心方向に延びる突起を備えてなる連結用リブとし、固定用バンドの端部に輪を構成して、前記突起に引っ掛けるような構成とすることで、固定用バンドを一重にすることができ、バンドの脱着操作を容易にできる頭蓋矯正ヘルメットを提供できることを見出した。 Furthermore, the inventors of the present invention have found that while cranial shape correction helmets are still lightweight and easy to maintain, they are usually put on by the parents of infants and young children, and therefore need to be easy to operate when they slip off or when putting on. In light of this, they have found that by changing the connecting rib (which conventionally has a rod-shaped member in the diameter direction of a generally circular hole) to a connecting rib with the center of this linear member removed, i.e., by forming a loop at the end of the fixing band and configuring it to hook onto the protrusion, it is possible to provide a cranial correction helmet that can make the fixing band single-layered and make it easy to put on and take off the band.
本発明は、上述した課題を解消した頭蓋矯正ヘルメットを提供することを目的とする。 The present invention aims to provide a cranial correction helmet that solves the above-mentioned problems.
上述した課題を解決するために構成した本発明の第一の態様は、
頭蓋部分を覆うように構成された硬質外側シェルに、複数個の通気用貫通孔が形成されている頭蓋形状矯正用ヘルメット、である。
The first aspect of the present invention configured to solve the above-mentioned problems is as follows:
This is a skull shape correction helmet having a hard outer shell configured to cover the skull portion and having a plurality of ventilation through holes formed therein.
また、本発明の他の態様は、前記硬質外側シェルを装着した状態で、その垂直方向中央部より、上下方向に向けて前記複数個の通気用貫通孔の少なくとも一部の孔面積が異なることを特徴とする、上記記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is the above-described helmet for correcting cranial shape, characterized in that, when the hard outer shell is attached, the opening area of at least some of the multiple ventilation through holes varies from the vertical center in the upward and downward directions.
また、本発明の他の態様は、前記複数の通気用貫通孔の少なくとも一部の孔面積は垂直方向中央部が最も大きく、中央部から離れるにしたがって、漸次小さくなるように構成されている、上記記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is the above-described helmet for correcting cranial shape, in which the opening area of at least some of the plurality of ventilation through-holes is largest at the vertical center and gradually decreases away from the center.
また、本発明の他の態様は、前記複数の通気用貫通孔の少なくとも一部の孔面積が垂直方向中央部から上下方向に対称的に配置されてなる、
上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。
In another aspect of the present invention, the hole areas of at least some of the plurality of ventilation through holes are arranged symmetrically in the up-down direction from the vertical center.
A helmet for correcting cranial shape as described above.
また、本発明の他の態様は、前記複数の通気用貫通孔の少なくとも一部の孔間隔が垂直方向中央部から上下方向に対称的に配置されてなる、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a helmet for correcting cranial shape described above, in which the spacing between at least some of the multiple ventilation through-holes is symmetrically arranged in the up-down direction from the vertical center.
また、本発明の他の態様は、前記複数の通気用貫通孔の少なくとも一部の孔端部の間隔が垂直方向中央部から上下方向に漸次大きくなるように構成されている、対称的に配置されてなる、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a helmet for correcting a cranial shape, as described above, in which the distance between the ends of at least some of the multiple ventilation through-holes is configured to gradually increase from the vertical center in the upward and downward directions, and the holes are arranged symmetrically.
また、本発明の他の態様は、前記複数個の少なくとも一部の通気用貫通孔が前頭骨、頭頂骨および後頭骨のいずれかもしくはこれらの組合せに対応する領域において、等間隔で配置されている、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a skull shape correction helmet as described above, in which at least some of the multiple ventilation through holes are arranged at equal intervals in an area corresponding to either the frontal bone, the parietal bone, or the occipital bone, or a combination thereof.
また、本発明の他の態様は、前記複数個の少なくとも一部の通気用貫通孔が診断具を挿入するのに十分な孔面積である、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a helmet for correcting cranial shape described above, in which at least some of the multiple ventilation through-holes have a hole area sufficient for inserting a diagnostic tool.
また、本発明の他の態様は、前記外側シェルの内表面の少なくとも一部に脱着可能に配設される内側ライナーを備える、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a helmet for correcting a cranial shape, as described above, which includes an inner liner that is removably disposed on at least a portion of the inner surface of the outer shell.
また、本発明の他の態様は、前記外側シェルの少なくとも左右いずれかの側頭部にスリットが設けられる、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a skull shape correction helmet as described above, in which a slit is provided on at least one of the left and right sides of the outer shell.
また、本発明の他の態様は、上記いずれかに記載の頭蓋形状矯正用ヘルメットに用いられるライナーであって、
前記ライナーは、少なくとも第1の発泡合成樹脂層と第2の発泡合成樹脂層とを含む、
頭蓋形状矯正用ヘルメット用ライナー、である。
Another aspect of the present invention is a liner for use in any of the above-described cranial shape correction helmets,
The liner includes at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.
It is a liner for a helmet that corrects the shape of the skull.
また、本発明の他の態様は、前記発泡合成樹脂層を構成する発泡樹脂が、ポリウレタン、ポリスチレン、ポリエチレン、ポリプロピレン、EVA架橋発泡体、PET樹脂発泡体、フェノールフォームから選択されるいずれかである、
上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。
In another aspect of the present invention, the foamed resin constituting the foamed synthetic resin layer is any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA crosslinked foam, PET resin foam, and phenol foam.
A liner for a skull shape correction helmet as described above.
また、本発明の他の態様は、前記ライナーを構成する発泡合成樹脂層が、接着層、熱融着および縫合のいずれかの手段を用いて貼り合せてなる、
上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。
In another aspect of the present invention, the foamed synthetic resin layer constituting the liner is bonded by any one of an adhesive layer, heat fusion and sewing.
A liner for a skull shape correction helmet as described above.
また、本発明の他の態様は、前記接着層が、EVA(エチレン酢酸ビニル)、熱可塑性ポリウレタン、熱硬化性ポリウレタン、ポリエステル、ポリアミド、ポリオレフィン、アクリル樹脂、ゴムからなる群より選択される一つまたはこれらの任意の組合せである、
上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。
In another aspect of the present invention, the adhesive layer is one selected from the group consisting of EVA (ethylene vinyl acetate), thermoplastic polyurethane, thermosetting polyurethane, polyester, polyamide, polyolefin, acrylic resin, and rubber, or any combination thereof.
A liner for a skull shape correction helmet as described above.
また、本発明の他の態様は、前記第1の発泡合成樹脂層が、前記第2の発泡合成樹脂層と異なる反発弾性である、上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー。 Another aspect of the present invention is a liner for a skull shape correction helmet as described above, in which the first foamed synthetic resin layer has a different resilience than the second foamed synthetic resin layer.
また、本発明の他の態様は、前記第1の発泡合成樹脂層が、前記第2の発泡合成樹脂層と比較して低反発弾性である、上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。 Another aspect of the present invention is a liner for a skull shape correction helmet, as described above, in which the first foamed synthetic resin layer has a lower resilience than the second foamed synthetic resin layer.
また、本発明の他の態様は、前記第1の発泡合成樹脂層と前記第2の発泡合成樹脂層との厚さが異なる、上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。 Another aspect of the present invention is a liner for a skull shape correction helmet, as described above, in which the first foamed synthetic resin layer and the second foamed synthetic resin layer have different thicknesses.
また、本発明の他の態様は、前記第1の発泡合成樹層が、前記第2の発泡合成層よりも厚い、
上記いずれかに記載の頭蓋形状矯正用ヘルメット用ライナー、である。
In another aspect of the present invention, the first foamed synthetic layer is thicker than the second foamed synthetic layer.
A liner for a skull shape correction helmet as described above.
また、本発明の他の態様は、頭蓋部分を覆うように構成された外側シェルと、
少なくとも第1の発泡合成樹脂層と第2の発泡合成樹脂層とを含むライナーと、
を備える頭蓋形状矯正用ヘルメット、である。
Another aspect of the present invention is a surgical mask that includes an outer shell configured to cover a skull portion,
a liner including at least a first foamed synthetic resin layer and a second foamed synthetic resin layer;
A helmet for correcting a skull shape comprising:
また、本発明の他の態様は、左右側頭部の少なくとも片側にスリットが形成されてなり、
前記スリットを挟んで両側に連結用部材が設けられている、頭蓋形状矯正用ヘルメットの硬質外側シェルにおいて、
前記少なくとも1つの連結用部材に突出部を備える、
上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。
In another embodiment of the present invention, a slit is formed on at least one side of the left or right side of the head,
In the hard outer shell of a skull shape correction helmet, connecting members are provided on both sides of the slit,
The at least one connecting member is provided with a protrusion.
A helmet for correcting cranial shape as described above.
また、本発明の他の態様は、左右側頭部の少なくとも片側にスリットが形成されてなり、
前記スリットを挟んで両側に連結用部材が設けられている、頭蓋形状矯正用ヘルメットの硬質外側シェルにおいて、
前記少なくとも1つの連結用部材に突出部を備え、
前記突出部への係止部を備える固定用バンドを含む、
上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。
In another embodiment of the present invention, a slit is formed on at least one side of the left or right side of the head,
In the hard outer shell of a skull shape correction helmet, connecting members are provided on both sides of the slit,
The at least one connecting member includes a protrusion;
A fixing band having a locking portion for the protrusion is included.
A helmet for correcting cranial shape as described above.
また、本発明の他の態様は、前記突出部が前記少なくとも1つの連結用部材の対象位置から突出している少なくとも2つの突出部を備える、
上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。
In another aspect of the present invention, the protrusion includes at least two protrusions protruding from a target position of the at least one connecting member.
A helmet for correcting cranial shape as described above.
また、本発明の他の態様は、前記突出部が先端部方向に従い細くなる形状である、上記いずれかに記載の頭蓋形状矯正用ヘルメット、である。 Another aspect of the present invention is a helmet for correcting cranial shape described above, in which the protrusion is tapered toward the tip.
また、本発明の他の態様は、前記係止部が固定用バンドの少なくとも一端を長さ方向に折返してなる輪である、上記いずれかに記載の、
頭蓋形状矯正ヘルメット、である。
In addition, another aspect of the present invention is the above-mentioned, wherein the locking portion is a ring formed by folding back at least one end of the fixing band in the length direction.
It is a skull correction helmet.
また、本発明の他の態様は、前記固定用バンドの係止部で係止する連結用部材の反対側に位置する連結用部材で折り返して、固定する、
上記いずれかに記載の頭蓋形状矯正ヘルメット、である。
In another aspect of the present invention, the fixing band is folded back and fixed by a connecting member located on the opposite side of the connecting member that is engaged by the engaging portion of the fixing band.
A cranial shape correction helmet as described above.
また、本発明の他の態様は、前記固定用バンドの幅が、前記連結用孔の、バンドの長手方向に対して垂直幅方向と同じであるかやや短い、上記いずれかに記載の頭蓋形状矯正ヘルメット、である。 Another aspect of the present invention is a cranial shape correction helmet as described above, in which the width of the fixing band is the same as or slightly shorter than the width of the connecting hole in the direction perpendicular to the longitudinal direction of the band.
本発明に係る頭蓋形状矯正用ヘルメットによれば、ヘルメットの表面上に効率的に通気用貫通孔面積を確保することができ、頭皮環境を良好に保つことができる。また、通気用貫通孔の大きさを規則的にすることで、外部から頭部の歪みを目視あるいは通気用貫通孔に定規等を挿入することで、容易に確認することができる。 The skull shape correction helmet of the present invention can efficiently secure a large area of ventilation through-holes on the surface of the helmet, and can maintain a good scalp environment. In addition, by making the ventilation through-holes of regular size, distortion of the head can be easily confirmed from the outside by visual inspection or by inserting a ruler or the like into the ventilation through-hole.
本発明に係る頭蓋形状矯正ヘルメットによれば、治療に相応しい素材の内側ライナーを用いて、簡単な構成により、ヘルメット、具体的には後述するその外側シェルの内表面と、治療対象となる形状を有する頭蓋部分との間の摩擦係数を大きくすることが可能となる。このことにより、ヘルメットを被嵌した乳幼児の体の動きによる、頭蓋部分とヘルメットとの位置関係を適切に保つ、即ちこれらの間のずれを抑制することが可能となる。このことにより、結果的に、意図せずに頭蓋形状矯正ヘルメットが頭蓋部分から外れることを防止することができる。本発明のライナーは、低反発弾性の材料を使用しているため、乳幼児の頭蓋部分への負担を軽減できる。また、本発明に係る頭蓋形状矯正ヘルメットは、ヘルメット本体とライナーとを、面ファスナー部材により接合させることで、ライナーを、容易に着脱可能とする。このことから、治療の進捗に応じて、該部材を適宜取り外して形状を変更することが可能となり、効果的な治療を行うことが可能となる。 The cranial shape correction helmet of the present invention uses an inner liner made of a material suitable for treatment, and with a simple configuration, it is possible to increase the coefficient of friction between the helmet, specifically the inner surface of its outer shell described below, and the skull part having the shape to be treated. This makes it possible to properly maintain the positional relationship between the skull part and the helmet, that is, to suppress the displacement between them due to the body movement of the infant wearing the helmet. As a result, it is possible to prevent the cranial shape correction helmet from being unintentionally removed from the skull part. Since the liner of the present invention uses a low-resilience elastic material, it is possible to reduce the burden on the skull part of the infant. In addition, the cranial shape correction helmet of the present invention makes the liner easily removable by joining the helmet body and the liner with a hook-and-loop fastener member. This makes it possible to change the shape by appropriately removing the member according to the progress of treatment, making it possible to perform effective treatment.
また、構成の従来の固定用バンドと連結用部材を本発明のものとすることにより、脱着時に固定用バンドを硬質シェルから外す操作を容易にすることに加えて、固定用バンドの構成も簡素化できるため、装着時だけでなく管理上も好適な頭蓋形状矯正ヘルメットを提供することが可能となった。 In addition, by using the conventional fixing band and connecting member of the present invention, it is not only easier to remove the fixing band from the hard shell when putting on or taking off the helmet, but the structure of the fixing band can also be simplified, making it possible to provide a cranial shape correction helmet that is convenient not only when worn but also when it comes to maintenance.
本発明において、頭蓋形状矯正ヘルメットを構成する硬質のシェルは、本明細書において「合成樹脂製であり、3Dプリンタにより製造することができる。本発明の頭蓋形状矯正ヘルメットの目的から、個々の患者の頭部に合わせたヘルメットを製造するために、頭部形状の情報を画像認識アプリケーションなどで取得したのちに、目標形状に合わせたヘルメットを製造することから、3Dプリンタで個別に製造することが好ましい。3Dプリンタによる製造方法は適宜選択可能である。このような製造方法としては、材料押出堆積法(Material Extrusion)、液槽光重合法(Vat Polymerization)、粉末床融解結合法(Powder Bed Fusion)、特に粉末焼結積層造形法(selective laser sintering)、材料噴射法(Material Jetting)、結合剤噴射法(Binder Jetting・Binder Jetting)、指向性エネルギー堆積法(Direct Energy Deposition)、シート積層法(Sheet Lamination)があるが、これらに限定されない。 In the present invention, the hard shell constituting the cranial shape correction helmet is herein defined as "made of synthetic resin and can be manufactured by a 3D printer. In view of the purpose of the cranial shape correction helmet of the present invention, in order to manufacture a helmet that is tailored to the head of an individual patient, it is preferable to manufacture the helmet individually using a 3D printer, since head shape information is obtained using an image recognition application or the like and then the helmet is manufactured to match the target shape. The manufacturing method using a 3D printer can be appropriately selected. Such manufacturing methods include, but are not limited to, Material Extrusion, Vat Polymerization, Powder Bed Fusion, particularly selective laser sintering, Material Jetting, Binder Jetting, Direct Energy Deposition, and Sheet Lamination.
本明細書中に記載の「外側シェル」は、その内表面側の少なくとも一部に面ファスナー部材を備えることが可能なものである限り、材質等は特段限定されるものではない。外側シェルは、例えば、合成樹脂製であってもよい。合成樹脂としては、これらに限定されるものではないが、例えば、ポリアミド(ナイロン)、ポリカーボネイト、ポリエステル、ポリアセタール、ポリエチレン、ポリプロピレン、ポリ塩化ビニル、ポリスチレン、ポリブチレン、ABS樹脂、セルロース系樹脂、アクリル樹脂、エポキシ樹脂、フッ素樹脂の等が挙げられる。外側シェルは、粉末焼結積層造形法による成形の容易さや、強度及び硬度の点から、ポリアミド、特にポリアミド12が好ましい。また成型後の外側シェル100のショアD硬度は、例えば約70~約85、特には約75~約80であることが好ましい。 The "outer shell" described in this specification is not particularly limited in terms of material, etc., so long as it is capable of being provided with a hook-and-loop fastener member on at least a portion of its inner surface side. The outer shell may be made of, for example, a synthetic resin. Examples of synthetic resins include, but are not limited to, polyamide (nylon), polycarbonate, polyester, polyacetal, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polybutylene, ABS resin, cellulose-based resin, acrylic resin, epoxy resin, and fluororesin. In terms of ease of molding by powder sintering additive manufacturing, strength, and hardness, the outer shell is preferably made of polyamide, especially polyamide 12. In addition, the Shore D hardness of the outer shell 100 after molding is preferably, for example, about 70 to about 85, especially about 75 to about 80.
本発明の一実施態様では、外側シェルが、合成樹脂製(好ましくはポリアミド製、より好ましくはポリアミド12製)である。 In one embodiment of the invention, the outer shell is made of a synthetic resin (preferably polyamide, more preferably polyamide 12).
本発明の一実施態様において、外側シェルの内表面側の少なくとも一部に面ファスナー部材を設けることができる。このような面ファスナーは、後述する内側ライナーの貼着層に着脱可能に貼着できるものであれば、大きさ、形状、材質、位置等は特段限定されるものではない。面ファスナー部材の形状は、これらに限定されるものではないが、例えば、略三角形、略長方形、略正方形、略五角形、略六角形、略円形、略楕円形などが挙げられる。面ファスナー部材は、外側シェルの内表面の略全面に備えられていてもよいし、外側シェルの内表面の一部に設けられていてもよい。面ファスナー部材が外側シェルの内表面の一部に設けられる場合、面ファスナー部材は、例えば、前額部分に対応する位置、両側頭部に対応する位置、及び/又は後頭部に対応する位置に、それぞれ1つ又は複数(例えば、2~約10個)備えられていてもよい。 In one embodiment of the present invention, a hook-and-loop fastener member can be provided on at least a portion of the inner surface side of the outer shell. Such a hook-and-loop fastener is not particularly limited in size, shape, material, position, etc., as long as it can be removably attached to the adhesive layer of the inner liner described later. The shape of the hook-and-loop fastener member is not limited to these, but examples include an approximately triangular, approximately rectangular, approximately square, approximately pentagonal, approximately hexagonal, approximately circular, and approximately elliptical shape. The hook-and-loop fastener member may be provided on approximately the entire inner surface of the outer shell, or may be provided on a portion of the inner surface of the outer shell. When the hook-and-loop fastener member is provided on a portion of the inner surface of the outer shell, one or more hook-and-loop fastener members (e.g., 2 to about 10) may be provided, for example, at a position corresponding to the forehead, positions corresponding to both sides of the head, and/or positions corresponding to the back of the head.
外側シェルは、前側シェルと後側シェルとの間に、スリットを設けてもよい。これにより、頭蓋部分の成長に応じてスリットを適宜開き、前側シェルと後側シェルとの位置関係の調整が容易となる。スリットは、両側頭部の上縁から下縁まで延伸されていてもよい。これにより、外側シェルは、前側シェルと後側シェルとに分割可能としてもよい。 The outer shell may have a slit between the front and rear shells. This allows the slit to be opened appropriately in accordance with the growth of the skull, making it easy to adjust the relative positions of the front and rear shells. The slit may extend from the upper edge to the lower edge of both sides of the head. This allows the outer shell to be separated into a front shell and a rear shell.
本発明の一実施態様では、外側シェルの両側頭部にスリットが設けられる。本発明の好ましい実施態様では、スリットが両側頭部の上縁から下縁まで延伸されることにより、前記外側シェルが前側シェル及び後側シェルに分割されてなる。 In one embodiment of the present invention, slits are provided on both sides of the head of the outer shell. In a preferred embodiment of the present invention, the slits extend from the upper edge to the lower edge of both sides of the head, dividing the outer shell into a front shell and a rear shell.
外側シェルの表面は、メッシュ構造であってもよいし、複数の通気孔が設けられていてもよい。これにより、頭蓋形状矯正ヘルメット内外間の通気性が良好となり、治療対象の乳児の汗の放散や、頭蓋形状矯正ヘルメット内部で発生する熱の放熱などの点で有利な効果が期待できる。外側シェルがメッシュ構造である場合、面ファスナー部材が接着する部分においては、他の部分(即ち、面ファスナー部材が接着しない部分)よりもメッシュを細かくするか、メッシュを埋めてもよい。このようにすることで、外側シェルと面ファスナー部材との接触面積が増えるため、面ファスナー部材をより強固に接着することが可能となる。 The surface of the outer shell may have a mesh structure or may have multiple ventilation holes. This allows for good ventilation between the inside and outside of the cranial shape correction helmet, which is expected to have advantageous effects in terms of dissipating sweat from the infant being treated and dissipating heat generated inside the cranial shape correction helmet. If the outer shell has a mesh structure, the mesh in the area where the hook-and-loop fastener member is attached may be finer than in other areas (i.e., areas where the hook-and-loop fastener member is not attached), or the mesh may be filled in. This increases the contact area between the outer shell and the hook-and-loop fastener member, allowing the hook-and-loop fastener member to be attached more firmly.
本発明の一実施態様では、外側シェルが、メッシュ構造である。あるいは、外側シェルのメッシュの網目は適宜変更することができる。医師はヘルメットの内側と矯正する頭部との距離をメッシュの網目の穴から指やペン、定規などを挿入して頭蓋の成長を確認することがある。このため、左右の後頭部の少なくとも一部分の網目を大きくすることで医師の診察を容易にすることができる。 In one embodiment of the present invention, the outer shell has a mesh structure. Alternatively, the mesh size of the outer shell can be changed as appropriate. A doctor may check the distance between the inside of the helmet and the head to be corrected by inserting a finger, pen, ruler, etc. through holes in the mesh to check the growth of the skull. For this reason, enlarging the mesh in at least a portion of the left and right back of the head can make the doctor's examination easier.
外側シェルは、その周縁部が周縁補強部により補強されていてもよい。周縁補強部は、外側シェルのその他の部分(周縁補強部を除く部分)の厚さよりも、厚く構成されていてもよい。周縁補強部の横断面形状は、特段限定されるものではないが、例えば、直径約4~約8mm程度の略円形である所謂円形縁取りであってもよい。この場合、外側シェルの周縁補強部を除く部分の厚さは、例えば、約2~約4mm程度であってもよい。周縁補強部は、例えば、登頂開口部を規定している略円形の上縁と共に前側シェルの周辺部及び後側シェルの周辺部において肉厚を増大せしめた部分であってもよい。 The outer shell may have its peripheral portion reinforced by a peripheral reinforcement portion. The peripheral reinforcement portion may be configured to be thicker than the remaining portion of the outer shell (portion excluding the peripheral reinforcement portion). The cross-sectional shape of the peripheral reinforcement portion is not particularly limited, but may be, for example, a so-called circular border that is approximately circular with a diameter of about 4 to about 8 mm. In this case, the thickness of the portion of the outer shell excluding the peripheral reinforcement portion may be, for example, about 2 to about 4 mm. The peripheral reinforcement portion may be, for example, a portion where the thickness is increased in the peripheral portion of the front shell and the peripheral portion of the rear shell together with the approximately circular upper edge that defines the summit opening.
本発明の一実施態様では、外側シェルの周縁部の厚みが、他の部分の厚みより厚く構成される。 In one embodiment of the present invention, the thickness of the peripheral portion of the outer shell is greater than the thickness of the other portions.
外側シェルの前方両側面には、鉛直方向に一対の補強部が設けられていてもよい。補強部が設けられることで、その結果として構成される湾曲部分に乳児の耳が挿入されて、頭蓋形状矯正ヘルメットと頭蓋部分との位置関係が概ね固定することが可能となる。このように構成することにより、ヘルメットと頭蓋部分との位置関係は、より安定しうる。また、頭蓋形状矯正ヘルメットと頭蓋部分との間の押圧力を更に高めて、両者の位置関係をより安定させるために、外側シェルの内表面から頭蓋部分に向けて突出する、肉厚化部材(アタッチメント等)を、外側シェルの内表面に、部分的に更に設けても良い。 A pair of reinforcing parts may be provided vertically on both front side surfaces of the outer shell. By providing the reinforcing parts, the baby's ears can be inserted into the resulting curved parts, making it possible to generally fix the positional relationship between the cranial shape correction helmet and the skull part. This configuration can make the positional relationship between the helmet and the skull part more stable. In addition, to further increase the pressing force between the cranial shape correction helmet and the skull part and make the positional relationship between the two more stable, a thickened member (attachment, etc.) that protrudes from the inner surface of the outer shell toward the skull part may be partially provided on the inner surface of the outer shell.
本発明の一実施態様では、外側シェルの前方両側面には、鉛直方向に一対の補強部を更に有する。 In one embodiment of the present invention, the outer shell further has a pair of reinforcing parts in the vertical direction on both front side surfaces.
また本発明の頭蓋形状矯正ヘルメットは前側シェルと後側シェルから構成されており、これらのシェルは上記で説明するスリットと、連結用部材に面ファスナーなどから構成される固定用バンドを用いて結合して固定することができる。この連結用部材は、シェルの平均厚みよりも厚く構成しておくことで、メッシュ構造の中でしっかりと固定する部分が確保され、シェル全体の形状歪みを抑制することができる。 The skull shape correction helmet of the present invention is composed of a front shell and a rear shell, and these shells can be joined and fixed using the slits described above and a fixing band made of a hook-and-loop fastener or the like on the connecting member. By configuring this connecting member to be thicker than the average thickness of the shell, a part that is firmly fixed within the mesh structure is secured, and shape distortion of the entire shell can be suppressed.
本発明の一実施態様において、連結用部材は楕円状の長辺直径両端から少なくとも2ヵ所突出部を備える。連結用部材の形状は特に重要ではなく、対象となる両端から突出部材を構成することができればよい。そのため、連結用部材は、連結部材孔を備えることが好ましい。本発明において、後述する固定用バンドの係止部の幅と、連結用孔の幅を調整することで、固定用バンドの装着を容易にすることができる。 In one embodiment of the present invention, the connecting member has at least two protruding parts from both ends of the long side diameter of the ellipse. The shape of the connecting member is not particularly important as long as it is possible to form a protruding member from both ends in question. Therefore, it is preferable that the connecting member has a connecting member hole. In the present invention, the attachment of the fixing band can be made easier by adjusting the width of the engaging part of the fixing band described below and the width of the connecting hole.
本発明の蓋形状矯正ヘルメットに用いるライナーは、第1の発泡合成樹脂層と第2の発泡合成樹脂層とを接着層にて貼り合わせてなる。このような発泡合成樹脂の例としては、ポリウレタン、ポリスチレン、ポリエチレン、ポリプロピレン、EVA架橋発泡体、PET樹脂発泡体、フェノールフォームから選択されるいずれかであることが好ましく。加工性および価格の観点からポリウレタン樹脂が特に好ましい。 The liner used in the lid shape correction helmet of the present invention is formed by bonding a first foamed synthetic resin layer and a second foamed synthetic resin layer with an adhesive layer. Examples of such foamed synthetic resins are preferably any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA cross-linked foam, PET resin foam, and phenol foam. Polyurethane resin is particularly preferred from the viewpoints of processability and cost.
次に本発明の一実施形態として、前記発泡合成樹脂層がポリウレタンである場合の態様について説明する。第1のポリウレタン層は、ヘルメットを装着したときに頭部側になる層である。第1のポリウレタン層は、高密度を有する軟質ポリウレタン層であり、第2のポリウレタン層と貼着層を介して接着可能である限り、特段限定されるものではない。ライナーは、第1のポリウレタン層と第2のポリウレタン層のみであってもよいし、これらの間にそれ以外の層を含んでいてもよい。ライナーは、外側シェルと乳幼児の頭蓋の大きさ等を考慮し、所望の厚さとすることができる。ライナーは、1つの部材であってもよいし、複数部材であってもよい。ライナーは、交換の容易性(例えば、汗等で汚れた部分のみを交換できるように)の観点から、複数部材(例えば、2~約10個の部材、好ましくは2~約6個の部材)であることが好ましい。 Next, as one embodiment of the present invention, an embodiment in which the foamed synthetic resin layer is polyurethane will be described. The first polyurethane layer is the layer that faces the head when the helmet is worn. The first polyurethane layer is a soft polyurethane layer having a high density, and is not particularly limited as long as it can be adhered to the second polyurethane layer via an adhesive layer. The liner may be only the first polyurethane layer and the second polyurethane layer, or may include other layers between them. The liner can be of a desired thickness taking into consideration the size of the outer shell and the infant's skull, etc. The liner may be one member or multiple members. From the viewpoint of ease of replacement (e.g., so that only the parts soiled with sweat etc. can be replaced), it is preferable that the liner be multiple members (e.g., 2 to about 10 members, preferably 2 to about 6 members).
本明細書中に記載の第1のポリウレタン層は「軟質ポリウレタン層」でもよい。「軟質ポリウレタン層」とは、軟質ポリウレタンを主要な材料とする層である限り、特段限定されるものではない。軟質ポリウレタンとしては、これらに限定されるものではないが、ポリエステルフォーム、ポリエーテルフォームなどが挙げられるが、好ましくはポリエステルフォームである。軟質ポリウレタン層は、単層であってもよいし、複数の層(例えば、反発弾性や密度が異なる2種以上の軟質ポリウレタン層を組み合わせたもの)であってもよい。軟質ポリウレタン層の厚さは、本発明の目的を達成することができる限り特段限定されるものではないが、例えば、約1~約50mm、好ましくは約2~約40mm、より好ましくは約3~約30mm、さらに好ましくは約4~約20mmであってもよい。 The first polyurethane layer described in this specification may be a "soft polyurethane layer". The term "soft polyurethane layer" is not particularly limited as long as it is a layer whose main material is soft polyurethane. Examples of soft polyurethane include, but are not limited to, polyester foam and polyether foam, and preferably polyester foam. The soft polyurethane layer may be a single layer or multiple layers (for example, a combination of two or more types of soft polyurethane layers with different resilience and density). The thickness of the soft polyurethane layer is not particularly limited as long as the object of the present invention can be achieved, but may be, for example, about 1 to about 50 mm, preferably about 2 to about 40 mm, more preferably about 3 to about 30 mm, and even more preferably about 4 to about 20 mm.
本明細書中に記載の第1のポリウレタン層は、低反発弾性(反発弾性が、例えば約0~約50%(約50以下)、好ましくは約0~約40%(約40%以下)、より好ましくは約0~約30%(約30%以下))のものが好ましい。低反発弾性の軟質ポリウレタン層を用いることで、頭蓋部分と頭蓋形状矯正用ヘルメットとの位置関係を適切に保つことが可能となり、特にヘルメット治療開始直後の乳幼児において高い治療効果が期待できる。ここで、反発弾性とは、加えた力と跳ね返る力の比をパーセントで表した数値であり、例えば、反発弾性が100%とは、その材料におもりを落とした際におもりが元の位置(元の高さ)まで跳ね返ることを表し、逆に反発弾性が0%とは、少しも跳ね返らず、その場に静止することを表す。 The first polyurethane layer described in this specification is preferably low-resilience (resilience of, for example, about 0 to about 50% (about 50 or less), preferably about 0 to about 40% (about 40% or less), and more preferably about 0 to about 30% (about 30% or less)). By using a low-resilience soft polyurethane layer, it is possible to properly maintain the positional relationship between the skull and the skull shape correction helmet, and a high therapeutic effect can be expected, especially in infants and young children immediately after starting helmet treatment. Here, resilience is a numerical value that represents the ratio of the applied force to the rebound force, expressed as a percentage. For example, a resilience of 100% means that when a weight is dropped on the material, the weight will rebound to its original position (original height), and conversely, a resilience of 0% means that it does not rebound at all and remains stationary in place.
本明細書中に記載の第1のポリウレタン層は「高密度を有する軟質ポリウレタン層」とも表現できる。「高密度を有する軟質ポリウレタン層」とは、密度が0.05―0.5g/cm3であり反発弾性が20%~60%の軟質ポリウレタン層を意味する。高密度を有する軟質ポリウレタン層を使用することで、より高い治療効果が期待できる。 The first polyurethane layer described in this specification can also be expressed as a "soft polyurethane layer having a high density." A "soft polyurethane layer having a high density" refers to a soft polyurethane layer having a density of 0.05-0.5 g/cm3 and a rebound resilience of 20% to 60%. By using a soft polyurethane layer having a high density, a higher therapeutic effect can be expected.
これらの第1および第2発泡合成樹脂層は、接着層、熱融着または縫合等の好適な手段により貼り合せることができる。 The first and second foamed synthetic resin layers can be attached together by any suitable means, such as an adhesive layer, heat fusion or stitching.
本明細書中に記載の第2の発泡合成樹脂層はシェルの内側に設けられた面ファスナー部材の「貼着層」としても機能する。「貼着層」とは、少なくとも一方の面の少なくとも一部が、外側シェルの内表面に備えられた面ファスナー部材と着脱可能に接合できるものである限り、特段限定されるものではない。貼着層は、単層であってもよいし、複数の層であってもよい。貼着層は、これらに限定されるものではないが、例えば、ナイロン製のもの、面ファスナーのもの(例えば、外側シェルの内表面に備えられる面ファスナー部材が鈎形状を含むものであれば、ループ形状を含むもの、外側シェルの内表面に備えられる面ファスナー部材がループ形状を含むものであれば、鈎形状を含むもの)などが挙げられる。第2のポリウレタン層の厚さは、本発明の目的を達成することができる限り特段限定されるものではないが、例えば、約2~約20mmの間で適宜選択することができる。 The second foamed synthetic resin layer described in this specification also functions as an "adhesive layer" of the hook-and-loop fastener member provided on the inside of the shell. The "adhesive layer" is not particularly limited as long as at least a portion of at least one surface can be detachably joined to the hook-and-loop fastener member provided on the inner surface of the outer shell. The adhesive layer may be a single layer or multiple layers. The adhesive layer is not limited to these, but examples include nylon and hook-and-loop fasteners (e.g., if the hook-and-loop fastener member provided on the inner surface of the outer shell includes a hook shape, then a loop shape, and if the hook-and-loop fastener member provided on the inner surface of the outer shell includes a loop shape, then a hook shape). The thickness of the second polyurethane layer is not particularly limited as long as the object of the present invention can be achieved, but can be appropriately selected, for example, between about 2 and about 20 mm.
上記実施態様では、第1のポリウレタン層と第2のポリウレタン層は、接着層を介して貼り合わせられて、本発明のライナーを形成する。 In the above embodiment, the first polyurethane layer and the second polyurethane layer are bonded together via an adhesive layer to form the liner of the present invention.
本発明の一実施態様では、第1ポリウレタン層及び第2ポリウレタン層は、発泡ポリエステルフォームからなる。 In one embodiment of the present invention, the first polyurethane layer and the second polyurethane layer are made of expanded polyester foam.
本発明において、第1ポリウレタン層と第2ポリウレタン層とは、接着層を介して貼り合せてライナーを構成する。接着層は接着剤からなり、接着剤の例としては、EVA(エチレン酢酸ビニル)、熱可塑性ポリウレタン、熱硬化性ポリウレタン、ポリエステル、ポリアミド、ポリオレフィン、アクリル樹脂、ゴムからなる群より選択される一つまたはこれらの任意の組合せでよい。当業者は第1ポリウレタン層と第1ポリウレタン層の素材を考慮して好適な接着層を適宜選択することができる。 In the present invention, the first polyurethane layer and the second polyurethane layer are bonded together via an adhesive layer to form a liner. The adhesive layer is made of an adhesive, and examples of the adhesive may be one selected from the group consisting of EVA (ethylene vinyl acetate), thermoplastic polyurethane, thermosetting polyurethane, polyester, polyamide, polyolefin, acrylic resin, and rubber, or any combination of these. Those skilled in the art can appropriately select a suitable adhesive layer taking into account the materials of the first polyurethane layer and the second polyurethane layer.
本発明において、第1ポリウレタン層は第2ポリウレタン層よりも柔軟であることが好ましい。このように構成することで、シェルに触接接触するポリウレタン層が頭部を保護する役割を維持しつつ、頭部に直接触れるポリウレタン層は快適な装着環境を作ることができる。 In the present invention, it is preferable that the first polyurethane layer is softer than the second polyurethane layer. By configuring it in this way, the polyurethane layer that is in contact with the shell maintains its role of protecting the head, while the polyurethane layer that is in direct contact with the head can create a comfortable wearing environment.
第2ポリウレタン層はシェルの内側に設けられた面ファスナーと係合して強固に接合することが好ましい。面ファスナーへの接合だけを考慮すれば、第2ポリウレタン層は同じく面ファスナーとするか、表面が好適に起毛しているナイロン製布などで代用することも考えられる。しかしながら、本発明のライナーは乳児が長時間装着するものであり、清潔に保つことが好ましいため、水洗いが容易で乾燥の早いポリウレタン層を用いることが好ましい。 It is preferable that the second polyurethane layer engages with a hook-and-loop fastener provided on the inside of the shell and is firmly attached. If only the attachment to the hook-and-loop fastener is considered, the second polyurethane layer may be made of the same hook-and-loop fastener, or may be substituted with a nylon cloth with a suitably brushed surface. However, since the liner of the present invention is worn by infants for long periods of time and it is preferable to keep it clean, it is preferable to use a polyurethane layer that is easy to wash with water and dries quickly.
以下、図面を参照しつつ本明細書に記載の頭蓋形状矯正用ヘルメットの実施態様についてより詳細に説明するが、本発明を何ら限定することを意図するものではない。 The following describes in more detail the embodiments of the skull correction helmet described in this specification with reference to the drawings, but is not intended to limit the invention in any way.
図1は、本明細書中に記載の頭蓋形状矯正用ヘルメットの一実施態様を示す図である。図1に示す頭蓋形状矯正用ヘルメット1は、外側シェル10の内表面側に、装着者の頭蓋部分を覆うように、ライナー20が設けられている。ライナー20は、第1ポリウレタン層と、第2ポリウレタン層とを含む。この内側ライナー20が有する弾性および厚みにより、治療対象となる乳幼児の頭蓋部分の形状を徐々に矯正するものである。なお、図1では、内表面全体に内側ライナー20を設けているが、治療の方法、頭蓋部分の形状等を考慮して、必要と思われる部分のみに設けるようにしても良い。 FIG. 1 shows one embodiment of the skull correction helmet described in this specification. The skull correction helmet 1 shown in FIG. 1 has a liner 20 on the inner surface side of the outer shell 10 so as to cover the wearer's skull. The liner 20 includes a first polyurethane layer and a second polyurethane layer. The elasticity and thickness of this inner liner 20 gradually corrects the shape of the skull of the infant or child being treated. Note that while the inner liner 20 is provided on the entire inner surface in FIG. 1, it may be provided only in areas deemed necessary, taking into consideration the treatment method, the shape of the skull, etc.
頭蓋形状矯正用ヘルメットに用いられるライナーとしては、反発弾性があまり大きいものは、常に頭蓋に対してライナーからの反発力が作用していることとなり、乳幼児の頭蓋部分への負担が大きい。このようなことを考慮して、治療対象の乳幼児の負担を軽減しながら治療の効果も得られるように、低反発弾性(例えば、反発弾性が30%以下)のポリエステルフォームを用いることが好ましい。 If the liner used in a helmet for correcting skull shape has too much resilience, the repulsive force from the liner will always be acting on the skull, placing a large burden on the skull of infants and young children. Taking this into consideration, it is preferable to use polyester foam with low resilience (for example, resilience of 30% or less) so that the effects of treatment can be obtained while reducing the burden on the infant being treated.
また、低反発弾性のポリエステルフォームは、高反発弾性のものと比較して、頭蓋部分と面で接触した際に摩擦係数が大きく、従って相互に滑りにくい。このことから、ヘルメット内表面のクッションとして用いた場合には、頭蓋形状矯正用ヘルメットと頭蓋部分との位置関係がずれる更には意図せずに頭蓋形状矯正用ヘルメットが頭蓋部分から外れる、という問題が生じにくい。このようなことからも、図1に示す頭蓋形状矯正用ヘルメット1の外側シェル10の内表面に貼付される内側ライナー20の第1ポリウレタン層22としては、低反発弾性のポリエステルフォームを用いてもよい。 Furthermore, compared to high-resilience polyester foam, low-resilience polyester foam has a larger coefficient of friction when it comes into surface contact with the skull, and therefore is less likely to slip on each other. For this reason, when used as a cushion for the inner surface of a helmet, problems such as misalignment of the skull shape correction helmet and the skull part, or even the unintentional removal of the skull shape correction helmet from the skull part, are less likely to occur. For this reason, low-resilience polyester foam may be used as the first polyurethane layer 22 of the inner liner 20 that is affixed to the inner surface of the outer shell 10 of the skull shape correction helmet 1 shown in Figure 1.
内側ライナー20は、継続的な治療のためには、頭蓋形状矯正用ヘルメット1の外側シェル10の内表面に貼付されて、内表面から動かないことが望ましく、その点で、両面テープなどを用いて強固に貼付することが考えられる。しかしながら、頭蓋形状の矯正のための治療では、治療の経過や頭蓋部分の成長などによって、頭蓋形状矯正用ヘルメットの形状そのものを調整することも多く、頭蓋形状矯正用ヘルメット本体と内側ライナーとは着脱可能に構成されていることが望まれる。このようなことから、図1に示す頭蓋形状矯正用ヘルメット1では、内側ライナー20と外側シェル10内表面とを、面ファスナー部材40により圧着して、位置関係を固定している。面ファスナー部材40は、その表面全体が、素材そのものの微小な鈎形状で構成されていて、対向する表面の素材と係合することで、面同士が圧着される。
For continuous treatment, it is desirable that the inner liner 20 be attached to the inner surface of the outer shell 10 of the cranial shape correction helmet 1 and not move from the inner surface, and in this respect, it is considered to firmly attach it using double-sided tape or the like. However, in treatment for correcting cranial shape, the shape of the cranial shape correction helmet itself is often adjusted depending on the progress of treatment and the growth of the skull, and it is desirable that the cranial shape correction helmet body and the inner liner are configured to be detachable. For this reason, in the cranial shape correction helmet 1 shown in Figure 1, the inner liner 20 and the inner surface of the outer shell 10 are pressed together with a hook-and-
図1では、40a、40b、40c及び40dの4つの円形状の面ファスナー部材が使用され、それぞれ前額部、両側頭部及び後頭部に配置される。これら面ファスナー部材40は、一方の面が素材そのものの微小な鈎形状で構成された、いわゆる圧着面となっている。そして、内側ライナー20の表面には、後述する貼着層(ナイロンシート)22が備えられている。そのため、面ファスナー部材40は、このナイロンシート22を介して内側ライナー20と圧着している。面ファスナー部材40の他方の面は、外側シェル10の内表面に接着剤などで強固に固定される。ここで、面ファスナー部材としては、このような一方の面が圧着面となっている態様のものには限られず、後述するような、一対の対向する圧着面を有する面ファスナー片から成る面ファスナー部材を使用して、面ファスナー片のそれぞれを、内側ライナー20及び外側シェル10内表面に設けるようにしても良い。
In FIG. 1, four circular hook-and-loop fastener members 40a, 40b, 40c, and 40d are used, and are placed on the forehead, both sides of the head, and the back of the head, respectively. One side of each of these hook-and-
なお、外側シェル10の前方両側面には、鉛直方向に一対の補強部30が設けられている。補強部30が設けられることで、その結果として構成される湾曲部分に乳児の耳が挿入されて、頭蓋形状矯正用ヘルメット1と頭蓋部分との位置関係が概ね固定される構成となっている。このように構成することにより、ヘルメットと頭蓋部分との位置関係は、より安定する。また、頭蓋形状矯正用ヘルメット1と頭蓋部分との間の押圧力を更に高めて、両者の位置関係をより安定させるために、外側シェル10の内表面から頭蓋部分に向けて突出する、図示しないアタッチメントを、外側シェル10の内表面に、部分的に更に設けるようにしても良い。 A pair of reinforcing parts 30 are provided in the vertical direction on both front side surfaces of the outer shell 10. The provision of the reinforcing parts 30 allows the baby's ears to be inserted into the resulting curved parts, so that the positional relationship between the skull shape correction helmet 1 and the skull part is generally fixed. This configuration makes the positional relationship between the helmet and the skull part more stable. In addition, in order to further increase the pressing force between the skull shape correction helmet 1 and the skull part and make the positional relationship between the two more stable, an attachment (not shown) that protrudes from the inner surface of the outer shell 10 toward the skull part may be partially provided on the inner surface of the outer shell 10.
図2は、本発明の内側ライナー20の一実施態様を示す。ライナー20は第1ポリウレタン層22および第2ポリウレタン層が接着層23を介して結合している。図2において第1ポリウレタン層22が第2ポリウレタン層21より厚く構成されている。 Figure 2 shows one embodiment of the inner liner 20 of the present invention. The liner 20 is made up of a first polyurethane layer 22 and a second polyurethane layer bonded together via an adhesive layer 23. In Figure 2, the first polyurethane layer 22 is configured to be thicker than the second polyurethane layer 21.
図3は、面ファスナー部材40を介して内側ライナー20と頭蓋形状矯正用ヘルメット1の外側シェル10の内表面とを圧着させる際の状態を更に分かり易く示す斜視図である。面ファスナー部材40の表面のうち、他の素材の表面と係合可能なように、微小な鈎形状で表面全体が構成された圧着面41が、矢印A方向にナイロンシート21を介して、内側ライナー20の表面と係合して圧着する。また、他の表面42は、矢印B方向に、頭蓋形状矯正用ヘルメット1の外側シェル10内表面に接着剤などで固定される。このように構成することで、頭蓋形状矯正用ヘルメット1を治療対象の乳幼児に被嵌させている状態では、外側シェル10の内表面と内側ライナー20との間の摩擦係数は高く維持され、両者は滑りにくくなる。この結果、頭蓋形状矯正用ヘルメット1と頭蓋部分との間の位置関係のずれは抑制され、従って、意図せずに頭蓋形状矯正用ヘルメットが外れるという不具合も生じにくくなる。
3 is a perspective view showing in an even easier-to-understand manner the state when the inner liner 20 and the inner surface of the outer shell 10 of the skull correction helmet 1 are pressed together via the hook-and-
更に図4に示す実施態様では、外側シェル10の表面がデザイン性のあるメッシュ構造400となるよう構成されている。これにより、頭蓋形状矯正用ヘルメット内外間の通気性が良好となり、治療対象の乳児の汗の放散や、頭蓋形状矯正用ヘルメット内部で発生する熱の放熱などの点でも優れている。そして、メッシュ構造を採用しているため、使用する材料の使用量を削減でき、本体を軽量化でき、価格の低減も可能となる。また、メッシュ構造に材料の樹脂を成形することで、樹脂の配向が分散されるため、機械的な強度の点でも優れている。 Furthermore, in the embodiment shown in FIG. 4, the surface of the outer shell 10 is configured to have a stylish mesh structure 400. This allows for good ventilation between the inside and outside of the skull correction helmet, and is excellent in terms of dissipating sweat from the infant being treated and dissipating heat generated inside the skull correction helmet. Furthermore, the use of a mesh structure allows for a reduction in the amount of material used, making it possible to reduce the weight of the main body and lower the price. Furthermore, by molding the resin material into the mesh structure, the orientation of the resin is dispersed, resulting in excellent mechanical strength.
また、シェル外装のデザインは適宜変更することができ、本実施態様においては後頭部の一部に比較的大きな目の部分を設けることにより医師が当該目から棒やペンなどを挿入して頭蓋の成長を確認することができる(図5)。 The design of the shell exterior can be modified as needed. In this embodiment, a relatively large eye is provided at the back of the head, allowing the doctor to insert a stick or pen into the eye to check the growth of the skull (Figure 5).
次に図6を参照して、本願発明に係る、頭蓋形状矯正用ヘルメットの更に別の実施態様を示す図である。この実施態様においては、外側シェル10の左右いずれか1方向の鉛直方向にスリット6が入っている。このように構成することで、シェル10の通気性に寄与するとともに、シェル本体のたわみにも寄与し、連結バンド(図示せず)の装着を容易にすることができる。次に、図6を参照して、頭蓋形状矯正用ヘルメットを下方より見て、本発明のライナーの装着状態を説明する。図においては、ライナーは一つ続きに記載されているが、前後左右の好適な位置で分割したライナーを用いることも本発明の範囲内である。 Next, referring to Figure 6, there is shown yet another embodiment of the skull shape correction helmet according to the present invention. In this embodiment, a slit 6 is provided in the vertical direction in either the left or right direction of the outer shell 10. This configuration contributes to the breathability of the shell 10 and also contributes to the deflection of the shell body, making it easier to attach the connecting band (not shown). Next, referring to Figure 6, the skull shape correction helmet is viewed from below to explain the attached state of the liner of the present invention. In the figure, the liner is depicted as one continuous piece, but it is also within the scope of the present invention to use liners that are divided at suitable positions in the front, back, left, and right directions.
図7は、本願発明に係る頭蓋形状矯正用ヘルメットの一実施態様を示す図である。図1に示す頭蓋形状矯正用ヘルメット100は、外側シェル10の表面に、通気用貫通孔3が設けられている。図1において、ひし形の孔が規則的に設けられているが、本発明における通気用貫通孔の形状はこれに限定されるものではない。また、本発明に係る本願発明に係る頭蓋形状矯正用ヘルメットは、内側に頭部との緩衝部分を設けることもでき、通常は発泡性合成樹脂からなる2mm〜20mm程度のライナーを備える。当該ライナーは頭蓋形状矯正用ヘルメット1に直接的あるいは間接的に取り付けることができ、取付け手段は本発明において重要ではない。図7において、一実施態様として頭蓋形状矯正用ヘルメット1に記載の内側に面ファスナーを設けるための取付け部3を記載する。
Fig. 7 is a diagram showing one embodiment of the skull shape correction helmet according to the present invention. The skull shape correction helmet 100 shown in Fig. 1 has ventilation through
次に図8を参照して、本発明の頭蓋形状矯正ヘルメット1に設けられる通気用貫通孔4について説明する。図8において、通気用貫通孔3a〜3gは頭蓋形状矯正ヘルメット1上に規則的に配置されている。図8において、中央部から上下垂直方向に暫時面積を減少させて構成されている。このように構成することで、ヘルメット表面において、効率的に通気孔面積を確保しつつ、襟足および頭頂部を補強において、樹脂密度を高くすることで補強をすることも可能となる。 Next, referring to Figure 8, the ventilation through holes 4 provided in the cranial shape correction helmet 1 of the present invention will be described. In Figure 8, the ventilation through holes 3a-3g are regularly arranged on the cranial shape correction helmet 1. In Figure 8, the area is gradually reduced vertically from the center. With this configuration, it is possible to efficiently ensure the ventilation area on the helmet surface, while also reinforcing the nape and top of the head by increasing the resin density.
また、図8において、通気用貫通孔3a〜3gは水平方向に同じ列を並べ、ヘルメット全体として、通気用貫通孔3a〜3gを左右対称に配置することができる。このように構成することにより、例えば中央から同じ距離の穴から、診断用の定規等を挿入することにより、患児の頭部との距離を確認することができる。一般的な斜頭の場合、右と左の後頭部の高さが異なることが多く、図8のように通気用貫通孔3a〜3gが配置されていることでこのような左右差が容易に確認できる。 In addition, in Figure 8, the ventilation holes 3a〜3g are arranged in the same horizontal row, and the ventilation holes 3a〜3g can be arranged symmetrically on the left and right sides of the helmet as a whole. With this configuration, it is possible to check the distance from the patient's head by inserting a diagnostic ruler or the like through holes that are the same distance from the center. In typical cases of plagiocephaly, the right and left occipital heights are often different, and by arranging the ventilation holes 3a〜3g as in Figure 8, such left-right differences can be easily checked.
次に図9〜12を参照して、本願発明の頭蓋形状矯正用ヘルメット100における他の構成を説明する。本願発明の頭蓋形状矯正用ヘルメット100は図7および図8にて説明した構成のほか、略球状のヘルメット形状から、登頂開口部8と顔などが出る下部開口部9とからなり、側頭部にスリット6を構成し、スリット6の前後水平の位置に連結用部材5を配置してなる。なお、側頭部のスリットは図10のように片側のみでもよいし、両側にあってもよい。また、スリット6は単に、溝を構成するものでもよいし、後方端が前方端に(あるいはその逆)勘合するように構成してもよい。装着者の頭の発達具合によりスリットが適宜開くことで頭蓋の成長を妨げずに、連結部材の緩急で装着者の頭蓋に負担をかけずに変形を矯正することができる。 Next, referring to Figures 9-12, other configurations of the skull shape correction helmet 100 of the present invention will be described. In addition to the configurations described in Figures 7 and 8, the skull shape correction helmet 100 of the present invention has a substantially spherical helmet shape, a top opening 8 and a lower opening 9 through which the face and other parts come out, a slit 6 is formed on the side of the head, and a connecting member 5 is arranged in a horizontal position in front of and behind the slit 6. The slit on the side of the head may be on only one side as shown in Figure 10, or on both sides. The slit 6 may simply be a groove, or may be configured so that the rear end fits into the front end (or vice versa). By opening the slit appropriately according to the development of the wearer's head, the growth of the skull is not hindered, and the deformation can be corrected by adjusting the speed of the connecting member without putting a strain on the wearer's skull.
図9において、連結用部材5は楕円状の長辺直径両端から突出部が構成されている。連結用部材の形状は特に重要ではなく、固定用バンドA(図13)にて固定される形状および大きさがあればよい。 In Figure 9, the connecting member 5 has protrusions on both ends of the long side diameter of an ellipse. The shape of the connecting member is not particularly important, as long as it has a shape and size that allows it to be fixed with the fixing band A (Figure 13).
頭蓋形状矯正用ヘルメット100の前方両側面には、鉛直方向に一対の補強部7が設けられている。補強部7が設けられることで、その結果として構成される湾曲部分に乳児の耳が挿入されて、頭蓋形状矯正用ヘルメット1と頭蓋部分との位置関係を概ね固定することができる。 A pair of reinforcing parts 7 are provided in the vertical direction on both front sides of the skull shape correction helmet 100. By providing the reinforcing parts 7, the baby's ears can be inserted into the resulting curved part, and the positional relationship between the skull shape correction helmet 1 and the skull part can be roughly fixed.
次に、図13を参照して、本発明の頭蓋形状矯正ヘルメット100の更なる使用態様を説明する。図7において、頭蓋形状矯正ヘルメット100の内部には内側ライナー20を備える。内側ライナー20を係止するための内側ライナー接着部4は図7に示す。内側ライナー接着部4の一実施態様では面ファスナーで内側ライナーと接合させることができる。このように構成することで、頭部保護を目的とする内側ライナーの着脱を容易にすることができる。内側ライナー接着部4は、頭蓋形状矯正ヘルメット1の内側に複数個所つけることができる。本発明において、内側ライナーの接着手段を上記に限定することは意図しない。 Next, referring to FIG. 13, a further mode of use of the cranial shape correction helmet 100 of the present invention will be described. In FIG. 7, the interior of the cranial shape correction helmet 100 is provided with an inner liner 20. Inner liner adhesive part 4 for engaging the inner liner 20 is shown in FIG. 7. In one embodiment of the inner liner adhesive part 4, it can be attached to the inner liner with a hook-and-loop fastener. This configuration makes it easy to put on and take off the inner liner for the purpose of protecting the head. The inner liner adhesive part 4 can be attached in multiple places on the inside of the cranial shape correction helmet 1. It is not intended in the present invention to limit the adhesive means for the inner liner to the above.
内側ライナーの材質は、特段限定されるものではないが、例えば、発泡合成樹脂、好ましくは発泡ポリウレタン、発泡ナイロン、より好ましくは連続気孔発泡ポリウレタン(例えば、商品名「メモリーフォームCF-45」)などが挙げられる。 The material of the inner liner is not particularly limited, but examples include foamed synthetic resin, preferably foamed polyurethane, foamed nylon, and more preferably open-cell foamed polyurethane (for example, product name "Memory Foam CF-45").
内側ライナーの厚さは、これらに限定されるものではないが、例えば、約1~約50mm、好ましくは約3~約40mm、より好ましくは約5~約16mmである。また、内側ライナー200は、約15%以下のボール反発弾性を有するように構成してもよい。 The thickness of the inner liner is, but is not limited to, for example, about 1 to about 50 mm, preferably about 3 to about 40 mm, and more preferably about 5 to about 16 mm. The inner liner 200 may also be configured to have a ball resilience of about 15% or less.
また、内側ライナーに加え、肉厚化部材(図示せず)を前額部および/または後頸部および/または左右側頭部の所望の位置に設けることで、頭蓋形状矯正用ヘルメットの形状と患児の頭蓋形状とのずれをより抑制し、頭蓋形状矯正用ヘルメットの不要な振動をより抑制することができる。 Furthermore, by providing thickening members (not shown) in desired positions on the forehead and/or back of the neck and/or left and right sides of the head in addition to the inner liner, it is possible to further reduce deviations between the shape of the cranial shape correction helmet and the shape of the patient's skull, and to further reduce unnecessary vibrations of the cranial shape correction helmet.
本発明の頭蓋形状矯正用ヘルメット100に用いられる固定バンドAは、固定用部材5に係合しつつバンド同士を固定できるものであれば、いずれの素材および係止手段を用いてもよい。図13における実施態様においては、図1における連結用部材5の突出部に係合する輪を一方向に備え、折りたたんだ状態で対向する面がループ形状とフック部分で固定できる面ファスナーの構成を備えるものが好ましい。 The fixing band A used in the skull shape correction helmet 100 of the present invention may be made of any material and any fastening means as long as it can engage with the fixing member 5 and fasten the bands together. In the embodiment shown in FIG. 13, it is preferable that the fixing band A has a loop on one side that engages with the protruding part of the connecting member 5 in FIG. 1, and that the opposing surface in the folded state has a hook-and-loop fastener configuration that can be fastened with a loop shape and a hook portion.
次に図14を参照して、連結用部材5の構成を説明する。本実施態様では、連結用部材5は楕円状に構成されており、その長辺直径方向の相対する端部から突出部が連結用部材5の中心部に向けて構成されている(4Uおよび4D)。図14において、垂直方向上部の突出部を4Uおよび下側に構成されている突出部を4Dとする。本発明において、この突出部4Uおよび4Dに筒状の端部の係合部eを有する固定用バンドAの筒状部分を係合させ、硬質外側シェル10に固定用バンドを装着することができる。係合部eの幅は図14に示す連結部材孔55の高さ方向Hよりも0.5~1mm程度短く構成することが好ましい、また係合部eの筒の直径は連結部材孔55の幅Wよりも0.5~1mm程度短く構成することが好ましい。しかしながら、固定用バンドの部材により、脱着時の操作性がかわることから、このような条件に合わせて係合部eのサイズは適宜変更することができる。さらには、係合部eが好適に係合するように、突出部4U及び4Dの表面に摩擦力が生じやすいような部材あるは凸凹を構成してもよい。
Next, the configuration of the connecting member 5 will be described with reference to FIG. 14. In this embodiment, the connecting member 5 is configured in an elliptical shape, and protrusions are configured from the opposing ends in the long side diameter direction toward the center of the connecting member 5 (4U and 4D). In FIG. 14, the protrusion at the top in the vertical direction is 4U, and the protrusion configured on the lower side is 4D. In the present invention, the cylindrical portion of the fixing band A having the engagement portion e at the cylindrical end is engaged with the
次に、図15、16及び17を参照して、本発明における固定用バンドの一実施態様を説明する。図15は、固定用バンドの構成を説明する。本発明において、固定用バンドの端部fを、前述のように連結用部材5及び連結用部材孔55及び突出部4Uおよび4Dの大きさに応じて、好適な長さ文を点線aと合わせるように折り、縫い付けるなどして固定する。このように構成すると図17に記載のように係止部eは、筒状に構成され、これを適宜折り曲げて突出部4Uと4Dに係止することで固定用バンドAを硬質シェルに装着することができる。このときに、固定用バンドの幅hは、前述のように連結用部材孔55の高さHとサイズ調整を行った上で製造する。図17は固定用バンドAを厚さ方向から見た図である。図15に示すように、fをaに合わせて折り畳み縫い付けることで、輪が構成され係止部eが筒状となる。
Next, referring to Figures 15, 16 and 17, one embodiment of the fixing band of the present invention will be described. Figure 15 describes the configuration of the fixing band. In the present invention, the end f of the fixing band is folded to a suitable length according to the size of the connecting member 5, the connecting member hole 55 and the protruding
図15、16及び17においては、片側に係止部eをそなえる態様の固定バンドを例示している。図3Aにおいて、cのエリアと係止部eに面ファスナーを張り付けることで、連結用部材に固定バンドを通したあと、これらを面ファスナーで固定することができる。具体的には、固定バンドの対向する面の一方が微細なループ構造であり、もう一方が微細なフック構造を有していることから、個体バンドの係止部eを連結用部材の突出部に架けるようにして、一往復させるだけでループ構造とフック構造が係合して固定することができる。このように構成することで、固定用バンドAは3つの連結用部材の間を一往復してするだけで頭蓋形状矯正ヘルメットを固定することができる。 Figures 15, 16 and 17 show an example of a fixing band with a locking portion e on one side. In Figure 3A, by attaching a hook-and-loop fastener to area c and locking portion e, the fixing band can be passed through the connecting member and then fixed with the hook-and-loop fastener. Specifically, one of the opposing faces of the fixing band has a fine loop structure and the other has a fine hook structure, so that the locking portion e of the individual band is hung on the protruding portion of the connecting member and the band can be fixed by engaging the loop structure and hook structure with each other by simply moving it back and forth once. With this configuration, the fixing band A can fix the cranial shape correction helmet by simply moving it back and forth once between the three connecting members.
図18は、固定用バンドAが連結用部材5に係合しているところである。本実施態様では、固定用バンドAの幅が、連結用部材5の連結用孔55の高さ方向よりも少し短めに構成することにより、突出部4U及び4Dに引っ掛かる形で固定用バンド40が連結用孔に係止していることがわかる。
In Figure 18, the fixing band A is engaged with the connecting member 5. In this embodiment, the width of the fixing band A is slightly shorter than the height of the connecting hole 55 of the connecting member 5, so that the fixing
次に、図19及び20を参照して従来の固定用バンドについて説明する。図19には従来の固定用バンドを示す。従来の固定用バンドは、片面に雄もう片面に雌のループを備える面ファスナーのバンドに筒を通したものである。図20に示すように、連結用部材にこのバンドをとおして、折り返して筒に通し、さらに反対側の連結部材にとおして、最終的にバンドを一往復半連結用部材間に渡し、バンドを三重にして止めていた。このような構成の従来の固定用バンドを本発明のものとすることにより、脱着時に固定用バンドを硬質シェルから外す操作を容易にすることが可能となるだけでなく、固定用バンドの構成も簡素化できるため、装着時だけでなく管理上も好適な頭蓋形状矯正ヘルメットを提供することが可能となった。 Next, a conventional fixing band will be described with reference to Figures 19 and 20. Figure 19 shows a conventional fixing band. The conventional fixing band is a hook-and-loop fastener band with male loops on one side and female loops on the other side, with a tube passed through it. As shown in Figure 20, the band is passed through a connecting member, folded back and passed through the tube, and then passed through the connecting member on the other side, and finally the band is passed between the connecting members in one and a half round trips, and the band is secured in three layers. By adopting a conventional fixing band with such a configuration as the present invention, not only can it be easily removed from the hard shell when putting on or taking off the helmet, but the configuration of the fixing band can also be simplified, making it possible to provide a skull shape correction helmet that is convenient not only when putting on the helmet but also when managing it.
1、100:頭蓋形状矯正用ヘルメット
10:外側シェル
20:内側ライナー
21:第2ポリウレタン層
22:第1ポリウレタン層
23:接着層
40、40a、40b、40c、40d:面ファスナー部材
41、42:面ファスナー部材表面
400:メッシュ構造
30:補強部
3:通気用貫通孔
4:内側ライナー接着部(内側ライナー取り付け部)
5:連結用部材
55:連結部材孔
6:スリット
7:補強部
8:頭頂開口部
9:下部開口部
A:固定用バンド
11:周縁補強部
4U、4D:突出部
e:係止部
1, 100: Helmet for correcting skull shape 10: Outer shell 20: Inner liner 21: Second polyurethane layer 22: First polyurethane layer 23:
5: Connecting member 55: Connecting member hole 6: Slit 7: Reinforcement portion 8: Top opening 9: Lower opening A: Fixing band 11:
Claims (26)
請求項2または3に記載の頭蓋形状矯正用ヘルメット。 At least some of the opening areas of the plurality of ventilation through holes are arranged symmetrically in the up-down direction from the vertical center,
A helmet for correcting cranial shape according to claim 2 or 3.
前記ライナーは、少なくとも第1の発泡合成樹脂層と第2の発泡合成樹脂層とを含む、
頭蓋形状矯正用ヘルメット用ライナー。 A liner for use in the skull shape correction helmet according to claim 1,
The liner includes at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.
Helmet liner for corrective skull shape.
請求項11に記載の頭蓋形状矯正用ヘルメット用ライナー。 The foamed resin constituting the foamed synthetic resin layer is any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA crosslinked foam, PET resin foam, and phenol foam;
A liner for a cranial shape correction helmet as claimed in claim 11.
請求項11に記載の頭蓋形状矯正用ヘルメット用ライナー。 The foamed synthetic resin layer constituting the liner is bonded by any one of an adhesive layer, heat fusion and sewing.
A liner for a cranial shape correction helmet as claimed in claim 11.
請求項13に記載の頭蓋形状矯正用ヘルメット用ライナー。 The adhesive layer is one selected from the group consisting of EVA (ethylene vinyl acetate), thermoplastic polyurethane, thermosetting polyurethane, polyester, polyamide, polyolefin, acrylic resin, and rubber, or any combination thereof.
A liner for a cranial shape correction helmet as claimed in claim 13.
請求項11に記載の頭蓋形状矯正用ヘルメット用ライナー。 The first foamed synthetic layer is thicker than the second foamed synthetic layer;
A liner for a cranial shape correction helmet as claimed in claim 11.
少なくとも第1の発泡合成樹脂層と第2の発泡合成樹脂層とを含むライナーと、
を備える頭蓋形状矯正用ヘルメット。 an outer shell configured to cover a skull portion;
a liner including at least a first foamed synthetic resin layer and a second foamed synthetic resin layer;
A helmet for correcting a skull shape.
前記スリットを挟んで両側に連結用部材が設けられている、頭蓋形状矯正用ヘルメットの硬質外側シェルにおいて、
前記少なくとも1つの連結用部材に突出部を備える、
請求項1に記載の頭蓋形状矯正用ヘルメット。 A slit is formed on at least one side of the left or right side of the head,
In the hard outer shell of a skull shape correction helmet, connecting members are provided on both sides of the slit,
The at least one connecting member is provided with a protrusion.
A helmet for correcting a cranial shape according to claim 1.
前記スリットを挟んで両側に連結用部材が設けられている、頭蓋形状矯正用ヘルメットの硬質外側シェルにおいて、
前記少なくとも1つの連結用部材に突出部を備え、
前記突出部への係止部を備える固定用バンドを含む、
請求項1に記載の頭蓋形状矯正用ヘルメット。 A slit is formed on at least one side of the left or right side of the head,
In the hard outer shell of a skull shape correction helmet, connecting members are provided on both sides of the slit,
The at least one connecting member includes a protrusion;
A fixing band having a locking portion for the protrusion is included.
A helmet for correcting a cranial shape according to claim 1.
請求項20または21に記載の頭蓋形状矯正用ヘルメット。 The protrusion includes at least two protrusions protruding from a target location of the at least one connecting member.
A helmet for correcting a cranial shape according to claim 20 or 21.
請求項20または21に記載の頭蓋形状矯正用ヘルメット。 The protrusion has a shape that becomes thinner toward the tip end.
A helmet for correcting a cranial shape according to claim 20 or 21.
頭蓋形状矯正ヘルメット。 22. The method according to claim 21, wherein the locking portion is a loop formed by folding back at least one end of the fixing band in the length direction.
Cranial shape correction helmet.
請求項24に記載の頭蓋形状矯正ヘルメット。 The fixing band is folded back and fixed with a connecting member located on the opposite side of the connecting member that is engaged with the engaging portion of the fixing band.
25. The cranial shape correction helmet of claim 24.
The cranial shape correction helmet according to claim 20 or 21, wherein the width of the fixing band is the same as or slightly shorter than the width direction of the connecting hole perpendicular to the longitudinal direction of the band.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023-147222 | 2023-09-11 | ||
| JP2023147222A JP2025040343A (en) | 2023-09-11 | 2023-09-11 | Cranial shape correction helmet |
| JP2023187309A JP2025075862A (en) | 2023-10-31 | 2023-10-31 | Cranial shape correction helmet |
| JP2023-187309 | 2023-10-31 | ||
| JP2023187310A JP7751317B2 (en) | 2023-10-31 | 2023-10-31 | Cranial shape correction helmet |
| JP2023-187310 | 2023-10-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025057984A1 true WO2025057984A1 (en) | 2025-03-20 |
Family
ID=95021271
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/JP2024/032575 Pending WO2025057984A1 (en) | 2023-09-11 | 2024-09-11 | Cranial shape correction helmet |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025057984A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5094229A (en) * | 1991-02-11 | 1992-03-10 | Pomatto Jeanne K | Cranial remodeling orthosis |
| US20190015238A1 (en) * | 2015-09-08 | 2019-01-17 | Technology In Motion Ltd | Cranial Remoulding Orthosis And Method Of Manufacture Thereof |
| JP2022017025A (en) * | 2020-07-13 | 2022-01-25 | 株式会社ジャパン・メディカル・カンパニー | Cranial shape correction helmet |
| JP2023094208A (en) * | 2021-12-23 | 2023-07-05 | 株式会社Berry | Skull shape correcting helmet and method for manufacturing cranial shape correcting helmet |
-
2024
- 2024-09-11 WO PCT/JP2024/032575 patent/WO2025057984A1/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5094229A (en) * | 1991-02-11 | 1992-03-10 | Pomatto Jeanne K | Cranial remodeling orthosis |
| US20190015238A1 (en) * | 2015-09-08 | 2019-01-17 | Technology In Motion Ltd | Cranial Remoulding Orthosis And Method Of Manufacture Thereof |
| JP2022017025A (en) * | 2020-07-13 | 2022-01-25 | 株式会社ジャパン・メディカル・カンパニー | Cranial shape correction helmet |
| JP2023094208A (en) * | 2021-12-23 | 2023-07-05 | 株式会社Berry | Skull shape correcting helmet and method for manufacturing cranial shape correcting helmet |
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