Cranial shape correction helmet

Abstract

[Problem] To provide a cranial shape correction helmet which is capable of preventing the cranial shape correction helmet from being unintentionally detached from a cranial part even if a wearer is an infant who has just started helmet treatment. [Solution] A cranial shape correction helmet comprising: an outer shell configured to cover a cranial part; and a thickening member provided on at least a portion of the inner surface side of the outer shell and protruding in a direction toward the cranium of a wearer.

Description

Cranial shape correction helmet

[0001] The present invention relates to a cranial contouring helmet having a hard outer shell and a soft inner liner for use in correcting cranial deformities in infants.

[0002] Human infants, especially those over three months of age, may develop symptoms of cranial distortion, such as plagiocephaly, dolichocephaly, or brachycephaly. For example, in plagiocephaly, when viewed from above, the skull appears asymmetrical, tilted to one side. In dolichocephaly or brachycephaly, the skull is elongated or shortened in the anterior-posterior direction. If these conditions are left untreated and the distortion progresses, the position of the ears and the face become fixed in a deformed state.

[0003] For this reason, a treatment method (hereinafter also referred to as "helmet treatment") is sometimes adopted, in which a skull shape correction helmet, such as those exemplified in Patent Documents 1 and 2, is fitted to the infant's head and the infant lives daily in that state, depending on the symptoms. This treatment method makes it possible to gradually return the distorted skull shape to normal.

[0004] A cranial shape correction helmet is created to fit the skull of each infant being treated, taking into account the current shape of the skull and the expected shape after correction. In other words, a cranial shape correction helmet is made to order. Before creation, the skull of the infant being treated is scanned using a well-known three-dimensional scanning method to obtain detailed data on its shape. Then, based on the obtained data, the cranial shape correction helmet can be created using a 3D printer.

[0005] Patent No. 6833240 Patent No. 6333514

[0006] Helmet therapy is sometimes performed with a cranial shape correction helmet fitted to the skull of the infant being treated for most of the day (e.g., 20 hours or more per day), including while sleeping. Helmet therapy using the cranial shape correction helmets disclosed in Patent Documents 1 and 2 has been shown to have a certain degree of therapeutic effect.

[0007] Infants and toddlers between the ages of approximately 3 months and under 1 year, who are the primary patients for helmet therapy, have a smaller skull volume and a denser distribution of sweat glands compared to adults. Furthermore, their thermoregulatory functions are less developed than adults, so there is a natural concern that the skin environment may deteriorate due to sweating. Naturally, children undergoing helmet therapy wear synthetic resin helmets for long periods of time, which raises concerns about the skin environment. In particular, helmets that allow for quick release of sweat are preferred for helmet therapy, but there are no helmets that specifically address this issue.

[0008] Furthermore, while it is important to prevent the cranial shape correction helmet from slipping during helmet therapy, the inventors have discovered, based on their many years of experience developing cranial shape correction helmets, that whether the cranial shape correction helmet fits properly during the first few months of treatment can have a significant impact on the effectiveness and duration of treatment. Based on this finding, 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 for infants who have just started helmet therapy.

[0009] However, when the inventors attempted 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 discovered a new problem: the bond to the hook-and-loop fastener was extremely weak, or did not bond to the hook-and-loop fastener at all, causing the inner liner to shift position very easily, resulting in an unsatisfactory cranial shape correction helmet.

[0010] In addition, the inventors have discovered 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, so they need to be easy to operate when they slip off or when putting on.In light of this, they have discovered 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 central part of this straight member removed, i.e., by changing only the linear end of the generally circular shape to have a protrusion extending toward the center of the circle, and by forming a ring at the end of the fixing band so that it can be hooked onto the protrusion, it is possible to provide a cranial correction helmet that allows the fixing band to be made single-layered and makes it easy to put on and take off the band.

[0011] The present invention aims to provide a cranial orthodontic helmet that solves the above-mentioned problems.

[0012] The first aspect of the present invention, which is designed to solve the above-mentioned problems, 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.

[0013] Another aspect of the present invention is the above-described cranial shape corrective helmet, characterized in that, when the hard outer shell is attached, the hole area of ​​at least some of the multiple ventilation through holes varies upward and downward from the vertical center of the hard outer shell.

[0014] Another aspect of the present invention is the above-described cranial shape correcting helmet, wherein the hole area of ​​at least some of the plurality of ventilation through holes is largest at the vertical center and gradually decreases as the distance from the center increases.

[0015] Another aspect of the present invention is a cranial shape correction helmet as described above, wherein the opening areas of at least some of the plurality of ventilation through holes are arranged symmetrically in the up-down direction from the vertical center.

[0016] Another aspect of the present invention is a cranial shape correction helmet described in any of the above, in which the hole spacing of at least some of the multiple ventilation through holes is arranged symmetrically in the up and down direction from the vertical center.

[0017] Another aspect of the present invention is a cranial shape correction helmet as described above, in which the ventilation through-holes are arranged symmetrically, with the spacing between the ends of at least some of the holes gradually increasing in the up-down direction from the vertical center.

[0018] Another aspect of the present invention is a skull shape correction helmet as described above, in which at least some of the plurality of ventilation through-holes are arranged at equal intervals in an area corresponding to one or a combination of the frontal bone, parietal bone, and occipital bone.

[0019] Another aspect of the present invention is a cranial shape correction helmet as described above, wherein at least some of the plurality of ventilation through-holes have a hole area sufficient to allow insertion of a diagnostic tool.

[0020] Another aspect of the present invention is a skull shape correction helmet as described above, which includes an inner liner removably disposed on at least a portion of the inner surface of the outer shell.

[0021] Another aspect of the present invention is a cranial shape correction helmet as described above, wherein a slit is provided in at least one of the left and right temporal regions of the outer shell.

[0022] Another aspect of the present invention is a liner for a cranial shape correction helmet, which is used in any of the above-described cranial shape correction helmets, and which includes at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.

[0023] Another aspect of the present invention is a liner for a cranial shape corrective helmet described in any one of the above, wherein the foamed resin constituting the foamed synthetic resin layer is any one selected from polyurethane, polystyrene, polyethylene, polypropylene, EVA cross-linked foam, PET resin foam, and phenol foam.

[0024] Another aspect of the present invention is a liner for a cranial shape correction helmet described in any one of the above, wherein the foamed synthetic resin layer constituting the liner is bonded using any one of an adhesive layer, heat fusion, and stitching.

[0025] Another aspect of the present invention is a liner for a cranial shape correction helmet described in any one of the above, wherein 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.

[0026] Another aspect of the present invention is a liner for a cranial shape correction helmet described in any of the above, wherein the first foamed synthetic resin layer has a different rebound resilience than the second foamed synthetic resin layer.

[0027] Another aspect of the present invention is a liner for a cranial shape correction helmet described in any of the above, in which the first foamed synthetic resin layer has lower rebound resilience than the second foamed synthetic resin layer.

[0028] Another aspect of the present invention is a liner for a cranial shape correction helmet, as described in any one of the above, in which the first foamed synthetic resin layer and the second foamed synthetic resin layer have different thicknesses.

[0029] Another aspect of the present invention is a liner for a cranial shape correction helmet described in any one of the above, wherein the first foam synthetic layer is thicker than the second foam synthetic layer.

[0030] Another aspect of the present invention is a skull correction helmet comprising: an outer shell configured to cover a portion of the skull; and a liner including at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.

[0031] Another aspect of the present invention is a cranial shape correction helmet as described above, in which a hard outer shell of the cranial shape correction helmet has a slit formed on at least one side of the left or right temporal region, and connecting members are provided on both sides of the slit, and at least one of the connecting members is provided with a protrusion.

[0032] Another aspect of the present invention is a cranial shape correction helmet as described above, in which the hard outer shell of the cranial shape correction helmet has a slit formed on at least one side of the left or right temporal region, and connecting members are provided on both sides of the slit, and the at least one connecting member has a protrusion, and the helmet includes a fixing band having an engaging portion for engaging with the protrusion.

[0033] Another aspect of the present invention is a cranial shape correction helmet described in any of the above, wherein the protrusion comprises at least two protrusions protruding from the target position of the at least one connecting member.

[0034] Another aspect of the present invention is a skull shape correction helmet as described above, wherein the protrusion has a shape that tapers toward the tip.

[0035] Another aspect of the present invention is the cranial shape correcting helmet according to any one of the above, wherein the engaging portion is a ring formed by folding back at least one end of the fixing band in the lengthwise direction.

[0036] Another aspect of the present invention is a cranial shape corrective helmet described in any of the above, in which the helmet is folded over 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.

[0037] Another aspect of the present invention is a cranial shape correcting helmet described in any of the 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.

[0038] The skull shape correction helmet according to the present invention can efficiently secure an area of ​​ventilation through-holes on the surface of the helmet, thereby maintaining a good scalp environment. Furthermore, by making the ventilation through-holes of regular size, distortion of the head can be easily confirmed from the outside by visually checking or by inserting a ruler or the like into the ventilation through-holes.

[0039] 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 portion having the shape to be treated. This makes it possible to maintain the proper positional relationship between the skull portion and the helmet, i.e., to prevent misalignment due to the body movements of the infant wearing the helmet. As a result, it is possible to prevent the cranial shape correction helmet from unintentionally detaching from the skull portion. The liner of the present invention is made of a low-resilience material, which reduces the burden on the infant's skull portion. Furthermore, the cranial shape correction helmet of the present invention is easily detachable by joining the helmet body and the liner with a hook-and-loop fastener. This allows the helmet to be appropriately removed to change the shape as the treatment progresses, enabling effective treatment.

[0040] Furthermore, by replacing the conventional fixing band and connecting member with those of the present invention, it is not only easier to remove the fixing band from the hard shell when putting it on or taking it off, 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 in terms of maintenance.

[0041] FIG. 1 is a front view schematically illustrating the entire structure of one embodiment of a cranial shape correction helmet described herein. FIG. 2 is a diagram illustrating the configuration of a liner described herein. FIG. 3 is an exploded, partial perspective view showing the relationship between an inner liner used in a helmet described herein and a hook-and-loop fastener member. FIG. 4 is a perspective view showing another embodiment of a cranial shape correction helmet described herein. FIG. 5 is a rear view of the helmet shown in FIG. 4. FIG. 6 is a bottom view of the helmet shown in FIG. 4. FIG. 7 is a front view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 8 is a rear view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 9 is a right side view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 10 is a left side view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 11 is a top view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 12 is a bottom view of a cranial shape correction helmet according to another embodiment of the present invention. FIG. 13 is a view of a cranial shape correction helmet according to another embodiment of the present invention with a fixing band attached. *Figure 1 of P020 is omitted as it overlaps with Figure 9. **Figure 14 shows the connecting member and protrusion of a cranial shape corrective helmet constructed in accordance with the present invention. Figure 15 is a diagram explaining the fixing band of a cranial shape corrective helmet constructed in accordance with the present invention. Figure 16 is a diagram explaining the fixing band of a cranial shape corrective helmet constructed in accordance with the present invention. Figure 17 is a diagram explaining the fixing band of a cranial shape corrective helmet constructed in accordance with the present invention. Figure 18 is a diagram showing the use of the fixing band in a conventional cranial shape corrective helmet. Figure 19 is a diagram showing the fixing band in a conventional cranial shape corrective helmet. Figure 20 is a diagram showing an example of a conventional cranial shape corrective helmet with the fixing band attached.

[0042] In the present invention, the hard shell that constitutes the cranial shape correction helmet is referred to in this specification as "made of synthetic resin and can be manufactured using a 3D printer. In accordance with the purpose of the cranial shape correction helmet of the present invention, in order to manufacture a helmet that fits the head of an individual patient, head shape information is acquired using an image recognition application or the like, and then a helmet is manufactured that fits the target shape, so it is preferable to manufacture it individually using a 3D printer. The manufacturing method using a 3D printer can be selected as appropriate. Examples of such manufacturing methods include material extrusion, liquid vat polymerization, powder bed fusion, particularly selective laser sintering, material jetting, binder jetting, directed energy deposition, and sheet lamination, but are not limited to these.

[0043] The "outer shell" described herein is not particularly limited in terms of material, as long as it is capable of providing a hook-and-loop fastener on at least a portion of its inner surface. 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. The outer shell is preferably made of polyamide, particularly polyamide 12, in terms of ease of molding using powder sintering additive manufacturing, strength, and hardness. Furthermore, the Shore D hardness of the molded outer shell 100 is preferably, for example, about 70 to about 85, particularly about 75 to about 80.

[0044] In one embodiment of the invention, the outer shell is made of synthetic resin, preferably polyamide, more preferably polyamide 12.

[0045] 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 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 below. The shape of the hook-and-loop fastener member is not limited to these, but examples include a substantially triangular, substantially rectangular, substantially square, substantially pentagonal, substantially hexagonal, substantially circular, and substantially elliptical shape. The hook-and-loop fastener member may be provided on substantially the entire inner surface of the outer shell, or 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 at positions corresponding to the forehead, both sides of the head, and / or the back of the head, for example.

[0046] The outer shell may have a slit between the front shell and the rear shell. This allows the slit to be opened appropriately according to the growth of the skull, making it easy to adjust the positional relationship between the front shell and the rear shell. 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 the front shell and the rear shell.

[0047] 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, thereby dividing the outer shell into a front shell and a rear shell.

[0048] The surface of the outer shell may have a mesh structure or may have multiple ventilation holes. This improves 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 may be finer in the areas where the hook-and-loop fastener is attached than in other areas (i.e., areas where the hook-and-loop fastener is not attached), or the mesh may be embedded. This increases the contact area between the outer shell and the hook-and-loop fastener, allowing the hook-and-loop fastener to be attached more firmly.

[0049] 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 needed. Doctors may check the distance between the inside of the helmet and the head to be corrected by inserting a finger, pen, ruler, or the like through holes in the mesh to check the growth of the skull. Therefore, enlarging the mesh in at least a portion of the left and right occipital regions can facilitate the doctor's examination.

[0050] The outer shell may have a peripheral edge reinforced by a peripheral reinforcement. The peripheral reinforcement may be thicker than the remaining portions of the outer shell (portions excluding the peripheral reinforcement). The cross-sectional shape of the peripheral reinforcement is not particularly limited, but may be, for example, a so-called circular edging 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 may be, for example, about 2 to about 4 mm. The peripheral reinforcement may be, for example, a portion where the thickness is increased in the peripheral portions of the front shell and the rear shell, along with the approximately circular upper edge that defines the summit opening.

[0051] In one embodiment of the present invention, the thickness of the peripheral edge of the outer shell is configured to be thicker than the thickness of the remaining portion.

[0052] A pair of vertically extending reinforcing portions may be provided on both front side surfaces of the outer shell. The provision of the reinforcing portions allows the infant's ears to be inserted into the resulting curved portion, thereby generally fixing the positional relationship between the cranial shape correction helmet and the skull. This configuration can further stabilize the positional relationship between the helmet and the skull. Furthermore, to further increase the pressing force between the cranial shape correction helmet and the skull and further stabilize the positional relationship between them, thickened members (such as attachments) protruding from the inner surface of the outer shell toward the skull may be provided partially on the inner surface of the outer shell.

[0053] In one embodiment of the present invention, the outer shell further has a pair of vertically extending reinforcing portions on both front side surfaces thereof.

[0054] The cranial shape corrective 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 hook-and-loop fasteners or the like on the connecting member. By configuring this connecting member to be thicker than the average thickness of the shell, a secure fixing portion can be secured within the mesh structure, and shape distortion of the entire shell can be suppressed.

[0055] In one embodiment of the present invention, the connecting member has at least two protruding portions 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 can form protruding members from both ends. 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 locking portion of the fixing band (described later) and the width of the connecting hole.

[0056] The liner used in the lid shape corrective helmet of the present invention is formed by bonding a first foamed synthetic resin layer and a second foamed synthetic resin layer together with an adhesive layer. Examples of such foamed synthetic resins are preferably 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.

[0057] 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 with 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 consist of only the first and second polyurethane layers, or may include other layers between them. The liner can be of any desired thickness, taking into account factors such as the size of the outer shell and the infant's skull. The liner may be a single component or multiple components. From the perspective of ease of replacement (e.g., so that only the portion soiled by sweat or the like can be replaced), it is preferable for the liner to be multiple components (e.g., 2 to approximately 10 components, preferably 2 to approximately 6 components).

[0058] The first polyurethane layer described herein may be a "flexible polyurethane layer." The term "flexible polyurethane layer" is not particularly limited as long as it is a layer primarily made of flexible polyurethane. Flexible polyurethanes include, but are not limited to, polyester foam and polyether foam, with polyester foam being preferred. The flexible polyurethane layer may be a single layer or multiple layers (e.g., a combination of two or more flexible polyurethane layers with different impact resilience or density). The thickness of the flexible 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.

[0059] The first polyurethane layer described herein preferably has 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)). The use of a low-resilience soft polyurethane layer makes it possible to maintain an appropriate positional relationship between the skull and the cranial shape correction helmet, and is expected to provide a high therapeutic effect, particularly for infants immediately after the start of helmet therapy. Here, resilience is a numerical value expressed as a percentage of the ratio of the applied force to the rebound force. 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), while a resilience of 0% means that it does not rebound at all and remains stationary.

[0060] The first polyurethane layer described herein can also be described as a "high-density soft polyurethane layer." The "high-density soft polyurethane layer" refers to a soft polyurethane layer having a density of 0.05-0.5 g / cm and a rebound resilience of 20% to 60%. The use of a high-density soft polyurethane layer can be expected to provide a higher therapeutic effect.

[0061] The first and second foamed synthetic resin layers may be attached together by any suitable means such as adhesive, heat sealing or stitching.

[0062] The second foamed synthetic resin layer described herein also functions as an "adhesive layer" for the hook-and-loop fastener provided on the inside of the shell. The term "adhesive layer" is not particularly limited, as long as at least a portion of at least one surface can be detachably attached to the hook-and-loop fastener provided on the inner surface of the outer shell. The adhesive layer may be a single layer or multiple layers. Examples of adhesive layers include, but are not limited to, nylon and hook-and-loop fasteners (e.g., a loop-shaped adhesive layer if the hook-and-loop fastener provided on the inner surface of the outer shell is hook-shaped, and a loop-shaped adhesive layer if the hook-and-loop fastener provided on the inner surface of the outer shell is loop-shaped). The thickness of the second polyurethane layer is not particularly limited as long as the objectives of the present invention can be achieved, but may be appropriately selected, for example, between about 2 and about 20 mm.

[0063] In the above embodiment, the first polyurethane layer and the second polyurethane layer are attached together via an adhesive layer to form the liner of the present invention.

[0064] In one embodiment of the present invention, the first polyurethane layer and the second polyurethane layer comprise expanded polyester foam.

[0065] 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 include 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. Those skilled in the art can select a suitable adhesive layer taking into account the materials of the first polyurethane layer and the second polyurethane layer.

[0066] In the present invention, the first polyurethane layer is preferably softer than the second polyurethane layer, so that the polyurethane layer in direct contact with the head can create a comfortable wearing environment while the polyurethane layer in direct contact with the head can maintain its role of protecting the head.

[0067] The second polyurethane layer preferably 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 raised 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.

[0068] The embodiments of the cranial shape correction helmet described in this specification will be described in more detail below with reference to the drawings, but are not intended to limit the present invention in any way.

[0069] FIG. 1 shows one embodiment of the cranial shape correction helmet described herein. The cranial shape correction helmet 1 shown in FIG. 1 has a liner 20 attached to the inner surface of an 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 allow for gradual correction of the skull shape of the infant or young child being treated. While the inner liner 20 is shown attached to the entire inner surface in FIG. 1, it may be attached only to areas deemed necessary, taking into consideration the treatment method, skull shape, etc.

[0070] If the liner used in a skull correction helmet has too much resilience, the liner will always exert a repulsive force on the skull, placing a heavy burden on the skull of the infant. Taking this into consideration, it is preferable to use a polyester foam with low resilience (for example, a resilience of 30% or less) so that the effects of treatment can be obtained while reducing the burden on the infant being treated.

[0071] Furthermore, compared with high-resilience polyester foam, low-resilience polyester foam has a higher coefficient of friction when it comes into surface contact with the skull, making it less likely to slip relative to the skull. For this reason, when used as a cushion on the inner surface of a helmet, it is less likely to cause problems such as misalignment between the cranial shape correction helmet and the skull, or even the unintentional removal of the cranial shape correction helmet from the skull. For these reasons, low-resilience polyester foam may be used for the first polyurethane layer 22 of the inner liner 20 attached to the inner surface of the outer shell 10 of the cranial shape correction helmet 1 shown in Figure 1.

[0072] 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; therefore, it is conceivable to firmly attach it using double-sided tape or the like. However, in treatment for cranial shape correction, the shape of the cranial shape correction helmet itself is often adjusted depending on the progress of treatment and the growth of the skull, so it is desirable that the cranial shape correction helmet main body and the inner liner be 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 pressure-bonded together with a hook-and-loop fastener 40 to fix their relative positions. The entire surface of the hook-and-loop fastener 40 is composed of tiny hooks made of the material itself, which engage with the material on the opposing surface, thereby pressure-bonding the surfaces together.

[0073] In FIG. 1 , four circular hook-and-loop fastener members 40a, 40b, 40c, and 40d are used, and are positioned at 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-bonding surface, consisting of tiny hooks made of the material itself. An adhesive layer (nylon sheet) 22, which will be described later, is provided on the surface of the inner liner 20. Therefore, the hook-and-loop fastener members 40 are pressure-bonded to the inner liner 20 via this nylon sheet 22. The other side of each 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 a configuration in which one side is a pressure-bonding surface. It is also possible to use a hook-and-loop fastener member consisting of hook-and-loop fastener pieces having a pair of opposing pressure-bonding surfaces, as will be described later, with each hook-and-loop fastener piece being provided on the inner surface of the inner liner 20 and the outer shell 10.

[0074] A pair of reinforcing sections 30 are provided vertically on both front side surfaces of the outer shell 10. The provision of the reinforcing sections 30 allows the baby's ears to be inserted into the resulting curved sections, generally fixing the positional relationship between the cranial shape correction helmet 1 and the skull. This configuration further stabilizes the positional relationship between the helmet and the skull. Furthermore, to further increase the pressing force between the cranial shape correction helmet 1 and the skull and further stabilize the positional relationship between them, attachments (not shown) that protrude from the inner surface of the outer shell 10 toward the skull may be provided partially on the inner surface of the outer shell 10.

[0075] Figure 2 shows one embodiment of an inner liner 20 of the present invention. The liner 20 comprises 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 thicker than the second polyurethane layer 21.

[0076] FIG. 3 is a perspective view more clearly illustrating the state when the inner liner 20 and the inner surface of the outer shell 10 of the cranial shape correction helmet 1 are crimped together via the hook-and-loop fastener 40. The cranial shape correction helmet 1 is crimped together by a cranial shape correction surface 41, whose entire surface is composed of tiny hooks so that it can engage with the surface of another material. The cranial shape correction helmet 1 is crimped together by a cranial shape correction surface 41 in the direction of arrow A via the nylon sheet 21. The other surface 42 is fixed to the inner surface of the outer shell 10 of the cranial shape correction helmet 1 with an adhesive or the like in the direction of arrow B. This configuration maintains a high coefficient of friction between the inner surface of the outer shell 10 and the inner liner 20 when the cranial shape correction helmet 1 is fitted to the infant being treated, preventing slippage between the two. This reduces misalignment between the cranial shape correction helmet 1 and the skull, thereby reducing the risk of the cranial shape correction helmet being accidentally removed.

[0077] Furthermore, in the embodiment shown in Figure 4, the surface of the outer shell 10 is configured with a stylish mesh structure 400. This allows for good ventilation between the inside and outside of the cranial shape correction helmet, which is excellent in terms of dissipating sweat from the infant being treated and dissipating heat generated inside the cranial shape correction helmet. Furthermore, the mesh structure reduces the amount of material used, making the helmet lighter and less expensive. Furthermore, molding the resin material into the mesh structure distributes the orientation of the resin, resulting in excellent mechanical strength.

[0078] 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 a doctor to insert a stick or pen into the eye to check the growth of the skull (Figure 5).

[0079] Next, referring to Figure 6, a diagram showing yet another embodiment of the cranial shape correction helmet according to the present invention is shown. In this embodiment, a slit 6 is formed 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, contributes to the flexibility of the shell body, and makes it easier to attach the connecting band (not shown). Next, referring to Figure 6, the cranial shape correction helmet is viewed from below to explain how the liner of the present invention is attached. In the figure, the liner is depicted as a single continuous piece, but it is also within the scope of the present invention to use a liner divided at any suitable position, front, back, left, or right.

[0080] Figure 7 shows one embodiment of a cranial shape correction helmet according to the present invention. The cranial shape correction helmet 100 shown in Figure 1 has ventilation holes 3 on the surface of the outer shell 10. While diamond-shaped holes are arranged regularly in Figure 1, the shape of the ventilation holes in the present invention is not limited to this. The cranial shape correction helmet according to the present invention can also have a cushioning portion on the inside to provide cushioning for the head, and typically includes a liner approximately 2 to 20 mm thick made of foamed synthetic resin. This liner can be attached directly or indirectly to the cranial shape correction helmet 1, and the attachment means is not important to the present invention. Figure 7 shows an attachment portion 3 for attaching a hook-and-loop fastener to the inside of the cranial shape correction helmet 1 as one embodiment.

[0081] 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 to 3g are regularly arranged on the cranial shape correction helmet 1. In Figure 8, the area of ​​the ventilation through-holes is gradually reduced vertically from the center. This configuration makes it possible to efficiently ensure the ventilation area on the surface of the helmet, while also reinforcing the nape and top of the head by increasing the resin density.

[0082] In addition, in Figure 8, the ventilation holes 3a to 3g are arranged in the same horizontal row, and the ventilation holes 3a to 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 the case of typical plagiocephaly, the right and left occipital heights often differ, and by arranging the ventilation holes 3a to 3g as shown in Figure 8, such left-right differences can be easily checked.

[0083] Next, with reference to Figures 9 to 12, other configurations of the cranial shape correction helmet 100 of the present invention will be described. In addition to the configuration described in Figures 7 and 8, the cranial shape correction helmet 100 of the present invention has a generally spherical helmet shape, a top opening 8 and a bottom opening 9 through which the face and other parts of the head can be exposed, slits 6 are formed on the side of the head, and connecting members 5 are positioned horizontally in front and behind the slit 6. The slits on the side of the head may be on only one side, as shown in Figure 10, or on both sides. The slits 6 may simply be grooves, or may be configured so that the rear end fits into the front end (or vice versa). By appropriately opening the slits according to the wearer's head development, the slits can be adjusted without interfering with cranial growth, and the connecting members can be adjusted to adjust the speed and speed of the connecting members without placing strain on the wearer's skull.

[0084] 9, the connecting member 5 has an elliptical shape with protrusions on both ends of the long side diameter. 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 (FIG. 13).

[0085] A pair of reinforcing parts 7 are provided in the vertical direction on both front side surfaces of the cranial 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 cranial shape correction helmet 1 and the skull can be roughly fixed.

[0086] Next, referring to Figure 13, a further embodiment of the use of the cranial shape correction helmet 100 of the present invention will be described. In Figure 7, the cranial shape correction helmet 100 is provided with an inner liner 20 inside. Inner liner adhesive parts 4 for fastening the inner liner 20 are shown in Figure 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 head protection. The inner liner adhesive parts 4 can be attached in multiple locations on the inside of the cranial shape correction helmet 1. In the present invention, it is not intended that the means for attaching the inner liner be limited to those described above.

[0087] The material of the inner liner is not particularly limited, but examples thereof include foamed synthetic resin, preferably foamed polyurethane or foamed nylon, and more preferably open-cell foamed polyurethane (for example, product name "Memory Foam CF-45").

[0088] 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 be configured to have a ball resilience of about 15% or less.

[0089] In addition to the inner liner, by providing a thickening member (not shown) at the desired position on the forehead and / or back of the neck and / or left and right temporal regions, it is possible to further reduce the deviation between the shape of the cranial shape correction helmet and the shape of the child's skull, and to further reduce unnecessary vibrations of the cranial shape correction helmet.

[0090] The fixing band A used in the cranial shape corrective helmet 100 of the present invention may be made of any material and any fastening means as long as it can fasten the bands together while engaging with the fixing member 5. 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.

[0091] Next, the configuration of the connecting member 5 will be described with reference to FIG. 14 . In this embodiment, the connecting member 5 is elliptical, with protrusions (4U and 4D) extending from opposing ends of the long side in the diametric direction toward the center of the connecting member 5. In FIG. 14 , the protrusion at the top in the vertical direction is designated 4U, and the protrusion at the bottom is designated 4D. In the present invention, the cylindrical portion of the fixing band A, which has a cylindrical end engaging portion e, is engaged with the protrusions 4U and 4D, thereby attaching the fixing band to the rigid outer shell 10. The width of the engaging portion e is preferably approximately 0.5 to 1 mm shorter than the height direction H of the connecting member hole 55 shown in FIG. 14 , and the cylindrical diameter of the engaging portion e is preferably approximately 0.5 to 1 mm shorter than the width W of the connecting member hole 55. However, since the operability of attaching and detaching the fixing band varies depending on the material of the fixing band, the size of the engaging portion e can be appropriately adjusted to suit these conditions. Furthermore, in order to ensure proper engagement of the engaging portions e, the surfaces of the protruding portions 4U and 4D may be formed with a material or unevenness that easily generates frictional force.

[0092] Next, one embodiment of the fixing band of the present invention will be described with reference to Figures 15, 16, and 17. Figure 15 illustrates the configuration of the fixing band. In the present invention, the end f of the fixing band is folded to a suitable length based on the sizes of the connecting member 5, connecting member hole 55, and protrusions 4U and 4D, as described above, to align with dotted line a, and then secured by sewing or the like. When configured in this manner, the engaging portion e is formed into a cylindrical shape as shown in Figure 17. By appropriately folding this and engaging it with the protrusions 4U and 4D, the fixing band A can be attached to the hard shell. At this time, the width h of the fixing band is adjusted to the height H of the connecting member hole 55, as described above, before manufacturing. Figure 17 is a view of the fixing band A viewed from the thickness direction. As shown in Figure 15, by folding f to align with a and sewing it, a loop is formed, and the engaging portion e becomes cylindrical.

[0093] 15, 16, and 17 show examples of fixing bands with a locking portion e on one side. In FIG. 3A, by attaching a hook-and-loop fastener to area c and the locking portion e, the fixing band can be threaded through the connecting member and then fastened with the hook-and-loop fastener. Specifically, one of the opposing surfaces of the fixing band has a fine loop structure, and the other has a fine hook structure. Therefore, by simply passing the locking portion e of the individual band over the protruding portion of the connecting member and moving it back and forth once, the loop structure and the hook structure can be engaged and fixed. With this configuration, the fixing band A can secure the cranial shape correction helmet by simply moving it back and forth between the three connecting members once.

[0094] 18 shows the fixing band A 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 band 40 is engaged with the connecting hole by being caught on the protrusions 4U and 4D.

[0095] 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 a male loop on one side and a female loop on the other, with a tube threaded through it. As shown in Figure 20, the band is threaded through a connecting member, folded back, threaded through the tube, and then threaded through the connecting member on the other side. Finally, the band is passed back and forth between the connecting members, and the band is secured in a triple layer. By incorporating a conventional fixing band of this configuration into the present invention, not only is it possible to easily remove the fixing band 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 cranial shape correction helmet that is convenient not only for wearing but also for maintenance.

[0096] 1, 100: Cranial shape correcting helmet 10: Outer shell 20: Inner liner 21: Second polyurethane layer 22: First polyurethane layer 23: Adhesive layer 40, 40a, 40b, 40c, 40d: Hook-and-loop fastener member 41, 42: Hook-and-loop fastener member surface 400: Mesh structure 30: Reinforcement portion 3: Ventilation through-hole 4: Inner liner adhesive portion (inner liner attachment portion) 5: Connecting member 55: Connecting member hole 6: Slit 7: Reinforcement portion 8: Top opening 9: Lower opening A: Fixing band 11: Peripheral reinforcement portion 4U, 4D: Protrusion e: Locking portion

Claims

1. A skull correction helmet having a hard outer shell configured to cover the skull and having a plurality of ventilation holes formed therein.

2. A cranial shape correcting helmet as described in claim 1, characterized in that when the hard outer shell is attached, the opening area of ​​at least some of the multiple ventilation through holes varies upward and downward from the vertical center of the hard outer shell.

3. A helmet for correcting cranial shape as described in claim 2, wherein the opening area of ​​at least some of the plurality of ventilation through holes is largest at the vertical center and gradually becomes smaller as it moves away from the center.

4. A helmet for correcting cranial shape as described in claim 2 or 3, wherein the opening areas of at least a portion of the plurality of ventilation through holes are arranged symmetrically in the up-down direction from the vertical center.

5. A helmet for correcting cranial shape as described in claim 2 or 3, wherein the spacing between at least some of the multiple ventilation through holes is arranged symmetrically in the up and down directions from the vertical center.

6. A helmet for correcting cranial shape as described in claim 2 or 3, wherein the spacing between the ends of at least some of the multiple ventilation through holes is configured so as to gradually increase in the upward and downward directions from the vertical center, and the holes are arranged symmetrically.

7. A skull shape correction helmet as described in claim 2 or 3, wherein at least some of the plurality of ventilation through holes are equally spaced in an area corresponding to either the frontal bone, the parietal bone, or the occipital bone, or a combination thereof.

8. A helmet for correcting a cranial shape according to claim 2 or 3, wherein at least a portion of the plurality of ventilation through holes has a hole area sufficient for inserting a diagnostic tool.

9. A helmet for correcting a cranial shape as described in claim 2 or 3, comprising an inner liner removably disposed on at least a portion of the inner surface of the outer shell.

10. A helmet for correcting cranial shape as described in claim 2 or 3, wherein a slit is provided on at least one of the left and right sides of the outer shell.

11. A liner for a cranial shape correction helmet as claimed in claim 1, said liner comprising at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.

12. A liner for a cranial shape correction helmet as described in claim 11, wherein the foamed resin constituting the foamed synthetic resin layer is any one selected from the group consisting of polyurethane, polystyrene, polyethylene, polypropylene, EVA cross-linked foam, PET resin foam, and phenol foam.

13. A liner for a skull shape correction helmet as described in claim 11, wherein the foamed synthetic resin layer constituting the liner is bonded by any one of an adhesive layer, heat fusion and sewing.

14. A liner for a skull shape correction helmet as described in claim 13, wherein 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.

15. A liner for a cranial shape correction helmet as described in claim 11, wherein the first foamed synthetic resin layer has a different resilience than the second foamed synthetic resin layer.

16. A liner for a skull shape correction helmet as described in claim 11, wherein the first foamed synthetic resin layer has a lower resilience compared to the second foamed synthetic resin layer.

17. A liner for a cranial shape correction helmet as described in claim 11, wherein the first foamed synthetic resin layer and the second foamed synthetic resin layer have different thicknesses.

18. A liner for a cranial shape correction helmet as described in claim 11, wherein the first foamed synthetic layer is thicker than the second foamed synthetic layer.

19. A skull correction helmet comprising: an outer shell configured to cover a skull portion; and a liner including at least a first foamed synthetic resin layer and a second foamed synthetic resin layer.

20. A cranial shape correction helmet as described in claim 1, in which a hard outer shell of the cranial shape correction helmet has a slit formed on at least one side of the left or right side of the head, and connecting members are provided on both sides of the slit, and at least one of the connecting members is provided with a protrusion.

21. A cranial shape correction helmet as described in claim 1, in which the hard outer shell of the cranial shape correction helmet has a slit formed on at least one side of the left or right side of the head, and connecting members are provided on both sides of the slit, and the at least one connecting member has a protrusion and includes a fixing band having an engaging portion for engaging with the protrusion.

22. A cranial shape correction helmet as claimed in claim 20 or 21, wherein the protrusion comprises at least two protrusions protruding from a target position of the at least one connecting member.

23. A helmet for correcting cranial shape as described in claim 20 or 21, wherein the protrusion is shaped to become thinner toward the tip.

24. The cranial shape correction helmet 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.

25. The cranial shape correction helmet according to claim 24, wherein the helmet is fixed by folding back the connecting member located on the opposite side to the connecting member that is engaged with the engaging portion of the fixing band.

26. A cranial shape correction helmet as described in claim 20 or 21, wherein the width of the fixing band is the same as or slightly shorter than the width of the connecting hole in a direction perpendicular to the longitudinal direction of the band.

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