Skull shape correction helmet and method for manufacturing skull shape correction helmet

Abstract

To provide a skull shape correction helmet which suppresses the deviation of both ends of a shell with a simple configuration and easily obtains a stable wearing state, and to provide a method for manufacturing the same.SOLUTION: A skull shape correction helmet 10 includes: a shell 11; a restriction mechanism 21 for restricting the movement of a first end piece 14 in an up-down direction with respect to a second end piece 15 in a state where the first end piece 14 and the second end piece 15 of the shell 11 overlap each other; and a fixing mechanism 22 configured to be capable of adjusting a position of the first end piece 14 with respect to the second end piece 15 in a circumferential direction of the shell 11, wherein the restriction mechanism 21 has: a slit portion 211 formed in the first end piece 14 and extending in the circumferential direction; and a protrusion portion 212 disposed in the second end piece 15 and inserted into the slit portion 211, the slit portion 211 is formed to penetrate in a thickness direction of the shell 11 and is longer in the circumferential direction than in the up-down direction of the shell 11, and the protrusion portion 212 protrudes in the thickness direction of the shell 11 and slides in the slit portion 211 in the circumferential direction.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a cranial shape correction helmet that is worn on the head to correct cranial deformation, and a manufacturing method for the same. [Background technology]

[0002] Infants and young children may develop cranial deformities that require treatment, such as plagiocephaly (a deformed skull in which the skull is not symmetrical but tilts significantly to one side), brachycephaly (a deformed skull in which the front-to-back dimension is significantly shorter), and dolichocephaly (a deformed skull in which the front-to-back dimension is significantly longer). One device to treat such cranial deformities is the cranial shape correction helmet, which is worn on the head to promote skull shape correction as the skull grows.

[0003] Patent Document 1 discloses a skull shape correction helmet in which a liner is provided inside the shell and a slit is formed in the shell that extends vertically in a straight line from the upper edge to the lower edge. By deforming the shell by adjusting the width of the slit, the size of the inner space of the shell changes, allowing the head to be gently tightened with the required pressure. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2014-169510 Summary of the Invention [Problem to be solved by the invention]

[0005] If a gap extending vertically is formed in the shell, the pair of opposing ends sandwiching the gap will be prone to shifting in the front-to-back or vertical directions, making it difficult to achieve a stable mounting state. The above-mentioned Patent Document 1 discloses that a connecting means is used to keep the pair of ends overlapping each other, but this complicates the configuration and increases the number of parts.

[0006] The present invention aims to provide a cranial shape correction helmet with a simple structure that prevents misalignment of the ends on both sides of the shell, making it easy to achieve a stable wearing state, and a method for manufacturing the same. [Means for solving the problem]

[0007] (1) The cranial shape correction helmet of the present invention is a cranial shape correction helmet that is worn on the head to correct cranial deformities, and comprises: a roughly C-shaped shell having an upper opening and a lower opening; a regulating mechanism that regulates the vertical movement of a first end piece located at one end of the C-shape of the shell and a second end piece located at the other end of the shell when the first end piece is overlapped with a second end piece; and a fixing mechanism configured to adjust the position of the first end piece relative to the second end piece in the circumferential direction of the shell, wherein the regulating mechanism has a circumferentially extending slit portion formed in the first end piece and a protrusion portion disposed on the second end piece and inserted into the slit portion, the slit portion being formed through the thickness direction of the shell and being longer in the circumferential direction than in the vertical direction of the shell, and the protrusion portion protruding in the thickness direction of the shell and sliding circumferentially within the slit portion.

[0008] (2) In (1), the shell may have a butt portion facing the tip end surface of the first end piece, and the second end piece may be configured to be located outside the butt portion.

[0009] (3) In (1) or (2), the fixing mechanism may have a first locking portion on the first end piece and a second locking portion on the second end piece, the first locking portion and the second locking portion being respectively arranged on one side and the other side of the circumference, and the first end piece and the second end piece being connected to each other via a connecting member that is detachably hooked to at least one of the first locking portion and the second locking portion.

[0010] (4) In any of (1) to (3), the shell may have a deformable portion facing the treatment area requiring bulging deformation of the skull, forming a space between the shell and the treatment area to allow the bulging deformation of the skull, and the deformable portion may have a palpation hole that allows the distance between the deformable portion and the treatment area to be measured by palpation.

[0011] (5) A method for manufacturing a cranial shape correction helmet may be a method for manufacturing a cranial shape correction helmet described in any one of (1) to (4), and may include a step of molding the shell using a 3D printer based on the outer shape of the skull to be corrected. [Effects of the Invention]

[0012] According to the present invention, it is possible to provide a cranial shape correction helmet and a manufacturing method thereof that has a simple configuration and suppresses misalignment of the ends on both sides of the shell, making it easy to achieve a stable wearing state. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a diagram showing a state in which a person to be treated for cranial deformity is wearing the cranial shape correcting helmet according to embodiment 1. FIG. [Figure 2] 1 is a view of the restriction mechanism of the cranial shape corrective helmet according to the first embodiment, seen from the head side (inside). FIG. [Figure 3] FIG. 1 is a view of the cranial shape corrective helmet according to embodiment 1, observed from the outside before being fixed. [Figure 4] FIG. 1 is a view of the cranial shape corrective helmet according to embodiment 1, observed from the inside before being fixed. [Figure 5] FIG. 2 is a view of the cranial shape corrective helmet according to embodiment 1, observed from the outside after being fixed. [Figure 6] FIG. 2 is a cross-sectional view corresponding to line II-II in FIG. [Figure 7] FIG. 7 is an enlarged view of a main part of FIG. 6. [Figure 8]This is a cross-sectional view of the head and cranial shape correction helmet when the subject is lying on their back. [Figure 9] 1 is a cross-sectional view of a head and a cranial shape correcting helmet showing a cushion of the cranial shape correcting helmet according to a first modified example. FIG. [Figure 10] FIG. 10 is a cross-sectional view of a head and a cranial shape correcting helmet showing a cushion of the cranial shape correcting helmet according to a second modified example. [Figure 11] FIG. 10 is a perspective view of a cranial shape corrective helmet according to a second embodiment in a fixed state. [Figure 12] 10 is a view of the restricting mechanism and fixing mechanism of the cranial shape corrective helmet according to embodiment 2, observed from the back of the head. FIG. [Figure 13] 10 is a view of the restricting mechanism and fixing mechanism of the cranial shape corrective helmet according to embodiment 2, observed from the neck direction. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0014] A cranial shape correcting helmet 10 according to a first embodiment of the present invention will be described below with reference to the drawings. (Embodiment 1) <Basic structure of the skull correction helmet> 1 shows a state in which a treatment subject 1, such as an infant with a cranial deformation symptom, wears a cranial shape correcting helmet 10 according to embodiment 1 on the head 2 of the treatment subject 1. The cranial shape correcting helmet 10 is worn on the head 2 of the treatment subject 1 to correct the cranial deformation of the head 2 of the treatment subject 1.

[0015] In Figure 1, arrow X indicates the front-to-back direction of the cranial shape corrective helmet 10 when worn by the treatment recipient 1, with X1 indicating the front side and X2 indicating the back side. Arrow Y indicates the left-to-right direction of the cranial shape corrective helmet 10 when worn by the treatment recipient 1, with Y1 indicating the left side and Y2 indicating the right side. Arrow Z indicates the up-down direction of the cranial shape corrective helmet 10 when worn by the treatment recipient 1, with Z1 indicating the top side and Z2 indicating the bottom side. This also applies to Figure 2 and subsequent figures.

[0016] As shown in FIG. 1 , the shell 11 is C-shaped and has an upper opening 12 and a lower opening 13. The abutment portion 16 and the end of the shell 11 face each other, with a gap between them. The top of the head 2 is exposed above the upper opening 12, and the face, ears, neck, etc. are exposed below the lower opening 13. The shell 11 has a first end piece 14 located at one end and extending in the front-to-rear direction, and a second end piece 15 located at the other end and overlapping with the first end piece 14.

[0017] The shell 11 is equipped with a regulating mechanism 21 that fixes the vertical position of the first end piece 14 relative to the second end piece 15, and a fixing mechanism 22 that fixes the front-to-back position between the first end piece 14 and the second end piece 15.

[0018] In the C-shaped shell 11 of the cranial shape correction helmet 10, the direction of rotation around the line connecting the head and neck as an axis is called the circumferential direction. The front-to-back position between the first end piece 14 and the second end piece 15 is part of the circumferential direction. When the front-to-back position between the first end piece 14 and the second end piece 15 is changed, the circumferential size of the cranial shape correction helmet 10, i.e., the diameter of the cranial shape correction helmet 10, is changed.

[0019] The regulating mechanism 21 provided in the cranial shape correcting helmet 10 has a slit portion 211 which is a long, narrow hole that is formed through the first end piece 14 in a direction intersecting the thickness direction T of the shell 11 and extends in the front-to-back direction, and a protrusion portion 212 that protrudes in the thickness direction T of the shell 11 in the second end piece 15 and is inserted into the slit portion 211.

[0020] The slit portion 211 extends in the front-to-rear direction, and the protrusion portion 212 slides within the slit portion 211. When an external force is applied to the cranial shape corrective helmet 10 such that the first end piece 14 moves in the vertical direction relative to the second end piece 15, the protrusion portion 212 hits the wall of the slit portion 211. This restricts the protrusion portion 212 from moving in the vertical direction Z relative to the first end piece 14.

[0021] The shape of the slit portion 211 constituting the restriction mechanism 21 when viewed in the thickness direction T of the shell 11 may be rectangular, and the protrusion portion 212 may be a rectangular parallelepiped. This provides a restriction mechanism 21 with excellent fit, and particularly suppresses displacement of the shell 11 in the vertical direction.

[0022] Furthermore, the cranial shape corrective helmet 10 is equipped with a fixing mechanism 22 that fixes the position of the first end piece 14 in the front-to-rear direction X. The fixing mechanism 22 has a first locking portion 221 on the first end piece 14 and a second locking portion 225 on the second end piece 15. The first locking portion 221 and the second locking portion 225 are arranged relative to each other in the front-to-rear direction. The first end piece 14 and the second end piece 15 are connected to each other via a connecting member 220 that is detachably hooked onto the first locking portion 221 and the second locking portion 225, respectively.

[0023] A more detailed explanation will be given. The first locking portion 221 has an annular fitting 222, a first band-shaped body 223, and a first fixing pin 224 that is fixed to a hole formed in the first end piece 14. The first band-shaped body 223 passes through the ring of the annular fitting 222, and both ends of the first band-shaped body 223 are fixed by the first fixing pin 224. One end of the annular fitting 222 is fixed by the first band-shaped body 223.

[0024] The second locking portion 225 has a second fixing pin 227. The second fixing pin 227 is fixed to the shell 11 based on a hole provided in the shell 11.

[0025] One end of the second band 226 constituting the connecting member 220 is fixed to the shell 11 via a second fixing pin 227. The other end of the second band 226 passes through the annular metal fitting 222, is bent, and overlapped with the second band 226 (itself). The second band 226 is a well-known hook-and-loop fastener whose adhesive surfaces are bondable and releasable. The adhesive surfaces of the second bands 226 are joined together with an appropriate amount of tension. The second bands 226 are joined and fixed in the front-to-rear direction at any overlapping position. As a result, the distance between the first fixing pin 224 and the second fixing pin 227 is fixed, and the distance in the front-to-rear direction X between the first end piece 14 and the second end piece 15 is also fixed.

[0026] As described above, the first end piece 14 and the second end piece 15 are fixed in the up-down direction Z and the front-to-back direction (circumferential direction) by the restriction mechanism 21 and the fixing mechanism 22. By adjusting the overlapping position of the second band-shaped body 226, the front-to-back position of the first end piece 14, i.e., the diameter of the cranial shape corrective helmet 10, can be adjusted. In other words, the fixing mechanism 22 is configured to allow the front-to-back position of the first end piece 14 relative to the second end piece 15 to be adjusted.

[0027] The first end piece 14 has a gauge portion 213 near the slit portion 211 and along the longitudinal direction of the slit portion 211. The gauge portion 213 is, for example, a scale consisting of straight lines drawn at equal intervals perpendicular to the longitudinal direction of the slit portion 211. By observing the relationship between the gauge portion 213 and the protrusion portion 212, the relative positions of the first end piece 14 and the second end piece 15 can be estimated.

[0028] In FIG. 1, the protrusion 212, slit 211, and gauge 213 are hidden by the second end piece 15 and are indicated by dotted lines. FIG. 2 is a perspective view of the shell 11 as viewed from the head side or rear side. The protrusion 212 of the second end piece 15 is fitted into the slit 211 of the first end piece 14. The gauge 213 is provided near the slit 211 and along the longitudinal direction of the slit 211. The shell 11 has an abutment 16 facing the tip surface of the first end piece 14. When the distance between the first fixing pin 224 and the second fixing pin 227 is narrowed and the outer shape of the cranial shape corrective helmet 10 becomes smaller, the abutment 16 abuts against the tip surface of the first end piece 14. In FIG. 2, the protrusion 212 is located at the end of the slit 211, and the shell 11 and the first end piece 14 abut against each other at the abutment 16.

[0029] 3 to 5, a state in which the protrusion 212 and the slit portion 211 are neither engaged nor fixed to each other (see FIGS. 3 and 4) and a state in which the protrusion 212 and the slit portion 211 are engaged and fixed to each other (see FIG. 5) will be described. In the state in which the protrusion 212 and the slit portion 211 are neither engaged nor fixed to each other (FIG. 3), the first band-shaped body 223 is passed through the ring of the annular metal fitting 222 and is pinned by a first fixing pin 224. One end of the second band-shaped body 226 is pinned to a second fixing pin 227, which is hidden behind the second band-shaped body 226 and not shown in FIG. 3, but the other end is not fixed.

[0030] 4 is a view of the first end piece 14 and the second end piece 15 in this state, viewed from the head side, in other words, from the back side. The first end piece 14 and the second end piece 15 are separated and do not overlap, and the protrusion 212 is not fitted into the slit portion 211.

[0031] Figure 5 shows the state in which the first end piece 14 and the second end piece 15 are overlapped. Figure 5 is a view of the skull shape corrective helmet 10 as seen from the front side. Unlike Figure 1, parts that are hidden and cannot be seen are not shown. Because the overlap between the first end piece 14 and the second end piece 15 is small, the slit portion 211 provided in the first end piece 14 can be seen from the outside.

[0032] <Relationship with the head shape of the patient (details of correction)> 6 to 10, how to deal with the deformed shape of the skull of the treatment subject 1 in the first embodiment will be described.

[0033] The skull of the example of the treatment subject 1 has an asymmetrical plagiocephaly that tilts to the right as it moves forward when viewed from above. In Figure 6, the treatment subject 1 is lying on his back, with the top of his head facing forward. The cross section of the head 2 of the treatment subject 1 has a shape that extends to the upper right and lower left. As the head 2 of the treatment subject 1 is not a component that constitutes the cranial shape correction helmet 10, the diagonal lines indicating the cross section are omitted and only the outline of the cross section is shown. The same applies below.

[0034] An ideal three-dimensional model is created based on the external shape of the plagiocephaly skull, and the shape of the shell 11 is designed based on this three-dimensional model. For example, the head 2 of the treatment subject 1 is 3D scanned to obtain the three-dimensional shape of the head 2 of the treatment subject 1. Next, an ideal three-dimensional shape as a treatment target is created based on the three-dimensional shape of the head 2, and the shape of the shell 11 is determined based on this ideal three-dimensional shape.

[0035] The shell 11 of the first embodiment can be manufactured, for example, by a 3D printer as described below, but the manufacturing method is not limited to this. The shell 11 is a synthetic resin molded body and has the required surface hardness and rigidity. Therefore, in addition to using a 3D printer, it can also be molded by cutting a block of synthetic resin. Examples of synthetic resins include, but are not limited to, polyamide, polycarbonate, polyester, ABS resin, epoxy resin, and fluororesin.

[0036] The skull has multiple treatment areas 3 that create a space S between the shell 11 and the skull when the skull shape correction helmet 10 is worn. The skull also has multiple pressure receiving portions 4 that come into contact with the skull shape correction helmet 10 and are pressed by the skull shape correction helmet 10. The multiple treatment areas 3 are located on the left front side and the right rear side. The multiple pressure receiving portions 4 are located on the right front side and the left rear side. The shell 11 has a deformable portion 317 in each portion facing the treatment areas 3. Each deformable portion 317 is formed to create a required space S between the shell 11 and the treatment area 3. Each deformable portion 317 allows the skull to bulge and deform into the space S. The shell 11 also has a pressing portion 318 in each portion facing the pressure receiving portion 4. Each pressing portion 318 presses the pressure receiving portion 4 inward.

[0037] When the cranial shape correcting helmet 10 is worn, each pressure receiving portion 4 is pressed inward by the pressing portion 318 with appropriate pressure. This causes the treatment area 3 to grow preferentially and bulge outward, correcting the skull so that it is bilaterally symmetrical. A cushion 330 that comes into contact with the pressure receiving portion 4 is arranged on the inner surface of the pressing portion 318. The cushion 330 prevents the hard shell 11 from directly hitting the head 2 and causing damage to the head 2. Although a cushion 330 is not arranged inside the deformable portion 317, it may be arranged there. If arranged, it is preferable that a space S be left between the cushion 330 and the head 2.

[0038] Shell 11 has a plurality of holes 19 at least in deformable portion 317. Holes 19 communicate with the inside and outside of shell 11. Holes 19 may have any shape, such as a circle, a trapezoid, or a triangle. Holes 19 may have irregular sizes and may be of various sizes. Holes 19 ensure breathability and contribute to weight reduction.

[0039] Among the multiple holes 19, particularly in the case of a circular shape, there is a hole 19 with a diameter of 10 mm to 25 mm so that a finger can be inserted, and this hole 19 is designated as a palpation hole 19a. Palpation hole 19a is a hole 19 that allows a treating physician or the like to insert a finger from the outside of shell 11 to measure by palpation the distance between the inner surface of deformable portion 317 and treatment site 3. There may be multiple palpation holes 19a in deformable portion 317. Furthermore, palpation hole 19a is not limited to being circular, but its size is set to a size equivalent to a diameter of 10 mm to 25 mm.

[0040] When a treatment subject 1 with plagiocephaly lies on their back, for example, while sleeping, they often have a habit of having the treatment area 3 in the Y2 direction of the back of the head 2 point downward, as shown in Fig. 8. In this state, the shell 11 is subjected to a downward load at a position P corresponding to a slightly upper right portion of the head 2. In the first embodiment, the first end piece 14 and the second end piece 15 are formed at the position P where a downward load is applied from the first end piece 14 when the treatment subject 1 with plagiocephaly lies on their back, which is a characteristic position of the treatment subject 1 with plagiocephaly.

[0041] At position P, the second end piece 15 overlaps the first end piece 14 by a wide margin, and the second band 226 prevents them from expanding in the X direction. This makes it difficult for the first end piece 14 and the second end piece 15 to come loose from their fitted state. This makes it easier for the shape of the shell 11 to be maintained, and treatment progresses normally.

[0042] As shown in Figure 8, the first end piece 14 and the second end piece 15 are drawn together via the first band 223, the annular fitting 222, and the second band 226, causing the shell 11 to contract slightly in diameter and applying the required pressure to the head 2. Treatment then proceeds normally.

[0043] As shown in Fig. 8, abutment portion 16 faces the end of shell 11. When the diameter of shell 11 tries to shrink, the end of shell 11 comes into contact with abutment portion 16, preventing further shrinkage of the diameter of shell 11. This can prevent problems such as the diameter of shell 11 shrinking too much and causing pain to treatment subject 1.

[0044] Cushion 330 is disposed on the inner surface of each pressing portion 318 of shell 11. Cushion 330 is a molded body made of foamed synthetic resin with resilience. Cushion 330 is detachably attached to the inner surface of shell 11 using, for example, double-sided adhesive tape.

[0045] Each cushion 330 is provided with a pressure sensor 350 that detects pressure corresponding to the reaction force received from the pressure receiving portion 4 pressed by the pressing portion 318. The pressure sensor 350 is preferably provided at a position that is expected to receive the greatest pressure from the skull. A suitable pressure sensor 350 is a sheet-type pressure sensor that uses a rectangular film substrate that is less than 1 mm thick and approximately 1 mm square. Such a pressure sensor 350 is used by being placed, for example, in a recess provided on the inner surface of the cushion 330. For example, a cable for capturing measurement data is connected to the pressure sensor 350, and the measured value of the pressure applied from the pressure receiving portion 4 to the cushion 330 is displayed on a display device such as a personal computer.

[0046] As described above, the cranial shape correcting helmet 10 is a cranial shape correcting helmet 10 that is worn on the head 2 to correct cranial deformities, and comprises: a roughly C-shaped shell 11 having an upper opening 12 and a lower opening 13; a regulating mechanism 21 that regulates the vertical movement of the first end piece 14 relative to the second end piece 15 when the first end piece 14 located at one end of the C of the shell 11 and the second end piece 15 located at the other end of the shell 11 are overlapping; and a fixing mechanism 22 that is configured to adjust the position of the first end piece 14 relative to the second end piece 15 in the circumferential direction of the shell 11.

[0047] This makes it possible to provide a cranial shape correction helmet 10 and a manufacturing method thereof that has a simple configuration and prevents the ends of the shell 11 from shifting, making it easier to achieve a stable wearing state.

[0048] In the cranial shape correcting helmet 10, the regulating mechanism 21 has a circumferentially extending slit portion 211 formed in the first end piece 14, and a protrusion portion 212 arranged on the second end piece 15 and inserted into the slit portion 211.

[0049] This results in a skull shape correction helmet 10 that prevents vertical displacement of the shell 11. The first end piece 14 and the second end piece 15 are overlapped and fixed in the thickness direction of the shell 11, making it easier to achieve a stable wearing state of the skull shape correction helmet 10.

[0050] In the cranial shape correcting helmet 10, the first end piece 14 is located on the head side, the second end piece 15 is located on the opposite side of the head 2 from the first end piece 14, and the protrusion 212 protrudes towards the head side.

[0051] This makes it possible to make the slit portion 211 invisible from the outside, resulting in a skull shape correcting helmet 10 with excellent design.

[0052] In the skull shape correcting helmet 10, the shell 11 has an abutment portion 16 that faces the tip surface of the first end piece 14, and the second end piece 15 is located outside the abutment portion 16.

[0053] It is conceivable that the diameter of shell 11 may shrink due to the application of an unexpected external force or the unexpected contraction of second band-shaped body 226. Even in this case, the contraction of the diameter of shell 11 is prevented by the contact between the tip surface of shell 11 and abutment portion 16. This prevents damage to head 2 of the treatment subject 1.

[0054] In the cranial shape correcting helmet 10, the fixing mechanism 22 has a first locking portion 221 on the first end piece 14 and a second locking portion 225 on the second end piece 15, with the first locking portion 221 and the second locking portion 225 respectively arranged on one and the other circumferential sides of each other, and the first end piece 14 and the second end piece 15 being connected to each other via a connecting member 220 that is detachably hooked onto at least one of the first locking portion 221 and the second locking portion 225.

[0055] This particularly prevents displacement of the shell 11 in the front-to-rear direction. The tightening strength of the shell 11 can be adjusted by adjusting the tension of the second band-shaped body 226, and the second band-shaped body 226 can be easily replaced.

[0056] In the skull shape correction helmet 10, the shell 11 faces the treatment area 3 that requires bulging deformation of the skull, and has a deformation-permitting portion 317 that forms a space S between the treatment area 3 and allows the skull to bulge and deform, and the deformation-permitting portion 317 is provided with a palpation hole 19a that allows the distance between the deformation-permitting portion 317 and the treatment area 3 to be measured by palpation.

[0057] This allows the progress of treatment to be easily confirmed by palpation using the palpation hole 19a without removing the cranial shape correcting helmet 10 from the head 2.

[0058] The cranial shape correcting helmet 10 has a gauge portion 213 that indicates the relative positions of the first end piece 14 and the second end piece 15.

[0059] This allows the size of the skull shape correcting helmet 10 to be adjusted while being grasped, and skull adjustment can be performed with a rough guide.

[0060] The cranial shape corrective helmet 10 can be manufactured by the following method: a step of molding the shell 11 using a 3D printer based on the outer shape of the skull of the head 2 to be corrected is performed, and then a step of placing the cushion 330 inside the shell 11 is performed. As described above, the shape of the shell 11 is determined based on the ideal three-dimensional shape that is the treatment target, which is created based on the three-dimensional shape of the head 2 of the treatment recipient 1.

[0061] As described above, the method for manufacturing the cranial shape correcting helmet 10 is a method for manufacturing the cranial shape correcting helmet 10, and includes a step of molding the shell 11 using a 3D printer based on the external shape of the skull to be corrected.

[0062] This allows the cranial shape corrective helmet 10 to be suitably manufactured as a custom-made corrective device tailored to each individual patient.

[0063] There are various specific methods for forming the shell 11 using a 3D printer, including well-known methods such as liquid vat photopolymerization, material jetting, binder jetting, powder bed fusion, material extrusion, directed energy deposition, and sheet lamination.

[0064] Next, a modified example of the cushion 330 of the first embodiment will be described with reference to Figures 9 and 10. In the description of the modified example, the configuration other than the cushion 330 is the same as that of the first embodiment, so the same components are given the same reference numerals and the description of those configurations will be omitted.

[0065] 9 shows a first modified example of cushion 330. This cushion 330 includes a first cushion portion 331 disposed substantially in the center of pressure receiving portion 4, and a second cushion portion 332 disposed around first cushion portion 331. These cushion portions 331, 332 are both molded bodies made of foamed synthetic resin with resilience, and are detachably attached to the inner surface of shell 11 via, for example, double-sided adhesive tape. First cushion portion 331 and second cushion portion 332 have different resilience, with first cushion portion 331 being softer and having lower resilience than second cushion portion 332.

[0066] Both the first cushion portion 331 and the second cushion portion 332 come into contact with the head 2 under pressure, but because the first cushion portion 331 is disposed in the center, the first cushion portion 331 comes into contact with the head 2 with a higher pressure than the second cushion portion 332. In this way, in accordance with the level of pressure, the first cushion portion 331, which comes into contact with the head 2 with a relatively high pressure, has lower resilience than the second cushion portion 332.

[0067] According to the cushion 330 of the first modified example, the first cushion part 331, which comes into contact with the head 2 with a relatively high pressure, is made to have lower resilience than the second cushion part 332, thereby minimizing damage to the head 2 and making it easier to obtain a comfortable fit.

[0068] 10 shows a second modified example of the cushion 330. This cushion 330 has a two-layer structure including a third cushion portion 333 that directly contacts the pressure receiving portion 4 and a fourth cushion portion 334 that is arranged on the outside of the third cushion portion 333 in the thickness direction T. The fourth cushion portion 334 is detachably attached to the third cushion portion 333, for example, via double-sided adhesive tape. The third cushion portion 333 and the fourth cushion portion 334 have different resilience, with the third cushion portion 333 being softer and having lower resilience than the fourth cushion portion 334.

[0069] According to the cushion 330 of the second modification, the third cushion part 333, which is in direct contact with the pressure receiving part 4, has lower resilience than the fourth cushion part 334, so that damage to the head 2 can be kept as low as possible and a comfortable fit can be easily obtained.

[0070] Furthermore, as a modified example of the pressure sensor 350, the pressure sensor 350 may not always be set in the cushion 330, and the cushion 330 may only have a recess formed therein for removably storing the pressure sensor 350. The recess preferably has a shape that corresponds to the shape of the pressure sensor 350 and allows the pressure sensor 350 to fit into it. In this case, when inspecting the pressure applied to the pressure receiving portion 4 of the head 2, the pressure sensor 350 is stored and set in the recess of the cushion 330.

[0071] As described above, in the cranial shape correcting helmet 10, the cushion 330 is arranged so as to contact the pressure receiving portion 4 of the head 2 to which pressure is applied from the shell 11, and the cushion 330 includes a first cushion portion 331 arranged approximately in the center of the pressure receiving portion 4 and a second cushion portion 332 arranged around the first cushion portion 331, and the first cushion portion 331 has lower resilience than the second cushion portion 332.

[0072] This makes it possible to minimize damage to the head 2 and also to make it easier to obtain a comfortable fit.

[0073] In the cranial shape correcting helmet 10, the cushion 330 is arranged so as to contact the pressure receiving portion 4 of the head 2 to which pressure is applied from the shell 11, and the cushion 330 includes a third cushion portion 333 that directly contacts the pressure receiving portion 4 and a fourth cushion portion 334 that is arranged outside the third cushion portion 333 in the thickness direction, and the third cushion portion 333 has lower resilience than the fourth cushion portion 334.

[0074] This makes it possible to minimize damage to the head 2 and also to make it easier to obtain a comfortable fit. When the amount of deformation of the head 2 is large, the deformation is more strongly corrected by the high resilience of the fourth cushion part 334. When the amount of deformation of the head 2 is small, strong correction is not necessary, and correction by the low resilience of the third cushion part 333 alone is sufficient. As a result, a comfortable fit and appropriate correction are achieved.

[0075] In the cranial shape correcting helmet 10, the cushion 330 is positioned so as to contact the pressure receiving portion 4 of the head 2 to which pressure is applied from the shell 11, and a pressure sensor 350 that detects pressure corresponding to the reaction force received from the pressure receiving portion 4 is positioned on the cushion 330.

[0076] This allows the pressure sensor 350 to detect the tightness of the cranial shape corrective helmet 10, making it possible to quantitatively evaluate the tightness.

[0077] (Embodiment 2) In the above-described first embodiment, the regulating mechanism 21 that fixes the position in the up-down direction and the fixing mechanism 22 that adjusts and fixes the position in the front-to-rear direction are provided separately. In the second embodiment, as shown in FIG. 11 , in the cranial shape corrective helmet 10, the first end piece 14 has an insertion portion 231 that extends in the front-to-rear direction, and the second end piece 15 has an insertion portion 232 into which the insertion portion 231 can be inserted. The insertion portion 231 has a plurality of fixing grooves 233 in the extension direction. The fixing piece 234 is rotatably engaged with the insertion portion 232. The fixing piece 234 fits into the fixing groove 233 of the insertion portion 231, and the insertion portion 231 is fixed to the insertion portion 232.

[0078] 12 and 13 are enlarged perspective views of the insertion portion 231 and the insertion portion 232. As shown in Fig. 12 and 13, the fixing piece 234 is supported by a hinge portion 238 provided in the insertion portion 232. The fixing piece 234 is provided so as to be movable between a fixed position where it is inserted into the fixing groove 233 and a spaced position where it is spaced from the fixing groove 233.

[0079] A more detailed explanation will be given below. Insertion portion 232 has an upper restriction portion 236 that protrudes from the outer surface of shell 11. Furthermore, insertion portion 232 has a lower restriction portion 237 that protrudes from the outer surface of shell 11 and is positioned to sandwich insertion portion 231 in the inserted state together with upper restriction portion 236.

[0080] The fixed piece 234 is rotatably supported by the tip of the upper restricting portion 236 and the tip of the lower restricting portion 237 via a hinge portion 238. The fixed piece 234 has a fixed protrusion 235 near the tip of the upper restricting portion 236 and the tip of the lower restricting portion 237.

[0081] The insertion portion 231 is inserted into the insertion portion 232 in a state where the second end piece 15 of the shell 11 is positioned outward of the first end piece 14 of the shell 11 and the fixing piece 234 is positioned so that the fixing protrusion 235 faces away from the shell 11. Then, the fixing piece 234 is rotated so that the fixing protrusion 235 fits into the fixing groove 233 of the insertion portion 231. This fixes the position of the insertion portion 231.

[0082] In embodiment 2, the regulating mechanism 21 that fixes the vertical positions of the first end piece 14 and the second end piece 15 of the shell 11 includes upper and lower side surfaces of the insertion portion 231, an upper regulating portion 236 of the insertion portion 232, and a lower regulating portion 237 of the insertion portion 232.

[0083] In the second embodiment, fixing mechanism 22, which fixes the left-right positions of first end piece 14 and second end piece 15 of shell 11, includes an inserting portion 231 and an inserting portion 232. In particular, fixing mechanism 22 includes a fixing groove 233 of inserting portion 231 and a fixing protrusion 235 of fixing piece 234.

[0084] As described above, in the cranial shape correcting helmet 10, the first end piece 14 has an insertion portion 231 extending in the circumferential direction, the second end piece 15 has an insertion portion 232 into which the insertion portion 231 can be inserted, the regulating mechanism 21 has the insertion portion 232 that regulates the vertical position of the insertion portion 231, and the fixing mechanism 22 fixes the circumferential position of the insertion portion 231 inserted into the insertion portion 232.

[0085] As a result, the main part having the insertion part 231 and the insertion part 232 is responsible for both the vertical regulation and the front-rear fixing, and an easy-to-use regulation mechanism 21 and fixing mechanism 22 are realized.

[0086] As described above, in the cranial shape correcting helmet 10, the regulating mechanism 21 has, in the insertion portion 232, an upper regulating portion 236 that protrudes from the outer surface of the shell 11, and a lower regulating portion 237 that protrudes from the outer surface of the shell 11 and is positioned to sandwich the insertion portion 231 in the inserted state together with the upper regulating portion 236, and the fixing piece 234 is rotatably supported on the tip of the upper regulating portion 236 and the tip of the lower regulating portion 237.

[0087] This restricts the vertical movement of the fixing piece 234, and as a result, restricts the vertical position of the shell 11. The upper restricting portion 236 and the lower restricting portion 237 are immovable portions that form part of the insertion portion 232, and the insertion portion 231, which comes into contact with these and is restricted in its movement, can hardly move up or down. As a result, strong fixation is achieved.

[0088] In the cranial shape correcting helmet 10, the plug portion 231 is inserted into the insertion portion 232 with the second end piece 15 of the shell 11 positioned outside the first end piece 14 of the shell 11, and the position of the plug portion 231 is fixed by the fixing mechanism 22.

[0089] As a result, the insertion portion 231 is inserted into the insertion portion 232 in a state where it is visible from the outside, making the insertion easy and the insertion position easy to adjust.

[0090] In the cranial shape correcting helmet 10, the shell 11, the first end piece 14 and the second end piece 15 may be formed as an integral member.

[0091] Because the components are integrated, stress concentration at the joints between different components is prevented, resulting in high durability and preventing problems such as the shape of the skull being distorted.

[0092] In the cranial shape correcting helmet 10, when the head 2 is in a substantially supine position, the first end piece 14 extends downward, and the second end piece 15 is disposed outside the first end piece 14. In the cranial shape correcting helmet 10, when the head 2 is in a substantially supine position, it is preferable that the overlapping portion of the first end piece 14 and the second end piece 15 is formed at a position P corresponding to the portion of the side of the head 2 where a downward load is applied.

[0093] As a result, when the patient is lying on his back, which is a characteristic of plagiocephaly, as shown in Figure 8, excessive weight is placed on the tough part that is twice as thick due to the overlap. This allows the shape of the shell 11 to be maintained, and treatment to proceed normally.

[0094] The present invention is not limited to the above-described embodiments, and can be modified as appropriate.

[0095] The shapes of the first locking portion 221 and the second locking portion 225, and the first band-shaped body 223, the annular metal fitting 222, and the second band-shaped body 226 as the connecting member 220 are not limited to the embodiment, and can be changed as appropriate.

[0096] The palpation hole 19a of the shell 11 may be provided as needed, or may not be provided at all. The pressure sensor 350 may be omitted.

[0097] (1) The cranial shape correction helmet of the present invention is a cranial shape correction helmet that is worn on the head to correct cranial deformities, and comprises a roughly C-shaped shell having an upper opening and a lower opening, a regulating mechanism that regulates the vertical movement of a first end piece located at one end of the C-shape of the shell relative to a second end piece located at the other end of the shell when the first end piece is overlapped with a second end piece, and a fixing mechanism configured to adjust the position of the first end piece relative to the second end piece in the circumferential direction of the shell.

[0098] (2) In (1), the regulating mechanism may have a circumferentially extending slit portion formed in the first end piece, and a protrusion portion disposed on the second end piece and inserted into the slit portion.

[0099] (3) In (2), the first end piece may be located on the head side, the second end piece may be located on the opposite side of the head from the first end piece, and the protrusion may protrude toward the head side.

[0100] (4) In any of (1) to (3), the shell may have a butt portion facing the tip surface of the first end piece, and the second end piece may be configured to be located outside the butt portion.

[0101] (5) In any of (2) to (4), the fixing mechanism may have a first locking portion on the first end piece and a second locking portion on the second end piece, the first locking portion and the second locking portion being respectively arranged on one side and the other side of the circumferential direction, and the first end piece and the second end piece being connected to each other via a connecting member that is detachably hooked to at least one of the first locking portion and the second locking portion.

[0102] (6) In (1), the first end piece may have an insertion portion extending in the circumferential direction, the second end piece may have an insertion portion into which the insertion portion can be inserted, the regulating mechanism may have an insertion portion that regulates the vertical position of the insertion portion, and the fixing mechanism may be configured to fix the circumferential position of the insertion portion inserted into the insertion portion.

[0103] (7) In any one of (1) to (6), a gauge portion may be provided to indicate the relative position of the first end piece and the second end piece.

[0104] (8) In any of (1) to (7), the shell may have a deformable portion facing the treatment area requiring bulging deformation of the skull, forming a space between the shell and the treatment area to allow the bulging deformation of the skull, and the deformable portion may have a palpation hole that allows the distance between the deformable portion and the treatment area to be measured by palpation.

[0105] (9) In any of (1) to (8), the cushion may be arranged to contact a pressure receiving portion of the head to which a pressure is applied from the shell, and the cushion may include a first cushion portion arranged approximately in the center of the pressure receiving portion and a second cushion portion arranged around the first cushion portion, and the first cushion portion may have lower resilience than the second cushion portion.

[0106] (10) In (9), the cushion is arranged so as to contact the pressure receiving portion of the head to which pressure is applied from the shell, and the cushion may include a third cushion portion that directly contacts the pressure receiving portion and a fourth cushion portion that is arranged outside the third cushion portion in the thickness direction, and the third cushion portion may be configured to have lower resilience than the fourth cushion portion.

[0107] (11) In (9) or (10), the cushion may be arranged so as to contact the pressure receiving portion of the head to which the pressing force from the shell is applied, and a pressure sensor that detects pressure corresponding to the reaction force received from the pressure receiving portion may be arranged on the cushion.

[0108] (12) A method for manufacturing a cranial shape correction helmet may be a method for manufacturing a cranial shape correction helmet described in any one of (1) to (11), and may include a step of molding the shell using a 3D printer based on the outer shape of the skull to be corrected. [Explanation of symbols]

[0109] 1. Target patients for treatment 2 heads 3 Treatment area 4 Pressure receiving part 10. Cranial Shape Correction Helmets 11 Shell 12 Upper opening 13 Lower opening 14 First end piece 15 Second end piece 16 End 19 holes 19a Palpation hole 21 Regulatory Mechanisms 211 Slit section 212 Protrusion 213 Gauge section 22 Fixing mechanism 220 Connecting member 221 First locking part 222 Annular metal fittings 223 First Band 224 First fixing pin 225 Second locking part 226 Second fascicle 227 Second fixing pin 231 Insertion part 232 Insertion section 233 Fixed groove 234 Fixed piece 235 Fixed protrusion 236 Upper restriction part 237 Lower restriction part 238 Hinge part 317 Deformation tolerance section 318 Pressing section 330 Cushion 331 First cushion section 332 Second cushion section 333 Third cushion section 334 4th cushion section 350 Pressure Sensor S Space

Claims

1. A skull shape correction helmet that is worn on the head to correct skull deformation, a generally C-shaped shell having an upper opening and a lower opening; a restricting mechanism that restricts vertical movement of the first end piece relative to the second end piece when the first end piece is located at one end of the C-shape of the shell and the second end piece is located at the other end of the shell, in a state where the first end piece overlaps the second end piece; a fixing mechanism configured to adjust the position of the first end piece relative to the second end piece in the circumferential direction of the shell; Equipped with The regulation mechanism is a slit portion formed in the first end piece and extending in the circumferential direction; a protrusion disposed on the second end piece and inserted into the slit; The slit portion is formed through the shell in a thickness direction, and is longer in a circumferential direction than in a vertical direction of the shell, The protrusion protrudes in the thickness direction of the shell and slides circumferentially within the slit portion.

2. the shell has a butt portion facing a tip end surface of the first end piece, The cranial shape correcting helmet according to claim 1 , wherein the second end piece is located outside the abutment portion.

3. The fixing mechanism includes: The first end piece has a first locking portion, The second end piece has a second locking portion, the first locking portion and the second locking portion are disposed on one side and the other side of each other in the circumferential direction, The cranial shape correcting helmet according to claim 1, wherein the first end piece and the second end piece are connected to each other via a connecting member that is detachably hooked onto at least one of the first engaging portion and the second engaging portion.

4. the shell has a deformation-permitting portion that faces a treatment area requiring bulging deformation of the skull and forms a space between the shell and the treatment area to permit the bulging deformation of the skull; 2. The cranial shape correcting helmet according to claim 1, wherein the deformable portion is provided with a palpation hole that enables the distance between the deformable portion and the treatment area to be measured by palpation.

5. A method for manufacturing the cranial shape correction helmet according to any one of claims 1 to 4, comprising: A method for manufacturing a cranial shape correction helmet, comprising a step of molding the shell using a 3D printer based on the outer shape of the skull to be corrected.

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