WO2018195602A1

WO2018195602A1 - Plagiocephaly helmets and methods for manufacturing plagiocephaly helmets

Info

Publication number: WO2018195602A1
Application number: PCT/AU2018/050385
Authority: WO
Inventors: David Phillips; Ken Shaw
Original assignee: Serkel Solutions Pty Ltd
Priority date: 2017-04-28
Filing date: 2018-04-27
Publication date: 2018-11-01

Abstract

A plagiocephaly helmet for a patient. The helmet comprises a body comprising a front portion and a rear portion and defining a chamber to receive a head of the patient; an openable seam disposed in a wall of the body between the front portion and the rear portion of the body to allow for selective adjustment of a circumference of the body; and an adjustable closure for selective coupling together of the front portion and the rear portion at the openable seam.

Description

Plagiocephaly helmets and methods for manufacturing plagiocephaly helmets

Technical field

Described embodiments generally relate to plagiocephaly helmets and methods for manufacturing plagiocephaly helmets. Some embodiments relate to a helmet for treatment of plagiocephaly, and in particular to a cranial remoulding helmet to be worn during treatment.

Background

Plagiocephaly is the most common craniofacial problem evident in infants less than 12 months old. Deformational plagiocephaly refers to a misshapen, uneven, or asymmetrical head shape. An example of plagiocephaly is shown in Figure 1.

In itself, plagiocephaly does not affect the development of a baby's brain, but if not treated, it may change their physical appearance by causing uneven growth of their face and head. Conventional treatment of moderate to severe cases of deformational plagiocephaly in infants involves the use of a plagiocephaly helmet. Use of a helmet enables cranial remoulding. In some instances, plagiocephaly helmets are manufactured by casting and modifying a plaster model of the infant's head - the fit of the helmet is therefore dependent on the ability of practitioners to accurately cast the plaster model. It is desired to address or ameliorate one or more of disadvantages associated with existing plagiocephaly helmets.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each claim of this application. Summary

Described embodiments provide a plagiocephaly helmet and methods for manufacturing a plagiocephaly helmet that enables treatment of plagiocephaly by providing adequate control over areas of bossing (bulging) while allowing adequate room for growth in the flattened areas of the infant's head.

Some embodiments relate to a plagiocephaly helmet for a patient, the helmet comprising: a body comprising a front portion and a rear portion and defining a chamber to receive a head of the patient; an openable seam disposed in a wall of the body between the front portion and the rear portion of the body to allow for selective adjustment of a circumference of the body; and an adjustable closure for selective coupling together of the front portion and the rear portion at the openable seam.

In some embodiments, the adjustable closure comprises an internal tongue arranged to span a gap disposed between the front portion and the rear portion at the openable seam. The internal tongue may extend along at least a substantial portion of the length of the seam. For example, the substantial portion may comprises at least 50% of the length of the seam or the substantial portion may comprise a full length of the seam. In some embodiments, the internal tongue extends across an entirety of the gap disposed between the front portion and the rear portion of the body. In some embodiments, the adjustable closure allows for coupling at a plurality of selective positions to allow for selective adjustment of a circumference of the body. The seam may extend from one edge of the body to another edge of the body.

In some embodiments, an opening is disposed at an upper portion of body to induce air-flow adjacent the head of the patient when worn. A plurality of apertures may be disposed about the body of the helmet.

In some embodiments, the helmet is manufactured using 3D printing.

In some embodiments, the helmet comprises a lightweight material.

In some embodiments, the helmet comprises a removeable liner disposed within the chamber of the helmet. Some embodiments relate to a method of manufacturing a plagiocephaly helmet for a patient, the method comprising: obtaining a 3D scan data of the patient's head; assessing requirements for the plagiocephaly helmet; modifying a computer aided design of the 3D scan data based on the assessed requirements; determining a digital construction of the plagiocephaly helmet based on the modified computer aided design; and 3D printing the plagiocephaly helmet in accordance with the digital construction. For example, the plagiocephaly helmet may comprises the plagiocephaly helmet of any of the described embodiments.

Some embodiments relate to a plagiocephaly helmet, wherein the helmet is manufactured using 3D printing.

By using 3D printing technology, customised helmets can be manufactured for patients, thereby ensuring each patient's helmet is shaped and configured to best fit the patient to address plagiocephaly. In this way, measurement errors and inaccurate casting of plaster models leading to ineffective and misfitting helmets are avoided or mitigated. The plagiocephaly helmet, according to embodiments, may include an overlap closure on at least one side of the helmet, such that, in use, the helmet wraps around the head of the patient. The overlap closure may include an internal tongue to help eliminate opening or overlap hypertrophy. A complementary slot and release tab may be provided to enable easy placement and removal of the helmet from the patient. The overlap closure may effectively reduce the incidence and complication rate of helmet opening or overlap hypertrophy.

Some embodiments relate to a plagiocephaly helmet for a patient, the helmet being configured to include air-flow paths adjacent the head of the patient, wherein the airflow paths are integrated in the helmet. In some embodiments, the plagiocephaly helmet is configured to include openings or air-flow paths adjacent the head of the patient, wherein the openings or airflow paths are integrated in the helmet. The openings or air flow paths may be customisable for the patient, and may take into consideration the size and shape of the patient's head to determine suitable shapes, sizes, patterns and positions for the openings or air flow paths. Described embodiments of the helmet may further include customisable fenestration thereby providing cooling properties of the helmet and a unique airflow design, thereby mitigating the chances of a patient overheating as a result of the helmet. The plagiocephaly helmet may be constructed from or composed of lightweight material, such as Nylon 11 or Nylon 12, for example. By selecting suitable lightweight materials, problems which arise with some existing plagiocephaly helmets made from relatively heavy materials including delaying motor skills such as lifting the head, may be mitigated. The plagiocephaly helmet may be constructed from or composed of relatively thin materials. For example, the plagiocephaly helmet of the described embodiments may have a thickness of approximately 3mm. Existing helmets generally have a thickness of existing helmets of about 10mm, which can be aesthetically unappealing and which can push the patient's neck into flexion when lying supine.

Some embodiments relate to a method of manufacturing a plagiocephaly helmet for a patient utilising 3D manufacturing, the method including obtaining a 3D digital scan of the patient's head, assessing requirements for a plagiocephaly helmet, modifying a computer aided design (CAD) of the 3D scan data based on the assessed requirements, determining a digital construction of the plagiocephaly helmet, and 3D printing the plagiocephaly helmet in accordance with the digital construction.

In some embodiments, assessing requirements for the need for a plagiocephaly helmet includes using a treatment algorithm involving scan data analysis and a subjective objective assessment plan (SOAP). The computer aided design modification of the 3D scan data may use existing software to create a normalised head shape. The normalised head data and a coded process developed by the applicant enables the digital construction of the patient's helmet.

Description of the drawings

Preferred embodiments will now be described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 is an illustrative representation of plagiocephaly;

Figure 2 is a right side view of a plagiocephaly helmet in accordance with some embodiments;

Figure 3 is a front view of the helmet of Figure 2;

Figure 4 is a left side view of the helmet of Figure 2; Figure 5 is a rear view of the helmet of Figure 2;

Figure 6 is a top view of the helmet of Figure 2;

Figure 7 is an underside view of the helmet of Figure 2;

Figure 8 is a right side view of a helmet, according to some embodiments; Figure 9 is left side view of a helmet showing a liner, according to some embodiments;

Figure 10A is close up view of an overlap closure of a helmet from inside the helmet, according to some embodiments;

Figure 10B is close up external view of the overlap closure of Figure 10A from outside the helmet, according to some embodiments; and

Figure 11 is a process flow diagram of a method of manufacturing a

plagiocephaly helmet for a patient, according to some embodiments.

Detailed description of embodiments

Cranial remoulding treatment is generally only effective when you have sufficient control over areas of bossing (bulging) of the head and allow adequate room for growth in the flattened areas of the head. Plagiocephaly helmets are not configured to squeeze the skull back into shape, but instead to redirect growth to fill out the flattened area. Once pressure from the weight of the head is relieved, the bone tends to immediately start to grow and the head rounds out. Referring to Figures 2 to 7, there is illustrated a plagiocephaly helmet 10 in accordance with some embodiments.

The helmet 10 comprises a body 11 having a front portion 12, a rear portion 14, a right side portion 16, and left side portion 17. The body 11 defines a chamber arranged to receive a head of the patient. In some embodiments, the right side portion 16 and left side portion 17 each comprise an extended or elongate side member, 18, 20, respectively, configured to sit in in front of the patient's ears, alongside the temple region, when the helmet 10 is worn by a patient. The helmet 10 may comprise an openable seam 23 that enables the helmet 10 to be comfortably fitted and secured to the patient, and adjusted as necessary. The openable seam 23 may be disposed at any position about the helmet 10 and may extend partially or fully between an opening 25 for receiving the patient's head and a top 24 of the helmet 10, or opening 26, as discussed below. For example, the seam 23 may extend between the openings 25 and 26 at a right side portion 16 and/or left side portion 17 of the helmet 10.

As best shown in Figures 2, 5, and 10A and 10B, the right side 16 of the helmet 10 includes an overlap closure 22, according to some embodiments, to bridge a gap formed or disposed at the openable seam 23, and for example, between the front portion 12 and the rear portion 14. For example, a gap may arise between the front portion 12 and the rear portion 14 as a result of the patient's head growing. The overlap closure 22 may be adjustable, allowing for selective positioning of the overlap closure 22 with respect to the front portion 12 and/or the rear portion 14 to accommodate such growth of the patient's head and/or to assist with fitting and securing the helmet to the patient's head, for example.

In some embodiments, the overlap closure 22 includes an internal tongue 27 to reduce helmet opening hypertrophy or overlap hypertrophy. Helmet opening or overlap hypertrophy is a condition that can arise as a result of using known prior art plagiocephaly helmets whereby the head tends to grow into a gap disposed between a front and rear portion of the helmet. The internal tongue 27 of the overlap closure 22 of the helmet 10 according to the described embodiments may be configured to bridge the gap (not shown) formed at the openable seam 23. The internal tongue 27 may have a comparable length to that of the helmet 10 at the openable seam 23. For example, the internal tongue 27 may extend from the opening 26 or the top 24 of the helmet 10 to the opening 25 for receiving the patients head. The internal tongue 27 may have sufficient length to extend about the head to bridge a gap (not shown) that may be permitted by the extent of reach of the overlap closure 22. In some embodiments, the internal tongue 27 may extend along at least a substantial portion of the length of the seam, such as at least 50% of the length of the seam or may extend along a full length of the seam. In some embodiments, the internal tongue may extend across an entirety of the gap disposed between the front portion and the rear portion of the body 11. In some embodiments, the internal tongue 27 may comprise material of similar type and thickness of that of the helmet 10. By providing the helmet 10 with an overlap closure 22 having an internal tongue 27, a gap that may become present between the front portion 12 and the rear portion 14 along the openable seam 23, for example, as a result of the growth of the patient's head, will be occluded or covered by the internal tongue 27 while the helmet 10 still accommodates overall growth of the circumference of the patient's head by suitable adjustment of the overlap closure 22.

The overlap closure 22 may comprise any suitable fastening means for fixing or connecting the front portion 12 and the rear portions 14 of the helmet 10 together. In some embodiments, an integrated Velcro™ slot may be provided to allow for growth adjustment and an integrated release tab may be provided to provide easy placement and removal of the helmet 10. The overlap closure 22 including the internal tongue (27) may assist in eliminating pinch points when fitting the helmet 10 to the patient. In some embodiments, the overlap closure 22 comprises a releasable zip tie arrangement (not shown) or releasable ligature arrangement (not shown) to allow for releasable securing of the overlap closure 22. In some embodiments, the overlap closure 22 comprises a strap (not shown), such as a strap comprising Velcro™, and a slot arrangement (not shown) to allow for releasable securing of the overlap closure 22. The overlap closure 22 may be configured to in structure and/or form to provide sufficient strength to bridge a gap (not shown) formed at the openable seam 23 and exert any necessary pressure on the head of a patient wearing the helmet 10.

It will be appreciated that the seam 23 and the overlap closure 22 including the tongue 27 may be provided on the left side portion 17 of the helmet as opposed to being provided on the right side portion 16 of the helmet 10 as shown in the figures, or indeed, in addition to the seam 23 and overlap closure 22 including the tongue 27 provided on the right side portion 16 of the helmet 10, a second seam (not shown) and overlap closure (not shown) including a corresponding second tongue (not shown) may be provided on the left side 14 of the helmet 10.

The top 24 of the helmet 10 may be provided with an opening 26 as shown in Figure 6. Opening 26 may provide air circulation and a cooling effect on the patient's head. In the embodiment illustrated, the helmet 10 effectively wraps around the patient's head and is secured at the overlap closure 22. It will be appreciated that the design of the helmet 10 is customisable to each patient's requirements and full-head helmets are within the scope of embodiments of the invention. As shown in Figures 2 to 7, the helmet 10 of the illustrated embodiment is provided with fenestration, or printed/moulded openings or windows 28. These openings 28 are fully customisable during the 3D printing process. In the embodiment illustrated, the openings 28 are a hexagonal shape and are arranged in a generally symmetrical manner around the helmet 10. In some embodiments, the openings 28 are circular or square or any other suitable shape and may be arranged in any suitable arrangement or pattern. Of course, 3D printing enables the choice of any shaped openings and arrangement thereof, for medical and/or aesthetic purposes. In an embodiment, a lightweight helmet 10 is provided wherein the openings 28 are formed to resemble a mesh or web-like structure, thereby providing optimised airflow and flexibility.

In some embodiments, the number, shape, configuration and/or arrangement of the openings 28 in the helmet 10 may be selected to optimise the rigidity of the helmet 10, the flexibility of the helmet 10 and/or airflow through the helmet 10, while maintaining the integrity of the helmet 10 and its ability to perform its function of mitigating deformational plagiocephaly. For example, characteristics such as a distance of the positioning of the openings 28 from edges of the helmet, relative positioning of the openings 28 to each other, whether the openings 28 are uniform or vary shape and size at different locations about the helmet 10, may be considered when determining an optimal helmet 10 design. In some embodiments, the helmet 10 may comprise one or more depressions or dimples (not shown) interspersed with the openings 28 which may assist with determining an optimal design.

The inclusion of openings 28 in the helmet 10 may provide significant medical advantages over known plagiocephaly helmets. For example, the openings 28 allow improved cooling properties of the helmet 10. The openings 28 enable air flow over the patient's skin, leading to increased skin evaporation in which heat is removed from the body so the patient will feel cooler. Creating improved air flow near the patient's head is particularly important since overheating is linked to an increased risk of Sudden Infant Death Syndrome (SIDS)

Furthermore, openings 28 reduce the weight of the helmet 10 by reducing the amount of material used in the helmet 10. Reducing the material used in the helmet 10 also means that the helmet 10 may be less rigid compared to conventional plagiocephaly helmets. Furthermore, helmets 10 according to described embodiments are flexible so as to easily place or remove the helmet from a patient's head while still providing the strength attributes required for a plagiocephaly helmet in use.

The helmet may be 3D printed, for example, using high performance additive materials, such as Nylon 11 or Nylon 12 or any other suitable polymer sharing lightweight and strength properties as will be appreciated by a person skilled in the art. Reduced weight helmets according to the described embodiments may be suitable for use by infants younger than 4 months in age, thereby reducing potential developmental delays in motor skills associated with conventional plagiocephaly helmets. Figure 8 shows a helmet 10' according to some embodiments. In some embodiments, the helmet 10' may further include a liner 30, as shown in Figure 9, to improve comfort and hygiene to the patient. The liner 30 may be custom laser cut utilising UV mapping. The liner 30 may be removable and/or may be formed from material that is one or more of breathable, washable, and durable. An example liner material is a 3 layer combination foam that is breathable, eco-friendly, washable, durable, latex-free, and neoprene free. In some embodiments, the liner 30 may be formed from or composed of bamboo. It will be appreciated that helmet 10 may be provided with a similar liner 30.

In some embodiments, the liner 30 may be attached to the helmet 10, 10' using a plurality of attachment 32 disposed about an inner surface of the helmet 10, 10'. In some embodiments, the attachments 32 comprise self-adhesive Velcro™, such as self- adhesive Velcro™ dots, which may be recessed into the internal surface of the helmet 10, 10'. Since the liner 30 is removable, potential build-up of bacteria on the interior of the helmet can be mitigated. The helmet 10, 10' of the described embodiments may be manufactured using 3D printing technology. Figure 9 is a flow diagram of a method 1100 of manufacturing a plagiocephaly helmet for a patient, according to some embodiments.

A 3D scan of a patient's head is performed, at 1102. For example, the 3D scan may be a laser scan using structured light to capture a 3D form in real time . The scan typically takes less than 60 seconds and may enable the creation of a custom cranial remoulding helmet that is accurate to about 0.5mm. In some embodiments, the patient is positioned onto a supported seating system with seat belt and a thin stocking with a face cut out is placed over the patient's head as the scanner does not read hair. A checked or patterned cape may be tied around the patient to enable easy scanning of the head only. A plurality of targets are placed or positioned on the patient's head. In some embodiments, targets are places on one or more of (i) the temporal bone superior to the tragus (left and right); (ii) frontal bone superior to the glabella; (iii) each side of the parietal bone; and (iv) on the occipital bone. For example, by targeting the 3D scan on these particular targets, the resulting scan data allows for improved assessment of requirements for the plagiocephaly helmet.

Requirements for the plagiocephaly helmet are assessed, at 1104. In some embodiments, assessing requirements for plagiocephaly helmet includes using a treatment algorithm involving scan data analysis and a subjective objective assessment plan (SOAP). In some embodiments, a subjective assessment of the SOAP may be based on information relating to the patient including one or more of the following: child's age, number of weeks at birth; type of birth and pregnancy; usual sleeping position for the child; type of equipment the child uses (i.e., strollers, baby carriers etc.); age abnormal head shape was noted; if there have been any head shape changes since this time; if torticollis is present and if so if it is being treated; other treatments tried; and current developmental level. The subjective assessment may be performed before the 3D scan is performed.

In some embodiments, an objective assessment of the SOAP may be based on information relating to the patient including one or more of the following: the child's facial symmetry (i.e larger eye, fuller cheek, head slope etc.); the child's ear alignment (i.e anterior/posterior shift or medial/lateral shift); whether or not the fontanelle is palpated; bossing; and flattened areas. The objective assessment may be performed before the 3D scan is performed.

A computer aided design of the 3D scan data ( a model) is modified based on the assessed requirements, at 1106. The model may be manipulated to arrive at a helmet design tailored specifically for the patient to achieve a desired head-shape end-state. For example, the desired head-shape end-state for a particular patient may be determined from the assessed requirements. In some embodiments, the model may be manipulated to provide adequate control over areas of bossing (bulging) while allowing adequate room for growth in the flattened areas of the patient's head. In some embodiments, rectification software, such as Rodin4D or other tools provided by Rodin SAS or other providers, may be used to modify the 3D scan based on the assessed requirements.

A digital construction of the plagiocephaly helmet is determined based on the modified computer aided design, at 908. In some embodiments, determining the digital construction comprises merging a determined fenestration pattern onto a helmet surface of the modified computer aided design. In some embodiments, the determining the digital construction comprises optimising one or more of (i) ventilation capacity, (ii) weight, (ii) structural strength and (iv) aesthetic variable to provide an improved helmet 10, 10'. The digital construction may comprise an STL file. In some embodiments, an STL editor, such as Magics, is employed to create the digital construction. A plagiocephaly helmet in accordance with the digital construction is printed, at 910.

Aside from the advantages of the physical attributes of the helmet of embodiments described above it will be appreciated that the helmet is visually superior and more aesthetically appealing and may result in increased acceptance by patients thereby creating better clinical results. It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

1. A plagiocephaly helmet for a patient, the helmet comprising: a body comprising a front portion and a rear portion and defining a chamber to receive a head of the patient; an openable seam disposed in a wall of the body between the front portion and the rear portion of the body to allow for selective adjustment of a circumference of the body; and an adjustable closure for selective coupling together of the front portion and the rear portion at the openable seam.

2. The plagiocephaly helmet of claim 1, wherein the adjustable closure comprises an internal tongue arranged to span a gap disposed between the front portion and the rear portion at the openable seam.

3. The plagiocephaly helmet of claim 1 or claim 2, wherein the internal tongue extends along at least a substantial portion of the length of the seam.

4. The plagiocephaly helmet of any one of the preceding claims, wherein the substantial portion comprises at least 50% of the length of the seam.

5. The plagiocephaly helmet of any one of the preceding claims, wherein the substantial portion comprises a full length of the seam.

6. The plagiocephaly helmet of any one of the preceding claims, wherein the internal tongue extends across an entirety of the gap disposed between the front portion and the rear portion of the body.

7. The plagiocephaly helmet of any one of the preceding claims, wherein the adjustable closure allows for coupling at a plurality of selective positions to allow for selective adjustment of a circumference of the body.

8. The plagiocephaly helmet of any one of the preceding claims, wherein the seam extends from one edge of the body to another edge of the body.

9. The plagiocephaly helmet of any one of the preceding claims, wherein an opening is disposed at an upper portion of body to induce air-flow adjacent the head of the patient when worn.

10. The plagiocephaly helmet of any one of the preceding claims, wherein a plurality of apertures are disposed about the body of the helmet.

11. The helmet of any one of the preceding claims, wherein the helmet is manufactured using 3D printing.

12. The helmet of any one of the preceding claims, wherein the helmet comprises a lightweight material.

13. The helmet of any one of the preceding claims, further comprising a removeable liner disposed within the chamber of the helmet.

14. A plagiocephaly helmet for a patient, the helmet being configured to include air-flow paths adjacent the head of the patient, wherein the airflow paths are integrated in the helmet.

15. A plagiocephaly helmet, wherein the helmet is manufactured using 3D printing.

16. A method of manufacturing a plagiocephaly helmet for a patient, the method comprising: obtaining a 3D scan data of the patient's head; assessing requirements for the plagiocephaly helmet; modifying a computer aided design of the 3D scan data based on the assessed requirements; determining a digital construction of the plagiocephaly helmet based on the modified computer aided design; and

3D printing the plagiocephaly helmet in accordance with the digital construction.

17. The method of claim 14, wherein the plagiocephaly helmet comprises the plagiocephaly helmet of any one of claims 1 to 15.