Field of the Invention

The present invention relates to the field of medical devices for treating deformed skeletal parts. More particularly, the invention relates to a cranial orthosis and an apparatus for monitoring torticollis.

Background of the Invention

Positional Skull Deformity (also known as flat head syndrome) is a common condition in infants characterized by asymmetrical or symmetrical posterior occipital flattening. The infant's head is soft and malleable in the first months of life and is therefore susceptible to deformation due to external mechanical pressure. In more severe cases, asymmetry appears in additional cranial areas, which affects also the facial structure (Gary F. Rogers: "Deformational Plagiocephaly, Brachycephaly, and Scaphocephaly", Part I: Terminology, Diagnosis, and Etiopathogenesis). The most common skull deformities are plagiocephaly, brachycephaly and scaphocephaly.

Congenital Muscular Torticollis (CMT) is a postural deformity evident shortly after birth, typically characterized by lateral flexion/side bending of the head to one side and cervical rotation/head turning to the opposite side due to unilateral shortening or imbalance of the sternocleidomastoid muscle. Torticollis is often associated with plagiocephaly (Cabrera-Martos et al.: "Impact of Torticollis Associated with Plagiocephaly on Infants' Motor Development", the Journal of Craniofacial Surgery: January 2015 - Volume 26 - Issue 1 - p 151-156).

The prevalence of plagiocephaly has increased significantly since 1992, due to the American Academy of Pediatrics (AAP) recommendation to lay infants in a supine sleeping position, in order to reduce Sudden Infant Death Syndrome (SIDS). In recent years, the reported rate of plagiocephaly for infants aged up to a year is 16-48%.

The presence of plagiocephaly is statistically associated with a variety of delayed developments (which may be cognitive, motor and linguistic developments), that should be treated. Also, plagiocephaly has substantial esthetic implications regarding the skull structure and facial features. Such implications exist not only in the early years, but also during adolescence (Di Rocco et aL: "Prevalence and severity of positional plagiocephaly in children and adolescents", Acta Neurochirurgica volume 161, pages 1095-1098 (2019). Sometimes, plagiocephaly lapses during the early years and sometimes remains until adolescents.

It is an object of the present invention to provide a cranial orthosis that is suitable to treat plagiocephaly, brachycephaly, and scaphocephaly, and to minimize discomfort to the infants and their families.

It is an additional object of the present invention to provide a cranial orthosis that is cost effective.

It is an additional object of the present invention to provide a cranial orthosis device that is suitable to assist in diagnosing and treating torticollis.

Other objects and advantages of the invention will become apparent as the description proceeds.

Summary of the Invention

A cranial orthosis configured to induce cranial remodeling to achieve symmetry of the skull, as well as adequate proportions between the head width and length, for infants suffering from positional skull deformities comprises a headpiece adapted to encircle, and to be secured to, the skull of an infant suffering from positional skull deformity in such a way that contact between a flattened occipital area of the infant and a flat surface on top of which the infant is lying is prevented so that unrestricted occipital growth (or other places) is able to be induced, wherein said headpiece is adjustable to take into account cranial growth of the infant and to redirect the head growth. The headpiece is capable of adjusting the infant's head growth, to improve symmetry and obtain adequate proportions.

A diagnostic therapeutic apparatus for detecting the magnitude and location of the forces applied to the infant's skull (for example, during supinely orientation) comprises a headpiece configured with a posterior section adapted to encircle, and to be secured to, a posterior region of the skull of a patient, and a sensor module in force transmitting relation for example, with the posterior section (or in other locations along the internal surface of the adjustable cranial orthosis that allow monitoring the forces applied to the infant's skull), to continuously measure data related to mechanical pressure to which the skull of the patient is exposed. The diagnostic product may be adapted to obtain early diagnosis and treating of torticollis and may further comprise an electronic module with an orientation sensor (such as a gyroscope or a 3-D accelerometer), memory and operating software that continuously measures and records the instantaneous orientation of the infant's head (for example, while lying on his back), as well as changes in the orientation over time.

The diagnostic product may further comprise:

- arched pressure gauge sensors which measures and records the pressure applied to the infant's head over time;

- a microcontroller or any other type of processor for processing and displaying the recorded data regarding the applied pressure.

Optionally, the measured data may be stored and processed in a computational cloud, for allowing display to end users and access by other applications.

Brief Description of the Drawings

In the drawings:

- Fig. 1 is a perspective view of an embodiment of adjustable cranial orthosis, when assembled;

- Fig. 2 is a perspective view of the adjustable cranial orthosis of Fig. 1, when an intermediate arcuate piece of the posterior section and a protective sheath of the anterior section are removed;

- Fig. 3 is a perspective view of the adjustable cranial orthosis of Fig. 1, when an intermediate arcuate piece of the posterior section and a protective sheath of the anterior section are removed and the padding member is shown to be transparent;

- Fig. 4A is a side view of the cranial orthosis of Fig. 1, schematically illustrating angular and lengthwise adjusting modes;

- Fig. 4B is an anterior view of the cranial orthosis of Fig. 1, schematically illustrating a widthwise adjusting mode;

- Fig. 4C is a plan view of the cranial orthosis of Fig. 1, schematically illustrating lengthwise and widthwise adjusting modes;

- Fig. 5 is an exploded view of an embodiment of a skull securable diagnostic product; - Fig. 6 is a schematic illustration of a sensor module used in conjunction with the diagnostic apparatus of Fig. 5;

- Fig. 7 illustrates another embodiment, according to which the anterior section (shown in Fig. 1) of the adjustable cranial orthosis comprises an orientation sensor;

- Fig. 8 is a perspective view of another embodiment of a cranial orthosis secured to an infant's skull, when adjusted to a minimum length;

- Fig. 9 is a perspective view of the orthosis of Fig. 8 secured to an infant's skull, when adjusted to a maximum length;

- Fig. 10A is a perspective view of an exploded view of the orthosis of Fig. 8;

Fig. 10B illustrates an incision in the posterior protective sheath that allows inserting the posterior support frame;

- Fig. 11 is a perspective view of the orthosis of Fig. 8 when assembled without the protective sheaths and when unsecured to an infant's skull;

- Fig. 12 is a horizontal cross sectional view of the orthosis of Fig. 8, when adjusted to a minimum length;

- Fig. 13A is a horizontal cross sectional view of the orthosis of Fig. 8, when adjusted to a maximum length; and

- Fig. 13B illustrates posterior section of Fig. 13A, following further displacement of the two L-shaped elements laterally, to gain extra width.

Detailed Description of the Invention

The cranial orthosis is a therapeutic headpiece that is adapted to encircle the skull of an infant suffering from positional plagiocephaly or brachycephaly or scaphocephaly and to induce cranial remodeling to achieve symmetry and adequate proportions, by providing passive protection to the circumferential outline of the infant's head. The headpiece will be coupled to the prominent areas, while leaving a gap in the flat area, in order to redirect the head growth . The cranial orthosis is adjustable to take into account the growth of the infant (in order to fit the various shapes and size range of infants), and has a posterior section (the posterior section may also be rigid, flexible or spring-like) that is configured, in one embodiment, with one or more sagitally spaced arcuate pieces following the contour of a normal symmetric skull, as well as an anterior section that is securable with the posterior portion and configured with a forehead engageable member. According to one embodiment, the headpiece is devoid of any material connecting the anterior portion to the posterior portion along the crown of the skull to its vertex, and is therefore surprisingly light, significantly reducing its weight. The infant will be able to comfortably perform activities when lying on its stomach even though the headpiece is secured to the infant's cranium. According to another embodiment, the headpiece may include lightweight and soft material that will be added to the area along the crown of the skull, for padding to prevent pressure points and falling of orthosis to neck area.

Fig. 1 illustrates an embodiment of adjustable cranial orthosis 10. Cranial orthosis 10 comprises anterior section 5 and posterior section 15.

Anterior section 5 is configured with a rounded U-shaped support frame 7 made from a structurally strong and relatively lightweight material, such as aluminium and rigid, or reinforced plastic material, and covered by a protective sheath, such as made of a hard plastic for the center piece and a textile or other soft / flexible material for the side parts. As support frame 7 is intended not to be in contact neither with the forehead nor with the temples of the infant, forehead engageable member 3 provided with padding is attached to the posterior side of the transversally extending portion of support frame 7. These lightweight parts (that may be covered in a soft fabric at all stages of use) are adjustable, and are comprised of 2 L-shaped parts, that glide over each other for adjustability.

Alternatively, U-shaped anterior section 5 may be configured as a flexible strap.

Posterior section 15 has three rigid arcuate pieces 16-18, for example made of a hard and lightweight, yet flexible, plastic material such as polypropylene, High-density polyethylene (HDPE), acetyl and polycarbonate, and a padding member 19 attached to the inner side of arcuate pieces 16-18 for increased comfort when cranial orthosis 10 is worn. Alternatively, the plastic material may be combined with spring steel strips. Intermediate arcuate piece 17 anteriorly protrudes from, and is sagitally interposed between, arcuate pieces 16 and 18. The padding member may also be designed in such a structure and shape, so as to enable adjustment to prevent movement and slipping of device towards the neck. It may be attached also to the anterior section and be adjustable together with anterior and posterior sections. The padding may have pockets or other means for attaching spacer pads, to improve stability, fit and comfort. Intermediate arcuate piece 17 has two transversally separated anteroposterior portions, each of which is coupled and collinear with a corresponding anteroposterior portion of the support frame sheath, and an arcuate portion extending between the two anteroposterior portions. Support frame 7 and intermediate arcuate piece 17 are preferably covered with a common protective lining.

It will be appreciated that posterior section 15 may have any other number of arcuate pieces.

The configuration of padding member 19 is shown in Fig. 2. Padding member 19 has two relatively narrow temple engaging portions 21 that are attached to a corresponding anteroposterior portion 8 of the support frame of anterior section 5 and that slightly protrude superiorly therefrom. An arcuate occipital portion 23 of increased width extends continuously from one temple engaging portion 21 to another, and is adapted to engage the back of the head from the vertex at the top of the head to the nape of the neck proximate to the nuchal ridge, although it is primarily adapted to induce cranial remodeling in response to the presence of positional plagiocephaly in an occipital area. Padding member 19 may be made of hypoallergenic, biocompatible, and breathable foam that is soft and pleasant when contacted by the infant.

Also shown is an adjustment key 31 for tightening a nut 33, or other suitable fastener, on anterior section 5 or on posterior section 15. The key may be designed to be unintimidating and may be made smaller and integral in the orthoses. The adjustment mechanism may be an integrated mechanism that will enable adjustment of the width and possibly the length of the device, by turning a built in mechanism and a knob, such as in a molding helmet.

As shown in Fig. 3, an insert 26, e.g. an elliptical and planar insert made of steel or may have a plastic structure and possibly made from a reinforced plastic. The insert 26 is integrally formed with padding member 19, and extends anteroposteriorly within both temple engaging portion 21 and occipital portion 23 and is of substantially the same height as anteroposterior portion 8 of support frame 7. A screw connected to insert 26, such as by welding, passes through a groove 9 provided in anteroposterior portion 8 of support frame 7 and is used for adjustment purposes by securing nut 33 threadedly fastened with the screw. It will be appreciated that other adjustment means may be employed as well. Support frame 7 is shown to have two transversally extending portions 12 and 13, each of which formed with a groove 11. The two transversally extending portions 12 and 13 are adjustably connected to each other by a screw and nut arrangement cooperating with the grooves 11. The screw may be connected to a steel insert integrally formed in forehead engageable member 3. Alternatively, a linear rail &cog wheel mechanism with a knob may be used to enable a symmetrical adjustment movement of portions 12 13.

A sagitally extending and narrow support appendage 34, which may be perpendicular to insert 26, may be fixedly attached, such as by a screw and nut arrangement, to the outer side of insert 26. Appendage 34, when protruding beyond insert 26, is used for facilitating angular displacement of arcuate pieces 16 and 18. A curved brace (not shown) pivotally connected to a corresponding protruding extremity of appendage 34 in such a way that the brace is capable of undergoing restricted rotation is inserted within, and attached to, the arcuate piece. Thus the arcuate piece is able to be fixed in position to provide location-specific support to the infant after the brace is pivoted.

Padding member 19 is shown to be configured with a compressible backing element 1 that slightly protrudes outwardly from occipital portion 23 and that is positioned between arcuate pieces 16 and 18. Padding may be easily removed and attached for washing or fitting a thicker padding. Alternatively, the padding may have pockets for adding additional padding selectively. These pockets may be used to add pads in order to fill unwanted gaps and improve stability and reproducibility/repetitiveness for repositioning after washing.

Backing element 1 is used to support the intermediate arcuate piece and follows the arcuate contour of occipital portion 23. Since backing element 1 curves together with occipital portion 23 close to the interface with temple engaging portion 21, a posterior portion 29 of the substantially planar anteroposteriorly extending insert 26 that protrudes from appendage 34 is slightly spaced from the curved backing element 27. The spacing between backing element 1 and posterior portion 29 is sufficient for the insertion of a wall of the hollowed intermediate arcuate piece therebetween, when being coupled with posterior portion 29.

Various possibilities of adjusting cranial orthosis 10 are schematically illustrated in Figs. 4A-B. Widthwise adjustment mechanism will enable symmetrical change on both the left and right side of the device. Adjustment of the width of the device changes the curvature of the arcuated pieces, which are flexible in order to enable the curvature and strong enough to hold the weight of the head.

Arcuate pieces 16 and 18 are able to be angularly adjusted about the transversal axis by which a curved brace is pivotally connected to a sagitally extending appendage, as indicated by arrow 32. The rigid arcuate pieces that are secured to the round back of the head prevent contact between a flattened occipital area and the flat surface on top of which the infant is lying. As the cause of the cranial deformity is averted, unrestricted occipital growth in response to rapid brain growth is made possible. Thus the cranial bones are pushed outward while the infant's head rests in the concave space defined by the arcuate pieces 16-18 and the padding member until the normal rounded cranium structure is achieved.

The length of the orthosis is able to be adjusted by displacing a temple engaging portion 21 of the padding member relative to the corresponding anteroposterior portion 8 of the support frame and securing the nut, as indicated by arrow 34. The width of the orthosis is able to be adjusted by displacing the two transversally extending portions of the support frame relative to one another and securing the nut, as indicated by arrow 36. Since the dimensions of the cranium change during periods of occipital growth, the length and width of the orthosis generally have to be continuously adjusted to ensure suitable securement of the anterior and posterior portions.

Figs. 8-13 illustrate another embodiment of a cranial orthosis 80, which facilitates adjustment in response to both lengthwise and widthwise skull growth.

As shown in Fig. 8, cranial orthosis 80 comprises anterior section 85 and posterior section 105 that are releasably coupled together and that are adapted to be secured to the skull 81 of an infant. Each of anterior section 85 and posterior section 105 comprises a support frame, a protective sheath by which the support frame is enclosed, and a padding element with which the protective sheath is engaged. The type of material from which each of the elements is made may be similar to that of cranial orthosis 10 of Fig. 1, with the exception of the posterior support frame, which is structurally strong and flexible to at least a certain extent, for example made of plastic material such as polypropylene, HDPE, acetyl and polycarbonate. Posterior section 105 comprises two arcuate pieces 101 and 102 that are angularly spaced from each other and are adapted to follow, and to be continuously secured to, the rounded contour of skull 81, which is presently symmetrically shaped or intended to be symmetrically shaped following the unrestricted occipital growth that is able to be induced by cranial orthosis 80. At each lateral side of skull 81, the two arcuate pieces 101 and 102 combine together at interface portion 107 to define a Y- shaped structure. Interface portion 107 in turn extends continuously to the corresponding anteroposterior portion 108.

Anteroposterior portion 108 is formed with an aperture, e.g. elliptically shaped, a border 109 of which serving to limit translational displacement of a protuberance 104 connected to a support frame insert 103, which is visible through the aperture. Protuberance 104 is shown to be positioned at the extreme anterior end of border 109 corresponding to a minimal orthosis length. As skull 81 becomes enlarged, protuberance 104 and insert 103 are displaced posteriorly to accommodate the enlarged skull dimensions, until arcuate pieces 101 and 102 are once again secured to the skull, In Fig. 9, protuberance 104 is shown to be positioned at the extreme posterior end of border 109, causing posterior section 105 to become spaced from skull 81.

Fig. 10A illustrates an exploded view of orthosis 80, including the anterior support frame 93, the anterior protective sheath 94, the anterior padding element 96, the posterior support frame 112, the posterior protective sheath 114, and the posterior padding element 116.

Anterior padding element 96 and posterior padding element 116 are shown to be in close proximity to each other, defining the concave space 111 within which the infant's skull is positionable in order to undergo cranial remodeling. The inner face of both anterior padding element 96 and posterior padding element 116 facing towards concave space 111 is completely smooth to increase comfort of the infant. The outer face of anterior padding element 96 and posterior padding element 116 facing away from concave space 111 is each formed with upper and lower outwardly protruding portions that facilitate suitable positioning of the corresponding support frame or the corresponding enclosing protective sheath. Posterior padding element 116 may comprise an upper lacing 87A and a lower lacing 87B for fastening the padding element 116 to the infant's head. Each lacing is terminated with a fixation element 95 (such as a hook or a Velcro fastener strap), for fixating each lacing edge to the external surface of the padding element 116. Fig. 10B illustrates the posterior protective sheath 114, with an incision 119 that allows inserting the posterior support frame 112, into the posterior protective sheath 114, such that it will wrapped before attachment to the posterior padding element 116.

As shown for example in Fig. 11, arcuate pieces 91 and 92 of the posterior support frame are positioned above and below, respectively, lower protruding portion 118 of posterior padding element 116 while generally being in abutting relation therewith. While upper protruding portion 117 of posterior padding element 116 extends throughout the circumferential length of the latter, lower protruding portion 118 extends only along a limited length of posterior padding element 116 so as not to interfere with the positioning of interface portion 107 of the posterior support frame.

Anterior support frame 93 is U-shaped and configured with rectilinear forehead engageable member 88 from which anteriorly protrudes a sensor module 142 and with two opposed L-shaped elements 89A and 89B that are each slidably and adjustably introducible into corresponding sockets 86A and 86B, respectively, of forehead engageable member 88 for widthwise adjustment. The transversally extending portion of each of the two L-shaped elements 89A and 89B is securable to forehead engageable member 88, for example with thin securing element 123 (Fig. 12). The anteroposterior portion 84 of each L-shaped element 89 is formed with an aperture 83 that permits displacement of protuberance 104. L-shaped elements 89A and 89B are engaged by a cog-wheel 89C, such any displacement of one of them in its corresponding socket will cause movement of the other L-shaped element in the opposite direction, as shown in Fig. 12 (so as to ensure a symmetrical configuration of the U-shaped anterior section 5).

As shown in Fig. 12, each anterior anteroposterior portion 84 comprises a thin hollow chamber having opposed walls 127 and 128. The spacing between walls 127 and 128 is sufficiently large to receive and secure a posterior support frame insert 103. Posterior support frame insert 103 is introduced via a posterior opening of the corresponding anteroposterior portion 84. When insert 103 is inserted within anteroposterior portion 84 to a maximum extent as shown, the circumferential length of posterior section 105 able to be secured to the infant's skull, particularly arcuate piece 92, is limited, and therefore resists expansion of the infant's skull.

After insert 103 has been introduced into the corresponding anteroposterior portion 84, protuberance

104 is connected to the insert, for example threadedly connected via a threaded aperture formed in the insert, and is caused to be engaged with a border 129 of an inner aperture formed in wall 128 and thereby being prevented from being displaced. The engagement with border 129 is sufficiently strong so that anterior section 85 and posterior section 105 are able to remain engaged together even when not secured to an infant's skull, as shown in Fig. 11.

Once protuberance 104 is slightly loosened, it is free to be displaced anteroposteriorly along the space between borders 109 and 129, together with insert 103.

Protuberance 104 may be connected to insert 103 by other means well known to a person skilled in the art.

Anterior protective sheath 94 and posterior protective sheath 114 are able to introduced over anterior support frame 93 and posterior support frame 112, respectively, through bottom and/or upper slits formed in each protective sheath, after anterior section 85 and posterior section 105 have been coupled together, or alternatively prior to being coupled together. Anterior protective sheath 94 and posterior protective sheath 114 are able to be coupled together in conjunction with means well known to a person skilled in the art when one hollow end member 131 of one of them is inserted within a hollow end member of the other.

Fig. 13A illustrates posterior section 105 when retracted from anterior section 85 relative to the position shown in Fig. 12, following displacement of the protuberance. Only a fraction of the length of insert 103 is received in anteroposterior portion 84, and therefore interface portion 107 and the remaining length of insert 103 are unrestricted. The circumferential length of posterior section 105 that is able to be secured to the infant's skull is significantly increased relative to that shown in Fig. 12 by virtue of the unrestricted insert 103, and therefore supports expansion of the infant's skull both in a lengthwise and widthwise direction.

Fig. 13B illustrates posterior section of Fig. 13A, following further displacement of the two L-shaped elements 89A and 89B laterally, with respect to each other, so as to gain extra width (in addition to the extra length gained as illustrated in Fig. 13A) to receive a larger infant's head. In another embodiment, the headpiece of Fig. 1, Fig. 8 or any other skull-exposed headpiece functions as a diagnostic and therapeutic product (or apparatus) which is adapted to measure data related to the head orientation and mechanical pressure to which the skull of the infant is exposed. It is not required to monitor the head orientation along the entire treatment period, but only along a predetermined time period (about 5-15 min.). Also, the electronic system will be designed to be removed and installed easily from the therapeutic device, as needed.

Such data helps to detect SCM muscle imbalance that is a cause of torticollis, or a head positional preference. The diagnostic product may be in addition to the therapeutic product (that is aimed to treat skull deformations) while being provided in the same orthosis, or alternatively may be independent of the therapeutic product. An orientation sensor (described later on) that is capable of diagnosing torticollis, can be an add-on device or a stand-alone device.

Fig. 5 schematically illustrates diagnostic product 40, which comprises a sensor module 42 fitted, for example, between intermediate arcuate piece 17 and padding member 19 and in force transmitting relation therewith (of course, the sensor module 42 may have different locations along the internal or external surface of the headpiece 10). Sensor module 42 comprising an array of sensors preferably has an arcuate configuration, similar to that of intermediate arcuate piece 17 and padding member 19, and may sagitally protrude from intermediate arcuate piece 17 so as to be additionally in force transmitting relation with one or more of arcuate piece 16 and arcuate piece 18.

Sensor module 42, which may comprise electronic or chemical sensors which are deployed along all regions of contact with the infant's skull, is suitable to continuously measure the mechanical loading on different regions of the skull 47 of a patient secured between the U-shaped anterior section 5 and the posterior section that includes for example arcuate piece 17, and to detect information regarding the amplitude, distribution and duration of accumulative mechanical pressure at each of these skull regions.

In another embodiment, sensor module 42 may be embedded within one or more of arcuate pieces 16-18. The shape and mechanical properties of the arcuated pieces 16-17-18 (shown in Fig. 1), as well as 103 and 107 (shown in Fig. 8), enable changing the curvature of the pieces according to the adjusted width of the device. The actuated pieces 16-18 change their curvature due to their flexibility and at the same time, they have sufficient strength in order to maintain their shape under the weight of the infants head and prevent collapse, and hence, allow smooth rolling the infant's head.

Also, adjusting the curvature of the pieces allows accurate fitting of the arcuated pieces 16-17-18 to the size of the infant's head. These features keep the symmetrical gap that faces the flat areas and provide an orthosis that is much more versatile than molding helmets due to a continuous adjustment with fixation capability.

The orthosis provided by the present invention solves the flat head syndrome problem, by mainly supporting the perimeter of the infant's head.

The arcuate shape enables on one hand to facilitate space for symmetrical growth of the skull in the inner side, and on the other hand the outer side of the actuated pieces enable smooth rolling movement of the infant's head on the bed surface, without inhibition.

As shown in Fig. 6, sensor module 42 comprises an array of distributed sensors 44 for detecting the force exerted at a corresponding skull region, a microcontroller or any other type of processor 46 for receiving and processing the data signals derived from each sensor 44, and a battery 49 for powering processor 46 and each sensor 44.

In another embodiment, headpiece 10 of Fig. 1 may be modified so as to be a therapeutic product in addition to the previously described diagnostic product. Following determination that the infant is diagnosed with torticollis, a health practitioner may couple a resistance applying element, such as a rigid patch, to a selected region between two of the arcuate pieces 16-18. The selected region to which a patch is coupled is generally contralaterally located with respect to a cervical muscle found to be weakened. This weakened muscle is consequently forced by the patch to be tensioned until the head achieves a balanced condition.

Fig. 7 illustrates another embodiment, according to which the anterior section 5 (shown in Fig. 1) of the adjustable cranial orthosis 10 comprises an orientation sensor 71, which is insertable into a mating housing 72. By suitably processing thedata signals derived from each sensor 44, the presence of asymmetrical cervical muscles often associated with torticollis is able to be determined, so that a therapeutic treatment for this condition is able to be developed, even prior to manifestation of plagiocephaly. Additionally, analysis of the received signals during the therapeutic treatment (which are monitored for a predetermined period every predetermined time) is able to indicate an improvement of the diagnosed torticollis and a gradual achievement of symmetrical musculature to promote a full range of head motion, even before a change in roundness of the skull is noticeable. Monitoring of the orientation allows improving the decisions regarding the next therapeutic steps to be taken and the determination of the required treatment period.

Housing 72 may be attached to the upper face of the anterior section 5 using a connector, such as a spring-loaded pin (also known as a "pogo pin"). Orientation sensor 71 may comprise an electronic module with a gyroscope or a 3-D accelerometer, memory and operating software that continuously measures and records the instantaneous orientation of the infant's head while lying on his back, as well as changes in the orientation over time. The recorded data may be transmitted to a remote server and stored on that server or uploaded for storage in a computational cloud. The stored data may be used later for clinical and research purposes.

The adjustable cranial orthosis 10 may also comprise an arched pressure gauge sensor 35 which measures and records the pressure applied to the infant's head over time. A microcontroller or any other type of processor are added and used for processing and displaying the recorded data regarding the applied pressure. The measured data may be transmitted to the orientation sensor 71 via a wired connection74, for storage and transmission to the remote server or to the computational cloud.

According to another embodiment, the orientation sensor 71 is adapted to perform early diagnosis of torticollis and to assist the treatment of torticollis. This is done by monitoring and reporting data regarding the orientation of the infant's head with respect to his body and the surrounding environment. This way, it will be possible to put the adjustable cranial orthosis device 10 (which functions as a diagnostic apparatus) on the infant's head for a predetermined (short) time (e.g., for few minutes) and collect the data. Then, the collected data is stored and analysed, so as to visually illustrate the results to parents and the medical team. According to another embodiment, a pressure sensor may be inserted into the mating housing 72. The pressure sensor may comprise for example, a strain gauge or a piezoelectric transducer, and is adapted to monitor and report data regarding the magnitude of forces that are exerted at different skull regions as a function of time. Then, the collected data is stored and analysed, so as to visually illustrate the results to the medical team. Measuring the magnitude of forces that are exerted at different skull regions increase the safety while using the cranial orthosis 10 and prevents exceeding the maximum allowable forces (as defined by health authorities).

While some embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried out with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art, without exceeding the scope of the claims.