DESC:
TECHNICAL FIELD
[0001] The present invention relates generally to biomedical devices and more specifically relates to an instrument to allow three-dimensional determinations of cervical neck movements including lateral flexion, lateral rotation, and sagittal flexion and extension.
BACKGROUND ART
[0002] Neck movement is a complex movement as neck movement involves the engagement of eight cervical vertebrae. Further, shoulder movements also affect neck movements. However, the normal movements of the neck get affected due to several ailments such as, but not limited to, physical trauma, rheumatological diseases, muscle or bone ailments. The normal neck movements may also be affected post neck surgery or radiation therapy. Getting measurement of the neck movement in various axes helps to quantify the morbidity/ limitations posed by the aforementioned diseases and therapies. The benefit of interventions like surgery, physiotherapy, or medications for restricted neck movement can also be quantified based on objective measurement.
[0003] In that regard, several devices for measuring the angular movements of the spine have been developed, some of which have been listed below.
[0004] CN209679409U discloses a head angle measuring instrument for cervical part dystonia parting information, which comprises a vertical device and a head-mounting device, wherein the head-mounting device has a multi-plane measuring device, pointers, a head helmet, a tightening rope, a prolonging rod, a vertical chain, and a trigger rod. The helmet top is connected with the multi-plane protractor via the trigger rod. One end of the prolonging rod is connected to a sagittal view protractor of the multi-plane protractor. The vertical device is formed by a pedestal, a semi-circular protractor, and a rack rod part, in a manner, that the semi-circular protractor is connected to the rack rod part via a slide block.
[0005] Raya R, Garcia-Carmona R, Sanchez C, et al. "An Inexpensive and Easy

to Use Cervical Range of Motion Measurement Solution Using Inertial Sensors", Sensors (Basel), 2018;18(8):2582, Published2018 Aug 7, describes the development of wearable inertial sensors which are composed of: (a) two wearable wireless MEMS-based inertial devices, (b) a recording and report generation software application and (c) a measurement protocol for assessing CROM.
[0006] CN110916869A discloses a kyphosis correction frame with a cervical traction mechanism relating to a cervical traction kyphosis correction device. The rear and lower ends of a semicircular rod on one side and a semicircular rod on the other side are respectively arranged on both sides of the upper end of the back rod. The lower part of the rod is connected to the middle part of the waist belt, the lower end of the support rod is connected to the upper end of the back rod, the upper end of the support rod is connected to the middle of an inclined plate, and both ends of the inclined plate are respectively attached to the upper part of the belt. The lower part of the belt is provided with a chin rest, the two semi-circular rods of the present invention hook the front of the shoulders or the chest to obtain the correction request of the kyphosis, and at the same time, the belt on the inclined plate of the support rod is used to raise the chin to obtain the effect of cervical traction.
[0007] In order to overcome the limitations such as fallacies of cost, fragility, design and operational complexities, and validity parameters, there is a need to provide an instrument that is robust, easy to use, and simple and is likely to measure cervical motions in all three planes with good validity.
OBJECTS OF THE INVENTION
[0008] The principal object of the present invention is to overcome the disadvantages of the prior art by providing an instrument (or apparatus) that allows cervical neck movement estimation in all three dimensions ie, lateral flexion, lateral rotation, and sagittal flexion and extension.
[0009] Another object of the present invention is to provide an instrument that is

robust and tough, suitable for field and outdoor patients, and economical.
[0010] Another object of the present invention is to provide an apparatus that determines the neck movement accurately.
[0011] Yet another object of the present invention is to provide an instrument that can be used by any health worker without any specialized training.
[0012] Yet another object of the present invention is to provide an instrument that requires limited contact with the subject and can be cleaned easily.
[0013] The foregoing and other objects of the present invention will become readily apparent upon further review of the following detailed description of the preferred embodiment as illustrated in the accompanying drawings.
SUMMARY OF THE INVENTION
[0014] According to a first aspect of the present invention, there is provided a Cervical Rotational Movement Instrument (CRI) for determination of movements of a neck region of a user, the instrument comprising a dome-shaped frame adapted to receive a head portion of the user, wherein the dome-shaped frame includes, a first curved member parallel to a sagittal plane, a second curved member parallel to a coronal plane and normal to the first curved member, and a third curved member parallel to a transverse plane and normal to the first and the second curved members, a fabric strap with an optical pointer, the fabric strap being adapted to be wrapped around a face, a pre-auricular area, a temple, and a vertex of the user, wherein the optical pointer is adapted to be located at the vertex, and another fabric strap with another optical pointer, the other fabric strap being adapted to be wrapped around a lower jaw of the user, wherein the other laser pointer is adapted to be located at a chin area on the lower jaw.
[0015] In one embodiment of the invention, the instrument comprises a vertical column adapted to attach and support the dome-shaped frame.
[0016] In one embodiment of the invention, the dome-shaped frame is attached with the vertical column, at the first curved member, through a curved extension

parallel to the sagittal plane.
[0017] In one embodiment of the invention, the vertical column is telescopic in construction including a plurality of longitudinal members adapted to slide with respect to each other for height adjustment of the vertical column.
[0018] In one embodiment of the invention, the instrument comprises a shoulder stabilizing sub-assembly adapted to support the shoulders of the user, wherein the shoulder stabilizing sub-assembly includes an adjustment mechanism for modification of height and/or width of the shoulder stabilizing sub-assembly.
[0019] In one embodiment of the invention, the shoulder stabilizing sub-assembly includes two shoulder stabilizing pads, one for each shoulder, each one of the two shoulder stabilizing pads including a cushion member.
[0020] In one embodiment of the invention, the adjustment mechanism includes a first sleeve member slidably attached to the vertical column for height adjustment of the shoulder stabilizing sub-assembly, and two L-shaped members adapted to slide within the first sleeve member for width adjustment of the shoulder stabilizing sub-assembly. Each one of the two L-shaped members includes a first arm and a second arm normal to the first arm, such that, the two first arms are adapted to be inserted into the first sleeve member, and the two second arms are attached with the two respective shoulder stabilizing pads.
[0021] In one embodiment of the invention, the two L-shaped members are attached with the two respective shoulder stabilizing pads through two additional sleeve members, such that, the two second arms are adapted to slide within the two respective additional sleeve members for depth adjustment of the shoulder stabilizing sub-assembly.
[0022] In one embodiment of the invention, the vertical column is attached to a stand including a plurality of legs adapted to support the instrument on a given platform.
[0023] In one embodiment of the invention, the plurality of legs includes fastening arrangements adapted to fasten the instrument with the given platform.

[0024] While the invention has been described and shown with particular reference to the preferred embodiment, it will be apparent that variations might be possible that would fall within the scope of the present invention.

BRIEF DESCRIPTION OF DRAWINGS
[0025] So that the manner in which the above-recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may have been referred by embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.
[0026] These and other features, benefits, and advantages of the present invention will become apparent by reference to the following text figure, with like reference numbers referring to like structures across the views, wherein:
[0027] Fig. 1A illustrates a user with several planes of references;
[0028] Fig. 1B illustrates several types of neck movements known in the field of the present invention;
[0029] Fig. 2A illustrates a Cervical Rotational Movement Instrument (CRI) for determination of movements of a neck region of the user, in accordance with an embodiment of the present invention;
[0030] Fig. 2B illustrates a perspective view of a fabric strap of the CRI, in accordance with an embodiment of the present invention;
[0031] Fig. 2C illustrates a front view of the fabric strap of Fig. 2B;
[0032] Fig. 3 illustrates an implementation of the CRI during operation, in accordance with an embodiment of the present invention;
[0033] Figs 4A and 4B illustrate determination of sagittal extension and flexion, respectively, using the CRI, in accordance with an embodiment of the present invention;
[0034] Figs 5A and 5B illustrate determination of lateral flexion, using the CRI, in accordance with an embodiment of the present invention; and
[0035] Figs 6A and 6B illustrate determination of lateral rotation, using the CRI, in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0036] While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
[0037] As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
[0038] In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
[0039] The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
[0040] The present invention relates to an instrument that allows cervical neck movement determinations in all three dimensions ie, lateral flexion, lateral rotation, and sagittal flexion and extension. In that regard, the determinations of displacement in either directions are facilitated through optical pointers that may emit diffused electromagnetic radiation such as visible light or may emit monochromatic light through the deployment of lasers. The instrument is further envisaged to be adjustable to accommodate varying body shapes and sizes. Referring to the drawings, the invention will now be described in more detail.
[0041] Fig. 1A illustrates a user 102 in a standing position, with several planes of references. The planes of references include a sagittal plane 110 that is normal to front and back sides of the body of the user 102, a coronal (front) plane 120 parallel to the front and back sides of the user, and normal to the sagittal plane 110. Fig. 1A also illustrates a transverse plane 130 that is envisaged to be parallel to the level ground where the user 102 is supposed to be standing, in a manner that the transverse plane 130 is envisaged to divide the body of the user 102 into an upper portion and a lower portion.
[0042] Fig. 1B illustrates several types of neck movements known in the field of the present invention. In that manner, Fig. 1B illustrates sagittal extension where the neck of the user 102 is extended backward, sagittal flexion where the neck is bent forwards, lateral rotation where the neck is rotated sideways, and lateral flexion where the neck is flexed sideways. The morbidities in these movements, if present, may be identified, with the help of the instrument of the present invention, as would be described in the following discussion.
[0043] Fig. 2A illustrates a Cervical Rotational Movement Instrument (CRI200) (hereinafter referred to as “the instrument 200”) for the determination of movements of the neck region of the user 102, in accordance with an embodiment of the present invention. As illustrated in Fig. 2A, the instrument 200 includes a dome-shaped frame 205 adapted to receive a head portion of the user 102. The dome-shaped frame 205 includes a first curved member 210 parallel to the sagittal plane 110. Further, the dome-shaped frame 205 includes a second curved member 220 parallel to the coronal plane 120. Moreover, the second curved member 220 is normal to the first curved member 210. The dome-shaped frame 205 also includes a third curved member 230 parallel to the transverse plane 130 and normal to both the first curved member 210 and the second curved member 220, thereby forming the 3-Dimensional structure of the dome-shaped frame 205.
[0044] The material of the dome-shaped frame 205 may be plastic, metallic, or any other composite material, etc. For facilitating the determination of the angular displacements, the first curved member 210 has been provided with graduated markings 0 to 90 degree, 0 being at the lower end, the second curved member 220 has been provided with graduated markings of 0 at the top and 90 degrees on both sides and the third curved member 230 has been provided with graduated markings of 0 to 90 degree, 0 being at the center and 90 on two opposing edges.
[0045] The instrument 200 further includes a vertical column 240 adapted to attach and support the dome-shaped frame 205. In that manner, as depicted in Fig. 2A, the dome-shaped frame 205 is attached with the vertical column 240, at the first curved member 210, through a curved extension 244 parallel to the sagittal plane 110. Further, the vertical column 240 is telescopic in construction including a plurality of longitudinal members 242 adapted to slide with respect to each other for height adjustment of the vertical column 240. In several embodiments, the vertical column 240 may be made up of steel, for example, cold-rolled steel, while certain components for attachment of other constituents of the instrument 200 may be made up of plastic or composite materials. However, the invention is not limited to any specific arrangement or scheme of materials used.
[0046] The instrument 200 also includes a shoulder stabilizing sub-assembly 250 adapted to support the shoulders of the user 102. The shoulder stabilizing sub-assembly 250 includes an adjustment mechanism for modification of height and/or width of the shoulder stabilizing sub-assembly 250. The shoulder stabilizing sub-assembly 250 includes two shoulder stabilizing pads 252, one for each shoulder. Also, each one of the two shoulder stabilizing pads 252 includes a cushion member for the comfort of the user 102 during the operation of the instrument 200. In several embodiments, the shoulder stabilizing sub-assembly 250 has been provided parallel to the transverse plane 130.
[0047] There are several constructions of the adjustment mechanism possible, however, in one embodiment of the invention, the adjustment mechanism includes a first sleeve member slidably attached to the vertical column 240 for height adjustment of the shoulder stabilizing sub-assembly 250, and two L-shaped members adapted to slide within the first sleeve member for width adjustment of the shoulder stabilizing sub-assembly 250. Moreover, each one of the two L-shaped members includes a first arm and a second arm. The second arm is normal to the first arm forming the “L” shape. The two first arms are adapted to be inserted into the first sleeve member, and the two second arms are attached with the two respective shoulder stabilizing pads 252. In several embodiments of the invention, the two L-shaped members may be attached with the two respective shoulder stabilizing pads 252 through two additional sleeve members arranged normally to the first sleeve member. In that regard, the two second arms may be adapted to slide within the two respective additional sleeve members for depth adjustment of the shoulder stabilizing sub-assembly 250.
[0048] Fig. 2A further illustrates that the vertical column 240 has been attached to a stand 260 including a plurality of legs 262 adapted to support the instrument 200 on a given platform. In several embodiments of the invention, the plurality of legs 262 may be provided with fastening arrangements adapted to fasten the instrument with the given platform. The fastening arrangements may include holes for insertion of bolts, or welded bolts, or arrangement for magnetic fastening, etc.
[0049] Fig. 2B illustrates a perspective view of a fabric strap 270 with an optical pointer 272 of the instrument 200, in accordance with an embodiment of the present invention. The optical pointer 272 may emit diffused electromagnetic radiation such as visible light or may emit monochromatic light through the deployment of lasers. Fig. 2C illustrates a front view of the fabric strap 270 of Fig. 2B. As illustrated in Fig. 2C, the fabric strap 270 includes the optical pointer 272, a conductive plate 274, preferably made up of aluminum or copper, for installation of the optical pointer 272, and a power source 276 such as a rechargeable battery for providing electrical power to the optical pointer 272. The fabric strap 270 of Fig. 2C also includes a loops region 273 and a hooks region 275, together forming loops and hooks fastening arrangement. However, a person skilled in the art would appreciate that the invention is not limited to the loops and hooks fastening arrangements alone, and several other fastening arrangements may be incorporated without departing from the scope of the invention. Such fastening arrangements may include, but are not limited to, snap-fit arrangements, pin and hole arrangements, friction hold arrangements and magnetic arrangements, etc.
[0050] The fabric strap 270 is adapted to be wrapped around the face of user 102 via an angle of the jawline of the user 102, a pre-auricular area, a temple, and a vertex of the user 102, in a manner that the optical pointer 272 is adapted to be located at the vertex. The instrument 200 is envisaged to include another fabric strap 270 with another optical pointer 272. The other fabric strap 270 is adapted to be wrapped around a lower jaw of the user 102, wherein the other laser pointer 272 is adapted to be located at a chin area on the lower jaw.
[0051] Fig. 3 illustrates an implementation of the instrument 200 during operation, in accordance with an embodiment of the present invention. During the operation of the instrument 200, the user 102 inserts their head into the dome-shaped frame 205. Further, the shoulder stabilizing sub-assembly 250 is adjusted to locate the two shoulder stabilizing pads 252 on the two shoulders of the user 102, respectively, thereby preventing shoulder movements while the user attempts the neck movements. Further, the user 102 wears one fabric strap 270 around the lateral side of the face, having the optical pointer 272 at the vertex which corresponds to the 0-degree mark of the second curved member 220 in a neutral position. Further, the user 102 wears the other fabric strap 270 around the chin having the other optical pointer 272 at the center of the chin, which corresponds to the 0-degree mark on the third curved member 230.
[0052] Furthermore, the user 102 stands on the platform keeping their back straight and the dome-shaped frame 205 is lowered to fit symmetrically around the head. Fitting is then checked using the two optical pointers 272. In that manner, the two shoulder stabilizing pads 252 are placed around shoulders and a spirit level, on shoulder stabilizing sub-assembly 250, is referred to for ensuring horizontal non-tilted positioning. Consequently, the user 102 is asked to make neck movements in three planes keeping the shoulder stable.
[0053] Figs 4A and 4B illustrate determination of sagittal extension and flexion, respectively, using the instrument 200, in accordance with an embodiment of the present invention. In the given embodiment, the sagittal flexion and extension are measured. The angular movement of extension ?1 is checked by the optical pointer 272 located at the chin as illustrated in Fig. 4A. The angular movement of flexion is calculated by checking the total angular displacement of the optical pointer 272 at the vertex on the first curved member 210 (90 degrees minus the indicated angle ?2), as illustrated in Fig. 4B.
[0054] Figs 5A and 5B illustrate determination of lateral flexion, using the instrument 200, in accordance with an embodiment of the present invention. In the embodiment illustrated in Figs 5A and 5B, the lateral flexion is determined by instructing the user 102 to tilt their neck to the right side of an observer (Fig. 5A) and/or left side (Fig. 5B) of the observer, fixing their shoulders, and keeping the optical pointer 272 at the chin center at 0 degrees of the third curved member 230. Angular movement on the lateral flexion is calculated by the optical pointer 272 at the vertex pointing on the second curved member 220. As illustrated in Fig. 5A, the angle a1 indicates the lateral flexion towards the right side. Similarly, in Fig. 5B, the angle a2 indicates the lateral flexion towards the left side.
[0055] Figs 6A and 6B illustrate determination of lateral rotation, using the instrument 200, in accordance with an embodiment of the present invention. The lateral rotation movement is determined by instructing the user 102 to rotate their head in a horizontal plane keeping the shoulders stable. For this, the optical pointer 272 at the vertex is fixed at 0 degrees on the second curved member 220. Angular movement of lateral rotation is calculated by the optical pointer 272 at the chin center position on the third curved member 230. Fig. 6A illustrates and angular movement of ß1 towards the right side of the observer and Fig. 6B illustrates an angular movement of ß2 towards the left side of the observer.
[0056] The present invention as described above offers several advantages. The instrument as described above is robust and tough and is therefore suitable for field and outdoor patients. The instrument can be used without any training by any health worker. The instrument has no delicate parts, thus wear and tear is less likely. The instrument is simple in design and construction, and therefore, can be produced at nominal cost. During operation, contact with the user is limited to straps only, which can be easily cleaned. The instrument can make measurements in three axes, i.e., lateral rotation, lateral flexion, and sagittal flexion/extension. Also, the use of optical pointers to mark the angular movement ensures relatively high accuracy of measurements.
[0057] Various modifications to these embodiments are apparent to those skilled in the art from the description and the accompanying drawings. The principles associated with the various embodiments described herein may be applied to other embodiments. Therefore, the description is not intended to be limited to the 5 embodiments shown along with the accompanying drawings but is to be providing the broadest scope consistent with the principles and the novel and inventive features disclosed or suggested herein. Accordingly, the invention is anticipated to hold on to all other such alternatives, modifications, and variations that fall within the scope of the present invention and appended claims.

CLAIMS:
We Claim:
1. A Cervical Rotational Movement Instrument (CRI) (200) for determination of movements of a neck region of a user, the instrument (200) comprising:
a dome-shaped frame (205) adapted to receive a head portion of the user, wherein the dome-shaped frame (205) includes:
a first curved member (210) parallel to a sagittal plane (110),
a second curved member (220) parallel to a coronal plane (120) and normal to the first curved member (210), and
a third curved member (230) parallel to a transverse plane (130) and normal to the first (210) and the second (220) curved members;
a fabric strap (270) with an optical pointer (272), the fabric strap (270) being adapted to be wrapped around a face, a pre-auricular area, a temple, and a vertex of the user, wherein the optical pointer (272) is adapted to be located at the vertex; and
another fabric strap (270) with another optical pointer (272), the other fabric strap (270) being adapted to be wrapped around a lower jaw of the user, wherein the other laser pointer is adapted to be located at a chin area on the lower jaw.
2. The instrument (200) as claimed in claim 1, comprising a vertical column (240) adapted to attach and support the dome-shaped frame (205).
3. The instrument (200) as claimed in claim 2, wherein the dome-shaped frame (205) is attached with the vertical column (240), at the first curved member (210), through a curved extension parallel (244) to the sagittal plane (110).
4. The instrument (200) as claimed in claim 2, wherein the vertical column (240) is telescopic in construction including a plurality of longitudinal members (242) adapted to slide with respect to each other for height adjustment of the vertical column (240).
5. The instrument (200) as claimed in claim 2, comprising a shoulder stabilizing sub-assembly (250) adapted to support the shoulders of the user, wherein the shoulder stabilizing sub-assembly (250) includes an adjustment mechanism for modification of height and/or width of the shoulder stabilizing sub-assembly.
6. The instrument (200) as claimed in claim 5, wherein the shoulder stabilizing sub-assembly (250) includes two shoulder stabilizing pads (252), one for each shoulder, each one of the two shoulder stabilizing pads (252) including a cushion member.
7. The instrument (200) as claimed in claim 6, wherein the adjustment mechanism includes:
a first sleeve member slidably attached to the vertical column (240) for height adjustment of the shoulder stabilizing sub-assembly (250); and
two L-shaped members adapted to slide within the first sleeve member for width adjustment of the shoulder stabilizing sub-assembly (250);
wherein each one of the two L-shaped members includes a first arm and a second arm normal to the first arm, such that, the two first arms are adapted to be inserted into the first sleeve member, and the two second arms are attached with the two respective shoulder stabilizing pads (252).
8. The instrument (200) as claimed in claim 7, wherein the two L-shaped members are attached with the two respective shoulder stabilizing pads (252) through two additional sleeve members, such that, the two second arms are adapted to slide within the two respective additional sleeve members for depth adjustment of the shoulder stabilizing sub-assembly (250).
9. The instrument (200) as claimed in claim 2, wherein the vertical column (240) is attached to a stand (260) including a plurality of legs (262) adapted to support the instrument (200) on a given platform.
10. The instrument (200) as claimed in claim 9, wherein the plurality of legs (262) includes fastening arrangements adapted to fasten the instrument (200) with the given platform.