WO2020060490A1

WO2020060490A1 - Improved brace and method of manufacture

Info

Publication number: WO2020060490A1
Application number: PCT/SG2019/050471
Authority: WO
Inventors: Jarrick SEE
Original assignee: See Jarrick
Priority date: 2018-09-19
Filing date: 2019-09-19
Publication date: 2020-03-26

Abstract

A brace arranged to apply corrective force to a thoracic and/or lumbar region of a patient, the brace shaped to include: at least two active pressure zones in vertical spaced relation; wherein an upper active pressure zone of said at least two active pressure zones is arranged to apply an upwardly directed vertical force component and the lower active pressure zone is arranged to apply a downwardly directed vertical force component to said thoracic and/or lumbar region.

Description

IMPROVED BRACE AND METHOD OF MANUFACTURE

Field of Invention

This invention relates to the field of biomedical engineering and in particular, the field of orthotics. Specifically, this invention relates to an improved brace, and its method of manufacture. One example of use includes the treatment of various forms of scoliosis.

Background

Scoliosis is defined as the presence of a lateral curve to the spine (one or more) which is greater than 10 degrees with vertebral rotation. Scoliosis is usually encountered in the primary care setting and affects around 2% - 4% of adolescents. Scoliosis is generally regarded as a 3D deformity of the trunk and spine that progresses quickly during periods of rapid growth. Although females and males have approximately the same minor scoliosis of 10 degrees, the incidence, progression, and severity of scoliosis in females is more than five to ten times than that of males.

Scoliosis screening has been conducted in Singapore schools since 1982. The screening is usually performed using visual inspection of the back, Forward Bending Test (FBT), and angle of trunk rotation (ATR) measurement using a scoliometer. It has been found a substantial number of female students (aged between 9-13 years) were diagnosed with scoliosis. It has also been found that there was a 50% increase in the number of female students affected by scoliosis (aged 9-10 years) who received active intervention. The number of adolescent and adult scoliosis cases in Singapore is projected to increase. Treatment of patients with spinal deformities could be facilitated through physiotherapy, brace treatment, and surgery. Brace treatment is the most widely used scoliosis treatment modality, especially in children and adolescents, though it has also been used in managing adult scoliosis. Bracing has been found to significantly reduced the risk of curve progression and the need for surgery. The outcome of using braces to correct the spinal curvature depends on the correlation between in-brace correction and compliance. Asymmetric braces are preferred over symmetric braces owing to their increased corrective effect.

Summary of Invention

In a first aspect, the invention provides a brace arranged to apply corrective force to a thoracic and/or lumbar region of a patient, the brace shaped to include: at least two active pressure zones in vertical spaced relation; wherein an upper active pressure zone of said at least two active pressure zones is arranged to apply an upwardly directed vertical force component and the lower active pressure zone is arranged to apply a downwardly directed vertical force component to said thoracic and/or lumbar region.

In a second aspect, the invention provides a method of manufacturing a brace arranged to apply a corrective force to a thoracic and/or lumbar region of a patient, the method

comprising the steps of: surveying a shape of a spine of the patient; determining corrective force vectors required for treatment; creating an active pressure zone on a hip area of the brace to generate a corrective force vector; creating an active pressure zone on a pelvic region, and so; balancing and de-rotating hip imbalance; creating active pressure zones having force vectors on a convexity side of respective curves along a torso of the patient; creating a passive reaction zone at an axilia region of the brace; providing connective area in the form of passive reaction zones intermediate the active pressure zones.

The invention relates to a brace used for the treatment of various forms of scoliosis.

Specifically, the brace is arranged to apply a a plurality of force vectors (magnitude plus direction) at pre-determined locations, leading to the application of a resultant tensioning load along a critical length of the patient’s spine, being the net resultant force of applied vertical components of loads applied. The applied loads, which may be distributed loads, may have both horizontal and vertical force components, and are arranged to be applied through active pressure zones, being shaped portions of the brace, said shape being a function of any one or a combination of: the patient’s body, the form of scoliosis suffered by the patient, the corrective force required, the angle of resultant load for that active pressure zone.

The application of force is such that an upper load has an upwardly directed vertical component and a lower load has a downwardly directed vertical component, with the resultant of the vertical component representing the tensioning force applied to the patient. In one embodiment, the brace may be arranged such that the two loads may act on the same side of the brace. In an alternative arrangement, the brace may be arranged such that the two loads may act on opposed sides of the brace.

In addition to the above mentioned loads, the brace is arranged to apply a third load. The third load may have a purely horizontal component with no vertical component. Alternatively, the third load may also have a vertical component. In a further embodiment, one or more active pressure zones may be arranged to include a forward force component, either separately or in combination with a horizontal and/or vertical component. The forward component is intended to be represented as a z-axis direction, notionally horizontal but directed along an axis from the patient’ s back to front. In this case, the horizontal component referred to is generally considered to be along an x-axis defined by the axis from one side of the patient to the other. The vertical component is therefore defined as a y-axis component.

The invention is distinguished from the prior art whereby prior art braces apply essentially horizontally directed point loads having purely horizontal components, at specific locations in order to achieve the corrective result, a. It will be appreciated that the point load of the prior art may be applied through a padded area for the comfort of the patient. This does not represent a distributed load as compared to that of the present invention whereby the substantial portion of the brace acts to apply the uniform load as compared to discreet padded portions of the prior art brace.

In at least an embodiment, a pressure pad may be provided on lumbar medial side in order to create an elongation and extension effect on the spine. In at least an embodiment, gaps may be provided in the brace at places which are on opposite side of pressure zones so that it prevents compression on to the wearer’s side from both sides. Also, overall weight of the brace is reduced. The brace may be moulded to high precision based upon detailed metrics from a patient. The brace also be 3D printed. The patient’s torso may be scanned electronically, which would aid in the 3D printing after converting from the scanned file. Brief Description of Drawings

It will be convenient to further describe the present invention with respect to the accompanying drawings that illustrate possible arrangements of the invention. Other arrangements of the invention are possible and consequently, the particularity of the accompanying drawings is not to be understood as superseding the generality of the preceding description of the invention.

Figure 1 is an elevation view of a brace according to the prior art; Figure 2A is a schematic view of a torso having a deformed spine prior to treatment;

Figure 2B is a trunk having a realigned spine following treatment by brace according to the present invention; Figures 3A to 3D are schematic representations and corresponding photographs pf patients having various forms of scoliosis;

Figure 4 is a schematic view of a brace arranged to treat a 3C thoracic curve pattern according to one embodiment of the present invention; Figures 5A and 5B are photographs of a patient having a 3C thoracic curve pattern before and after use of the brace of Figure 4;

Figure 6 is a schematic view of a brace arranged to treat a 4C double curve pattern with pelvic rotation according to one embodiment of the present invention;

Figures 7 A and 7B are photographs of a patient having a 4C double curvature pattern with pelvic rotation before and after use of the brace of Figure 6; Figure 8 is a schematic view of a brace arranged to treat an N3N4 double curvature pattern without pelvic rotation according to one embodiment of the present invention;

Figure 9A and 9B are photographs of a patient having an N3N4 double curvature pattern without pelvic rotation before and after use of the brace of Figure 8;

Figure 10 is a schematic view of a brace arranged to treat a lumbar/thoracolumbar curvature pattern according to one embodiment of the present invention;

Figures 11A and 11B are photographs of a patient having a lumbar/thoracolumbar curvature both before and after use of the brace of Figure 10;

Figures 12A to 12C are isometric views of a brace according to one embodiment of the present invention, and; Figures 13A to 13C are isometric views of a brace according to a further embodiment of the present invention.

Detailed Description

The brace according to the present invention seeks to solve the problems of the prior art which are substantially directed to applying horizontal force to the thoracic and lumbar regions based upon a geometrically simplistic consideration of the required treatment for various forms of scoliosis.

Various embodiments of the present invention provide greater efficacy by developing a holistic approach to treatment that is based upon a 3 -dimensional consideration of spinal deformation. Various embodiments provide alternative arrangements of the brace compared to that of the prior art which may include any one or a combination of:

(i) The application of a tensioning force: The brace is arranged to apply a resultant force, through a plurality of active pressure zones, to the thoracic and/or lumbar regions. The active pressure zones may apply a combination of horizontal and vertical components. The vertical components include upwardly and downwardly directed forces and thus applying a tensioning force to the spine;

(ii) The active pressure zones apply the force as a distributed load: The application of force being applied is a true distributed load and thus may cover a greater length of the spine in applying the force. This compares to prior art braces that apply force through the insertion of pads with the brace itself merely being a sleeve arranged to hold the pads in place. A brace according to the present invention may be moulded and patient specific so as to have the shape of the brace applying the load rather than merely acting through a placed pad;

(iii) The active pressure zones may also apply forces directed in a forward direction, along a z-axis: Prior art braces which only apply x-axis horizontal loads, that is from side to side, are effectively single dimension devices based upon a simplistic geometry. A brace according to the present invention, because it applies a distributed force having both a vertical and horizontal component, is therefore 2-dimensional. In the current embodiment the brace may also apply a force along an axis from the patient’s back to the patient’s front. Thus, in this embodiment a true 3-dimensional application of force and consequently treatment may be achieved;

(iv) The application of force further seeks to provide a lateral shift to the convex side of a thoracic curve;

(v) The brace may be formed such that separate and distinct regions are arranged as force application regions (active pressure zones) with corresponding regions on the opposed side of the brace being arranged as reaction regions (passive reaction zones) providing a passive force resistance as a reaction against the aforementioned force regions. It will be noted that the reaction zones, whilst not applying an active force, are sufficiently sized so as to act as a reaction and thus fit closely to the patient. It is noted further that braces of the prior art include regions adjacent to force application portions, however, they are invariably loose fitting intentionally so as to provide comfort for the patient. A brace according to the current embodiment of the present invention is based on the principle that this is an incorrect treatment and that to apply a holistic treatment to the patient the brace must be fitted so that all regions along the side of the brace at least are either actively applying force or passively reacting against applied force;

In order to facilitate any or all of the above features, in a further embodiment of the present invention, a brace may be custom designed based upon a geometric survey of the patient and 3-D printed so as to customize the design of the brace to identify the required location of the active and passive zones. This recognizes that the specific deformation pattern experienced by a patient having scoliosis may be somewhat different and therefore the placement of the active and passive zones may vary substantially from patient to patient.

Figure 1 shows a brace 5 according to the prior art for dealing with various curvatures 30, 35 of the spine 27. applying corrective forces (5, 10) to a torso. The series of horizontally directed point loads, as is provided by the prior art essentially concentrates the corrective force at specific locations. This tends to take a simplistic assessment of the patient’s requirements, primarily because of the limitations of currently available braces. By recognising that the problem exists in 3 dimensions, it is clear a 3 dimension application of distributed force is also required.

It will be noted that prior art braces, whilst applying a corrective force at specific locations, may appear to apply a distributed load, as the brace is bound to the patient. It will be appreciated, however, that the force applied by the brace intermediate the padded point loads provides no useful corrective benefit; the intermediate distributed load is too small for the required corrective force. In fact, this intermediate distributed load may be kept relatively low for the comfort of the patient. This is distinct from a passive reaction zone of the present invention, which provides a balancing reactive pressure against the active pressure zones.

Furthermore, prior art braces have the wearer appear to have a hyper arm-lift from either side, depending on curve structure. This arm-lift is intentional so as to relieve the wearer’s spine off the compression force.

For the present invention, the distributed load may be applied by customizing the shape of the brace to fit the patient to ensuring a high tolerance fit for the transmission of said distributed load. To this end, a brace according to the present invention may be customised to fit the patient to ensure the distributed corrective force is applied.

The brace 5 includes pads arranged to apply the horizontal loads 10, 15, 20 at various locations corresponding to the curvatures 30, 35.

As mentioned, the application of load by the prior art brace is intentionally horizontal along an x-axis. Also, at an opposed side of the brace to that of the application of force are voids in the brace 23, 29. This demonstrates that a prior art brace intentionally omits reaction zones, which would provide a passive application of force. Instead the voids 23, 29 are arranged for comfort for the patient at the expense of the efficacy of the treatment, with the application of force being resisted by frictional engagement of the brace to the patient, with the consequential problems of offset forces this generates.

Figures 2A and 2B show an intended result from use of the brace 40 whereby curvatures 45, 57 of the spine 60 are subjected to a lateral shift towards the convex side of the spine so as to straighten 60 or lessen the curvature 65 so as to move from the situation in Figure 2A to the post treatment arrangement shown in Figure 2B.

Figures 3A to 3D show characteristic curvature patterns most commonly found in scoliosis patients. Figure 3A shows a patient 70 having 3C thoracic curve pattern. Figure 3B shows a patient 75 having a 4C double curvature pattern including a pelvic rotation in the lumbar region. Figure 3C shows a patient 80 also suffering a double curvature pattern without the pelvic rotation. The N4 pattern in this case has a relatively straight portion of the spine in the lumbar area with an N3 double curvature pattern having curvature in the lumbar region but without the characteristic pelvic rotation of the 4C condition. Figure 3D shows a patient 85 whereby the curvature pattern is located purely in the lumbar or thoracolumbar region. As will be shown later, the curvature of Figure 3D may only require a smaller brace in the lumbar region but still demonstrating one or more of the features which combine into an embodiment falling within the present invention.

Figures 4 and 5B show an embodiment of a brace falling within the present invention directed to correcting a 3C thoracic curve pattern as shown in Figure 5A. As discussed, the brace 90 is arranged to provide a lateral shift 135 of the trunk and applied at the convex side of the thoracic curve. In this case, the brace 90 applies a plurality of force vectors (magnitude plus direction) at three active pressure zones 95, 110, 125. Two of the pressure zones 95, 110 are on one side and separated by a reaction zone 105. The other pressure zone 125 located on the opposed side of the brace at an upper portion of the side having a reaction zone 127 beneath the active pressure zone 125. The active pressure zone 125 applies a force 120 distributed over an extended area so as to manifest as a distributed load. The force 120 has a resultant force direction with both a vertical and horizontal component with the vertical component directed upwards.

The upper active pressure zone 110 applies a horizontal force 115 with the lower active pressure zone 95 having a resultant force 100 with a horizontal and vertical component with the vertical component being directed downwards. Consequently, the horizontal components of the active and passive zones balance with the vertical components directed upwards and downwards also balancing and applying a tensioning force along the spine.

It will be further noted in this embodiment that the active pressure zone 125 further includes a forward force to accommodate the thoracic de-rotation both for applying the shifting force as well as to correct and balance any offsetting component applied by any of the active pressure zones. It will be noted that the prior art brace creates such offsetting forces through a lack of reaction zones, but is not equipped to correct such detrimental forces. It will be appreciated that the thoracic and lumbar regions are not symmetrical and therefore there may be a consequential application of force in the forward direction along the z-axis that may need correction hence the application of a forward force 140.

Figures 6 and 7B show a brace according to a further embodiment of the present invention so as to treat a 4C double curve pattern with a pelvic rotation. Again the brace 155 is directed to apply a lateral shift to the convex side of a thoracic curve towards the concave side. There are three active pressure zones 170, 185, 200 at which the force vectors are applied, with a first side having an active pressure zone 70 applying a horizontal force 165. On either side of the active pressure zone 170 are passive reaction zones 160, 175. The two active pressure zones 185, 200 on the opposed side of the brace 155 both apply force vectors 190, 205 having both horizontal and vertical components. The vertical components are in opposed direction such that the brace 155 applies a tensioning force to the spine. The active pressure zones 185, 200 are separated by a passive reaction zone 195. It is further noted that both the active pressure zones 185, 200 apply a forward force for de-rotation of both the thoracic and pelvic regions 215, 220. In particular, the 3-dimensional force component applied by the active pressure zones 200, 210 having both vertical, horizontal and forward directional components are particularly efficacious for treating the pelvic rotation as characterized in the 4C curvature pattern.

Figures 8 and 9B show a brace 240 arranged for an N3N4 double curvature pattern without pelvic rotation. The features of the brace 240 of Figure 8 are similar to that shown in Figure 6 with one side of the brace having an active pressure zone 295 applying horizontal force 250 with passive reaction zones 245, 290 on either side. This is balanced by the active pressure zones 255, 280 having resultant forces 265, 285 and separated by a passive reaction zone 270. An active pressure zone 260 adjacent to the upper pressure zone 255 allows for a forward force component of the force vector, so as to apply a de-rotational force to the thoracic region. It is further noted that the lower active pressure zone 280 does not require a similar forward force as was required for the brace of Figure 6 because of the lack of pelvic rotation. The resultant forces 265, 285 further have opposing vertical components so as to apply a tensioning force to the spine with the overall resultant force seeking to apply a lateral shift to the convex side of the thoracic curve. Figures 10 and 11B show a partial brace directed to treating a lumbar/thoracolumbar curve pattern whereby the thoracic spine portion is relatively straight and curvature of the spine occurring in the lumbar region. Accordingly, whilst there is a smaller active pressure zone 370 applying horizontal force 365 adjacent to the top of the brace 310, the primary active pressure zones 325, 350 are on opposed sides adjacent to the lumbar region and having the opposed vertical components so as to still apply a tensioning force to the spine, however the tensioning force is a applied lower on or adjacent to the lumbar region. Significantly, the lower active pressure zone 350 includes an active pressure zone 335 for the application of the forward force 340. It is further noted that the brace include an extended reaction area with reaction zones 355 and 360 separating the upper smaller active zone 370 from the lower active zone 350. Including with braces falling within the present invention the lateral shift is applied to the convex side of the lumbar curve and thus is generally directed away from the smaller side of the partial brace.

Figure 12A shows a brace comprising a first contoured portion, characterised in that, a first contour, of the brace, defines a hip embracing contour 67 wherein a first locus of points define a first degree of bulged curvature 62 of the anterior portion of the hip embracing contour, this first degree of curvature being directed downwards and towards a right hand side lateral axis of the wearer of this brace (i.e. from the anterior median plane towards the anterior coronal plane) and a second locus of points define a second degree of bulged curvature 64 of the posterior portion of the hip embracing contour 67, this second degree of curvature being directed downwards towards the same right hand side lateral axis of the wearer of this brace (i.e. from the posterior median plane towards the posterior coronal plane). This hip embracing contour tightly engages with the hip of a wearer so as to act / enforce a reaction point for application of the distributed corrective force to the spine. This hip embracing portion may engage the hip; both above and below. In prior art braces, the brace ended above the hip of the wearer so reaction forces were not fully directed towards the spine corresponding to that level.

Figure 12B shows a brace comprising a second contoured portion, characterised in that, a second contour, of the brace, defines a side torso embracing contour 77 wherein a third locus of points define a third degree of bulged curvature 72 of the medial portion of the side torso embracing contour, this third degree of curvature being directed upwards and towards a shoulder of the wearer of this brace (i.e. from the posterior coronal plane to the medial plane) and a fourth locus of points define a fourth degree of depressed curvature 74 of the medial portion of the side torso embracing contour, this fourth degree of curvature being directed downwards and towards a thigh of wearer of this brace (i.e. from the anterior coronal plane to the medial plane).

Figure 13 A shows a brace comprising a third contoured portion, characterised in that, a third contour, of the brace, defines a back embracing contour 87 wherein a fourth locus of points 86 - 86 define a S-shapes curvature (fourth curvature) which mirrors the deformed spine curvature of the wearer of the patient. In order to effect pressure on to this defined spine, the back embracing contour 87 is defined by a further fifth locus of points which define a fifth curvature angled towards the S-shaped curvature from an upper portion of the medial axis (i.e. from the right side posterior coronal plane to the median plane) and a further sixth locus of points which define a sixth curvature angles towards the S-shaped curvature from a lower portion of the medial axis (i.e. from the left side posterior coronal plane to the median plane). Figure 13B shows a brace comprising a fourth contoured portion, characterised in that, a fourth contour, of the brace, defines a split front embracing contour 97 wherein a seventh locus of points 92 define a seventh curvature angled towards the front medial axis of the wearer (i.e. from the right hand side coronal plane to the medial plane) and an eighth locus of points 94 define an eighth curvature angled towards the front medial axis of the wearer (i.e. from the left hand side coronal plane to the medial plane). The brace is split, on its front side, through the middle.

Prior art braces uses only a 3-point bending principle to apply forces. However, the current brace of the invention uses the Cartesian co-ordinate system for forces to be applied from all side to respective curves’ regions (i.e. from a curve’s apex to about 2 vertebrates down). In at least an embodiment of this invention, force applied to the spine is at a 45 degree angle from medial side to lateral side (transverse plane) of the body of the wearer of this brace. Thus, there is helical force that is applied at pre-defined curvilinear portions of the brace.

The method steps followed are as follows:

1. Assessed and determined curve pattern via BSPTS system and visual/clinical

observation and x-rays.

2. Create pressure pad on the hip area, which is the reaction/engaging point for the

distributed corrective forces.

3. Create force pad at the pelvic region to address and de-rotate hip imbalance.

4. Create "XYZ axis" force pads on the convexity side of the respective curves along the torso.

5. Create support pad at the axilia (underarm) region. 6. Add / build volume on the opposing sides of the forces and support pads, front of the torso, front of the pelvic - anterior superior iliac spine (ASIS) . This enables the migrating of the body and spine into a corrected posture.

These steps enable to have a corrected mould of the body and posture. In one embodiment, following such a process may result in a brace formed as a single shell, providing the required corrective force vectors through the molding of the shell. This is distinct from the prior art, which provides a generic shape, and provides the corrective force vectos through applying padding. The prior art brace is therefore nothing more than a means of holding the padding in place, with mounting of the brace providing the magnitude of force, rather than the shape of the attached device.

Further, the brace according to the present invention may having an anterior opening to the shell, whereby the wearer is able to fit the brace themselves without assistance. Prior art braces require the opening, and subsequent engagement, to be from the back. This requires the wearer to be assisted in fitting the brace, limiting the ability of the wearer to function independently. The inclusion of an anterior opening for the present embodiment enhances independent living. The opening may then be selectively engaged and disengaged to fit to the wearer. The opening may include any one of a range of engagement methods, including buckles, Velcro™ and straps.

The technical advancement of this invention lies in providing a brace which acts to provide tensioning force along the curve of the spine which may be achieved by an application of a uniform distributed load for a significant length of the spine, thereby providing a semi- continuous force, when compared with discrete point forces of prior art braces. Additionally, the brace, of this invention, allows a wearer to have a better shoulder balance while maintaining in-brace correction. The brace, of this invention, may also exclude an intentional arm- lift, since this brace is able to relieve the spine off compression forces through migration of the body and spine via the brace.

Claims

1. A brace arranged to apply corrective force to a thoracic and/or lumbar region of a patient, the brace shaped to include: at least two active pressure zones in vertical spaced relation; wherein an upper active pressure zone of said at least two active pressure zones is arranged to apply an upwardly directed vertical force component and the lower active pressure zone is arranged to apply a downwardly directed vertical force component to said thoracic and/or lumbar region.

2. The brace according to claim 1, wherein the upper active pressure zone is located adjacent a top of said brace, and the lower active pressure zone is located adjacent a bottom of said brace;

3. The brace according to claim 1 or 2, wherein the upwardly and downwardly directed vertical force components are arranged to apply a tensioning force to a spine of said patient.

4. The brace according to any one of claims 1 to 3, the brace further includes at least one passive reaction zone.

5. The brace according to any one of claims 1 to 4, further including at least one active pressure zone arranged to apply a forward force component to said thoracic and/or lumbar region.

6. The brace according to any one of claims 1 to 5, wherein a force vector applied at at least one active pressure zone is applied to the spine at an angle from a medial side to a lateral side, such that a helical force is applied at pre-defined curvilinear portions of the brace.

7. A method of manufacturing a brace arranged to apply a corrective force to a thoracic and/or lumbar region of a patient, the method comprising the steps of: surveying a shape of a spine of the patient; determining corrective force vectors required for treatment; creating an active pressure zone on a hip area of the brace to generate a corrective force vector; creating an active pressure zone on a pelvic region, and so; balancing and de -rotating hip imbalance; creating active pressure zones having force vectors on a convexity side of respective curves along a torso of the patient; creating a passive reaction zone at an axilia region of the brace; providing connective area in the form of passive reaction zones intermediate the active pressure zones.

8. The method according to claim 7, further including the step of forming an opening on the anterior of the brace, said opening arranged to selectively engage and disengage for fitting said brace to the patient.