AU2021105113A4 - Modular Spine Orthotic System - Google Patents

Abstract

: The Modular Spine Orthotic System uses an interchangeable collection of purposely designed Spine Orthotics, which are secured upon purpose made positioning apparatus, referred to as Positioning Systems. The purpose of the invention is to facilitate a customised therapeutic intervention for human spine related pain and dysfunction, through an intentional and accurate alignment influence of the entire length of the spine and the associated spinal soft tissues. The unique construction and design of the interchangeable collection of spine orthotics facilitates a customisable solution to match the unique anatomy and therapeutic requirements of each user. The Positioning Systems are designed to both secure the Spine Orthotics and to position the user in a variably recumbent, supine position where the Spine Orthotics assert influence upon the spinal tissues againstthe opposing force of gravity. The Modular Spine Orthotic System does not use the application of force (mechanical or energy) to influence the spinal alignment once the user is positioned correctly upon the system. The Positioning Systems include (i) 2 methods of mechanically reclining the user from an upright seated position to a variably recumbent, supine position, and (ii) a non-mechanical, Floor Based Positioning System. Various singular, independent spine orthotics which can be used without a positioning system. The Modular Spine Orthotic System is intended to be applicable for home or office use in addition to use in the clinical setting. It is intended that the Modular Spine Orthotic System be used in conjunction with an appropriate exercise strategy and educational material to optimise the therapeutic benefit.

Description

Invention Title: Modular Spine Orthotic System

Technical Field: Healthcare Equipment -Therapeutic intervention for human spine related pain; non-surgical, non-invasive, non-pharmaceutical, non-ingestible.

Background and purpose of the invention:

[0001] Spine related pain commonly involves tissues of the spine being in varying states of functional imbalance including; spinal joint restriction, soft tissue pathology, and nervous system pathology. The application of non-surgical, manual treatment by a trained clinician (e.g. Physiotherapist, Osteopath or Chiropractor) upon the human spine inherently carries a degree of riskof further damage or injury to the patient. The absence of high velocity force, end range spinal joint mobilisation or impact force or pressure to the spinal tissues during a therapeutic intervention can significantly reduce the risk of adverse effects or further injury.

[0002] Intentional and accurate positional alterations of the spinal tissues into a position of optimally reduced tissue tension (tissue or anatomical neutral), when in static rest, can provide symptomatic relief and affect a positive therapeutic intervention in the spinal tissues. This is achieved through facilitating improved functional biomechanics, assisting interstitial fluid transfer and improving homeostatic processes and within the tissues. Achieving such results manually has been common practice in manual medicine practice for many years.

[0003] The Modular Spine Orthotic System is designed to accurately influence the alignment and quality of an individual's spinal tissues whilst they are in static rest in a supine, recumbent position. The Modular Spine Orthotic System does not apply force or mechanical spinal repositioning whilst the user is optimally positioned upon the apparatus. Potential patient outcomes from correct application of the Modular Spine Orthotic System include; (1) accurately improving specific spinal joint mobility, (2) improved spinal alignment and function through positional influence of the entire spine, (3) reducing soft tissue strain and spasm at specific spinal locations through inhibition (a technique of applying direct pressure to a muscular trigger point) or reducing tissue tension through positioning, and (4) relieving spinal regions of inflammatory fluid accumulation through improved interstitial tissue fluid transfer.

[0004] Significant biometric and functional variance of the spinal tissues occurs between most individuals. Significant biometric and functional variance can occur within the spinal tissues of a single individual during the course of a therapeutic intervention or at different times of their lives depending on physical demands and health status. The Modular Spine Orthotic System facilitates customisation according to the spinal tissue variances of both biometric and functional differences between individuals. Furthermore, it facilitates a dynamic therapeutic process to accommodate the changes in the biometric and functional changes in the spinal tissues of a single individual during the course of a therapeutic intervention.

Summary of invention:

[0005] The Modular Spine Orthotic System uses an interchangeable collection of purposely contoured and variable size and density cushions and supports (hereafter called 'spine orthotics'), which are secured upon purpose made positioning apparatus (referred to as 'positioning systems'). The purpose of the invention is to facilitate symptomatic relief and therapeutic intervention for human spine related pain and dysfunction, through an intentional and accurate alignment influence of the entire length of the spine and the associated spinal soft tissues. Modular Spine Orthotic System is intended for use in a clinical setting by a therapist providing therapeutic intervention or for home and office use where used independently by the user.

[0006] The interchangeable collection of spine orthotics facilitates a customisable solution to match the unique anatomy of each user. The intended combination of spine orthotics are fixed to the positioning system and the user is positioned upon the positioning system in a recumbent, supine position. The influence of the Modular Spine Orthotic System upon the user's spinal tissues is achieved via the opposing force of gravity as the user's weight bares down on the spine orthotics once the user is positioned correctly upon the pre-arranged spine orthotics.

[0007] The positioning systems are designed to both secure the spine orthotics and hold the user upon the spine orthotics to optimally assert influence upon the spinal tissues. The positioning systems include; (i) 2 methods of mechanically reclining the user from an upright seated position to a variably recumbent, supine position, and (ii) a non-mechanical, floor based positioning system. Various singular, independent spine orthotics which can be used without a positioning system.

[0008] The intellectual property of The Modular Spine Orthotic System involves; (i) The spine orthotics, including the modular assembly system of the spine orthotics used to create a customisable therapeutic intervention and the shapes and construction of the spine orthotics, (ii) The Positioning Systems designed for attachment or support of the interchangeable Spine Orthotics and, importantly, to place the user in the optimal position for therapeutic influence and (iii) the shapes and geometry of singularspine orthotics to be used without a positioning system.

Description:

SPINE ORTHOTICS

[0009] The spine orthotics are purposefully designed for each region of the spine including the pelvis, lumbar spine, thoracic spine and cervical spine to provide an accurate therapeutic influence for the full length of the human spine. Integral to the design of the Modular Spine Orthotic System is the ability to add or remove individual spine orthotics, or all of the spine orthotics, easilyfrom the positioning system.

[0010] The interchangeable system of variable size, contour and density spine orthotics facilitates user customisation, necessarydue to the significant anatomical variance of the spinal tissues between individuals. Furthermore, it allows customisation for the purpose of providing a patient specific therapeutic intervention that can be altered according to changing anatomical or symptomatic presentations throughout the course of a therapeutic intervention.

[0011] Accurate biometric data can be obtained from an individual user or collective biometric data can be gained from a large sample group to determine the most suitable spine orthotic arrangement for the desired therapeutic influence. The biometric data is obtained via numerous methods including; 3D body scanning, body pressure mapping, digital measuring and posture assessment tools and radiological assessment (x-ray, MRI, Computed tomography).

[0012] The range of spine orthotics comprising the Modular Spine Orthotic System vary in construction material, length, width, thickness, density, contour and attachment system;

[0013] The construction materials facilitate the anatomical accuracy and therapeutic influence of each spine orthotic in addition to adaption to the positioning system used to assemble and apply the modular spine orthotic components. Details of the construction materials and methods used for the spine orthotics are as follows;

(A) A spine orthotic constructed of silicone, accurately shaped using a mold: Biometric data is used to design the spine orthotic's shape on CAD/CAM software. The CAD/CAM design is then transferred to a CNC router which machines the desired shape mold into a solid block of extruded polystyrene, or similar material. Liquid silicone is poured into the mold to form the spine orthotic to the desired shape.

An intentionally and variably contoured upper surface is created depending on the desired therapeutic influence upon the user's spine. This construction method can be used to create a spine orthotic for use on a positioning system, a singularspine orthotic for use without a positioning system, or as an insert placed on spine orthotics constructed of other materials.

A silicon spine orthotic may be used without a cover or additional material overlays. Alternatively, a natural latex layer or open/closed cell foam layer may overlay the silicone upper surface and then covered.

(B) A wood or foam base layer, shaped with an intentionally and variably contoured upper surface, covered with a natural latex rubber or foam overlay which is then covered with an appropriate surface material for usercontact. The wood or foam base layer is accurately shaped with a CNC router to create a desired therapeutic influence. This method may be used to create singularspine orthotics as part of a modular group or as a larger, singularspine orthotic that encompasses the entire length of a user's spine or specific sections of a user's spine to be used upon a positioning system.

(C) Spine orthotics constructed of a plywood base layer, an extruded polystyrene core layerwith an intentionally and variably contoured upper surface, and a natural latex rubber or open/closed cell foam overlay forming the upper surface: The plywood (Balsa plyor similar) base layer is used to assistwith attachment to a positioning system, via magnets or fixtures on the underside surface, and attachment of the core layer on its upper surface.

A stepped recess ('female part') is cut into the upper surface of the plywood base layer for inserting the core layerwhich has a corresponding rebate ('male part') machined into it's under surface for accurate fitting to the base layer.

The extruded polystyrene (or similar high density foam) core layer facilitates accurately shaped upper surface contours and apertures which are designed using CAD design software. The surface contours and apertures vary depending upon the desired influence on the spinal tissues. A CNC router is used to shape the contours and apertures with high accuracy and repeatability. A sealing agent, such as 'Rosco Foam Coat', is used to coat the shaped core layer to improve hardness and facilitate a better contact surface for foam attachment on the upper surface.

Combinations of open and closed cell foams of varying density and thickness are fixed upon the machined contours and apertures of the upper surface of the machined core layer. The use of varying combinations of foam densities on the upper surface of the core layer facilitates further customisation of the influence and feel of the spine orthotic upon the user's spine.

Each orthotic is covered in medical grade PU material (or similar medical grade materials) such as 'Carrflex Bi-Flex' or'Carrflex Extreme' and may be sewn or seam welded using an ultrasonic seam welder (or similar) for effective hygiene.

This construction method may be used to form a single structure to encompass the entire length of the spine or a combination of individual sections that form the length of the spine when placed together on a positioning system.

(D) Spine orthotics are constructed entirely of open or closed cell foam, without the use of a high density foam core layeror plywood base layer. Therapeutic influence upon the user's spinal tissues can be achieved via either; (i) patterns or apertures machined into the foam material to accurately create a desired effect upon the spinal tissues, or(ii) layers of varying foams to create a specific influence upon the user's spinal tissues.

Each orthotic is covered in medical grade PU material (or similar medical grade materials) such as 'Carrflex Bi-Flex' or'Carrflex Extreme' and may be sewn or seam welded using an ultrasonic seam welder (or similar) for effective hygiene.

This construction method may be used to form a single structure to encompass the entire length of the spine or a combination of individual sections that form the length of the spine

(E) 3D printed, silicon moulded or machined inserts: intended to be accurately placed within apertures upon existing spine orthotics. These used to create anatomically highly accurate influences upon the user's anatomy or to amend or improve existing spine orthtotics.

(F) Thermal influence Spine orthotics: These spine orthotics can be placed in specific locations upon a positioning system for a desired therapeutic influence. Filled with Lupin seeds (or similar materials with high thermal retention) and covered with natural material, these spine orthotics can be heated or cooled prior to placement upon a position system. The materials (covers and contents) of these thermal influence Spine Orthotics can be altered to modify their therapeutic influence. For example, firmer spine orthotics with a more rigid cover may be used in some spinal regions where less dense cushions with elastic covers may be used in other regions simultaneously to create a spinal alignment influence in conjunction with interchanging thermal qualities (hot or cold) to further change the therapeutic influence.

(G) 3D printed structures: May be used to form the upper layer in part, or a Spine Orthotic in its entirety. It is an intended feature of the Modular Spine Orthotic System to provide orthotic designs that can be reproduced by a 3D printer at any location. 3D printed spine orthotics may be used to create a single spine orthotic, or a combination of parts custom made to fit an individuals' entire spine from coccyx to upper cervical spine and occiput. 3D printing materials include elastic polymers such as 'DuraForm TPU'.

[0014] The length of each spine orthotic may vary significantly to allowfor a diversity of intended therapeutic interventions. A singular Spine Orthotic, encompassing the entire length of the spine, or a combination of individual sections can comprise the system in its entirety.

[0015] The width of each spine orthotic may vary significantly to allow for a diversity of therapeutic interventions.

[0016] Thethickness of each spine orthotic may vary significantly depending on the combinations of construction materials used to allow for customisation of an individual's anatomy and the requirements of each spinal region.

[0017] The density of each spine orthotic may vary significantly depending on the combinations of construction materials used and the placement of patterns and apertures cut into the material to facilitate a diversity of therapeutic interventions. In particular, the use of open and closed cell foams or natural latex rubber will vary greatly in density and properties when different foam combinations are used to form a spine orthotic in part or its entirety.

[0018] The construction and design method of the contoured surfaces of the spine orthotics are an integral part of the intellectual property of this patent and are subject to continued development for the purpose of gaining improved accuracy for therapeutic intervention. It is intended that more ecologically sustainable materials will be used the construct the spine orthotics in a similarfashion as these materials become more accessible and cost effective.

[0019] Each spine orthotic is labelled with a QR code to direct the userfor the details and intended purpose of the orthotic.

POSITIONING SYSTEMS:

[0020] The positioning systems for the Modular Spine Orthotic System consistof 3 purposefully designed apparatus: (1) A ReclinerChair, (2) A Retracting/Reclining platform system calledthe Bed Based System (BBS) and (3) a Floor Based System (FBS). The positioning systems are designed for attachment and support of the interchangeable spine orthotics and, importantly, to place the user in the optimal position for therapeutic influence. The positioning systems and their unique design are an integral part of the intellectual property of this patent. The description for these apparatus is as follows:

[0021] (1). The Recliner Chair (hereafter referred to as 'Chair'): A purposefully designed recliner chair that is intended by design to facilitate attachment of the Modular Spine Orthotic System and positioning of the user for optimal therapeutic influence upon the spine and related tissues. The Chair is designed to facilitate mounting and dismounting by the user upon the spine orthotic system from the upright seated position, similarto the positioning of a regular chair. From the mounting position the Chair reclines to a position where the backrest is horizontal to the floor, or 5-10 degrees past this position if desired by the user or interventional therapist, whilst the user is seated on the Chair.

[0022] Intentional therapeutic influence is first initiated when the user is in the upright seated position via an interchangeable orthotic attachment system on the seat part of the chair. The initial pelvic and spinal positional influence achieved by the Chair in the upright seated position is integral to the intended purpose of the Modular Spine Orthotic System. This design feature facilitates intentional alterations of positioning of each pelvic innominate bone, the sacrum, the hip joints and their associated soft tissue structures. The sacroiliac joints, pubis symphysis and the lumbar spine and their associated soft tissue structures are intentionally influenced in the vertical, flexion/extension, rotational and side bending planes of movement. A removable section to eliminate any pressure upon the coccyx, if the user experiences coccydynia, is also included in this design.

[0023] The initial influence of the Spine Orthotic System in the upright seated position initiates optimised spinal tissue tension ease and biomechanical alignment influence for the entire spine, from the pelvis and sacrum to the top of the cervical spine and the occiput of the cranium. This design feature is the first stage of an intended 3 dimensional alignment influence upon the user's pelvis.

[0024] It is in the reclined position that the intended influence of the spine orthotics upon the user's spine is most effective. Reclining 5-10 degrees past the backrest's horizontal position is an intentional feature that facilitates the inclusion of some gravitational force in the cephalad direction to traction the user's spinal tissues whilst in the reclined position. The Chair is purposefully engineered to withstand the forces of achieving this range of movement under load. The design of the Chair is integral to the intellectual property of this patent.

[0025] The Chair is constructed of steel, or similarstrength material, for the purpose of; (1) Withstanding the mechanical forces involved in the required range of movement, (2) to allow attachment of the Spine Orthotic System via magnets, straps, Velcro or reciprocating male/female surface apertures or contours, and (3) allow for later attachment of additional technology for therapeutic intervention.

[0026] The reclining/return to upright action is powered by a linear actuator such as the 'Linak LA 31' or 'LA 40' or similar product. Future construction of the Chair using 3D printing materials &/or carbon fibre materials is intended.

[0027] As the chair reclines to the backrest horizontal position, the Sacral spine orthotic of the Modular Spine Orthotic System is used to intentionally influence the position of the sacrum and each innominate bone independently to influence rotational and side bending components of the sacral position between each innominate bone of the pelvis. This positioning intentionally influences the multifactorial biomechanical components of the sacroiliac articulations and their subsequent influence upon the alignment of the spine and it's tissues.

[0028] Alignment of the pelvic tissues into a position of biomechanical and optimal tissue ease is further gained by maintaining the hip flexion position of userwhilst seated in the Chair. The Chair intentionally maintains an increased hip flexion position rather than reducing the hip flexion angle such as in the positioning of a person laying in a reclining comfort chair or adjustable comfort bed.

[0029] The ability to further influence the lumbo-pelvic tissues by influencing distal lower limb positioning is an intentional component of the Chairdesign. For example, raising the distal lower limb on one side will reduce rectus femoris muscle tension on the anterior innominate bone of the same side and subsequently reduce its anterior rotation influence on that side of the pelvis.

[0030] Subsequent spine orthotic arrangements upon the backrest section of the chair influence the alignment of the lower lumbar spine facetjoints and the associated soft tissues. Intentionally increasing flexion through the lower lumbar spine facet joints 'opens' the related intervertebral foramen creating more space for the neural structures exiting these foramina. This has the intended therapeutic benefit of facilitating physiological change in the surrounding tissues through improved fluid transfer and reduced nociceptive output. Reduced load on the intervertebral discs at the lower lumbar spine level and alteration of the lumbar spine and innominate bone alignment is also achieved intentionally.

[0031] Further spine orthotic additions to the Modular Spine Orthotic System are added to the backrest (Thoracic and Cervical) section of the chair prior to the chair reclining and are held in place via magnets, Velcro, straps or male/female reciprocating surface features or apertures. As the Chair reclines each Spine orthotic, as chosen and positioned by either the user or the Interventional Therapist, will influence the alignment of the users' spine in all planes of movement according to the desired effect in accordance with the user's unique anatomy and symptomatic presentation.

[0032] When the Chair is reclined to 90 degrees the spine orthotics positioned upon the backrest (thoracic and cervical) section will assert optimal influence on the spine as gravity exerts opposing force to the spine orthotics surface contours, thicknesses and densities. Beyond 90 degrees of recline of the chair a subtle traction force on the spine can be applied safely as the user's centre of gravity drifts more in a cephalad direct.

[0033] Two future additions to the rear of the back (thoracic and cervical) section include; (1) extracorporeal shockwave (electromagnetic shockwave) technology that is capable of emitting therapeutically beneficial doses of electromagnetic shockwave energy in accurate locations. It is intended this will have the capacityto be controlled remotely by an interventional therapist or operated by the user via pre-set therapeutic programs and, (2) a sound system comprising of subwoofer, coaxial and tweeter speakers of specific placement that project sound vibration force in a safe fashion towards the user's spine and spinal tissues. These additions are third party manufactured and not part of the intellectual property of this patent.

[0034] Third party manufactured massage vibration motors, or pneumatic massage systems, can be custom positioned over the orthotic system via a neoprene (or similar material) cover or attached under the covering of the orthotic. Customised positioning, based on biometric data and the intended therapeutic influence, are part of the intellectual property claims of the Modular Spine Orthotic System. The vibration motor and pneumatic massage system technologies are not part of the intellectual property claims of the Modular Spine Orthotic System.

[0035] Virtual Reality (VR) googles or screen imagery will also be used to deliver educational content and/or create additional sensory influence for the purpose of increasing the therapeutic benefit. An extruded aluminium structure encompassing the Chairto position a screen and place speakers for optimal effect, when the Chair is reclined, is also included in the design.

[0036] This concludes the description of the Chair.

[0037] (2). The Bed Based System (BBS): A purposefully designed reclining/retracting platform system that facilitates similar patient positioning and Modular Spine Orthotic System functionality as the Chair. Made from extruded aluminium to facilitate customised geometry for individual users, the BBS consists of three independently moving platforms powered by linear actuators which facilitate a greater range of patients positions compared to the Chair.

[0038] The Bed Based System is mounted by the user from the front in the seated position from which point the user is reclined to varying supine recumbent positions upon the pre set spine orthotics. This facilitates comfortable user mounting/dismounting and multiple positioning options, in varying positions of recumbency, for application of the Modular Spine Orthotic System.

[0039] The thoracic platform raises and lowers on an angle from the centrally located hinge and holds the sacral, lumbar, thoracic and cervical components of the Modular Spine Orthotic System. The seat platform functions independently from the thoracic platform. It raises and lowers at its front edge where it is mounted by the user, the rear edge is fixed to hinges at the central hinge brace for both the seat and thoracic platforms. The lower leg platform is attached to the seat platform via hinges at its rear edge and functions independently via a linear actuator mounted under the seat platform and attaching to the under surface of the lower lag platform.

[0040] The independent function of each platform allows for a high degree of user position arrangement of optimum comfort and ease of use. 3-Dimensional pelvic realignment, as with the function of the Modular Spine Orthotic System on the Chair, is also achieved and intentionally applied on the Bed Based System.

[0041] The Bed Based System is intended for both use in a clinical setting by a therapist providing therapeutic intervention or for home and office use where used independently by the user. A high degree of customisation for individual users is an intentional design feature of the Bed Based System, allowing for a high degree of accommodation to individual user anatomy in addition to the versatility of the Modular Spine Orthotic System attached to it. The Bed Based System for use in a clinical setting has the addition of a column lift actuator underneath it to facilitate regular height changes for ease of use.

[0042] This concludes the description of the Bed Based System.

[0043] (3). Floor-based Positioning System (FBS): This system consists of a Box Bolster, referred to as the 'FBS box', which facilitates user positioning in the supine recumbent position, and a mat which is placed upon the floor and secures the arrangement of the Modular Spine Orthotic System in place. The Floor Based Positioning System is designed to be a lightweight and space efficient method for using the Modular Spine Orthotic System. No powered mechanical components are used to position the user or adjust the FBS box or spine orthotic positions.

[0044] The FBS Box functions as a support to hold the user's lower limbs in the recumbent position for optimal influence of the Modular Spine Orthotic System. Design variations of the FBS box facilitate the FBS box functioning as a storage system for the contents of the Floor Based System when not in use.

[0045] The FBS box has three construction designs depending on required stability and storage/transportation requirements. These construction methods include; (i) a flat-pack design for lightweight versatility and ease of storage, (ii) an extruded aluminium frame with plywood (or similar) panels and rear or top access panels forstorage access, and (iii) a welded steel design for optimal strength and stability. FBS designs (ii) and (iii) include the functionality to store the components of the floor based system within the FBS box. The functionality to store the contents of the FBS within the FBS box is a key intellectual property feature.

[0046] The user positions themselves upon the arranged spine orthotics, positioned upon the mat, and places their lower limbs upon the FBS box. The FBS box is custom fitted to the user's biometrics and their ideal recumbent position for optimal influence of the spine orthotics. The Modular Spine Orthotic System used in conjunction with the FBS box is also customised to the user's needs as per the Chairand Bed Based System.

[0047] This concludes the description of the Modular Spine Orthotic System.

Appendix A: Primary Images and Artwork

Explanatory note on the presentation of artwork; 'Appendix A' contains the primary images and photos pertaining to the intellectual property of the Modular Spine Orthotic System.

'Appendix B' contains additional, assistive images of the designs and earlier versions of the primary designs. These are also considered to be inclusive in the Modular Spine Orthotic System intellectual property.

The images of the Positioning Systems are presented first. The images of the Spine Orthotics are presented following this. Due to the customisable nature of the invention, many images, particularly of the Spine Orthotic designs, will be added post filing as the designs progress.

Some artwork image delays have been experienced due to the COVID-19 pandemic. Improved artwork of the current images will be submitted post-filing. It is understood by the patentee that only submitted images filed can be claimed as protected intellectual property.

Labelling methodology;

The label for each image is above the image. Each image has been labelled with a code to assist with the review process.

The initial letters of each label represent the item or device and the number attached to the letters is the version of the device. The following numbers represent the sequential numbering order of the images. For example: CH = Chair CH1= Chairversion 1 CH1001- Chairversion 1, Image 1

BBS= Bed Based System BBS1= Bed Based System version 1 BBS1 001= Bed Based System version 1, Image 1

FBS = Floor Based System FBS1= Floor Based System version 1 FBS1001= Floor based system version, image 1

SO 00001=Spine Orthotic Number 00001

Inventory of attached images with itemised code and explanation:

(1). CH4 001 - Photo of Chairversion 4 prototype. Front view with chair in upright position. Modular spine orthotic system not attached.

(2). CH4 002 - Photo of Chairversion 4 prototype. Rearview with chair in upright position. Modular spine orthotic system not attached.

(3). CH4 003 - Photo of Chairversion 4 prototype. Front view with chair in reclined position. Modular spine orthotic system not attached.

(4). CH4 004 - Photo of Chairversion 4 prototype. Rearview with chair in reclined position. Modular spine orthotic system not attached.

(5). CH4 005 - Chair version 4 CAD drawing. Reclining with man image. Modular spine orthotic system not attached.

(6). CH4 006 - Chair version 4. Reclined with man image. Modular spine orthotic system not attached.

(7). CH4 007 - Chair version 4. Upright position pivot image. Modular spine orthotic system not attached.

(8). CH4 008 - Chair version 4. Design screenshot of actuator positioning (reclining mechanism) and stress analysis

(9). CH4 009 - Chair version 4. Rear actuator mount design

(10). CH 010 - Chair version 4. Design kinematics image

(11). CH4 011 - Chair version 4. Basic dimensions

Pivot Height 650mm Base Width 750mm Seat Width 700mm Thoracic Height 1200mm Seat Depth 500mm Lower Leg Length 600mm

(12). CH4 012 - Modular assembly example of spine orthotics on seat and backrest sections for attachment to Chairand BBS

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(13). CH4 013 - Image of Chairversion 4 complete with attachment of spine orthotic system attachment

Artwork Pending

(14). BBS2 001 - CAD images of Bed Based System Version 2 without actuators

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(15). BBS2 002 - BBS2 functionality concept Image

(16). BBS2 003 - Images of assembled Bed Based System Version 2 with function range and Spine Orthotic system attached and demonstration of positional ranges

Artwork pending

(17). BBS2 004 - Image of Bed Based System Version 2 mounted on column lift actuator

Artwork pending

(19). FBS1 001 - Floor Based System Version 1; Box steeiframe with skin on. FBS mat attaches to hooks shown in 'Detail B'

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(22). FBS1 008 - Floor Based System Version 1. Canvas mat and example of Spine Orthotic positioning and size approximation (Not actual Spine Orthotics). FBS Box not included in image

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(23). FBS2 001 - Floor based System Version 2; Extruded aluminium frame CAD drawing (Castors not shown)

(24). FBS2 002 - Floor based System Version 2; Extruded aluminium frame dimensions example

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(25). FBS3 001- Illustration of Floor Based System Version 3. Flat pack design with adjustable lower leg support and spine orthotic assembly on FBS mat

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(26.) FBS3 002 - Images of completed Floor Based System assembly

Artwork Pending

(27). SO 0001- Spine orthotic machined XPS and plywood construction example

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(28). SO 0002 - Spine Orthotic example of machined XPS foam surface with variable density foam assembly

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(29). SO 0003 - Foam samples used to achieve a broad range of therapeutic effects and customisation of spine orthotics

(30). SO 0004- Spine Orthotic modular assembly examples for seat sections of Chair and BBS

(31). SO 0005 - Modular assembly example of spine orthotics on seat and backrest sections for Chairand BBS

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(32). SO 0005 - Silicon Spine Orthotic including mould used to shape it

Artwork Pending

(33). SO 0006 - Images of Silicon and 3D printed Spine Orthotic inserts

Artwork Pending

(34). SO 0007 - Evolving inventory of Spine Orthotic shapes, dimensions and constructions

Ongoing inclusions

(35). SO 0008 - Images and geometry of singular Spine Orthotics to be used without a Positioning System

Artwork Pending

(36). SO 0009 - Images of Spine Orthotics used for Thermal Influence

Artwork Pending

(37). SO 0010 - Images of Spine Orthotics with imbedded patterns and apertures for specific therapeutic influence

Artwork Pending

Appendix B: Secondary Images and artwork

(01). CH4 014 - Chair version 4 Initial concept drawing 01

(02). CH4 015 - Chair version 4 Initial concept drawing 02

(03).CH4016- Chairversion4.Cradlestressanalysisimage

(04). CH4 017 - Chair version 4. Pivot stress analysis image

(05). CH3 001- Chair version 3. Rotational design Images

(06). CH2 001- Chair version 2 design

(07). CH1001-Chairversion 1 design

(08). CH1002 -Chair version 1 Photo

(09). CH1003- Chair version 1 reclining photo

(10). BBS1001- Bed Based System Version 1; CAD drawing without actuators

(11). BBS1002 - Bed Based System Version 1; lowered thoracic platform image without actuator

(12). BBS1003 - Bed Based System Version 1; raised thoracic platform image without actuator

(13). BBS1004 - Bed Based System Version 1; retracted rear platform image without actuator

(14). BBS1005 - Bed Based System Version 1; rear upright platform image without actuator

(14). BBS1006 - Bed Based System version 1; centre mount without actuators

(15). FBS1 009 - Floor Based System Version 1; Box skin front CAD Image

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Shellharbour City Osteopathic Clinic A Floor Based System

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(16). FBS1 010 -Floor Based System Version 1;Box skin rear CADimage

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(17). FBS1 011- Floor Based System Version 1; Box skin Floor

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(19). FBS1013 - FBS V1Initial concept drawing of cushion cover dimensions

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(20). FBS2 003 - Floor Based System Version 2; concept drawing front view

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(21). FBS2 004 - Floor Based System Version 2; initial concept drawing side view

(22). Example of third party manufactured massage vibration motors and jig used to position vibration motors on spine orthotic system

The End.

Claims: Modular Spine Orthotic System

1. The Modular Spine Orthotic System is a modular, interchangeable system of spine orthotics that facilitates customisationto the unique anatomy and therapeutic requirements of individuals, for the purpose of achieving an accurate therapeutic influence of the entire length of the spinal tissues of the human spine . The ability to customise a fixed, sequential arrangement of Spine Orthotics and position the user in a variably recumbent, supine position upon the spine orthotics, for the purpose of asserting a therapeutic influence upon the entire length of an individuals spine, is unique to the Modular Spine Orthotic System.

2. The construction, contours and dimensions of each spine orthotic comprising claim 1 are unique to the Modular Spine Orthotic System.

3. The design of the Positioning Systems of claim1, including the reclining Chair based system, the Bed Based System (BBS) and the three Floor based positioning systems (FBS) are unique to the Modular Spine Orthotic System.