GB2576201A

GB2576201A - Orthotic device and orthotic methods

Info

Publication number: GB2576201A
Application number: GB1812974.2A
Authority: GB
Inventors: Alan Drew John
Original assignee: Prescription Footwear Ass Ltd
Current assignee: Prescription Footwear Ass Ltd
Priority date: 2018-08-09
Filing date: 2018-08-09
Publication date: 2020-02-12
Anticipated expiration: 2038-08-09
Also published as: GB2576201B; GB2577388B; GB201812974D0; GB2577388A; GB201911465D0

Abstract

The device comprises a first component (114, fig 12) which supports the foot of a user and a plantar component 180 having a bottom stock component and being locatable on and detachable from the first component. The plantar component may be formed as a plantar shell 182 with a plurality of bottom stock components 1841, 1842, 1843, 1844 in a stack formation. The stock components may have fastenings for detachably fastening them to the shell and/or another component. The stock components may comprise a rocker, wedge or raise. All the components may comprise 3D printed material. The device may comprise a second component (112, fig 12) to cooperate with the first component to support the foot or leg of the user.

Description

ORTHOTIC DEVICE AND ORTHOTIC METHODS

TECHNICAL FIELD

The invention relates to orthotic devices and to orthotic methods. In particular, the invention relates to a detachable component of an orthotic device, an orthotic device comprising the detachable component, and to corresponding methods.

BACKGROUND

An orthosis is a device that supports, corrects or contains a body part.

The demand for orthotic services for feet and legs is growing. One reason for this growth is an increasing occurrence of diabetes in developed countries. This increase, together with associated obesity and increases in neuropathy, has led to an increase in ulceration and infection problems of the feet and lower limbs. These cases become more complex with aging and the occurrence of other disease and physiological problems and if these problems are not managed effectively it is necessary to amputate limbs in order to save lives of patients.

As well as the significant negative effect that amputation of a limb has on the patient, the effect of high rates of amputation on health service resources is significant since, in addition to the cost of surgery, these patients require lifelong specialised nursing care and provision of prosthetics.

Effective treatment with orthoses can reduce the number of avoidable amputations and the associated requirement for theatre time, bed space and specialized nursing care. Better outcomes for individual patients are achieved, together with a reduction in overall health service costs.

However, the biomechanical need of the patient and/or the desired dimensions or cosmesis of the orthosis often change over time as a result of further surgical intervention or as a result of healing, as a patient transitions from an initial acute state to longer term requirements. The changing biomechanical need leads to changes in the biomechanical design of an orthosis required by the patient. In addition, orthoses become worn and need to be replaced.

The manufacture of current orthotic devices is labour intensive and requires a high level of skill as well as many hours to complete. It is difficult to provide effective orthotic treatment in a timely and cost-effective manner using the current techniques.

Accordingly, the present invention seeks to provide a novel orthotic device and orthotic methods that alleviate at least some of the disadvantages of the known orthotic devices and orthotic methods.

- 2 SUMMARY

Embodiments of the invention are defined by the accompanying claims.

The application discloses a new modular design for an orthotic device including a detachable plantar component, providing a bespoke orthotic device having an easily adjustable or replaceable bottom stock. In some embodiments, the plantar component comprises the bottom stock. In other embodiments, the bottom stock comprises a plurality of bottom stock components, and the plantar component is one of the detachable bottom stock components.

The bottom stock is a major factor in the biomechanical effect of the orthotic device. The biomechanical design of the bottom stock may be adapted to the clinical need of a patient by suitable design of the bottom stock or of bottom stock components, in particular selection of the size and/or shape and/or materials of the bottom stock or of bottom stock components, resulting in one or more of rockers, wedges (including left/right wedging to correct for pronation) and raises that give rise to a clinically effective biomechanical effect.

In accordance with one aspect of the disclosure, a plantar component comprising a bottom stock component can be detached or released and replaced in its entirety with a replacement plantar component comprising a bottom stock component. The biomechanical effect of the bottom stock is adjusted, and/or worn components replaced, while maintaining continuity of use of the orthotic device for the patient. Maintaining use of the orthotic device by the patient during adjustment of the biomechanical effect of the orthotic device and/or repair or replacement of worn components contributes significantly to improved patient outcomes.

Despite the modularity of the orthotic device, the components are firmly secured to each other so that the function of the orthotic device is not impaired. When assembled and during use, the plantar component is not able to move relative to the other components of the orthotic device. This ensures reliable provision of the desired biomechanical effect.

The detachable plantar component enables the orthotic device to be maintained or updated to meet the changing biomechanical needs of a patient in a much shorter time than current methods, which require that an orthotic device either has to be taken to a workshop for alteration, or a new device has to be made.

In some embodiments, a modular orthotic device is supplied with two plantar components. An initial plantar component is changed for a replacement plantar component once a significant wear pattern is established. The wear pattern is quickly

- 3 evaluated and, if needed, alterations made to the shape of the bottom stock to maintain or improve the biomechanics as needed. This can be done without the need for a second complete orthotic device, or the need for the original orthotic device to be taken away from the patient while changes are made.

In accordance with a second aspect of the disclosure, the plantar component is one of a plurality of bottom stock components that make up the bottom stock. The bottom stock components are held together using a releasable fastener and are detachable from a component adapted to support a patient limb, such as a posterior component of an orthotic device. The bottom stock components may be directly attached to a posterior component or may be indirectly attached to the posterior component by being supported or carried by a plantar shell. The detached bottom stock component can be modified or adjusted and then re-attached or removed entirely or replaced. This enables the biomechanical effect of the bottom stock to be adjusted, and/or enables worn components to be replaced, while maintaining continuity of use of the orthotic device for the patient. Maintaining use of the orthotic device by the patient during adjustment of the biomechanical effect of the orthotic device and/or repair or replacement of worn components contributes significantly to improved patient outcomes.

In some embodiments, the orthotic device can be adjusted or repaired in a single clinic visit, leading to a better patient experience and reduced cost. Even in situations where a return visit to clinic is required, the disclosed orthotic devices enable a patient to retain use of the orthotic device during the adjustment period, leading to better patient outcomes.

In addition, the useful life of a modular orthotic device can be extended by replacing and repairing different component parts of the orthotic device, leading to a reduction in the cost of the orthotic service.

In some embodiments, additive manufacturing technologies such as 3D printing can be used to reduce the cost of orthoses. The materials used to produce 3D printed devices may be cheaper per unit, and in some cases the material of discarded orthoses can be sterilised and recycled, leading to a decrease in the overall cost of the orthoses and a reduction in waste material. Additive manufacturing technologies may increase the speed of manufacture, leading to a faster turn-around.

Typically, the orthotic device is an orthosis having a shape that can be successively altered over time, as required, to provide desired biomechanical effects that more closely meet the changing clinical needs of patients.

BRIEF DESCRIPTION OF THE DRAWINGS

- 4 The invention will be described by way of example with reference to the accompanying drawings, in which:

Figure 1 is a side view of an anterior component of a modular orthosis in accordance with one embodiment of the disclosure.

Figure 2 is a cross-sectional view of the anterior component of Figure 1.

Figure 3 is a side view of a posterior component of a modular orthosis.

Figure 4 is a cross-sectional view of the posterior component of Figure 3.

Figure 5 is a side view of a bi-valve assembly.

Figure 6 is a cross-sectional view through line AA of Figure 5.

Figure 7 is a side view of a plantar component of a modular orthosis.

Figure 8 is a cross-sectional view of the plantar component of Figure 7.

Figure 9 is a partial cross-sectional view of the modular orthosis.

Figures 10a to 10e illustrate stages during assembly of the modular orthosis.

Figure 11 is a flow chart showing a method of assembly of a modular orthosis.

Figure 12 is a cross-sectional of the main components of a modular orthosis in accordance with a second embodiment of the disclosure, in a partially assembled state.

Figure 13 is a side view of the modular orthosis of Figure 12 in an assembled state.

Figure 14 is a cross-sectional view of an alternative plantar component, illustrating a third embodiment of the present disclosure.

Figure 15a is a plan view of a first bottom stock component shown in Figure 14.

Figure 15b is a plan view of a second bottom stock component shown in Figure 14.

Figure 15c is a plan view of a third bottom stock component shown in Figure 14.

Figure 15d is a plan view of a fourth bottom stock component shown in Figure 14.

Figure 16 is flow chart showing steps of a method of updating an orthotic device having a detachable component.

Figure 17 is a schematic diagram of the main elements of apparatus for manufacturing an orthosis.

Figure 18 is a flow chart of a method of manufacturing an orthosis.

DETAILED DESCRIPTION

Embodiments of the disclosure are described with reference to an orthosis for a patient’s leg and foot, as shown in the accompanying drawings. In the description, the same or similar elements are given the same or corresponding reference numerals to aid understanding.

- 5 As will be understood by a skilled person, the bottom stock of an orthosis, i.e. the heel and sole portion of the orthosis, supports a patient’s foot above the ground and can be rocker shaped adjacent the ground to improve walking efficiency. The shape, dimensions and materials of the bottom stock determine bottom stock parameters such as the supported height of the user foot above the ground and the point of heel strike together with the angle, degree and position of the rocker. In turn, the bottom stock parameters determine the biomechanical effect of the orthosis. As a result, a clinically desirable biomechanical advantage for an orthosis can be achieved by appropriate design of the bottom stock.

Orthosis 10 in accordance with a first embodiment is shown in Figures 1 to 9. Orthosis 10 is a modular orthosis typically comprising three main components: an anterior component, or anterior valve 12; a posterior component, or posterior valve 14; and a plantar component, or plantar valve 16. Straps 18 having a releasable fastener are provided to hold anterior valve 12, posterior valve 14 and plantar valve 16 together when assembled, as will be explained below. Seven straps 18 are shown in the disclosed embodiment, but a different number of straps are used in other embodiments, as required.

The anterior valve 12 is shaped to enclose and protect the upper foot and shin area of a user. Anterior valve 12 has an upper portion 22 corresponding with a user’s shin area and a lower portion 24 corresponding with a user’s upper foot and extending generally downwardly from the upper portion 22 at a clinically appropriate angle to the upper portion. The lower portion 24 terminates in an anterior valve toe portion 26 extending forward beyond a user’s toe area. The anterior valve 12 is provided with lugs 28 spaced along the front midline 30 of the upper portion 22 and lower portion 24.

The upper portion 22 and the lower portion 24 have a generally semi-circular or flattened semi-circular cross-sectional profile for covering and partially surrounding the front of a leg and the upper foot of a user. As shown in Figure 6, in the disclosed embodiment the thickness of the anterior valve 12 varies in a circumferential direction. In particular, a midline section 32 around midline 30 of the anterior valve 12 is relatively thick to provide strength and rigidity to the anterior valve 12 and to support lugs 28. Correspondingly, the medial and lateral edges 34 of anterior valve 12 are relatively thin, for example having a tapered profile. The tapered profile reduces weight and improves flexibility of the anterior valve 12 as well as the fitment with the posterior valve 14.

In the disclosed embodiment, the majority of the anterior valve 12 has a thickness of 0.002m (2mm) and midline section 32 has a thickness of 0.003m (3mm), although other thicknesses could be used depending on the materials used and clinical need, taking into account including any necessary safety margins.

- 6 The anterior valve 12 is made of any suitable material, including plastics materials such as polypropylene, and in the disclosed embodiment the anterior valve 12 is manufactured using a 3D manufacturing technique such as an additive manufacturing technique. Other clinically appropriate materials and manufacturing processes may be employed for the anterior valve 12 in different embodiments.

The posterior valve 14 is shaped to support and protect the calf and foot of the user. The posterior valve 14 has an upper portion 40 corresponding with the calf and ankle of a user, and a lower portion 42 corresponding with the foot and sole of a user, the upper portion 40 and lower portion 42 being separated by a heel portion 44. The lower portion 42 extends generally downwardly from the upper portion 40 at a clinically appropriate angle to the upper portion 40. The lower portion 42 terminates in a posterior valve toe portion 46 extending forward beyond a user’s toe functional area. Plantar portion 48 provides the bottom surface of lower portion 42.

Typically, the posterior valve 14 accommodates an insole (not shown) that fits snugly inside the posterior valve 14 and provides intimate contact, support and protection to the user’s foot. Sometimes, part of the foot of a user may be missing owing to accident or surgery, in which case the insole accommodates the remaining partial foot and dressing if needed. Typically, the orthosis 10 has a conventional external boot shape irrespective of the shape or completeness of the user’s foot.

The upper portion 40 has a generally semi-circular cross-sectional profile for partially surrounding the leg of the user. The posterior valve 14 is provided with lugs 52 in matching pairs on either side of the upper portion 40. As shown in Figure 6, in the disclosed embodiment the thickness of the posterior valve 14 varies in a circumferential direction such that medial and lateral edges 54 are relatively thin, for example having a tapered profile. The tapered profile reduces weight and improves flexibility of the posterior valve 14 as well as the fitment with the anterior valve 12.

In the disclosed embodiment, the majority of the posterior valve 14 in the circumferential direction has a thickness of 0.003m (3mm) while the lateral edges 54 have a thickness of 0.002m (2mm).

Posterior valve 14 is made of any suitable material, including plastics materials such as polypropylene, and in the disclosed embodiment posterior valve 14 is manufactured using a 3D manufacturing technique such as additive manufacturing. Other clinically appropriate materials and manufacturing processes may be employed for the posterior valve 14 in different embodiments.

As shown in Figures 3 to 5, the plantar portion 48 of posterior valve 14 is provided with a fastening 56 to fasten posterior valve 14 to plantar valve 16, as will be explained in

- 7 more detail below. In the disclosed embodiment, fastening 56 is located at a heel area of plantar portion 48 adjacent heel portion 44. The size and location of such a fastening, as well as the number of fastenings provided on the surface of plantar portion 48 may vary as needed.

The plantar valve 16 comprises a plantar shell 60 for securing plantar valve 16 in modular orthosis 10, together with bottom stock 62 for providing contact with the ground and support to the patient.

Plantar shell 60 has a plantar portion 64 corresponding to, and having a shape congruent with, the plantar portion 48 of the posterior valve 14. The plantar shell 60 also comprises an anterior section comprising a toe box 66, a mid-section comprising medial and lateral flanges 68 and a posterior section comprising a posterior flange 70. The toe box 66, medial and lateral flanges 68, posterior flange 70 and bottom stock 62 are secured to or are integral with the plantar portion 64.

Plantar shell 60 is provided with several lugs 72, similar to lugs 28, 52, spaced apart on medial and lateral flanges 68 and on posterior flange 70. Generally, the thickness of the plantar shell 60 is selected to provide some flexibility in the medial and lateral flanges 68 and posterior flange 70 during use, and the edge portions 74 of the medial and lateral flanges 68 and posterior flange 70 are thinner than the main portion 76 of plantar shell 60, for example having a tapered profile. In the disclosed embodiment, the edge portion 74 has a thickness of 0.002m (2mm) and main portion 76 has a thickness of 0.003m (3mm). In some embodiments, the toe box 66 is a strengthened toe box having increased a thickness, such as a thickness of 0.004m (4mm) for example.

The plantar portion 64 is provided with fastening 82 corresponding to the fastening 56. Typically, fastenings 56, 82 together comprise a releasable fastener 84 that restrains relative motion between the plantar valve 16 and posterior valve 14.

Clinically effective rockers, wedges and raises may be included in the biomechanical design of the bottom stock 62 by suitable size and/or shape and/or materials of the bottom stock 62.

In some embodiments plantar shell 60 and bottom stock 62 are made using the same material, but typically they are made of different materials. A suitable material for both plantar shell 60 and bottom stock 62 is polypropylene. In some embodiments, plantar shell 60 and bottom stock 62 are integral and/or manufactured together using an additive manufacturing technique to form the plantar valve 16. In other embodiments, different materials and manufacturing processes may be employed for manufacture of the plantar valve 16.

- 8 A method of fitting orthosis 10 will now be described in more detail with reference to Figure 10a to 10e and Figure 11.

In a first step 100 illustrated in Figure 10a, a surgically dressed limb of the orthosis user is fitted with a seam-free sock 90 up to the knee. The foot and leg of the user are fitted into the posterior valve 14, which contains an insole and protective padding (not shown) as clinically prescribed.

In a second step 102 shown in Figure 10b, the anterior valve 12 along with any further protective padding required (not shown) is fitted over the leading edge of the posterior valve 14, forming a bi-valve assembly enclosing and accommodating the surgically dressed limb, the insole and the protective padding. When the anterior valve 12 and posterior valve 14 are assembled, medial and lateral edges 34 overlap medial and lateral edges 54 as shown in Figure 6, and anterior valve toe portion 26 overlaps posterior valve toe portion 46 as shown in Figure 9. The bi-valve assembly is sized and shaped to provide appropriate support and correction to the patient.

In a third step 104, shown in Figure 10c, the sock 90 is turned down over the top of the bi-valve assembly and straps 18 used to secure the bi-valve assembly. Straps 18 pass through respective mid-line lugs 28 of the anterior valve 12 and respective medial and lateral lugs 52 on the posterior valve 14 and are secured by a releasable fastener at each end of respective straps 18.

In a fourth step 106, shown in Figure 10d, the bi-valve assembly is fitted to the plantar valve 16, and the plantar valve 16 is secured to plantar portion 48 of the posterior valve 14. The adjacent anterior valve toe portion 26 and posterior valve toe portion 46 are introduced into the toe box 66 and the heel is pushed down so that heel portion 44 fits to posterior flange 70 with a “click fit”, and releasable fastener 84 is engaged.

In a fifth step 108, as shown in Figure 10e, straps 18 secure the lower portion 24 and plantar shell 16 using lugs 28 and lugs 72 in a similar manner to that shown in Figure 6.

Contact between the posterior valve 14 and the plantar valve 16 is achieved at the adjacent surfaces of plantar portions 48, 64, which are typically congruent with corresponding shape. The plantar valve 16 and bottom stock 62 are located in a defined position relative to the posterior valve 14. Plantar valve 16 and bottom stock 62 are secured on posterior valve 14 so that relative movement within the orthotic system is substantially eliminated. This enables the assembled orthosis to reliably deliver the desired biomechanical effect despite the modular nature of the orthosis.

The fit between the posterior valve 14 and the plantar valve 16 is maintained in the anterior/posterior direction by the close fit of the anterior valve toe portion 26 and posterior

- 9 valve toe portion 46 into the strengthened toe box 66 of the plantar valve 16, and the opposed relationship of the heel portion 44 and posterior flange 70. Further, the fit is maintained mediolaterally by the medial and lateral flanges 68 together with the interaction of the straps 18 with lugs 72 of the plantar valve 16 and lugs 28 of anterior valve 12. Moreover, fastener 84 further contributes towards securing the plantar valve 16 to the posterior valve 14, substantially eliminating relative movement within the orthotic system.

An orthosis 110 in accordance with a second embodiment of the disclosure is shown in Figures 12 and 13.

Orthosis 110 is a modular orthosis typically comprising three main components: an anterior valve 112, shaped to enclose, support and protect the upper foot and shin of a patient; a posterior valve 114, shaped to enclose and support the calf and sole of the patient; and a plantar valve 116, providing a bottom stock for contacting the ground and supporting the patient, the bottom stock being shaped to provide biomechanical effects.

A plurality of straps 118 (shown in Figure 13) are provided to hold the anterior valve 112, posterior valve 114 and plantar valve 116 in the assembled state when fitted to a patient, providing boot-shaped orthosis 110 shown in Figure 13. Further, during use of the orthosis 110, an insole 120 is fitted within the posterior valve 114 to support a surgically dressed limb.

A tongue 126 is provided projecting outwardly forward from the edge of a lower portion 128 of anterior valve 112. In the disclosed embodiment, the lower portion 128 covers and protects the toes of the patient. A plurality of lugs 130 are provided at separated positions along the length of the anterior valve 112 to receive straps 118 when orthosis 110 is assembled. The lugs 130 are positioned along the central front portion of the anterior valve 112 corresponding to the shin of a patient.

Posterior valve 114 is provided with toe portion 134 at the foremost extremity of posterior valve 114, anterior to a patient toe region. Toe portion 134 defines an upper recess 136 having a reverse-facing opening 138 that is sized, positioned and oriented to receive and securely contains therein tongue 126 of the anterior valve 112. Toe portion 134 also defines a lower recess 142 having a reverse-facing opening 144 that is sized, positioned and oriented to receive and securely contain therein a tongue 160 of the plantar valve 116.

Posterior valve 114 is provided with a plurality of lugs 146 at separated positions along the length of an upper portion 148 of posterior valve 114, to receive straps 118 when orthosis 110 is assembled. In the disclosed embodiments, lugs 146 are positioned along the central back portion of the posterior valve 114 corresponding to the calf of a

-10 patient. A heel portion of the posterior valve 114 is provided with a protruding backwardly extending lip 150.

In the disclosed embodiment, plantar valve 116 comprises a plantar shell 162 for securing plantar valve 116 in modular orthosis 110, together with bottom stock 164.

The plantar shell 162 enables the plantar valve 116 to be located correctly and secured to the posterior valve 114 and comprises a plantar portion 168 together with medial and lateral flanges 170 arranged at either side of the plantar portion 168 and a posterior flange 172 arranged at the posterior edge of the plantar portion 168. In the disclosed embodiment, each of medial and lateral flanges 170 and the posterior flange 172 are provided with at least one eyelet or slot 174 therein to receive straps 118 in an assembled state.

Plantar portion 168 is provided with tongue 160 extending outwardly from the front end of plantar shell 162, the tongue 160 typically protruding from the plantar valve 116 in a direction generally parallel with the top of the bottom stock 164 such that, when the orthosis is assembled, tongue 160 engages with, and is securely contained within, lower recess 142 of toe portion 134.

The posterior flange 172 is flexible and can be fitted over lip 150 in response to an upward pressure when posterior flange 172 and the lip 150 are aligned, to secure the plantar valve 116 to the posterior valve 114. Equally, since posterior flange 172 is flexible, an outward force F1 (shown in Figure 13) applied outwardly at the top of the posterior flange 172 causes the posterior flange 172 to deform and come away from lip 150, enabling separation of the plantar valve 116 from posterior valve 114. The security of fit between posterior valve 114 and plantar valve 116 is maintained in an analogous manner to the first embodiment described above, for example by the inclusion of fastenings on the bottom plantar surface of posterior valve 114 and plantar portion 168 similar to fastenings 56, 82 shown in Figures 4 and 8. Typically, the fastenings on posterior valve 114 and plantar valve 116 (not shown) together comprise a releasable fastener that restrains relative motion between the plantar valve 116 and posterior valve 114.

In the disclosed embodiment, each of the anterior valve 112, posterior valve 114 and plantar valve 116 are manufactured using additive manufacturing techniques, such as 3D printing techniques. The anterior valve 112, posterior valve 114 and plantar valve 116 may be of any suitable materials selected by the skilled person that meet the strength and rigidity requirements. In one embodiment, one or more of the anterior valve 112, posterior valve 114 and plantar valve 116 are plastics material, for example, polypropylene.

A method of fitting orthosis 110 will now be described in more detail with reference to Figures 12 and 13.

-11 First, plantar valve 116 comprising a bottom stock 164 having a desired biomechanical effect is fitted to posterior valve 114 by inserting tongue 160 into opening 144 of toe portion 134. Thereafter, the plantar valve 116 is rotated towards posterior valve 114 and press fit to the posterior valve 114, causing posterior flange 172 to engage with lip 150 to attach the replacement plantar valve 116 to the posterior valve 114 securely. This provides an easy to use “slide and click fit” attachment mechanism.

The combined assembly of posterior valve 114 and plantar valve 116 is ready to receive therein insole 120 and protective padding as clinically prescribed, and to receive a surgically dressed limb of a patient fitted with a seam-free sock. Thereafter, the anterior valve 112, along with any further padding required (not shown), is fitted to posterior valve 114 by inserting tongue 126 into opening 138 of toe portion 134 and closing anterior valve 112 to posterior valve 116 so that the respective sides overlap. The sock is then turned down over the top of the assembled orthosis 110. Straps 118 passing through lugs 130, 146 and eyelet/slots 174 secure the assembled orthosis 110 ready for use, as shown in Figure 13.

The embodiments disclosed above provide an orthosis having a plantar valve 116 that is detachable from the orthosis. Since the plantar valve 116 is secured to the orthosis in a detachable manner, the bottom stock can be replaced or updated easily.

Contact between the posterior valve 114 and the plantar valve 116 is achieved at the adjacent surfaces of the bottom plantar surface of posterior valve 114 and plantar portion 168, which are typically congruent with corresponding shape. The plantar shell 162 and bottom stock 164 are located in a defined position relative to the posterior valve 114. Plantar valve 116 and bottom stock 164 are secured on posterior valve 114 so that relative movement within the orthotic system is substantially eliminated. This enables the assembled orthosis to reliably deliver the desired biomechanical effect despite the modular nature of the orthosis.

The fit between the posterior valve 114 and the plantar valve 116 is maintained in the anterior/posterior direction by the close fit of the tongue 160 into the reverse-facing opening 144 of toe portion 134, and the opposed relationship of the heel portion of the posterior valve 114 and posterior flange 172. Further, the fit is maintained mediolaterally by the medial and lateral flanges 170 together with the interaction of the straps 118 with eyelet/slots 174 of the plantar valve 116 and lugs 130 of anterior valve 112. Moreover, fastenings on the bottom plantar surface of posterior valve 114 and plantar portion 168 further contribute towards securing the plantar valve 116 to the posterior valve 114, substantially eliminating relative movement within the orthotic system.

-12 An alternative plantar valve 180 comprising a bottom stock in accordance with a third embodiment of the disclosure is now described with reference to Figures 14 and 15a to 15f.

In this embodiment, plantar valve 180 comprises a plantar shell 182 together with bottom stock 184 for providing contact with the ground and support to the patient. The bottom stock 184 is shaped according to a biomechanical design to provide a biomechanical effect during use.

The plantar shell 182 comprises a plantar portion 188 together with medial and lateral flanges 190 arranged at either side of the plantar portion 188 and a posterior flange 192 arranged at the posterior edge of the plantar portion 188. Each of mediolateral flanges 190 and the posterior flange 192 are provided with at least one eyelet or slot 194 therein to receive straps 118 in an assembled state of the orthosis. In the disclosed embodiment shown in Figure 14, mediolateral flanges 190 each have three slots 194, and the posterior flange 192 has two slots 194 to receive straps 118 in an assembled state. Plantar portion 188 is provided with tongue 196 extending outwardly from the front end of plantar shell 182. The plantar shell 182 of the third embodiment corresponds with the plantar shell 162 shown in Figures 12 and 13 and may be secured to posterior valve 114 of orthosis 110 in a similar manner, for example by the inclusion of fastenings on plantar portion 188, similar to fastening 82 on plantar portion 64 shown in Figure 8, that together with corresponding fastening on the posterior valve 114 comprises a releasable fastener that restrains relative motion between the plantar valve 116 and posterior valve 114. As a result, further detailed description of the plantar shell 182 and its contact and fit with posterior valve 114 is omitted for brevity.

Bottom stock 184 comprises a plurality of bottom stock components or bottom stock elements 1841, 1842, 1843 and 1844 arranged in successive layers on the bottom surface of plantar portion 188. The size and/or shape and/or materials of one or more of the bottom stock elements affect a biomechanical design of the bottom stock 184, so as to provide a biomechanical effect during use. Clinically effective rockers, wedges and raises may be included in the biomechanical design of the bottom stock by suitable size and/or shape and/or materials of one or more bottom stock elements, alone or in combination.

In the disclosed embodiment the bottom stock components 1841, 1842, 1843 and 1844 are generally planar layers arranged as a stack upon the outer surface of plantar portion 188. The outermost bottom stock component 1844 has a hardwearing and/or waterproof layer secured or bonded to the outer side. In the disclosed embodiment four bottom stock components 1841, 1842, 1843 and 1844 are provided, although in practice more than or fewer than four bottom stock components could be provided.

-13 At least one, and in the exemplary embodiment all, of the bottom stock components 1841, 1842, 1843 and 1844 are detachable from and re-attachable to or onto the plantar portion 188 of plantar shell 182. The bottom surface of plantar portion 188 is provided with releasable fastenings fixedly connected or adhered to the plantar portion 188 or integral with the plantar portion 188. Corresponding fastenings are disposed on respective facing sides of the plantar portion 188 and of the bottom stock components 1841, 1842, 1843 and 1844 forming releasable fasteners between the respective facing sides that secure the first bottom stock component 1841 to the plantar valve 180 and adjacent bottom stock components together in a releasable manner. Typically, each of bottom stock components 1841, 1842, 1843, 1844 comprises a core having fastenings on at least one of the planar sides of the core. In the disclosed embodiment, the core is a foam material, and the fastenings comprise releasable fastening elements to allow detaching of the bottom stock components. In some embodiments, each bottom stock component is 3D manufactured and comprises a planar foam core and integral fastening elements.

As shown in more detail in Figures 15a to 15d, the bottom stock components 1841, 1842, 1843 and 1844 are not uniform in shape, and in general the shape, size, and thickness of bottom stock components 1841, 1842, 1843 and 1844 are independent from each other. The shapes of the bottom stock components 1841, 1842, 1843 and 1844 in the disclosed embodiment are shown in Figure 15a to 15d.

The sizes, shapes, thicknesses and materials of the bottom stock components 1841, 1842, 1843 and 1844 are selected by a skilled person to create a bottom stock 184 having the desired biomechanical advantage. In some embodiments, bottom stock components 1841, 1842, 1843 and 1844 are cut and shaped from sheets of the core material. The sheets are stock sheets of different thicknesses and of core material of different densities. The cutting and assembly of the components 1841, 1842, 1843, 1844 may be done by a technician as prescribed by a clinician or the clinician may carry out this procedure themselves to create the bottom stock 184 having the desired biomechanical effect.

One great advantage of this process is the fact that the biomechanical effect can be tested in the assembly stage and adjusted in a “fitting and adjustment” process, before finishing off and supply the same day. The final detail of the assembly and the effects of wear after a time period decided by the clinical prescriber can then be quickly and easily assessed and a second plantar valve and bottom stock can be 3D printed and efficiently interchanged because of the component design of the plantar shell quick click-fit process.

-14 The alternative plantar valve 180 disclosed in Figure 14 and Figures 15a to 15d can be used in orthosis 110 shown in Figures 12 and 13 in place of disclosed plantar valve 116, as will be apparent to a skilled person. Equally, the modular bottom stock 184 described above may be attached to plantar shell 60 as a replacement for bottom stock 62 in the plantar valve 16 described above with reference to Figures 1 to 11. Further, in some embodiments, the plantar shell 60, 182 is omitted entirely, and a bottom stock having a plurality of detachable bottom stock components 1841 to 1844 may be applied directly to the plantar portion 48 of posterior valve 14.

A method 200 of updating an orthosis in accordance with embodiments of the disclosure will now be described with reference to Figure 16.

In some situations, for example during repair of the orthosis, a new bottom stock has the same biomechanical effect as the original bottom stock. In other situations, for example in situations where the biomechanical need of the patient has changed, the new bottom stock has a different biomechanical effect from the original bottom stock.

In a first step 202, a plantar component comprising a bottom stock component is detached from the modular orthosis.

In a second step 204, a new plantar component is obtained. The new plantar component may be obtained from stock or may be obtained by manufacturing a new plantar component or by replacing or modifying an existing plantar component. Typically, the new plantar component has a securing mechanism and/or has fastenings the same as or functionally equivalent to the securing mechanism or fastenings of the original plantar component.

In a third step 206, the replacement plantar component is secured to provide an updated orthosis.

In more detail, in orthosis 10, the plantar component is the plantar valve 16. To update orthosis 10, the plantar valve 16 is detached from the posterior valve 14 of the assembled orthosis 10 shown in Figure 9 and Figure 10e after removal of the lowermost four straps 18 by pulling outwardly and downwardly on posterior flange 70, causing the releasable fastener 84 to unfasten and the plantar valve 16 to detach and separate from the posterior valve 14. A forward movement of the plantar valve 16 relative to the posterior valve 14 enables the toe box 66 to clear the toe portions 26, 46 to release the plantar valve 16.

In the disclosed embodiment, a new plantar valve 16 having a bottom stock shaped to provide the required biomechanical effect is manufactured, for example using an additive manufacturing technique. Typically, the new plantar valve 16 is provided with locating and securing connecting elements, namely one or more of plantar shell 60; toe

-15 box 66; medial and lateral flanges 68; posterior flange 70; lugs 72; and fastening 82, that are functionally equivalent or are identical to the corresponding features of the original plantar valve 16.

Thereafter, the new plantar valve 16 is attached to the posterior valve 14 as described above with reference to Figure 10d and 10e.

In orthosis 110, the plantar component is the plantar valve 116. To update orthosis 110, the plantar valve 116 is detached from posterior valve 114. In different embodiments, this may be from an assembled orthosis or after preliminary removal of the anterior valve 112 from an assembled orthosis or partial-foot prosthesis (an ortho-prosthesis), for example. As described above, a force F1 applied outwardly to the posterior flange 172 of plantar valve 116 causes the posterior flange 172 to separate from lip 150 of the posterior valve 114. At this time, the posterior valve 114 and the plantar valve 116 are still attached by the tongue 160 held in the recess 144. Thereafter, a rearward and downward force applied to the plantar valve 116 causes tongue 160 to slide out of the recess 144, thus separating posterior valve 114 and plantar valve 116.

In the disclosed embodiment, a new plantar valve 116 having a bottom stock 164 shaped to provide the required biomechanical advantage is manufactured using an additive manufacturing technique. Typically, the replacement plantar valve 116 is provided with one or more securing elements, namely plantar shell 162 and/or tongue 160, mediolateral flanges 170; posterior flange 172; eyelets 174 that are functionally equivalent to or are identical to the corresponding features of the original plantar valve 116.

Thereafter, the new plantar valve 116 is attached to the posterior valve 114 as described above.

In the plantar shell 180 shown in Figures 14 and Figures 15a to 15d, the plantar component is any one of the bottom stock components 1841 to 1844 that together make up the bottom stock 184. To update the orthosis, bottom stock component (s) 1841 to 1844 are detached from the posterior valve 116/plantar valve 180 assembly, for example by separating the fasteners securing the bottom stock components 1841 to 1844 from each other and/or from the plantar portion 188.

Thereafter, in some embodiments, one or more of the bottom stock components 1841 to 1844 is modified by, for example, reducing the length, breadth or outline shape of the bottom stock components 1841 to 1844 to obtain a new bottom stock component for inclusion in the new bottom stock 184. Alternatively, or additionally, one or more new bottom stock components 1841 to 1844 are obtained for inclusion within a new bottom stock, whether with or without modification. Additionally, one or more of the original bottom stock components 1841 to 1844 may be re-used in the new bottom stock 184.

-16 Typically, the modified or the new bottom stock components 1841 to 1844 are provided with the same fastening mechanism, for example a TAG fastener, enabling selected bottom stock components 1841 to 1844, typically including at least one new or modified element, to be assembled using the TAG fasteners as new bottom stock 184.

Once a satisfactory bottom stock is created, the bottom stock components may be permanently adhered to each other, to create a useable bottom stock. A bottom stock having the required biomechanical features may be manufactured and swapped.

The use of additive manufacturing techniques in some embodiments of the disclosure is described below with reference to Figures 17 and 18.

Figure 17 is a schematic diagram of the main elements of an apparatus 220 for manufacturing an orthosis 10, 110, or components of an orthosis. As will be readily understood by a skilled person, a detailed explanation of elements of apparatus 220 has been omitted for clarity.

Apparatus 220 comprises a 3D scanner 222; a processing unit 224 comprising a processor 226 and a data store 228, a user interface 230 and a 3D printer 232.

3D scanner 222 is coupled to processing unit 224 to store patient measurement data generated in a scanning operation in data store 228. User interface 230 is coupled to data store 228 to enable a system operator to enter biomechanical effect data into the data store 228. 3D printer 232 is coupled to data store 228 to receive a new orthosis specification comprising at least a plantar valve 16, a plantar valve 116 or plantar shell 182.

Processor 226 controls operation of the apparatus 220 and operates on the data stored in data store 228 in accordance with the method described with reference to Figure 16 to generate a new orthosis specification.

A method of manufacturing an orthosis will now be described in more detail with reference to Figure 18.

In a first step 240, a 3D scan of a limb of a patient and surgical stocking is carried out, and the resulting data stored.

In a second step 242, information relating to the required bottom stock shape and/or desired biomechanical effect of the orthosis is input.

In a third step 244, the acquired patient data and bottom stock information are used to determine a new orthosis specification for the required dimensions, and possibly the required materials, of one or more components of an orthosis, for example anterior component 12, posterior component 14 and plantar component 16 of a new modular orthosis 10.

-17 In a fourth step 246, one or more components of the new orthosis are 3D printed according to the orthosis specification. Further, any elements that are not 3D printed, can be added at this time in optional step 248.

Typically, the orthosis specification is retained in the data store 228, for further use.

As mentioned, it is sometimes necessary to replace one or more components of the orthosis, for example to replace worn components, or to update the orthosis in response to changing biomechanical or cosmesis requirements of the user.

If the orthosis is updated to replace a worn bottom stock, it may not be necessary to measure or re-scan the user. Instead a replacement plantar valve 16, 116 comprising bottom stock 62, 164 having the same biomechanical effect as a previous bottom stock 62, 164 can be manufactured from the data stored in data store 108.

As will be understood by a skilled person, the described embodiments are presented as non-limiting examples, and aspects of the described embodiments can be combined or omitted as appropriate.

The straps 18, 118 typically comprise touch and close (TAG) fasteners. The straps 18, 118 allow for some volume adjustment within the orthosis, and are easily replaceable. The straps 18, 118 are fed through purpose designed openings which enable any strap to be a right- or left- hand closure. Other embodiments may use other methods to releasably secure the orthosis assembly.

The releasable attachment of the plantar valve to the posterior valve can be provided in alternative ways in accordance with different embodiments. In a first alternative embodiment, releasable fastener elements are disposed on one portion of or on multiple portions of, or across a substantial part of, the facing surfaces of the posterior valve and the plantar valve. In embodiments, releasable fasteners comprise shearresistant fasteners that are relatively easily separated when a force perpendicular to an interface surface is applied but are more resistant to shear forces applied along the interface surface. In one example, a releasable touch and close (TAG) fastener comprises hook and loop materials fastener such as Velcro™. In some embodiments, shear-resistant fasteners may comprise mushroom-shaped, shard-like or similarly shaped elements disposed on opposing surfaces. Such elements may be interlocking elements.

Other securing mechanisms can be envisaged by a skilled person within the scope of the present invention. For example, a plurality of corresponding male and female socket sections disposed on facing surfaces of the plantar component and the posterior component may be provided, enabling a push-fit or press fit attachment.

-18 The releasable attachment of bottom stock components can be provided in alternative ways in accordance with different embodiments. In one alternative embodiment, releasable fastening elements are disposed on respective faces of bottom stock components forming releasable fasteners. Releasable fasteners may be shearresistant and relatively easily separated when a force perpendicular to an interface surface is applied but are more resistant to shear forces applied along the interface surface. In one example, a releasable touch and close (TAG) fastener comprises hook and loop materials fastener such as Velcro™. In some embodiments, releasable TAG fasteners may comprise mushroom-shaped, shard-like or similarly shaped elements disposed on opposing surfaces. Such elements may be interlocking elements. In different embodiments, the fastenings are separate from the core material sheet and adhere or are otherwise fixed to the plane surfaces of the core material sheet or are integral with the core material sheet.

The disclosed embodiments provide an orthotic device having an adjustable and/or replaceable bottom stock. The disclosed orthotic device and orthotic methods enable patient outcomes to be improved and/or cost of orthotic treatment to be reduced.

Embodiments of the invention provide a modifiable or adjustable device that enables a bespoke orthosis to be made that can be efficiently and cost-effectively adapted to a user. Changes can be made to different components to provide functional variation without a requirement for a new orthosis. The modular orthosis accommodates a change of dressing and/or clinical stockings of different thicknesses, and changes of shape and volume of patient limbs due to further surgical procedures. Further, change of bottom stock bio-mechanics, for example to accommodate changes in pitch, can be achieved. As a result, the biomechanical effect of the orthosis 10 can be readily adapted to the changing needs of the patient simply by modifying or replacing one or more components of the orthosis. In addition, the modular nature of the orthosis enables easy replacement of worn components.

Moreover, significant changes to the bio-mechanics of the orthosis and/or repair of the orthosis can be achieved in such a way that a patient is not deprived of the use of the device. Different components can be replaced or changed in clinic as needed without taking away the orthosis from the patient.

As a result, the orthoses can be readily adapted to the changing needs of patients, leading to better clinical outcomes for patients as well as a more convenient orthotic process as a whole. Further, the cost of the individual orthosis as well as the overall cost of the orthotic treatment is reduced, since an outdated or worn bottom stock can updated simply by replacing the bottom stock component.

-19 Better patient outcomes lead to more efficient use of high cost hospital bed space and of subsequent outpatient clinical time, leading to a reduction in cost of orthotic treatment.

The plantar component may be restrained from moving in the posterior/anterior direction by elements locating the plantar component relative to the rest of the orthosis, for example by the posterior flange and toe box, or by the posterior flange and tongue/toe portion. The plantar component may be located and restrained from moving mediolaterally by elements locating the plantar component relative to the rest of the orthosis, for example by the medial/lateral flanges.

Movement of the bottom stock relative to the rest of the orthosis is restrained both medio-laterally, and also in the posterior/anterior direction by shear-resistant fastenings, ensuring that the relative position and alignment is maintained and resulting in consistent biomechanical effect.

The congruency of shape between plantar shell of the plantar component and the posterior component assists in maintaining relative position and/or alignment between plantar component and posterior component, resulting in consistent biomechanical effect

The use of additive manufacturing techniques in some embodiments contributes to a more sustainable future by enabling recycling of the material used to make components of the orthoses. Moreover, recycling worn or outdated components may reduce the overall cost of the orthotic treatment.

In some embodiments, the use of additive manufacturing techniques facilitates swift manufacture and rapid deployment of new components, resulting in improved client outcomes. In particular, in some embodiments a new bottom stock may be prepared while a patient attends clinic, providing a convenient and cost-effective service and contributing to improved patient outcomes.

The use of additive manufacturing techniques enables the anterior valve and posterior valve to be provided with perforations to improve breathability. Additive manufacturing techniques enable the thickness and material of different parts of the orthosis to be selected to provide the desired flexibility and strength, reducing cost and increase wear-ability of the orthosis.

Moreover, the use of tapered edges for anterior valve and posterior valve allows relative movement during fitting, enabling changes in volume of the contained limb to be accommodated.

In embodiments where the detachable plantar component is a component of the bottom stock, the biomechanical advantage of the orthosis is controlled directly in clinic as needed and can be tested immediately. In some cases, the biomechanical need of a

- 20 patient can change from week to week, and this changing biomechanical need can be catered for at clinic to facilitate continuity of orthotic treatment.

The addition and subtraction of different modular bottom stock components comprising layers made from the same basic TAC material-covered foam in disclosed embodiments provides a facility for adjustment of the heel to fore-foot pitch (i.e. difference in height) and/or rocker sole adjustment. This enables the position of the rocker and the height of the rocker to be adjusted in clinic very quickly simply by trimming and cutting from a bottom stock component outline, for example a 6mm foam with the TAC material top and bottom.

In some cases, the depth of bottom stock on the affected limb side will be minimal, as only a very slight rocker or even just an exaggerated toe spring may suffice to give an acceptable and safe gait pattern. This means that if the limb lengths are equal or the contra limb is longer than the affected side, no special contra balancing footwear will be needed, as the patient’s own footwear (for example, shoes, sandals, slippers) can be used.

This saves clinical and workshop time and, in some cases, also the cost of contra balancing footwear. The fit and function of the orthosis can be determined in a single clinic visit, enabling the number of outpatient attendances to be reduced significantly. Patient outcomes can be improved and the cost of the orthotic services reduced.

As will be appreciated by a skilled person, the principles of the invention can also be applied to other orthotic device types such as patella tendon orthosis with minimal adaptation. The foot of the patient is considered to be supported by the orthosis components whether the weight of the patient is supported in part directly by the foot, or is supported by compression of the patient’s calf or patella tendon.

As will be appreciated by a skilled person, although the above description relates primarily to orthoses, the principles are also applicable to and should be understood as relating to prosthetic devices, especially for use with diseased, congenital or post-surgical partial feet. Accordingly, the terms “orthotic device” or “orthotic methods” should be understood to relate to both orthoses and to prosthetic devices.

Claims

1. An orthotic device having a bottom stock comprising one or more bottom stock components, the orthotic device comprising, a first component for supporting at least the foot of a user, and a plantar component comprising a bottom stock component, the plantar component being locatable on and secured to the first component in a secured state, and being detachable from the first component.

2. The orthotic device as claimed in claim 1, wherein the first component and the plantar component respectively comprise corresponding locating element(s) for reliably positioning the plantar component relative to the first component in the secured state.

3. The orthotic device as claimed in any preceding claim where, in the secured state, the bottom stock is reliably located at a determined position within the orthotic device.

4. The orthotic device as claimed in any preceding claim, wherein the first component and the plantar component respectively comprise corresponding connectors configured to locate the plantar component on the first component and to connect the plantar component to the first component in a detachable manner.

5. The orthotic device as claimed in any preceding claim, wherein the first component and the plantar component respectively comprise corresponding connectors where the connectors comprise a releasable fastener having releasable fastening elements on corresponding plantar portions of the first component and the plantar component.

6. The orthotic device as claimed in any preceding claim, wherein the first component and the plantar component have respective plantar portions, the respective plantar portions having corresponding shapes such that the plantar component and first component fit together in a congruent manner when the plantar component is secured to the first component.

7. The orthotic device as claimed in any preceding claim, wherein the plantar component comprises a plantar shell and the bottom stock secured to the plantar shell, the plantar shell being securely locatable on the first component and being detachable from the first component.

8. The orthotic device as claimed in claim 7, wherein the bottom stock comprises a plurality of bottom stock components in a stack formation on the plantar shell, each of the bottom stock components comprising fastenings for detachably fastening the bottom stock component to the plantar shell and/or at least one other plantar component.

9. The orthotic device as claimed in claim 1, wherein the bottom stock comprises a plurality of bottom stock components in a stack formation on the first component, each of the bottom stock components comprising fastenings for detachably fastening the bottom stock components to the first component and/or at least one other bottom stock component.

10. The orthotic device as claimed in any preceding claim, wherein the size and/or shape and/or materials of one or more bottom stock component(s) provide the bottom stock with at least one of a rocker, a wedge and a raise.

11. The orthotic device as claimed in any preceding claim, wherein the bottom stock component and respective fastenings comprise 3D printed material and are integrally formed.

12. The orthotic device as claimed in any preceding claim, wherein one or more of the first component and the plantar component comprises 3D printed material.

13. The orthotic device as claimed in any preceding claim, further comprising a second component configured to co-operate with the first component to support and/or contain the foot and/or leg of a patient.

14. The orthotic device as claimed in any preceding claim, wherein the first component and the second component have respective tapering edges that overlap when the first component and second component are assembled to support and/or contain the foot and/or leg of a patient.

15. A plantar component for an orthotic device as claimed in any preceding claim, the plantar component comprising: at least one bottom stock component and securing elements for securely locating the plantar component on the first component of the orthotic device in a detachable manner.

16. The plantar component as claimed in claim 15 comprising 3D printed material.

17. A method of forming a new orthotic device having a bottom stock comprising one or more bottom stock components, the orthotic device comprising a first component adapted to support at least the foot of a user and a plantar component comprising a/the bottom stock component(s), the plantar component being connected to the first component in a secured state and being detachable from the first component, the method comprising:

connecting a new plantar component to a first component to create the new orthotic device comprising the first component and the new plantar component.

18. The method as claimed in claim 17, wherein the step of connecting the new plantar component to the first component reliably locates the bottom stock of the orthotic device at a determined position within the orthotic device

19. The method as claimed in any one of claims 17 or 18, the method further comprising an initial step of detaching an existing plantar component from the first component.

20. The method as claimed in any one of claims 17 to 19, the method further comprising additive manufacturing the new plantar component.