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Title:
AN ORTHOTIC BOOT
Document Type and Number:
WIPO Patent Application WO/2016/203250
Kind Code:
A1
Abstract:
An orthotic boot (1200) arranged to substantially immobilise the foot and ankle of a wearer, comprising a rigid sole portion, in which there is mounted a bladder, and an upper(25). The rigid sole portion has a rocker sole. The upper (25) is arranged so as to conceal a substantial portion of the thickness of the sole.

Inventors:
HERRON, Mark (BMI Priory Hospital Priory Hospital,Priory Road, Edgbaston, Birmingham B5 7UG, B5 7UG, GB)
Application Number:
GB2016/051806
Publication Date:
December 22, 2016
Filing Date:
June 16, 2016
Export Citation:
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Assignee:
THE FOOT & ANKLE CLINIC LTD (BMI Priory Hospital, Priory HospitalPriory Road, Edgbaston, Birmingham West Midlands B57UG, B57UG, GB)
International Classes:
A61F5/01; A43B7/20; A43B13/18; A43B13/20
Foreign References:
GB2462100A2010-01-27
US20030046831A12003-03-13
US5378223A1995-01-03
EP1956932A22008-08-20
Attorney, Agent or Firm:
BARKER BRETTELL LLP (100 Hagley Road, Birmingham B168QQ, B168QQ, GB)
Download PDF:
Claims:
CLAIMS

1 An orthotic boot

the boot being arranged to substantially immobilise the foot and ankle of a wearer, the boot comprising:

a rigid sole portion, in which there is mounted a bladder, the rigid sole portion having a rocker sole; and

an upper, wherein the upper is substantially rigid;

the bladder comprising a gas impermeable membrane, containing a plurality of pellets and having a valve arranged to allow the bladder to be filled and evacuated; wherein the sole portion has a thickness and the upper is arranged such that it is mounted on the sole portion so as to conceal a portion of the thickness of the sole portion. 2. An orthotic boot according to claim 1 wherein the upper is arranged to conceal a substantial portion of the thickness of the sole portion.

3. An orthotic boot according to claim 1 or claim 2 wherein the upper and sole portion are arranged to allow at least partial uni-planar flexion and/or extension.

4. An orthotic boot according to any preceding claim wherein the upper and sole portion are arranged to substantially prohibit flexion of the ankle joint beyond a controlled amount of movement. 5. An orthotic boot according to any preceding claim wherein the sole portion comprises a stiffening shank, wherein preferably the shank is made out of carbon fibre.

6. An orthotic boot according to any preceding claim wherein the upper overlaps the sole portion.

7. An orthotic boot according to claim 6 wherein the sole portion is inwardly stepped to accommodate the overlapping upper.

8. An orthotic boot according to any preceding claim wherein the bladder is recessed into the sole portion.

9. An orthotic boot according to any preceding claim wherein the boot is rear opening.

10. An orthotic boot according to any preceding claim wherein a tongue of the boot is low-opening.

1 1. An orthotic boot according to any preceding claim wherein the upper comprises articulated panels.

12. An orthotic boot according to claim 1 1 wherein the panels of the upper can move laterally relative to each other. 13. An orthotic boot according to claim 12 wherein the panels of the upper are connected by elastic material.

14. An orthotic boot according to any preceding claim wherein lining material is provided within the upper of the boot such that, in use, the lining material is situated between the upper and a foot of a wearer.

15. An orthotic boot according to claim 14 wherein the lining comprises articulated panels. 16. An orthotic boot according to claim 15 wherein the articulated panels of the lining are distinct from the articulated panels of the upper.

17. An orthotic boot according to claim 15 or claim 16 wherein the panels of the lining can move laterally relative to each other.

18. An orthotic boot according to any one of claims 15 to 17 wherein the panels of the lining are connected by elastic material.

19. An orthotic boot according to any preceding claim wherein the upper substantially rigidly connected to the sole portion.

20. An orthotic boot according to any preceding claim wherein an insole allowance provided, with a depth substantially in the region of 1.5 cm to 3.5 cm. 21. An orthotic boot, comprising an upper arranged to receive a wearer's foot, wherein the upper comprises a plurality of panels connected to one another by elastic material, wherein the panels move laterally relative to each other via the elastic material stretching and contracting. 22. An orthotic boot according to claim 21 wherein the panels are made of a substantially rigid material.

23. An orthotic boot according to claim 2 lor claim 22 wherein the elastic material is substantially continuous, and wherein preferably the elastic material substantially covers the inner surface of the upper.

24. An orthotic boot according to any of claims 21 to 23 wherein the panels are connected by strips of the elastic material. 25. An orthotic boot according to any of claims 21 to 24 wherein the elastic material is one of the following:

(i) a thermoplastic elastomer; or

(ii) rubber. 26. An orthotic boot according to any of claims 21 to 25 wherein the panels can move apart by a maximum of substantially one of the following distances: 2 mm, 5 mm, 8 mm, 10 mm, 15mm.

27. An orthotic boot according to any of claims 21 to 26 further comprising a lining material, which, in use, is between the upper and a foot of a wearer.

28. An orthotic boot according to claim 27 wherein the lining material is as described in any of claims 1 1 to 14.

29. An orthotic boot the boot being arranged to substantially immobilise the foot and ankle of a wearer the boot comprising:

a rigid sole portion, wherein the sole portion is a rocker sole;

a bladder mounted in the rigid sole portion; and

a stiff upper.

30. The orthotic boot of claim 29 wherein the bladder comprises a gas impermeable membrane containing a plurality of pellets and having a valve arranged to allow the bladder to be filled and evacuated.

3 1. The orthotic boot of claim 29 or claim 30 wherein the sole portion has a thickness and the upper is arranged such that it is mounted on the sole portion so as to conceal a substantial portion of the thickness of the sole portion. 32. An orthotic boot according to any preceding claim in which the substantially rigid upper has an at least substantially horizontal cut-away portion at ankle level extending from where the upper meets the tongue towards the back of the boot so as to form a functional hinge allowing controlled movement of the ankle . 33. An orthotic boot according to any preceding claim having an upper rear collar section made of a flexible material, and wherein the substantially rigid upper does not extend substantially into the rear collar section.

34. An orthotic boot according to any preceding claim having the apex of the curve on the rocker sole located between 56% to 60% of the length of the boot forward from the heel of the boot.

35. An orthotic boot according to claim 34 wherein the apex of the curve on the rocker sole is located substantially 58% of the length of the boot forward from the heel of the boot.

36. An articulated upper as described in any of claims 21 to 28, suitable for use in an orthotic boot.

Description:
AN ORTHOTIC BOOT

This invention relates to an article of orthotic footwear and related methods. More particularly it concerns a type of orthotic boot that can be adapted to the shape of a wearer's foot whilst restricting movement of the foot and ankle . The invention may have particular application in post-operative recovery, but it need not be limited to this use .

There are various designs of post-operative boots available for rehabilitation after injury or operation to the foot and ankle . Most designs incorporate a stiff 'through- rocker' type sole and design elements to support, offload and immobilise the foot and ankle . These current systems are required for a period of approximately three months after an injury and/or operation. During this time the foot and/or ankle and/or lower leg needs protection from knocks and maximum support to maintain the foot and/or ankle and/or lower leg in a set position.

After approximately three months however (when the foot and/or ankle and/or lower leg are usually more robust) currently available orthopaedic rehabilitation/postoperative boots become less useful. Their large size and inflexibility not only become unnecessary and restrictive, but may stigmatise the patient; who is made to feel like an invalid for longer than is necessary. The inflexibility of the boot may even prolong muscle atrophy as the patient may be unnecessarily prevented from 'exercising' the foot and lower limb more generally by the rigidity and size of the boot. In addition, currently available orthotic boots are visibly medical implements, not normal footwear, and so draw attention to their use, which may frustrate and further stigmatise the patient. The unusual and un-aesthetic appearance of such available orthotic boots is a frequent complaint from those obliged to wear them.

Due to their cumbersome nature, post-operative boots are almost invariably supplied as a unilateral device, which also causes difficulty in finding footwear of appropriate sole height and design for the untreated side. Failure to compensate for any unilateral leg length discrepancy can cause a patient extreme discomfort and/or difficulty in walking, and may lead to injury or refusal to wear the post-operative boot. After significant injuries or operations, a patient is rarely ready, after a period of three months, to resume normal walking with normal footwear and would benefit from continued mechanical and functional support. Patients with a wide range of chronic degenerative conditions of the foot and ankle (including ankle arthritis and tendon disease of the Achilles and Tibialis posterior tendon) can suffer similar, although permanent, deterioration to their foot and ankle .

World-wide there currently exists no shoe-wear product designed to specifically address the needs of either of these significantly sized patient groups.

According to a first aspect, there is provided an orthotic boot arranged to substantially immobilise the foot and ankle of a wearer. The boot typically comprises a rigid sole portion, in which there is mounted a bladder, and an upper.

Advantageously, the bladder comprises a gas impermeable membrane, containing a plurality of pellets and has a valve arranged to allow the bladder to be filled and evacuated. The valve may be connected directly to the bladder or may be connected to the bladder via a tube or the like .

The sole portion of the boot has a thickness and the upper is advantageously arranged such that it is mounted on the sole so as to conceal a portion of the thickness of the sole . The portion of the thickness of the sole concealed may be substantially the entire thickness of the sole .

The sole portion possesses a rocker formation in some embodiments, thereby providing a rocker sole . Advantageously, this allows a wearer to tilt forwards and backwards more easily, while still maintaining weight on the foot, so reducing load on a wearer' s joints.

In embodiments with a rocker sole, one or more sections of the rocker sole, generally between a heel portion and the rest of the sole, may be removed, leaving a rib to maintain the rocker sole functionality - the rib conforms to the curvature of the through-rocker sole. Two outer portions of the rocker sole are removed in some embodiments, leaving a central rib which curves continuously from the heel portion to the toe. Advantageously, this may allow the boot to have a more normal appearance, with a discreet heel, whilst maintaining the rocker sole functionality.

In alternative embodiments, a single outer portion may be removed, leaving a rib on the centre and instep of the sole, so giving a more normal appearance on the side of the boot more likely to be seen only. Such embodiments are also likely to be lighter and perhaps therefore easier for a wearer to use.

The sole portion may conveniently comprise a stiffening shank. The shank is preferably made out of a strong, light-weight material, such as carbon fibre to reduce the flexibility of the sole portion.

The upper overlaps the sole portion in at least some embodiments. Conveniently, this disguises the true thickness of the sole portion, so giving the orthotic boot an appearance more similar to that of a normal boot. In some embodiments wherein the upper overlaps the sole portion, the sole portion is inwardly stepped to accommodate the overlapping upper.

The bladder may be recessed into the sole portion. Advantageously, this reduces the depth of the sole portion whilst maintaining the customisable support offered by the bladder.

The orthotic boot may be rear opening. The rear opening may be provided by fastening means on the heel portion, such as hook and eye fasteners, a zip, buttons, or laces. The skilled person will appreciate that other fastening means are available .

In alternative or additional embodiments, a front tongue of the boot is low-opening. Alternatively or additionally, the orthotic boot may be fully opening, with a front portion which can be folded forward to allow access to the boot. Advantageously, a low-opening tongue and/or rear opening of the boot provide more comfortable access to the boot for a foot of a wearer.

Conveniently, the upper may comprise articulated panels. The articulated panels of the upper can conveniently move laterally relative to each other. This may advantageously allow the upper of the boot to expand so as to accommodate swelling and relieve pressure on a foot of a wearer.

In embodiments comprising articulated panels, the panels of the upper may be connected by elastic material. The material used may be elastic, elasticated fabric, Lycra (RTM), neoprene or any other resilient material known to one skilled in the art.

A lining material may be provided within the upper of the boot such that, in use, the lining material is situated between the upper and a foot of a wearer. Advantageously, this improves the comfort of a wearer, cushions sensitive areas and/or accommodates swelling.

In embodiments comprising a lining, the lining may comprise articulated panels. Advantageously, this increases the flexibility of the lining, so allowing more adjustment to the foot of a user.

The articulated panels of the lining of these embodiments may be distinct from the articulated panels of the upper. Conveniently, the panels of the lining can move laterally relative to each other. The movement of the panels may advantageously allow swelling to be accommodated.

The panels of the lining may be connected by elastic material. The material used may be elastic, elasticated fabric, Lycra (RTM), neoprene or any other resilient material known to one skilled in the art.

The upper may be substantially rigid, and, conveniently, the upper may be rigidly connected to the sole portion. Advantageously, the ankle joint is substantially immobilised by the combination of the substantially rigid upper and the rigid sole portion. The skilled person would understand that, for the purposes of comfort, a limited amount of movement may be allowed at the ankle . In such embodiments, the substantially rigid upper and the rigid sole portion may have an articulated portion which allows a small amount of rotation and/or flexion of the ankle joint.

For example, rotation and/or flexion of the ankle joint may be limited to one or more of the following degrees, or the like, 4°, 5°, 10° or 15° (ie a controlled amount of movement) . Movement of the ankle joint is therefore restricted by the combination of the substantially rigid upper and the rigid sole portion.

Advantageously, movement may be restricted to predominantly uni-planar flexion and/or extension; ie in a plane allowing toes to be moved up and down with respect to the ankle (flexion and/or extension of the ankle) . However, embodiments are typically arranged to prevent large amounts of flexion or extension of the ankle joint (ie movement greater than the controlled amount is prevented) . In this way, movement is restricted to predominantly uniplanar flexion/extension. The small movements required for comfortable walking can therefore be performed without overly stretching or straining the ankle. Conveniently, an insole allowance is provided within the boot. The depth of the insole allowance may be substantially in the region of 1.5 cm to 3.5 cm.

An advantage of such an article of footwear is that it can be contoured to a wearer' s foot thereby providing customised support. The shape, contours and volume of a patient's foot many vary significantly both day to day and over the course of a single day in up to the first six months after surgery/trauma, or indefinitely in the case of chronic degenerative conditions. The design allows this to be catered for dynamically as required. According to a second aspect, there is provided an orthotic boot, comprising an upper arranged to receive a wearer's foot, wherein the upper comprises a plurality of panels connected to one another. Conveniently, the, or each, connection between the panels comprises elastic material. The panels may move laterally relative to each other via the elastic material stretching and contracting. Advantageously, this allows the upper to expand to accommodate swelling of a foot of a user.

Conveniently, the panels are made of a substantially rigid material.

The panels may be connected by strips of the elastic material. The strips of elastic material are advantageously arranged substantially along the seams 900 between panels 902. Advantageously, the elastic connections between the panels allow some relative rotation of the panels, in addition to lateral translation.

In alternative embodiments, the panels may be connected to a continuous elastic material which substantially covers the inner surface of the upper of the boot.

The elastic material used may be one of the following, or may alternatively be any suitable resilient material known to one skilled in the art:

(i) elastic;

(ii) neoprene;

(iii) Lycra (RTM).

Conveniently, the panels can move apart by a maximum of substantially one of the following distances: 2 mm, 5 mm, 8 mm, 10 mm, 15 mm, 20 mm. In some embodiments, the boot further comprises a lining material, which, in use, is between the upper and a foot of a wearer.

The lining material may have any of the features described for the lining material of the first aspect.

In a third aspect, there is provided an articulated upper, as described above, suitable for use in an orthotic boot.

The skilled person will appreciate that features discussed in relation to any one aspect of the invention may be provided with any other aspect of the invention. According to a fourth aspect, there is provided an orthotic boot arranged to substantially immobilise the foot and ankle of a wearer. The boot typically comprises a rigid sole portion, in which there is mounted a bladder, and an upper.

Advantageously, the rigid sole portion is a rocker sole . Further, the upper may be stiff. In at least some embodiments, the foot and the ankle joint are substantially immobilised by the combination of the stiff upper and the rigid sole portion. The rocker sole is designed to allow a wearer to tilt forwards and backwards more easily, while still maintaining weight on the foot. The skilled person would understand that the rocker sole therefore reduces load on a wearer's joints. Rocker soles typically have a curvature along their length which allows tilting to occur without bending of the foot and/or ankle .

In some embodiments, the bladder comprises a gas impermeable membrane, containing a plurality of pellets. Advantageously a valve is provided and arranged to allow the bladder to be filled and evacuated. The sole portion of the boot has a thickness and the upper is advantageously arranged such that it is mounted on the sole so as to conceal a substantial portion of the thickness of the sole .

Embodiments of the invention will now be described in more detail by way of example only with reference to the accompanying drawings in which:

Figure 1 is an exploded perspective view of a boot of one embodiment, showing a sole portion and a bladder of an article of footwear; Figure 2 shows a longitudinal cross-section through the sole portion of Figure 1 along line XX;

Figure 3 is a cross-section through the bladder of Figure 1 along line YY thereof; Figure 4a is a cross-sectional view through the sole portion of Figure 1 along line ZZ, also showing a portion of an upper of the boot;

Figure 4b is a cross-sectional view through the sole portion of an alternative embodiment, showing a second method of connecting the upper to the sole portion;

Figure 4c is a cross-sectional view through the sole portion of a further alternative embodiment, showing a third method of connecting the upper to the sole portion;

Figure 4d is a perspective cut-away view through the sole portion of a further alternative embodiment, showing a fourth method of connecting the upper to the sole portion;

Figure 4e is a cross-sectional view of the cut-away edge of an article of footwear similar to that shown in Figure 4d but with a larger welt;

Figure 5 is a view of the sole portion of Figure 1 ;

Figures 6a and 6b are schematic representations of the sole portion of the embodiment;

Figures 7a and 7b are schematic representations of a cross section of a foot along a heel-toe axis, demonstrating the positioning of components of the embodiment;

Figure 8 shows a schematic representation of an upper portion of an embodiment, including articulated panels;

Figure 9 shows a boot of an embodiment;

Figure 10 shows a perspective view of a boot of an alternative embodiment; Figure 11 shows a schematic view of flexion joints that may be used with the boot of the embodiment shown in Figure 10;

Figure 12a shows a side view of the boot of the embodiment shown in Figure 10 with an air channel;

Figure 12b shows a schematic view of the boot shown in Figure 12a, illustrating the stiffening layer in the upper; Figure 12c shows the boot shown in Figure 12a with a covered tube connected to the air channel;

Figure 13 shows an exploded view of the upper of a boot; Figure 14a shows a side view of a boot with a cut-away rocker sole portion; and

Figure 14b shows an underneath view of the boot of Figure 14a.

Any measurements and/or angles labelled in the Figures are provided for illustrative purposes only, and are not to be taken as limiting. The skilled person would understand that dimensions to be used vary dependent on the foot size and shape of the user, the style of boot chosen, the injury to be accommodated, the amount of padding and or bandaging used, and the like . A boot sole portion 500 of an orthotic boot 1 is provided having what is commonly referred to as a rocker base 500; the boot sole portion 500 also referred to as a "rocker sole". The rocker sole 500 comprises a base formation 3 and a sole body portion 5. In the embodiment being described, the base formation 3 and the sole body portion 5 are provided as separate pieces and joined together such as via an adhesive, welding, or the like. In other embodiments, the base formation 3 and the sole body portion 5 are provided as a single piece, such as a single piece moulding.

The rocker sole 500 is designed to allow a wearer to tilt forwards and backwards more easily, while still maintaining weight on the foot, so reducing load on a wearer' s joints. Rocker soles have a curvature along their length which allows tilting to occur; this curvature can most readily be seen in Figure 2, Figures 5 to 7 and Figure 14.

In the embodiment being described, the curvature of the rocker sole 500 is such that it is widest under the ball of the foot, is narrower under the heel, and tapers towards the toes. This is illustrated most clearly in Figure 7b. In this embodiment, the rocker angle, marked Angle R, of the rocker sole 500 is 20°. In other embodiments, the rocker angle is between 5° and 45°, preferably between 10° and 30°, and more preferably between 15° and 25° .

The apex angle of the boot of the embodiment being described, marked Angle A in Figure 7a, is 80°. In other embodiments, the apex angle is between 70° and 90°, preferably between 75° and 90°, and more preferably between 75° and 85°. The apex of a curve, as marked in Figures 7a, 7b and 14, is the highest point on a curve - in use in a rocker sole, the apex 1403 is the lowest point on the curved sole . The apex 1403 is the position on the curve with the greatest distance between the curve and a straight line between the heel and toe.

The sole portion 500 is substantially rigid. In the embodiment being described, at least one carbon fibre shank 16 is incorporated into the sole portion 500, as shown in Figure 1. Advantageously, the use of at least one carbon fibre shank allows increased rigidity without substantially increasing the thickness of the sole portion 500. The skilled person will understand that shanks of other materials may be used instead of, or as well as, carbon fibre, such as a plastics material, a metal, etc. Further, in some embodiments the shank 16 may extend to have a width corresponding to substantially the whole, upper surface of the sole portion 500.

In the embodiment being described, the sole portion 500 is made of thermoplastic polyurethane (TPU). The skilled man will appreciate that other materials may be used. Advantageously, the material chosen for the sole portion is amenable to injection moulding.

The base formation 3 comprises the grip or tread of the boot. On top of the base formation 3 is a body 5 of the sole portion 500 which defines the perimeter sole portion side wall 7. The sole portion side wall 7 is shaped so as to provide support to the foot of a wearer.

In a top region of the body portion of the sole 5 is a cavity 9 which has a bottom wall 1 1 and a side wall 13. In the embodiment of Figures 1 to 4 the cavity 9 is provided over substantially the whole top surface of the sole body portion 5.

In other embodiments the cavity 9 may be of any suitable size and shape as required. For example the cavity may be provided in a ball of the foot region 14 or may be positioned over substantially the heel region.

In use there is positioned in the cavity 9 a bladder 15. For ease of reference the bladder is shown separately with tracking lines to show positioning relative to the sole portion 500. The bladder 15 rests on the bottom wall 1 1 of the cavity 9 and may be secured by a suitable adhesive such as a glue, or any other suitable securing means, such as hook and eye fasteners, double sided tape, etc.. Indeed, in other embodiments, the bladder 15 may be retained in position by engagement with the side walls 13 of the sole portion 500; i.e. by frictional engagement. In the embodiment being described, the bladder 15 forms part of an insole portion 100. The insole portion 100 further comprises a layer of material covering the area of the sole body portion 5 over which the bladder 15 does not extend. The material is chosen to have a thickness which is small compared to the thickness of the sole, so as not to significantly decrease the space available inside the boot. If the cavity 9 is larger than the bladder 15, the thickness of the material in the region of the cavity 9 not filled by the bladder 15 is chosen to provide a smooth sole with no noticeable discontinuity at the edge of the bladder. In alternative embodiments, the bladder 15 may form substantially all of the insole portion 100, or the insole portion 100 may further comprise lining and/or padding materials such as foams. In the embodiment being described, space is provided within the boot 1 for fitting of a separable insole portion 100. This allows insole portions 100 to be added or replaced. In the embodiment being described, a 2 cm depth of insole allowance 600 is provided for the insole portion 100, tapering towards the toe. In alternative embodiments, the insole depth provided for 600 may be substantially any of the following: 1 cm, 1.5 cm, 2.5 cm, 3 cm, 3.5 cm . In extreme cases, the insole depth may be up to 5 or 7 cm. In some embodiments, the thickness of the insole allowance 600 may not taper towards the toe.

In the embodiment being described, the insole allowance 600 is of substantially equal depth across substantially all of the foot, except where it tapers in the toe region and under the medial arch area of the midfoot. The midfoot refers to the bones and joints that make up the arch of the foot. The midfoot connects the forefoot (comprising the bones of the toes) to the hindfoot (comprising the ankle and heel bones). In the embodiment being described, the rocker 500 has a depth of 17mm (beyond the 20mm insole allowance) at its apex 1403, tapering towards the toe. In alternative embodiments, the rocker 500 depth may be substantially any of the following: 1 cm, 1.5 cm, 2.5 cm, 3 cm, 3.5 cm, and/or may not taper towards the toe. The combined thickness 701 of the rocker 500 and the insole allowance 600 is therefore 37mm at the apex 1403. The distance 702 between the apex 1403 and the toe is 13 1mm in this embodiment. The embodiment shown is a size 10 shoe - the apex to toe distance 702 would vary with shoe size .

Toe spring 703 is the elevation of the toe portion of a shoe or boot above the ground.

A heel layer 700 is provided underneath the rocker sole 500 in the embodiment shown in Figures 7a and 7b. The total heel height 704 (also known as "pitch" or "shoe drop") is 52mm in the embodiment shown. In alternative embodiments, the insole allowance 600 is of substantially equal depth across all of the foot, or is of variable depth to accommodate specific needs of a wearer.

The insole depth 600 is accommodated and disguised by the design of the boot 1 . This is achieved by recessing the insole portion 100 into the sole portion 500 by use of cavity 9 and by the dimension and arrangement of the upper 25. In the embodiment being described, the upper 25 overlaps the sole portion 500, as described in more detail below. A valve 17 is provided on the bladder 15 which allows air in and out of the bladder 15. The valve 17 is fitted to the side of the bladder 15 to be used on the medial side of the boot sole portion 500. In alternative embodiments, such as that shown in Figure 12c, the valve 1217 is connected to the bladder 15 via a tube instead of being connected directly to the bladder. Advantageously, such embodiments may facilitate access to the valve for a user.

A channel 19 is formed through a heel region 21 of the body 5 on the medial side of the sole portion 500. The skilled person would understand that, in other embodiments, the channel leading from the inside to the outside of the boot may be located elsewhere. To accommodate the channel 19 a dip is formed in the bottom wall 1 1 ; in other embodiments this may not be necessary.

The channel 19 extends from the cavity side wall 13 to the sole portion side wall 7 and as such allows communication between the cavity 9 and the outside of the boot 1. The channel 19 is designed to receive an outer part of the valve 17 which protrudes far enough through the channel 19 to be operated by a wearer, or someone else, from the outside of the boot 1. Referring to Figure 2 the rocker sole 500 can be clearly seen. The rocker sole comprises a curvature in the base formation 3 and sole body portion 5 along the length of the sole portion 500. This curvature facilitates easier walking in a heel to toe manner. In the case where the wearer has an injury the rocker sole 500 may reduce stress on the bones, joints and soft tissues of the foot and ankle in question by automatically tilting the foot with the momentum of walking as weight is transferred over it.

Referring to Figure 3, a plurality of semi-rigid pellets 23 are provided inside the bladder 15, which substantially fill the bladder 15. For ease of reference the pellets 23 are shown larger than might be used. The skilled person would understand that fully rigid or soft pellets could also be used.

The pellets 23 comprise a nitrile material, but any other suitable material may be used. In this embodiment the pellets 23 are substantially spherical and are of approximately 3mm in diameter. The skilled person would understand that other sizes and shapes of pellets could be used, for example substantially cubic or rhombic pellets, or the like . The bladder 15 is shaped to fit the cavity 9, but may also be shaped with particular orthopaedic objectives in mind. The outer surface of the bladder 15 comprises a non-porous material, in this case PVC, although many other suitable materials may be used.

The bladder 15 itself is substantially air-tight with passage for air in or out of the bladder being controlled by the valve 17. When air at substantially atmospheric pressure, or above, is present inside the bladder 15 the pellets are relatively free to move about in response to external forces placed on the bladder 15. When the bladder 15 is substantially evacuated the pellets are substantially retained in position and do not move substantially relative to one another.

The valve 17 is of a suitable design to allow removal of air from the bladder 17 while also allowing injection of air back into the bladder 15 when the valve 17 is open. The valve closes automatically when the pump is not in use. The valve is provided with an outer casing that enables it to function even when the sole portion 500 is weight bearing. Additionally the valve 17 is designed to be relatively discreet. In some embodiments, the valve 17 does not protrude beyond the channel 19 so as to ensure that it is not a trip hazard. In alternative embodiments, the valve 1217 is positioned elsewhere - for example at the top of the rear of the boot - again to reduce or avoid the risk of tripping.

As can be seen in Figure 4, the boot 1 also comprises an upper 25 allowing a wearer to retain the boot on his/her foot. The boot 1 is fabricated from one or more materials so as to provide an upper 25 which is stiff enough to retain a wearer's foot in place. In the embodiment being described, the visible part of the upper 25 is made of leather, and a stiffening layer is provided within the upper 25. The skilled person will understand that many other materials, or combinations of materials, may be used. The upper 25 is rigidly connected to the sole portion 500. The upper 25, in conjunction with the rigid sole portion 500, restricts movement of a wearer's foot and ankle . In the embodiment being described, the foot and the ankle joint are substantially immobilised by the combination of the stiff upper 25 and the rigid sole portion 500. The boot 1 extends over the ankle of a wearer to facilitate the immobilisation of the ankle joint.

Those skilled in the art will readily understand that the term "substantially immobilised" does not mean that the foot and ankle have no freedom of movement. Some small freedom of movement is beneficial during, for example, walking, to avoid significant discomfort and embodiments may allow a controlled amount of movement of the ankle. In some alternative and additional embodiments it has been found that such movement is significantly and surprisingly assisted (and the pain associated with such movement is significantly and surprisingly reduced) by using one or more of the following features, which are described in more detail below:

(a) a functional hinge 1201 - 1202 at the level of the ankle,

(b) an upper section of flexible material in the rear collar of the upper heel of the boot; and/or

(c) a rocker sole with the location of the apex 1403 of the curve of the rocker profile of the sole of the boot being at a position forward from the end of the heel substantially at 58% of the length of the sole .

Each of these three features will now be further explained by reference to the accompanying drawings.

As shown in Figure 13, the upper 25 has four layers 25, 25a, 25b, 25c. The outer layer 25, which is the visible part of the upper in use, is the boot outer material (leather, in the embodiment being described) . The layer 25a adjacent to the outer material is a stiffener 25a, which is used to make the upper 25 stiff ("substantially rigid" and "stiff are used interchangeably herein) .

The layer 25b adjacent to the stiffener 25a is a conformation padding layer, arranged to adapt to the shape of a user's foot and ankle and to provide support. The innermost layer 25c is the boot lining. The functional hinge is illustrated in Figures 12a-c, and also in Figure 1 1 . Instead of completely encircling the ankle, the stiffening layer 25b is cut away at the level of the ankle joint, so as to permit greater movement of the ankle. In particular, embodiments may provide the hinge as follows. Where the upper 25 meets the tongue 903 of the boot, there is an indentation 1201 in the upper (through all four layers 25-25c). The indentation 1201 is approximately oblong in shape, extending from where the upper 25 meets the tongue 903 around towards the back of the boot. The cut away portion 1202 of the stiffening layer 25a is a continuation of the indentation 1201 , extending further towards the back of the boot. In the embodiment shown, the cut away portion 1202 extends to the mid-point of the side of the boot.

The indentation 1201 and cut-away portion 1202 allow the boot to bend at the ankle joint to some extent, so allowing a controlled amount of flexion of the ankle joint. A functional hinge is thereby provided by these two cut-away portions 1201 , 1202, as the ankle is allowed to hinge by the bending of the otherwise substantially rigid boot and provide a controlled amount of movement. Thus, in the embodiment being described, the functional hinge is provided by a substantially horizontal cut-away portion at ankle level extending from where the upper meets the tongue towards the back of the boot, at around the level of the top of the heel, allowing controlled movement of the ankle . This position of the cut-away portion may be thought of as extending from where the upper meets the tongue posteriorly so as to form the functional hinge.

Without such a functional hinge the user experiences pain at the top of the boot.

Figure 12b shows the shape of the stiffening layer 25a of the upper 25 of the embodiment shown in Figures 12a-c.

A hole 19 through the stiffening layer 25a provides a channel through which the bladder can be inflated and deflated. In the embodiment shown in Figures 12a- 12c, a tube 1219 is provided from the hole 19 to the top of the boot. An air valve 1217 is provided at the far end of the tube 1219 from the hole 19. The use of a tube 2019, instead of placing the valve 1217 in the hole 19, may facilitate access and attachment of a pump to the valve.

In the embodiment shown, the tube 1209 is concealed by a section of material affixed (e.g. sewn or glued) to the upper 25. The tube 1209 is arranged to lie along a seam of the boot on the inner side of the boot (i.e. such that the tube 1219 is between the legs of a user, not facing outwards) to reduce its visual impact. In alternative or additional embodiments, the tube 1219 may lie between the stiffening layer 25a and the outer layer 25 of the upper. In alternative embodiments, some or all of the tube 1219 may lie inside the boot instead of on the upper surface.

Figure 1 1 shows an alternative embodiment in which a functional hinge is provided by a flexion joint 1 101 which extends all around the circumference of the boot at the level of the ankle and are represented by the grey shaded lines. In this embodiment, some extension of the ankle may be enabled in addition to flexion. Figure 1 1 shows additional joints 1 101. These flexion joints 1 101 can be thought or as articulated joints between stiff panels, as described in more detail below.

Further the comfort of the wearer and functionality during walking is improved by the addition of an upper section of flexible material 1203 in the rear collar of the boot as illustrated in Figures 1 1 , 12a-c. The collar 1207 of the boot is the top portion of the boot, which surrounds a user's leg or ankle . The flexible upper section 1203 in the rear of the collar 1207 of the boot is made of a flexible material, and more specifically is made of the upper outer 25 material with padding and a lining, but without a stiffener, in the embodiment being described. The skilled person would understand that any suitable material which provides greater give (i.e. yield) than the rest of the material from which the upper collar of the boot is made may be used.

In the embodiments shown in the figures, the flexible upper section 1203 covers around 50% of the boot's circumference at its upper edge, with the lower edge of the flexible upper section 1203 curving downwards from the top circumference of the boot collar towards the back of the boot.

Some embodiments are arranged such that the apex of the rocker sole is located forward from the end of the heel substantially the range between 56% to 60%, and most preferably substantially 58%, of the length of the sole of the shoe. Such embodiments have been found to give greater functionality and/or pain reduction for the wearer. By the use of one or more of the features described above and shown in various embodiments, the foot of the wearer of a boot made in accordance with the inventions herein described can be rendered substantially immobile, thus permitted healing, but at the same time the wearer can walk and move about with less pain. In the embodiments shown in Figures 12a-c and 13, adjustable straps 1204 are provided to tighten the boots. The adjustable straps use Velcro® in the embodiments shown. The skilled person would understand that buckles, buttons and/or a hook and eye fastener could be used in alternative or additional embodiments. Further, laces (as shown in Figure 9) could be used instead of, or as well as, adjustable straps.

In the embodiment shown in Figure 12a-c, the tongue 903 is low opening - i.e. when the adjustable straps 1204 are opened, the tongue 903 can be pulled down to lie over the toe of the boot, providing a wide opening for a user's foot. The upper 25 is arranged to partially conceal the thickness of the sole portion 500. In the embodiments being described, this is achieved by having a step 400 in the sole portion 500, such that the upper region of the sole portion 500 fits within the upper 25. The step 400 is shown in Figure 4a. In alternative embodiments, the sole portion 500 may not be stepped. In some of these alternative embodiments, the upper 25 may overlap the sole portion 500 as shown in Figure 4b. Extra width is required in the upper 25 when there is no step 400 in the sole portion 500. In further alternative embodiments, the sole portion 500 may be split such that the base formation 3, providing the rocker, is separated from the sole body portion 5, in which the bladder 15 is mounted. In such embodiments, the upper 25 may overlap the body portion 5 of the sole 500 and fit in between the body portion 5 of the sole portion 500 and the base formation 3 of the sole portion 500, as shown in Figure 4c. The width of the body portion 5 of the sole portion 500 is therefore hidden in such embodiments.

In the embodiments shown in Figures 4a-4e, the side walls 7 on the inner side of the sole form a recess 401 in which the bladder 15 is contained. In the embodiments shown in Figured 4d and 4e, the upper 25 extends over the part of the sole with the recess, so disguising a portion of the sole's depth, and a welt 403 covers some or all of the part of the upper 25 extending over the recess 401. A welt 403 is a strip of leather, rubber, or plastic that runs along the perimeter of a shoe outsole.

In the embodiment of Figure 4d, a normal height welt 403a is used, covering only less than half of the part of the upper 25 extending over the recess 401.

In the embodiment of Figure 4e, an extra height welt 403b is used, covering the majority of the part of the upper 25 extending over the recess 401. In additional or alternative embodiments, all of the part of the upper 25 extending over the recess 401 may be hidden.

In alternative or additional embodiments, a standard welt 403a may be used with an additional filler strip to hide more of the depth of the upper 25 in place of an extra height welt 403b. Figures 4d and 4e show examples of the use of Veldtshoen construction, in which the upper 25 bends outwards where it meets the sole 500 and is connected to the sole 500 there.

An outer region 27 of the bladder is in contact with the sole portion 500 and (when the boot is worn) the wearer's foot.

In use, the valve 17 is opened such that the air inside the bladder 15 is at approximately atmospheric pressure or above . A wearer places his or her foot inside the boot and puts his or her weight on that foot and therefore the bladder 15. As the air in the bladder 15 is at approximately atmospheric pressure the pellets 23 are substantially free to move about within the bladder 15 and therefore form to the shape of the underside of a wearer's foot.

The user then uses a pump (not shown) to substantially evacuate the bladder 15 thereby substantially retaining the pellets 23 in position such that they do not move relative to one another. Thus, the bladder remains substantially rigid under a wearer' s foot. The pump may be hand-held and may for instance be supplied as part of a kit with a shoe. The pellets 23, which are semi-rigid provide cushioning while also providing substantially rigid support following the contours of a wearer's foot.

The positioning of the valve 17 on the medial side of the heel of the sole portion 500 facilitates operation of the pump (not shown) by a wearer. The skilled person would understand that other positions could also be used. The body 5 of the sole portion 500 also provides additional support around the lower sides of the foot. The rocker sole base 500 promotes ease of ambulation, especially where the foot in question is damaged in any way. Referring to Figure 4, the bladder 15 is shown in its substantially evacuated configuration. It can be seen that the bladder 15 has been shaped before evacuation to follow the contours of a wearer's foot (not shown). Additionally the boot upper 25 can be seen. The boot 1 of the embodiment being described further comprises a heel 700. In the embodiment being described, the heel 700 height ranges from 32-37mm and the depth under the rocker sole 500 in the forefoot region ranges from 15- 17mm (incorporating a heel pitch of 17-20mm) . The heel 700 incorporates a striker heel modification 18 to allow transition at heel strike . As shown in Figure 2, the striker heel modification 18 introduces a curve or slant at the back of the heel 700. Advantageously, the striker heel modification 18 facilitates a more comfortable gait for a user. As shown in Figure 9, the upper 25 of the embodiment being described has one or more seams 900. In this embodiment, panels 902 constituting the upper 25 can move relative to each other in the direction transverse to the longitudinal direction of the seam 900 substantially within the plane of the upper 25, indicated for example by arrow B . This movement of the seams may be thought of as lateral movement of the panels. It will be understood by the skilled person that the direction of motion of the panels 902 may not be exactly perpendicular to the seam 900. The panels 902 can therefore be described as being articulated. Advantageously, the relative movement of the panels 902 accommodates swelling and inflammation of the foot. This flexibility of the upper 25 is provided by an elastic material 802 within the upper 25, which connects the panels 902. The elastic material 802 may be coloured to match the colour of the upper 25, or may be a contrasting colour, or matched to the colour of thread used for the seams 900. An elasticated fabric is used in the embodiment being described. In alternative or additional embodiments, neoprene or another resilient, stretchable material is used. The material 802 is deformable when pressure is applied and substantially returns to its initial size and shape when the pressure is removed.

The skilled person would understand that the elastic material 802 permits some relative rotational movement of the panels 902.

In the embodiment being described, the panels 902 overlap such that, where they join, one is closer to a foot of a wearer than the other. The elastic material 802 connecting the panels is between the panels 902 and is arranged in strips where the panels 902 join. The elastic material 902 is therefore connected to the outer surface of the panel closer to a foot of a user and to the inner surface of the outer panel. Advantageously, the elastic material 802 is therefore not visible from the outside of the boot 1. In some embodiments, the panels overlap by more than the width of the elastic material 802. The extra overlap distance x ensures that the elastic material 802 does not become visible when the panel moves apart, or reduces the visibility thereof if x is insufficiently large to account for the displacement.

In alternative embodiments, the elastic material 802 is connected to the inner surface of both panels 902. In these embodiments, the panels 902 are substantially equidistant from a foot of a user at the connecting point. The elastic material 802 may be present in strips along the seams 900 between panels 902, as indicated schematically in Figure 8 by 820. In alternative embodiments, the elastic material 802 covers the entire inner surface of the upper 25. The panels 902 are connected to the elastic material 802, as indicated schematically in Figure 8 by 810.

In the embodiment being described, the panels 902 of the upper 25 can move apart by up to 5mm. In other embodiments, the elastic material 802 allows the panels to move apart by substantially any of the following distances: 2 mm, 5 mm, 8 mm, 10 mm, 15 mm.

Within the rigid upper 25, in the embodiment being described, lining material (not shown) is provided to further support the foot and accommodate foot swelling. In this embodiment, Tempur (RTM) foam is used for the lining material. In additional or alternative embodiments, the lining material is made of a different type of foam or other deformable material.

In the embodiment being described, the lining material is applied in separate panels (not shown) to panels 902 of the outer 25. Articulated movement between the lining panels is permitted by the use of elastic material connecting the lining panels. In alternative embodiments, the lining material is connected directly to the underside of the panels 902, or is provided as a single, flexible piece .

To accommodate the lining material and the overlap with the sole portion 500, an over-sized upper 25 is used as compared to the size of the sole portion 500. For example, if the sole portion 500 corresponds to a size 10 boot, the upper 25 may correspond to a size 1 1 boot. Alternatively, an extra-wide size 10 upper 25 may be used with a sole portion 500 corresponding to a size 10 boot of normal width. In Figure 8, a size 10 standard sole portion 801 is shown with a size 10-wide upper 803.

In the embodiment being described, the upper 25 is fastened by means of laces 904. In alternative or additional embodiments, other fastening means such as a hook and eye type fastener (see the adjustable straps shown in Figures 10 to 13), buckles, zips and/or buttons may be used.

In the embodiment being described, the tongue 903 is low-opening, i.e. it is sufficiently flexible and/or articulated to allow the tongue 903 to be folded forward so as to provide a large entry area into the boot 1 for the foot of a wearer. In alternative or additional embodiments, the boot 1 may be rear opening. The skilled man will appreciate that rear entry to the boot 1 for a foot may be provided by a substantially vertical slit on a heel portion of the boot. The slit may be fastened and unfastened with a zip, buttons, laces, Velcro (RTM) or any other fastening means known to one skilled in the art.

The embodiments herein described look like normal footwear rather than orthotic footwear previously known. They do not look like rigid plastic or similar rehabilitation products, which helps to ensure patient compliance with use requirements after surgery.

In the embodiment being described, such normal looking appearance is achieved by a portion of the sole 500 being recessed in the upper 25 to disguise its thickness, as described above, and, in alternative or additional embodiments, by one or both of the following features:

1) The appearance of the thickness/depth of the upper being reduced by placing extra-long wings 1002 on the vamp section 1001 of the upper 25 ;

2) The deliberate removal of some of the medial and lateral material from the "heel" section of the rocker sole 500 (resulting in a central rib 1502 where the heel meets the rest of the sole), which allows the sole to be a true rocker sole 500 whilst maintaining the appearance of a normal sole with a discreet heel.

The vamp 1001 is the section of upper 25 that covers the front of a user' s foot as far as the back as the join to the quarter 1003 (the section of the upper which wraps around the heel) . In the embodiments shown in Figures 10 to 13, the vamp 1001 has wings 1002 which are longer than those generally used for vamps 1001 , such that the wings 1002 overlap the quarter. In this way, the depth of the upper 25 is broken up, so giving the boot a shallower appearance .

Figures 14a and 14b illustrate the removal of one or more sections of material from the rocker sole 500. These removed sections may be termed cut-away portions 1401 and such embodiments help to allow the boot to have a normal profile, with a discreet heel 700. The removed sections 1401 created a central rib 1402, which maintains the function of the rocker sole 500. In this way, the rocker sole functionality is maintained without detracting from the "normal" appearance of the boot.

Figure 10 illustrates stitching used along seams 1004 of the boot. Relatively wide and/or decorative seams are used to disguise the thickness of the boot. In alternative or additional embodiments, these seams may also be the articulated joins between stiff panels as described above.

The construction of the leather outer 25 mimics that of normal shoe-wear. Further, the boots according to embodiments of the invention would generally be supplied as a pair to facilitate even walking and also to provide a more normal appearance in use . The skilled person would understand that the features discussed above with respect to the embodiments shown in the drawings can be used in isolation or in any suitable combination, to meet the needs of a patient.




 
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