Ankle-foot orthosis

Abstract

The invention relates to an ankle-foot orthosis (AFO), comprising: (i) a footrest including a non-trimmable portion and at least one trimmable portion; (ii) a calf support element including a non-trimmable portion and at least two trimmable portions, the at least two trimmable portions being located in an area at least adjacent to the upper edge of the calf support element and the lower edge of the calf support element; and (iii) a spacer extending between the footrest and the calf support element. Figure for the abstract: Fig. 1

Description

Title of the invention: Ankle-foot orthosis

[0001] The present invention relates to orthotic devices. In particular, the present invention relates to an ankle-foot orthosis (AFO) itself, and methods for fitting an AFO to a patient.

[0002] The use of highly resistant and lightweight materials in the manufacture of orthoses can have clinical advantages. For example, in lower limb studies, lightweight ankle-foot orthoses (AFOs) have been shown to decrease energy expenditure during walking and can increase a patient's cadence. An AFO consists of a lower footrest that supports the patient's foot, an elongated strut that extends upward and around the patient's ankle, and a cuff by which the AFO is attached to the patient's calf. Composite fiber materials have been found to be effective in providing an orthotic force model, that is, the application of force to pressure-tolerant areas of the anatomy of a person using an orthosis to force a biomechanical change, while simultaneously being lightweight and strong.

[0003] When fitting a prefabricated AFO to a patient, a specialist physician or orthotist typically needs to trim areas of the AFO, particularly around the peripheral edge of the footrest, because a specific size of prefabricated AFO is required to fit a range of different foot / shoe sizes. However, trimming composite fiber materials is difficult and requires a specialized cutting and sanding machine. For some orthotists who travel from hospital to hospital or workplace to workplace, the only tool likely available is household scissors, which are not capable of trimming many types of composite orthoses. For this reason, an orthotist who does not have access to appropriate trimming tools / machines may need to use AFOs containing plastic materials, such as polypropylene or polyethylene, instead of composite fibers.These AFOs can be easily trimmed with scissors, allowing the practitioner to adjust the AFO for a given user. However, a plastic AFO may not be as light and / or as strong as a composite fiber AFO, and may therefore provide the user with a lesser medical outcome than that obtained when a composite fiber AFO is used.

[0004] The present invention is the result of the work of the inventors who attempted to overcome the problems associated with the prior art.

[0005] Therefore, in a first aspect of the invention, an ankle-foot orthosis (AFO) is provided, comprising:

[0006] (i) a footrest comprising a non-cuttable part and at least one part trimmable;

[0007] (ii) a calf stop element comprising a non-trimmable portion and at least two trimmable portions, the at least two trimmable portions being located in an area at least adjacent to the upper edge of the calf stop element and to the lower edge of the calf stop element; and

[0008] (iii) a spacer extending between the footrest and the calf stop element.

[0009] Advantageously, the claimed AFO can be cut on the upper and lower sides of the calf cuff, allowing the AFO to be customized to fit a wide range of leg shapes. For example, the height of the brace can be adjusted by cutting a portion at the upper edge if the patient has shorter legs. Alternatively, the height of the brace can also be adjusted by cutting a portion at the lower edge if the patient has longer legs. Furthermore, the claimed product can be cut using simple office scissors. This is due to the fibers used, as the fineness of the fibers and the material used allow for "cuttingability."

[0010] In one embodiment, the footrest is designed to extend under the sole of a subject's foot. Typically, the footrest comprises a front that extends under the subject's toes, a rear that extends under the subject's heel, and two sides that extend between the front and the rear.

[0011] In one embodiment, at least one trimmable portion of the footrest is located in a rear foot region of the footrest. In another embodiment, at least one trimmable portion of the footrest is located in a forefoot region of the footrest. In some embodiments, the footrest comprises at least two trimmable portions. Therefore, the at least two trimmable portions of the footrest can be located in a rear foot region and a forefoot region of the footrest.

[0012] In some embodiments, at least one area adjacent to and / or towards the front of the footrest includes at least one trimmable portion. Consequently, the at least one trimmable portion typically defines an extension of the footrest's length.

[0013] In certain embodiments, at least one trimmable part extends around the peripheral edge of the footrest at least adjacent to the position of the subject's toes when the orthosis is worn by a subject.

[0014] The trimmable part towards the front of the footrest can increase the length of the footrest by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, by at least 2.0 cm or 2.5 cm at its longest point, or by at least 3.0 cm at its longest point.

[0015] The trimmable part towards the front of the footrest can increase the length of the footrest from 0.5 cm to 10.0 cm at its longest point, from 1.0 cm to 7.5 cm or from 1.5 cm to 5.0 cm at its longest point, or from 2.0 cm to 4.0 cm or from 2.5 cm to 3.5 cm at its longest point.

[0016] Alternatively or furthermore, at least one area adjacent to and / or extending towards a region on one or both sides of the footrest includes at least one trimmable portion. Typically, the area at least adjacent to and / or extending towards a region on one or both sides of the footrest is also at least adjacent to and / or extending forward from the footrest. Therefore, the at least one trimmable portion preferably defines an extension of the width on at least one side of the footrest.

[0017] The part that can be cut along the width of the footrest can increase the width of the footrest by at least 0.25 cm at its widest point, by at least 0.5 cm or 1.0 cm at its widest point, or by at least 1.5 cm at its widest point.

[0018] The part that can be cut along the width of the footrest can increase the width of the footrest between 0.25 cm and 10.0 cm at its widest point, between 0.5 cm and 7.5 cm or between 1.0 cm and 5.0 cm at its widest point, or between 1.5 cm and 2.5 cm at its widest point.

[0019] In some embodiments, the at least one trimmable part defines an extension on both sides of the footrest.

[0020] Therefore, the part that can be cut along the width of the footrest can increase the width of the footrest by at least 0.125 cm on each side at its widest point, by at least 0.25 cm or 0.5 cm on each side at its widest point, or by at least 0.75 cm on each side at its widest point.

[0021] The part that can be cut along the width of the footrest can increase the width of the footrest between 0.125 cm and 5.0 cm on each side at its widest point, between 0.25 cm and 3.75 cm or between 0.5 cm and 2.5 cm on each side at its widest point, or between 0.75 cm and 1.25 cm on each side at its widest point.

[0022] In some embodiments, at least one area adjacent to and / or towards the rear of the footrest includes at least one trimmable portion. Therefore, in some embodiments, at least one trimmable portion extends around the peripheral edge of the footrest at least adjacent to the position of the subject's heel when the orthosis is worn by a subject. Typically, however, a portion towards the rear of the footrest is made of a non-trimable material, such that it can be connected to the spacer.

[0023] Consequently, at least one trimmable part can extend around the peripheral edge of the footrest at least adjacent to the position of the subject's heel when the orthosis is worn by a subject.

[0024] The part that can be cut towards the rear of the footrest can increase the length of the footrest by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, by at least 2.0 cm or 2.5 cm at its longest point, or by at least 3.0 cm at its longest point.

[0025] The part that can be cut towards the rear of the footrest can increase the length of the footrest between 0.5 cm and 10.0 cm at its longest point, between 1.0 cm and 7.5 cm or between 1.5 cm and 5.0 cm at its longest point, or between 2.0 cm and 4.0 cm or between 2.5 cm and 3.5 cm at its longest point.

[0026] The footrest may comprise at least two cuttable parts. Therefore, in some embodiments, an area adjacent to the front of the footrest and an area adjacent to a part on both sides of the footrest comprise the cuttable part.

[0027] The footrest may comprise at least three or four trimmable parts. Therefore, in some embodiments, an area adjacent to the front of the footrest, an area adjacent to the rear of the footrest, and an area adjacent to a part on both sides of the footrest comprise the trimmable part.

[0028] Advantageously, this allows the front, sides and back of the footrest to be shaped so that the orthosis can be designed to fit a range of different shoe sizes.

[0029] In some embodiments, at least one cuttable portion extends around the entire peripheral edge of the footrest. Typically, however, a portion towards the rear of the footrest is made of a non-cuttable material, so that it can be connected to the spacer.

[0030] In addition, the low Young's modulus of the trimmable part is advantageous because of the large amplitude of flexural movement that occurs in this area during walking.

[0031] In certain embodiments where the plurality of non-cuttable fibers includes unidirectional fibers, the unidirectional fibers are arranged in the footrest and aligned substantially parallel to the long axis of the foot of a subject. It can be understood that the long axis of the foot is a theoretical straight line from the middle of the heel through the second toe of the subject. Advantageously, the unidirectional fibers reinforce the footrest along the long axis.

[0032] It will be borne in mind that the calf stop element is intended to butt against the calf of a subject.

[0033] The calf stop element comprises at least two trimmable parts located in an area at least adjacent to the upper and lower edges of the element of the calf support. In other words, one of the at least two trimmable sections extends around an upper edge of the calf support element, and one of the at least two trimmable sections extends around a lower edge of the calf support element. Therefore, the height of the brace can be adjusted by trimming a section at the upper edge if the patient has shorter legs. Alternatively, the height of the brace can also be adjusted by trimming a section at the lower edge if the patient has longer legs.

[0034] The calf support element may comprise at least three or four cuttable portions. In some embodiments, the calf support element includes a cuttable portion located in an area at least adjacent to the upper edge, the lower edge, and both lateral edges of the calf support element. It should therefore be borne in mind that the calf support element can be cut around its entire edge (except where the spacer is located). Consequently, in some embodiments, the at least two cuttable portions extend around the entire peripheral edge of the calf support element. Typically, however, a portion located in the center of the calf support element is made of a non-cuttable material, such that it can be connected to the spacer.

[0035] It should be borne in mind that at least one area adjacent to the upper edge of the calf support element is the area located at the highest point of the calf support element that rests on the patient's knee. At least one area adjacent to the lower edge of the calf support element is the area located at the lowest point of the calf support element when worn by the patient.

[0036] In one embodiment, the calf stop element is designed to extend around the back of the subject's leg.

[0037] In another embodiment, the calf stop element is designed to extend around the front of the subject's leg. In other words, the calf stop element extends around the subject's tibia. In this embodiment, the calf stop element may be a tibia shell (or an anterior shell).

[0038] In certain embodiments, the non-cuttable portion of the calf stop element is located between the at least two cuttable portions at the upper and lower edges of the calf stop element. In other words, the non-cuttable portion of the calf stop element is located in the middle of the calf stop element, between the two cuttable portions at the upper and lower edges of the calf stop element.

[0039] Furthermore, in certain embodiments, a portion near the lower edge of the calf stop element is made of a non-machinable material, such that it can be connected to the spacer. Typically, this non-machinable portion is located in the center of the calf stop element.

[0040] The trimmable portion at the upper edge can increase the height of the calf stop element by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, or by at least 2.0 cm or 2.5 cm at its longest point. Alternatively, the trimmable portion at the upper edge can increase the height of the calf stop element by at least 2.0 or 2.5 cm at its longest point, by at least 3.0 or 3.5 cm at its longest point, by at least 4.0 or 4.5 cm at its longest point, or by at least 5.0 cm at its longest point.

[0041] The trimmable part at the upper edge can increase the height of the calf stop element between 0.5 cm and 10.0 cm at its longest point, between 1.0 cm and 7.5 cm or between 1.5 cm and 5.0 cm at its longest point, or between 2.0 cm and 4.0 cm or between 2.5 cm and 3.5 cm at its longest point.

[0042] The trimmable portion at the lower edge can increase the height of the calf stop element by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, or by at least 2.0 cm or 2.5 cm at its longest point. Alternatively, the trimmable portion at the lower edge can increase the height of the calf stop element by at least 2.0 or 2.5 cm at its longest point, by at least 3.0 or 3.5 cm at its longest point, by at least 4.0 or 4.5 cm at its longest point, or by at least 5.0 cm at its longest point.

[0043] The trimmable part at the lower edge can increase the height of the calf stop element between 0.5 cm and 10.0 cm at its longest point, between 1.0 cm and 7.5 cm or between 1.5 cm and 5.0 cm at its longest point, or between 2.0 cm and 4.0 cm or between 2.5 cm and 3.5 cm at its longest point.

[0044] Therefore, the trimmable portion at the upper and lower edges can increase the height of the calf stop element by at least 1.0 cm at its longest point, by at least 1.5 cm or 2.0 cm at its longest point, or by at least 2.5 cm or 3.0 cm at its longest point. Alternatively, the trimmable portion at the upper and lower edges can increase the height of the calf stop element by at least 3.5 cm at its longest point, by at least 4.0 or 4.5 cm at its longest point, by at least 5.0 or 5.5 cm at its longest point, or by at least 6.0 or 6.5 cm at its longest point.Alternatively, the trimmable portion at the top and bottom edges can increase the height of the calf stop element by at least 7.0 or 7.5 cm at its longest point, at least 8.0 or 8.5 cm at its longest point, at least 9.0 or 9.5 cm at its longest point, or at least 10.0 cm at its longest point.

[0045] The trimmable portion at the upper and lower edges can increase the height of the calf stop element by between 1.0 cm and 20.0 cm at its longest point, between 1.0 cm and 15.0 cm, or between 1.0 cm and 10.0 cm. Alternatively, the trimmable portions at the upper and lower edges can increase the height of the calf stop element by between 5.0 cm and 20.0 cm at its longest point, or between 10.0 cm and 20.0 cm, or between 15.0 cm and 20.0 cm at its longest point.

[0046] The trimmable portion at the two lateral edges can increase the width of the calf stop element by at least 0.5 cm at its widest point, by at least 1.0 cm or 1.5 cm at its widest point, or by at least 2.0 cm or 2.5 cm at its widest point. Alternatively, the trimmable portion at the two lateral edges can increase the width of the calf stop element by at least 2.0 or 2.5 cm at its widest point, by at least 3.0 or 3.5 cm at its widest point, by at least 4.0 or 4.5 cm at its widest point, or by at least 5.0 cm at its widest point.

[0047] The part that can be cut at the two lateral edges can increase the width of the calf stop element between 0.5 cm and 10.0 cm at its widest point, between 1.0 cm and 7.5 cm or between 1.5 cm and 5.0 cm at its widest point, or between 2.0 cm and 4.0 cm or between 2.5 cm and 3.5 cm at its widest point.

[0048] In one embodiment, the orthosis includes a removable fastener for attaching the calf support element to a subject's leg. The removable fastener may include a strap for connecting the opposite ends of the calf support element. Thus, the calf support element and the strap can be designed to encircle the subject's calf, and tightening the strap can secure the orthosis. The strap can be held in position by means of a Velcro fastener or a hook fastener.

[0049] The spacer extends between the footrest and the calf stop element.

[0050] In one embodiment, the spacer is connected to the footrest at a location designed to be posterior (i.e., behind) to the ankle axis of a subject wearing the orthosis. In another embodiment, the spacer is connected to the calf support element at a location designed to be posterior (i.e., behind) to the knee of a subject wearing the orthosis.

[0051] In another embodiment, the spacer is connected to the footrest at a location designed to be along one of the two sides of the footrest. In some embodiments, the spacer is connected to the footrest at a location designed to be along the outer side of the footrest (i.e., when worn by the patient, the outer side of the footrest- foot is the side that would be furthest from the patient's other foot). In one embodiment, the spacer is connected to the calf stop element at a location that is designed to be anterior (i.e., in front) of the knee of a subject wearing the orthosis.

[0052] In one embodiment, the spacer is connected to the non-cuttable part of the footrest and to the non-cuttable part of the calf stop element.

[0053] In one embodiment, the spacer is designed to extend over the back of the subject's leg. In another embodiment, the spacer is designed to extend over the front of the subject's leg. In yet another embodiment, the spacer is designed to extend over the side and / or front of the subject's leg.

[0054] In some embodiments, the spacer comprises or is made of a non-machinable material. Therefore, in some embodiments, the spacer comprises or is made of carbon fibers. In some embodiments, the spacer is made of fiberglass, polyester, or some other technical fiber.

[0055] Advantageously, the trimmable portions of the footrest and calf sleeve are visually distinct from the non-trimable portion due to the presence of guide lines or grooves. It should be borne in mind that the guide lines or grooves (also called indentations or trim lines) allow the footrest and / or calf sleeve to be trimmed and shaped. The guide lines or grooves may be gray or black.

[0056] Therefore, in one embodiment, at least one of the cuttable portions of the footrest includes guide lines or grooves. In another embodiment, at least two of the cuttable portions of the calf support element include guide lines or grooves. In some embodiments, the cuttable portions of both the footrest and the calf support element include guide lines or grooves.

[0057] In some embodiments, the guide lines / grooves are located around the outer periphery of the footrest. In some embodiments, the guide lines / grooves are located at the periphery around the front, sides, and rear of the footrest. In some cases, the guide lines / grooves are located along the upper and lower edges of the calf support element.

[0058] In some embodiments, the footrest and the calf support element comprise at least one set of guide lines / grooves, at least two sets of guide lines / grooves, or at least three sets of guide lines / grooves. Thus, the footrest and the calf support element can be cut to several different sizes.

[0059] In one embodiment, the trimmable portion comprises or is made of polyester fibers. In one embodiment, at least one trimmable portion of the footrest comprises or is made of polyester fibers. In one embodiment, at least two trimmable portions of the calf support element comprise or are made of polyester fibers. Advantageously, the trimmable portion can be easily cut with scissors, allowing the orthosis to be adjusted for a specific individual.

[0060] The polyester fibers may be high-tenacity polyester fibers. In some embodiments, the polyester fibers may be polyolefin fibers.

[0061] In one embodiment, the polyester fiber has a weight between 50 and 150 g / m2, between 60 and 140 g / m2, between 70 and 130 g / m2, between 80 and 120 g / m2, or between 90 and 110 g / m2.

[0062] In another embodiment, the polyester fiber has a weight of between 90 and 150 g / m², between 90 and 140 g / m², between 90 and 130 g / m², between 90 and 120 g / m², or between 90 and 110 g / m². In another embodiment, the polyester fiber has a weight of between 50 and 110 g / m², between 60 and 110 g / m², between 70 and 110 g / m², between 80 and 110 g / m², or between 90 and 110 g / m². Typically, the polyester fiber has a weight of 100 g / m².

[0063] In some embodiments, the cuttable portion (i.e., the polyester fibers) comprises a polymer resin. In some embodiments, the polyester fibers are impregnated with a polymer resin.

[0064] In some embodiments, the cuttable portion comprises between 20% and 60%, between 25% and 55%, between 30% and 50%, or between 35% and 45% polymer resin.

[0065] In another embodiment, the machinable portion comprises between 35% and 60%, between 35% and 35%, between 35% and 50%, or between 35% and 45% polymer resin. In another embodiment, the machinable portion comprises between 20% and 45%, between 25% and 45%, between 30% and 45%, or between 35% and 45% polymer resin. Typically, the machinable portion comprises 40% polymer resin.

[0066] The polymer resin can be an epoxy resin.

[0067] In another embodiment, the polymer resin can be acrylic.

[0068] In one embodiment, at least one trimmable portion of the footrest comprises at least one layer of polyester fibers. In another embodiment, the trimmable portion of the footrest comprises at least two layers of polyester fibers. In another embodiment, the trimmable portion of the footrest comprises at least three, four, or five layers of polyester fibers. In yet another embodiment, the trimmable portion of the footrest comprises at least six layers of polyester fibers.

[0069] In some embodiments, the polyester fibers of the footrest have a weight of at least 50 g / m2, at least 75 g / m2, or at least 100 g / m2. In some embodiments, the polyester fibers of the footrest have a weight between 50 g / m2 and 150 g / m2, between 60 g / m2 and 140 g / m2, between 70 g / m2 and 130 g / m2, between 80 g / m2 and 120 g / m2, or between 90 g / m2 and 110 g / m2. In some embodiments, the polyester fibers of the footrest have a weight between 50 g / m2 and 140 g / m2, between 50 g / m2 and 130 g / m2, between 50 g / m2 and 120 g / m2, between 50 g / m2 and 110 g / m2, or between 50 g / m2 and 100 g / m2.

[0070] In some embodiments, the polyester fibers of the footrest have an orientation between 0 and 50°, or between 10 and 50°, or between 20 and 50°, or between 30 and 50°, or between 40 and 50°. In another embodiment, the polyester fibers of the footrest have an orientation between 0 and 40°, between 0 and 30°, between 0 and 20°, or between 0 and 10°. In some cases, the polyester fibers of the footrest have an orientation of 45°, 30°, 15°, or 0°.

[0071] In one embodiment, the at least two trimmable parts of the calf stop element comprise at least one layer of polyester fibers. In another embodiment, the at least two trimmable parts of the calf stop element comprise at least two layers of polyester fibers. In yet another embodiment, the at least two trimmable parts of the calf stop element comprise at least three, four, or five layers of polyester fibers.

[0072] In some embodiments, the polyester fibers of the calf stop element have a weight of at least 50 g / m2, at least 75 g / m2, or at least 100 g / m2. In some embodiments, the polyester fibers of the calf stop element have a weight between 50 g / m2 and 150 g / m2, between 60 g / m2 and 140 g / m2, between 70 g / m2 and 130 g / m2, between 80 g / m2 and 120 g / m2, or between 90 g / m2 and 110 g / m2. In some embodiments, the polyester fibers of the calf stop element have a weight between 50 g / m2 and 140 g / m2, between 50 g / m2 and 130 g / m2, between 50 g / m2 and 120 g / m2, between 50 g / m2 and 110 g / m2, or between 50 g / m2 and 100 g / m2.

[0073] In some embodiments, the polyester fibers of the calf stop element have an orientation between 0 and 50°, or between 10 and 50°, or between 20 and 50°, or between 30 and 50°, or between 40 and 50°. In another embodiment, the polyester fibers of the calf stop element have a fiber orientation between 0 and 40°, between 0 and 30°, between 0 and 20°, or between 0 and 10°. In some embodiments, the polyester fibers of the calf stop element have an orientation of 45°, 30°, 15°, or 0°.

[0074] In one embodiment, the non-cuttable portion comprises or is made of carbon fibers. Advantageously, due to the carbon fiber-reinforced polymer, the non-cuttable portion is strong and lightweight.

[0075] The non-cuttable portion may comprise non-woven fibers. The non-woven fibers may comprise unidirectional fibers. Alternatively, the non-cuttable portion may comprise woven fibers. The woven fibers may comprise bidirectional fibers (e.g., twill fibers, plain weave fibers).

[0076] In one embodiment, the non-cuttable portion comprises both non-woven and woven fibers. In another embodiment, the non-cuttable portion comprises both unidirectional and bidirectional fibers (e.g., twill fibers). In yet another embodiment, the non-cuttable portion comprises both unidirectional and bidirectional carbon fibers. In yet another embodiment, the non-cuttable portion comprises unidirectional carbon fibers interleaved between bidirectional carbon fibers.

[0077] Advantageously, unidirectional fibers reinforce the orthosis along the axis on which they are aligned. In addition, bidirectional fibers (e.g., twill fibers) provide the orthosis with transverse resistance.

[0078] Therefore, in one embodiment, the carbon fibers may comprise bidirectional (e.g., twill) carbon fibers and / or unidirectional (UD) carbon fibers. In one embodiment, the carbon fibers may comprise bidirectional (e.g., twill) carbon fibers and unidirectional (UD) carbon fibers.

[0079] In one embodiment, the bidirectional carbon fiber has a weight of between 100 and 300 g / m2, between 120 and 280 g / m2, or between 140 and 260 g / m2. In another embodiment, the bidirectional carbon fiber has a weight of between 160 and 240 g / m2, or between 180 and 220 g / m2.

[0080] In another embodiment, the bidirectional carbon fiber has a weight of between 180 and 300 g / m², between 180 and 280 g / m², between 180 and 260 g / m², between 180 and 240 g / m², or between 180 and 220 g / m². In another embodiment, the bidirectional carbon fiber has a weight of between 100 and 220 g / m², between 120 and 220 g / m², between 140 and 220 g / m², between 160 and 220 g / m², or between 180 and 220 g / m². Typically, the bidirectional carbon fiber has a weight of 200 g / m².

[0081] In one embodiment, the unidirectional (UD) carbon fiber has a weight between 150 and 1000 g / m2, between 200 and 900 g / m2, or between 300 and 850 g / m2. In another embodiment, the unidirectional (UD) carbon fiber has a weight between 400 and 800 g / m2, between 420 and 780 g / m2, between 440 and 760 g / m2, between 460 and 740 g / m2, or between 480 and 720 g / m2. In another embodiment, the unidirectional (UD) carbon fiber has a weight between 500 and 700 g / m2, between 520 and 680 g / m2, between 540 and 660 g / m2, between 560 and 640 g / m2, or between 580 and 620 g / m2.

[0082] In another embodiment, the unidirectional (UD) carbon fiber has a weight between 580 and 800 g / m2, between 580 and 780 g / m2, between 580 and 760 g / m2, between 580 and 740 g / m2, between 580 and 720 g / m2, or between 580 and 700 g / m2. In another embodiment, the unidirectional (UD) carbon fiber has a weight between 580 and 680 g / m2, between 580 and 660 g / m2, between 580 and 660 g / m2, between 580 and 640 g / m2, or between 580 and 620 g / m2.

[0083] In another embodiment, the unidirectional (UD) carbon fiber has a weight of between 150 and 620 g / m², between 200 and 620 g / m², between 250 and 620 g / m², between 300 and 620 g / m², or between 350 and 620 g / m². In another embodiment, the unidirectional (UD) carbon fiber has a weight of between 400 and 620 g / m², between 420 and 620 g / m², between 440 and 620 g / m², between 460 and 620 g / m², between 480 and 620 g / m², or between 500 and 620 g / m². In another embodiment, the unidirectional (UD) carbon fiber has a weight between 520 and 620 g / m2, between 540 and 620 g / m2, between 560 and 620 g / m2, or between 580 and 620 g / m2. Typically, the unidirectional (UD) carbon fiber has a weight of 600 g / m2.

[0084] In some embodiments, the non-cuttable portion (e.g., the carbon fibers) comprises a polymer resin. In some embodiments, the carbon fibers are impregnated with a polymer resin.

[0085] In some embodiments, the non-cuttable portion comprises between 20% and 60%, between 25% and 55%, between 30% and 50%, or between 35% and 45% polymer resin.

[0086] In another embodiment, the non-cuttable portion comprises between 35% and 60%, between 35% and 35%, between 35% and 50%, or between 35% and 45% polymer resin. In another embodiment, the non-cuttable portion comprises between 20% and 45%, between 25% and 45%, between 30% and 45%, or between 35% and 45% polymer resin. Typically, the non-cuttable portion comprises 40% polymer resin.

[0087] The polymer resin can be an epoxy resin.

[0088] In another embodiment, the polymer resin can be acrylic.

[0089] In one embodiment, the non-cuttable part of the footrest comprises Carbon fibers. In one embodiment, the non-cuttable portion of the footrest comprises bidirectional carbon fibers (e.g., carbon twill). In another embodiment, the non-cuttable portion of the footrest comprises unidirectional carbon fibers (UD carbon). In another embodiment, the non-cuttable portion of the footrest comprises both unidirectional and bidirectional carbon fibers (e.g., carbon twill and UD carbon). In yet another embodiment, the non-cuttable portion of the footrest comprises fiberglass. In yet another embodiment, the non-cuttable portion of the footrest comprises both fiberglass and unidirectional fiberglass.

[0090] In some cases, the carbon fiber or glass fiber (e.g., carbon twill or UD carbon) has a fiber orientation between 0° and 50°, or between 10° and 50°, or between 20° and 50°, or between 30° and 50°, or between 40° and 50°. In another mode In this particular design, the carbon fiber or fiberglass has a fiber orientation between 0 and 40°, between 0 and 30°, between 0 and 20°, or between 0 and 10°. In some embodiments, the carbon fiber or fiberglass has a fiber orientation of 45°, 30°, 15°, or 0°. This non-cuttable section is placed in the middle of the calf band to make it more rigid.

[0091] In one embodiment, the non-cuttable portion of the calf stop element comprises carbon fibers. In one embodiment, the non-cuttable portion of the calf stop element comprises bidirectional carbon fibers (e.g., carbon twill). In one embodiment, the non-cuttable portion of the calf stop element is made of unidirectional carbon. In one embodiment, the non-cuttable portion of the calf stop element comprises bidirectional and unidirectional carbon fibers (e.g., carbon twill and unidirectional carbon). In another embodiment, the non-cuttable portion of the calf stop element comprises a glass fiber. In yet another embodiment, the non-cuttable portion of the calf stop element comprises a glass fiber and a unidirectional glass fiber.

[0092] In some cases, the carbon fiber or glass fiber (e.g., carbon twill or UD carbon) has a fiber orientation between 0° and 50°, or between 10° and 50°, or between 20° and 50°, or between 30° and 50°, or between 40° and 50°. In another embodiment, the carbon fiber or glass fiber has a fiber orientation between 0° and 40°, between 0° and 30°, between 0° and 20°, or between 0° and 10°. In some embodiments, the carbon fiber or glass fiber has an orientation of 45°, 30°, 15°, or 0°. This non-cuttable portion is placed in the middle of the calf band to make it more rigid.

[0093] It will be borne in mind that the AFO according to the first aspect, will be adjusted to and worn by a patient.

[0094] Therefore, a second aspect of the invention provides a method for fitting an ankle-foot orthosis (AFO) to a patient, the method comprising:

[0095] (i) the shaping of a footrest for the AFO to adjust it to the patient, in which the footrest includes a non-cuttable part and at least one cuttable part;

[0096] (ii) the trimming of a calf support element of the AFO to fit it to the patient, wherein the calf support element comprises a non-trimmable portion and at least two trimmable portions, the at least two trimmable portions being located in an area at least adjacent to the upper edge of the calf support element and to the lower edge of the calf support element; and

[0097] (iii) attaching the AFO to the patient with a removable fixation.

[0098] It will be borne in mind that the AFO used in the process according to the second aspect is as described in the first aspect.

[0099] Advantageously, the AFO can be cut on the upper and lower sides of the calf cuff, allowing the AFO to be customized to fit a wide range of leg shapes. For example, the height of the brace can be adjusted by cutting a portion at the upper edge if the patient has shorter legs. Therefore, in one embodiment, the method includes cutting the calf support element along the cuttable portion located in an area at least adjacent to the upper edge of the calf support element.

[0100] Alternatively, the height of the orthosis can also be adjusted by cutting a portion at the lower edge if the patient has longer legs. Therefore, in one embodiment, the method includes cutting the calf support element along the cuttable portion located in an area at least adjacent to the lower edge of the calf support element.

[0101] In one embodiment, the method includes cutting the footrest along the cuttable part.

[0102] All the features described here and / or all the steps of any disclosed method or process can be combined with any of the preceding aspects, except for combinations where at least some of these features and / or steps are mutually exclusive. Brief description of the drawings

[0103] For a better understanding of the invention and to show how embodiments thereof can be implemented, reference will now be made, by way of example, to the accompanying figures, in which

[0104] [Fig. 1] [Fig. 1] illustrates an embodiment of an ankle-foot orthosis (AFO) according to the invention, comprising a trimmable calf support element. The trimmable portions are located on the upper and lower edges of the calf support element.

[0105] [Fig.2] Figure [Fig.2] illustrates an embodiment of AFO according to the invention, including a trimmable footrest. The trimmable parts of the footrest are located towards and around the front of the footrest (i.e., where the user's toes are positioned), and towards the rear of the footrest (i.e., where the user's heel is positioned).

[0106] [Fig. 3] [Fig. 3] illustrates an embodiment of AFO according to the invention. The The trimmable parts of the calf stop element and footrest may include grooves (indentations or sizing lines) to help guide the trimming of the calf stop element and footrest.

[0107] [Fig. 4] Figure 4 illustrates one embodiment of a cuttable footrest. The footrest includes a trimmable section around the front of the footrest (i.e., (i.e., where the user's toes are positioned) and towards the back of the footrest (i.e., where the user's heel is positioned).

[0108] [Fig. 5] [Fig. 5] illustrates one embodiment of a calf stop element The calf stop element includes a non-trimmable part, located between two trimmable parts, at the upper and lower edges of the calf stop element.

[0109] [Fig.6] Fig.6 illustrates another embodiment of a stop element trimmable calf. The calf stop element includes a trimmable portion in an area at least adjacent to the upper edge, the lower edge and the two lateral edges of the calf stop element.

[0110] Examples

[0111] The inventors sought to manufacture an AFO that is adjustable by the fitter (person in charge of choosing and adjusting the product on the patient).

[0112] Composites

[0113] The inventors used different composites for this product: [Tables 1] Fiber Fiber Weight Resin Carbon Twill 100 to 300 g / m2 Epoxy Resin UD Carbon 400 to 800 g / m2 High Tenacity Polyester 50 to 150 g / m2

[0114] Cutability

[0115] The inventors wanted the height of the product and the length of the footrest to be adjustable. To achieve this, the inventors defined an arrangement of different materials to be cut.

[0116] AFO scalable

[0117] Figures 1 and 2 illustrate an embodiment given by way of example of an AFO according to the invention, comprising a footrest 1, a spacer 2 and a calf stop element 3.

[0118] As illustrated in [Fig. 1], the calf support element 3 comprises a non-trimmable portion 4 and at least two trimmable portions 5, 6. The trimmable portions 5, 6 are located on the upper and lower edges of the calf support element 3. The non-trimmable portion 4 is located between the trimmable portions 5, 6. Therefore, the height of the brace can be adjusted by trimming a portion at the upper edge 5 if the patient has shorter legs. Alternatively, the height of the brace can also be adjusted by trimming a portion at the lower edge 6 if the patient has longer legs.

[0119] As illustrated in [Fig.2], the footrest 1 also includes a non-trimmable part 6 and at least one trimmable part 7, 8. The trimmable parts 7, 8 are located in an area adjacent to the front of the footrest 7, an area adjacent to the rear of the footrest 8, and an area adjacent to a part of both sides of the footrest 11.

[0120] Figure 3 illustrates an exemplary embodiment of an AFO according to the invention, wherein the trimmable portions of the footrest 1 and the calf support element 3 comprise grooves (indentations / trimming lines) 9, 10 to help guide the trimming of the calf support element and the footrest. Consequently, the wearer can determine the circumference that fits their feet and trim the footrest accordingly along the grooves to correctly size the AFO.

[0121] As illustrated in [Fig. 4], the AFO footrest includes at least one trimmable portion around the front of the footrest 7 (i.e., where the user's toes are positioned) and towards the rear of the footrest 8 (i.e., where the user's heel is positioned). Furthermore, as illustrated in [Fig. 5], the AFO calf stop element includes a non-trimable portion 4, located between two trimmable portions 5, 6, at the upper and lower edges of the calf stop element. In addition, as illustrated in [Fig.6], the AFO calf stop element may include two trimmable parts 5, 6, at the upper and lower edges of the calf stop element, and two trimmable parts 12, 13, along the two lateral edges of the calf stop element.The trimmable parts of the footrest and calf stop element are typically made of polyester fibers, while the non-trimable parts are typically made of carbon fibers.

Claims

Demands

1. An ankle-foot orthosis (AFO), comprising: (i) a footrest (1) including a non-trimmable portion (6) and at least one trimmable portion (7; 8); (ii) a calf stop element (3) including a non-trimmable portion (4) and at least two trimmable portions (5; 6), the at least two trimmable portions (5; 6) being located in an area at least adjacent to the upper edge of the calf stop element and to the lower edge of the calf stop element; and (iii) a spacer (2) extending between the footrest (1) and the calf stop element (3).

2. AFO according to claim 1, wherein at least one cuttable portion of the footrest is located in a rear foot region of the footrest, or wherein at least one cuttable portion of the footrest is located in a forefoot region of the footrest.

3. AFO according to claim 1 or claim 2, wherein the footrest comprises at least two trimmable parts, optionally wherein the at least two trimmable parts are located in a rearfoot region and a forefoot region of the footrest.

4. AFO according to any one of the preceding claims, wherein at least one area adjacent to and / or forward of the footrest comprises at least one trimmable portion, optionally wherein the trimmable portion forward of the footrest increases the length of the footrest by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, by at least 2.0 cm or 2.5 cm at its longest point, or by at least 3.0 cm at its longest point.

5. AFO according to any one of the preceding claims, wherein at least one area adjacent to and / or towards a region on one or both sides of the footrest comprises at least one trimmable portion, optionally wherein the trimmable portion along the width of the footrest increases the width of the footrest by at least 0.25 cm at its widest point, by at least 0.5 cm or 1.0 cm at its widest point, or by at least 1.5 cm at its widest point.

6. AFO according to any one of the preceding claims, wherein at least one area adjacent to and / or towards the rear of the footrest comprises at least one trimmable portion, optionally wherein the trimmable portion towards the rear of the footrest increases the length of the footrest by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, by at least 2.0 cm or 2.5 cm at its longest point, or by at least 3.0 cm at its longest point.

7. AFO according to any one of the preceding claims, wherein the footrest comprises at least three or four trimmable parts, optionally wherein an area adjacent to the front of the footrest, an area adjacent to the rear of the footrest, and an area adjacent to a part on both sides of the footrest comprises the trimmable part.

8. AFO according to any one of the preceding claims, wherein at least one cuttable portion extends around the entire peripheral edge of the footrest.

9. AFO according to any one of the preceding claims, wherein the calf stop element comprises a trimmable portion located in an area at least adjacent to the upper edge, the lower edge, and the two lateral edges of the calf stop element.

10. AFO according to any one of the preceding claims, wherein the at least two trimmable parts extend around the entire peripheral edge of the calf stop element.

11. AFO according to any one of the preceding claims, wherein the trimmable portion at the upper edge increases the height of the calf stop element by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, or by at least 2.0 cm or 2.5 cm at its longest point, or wherein the trimmable portion at the upper edge increases the height of the calf stop element by at least 2.0 or 2.5 cm at its longest point, by at least 3.0 or 3.5 cm at its longest point, by at least 4.0 or 4.5 cm at its longest point, or by at least 5.0 cm at its longest point.

12. AFO according to any one of the preceding claims, wherein the trimmable portion at the lower edge increases the height of the calf stop element by at least 0.5 cm at its longest point, by at least 1.0 cm or 1.5 cm at its longest point, or by at least 2.0 cm or 2.5 cm at its longest point, or in which the trimmable portion at the lower edge increases the height of the calf stop element by at least 2.0 or 2.5 cm at its longest point, by at least 3.0 or 3.5 cm at its longest point, by at least 4.0 or 4.5 cm at its longest point, or by at least 5.0 cm at its longest point.

13. AFO according to any one of the preceding claims, wherein the orthosis includes a removable attachment for fixing the calf stop element to a subject's leg.

14. AFO according to any one of the preceding claims, wherein the spacer is connected to the non-cuttable part of the footrest, and to the non-cuttable part of the calf stop element.

15. AFO according to any one of the preceding claims, wherein the spacer comprises or is made of a non-machinable material, optionally wherein the spacer comprises or is made of carbon fibers, fiberglass, or polyester.

16. AFO according to any one of the preceding claims, wherein the cuttable parts of the footrest and calf stop element include guide lines or grooves.

17. AFO according to any one of the preceding claims, wherein the cuttable parts comprise or are made of polyester fibers.

18. AFO according to any one of the preceding claims, wherein the cuttable parts comprise a polymer resin, optionally wherein the cuttable parts comprise between 20% and 60%, between 25% and 55%, between 30% and 50%, or between 35% and 45% polymer resin.

19. AFO according to claim 18, wherein the polymer resin is an epoxy or acrylic resin.

20. AFO according to any one of claims 17 to 19, wherein the trimmable part of the footrest comprises at least two layers of polyester fibers, and / or wherein the at least two trimmable parts of the calf stop element comprise at least two layers of polyester fibers.

21. AFO according to any one of the preceding claims, wherein the non-cuttable portion comprises or is made of carbon fibers.

22. AFO according to any one of the preceding claims, wherein the non-cuttable portion comprises unidirectional fibers and / or bidirectional fibers, optionally wherein the non-cuttable portion comprises bidirectional carbon fibers and unidirectional (UD) carbon fibers.

23. AFO according to any one of the preceding claims, wherein the non-cuttable portion comprises a polymer resin, optionally wherein the non-cuttable portion comprises between 20% and 60%, between 25% and 55%, between 30% and 50%, or between 35% and 45% polymer resin.

24. AFO according to claim 23, wherein the polymer resin is an epoxy or acrylic resin.

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