Method for designing a brace

FIELD OF THE INVENTION

The present invention relates to a method and a system for designing ankle and foot braces. Furthermore, the present invention relates to ankle foot orthotic braces (AFO braces) or dynamic ankle foot orthotic braces (DAFO braces) and a system to design and custom make such braces.

BACKGROUND OF THE INVENTION Braces for supporting walking disabled are well known in the art. Both ankle foot orthotic braces, or AFO braces, as well as dynamic ankle foot orthotic braces, or DAFO braces have been developed to deal with plantar flexion and dorsiflexion problems, such as from ankle injuries or in individuals diagnosed with cerebral palsy.

The prior art braces have been made from plastic or other light materials such as carbon fibres. Several shoe like strapping braces are known, either to be used as a shoe or to fit inside a shoe. Other braces have rigid structure and are built around the ankle and the foot to be worn over clothes and shoes. These can be rigid and unbending ankle braces or hinged ankle braces attached to the sole of the shoe.

When a patient needs an orthoses a doctor or an authorized therapist writes a referral to an orthotist. During the first visit the orthotist undertakes a clinical assessment and an examination of the patient. He also takes a plaster of paris cast of the patient along with the necessary measurements for making the orthoses. After this meeting the orthotist performs positive model rectifications as appropriate and specifies the design, componentry, materials and fabrication method for the orthoses. The patient is called back in to undertake fitting to check the static and dynamic alignment of the orthoses. This may call for one or more visits for the patient. During the patients final visit the orthotist evaluates the completed device on the patient to ensure the desired quality of fit, function, cosmesis and workmanship. After having used the orthoses for an agreed time interval the patient is asked to come back for a re-evaluation.

Because this is a hand made solution the process described above has to be repeated for every orthoses made, even if the patient loses or damages her orthoses.

The term "e-health" represents the crossing of two fields, medicine and informatics, where health services and information is delivered or enhanced through the Internet and related technologies. Remote Medicine extends local e-health services from more than one site and makes it available to remote dispersed locations. Although remote medicine is not as yet used to perform a remote surgical operation on patients, remote medical resources and services are being practiced in the healthcare secotor. Examples of such services are monitoring the health of patients, diagnosis and consultations using data/audio/video links,

websites, e-mail, telephone, fax, as well as any other communications system to exhange information. Modern information technology also provides the opportunity to apply Evidence-Based Medicine (EBM), where medical practice in combination with scientific methods is used to ensure the best prediction of outcomes in medical treatment and making decisions about the care of individual patients based on these methods.

The problem to be solved is to provide a method and a system for making ankle braces minimizing the number of visits to a specialist where the information from the analysis can be obtained from a remote location and wherein the analysis results in a less visible brace.

SUMMARY OF THE INVENTION

The present invention provides a method for designing ankle and foot braces. A subject visits a site for limb movement analysis. By using two or more recording means and a set of test brace components, the limb movements are recorded and analysed. The best or optimal combination is then selected and the information data is recorded and stored for future reference. The information data is then sent to the manufacturer and new brace is built and sent to the user. The methods of the present invention provide a system where the user only has to visit a test site once to have the analysis made and then wait for the new brace. Under most circumstances no further visits are necessary since the right combination has already been found.

In a first aspect of the present invention, a method is provided for designing a brace. The method comprises the steps of recording data using two or more reference components for the brace, analysing the data and selecting the optimal combination of the brace components giving the best limb movement based on said digital data. The selection is then used for the manufacture of a new brace.

In a second aspect of the present invention, a system is provided for designing a brace. The system comprises the following a) two or more recording means for recording limb movements of a subject; b) two or more reference brace components of different characteristics; and c) a background for providing contrast for image analysis. The subject is then positioned between the background and the recording means during the recording step and a selection of brace components is made based on the analysis of the digital data for the manufacture of a new brace.

In a third aspect of the present invention a brace is provided, where the brace is manufactured according to the method and the system of the present invention. The brace is formed from components, the components comprising a brace member and a calf- support member. The calf support member is attached to the brace member such that the

calf support member slides upwards and downwards following the limb movements. The brace member can also comprise an insole member and/or an ankle support member.

In a fourth aspect of the present invention a kit is provided for designing a brace. The kit comprises the following:

• two or more recording means for recording movements of limbs;

• a set of brace components of different size and characteristics;

The operator records limb movement using two or more combinations of brace components, being leg supports, foot plates, insoles and calf supports.

In a fifth aspect of the present invention, a breathable silicon ankle support is provided for supporting limb movements. The ankle support comprises a layer of silicon or perforated silicon, which is covered by two textile layers on each side of the silicon layer. The textile layers are made of a breathable material and prevent the silicon from adhering to the skin. The silicon layer is characterised in that it is of different thickness and stiffness for providing support in different areas of the ankle support. The combination of the breathable textile layer(s) and the perforated silicon layer provides an ankle support which is fully breathable but supports the ankle in a desired manner.

In a further aspect of the present invention, a method is provided for designing limb prosthesis. The method comprises the steps of recording data using two or more reference components making up the prosthetic article, analysing the data and selecting the optimal combination of prosthetic article components giving the best limb movement based on said data. The selection is then used for the manufacture of a new prosthetic article.

DESCRIPTION OF THE PRESENT INVENTION

In an embodiment of the present invention a method is provided comprising recording data of a subjects limb movements as the subject walks a certain path. The limb movements are recorded from one or more angle using digital cameras. The subject walks the same path using a brace combination made from two or more reference or test brace components.

The method of the present invention provides a set of reference brace components, where each brace component is provided with different properties. This means that two or more reference components representing each brace component are provided and the subject will test different combinations of brace components in order to find the best brace for the patient. The brace it self is assembled from a leg support and a foot plate. The number and orientation of fibre layers of each component define the characteristics of each component

and therefore leg support components are created with different flexibility and support characteristics. Therefore, the best combination for a subject may comprise leg support A, foot plate C in the correct shoe size and with calf-support B and the brace will then be manufactured accordingly. (See Fig. 2)

The data are then analysed and the optimal combination of the brace components, giving the best limb movement, is selected based on the data from the recordings. The information is then stored and sent to the manufacturer and the selection is then used for the manufacture of a new brace.

In an embodiment of the present invention an information system is a part of the method and the system of the present invention. The information system includes sending the raw data from the test centre (the person taking the measurements/images of the limb position and movements) to the service provider, which analyses and mines the data. The results from the data analysis are then available to a panel of interdisciplinary parties through a web-interface. These can be any of the following, but not limited to a medical doctor, physiotherapist, the patient or family of a patient and the party which finances the brace (social security authority) etc. After a combination of brace components has been selected the producer receives the information and a new brace is manufactured. The information is then stored in the database and can either be used for making a new brace if the old brace is lost or damaged or worn out, but the information can also be used as a comparison between measurements.

In an embodiment of the present invention different calf-securing braces are tested together with the one or more of the other brace components. The calf-securing brace is a brace in it self designed to fit to the back side of the calf of the subject. The calf-securing brace further comprises a securing means such as a belt or a strap for securing the brace around the leg.

In an embodiment of the present invention the foot plates are attached to the leg-supports in a unique way, which allows a forward movement of the leg-support, but while lifting the foot it locks the foot plate and the leg-support together so it reacts as a one unit. This attachment allows for multiple combinations of various sizes and thicknesses.

In an embodiment of the present invention the braces are made from material such as fibres. The fibre material can be selected from carbon fibres, glass fibres, aramide fibres or a combination thereof.

The fibre brace part of the brace of the present invention is made from layers of fibre material. The flexibility of the brace is dependent on the direction of the fibre material. Therefore, the brace part can be flexible backwards and forward, but not sideways.

In an embodiment of the present invention the recording and analysing the data is performed remotely from a site of manufacture of the brace. Therefore, a person such as a medical doctor, physiotherapist, orthopaedic specialist etc, can perform the analysis and collect all data needed for designing a new brace or prosthesis.

In an embodiment of the present invention pressure measuring device is implemented in one of the brace components for obtaining data of limb pressure to the ground. An example of this is one or more pressure sensors placed in the insole component for detecting limb movements of the subject.

In an embodiment of the present invention data is collect when the subject walks with braces assembled from different brace components. Data is collected by a professional using observations or recording means such as digital recording means, recording the limb movements of a subject from a side view (first data) and from behind (second data).

In a different embodiment the sliding function of the calf-supporting member on the brace member is generated by forming a slot in the leg supporting portion of the brace member and an incline/aperture in the calf-supporting member corresponding to the outlines of the leg supporting portion (shown with a dotted line in Fig. 6. By arranging the calf-supporting member to the in the incline/aperture by means of a bolt or any attachment means the calf-supporting member is able to slide up and down along the slot in the leg supporting portion. It is possible, though, to fasten the calf-support member if the subject does not want to have it slidable.

In an embodiment of the present invention a background is attached to a frame and the subject is positioned between the background and the digital recording means during the recording step of the method. Such background can be a textile material in a single colour, providing a contrast background for image analysis. The background can be attached to the frame in such a manner that a background material is positioned on the opposite side of the recording means both on the side and in front of the subject. A digital recording means is then positioned behind the subject as well as on the side (opposite side of the background frame). Therefore, the digital image of the subject, which is recorded as the subject walks the desired path, there is nothing in the background that interferes with the image.

In an embodiment of the present invention reference points of normal limb movements or standing position are used for the image analysis.

In an embodiment of the present invention an ankle support is provided for supporting limb movements. The ankle support is made from a double textile layer being a breathable material and an intermediate layer of silicon. The silicon layer of the present invention is a breathable silicon layer or a perforated silicon layer, which is positioned between the two

textile layers. The ankle support is characterised by different thickness and stiffness of the silicon layer in different areas of the ankle support for providing support in different areas of the foot. The breathable ankle support can be formed in such a manner that the textile material forms a double layer sock, where the part covering the toes is absent, and the silicon layer is positioned between the two sock layers. Such ankle support is shown in Fig 4. The ankle support is of such thickness that it can be worn on a foot as a normal sock and the subject wearing the sock can also be wearing a shoe. The textile material used in the ankle support can be selected from stretchable and breathable textile materials such as lycra and other materials of similar nature.

In an embodiment of the present invention the breathable ankle support has insole reinforcement or a part of insole reinforcement for supporting the foot. The insole reinforcement can be made from fibre material such as carbon or glass fibres, but the insole can also be made from plastic. The insole reinforcement is used to attach the silicon ankle support to the brace.

In an embodiment of the present invention the breathable ankle support is attached to an ankle brace such as by means of vulcanisation. The advantage of such as brace is that the subject can then be wearing regular shoes and the brace and the calf-securing means can be worn under the trousers. Such an invisible brace is favourable to create more quality of life for moving impaired individuals.

In the present context the brace member is a single object (foot plate and leg support in one piece) with respect to the brace as a product produced according the invention, but the foot plate and leg support are separate components with respect to the method and the kit of the present invention. When the kit is being used in the method of the present invention to define the optimal brace properties, several combinations of foot plates and leg supports are tested, but when a brace is manufactured according the outcome of the analysis a one piece brace member is produced.

In the present context, the term "different characteristics" relating to reference brace components, refers to the fact that each reference brace component is provided, where the brace component is made from different material, with different flexibility, support or stiffness. Some of the brace components are made from carbon fibre layers and the orientation of the layers used to make the component, affects in which direction the brace can be bent and how flexible it is.

In the present context the term "limb movement" refers to the movement and a still standing position of the patient/subject being analysed by the method or the system of the present invention. This includes actions of the subject such as walking, running or standing still.

In the present context the term brace components refers to calf-supports, leg-supports, tempered foot plates and insoles. Different components are put together to select the optimal size and characteristics for the brace.

In the present context the term "prosthetic article" refers to a lower limb prosthesis. The prosthetic article is composed of prosthetic components such as a socket, a last, a knee, connecting components and adaptors.

In the present context the term "data" refers to any data recorded when a subject is moving with a test brace or a test prosthetic article made from two or more reference components. The data can be visual or image data such as but not limited to still photos or video data, digital or optical data. The data can be numerical data recorded in a spread sheet/data sheet format. The data can also be stored for future reference and use for the subject. In the same manner the recording means according to this invention can be a spread sheet for filling in observations manually or a computer with spread sheet for filling in visual observations or numerical observations. The recording means can also be image recording means for taking photos of video images of the patient. Cameras can be both optical and digital cameras. Digital recording means of the present invention is preferably a digital camera, such as a digital video camera.

DETAILED DESCRIPTION OF DRAWINGS

The invention will be described in detail with reference to the following figures, wherein:

FIG. l discloses the system and the method of the present invention.

FIG.2 shows the brace components of the kit.

FIG.3 shows a brace with a calf-supporting member.

FIG.4 shows a brace with a calf-supporting member and an ankle support.

FIG. 5 is an overview of the data management system of the present invention

FIG. 6 shows the foot plate, the leg support and the calf support along with the slot and incline/aperture for the sliding function.

The components required for performing the method of the invention are shown in FIG. 1. On one hand the method requires recording means, which are shown in FIG.l as cameras 1. The movable background 2 is attached to a frame 3 for providing contrast for image analysis. The frame 3 slides in the ground/floor, such as on wheels. The recording means 1

are also attached to the frame 3 in a position to record the movement of the limbs of the subject.

On the other hand the method requires brace components of different sizes and characteristics as shown in FIG.2. A set of reference foot plates 4 and leg supports 5 are provided as well as one or more calf-support members 6. A set of insoles 7 are also provided, where the insoles can all be attached to any one of the reference foot plates.

The ankle brace shown in FIG.3 discloses a brace member (a foot plate 4 and a leg support 5 in one piece) and a calf-supporting member 6. The calf-supporting member 6 has a stiff back-layer 8 supporting the back-side of the calf and a strap 9, which straps the foot to the brace. The strap is fastened by a Velcro fastening means or a buckle 10. This type of an ankle brace can be worn with a regular shoe or attached to the silicon ankle support of the present invention.

The ankle brace in FIG.4 discloses a brace with a calf-supporting member 6 and an ankle support 11. The upper part of the ankle brace shown in FIG. 4 is similar to the ankle brace shown in FIG. 3. The footplate is vulcanised to the ankle support 11. The ankle support is made of silicon and covered with a breathable textile material. The shown member 11 can therefore functions as a shoe or a sandal.

FIG. 5 discloses the data management system of the present invention. Raw data from the analysis of the limb movements are processed and stored in a database. Communication means such as the internet is used to communicate information between the site of analysis and the manufacturer of the brace. The information regarding limb movements and best combination of brace components is stored and can be re-called to make a new brace if needed later on. Furthermore, the information regarding limb movements can be analysed and compared to analysis performed later on, after a period of time.

FIG. 6 discloses the test components applicable in the method and being the components of the kit of the present invention. These are the foot plate 4, the leg support 5 and the calf support 6. The sliding function of the calf-supporting member on the brace member is generated by forming a slot in the leg supporting portion of the brace member and an incline/aperture in the calf-supporting member corresponding to the outlines of the leg supporting portion, shown with a dotted line. By arranging the calf-supporting member to the incline/aperture by means of a bolt or any attachment means the calf-supporting member is able to slide up and down along the slot in the leg supporting portion. It is possible, though, to fasten the calf-support member if the subject does not want to have it slidable