Modular foot prosthesis system
The modular foot prosthesis system addresses the challenge of adaptability and durability in prosthetic foot devices by using a resilient main blade supported at the front and freely suspended, enabling easy adjustments and prolonged use.
Patent Information
- Application Number
- PCT/NL2025/050219
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-08
- Filing Date
- 2025-05-08
- Publication Date
- 2025-08-07
AI Technical Summary
Existing prosthetic foot devices are cumbersome to produce and require re-manufacturing when they fail to meet user requirements or when user needs change, particularly for growing children, and lack adaptability and longevity.
A modular foot prosthesis system comprising a main blade with a resilient material and a toe component, where the main blade is supported at the front section and the remainder is freely suspended for resilient flexing, allowing for easy adaptation to changing user needs and improved durability.
The system enhances usability and longevity by simplifying production and allowing for adjustments as users grow, providing adaptable and durable foot prosthetics.
Smart Images

Figure NL2025050219_07082025_PF_FP_ABST
Abstract
Description
[0001] MODULAR FOOT PROSTHESIS SYSTEM
[0002]
[0001] The present disclosure relates to modular foot prosthesis systems and modular components thereof, in particular a main blade, a toe component, a heel blade and a heel component.
[0003]
[0002] Various prosthetic devices are known to replace a missing body part, such as an extremity or limb of a person. Each type of prosthetic device has a specific design to replace or mitigate the loss of function associated with the missing body part. One type of prosthetic device is a foot prosthesis which serves to take over functions of a (partly) missing foot.
[0004]
[0003] The foot prosthesis can be used to support perambulation of the user in a bipedal gait cycle. The gait cycle consists of a stance phase and a swing phase which alternate for each limb (i.e. leg with a foot or a foot prosthesis, or lower-extremity prosthesis). Starting from the stance phase, the gait cycle comprises heel strike, followed by foot flat, mid-stance and heel rise. The gait cycle then proceeds with the swing phase, comprising toe-off and mid-swing, to recommence again with heel strike of the stance phase.
[0005]
[0004] Foot prostheses are generally developed and manufactured for a specific user including his or her individual requirements. The production of a foot prosthesis is a complicated and timeconsuming process. This process has to be started all over when the foot prosthesis does not meet all user requirements or when user requirements change over time and moreover also when a part of the foot prosthesis wears out.
[0006]
[0005] An objective of the present invention is to provide a foot prosthesis which addresses disadvantages of known prosthetic devices and / or provides improvements, in particular regarding adaptability to changing user requirements, constructional simplicity and longevity. It is a special objective of the inventors to provide a foot prosthesis concept that is of increased useability for children in need of foot and / or lower-extremity prosthetic devices as they grow and develop.
[0007]
[0006] According to a first aspect of the invention, a modular foot prosthesis system is provided which comprises at least a main blade and a toe component. The main blade is made of a resilient material and extends in a lengthwise direction between a front end and a rear end of the main blade and comprises, consecutively from the front end to the rear end: a front section which, in use, is distal from a user of the foot prosthesis system; a spring section for providing spring action; and a rear section coupled or couplable to a connection component which, in use, is proximal to the user. The toe component forms an anterior aspect of a foot prosthesis and is configured to support the main blade. The toe component comprises a first support surface coupled or couplable to the front section of the main blade to fix the front section of the main blade to the toe component and leave the remainder of the main blade freely suspended and / or unsupported for resilient flexing of the main blade relative to the toe component when load is applied by the user.
[0008]
[0007] The front section of the main blade is coupled or couplable to the first support surface of the toe component.
[0009]
[0008] When the first support surface of the toe component is coupled to the front section of the main blade, the front section and first support surface are fixed together, which may define a supported fraction of the main blade, while the remainder of the main blade, which may define an unsupported fraction of the main blade, is freely suspended and / or unsupported so that the rear section may resiliently flex by means of spring action of the spring section relative to the front section that coupled to the toe component, in particular when load is applied by the user of the foot prosthesis system. The supported and unsupported fractions of the main blade are considered in the lengthwise direction of the blade.
[0010]
[0009] It is preferred that only the front section of the main blade and the first support surface of the toe component are connected in use of the foot prosthesis so that the toe component supports the main blade by the front section only and leaves the spring section and the connector section of the main blade freely suspended from the toe component; and
[0011]
[0010] The first support surface of the toe component may correspond to an outer surface (in particular a top or bottom face) of the front section of the main blade. This further improves mutual fit of these components.
[0012]
[0011] The lengthwise direction extends between front and rear ends. The main blade is preferably elongated in shape along the lengthwise direction. A thickness is taken perpendicular to the lengthwise direction and a width is taken perpendicular to both the lengthwise direction and the thickness.
[0013]
[0012] The spring section is formed by that part of the main blade which extends between the front and rear sections of the main blade. The spring section may in particular be delimited by connection or engagements points of the front and rear sections which are innermost relative to the front and rear ends of the main blade. Such connection or engagement points can be formed by through holes, ridges, slots, etc. A similar definition of the rear, spring and front sections may be employed for the heel blade described below.
[0014]
[0013] In use of the foot prosthesis, the various components are assembled. Conventional anatomical directions are used which also apply to the foot prosthesis as it is intended to be used for replacing a missing foot or lower extremity of a user. The prosthesis is then coupled to a stump of the user. Proximal means nearer the body of the user following the lower extremity. Distal means further removed from the body of the user following the lower extremity. Anterior means more forward from the body of the user in a standing posture. Posterior means more rearward from the body of the user in a standing posture. The sagittal plane extends vertically and through a posterior-to-anterior direction in a standing posture of the user. The sagittal plane may in particular pass midway through the foot prosthesis.
[0015]
[0014] Preferably, the main blade is unsupported in the modular foot prosthesis system (when assembled) at the rear section as well as a part the spring section that is adjacent to the rear section. Said part may form most of the spring section as seen in the lengthwise direction from the rear section towards the front section. In this configuration, no (indirect) connections are present between main blade to toe component other than via the front section of the main blade, whereby, when assembled, the main blade is supported by the toe component at the front section only and the spring section and the connector section of the main blade are freely suspended from the toe part.
[0015] Preferably, the modular foot prosthesis system is configured, when assembled, to transfer a load exerted on the rear section of the main blade to the toe component, which load is mitigated only be the spring action of the spring section. The main blade may provide the only mechanical connection between the toe component and the connection component (when present).
[0016]
[0016] The main blade or at least its spring section may be formed of a flat plate. For example, the main blade may be flat, when the main blade is free from load or in an unloaded state. Said plate may be straight, i.e. not bent or curved so that the lengthwise direction of the main blade follows a straight line. However, a flat plate may be shaped to form the main blades, which shaping may include bending.
[0017]
[0017] It is preferred that the main blade or at least its spring section, when free from load, is planar. In other words, the main blade is flat or straight, not curved or bent. It extends in a plane. Though only the spring section may be planar, when the main blade as a whole is planar, manufacturing of a wide variety of main blades is simplified and versatility of the foot prosthesis system is increased.
[0018] The main blade or at least its spring section may have a thickness measured perpendicular to both the lengthwise direction and a widthwise direction with a thickness tolerance of less than 2 mm, preferably less than 1 mm, more preferably less than 0.5 mm. Most preferably, the main blade (or at least its spring section) has a constant thickness, in particular when the main blade is provided in the form of a plat plate. A variation in thickness may be employed. However, as a further development, it is proposed to employ a constant thickness for the main blade, or at least the spring section of the main blade. A constant thickness (i.e. within ordinary manufacturing tolerances) facilitates versatility and ease of manufacturing of the modular foot prosthesis system. Main blades can then be produced from plate material by cutting the appropriate form from such plate material.
[0018]
[0019] The main blade or at least its spring section may have a top surface and a bottom surface with a surface parallelism when free from load of less than 3 mm over 100 mm, preferably less than 2 mm over 100 mm, more preferably less than 1 mm over 100 mm. It is preferred that the bottom surface is parallel to the top surface defining a constant thickness therebetween and / or with a certain thickness tolerance as explained above. The top and bottom surfaces may be planar, though the main blade or at least the spring section thereof may in general be curved even when no load is applied. However, it is preferred that the main blade or at least its spring section is flat (i.e. not curved / bent) and moreover has a constant thickness. Said top and bottom surfaces extend in the lengthwise direction and the widthwise direction of the main blade (or of at least its spring section).
[0019]
[0020] The top surface or top face of the main blade is proximal to the user and may also be termed the proximal face. The bottom surface or bottom face of the main blade is distal to the user, when in use, and may be termed the distal face of the main blade.
[0020]
[0021] The spring section of the main blade may have a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the main blade measured in the widthwise direction. Preferably, the cumulative width profile varies in the lengthwise direction. A width profile of the main blade, or at least of its spring section, can be defined as a cumulative width of resilient material between to the two outermost opposite lateral edges of the main blade measured in the widthwise direction (which is perpendicular to both the lengthwise direction and the thickness of the main blade). The width profile may in general be constant. However, it is preferred that the width profile varies in the lengthwise direction of the main blade. Such variation can be specifically designed to impart desirable spring action characteristics to the spring section of the main blade. An alternative way of imparting such specific performance characteristics to the main blade, or at least its spring section, is the shape the main blade with bends or curves. However, it was found by the present inventors that producing a bent blade is more difficult and curved parts of such a blade are more prone to wear (including delamination) than flat blades.
[0021]
[0022] The cumulative width profile may comprise a variation of at least 5% from a maximum cumulative width. Though a spring section of main blade of constant width may be employed, adjusting its spring characteristics by significant variations in the cumulative width profile are preferred.
[0022]
[0023] The cumulative width profile may comprise one or more than one blade waist defined by a local minimum of the cumulative width profile. A local minimum in the cumulative width profile may be termed a ‘waist’. Such a waist can be provided in various ways as described below. A waist can be used to set a desired flexing point in (the spring section of) the main blade.
[0023]
[0024] At least one of the one or more than one the blade waist may be at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile. In other words, a blade waist or local minimum of the cumulative width profile has a cumulative width that is 95% of the maximum cumulative width or less.
[0024]
[0025] A first blade waist of the one or more than one blade waist may be arranged closer to the front section of the main blade than to the rear section of the main blade. The effect of a waist at such a position is a more upwardly directed spring action during use (e.g. perambulation) of the foot prosthesis. This may be advantageous during a running motion to provide more vertically directed spring action. A second blade waist of the one or more than one blade waist may be arranged closer to the rear section of the main blade than to the front section of the main blade. The effect of a waist at such a position is a more forwardly directed spring action during use of the foot prosthesis. This may be advantageous during a walking motion to provide more horizontally directed spring action. Either or both of these first and second blade waists may be provided, the designation ‘first’ and ‘second’ being merely used to discriminate the two examples. Having both blade waists at these different position in the main blade may result in an advantageous combination of spring characteristics to support various motions of the user.
[0025]
[0026] The variation in cumulative width profile of the main blade, or at least its spring section, can be achieved in various ways, which may be applied separately or in any combination.
[0026]
[0027] A widthwise distance between a right lateral outermost edge and a left lateral outermost edge of the spring section may vary in or along the lengthwise direction. The spring section of the main blade may comprise a right lateral outermost edge and a left lateral outermost edge, which are opposite each other in the widthwise direction and define a widthwise distance between them. Said widthwise distance defines (at least in part) the cumulative width profile. Said right and left lateral outermost edges of the spring section (or of the main blade as a whole) may be symmetric relative to the lengthwise direction (or a least relative to a central line parallel to the lengthwise direction) but may also have different shapes, i.e. be asymmetric. In a variation, the right lateral outermost edge and the left lateral outermost edge of the spring section are asymmetric relative to the lengthwise direction. The spring action may then also be configured to respond to torsional forces in the foot prosthesis system in clockwise or anticlockwise directions in a different way.
[0027]
[0028] The spring section of the main blade may comprise one or more than one through hole. Said through holes define (at least in part) the cumulative width profile, optionally in combination with the widthwise distance between the right and left outermost edges of the spring section. Said one or more than one through hole may comprises an elongated slot extending in the lengthwise direction over at least a part of the spring section. The elongated slot may extend only in the spring section, but not in the front section and / or the rear section of the main blade. Multiple elongated slots may be arranged in the lengthwise direction relative to each other and / or arranged in the widthwise direction relative to each other. These elongated slots may combine with (or in part define) one or more than one slit which separates also the front section of the main blade as described below.
[0028]
[0029] The main blade may comprise one or more than one slit separating the front section and at least a part, preferably most, of the spring section adjacent to the front section into a plurality of lengthwise strips. The slits extend from the front end of the main blade through the front section and into the spring section. It is preferred that the slits do not extend into the rear section. The slits extend in a direction having a component in the lengthwise direction of the main blade. The slits may also extend in the lengthwise direction, e.g. by following a straight line.
[0029]
[0030] Each (or at least one) of the plurality of lengthwise strips may have a strip width profile defined as a width of resilient material present between opposite lateral edges of the respective lengthwise strip, wherein the plurality of strip width profiles jointly defines the cumulative width profile of the spring section. When the main blade has multiple lengthwise strips, their strip width profile may differ. A main blade with multiple lengthwise strips, in particular when these have different strip width profiles, can facilitate inversion and eversion of the foot prosthesis to better mimic such natural movement of the foot.
[0030]
[0031] At least one of the strip width profiles of the plurality of lengthwise strips may vary in or along the lengthwise direction.
[0031]
[0032] Optionally, a first lengthwise strip of the plurality of lengthwise strips comprises a first strip waist defined by a local minimum of the strip width profile of the first lengthwise strip. Further optionally, a second lengthwise strip of the plurality of lengthwise strips comprises a second strip waist defined by a local minimum of the width profile of the second lengthwise strip. Said first and second lengthwise strip may be the same. However, these may also differ, for example with respect to a strip width at the respective strip waist and / or with respect to a position (or distance seen in the lengthwise direction) of the respective strip waist relative to the front end of the main blade. The first strip waist may be positioned nearer the front section of the main blade than the second strip waist and / or the first strip waist may have a smaller strip width than the second strip waist. Spring characteristics may thus differ between first and second lengthwise strips of the main blade.
[0032]
[0033] A widthwise distance between a right lateral edge and a left lateral edge of at least one of the plurality of lengthwise strips may vary in or along the lengthwise direction. For example, the right lateral edge and the left lateral edge of said lengthwise strip may have a different slope and / or curvature in the lengthwise direction. Said right and left lateral edges may be asymmetric relative to a centre line or central plane through the lengthwise strip in the lengthwise direction.
[0033]
[0034] A widthwise distance between two delimiting lateral edges of at least one of the one or more than one slit may vary in or along the lengthwise direction. The delimiting lateral edges of a slit coincide with a right lateral edge and a left lateral edge of two lengthwise strips between which the slit is formed. Slits may be straight, e.g. extend in the lengthwise direction or under an angle relative to the lengthwise direction in a straight line (with or without variation in width). However, one or all of the slits may also be curved. The width of the slit may vary along the lengthwise direction to (at least in part) define the cumulative width profile of the spring section of the main blade. For example, with a curved slit, neighbouring left and right lengthwise sections can have different widths (also depending on the shape of the remaining lateral edges of said lengthwise sections).
[0034]
[0035] Two delimiting lateral edges of a slit among the one or more than one slit may have a different slope and / or curvature in or along the lengthwise direction. These delimiting lateral edges of the slit also define and coincide with two outer edges of neighbouring lengthwise strips that are separated by said slit. These outer edges may thus differ. In particular, these may be asymmetric relative to a plane of symmetry which includes the lengthwise direction and the thickness of the main blade.
[0035]
[0036] Multiple slits can be provided. The one or more than one slit may comprise two slits separating the main blade into at least three lengthwise strips. For example, only two slits may be provided. The main blade may comprise a first slit from the front end through the front section and at least part of the spring section up to the rear section to divide the main blade into at least two lengthwise strips jointly coupled to the rear section. The main blade may further comprise a second split from front end through the front section and the spring section up to the rear section to divide the main blade into at least three lengthwise strips jointly coupled to the rear section.
[0036]
[0037] The plurality of lengthwise strips may comprise three lengthwise strips: a first lengthwise strip, a second lengthwise strip and a third lengthwise strip, wherein the second lengthwise strip is arranged between the first and third lengthwise strips as seen in the widthwise direction. Preferably, the first and third lengthwise strips have a strip width profile different from that of the second lengthwise strip, in particular a strip waist of the first and third lengthwise strips being nearer to the front section of the main blade than a strip waist of the second lengthwise strip and preferably also being nearer to the front section than to the rear section of the main blade. The waist of second lengthwise strip may be nearer to the rear section of the main blade than to the front section of the main blade.
[0038] A particular cumulative width profile of the spring section of the main blade (or in fact also of the heel blade described below) may thus results from a combination of any of the above features, including right and left lateral outermost edges of the spring section, any through holes or elongated slots, any slits and lateral edges thereof and the width profiles of lengthwise strips resulting from these slits as well as variations in or along the lengthwise direction of right and left lateral edges of these lengthwise strips.
[0037]
[0039] The cumulative width profile may comprise a decrease of cumulative width along at least a part of the spring section as seen in the lengthwise direction from the rear section to the front section of the main blade. Said decrease may be linear and / or may extend over a part or even the whole of the spring section. An overall decrease in cumulative width profile from rear to front sections of the main blade is preferred for spring characteristics of the foot prosthesis. Where a blade waist is provided, the cumulative width profile may change from decreasing to increasing.
[0040] A rate of change of the variation in cumulative width profile depends on choice of material. For example, a tangent of the lateral outermost edges of the main blade and / or the later edges of the lengthwise strips may form an angle of less than 45°, preferably less than 25°, relative to the lengthwise direction. A smooth variation of cumulative width profile reduces risk of weak point / accumulation of stress inside in the resilient material of the main blade and improved longevity. These considerations also apply to the width profile of each individual lengthwise strip, when present in the main blade.
[0038]
[0041] The first support surface of the toe component may extend into a first recess which is further formed by a first sidewall extending transversely relative to the first support surface and configured to abut the front end and / or at least one of the lateral edges of the main blade. The first support surface may extend into the recess in an anterior direction. The recess with its sidewall facilitates positioning of the main blade in or on the toe component. Said sidewall may be delimiting the first support surface peripherally. The sidewall may come to abut the main blade or at least one of its lengthwise strips, when present, when the main blade is coupled to the first support surface. The sidewall may serve to align the front end of the main blade relative to the toe component when coupled and any coupling mechanism, such as holes for pins or bolts.
[0039]
[0042] Preferably, the first support surface of the toe component extends in a plane or is planar. This front section of the main blade may also be planar.
[0040]
[0043] The toe component may further comprise a first curved surface arranged adjacent and posterior to the first support surface to support a part of the spring section adjacent to the front section of the main blade when flexed. When the main blade flexes towards the toe component, a part of the spring section that is adjacent to the front section, and which protrudes beyond the first support surface, may come to abut said first curved surface. The first curved surface provides support to the main blade. Its curvature facilitates flexing rather than presenting a pivot or tipping point to the main blade which causes material stresses at that point leading to wear and breaking.
[0044] The first curved surface may have a radius of curvature which decreases in a direction away from the first support surface. A decreasing radius of curvature (thus an increasing curvature) ensure that progressively more distance is available between the main blade (especially when planar) and the support offered by the toe component when moving away from the first support surface along the first curved surface. This improves spring action of the main blade. A further advantage of a decreasing radius of curvature is that the position of a contact point at which the main blade flexes on the first curved surface (e.g. a pivot axis) shifts towards the rear section of the main blade as the main blade flexes further over the first curved surface. As the contact point I pivot axis is thus places at various position rather than at a fixed position on the main blade, stress forces exerted onto the resilient material of the main blade during use are distributed and the durability or longevity of the foot prosthesis is improved.
[0041]
[0045] Preferably, the radius of curvature of the first curved surface corresponds to that of the first support surface at the interface between the first curved surface and the first support surface. This ensures a smooth transition from (planar) first support surface to first curved surface and less stress on the main blade preventing premature breaking of the main blade at this point.
[0042]
[0046] The modular foot prosthesis system, in particular the toe component thereof, may further comprise a second support surface arranged or arrangeable opposite the first support surface to hold the front section of the main blade between the first and second support surfaces. The first support surface may be arranged to abut a first face (e.g. bottom face or bottom surface) of the front section of the main blade and the second support surface may be arranged to abut a second face (e.g. top face or top surface) of the front section of the main blade. The second support surface (just like the first support surface) is coupled or couplable to the front section of the main blade.
[0043]
[0047] The second support surface may extend in a plane, preferably parallel to a plane in which the first support surface extends. Both first and second support surfaces may be planar and define an offset therebetween to receive a thickness of the front section of the main blade.
[0044]
[0048] The first and second support surfaces may define a slotted recess in the toe component to receive the front section of the blade. The first and second support surfaces can be integral with the toe component.
[0045]
[0049] Alternatively, the second support surface may form (a part of) a clamping element which is separate from the toe component. Further, the clamping element may be connected (e.g. by a hinge or strap) to the toe component.
[0046]
[0050] A second curved surface may be arranged adjacent and posterior to the second support surface to support a part of the spring section adjacent to the front section of the main blade when flexed. A part of the spring section which protrudes beyond the second support surface may then be supported by the second curved surface when the main blade flexes towards the second support surface. Both first and second curved surfaces may be provided. The first curved surface may for example support a first face (e.g. bottom face) of said part of the spring section and the second curved surface may then support a second face (e.g. top face) of said part, the first and second faces being opposite faces of the main blade.
[0047]
[0051] The second curved surface has a radius of curvature which decreases in a direction away from the second support surface. The radius of curvature of the second curved surface may correspond to that of the second support surface at the interface between the second curved surface and the second support surface. These features share advantageous as explained above for the first curved surface.
[0048]
[0052] A support length of the first support surface may differ from that of the second support surface so that the main blade, when coupled, is supported at opposite faces over a different lengthwise distance. Alternatively or additionally, the first curved surface and the second curved surface may have different curvature profiles. A different support length and / or a different curvature at the opposite faces of the main blade can reduce undesirable vibrations of the main blade when flexing, or at least avoids vibrational resonances of the main blade in use, in particular in the swing phase of the gait cycle after toe-off. The main blade, when coupled, is then supported at opposite faces at different positions and / or under different angles when flexing over a particular angle in one direction (e.g. upwards) compared to the opposite direction (e.g. downwards). This dampens vibrations and aids in avoiding oscillatory resonances of the main blade.
[0049]
[0053] Another way of providing damping using a damping element is explained hereafter and can be used in combination with or separate from the first / second support surfaces and the first / second curved surfaces of the toe component.
[0050]
[0054] The modular foot prosthesis system may further comprise a damping element of elastic material arranged to dampen a flexing motion of the front end of the main blade towards the user. Motion of the front end of the main blade towards the user occurs, for example, in the swing phase of the gait cycle. At the toe-off moment in the gait cycle, the user’s load is released from the main blade and the spring action of (the spring section of) the main blade causes it to return to its undeformed shaped, thereby flexing back. This may cause undesirable oscillations which can be damped by the damping element. Arranging the damping element such that only this returning flexing motion - with the front end of the main blade moving towards (i.e. in a proximal direction towards) the user - is damped, is advantageous as it does not affect the flexing of the main blade when load is externed into the main blade in the stance phase of the gait cycle by the weight of the user.
[0051]
[0055] The return motion of the main blade can thus be damped by the damping element when the foot prosthesis is lifted from ground (at toe-off in the normal gait cycle). Said flexing motion may be away from the first support element to which the front section of the main blade is to be fixed.
[0052]
[0056] The damping element may be spaced from the top surface of the main blade, when free from load, wherein the top surface is proximal to the user at least at the position of the damping element. Such a spacing results in progressive damping of the main blade when it flexes further.
[0057] The damping element is preferably arranged at or comprised by the toe component at a position opposite the first support surface of the toe component with a spacing between said position and the first support surface for the main blade, said spacing corresponding to the thickness of the main blade or more.
[0053]
[0058] More in general, one or more than one damping element can be provided in the modular foot prosthesis system. At least one damping element can be comprised by the toe component, the heel component and / or the connection component to dampen oscillations of the main blade and / or the heel blade. Such damping may aid in reducing oscillations of said blades when the foot prosthesis system is free from a user’s load, for example during the swing phase of the gait cycle.
[0059] As an alternative or in addition to damping the main blade, one or more than one damping element can also be provided to dampen the heel blade described below. For example, a damping element can be provided on the third support surface and / or the third curved surface of the toe component described below. As another example, a damping element can be provided with the heel component described below, for example at or opposite the support surface and / or the curved surface thereof.
[0054]
[0060] In each case, it is preferred that the damping element is arranged at a spacing from the respective blade it is to dampen so that, when the user’s weight is applied to the foot prosthesis and the blades are flexed under said load (e.g. during stance phase of the gait cycle), the damping element does not interfere with the spring action of said blade but, when said load is released (e.g. during swing phase of the gait cycle), the damping element does engage or contact said blade to dampen any oscillations arising from a return flexing motion of said blade.
[0055]
[0061] The damping element may be made of an elastic material, in particular a compressible elastic material such as a foam or the like. The damping element may be formed from a layer of elastic material, for example arranged at the first and / or second curved surfaces of the toe component.
[0062] A damping element can be arranged at the second curved surface of the toe component, preferably in the form of a damping layer. In other words, the damping element may be formed by a layer of elastic material arranged on the second curved surface. The more rigid second curved surface can then support the less rigid damping element of an elastic material.
[0056]
[0063] The modular foot prosthesis system may comprise a further damping element which is arranged at the first curved surface of the toe component, preferably in the form of a further damping layer. A further damping layer can thus be arranged on the first curved surface.
[0057]
[0064] The toe component may further comprise a bottom face for supporting the user towards an external subsurface. The external subsurface can be the ground or an insole of a shoe or other subsurface on which the user will support himself or herself when using the foot prosthesis.
[0058]
[0065] Preferably, the bottom face comprises a convexly curved outer surface. This may mimic the roundness of toe and / or ball parts of a foot.
[0059]
[0066] The first support surface may be arranged proximal to the user, in use, relative to the bottom face. The main blade can be supported on top of the first support surface so that the main blade does not contact the subsurface in normal use and that forces from the front section of the main blade are transferred downwards onto the toe component.
[0060]
[0067] The first support surface of the toe component may be arranged at or in a top face of the toe component opposite the bottom face of the toe component. The front section of the main blade and any coupling therefor can then be accessed easily from the top face of the toe component.
[0061]
[0068] The first support surface may be arranged opposite the bottom face as seen in a proximal-to- distal direction of the modular foot prosthesis system when in use. Alternatively or additionally, the first support surface of the toe component may be more proximal to the user, when in use, than the bottom face of the toe component and the second support surface, when present, may be more proximal to the user than the first support surface.
[0062]
[0069] In any embodiment of the modular foot prosthesis system disclosed herein, a plurality of toe components may be provided. Each toe component is coupled or couplable to one of the plurality of lengthwise strips of the main blade. Multiple toe components can be provided even when a main blade is used which does not comprise slits, i.e. which is not divided into multiple lengthwise strips. The plurality of toe components may comprise a right toe component and a left toe component separated across the lengthwise direction and / or along a widthwise direction.
[0063]
[0070] For example, two toe components and two lengthwise strips can be provided, wherein each of the two toe components is coupled or couplable to one of the two lengthwise strips of the main blade. In general, a single toe component can be coupled to one or more than one lengthwise strip of the main blade and a single lengthwise strip can be coupled to one or more than one toe component.
[0064]
[0071] As another, at least three toe components and at least three lengthwise strips are provided, wherein each toe component is coupled or couplable to at least one of the at least three lengthwise strips of the main blade.
[0065]
[0072] A connector may be arranged between a first toe component and a second toe component of the plurality of toe components, wherein the connector is configured to comply with relative motion between the first and second toe component up to a predetermined distance between first and second toe components and transfer a force (e.g. a pulling force) from one of the first and second toe components to the other of the first and second toe components when the predetermined distance is reached. The connector may thus couple the first and second toe components when this predetermined distance is reached between these first and second toe component, but allow free relative motion between the first and second toe components when separated below this predetermined distance.
[0066]
[0073] The connector serves to provide a mechanical connection between two or more toe components, e.g. adjacent toe components, so that when one of the connected toe components deflects too much (i.e. more than the predetermined distance), the other connected toe component will also be engaged through the connector. As a result, a larger portion of the main blade, in particular any lengthwise strips of the main blade coupled to the connected toe components, are engaged when the connected toe components are forced to a relative motion that would otherwise go beyond the predetermined distance. Such a distribution of load promotes longevity of the foot prosthesis, in particular its main blade. Multiple toe components can be mechanically connected to distribute a load initially exerted on (only) one toe component over multiple lengthwise strips of the main blade by engaging other connect toe components to which such lengthwise strips are coupled.
[0067]
[0074] The connector can be implemented in various ways. For example, the connector may be coupled to the first and / or second toe component via at least one elongated slot defining the predetermined distance between the first and second toe components. An elongated slot may be comprised by at least one of the band, the first toe component and the second toe component. An elongated slot allows displacement of the connector over its elongation to allow compliance with relative motion between the first and second toe components over a limited range. When multiple elongated slots are combined, these jointly define the predetermined distance over which the first and second toe components can move freely with respect to each other. When the predetermined distance is reached, one or more than one stop may abut a longitudinal end of the elongated slot so that a coupling is made between the first and second toe components in that a force, in particular a pulling force, is transferred from the first to the second toe component or vice versa. This redistribution of peak loads is especially relevant when the foot prosthesis is used in sports or play, e.g. by children for whom accurate control of limb movement and body posture is still under development.
[0068]
[0075] Alternatively or additionally, the connector may comprise a flexible band having a predetermined amount of slack between first and second toe components to define the predetermined distance between the first and second toe components.
[0069]
[0076] The connector may be arranged in recesses at the bottom faces of the respective first and second toe components. This may serve to protect the connector and allow slack of the connector band and / or displacement of the elongated hole(s) inside the recess and thereby reduce unintended interference of the connector with motion between connected toe components.
[0070]
[0077] The modular foot prosthesis system may further comprise a toe cap coupled or couplable to a top face of the toe component. The toe cap is preferably configured to cover the first support surface and at least a part of the front section of the main blade when coupled to the first support surface. The toe cap may also cover the second support surface of the toe component and / or any coupling (e.g. at least one of the first and second releasable couplings described below) between the front section of the main blade and the first and / or second support surfaces.
[0071]
[0078] The modular foot prosthesis system may further comprise a sole cap coupled or couplable to a bottom face of the toe component. The sole cap is preferably configured to cover the third support surface of the toe component and / or any coupling (e.g. the third releasable coupling described below) between the toe component and the heel blade described below.
[0072]
[0079] Though the bottom face of the toe component may be configured for contacting an external subsurface, it is preferred that a sole cap is provided. A bottom surface of the sole cap may be profiled, curved, convex, rounded, grip patterns, etc. A separate sole cap facilitates modular assembly and versatility of the foot prosthesis system. Further, it enables production of the sole cap from materials other than those of the toe component. Finally, the toe and sole cap may be used to cover or shield connectors which couple the toe component to the main blade and / or the heel blade.
[0073]
[0080] A toe assembly of or for a modular foot prosthesis system is also disclosed. The toe assembly comprises at least one of:
[0074] - one or more than one toe component, preferably as disclosed herein;
[0075] - one or more than one toe cap, preferably as disclosed herein; and
[0076] - one or more than one sole cover, preferably as disclosed herein.
[0077]
[0081] Each toe component may be coupled or couplable with one toe cap and one sole cover.
[0082] The modular foot prosthesis system may further comprise a heel blade of a resilient material extending in a lengthwise direction between a front end and a rear end of the heel blade, wherein the heel blade comprises, consecutively from the front end to the rear end:
[0078] - a front section coupled or couplable to the toe component;
[0079] - a spring section for providing spring action; and
[0080] - a rear section coupled or couplable to a heel component.
[0081]
[0083] In use with the user at standing posture, the front section of the heel blade is anterior to the user while the rear section is posterior to the user. The rear section may form a heel component, i.e. the heel blade may have the heel component integrated at its rear section.
[0082]
[0084] Features of the heel blade may correspond to those disclosed herein for the main blade and vice versa. The following beneficial features are in particular presented.
[0083]
[0085] The toe component may further comprise a third support surface coupled or couplable to the front section of the heel blade to fix the front section of the heel blade to the toe component and leave the remainder of the heel blade freely suspended and unsupported for resilient flexing of the heel blade relative to the toe component when load is applied by the user. The third support surface may have a surface normal that is, in use, directed in a distal direction away from the user. The heel blade may contact the toe component from below. The third support surface may be arranged at the bottom face of the toe component. A proximal or top face of the heel blade may be coupled to the third support surface.
[0084]
[0086] The third support surface of the toe component may extend in a plane.
[0085]
[0087] The third support surface of the toe component may extend into a second recess which is further formed by a second sidewall extending transversely relative to the third support surface and configured to abut the front end and / or at least one lateral edge of the heel blade. The second recess is also comprised by the toe component.
[0086]
[0088] The toe component may further comprise a third curved surface arranged adjacent and posterior to the third support surface to support a part of the spring section of the heel blade adjacent to the front section of the heel blade when flexed. The third curved surface may be similar to the first and second curved surfaces of the toe component already described above.
[0087]
[0089] The third support surface of the toe component may be arranged below the first support surface of the toe component as seen in a proximal-to-distal direction in use of the foot prosthesis system. For example, the third support surface is arranged between the first support surface and the bottom face of the toe component.
[0088]
[0090] The heel blade may be coupled to the third support surface from below (as seen in normal use with the user at standing posture) so that, when load is applied, the third support surface pushes onto the front section of the heel blade. Said load may come via the main blade coupled to the first and / or second support surfaces of the toe component at a position more proximal to the user. In particular, the front section of the main blade may press down onto the first support surface of the toe component.
[0089]
[0091] The first support surface of the toe component may extend beyond the third support surface of the toe component as seen in a posterior-to-anterior direction in use of the foot prosthesis system. Alternatively or additionally, the front end of the main blade may extend beyond the front end of the heel blade as seen in a posterior-to-anterior direction in use of the foot prosthesis system. In such configurations, the foot prosthesis presents a more stable arrangement in which forces from the user’s weight are guided effectively.
[0090]
[0092] An angle between the first and third support surfaces of the toe component measured in the sagittal plane and when free from load is in the range of 10 to 80°, preferably 20 to 70°, more preferably 20 to 30°. Alternatively or additionally, an angle between the main blade and the heel blade measured in the sagittal plane and when free from load is in the range of 10 to 80°, preferably 20 to 70°.
[0091]
[0093] The sagittal plane passes through both the anterior-posterior axis and the proximal-distal axis of the foot prosthesis system as designed to be worn by the user in standing posture. In an upright orientation of the assembled foot prosthesis, the main blade is generally positioned with the rear section above the front section. When the main blade is a plate and is free from load, the main blade extends upward under an angle relative to the vertical from the front end to rear end of the blade.
[0092]
[0094] The heel blade is preferably supported horizontally or parallel with respect to a planar external subsurface (at least when free from load and with the foot prosthesis positioned in its upright orientation). In other words, the heel blade may be transverse, in particular perpendicular to, an upright or vertical direction. In any case, it is preferred that an angle between the heel blade and such subsurface in the upright orientation of the prosthesis is less than 5°.
[0093]
[0095] An angle of 25° of the main blade relative to a planar external subsurface (in the upright orientation of the foot prosthesis) is preferred. In such a case, the main blade is at an angle of about 45° relative to such subsurface at the toe-off moment in the gait cycle which than provides forward thrust. This is particularly beneficial when jogging or running with the foot prosthesis.
[0094]
[0096] In any embodiment of the modular foot prosthesis system disclosed herein, it is preferred that the main blade and the heel blade are coupled only via the toe component.
[0095]
[0097] The heel blade may be formed of a flat plate. The shape of heel blade may conform to any of the features disclosed for the main blade, in particular regarding blade waists, cumulative width profile, (elongated) through holes and slits. The heel blade or at least its spring section, when free from load, may be planar. The heel blade or at least its spring section may have a thickness measured perpendicular to both the lengthwise direction and a widthwise direction with a thickness tolerance of less than 2 mm, preferably less than 1 mm, more preferably less than 0.5 mm.
[0096]
[0098] The heel blade or at least its spring section has a top surface and a bottom surface with a surface parallelism when free from load of less than 3 mm over 100 mm, preferably less than 2 mm over 100 mm, more preferably less than 1 mm over 100 mm.
[0097]
[0099] The spring section of the heel blade may have a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the heel blade measured in the widthwise direction, wherein the cumulative width profile of the heel blade varies in the lengthwise direction.
[0100] The cumulative width profile of the heel blade comprises a variation of at least 5% from a maximum cumulative width of the heel blade. The cumulative width profile of the heel blade may in particular be shaped as explained for the main blade, thus including any curved lateral edges, through hole, slits, lengthwise strips and / or asymmetries.
[0098]
[0101] The cumulative width profile of the heel blade comprises one or more than one blade waist defined by a local minimum of the cumulative width profile of the heel blade.
[0099]
[0102] At least one of the one or more than one the blade waist may be at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile of the heel blade.
[0100]
[0103] At least one of the one or more than one the blade waist is arranged at a position in the lengthwise direction of the heel blade in the range of 20 to 80% of the total length of the heel blade. It is preferred that a blade waist of the heel blade is positioned roughly centrally relative to the length of the heel blade.
[0101]
[0104] The modular foot prosthesis system may comprise a plurality of heel blades. Each heel blade may be coupled or couplable to at least one of a plurality of toe components comprised by the foot prosthesis system. Alternatively or additionally, the heel blade may comprise splits as explained for the main blade. Such splits extend in the lengthwise direction of the heel blade to divide the heel blade into a plurality of lengthwise strips. Each lengthwise strip of the heel blade may be connected to the remainder of the heel blade via the rear section or the front section of the heel blade.
[0102]
[0105] The modular foot prosthesis system may further comprise a heel component forming a posterior aspect of the foot prosthesis and comprising a support surface coupled or couplable to the rear section of the heel blade. Said support surface may have a surface normal directed in a proximal direction towards the user. The heel blade may then be arranged on top of the support surface of the heel component.
[0103]
[0106] The support surface of the heel component may extend in a plane or be planar.
[0104]
[0107] The heel component may further comprise a curved surface arranged adjacent and anterior to the support surface of the heel component to support a part of the spring section adjacent to the rear section of the heel blade when flexed. Preferably, the curved surface of the heel component has a radius of curvature which decreases in a direction away from the support surface of the heel component.
[0105]
[0108] The support surface of the heel component and the third support surface of the toe component may extend in parallel planes, when the heel blade is coupled thereto and free from load, to support the heel blade relative to a planar external subsurface under an angle in the sagittal plane of less than 20°, preferably less than 10°, more preferably less than 3° or even parallel to said subsurface.
[0106]
[0109] The support surface of heel component and the third support surface of the toe component can be arranged such that the heel blade is supported equidistant, or at least within the angle just mentioned, relative to a planar external subsurface when the foot prosthesis abuts said subsurface in its upright orientation at the toe component and the heel component, e.g. by means of the bottom faces of these components.
[0110] The heel component may further comprise a bottom face for supporting the user towards an external subsurface.
[0107]
[0111] The bottom face may comprise a recess with a slotted rim for coupling replacement sole elements into the heel component. A similar slotted rim may also be arranged at the bottom face of the toe component for similar replacement soles.
[0108]
[0112] The heel component may comprise a sidewall extending transversely relative to the support surface of the heel component and configured to abut the rear end and / or at least one lateral edge of the heel blade.
[0109]
[0113] The heel component may comprise a protruding rim which is configured to receive the rear end of the main blade when the main blade and the heel blade are flexed towards each other. Said protruding rim extends in an upward direction, i.e. in a proximal direction towards the user when the foot prosthesis is in use.
[0110]
[0114] Preferably, the heel component is only connected to the toe component via the heel blade, or via the plurality of heel blades when more than one heel blade is provided.
[0111]
[0115] The modular foot prosthesis system may comprise a plurality of heel components each coupled or couplable to at least one of a plurality of heel blades (or lengthwise strips thereof) comprised by the foot prosthesis system. In particular, two heel blades may be provided, each coupled to one of the two heel components. Three or more heel blades and / or heel components can also be employed. Alternatively, a single heel component can be used.
[0112]
[0116] The number of heel blades may correspond to the number of heel components, which may further correspond to the number of lengthwise strips of the main blade and to the number of toe components. Generally, these numbers need not be the same.
[0113]
[0117] A heel assembly of or for a modular foot prosthesis system is also disclosed. The heel assembly comprises at least one of:
[0114] - one or more than one heel blade, preferably as disclosed herein; and
[0115] - one or more than one heel component, preferably as disclosed herein.
[0116]
[0118] Each to heel blade component may be coupled or couplable with one heel blade. Each heel blade may further by coupled or couplable to a toe assembly, preferably a toe component thereof.
[0117]
[0119] The modular foot prosthesis system may further comprise the connection component coupled or couplable to the rear section of the main blade.
[0118]
[0120] Preferably, the connection component is only connected to the toe component via the main blade.
[0119]
[0121] The connection component may comprise a joint, such as a prosthetic ankle joint.
[0120]
[0122] The modular foot prosthesis system may further comprise an auxiliary blade. The auxiliary blade extends in a lengthwise direction between a front end and a rear end of the auxiliary blade and comprises, consecutively from the front end to the rear end:
[0121] - a front section coupled or couplable to the connection component;
[0122] - optionally, a spring section for providing spring action; and
[0123] - a rear section for coupling to an auxiliary connection component proximal to the user.
[0123] The auxiliary blade may be formed of a resilient material. However, it may also be rigid. The spring section is therefore optional. In the foot prosthesis system, it is preferred that at least the main blade is resilient and has a spring section to provide spring action to the foot prosthesis.
[0124]
[0124] The auxiliary blade may be formed from or as a flat plate.
[0125]
[0125] Preferably, the auxiliary blade or at least its spring section, when free from load, is planar. The auxiliary blade may have the same thickness tolerance and / or parallelism as indicated above for the main blade or heel blade(s).
[0126]
[0126] The auxiliary blade, in particular the spring section of the auxiliary blade, may comprise a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the auxiliary blade measured in the widthwise direction comprising a variation of at least 5% from a maximum cumulative width of the auxiliary blade and / or one or more than one blade waist which is at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile of the auxiliary blade. Other features described herein for the main blade or the heel blade are likewise applicable to the auxiliary blade.
[0127]
[0127] The main blade and the auxiliary blade are coupled or couplable to the connection component under an angle measured in the sagittal plane and when free from load that is at least 10°, preferably in the range of 10 to 170°, more preferably in the range of 10 to 80°. In some embodiments, this angle may be in the range of 15 to 75°.
[0128]
[0128] Further, the angle between the auxiliary blade and the main blade may correspond to the angle formed between the main blade and the heel blade. This provides a Z-like configuration of the blades in the foot prosthesis when viewed from the appropriate side of the sagittal plane. This enables a very low build of the foot prosthesis, which is useful, for example, when the user only requires a prosthetic device at or below the ankle.
[0129]
[0129] The modular foot prosthesis system may further comprise the auxiliary connector component coupled or couplable to the rear section of the auxiliary blade.
[0130]
[0130] The auxiliary connection component may comprise a joint, such as a prosthetic ankle joint or a prosthetic knee joint.
[0131]
[0131] It is preferred that the various modular components are releasably couplable. The main blade may be releasably couplable to the toe component, in particular the first support surface thereof, and / or to the connection component, in particular at the front and rear sections of the main blade, respectively. Likewise, the heel blade may be releasably couplable to (the third support surface of) the toe component and / or to (the support surface of) the heel component, in particular at the front and rear sections of the heel blade, respectively.
[0132]
[0132] The modular nature of the foot prosthesis system allows easy adjustment of the foot prosthesis by adapting or exchanging components. For example, as a child grows and matures, it is desirable to adjust the overall size of the foot prosthesis to match that of a foot of the child and to increase the weightbearing capacity of the foot prosthesis. The foot prosthesis can then be adjusted by replacing the main blade and / or the heel blade for a longer and stronger version while toe and heel components may continue to be used. Further advantage is that a range of standardized components can be kept in store to select depending on individual user requirements and assemble into a foot prosthesis for a specific user.
[0133]
[0133] The modular foot prosthesis system may further comprise at least one of:
[0134] - a first releasable coupling arranged to releasably couple the front section of the main blade to the first support surface of the toe component;
[0135] - a second releasable coupling arranged to releasably couple the front section of the main blade to the second support surface of the toe component;
[0136] - a third releasable coupling arranged to releasably couple the front section of the heel blade to the third support surface of the toe component;
[0137] - a fourth releasable coupling arranged to releasably couple the rear section of the heel blade to the support surface of the heel component; and
[0138] - a fifth releasable coupling arranged to releasably couple the rear section of the main blade to the connection component.
[0139]
[0134] Any combination of these first to fifth releasably couplings can be provided. The first and second releasably coupling may in particular be combined into a single releasable coupling. The releasably couplings may be implemented in various ways. At least one of the first to fifth releasable couplings may comprise a clamp, a slot and pin connection, a biased locking lip connection or a bolt connection. A clamp may be biased with a spring to provide a coupling force. A slot (e.g. slotted recess) may be provided for sliding a blade into said slot and lock it in place with a pin or other locking element. A biased locking lip may be used to implement a snap lock with said lip locking into or behind an edge or rim. A bolt connection can be implemented with threaded hole in e.g. the toe component and through hole in front section of main blade. Using bolts is preferred as it readily allows for coupling of blades of different thicknesses without conceding on connection strength.
[0140]
[0135] Same or similar mechanism can be used to couple the rear section of the main blade and / or the front section of the auxiliary blade to the connector component.
[0141]
[0136] A combination of releasable couplings may be used. For example, the main blade can be coupled to the toe component with two bolts for each lengthwise strip. The (or each) heel blade can be coupled to the toe component and / or to the heel component with one bolt in combination with a slot and pin connection. Further, the recesses with sidewalls of the toe component and / or the heel component may serve to prevent rotation of the respective blade, particularly in the plane of the blade, about the bolt or other coupling used there.
[0142]
[0137] For example, a first hole is arranged in the front section of the main blade and a second hole is correspondingly arranged in the first support surface of the toe component to releasably couple the main blade to the toe component with a first pin or bolt arranged through the first and second holes. The pin or bolt can be inserted through the first and second holes to couple the main blade and the toe component. At least one of the first and second hole may be a threaded hole to engage with a bolt. One may be a through hole and the other may be a blind hole or both may be through holes. It is preferred that only one of these holes, e.g. the second hole in the form of a blind hole, is threaded to engage with a bolt to fix the main blade to the toe component.
[0138] In a further and similar example, a third hole is arranged in the front section of the heel blade and fourth hole is correspondingly arranged in the third support surface of the toe component to releasably couple the heel blade to the toe component with a second pin or bolt arranged through the third and fourth holes.
[0143]
[0139] Similarly, the rear section of the main blade may be made releasably couplable to the connector component by means of holes and a pin or bolt. In particular, one or more than one through hole may be arranged in the rear section of the main blade and one or more than one blind hole may correspondingly be provided in the connector component to releasably couple the main blade to the connector component with one or more than one bolt arrangeable through said through hole and blind hole.
[0144]
[0140] In a further example, a fifth hole is arranged in the rear section of the main blade for aligning with a sixth hole correspondingly arranged in the connection component to releasably couple the main blade to the connection component with a third pin or bolt arranged through the fifth and sixth holes. One or both of the fifth and sixth holes may likewise be threaded for coupling with a bolt, and each both be a through hole or one (preferably the sixth hole) may be a blind hole and the other (preferably the fifth hole) a through hole, in which case it is preferred that at least the blind hole is threaded.
[0145]
[0141] Various choices can be made as to materials for the components of the modular foot prosthesis system.
[0146]
[0142] The resilient material of the main blade and / or the heel blade and / or the auxiliary blade may be formed of or comprise a laminate. Said laminate may comprise one or more than one composite layer. The composite layer may comprise a fibre-reinforced resin, preferably comprising glass fibres and / or carbon fibres.
[0147]
[0143] The toe component may be formed of a composite material in which one or more than one insert is arranged. Said insert may comprises an internal thread for engaging an external thread of a coupling device, such as a bolt, to fix at least one of the main blade, the heel blade, the toe cap and the sole cap to the toe component.
[0148]
[0144] The heel component may likewise be formed of a composite material in which one or more than one insert is arranged, wherein the insert comprises an internal thread for engaging an external thread of a coupling device, such as a bolt, to fix the heel blade to the toe component.
[0149]
[0145] The insert(s) can be formed of a metal, preferably titanium.
[0150]
[0146] The composite material can be formed of fibre-reinforced resin moulded around the metal inserts. Preferably, the fibre-reinforced resin has fibres in a random orientation. Alternatively or additionally, the fibres comprise or are carbon fibres. Use of randomly oriented carbon fibres is preferred for strength, durability and production efficiency. For example, so-called forged composite or forged carbon can be used for the toe component and / or the heel component.
[0151]
[0147] The toe component or the heel component or both can generally be made of various materials and in various ways. For example also by milling the component from a piece of metal, preferably titanium, by curing a composite material in a mould, by laminating the component, injection moulding with composites or plastics, such as glass-fibre reinforced nylon.
[0148] In any of the embodiments disclosed herein, the modular foot prosthesis system may further comprise a bottom support blade (or first support blade) which is arranged or arrangeable between the first support surface of the toe component and the main blade. The bottom support blade may extend from the front section of the main blade along a part of the spring section of the main blade clearing the rear section of the main blade. In other words, it is preferred that the bottom support blade extends from the front section of the main blade along only a part of the spring section of the main blade. The bottom support blade thus stays clear of the rear section of the main blade. In particular, the bottom support blade may be fastened to (only) the front section of the main blade and be freely suspended therefrom extending along the spring section of the main blade over a distance smaller than the distance between front and rear sections of the main blade.
[0152]
[0149] In such embodiments, the modular foot prosthesis system may further comprise a bottom slide layer (or first slide layer) interposed between the bottom support blade and the main blade. Preferably, the bottom slide layer is fastened to the main blade only at the front section thereof.
[0153]
[0150] Alternatively or additionally to the bottom / first support blade, the modular foot prosthesis system may in any embodiment comprise a top support blade (or second support blade) which is arranged or arrangeable over the top surface of the main blade. When the connection component is present, the top support blade is preferably arranged between the main blade and the connection component. The top support blade extends from the rear section of the main blade along a part of the spring section of the main blade clearing the front section of the main blade. In other words, it is preferred that the top support blade extends from the rear section of the main blade along only a part of the spring section of the main blade. The top support blade thus stays clear of the front section of the main blade. In particular, the top support blade may be fastened to (only) the front rear of the main blade and be freely suspended therefrom extending along the spring section of the main blade over a distance smaller than the distance between rear and front sections of the main blade.
[0154]
[0151] In such embodiments, the modular foot prosthesis system may further comprise a top slide layer (or second slide layer) interposed between the bottom support blade and the main blade. Preferably, the top slide layer is fastened to the main blade only at the rear section thereof.
[0155]
[0152] According to a second aspect of the invention, the present disclosure provides a main blade of or for a modular foot prosthesis system as disclosed herein.
[0156]
[0153] In particular, a method of manufacturing such a main blade is also disclosed. Said method comprises cutting a plate of resilient material into the shape of the main blade.
[0157]
[0154] The method may comprise providing said plate, determining a shape for the main blade and cutting said shape out of the plate. Said cutting may involve cutting the external outlines of the main blade, including the width profile and any lengthwise slits, as well as cutting internal outlines, including any (elongated) through holes. This cutting operation may be implemented with technologies such as sawing, water-cutting, laser-cutting and milling. Shaping the outlines involves providing the cumulative width profile of the spring section of the main blade.
[0158]
[0155] The same techniques can be used for providing the heel blades and / or the support blades.
[0156] Laminates can easily be made in plate form, which plates can then be cut into the desired length and width dimensions to form main blades and heel blades for the modular foot prosthesis system as disclosed herein for wide-ranging user requirements. Even when user requirements change over time, such as with growing children, the foot prosthesis system can easily be adapted by exchanging the main and / or heel blades. Cumbersome and time-intensive and therefore costly production of curved blades can be avoided. The present invention provides a versatile, adaptable modular foot prosthesis system that requires less cost and effort to adjust and thus makes appropriate foot prostheses available to more people, including children of all ages.
[0159]
[0157] According to a third aspect of the invention, the present disclosure provides a toe component of or for a modular foot prosthesis system as disclosed herein.
[0160]
[0158] In particular, a method of manufacturing such toe component is also disclosed. Said method may comprise:
[0161] - positioning inserts into a mould shaped to form the toe component;
[0162] - filling the mould with fibre-reinforced resin, in particular using randomly oriented fibres of carbon and / or glass;
[0163] - allowing the resin to cure, preferably under the application of pressure and / or temperature control, more preferably to obtain a forged composite; and
[0164] - opening the mould to obtain the toe component having the inserts embedded in the cured resin.
[0165]
[0159] The toe component is preferably manufactured with metal inserts of titanium and with forged carbon.
[0166]
[0160] The same techniques can be used for providing the heel component, for which an appropriate heel component mould can be provided.
[0167]
[0161] According to a fourth aspect of the invention, the present disclosure provides a blade of or for a modular foot prosthesis system as disclosed herein.
[0168]
[0162] In particular, a method of manufacturing such heel blade is also disclosed. Said method comprises cutting a plate of resilient material into the shape of the heel blade. Similar techniques as disclosed for the main blade can be applied for the manufacturing of heel blades.
[0169]
[0163] According to a fifth aspect of the invention, the present disclosure provides a heel component of or for a modular foot prosthesis system as disclosed herein.
[0170]
[0164] In particular, a method of manufacturing such heel component is also disclosed. Said method may comprise:
[0171] - positioning inserts into a mould shaped to form the heel component;
[0172] - filling the mould with fibre-reinforced resin, in particular using randomly oriented fibres of carbon and / or glass;
[0173] - allowing the resin to cure, preferably under the application of pressure and / or temperature control, more preferably to obtain a forged composite; and
[0174] - opening the mould to obtain the heel component having the inserts embedded in the cured resin.
[0175]
[0165] The disclosure also provides a toe component mould that is specifically configured to provide the toe component as disclosed herein as well as a heel component mould that is specifically configured to provide the heel component as disclosed herein.
[0166] In a sixth aspect of the invention, a lower-extremity prosthesis is provided which comprises at least one of:
[0176] - a modular prosthesis system according to the first aspect;
[0177] - a main blade according to the second aspect and / or obtainable according to the method of manufacturing a main blade as disclosed herein;
[0178] - a toe component according to the third aspect and / or obtainable according to the method of manufacturing a toe component as disclosed herein;
[0179] - a heel blade according to the fourth aspect and / or obtainable according to the method of manufacturing a heel blade as disclosed herein; and
[0180] - a heel component according to the fifth aspect and / or obtainable according to the method of manufacturing a heel component as disclosed herein.
[0181]
[0167] In a seventh aspect of the invention, a method of adapting a lower-extremity prosthesis is disclosed, which lower-extremity prosthesis comprises at least one of the main blade and the heel blade, the method comprising at least one of:
[0182] - adapting the width profile of the spring section of the main blade; and
[0183] - adapting the width profile of the spring section of the heel blade.
[0184]
[0168] The technology presented here provides great versatility in assembling a new foot prosthesis and / or adapting an existing foot prosthesis according to user requirements. For example, making the main blade and / or the heel blade out of resilient plate material simplifies production compared to blades that are manufactures into a curved shape. Further, the blades can easily be exchanged and may also be easily adjusted by adapting the width profile (e.g. by taking away material from the lateral outer edges, providing a through hole inside the blade and / or adjusting the lateral inner edges of a lengthwise slit).
[0185]
[0169] Adapting a foot prosthesis or a lower-extremity prosthesis may alternatively or additionally comprise at least one of:
[0186] - replacing a main blade, preferably involving releasably coupling a main blade according to the present disclosure to the first support surface of a toe component according to the present disclosure; and
[0187] - replacing a heel blade, preferably involving releasably coupling a heel blade according to the present disclosure to the second support surface of a toe component according to the present disclosure and / or to the support surface of a heel component according to the present disclosure.
[0188]
[0170] The modular foot prosthesis system may comprise the following mutually compatible modular components: main blade, toe component, heel blade and heel component. Though it is preferred to combine all four of these modular components to form a foot prosthesis, a functional foot prosthesis may already be formed by using only a main blade and a toe component. The heel blade and the heel component are optional. In general, any one of - or any combination of - the four components can be used for modularly assembling a foot prosthesis or lower-extremity prosthesis, in which pre-existing components may also be employed along with components according to the present disclosure (e.g. in retrofit).
[0171] It is noted that each of the modular components disclosed here - in particular the main blade, the toe component, the heel blade and the heel component - defines a further aspect of the present disclosure and may be an invention in its own right that is related to a different problem or has different advantages relative to the prior art.
[0189]
[0172] These aspects are further explained using the following figures, in which:
[0190] FIG. 1 - 9 show an example of a modular foot prosthesis system under skew angles (FIG.
[0191] 1 and 2), as exploded views (FIG. 3 and 4) and in multiple orthographic views (FIG. 5 - 9);
[0192] FIG. 10 - 14 show an example of a main blade in multiple orthographic views;
[0193] FIG. 15 - 22 show further examples of main blades in a plan view;
[0194] FIG. 23 - 27 show an example of toe component in multiple orthographic views;
[0195] FIG. 28 and 29 show an example of a releasable coupling between main blade and toe component with first and second curved surfaces and an optional damping element;
[0196] FIG. 30 shows an example of a toe component with inserts;
[0197] FIG. 31 - 35 show an example of heel blade in multiple orthographic views;
[0198] FIG. 36 - 41 show an example of a heel component in multiple orthographic views;
[0199] FIG. 42 and 43 show exploded views of further modular foot prosthesis systems which include a toe cap and a sole cap;
[0200] FIG. 44 - 49 show various configurations of modular foot prosthesis systems with an optional connection component and / or an optional auxiliary blade; and
[0201] FIG. 50 - 53 show another example of a modular foot prosthesis system under skew angles (FIG. 50 and 51 ) and as exploded views (FIG. 52 and 53).
[0202]
[0173] The following reference symbols are used throughout the figures and associated description.
[0203] 1 main blade
[0204] 2 toe component
[0205] 3 heel blade
[0206] 4 heel component
[0207] 5 front end
[0208] 6 rear end
[0209] 7 front section
[0210] 8 spring section
[0211] 9 rear section
[0212] 10 connection component
[0213] 11 f i rst s u ppo rt s u rf ace
[0214] 12 support surface
[0215] 13 lateral outermost edge
[0216] 14 top surface
[0217] 15 bottom surface
[0218] 16 through hole
[0219] 17 slit
[0220] 18 lengthwise strip 19 lateral edge
[0221] 20 connection hole
[0222] 21 bolt
[0223] 22 connector
[0224] 23 elongated slot
[0225] 24 recess
[0226] 25 bottom face
[0227] 26 convexly curved outer surface
[0228] 27 top face
[0229] 28 first recess
[0230] 29 first sidewall
[0231] 30 first curved surface
[0232] 31 second support surface
[0233] 32 second curved surface
[0234] 33 releasable coupling
[0235] 34 clamping element
[0236] 35 damping element
[0237] 36 insert
[0238] 37 internal thread
[0239] 38 third support surface
[0240] 39 second recess
[0241] 40 second sidewall
[0242] 41 third curved surface
[0243] 42 curved surface
[0244] 43 recess of heel component
[0245] 44 slotted rim
[0246] 45 sidewall
[0247] 46 recess
[0248] 47 protruding rim
[0249] 48 toe cap
[0250] 49 sole cap
[0251] 50 accommodation
[0252] 51 auxiliary blade
[0253] 52 pyramidal coupling
[0254] 54 auxiliary connection component
[0255] 55 upright blade or post
[0256] 56 protrusion
[0257] 57 hole
[0258] 58 top support blade
[0259] 59 bottom support blade 60 top slide layer
[0260] 61 bottom slide layer
[0261] D1 , D2, ... distance
[0262] LD lengthwise direction
[0263] R1 , R2, ... radius of curvature
[0264] TD thickness direction
[0265] WD widthwise direction
[0266] W1 , W2, ... blade width
[0267] W1 W2’, ... strip or partial width
[0268]
[0174] FIG. 1 and 2 show an example of a modular foot prosthesis system in an assembled state under skew angles from above and below, respectively. In the assembled state, the modular foot prosthesis system may simple be referred to as a foot prosthesis. The same example is shown in exploded views from above and below in FIG. 3 and 4, respectively. Multiple orthographic views of this example are presented in FIG. 5 - 9, of which FIG. 5 is a bottom view onto a distal end of the modular foot prosthesis system, FIG. 6 is a front view thereof, FIG. 7 is a side view or lateral view thereof, FIG. 8 is a rear view onto a posterior end thereof and FIG. 9 is a top view onto a proximal end thereof. The illustrated example of the modular foot prosthesis system comprises a single main blade 1 , two toe components 2, two heel blades 3 and two heel components 4.
[0269]
[0175] The main blade 1 is made of a resilient material extending in a lengthwise direction LD between a front end 5 and a rear end 6 of the main blade 1 . The main blade 1 may comprises, consecutively from the front end 5 to the rear end 6: a front section 7 which, in use, is distal from a user of the foot prosthesis system, a spring section 8 for providing spring action, and a rear section 9 coupled or couplable to a connection component 10 which, in use, is proximal to the user. The connection component 10 is optional. Details of the main blade 1 of this example are further explained with FIG. 10 - 14. Multiple variations of the main blade 1 are illustrated and explained with FIG. 15 - 22.
[0270]
[0176] The toe component 2 forms an anterior aspect of the assembled foot prosthesis and is configured to support the main blade 1 . To this end, the toe component 2 comprises a first support surface 11 coupled or couplable to the front section 7 of the main blade 1 to fix said front section 7 to the toe component 2 and leave the remainder of the main blade 1 freely suspended and unsupported for resilient flexing thereof relative to the toe component 2 when load is applied by the user onto the main blade 1 . Details of the toe component 2 according to this example and further variations are explained with FIG. 23 - 30.
[0271]
[0177] The heel blade 3 is made of a resilient material extending in a lengthwise direction LD between a front end 5 and a rear end 6 of the heel blade 3. The heel blade 3 may comprises, consecutively from its front end 5 to its rear end 6: a front section 7 coupled or couplable to the toe component 2, a spring section 8 for providing spring action, and a rear section 9 coupled or couplable to the heel component 4. Details of the heel blade 3 according to this example and further variations are explained with FIG. 31 - 35.
[0178] The heel blade 3 may include any features disclosed herein for the main blade 1 . Likewise, the main blade 1 may include any features disclosed herein for the heel blade 3, in particular that two or more main blades 1 can be provided just like two or more heel blades 3 can be provided in the modular foot prosthesis system.
[0272]
[0179] The heel component 4 forms a posterior aspect of the foot prosthesis and comprises a support surface 12 coupled or couplable to the rear section 9 of the heel blade. The heel component 4 according to this example and further variations thereof are explained with FIG. 36 - 41.
[0273]
[0180] FIG. 10 - 14 show the main blade 1 in multiple orthographic views, of which FIG. 10 is a front view onto the front end 5 of the main blade 1 , FIG. 1 1 is a side view onto a first or right lateral outermost edge 13 thereof, FIG. 12 is a plan view onto the top or proximal surface 14 thereof, FIG. 13 is a side view onto a second or left later outermost edge 13 thereof, and FIG. 14 is a rear view onto the rear end 6 thereof.
[0274]
[0181] The illustrated main blade 1 can be formed of a flat plate. When the main blade 1 is free from load (i.e. it is at rest and not deformed by external forces), it is planar. The main blade 1 has a thickness T as measured perpendicular to both the lengthwise direction LD and a widthwise direction WD with a thickness tolerance of less than 2 mm, preferably less than 1 mm, more preferably less than 0.5 mm. In particular, the thickness T may be constant.
[0275]
[0182] The main blade 1 has a top surface 14 and a bottom surface 15 with a surface parallelism, when the main blade 1 is free from load, of less than 3 mm over 100 mm, preferably less than 2 mm over 100 mm, more preferably less than 1 mm over 100 mm.
[0276]
[0183] What is stated here about the main blade 1 being formed of a flat plate, being planar, having thickness tolerances and / or surface parallelism may all equally apply at least to the spring section 8 of the main blade 1 , while the front section 7 and / or the rear section 9 of the main blade 1 may deviate from these features. For example, the front section 7 may have a thickness or thickness tolerance which differs from that of the spring section 8.
[0277]
[0184] The spring section 8 of the main blade 1 (or even the main blade 1 as a whole) has a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges 13 of the main blade 1 measured in the widthwise direction WD. The cumulative width profile varies in the lengthwise direction LD. The cumulative width profile in particular comprises a variation of at least 5% from a maximum cumulative width.
[0278]
[0185]
[0279]
[0186] The cumulative width profile can be designed with one or more than one blade waist W1 - W5, which is defined by a local minimum of the cumulative width profile. A blade waist may be defined as being at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile.
[0280]
[0187] As illustrated in the examples of the main blades 1 , the cumulative width profile can be formed by shaping the spring sections 8 of the main blades 1 in various alternative and additional ways:
[0281] - a widthwise distance between the right lateral outermost edge 13 and the left lateral outermost edge 13 of the spring section 8 varies in the lengthwise direction LD, wherein the right lateral outermost edge 13 and the left lateral outermost edge 13 of the spring section 8 may be asymmetric relative to the lengthwise direction LD;
[0282] - one or more than one through hole 16 is provided in the spring section 8, optionally in the form of an elongated slot extending in the lengthwise direction LD over at least a part of the spring section 8; and
[0283] - the main blade 1 comprises one or more than one slit 17 separating the front section 7 and at least a part, preferably most, of the spring section 8 adjacent to the front section 7 into a plurality of lengthwise strips 18, wherein a strip width profile defined as a width of resilient material present between opposite lateral edges 19 of the respective lengthwise strip 18 may vary in the lengthwise direction LD, optionally with one or more than one strip waist W1 ’ - W3’.
[0284]
[0188] A first blade waist W1 of the one or more than one blade waist is arranged closer to the front section of the main blade than to the rear section of the main blade. A second blade waist of the one or more than one blade waist is arranged closer to the rear section of the main blade than to the front section of the main blade.
[0285]
[0189] FIG. 12 shows a main blade 1 with symmetric lateral outermost edges 13 with a single slit 17 to define two lengthwise strips 18. The width of the slit 18 in this specific example decreases from the front end 5 of the main blade 1 towards the rear section 9. In particular, the slit 17 has a constant width over the front section 7 and then decreases in width (linearly), along the lengthwise direction LD in the spring section 8. The slit 17 terminates near the rear section 9 and thus extends over only a part of the spring section 8. A lateral edge 19 delimits each side of the slit 17.
[0286]
[0190] In general, a widthwise distance between two delimiting lateral edges 19 of at least one of the one or more than one slit 17 varies in the lengthwise direction LD. Said widthwise distance contributes or defines the width profile of the spring section 8 of the main blade 1 . The lateral edge 19 may also be termed lateral inner edge to differentiate it from the lateral outermost edge 13 of (the spring section 8 of) the main blade 1 .
[0287]
[0191] The main blade 1 of FIG. 12 has a blade waist W1 of at a distance D1 from the front section 7, which blade waist W1 is nearer the front section 7 than the rear section 9. The cumulative width of the spring section 8 of this main blade 1 generally decreases from the rear section 6 towards the front section 9. Near the front section 9, the lateral outermost edge 13 forms a relatively small angle 0 to reduce local stress in the material of the main blade 1 .
[0288]
[0192] The spring section 8 of the main blade 1 (in this example and more generally) can be defined over the distance D3 which extends in the lengthwise direction LD between two innermost connection points, here embodied as connection holes 20, arranged in the main blade 1 of the front section 7 and the rear section 9, respectively. These connection holes 20 delimit the front, spring and rear sections 7, 8, 9, respectively. The holes 20 are termed connection holes here to distinguish these from any through holes or elongated slots 16 arranged in the spring section 8 of the main blade 1 to shape the cumulative width profile.
[0289]
[0193] Each lengthwise strip 18 of the illustrated main blade 1 comprises two connection holes 20 for coupling to the toe component 2. These connection holes 20 may, for each lengthwise strip 18, be spaced apart in the lengthwise direction LD. The rear section 9 of the illustrated main blade 1 has three connection holes 20 for coupling to the connection component 10. These three connection holes 20 are arranged in a triangle pattern: one connection hole 20 is arranged nearest the rear end 6 of the main blade 1 centrally in the widthwise direction WD while each of the remaining two connection holes 20 are arranged in the rear section 9 at a position which lies in an elongation of the lengthwise strip 18. As shown in the figures, bolts 21 are arranged through the connection holes 20 to couple the various components of the modular foot prosthesis system.
[0290]
[0194] FIG. 15 - 22 show various main blades 1 in plan view on their top surfaces 14. These may all have a constant thickness 1 , or at least a thickness tolerance and / or parallelism as indicated above. Other features can also conform to those explained for the main blade of FIG. 12 unless specifically indicated.
[0291]
[0195] FIG. 15 shows two options for a main blade 1 without a slit 17. The left-hand and right-hand options shows a lateral outermost edge 13 that is curved or straight, respectively. A curved or a straight lateral outermost edge 13 can be employed for both right and left lateral outermost edges 13 of the main blade 1 in a symmetric way. Alternatively, differently shaped right and left outermost edges 13 may also be used on the same main blade 1 , for example to incorporate specific spring action.
[0292]
[0196] FIG. 16 shows a main blade 1 similar to that of FIG. 12, though the lateral inner edges 19 delimiting the slit 17 are now curved rather than straight. In particular, the concavely curved as seen from a centreline through the slit 17.
[0293]
[0197] FIG. 17 shows a main blade 1 , again without a slit 17, but with two blade waists: a first blade waist W1 and a second blade waist W2. The first blade waist W1 is arranged nearer to the front section 7 or front end 5 of the main blade 1 , while the second blade waist W2 is arranged nearer to the rear section 9 or rear end 6 of the main blade 1 . As illustrated, the first blade waist W1 is arranged at a first distance D1 from the front section 7 (delimited from the spring section 8 by the innermost connection holes 20) and the second blade waist W2 is arranged at a second distance D2 from the front section 7. In this example, the distances D1 and D2 are both smaller than an overall length D3 of the spring section 8 and D1 is smaller than D2. The cumulative width profile between the first and second blades waists W1 , W2 may be increased relative to that at these blade waists, even up to a maximum width as illustrated.
[0294]
[0198] FIG. 18 shows a main blade 1 with two lengthwise strips 18, each of which has a different strip width profile along the lengthwise direction LD. The left-hand lengthwise strip 18 has a first strip waist W1 ’ which is nearer to the front section 7 (or front end 5) of the main blade 1 and which is also narrower than a second strip waist W2’ of the right-hand lengthwise strip 18. Similar to the blade waists W1 , W2, ... of the cumulative width profile of the main blade 1 , the strip waists W1 ’, W2’, ... are defined by a local minimum of the strip width profile of each lengthwise strip 18. When a main blade 1 has multiple lengthwise strips 18, variations in position as well as width of strip waists may generally be made to adjusting the spring action of the spring section 8. The different strip waists W1 ’ and W2’ in this example arise from shaping the two lateral inner edges 19 delimiting the slit 17 differently at each lengthwise strip 18. Each lateral inner edge 19 thus exhibits a different slope and / or curvature. The lateral outermost edges 13 in this example are symmetric, though these may also be varied to achieve the desired cumulative width profile.
[0295]
[0199] FIG. 19 shows a main blade 1 with three lengthwise strips 18 separated by two slits 17. This main blade 1 is symmetric along a central plane in the lengthwise direction LD. The left (e.g. first) and right (e.g. third) lengthwise strips 18 are symmetric while the middle (e.g. second) lengthwise strip 18 differs in that is has a different strip width profile along the lengthwise direction LD. The left and right lengthwise strips 18 each have a strip waist W1 ’ and W2’, respectively, nearer the front section 7 than a strip waist W3’ of the middle lengthwise strip 18. The third strip waist W3’ is also nearer to the rear section 9 than the front section 7 of the main blade 1 .
[0296]
[0200] FIG. 20 shows a main blade 1 with a through hole 16 in the spring section 8. One or more than one through hole 16 may (in part) define the cumulative width profile of the spring section in combination with any of the other features disclosed for this purpose. The cumulative width W3 at a particular position along the lengthwise direction W3 of this main blade 1 is composed of the widths W1 ’ and W2’ of each part of the spring section 8 adjacent to said through hole 16.
[0297]
[0201] FIG. 21 shows a main blade 1 with two through holes 16 arranged in the lengthwise direction LD of the main blade 1 . Alternatively or additionally, two or more through holes can also be arranged in the widthwise direction WD of the main blade 1 . The main blade 16 of this example also has two straight and parallel lateral outermost edges 13. The widthwise distance between a right lateral outermost edge 13 and a left lateral outermost edge 13 of the spring section 8 may thus be constant. However, the cumulative width profile thereof still varies along the lengthwise direction LD due to the through holes 16.
[0298]
[0202] FIG. 22 shows a main blade 1 in which cumulative width profile of the spring section 8 is defined by multiple features in combination: a varying overall width between the two lateral outermost edges 13 (here increasing from the rear section 9 towards the front section 7), the through hole 16 and the slit 1 with a varying slit width between its lateral inner edges 19. As illustrated, the cumulative width W4 at a particular position in the lengthwise direction LD is composed of the partial width W1 ’ between the left lateral outermost edge 13 and the through hole
[0299] 16, the partial width W2’ between the through hole 16 and the left lateral inner edge 19 of the slit
[0300] 17, and the partial width W3’ between the right lateral inner edge 19 of the slit 17 and the right lateral outermost edge 13.
[0301]
[0203] FIG. 23 - 27 show more details of the toe component 2 in multiple orthographic views. FIG.
[0302] 23 is a bottom view including the toe component 2 on the right and a similar toe component 2 on the left, which is mirror symmetric with the one on the right, and a connector 22 in between. FIG.
[0303] 24 is a front view onto the anterior end of the toe component 2 shown in the right of FIG. 23. FIG.
[0304] 25 is a side view onto the right face and FIG. 27 is a side view onto the left face as seen relative to the top view of FIG. 26 onto the top surface of the toe component 2.
[0305]
[0204] The modular foot prosthesis system can comprise a plurality of toe components. The optional connector 22 can then be arranged between a first toe component 2 and a second toe component 2 of the plurality of toe components 2. The connector 2 is configured to comply with or allow relative motion between the first and second toe components up to a predetermined distance between the first and second toe components and to transfer a pulling force from one of the first and second toe components to the other of the first and second toe components when the predetermined distance is reached. This function can be implemented in various ways.
[0306]
[0205] In the illustrated embodiment, the connector 22 couplable to the right (e.g. first) and the second (e.g. left) toe component 2 via elongated slots 23 defining the predetermined distance between the first and second toe components. The elongated slot 23 allows a certain amount of play between toe components 2 that are coupled with such connector 22. Though two elongated slots 22 are illustrated, both arranged in the connector 22, a single elongated slot 23 in either the connector 22 or the toe component 2 already suffices to enable the desired free motion over a limited range. A bolt, pin or other fastener can be arranged through the elongated slot 22.
[0307]
[0206] Alternatively or additionally, the connector 22 comprises or consists of a flexible band having a predetermined amount of slack between first and second toe components 2 to define said predetermined distance over which relative motion is enabled.
[0308]
[0207] The connector 22 can be arranged in corresponding recesses 24 at the bottom faces 25 of the respective first and second toe components 2. The toe component 2 may further comprise said bottom face 25 for supporting the user towards an external subsurface, even in the absence of said connector 22 or said recess 24. The bottom face in particular comprises a convexly curved outer surface 26, for example as illustrated.
[0309]
[0208] The first support surface 11 of the toe component 2 is arranged proximal to the user, in use, relative to the bottom face 25 of the toe component 2. In particular, the first support surface 11 is arranged at or in a top face 27 of the toe component 2 opposite the bottom face 25.
[0310]
[0209] Though the illustrated example has only two toe components 2, in general a plurality of toe components 2 can be provided, with each coupled or couplable to one of a plurality of lengthwise strips 18 of the main blade 2. Two toe components 2 are provided in the illustrated example, each of which is ranged to be coupled to one of the two lengthwise strips 18 of the main blade 1 illustrated in FIG. 1 - 14. This concept can be extended to a modular foot prosthesis system in which three or more toe components 2 and three or more lengthwise strips 18 are provided, wherein each toe component 2 is preferably coupled or couplable to at least one of the at least three lengthwise strips 18 of the main blade 1 . An example in which multiple (two) lengthwise strips 18 are provided and jointly couple to a single toe component 2, is shown in FIG. 43.
[0311]
[0210] In the example of FIG. 23 - 27 also used in FIG. 1 - 9, the first support surface 11 of the toe component 2 extends in a plane into a first recess 23 which is further formed by a first sidewall 24 extending transversely relative to the first support surface 11 . The plane of the first support surface 11 forms a bottom of said recess 23. The first sidewall 24 is configured to abut the front end 5 and / or at least one of the lateral outermost edges 13 of the main blade 1 and / or at least one of the lateral edges 19 of a lengthwise strip 18 comprised by the main blade 1 .
[0312]
[0211] The toe component 2 further comprises a first curved surface 30 arranged adjacent and posterior to the first support surface 11 . The first cured surface 25 serves to support a part of the spring section 8 that is adjacent to the front section 7 of the main blade 1 when the main blade 1 flexes towards the first support surface 11 . The first curved surface 25 curves away from a plane in which the first support surface 11 extends and, when the planar main blade 1 is coupled to the first support surface 11 , the first curved surface 30 thus curves away from the main blade 1 , as is particularly clear from the side view presented in FIG. 7.
[0313]
[0212] FIG. 28 shows an example of a releasable coupling 33 in an assembled modular foot prosthesis system comprising a main blade 1 and a toe component 2. The toe component 2 here comprises the first support surface 11 and the first curved surface 30. Further, a second support surface 31 and a second curved surface 32 are provided, which may form part of a clamping element 34 here illustrated in the form of a plate. Alternatively, the second support surface 31 and the second curved surface 32 may be comprised by the toe component 2. In any case, the second support surface 32 is optional, and when it is provided, the second curved surface 32 may or may not be used. FIG. 29 is a detailed view of a part of FIG. 28 comprising the second curved surface 32.
[0314]
[0213] The main blade 1 is coupled with its bottom surface 15 to the first support surface 11 of the toe component 2 by means of two bolts 21 arranged through connection holes 20 in the front section 7 of the main blade 1 . The clamping element 34 is arranged between heads of the bolts 21 and the top surface 14 of the main blade 1 .
[0315]
[0214] The main blade 1 may flex downwards, e.g. over an angle a, towards the first support surface 11 or the first curved surface 30 and may flex upwards, e.g. over an angle p, towards the second support surface 31 or the second curved surface 31 . As the main blade 1 flexes downwards or upwards, it is supported by the first and second curved surfaces 31 , 32.
[0316]
[0215] Preferably, the first curved surface 30 has a radius of curvature which decreases in a direction away from the first support surface 11 . As illustrated, the first curved surface 30 may exhibit a first radius of curvature R1 at or near the first support surface 11 which decreases to a second radius of curvature R2 along the extend of the first curved surface 30 further away from the first support surface 11 . The radius of curvature of the first curved surface 30 may be equal to that of the first support surface 11 where these surfaces meet.
[0317]
[0216] The second support surface 31 is arranged or arrangeable opposite the first support surface
[0318] 11 to hold the front section 7 of the main blade 1 between the first and second support surfaces 11 , 31 . The second support surface 31 may extend in a plane, for example as illustrated parallel to a plane in which the first support surface 11 extends. A distance between the first and second support surfaces 11 , 31 may correspond to the thickness of the front section 7 of the main blade 1 (e.g. the constant thickness of the whole main blade 1 in certain embodiments).
[0319]
[0217] The first and second support surfaces may be comprised by the toe component 2, for example by being integrally formed, to define a slotted recess in the toe component 2 for receiving the front section 7 of the blade 1 . Alternatively, the second support surface 31 and / or the second curved surface 32 may be comprises by a clamping element 34 separate from the toe component 2, for example as illustrated.
[0320]
[0218] The second curved surface 32 is arranged adjacent and posterior to the second support surface 31 to support a part of the spring section 8 adjacent to the front section 7 of the main blade 1 when flexed. This second curved surface 32 may be similar to the first curved surface 30. The second curved surface 32 may in particular have a radius of curvature which decreases in a direction away from the second support surface 31 or away from the top surface 14 of the planar main blade 1 illustrated in FIG. 28 - 29. In the illustrated example, the radius of curvature of the second curved surface 32 corresponds to that of the second support surface 31 where these surfaces meet.
[0321]
[0219] The example further illustrates that a support length of the first support surface 11 may differ from that of the second support surface 31 so that the main blade 1 , when coupled, is supported at opposite faces (i.e. its bottom and top surfaces) over a different lengthwise distance. In FIG. 28, three different support lengths are illustrated for the first support surface 11 , in which a length A1 - A3 as measured from the anterior end of the toe component 2 is indicated for each illustrated example. In example A1 , the support length of the first support surface 11 supporting the bottom surface 15 of the main blade 1 is shorter than that of the second support surface 31 supporting the top surface 14 of the main blade 1 . In example A2, the first support surface 31 extend beyond the second support surface 31 and the first curved surface 30 comprises radii of curvature R3 and R4 which may differ from those of the first curved surface 30 in example A1 . In example A3, the first support surface 31 extends even further. The first curved surface 30 and the second curved surface 32 may have the same or different curvature profiles.
[0322]
[0220] It is noted that the relative dimensions and curvatures in FIG. 28 - 29 are somewhat exaggerated for explaining the principles with more realistic proportions being illustrated in the other figures.
[0323]
[0221] FIG. 28 - 29 also show a damping element 35 arranged at the second curved surface 32. The damping element 35 is made of elastic material to dampen a flexing motion of the main blade 1 by contacting the main blade 1 when it flexes sufficiently. In general, the damping element 35 can be arranged at various location. It is preferred that the damping element 35 is arranged in such a way that flexing of the front end 5 the main blade 1 towards the user is damped.
[0324]
[0222] The damping element 35 is spaced from the top face of the main blade, when free from load, wherein the top face is proximal to the user at least at the position of the damping element.
[0325]
[0223] The damping element 35 may take the form of a layer to form a damping layer, e.g. on the first and / or second curved surfaces 30, 32 though it may also be arranged in a non-layer shape such as the one illustrated.
[0326]
[0224] In addition or as alternative to the damping element 35 at the second curved surface 32, a further damping element 35 can be arranged at the first curved surface 30 of the toe component 2, preferably in the form of a further damping layer.
[0327]
[0225] FIG. 30 shows an example of a toe component 2 with inserts 36. Each insert 36 may comprise an internal thread 37 for engaging a corresponding external thread of coupling device 21 , such as a bolt, to fix another component of the modular foot prosthesis system to the toe component 2. The illustrated example shows four holes or accommodations 50 distributed over two inserts 36. The accommodations 50 can be provided with internal thread 37 for engaging with a bolt 21 . A first insert 36 is provided with two accommodations 50 with internal thread 37 for alignment with the two connection holes 20 in the front section 7 of the main blade 1 (or at least one lengthwise strip 18 thereof), see arrows indicated with (a) and (b) in FIG. 30. Two bolts 21 can be used for fixing the front section 7 of the main blade 1 to the insert 37 and thereby to the toe component 2. This first insert 36 also comprises another accommodation with a third internal thread 37, indicated by arrow (c), to which the connector 22 can be coupled, e.g. as illustrated in FIG. 23. A second insert 36 is provided with an accommodation 50, indicated by arrow (d), for coupling to the heel blade 3 of the foot prosthesis. Though the first insert 36 is shown with three accommodations 50, each with an internal thread 37, separate inserts 36 can be used for each accommodation 50.
[0328]
[0226] The toe component 2 can be manufactured by positioning one or more than one insert 36 into a mould shaped to form the toe component. The mould is then filled with a mouldable material, such as fibre-reinforced resin, which is allowed to cure. The mould is then opened to remove the cured resin from the mould with the inserts embedded into the cured resin. Curing of the resin may involve application of appropriate pressure and / or temperature. The inserts 36 are preferably from a metal, such as titanium. The fibre-reinforced resin is preferably a forged composite or forged carbon.
[0329]
[0227] The heel component 4 may likewise be manufactured using inserts 36 for fixing (the rear section 9 of) the heel blade 3 to the heel component 4.
[0330]
[0228] FIG. 31 - 35 show an example of heel blade 3 in multiple orthographic views, of which FIG. 31 is a front view onto the front end 5 of the heel blade 3, FIG. 32 is a side view onto a first or right lateral outermost edge 13 thereof, FIG. 33 is a plan view onto the top or proximal surface 14 thereof, FIG. 34 is a side view onto a second or left later outermost edge 13 thereof, and FIG. 35 is a rear view onto the rear end 6 thereof.
[0331]
[0229] The heel blade 3 is made of a resilient material and extends in a lengthwise direction LD between a front end 5 and a rear end 6 of the heel blade 3. The heel blade 3 comprises, consecutively from the front end to the rear end: a front section 7 coupled or couplable to the toe component 2, a spring section 7 for providing spring action, and a rear section 9 coupled or couplable to an optional heel component 4. Explanations provided in the context of the main blade 1 equally apply to the heel blade 3, at least concerning the features with the same reference symbols.
[0332]
[0230] When a heel blade 3 is provided as part of the modular foot prosthesis system, it is preferred that the toe component 2 is configured to couple to said heel blade 3. In the illustrated examples (see in particular FIG. 23 - 27 and 30), the toe component 2 further comprises a third support surface 38 coupled or couplable to the front section 7 of the heel blade 3 to fix the front section 7 of the heel blade 3 to the toe component 2 and leave the remainder of the heel blade 3 freely suspended and unsupported for resilient flexing of the heel blade 3 relative to the toe component 2 when load is applied by the user.
[0333]
[0231] The third support surface 38 of this toe component 2 extends in a plane and is arranged at the bottom face 25 of the toe component 2. The third support surface 38 moreover extends into a second recess 39 of the toe component 2 which is further formed by a second sidewall 40 which extends transversely relative to the third support surface 38 and is configured to abut the front end 5 and / or at least one lateral edge 13 of the heel blade 3.
[0334]
[0232] Preferably, the toe component 2 further comprises a third curved surface 41 arranged adjacent and posterior to the third support surface 38 to support a part of the spring section 8 of the heel blade 3 that is adjacent to the front section 7 of the heel blade 3 when flexed.
[0335]
[0233] As is particularly clear from the side views in FIG. 25, 27 and 30 of the present example, the third support surface 38 of the toe component 2 is arranged below the first support surface 11 of the toe component 2 as seen in a vertical direction or in a proximal-to-distal direction in use of the foot prosthesis. The first support surface 11 of the toe component 2 extends beyond the third support surface 38 of the toe component 2 as seen in a posterior-to-anterior direction in use of the foot prosthesis. The front end 5 of the main blade 1 , when coupled to the toe component 2, then extends beyond the front end 5 of the heel blade 3 (again as seen in a posterior-to-anterior direction in use of the foot prosthesis).
[0336]
[0234] In designing the modular foot prosthesis system, various angles 5 can be selected between the main blade 1 and the heel blade 3 which are further explained with FIG. 44 - 49 below. At least in the case when planar main and heel blades 1 , 3 are used in conjunction with planer first and third support surfaces 11 , 38, the same angle 5 is formed between said blades and between said support surfaces.
[0337]
[0235] In the illustrated examples, the main blade 1 and the heel blade 3 are coupled only via the toe component 2. That is, no further load-bearing component is arranged to provide a mechanical connection between these blades. Further, the heel blade 3 is formed of a flat plate. The heel blade 3, or at least its spring section 7, is planar when free from load.
[0338]
[0236] Various features explained for (the spring section 7 of) the main blade 1 may likewise apply to corresponding features of (the spring section 7 of) the heel blade 3, even these may not all apply in the same embodiment of a modular foot prosthesis system. This relates for example to features regarding thickness, thickness tolerance and surface parallelism between top and bottom surfaces
[0339] 14, 15 of the heel blade 3, or at least the spring section 7 thereof.
[0340]
[0237] The spring section 7 of the heel blade 3 similarly has a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges 13 of the heel blade 3 measured in the widthwise direction WD. The cumulative width profile of the heel blade 3 may vary in the lengthwise direction LD of the heel blade 3, for example by at least 5% from a maximum cumulative width of the heel blade 3. What is explained for the cumulative width profile of the main blade 1 likewise applies to that of the heel blade 3, including its variations, curved or straight shaped lateral edges 13 and one or multiple blade waists.
[0341]
[0238] The illustrated example of a heel blade 3 in FIG. 33 shows a heel blade 2 having a cumulative width profile comprising a blade waist W5 defined by a local minimum of the cumulative width profile of the heel blade 3. The cumulative width profile of the heel blade 3 is here given by a width between two opposite lateral outermost edges 13 of the heel blade 3 but may also be defined by through holes 16, possibly elongated, and any slits 17 as explained for the main blade 1 .
[0239] The blade waist W5 of FIG. 33 is arranged at a distance D5 from the front section 7 of the heel blade 3. The length of the spring section 8 of the heel blade 3 is given by the distance D6, which here extends between two connection holes 20. One connection hole 20 is arranged in the front section 7 and the other is arranged in the rear section 9. Corresponding holes or accommodations can be arranged in the toe component 2 and heel component 4, respectively, for coupling the heel blade 2 to these components. The distance D5 is roughly half of the distance D6. In general, it is preferred to provide a blade waist at a position in the lengthwise direction LD of the heel blade 3 in the range of 20 to 80% of the total length of the heel blade 3 and / or in the range of 20 to 80% of the length D6 of the spring section 7 of the heel blade 3.
[0342]
[0240] Though only one blade waist W5 is shown, multiple blade waists can be provided in the heel blade 3, e.g. as illustrated and explained for the main blade 1 of FIG. 17.
[0343]
[0241] The example illustrated in FIG. 1 - 9 has two heel blades 3. In general, a plurality of heel blades 3 can be provided with each heel blade 3 coupled or couplable to at least one of a plurality of toe components 2 comprised by the foot prosthesis system. Further, one or more heel components 4 can be provided at respective rear ends 6 of the heel blades 3. Connection holes 20 are illustrated to couple the heel blades 3 to the toe components 2 and the heel components 4 by means of bolts 21 .
[0344]
[0242] Both main blades 1 and heel blades 3 can be manufactured by cutting a plate of resilient material into the shape of the desired blade. The plate of resilient material can be formed of or comprise a laminate. The laminate preferably comprising one or more than one composite layer, such as a fibre-reinforced resin, in particular comprising glass fibres and / or carbon fibres.
[0345]
[0243] FIG. 36 - 41 show an example of a heel component 4 in multiple orthographic views, of which FIG. 36 is a front view onto the anterior face of the heel component 4, FIG. 37 is a side view or lateral view onto a right face thereof, FIG. 38 is a plan view onto the top or proximal face 27 thereof, FIG. 39 is a side view onto a left face thereof, FIG. 40 is a rear view onto an posterior face thereof, and FIG. 41 is a bottom view onto the bottom or distal face 25 thereof.
[0346]
[0244] In the illustrated heel component 4, the support surface 12 extends in a plane. Said heel component 4 further comprises a curved surface 42 arranged adjacent and anterior to the support surface 12 of the heel component 4. The curved surface 42 serves to support a part of the spring section 7 of the heel blade 3 that is adjacent to the rear section 2 of the heel blade 3 when flexed. The curved surface 12 of the heel component 3 may have a radius of curvature which decreases in a direction away from the heel blade and / or away from the support surface of the heel component. Features of the curved surface 42 of the heel component 4 may correspond to those of the first, second and / or third curved surfaces 30, 32, 41 of the toe component 2.
[0347]
[0245] As is particularly clear in illustrated example of FIG. 7, the support surface 12 of the heel component 4 and the third support surface 38 of the toe component 2 may extend in parallel planes so that, when the heel blade 3 is coupled thereto and free from load, the heel blade 3 is supported roughly horizontal relative to a planar external subsurface or at least under an angle in the sagittal plane of less than 20°, preferably less than 10°, more preferably less than 3° or even parallel to said subsurface.
[0246] The heel component 4 of FIG. 36 - 41 comprises a bottom face 25 for supporting the user towards an external subsurface. The bottom face 25 comprises a convexly curved outer surface 26. The bottom face 25 also comprises a recess 43 with a slotted rim 44 for coupling replacement sole elements (not illustrated) into the heel component 4.
[0348]
[0247] The heel component 4 comprises a sidewall 45 extending transversely relative to the support surface 12 of the heel component 4 and configured to abut the rear end 6 and / or at least one lateral edge 13 of the heel blade 3. Said sidewall 45 may define, together with the support surface 12, a recess 46 in the heel component 4.
[0349]
[0248] The illustrated heel component 4 also comprises a protruding rim 47 which is configured to receive the rear end 6 of the main blade 1 when the main blade 1 and the heel blade 3 are flexed towards each other. This flexing motion brings the rear ends 6 of said blades together and the protruding rim 47 of the heel component 4 may come adjacent to, preferably even receive, the rear end 6 of the main blade 1 . This motion is indicated with the dashed arrow in FIG. 7. Such a configuration of the foot prosthesis can improve safety of the device during use. For example, objections can be prevented from getting trapped between main and heel blades 1 , 3 when the protruding rim 47 is provided.
[0350]
[0249] The heel component 4 can be manufactured in a way very similar to that of the toe component 2. Only a different mould should be used, namely a mould which conform to the desired shape of the heel component 4 as described herein.
[0351]
[0250] In the illustrated examples, the heel component 4 is only connected to the toe component 2 via the heel blade 3.
[0352]
[0251] The example of FIG. 1 - 9 shows two heel component 4, one of which is conform FIG. 36 - 41 and the other is a mirror image thereof, i.e. mirrored in a mirror plane that extends orthogonal and from top to bottom of the page. In general, a plurality of heel components 4 can be provided, each being coupled or couplable to at least one of a plurality of heel blades 3 comprised by the foot prosthesis system.
[0353]
[0252] FIG. 42 and 43 show exploded views of further modular foot prosthesis systems which include a toe cap 48 and a sole cap 49, each of which is optional.
[0354]
[0253] The toe cap 48 is coupled or couplable to the top face 27 of the toe component 2. The toe cap 48 is preferably configured to cover the first support surface 11 of the toe component 2 and / or at least a part of the front section 7 of the main blade 1 when coupled to the first support surface
[0355] 11 . In the illustrated examples, the toe cap 48 covers a releasable coupling 33, here implemented as bolts 21 , used for coupling the front section 7 of the main blade 1 to the toe component 2.
[0356]
[0254] The sole cap 49 is coupled or couplable to the bottom face 25 of the toe component 2. The sole cap 49 is preferably configured to cover the third support surface 38 of the toe component 2 and / or at least a part of the front section 7 of the heel blade 3 when coupled to the third support surface 38. In the illustrated examples, the sole cap 49 covers a releasable coupling 33, here implemented as bolts 21 , used for coupling the front section 7 of the heel blade 3 to the toe component 2.
[0255] The toe cap 48 and the sole cap 49 can be coupled to the toe component 2 by a single releasable coupling, illustrated as bolts 21 which pass through a connection hole 20 in the toe component 2 along the dashed lines.
[0357]
[0256] The example of FIG. 42 has two toe caps 48, corresponding to the two toe elements 2 which in turn are configured to be coupled to one of the two lengthwise strips 18 formed in the main blade 1 . This example further has two heel blades 3, each of which is coupled to one toe component 2 at its front end 5 and to one heel component 4 at its rear end 6. The foot prosthesis formed by assembling the components of FIG. 24 is split into two halves starting from the spring section 8 of the main blade 1 , through the two toe components 2, the two heel blades 3 and the two heel components 4. The set of toe and sole caps 48, 49 is configured likewise. The example of FIG. 43 shows a variation in which only the main blade 3 is split but the toe component 2, the heel blade 3 and the heel component 4 are each in one piece. Combinations of components from the example in FIG. 42 with components of FIG. 43 are also envisaged. For example, the heel blades 3 and the heel components 4 of FIG. 42 can be employed with the toe component 2 of FIG. 43.
[0358]
[0257] In both illustrated examples, a bolt 21 is used to couple both the sole cap 49 and the toe cap
[0359] 48 to the toe component 2 along the dashed lines. At least one accommodation or through hole 50 is provided in the toe component 2 for this end. The through hole 50 may have a shape corresponding with a protrusion 56 on the sole cap 49 and / or the toe cap 48. Further, the sole cap
[0360] 49 and the toe cap 48 may each comprises a hole 57 for receiving the bolt 21 . In the illustrated example, the toe cap 48 has a blind hole 57 and the sole cap 49 has a recessed hole 56 to receive the head of the bolt 21 . The arrangement of the accommodation or through hole 50 on the toe component 2 and the corresponding protrusion 56 on the toe cap 48 and / or the sole cap 49 may be interchanged, in that the toe component 2 comprises a protrusion corresponding to an accommodation in the toe cap 48 and / or the sole cap 49. Accommodation 50 and protrusion 56 may slot into each other when the foot prosthesis is assembled. In general, any releasably connection 33 may be employed here, for example such as explained herein for coupling the blades.
[0361]
[0258] As is particularly clear from the exploded views of FIG. 3, 4, 42 and 43, the foot prosthesis system can be modularly assembled from the various component. To this end, the modular foot prosthesis system may further comprise one or more than one releasable coupling 33 arranged to releasably couple at least two components of the foot prosthesis system.
[0362]
[0259] For example, at least one of the following may be included. A first releasable coupling 33 can be arranged to releasably couple the front section 7 of the main blade 1 to the first support surface 11 of the toe component 2. A second releasable coupling 33 can be arranged to releasably couple the front section 7 of the main blade 3 to the second support surface 31 of the toe component. The first and second releasable couplings 33 may form a single coupling, e.g. involving a slotted recess are a bolt 21 passing through first and second support surfaces 11 , 31 with the main blade 1 in between. A third releasable coupling 33 can be arranged to releasably couple the front section 7 of the heel blade 3 to the third support surface 33 of the toe component 2. A fourth releasable coupling 33 can be arranged to releasably couple the rear section 9 of the heel blade 3 to the support surface 12 of the heel component 4. A fifth releasable coupling 33 can be arranged to releasably couple the rear section 9 of the main blade 1 to the connection component 10.
[0363]
[0260] One or more than one of these releasable couplings 33 can involve a clamp, a slot and pin connection, a biased locking lip connection or a bolt connection. The illustrated examples use bolts 21 , though any other suitable releasable coupling may in principle be employed.
[0364]
[0261] In the figures, a first connection hole 20 is arranged in the front section 7 of the main blade 1 and a second connection hole or accommodation 50 is correspondingly arranged in the first support surface 11 of the toe component 2 to releasably couple the main blade 1 to the toe component 2 with a first pin or bolt 21 arranged through the first and second holes 20, 50. Further, a third hole 20 is arranged in the front section 7 of the heel blade 3 and fourth hole or accommodation 50 is correspondingly arranged in the third support surface 38 of the toe component 2 to releasably couple the heel blade 3 to the toe component 2 with a second pin or bolt 21 arranged through the third and fourth holes 20, 50. Further, a fifth hole 20 is arranged in the rear section 9 of the main blade 1 for aligning with a sixth hole or accommodation 50 correspondingly arranged in the connection component 10 to releasably couple the main blade 1 to the connection component 10 with a third pin or bolt 21 arranged through the fifth and sixth holes 20, 50.
[0365]
[0262] FIG. 44 - 49 show various configurations of modular foot prosthesis systems with an optional connection component 10 and / or an optional auxiliary blade 51 . In each of the illustrated configurations, the main blade 1 is only directly supported by the toe component 2 and is unsupported in the modular foot prosthesis system at the rear section 9 and also unsupported over at least a part of the spring section 8 that is adjacent to the rear section 9. Preferably, most of the spring section 8 is unsupported. The illustrated modular foot prosthesis systems are configured to transfer a load exerted on the rear section 9 of the main blade 1 to the toe component 2 mitigated only be the spring action of the spring section 8.
[0366]
[0263] In the illustrated examples, the anterior end of the foot prosthesis is directed to the right of the page in its landscape reading orientation, while the posterior end is directed to the left. Distal is downwards and proximal is upwards on the page. The plane of the page is parallel to the sagittal plane.
[0367]
[0264] The foot prostheses can each be connected to or towards the body, in particular a lower extremity, of the user at the proximal end, for example via the connection component 10. A pyramidal coupling 52 or other arrangement known in the field of foot prosthetic devices can be provided to mechanically couple the foot prosthesis to a stump or wearable connector of the user. In more advanced embodiments, the connection component 10 can also comprise a joint, such as a prosthetic ankle joint.
[0368]
[0265] The connection component 10 is coupled or couplable to the rear section 9 of the main blade 1 . In the illustrated examples, the connection component 10 is only connected to the toe component 2 via the main blade 1 . In other words, the connection component 10 is not directly coupled to the toe component 2. Further, it is preferred that the connection component 10 is not directly coupled to the heel blade 3 (when present) or the heel component 4 (when present).
[0266] The auxiliary blade 51 extends in a lengthwise direction LD between a front end 5 and a rear end 6 of the auxiliary blade, wherein the auxiliary blade comprises, consecutively from the front end 5 to the rear end 6: a front section 7 coupled or couplable to the connection component 10, a spring section 8 for providing spring action, and a rear section 9 for coupling to an auxiliary connection component 54 proximal to the user. The spring section 8 is optional and the auxiliary blade 51 need not be made of a resilient material, though this is possible. However, the auxiliary blade 51 may share features of the main blade 1 . In particular, the auxiliary blade 51 can be formed of flat plate and / or be planar when free from load. When the auxiliary blade 51 comprises the spring section 8, it is preferred that at least this spring section 8, when free from load, is planar. (In the illustrated configurations, all blades are planar.) Further, the auxiliary blade 51 , in particular the spring section 8 of the auxiliary blade 51 , can comprise a cumulative width profile defined as a cumulative width of (resilient) material present between opposite lateral outermost edges 13 of the auxiliary blade 51 measured in the widthwise direction WD. This cumulative width profile may exhibit a variation of at least 5% from a maximum cumulative width of the auxiliary blade 51 and / or may exhibit one or more than one blade waist which is at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile of the auxiliary blade 51 .
[0369]
[0267] The example of FIG. 44 may conform to that of FIG. 1 - 9 with the addition of a connection component 10. The connection component 10 may here serve to connect the foot prosthesis towards the user by means of the pyramidal coupling 52.
[0370]
[0268] FIG. 45 shows a relatively low configuration with the connection component 10 defining an acute angle y between the main blade 1 and the auxiliary blade 51 . The auxiliary blade 51 carries a pyramidal coupling 52 for connecting the foot prosthesis to the user, which in this example may involve a relatively low stump (e.g. at the natural ankle of the user).
[0371]
[0269] In general, the main blade 1 and the auxiliary blade 3 are coupled or couplable to the connection component under an angle y measured in the sagittal plane, and measured when these blades are free from load, that is at least 10°, preferably in the range of 10 to 170°, more preferably in the range of 10 to 80°.
[0372]
[0270] The angle 6 between the main blade 1 and the heel blade 3 is also measured in the sagittal plane in the situation where these blades are free from load. It is preferred that the angle 5 is in the range of 10 to 80°, more preferably 20 to 70°. The same angle 6 may apply between the first support surface 11 and third support surface 38 of the toe component 2, also measured in the sagittal plane.
[0373]
[0271] In the example of FIG. 45, the angles 5 and y are similar or even equal so that an overall Z- shape configuration of the heel blade 3, main blade 1 and auxiliary blade is obtained. More generally, the heel blade 3 and the auxiliary blade 51 may be parallel in the sagittal plane.
[0374]
[0272] FIG. 46 shows a configuration without heel blade 3 (and without heel component 4) to illustrate that heel blades 3 are optional. Further the heel component 4, in combination with the heel blade 3, is optional. A foot prosthesis can also be provided without the specific heel blade 3 as disclosed herein but with the heel component 4, for example by having the heel component 4 integrated with the toe component 2 without a heel blade 3 between toe and heel components. The main blade 1 is coupled to an auxiliary blade 51 by means of the connection component 10 under the angle y. The auxiliary blade 51 supports to user so that the foot prosthesis is balanced in use, for example in ways similar to known running blades. Note however, that this example differs from such known running blades at least in the features that the main blade 1 is formed of a plate and is planar, which main blade 1 is further releasably coupled to the toe component 2 by means of a releasable coupling 33 which here involves bolts 21 .
[0375]
[0273] FIG. 47 shows a variation of the configuration of FIG. 44 in which the main blade 1 extends beyond the posterior end of the heel component 4. Further, the connection component 10 here supports an auxiliary blade 51 to which a further or auxiliary connection component 54 is arranged, which in turn supports a pyramidal coupling 52. The configuration of FIG. 47 may be advantageous when the foot prosthesis is to be coupled to a posterior side of the stump of the user, rather than a lower or distal end.
[0376]
[0274] The auxiliary connection component 54 may have the same features as the connection component 10 but it may also differ depending on the intended use. The auxiliary connection component 54 may in general comprise a joint, such as a prosthetic ankle joint or a prosthetic knee joint. The auxiliary connector component 54 is coupled or couplable to the rear section 9 of the auxiliary blade 51 .
[0377]
[0275] FIG. 48 and 49 show two further variations on the configuration of FIG. 47. In FIG. 48, the auxiliary blade 51 supports an upright blade or post 55. The upright post 55 can be coupled to the stump of a user. In FIG. 49, the auxiliary connection component 54 is arranged at the same side of the auxiliary blade 51 as the connection component 10 and supports the pyramidal coupling 52 from below. Here, the pyramidal coupling 52 can engage a corresponding part worn by the user at his or her distal or lower end.
[0378]
[0276] As the main blade 1 of the configurations of FIG. 47 - 49 is relatively long, an overall higher construction of the foot prosthesis is achieved and a larger amplitude for spring action can be achieved this main blade 1 . Further, the heel blade 3 can likewise be adapted or replaced to provide foot prostheses of various overall dimensions while the toe component 2 and the heel component 4 can be the same.
[0379]
[0277] An existing foot prosthesis can thus be adapted readily by replacing one or more than one of the blades 1 , 3, 54, 55 or by adjusting the width profile thereof. In particular, the cumulative width profile of the spring section 8 of the main blade 1 can be adapted by taking away material from an existing main blade 1 or by replacing the main blade 1 altogether. The same can be done with the heel blade 3.
[0380]
[0278] FIG. 50 - 53 show another example of a modular foot prosthesis system which is generally comparable to that of FIG. 1 - 2 and has one main blade 1 , two toe components 2 and two heel blades 3. Each of these may have the features as disclosed herein in relation to the main blade 1 , the toe component 2 and the heel blade 3, respectively. As explained above, the heel blade 3 is optional in all embodiments and may thus also be omitted in this example. A heel component 4 may also be provided in this example, though it is not illustrated.
[0279] In FIG. 50 and 51 , the modular foot prosthesis system is shown under skew angles from above and below, respectively, in an assembled state. Connection means, such as pins or bolts 21 , to fasten the main blade 1 and the heel blades 3 to the two toe components 2 are omitted for clarity. Exploded views of the same example are shown in FIG. 52 and 52 from above and below, respectively.
[0381]
[0280] In this example, a top support blade 58 is provided on the main blade 1 , in particular on the top surface 14 of the main blade 1 . The top surface 14 of the main blade 1 faces towards the user in normal use of the foot prosthesis system. The top support blade 58 here extends from the rear section 9 of the main blade 1 over a part of the spring section 8 of the main blade 1 and preferably clears the front section 7 of the main blade 1 . The top support blade 58 may in particular be connected to the main blade 1 at the rear section 9 (e.g. by means of a pin or bolt 21 arranged through mutually overlapping holes 20) while being left freely suspended over the spring section 8.
[0382]
[0281] The top support blade 58 may be planar and / or flat just like the main blade 1 . Further, the top support blade 58 may have a contour corresponding to that of the main blade 1 . Preferably, the top support blade 58 extends (from the rear section 9) over only a portion of the distance D3 between the front and rear sections 7, 9 of the main blade 1 .
[0383]
[0282] Further, a bottom support blade 59 is provided. The bottom support blade 59 may be similar to the top support blade 59, except that it is arranged and shaped differently. The bottom support blade 59 is provided on the main blade 1 , in particular on the bottom surface 15 of the main blade 1 . The bottom surface 15 of the main blade 1 faces away from the user in normal use of the foot prosthesis system and / or towards the toe component 2. The bottom support blade 59 here extends from the front section 7 of the main blade 1 over a part of the spring section 8 of the main blade 1 and preferably clears the rear section 9 of the main blade 1 . The bottom support blade 59 may in particular be connected to the main blade 1 at the front section 7 and to the toe component 2 (e.g. by means of a pin or bolt 21 arranged through mutually overlapping holes 20) while being left freely suspended over the spring section 8.
[0384]
[0283] The bottom support blade 59 may also be planar and / or flat and may further have a contour corresponding to that of the main blade 1 . Preferably, the bottom support blade 59 extends (from the front section 7) over only a portion of the distance D3 between the front and rear sections 7, 9 of the main blade 1 .
[0385]
[0284] When the main blade 1 comprises a slit 17 forming multiple lengthwise strips 18 towards the front end 5 of the main blade 1 , multiple bottom support blades 59 may be provided, e.g. one bottom support blade 59 for each lengthwise strip 18. In the illustrated example, the main blade 1 comprises one slit 17 and two lengthwise strips 18, each provided with a bottom support blade 59.
[0386]
[0285] Though it may be preferred to include both the top support blade 58 as well as the bottom support blade 59, each of these may be employed without the other. When both top and bottom support blades 58, 59 are provided, it is preferred that these partially overlap along the spring section 8 of the main blade 1 (as seen in plan view). This is also visible in the illustrated example. The top support blade 58 may be arranged between the main blade 1 and the connection component 10 while the bottom support blade 59 may be arranged between the main blade 1 and the toe component 2.
[0387]
[0286] The top and bottom support blades 58, 59 aid in spring action of the foot prosthesis system, in particular its main blade 1 , during perambulation of the user. The top support blade 58 stiffens the foot prosthesis when the toe component 2 moves upwards during use by engaging the spring section 7 of the main blade 1 towards the rear section 9 of the main blade 1 . The bottom support blade 59 stiffens the foot prosthesis when the user (or a connection component 10) moves downwards towards the (optional) heel blade 3 and / or heel component 4 during use by engaging the spring section 7 of the main blade 1 towards the front section 7 of the main blade 1 . As the top and bottom support blades 58, 59 are separate and distinct from the main blade 1 , these only come into action when the main blade 1 moves or springs upwards or downwards, respectively.
[0388]
[0287] Slide layers 60, 61 may be interposed between the main blade 1 and the top and / or bottom support blades 58, 59. In the illustrated example, a top slide layer 60 is arranged between the main blade 1 and the top support blade 58. The top slide layer 60 may be fastened at the rear section 9 of the main blade 1 . Further, a bottom slide layer 61 may be arranged between the main blade 1 and the bottom support blade 59. The bottom slide layer 61 may be fastened at the front section 7 of the main blade 1 . An outer contour of the respective slide layers 60, 61 may correspond to that of the top and bottom support blade 58, 59.
[0389]
[0288] The slide layers 60, 61 may be flat and planar, for example by cutting these from a flat plate of a certain material. The slide layers 60, 61 can be produced from low friction materials such as polytetrafluoroethylene. The top and bottom support blades 58, 59 can be produced from the same materials as the main blade 1 but may also be produced from other, resilient and strong materials such as metals.
[0390]
[0289] The respective slide layers 60, 61 reduce damaging frictional effects between the respective support blades 58, 59 as the main blade 1 flexes upwards or downwards. Longevity of the foot prosthesis system can thus be improved.
[0391]
[0290] Though the above describes the invention in the context of a foot prosthesis, the technology as disclosed herein can also be applied more generally to a lower-extremity prothesis (also termed lower limb prosthesis). The disclosure thus also relates to a lower-extremity prothesis comprising features disclosed herein as part of the foot prothesis. In particular, a lower-extremity prothesis is provided which comprises at least one of the modular foot prosthesis system according to the first aspect, the main blade according to the second aspect, the toe component according to the third aspect, the heel blade according to the fourth aspect, and the heel component according to the fifth aspect. Any one or a combination of these first to fifth aspects can be used for such a lower- extremity prothesis. The lower-extremity prothesis may, in addition to at least one component as disclosed herein, also include known components or parts.
Claims
CLAIMS1 . A modular foot prosthesis system comprising:- a main blade of a resilient material extending in a lengthwise direction between a front end and a rear end of the main blade, wherein the main blade comprises, consecutively from the front end to the rear end:- a front section which, in use, is distal from a user of the foot prosthesis system;- a spring section for providing spring action; and- a rear section coupled or couplable to a connection component which, in use, is proximal to the user; and- a toe component forming an anterior aspect of a foot prosthesis and configured to support the main blade, wherein the toe component comprises:- a first support surface coupled or couplable to the front section of the main blade to fix the front section of the main blade to the toe component and leave the remainder of the main blade freely suspended and unsupported for resilient flexing of the main blade relative to the toe component when load is applied by the user.
2. The modular foot prosthesis system according to claim 1 , wherein the main blade is unsupported in the modular foot prosthesis system at the rear section and at least a part of, preferably most of, the spring section adjacent to the rear section.
3. The modular foot prosthesis system according to claim 1 or 2, configured to transfer a load exerted on the rear section of the main blade to the toe component mitigated only be the spring action of the spring section.
4. The modular foot prosthesis system according to any one of the previous claims, wherein the main blade or at least its spring section is formed of a flat plate.
5. The modular foot prosthesis system according to any one of the previous claims, wherein the main blade or at least its spring section, when free from load, is planar.
6. The modular foot prosthesis system according to any one of the previous claims, wherein the main blade or at least its spring section has a thickness measured perpendicular to both the lengthwise direction and a widthwise direction with a thickness tolerance of less than 2 mm, preferably less than 1 mm, more preferably less than 0.5 mm.
7. The modular foot prosthesis system according to any one of the previous claims, wherein the main blade or at least its spring section has a top surface and a bottom surface with a surface parallelism when free from load of less than 3 mm over 100 mm, preferably less than 2 mm over 100 mm, more preferably less than 1 mm over 100 mm.
8. The modular foot prosthesis system according to any one of the previous claims, wherein the spring section of the main blade has a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the main blade measured in the widthwise direction, wherein the cumulative width profile varies in the lengthwise direction.
9. The modular foot prosthesis system according to claim 8, wherein the cumulative width profile comprises a variation of at least 5% from a maximum cumulative width.
10. The modular foot prosthesis system according to claim 8 or 9, wherein the cumulative width profile comprises one or more than one blade waist defined by a local minimum of the cumulative width profile.11 . The modular foot prosthesis system according to claim 10, wherein at least one of the one or more than one blade waist is at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile.
12. The modular foot prosthesis system according to claim 10 or 11 , wherein a first blade waist of the one or more than one blade waist is arranged closer to the front section of the main blade than to the rear section of the main blade.
13. The modular foot prosthesis system according to claim 10, 11 or 12, wherein a second blade waist of the one or more than one blade waist is arranged closer to the rear section of the main blade than to the front section of the main blade.
14. The modular foot prosthesis system according to any one of the previous claims, wherein a widthwise distance between a right lateral outermost edge and a left lateral outermost edge of the spring section varies in the lengthwise direction.
15. The modular foot prosthesis system according to any one of the previous claims, wherein the right lateral outermost edge and the left lateral outermost edge of the spring section are asymmetric relative to the lengthwise direction.
16. The modular foot prosthesis system according to any one of the previous claims, wherein the spring section of the main blade comprises one or more than one through hole.
17. The modular foot prosthesis system according to claim 16, wherein the one or more than one through hole comprises an elongated slot extending in the lengthwise direction over at least a part of the spring section.
18. The modular foot prosthesis system according to any one of the previous claims, wherein the main blade comprises one or more than one slit separating the front section and at least a part, preferably most, of the spring section adjacent to the front section into a plurality of lengthwise strips.
19. The modular foot prosthesis system according to claim 18, wherein each of the plurality of lengthwise strips has a strip width profile defined as a width of resilient material present between opposite lateral edges of the respective lengthwise strip, wherein the plurality of strip width profiles jointly defines the cumulative width profile of the spring section.
20. The modular foot prosthesis system according to claim 19, wherein at least one of the strip width profiles of the plurality of lengthwise strips varies in the lengthwise direction.21 . The modular foot prosthesis system according to any one of the claims 18 to 20, wherein a first lengthwise strip of the plurality of lengthwise strips comprises a first strip waist defined by a local minimum of the strip width profile of the first lengthwise strip.
22. The modular foot prosthesis system according to claim 21 , wherein a second lengthwise strip of the plurality of lengthwise strips comprises a second strip waist defined by a local minimum of the width profile of the second lengthwise strip, wherein the first strip waist and the second strip waist differ with respect to at least one of:- a strip width at the respective strip waist; and- a distance of the respective strip waist relative to the front end of the main blade.
23. The modular foot prosthesis system according to any one of the claims 18 to 22, wherein a widthwise distance between a right lateral edge and a left lateral edge of at least one of the plurality of lengthwise strips varies in the lengthwise direction.
24. The modular foot prosthesis system according to claim 23, wherein the right lateral edge and the left lateral edge of said lengthwise strip have a different slope and / or curvature in the lengthwise direction.
25. The modular foot prosthesis system according to any one of the claims 18 to 24, wherein a widthwise distance between two delimiting lateral edges of at least one of the one or more than one slit varies in the lengthwise direction.
26. The modular foot prosthesis system according to any one of the claims 18 to 25, wherein two delimiting lateral edges of a slit among the one or more than one slit have a different slope and / or curvature in the lengthwise direction.
27. The modular foot prosthesis system according to any one of the claims 18 to 26, wherein the one or more than one slit comprises two slits separating the main blade into at least three lengthwise strips.
28. The modular foot prosthesis system according to any one of the claims 18 to 27, wherein the plurality of lengthwise strips comprises three lengthwise strips: a first lengthwise strip, a second lengthwise strip and a third lengthwise strip, wherein the second lengthwise strip is arranged between the first and third lengthwise strips as seen in the widthwise direction.
29. The modular foot prosthesis system according to claim 28, wherein the first and third lengthwise strips have a strip width profile different from that of the second lengthwise strip, in particular a strip waist of the first and third lengthwise strips being nearer to the front section of the main blade than a strip waist of the second lengthwise strip and preferably also being nearer to the front section than to the rear section of the main blade.
30. The modular foot prosthesis system according to any one of the claims 8 to 29, wherein the cumulative width profile comprises a decrease of cumulative width along at least a part of the spring section as seen in the lengthwise direction from the rear section to the front section of the main blade.31 . The modular foot prosthesis system according to any one of the previous claims, wherein the first support surface of the toe component extends into a first recess which is further formed by a first sidewall extending transversely relative to the first support surface and configured to abut the front end and / or at least one of the lateral edges of the main blade.
32. The modular foot prosthesis system according to any one of the previous claims, wherein the first support surface of the toe component extends in a plane.
33. The modular foot prosthesis system according to any one of the previous claims, wherein the toe component further comprises a first curved surface arranged adjacent and posterior to the first support surface to support a part of the spring section adjacent to the front section of the main blade when flexed.
34. The modular foot prosthesis system according to claim 33, wherein the first curved surface has a radius of curvature which decreases in a direction away from the first support surface.
35. The modular foot prosthesis system according to claim 33 or 34, wherein the radius of curvature of the first curved surface corresponds to that of the first support surface at the interface between the first curved surface and the first support surface.
36. The modular foot prosthesis system according to any one of the previous claims, further comprising a second support surface arranged or arrangeable opposite the first support surface to hold the front section of the main blade between the first and second support surfaces.
37. The modular foot prosthesis system according to claim 36, wherein the second support surface extends in a plane, preferably parallel to a plane in which the first support surface extends.
38. The modular foot prosthesis system according to claim 36 or 37, wherein the first and second support surfaces define a slotted recess in the toe component to receive the front section of the main blade.
39. The modular foot prosthesis system according to any one of the claims 36 to 38, wherein the second support surface forms part of a clamping element which is separate from the toe component.
40. The modular foot prosthesis system according to any one of the claims 36 to 39, wherein a second curved surface is arranged adjacent and posterior to the second support surface to support a part of the spring section adjacent to the front section of the main blade when flexed.41 . The modular foot prosthesis system according to claim 40, wherein the second curved surface has a radius of curvature which decreases in a direction away from the second support surface.
42. The modular foot prosthesis system according to claim 40 or 41 , wherein the radius of curvature of the second curved surface corresponds to that of the second support surface at the interface between the second curved surface and the second support surface.
43. The modular foot prosthesis system according to any one of the claims 36 to 42, wherein a support length of the first support surface differs from that of the second support surface so that the main blade, when coupled, is supported at opposite faces over a different lengthwise distance.
44. The modular foot prosthesis system according to any one of the previous claims at least dependent on claims 33 and 40, wherein the first curved surface and the second curved surface have different curvature profiles.
45. The modular foot prosthesis system according to any one of the previous claims, further comprising a damping element of elastic material arranged to dampen a flexing motion of the front end of the main blade towards the user.
46. The modular foot prosthesis system according to claim 45, wherein the damping element is spaced from the top surface of the main blade, when free from load, wherein the top surface is proximal to the user at least at the position of the damping element.
47. The modular foot prosthesis system according to claim 45 or 46 at least dependent on claim 40, wherein the damping element is arranged at the second curved surface of the toe component, preferably in the form of a damping layer.
48. The modular foot prosthesis system according to claim 47, wherein a further damping element is arranged at the first curved surface of the toe component, preferably in the form of a further damping layer.
49. The modular foot prosthesis system according to any one of the previous claims, wherein the toe component further comprises a bottom face for supporting the user towards an external subsurface.
50. The modular foot prosthesis system according to claim 49, wherein the bottom face comprises a convexly curved outer surface.51 . The modular foot prosthesis system according to claim 49 or 50, wherein the first support surface is arranged proximal to the user, in use, relative to the bottom face.
52. The modular foot prosthesis system according to any one of the claims 49 to 51 , wherein the first support surface of the toe component is arranged at or in a top face of the toe component opposite the bottom face of the toe component.
53. The modular foot prosthesis system according to any one of the previous claims at least dependent on claim 18, wherein a plurality of toe components is provided, each coupled or couplable to one of the plurality of lengthwise strips of the main blade.
54. The modular foot prosthesis system according to claim 53, wherein at least three toe components and at least three lengthwise strips are provided, wherein each toe component is coupled or couplable to at least one of the at least three lengthwise strips of the main blade.
55. The modular foot prosthesis system according to claim 53 or 54, wherein a connector is arranged between a first toe component and a second toe component of the plurality of toe components, wherein the connector is configured to comply with relative motion between the first and second toe component up to a predetermined distance between first and second toe components and transfer a pulling force from one of the first and second toe components to the other of the first and second toe components when the predetermined distance is reached.
56. The modular foot prosthesis system according to claim 55, wherein the connector is coupled to the first and / or second toe component via at least one elongated slot defining the predetermined distance between the first and second toe components.
57. The modular foot prosthesis system according to claim 55 or 56, wherein the connector comprises a flexible band having a predetermined amount of slack between first and second toe components to define the predetermined distance between the first and second toe components.
58. The modular foot prosthesis system according to any one of the claims 55 to 57, wherein the connector is arranged in recesses at the bottom faces of the respective first and second toe components.
59. The modular foot prosthesis system according to any one of the previous claims, further comprising a toe cap coupled or couplable to a top face of the toe component, wherein the toe cap is configured to cover the first support surface and at least a part of the front section of the main blade when coupled to the first support surface.
60. The modular foot prosthesis system according to any one of the previous claims, further comprising a sole cap coupled or couplable to a bottom face of the toe component, wherein the sole cap is configured to cover the third support surface of the toe component and at least a part of the front section of the heel blade when coupled to the third support surface.61 . The modular foot prosthesis system according to any one of the previous claims, further comprising:- a heel blade of a resilient material extending in a lengthwise direction between a front end and a rear end of the heel blade, wherein the heel blade comprises, consecutively from the front end to the rear end:- a front section coupled or couplable to the toe component;- a spring section for providing spring action; and- a rear section coupled or couplable to a heel component.
62. The modular foot prosthesis system according to claim 61 , wherein the toe component further comprises a third support surface coupled or couplable to the front section of the heel blade to fix the front section of the heel blade to the toe component and leave the remainder of the heel blade freely suspended and unsupported for resilient flexing of the heel blade relative to the toe component when load is applied by the user.
63. The modular foot prosthesis system according to claim 62, wherein the third support surface of the toe component extends in a plane.
64. The modular foot prosthesis system according to claim 62 or 63, wherein the third support surface of the toe component extends into a second recess which is further formed by a second sidewall extending transversely relative to the third support surface and configured to abut the front end and / or at least one lateral edge of the heel blade.
65. The modular foot prosthesis system according to any one of the claims 62 to 64, wherein the toe component further comprises a third curved surface arranged adjacent and posterior to the third support surface to support a part of the spring section of the heel blade adjacent to the front section of the heel blade when flexed.
66. The modular foot prosthesis system according to any one of the claims 62 to 65, wherein the third support surface of the toe component is arranged below the first support surface of the toe component as seen in a proximal-to-distal direction in use of the foot prosthesis system.
67. The modular foot prosthesis system according to any one of the claims 62 to 66, wherein the first support surface of the toe component extends beyond the third support surface of the toe component as seen in a posterior-to-anterior direction in use of the foot prosthesis system.
68. The modular foot prosthesis system according to any one of the claims 61 to 67, wherein the front end of the main blade extends beyond the front end of the heel blade as seen in a posterior-to-anterior direction in use of the foot prosthesis system.
69. The modular foot prosthesis system according to any one of the claims 62 to 68, wherein an angle between the first and third support surfaces of the toe component measured in the sagittal plane and when free from load is in the range of 10 to 80°, preferably 20 to 70°, more preferably 20 to 30°.
70. The modular foot prosthesis system according to any one of the claims 61 to 69, wherein an angle between the main blade and the heel blade measured in the sagittal plane and when free from load is in the range of 10 to 80°, preferably 20 to 70°.71 . The modular foot prosthesis system according to any one of the claims 61 to 70, wherein the main blade and the heel blade are coupled only via the toe component.
72. The modular foot prosthesis system according to any one of the claims 61 to 71 , wherein the heel blade is formed of a flat plate.
73. The modular foot prosthesis system according to any one of the claims 61 to 72, wherein the heel blade or at least its spring section, when free from load, is planar.
74. The modular foot prosthesis system according to any one of the claims 61 to 73, wherein the heel blade or at least its spring section has a thickness measured perpendicular to both the lengthwise direction and a widthwise direction with a thickness tolerance of less than 2 mm, preferably less than 1 mm, more preferably less than 0.5 mm.
75. The modular foot prosthesis system according to any one of the claims 61 to 74, wherein the heel blade or at least its spring section has a top surface and a bottom surface with a surface parallelism when free from load of less than 3 mm over 100 mm, preferably less than 2 mm over 100 mm, more preferably less than 1 mm over 100 mm.
76. The modular foot prosthesis system according to any one of the claims 61 to 75, wherein the spring section of the heel blade has a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the heel blade measured in the widthwise direction, wherein the cumulative width profile of the heel blade varies in the lengthwise direction.
77. The modular foot prosthesis system according to claim 76, wherein the cumulative width profile of the heel blade comprises a variation of at least 5% from a maximum cumulative width of the heel blade.
78. The modular foot prosthesis system according to claim 76 or 77, wherein the cumulative width profile of the heel blade comprises one or more than one blade waist defined by a local minimum of the cumulative width profile of the heel blade.
79. The modular foot prosthesis system according to claim 78, wherein at least one of the one or more than one blade waist is at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile of the heel blade.
80. The modular foot prosthesis system according to claim 78 or 79, wherein at least one of the one or more than one the blade waist is arranged at a position in the lengthwise direction of the heel blade in the range of 20 to 80% of the total length of the heel blade.81 . The modular foot prosthesis system according to any one of the claims 61 to 80, comprising a plurality of heel blades, each coupled or couplable to at least one of a plurality of toe components comprised by the foot prosthesis system.
82. The modular foot prosthesis system according to any one of the claims 61 to 81 , further comprising:- a heel component forming a posterior aspect of the foot prosthesis and comprising a support surface coupled or couplable to the rear section of the heel blade.
83. The modular foot prosthesis system according to claim 82, wherein the support surface of the heel component extends in a plane.
84. The modular foot prosthesis system according to claim 82 or 83, wherein the heel component further comprises a curved surface arranged adjacent and anterior to the support surface of the heel component to support a part of the spring section adjacent to the rear section of the heel blade when flexed, wherein the curved surface of the heel component preferably has a radius of curvature which decreases in a direction away from the support surface of the heel component.
85. The modular foot prosthesis system according to any one of the claims 82 to 84, wherein the support surface of the heel component and the third support surface of the toe component extend in parallel planes, when the heel blade is coupled thereto and free from load, to support the heel blade relative to a planar external subsurface under an angle in the sagittal plane of less than 20°, preferably less than 10°, more preferably less than 3° or even parallel to said subsurface.
86. The modular foot prosthesis system according to any one of the claims 82 to 85, wherein the heel component further comprises a bottom face for supporting the user towards an external subsurface.
87. The modular foot prosthesis system according to any one of the claims 82 to 86, wherein the bottom face comprises a recess with a slotted rim for coupling replacement sole elements into the heel component.
88. The modular foot prosthesis system according to any one of the claims 82 to 87, wherein the heel component comprises a sidewall extending transversely relative to the support surface of the heel component and configured to abut the rear end and / or at least one lateral edge of the heel blade.
89. The modular foot prosthesis system according to any one of the claims 82 to 88, wherein the heel component comprises a protruding rim which is configured to receive the rear end of the main blade when the main blade and the heel blade are flexed towards each other.
90. The modular foot prosthesis system according to any one of the claims 82 to 89, wherein the heel component is only connected to the toe component via the heel blade.91 . The modular foot prosthesis system according to any one of the claims 82 to 90, comprising a plurality of heel components each coupled or couplable to at least one of a plurality of heel blades comprised by the foot prosthesis system.
92. The modular foot prosthesis system according to any one of the previous claims, further comprising the connection component coupled or couplable to the rear section of the main blade.
93. The modular foot prosthesis system according to claim 92, wherein the connection component is only connected to the toe component via the main blade.
94. The modular foot prosthesis system according to claim 92 or 93, wherein the connection component comprises a joint, such as a prosthetic ankle joint.
95. The modular foot prosthesis system according to any one of the previous claims, further comprising:- an auxiliary blade extending in a lengthwise direction between a front end and a rear end of the auxiliary blade, wherein the auxiliary blade comprises, consecutively from the front end to the rear end:- a front section coupled or couplable to the connection component;- optionally, a spring section for providing spring action; and- a rear section for coupling to an auxiliary connection component proximal to the user.
96. The modular foot prosthesis system according to claim 95, wherein the auxiliary blade is formed of a resilient material and / or a flat plate.
97. The modular foot prosthesis system according to claim 95 or 96, wherein the auxiliary blade or at least its spring section, when free from load, is planar.
98. The modular foot prosthesis system according to any one of the claims 95 to 97, wherein the auxiliary blade, in particular the spring section of the auxiliary blade, comprises a cumulative width profile defined as a cumulative width of resilient material present between opposite lateral outermost edges of the auxiliary blade measured in the widthwise direction comprising a variation of at least 5% from a maximum cumulative width of the auxiliary blade and / or one or more than one blade waist which is at most 95%, preferably at most 90%, of a maximum cumulative width of the cumulative width profile of the auxiliary blade.
99. The modular foot prosthesis system according to any one of the claims 95 to 98, wherein the main blade and the auxiliary blade are coupled or couplable to the connection component under an angle measured in the sagittal plane and when free from load that is at least 10°, preferably in the range of 10 to 170°, more preferably in the range of 10 to 80°.
100. The modular foot prosthesis system according to any one of the claims 95 to 99, further comprising the auxiliary connector component coupled or couplable to the rear section of the auxiliary blade.101 . The modular foot prosthesis system according to claim 100, wherein the auxiliary connection component comprises a joint, such as a prosthetic ankle joint or a prosthetic knee joint.
102. The modular foot prosthesis system according to any one of the previous claims, further comprising at least one of:- a first releasable coupling arranged to releasably couple the front section of the main blade to the first support surface of the toe component;- a second releasable coupling arranged to releasably couple the front section of the main blade to the second support surface of the toe component;- a third releasable coupling arranged to releasably couple the front section of the heel blade to the third support surface of the toe component;- a fourth releasable coupling arranged to releasably couple the rear section of the heel blade to the support surface of the heel component; and- a fifth releasable coupling arranged to releasably couple the rear section of the main blade to the connection component.
103. The modular foot prosthesis system according to claim 102, wherein at least one of the first to fifth releasable couplings comprises a clamp, a slot and pin connection, a biased locking lip connection or a bolt connection.
104. The modular foot prosthesis system according to any one of the previous claims, wherein a first hole is arranged in the front section of the main blade and a second hole is correspondingly arranged in the first support surface of the toe component to releasably couple the main blade to the toe component with a first pin or bolt arranged through the first and second holes.
105. The modular foot prosthesis system according to any one of the previous claims, wherein a third hole is arranged in the front section of the heel blade and fourth hole is correspondingly arranged in the third support surface of the toe component to releasably couple the heel blade to the toe component with a second pin or bolt arranged through the third and fourth holes.
106. The modular foot prosthesis system according to any one of the previous claims, wherein a fifth hole is arranged in the rear section of the main blade for aligning with a sixth hole correspondingly arranged in the connection component to releasably couple the main blade to the connection component with a third pin or bolt arranged through the fifth and sixth holes.
107. The modular foot prosthesis system according to any one of the previous claims, wherein the resilient material of the main blade and / or the heel blade and / or the auxiliary blade is formed of or comprises a laminate.
108. The modular foot prosthesis system according to claim 107, wherein the laminate comprises one or more than one composite layer.
109. The modular foot prosthesis system according to claim 108, wherein composite layer comprises a fibre-reinforced resin, preferably comprising glass fibres and / or carbon fibres.
110. The modular foot prosthesis system according to any one of the previous claims, wherein the toe component is formed of a composite material in which one or more than one insert is arranged, wherein the insert comprises an internal thread for engaging an external thread of a coupling device, such as a bolt, to fix at least one of the main blade, the heel blade, the toe cap and the sole cap to the toe component.
111. The modular foot prosthesis system according to any one of the previous claims, wherein the heel component is formed of a composite material in which one or more than one insert is arranged, wherein the insert comprises an internal thread for engaging an external thread of a coupling device, such as a bolt, to fix the heel blade to the toe component.
112. The modular foot prosthesis system according to claim 110 or 111 , wherein:- the insert is formed of a metal, preferably titanium; and- the composite material is formed of fibre-reinforced resin moulded around the metal inserts, preferably wherein the fibre-reinforced resin has fibres in a random orientation, the fibres more preferably being carbon fibres.
113. The modular foot prosthesis system according to any one of the previous claims, further comprising a bottom support blade which is arranged between the first support surface of the toe component and the main blade and which extends from the front section of the main blade along a part of the spring section of the main blade clearing the rear section of the main blade.
114. The modular foot prosthesis system according to claim 113, further comprising a bottom slide layer interposed between the bottom support blade and the main blade.
115. The modular foot prosthesis system according to any one of the previous claims, further comprising a top support blade which is arranged over the top surface of the main blade, preferably between the main blade and the connection component when present, and which extends from the rear section of the main blade along a part of the spring section of the main blade clearing the front section of the main blade.
116. The modular foot prosthesis system according to claim 115, further comprising a top slide layer interposed between the bottom support blade and the main blade.
117. A main blade of or for a modular foot prosthesis system according to any of the claims 1 to 116.
118. A method of manufacturing a main blade according to claim 117, the method comprising cutting a plate of resilient material into the shape of the main blade.
119. A toe component of or for a modular foot prosthesis system according to any of the claims 1 to 116.
120. A method of manufacturing a toe component according to claim 119, the method comprising:- positioning inserts into a mould shaped to form the toe component;- filling the mould with fibre-reinforced resin, in particular using randomly oriented fibres of carbon and / or glass;- allowing the resin to cure, preferably under the application of pressure and / or temperature control, more preferably to obtain a forged composite; and- opening the mould to obtain the toe component having the inserts embedded in the cured resin.121 . A heel blade of or for a modular foot prosthesis system according to any of the claims 61 to 116.
122. A method of manufacturing a heel blade according to claim 121 , the method comprising cutting a plate of resilient material into the shape of the heel blade.
123. A heel component of or for a modular foot prosthesis system according to any of the claims 82 to 116.
124. A method of manufacturing a heel component according to claim 123, the method comprising:- positioning inserts into a mould shaped to form the heel component;- filling the mould with fibre-reinforced resin, in particular using randomly oriented fibres of carbon and / or glass;- allowing the resin to cure, preferably under the application of pressure and / or temperature control, more preferably to obtain a forged composite; and- opening the mould to obtain the heel component having the inserts embedded in the cured resin.
125. A lower-extremity prosthesis comprising at least one of:- a modular prosthesis system according to any one of the claims 1 to 116;- a main blade according to claim 117 or obtainable according to the method of claim 118;- a toe component according to claim 119 or obtainable according to the method of claim 120; - a heel blade according to claim 121 or obtainable according to the method of claim 122; and- a heel component according to claim 123 or obtainable according to the method of claim 124.
126. A method of adapting a lower-extremity prosthesis according to claim 125 comprising at least one of the main blade and the heel blade, the method comprising at least one of: - adapting the width profile of the spring section of the main blade; and- adapting the width profile of the spring section of the heel blade.
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