Prosthesis or orthosis with variable hinge stiffness

Abstract

A prosthesis or orthosis comprising a hinge joint system for functionally assisting, augmenting and / or replacing a human or animal subject, the hinge joint system comprising: a first member (10); a second member (20) pivotally attached to the first member; a link element or actuator (30) connected to the first member; a flexible member (40) connecting the second member and the link element or actuator; at least one contact reinforcing element (50) configured to be in contact with or into contact with the flexible member and configured to provide a leverage along the length of the flexible member.

Description

Technical Field

[0001] The field of the invention relates to prostheses or orthoses with variable hinge stiffness.Detailed Description The invention relates to matters relating to prostheses or orthoses for functional assistance, augmentation and / or replacement of a limb of a human or animal subject, or for augmenting the body or a part of the body of a human or animal subject. Background Art

[0002] Reproducing the joint motion that occurs naturally in humans and animals in existing prostheses or orthoses remains a complex technical challenge. In fact, the human body uses a periodic sequence of limb movements to move the body forward and maintain postural stability, for example when walking. This is achieved through a process known as the double pendulum. Although walking is by far the most basic and common thing in life, it involves very complex mechanisms, including energy storage, transfer and return, which rely on highly complex anatomical bone, muscle and tendon structures. The main mechanical challenge lies in accurately converting between the different phases of the periodic sequence caused by limb movement so that the user of the prosthesis or orthosis has a more comfortable experience during use. However, each person has a periodic sequence with different conversion times, which affect the force applied during joint movement. For the same person, different responses to the force are required during different phases of the periodic sequence caused by limb movement to be closer to natural movement.

[0003] In the prior art solutions, in order to solve the above problems, the periodic sequence conversion is accomplished by complex mechanical features in the hinge joint system, thereby significantly increasing the production cost of the prosthesis or orthosis and making the applicability to individual users more complicated. Therefore, there is a need for a prosthesis or orthosis including a hinge joint system that allows easier mechanical adaptation to individual users and enables the response to be varied during different phases of the periodic sequence caused by limb movement. Summary of the invention

[0004] It is an object of embodiments of the present invention to provide a prosthesis or orthosis comprising a hinge joint system that allows for easy user customizability while having a reliable mechanical structure and allowing for variations in the mechanical response at different positions of the hinge joint.

[0005] According to one aspect of the present invention, a prosthesis or orthosis is provided, which includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal body. The hinge joint system includes: a first member; a second member pivotally attached to the first member; a link element or actuator connected to the first member; a flexible member, the flexible member is connected to the second member at a first end and to the link element or actuator at a second end; at least one contact reinforcement element, at least one contact reinforcement element is configured to contact or enter contact with the flexible member, and is configured to provide leverage along the length of the flexible member. At least one contact reinforcement element allows the hinge stiffness between the first member and the second member to vary.

[0006] Hinge stiffness refers to the resistance to a torque about a pivot axis between the first and second members that causes the first member to pivot relative to the second member.

[0007] Depending on the embodiment, the at least one contact reinforcing element may be a separate mechanical component attached to the structure of the prosthesis or orthosis, or may be integrated (ie made in one piece) as part of the structure of the prosthesis or orthosis.

[0008] By providing at least one contact reinforcing element, a lever action allows for an increase in hinge stiffness due to a forced inflection point created by the at least one contact reinforcing element contacting the flexible member, depending on the working direction of the flexible member. By adjusting the distance of the flexible member relative to the outer surface of the at least one contact reinforcing element, the time at which the lever action affects the hinge movement during the movement of the limb being replaced or assisted can be tuned. By adjusting the position of the at least one contact reinforcing element relative to the length of the flexible member, the increase in hinge stiffness can be tuned.

[0009] In a prosthesis or orthosis, the first member and the second member may correspond to the parts of the hinged limb, and the hinge joint system may correspond to the corresponding joint, such as the ankle joint. For example, in the case of a foot prosthesis or orthosis, the load will be transferred between the first member and the flexible member during dorsiflexion and plantar flexion. The transfer of load between the first member and the flexible member means that the force applied to the first member is directly converted into positive and negative loads acting on the flexible member and stored as energy, and conversely, the energy stored in the flexible member is directly applied to the first member as a load and converted into a force. Since the second member is fixed to the flexible member, the force applied to the second member may also end up with the load transfer between the first member and the flexible member.

[0010] Then, since the flexible member is mounted in the mechanical structure of the prosthesis or orthosis to act on the rotation about the first axis, and since the linkage element or actuator is mounted between the first member and the flexible member, a torque is generated between the first member and the second member. This torque may depend on, among other factors, the transmission variation of the linkage element or actuator, the external force applied to the first member, the external force applied to the second member, the mechanical characteristics of the flexible member and / or other forces applied to the flexible member by the linkage element or actuator.

[0011] Since the flexible member is fixed to the second member on the one hand and to the link element or the actuator on the other hand, and since the second member is pivotably connected to the first member, a torque is generated between the first member and the second member about the first axis, thereby achieving a rotation of the second member relative to the first member about the first axis.

[0012] When a force is applied to the second member, a rotation of the flexible member relative to the first member is achieved. The rotation may be caused by a restoring force of the flexible member, which then acts on a rotation of the second member relative to the first member about the first axis. In addition, due to the flexible member, the load applied by the subject wearing the prosthesis or orthosis can be stored and released, thereby improving the energy efficiency of the prosthesis or orthosis.

[0013] The linkage element may have a fixed length. The actuator may include additional active or passive elements to provide energy for the movement of the first member relative to the second member. Examples of active elements include linear or rotary motorized actuators. Examples of passive elements include elastic elements that store energy generated by the applied load.

[0014] According to an embodiment, at least one contact strengthening element may be provided on one side of the flexion and / or extension of the flexible member. In addition, more than one contact strengthening element may be provided to the same side at different positions along the length of the flexible member and at the same or different distances relative to the flexible member.

[0015] It should be noted that the contact between the contact strengthening element and the flexible component may be a contact point, a contact line or a contact surface.

[0016] Preferably, at least one of the at least one contact strengthening element is configured to come into contact with the flexible member during flexion or extension of the first member relative to the second member.

[0017] Flexion and extension are movements that occur in the sagittal plane and involve forward and backward movement of the body or limb. In the limbs, flexion decreases the angle between the bones (bending the joint), while extension increases the angle and straightens the joint.

[0018] By acting on motion occurring in the sagittal plane, the most important motion of the limb is addressed using at least one contact reinforcing element. Those skilled in the art will appreciate that the same principles can be applied to torsional motion of the limb.

[0019] According to a preferred embodiment, at least one of the at least one contact strengthening element comprises a core made of a first material and a cladding surrounding the core made of a second material, wherein the second material has a greater elasticity than the first material.

[0020] In this way, due to the higher elasticity of the second material, the change in hinge stiffness caused by the contact strengthening element of at least one contact strengthening element coming into contact with the flexible member is smoothed. In an embodiment, the core may be made of metal, preferably steel, and the cladding may be made of silicone or rubber.

[0021] Preferably, the core has a cylindrical shape to provide a contact line across the width of the flexible member.The cladding may be designed to have a desired profile to further tune the rate of change of hinge stiffness as the flexible member and one of the at least one contact strengthening elements move further into contact with each other.

[0022] In other embodiments, the core may have an oval, triangular, or rectangular profile.

[0023] Those skilled in the art will appreciate that the cladding may include a third material having a different elasticity than the first and second materials to further tune the rate of change of the hinge stiffness during contact.

[0024] According to an exemplary embodiment, at least one of the at least one contact strengthening element is coupled to the second component. Additionally or alternatively, at least one of the at least one contact strengthening element is coupled to the first component.

[0025] In this manner, contact between one of the at least one contact reinforcing elements and the flexible member may be achieved in a dynamic or static manner. Since the flexible member is connected to the second member, contact is achieved in a static manner when one of the at least one contact reinforcing elements is coupled to the second member, thereby providing a more accurate prediction of changes in hinge stiffness. Since the flexible member is connected to a link element or actuator that is pivotally connected to the first member, contact is achieved in a dynamic manner when one of the at least one contact reinforcing elements is coupled to the first member, thereby further improving the potential tunability of nonlinear changes in hinge stiffness during movement of the prosthesis or orthosis.

[0026] According to an exemplary embodiment, the flexible member comprises a leaf spring.At least one of the at least one contact strengthening element is configured to provide a lever axis extending across a width of the flexible member.

[0027] With a lever axis extending over the width of the flexible member, the lever action exerted by the contact reinforcing element will be applied uniformly in the direction opposite to the working direction. Furthermore, a twisting of the flexible member can also be prevented. Depending on the embodiment, the leaf spring can be straight or curved. Furthermore, at the level of the connection between the flexible member and the connecting rod element or the actuator, a ball joint can also be used in addition to the leaf spring.

[0028] According to a preferred embodiment, at least one of the at least one contact reinforcing element is mounted in a detachable manner.

[0029] In this way, it is easy to replace the at least one contact strengthening element in the at least one contact strengthening element. In addition, different contact strengthening elements can be used according to the user to further adapt the effect of the flexible member to the user.

[0030] According to an exemplary embodiment, at least one of the at least one contact enhancing element is movable to a plurality of contact positions to provide a corresponding plurality of lever actions along the length of the flexible member.

[0031] In this way, the use of the prosthesis or orthosis can be more easily adapted to different types of activities and / or ground qualities during use. Indeed, in the example of a foot prosthesis or orthosis, the response of the prosthesis or orthosis to the forces applied to the flexible member will be different depending on whether the ground is inclined upwards or downwards, depending on whether the user is sitting, walking or running, and depending on whether the ground is a forest floor or a concrete floor. By means of movable contact reinforcing elements, the leverage applied due to the contact between the contact reinforcing elements can be further tuned to better adapt to a variety of environmental and activity-related conditions. In other words, the torque characteristics can be changed by changing the contact position.

[0032] In one embodiment, the contact enhancing element includes a rotatable cam having an elongated profile, and depending on the angular positioning of the cam, the leverage provided by the contact enhancing element can be made harder or less stiff by moving the contact point between the rotatable cam and the flexible member closer to or farther away from a midpoint along the length of the flexible member.

[0033] In another embodiment, the contact enhancing element comprises a sliding pin extending perpendicularly relative to the length of the flexible member. The sliding pin is configured to slide along the length of the flexible member toward or away from a midpoint, thereby moving a contact point between the sliding pin and the flexible member.

[0034] According to a typical embodiment, the at least one movable contact strengthening element is configured to be moved from a first contact position of the plurality of contact positions to a second contact position of the plurality of contact positions by a motorized positioning actuator.

[0035] By this method, the movable contact reinforcing element can be moved more conveniently. Preferably, when the flexible element is not in contact with the movable contact reinforcing element, the movable contact reinforcing element moves from the first contact position to the second contact position to avoid excessive burden on the motorized positioning actuator.

[0036] According to a preferred embodiment, the flexible member comprises a front portion, a middle portion and a rear portion. The average cross-section per unit length of the middle portion comprises less material than the average cross-section per unit length of the front portion or the rear portion.

[0037] The average cross-section of the middle portion may include less material due to initial shaping of the flexible member, due to removal of material from its sides by machining, and / or due to removal of material by perforating the middle portion of the flexible member.

[0038] Preferably, the front portion has a first width, the middle portion has a second width, and the rear portion has a third width, respectively, when viewed in a transverse direction perpendicular to the length direction of the flexible member. The second width is less than the first width and / or the third width. In another embodiment, the front portion has a first thickness, the middle portion has a second thickness, and the rear portion has a third thickness. The second thickness is less than the first thickness and / or the second thickness.

[0039] Alternatively, the average cross-section per unit length of the middle portion includes more material than the average cross-section per unit length of the front position or the rear portion. The average cross-section of the middle portion may include more material due to the initial shaping of the flexible member and / or due to added material fixed to the middle portion of the flexible member.

[0040] In this way, a load applied to the front portion or the rear portion will trigger deformation of the flexible member along its length. The front portion and the rear portion can be used as fixing points for connecting devices (such as brackets, clamps, bolts and / or chemical adhesives). In other words, the middle portion is the portion of the flexible member that is not fixedly constrained and can move and deform freely.

[0041] The overall flexibility characteristics of the flexible member can be tuned by tuning the geometry of the middle portion. In one embodiment, the width of the flexible member can be constant over the length of the middle portion, and the flexible member can be adjusted from user to user by increasing or decreasing the width of the middle portion. In another embodiment, the width of the flexible member can follow a parabolic profile, with the largest at the rear and front portions. Additionally or alternatively, the thickness of the middle portion can also be adjusted from user to user in the same manner relative to the width of the middle portion.

[0042] According to an exemplary embodiment, the front portion and the rear portion of the flexible member are each provided with at least one hole, the at least one hole being configured to cooperate with the coupling device.

[0043] In this way, the number of components included in the flexible member can be reduced, thereby reducing the overall cost of the flexible member and providing better mechanical reliability. The coupling means may comprise a bolt cooperating with at least one hole, preferably a plurality of holes at each of the front and rear parts.

[0044] According to a preferred embodiment, the flexible member is made in one piece.

[0045] In this way, the mechanical reliability of the flexible member is improved and the manufacture of the flexible member is simplified. For example, the manufacture of the flexible member may include cutting the desired material into the shape of the flexible member. The flexible member may be made of metal (e.g., steel or aluminum) or a composite material (e.g., carbon or fiberglass). The flexible member may be manufactured by cutting (e.g., water jet cutting), grinding and / or molding.

[0046] According to an exemplary embodiment, the flexible member has a constant thickness when viewed along the length of the flexible member. Constant thickness means that a thickness variation of plus or minus 20% along the length of the flexible member is acceptable.

[0047] Furthermore, a fiber layer may be added to the thickness of the flexible member at the front portion and / or the rear portion of the flexible member.

[0048] In this way, the overall design of the flexible member is simplified so that the flexible member can be more easily adjusted according to the user. Manufacturing is also simplified. In addition, the mechanical reliability of the flexible member remains unchanged in the working direction of the flexible member (i.e., in the direction perpendicular to the length of the flexible member).

[0049] According to a preferred embodiment, the flexible member is flat.

[0050] Flat refers to the overall shape of the flexible member, wherein when the flexible member is installed in a prosthesis or orthosis, the flexible member remains straight in a resting position of the prosthesis or orthosis.

[0051] In this way, the manufacture of the flexible component is simplified.

[0052] In another embodiment, the flexible member is curved or even wavy, thereby providing a modified mechanical response of the flexible member depending on the working direction.

[0053] According to an exemplary embodiment, the flexible member comprises or consists of a plate-like element.

[0054] The plate-like element refers to the manufacture of the main component constituting the flexible member. This main component originates from a sheet of material and is not substantially modified by additional manufacturing steps. This main component may be provided with coupling means to realize the flexible member.

[0055] In this manner, manufacturing may include cutting the desired shape of the flexible member directly into the selected material.

[0056] According to a preferred embodiment, the flexible member is configured to provide a hinge stiffness between the first member and the second member in the range of -40 Nm / degree to 40 Nm / degree.

[0057] In this way, the flexible member, when installed in a prosthesis or orthosis, is adapted to the forces normally applied by a user of the prosthesis or orthosis.

[0058] According to an exemplary embodiment, the flexible member includes a cushioning member, such as a cushioning layer, configured to contact at least one contact strengthening element.

[0059] The buffer member may include an elastic material (e.g., silicone, rubber) that can soften the steepness of the change in hinge stiffness when the flexible member contacts at least one contact reinforcing element. Those skilled in the art will appreciate that different shapes and / or material combinations may be used to implement the buffer member, depending on the desired change curve for the change in hinge stiffness. The buffer member may be a homogeneous layer, or may have an adjusted shape and / or density distribution. Optionally, the buffer member may be made by 3D printing.

[0060] According to a preferred embodiment, at least one contact reinforcing element is integrated as part of the first component or the second component.

[0061] Integration means that the at least one contact reinforcement element is integrally formed, for example by casting, as part of another component, the other component comprising the first component or the second component. By integrating the at least one contact reinforcement element, mechanical fatigue on the at least one contact reinforcement element can be reduced. At the same time, the contact reinforcement element can play another role as a reinforcement structure part of the first component or the second component.

[0062] According to an exemplary embodiment, the second member is made of a rigid material. For example, the second member can be made of a metal (eg, aluminum, titanium) or a composite material (eg, carbon).

[0063] In this way, modeling of the forces acting on the different elements of the prosthesis or orthosis and directly related to the flexible member is more easily performed. Thus, the flexible member can be tuned more accurately with respect to a selected user.

[0064] "Flexible" means that when the flexible component is installed in the prosthesis or orthosis, it will show visible deformation when the user uses the prosthesis or orthosis normally. In contrast, the second component made of a rigid material will not show any visible deformation when the user uses the prosthesis or orthosis normally after being installed in the prosthesis or orthosis.

[0065] According to a preferred embodiment, the second member is defined by a bottom panel and / or a top panel, and two side wings. The bottom panel and / or the top panel are interconnected with the two side wings. The flexible member is connected to the bottom panel or the top panel. The side wings extend on both sides of the flexible member. The first member is preferably pivotally connected to the two side wings.

[0066] In this way, a relatively light second member is obtained while defining the second member as a structurally rigid element.In addition, one or more openings may be provided for each wing in order to further reduce the weight of the second member.

[0067] For example, in the case of a foot prosthesis or orthosis, the wings are preferably triangular shaped to approximate the shape of the foot.

[0068] Those skilled in the art will appreciate that the features and advantages of the above-described aspects relating to prosthetic and orthotic embodiments apply mutatis mutandis to the following aspects relating to prosthetic and orthotic embodiments.

[0069] According to a second aspect of the present invention, there is provided a prosthesis or orthosis comprising a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal subject. The hinge joint system comprises: a first member; a second member pivotally attached to the first member; a link element or actuator connected to the first member; and a flexible member connected to the second member at a first end and to the link element or actuator at a second end.

[0070] The flexible member is capable of acting on a torque about a first axis, and thereby acting on a rotation, by being connected at a first end to a second member connection and at a second end to a linkage element or an actuator connection. The flexible member is configured to store energy when a load is applied thereto. Depending on the working direction of the flexible member (the direction in which the load is applied) and the type of flexible member, the load applied to the flexible member may be the result of applied torsion, elongation, tension and / or compression.

[0071] Since control of rotation about the first axis in the hinge joint system relies primarily on a single mechanical piece of the flexible member, user customizability may be advantageously implemented by simply tuning the characteristics of that mechanical element.

[0072] According to a third aspect of the present invention, a prosthesis or orthosis is provided, which includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal body. The hinge joint system includes: a first member; a second member pivotably attached to the first member; a link element or an actuator connected to the first member; a flexible member connected to the second member at a first end and to the link element or the actuator at a second end; at least one contact reinforcing element configured to enter into contact with the flexible member during use of the prosthesis or orthosis, and configured to provide leverage along the length of the flexible member. At least one contact reinforcing element allows the hinge stiffness between the first member and the second member to change when entering contact. At least one contact reinforcing element and the flexible member are not bound. In other words, the flexible member and the at least one contact reinforcing element are physically different and are not linked by additional mechanical components.

[0073] Considering a complete movement cycle of the hinge joint system that the prosthesis or orthosis functionally assists, enhances and / or replaces, at least one contact reinforcing element is configured to come into contact with the flexible member during at least a portion of the movement cycle. During this portion of the movement cycle, when the flexible member is in contact with the at least one contact reinforcing element, the hinge stiffness of the flexible member changes compared to the rest of the movement cycle due to the additional leverage provided by the contact between the at least one contact reinforcing element and the flexible member.

[0074] In some embodiments, when the prosthesis or orthosis is in a resting state, at least one contact strengthening element can be in contact with the flexible member. The contact can be broken during a first portion of the motion cycle, and during a second portion of the motion cycle, at least one contact strengthening element and the flexible member can be brought into contact again.

[0075] Those skilled in the art will appreciate that the features and advantages of the above-described aspects relating to prosthetic and orthotic embodiments apply mutatis mutandis to the following aspects relating to method embodiments.

[0076] According to a fourth aspect of the present invention, there is provided a method of adapting a prosthesis or an orthosis to a user. The method of adapting a prosthesis or an orthosis to a user comprises:

[0077] - Obtain the user's total weight and / or height;

[0078] - providing a user with a prosthesis or orthosis comprising a hinge joint system for functionally assisting, augmenting and / or replacing a hinge joint system of a human or animal body, the hinge joint system comprising a first member, a second member pivotably attached to the first member, and a linkage element or actuator connected to the first member;

[0079] - Based on the acquired total body weight and / or body height, installing the flexible member in the prosthesis or orthosis by connecting the flexible member at a first end of the flexible member to a second member and at a second end of the flexible member to a linkage element or an actuator.

[0080] Those skilled in the art will appreciate that the embodiments of the prosthesis or orthosis provided to implement the above method may be similar to the embodiments of the prosthesis or orthosis described above.

[0081] In this way, by installing only one adaptable component of the prosthesis or orthosis, namely the flexible member, a substantial customization of the mechanical response from the prosthesis or orthosis can be achieved in a simpler and faster manner.

[0082] According to an exemplary embodiment, the method further comprises, before installing the flexible member, tuning the flexible member based on the acquired total weight and / or height.

[0083] According to yet another embodiment, the tuning includes removing an amount of material from and / or adding an amount of material to the middle portion of the flexible member based on the acquired total weight and / or height.

[0084] According to an exemplary embodiment, the method further comprises installing at least one contact reinforcement element in the prosthesis or orthosis based on the acquired total weight and / or height, wherein the at least one contact reinforcement element is configured to contact or enter into contact with the flexible member and to provide leverage along the length of the flexible member.

[0085] In this way, the mechanical response from the prosthesis or orthosis can be further customized, thereby making the user more comfortable by providing a more natural behavior of the prosthesis or orthosis.

[0086] According to another embodiment, the installation of at least one contact reinforcement element includes at least one of the following: adjusting the shape of at least one contact reinforcement element, adjusting the constituent material of at least one contact reinforcement element, adjusting the lateral positioning of at least one contact reinforcement element, adjusting the number of at least one contact reinforcement element, and adjusting the relative distance between at least one contact reinforcement element and the flexible component in the rest position.

[0087] Optionally, the method further comprises providing a cushioning member for the flexible member, the cushioning member being configured to contact the at least one contact strengthening element. Optionally, the cushioning member may be designed or selected based on the acquired total weight and / or height. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] These and other aspects of the invention will now be described in more detail with reference to the accompanying drawings, which show currently preferred embodiments. In the drawings, like numerals represent like features.

[0089] Figure 1 shows a cut-away side view of an exemplary embodiment of a prosthesis or orthosis;

[0090] Figure 2 depicts a top view of an exemplary embodiment of a flexible member;

[0091] FIG. 3A to FIG. 3C schematically illustrates a side view of another exemplary embodiment of a prosthesis or orthosis;

[0092] FIG. 4A to FIG. 4C schematically illustrates a side view of yet another exemplary embodiment of a prosthesis or orthosis;

[0093] FIG. 5A to FIG. 5B depicts simple schematic diagrams of exemplary embodiments of a foot prosthesis or orthosis and a knee prosthesis or orthosis, respectively;

[0094] Figure 6 Shows Figure 1 A perspective view of a second member of a prosthetic or orthotic embodiment of the invention;

[0095] Figure 7 shows a top view of another exemplary embodiment of a flexible member according to the present invention;

[0096] Figure 8 depicts a side view of yet another exemplary embodiment of a flexible member according to the present invention;

[0097] FIG. 9A to FIG. 9B A top perspective view of another exemplary embodiment of a flexible member and yet another exemplary embodiment of a prosthesis or orthosis according to the present invention are shown, respectively;

[0098] FIG. 10A to FIG. 10B Two different side views of an exemplary embodiment of a foot prosthesis or orthosis with a movable contact reinforcement element are schematically shown. DETAILED DESCRIPTION

[0099] Figure 1 A cutaway side view of an exemplary embodiment of a prosthesis or orthosis according to the present invention is shown. The prosthesis or orthosis includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal subject. The hinge joint system includes: a first member 10; a second member 20 pivotally attached to the first member 10; a link element or actuator 30 connected to the first member 10; a flexible member 40 connected to the second member 20 at a first end 40a and connected to the link element or actuator 30 at a second end 40c.

[0100] For the sake of simplicity, an embodiment of a foot prosthesis with an ankle joint system for a human subject will be described in detail below. However, those skilled in the art will appreciate that the features disclosed below can be freely adapted to, for example, an animal subject or other limbs.

[0101] The first member 10 may be configured to be attached to a limb of a user, such as the tibia for a transtibial foot prosthesis. The first member 10 is pivotally coupled to the second member 20 about an axis A1. Figure 1 In the embodiment, the linkage element or actuator 30 is pivotally coupled to the flexible member 40 about a second second axis A2". The second second axis A2" is substantially parallel to the first axis A1. The linkage element or actuator 30 is also pivotally coupled to the first member 10 about a first second axis A2', which is also substantially parallel to the first axis A1.

[0102] In short, when a force is applied to the first member 100, the force is converted into a load (positive load or negative load), acts on the flexible member 40 and is stored as energy. Conversely, the energy stored in the flexible member 40 is directly applied to the first member 10 as a load and converted into a force. Figure 1 Given the form factor of the flexible member 40 and the attachment to the second member 20, energy storage will manifest itself as deformation of the flexible member 40 along its length.

[0103] exist Figure 1 In an embodiment, the connecting rod element 30 has a fixed length. In another embodiment, the connecting rod element 30 can be replaced by an actuator. The actuator may include additional active or passive elements to provide energy for the movement of the first member relative to the second member. Examples of active elements include linear or rotary motorized actuators. Examples of passive elements include elastic elements that store energy generated by the application of a load. The actuator may also include a torque control mechanism as described in patent application NL2030109.

[0104] The second member 20 may be composed of a bottom and / or top panel, Figure 1 The bottom panel 21 and two side wings 22 are preferably made of a rigid material, such as metal or a composite material (such as carbon). Figure 1 In the embodiment of the present invention, the bottom panel 21 and the two side wings 22 are connected to each other. Figure 1 The second member 20 shown includes a sole member 23, preferably made of a composite material (e.g., carbon) or aluminum. The sole member 23 may be configured to be covered with a rubber layer (not shown) or an integral foot cover (not shown) configured to contact the ground during the gait cycle. The flexible member 40 is fixed to the second member 20 and is preferably made of a composite material (e.g., carbon) or aluminum. Figure 1In the embodiment of the present invention, the flexible member 40 is fixed to the bottom panel 21. The fixing of the flexible member 40 can be completed by the bracket 24a and the connecting device 25 (such as a bolt). The front part 40a of the flexible member 40 is fixed between the bracket 24a and the top surface of the bottom panel 21. More specifically, in Figure 1 In the embodiment of the present invention, the bolt heads are concealed using a compartment defined by a recess in the bottom surface of the bottom panel 21 and the sole element 23. Alternatively or additionally, the coupling means may include brackets, clamps, bolts, brackets and / or chemical adhesives.

[0105] The side wings 22 may extend substantially perpendicularly relative to the bottom panel 21 on both sides of the flexible member 40. The first member 10 is pivotally connected to the two side wings 22 about the first axis A1. Figure 1 In the embodiment of the present invention, the side wings 22 are generally triangular in shape to approximate the shape of a foot, and each side wing is provided with an opening 26. Figure 6 .

[0106] The flexible member 40 includes a front portion 40a, a middle portion 40b, and a rear portion 40c. Figure 2 The embodiment of the flexible member 40 is better described. The rear portion 40c serves as a fixed point for the linkage element 30 or the actuator about the second second axis A2". Similar to the front portion 40a, Figure 1 In the embodiment of the present invention, the bracket 24c pivotally connected to the linkage member 30 is used in conjunction with a coupling device (such as a bolt) to fix the rear portion 40c. Figure 1 As shown, the thickness of the flexible member 40 is constant along its length.

[0107] The prosthesis or orthosis may also include at least one contact strengthening element 50 configured to contact or enter into contact with the flexible member 40 (at Figure 1 A single contact strengthening element 50 is configured to enter into contact) and provide a leverage along the length of the flexible member 40 to change the hinge stiffness between the first member 10 and the second member 20. Preferably, at least one of the at least one contact strengthening element 50 is configured to enter into contact during flexion or extension of the first member 10 relative to the second member 20 (in Figure 1 In the embodiment, during the flexion of the first member 10 relative to the second member 20, the flexible member 40 comes into contact with the flexible member 40.

[0108] According to an embodiment, at least one contact strengthening element 50 may be provided on the side of the flexion and / or extension of the flexible member 40. In addition, more than one contact strengthening element 50 may be provided to the same side at different positions along the length of the flexible member 40 and at the same or different distances relative to the flexible member 40. The contact between the contact strengthening element of the at least one contact strengthening element 50 and the flexible member 40 may be a contact point, a contact line, or a contact surface. Additional embodiments of the at least one contact strengthening element 50 for a prosthesis or orthosis may refer to FIG. 3A to FIG. 3C and FIG. 4A to FIG. 4C .

[0109] exist Figure 1 In an embodiment, the contact reinforcement element 50 includes a core 51 made of a first material and a cladding 52 surrounding the core 51 made of a second material. The second material has greater elasticity than the first material. For example, the core 51 can be made of metal and the cladding 52 can be made of silicone or rubber. The core 51 is cylindrical so that a contact line across the width of the flexible member 40 can be provided. The cladding 52 has a curved profile so that as the flexion of the first member 10 relative to the second member increases, the contact surface with the flexible member 40 is increased. In other embodiments, the core can be spherical, or can be an elliptical, triangular or rectangular profile. In addition, those skilled in the art will understand that the cladding may include a third material having an elasticity different from the first material and the second material to further adjust the rate of change of the hinge stiffness during contact.

[0110] In addition, Figure 1 In an embodiment, the contact reinforcing element 50 is coupled to the second member 20 in front of the first axis A1. The contact reinforcing element 50 can be detachably coupled to the second member 20. In the neutral (or resting) position of the prosthesis or orthosis, the contact reinforcing element 50 is located at a distance from the surface of the flexible member 40. The contact reinforcing element 50 is disposed facing the rear half of the flexible member 40. In another embodiment, at least one of the at least one contact reinforcing element is coupled to the first member 10.

[0111] like Figure 1 As shown, during the flexion of the first member 10 relative to the second member 20, the flexible member 40 will come into contact with the contact reinforcement element 50. When entering into contact, the lever arm generated by the flexible member 40 decreases in length due to the forced inflection point achieved by the contact reinforcement element 50, so the hinge stiffness around the first axis A1 will increase.

[0112] Those skilled in the art will appreciate that many schemes for variable hinge stiffness may be achieved by using one or more contact stiffening elements at different locations relative to the flexible member.

[0113] Figure 2 A top view of an exemplary embodiment of a flexible member according to the present invention is shown. The flexible member 40 includes a front portion 40a, a middle portion 40b, and a rear portion 40c. The front portion 40a has a first width w1, the middle portion 40b has a second width w2, and the rear portion 40c has a third width w3.

[0114] The average cross-section per unit length of the middle portion 40b includes less material than the average cross-section per unit length of the front portion 40a or the rear portion 40c. More specifically, Figure 2 In an embodiment, the second width w2 is smaller than the first width w1 and the third width w3. When viewed along the length direction of the flexible member 40, the flexible member 40 has a constant thickness. The second width w2 of the flexible member can be constant over the entire length of the middle portion 40b, and by increasing or decreasing the second width w2, the flexible member 40 can be adjusted according to different users. In addition, the flexible member 40 is flat and consists of a plate-like element. Preferably, the plate-like element forms a leaf spring.

[0115] In another embodiment, the flexible member can be curved. In yet another embodiment, the width of the flexible member can follow a parabolic profile, being largest at the rear and front portions. Additionally or alternatively, the thickness of the middle portion can also be adjusted to different users in the same manner as described for the width of the middle portion.

[0116] exist Figure 2 In the embodiment of the present invention, both the rear part 40c and the front part 40a can be provided with a plurality of holes 41a, 41c, two holes 41c in the rear part 40c and four holes 41a in the front part 40a, configured to cooperate with a coupling device (not shown), such as a corresponding plurality of bolts. The U-shaped opening 42c in the rear part 40c can allow the end of a connecting rod element or an actuator (not shown) to be arranged therein to improve compactness.

[0117] Figure 7 and Figure 8 A top view and a side view are respectively shown of other exemplary embodiments of the flexible member according to the present invention.

[0118] exist Figure 7 In the embodiment of the present invention, the flexible member 40' includes a front portion 40a', a middle portion 40b' and a rear portion 40c'. Figure 8 In the embodiment of the present invention, the flexible member 40" includes a front portion 40a", a middle portion 40b" and a rear portion 40c". Figures 7 and 8 In an embodiment, the average cross-section per unit length of the middle portion includes more material than the average cross-section per unit length of the front portion or the rear portion.

[0119] The flexible members 40', 40" have a constant thickness when viewed along the length direction of the flexible members 40', 40". The width of the flexible members 40', 40" may be constant over the entire length of the middle portion 40b', 40b", and by increasing or decreasing the width of the middle portion 40b', 40b", the flexible members 40', 40" may be adjusted to different users. In addition, the flexible members 40', 40" are flat and consist of a plate-like element. Preferably, the plate-like element forms a leaf spring.

[0120] exist Figure 7 In an embodiment, both the rear portion 40c' and the front portion 40a' may be provided with a plurality of holes 40a', 41c', two holes 41c' in the rear portion 40c' and four holes 41a' in the front portion 40a', configured to cooperate with a coupling device (not shown), for example, with a plurality of corresponding bolts. When viewed from the top, the rear portion 40c' may have a tapered profile. The front portion 40a' may have a constant width along its length. In an alternative embodiment, when viewed from the top, the front portion 40a' and the rear portion 40c' may both have a tapered profile, and two holes may be provided respectively. In yet another embodiment, when viewed from the top, the front portion 40a' may have a tapered profile, and the rear portion 40c' may have a constant width along its length.

[0121] exist Figure 8 In the embodiment, the front portion 40a" can be Figure 7 The rear portion 40c" is similar to Figure 7 The rear portion shown may be tapered. Instead of providing multiple holes, the rear portion 40c" may be provided with a side hole 41c" in the thicker portion of the rear portion 40c". The side hole 41c" may be adapted to be provided with an axis (not shown) that allows the flexible member 40" to rotate relative to the linkage element or actuator.

[0122] FIG. 3A to FIG. 3C A side view of another exemplary embodiment of a prosthesis or orthosis according to the present invention is schematically shown. In these three figures, the prosthesis or orthosis includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal body. The hinge joint system includes: a first member 310; a second member 320 pivotally attached to the first member 310; a connecting rod element or actuator 330 connected to the first member 310; a flexible member 340, which is connected to the second member 320 at a first end and to the connecting rod element or actuator 330 at a second end.

[0123] The first member 310 can be configured to be attached to a limb of a user. The first member 310 is pivotally coupled to the second member 320 about an axis A1. FIG. 3A to FIG. 3C In the embodiment of , the linkage element or actuator 330 is pivotally coupled to the flexible member 340 about a second second axis A2". The second second axis A2" is substantially parallel to the first axis A1. The linkage element or actuator 330 is also pivotally coupled to the first member 310 about a first second axis A2'.

[0124] exist FIG. 3A to FIG. 3C In an embodiment of the prosthesis or orthosis, the prosthesis or orthosis further comprises a first contact reinforcing element 351 and a second contact reinforcing element 352 configured to contact or enter into contact with the flexible member 340 and configured to provide a leverage along the length of the flexible member 340 so that the hinge stiffness between the first member 310 and the second member 320 varies. The first contact reinforcing element 351 and the second contact reinforcing element 352 are coupled to the flexible member 340 above the flexible member 340.

[0125] exist Figure 3A In the neutral (or resting) position of the prosthesis or orthosis in the embodiment of the present invention, the first contact reinforcing element 351 and the second contact reinforcing element 352 are at a distance from the flexible member 340. Compared with the first contact reinforcing element 352, the second contact reinforcing element 352 is disposed at a greater distance from the flexible member 340. Compared with the second contact reinforcing element 352, the first contact reinforcing element 351 is disposed closer to the front of the second member 320.

[0126] exist Figure 3B In the embodiment, the flexion movement between the first member 310 and the second member 320 causes the flexible member 340 to contact the first contact reinforcement element 351. When the first contact reinforcement element 351 contacts the flexible member 340, the first contact reinforcement element 351 causes the flexible member 340 to deform upward. The hinge stiffness around the first axis A1 increases.

[0127] exist Figure 3C In the embodiment of the present invention, the flexion movement between the first member 310 and the second member 320 is performed until the flexible member 340 contacts the second contact reinforcing element 352. When contacting the flexible member 340, both the first contact reinforcing element 351 and the second contact reinforcing element 352 cause the flexible member 340 to deform upward. The hinge stiffness around the first axis A1 is further increased.

[0128] FIG. 4A to FIG. 4CA side view of another exemplary embodiment of a prosthesis or orthosis according to the present invention is schematically shown. In these three figures, the prosthesis or orthosis includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal body. The hinge joint system includes: a first member 410; a second member 420 pivotally coupled to the first member 410; a connecting rod element or actuator 430 connected to the first member 410; a flexible member 440, which is connected to the second member 420 at a first end and to the connecting rod element or actuator 430 at a second end.

[0129] The first member 410 can be configured to be attached to a limb of a user. The first member 410 is pivotally coupled to the second member 420 about an axis A1. FIG. 4A to FIG. 4C In the embodiment of the present invention, the linkage element or actuator 430 is pivotally coupled to the flexible member 440 about a second second axis A2". The second second axis A2" is substantially parallel to the first axis A1. The linkage element or actuator 430 is also pivotally coupled to the first member 410 about a first second axis A2'.

[0130] exist FIG. 4A to FIG. 4C In an embodiment, the prosthesis or orthosis further includes a first contact reinforcing element 451 and a second contact reinforcing element 452, which are configured to contact or enter into contact with the flexible member 440, and are configured to provide a leverage along the length of the flexible member 440 so that the hinge stiffness between the first member 410 and the second member 420 varies. The first contact reinforcing element 451 is coupled to the first member 410 above the flexible member 440, and the second contact reinforcing element 452 is coupled to the second member 420 below the flexible member 440.

[0131] exist Figure 3A In the neutral (or resting) position of the prosthesis or orthosis in the embodiment of the present invention, the first contact reinforcing element 451 is at a distance from the flexible member 440, while the second contact reinforcing element 452 is in contact with the flexible member 440. The second contact reinforcing element 452 is closer to the front of the second member 420 than the first contact reinforcing element 451. In an alternative embodiment, the first contact reinforcing element 451 is in contact with the flexible member 440, while the second contact reinforcing element 452 is at a distance from the flexible member 440.

[0132] exist Figure 4B In the embodiment of the present invention, the flexion movement between the first member 410 and the second member 420 causes the flexible member 440 to contact the first contact reinforcing element 451. When the first contact reinforcing element 451 contacts the flexible member 440, the first contact reinforcing element 451 causes the flexible member 440 to deform upward. The hinge stiffness around the first axis A1 increases.

[0133] exist Figure 4C In the embodiment of FIG. 4 , the extension movement between the first member 410 and the second member 420 has been performed from the neutral position while the flexible member 440 has been in contact with the second contact reinforcing element 452. When the extension movement is performed in contact with the flexible member 440, the second contact reinforcing element 452 causes downward deformation of the flexible member 440. The hinge stiffness around the first axis A1 increases relative to the neutral position.

[0134] FIG. 5A to FIG. 5B Simple schematic diagrams of exemplary embodiments of a foot prosthesis or orthosis and a knee prosthesis or orthosis according to the invention are shown respectively.When implementing a hinge joint system, the mechanical basis requires a pivot connection between a first member 510 and a second member 520 about a main axis A1.

[0135] exist Figure 5A In the embodiment of , the first member 510 is provided with an attachment to the tibia, the second member 520 corresponds to the foot, and the main axis A1 represents the ankle joint. Figure 5B In the embodiment of the present invention, the first component 510 is provided with an attachment to the femur and the second component 520 is provided with an attachment to the tibia, and the main axis A1 represents the knee joint.

[0136] Furthermore, parallel to this pivot connection about the main axis A1, a link element or actuator 530 coupled to a flexible member 540 is arranged in series between the first member 210 and the second member 520. The combination of a link element or actuator 530 coupled to a flexible member 540 allows adjusting the torque between the first member 510 and the second member 520 about the main axis A1. In principle, between each element of the hinge joint system, i.e. between the first member 510 and the link element or actuator 530, between the link element or actuator 530 and the flexible member 540, and / or between the flexible member 540 and the second member 520, the connection 560 can be a pivot connection, but not necessarily about an axis substantially parallel to A1, or can be a fixed connection. Figure 5A In the embodiment, the flexible member 540 is arranged closer to the foot. Figure 5B In the embodiment of the present invention, the flexible member 540 is arranged closer to the femur.

[0137] In addition, the hinge joint system includes at least one contact strengthening element 550. The at least one contact strengthening element 550 is configured to contact or enter into contact with the flexible member 540 and is configured to provide a leverage effect along the length of the flexible member 540 so that the hinge stiffness between the first member 510 and the second member 520 changes. FIG. 5A to FIG. 5B In both embodiments, at least one contact strengthening element 550 is coupled to the second member 520 .

[0138] Figure 6 It shows that according to the present invention Figure 1 A perspective view of a second member of a prosthetic or orthotic embodiment of the invention. Figure 6 In the embodiment of the invention, the second member 20 is defined by a bottom panel 21 interconnected with two side wings 22, preferably made of a rigid material, such as metal or a composite material (such as carbon). In addition, the side wings 22 are generally triangular in shape to approximate the shape of a foot, and each side wing is provided with an opening 26. Figure 6 In the embodiment of the present invention, the two side wings 22 are extended and joined at the front of the second member 20, thereby improving the structural integrity of the second member.

[0139] One or more fixing holes 29 are configured to cooperate with a coupling device (not shown) to achieve fixing of the flexible member (not shown) to the second member 20. One or more fixing holes (29) may be provided at the front of the bottom panel 21. At the rear of the bottom panel 21, an opening may be formed in order to lighten the second member 20.

[0140] The fixing of the flexible member can be completed by a bracket and a coupling device (e.g., a bolt). The recess formed in the bottom surface of the bottom panel 21 can be used to hide the protruding part of the coupling member, such as the bolt head. Alternatively or additionally, the coupling device can include a bracket, a clamp, a bolt, a bracket and / or a chemical adhesive.

[0141] The side wings 22 may extend substantially vertically relative to the bottom panel 21 on both sides of the bottom panel 21. A pair of axial grooves 27 may be provided at the upper portion of the side wings 22. The pair of axial grooves 27 may be used to pivotally couple a first member (not shown) to the two side wings 22. The first axis A1 is defined thereby. Below the pair of axial grooves 27, a central structural element 28 may be provided to improve the structural integrity of the second member 20. When the central structural element 28 is installed in a prosthesis or orthosis, the central structural element 28 may be located above the flexible member. At least one contact reinforcing element (not shown) may be fixed to the central structural element 28.

[0142] FIG. 9A to FIG. 9B A top perspective view of another exemplary embodiment of a flexible member according to the invention and a top perspective view of yet another exemplary embodiment of a prosthesis or orthosis according to the invention are shown, respectively.

[0143] Fig. 9AA top perspective view of another exemplary embodiment of a flexible member according to the present invention is depicted. The flexible member 40'" includes a front portion 40a'", a middle portion 40b'", and a rear portion 40c'". The average cross-section per unit length of the middle portion 40b'" includes less material than the average cross-section per unit length of the front portion 40a'" or the rear portion 40c'". More specifically, in Fig. 9A In the embodiment, the thickness of the middle portion 40b'" is smaller than the thickness of the front portion 40a'" and the thickness of the rear portion 40c'". When viewed along the length direction of the flexible member 40'", the flexible member 40'" has a constant width.

[0144] exist Fig. 9A In an embodiment, both the rear part 40c'" and the front part 40a'" can be provided with a plurality of holes 41a'", 41c'", two holes 41c'" in the rear part 40c'" and four holes 41a'" in the front part 40a'", configured to cooperate with a connecting device (not shown), for example, with a corresponding plurality of bolts. The U-shaped opening 42c'" in the rear part 40c'" can allow the end of a connecting rod element or actuator (not shown) to be arranged therein to improve compactness.

[0145] In addition, Fig. 9A In the embodiment of the present invention, the flexible member 40a'" includes a buffer layer 43'". The buffer layer 43'" is configured to contact with at least one contact strengthening element (in Fig. 9B In the embodiment, it refers to 50') for contact. Fig. 9A In an embodiment, the buffer layer 43'" includes rubber, which is made of a single layer of constant thickness disposed on the top surface of the middle portion 40b'". In other embodiments, the buffer layer 43'" may include at least two layers of different materials. Additionally or alternatively, the shape and / or thickness and / or density distribution of the buffer layer 43'" can be customized to provide different buffering characteristics during contact between the flexible member 40'" and at least one contact strengthening element 50'.

[0146] exist Fig. 9B In an embodiment, a method very similar to Figure 1 The foot prosthesis of the embodiment uses Fig. 9A The flexible member has at least one different contact strengthening element 50'.

[0147] The prosthesis or orthosis includes a hinge joint system for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal body. The hinge joint system includes: a first member 10; a second member 20 pivotally attached to the first member 10; a link element or actuator 30 connected to the first member 10; a flexible member 40'", which is at a first end ( Fig. 9B The at least one contact reinforcing element 50' is configured to come into contact with the flexible member 40'" during use of the prosthesis or orthosis and to provide leverage along the length of the flexible member 40'". The at least one contact reinforcing element 50' allows the hinge stiffness between the first member 10 and the second member 20 to change when coming into contact. Fig. 9A In an embodiment, at least one contact strengthening element 50' and the flexible member 40'" are unbound.

[0148] The first member 10 may be configured to be attached to a limb of a user, such as the tibia for a trans-tibial foot prosthesis. The first member 10 is pivotally coupled to the second member 20 about an axis A1. Fig. 9B In the embodiment, the linkage element or actuator 30 is pivotally coupled to the flexible member 40'" about a second second axis A2". The second second axis A2" is substantially parallel to the first axis A1. The linkage element or actuator 30 is also pivotally coupled to the first member 10 about a first second axis A2', which is also substantially parallel to the first axis A1.

[0149] exist Fig. 9B In one embodiment, at least one contact reinforcement element 50' is integrated into the second member 20. More specifically, at least one contact reinforcement element 50' extends transversely between the two side wings 22 of the second member, thereby improving the structural integrity of the second member 20. In another embodiment, the at least one contact reinforcement element 50' is attached to the second member 20, for example, between the two side wings 22 of the second member.

[0150] At least one contact reinforcing element 50' protrudes downwards in the direction of the flexible component 40'". Facing the at least one contact reinforcing element 50', the flexible component 40'" is provided with a cushioning layer 43'". The at least one contact reinforcing element 50' and the cushioning layer 43'" of the flexible component 40'" will come into contact during the extension movement of the prosthesis.

[0151] In another embodiment, the buffer layer 43'" may include one or more elastic materials (e.g., silicone, rubber) stacked or arranged in one or more layers. Additionally or alternatively, a combination of different shapes may be used to implement the buffer layer 43'" depending on the change profile required for the hinge stiffness change.

[0152] FIG. 10A to FIG. 10B Two different side views of an exemplary embodiment of a foot prosthesis or orthosis with a movable contact reinforcement element according to the invention are schematically shown.

[0153] exist Fig. 10A and Fig. 10B In the two figures, the prosthesis or orthosis includes a hinge joint system for functionally assisting, enhancing and / or replacing the hinge joint system of a human or animal body. The hinge joint system includes: a first member 1010; a second member 1020 pivotally attached to the first member 1010; a connecting rod element or actuator 1030 connected to the first member 1010; and a flexible member 1040 connected to the second member 1020 at a first end and to the connecting rod element or actuator 1030 at a second end.

[0154] The first member 1010 can be configured to be attached to a limb of a user. The first member 1010 is pivotally coupled to the second member 1020 about an axis A1. FIG. 10A to FIG. 1 In the embodiment of 0C, the linkage element or actuator 1030 is pivotally coupled to the flexible member 1040 about a second second axis A2". The second second axis A2" is substantially parallel to the first axis A1. The linkage element or actuator 1030 is also pivotally coupled to the first member 1010 about a first second axis (not shown).

[0155] exist Fig. 10A In the embodiment, the prosthesis or orthosis further comprises a first movable contact reinforcing element 1050a, Fig. 10B In an embodiment of the prosthesis or orthosis, the prosthesis or orthosis further comprises a second movable contact reinforcing element 1050b. Both the first movable contact reinforcing element 1050a and the second movable contact reinforcing element 1050b are configured to contact or enter into contact with the flexible member 1040, and are configured to provide a leverage along the length of the flexible member 1040 so that the hinge stiffness between the first member 1010 and the second member 1020 changes. More specifically, both the first movable contact reinforcing element 1050a and the second movable contact reinforcing element 1050b are configured to be movable to a plurality of contact positions to provide a corresponding plurality of leverages along the length of the flexible member 1040.

[0156] exist Fig. 10A In an embodiment, a first movable contact reinforcing element 1050a is coupled to the second member 1020 above the flexible member 1040. The first movable contact reinforcing element 1050a may include a rotatable cam 1051 having an elongated profile and may be coupled to the first member 1010 via a pivot 1052. The pivot 1052 may have an axis of rotation that is substantially parallel to the axis A1. Depending on the angular positioning of the rotatable cam 1051, the leverage provided by the first contact reinforcing element 1050a may be made harder or less stiff by moving the point of contact between the rotatable cam 1051 and the flexible member 1040 closer to or further away from the midpoint along the length of the flexible member 1040. More specifically, in an embodiment such as Fig. 10AIn position 1 as shown, flexible member 1040 will have a stiffer response than in position 2.

[0157] exist Fig. 10B In the embodiment, the second movable contact strengthening element 1050b is also coupled to the second member 1020 above the flexible member 1040. The second movable contact strengthening element 1050b may include a sliding pin 1054 extending perpendicularly relative to the length of the flexible member. The sliding pin 1054 is configured to slide along the length of the flexible member 1040 toward or away from a midpoint, thereby moving the contact point between the sliding pin 1054 and the flexible member 1040. In order to guide the sliding pin 1054, an elongated guide device 1053, such as an elongated guide hole, may be provided in the second member. Fig. 10B In an embodiment, the elongated guide 1053 extends generally parallel to the length of the flexible member in the rest position.

[0158] In addition, the first movable contact reinforcing element 1050a and the second movable contact reinforcing element 1050b can be configured to move from a first contact position in a plurality of contact positions to a second contact position in a plurality of contact positions by means of motorized positioning actuators 1061, 1062. In order to move the rotatable cam 1051 of the first movable contact reinforcing element 1050a, a rotary motorized actuator 1061 can be used. In order to move the sliding pin 1054 of the second movable contact reinforcing element 1050b, a linear motorized actuator 1062 can be used. Preferably, when the flexible member 1040 is not in contact with the first movable contact reinforcing element 1050a and the second movable contact reinforcing element 1050b, respectively, the first movable contact reinforcing element 1050a and the second movable contact reinforcing element 1050b move from the first contact position to the second contact position. Those skilled in the art will appreciate that in other embodiments, a movable contact reinforcing member configured to move from a first contact position in a plurality of contact positions to a second contact position in a plurality of contact positions using both rotational motion and translational motion can also be implemented.

[0159] Although the principles of the present invention have been described above in conjunction with specific embodiments, it should be understood that such description is made by way of example only and is not intended to limit the scope of protection determined by the appended claims.

Claims

1. A prosthesis or orthosis, comprising a hinge joint system, for functionally assisting, enhancing and / or replacing a hinge joint system of a human or animal subject, the hinge joint system comprising: - a first component (10); - a second member (20) pivotably attached to said first member (10); - a linkage element or actuator (30) connected to said first member (10); - a flexible member (40) connecting the second member (20) and the linkage element or actuator (30); - at least one contact strengthening element (50) configured to contact or come into contact with the flexible member (40) and configured to provide leverage along the length of the flexible member (40).

2. The prosthesis or orthosis according to claim 1, wherein: At least one of the at least one contact strengthening element (50) is configured to contact or come into contact with the flexible member (40) during flexion or extension of the first member (10) relative to the second member (20).

3. A prosthesis or orthosis according to claim 1 or 2, wherein: At least one of the at least one contact reinforcing element (50) comprises a core (51) made of a first material and a cladding (52) surrounding the core made of a second material, wherein the second material has a greater elasticity than the first material.

4. A prosthesis or orthosis according to any one of the preceding claims, wherein: At least one of the at least one contact strengthening elements (50) is coupled to the second member (20); and / or wherein at least one of the at least one contact strengthening elements (50) is coupled to the first member (10).

5. A prosthesis or orthosis according to any one of the preceding claims, wherein: The flexible member (40) includes a leaf spring, and at least one of the at least one contact strengthening element is configured to provide a lever axis extending across a width of the flexible member (40).

6. A prosthesis or orthosis according to any one of the preceding claims, wherein: At least one of the at least one contact strengthening element (50) is mounted in a detachable manner.

7. A prosthesis or orthosis according to any one of the preceding claims, wherein: At least one of the at least one contact enhancing element (50) is movable to a plurality of contact positions to provide a corresponding plurality of lever actions along the length of the flexible member (40).

8. The prosthesis or orthosis according to claim 7, wherein: The at least one movable contact enhancing element (50) is configured to be moved from a first contact position of the plurality of contact positions to a second contact position of the plurality of contact positions by a motorized positioning actuator.

9. A prosthesis or orthosis according to any one of the preceding claims, wherein: The flexible member (40) is connected to the second member (20) at a front portion (40a) and to the linkage element or actuator (30) at a rear portion (40c).

10. The prosthesis or orthosis according to claim 9, wherein: The flexible member (40) includes the front portion (40a), the middle portion (40b) and the rear portion (40c); and In which, the average cross-section per unit length of the middle portion (40b) includes less material than the average cross-section per unit length of the front portion (40a) or the rear portion (40c), or includes more material than the average cross-section per unit length of the front portion (40a', 40a") or the rear portion (40c', 40c").

11. A prosthesis or orthosis according to claim 9 or 10, wherein: The front portion (40a) and the rear portion (40c) of the flexible member (40) are each provided with at least one hole configured to cooperate with a coupling device.

12. A prosthesis or orthosis according to any one of claims 9 to 11, wherein: The flexible component (40) is made in one piece.

13. The prosthesis or orthosis of claim 12, wherein: The flexible member (40) has a constant thickness when viewed along the length direction of the flexible member (40).

14. A prosthesis or orthosis according to claim 12 or 13, wherein: The flexible member (40) is flat.

15. A prosthesis or orthosis according to any one of the preceding claims, wherein: The flexible member (40) comprises a plate-shaped element or is composed of a plate-shaped element.

16. A prosthesis or orthosis according to any one of the preceding claims, wherein: The second member (20) is made of a rigid material.

17. A prosthesis or orthosis according to claim 16, wherein: The second member (20) is defined by a bottom panel (21) and / or a top panel and two side wings (22), wherein the bottom panel (21) and / or the top panel and the two side wings (22) are connected to each other; wherein the flexible member (40) is connected to the bottom panel or the top panel (21); wherein the two side wings (22) extend on both sides of the flexible member (40); as well as The first member (10) is connected to the two side wings (22).

18. A prosthesis or orthosis according to any one of the preceding claims, wherein: The flexible member further comprises a cushioning member configured to contact the at least one contact strengthening element, the cushioning member preferably being made of an elastic material.

19. A method for adapting a prosthesis or orthosis to a user, comprising: - obtaining the total weight and / or height of the user; - providing the user with the prosthesis or orthosis, the prosthesis or orthosis comprising a hinge joint system for functionally assisting, augmenting and / or replacing a hinge joint system of a human or animal body, the hinge joint system comprising a first member, a second member pivotably attached to the first member, and a linkage element or actuator connected to the first member; - Based on the acquired total weight and / or height, installing the flexible member in the prosthesis or orthosis by connecting the flexible member at a first end of the flexible member to the second member and at a second end of the flexible member to the linkage element or actuator.

20. The method according to claim 19, further comprising: Prior to installing the flexible member, the flexible member is tuned based on the acquired total weight and / or height.

21. The method according to claim 20, wherein: The tuning includes removing an amount of material from and / or adding an amount of material to the middle portion of the flexible member based on the acquired total weight and / or height.

22. The method according to any one of claims 19 to 21, further comprising: -Based on the acquired total weight and / or height, installing at least one contact reinforcement element in the prosthesis or orthosis, the at least one contact reinforcement element being configured to contact or enter into contact with the flexible member and configured to provide leverage along the length of the flexible member.

23. A method according to the preceding claim, wherein: Installing the at least one contact reinforcement element includes at least one of the following: adjusting the shape of the at least one contact reinforcement element, adjusting the constituent material of the at least one contact reinforcement element, adjusting the lateral positioning of the at least one contact reinforcement element, adjusting the number of the at least one contact reinforcement element, and adjusting the relative distance between the at least one contact reinforcement element and the flexible component in the rest position.

24. The method according to claim 22 or 23, further comprising providing the flexible member with a cushioning member, the cushioning member being configured for contacting the at least one contact strengthening element, wherein Optionally, the cushioning member is selected or designed based on the acquired total weight and / or height.

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