Apparatus and method for aligning prosthetic and orthotic components

Abstract

The joints of prostheses or orthotics are provided with reference features that visually indicate whether the joint is in a target position, such as a neutral position. A first reference feature and a second reference feature have a spatial relationship that varies based on the angles between the links of the joint. Alignment of the first and second reference features indicates that the joint is in a neutral position. Conversely, misalignment of the first and second reference features indicates that the joint is not in a neutral position.

Description

Technical Field

[0001] This disclosure generally relates to prosthetic devices and orthotic devices, and more specifically to joints for use in devices such as, but not limited to, prosthetic ankles / feet. This disclosure is directed to prosthetic joints and components intended for external use in the human body, and is meant to indicate that the disclosed devices are not intended for implantation in the human body. Background Technology

[0002] Lower limb prosthetic components must be aligned by a prosthetist to achieve their intended optimal function. In the case of the ankle / foot, the goal is to replicate a healthy human ankle / foot as closely as possible.

[0003] Industry-standard prosthetic connectors or adapters allow for angular adjustment in the coronal plane (rotation about an axis oriented anteroposteriorly) and sagittal plane (rotation about an axis oriented medially). Connectors that allow planar movement in the lateral plane also exist, but are typically heavier and more expensive. For example, a simple prosthetic leg typically consists of a prosthetic foot, a sham socket, and a strut that connects the prosthetic foot to the sham socket and determines the correct leg length. These components usually have prosthetic tapered adapters at their distal, proximal, or both ends. Precise alignment of the adjustable components is necessary to achieve the desired response of the prosthesis, meaning that the prosthetic components must be correctly oriented in space relative to the human body and other prosthetic components.

[0004] Prosthetic components with axes of motion present unique alignment challenges because movable parts can be oriented at arbitrary positions within the range of motion. This introduces another variable for amputees to achieve “correct” alignment. For example, prosthetic legs typically undergo two alignment phases. The first phase is “workbench alignment,” in which the prosthetist assembles the prosthetic leg using assembly jigs to meet the amputee’s needs. Workbench alignment is usually performed to reproduce a standing position. Further adjustments are made during the final alignment phase, which is conducted while the patient is using the prosthesis. This final alignment phase is often referred to as dynamic alignment. Dynamic alignment is conducted while the amputee is using the prosthesis under the supervision of a prosthetist. During dynamic alignment, the prosthetist adjusts the length and / or angle of components of the prosthesis based on training, experience, and feedback from the amputee to optimize the amputee’s gait. If the limb includes components with additional adjustable features such as adjustable stiffness, hydraulic resistance, and / or resistance timing, these features can also be adjusted. If the prosthetist fails to achieve near-optimal alignment during the workbench alignment, the problem may not be detected until the final alignment stage and may require significant work to correct, such as completely remanufacturing the socket or at least additional alignment components. This increases the cost and weight of the prosthesis and delays the amputee's access to the functional limb. Summary of the Invention

[0005] According to one aspect of some exemplary embodiments, one or more visual reference features are provided on one or more prosthetic components having at least one pivot axis of motion. Reference or alignment features for alignment, such as alignment marks, three-dimensional contours, or edges, allow prosthetists to orient the joint in the correct position within its range of motion during alignment procedures. Reference or alignment features facilitate the construction and alignment process of prosthetic joints employing components with a range of motion. Exemplary embodiments relate to a variety of joints, which may include, but are not limited to, prosthetic ankles, prosthetic feet, prosthetic knees, prosthetic hips, prosthetic elbows, prosthetic shoulders, and prosthetic wrists, or orthotic ankles, orthotic feet, orthotic knees, orthotic hips, orthotic elbows, orthotic shoulders, and orthotic wrists.

[0006] According to one aspect of some exemplary embodiments, a reference feature or alignment feature is provided on the prosthetic component of an ankle-foot prosthesis having a range of motion. The reference or alignment feature allows a prosthetist to orient the ankle / foot or knee joint to the correct position within the range of motion during both table alignment and final alignment. The reference or alignment feature facilitates the construction and alignment process of prostheses employing components with a range of motion.

[0007] Common prosthetic components with a pivoting axis of motion may have a limited range of motion. The component may also have an offset range of motion, in which one or more springs bias the orientation of a first component relative to a second component to a position located at one end of the range of motion. Alternatively, the first component may be biased to a position within the range of motion, but not at the end of the range. Some pivoting prosthetic components do not pivot about a stationary axis of rotation because they may be connected by linkage mechanisms, resulting in a moving axis of rotation, also referred to as an instantaneous center of rotation. Such prosthetic components are often described as multi-centered.

[0008] While using at least two reference features in combination is particularly useful for visually communicating when a prosthetic joint is in a neutral position, those skilled in the art will understand that the reference features according to this disclosure can be used to communicate other positions of the prosthetic joint. In particular, any position (e.g., a specific rotational / angular position or a specific longitudinal position) that cannot be easily and reliably determined by visual inspection alone, where no at least two reference features (also referred to as alignment features) explicitly provided for this purpose are available, can be advantageously communicated using such reference features according to this disclosure. This is generally most ideal for any position of the prosthesis required during the setting, alignment (by a prosthetist), calibration, and / or adjustment of the prosthetic joint.

[0009] In some embodiments, a joint assembly with a certain range of pivoting motion is forced to present and remain in a single target position within the range by using a temporarily placed or attached additional link. For example, the temporary alignment link may be a strut. In an exemplary ankle assembly, the strut may be attached or placed at the rear of the ankle. The strut is positioned or attached between two rotating components and sets an angular position as long as it remains in its in-place or attached position.

[0010] The following is an example method for aligning a prosthetic joint, the prosthetic joint including a joint assembly having a pivoting range of motion, the joint assembly including a first link rotatably connected to a second link such that the angle between the first link and the second link can vary between a minimum angle and a maximum angle, wherein the joint is configured to have a neutral position corresponding to a single angular measurement between the minimum angle and the maximum angle. The method may include placing the joint assembly in the neutral position by aligning a first reference feature on the first link with a second reference feature on the second link, wherein the first reference feature and the second reference feature have a spatial relationship that varies based on the angle between the first link and the second link, wherein alignment of the first reference feature and the second reference feature indicates that the joint is in the neutral position, and misalignment of the first reference feature and the second reference feature indicates that the joint is not in the neutral position. Alternatively, the joint assembly may be placed in the neutral position by temporarily attaching or positioning an alignment link of fixed length within an ankle assembly such that the joint assembly is fixed in a neutral position within the pivoting range of motion. After aligning the joint assembly to a single target location using any of these alignment techniques, the method may include the following further steps: performing one or more alignment procedures on the ankle-foot prosthesis while the alignment link is in the ankle assembly or the first reference feature and the second reference feature are aligned; and allowing the ankle assembly to move through the pivot range of motion by removing the alignment link or allowing the first reference feature and the second reference feature to be misaligned.

[0011] Exemplary embodiments may include, for example, one or more electromechanical components configured to confirm when a prosthetic or orthotic joint is in a neutral position. This confirmation may be an audible beep or a visual confirmation via an application on a device physically separated from and isolated from the prosthesis or orthosis. Some exemplary embodiments may provide confirmation / indication of neutral position / calibration via an indicator light source (e.g., one or more LEDs), which may be configured to change (e.g., illuminate, change color, change emission pattern, such as from constant light to flashing) to indicate neutral position or calibration. Some exemplary embodiments may provide confirmation / indication of neutral position / calibration via a built-in joint angle encoder, such as a Hall effect-based encoder that measures magnetic field strength and thus the distance between a sensor and a magnet.

[0012] Some exemplary embodiments may explicitly exclude any electronic and / or magnetic components (such as those listed in the preceding paragraphs) used to indicate or confirm when a joint assembly is in a neutral position. That is, some embodiments may contain no or any electromechanical components, audio components, lighting components, software components, digital components, processors (including microprocessors), external device application connectivity, joint angle encoders, and / or Hall effect sensors for indicating neutral position. It should be understood that elements of this type may or may not be included in the prosthesis or orthopedic device for purposes unrelated to indicating neutral or other angular positions. Regardless of the inclusion of specific electrical and / or magnetic components, an important aspect of many embodiments is a clear and simple visual indicator capable of reliably and intuitively conveying whether a joint assembly is in a significant position, particularly a neutral position, through naked-eye visual inspection. Neutral position can be determined solely by visual inspection of the physical prosthesis or orthopedic device, without the need for accessories such as computers / mobile applications or even power. The neutral rotational position (or alternative target position) of a joint cannot be determined visually (e.g., within a predetermined range of accuracy and precision) unless by means of reference features explicitly set for this purpose. The required level of certainty can be a tolerance of 0.1 degrees, 0.25 degrees, 0.5 degrees, 0.75 degrees, 1 degree, 1.25 degrees, 1.5 degrees, 1.75 degrees, 2 degrees, or other tolerance values ​​that differ from the true angle.

[0013] In some embodiments, the degree to which a joint is not in a neutral position can be visually communicated. Some users may benefit from a device that conveys, through simple visual information, whether the device is relatively close to or far from a neutral position. In some cases, this configuration may be superior to alternative devices that merely convey a binary state (e.g., whether the device is in a neutral position, without providing any further information about the degree or extent to which the device is not in a neutral position). Some exemplary embodiments can be configured to provide such further information about the degree or magnitude to which the device is not in a target position, such as a neutral position. Both a first reference feature and a second reference feature are simultaneously visible on the exterior of the prosthesis or orthosis and can be configured such that, as the joint (i) moves away from the neutral position and (ii) changes position toward the maximum and / or minimum angle of joint rotation, the physical space / gap / distance between the first reference feature and the second reference feature visibly increases in size (e.g., in a continuous or smooth transition manner). Similarly, the first and second reference features may also (or alternatively) be configured such that the physical space / gap / distance between the first and second reference features visibly decreases in size (e.g., in a continuous or smooth transition) as the joint (i) moves toward a neutral position and (ii) moves away from the maximum and / or minimum angle of joint rotation. At at least some angles within the stated angle range, both the first and second reference features are simultaneously visible externally from the ankle-foot prosthesis. In some embodiments, at least one of the first and second reference features may be obscured from the outside at specific angles, for example, at all rotational positions between the neutral rotational position and the rotational limit in the flexion direction, or at all rotational positions between the neutral rotational position and the rotational limit in the extension direction.

[0014] For the purposes of this disclosure, ankle flexion and dorsiflexion have the same meaning, and ankle extension and plantar flexion have the same meaning. Wrist flexion rotates the ventral side of the hand (palm) toward the ventral side of the forearm, and wrist extension rotates the dorsum of the hand (back of the hand) toward the dorsum of the forearm. Knee or elbow extension straightens the leg or arm, and knee or elbow flexion bends the knee or elbow.

[0015] In a joint with multiple links, each link can extend or retract to any of a plurality of different lengths, or be restricted to a single fixed length. Generally, any pair of links directly connected to each other can be configured to have exemplary reference features whose alignment indicates the joint is in a specific target position. The maximum angle that two connected links are allowed to form may correspond to the maximum flexion or maximum extension of the joint. The minimum angle that two connected links are allowed to form may correspond to the maximum extension or maximum flexion. For example, suppose three links are connected within a prosthetic joint to form a force triangle, then there are three angles in this triangle. When the joint flexes, the dimension of at least one angle in the force triangle increases, while the dimension of at least another angle decreases. When the joint extends, the dimension of at least one angle in the force triangle decreases, while the dimension of at least another angle increases. Therefore, whether a particular minimum angle value between a pair of links corresponds to the maximum or minimum angle of the entire joint depends on which pair of links is being discussed. Similarly, whether a particular maximum angle value between a pair of links corresponds to the maximum or minimum angle of the entire joint depends on which pair of links is being discussed. Attached Figure Description

[0016] Figure 1A It is a schematic diagram of a prosthetic or orthotic joint with at least two links.

[0017] Figure 1B It is a schematic diagram of a prosthetic or orthotic joint having at least three links arranged together to form a force triangle.

[0018] Figure 2A This is a schematic diagram of a joint, in which two connected links are at their maximum rotational distance from each other.

[0019] Figure 2B yes Figure 2A A schematic diagram of the joint, in which the two connected links are in a neutral position relative to each other.

[0020] Figure 2C yes Figure 2A A schematic diagram of a joint, in which two connected links are at their minimum rotational distance from each other.

[0021] Figure 3A It is a diagram of the typical gait cycle of a healthy, non-amputated adult human walking without the assistance of any prostheses or orthotics.

[0022] Figure 3B It is a curve of typical ankle torque during a normal gait cycle.

[0023] Figure 4 This is an exemplary prosthetic foot system, which includes a foot shell and a prosthetic foot.

[0024] Figure 5A , Figure 5B and Figure 5C These are stereoscopic images of an exemplary prosthetic foot from different perspectives.

[0025] Figure 5D yes Figures 5A-5C An exploded view of an exemplary prosthetic foot.

[0026] Figure 6A This is another exploded view, illustrating various alignment features of the exemplary prosthetic foot.

[0027] Figure 6B This is a perspective view of an exemplary prosthetic foot, which includes an ankle component, with alignment features appearing on the left side of the device.

[0028] Figure 7A This is an example prosthetic foot in the maximally dorsiflexed position.

[0029] Figure 7B It is a prosthetic foot in a neutral position.

[0030] Figure 7C It is a prosthetic foot in the position of maximum plantar flexion.

[0031] Figure 8A It is a prosthetic ankle assembly that is set to the target position by means of a temporary alignment link attached to the component.

[0032] Figure 8B It is a prosthetic ankle assembly that is set to the target position by a temporary alignment link located within the assembly.

[0033] Figure 9 This is an example of a prosthetic leg.

[0034] Figure 10 This is an exemplary prosthetic foot system in a neutral standing posture.

[0035] Figure 11 It is a prosthetic foot system in the maximum plantar flexion position, at which point the taper angle of the tapered connector is zero degrees.

[0036] Figure 12 It is a dummy foot system, in which the tapered connector is positioned at a tapered angle of two degrees.

[0037] Figure 13 It is a prosthetic foot system in the maximum dorsiflexion position, at which point the taper angle of the tapered connector is zero degrees. Detailed Implementation

[0038] Figure 1AThis is a schematic diagram of a prosthetic or orthotic joint 10. For the purposes of this disclosure, components or parts may be classified as "prosthetic," but it should be understood that exemplary embodiments are equally applicable to equivalent "orthotic" components or parts. Joint 10 includes a first component, particularly a first link 11, and a second component, particularly a second link 12. The first link 11 and the second link 12 are rotatably connected to each other at a pivot point 13. Joint 10 can belong to any prosthesis or orthosis that requires a certain range of rotational movement. For example, an exemplary prosthesis having joint 10 can replace a biological ankle, foot, knee, hip, elbow, shoulder, or wrist. An exemplary orthosis can support or relieve the load borne by one or more of the aforementioned joints.

[0039] Regardless of which type of biological joint the prosthesis is used to replace, the joint 10 allows rotation in both flexion and extension directions. As with biological joints, it may be desirable for the prosthetic or orthopedic joint 10 to have both flexion and extension limits, or alternatively, these limits may be a result of practical cost, weight, or other mechanical design constraints or design decisions. For this purpose, the joint 10 includes a first limiter 15 and a second limiter 16. Figure 1A In the figure, limiters 15 and 16 are schematically shown and may take any of a variety of different forms in different embodiments. The first limiter 15 is configured to establish a rotational limit that defines the minimum possible angle θmin between link 11 and link 12. The second limiter 16 is configured to establish a rotational limit that defines the maximum possible angle θmax between link 11 and link 12. Generally, joint 10 may be configured to allow the angle between link 11 and link 12 to be any angle value from θmin to θmax. For ease of illustration, Figure 1 uses a reference frame in which the first link 11 appears to be held in one position while the second link 12 rotates relative to the first link 11. Therefore, dashed line 17 shows the rotational position where the second link 12 can no longer move closer to link 11. When the second link 12 is in position 17, the angle between link 11 and link 12 is angle θmin. The dashed line 18 shows the rotational position where the second link 12 can no longer move away from the link 11. When the second link 12 is in position 18, the angle between the link 11 and the link 12 is angle θmax.

[0040] In the Earth's frame of reference, the flexion and extension of joint 10 may each involve only a change in position of the second link, or only a change in position of the first link, or both the first and second links may change position simultaneously. Regardless of the frame of reference, the angle between links 11 and 12 is limited to the range of θmin to θmax. Relative to the first link 11, during the use of the prosthesis or orthosis, the second link 12 may rotate to any rotational position between the limiters 15 and 16, and may also rotate away from said arbitrary rotational position.

[0041] Dashed line 14 illustrates a rotational position of particular importance, namely the neutral position 14, which is the angle between links 11 and 12 when joint 10 is in its neutral position. The neutral rotational position is angle θn. The neutral position of the prosthesis depends on the biological joint being replaced and the specific usage scenario, and can be equal to θmin or θmax. However, this disclosure is of particular concern to prostheses and orthotics where the neutral position is between the flexion and extension limits, i.e., θmin < θn < θmax. It is in this context that the specific problem outlined in the background section above becomes particularly prominent, namely, the difficulty in accurately determining the neutral position when aligning a prosthesis for a particular wearer.

[0042] In the context of prosthetic devices, the term "neutral position" refers to a specific resting or default position of an artificial joint. The neutral position can be the position where the prosthesis is not actively performing any specific movement or applying force. Neutral positions are typically designed to mimic the anatomical or natural resting position of the corresponding biological joint and related limb. For example, for a prosthetic arm, a neutral position of the relevant joint (which may include one or more of the shoulder, elbow, and wrist, depending on the range of the biological arm being replaced) positions the prosthesis beside the body, with the elbow slightly bent and the hand in a relaxed position. This position is usually chosen to provide a comfortable and natural appearance when the prosthesis is not actively used to perform a specific task or movement. The neutral position is important for several reasons. It allows the prosthesis to visually integrate with the user's body, making it look more natural and less conspicuous. Furthermore, the neutral position can serve as a starting point or reference for the user to initiate specific movements or gestures using the prosthesis. By returning to the neutral position after performing a task, the user can easily reset the position of the prosthesis. In some prostheses, the mechanical system can be configured to automatically return the prosthetic joint to a neutral position when the joint is not used to perform any task. In the context of ankle / foot prostheses, the neutral position is sometimes the standing position; that is, the angle θn required when the user is standing still with a portion of their weight (e.g., approximately half the user's body weight) applied to the ankle / foot prosthesis. The precise value of the neutral position angle θn depends in part on the specific construction of the prosthetic components. Generally, there is usually a single angular position that constitutes the neutral position of the joint. Therefore, in many cases (but not necessarily all), only a single neutral position exists. For the human ankle, the neutral or standing position results in the tibia forming a 4-degree angle relative to the vertical position, where the proximal end of the tibia is positioned anterior to the distal end (i.e., the tibia is tilted forward). Due to mechanical design trade-offs and historical context, the alignment orientation of prosthetic components may differ slightly from complete human anatomy. Significant deviations from historical norms can lead to customer confusion and complaints.

[0043] For ease of explanation, Figure 1A Joint 10 is depicted as having only a first link 11 and a second link 12. For various applications, prosthetic joint 10 may include one or more other links, particularly at least a third link. Depending on the application, the links of joint 10 may be of fixed length, variable length, or some combination of fixed-length and variable-length links.

[0044] Figure 1B Joint 10' is shown, and joint 10' is... Figure 1AThe joint 10 is basically the same, except that a third link 19 is added to connect the links 11 and 12 to each other. The third link 19 and the first link 11 are rotatably connected to each other at pivot point 21. The third link 19 and the second link 12 are rotatably connected to each other at pivot point 22.

[0045] One or more of links 11, 12, and 19 may be telescopic links. Telescopic links may also be interchangeably referred to as retractable links, or simply as variable-length links. An advantageous configuration suitable for some applications is that the first link 11 and the second link 12 are of fixed length, and a third link connected to both the first link 11 and the second link 12 is telescopic. Through the extension and retraction of the third / telescopic link 19, the third link 19 influences (or in some applications can even be configured to fully control) any variation in the angle between the first link 11 and the second link 12 within the range of θmin to θmax. Limiters 15 and 16 may be incorporated into the third link 19. For example, limiter 15 may set the minimum length to which the telescopic link can retract, while limiter 16 may set the maximum length to which the telescopic link can extend. The telescopic link may include, for example, a hydraulic cylinder or a linear actuator, or may be constituted by, for example, a hydraulic cylinder or a linear actuator. The stroke limit of the piston inside the hydraulic cylinder can be configured as limiters 15 and 16. The stroke limit can be defined by the end of the chamber that houses the piston.

[0046] According to some configurations, the first limiter 15 can be configured to establish a rotational limit in the flexion direction, while the second limiter 16 is configured to establish a rotational limit in the extension direction. In this context, dashed line 17 indicates the maximum flexion position of the second link 12. When the second link 12 is in position 17, the angle θmin between link 11 and link 12 is the maximum flexion angle. When the second link 12 is in position 18, the angle θmax between link 11 and link 12 is the maximum extension angle. However, in some embodiments, these descriptive terms can be interchanged. Depending on the overall construction of the prosthesis, angle θmin may correspond to the prosthesis joint in the maximum extension position, while angle θmax may correspond to the prosthesis joint in the maximum flexion position. Further examples below will illustrate this point more fully.

[0047] When referring to angles, those skilled in the art will understand that some prostheses and orthotics may have multiple pairs of components, each pair forming its own angle. Figure 1BThe arrangement of the links in joint 10' conveys that at any given static moment, links 11 and 12 form a first angle, links 12 and 19 form a second angle, and links 11 and 19 form a third angle. The values ​​of all three angles—the first, second, and third angles—can change as the length of the telescopic link 19 changes. One of these angles may or may not be an angle of the entire joint and / or the entire prosthesis. However, generally, when the joint is in a neutral position, the respective angles formed by the components movable relative to each other are also in their respective neutral positions. However, when the joint is in a neutral position, the numerical angles of the joint (expressed in degrees or radians) may be equal to or not equal to the numerical angles (expressed in degrees or radians) of any pair of links belonging to that joint. Generally, for exemplary embodiments of this disclosure, when two links are described as having a neutral angle / position between them, it can be inferred that other link pairs are simultaneously in their neutral angle / position, and the entire joint is in its neutral position. Conversely, when the joint is in its neutral position, the components within the joint are simultaneously in a rotational position relative to each other, referred to as its neutral position. Unless the context otherwise requires, the ankle angle of the joint is typically measured either from a purely vertical direction or from a horizontal direction (flat surface). The angular position of a link can be given relative to a purely vertical or horizontal direction, or relative to another link. The description of the figures above so far adopts the latter approach.

[0048] The exemplary embodiment addresses the problem of easily identifying, with high accuracy and repeatability, when a prosthetic joint, such as joints 10 and 10', is in its neutral position and when it is not. This is achieved, for example, by one or more specific reference features (e.g., visual markers) specifically designed for this purpose.

[0049] Figure 2A , Figure 2B and Figure 2C The figures show joints 10 or 10' of links 11 and 12 at their maximum angle θmax, neutral position θn, and minimum angle θmin, respectively. Features such as the third link and limiters are omitted to show certain other features more clearly. The first link 11 has a first reference feature 24, and the second link 12 has a second reference feature 25. (Comparison is provided.) Figure 2A , Figure 2B and Figure 2C It is evident that the first reference feature 24 and the second reference feature 25 have a spatial relationship that varies based on the angle between the first link and the second link. Figure 2BIn the neutral position of the joint shown, reference features 24 and 25 are aligned with each other. For the purposes of this schematic diagram, alignment means that the black dot (or the corner of physical component A carrying the black dot) coincides with the white circle (or the corner of physical component B carrying the white circle). From Figure 2A and Figure 2C It is evident that reference features 24 and 25 are misaligned at both the maximum and minimum angles of the joint. Reference features 24 and 25 are also misaligned at any other angle between links 11 and 12, except in the neutral position. Therefore, the alignment of the first reference feature 24 and the second reference feature 25 conveniently and clearly indicates that joint 10 / 10' is in the neutral position. Conversely, the misalignment of the first reference feature 24 and the second reference feature 25 indicates that joint 10 / 10' is not in the neutral position.

[0050] For joints with three or more links, such as Figure 1B Joint 10' generates multiple internal angles of the joint, and the reference feature can be applied to any combination of links. Figure 2B In this context, the two links should be understood as representing any pair of links rotatably connected to each other. Therefore, reference features such as features 24 and 25 can be applied respectively. Figure 1B The joint 10' of the connecting rods 11 and 12, or applied to Figure 1B The joint 10' of the connecting rods 11 and 19, or applied to Figure 1B The links 12 and 19 of joint 10'. Depending on the embodiment, one, two, or all three of these pairs may each have their own set of reference features.

[0051] Exemplary reference features may take many forms, including but not limited to markers (e.g., Figure 2A-2C (black dots and white circles) and / or the physical contours of a solid 3D structure (e.g., in...) Figure 2B (The physical corners of the physically connected and overlapping physical components A and B). Figure 2A-2C The schematic diagrams are intended to illustrate any of these options in a general sense. Further exemplary embodiments are described below, which illustrate available alternatives.

[0052] For illustrative purposes, an ankle / foot prosthesis will now be described having exemplary reference features for indicating when the prosthesis is in a neutral position and when it is not. In this context, some background knowledge of biological ankle / foot systems may be helpful.

[0053] Figure 3A and Figure 3BThis paper outlines the natural, fully biological behavior of the ankle / foot system in a typical adult human. A brief overview of common knowledge about the human gait cycle is helpful for understanding prostheses intended to replace the human ankle / foot system. Figure 3A It is a general representation of gait period. Figure 3B This is a graph showing the typical ankle moments during the gait cycle. The lowercase letter "n" in the graph indicates the neutral position of the ankle. The standing position can sometimes be considered the neutral position. In this disclosure, ankle angles may also be referred to as positions. Ankle angles in plantar flexion are indicated by the lowercase letter "p". Ankle angles in dorsiflexion are indicated by the lowercase letter "d". Thus, for example, "8p" is short for 8 degrees of plantar flexion. In contrast, "10d" is short for 10 degrees of dorsiflexion. Figure 3A The specific angle measurements provided are quite representative, representing the expected ankle angles during the gait cycle of healthy adults. However, individual differences exist, and therefore it should be understood that... Figure 3A The angles shown are for illustrative purposes only and are specifically chosen.

[0054] The human gait cycle is divided into two main phases described for each foot: (1) the support phase when the foot contacts the ground, and (2) the swing phase when the foot is in the air. Typically, when the left foot is in the support phase, the right foot is in the swing phase. Similarly, when the left foot is in the swing phase, the right foot is in the support phase. The support phase is divided into five sub-phases, and the swing phase is divided into three sub-phases. Figure 3A The shaded area represents a sub-phase of the support phase. Although the knee and hip joints are also involved in the gait cycle, the following brief discussion of the gait cycle will focus on the movement at the ankle-foot complex during the gait cycle.

[0055] The first sub-stage of the support phase is initial contact (in) Figure 3AThe initial contact (abbreviated as "IN.CT") occurs when the heel first touches the ground, accounting for the first 3% of the support phase. In some literature, initial contact is also referred to as heel strike; heel strike or initial contact can also be used to describe the moment the support phase begins. Following initial contact is the load response phase, which ends when the foot is fully flat on the ground. Fully flat on the ground generally corresponds to the toe-off event of the contralateral foot. During the initial contact and load response phases, the ankle plantarflexes approximately 8° (to 8p) from a neutral position (n), and the foot is fully in contact with the ground (also referred to as flat on the ground). In some embodiments, the neutral position may be interchangeably referred to as the standing position. Next is the mid-support phase, where the ankle moves from 8° plantarflexion (8p) to 5° dorsiflexion (5d). This is followed by the late support phase, which begins with heel lift ("heel off") and continues until 10° dorsiflexion (10d). The final sub-phase of the support phase is the pre-swing phase, during which the foot is preparing to leave the ground. During the early swing phase, the foot dorsiflexes from 10° (10d) to 20° (20p). The early swing phase ends with the foot leaving the ground (also known as "toe-off"). The peak ankle moment of the support phase occurs during the load response phase.

[0056] The swing phase is the phase in which the foot is in the air. It immediately follows the pre-swing phase and ends at the next initial contact. The first sub-phase of the swing phase is the initial swing. During the initial swing, the foot leaves the ground and moves upward as the knee flexes. The ankle returns from the plantarflexed position (20p) reached during the pre-swing to a roughly neutral position (n). The initial swing ends when the knee stops flexing (i.e., the knee reaches its maximum flexion position). At the end of the initial swing, the left and right feet are generally roughly adjacent to each other in the coronal plane, meaning neither foot is significantly further forward than the other. Next is the mid-swing. The mid-swing begins when the knee begins to extend and ends when the tibia is roughly vertical to the ground. During the mid-swing, the ankle is slightly dorsiflexed (approximately 2°, from n to 2d) to help the toes leave the ground. The final sub-phase of the swing phase is the final swing. During the final swing, the knee extends to near full extension, and the foot returns to a neutral position (n), preparing for the next initial contact.

[0057] Figure 3B This is a graph depicting the ankle torque of a healthy biological ankle / foot as a function of the gait cycle percentage. The ability of a prosthesis to closely reproduce or simulate this ankle torque variation depends primarily on two factors: ankle-foot design and prosthesis alignment.

[0058] Figure 4A perspective view of an example of a prosthetic foot system 100 is shown, which includes a foot shell 102 and a prosthetic foot 104. The prosthetic foot 104 is configured to support the user of the prosthetic foot system 100. The foot shell 102 is configured to accommodate and protect the prosthetic foot 104 and has an aesthetically pleasing design. The foot shell 102 provides an aesthetically pleasing overlay for the prosthetic foot 104, making it resemble a real foot in appearance. In some embodiments, the prosthetic foot 104 may be intended for use inside a shoe. The prosthetic foot system 100 is configured to be fitted to a limb (not shown), such as a residual limb after amputation. An example of a residual limb may be a residual limb associated with below-knee amputation. In some embodiments, the foot shell 102 may be formed as a single, integral device without any separate components. In other embodiments, the foot shell 102 and the prosthetic foot 104 may be formed as separate components and assembled after the foot shell 102 and the prosthetic foot 104 are formed. One or more of the foot shell 102 and the dummy foot 104, or components thereof, may be formed or manufactured via an additive manufacturing process (e.g., 3D printing) that forms the foot shell 102 and / or the dummy foot 104 from a three-dimensional lattice network. In some embodiments, the foot shell 102 may be omitted.

[0059] Figure 5A , Figure 5B , Figure 5C and Figure 5D These are various views of the prosthetic foot 104. To show the components of the prosthetic foot 104 more clearly, the illustration of the foot shell 102 is omitted from these figures. Figure 5A , Figure 5B and Figure 5C They are different 3D images, and Figure 5D This is an exploded view. The exemplary prosthetic foot 104 includes a spring assembly 116 and an ankle assembly 118.

[0060] An exemplary ankle assembly 118 includes a base 186, a telescopic link 188, and prosthetic adapter portions 190 that are pivotally attached to each other. The telescopic link may be, or at least includes, a hydraulic cylinder. The ankle assembly 118 may be, or include, a passive hydraulic damping system that provides damped rotational resistance to the ankle joint components, having independent and independently adjustable damping resistance in both plantar flexion and dorsiflexion directions.

[0061] Typically, the spring assembly 116 replaces the biological foot, and the ankle assembly 118 replaces the biological ankle. In use, these subsystems interact with each other, so the behavior and performance of the prosthetic foot 104 do not derive from just one of the subsystems, but specifically from their combination. That is, the two subsystems can be separable, so the foot spring assembly can be combined with different alternative ankle assemblies, and similarly, the ankle assembly can be combined with different alternative foot assemblies.

[0062] Spring assembly 116 includes a base spring 120, a top spring assembly 122, and a heel cushion 124. The spring assembly is rigidly and fixedly attached to a first side 182 of the base 186. The top spring assembly 122 is connected to the base spring 120 in the toe region via a toe-end connector 126. The toe-end connector 126 may include an adhesive connection formed, for example, by an adhesive. The toe-end connector 126 may be formed of an elastic, flexible material that allows for at least some relative movement between the base spring 120 and the top spring assembly 122 (e.g., rotational movement about a vertical axis, compression, and translational movement in the forward / backward and / or inward / outward directions). The toe-end connector 126 provides the sole connection point between the base spring 120 and the top spring assembly 122. Typically, the heel cushion 124 is mounted directly to the top surface of the base spring 120 and arranged to contact the bottom surface of the top spring assembly 122. The heel cushion 124 may be releasably attached to the base spring 120. Alternatively, the heel cushion 124 may be releasably connected to the top spring assembly 122. In at least some examples, the heel cushion 124 is interference-fitted to the base spring 120, for example, using a retainer 128 mounted to the top surface of the base spring 120. The heel cushion 124 may be replaced with other heel cushions having different characteristics, such as increased or decreased stiffness, compressibility, damping capacity, etc. Heel cushions of different sizes and shapes may also be used instead of the heel cushion 124 shown in the figures. In some examples, the dummy foot 104 may operate without any heel cushion 124.

[0063] Ankle assembly 118 is releasably attached to the proximal end of top spring assembly 122. In at least one example, ankle assembly 118 is releasably connected via one or more fasteners 130a, 130b. Prosthetic adapter portions with different connector features, such as tapered connector 132, may be used; for example, a female tapered adapter may replace a male tapered adapter 132. In at least some examples, tapered connector 132 is a replaceable component of ankle assembly 118. In other embodiments, tapered connector 132 is integrally formed with the remainder of the adapter assembly. In addition to tapered connectors, other connector features may be used as part of the adapter assembly to secure prosthetic foot 104 to another prosthetic component, such as a calf column, socket, etc.

[0064] The base spring 120 is shown including a toe end 134, a heel end 136, a sandal groove 138, and a balance groove 140. The base spring 120 may also include a top surface 142, a bottom surface 144, and a heel cushion retainer 128 located at the heel end portion of the base spring 120. The retainer 128 may include a cavity 146 and an edge 148 to help releasably secure the heel cushion 124 to the base spring 120.

[0065] The sandal groove 138 may also have a length Ls. The length of the sandal groove 138 is typically in the range of about 0.5 to about 2 inches. The sandal groove 138 is formed at the toe end portion of the base spring 120 and extends rearward from the innermost edge of the base spring 120. The balance groove 140 is also formed at the toe end portion and extends rearward from the foremost edge of the base spring 120. In at least some embodiments, the balance groove 140 is aligned with the longitudinal centerline of the base spring 120. The balance groove 140 enhances the inward and outward compliance of the prosthetic foot 104, especially when walking on uneven surfaces.

[0066] Such as at least Figures 5A-5C As shown, the base spring 120 has a profile shape along its length. The side profile of the base spring 120 undulates between concave and convex shapes. In some examples, the distal surface of the base spring 120 is preferably convex in the front section, transitions to concave in the arch or mid section, and may transition back to convex at the rear end. These profiles, and their positions, particularly relative to the toe connector 126 and the heel cushion 124, provide improved rolling smoothness, enhanced energy return to the user, stability, and comfort during use of the prosthetic foot. A lever portion extending behind the heel cushion 124 also provides improved rolling smoothness and energy return during use.

[0067] The top spring assembly 122 is shown as including a first spring member 150, a second spring member 152, a first spacer 154 located at the toe end portion of the prosthetic foot, a second spacer 156 located near the proximal end of the top spring assembly 122, and a gap G disposed therebetween the first spring member 150 and the second spring member 152 along their entire length. The first spring member 150 and the second spring member 152 may be referred to as leaf springs. The first spring member 150 and the second spring member 152 may extend substantially parallel to each other along their entire length. The first spacer 154 may be provided as an adhesive connection between the first spring member 150 and the second spring member 152. In at least some examples, the first spacer 154 includes the same adhesive material as the adhesive material used for the toe end connector 126 between the top spring assembly 122 and the base spring 120. In at least some embodiments, the first spacer 154 is substantially aligned with the toe end connector 126 so as to be vertically positioned above the toe end connector 126, or at least partially overlapping the toe end connector 126 in the length direction of the base spring 120. The first spacer 154 provides a permanent connection between the first spring member 150 and the second spring member 152. The material of the first spacer 154 allows for at least some relative movement between the first spring member 150 and the second spring member 152 (i.e., rotational movement about a vertical axis, translational movement in the front-back or inside-out direction, compression, etc.). The material of the first spacer 154 may be elastic so that it returns to its original shape when the force used to compress or deform the first spacer 154 is removed.

[0068] In other examples, the first spacer may comprise an abrasion-resistant, low-friction material attached to one of the first and second springs. The first spacer is not attached to or connected to the other of the first and second springs. This arrangement supports compressive forces between the distal ends of the first and second springs, allows the springs to separate during plantar flexion, and also allows the springs to slide against each other at their distal ends. This embodiment also alters the foot's performance during rolling compared to using the first spacer as an adhesive connection. Tensile and shear forces are not transmitted through the spacer, thus modifying the deflection and stress conditions in the upper spring assembly. During plantar flexion at heel strike, the first spring is unloaded, and as the foot rolls and the user's weight transfers to the toes, the shear displacement between the distal ends of the first and second springs causes increased deflection of the foot in the toe region, thereby softening the foot during the heel strike and late support phase of the gait cycle.

[0069] The second spacer 156 may comprise an incompressible and / or inelastic rigid material. The second spacer 156 may be located at the proximal end of the top spring assembly 122. The second spacer 156 may be aligned with the ankle assembly 118 or at least a portion thereof. In the illustrated embodiment, the second spacer 156 includes holes through which fasteners 130a, 130b extend to connect the ankle assembly 118 to the top spring assembly 122.

[0070] When the prosthetic foot 104 is at rest, the first spacer 154 and the second spacer 156 can define the size of the gap G. Typically, when the prosthetic foot 104 is at rest (i.e., before force is applied during use), the gap G is positioned along the entire length of the first spring member 150 and the second spring member 152. Alternatively, the two upper springs 150, 152 may be abutted at a connector location (e.g., in direct contact with each other). During operation of the prosthetic foot 104, the size of the gap G can vary. For example, if the material of the first spacer 154 is compressible during use, the size of the gap G at the first spacer 154 can be reduced. In another example, during use, the size of the gap G at the location between the first spacer 154 and the second spacer 156 can be reduced or changed. For example, the force applied by the user during the gait cycle can change the size of the gap G at various stages of the gait cycle (e.g., at heel strike, support phase, and toe lift), because the forces applied and released by the wearer are absorbed and / or fed back through the base spring 120 and the heel cushioning pad 124. In at least some embodiments, during use of the prosthetic foot, the first spring member 150 may contact the second spring member 152 (i.e., the gap is reduced to zero).

[0071] The first spring member 150 is shown having a front end 158, a proximal end 160, a horizontal portion 162, a slot 164, and fastener holes 166a, 166b. The second spring member 152 may include a front end 168, a proximal end 170, an inclined portion 172, a slot 174, and fastener holes 176a, 176b. The slot 174 may be aligned with the slot 164 of the first spring member 150 and the balancing slot 140 formed in the base spring 120. In at least some examples, the slots 140, 164, and 174 may extend rearward to a common position. The slots 140, 164, and 174 may terminate at different positions in a forward direction. The slots 164 and 174 may be aligned with the centerline of the base spring 120 and the top spring assembly 122 to provide balanced pronation and compliance during use of the prosthetic foot.

[0072] Such as at least Figures 5A-5C As shown, the top spring assembly 122 is mounted to the base spring 120. The heel cushioning pad 124 is arranged to be able to contact the bottom or downward-facing side or surface of the top spring assembly 122 (e.g., Figure 5CThe bottom surface of the first spring member 150 shown in the diagram is in contact with the heel cushion 124. Although the heel cushion 124 is shown attached to the base spring 120 rather than the top spring assembly 122, other embodiments may attach the heel cushion 124 to both the base spring 120 and the top spring assembly 122, or only to the top spring assembly 122 (e.g., a retainer 128 is mounted to the bottom surface of the first spring member 150 for releasably attaching the heel cushion 124).

[0073] The heel cushion 124 can be releasably mounted to the base spring 120 (or the top spring assembly 122). Alternatively, the heel cushion 124 can be permanently attached to the base spring 120. The replaceability of the heel cushion 124 allows for customization of the amount of heel stiffness, cushioning, energy damping, etc., provided by the heel cushion 124. The heel cushion 124 can be connected via an interference fit. Other embodiments may use a form-fit connection (e.g., fastener, clip, bracket, etc.) to secure the heel cushion 124.

[0074] Heel cushioning pad 124 may include top surface 178 (see Figure 5C It has a tapered shape with variable thickness along its length, a bottom surface 180, a top peripheral edge 182, and a bottom peripheral edge 184. The tapered shape allows for a greater thickness at the rear end of the heel cushioning pad 124 and a smaller thickness at the front end, such as... Figure 5C As shown. The tapered shape of the heel cushioning pad 124 can match the angle and / or curvature of the first spring member 150. Therefore, the top surface 178 can have a contour shape rather than a planar shape. Similarly, the bottom surface 180 can have a shape that matches the contour or curvature of the top surface of the base spring 120, such as at least Figure 5C As shown.

[0075] The heel cushioning pad 124 may include shock-absorbing, damping materials, such as silicone or polyurethane elastomers, including, for example, silicone or polyurethane foam. In some embodiments, the heel cushioning pad 124 may include a variety of different materials, material layers, or individual components that are fixed together as an assembly to provide desired cushioning properties. In one example, the heel cushioning pad 124 includes foam material encapsulated within a protective polymer shell. In another example, the heel cushioning pad 124 includes a gel material or capsule encapsulated within the foam material.

[0076] The base spring 120, the first spring member 150, and the second spring member 152 may comprise fiber-reinforced composite materials, such as carbon fiber reinforced composite materials. The first spacer 154 may comprise an adhesive bond, which includes a flexible adhesive, such as a polyurethane adhesive with a Shore A hardness in the range of about 70 to about 95. During the manufacture of the top spring assembly 122, a removable gasket between the springs may be used to create a sealed space for the adhesive, and then the adhesive is injected into the space to bond the first spring member 150 and the second spring member 152 together.

[0077] The length of the second spring member 152 may be shorter than the length of the first spring member 150. This length difference allows for a gradual change in the stiffness of the top spring assembly 122. Although two spring members 150, 152 are shown as part of the top spring assembly 122, other embodiments may utilize more than two leaf spring elements, and the leaf spring elements may have the same or different lengths.

[0078] The second spacer 156 may comprise a lightweight material, such as aluminum, nylon, or fiberglass sheet (e.g., fiberglass G-10). The top spring assembly 122 may provide a connection between the opposite ends of the first spring member 150 and the second spring member 152, and provide a gap G between them, thus offering numerous unexpected structural advantages. These advantages, associated with the type of spacers 154, 156, the toe-end connector 126, the heel cushioning pad 124, and / or other features, offer numerous performance advantages compared to known prosthetic feet. For example, a double narrow cantilever beam (one above the other, with space between the upper and lower beams, and frictionless spacers at the free ends to transfer applied vertical forces from the upper beam to the free ends of the lower beam) can result in a reduction of approximately 15-25% in bending stress and approximately 30-45% in shear stress compared to a single cantilever beam with equivalent stiffness. If the first spacer comprises a low-friction material attached to one of the first and second springs, the described boundary conditions are highly accurate.

[0079] If the first spacer is bonded (e.g., formed of a flexible material), the boundary conditions are generally between a frictionless spacer between the distal ends of the first and second springs and a rigid connection at the distal ends of the first and second springs. Because stress is reduced by using a double-upper-spring design, the dummy foot utilizing this double-spring design exhibits at least one of improved durability and improved flexibility compared to a single-spring design and a double-spring design with a rigid connection at the distal ends. Furthermore, the use of a low-friction spacer material provides greater flexibility compared to using a flexible bonded connection, thus potentially offering opportunities to achieve different and desired performance characteristics, as well as a variety of design options to achieve the designer's objectives. Many advantages of the double cantilever beam design disclosed herein are maximized when the two beams (e.g., the first spring member 150 and the second spring member 152) have substantially equal bending stiffness. The maximum strength / stiffness ratio is optimally achieved when the beams are composed of unidirectional fiber-reinforced composite laminates, provided that the two beams have substantially the same laminate orientation and thickness. The advantages of the double cantilever spring design generally diminish as the difference in bending stiffness between the upper and lower beams increases.

[0080] The heel cushion 124 may comprise a silicone or polyurethane elastomer (e.g., an elastomer with a Shore hardness ranging from about 50 A to about 90 A). The heel cushion 124 may be held in place by a retainer 128 extending around the entire periphery of the heel cushion 124. Other embodiments may provide a retainer extending only around a portion of the periphery of the heel cushion 124. The retainer 128 may be bonded to the top surface 142 of the base spring 120, for example, with an adhesive. In some embodiments, both the adhesive and the retainer 128 have a degree of flexibility to prevent the retainer 128 from separating from the base spring 120 when the base spring 120 bends during use. The retainer 128 and the adhesive may comprise a plastic material with a Shore hardness ranging from about 90 A to about 50 D, for example. Alternatively, the retainer 128 may be cast into the structure of the base spring 120 along its top surface 142, which eliminates the need for adhesives or other bonding agents.

[0081] The retainer 128 can help hold the heel cushion 124 in place by utilizing geometrically interlocking features. These interlocking features may include angled (e.g., wedge-shaped) features within the retainer and along the exterior of the heel cushion 124, wherein the corresponding surfaces interact to provide a connection. To fit the heel cushion 124 into the interior of the retainer 128, the heel cushion 124 may be deformed or compressed and then automatically expanded to its original shape, thereby forming an interference fit connection between the features of the retainer 128 and the heel cushion 124. Alternatively, the retainer 128 and the heel cushion utilize ribs fitted into recesses, wherein ribs and recesses may be formed on either the retainer 128 or the heel cushion 124.

[0082] Typically, the base spring 120 extends from the toe region of the prosthetic foot to the heel region. The base spring 120 can extend from the innermost point of the prosthetic foot 104 to the outermost point of the prosthetic foot 104. The top spring assembly 122 can be connected to the base spring 120 at a rearward location spaced apart from the foremost edge of the base spring 120. In at least one example, the top spring assembly 122 is located behind the sandal groove 138 formed at the distal end of the base spring 120. The base spring 120 can extend forward at least as far as the foremost point of the length of the top spring assembly 122.

[0083] As discussed above, the slots or slits 140 formed in the base spring 120 in a rearward direction from the front edge can be aligned with the slots or slits 164, 174 formed in the top spring assembly 122 extending rearward from the front end of the top spring assembly 122. These slots or slits allow the entire prosthetic foot 104 to be divided into medial and lateral sides, at least in the toe and midfoot regions of the prosthetic foot.

[0084] The top spring assembly 122 includes a first spring member 150 and a second spring member 152 extending along the length of the prosthetic foot to different forward positions. At least Figure 5C The first spring member 150 extends further in the forward direction than the second spring member 152. The first spacer 154 is located at the foremost edge of the second spring member and is spaced rearward from the foremost edge of the first spring member 150.

[0085] The top spring assembly 122 extends generally parallel to the base spring 120 in the toe, midfoot, and heel regions of the base spring 120. As described above, other embodiments may provide that the top spring assembly 122 continues to extend in a generally horizontal or slightly angled direction relative to the base spring 120 and / or through the horizontal plane of the heel end portion.

[0086] Furthermore, when the dummy foot 104 is at rest or without load, the gap G can be substantially constant. During use of the dummy foot 104, portions of the first spring member 150 and the second spring member 152 can move toward and / or away from each other to change the size of the gap G at various locations along the length of the top spring assembly 122. In at least some embodiments, portions of the first spring member 150 and the second spring member 152 can contact each other.

[0087] Fasteners 130a-b can be arranged side-by-side in the inward and outward directions. In other arrangements, fasteners 130a-b can be arranged aligned along the length of the dummy foot 104. Although Figure 5COnly two fasteners 130a-b are shown, but one or more fasteners 130a-b may be used. Fasteners 130a-b may provide a form-fit connection between the first spring member 150 and the second spring member 152, a form-fit connection between the top spring assembly 122 and the ankle assembly 118, and / or a form-fit connection between one or both of the first spring member 150 and the second spring member 152 and the spacer 156. In some examples, fasteners 130a-b may be directly connected to one or both of the first spring member 150 and the second spring member 152 (e.g., to a threaded seat formed in one or both of the first spring member 150 and the second spring member 152), or may be connected to a nut (not shown) located on the opposite side of the top spring assembly 122.

[0088] The dummy foot 104 can provide a spring member spaced apart from the spring member used in the top spring assembly 122, arranged in a specific position and having Figure 5C The shapes and sizes of the heel cushioning pad 124, the top spring assembly 122, and the base spring 120, as well as the dimensions, shape, and orientation of the ankle assembly 118, are associated with energy feedback, stability, force damping, etc. Furthermore, the base spring 120 and the top spring assembly 122 may include slots (e.g., slot 140 for the base spring 120 and slots 164, 174 for the first spring member 150 and the second spring member 152), which provide the prosthetic foot 104 with pronation, supination, and walking ability, thereby providing improved stability for the user, especially on uneven surfaces.

[0089] Prosthetic foot 104 can be a two-toe spring or a multi-toe spring prosthetic foot. Prosthetic foot 104 can also be a single-toe spring prosthetic foot. The heel assembly, adapter assembly, attachment assembly, and other features disclosed herein with reference to any single disclosed embodiment are interchangeable with features of other prosthetic foot embodiments disclosed herein.

[0090] In an alternative embodiment, the connection between the base spring and the top spring assembly, and the connection between the first spring member and the second spring member in the front region of the foot, can be provided by bolts or other fasteners. Rigid spacers can be provided between the spring members and / or between the top spring assembly and the base spring. At the connection point at the front of the prosthetic foot, gaps that might otherwise exist can be eliminated by using bolts or other fasteners in conjunction with altered geometries of the first and second spring members. In another embodiment, the connection between the first and second spring members can be formed by wrapping carbon fiber or glass fiber around the first and second spring members at the connection point between them, and by securing the spring members and fibers with epoxy resin or a similar thermosetting resin. A similar connection can be formed between the top spring assembly and the base spring.

[0091] In another example, the connection at the proximal end of the top spring assembly can be formed by changing the geometry of the first and second spring members, such that there is no gap at the connection point between the first and second springs. In this arrangement, gaps may still be provided between the first and second spring members at other locations along their lengths. In some embodiments, one or more of the first and second spring members may be inserted into a slot formed in a prosthetic connector (e.g., the base 186 of the ankle assembly 118), and the first and second spring members are secured together and fixed to the prosthetic connector by adhesives or fasteners.

[0092] Now let's discuss Figures 5A-5DThe exemplary ankle assembly 118 shown is illustrated. As briefly mentioned above, the exemplary ankle assembly 118 includes a base 186, a telescopic link 188, and prosthetic adapter portions 190 that are pivotally attached to each other. The ankle assembly 118 provides a more natural feel to the user during the gait cycle. During normal use, the ankle assembly 118 provides amputees with a fluid-like movement, rather than the more rigid feel associated with a typical prosthetic foot. Specifically, an exemplary ankle assembly may include one or more (up to all) of the following features: (1) a dorsiflexion limiter that restricts dorsiflexion rotation of the ankle assembly, transferring load to a composite spring located in the forefoot region of the foot assembly, allowing the composite spring to provide support and store energy; (2) a soft dorsiflexion limiter that improves the transition between hydraulic resistance and spring resistance generated by the composite foot spring element; (3) a manual hydraulic lock that prevents plantarflexion of the ankle, such that the ankle is locked when it reaches maximum dorsiflexion; (4) a volumetric compensator that maintains the hydraulic system at a preloaded pressure on the fluid and compensates for fluid loss; (5) a hydraulic lock that can lock the ankle in any position to allow the user to use the same prosthetic ankle and foot for different heel heights (shoes); (6) improved hydraulic geometry; and (7) one or more springs configured to store energy during plantarflexion rotation of the ankle assembly and release the stored energy during dorsiflexion rotation of the ankle assembly. In some embodiments, some of these features may be omitted.

[0093] The improved hydraulic geometry may require positioning the ankle pivot point so that a high percentage of axial load is supported by the pivot structure when the user is standing. Furthermore, the hydraulic cylinder has improved leverage around the base and foot spring pivot point, reducing the pressure of the hydraulic fluid in the system and decreasing the required strength and mass of the hydraulic cylinder. The resulting advantages also include increased cycle life and seal integrity.

[0094] The exemplary ankle component 118 enables the prosthetic foot 104 to perform plantar flexion and dorsiflexion movements. Achieving plantar flexion at the ankle joint allows the metatarsophalangeal (ball) region of the foot to contact the ground earlier during the gait cycle. The wider portion of the ball / foot provides stability during the gait cycle. The ankle component 118 also enables a small amount of dorsiflexion relative to the standing position, which, compared to a prosthetic foot without an ankle component, results in reduced and adjustable resistance to anterior tibial displacement when the prosthetic lower leg is vertical or nearly vertical. When the amputee's center of gravity is directly above the lower leg and the lower leg is vertical, the amputee does not experience significant leverage on the lever arm generated by the forefoot of the prosthetic foot. The ankle component 118 alleviates this limitation of the prosthetic foot.

[0095] As described below, the axis of rotation of the foot spring assembly is located in front of the tapered axis of the tapered connector 132. Therefore, when standing, the amputee's center of gravity (COM) is directly above the axis of rotation, allowing the amputee to stand without significant movement of the ankle assembly 118. This design feature also minimizes impact when the ankle reaches the end of the hydraulic range in the dorsiflexion direction (dorsiflexion limiter).

[0096] Ankle assembly 118 may include both a dorsiflexion limiter and / or a plantarflexion limiter. A dorsiflexion limiter is a component or component assembly that establishes the maximum dorsiflexion angle of ankle assembly 118 and prosthetic foot 104. A plantarflexion limiter is a component or component assembly that establishes the maximum plantarflexion angle of ankle assembly 118 and prosthetic foot 104. An exemplary dorsiflexion limiter may include, for example, a dorsiflexion limiter damper that reduces or eliminates impact at the end of the dorsiflexion stroke. When ankle assembly 118 dorsiflexes, it eventually reaches the end of its hydraulic range of motion. At this point, the flexion of spring assembly 116 begins to engage and bend. If this transition is abrupt, it can be uncomfortable for the amputee. As ankle assembly 118 reaches this transition point, the dorsiflexion limiter damper gradually compresses, allowing a smooth transition from hydraulic function to the flexion function of spring assembly 116. Furthermore, the dorsiflexion limiter buffer can be a thin disc spring that will respond in a similar manner to the elastomeric limiter, providing a smooth transition between the hydraulic and compound spring functions of the ankle assembly 118 and the spring assembly 116. In any embodiment, the dorsiflexion limiter may alternatively exclude any buffer at all. The dorsiflexion limiter can engage at, for example, an ankle position or a standing position at 0°, 2°, or 4°. This facilitates upright standing for amputees.

[0097] The plantar flexion limiter can be established, for example, simply by the displacement distance of the piston in the piston chamber of a hydraulic cylinder. When the hydraulic piston reaches the maximum stroke position in the cylinder, the piston and shaft cannot travel further. Once the piston reaches the maximum stroke position (whether in dorsiflexion or plantarflexion corresponding to the maximum or minimum cylinder extension), it is still free to leave that maximum position and return to another position within the piston stroke range.

[0098] The base 186 has a first side / bottom side 192 and a second side / top side 194. The first side 192 is sized and shaped to correspond to the shape of the first spring member 150, such that the rear end of the first side 192 is substantially flush with the first spring member 150. The second side 194 is sized and shaped to accommodate three sets of drilled holes that attach the base 186 to the first spring member 150, the hydraulic cylinder of the telescopic link 188, and the prosthetic adapter 190. Specifically, the base 186 defines a first set of drilled holes 196a, 196b, a second set of drilled holes 198a, 198b, and a third set of drilled holes 200a, 200b. The first set of drilled holes 196a, 196b is configured to receive fasteners 130a, 130b that secure the base 186 to the first spring member 150. The second set of drill holes 198a and 198b are configured to receive a portion of the telescopic link 188 to hold the telescopic link 188 in position while allowing the telescopic link 188 to rotate relative to the base 186. Similarly, the third set of drill holes 200a and 200b are configured to receive a portion of the prosthesis adapter 190 to hold the prosthesis adapter 190 in position while allowing the prosthesis adapter 190 to rotate relative to the base 186. The base 186 is a monolithic and rigid component that does not function as a spring and does not exhibit significant deflection or deformation during use, and is made of a lightweight metal such as aluminum, magnesium, or titanium.

[0099] The prosthetic adapter 190 defines: a hole 202 configured to receive a tapered connector 132, a cavity 204 configured to receive a portion of a telescopic link 188, a fourth set of drilled holes 206 configured to receive a piston fastener 208, and a base hole 210 configured to receive a base fastener 212. The prosthetic adapter 190 is sized and shaped to accommodate the tapered connector 132, the cavity 204, the fourth set of drilled holes 206, the piston fastener 208, the base hole 210, and the base fastener 212. Specifically, the prosthetic adapter 190 includes a first portion or spherical portion 214 and a second portion or tapered portion 216. The spherical portion 214 defines the cavity 204 and is spherical so that the cavity 204 has a sufficiently large volume to receive a portion of the telescopic link 188. Furthermore, the spherical portion 214 is large enough to define the outlet hole 202 and the fourth set of drilled holes 206 to accommodate the tapered connector 132 and the piston fastener 208. The tapered portion 216 is smaller than the spherical portion 214, such that the tapered portion 216 is received between the third set of drilled holes 200a, 200b of the base 186. The base fastener 212 extends between the third set of drilled holes 200a, 200b and through the base hole 210 to attach the prosthesis adapter 190 to the base 186.

[0100] Figures 6, 7, and 8 illustrate exemplary reference features applied to the prosthetic foot 104 described above. The prosthetic foot includes a three-dimensional edge 501 paired with a marker 502, serving as a first and second reference feature, respectively. Features 501 and 502 have a spatial relationship with each other, which varies substantially based on the rotational position of the joint, specifically based on the rotational position of the prosthetic adapter 190 relative to the telescopic link 188. The spatial relationship of features 501 and 502 specifically indicates when the links of the prosthetic joint are positioned in a neutral rotational position (and correspondingly, the joint as a whole is in its neutral rotational position), and similarly indicates when they are not in the neutral rotational position.

[0101] The combination of features 501 and 502 collectively conveys whether the prosthetic joint is in a neutral position. When features 501 and 502 appear aligned, the prosthetic joint is in a neutral position. In other words, the alignment of features 501 and 502 alone, through visual inspection, conveys that the prosthetic joint is in a neutral position. Whenever features 501 and 502 appear misaligned, that is, when they appear to be spaced apart from each other, the prosthetic joint is not in a neutral position. In other words, the misalignment of features 501 and 502 alone, through visual inspection, conveys that the prosthetic joint is not in a neutral position.

[0102] As used in this disclosure, the alignment of two reference features similar to features 501 and 502, particularly the alignment perceived through routine visual inspection by a prosthetist, inherently allows for a certain acceptable tolerance of deviation relative to what might be called “perfect” or “absolute” alignment. As a non-limiting exemplary example, the first reference feature 501 and the second reference feature 502 are sized, shaped, and arranged outside the respective individual moving parts of the joint such that a rotation deviating from the neutral rotational position by one degree or more corresponds to a distance of at least 0.5 mm or 1 mm between the first reference feature 501 and the second reference feature 502. This threshold is important because it takes into account the natural capabilities of the human eye. At a distance of several feet, for example, if the distance is at least 0.5 mm or at least 1.0 mm, the human eye can perceive with considerable reliability that two objects are actually separated by a perceptible distance. When the separation distance is smaller, it becomes more difficult for an ordinary observer several feet away to easily discern the distance between the two objects. Therefore, a threshold of 0.5 mm or 1 mm can serve as a reliable basis for prosthetists to reliably identify whether the two features 501 and 502 appear to be aligned or misaligned when the joint is raised to an arm's length from their face. When the two features may still appear to be aligned (e.g., the separation distance is less than 0.5 mm), the maximum permissible rotation of one degree constitutes an exemplary error tolerance relative to what may be called a “true” or “absolute” neutral position. Alternative embodiments may adjust the 0.5 mm threshold or the acceptable error tolerance of 1 degree based on other considerations, such as how close the prosthetist is willing to raise the device to their eyes, and the specific size, shape, and arrangement of the reference features in a given embodiment.

[0103] As shown in features 501 and 502 of Figures 6-8, one or two exemplary reference features can be any (or a combination of) the following: two-dimensional mark, three-dimensional mark, engraving, line, curve, edge, boundary line, or border. These examples are non-limiting and overlap in various aspects, as conveyed by their general meaning. For example, the physical three-dimensional edge of a shaped solid (e.g., the metal or plastic of a prosthesis) can also be accurately described by the more general term "three-dimensional mark." Of course, not all visually visible lines, curves, edges, etc., of a prosthetic joint are marks. The term "mark" as used in this disclosure describes only those features that have a specific and deliberately designed significance relative to at least one other feature. This specific and deliberately designed significance lies in the fact that the spatial relationship between the at least two features varies based on rotational position, and that the spatial relationship visually conveys in a reliable and reproducible manner whether the prosthetic joint is in a rotational position of particular significance, such as a neutral position.

[0104] The sole purpose of the existence (or configuration to have a specific visual appearance) of at least one of the reference features in each pair is to visually convey whether the prosthetic joint is in a neutral position. Similarly, the second reference feature in the pair may also exist solely for this purpose, without any other purpose. Alternatively, the second reference feature may have some other purpose or function; for example, it may be a three-dimensional feature, such as an edge of one of the links and part of the housing of that link.

[0105] exist Figure 6A In this configuration, the ankle assembly is disassembled, therefore the adapter portion 190 is displaced to more clearly show the retractable link 188. Features 504, 502, and 503 are visible. Feature 504 indicates the angular orientation of the retractable link at its maximum length. Feature 502 represents the neutral position. Feature 503 indicates the angular orientation of the retractable link at its minimum length. If an embodiment has a neutral position, this position can be indicated by a single marker. However, in some embodiments, it may be necessary to provide markers indicating the maximum and minimum limits of the angular orientation to allow the user to perceive the sensitivity of the angular orientation and to indicate the location of the neutral position within the possible angular orientation range.

[0106] Figure 6B The ankle assembly is shown in a perspective view, clearly showing the physical edge of the adapter portion 190, which serves as feature 501 in this exemplary embodiment. An alignment feature appears on the left side of the ankle assembly. Embodiments may include alignment features located at any of a variety of locations on the joint assembly, including, but not limited to, the right side (see, for example, see...). Figure 6A ), left side (see, for example) Figure 6B (or multiple sides, such as both the right and left sides). In Figure 6B In this configuration, the component is in its maximum dorsiflexion position. Therefore, feature 504 is aligned with feature 501. Features 502 and 503 are visible and clearly not aligned with feature 501, each separated from feature 501 by a clearly visible distance.

[0107] exist Figure 7A In the image, features 501 and 502 are clearly separated, therefore the prosthetist can determine that the prosthesis is not in a neutral position. In fact, Figure 7A The prosthesis is shown in its maximal dorsiflexion position. Feature 501 is aligned with feature 504. Figure 7B In this context, feature 501 and feature 502 are spatially aligned. Feature 501 is located directly at or on top of feature 502. Based solely on visual observation, the alignment of features 501 and 502 conveys... Figure 7B The prosthesis described herein is in a neutral position. Figure 7CIn the middle, since feature 501 has moved past feature 502, and the body of the prosthetic adapter 190 obscures feature 501, making it invisible, feature 502 is no longer visible at all.

[0108] Exemplary embodiments may include reference features for indicating locations other than a neutral location. For example, in Figure 7A In this design, the prosthesis includes a reference feature 503 serving as the maximum plantar flexion line. When feature 501 and feature 503 are aligned, the prosthesis is in the maximum plantar flexion position. The alignment of features 501 and 503 visually conveys that the prosthesis is in the maximum plantar flexion position.

[0109] In joints with three or more links, reference features can be provided to characterize the relative positions of any pair of connected links within the assembly. Taking ankle assembly 118 as an example, each of the three links in the force triangle is directly connected to two other links. Reference features conveying a specific position (e.g., neutral position) of the assembly can be provided only on links 188 and 190 (e.g., as shown), or only on links 188 and 186, or only on links 186 and 190. Alternatively, reference features can be provided on any two of such link pairs. As yet another alternative, reference features can be provided on all three link pairs. The meaning indicated by the alignment of reference features in one link pair can be the same as or different from the meaning indicated by the alignment of reference features in another independent link pair. For example, the first set of reference features (for the first link pair) may indicate a neutral position when aligned, while the second set of reference features (for the second link pair) may indicate a maximum flexion position when aligned. Alternatively, the second set of reference features can indicate a neutral position during alignment, thus intentionally functioning as a redundant setting of the first set of reference features. This redundancy can still have its own practical use, for example, by providing an alternative position on the prosthesis for prosthetists to check and verify the angular position of the prosthesis.

[0110] Figure 8AAn ankle assembly comprising a base 186, a telescopic link 188, and a prosthesis adapter portion 190 is shown, along with a temporarily attached alignment link 504. The alignment link 504 is temporarily connected to the ankle assembly. Connectors such as pins 505 and 506 are used to temporarily connect the alignment link 504 to the prosthesis adapter portion 190 and the base 186, respectively. The alignment link 504 is configured to constrain the ankle assembly such that the base 186, the telescopic link 188, and the prosthesis adapter portion 190 are forced to be at a fixed angle relative to each other. The ankle assembly is forced to present and remain in a single position within its normal range of pivoting motion. As long as the alignment link 504 remains attached via pins 505 and 506, the angular positions of the base 186, the telescopic link 188, and the prosthesis adapter portion 190 are fixed relative to each other. The length of the alignment link 504 is selected such that when the alignment link 504 is connected to the ankle assembly, the ankle assembly is secured in a specific target position (e.g., a neutral position). Once the desired alignment of the prosthesis is achieved, the alignment link 504 is removed, allowing the base 186, the telescopic link 188, and the prosthesis adapter portion 190 to move relative to each other again within their intended range of motion. The alignment link 504 is used exclusively for the alignment procedure. The alignment link 504 is not used during the amputee's use of the prosthesis.

[0111] Figure 8B The image shows an ankle assembly consisting of a base 186, a telescopic link 188, and a prosthesis adapter portion 190, as well as an alignment link 509. The function of the alignment link 509 is related to... Figure 8A The alignment link 504 is similar. However, the alignment link 509 is not connected to the ankle assembly via a connector such as a pin. Instead, using this alignment link requires reducing the angle between the base 186 and the adapter portion 190 until a firm abutment is formed between the end 507 of the alignment link 509 and the adapter portion 190, and a firm abutment is formed between the end 508 of the alignment link 509 and the base 186. With the ends 507 and 508 of the alignment link thus positioned within the ankle assembly, the angle formed between the prosthesis portion 190 and the base 186 cannot be further reduced. This minimum angle corresponds to a target position, such as a neutral position.

[0112] An exemplary method for aligning a prosthesis or orthosis comprising a joint assembly having a range of pivoting motion may include the steps of: temporarily attaching or positioning an alignment link of fixed length within the joint assembly such that the joint assembly is fixed at a single target location within the range of motion; performing one or more alignment procedures on the prosthesis or orthosis while the alignment link is within the joint assembly; and removing the alignment link to allow the joint assembly to move throughout its entire range of pivoting motion. Initially, compression of the rotating component may be necessary to set and maintain the target position. Alternatively, once the target position is set, at least no stretching force should be present.

[0113] The joint can be positioned at any target location by means of reference features or by an attached alignment link. For illustrative purposes, marker 502 provides a visual indication of the neutral position relative to the range of travel, and alignment link 504 similarly secures the ankle assembly in the neutral position as long as it remains attached to adapter 190 and base 186. However, in some embodiments, a marker similar to marker 502 may indicate a target location not associated with the neutral position. In some embodiments, alignment link 504 may be set or can be set to a length that, once attached to the joint assembly, secures the joint in a target location unrelated to the neutral position. In some embodiments, multiple reference features may be present, indicating multiple target locations, all of which are within the joint's range of travel.

[0114] Figure 9 A non-limiting example of an exemplary prosthetic leg 900 is shown, which includes a receiving cavity 901 (e.g., configured to receive and fit the amputated limb of an amputee), a prosthetic adapter 902, a strut 903, and a prosthetic foot system 100. Exemplary embodiments of this disclosure enable the reliable and reproducible setting of a prosthesis at a specific angle (e.g., but not limited to a neutral position), which is particularly helpful to personnel such as prosthetic technicians responsible for performing prosthetic alignment to adapt the product to a particular user. For example, it is desirable to be able to efficiently and accurately place the prosthesis in a neutral position during the workbench alignment and / or dynamic alignment discussed in the background section above. In practice, exemplary methods may include the steps of aligning a first reference feature and a second reference feature with each other, as discussed in the above embodiments, or as shown in FIG8 or... Figure 9 When the alignment link shown in any of these embodiments is in place, one or more alignment procedures (e.g., stage alignment and / or dynamic alignment steps) are performed on the prosthesis. Those skilled in the art will understand that the alignment procedures performed on the prosthesis joint mentioned in this disclosure can be considered as implicitly requiring the alignment of any one or more components of the entire prosthesis to which the prosthesis joint belongs. For example, Figure 9 The prosthetic leg 900 is a non-limiting example of the entire prosthesis. Alignment procedures involving the alignment of the foot system 100 or its ankle joint may only require adjustments to the ankle assembly within the foot system, or adjustments to the ankle assembly and foot spring assembly, or adjustments to one or more of the ankle assembly, foot spring assembly, prosthesis adapter 902, and / or other components. It should be understood that different prostheses may involve adjustments to components other than those listed above, for example during stage alignment and / or dynamic alignment, depending on the natural joint or multiple joints and associated body parts that the prosthesis is intended to replace.

[0115] Figure 10 The prosthetic foot system 100 is shown positioned in a neutral standing posture on a flat, level surface 372, such that the taper angle 374 between the top surfaces of the tapered connector 132 is 0°. Figure 10 As shown, the tapered connector 132 defines a tapered connector axis 376 passing through the middle of the tapered connector 132, and this axis is vertically oriented. The piston assembly 220 defines a piston axis 378 passing through the middle of the shaft 222.

[0116] Figure 11 The prosthetic foot system 100 is shown positioned on a flat surface 372 in maximum plantar flexion, such that the taper angle 374 of the tapered connector 132 is 0°. Figure 11 In the illustrated embodiment, the first pivot distance 386 is about 50 mm to about 60 mm or about 58.8 mm, the second pivot distance 388 is about 25 mm to about 40 mm or about 33.0 mm, the third pivot distance 390 is about 50 mm to about 60 mm or about 52.5 mm, the lever arm 392 is about 25 mm to about 40 mm or about 32.8 mm, the tapered axis distance 394 is about 19 mm to about 26 mm or about 23.0 mm, the axis angle 396 is about 15° to about 20° or about 18.3°, the top spring angle is about 20° to about 30° or about 29.1°, and the heel distance 400 is about 30 mm to about 40 mm or about 30.23 mm.

[0117] Figure 12 The illustration shows the prosthetic foot system 100 positioned on a flat surface 372, with the system arranged within a shoe (not shown) such that the taper angle 374 of the tapered connector 132 is 2°. The heel distance 400 is a typical heel height, approximately 5 mm to approximately 20 mm or approximately 10 mm. Heel height is the difference in thickness between the sole and the metatarsal region and the heel region. Figure 12 In the illustrated embodiment, the first pivot distance 386 is about 50 mm to about 60 mm or about 58.8 mm, the second pivot distance 388 is about 25 mm to about 40 mm or about 33.0 mm, the third pivot distance 390 is about 50 mm to about 60 mm or about 57.5 mm, the lever arm 392 is about 25 mm to about 40 mm or about 32.0 mm, the tapered axis distance 394 is about 19 mm to about 26 mm or about 23.0 mm, the axis angle 396 is about 15° to about 20° or about 17.4°, and the top spring angle is about 20° to about 30° or about 22.3°.

[0118] Figure 13 The diagram shows the prosthetic foot system 100 positioned on a flat surface 372 in a position of maximum dorsiflexion, such that the taper angle 374 of the tapered connector 132 is 0°. Figure 13 In the illustrated embodiment, the first pivot distance 386 is approximately 50 mm to approximately 60 mm or approximately 58.8 mm, the second pivot distance 388 is approximately 25 mm to approximately 40 mm or approximately 33.0 mm, the third pivot distance 390 is approximately 50 mm to approximately 60 mm or approximately 58.6 mm, the lever arm 392 is approximately 25 mm to approximately 40 mm or approximately 31.7 mm, the tapered axis distance 394 is approximately 19 mm to approximately 26 mm or approximately 23.0 mm, the axis angle 396 is approximately 15° to approximately 20° or approximately 17.1°, and the top spring angle is approximately 10° to approximately 20° or approximately 18.2°. Both the heel and forefoot areas are located on the ground.

[0119] The foregoing description, for illustrative purposes, has been described with reference to specific embodiments. However, the illustrative discussion above is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the above teachings. Embodiments have been chosen and described in order to best explain the principles of the systems and methods of the invention and their practical application, thereby enabling others skilled in the art to best utilize the systems and methods of the invention, as well as various embodiments with various modifications suitable for particular intended uses.

[0120] Where numerical ranges are provided in this disclosure, it should be understood that, unless the context explicitly indicates otherwise, every intermediate value between the upper and lower limits of the range (to one-tenth of the lower limit unit), as well as any other stated value or intermediate value within the range, is included within the invention. The upper and lower limits of these smaller ranges may be independently included within the smaller ranges and also within the invention, but are subject to any specific exclusions within the ranges. Where the range includes one or two limit values, the invention also includes ranges that exclude any one or both of those included limit values.

[0121] Unless otherwise stated, the terms “a” or “an” as used in the specification and claims shall be interpreted as meaning “at least one”. Furthermore, this expression is intended as a prior basis for the use of exclusive terms such as “only” or “just”, or for the use of “negative” limiting terms, in relation to the recitation of elements of the claims. Additionally, for ease of use, the words “comprising” and “having” as used in the specification and claims are interchangeable with and have the same meaning as the word “including”. Furthermore, the term “based on” in the specification and claims shall be interpreted as meaning “at least based on”.

[0122] Upon reading this disclosure, those skilled in the art will understand that each individual embodiment described and illustrated herein has discrete components and features, which may be separated from or combined with features of any other several embodiments without departing from the scope or spirit of the invention. Any of the methods described may be performed in the listed order of events or in any other logically feasible order.

[0123] While exemplary embodiments of the invention have been disclosed herein, those skilled in the art will recognize that various changes and modifications may be made without departing from the scope of the invention as defined by the appended claims.

Claims

1. A prosthetic joint for external use, comprising: Joint assembly, comprising: The first link includes a first reference feature. A second link, rotatably attached to the first link to define a first pivot point, wherein the second link includes a second reference feature, and A third link is rotatably attached to the first link to define a second pivot point, and is rotatably attached to the second link to define a third pivot point; The prosthetic joint is capable of rotating through an angular range from maximum flexion to maximum extension. The first reference feature and the second reference feature have a spatial relationship that varies based on the rotation angle of the prosthetic joint, and The alignment of the first reference feature and the second reference feature indicates that the joint assembly is in a neutral position, and the misalignment of the first reference feature and the second reference feature indicates that the joint assembly is not in a neutral position.

2. The prosthetic joint according to claim 1, wherein, The first reference feature and the second reference feature are each a marker, a three-dimensional edge, or a contour.

3. The prosthetic joint according to claim 2, wherein, The prosthetic joint is a prosthetic ankle.

4. The prosthetic joint according to claim 1, wherein, At at least some angles within the stated angle range, both the first reference feature and the second reference feature are simultaneously visible on the exterior of the prosthetic joint.

5. The prosthetic joint according to claim 1, wherein, The first reference feature and the second reference feature are configured such that: When the prosthetic joint (i) rotates away from the neutral position and (ii) rotates toward the maximum flexion position and / or maximum extension position, the physical distance between the first reference feature and the second reference feature visibly increases in size, and / or When the prosthetic joint (i) rotates toward the neutral position and (ii) away from the maximum flexion position and / or maximum extension position, the physical distance between the first reference feature and the second reference feature visibly decreases in size.

6. The prosthetic joint according to claim 1, wherein, The first reference feature and the second reference feature are respectively sized, shaped and arranged outside the first link and the second link, such that a rotation of one degree or more away from the neutral rotation position corresponds to a distance of at least 0.5 mm between the first reference feature and the second reference feature.

7. The prosthetic joint according to claim 1, wherein, The prosthetic joint is a prosthetic ankle.

8. A prosthetic joint for external use, comprising: A joint assembly includes a first link rotatably connected to a second link, such that the angle between the first link and the second link can vary between a minimum angle and a maximum angle. The joint assembly is configured to have a neutral position corresponding to a single angular measurement between the minimum and maximum angles. Wherein, the first link includes a first reference feature, and the second link includes a second reference feature. The first reference feature and the second reference feature have a spatial relationship that varies based on the angle between the first link and the second link. The alignment of the first reference feature and the second reference feature indicates that the joint is in a neutral position, and the misalignment of the first reference feature and the second reference feature indicates that the joint is not in a neutral position.

9. The prosthetic joint according to claim 8, wherein, The minimum angle corresponds to the flexion limit of the joint assembly, and the maximum angle corresponds to the extension limit of the joint assembly.

10. The prosthetic joint of claim 8, further comprising a third link rotatably connected to the first link and the second link to define a force triangle between the first link, the second link, and the third link, wherein, At least one of the first link, the second link, and the third link can extend or retract to any of a plurality of different lengths.

11. The prosthetic joint according to claim 10, wherein, The joint in question is the ankle joint.

12. The prosthetic joint according to claim 8, wherein, The first reference feature and the second reference feature are each a marker, a three-dimensional edge, or a contour.

13. The prosthetic joint according to claim 8, wherein, At at least some angles between the minimum angle and the maximum angle, both the first reference feature and the second reference feature are simultaneously visible on the exterior of the prosthetic joint.

14. The prosthetic joint according to claim 8, wherein, The first reference feature and the second reference feature are configured such that: When the joint (i) moves away from the neutral position and (ii) changes position toward the maximum and / or minimum angle, the physical distance between the first reference feature and the second reference feature visibly increases in size, and / or When the joint (i) moves toward the neutral position and (ii) moves away from the maximum and / or minimum angle, the physical distance between the first reference feature and the second reference feature visibly decreases in size.

15. The prosthetic joint according to claim 8, wherein, The first reference feature and the second reference feature are respectively sized, shaped and arranged outside the first component and the second component, such that a rotation of one degree or more away from the neutral rotational position corresponds to a distance of at least 0.5 mm between the first reference feature and the second reference feature.

16. The prosthetic joint according to claim 8, wherein, The joint in question is the ankle joint.

17. A method for aligning an externally used prosthesis, the prosthesis including a joint assembly having a pivoting range of motion, the joint assembly including a first link rotatably connected to a second link such that the angle between the first link and the second link is variable between a minimum angle and a maximum angle, wherein... The joint assembly is configured to have a neutral position corresponding to a single angular measurement between the minimum angle and the maximum angle, the method comprising: The joint assembly is placed in the neutral position by aligning a first reference feature on the first link with a second reference feature on the second link, wherein the first and second reference features have a spatial relationship that varies based on the angle between the first and second links, wherein alignment of the first and second reference features indicates that the joint assembly is in the neutral position, and misalignment of the first and second reference features indicates that the joint assembly is not in the neutral position; and One or more alignment procedures are performed on the prosthesis while the first reference feature and the second reference feature are aligned.

18. The method according to claim 17, wherein, The one or more alignment procedures are used to align the prosthetic ankle.

Images