Systems, apparatus, and methods for multi-axis assemblies
The polyaxial prosthetic assembly with a resilient undulating member and offset protrusions addresses the need for both rotational and vertical movement in prosthetic devices, enhancing gait efficiency and safety for lower limb amputees.
Patent Information
- Application Number
- JP2023543169
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-06-17
- Filing Date
- 2022-01-11
- Publication Date
- 2025-09-26
- Estimated Expiration
- 2042-01-11
AI Technical Summary
Existing prosthetic devices for lower limb amputees lack effective mechanisms for providing both rotational and vertical movement, which are crucial for improved gait efficiency and safety, especially in varying environmental conditions.
A polyaxial prosthetic assembly utilizing a resilient closed undulating member with offset protrusions and recesses in the prosthetic members, allowing for vertical and rotational movement, and a shaft that is movably disposed within a longitudinal lumen, with a shaft retainer to prevent separation, and a mounting interface for attaching to a foot prosthesis.
The assembly provides enhanced vertical shock absorption and rotational movement, improving gait efficiency and safety for users with varying mobility needs, including those traversing uneven surfaces and different speeds.
Smart Images

Figure 0007744995000002 
Figure 0007744995000003 
Figure 0007744995000004
Abstract
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 139,248, entitled "System, Apparatus, and Method for Multi-Axis Assembly," filed January 19, 2021, and is a continuation-in-part of U.S. Application No. 17 / 350,621, entitled "Mounting Bracket for Connecting Prosthetic Limbs and Legs," filed June 17, 2021, and incorporates by reference the disclosures of all such applications. [Technical Field]
[0002] The present disclosure relates generally to prosthetic devices for lower limb amputees, and more particularly to methods and apparatus for multi-axial assemblies for providing rotational and vertical movement to lower limb prosthetic devices. Summary of the Invention
[0003] A polyaxial prosthetic assembly including a resilient closed undulating member is used to provide vertical and rotational movement to a lower limb prosthesis. A shaft is disposed through a resilient bumper, a first prosthetic member is fixedly attached to the shaft and engages a first surface of the undulating member, and a second prosthetic member includes an inner cavity for movably receiving the shaft. The prosthetic member is engaged to the resilient bumper using protrusions located in recesses in the resilient bumper, and the prosthetic member and bumper are configured such that the protrusions from each member are offset from the protrusions of the other member, resulting in a undulating appearance on the outer surface of the resilient bumper.
[0004] In one embodiment, a prosthetic assembly is provided, comprising: an elastic undulating body having an outer periphery, a first surface, a second surface opposite the first surface, and an internal opening therebetween; a longitudinal shaft disposed in the internal opening of the undulating member; a first prosthetic body coupled to the longitudinal shaft and contacting the first surface of the undulating member; and a second prosthetic body including a longitudinal lumen and contacting the second surface of the undulating member, the longitudinal shaft being movably disposed in the longitudinal lumen. The undulating body may include a first plurality of recesses on the first surface of the undulating body. The first prosthetic body may include a first plurality of protrusions configured to form a mechanical fit with the first plurality of recesses of the undulating body. The undulating body may include a second plurality of protrusions on the second surface of the undulating body. The second prosthetic body may include a second plurality of protrusions configured to form a mechanical fit with the second plurality of recesses of the undulating body. The first plurality of recesses may be rotationally offset from the second plurality of recesses when no net rotational force is acting on the corrugated body. The first plurality of recesses may include equal angular spacing relative to the central axis of the corrugated body, and the second plurality of recesses may include equal angular spacing relative to the central axis of the corrugated body. The corrugated body may further include an internal seal radially offset from the outer periphery of the corrugated member and extending from a second surface of the corrugated body surrounding the internal opening of the corrugated body. The angular spacing of the first plurality of recesses and the angular spacing of the second plurality of recesses may be 90 degrees. The first plurality of recesses and the second plurality of recesses may be offset by 40 to 65 degrees. The first plurality of recesses and / or the second plurality of recesses may each include four recesses. Each recess of the first plurality of recesses and the second plurality of recesses may include an outer peripheral opening region, a radially inward wall opposite the outer peripheral opening, and opposing first and second sidewalls adjacent the radially inward wall. The radially inward wall and the opposing first and second walls may comprise a U-shape on a cross section through the undulating member.Each recess of the first plurality of recesses may further include a first surface opening region on the first surface of the undulating body, the first surface opening region being continuous with the circumferential opening region of the same recess, and an intermediate wall opposite the first surface opening region, adjacent to the first and second walls of the same recess. Each recess of the second plurality of recesses may further include a second surface opening region on the second surface of the undulating body, the second surface opening region being continuous with the circumferential opening region of the same recess, and an intermediate wall opposite the second surface opening region, adjacent to the first and second walls of the same recess. Each recess of the first plurality of recesses and the second plurality of recesses includes a non-planar surface opening. The first prosthetic body may be integrally formed with the longitudinal shaft. The second prosthetic body may be configured to allow axial and rotational movement of the longitudinal shaft within the longitudinal lumen of the second prosthetic body. The prosthetic assembly may further include a shaft retainer removably attached to the shaft and configured to resist separation between the longitudinal shaft and the second prosthetic body. The shaft retainer may include a removable fastener configured to removably attach to the longitudinal shaft, an annular seal configured to slidably seal the shaft retainer to the second prosthetic body, and a retaining washer having a circumferential recess in which the annular seal partially resides. The shaft retainer may further include a spring. The spring may be configured to maintain compression of the elastic body when the prosthetic assembly is in an unloaded state. The prosthetic assembly may further include a mounting pyramid. The mounting pyramid may be integrally formed with the longitudinal shaft. The second prosthetic body may further include a mounting interface configured to mount to a foot prosthesis. The mounting interface may include multiple lumens, each configured to removably receive a fastener. The multiple lumens may be multiple transverse lumens. The second prosthetic body may further include an annular cavity for at least partially receiving the undulating body. A diameter of the internal opening of the undulating body may be greater than a diameter of the longitudinal shaft located in the internal opening of the undulating body.The longitudinal shaft may include a transverse stop surface located between the first and second ends of the longitudinal shaft and configured to displaceably abut a corresponding stop surface of the second prosthetic body. The prosthetic assembly may further include a compression collar disposed between the first and second prosthetic bodies and configured to limit displacement of the longitudinal shaft relative to the longitudinal lumen of the second prosthetic body. [Brief explanation of the drawings]
[0005] These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings.
[0006] [Figure 1A] FIG. 10 is a rear view of a shock rotator assembly in accordance with an exemplary embodiment of the present technology; [Figure 1B] FIG. 10 is a side view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 1C] FIG. 10 is a front view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 1D] FIG. 10 is a top view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 1E] FIG. 10 is a bottom view of an assembly in accordance with an exemplary embodiment of the present technology. [Figure 1F] FIG. 10 is a front perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 1G] FIG. 10 is a rear perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 1H] FIG. 1C is a cross-sectional side view of the assembly of FIG. 1B in accordance with an exemplary embodiment of the present technology. [Figure 2A] 1A-1G in accordance with an exemplary embodiment of the present technology. FIG. [Figure 2B] FIG. 1C is a side view of the elastic body of the assembly of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 2C]FIG. 1C is a bottom view of the elastic body of the assembly of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 2D] FIG. 14 is a top perspective view of an elastic body in accordance with an exemplary embodiment of the present technology; [Figure 2E] 12 is a cross-sectional view of an elastic body in accordance with an exemplary embodiment of the present technology; [Figure 3A] FIG. 1C is a front perspective view of the exemplary assembly of FIGS. 1A-1G attached to an exemplary foot prosthesis in accordance with an exemplary embodiment of the present technology. [Figure 3B] FIG. 1C is a side view of the exemplary assembly of FIGS. 1A-1G attached to an exemplary foot prosthesis in accordance with an exemplary embodiment of the present technology. [Figure 3C] FIG. 3B is a top view of a combined assembly and prosthesis of FIG. 3A in accordance with an exemplary embodiment of the present technology. [Figure 3D] FIG. 3B is a rear view of the combined assembly and prosthesis of FIG. 3A in accordance with an exemplary embodiment of the present technology. [Figure 3E] FIG. 3B is a front view of the combined assembly and prosthesis of FIG. 3A in accordance with an exemplary embodiment of the present technology. [Figure 4A] FIG. 1C is a rear view of the exemplary assembly of FIGS. 1A-1G, excluding an elastic body, in accordance with an exemplary embodiment of the present technology. [Figure 4B] FIG. 1C is a side view of the exemplary assembly of FIGS. 1A-1G, excluding an elastic body, in accordance with an exemplary embodiment of the present technology. [Figure 4C] FIG. 1C is a front view of the exemplary assembly of FIGS. 1A-1G without an elastic body in accordance with an exemplary embodiment of the present technology. [Figure 4D] 1 is a cross-sectional view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 4E] FIG. 10 is a rear perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 4F] FIG. 10 is a front perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 5A] 1A-1G in accordance with an exemplary embodiment of the present technology. FIG. [Figure 5B] FIG. 1C is a side view of the first housing of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 5C] 1A-1G are bottom views of the first housing of each of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 5D] FIG. 5C is a cross-sectional view of the first housing of FIG. 5B in accordance with an exemplary embodiment of the present technology. [Figure 5E] FIG. 10 is a top perspective view of a first housing in accordance with an exemplary embodiment of the present technology. [Figure 5F] FIG. 10 is a bottom perspective view of a first housing in accordance with an exemplary embodiment of the present technology. [Figure 6A] FIG. 1C is a side view of the shaft of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 6B] 12 is a cross-sectional view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 6C] FIG. 14 is a top perspective view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 6D] FIG. 10 is a top view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 6E] FIG. 10 is a bottom view of a shaft in accordance with an exemplary embodiment of the present technology. [Figure 7A] FIG. 1C is a rear view of the second housing of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 7B] FIG. 1C is a side view of the second housing of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 7C] FIG. 1C is a front view of the second housing of FIGS. 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 7D] FIG. 7C is a cross-sectional view of the second housing of FIG. 7B in accordance with an exemplary embodiment of the present technology. [Figure 7E] FIG. 10 is a top perspective view of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 7F] FIG. 10 is a bottom perspective view of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 7G]FIG. 10 is a top view of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 7H] FIG. 10 is a bottom perspective view of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 8A] 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 8B] 1A-1G in accordance with an exemplary embodiment of the present technology. [Figure 8C] FIG. 7C is a cross-sectional view of the retention washer of FIG. 7B in accordance with an exemplary embodiment of the present technology. [Figure 8D] FIG. 13 is a bottom view of a retention washer in accordance with an exemplary embodiment of the present technology; [Figure 8E] FIG. 14 is a bottom perspective view of a retention washer in accordance with an exemplary embodiment of the present technology; [Figure 8F] FIG. 14 is a top perspective view of a retention washer in accordance with an exemplary embodiment of the present technology; [Figure 9] FIG. 10 is a cross-sectional view of another embodiment of an assembly including an integrated first housing and shaft in accordance with an exemplary embodiment of the present technology; [Figure 10] FIG. 10 is a cross-sectional view of another embodiment of an assembly including a separate first housing and shaft in accordance with an exemplary embodiment of the present technology; [Figure 11A] FIG. 10 is a front view of another embodiment of an exemplary shock rotator assembly in accordance with an exemplary embodiment of the present technique; [Figure 11B] FIG. 11B is a cross-sectional side view of the assembly of FIG. 11A in accordance with an exemplary embodiment of the present technology. [Figure 12A] FIG. 11C is a rear view of another embodiment of the assembly shown in FIGS. 11A-11B, excluding the elastic, in accordance with an exemplary embodiment of the present technology. [Figure 12B] 1 is a cross-sectional view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 12C] FIG. 10 is a rear perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 12D] FIG. 10 is a front perspective view of an assembly in accordance with an exemplary embodiment of the present technology; [Figure 13A] FIG. 10 is a side view of another embodiment of a shaft in accordance with an exemplary embodiment of the present technology. [Figure 13B] 12 is a cross-sectional view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 13C] FIG. 14 is a top perspective view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 13D] FIG. 10 is a top view of a shaft in accordance with an exemplary embodiment of the present technology; [Figure 13E] FIG. 10 is a bottom view of a shaft in accordance with an exemplary embodiment of the present technology. [Figure 14A] FIG. 13 is a rear perspective view of another embodiment of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 14B] FIG. 10 is a top view of a second housing in accordance with an exemplary embodiment of the present technology. [Figure 15] 14A-14B showing an annular flange according to an exemplary embodiment of the present technology. [Figure 16] 13A-13E is a perspective view of a first housing shown in FIGS. 5A-5D and a shaft shown in FIGS. 13A-13E in accordance with an exemplary embodiment of the present technology. FIG. [Figure 17] FIG. 10 is a side perspective view of a second housing with a portion of the shaft disposed within the lumen and the shaft in a neutral position in accordance with an exemplary embodiment of the present technology. [Figure 18] FIG. 10 is a side perspective view of a second housing with a portion of the shaft disposed within the lumen and the shaft rotated clockwise from a neutral position in accordance with an exemplary embodiment of the present technology. [Figure 19] FIG. 10 is a side perspective view of a second housing with a shaft partially disposed within the lumen and rotated counterclockwise from a neutral position in accordance with an exemplary embodiment of the present technology.
[0007] Elements and steps in the figures are illustrated for simplicity and clarity and are not necessarily depicted in any particular order, for example, steps may be shown in the figures that may be performed simultaneously or in a different order to help improve understanding of embodiments of the present technology. DETAILED DESCRIPTION OF THE INVENTION
[0008] The present technology can be described in terms of functional block components and various processing steps. Such functional blocks can be realized by any number of components configured to perform the specified functions and achieve various results. For example, the present technology can be used with prosthetic limbs for various amputation types (above-the-knee, below-the-knee, etc.). Furthermore, the present technology can be implemented in conjunction with any number of materials and manufacturing methods, and the described system is merely one exemplary application of the present technology.
[0009] Although exemplary embodiments are described herein in sufficient detail to enable those skilled in the art to practice the invention, it should be understood that other embodiments may be realized, and that logical, structural, material, and mechanical changes may be made without departing from the spirit and scope of the invention. Accordingly, the following description is not intended as a limitation on the use or applicability of the invention, but instead is provided merely to enable a thorough description of exemplary embodiments.
[0010] The functions and features of a lower limb prosthesis can be selected based on the user's ability to walk and transfer from various positions, such as from a chair or bed. For patients who can walk at a single speed on a horizontal surface, a solid ankle cushion heel-foot prosthesis or a single-axis prosthesis may be selected. For users who can traverse curbs, stairs, and uneven surfaces, a flexible keel foot or multi-axis ankle / foot prosthesis may provide improved gait efficiency and safety. For users with greater rehabilitation potential, who can walk at different speeds and traverse most environmental obstacles, a multi-axis ankle-foot prosthesis with a vertical load pylon may be beneficial.
[0011] In some examples, a prosthetic assembly can be provided that allows limited axial rotation and vertical load between two housings in which the elastic body is located. The elastic body provides limited elastic vertical load and axial rotation when deformed by relative displacement and movement between the two housings. The movable shaft is attached to one of the housings and is longitudinally and rotationally movable relative to a lumen disposed within the other housing in which the shaft resides. A retaining member or assembly may be provided at the end of the shaft to releasably and movably retain the shaft within the other housing. While the shaft is typically a rigid shaft that does not bend under typical loads, in other embodiments, the shaft may include an elastically flexible shaft having one or more bending regions, e.g., helical spring regions, that can bend away from its central longitudinal axis.
[0012] To resist substantial separation of the elastic body from the housing, the elastic body can include a closed shape with an internal opening through which a portion of the shaft is disposed. To increase resistance to greater axial rotation, the housing and elastic body can include complementary protrusions and recesses configured to resist greater amounts of rotational slippage. The complementary interfaces can also be sized and positioned to distribute rotational forces acting on the elastic body to reduce force concentrations that could increase fracture or breakage of the elastic body. In some further embodiments, the assembly configuration can include protrusions from the first and second housings into recesses disposed in the elastic body. The recesses can be disposed around the periphery of the elastic body so that each recess is open and meets on both the lateral and horizontal surfaces of the elastic body. The angular arrangement of the recesses can be configured so that the recesses are disposed in alternating horizontal planes to receive alternating protrusions from the two housings. This creates a corrugated configuration on the lateral or peripheral surface of the elastic body. The elastic body may further include one or more flanges or sealing structures to help resist intrusion of water or liquids into the interior region of the assembly.
[0013] The first and second housings of the assembly may also include a recess or cavity for partially accommodating a portion of the elastic body and an interface for fixedly or movably coupling to the shaft of the assembly. In some variations, the first or upper end of the shaft is configured to be fixedly attached to the first or upper housing, such that the first housing and shaft move in a fixed relationship relative to the elastic body and the second housing. In other variations, the first housing and shaft may be integrally formed. Typically, the shaft is inserted through the elastic body and into a longitudinal lumen of the second or lower housing, within which the shaft movably resides.
[0014] The first or upper housing or the first or upper end of the shaft may include a mounting interface for attachment to a pylon or residual limb socket, and the second or lower housing may include a mounting interface for attaching the assembly to a foot prosthesis.
[0015] The second or lower end of the shaft may be accessible at the second or lower end of the second housing, and a retaining member or assembly may be attached to the shaft to retain the shaft within the lumen of the second housing. The retaining member or assembly may be removable to perform maintenance on the assembly or to replace the elastic body.
[0016] In one exemplary embodiment, as generally described above, a prosthetic assembly 100 providing vertical shock absorption and rotational movement is shown in FIGS. 1A-1H. Assembly 100 includes a resilient bumper or body 102 positioned between a first or upper housing 104 and a second or lower housing 106. A longitudinal or vertical shaft 108 is coupled to first housing 104, passes through resilient body 102, and is coupled to second housing 106. A retention member or retention assembly 110 is attached to shaft 108 to resist separation of the shaft from second housing 106. Assembly 100 is configured to allow limited longitudinal and rotational displacement of shaft 108 relative to second housing 106, with resilient body 102 providing resilient resistance to increased vertical compression and increased rotational displacement. A pyramidal mounting structure 112 is provided on the shaft 108 for mounting the assembly 100 to a pylon or residual limb socket (not shown), while the second housing 106 is configured for mounting to a foot prosthesis. A cover piece 114 may also be provided on the assembly 100. In some variations, the cover piece 114 may provide a cosmetic / trademark and / or protective function to protect one or more areas of the assembly 100 from ingress of undesirable materials (e.g., dirt, liquids) and / or inadvertent snagging of the assembly 100 by environmental and hazardous objects. While the assembly 100 described in this particular embodiment may be provided separately from the foot prosthesis, in other examples, the assembly 100 may be integrated with the foot prosthesis at the time of manufacture.
[0017] The shaft 108 is sized to pass through a lumen 122 of the lower housing 106 such that a retention member or assembly 110 can be used to releasably retain the shaft 108 within the lumen 122 .
[0018] The elastic body 102 of the assembly 100 can include a resilient material such as silicone, rubber, polyurethane, urethane, thermoplastic elastomer, or thermoplastic vulcanizate (e.g., SANTOPRENE™ and ELASTRON™). In some further embodiments, the resilient material can include a durometer ranging from 40A to 100A, or 50A to 90A, or 60A to 90A, and can be selected based on the user's weight and / or activity level. In some examples, the elastic body 102 is selected to provide a vertical deflection or compression of up to 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm or more, and a rotational deflection of up to 5 degrees, 6 degrees, 7 degrees, 8 degrees, 10 degrees, 12 degrees, 14 degrees, 16 degrees, or 20 degrees or more.
[0019] In one exemplary analysis, elastomers of various durometers were evaluated using various loads to achieve a minimum vertical deflection of 2 mm and a minimum angular deflection of 12 degrees. The results of the analysis are shown in Table 1 below.
[0020] TIFF0007744995000001.tif47127
[0021] In some examples, the density of the material of the elastic may be different or lower on the inside of the elastic relative to the exposed surface of the elastic, or the exposed surface may comprise a different material. The elastic may also include a coating to reduce water absorption into the elastic, for example, a hydrophobic or water-resistant coating.
[0022] 1A-1H, upper housing 104 includes a plurality of lower protrusions 116 extending from its perimeter surface 118 and lower surface 120. Lower protrusions 116 are positioned within and form a complementary fit with upper recesses 218 of elastic body 102. Similarly, lower housing 106 includes a plurality of upper protrusions 126 extending from its perimeter surface 130 and upper surface 132, and are positioned within and form a complementary fit with lower recesses 220 of elastic body 102. Lower housing 106 further includes a mounting interface 124 that is used to attach the assembly to a foot prosthesis (not shown).
[0023] 2A-2E , the elastic body 102 may include a first or upper surface 200, a second or lower surface 202, a central lumen 204 therebetween defining an inner surface 206, and an outer surface 208. Each of the upper and lower surfaces 200, 202 may include a generally planar configuration, but in other examples may include a concave or convex configuration, or other non-planar configuration, such as a frustoconical configuration, or a combination thereof. The central lumen 204 has a generally circular cross-sectional shape transverse to its central longitudinal axis 210, but other variations may include, for example, a triangular, square, rectangular, or elliptical shape. The diameter, lateral dimension, or surface area of the central lumen 204 may be constant or may vary along the longitudinal axis 210. As shown in the exemplary elastic body 102 of FIG. 2E , the central lumen 204 may include a larger diameter around its upper and lower regions 212, 214, but a smaller diameter around a central region 216. In this example, the transition along regions 212, 214, and 216 is gradual, such that the inner surface 206 includes a convex configuration in the cross-section of FIG. 2E, although in other examples the transition may be abrupt, for example, with a stepped surface configuration. Similarly, the outer surface 208 of the elastomeric body 102 also includes a convex shape in cross-section, although in other examples it may include a concave, linear, frustoconical, or other shape. The larger diameter may be in the range of 0.4 inches to 3.0 inches, 0.6 inches to 2.0 inches, or 0.8 inches to 1.3 inches. The smaller diameter may be in the range of 0.20 inches to 2.8 inches, 0.4 inches to 1.8 inches, or 0.7 inches to 1.2 inches, with an average diameter in the range of 0.3 inches to 2.9 inches, 0.5 inches to 1.9 inches, or 0.75 inches to 1.25 inches. The central lumen 204 may be sized such that its inner surface 206 is spaced apart and does not contact the shaft 108 during typical use. In some variations, some radially inward bulging of the inner surface 206 may be expected during vertical compression of the elastic body 102, and therefore the dimensions of the central lumen 204 may be sized sufficiently to reduce the likelihood of the inner surface 206 contacting the shaft 108 during compression.The annular gap between the inner surface 206 and the shaft 108 may range from 0.001 inches to 1.0 inches, 0.02 inches to 0.5 inches, or 0.03 inches to 0.25 inches. The average diameter or maximum lateral dimension of the body 102 across the outer surface 208 may range from 0.7 inches to 3.5 inches, 1 inch to 2.5 inches, or 1.5 inches to 2.25 inches.
[0024] 2A-2E , the exemplary elastic body 102 includes one set of upper recesses 218 and one set of lower recesses 220. The recesses in each set of recesses can include the same recess shape or configuration and can be equally spaced, but the angular orientation between the upper recesses 218 and the lower recesses 220 is offset such that the angular position of each upper recess 218 is equally spaced from the adjacent lower recess 220, just as each lower recess 220 is equally spaced from the adjacent upper recess 218. In this example, each set of recesses 218, 220 includes four recesses spaced 90 degrees around the elastic body and offset 45 degrees between the two sets of recesses 218, 220. This allows the elastic body 102 to be assembled or repaired without requiring specific angular alignment or upper / lower orientation, simplifying assembly and replacement and reducing premature wear. However, in other examples, the elastic body 102 may not have such symmetry and thus may be limited to a single or fewer positions / or orientations. In other variations, for example, one or more recesses may include a different size, shape, or spacing than other recesses in the same set, and / or the number of recesses between two sets of recesses may differ. In other examples, the number of recesses in each set of recesses may range from 2 to 5 recesses, 3 to 4 recesses, or 3 to 5 recesses.
[0025] 2A-2E , the recesses 218, 220 include angled or non-planar openings 222, 224, with portions 222a, 224a of the openings 222, 224 on the upper and lower surfaces 200, 202 of the body 102, respectively, being continuous with portions 222b, 224b of the openings 222, 224 located on the outer surface 208. Thus, each opening 222, 224 has a non-planar configuration with boundaries located on the outer surface 208 and either the upper or lower surface, with the different portions 222a, 222b, 224a, 224b being approximately perpendicular to one another. In this particular embodiment, the recesses 218, 220 include inner walls 226, 228 that prevent the recesses 218, 220 from opening into the central lumen 204 of the body 102. This configuration reduces the introduction of debris or foreign matter into the device during use and disruption of the smooth movement of the lumen 204 of the lower housing 106 and the shaft 108. This configuration also shifts, distributes, or transmits torque exerted by the upper and lower housings 104, 106 from an inner region to an outer region of the elastic body 102, thereby reducing torque forces acting on the elastic body 102 and extending its usable life before replacement is required.
[0026] Each of the recesses 218, 220 also includes side walls 230, 232 and end walls 234, 236. As shown in Figures 2A-2E, the transitions between the walls 226, 228, 230, 232, 234, 236 and the upper and lower surfaces 200, 202 of the elastic body 102 may be rounded rather than sharp. This may reduce the concentration of forces transmitted from the lower and upper extensions of the upper and lower housings 104, 106, or may distribute transmitted forces or stresses throughout the elastic body 102, thereby reducing the risk of fracture or tearing and thereby extending the life of the elastic body 102. The height 238 of each recess 218, 220 may be characterized as the distance between the upper or lower surface 200, 202 of the elastic body 102 and the corresponding end wall 234, 236, as best seen in Figure 2B. The height 238 may range from 0.1 inches to 3 inches, 0.2 inches to 1.5 inches, or 0.3 inches to 1 inch. The height 238 of each recess 218, 220 may also be characterized as a percentage of the height of the elastic body 102, e.g., the distance between the upper surface 200 and the lower surface 202. In the particular embodiment shown in FIG. 2B, each of the recesses 218, 220 has a relative height 238 of 50% of the elastic body 102, and each has an end wall 234, 236 at a midplane 240 of the elastic body 102. In other variations, the recesses may have relative heights 238 in ranges of, for example, 20% to 80%, 30% to 70%, 40% to 60%, or 50% to 70%. The width 242 of each recess 218, 220 may be an average or maximum width based on the distance between the sidewalls and may range from 0.04 inches to 1.5 inches, 0.125 inches to 1 inch, or 0.15 inches to 0.5 inches. The radial depth 244 of the recess 218, 220 may be characterized by the distance between the outer surface 208 and the inner wall 226, 228 of the recess 218, 220, as shown in FIG. 2C, and may range from 0.04 inches to 1.5 inches, 0.1 inches to 1 inch, or 0.2 inches to 0.5 inches. In some variations, the width of each recess 218, 220 between the sidewalls 230, 232 may taper radially inward, e.g., each sidewall 230, 232 is disposed in a plane intersecting the central longitudinal axis 210 of the elastic body 102.In other variations, the angle of the sidewalls 230, 232 relative to a plane may vary, for example, by approximately ±1 to ±5 degrees, ±2 to ±10 degrees, or ±4 to ±20 degrees relative to a plane intersecting the central longitudinal axis 210. In some further variations, the angle of the sidewalls 230, 232 can be varied so that the sidewalls 230, 232 are parallel, or so that the width of each recess 218, 220 is constant or increases toward the central axis, so that during rotation, the resilient member has a radial displacement force component that drives the resilient member toward the centerline. This is in contrast to sidewall angles, which can pinch portions of the body 102, generating radially outward displacement forces and potentially shortening the life of the resilient member. The radial depth 244 of the recesses 218, 220 can also be characterized as a relative percentage of the radial or annular distance 246 between the inner surface 206 and the outer surface 208 of the body 102, also shown in FIG. 2C. The relative radial depth 244 may be, for example, within a range of 30% to 90%, 40% to 80%, or 50% to 80%. The radial thickness 248 of the inner walls 226, 228 may also be characterized as the radial distance between the inner walls 226, 228 and the inner surface 206 of the central lumen 204. The radial thickness 248 may range from 0.04 inches to 2.0 inches, 0.07 inches to 1 inch, or 0.1 inches to 0.5 inches, and may also be characterized as the relative thickness 248 as a percentage of the annular distance 246. The relative thickness 248 may range, for example, from 10% to 70%, from 20% to 60%, or from 20% to 50%. These dimensions are measured based on average dimensions and may exclude curved regions of the recesses 218, 220 at transitions between different walls and surfaces.
[0027] 5A-5F show further details of the upper housing 104 of the assembly 100 shown in FIGS. 1A-1H. As previously described, the upper housing 104 includes a plurality of lower protrusions 116 extending from its peripheral surface 118 and lower surface 120. When assembled, the lower protrusions 116 are positioned within and complementarily mate with the upper recesses 218 of the elastic body 102. In this exemplary embodiment, the peripheral surface 118 includes a convex tapered shape having a larger diameter or lateral dimension in a lower region 500 proximate the lower protrusions 116 and lower surface 120 and a reduced diameter or lateral dimension in an upper region 502 of the upper housing 104. Due to the taper, the upper surface 128 has a minimum or substantially reduced surface area compared to the lower surface 120. However, in other variations of the upper housing 104, the perimeter 118 may not be tapered, or may include a generally cylindrical shape, or may include a non-circular or polygonal shape with linear or vertically oriented surfaces.
[0028] The average length 506, average width 508, and average radial depth 510 of each lower projection 116 may be complementary to the size of the corresponding recess 218. In some variations, the dimensions 506, 508, 510 of each lower projection 116 may be slightly smaller or larger than the dimensions 238, 242, 244 of the recess 218. In some examples, the inner surface 512 of each lower projection 116 may have a generally perpendicular or parallel orientation relative to the central longitudinal axis 210 of the upper housing 104. The outer surface 514 of each lower projection 116 may include a taper that is continuous with the taper and / or curvature of the circumferential surface 118 and may be flush with, concave, or protruding from the portion of the recess 218 on the outer surface 208 of the elastomeric body 102. Similar to recess 218 , lower projection 116 may include rounded edges between lower surface 120 , inner surface 512 , outer surface 514 , and transitions of side wall 516 and end wall 518 .
[0029] The upper housing 104 further includes a central lumen 504 between the lower surface 120 and the upper surface 128. The central lumen 504 is configured to receive the longitudinal shaft 108 of the assembly 100. As shown in FIG. 5D , the central lumen 504 includes an upper region 504a of reduced size and a lower region 504b of enlarged size, with a stepped surface 504c therebetween. The upper region 504a may include a threaded interface for attaching the shaft 108 to the upper housing 104, although in variations, the lower region 504b or both regions 504a, 504b may include threads, or other types of mounts (e.g., bayonet mounts) may be provided between the upper housing and the shaft. An adhesive, such as an acrylate or cyanoacrylate, may also be applied to the threaded interface to resist separation from torsional forces acting through the shaft.
[0030] As shown in FIGS. 1A-1H and 6A-6C, a pyramid mounting structure 112 is provided on the shaft 108 for mounting the assembly 100 to a pylon or residual limb socket. The pyramid 112 typically includes an industry-standard four-way configuration, but in other instances may include alternative or proprietary designs. The pyramid configuration can be varied by using a different shaft with a different pyramid configuration. Referring to FIGS. 6A-6C, the pyramid 112 is disposed at a first end 600 of the shaft 108 and may include a threaded bore 602 to facilitate mounting of the pyramid 112. Adjacent to the pyramid 112 is a mounting area or interface 604 on the shaft 108 that forms a complementary fit with the central bore 504 of the upper housing 104. This may be a threaded interface, as shown, or a bayonet mount or other type of mechanical or friction fit, as described above. As shown in FIGS. 1A-1H , the shaft 108 may be configured such that, when assembled with the upper housing 104, the pyramid 112 protrudes from the top surface 128 of the upper housing 104. Adjacent to the attachment interface 604 of the shaft 108 may be a tool interface 606, which may be used to grip the shaft 108 with a wrench, pliers, or other tool when coupling or separating the shaft 108 and the upper housing 104. While the tool interface 606 shown in FIGS. 6A-6C is a hexagonal interface, in other variations, the tool interface 606 may be square, rectangular, or other polygonal, or may include an internal cavity into which a torque bar may be inserted to facilitate rotational coupling and separation of the shaft 108 and the upper housing 104.
[0031] In yet another variation of assembly 900, upper housing 902 and shaft 904 and pyramid 906 may be integrally formed as a monolithic component, as shown in Figure 9. In yet another example, as shown in Figure 10, assembly 1000 may include a pyramidal structure 1002 that is integrally formed with upper housing 1004 of assembly 1000 but has a recess or lumen 1006 in upper housing 1004 for coupling to shaft 1008. In this particular embodiment, lumen 1006 in upper housing 1004 is open at both ends and is located through pyramid 1002 and body 1008 of upper housing 1004, although in other variations, lumen 1006 is closed ended and has only a lower opening 1010 of the lumen, with an upper opening 1012 in pyramid 1002.
[0032] 6A-6E , adjacent to or below the tool interface 606 of the shaft 108 is the body 608 of the shaft 108, which is configured to reside and move within the lumen 122 of the lower housing 106 when assembled. The length of the body 608 of the shaft 108 may range from 1.0 inches to 7.0 inches, 2.0 inches to 5.0 inches, or 2.0 inches to 4.0 inches. The diameter or cross-sectional dimension of the shaft 108 may range from 0.12 inches to 1.5 inches, 0.25 inches to 1.25 inches, or 0.3 inches to 0.9 inches. Different lengths of the shaft 108 may also be provided to accommodate different patient preferences, heights, and functional levels, with corresponding different heights of the elastic body 102.
[0033] The second or lower end 610 of the shaft 108 is sized and configured to extend out of the lumen 122 of the lower housing 106. A retention member or assembly 110 may be attached to the second end 610 to resist withdrawal of the shaft 108 from the lower housing 106, but may also be configured to allow some vertical displacement of the shaft 108 within the lumen 122. This acts as a shock absorber, as the upper and lower housings 104, 106 resiliently compress the elastic body 102. In this particular example, the retention assembly 110 is attachable to the second end 610 of the shaft 108 via a closed, threaded lumen 612, although in other variations, it may be attached via a clevis pin or other coupling interface. The retention assembly 110 is also configured to allow the shaft 108 to rotate within the lumen 122, thereby allowing axial rotation. 1A-1H, axial rotation is limited by the increased resistance to rotation provided by rotational compression of elastic body 102 between lower projection 116 and upper projection 126. However, in other variations, retaining member or assembly 110, shaft 108 and / or lower housing 106 may be configured with one or more complementary flanges and recesses to provide a tight limiting angular limit on the range of rotation.
[0034] Referring now to the lower housing 106, detailed in FIGS. 7A-7H , as previously described, the lower housing 106 includes a plurality of upper protrusions 126 extending from its peripheral surface 130 and upper surface 132. The upper protrusions 126 are positioned and configured to form a complementary fit with the lower recesses 220 of the elastic body 102. The lower housing 106 further includes a longitudinal bore 122 for receiving the shaft 108. The lower housing 106 includes a body 700 in which the bore 122 resides, and also includes the prosthesis attachment interface 124 previously described. The bore 122 may include a lubricant or lubricious coating to facilitate longitudinal and rotational movement of the shaft 108 therein, although in some examples, a tubular bearing, such as a SPRINGGLIDE™ bearing (Saint-Gobain, Courbevoie, France), may be provided to facilitate such movement.
[0035] Similar to the lower projections 116 of the upper housing 104, the average length 704, average width 706, and average radial depth 708 of each upper projection 126 may be complementary to the size of the corresponding recess 220 in the elastomeric body 102. In some variations, the dimensions 704, 706, 708 of each upper projection 126 may be slightly smaller or larger than the dimensions 704, 706, 708 of the recess 220. In some examples, as shown in FIG. 7C , the inner surface 714 of each upper projection 126 may have a generally perpendicular or parallel orientation relative to the longitudinal axis of the upper housing 104. The outer surface 716 of each upper projection 126 may include a taper that is continuous with the taper and / or curvature of the circumferential surface 132 and may be flush with, concave, or protruding from the portion of the recess 220 on the outer surface 208 of the elastomeric body 102. Similar to the recess 220, the upper projection 126 may include rounded edges between the transition of the top surface 132 of the lower housing 106 and the inner surface 714, outer surface 716, side wall 718 and end wall 720 of the upper projection 126.
[0036] The upper surface 132 of the lower housing 106 can include a configuration similar to the lower surface 120 of the upper housing 104, but with an angular offset relative to the protrusion 126. However, in the embodiment shown in FIGS. 7A-7E , the upper surface 132 further includes an annular protrusion or flange 710. The annular flange 710 is spaced radially inward from the circumferential surface 130 and the upper protrusion 126 and surrounds the longitudinal lumen 122 of the lower housing 106. This flange 710 can be configured to insert into or reside within the central lumen 204 of the elastomeric body 102. In some variations, the annular flange 710 can reduce the risk of eccentric displacement of the elastomeric body 102 during various compression and rotational movements, can also limit radially inward bulging of the inner surface 206 during vertical compression, and / or can act as a barrier to reduce the intrusion of debris and liquid into the lumen 122 of the lower housing 106. The flange 710 also provides additional support for longer tubular bearings that may be used in the bore 122. The use of longer bearings can increase or decrease resistance that may be generated by off-axis forces across the longitudinal shaft and bore. This may also improve bearing life and tactile prosthesis response. In embodiments including tubular bearings, the ratio of bearing length to bearing inner diameter may range from 1.5:1 and 10:1, or from 2:1 to 6:1, or from 3:1 to 5:1. The flange 710 also allows the resilient member to be positioned lower across the prosthesis relative to the bore 122, thereby reducing the build height of the prosthesis and allowing the prosthesis to be used over a wider range of residual limb lengths. Depending on the height of the annular flange 710, the flange 710 can also provide a hard compression stop if the amount of vertical compression causes the annular flange 710 to abut against the underside 120 of the upper housing 104. In some variations, the height of the annular flange 710 ranges from 0.02 inches to 1.5 inches, 0.1 inches to 0.5 inches, or 0.12 inches to 0.3 inches. The wall thickness of the flange 710 may range from 0.04 inches to 0.5 inches, 0.07 inches to 0.3 inches, or 0.1 inches to 0.2 inches.The inner diameter may be 0.25 inches to 1.5 inches, 0.3 inches to 1.0 inches, or 0.5 inches to 0.75 inches, and the outer diameter may be 0.3 inches to 2.0 inches, 0.4 inches to 1.5 inches, or 0.5 inches to 1.0 inches.
[0037] The peripheral surface 130 of the lower housing 106 may also include a convex tapered shape with a larger diameter or lateral dimension in the upper anterior region 702. The mounting interface 124 of the lower housing 106 may include a flat, vertically flat surface to facilitate mounting of the lower housing 106 to a foot prosthesis, although in other variations, the lower housing 106 may include angled or horizontal regions to facilitate mounting to a foot prosthesis having a corresponding angled or horizontal mounting site.
[0038] The mounting interface 124 of the lower housing 106 includes one or more threaded bores 712 to facilitate attachment of the lower housing 106 to a foot prosthesis using screws, bolts, or other fasteners. In Figures 3A-3E, the assembly 100 is attached to a foot prosthesis 300 using bolts 302, 304 with the vertically mounted mounting interface.
[0039] 7A , the attachment interface 124 of the lower housing 106 may also include a cover attachment site 722 that facilitates attachment of the cosmetic cover 114 to the body 700 of the lower housing 106. The lumen 122 of the lower housing 106 may include a retention cavity 724 in which the retention assembly 110 resides. However, in other variations, no retention cavity is provided so that the retention assembly 110 can protrude from the lumen 122 and the lower housing 106.
[0040] As previously mentioned, the retention member or assembly 110 can be attached to the shaft 108 using the threaded bore 612 at the lower end of the shaft 108, as shown in FIG. 1H. The retention assembly 110 can include a bolt 800 or other type of fastener and a retention washer 802 movable within the retention cavity 724. The retention washer 802 resists further upward displacement of the shaft 108 when the shaft abuts the upper surface of the retention cavity 724. The retention washer 802 includes a washer cavity 804 for receiving the bolt 800 and can include a reduced-diameter shaft cavity 804a and an enlarged head cavity 804b that allows the bolt 800 to have a partially recessed position within the retention washer 802 when attached to the shaft 108. An O-ring or annular sliding seal 806 can be provided on the retention washer 802 to reduce the risk of debris and liquid impeding movement of the shaft 108 within the bore 122 of the lower housing 106. Seal 806 is maintained in a slidable configuration with retention cavity 724 by a seal recess 808 on retention washer 802, bounded by recess walls 808a and 808b, as shown in FIGS. 8A-8F. Retention washer 802 may also include a spring recess 810 on or proximal to recess wall 808a. Referring again to FIG. 1H, spring recess 810 allows for positioning of spring 812, which can be used to provide some limited downward bias against shaft 108, maintaining elastomer 102 with a minimal amount of compression relative to assembly 100. This minimal compression can be useful if or when elastomer 102 is subject to permanent compression or compression set during use. Spring 812 may be, for example, a helical spring or wave washer. Seal 804 may include silicone, Buna-N rubber, and fluorinated elastomers such as VITON™ (Chemours, Wilmington, Delaware).
[0041] 4A-4F show the assembled configuration of the upper housing 104, the lower housing 106, and the shaft 108, excluding the elastic body 102. The shaft 108 may be configured so that the tool interface 610 is positioned generally at the height of the longitudinal position of the elastic body 102. The gap or distance between the lower surface 120 of the upper housing 104 and the upper surface 132 of the lower housing 106 may be equal to the unstrained height of the elastic body 102. In other examples, the gap or distance may be less than the unstrained height of the elastic body 102, such that when assembled, the upper housing 104 and the lower housing 106 place the elastic body 102 in baseline vertical compression. This baseline compressed configuration may make the tactile sensation of the assembly more linear or predictable compared to a baseline configuration in which there is no compression or the housing gap is greater than the unstrained height of the elastic body 102.
[0042] The upper housing 104, the lower housing 106, the shaft 108 and / or the cover piece 114 may comprise stainless steel (e.g., 17-4 stainless steel), titanium or cobalt chrome, aluminum or other metals, and anodized variations thereof, but in other examples may comprise rigid polymers, ceramics, or composites thereof.
[0043] In another exemplary embodiment, shown in FIGS. 11A and 11B, a prosthetic assembly 1100 is shown providing vertical shock absorption and rotational movement. The assembly 1100 includes many similar components to the prosthetic assembly 100 described above, which will not be described in detail below. The assembly 1100 includes a resilient bumper or body 102 positioned between a first or upper housing 104 and a second or lower housing 1102. A longitudinal or vertical shaft 1104 is coupled to the first housing 104, passes through the resilient body 102, and is coupled to the lower housing 1102. A retention member or retention assembly 110 is attached to the shaft 1104 to resist separation of the shaft 1104 from the lower housing 1102. The assembly 1100 is configured to allow limited longitudinal and rotational displacement of the shaft 1104 relative to the lower housing 1102, with the resilient body 102 providing resilient resistance to increased vertical compression and increased rotational displacement.
[0044] The shaft 1104 is sized to pass through a lumen 1106 of the lower housing 1102 such that a retention member or assembly 110 can be used to releasably retain the shaft 1104 within the lumen 1106 .
[0045] As shown in FIGS. 11A-11B and 13A-13E, a pyramid mounting structure 1108 is provided on the shaft 1104 for mounting the assembly 1100 to a pylon or residual limb socket. The pyramid 1108 typically includes an industry-standard four-way configuration, but in other instances may include alternative or proprietary designs. The pyramid configuration can be varied by using a different shaft with a different pyramid configuration. Referring to FIGS. 13A-13E, the pyramid 1108 is disposed at a first end 1110 of the shaft 1104 and may include a threaded bore 1112 to facilitate mounting of the pyramid 1108. Adjacent to the pyramid 1108 is a mounting area or interface 1114 on the shaft 1104 that forms a complementary fit with the central bore 504 of the upper housing 104. This may be a collar interface as shown, or a threaded interface as described above, a bayonet mount, or other types of mechanical or friction fit as described above. 11A-11B, the shaft 1104 may be configured such that, when assembled with the upper housing 104, the pyramid 1108 protrudes from the top surface 128 of the upper housing 104. Adjacent to the attachment interface 1114 of the shaft 1104 may be a bore interface 1116 that may be used to grip the shaft 1104 with a wrench or pliers or other tool when connecting or disconnecting the shaft 1104 and the upper housing 104.
[0046] The bore interface 1116 may include at least one contact surface 1126 configured to contact a rounded protrusion on the flange of the lower housing to limit torsional rotation between the upper housing 104 and the lower housing 1102, as described further below. While the contact surface 1126 shown in FIGS. 13A-13E is a rectangular interface, in other variations, the contact surface 1126 of the bore interface 1116 may be square, hexagonal, or other polygonal, or may include an internal cavity into which a torque bar may be inserted to facilitate rotational coupling and decoupling of the shaft 1104 and the upper housing 104. The contact surface 1126 of the bore interface 1116 on the shaft 1104 is configured to provide a hard, finite angular limit on the range of rotation relative to the lower housing 1102, as shown in FIGS. 18 and 19 . The contact surface 1126 may be configured in any suitable shaft to cooperate with an internal configuration of the flange of the lower housing 1102.
[0047] Referring again to FIGS. 13A-13E , adjacent to or below the bore interface 1116 of the shaft 1104 is the body 1118 of the shaft 1104, which is configured to reside and move within the lumen 1106 of the lower housing 1102 when assembled. The length of the body 1118 of the shaft 1104 may range from 1.0 inches to 7.0 inches, 2.0 inches to 5.0 inches, or 2.0 inches to 4.0 inches. The diameter or cross-sectional dimension of the shaft 1104 may range from 0.12 inches to 1.5 inches, 0.25 inches to 1.25 inches, or 0.3 inches to 0.9 inches. In one embodiment, the diameter of the shaft may be approximately 0.55 inches, and the length of the body of the shaft may be approximately 3.83 inches. Different lengths of the shaft 1104 may also be provided to accommodate different patient preferences, heights, and functional levels, with corresponding different heights of the elastic body 102.
[0048] The second or lower end 1120 of the shaft 1104 is sized and configured to extend out of the lumen 1106 of the lower housing 1102. A retention member or assembly 110 may be attached to the second end 1120 to resist withdrawal of the shaft 1104 from the lower housing 1102, but may be configured to allow some vertical displacement of the shaft 1104 within the lumen 1106. This acts as a shock absorber, as the upper and lower housings 104, 1102 resiliently compress the elastic body 102. In this particular example, the retention assembly 110 is attachable to the second end 1120 of the shaft 1104 by a closed, threaded lumen 1122, although in other variations, it may be attached via a clevis pin or other coupling interface. The retention assembly 110 is also configured to allow the shaft 1104 to rotate within the lumen 1106, thereby allowing axial rotation.
[0049] 1A-1H, axial rotation is limited by the increased resistance to rotation provided by rotational compression of elastic body 102 between lower projection 116 and upper projection 126. However, in other variations, retaining member or assembly 110, the contact surfaces of the bore interface on shaft 108, and the rounded protrusions on the flange of lower housing 106 may be configured to provide a hard limiting angular limit on the range of rotation.
[0050] 14A, 14B, and 15, the lower housing 1102 may include an annular protrusion or flange 1124. The remaining components of the lower housing 1102 are similar to those described above with respect to the lower housing 106.
[0051] An annular flange 1124 is spaced radially inward from the circumferential surface 130 and the protrusion 126 and surrounds the longitudinal lumen 1106 of the lower housing 1102. This flange 1124 may be configured to insert into or reside inside the central lumen 204 of the body 102. In some variations, the annular flange 1124 can reduce the risk of eccentric displacement of the body 102 during various compression and rotational movements, can also limit radially inward bulging of the inner surface 206 during vertical compression, and / or can act as a barrier to reduce the intrusion of debris and liquid into the lumen 1106 of the lower housing 1102.
[0052] The flange 1124 also provides additional support for longer tubular bearings that may be used in the bore 1106. The use of longer bearings can increase or reduce resistance that may be generated by off-axis forces or forces across the longitudinal shaft 1104 and bore 1106. This may also improve bearing life and tactile prosthesis response. In embodiments including tubular bearings, the ratio of bearing length to bearing inner diameter may range from 1.5:1 and 10:1, or from 2:1 to 6:1, or from 3:1 to 5:1. The flange 1124 also allows the resilient member to be positioned lower across the prosthesis relative to the bore 1106, thereby reducing the build height of the prosthesis and allowing the prosthesis to be used over a wider range of residual limb lengths. Depending on the height of the annular flange 1124, the flange 1124 can also provide a hard compression stop if the amount of vertical compression causes the annular flange 1124 to abut against the underside 120 of the upper housing 104. In some variations, the height of the annular flange 1124 ranges from 0.02 inches to 1.5 inches, 0.1 inches to 0.5 inches, or 0.12 inches to 0.3 inches. The wall thickness of the flange 1124 may range from 0.04 inches to 0.5 inches, 0.07 inches to 0.3 inches, or 0.1 inches to 0.2 inches. The inner diameter may be from 0.25 inches to 1.5 inches, 0.3 inches to 1.0 inches, or 0.5 inches to 0.75 inches, and the outer diameter may be from 0.3 inches to 2.0 inches, 0.4 inches to 1.5 inches, or 0.5 inches to 1.0 inches. In one embodiment, the flange height may be approximately 0.47 inches, and the outer diameter may be approximately 0.92 inches. In one embodiment, in the protruding design, the wall thickness of the flange 1124 may be irregular within the range of 0.16 to 0.60 inches, with the inside of the protruding feature having an inscribed circle diameter of a minimum of about 0.599 inches to a maximum of about 0.800 inches.
[0053] 12A-12D show the assembled configuration of the upper housing 104, the lower housing 1102, and the shaft 1104, excluding the elastic body 108. The shaft 1104 may be configured so that the bore interface 1116 is generally at the height of the longitudinal position of the elastic body 102. The gap or distance between the lower surface 120 of the upper housing 104 and the upper surface of the lower housing 1102 may be equal to the unstrained height of the elastic body 102. In other examples, the gap or distance may be less than the unstrained height of the elastic body 102, such that when assembled, the upper housing 104 and the lower housing 1102 place the elastic body 102 in baseline vertical compression. This baseline compressed configuration may make the tactile sensation of the assembly more linear or predictable compared to a baseline configuration in which there is no compression or the housing gap is greater than the unstrained height of the elastic body 102.
[0054] 14 and 15 , the flange 1124 can include an internal bore 1128 having a plurality of rounded protrusions 1130. The rounded protrusions 1130 and the contact surfaces 1126 of the bore interface 1116 on the shaft 1104 are configured to limit rotation of the upper housing 104 relative to the lower housing 1102. The rounded protrusions 1130 are spaced apart and positioned opposite one another on the internal bore 1128. In one embodiment, the internal bore 1128 can include four rounded protrusions configured to contact the four contact surfaces 1126 of the bore interface 1116 on the shaft 1104.
[0055] In various embodiments, the contact surfaces 1126 of the bore interface 1116 on the shaft 1104 and the rounded protrusions 1130 on the flange 1124 of the lower housing 1104 may be configured to provide hard, limiting angular limits on the range of rotation, as shown in Figures 18 and 19. In one embodiment, the angular limits of rotation are approximately 15° in the clockwise and counterclockwise directions for a total range of rotation of approximately 30°. In various embodiments, the number of contact surfaces 1126 of the bore interface 1116 on the shaft 1104 is the same as the number of rounded protrusions 1130 on the flange 1124.
[0056] 17 shows the lower housing 1102 with the shaft 1104 in a neutral position with a portion of the shaft 1104 disposed within the bore 1106. The contact surface 1126 of the bore interface 1116 is not in contact with the rounded protrusion 1130 on the flange 1124 of the lower housing 1102.
[0057] 18 is a side perspective view of the lower housing 1102 with the shaft 1104 partially disposed within the bore 1106 and rotating clockwise from a neutral position. The contact surface 1126 of the bore interface 1116 contacts a rounded protrusion 1130 on the flange 1124 of the lower housing 1102 to resist torsional rotation of the upper housing 104 attached to the shaft 1104 relative to the lower housing.
[0058] 19 is a side perspective view of the lower housing 1102 with a portion of the shaft 1104 disposed within the bore 1106 rotating counterclockwise from a neutral position. The contact surface 1126 of the bore interface 1116 contacts a rounded protrusion 1130 on the flange 1124 of the lower housing 1102 to resist torsional rotation of the upper housing 104 attached to the shaft 1104 relative to the lower housing.
[0059] The specific examples and descriptions herein are exemplary in nature and variations may be developed by those skilled in the art based on the material taught herein without departing from the scope of the present subject matter.
[0060] The present technology has been described with reference to specific exemplary embodiments. However, various modifications are possible without departing from the scope of the present technology. The description and drawings should be considered in an illustrative manner, not limiting, and all such modifications are intended to be included within the scope of the present technology. Thus, the scope of the present technology should be determined by the general embodiments described and their legal equivalents, rather than solely by the specific examples described above. For example, the steps recited in any method or process embodiment may be performed in any order unless expressly specified otherwise, and are not limited to the explicit order presented in the particular example. Furthermore, the components and / or elements recited in any apparatus embodiment may be assembled or otherwise operably configured in various permutations to produce substantially the same results as the present technology, and therefore are not limited to the specific configurations recited in the particular example.
[0061] Although benefits, other advantages, and solutions to problems have been described above with respect to particular embodiments, any benefit, advantage, solution to a problem, or any element that may give rise to or make more pronounced a particular benefit, advantage, or solution should not be construed as a critical, required, or essential feature or component.
[0062] As used herein, the terms "comprises," "comprising," or any variation thereof, are intended to refer to a non-exclusive inclusion, such that a process, method, article, composition, or apparatus that includes a list of elements does not include only the enumerated elements, but may also include other elements not expressly enumerated or inherent to such process, method, article, composition, or apparatus. In addition to those not specifically enumerated, other combinations and / or modifications of the above-described structure, arrangement, application, proportions, elements, materials, or components used in the practice of the present technology may be changed or otherwise specifically adapted to particular environments, manufacturing specifications, design parameters, or other operating requirements without departing from the general principles thereof.
[0063] Furthermore, in understanding the scope of the present invention, the term "comprising" and its derivatives as used herein are intended to be open-ended terms that specify the presence of stated features, elements, components, groups, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, and / or steps. The same also applies to words of similar meaning, such as "including," "having," and their derivatives. As used herein, any terms of degree, such as "substantially," "about," and "approximate," mean a reasonable amount of deviation from the modified term such that the end result does not significantly change. For example, these terms can be interpreted as including a deviation of at least ±5% from the modified term if this deviation does not negate the meaning of the modified word.
[0064] The present technology has been described above with reference to preferred embodiments. However, changes and modifications can be made to the preferred embodiments without departing from the scope of the technology. These and other changes or modifications are intended to be included within the scope of the technology, as set forth in the following claims.
Claims
1. 1. A prosthetic assembly comprising: a resilient, undulating body including a periphery, a first surface, a second surface opposite the first surface, and an interior opening therebetween; a longitudinal shaft disposed within the internal opening of the undulating body, the longitudinal shaft including a bore interface having at least one contact surface; a first prosthetic body coupled to the longitudinal shaft and contacting the first surface of the undulating body; a second prosthetic body contacting the second surface of the undulating body, a longitudinal lumen; a flange disposed on a top surface of the second prosthetic body including an internal bore having at least one protrusion; and a second prosthetic body including: Including, the longitudinal shaft is movably disposed in the longitudinal lumen, and the at least one contact surface contacts the at least one protrusion to limit rotation of the first prosthetic body relative to the second prosthetic body.
2. The prosthetic assembly of claim 1 , wherein the at least one contact surface of the bore interface comprises a plurality of contact surfaces.
3. The prosthetic assembly of claim 2 , wherein the plurality of contact surfaces comprises a rectangular shape.
4. The prosthetic assembly of claim 3 , wherein the at least one protrusion on the internal bore comprises a plurality of protrusions.
5. 5. The prosthetic assembly of claim 4, wherein the at least one protrusion on the internal bore comprises a plurality of protrusions configured to contact the contact surface of the bore interface to resist torsional rotation of the first prosthetic body relative to the second prosthetic body.
6. The prosthetic assembly of claim 1 , wherein the undulating body includes a first plurality of recesses in the first surface of the undulating body.
7. 7. The prosthetic assembly of claim 6, wherein the first prosthetic body includes a first plurality of protrusions configured to form a mechanical fit with the first plurality of recesses of the undulating body.
8. The prosthetic assembly of claim 7 , wherein the undulating body includes a second plurality of recesses in the second surface of the undulating body.
9. 10. The prosthetic assembly of claim 8, wherein the second prosthetic body includes a second plurality of protrusions configured to form a mechanical fit with the second plurality of recesses of the undulating body.
10. 9. The prosthetic assembly of claim 8, wherein the first plurality of recesses are rotationally offset from the second plurality of recesses when no net rotational force is acting on the undulating body.
11. the first plurality of recesses include equal angular spacing relative to a central axis of the undulating body; The prosthetic assembly of claim 10 , wherein the second plurality of recesses comprises equal angular spacing relative to the central axis of the undulating body.
12. 12. The prosthetic assembly of claim 11, wherein the angular spacing of the first plurality of recesses and the angular spacing of the second plurality of recesses is 90 degrees.
13. 13. The prosthetic assembly of claim 12, wherein the first plurality of recesses and the second plurality of recesses are offset by 40 to 65 degrees.
14. 10. The prosthetic assembly of claim 1, wherein the undulating body further includes an internal seal extending from the second surface of the undulating body radially offset from the outer periphery of the undulating body and surrounding the internal opening of the undulating body.
15. 9. The prosthetic assembly of claim 8, wherein the first plurality of recesses and / or the second plurality of recesses each include four recesses.
16. 9. The prosthetic assembly of claim 8, wherein each recess of the first plurality of recesses and the second plurality of recesses includes an outer circumferential open area, a radially inward wall opposite the outer circumferential open area, and opposing first and second side walls adjacent the radially inward wall.
17. 17. The prosthetic assembly of claim 16, wherein the radially inward wall and the opposing first and second side walls comprise a U-shape on a transverse plane through the undulating body.
18. 18. The prosthetic assembly of claim 17, wherein each of the recesses of the first plurality of recesses further comprises a first surface open area on the first surface of the undulating body that is continuous with the circumferential open area of the same recess, and an intermediate wall opposite the first surface open area that is adjacent to the first and second side walls of the same recess.
19. 19. The prosthetic assembly of claim 18, wherein each of the recesses of the second plurality of recesses further comprises a second surface open area on the second surface of the undulating body, the second surface open area being continuous with the circumferential open area of the same recess, and an intermediate wall opposite the second surface open area, the intermediate wall being adjacent the first and second side walls of the same recess.
20. 17. The prosthetic assembly of claim 16, wherein each recess of the first plurality of recesses and the second plurality of recesses includes a non-planar surface opening.
21. The prosthetic assembly of claim 1 , wherein the first prosthetic body is integrally formed with the longitudinal shaft.
22. 10. The prosthetic assembly of claim 1, wherein the second prosthetic body is configured to allow axial and rotational movement of the longitudinal shaft within the longitudinal lumen of the second prosthetic body.
23. 23. The prosthetic assembly of claim 22, further comprising a shaft retainer removably attached to the longitudinal shaft and configured to resist separation between the longitudinal shaft and the second prosthetic body.
24. The shaft retainer is a removable fastener configured to removably attach to the longitudinal shaft; an annular seal configured to slidably seal the shaft retainer to the second prosthetic body; a retaining washer having a circumferential recess in which the annular seal partially resides; 24. The prosthetic assembly of claim 23, comprising:
25. 25. The prosthetic assembly of claim 24, wherein the shaft retainer further comprises a spring.
26. 26. The prosthetic assembly of claim 25, wherein the spring is configured to maintain partial compression of the undulating body when the prosthetic assembly is in an unloaded state.
27. The prosthetic assembly of claim 1 further comprising a mounting pyramid.
28. 28. The prosthetic assembly of claim 27, wherein the mounting pyramid is integrally formed with the longitudinal shaft.
29. The prosthetic assembly of claim 1 , wherein the second prosthetic body further includes a mounting interface configured for attachment to a foot prosthesis.
30. 30. The prosthetic assembly of claim 29, wherein the attachment interface includes a plurality of lumens, each lumen configured to removably receive a fastener.
31. 31. The prosthetic assembly of claim 30, wherein the plurality of lumens are a plurality of transverse lumens.
32. The prosthetic assembly of claim 1 , wherein the second prosthetic body further includes an annular cavity for at least partially receiving the undulating body.
33. The prosthetic assembly of claim 1 , wherein the diameter of the internal opening of the undulating body is greater than the diameter of the longitudinal shaft located in the internal opening of the undulating body.
34. 10. The prosthetic assembly of claim 1, wherein the longitudinal shaft includes a transverse stop surface located between a first end and a second end of the longitudinal shaft and configured to displaceably abut a corresponding stop surface on the second prosthetic body.
35. 10. The prosthetic assembly of claim 1, further comprising a compression collar disposed between the first prosthetic body and the second prosthetic body and configured to limit displacement of the longitudinal shaft relative to the longitudinal lumen of the second prosthetic body.
Citation Information
Patent Citations
Prosthetic leg
JP2003250823A
Vacuum pump for prosthetic devices with shock absorption and controlled rotation
JP2007533413A
Implants
JP2021515649A
Multi-axial fitting with shock absorption for prosthetic foot
US20050261783A1
Compression heel prosthetic foot
US20180042737A1