Adjustable socket system

Abstract

A prosthetic socket (100) that is adapted to fit to a residual limb adjustably with a textile-based sleeve (116). The prosthetic socket (100) includes a tensioning system (150) that cooperates with the sleeve (116) and allows for major and minor adjustments of circumferential cable (124) tension around the prosthetic socket (100).

Description

ADJUSTABLE SOCKET SYSTEM

[0001] INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

[0002] The pending application incorporates herein by reference the following patents and applications: U.S. patent no. 8,795,385, granted on August 5, 2014; U.S. patent no. 9,050,202, granted on June 9, 2015; U.S. patent no. 9,962,273, granted on May 8, 2018; U.S. patent no. 10,806,607, granted on October 20, 2020; U.S. patent no. 10,828,180, granted on November 10, 2020; U.S. patent no. 10,940,028, granted on March 9, 2021 ; U.S. patent no. 10,966,851 , granted on April 6, 2021 ; U.S. patent no. 11,185,430, granted on November 30, 2021; U.S. patent no. 11,547,589, granted on January 10, 2023; U.S. application no. 17 / 890,748, filed August 18, 2022; U.S. provisional application no. 63 / 490,075, filed on March 14, 2023; U.S. provisional application no. 63 / 671 ,609, filed on July 15, 2024; and U.S. provisional application no. 63 / 775,050, filed March 20, 2025.

[0003] TECHNICAL FIELD100041 The disclosure relates to an adjustable socket system for a residual limb.

[0005] BACKGROUND

[0006] A typical prosthetic leg and foot includes a socket, pylon, and foot. The socket is often defined as the part of a prosthesis that fits around and envelops a residual limb or stump and to which prosthetic components, like a foot, are attached. Fitting and aligning the socket are challenging tasks that demand extensive knowledge, training, and skill from the prosthetist.

[0007] The socket should fit snugly against the stump to provide a firm connection and support, yet it must also be loose enough to allow for circulation. In conjunction with proper fitting, the socket needs to transfer loads from the residual limb to the ground in a comfortable manner.

[0008] Conventional sockets are generally rigid and may feature a uniform shape that accommodates a significant portion of the residual limb. These sockets are permanently molded into a customized, static shape, which does not consider fluctuations in shape and volume of the residual limb. When such fluctuations occur, fitting the socket becomes hindered, often resulting in discomfort, pain, and soft tissue breakdown of the stump. Additionally, conventional sockets tend to be bulky and cumbersome to wear and can be challenging to put on, which can make the residual limb uncomfortable when worn. Additionally, protruding components like knobs and bolts of existing sockets are visible beneath clothing worn over thesocket. These protruding elements can snag and tear clothing during the donning and doffing of the prosthetic device, potentially compromising the fabric's structural integrity time.

[0009] Efforts have been made to develop adjustable sockets with individual components that can be varied in size and shape to accommodate fluctuations in the volume and shape of the residual limb. However, these adjustable sockets often include labor-intensive and complicated tightening systems for donning and doffing, making them difficult for patients with limited dexterity, cognitive abilities, and strength. These issues can lead to unsafe and improper socket use, resulting in discomfort and injury.

[0010] Some tightening systems need tools (e.g., a wrench) and a certified prosthetist / orthotist (CPO) for adjustments, which prevents users from making quick alterations while wearing the socket. Additionally, some traditional sockets that use a lanyard-like mechanism do not allow for sufficient displacement, requiring the user to attach the liner to the lanyard at an inconvenient distal end of the prosthetic socket. This manipulation at the interior distal end complicates successful attachment of the liner for suspension.

[0011] Conventional sockets are known to inadequately address shape and volume fluctuations of a residual limb. They also tend to be bulky and cumbersome to wear. While known adjustable socket systems may provide better accommodation for these fluctuations than conventional sockets, they often lack comfort and adequate support. Existing sockets do not offer low-profile methods for significant and minor adjustments to tension the devices.

[0012] For instance, sockets that utilize a tensioning dial necessitate numerous rotations to adjust the tension, making it difficult for the amputee to reach their preferred setting. Therefore, an adjustable socket is needed to comfortably adapt to the shape and volume fluctuations of the residual limb while providing improved support and stability.

[0013] Given the previous discussion, there is a need for an enhanced adjustable socket system that addresses the shortcomings of existing systems sockets.

[0014] SUMMARY

[0015] In a first aspect, a prosthetic socket is provided that is designed to fit a residual limb adjustably. The prosthetic socket includes a socket frame with at least one strut that has an elongated configuration and is connected to a distal base. Additionally, the socket features a suspension system configured as a lanyard-based lock mechanism, which secures a prosthetic liner to the prosthetic socket. The suspension system comprises a lanyard with a first end secured to a quick-release mechanism for interfacing with the prosthetic liner, and a second end attached to a handle linked to a first strut of the socket frame at a rotational axis.

[0016] In one embodiment, the lanyard is arranged in a pulley configuration, with the suspension system containing multiple loops between the first strut and the handle. This setup extends the first end of the lanyard toward the proximal end when the handle is rotated about the rotational axis, moving away from the first strut.

[0017] In another aspect, a prosthetic socket is provided that features a suspension system configured as a string lock mechanism to secure a prosthetic liner to the prosthetic socket. The suspension system includes a lace network with a first end attached to a quick-release mechanism that interfaces with the prosthetic liner, and a second end connected to a lever attached to the first strut of the socket frame at a rotational axis. The lace is arranged in a pulley configuration, with the suspension system containing multiple loops positioned within the first strut to enhance the displaceable length of the first end of the lace toward the proximal end of the prosthetic socket when the lever is rotated away from the first strut.

[0018] In another aspect, a prosthetic socket is provided with a tensioning system that includes a tension mechanism coupled to at least one cable extending between a first terminal and a second terminal, where the first terminal is situated at the tension mechanism and the second terminal is connected to a displaceable lever of the at least one strut. The tensioning system allows for major and minor adjustments of the circumferential cable tension around the prosthetic socket.

[0019] These and other features, aspects, and advantages of the present disclosure will be better understood in the following description, appended claims, and accompanying drawings.

[0020] BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The drawing figures are not necessarily drawn to scale but instead are drawn to provide a better understanding of the components thereof. They are not intended to limit scope but to provide exemplary illustrations. The figures illustrate exemplary configurations of [X] and do not limit the structures or configurations according to the present disclosure.

[0022] FIG. 1A is a frontal elevational view of the posterior side of the adjustable prosthetic socket.

[0023] FIG. IB is a frontal elevational view of an anterior side of the adjustable prosthetic socket of FIG. 1 A without the fabric sleeve.

[0024] FIG. 1C is a cross-sectional view of the distal base taken along lines 1C-1C in FIG. IB.

[0025] FIGS. 1D-1E are frontal elevational views of anterior and posterior sides of the adjustable prosthetic socket with respect to cable guides arranged for routing the cables as observed in FIG. 13B.

[0026] FIG. 2A is an elevational view showing the medial side of the adjustable prosthetic socket of FIG. 1A.

[0027] FIG. 2B is a perspective view of the lock mechanism observed in FIG. 2A.

[0028] FIG. 2C is an elevational view showing an alternative embodiment of the medial side of the adjustable prosthetic socket.

[0029] FIG. 3A is an elevational view showing the lateral side of the adjustable prosthetic socket of FIG. 1A.

[0030] FIG. 3B is an elevational view showing an alternative embodiment of the lateral side of the adjustable prosthetic socket.

[0031] FIG. 4 A is a perspective view of the posterior side of an embodiment of the distal base in the prosthetic socket.

[0032] FIG. 4B is a perspective view of the posterior side of an alternative embodiment of the distal base.

[0033] FIG. 4C is a cross-sectional view of the distal base taken along lines 4C-4C in FIG. IB.

[0034] FIG. 4D is a cross-sectional view of an alternative embodiment of the distal base in FIG. 4C.

[0035] FIGS. 4E-4F are cross-sectional views of the distal base including a mechanism for compensating displacement of the lanyard.

[0036] FIGS. 4G-4H are perspective views of the mechanism in FIGS. 4D-4E.

[0037] FIG. 5A is an exemplary view of a suspension system for the prosthetic socket.

[0038] FIG. 5B is a perspective view of the suspension system in FIG. 5 A.

[0039] FIG. 5C is a perspective view of an alternative embodiment of the suspension system having a fixed axis arrangement.

[0040] FIGS. 5D-5E are cross-sectional views of the suspension system in FIG. 5C.

[0041] FIGS. 5F-5G are perspective views of the suspension system in FIG. 5C in opened positions.

[0042] FIG. 5H is a cross-section view of an alternative embodiment of the suspension system having a sliding axis arrangement.

[0043] FIGS. 5I-5K are perspective views of the suspension system in FIG. 5H in opened positions.

[0044] FIG. 5L is a perspective view of an alternative embodiment of the suspension system.

[0045] FIG. 5M is a sectional view of the side button from the suspension system in FIG. 5L.

[0046] FIGS. 6A-6C illustrate perspective views of a lever for a suspension system in closed, partially open, and fully open positions.

[0047] FIG. 6D is a partial sectional view showing the lateral side of a suspension system in the prosthetic socket.

[0048] FIG. 6E is a cross-sectional view of the suspension system taken along lines 6E-6E in FIG. 6D.

[0049] FIGS. 7A-7B illustrate perspective views of the tensioning system of the socket.

[0050] FIG. 8A illustrates a perspective view of a tension mechanism in the prosthetic socket.

[0051] FIG. 8B is a cross-sectional view of the tension mechanism taken along lines 8B-8B in FIG. 8A.

[0052] FIG. 8C is a perspective view of the tension mechanism in FIG. 8A.

[0053] FIG. 8D is an elevational view of the tension mechanism in FIG. 8D.

[0054] FIGS. 8E-8G are perspective views of an alternative embodiment of the tension mechanism.

[0055] FIGS. 8H-8I are perspective views of an alternative embodiment of the tension mechanism.

[0056] FIGS. 8J-8K are perspective views of an alternative embodiment of the tension mechanism.

[0057] FIG. 9 is a frontal elevational view of an anterior side of the adjustable prosthetic socket with a post-tension mechanism.

[0058] FIG. 10A illustrates a cross-sectional view of an alternative tension mechanism of the adjustable prosthetic socket with a pull strap.

[0059] FIG. 10B illustrates a perspective view of the tension mechanism with the pull strap in FIG. 10B.

[0060] FIG. 10C illustrates a perspective view of the spool and corresponding housing.

[0061] FIG. 11A illustrates a perspective view of an alternative tension mechanism integrated with the adjustable prosthetic socket.

[0062] FIG. 11B illustrates a perspective view of the worm-gear assembly for the tension mechanism in FIG. 11 A.

[0063] FIG. 11C illustrates a cross-sectional view of the spool and housing for the tension mechanism in FIG. 11 A.

[0064] FIG. 12A illustrates a schematic of an alternative tension mechanism in the prosthetic socket having a polygon lock configuration.

[0065] FIG. 12B illustrates perspective and cross-sectional views of the tension mechanism of FIG. 12A integrated with the prosthetic socket.

[0066] FIG. 12C illustrates a cross-sectional view of the tension mechanism of FIG. 12A.

[0067] FIG. 13 A illustrates a schematic of multiple lace tension mechanisms for routing cables in the prosthetic socket.

[0068] FIG. 13B illustrates a schematic of multiple lace tensioning mechanisms of an alternative embodiment for routing cables in the prosthetic socket.

[0069] FIG. 14 illustrates an alternative schematic of lace tension having coterminal arrangements in multiple tension mechanisms.

[0070] FIG. 15 A illustrates an embodiment of telescoping push buttons in the prosthetic socket.

[0071] FIG. 15B illustrates a perspective view of the telescoping push buttons along an extension of a strut.

[0072] FIG. 16 illustrates a perspective view of a sleeve in the prosthetic socket of FIG. 1A having a telescoping fabric configuration.

[0073] FIG. 17A illustrates a cross-sectional view of an elastic region stretched at different lengths.

[0074] FIG. 17B illustrates cross-sectional and perspective views of an embodiment of the sleeve with a fabric covering the elastic region.|0075 | FIGS. 18A-18B illustrate perspective medial and lateral views of the adjustable prosthetic socket having exterior snap-on frame components.

[0076] FIGS. 18C-18E illustrate perspective views of an external sleeve for the prosthetic socket.

[0077] FIG. 19 is a perspective view of a strut of the prosthetic socket having snap-fastener components.

[0078] FIGS. 20A-20B are perspective views of an external sleeve for the prosthetic socket with zones of variable stretchability.

[0079] FIGS. 21A-21B are perspective views of a distal end of the prosthetic socket having a distal attachment.

[0080] FIGS. 21C-21D illustrate an embodiment of the clip and the external sleeve.

[0081] FIGS. 21E-21F illustrate a clamp of the distal base for securing the external sleeve to the socket.

[0082] FIGS. 22A-22B are cross-sectional and perspective views of a distal end of the prosthetic socket having a fit verification mechanism.

[0083] FIGS. 23A-23B are cross-sectional and perspective views of an alternative embodiment of the fit verification mechanism.

[0084] FIGS. 24A-24C are cross-sectional and perspective views of an adjustment mechanism for the tensioning system.

[0085] FIGS. 25A-25C are perspective views of an alternative embodiment of the adjustment mechanism for the tensioning system.

[0086] DEFINITIONS

[0087] The following terms are described to further understand the embodiments of an adjustable socket system as disclosed herein. For explanatory purposes, each embodiment or component described herein may be divided into sections denoted by general anatomical terms for the human body. Such anatomical terms are provided to distinguish various elements of the device embodiments from one another but are not to be considered to limit the scope of the disclosure.

[0088] As used herein, the term "proximal" has its ordinary meaning and refers to a location closer to the heart than another. Likewise, the term "distal" has its ordinary meaning and refers to a location that is further from the heart than another location. The term "posterior" also has its ordinary meaning and refers to a location behind or the rear of another location. The term "anterior" has its ordinary meaning and refers to a location that is ahead of or to the front of another location.

[0089] The terms "inwardly" or "inner" are commonly used herein to distinguish the side of the device that may be directed to the posterior side of the device and specifically adjacent to the residual limb of the wearer of the device or directed to the central axis of the residual limb. Contrariwise, the term "outwardly" or "outer" is used to denote the side of the device that is opposite to the inward side.

[0090] The terms "medial" and "lateral" are relative terms that indicate location concerning the midsagittal plane or midline. Therefore, elements located near the midline are referred to as "medial," and those further from the midline are "lateral." The term "central" denotes the area along the midline of a joint, thereby dividing and sharing regions of the medial and lateral regions.

[0091] The terms “substantial” or “substantially” mean, at minimum, a figure or degree greater than 50 percent up to 99.9 percent. The term “general” means broad or broadly based, whereas “generally” means mostly or closely related and also means that the property or attribute would be readily recognizable by a person of ordinary skill but without requiring a high degree of approximation (e.g., within + / -20% for quantifiable properties).

[0092] The terms "rigid,” "flexible," and "resilient" may be used herein to distinguish characteristics of portions of certain features of the prosthetic system. The term "rigid" denotes that an element of the device lacks flexibility. On the other hand, the term "flexible" is intendedto denote that features are capable of repeated bending. The features may be bent into retained shapes or do not retain a general shape but continuously deform when force is applied. The term "resilient" qualifies as flexible features that return to an initial general shape without permanent deformation. The term "semi-rigid" is used to connote members' properties that provide support and are free-standing; however, such members may have flexibility or resiliency. The term “stretch” means being made or capable of being made longer or wider without tearing.

[0093] The term "cable," as used herein, means cable, lace, string, wire, or similar. The cable may be an elongated wire-like element made of uniform material or arranged as a strand.

[0094] The term "fastener" refers to any suitable connecting or tightening mechanism or structure expressly including, but not limited to, rivets, screws, bolts, and the combinations of bolts and nuts (e.g., without limitation, lock nuts) and bolts, washers, and nuts.

[0095] The term "strut" means a rigid, semi-rigid, elongated structural element forming part of a framework and designed to resist compression.

[0096] The term “textile” is non-limiting and is an umbrella term intended to include various fiber-based materials, including fibers, yarns, filaments, threads, and different fabric types (which may be knit, woven, or non-woven, in various examples). The term “textile” may be used interchangeably with the term “fabric” herein. Examples of suitable, but non-limiting, textiles and other materials for components of disclosed prosthetic devices are provided throughout this disclosure, though those of ordinary skill in the art will appreciate that a variety of textiles and / or other materials may be used to accomplish the technical effects described herein.

[0097] It will be understood that unless a term is expressly defined in this application to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning.

[0098] Any element in a claim that does not explicitly state "means for" performing a specified function or "step for" performing a specific function is not to be interpreted as a "means" or "step" clause as specified in 35 U.S.C. § 112(f).

[0099] DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

[0100] A better understanding of different embodiments of the disclosure may be had from the following description, which is read with the accompanying drawings in which reference characters refer to like elements.

[0101] While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings and are described below. It should be understood, however, that there is no intention to limit the disclosure to the specific embodiments disclosed, but on the contrary, the intention covers all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure.

[0102] In observing FIGS. 1A-1C, a prosthetic socket 100, is adapted to adjust to a residual limb. Therefore, it is considered an "adjustable socket" compared to a rigid socket with a predetermined size and configuration, conventionally known in the art of prosthetic devices. The disclosed prosthetic socket 100 has improved the function and appearance of the structural elements needed for an adjustable socket, including a distal end with a more circular crosssection. It has no bulky bolts / knobs / or protruding features. Advantageously, because of the more streamlined profile, no bulky protruding features are observed when clothing is worn over the socket. Moreover, the disclosed prosthetic socket 100 features an improved suspension system 125 for interfacing with a liner and an improved tensioning system 150 for intuitively assisting the wearer in making adjustments to tighten or loosen the socket.

[0103] The prosthetic socket 100 includes a socket frame 102 with at least one strut 108, 110 with an elongated configuration, and a distal end connected to a distal base 104. The prosthetic socket 100 defines the central axis A- A extending between proximal and distal ends P, D of the prosthetic socket 100, and about which at least one strut 108, 110 is arranged to pivot relative thereto. At least one strut 108, 110 includes a first strut 108 generally extending on a medial side M of the axis A- A and a second strut 110 generally extending on a lateral side L of the axis A-A.

[0104] The first strut 108 includes a medial piece or shell 112 adjustably connected to a proximal end of the first strut 108. The medial piece 1 12 defines at least one wing 117, and more specifically, opposing wings extending laterally relative to the first strut 108. The at least one wing 117 of the medial piece 112 may be flexible or semi-flexible relative to the first strut 108. The first strut 108 is substantially or entirely rigid. The at least one wing 117 has a peripheral shape that tapers away or reduces in height relative to the first strut 108.

[0105] The medial piece 112 defines at least one push button 113 to enable slidable attachment to the proximal end (e.g., extension 155) of the first strut 108 by a channel (not shown) and is configured and dimensioned to a cross-section of the first strut 108. The medial piece 112 is adapted by the at least one push button 113 to adjust in height Hl relative to the first strut 108. Similarly, the second strut 1 10 includes a lateral piece or shell 114 adjustably connected to aproximal end of the second strut 110. In an embodiment, the lateral piece 114 includes at least one push button 115 to enable slidable attachment to the proximal end (e.g., extension 154) of the second strut 110 by a channel (not shown). The lateral piece 114 may be adapted by the at least one push button 115 to adjust in height H2 relative to the second strut 110.

[0106] A textile-based sleeve 116 formed at least one fabric panel assembly of fabric panels 118 is configured to form a circumferential and generally conical enclosure for receiving a residual limb. The sleeve 116 is secured to the socket frame 102 yet can be individually sized relative to the socket frame 102 and is arranged to secure the limb about a central axis A- of the prosthetic and within the socket frame 102. The socket frame is configured to maintain rigidity relative to the sleeve 116. In an embodiment, the sleeve 116 comprises an elastic material, i.e., a stretchable fabric, configured to conform to both the anatomy of the user and functional aspects of the socket 100, such as the socket frame 102 supporting the residual limb. The sleeve 116 can also include areas with greater elasticity, e.g., relatively compared to the distal and proximal fabric panels 118a, 118b. In an embodiment, the distal and proximal fabric subpanels are inelastic.101071 The sleeve 1 16 is arranged to provide an intimate fit to the residual limb and can accommodate a variety of individually sized and configured residual limbs. The fabric sleeve 116 may be configured and formed according to any principles disclosed in U.S. patent no. 10,966,851 and U.S. provisional application no. 63 / 490,075. Portions of the first and second fabric panels 118a, 118b may be inelastic and elastic, depending on the location relative to the socket frame 102, suspension system 125, and / or tensioning system 150. In an embodiment, which will be described later in detail concerning FIG. 16, the sleeve 116 is arranged as a telescoping fabric assembly.

[0108] As explained below, the prosthetic socket 100 has an improved suspension system 125 and an enhanced tensioning system 150. In an embodiment, the suspension system 125 is configured as a hybrid lock (e.g., lanyard-based lock mechanism 126) and is integrated with the medial first strut 108. The tensioning system 150 is advantageously arranged on the lateral second strut 110, which generally allows for greater space than the first strut 108 to house multiple tension mechanisms (e.g., tension mechanism 152). Arranging the suspension system 125 on the medial first strut 108 and the tensioning system 150 on the lateral second strut 110 allows for the first strut 108, which often comes into contact with the sound leg / groin area, to include a low profile to avoid additional thickness and bulk provided by tension mechanisms. The suspension system 125 and tensioning system 150 are integrated in an alternativeembodiment. In other words, the suspension system 125 and tensioning system 150 are provided on the same strut and function using the same handle or lever.

[0109] The at least one tensioning system (e.g., tensioning system 150) is coupled to at least one cable 124 extending between the first and second struts 108, 110 and about or through the sleeve 116. The tensioning system 150 and at least one cable 124 may be arranged similarly as in any of the embodiments of U.S. patent nos. 8,795,385, 9,050,202, and 10,940,028. To better route the at least one cable 124 about the socket frame 102 and the fabric sleeve 116, at least one strut 108, 110 may define at least one cable passageway 1 19 extending through a width of the strut.

[0110] Further, the sleeve 116, and more appropriately, either of the first and second fabric panels 118, includes at least one cable guide 120, 122. The at least one cable guide 120, 122 may be formed by guides formed or stitched to the fabric panels, or a separately formed cable guide, defined as a plate, such as an elongate plate in FIG. IB, secured to or embedded within the at least one fabric panel assembly. The at least one cable guide 120, 122 defines at least one aperture 121 to a channel 123 through which the at least one cable 124 routes or extends. [01111 FIGS. ID- IE illustrate additional views of the prosthetic socket 100 wherein the cable guides 120, 122 are provided with one or more channels 123 to route the at least one cable 124 and provide a pully effect that generates increased displacement when operated by the tensioning system 150. The one or more channels 123 may be linear and / or arcuate to guide the one or more cables 124 between the cable guides 120, 122 and the strut 110. The arrangement of the cable paths is described and illustrated in greater detail with respect to FIG.13B.

[0112] FIGS. 2A-2B illustrate a suspension system 125 for the prosthetic socket 100 having a lanyard-based lock mechanism 126. The lock mechanism 126 is adapted to secure a prosthetic liner 101 to the prosthetic socket 100 and includes a lanyard 132 (or strap) having a first end secured to a quick release mechanism (e.g., quick release mechanism 127) to interface with the prosthetic liner (e.g., liner 101) and a second end secured to a handle 128 attached to a first strut 108 of the socket frame 102 at a rotational axis Rl-Rl. The handle 128 is pivotally secured to the first strut 108 by a spindle member 138 along the rotational axis Rl-Rl to allow for displacement of the handle 128 about the spindle member 138. Displacement of the handle 128 away from the first strut 108 of the socket frame 102 and about the spindle member 138 releases tension along the lanyard 132 to loosen surface contact of the prosthetic socket 100 against the prosthetic liner. The handle 128 includes at least one reel 136, of which lanyard 132 is attached. In an embodiment, the reel 136 is rotatable about an axis parallel to the rotational axis Rl-Rl.

[0113] In an embodiment, the lock mechanism 126 includes a button 130 to lock and unlock the handle 128 against the first strut 108. The handle 128 includes an opening 131 through which the button 130 extends when the handle 128 is locked against the first strut 108. In an embodiment, the button 130 may be configured as a switch, knob, or other low-profile mechanism to mechanically couple and release the handle 128 to and from the strut 108. In an embodiment, the suspension system 125 includes an adjustment guide 134 formed on an exterior distal surface of the first strut 108 to adjust the length of the lanyard 132 fixedly. The suspension system 125 simplifies the distal end for the prosthetic socket 100 and advantageously does not require a pin lock having a large protruding button, cogwheel, sleeve, and multiple bearings. Using the suspension system 125 improves the ease of donning for amputees.

[0114] FIG. 2C illustrates a medial side view of the suspension system 125 having an alternative lock mechanism 141. The lock mechanism 141 will be described in greater detail below with respect to FIGS. 5C-5G. To negate the need to detach the handle 128 from the strut 108 when doffing (i.e., to allow large strap or lanyard displacement) and then to re-attach the handle 128 to the strut 108 when donning, the lock mechanism 141 is advantageously provided with a fixed axis for the handle 128. This simplifies operations for the user, and the size and length of the handle 128 can be increased to provide easier manipulation and torque for donning and doffing.

[0115] FIG. 3A illustrates the tensioning system 150 for the prosthetic socket 100 having one or more tensioning mechanisms 151, 152, which will be described later in detail with respect to FIGS. 8A-14. The tensioning system 150 is operated by a lever 142, which is rotatable about a rotational axis R2-R2 (e.g., by a pivot pin 144), and cable network (e.g., cable 124) to engage (and disengage) the liner against (and away from) the prosthetic socket 100. The lever 142 may include a gripping member 146 to use while locking and unlocking the lever 142 against the frame 102.

[0116] The tensioning system 150, as noted above, includes one or more tension mechanisms (e.g., tension mechanism 152) to adjust the cable 124 tension against and about the sleeve 116 of the prosthetic socket 100. In an embodiment, the cable 124 may extend between a first tension mechanism 152 located on a lateral piece 114 and a second tension mechanism 153, which is more distally located along the second strut 110. As noted above, the lateral piece 114 may be adjusted along a proximal extension 154 of the second strut 110 to accommodate a user’s physiological dimensions.

[0117] FIG. 3B also illustrates the tensioning system 150, wherein the lateral piece 114 is further provided with one or more push buttons 115 for displacing the lateral piece 114 relative to the strut 110. Additionally, the tensioning system 150 is provided with an engagement member 166 to lock and unlock the lever 142 against the strut 110. The distal base 104 may also be configured to receive and attach an external sleeve to the prosthetic socket 100 e.g., to cover functional aspects of the prosthetic socket 100. Such an external sleeve will be described in greater detail with respect to FIGS. 16-21B.

[0118] FIGS. 4A-4C illustrate aspects of the distal base 104. FIG. 4A illustrates the distal base 104 with first and second struts 108, 110 having an angular configuration, wherein each strut 108, 110, and in particular a main middle profile of the strut, substantially forms an angle with the central axis A-A between 20 - 40 degrees. The angular configuration in FIG. 4A accommodates users having a more conical residual limb. FIG. 4B illustrates the distal base 104 with first and second struts 108, 110 having a vertical configuration, wherein each strut 108, 110 is substantially parallel to the central axis A-A. The vertical configuration in FIG. 4B accommodates users having a less conical residual limb.|0119| FIG. 4C illustrates various elements of the distal base 104. The distal base 104 is connected to an adapter 106 in an embodiment. At least one screw 156 extends through at least one hole 157 of the distal base 104 to secure the adaptor 106 to the distal base 104. In an embodiment, a screw 156 (or similar fastening member) is arranged to clamp each strut between the adaptor 106 and funnel 105. Other types of adaptors 106 may be employed to adapt the prosthetic socket 100 to another prosthetic device. Advantageously, the distal base 104 does not require bulky, laterally protruding members and, features a naturally strong circular cross-section, and is more anatomical / human-like.

[0120] FIG. 4D illustrates an alternative embodiment of the distal base 104 wherein the angular position of the strut 108 is fixed e.g., relative to the central axis A-A. As observed, the base of the strut 108 extends and overlaps with the opposing strut 110 between the funnel 105 and adaptor 106. The opposing strut 110 can then be adjusted relative to the fixed strut 108 and distal base 104. Advantageously, the lanyard 132 for the lock mechanism 126 (e.g., see FIGS. 5A-5B) is prevented from inadvertent changes in length.

[0121] By fixing the medial strut 108 at the distal base 104, the configuration of the strut 108 counteracts the high tension imposed by the lanyard 132 of the lock mechanism 126 that would otherwise bias and pull the strut 108 into a (e.g., default maximum) conical position. Fixing the strut 108 simplifies the construction of the socket 100 and improves CPO usability. One skilled in the art will recognize that the lateral strut 1 10 could instead by fixed and overlap withthe medial strut 108 between the funnel 105 and adaptor 106. It is also possible that both struts 108, 110 are angularly fixed relative to the distal base 104.

[0122] In an embodiment of the prosthetic socket 100, the angular position of the struts 108, 110 can be changed with respect to the distal base 104. When the angular position of the struts 108, 110 is modified, e.g., between positions observed in FIGS. 4A and 4B, tension in the lanyard is accordingly adjusted and lengthwise displaced (e.g., by approximately 15mm). To avoid inadvertent displacement of the lanyard 132, the distal base 104 can be provided with a CAM mechanism 195 for displacement compensation. As observed in FIGS. 4E-4H, the CAM mechanism 195 includes a limiter 199 to limit the length of the lanyard 132 depending on angular strut adjustment. The limiter 199 slides within a groove 197 of the strut 108 to extend or shorten length of the lanyard 132. Correspondingly, the length Y of the lanyard 132 between the limiter 199 and a post 191 of the strut 108 varies based on the displacement.

[0123] In FIGS. 4E and 4G, the struts 108, 110 are arranged in a vertical configuration, wherein the limiter 199 causes maximum displacement compensation to the lanyard 132. In FIGS. 4F and 4G, the struts 108, 110 are arranged in an angular configuration, wherein the limiter 199 causes minimum displacement compensation to the lanyard 132. Accordingly, the CAM mechanism 195 cancels out or negates inadvertent / unwanted displacement of the lanyard 132 caused by changing the strut configurations.

[0124] Suspension System

[0125] As noted above, the present disclosure relates to a suspension system for securing a liner to a prosthetic socket. FIGS. 5A-5B illustrate an embodiment of the suspension system 125 for the prosthetic socket 100 with the lock mechanism 126 having a pulley configuration. The lanyard-based lock mechanism 126 is adapted to secure a prosthetic liner 101 to the prosthetic socket 100 and includes a lanyard 132 having a first end secured to a quick-release mechanism 127 to interface with the prosthetic liner (e.g., liner 101) and a second end secured to a handle 128 attached to a first strut 108 of the socket frame 102 at a rotational axis Rl-Rl. The handle 128 is pivotally secured to the first strut 108 by a spindle member 138 along the rotational axis Rl-Rl to allow for displacement of the handle 128 about the spindle member 138.

[0126] In an embodiment, the lanyard 132 is provided in a pulley configuration with the suspension system 125 having multiple loops between the first strut 108 and the handle 128 to extend the first end of the lanyard 132 toward the proximal end P of the prosthetic socket 100 when the handle 128 is rotated about the rotational axis Rl-Rl and away from the first strut 108. The pulley arrangement of the lanyard 132 allows sufficient displacement of the lanyard132 and the corresponding quick-release mechanism 127. The quick-release mechanism 127 may be of the type described in U.S. application no. 17 / 890,748.

[0127] Displacement of the handle 128 away from the first strut 108 of the socket frame 102 and about the spindle member 138 releases tension along the lanyard 132 to loosen surface contact of the prosthetic socket 100 against the prosthetic liner 101. The displacement lets the user attach the quick-release mechanism 127 to the liner 101. In other words, without sufficient displacement (provided by the loops) of the lanyard 132, the user must attach the quick-release mechanism 127 to the liner 101 at an inconvenient, interior distal end of the prosthetic socket 100. Such manipulation at the interior distal end of the prosthetic socket 100 makes it difficult to successfully connect the liner 101 to the quick-release mechanism 127.

[0128] In an embodiment, the handle 128 includes at least one reel 135, 136 about which the lanyard 132 is attached. The reel 135, 136 can be rotatable about an axis parallel to the rotational axis Rl-Rl to reduce frictional forces of the lanyard 132 against the reel 135, 136. The socket frame 102 may include one or more reels 137, 139 about which the lanyard is attached to create loops between reels 135, 136, 137. In an embodiment, the handle 128 includes a compression spring 129 (or similar compressive member) disposed along an inner surface of the handle 128 to aid in displacement of the handle 128 away from the first strut 108 when the handle 128 is unlocked by the button 130. The compression spring 129 may include a cosmetic cover or cap to conceal components of the compression spring 129 from direct exposure.

[0129] FIGS. 5C-5G illustrate an embodiment of the suspension system 125 for the prosthetic socket 100 with a lock mechanism 141 having a fixed axis at the spindle 138 of the handle 128. The lock mechanism 141 is adapted to secure a prosthetic liner 101 to the prosthetic socket 100. Advantageously, to negate the need to detach the handle 128 from the strut 108 when doffing (i.e., to allow large strap or lanyard displacement) and then to re-attach the handle 128 to the strut 108 when donning, the lock mechanism 141 is provided with a fixed axis at the spindle 138 for the handle 128. This simplifies operations for the user, and the size and length of the handle 128 can be increased to provide easier manipulation and torque for donning and doffing. Additionally, the release button 130 is provided at a distal end of the handle 128. In an embodiment, the socket 100 is a prefabricated / off-the-shelf socket wherein the location of the lock mechanism 141 is predefined and integrated with the strut 108.

[0130] The lock mechanism 141 is provided with one or more reels 135, 136 integrated with the handle 128 and one or more reels 137, 139 integrated with the strut 108. As depicted in FIGS. 5F-5G, three loops of the lanyard 132 are provided between the reels 135, 136, 137, 139;however, one skilled in the art will recognize that the number of loops can vary depending on desired displacement and friction provided by the lanyard 132, wherein the greater number of loops increases friction and force required to close the handle 128 against the strut 108.

[0131] FIGS. 5H-5K illustrate an embodiment of the suspension system 125 for the prosthetic socket 100 with a lock mechanism 143 having a sliding axis at the spindle 138 of the handle 128. To simplify the step of attaching a quick release mechanism 127 to the liner 101, the lock mechanism 143 provides increased displacement for the quick release mechanism 127 and lanyard 132 in the proximal direction. In other words, the displacement of the lanyard 132 should be large enough so that the quick-release mechanism 127 can be pulled near the proximal end of the socket 100, and the increased displacement of the lanyard 132 makes donning and doffing easier. To increase the level of displacement for the lanyard 132, the handle 128 is provided with a sliding axis at the spindle 138. The spindle 138 slides along the length of the strut 108 within a slot 147 formed in the strut 108. Again, the level of displacement and friction provided by the lanyard 132 can vary based on the number of loops of the lanyard between reels 135, 136, 137, 139 of the handle 128 and strut 108.101321 FIGS. 5L-5M illustrate an embodiment of the suspension system 125 for the prosthetic socket 100 with a lock mechanism 141 having a fixed axis at the spindle 138 of the handle 128 and also having a button 130 arranged on the posterior and / or anterior side of the strut 108. Advantageously, a distance between the spindle 138 and the proximal-most reel 136 is maximized by arranging the button 130 on the side of the strut 108 to provide greater displacement of the lanyard 132. The reel 135 is integrated with the strut 108 and arranged to receive a recess 149 formed in the handle 128. In an embodiment, actuation of the button 130 (e.g., via spring or other elastic component) displaces the reel 135 from the recess 149 to unlock the handle 128 from the strut 108. One skilled in the art that other actuation means can be implemented to lock and unlock the handle 128 to and from the strut 108 to operate the suspension system 125 of the socket 100.

[0133] FIGS. 6A-6C illustrate the suspension system 125 having a string lock mechanism 140 integrated with at least one strut (e.g., second strut 110). The string lock mechanism 140 is operated by the handle 128, which is rotatable about the first rotational axis Rl-Rl, and lace network to engage (and disengage) the liner against (and away from) the prosthetic socket 100. In an embodiment, the handle 128 is rotatable about the rotational axis Rl-Rl, e.g., by a protruding member 145. In an alternative embodiment, the handle 128 is rotatable about the rotational axis Rl-Rl by a spindle member 138 (see FIG. 3A). Other types of pivoting members may be used to permit rotation of the handle 128 about the rotational axis Rl-Rl.

[0134] FIG. 6A shows the string lock mechanism 140 in a closed configuration against the second strut 110. The low profile offered by the string lock mechanism 140 allows for easier donning and doffing of clothing and prevents tearing or snagging against the material. FIG. 6B shows the handle 128 in a partially open position, and FIG. 6C shows the handle 128 substantially (or fully) open. The handle 128 is connected to a sliding member 158 by one or more links 160. The links 160 provide a rigid connection between the handle 128and the sliding member 158. The sliding member 158 is arranged within a cavity 162 of the second strut 110 and configured to translate along an inner profile 163 of the second strut. The sliding member 158 may be confined to translation along one or more grooves 164 or tracks to enable smooth translation.

[0135] In an embodiment, the handle 128 includes an engagement member 166 to lock and unlock the handle 128 against the second strut 110. The engagement member 166 (similar to the button 130) may click into place when the handle 128is fully closed, and the engagement member 166 may be pushed to release the handle 128from against the second strut 110.

[0136] FIGS. 6D-6E illustrate the network lace 168 as part of the string lock mechanism 140. The string lock mechanism 140 is adapted to secure a prosthetic liner 101 to the prosthetic socket 100 and includes the lace 168, having a first end secured to a quick-release mechanism 174 to interface with the prosthetic liner 101 and a second end connected to the handle 128 attached to a second strut 110 of the socket frame 102 at a rotational axis Rl-Rl. The lace 168 is provided in a pulley configuration (i.e., network) with the suspension system 125 having multiple loops disposed within the second strut 110 to increase a displaceable length L of the first end of the lace 168 toward the proximal end P of the prosthetic socket 100 when the handle 128 is rotated about the rotational axis Rl-Rl and away from the second strut 110. The multiple loops of lace 168 disposed within the second strut 110 extend through multiple conduits 170 formed within the second strut 110. The lace 168 extends between a quick release mechanism 174 and terminal 172; the terminal 172 is located at the sliding member 158 through a distal duct 176 of the socket frame 102 and a funnel 105 secured to the distal base 104.

[0137] Displacement of the handle 128 away from the second strut 110 of the socket frame 102 releases tension along the lace 168 to loosen surface contact of the prosthetic socket 100 against the prosthetic liner 101. The displacement lets the user attach the quick-release mechanism 174 (or similar connection means) to the liner 101. In other words, without sufficient displacement (provided by the loops) of the lace 168, the user must attach the quick-release mechanism 174 to the liner 101 at an inconvenient, interior distal end of the prosthetic socket 100.Advantageously, the string lock mechanism 140 removes the seal requirement for the prosthetic socket 100.

[0138] The suspension system 125 simplifies the distal end for the prosthetic socket 100 and advantageously does not require a pin lock having a large protruding button, cogwheel, sleeve, and multiple bearings. The approach using the suspension system 125 improves the ease of donning for amputees. Further, the principles of the lock mechanisms 126, 141 and the string lock mechanism 140 apply to each other and can be employed or integrated into the suspension system 125.

[0139] Tensioning System

[0140] The present disclosure further relates to a tensioning system for the prosthetic socket to adjust the circumferential tension of one or more cables about the prosthetic socket. In the first aspect, the tensioning system includes one or more tension mechanisms coupled to at least one cable extending between a first terminal and a second terminal; the first terminal is located at the tension mechanism, and the second terminal is connected to a displaceable lever of at least one strut. The tension mechanism is suitable for adjusting cable length (minor tension adjustments) and is used in conjunction with other methods (e.g., handle or lever) to tension the socket (major tension adjustments) due to the significant force required to do so.

[0141] The tensioning mechanisms function to adjust the socket initial sizing of the socket to the individual user. Because the disclosed socket can be “off-the-shelf,” the socket is configured to accommodate a range of different residual limbs. The amount of lace displacement provided by the tensioning mechanisms depends on the number of types (i.e., sizes, lengths) provided. In certain embodiments, the tension mechanism can provide up to 50cm of displacement, up to 40cm of displacement, up to 30cm of displacement, up to 20cm of displacement, or up to 10cm of displacement; however, the level of maximum displacement provided by each tensioning mechanism depends on the size of the residual limb of the user and the number of individual tensioning mechanisms provided with the socket.

[0142] The tensioning mechanisms also function to allow users to make minor adjustments to the internal volume of the socket, e.g., both day-to-day and potentially year to year. This sort of adjustment is done by the user multiple times is day (depending on amount of volume change). For example, volume fluctuations of the residual limb in the short term (e.g., hourly, daily, weekly) can occur from shrinking or swelling of the limb due to a variety of factors, including increased / decreased temperature, increased / decreased activity, and weight loss / gain.

[0143] To make the socket more comfortable to the user, the tensioning mechanisms allow the user to make minor adjustments to the tension provided by the at least one cable and accountfor such volume fluctuations. The tensioning mechanisms allow for continuous adjustment of the socket. If the user needs to make a huge adjustment (e.g., significant weight loss or weight gain that could require a new liner), major displacement by the tensioning mechanisms (like that which can occur during initial sizing) may be required to accommodate the user.

[0144] The tensioning system allows for major and minor adjustments of the circumferential cable tension around the prosthetic socket. Actuation of the lever is for donning and doffing of the socket by the user. The lever of the present disclosure advantageously provides sufficient torque for proper displacement of the at least one cable. Closing of the lever, e.g., during donning, is configured to compresses the socket against the liner and / or residual limb of the user. The actuation of the lever (i.e., switching the lever between open and closed positions) is configured to displace the at least one cable and provides 3cm to 30cm of displacement, preferably 10cm to 25cm of displacement, and, more preferably, approximately 20cm of displacement. The level of displacement is dependent on the size of the residual limb of the amputee; however, excessive displacement of the at least one cable (e.g., 100cm) can create issues for the user and become tangled up.|0145 | As readily apparent within the present disclosure, the lever of the tensioning system is arranged to adjust circumferential tension for donning and doffing the socket, whereas the one or more tensioning mechanisms (e.g., with knobs) are arranged to fine-tune the level of circumferential tension of the socket, i.e., at specific or local regions, and provide a more individualized, anatomical fit against a residual limb. The tensioning mechanism provides an analog functionality to the socket by allowing continuous adjustment of the at least one cable. Because the tensioning mechanism includes a spool about which the cable is wound, the tensioning mechanism functions as an analog dial to make adjustments and account for volume fluctuations within a given range, similar to a dimmer switch for lights or an analog clock. In contrast, the lever of the tensioning system provides a discrete function (i.e., switched open or closed) for easy donning and doffing of the socket.

[0146] In an embodiment, actuation of the lever concurrently adjusts the sleeve in size for donning and doffing of the socket, the lever being configured to displace the at least one cable and further configured to compress the socket against the residual limb during donning. In an embodiment, the actuation of the lever generally produces greater displacement of the at least one cable for circumferential adjustment of the socket than a full rotation of the spool of the at least one tension mechanism. As noted above, the term “generally” means that the property or attribute would be readily recognizable by a person of ordinary skill but without requiring ahigh degree of approximation (e.g., within + / -20% for quantifiable properties), i.e., more often than not.

[0147] In an embodiment, the handle or lever is first used to un-tension the socket to permit cable length adjustment, and then the handle or lever is used to tension the socket again. The advantage of the disclosed approach (as opposed to the existing system employing tensioning dials, for example, which adjust lace length and apply tension) is that donning and doffing the socket is simplified to using just one handle (or lever), which is either locked or unlocked. Existing dial-based systems require many turns to tension, and each time they are tensioned, the amputee may or may not be tightening to a preferred tensioning value / feeling.

[0148] Although all the designs of the disclosed tension system allow the user to self-adjust lace length, it may be that, in some cases, the amputee does not have the cognitive ability or confidence to self-adjust. In this case, the certified professional may be provided with means to prevent lace adjustment by the amputee, for example: incorporating a removable ‘key’ component of the tensioning system, such as a handle or knob; introducing a cover or guard over the aspect the amputee would use to lace adjust; and / or tightening a screw or lock the tensioning system using a tool.

[0149] FIGS. 7A-7B illustrate an embodiment of the tensioning system 150 of the prosthetic socket 100 comprising a lever 142 for actuating circumferential displacement of the socket 100 about a liner 101. At least one cable 124 of the tensioning system 150 is connected to a distal end 133 of the lever 142, wherein the at least one cable 124 is further connected to one or more tensioning mechanisms 151, 152 and one or more cable guides 120, 122, as observed in Figs. 3 A. Rotation of the lever 142 about the rotational axis R2-R2 from a closed position (observed in FIG. 7A) to an open position (observed in FIG. 7B) displaces the cable 124 from the distal end of the socket 100 toward a proximal end. Displacement of the cable 124 away from the second strut 110 of the socket frame 102 releases tension along the cable 124 and threads the cable 124 through one or more eyelets 148 of the strut 110 to loosen surface contact of the prosthetic socket 100 against the prosthetic liner 101.

[0150] The embodiment of the tensioning system 150 in FIGS. 7A-7B offers convenient displacement of the cable 124 and reduces both the need for complex cable paths and the amount of friction in the tensioning system 150. In an embodiment, the cable 124 exposed along the outer surface of the strut 110 can be covered in a flexible cosmetic material (e.g., kitted or weaved structure or plastic tube) to reduce a risk of snagging or breaking of the cable 124.

[0151] FIGS. 8A-8D illustrates an embodiment of the tensioning system 150 having a ‘push- to-release’ tension mechanism 152. In an embodiment, the tension mechanism 152 includes a spool 178 about which the at least one cable 124 is wound. The cable 124 is arranged to be wound about a barrel 182 of the spool and between an upper flange 186 and a lower flange 188. In an embodiment, the spool 178 is housed within a cavity 189 of the socket frame 102 and includes a set of teeth 194 to mesh with an inner surface 185 of the socket frame 102. In an embodiment, the spool 178 is biased against the inner surface 185 of the socket frame 102 by a spring member 190, which is positioned within an annulus 184 of the spool 178.

[0152] The spool 178 includes a flap 180 having a tab 183, the flap 180 being pivotable at a radial joint 181 arranged to manipulate the spool 178 to at least displace the teeth 194 of the spool 178 toward the inner surface 185 and rotate the spool 178 to either increase or decrease the tension of the at least one cable 124. The teeth 194 are arranged on the upper flange 186, while the lower flange 188 is configured to freely rotate about a track 192 formed along an inner surface 185 of the socket frame 102. Advantageously, the flap 180 may be rotated approximately 90° to allow the user to turn the tension mechanism more easily 152. The flap 180 further discourages accidental dial pushing to prevent accidental loosening of the cable 124.

[0153] FIGS. 8E-8G illustrate an alternative tension mechanism 151 for the tensioning system150. The tension mechanism 151 includes a spool or spool body 165 having a drive 159 arranged to receive an external tool, such as a screwdriver or a hex key, so that a user and / or healthcare professional can adjust the tension of the at least one cable 124 applied by the tension mechanism 151. The body is further provided with an aperture 161, arranged to receive a fastener (e.g., a screw) for securing an anchor 167 to the body 165. The anchor 167 covers the drive 159, which is to be used for objective adjustment by a healthcare professional.

[0154] The body 165 is further provided with a recess 173 configured to receive a lid 169. The lid 169 is connected to the body 165 to allow manual adjustment of the tensioning mechanism151. A user may flip or rotate the lid 169 relative to the body 165, i.e., the lid 169 pivots within the recess 173 and with respect to the body 165, to a perpendicular position that provides a greater surface area for the user to manipulate the tension mechanism 151 via the lid 169. The lid 169 is connected to the body 165, wherein the cavity (e.g., cavity 189) housing the tension mechanism 151 (e.g., formed within the frame 102) prevents the tension mechanism 151 from sliding out of the body 165. Thus, the tension mechanism 151 allows both user adjustments and objective healthcare professional adjustments.

[0155] FIGS. 8H-8I illustrate a simplified tension mechanism 179 without a drive and anchor. In an embodiment, the lid 171 is directly connected to the body 165, wherein the cavity (e.g., cavity 189) housing the tension mechanism 179 (e.g., formed within the frame 102) prevents the tension mechanism 179 from sliding out of the recess 175. In FIGS. 8J-8K, the body 165 of the tension mechanism 179 is provided with an arched slot 177 arranged to receive an arched profile 187 of the lid 171. The arched slot 177 and profile 187 allow controlled pivoting of the lid 171 with respect to the body 165.

[0156] FIGS. 9 illustrates an embodiment of the tensioning system 150 as a post-tension mechanism 200. The mechanism 200 includes a first post 196 as part of a minor tensioning region 202 and a second post 198 as part of a major tensioning region 204. The cable 124 can be wrapped around the first post 196 and guided through a first slot 206 to allow for small adjustments. The cable can be wrapped around the second post 198 and guided through a second slot 208 to allow for larger adjustments. In an embodiment, the first slot 206 is a slightly tight region to prevent the cable 124 from falling off the post 196. In an embodiment, the posts 196 and 198 are provided on a cable guide 120.[0157| FIGS. 10A-10C illustrates an embodiment of the tensioning system 150 having a ‘pull- to-release’ tension mechanism 209. The tension mechanism 209 includes a spool 178 about which the at least one cable 124 is wound, the spool 178 being housed within the socket frame 102 (or housing 211) and including a set of teeth 216 to mesh with an inner surface 185 of the socket frame 102. The spool 178 is biased against the inner surface 185 of the housing 211 by a spring member 214. The tension mechanism 209 further includes a pull strap 210 for manipulating the spool 178 to at least displace the teeth 216 away from the inner surface 185, which consequently draws in or out the cable 124 through an opening 218 on the socket frame 102. The inner surface 185 may be part of base 220 arranged to interface with the teeth 216. Advantageously, the ‘pull-to-release’ tension mechanism 209 prevents accidental displacement of the spool 178 by inadvertent contact or compression against the tension mechanism 209.

[0158] FIGS. 11 A-l 1C illustrate an embodiment of the tensioning system 150 having a wormgear assembly tension mechanism 222. The tension mechanism 222 allows the amputee to selfadjust the length of the cable (e.g., cable 124). After an adjustment has been made, the additional step of locking the tension mechanism 222 is not required due to the friction / relationship between screw and gear. The tension mechanism 222 may be covered by a cap 224.

[0159] The tension mechanism 222 comprises a spool 178 having radial teeth 236. The spool 178 is housed within the socket frame 102 (or housing 228) and further includes a worm screw230 having a rotational shaft 226 and rotor member 234 adjacent to the radial teeth 236 of the spool 178. The tension mechanism 222 further comprises a guard 232 to prevent the cable 124 from becoming trapped between the radial teeth 236 and the worm screw 230. In an embodiment, the tension mechanism 222 is used with a stepper motor, which is not required to hold the torque constantly and can be powered off for most of the day.

[0160] FIG. 12A-12C illustrate an embodiment of the tensioning system 150 having a polygon lock tension mechanism 237. The polygon lock 237 includes a polygon profile 238 formed circumferentially about the spool 178 and a contoured pocket 240 formed within a chamber 239 of the socket frame 102 for housing the tension mechanism 237. As depicted, the spool 178 is locked in position when the polygon profile 238 engages with the contoured pocket 240. The spool is held in (or released from) the locked position depending on the tension provided by the cable 124. The chamber 239 includes an arcuate surface 241 against which the polygon profile 238 is free to rotate to increase or decrease the tension of at least one cable 124. In an embodiment, as depicted in FIG. 12B, the spool 178 may further comprise an integrated flap 242 to assist in manipulating the spool 178 within the contoured pocket 240. In an embodiment, as depicted in FIG. 12C, the polygon lock 237 may be provided with a cap 244 to manipulate the spool 178 within the contoured pocket 240.

[0161] FIGS. 13A-14 illustrate schematics of the tensioning system 150, including multiple tension mechanisms (e.g., tension mechanism 152) at rotatable terminals 246, 248, 250, 252, cables 247, 249, 251, 253, and a main displacement terminal 254. The first cable 247 is routed between a first rotating terminal 246 and a lever 142, which is provided with the prosthetic socket 100 that opens and closes in the frontal plane using a button 256 extending through an opening 257. This allows the lever 142 to be neatly / cosmetically integrated into the strut and simultaneously displace the cables 247, 249, 251, 253 with the sliding member 158 at the main displacement terminal 254.

[0162] FIG. 13A illustrates the first cable 247, located between the first terminal 248, at the tension mechanism 152, and the main displacement terminal 254, at the sliding member 158. The first cable 247 is arranged to extend through at least one cable guide (e.g., cable guide 122) and the socket frame 102. Similarly, the disclosed schematic provides for larger cable displacement and allows the socket to open wider, thus making donning / doffing easier.

[0163] FIG. 13B, having the posterior cables 251, 253 removed for clarity, illustrates routing of the anterior cables 247, 249. The first cable 247 is routed between the first rotating terminal 246 (e.g., tension mechanism) and the lever 142 . In particular, the first cable 247 is threaded from the terminal 246, through a distal cable guide 122 and through a lateral distal cable guide259, and routed 180° over one or more reels to the main displacement terminal 254. The second cable 249 is threaded from the terminal 248, through a proximal cable guide 120 and through both the strut 110 and the lateral piece 114, to the main displacement terminal 254. The arrangement in FIG. 13B offers greater cable displacement in the tensioning system 150 by providing less friction, larger radii, simpler paths, and better force distribution over the socket and residual limb.

[0164] FIG. 14 illustrates an embodiment wherein first and second terminals 246, 248 are provided at the same tension mechanism 152, and third and fourth terminals 250, 252 are provided at another tension mechanism 153. A first main displacement terminal 254 is provided for the second and fourth cables 249, 253 (i.e., left-side cables) and a second main displacement terminal 255 is provided for the first and third cables 247, 251 (i.e., right-side cables). The arrangement in FIG. 14 permits a simplified tightening scheme to tighten the top or the bottom.

[0165] Telescoping Mechanism and Attachments

[0166] FIGS. 15A-15B illustrate a telescoping mechanism 260 for the medial piece 112, which can likewise be employed for the lateral piece 114. In an embodiment, push buttons 113a, 113b are provided at the medial piece 112 to permit height adjustment. The push buttons 113a, 113b are provided with indentations 263 and configured to engage with teeth 262 formed along rails 261 of the extension 155 of the strut 108. The push buttons are biased using an extension spring 258 to bias the indentations 263 against the teeth 262. In an embodiment, more than one push button 113a, 113b is provided as a safety feature to prevent accidental release.

[0167] FIG. 16 illustrates an exemplary and non-limiting configuration of the sleeve 116. The sleeve 116 comprises a distal fabric panel 118a, a proximal fabric panel 118b, and an elastic region 264 connecting the distal and proximal fabric panels 118a, 118b. The elastic region 264 has greater elasticity than the distal and proximal fabric panels 118a, 118b, so the distal and proximal fabric subpanels are preferably inelastic.

[0168] In embodiments where the prosthetic socket 100 includes telescoping mechanisms or is otherwise adjustable in height, both the strut components and fabric components need to telescope. FIG. 17A illustrates an embodiment wherein the elastic region 264 is arranged underneath a non-stretch layer 265. The non-stretch layer 265 is attached to the fabric panel 118 by a connector 266 or stitching (or other fastening means). Even when the elastic region 264 is stretched from a minimum length of LI to a maximum length of L2, the non-stretch layer 265 underneath prevents bulging. This approach permits telescoping without negatively affecting socket volume / fit. FIG. 17B illustrates an alternative embodiment wherein anadditional covering 268 (e.g., stitches, material) is arranged on the outside of the sleeve 116 to prevent excessive stump protrusion.

[0169] It is preferred to have an external sleeve (i.e., sock) over the functional aspects of the prosthetic socket. Ideally, the user can remove the external sleeve and put it in the washing machine. This is not possible for the functional textiles which are structural / weight bearing, and as such would pose too great a risk to ask the amputee to remove these parts and put them in the washing machine. Additionally, the external sleeve improves aesthetic appeal and allows for readily customizable appearances. For example, users can replace external sleeves depending on the activity or occasion, i.e., a thicker sleeve may be provided for cooler weather, or a certain color or pattern may be preferred when hunting or dining.

[0170] FIGS. 18A-18E illustrate an embodiment of the prosthetic socket having attachable frame components for attaching an external sleeve 300. As observed in FIGS. 18A-18B, the struts 108, 110 and pieces 112, 114 are provided with exterior casings 302, 304, 306, 308 that are configured to snap onto respective areas of the frame 102. The exterior casings 302, 304, 306, 308 are connected to the external sleeve 300, wherein attachment between fabric of the external sleeve 300 and the exterior casings 302, 304, 306, 308 provided by an adhesive, overmolding, sewing, or mechanical means. Reference to external sleeve 300 can apply to the sleeve 116.

[0171] FIG. 18C illustrates a medial portion 310 of the external sleeve 300 having an opening 314 to access the handle 128 of the suspension system 125. FIG. 18D illustrates a lateral portion 312 of the external sleeve 300 having an opening 318 to access the lever 142 of the tensioning system 150 and one or more openings 316 to access one or more tension mechanisms (e.g., tension mechanism 179). The sleeve 300 is configured to adjust in size during actuation of the lever 142 for donning and doffing of the prosthetic socket 100, the lever 142 being configured to displace the at least one cable 124 and further configured to compress the prosthetic socket 100 against the residual limb during donning of the prosthetic socket 100 by the user. FIG. 18E illustrates the lateral portion 312 attached to the exterior casing 304 and having at least one opening 316.

[0172] FIG. 19 illustrates a perspective view of the strut 108 having integrated attachment points 320 (e.g., snap fasteners or buttons). For example, one aspect of a snap fastener may be located on the external sleeve 300 and another aspect of the snap fastener may be located on the frame 102. Alternative attachment points 320 could include magnets, hook-and-loop materials, and the like.

[0173] FIGS. 20A-20B illustrate perspective views of the external sleeve 300 having variable stretch zones. In particular, thin zones 326, 328 of the external sleeve 300 are fixed to corresponding parts of the frame 102, whereas stretch zones 322, 324 of the external sleeve 300 are provided between struts 108, 110 and proximal pieces 112, 114, respectively, to allow for adjustments in heights Hl, H2.

[0174] FIGS. 21A-21B illustrate a distal base 104 having a distal attachment for the external sleeve 300. To attach the external sleeve 300 to the distal base 104 of the socket 100, one or more C-shaped clips 330 can be used. The external sleeve 300 is fixed (i.e., glued or adhered) to the clip 330, which deforms sufficiently so that the external sleeve 300 can be pulled over a large prosthetic knee, e.g., a powered knee. The clip 330 is sufficiently rigid that once clipped in place within a channel 334 of the distal base 104, the clip 330 does not dislocate from the distal base 104 without user intent, i.e., with proper force. In an alternative embodiment, a drawstring is provided with the external sleeve 300, wherein the drawstring is arranged to encircle the channel 334 of the distal base 104.

[0175] FIGS. 21C-21D illustrate an embodiment of the clip 330 and the external sleeve 300. The external sleeve 300, e.g., the medial portion 310 and / or the lateral portion 312, includes a pocket 332 to receive the clip 330. FIG. 21D illustrates the external sleeve 300 having the clip 330 inserted within the pocket 332.

[0176] FIGS. 21E-21F illustrate the distal base 104 of the socket 100 having a clamp 336 arranged to secure the external sleeve 300 to the socket 100. In an embodiment, the one or more clips 330 are secured at the distal base 104 between the clamp 336 and the funnel 105. The clamp 336 can be secured to the funnel 105 by one or more fasteners 338 (e.g., screws, bolts). In an embodiment, the clamp 336 is configured as multipart clamp to enable assembly and simplify manufacturing.

[0177] The clip 330 can also be of different geometries, e.g., a circular clip that extends between both medial and lateral portions 310, 312. In an embodiment, more than two clips 330 are provided, e.g., a first clip 330a and a second clip 330b. Advantageously, the arrangement of the clip 330 within the one or more pockets 332 of the external sleeve 300 being secured at the distal base 104 by the clamp 336 prevents unintended detachment of the external sleeve 300 from the socket 100. The clamp 336 can be secured to external sleeve 300 at the distal base 104 using one or more of the following, e.g., press fit mechanism, adhesive connection, and / or threaded or screw attachment.

[0178] FIGS. 22A-23B illustrate the distal base 104 comprising a verification mechanism 400 for verifying proper fit and placement of the liner 101 with respect to the prosthetic socket 100.For a good prosthetic socket fit, congruence is needed between the distal end of the liner 101 and the distal end of the socket 100. In other words, it is preferred for the distal end of the liner 101 to be in contact with the distal base 104 of the prosthetic socket 100. However, as the socket 100 is closed, it is difficult for the user to observe the interior positioning of the liner 101 within the socket 100. Advantageously, the verification mechanism 400 allows users to readily observe that the liner 101 is in contact with the bottom of the socket 100.

[0179] As observed in FIGS. 22A-22B, the verification mechanism 400 is provided with an indicator 406, which is actuated by a spring 402 and post 408 housed within the distal base 104. When the liner 101 and liner pin 411 enter the distal base 104 of the socket 100, the indicator 406 is pushed in the radial direction, away from the central axis A-A. When the indicator 406 is engaged by the liner pin 411 of the liner 101, the indicator 406 protrudes from the socket 100. This protrusion can be seen, felt with the fingertips, or even heard.

[0180] In an embodiment, indicator 406 is colored or has a different color from the socket 100 and / or distal base 104 to provide easier visual recognition of the proper fit. FIGS. 23A-23B illustrate an alternative verification mechanism 500, wherein the indicator 506 is actuated by a spring 502 and post 508 and also by direct contact with the liner 101 (or umbrella of the liner 101).

[0181] FIGS. 24A-24C illustrate a global adjustment mechanism 600 for quickly adjusting the general tension of the tensioning system 150 for the prosthetic socket 100. When engaged in sports or demanding physical activities, the general socket tension should be greater. And when a user wants to relax at home for the day, the general tension in the prosthetic socket 100 can be loosened to provide extra comfort. However, there are certain instances when a user may need to quickly do and doff the socket 100, but does not want to spend extra time by putting on both the liner 101 and the socket 100. One way to address this is to bypass donning of the liner 101 and to quickly configure the socket 100 to fit tight enough to quickly take care of a limited, local task. In other words, the adjustment mechanism 600 is arranged to compensate for liner-less applications by providing supplemental tightening of the socket 100 to more closely engage with the residual limb.

[0182] The adjustment mechanism 600 comprises a button 602 configured to shift along one or more channels 606, 608 to adjust the tension provided by the one or more cables 247, 249, 251, 253. The cables are wrapped around one or more posts 624, 626 of the button 602. The button 602 is biased against the strut 110 by a spring 604, which is housed within the strut 110. The button 602 comprises a set of teeth 612 to interlock with a corresponding set of teeth 610of the strut 110 to incrementally displace the button 602 in the proximal and distal directions and along the channels 606, 608.

[0183] FIGS. 25A-25C illustrate an alternative global adjustment mechanism 700 that adjusts the effective point in which the links 160 connect to the lever 142. Similar to the aforementioned button 602, the adjustment mechanism 700 is provided with a button 706 that is arranged to adjust attachments points 708, 710 of the links 160 to the lever 142. This in turn effects the amount of cable displacement the lever 142 creates when closed.

[0184] It is understood that not all objects or advantages may be achieved under any embodiment of the disclosure. Those skilled in the art will recognize that suspension and tensioning systems may be embodied or carried out to achieve or optimize one advantage or group of advantages as taught herein without achieving other objects or advantages as taught or suggested herein.

[0185] The skilled artisan will recognize the interchangeability of various disclosed features. Besides the variations described herein, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to build and use prosthetic sockets under the principles of the present disclosure. The skilled artisan will understand that the features described herein may be adapted to other methods, types of devices, and applications.

[0186] It is intended that the present disclosure should not be limited by the disclosed embodiments described above and may be extended to other applications that may employ the features described herein.

Claims

CLAIMS1. A prosthetic socket (100) adapted to adjustably fit to a residual limb, the prosthetic socket (100) defines an axis (A- A) extending centrally between proximal and distal ends (P, D) of the prosthetic socket (100), the prosthetic socket (100) comprising: a socket frame (102) including at least one strut (108, 110) having an elongate configuration and having a distal end connected to a distal base (104); a textile-based sleeve (116, 300) connected to the socket frame (102) and forming an enclosure for receiving the residual limb; and a tensioning system (150) arranged for circumferential adjustment of the prosthetic socket (100), the tensioning system (150) including at least one cable (124) coupled to a lever (142) and at least one tension mechanism (151, 152, 179, 209, 222) having a spool (165, 178) about which the at least one cable (124) is wound, wherein the lever (142) is displaceable from the at least one strut (110); wherein the socket frame (102) is configured to maintain rigidity relative to the sleeve (116, 300); and wherein the sleeve (116, 300) is configured to adjust in size during actuation of the lever (142) for donning and doffing of the prosthetic socket (100), the lever (142) being configured to displace the at least one cable (124) and further configured to compress the prosthetic socket (100) against the residual limb during donning of the prosthetic socket (100).

2. The prosthetic socket (100) of claim 1, wherein the spool (165, 178) is housed within the socket frame (102) and includes a set of teeth (194, 216) to mesh with an inner surface (185) of the socket frame 102.

3. The prosthetic socket (100) of claim 2, wherein the spool (165, 178) is biased against the inner surface (185) of the socket frame 102 by a spring member (190).

4. The prosthetic socket (100) of claim 2, wherein the spool (178) includes a flap (180), pivotable at a radial joint (181), for manipulating the spool (178) to at least displace the teeth (194) of the spool (178) toward the inner surface (185) and rotate the spool (178) to either increase or decrease tension of the at least one cable (124).

5. The prosthetic socket (100) of claim 2, wherein the at least one tension mechanism (209) includes a pull strap (210) for manipulating the spool (178) to at least displace the teeth (216) of the spool (178) away from the inner surface (185).

6. The prosthetic socket (100) of claim 1, wherein the tension mechanism (222) includes a worm-gear assembly (222).

7. The prosthetic socket (100) of claim 6, wherein the worm-gear assembly comprises the spool (178) having radial teeth (236) and being housed within the socket frame 102 and further comprises a worm screw (230) having a rotor member (234) adjacent to the radial teeth (236) of the spool (178).

8. The prosthetic socket (100) of claim 7, wherein the worm-gear assembly further comprises a guard (232) to prevent the at least one cable (124) from becoming trapped between the radial teeth (236) and the worm screw (230).

9. The prosthetic socket (100) of claim 1, wherein the at least one tension mechanism (152) includes a polygon lock (237) as part of a spool (178) about which the at least one cable (124).

10. The prosthetic socket (100) of claim 9, wherein the polygon lock (237) includes a polygon profile (238) formed circumferentially about the spool (178) and a contoured pocket (240) formed within a chamber (239) of the socket frame (102) for housing the tension mechanism (237).1 1. The prosthetic socket (100) of claim 10, wherein the spool (178) is locked in position when the polygon profile (238) engages with the contoured pocket (240).

12. The prosthetic socket (100) of claim 10, wherein the chamber (239) includes an arcuate surface (241) against which the polygon profile (238) is free to rotate for either increasing or decreasing tension of the at least one cable (124).

13. The prosthetic socket (100) of claim 1, further comprising a suspension system (125) having a lock mechanism (126, 140, 141) including a handle (128) and a quick-release mechanism (127, 174) to attach and detach the prosthetic socket (100) to a prosthetic liner (101).

14. The prosthetic socket (100) of claim 13, wherein the handle (128) is connected to the quickrelease mechanism by a lanyard (132) looped around at least one reel (135, 136) integrated with the handle (128).

15. The prosthetic socket (100) of claim 14, wherein displacement of the handle (128) away from the at least one strut (108) of the socket frame (102) releases tension along the lanyard (132) to loosen surface contact of the prosthetic socket (100) against the prosthetic liner (101).

16. The prosthetic socket (100) of claim 1, further comprising a sleeve (116) secured to the distal base (104) by a clamp (336) and having at least one fabric panel assembly (118) configured to form a circumferential and a generally conical enclosure for receiving a residual limb, the at least one fabric panel assembly (118) securing to the socket frame (102).

17. The prosthetic socket (100) of claim 16, at least one cable guide (120, 122) configured to receive the at least one cable (124) and disposed within the sleeve (116).

18. The prosthetic socket (100) of claim 1, wherein a first strut (108) of the at least one strut is angularly fixed relative to the distal base (104) and overlaps a second strut (110) at the distal base (104).

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