WO2025193894A1

WO2025193894A1 - Seal system for use with a prosthetic socket

Info

Publication number: WO2025193894A1
Application number: PCT/US2025/019685
Authority: WO
Inventors: Hronn KRISTINSDOTTIR; Oskar Thor LARUSSON; Stefan Orn Stefansson
Original assignee: Ossur Iceland ehf; Ossur Americas Inc
Current assignee: Ossur Iceland ehf; Ossur Americas Inc
Priority date: 2024-03-13
Filing date: 2025-03-13
Publication date: 2025-09-18
Anticipated expiration: 2026-09-13

Abstract

Seal systems (100) and prosthetic socket and seal system assemblies (152) are configured for interfacing a residual limb donned with a prosthetic suspension liner with a prosthetic socket (154). The suspension of the residual limb within the prosthetic socket (154) may be achieved by creating a hypobaric pressure chamber between the residual limb and the distal end (172) of the prosthetic socket (154). The seal system (100) comprises of a socket ring (102) attached to the inner surface (156) of the prosthetic socket (154) and a seal component (120) that is configured for removable attachment to the socket ring (102). The socket ring (102) and seal component (120) are configured to frictionally engage the residual limb and form a seal between the residual limb and the prosthetic socket (154) to ensure the suspension of the residual limb.

Description

SEAL SYSTEM FOR USE WITH A PROSTHETIC SOCKET

[0001] FIELD OF DISCLOSURE

[0002] The disclosure relates to prosthetic sockets and liners and, more particularly, to a prosthetic socket having a seal or a seal system.

[0003] BACKGROUND

[0004] In some existing prosthetic systems, such as vacuum-type suspension systems, prosthetic liners help secure a residual limb within a prosthetic socket by creating a close-fitting relationship that isolates the distal end area of the socket from the atmosphere. A prosthetic socket is typically a custom-made sleeve that connects a residual limb to a prosthesis, also known as an interface. The socket provides a weight-bearing surface, support while walking, and control of other prosthetic components. A prosthetic or suspension liner provides a soft, flexible interface between a residual limb of an amputee and a hard socket to which a prosthetic device is secured.

[0005] When a pulling force is applied to the prosthetic liner in relation to the socket, suction is generated at the isolated distal end of the socket, which helps retain the prosthetic liner inside it. Suitable devices are typically provided to facilitate the expulsion of air between the liner’s distal end and the prosthetic socket, as well as to keep the distal end of the prosthetic socket member isolated from the atmosphere after the prosthetic liner with a residual limb is fully inserted into the socket.

[0006] It may be beneficial to more effectively secure the prosthetic liner within the socket by creating a hypobaric (vacuum) pressure at the distal end of the prosthetic socket in the space defined between this distal end and the distal end of a prosthetic liner that is inserted into the socket with a residual limb contained within the liner. The hypobaric pressure can be maintained at the distal end of the prosthetic socket, and the interior of the socket at this end will remain isolated from the atmosphere while the sleeve liner is normally retained within the socket. Opening the distal end of the socket to the atmosphere releases the vacuum or hypobaric pressure, allowing for simple and easy withdrawal of a residual limb with the prosthetic liner from the socket. A pump or other device may be used to evacuate the space between the distal end of the prosthetic liner and the distal end of the socket. A valve or other appropriate mechanism typically opens and closes the distal end of the socket to the external atmosphere.

[0007] Various arrangements exist in certain current prosthetic systems to provide a seal between the exterior of the prosthetic liner and the interior of the prosthetic socket. This seal functions to define a suspension chamber within the socket, which is separated from atmospheric pressure, including a separate and movable seal that can be positioned on the exterior of the prosthetic liner. These movable seals allow users to selectively adjust the position of the movable seal on the liner to a preferred longitudinal location, thereby avoiding sensitive or compromised tissue. They may also assist users who experience volume changes throughout the day in maintaining suspension.

[00081 However, a disadvantage of these movable seals is their tendency to migrate unintentionally, either circumferentially or longitudinally, between the prosthetic liner and the prosthetic socket during use. This movement can lead to the potential failure of the suspension of the residual limb and relative movement between the liner and socket, which reduces user comfort and heightens the risk of friction-related injuries such as blisters and skin irritation. Additionally, movable seals often overcompensate for unwanted movement by being overly large or difficult to adjust, making it challenging for users to effectively don and doff the movable seal. Overcompensated seals can create pressure points on the residual limb, further diminishing comfort.

|0009| Attached seal liners can be challenging to invert for older adults or individuals with hand dexterity issues. Movable seals may include a separate seal ring requiring an additional donning step, increasing complexity. In some liner systems, a seal pin is utilized, necessitating careful positioning during donning, which could be difficult for users with limited dexterity. Accordingly, there is a need for a seal system with an improved seal component that allows for stable positioning of the seal component relative to the prosthetic socket and the prosthetic liner while maintaining effective suspension of a residual limb within the socket.

[0010] SUMMARY

[0011] A seal or seal system is disclosed herein to provide an interface between a residual limb and a prosthetic socket that minimizes slippage between the two. The seal or seal system may include a socket ring configured to be attached to the inner surface of a prosthetic socket, with the socket ring featuring a body that has open proximal and distal ends, an inner surface forming an opening throughout, and an outer surface opposite the inner surface.

[0012] The socket ring may have a groove extending outwardly from an aperture on its inner surface, with at least part of the groove widening outwardly from the aperture. The seal system may also have a seal component that can be removable and attached to the inner surface of the socket ring body. This seal component includes a body with open proximal and distal ends, an inner surface defining an opening through it, and an outer surface opposite the inner surface. The seal element may extend radially outward from the outer surface of the seal component body at or near the proximal end, configured to interlock with the groove of the socket ring to create a seal. Additionally, the seal component may have a liner sealing portion on its inner surface that is arranged to engage and seal against the outer surface of a prosthetic liner.

[0013] The seal element of the seal system may extend from the outer surface of the seal component body at a first thickness and then widen outwardly to a second thickness that is greater than the first. Constructed from a hard shore silicone, the seal element allows insertion into the socket ring groove. The socket ring may feature one or more protrusions configured for attachment to the prosthetic socket.

[0014] Prosthetic socket and seal system assemblies can create an interface between a residual limb and a prosthetic socket. This assembly may comprise a prosthetic socket with an inner surface, a prosthetic liner, a socket ring, and a seal component. The socket ring is configured to be secured to the inner surface of the prosthetic socket, comprising a socket ring body with open proximal and distal ends, an inner surface defining an opening through it, and an outer surface opposite the inner surface.

|0015 | The socket ring may feature a groove that extends outward into the socket ring body from an aperture on its inner surface, with at least a portion of the groove widening outward from the aperture. The seal component is arranged for removable attachment to the inner surface of the socket ring body. This seal component includes a seal component body with open proximal and distal ends, with an inner surface defining an opening through it and an outer surface opposite the inner surface. A seal element may extend radially outward from the outer surface of the seal component body near the proximal end, configured to interlock with the socket ring’s groove and create a seal.

[0016] The seal component may also include a liner sealing portion on the inner surface of the seal component body arranged to fictionally engage and seal with the outer surface of a prosthetic liner. The liner sealing portion may comprise one or more flaps configured to form a seal between the seal component and a prosthetic liner disposed over the residual limb.

[0017] The embodiments of the disclosure provide an advantage over liner systems that utilize a pin, as a pin can be detached from the liner. Additionally, the process of donning the liner with the seal component may be more accommodating, requiring less precision from the user because there is no need to align a pin with a lock, as seen in some traditional prosthetic sockets. These and other features, aspects, and advantages of the present disclosure will become clearer in relation to the following description, appended claims, and accompanying drawings. [0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawing figures are not necessarily to scale; rather, they are created to enhance understanding of the components involved and are not meant to limit scope but to serve as illustrative examples. The figures depict exemplary disclosure configurations and do not restrict the structures or configurations according to the present disclosure.

[0020] Fig. 1 is a perspective view of an exemplary prosthetic device, including a prosthetic socket and a prosthetic limb.

[0021] Fig. 2 is a perspective view of an exemplary seal system, comprising a socket ring and a seal component.

[0022] Fig. 3 is a section view of an exemplary socket ring.

[0023] Fig. 4 is a section view of an exemplary seal system.

[0024] Fig. 5 is a section view of an exemplary seal component comprising a liner sealing portion having inwardly extending flaps.

[0025] Fig. 6 is a magnified section view of an exemplary seal component.

[0026] Fig. 7 is a section view of an exemplary seal system.

[0027] Fig. 8 is a perspective view of an exemplary seal component.

[0028] Fig. 9A is a view of another exemplary prosthetic liner.

[0029] Fig. 9B is an exemplary view of variations of a prosthetic liner.

[0030] Fig. 10 is a section view of an exemplary socket ring.

[0031] Fig. 11 is a top view of an exemplary prosthetic socket and seal system assembly.

[0032] Fig. 12 is a top view of an exemplary prosthetic socket and seal system assembly.

[0033] DEFINITIONS

[0034] The term “hard durometer silicone” refers to a silicone having a shore “A” durometer from 60 to 90, or more preferably, a shore “A” durometer from 70 to 80.

[0035] The term “outwardly” refers to a direction away from the residual limb when a user wears the device.

[0036] The term “inwardly” refers to a direction towards the residual limb when the device is worn by a user (i.e., a direction opposite of “outwardly”). [0037] The term “seal” refers to a boundary of the device over which a substantial amount of air is prevented from passing.

[0038] The term “interlock” refers to the configuration of two features that engage each other by overlapping or fitting projections and recesses together.

[0039] DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

[0040] The current disclosure pertains to seal systems and prosthetic socket and seal system assemblies configured to secure a residual limb to a prosthetic socket of a prosthetic device. Suspension of the residual limb can be achieved by creating a hypobaric pressure chamber at the distal end of the prosthetic socket, positioned between the inner surface of the socket and the residual limb. This hypobaric pressure chamber forms when a residual limb is inserted into the socket, with air between the limb and the distal end of the socket being expelled through a valve, such as a one-way valve. A seal system, comprising a socket ring and seal component, is configured to interface between the residual limb and the prosthetic socket. This seal system creates a seal that maintains the hypobaric pressure chamber at the distal end of the socket.

[0041] The seal system is also configured to reliably maintain its position relative to the prosthetic socket, ensuring that the seal remains intact. By minimizing movement between the prosthetic socket and the seal system, the motion between the residual limb and the prosthetic socket may also be reduced. Consequently, the seal system offers the added benefit of decreasing the likelihood of friction-related injuries, such as friction blisters and skin irritation.

[0042] Fig. 1 illustrates an exemplary prosthetic device 10 featuring a prosthetic socket 12 and a prosthetic limb 14 similar to those commonly known in the art. The prosthetic socket 12 is configured to accommodate a user's residual limb 16. A prosthetic liner 18 may be placed over the residual limb 16 to create an interface between the prosthetic socket 12 and the residual limb 16. A hypobaric pressure chamber may form between the prosthetic socket 12 and the residual limb 16 to support the residual limb 16. Fig. 1 also shows a location 20 where a seal system may be effectively positioned to interface between the prosthetic socket 12 and the prosthetic liner 18, thereby securing the residual limb 16 to the prosthetic socket 12.

[0043] The prosthetic liner 18 may be as in any of the liner embodiments according to at least U.S. Pat. No. 4,923,474, granted on May 8, 1990; U.S. Pat. No. 6,796,364, granted on Mar. 16, 2004; U.S. Pat. No. 9,770,891, granted Sep. 26, 2017; U.S. Pat. No. 11,918,492, granted Mar. 5, 2024; each of these patents is incorporated by reference. [0044] Fig. 2 depicts a seal system 100 configured to provide an interface between a residual limb 16 and a prosthetic socket 12. The seal system 100 may include a socket ring 102 intended to be affixed to the inner surface of a prosthetic socket 12. The socket ring 102 comprises a socket ring body 104 with open proximal and distal ends 106, 108, and an inner surface 110 that defines an opening 112 through it, along with an outer surface 114 opposite the inner surface 110. The socket ring body 104 may be constructed from hard plastics such as polyvinyl chloride, polyethylene, polypropylene, or other similar materials. Although the socket ring body 104 may generally have a circular profile, it can also possess other shapes, including elliptical, oval, or rounded configurations, or any shape configured to closely match the circumference of a residual limb 16. The opening 112 of the socket ring body 104 may taper from a wide opening at the proximal end 106 to a narrower opening at the distal end 108 to better align with the tapering profile of the residual limb 16.

[0045] Fig. 3 illustrates a sectional view of the exemplary socket ring 102 from Fig. 2. The socket ring 102 may feature a groove 116 that extends outward into the socket ring body 104 from an aperture 118 located on the inner surface 110 of the socket ring body 104, with the groove 116 including a surface 144 that runs from the aperture 118 to an outward point of the groove 116. The groove 116 preferably spans the entire circumference of the inner surface 110 of the socket ring body 104. From the aperture 118 on the inner surface, the groove 116 may extend outward into the socket ring body 104 so that at least a portion of the groove 116 widens outward from the aperture 118. The surface 144 of the groove 116 may have a wedge-shaped profile, an oblong profile (as seen in Fig. 7), a triangular profile, or any other profile that widens immediately from the aperture 118.

[0046] Fig. 4 shows a sectional view of a seal system 100 featuring the socket ring 102 and a seal component 120 configured to be removably secured to the inner surface 110 of the socket ring body 104. The seal component 120 may include a seal component body 122 with open proximal and distal ends 124, 126, an inner surface 128 that defines an opening 130 through it, and an outer surface 132 opposite the inner surface 128. The seal component 120 may also comprise a seal element 134 that protrudes radially outward from the outer surface 132 of the seal component body 122 at or near the proximal end 124, with the seal element 134 configured to interlock with the groove 116 of the socket ring 102 to form a seal. Figs. 4 and 5 depict a view of the seal system 100, including the seal element 134. Specifically, the seal element 134 may have a first portion 158 that extends outward from the outer surface 132 of the seal component body 122, with the first portion 158 having a first thickness T 1 , and a second portion 160 extending outward from the first portion 158, where the second portion has a second thickness T2 greater than the first thickness Tl.

[0047] The seal element 134 may be positioned within the groove 116 to secure the seal component 120 to the socket ring 102, thereby forming a seal between the seal component 120 and the socket ring 102 that maintains a hypobaric pressure chamber. The second portion 160 may have a thickness greater than the shortest distance across the aperture 118 to prevent the removal of the seal element 134 during normal use of the prosthetic device. The interaction of the first and second portions 158 and 160 of the seal element 134 with the surfaces 144 of the groove 116 and aperture 118 creates a seal and allows the seal component 120 and the socket ring 102 to interlock. The first thickness is preferably similar to the shortest distance DI across the aperture 118. In this way, the seal component 120 may be more strongly secured to the socket ring 102 and form a tighter seal. In some embodiments, the profile of the seal element 134 may closely match the surface 144 of the groove 116, contributing to a tighter seal.

[0048] The seal component 120 may include a liner sealing portion 136 featuring one or more flaps 146 that extend inwardly from the inner surface 128 of the seal component body 122. These flaps 146 can protrude inwardly and run along the circumference of the liner sealing portion 136 and are configured to engage frictionally and form a seal with the outer surface of the prosthetic liner 18. In some variations, the liner sealing portion 136 may comprise one, two, or three flaps 146, or even more than three flaps 146. Upon the insertion of the residual limb 16 through the opening 130 of the seal component body 122, the flaps 146 may bend to lie flat against the surface of the prosthetic liner 18 or the residual limb 16, thereby creating a seal between the prosthetic liner 18 and the seal component 120 to sustain the hypobaric pressure chamber and support the residual limb 16.

[0049] [48] Fig. 7 shows a section view of an exemplary seal system 100. The thickness T5 of the seal component body 122 may taper from proximal to distal, or, as illustrated in Fig. 5, may maintain a uniform thickness in that direction.

[0050] Fig. 8 presents a profile view of the seal component 120, indicating that it has enough flexibility to bend with hand manipulation. The seal component 120 may be made from a material that possesses sufficient rigidity, enabling the seal element 134 to maintain a seal and endure the vacuum of the hypobaric pressure chamber, as well as the frictional forces between the inner surface 128 of the seal component 120 and the residual limb 16. This ensures that the seal element 134 is not inadvertently dislodged from the groove 116 during normal use of the prosthetic device, while still being flexible enough to allow the second portion 160 of the seal element 134 to bend for insertion into the groove 116. Suitable materials include malleable polymers like hard durometer silicone.

[0051] Similar to the seal component shown in Fig. 8, it may be configured as a solid elastomeric sleeve, such as silicone. The seal component would be applied similarly to the previously mentioned seal component in a socket and may feature a low-friction coating. Indeed, in any of the embodiments, the seal component can include a low-friction coating to facilitate donning.

[0052] The seal component 120 may include a liner sealing portion 136 on the inner surface 128 of the seal component body 122, configured to frictionally engage and seal with the outer surface of a prosthetic liner 18. The opening 130 of the seal component body 122 may taper from the proximal end 124 to the distal end 126 to ensure adequate contact between the liner sealing portion and the prosthetic liner 18, allowing for effective frictional engagement with the residual limb 16. For example, the seal component body 122 may possess a conical shape (as shown in Fig. 4).

[0053] A distal end of the outer surface of the prosthetic liner 18 may be devoid of fabric or other textile material, including the area of the prosthetic liner 18 that contacts the sealing component 120, since a fabric or textile surface on the outer surface of the prosthetic liner 18 could negatively affect the ability of the residual limb 16 to pass through the opening 130 of the seal component body 122 when flaps 146 are present on the liner sealing portion. In some embodiments, the entirety of the outer surface of the prosthetic liner 18 may lack any fabric or textile material. The liner sealing portion 136 may also be treated with a low-friction coating to ease the insertion of the residual limb 16 through the opening 130 of the seal component body 122.

[0054] Fig. 9A shows an alternative prosthetic liner 174 featuring a proximal end 176 and a distal end 178, along with a high-friction portion 180 that may engage the liner sealing portion 136 of the seal component body 122. The high-friction portion 180 may comprise materials with a higher friction coefficient than other sections of the prosthetic liner's 174 outer surface. The coefficient of friction of the high-friction portion 180 may be tailored to secure the residual limb 16 to the seal component 120 and create a seal between the prosthetic liner 174 and the seal component 120. For instance, the high-friction portion 180 may include silicone. A prosthetic liner 174 with a high-friction portion 180 may be configured for use, especially in cases where the liner sealing portion 136 of the sealing component 120 lacks inwardly extending flaps 146. The protruding rings or seal bands 181 may be provided alone or in combination with the high-friction portion, and are taught in U.S. Pat. No. 11,918,492.

[0055] Fig. 9B illustrates various possibilities for adapting a prosthetic liner 190 according to the disclosure, which could be utilized with the aforementioned seal system or the seal system defined in U.S. Pat. No. 11,918,492. In the first instance, the distal end may be coated with a wax coating 192. Specifically, wax may be employed to enhance the water-repellent properties of the liner, aiding in the seal against the socket ring and other seals. In another variation, the prosthetic liner 190 may be dipped in silicone to create a distal end featuring a silicone coating, also represented by 192. The silicone coating can provide a smooth, even surface and be used with the removable and socket seals.

[0056] In another variation, a textile cover for the prosthetic liner (not shown but described in the references concerning a prosthetic liner incorporated herein) may include a textile with a low-friction coating. Alternatively, the textile cover may be replaced with a higher durometer silicone than the silicone layer, forming an inner side or periphery of the prosthetic liner. An example of a multiple durometer prosthetic liner can be found in U.S. Pat. No. 6,136,039, granted Oct. 24, 2000, the entirety of which is incorporated herein by reference.

[0057] In another variation, taking the prosthetic liner 174 as an example, the high-friction portion may instead be configured as an uncoated textile or matrix in a designated area. The textile may be arranged so that silicone or another suitable elastomeric material can bleed through and form a solid section extending from the inner side of the prosthetic liner to the outer side.

[0058] In another variation exemplified in Fig. 9B by coating 194, the liner 190 may be sprayed with a silicone coating 194 to reduce friction. Alternatively, in another variation, talcum 196 can be infused into the silicone to decrease friction.

[0059] In some embodiments, the socket ring 102 may include two or more grooves 116 arranged distally to proximally along the inner surface 110 of the socket ring body 104. This arrangement enables the seal component 120 to be positioned more distally or proximally within the prosthetic socket 12, allowing for the selection of the optimal distal-to-proximal position of the seal component to maximize comfort and fit for the residual limb 16. In some instances, the prosthetic device may comprise two or more socket rings 102. The seal component 120 may incorporate two or more seal elements 134 that protrude radially from the outer surface 132 of the seal component body 122, allowing them to be inserted into and interlocked with the grooves 116 of the socket ring 102. This design would help secure the seal component 120 more tightly to the socket ring 102, thereby reducing the likelihood of slippage between the seal component 120 and the prosthetic socket 12 and effectively maintaining a seal between the socket ring 102 and the seal component 120 to preserve the hypobaric pressure chamber.

[0060] Fig. 10 illustrates a sectional view of a socket ring 102 featuring two or more protrusions 148 extending from the outer surface 114 of the socket ring body 104. These protrusions 148 may be arranged to assist in securing the socket ring 102 to the prosthetic socket 12. For example, the protrusions 148 may comprise a first portion 162 extending from the socket ring body 104, with the first portion 162 having a first thickness T3, and a second portion 164 extending from the first portion 162, which has a second thickness T4 greater than the first thickness T3.

[0061] The socket ring 102 may comprise two, three, four, five, six, seven, or eight protrusions 148, or more than eight protrusions 148. The protrusions 148 may be molded into the prosthetic socket wall during the formation of the prosthetic socket 12. In other embodiments, the socket ring 102 may not include any protrusions 148 (as shown in the socket ring 102 illustrated in Fig. 3). In such embodiments, the socket body 104 may be integrated into the wall of the prosthetic socket 12.

[0062] Fig. 11 illustrates an exemplary assembly 152 of a prosthetic socket and seal system, which provides an interface between a residual limb 16 and a prosthetic socket 154. The assembly may include a prosthetic socket 154 with an inner surface 156, a prosthetic liner (such as prosthetic liner 18 or 174), and a socket ring 102 configured to be attached to the inner surface 156 of the prosthetic socket 154. A seal element 134 of a seal component (like seal component 120 described above) may be arranged for removable securing to an inner surface 110 of the socket ring body 104 of the socket ring 102 through insertion into a groove 116.

[0063] In some embodiments, the protrusions 148 may be threaded between the strands of a braided fiber layer used to construct the prosthetic socket 154. This may occur as the prosthetic socket 154 is molded to the residual limb 16. The construction of the prosthetic socket 154 may follow the method described in U.S. Pat. No. 7,438,843, granted on Oct. 21, 2008, and U.S. Pat. No. 5,972,036, granted on Oct. 26, 1999; the entirety of each patent is incorporated herein by reference. For example, while constructing an exemplary prosthetic socket 154, a prosthetic liner may first be placed on the residual limb 16, compressing it into the appropriate shape needed to comfortably fit the prosthetic socket 154. An end cap may be placed over the distal end of the prosthetic liner, followed by an inner protective sheath placed over the prosthetic liner. The inner protective sheath may have an opening to receive a portion of the end cap. The socket ring 102 may then be positioned around the residual limb 16 over the inner protective sheath, ensuring that the inner surface 110 of the socket ring body 104 is flush with the inner surface of the prosthetic socket 154.

[0064] A braided fiber layer (e.g., carbon fiber, glass fiber, or basalt fiber), formed into a generally tubular shape, is placed over the silicone sheet. If present on the socket ring 102, the protrusions 148 of the socket ring 102 may then be threaded through the braid of the braided fiber layer. The braided fiber layer may be sufficiently long to extend distally from the distal end of the residual limb 16, covering at least the same length already surrounding the residual limb 16. In this scenario, the braided fiber layer may be folded proximally back along the residual limb 16 to create a second layer of braided fiber layers.

[0065] The protrusions 148 of the socket ring 102 may be threaded through a second layer of braided fiber. A prosthesis coupler element configured to receive an injected material may be connected to or integrated into the distal end of the braided fiber layers. An outer protective sheath may be placed over the braided fiber layers, creating an enclosed zone with the inner protective sheath containing the braided fiber layers and the socket ring 102.

[0066] A resin may then be extruded through the prosthesis coupler element or injected into the enclosed zone. The resin may be manipulated to permeate the braided fiber layer(s), such that upon curing, the protrusions 148 are fixed within the braided fiber layers and resin of the prosthetic socket wall 166. The resin preferably forms a seal between the socket ring body 104 and the prosthetic socket wall 166 to maintain the hypobaric pressure chamber. The inner and outer protective sheaths may then be removed while finishing the prosthetic socket 154.

[0067] Fig. 12 illustrates another exemplary prosthetic socket and seal system assembly 152, comprising a prosthetic socket 154 with an inner surface 156 and seal system, which includes a socket ring 102 and a seal component 120 (featuring flaps 146 on the inner surface 128 of the seal component body 122 for creating a seal between the residual limb 16 and the prosthetic socket 154), configured to interface between the prosthetic socket 154 and the residual limb 16. Also illustrated are an end cap 168 and a valve 170 (e.g., a one-way valve) configured to form the hypobaric pressure chamber between the residual limb 16 and the distal end 172 of the prosthetic socket 154.

[0068] To don the prosthetic device, the seal component 120 may first be inserted into the prosthetic socket 154, with the seal element (such as seal element 134) of the seal component 120 interlocking with the groove (such as groove 116) of the socket ring 102. The residual limb 16 may then be placed through the opening 130 of the seal component body 122 until friction between the seal component 120 and the residual limb 16 prevents further movement of the residual limb 16 within the prosthetic socket 154, establishing a seal between the residual limb 16 and the liner sealing portion 136 of the seal component 120. As the residual limb 16 descends within the prosthetic socket 154, the air between the prosthetic socket 154 and the residual limb 16 may be pushed through the valve to form the hypobaric pressure chamber, enabling suspension of the residual limb 16.

[0069] It is to be understood that not necessarily all objects or advantages may be achieved under any embodiment of the disclosure. Those skilled in the art will recognize that the disclosed seal systems may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without achieving other objects or advantages as taught or suggested herein.

[0070] 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 devices under principles of the present disclosure. It will be understood by the skilled artisan that the features described herein may be adapted to other methods and types of prosthetic devices or applications.

[0071] 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

1. A seal system (100) for providing an interface between a residual limb (16) and a prosthetic socket (12), the seal system (100) comprising: a socket ring (102) configured to be secured to an inner surface of a prosthetic socket (12), the socket ring (102); and a seal component (120) arranged for removably securing to an inner surface (110) of the socket ring (102).

2. The seal system (100) of claim 1, wherein the socket ring (102) comprises a socket ring body (104) having open proximal and distal ends (106, 108) and an inner surface (110) defining an opening (112) therethrough, and an outer surface (114) opposite the inner surface (HO).

3. The seal system (100) of claim 2, wherein the socket ring (102) further defines a groove (116) extending outwardly into the socket ring body (104) from an aperture (118) on the inner surface (110) of the socket ring body (104), at least a portion of the groove (116) widening outwardly from the aperture (1 18).

4. The seal system (100) of claim 2, wherein the socket ring (102) comprises two or more protrusions (148) extending from the outer surface (114) of the socket ring body (104), the protrusions (148) configured to facilitate securing of the socket ring (102) to the prosthetic socket (12).

5. The seal system (100) of claim 1, wherein the seal component (120) comprises a seal component body (122) having open proximal and distal ends (124, 126) and an inner surface (128) defining an opening (130) therethrough, and an outer surface (132) opposite the inner surface (128).

6. The seal system (100) of claim 3, wherein the seal component (120) comprises a seal element (134) protruding radially outward from the outer surface (132) of the seal component body (122) at or near the proximal end (124), the seal element (134) configured to interlock with the socket ring (102) and form a seal.

7. The seal system (100) of claim 6, wherein a profile of the seal element (134) is shaped to approximate a surface (144) of the socket ring (102).

8. The seal system (100) of claim 7, wherein a thickness of the seal element (134) widens in an outward direction from a first thickness (T3) to a second thickness (T4) greater than the first thickness (T3) and wherein the second thickness (T4) is greater than a shortest distance (DI) across the aperture (118).

9. The seal system (100) of claim 6, wherein a thickness (150) of the seal component body (122) tapers from the proximal end (124) to the distal end (126).

10. The seal system (100) of claim 6, wherein the socket ring (102) further comprises a liner sealing portion (136) on the inner surface (128) of the seal component body (122) arranged to fictionally engage and seal with an outer surface of a prosthetic liner.

11. The seal system (100) of claim 10, wherein the liner sealing portion (136) comprises one or more flaps (146) extending inwardly from the inner surface (128) of the seal component body (122), the flaps (146) configured to frictionally engage and seal with the outer surface of the prosthetic liner.

12. The seal system (100) of claim 6, wherein the seal component (120) comprises two or more seal elements (134) protruding radially outward from the outer surface (132) of the seal component body (122) and wherein the two or more seal elements (134) are configured to interlock with the two or more grooves (116) formed by the socket ring (102), and form a seal between the socket ring (102) and the seal component (120).

13. A prosthetic socket assembly (152) for providing an interface between a residual limb and a prosthetic socket (154), the assembly comprising: a prosthetic socket (154) having an inner surface (156); a prosthetic liner; a socket ring (102) configured to be secured to the inner surface (156) of the prosthetic socket (154), the socket ring (102); a seal component (120) arranged for removably securing to an inner surface (110) of the socket ring body (104), the seal component (120).

14. The prosthetic socket assembly (152) of claim 13, wherein the socket ring (102) includes: a socket ring body (104) having open proximal and distal ends (106, 108) and an inner surface (110) defining an opening (112) therethrough, and an outer surface (114) opposite the inner surface (110); and a groove (116) extending outwardly into the socket ring body (104) from an aperture (118) on the inner surface (110) of the socket ring body (104), at least a portion of the groove (116) widening outwardly from the aperture (118).

15. The prosthetic socket assembly (152) of claim 14, wherein the seal component (120 includes: a seal component body (122) having open proximal and distal ends (124, 126) and an inner surface (128) defining an opening (130) therethrough, and an outer surface (132) opposite the inner surface (128); a seal element (134) protruding radially outward from the outer surface (132) of the seal component body (122) at or near the proximal end (124), the seal element (134) configured to interlock with the groove (116) of the socket ring (102) and form a seal; and a liner sealing portion (136) on the inner surface (128) of the seal component body (122) arranged to fictionally engage and seal with an outer surface of a prosthetic liner.