Patent Application
20130190895
The disclosure relates to the field of prosthetic devices, and more particularly to a sleeve including a reinforcement layer for use with a socket.
In certain applications, an amputee wears a liner over a residual limb as an interface between a definitive socket and the residual limb. The socket is attached to the residual limb and liner by a suspension mechanism. Besides the liner, a sleeve is commonly worn over the socket and liner combination for additional suspension of the prosthetic limb by preventing air from entering or exiting the proximal end of the socket. The sleeve extends distally over the brims of the socket and elastically conforms to the residual limb and socket to form a seal between the socket and the liner.
Because of the desire to produce a tight fluid seal with the liner and socket, the sleeve necessarily closely conforms to the surface contours of the residual limb, liner, and socket. This characteristic of the sleeve results in added stress to areas of the sleeve which come into contact with the brims of the socket. The interior layer of the sleeve is especially susceptible to being deformed by the socket brims.
Over the knee area, the sleeve stretches over the knee. Some sleeves may include a greater thickness around the socket brims. This construction may avoid early wear and tear of the sleeve, but also may create resistance at the knee and add to material costs of and weight of the sleeve. This reduces both comfort and flexibility of the sleeve.
Therefore, there is a need in the prosthetic art to provide sleeves with improved durability while maintaining the comfort and flexibility to adapt to the needs of each user.
The challenges of known prosthetic devices are addressed under embodiments described providing a sleeve having a reinforcement layer. Adding a reinforcement layer or element to the sleeve provides more support to the device in localized areas to strengthen the sleeve against stresses from contact with the brims of a socket. The reinforcement layer allows for better durability and comfort.
Under an embodiment of the device, a tubular sleeve has interior and exterior surfaces, a proximal opening in a proximal area, and a distal area, and is adapted to be worn on a residual limb. The sleeve includes a fabric layer, a polymeric layer, and a reinforcement layer. The fabric layer has interior and exterior surfaces and continuously forms the exterior surface of the sleeve. The polymeric layer is bonded to the fabric layer and forms the interior surface of the sleeve. The reinforcement layer is arranged in a localized area of the sleeve with the localized area being between a proximal area and a distal area of the sleeve.
In an embodiment of the sleeve, the reinforcement layer may extend radially around the entire circumference of the sleeve. The reinforcement layer may have limited or no elasticity in the longitudinal direction of the sleeve. The thickness may generally be consistent across the length of the sleeve, and the reinforcement layer does not impede flexibility or contribute to adding weight to the sleeve.
In another embodiment of the sleeve, the reinforcement layer may extend radially around most of the circumference of the sleeve, and the reinforcement layer may be elastic in the longitudinal direction of the sleeve.
A method involves placing the sleeve over a definitive socket and aligning a localized area of the sleeve with a brim of the socket. The sleeve may have an area of curvature corresponding to the reinforcement layer that accommodates the knee joint.
The sleeve is described referring to the accompanying drawings which show preferred embodiments according to the device described. The sleeve as disclosed in the accompanying drawings is illustrated for example only. The elements and combinations of elements described below and illustrated in the drawings can be arranged and organized differently to result in embodiments still within the spirit and scope of the device described.
A better understanding of different embodiments of the sleeve may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements.
While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings and will be described below. It should be understood, however, 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 and defined by the appended claims.
It will be understood that, unless a term is expressly defined in this disclosure 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.
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, paragraph 6.
The anatomical terms described are not intended to detract from the normal understanding of such terms as readily understood by one of ordinary skill in the art of prosthetics. The term “distal” is used to denote the portion or end of a limb farthest from the central portion of the body. The term distal is the opposite of “proximal” which is used to denote that the end or portion of the limb is nearer to the central portion of the body.
Some components described share similarities to components in U.S. Pat. No. 6,706,364 granted Mar. 16, 2004, incorporated by reference and belonging to the assignee of this disclosure.
The embodiments described may be used with a socket as described in U.S. Pat. No. 6,589,289, granted Jul. 8, 2003 granted Mar. 16, 2004, incorporated by reference and belonging to the assignee of this disclosure.
In an exemplary embodiment of the prosthetic device,
The reinforcement layer is provided at least on the anterior side of the sleeve 2 and may extend radially around the circumference of the sleeve 2. The reinforcement layer 6 may extend symmetrically around sleeve from the center point of the anterior side to between approximately 50% to 75% of the total circumference of the sleeve. For TT amputees, the reinforcement layer 6 preferably does not extend completely around the circumference of the sleeve to allow the knee to have a greater range of motion. Having the reinforcement layer present around the entire circumference of a sleeve 2 designed for a TT amputee would undesirably restrict the motion of the wearer's knee.
Besides limiting the circumference of the reinforcement layer 6 for better knee flexion, the reinforcement layer 6 is formed from a textile material having a matrix of fibers which may be elastic in a longitudinal direction 14. The fibers of the textile material can have limited elasticity in a radial direction 16 to provide support while allowing for easy donning and doffing of the sleeve 2 and good proprioception. The reinforcement layer 6 also has an area of curvature 8 having a lesser longitudinal length on the anterior side to accommodate the knee of the wearer. The reinforcement layer 6 is preferably present directly below the knee area of the sleeve 2.
Due to the different needs of TT amputees and transfemoral (TF) amputees, the placement and properties of the reinforcement layer varies for sleeves for TT amputees and TF amputees.
The sleeve 18 may be worn on a residual limb in a similar manner to the exemplary embodiment in
As shown in
The reinforcement layer may be placed in a variety of locations within the thickness of the sleeve 2. As shown in
The reinforcement layer 6 is formed from a textile material with a sufficiently high tensile strength to withstand the pressure and forces applied to it by the elastic properties of the fabric layer and the silicone layer and the shearing force of the socket brim. It is preferable that the textile material is elastic in certain directions. However, the textile material the modulus of elasticity should not be too high. A balance between radial elasticity of the reinforcement layer and the tensile strength should be achieved to provide easy donning and doffing and good proprioception.
The textile material may be formed from a circular knit textile or a flat knit textile. Over one piece of textile may form the reinforcement layer 6 to provide different reinforcing effects. Any material that is more rigid than the polymeric layer 24 and has the desired characteristics described may be used to form the reinforcement layer 6 such as a polymeric mesh, knitted glass fiber, or Nylon.
The reinforcement layer 6 may be embedded between the silicone elastomer layer 24 and the fabric layer 26 for better sealing between the residual limb, the sleeve, and the socket. The reinforcement layer 6 may also be embedded between two silicone elastomer layers as described in U.S. Pat. No. 6,136,039, granted Oct. 24, 2000, incorporated by reference and belonging to the assignee of this disclosure. The reinforcement layer 6 may also be attached to the outer fabric layer of the sleeve using stitching or an adhesive.
Over one reinforcement layer 6 may be used with the embodiments described. The multiple reinforcement layers may be elastic or inelastic in different directions to combine to produce a more specific reinforcing effect. One reinforcement layer may be elastic in a radial direction and a second reinforcement layer is inelastic in the longitudinal direction.
The silicone elastomer layer 24 preferably has a consistent thickness throughout the sleeve to enable the sleeve to better mold to the surface contours of the residual limb and/or liner and socket. The silicone elastomer layer 24 may also have a greater thickness within the localized area 4 for a more durable reinforced area around the socket brim.
The fabric layer 26 of the sleeve is preferably elastic or elasticized. The fabric layer 26 may include one or more fabric sections including fabric sections having different elastic stiffnesses as described in U.S. Pat. No. 6,592,539, granted Jul. 15, 2003, incorporated by reference and belonging to the assignee of this disclosure.
The embodiments described may also be used with the peripheral profile features of the sleeve described in U.S. Pat. No. 7,169,189, ranted Jan. 30, 2007, incorporated by reference and belonging to the assignee of this disclosure to provide improved conformability, pressure distribution and stretchability to the sleeve.
The silicone elastomer layer 24 of the sleeve may have additional supplements such as petroleum jelly and aloe vera to improve skin care and comfort also described in U.S. Pat. No. 7,169,189.
From the features of the sleeve described above, the textile reinforcement layer provides reinforcement to select areas of a sleeve susceptible to shearing stress from the brim of a socket. Adding the textile reinforcement layer to the sleeve increases the overall durability of the sleeve while maintaining the sleeve's ability to conform to the contours of the residual limb and socket to create strong suspension of the prosthesis.
The reinforcement layer as described may be used similarly in a liner for reinforcement of select areas. Like a sleeve, a liner may have a polymeric interior layer bonded to a fabric outer layer where the polymeric layer forms an interface with the skin of the residual limb. The reinforcement layer or layers may be used in specific areas of the liner and provided in various locations within the thickness of the liner. The reinforcement layer or layers used in the liner may be formed from the material described with respect to the reinforcement layer.
The sleeve described may also be an orthotic sleeve to provide support to an area of a limb such as support and reinforce muscles or joints. The localized area may be aligned and oriented so the selected muscle or joints are within the localized area having a reinforcement layer.
While the foregoing embodiments have been described and shown, alternatives and modifications of these embodiments, such as those suggested by others, may be made to fall within the scope of the invention. The principles described may be extended to other types of prosthetic or orthopedic devices.
| Number | Date | Country | |
|---|---|---|---|
| 61589931 | Jan 2012 | US |
