2. Related Art Orthotic and prosthetic elasticized sleeves are described in U. S.

Patent Nos. 4,908,037 and 5,830,237. Such sleeves are fabricated of elastic or elasticized materials and may be used to support and reinforce muscles, joints and extremities of Lhose in need of such assistance and to provide an airtight seal between a residual limb of an amputee and an prosthesis socket worn by the amputee.

BRIEF SUMMARY OF THE INVENTION An orthotic or prosthetic sleeve is formed by joining sections of elasticized fabric shaped in tubular form and joined at their axial ends to form a tubular sleeve extending in an axial direction. The sleeve may be cylindrical or may be curved.

In accordance with one embodiment of the invention, the elasticized fabric used to make the sleeve sections exhibits different elastic stiffness in the lengthwise and widthwise directions of the fabric.

That is, the fabric is elastically stiffer in one direction than in a direction perpendicular to the one direction.

By joining together the fabric sections in a specified configuration, the sleeve will have at least one section having its direction of higher elastic stiffness extending in a direction transversely of the sleeve and at

least one section having its direction of higher elastic stiffness extending along the axial direction of the sleeve.

Other stiffening elements may be provided along the length of the sleeve in accordance with known principes to provide lateral rigidity to the sleeve.

The entire inner surface of the sleeve is coated with a discrete layer of silicone elastomer that is firmiy bonded to the fabric material constituting the sleeve. The silicone elastomer layer is thick enough and soft enough to be very comfortable to the user and to provide an airtight seal between the sleeve and the skin.

In a preferred embodiment, at least two elasticized fabric elements are connected together to define a tubular sleeve extending on an axis and having at least two fabric sections. The elasticized fabric constituting these sections has a higher elastic stiffness along one direction of the fabric than along an orthogonal direction relative to the said one direction. One of the at least two sections is formed so that the direction of higher stiffness of the fabric extends axially along the sleeve axis and the other section is formed so that the direction of higher stiffness extends generally transversely of the sleeve axis.

In accordance with one embodiment of the invention, at leastthree elasticized fabric elements are utilized to define the orthotic or prosthetic sleeve of the invention, wherein the elements are fabricated in tubular form and connected along their axial ends to define a tubular sleeve having two end sections and a middle section.

The end sections are formed so that the direction of higher elastic stiffness of the fabric extends axially along the sections and the middle

section is formed so that the direction of higher elastic stiffness of the fabric extends generally transversely of the sleeve axis.

The interior surface of the sleeve is entirely coated with a continuous, cured silicone elastomer material that forms a discrete layer on the inside surface of the sleeve.

The silicon elastomer preferably has a Shore 00 of 25-70; a minimum tensile strength of 230 Ibs/inch; a 100% modulus of 8 psi; a 200% modulus of 26; a 500% modulus of 61; a minimum tear strength of 49 Ibs/inch; a maximum tensile strength of 500 Ibs/inch; and an elongation of about 1000%.

The tubular sleeve in accordance with one embodiment may be provided with a curvature along a portion of its length and wherein the section having its direction of higher stiffness extending generally transversely of the sleeve axis is located along the curvature.

In a preferred embodiment, stiffening ribs are provided extending lengthwise of the sleeve on diametrically opposite sides thereof, the stiffening ribs being formed of relative inelastic material, for example a relative inelastic fabric.

A more detailed description of preferred embodiments of the invention is provided below and illustrated in the accompanying drawings.

DESCRIPTION OF THE DRAWINGS With reference to the appended drawings: Figure 1 is a side elevation view of one embodiment of an orthotic or prosthetic sleeve embodying the invention;

Figure 2 is a plan view of a pattern suitable to make one section of the sleeve shown in Figure 1; Figure 3 is a plan view of a pattern suitable to make another section of the sleeve shown in Figure 1; Figure 4 is a pattern suitable to make another section of the sleeve shown in figure 1; Figure 5 is a section view taken along line V-V of Figure 1; Figure 6 is a section view taken along line VI-VI of Figure 1; Figure 7 shows another embodiment of an orthotic or prosthetic sleeve embodying the invention; Figure 8 is another embodiment of an orthotic or prosthetic sleeve embodying the invention; and Figure 9 is a representative section view through a portion of an orthotic or prosthetic sleeve embodying the invention showing a lamination of an outer porous fabric and an inner discrete layer of cured silicone elastomer material.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION With reference to Figures 1-4, sections of eiasticized fabric 10,12 and 14 are cut along the patterns illustrated in Figures 2-4 and are then curved and sewn into tubular sections as shown in Figure 1 to form axially extending cylindrical sections A, B and C, respectively, that are sewn together along stitching fines 16,18 at their axial ends to form an axially extending tubular orthotic or prosthetic sleeve 20 that will be contoured in a relaxed state as illustrated in Figure 1.

The individual sections 10,12 and 14 each may be sewn along a lengthwise seam 22 along one side 24 of each section A, B or C of the sleeve 20 to form the individual tubular sections A, B and C.

The fabric used to make the sections 10,12 and 14 is selected from any suitable woven or non-woven tough, wear resistant elasticized fabric material that has elastic properties enabling the fabric to stretch within its elastic range in at least two orthogonal directions which, for the sake of convenience, may be referred to as lengthwise and widthwise of the fabric sections. One example of such an elasticized fabric is a material marketed under the name WEARFORCEw by E. I. Dupont de Nemours.

In accordance with the invention, an elasticized fabric section 10 having a higher elastic stiffness in the axial direction of the sleeve (as depicted by arrows 26 in Figures 1 and 2) as compared with the elastic stiffness of the section in a direction transversely of the sleeve is used to make one sleeve section A and likewise the fabric section 14 used to make section C of sleeve 20 possess higher elastic stiffness in the axial direction of the sleeve as shown by arrows 2B in Figures 1 and 4 as compared with the elastic stiffness of the section transversely of the sleeve.

That is, elasticized fabric sections 10 and 14 exhibit higher elastic stiffness in the longitudinal or axial direction of the fabric sections when they are made up into the sleeve sections A and C relative to the elastic stiffness of the sections in a direction essentially transversely of or orthogonal to the directions depicted by arrows 26. If the fabric constituting sections 10 and 14 are made of woven yarns, for example, typically the sections will have a higher elastic stiffness along the

"length"of the fabric in the direction of the warp yarns as compared with the elastic stiffness in the transverse"widthwise"direction corresponding to the direction of the fill or weft yarns.

On the other hand, any suitable woven or non-woven fabrics including textiles that possess different elastic stiffness properties in perpendicular or orthogonal directions can be used to form the sleeve of the invention.

Middle fabric section 12 is cut from an elasticized fabric in accordance with the pattern shown in Figure 3 so that the direction of higher elastic stiffness of the fabric section 12 extends along the direction depicted by arrow 30. When shaped and stitched to form the middle section B of the sleeve 20 as shown in Figure 1, the direction of higher stiffness of the fabric section 12 will extend generally transversely of the axial direction of the sleeve 20. It will be apparent that the direction of higher stiffness shown by arrow 30 is generally perpendicular to the direction of higher stiffness depicted by arrows 26 and 28 associated with sleeve sections A and C. If a curvature is formed in the sleeve 20 as shown in Figure 1, the direction depicted by arrow 30 may not be precisely perpendicular to the directions depicted by arrows 26 and 28 and likewise the directions depicted by arrows 26 and 28 may not extend in parallel or collinear directions. However, the intended result of providing differential elastic stiffness properties to the sleeve 20 will be obtained provided that the principal direction of higher elastic stiffness of the fabrics 10 and 14 extend generally along directions that correspond to the general axial direction of the sleeve section formed by the sections and if the principal direction of higher elastic stiffness of the

fabric section 12 extends generally transversely of the axis of the sleeve section formed by the fabric 12.

A stiffening rib 32 preferably formed from a relative inelastic woven or non-woven fabric is sewn along one side of the sleeve 20 in the axial direction thereof and a similar stiffening rib (not shown) is stitched along the opposite side of the sleeve 20 in a direction parallel with the rib 32. Each stiffening rib 32 preferably is continuously attached to the sleeve 20 along its length by a suitable connection which may include adhesive, stitching, or other connecting arrangements that will firmly secure the rib 32 continuousiy along the side of the sleeve 20.

To assist in the fabrication of the sleeve 20, and in particular to provide a guide for sewing the rib 32 to the sleeve sections A, B and C, each section may be provided with visible indicia in the form of guide lines 34,36 that will be visible to a sewing machine operator or other assembly worker when the sections 10,12 and 14 are curved into tubular sections and stitched or connected together, and that can be used to guide the placement of the stiffening rib 32 onto the side of the sleeve 20 where it will be firmly secured to the sections A, B and C as shown for example in Figure 1.

Figure 5 is a cross section view taken along section line V-V showing rib 32 stitched to the outer surface of fabric section 10.

After the sleeve 20 has been fabricated in the manner described above by joining sections A, B and C, the inside surface of the entire sleeve is coated with a cured silicone elastomer (40) material that is firmly bonded as a discrete layer with the interior surface of the fabric sections 10,12 and 14. The silicone elastomer material on the inside surface of the sleeve 20 is shown in Figures 5 and 6.

The cured silicone elastomer material may be applied by coating, film casting, injection molding or any other suitable process that will produce an air impermeable discrete elastomeric coating on the inside surface only of the sleeve 20 to provide an airtight sleeve that may be used in prosthetic applications as a seal between a residual limb and the proximal end of a prosthetic socket, particularly a below-the-knee (BTK) socket used to connect a residual limb with a prosthesis (e. g., a leg and foot).

When used in an orthotic application, the silicone elastomer coating optionally may be omitted to provide a flexible elasticized sleeve having differential elastic stiffness properties in the axial and transverse directions.

Preferably, the fabric used to make sections 10,12 and 14 is porous and a cured silicone elastomer material 40 is partially impregnated into the porous structure of the fabric as shown, for example, in Figure 9 where fabric section 10 is provided with a cured silicone elastomer material 40 on its inner side with the elastomer material forming a discrete layer partially impregnated into the porous structure of the fabric 10.

It will be evident that when the silicone elastomer material 40 is bonded with the fabric 10, the elastic properties of the combined laminated material will reflect the composite elastic properties of the elasticized fabric 10 and the elastomer material 40. That is, the composite laminate will exhibit higher elastic stiffness in one direction than in an orthogonal direction but the degree of elasticity normally exhibited by the elasticized fabric will be modulated to some extent by the elasticity of the silicone material.

If the sleeve 20 is to include a curvature as illustrated in Figure 1, the curvature can be established by the shapes of the fabric pattern sections 10,12 and 14 and the curvature can be reinforced by application and/or curing of the silicone elastomer material 40 while it is being bonded to the fabric of the sleeve and while the fabric is in its final desired sleeve configuration, including its curvature.

If desired, the fabric sections of the sleeve 20 may be elastically distended in a desired direction or curvature while the silicone elastomer is bonded thereto and cured to provide a permanent set to the fabric of any of the sections A, B or C or of the entire sleeve in such distended configuration.

The sleeve 20 may be formed without a curvature as shown in Figure 7 which illustrates another embodiment of the invention. In accordance with Figure 7, fabric sections 10', 12'and 141 may be rolled and sewn and otherwise joined together to form sleeve sections A', B1 and C'. Tubular sleeve sections A', B'and C'are joined by stitching or otherwise connected smoothly along their axial ends as shown at 161, 18'to form a cylindrical orthotic or prosthetic sleeve 201. This embodiment of the orthotic or prosthetic 20'is fabricated using fabric sections 101 and 141 that correspond to fabric sections 10 and 14 of Figures 2 and 4, that is, the fabric of sections 10'and 141 both exhibit higher elastic stiffness in the direction of arrows 261 and 28' (lengthwise of the fabric) than in a direction generally perpendicular to the direction of said arrows (widthwise of the fabric). When fabricated into the sleeve sections A'and C', the direction of higher elasticity of the fabric in each section extends along the directions of arrows 26'and 281 as shown in Figure 7.

In a similar manner, the fabric section 12'when fabricated into the middle section Bu ouf orthotic of prosthetic sleeve 20'exhibits higher elastic stiffness in the direction of arrow 30'that extends generally transversely of the axial direction of sleeve 20'.

Sleeve 20'may be entirely coated on its interior surface with a discrete layer of cured silicone elastomer material 401 in the same manner as described previously in regard to the embodiment of the sleeve 20 shown in Figure 1. If desired, the sleeve 20'may be deformed out of a purely straight cylindrical form into any desired shape or configuration by thermal or other setting procedures applied to the fabric or by coating and curing the silicone elastomer material on one side (the inside) of the fabric sections 101,12'and 14'with the fabric distended or curved in a desired configuration so that the fabric and silicone elastomer composite takes a permanent set in accordance with the curvature established during the silicone elastomer coating and curing procedure.

Optionally, a stiffening rib 30'may be utilized on opposite sides of the sleeve 20', such reinforcing rib 32'being secured to the outer surface of the sleeve 20'in a manner similar to the rib 32 described previously in connection with the embodiment shown in Figure 1.

Another embodiment of the invention is shown in Figure 8 where an orthotic or prosthetic sleeve 202 is illustrated. In accordance with the embodiment shown in Figure 8, the sleeve 202 is formed of two sections of elasticized fabric that have been cut and seamed into a first tubular section 102 and a second tubular section 122. The sections 101 and 122 are cut from patterns that can be joined along their edges to form a generally elongated cylindrical sleeve 202 having sections A2 made of fabric section 102 and section B2 made of fabric 122, the fabric sections

being joined by stitching or other suitable joining procedures to form, for example, a curved sleeve 202 from sections A2 and B2. Each fabric section has different elastic stiffness in generally perpendicular directions.

The sleeve section A2 is made from a fabric having its higher elastic stiffness extending in the direction of arrow 262 that extends generally lengthwise of the sleeve 202 and the section B2 is made of a fabric having its higher elastic stiffness direction extending as shown by arrow 302, that is, generally transversely with respect to the longitudinal direction of sleeve 202.

If desired, a relative inelastic stiffening rib 322 may optionally be applied to the diametrically opposed sides of the sleeve 202 in the same manner as described previously in connection with sleeve 20 shown in Figure 1.

The sleeve 202 like the sleeves of the embodiments of the invention described previously may be entirely coated on its interior surface with a cured silicone elastomer material (not shown) that corresponds with the discrete coating or layer of elastomer material 40 described previously with regard to the embodiment of the invention shown in Figure 1.

The silicone elastomer material 40 preferably has a Shore 00 of 25-70; a minimum tensile strength of 230 Ibs/inch; a 100% modulus of 8 psi; a 200% modulus of 26; a 500% modulus of 61; a minimum tear strength of 49 Ibs/inch; a maximum tensile strength of 500 Ibs/inch; and an elongation of about 1000%.

The silicone elastomer material 40 used in the orthotic or prosthetic sleeves described above may be of uniform thickness in both circumferential and longitudinal directions or may have a varying

thickness to accommodate varying anatomical shapes, protrusions, contours, etc. Various relief pads may be provided within the bodies of the sleeve embodiments described above to provide specific relief from localized pressure that may result from installation of the sleeve on a human limb or residual limb.

An overlock stitching 42 may be used at opposed ends of the sleeve (Figure 1) to overlap and cover both fabric and silicone coating material to facilitate rolling up the sleeve, to provide an attractive appearance, and to reinforce and enhance the sealing ability of the sleeve at its ends.

In use, the sleeves described herein may be donned over a limb by a well known unrolling technique from a rolled up configuration if utilized for orthotic purposes to reinforce muscles and joints along desired directions of support. For example, the sleeves may be used in a knee or elbow area of a limb to provide stiffer support transversely of the knee or elbow joint in the central area B, B'and B2 of the sleeve while providing a softer, more elastic support in these central areas in a longitudinal direction. Likewise, the end sections A, C', A2 of the sleeves provide a stiffer elastic support for the joint and limb area along the axial direction of the sleeves as compared with the transverse direction. The sleeves will be sized to be somewhat smaller in a relaxed state than a limb area on which the sleeve is to be installed, and several size sieeves can be made to accommodate a wide range of limb sizes.

The use of a layer of silicone elastomer material on the interior surface of the sleeve enables the sleeve to fit snugiy against the skin of the user in a very comfortable manner due to the ability of the silicone elastomer to absorb and react sheer loads between the skin and the

fabric layer of the sleeve. The silicone elastomer material when in direct, airtight contact with the skin of the user holds back moisture in the skin of the user, thereby preventing perspiration or moisture to pass into the region between the skin of the user and the sleeve.

When the sleeve is used in a prosthetic application to provide an airtight seal between the residual limb of a user and the proximal end of a prosthetic socket, the silicone elastomer provides an airtight seal between the skin and the prosthetic socket while the elasticized fabric sections provide a comfortable interface between the residual limb and the socket. Again, the sleeve will be unrolled from a rolled up condition for donning on a residual limb and will be sized somewhat smaller than a residual limb and a prosthetic socket to ensure an airtight fit between the residual limb, the sleeve and the socket.

While only a pair of stiffening ribs 32,32'and 322 have been illustrated, it will be understood that more than two such ribs may be utilized and that the ribs may be configured in different patterns to provide specific axial stiffness along certain directions of the orthotic or prosthetic sleeves described herein.

While a cured silicone elastomer material is described herein as the preferred interior covering material for the sleeves, other elastomeric or gel materials may be utilized to provide an interiayer between the fabric of the sleeve and the skin of a user.

The orthotic or prosthetic sleeve of the invention may be constructed by using other shapes or patterns of fabric other than those described herein, provided that they may be assembled together to form an orthotic or prosthetic sleeve wherein the elasticized fabric constituting the sleeve sections exhibit higher elastic stiffness along one direction of

the fabric than along an orthogonal direction relative to the one direction.

It would be possible, for example, to form sections A, B and C each from multiple fabric patterns sewn or otherwise connected together to form the individual sections.

The stiffening ribs 32,32'and 322 also could be fabricated in the form of a pocket that could receive a separate stiffening element such as a plastic or metallic rod or band that would provide an enhanced stiffening function in and of themselves or in combination with the ribs.

It will be evident to those skilled in the art that the orthotic or prosthetic sleeve according to the invention can be constructed in different forms, shapes and configurations other than those specifically described herein without departing from the spirit and scope of the invention as defined in the appended claims.