JPH0533628B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to composite materials used in the manufacture of orthopedic supports with improved use properties.
More specifically, this composite material has a novel property of elasticity and good compressive support, shear resistance, and sufficient air and water porosity to avoid user thermal discomfort and perspiration during long-term use. Offer a combination.

BACKGROUND OF THE INVENTION Orthopedic supports come in a variety of forms. A common orthopedic brace is a rigid knee brace worn by those who suffer from knee instability and those who engage in sports activities to prevent knee damage. The general purpose of a knee brace is to provide external support to the knee joint that prevents unnatural movements of the knee joint that could damage or reinjure the knee joint, while still allowing normal rotational movement of the knee joint. It is to be. This type of knee immobilizer is commonly used for post-operative patients undergoing knee surgery. Knee braces of this type generally include a metal rod and a pivot joint to provide a rigid means of support. Knee braces of this type are sold only by medical prescription and require a skilled orthotist to properly fit them on a patient.

Other orthopedic braces are so-called "soft braces" sold in pharmacies, hospitals and doctor's offices. Soft braces provide moderate support to the injured joint. This type of support does not include hard metal rods or stays, but is simply made of soft elastic material. These are often sold without a prescription and do not require installation by a trained professional.
Soft orthopedic supports have been used for many years and are commonly available as knee, ankle, thigh, wrist, elbow, chest or lower back supports. These soft supports are commonly used for sprains and strains, arthritis, tendinitis, cystitis, inflammation, or to reduce discomfort during postoperative use, or to treat post-traumatic discomfort. worn for.

Soft orthopedic supports are often made from neoprene rubber. This material is desirable because it has a combination of favorable properties useful in orthopedic supports. Neoprene rubber has good flexibility and relatively high density, the combination of which provides good compressive support and shear resistance.

Because neoprene rubber is a closed cell material, it does not necessarily dissipate heat very well in use. Its closed cell nature helps retain heat during use by reflecting emitted heat back into the bones and joints of the affected area. This localized concentration of heat aids in venous blood flow and helps reduce edema, making soft tissues less susceptible to injury.

Although the use of neoprene rubber in orthopedic supports is useful because it can concentrate heat, the natural tendency of closed cell properties to prevent heat dissipation creates problems for the user. The neoprene rubber brace is stretched to compress the diseased area when worn. This tight compression device, combined with the high density of the material and the material's lack of air circulation and dissipation, creates thermal discomfort and sweating, often causing heat rashes. Prolonged use of such neoprene rubber braces can cause the user to sweat constantly, causing such discomfort that the user often stops wearing the brace prematurely. In effect, the material itself dictates how long the orthopedic brace can be worn. If the user uses this type of support for approx.
It is not unusual for the wearer to stop wearing it after two hours.

Replacing closed cell neoprene rubber with open cell material does not provide an acceptable solution to the problem of thermal discomfort. Open cell materials, such as sponge rubber or plastic cell materials, such as high density polyester or polyurethane foams, are materials that are characterized by their "breathable" properties. That is, they are porous to air and water. This type of material can ensure good air circulation and good heat dissipation and body fluid absorption during use. However, this type of open cell material does not inherently have the high density necessary for the material to have sufficient compressive strength for use as an orthopedic brace.

Thus, it has sufficient elasticity and density to provide the required level of compression-type support, while being sufficiently active to avoid excessive sweating and thermal discomfort when using the brace for long periods of time. There is a need for orthopedic supports that dissipate heat.

There is also a need to provide a liner for use with an amputee prosthesis. Custom molding of permanent prosthetic liners is time consuming and expensive. Additionally, these liners wear out and must be replaced with custom liners.
This cost will increase. Furthermore, as the patient gains or loses weight, the volume of the residual limb changes. Accordingly, there is a continuing need to provide a liner that provides an accurate and comfortable fit between the residual limb and the socket of a permanent prosthesis. Closed cell materials can also cause thermal discomfort during long-term use because they cannot "vent", ie, provide sufficient air circulation to the protected area.

SUMMARY OF THE INVENTION In summary, the present invention provides a flexible, resilient multi-component material for use in the manufacture of resilient orthopedic supports for compressive support of body parts.
The composite material is in the form of a sheet and includes a base layer of a flexible elastomeric closed cell material having a large number of pores extending through the depth of the sheet and fractionated over the surface of the sheet. A first skin protection layer made of a soft, flexible and resilient porous fabric is the first base layer.
attached to the surface. A second protective layer of soft resilient porous fabric is applied to the second, opposite side of the base layer. The composite material is porous to air and water, which penetrate the depth of the composite material. When used as an orthopedic support, this allows sufficient air circulation to avoid sweating and thermal discomfort during long-term use. The pores in the elastomeric base layer of closed cell material together with the porous first and second layers of knitted fabric;
Increase air circulation during use and reduce heat buildup. The high density of closed cell materials provides sufficient compressive support to the diseased area during use. The first and second knitted fabrics provide elasticity on opposite sides of the elastomeric base layer. These increase the strength of the composite material to overcome any degree of elasticity or strength lost due to the pore pattern added to the elastomeric base layer. Trial use of orthopedic braces made from this composite material demonstrated a substantial improvement in the absence of sweating and associated thermal discomfort with long-term use.

The present invention also includes a novel orthopedic brace made from a novel composite material. Additionally, prosthetic limb socks made from this composite material have a useful combination of elasticity and compressive support, while being porous enough to avoid thermal discomfort and sweating during long-term use. It is.

These and other aspects of the invention will be more fully understood by reference to the following detailed description and accompanying drawings.

FIG. 1 is a semi-schematic side elevational view of a knee brace made from orthopedic material in accordance with the principles of the present invention.

2 is a semi-schematic perspective view of the knee support shown in FIG. 1; FIG.

FIG. 3 is a cross-sectional view schematically showing the constituent elements of the orthopedic composite material of the present invention.

FIG. 4 is a partial plan view showing the porous closed cell elastomer layer of the composite material of the present invention.

FIG. 5 is a perspective view of an elbow support made from the composite material of the present invention.

FIG. 6 is a perspective view of a wrist support made from the composite material of the present invention.

FIG. 7 is a side view of an ankle support made from the composite material of the present invention.

FIG. 8 is a side elevational view of a completed prosthetic stocking made from composite material in accordance with the principles of the present invention.

FIG. 9 is a portion of a schematic cross-sectional view taken along line 9--9 in FIG.

FIG. 10 is a partial plan view showing the porous closed cell elastomer layer of the composite material of the present invention.

DETAILED DESCRIPTION FIGS. 1 and 2 illustrate a knee brace 10 made from orthopedic material in accordance with the principles of the present invention. The orthopedic material is shown in FIGS. 3 and 4.
The knee brace is a soft orthopedic brace constructed entirely from a flexible, resilient composite material 12 shown in flat form in FIGS. 3 and 4. The flat composite material is folded and sewn to form the final cylindrical knee brace 10 shown in FIGS. 1 and 2.

For Figures 1 and 2, the flat sheet composite piece is folded over and cut inward from the center of the overlapping longitudinal ends opposite the fold. The cutout is a V-shaped region extending from the overlapping longitudinal ends toward the opposite fold. Along the central region of the folded material, each overlapping end is fastened with left and right stitched seams, 14 and 16, respectively. The overlapping longitudinal ends opposite the fold are fastened by a long straight seam 18. This results in a generally cylindrical sloped knee support with an open top 20 and an open bottom 22. An edge stitch 24 at the top end and a similar edge stitch 26 at the bottom end provide the final termination for the completed knee brace.

The materials that make up composite material 12 are best understood by reference to FIGS. 3 and 4. The composite material is a thin sheet of flexible bendable elastomer base layer 28 formed from a closed cell material.
including. A preferred elastomeric closed cell material is neoprene rubber. The neoprene rubber layer 28 has a number of holes 3 distributed over the entire surface of the neoprene rubber layer and extending through the entire depth of the neoprene rubber layer.
0 are perforated so that fluid can pass through these holes from one side of the layer to the other. Hole 30 is not shown in FIG. 3 for simplicity. Although the hole pattern shown in Figure 4 is slightly exaggerated in relative dimensions, it is a uniform pattern with all holes being of uniform diameter and evenly spaced over the surface of the neoprene rubber layer. A preferred method of forming pores is shown. In one form, the neoprene rubber layer has a pore size of approximately 2.3 mm (0.090 inch) with a uniform pattern of adjacent pores having center-to-center spacing of approximately 0.090 inch.
It has 6.4mm (1/4 inch). A preferred neoprene-based material is manufactured by Labatex Corporation (Bedsford, VA) under stock number G.
-231-N, G-207-N or R-411-N. These materials are approximately 0.12~
It has a density of 0.48 g/cm ³ (about 10 to about 30 pounds/ft ³ ). In testing, these materials gave good results when used in orthopedic supports. The dimensions of the pores and their distribution on the surface of the neoprene rubber layer are important when this material is used in orthopedic supports.
These holes are what allow heat to dissipate quickly. The pores, the overall elasticity or density of the neoprene rubber layer, should not be so large or so closely spaced that the material's ability to provide adequate orthopedic compressive support in use. A useful hole pattern is one in which the total area of the holes within a section of the flat material accounts for about 3 to about 10% of the total area of the perforated sheet section. A preferred perforation pattern is about 50% of the surface area of a perforated sheet section.
%. Increasing the aggregate area of holes within a given sheet reduces elasticity and strength. However, the density of the material can be increased proportionately to compensate and maintain the required level of elasticity and resulting orthopedic compression force. The desired thickness of the neoprene rubber layer is approximately 3.2 mm (1/8 inch). about
Good results have been obtained with sheet thicknesses from about 1/16 to about 1/4 inch.

A preferred method for forming the hole pattern in the neoprene rubber layer is roller molding, in which the roller (not shown) is provided with a cylindrical outer surface from which punches of the desired hole pattern protrude; By rolling a roller over the flat surface of the neoprene rubber sheet, holes in the desired pattern are punched out.

The composite material also includes a soft, flexible, resilient porous inner skin barrier layer 32. A presently preferred material is known under the trademark Tricot. This material is a knitted, flexible, foldable stretch fabric that is porous to air and water due to the pores inherently formed by the knitted fabric. Therefore, the individual pores of the perforated neoprene rubber layer are substantially larger in area than the individual pores formed by the knitted fabric. The pores in the neoprene rubber layer are at least an order of magnitude larger in area.

The composite material has a flexible elastic porous protective outer layer 34.
Also includes. It is also formed from a stretchable knitted fabric. This protective outer layer is preferably formed from a material sold under the trademark Tricot.

The inner and outer layers, 32 and 34, may be made of other stretch knitted fabrics such as nylon, Dacron, or other synthetic fibers.

In the flat material shown in FIGS. 3 and 4, the inner layer 32 and outer layer 34 are the perforated neoprene base layer 28.
Cover each side on the opposite side. After perforating the neoprene rubber layer, the inner and outer fabric layers are adhered to each opposite side of the perforated base layer. Conventional adhesives provide the desired surface adhesion over the entire contacting surface area of the perforated base layer and the adjacent knitted fabric layers 32 and 34. The adhesive does not interfere with the porosity of the perforated base layer and knitted fabric layers 32 and 34.

Knee braces made from this composite material have sufficient porosity that internal heat build-up is essentially avoided during use. Composite material 12 of the present invention
Testing of a knee brace made by the company demonstrated that the knee brace was sufficiently breathable to be worn for two hours without excessive sweating or other thermal discomfort. . In contrast, the same knee brace made of an otherwise identical composite material except that the neoprene layer was not perforated sweated almost immediately and was uncomfortable to wear for the same two hours. It is believed that the knee brace of the present invention can be worn for an indefinite period of time without problems with sweating or thermal discomfort. The level of compression type support provided by the knee brace of the present invention was also sufficient for the purpose for which the knee brace was intended.

The knee brace is sufficiently elastic and dense enough to provide the necessary compression for use as a useful knee brace. Any elasticity lost due to pores in the neoprene rubber layer can be compensated for by correspondingly increasing the density of the neoprene rubber layer. Further, inner and outer layers 32 and 34 of resilient and flexible knitted fabric;
are themselves resilient and enhance the elasticity of the perforated neoprene rubber, so that the composite material has the level of elasticity required for orthopedic applications. The inner and outer layers of resilient knitted fabric also add strength to the composite material. It has been found that the removal of the inner fabric layer does not result in a useful orthopedic support. This is because direct contact of relatively large pores in the perforated neoprene rubber layer with the skin causes discomfort to the user. The pores naturally formed in the knitted inner layer provide good porosity for air circulation. The inner layer of resilient fabric enhances comfort and adds useful levels of elasticity and strength to the overall composite material. A preferred combination is provided by an inner and outer layer of knitted fabric each having a resiliency greater than that of the perforated neoprene rubber layer.

The materials constituting the inner layer and the outer layer may have different elasticities in directions perpendicular to each other. This material has greater elasticity in the resulting orthopedic brace in the transverse direction, i.e. parallel to its upper and lower edges, while the resulting orthopedic brace has greater elasticity in the longitudinal direction, i.e. in the upper and lower edges of the brace. It can be used in combination with a perforated neoprene layer, with greater tensile resistance in the vertical direction.

Figures 5-7 illustrate other uses of composite material 12 in orthopedic supports. Figure 5 shows an elbow support 36 in which the composite material is folded along its length and sewn along its length with a central seam 38 to form a slightly L-shaped cylinder. form an elastomeric support. The upper and lower ends of the cylindrical support have stitched edge seams 40 for edge reinforcement. FIG. 6 shows a wrist support 42 made from composite material 12. FIG. In this case, the material is folded lengthwise and sewn to form a right cylindrical support with edge stitches 44 at each opposite end for edge reinforcement. FIG. 7 shows an ankle support 46 made from a composite material. The ankle brace has an edge stitch 48 at each opposite end thereof, an edge stitch 50 at the distal end portion of the brace that fits around the user's heel, and an intermediate stitch 52 for securing the intermediate end of the L-shaped ankle brace. It is formed as a generally L-shaped cylindrical support with a cylindrical support.

These supports can be used to provide the required level of anatomical compression type support while improving air circulation to the support area to a degree sufficient to prevent discomfort caused by sweating and overheating. . Thus, the improved composite materials of the present invention themselves contribute to the improved anatomical support provided by these orthopedic supports. This is because the user can wear the brace for an unspecified period of time without having to prematurely remove the brace due to thermal discomfort.

Figures 8-10 illustrate another form of the present invention comprising a prosthetic limb sock made from a flexible, resilient composite material. It includes a base layer of a thin sheet of flexible elastomeric closed cell material with a large number of holes extending through the depth of the sheet and distributed over the surface of the sheet. A first skin protection layer of a soft, resilient porous fabric is attached to the first side of the base layer. A soft resilient porous fabric is attached to the second side of the base layer. The composite material is porous to air and water, which penetrate the depth of the composite material. When the composite material is formed into a prosthetic stocking, it allows sufficient air circulation to avoid sweating and thermal discomfort during long-term use. The pores in the elastomeric base layer of closed cell material, together with the porous first and second layers of knitted fabric, enhance air circulation and reduce heat build-up during use. The high density closed cell material, enhanced by the strength and elasticity of the first and second fabric layers, provides a compression type support sufficient for use as a prosthetic stocking.

FIG. 8 shows a prosthetic stocking 62 made from the orthopedic composite material of the present invention. The orthopedic material is shown in FIGS. 9 and 10. This flat shaped composite material is cut, folded, sewn at 66 and edge stitched at 68 to form the final prosthetic stocking shown in FIG.

The materials comprising composite material 64 include a thin sheet of flexible bendable elastomer base layer molded from a closed cell material, preferably neoprene rubber. The neoprene rubber layer 70 is perforated with holes 72 distributed over the entire surface of the neoprene rubber layer and extending through the entire depth of the neoprene rubber layer so that fluid can flow through these holes from one side of the layer to the other. can pass to.

The composite material also includes a soft, flexible, resilient porous skin barrier inner layer 74, preferably a tricot.

The composite material has a flexible elastic porous protective outer layer 76
Also includes. It is also made from a stretch knitted fabric, preferably tricot.

The inner and outer layers, 74 and 76, may be formed from other stretch knitted fabrics such as nylon, Dacron, or other synthetic fibers.

In the flat form of material shown in FIGS. 9 and 10, an inner layer 74 and an outer layer 76 cover opposite sides of the perforated neoprene base layer. After perforating the neoprene rubber layer, the inner and outer fabric layers are adhered to each opposite side of the perforated base layer. A perforated base layer and an adjacent knitted fabric layer, 74, by a conventional spray applied adhesive.
and 76, the desired surface adhesion is obtained over the entire contact surface area.

Prosthetic stockings made from this composite material have sufficient porosity that internal heat build-up is essentially avoided during use. Testing of prosthetic stockings made from the composite material of the present invention has shown that the prosthetic stockings are sufficiently breathable to be worn for two hours without excessive sweating or other thermal discomfort. This has been proven. In contrast, the same prosthetic stocking made from an otherwise identical composite material except that the neoprene layer was not perforated sweated almost immediately and was uncomfortable to wear for the same two hours. It is believed that the prosthetic stockings of the present invention can be worn for an indefinite period of time without problems with sweating or other thermal discomfort.

The present prosthetic stocking is sufficiently elastic and dense enough to provide the necessary compression for use as a useful prosthetic stocking. Any elasticity lost due to pores in the neoprene rubber layer can be compensated for by correspondingly increasing the density of the neoprene rubber layer. Furthermore, the inner and outer layers, 74 and 76, of resilient and flexible knitted fabrics are themselves resilient and enhance the elasticity of the perforated neoprene rubber, thus ensuring that the composite meets the required levels of orthopedic applications. It has elasticity. The inner and outer layers of resilient knitted fabric also add strength to the composite material. It has been found that the removal of the inner fabric layer does not result in a useful orthopedic support. This is because direct contact of the perforated neoprene rubber layer with the skin causes discomfort to the wearer. The inner layer of resilient fabric enhances comfort and adds useful levels of elasticity and strength to the overall composite material. A preferred combination is provided by inner and outer layers of knitted fabric each having an elasticity greater than that of the perforated neoprene rubber layer.

The materials constituting the inner layer and the outer layer may have different elasticities in directions perpendicular to each other. This material allows the resulting orthopedic brace to have greater elasticity in the transverse direction, i.e. parallel to its upper edge, while the resulting orthopedic brace has greater elasticity in the longitudinal direction, i.e. in the direction perpendicular to the upper edge of the brace. It can be used in combination with a perforated neoprene layer, with a high tensile resistance.

Temporary prosthetic stockings and permanent prosthetic stockings can be obtained using this orthopedic composite material. These prosthetic stockings are used in the manner described above for the temporary and permanent stockings shown in FIGS. 1-7.
Prosthetic stockings made from this composite material provide the required level of anatomical compression type support while allowing sufficient air circulation to the support area to prevent discomfort caused by sweating and overheating. Improve. Thus, the improved composite material of the present invention itself contributes to the improved anatomical support provided by this prosthetic stocking. This is because users can wear these stockings for an indefinite period of time without prematurely removing them due to thermal discomfort.

[Brief explanation of the drawing]

FIG. 1 is a semi-schematic side elevational view of a knee brace made from the orthopedic composite material of the present invention. 2 is a semi-schematic perspective view of the knee support shown in FIG. 1; FIG. FIG. 3 is a cross-sectional view schematically showing the structure of the composite material of the present invention. FIG. 4 is a partial plan view showing the perforated closed cell elastomer layer of the composite material of the present invention. Figures 5-7 are perspective views of elbow, wrist and ankle supports, respectively, made from the composite material of the present invention. FIG. 8 is a side elevational view of a prosthetic stocking made from the composite material of the present invention. FIG. 9 is a portion of a schematic cross-sectional view taken along line 9--9 in FIG.
FIG. 10 is a plan view showing the porous closed cell elastomer layer of the composite material of the present invention. In each figure, the numbers represent the following: 10: Knee support, 12, 64: Composite material, 1
4, 16, 18, 38, 48, 52, 66: seam, 20: top (open), 22: bottom (open), 2
4, 26, 40, 44. 50, 68: edge step, 28, 70: base layer, 30, 72: hole, 32,
74: First layer (inner layer), 36, 76: Second layer (outer layer), 42: Wrist support, 46: Ankle support, 6
2: Stockings for prosthetic limbs.

Claims (1)

[Claims] 1. A flexible resilient composite material used for manufacturing an elastic orthopedic compression support for surrounding and compressive support of a body part, which is: in the form of a thin sheet; a porous substrate comprising a flexible closed cell elastomeric material having a large number of pores extending through the entire depth of the sheet and distributed over the surface area of the sheet, the closed cell elastomeric material providing an orthopedic compression support; the sheet-like base layer having sufficient elasticity and a density of ^at least about 10 pounds/ ^ft3 to provide skin protection comprising a soft resilient elastic porous fabric attached to a first side of the base layer; and a protective second layer consisting of a flexible, resilient, porous fabric attached to an opposite second side of the base layer, the first and second layers being means for increasing the resiliency of the porous base layer. , such that the composite material consisting of the base layer, first layer and second layer combination maintains sufficient elasticity and density to provide a useful level of orthopedic compression type support, and the composite material Porous to air and water, which penetrate the depth of the composite material and provide a means for heat and moisture dissipation to the enclosed body parts during use of these orthopedic compression supports. composite material. 2. A knitted fabric in which the first layer and the second layer have pores naturally formed in the fabric, and each pore in the base layer has an area substantially larger than the area of each pore formed in the knitted fabric. The composite material according to claim 1, comprising: 3. Composite material according to claim 1 or 2, wherein the base layer is made from neoprene rubber. 4. A composite material according to claim 1 or 2, wherein the pores occupy about 3-10% of the surface area of the base layer. 5. Orthopedic compression-type supports for enclosed body parts supporting body joints such as knees, elbows or wrists, where composite materials are sewn together to form a cylindrical support open at both ends. an orthopedic support for use in performing an orthopedic surgery, the composite material: being in the form of a thin sheet and having a large number of holes extending through the entire depth of the sheet and distributed over the surface area of the sheet; a porous base layer comprising a flexible closed cell elastomeric material having an elasticity sufficient to provide orthopedic compression type support and at least about 10 pounds/ft ³ (0.12 g/cm ³ ); the sheet-like base layer having a density of; a skin protective first layer consisting of a flexible resilient elastic porous fabric attached to a first side of the base layer; and a flexible resilient elastic layer attached to an opposite second side of the base layer. A flexible resilient composite material consisting of a protective second layer of porous fabric, the first and second layers providing a means of increasing the elasticity of the porous base layer, thereby making the base layer, the first layer and the second layer The composite material maintains sufficient elasticity and density to provide a useful level of orthopedic compression support, and the composite material is porous to air and water so that these Orthopedic braces that penetrate the depth of the material, thereby providing a means for heat and moisture dissipation to the enclosed body part during use of these orthopedic compression braces. 6 A knitted fabric in which the first layer and the second layer have pores naturally formed in the fabric, and each pore in the base layer has an area substantially larger than the area of each pore formed in the knitted fabric. The orthopedic support device according to claim 5, comprising: 7 Closed cell elastomer material is about 0.12 to about
7. The orthopedic brace of claim ⁵ or 6, having a density of about 10-30 pounds/ft ^<3> . 8. An orthopedic brace according to any of claims 5 to 7, wherein the closed cell base layer is made from neoprene rubber. 9 The thickness of the base layer of elastomeric material is from about 1.6 to about
Claim 1: 6.4 mm (approximately 1/16 to approximately 1/4 inch)
Or the orthopedic material according to 2.