DESC:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003

COMPLETE SPECIFICATION
[See section 10, Rule 13]
A COMPOSITE MATERIAL FOR ORTHOPEDIC SUPPORTS AND A PROCESS THEREOF
ARVIND LIMITED, A COMPANY INCORPORATED UNDER THE COMPANIES ACT, 1956, WHOSE ADDRESS IS NARODA ROAD, AHMEDABAD - 380025, GUJARAT, INDIA

THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED
Field of the invention
The present invention generally relates to the field of orthopedic aids and more particularly, to a composite material for orthopedic supports and brace, and a process for manufacturing the same.

Background of the invention
Orthopedic supports are used to provide structural support and/or limit movement of a portion of a patient's anatomy. Orthopedic supports are commonly used after surgery or for treatment of injury to a joint. Presently available supports are Neoprene laminated with polyester knitted fabric, Compressed Polyurethane foam laminated with nylon spandex fabric, Cotton-latex knitted braces, Nylon-latex knitted braces and Polyester-latex knitted braces, wherein uncompressed neoprene or compressed foam is used as a core. In these products, the core is bonded to fabrics by an adhesive lamination process. The support products, other than neoprene, are two-way stretchable, hence fail to provide relaxation as they cannot provide compression in all directions. The soft-orthopedic supports are often made from neoprene rubber (i.e. polychloroprene). This material is desirable because of its combination of favorable properties useful in orthopedic supports. Neoprene rubber has good elasticity and a relatively high density, properties which combine to provide good compression support and resistance to shear forces. Neoprene based products are preferred, as neoprene based supports are stretchable in four-way. However, the neoprene based products are not air permeable, non-bendable and causes higher perspiration as well as skin irritation to the user thereby causing discomfort to a user.

Thus, there is need of a composite material for orthopedic supports including braces that overcomes the above mentioned drawbacks of the prior art and that provide sufficient elasticity and density to offer a necessary level of compression support and that dissipates heat during use in order to avoid undue perspiration and heat discomfort during prolonged use of the support.

Summary
Disclosed herein is a composite material for orthopedic supports and braces, and a process thereof. The composite material for orthopedic supports comprises a first layer having anti-microbial and moisture management properties being an inner fabric layer in a highly stretchable form, a second layer being an intermediate fabric layer in an uncompressed form, and a third layer being an outer fabric layer, wherein the second layer is sandwiched in an uncompressed form between the first layer and the third layer thereby forming a breathable and four-way stretchable trilaminate material that facilitates therapeutic compression from all the directions on muscle and/or joint of a user.

The first layer is selected from cotton-spandex fabric, cotton, polyester, nylon, polyester-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof. The second layer is an open-celled, stretchable, uncompressed, high density polyether based polyurethane foam, polyester based polyurethane foam or a combination thereof. The third layer is selected from stretchable polyester spandex warp knitted fabric, cotton, polyester, nylon, cotton-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof.

The first layer, the second layer and the third layer fabric structure type is a circular knit, a warp knit, a woven, a non-woven and a combination thereof. The thickness of the first layer and the third layer is in a range from about 0.1mm to about 2mm and the thickness of the second layer is in a range from about 1mm to about 8mm. The density of the second layer is in a range from about 30 to 180 kg/m3.

A process for manufacturing the composite material for orthopedic supports comprises the steps of providing a highly stretchable fabric layer as a first layer;
providing a highly stretchable open-celled high density material as a second layer, providing a highly stretchable fabric layer as a third layer; and flame-laminating the first layer and the third layer on the intermediate layer in an uncompressed form of the intermediate layer in a single pass.

Brief description of the drawing
FIG. 1 shows a cross-sectional view of a composite material for orthopedic supports and braces, in accordance with a preferred embodiment of the present invention.

Detailed description of the invention
Although specific terms are used in the following description for sake of clarity, these terms are intended to refer only to particular structure of the invention selected for illustration in the drawings, and are not intended to define or limit the scope of the invention.

References in the specification to “preferred embodiment” means that a particular feature, structure, characteristic, or function described in detail thereby omitting known constructions and functions for clear description of the present invention.

The present invention is illustrated with reference to the accompanying drawing, throughout which reference numbers indicate corresponding parts in the various figures. These reference numbers are shown in bracket in the following description.

In one aspect, provided herein is a composite material for orthopedic supports and braces, and a process thereof in accordance with a preferred embodiment of the present invention.

In another aspect, provided herein is a process for manufacturing a composite material for orthopedic supports and braces.

In a preferred embodiment, referring to FIG. 1, a composite material for orthopedic supports is disclosed. The composite is a tri-laminate material comprising an inner fabric layer with wicking and anti-microbial properties, an intermediate layer of highly stretchable open-celled high density material in un-compressed form and an outer fabric layer.

The composite material (100) for orthopedic supports including brace in accordance with a preferred embodiment of the present invention is shown. In this preferred embodiment, the composite material (100) comprises of a first layer (20), a second layer (40), and a third layer (60). The first layer is an inner layer. The second layer (40) is an intermediate layer, and the third layer (60) is an outer layer. The first layer is made of highly stretchable cotton-spandex fabric. Advantageously, the inner layer has anti-microbial and wicking properties.

The second layer (40) is defined by an inner surface (30) and an outer surface (35). The inner surface (30) of the second layer (40) is aligned towards the first layer (20) and the outer surface (35) of the second layer (40) is aligned towards the third layer (60). The second layer is made of highly stretchable open-celled un-compressed high density polyether based polyurethane foam. Advantageously, the density is about 120kg/m3. The third layer (60) is adjacently attached to the outer surface (35) of the second layer (40). The third layer (60) is made up of stretchable polyester spandex warp knitted fabric.

In accordance with the preferred embodiment of the present invention, the second layer (40) is sandwiched between the first layer (20) and the third layer (60) and is passed through a flame lamination machine for bonding the fabric material with the second layer (40). The composite material (100) of the present invention is used in a wide variety of orthopedic products such as brace, supports, medical insole and the like that involves direct surface contact between the composite material (100) and skin of a user. The composite material (100) is breathable, non-irritating and four-way stretchable. The composite material is used in orthopedic supports and braces such as knee supports, wrist supports, elbow supports and the like. The composite material is sufficiently elastic and of sufficient density to provide the compression necessary to serve as a useful orthopedic support.

The composite material (100) helps in reducing perspiration thereby providing greater comfort to the user for longer period as it is breathable and inner wicking material. The composite material (100) is four-way stretchable that provides therapeutic compression from all the direction which in-turn provides improved circulation, coordination and muscle and joint stabilization to the user. As un-compressed high density polyether based polyurethane foam is used as the second layer (40), the composite material (100) provides greater stability, stretch-recovery property and compression. As the second layer (40) is bonded to the layers by using the flame lamination process, it avoids skin irritation or allergy while usage.

The first layer (20) acts a moisture management system that provides comfort against perspiration. Further, the first layer (20) has an anti-microbial property that provides protection against microbes and also avoids bad odor by killing harmful bacteria. The composite material (100) being air permeable and stretchable in all directions is a better substitute for neoprene based materials. The composite material (100) does not use adhesive for bonding, thereby providing protection against skin allergy.

In this embodiment, the intermediate layer is polyether based polyurethane foam having density about 120kg/m3, the inner fabric layer is a highly stretchable cotton-spandex fabric, and the outer fabric layer is an highly stretchable polyester-spandex fabric.

In an alternative embodiment, the intermediate layer is selected from the group comprising of polyether based polyurethane foam having density about 120kg/m3; polyester based polyurethane foam and the like. The thickness of the second layer is about 1mm to about 8mm.

In an alternative embodiment, the first layer is selected from the group comprising of a highly stretchable cotton-spandex fabric, cotton, polyester, nylon, polyester-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof. The thickness of the first layer is about 0.1 to about 2mm.

In a further alternative embodiment, the third layer is an highly stretchable fabric selected from the group comprising of polyester-spandex, cotton, polyester, nylon, cotton-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof. The thickness of the outer layer is about 0.1 to about 2mm.

In an alternative embodiment, the type of fabric structure is circular knit, warp knit, woven, non-woven, and the like.

In another embodiment, the present invention provides a process for manufacturing a composite material (100). The process comprises the steps of initially providing a highly stretchable fabric layer as a first layer. Next step involves providing a highly stretchable open-celled high density material as a second layer. Further step includes providing a highly stretchable fabric layer as a third layer. In a next step, the first layer and third layer are flame laminated on the second layer in the uncompressed form of the second layer in a single pass.

The orthopedic supports made from the composite material (100) of the present invention can be used to provide required levels of anatomical compression support. The material also improves air circulation to the supported area sufficient to prevent the discomfort caused by perspiration and over-heating.

Examples

Table 1 by way of an example provides a preferable properties of high density polyether based polyurethane foam composition in accordance to a preferred embodiment of the present invention:

Sr. No. Properties Standards High Density Polyether virgin Polyurethane Foam
1 Density g/cc ASTMD1056 0.126
2 Hardness Asker C ASTMD2240 40-42
3 Tensile Kg/cm2 ASTMD3574 4.5
4 Elongation% ASTMD3574 324
5 Breath abilitycc/sec/cm2 ASTMD 737 25.59
6 Compression Set, % ASTMD1056 --
7 Stretch, %
-Length wise
-Width wise
ASTMD6614
58.47
60.67
8 Recovery, %
-Length wise
-Width wise
ASTMD6614
1.3
1.8

Table 2 by way of an example describes preferable properties of the composite material (100) in accordance with a preferred embodiment of the present invention:
Sr. No. Properties Standards Tri layer composite (Polyester Spandex/PU foam/ Cotton Spandex)
1 Tensile, %
-Length wise
-Width wise
ASTMD5034
61.16
73.52
2 Elongation, %
-Length wise
-Width wise
ASTMD5034
234.1
192.9
3 Breathability
cc/sec/cm2 ASTMD 737 10.28
4 Stretch, %
-Length wise
-Width wise
ASTMD6614
25.8
25.3
5 Recovery, %
-Length wise
-Width wise
ASTMD6614
1.8
1.53
6 Martindale Aberration,
Cycles
ASTMD4966
No yarn breakage
up to 50000 cycles

The embodiments of the invention shown and discussed herein are merely illustrative of modes of application of the present invention. Reference to details in this discussion is not intended to limit the scope of the claims to these details, or to the figures used to illustrate the invention.

It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the scope of the present invention.
,CLAIMS:We Claim:
1. A composite material for orthopedic supports, comprising:
a first layer being an inner fabric layer in a highly stretchable form, the first layer having anti-microbial and moisture management properties;
a second layer being an intermediate fabric layer; and
a third layer being an outer fabric layer, wherein
the second layer is sandwiched in an uncompressed form between the first layer and the third layer thereby forming a breathable and four-way stretchable trilaminate material that facilitates therapeutic compression from all the directions on muscle and/or joint of a user.
2. The composite material as claimed in claim 1, wherein the first layer is selected from cotton-spandex fabric, cotton, polyester, nylon, polyester-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof.
3. The composite material as claimed in claim 1, wherein the second layer is an open-celled, stretchable, high density polyether based polyurethane foam, a polyester based polyurethane foam or a combination thereof.
4. The composite material as claimed in claim 1, wherein the third layer is selected from stretchable polyester spandex warp knitted fabric, cotton, polyester, nylon, cotton-spandex, nylon-spandex, viscose, viscose-polyester, viscose-spandex, and a combination thereof.
5. The composite material as claimed in claim 1, wherein the first layer, the second layer and the third layer fabric structure type is a circular knit, a warp knit, a woven, a non-woven and a combination thereof.
6. The composite material as claimed in claim 1, wherein the thickness of the first layer is in a range from about 0.1mm to about 2mm, thickness of the second layer is in a range from about 1mm to about 8mm, and the thickness of the third layer is in a range from about 0.1mm to about 2mm.
7. The composite material as claimed in claim 3, wherein density of the second layer is in a range from about 30 to 180 kg/m3.
8. A process for manufacturing the composite material for orthopedic supports as claimed in one of the preceding claims 1-7, the process comprising the steps of:
a. providing a highly stretchable fabric layer as a first layer;
b. providing a highly stretchable open-celled high density material as a second layer;
c. providing a highly stretchable fabric layer as a third layer; and
d. flame-laminating the first layer and the third layer on the intermediate layer in the uncompressed form of the intermediate layer in a single pass.
Dated this 31st day of August, 2016
FOR ARVIND LIMITED
By their Agent

(GIRISH VIJAYANAND SHETH) (IN/PA 1022)
KRISHNA & SAURASTRI ASSOCIATES LLP