Orthopedic device

Claim 2

A FORMABLE ORTHOPEDIC DEVICE COMPRISING A PLASTIC SHEET MEMBER HAVING ONE SIDE COVERED WITH AN INSULATING FABRIC LAYER WHICH IS AFFIXED TO SAID PLASTIC SHEET MEMBER, SAID PLASTIC SHEET MEMBER BEING AT LEAST ABOUT 50 MILS THICK, AND HAVING A TENSILE STRENGTH AT YEILD OF BETWEEN 2,000 AND 10,000 PSI, AN ELONGATION AT YIELD OF BETWEEN 3 AND 30%, A FLEXURAL STRENGTH OF BETWEEN 3,000 AND 14,000 PSI, A FLEXURAL MODULUS OF BETWEEN ABOUT 0.5 X 10**5 AND 7 X 10**5 PSI, AND NOTCHED IZOD OF BETWEEN 0.3 AND 30 FOOT POUNDS PER INCH, A ROCKWELL HARDNESS OF BETWEEN 15 ON THE R SCALE AND 55 ON THE D SCALE, AND A VICAT SOFTENING POINT OF BETWEEN 60* AND 80*C, SAID INSULATING FABRIC LAYER BEING AT LEAST ABOUT 10 MLS THICK AND IS A FABRIC COMPRISING FIBERS SELECTED FROM THE GROUP

Claim 3

The orthopedic device of claim 1, wherein said plastic sheet member is between 50 and 120 mils thick and has the tensile strength at yield of between 5,000 and 8,000 psi, an elongation at yield of between about 4 and 8%, a flexural strength of between about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi, a notched Izod of between 0.5 and 15 foot pounds per inch, and a Rockwell of between 90 and 100 R.

Claim 4

The orthopedic device of claim 2, wherein said insulating fabric is between about 10 and 22 mils thick.

Claim 5

The orthopedic device of claim 3, wherein said plastic sheet member is between about 65 and 80 mils thick, and wherein said insulating fabric layer is a woven 50:50 blend of an aramid and a high-temperature cross-linked phenolformaldehyde fiber.

Claim 6

The orthopedic device of claim 3, wherein said plastic sheet member is an impact-modified polyvinyl chloride composition between about 80 and 120 mils thick, and wherein said insulating fabric layer is a woven 50:50 blend of an aramid and a high-temperature cross-linked phenolformaldehyde fiber.

Claim 7

The orthopedic device of claim 1, wherein said plastic sheet member is between about 65 and 80 mils thick, and wherein said insulating fabric layer is a blend of an aramid and a high-temperature cross-linked phenolformaldehyde fiber.

Claim 8

The orthopedic device of claim 1, wherein said plastic sheet member is between about 80 and 120 mils thick, and wherein said insulating fabric layer is a blend of an aramid and a high-temperature cross-linked phenolformaldehyde fiber.

Claim 9

The orthopedic device of claim 1, wherein said device is heated by application of heat to the side of the plastic sheet member not covered with the insulating fabric layer and said plastic sheet member is heated to temperatures of above about 160*F, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 25*F below the temperature of said plastic sheet member.

Claim 10

An orthopedic device comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a fabric layer, both of said fabric layers being bonded to said plastic sheet member; said plastic sheet member being between 50 and 120 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being between about 10 and 22 mils thick; said other fabric layer being about 4 and 22 mils thick and functioning to protect said plastic layer; and said orthopedic device being formable at temperatures above about 130*F.

Claim 11

An orthopedic device comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a fabric layer, both of said fabric layers being bonded to said plastic sheet member; said plastic sheet member being between 50 and 120 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being between about 10 and 22 mils thick; said other fabric layer being about 4 and 22 mils thick and functioning to protect said plastic layer; and said orthopedic device being formable at temperatures above about 130*F.

Claim 12

The orthopedic device of claim 9, wherein said plastic sheet member has a tensile strength at yield of between 2,000 and 10, 000 psi, a notched Izod of between 0.3 and 30 foot pounds per inch, a Rockwell hardness of between 15 on the R scale and 55 on the D scale, and a Vicat softening point of between 60* and 80*C; and said insulating fabric layer has a coefficient of heat transfer below about 2 cal/sec/cm2/cm/*C X 10 4.

Claim 13

The orthopedic device of claim 10, wherein said plastic sheet member has the tensile strength at yield of between 5,000 and 8,000 psi, an elongation at yield of between about 4 and 8%, a flexural strength of bEtween about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi, a notched Izod of between 0.5 and 15 foot pounds per inch, and a Rockwell of between 90 and 100 R; and wherein said insulating fabric layer has a coefficient of heat transfer below about 1.6 cal/sec/cm2/cm/*C X 10 4.

Claim 14

The orthopedic device of claim 11, wherein said other fabric layer is a fabric selected from the group consisting of high temperature stabilized nylons, high temperature stabilized polyesters, and aramids.

Claim 15

The orthopedic device of claim 12 wherein when said device is heated by application of heat to the side opposite that covered by the insulating fabric layer and said plastic sheet member is heated to temperatures above about 160*F, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 35*F below the temperature of said plastic sheet member.

Claim 16

The orthopedic device of claim 12 wherein said insulating fabric layer is a fabric comprising fibers selected from the group consisting of aramid fibers and high temperature cross-linked phenol-formaldehyde fibers.

Claim 17

The orthopedic device of claim 10 wherein said device is heated by application of heat to the side opposite that covered by the insulating fabric layer and said plastic sheet member is heated to temperatures above about 160*F, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 25*F below the temperature of said plastic sheet member.

Claim 18

An orthopedic device comprising a central plastic sheet member having one side covered with an insulating fabric layer and the other side covered with a high temperature knitted fabric comprising fibers selected from stabilized nylon fibers and stabilized polyester fibers, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being between 50 and 120 mils thick, and having a tensile strength at yield of between about 2,000 and 10,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being between about 10 and 22 mils thick; said knitted fabric layer being between about 4 and 22 mils thick and functioning to protect said plastic sheet member; and when said layer device is heated by the application of heat to the knitted side and said plastic sheet member is heated to temperatures above about 300*F, said orthopedic device has thermal characteristics such that it may be shaped and molded for a period of at least about 4 1/2 minutes before it solidifies.

Claim 19

An orthopedic device comprising a central plastic sheet member having one side covered with an insulating fabric layer and the other side covered with a high temperature knitted fabric comprising fibers selected from stabilized nylon fibers and stabilized polyester fibers, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being between 50 and 120 mils thick, and having a tensile strength at yield of between about 2,000 and 10,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being between about 10 and 22 mils thick; said knitted fabric layer being between about 4 and 22 mils thick and functioning to protect said plastic sheet member; and when said layer device is heated by the application of heat to the knitted side and said plastic sheet member is heated to temperatures above about 300*F, said orthopedic device has thermal characteristics such that it may be shaped and molded for a period of at least about 4 1/2 minutes before it solidifies.

Claim 20

The orthopedic device of claim 16, wherein said plastic sheet member is an impact-modified polyvinyl chloride composition and has a tensile strength at yield of between 5, 000 and 8,000 psi, an elongation at yield of between about 4 and 8%, a flexural strength of between about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi , and a notched Izod of between 0.5 and 15 foot pounds per inch; and wherein said insulating fabric layer has a coefficient of heat transfer below about 1.6 cal/sec/cm2/cm/*C10 4; and wherein said orthopedic device has a shaping and molding time of at least about 7 1/2 minutes.

Claim 21

The orthopedic device of claim 17, wherein said insulating fabric layer is a woven 50:50 blend of an aramid and a high temperature cross-linked phenol-formaldehyde fiber.

Claim 22

The orthopedic device of claim 18 wherein when said device is heated by application of heat to the knitted side, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 25*F below the temperature of said plastic sheet member.

Claim 23

The orthopedic device of claim 18 wherein when said device is heated by application of heat to the knitted side, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 40*F below the temperature of said plastic sheet member.

Claim 24

An orthopedic device formable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a stretch fabric which will not tend to distort the plastic sheet member when said device is formed, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick and being substantially thinner than said plastic sheet member; said stretch fabric layer being at least 4 mils thick and functioning to protect said plastic sheet member.

Claim 25

An orthopedic device formable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a stretch fabric which will not tend to distort the plastic sheet member when said device is formed, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick and being substantially thinner than said plastic sheet member; said stretch fabric layer being at least 4 mils thick and functioning to protect said plastic sheet member.

Claim 26

The orthopedic device of claim 21, wherein said plastic sheet member has a tensile strength at yield of between 2,000 and 10,000 psi, an elongation at yield of between about 3 and 30%, a notched Izod of between 0.3 and 30 foot pounds per inch, and a Rockwell hardness of between 15 on the R scale and 55 on the D scale.

Claim 27

The orthopedic device of claim 22, wherein said plastic sheet member has the tensile strength at yield of between 5,000 and 8,000 psi, an elongation at yield of between about 4 and 8%, a flexural strength of between about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi, a notched Izod of between 0.5 and 15 foot pounds per inch, and a Rockwell of between 90 and 100 R; and wherein said insulating fabric layer has a coefficient of heat transfer below about 2 cal/sec/cm2/cm/*C X 10 4.

Claim 28

The orthopedic device of claim 23 wherein said other fabric layer is a fabric comprising fibers selected from the group consisting of high temperature stabilized nylon fibers, and high temperature stabilized polyester fibers.

Claim 29

The orthopedic device of claim 24 wherein said insulated fabric comprises fibers selected from the group consisting of aramid fibers and high temperature cross-linked phenol-formaldehyde fibers.

Claim 30

The orthopedic device of claim 25 wherein said plastic sheet member is a thermoplastic.

Claim 31

An orthopedic device shapeable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a knit fabric which will not tend to distort the plastic sheet member when said device is shaped, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick and is a fabric composed of fibers selected from the group consisting of aramid fibers and high temperature cross-liNked phenol-formaldehyde fibers; said stretch fabric layer being at least about 4 mils thick and functioning to protect said plastic sheet member.

Claim 32

An orthopedic device shapeable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a knit fabric which will not tend to distort the plastic sheet member when said device is shaped, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick and is a fabric composed of fibers selected from the group consisting of aramid fibers and high temperature cross-liNked phenol-formaldehyde fibers; said stretch fabric layer being at least about 4 mils thick and functioning to protect said plastic sheet member.

Claim 33

The orthopedic device of claim 27 wherein said stretch fabric which will not tend to distort the plastic sheet member is a knitted fabric comprising fibers selected from the group consisting of stabilized nylon fibers and stabilized polyester fibers.

Claim 34

The orthopedic device of claim 28, wherein said plastic sheet member has the tensile strength at yield of between 5,000 and 8,000 psi, an elongation at yield of between about 4 and 8% a flexural strength of between about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi, a notched Izod of between 0.5 and 15 foot pounds per inch, and a Rockwell of between 90 and 100 R.

Claim 35

The orthopedic device of claim 29, wherein when said device is heated by application of heat to the side of the plastic sheet member not covered with the insulating fabric layer and said plastic sheet member is heated to temperatures of above about 160*F, the insulating fabric has insulating characteristics such that the temperature of the outside surface of said insulating fabric layer is at least 25*F below the temperature of said plastic sheet member.

Claim 36

An orthopedic device shapeable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a high temperature knitted fabric which will not tend to distort the plastic sheet member when it is shaped, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick; said knitted fabric layer is a fabric composed of fibers selected from the group consisting of stabilized nylon fibers and stabilized polyester fibers and being at least about 4 mils thick and functioning to protect said plastic sheet member; and when said device is heated by the application of heat to the knitted side and said plastic sheet member is heated to temperatures above about 300*F, said orthopedic device has thermal properties such that it may be shaped and molded for a period of at least about 4 1/2 minutes before it solidifies.

Claim 37

An orthopedic device shapeable at elevated temperatures comprising a central plastic sheet member having one side covered with a fabric insulating layer and the other side covered with a high temperature knitted fabric which will not tend to distort the plastic sheet member when it is shaped, said fabric layers being bonded to said plastic sheet member; said plastic sheet member being at least 50 mils thick, and having a tensile strength at yield of above about 2,000 psi, and an elongation at yield of between 3 and 30%, a flexural strength of between 3,000 and 14,000 psi, and a flexural modulus of between about 0.5 X 105 and 7 X 105 psi; said insulating fabric layer being at least about 10 mils thick; said knitted fabric layer is a fabric composed of fibers selected from the group consisting of stabilized nylon fibers and stabilized polyester fibers and being at least about 4 mils thick and functioning to protect said plastic sheet member; and when said device is heated by the application of heat to the knitted side and said plastic sheet member is heated to temperatures above about 300*F, said orthopedic device has thermal properties such that it may be shaped and molded for a period of at least about 4 1/2 minutes before it solidifies.

Claim 38

The orthopedic device of claim 31 wherein said plastic sheet member has a tensile strength at yield of between 5,000 and 8,000 psi, an elongation at yield of between about 4 and 8%, a flexural strength of between about 8,000 and 12,000 psi, a flexural modulus of between about 2 X 105 and 5 X 105 psi, and a notched Izod of between 0.5 and 15 foot pounds per inch.

Claim 39

The orthopedic device of claim 32 wherein said plastic sheet member is an impact modified polyvinyl chloride plastic sheet having a thickness between about 50 and 120 mils.

Claim 40

The orthopedic device of claim 33 wherein said insulating layer is a fabric comprising fibers selected from the group consisting of aramid fibers and high temperature cross-linked phenyl-formaldehyde fibers.

Claim 41

The orthopedic device of claim 34 wherein said insulating fabric layer is a blend of said aramid and said phenyl-formaldehyde fibers.