Patent Application
20190290498
This application relates generally to orthopedic devices and materials for use in orthopedic devices. More specifically, this application relates to orthopedic devices and low-temperature shrinkable materials used in orthopedic devices.
Orthopedic devices are used to describe medical structures such as casts, splints, supports, braces, and other means utilized to support, immobilize, restrain, protect and position body portions. Orthopedic devices are used in many fields, including the physical medicine and rehabilitation field, general medicine, neurological field. Orthopedic devices are also used to prevent recurrence of previous disabilities, and to prevent discomfort and subsequent disability.
Different types of known orthopedic devices have various uses. For example, plaster casts are commonly used for the treatment of fractures. However, plaster casts can take hours to harden, are excessively heavy, commonly have poor compression strength, are readily crushed or broken, and characteristically have poor resistance to water. As another example, ankle injuries are commonly treated with ankle supports in the form of ankle wraps and/or athletic tape. However, wrapping and/or taping ankles is notoriously a slow cumbersome process, expensive, inherently inconsistent, and requires the talent of a skilled person. These are a few of many examples demonstrating the need for orthopedic devices that are practical, suitable for their intended purpose, and capable of being formed in a customizable, generally consistent, convenient, effective, and timely manner.
This application relates to orthopedic devices and low temperature shrinkable materials used in such devices. The low temperature shrinkable materials have a shrink ratio ranging up to about 7:1 at a low temperature ranging from about 100 to about 150° F. Using these lower temperatures to shrink the materials of the orthopedic devices onto the body part of the patient has less risk of injuring the patient than previous materials. The orthopedic devices can contain different sections with higher and lower amounts of the low temperature shrinkable materials.
In some configurations, the orthopedic devices comprise a tubular body forming an interior surface and an exterior surface and including: a leg portion including a first opening; a foot portion connected to said leg portion and including a second opening, said second opening positioned in a back portion of said foot portion and configured to receive a heel of the user; a thickness extending between said interior surface and said exterior surface, said thickness comprising a first thickness in side portions of said tubular body configured to provide lateral support to the ankle and a second thickness in a front portion of said tubular body, said first thickness being greater than said second thickness; and a low temperature shrinkable material having a shrink ratio ranging up to about 7:1 at a temperature ranging from about 100 to about 150 degrees Fahrenheit; where the tubular body moves between a first position, wherein said tubular body is configured to at least partially receive and at least partially surround at least a portion of the ankle, and a second position, wherein one or more portions of at least one of said leg portion or said foot portion are configured to generally conform to and at least partially restrict movement of the at least a portion of the ankle, and wherein said tubular body is configured to move from said first position to said second position when heated at said temperature.
In other configurations, the orthopedic devices comprise a first section containing up to 10 vol % of a low temperature shrinkable material having a shrink ratio ranging up to about 7:1 at a low temperature from about 100 to about 150° F.; a second section containing up to 10 vol % of a low temperature shrinkable material; a middle section between the first and second sections, the middle section configured to strengthen a part of the body needing support and containing a first portion containing more than about 90 vol % of a low temperature shrinkable material; and a second portion containing about 60 to about 90 vol % of a low temperature shrinkable material; wherein the middle section can move between a first position and a second position, the first position configured to partially receive and partially surround that body part and the second position configured to generally conform to and partially restrict movement of that body part, and wherein the middle section is configured to move from the first position to the second position when heated at the low temperature.
In other configurations, the orthopedic devices comprise a first section containing less than about 50 vol % of a low temperature shrinkable material having a shrink ratio ranging up to about 7:1 at a low temperature from about 100 to about 150° F.; a second section larger than the first section, the second section configured to strengthen a part of the body needing support and containing more than about 50 vol % of the low temperature shrinkable material; and wherein the orthopedic device can move between a first position and a second position, the first position configured to partially receive and partially surround that body part and the second position configured to generally conform to and partially restrict movement of that body part, and wherein the orthopedic device is configured to move from the first position to the second position when heated at the low temperature.
The following description can be better understood in light of Figures herein which show various embodiments and configurations of the communication systems. Together with the following description, the Figures demonstrate and explain the principles of the structures, methods, and principles described herein. In the drawings, the thickness and size of components may be exaggerated or otherwise modified for clarity. The same reference numerals in different drawings represent the same element, and thus their descriptions will not be repeated.
In addition, as the terms on, disposed on, attached to, connected to, or coupled to, etc. are used herein, one object (e.g., a material, element, structure, member, etc.) can be on, disposed on, attached to, connected to, or coupled to another object—regardless of whether the one object is directly on, attached, connected, or coupled to the other object or whether there are one or more intervening objects between the one object and the other object. Also, directions (e.g., on top of, below, above, top, bottom, side, up, down, under, over, upper, lower, lateral, orbital, horizontal, etc.), if provided, are relative and provided solely by way of example and for ease of illustration and discussion and not by way of limitation. Where reference is made to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements by itself, any combination of less than all of the listed elements, and/or a combination of all of the listed elements. Furthermore, as used herein, the terms a, an, and one may each be interchangeable with the terms at least one and one or more.
The following description supplies specific details in order to provide a thorough understanding. Nevertheless, the skilled artisan will understand that the described devices can be implemented and used without employing these specific details. Indeed, the described devices and methods can be placed into practice by modifying the described systems and methods and can be used in conjunction with any other apparatus and techniques conventionally used in the industry.
Some embodiments of the orthopedic devices have been described in U.S. Pat. No. 8,979,783 (the '783 Patent), the entire disclosure of which is incorporated herein by reference. The '783 Patent describes some embodiments of orthopedic devices comprising ankle braces, knee braces, and finger braces. As depicted in
Referring now to
In yet other embodiments, the thickness T of the body 102 may vary to influence stiffness and/or flexibility of the ankle brace 100 in different locations. Controlling the flexibility and/or stiffness of the ankle brace 100 in different locations may allow the ankle brace to maintain its structural integrity while providing desired support, protection, positioning, and/or restraint. For example, as shown in
In an embodiment, the liner 130 may be attached to the interior surface 106 of the body 102 along at least a portion of one or more edges of the liner 130. In other embodiments, the liner 130 may be separate from the body 102 and/or the ankle brace 100. For example, the liner 130 may be configured as a protective sock and may be placed on the user prior to placement of the body 102 and/or the ankle brace 100 on the user. In yet other embodiments, the liner 130 may be omitted. The liner 130 may be sized and/or configured to provide a comfortable fit for the user as well as stability. For example, the liner 130 may be comprised of a soft, compressible material such as polyurethane foam, polyethylene foam, microspheres contained in a lubricant matrix, other gels and foams, pneumatics, combinations thereof, or other suitable materials. In other embodiments, the liner 130 may comprise a thermoplastic material that once shrunk, remains relatively flexible and comfortable. Similar to the body 102, the liner 130 may have a thickness that is substantially uniform or varies based on anatomy, desired flexibility, and/or a desired stiffness of the liner 130. The liner 130 may also be sized and/or configured to at least partially protect the user from the treatment. For example, the treatment may comprise a heat treatment and the liner 130 may be configured as a protective layer to generally insulate the user from the heat treatment. In another embodiment, the treatment may comprise a chemical treatment and the liner 130 may be configured to provide an impermeable barrier to substantially protect the user from the chemical treatment.
The intermediate layer 132 may be interposed between the interior surface 106 of the body 102 and the liner 130. Similar to the liner 130, the intermediate layer 132 may be sized and/or configured to provide a comfortable fit, stability, and/or protection to a user from the treatment. For example, the intermediate layer 132 may have a thickness preconfigured to provide a physical barrier between the user and the treatment. In another embodiment, the intermediate layer 132 may comprise one or more insulation materials configured to at least partially protect the user from a treatment comprising a heat treatment. For example, the intermediate layer 132 may comprise polyurethane, elastomeric foam, mineral wool, phenolic foam, polystyrene, combinations thereof, of any other suitable insulation materials. In yet other embodiments, the intermediate layer 132 may be configured to dissipate heat before heat from a heat treatment reaches the liner 130 and/or the user. For example, the intermediate layer 132 may comprise water, air, gels, combinations, thereof, or any suitable heat dissipating material. Moreover, similar to the body 102, the thickness of the intermediate layer 132 may be substantially uniform or may vary based on anatomy, desired flexibility, and/or a desired stiffness of the liner 130.
The ankle brace 100 contains one or more features configured to selectively move the ankle brace 100 between a receiving position, wherein the ankle brace 100 may receive and/or generally surround the leg, the ankle, and/or the foot, and a supporting position, wherein one or more portions of the ankle brace 100 substantially conforms to and/or at least partially restrict movement of the ankle in one or more directions. For example, the body 102 may be made from a variety of different shrinkable materials that are configured to shrink the ankle brace 100 into the receiving position in response to a treatment. Shrinkable materials are materials capable of being reduced in size in response to a treatment. Specifically, the tubular body 102 may comprise one or more thermoplastic materials, polyolefin, polyolefin elastomer, nylon, neoprene, silicone rubber, woven fabric, combinations thereof, or other suitable shrinkable materials. In an embodiment, the shrinkable materials may be uniform throughout the body 102. In other embodiments, the shrinkable materials may vary at different locations on the body 102. For example, the first side portion 120 and the second side portion 122 in the area of the user's ankle may comprise a shrink material that in the supporting position becomes generally stiff or rigid to at least partially restrict abnormal eversion and/or inversion of the ankle. In addition, the front portion 116 in the area of a user's lower leg portion may comprise a shrink material that in the supporting position remains generally flexible to generally allow dorsiflexion and/or plantar flexion. This patent described similar braces that could be configured for the knee, finger, or other parts of the body that needed to be supported.
As described in the '783 Patent, the braces contain shrinkable materials that may be configured to control the shrinkage of portions of the brace. The selected portions of the brace could be shrunk by a treatment process, including a heat treatment process using a shrink temperature. The shrink temperature is the minimum temperature at which a shrinkable material shrinks. Unfortunately, many materials that were used in the heat treatment process of the '783 Patent had a high shrinkage temperature that can injure the user (i.e., the patient) or even the medical personnel placing the device on the patient.
Accordingly, in some embodiments, the ankle brace can contain materials with a low shrink temperature. In these embodiments, the shrink temperature can be the same or lower than the shrink temperature of the materials described in the '783 Patent. Accordingly, in some embodiments the shrink temperature can range from about 100 to about 150 degrees Fahrenheit. In yet other embodiments, the shrink temperature can range from about 110 to about 130 degrees Fahrenheit. In yet other embodiments, the shrink temperature can be any combination or sub-range of these degrees.
The low temperature shrinkable materials may be configured to control the amount of shrinkage of the ankle brace 100. For example, they may have a shrink ratio between about 7:1 to 1.1:1; 6:1 to 1.3:1; 5:1 to 1.5:1; or even 4:1 to 2:1. The shrink ratio is the quantitative relation between the initial size of the body 102 and the shrunken size of the body 102. In yet other embodiments, the shrink ratio can be any combination or sub-range of these ratios. In other embodiments, including those described below, the ankle brace 100 may include shrinkable materials having different shrink ratios in different locations on the ankle brace 100.
In these embodiments, these materials also exhibit other features that can be useful for the brace. One of these features is their strength. In some embodiments, the tensile strength of the materials can range from about 100 to about 200 MPa as measured by the D2256 ASTM method. In other embodiments, the tensile strength of the materials can be about 145 MPa. As well, in some embodiments, the break strength of the materials can range from about 2 to about 20 lbs. as measured by the D2256 ASTM method. In other embodiments, the break strength of the material can be about 4.3 lbs. In yet other embodiments, the material strength can be any combination or sub-range of these amounts.
Another feature that can be useful for the braces is the density of the material. In some embodiments, the materials can have a density of about 200 deniers or less. In other embodiments, the materials have a density ranging from about 150 deniers to about 200 deniers.
In some embodiments, these materials can comprise any thermoplastics material such as PET (polyethylene terephthalate), PP (polypropylene), PLA (polylactic acid), or combinations of these materials. In other embodiments, these materials can include amorphous PLA, crystalline PLA, or combinations thereof. The materials may comprise un-oriented yarns, partially oriented yarns, fully oriented yarns, or combinations thereof. These yarns can be woven or knit into the desired configuration and, therefore, are different than the materials described in the '783 Patent which are formed (i.e., extruded) as a continuous sheet. These materials are also stronger as a result of the weave or knit pattern.
Other configurations can be used for the braces. For example, these materials may allow an ankle brace 100 to be customized and/or conformed to a specific user in a minimal amount of time. As well, less materials need be used in the brace to provide the needed support to the desired portion of the patient's body, as shown in
In
In
The braces 200 shown in
In
The top and bottom portions of the brace are made of a minimal amount of the low temperature shrinkable materials. In some configurations, the top and bottom portions contain anywhere from 0 to about 10 vol % of the low temperature shrinkable materials. The top and bottom portions provide less of a support function than the middle portion. Therefore, they need to shrink less than the middle portion and only need to contain a small amount of the low temperature shrinkable materials.
The middle portion 630 of the brace 600 provides most of the support function and therefore needs to have a higher concentration of the low temperature shrinkable materials. But it does not need to contain a homogenous concentration of the low temperature shrinkable materials since some parts of the middle portion provide a higher concentration than other parts. So those parts of the middle portion that provide more support function contain a higher amount of the low temperature shrinkable material.
In the configurations shown in
Although the orthopedic devices and systems described above have been discussed in the context of ankle braces. In other embodiments, the orthopedic devices and systems disclosed herein are not limited to such use and may be used for many different applications, if desired, without limitation as described in the '783 Patent. Thus, such orthopedic devices and systems are not limited for use with ankle braces and may be used with various other braces and supports, without limitation. Indeed, the orthopedic devices and systems described above are not limited to being used on human patients, but also on animals. As well, while the low temperature shrinkable materials are described with reference to
In addition to any previously indicated modification, numerous other variations and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of this description, and appended claims are intended to cover such modifications and arrangements. Thus, while the information has been described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred aspects, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, form, function, manner of operation and use may be made without departing from the principles and concepts set forth herein. Also, as used herein, the examples and embodiments, in all respects, are meant to be illustrative only and should not be construed to be limiting in any manner.
