Orthopedic system for immobilizing and supporting body parts

Abstract

A unitized cast system for immobilizing and supporting a body part. The unitized casting system includes a first inner layer for padding and dissipating heat against the patient's skin. A second layer is formed from a thermoformable structural material such as perforated plastic. A protective third outer layer is provided to provide insulation for the second layer. These three layers are formed together to form a unitized cast system that is easily formed and applied to the patient.

Claims

1. A cast system for supporting a body part, said cast system comprising: an inner layer for providing insulation and cushioning against the body part, said inner layer formed of flexible foam and having a first density; a middle layer malleable for a dwell time when heated to conform about a body part and that provides rigid support for the body part when said middle layer is at room temperature, said middle layer having a second density; an outer layer for providing insulation for said middle layer, said outer layer formed of flexible foam and having a third density; and said inner layer, said middle layer, and said outer layer are assembled together to form a unitized cast, with an edge of said middle layer recessed from corresponding edges of said inner layer and said outer layer, and with said edges of said inner layer and said outer layer sealed together encapsulating said middle layer, wherein said first and third densities being less than the second density of the middle layer increases the dwell time of said middle layer, and wherein the encapsulation of the middle layer by the inner layer and the outer layer increases the dwell time of the middle layer.

2. The cast system of claim 1, wherein said inner layer and said outer layer insulate said middle layer to maintain said middle layer at a temperature at which said middle layer is malleable for a time period sufficient to allow said middle layer to be formed about the body part.

3. The cast system of claim 1, wherein said inner layer and said outer layer insulate and dissipate heat of said middle layer, thereby allowing, in use, said layers to be heated up to 250 Fahrenheit without causing discomfort to the body part during subsequent forming on the body.

4. The cast system of claim 1, further including perforations in said middle layer, wherein the perforations remove twenty to sixty percent of said middle layer to allow said middle layer to better conform to the body part and be malleable at lower temperatures.

5. The cast system of claim 1, wherein said middle layer is formed of a rigid foam material having thirty to fifty percent air bubbles in said middle layer to allow said middle layer to better conform to the body part and be malleable at lower temperatures.

6. The cast system of claim 1, wherein said middle layer is formed of a heat formable material that is selected from the group consisting of: Amorphous Polyethylene Terephthalate, Recycled Polyethylene Terephalate, Polyvinyl Chloride (PVC), PVC foam, polycaprolactone, caprilactone, Polyethylene and derivates of those materials.

7. The cast system of claim 1, wherein said middle layer is formed of a material that is heat formable at a temperature of about 250 degrees Fahrenheit or below.

8. The cast system of claim 1, wherein said middle layer is formed of a material that is heat formable at a temperature of about 250 degrees Fahrenheit or below for a time sufficient to allow said cast system to be formed to closely fit on the body part.

9. The cast system of claim 1, wherein said middle layer includes: multiple layers of materials that are heat formable to form about the body part while supporting the body part when said materials are cool.

10. The cast system of claim 1, wherein said middle layer is formed with varying thicknesses through said middle layer to provide greater rigidity at thicker areas of said middle layer and greater flexibility at thinner areas of said middle layer.

11. The cast system of claim 1, wherein said middle layer is formed of a material that is heat formable at a temperature of about 250 degrees Fahrenheit or below for a dwell time sufficient to allow said cast system to be formed to closely fit on the body part, and wherein said dwell time is controlled by selecting from the group consisting of the material choice, density of the material, the thickness of the material and the insulation properties of the inner layer and the outer layer and combinations thereof.

12. The cast system of claim 1 further including at least one additional layer adjacent to said inner layer to provide additional comfort to the body part.

13. The cast system of claim 1, wherein the inner layer is treated with a medicine or an anti-microbial.

14. The cast system of claim 1 further including at least one additional layer adjacent to said outer layer to provide durability and aesthetics to said cast system.

15. The cast system of claim 1, wherein the inner layer is configured to accept and dispense therapeutic chemical additives.

16. The cast system of claim 1 further including at least one ventilation hole formed through said cast system for providing ventilation to the body part through said cast system.

17. The cast system of claim 1, wherein said outer layer includes a polymer foam layer that is moldable at temperatures above 250 degrees Fahrenheit so that features molded in said polymer foam layer are retained as said cast is heat formed about the body part.

18. The cast system of claim 1, wherein said inner layer, said middle layer, and said outer layer are assembled and molded together to form a unitized cast.

19. The cast system of claim 1, wherein said inner layer, said middle layer, and said outer layer are assembled and compression molded together to form a unitized cast.

20. The cast system of claim 1, wherein said inner layer, said middle layer, and said outer layer are laminated together to form a unitized cast.

21. The cast system of claim 1, further including an attachment mechanism assembled on said cast system for securing said cast system around the body part.

22. The cast system of claim 1, further including an attachment mechanism that allows the side edges of said laminated layers to overlap one another from ten to twenty-five percent of the circumference of said casting system to allow said casting system to accommodate different sizes of body parts.

23. The cast system of claim 1, further an attachment mechanism that allows the side edges of said laminated layers to overlap one another from ten to twenty-five percent of the circumference of said casting system to allow said casting system to be adjustable around the body part.

24. The cast system of claim 1 further including a closure system that mechanically allows a doctor or technician to set said closure system on said cast system; and a doctor or technician's tool for setting said closure system of said cast system.

25. The cast system of claim 1 further including a dry heat source for heating said cast system for shaping around the body part.

26. A cast system that is formable about a body part to support the body part, the cast system comprising: a material having a first density that is rigid at temperatures below about 140 degrees Fahrenheit and is heat malleable at a temperature of about 200 degrees Fahrenheit for a dwell time sufficient to allow said cast system to be formed to fit on the body part wherein said dwell time is controlled by selecting from the group consisting of the material choice, density of the material, the thickness of the material and the insulation properties of an inner layer and an outer layer and combinations thereof, said material is assembled with said inner and said outer layer into a unitized cast, with an edge of said middle layer recessed from corresponding edges of said inner and outer layers, and with said edges of said inner and outer layers sealed together encapsulating said middle layer; and said inner layer having a second density less than said first density, said outer layer having a third density less than said first density, and said dwell time is increased by said second and third densities being less than said first density and by said sealed edges of said inner and outer layers encapsulating said middle layer.

27. A cast system that is formable about a body part to support the body part, the cast system comprising: a multi density single material that includes a center portion and two outer portions, said center portion having a higher density than said two outer portions and that is rigid at temperatures below about 140 degrees Fahrenheit and is heat malleable at a temperature of about 200 degrees Fahrenheit, where said two outer portions have a lower density to provide insulation and cushioning around said center portion and to insulate said center portion for a dwell time sufficient to allow said heated cast system to be formed to the body part, wherein said material is configured for assembly into a unitized cast.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is top view of a unitized casting system of a preferred embodiment of the present invention.

(2) FIG. 2 is a disassembled view of the layers of the embodiment of FIG. 1.

(3) FIG. 3 is a detail view of the disassembled view of the layers of the embodiment of FIG. 1.

(4) FIG. 4 is a detailed view of the assembled embodiment of the embodiment of FIG. 1.

(5) FIG. 5 is another view of the assembled embodiment of the embodiment of FIG. 1.

(6) FIG. 6 is a side view of the embodiment of FIG. 1 being mounted onto a wrist.

(7) FIG. 7 is a side view of the unitized cast of the embodiment of Figure mounted onto a wrist after compression forming.

(8) FIG. 8 is a cross sectional view of the unitized cast that is laminated.

(9) FIG. 9 is a cross sectional view of the unitized cast that is laminated with the edges molded.

(10) FIG. 10 is a cross sectional view of the unitized cast that is molded with heat and spot adhesive.

(11) FIG. 11 is another preferred embodiment using a single material layer having a higher density inner portion and a lower density on the outer surfaces.

(12) FIG. 12 is a view of a side view of the cast applied to the wrist of a patient.

(13) FIG. 13 is view of another alternative securing mechanism of the cast system of FIG. 1.

(14) FIG. 14 is view of another alternative securing mechanism of the cast system of FIG. 1.

(15) FIG. 15 is a view of a securing mechanism of the cast system.

(16) FIG. 16 is a cross-section view of the cast system of the embodiment of FIG. 15.

(17) FIG. 17 is a perspective view of the cast system undergoing compression for shaping about the patients' wrist.

(18) FIG. 18 is a perspective view of the cast system undergoing compression for shaping with a compression tube.

(19) FIG. 19 is a perspective view of a neck cast using the preferred embodiment of the invention.

(20) FIG. 20 is a perspective view of the neck cast of FIG. 19 with an alternative securing mechanism.

(21) FIG. 21 is a perspective view of a foot cast using the preferred embodiment of the invention.

(22) FIG. 22 is a perspective view of the foot cast of FIG. 21 with an alternative securing mechanism.

(23) FIG. 23 is a side view of the heated cast being placed about a patient's wrist.

(24) FIG. 24 is a view of the heated cast secured on the patient's wrist before compression molding.

(25) FIG. 25 is a perspective view of the cast system cooled and secured about the patient's wrist.

(26) FIG. 26 is a perspective view of the dry heat pouch of a preferred embodiment of the present invention.

(27) FIG. 27 is a cross-section view of the dry heat pouch of the embodiment of FIG. 18.

(28) FIG. 28 is a perspective view of an exothermic heat pouch of a preferred embodiment of the present invention.

(29) FIG. 29 is a perspective view of a dry heat oven of a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

(30) A preferred embodiment of the present invention is illustrated in FIGS. 1-29. It is to be expressly understood that the descriptive embodiments are provided herein for explanatory purposes only and are not meant to unduly limit the claimed inventions. The exemplary embodiments describe the present invention in terms of cast systems used for immobilizing and supporting body part as shown in FIGS. 1-29. It is to be understood that the present invention is intended for use with other types of medical, sports, veterinary and other types of uses.

(31) Overview

(32) The system, in a preferred embodiment, provides a unitized casting system that is far superior to previous systems. The system of a preferred embodiment of the present invention, as used as a cast, is shown in FIGS. 1-6. This cast system is illustrated as a wrist cast but it is to be expressly understood that it can be used for any type of casting situation, such as but not limited to foot casts, neck casts, leg casts, arm casts etc. This cast system 10 of this embodiment includes an outer durable padding layer 20, a mid support layer 30 and an inner comfort padding layer 40 as shown in FIG. 2. The three layers each provide unique functions and when combined into a unitized cast create a unique and superior cast. The three layers, each described in greater detail below, are molded or laminated together to form a unitized cast. Closures 50 are applied prior to use that enable a health care provider without specialized training to easily form the cast in an appropriate shape and secure the cast to the patient. The resulting cast is much more comfortable for the patient and can increase the patient's compliance with its use. The resulting cast has many additional benefits over the previous systems as discussed above and below.

(33) The unitized system of this preferred embodiment enables the cast to be pre-laminated, pre-shaped or in blank sheets and provided in sizes according to a desired use, such as for supporting a wrist, arm, knee, neck or other body location. The system is then easily customized to the particular patient as discussed below. The system, in a preferred embodiment, also allows the cast to adjust as necessary by the patient to accommodate swelling or other issues. This adjustability also allows the cast to be customized to the particular body part being supported.

(34) The casting system is heated with dry heat to become thermoformable for shaping within a few minutes. The casting system at temperatures between 160 degrees Fahrenheit to 250 degrees Fahrenheit (the Target Temperature) is pliable for ease in shaping but still is able to maintain some degree of stiffness so not to be overly fluid that is reach beyond the glass transition temperature of the material. The system can then be placed on the patient without burning or causing discomfort to the patient during this process. The relatively low density foam inner layer insulates the high density hot middle plastic layer from the body. The skin, having a higher density than the foam, actually cools the foam more rapidly than the foam can transfer heat to the skin thus protecting it from burning at the temperatures used. The system is then formed to the exact shape desired for that particular patient easily and without the need of specialized skill using a method described below.

(35) The system of a preferred embodiment is designed to allow the time during which the casting system is malleable to be controlled. This is referred to herein as the dwell time for the cast. This is a critical time in that it is the time that physician or technician has to precisely mold the cast onto the patient's body. This preferred embodiment controls the dwell time by the selection of the middle layer material, the density/thickness of the middle layer material, the temperature range at which the middle material is malleable and the insulative qualities of the inner and outer layers. In addition, dwell time can be adjusted by the user depending on the temperature the item is heated to, higher temperatures resulting in longer dwell times.

(36) The unitized casting system of this preferred embodiment includes a soft inner foam layer 40 assembled by laminating or molding or other manufacturing processes to the mid support layer 30. The inner foam layer 40 provides comfort next to the skin. It can protect the patient's skin from abrasion and heat from the mid layer 30 as well as being water proof (non absorbent). This layer may be formable at the Target Temperatures to provide a precise fit to the smallest details of the patient. The particular foam composition for this layer is low density as discussed above to dissipate heat so the patient is not harmed when the warm cast is initially placed around the body part. In other preferred embodiments, the foam may not be malleable but is able to compress to comfortably fit closely around the body part of the patient. The foam provides cushioning as well to increase the comfort and compliance of use. The foam in the preferred embodiment is of a closed cell construction though alternatives may be open cell to provide breath-ability if waterproof features are not desired. This layer may also be of a foam formulation to accept and dispense therapeutic chemical additives such as antimicrobials, skin lotions or other medicines and chemicals. In addition, visco-elastic memory foam may be used for this layer to conform precisely to the body.

(37) This inner layer 40 in the preferred embodiment is formed from a foam material, such as from a variety of cross-linked Polyethylene (PE) and Ethylene Vinyl Acetate (EVA) foams or other suitable materials. The material of the inner layer is moldable at the Target Temperatures. However, this layer may also be moldable at higher temperatures about 300 degrees Fahrenheit which are achieved in the manufacturing process. This allows the material to be compression molded into various forms during manufacturing and for the edges to be heat sealed closed to the outer layer thus encapsulating the mid layer. This layer can be treated with various medicines or antimicrobial treatments.

(38) An additional layer may also be molded inside of the inner layer to provide anti-microbial features. Other therapeutic properties may be incorporated as well into these additional layers. This layer could be foam, fabric, non-woven fabric or other suitable material.

(39) The middle layer 30 of this preferred embodiment is a thin thermoformable polymer plastic material that becomes pliable at the Target Temperature yet substantially rigid at room temperature. This layer provides a substantial amount of support for the body part. It may be engineered to have varying degrees of flexibility and rigidity as desired by varying the polymer material composition. The features may also be varied by the material thickness or by perforations or cut-outs. This layer may be molded with varied thicknesses, tapered edges, ribbing, holes and features that provide the desired rigidity, strength and flexibility required for the intended healing purpose.

(40) The middle layer 30 of the preferred embodiment is preferably formed from Polyvinyl Chloride (PVC) sheet, Amorphous Polyethylene Terephthalate (APET), Recycled Polyethylene Terephalate (RPET) or PVC foam such as Sintra, or Komatex.

(41) Other preferred materials include without limitation polycaprolactone, and caprilactone. Also such materials as Low or High Density Polyethylene (HDPE) and similar materials may be used as well. Additional materials that are thermoformable at temperatures below 250 degrees Fahrenheit while rigid at room temperatures may be used as well.

(42) One key feature to making this layer easily conformable to the three dimensional surfaces of the body is to perforate it with small holes 32 close together resulting in an open structure from 25% to 50% open. This method creates a matrix framework around the holes that, when heated and pliable, can more easily form by deforming around the small holes 32, moving into the small holes 32 or stretching the small holes 32 apart. With this perforation method, thicker stiffer materials can be used than would not normally be adequately formable without the perforations. Perforating also allows the plastic polymer to be formed at lower temperatures than a continuous layer due to deforming process mentioned above which is important for patient comfort and safety. The thick matrix framework when cool and formed in a cylindrical fashion becomes very rigid as needed for the most supportive casts. In addition, weight is reduced by the perforations which increase the comfort and compliance of the patient. These perforations to the middle layer are separate from the ventilation holes that are used for ventilation and cooling purposes which must be punched through all of the layers and are intended to be larger and further apart. In a preferred embodiment of the present invention, the perforations remove between twenty-five to sixty percent of the weight of the middle layer. These perforations are particularly useful when the material for the middle layer includes PVC sheet, APET and RPET.

(43) Alternatively, foam materials, such as PVC foam (including Sintra and Komatex) and APET may be foamed when extruded or molded with 20 to 50 percent air or gas bubbles instead of perforations. Other foamed materials may be used such as rigid EVA foams and other high density foamed polymers. Their use depends on the desired rigidity and durability required for each use.

(44) The middle layer 30 may have a varying topography such as by having increased thicknesses in areas where additional rigidity is desired and decreased thicknesses in areas where more flexibility is needed.

(45) The middle layer 30 may also include multiple layers of heat formable material. These different materials may include different characteristics of rigidity and heat formability, or they may only be on certain areas of the middle layer to increase rigidity or flexibility at certain areas of the middle layer. Also, additional materials may be inserted in the middle layer at desired locations to provide additional rigidity or flexibility as needed.

(46) The outer layer 20 is another foam layer that, in a preferred embodiment, has many of the features of the inner layer including providing insulation against the heat of the middle layer when forming the cast about a body part. Additionally it provides aesthetics to the cast and also provides protection from abrasion from the middle layer. It is intended to provide a durable and comfortable covering to the rigid and perhaps rough perforated middle layer. In a preferred embodiment, the outer layer is formed from a foam, such as urethane foam, foam rubber or EVA foam that is moldable at a temperature above the Target Temperatures. This allows the outer layer to be thermoformed during manufacturing with relief features, ribs, depressions or cosmetic shapes and to have the edges sealed to the inner layer at temperatures considerably higher than the Target Temperatures. Such features would not be affected during the patient forming process. The outer layer, in the preferred embodiment, does not thermoform at the Target Temperature, but will stretch to follow the shape of the mid layer. Since it does not thermoform, it will not pick up the imprint of the elastic wrap or compression tube and will remain smooth and attractive in appearance. It can be thermoformable at the Target Temperature if these features are not desired.

(47) The outer foam layer may also be of a stiff foam to provide additional support, as well as environmental protection, aesthetics and also to provide some support during the thermoforming process. When comparing this outer layer with the typical abrasive plaster or fiberglass cast outer surface, significant improvements in comfort, appearance, aesthetics, durability and ease of use can be experienced. Also, fabric, synthetic leather or other cosmetic covering may be laminated to the outside of this layer for purposes of aesthetics or durability. In addition, fabric can be applied known as unbroken loop which has a surface compatible with common hook and loop fasteners such as Velcro. This allows closures, extra supports, multi-part casts and other devices to be instantly connected using common hook strip fasteners.

(48) The cast may perforated through the three layers to form ventilation holes 12 in various amounts and shapes to provide ventilation, forming features, access to wounds or access to catheters etc. These apertures also allow the middle layer to expand and shrink as necessary as the cast is being molded to the body part. The unitized cast may also be perforated to create apertures 14 for body parts such as thumbs, toes, etc. It may also be perforated to accept various closure system attachments. In most cases, the preferred embodiment is wrapped once around the extremity and overlapped to some degree. This is to accommodate the varied body diameters and shapes encountered within each sized product and is a feature not found with typical plaster and fiberglass casts. The overlap is also the spot where the closure devices will be placed that allow the cast to be opened or closed in circumference during use.

(49) The middle layer 30 is sandwiched between the inner layers 40 and outer layer 20 and recessed from the edges of those layers during the molding process. In this process, the layers are all heated above the Target Temperature for manufacturing. The mold includes a cut-off line on its outer edge to cut the foam of the inner layer 40 and outer layer 20 as well as any fabric layers. In addition, next to the cut-off line a bar compresses the layers to a high degree. The edges of those layers are pinched to seal the edges of the cast 10 tightly closed permanently bonding all layers in the molding process. This provides a clean, soft, rounded thin edge to the cast that is durable, comfortable and less prone to abrade the skin which is a common problem with traditional plaster and fiberglass casts.

(50) Alternatively, the edges may be sealed with an edge tape on the exposed edges. This allows the cast to be formed in blank sheets and custom cut for a particular purpose. The edge tape seals the exposed edges and also forms a soft edge. This tape can be of a flexible thin fabric or foam with an adhesive backing that is easily applied by hand to edges of the cast where desired.

(51) The assembly process of the preferred embodiment uses molding, laminating or any other manufacturing process to form the multiple layers in a single unitized cast. One such process is compression molding which typically includes the following steps:

(52) Laminating of fabrics and coverings to the foam layers.

(53) Die-cutting blanks of each layer.

(54) The plastic sheet mid layer will be die cut and may have fasteners and other features attached. It gets put inside the layers and is set back from the edges.

(55) Heating the foam and fabric layers to the critical molding temperature, above the Target Temperature range where they will be permanently formable.

(56) Placing them into a compression mold that also cuts features (vent and closure attachment holes) and the perimeter while sealing the edges with a compression bar.

(57) The cold metal, wood or plastic mold is compressed and forms the relief patterns in all of the layers as well as punches holes and seals the edge perimeter.

(58) The foam cools by the mold and holds its shape.

(59) All of this must be done at a molding temperature and adhesive temperature so that when the product is reheated to the Target Temperature, it remains intact and the relief patterns do not balloon back out to flat.

(60) An alternative is to use a hot mold that forms the layers by heating them under high compression which are then cooled after forming.

(61) This embodiment does not require lamination as the parts are molded together. However, this embodiment may also include the layers 20, 30 and 40 laminated together as shown in FIGS. 6 and 7. The outer layers extend beyond the middle layer to form a soft edge. The edges of the outer layers may be laminated as shown in FIG. 8, laminated and molded as shown in FIG. 9 or molded with heat sealed edges and spot adhesive as shown in FIG. 10.

(62) A critical feature provided by a preferred embodiment of the present invention is the ability to control the dwell time of the middle layer. The dwell time is the time that the middle layer is formable, before it begins to cool beyond its malleability temperature. This is the time that the physician or casting technician has to properly form the cast onto the body part. In this preferred embodiment, the dwell time is controlled by the initial temperature that the middle layer is heated, by the material choice for the middle layer, by the thickness and perforations or foaming (density) of the middle layer, and by the insulative characteristics of the inner and outer layer. This preferred embodiment uses materials for the rigid middle layer that become malleable at temperatures at or below 250 degrees Fahrenheit. The forming temperature range of these materials by themselves would not normally enable the material to be malleable for a sufficient time and would cause severe discomfort or injury to the patient. These materials by themselves would cool in a matter of seconds when removed from the heat source. The encapsulation in the low density insulating foam inner and outer layers is an important innovation that increases the dwell time and allows it to be varied by the above means while at the same time, insulating the patient for the dangerous heat of the inner layer. The ratio of the perforations in the middle layer is also selected so that the middle layer has sufficient density to retain the heat and to maintain rigidity while being more easily formed due to the perforations.

(63) In another preferred embodiment of the present invention, the entire cast system is formed from a single material and behaves in much the same manner as described for the multi layer cast above. This material as shown in FIG. 11 would have strata that are more and less dense by incorporating more or less gas bubbles into a foam material. The center portion of the material has a higher density (less or no gas bubbles) than the outer portions of the material (more gas bubbles). This can be accomplished by using a foam extruded material where the foam is crushed or manipulated during the manufacturing process so it becomes more dense. It is then processed with heat or other means so the surface lofts and the gas bubbles expand and becomes less dense and more cushioned. This could also be achieved by co-extruding or co-molding multiple layers at the same time which could be foamed to different densities or using different compositions of materials co-extruded. The net effect is a single material sheet with a stiff center portion and cushioning, insulating outer portions. The lower density (more foamed) outer portions of the material can then insulate the inner portion during the forming process about the body part protecting it from discomfort from the heat of the inner portion. This insulation also provides sufficient dwell time for the cast to be formed about the body part extending the time the center portion is pliable. Additional layers can be added as well to provide additional therapeutic and aesthetic benefits.

(64) A fastening system 50 is used to secure the cast closed about the body part as shown in FIGS. 12-15 and to allow some degree of compression to hold the injury in reduction. This system may be double sided adhesive tape placed in between the overlap, adhesive tape applied to the seam or circumferentially, or a mechanical closure system. These mechanical closures may consist of, but are not limited to, hook and loop fastener, snaps, laces, toothed zip ties, ratchet lace systems, ski boot type buckles and the like. In a preferred embodiment, the closure system can be fastened and the tension adjusted by the attending doctor or technician as the cast is applied with a tamper proof closure so it cannot be adjusted by the patient. It can be later re-adjusted by the attending doctor or technician by means of a tool to access the tamper proof adjustable closure. If desired by the attending doctor or technician, the closure could be set so the patient has the means to only loosen or tighten the cast a limited amount but it cannot be prematurely removed. This allows the patient to loosen the cast if there is discomfort or swelling and tighten it if too loose without going back to the physician. In addition, the system could be set by the attending doctor or technician so the patient has the ability to adjust and completely remove the cast. This can extend the life of the cast so it can be used as a temporary brace to protect the partially healed injury during rigorous use. Using this controllable and adjustable system, the attending doctor or technician has options appropriate for all phases of healing and can enable or lock out the patients' ability to make adjustments.

(65) One attachment mechanism in particular includes a tensioning cable system 70 as shown in FIG. 13. The system 70 utilizes a series of guide members 72 on opposite sides of the cast system 10. Lace 74 is laced through guide members 72 on alternate sides as shown in FIG. 13 and then through locking member 76. The lace is drawn tight so the cast has the appropriate tension on the body part and locked into place. An alternative lacing system shown in FIG. 14 is similar to the above mechanism but utilizes a reel mechanism 78 to mechanically tighten and lock the tightened lace that can be easily released and tightened with micro adjustments. These systems can have features mentioned in the above paragraph regarding the attending doctor or technician's ability to lock out patient access to adjustment or allow varied degrees of adjustability built into the mechanism. Another type of securing system includes the use of straps as shown in FIG. 15.

(66) The securing mechanism 50 of the casting system 10 of a preferred embodiment allows the edges of the casting system to overlap. This overlap amounts to about twenty-five percent (25%) of the circumference or less. The closure system discussed above is mounted on this overlap. This increases the adjustability of the casting system to increase or decrease the compressibility on the injured body part. The unitized casting system 10 may be provided in various sizes to fit different body parts and sizes of body parts. The adjustable overlap 80, as shown in FIG. 16 of the unitized casting system of this preferred embodiment provides further capability to custom fit the cast to a particular body part of a particular patient. The securing mechanism 50 allows the cast to be adjusted by increasing or decreasing the amount of the overlap to more closely fit the patient's body part.

(67) The cast, when warm, soft and pliable must be formed to the intimate shapes of the body to best stabilize the injury under reduction. A loose fitting cast with voids between the body and cast can allow undesired movement. A perfectly formed cast that meets every detail of the body can provide stabilization without being excessively tight and in many cases, just meeting the body without compressive force. This is the most comfortable configuration that will provide the needed support yet not constrict, reduce circulation or irritate. In order to achieve this desired effect, a unique method of forming this cast to the body must be incorporated. Since the overlap opening 80 as shown in FIG. 9 that is formed from side edges 16, 18 of the cast is adjustable in circumference, this cast is best formed when warm and pliable by applying compressive circumferential force in excess of the comfortable level for long term wear. Once the cast is cool and rigid in a few moments, this compression can be removed and the closures can be adjusted to provide the desired amount of closure of the cast for comfort and stabilization.

(68) The preferred method of compression identifies two options. An elastic band as shown in FIG. 17 can be quickly wrapped around the warm pliable cast as soon as it is installed. This elastic band may be fabric or rubberized material in the appropriate width, thickness and elasticity for the particular cast type in a length to adequately wrap over the entire cast. Compressive pressure can be varied simply by pulling on the band as it is wrapped. This process will insure that every part of the cast is formed to the body and voids are not created. It should be expressly understood that, though this process is commonly used to apply compressive pressure to wounds, it is a unique process to apply it to temporarily form a cast that is in a warm and pliable state for the duration of cooling, then to be removed.

(69) Another method of forming with compressive pressure is that of an inflatable double walled cuff as shown in FIG. 18. The cuff would be appropriately sized to the extremity or adjustable in circumference and slid on the body part and cast while it is still warm and pliable. Air pressure is pumped into the cuff to apply compressive force as desired to form the cast and it is removed when cooled.

(70) The above unique combination of cast features provides a lightweight yet structurally rigid cast that is easily custom formed to the patient on site without the need for specialized training or skills. The resulting cast is patient compliant and can be adjusted as needed to increase compliance with its use. The adjustability can also decrease soft tissue injuries. The cast can be formed with dry heat so many heat sources can be used. The patient is protected from damage or discomfort from the heated cast during the forming process. The cast is waterproof and durable and can be reused and reshaped as needed. The materials used, being mostly polymers, provide a high degree of radiolucency. The body part can be examined through x-rays without the need to remove the brace as compared with Fiberglass and plaster which are not typically radiolucent. There is a reasonable potential for using recycled polymers in the construction of the middle layer that may impact the beverage container industry.

(71) The unitized casting system of this preferred embodiment may be provided in a relatively flat shape or generally in the shape for a specific body part, such as a wrist, ankle, knee or other body part as well as in general sizes, such as large, medium, small. The casts may also be pre-formed in some cases to approximately fit the body part for trial of size or in the case where a more complex structure requires it. The system can then be heated and custom shaped to specifically fit the body part that it is to support. The adjustable overlap also contributes to this custom fitting as discussed above. The unitized casting system will then fit the body part in a comfortable yet rigid manner.

(72) Examples of the preferred embodiments of the present invention used in other types of casts are shown in FIGS. 19-22. An example of a neck cast is shown in FIGS. 19 and 20. This use is of particular advantage since this area of the body is particularly sensitive and the contour shape varies greatly from person to person. A custom moldable, adjustable tension devise for this use that is soft foam lined and covered with an attractive outer layer can greatly increase the comfort and healing of the patient. A foot cast is shown in FIGS. 21 and 22. This use has advantages brought by the durable nature of the materials used since they are less prone to fatigue and cracking under body weight. In addition, the ability to adjust tension in this area prone to swelling is of great advantage. The unitized casting system 10 can be thermoformed utilizing a dry heat source in lieu of typical water activated materials presently in use. One disadvantage of these typical materials is that the body part, and often wounds associated with the injury are wetted during the casting process. They typically remain wet many hours after casting causing the skin to become uncomfortable, abraded and more prone to build up of microorganisms at precisely the time when sterility is most desired. Examples of the preferred embodiments of the present invention stay dry during the casting process and provide only a brief and comfortable thy heating of the body part. Healing begins in a dry environment less prone to the buildup of microorganisms and infection. The use of antimicrobial treatments incorporated inside the cast can be more effective in this dry environment.

(73) The casting system can also be shaped and secured to the body part without the need for extensive training since it is pre-made and not built on the patient. These pre-made casts have most of the labor done at the factory where they are manufactured saving valuable high cost hospital and clinic time adding considerable advantage. The casting system is also waterproof, lightweight and comfortable thus enhancing the patient's compliance in the use of the system. The polymer plastics used are much more durable than fiberglass or plaster and resist fatigue and cracking. This combined with ability to adjust the tension and size of the cast or remold it can allow a single cast to be used throughout the healing process where typical casts are replaced 1-3 times upon repeated visits to the hospital or clinic.

(74) Application

(75) In use, the unitized casting system 10 is provided as a kit to the individual, the orthopedic specialist, physician, technician, first responder or other entity. The appropriate kit type and size for the body part to be supported is selected. A dry heat source is applied to the cast 10 until the cast is sufficiently pliable to allow it to be shaped. This should be in the range 160 F to 300 F (Target Temperatures). The dry heat source can be an oven, microwave, or as discussed below, a heat bag, an internal heating mechanism or an exothermic heat source.

(76) Once the cast is sufficiently heated and pliable, approximately 5-10 minutes, it is applied directly to the body part as shown in FIGS. 23-25. The lower density polymer foam that makes up the inner layer 40 dissipates the heat so that that the individual does not suffer any pain or discomfort from the heat. The cast will be pliable, in the preferred embodiment, for about three to ten minutes. This allows ample time to form the cast about the body part. FIG. 15 shows the cast loosely fitted before compression molding to the body. An elastic wrap 80 is utilized to provide compression to mold entire cast specifically to the body part as shown in FIG. 17. The elastic wrap 80 applies pressure uniformly over the cast 10. The elastic wrap 80 can be an elastic band, or an elastic compression bandage formed from nylon/tricot knit, rubber, urethane, spandex or any other suitable material. Alternatively, as shown in FIG. 18, a compression tube 140, that is a double walled pneumatic tube, is slipped over the warm cast 10. The tube is inflated by hand pump 142 to apply pressure uniformly over the warm cast until the shape of the cast conforms to the body part. Comparing FIG. 23 with FIG. 25 shows how the compression molding method shapes the cast to the intimate contours of the body.

(77) The combination of the pliable heated thermoformable layers along with the uniform pressure forms the cast to the body part. The mid layer provides the majority of the shape and support. The inner layer, if formed of a thermoformable material will also shape to conform about the body part as well. The outer layer, in the preferred embodiment, does not thermoform, but will stretch to follow the shape of the mid layer. Since it does not thermoform, it will not pick up the imprint of the elastic wrap or compression tube and will remain smooth and attractive in appearance. This layer can be thermoformable at the Target Temperature if these features are not desired.

(78) Once the shape of the cast has been achieved, the elastic wrap 80 is removed or the compression tube 140 is deflated and removed. The cast is secured to the body part by securing closure 50. The cast will support the body part as well as remain comfortable during its use. The cast can easily be removed if necessary and reformed as needed.

(79) Heat Sources

(80) The present invention also, in a preferred embodiment, provides a heat source for heating the casts to the Target Temperature as described above in order to shape the system to the body part. One preferred embodiment of the heat source, as shown in FIG. 26, includes a heating pouch 100 that is easily stored and transported. The heating pouch includes an outer insulation layer 102, opposing heating elements 104 in a sheet fashion and a liner bag 106, as shown in FIG. 27, preferably durable on the outside and non-stick on the inside, that holds the heating element and insulation. The heater elements can be made of electrical heat wire or heating foil or other electrically activated design. The heater bag 100 is easily opened to accept the cast and closes during the heating process. A closure system such as hook and loop, zipper of buckles closes the bag to hold in heat. The heater element is connected to an electrical power source, either 110-240 VAC standard plug for connection to an electrical outlet, or a 12 V transformer or a 12V DC battery or vehicle electrical power source and maintains the Target Temperature accurately via a thermostat or heat control device. The heating pouch may also include an optional temperature probe that monitors the temperature applied to the bracing system.

(81) In use, the unitized casting system 10 is placed in the case between the opposing heater elements. The case is activated causing the heater elements to heat the cast 10. Once the cast is heated sufficiently to the Target Temperature and adequately pliable, it is removed for application and forming around the body part.

(82) This heat source case is easily transported and able to be used in hospitals, clinics, training rooms or even on site for treating an injury. Special ovens or chemical reactions are not needed.

(83) Another heat source of a preferred embodiment of the present invention uses an internal heating mechanism built into the unitized cast. This may be an electric grid on one or both sides of the middle layer. This grid is connected to a power supply which supplies electric current to heat the middle layer to the target temperature. Once forming of the cast is complete, the electric current is turned off and the cast quickly cools. This eliminates the need for an external heating device since it is built into the cast.

(84) Another heat source under a preferred embodiment of the present invention utilizes an exothermic heat source 120 as shown in FIG. 28. A number of chemical reactions exist that produce heat such as carbon/air, Lye/water, air batteries and others. When two or more elements are exposed to each other, the resulting chemical reaction causes heat to be released. Typical common uses are carbon/air packets used as pocket heaters for cold weather and Lye/water containers used to heat army Meals ready to eat. Similar systems can be used to heat the casts of the preferred embodiment to the Target Temperature by incorporating the heating chemicals into a plastic pouch or bag with adequate room to insert the cast. The chemical reaction is made and the cast heated, removed and applied. The advantage of such a system is that injury often occurs in the field where medics or doctors do not have access to electricity. This method provides a quick simple method to heat the cast in a self contained fashion and apply it in the methods described above.

(85) Other heating means include convection ovens, toaster ovens, radiant lamp heat sources, Infrared heaters and microwave ovens. A convection forced air oven 130 may be used as well as shown in FIG. 29. Microwave heating does not typically heat polymers, however, special additives or layers could be used to trap the heat provided by microwaves. Another method for heating in a microwave is to place the cast inside of a plastic bag containing a small amount of water or liquid. The liquid is quickly heated by the microwave and thus heats the cast. Other embodiments may be used as well that provide a dry heat source for heating the cast system to temperatures up to about 250 degrees Fahrenheit. These systems may also include timers as well as temperature probes and alarms when the temperature of the cast system has reached the desired temperature.

(86) These and other features of the present invention are considered to be within the scope of the invention as claimed. The above descriptions are provided for exemplary purposes and are not intended to limit the scope of the claimed invention.