Source: https://patents.google.com/patent/US20080319362A1/en
Timestamp: 2019-08-24 11:29:42
Document Index: 367468125

Matched Legal Cases: ['art.\n3', 'art.\n9', 'art.\n13', 'art.\n14', 'art.\n18', 'art.\n22', 'art.\n24', 'art.\n27']

US20080319362A1 - Orthopedic System for Immobilizing and Supporting Body Parts - Google Patents
US20080319362A1
US20080319362A1 US12/013,449 US1344908A US2008319362A1 US 20080319362 A1 US20080319362 A1 US 20080319362A1 US 1344908 A US1344908 A US 1344908A US 2008319362 A1 US2008319362 A1 US 2008319362A1
US12/013,449
US8303527B2 (en
2008-01-13 Application filed by Exos LLC filed Critical Exos LLC
2008-01-13 Assigned to EXOS CORPORATION reassignment EXOS CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: JOSEPH, MARK
2008-12-25 Publication of US20080319362A1 publication Critical patent/US20080319362A1/en
2012-02-22 Assigned to EXOS CORPORATION reassignment EXOS CORPORATION CONFIRMATION OF ASSIGNMENT Assignors: JOSEPH, MARK
2012-03-08 Assigned to PRODUCT INNOVATIONS, INC. reassignment PRODUCT INNOVATIONS, INC. SECURITY AGREEMENT Assignors: EXOS CORPORATION
2012-11-06 Publication of US8303527B2 publication Critical patent/US8303527B2/en
2014-02-19 Assigned to EXOS LLC reassignment EXOS LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: EXOS CORPORATION
2018-12-13 Assigned to EXOS CORPORATION reassignment EXOS CORPORATION RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: JOSEPH, MARK, PRODUCT INNOVATIONS, INC.
This application claims priority of provisional patent application 60/945,277 filed on Jun. 20, 2007.
Plaster casts were used consistently and devotedly until the 1980's when fiberglass materials became available. Though more expensive and somewhat more difficult to work with, fiberglass soon became the preferred casting material in many clinics and hospitals, and remains so today. It offered increased lightness, somewhat better visibility under x-ray, and was resistant to softening if wet. Unlike plaster rolls or strips which could remain open on the shelf, fiberglass would gradually harden if exposed to air and needed to be packaged in airtight bags. Fiberglass still required water activation to harden into a usable cast, and was highly user dependent in the quality of the final product. It has sharp edges, folded corners can produce skin ulcers, and it can be more difficult to remove than plaster. It is available in rolls of various sizes (2″, 3″, 4″, 5″, & 6″) A cast saw with a good blade is necessary for its removal. Fiberglass and plaster remain the most commonly used material casting in orthopedics today.
A variation on fiberglass is the Delta-cast brand (distributed by BSN Medical) of roll fiberglass casting tape material that is more pliable and less rigid than fiberglass, has improved radiolucency, and can be cut with a scissors as well as with a cast saw. It comes in rolls similar to fiberglass and is wrapped around the injured extremity over a cotton or fabric padding under-layer in the same fashion as plaster and fiberglass. It too is water activated. It is slightly more expensive than fiberglass, but has advantages of comfort and enough flexibility to be removed in some instances.
Splints are typically rigid supports made of various substances, plaster, fiberglass, plastic, metal, or inflatable materials, which temporarily support an injured extremity. They often are applied to only one surface of a limb and may be held in place by an elastic bandage, hook and loop, or other wrapping. They generally do not rigidly encircle a limb to allow for swelling in the early stages of an injury. Typically they are applied in an emergency setting, worn for less than a week, are discarded after transition to a more long term support system when seen in an orthopedic clinic. One common material used for splints is Ortho-Glass distributed by BSN Medical. This material is a limp fiberglass material impregnated with water activated resin and covered with a non-woven fabric. It is wetted and held to the body with elastic bandage while it cures in a few minutes.
The prior casting systems are designed to be constructed from multiple separate materials. This requires the practioner to be skilled in utilizing these materials and applying these materials, such as plaster, fiberglass or Delta-cast to create the cast on the patient. Also, the padding must be applied initially before the casting material is applied. Any problems with either of the materials requires the entire process to be restarted.
The preferred embodiment of a casting system under the present invention is made up of several layers of materials that each provide a separate function and combine to create a unique casting product. A soft foam layer next to the skin eliminates the need for wrapped layers of roll padding typically used. It also provides insulation protection to the patient as well as insulating the middle layer to maintain the temperature of the middle layer during the casting process. A rigid plastic middle portion consisting of one or more connected parts hidden inside the foam layers, provides rigidity and support, replacing the typical plaster or fiberglass multi layer wrap. The outer layer insulates the middle layer, hides the rigid middle layer and is comfortable for other parts of the body to touch thus preventing irritation and abrasion during activity and sleeping (which typically occurs with abrasive plaster and fiberglass systems that have no soft outer cover). The cast is completely pre-assembled before it is heated for forming and is quickly applied with one wrap around the extremity when pliable to provide a custom fit. Cooling to room temperature occurs naturally in a few minutes providing an anatomically conforming rigid cast in one step. This provides a clear advantage over the multi step, time consuming process of creating a typical “in situ” cast.
A preferred embodiment of the casting system of the present invention is made pliable and formable by dry-heat rather than the heated water of existing formable cast systems. Other typical systems use hot water to heat the material or use a moisture activated catalyst method to cure the fiberglass tape or plaster to become hardened. In this preferred embodiment, this heating can be accomplished in a specialized electric heater-pouch or a small, easily portable convection warming oven or a such as are commonly found in orthopedic casting bays. The cast can also be heated in a specialized exothermic chemical reactive heating pouch such as army “meals ready to eat” are heated in the field. These thermo-moldable casts require warming to the desired temperature range until the layers are heated evenly through. The low mass and insulating features of the foam outer layers protect the skin from the heated plastic middle layer to allow people and animals to tolerate this heat without any difficulty. The product remains completely dry against the skin thus avoiding the mess and cleanup required of other wet systems as well as many hours the patient must spend wet and uncomfortable as the typical cast dries. In addition, germs and bacteria that can easily multiply in this wet environment are avoided. Antimicrobial treatment may be applied to the inner layer to further reduce the likelihood of infection.
A preferred embodiment of the present invention is water-proof. It has no fabric, cotton, or synthetic material between the skin and the cast to retain moisture which can be uncomfortable or cause maceration. It will not deteriorate if it becomes wet. It air dries in a brief time due to its non-absorbent properties and can be more quickly dried with a hair dryer than systems using absorbent padding layers. This has importance in terms of hygiene, recreational use, return to work, sport, and veterinary utility.
A preferred embodiment of the present invention is durable. It uses modern synthetic thermoplastic technology and the science of tubular and cylindrical physics to provide stabilization and support without sacrificing lightness. The mechanical properties of the rigid middle plastic layer (and also the foam layers) can be varied by using different materials, thicknesses or perforations to provide precisely the desired rigidity, flexibility and even hinging as desired for each medical application. These flexing/rigidity features can be achieved without sacrificing durability by using polymer materials that allow the desired degree of flexing, yet resist fatigue and cracking over a long cycle life. When compared with typical plaster or fiberglass systems, which are not so easily engineered, and have poor resistance to flexing and fatigue, the benefits of the preferred embodiment are of great value.
FIG. 17 is a perspective view of the cast system undergoing compression for shaping about the patients wrist.
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 adjusted 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.
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.
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
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™. 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.
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 increases 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.
The foam cools by the mold and holds it's shape.
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.
The securing mechanism 50 of the casting system 10 of a preferred embodiment allow 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.
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 with out 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.
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 dry 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
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
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.
1. A cast system for supporting a body part, said cast system comprising:
a flexible inner foam layer for providing insulation and cushioning against the body part;
a middle layer that is formable with dry heat to conform about a body part while providing support for the body part when said middle layer is cool and rigid;
a flexible foam cushioning outer layer for providing insulation for said heat formable layer wherein said inner layer, middle layer and outer layer are assembled together to form a unitized cast.
2. The cast system of claim 1 wherein said inner layer and outer layer insulate said middle layer to maintain said middle layer at a temperature at which said middle layer is formable 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 outer layer insulate and dissipate heat of said middle layer from the body allowing said layers to be heated up to 250 Fahrenheit without causing discomfort the skin of the body part during forming on the body.
4. The cast system of claim 1 wherein said middle layer includes:
perforations in said middle layer removing twenty to sixty percent of said middle layer to allow said middle layer to better conform to the body part and at lower temperatures.
5. The cast system of claim 1 wherein said middle layer includes:
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 at lower temperatures.
6. The cast system of claim 1 wherein said casting system includes:
said middle layer is formed of a heat formable material; said heat formable material being selecting from the group consisting of: Amorphous Polyethylene Terephthalate (“APET”), Recycled Polyethylene Terephalate (“RPET”), Polyvinyl Chloride (“PVC”), PVC foam, polycaprolactone, caprilactone, Polyethylene and derivates of those materials.
7. The cast system of claim 1 wherein said middle layer includes:
a material heat formable at a temperature of about 250 degrees Fahrenheit or below.
8. The cast system of claim 1 wherein said middle layer includes:
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 includes:
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 includes:
a material that is heat formable at a temperature of 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 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 wherein said cast system further comprises:
at least one additional layer adjacent said inner layer to provide additional comfort to the body part.
13. The cast system of claim wherein said cast system further comprises:
at least one additional layer adjacent said inner layer to provide anti-microbial protection to the body part.
14. The cast system of claim 1 wherein said cast system further comprises:
at least one additional layer adjacent said outer layer to provide durability and aesthetics to said cast system.
15. The cast system of claim 1 wherein said cast system further comprises:
at least one additional layer to said cast system for providing additional therapeutic benefits to said cast system.
16. The cast system of claim 1 wherein said cast system further comprises:
at least one ventilation hole 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 cast system includes:
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 cast system includes:
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 cast system includes:
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 wherein said system further includes:
an attachment mechanism assembled on said cast system for securing said system around the body part.
22. The cast system of claim 1 wherein said system includes:
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 wherein said system includes:
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 wherein said system further includes:
An adjustable securing mechanism on said cast system that mechanically allows the practitioner to set said mechanism on said cast with a special tool to be prevented from being loosened by a patient but can be adjusted by the practitioner; to be partially loosened but not removed by a patient to a degree specified by the practitioner; and to be fully adjusted and removed by a patient.
25. The cast system of claim 1 wherein said system includes:
the edges of said middle layer are set back from the edges of said inner layer and said outer layer to encapsulate said middle layer.
26. The cast system of claim 1 wherein said system further includes:
a dry heat source for heating said system for shaping around the body part.
27. A cast system that is formable about a body part to support the body part, the cast system comprising:
a material that is rigid at temperatures below about 140 degrees Fahrenheit and is heat formable at a temperature of about 200 degrees Fahrenheit for a dwell time sufficient to allow said cast system to be formed to closely 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 the inner layer and the outer layer and combinations thereof.
28. 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 an inner portion having a higher density that is rigid at temperatures below about 140 degrees Fahrenheit and is heat formable at a temperature of about 200 degrees Fahrenheit where said outer portions have a lower density to provide insulation and cushioning comfort around said inner portion and to insulate said middle layer for a time sufficient to allow said heated cast system to be formed to the body part.
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