Patent Document

RELATED APPLICATIONS 
     The present application is related to U.S. Pat. No. 6,974,431, issued Dec. 12, 2005, included by reference herein. 
     The present application is related to U.S. Pat. No. 4,817,590, issued Apr. 4, 1989, included by reference herein. 
     The present application is related to U.S. Pat. No. 4,235,228, issued Nov. 25, 1980, included by reference herein. 
     The present application is related to U.S. Pat. No. 3,900,024, issued Aug. 19, 1975, included by reference herein. 
     The present application is related to U.S. Pat. No. 3,415,243, issued Dec. 10, 1968, included by reference herein. 
     The present application is related to U.S. Pat. No. 3,307,537, issued Mar. 7, 1967, included by reference herein. 
     No known patents for serial casting 
     FIELD OF THE INVENTION 
     The present invention relates to total contact casting and, more particularly, to a unique turn key, user friendly modality that provides intimate contact, and promotes better body mechanics, which have proven to be the key components in healing diabetic and neuropathic foot ulceration. The system accommodates a variety of conditions that lead to range of motion disorders and allows the condition to be treated while maintaining quality of life. 
     BACKGROUND OF THE INVENTION 
     Diabetic and neuropathic foot ulcerations can be challenging wounds to heal. The etiology of these ulcerations can vary from compromised blood flow to arthritis, and other conditions and co-morbidities. Total contact casts have been utilized for decades for the treatment of diabetic, neuropathic foot ulcerations, as well as charcot foot deformities. 
     Total Contact Casting was introduced to the United States nearly 70 years ago from the leper colonies of India and was adopted by our clinicians for the treatment of neuropathic and diabetic foot ulcerations. The total contact cast configuration and application protocol has remained almost exactly the same since the introduction with the exception of new lighter weight materials. This approach to total contact casting is the first new cast configuration that is truly unique from all other systems and has proven to be clinically effective. 
     Total Contact Casting as described in the name is meant to have as close to intimate contact with the patients leg as possible. This intimate contact is designed to secure the foot and leg in a position that allows for the patient to ambulate while removing the pressure and propulsive forces from the wound and not allowing the foot to move in the cast. The total contact cast should be applied weekly with the exception of the first week at which the cast should be re-applied during the first 48 to 72 hours to accommodate the reduction of swelling and edema in the leg. 
     A typical total contact cast is applied in several layers. These layers are comprised of a stockinette, a felt pad covering the length of the tibia, a pad covering the lateral and medial maleolous, a layer of rigid plaster, one to two layers of cast padding, a layer of fiberglass, a posterior splint that is fabricated out of a roll of fiberglass tape, unfurled and folded to be three to four layers thick when applied, a rigid walker plate, a rubber walker heel, and a final roll of fiberglass that the clinician will continue rubbing until the cast sets up, approximately ten to twelve minutes post application. 
     Even the casting system identified in U.S. Pat. No. 6,974,431 is the same as the original total contact cast configuration except in a kit form. There are inherent flaws that all of these accepted existing total contact casting systems have in common that have not been addressed. 
     Currently less than 2% of clinicians utilize total contact casting to treat their diabetic and neuropathic foot ulcer patients. Past objections to total contact casting were the time it takes to apply, the cost of materials, consistency of application, weight of a cast, and patients developing back and hip pains due to the change in the length of the leg which greatly effects the body mechanics of these already compromised patients. 
     In addition to the diabetic and neuropathic ulceration application, this versatile system can be utilized as a serial casting system for improving the range of motion for burn, cerebral palsy, spinal bifida, spinal cord injury, muscular dystrophy, idiopathic toe walking, and peripheral neuropathy patients. Applied weekly, gradually increasing the range of motion to a specific limb. This is a non-surgical approach aimed at reducing muscle tightness around the joint that is limiting the range of motion and functional mobility. 
     Other solutions in existence have merely tried to address the time of application and consistency issues without getting to the core of the problem. Jensen and Gillin developed a cast kit that incorporated all of the components that the clinician would typically assemble separately into one box. The components in the Jensen and Gillin system are essentially the same as any clinician would pull from their inventory with the exception of a unique felt pad that takes what would be two individual pads, the tibial crest and the maleoli pad and connected them as a one piece system. (U.S. Pat. No. 6,974,431) 
     There is an existing system that resembles a fiberglass sock. This system is not rigid, does not provide intimate contact to the leg, and has to be placed in a removable walker boot to support the system. 
     Other casting systems discovered during the patent search were designed for stabilizing fractured bones and not for the treatment of a specific condition such as diabetic and neuropathic foot ulcerations. 
     Currently serial casting consists of specific products that are assembled by a technician to accommodate the defect. This system is geared towards providing all of the components to accommodate a wide range of indications. Additionally this system is universal and will accommodate children to adults. 
     Conventional total contact casting systems tend to be time consuming, extend the length of limb, can create additional ulcerations, and are difficult to remove. 
     The Jensen and Gillin system follows the traditional total contact cast configuration with exception to the felt pad that they utilize over the tibia of the leg. Historically there was a separate pad that runs distally from just under the fibular head down to the dorsal aspect of the foot. Additionally there were two felt pads that covered the maleolous to protect them during removal. The pads are taped onto the stockinette while preparing for the cast. Jensen and Gillin connected the maleoli pads creating a one piece system. The Jensen/Gillin system is very time consuming and in most cases requires two clinicians to apply. Once the final roll of cast tape is utilized a clinician has to continue rubbing the fiberglass so that it doesn&#39;t un-roll while setting up. This requires approximately 20 minutes to apply and cure. 
     Another key factor that has effected the popularity of casting are complaints by the patients of hip and back pain. These systems are being utilized for five to eight weeks so the patient is in the cast for quite some time. Existing total contact casting systems utilize several rolls of padding, plaster, and fiberglass to build up the body of the cast. Prior to the application of the rubber walker heel and the last roll of fiberglass a thick rigid plate is placed on the plantar surface of the foot extending from the heel to just under the toes. This plate adds a significant amount of length to the cast as it is not just the thickness of the plate but the fact that it is being balanced at the heel and solace of the foot which are the high points of the plantar foot surface. The plate is utilized to help re-distribute the weight of the patient evenly over the entire foot. Subsequently the plate increases the length of the leg making it disproportionately longer than the other leg thus throwing off the natural body mechanics and causing hip and back pain. Prior systems tend to use traditional components that are very heavy which just exacerbate these conditions for the patient. The Jensen/Gillin system incorporates the heavy materials and a very thick walker plate which doesn&#39;t address the issues that have been associated with total contact casting for decades. 
     Total Contact Casting is meant to have very close contact with the patients limb. This is important in order to assure maximum pressure offloading to the ulcer and minimize movement in the cast. Prior systems utilize cast padding as the first layer covering the stockinette and felt tibial crest pad. This padding breaks down and compresses creating space within the cast. Subsequently, the foot pistons forward and backwards in the cast creating additional ulcerations and pressure points. 
     Contact Cast removal has been a long standing issue and in several cases where patients have ended up with serious injuries as a result. Prior total contact casting systems are cut down the center of the tibia, over the tibial crest pad, along the dorsum of the foot, over the toes, and then wedges are cut over the maleoli pads. The cast has to spread at the center while supporting the leg with opposing pressure until the cast breaks. This requires a lot of strength and can be very time consuming. Occasionally patients have excessive swelling and end up at the emergency room for removal. A traditional below the knee cast cuts on the lateral and medial sides of the leg with the center removing so the cast literally falls off of the leg. There have been numerous situations where patients have gone to emergency and since the typical doctor is not familiar with the total contact cast removal have cut into and burned the patients legs. None of the prior systems have addressed this chronic struggle up to this time. 
     There are no known existing serial casting systems commercially available for clinicians to utilize. 
     It is therefore an object of the invention to provide a turn key, user friendly casting system. 
     It is another object of the invention to provide a versatile casting system that promotes consistency of application. 
     It is another object of the invention to provide a casting system that can be utilized for a variety of defects and conditions. 
     It is another object of the invention to provide a casting system that produces re-producible clinical outcomes. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, there is provided a system that is clinically and effically sound, consisting of proprietary components that not only address the needs of the clinician but are universally utilized in a concise protocol covering a wide range of indications and conditions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which: 
         FIG. 1  is a front view of a patient&#39;s leg and foot with a wound dressing covering the defect; 
         FIG. 2  is a front view of a patient&#39;s leg and foot with first layer which is a protective stocking; 
         FIG. 3  is a front view of a patient&#39;s leg covered with a stocking and the self adhesive protective toe cover applied and trimmed to the contour of foot; 
         FIG. 4  is a front detail view of a patients leg and foot ready to cast, prepared with the stocking, toe protector, lateral and medial offloading strips, maleoli strips, tibial bridge, and mid-tibial pad; 
         FIG. 5  is a right detail view of a patient&#39;s leg and foot in the prone position, prepared for casting; 
         FIG. 6  is a right detail view of a patients leg and foot with the first roll of elastic plaster applied over the stocking, foam toe protector, and proprietary felt offloading and maleoli strips, providing intimate contact with the leg; 
         FIG. 7  is a right detail view of a patient&#39;s leg and foot with first roll of fiberglass tape covering the elastic plaster, essential for the correct positioning of the foot providing a rigid shell adding strength to the cast; 
         FIG. 8  is a right detail view of a patient&#39;s leg and foot with the extra strength pre-fabricated posterior splint covering the planter surface hanging over the posterior aspect of the leg and secured at the proximal end with the excess stocking; 
         FIG. 9  is a right detail view of a patients leg and foot with the final roll of fiberglass tape applied, securing the proprietary rocker walker, aligned with the anterior tibia, while forming the pre-fabricated posterior splint to the patients limb providing maximum support to the foot and ankle; and 
         FIG. 10  is a right detail view of a patient&#39;s leg and foot with a completed cast application, and the self adhering dressing securing the loose end of the fiberglass tape. 
     
    
    
     For purposes of clarity and brevity, like elements and components will bear the same designations and numbering throughout the Figures. 
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1  is a front view of a patient&#39;s leg dressed and ready for cast preparation. 
       FIG. 2  is a front view of a patient&#39;s leg with the first protective initial leg cover. 
       FIG. 3  is a front view of a patient&#39;s foot with proprietary toe protector, trimmed to fit contour of the foot. 
       FIG. 4  is a front detail view of a patient&#39;s leg prepared with proprietary felt lateral and medial offloading and maleoli strips. 
       FIG. 5  is a right detail view of a patient&#39;s leg in prone position, prepared for casting. 
       FIG. 6  is a right detail view of a patient&#39;s leg with initial roll of elastic plaster casting material. 
       FIG. 7  is a right detail view of a patient&#39;s leg with first roll of fiberglass that is wet and rolled to cover to just below fibular head. 
       FIG. 8  is a right detail view of a patient&#39;s leg with the proprietary extra strength pre-fabricated splint. 
       FIG. 9  is a right detail view of a patient&#39;s leg and foot with final roll of fiberglass securing proprietary rubber rocker walker. 
       FIG. 10  is a right detail view of a patient&#39;s leg with finished cast. 
     Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention. 
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to the figures, in which like reference numbers refer to like components thereof,  FIG. 1  shows the foot of the patient covered by wound dressing  101 .  FIG. 1  is an example of a wound dressing application. A high percentage of diabetic and neuropathic patients will develop foot ulcerations. These patients have little or no feeling resulting in insufficient sensory feedback so they are unable to adjust the gait for the insensate foot causing tissue damage and ulcerations on the plantar surface. If these types of defects are left untreated they often require subsequent amputation of the limb. 
     There is science based evidence that supports the methodology of offloading pressure from the wound removing the propulsive forces that stall the healing process. In the late 1930&#39;s a method of applying a rigid cast with little padding was introduced and was recognized as the “Gold Standard” for treating plantar surface ulcerations. There have been many concerns and issues relating to this modality that have led to underutilization amongst clinicians. The apparatus and method of the present invention addresses all of these concerns making the application more comprehensive, leading to faster wound healing times. In addition, the present invention accommodates deformities such as valgus, varus, equinus, and charcot foot which make up a large percentage of patients with plantar ulcerations. 
       FIG. 2 , illustrates a patients leg with the first layer  102 , is the first protective layer, consisting of a cotton tube stocking that covers the leg circumferentially allowing subsequent components to be attached. The cotton tube stocking covers above the knee distally and folded over the toes. 
       FIG. 3 , illustrates the patients leg with protective self-adhesive perforated foam toe pad.  103 , the self adhesive perforated foam toe pad  103 , is applied over the distal toe area to protect the toes from potential cast abrasions. The self-adhesive foam toe pad  103 , is perforated to allow air to moisture transfer keeping the toes dry reducing risk of maceration and fungal infection. The self-adhesive perforated foam toe pad  103 , is placed over the distal toes covering distal end of cotton tube stocking  102 , evenly distributing the perforated self adhesive foam toe pad  103 , over the dorsum to the plantar surfaces and is trimmed to fit the contour of the lateral and medial sides of the foot. 
       FIG. 4 , illustrates the patients leg with the self-adhesive felt lateral and medial strips  104 , secured from the proximal tibia just below the tibial tuberosity to the bottom of the malleolus attached to the cotton tube stocking  102 , with the self-adhesive felt maleoli strips  105 , overlapping the distal end of the self-adhesive felt lateral and medial strips  104 , connecting to the proximal edge of the self-adhesive perforated foam toe pad  103 . The proximal tibia is lined with a self-adhesive felt tibial crest bridge  106 , and distally with additional self adhesive felt strips  107 , to protect the tibial crest to the talus area of the foot. The unique configuration of felt strips protects all of the bony prominences that typically become pressure points, causing tissue degradation and additional ulcerations. Traditionally a single wide protective strip is applied over the tibial crest and patches are applied over the malleolus. By utilizing self-adhesive felt lateral and medial strips  104 , and overlapping the self-adhesive felt maleoli strips  105 , more of the patient&#39;s surface area is protected reducing the risk of additional ulcerations, also making the cast removal much easier and faster. 
       FIG. 5 , illustrates the patients leg in the prone position consisting of the cotton tube stocking  102 , self-adhesive perforated foam toe pad  103 , self-adhesive felt lateral and medial strips  104 , self-adhesive felt maleoli strips  105 , self-adhesive felt tibial bridge  106 , and self-adhesive felt tibial crest strips  107 . The patient is placed in the prone position as it reduces the incidence of toe-drop which can lead to improper cast application. It is important that the foot is secured in a ninety degree position for proper application and offloading. The present invention is unique as it removes in a bi-valve configuration meaning that the cast can be removed with a cast cutting saw by making parallel cuts on the lateral and medial sides of the leg and down the center of the self-adhesive felt lateral and medial strips  104 , which can be easily identified by the ridges on either side of the cast. Cuts are then made distally across the self-adhesive lateral and medial maleoli strips  105 , and over the distal toe area. The center of the cast is pulled free allowing for the cast to easily be removed from the patient&#39;s leg. 
       FIG. 6 , illustrates the patients leg in the prone position prepared for the first rigid layer after the felt and cast padding which is fine plaster or fiberglass  108 , casting material commonly referred to as the egg shell layer. The first plaster layer  108 , is the basis for intimate contact and is the layer that contours to the protective components. The first layer  108 , eliminates the risk of the protective felt strips floating and creating a pathway for shear forces that can lead to secondary ulcerations. 
       FIG. 7 , illustrates the patients leg in prone position, with the said first layer of a fiberglass  109 , applied over the said plaster  108 , and is applied by hydrating the material, rolling circumferentially from the distal edge of the plaster first layer  108 , up the leg to the proximal edge of the first plaster  108 . The said first fiberglass layer  109 , of casting material is applied providing strength to the cast. The cotton tube stocking  102  at the proximal end of the cast is left exposed so it can later be folded down to create a soft collar. 
       FIG. 8 , illustrates the patients leg in prone position and the multi-layer prefabricated support splint  110 , being applied over the said first fiberglass layer  109 . The multi-layer prefabricated support splint  110 , is applied between the said first fiberglass layer  109 , and the said second fiberglass layer  112 . The multi-layer prefabricated support splint  110 , is applied starting at the proximal edge of the posterior side of the cast, down the leg, across the plantar surface, overhanging at the toes and around the self-adhesive perforated foam toe pad  103 . The excess cotton tube stocking  102 , is rolled over the top of the multi-layer prefabricated support splint  110 , to secure it in place and create a soft collar around the proximal rim of the cast. The excess multi-layer prefabricated support splint  110 , material overhanging at the toes can be trimmed off in strips to level the rocker/walker  111 , accommodating patients with specific anatomic foot defects. Traditionally a clinician will fabricate a splint by taking a fiberglass roll, unrolling it and folding it into approximately 3 layers. The present invention contains a multi-layer prefabricated support splint  110 , that is prefabricated and the equivalent thickness of two and a half traditional support splints adding significant structural integrity. The added strength of the support splint reduces the number of layers needed to cast a patient as well as application times. 
       FIG. 9 , illustrates the patients leg in the prone position with rocker/walker  111 , in position for attachment after said second fiberglass layer  112 . The rocker/walker  111 , is Positioned with the front of the back walker pad in alignment with the anterior tibia of the leg and sitting directly on the prefabricated multi-layer support splint  110 . There is front to back orientation to the rocker/walker  111 , designed to promote normal bio-mechanics during ambulation. Typically a cast utilizes a plate that lies on the plantar surface to accept the walker heel. The current invention has eliminated the walker plate by designing an extremely thick multi-layer prefabricated support splint  110 , that will accept the rocker/walker  111 . The said second layer of fiberglass  112 , is utilized to secure the rocker/walker  111 , while adding additional strength the cast. The said second layer of fiberglass  112 , is applied by hydrating the material, starting at the styloid process distally around the toes, circling the heel and back around until fiberglass overlaps. When adjacent to the metatarsal head the fiberglass is rolled circumferentially over the dorsum, securing the loose end of the multi-layer prefabricated support splint  110 , than pinning the front of the rocker/walker  111  circumferentially around the foot and twisting the fiberglass to create a rope effect, running through the rocker/walker  111 , center, around the heel securing the back of the rocker/walker  111 , and proximally up the leg to the edge of the cotton tube stocking  102 . The elimination of the traditional walker plate lowers the length of limb or cast length significantly and promotes normal ambulation. 
       FIG. 10 , illustrates the patients leg in the prone position with the completed cast ready to receive the said self adhering dressing  113 , to finish the cast. The self adhering dressing  113 , is utilized to secure the loose end of said second fiberglass layer  112 , starting at the edge of the said cotton tube stocking  102 , rolling distally towards the said rocker/walker  111 , until roll is utilized. 
     Having thus described the invention, what is desired to be protected by Letters Patent is presented in the subsequently appended claims.

Technology Category: 1