BACKGROUND OF THE INVENTION

[0001] Diabetic foot ulcers are a global problem, for instance from diabetes people suffer from poor blood flow such developing sores, open wounds, on their feet.

Such sores, ulcers, negatively affect the individual's lifestyle limiting his/her mobility functions and costing the individual expensive recoveries. In some cases, diabetic foot ulcers can lead to amputation that can result in heavy financial burden on the healthcare system.

[0002] Off-loading the patient's weight from the wound is today an open option and it is executed via different avenues by applying a total contact cast to the patient's leg. [0003] The available methods are not completely effective because their use is time consuming and costly to the patient and to the healthcare system.

[0004] Some of their common shortcomings are relatively: hard to put on and to take off, uncomfortable, non breathable, ineffective at offloading or adapting weight from open wounds, suffocating pressure by edema pressure, could cause wounds with burns during removal of casts.

[0005] Challenges still exist. Relatively, it would be an improvement in the art to replace current techniques with other technologies.

SUMMARY OF THE INVENTION

[0006] The present invention relates to an orthopedic total contact cast system that can be used for treatment of diabetic foot ulcers on legs and on feet. Indeed, the described total contact cast can be used to support a patient's foot and leg, while offloading weight and distribute such weight to other parts of the foot or and leg.

[0007] The described total contact cast includes two or more fiber glass cast rolls, underlayments as sterilized cotton, a tubular stockinette, a ventilated foot support with optionally an adjustable arch support. It is equipped with a set of plastic ventilation and filtering nipples. A set of compressible, venting 3D fabric spacers with perforated, protruded venting layers to protect the limb from the edema pressure. Aerating semi flat tubes at the posterior side of the leg and the foot to refresh the plantar base of the foot and to dissipate bad odours away from the cast.

A rolled and medicated 3D venting fabric spacer to incorporate between the toes. A protective cover for the phalanges made of adhesive foam or from an elastic expandable net.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 shows the wounded foot of a patient.

[0009] Figure 2 shows the foot of Figure 1 with an applicable wound care dressing.

[0010] Figure 3 shows an explosive view of a toe separator.

[0011] Figure 4 shows an assembled toe separator.

[0012] Figure 5 shows a foot with an installed separator.

[0013] Figure 6A shows a prospective view of a leg of Figure 1 covered by a tubular stockinette.

[0014] Figure 6B shows a prospective view of

Figure 6A with lateral 3D fabric spacers.

[0015] Figure 7 shows prospective view of Figure 6A with frontal 3D fabric spacer.

[0016] Figure 8 shows leg of Figure 7 with installed 3D fabric spacer.

[0017] Figure 9 shows leg of Figure 6A with posterior 3D fabric spacer ready to be installed. [0018] Figure 10 shows leg of Figure 9 with dorsally attached 3D fabric spacer.

[0019] Figure 11 shows leg of Figure 9 with a pair of 3D fabric spacers discs ready to be assembled on leg of Figure 11.

[0020] Figure 12 shows leg of Figure 11 with 3D fabric assembled on the frontal and on the posterior parts via surgical tapes.

[0021] Figure 13 shows leg of Figure 12 with 3D fabric spacers discs fully assembled on the malleoli of the leg.

[0022] Figure 14 shows an explosive view of the venting elements to be applied on the foot. [0023] Figure 15 shows the venting elements of the figure 14 fully assembled on the foot.

[0024] Figure 16A" shows the perforated foam as in AF with "L" adhesion surface to make a protective pocket for the phalanges.

[0025] Figure 16A" shows a patient's leg on top of AF foam.

[0026] Figure 16A" shows cover AF ready to cover the foot F.

[0027] Figure 16B is a prospective view of Figure 16A with adhesive foam fully assembled on foot. [0028] Figure 17A shows foot of figure 15 with an elastic net being open in order to cover its foot.

[0029] Figure 17B shows foot of figure 15 with an elastic net fully assembled on the foot.

[0030] Figure 18A shows an explosive view of the venting elements for the stepping base of the foot of Figure 16.

[0031] Figure 19A shows leg of Figure 16B ready to be immobilized by a cast.

[0032] Figure 19B shows leg of Figure 16B ready to be immobilized by a cast. [0033] Figure 20 shows an explosive view of the leg of Figure 2 covered by cotton and ready to be assembled with its plantar venting elements.

[0034] Figure 21 shows the leg of figure 20 with its plantar venting elements fully assembled waiting for the casting assembly.

[0035] Figure 21A shows in an explosive fashion the main layers of Figure 23B for a total contact cast assembly.

[0036] Figure 22 shows the elements of a venting stepping base for leg of Figure 2.

[0037] Figure 23A shows leg of Figure 2 inside a vented total contact cast ready to fit inside a walking shoe.

[0038] Figure 23B shows cross section of Figure 23A.

[0039] Figure 24 shows leg of figure 23A for use by diabetic patient.

[0040] Figure 25A shows a cross section of a diabetic foot ulcer with 3D venting fabric spacer and with a venting nipple.

[0041] Figure 25 B shows figure 25 with a threaded venting nipple.

[0042] Figure 25C shows a venting with its cover and internal filter.

[0043] Figure 25D shows insertion and removal of internal filter.

[0044] Figure 26A shows a venting nipple with a sliding filter and cover.

[0045] Figure 26B shows a protective cover made of kork.

[0046] Figure 27A shows a total contact cast assembly with protruded venting sandwiches and with compressible EVA membrane to absorb edema's pressure.

[0047] Figure 27B illustrates Figure 27A. [0048] Figure 27C is a cross section assembly of a ventilated total contact cast of leg of Figure 2 by protruded venting sand- witches as in Figure 29E.

[0049] Figure 27D is a repetition of Figure 27C externally in detail the components of its stepping unit.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] Referring to a diabetic foot ulcer.

FIGURE 1

Figure 1 represents a plantar surface of a foot with a diabetic foot ulcer covered by a wound care dressing as in 1.

[0051]

FIGURE 2

Figure 2 represents a foot having a wound care dressing as in 1 ready to cover its diabetic foot ulcer.

[0052]

FIGURE 3

Figure 3 is a rolled 3D fabric spacer as in FS. Of 3mm.thickness. To be inserted inside a tubular hydrophilic tubinette as in 3.

[0053] Air can penetrate the FS walls and refresh the opened toes walls.

[0054] The tubinette 3 absorbs sweat, bacteria and bad smells.

[0055] The FS and the tubinette as in 3 combined together form a toe separator as in TS capable to be squeezed by the edema pressure and thus relieve the patient's vascular system from further pain and discomfort.

[0056]

FIGURE 4

Figure 4 is the toe separator as in TS in which air as indicated enters the TS vertically and laterally to keep the toes fresh and to absorb the edema pressure exercised between the toes open space.

[0057] The TS contains a rolled 3D fabric spacer as in FS.

[0058] The FS is anchored inside the tubinette 3 by stitches 4.

[0059]

FIGURE 5

Figure 5 shows a foot with an open toe containing a medicated toe separator as in (TS).

[0060] This (TS) has an external layer made of a cotton tubinette as in 3.

[0061] A compressed or rolled portion of a 3D fabric spacer is anchored inside the tubinette 3.

[0062] The toe separator allows air to reach the skin between each toe thus allowing the formation of less sweat, itchiness, bacteria and bad smells.

[0063] The 3D fabric spacer as (FS) is very porous and being compressible it absorbs the edema compression of the foot.

[0064] This reduction of dema or compressive force saves the change for a new immobilizing cast. [0065]

FIGURE 6A

Figure 6A shows a leg as in 2 covered by a tubular stockinette as in 3. The stockinette 3 is folded upwards towards the phalanges at 4.

[0066]

FIGURE 6B

Figure 6B shows a leg as in 2 with a 3D venting fabric spacer as in 7C and as in 7D.

[0067] 7C and 7D are ready to be installed on each lateral side of foot 2.

[0068] Stripes 7C and 7D meet at the Achilles' tendon of the foot. Stripes 7C and 7D can be cut if they are too long.

[0069]

FIGURE 7

Figure 7 shows leg 2 covered by stockinette 3. [0070] A 3D fabric spacer as in 5 to be applied at the tibial portion as in 6.

[0071] Fabric spacer 3D be stretchable as two ways or as four ways to allow a smooth assembly on top of the tibial or calf portions.

[0072] The 3D fabric spacer as in 5 is compressible thus absorbing the edema's painful pressure.

[0073] This absorption of pressure saves the need to change the total contact less frequently.

[0074]

FIGURE 8

Figure 8 shows the leg 2 covered by stockinette 3.

[0075] Toes as in 6 are also covered by stockinette 3.

[0076] Fabric spacer as 5.A covers fully frontal portion of leg 2.

[0077] FIGURE 9

Figure 9 shows the leg 2 and the dorsal 3D fabric spacer as in 5.B ready to be applied on the calf area.

[0078] Dorsal 3D fabric spacer is compressible in order to absorb the edema's compressive force as fabric spacer 5.A.

[0079] 5.A and 5.B are aerating and compressible elements able to dissipate excessive heat, bad smells and bacteria and diminish the edema compressive force.

[0080]

FIGURE 10

Figure 10 shows the dorsal 3D fabric spacer as in 5.B already attached to the calf area of leg 2. This 3D fabric spacer is compressible as the 5.B portion and it has the same benefits of absorbing the edema force.

[0081] FIGURE 11

Figure 11 shows discs 7.A and 7.B made of 3D fabric spacer ready to cover the malleoli of leg 2.

[0082] The 3D fabric spacers as in 7.A and as in 7.B can be 2 or 4 ways stretchable for better installation on top of bumpy ankles.

[0083] 7A and 7B are porous and allow air to ventilate the malleoli.

[0084]

FIGURE 12

Figure 12 shows leg 2 with surgical tape 8A, 8B and 8C anchoring 3D fabric spacers to its frontal and posterior sides.

[0085]

FIGURE 13 Figure 13 shows leg 2 with disc of 3D fabric spacer as in 7B anchored to its left malleoli.

[0086]

FIGURE 14

Figure 14 shows a foot as in F to be covered by a partial 3D ventilating fabric spacer as in 5A.

Air as in 500 reaches the skin of the foot as in F.

[0087] At the plantar surface of foot F there is a flexible sole as in S.

[0088] Sole S can optionally be made of two layers of different hardness with upper layer being softer than the lower layer to add more comfort to the patient.

[0089] Sole S has perforations as in P to transmit air to the foot's plantar surface.

[0090] Sole S lies on top of base B.

[0091] The base B has vertical protrusions as in P.

[0092] The protrusions P are spaced by approximately 3mm. to each other. [0093 Air travels between protrusions P and reaches the plantar surface of the foot F.

[0094]

FIGURE 15

[0094] Figure 15 shows the same parts of figure 14 in an assembled fashion.

[0095]

FIGURE 16 A'

Figure 16 A' depicts a rectangular piece of a perforated hypoallergenic foam as in AF.

[0096] Figure 16 A'" shows this above-mentioned AF part being ready to cover the injured foot as in F.

[0097] Until today this above-indicated pocket as in AF is mistakably coated internally and entirely by an adhesive. [0098] This above indicated entire internal coating is not practical because when the cast gets hot the internal adhesive coating will melt and gazes will be generated thus making the patient uncomfortable.

[0099] Also, this above-indicated coating is an additional and useless manufacturing cost.

[00100] Another, disadvantage consists in having the internal walls of pocket AF, when the fiberglass cast is removed, the internal adhesive coating of pocket AF will stick stubbornly on the venting layers as newly present in Figure 15.

[00101] Also, by considering the total contact cast of Patent Number 9192504 the same unwanted adhesion exists between the cast and between the toes cover.

[00102] To avoid having the above-indicated disadvantages I designed a new AF toes cover as the one depicted inside Figure 16A'. For this purpose my new AF toes cover will have internally a reduced amount of adhesive. [00103] The adhesive will be applied only on the borders of lateral sides of AB, CD and BC thus that all ABC segment forms a "L" letter as seen inside this Figure 16A'.

[00103] The care giver will peel off the above-indicated borders of ABC and create a protective "toes pocket" as in AF by joining internal sides BA to side CD.

[100104] Therefore, by executing this design we will avoid of having unwanted gazes, additional heat and higher manufacturing costs.

[00105] Also, the de casting process will be faster, easier and cheaper.

[00106] In this situation the same "toes cover" could be re-used for recasting the patient's foot or leg for more than one time.

[00107] To solve this problem, I it is suggested to create a new and improved design of an innovative pocket foam with considerably internally less adhesive on it. Therefore, it is visualised to apply a perforated protective "cover toes" without having an internal sticky surface. To achieve such a design it will be needed a foam consisting of a layer of adhesive covered by a release paper as in 200 in the shape of an "L" letter.

[00108] This release liner as in 200 has a uniform longitudinal width as W of 2.0cm.

[00109] Under this above-indicated release liner as in 200 an adhesive layer will be applied in order to help the care giver to stick the internal sides of BA to CD and as expected without sticking the 3D fabric spacers as seen in Figure 15 to this protective toes cover internally.

[00110]

FIGURE 16A"

Shows the wounded foot as in F being placed on top of perforated membrane of foam as in AF.

[00111]

FIGURE 16A'" Figure 1A'" shows the same elements of figure 15 and with a perforated adhesive foam as in AF being ready to cover the foot F with its venting sole S plus its base B.

[00112]

FIGURE 16B

Figure 16B shows leg 2 with mainly frontal and lateral view. It is a continuation of Figure 16A'" The foam adhesive layer as AF is fully anchored to the foot of leg 2.

[00113] Atmospheric air as in 500 penetrates the internal plantar base of the foot and its dorsal side to improve the rehabilitation of the diabetic foot ulcer.

[00114]

FIGURE 17A

Figure 17A shows leg 2 with complete venting elements as in previous Figure 15 to be covered optionally by a surgical elastic net as in SL.

[00115] The net is expanded manually and ready to cover the foot of leg 2. This system is practical and fast. [00116] The surgical nets as in SL could be closed by ultrasonic technologies or sewed at one end to keep the toes well protected.

[00116]

FIGURE 17B

Inside this Figure 17B is a continuation to previous

Figure 17A where the elastic net as SL is fully assembled on the foot.

[00117] The elastic net as in SL keeps the venting devices of Figure 15 in place before the final casting assembly on the leg or on the foot takes place.

[00118]

FIGURE 18A Figure 18A shows a combined venting system to aerate the plantar portion of a wounded foot and optionally to vent the calf of the casted leg of Figure 6A as in 2. [00119] It consist of a flexible sole as in S.

Sole S has holes as in h to allow atmospheric air as in 500 to reach the plantar surface of the foot. This internal ventilation allows the wounded skin to accumulate less heat, smell, bacteria, also, reduced itchiness with edema pressure.

[00120] The sole S is made of a first upper layer as in "a" and of a lower layer as in "b".

[00121] Layer "a" can be made of Shore A 20 or more, capable to withstand the weight of the patient without collapsing into the protrusions "P" of stepping base as in layer B.

[00122] Layer "b" of sole S can be harder than

Shore A 20 in order to protect layer "a" to collapse between protrusions "P" of supportive base B.

[00123] Sole S has ridges as in R to offer more flexibility during its installation under the foot.

[00124] Sole S has ribs as in R to offer the required malleability to the care giver when the total contact cast first layer is applied on the foot's arch.

[00125] Sole S has an adequate unit of compression being big enough to absorb the edema pressure coming from the swollen foot.

[00126] A venting element as in VI made of

3D fabric spacer allows atmospheric air to reach optionally the posterior portion of the leg.

[00127] Regarding element VI, is attached to the rear part of external base B from portion 3.

[00127]

FIGURE 18B

Figure 18B shows a combined venting system as in Figure 18A to aerate the plantar surface of a wounded foot shown as in Figure 6A as part 2. [00128] Under the perforated sole S optionally, an arched support as in SP with two legs as in L alleviates the pressure exerted on the plantar fascia of the foot.

[00129] SP has ventilating holes as in (h) to keep the arch of the foot cool.

[00129] SP optionally can be custom made able to keep the foot less weak, swollen, and inflamed.

[00130] Consequently, the heel won't hurt when standing or walking.

[00131] The arched support SP is a plantar relief pressure and a ventilating tool for the diabetic foot ulcer as in W.

[00132] It positions the foot correctly and promotes proper motion to increase comfort.

[00133] A perforated and solid arch as in SP is anchored on top of base B.

[00134] The above indicated venting system has a base as in B with venting protrusions as in P. [00135] It has ribs as in R to facilitate the total contact cast on the foot's arch.

[00136] Base B is made of a flexible light metal or plastic material used as a strong supportive element to the patient's weight.

[00137] Base B has some flexibility in order to allow it to adapt to the shape of the foot ach during its assembly by the care giver.

[00138] At the back of the base there is mounted by an adhesive as in 3 a vertical venting inlet as in VI made of 3D fabric spacer to allow air to penetrate all around the leg and towards the plantar surface of the foot.

[00139]

FIGURE 19A

Figure 19A shows leg 2 with 3D venting fabric spacer as the frontal portion as in 5A and as with the dorsal portion as in 5B.

[00140] The leg 2 is covered by stockinette as in 3. [00141] The leg 2 has a dorsal venting inlet as VI.

[00142] it has at the plantar surface a sole as in S.

[00143] Leg 2 stands on flexible base as in B.

[00144] Its foot is covered by multi perforated adhesive foam as in AF.

[00145] Air as in 500 penetrates inside the leg 2 from the top portion, from 5A, 7A, 5B and from the sole as in S.

[00146] A 3D fabric ventilating spacer as in 7C covers the lateral side of the foot from the toe to the Achilles tendon.

[00147] A roll of cotton as in C is being ready to cover the leg as in 2.

[00148]

FIGURE 19B

Figure 19B has same venting elements as figure 19A and the phalanges are covered optionally by an expandable net as in SL. [00149] A roll of cotton as in C is ready to cover the leg 2.

[00150] A 3D fabric ventilating spacer as in 7C covers the lateral side of the foot from the toe to the Achilles tendon.

[00150]

FIGURE 20

Figure 20 shows leg 2 fully wrapped by cotton as in C. [00151] Optionally equipped with a frontal venting nipple as in N to allow air as in AIR to enter inside the cotton C and ventilate the leg as in 2.

[00152] A venting system is made in order to allow the plantar surface of leg 2 to be ventilated from the toes and from the Achilles' tendon area.

[00153] Firstly, it consists of a protruded base as in B with protrusions P.

[00154] And secondly it is made of a sole as in S with holes as in H to allow air to reach the plantar surface of leg 2.

[00155] The leg 2 is ready to be anchored on top of venting flexible sole as in S.

[00156] And sole S is ready to be mounted on top of protruded flexible venting base as in B.

[00157] Venting inlet as VI is attached by adhesive 3 to base B.

[00158] In B2 there is a small portion of a venting base with angular protrusions optionally to replace base B.

[00159]

FIGURE 21A

Figure 21A shows wounded leg 2 covered by cotton layer as in C.

[00160] With frontal venting nipple as in N.

[00161] With a plantar venting system as above indicated in previous figure as in 20 made of a protruded venting base as in B and made with a perforated sole as in S. [00162] Equipped with dorsal venting inlet as in VI. Two rolls of immobilizing fiber glass cast as in 6 are ready to cover leg 2.

[00163]

FIGURE 21B

Figure 21B shows the arrangement of total contact cast layers when applied to cure and off-load a diabetic foot ulcer (DFU).

[00164] From first bottom layer there is a diabetic foot ulcer wounded skin with an open wound as in 1.

[00165] From second layer there is a wound care dressing as in 2 usually breathable, hydrophilic and non sticky towards the wound.

[00166] From the third layer there is a cotton hypoallergenic and hydrophilic layer to absorb gases and bad smells as in 3.

[00167] From the fourth layer there is a porous, tubular, expandable stockinette as in 4. [00168] From the fifth layer there is a 3D venting fabric spacer with flexible and compressible polyester threads as in 5. The 3D fabric spacer is as a feather like weight and allows air to travel through it form all directions.

[00169] As for the fifth layer optionally, two layers could be applied on top of each other and each 3D fabric spacer could have a different compression unit.

[00170] This physical property is used to allow the force of the edema pressure to be absorbed by the compressed fabric spacers 5 without exercising a damaging pressure to the patient's vascular system.

[00171] Optionally, compressible EVA or similar materials could be placed under the 5 ^th . layer of fabric spacers.

[00172] 5 ^th . layer of 3D fabric spacers could be made from 2.00mm to 6.00 thick with sufficient elasticity and flexibility to be installed or molded around the curves of a foot, calf, tibia, and malleoli.

[00173] 5 ^th . layer of 3D fabric spacers have openings as in 5 to allow air to travel freely from the outside of the total contact cast to the area of the wound as in 1. Primarily, to facilitate the escape of unwanted heat, germs, smells, bacteria and sweat/exudate via its lateral sides.

[00174] Thus, having an impact on cost compliance and quality of life.

[00175] From the sixth layer there is a combination of immobilizing fiber glass cast.

[00176] The main adverse effects of total contact casts as of today are infection, maceration and abrasion. These above indicated disadvantages happen because the wounded limb is squeezed inside the three immobilizing fiber glass cast layers by the edema force/pressure against the internal walls of the fiber glass cast as in the 6 ^th . layer, therefore, this compressive pressure is absorbed by the compressible 3D layer fabric spacer as in the 5 ^th . layer or and by other compressible layers installed separately in connection of this above Indicated 5 ^th .layer. [00177] A 6 ^th . layer made of three or more layers of fiber glass cast or made of plaster of Paris cast are rolled one by one on each time around the wounded limb to create a total contact cast for absorption of edema and simultaneously for the presence of an active internal ventilation.

[00178] The set of layers of the above indicated figure as in 21A are used for shaping a total contact cast TCC in which one layer covers the tibial area and optionally it could cover the calf and the metatarsals including the malleoli.

[00179] Optionally, a layer of the above indicated figure as in 21Aare used for shaping a total contact cast TCC in which one layer covers the tibial area and optionally it could cover the calf and the metatarsals including the malleoli.

[00180] Optionally, a layer of cotton can be placed between the 6 ^th . layer of immobilizing casts arid between the 5 ^th . layer of the 3D ventilating fabric spacers. [00181]

FIGURE 22

Figure 22 shows a venting plantar unit as in B made of a sole as in S made of soft layer as in (a) and as a harder layer as in (b).

[00182] Sole S has perforations as in "h" as a mean of aeration to the plantar surface of the foot.

[00183] Stepping base C has protrusions as in P to allow air as in 500 to enter between their open channels as in 4 and hit the plantar surface of the foot thus ventilating the foot with a permanent and fresh aeration capable to dissipate unwanted heat, bacteria, and gazes.

[00184] Sole S is compressible thus absorbing the edema's forcing pressure that happens to occur around its elevated external perimeter.

[00185] Also, it shows flexible base as in C. With a venting inlet as in VI with optionally, only one hole at its lower end to allow air to directly ventilate spaces 4 of base C.

[00186] At the stepping base C elevated spikes as in "P" of height 2.0mm to 3.0mm. are formed to withstand the patient's weight.

[00187] The spikes as in P could be arranged indifferent shapes and sizes displaying lozenges, circles, squares, zigzags or combined shapes.

[00188] The ridges as in R give flexibility to sole S and to stepping base C.

[00189] Ridges R allow the plantar surface of the cast to become a solid support to sole S and to stepping base C by supporting the arch of the foot making the foot less weak swollen and inflamed, consequently, the heel will not hurt when standing or walking.

[00190] The ridges and the hardened fiberglass cast are a plantar pressure relief to the DFU.

[00191] Optionally, a stepping arch as in SP could be inserted between the sole as in S and between the layer of the protrusions as in P. The stepping arch as in SP could be custom made. It has venting perforations as in h to allow an added aeration to the plantar surface of the foot.

[00192]

FIGURE 23A

Figure 23.A shows a total contact cast as TCC with immobilizing fiber glass casts as in 6.

[00193] With circulating air as in 500 at the tibial and at the toes locations by means of the nipples existence as in N.

[00194] A venting inlet as in VI allows the posterior side of the leg 2 to be ventilated.

[00195] Under the cast 6 a layer of cotton as in C protects the porous stockinette as in 3.

[00196] Layer of cotton C absorbs odours and vapours from the wounded limb.

[00197] Layer of cotton C facilitates the removal of the cast 6 by not allowing the cast to stick to the stockinette as in 3.

[00198] Internally, between the layer of stockinette as in 3 and between the fiber glass cast as in C there are portions of 3D fabric ventilating spacers as demonstrated by Figures 6B, 7, 8, 9 and 11.

[00199] D represents a walking shoe able to accommodate the total contact casted leg 2.

[00200] D could be replaced by a walking brace to be chosen by the care giver as needed.

[00201] Walking shoe D has an external non slippery rubber slightly compressible sole as in 11.

[00202]

FIGURE 23B

Figure 23B shows leg as in 2. With external pair of casts as in 6.

[00203] With a layer of cotton as in C lying under the casts 6. [00204] With a ventilating 3D fabric spacer as in 4 to cover the tibial portion and the upper frontal part of the foot.

[00205] A 3D fabric spacer as in 4 covers the posterior section of the leg as from the calf up to Achilles' tendon.

[00206] A venting semi flat tube as in VI is installed from the upper part of the calf and is extended downwards up to open spaces of protrusions P of stepping base B.

[00207] Air as in 500 enters semi flat tube VI and travels downwards towards stepping base B.

[00208] A tubular and porous stockinette as in 3 covers the whole leg as in 2.

[00209] A 3D layer of fabric spacers as in 4 covers the tibial portion of the leg and upto its phalanges.

[00210] A 3D layer of fabric spacers as in 4 covers the dorsal portion of the leg as well.

[00211] A flattened venting tube as in VI covers the posterior portion of the calf and atmospheric air as in (AIR) is introduced between the protrusions as in P of base B.

[00212] A surgical expandable net as in SL covers the phalanges and partially the heel of foot.

[00213] A perforated sole as in S lies under the plantar surface of the foot for additional aeration.

[00214] A tubular venting nipple as in N is installed in front of the toes and optionally a second nipple as in N is installed at the tibial section of leg 2.

[00215] The nipples as in N could be installed in various locations on the foot or on the leg 2.

[00216] The nipples can be made by different materials as metal or plastics or cork.

[00217]

FIGURE 24

Figure 24 shows the leg 2 of figure 23A installed inside a walking orthopedic shoe as in D. [00218]

FIGURE 25A

Figure 25A this is an assembly of a cast as in 6 on top of an open wound as in W.

[00219] With a 3D fabric spacer as in 5A on top of a tubular stockinette as in 3.

[00220] With a ventilating nipple as in N.

[00221] Total contact cast can be heavier than normal casts because more than two layers could be applied on injured leg. Therefore, by pure consequence the injured limb will experiment the presence of unwanted heat, itchiness and discomfort.

[00222] To avoid those disadvantages, I suggest implementing to the total contact cast system a protective, controllable and practical apparatus as using venting nipples as previously indicated as in N.

[00223] Inside this Figure as in 25 there is a venting nipple as in N. With a removable pointed cover as in RC with a pointed end as in K. [00224] The cover RC can be removed from the central hole of N by lifting it via handle R.

[00224] Handle R is made of plastic or metallic materials. It can withstand pressure when inserted inside whole H.

[00225] The nipple N has a stem as in A made of plastic by injection molding or machined by a lathe or by 3D printing.

[00226] It has a flat base or head as in C.

[00227] Under the C lies a peelable adhesive layer as in 300 supposed to be anchored on the cotton layer as in 100 before applying the fiberglass rolls around the limb.

[00228] A piercing cover as in K is removed from nipple N.

[00229] Cover K perforates the wet cast 6 during the casting procedure.

[00230] K has a whole to allow its removal via handle R when needed. [00231] Figure 25A shows venting nipple N surrounded by fiber glass casts layers as in 6.

[00232] Nipple N has a base as in C with adhesion base as in 300.

[00232] Being adhered on top of a cotton layer as in 100.

[00233] The 100 layer to cover the 3D venting fabric spacer as in 5A.

[00234] Under the 3D fabric spacer lies a hypoallergenic cotton layer to protect the skin by absorbing sweat and to offer a simple and comfortable cushioning surface to the casted limb.

[00235] Finally, all the above stated elements protect and aerate the open diabetic ulcer as in W.

[00236]

FIGURE 25B

Shows the same figure of 25A but in this case the nipple N internally, is threaded as in T. [00237] This feature will help in not loosing the cover RC.

[00238]

FIGURE 25C

Shows the same venting nipple of Figure 25A by having inside its center hole as in B incorporated a threaded filter as in F.

[00239] The removable and medicated filter F can be cleaned or exchanged for a new one. This is a protection against viruses, water, humidity, insects and new microscopic lethal particles.

[00240]

FIGURE 25D

Depicts the same nipple as in N of previous Figure as in 25B with an additional filter inserter and removable tool as in Fl.

[00241] This Fl tool will be used when existing filters as in F will be in need for further replacement. [00242]

FIGURE 26A

This figure depicts same elements of figure 25D and it shows an internal filter as in F inserted inside the nipple N as in B.

[00243]

FIGURE 26B

Figure 26B shows an opened venting nipple as in N.

As above stated, it is anchored to the cotton layer as 100 via the adhesive as in 300.

[00243] Bottom of nipple N has venting perforations as in "P" to allow the escape of accumulated heat and smells from inside the cast.

[00244] The head C must be circular with a diameter of 3.00mm to 4.00mm in order to be solidly anchored on the cotton as in 100 layers around certain selected parts on the wounded limb.

[00245] The fiber glass casts layer could be applied by more than two layers.

[00246] The 3D fabric spacer as in 5A is compressible and it can store the compression force coming from the edema's limb without exercising any unwanted pressure on the injured limb.

[00247] The wound as in W expels heat, bad smells and gases that all of them exit the total contact cast via the central hole as in B of the nipple as in N.

[00248] Figure 26A depicts the above indicated nipple as in previous figure as in 25 and inside this Figure 26A there is on top of the nipple N a removable cover to be used when less ventilation is required or for protection against wet conditions.

[00249] The removable cover could be made of a semi- soft material as cork.

[00250] FIGURE 27 A

Shows the diagram of a diabetic ulcer as in W.

[00251] A triple layer of fiber glass cast as in C constitutes a total contact cast to offload the patient's weight on the injured limb.

[00252] The immobilizing casts as in C cover the whole area of the foot or leg.

[00253] Casts C are installed on top of hydrophilic medical cotton layer as in 2.

[00254] Cotton layer as in 2 separates layer C from EVA perforated, venting layer 3. Similar polymers as EVA could be used.

[00255] So far it was explained that the wounded ulcer or casted skin it could be vented or aerated via 3D fabric spacers but this above indicated aeration could take place by adding optionally a venting system by using a pair of perforated EVA layers as in this Figure 27A.

[00256] As from the bottom, the first layer as in 4 to have protrusions as in 6 and between each protrusion with grooves as in 7. [00257] The grooves as in 7 allow more flexibility during its installation on top of curved shapes around the leg and the foot.

[00258] Layer 4 having perforations as in 5 and second layer as in 3 with perforations as in P.

[00259] Atmospheric air as in 500 to travel between protrusions 6 and reach the wound as in W.

[00260] The wound W is medicated by a wound care dressing as in WD the skin as in 8 to be covered by hypoallergenic cotton as in 9.

[00261] In C there is fiberglass cast layers as in C and underneath C a cotton layer as in 2 to avoid the cast C to stick to the venting EVA layer as in 3.

[00262] Layer 3 is of thickness as 15 mm to 20 mm in order to be able to be compressed when the foot or leg is/are excessively swollen by the edema pressure.

[00263] By having layer 3 of such thickness as 15 mm to 20 mm instead of a normal thickness as 2 to 3 mm this won't allow the cutting cast saw machine to wound or injure the leg/foot during the de casting procedure by the care giver.

[00264] The upper EVA membrane as in 3 to be made of a very low hardness as 15 Shore A could be easily squeezed by the compressive edema force without suffocating the wounded limb by causing any vascular problems.

[00265] The soft EVA layer as in 3 is installed on top of a protruded layer as in 4.

[00266] Layer 4 has a higher hardness than layer 3 in order to protect its protrusions as in 6 from collapsing. [00267] That hardness could reach 25 Shore A or more.

[00268] Air as in 500 travels between the protrusions as in 6 and ventilates the diabetic foot ulcer as in W.

[00269] Mixed harnesses of layers 3 and 4 save the limb from being suffocated by the edema pressure and offer a healthy environment for a quicker recovery. [00270] A tubular expandable stockinette as in ST transfers gazes and odours to the outside of the cast via EVA layers 3 and 4.

[00271] The diabetic foot ulcer is medicated and protected by wound care dressing as in WD.

[00272]

FIGURE 27B

Figure 27B is an illustration of previous Figure 27A.

With first upper EVA layer as in 3 and with second EVA layer as in 4.

[00273] With perforations as in P to ventilate internally the fiber glass cast walls and the cotton wrapping layer that lies under the fiber glass cast related to" Figure 27 as in 2.

[00274] The second EVA layer of the above indicated Figure as in 27B is described as a scrab view in which it is indicated a serie of thermoformed protrusions as in 6. [00275] Second layer as in 4 has venting perforations to transfer atmospheric air internally towards the wounded foot or leg.

[00276] Between the protrusions as in 6 there are grooves as in 7 in order to give to the EVA layer more flexibility as needed during installation of device around the patient's limb.

[00277] Air as in 500 travels between protrusions 6 vertically and horizontally and reaches the patient's skin via its holes as in 5.

[00278] Layers 3 and 4 absorb the edema compressive force and keeps a healthy blood circulation.

[00279] Layers 3 and 4 protect the skin when the oscillating saw during the cast removal.

[00280]

FIGURE 27C

Figure 27C shows a casted leg as in (A) being immobilized by a total contact cast inside three fiber glass casts as in 2.

[00281] Under the casts as in 2 a layer of cotton as in 3 surrounds the whole leg as in (A).

[00282] Cotton 3 is a padding support for the leg (A) and protects the fiber glass cast layer as in 2 from adhering to the venting upper EVA layers as in 4.

[00283] Venting nipples as in N allow air as in 500 to enter inside the immobilized leg A.

[00284] An additional venting system as in 27B attracts more fresh air to dissipate excessive heat, bacteria, viruses, bad smells and reduce the itchiness.

[00285] 27B will absorb the edema pressure as mentioned previously and rehabilitation of DFU will be faster than usual thus allowing the care giver to renew the cast in shorter time and TCC.

[00286] 27B is a scrab view identical to the one inside the previous figure.

[00287] The leg L is covered by a tubular stockinette as in 6ST.

[00288] A toes protector as in C is a removable cover it could be made by a perforated foam as in Figure 16B or it could be made by an expandable net of trade name Surgilast ™ as in Figure 17B.

[00289] A venting perforated sole as in (B) aerates the plantar surface of the foot.

[00290] Under the sole (B) a venting stepping base as in C forwards air as in 500 to the plantar surface of the injured foot.

[00291] The stepping base as in C is fully described or related to previous Figure 22.

[00292] Leg L is ventilated by venting nipples as in N, by protruded EVA layers as in scrap view 27B, by venting toes separators as in Figure 5 and by venting sole B with venting base as in C.

[00293] Leg L is protected by edema internal pressure via its compressible EVA layers as in Figure 27B.

[00294] Leg L is fully protected by oscillating cast cutter during casts removal. [00295] The leg L might be casted also by plaster of Paris.

[00296] The amount of casts layers will depend on the types of wounds and on the types of brands available now a and in the future.

[00297]

FIGURE 27D

Figure 27D is a replica of Figure 27C it is a cross section view of a total contact cast of leg L.

[00298] Optionally, elements of Figure 18A could be added in order to add more air as in 500 via element VI.

[00299] Also, optionally, a venting arched support as in SP could be added to the venting stepping base (C) to enhance the product characteristics if needed.

[00300] Arched supports as in SP have perforations to ventilate the plantar base.

[00301] SP come into a variety of shapes. SP could be custom made if deemed necessary. [00302] SP could be made of a variety of mixed materials as metals, alloys, plastics, organics, foams, felt, cork, and sponges.

[00303] A stepping base as in (C) supports the patient's body weight.

[00304] Base (C) has protrusions as in "P" being distanced by 2mm to 3mm.

[00305] Air flows between such distance thus allowing the foot to immerse inside a healthy environment.

[00306] At the further back of the stepping base as in (C) optionally, a venting semi flat tube as in VI supplies atmospheric air between open spaces of protrusions as in P.

[00307] Semi flat tube as in VI is applied at the back of the calf and covers the whole calf being extended to the bottom of the foot or near the heel.

[00308] More details are inside Figure 18A.

[00309] Cover C is described in Figure 16A and in Figure 16B a second version of cover C is described in Figure 17A and in Figure 17B. [00310] A diabetic foot ulcer (DFU) lies under cover C, DFU could be present on any portions of a patient's foot or leg.

[00311] A flexible sole as in (B)supports a plantar base of leg L.

[00312] Sole (B) is described previous Figure 18A.

[00313] Sole (B) has perforations as in H to allow the atmospheric air to reach and ventilate indirectly the wounded plantar surface of the foot thus preserving a cool and fresh environment.

[00314] This method will minimize the accumulation of unwanted heat by providing more comfort accompanied by less sweat, smells, bacteria and gases. [00315] Sole (B) is made of an upper layer as in "a" and with a lower layer as in "b".

[00316] Layer "a" is optionally and partly covered by a clear gel cushion to add maximum comfort and equilibrium to the patient. References Cited

U.S. PATENT No.: 6,974,431 B2

Filed: Apr. 24, 2003

Related U.S, Application Data

Provisional application No. 63/204,147, filed on Sep.16, 2020, provisional application No. 63/204,612, filed on Oct. 15, 2020, provisional application No.: 63/207,147, filed on Sep.16, 2020, provisional application No.: 63/258,668, filed on May 20, 2021, provisional application No.: 63/258,747, filed on May 27, 2021.