BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention relates to a customizable insole for a user with diabetic foot ulcers. More specifically, the present invention is directed to a customizable insole for diabetic users where the insole can be quickly customized by the user themselves by removing perforated areas of the insole to offload a portion of a foot without trial and error and undue efforts.
2. Background Art
U.S. patent Ser. No. 10/172,413 to Chanda (Hereinafter Chanda) discloses insoles useful for treating skin injuries on a foot, for instance ulcers. The insoles are customizable for each patient's foot and can include various portions of differing softness, depending on the needs of the patient. For instance, it can be beneficial for certain sections of the foot to contact a firmer material, whereas other sections contact a softer material. Some, or all, of the materials can include one or more biofidelic skin simulant materials. Thus, various implementations include one or more regions that can include the same or different materials. For example, a custom insole can include a heel support region, a midfoot support region, and a forefoot support region, and the support regions can be subdivided into medial and lateral support regions or toe regions. One or more regions may have a custom isolation segment to prevent the progression of ulcers and/or expedite wound healing.
According to Chanda, over 20 percent of the 400 million diabetic patients all around the world have foot ulcers. Foot ulcers can be caused by loss of circulation and sensitivity of the skin on the foot, consequently leading to its embrittlement and vulnerability to cracking. The most common sites for occurrence of a foot ulcer are the high pressure points namely the toes, metatarsals, arch, and the heel. An offloading boot can be used to walk with a toe ulcer, as it redistributes the foot pressure onto the heel with minimal pressure transmitted to the toe. However, often, excessive heel pressure may cause the development of heel ulcers. The only technology available in the market for heel ulcers is a total contact cast (TCC) or a plaster. TCCs are also used for toe ulcers that get worse (in terms of size and healing) with time. In some cases, ulcers are also observed at the arch of the foot, which can also be covered using a TCC. The most common issues with both the offloading boot and the TCC are reduced mobility, the requirement of wound dressing on a daily or weekly basis, and slow wound healing (due to all time encapsulation of the ulcers and no contact with the atmosphere). If not taken care of, the ulcers can require a foot amputation. The current treatment for foot ulcers is the V.A.C (Vacuum Assisted Closure), in which the patient must either sit in a wheelchair or is confined to bed rest. Currently, patients with foot ulcers have no way to continue leading their normal life, go to work, socialize or perform their regular activities. Also, besides physical trauma, there is a huge amount of mental trauma which these patients often go through. Current products focus on prevention of diabetic ulcers rather than their cure and management. The technologies invented for the treatment of diabetic ulcers were mostly in the form of bandages and protective ulcer enclosures which hinders patient mobility. Ulcer isolation has been explored in combination with a TCC, however, the drawbacks associated with TCC persist.
Although Chanda demonstrated customized insoles, there remains a need for customizable insoles that lend themselves to customizations that can easily be performed by the users themselves without undue efforts.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a customizable insole for a user, the customizable insole including:
- (a) an insole, the insole including at least one layer;
- (b) at least one perforated area disposed on the insole,
wherein the at least one perforated area of the insole can be removed by following the perforation surrounding the at least one perforated area, the at least one removed perforated area of the insole is configured for offloading a foot of the user at the at least one removed perforated area of the insole. In one embodiment, the at least one layer is constructed from Closed Cell Foam, Micro Cellular Rubber (MCR) or Ethylene Vinyl Acetate (EVA). In one embodiment, the at least one perforated area includes an area corresponding to a toe area of the user. In one embodiment, the toe area further includes at least one digit area corresponding to a digit and a great toe area corresponding to a great toe. In one embodiment, the at least one perforated area includes an area corresponding to a metatarsal area of the user. In one embodiment, the metatarsal area further includes at least one metatarsal area corresponding to a lateral metatarsal, a middle metatarsal and a medial metatarsal. In one embodiment, the at least one perforated area includes an area corresponding to an arch area of the user. In one embodiment, the arch area further includes at least one arch area corresponding to a lateral arch, a middle arch and a medial arch. In one embodiment, the at least one perforated area includes an area corresponding to a heel area of the user. In one embodiment, the at least one layer includes two layers. In one embodiment, the two layers are bonded by way of an adhesive. In one embodiment, the two layers are constructed from different materials. In one embodiment, the two layers are constructed in different thicknesses.
An object of the present invention is to provide a customizable insole which reduces the amount of efforts required to customize the insole for a patient's foot.
Another object of the present invention is to provide a customizable insole where any conceivable locations requiring offloading can be readily customized.
Another object of the present invention is to provide a customizable insole that lends itself to customizations that can easily be performed by the users themselves without undue efforts.
Another object of the present invention is to provide a customizable insole with perforated areas of the insole that can be easily removed by following the perforations surrounding the perforated area, to offload the foot of a user without guesswork or trial and error.
Another object of the present invention is to provide a customizable insole where perforated areas to be removed to offload the foot of a user are quickly identified.
Another object of the present invention is to provide a customizable insole with layers of perforated areas that can be easily removed by following the perforations surrounding the perforated area, to offload the foot of a user where severe ulcerated areas of the foot may require multiple areas on the layers to be easily removed.
Whereas there may be many embodiments of the present invention, each embodiment may meet one or more of the foregoing recited objects in any combination. It is not intended that each embodiment will necessarily meet each objective. Thus, having broadly outlined the more important features of the present invention in order that the detailed description thereof may be better understood, and that the present contribution to the art may be better appreciated, there are, of course, additional features of the present invention that will be described herein and will form a part of the subject matter of this specification.
BRIEF DESCRIPTION OF THE DRAWINGS
In order that the manner in which the above-recited and other advantages and objects of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
FIG. 1 is a top view of a pair of left and right customizable insoles where the perforated areas of the insole can be removed by following the perforations surrounding the perforated areas, the removed perforated areas of the insole being configured for offloading a foot of the user at one or more removed perforated areas of the insole.
FIG. 2 is a side cross-sectional view of a customizable insole configured with two layers, the bottom layer having been configured with a removed perforated area for offloading a foot of the user at the removed perforated area.
FIG. 3 is a side cross-sectional view of a customizable insole configured with two layers, the top layer having been configured with a removed perforated area for offloading a foot of the user at the removed perforated area.
FIG. 4 is a side cross-sectional view of a customizable insole configured with two layers, the top and bottom layers having been configured with removed perforated areas for offloading a foot of the user at the removed perforated areas.
FIG. 5 is a diagram depicting an insole of FIG. 2 having been used to support a patient's foot.
FIG. 6 is a diagram depicting an insole of FIG. 3 having been used to support a patient's foot.
FIG. 7 is a diagram depicting an insole of FIG. 4 having been used to support a patient's foot.
FIG. 8 is a top perspective view of a customizable insole where a section or a perforated area of the top layer has been removed.
FIG. 9 is a top view of another embodiment of a perforated portion of a customizable insole where at least a portion of the interfaces between perforated portions of the customizable insole include interlocking interfaces.
FIG. 10 is a side cross-sectional view of a customizable insole configured with two layers, the top and bottom layers having been configured with removed perforated areas for offloading a foot of the user at the removed perforated areas while a section on the top layer has been removed to accommodate a replacement section that is thicker.
PARTS LIST
2—insole
4—perforated line
6—toe area (digits 2-5 and great toe)
8—metatarsal area (lateral, medial, and middle)
10—arch area (lateral, medial, and middle)
12—heel area
14, 16, 18, 20—perforated toe areas
24, 30—perforated lateral metatarsal areas
22, 28—perforated middle metatarsal areas
26, 32—perforated medial metatarsal areas
36, 42, 48, 54—perforated lateral arch areas
34, 40, 46, 52—perforated middle arch areas
38, 44, 50, 56—perforated medial arch areas
58, 60, 62, 64—perforated heel areas
66—foot
68—space left by removed perforated area
70—protrusion
72—replacement section
Particular Advantages of the Invention
The present insoles can be easily customized according to a patient's needs as perforated areas of the insoles on each layer of the insole have been pre-determined and perforated areas to be removed to offload the foot of a user are quickly identified without guesswork or trial and error. This reduces the amount of efforts required to customize the insole for a patient's foot and any conceivable locations can be readily customized by the users themselves without undue efforts. Severe ulcerated areas of the foot may require multiple areas on the layers to be easily removed.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
The term “about” is used herein to mean approximately, roughly, around, or in the region of. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20 percent up or down (higher or lower).
FIG. 1 is a top view of a pair of left and right customizable insoles 2 of, e.g., a pair of shoes or walker boots, for a diabetic foot patient. The customizable insoles are shown divided by perforated lines 4 into removable perforated areas where the perforated areas of the customizable insole can be removed by following the perforations surrounding the perforated areas. Each customizable insole includes an insole having at least one layer and at least one perforated area disposed on the insole. Each perforated area can be removed by using a tool, e.g., a tool with a sharp edge and/or tip which can be inserted along the perforations surrounding the perforated area to sever the connecting material afforded by the perforations to separate the perforated area from an insole. Each perforated area may alternatively be separated from an insole by bending the insole along a perforated line before applying a prying force, e.g., with a tool or one or more fingers. The removed perforated areas of the insole are configured for offloading a foot of the user at one or more removed perforated areas of the insole associated with the toes, metatarsals, arch, and heel of the user's feet. The inventive concept of the present customizable insole lies not in the shape of the perforated areas, but rather in the ease with which the user can remove areas to offload troublesome painful portions of their foot without undue efforts involving guesswork or trial and error. In one embodiment, the at least one perforated area includes an area corresponding to a toe area of the user. In one embodiment, the toe area further includes at least one digit area corresponding to a digit and a great toe area corresponding to a great toe. In one embodiment, the at least one perforated area includes an area corresponding to a metatarsal area of the user. In one embodiment, the metatarsal area further includes at least one metatarsal area corresponding to a lateral metatarsal, a middle metatarsal and a medial metatarsal. In one embodiment, the at least one perforated area includes an area corresponding to an arch area of the user. In one embodiment, the arch area further includes at least one arch area corresponding to a lateral arch, a middle arch and a medial arch. In one embodiment, the at least one perforated area includes an area corresponding to a heel area 12 of the user. The patient's doctor can provide the patient with a description of the location of their foot ulcer that can be used by the patient to easily identify the perforated areas that need to be removed.
Referring again to FIG. 1, the four areas 14, 16, 18, and 20 in section 6 include the toe areas for toe digits 2 through 5 and the great toe. The six areas 22, 24, 26, 28, 30 and 32 in section 8 include the metatarsal areas where areas 24 and 30 include the lateral metatarsal areas, areas 22 and 28 include the middle metatarsal areas, and areas 26 and 32 include the medial metatarsal areas. The twelve areas 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54 and 56 include the arch areas where areas 36, 42, 48, and 54 include the lateral arch areas, areas 34, 40, 46, and 52 include the middle arch areas, and areas 38, 44, 50, and 56 include the medial arch areas. The four areas 58, 60, 62 and 64 include the heel areas.
In one embodiment, the customizable insole can be constructed from Closed Cell Foam, Micro Cellular Rubber (MCR), Ethylene Vinyl Acetate (EVA) or any combinations thereof. The two layers need not be made from the same material, e.g., the top layer may be made from a softer material as it is the layer which normally comes in direct contact with an individual's foot. The material used for the insole construction should have sufficient stiffness to provide support and cushioning to offload the foot of a user, have wear properties to resist abrasion and continuous use, have thermal properties to keep the user's foot from overheating, be moisture absorbent, be anti-microbial, be hypo-allergenic, and be economical. The insole material needs sufficient stiffness to adequately support a diabetic foot at the periphery of a protrusion after a perforated area of the insole has been removed for offloading the protrusion. The insole stiffness should not decrease over time with use to the point where the protrusion begins to adversely contact the hard shoe sole and experience a reduction of the offloading intended by the insole. Repeated cycles of compression and shear during walking should not degrade the stiffness or wear and abrasion resilience of the insole material with continuous use. The insole material needs to be moisture absorbent to keep the user's foot cool and comfortable without sweating during warm weather and yet be warm and comfortable in cold weather. Sweating should be avoided which can grow microbes on the patient's skin causing odor. The material needs to be anti-microbial to reduce the risk of infection when foot ulcers are present. It is important to prevent aggravating a foot ulcer that may lead to an eventual amputation, as foot ulceration is known to precede 80% of all diabetic lower limb amputations according to Chanda. The insole material should be hypo-allergenic to avoid triggering an allergic reaction by the user. The insole material also needs to be economical so that the insole can be made readily available to a wide population of users with a limited range of financial resources at their disposal. In addition, different portions of the insole will require material of different softness according to the needs of the contacting portions of the foot in those areas, and biofidelic skin simulant insole materials should be used simulating the non-linear viscoelastic biomechanical properties of human skin according to Chanda.
In one embodiment, each customizable insole includes two layers 4, 6, both of which include similar and matching perforated areas disposed atop on another. In one embodiment, the two layers are bonded by way of an adhesive. In another embodiment, the two layers are bonded without adhesive, e.g., by means of thermoplastic moulding as a result of heat and pressure. The bonding should keep the two layers in contact during use, but not be too difficult to break in order to allow the user to easily remove perforated areas without undue efforts. The loading during use, as a result of the user's foot standing on the insole, will be a compression of the insole material. The two layers should remain in contact and not separate along the interface of the two layers due to this compression. During walking, the two layers will be in shear causing the two layers to slide with respect to each other along the interface between the two layers. The two layers need to stay bonded together and not separate along this interface as a result of this shearing effect. The bonding must be strong enough to keep the two layers together during use but not so strong that it is difficult to remove perforated areas under the user's or an individual's own strength. The bonding should still be strong enough to permit perforated areas to be re-attached to the insole after having been removed by the user, as the user removes and re-attaches perforated areas during the customizing process to find the best configuration for offloading their diabetic foot.
FIG. 2 is a side cross-sectional view of a customizable insole configured with two layers 4, 6, the bottom layer having been configured with a removed perforated area 68 for offloading a foot of the user at the removed perforated area.
FIG. 3 is a side cross-sectional view of a customizable insole configured with two layers 4, 6, the top layer having been configured with a removed perforated area 68 for offloading a foot of the user at the removed perforated area.
FIG. 4 is a side cross-sectional view of a customizable insole configured with two layers 4, 6, the top and bottom layers having been configured with removed perforated areas 68 for offloading a foot of the user at the removed perforated areas.
FIG. 5 is a side cross-sectional view of an insole of FIG. 2 having been used to support a patient's foot 66 where the bottom layer has had a perforated area removed to offload a painful protrusion 70 of the user's foot 66. The top layer of the customizable insole has not been altered in order to provide some cushioning for the protrusion. This is a case of least severe care where the size of the protrusion is significant and painful but relatively small compared to the range of protrusions commonly suffered by diabetic foot patients.
FIG. 6 is a side cross-sectional view of an insole of FIG. 3 having been used to support a patient's foot 66 where the top layer has had a perforated layer removed to offload a painful portion or protrusion 70 of the user's foot 66. The bottom layer of the customizable insole has not been altered and provides some cushioning for the protrusion. The protrusion in this case is larger than that shown in FIG. 5 but not as large as some diabetic users encounter.
FIG. 7 is a side cross-sectional view of an insole of FIG. 4 having been used to support a patient's foot 66 where two adjacent disposable areas in the top and bottom layer have been removed to offload a severely large, painful, troublesome, and perhaps ulcerated portion 70 of a user's foot. The size of the protrusion shown here exceeds that shown in FIGS. 5 and 6. The user has the option to quickly try each of the options shown in FIGS. 5, 6, and 7 to see which of the options are best and most comforting.
FIG. 8 is a top perspective view of a customizable insole where section 28 of the top layer has been removed. It is apparent from FIG. 8 that removing section 28 may potentially threaten the integrity of the customizable insole since there is little material left in section 8 to connect it to section 10. In one embodiment, the bottom layer is not perforated and serves as a unifying layer when multiple perforated areas of the top layer have been removed. For example, if portions 30, 28, and 32 are removed from the top layer, the integrity to the insole will still be maintained if the remaining portions of the top layer are sufficiently attached to the non-perforated bottom layer. This allows the user to remove multiple adjacent portions of the top layer without undue concern.
FIG. 9 is a top partial view of another embodiment of a perforated portion of a customizable insole where detail A shows that perforation lines 4 are configured as serrations in the form of “teeth” that are in the shape of sine waves with a cycle period of about ½ inch. The intent here is to keep adjacent removable perforated areas from sliding with respect to each other during use and to make the removable perforated areas easier to detach and re-attach if necessary. The ease in re-attaching removable perforated areas allows the user to try various combinations of removing disposable areas in the top and bottom layer to offload a severely large, painful, troublesome, and perhaps ulcerated portion of a user's foot. In another embodiment, the teeth are in the shape of triangular saw blade teeth. In another embodiment, the perforated lines 4 in the shape of teeth are deployed at only the sharp corners of a perforated portion of a customizable insole. In another embodiment, the perforated lines 4 in the shape of teeth are deployed along the entire periphery of a perforated portion of a customizable insole. Some diabetic foot patients use an orthotic arch profile to increase the contact with the plantar surface of the foot allowing distribution of force over a greater area of the foot so plantar foot pressure is reduced and so is the pressure on a painful protrusion. The arch profile inserted or removed by the user can be used in combination with removal of perforated areas to find the optimal configuration to allow the offloading of a diabetic protrusion with minimal efforts.
FIG. 10 is a side cross-sectional view of a customizable insole configured with two layers, the top and bottom layers having been configured with removed perforated areas for offloading a foot of the user at the removed perforated areas while a section on the top layer has been removed to accommodate a replacement section 72 that is thicker to provide increased support to an area of the foot, e.g., the arch area of the foot 66. In one embodiment, any one of the layers 4, 6 of the customizable insole can be made in a suitable thickness, e.g., about 0.25-0.75 inch. The two layers need not be constructed in the same thickness. In one embodiment, the layers 4, 6 may be provided unbonded such that a replacement section, e.g., the one 72 shown in FIG. 10 may be obtained more easily from a sacrificial layer 4, 6 to then be inserted and secured in the top layer 4 of the customizable insole shown.
The detailed description refers to the accompanying drawings that show, by way of illustration, specific aspects and embodiments in which the present disclosed embodiments may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice aspects of the present invention. Other embodiments may be utilized, and changes may be made without departing from the scope of the disclosed embodiments. The various embodiments can be combined with one or more other embodiments to form new embodiments. The detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims, with the full scope of equivalents to which they may be entitled. It will be appreciated by those of ordinary skill in the art that any arrangement that is calculated to achieve the same purpose may be substituted for the specific embodiments shown. This application is intended to cover any adaptations or variations of embodiments of the present invention. It is to be understood that the above description is intended to be illustrative, and not restrictive, and that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Combinations of the above embodiments and other embodiments will be apparent to those of skill in the art upon studying the above description. The scope of the present disclosed embodiments includes any other applications in which embodiments of the above structures and fabrication methods are used. The scope of the embodiments should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Patent Application
20240324722
