|Publication number||USRE40363 E1|
|Application number||US 09/592,462|
|Publication date||Jun 10, 2008|
|Filing date||Feb 16, 1994|
|Priority date||Feb 16, 1993|
|Also published as||CA2155346A1, DE69430733D1, DE69430733T2, EP0686005A1, EP0686005A4, EP0686005B1, US5329705, US5761834, WO1994018863A1|
|Publication number||09592462, 592462, PCT/1994/1797, PCT/US/1994/001797, PCT/US/1994/01797, PCT/US/94/001797, PCT/US/94/01797, PCT/US1994/001797, PCT/US1994/01797, PCT/US1994001797, PCT/US199401797, PCT/US94/001797, PCT/US94/01797, PCT/US94001797, PCT/US9401797, US RE40363 E1, US RE40363E1, US-E1-RE40363, USRE40363 E1, USRE40363E1|
|Inventors||Tracy E. Grim, Kevin O'Donnell, Eric G. Montag|
|Original Assignee||Ossur Hf|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (26), Referenced by (34), Classifications (31), Legal Events (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation-in-part of U.S. patent application Ser. No. 08/017,818, which was filed Feb. 16, 1993 now U.S. Pat. No. 5,329,705. This invention is related to that disclosed in U.S. patent application Ser. No. 07/965,750, filed Oct. 23, 1992, (Docket No. 88-182), entitled “Orthopaedic Support and Method for Providing Semi-Permanent Relief Zones,” assigned to the assignee of this invention.
This invention relates to footgear having orthopaedic soles providing pressure relief areas for the feet.
The problems solved by the present invention were discussed at length in the prior patent application cited above, and the background section of that application will therefore be repeated here.
Support pads are used in a wide variety of applications to provide cushioned support to an injured or otherwise sensitive bodily appendage. Such pads have the dual purpose of (1) providing orthopaedic support to the appendage and (2) protecting the appendage from further injury or damage resulting from contact with a foreign object or hard surface.
One common use of a support pad is as a cushioned foot sole in specialized footwear such as soft boots or patient walkers. These devices generally employ some type of soft, resilient material, such as foam, to provide cushioned support of a sensitive or damaged foot.
A particular problem arises when it becomes necessary to provide uneven support across the outer surface of an appendage. For example, an ulcerated appendage, often found in diabetic patients, requires pressure relief to the ulcerated area to allow healing. In this instance, it is desirable to have a pad which will apply cushioned support to the appendage, while refraining from supporting the afflicted area. For diabetic patients, the feet are commonly beset with such ulcerations, and it is therefore desirable to provide a cushioned support sole for a shoe or walker which is capable of providing specific zones of pressure relief.
Other approaches have addressed the problem of providing cushioned foot support. U.S. Pat. No. 2,598,217 (Bronson), issued May 27, 1952, discloses as invalid's boot with a thick insole. However, these approaches require replacement of the sole for each new patient, or for each new area of the original patient's foot which must be relieved.
Andrews U.S. Pat. No. 4,793,078 discloses a footwear insole with a molded arch support. The insole has either three indentations or a single banana-shaped indentation arranged in an arc behind the toes, and another indentation at the heel. A user may adhesively fix pad inserts into one or more of the indentations to provide support to the foot. The user omits inserts from selected indentations to relieve pressure on certain area of the foot.
Unfortunately, a number of problems arise when diabetes patients, who are prone to severe foot ulcers, attempt to use the Andrews device. Before discussing these deficiencies, however, it is useful to review the foot problem that many diabetes patients face. It is well known that diabetes patients are prone to foot ulcers. In fact, lesions of the foot are responsible for more than one-fifth of the hospitalizations of diabetic patients. More than 40% of the lower extremity amputations in the United States are performed on diabetic patients who have poor circulation in the lower limb. With reduced sensation in the foot, the patient is unlikely to feel discomfort when the skin is subject to shear forces during walking, and consequently he or she does not properly adjust his or her gait. Lesions are formed or are made worse.
Diabetes patients also experience other extreme difficulties with their feet. Diabetic patients often undergo an unfortunate evolutionary pattern of anatomical deterioration. Initially, the foot will have a normal appearance and will only have vascular or neuro-vascular deficiencies. However, the bone structure can quickly deteriorate. Charcot joints can form, and the foot becomes drastically deformed. From then on, the areas of the foot that can bear weight are abnormal, their locations are unpredictable, and custom foot accommodations will be required for the remainder of the person's ambulatory life.
The Andrews device does little to overcome these problems. Foot ulcers and bone deterioration can occur anywhere on the foot, yet Andrews provides only a few pads in very specific locations. The Andrews fixed-location pad arrangement cannot provide pressure relief to damaged areas of the foot that are located anywhere except the four specific pad locations. This makes Andrews inadequate for the majority of diabetes patients with damaged feet.
An additional drawback of the Andrews pad is that it lacks means to reduce shear forces on the skin of the foot that arise as the patient walks along. Such shear forces can further damage existing ulcers, or create new ulcers. This is particularly true where the patient walks for any distance.
Other deficiencies of Andrews are apparent. As shown in Andrews FIG. 1, the Andrews sole is limited to either a left or right foot-only sole. The same Andrews sole cannot be used on either foot because sole support 16 is built into the shoe.
U.S. Pat. No. 3,760,056 (Rudy), teaches a method for conforming a ski boot to the foot of the wearer by heating an inflatable bladder, distending it to the desired shape, and then cooling and deflating the bladder. The bladder can be subsequently be re-inflated to fit the wearer's foot. This method requires a mechanism for heating, which may be inconvenient or impractical when applied to a comfortable sole. In the method disclosed, the inflatable bladder was placed over the foot to contact opposing sides, rather than underneath it as a support. Moreover, the elastomeric materials described in the Rudy patent typically may not provide the requisite comfort and cushioning generally required in a healing device.
A further method of providing support to an injured foot is disclosed in U.S. Pat. No. 5,078,128 (Grim, et al.) in which a removable leg walker includes a plurality of inflatable and adjustable bladder members in order to provide variable amounts of pressure to an affected limb as leg swelling increases or decreases. However, the bladder members of the Grim device do not retain their shape except as restrained by the surface of the appendage itself and thus do not provide the desired semi-permanent areas of relief to an injured appendage.
Incidentally, the above-cited U.S. patent application Ser. No. 07/965,750 discloses arrangements which provide relief using a pad of particulate material which is vacuum formed to the desired configuration.
From an overall standpoint, a principal object of the present invention is to provide a comfortable cushioned sole which may be conveniently modified to provide pressure relief to specific areas of the wearer's foot.
Another important object of the invention is to furnish a device which may be reused to provide relief to different areas of the patient's foot, or which may be used by other patients.
A further object is to provide a method for comforting a cushioned sole to the foot of a particular wearer, and of later reforming or returning the sole to its original shape.
In accordance with one illustrative embodiment of the invention, a walker frame, including an outer sole and side struts may be provided with an air bladder mounted above the outer sole, and a special inner sole mounted above the bladder and made up of a large number of separate resilient sections removably secured to a flexible sheet to form a substantially flat surface for engagement by the foot. In areas where the foot is ulcerated or otherwise injured, sections of the inner sole are removed to provide pressure relief.
In accordance with a broader aspect of the invention, footgear or footwear generally may be provided with an inner sole having mobile sections of the type described in the preceding paragraph.
With regard to the walker embodiment, a flexible soft goods-type support may be provided, to enclose the patient's foot, and having arrangements for securing to the walker frame. The bladder may be mounted between the outer sole and support, layered within the soft goods support, or preferably above the soft goods support. A dorsum strap may be secured to the support or the inner sole and extend around the ankle and instep, to hold the foot in place on the inner sole.
Additional features of the invention may include the following:
Other objects, features and advantages of the invention will become apparent from the following detailed description and from the accompanying drawings.
Referring more particularly to the drawings,
Incidently, with regard to the detailed construction of the walker frame, reference is made to U.S. Pat. No. 5,078,128, granted Jan. 7, 1992, and assigned to the assignee of the present invention.
One of the straps 28 is also visible in
Within the side walls of the soft goods body member 20, may be air bladders such as that shown at reference numeral 38 in FIG. 4 and preferably containing a layer of open cell foam 40. The bladder 38 may be located between one layer of foam 36 and fabric 22 and the second layer of foam 37 and fabric 24. This arrangement provides additional cushioning for the lower leg of the patient, particularly in the vicinity of the struts 16.
The footgear of the present invention is provided with an inner sole assembly 52 which is preferably mounted within the soft goods support member 20 by a layer of hook type securing material 54 which is on the lower surface of the assembly 52, and which engages the inner surface of the soft goods type support member 20 in the area 56 as shown in FIG. 2. The rear portion 58 of the inner sole assembly 56 may extend up behind the heel of the patient to cushion this area of the foot; and the straps 60 and 62, formed of soft material and held together by hook and loop type securing arrangements, served to hold the patient's foot back into proper engagement with the inner sole assembly 52.
Inner sole assembly 52 includes a lower air bladder 64 which may contain a layer of foam material, and an upper resilient layer 66 contituting separate removable sections, also known as individually mobile resilient sections, which together form a normally substantially smooth surface for engagement by the foot. These sections are individually removable, as indicated by the sections 68 which are shown removed from the space 70 where they would normally be located to complete the smooth upper surface of the inner sole assembly 52. The concept, as mentioned in the introductory portion of the present specification, is to provide relief to ulcerated or injured portions of the foot, whereby the foot is supported on the adjacent resilient material, with relief provided in the areas where the removable sections have been taken away.
The top surface of bladder 64 may be substantially indentation-free so that the resilient sections may be removed from any location on the grid. The user is thereby not limited to removing insets only from indentations located in a limited number of positions on the side, such as in the Andrews patent discussed in the Background section. Instead, a user of the present invention may remove sections from precisely the desired location.
Note that the individual resilient sections such as the section 68, have hook or loop type securing material 72 on their lower surfaces, and the upper surface of the bladder 64 has mating hook and loop type material for removably securing sections such as section 68 in place to provide a relatively smooth upper surface. Thus, the group of sections 68 may be reinserted and re-secured into the opening 70, and other sections removed, to accommodate different needs, or the problems of another patient. Instead of using hook and loop type securing material as shown in
Concerning the sole 14, in addition to the outer tread portion 78, it may include the upper and lower high strength plastic sheet members 82 and 84 which are interconnected by appropriate ribs 85. At the rear of the sole 14 is a cantilevered area in which resilient foam material 86 is located, so that controlled flexing of the rear heel end 88 of the lower plastic sheet member 84 provides increased cushioning for the patient, against shock to which he or she might otherwise be subjected.
Regarding the bladder assembly 64, it may include a sealed bladder made of thin sheet urethane 92 covered with cloth material 94, and containing an open cell foam layer 96 which may be bonded to the upper or lower surface of the bladder. Between the upper surface of the bladder assembly 64, and the lower surface of the inner sole 66 is a suitable material 98, for removably securing the inner sole 66 to the upper surface of the bladder 64. Material 98 may be hook and loop type material, or pressure sensitive adhesive, as noted hereinabove. The inner sole 66 may be formed of three layers 102, 104 and 106, which are bonded together. These three layers 102, 104 and 106 may be of progressively different softness and resiliency, with the softest and most resilient layer being the layer 102 closest to the foot, with layers 104 and 106 being progressively less resilient and providing somewhat greater support.
It should be noted that bladder 64 is entirely optional. Inner sole assembly 52 may alternatively include a flexible pad rather than bladder 64. The flexible pad may be made of a material such as cloth with which a hook and loop type material can engage.
With regard to the construction of the outer sole assembly 14, it may be formed as described hereinabove in the cited U.S. Pat. No. 5,078,128, or may be of any other desired configuration. The present invention is primarily directed to a configuration of the inner sole, and the precise configuration of the outer sole arrangements may be chosen from many alternatives.
For instance, concentrating resilient sections made of dense material in the midfoot region will help distribute force throughout the surface of the plantar pad during the gait. As with the other embodiments of the present invention, the removable resilient sections are arranged in a grid. The user removes selected resilient sections in order to create a customized pressure relief zone of desired location and dimensions.
Dense material may also be added to specific regions of the foot to absorb energy where needed, such as the heel region or the instep region. These areas may experience high stress and therefore require additional padding.
Alternatively, the midfoot region of the planar pad may be of a denser material than the heel or the forefoot region. Body weight then shifts onto the middle foot area and off of the front and heel portions of the foot. In other words, during the gait the denser material will support the midfoot region, while the heel and forefoot sink into the less dense material. It should be emphasized, however, that the less dense material must be sufficiently dense so as to prevent the foot from hitting the bottom of the pad, which is known as “bottoming out”.
There are at least two other uses for resilient sections having increased density. First, dense resilient sections may be arranged around the perimeter of a pressure-relief area where resilient sections have been removed. The denser sections provide additoanl suport, and serve to prevent the ulcerated area of the foot from bottoming out in the unsupported area.
Second, dense resilient sections may be used to prevent “compression set”, which is a permanent reduction in cross-section arising from constantly stepping down on the material. A denser material is stronger and more durable, and is less likely to become permanently deformed than a less dense material. Consequently, use of resilient sections having increased density can result in increased durability and product life.
Another alternative embodiment uses some separate resilient sections that are taller than other sections. A user may arrange the taller sections to custom fit a foot.
Taller sections can be arranged around an area of pressure relief, as in FIG. 14. This region of taller sections 208 serves two purposes. First, the taller sections raise the foot in the region of the pressure relief area, thereby reducing the chances that the injured area will “bottom out” against the bottom of the pad when the user steps down on the foot. Second, the taller sections carry more weight around the pressure relief area than would shorter sections. Consequently, the region of tall sections 208 of
As noted above, a heavy patient or a patient with a particularly large ulcer may “bottom out” the afflicted area against the bottom of the pad during walking. To prevent “bottoming out”, the user may apply an additional resilient pad having an aperture and an adhesively-backed lower surface. The lower surface adheres to the upper surface of resilient sections surrounding a pressure relief zone. The additional pad provides extra support around the pressure relief area.
The additional pad may have any of a variety of sizes and shapes to accommodate a variety of different ulcer sizes and user weights. The pad may be made of a single-density material, or may have a multi-density layered arrangement consisting of a supple top layer for comfort and a dense lower layer to support body weight. The pad may also be cut into a grid pattern in order to reduce the shear forces on the foot during walking.
Furthermore, the user may choose to apply the additional pad to the plantar surface without removing any removable sections from the pad. For a particularly heavy user, leaving the removable sections in place provides padding beneath the injured area of the foot to further prevent the “bottoming out” that might otherwise occur as the user transfers weight to the injured area of the foot.
With regard to an alternative feature of the present invention, a problem called “window edema” occurs when an area of the body under low pressure is surrounded by an area of higher pressure. Body fluids tend to build up and become trapped in the area of lower pressure. Distal parts of the body, such as the hands and feet, are particularly prone to window edema because the cardio-vascular system typically does not do a good job of retrieving fluids that are far from the heart. The trapped fluids become excellent media for bacteria to grow, thereby causing infections.
Window edema may be a problem for some users of the present invention.
In order to prevent window edema in the present invention, an edema patch amy be provided in the relief area.
The edema patch may be provided with a variety of features, and may be used in ways other than that shown in
As an additional alternative, film 256 may overlie stretch material 242, with adhesive 244 being on the lower surface of stretch material 242. Film 256 and stretch material 242 may be bonded by pressing the film and stretch material together under high pressure. Alternatively, they may be bonded using any of a variety of commercial adhesives. Additionally,
The edema patch provides another benefit to the user. The relief zone has edges that provide a “window” around the afflicted area. The foot may be subject to increased pressure at these edges, which physicians must often scythe to present skin irritation. However, as
The soft goods body member 320 may be held in position within the frame 314, 316, by pads of hook and loop type material on the inner surface of the struts 316. Additionally, straps such as 28 of
Elongated pad 344 is a strip of hook type material. As in the embodiment of
The present embodiment is provided with an inner booty 357 to provide additional means for retaining the foot within the walker. Inner booty 357 is sewn to soft goods body members 320 along seam 351. Elongated hook type pads 347 and 349 engage the inner surfaces of flaps 359 and 361, respectively, to adjustably hold the inner body about the patient's ankle and foot.
The footgear of the present embodiment is provided with an inner sole assembly 352 which is preferably mounted within the soft goods support member 320 by a layer of hook type securing material 354 which is on the lower surface of the assembly 352, and which engages the inner surface of the soft goods type support member 320 in the area 356 and in the area 390 on inner booty 357.
Inner sole assembly 352 includes a lower cloth pad 364 and an upper resilient layer 366 constituting separate removable sections, also known as individually mobile resilient sections, which together form a normally substantially smooth surface for engagement by the foot. These sections are individually removable, as indicated by the sections 368 which are shown removed from the space 370 where they would normally be located to complete the smooth upper surface of the inner sole assembly 352.
Cloth pad 364 may be substantially indentation-free so that the resilient sections may be removed from any location on the grid. The user is thereby not limited to removing insets only from indentations located in a limited number of positions on the sole. Instead, a user may remove sections from precisely the desired location.
The individual resilient sections such as the section 368, have hook or loop type securing material 372 on their lower surfaces, and the upper surface of the bladder 364 has mating hook and loop type material for removably securing sections such as section 368 in place to provide a relatively smooth upper surface. Thus, the group of sections 368 may be reinserted and re-secured into opening 370, and other sections removed, to accommodate different patient needs.
Between the upper surface of cloth pad 364, and the lower surface of the inner sole 366 is a suitable material 398, for removably securing the inner sole 366 to the upper surface of the cloth pad 364. Material 398 may be hook and loop type material, or pressure sensitive adhesive, as noted hereinabove. The inner sole 366 may be formed of three layers 302, 304 and 306, which may be of progressively different softness and resiliency, with the softest and most resilient layer being the layer 302 closest to the foot, with layers 304 and 306 being progressively less resilient and providing somewhat greater support.
Another alternative embodiment of the present invention includes an inner sole having a plurality of independently vertically movable sections arranged in a grid pattern. Means are provided for independently and adjustably modifying the support of the foot at each section location. Referring to
It should be noted that the various embodiments of the present invention provide means to reduce shear forces on the sole of the foot. The grid pattern of resilient sections creates a multiplicity of sections that sway laterally independently of one another in response to forces applied by the foot. Typical soles simply resist lateral foot motion, thereby including shear stresses on the bottom of the foot which may cause or aggravate ulcers. Thus, in contrast to typical soles, the grid pattern of independently mobile resilient sections of the present invention constitutes means for reducing shear stresses on the bottom of a foot as the user walks along.
It should also be noted that inner sole assembly 52 may be worn interchangeably with either the right or left foot. So, for instance, a user may use the inner sole assembly to pad the left foot for a time, then later use it to pad the right foot. Likewise, the entire walker 12 may be designed to be worn interchangeably on either the right or left leg.
Concerning the dimensions of the removable sections, one operative and presently preferred embodiment of the invention employs hexagonal removable elements of the type shown in
In conclusion, a number of illustrative embodiments of the invention have been discussed hereinabove. However, it is to be understood that various changes and modifications may be made without departing from the spirit and scope of the invention. Thus, by way of example and not of limitation, the air bladder under the sole may be embedded in the soft goods member or may be located under it, between the soft goods support member 20 and the outer sole assembly 14. In addition, the optional bladder may be filled with a variety of fluids other than air, such as gel or water. The invention is, of course, applicable to other types of footgear, in addition to walkers, for example, athletic shoes or normal walking shoes. Accordingly, the present invention is not limited to the precise embodiments described hereinabove.
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|U.S. Classification||36/88, 36/110, 36/95, 36/93|
|International Classification||A43B13/40, A43B7/14, A43B13/38, A43B17/03, A43B17/02, A61F5/37, A43B7/20, A61F5/01, A61F5/00|
|Cooperative Classification||A43B17/026, A43B7/20, A61F5/012, A43B7/1465, A61F5/0111, A43B1/0009, A43B13/40, A43B17/02, A43B17/035|
|European Classification||A43B7/14A30R, A43B1/00A, A61F5/01D1D, A61F5/01D2, A43B7/20, A43B17/03P, A43B17/02, A43B17/02G, A43B13/40|
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Owner name: KAUPTHING BANK HF, NEW YORK
Free format text: SECURITY AGREEMENT;ASSIGNOR:ROYCE MEDICAL COMPANY;REEL/FRAME:016610/0376
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Owner name: OSSUR HF, ICELAND
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