EP1496764B1 - Shoe insole for diabetics - Google Patents

Abstract

A shoe insole ( 111 ) for diabetics is provided with a sole base body ( 136 ), a sole covering layer ( 137 ) and with a number of cushion-like layers ( 112, 113, 114, 115, 116 ) distributed over the surface of the sole. The cushion-like layers consist of at least one first cushion-like layer ( 112 ) in the forefoot joint area, a second cushion-like layer ( 113 ) in the midfoot/tarsus transition area, and of a third cushion-like layer ( 114 ) in the midfoot/heal transition area. These cushion-like layers serving to assist venous blood draining are each subdivided into individual plateau-like areas ( 118 to 127 ) that are adjacent in the transversal direction of the sole surface ( 117 ) while being separated from one another. The top side of the cushion-like layers also covered by the sole covering layer ( 137 ) is raised relative to the level of the top side of the sole base body ( 136 ). The aim of the invention is to provide a shoe insole of the aforementioned type that, while providing a lasting assistance of arterial inflow into the foot or foot sole area, has a continuing positive influence on the foot or foot sole areas endangered by a diabetic metabolic condition. To this end, at least one indentation ( 161, 162 ) is provided between the first cushion-like layer ( 112 ) in the forefoot joint area and the second cushion-like layer ( 113 ) in the midfoot/tarsus transition area. Said indentation serves to relieve the pressure on the midfoot bone capitulum(s) and emanates from the top side of the sole base body ( 136 ).

Description

The present invention relates to a shoe sole designed as a footbed according to the preamble of claim 1.

On average, every fifth in the age group between 20 and 70 years is in need of treatment for venous disease, and every third person has pathological vein changes that, although not requiring invasive treatment, still cause discomfort and require treatment. This generally results from an often hereditary connective tissue weakness, which leads to a relaxation of the venous walls and thus to a lack of ability to close the venous valves. This results in a reduction of venous return from the legs into the body. A shoe insole for such persons is from the EP 0 971 606 B1 known. Such shoe insoles provide by synergistic support of muscle contraction in the movement of the ankles and hocks a significant improvement in the venous return current at the foot starting through the legs in the body. The fact that the pillow-like layers are not solitary sublime but placed plateau-shaped in certain foot areas and divided into separate fields targeted areas, there are suitable abutment areas, which positively influences a contraction of the muscles in the foot. Due to these discrete abutment points, a homogeneous mechanical squeezing of the venous and lymphatic vasculature takes place during movement of the foot, but also to a good extent when standing, due to the stimulation and stimulation of muscle contraction the aforementioned increase in venous return from the legs leads bodyward. This characteristic support movement promotes the activity of the so-called foot and calf muscle pump. ( US 2001/039 746 A1 )

From the US-A-5 509 218 there is described a pillow-type device which is indicative of the repair of orthopedic problems due to stress on the foot while walking. For this purpose, Fußkontaktbereiche and moldings are described over the entire device in which additional pads are introduced. The indentations are described as increasing the contact areas to reduce the contact pressures, and the pads in these indentations have greater rigidity than the remainder of the pillow-type device to transfer the contact pressure to the footprint during the individual walking phases.

In addition, there are approximately 5 million diabetics in Germany, where a so-called "diabetic foot" can be more or less severe. This means: At the sole of the forefoot, open wounds that can become infected and that in rare cases lead to the necessity of a foot amputation (about 25,000 in Germany per year). The causes of the diabetic foot are that due to the diabetic metabolic condition in the arterial vascular system to narrow and possibly occlude larger arteries (macroangiopathy) and smaller arteries and capillaries (microangiopathy) comes. As a result, the tissue, in particular the skin, is no longer supplied with sufficient oxygen and is partially destroyed (open area). Due to the minor function, in particular the arterial capillaries, the skin nerves are no longer sufficiently nourished and there is diabetic polyneuropathy. This means that the affected person in the skin area, which is no longer sufficiently nourished, clearly loses the sensibility and thus the sensation of pain, so that anatomically prescribed pressure points are no longer registered and the skin is damaged "painlessly" and in this area an open skin area comes.

Object of the present invention is therefore to provide a shoe insole of the type mentioned, which is suitable for diabetics, ie, with continued support of the arterial inflow in the foot or sole area a more positive influence on endangered by the diabetic metabolic condition foot - or soles areas brings with it.

To solve this problem, the features specified in claim 1 are provided in a shoe insole of the type mentioned.

Even if the desired starting points for the support of the arterial inflow on the one hand and on the other hand endangered by the diabetic metabolic situation initially appear contrary, is achieved by the measures according to the invention that in a consistently improved arterial inflow those known endangered areas of the foot or the The sole of the foot can be relieved to such an extent that these vulnerable areas do not open up and, in addition, even so that vacancies recur over an acceptable period of time. In the first case, pressure points that lead to an opening of the specific places, do not arise, while in the second case by the pressure relief of the anatomically vulnerable sites they can go back, in both cases, the improvement of the arterial inflow and thus the blood flow in the capillary that is yours. This pressure relief results from the fact that due to the dents the metatarsal heads do not rest on the upper side of the sole surface but, so to speak, float freely. In this case, as mentioned, the discrete abutment areas for an improvement of the venous return flow are maintained, ie it comes to a relief of the peripheral veins and venous capillaries, which increases the arterial blood flow and thus means an improvement of the blood circulation and oxygenation of the tissue. The improved capillary arterial blood circulation leads to an improved supply of the sensitive nerves of the skin areas; the sensibility and thus the sensation of pain in the affected areas of the skin is improved, thus reducing the risk that these areas of the skin will open. All these components help the appearance of the diabetic foot too avoid and, if available, heal a diabetic foot without amputation.

With the features of claim 2 it is achieved that in particular the mainly anatomically endangered areas are relieved. Further embodiments result from the features according to claim 3 and / or 4. An advantageous arrangement of the indentations with respect to the pillow-like layers results from the features according to claim 5.

A particularly advantageous embodiment results from the features of claim 6 and / or in conjunction herewith from the features of claim 7 and 8, as a further support of the so-called floating state of the anatomically vulnerable sites and thus their further pressure relief is achieved.

To further promote blood circulation, the features of claim 9 and / or 10 are provided. The features of claim 11 may be appropriate.

With the features according to claim 12 it is achieved that the shoe insole is provided as a custom-made according to the anatomically vulnerable sites found in a patient, while the features according to claim 13 relate more to a series sole preparation.

Figur 1

eine Draufsicht auf eine Schuhinnensohle gemäß einem ersten Ausführungsbeispiel vorliegender Erfindung,

Figur 2

in vergrößerter Darstellung einen Schnitt längs der Linie II-II der Figur 2,

Figur 3

in vergrößerter Darstellung einen Schnitt längs der Linie III-III der Figur 1,

Figur 4

eine Draufsicht auf eine Schuhinnensohle gemäß einem zweiten Ausführungsbeispiel vorliegender Erfindung,

Figur 5

einen Schnitt längs der Linie V-V der Figur 4 und

Figur 6

eine Innenansicht gemäß Pfeil VI der Figur 4.

Further details of the invention will be apparent from the following description in which the invention with reference to the embodiments illustrated in the drawings and described in more detail. Show it:

FIG. 1

a top view of a shoe inner sole according to a first embodiment of the present invention,

FIG. 2

in an enlarged view a section along the line II-II of FIG. 2 .

FIG. 3

in an enlarged view a section along the line III-III of FIG. 1 .

FIG. 4

a plan view of a shoe inner sole according to a second embodiment of the present invention,

FIG. 5

a section along the line VV of FIG. 4 and

FIG. 6

an interior view according to arrow VI of FIG. 4 ,

The illustrated in the drawing and, for example, designed as a footbed shoe inner sole 11 and 111 according to two embodiments of the present invention serves in combination both the synergistic support of the muscles in the movement of the ankle and ankles to improve the arterial inflow in the foot and sole area and thus the circulation in the capillaries as well as the mechanical relief of problem areas on the soles of the feet due to (bad) diabetic metabolism. It can be designed as an insole or as a sole integrated in a shoe.

Like from the FIGS. 1 and 4 it can be seen, the insole has 11 or 111 more on the sole surface 17 and 117 provided pillow-like layers 12 to 16 and 112 to 116, of which the pillow-like layers 12, 112, 13, 113 and 14, 114 in separate individual , plateau-like fields 18 to 22, 118 to 122, and 23 to 25, 123 to 125 and 26, 27, 126, 127 are divided.

The first pillow-like layer 12, 112 is provided in the forefoot joint area, ie in the region of the toe.

This first cushion-like layer 12, 112 is subdivided into the five fields 18 to 22, 118 to 122, which are arranged next to each other and are arranged side by side in the transverse direction of the insole 11, 111. The individual fields 18 to 22, 118 to 122 are of different width and length, corresponding approximately to the base area of the partial areas of the respective individual toes. The same applies to the shape of the front and rear boundary line 28, 128 and 29, 129 of this first pillow-like layer 12, 112. The second pillow-like layer 13, 113 is in the transition region of the metatarsus and tarsal root and in a region which faces away from the arch of the foot , intended. This second pillow-like layer 13, 113 is divided into the three fields 23 to 25, 123 to 125, which are formed corresponding to this portion of metatarsus / tarsus and subdivided lying side by side in the transverse direction of the insole 11, 111. The same applies to the shape of the peripheral boundary line 31, 131 of this second pillow-like layer 13, 113. The third pillow-like layer 14, 114 is provided in a transition region of the metatarsus and heel and divided into the two panels 26, 126 and 27, 127, which in Transverse direction of the insole 11, 111 are seen side by side and are provided laterally outside. Again, the peripheral boundary line 32, 132 corresponds approximately to the transition region from the metatarsus to the heel.

The fourth pillow-like layer 15 or 115 is arranged in the region of the heel and is plateau-like as a unitary undivided, in the transverse or longitudinal direction of the insole 11, 111 formed approximately oval layer. Likewise, the fifth cushion-like layer 16, 116 is formed as a uniform non-divided layer, but approximately crescent-shaped provided in the region of the arch of the foot.

The pillow-like layers 12 to 16, 112 to 116 are made of an elastic (foam) material, for example a silicone produced. They have a flat upper surface and are approximately rectangular in cross-section, advantageously slightly trapezoidal.

Furthermore, between the first pillow-like layer 12, 112 in the forefoot region and the second pillow-like layer 13, 113 in the metatarsal / tarsal transition region, one or more indentations 61, 62, 161, 162 are provided for relieving the pressure on the head of the metatarsal , In the embodiments, the indentations 61, 62 and 161, 162 are arranged in the region of the second and third metatarsal heads; it is understood that these may instead be arranged in a different number and combination in the region of the first, second, third and / or fourth metatarsal heads.

In the first embodiment according to the FIGS. 1 to 3 the insole 11 has here a three-layer sole base body 36, which forms the basic shape of the insole 11 and according to FIG. 1 according to a foot, here the right foot is formed. It is understood that the corresponding other, ie left insole 11 is mirror-symmetrical. The sole base body 36 consists, for example, of three cork layers 33, 34, 35. On the sole base body 36, a sole cover layer 37 is provided which, for example, is made of leather. Between the sole base body 36 and the sole cover layer 37, the pillow-like layers 12 to 16 are embedded in the sole base body 36. For this purpose, the sole base body 36 is provided in its upper and middle layer 33, 34 with corresponding recesses 38, corresponding to the fields 18 to 27 of the pillow-like layers 12 to 14 and corresponding to the pillow-like layers 15, 16 have a different base area. The recesses 38 are incorporated into the sole base body 36 so deep that the flat top of the plateau-like pillow-like layers 12 to 15 each in approximately one plane, ie ccplanar with the surface of the sole base body 36 is located. An exception is the pillow-like layer 16. In this embodiment, the recesses 38 extend to the top of the lower layer 35. The pillow-like layers 12 to 15 each have approximately the same height and are in a range between 2 to 5 mm, preferably in one area at 3 mm. The upper material or the sole cover layer 37 covers the pillow-like layers 12 to 16 in such a way that these or their panels 18 to 27 are surrounded at the edge and firmly connected, preferably glued, to the middle layer 34 of the sole base body 36, so that apart from the boundary lines 28, 29 and 31, 32 approximately perpendicular to the transverse direction of the insole 11 extending intermediate boundary lines 41 to 47 result. In other words, the recesses 38 are formed corresponding to the total base area of the pillow-like layers 12 to 15.

In a manner not shown, it is possible, between the sole base body and the sole cover layer, a cushion-like elastic intermediate layer is provided over the entire surface of the sole body. The intermediate layer is made of the same elastic material as the pillow-like layers 12 to 16 and firmly connected to the entire surface of one of the depressions having layers of the sole body, preferably glued. The pillow-like intermediate layer may have an approximately uniform thickness over the entire base surface in the range of 2 to 3 mm, so that a solid flat cushion results, which is considerably more elastic than the layers of the sole body 36 and they can only between the lower layer and the middle layer be placed over the entire surface. The intermediate layer between the middle layer 34 and the upper layer 33 may instead have different thickness, so that the - The upper layer or recesses are provided with recesses corresponding to the depressions 38 for receiving the pillow-like layers 12 to 16, in turn, on the upper material or the sole cover layer in the same manner as the sole cover layer 37 after the FIGS. 2 and 3 extends.

The two indentations 61 and 62, which lie under the second and third metatarsal heads in use, start from the upper side of the sole cover layer 37. The depth of the indentations 61, 62 essentially corresponds approximately to the thickness of the two cork layers 33 and 34 or the intermediate layer, so that they extend to the bottom of the sole base body 36. The bottom of the indentations 61, 62 is formed by the sole cover layer 37. The two in the transverse direction of the shoe inner sole 11 adjacent recesses 61 and 62 are seen in the longitudinal direction of the shoe inner sole 11 in alignment with the field 19 and with the field 20 of the first pillow-like layer 12. Here are the two indentations 61 and 62 substantially approximately midway between the first pillow-like layer 12 and the second pillow-like layer 13.

In the second embodiment according to the FIGS. 4 to 6 the insole 111 has a two-layer sole base body 136, which forms the basic shape of the insole 111 and according to FIG. 4 according to a foot, here the left foot is formed. It goes without saying that the corresponding other, ie the right insole is formed mirror-symmetrical. The sole base body 136 is constructed from, for example, two cork layers or elastic plastic layers 133, 135, on which a sole cover layer 137, made of leather, is provided.

Between the sole base body 136 and the sole cover layer 137 are the pillow-like layers 112 to 115 in the Layer 133 of the sole body 136 is recessed manner. For this purpose, the sole base body 136 is provided with corresponding recesses 138, which have a different base area according to the fields 118 to 127 of the pillow-like layers 112 to 114 and corresponding to the pillow-like layer 115. For example, the sole body 136 has a maximum thickness in the range of 3.5 to 4 mm, preferably 3.7 mm and a minimum thickness in the region of its recesses 138 between about 1 mm and 1.5 mm, preferably of 1.3 mm. The example of multilayer sole sole body 136 may be coated over its entire surface of a fine textile overlay on its upper side. In a manner not shown, instead of or in addition, the underside of the sole body 136 may be coated over the entire surface with such a fine textile support. The sole base body 136 or its layers are produced from pressed with a binder cork scrap or from a plastic foam or natural latex.

According to FIG. 5 In addition, the upper side of the upper layer 133 of the sole base body 136 is also covered over its entire surface with a thin elastic intermediate layer 151, shown only as a thicker line. The intermediate layer 151 thus covers the entire surface, including the depressions 138 of the sole base body 136, so that recesses 152 corresponding to the depressions 138 are retained in the intermediate layer 151. The intermediate layer 151 has a continuous thickness of, for example, about 3 mm. The intermediate layer 151 is preferably like the pillow-like layers 112 to 116 of a foam, for example. Foamed natural latex.

In the recesses 152 of the intermediate layer 151, the pillow-like layers 112 to 115 are inserted, which are, for example, from said foamed natural latex and which, for example, have a thickness in the range between 4 and 5 mm, preferably 4.5 mm. In contrast, the pillow-like layer 116 is for the arch of the foot not in a depression but directly on the plane in this area, ie provided without recess intermediate layer 151. This pillow-like layer 116 is at its thickest point also about 4 to 5 mm, preferably 4.5 mm thick, wherein it decreases towards the inside of the sole 111 out steadily in thickness. The flat upper sides 156 of the plateau-like pillow-like layers 112 to 115 are thus raised by 1.5 to 2.5 mm, preferably by approximately 2 mm, from the upper side 157 of the intermediate layer 151. The upper material or the sole cover layer 137 covers the pillow-like layer 116 and also the pillow-like layers 112 to 115 such that the latter or their panels 118 to 127 are surrounded at the edge and firmly bonded to the intermediate layer 151, preferably glued, so that except the boundary lines 128, 129 and 131, 132 approximately perpendicular to the transverse direction of the insole 111 extending intermediate boundary lines or areas 141 to 147 result.

Furthermore, in the second pillow-like layer 113, the inner panel 123 is arcuately pulled over the outer panel 125 and the middle panel 124. This arcuate advanced portion 163 extends and widens the front surface of the field 123 FIG. 5 can be seen, this arcuate preferred region 163 is not flat as the other surface areas of the pillow-like layer 113, but curved upwards as a dome, ie raised against the raised top of the sole cover layer 137 again. This camber 163 raises the level of the field 123 in this area with respect to the fields 124 and 125 by about 2 mm and thus even further with respect to the indentations 161 and 162.

The dents 161 and 162 are also in this embodiment in longitudinal alignment with the second and third field 119 and 120 of the first In addition, they are located in a region between the first pillow-like layer 112 and the second pillow-like layer 113, substantially centrally between them. Furthermore, the position of the arcuate, ie arched, region is such that its tip 163 is approximately aligned with the transitional region from one indentation 161 to the other indentation 162 in the longitudinal extension of the shoe inner sole 111. In this way, due to the additional increase relative to the bottom of the indentation 161, 162, this arched region 163 of the field 123 causes a further increase in the pressure relief of the respective two metatarsal heads. Also in this embodiment, the bottom of the indentations 161, 162 near the bottom of the sole base body 136, wherein the circular base corresponds approximately to the anatomical surface design of the respective metatarsal head The base of the dome 163 may be larger than the pressure gauge of the indentation 161, 162. In one embodiment, not shown, adjacent discrete circular lobes, such as 61 and 62, 161 and 162, are combined into a single oval-in-plan view.

Claims (13)

1. A shoe insole (11, 111) for diabetics, having a sole base body (36, 136'), having a sole covering layer (37, 137), and having a plurality of cushion-like layers (12, 13, 14, 15, 16, 112, 113, 114, 115, 116), provided over the surface of the sole, in the form of at least one first cushion-like layer (12, 112) in the forefoot joint area, a second cushion-like layer (13, 113) in the midfoot/tarsus transition area, and a third cushion-like layer (14, 114) in the midfoot/heel transition area, these cushion-like layers, serving to assist the venous blood draining, are each individually divided into individual plateau-like areas (18 through 27, 118 through 127), located adjacent one another in the transversal direction of the sole surface (17, 117) and separated from one another, and the top side of the cushion-like layers, likewise covered by the sole covering layer (37, 137), forms an approximate plane with the top side of the sole base body (36) or is raised relative to the plane of the top of the sole base body (136), characterized in that between the first cushion-like layer (12, 112) in the forefoot joint area and the second cushion- like layer (13, 113) in the midfoot/tarsus transition area, discrete depressions (61, 62; 161, 162) are provided, serving to relieve the pressure on the heads of the corresponding metatarsal bones and originating at the top side of the sole base body (36, 136).
2. The shoe insole of claim 1, characterized in that one depression (61; 161) is provided for the second head of he metatarsal bone, and/or one depression (62, 162) is provided for the third head of the metatarsal bone.
3. The shoe insole of claim 1 or 2, characterized in that one depression is provided for the first head of the metatarsal bone.
4. The shoe insole of at least one of claims 1 through 3, characterized in that one depression is provided for the fourth head of the metatarsal bone.
5. The shoe insole of at least one of claims 2 through 4, characterized in that the depression (61, 62; 161, 162) for the respective head of the metatarsal bone is located approximately in alignment with the respectively associated plateau-like area (18 through 21, 118 through 121) of the first cushion-like layer (12, 112).
6. The shoe insole, in which the second cushion-like layer (113) is provided with an inner field area (123), drawn forward in a curve toward the first cushion-like layer (112) and arched so as to protrude relative to the raised top side of the sole covering layer (137) of the other areas or fields of the second cushion-like layer (113), of claim 1 or 2, characterized in that the drawn-forward inner field area (163) protruding in dome fashion, is in alignment with the portions adjoining one another of the two depressions (161, 162) for the second and third heads of the metatarsal bones.
7. The shoe insole of claim 6, characterized in that the diameter of the drawn-forward and protruding inner field area (163) is greater than the diameter of the depression (161, 162) for the second and for the third head of the metatarsal bone, respectively.
8. The shoe insole of claim 6 or 7, characterized in that the arching of the area (123) drawn forward in a curve raises the level by approximately 2 mm.
9. The shoe insole of at least one of the foregoing claims, characterized in that in the region of the heel, a fourth cushion-like layer (15, 115) is provided, which is plateau-like and preferably homogeneously oval in the transversal direction of the sole.
10. The shoe insole of at least one of the foregoing claims, characterized in that in the region of the plantar arch, a fifth cushion-like layer (16, 116) is provided of crescent-like shape.
11. The shoe insole of at least one of the foregoing claims, characterized in that the cushion-like layers (13 through 16; 113 through 116) are formed by a soft foam.
12. The shoe insole of at least one of claims 1 through 11, characterized in that it is embodied as a replaceable separately inserted insole.
13. The shoe insole of at least one of claims 1 through 11, characterized in that it is embodied as a sole that is integrated with a shoe.

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