RU2182808C2 - Shoes and method for manufacturing orthopedic shoes useable by diabetes mellitus patients suffering from diabetic pathologic foot changes - Google Patents

Abstract

FIELD: medical engineering; foot-wear engineering. SUBSTANCE: device has lining and upside layer, insertable insole and sole with fastening members and tongue. Additional inlay member is introduced into design which layers are not bound to each other. Upside layer and leather lining intermediate products are selected as integral and single-seam pieces. The insertable insole is multilayer member allowing to release pressure upon foot articulations in standing position. The insertable insole set is removable from the shoes to give additional space for comfortably positioning foot taking into consideration spatial parameter changes taking place in the course of the day. The tongue is attached to the external surface of shoe upside with sutures. Lining (leather lining) of shoes and insole layer engageable with foot are manufactured from plastezote material. Method involves modeling shoes, covering boot-tree and insertable multilayer insole and sublayer insole with polyethylene film. Next to it, leather lining is pulled over the boot-tree and the lining intermediate product is attached to the main soft insole and redundant material is cut off. Shoe is modeled by drawing upper border line and frontal quaters line over the lining, laying tape and gluing counter member to the lining. The so produced semifinished product The integral upside layer intermediate product is pulled over the so manufactured semifinished product. Shoe relief covered with decorative and strengthening cords is drawn and mark is laid. Semifinished shoe is uncovered along the lines of the front quaters and the shoe is taken off from the boot-tree after gluing sole. Then, soft collar is attached by suturing along the upper border and upper accessory members are sutured to the union member and the front quaters through the lining and shoe upside part. EFFECT: improved quality of shoes. 4 cl, 14 dwg, 1 tbl

Description

 The invention relates to medicine, namely to medical orthopedic shoes intended for patients with diabetes mellitus.

 Diabetes mellitus is one of the most common diseases at present. About 2% of the world's population suffer from this disease. It should be noted the annual upward trend in the number of patients with diabetes mellitus, mainly due to young and middle-aged people, and especially in developed countries. The Russian Federation is no exception in this regard.

 So, in the USA over the past 10 years, the number of patients has increased, on average, by 100 thousand people. In Germany in the years 60-79. the level of patients with diabetes reached 648 per 100 thousand people. In addition, in recent years, there has been an increase in diabetes patients among children and youths (in the USA among preschool children and schoolchildren, diabetes patients make up from 5 to 8% of the total number of patients with this disease), which is especially important not only for endocrinologists, but also for orthopedic surgeons. Most patients are aged 35-40 years (as you can see, this is the heyday of labor and life activity).

 Diabetes mellitus is a serious disease in which pathological changes occur not only in the internal organs, but also in the distal parts of the lower extremities: angiopathy (micro- and macro-), neuropathy, leading to the occurrence of neurotrophic disorders of one degree or another. It should be noted that in conditions of vascular insufficiency in diabetes, any, even minor damage to the skin of the foot, whether it be corns or abrasions, often leads to severe necrotic ulcers and even gangrene. Diabetic gangrene is a consequence of not only severe atherosclerosis of the arteries of the lower extremities, but also of diabetic microangiopathy. In connection with the latter, the sometimes observed development of dry gangrene sites with preserved pulsation of the corresponding arteries becomes clear.

 Arising pathological changes in the distal parts of the lower extremities and feet (or the existing prerequisites for their occurrence) in diabetes mellitus lead to a violation of the static-dynamic function of the feet, which leads to difficulties, and often the impossibility, of using ordinary shoes.

 Therefore, diabetes mellitus is a problem not only of endocrinologists, but also orthopedists, orthopedic prosthetists.

 The problem of orthopedic support for this category of patients is very relevant all over the world and, especially, in our country, where there are no analogues capable of replacing orthopedic shoes or special shoe inserts. However, despite the fact that in many countries of the world (USA, England, Germany, Italy) a certain range of orthopedic products on the foot for diabetes is proposed (special shoes, orthopedic insoles, special orthopedic elements, etc.), specialists from all over the world consider the problem of orthopedic support for this category of patients unresolved.

 In the textbook "Design and technology of orthopedic shoes" published by the St. Petersburg Research Institute of Prosthetics them. prof. G.A. Albrecht in 1996 gave an overview of the designs of orthopedic shoes and shoe orthopedic products, prescribed for various deformations and defects of the feet, and examined the main technological stages of the manufacture of orthopedic shoes based on medical indications. The design and method of manufacturing shoes for patients with diabetes mellitus are not indicated in the aforementioned training manual.

 One of the analogues of the designs of orthopedic shoes presented by us for patients with diabetes mellitus are the products of patent US 4463761, class. A 61 F 5/14, 1984. The closest analogues.

In the orthopedic industry, shoes are made, consisting of interconnected lining and upper, insole and sole, with fastening elements and tongue. However, these shoes do not adequately meet the requirements for shoes for patients with diabetes, namely, it must be provided:
- the exclusion of local and accentuated pressure of the upper shoe and interstitial layer on the soft tissues of the foot;
- the exclusion of hyperpression along the plantar surface of the foot due to the rational distribution of loads depending on the degree and stage of neuro-trophic disorders of the limbs;
- decrease in the strength of the shock moment when walking;
- uncomplicated rolling when walking;
- creating volume for a comfortable location of the foot, given the change in its parameters during the day;
- accounting of individual clinical and anatomical features.

 Thus, the design of orthopedic shoes for patients with diabetes mellitus presented by us fundamentally differs from that produced by the orthopedic industry in that it meets all these requirements.

 In the production of orthopedic shoes, a method of manufacturing it only with solid leather lining is used.

 The technological process of manufacturing orthopedic shoes (Table - “Route map of the manufacture of shoes with leather lining with a pronounced deformation.” “Orthopedic shoes are complex. Typical technological process 21312.01201.00001”), developed by the Leningrad Research Institute of Prosthetics in 1978, is that the lining is preformed on a wooden block, removed from the block, fitting heels are attached, it is tried on, and then modeling of the details of the top is carried out in the usual technological way (non-integral stock), final assembly of the blank with sewing on the tongue and fastener parts, top, attaching soles, stitching the top and lining (leather lining) along the upper and front edges.

 The proposed orthopedic shoes for patients with diabetes mellitus with the syndrome of "diabetic foot" consists of interconnected and made of whole-cut and single-seam upper and lining fastened with a seam with a soft main insole, an insole made of multilayer with the possibility of pressure exclusion in the standing position on the joints of the foot , soles, fasteners and tongue stitched on the outer surface of the shoe and a set of insoles-substrates, the layers of which are not bonded to each other. A set of insoles-substrates is made with the possibility of removing them from shoes to ensure a comfortable location when changing the volumetric parameters of the foot during the day, while the shoe lining and the insole layer in contact with the foot are made of plastesot (a material used in the prosthetic and orthopedic industry and manufactured from polyethylene foam LD weaving, produced in the form of strips of special density. It is characterized by elastic elastic properties - Expert opinion 10 / 01-136 from 06/07/1999 Scientific researcher Institute of Occupational Medicine of the Russian Academy of Medical Sciences).

 A method of manufacturing orthopedic shoes for diabetics with a diabetic foot pathology is that the lining and the upper of the shoe are modeled with whole cuts, cut, moisturize and sulk them, cut hard parts and bottom parts, assemble separately the lining and the top along the back seam, then they tighten the pad with a layered multilayer insole and insole with polyethylene film, then pull the lining onto the pad with insoles and grind the lining blank along the long edge with the base implicit soft insole, cut their surplus. After that, shoes are modeled by applying the lines of the upper edging and the front line of the berets to the lining, braid, glue the lining in the heel of the workpiece and back, gluing it to the lining, smoothing the trace with a cork layer and treating it along the running and side surfaces. Then a continuous inter-lining and close-fitting are glued in the heel of the shoe, the whole-finished workpiece of the upper is tightened on the semi-finished product and the shoe reliefs lined with decorative and reinforcing cords are circled, lay the trace. After gluing the soles, the shoe blanks are opened along the lines of the front berths and shoes are removed from the shoe, then a soft collar is attached along the upper hem, and the overhead parts of the shoe top are attached to the hem and berchiks through the lining and upper of the shoe.

 The invention is illustrated by drawings.

 Figure 1. Block (gypsum).

 Figure 2. Inserted insole.

 Figure 3. Insole-pad.

 Figure 4. Top fit.

 Figure 5. Lining - cut.

 6. The main insole is cut.

 7. Lining tightening.

 Fig. 8. Shoe modeling.

 Fig.9. Laying finishing and reinforcing braid.

 Figure 10. Adhesive back, trace alignment. cork layer.

 11. Gluing of the inter-lining and covering in the heel of the shoe.

 Fig. 12. Tightening the top of the shoe, outlining reliefs, gluing the soles.

 Fig.14. Ready-made shoes with a cut in the sock-beam part.

SUMMARY OF THE INVENTION
Orthopedic shoes (Fig. 14) consists of interconnected linings 1 and top 2, an insole 3 (Fig. 2) and a sole 4 with fasteners 5 and tongue 6. A set of an additional insole-substrate 7 is introduced into the shoes, the insole layers are substrates 7 are not bonded to each other. The insole-substrate 7 may contain 2-3 layers. The workpiece of the top 2 and the lining 1, fastened with a fillet seam with a soft main insole 8 (Fig.6), are made of whole-cut and single-seam, the insert insole 3 is made multilayer with the possibility of eliminating pressure in the standing position on the joints of the foot. A set of insoles-substrates 7 is made with the possibility of layer-by-layer removing them from shoes, providing additional volume for a comfortable location when changing the volumetric parameters of the foot during the day. The tongue 6 is attached to the outer surface of the upper 2 of the shoe, while the lining of the shoe 1 and the insole layer 3 in contact with the foot are made of plastesot (a material used in the prosthetic and orthopedic industry and made from polyethylene foam LD weaving, produced in the form of strips of special density It is characterized by elastic elastic properties - Expert opinion 10/01-136 of 06/07/1999 of the Research Institute of Occupational Medicine of the Russian Academy of Medical Sciences).

 A method of manufacturing orthopedic shoes includes modeling and cutting the lining, top and hard parts, assembling the lining and top, cutting the bottom parts, gluing the sole, stitching the top and lining on the upper and front edges, attaching accessories. The lining and the top are modeled with one-piece cuts (Figs. 4, 5), moisten and sulk them. After assembling separately the lining and the top at the rear seam, they tighten the shoe (Fig. 1) with a layered insole and insole-backing (Fig. 3) with a plastic film, tighten the lining on the shoe with insoles. Stitching the lining blank along the long edge with the main soft insole (Fig.7), cut off the excess. Shoes are modeled by applying the lines of the upper edging and the front line of the berets to the lining (Fig. 8), laying a braid (Fig. 9), glue the lining in the heel of the workpiece and adhesive, gluing it to the lining, leveling the trace with a cork layer, treating it with running and lateral surfaces (Fig. 10), a continuous interlining and tightening are glued in the heel of the shoe (Fig. 11), the whole-cut blank of the upper is tightened on the fabricated product, the shoe reliefs lined with decorative and reinforcing cords are circled (Fig. 12), the trace is laid , after gluing the soles, the shoe blanks are opened along the lines of the front berets (Fig. 13), the shoes are removed from the shoe, then a soft collar is attached along the upper hem, and the overhead parts of the shoe top to the vamp and berets through the lining and the upper of the shoe (Fig. 14) .

 The ratio of the length of the opening of the workpiece along the front berets to the circumference of the foot along the line of the beams is from 0.5: 0.74 units

 An assortment of shoes made in this way was approved by the medical and technical commission of the Federal State Institution “Glavortpomosch” under the Ministry of Labor and Social Development of the Russian Federation for the appointment of patients with diabetes with initial, severe and severe diabetic foot pathologies.

Claims (4)

 1. Orthopedic shoes for patients with diabetes mellitus, having diabetic foot pathology, consisting of interconnected and made of whole-cut and single-seam upper and lining, sealed with a thread seam with a soft main insole, an insole made of a multi-layer with the possibility of pressure elimination in the standing position on the joints feet, soles, fasteners stitched on the outer surface of the tongue shoe and a set of insoles-substrates, the layers of which are not bonded to each other, and a set of insoles-substrates is made removably from their shoes to provide comfort for the foot of volume when changing parameters during the day, the shoe lining and the insole layer, in contact with the foot, made of plastezota.  2. Shoes under item 1, characterized in that the insole-substrate contains 2-3 layers.  3. A method of manufacturing orthopedic shoes for patients with diabetes mellitus having a diabetic foot pathology, consisting in the fact that the lining and upper of the shoe are modeled with whole cuts, cut, moisturize and sulk them, cut hard parts and bottom parts, separately assemble the back and lining on the back a seam, after which they tighten the block with an insert multilayer insole and insole-substrate with plastic film, then tighten the lining on the block with insoles and grind the lining blank along the long edge with with the main soft insole, cut off their excess, and then model the shoes, applying the lines of the upper edging and the front line of the beers to the lining, lay the braid, glue the lining in the heel of the blank and the back, gluing it to the lining, level the track with a cork layer and process it with running and lateral surfaces, then a continuous interlining and tightness are glued in the heel of the shoe, the whole-cut workpiece of the upper is tightened on the resulting semi-finished product and the shoe reliefs lined with decorative and epitelnymi cords prostilayut track, and after bonding soles carried disclosure preform Shine berchikov front lines and pads to remove their shoes, then sew the upper collar soft edging, while the overhead parts to the shoe upper and the vamp berchikam through the lining and the shoe upper.  4. The method according to p. 3, characterized in that when opening the shoe blanks along the front berets, the ratio of the cut length to the circumference of the foot in the beam region is 0.5: 0.74.

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