RU2593582C1 - Method of conservative treatment of trophic ulcers of soft tissues - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to surgery, and can be used for conservative treatment of patients with trophic ulcers of soft tissues. That is preceded by activation of autoplasma by centrifugation for 5 minutes with subsequent addition of 10 % calcium chloride solution in amount of 1:1. Then mixture is controlled for 20 minutes at temperature of 40 °C to obtain stabilised biologically active film. After treatment of ulcer and adjoining tissue with shock wave 100-1,000 strikes per cm², with impact strength 0.1 mJ/1 mm² and treatment of ulcer with sterile neutral solution produced film is applied on ulcer and covered with aseptic dressing. Procedure is repeated 7-8 times every 5 days.

EFFECT: method allows achieving healing trophic ulcers, reduced risk of extensive intermuscular hematomas, bleeding wound infections, thromboembolism, does not require hospital patients and anaesthesia care.

1 cl, 1 ex

Description

Critical lower limb ischemia (CINC) occurs in 500-1000 patients per million population per year (TASC II, 2007). In 42-67% of patients, ulcerative necrotic lesions of the distal extremities develop. Direct arterial reconstruction is not possible in 54% of patients due to the distal nature of the lesion. Conservative treatment is effective in only 25-49% in the presence of non-healing ulcers and in 50-70% for resting pain (Yu.A. Belkov, S.A. Kyshtymov, A.V. Dudnik, 2000; V.I. Gorenkov, 2006 ) Neoangiogenesis can conditionally be divided into surgical: lumbar sympathectomy, revascularizing osteotrepanation, laser, mechanical tunneling of the leg muscles, revascularizing osteomyoplasty, omentum transplantation on the feeding leg. And therapeutic: the introduction of autologous blood, the maintenance of gene constructs (VEGF, ANG, FGF genes), the introduction of Neovasculogen, the introduction of multipotent, mesenchymal stromal cells, the introduction of protein proangiogenic growth factors.

Analogue: revascularizing osteotrepanation (ROT) (Zusmanovich FN Thoracic and cardiovascular surgery. - 1994. - No. 5. - S. - 50-53).

For the treatment of trophic ulcers of the lower extremities, revascularizing osteotrepanation of the bones of the lower extremities is used, for which, depending on the level of occlusion of the main artery in the femur, tibia, bones of the pelvis and foot of the affected limb, 6-8 trepanation holes are formed, the diameter of which corresponds to 1/6 of the bone diameter . Trepanation holes penetrate only to the bone marrow. The approach to the bone is carried out mainly through acupuncture points.

The method is as follows.

1. The patient is placed on the operating table in a supine position. Under the lower leg of the operated limb, a roller is longitudinally laid. The skin of the lower limb is treated in one of the accepted ways.

2. Alternately at pre-marked biologically active points, the skin, subcutaneous tissue and aponeurosis are carefully pierced with a narrow-blade scalpel. If vessels and nerves are located in the projection of the target point, the skin is pierced nearby so that when holding a drill-trepan, the anatomically important formations are not damaged.

3. A hemostatic clamp is inserted into the wound and it is bluntly expanded. A protective tube-casing is put on the drill, it is inserted together with the tube into the wound and passed through the muscles to the bone. Having rested a drill in a bone strictly perpendicular to its long axis, first turn on the drill at low speeds; being drilled, they are enlarged. Every 10-15 seconds, the drill is stopped and drilling is resumed only after 1015 seconds. This is necessary so that the drill does not overheat and burn the bone. The last 2-3 mm compact plate is drilled at low speeds so as to catch the sensation of a drill failure in the medullary canal and possibly less injure the bone marrow.

4. After removing the drill, one suture is applied to the skin wound or left un sewn.

The disadvantages of the method are:

1. Injury, since when cutting the skin, subcutaneous tissue and aponeurosis with a scalpel, damage to the neurovascular bundles is possible.

2. High risk of developing infectious complications.

3. The possibility of fractures at the site of osteotrepanations.

4. Low efficiency with monotherapy.

5. A large number of contraindications to this operation.

6. Technical complexity, especially if osteotrepanation of the lumbar vertebrae and sacrum is performed.

7. High risk of thromboembolism.

The closest analogue: tunneling + PRP (Platelet - Rich Plasma) (patent RU 2 529 410 C1 IPC A6 B, 17/00, publ. 09/27/14)

For the treatment of trophic ulcers of the lower extremities, a combined method was proposed, including the use of autologous fractions and surgical tunneling of the leg muscles.

The method is as follows:

1. 2-4 hours before surgery, the patient is autosampled in the amount of 250-400 ml.

2. Autologous blood is centrifuged (EBA centrifuge) at 2300 rpm for 5 minutes (separation of red blood cells from plasma).

3. Then, the obtained blood plasma is additionally centrifuged at 4000 rpm for 5 minutes (activated platelets — Platelet — Rich Plasma (PRP) in the amount of 20-30 ml remain in the supernatant).

4. To activate the plasma before surgery add calcium chloride at the rate of 0.4-0.42 ml per 10 ml of contents).

5. Tunneling of the calf muscles circularly at 3-5 points using tube scalpels (TK-001, TK-002).

6. In the formed channels, activated plasma of 5-10 ml is introduced into each channel.

7. Sutures restore the integrity of the skin.

The disadvantages of the method

1. A large amount of autologous blood for therapy: 400 ml a single maximum allowable blood volume for a donor, according to existing legislation it is allowed to donate these blood volumes no more than 5 times a year for men and 4 times a year for women.

2. The use of special surgical instruments for tunneling (tube scalpels). Not all surgical hospitals have this capability.

3. The need for general anesthesia.

4. Postoperative risks: the risk of bleeding, the formation of extensive intermuscular hematomas, suppuration of the wound.

5. The need for daily dressings.

6. The need for inpatient treatment.

7. High risk of thromboembolism.

Tasks

- Improve the results of treatment of patients with trophic ulcers.

- The possibility of treating patients on an outpatient basis without the use of special anesthetics.

- To reduce the risks of postoperative complications of an infectious and non-infectious nature: bleeding, the formation of extensive intermuscular hematomas, suppuration of the wound.

- The possibility of self-care of the wound by the patient.

- Reduce the risk of thromboembolism.

Technical result

The advantage of this method of conservative treatment of trophic ulcers of soft tissues is that a biologically active film is applied to the ulcer previously treated with a shock wave. Therapy is aimed at accelerating and improving the quality of regenerative processes due to growth factors and cytokines, which are secreted from platelet α-granules. Most cytokines found in platelets contain TGF-β (producing growth factor β), PDGF (platelet-derived growth factor), insulin-like growth factors IGF-I and IGF-II, FGF (fibroblast growth factor), VEGF (vascular endothelial growth factor) , epidermal tissue growth factor and endothelial cell growth factor. Shock wave refers to acoustic waves. The shock wave used in medical technology is an extremely short, powerful pressure pulse with high pressure amplitudes and a small tensile component, which increases the production of critical wound growth factors, contributing to the appearance of capillaries. These techniques allow the healing of trophic ulcers, reduce the amount of autologous blood, reduce the risk of extensive intermuscular bruising, bleeding, suppuration of the wound, the development of thromboembolism, do not require hospitalization of patients, anesthesiology benefits, are used on an outpatient basis, reducing the total cost of treating a patient.

The essence of the invention lies in the fact that they stimulate repair processes in tissues by applying a biologically active film obtained from autoplasma by centrifugation for 5 minutes to an ulcer, add 10% calcium chloride to it at a rate of 1: 1, the mixture is thermostated for 20 minutes at at a temperature of 40 ° C, obtaining a stabilized biologically active film, and, after treating the wound surface zone with a shock wave in known modes and treating the ulcer defect with sterile neutral solutions, the film is applied to wounds harbor-hand surface and aseptic bandage, the procedure was repeated 7-8 times at intervals of 5 days.

A method for the conservative treatment of trophic soft tissue ulcers involves the use of shock wave therapy and a biologically active film.

The method is as follows.

1. Blood sampling is performed from the patient in the volume necessary for uniform coverage of ulcerative defects in test tubes (for example, “plasma lifting”).

2. Blood centrifugation is carried out in one of the following centrifuges: EBA 20 (Germany): 3200 rpm for 5 minutes; 80-2S (China): 3000 rpm for 5 min; "Plasmolifting" (Russia): 2500 rpm for 5 minutes

3. A biologically active film is prepared, for which a stabilizer - 10% CaCl _{2 is} added to the resulting plasma at a ratio of 1: 1 and kept in an thermostat at a temperature of 40 ° C for 20 minutes until a stabilized biological film is obtained.

4. Carry out a session udarnovolonovoy therapy using such apparatus Karl Storz PL 200, directly on the ulcer itself and adjacent soft tissue at a distance of 10 cm around ulcer, based 100-1000 strokes per 1 cm ² when the impact force the force of impact - 0 1 mJ / 1 mm ² ;

5. The ulcer is treated with sterile neutral solutions (0.9% NaCl), after which a biologically active film is applied.

6. Apply an aseptic dressing to the ulcer.

7. The procedure is carried out 1 time in 5 days, a course of 7-8 procedures.

This treatment method was tested in the conditions of the “In Safe Hands” medical center since 2012, 32 patients with various types of trophic ulcers were treated. In 26 patients (81.3%), complete healing of the ulcer was achieved, and in 6 patients the ulcer area was reduced by 70%.

Clinical example

Patient K., 53 years old, was admitted to the hospital with a diagnosis of diabetes mellitus, type 2, subcompensated course. Diabetic foot syndrome, neuroischemic form, trophic ulcer of the lateral ankle region. According to the patient, the ulcer exists for about 1.5 years. Slowly increased in size, conservative infusion therapy had no effect. Ultrasound diagnosis of vessels of the lower extremities - hemodynamically significant vascular pathology of large vessels was not detected. The patient underwent conservative therapy according to the proposed method: using shock wave therapy and applying a biological active film once every 5 days for 8 courses. After 40 days of treatment, complete healing of the ulcer was achieved.

Patient S., 67 years old, came to the clinic on 03/27/2014, during the examination he was diagnosed with atherosclerosis, chronic arterial insufficiency of 4 tbsp., Popliteal artery occlusion on the right, posterior and anterior tibial arteries on the right, trophic ulcer of the anterior lateral surface of the right lower leg. Ultrasound diagnosis of vessels of the lower extremities: occlusion of 80% of the femoral-popliteal segment on the right, occlusion of 90% of the anterior and posterior tibial arteries on the right. The patient underwent conservative therapy according to the proposed method: using shock wave therapy and applying a biological active film once every 5 days for 8 courses. After 40 days of treatment, complete healing of the ulcer was achieved.

Claims (1)

A method of conservative treatment of trophic ulcers of soft tissues, including stimulation of repair processes in tissues, characterized in that autoplasma is activated prior to centrifugation for 5 minutes, 10% calcium chloride solution is added to it at a rate of 1: 1, the mixture is thermostated for 20 min at a temperature of 40 ° C, obtaining a stabilized biologically active film, and after processing the ulcer and the adjacent tissue with a shock wave of 100-1000 strokes per cm ² , with a shock force of 0.1 mJ / 1 mm ² , and processing the ulcer st With a neutral solution, the resulting film is applied to the ulcer and covered with an aseptic dressing, the procedure is repeated 7-8 times with an interval of 5 days.