RU2823180C1 - Method of treating patients with chronic lymphovenous insufficiency of lower extremities - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, medical rehabilitation, angiology, treatment of patients with chronic lymphovenous insufficiency (CLVI) of lower extremities and can be used in hospitals, sanatoriums, polyclinics, rehabilitation centres, as well as by the patient independently, in the presence of the corresponding pneumocompression apparatus (PCA) "Lymph-E-3". Each PCA procedure is preceded by lymphatic drainage self-massage with the patient lying on his/her back. Massage movements are circular surface planar strokes with planar shift only of skin relative to subcutaneous fat, in the sequence presented in the claim. At the end of the massage techniques, the patient in the supine position performs diaphragm breathing for 2 minutes. Further, the PCA procedure is carried out according to the scheme: 1) variable pneumocompression (VPC) using 7-section belt cuff on the abdomen, lumbar and inguinal regions in the ascending traveling wave mode: 10 min at pressure in all sections of cuff of 50 mm Hg and then 5 minutes at pressure in all sections of 60 mm Hg, with subsequent simultaneous deactivation of pressure in all sections of this cuff; 2) a proximal ascending VPC in the direction from the knee to the groin through the upper two sections of 7-section boot cuff with lower 4 sections switched off: 10 min at pressure of 50 mm Hg in isolated sections of the cuff above the thigh and further for 5 minutes at pressure of 60 mm Hg in the same insulated sections of the cuff, with subsequent simultaneous disconnection of pressure in them; 3) an ascending VPC of the lower extremities in the direction from the foot to the groin using all 7 sections of the boot cuff in the mode of an ascending wave with pressure memory for 30 min with the following ascending pressure gradient in seven sections of the cuff: in 1st section above the foot – 80 mm Hg, in 2nd section above the shin – 75 mm Hg, in 3rd and 4th – 70 mm Hg, in 5th and 6th above the hip – 65 mm Hg, in 7th section above the thigh – 60 mm Hg, followed by simultaneous pressure shutdown in all sections of the cuff. At the end of the VPC procedure, after the cuffs are removed, the patient in the supine position performs a series of repeated circular massage movements in a projection of inguinal and femoral lymph nodes according to the formula of the invention. Course includes 10 daily procedures, 5 days a week.

EFFECT: prolonged periods of remission with preservation of positive results achieved during treatment, prevention of disease progression and complications, due to inclusion of adaptive lymphatic drainage self-massage into procedures before VPC for preparation of proximal lymphatic collectors for inflow of lymph from periphery and due to more discrete mode of pressure supply to PCA cuffs; this makes it possible to act on the patient more softly and smoothly while maintaining positive therapeutic effects, to a greater extent imitating manual lymphatic drainage, as compared to the prototype.

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Description

The invention relates to medicine, medical rehabilitation, angiology, treatment of patients with chronic lymphovenous insufficiency of the lower extremities and can be used in hospitals, sanatoriums, clinics, rehabilitation centers, as well as by the patient independently, if there is an appropriate device for pneumocompression.

Chronic lymphovenous insufficiency of the lower extremities (CLVI) is the most common combined form of lymphatic edema of the lower extremities, in which lymphedema develops against the background of chronic venous insufficiency (CVI), or CVI complicates the course of classical lymphedema [B.B.Lee, 2020 Lee BB. Phlebolymphedema: Neglected Outcome of Combined Venous and Lymphatic Insufficiency // Vasc Specialist Int. - 2020. - Vol. 36. - N. 1. - P. 1-3.]. The progressive increase in morbidity, the high level of disability in patients predominantly of working age, as well as the significant economic costs of their treatment indicate the great medical and social significance of the problem of chronic pulmonary hypertension.

The development of CVI is caused by dysfunction of the unilateral valve system in the perforators and deep venous system of the lower extremities, which forms the reverse flow of venous blood into the superficial venous system. Valvular incompetence may be the result of age-related decrease in valve competence, latent or previous deep vein thrombosis (DVT), surgery, or other etiology [Fronek H.S., Bergan J. The Fundamentals of Phlebology: Venous Disease for Clinicians / American College of Phlebology, 2004] .

CLVN of the lower extremities is characterized by a progressive course and requires lifelong conservative treatment. Conservative methods of treatment and secondary prevention of symptoms of lymphovenous insufficiency (pain, heavy leg syndrome, cramps, lymphatic and venous edema, trophic disorders, fibrosclerosis, venous trophic ulcers) are widely used at different stages of the disease [Fundamentals of Clinical Phlebology / Ed. Yu.L. Shevchenko, Yu.M. Steadily. 2nd ed., rev. and additional - M.: ZAO "Shiko", 2013. - pp. 34-138, 308-334.].

However, among all patients with CLVN, about 10% of patients remain refractory to conservative therapy and require surgical treatment, and trophic ulcers develop in 15% of patients [Wittens C, Davies A.H., Bækgaard N., Broholm R., Cavezzi A., Chastanet S. et al. Management of Chronic Venous Disease. Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur. J.Vasc. Endovasc. Surg. 2015; 49(6): 678-737. Management of chronic venous disorders of the lower extremity. Guidelines according to scientific evidence. Int Angiol. 2014; 33(2): 173-175]. A first-time venous ulcer does not epithelialize in 50%, 20% and 8% of cases after 4 months, 2 and 5 years of conservative treatment, respectively. Moreover, 25% of healed ulcers recur within a year [Russian clinical guidelines for the diagnosis and treatment of chronic venous diseases. // Phlebology. - 2022.- T. 16. - No. 1. - P. 41-108. Rabe E et al.; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012;31(2):105-15.]. In case of ineffectiveness of conservative methods, various methods of surgical and endovascular treatment are used.

There are known surgical methods of treatment for CPVN of the lower extremities, aimed at correcting venous hemodynamics (elimination of venous hypertension, perforating discharges, proximal venous obstruction). Endovasal techniques are used (endovenous laser or radiofrequency obliteration, microfoam sclerotherapy, iliac vein stenting) [Management of chronic venous disorders of the lower extremity. Guidelines according to scientific evidence. Int Angiol. 2014; 33(2): 173-175. Gloviczki P., Cho J.S. Surgical treatment of chronic deep venous obstruction, In: Rutherford R.B., ed. Vascular Surgery. 5th ed. New York: Elsevier; 2001. P. 2099-2165. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555. PMID: 21725957]. The goal of surgical treatment for CVI is to reduce clinical symptoms, prevent the progression of CVI and normalize venous outflow.

There is a known method of treating patients with CLVN of the lower extremities by prescribing medications. The use of Micronized Purified Flavonoid Fraction (MOFF at a dose of 1000 mg per day) for chronic vascular insufficiency of the lower extremities has a lymphatic drainage, anti-inflammatory effect by increasing the contractile activity of lymphatic vessels, increasing the tone of the veins and reducing leukocyte aggression to the vascular endothelium [Perrin M., Ramelet A.A. Pharmacological treatment of primary chronic venous disease: Rationale, Results and Unanswered Questions. // European Journal of Vascular and Endovascular Surgery. Vol.41, 2011, p.117-125].

The principle of using venoactive drugs is to improve venous tone and capillary permeability, although the exact mechanism of action of most of these drugs is unknown. Flavonoids appear to influence leukocytes and endothelium, changing the degree of inflammation and reducing swelling [R.T. Eberhardt, J.D. Raffetto. Chronic venous insufficiency. Circulation, 111 (2005), pp. 2398-2409].

The disadvantages of drug treatment for CVI of the lower extremities are the duration of the course of treatment (reaching a therapeutic plateau of the drug after 2 months of treatment), which is 6 months or more, high cost, rare cases of intolerance and side effects [Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079. PMID: 21536172].

A Cochrane review of 44 RCTs found an effect of MOFF on edema and restless legs syndrome. Calcium dobesilate has been found to reduce leg cramps and restlessness; diosmin and hesperidin promote the healing of trophic changes in the skin, reduce cramps and swelling; rutosides reduce venous edema. However, this meta-analysis concluded that the evidence to support the global use of venoactive drugs for the treatment of CVI is insufficient. [M.J. Martinez, X. Bonfill, R.M. Moreno, E. Vargas, D. Capella. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev (2005) CD003229].

There is a known method of treating CLVN of the lower extremities by prescribing therapeutic exercises in the gym, including breathing exercises, exercises in the “lying on your back” position with movements in the large joints of each leg, movements in the joints of the toes, movements in the ankle joints, stroking the lower extremities from the foot to the thigh, exercises to strengthen the muscles of the lower extremities with alternating muscle tension and relaxation; movements of the ankles and lower legs in a standing position. Each exercise is repeated 10-15 times. The main goal of physical training is to increase the elasticity of the muscles and dermis in order to improve lymphatic and venous drainage. The dynamic work of the muscles of the venous pump of the foot and leg is an important factor in the regulation of venous outflow. Great importance is attached to the prevention of contracture and ankylosis of the ankle joint, the development of dorsal flexion of the foot, which improves the functioning of the joint pump, as well as breathing exercises [Padberg, FT, Johnston, MV, Sisto, SA. Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial. J Vasc Surg 2004; 39: 79-87. Cavalheri, G, de Godoy, JM, Belczak, CE. Correlation of haemodynamics and ankle mobility with clinical classes of clinical, aetiological, anatomical and pathological classification in venous disease. Phlebology 2008; 23: 120-124].

The disadvantages of using therapeutic exercises include the need for training on an ongoing basis and the presence of patient adherence to this method of treatment, the instability of its anti-edematous effect, the requirement to monitor the implementation of the complex by an instructor or exercise therapy doctor, since the clinical effectiveness of controlled physical exercises has been proven [Gürdal Karakelle S, Ipek Y, Tulin O, Alpagut İU. The effectiveness of exercise training in patients with venous insufficiency: A double blinded, randomized controlled trial. Phlebology. 2021 Jan 10:268355520985759. doi: 10.1177/0268355520985759. Epub ahead of print. PMID: 33423620].

There is a known method of conservative treatment for chronic pulmonary hypertension by prescribing compression therapy using multi-layer bandaging of the limbs with low-stretch bandages of short extensibility, creating increased pressure during physical activity (more than 60 mm Hg), stimulating the function of the muscle pump of the lower leg and the tolerated pressure at rest [Mosti G ., Mancini S., Bruni S., et al. MIRACLE Trial investigators. Adjustable compression wrap devices are cheaper and more effective than inelastic bandages for venous leg ulcer healing. A Multicentric Italian Randomized Clinical Experience // Phlebology. - 2020. - Vol. 35. - N. 2. - P. 124-133.]. This type of compression therapy is used in the first and second phases of Complex Decongestive Therapy (CBT/CDT) [Lee B.B. Phlebolymphedema: is it a new concept? // Phlebolymphology. - 2021. - Vol. 28. - N. 1. - P. 3-13].

CBT/CDT is an expensive and time-consuming method that requires significant physical and mental effort on the part of both the doctor and the patient. The negative effects of CBT also include the irritating effect of a high degree of compression, exerted directly on the skin and subcutaneous tissue of the affected limb (trophic skin disorders in the form of increased dryness, peeling, itching in the area of natural folds - popliteal fossa, arch of the foot, - atopic contact dermatitis, caused by long-term (for 23 hours a day) exposure to high pressure (69 mm Hg and above) created by a multilayer bandage of short-stretch bandages [Cravo M., Goncalo M., Figueiredo A. Allergic contact dermatitis to rubber-containing bandages in patients with leg ulcers.//Contact dermatitis. 2008; 58(6), pp.371-372]. significantly reduces the quality of life of patients with lymphovenous insufficiency and their adherence to treatment (compliance) [Mosti G., Partsch H. Is low compression pressure able to improve venous pumping function in patients with venous insufficiency? // Phlebology, 2010; 25:145-150]. Absolute contraindications to banding are concomitant diseases (severe patency of the arteries of the limb, cellulite and recurrent erysipelas).

In the latest published international Consensus [Rabe E., Partsch H. et al, 2020 Rabe E., Partsch H., Morrison N., et al. Risks and contraindications of medical compression treatment - A critical review. An international consensus statement // Phlebology. - 2020. - Vol. 35. - N.7. - P. 447-460] also identified very rare but severe adverse events with the use of MNB, including damage to soft tissues and nerves caused by excessive tension of the skin under the bandage.

Areas on the lower extremities with smaller radii, bony or tendon prominences are subject to higher local pressure according to Laplace's law than flat areas consisting primarily of soft tissue. Higher local pressure can lead to pressure necrosis, tissue ischemia, or nerve damage and is a particular problem in aging or fibrotic skin.

There is a known method for the treatment of CLVN of the lower extremities, which consists in the use of variable pneumatic compression (APC) - intermittent compression of tissues sequentially in the direction from the periphery to the center, in which conditions are created for displacing stagnant lymph from the interstitial space and microvasculature into the lymphatic vessels, increasing lymph flow through the preserved lymphatic collectors in the central direction. PPC is one of the most commonly used treatments for chronic lymphedema [Allenby F. et all. The use of pneumatic compression in the swollen leg. Physiological society, 1973]. The primary mechanism of action of PPC is to increase interstitial pressure in tissues, which promotes the outflow of fluid from the interstitial space and reduces edema.

Modern cuffs of devices for PPC (Lymfa-E, etc.) consist of 7-9 chambers designed to provide intermittent compression in the direction of lymph flow, and, as a rule, have several operating modes. When treating CVI of the lower extremities, a pressure of 60-90 mmHg is used. Art., “rising wave with pressure memorization” mode, the duration of the PPC session is 40-60 minutes, the course is 10-20 sessions. The disadvantage of this method is that the lymphatic drainage effect of PPC, used as an independent method of treatment (without previous complex treatment), as a rule, does not persist in the long term (3-6 months), and after completion of the course of PPC, the edema recurs quite quickly. In addition, when using PPC, there is a risk of developing genital lymphedema and swelling of regional lymph nodes [Boris M., Weindorf S., Lasinski B.B. The risk of genital edema after external pump compression for lower limb lymphedema // Lymphology. - 1998. - Vol.31, - N.1. - P.15-20]. PPC is contraindicated in patients with erysipelas and lymphangitis, thrombophlebitis, heart failure, and venous thrombosis.

PPC devices have pneumatic cuffs connected to a pump that, when applied to a person's limbs, mimic the muscle pump effect that occurs naturally when muscles contract around peripheral lymphatic vessels. It is believed that PPC may empty the terminal lymph nodes, thereby promoting fluid drainage from the interstitium and possibly promoting fluid flow from the interstitium into the lymphatic system.

However, if larger collectors are not ready to accept lymph flowing from the periphery and are not “activated,” this can cause a number of the above-mentioned complications in the form of the formation of new edema. Meanwhile, even in the instructions for the PPC device there are no instructions about the need to prepare the appropriate lymphatic collectors of the patient’s body, which seems to be a significant drawback.

For PPC, multi-sectional cuffs (7-9 sections) are preferred, and the cycle time must be synchronized with the contraction of lymphangions for effective removal of lymph from the limb. The pressure applied by the PCP device typically ranges from 35 to 120 mmHg. It is recommended to combine PPC with compression stockings between sessions to prevent the gradual return of edema [Lutoshkina M.G. Physical factors in the rehabilitation of chronic venous insufficiency // Physiotherapy, balneology and rehabilitation, No. 2, 2014, pp. 40-47].

PPC can be performed using the Lymfa-E device (AKVITA, Russia). When exposed to the PPK device, the pumping effect on the limb is created by filling the cuffs divided into 7 sections with air, which are filled gradually from the bottom up and exert the pressure set by the device on the limb. The filling cycle time of each section is 2 seconds, which is synchronized with the slow nature of the lymph flow, as well as the frequency of contraction of the lymphangions of the lower extremities. The programmed level of pressure applied by the PPC device ranges from 60 to 80 mmHg, which is equivalent to a pressure of 120-160 mmHg directly applied to the patient’s skin [Lutoshkina M.G., 2014].

Manual lymphatic drainage (MLD) technique [Therapeutic exercises in the pool and variable pneumatic compression for lymphedema of the lower extremities. Tutorial. M. BIBLIO-GLOBUS. 2019. 19 p. Chapter 3] involves the use of light hand movements on the skin of the limb with a pressure on the tissue of the limb of about 4 mm Hg. Art. In fact, in this case, only the skin moves relative to the subcutaneous fatty tissue (planar surface stroking is carried out, usually using three fingers - index, middle and ring).

In studies using lymphatic imaging (lymphoscintigraphy, LSG, ICG - indocyanine green), it has been proven that MLD promotes the movement of high molecular weight proteins into the lumen of the lymphatic capillaries and at the same time stimulates the contraction of lymphatic vessels. As a result, the flow of lymph through the subcutaneous plexuses and collaterals of the lymphatic vessels of the affected limb increases.

The goal of MLD is to direct lymph flow from blocked lymphatic vessels to open lymphatic vessels using special massage techniques that create light tangential pressure on the tissue. At the same time, lymph flow increases due to the opening of the valves of the lymphatic capillaries with the tension of the anchor (fixing) filaments, which are attached to the endothelial cell (usually in the area of contact of the endothelial cell) and are woven into collagen fibers located parallel to the capillary in the connective tissue matrix. Some practitioners add complex decongestant therapy (CDT) and variable pneumatic compression (VPC) - the Leduc method - to MLD.

Taradaj et al. (2013) investigated the effect of turning on the PPC (Flowtron Hydroven) in a pressure mode of 120 mmHg. and 60 mm Hg. to standard CBT in 33 menopausal women with bilateral primary lymphedema of the lower extremities and CVI. After four weeks, the reduction in limb volume in the group receiving PPC at 60 mm Hg was similar to those receiving standard CBT (without PPC), but the decrease in the group receiving PPC at 120 mm Hg. compared to CBT (~45% vs ~19%, p = 0.01). The authors concluded that AUC at 120 mmHg. Art. significantly contributes to the reduction of venous and lymphatic edema in women during menopause, however, PPC at a pressure of 60 mm Hg. turns out to be ineffective [Taradaj J., Halski T., Ozon M., et al. Comparison of efficacy of the intermittent pneumatic compression with various pressures in reducing the primary lower extremity venous lymphedema of menopausal patients // Przeglad Menopauzalny. - 2013. - Vol.17. - N.6. - P. 472-477].

In a prospective study by Muluk et al. (2013) reported results using an advanced programmable device, the Flexitouch System IPC. After treatment, 88% of participants had decreased limb volume (mean decrease 8%, p < 0.0001); 35% experienced volume reduction >10%. Higher BMI and greater limb volume at baseline were strong predictors of volume reduction. There was a decrease in skin fibrosis and an improvement in activity and range of motion in the ankle in 77% of participants. After the study, 50% of participants reported high satisfaction with their ability to control lymphedema using PPC [Muluk S.C., Hirsch A.T., Taffe E.C. Pneumatic compression device treatment of lower extremity lymphedema reveals improved limb volume and patient-reported outcomes // Eur J Vasc Endovasc Surg. - 2013. - Vol. 46. - N. 4. - P. 480-487.]. These authors concluded that widespread use of PPC devices is associated with consistent reductions in limb volume, decreased pain, and improved limb function.

In the RCT reviewed by Feldman et al., 2012, a number of participants reported discomfort at a pressure of 60 mmHg, so the study authors recommended a pressure of 50 mmHg. However, the pressure is 120 mmHg. Art., on the contrary, was well tolerated in the RCT conducted by Taradaj et al., 2013, as noted above [Taradaj J., Halski T., Ozon M., et al. Comparison of efficacy of the intermittent pneumatic compression with various pressures in reducing the primary lower extremity venous lymphedema of menopausal patients // Przeglad Menopauzalny. - 2013. - Vol.17. - N.6. - P. 472-477].

In a study by Tzani I., 2018, the authors concluded that in patients with lymphedema of the lower extremities, PPC should be used as an addition to CBT, a component of CBT in phase 1, or in phase 2 as a supportive method [Tzani I., Tsichlaki M. , Zerva E., Papathanasiou G., Dimakakos E. Physiotherapeutic rehabilitation of lymphedema: State-of-the-art // Lymphology. - 2018. - Vol. 51. - N.1. - P. 1-12.].

Thus, PPC is effective in reducing swelling, increasing joint mobility, and relieving subjective symptoms. In this case, it is preferable to use a lower compression pressure (30-60 mm Hg), however, higher pressure is also well tolerated by patients and can be used. Advanced PPC devices (simulating MLD) can be used in addition to early or late phase CPT for lower extremity CVI.

PPC has a relatively low risk of complications but may increase lymphedema of the trunk or genitals. High blood pressure in PPC may cause peripheral lymphatic damage. Therefore, careful observation is necessary to avoid displacement of edema proximal to the limb (i.e., closer to the trunk) or to the genitals, as this can lead to the formation of a fibrosclerotic ring developing at the root of the limb, which will further impede lymphatic drainage. PPC is recommended as an acceptable home adjunct to CBT in low to moderate pressure ranges (30-60 mmHg), and for use in the maintenance phase of edema, after CBT, or in combination with CBT after an MLD session, but not in isolation. That is, it seems necessary to carry out certain preparation of more proximal lymphatic collectors to accept the outflow of lymph from the periphery.

When using PPC, the following effects have been proven: an increase in the maximum velocity of venous outflow in the popliteal vein after compression of the foot and leg, an increase in peak blood flow velocity (PBV) in the deep veins, an increase in arterial inflow in a sitting position at a pressure of 120 mm Hg, an increase in flow in the popliteal artery, increased distance traveled, increased arterial flow in LDF, improved skin blood flow, increased tissue oxygenation, increased expression of nitric oxide by endothelial cells, systemic vasodilation, increased fibrinolytic properties, inhibition of procoagulants, increased protein absorption, increased tissue oncotic pressure, decreased edema [ Schwahn-Schreiber C., Breu F.X., Rabe E., et al. S1-Leitlinie Intermittierende Pneumatische Kompression (IPK, AIK) [S1 guideline on intermittent pneumatic compression (IPC)] // Hautarzt. - 2018. - Vol. 69. - N.8. - P. 662-673. German.].

The closest analogue (prototype ) of the proposed method is the method described in the dissertation: Aphanova T.V. Personalized application of complex methods of medical rehabilitation in patients with chronic lymphatic edema of the lower extremities. Diss...doctor of medical sciences, 2022, p. 104). This publication describes the implementation of improved hardware pneumocompression with pressure gradient regulation (UAP with RGD) from the Lymfa-E-3 apparatus (Akvita, Russia) for 60 minutes in case of chronic pulmonary hypertension of the lower extremities according to the following scheme:

- preliminary exposure was carried out using a cuff-belt on the abdominal, lumbar and groin areas in the “rising wave” mode 2, operating mode for 15 minutes at a pressure in the cuff of 50 mm Hg;

- then proximal ascending lymphatic drainage was carried out “from the knee to the groin” through cuffs-boots, operating mode 3, for 15 minutes at a pressure in the cuff of 60 mm Hg;

- during the main cycle, ascending hardware lymphatic drainage of all lower extremities “from the foot to the groin” was performed in the “ascending wave with pressure memory” mode for 30 minutes with an ascending pressure gradient from the foot (75 mm Hg) to the groin (60 mm Hg).

This method made it possible to simulate manual lymphatic drainage (MLD), since preliminary hardware lymphatic drainage using a cuff-belt and proximal thigh massage to prepare the proximal lymphatic system preceded drainage of lymph from the limb during the subsequent main cycle.

However, this technique was used as part of a large complex of other physiotherapeutic interventions (magnetic therapy, wraps, kinesio taping, therapeutic exercises in the pool, etc.).

At the same time, the technical task of the method we propose was to develop such a method of improved hardware pneumocompression (HAP), which the patient could use not only in a medical institution, but also independently (if there is an appropriate device), and ensuring the safety of use, the absence of complications, with prolongation of the remission period.

The technical result of the proposed method of treating patients with CLVN of the lower extremities of various origins is to increase therapeutic effectiveness in the form of lengthening periods of remission while maintaining the positive results achieved during the treatment process, preventing disease progression and complications during therapy using PPC, due to the inclusion of adaptive lymphatic drainage self-massage to prepare proximal lymph collectors for the flow of lymph from the periphery and due to a more discrete mode of supplying pressure to the cuffs of the pneumocompression device. This allows the patient to be treated more gently and smoothly while maintaining positive therapeutic effects, imitating manual lymphatic drainage to a greater extent, compared to the prototype.

The specified technical result is achieved by the fact that a method of treating patients with chronic pulmonary infarction of the lower extremities is proposed, including performing hardware pneumocompression with regulation of the pressure gradient in the cuffs using the Lymfa-E-3 apparatus.

Moreover, before each procedure of hardware pneumocompression, lymphatic drainage self-massage is performed with the patient lying on his back.

In this case, all massage movements are circular superficial planar stroking, during which only the skin moves in a plane relative to the subcutaneous tissue.

Massage movements begin with planar stroking of the opposite shoulder girdles with the palms, then, with the arms bent at the elbow joints, the hands are placed at the level of the shoulder joints of the same name and 5 active circular movements forward and 5 active circular movements backward are made in the shoulder joints.

Next, successive circular massage movements are carried out with 3 fingers of each hand in a rhythm of 1 second per 1 circular movement:

- 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck,

- then 10 circular massage movements in the area above the shoulder joints opposite the hands,

- then 10 circular massage movements in the projection of the posterior cervical lymph nodes behind the sternocleidomastoid muscle of the same name at the base of the neck,

- then sequentially 10 circular massage movements over the occipital region of the head, the projection of the behind-the-ear lymph nodes and the anterior ear lymph nodes,

- then repeat 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck,

- then, with the arms bent at the elbow joints, the hands are located at the level of the shoulder joints of the same name, repeat 5 active circular movements forward and 5 active circular movements backward in the shoulder joints;

after this, 10 circular massage movements are carried out in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of the skin shifting towards the femoral artery,

then - 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the femoral artery, with the direction of the skin shifting towards the femoral artery,

then - 10 circular massage movements in the area of the superficial femoral lymph nodes with the direction of skin shifting upward,

- then, in a supine position, the patient performs diaphragmatic breathing for 2 minutes, placing his palms on the anterior abdominal wall.

Next, the procedure of hardware pneumocompression is sequentially carried out according to the following scheme:

- variable pneumocompression (APC) using a 7-section “belt” cuff on the abdominal, lumbar and groin areas in the “rising traveling wave” mode: for 10 minutes at a pressure in all sections of the cuff of 50 mm Hg. and then for 5 minutes at a pressure in all sections of the cuff of 60 mm Hg, followed by simultaneous release of pressure in all sections of this cuff;

- proximal ascending ACC in the direction from the knee to the groin through the upper two sections of the 7-section “boot” cuff with the lower 4 sections turned off: for 10 minutes at a pressure of 50 mm Hg. in isolated sections of the cuff above the thigh and then for 5 minutes at a pressure of 60 mm Hg. in the same isolated sections of the cuff, followed by simultaneous release of pressure in them;

- ascending pneumocompression of the lower extremities in the direction from the foot to the groin using all 7 sections of the “boot” cuff in the “ascending wave with pressure memory” mode for 30 minutes with the following ascending pressure gradient in the seven sections of the cuff:

in the first section above the foot - 80 mm Hg,

in the second section above the shin - 75 mm Hg. Art.,

in the third and fourth sections - 70 mm Hg,

in the fifth and sixth sections above the thigh - 65 mm Hg,

in the seventh section above the thigh - 60 mm Hg, followed by simultaneous release of pressure in all sections of the cuff.

At the same time, at the end of the pneumocompression procedure after removing the cuffs, the patient, lying on his back, performs repeated 10 circular massage movements in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of planar shift of the skin towards the femoral artery, and 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the course of the femoral artery, with the direction of planar skin shift towards the femoral artery, and another 10 circular massage movements in the area of the superficial femoral lymph nodes with the direction of planar skin shift upward. The course includes 10 daily procedures, 5 days a week.

The proposed method with the additional use of lymphatic and lymphatic drainage self-massage techniques before and after the PPC procedure allows you to use several cycles for the limbs without the risk of developing rapid fatigue and overexertion, allowing you to better adapt and tolerate these procedures. Consistent compression for the abdomen, thighs and lower extremities potentiates the positive effect of each subsequent stage, which helps improve the lymphatic drainage function of the limb through active preparation and stimulation of lymph outflow through the thoracic lymphatic duct and outflow of venous blood through the vena cava system.

During pneumocompression of the abdominal and groin areas, the pressure in the abdominal cavity increases while the pressure in the chest decreases, the veins of which expand and suction occurs. The mentioned pressure changes ensure return transport of lymph through the lymphatic vessels in the direction from the periphery to the main lymphatic collector - the ductus thoracicus. That is why the preparation of not only the lower lymphatic collectors, but also the upper part of the body for the influx of lymph during the subsequent PPC seems to be significant for achieving the result of the proposed method.

Added to this is the “water jet pump effect”: improvement of venous transport through the system of the inferior vena cava, as well as stimulation of preserved lymph nodes.

Implementation of the method

The patient first performs a series of sequential self-massage techniques disclosed in the claims and aimed at activating the proximal lymphatic collectors, which helps reduce the risk of edema and damage to the proximal lymph nodes and vessels by increased lymph flow from the periphery during pneumocompression.

Then the patient is prescribed directly improved hardware pneumocompression with pressure gradient regulation (UAP RGD) from the Lymfa-E-3 device (Akvita, Russia) for 60 minutes according to the above scheme.

This complex method allows you to simulate MLD by combining a complex of lymphatic drainage self-massage and UAP RGD, since preliminary self-massage and hardware lymphatic drainage using a “belt” cuff and subsequent proximal thigh massage to prepare the proximal parts of the lymphatic system precedes the drainage of lymph from the peripheral parts during the subsequent the main cycle with an adjustable pressure gradient, the mode of which also promotes a smoother outflow of lymph to the proximal parts, which does not subsequently cause edema.

Example 1. Patient P.G., 55 years old. Diagnosis: CLVF of the lower extremities, stage III. Varicose veins of both lower extremities (C3). Secondary lymphedema of the left lower extremity associated with radical treatment of uterine cancer (T1N0M1) several years ago (hysterectomy with dissection of regional lymph nodes, followed by radiation therapy). Complaints of swelling of the left foot, lower leg and thigh, swelling of the right foot and lower leg, a feeling of fullness in the lower extremities, increased fatigue in the legs during static load, worsening in the evening. Five months after surgery and radiation therapy, lymphedema of the left lower extremity developed for the first time.

In the last 3 years, swelling and heaviness in the legs after static exercise have increased; there have been episodes of erysipelas (more than 4 per year), which required antibiotic therapy (4th generation cephalosporins, intramuscular).

When examined along the medial surface of the legs, mainly the left lower limb, there are varicose veins on both sides of the great saphenous veins (GSV) of the thigh. The swelling of the feet and legs is dense and painless on palpation; in the area of the feet and lower thirds of the legs, skin thickening is detected, with areas of fibrosclerosis. Positive Stemmer's sign on both sides (II-III degree). According to anthropometry, the difference in circumference in the lower 1/3 of the left and right shins, respectively, is +6.5 cm. Doppler ultrasound of the veins of the lower extremities on both sides revealed varicose veins of the GSV.

A deterioration in the overall quality of life (QOL) was revealed using the CIVIQ2 questionnaire - 67 points (with 20 points - complete health, with 100 points - the maximum decrease in quality of life). At the same time, the score on the pain scale was 15.0 points, on the physical scale - 17.0 points, on the social scale - 11.0 points, on the psychological scale - 24.0 points.

According to laser Doppler flowmetry (LDF), there was an increase in arteriolar tone, congestion in the capillary and venular parts of the microcirculation, a decrease in its efficiency index (IEM), a decrease in the level of capillary perfusion, signs of endothelial dysfunction (ED): a decrease in the amplitude of myogenic oscillations and endothelial oscillations on 34% and 42.3%, respectively; a decrease in the microcirculation index (MC) by 24.5% and an increase in shunt blood flow by 55.1%, as evidenced by an increase in the shunt index (PS) due to blood redistribution.

A complex course of treatment was carried out according to the proposed method - UAP with RGD with previous and subsequent methods of lymphatic drainage self-massage. The device “Lymfa-E-3” (AKVITA, Russia) was used according to the scheme disclosed in the formula of the proposed invention:

- before each procedure of hardware pneumocompression, lymphatic drainage self-massage is performed with the patient lying on his back,

- in this case, all massage movements are circular superficial planar stroking, in which only the skin moves in a plane relative to the subcutaneous tissue,

- begin the massage movements with planar stroking of the opposite shoulder girdles with the palms,

- then, with the arms bent at the elbow joints, place the hands at the level of the shoulder joints of the same name and make 5 active circular movements forward and 5 active circular movements backward in the shoulder joints,

- then carry out successive circular massage movements with 3 fingers of each hand in a rhythm of 1 second per 1 circular movement:

- 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck,

- then 10 circular massage movements in the area above the shoulder joints opposite the hands,

- then 10 circular massage movements in the projection of the posterior cervical lymph nodes behind the sternocleidomastoid muscle of the same name at the base of the neck,

- then sequentially 10 circular massage movements over the occipital region of the head, the projection of the behind-the-ear lymph nodes and the anterior ear lymph nodes,

- then repeat 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck,

- then, with the arms bent at the elbow joints, the hands are located at the level of the shoulder joints of the same name, repeat 5 active circular movements forward and 5 active circular movements backward in the shoulder joints;

- after this, 10 circular massage movements are carried out in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of the skin shifting towards the femoral artery,

then - 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the femoral artery, with the direction of the skin shifting towards the femoral artery,

then - 10 circular massage movements in the area of the superficial femoral lymph nodes with the direction of skin shifting upward,

- then, in a supine position, the patient performs diaphragmatic breathing for 2 minutes, placing his palms on the anterior abdominal wall;

then the procedure of hardware pneumocompression (HPC) is sequentially carried out according to the following scheme:

- variable pneumocompression of the PCP using a 7-section “belt” cuff on the abdominal, lumbar and groin areas in the “rising traveling wave” mode: for 10 minutes at a pressure in all sections of the cuff of 50 mm Hg. and then for 5 minutes at a pressure in all sections of the cuff of 60 mm Hg, followed by simultaneous release of pressure in all sections of this cuff;

- proximal ascending ACC in the direction from the knee to the groin through the upper two sections of the 7-section “boot” cuff with the lower 4 sections turned off: for 10 minutes at a pressure of 50 mm Hg. in isolated sections of the cuff above the thigh and then for 5 minutes at a pressure of 60 mm Hg. in the same isolated sections of the cuff, followed by simultaneous release of pressure in them;

- ascending pneumocompression of the lower extremities in the direction from the foot to the groin using all 7 sections of the “boot” cuff in the “ascending wave with pressure memory” mode for 30 minutes with the following ascending pressure gradient in the seven sections of the cuff:

in the first section above the foot - 80 mm Hg,

in the second section above the shin - 75 mm Hg. Art.,

in the third and fourth sections - 70 mm Hg,

in the fifth and sixth sections above the thigh - 65 mm Hg,

in the seventh section above the thigh - 60 mm Hg, followed by simultaneous release of pressure in all sections of the cuff,

at the same time, at the end of the pneumocompression procedure after removing the cuffs, the patient, lying on his back, performs repeated 10 circular massage movements in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of the plane shift of the skin towards the femoral artery,

and 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the femoral artery, with the direction of planar skin shift towards the femoral artery,

and 10 circular massage movements in the area of the superficial femoral lymph nodes with the direction of planar shift of the skin upward.

Course - 10 daily pneumocompression procedures with self-massage, 5 days a week.

At the end of the course of treatment, the patient’s condition improved noticeably: heaviness, painful distension in the lower extremities, and itching of the skin were practically not bothered. The malleolar volume on the left tibia decreased by 5.2%.

According to LDF data, microcirculation indicators improved: increased arteriolar tone (ALF/CKO x 100%) decreased by 18.2%. The indicator of the venular microcirculation (AHF/CKO x 100%) decreased by 22.4%. The contribution of endothelial oscillations to the overall level of fluxmotion increased from 7.8 to 11.9%, which indicates an increase in the secretory activity of the endothelium. This phenomenon was also accompanied by a significant increase in the amplitude of myogenic oscillations and a decrease in PN by 24.3% and 22.0%, respectively.

According to the results of the “CIVIQ2” survey, after a course of interventions there is a pronounced positive dynamics: on the pain scale - from 15.0 to 10.0; for physical education - from 17.0 to 11.0; for social - from 11.0 to 8.0; on the psychological scale - from 24.0 to 17.0 points. The overall quality of life indicator improved from 67 to 46 points.

In this patient, subsequently after 3, 6 and 9 months. There were no relapses of deterioration of the condition, although in previous years this was observed regularly 3-4 times a year. During control examinations, the achieved physiological indicators remain stable, which confirms the achievement of the above technical result.

Example 2. Patient D.A, 64 years old. Diagnosis: stage III CLVF of the lower extremities. Varicose veins in the GSV basin on the right, perforating insufficiency at the level of the lower thirds of the legs on both sides. Trophic disorders of the skin of the feet and legs. Psoriasis, cutaneous form, clinical remission.

Complaints of heaviness, distension in the legs and feet, worsening after static loads, constant swelling of the feet and legs to the level of their upper thirds, worsening in the second half of the day, after prolonged static loads, increased dryness and peeling of the skin of the hands and feet, hyperpigmentation. On objective examination, there is pronounced dense swelling of the feet and legs to the level of the upper thirds, D>S, and reticular varicose veins are observed in the thigh area. Positive Stemmer's sign on both sides (grade III). In the area of both legs, the skin is hyperpigmented, sclerotic, dry, with pronounced peeling (trophic disorders).

According to anthropometry, the difference in circumference at the level of the middle thirds of the right and left shins, respectively, is +3.0 cm. According to LDF data, a stagnant type of microcirculation, endothelial dysfunction, increased arteriolar tone, and reduced IEM are observed.

A course of influences was carried out according to the claimed method, according to the claims of the invention.

At the end of the course, significant improvements in the condition were observed: the heaviness and bloating in the legs practically disappeared, the phenomena of peeling and dry skin of the feet and legs decreased.

On objective examination, hyperpigmentation and induration in the lower leg area decreased. The malleolar volume on the right tibia decreased in the middle third by 6%, in the lower third - by 7.2%.

According to LDF data, congestive signs in venules and capillaries decreased by 22% and 33.4%, respectively, the initially reduced IEM increased to 90% and the rate of endothelial oscillations from 7.5 to 10.89%, as well as the amplitude of myogenic oscillations by 24% , with a reduction in PN by 22%.

There was a significant positive dynamics in quality of life indicators according to the results of “CIVIQ2”: on the pain scale - from 10.0 to 7.0; on the physical scale - from 18.0 to 10.0; on the social scale - from 19.0 to 11.0; on the psychological scale - from 27.0 to 17.0. The overall quality of life indicator improved from 74 to 45 points.

In this patient, subsequently after 3, 6 and 9 months. There were no relapses of deterioration of the condition, although in previous years they occurred up to 4 times a year, worsening in the spring-autumn period, as well as after colds and during exacerbation of background, concomitant diseases of this patient. During control examinations, the achieved physiological indicators remain stable, which confirms the achievement of the above technical result.

The proposed method was used in 22 patients aged from 40 to 72 years with CVI of the lower extremities, of which 14 were women, 8 were men, the average age was 56.2 years. The duration of the disease ranged from 2 to 32 years.

All patients clinically observed persistent, dense swelling of the feet, legs, and occasionally thighs. In 15 patients, against the background of lymphatic edema, trophic disorders of the skin of the legs and feet were noted in the form of increased dryness and peeling, hyperpigmentation, lipodermatosclerosis, and fibrosclerosis. Manifestations of venous dermatitis were observed in 12 patients. Almost half of the patients had concomitant diseases (hypertension, diabetes, osteoarthritis).

In the process of completing the proposed course with a complex of influences (self-massage and UAP with RGD according to the proposed scheme), microcirculation processes in the affected limbs improved in patients:

- increased arteriolar tone decreased (ALF/CKO × 100%): from 174.0±9.8 to 149.8±5.9 (p<0.05);

- congestion in the venules and capillaries has decreased, which leads to a decrease in venous pressure and increases the reabsorption of fluid in the venous section of the capillary, reduces ultrafiltration, and, consequently, lymph formation;

-the indicator of the venular microcirculation (AHF/CKO × 100%) decreased from 67.8±5.2 to 52.8±2.9 (p<0.05).

The consequence of improved microcirculation is improved tissue perfusion, reduced tissue hypoxia, improved trophism of the skin and subcutaneous fat.

The method also showed a significant improvement in the quality of life of patients with CVI of the lower extremities (the overall quality of life indicator improved by 35.9%).

There were no side effects or undesirable phenomena when implementing the proposed method; all patients tolerated the proposed procedures well, despite the fact that when implementing the prototype method, patients subsequently experienced isolated phenomena of the formation of edema at the root of the affected limb

As follows from the results of work carried out over a number of years, in comparison with the data obtained in the process of using a whole complex of methods according to the prototype method, the method we propose is not inferior to it in positive effects and supports long-term remissions in a number of clinical cases, even more than with treatment using the prototype method, while reducing the total number of physical impacts on patients, compared with the prototype, obviously due to a more physiological effect on the lymphatic system.

Thus, the proposed method of treatment for CVI of the lower extremities has high therapeutic efficacy, relieves clinical symptoms of the disease (severity, pain with distension in the affected limbs, swelling of the extremities, trophic and inflammatory skin disorders). The progression of the disease is prevented, the “quality of life” of patients is improved, and periods of remission are extended, including in the absence of taking venotonic drugs. The method can also be used for concomitant cardiovascular diseases, at any stage and duration of the disease.

Claims (29)

A method of treating patients with chronic lymphovenous insufficiency of the lower extremities, including performing hardware pneumocompression with regulation of the pressure gradient in the cuffs using the Lymfa-E-3 device, characterized in that, before each procedure of hardware pneumocompression, lymphatic drainage self-massage is performed with the patient lying on his back, in this case, all massage movements are circular superficial planar stroking, in which only the skin moves in a plane relative to the subcutaneous tissue, massage movements begin with planar stroking of the opposite shoulder girdles with the palms, then, with the arms bent at the elbow joints, place the hands at the level of the shoulder joints of the same name and make 5 active circular movements forward and 5 active circular movements backward in the shoulder joints, Next, successive circular massage movements are carried out with 3 fingers of each hand in a rhythm of 1 second per 1 circular movement: – 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck, – then 10 circular massage movements in the area above the shoulder joints opposite the hands, – then 10 circular massage movements in the projection of the posterior cervical lymph nodes behind the sternocleidomastoid muscle of the same name at the base of the neck, – then sequentially 10 circular massage movements over the occipital region of the head, the projection of the behind-the-ear lymph nodes and the anterior ear lymph nodes, – then repeat 10 circular massage movements in the area of the shoulder girdle opposite the hands at the base of the neck, – then, with the arms bent at the elbow joints, the hands are located at the level of the shoulder joints of the same name, repeat 5 active circular movements forward and 5 active circular movements backward in the shoulder joints; after this, 10 circular massage movements are carried out in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of the skin shifting towards the femoral artery, then - 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the femoral artery, with the direction of skin shift towards the femoral artery, then – 10 circular massage movements in the area of the superficial femoral lymph nodes with the skin moving upward, – then, in a supine position, the patient performs diaphragmatic breathing for 2 minutes, placing his palms on the anterior abdominal wall; Then the procedure of hardware pneumocompression is sequentially carried out according to the following scheme: – variable pneumocompression using a 7-section “belt” cuff on the abdomen, lumbar and groin areas in the “rising traveling wave” mode: for 10 minutes at a pressure in all sections of the cuff of 50 mm Hg. and then for 5 minutes at a pressure in all sections of the cuff of 60 mm Hg, followed by simultaneous release of pressure in all sections of this cuff; – proximal ascending variable pneumocompression in the direction from the knee to the groin through the upper two sections of the 7-section “boot” cuff with the lower 4 sections turned off: for 10 minutes at a pressure of 50 mm Hg. in isolated sections of the cuff above the thigh and then for 5 minutes at a pressure of 60 mm Hg. in the same isolated sections of the cuff, followed by simultaneous release of pressure in them; – ascending pneumocompression of the lower extremities in the direction from the foot to the groin using all 7 sections of the “boot” cuff in the “ascending wave with pressure memory” mode for 30 minutes with the following ascending pressure gradient in the seven sections of the cuff: in the first section above the foot – 80 mm Hg, in the second section above the shin - 75 mm Hg. Art., in the third and fourth sections – 70 mm Hg, in the fifth and sixth sections above the thigh – 65 mm Hg, in the seventh section above the thigh – 60 mm Hg, followed by simultaneous release of pressure in all sections of the cuff, at the same time, at the end of the pneumocompression procedure after removing the cuffs, the patient, lying on his back, performs repeated 10 circular massage movements in the projection of the inguinal lymph nodes located lateral to the femoral artery, with the direction of the plane shift of the skin towards the femoral artery, and 10 circular massage movements in the projection of the inguinal lymph nodes located medial to the femoral artery, with the direction of planar skin shift towards the femoral artery, and 10 circular massage movements in the area of the superficial femoral lymph nodes with the direction of planar shift of the skin upward, per course – 10 daily procedures, 5 days a week.