A method of treatment of complications after joint replacement hydrogels

 

(57) Abstract:

The invention relates to medicine, in particular to plastic surgery. The method allows to reduce the treatment time, to prevent the formation of scar tissue and reduce the number of complications after joint replacement hydrogels. Removing the hydrogel from the inflamed area retromammary space, spend antibacterial therapy and put bandages and tampons with anti-inflammatory, thus immediately after removal of the gel from an inflamed area retromammary space cavity washed with chlorhexidine, then before applying bandages and tampons with an anti-inflammatory agent is injected into the cavity for 6-12 h the drug, which is a mixture of oil extracts of fruits of sea-buckthorn, calendula flowers, herbs, Hypericum perforatum and alcohol tincture of Sophora japonica, taken in the ratio of oil extracts of sea buckthorn 50 ml oil extracts of calendula 25 ml, oil extracts of Hypericum 25 ml of tincture of Sophora japonica 12-15 drops. In addition, if necessary, at the inflamed site impose the outer bandage with the drug under item 1, and oil extracts of sea-buckthorn berries, flowers of marigolds is parathas under item 1 is used as in the form of external bandages, and in the form of tampons or intracavitary injection within 3-4 days. 3 C.p. f-crystals.

The invention relates to medicine, namely to plastic surgery, and will find wide application in the treatment of inflammatory soft tissue complications after joint replacement hydrogels.

Contour soft tissue in plastic and aesthetic surgery using injectable gels has gained wide spread due to the simplicity and minimal trauma.

Currently in the Russian medical market there are several officially sanctioned by the Russian Ministry of health polyacrylamide gel: “Interval” (Ukraine), “Formacel”, “Aliform and Cosmogel” (Russia).

Adopted the term “polyacrylamide gel is a generalization of the trivial name of swollen polymers based on acrylamide (CH2=CH-C(O)-NH2). Production, properties and application of technical polyacrylamide is well known and described in the scientific literature [Sadovska M. N., Kholodova Y., Polyacrylamide. - Kiev. 1969].

Unlike other injectable materials medical polyacrylamides contain 95-97% water and only 3-5% of the polymer. Therefore, when the introduction of conjection synthetic materials.

All officially registered today medical polymers based on acrylamide, like all other polymers for medical purposes, passed sanitary-chemical, Toxicological and clinical trials in accordance with the approved Russian and international practices ISSO and showed a complete non-toxicity and harmlessness [Lopatin centuries Polyacrylamide materials for arthroplasty and their place in the range of polymeric materials for medical purposes //Annals of plastic, reconstructive and aesthetic surgery. - 2000 - N3 - S. 57-60].

Like all the currently known medical synthetic materials, polyacrylamide has its advantages and disadvantages. Advantages: ease of administration, intactness, weak tissue reaction, aquapilot, which allows the body to communicate with the implant tissue fluid and not to tear it. The drawbacks include the fact that these materials are a good breeding ground for various bacteria, which causes severe inflammation, which see doctors. The main drawback of gels, introduced by injection, the inability to evacuate them in case of suppuration. Teare depends on the compliance of asepsis during manipulation.

It is proved that the gel is inert for microorganisms, in addition to fungal saprophytes, but on the border of the gel and fabric is quite possible the development of microflora. The patient may be many conditions for endogenous infection: chronic tonsillitis, carious or periodontitis teeth, chronic adnexitis or prostatitis and so on

In various publications indicate possible negative consequences to the implantation of the gel [Nerobeev A. I. Osipov, I., Malakhovsky Century. And., Ishchenko A. L. experience in the use of polyacrylamide gel for soft tissue contouring // Annals of plastic, reconstructive and aesthetic surgery - 1997. - 2. S. 22-29].

Histological examination of the material often get conclusions about chronic inflammatory reaction at the site of implantation of the gel with the development of granulation tissue and fibrous scar process, summana foci gel. I.e., despite the absence of signs of inflammation, in fact it can be shown subclinical level. The most severe for the treatment group are patients with developed purulent inflammation, which always goes in the chronic phase. The clinical picture is typical sections giperpolyarizatsionnogo hydrogel for the correction of soft tissue of the lower extremities //Annals of plastic, reconstructive and aesthetic surgery - 2000. - 3. S. 61-66].

The morphological examination content wounds often get a picture of purulent inflammation with the formation of micro - and microabscesses. Destruction of the connective tissue associated with suppurative inflammation and possibly toxic effect by destroying the gel. Treatment of patients with complications after increasing soft tissue injection introduction of synthetic hydrogels is only possible through surgery and is a difficult problem [A. E. Belousov et al., 1998].

Known methods of treatment of inflammatory diseases of the mammary glands not associated with arthroplasty. For example, patent RF №2101040 (1998), in accordance with which it is directly on the mammary gland cause the ointment tamoxifen and subjected to the action of low-frequency magnetic induction. According to the patent of Russian Federation №212864 (1998) on the skin of the mammary glands cause the ointment titatanium and carry out the action of the pulsed or alternating magnetic field. The method of treatment patent No. 2066168 (1996) based on a holistic effect on the body of the patient course of reflex-correcting therapy of the spine in combination with the courses of breathing and physical exercises, pbim the disadvantage of the above methods is their inability to apply for treatment poplitealny complications after hip replacement due to a number of reasons, the main of which is the need of partial or full removal of the gel and washing the resulting cavity inflammation aseptic solution.

The known method of complex treatment of patients with complications after contouring the chest with polyacrylamide hydrogel [Vissarionov, C. A., Karpov, E. I. and other Principles of complex treatment of patients with complications after contouring breast polyacrylamide gel. International Symposium surgeons and oncologists 2000. - S. 114-117]. The essence of the method lies in the fact that when there is inflammation in the mammary gland perform a complete removal of the gel from centers of accumulation through the skin incision length 0.4 cm Formed cavity is drained by a thin silicone tube for 2-3 days in an aqueous solution of chlorhexidine, and then evacuate the remnants of the gel. Treatment for 12-14 days.

Known methods of treatment of cows patients with serous, catarrhal mastitis by intracisternal introduction therapeutic drug immotile, to which is added antibiotics [Ponomarev, B. C. et al., 1991], and a method of treating mastitis in cows by intracisternal use of the drug “streptococci” [patent RF №2012342, 1994].

The disadvantage of this method is its complexity and duration, as well as the possibility of scarring, which significantly affects the results of the treatment.

There is a method of treatment of complications after joint replacement hydrogels in plastic surgery, when performed a needle biopsy to determine punctate content of hydroxyproline and glucosaminoglycans and when the ratio of the first and the second not more than 0.3 carry out puncture to remove the gel from the inflammation. If this ratio is more than 0.3, then perform aspirazione-Subtotal removal of the gel. In the first case, after the operation, conduct local compressive stresses on the affected area. In the second case, produce a total compressive stresses. Additionally spend antibacterial therapy [RF patent №2182466, 2002].

Also known is a method of treatment of purulent-inflammatory diseases of the joints, trophic ulcers and nonhealing wounds [patent No. 2165754, 2001] by applying the ointment on the affected area, holding and subsequent removal ointment, a mixture of beeswax, olive oil, pine tar and pork fat, when this ointment is applied in a thin layer on a thick cotton cloth, apply to affected area and stand on the affected area 8-24 hours, after which the ointment is removed and, if necessary, to the affected area causing a new batch of ointment.

The disadvantage of this method is the inability intracisternal and intracavitary use.

The prototype of the invention we have chosen a method of treatment of complications after joint replacement hydrogels, namely, that on the background of the General anti-inflammatory and desensitizing treatment needle moisture content heliom or gray, involved in the inflammatory process, with subsequent introduction into the cavity of antibiotics, after which the mammary gland impose a bandage with water-soluble ointment base (levomicol,provide treatment tampons [A. A. Adamyan et al. Polyacrylamide mammary syndrome: clinical features, diagnosis, and treatment //Annals of plastic, reconstructive and aesthetic surgery, No. 4. 2001 S. 20-32].

The disadvantage of this method is the duration of treatment, failure to provide pain relief and the probability of formation of cicatricial changes, worsening cosmetic effect.

Similar treatment is applied and when the occurrence of inflammatory complications after joint replacement hydrogels leg and other soft tissues.

The objective of the invention is to develop a new effective method for the treatment of complications after joint replacement hydrogels, which helps to significantly reduce the duration of treatment, to prevent the formation of scar tissue and reduce the number of complications.

The problem is solved in that the treatment is carried out by removing the hydrogel from the inflamed area, after which the cavity is washed with chlorhexidine or other antiseptic solution and impose it on 6-12 h drug “Atlanta”, which is a mixture of oil extracts of fruits of sea-buckthorn, calendula flowers, herbs, Hypericum perforatum and alcohol tincture of Sophora japonica, taken in autosel tincture of Sophora, optionally filled plot impose the outer bandage or swab drug.

Oil extracts of fruits of sea-buckthorn, calendula flowers and flowers of St. John's wort is cooked in olive oil cold pressed extra class and drug Atlanta” is used in the form of external bandages, and in the form of tampons or intracavitary injection for 3-4 days.

The technical result obtained by use of the invention, is as follows: application of the proposed method of treatment significantly reduces the healing time, simple in design, easily tolerated, prevents the development of keloid scars.

Analysis of patent and scientific and medical literature did not reveal the described set of features that gives the basis to consider them with new, relevant inventive step.

In the result of years of research we have developed environmentally friendly treatment herbal remedies, called “Atlanta” not possessing allergic and toxigenic properties in relation to the organism as a whole and soft tissues in particular, destructive acting on pathogens inflammatory diseases without causing side is Anenii, to effectively treat inflammatory processes, including in hard-to-reach cavities of the body.

Thus, the complex combined application of components of plant origin, containing a large number of diverse active substances, collectively allowed us to obtain a therapeutic drug that has anti-inflammatory and antibacterial effect, put in the basis of its wide use in the treatment of many diseases.

When this drug “Atlanta” contains the components in such amounts that provide joint use most pronounced therapeutic effect, and used fat basis promotes effective release of the active components and rapid absorption.

Medicinal plants have long been used in folk medicine to treat various diseases. The advantage of medicinal plants is their low toxicity and the possibility of prolonged use without significant side effects. Therapeutic effect of medicinal plants currently used in medical practice, due to the presence of various biologically asset is Kim applicable physiologically active substances include glycosides, coumarins and furokumariny, essential oils, resins, tannins, vitamins. In addition to these active ingredients, therapeutic properties of medicinal plants are due to the presence of other types of chemical compounds such as organic acids, mucilages and gums, fatty oils, pintaldi, pigments, enzymes, mineral salts, trace elements and other

Such plants with strong medicinal properties include Sophora. It is known that the extracts of the fruits help with burns, diseases of the stomach and liver. It contains rutin, vitamin P, alkaloids: pahikarpin, sopocachi, N-oxide Copacabana, motrin, N-oxide matrina, pakarinen, sporamin, isoscopoletin, gebelin and organic acids (3,8-12%). Pahikarpin blocking N-holinoreaktivnye, so it is used in the treatment of ganglionitis and myopathy [Blinov, K. F. et al. Chemistry of the genus Sophora. //In the book: Proceedings Of Flax. Chem. Pharm. In-TA. 1967. vol. 21]. Tincture of Sophora japonica apply at purulent inflammatory processes.

St. John's wort contains 10-12% of tannins, heparin, hypericin, essential oils, flavonoids, azulene, saponins, vitamin C and carotenoids. Calendula - known medicinal plant that contains fluorodipalmitin funds. Substances extracted from Hypericum and calendula are regulators of vascular permeability and activators of regenerative processes.

Sea buckthorn is the richest source of tocopherol (vitamin E), having Mnogotochie biological action. Tocopherol possesses antioxidant properties, is involved in the formation of intercellular substance of connective tissue, smooth muscles of blood vessels. The composition of sea buckthorn contains vitamins P and s, And, F and group Century. Among other substances the fruits of sea-buckthorn berries contain a mixture of carotenoids, in particular-carotene, and polyunsaturated fatty acids: linoleic, linolenic, debilitating sclerotic processes in the body. Oil solution of sea buckthorn quickly heals trudnosgoraemye wounds, extensive burns, ulcers and other skin diseases. Along with your sea-buckthorn oil has analiziruem and analgesic action. Extracts of sea buckthorn and Sophora are inhibitors of microbial activity.

The inclusion in the composition of the mixture “Atlanta” that oil extracts of calendula and St. John's wort is primarily due to the presence of flavonoids, carotenoids and vitamins, which are well extracted and activated alivc the funds represented by playmonopolyonline (FMN) - this 5’-phosphate ester of Riboflavin or vitamin b2and flavine adenine dinucleotide (FAD). FMN is the precursor of FAD. These nucleotides are prosthetic groups for a certain class of redox enzymes - flavonegylcosides.

Another component of the medicinal herb mixtures are carotenoids, which are the “antioxidant vitamins”. The most known and widespread carotenoid is-carotene - the precursor of vitamin A. it is Known that the products of free-radical reactions, which occur when inflammation causes the disruption of biological membranes primarily due to the development of peroxidation of membrane lipids. The antioxidant activity of beta-carotene and other carotenoids due to their role in the inhibition of processes of lipid peroxidation and determines their biological functions. The basis of these features is somewhat independent of the physicochemical properties of these molecules. These features contribute to the ability of carotenoids to the regulation of growth and induction of cell differentiation. As immunomodulators carotenoids activate the synthesis of the T-dependent antibodies, interleukins. Their destiny increase in blood cells of natural killer cells and activated lymphocytes, the increase in the number of CD4 cells. Carotenoids increase their antiradical potential for joint action with other fat-soluble antioxidants, such as Tocopherols [ Captains A. B., A. Pimenov, M. the antioxidant Carotenoids as modulators of cellular metabolism. The success of mo. Biology. T 116. 1996, vol. 2].

This gave us reason to believe that flavonoids and carotenoids that are included in our mix, participate in a large number of biochemical processes that ensure the growth and development of cells of diverse tissues, including in the healing process.

Modern surgery has long justified the appropriateness of medical bandages and swabs from the differential impact on different stages of wound healing. For example, in the first phase of wound healing, when there is inflammation, swelling, redness, upset microcirculation, active infectious process proceeds, there is a large wound, the necessary bandages with products, providing intensive outflow of wound. These bandages must possess analgesic and, if necessary, necroticism and hemostatic effect.

In the second and third valuecity reinfection wounds, to absorb excess exudate, to prevent the formation of hypertrophic scars. These headbands are particularly well contribute to the growth of granulation tissue, but not epithelium. To avoid bezrucova wound healing, it is necessary to stimulate regional and islet epithelization. The healing of skin wounds, as well as reparative regeneration of other organs and blood vessels, is a cascade of cell-cell interactions, which starts from the output of the blood cells in the wound and inflammation. He continues with the formation of granulation tissue, reduction (contraction) and subsequent transformation in the rumen. All stages of this process are interrelated and interdependent.

General characteristic of the acute phase of inflammation - strong pain in the perifocal area, due to which the revision of the lesion under local anaesthesia is impossible. In any case, during remission, we found no damage to the muscles.

To improve quality, reduce terms of regeneration, to achieve anti-inflammatory, antimicrobial, desensitization effect, in addition to traditional therapies in the treatment of complications after joint replacement hydrogels, and when grass is Atlanta”.

Through its components “Atlanta” penetrates well into the skin and soft tissue, increases local metabolism, improves blood circulation in the soft tissues, lymph nodes, and stimulates the vital functions of the cells of the soft tissues, helps to eliminate foreign entity (bloody, purulent), stimulates the vital functions of cells, has anti-inflammatory, antibacterial and analgesic properties.

The detailed implementation of the method.

For preparation of the drug “Atlanta” use of plants in pharmaceutical packaging, i.e., collected and dried in accordance with the requirements for regulatory requirements - Standards for the collection and drying of plant material, without any special features. Alcohol tincture of Sophora japonica used drugs sold in pharmacies.

Take the dried raw material included in the collection, grind it separately to particles of appropriate sizes, sift. Herb Hypericum perforatum is a mixture of pieces of leaves, stems, flowers and unripe fruit size from 0.5 to 8 mm, the flowers of calendula consist of solid, partially crumbled baskets with a diameter of 5-8 see On 1 l of the and crushed fruits of sea buckthorn pour olive oil the top layer of oil was at the level of 3-5 cm above the surface of the fruit. All mixtures insist two weeks in a dark place, shaking daily. Hood hold olive oil cold pressed extra class, which take 10-100 times more than dry materials. The raw material is squeezed and filtered oil solution through a Buchner funnel, into which is put the filter material. The obtained oil extracts are mixed in a proportion of 50 ml oil extracts of sea buckthorn, 25 ml oil extracts of calendula, 25 ml oil extracts of St. John's wort, add 12-15 drops of alcohol tincture of Sophora japonica and placed in a tightly sealed flask of dark glass. We use olive oil “Extra” is a high-quality diet product obtained from the first cold pressing of selected svezhesorvannyh olives, which makes it “alive”. It contains no cholesterol, sodium, carbohydrates, and proteins, resulting in easily digested. These characteristics of such a framework allows to completely eliminate the negative influence on the quality of the extracted drugs. Receiving from Sophora extract the necessary components we offer therapeutic composition osushestvlyaetsya can be stored at T 6-10°C for 3-4 years. For the treatment of inflammatory complications after joint replacement hydrogels, the gel is removed from the inflamed area, the cavity washed with chlorhexidine or other antiseptic solution, after which it enter in 6-12 hours 10-50 ml “Atlanta”, which is a mixture of oil extracts of fruits of sea-buckthorn, calendula flowers, herbs, Hypericum perforatum and alcohol tincture of Sophora japonica, collected in 50 ml oil extracts of sea buckthorn, 25 ml oil extracts of calendula, 25 ml oil extracts of Hypericum and 12-15 drops of tincture of Sophora, optionally filled the area lay outside the dressing with the preparation for 8-24 hours This medication if necessary can also be used in the form of a tampon. The treatment course of 3-4 days.

Clinical example 1. B-Naya M, 27 years old, came with complaints to satisfy its volume of mammary glands. In April 1998, in the conditions of the operating room under local anesthesia according to the method, the Lukomski, through a needle of the author after the preliminary getroproperty retromammary space entered 160 ml of polyacrylamide gel Aliform both sides. The aesthetic result of the operation is good. Re-turned to the clinic to improve esteticheskoj is s, painless. At the request of the patient re-injection of polyacrylamide gel Aliform” in the amount of 40 ml with both sides. 1.5 months after the phase correction on the background of hypothermia, the patient developed pain in the lower-outer square of the left breast. Within days the pain was rapidly growing, appeared hyperemia, infiltration and tissue swelling of the left breast, body temperature quickly increased with a low grade (37,4-37,5°C) to 38.7°With General condition deteriorated bothered weakness, headaches, lack of appetite.

Examination: body temperature of 38.3°C; pale skin; breast - right: correctly rounded, upregulations consistency, the skin is a normal color, b/painful; left substantially increased in size, in the lower sections of the skin hypermonogenic, tense, local hyperthermia, significant tenderness to palpation.

When breast ultrasound:

Right: breast tissue is homogeneous, multiple condensed (thickness of 0.9-1.2 cm), lesions not detected; in the retromammary space lazerette entered polyacrylamide gel, the thickness of the retromammary PR is 1.8-2.0 cm, lesions in the breast tissue is not detected, the thickness of the retromammary space 4.5cm, megascale partitions over a large area in the projection of the lower lobe of breast cancer are not available, the contents of the resulting inflammation is “a single lake, presents a diffuse-modified gel.

Under local anesthesia lidocaine and 0.25% to 20.0 ml produced puncture retromammary space under pressure through the needle (d-2,0) obtained by 60.0 ml of purulent exudate with inclusions of the modified gel. Material punctate sent for histological examination. Histological examination revealed the presence of giant polynuclear cells, leukocytes, lymphocytes, plasma cells.

The cavity inflammation rinsed with chlorhexidine 0.1% to 1.5 l to obtain a clean wash liquid. Clean the cavity entered 10.0 ml of the drug “Atlanta”. Imposed aseptic locking compression bandage with the drug. Started anti-inflammatory and detoxification therapy. The next day, overall health has improved (T 37,4 With°), the pain disappeared. When bandaging received fewer inflammatory exudate (30,0-40,0 ml). In a similar way to the dressing and processing ponyme research.

After 6 months of outpatient follow-up surveys conducted correcting introduction of hydrogel (70,0 ml) in the retromammary space. Achieved positive cosmetic effect, satisfying the patient. Relapse was absent.

Clinical example 2. B-Naya F., 29 years old, came 4.02.2002, complaining of a slight pain in mammary glands, more in the left, which appeared after hypothermia. Pain occurred a month later, after the correction of the mammary glands using polyacrylamide gel on both sides with a good aesthetic effect. Objectively: the skin of the right breast of moderately hyperamylasemia, infiltration of tissues expressed moderately, local, T 37,3 With° (subfebrile temperature is observed within two weeks). The General condition is not suffering.

Treatment, consisting in carrying out detoxification therapy, and applying sterile dressings with drug Atlanta within 3 days.

The patient's examination 6.02.2002, had no Complaints. Elements catarrhal inflammation was completely absent. Temperature is normalized.

11.02.2002, When viewed from the patient phenomena of inflammation not obamedia in tissues was absent.

Under our supervision there were 45 patients with inflammatory complications after plastic surgery, which amounted to 3.3% of the total volume of transactions (1363). Their ages ranged from 21 to 50 years, and the main reason for seeking a surgeon was postpartum involution of the mammary glands (71.0 per cent), as well as defects of the lower extremities. In 28 women turgor breast tissue was reduced, the skin looked sluggish in the Central regions was observed folding. The lower limbs had insufficient muscle layer. In 64,3% (18 cases) complications after breast enlargement surgery was observed slow the inflammatory process. Therefore, to his relief, it was necessary the removal of the gel. It was produced at stage 1, as there had been mnogoplatnye clumps of gel, which were connected to each other in the form of communicating vessels, and after emptying one gel was slowly able to “spill over” into it from adjacent areas. This group of patients was conducted intracavitary administration of the drug “Atlanta” in the amount of 10-50 ml

33.7% (10) diagnosed catarrhal inflammation of the mammary glands. This group of patients the treatment of inflammatory complications was carried out by drug “Allie “Atlantaa” when inflammation complications in all cases led to a rapid full recovery and no recurrence.

Thus, the proposed method of treatment of complications after joint replacement hydrogels by using Atlanta” provides the following advantages over known:

- to prevent the development of total complications of the inflammatory process, requiring radical intervention

- reduce the time of treatment,

- to maintain the cosmetic effect,

to reduce the invasiveness of treatment,

- to contribute to the prevention of postoperative complications and scarring in the tissues, relapses,

- to carry out the re-prosthesis after 5-6 months after aspirazione-Subtotal intervention.

1. A method of treatment of complications after joint replacement hydrogels, including the removal of the hydrogel from the inflamed area retromammary space, antibiotic therapy and applying bandages and tampons with an anti-inflammatory agent, characterized in that immediately after removal of the gel from an inflamed area retromammary space cavity washed with chlorhexidine, then before applying bandages and swabs from protivovospalitelnoe calendula, herbs Hypericum perforatum and alcohol tincture of Sophora japonica, taken in the ratio of oil extracts of sea buckthorn 50 ml oil extracts of calendula 25 ml oil extracts of Hypericum 25 ml of tincture of Sophora japonica 12-15 drops.

2. The method according to p. 1, characterized in that the optionally filled plot impose the outer bandage with the drug under item 1.

3. The method according to p. 1, characterized in that the oil extracts of fruits of sea-buckthorn, calendula flowers and herbs Hypericum perforatum cooked in olive oil first cold pressed Extra-class.

4. The method according to p. 1, characterized in that the drug under item 1 is used as the outer bands, and in the form of tampons or intracavitary injection within 3-4 days.



 

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