RU2610211C1 - Method of retrosclerofilling of eyes with dispersed biomaterial "alloplant" - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to ophthalmosurgery, and can be applied to increase efficiency of retrosclerofilling of eyes with dispersed biomaterial "Alloplant". For this purpose cut of conjunctiva, shifting of cut relative to underlying tennon membrane parallel to limb by 3-4 mm are performed. After that, cut of tennon membrane and introduction of dispersed biomaterial "Alloplant" in tennon space are realised, needle is extracted with the following spontaneous reposition of eye membrane and self-hermetisation of wound. Additionally pre- and postoperative period injection influence on biologically active points with biomaterial "Alloplant for acupuncture introduction", diluted in physiological solution in ratio: 30-50 mg of biomaterial per 0.3 ml of physiological solution, is performed. Injections are made in points VB1 (Tong zi liao), VB14 (Yang bai), V10 (Tian zhu), bilaterally, 0.5 ml in one injection, in sessions in quantity 1-10 s with 1-7 day periodicity.

EFFECT: invention makes it possible to increase clinical efficiency of eye retrosclerofilling, realised in case of their chronic diseases, associated with hemodynamic malfunctions in organism.

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Description

The invention relates to medicine, in particular to ophthalmic surgery, and can be used to increase the clinical effectiveness of retrosclerotherapy of the eye with dispersed Alloplant biomaterial.

Drug treatment of many chronic eye diseases dictates the need to choose the optimal method of drug administration based on its effectiveness and safety. The subtenon administration route of the drug is more preferable, allowing to increase the effectiveness of treatment with a decrease in the dose of the administered drugs and, accordingly, their side effects (Gilmanshin T.R., Altynbaev U.R., Akhtyamov K.N., Habsalikova R.T., Alekseeva L.P. “Advantages and disadvantages of local routes of administration in ophthalmology”, a collection of scientific papers of the scientific-practical conference on ophthalmic surgery with international participation “East-West”, May 13-14, 2011 GU “Ufa Scientific Research Institute of Eye Diseases” Academies Of Sciences of Belarus, under the. Ed. Prof. M. Bikbova, Ufa, 2011).

There is a method of introducing drugs into the tenon space, carried out by simultaneously dissecting the conjunctiva and tenon membrane with the introduction through a blunt needle curved in the shape of a vowel into the tenon space of the drug with subsequent suturing of the surgical wound. This method, also called retrosclerotomy (RSP), allows you to enter suspended forms of drugs (Remizov MS "Method for the surgical treatment of progressive myopia", Vestnik Ophthalmology, 1981. - No. 3. - S. 26-29). The disadvantage of this method is the need for a suture on the surgical wound, which causes discomfort, the formation of blepharospasm, hyperemia of the edges of the wound, long healing time.

There is a known operation of RSP, according to which a suspension of dispersed Alloplant biomaterial is introduced into the tenon space ("Do we correctly operate on glaucoma? To the question of the pathogenesis and treatment of glaucoma", under the general editorship of E.R. Muldashev, published by OSMA Media Group, 2013, pp. 108-109). The operation of the RSP can be used to treat a variety of ocular pathologies and allows you to stabilize visual functions for some time (Galimova V.U., Karimova Z.Kh. “Experience in the use of Alloplant biomaterial in the treatment of the effects of ischemic neuroopticopathy”, breast cancer “Clinical Ophthalmology” No. 1 dated January 26, 2012 p. 5; Bulatov RT “Sclerotherapy strengthening retroscleroplasty with dispersed Alloplant biomaterial in case of progressive myopia”, abstract of thesis ... Candidate of Medical Sciences - Ufa, 2000; Sultanov RZ “Operation of medical retroscleroplastic the use of dispersed Alloplant biomaterial in the treatment of diabetic retinopathy ", abstract of thesis ... candidate of medical sciences. - Krasnoyarsk, 2000; MP Kornilayeva," Operation of medical retroscleroplasty in primary glaucoma with normalized ophthalmotonus ", abstract of ... thesis. . - Chelyabinsk, 2007).

It is known to use the Alloplant biomaterial in ophthalmic surgery, which has the ability to stimulate regenerative processes with the ability to correct fibrotic and degenerative-dystrophic processes in tissues (RF patent No. 2189257, IPC A61L 27/00, A01N 1/00, published on September 20, 2002).

Closest to the proposed and taken as a prototype is the method of retrosclerotherapy (RF patent No. 2454208, IPC A61F 9/007, published on June 27, 2012). The method consists in introducing drugs into the tenon space of the eye. According to this method, the conjunctiva is sequentially dissected, its incision is shifted relative to the underlying tenon membrane parallel to the limb by 3-4 mm, the tenon membrane is dissected and a drug substance, for example, the dispersed Alloplant biomaterial, is introduced. Sutures are not overlapped, since after removing the needle, spontaneous reposition of the membranes of the eye and self-sealing of the surgical wound occur. This allows you to reduce the duration of the recovery period and the number of complications.

The disadvantage of the above methods is the limited clinical effect due to the exclusively local nature of the effects of drugs in retroscleroplasty of the eyes.

Meanwhile, the causes and nature of the course of many requiring surgical treatment of chronic eye diseases are determined by the leading role of hemodynamic disorders. So, for example, the main contingent of patients with ischemic eye lesions is elderly people with general vascular and systemic diseases, in which the leading pathogenetic link in visual impairment is impaired circulation of the optic nerve due to spasm, stenosis and obliteration of the supply vessels, followed by thrombosis or embolism. Retroscleroplasty surgery is also not effective for eye diseases that occur with lesions of the overlying structures of the visual system, such as descending atrophies of the optic nerve of various origins (trauma, intoxication, demyelinating diseases), damage to chiasm, optic tracts, including cerebrovascular pathologies that are accompanied by hemodis disorders in the visual system.

The technical result of the invention is to increase the clinical effectiveness of the operation of retrosclerotherapy with dispersed Alloplant biomaterial by means of additional correction of hemodynamic disorders.

The specified technical result is achieved by the method of retroscleroscopic eye filling with dispersed Alloplant biomaterial, including sequential dissection of the conjunctiva, offset of the incision relative to the underlying tenon shell parallel to the limb by 3-4 mm, after which the tenon shell is dissected and the dispersed Alloplant biomaterial is introduced into the tenon space, removed a needle followed by spontaneous reposition of the eye membrane and self-sealing of the wound, in which, unlike the prototype, in the pre- or postoperative period, they are injected onto biologically active points with Alloplant for Acupuncture Administration biomaterial diluted in physiological saline in the ratio: 30-50 mg of biomaterial per 3.0 ml of saline, and injections are performed at points VB1 (Tun Zi Liao), VB14 (Yang Bai), V10 (Tian Zhu), bilaterally, 0.5 ml in one injection, in sessions of 1-10 with a frequency of 1-7 days.

The specified technical result is achieved due to the following. A known method of exposure to the human body by injecting the introduction of dispersed Alloplant biomaterial through a system of biologically active points, aimed at restoring the underlying mechanisms of nervous regulation, metabolic processes, homeostasis (RF patent No. 2238076, IPC A61H 39/08, published on October 20, 2004 .).

The impact on the biologically active point V10 (Tian Zhu), in addition to the reflex improvement of cerebral blood flow, allows you to selectively increase blood flow and activate the cortex of the visual analyzer in the occipital lobes of the brain. Exposure to the points VВ1 (Tong tzu liao) and VВ14 (Yang Bai) allows one to selectively enhance local microcirculation at the level of the retina, ciliary body, and optic nerve. The proposed method combines the effect of surgical intervention - retroscleroplasty with the effects of targeted reflexogenic hemodynamic effects, which is not obvious for ophthalmic surgeons as well as for reflexologists. As a result of the integrated effect, a qualitatively new effect is achieved in improving oxygenation, enhancing metabolism and activating the processes of reparative regeneration in all tissues of both the central and peripheral parts of the visual system. Acupuncture according to the proposed method is safe, does not require separate specialization in reflexology, and is easily tolerated by patients. Stimulation of optimally selected points due to the synergy of their work provides the maximum effect in terms of normalization of hemodynamics. Thus, an additional injection effect on biologically active points with Alloplant biomaterial immediately before or after retroscleroplasty provides an increase in the efficiency of the operation.

The method of retrosclerotomy eye biomaterial "Alloplant" is as follows. Consecutive conjunctiva is dissected, the incision is shifted relative to the underlying tenon shell parallel to the limb by 3-4 mm, then the tenon shell is dissected and the dispersed Alloplant biomaterial is introduced into the tenon space, the needle is removed without subsequent suturing, as spontaneous reposition of the eye membranes takes place and self-sealing of the wound. In order to maximize hemodynamic activation, the Alloplant biomaterial is injected onto biologically active points. This effect can be carried out both before the operation and in the postoperative period, with a total number of 1-10 sessions. It is allowed, in satisfactory general condition, the combination of retrosclerotherapy and acupuncture treatment in one day. The time interval between sessions is from 1 to 7 days. For injection, the most optimal is the use of a special form of dispersed biomaterial - "Alloplant for acupuncture administration." It is possible to use other forms of dispersed Alloplant biomaterial, which, according to studies, also have the property of stimulating acupuncture points when they are injected (Alloplant Biomaterials for Regenerative Surgery. Catalog, Ed. By MD, Professor Muldashev E. .R., Ufa, 2007).

For injection, the Alloplant biomaterial is diluted in physiological saline in the ratio: 30-50 mg of biomaterial per 3.0 ml of physiological saline and is injected subcutaneously at points VB1 (Tong Zi Liao), VB14 (Yang Bai), V10 (Tien Zhu), bilaterally (symmetrically on both sides), 0.5 ml in one injection. A dosage of 50 mg of biomaterial is optimal in the treatment of adult patients, and a dosage of 30 mg of biomaterial is preferred in the treatment of children and elderly patients.

The method is illustrated by the following specific examples:

Example 1: Patient T., 25 years old. Ds: OU - high degree myopia. She complained of visual impairment over the past year. A history of scleroplasty OU at 14 years old. At admission: Visual acuity: OD = 0.1-0.2 s corr. Sph -6.5D = 0.9 / OS = 0.1 s corr. Sph -7.5D = 0.8. EFI (electrophysiological study): OD sensitivity - up to 110 μA / OS 126 μA, critical flicker fusion frequency OD-45 / OS-40, total, along 8 meridians, field of view OD -420 / OS -390. With ophthalmoscopy in the area of the optic disc, the myopic cone with pigmentation sites, the reflex from the macula is absent, the retina is stretched, with atrophic foci in the central sections.

The patient was treated according to the claimed method: within 1 week 3 sessions of acupuncture administration of Alloplant biomaterial at points: VB1, VB14, V10. The points were activated bilaterally, the frequency of sessions every other day. At the beginning of the next week, retroscleroplasty was performed on both eyes, and on the first day on OD, then, in a day, on OS. The postoperative period was uneventful. Objectively, 4 weeks after surgery: Eyes are calm. Visual acuity: OD = 0.2-0.3 s corr. Sph -6.5D = 1.0 / OS = 0.2 s corr. Sph -7.5D = 0.9. EFI indicators improved: OD-75 μA / OS- 80 μA, cfcm OD-40 / OS-36, the field of view of OD-450 / OS-425 expanded. The patient was observed for more than 5 years, during which the progression of myopia was not observed, visual functions and fundus picture stable.

Example 2. Patient N., 64 years. Ds: OU: diabetic proliferative retinopathy.

On admission: Visual acuity: OD = 0.03 n / a, OS = 0.05 n / a. EFI: electrosensitive OD - up to 156 μA / OS 140 μA, critical flicker fusion frequency OD-35 / OS-40, visual fields, total over 8 meridians: OD -210 / OS -230. With ophthalmoscopy in the fundus, multiple areas of exudation, hemorrhage and proliferation.

The operation was performed retroscleroplasty according to the claimed method in both eyes, first on OD, the next day OS. The postoperative period was uneventful. Starting from the day after the second operation, 6 sessions of bilateral acupuncture introduction of Alloplant biomaterial were performed at points VB1, VB14, V10. Sessions were held every other day, that is, 1 time in 3 days for three weeks. By the end of the second week after the start of treatment, the patient noted an increase in brightness in the eyes, an increase in the clarity of objects. 4 weeks after completion of treatment with an objective examination: Eyes are calm. Visual acuity: OD = 0.08 n / a, 08 = 0.09-0.1 n / a. EFI: OD electrosensitivity - up to 120 μA / OS 110 μA, critical flicker fusion frequency OD-40 / OS-45, visual fields, total over 8 meridians: OD -235 / OS -260. With ophthalmoscopy, positive dynamics are observed in the fundus in the form of a decrease in hemorrhage and the intensity of exudative-proliferative foci. When examined after 3 months, visual function is stable, fundus picture without negative dynamics.

Example 3. Patient A., 74 years old. D-s: OU - Senile macular degeneration of the retina, dry form. At admission: Visual acuity: OD = 0.06 s corr. +3.5 diopters 0.4-0.5 / OS = 0.03 not corr. EFI: OD sensitivity - up to 145 μA / OS 180 μA, critical flicker fusion frequency OD-35 / OS-30. Fields of view, total OD -415 / OS -365, and on OS the relative central scotoma is 10-15 degrees from the central fixation point. With OD ophthalmoscopy, the optic nerve disc is pale, the boundaries are clear, the phenomena of arteriolosclerosis, arteriolospasm and plethora of the retinal veins, in the central departments, single druses are small and medium in size, without a tendency to fusion, the foveolar reflex is weakened; OS - optic nerve disc disease, retinal vessels with pronounced phenomena of arteriolosclerosis, arteriolospasm and venous congestion, in the macular zone there are many medium and large sizes of drusen with redistribution of pigment, foveolar reflex is absent. The patient was treated according to the claimed method. During the 1st week of treatment - 3 sessions of bilateral acupuncture administration of Alloplant biomaterial, with a periodicity of 1 day. A dilution of 50 mg of Alloplant biomaterial was used per 3 ml of physiological saline. At week 2, the patient underwent retroscleroplasty surgery on the OS and 2 more sessions of acupuncture introduction of Alloplant biomaterial were performed, and during the 3rd week, 2 more sessions of acupuncture exposure were performed, for a total of 7 sessions per treatment course. By the end of the 3rd week, the patient noted, along with an increase in visual functions, an improvement in memory and balance, which is reliable evidence of normalization of cerebrovascular blood flow, including in the pool of the posterior cerebral arteries. When examined 4 weeks after completion of the course of treatment: Visual acuity: OD = 0.1 s corr. +3.5 diopters 0.7 / OS = 0.05 s corr. +2.5 diopters 0.1 (eccentric). EFI: OD sensitivity - up to 125 μA / OS 140 μA, critical flicker fusion frequency OD-40 / OS-35. Some expansion of the visual fields, OD -425 / OS -375, a decrease in the boundaries of the relative central scotoma OS to 5-10 degrees from the central fixation point was noted. With OU ophthalmoscopy, there is a positive trend in the form of a decrease in venous congestion and an increase in the foveolar OD reflex and the appearance of the OS foveolar reflex. Over the course of 6 months of observation, stabilization of the results was observed.

Thus, the proposed invention allows to increase the clinical effectiveness of retrosclerotherapy of the eyes, carried out in case of their chronic diseases associated with hemodynamic disorders in the body.

Claims (1)

The method of retroscleroplasty of eyes with dispersed Alloplant biomaterial, including sequential dissection of the conjunctiva, displacement of the incision relative to the underlying tenon shell parallel to the limb by 3-4 mm, after which the tenon shell is dissected and the dispersed biomaterial Alloplant is inserted into the tenon space, followed by spontaneous reproduction of the shell eyes and self-sealing of the wound, characterized in that the injection is additionally carried out in the pre- or postoperative period the effect on biologically active points with Alloplant for acupuncture administration biomaterial, diluted in physiological saline in the ratio: 30-50 mg of biomaterial per 3.0 ml of saline, and injections are carried out at points VB1 (Tong Tzu Liao), VB14 (Yan Bai ), V10 (Tien Zhu), bilaterally, 0.5 ml per injection, in sessions of 1-10 with a frequency of 1-7 days.