RU2193374C2 - Method for treating ischemic ocular disease and device for its implementation - Google Patents

Abstract

FIELD: medicine, ophthalmology. SUBSTANCE: between two biotransplants one should place a magnetic hermetic pickup unit consisted of two counter-oriented constant magnets at 200 mTl induction. It is fixed at collective surface plate with possibility to rotate. Biotransplants are sutured along the perimeter with uninterrupted suture. Magnetic pickup unit is environmentally isolated. In inferior-external quadrant one should perform the resection of conjunctiva and Tenon's capsule membrane. In subtenon's area one should form a pouch at posterior ocular pole above macular area with the help of a putty knife to place there a double-layer transplant with a magnetic pickup unit. The latter is fixed to episclera and the magnets and their surrounding tissues are affected either frontally or from the side of temporal area with rotating magnetic field from an external inductor. A seance lasts for 5-20 min once or twice daily depending upon disease stage, therapy course includes 10-20 seances with repeating the suggested therapy in 1-2 mo. The method enables to obtain revascularization of ocular tissues, retinal membrane and choroidea in macular area, in particular, by increasing its hemodynamics and oxygenation. EFFECT: improved visual function of retina. 2 cl, 3 dwg, 2 ex

Description

 The invention relates to medicine, and more particularly to ophthalmology.

 A known method of treating ischemic eye disease by revascularization of the choroid using a single-layer biotransplant. (Muldashev ER et al., Surgical treatment of retinitis pigmentosa using the material of the alloplant series. Ophthalmomicrosurgery. -1994. -N 1. -C.32-38). The method is as follows. An incision of the conjunctiva, tenon membrane and sclera is made between the external muscles in the lower-outer quadrant. Using a special spatula between the sclera and choroid (choroid), a pocket is formed. An alloplant biotransplant is implanted into the formed pocket.

 However, this method has a serious drawback. The implantation of an alloplant series biological graft between the sclera and choroid causes an extremely violent proliferative reaction in the choroid, retina, and can result in a number of serious complications, including incurable blindness.

 A device for the treatment of coronary disease of the eye by revascularization of the choroid. The device contains a single-layer biograft in the form of a tennis racket (Muldashev ER et al., Surgical treatment of retinitis pigmentosa using material from the Alloplant series. Ophthalmomicrosurgery. -1994. -N 1. -C. 32-38).

However, this device has significant disadvantages:
- with the constant movement of the eyeball and its membranes, in particular the sclera and choroid, the transplant body shifts towards the "handle of the tennis racket" with its subsequent exit from the formed pocket under the conjunctiva;
- lack of effectiveness in the long term due to the low mass of the biograft in the long term and the lack of an external stimulator.

 The technical result of the invention is the revascularization of eye tissues, in particular the retina and choroid in the macular region, increasing its hemodynamics and oxygenation, and therefore, improving the visual functions of the retina.

 The technical result of the method for the treatment of coronary eye disease is achieved by the fact that before implantation, the biograft is additionally equipped with a second biograft, between which is placed a body of non-ferromagnetic material, in which a magnetic sealed sensor consisting of two counter-oriented permanent magnets with an induction of up to 200 mT, biotransplants according to the perimeter is flashed with a continuous seam, isolating the magnetic sensor from the external environment, then in the subtenon space at the posterior pole of the eye over the poppy a pocket is formed in the ular region into which the proposed two-layer biograft with a magnetic sensor is interfered, fixing it to the episclera and, 2-3 months after the operation, the magnets of the sensor and surrounding tissues are exposed frontally or from the temporal region to an external rotating magnetic field from an external inductor, moreover, the duration of the session, depending on the stage of the disease, is 5-20 minutes 1-2 times a day, and the course of treatment is carried out in 10-20 sessions with repeated treatment after 1-2 months.

 The technical result of the device for the treatment of ischemic eye disease is achieved by the fact that the device is additionally equipped with another biograft, a housing of non-ferromagnetic material is placed between the two biografts, in which there is a magnetic sensor containing two counter-oriented magnets fixed on a common faceplate with the faceplate rotating in case, and to ensure rotation of the sensor magnets, the device is equipped with an external inductor with a rotating magnetic field.

 To implement the method proposed by the authors, a device is developed. The invention is illustrated by drawings.

FIG. 1. Placement of the transplant with an integrated magnetic sensor on the eyeball
Figure 2. Magnetic sensor - top view.

 Figure 3. Cross section of a magnetic sensor.

 At the rear pole of the eye 1 (Figure 1), the first layer of the biograft 2 is placed, a sealed magnetic sensor 3 is fixed on it, which is covered with a second layer of the biograft 4. An inductor 5 is created outside, creating a rotating magnetic field 6. The hermetic magnetic sensor 3 consists of two oriented permanent magnets 7 (Fig.2, 3), placed on a ferromagnetic washer 8 with the possibility of rotation in a sealed enclosure 9.

 In accordance with the invention, the method is as follows.

 Between two biotransplants 2 and 4, a magnetic sealed sensor 3 is placed, consisting of two counter-oriented permanent magnets 7, along the perimeter, biotransplants 2 and 4 are flashed with a continuous seam, isolating the magnetic sensor from the external environment. Next, in the lower-outer quadrant, the conjunctiva and tenon membrane are cut, using a spatula in the subtenon space, a pocket is formed at the posterior pole of the eye over the macular region, into which a two-layer biograft 2 and 4 with an integrated sensor 3 are implanted, fixing it to the episclera and through 2- 3 months after the operation, the magnets 7 of the sensor 3 and the surrounding tissues are exposed to the rotating magnetic field 6 from the external inductor 5. After implantation of the device due to magnetic coupling of the magnetic field of the inductor 5 s the magnetic field of the magnets 6 of the sensor 3 provides rotation of the latter.

 The authors carried out work that allowed to determine the parameters of the acting magnetic fields. When the external magnetic field interacts with the magnetic field of the sensor 3 on the biological tissues of the eyeball and surrounding tissues, an increase in the vascular lumen, blood supply and oxygenation of blood plasma in the vessels and surrounding tissues are provided. An increase in vascular lumen and oxygenation of blood plasma contributes to a statistically significant increase in the linear and volumetric velocity of blood in the vessels supplying the optic nerve, the eyeball and surrounding tissues.

 In addition, the implantation of the proposed device on the episcler of the posterior pole of the eye is accompanied by the release of a large number of physiologically active substances, including serotonin, histamine, kinins, Hageman factor, plasmins, lysosomal enzymes. The release of the above substances leads to vasodilation in the area of extensive aseptic tissue inflammation due to the presence of grafts adjacent to the posterior pole of the eye. The optic nerve, the orbital artery and its main branches, which feed all the tissues of the eye with blood, are located in this zone. The duration of aseptic inflammation continues until there is a transplant - at least 10 years.

 Clinical trials of this method and device have been conducted.

 Example 1. Patient K., aged 45, turned to the IRTC "Eye Microsurgery" for a decrease in vision in the right eye. From the anamnesis it was established that six years ago she was diagnosed with a dry form of involutional chorioretinal macular degeneration in a district clinic. The patient regularly conducted treatment courses three times a year with vitamins, biostimulants and vasoactive drugs, and one of them was conducted in a hospital. Despite the treatment, vision decreased from 0.7 to 0.31. With this eye, the patient could no longer read the newspaper font.

 14.1.1996, the patient underwent surgery according to the above method with implantation of the proposed device. The patient noted the subjective and objective improvement in vision immediately after the operation: it increased to 0.45. After two months, visual acuity was already 0.55. This visual acuity persisted for three months.

 Three months after the operation, the first course of treatment was carried out, including 10 sessions of magnetostimulation for 10 minutes twice a day, then the course of treatment was repeated with the same modes after 2 months. After the first, and more noticeably after the second course of magnetostimulation, visual acuity began to increase and ranged from 0.6 to 0.9. Over the past three years, the patient has conducted 15 courses of treatment. Visual acuity at the last doctor's visit was 0.9. Foveal sensitivity increased from 31 to 33, and the size of the central scotoma decreased from 6.1 to 3.8. The increase in visual function is confirmed by objective examination data. The volumetric blood flow velocity increased in the orbital artery from 5.6 ml / m to 6.65 ml / m, in the ciliary arteries from 1.34 to 1.63, in the posterior short ciliary arteries from 1.9 to 2.37, and rheographic coefficient from 2.6 to 3.8. An increase in the volumetric blood flow velocity also changed the parameters of the eye tissue, so the thickness of the sclera and episclera increased from 0.9 to 1.3 mm, choroid from 0.51 to 0.64 mm, ciliary body from 0.72 to 0.91 mm.

 Given that the pair eye has undergone the disease, it is planned to carry out treatment by a similar method.

 Example 2. Patient S., 52 years old, turned to the IRTC "Eye Microsurgery" with complaints of decreased vision in both eyes. From the anamnesis it was found that 12 years ago the patient was diagnosed with retinitis pigmentosa. The patient was treated in the district and regional hospitals, consulted and underwent treatment with leading specialists in this field, but his vision was constantly decreasing. Over 12 years, visual acuity decreased from 1.0 to 0.2, and the field of view narrowed to 10 degrees in both eyes.

 3.2.1996, the patient underwent surgery with implantation of the proposed device in both eyes. Two months after the operation, the patient underwent a course of treatment that included 10 sessions of magnetostimulation for 20 minutes twice a day, then the course of treatment was repeated with the same modes after two months. Over the past 22 months, the patient has improved and stabilized visual functions: visual acuity at the last visit on December 8, 1998 was 0.4, and the field of view increased from 10 degrees to 25 in both eyes. The improvement of visual functions can be explained by an increase in blood supply to the eye tissue due to an increase in the volumetric blood flow velocity. In the orbital artery, the volumetric blood flow velocity increased from 5.3 to 7.2 ml / m, in the ciliary arteries from 1.33 to 1.79, in the posterior short ciliary arteries from 1.4 to 2.9 ml / m, the reographic coefficient from 2.3 to 3.8. An increase in the volumetric blood flow velocity also changed the thickness of the eye tissues. The thickness of the sclera increased from 0.9 to 1.4 mm, the choroid from 0.52 to 0.89, and the ciliary body from 0.68 to 1.1 mm.

 Thus, the proposed method for the treatment of ischemic eye disease with implantation of the device with subsequent treatment courses by the above method causes aseptic inflammation, which is accompanied by additional vascularization of all structures of the eyeball, including the retina, choroid, sclera, episclera, optic nerve, and surrounding tissues , prolonged release of biologically active substances. The direct action of a rotating magnetic field on blood vessels and hemoglobins with increased oxyhemoglobin stress, an increase in the volumetric blood flow velocity, and therefore, blood supply, have a positive effect on the course of ischemic processes in the tissues of the eyeball and orbit. The proposed method and device allows you to save, and in some cases improve the existing visual functions in patients suffering from coronary eye disease, including such severe diseases of the organ of vision, such as the "dry" form of involutional macular degeneration and pigmentary chorioretinitis.

Claims (2)

 1. A method of treating ischemic eye disease by implanting a biograft in orbit tissue, characterized in that prior to implantation, the biograft is additionally provided with a second biograft, between which a body of non-ferromagnetic material is placed, in which a magnetic sealed sensor consisting of two counter-oriented permanent magnets with induction is placed up to 200 mT, biotransplants around the perimeter are stitched with a continuous suture, isolating the magnetic sensor from the external environment, then in the subtenon space of the upper pole of the eye over the macular region, a pocket is formed in which a two-layer biograft with a magnetic sensor is placed, fixing it to the episclera, and 2-3 months after the operation, the magnets of the sensor and surrounding tissues are exposed to the surrounding magnets by an external rotating magnetic field from an external inducer, and the duration of the session, depending on the stage of the disease, is 5-20 minutes 1-2 times a day, and the course of treatment is 10-20 sessions with repetition of treatment after 1-2 months.  2. A device for the treatment of coronary disease of the eye containing a biograft, characterized in that the device is additionally equipped with another biograft, a housing made of polymer material is placed between two biografts, in which there is a magnetic sensor containing two counter-oriented magnets fixed on a common faceplate with the possibility of rotation of the faceplate in the housing, and to ensure rotation of the sensor magnets, the device is equipped with an external inductor with a rotating magnetic field.

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