Method for applying enzymotherapy

FIELD: medicine.

SUBSTANCE: method involves making sclera pierce with injection needle 3-4 mm far from limb and then proceeding along vitreous body periphery towards epiretinal space. Collalysinum is introduced through the injection needle at a single dose of 2-10 CU directly into fibrous tissue or pouring over it. Severe fibrous transformations being the case, Collalysinum is introduced through needle bent at an angle of 30-40° with epiretinal membrane being mechanically separated or schwartotomy being concurrently done with needle tip.

EFFECT: enhanced effectiveness of treatment; minimized vitreous body injury; increased bioavailability of the preparation; accelerated treatment course.

4 dwg

 

The invention relates to the field of medicine, ophthalmology and relates to methods for enzyme therapy.

There are various ways enzyme therapy, which consists in intraocular introduction of enzyme preparations: in front of the camera, lens (intramental) and in the vitreous body (intravitreal) [1-3]. All of these methods are injection and are designed to create a desired therapeutic concentration of the enzyme preparation in pathologically altered the structure of the eyeball with minimal impact on the edge of the eye tissue.

All known methods for enzyme therapy by intraocular injection are classified depending on the localization of pathological changes in the eye. If the pathologic lesion appeared in the cornea, iris or anterior chamber of the eye, the enzyme is injected directly in front of the camera [1-3]. So, when corneal opacities of various etiologies (keratitis, wounds and burns of the cornea, disease, corneal transplant) the drug is injected in front of the camera last. This is because the contact of the enzyme with the cornea can be from two sides: both outside and inside. In this case, enzyme therapy start out with a less invasive extraocular methods of administration, which include the following: using glass the x medical films, installation, subconjunctival and parabulbar injection [4-7]. When plastic iridotsiklite when suffering iris, ciliary body, and for diabetic patients should be aware of posterior synechia, inflammatory exudate in the anterior chamber and the formed film in the area of the pupil. To do this in front of the camera administered proteolytic enzymes [1-3, 4-7]. Primary open-angle glaucoma, as evidenced by morphological and histological methods, causes degenerative and sclerotic changes in the ways of aqueous outflow [8, 9]. This leads to the formation of scar tissue with impaired activity of the native enzyme system, and therefore is substitution proteolytic enzyme therapy in the form of the introduction of kulalisena in front of the camera, according to Iauaeoeaiinou (1998). In addition, when giveme (hemorrhage in the anterior chamber) introduction enzymes in front of the camera is considered to be more rational than under the conjunctiva. Especially when total hemorrhage, leading to secondary glaucoma [10, 7]. High efficiency washing the front camera enzyme solutions at giveme was reported by many authors: Rakusin (1971), D' Abbrosio et al. (1975), T.Starck et al. (1995). Creating inside the lens high concentrations of proteases due to their entering from the outside can contribute to the full UDA the structure of the lens fibers. This is the so-called incrementally the introduction. To this end, in the equator of the capsular bag of the lens, many researchers have introduced lekozim and collalysin during extracapsular cataract extraction. Long-term results showed high efficiency of enzymes [11, 12].

There is a method of conducting enzyme therapy, in which the enzyme preparations intravitreal injected into the vitreous body. Recently, this method began to be used in the case of (hemorrhage in the vitreous and vitreoretinal fibrosis (fibrosis of the vitreous body and retina) of various origins [1-7, 13-20]. These pathological changes are the most frequent and severe complications of diabetes and the eye injury. This is due to the fact that in the case of the almost total use of enzymes in the form of a subconjunctival injection and injection under the tenon capsule did not give effective results [21-23]. In this regard, there is a need to introduce enzyme preparations directly into the vitreous body of the eyeball.

In this method, the introduction uses a variety of proteolytic enzymes: collalysin, Gamesa, streptokinase, urokinase, fibrinolizin and others [1-3, 13,15, 18, 20-30]. Now widely used collagenase having the ability to lyse fibrous tissue [1-7, 13-20]. This enzyme is known from the quality production called "collalysin and studied at subconjunctival, parabulbar, retro-bulbar methods of administration; and by electrophoresis and phonophoresis [1-3].

As for the dosage of a single intravitreal injection of kulalisena, in the literature there are various data: from 1-2 KE 10 KE [1-4, 13-16, 31].

According to known literature data, many researchers intravitreal impose other drugs (antibiotics, hormones etc) in various diseases of the eye [24, 32-34].

The main disadvantages of methods of enzymatic therapy through the introduction of proteolytic enzymes into the vitreous body is that this method does not provide the necessary bioavailability of the drug in the posterior segment of the eye (remains intact epiretinal space where a lot is formed fibrous tissue). In this context, many researchers have to repeat the introduction of the enzyme [1-3, 15, 17]. And with the re-introduction of drugs into the vitreous body has a probability of damage and the associated consequences.

Closest to the proposed subject of the invention is a method of conducting enzyme therapy by intravitreal injection of kulalisena with the aim of conservative treatment of traumatic case of the proposed Danilychev VF [2], according to which the enzyme preparation collalysin dose of 1 is E repeatedly injected into the vitreous body to eliminate massive hemorrhages in the vitreous body. This manipulation is performed under local anesthesia by instillation of a 1% solution dikaina, the eyeball is fixed by imposing on him wearechangela, then WCOL insulin needle in the sclera 3-4 mm from the limbus (where the projection of the flat part of the ciliary body). Next, the needle is held to the Central departments of the vitreous body and collalysin in the dosage of 1 KE is injected directly in its center. When clinical necessity manipulation repeat.

However, this technique has the following disadvantages:

1. When injected into the vitreous body has a probability of damage and the occurrence of associated consequences.

2. Collalysin causes enzymatic dissolution of the vitreous body and almost no effect on the epiretinal tissue: vitreoretinal swarthy and epiretinal membrane.

3. Low dosage of the enzyme does not provide the desired effect lizirovania fibrous tissue.

4. Due to the fact that the bioavailability of the drug is lower than with epiretinal the introduction of the drug, have to be repeated introduction from one to several times, which can lead to such complications as bleeding from damaged blood vessels.

5. Almost always followed by intravitreal injection of kulalisena vitrectomy is the surgical removal of the vitreous body, therefore, proposed the first method is not effective enough.

A new technical challenge is reducing the number of relapses, complications during and after injection of enzyme preparations; reduction of terms of treatment of patients; the more persistent therapeutic effect; the possibility of deferral or exclusion holding intraocular surgery patients with proliferative diabetic vitreoretinopathy and traumatic lesions of the eye.

To solve the problem in the way of enzyme therapy, which consists in the introduction of kulalisena through the injection needle, vcol which is carried out in the sclera at a distance of 3-4 mm from the limbus, which then hold on the periphery of the vitreous body, and then fail to epiretinal space, and the enzyme preparation at a dose of 2-10 KE once injected directly into fibrous tissue or pour out upon her, and with rough fibrous changes of the enzyme was carried out through a needle bent at an angle of 30-40 degrees tip, which simultaneously carry out the mechanical separation of epiretinal membranes or vartotojo.

The method is as follows.

Enzyme therapy according to the proposed method is carried out in the conditions of the treatment room under the control of the head binocular Ophthalmoscope (NB-2) with lens +20,0 D. Pre-diluted enzyme preparation collalysin in a dosage of from 2 to 10 To the in 0.1 ml of isotonic sodium chloride solution. Then the prepared enzyme solution trying to enter into an insulin syringe, put intradermal needle from dvukhmillimyetrovogo syringe size 0,63·32 mm At the maximum mydriasis patient will triple intelliroute anesthetic with an interval of 3-5 minutes (0.5% of p-p dikaina or 0.4% p-p of isocaine). Then fix the eyeball by imposing on him wearechangela. Then produce vcol needle in the sclera 3-4 mm from the limbus (where the projection of the flat part of the ciliary body) on 10-11 hours (figure 1). Next, a needle carried out in epiretinal space (figure 2) and the enzyme is injected directly into epiretinal fibrosis (membrane, swarty) or simply pour out on them (figure 3). If you have coarse fibrous changes, the tip intradermal needle before injection of the drug is bent at an angle of 30-40 degrees (figure 4)that allows the injection of the drug at the same time mechanically to hold the office of epiretinal membranes or vartotojo.

For the introduction of drugs (enzyme preparation of kulalisena) applicants was selected anatomical region of the eye - epiretinal space, which accommodates the liquid volume of 0.1 ml In this space, diabetes and injury in the ground and formed fibrotic changes in the form of vitreoretinal commissure and epiretinal membranes. With the introduction of Epirus is tinline space collalysin is delivered to the posterior segment of the eye, thereby increasing its bioavailability in connection with the maximum approximation of the drug to pathologically altered structures, at the same time, the vitreous body remains almost intact.

Dosage of kulalisena (2-10 S) selected on the basis of analysis of data obtained during the clinical application of the method (depending on the extent and prevalence of fibrotic changes)as the most efficient and therapeutically more effective. Dose less than 2 KE was insufficient to lizirovania fibrous tissue and dose more than 10 KE did not give additional therapeutic effect. As shown in clinical tests, the proposed method allows to obtain a stable treatment effect with a single administration of a medicinal product, which contributes to a significant reduction in the morbidity method.

The proposed method can successfully be used for dissolution of collagen - the main extracellular component vitreoretinal commissure, epiretinal membranes, due to shrinkage which occurs traction dislocation and retinal detachment, and to a lesser extent for resorption of the case.

According to the proposed method was treated 86 patients with proliferative diabetic retinopathy and traumatic lesions of the eye, of which 23 people with case (partial is hydrated and total); 2 people with preretinal hemorrhages and 61 people with proliferative changes (vitreoretinal fibrosis of varying severity and prevalence have 10 of them met epiretinal membrane). Term observation of patients was 3 years. The high efficiency of treatment of such patients by reducing the number of relapses compared with the control group by 65.2% and complications - 48.5%. In 26 cases was delayed operation (for a period of 1.5 months to 2 years); and 60 patients surgical treatment is generally not required (increased visual acuity in this group occurred in all cases from 0.1 to 1.0). Complete resorption of preretinal hemorrhages and hemophthalmos were observed in 14 patients, partial - 11; all patients (86 people) noted the lizirovania vitreoretinal fibrosis (from 30 to 95% of baseline); in all 10 cases with epiretinal membranes we were able to separate and remove them. In addition, there were no cases of anatomical damage surrounding this space normal structures of the eye.

Example 1. Patient B., 54 years old. The diagnosis of proliferative diabetic retinopathy, traction retinal detachment of the left eye. Visual acuity of the left eye = 0,02-corrected Sph+2D=0,08. December 25, 2003 it was held featur who controls the method according to the invention. Injection of the enzyme preparation in a dose of 2 KE was conducted in an outpatient setting under local anesthesia (instillation of 0.5% R-RA dikaina). When viewed 26 December 2004 left eye serene, the fundus of the eye: the retina is adjoined throughout, traction mechanism decreased (40%) from the original due to softening, loosening, and resorption of fibrous tissue, which is confirmed by ultrasonic-scan of the eyeball. Monitoring the patient for 2 years. In a stable condition, visual acuity at the last inspection = 0,4-corrected Sph+2D=0,6; the retina is adjoined throughout.

Example 2. Patient W., 51. The diagnosis of proliferative diabetic retinopathy, preretinal hemorrhage in the macular region of the left eye. Visual acuity of the left eye=0,01 eccentric. September 20, 2004, it was held, the proposed method of introduction of the enzyme (10 EC) according to the invention. This technique was performed in an outpatient setting under local anesthesia (instillation of 0.4% R-RA inakaya). During the inspection the next day the left eye of calm in the vitreous body lysed blood, the fundus of the eye is not visible yet. September 21, hemophthalmus fully visualized (90%), the fundus of the eye is well visualized, which is confirmed by ultrasonic-scan of the eyeball. Patient follow-up was 1 the od 5 months visual acuity at the last inspection of 0.5-corrected Sph+1D=1,0.

Example 3. Patient W., 20 years. The diagnosis of proliferative diabetic retinopathy, partial hemophthalmus, epiretinal membrane in the right eye. Visual acuity of the right eye = 0,1 not corrects. March 21, 2004, it was held, the proposed method according to the invention. The drug was administered in the dose of 10 KE. This intervention was conducted in an outpatient setting under local anesthesia (instillation of 0.4% R-RA inakaya curved (under 30-40 degrees) intradermal injection needle. During manipulation under the influence of the enzyme occurred softening of the epiretinal membrane. We managed to separate her from the retina and remove. When viewed 22 March 2004 right eye calm, hemophthalmus began to dissolve, and the fundus of the eye became better be viewed, epiretinal membrane is absent, and therefore the likelihood of coarse fibrous tissue is excluded, which is confirmed by ultrasonic-scan of the eyeball. Monitoring the patient was 1 year and 9 months. Positive dynamics was recorded throughout the observation period. Visual acuity at the last inspection =0,6-corrected Sph-2D=0,8.

Thus, the application of the proposed method allows to reduce the number of relapses, complications during and after injection f is mantyh drugs; to shorten the time of treatment of patients; to obtain a more stable therapeutic effect; to postpone or eliminate the conduct of intraocular surgery patients with proliferative diabetic vitreoretinopathy and traumatic lesions of the eye; and it is promising for the introduction of other medicines.

Literature

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Way for enzyme therapy in patients with proliferative diabetic retinopathy or traumatic lesions of the eye, which consists in the introduction collisionA through the injection needle, vcol which is carried out in the sclera at a distance of 3-4 mm from the limbus, characterized in that the needle then hold on the periphery of the vitreous body, and then fail to epiretinal space the TSS and collalysin at a dose of 2-10 KE once injected directly into fibrous tissue or pour on it and with rough fibrous changes of the enzyme was carried out through a needle bent at an angle of 30-40° tip which simultaneously carry out the mechanical separation of epiretinal membranes or vartotojo.



 

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Safety syringe // 2255768

FIELD: medicinal equipment, in particular, safety syringes.

SUBSTANCE: safety syringe has cylinder with axial through opening, retainer provided within front end of cylinder, piston, needle hub, and needle. Piston positioned for sliding inside cylinder is equipped with sealing rubber member, head and flange disposed on piston in opposed relation to head. Needle hub is detachably engaged with cylinder and is provided with axial opening corresponding to that of cylinder and communicated therewith, and feeding opening adapted for communication with axial openings of needle hub and cylinder and for providing insertion of piston head. Needle has sleeve engaged with front head part of needle hub, and metal pipe engaged with sleeve. Piston has neck portion defined at its front end and arranged so that rubber sealing member tightly adheres thereto, and spatially inclined teeth. Head is made conical. Needle hub has conical front end with protrusions mating with cylinder retaining device upon rotation of cylinder. Slots are provided for engagement with inclined teeth. Bead provided in peripheral portion of feeding opening is mating with piston conical head. Protrusions are released from finger clamps upon rotation, when inclined teeth are engaged with slots.

EFFECT: simplified construction and convenient use.

4 cl, 12 dwg

FIELD: medical engineering.

SUBSTANCE: device has sealed reservoirs, containing substances, and piston mechanism, having piston cylinder, piston and piston rod. Device for moving liquid between the reservoirs is mounted in piston cylinder lumen. The device has separating piston and compression unit arranged in series. The unit designed as casing or carcass is mounted in projection of its external cylindrical part along the perimeter. Hollow internal lumen of has exit to piston projection inward from its external perimeter. The separating piston makes two connections with the piston cylinder and compression unit at the same time. The separating piston is movable into compression unit lumen with compression or change in shape taking place at the same time. The compression unit allows to make communication between reservoirs.

EFFECT: simplified design.

5 cl, 8 dwg

The invention relates to medical equipment, namely, devices for injection in a syringe with drug substance

Syringe // 2197278
The invention relates to medical engineering, in particular to injection devices single use

Carpool // 2180860
The invention relates to medicine, namely to medical technology, and is intended for local anesthesia

FIELD: medicine, gastroenterology.

SUBSTANCE: at the background of aglutenic diet and complex therapy including antisecretory, antibacterial and enzymatic preparations one should introduce biologically active additives "Normoflorin Lacto" per 20 ml twice daily and "Normoflorin Bifido" per 20 ml once daily for the period of 28-30 d. The innovation enables to efficiently correct psychoemotional status in such category of patients due to simplifying the method of therapy at excluding side effects associated with applying psychotropic preparations.

EFFECT: higher efficiency of correction.

5 ex, 1 tbl

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