Light guides for interstitial laser hyperthermia of intraocular neoplasms and insertion technique

FIELD: medicine.

SUBSTANCE: light guides are inserted into neoplasm transsclerally by an adjustable lanceolate needle and cannulas 23G or 25G perpendicularly to sclera on a line of the greatest diametre of the base and on a line perpendicular diametre at the distance 2.5-3.5 mm in both sides from the centre of tumour base. The depth of light guide insertion is specified from preliminary ultrasound: tumour height at the distance 2.5-3.5 mm on sclera from the centre of tumour basis minus 1.5-2 mm.

EFFECT: possibility for controlled depth hyperthermia, minimum injury of structures and eye tissues in light guide insertion and procedure, elimination of required additional surgeries following hyperthermia, necrosis limitation by tumour volume.

1 ex

 

The invention relates to medicine and can be used in ophthalmology and oftalmologii for interstitial laser hyperthermia of intraocular tumors prequaternary and Equatorial localization.

At the present stage of development of oftalmologii preferred conservative treatment of intraocular tumors, the main requirement which is the principle of maximum radicalism in relation to the tumor with minimal adverse impact on surrounding healthy tissue.

According to the recommendations of the A.F. Brovkina (2002), holding conservative treatment is possible if the greatest diameter at the base of intraocular tumors when postequalization localization does not exceed 13-14 mm, and prominence 6,5 mm

With larger tumors taken to enucleation. However, in 1978 L.Zimmerman and .McLean showed that the frequency of metastases in patients undergoing enucleation higher than in untreated patients. Indicators of perejivaemogo 5-year period after enucleation of the affected eye make up from 50 to 75%, while when using brachytherapy this increases substantially - from 86 to 93% (Eshleman, Approving, 1989).

Based on the above data it becomes apparent the relevance of developing a conservative method is economical treatment of intraocular tumors, in respect of which traditionally are enucleation.

One of the promising methods for the treatment of intraocular tumors, in particular malignant melanoma of the choroid (MX), is photodynamic therapy (PDT). Unfortunately, the efficacy of PDT is limited by the height of tumors that subject experimental research. Thirty-two new Zealand rabbits with pigmented melanomas of the choroid spent PDT (Kim RY; Hu LK; Foster BS; Gragoudas ES; Young LH. Photodynamic therapy of pigmented choroidal melanomas of greater than 3-mm thickness. // Ophthalmology. 1996 Dec; 103(12): 2029-36). The results histomorphologically studies have confirmed the ability of PDT to destroy melanoma of the choroid thickness of not more than 4.6 mm In an earlier similar study (Gonzales VH, Hu LK, Theodossiadis PG, et al. Photodynamic therapy of pigmented choroidal melanoma. // Ophthalmol Vis Sci. 1995; 36: 871-878) was shown the efficacy of PDT in respect of pigmented malignant melanoma of the choroid thickness of not more than 4.8 mm

The effectiveness of brachytherapy MX is 70-73% at five-year follow up [Brovkin A.F., Zaruba GD About the effectiveness of brachytherapy in uveal melanomas. // Oftalmol. Journe. - 1993. No. 1. - P.1-4].

The main condition for successful brachytherapy of intraocular tumors is the absorbed dose calculation. However, to achieve the required dose at the "top" of the tumor in the treatment of intraocular tumors of large size, surface dose opthalmoplegia the ora must be extremely high, which leads to serious complications associated with radiation effects on the structures of the eye. These include:

- iridocyclitis occurs in cases of exposure eyes large doses, when the leading edge of ophthalmoplegia is located close to the ciliary body. Radiation iridotsiklity proceed with hypertension and require intensive treatment (mydriatic, corticosteroids, antihypertensives and others);

- reactive exudative retinal detachment occurs in 43% of patients with large tumors;

beam vasculitis, partial Hemofarm;

- retina and neuromyopathy, neovascular glaucoma is irreversible complications and are respectively 3, 1 and 1%.

The possibility of developing these complications is correlated with the radiation dose, its hardness, size and localization of the tumor:

- radiation cataract;

- radiation necrosis of the sclera [Oftalmologia. Ed. Approving. - M.: Medicine, 2002. - P.132-133].

Interstitial laser hyperthermia has a similar PDT efficiency constraints on the height of the tumor and is not associated with the occurrence of complications inherent in brachytherapy.

Local hyperthermia involves selective heating of the tumor tissue to 43-44°C, at which thermal energy is supplied directly to the target tissues. Experimental studies have allowed the becoming, that tumor tissue is heated to a greater extent than that of the surrounding normal tissue. Effect of hyperthermia on tumor process is determined by the "dose of heat and pH cells. Heat 40-42°C improves blood circulation in tissues, anti-inflammatory and immunomodulatory effects (Gelfond M.L., Mizgirev I.V., Barchuk A.S. et al. Selective laser hyperthermia of malignant neo-plasms: experimental and clinical research. // Proc. of SPIE (Laser use in Oncology II). - 2004. - Vol.4059. - P.13-24), reduces metastasis.

In the temperature range of 42.5-43°C develops the cytotoxic effect caused by thermal inactivation of proteins and damage of the cytoplasmic membrane of the cells of solid tumors (Konoplyannikov A.G. electromagnetic hyperthermia (SHF and UHF bands) in the treatment of neoplastic and non-neoplastic diseases. // Physical medicine. - 1991 - Vol. 1. No. 1. - P.5-11). In addition, by heating the tumor to 42°C (and higher) induced expression of heat shock proteins (HSP 70), followed by the development of local necrosis, leading to the release of these polypeptides in the extracellular environment and the emergence of associative peptides (Osinsky, S., Shidnia N. The 20-th anniversary of the International Clinical Hyperthermia Society (ICHS): experimental and clinical experience. // Exp.Oncology. - 2000. - Vol.22. - P.95-96). HSP, expressed on the surface of tumor cells as antigenpresenting molecules involved in the activation of natural killer cells, T-limpot the tov, act as chaperones for peptides. HSP and their derivatives, coming in the extracellular space, activate natural immune response. So, at the temperature to which the tolerance of normal tissue, irreversible damage to the tumor cells (Seegenschmiedt M.N., Erb J., Sauer R. Interstitial Hyperthermia combined with Radiotherapy: Rational Technology, Clinical Experiance. // Minimal invasive Medicine. - 1993. - Vol.4. No. 3. - P.22-34).

In modern Oncology interstitial hyperthermia treatment of tumors of soft tissue, head and neck, breast, pelvic cavity and extremities. To conduct interstitial hyperthermia in these cases, there are different fibers tested technique of the procedure, including how the introduction of fibre-optic cables.

The use of interstitial hyperthermia in ophthalmology is complicated by the inaccessibility and small size tumors. Another problem is the lack of optical fibers, modified for carrying out hyperthermia treatment of intraocular tumors.

Consequently, it is important to develop a way of introduction of optical fibers for interstitial laser hyperthermia treatment of intraocular tumors, during the procedure given the lack of direct access and small size of the tumor, as well as modification of optical fibers to allow for hyperthermia in the volume of tumors at p is slicnoj its depth.

The known fibers (400 and 600 μm) with diffusers for conducting interstitial operations http://www.laserstar.ru/pr_instr_acces.htm). However, the use of these fibers is impossible to accurately control the depth of insertion of the optical fiber and, accordingly, the depth of which is hyperthermia.

Authors unknown how the introduction of optical fibers for interstitial laser hyperthermia of intraocular tumors.

The objective of the invention is a modification of the optical fibers for interstitial laser hyperthermia and how their introduction in pre - and Equatorial localization of intraocular tumors.

The technical result is the possibility of hyperthermia at a controlled depth, minimum damage to the structures and tissues of the eye with the introduction of fiber optic cable and the procedure, no need for an additional surgical procedures after hyperthermia, limited necrosis of the tumor volume.

The technical result is achieved due to the fact that the fibers graduated with a multiplier of 1 mm and have a limiter; the fibers are injected into the tumor transscleral by spears adjustable length and needle 23 G or 25 G perpendicular to the sclera on the line of greatest diameter at the base and on a line perpendicular to the diameter on the Sam is anii 2.5-3.5 mm in both directions from the centre of the base of the tumor and the depth which is determined according to the preliminary ultrasound: the height of the tumor at a distance of 2.5-3.5 mm in the sclera from the centre of the base of the tumor minus 1.5-2 mm.

The light guide (⌀400 μm, ⌀600 μm) with a diffuser graduated with a multiplier of 1 mm from the cone. On the light guide wearing the limiter, for example, in the form of a ring made of rubber. Moving the limiter through the light, set the depth to which it is introduced into the structure of the tumor.

The fibers enter the following way.

Transscleral diaphanoscopy precise localization and size of the tumor, define the boundaries of the projection of the base of the tumor on the sclera and selects the largest diameter of the tumor and the diameter perpendicular to it. On the sclera outline the point of introduction of optical fibers: the line of greatest diameter at the base and on a line perpendicular diameter at a distance of 2.5-3.5 mm in both directions from the centre of the base of the tumor. Then the structure of intraocular tumors injected optical fibers.

For insertion of optical fibers using a spear with a screw adjustment of the length of the cannula tool 23 G (for the light ⌀600 μm) or 25 G (for the light ⌀400 μm). Install the necessary length of the spear (length extrascleral part of the cannula + the thickness of the sclera + the depth to which the fiber is inserted into the tumor). Then with spears, installed in the channel to Nuli, perform sclerotomy and enter the spear for the entire length of the structure of the tumor is perpendicular to the sclera. The spear is removed from the channel of the cannula and in it enter the light guide.

The maximum depth to which the light is injected into the tumour, is determined according to the preliminary ultrasound (gray-scale B-scan): the height of the tumor at a distance of 2.5-3.5 mm in the sclera from the centre of the base of the tumor minus 1.5-2 mm For exposure of the entire tumor volume (maximum depth, in the middle part, and so on) the depth of insertion of the optical fibers can be adjusted by typing in the channel to a maximum depth of at 2/3 of the maximum depth at 1/3. To control the depth of insertion of the optical fiber using the limiter.

After the introduction of the optical fibers conduct interstitial laser hyperthermia of the tumor, then remove the fiber and the cannula, sclerotome not taken.

For carrying out hyperthermia with multiple fibers simultaneously use multiple lasers or optical coupler. The invention is illustrated by the following data.

Clinical example. Patient N., 69 years. Entered in the Kaluga branch of IRTC "eye microsurgery" suspected tumor of the choroid of the right eye. According to the results of a comprehensive survey was diagnosed with melanoma of the choroid OD. Localization of the tumor - temporal in the Equatorial about the Asti. The size of the tumor by ultrasound B-scan: base 10,0 x 14,0 mm, the size of prominence 7,5 mm During PHAGE was detected characteristic mottled fluorescence.

Informed consent was obtained from the patient to treatment of melanoma of the choroid method for interstitial laser hyperthermia.

Interstitial laser hyperthermia of the tumor was performed using an optical fiber 600 μm, which was introduced by the proposed method through a 23 G needle, the distance between the optical fibers was 5 mm Hyperthermia was performed throughout the tumor volume, WDIV fiber optic cables to a maximum depth of at 2/3 of maximum depth, and 1/3. The depth of insertion of the optical fibers was controlled by the limiter, made in the form of rubber rings.

Immediately after hyperthermia and removal of the optical fibers in the sclera visible dot sclerotomy no signs of damage to the surrounding tissue. Sclerotomy not sutured.

During the control study within 6 months ophthalmoscopically on the location of the mass was determined chorioretinal lesion with heterogeneous pigmentation with residual prominence to 1.4 mm ultrasound mode power Doppler mapping of intratumoral blood flow in the projection of the hearth was completely absent. The observation period of 1.5 years with no signs of odolganova growth.

Hyperthermia with the introduction of the optical fibers of the proposed method has spent 4 patients with intraocular tumors. Used the optical fibers 400 μm and 600 μm, which was introduced through the needle 25 G and 23 G, respectively, the distance between the fibers ranged from 5 to 7 mm. in Neither case did not need additional surgical procedures after hyperthermia, signs of damage to the eye tissue outside the tumor was not found.

The follow - up period of up to 18 months. In two cases achieved complete in two or partial destruction of the tumor by ultrasound.

Thus, the inventive method provides the possibility of hyperthermia at a controlled depth, minimum damage to the structures and tissues of the eye with the introduction of fiber optic cable and the procedure, no need for an additional surgical procedures after hyperthermia, limited necrosis of the tumor volume.

The method of introduction of optical fibers for interstitial laser hyperthermia treatment of intraocular tumors, namely, that light injected into the tumor transscleral by spears adjustable length cannula 23G or 25G perpendicular to the sclera on the line of greatest diameter at the base and on a line perpendicular diameter at a distance of 25-3,5 mm in both directions from the centre of the base of the tumor and the depth which is determined according to the preliminary ultrasound: the height of the tumor at a distance of 2.5-3.5 mm in the sclera from the centre of the base of the tumor minus 1.5-2 mm.



 

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