Endoluminal laser ablation apparatus and method of treating veins

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. An apparatus comprises: a flexible wave guide with a long axis, a proximal end optically connected with an emitter, a distal end placed in a blood vessel and comprising an emitting surface producing from the emitter towards the long axis of the wave guide on a surrounding vascular wall region extending within the angular range; there are also provided enclosing assemblies comprising the emitters and generating a gas interface to refract the laser light towards the long axis of the wave guide. A version of the enclosing assembly is a lid rigidly attached to the wave guide, sealed and transparent to the laser light. The method for endoluminal therapy of a blood vessel involves: introducing the wave guide; transmitting the laser light through the wave guide; emitting the laser light simultaneously towards the surrounding vascular wall region extending within the angular range approximately of 360°.

EFFECT: using the given group of inventions enables extending the range of techniques and improving the safety and efficacy of the endoluminal laser ablation.

23 cl, 11 dwg

 

Cross-reference to priority application

[0001] This patent application is claimed priority under the patent application U.S. No. 12/395,455, filed February 27, 2009, entitled "Device for endoluminal laser ablation and treatment of veins", provisional patent application U.S. No. 61/104,956, filed October 13, 2008, entitled "Device for endoluminal laser ablation and treatment of veins", provisional patent application U.S. No. 61/079,024, filed on July 8, 2008, entitled "Radially radiating device and a method of treating veins", and provisional patent application U.S. No. 61/067,537, filed on February 28, 2008, entitled "Device for quick insertion and improved method of laser treatment vessels, each of which is fully incorporated into the present application by reference and is a part of the present disclosure.

Prerequisites to the creation of inventions

The scope of the invention

[0002] the Present invention relates to endovascular laser treatment, in particular, to the treatment of vascular diseases, such as venous insufficiency, with the help of laser energy from the fiber.

Statement of disclosure of information

[0003] the Venous system of the lower extremities of a person essentially consists of a system of superficial veins and deep veins, United perforating the veins. The system of superficial veins contains large and small saphenous vein and the deep vein system contains front and rear tibial veins, which converge, forming the popliteal vein near the knee. The popliteal vein, in turn, goes into the femoral vein, when it joins the small saphenous vein.

[0004] the Venous system contains valves that help ensure one-way blood flow back to the heart. Venous valves are butterfly valves, where each leaf forms a reservoir of blood. Bivalve venous valves reduce their available surface in the direction toward each other under pressure reverse flow. During normal operation, the reverse flow is prevented, and only direct blood flow to the heart. Butterfly valve becomes weak when the flaps are unable to properly close under the pressure of the reverse flow and allow reverse flow. When the reverse flow on the lower areas increases venous pressure, which, in turn, leads to dilatation and failure of other valves.

[0005] the Failure of the valves, called venous insufficiency is a chronic disease that can cause coloration of the skin, varicose expansion of veins, bol is, swelling and ulcerations. Varicose veins are blood vessels that have enlarged, twisted, and walls ceased to be elastic. Due to expansion of blood vessels valves are not fully closed, and veins lose their ability to carry blood back to the heart. This leads to accumulation of blood inside blood vessels, which in turn leads to a further increase and the curvature of the veins. Varicose veins are usually blue or purple color and may protrude in a curved form through the skin surface, resulting in the characteristic unpleasant appearance. Varicose veins are usually formed in the subcutaneous veins of the legs, at high pressure from a standing person. Other types of varicose veins include venous lakes, reticular veins and telangiectasias.

[0006] There are several methods of treatment for these types of vascular diseases. Some of these methods are only aimed at the relief of certain symptoms, and do not eliminate varicose veins and prevent their re-occurrence. These methods include raising the legs in the supine position or when using a footrest in a sitting position, elastic stockings, and special exercises.

[0007] Varicose veins are often treated by the method of removing diseased veins. In the treatment given by way of the blood, which could leak through remote Vienna, forced to flow on the remaining healthy veins. To remove the problematic veins can be used in a variety of ways, including surgery, sclerotherapy, electroacoustic and treatment with a laser.

[0008] In sclerotherapy uses a thin needle to inject a solution directly into the vein. This solution irritates the lining of the vein, causing it to swell and the blood to clot. Vein turns into scar tissue, which eventually can become invisible. Some doctors use sclerotherapy to treat varicose and spider veins. Today commonly used sclerosant include hypertonic saline or Sotradecol (Sotradecol™) (tetradecanamide sodium). The sclerosant acts on vnutrenniy the lining of the walls of the veins, causing them to close and block the blood flow. Sclerotherapy can lead to various complications. People suffering from allergies, can detect an allergic reaction, often very strong. If the needle is not correct, sclerotioides tool can burn the skin or leave it permanent mark or stain. In addition, sclerotherapy can sometimes lead to thrombus formation or moving of blood clots. According to the about some studies of large varicose veins using sclerotherapy may be more prone to re-open, and so the treatment sclerotherapy is usually limited to the veins below a certain size.

[0009] the Extirpation of the veins is a surgical procedure used to treat varicose veins under General or local anesthesia. Problematic veins are removed from the body by passing a flexible device through the vein and its removal through the incision in the groin area. Smaller branches of these veins are also removed such device or removed through several small incisions (i.e. outpatient phlebotomy). Then Vienna, United with the deep veins, pererezaetsya.

[00010] One of the disadvantages of removing the veins is the fact that it can lead to scarring at the site of the incisions and sometimes can cause the formation of blood clots. Another disadvantage is that the extirpation of the veins can be painful, time-consuming and can have a long recovery period. Another disadvantage of removing the veins is that their implementation can be damaged collateral branches remote veins, which can bleed and, in turn, lead to bruising or other complications such as blood loss, pain, infection, nerve damage and swelling. Another disadvantage of removing the veins is that due to the damage to the treated area p is the patients can experience pain and discomfort for several hours or even several days after surgery. Another disadvantage of removing the veins is that they may have other negative side effects associated with the fact that such surgical procedures are performed under General anesthesia, including nausea, vomiting and the risk of infection of the wound.

[00011] Another well-known method for the treatment of venous insufficiency is the use of high frequency (RF RF). An example of high-frequency method described in patent application U.S. No. 2006/0069471, Parley, etc. Through the catheter into the vein is entered electrodes that are in contact with the wall of the vein and is pumped through the high-frequency energy with the aim of selective heating of the vein walls. High-frequency power is supplied directionally through electrodes on portions of the vein walls in contact with the electrodes, to cause local heating and fibrosis of the venous tissue. One of the drawbacks of high-frequency methods is that they require constant contact between the high-frequency electrodes and the wall of the vein and essentially serves energy only through these points of contact. Another disadvantage of high-frequency methods is that they can take considerably more time and cause more stress for the patient than is desirable. Another disadvantage of high-frequency methods is that the high-frequency catheter and the electrodes can be is relatively difficult and more expensive to produce, than desirable.

[00012] Another known minimally invasive treatment for varicose veins is endoluminal laser ablation. During the usual known procedures endoluminal laser ablation of veins to be treated, with stiletto-catheter introducing the optical fiber. Fiber optic filament is provided with a flat radiating surface at the distal end. Approximate known procedure endoluminal laser ablation contains the following stages. First, in the vein to be treated, is introduced guidewire, preferably using an injection needle. Then wire the conductor allowed stiletto-catheter, and conduct him to the place of treatment. Then the guidewire is removed, leaving the stiletto-catheter in place. Then through stiletto-catheter is fiber (connected to the laser source), which is located in such a way that a flat radiating surface at the distal end of the fiber and stiletto-catheter are in one place. After that, the tissue surrounding the vein to be treated is subjected tumescent anesthesia. Before the laser treatment, stiletto-catheter is pulled back from the flat radiating surface by a distance sufficient to prevent the emitted laser energy to damage the catheter. Then starts the laser emitting laser the th energy through a flat radiating surface in the blood and/or the wall of the vein opposite the radiating surface. While the emitted laser energy, the laser fiber and the stiletto-catheter divert to implement treatment and closure of the vein at the site of the desired length. The laser energy is absorbed by the blood and/or tissue of the vein walls, and, in turn, causes thermal damage and causes fibrosis of the vein.

[00013] U.S. Patent No. 6,200,332, Del Giglio, describes an example of the known device and method of subcutaneous laser treatment using the minimum insertion at the site of treatment. Common abnormality of blood vessels, such as disorders of the capillaries, stellate hemangioma, hemangioma and varicose veins can be removed selectively. The structure of the vessels of the needle is injected, and the target abnormality exposed to laser radiation. The device allows to orientate and position delivering the laser fiber during treatment. The extension allows you to maintain the fiber in a fixed position relative to the handheld unit and at a fixed distance from him, allowing the user to understand how deep the fiber is introduced into a vein.

[00014] U.S. Patent No. 6,398,777, Navarro and others, describes another procedure endoluminal laser ablation, in which subcutaneous access to the cavity of the vein can be achieved using angiocatheter, through which is inserted a strand of fiber. Filament fiber has a tip without a cover having a flat radiating surface. According to the patent '777 vein is compressed manually, for example by hand or by using a compress, in order to bring it into contact with a flat radiating surface of the tip of the fiber. Laser energy is served in the form of high-energy pulses at the site of the vein walls in contact with the bare tip fiber. The wavelength of the laser energy is in the range from about 532 nm to about 1064 nm, and the duration of each pulse is between about 0.2 sec. up to about 10 seconds. Each pulse delivers from about 5 watts to about 20 watts of energy to the wall of the vein. According to the patent '777 and other well-known procedures endoluminal laser ablation is supplied energy is sufficient to ensure that damage to the entire wall thickness of the veins, which ultimately leads to fibrosis of the vein walls and the closure of the great saphenous vein.

[00015] In accordance with the patent '777 known supply of relatively high levels (i.e., not less than 80 j/cm) to improve the success of treatment of venous insufficiency of the subcutaneous veins of the endoluminal laser ablation Timperman, etc. indicate that intravenous treatment of saphenous vein laser is particularly successful when applying doses greater than 80 j/see Timperman and other collected data relating to the length of the exposed treatment of Vienna and the total amount of energy used based on 111 processed is Yong. The wavelength of the used laser energy was 810 nm or 940 nm. 111 treated veins, 85 remained closed (77,5%) in the subsequent period. In this group successfully treated veins average level of the supplied energy was 63,4 j/see In a group of 26 unsuccessfully treated veins average level of energy used was 46.6 j/see patients who received a dose of 80 j/cm and higher, unsuccessful treatment have been identified. R. Timperman, M. Sichlau, R. Ryu, "an increased level of energy increases the success of treatment method of endovenous laser treatment of venous insufficiency saphenous vein", Journal of vascular and interventional radiology, volume 15, edition of 10, str-1063(2004).

[00016] One disadvantage associated with this and other known methods of treatment endoluminal laser ablation is that the laser light is output only through a very small flat radiating surface uncovered the tip of the fiber. As a result, essentially only a very small localized area of the blood and/or walls of Vienna facing the flat radiating surface directly receives the emitted laser energy at a specific point in time. Another drawback of these known devices and methods for endoluminal laser ablation is that laser radiation from a flat radiating surface is rnost fiber is exclusively directed forward. Accordingly, essentially the radiation is not directed radially or laterally from the tip of the fiber, resulting laser radiation is relatively localized. An additional disadvantage is that a relatively high level of energy supplied to Vienna, creates an area of significantly increased temperature, which can, in turn, increase the corresponding pain in the surrounding tissues. Relatively high levels of supplied energy can also lead to increased thermal damage to surrounding tissues. The stronger temperature damage, the higher the chance of pain after the procedure, the appearance of hematomas and occurrence of paresthesia. Paresthesia is an abnormal and/or discomfort caused by nerve damage. Another disadvantage is that such a relatively high level of energy delivery and/or localized concentration of the laser radiation can lead to perforation of the veins. As a result, such known procedures endoluminal laser ablation may require the use of large amounts of anesthetic, for example, local tumescent anesthesia, more time, and can lead to increased stress for both the patient and the treating physician.

[00017] Another drawback of endoluminal laser the ablation is that uses the tumescent method, requiring a significant amount of tumescent anesthesia. For example, a typical known method of treating endoluminal laser ablation requires at least from about 100 ml to about 300 ml or more tumescent anesthetic agent depending on the length of the treated vein. Tumescent anesthetic agent is injected into the tissue along the entire length of the vein. In some cases, tumescent anesthetic agent is injected into perivenous cavity bounded by one or more fascial sheaths surrounding the vein. In other cases, tumescent anesthetic agent is injected in the foot tissue surrounding the vein. Tumescent anesthetic agent is normally essentially consists of dilute concentrations of lidocaine and epinephrine in saline solution. One of the drawbacks of such tumescent methods is that the anesthetic is toxic, and in some cases, when, for example, uses a significant amount of anesthetic can cause patients side effects such as convulsions. Another disadvantage of tumescent method is that patients may experience an unwanted increase in blood pressure due to the use of epinephrine. Another disadvantage of tumescent method is that it requires significant is the volume of liquid anesthetic along the entire length of Vienna, what makes the procedure endoluminal laser ablation significantly longer, and can lead to unpleasant side effects such as black and blue markings, and other side effects associated with the use of such large amounts of anesthetic.

[00018] Although tumescent anesthesia or tumescent infusion of cold saline solution used in known tumescent method endoluminal laser ablation, create heat around Vienna, you may experience a significantly higher level of thermal damage than it would wish. The stronger temperature damage, the higher the chance of pain after the procedure, the appearance of hematomas and occurrence of paresthesia. For example, a significant amount of tumescent anesthetic used in known procedures endoluminal laser ablation, does not allow the patient to feel the heat stimulation of the nerves and thereby does not give the patient the opportunity to ask the doctor to stop the procedure or change it to prevent unwanted thermal damage. Branches of the tibial nerve and common peroneal nerve may be exposed to such damage. The common peroneal nerve is located close to the surface of the skin on the lateral part of the leg below the knee, and thermal damage of this nerve can lead the tee to foot-drop. Similarly, tibial nerve may be damaged when operating at the upper section of the popliteal fossa. Depending on their degree of thermal damage to the tibial nerve can lead to dysfunction of the muscles of the leg and foot. Sural nerve and saphenous nerve is similarly exposed to the possibility of thermal damage when performing endoluminal laser ablation of the small saphenous vein or great saphenous vein below the knee. Sural nerve passes very close to the small saphenous vein, particularly the distal closer to the ankle. Subcutaneous nerve passes very close to the great saphenous vein below the knee, in particular, again, the distal closer to the ankle. The use of a substantial amount of anesthetic, such as tumescent anesthetic may unwittingly lead to thermal damage to these nerves.

[00019] U.S. Patent No. 6,986,766 refers to the application of marks on the optical fiber to determine the position of the fiber relative to the stiletto-catheter. However, the invention and the invention associated with it, does not contain information to determine the speed of the reverse of removal laser fiber during laser processing. Slow uncontrolled reverse removal laser fiber or catheter may cause overheating and perforation of the vessel wall, as even the best what about the surgeon can cause problems with drainage of the fiber at a certain speed to maintain a suitable temperature of the vessel wall. On the other hand, excessively high speed reverse of removal may cause insufficient for closing the vessel, the amount of energy radiated.

[00020] the Patent application U.S. No. 2004/0199151, Neuberger, the rights to which are transferred to the holder of the present invention, and which is fully incorporated into the present application by reference and is a part of the present disclosure describes a system and method for the controlled release of radiation during subcutaneous treatment with irradiation. A laser connected to the optical fiber, which is injected under the skin or into the vascular cavity to certain places. Then on the processed area is served radiation and the fiber simultaneously assigned to the entry. The fiber is removed manually with a predetermined speed, and radiation exerts its effect at a constant level of power or energy. To maintain the required constant energy density, the speed of retraction is measured and fed to the control mechanism. The control mechanism adjusts the emitted energy, the pulse duration or the pulse rate of to ensure that Vienna or fabric receives a stable dose of energy. Although this solution is much more perfect than the well-known counterparts, the radiation appears flat radiating surface located on the tip of the fiber and n is purposed primarily in the longitudinal direction.

[00021] Accordingly, the present invention is the correction of one or more of the above disadvantages known from the prior art.

Disclosure of inventions

[00022] the Present invention discloses an improved method and apparatus for the safe and effective endoluminal laser ablation, which can be carried out at a relatively low energy density.

[00023] In some embodiments, the execution device for endoluminal treatment of a blood vessel includes a flexible waveguide having an elongated axis, the proximal end of the optical connectivity with the radiation source, and the distal end is made with the possibility of placement in a blood vessel. The distal end includes a radiating surface, the radiant waves from the radiation source laterally with respect to the elongated axis of the waveguide on the outgoing angle of the area surrounding the walls of the vessel.

[00024] In some embodiments, the execution device has an emitting surface (or surfaces), the radiant laser energy radially and substantially around the circumference of the surrounding wall of the blood vessel and any blood, saline, and/or that the fluid located between the wall and the surface. In some embodiments, the execution device generates laser energy continuously or as pulses radially through the fiber essentially conical radiating surface to achieve radial radiation at 360°. Some embodiments of the device further include essentially conical reflecting surface located axially at a distance relative to the conical radiating surface and the unconverted to it, to increase the efficiency of the radial radiation by reflecting the radial or circumferential residual or supplied in the forward direction of energy.

[00025] In some embodiments, performing a few notches, grooves or other means axially located at some distance from each other along the length of the fiber, causing the radiation to partially fed radially outward from the fiber, and partially passed on to subsequent grooves or groove. In some embodiments, performing the energy density is maintained at a relatively low level, preferably about 10 W/cm2or below. In other currently preferred embodiments, the run-emitting fiber span has a length from about 1 cm to about 100 cm in accordance with the length of the treated vein.

[00026] In some embodiments, perform a method for endoluminal treatment of a blood vessel includes the following steps:

(i) the introduction of a waveguide having an elongated axis, into a blood vessel;

(ii) passing radiation through the waveguide and

(iii) the output radiation laterally with respect to the elongated axis Volno the ode on the departing angle plot surrounding the walls of the vessel.

[00027] In some such embodiments, the execution phase of the output radiation contains the output radiation lateral to the area surrounding the vessel wall extending at an angle of at least 90°. In some such embodiments, the execution phase of the output radiation contains the output radiation lateral to the area surrounding the vessel wall extending at an angle of at least 90° to about 360°. Some embodiments of the extras include the phase of the output radiation essentially radially with respect to the elongated axis of the waveguide essentially koltseobrazno the surrounding vessel wall. Some embodiments of the additionally include the step of reflection directed forward radiation essentially laterally with respect to the elongated axis essentially koltseobrazno the surrounding vessel wall. Some embodiments of the additionally include the step of transmitting radiation with a capacity of less than about 10 W at a wavelength in the range from about 980 nm to about 1900 nm.

[00028] In some embodiments, perform a method for endoluminal treatment of a blood vessel includes the following steps:

(i) introduction device for a power supply having an elongated axis, into a blood vessel;

(ii) maintaining an approximately constant size of the blood vessel before and after the introduction of the device to supply energy in crowton the second vessel;

(iii) the flow of energy from the device to supply energy laterally with respect to the elongated axis of the device to the surrounding wall of the blood vessel essentially without changing the shape, flattening, compress or move the walls of the blood vessel toward the feeder and energy

(iv) thermal damage to the blood vessel.

[00029] In some embodiments, perform a method for endoluminal treatment of a blood vessel includes the following steps:

(i) introduction device for a power supply having an elongated axis, into a blood vessel;

(ii) the flow of energy from the device to supply energy to the surrounding wall of the blood vessel essentially without changing the shape, flattening, compress or move the walls of the blood vessel toward the feeder energy;

(iii) essentially filed absorption of energy within the walls of the blood vessel and applying sufficient for clamping a blood vessel damage intravascular endothelium and

(iv) essentially preventing migration of the given energy level capable of causing thermal damage to tissue surrounding a blood vessel, through the wall of the blood vessel in a cloth.

[00030] In some embodiments, perform the method further comprises the step of applying energy in the form of laser irradiation the Oia at least one essentially predetermined wavelength and at least one feed speed energy which leads essentially to the filed absorption of radiation within the walls of the blood vessel in order to cause sufficient damage to the intravascular endothelium and cause a blood vessel to close, and essentially prevents migration of the submitted energy level capable of causing thermal damage to surrounding tissue, through the wall of the blood vessel in the specified fabric.

[00031] In some embodiments, perform a method for endoluminal treatment of a blood vessel includes the following steps:

(i) the introduction of a device for feeding energy into the blood vessel;

(ii) feeding a predetermined amount of energy per unit length of the blood vessel from the device to supply energy to the treated area of the blood vessel, where the specified amount of energy is large enough to close the blood vessel, but low enough essentially to avoid the necessity of introducing anesthetic along the treated area; and

(iii) thermal damage and the closure of a blood vessel.

[00032] In some embodiments, perform a method for endoluminal treatment of varicose veins includes the following steps:

(i) the introduction of a device for feeding energy into the varicose vein;

(ii) feeding a predetermined amount of energy per unit length of vein from the feeder e is ergie the treated area of Vienna, where the specified amount of energy an average of 30 j/cm or below; and

(iii) thermal damage and closure of the vein.

[00033] In some embodiments, the execution unit includes a lid tightly secured to the distal end of the fiber. In some such versions of the distal end of the fiber has a flat radiating surface, and the lid closes the radiating surface. In other versions of the distal end of the fiber contains radially radiating surface, such as a conical surface, and a reflecting surface, and the lid closes as radiant and reflective surfaces. In some versions of the cover is made of quartz or other transmissive material, which is fused, bonded by glue or otherwise permanently attached to the core fiber to protect the core fiber and the emitting surfaces, and migrate through the specified cover the emitted and reflected radiation. In other embodiments of the invention the cover is made of a relatively flexible transparent material, such as polymer Teflon PFA or Teflon AF, to obtain a relatively long, flexible section of the radiation. In the case of relatively low absorbed wavelengths cover may be made of opaque what about the material, to convert all the emitted energy or a part of it into heat. In some embodiments of the invention, the cover and/or fiber includes means for monitoring the temperature within the vein and/or regulation of the input of energy and/or velocity of the reverse acquisition fiber.

[00034] One advantage of these devices and methods is that they can provide a relatively fast, safe, efficient and/or reliable treatment compared with the above-described known methods of treatment.

[00035] Another advantage of the preferred at the moment of the embodiment of the invention is that they can be used to achieve essentially uniform and essentially the same for supplying radiation at relatively low energy densities to the wall of the vein, thereby minimizing the risk of perforation of the vein and, in turn, reducing pain after the procedure compared with conventional methods of treatment.

[00036] Another advantage of some preferred embodiments of the invention is that they can provide safe and effective treatment of venous insufficiency, avoiding the need to use General or local tumescent anesthesia. In some such embodiments perform essentially no anesthetic is necessary along the treated area of the blood is osuda. In other embodiments, there is no need for General or local anesthesia and especially in tumescent anesthesia.

[00037] an Additional advantage of some embodiments of the invention is that they provide a device and method for intravascular treatment by irradiation in multiple, placed at equal distances from each other places, as well as extensive diffuse radiation.

[00038] the above and other objectives, features and advantages of the disclosed inventions here and/or preferred at the moment of its execution will be explained in the following detailed description set forth in conjunction with the attached drawings.

Brief description of drawings

[00039] Figa is a perspective view of the first variant implementation of fiber containing essentially conical radiating surface at the tip of the fiber, essentially conical reflecting surface located axially at a certain distance from the radiating surface facing thereto, and a cover enclosing the emitting and reflective surfaces to achieve an effective radial radiation of laser energy to 360°.

[00040] Fig.1b is a partial side view in vertical section of the optical fiber depicted in figa, and increased in the on its distal section.

[00041] Figa is a partial perspective view of another variant of execution of optical fiber inside a blood vessel.

[00042] Fig.2b is a partial side view in vertical section of the optical fiber depicted in figa.

[00043] Fig.2b is a rear view in vertical section of the optical fiber depicted in figa, where for simplicity the removed portion of the blood vessel.

[00044] Figure 3 represents a schematic illustration of the optical fiber depicted in figure 1 or 2, placed in the treated vein.

[00045] Figure 4 is a schematic diagram of the preferred options for performing device containing a laser light source, an optical fiber, a temperature sensor module power control and drive back exhaust-driven speed controller is reverse of removal.

[00046] Figure 5 is a partial perspective view of another variant of execution of optical fiber containing a protective quartz cover, the core distal end of the fiber with surface grooves, the reflective surface and the guidewire attached to the distal end of the fiber and the distal exhaust from him, and magnified view of the attachment of the wire to the cover.

[00047] Fig.6 is a partial is a perspective view of another embodiment execution of the fiber, containing a fiber optic bundle attached to the distal end of the quartz cover plate wire conductor.

[00048] Figa is a partial perspective view of another embodiment execution of the fiber, where the fiber tip sets reflecting cone.

[00049] Fig.7b is a partial view in cross section of the tip of the optical fiber depicted in figa.

[00050] Figa is a partial perspective view and a transverse section of another variant of execution of optical fiber, including the fiber tip with reflective gap.

[00051] Fig.8b is a view in cross section of the tip of the optical fiber depicted in figa, and enlarged views of part of it.

[00052] Figure 9 is a partial view in cross section of another variant of execution of optical fiber, including an external sleeve, mounted slidable on the fiber and/or the lid, which specifies the internal reflecting surface to prevent migration through laser radiation and control of radiant fiber span.

[00053] Figure 10 is a partial view in cross section of another variant of execution of optical fiber, including essentially flat radiating surface, tightly closed protective transmissive cover.

[00054] f g is a partial view in cross section of another embodiment execution of the fiber, including essentially flat radiating surface, tightly closed protective transmissive sleeve.

A detailed description of the preferred embodiments

[00055] the Preferred at the moment embodiments of the described below with reference to the attached drawings, where similar numerical designations are used to indicate similar elements in different drawings. As described below, preferred at the moment embodiments of the provide for the creation of an improved method and device for safe and effective endoluminal treatment of venous insufficiency with low energy density. Some preferred at the moment options you can also use radially directed, pulsating or constant energy from the fiber. For a circular irradiation is used conical or nearly conical distal end of the fiber opposite the conical reflecting surface mounted on the distal section of the cover. For an extensive radial irradiation can be used multiple, spaced at equal or unequal distances from each other radiating grooves placed longitudinally on the end of the fiber.

[00056] Another property of some currently preferred options the imp is in is the possibility of obtaining large area radiation. This can be achieved by proper placement of the groups opposing cones, through a combination of different variables, i.e. the cut angle of the conical surfaces, the distance between the cones, the refractive index of the cover material and the composition of the gas remaining in the period. Additionally can be used a variety of lenses, such as the many different lenses located axially at a certain distance from each other. Additionally, there may be used a slightly truncated conical tips with appropriate allowances for radiation images formed on the intermediate section. These variables can be adjusted when you change the width of a circular cross-section of the treated vessel, as well as the distribution of energy density along the length of the interval. For example, if necessary, to achieve essentially uniform energy density throughout the cross-section exposed to the radiation.

[00057] In figa and 1b shows the first embodiment of the fiber optic bundle 100. The optical fiber 100 includes a cover 146, the core 140 and a quartz cover 106. The tip of the optical fiber preferably specifies essentially conical radiating surface 110 to achieve radial radiation at 360°. Preferably essentially conical reflecting surface 112 C is ogena axially with respect to the radiating surface 110 and addressed to her, to improve the efficiency and planned distribution plot of the radial radiation. From the drawing it is seen that radiant and reflective surfaces sealed quartz cap 106 which is fixedly mounted on the end of the fiber and restricts air or gas gap on the radiating surface to achieve a radial/circular radiation. Accordingly, due to the angular arrangement of the radiating surface 110 and the difference in refractive indices between the radiating surface 110 and the air or other gas, placed in a sealed cover 106, the laser radiation is emitted radially (i.e. transversely or laterally with respect to the elongated axis of the fiber) and koltseobrazno of the fibers directly onto the surrounding vessel wall. Preferably the radiating surface 110 is located at an acute angle to the elongated axis of the fiber, which allows essentially complete reflection of the emitted radiation laterally with respect to the elongated axis of the fiber. In some embodiments, performing the radiation produced lateral and koltseobrazno the surrounding vessel wall, and annular beam of radiation passes through the arch (i.e. the spread of the beam)a certain numerical aperture of the fiber. In some embodiments, execution of the annular distribution of the beam defined by the angle ranging from about 30° to about 40°. In addition, the approximate center of the beam is preferably oriented at an angle in the range from about 70° to about 90° relative to the elongated axis of the fiber.

[00058] One of the advantages of this new configuration is that essentially all the radiation is carried out radially, and thereby substantially increases the efficiency of radial radiation compared with the above-described known variants. Lateral or radially emitted from the annular beam can be considerably less than the axial or frontal directed conical beam emitted from, for example, a flat fiber bare tip, and thus the lateral radiated beam can more directly and effectively irradiate the vessel wall. In addition, the characteristics of the radiation can be adjusted by changing the length of the annular section of a blood vessel or other processed hollow anatomical structure, as well as the distribution of energy density along the length of such annular area. For example, in another embodiment, megapenny the distal end of the fiber having a linear distribution of grooves arranged axially at a distance from each other, can be used for irradiation of an extensive plot line of the arch of the vein walls, which, in turn, provides an effective treatment for otnositelno low energy density. In a preferred embodiment, the fiber is linearly distributed nagapatnam distal end swinging back and forth or rotated (i.e. approximately one turn) during irradiation in order to achieve radial stimulation of the vein walls 360°. Alternatively, the grooves can be displaced with respect to the fiber, providing essentially all the picture in reverse drain or spin.

[00059] In figa, 2b and 2C shows another embodiment of the optical fiber 200. The optical fiber 200 includes a conventional plot 202, passing along most of the length of the fiber from the proximal end of which is optically connected to the laser source for emitting laser radiation section of the distal end 204. A radiating section 204 contains several evenly spaced grooves, preferably located at a distance of about 1 mm from each other, to achieve radial laser radiation 218 along the radiating area. Each groove 208 causes the portion of the radiation leaving partially radially outward from the fiber 218 and the remaining radiation 216 is partially transferred to the subsequent groove 208.

[00060] the tip of the optical fiber 210 can have an essentially conical shape to achieve radial radiation at 360°, and opposite him is preferably conical reflecting surface 212, to ora, as explained above, increases the efficiency and the radial distribution of radiation at 360° by reflecting any residual or directed forward of the transmitted energy in the radial direction at 360°.

[00061] the Radiating section 204 of the fiber 200 is closed by a protective cover 206. In one preferred embodiment, if the wavelength is well absorbed in the target tissue 214, protective cover 206 is made of quartz or other transmissive or substantially transmissive material (i.e. material that can pass through a radiation or a significant part thereof), such as polymer Teflon AF or Teflon PFA, for relatively long flexible emitting area. In another preferred embodiment, if the wavelength is poorly absorbed in the target tissue 214, protective cover 206 is made from non-transmissive material (i.e. material that absorbs the emitted radiation) in order to convert essentially all or part of the radial radiation into heat to cause thermal damage to the wall of the vein. This is the closure of the veins thermal method instead of direct laser radiation.

[00062] figure 3 shows another embodiment of the optical fiber 320 is placed at a predetermined location in Vienna 314. From Yes the aqueous drawing clear because of the relatively long radiant fiber 320 large plot of veins can be treated at each position (i.e Vienna can be subjected to segmental ablation). The length of the radiating section of the fiber may be any desired length, including, but not limited length in the range from about 1 cm to about 100 cm, in the range from about 1 cm to about 75 cm, or within about 1 cm to about 50 cm In the case where the length of the radiating section coincides with the length of the treated vein area, you can spend a faster and simpler processing, as it may not be necessary in a controlled reverse way. In one such embodiment, the affected part can be processed simultaneously along the entire length, and the fiber can be abstracted when closing the vein walls. In other versions of the grooves spaced out enough (i.e. posted within 1/2 cm to 2 cm, and in one embodiment about 1 cm) and pass along the fiber span of sufficient length for the purpose of processing the whole blood vessel or the desired area at which the fiber is essentially remains in place without the reverse of removal. In other versions of the blood vessel is subjected to segmental ablation by processing the protruding sections sequentially. In od the om such embodiment, the fiber is held in place inside of the first section of the blood vessel, and the laser is activated for processing the first section, then the laser is switched off, and the fiber is pulled back and placed inside the second portion of the vessel, after which the fiber is held in place within the second segment of the blood vessel, and the laser is activated for the processing of the second segment; these steps are repeated for processing any additional sections of the blood vessel, as required by procedure. In other embodiments, performing the laser is not turned off during the reverse of removal or moving from one vein area to another. In other versions of the fiber is held in place when processed by a laser of some sections of the blood vessel, and is given back, while processing other parts of the blood vessel.

[00063] As shown in figure 4, another embodiment of a system for endoluminal laser ablation contains the source 424 laser radiation, the optical fiber 420, the temperature sensor 426, a module 428 for power control and actuator 430 for back-of-way, controlled by the controller 432 speed reverse of removal. During processing module 428 receives a temperature value from the temperature sensor 426, preferably thermocouples, located next to the target tissue. In one embodiment, the temperature sensor is fixed on the fiber or the cover in the immediate Blits and from their radiating/reflecting surfaces. Module 428 processes the data received from the temperature sensor 426, and sends the response as the source 424 and the controller 432. In one embodiment, the module 428 calculates the ideal or desired energy density and the speed of the reverse of removal, and sends this information accordingly the controller 428 laser radiation and the controller 432. The controller 432 controls the actuator 430 for removal of fiber through the blood vessel, and the source 424 sets the laser power in accordance with the control signals received from the module 428. One advantage of these embodiments is that the energy density and/or speed of the reverse acquisition fiber can be adjusted during the procedure endoluminal treatment, for example, in order to ensure closure of the vein, thus essentially preventing the occurrence of localized hot spots, which otherwise could lead to perforation of the vein walls, or essentially preventing overheating of Vienna and/or surrounding tissues, which otherwise would cause the patient unnecessary pain or discomfort. In another embodiment, with manual reverse the dismissal, the module 428 provides physician ideal or desired values of energy density and speed back exhaust, displaying them on the display that allows you to provide more effektivnye reverse bend. The system and/or system components temperature monitoring and control for the reverse of removal, as well as other system variables can be prepared and used in accordance with belonging to the same holder patent application U.S. No.. 11/900,248, filed September 11, 2007, entitled "Device and method for vein treatment", and patent application U.S. No. 11/443,143, filed may 30, 2006, entitled "Energoregulirovaniju medical subcutaneous exposure", each of which is expressly fully incorporated into the present application by reference and is a part of the present disclosure.

[00064] In some currently preferred embodiments, the runtime uses a low energy density, such as about 10 W/cm2or below, but high enough energy density can be submitted to Vienna in a relatively short time to ensure denaturation of collagen, reduction and vein removal. This can be reinforced by using an extended radiating area (or areas), as well as radial irradiation at 360°, so that when the reverse bend sections, initially irradiated proximal side of the radiating section, continue to receive the radiation from the Central and distal sides of the radiating section.

[00065] figure 5 shows another embodiment of the optical fiber 500. The optical fiber 500 sterically plot 502, passing along most of the length of the fiber from the proximal end of which is optically connected to the laser source for emitting laser radiation section 504 of the distal end. A radiating section 504 contains several slots at equal or unequal distance from each other in order to achieve radial laser radiation along the radiating area. The tip 510 of the optical fiber has a standard distal end of the limit angle, but preferably has shown essentially conical shape to achieve radial radiation at 360°, and contains a conical reflecting surface 512 that is located at a distance from the radiating surface and converts it to improve the efficiency of the radial radiation by reflecting any residual or directed forward of the transmitted energy in the radial direction.

[00066] the guidewire 534 attached to the quartz cover 506 using a mechanical system of attachment/removal of the guidewire 536. With the introduction of the medical kit in a blood vessel 514 guidewire 534 remains attached to the optical fiber due to its illustrated configuration. In place of fixing the guidewire 534 has a corresponding form in place 538, so that the system 536 ol the mounting prevents separation when pushing inside, but allows the Department during retraction, thereby ensuring to remove it before the procedure or at the beginning. In another embodiment, the guidewire is attached using acceptable medical adhesive, such as wax ortenaukreis. Expert it is clear that according to the present description of the guidewire can be attached using various methods, including any of various adhesives or other attachment mechanisms known now or in the future. The guidewire may be separated after proper medical kit inside of a blood vessel by means of laser radiation, which softens the adhesive or reduces the degree of binding. After separation of the wire conductor 534 is removed, leaving the closed lid of the optical fiber 500 in the correct position and ready for laser processing. During the processing of the fiber is given by the direction of insertion, compressing the blood vessel 514 and preferably close it.

[00067] In another preferred embodiment, shown in Fig.6, fiber optic kit 600 includes an optical fiber, a quartz cover 606 and guidewire 634. Radial laser radiation is carried out using a variety of surface grooves 608 with reflective surfaces 610, performed at the distal phase the optical core of the fiber. In this case, the guidewire 634 preferably attached to the distal end cap 606. Thus fiber optic kit 600 may be easily inserted and drawn through a blood vessel 614 to the desired location in a single step without requiring removal of the guidewire 634. After reaching the desired location, the physician proceeds to laser processing, allocating fiber kit 600 in the direction of insertion, compressing the blood vessel 614 and preferably close it.

[00068] In figa and 7b shows another embodiment of the optical fiber 700. The optical fiber 700 achieves radial radiation using a reflecting cone 742 placed on the tip of the optical fiber 700. In this embodiment, the reflecting cone 742 defined concave, essentially conical surface. Accordingly, the radiation transmitted through the core of the fiber 740 is emitted radially 360° upon reaching the tip of the fiber. Preferably concave, essentially conical surface of the cone 742 has an acute angle relative to an elongated axis in the range from about 30° to about 50°. As with other forms of execution described above, one advantage of this new concave conical shape is that it achieves effective radial from the doctrine 360° of the surrounding vessel wall.

[00069] In figa and 8b shows another embodiment of a fiber 800. The optical fiber 800 provides radial radiation with the help of having the conical shape of the reflecting gap, is executed at the tip of the fiber. As can be seen from the drawing, the gap 844 convex set, essentially conical radiating surface, is made at the distal end of the core fiber 840, and a concave, essentially conical surface, which is sufficiently transparent for the passage of radiation, and is located axially with respect to the radiating surface at some distance from it, forming in the middle of the gap 844. In this embodiment, the radiation transmitted through the core fiber 840, radially emitted upon reaching the tip of the fiber due to differences in the properties of refraction between the air or other gas within the gap 844 and the core fiber 840. Accordingly, the radiation is emitted radially (i.e. in a lateral direction relative to the elongated axis of the fiber) koltseobrazno or district on the adjacent surrounding wall of the vessel. This configuration with a tip-diffusion provides effective radial radiation of 360°. As can be seen from the drawing, between the outer periphery of the gap 844 and the outer part of the fiber 800 is formed of a relatively thin wall is used for the closure C is Zora inside the tip of the fiber and therefore to maintain the desired transition core-gas in the gap to provide an annular radial laser radiation. As with other forms of execution described herein specified, the new configuration provides an effective radial radiation of the surrounding vessel wall. As can be seen from the drawing, the distal tip of the fiber 800 has an expanded diameter, or localizability plot, which in the illustrated embodiment, the essentially has the shape of a hemisphere to facilitate movement of the tip through the blood vessel. Expert it is clear that according to this description, although localizability plot has the shape of a hemisphere, it can also take many different lukamizeroni and similar shapes and configurations now known or in the future.

[00070] In another embodiment, shown in Fig.9, the lid 906 fiber 900 is partially covered by the sleeve 946, made of reflecting radiation material. As shown by the arrows in figure 9, the sleeve 946 may shift axially with respect to the lid 906 and fiber 900 to control the axial length of the radiating section of the fiber. As can be seen from the drawing, the sleeve 946 can completely cover the desired number of radially radiating grooves 908 or a certain portion of the distal radiating section. Accordingly, one advantage of the implementation depicted in Fig.9, is that it allows the physician to adjust the length of the bat is the future of the site or part of the fiber. In one embodiment, the length of the radiating section is installed in accordance with the length of the vessel 914 or its part under treatment, to perform segmental ablation of such parcel or parcels. In another embodiment, the elongated radiating section is allocated back to Vienna while processing, gradually allowing to process one or more areas to be treated using essentially the entire elongated radiating section. If the vein area is shorter than the length of the radiating fibers, the sleeve can be used to hide the radiating area that is outside of Vienna during irradiation. The sleeve is preferably made of reflective material known in the art of the type capable of performing a specified function. Even when using the perfect mirror surfaces, the reflected light will pass back through the fiber so that some part of the radiation will be collected, some scattered, and another part will be absorbed. Accordingly, a certain amount of energy radiated by the slots covered by a sleeve, is lost as heat. However, as the density of the involved energy is low, any such accumulation of heat can be maintained during treatment endoluminal laser ablation within the minimum acceptable values.

[00071] figure 10 shows more about the ins embodiment of the optical fiber 1100. Fiber 1100 is essentially the same as the optical fiber 100, described above with reference to figa and 1b, respectively, similar numerical designations are preceded by the designation ”11” instead of the symbol ”1”, are used to indicate similar elements. The main difference between the fiber 1100 from the optical fiber 100 is that the tip of the fiber sets essentially flat radiating surface 1110, tightly closed protective cap 1106. Cover 1106 made of sufficiently transparent for the emitted radiation of the material, allowing the radiation to pass through the cover and inside of the vessel wall. In one embodiment, the cover 1106 made of quartz and attached to the core of the fiber by means of adhesive, as described above; however, if necessary, the cover can be made of any material from many different materials and can be fixedly mounted on the distal end of the fiber by any of various methods known now or in the future. As can be seen from the drawing, the protective cover 1106 passes distally relative to the flat radiating surface 1110 fiber and has a distal end 1107, which is rounded to facilitate movement of the closed lid of the fiber winding blood vessel. The distal end 1107 cover 1106 passes distally relative to the planar radiating on the Ergneti 1110 fiber axial distance, which preferably is in the range from about 2 to about 6 diameters of the core fiber, more preferably in the range from about 3 to about 5 diameters of the core fiber. In the illustrated embodiment, the distal end 1107 cover 1106 passes distally relative to the flat radiating surface 1110 of the fiber axial distance, constituting approximately 4 core diameter fiber. As can be seen from the drawing, the protective cover 1106 specifies the internal space 1109 passing between the planar radiating surface 1110 and a distal end 1107 of the cover that allows the transmitted radiation to pass through the space and the wall of the cover, but prevents any contact between the planar radiating surface and the wall of the blood vessel and generally protects the radiating surface of the fiber. Unlike fiber 100 described above, the optical fiber 1100 does not specify essentially conical radiating surface or substantially conical reflecting surface. Thus, the optical fiber 1100 emits essentially conical beam forward or in the axial direction from the fiber.

[00072] figure 11 shows another embodiment of the optical fiber 1200. The optical fiber 1200 is essentially the same optical fiber 1100 described above in connection with figure 10, and accordingly, similar numeric string is achene, preceded by the designation ”12” instead of the symbol ”11”, are used to indicate similar elements. The main difference between the fiber 1200 from fiber 1100 is that the fiber contains 1200 outdoor protective sleeve 1206 instead of a closed protective cover. Protective sleeve 1206 is made of sufficiently transparent for the emitted radiation of the material, allowing the radiation to pass through the sleeve and the inside wall of the vessel. In one embodiment, the protective sleeve 1206 is made of quartz and attached to the core of the fiber by means of adhesive in essentially the same way as the protective cover described above; however, if necessary, a protective sleeve may be made of any material from many different materials and can be fixedly mounted on the distal end of the fiber by any of various methods known now or in the future. As can be seen from the drawing, the protective sleeve 1206 passes distally relative to the flat radiating surface 1210 fiber and defines the distal end 1207, which is rounded or curved inward toward the Central aperture 1209. The distal end 1207 bent inward to facilitate movement of the tip of the fiber through the blood vessel. Protective sleeve 1207 passes distally relative to the flat radiating surface 1210 of the fiber axial distance which preferably is in the range from about 2 to about 6 diameters of the core fiber, more preferably in the range from about 3 to about 5 diameters of the core fiber. In the illustrated embodiment, the protective sleeve 1207 passes distally relative to the flat radiating surface 1210 of the fiber axial distance, constituting approximately 4 core diameter fiber. Unlike fiber 100 described above, the optical fiber 1200 does not specify essentially conical radiating surface or substantially conical reflecting surface. Thus, the optical fiber 1200 emits essentially conical beam forward or in the axial direction from the fiber.

[00073] In some currently preferred embodiments, the optical fiber or other waveguide is first introduced into the treated vein. Optionally, in place of access, you can enter the local layer-by-layer anesthetic, such as a 0.5% solution of lidocaine (preferably without epinephrine). In one embodiment, the access site is put about 1/2 ml of the local anesthetic. Access site introduces a conductive needle, held in Vienna to gain access to the vein. Then, a conductive needle in a vein may be inserted guidewire. Then, stiletto-catheter may be introduced over the wire guide into the vein. Stiletto-catheter may be in the form of any of a variety of different style of the catheter, known now or in the future, including short stiletto-catheter providing access to a relatively short section of Vienna, adjacent to the place of access (for example, having a length of less than about 11 cm, or in the range from about 6 cm to about 11 cm)or more long stiletto-catheter, which may take the entire length of the treated vein. Then the guidewire is removed through the catheter. Then, through the stiletto-catheter optical fiber, up until the emitting tip of the fiber is approximately 1-1/2 inches or other desired distance below the sapheno-femoral joint. The tip of the fiber is located at a suitable starting place below the sapheno-femoral connection using ultrasonic tracking and/or by passing red or other visible beam through the fiber in order to visually monitor the initial position of the tip of the fiber through the skin.

[00074] One advantage of the currently preferred embodiments is that the lid or the other of the distal section of the fiber tip is rounded, thereby facilitating the introduction of its winding through the vein, and eliminating the use of stiletto-catheter and the wire in many, if not all, cases. In preferred versions of the fibers have nesnidal in the range from about 1235 μm to about 1365 μm, caps have an external diameter ranging from about 1800 microns to about 2000 microns, and a rounded distal section of the cover is defined by a radius in the range from about 900 microns to about 1000 microns. Accordingly, although the use of the stiletto-catheter and the wire described above, these steps can be skipped. In another embodiment, if the stiletto-catheter, it can be removed from the vein to the laser processing and return of allotment of fiber. For example, if you have a long stiletto-catheter, stylet-catheter can be retracted and removed from Vienna to the laser processing and return of allotment of fiber. Similarly, if you use a tear-stiletto-catheter, the catheter can be separated and removed from the Vienna to the laser processing and return of allotment of fiber. If you are using a relatively short stiletto-catheter, the catheter can be removed from a vein, or left in place access during the laser processing and the reverse of removal.

[00075] When the tip of the fiber is at the start area directly below the sapheno-femoral connections or other necessary initial section includes the laser emitting the laser energy into the blood vessel. When using radial emitting fiber, laser energy is directed preferably radially and koltseobrazno the surrounding wall of the AOC is analnogo vessel. On the other hand, when using ploskopanelnyh fiber laser energy is emitted in the form of essentially conical, axially directed beam. The emission fiber is allocated back to being at a given speed, based on the wavelength and power used to damage or destroy enough of the plot intravascular endothelium, in order to achieve closure of the vessel. Preferably, the energy per unit length, submitted blood vessel high enough to close the vein, but low enough to essentially avoid the need of anesthesia along the length of the treated vessel. In preferred at the moment versions of the energy per unit length delivered to the treated area of the blood vessel, on average, less than 80 j/cm, preferably less than 50 j/cm, more preferably less than 40 j/cm, more preferably below 30 j/cm, more preferably below 20 j/cm and most preferably less than 10 j/see In some versions of the energy per unit length supplied the processed area of the blood vessel, the average is in the range from about 3 j/cm to about 15 j/cm and preferably is the range of approximately 5 j/cm to about 10 j/see these options, complete and as described below, the wavelength prefer is Ino relatively strongly absorbed by water and is relatively poorly absorbed by hemoglobin or oxyhemoglobin (for example, not less than approximately 1064 nm). One advantage of such specified levels of energy and/or wavelength lies in the fact that (i) the energy can be essentially completely absorbed by the wall of the blood vessel, (ii) intravascular endothelium sufficiently damaged to achieve closure of the vessel, and (iii) the transfer of any significant radiation in the tissue surrounding the blood vessel, essentially prevented, making it possible to avoid the need for anesthesia along the machined portion of the vessel.

[00076] Also, in preferred at the moment embodiments of the invention energy, such as laser radiation, can be served on a permanent basis or in the form of individual pulses. It was found that the flow of energy in the form of individual pulses can be fed on the treated plot on average a higher amount of energy per unit length without the use of anesthetic on the specified arable land compared with supply of laser energy on a permanent basis (i.e., more pulsating energy that can be absorbed by the vessel compared with constant energy, while essentially preventing the transfer of a significant amount of energy through the vessel wall, which could otherwise damage the surrounding tissue). In addition, in General, other factors equal,the higher the percentage of time that when applying pulsating energy cycle is in the "off" state to "enabled", the higher can be the energy per unit length, on average, applied to the treated area of the blood vessel, essentially without requiring the introduction of the anesthetic along the treated area. In some such embodiments, performing more than about 1/2 of the business cycle accounts for the "off" state, and preferably from about 1/2 to about 2/3 of the business cycle accounts for the "off" state. Pulsation can significantly increase the speed of attenuation of radiation in the tissue of the vessel wall compared to constant radiation, thereby leading to a lower depth of penetration at a certain rate of energy supply (e.g., j/cm, the average delivered intravascular device power supply)than in the absence of pulsation (for example, when the continuous emission). Accordingly, one advantage of supplying energy in the form of pulse is that it allows a higher rate of energy supply and therefore may be capable of delivering more power to the intravascular endothelium without the use of anesthetic along the machined portion of the vessel. The term "pulse mode" is used here to refer to any of the possible ways, and is known now or in the future, for the formation of the operating cycle of power supplied to the blood vessel (i.e., recurrent period, during part of which the power supply is active, and the other part, during which the power supply is inactive), such as the cycle of operation of the laser radiation, including, without limitation, pulsing, repetitive switching on and off of the power source, and the interruption of the beam energy, for example by means of a shutter.

[00077] In some preferred at the moment variants of execution, the wavelength is approximately 1470 nm ± about 30 nm. In other preferred embodiments, the execution, the wavelength is about 1950 nm ± about 30 nm. Other variants of the invention uses a wavelength of approximately 810 nm, approximately 940 nm, about 1064 nm, approximately 1320 nm to about 2100 nm to about 3000 nm and about 10,000 nm, each ± about 30 nm. One advantage wavelengths, is much better absorbed by water than by hemoglobin and oxyhemoglobin, is the fact that this wavelength is strongly absorbed by water, but is strongly absorbed by the tissue of the blood vessel. Accordingly, waves these lengths are usually essentially pass through the blood passing between the radiating surface or surfaces of the fiber and the wall of the vessel, and, in turn, are well absorbed article is ncoi vessel. Waves of specified lengths, supplied with a speed below the set speed of the energy supply, essentially completely absorbed by the tissue wall of the blood vessel in order to, in turn, damage or destroy intravascular endothelium at a level sufficient to facilitate closure of the blood vessel depth. Preferably such damage intravascular endothelium are on the average depth of at least about 1/3 the thickness of the intravascular endothelium, or an average in the range from about 1/3 to about 2/3 the thickness of the intravascular endothelium. In the waves of these lengths can more easily absorbed when given a low speed power supply (i.e. on the area treated blood vessel energy on average is served with a speed of less than 50 j/cm, preferably lower than 40 j/cm, more preferably below 30 j/cm, more preferably below 20 j/cm and most preferably less than 10 j/cm), which in spite of this is enough to damage or destruction of intravascular endothelium at a level sufficient to facilitate closure of the blood vessel depth. In addition, since such radiation is essentially completely absorbed by the wall of the blood vessel, essentially prevents heating of the tissue located near or adjacent to the vessel wall, nl is a means by which the procedure can be carried out essentially without the use of anesthetic near the target area of the blood vessel (for example, local detumescent anesthetic can be entered only at the access site, or in only one or a few points at the discretion of the physician or at the request of the individual patient). This wavelength is preferably higher than or equal to about 1064 nm, and including, without limitation, about 1320 nm, about 1470 nm, about 1950 nm to about 2100 nm to about 3000 nm and about 10,000 nm, each ± about 50 nm.

[00078] In some embodiments, performing the wavelength is approximately 1470 nm, ± about 30 nm, the power is less than about 10 W, preferably less than about 8 watts, more preferably less than about 5 watts, and most preferably in the range from about 1 W to about 3 watts. In one embodiment, the laser works on a permanent basis (although the pulse mode can be used if necessary), and the laser is then turned back with a speed ranging from about 1 s/cm to about 20 s/cm, more preferably in the range from about 3 sec/cm to about 15 sec/cm, and most preferably in the range from about 5 sec/cm to 10 s/cm.) In one exemplary embodiment, the large saphenous vein length of about 10 cm was closed when using the essentially radial radiation with a wavelength of approximately 1470 nm, at a power level of about 2 watts, with a speed reverse drain approximately 5 the EC/see In this particular example, the local layer-by-layer anesthetic was introduced only at the access site and was not introduced or otherwise required throughout the rest of the procedure.

[00079] In other exemplary embodiments, execution, several other veins (large subcutaneous) was closed using pascocoacroo fiber, closed quartz cover (see figure 10). Radiation had a wavelength of about 1470 nm, and the energy filed per unit length of the blood vessel averaged about 10 j/cm (i.e. about 1 W at the rate of reverse drain in about 10 s/cm). In each of these cases has not been used for tumescent local or General anesthetic. Instead, it was used by the local layer-by-layer anesthetic (1/2% lidocaine without epinephrine) only on request of the patient or by the physician. In some cases, patients did not enter the anesthetic. In other cases, a small amount of anesthetic was introduced at the access site. In other cases, a small amount of anesthetic was introduced at the access site and near the sapheno-femoral junction. One of the reasons for the introduction of a small number of similar local anesthetic in areas adjacent to the sapheno-femoral junction, was the fact that the diameter of the veins in this area usually the highest, and accordingly, the rate of the reverse drum and also the average energy of a single is Itza length, on average, applied to a blood vessel, in this area can be higher than located on the distal zones of treatment.

[00080] In other exemplary embodiments perform several different varicose veins (large subcutaneous) was closed using pascocoacroo fiber, closed quartz cover (see figure 10). Wavelength filed radiation was about 1470 nm. The primary procedure included the supply of radiation with a speed in the range from about 20 j/cm to about 30 j/cm; however, some patients received energy at a lower feed rate (in the range from about 10 j/cm to about 20 j/cm), and thus filed the energy per unit length was on average within the range from about 10 j/cm to about 30 j/cm (the average was about 22 j/cm). Primary procedure also included the supply of radiation at a power level in about 3 watts in continuous mode; however, some patients received radiation power of about 3 watts in pulsed mode at 50% operating cycle (about 1/2 a second on form and about 1/2 second off). The diameter of the veins ranged from approximately 3 mm to approximately 22 mm (average diameter of the vein was about 8.2 mm). All procedures were performed without any tumescent anesthesia or General anesthesia and without any prior changes Faure is s veins or other of their compression. A few patients received no anesthetic, while others have received a relatively small amount of the local layer-by-layer anesthetic (1/2% lidocaine without epinephrine). Of the 31 patients the average amount used during the whole procedure local anesthetic was about 28 ml, and 7 patients received less than 10 ml is generally considered that the lower the speed of the energy supply, the smaller the amount of anesthetic required or even desirable. In addition, the overall supply of laser energy in a pulsed mode demanded a smaller amount of anesthetic than the flow of energy in continuous mode. In all cases, the anesthetic was administered topically as instructed by the doctor or the patient. Postoperative outcomes after 24 hours showed that over 90% of the treated veins have collapsed, demonstrating excellent performance thickening of the walls of the veins. In addition, postoperative hematoma, and complaining of the pain was almost absent; separate hematoma appeared only about 5-10% of patients, mainly at the access site in Vienna; complaints of postoperative discomfort were minimal, only a small number of patients used pain relievers (such as aspirin, acetaminophen, etc.).

[00081] Accordingly, an important advantage of the preferred at the moment embodiments is that it does not require any local tumescent or General Annes is Asia. As indicated above, in many cases, can be used only a small number of local layer-by-layer anesthesia on the spot access to Vienna, and then if necessary. If during the procedure the patient is experiencing discomfort, your doctor may introduce a small amount of local layer-by-layer anesthetic (eg, lidocaine preferably without epinephrine) in the place or area where you feel uncomfortable. In any case to be not more than 1 mg (about 50 ml) of the local layer-by-layer anesthetic (eg, lidocaine preferably without epinephrine) during the procedure, and only a small part of the specified ampoule may be required depending on the length of the treated vein and/or the sensitivity of the patient to any discomfort, perceived or otherwise manifested.

[00082] Some embodiments of the present invention includes the introduction of a sufficient amount of anesthetic near the femoral nerve to achieve sensory blockade, but not motor blockade hips for anesthesia of the treated area. One such procedure includes the following steps. Finding by means of ultrasound branches of femoral nerve between the sapheno-femoral joint and the femoral artery. The introduction of ultrasound certain amount of local anesthetic (e.g., about 1/2% lidocaine) over the nerve in the area next to the ner the Ohm, but not touching it (outside of a blood vessel or any shell surrounding the treated blood vessel). A certain amount of local anesthetic is enough to cause sensory blockade, but not enough for the emergence of motor blockade. In preferred at the moment versions of the a certain number is in the range from about 10 to about 30 cm3about 1/2% lidocaine and most preferably in the range from about 15 to about 25 cm3about 1/2% lidocaine. The volume of anesthetic may vary depending on the degree of dilution (for example, the concentration of lidocaine in saline solution or another solution). Usually, if the concentration of lidocaine above, the injected volume is lower, and Vice versa. Usually do not need to enter any additional anesthetic during the procedure; however, if necessary, can be applied a small amount of local anesthetic at the site of access, such as a local anesthetic or a few cubic centimeters of a solution of lidocaine. Then the procedure is carried out as described above, for example, a needle is injected into a vein; short stiletto-a catheter is inserted through a needle into a vein; fiber cover is inserted through the stiletto-catheter to the sapheno-femoral joint; turns on the laser and the fiber is given back with a speed in the range from prima is but 20 j/cm to about 30 j/cm, or otherwise, as described here.

[00083] Other embodiments of the present invention include the use of intravenous method or "dropper" for the introduction of the treated blood vessel in order to conduct local anesthesia of the treated area. One such procedure provides the steps, which introduces a small amount of lidocaine on site access for anesthesia of the skin at the access site when necessary (for example, a few cubic centimeters of a solution of lidocaine); access site in the treated blood vessel, the needle is injected; short stiletto-a catheter is inserted through a needle into a blood vessel; covered sleeve fiber is inserted through a short stiletto-catheter, and the tip is covered with a sleeve of fiber is placed in the initial place below the sapheno-femoral joint; covered sleeve fiber may be conventional "liquid cooled" fiber to allow the introduction of fluid between the sleeve and the fiber, and containing one or more output channels, located proximally to the tip of the fiber, which provides dripping or other metered supply of liquid (in this case, dilute anesthetic solution) in a blood vessel located proximal to the tip of the fiber; the instillation of diluted aestheticism solution (e.g. a solution of lidocaine is) in a blood vessel, starting from the sapheno-femoral connection or starting point below the sapheno-femoral joint; after the beginning of action of lidocaine, turns on the laser and the fiber is allocated back to the desired speed (e.g., from about 20 j/cm to about 30 j/cm or different, as described herein); the output channels for dilute anesthetic is located proximally with respect to the tip of the fiber, and thus the anesthetic is applied to the areas of the blood vessel immediately before the laser treatment, making processed by the laser portion of the vessel anesteziruta before processing.

[00084] Other embodiments of the present invention include local anesthesia of the area being treated through the introduction of local detumescence anesthetic before the introduction of fiber into the blood vessel. In some such embodiments, run a small amount of dilute anesthetic (1% lidocaine) is injected at the place of access on the mid-point of the blood vessel (for example, "Hunters Crossing or near it) and sapheno-femoral joint or beside him and the number entered in each point of the local anesthetic is not more than about 3-5 ml, and the total quantity entered does not exceed approximately 9-15 ml

[00085] In other embodiments perform any of a variety of other ways Le is to be placed, known now or in the future, can be used to relax the patient and/or analgesia, anesthesia, and/or reducing sensitivity to painful stimuli. Such methods include without limitation electroanalgesia, electroanesthesia, neurostimulation, neuromodulation and other physical or verbal methods of analgesia, anesthesia and/or reducing sensitivity to painful stimuli. Other similar methods include anesthesia electric current on the basis of, for example, percutaneous or subcutaneous nerve stimulation, deeper stimulation, stimulation of the posterior part of the spinal cord, and transcutaneous electrical brain stimulation. The present description of anesthetics and analgesics does not imply that any anesthetics or analgesics required in connection with the disclosed devices and methods for endoluminal treatment. Many preferred embodiments of the do not imply the use of any anesthetic or analgesic or at best use a small amount of local anesthetic or analgesic access site or other place in which you must stop any localized pain, apparent or otherwise apparent to the patient.

[00086] Accordingly, an important advantage of devices and procedures disclosed here, h is about with their help it is possible to avoid the above described disadvantages, associated with tumescent method, including potential toxicity and/or adverse reactions in patients associated with such anesthetics, more frequent cases of thermal damage to the surrounding tissue, and post-operative pain and bruising that occur when using high levels of energy used in the procedures tumescent method. Another advantage of the preferred at the moment embodiments above known procedures tumescent method is that a blood vessel retains almost the same size before and after introducing the device to power, and power is supplied to the surrounding wall of the blood vessel without prior changes in the shape, flattening, compress or move the walls of the blood vessel toward the feeder energy.

[00087] As described above, cover or other structure on sluchayem the end of the fiber creates a rounded, having essentially a relatively large diameter, the distal section of the tip of the fiber, thereby facilitating the introduction and the reverse bend in Vienna. Another advantage of this extended structure of the tip of the fiber as compared with the known from the prior art fibers with bare tip is that the tip displaces a greater volume or area Palast the veins. Another advantage of certain preferred at the moment embodiments is that the laser radiation is fed radially and koltseobrazno from the fiber to the surrounding annular portion of the wall of the vein, thereby more directly and effectively transferring the radiation in the wall of the vein, in comparison with the known methods and devices for endoluminal laser ablation. Another advantage of certain preferred at the moment embodiments is that the tip of the optical fiber may have a significantly larger area of the radiating surface in comparison with the known uncovered tips or other fibers with a flat radiating surface, and in addition, radiation is served lateral/radial. As a result, the laser light is transferred directly to a significantly greater area surrounding tissue of the vein walls, and can be made at much lower energy density compared with known procedures endoluminal laser ablation order thereby to facilitate the treatment without the formation of hot spots that could cause perforation of the walls of Vienna, overheating the surrounding tissue and the associated pain and discomfort experienced by the patient. Accordingly, another advantage of the preferred is sustained fashion at the moment embodiments, they can use a much lower power level in comparison with the known procedures endoluminal laser ablation.

[00088] Another advantage of some preferred at the moment embodiments is that the used laser wavelength is well absorbed by water and therefore are well absorbed by the tissue wall of the blood vessel. As a result, the laser light directly enters the surrounding annular wall section of the vessel and absorbed them in sufficient depth intravascular endothelium destruction or damage absorbing endothelium and, in turn, provides the closure of the blood vessel. The terms "closure of a blood vessel", "close the blood vessel, clamping the blood vessel" and similar terms are used here to denote the closure or compression of a blood vessel, sufficient basically to prevent blood flow at the specified blood vessel after it is processed. Another advantage of certain preferred at the moment embodiments is that due to the fact that the laser radiation directly and effectively served on the vessel wall and is absorbed, it is essentially possible to avoid significant absorption of radiation surrounding tissues and subsequent tempera is to become damage. As a result, preferable at the moment, ways to perform not only require less energy than known procedures endoluminal laser ablation, but also require less anesthetic, or does not require, and allow to use local tumescent anesthesia, which is associated with many disadvantages and problems.

[00089] When the need for cooling and/or numbness in the vein before treatment and reverse tap fiber, you can use the washing with saline solution, for example, washing with cold saline. In some such embodiments, the execution is very cold saline solution (for example, from about 30°F (-1°C) to about 40°F (4°C), more preferably from about 32°F (0°C) to about 35°F (2°C) to accelerate numbness veins before treatment. In one embodiment, the cold saline solution is supplied into the vein using a stiletto-catheter prior to the introduction of fiber. In another embodiment, the cold saline solution is supplied into the vein using a stiletto-catheter after insertion of the fiber and/or during removal stiletto-catheter before the laser treatment. In yet another embodiment, the cold saline solution is supplied into the vein using a sleeve surrounding the fiber during laser processing and return of allotment of fiber. In the latter embodiment, the cold saline under the is through one or more output channels, located next to the emitting tip of the fiber (for example, at the base of the quartz cover). One such embodiment of uses conventional chilled fluid sleeve fiber.

[00090] In some embodiments perform to the fiber or other waveguide is fed ultrasonic energy to ensure a smooth reverse drain on Vienna or reverse venting essentially constant or other desired speed. In one embodiment, the ultrasonic transducer connected to the proximal end of the fiber, imparting ultrasonic vibration to the radiating tip or area of the fiber during laser processing and back-of-way. In another embodiment, the ultrasonic transducer or vibrator attached to the cover or otherwise attached to the radiating tip or fiber span, telling him ultrasonic vibration during laser processing and return of allotment in Vienna.

[00091] In some embodiments, the performance of the present invention, the fiber is a medical fiber ftorpolimernoj a lid or other device to apply laser or light energy fiber-based with ftorpolimernoj radiating surface. One advantage ftorpolimernoj radiating surface is that it does not stick to the wall of a blood vessel or turn the-standing blood vessel, and thus it may be easier to take back the blood vessel than other devices.

[00092] in Another preferred embodiment, the fiber optic bundle is equipped with three or more sliding handles with shape memory effect. With the introduction of the medical kit sliding handle constantly in contact with the protective coating. Upon reaching the appropriate position of the sliding handles are activated by the internal/external source of energy, pushing their distal ends until, until you come into contact with the inner surface of the blood vessel. As a consequence, the fiber optic bundle is essentially located in the center of the target tissue, additionally facilitating essentially uniform heating of the inner surface and additionally preventing contact with the wall of the vein or perforation. Essentially evenly heated surface should, in turn, shrink more evenly and effectively compress the blood vessel to achieve complete closure where necessary.

[00093] In preferred at the moment versions of the wavelengths selected to provide a sufficiently high level of absorption in the target tissue, for example, about 1470 nm ± about 30 nm and/or about 1950 nm ± about 30 nm. As will be clear to the expert, these wavelengths are the I only example and any of the numerous other wavelengths, known now or in the future, can be used in equal measure, including, but not limited length of about 810 nm, 940 nm, 980 nm, 1064 nm, 1320 nm, 2100 nm, 3000 nm and 10,000 nm, each ± about 30 nm. One advantage of the wavelengths in 1470 nm and 1950 nm is that they are well absorbed by water and therefore are well absorbed by the target tissue wall of the blood vessel. The absorption wave length at 1470 nm and 1950 nm tissue wall of the blood vessel approximately 1-3 orders of magnitude higher than for waves with a length of 980 nm, and still significantly higher than for most other used wavelengths.

[00094] transmissive Protective cover according to a preferred at the moment variants of execution of the invention can be manufactured and attached to the fiber in accordance with belonging to the same holder patent application U.S. No. 11/592,598, filed November 3, 2006, entitled "Optical fiber made with the possibility of lateral radiation, for use in the devices of great power", which is fully incorporated into the present application by reference and is a part of the present disclosure. Fiber and other components of the device can be identical or similar to the devices, components and their various aspects are described in belonging to the same holder provisional patent application U.S. No. 6/067,537, filed on February 28, 2008 under number Express mail EB429577158US, entitled "Device for quick insertion and improved method of laser treatment of blood vessels", which is fully incorporated into the present application by reference and is a part of the present disclosure.

[00095] As described above, in some preferred versions of the closing wall of the blood vessel is achieved by thermal damage or destruction on average at least 1/3 of the thickness of the intravascular endothelium, or by thermal damage or destruction of the thickness of the intravascular endothelium on average in the range from about 1/3 to about 2/3 of its thickness. As also indicated above, wavelengths, is well absorbed by water and served with a given speed of delivery of energy, essentially completely absorbed at a depth of at least about 1/3 or in the range from about 1/3 to about 2/3 of the thickness of the intravascular endothelium order, in turn, prevent the transfer of a significant level of radiation on the surrounding tissue and thereby avoid the necessity of applying anesthetic along the treated vessel. Intravascular endothelium can be damaged in order to facilitate the closing of a blood vessel using mechanisms other than radiation. For example, U.S. patent No. 6,402,745, ('745 patent") discloses nutrion the first electrode-whip for ablation of veins, fully incorporated into the present application by reference and is a part of the present disclosure. Some embodiments of 745 patent does not deliver electrical energy to the intravascular endothelium, and other embodiments of the deliver. In accordance with one implementation of the present invention intravenous device comprises a rotating whip or other device for Stripping or galling of intravascular endothelium, as disclosed, for example, in the patent 745, as well as primary intravascular device for a power supply that supplies enough energy intravascular endothelium, which together with snagging or abrasion by means of a switch or other device sufficient damage at least about 1/3 to about 2/3 the depth of the endothelium with the aim of closing the blood vessel. In some such versions of the device to power an optical waveguide, which delivers radiation with a wavelength of, well which people absorb guided in water (i.e. about 1064 nm or higher). In some such versions of the radiation is supplied by a pulsed way that allows you to provide a relatively high feed rate of energy essentially without the use of any anesthetic along the treated area or areas of the blood sucking is and. The snagging or abrasion by means of a switch or similar device can provide even more low speed supply energy to the wall of the blood vessel, allowing sufficient damage to the vessel that it was closed, and not to use any anesthetic along the treated area or areas of the vessel.

[00096] the Above-described various preferred embodiments of the present invention with reference to the attached drawings, but it should be understood that the invention is not limited to these specific choices of execution, and that various changes and modifications can be made by experts if these changes are not beyond the scope of the present invention defined in the attached claims. For example, radiation can be delivered in a pulsed or continuous mode and may contain waves of one or more lengths. Additionally, radiation can be delivered by devices other than lasers, including but not limited to LEDs and sverhdominanta LEDs. Additionally, the fiber may be any of many different types of fiber or waveguides, known now or in the future, which may have any of a variety of different cores, coatings, covers, end caps, protective sleeves, reflective surfaces the TEI and/or different lenses, known now or in the future. For example, although many of the fibers described herein are covered, can be used and fiber without covers, including fiber with uncoated tips. Further, the radiating surfaces may take any of numerous different shapes and configurations now known or in the future. For example, although specific embodiments of the use emitting surface being conical in shape, with equal success can be used and the radiating surfaces having different arcuate surface contours (i.e. curved surface contours), or having neuroablative surface contours, such as flat and/or angular emitting surface. Additionally, methods of treating veins may use any of a variety of different devices with the use of anesthesia or without, including, but not limited device sleeveless or catheters, or any of the many different types of sleeves or catheters, including, without limitation, short, long and/or tear-stiletto-catheters without wire conductors or with them, including but not limited to wire conductors attached, separable or not attached to the fiber or waveguide. In addition, can be equally used any form of many forms of energy and devices on the I power supply, known now or in the future, for the treatment of blood vessels with various aspects of the inventions disclosed here. For example, a device for supplying energy can take the form of (i) a waveguide or optical fiber transmitting laser energy as described above; (ii) microwave catheter or device, the radiating microwave energy; (iii) high-frequency catheter or device emitting high-frequency energy; (iv) electrical catheter or device, emitting electricity; and (v) ultrasonic catheter or device, emitting ultrasonic energy. Accordingly, the present detailed description of the preferred at the moment embodiments of the invention shall be interpreted as illustrative example, not limited to the described options.

1. Device for endoluminal treatment of a blood vessel, comprising:
a flexible waveguide having an elongated axis, a proximal end, optical connectivity with the radiation source, the distal end is made with the possibility of placement in a blood vessel and containing at least one emitting surface emitting radiation from the radiation source in a direction with respect to the elongated axis of the waveguide by passing in the angular range of the area surrounding the walls of the vessel and the lid, which is rigidly p is trapline to the waveguide, tight against him, essentially transparent to the emitted radiation, covers the specified at least one emitting surface and forms the boundary of the gas and of the waveguide, which refracts the emitted radiation in a direction with respect to the elongated axis of the waveguide of the surrounding vessel wall.

2. The device according to claim 1, wherein the specified at least one emitting surface is in the angular range relative to the elongated axis of the waveguide.

3. The device according to claim 2, in which indicated at least one emitting surface forms a curved surface contour and is held in an angular range of at least from about 90° to about 360°.

4. The device according to claim 2, in which indicated at least one emitting surface has an essentially conical shape and is essentially convex or concave.

5. The device according to claim 1, additionally containing a reflecting surface spaced from the said at least one emitting surface in the distal direction and converts it to reflect the forward directional radiation in the direction relative to the elongated axis of the waveguide.

6. The device according to claim 5, in which the reflective surface forms a curved surface contour, oriented at an acute angle relative to an elongated axis in which Levada.

7. The device according to claim 6, in which the reflective surface has an essentially conical shape and is essentially convex or concave.

8. Device according to any one of claims 1 to 7, optionally containing a reflecting surface to reflect radiation that is located in the cover, spaced from the said at least one emitting surface and converts it to reflect the forward directional radiation in the direction relative to the elongated axis of the waveguide.

9. The device according to claim 1, wherein the specified at least one emitting surface includes a first emitting surface, is made at the distal end of the waveguide, and the second emitting surface located in the proximal direction relative to the first emitting surface and spaced from each other in the axial direction, and the first and second emitting surface emitting form the distal section, emitting radiation in the side.

10. The device according to claim 9, in which the first emitting surface has an essentially conical shape, each of the second emitting surface forms a curved surface contour, passing in the angular range with respect to the elongated axis of the waveguide and emits part of the radiation transmitted through the waveguide in a direction with respect to the elongated axis of the surrounding curved Uch is the discharge vessel, and allows the rest of the passed rays pass through the waveguide and emitted in the direction of any of the second emitting surface located further in the distal direction, and the first emitting surface.

11. The device according to claim 9, further containing a cover, which is held in the axial direction, covers the specified emitting distal section forms a gas boundary on each of the first and second emitting surfaces, sealed towards the outside of the waveguide is essentially transparent to the emitted radiation, is flexible enough to provide bending of the waveguide passing through the tortuous blood vessel, and interacts with the specified curved surface contour, passing in the angular range of at least first and second spustitelnych surfaces for the refraction of radiation in the direction relative to the elongated axis of the waveguide.

12. The device according to claim 9, further containing a sleeve mounted on the waveguide can move and forming an internal reflecting surface to reflect the radiation emitted in the direction of inside and control the axial length of the specified emitting distal section.

13. The device according to claim 1, additionally containing a radiation source, a temperature sensor thermally connect the i.i.d. with distal section of the waveguide for monitoring temperature in a blood vessel and transmitting signals, the appropriate temperature, and a control module, electrically connected to the temperature sensor for regulating the output power of the radiation source based on the specified module.

14. The device according to item 13, additionally containing a lateral actuator, connected to a waveguide capable of transmitting drive force to control the speed of retraction of the waveguide, and a control module electrically connected to the discharge drive to regulate the speed of withdrawal of the waveguide depending on the temperature of the distal section of the waveguide.

15. The device according to claim 1, additionally containing a guidewire coupled to the waveguide with the ability to detach or rigidly mounted thereon and including a distal section extending in the distal direction from the distal end of the waveguide for conducting waveguide through the blood vessel.

16. The device according to claim 1, wherein the waveguide is an optical fiber.

17. The device according to claim 1, additionally containing at least one laser source generating laser radiation at least at a wavelength of about 1470 nm, or about 1950 nm ± about 30 nm, with a capacity of not more than 10 W, and the proximal end of the optical waveguide is connected with the specified at least one laser source, and the said at least on the on the emitting surface of the waveguide emits radiation in the direction with respect to the elongated axis of the waveguide of the surrounding vessel wall in the form of a ring-shaped spots, passing along the axis.

18. The device according to 17, further containing an electric discharge device that is connected to a waveguide capable of transmitting drive force and configured to exhaust the waveguide through the blood vessel by applying laser radiation with an average speed of supply of energy to the vessel wall less than about 30 j/see

19. Device for endoluminal treatment of a blood vessel, comprising: a flexible waveguide having an elongated axis, a proximal end, optical connectivity with the radiation source, the distal end is made with the possibility of placement in a blood vessel, and comprising emitting means for emitting radiation from the radiation source in a direction with respect to the elongated axis of the waveguide by passing in the angular range of the area surrounding the vessel wall, and covering means to cover the emitting means and the formation of the gas boundary for the refraction of the emitted radiation in the direction relative to the elongated axis of the waveguide.

20. The device according to claim 19, further containing a reflecting means for reflecting forward directional radiation in the direction relative to the elongated axis of the waveguide.

21. The device according to claim 19, additionally containing diffuse emitting means for emitting diffuse radiation in a hundred the ONU relative to the elongated axis of the waveguide over a portion of the waveguide, passing along the axis.

22. The device according to item 21, further containing a regulating means for regulating the length of the diffuse emitting means.

23. Method for endoluminal treatment of a blood vessel, including:
(i) the introduction of a waveguide having an elongated axis, into a blood vessel;
(ii) the transfer of radiation through the waveguide;
(iii) the radiation emitted in the direction relative to the elongated axis of the waveguide by passing in the angular range of the area surrounding the vessel wall, and the emission of radiation, including the radiation emitted simultaneously in the direction of the plot surrounding the walls of the vessel, passing in the angular range of approximately 360°.



 

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SUBSTANCE: method involves the exposure to a travelling magnetic field generated by AMO-ATOS apparatus and sessions of a colour-pulse therapy. The exposure to the travelling magnetic field is characterised by density 42 mT, frequency 10 Hz and length 15 minutes. The exposure covers the intestine. The therapeutic course is 8-10 daily procedures. The sessions of the colour-pulse therapy represent the alternating exposure on the left and right eyes. The exposure represents green stimuli. The exposure length is specified individually taking into account a type of the nervous system within 2 to 10 seconds.

EFFECT: prolonged remission, improved psychoemotional state in the child.

5 tbl, 2 ex

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2 tbl, 2 ex

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1 ex

FIELD: medicine.

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1 ex, 1 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to - physiotherapy, to infectious diseases. The method involves the integrated use of drug preparations, magnetic and laser therapy. The laser therapy is differentiated depending on the severity, modified leukocytal intoxication index (mLII), malondialdehyde (MDA), lipid hydroperoxide (LHP), antioxidant activity (AOA), interleukin-1β (IL-1β), tumour necrosis factor (TNF-α). The mild severity, mLII within the range of 2.8±0.09-3.44±0.07, MDA 3.7±0.08-4.2±0.07mcm/ml, LHP 10.1±0.1-11.3±0.09 mcm/ml, AOA 0.489±0.005-0.390±0.007, IL-1β 25.3±0.5-26.71±0.3 pg/ml; TNF-α 37.1±0.5-45.7±0.8 pg/ml require the daily percutaneous exposure to a constant magnetic field and low-intensity laser light of power 55 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours. The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 60 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power min. 5 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by a light guide tip. The length of the exposure is 120 minutes. The therapeutic course consists of 5 procedures. The moderate severity, mLII 4.18±0.08-6.06±0.07, MDA 4.9±0.03-5.6±0.02 mcm/ml, LHP 12.3±0.08-14.7±0.07 mcm/ml; AOA 0.345±0.007-0.315±0.006, IL-1β 27.1±0.2-28.1±0.1 pg/ml, TNF-α 57.7±0.9-72.1±0.5 pg/ml requires the daily percutaneous exposure to the constant magnetic field and low-intensity laser light of power 60 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours. The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 90 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power 7 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by the light guide tip. The length of the exposure is 150 minutes. The therapeutic course is 7 procedures. The severe condition, mLII 7.76±0.08-8.06±0.07, MDA 7.1±0.03-11.6±0.02 mcm/ml, LHP 16.3±0.08-19.7±0.07 mcm/ml; AOA 0.310±0.007-0.294±0.006, IL-1β 30.1±0.2-31.1±0.1 pg/ml, TNF-α 76.7±0.9-85.1±0.5 pg/ml requires the daily percutaneous exposure to the constant magnetic field and low-intensity laser light of power 60 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 120 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power 9 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by the light guide tip. The length of the exposure makes 180 seconds. The therapeutic course consists of 9 procedures. For the first five days, all the patients are prescribed with heparin electrophoresis by common technique during afternoon.

EFFECT: method reduces a rate of recurrence.

3 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to - physiotherapy, to infectious diseases. The method involves the integrated use of drug preparations, magnetic and laser therapy. The laser therapy is differentiated depending on the severity, modified leukocytal intoxication index (mLII), malondialdehyde (MDA), lipid hydroperoxide (LHP), antioxidant activity (AOA), interleukin-1β (IL-1β), tumour necrosis factor (TNF-α). The mild severity, mLII within the range of 2.8±0.09-3.44±0.07, MDA 3.7±0.08-4.2±0.07mcm/ml, LHP 10.1±0.1-11.3±0.09 mcm/ml, AOA 0.489±0.005-0.390±0.007, IL-1β 25.3±0.5-26.71±0.3 pg/ml; TNF-α 37.1±0.5-45.7±0.8 pg/ml require the daily percutaneous exposure to a constant magnetic field and low-intensity laser light of power 55 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours. The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 60 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power min. 5 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by a light guide tip. The length of the exposure is 120 minutes. The therapeutic course consists of 5 procedures. The moderate severity, mLII 4.18±0.08-6.06±0.07, MDA 4.9±0.03-5.6±0.02 mcm/ml, LHP 12.3±0.08-14.7±0.07 mcm/ml; AOA 0.345±0.007-0.315±0.006, IL-1β 27.1±0.2-28.1±0.1 pg/ml, TNF-α 57.7±0.9-72.1±0.5 pg/ml requires the daily percutaneous exposure to the constant magnetic field and low-intensity laser light of power 60 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours. The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 90 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power 7 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by the light guide tip. The length of the exposure is 150 minutes. The therapeutic course is 7 procedures. The severe condition, mLII 7.76±0.08-8.06±0.07, MDA 7.1±0.03-11.6±0.02 mcm/ml, LHP 16.3±0.08-19.7±0.07 mcm/ml; AOA 0.310±0.007-0.294±0.006, IL-1β 30.1±0.2-31.1±0.1 pg/ml, TNF-α 76.7±0.9-85.1±0.5 pg/ml requires the daily percutaneous exposure to the constant magnetic field and low-intensity laser light of power 60 mWt, wave length 0.89 mcm, pulse frequency 80 Hz in the morning hours The contact scanning exposure covers a projection of thymus, regional lymphatic nodes and great vascular pedicle. The length of the exposure makes 120 seconds per each region. Then, an inflammatory centre is exposed to pulse red light of wave length 0.65 mcm, output pulse power 9 Wt, pulse frequency 80 Hz, modulation frequency of light-emitting diodes 8 Hz generated by the light guide tip. The length of the exposure makes 180 seconds. The therapeutic course consists of 9 procedures. For the first five days, all the patients are prescribed with heparin electrophoresis by common technique during afternoon.

EFFECT: method reduces a rate of recurrence.

3 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to - arthrology, physiotherapy, balneology. The method involves physical methods of therapy, therapeutic exercises, massage, acupuncture and phytotherapy. The patients are trained to give a self-massage of the knee joints additionally during the resort therapy and after the termination of the rehabilitation. From the 1st to 10th day of the therapeutic course patient's knee joint is exposed to polychromatic polarised light at 20 cm for 6 minutes. The patients take 10 iodine-bromine baths at temperature 37°C for 10 minutes. From the 1st to 5th therapeutic days, the patients do combined therapeutic exercises; their lower extremities are massaged manually for 10 minutes. From the 6th to 15th days, the knee joints are exposed to sinusoid modulated currents (SMC) at modulation frequency 100 Hz, at a depth of 50 - 70%, current intensity to moderate vibration for 7 minutes. From the 6th to 10th days, the braking acupuncture follows by giving a 1-2-minute massage of the points 10RP, 9RP, 36E, 34E by introducing a needle for 30 seconds and by giving a point massage of cheng-fu, cuan, yang-lin-cuan, zu-sang-li, wei-yang, cheng-shan, chung-feng, hun-lun, nei-ting. The patients take a herbal infusion. From the 11th to 15th days, the knee joints are exposed to decimetric waves (DMW). That is followed by a hydro-massage of the lower extremities and lumbar region for 15 minutes up to 3 atm. Thereafter, the 10-minute post-isometric relaxation of the quadriceps muscle of thigh is applied. The patients do the complex of weight reduction exercises and take the herbal infusion. From the 16th to 20th day, the mud applications on the knee joints are prescribed at temperature 42°C for 30 minutes. If suffering gonarthrosis, the patients do the complex of therapeutic exercises. That is followed by the paravertebral vacuum therapy of the vertebral column. The 10-minute knee joint traction is applied. The patients take 20 g of the herbal infusion.

EFFECT: method recovers the joint mobility, improves the exercise tolerance of the lower extremities.

1 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to mammology and can be applied in treatment of fibrocystic breast disease. Under ultrasonographic control cyst cavity is punctured, its content is evacuated until cyst cavity is completely emptied and its walls collapse. Light guide is introduced into remaining cavity of cyst through opening of puncture needle and impact with laser radiation with wavelength 805 or 970 nm, power 0.5-1.0 W is performed in pulse-periodic mode with pulse/pause duration 0.1-0.05 sec with rate of light guide movement 1.0-1.5 mm/sec.

EFFECT: method makes it possible to reduce trauma of treatment, eliminate recurrences of cyst formation and reduce healing time due to maximally sparing and efficient modes of laser impact.

3 ex

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment and aims at real-time optic pyrometer-based tissue temperature monitoring. A catheter comprises a catheter body, a distal section of a tip which includes an ablation electrode accommodating a shell and a stopper forming a cavity, and an optical fibre passing through a cavity a distal end of which is placed in a hole of the ablation electrode shell. An optic fibre provides detection of black body radiation during ablation tissue removal. The catheter is a part of systems for the detection of black-body radiation during ablation tissue removal, and for ablation removal and tissue temperature measurement. The catheter for ablation cardiac tissue removal also comprises a deflectable portion distal to the catheter body, a tip section with the electrode for RF ablation cardiac tissue removal, and an optic collector for the detection of black body radiation from cardiac tissue. This catheter is a part of the system for cardiac tissue removal and tissue temperature measurement which also contains the system of the detection of optic emission coupled with the optic collector for processing signals representing the wavelength of at least a part of black-body radiation to determine tissue temperature.

EFFECT: use of the invention enables real-time tissue temperature monitoring during the injury removal procedure to avoid the critical temperature threshold.

18 cl, 12 dwg

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely, to spectroscopic method of defining in real time ablation speed in cardiac tissue in-vivo. For this purpose probe irradiation with wavelengths of near-wave infrared range (NIR) are directed at cardiac tissue in-vivo in such a way, that probe irradiation interacts with cardiac tissue to form spectrum of reverse dispersed irradiation. Spectrum contains intensity dependence on wavelength on said wavelength range. Then ablation irradiation is directed at cardiac tissue. Inclination of said spectrum is measured. Stage of ablation irradiation direction is carried out simultaneously with stage of inclination measurement. Speed of tissue ablation is determined, proceeding from said slope.

EFFECT: application of invention makes it possible to extend arsenal of technical means, which make it possible in real time to determine in real time ablation speed by spectroscopy method.

20 cl, 5 dwg

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical equipment, namely, to laser probes and their combinations, applied in ophthalmology. Probe contains irradiating optic fibre for light beam irradiation, optic system, located on the irradiation side of irradiating optic fibre, and two or more receiving optic fibres, located opposite to irradiating optic fibre. Optic system contains diffractive surface. Light beam, irradiated by irradiating optic fibre, is diffracted into two or more diffracted light beams, focused in plane, parallel to diffraction surface. Receiving ends of each of two or more receiving optic fibres, are intended for reception of light beam, diffracted by optic system, are located in plane, parallel to diffraction surface. Another version of implementation is ophthalmologic laser probe, containing irradiating optic fibre and optic system, located on irradiation side of irradiating optic fibre. Optic system is made in the same way as in the previous version. Connection for laser probe contains case, optic system, located in case, first connecting link, located on one side of optic system; and second connecting link, located on the other side of optic system. Optic system contains diffraction surface, each of two or more diffracted light beams is focused in plane, parallel to said surface.

EFFECT: application of group of inventions will make it possible to reduce operation time due to probe construction which makes it possible to form multipoint laser beam.

27 cl, 16 dwg

FIELD: medicine.

SUBSTANCE: invention refers to laser medicine. Aspiration of the cyst content is carried out and it is induced with diode laser at ultrasound control. After aspiration photosensitiser of chlorin series, with only half the amount of aspirated content with exposure for 2 hours is injected to the cyst cavity. Then the remnants of a photosensitiser are aspirated and an influence on the cyst wall with laser light with a wavelength of 1264 nm with pulse width 0.1-0.5 seconds at radiated power of 0.8-2 W is carried out up to formation of ultrasound image of inflammatory rim around the cyst walls. The method enables to prevent possible tumor proliferation of cells forming the walls and the contents of the cyst cavity, strong bonding of cyst cavity walls throughout their length.

EFFECT: development of an effective method of treatment thyroid cysts.

3 cl, 1 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to experimental surgery. It involves ultrasound aided transcutaneous puncture above a focal mass with using a needle with a mandrin. The latter is removed when reaching an edge of a parenchymal organ. Through a needle lumen, a laser guide is passed to a distal edge of the needle. The parenchyma is exposed at wave length 1064 nm and power 10 Wt in a constant mode, with advancing the needle through the parenchyma to borders of the focal mass. The light guide is removed, and the focal mass is punctured.

EFFECT: method provides elimination of haemorrhage and bile flow from a puncture canal, minimally invasive manipulations.

1 ex, 1 dwg

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to low-invasive surgery, traumatology and orthopedics. Method includes carrying out closed reposition of bone fractures of long tubular bone. Into intramedullary canal introduced is intramedullary rod of definite length with longitudinal canal, which crosses lower-located and higher-located holes on its working end. By pulse laser intraosteal burning in tubular bone formed are holes coinciding with lower-located and higher-located holes on working end of intramedullary rod. After that through holes formed in tubular bone blocking screws are introduced. Measuring laser signal at wavelength λ1 and operating laser signal at wavelength λ2 are delivered to place of formation of holes in tubular bone by means of preliminarily introduced into longitudinal hole of intramedullary rod light guide, whose distal end is mechanically joined and optically connected to acousto-optic tip and whose inlet aperture is mechanically joined and optically connected to optic outlet of double-frequency transmitting-receiving optic unit. Alternate mechanic and optic co-adjustment of transmitting-receiving aperture of acousto-optic tip with lower-located and higher-located holes of intramedullary rod working end is performed. Concentration of energy of pulse operating laser signal at wavelength λ2 on set point of internal surface of tubular bone to value sufficient for its laser burning is performed in such way that it becomes phase-conjugated with respect to received signal. In control over process of intraosteal laser hole burning in tubular bone also used are data of analysis of parametres of three-dimensional Fourier-image of area of formed hole, obtained while probing said area with measuring pulse laser signal at wave length λ1. Into formed holes blocking screws are introduced. Correctness of blocking screws passage through formed holes in tubular bone and spatially matched with it holes of intramedullary rod working end are controlled by means of preliminarily introduced through soft tissue into said holes guide Kirschner's wire. In its turn, control over correctness of Kirschner's wire introduction is performed by means of guiding laser ray at wavelength λ1, spreading from inside through holes of intramedullary rod working end and corresponding holes formed in tubular bone, as well as soft tissues, directly adjacent to tubular bone in region of distal blocking of intranedullary rod.

EFFECT: invention ensures reduction of amount of intraoperational X-ray examination, minimal invasiveness and reduces operation duration.

2 cl, 4 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to mammalogy, also aims at optimised therapy of palpable benign breast abnormalities. The patient is exposed to laser irradiation with a diode laser ensured by ultrasound-aided introduction of a light guide in an abnormality. Herewith, wavelength is 690-1270 nm, and power is 1.8-4.5 Wt. While irradiation, temperature is measured along the perimetre of a palpable abnormality with an acoustic metre. At temperature 42-55°C, the exposure is terminated. In fibrous adenoma, the exposure is terminated at temperature 50-55°C. For papillary cyst, temperature is 42-45°C.

EFFECT: method aims at high-grade restoration of organ structure and function by optimised therapy of palpable benign breast abnormalities.

3 cl, 2 ex

FIELD: medicine.

SUBSTANCE: invention concerns medicine, oncology, and can be used for treating spine osteochondrosis. That is ensured by percutaneous puncture approach to an invertebral disk. Then 2% sodium bicarbonate, 1% local anaesthetic and 70° alcohol are introduced in the invertebral disk consistently in equal portions. Then the patient is exposed to pulsed laser light emitted with a quartz light guide at wavelength 950-980 nm and at power 2-5 Wt. Laser exposition is 10-15 seconds, twice. Then laser exposure is continued with performing hernia evaporation of the invertebral disk.

EFFECT: method allows ensuring simultaneous elimination of irritation and compression syndromes in treatment of spine osteochondrosis of various locations.

3 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to surgical medical tools and can be used for surgical oncotomy, namely for estimation of tumour prevalence rate and identity of resected tissue volume. A sapphire-blade system for biological tissue resection and optical diagnostics of malignancy comprises an emitter, a fluorescent radiation recorder, a scalpel with a sapphire blade fixed in a holder. In the blade body of the scalpel there are two channels along the blade edge wherein there are optical fibres. And at least one fibre is connected to the fluorescence-actuating emitter, while the other fibre is connected to the fluorescent radiation recorder.

EFFECT: enhancement of the surgical tool, higher mechanical reliability of the emitting unit.

22 cl, 7 dwg

FIELD: medicine, orthopedics, traumatology.

SUBSTANCE: one should perform percutaneous osteoperforations with surgical laser with a monofilamentous quartz light guide of 0.4 mm diameter supplied with thermostable protective covering in impulse-periodic mode at average power being 20-40 W. Osteoperforation should be fulfilled for 3-10 sec, in focus of fracture in not less than 5 points: the first 2 points at the distance of 1.0-1.5 cm against fracture area in both osseous fragments, the second 2 points at the distance of 1.0-1.5 cm against the first two points, the 5th point crosses fracture area. Through openings should be formed in osseous fracture area in planes being perpendicular to the bone. The method enables to provide complete anatomo-functional restoration of affected bone, prevent the development of complications in the form of osteomyelitis and formation of false articulations.

EFFECT: higher efficiency of stimulation.

9 dwg, 1 ex, 2 tbl

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