EA040253B1 - INFUSION CATHETER FOR THERAPEUTIC EFFECT ON AT LEAST ONE PARTIAL OR COMPLETE OBSTRUCTION IN THE BODY CHANNEL - Google Patents

Description

The field of technology to which the invention belongs

The invention relates to an infusion catheter configured for insertion into a tubular formation (channel) in which there is at least one partial or complete obstruction to be treated. First of all, the invention relates to an infusion catheter that can be inserted into a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli. In particular, the invention relates to a catheter for cardiac surgery and interventional cardiology, for example for the treatment of obstruction or occlusion of a coronary artery leading to myocardial infarction, with improved prevention of necrosis of that part of the heart muscle dependent on this artery.

Prior Art

US Pat. No. 4,771,782 describes a method and catheter device for introducing multiple catheters into a biological vessel. According to the first variant shown in FIG. 1-7, this device has a first tubular element (channel) for conducting a flexible conductor (flexible guide wire) 10 and a pressure sensor 12, which can have various configurations, as well as (in the embodiment of Fig. 2) a second channel for introducing an infusion catheter 32, which is intended for infusion of a contrast fluid and which can be used to position the conductor 10 and another catheter or other catheters.

The pressure sensor can detect blood pressure and be used in combination with other sensors, such as temperature and pH detection, and even Doppler sensors. It should be noted that this device can be useful in many applications related to the venous system, urinary tract and esophagus (see abstract, drawings and formula).

U.S. Patent No. 4,966,148 describes various options that are developments of the options described in the cited U.S. Pat. No. 4,771,782.

From the article by Van't Veer et al., which is published in the journal Medical Engineering and Physics 31 (2009), 688-694, and whose team of authors includes Mr. N. Peils, a method and device for thermodilution by continuous infusion with the aim of determination of coronary blood flow.

On pages 689 and 690 of this article, in section 2.3, entitled Measurement protocol, two variants of an infusion catheter are described, containing a central tube for passing a guidewire inserted into a blood vessel corresponding to a coronary artery. This catheter has many small transverse holes located equidistantly near its distal end (at a distance of 3 cm from it). A variant with 4 small holes located at a distance of 0.5-1 cm from the distal end of the catheter is also described.

In an article by Aarnoudse et al., which was published in the Journal of American College of Cardiology, v. 50, No. 24, 2007, pp. 2214-2304, and whose team of authors includes Messrs. N. Peils and B. De Bruyne, describes another version of this thermodilution catheter inserted into the coronary artery and positioned near the stenotic area into which the infusion catheter is advanced by sliding along a central guidewire equipped with at its distal end with a temperature sensor, after which it is inserted using a Y-shaped connector into the tubular formation Y1 (see Fig. 1, p. 2296). With this embodiment, the temperature sensor is located distal to the distal end of the catheter, while this distal end is close to the stenotic area. In the described embodiment, distal to the distal end of the catheter is an inflatable perivascular occlusive device. The second Y-piece is used to inject saline into the infusion channel of the catheter at room temperature and at a flow rate of 8-25 ml/min. The results of coronary pressure and temperature measurements are fed to the interface of the medical analyzer Radi and displayed. The pressure measured at the distal end of the guide catheter is recorded using a pressure transducer and displayed on the interface. Tests performed in humans were identical to those in dogs, except that different perivascular hemorrhage transducers and occlusive devices were used. The catheter used had a distal end tapered and bent at an acute angle in order to reduce flow through one of the four holes closest to it, located at a distance of 5 mm from the distal end of the infusion catheter.

U.S. Patent Application No. 2005/113798 further describes a method and apparatus for treating the internal surfaces of blood vessels, having various variations, characterized, for example, by the number and location of small transverse infusion holes for infusion of a fluid consisting mainly of saline. At the distal end of the infusion catheter there may be an inflatable balloon located distal to the small infusion holes, which, respectively, are located in front of this balloon (see, for example, Fig. 29-32 of this document).

WO 2009/049823 further describes a catheter comprising a first tubular element defining a first lumen and a first perforation and a second tubular element defining a second lumen and a second perforation. In this case, the second tubular element is configured to receive the first tubular element with the formation of a chamber between them in such a way that one end of the second tubular element is in contact with the end of the first tubular element. The first and second tubular members are configured to form a first fluid passage through the first perforation to the observation site and a second fluid passage from the observation section through the second perforation into the chamber (see FIGS. 1-10).

US Patent Application No. 2014/0323887, owned by Boston Scientific, describes a thermodilution catheter system and a method for determining blood flow levels.

According to this document, the catheter comprises a fluid channel 82 formed between the inner and outer tubular members 14, 12 to form an indicator fluid, and a guidewire channel 30 formed by the inner tubular member. At the distal end of the outer tubular element there is one of the holes 40 for the infusion fluid, allowing the fluid to go outside the catheter, into the blood vessel 80. To detect the temperature of the fluid at the point of its exit from the catheter, the conductor 30 is provided with a temperature sensor 32 located opposite holes 50 made in the distal wall of the inner tubular element 14 so that the flow of fluid enters the sensor to measure its temperature (see drawings and abstract). To distribute the fluid outside the outer tube of the infusion catheter, several small holes can be provided, located at equal distances in the same axial plane of the catheter (see Fig. 1A).

WO 2012/164481 describes a system for measuring blood flow using an optical approach, specifically optical fiber.

EP 1930045 further discusses an implantable medical device having acoustic sensors for measuring mitral blood flow.

US Pat. No. 6,585,689 B1 describes an aortic catheter having a proximal occluding element positioned in the ascending aorta and a distal fixation element positioned in the descending aorta distal to the aortic arch (see abstract and corresponding figure 27).

The purpose of this aortic catheter is to induce cardiac arrest in order to selectively segment and perfuse the aorta with extrapulmonary circulation.

The problem solved by the present invention is completely different from the problem solved by the catheter according to this patent, which is also specialized for the aortic arch, in contrast to the catheter according to the invention, which is suitable for general use.

US Pat. No. 6,689,097 B2 discloses a catheter with a so-called bypass channel. According to this document, a catheter is used, passed over a guidewire and positioned, according to the standard procedure, directly under the occluded artery. The bypass then shunts blood flow, thereby embrittling the entire atherosclerotic plaque by applying high pressure (including negative pressure) to the carotid occlusion to substantially reverse blood flow through the obstructed (eg, occluded) artery. After that, a stent is inserted into the artery and expanded. According to the inventor of the present invention, the vascular catheter provides the advantage of creating collateral blood flow to solve the problem of stroke during endovascular procedures (see abstract).

It should be noted that the described design is completely different from the proposed, and it is aimed at solving the problem of occlusion or atherosclerosis in a completely different way than the present invention provides, which will be discussed later.

US Pat. No. 5,415,636 describes a catheter provided with a dilatation balloon 24 as well as an internal catheter which has fine holes 56 for delivering drug(s).

However, when the balloon is brought into a state of dilatation, these drug delivery holes are proximal to the balloon; therefore, the balloon-carrying external catheter must be retracted to open these holes for drug removal.

Thus, the design of this device differs from the design of the device according to the invention.

US Pat. No. 8,177,704 describes a catheter having an inflatable balloon 122 and small holes 129 distal to the balloon.

However, these holes 129 are not used to inject fluid, but instead, to detect characteristics (such as pressure and temperature) of the blood distal to the inflated balloon using a sensor whose components are located in the central lumen 125 (see Fig. 4 and 5 ).

Therefore, this document is absolutely irrelevant to the present invention.

Application EP 3009161, filed by Innovation for Heart and Vessels (Poland), offers an intravascular microcatheter designed to deliver active substances, such as drugs, and equipped, according to the first variant, with uniformly distributed pores 5 in the amount of from 20 to 200, made on distal end of the catheter.

The second option uses an inflatable balloon 9 (see Fig. 4 and 5).

It is noted that the balloon is designed to create a proximal vessel occlusion (see paragraph [0012], column 3, lines 29-31) in order to increase the efficiency of delivery of active substances

- 2 040253 only to the target zone by preventing the movement of active substances in the opposite direction, which is especially desirable in the case of the use of toxic substances such as cytostatics, and the balloon stabilizes the catheters (see column 3, lines 31-35).

However, in this solution, the balloon is not intended to treat the obstruction, and this is its fundamental difference from the present invention.

US Patent Application No. 2010/198186 also discloses a catheter having an inflatable balloon and allowing injecting a liquid agent through the lumen that serves the wire, which agent is a contrast liquid. Small holes 310b are also provided for the removal of the specified liquid, located distal to the balloon (see, for example, Fig. 5 and 1, as well as column 4, lines 1-9, preceding paragraph [0041], and paragraph [0049], which describes variant according to Fig. 5).

In contrast to the present invention, this application lacks the function of treating obstruction using an inflatable balloon.

Another irrelevant document is US 2009/018498.

The essence of the invention

The main task of the invention is to solve a new technical problem, which is to provide the possibility of a therapeutic effect on at least one partial or complete obstruction (occlusion) in a tubular formation while simultaneously acting on the wall of a tubular formation in which there is an obstruction (occlusion). ), at least on a part of this wall located distal to the obstruction (occlusion).

At the same time, the specified main task provides such a solution to this new technical problem, which makes it possible to treat partial or complete obstruction of any type in a tubular formation, mainly in a tubular formation corresponding to a channel in the body of an animal or a person, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, with the possibility of simultaneous treatment of the wall of a tubular formation in which there is an obstruction (occlusion), at least that part of the wall that is located distal to the obstruction (occlusion).

In addition, the main task is to solve this problem by developing a catheter for cardiac surgery, especially for the treatment of obstruction (occlusion) of the coronary artery leading to myocardial infarction, with improved prevention of necrosis of the part of the heart muscle that depends on this artery.

Another main objective of the invention is to solve a new technical problem, which is to enable the simultaneous treatment of partial or complete obstruction (occlusion) of a blood vessel and hypothermic treatment of tissues distal to said obstruction (occlusion) in order to prevent any subsequent degradation of these tissues.

The problem solved by the invention is to overcome these technical problems by developing a device with a simple design that allows it to be manufactured easily and reliably, with good reproducibility in technical and medical terms.

Accordingly, according to its first aspect, the invention relates to an infusion catheter having an elongated, essentially tubular shape with a longitudinal axis X-X, an essentially tubular outer wall, defining distal and proximal ends and configured to be inserted into a tubular formation having a wall with internal and external surfaces and at least one partial or complete obstruction or occlusion present in it, subject to therapeutic effects. In the outer wall of the catheter, at its distal end, one or more through infusion holes are made for fluid infusion. Proximal to one or more infusion holes, in the proximal part of the catheter, on its outer surface, at least one obturating element is formed for temporary obturation, configured with the possibility of a therapeutic effect on the specified obstruction or occlusion and permutation between non-obturating (initial) and obturating (working) positions . In this case, the catheter is capable of infusing the infusion fluid distal to the obturating element in the obturating position.

According to its second aspect, the invention relates to an infusion catheter having a distal and a proximal end and configured to be inserted into a tubular formation having an inner and outer wall and presenting at least one partial or complete obstruction (occlusion) to be treated. In the outer wall of the catheter, at its distal end, one or more small infusion holes are made for fluid infusion. Proximal to one or more infusion holes, in the proximal part of the catheter, on its outer surface, at least one obturating element is formed for temporary obturation, configured with the possibility of a therapeutic effect on the specified obstruction (occlusion) and rearrangement between non-obturating (initial) and obturating (working) provisions. In this case, the catheter is capable of producing a therapeutic effect on at least one specified obstruction (occlusion) present in a tubular formation, which is preferably a channel in the body of an animal or a person, selected from the group consisting of blood vessels, coronary or other arteries , urinary tract, esophagus and pulmonary alveoli, and at the same time carry out the infusion of the infusion fluid distal to the obturating element in the obturating position.

According to its third aspect, the invention relates to a method for treating a partial or complete obstruction present in a tubular formation having internal and external walls and representing a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli.

The method includes the following operations:

a catheter is used that is configured to be inserted into the specified tubular formation with at least one partial or complete obstruction (occlusion) to be treated, and at the distal end of which one or more small infusion holes are made for infusion of liquid, while being proximal to the specified infusion holes , on the proximal side of the infusion catheter formed at least one obturating element for temporary obturation, configured to act on the specified obstruction (occlusion) and rearranged between non-obturating (initial) position and obturating (working) position;

inserting said catheter into said tubular formation, the obturating device of which is in its original state, with the obturating device brought close to (in particular, inside) said obstruction (occlusion);

conduct (before or after performing the operation of the introduction of the catheter) conductor through the catheter until its distal end passes for partial or complete obstruction in the specified tubular education;

translating the obturating element into a temporary obturating state to define a limited space between the outer wall of the catheter, the inner wall of the tubular formation to be treated, and the partial or complete obstruction present in the tubular formation, or to influence the obstruction (occlusion) through compression;

infusion of the infusion fluid is carried out in the specified limited space or distal to the obstruction (occlusion) through the specified infusion holes in order to carry out a therapeutic effect on the specified partial or complete obstruction (occlusion) or on the walls of the tubular formation distal to the specified obstruction (occlusion).

According to a particular embodiment of the infusion fluid, a temperature is applied to protect the material or tissues of the wall of the tubular formation. This temperature may correspond to a temperature cold enough to hibernate the canal tissues to be protected for a predetermined period of time. Specialists must know how to determine the temperature to ensure protection of tissues adjacent to the obstruction (occlusion) from its distal side.

Thus, within the framework of cardiac surgery, it becomes possible, when the obturation is supported by the obturating element, which is in the working (obturating) position, to carry out, for example, infusion of the infusion fluid, which is given a temperature of 6-8 ° C below the temperature of the blood, for 5-15 minutes , preferably about 10 minutes. The temperature is measured by means of a temperature sensor placed either in the catheter or on the conductor distal to the infusion ports. Under the described conditions, the temperature of the surrounding tissue will be lower than the temperature of the blood by 3-6°C, for example by 4°C.

EFFECT: invention allows to provide a therapeutic effect on the corresponding partial or complete obstruction in any channel, mainly in the channel in the body of an animal or a person, selected from the group consisting, without limitation, of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, while simultaneously exposing the canal wall distal to the opening in order to protect the material or tissues forming said wall.

In relation to a channel in the body of an animal, specifically to blood vessels, in particular to a coronary or other artery, obstruction (occlusion) is usually associated with thrombosis, stenosis or blood clot. In the urinary tract, it usually corresponds to a calculus (stone), such as a bladder or urethral stone, or a kidney stone.

As mentioned, according to its first aspect, the invention relates to an infusion catheter having an elongated, essentially tubular shape with a longitudinal axis X-X, a substantially tubular outer wall defining the outer surface and the inner surface defining the distal and proximal ends (D , P) catheter, and configured for insertion into a tubular formation having inner and outer walls and present in it at least one partial or complete obstruction or occlusion to be treated. At the distal end (D) of the outer wall of the catheter, one or more through infusion holes for fluid infusion (LI) are made, and on the proximal side (P) of the infusion catheter, proximal to the infusion holes, at least one

- 4 040253 obturating element for temporary obturation, which can be rearranged between non-obturating (initial) and obturating (working) positions. Thus, the catheter is configured to act on said obstruction or occlusion and to infuse an infusion fluid (LI) distal to the obturator in the obturator position.

According to a particular embodiment, the catheter according to the invention is characterized in that it contains:

a) a first substantially tubular member of flexible but substantially non-expandable and substantially non-collapsible material configured to define a first channel for receiving the guidewire and having an outlet at the distal end (D) of the catheter, and

b) a second substantially tubular member of flexible but substantially non-expandable and substantially non-collapsible material, configured to define a second infusion fluid (LI) channel, with one or more infusion holes extending through the wall the second element of the catheter, allowing the infusion of infusion fluid (LI) from the second channel outside the device.

It should be understood that in the context of the invention, the diameters of the first and second channels are essentially constant, at least in the region of the occlusive element and, in particular, along the length of the catheter within the tubular formation to be treated, and the diameter of each channel does not depend on in what (initial or working) position is the obturating element.

The diameter of the first channel may differ from the diameter of the second channel.

Materials and methods for the manufacture of various catheter elements are well known to specialists in the relevant industry, including from the documents discussed above, see, in particular, US 5415636, column 4, page 50 - column 6, page 55, or US 2010/0198186 , paragraph [0061], and also US 2009/018498, paragraphs [0124] and [0131].

According to one variant, the second channel is blocked at its distal end with an impermeable wall in order to force the infusion fluid to pass through the infusion holes.

According to a specific embodiment, the first tubular element is located coaxially to the catheter. In this case, according to this variant, the second tubular element can also be located coaxially, while having a larger diameter than the first element coaxial with it, and the wall of the second element forms the outer wall of the catheter.

According to one modification, the first element, the axis of which is parallel to the longitudinal axis of the catheter, has a common wall with the second element, and according to this modification, the second element can form the outer wall of the catheter with the formation of the second channel, localized between the second and first elements.

According to another specific embodiment, the catheter according to the invention is characterized in that the temporary occlusive element comprises an inflatable balloon located on the outer surface of the catheter and supplied with an inflating fluid through a balloon inflation channel formed inside or on the surface of the catheter. In this case, the balloon inflation fluid may contain a dilute or undiluted contrast agent.

According to a specific embodiment, in order to ensure the passage of the infusion fluid, when the balloon is inflated, a pressure difference is created. The easily inflatable balloon can be inflated with pressure from 0.5-0.6 MPa to a maximum pressure of about 1.4-1.5 MPa, while the second channel (infusion tube) can withstand pressure up to about 3.5-4.0 MPa. Therefore, to provide the desired infusion performance, it is sufficient to increase the pressure of the infusion fluid. In practice, the catheter is connected to an automatic injection pump (not shown) to provide the programmed flow rate.

According to another specific embodiment, the catheter according to the invention is characterized in that at least some of the infusion holes are made in the outer wall at a distance from one another in one plane transverse to the longitudinal axis of the catheter.

In a further specific embodiment, the catheter according to the invention is characterized in that at least some of the infusion holes are made in the outer wall at a distance from one another along a line essentially parallel to the longitudinal axis of the catheter.

According to another specific embodiment, the catheter according to the invention is characterized in that the conductor is equipped with one or more temperature sensors, at least one of which is mounted on the distal part of the conductor with the ability to measure the temperature of the infusion fluid distal to the infusion holes made in the distal part of the catheter.

According to a specific embodiment, the catheter of the invention is characterized in that it comprises one or more temperature sensors, of which at least one sensor is installed inside the catheter close to at least one infusion port and is configured to measure the temperature of the infusion fluid in situ before it exits through infusion holes behind the distal side of the catheter.

In one particular embodiment, the catheter according to the invention is characterized in that it is provided with at least one internal opening which communicates with a chamber formed between the internal and external tubular elements and through which the infusion fluid (LI) is supplied to at least one of the outer small holes for infusion of the infusion fluid outside the catheter with the ability to measure the temperature of the infusion fluid due to the presence of a conductor equipped with a temperature sensor capable of being transferred to a position opposite to the specified inner hole.

In another specific embodiment, the catheter according to the invention is characterized in that it contains a proximal channel for the infusion of an infusion fluid, which is a heat transfer fluid administered at a temperature below the temperature prevailing inside said tubular formation.

According to one specific embodiment, the catheter according to the invention is characterized in that, when used in relation to obstructions (occlusions) capable of dissolving in a corresponding fluid, for example, to a kidney or gallstone, it contains a proximal channel (C1) for infusion of an infusion fluid containing a substance, capable of dissolving obstruction (occlusion). Substances suitable for this purpose should be known to those skilled in the art. For example, substances that dissolve these stones are ammonium chloride NH ₄ Cl or ammonium nitrate NH4NO3.

According to another specific embodiment, the catheter according to the invention is characterized in that it contains a proximal channel for the infusion of an infusion fluid, which may be a fluid containing at least one drug for therapeutic effects on tissues adjacent to the obstruction (occlusion). Suitable formulations should be known to those skilled in the art. For example, an aqueous suspension or dispersion of a drug for inhibiting restenosis, in particular a polyionic cyclodextrin derivative, combined with a growth factor, for example, a growth factor that binds heparin, as described in US patent No. 5874419, can be used as such a drug. a restenosis-inhibiting drug using saline solution containing octreotide, in particular radioactively labeled with the isotope Indium-111, for example, at a dose of 0.02 μg per 1 ml of fluid administered, together with heparin at a content of 200 IU / ml, as described in Camezind et al. Journal of Cardiovascular Pharmacology, v. 43, no. 1, January 2004, or US 2005/0239743. An antithrombotic or wound healing agent may also be used in an effective amount to cause a tissue healing/repair response near or distal to the obstruction (occlusion). In particular, such a preparation may contain or be a non-reducing saccharide or a sulfated analogue thereof, such as a non-reducing mono- or disaccharide, for example glucose, sucrose, fructose or their sulfated analogues, in particular the sodium salt solution of sucrose octasulfate described in document WO 94/ 22885; somatostatin receptor 1 antagonist as described in US Pat. No. 7,084,117; a prodrug (predecessor) of NO, for example selected from L-arginine, L-lysine, or mixtures thereof. The other anti-restenosis agent may be selected from a drug for inhibiting smooth muscle cell proliferation, a cytoskeletal inhibitor, and a triene-based macrocyclic antibiotic. These antirestenotic agents may be water soluble or water insoluble. A water-soluble agent may belong to the peptide family, for example, while an example of a water-insoluble preparation is a mud preparation.

In one particular embodiment, the catheter according to the invention is characterized in that the guidewire is provided with one or more temperature sensors, at least one of which is mounted on the distal part of the guidewire with the ability to measure the temperature of the infusion fluid withdrawn through the infusion holes on the distal part of the catheter distal to or proximal to the obstruction. (occlusion) in a tubular formation.

In another specific embodiment, the catheter according to the invention is characterized in that it contains one or more temperature sensors, at least one of which is located inside the catheter close to at least one infusion port and is configured to measure the temperature of the infusion fluid in situ, before it exits. through the infusion holes behind the distal side of the catheter.

According to a specific embodiment, the catheter according to the invention is characterized in that it is provided with at least one internal hole that communicates with the chamber formed between the inner and outer tubular elements, and through which the infusion fluid is supplied to at least one of the outer fine holes for its infusion outside the catheter, with the ability to measure the temperature of the infusion fluid due to the presence of a conductor equipped with a temperature sensor capable of being transferred to a position opposite to the specified internal hole.

In another specific embodiment, the catheter according to the invention is characterized in that it contains at least one visual marking system that corresponds to the proximal and/or intermediate position of the catheter, and/or its distal position and allows medical personnel to accurately locate the catheter within the tubular formation to be treated. .

According to another specific embodiment, the invention is characterized in that the marking system comprises one or more radiopaque markers.

In another specific embodiment, the catheter according to the invention is configured to be inserted into a tubular formation, which is a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli.

According to its second aspect, the invention relates to an infusion catheter having distal and proximal ends and configured to be inserted into a tubular formation having a wall with inner and outer surfaces and at least one partial or complete obstruction (occlusion) to be treated. In the outer wall of the catheter, at its distal end, one or more small infusion holes are made for fluid infusion, and proximal to one or more infusion holes on the specified outer wall, at least one obturating element is formed for temporary obturation, configured for therapeutic effects on obstruction (occlusion ), reversible between non-obturating (initial) and obturating (working) positions in order to carry out a therapeutic effect on at least one partial or complete obstruction (occlusion) present in a tubular formation, which, in particular, is a channel in the body of an animal or human , selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, while infusion of the infusion fluid distal to the obturator element in the obturator position.

According to its third aspect, the invention also relates to a method for treating a partial or complete obstruction present in a tubular formation.

This method includes the following operations:

a catheter is inserted into said tubular formation, made according to any variant within the framework of the first aspect of the invention, in particular, containing a temperature sensor at its distal end, and this insertion is carried out with the obturator device in its original state, before the obturator device is installed near, preferably inside the specified obstruction (occlusion);

conduct (before or after performing the operation of the introduction of the catheter) conductor through the catheter until its distal end passes for partial or complete obstruction in the specified tubular education;

translating the obturating element into a temporary obturating state to define a limited space between the outer wall of the catheter, the inner wall of the tubular formation to be affected, and the partial or complete obstruction present in the tubular formation, or to influence the obstruction (occlusion) by compression;

the infusion fluid is infused into the specified limited space or distal to the obstruction (occlusion) through the infusion holes to effect a therapeutic effect on the specified partial or complete obstruction (occlusion) or on the walls of the tubular formation distal to the specified obstruction (occlusion).

In a specific embodiment, this method includes the use of a heat transfer infusion fluid, which is given a temperature suitable for thermal treatment of the walls of the tubular formation distal to the obstruction (occlusion).

In this embodiment, the tubular formation is a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, and the infusion fluid is given an appropriate temperature to ensure hypothermia of the tissues of this channel .

According to a specific embodiment, the method of the invention comprises, after completion of the heat treatment, surgical treatment by inserting into the area of obstruction (occlusion) an expanding device, such as a stent, well known to those skilled in the relevant industry.

According to another specific embodiment, this method after completion of the expansion operation includes postoperative thermal treatment using a catheter inserted in the specified area of partial or complete obstruction in order to more effectively restore tissues in the specified channel.

Thus, within the framework of cardiac surgery, it becomes possible, when the obturation is supported by the obturating element, which is in the working (obturating) position, to carry out, for example, infusion of the infusion fluid, which is given a temperature of 6-8 ° C below the temperature of the blood, for 5-15 minutes , preferably about 10 minutes. This temperature is measured by means of a temperature sensor installed in the catheter or on the conductor distal to the infusion holes. Under these conditions, the temperature of the surrounding tissue will be lower than the temperature of the blood by 3-6°C, for example by 4°C.

The invention makes it possible to treat a partial or complete obstruction to be treated in any channel, preferably in a channel in the body of an animal or human, selected from the group consisting, without limitation, of blood vessels, coronary or

- 7 040253 other arteries, urinary tract, esophagus and pulmonary alveoli, while exposing the canal wall distal to the opening in order to protect the material or tissues forming said wall.

In relation to a channel in the body of an animal, specifically to blood vessels, in particular to a coronary or other artery, obstruction (occlusion) is usually associated with thrombosis, stenosis or blood clot. In the urinary tract, it usually corresponds to a calculus (stone).

All specific variations within the first aspect of the invention are, of course, applicable to its second and third aspects.

It will not be difficult for those skilled in the relevant industry to understand that the invention provides for the use of a simple device that is easy to manufacture, safe and reliable for industrial production and medical use, and through which obstructions (occlusions) of various types in various channels can be acted upon.

List of figures

In FIG. 1 is a schematic partial longitudinal sectional view of a first embodiment of a catheter according to the invention, provided with an occlusive element (such as an inflatable balloon) located proximal to the infusion ports and shown in operating position in a channel such as a coronary artery.

In FIG. 2 shows in longitudinal section and on an enlarged scale a portion of the catheter of FIG. 1, located near the obstruction (occlusion), with the obturating element in the working position, i.e. performing compression of the obstruction (occlusion) simultaneously with the infusion of the infusion fluid distal to the obstruction.

In FIG. 3 the catheter is shown in cross section along plane III-III (see FIG. 2).

In FIG. 4, the catheter is shown in cross section in plane IV-IV (see FIG. 2).

In FIG. 5 schematically shows a second embodiment of a catheter according to the invention, provided with an occlusive element such as an inflatable balloon.

In FIG. 6 shows in longitudinal section and on an enlarged scale part of the catheter according to FIG. 5 with obturating element in working (inflated) state.

In FIG. 7 the catheter is shown in cross section along plane VII-VII (see FIG. 5).

In FIG. 8 the catheter is shown in cross section by plane VIII-VIII (see FIG. 5).

In FIG. 9 the catheter is shown in cross section along plane IX-IX (see FIG. 5).

In FIG. 10 the second version of the catheter according to FIG. 5-9 is shown in an operating position proximal to the obstruction to be treated, such as a bladder, kidney or gallbladder calculus.

In FIG. 11 in a view similar to that used in FIG. 2 shows a third embodiment of a catheter according to the invention, provided with an occlusive element (such as an inflatable balloon) positioned within the obstruction to be treated.

In FIG. 12 the catheter of FIG. 11 is shown in cross section by plane XII-XII.

In FIG. 13 part of the catheter according to FIG. 11 is shown in longitudinal section with the conductor in the retracted position and with the temperature sensor positioned opposite the opening opening into the central channel in which the conductor is located.

In FIG. 14 in a view similar to that used in FIG. 2 shows a fourth embodiment of a catheter according to the invention, provided with an occlusive element (such as an inflatable balloon) positioned within the obstruction to be treated and comprising a first temperature sensor mounted on a guidewire and a second temperature sensor mounted within the infusion fluid conduit adjacent with at least one infusion port, and capable of measuring the temperature of the infusion fluid in situ before it exits the catheter through the infusion ports at the distal portion of the catheter.

Information confirming the possibility of carrying out the invention

Example 1 of a catheter according to the invention.

In FIG. 1-4 shows a first basic version of a catheter, designated generally as 10 and configured for insertion into a tubular formation 50 that has an inner 54 and an outer 52 wall, and in which there is at least one partial or complete obstruction or occlusion 60 to be treated. . The catheter 10 has an elongated, substantially tubular shape defining a proximal end P, a distal end D, and a longitudinal axis X-X. The catheter has a substantially cylindrical outer wall with an outer surface 12b and an inner surface 12a.

According to the invention, in the outer wall of this device (catheter) 10, at its distal end D, one or more small infusion holes 16, 18, 20, 22 are made for the infusion of liquid LI. At the same time, proximal to one or more infusion holes, from the side of the proximal end P of the infusion catheter, on its outer surface 12b there is at least one obturating element 70 for temporary obstruction, configured to act on the specified obstruction (occlusion) while simultaneously infusing the infusion fluid LI distal to the obturator in the obturator position.

- 8 040253

According to a particular embodiment, the catheter according to the invention is characterized in that it contains:

a) a first substantially tubular member 28 which is made of a flexible but substantially non-expandable and substantially non-collapsible material, configured to define a first conduit 29 to receive the guidewire 30 and having an outlet 29a at the distal end D devices;

b) a second, essentially tubular element 12 of flexible, but essentially non-expandable and essentially non-destructible material, configured to define a second channel 14 for receiving infusion fluid LI; while one or more infusion holes 16, 18, 20, 22 pass through the wall of the second element 12 of the device, allowing the removal of the infusion fluid LI from the second channel outside the device.

According to the variant shown in FIG. 1-4, in order to force the infusion fluid LI to pass through the infusion ports 16, 18, 20-22, the second channel is blocked at its distal end by an impermeable wall 12c.

In one embodiment, the first element 28 is positioned coaxially with the catheter 10. In this case, as shown in FIG. 1-4, the second element 12 can also be positioned coaxially, having a larger diameter than the first coaxial element 28, with the wall of the second element forming the outer wall of the catheter.

According to another embodiment, the catheter of the invention is characterized in that the temporary occlusive member 70 comprises an inflatable balloon 72 located on the outer surface of the catheter and supplied with inflating fluid through a balloon inflation channel 80 formed within or on the surface of the catheter 10 having an inlet 82 and connected with the internal volume 74 of the balloon 72 through the hole 84. In this case, the fluid for inflating the balloon, such as a gas (such as air) or liquid, may contain an undiluted contrast agent.

According to a specific implementation, in order to ensure the passage of the infusion fluid, when the balloon is inflated, a pressure difference is created: an easily inflatable balloon can be inflated with a pressure of 0.5-0.6 MPa to a maximum pressure of about 1.4-1.5 MPa, while the second channel ( infusion tube) can withstand pressure up to about 3.5-4.0 MPa. Therefore, to provide the desired infusion performance, it is sufficient to increase the pressure of the infusion fluid.

In practice, the catheter is connected to an automatic injection pump (not shown) to provide the programmed flow rate.

According to another specific embodiment, the catheter according to the invention is characterized in that it contains at least one temperature sensor 32, installed at the distal end D of the catheter and located so that it can measure the temperature of the infusion fluid LI outside the catheter, near the infusion holes 16, 18, 20, 22.

According to another specific embodiment, the catheter according to the invention is characterized in that at least some of the infusion holes 16, 18, 20, 22 are made in the outer wall at a distance from one another in one plane transverse to the longitudinal axis of the catheter, as shown in FIG. 4.

According to a further specific embodiment, the catheter according to the invention is characterized in that the infusion fluid is a heat transfer fluid administered at a temperature below the temperature prevailing inside said tubular formation.

According to one particular embodiment, the invention is characterized in that if an obstruction (occlusion), such as a kidney or gallstone, can be dissolved in an appropriate fluid, the infusion fluid is an infusion fluid containing a substance that dissolves the obstruction (occlusion). A person skilled in the relevant industry should know the substances suitable for this application. For example, ammonium chloride NH ₄ Cl or ammonium nitrate NH4NO3 can be used to dissolve stones.

According to another specific embodiment, the catheter according to the invention is characterized in that the infusion fluid is a fluid containing at least one drug for treating the tissue adjacent to the obstruction (occlusion). The specialist should be aware of drugs suitable for such use. For example, the drugs mentioned above can be used as a drug.

According to another specific embodiment, the catheter according to the invention is characterized in that the conductor (guide wire) 30 is provided with one or more temperature sensors 32, at least one of which is mounted on the distal part of the conductor with the ability to measure the temperature of the infusion fluid distal to the infusion holes, made in the distal part of the catheter, and distal to the obstruction (occlusion) in the tubular formation, as shown in Fig. 1 and 2.

According to a further specific embodiment, the catheter according to the invention is characterized in that it contains at least one visual marking system which corresponds to the proximal and/or intermediate position of the catheter and/or its distal position and enables the medical personnel to accurately locate the catheter within the tubular formation to be 040253 reaping treatment.

According to another specific embodiment, the invention is characterized in that the marking system comprises one or more radiopaque markers positioned to accurately locate at least the distal end of the catheter, the infusion ports, and the obturator.

In one particular embodiment, the catheter is characterized in that said tubular formation 50 is a channel in the animal or human body selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus, and pulmonary alveoli.

Example 2 catheter according to the invention.

The second basic variant of the invention is shown in Fig. 5-10, on which components having the same functions have similar numerical designations, but increased by 100.

Thus, the catheter, designated generally as 110, comprises a conductor 130, a temperature sensor 132 mounted thereon, an occlusive element 170 (specifically, a balloon 172) fed through a channel 180 having an inlet 182 and associated with the internal volume 174 of the balloon 172 through hole 184.

In this second basic version, the first tubular element 128, whose axis is parallel to the longitudinal axis X-X of the catheter 110, is formed in such a way that its wall is in contact with the second tubular element 112, which in this version also forms the outer wall of the catheter 110. In this case, the second the channel 114 may be defined by the space between the second tubular 112 and the first tubular 128.

According to this embodiment, in order to force the infusion fluid LI to pass through the infusion holes 116, 118, 122, the second channel 114 is blocked at its distal end by an impermeable wall 112c.

According to another specific embodiment, the catheter according to the invention is characterized in that at least some of the infusion holes 116, 118, 122 (see Fig. 7, 9) are made in the outer wall at a distance from one another in one plane transverse to the longitudinal axis catheter as shown in Fig. 9. Of course, this embodiment of the infusion holes is also acceptable for the first embodiment in FIG. 1-4 and vice versa.

Example 3 of a catheter according to the invention.

The third basic variant is shown in Fig. 11-13, in which components having the same functions have similar numerals, additionally increased by 100.

Thus, the catheter, designated generally as 210, comprises a conductor 230, a temperature sensor 232 mounted thereon, an occlusive element 270 (specifically, a balloon 272) fed through a channel 280 having an inlet 282 and associated with the internal volume 274 of the balloon 272 through hole 284.

According to this third basic variant, the catheter according to the invention is characterized in that it contains at least one inner hole 236, which passes through the wall of the inner tubular element 228 to communicate the first channel 229 with the second channel 214 formed between the inner and outer tubular elements 228, 212, and through which the infusion fluid LI enters the region of the outer small holes 216, 218, 220, 222 for its removal outside the catheter. The catheter provides the ability to measure the temperature of the fluid in situ in the catheter due to the presence of a conductor provided with a temperature sensor 232 capable of being moved to a position opposite the specified internal hole 236.

Example 4 catheter according to the invention.

The fourth basic variant is shown in Fig. 14, in which components having the same functions have similar numerical designations, additionally increased by 100.

Thus, the catheter, designated generally as 310, comprises a conductor 330, a temperature sensor 332 mounted thereon, an obturating element 370 (specifically, a balloon 372) fed through a channel 380 having an inlet 382 and associated with the internal volume 374 of the balloon 372 through hole 384.

According to this fourth basic variant, the catheter according to the invention is characterized in that it contains one or more temperature sensors 332, 342, and at least one temperature sensor 342 is installed inside the catheter, specifically in the second channel 314, close to at least one infusion port (in in this case to port 320) and configured to measure the temperature of the infusion fluid in situ, before it exits through the infusion ports, beyond the distal side of the catheter.

In this embodiment, the guidewire carries a temperature sensor 332 which is outside the catheter and, unlike the third embodiment of FIG. 11-13 can remain in a relatively unchanged position, since it does not need to be retracted. Thus, the measurement of the temperature of the infusion fluid LI is performed simultaneously in situ inside the catheter before infusion and outside after it exits the channel 350.

- 10 040253

According to its second aspect, the invention relates to an infusion catheter 10; 110 having distal and proximal ends D, P configured to be inserted into tubular formation 50; 150 having a wall 52; 152 with inner surface 54; 154 and outer surface 56; 156 and present in it at least one partial or complete obstruction (occlusion) 60; 160, subject to therapeutic effects. At the same time, one or more small infusion holes 16 are made in the outer wall of the catheter at its distal end D; 116, 18; 118, 20, 22; 122 for fluid infusion LI, a proximal to one or more infusion holes on the outer surface in the proximal part P of the infusion catheter 10; 110 formed at least one obturator element 70 for temporary obturation, configured to act on the specified obstruction (occlusion) 60 when conducting in the state of obstruction infusion of infusion fluid LI distal to the obturator element 70. This implementation aims to provide a therapeutic effect on at least one specified partial or complete obstruction (occlusion) in a tubular formation (which is predominantly a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli) while infusing the infusion fluid distally an obturating element in an obturating position.

According to its third aspect, the invention also relates to a method for treating at least one partial or complete obstruction (occlusion) present in a tubular formation. This method, for which all four described variants of the catheter are suitable, includes the following operations:

a) introducing into said tubular formation a catheter, made according to any particular embodiment described in the framework of the first aspect of the invention, and having a temperature sensor at its distal end; insertion is carried out with the obturator in its rest position until the obturator is placed near, preferably inside, a partial or complete obstruction (occlusion) (as illustrated in Figures 1-4 and 11-14) or proximal to the obstruction (as illustrated Fig. 5-10), and

b) is carried out before or after operation a) guidewire through the catheter until its distal end passes for partial or complete obstruction in the specified tubular formation.

According to a variant of the method and depending on the specific treatment situations, the order of operations a) and b) can be reversed, after which the following operations are performed:

c) positioning the obturator in a temporary obturator position to define a limited space between the outer wall of the catheter, the inner wall of the tubular formation to be treated, and the partial or complete obstruction present in the tubular formation (FIGS. 5-10), or to effect a therapeutic effect on obstruction (occlusion) by means of compression (FIGS. 1-4 and 11-14);

d) infusion of the infusion fluid is carried out into the specified limited space (Fig. 5-10) or distal to the obstruction (occlusion) (Fig. 1-4 and 11-14) through the indicated infusion holes in order to effect a therapeutic effect on the specified partial or complete obstruction ( occlusion) or on the walls of the tubular formation distal to the specified obstruction (occlusion).

According to a specific variant of the method, a heat-transfer infusion fluid is used with a temperature selected for thermal treatment of the walls of a tubular formation distal to the obstruction (occlusion).

If the specified tubular formation is a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, the temperature of the infusion fluid is adjusted in such a way as to ensure hypothermia of the tissues of the specified channel.

In a particular embodiment, upon completion of said thermal treatment, surgery is performed by inserting an expanding device, such as a stent (well known to those skilled in the art), into the area of obstruction (occlusion).

According to another specific variant of the method, in order to more effectively restore tissues in the indicated channel, after completion of the expansion operation, postoperative thermal treatment is performed using a catheter inserted into the indicated area of partial or complete obstruction.

Example 5 Application of the embodiment of FIG. 1-4 and 11-14 in cardiac surgery and interventional cardiology.

In the context of cardiac surgery, the invention aims to provide selective hypothermia, i.e. selective cooling of part of the heart muscle, in patients with acute myocardial infarction. This cooling (hypothermia) should begin several (about 10) minutes before the occluded artery is recanalized, i.e. the artery responsible for the infarction. In this case, cooling should continue for several (about 10) minutes even after recanalization of the artery. The indicated durations are given as examples only: they can be set differently for different patients, depending on the results of previous studies.

Myocardial infarction is known to be caused by occlusion of a coronary artery. Such a sudden okk

- 11 040253 Lusion is a threat to the survival of that part of the heart muscle that depends on this artery. Rapid recanalization of the blocked artery can limit the extent of damage. Therefore, such rapid recanalization is part of the treatment of the acute phase of infarction, the so-called primary angioplasty. However, it has been shown that abrupt reperfusion of the artery itself is the cause of the expansion of necrosis of heart cells. This phenomenon is referred to as reperfusion injury. Thus, part of the positive effect of primary angioplasty is lost due to problems associated with reperfusion. It is this reperfusion injury that is prevented by the use of hypothermia according to the invention. As a result, the proposed method can limit the extent of the infarction. The extent of the infarction is the most important prognostic factor after the onset of myocardial infarction. Therefore, hypothermia according to the invention, allowing to limit this vastness, improves the prognosis for patients.

The advantage of the method of selective hypothermia according to the invention is that the desired temperature is reached very quickly, with only the part of the affected heart muscle being cooled and the degree of congestion is substantially reduced. As a consequence, only a few systemic effects (if any) should be feared.

As should be clear from the previous description, the catheter according to the invention combines the properties of a conventional balloon catheter and an infusion catheter and has dimensions very close to those of a conventional balloon catheter. However, it can be constructed as follows.

The catheter has three channels (lumen):

the first channel (clearance) 29; 229 or 329, parallel to the longitudinal axis (see Fig. 1-4 and 11-14), for example, formed by the first tubular element 128, referred to as monorail (monorail), defining the first clearance (see Fig. 5-10), which allows you to advance a catheter over any 0.014 inch (0.36 mm) diameter wire 30, 130, 230, 330, as well as over a wire equipped with a temperature sensor 32, 132, 232, 332 and/or a pressure sensor;

the second channel (lumen) 14, 114, 214, 314, formed by the outer wall of the second tubular element 12, 112, 212, 312 of the catheter 10, 110, 210, 310, passing from the proximal part to the distal infusion holes 16, 18, 20, 22 , or 116, 118, 122, or 216, 218, 220, 222, or 316, 318, 320, 322, which are located in the distal part and through which the infusion fluid (for example, saline or other LI fluid) is removed from the infusion channel ;

the third channel 80, 180, 280, 380, defining the third lumen 82, 182, 282, 382, communicating through the hole 84, 184, 284, 384 with the internal volume of the obturator element, in this case the balloon 72, 172, 272, 372, which can be deflated to its original state or inflated from this state to the inflated (working) state (see Fig. 1-3, 6, 8, 10, 11, 13 and 14). This inflation of the balloon can be accomplished by injecting an LC gas or liquid from the proximal end of the catheter, which (if desired) may contain a dilute contrast medium to allow the exact position of the catheter, in particular the balloon, and infusion ports to be traced relative to the obstruction (occlusion).

Inflating and deflating a balloon located, for example, in front of the distal transverse infusion holes, at a distance of one to several centimeters or a few millimeters from them, is carried out similarly to conventional balloons. However, according to a specific embodiment, in order to ensure the passage of the infusion fluid, when the balloon is inflated, a pressure difference is created: an easily inflatable balloon can be inflated with a pressure of 0.5-0.6 MPa to a maximum pressure of about 1.4-1.5 MPa, while the second channel (infusion tubular element) withstands pressure up to about 3.5-4.0 MPa. Therefore, to provide the desired infusion performance, it is sufficient to increase the pressure of the infusion fluid. In practice, the catheter is connected to an automatic injection pump (not shown) to provide the programmed flow rate.

In a variant of cardiac surgery with catheter insertion near the heart, the length of the catheter can be about 20-22 cm, and its outer diameter is less than 1 mm, for example 0.95 mm. The small infusion holes may, for example, have a diameter of about 150 μm, be located at a distance of 7-8 mm from the distal end of the catheter and have angular positions corresponding to 0°, 180° and/or 90° and 270°, i.e. located one opposite the other and/or with mutual displacement along the axis of the catheter, as shown in Fig. 1-14 for four different options.

It should be noted that the proximal end of the catheter is provided with two connectors. The first connector is used to connect the infusion pump that delivers the infusion fluid LI, and the second connector C2 is used to connect a syringe or pump when inflating or deflating the balloon 72, 172, 272, 372.

Selective cooling procedure.

A patient with acute myocardial infarction who is indicated for primary angioplasty is placed, as usual in such cases, on the catheterization table and the delivery catheter 10, 110, 210, 310 is brought through the femoral or radial artery.

A thermistor-equipped wire 30, 130, 230, 330, such as St Jude Medical's PressureWire brand, is advanced through the delivery catheter. This conductor is advanced into the distal part of the ar-

Claims (18)

terii through occlusion, which caused a heart attack. The catheter 10, 110, 210, 310 is then connected to the infusion pump and any air bubbles are removed from the tubulars. After that, a catheter is placed on the conductor 30, 130, 230, 330, the balloon 72, 172, 272, 372 is brought to the coronary occlusion 60, 160, 260, 360 and the balloon is immediately inflated 72, 172, 272, 372 in this area to avoid reperfusion of the infarcted segment. Thereafter, the infusion fluid LI, eg sterilized saline (which may be heparinized), is infused at the temperature desired for heat treatment, starting, for example, at operating room temperature. This infusion, when obturating the artery with a balloon, is carried out for 10 minutes. The temperature distal to the catheter is monitored by at least one temperature sensor (eg, a thermistor) 32, 132, 232, 332, 342 located in the distal part of the artery. According to the protocol of the initial stage, the temperature in the distal part of the coronary artery should be approximately 6-8°C lower than the temperature of the blood. Under these conditions, the temperature near the myocardial tissue was approximately 4°C lower than the blood temperature. After about 10 minutes, the infusion fluid (eg, physiological saline) at room temperature is replaced with an infusion fluid (eg, physiological saline) at about 4° C. and the obturator balloon is simultaneously deflated. This allows blood to flow through the catheter and mix with cold saline. The temperature of the mixture during this period is controlled by a thermistor located in the distal part of the artery. This temperature should be 4-5°C lower than the blood temperature. It is known that under these conditions, the temperature of the adjacent area of the myocardium is approximately 4°C lower than the temperature of the blood. After about 10 minutes, the infusion of saline is stopped. Finally, the catheter 10, 110, 210, 310 according to the invention is removed and the stent is placed using another suitable catheter according to the technique used. Of course, the duration of the infusion and the temperature of the infusion fluid can be varied, i.e. the method of the invention also covers other infusion times and temperatures. Although versions of the catheter have been described with a different number of distal infusion holes, for example with 4 transverse holes (see Fig. 1-4 and 11-14) or with three such holes (see Fig. 5-10), the axes of which lie in the same plane, as well as with one distal hole, of course, other combinations of such holes are possible, including those distributed along a line parallel to the longitudinal axis of the catheter, as shown in Fig. 7. The catheter according to the invention can be used with other conductors, and the order of operations during its introduction can be changed. Thus, the catheter according to the invention is a combination of infusion and balloon catheters. The purpose of such a combination is to provide simultaneous obturation of the vessel and infusion of the infusion fluid in order (according to the options in Figs. 1-4 and 11-14) to produce a therapeutic effect on the tissues located behind the occlusion, or to carry out (as described below) the dissolution of the occlusion according to the variant of FIG. 5-10. Example 6 Application of the embodiment of FIG. 5-10 for the destruction of obstructions such as stones (calculi). Using a procedure similar to that described in Example 5, but positioning the infusion ports in front of an obstruction (occlusion) such as a stone (calculus) in the urinary tract, after inflation of the balloon 172, a fluid can be infused to destroy, in particular dissolve, the obstruction (occlusion) in for the required period of time during routine monitoring. In another embodiment, specifically targeted at breaking an obstruction such as a calculus, the second conduit 114 may be made open at its distal end so that the infusion fluid can exit not only through the fine infusion holes 116, 118, 122, but also through the distal opening of the second channel. Such an implementation is acceptable for all embodiments of FIG. 1-14. Thus, the catheter according to the invention has a wide range of applications, i.e. can be used to act on obstructions (occlusions) of various types in tubular formations of various types, as described. In doing so, the invention covers all technical equivalents of the means discussed in the description and presented in Figs. 1-14, which complete the description of the invention, forming its integral part. CLAIM 1. Infusion catheter (10; 110; 210; 310), having an elongated, essentially tubular shape with a longitudinal axis X-X, the outer wall (12; 112; 212; 312), essentially, a tubular shape, defined - 13 040253 outer surface (12b) and inner surface (12a), distal and proximal ends (D, P) and configured to be inserted into a tubular formation (50; 150; 250; 350) having a wall with an inner surface (54 ; 154; 254; 354) and the outer surface (56; 156; 256; 356) and present in it at least one partial or complete obstruction (60; 160; 260; 360) or occlusion subject to therapeutic effects, while in the outer wall of the catheter at its distal end (D) has one or more through infusion holes (16, 18, 20, 22; 116, 118, 122; 216, 218, 220, 222; 316, 322) for infusion of infusion fluid (LI ), a proximal to one or more infusion holes in the proximal part (P) of the catheter (10; 110; 210; 310), on its outer surface (12b), at least one obturating element is formed (70; 170, 270; 370) for temporary obstruction, and the catheter is configured to act on said obstruction (60; 160; 260; 360) or occlusion during infusion of infusion fluid (LI) in the state of obstruction into the area distal to the obturator element (70; 170, 270; 370), wherein the catheter further comprises: a) a first substantially tubular element (28; 128; 228; 328) of flexible, but essentially non-expandable and essentially non-destructible material, configured to define a first channel (29; 129; 229; 329) for receiving the conductor (30; 130; 230; 330) and having an outlet (29a) at the distal end (D) of the catheter, b) a second, essentially tubular element of flexible, but essentially non-expandable and essentially indestructible material, configured to define the specified outer wall (12; 112; 212; 312), tightly connected at the distal end (D ) with the first element, and the second channel (14; 114; 214; 314) for receiving infusion fluid (LI), while one or more infusion holes (16, 116, 216, 316; 18, 118, 218, 318; 20 , 120, 220, 320; 22, 122, 222, 322) pass through the outer wall of the second tubular element (12; 112; 212; 312), allowing the infusion fluid (LI) from the second channel to be infused outside the device; And c) one or more temperature sensors (32; 132; 232; 332; 342), of which at least one sensor (32; 132; 232; 332) is installed on the distal part (D) of the conductor with the ability to measure the temperature of the infusion fluid distally infusion port at the distal end of the catheter. 2. The catheter according to claim 1, characterized in that the first element (28; 228; 328) is located coaxially with the longitudinal axis XX of the catheter (10; 210; 310), while the second element (12; 212; 312), which is located coaxially to the catheter and thus to the first element, has a larger diameter than the first element (28; 228; 328), and its wall forms the outer wall (12) of the catheter, in which said infusion holes are made. 3. The catheter according to claim 1, characterized in that the first element (128) has an axis parallel to the longitudinal axis X-X of the catheter and comes into contact with its wall with the second element (112) of the catheter. 4. The catheter according to any one of claims 1 to 3, characterized in that the temporarily obturating element (70; 170; 270; 370) contains a balloon (72; 172; 272; 372) having the initial position in the uninflated state and the working position in inflated state, located on the outer surface of the catheter and supplied with inflating fluid through the channel (80, 180; 280; 380) for inflating the balloon, formed inside or on the surface of the catheter (10; 110; 210; 310), while the inflating fluid ( LC) for balloon inflation contains dilute or undiluted contrast agent. 5. Catheter according to any one of claims 1 to 4, characterized in that at least some of the infusion holes (16, 18, 20, 22; 216, 218, 220, 222; 316, 318, 320, 322) made in the outer wall at a distance from one another and located in the same plane transverse to the longitudinal axis of the catheter. 6. Catheter according to any one of claims 1 to 5, characterized in that at least some of the infusion holes (116, 118, 122) are made in the outer wall at a distance from one another along a line essentially parallel to the longitudinal axis catheter. 7. Catheter according to any one of the preceding claims, characterized in that it contains a proximal channel (C1) for the infusion of an infusion fluid (LI), which is a heat transfer fluid administered at a temperature below the temperature prevailing inside said tubular formation. 8. Catheter according to any one of claims 1 to 7, characterized in that, when used in relation to an obstruction or occlusion (160) capable of dissolving in a corresponding fluid, for example, to a kidney or gallstone, it contains a proximal channel (C1) for infusion of an infusion fluid containing a substance capable of dissolving the obstruction or occlusion (160). 9. The catheter according to any one of claims 1 to 8, characterized in that it contains a proximal channel (C1) for infusion of an infusion fluid (LI) containing at least one drug for therapeutic effects on tissues near the obstruction or occlusion (60; 160). 10. The catheter according to any one of claims 4-9, characterized in that the balloon (72; 172; 272; 372) is made with the possibility of inflating with pressure from 0.5-0.6 MPa to a maximum pressure of 1.4-1.5 MPa, while the second channel receiving the infusion fluid (LI) withstands pressure up to about 3.5-4.0 MPa. - 14 040253 11. The catheter according to any one of claims 1 to 10, characterized in that at least one temperature sensor (342) is installed inside the catheter close to at least one infusion port (320) and is configured to measure the temperature of the infusion fluid (LI) in situ until it exits through the infusion holes beyond the distal side of the catheter. 12. The catheter according to any one of claims 1 to 11, characterized in that it has at least one internal hole (236), providing communication between the first channel (29; 129; 229; 329) and the second channel (14; 114; 214 ; 314), designed to supply infusion fluid (LI) to at least one hole (216) from the outer holes (216, 218, 220, 222) for its infusion outside the catheter, and providing the ability to measure the temperature of the infusion fluid due to the presence of a conductor (30; 130; 230) provided with a temperature sensor (32; 132; 232; 332) capable of being moved to a position opposite the inner hole (236). 13. The catheter according to any one of claims 1 to 12, characterized in that it is formed with the possibility of insertion into a tubular formation (50; 150), which is a channel in the body of an animal or a person, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli. 14. A method for treating at least one partial or complete obstruction or occlusion present in a tubular formation, including the following operations: a) enter into the specified tubular formation of a catheter, made according to any one of paragraphs.1-13; while the introduction is carried out with an obturating element for temporary obturation, which is in its original state, until the installation of the obturating element near, preferably inside, partial or complete obstruction or occlusion or proximal to it, while the obturating element (70; 170, 270; 370) for temporary obturation contains an inflatable balloon (72; 172; 272; 372), having the initial position in the uninflated state and the working position in the inflated state, located on the outer surface of the catheter and supplied with inflating fluid through the channel (80, 180; 280; 380) for inflating a balloon formed inside or on the surface of the catheter (10; 110; 210; 310); b) is carried out before or after operation a) guidewire through the catheter until its distal end passes for partial or complete obstruction or occlusion in the specified tubular formation; c) placing the obturator in a temporary state of obturation to define a limited space between the outer wall of the catheter, the inner wall of the tubular formation to be treated, and the partial or complete obstruction or occlusion present in the tubular formation, or to treat the obstruction or occlusion by compression, wherein the inflating fluid is supplied by means of an inflating pump at pressure to compress the obstruction or occlusion; d) by means of an infusion pump, the infusion fluid is infused into the specified limited space or distal to the obstruction or occlusion through the infusion holes to effect a therapeutic effect on the partial or complete obstruction or occlusion or on the walls of the tubular formation distal to the specified obstruction or occlusion; And e) control the temperature of the infusion fluid distal to the infusion holes by means of at least one of the temperature sensors (32; 132; 232; 332) located at the distal end of the conductor. 15. The method according to claim 14, characterized in that a heat-transfer infusion fluid is used at a temperature selected for thermal treatment of the walls of the tubular formation distal to the obstruction or occlusion. 16. The method according to claim 14 or 15, characterized in that if the specified tubular formation is a channel in the body of an animal or human, selected from the group consisting of blood vessels, coronary or other arteries, urinary tract, esophagus and pulmonary alveoli, the temperature infusion fluid is adjusted in such a way as to ensure hypothermia of the tissues of the specified channel. 17. The method according to claim 15 or 16, characterized in that, upon completion of said thermal treatment, a surgical intervention is performed by inserting an expanding device, such as a stent, into the area of obstruction or occlusion. 18. The method according to claim 17, characterized in that in order to more effectively restore tissues in the specified channel, postoperative thermal treatment is carried out after completion of the expansion operation, using a catheter inserted into the specified area of partial or complete obstruction or occlusion. -