Invention relates to a coronary plaque liquefaction/cleaning catheter capable of reaching all coronary arteries in three dimensions and 360 degrees effective for use in atherosclerotic vascular diseases.

In particular, the invention relates to a coronary plaque liquefadion Z cleaning catheter that infuses solutions in different combinations to enter the coronary artery in different combinations to lift and remove plaques.

The Basis of the Invention

Atherosclerotic vascular disease is a chronic and progressive disease characterized by intimai and underlying lipid accumulation and inflammation in large and medium arteries. Disease begins and progresses by triggering various risk factors. Atherosclerotic process progresses slowly and insidiously, resulting in acute coronary syndrome with plaque rupture, and causes death or heart failure in many patients. Atherosclerotic plaque, which becomes prone to rupture, is considered to be a sensitive plaque.

Lipid content of the plaque, degree of inflammation, fibrous cap structure, necrotic and apoptotic cell contents, neovascularization, etc., determine plaque sensitivity. Heavy metal accumulation was encountered in recent studies on carotid atherosclerotic plaques. The condition is not dear in coronary arteries.

Primary goal of protective cardiology is to prevent the development of atherosclerotic plaque from the very beginning, if not, to stabile» existing plaques to prevent cardiovascular events. In addition to fighting risk factors and lifestyle modification, some pharmacological treatments provide plaque stabilization. Statins are important contributors to plaque stabilization with both lipid lowering effects and pleiotropic effects. In studies conducted with statins, it was shown in different patient groups that plaque content becomes more stable and cardiovascular events decrease.

In studies conducted on atherosclerotic plaques, the goal is usually to prevent the cracking of the plaque and to stop its progression if possible. Drug, intervention, or other treatments are limited in the reduction or clearance of atherosclerotic plaque. Current evidence suggests that coronary plaques predisposed to cardiac arrest are seen throughout all coronary arteries and that stenting and ballooning on these plaques do not interfere with heart attacks.

Patients do not obey recommendations such as diet, exercise, smoking cessation, coronary plaque ruptures can not be prevented and even coronary plaques can not be regressed even in patients who obey.

Current medicines (cholesterol drugs, ACE inhibitors, aspirin, etc.) slow down atherosclerosis but are very ineffective in regressing.

There is no specially designed catheter for infusion application into the coronary artery. There is no solution or drug to clean coronary plaques and regress effectively.

In European patent document no EP1202768B1 in the literature about the subject, "This present invention provides a catheter for delivering an infusion fluid to an anatomical site. According to one embodiment, catheter comprises a long tube having a plurality of exit holes along an infusion section of the catheter and a longitudinally flexible, porous member in the tube and forming a circular gap between the tube and the component. In accordance with other embodiments, the catheter includes a tube having a plurality of exit holes in a side wall of the tube. Exit holes may unite to form a flow-limiting hole in the catheter. Advantageously, the fluid in the catheter flows through all of the exit holes so that the fluid is uniformly distributed in an anatomical region. In a particular embodiment, catheter has a tube with elongated exit holes. In accordance with other embodiments, the catheter comprises an elongate tubular dement made of a porous membrane. Porous membrane is structured such that a liquid introduced into an open end of the tubular element will flow along the side walls of the tubular element at a substantially uniform speed over a length of the tubular element. In accordance with other embodiments, the catheter indudes a tubular wound spring that is attached to or received at one end of a tube and provides longitudinal flow. The fluid in the spring and a threshold equal to or greater than toe pressure, advantageously flows out radially between the spring coils. Advantageously, the liquid is distributed substantially evenly over a length of the spring.” statements are included.

Mentioned application includes a catheter conjuration for distributing fluid. Mentioned catheter configuration has a spring mechanism to ensure equal distribution of fluid. Also in the European patent document no EP2531139B1 in toe literature about the subjed; "A vascular introducer with an expandable sheath. Sheath indudes a balloon expandable portion and a self expandable portion; wherein the balloon expandable portion is remote from toe self expandable portion. The distant balloon expandable section can be narrowed to reduce the diameter of the introducer to direct the introducer to toe vasculature of a patient.” statements are included.

Mentioned embodiment includes a vascular introducer configuration having a widened sheath and a balloon expandable section.

Also in the European patent document no EP238997281 in the literature about the subject;“A catheter having a hydrophilic surface layer at least a portion of its surface intended to create a low friction surface property of the catheter by being treated with a soaking fluid prior to use of the catheter, said first and second resiliently connected with a gasket to maintain said wetting fluid a soaking liquid pocket formed from toe material layers, a container forming a cavity for carrying toe said catheter and said soaking liquid pocket, said soaking liquid pocket being opened by squeezing said soaking liquid pocket so that the soaking liquid is discharged into the container, wherein at least one of said first and second layers of said wetting fluid pocket extends beyond toe sealed enclosure to form a connection area outside the sealed enclosure, the liquid liquid pocket being connected to an inner surface of the reservoir, said connection being established only between the reservoir and the said connection area," statements are included. In the mentioned application, a set of catheters which is a reservoir carrying a wetting fluid pocket is disclosed.

Due to the disadvantages mentioned above, it was become necessary to introduce a new coronary plaque fiquefaction/cteaning catheter.

Description of the Invention

The object of the present invention from this point of the technique is to provide a coronary plaque liquefaction/ cleaning catheter which removes the present disadvantages.

Another object of die invention is to provide a structure that allows all coronary arteries to be achieved in three dimensions and 360 degrees effectively. Another object of the invention is to provide a structure which allows the coronary plaques to be retracted by administering a "liquefactor solution" through the infusion openings.

Another object of the invention is to provide a structure which allows only the desired region of the coronary arteries to be infused.

Another object of the invention is to provide a structure in which a solution is provided by a single catheter instead of using different catheters in different lengths because the coronary arteries are of different sizes.

Description of Figures

Figure-1 An illustrative representation of the coronary plaque liquefaction/cleaning catheter of the invention within the coronary artery Figured An illustrative representation of the coronary plaque liquefaction/cleaning catheter of foe invention

Reference Numbers

Detailed Description of the Invention

In this detailed description, the innovation which is subject of the invention is described with examples that will not have any limiting effect for better understanding of the subject matter.

The invention is a coronary plaque liquefaction/dearance catheter (A) for infusing solutions in different combinations to «iter foe coronary artery (1) and remove it from the common atherosclerotic plaques (6) formed in the coronary artery (1) in human or animal hearts for use in atherosclerotic vascular diseases; and characterized in that the infusion orifices (2) which allow s aid solution infusion process to take place are arranged so that the catheter body (5) on which said infusion orifices (2) are positioned 360 degrees is located on said catheter body (5) and the said catheter body (3) are arranged around said catheter body (5) in order to eliminate the necessity of using a different catheter for each different length of coronary artery (1) and to guide the guiding wire (3) characterized in that it comprises a retractable sheath (4) which permits restricted infusion by allowing the infusion openings (2) in the required region to be withdrawn by withdrawing at a distance of up to the size of tee coronary artery (1).

In figure- 1, a representation of the coronary plaque !iquefaction/cieaning catheter (A) of the invention within the coronary artery is illustrated. in figure-2, a representation of the coronary plaque liquefaction/cleaning catheter (A) of the invention is illustrated.

A coronary plaque liquefaction/cleaning catheter (A) which allows the resurgence of common atherosclerotic plaques (6) in the coronary artery (1) in human or animal hearts; characterized in that the catheter body (5) housing the 360 degree infusion holes (2) on tee catheter body (5) is provided with infusion openings (2) which allow said infusion process to take place, the positioning of said catheter body (5) , a solution inlet hole (9) used as a feed hole for the solution to be infused from said infusion holes (2) located at tee center of said catheter body (5), a different guide passage for each different sized coronary artery (1) a retractable sheath (4) positioned around said catheter body (5) to allow limited infusion by opening only infusion holes (2) in the region of need, by withdrawing at a distance of up to the size of the coronary artery (1) to remove the need for catheter, said retractable sheath (4) being located at the end point a radio opaque tip (7) resembling and adjusting how far back the sheath is to be pulled, advance and retracted bevel (10) associated with said retractable sheath (4) and providing the opening and closing of said retractable sheath (4) and said coronary plaque like fra / the cleaning catheter (A) is formed from tee main parts of the guide wire lumen (8) located in the end region.

In coronary liquefaction/cleaning catheter (A) subjected to the invention, catheter body (5) with a 360 degree infusion hole (2) is advanced through the 0.014 or 0.018 inch guide wire (3) sent to the coronary artery (1). When the mentioned guidewire (3) is inside, the retractable sheath (4) is guided by the radiopaque end (7) to the required length and is retracted with the retractor wire (10) to allow the infusion holes (2) to be opened at the desired length and distance. Since the mentioned coronary arteries (1) are of different lengths, instead of using a catheter in different lengths, the catheter body 2 is guided by the guide wire (10) at the center of the catheter body (5) with the guiding retractor wire (10) pulls in the required amount before withdrawal of the guidewire (3), allowing the opening of the catheter hole (2) to be flushed through the entire length of the coronary artery (1) and is guided to its chamber.

The solution inlet hole (9) in the center of the catheter body (5) provides for guiding the catheter body (5) through the guidewine (3) for insertion of the coronary artery 1 and retractable sheath (4) is retracted when foe guidewire 3 is contained. The infusion holes (3) are provided to be opened according to foe length of said coronary artery (1). When the infusion phase is passed, the guide wire (3) is retracted and mentioned solution inlet hole (9) is used to feed the "liquefaction solution" to the infusion holes (2).

The solution used to regress foe mentioned common atherosclerotic plaques (6) is preferably a cleaning solution. At least one of the chemicals of the anti-inflammatory, fatly tissue destabilizers, surfactants, phospholipids, collagen inhibitors, metal chelators, isotonic sodium chloride, phosphate buffered saline, antimicrobial chemistries, pH adjusters and penetrant providers, phosphatidyl choline, deoxycholic acid, caffeine, aminophylline comprising.

Mentioned solvent and penetrant chemistries contains at least one of water, dimethy!su!foxide, dimethylformamtde, methyl alcohol, ethyl alcohol, propyl alcohol, isopropyl alcohol, acetone, octano!, butanol, isopropyl myristate, oleic add, linoieic add, ethylenediamine, triethanolamine, diethanolamine, monoethanolamine.

Mentioned metal chelator contains at least one of citric add, lactic add, EDTA (ethylenediaminetetraacetic add), ATMP (amino tris (methylene phosphonic acid)), DTPMP (diethylenetriamine penta (methylene phosphonic add)), HEDP (1- Hethylethylidene- (ethylenediamine tetra (methylene phosphonic add)) and 8 -hydroxyquinoline chemicals. Mentioned antimicrobial chemicals comprises at least one of "sodium and potassium salts of salicylic acid and benzoic acid chemicals", "elemental forms and salts of metals", antibiotics, quaternary ammonium salts, 8-hydruxyqutnoiine and hydrogen peroxide.

Mentioned pH adjuster contains at least one of citric acid, acetic acid, hydrochloric acid, hydrofluoric acid, nitric acid, sulfuric acid, phosphoric acid, monosodium phosphate, disodium phosphate, sodium hydroxide, potassium hydroxide, cesium hydroxide, rubidium hydroxide, magnesium hydroxide and calcium hydroxide.

Mentioned pH value is in the range of 1-14, preferably 6-8, more preferably 7.0-7.4.

Mentioned surfactant contains at least one of linear alkyl benzene sulphonic acid, nonionic surfactant, sodium iauryi sulphate, sodium laureth sulphate, sodium dodecyl sulphate, deoxychoftc acid chemicals.

Mentioned phospholipid contains at least one of phosphatidylcholine, phosphotidylethanolamine, phosphotidyiserine, phosphotidylinositol. Mentioned fatty tissue destabilizers contains at least one of caffeine, cis-4-Hydroxy- L-proiine, amtnophylline

For the sterilization of the mentioned chemical solution; process containing at least one of fitter sterilization, autoclave sterilization, dry air sterilization, UV radiation sterilization, gamma radiation sterilization, ethylene oxide sterilization, chemical addition and sterilization techniques is conducted.

Anti-inflammatory substance contains at least one of acetyl salicylic acid, atorvastatin, colchicine, steroidal and nonsteroidal antiinflammatory agents.