Catheter (various variants) and system for isolating region in hollow organ of mammal

Abstract

To provide a catheter for isolating the interior of a hollow organ of a mammal.SOLUTION: A catheter includes: two balloons individually and separately disposed along a catheter body configured to be inserted into a lumen of a hollow organ and configured to be inflated to isolate the interior of the hollow organ therebetween; a functional channel extending within the catheter body and having a functional opening provided in the catheter body between the balloons, the functional channel configured to generate a negative pressure in the isolated interior to draw a liquid or gaseous medium from the isolated interior via the functional opening; and two ring-shaped protrusions surrounding the functional opening, provided in the catheter body between the balloons. Accordingly, the functional opening is located between the ring-shaped protrusions, and the ring-shaped protrusions are configured to, when the negative pressure is generated, maintain a prescribed distance between mucosal tissue of the hollow organ between the inflated balloons and the functional opening.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to medicines, and more particularly to medical devices used to diagnose, monitor, and / or treat inflammatory, autoimmune, infectious, benign, and / or malignant diseases occurring in the hollow organs of mammals or other organs connected to these hollow organs, particularly diseases of the pancreas, bile duct, liver, and gastrointestinal tract, as well as diseases and injuries of mammalian hollow organs, fistulas, stenoses, diverticular dilatations associated with aneurysms, and other diseases of hollow organs. [Background technology]

[0002] Known in the art are various devices and applications used for the diagnosis and / or treatment of inflammatory, autoimmune, infectious, benign, and / or malignant diseases occurring in the hollow organs of mammals, in particular diseases of the pancreas, bile duct, liver, as well as gastrointestinal wall defects, hollow organ wall injuries, diverticular dilatation related to aneurysms, hollow organ stenosis, hollow organ hemorrhage, and several other diseases of hollow organs and organs connected to hollow organs.

[0003] According to the guidelines for the diagnosis and treatment of pancreatic cancer, the main techniques that allow for the identification of the histological type of neoplasm are fine-needle percutaneous core biopsy, fine-needle functional biopsy, cytological analysis of epithelial tissue scrapings (also called brush biopsies in the art), diagnostic laparoscopy with biopsies, and cytological analysis of washings obtained from the peritoneal cavity during laparoscopy or laparotomy (Pancreatic adenocarcinoma guidelines. National Cancer Comprehensive Network. 2019 Version 2.2019). These officially recommended biopsy techniques are based on different principles, and therefore cannot be considered the closest prior art in relation to the present invention.

[0004] Specifically, ultrasound techniques for studying the pancreas are known in the art (Minko, AB, Complex beam diagnostics of pancreatic diseases / AB Minko, BC Pruchansky, LI Korytova. - SPb: Hippokrat, 2001. - 134 p.; Marti Nez-Noguera, A., Montserrat, E., Torrubia, S., et al., 2001) Ultrasound of the pancreas: update and controversies. Eur Radiol, 11: 1594-1606). Ultrasound is based on the evaluation of changes in wave reflection and absorption from organ tissues and allows for the determination of the glandular contours, liver contours, and alternating hyperechoic and hypoechoic zones. Furthermore, ultrasound allows for the determination of the formation and diameter of the duct of Wirsung, the formation and diameter of the bile duct, and other formations and their diameters. The main drawback of ultrasound is that the experimental results depend on the qualifications of the specialist and the resolution of the equipment. In this case, the sensitivity of ultrasound examination is 70% to 80%. If the size of the formation is less than 1.5 cm, the efficiency of ultrasound is greatly reduced. Specifically, ultrasound does not allow for the detection of intraductal neoplasms, a complete evaluation of the pancreatic ducts, evaluation of the biochemical composition of pancreatic juice and bile, and cytological examination of pancreatic juice and bile.

[0005] Also known in the art is a method of endoscopic ultrasound examination based on the same principle as the aforementioned ultrasound method (see Ogawa M., Kawaguchi Y., 2011, Iglesias-Garcia J, 2012). The advantage of endoscopic ultrasound examination over ultrasound is that biopsies can be performed very close to the location of interest. A convex probe allows for the examination of pseudoformations, if present, by fine-needle functional biopsy, followed by cytological examination. The disadvantages of endoscopic ultrasound examination are the need for highly skilled specialists, the need for anesthetic assistance, high cost, and, in some cases, lack of ability to perform the examination due to certain anatomical features. Furthermore, endoscopic ultrasound examination is not suitable for performing cytological diagnosis of the liver and bile ducts; only a small amount of cytological material can be obtained by performing aspiration, which makes it difficult to interpret the obtained cytological material and results in a high rate of false positive and false negative results. Furthermore, endoscopic ultrasound examination does not allow for analysis of the nature of the composition of bile or pancreatic juice.

[0006] Also known in the art are fine-needle biopsies, in which fine-needle core biopsies are always used in combination with the aforementioned ultrasound methods and endoscopic ultrasound examinations, allowing for obtaining material for histological examination (Hruban RH, Takaori K., Klimstra DS. An illustrated consensus on the classification of pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasms. Am J. Surg. Pathol. 2004. Vol. 28 (8) P. 977-87). Fine-needle biopsies are the main method used to histologically demonstrate pancreatic diseases. Disadvantages of fine-needle biopsies include possible complications such as bleeding, fistula formation, abscesses, and metastasis of cancer cells along the puncture channel, as well as false-positive or false-negative results in uninformative tissue specimen examinations. Furthermore, fine-needle biopsies are not suitable for diagnosing bile duct and gallbladder diseases and do not allow for laboratory evaluation of bile or pancreatic juice.

[0007] Also known in the art is the method of spiral computed tomography (MSCT) of venous contrast (Callery MR et al., 2009; Klaub M. et al., 2009). Spiral computed tomography is based on computer-aided processing of thin "slice" tomograms, assessment of the degree of contrast medium absorption by glandular or tumor tissue, and measurement of duct diameter. Spiral computed tomography allows visualization of formations and determination of whether acute or chronic inflammatory changes are observed in the corresponding organ based on changes in organ densitometry parameters. The drawbacks of spiral computed tomography are its significantly reduced sensitivity when formations are less than 1.5 cm in size and its low sensitivity and specificity when diagnosing intraductal neoplasms. Furthermore, spiral computed tomography does not allow histological confirmation of diseases or the analysis of pancreatic secretions.

[0008] Also known in the art is the method of endoscopic retrograde cholangiopancreatography (ERCP) (Kawaguchi Y., Ogawa M., Omata F. Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography. World Journal of Gastroenterology 2012. Vol. 18 (14). P. 1635-1641). In endoscopic retrograde cholangiopancreatography, lesion formation and stones appear in the form of filling defects. Disadvantages of endoscopic retrograde cholangiopancreatography include the need for anesthetic assistance, several limitations that prevent reliable operation, and procedure-related injuries, potentially resulting in adverse pancreatitis or acute cholangitis.

[0009] Also known in the art is an endoscopic aspiration method for aspirating pancreatic juice from the inside of the duodenum by stimulating the pancreatic excretory function with Chirhostim™, a synthetic analog of secretin (Suenaga M., Sadakari Y., Almario JA, et al. Using an endoscopic distal cap to collect pancreatic fluid from the ampulla. Gastrointest Endosc. 2017;86 (6): 1152-1156; Kanda M., Sadakari Y., Borges M., et al. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013;11 (6): 719-730). Endoscopic aspiration is used to sample material for subsequent cytological and / or molecular genetic analysis. The disadvantages of the endoscopic aspiration method are the lack of public acceptance and the limited amount of sampled pancreatic secretions due to the short duration of the procedure, which limits the duration of drug action. It should be noted that the composition of pancreatic juice may change when secretin or its analogs are administered, so that in this case the sampled pancreatic secretions do not have their natural composition and therefore, their function is stimulated by the drug, making it impossible to assess the actual composition and secretory clearance of pancreatic juice. The endoscopic aspiration method is also unsuitable for collecting and analyzing bile.

[0010] Also known in the art is the use of magnetic resonance imaging (MRI) to assess neoplastic and inflammatory changes in the pancreas and / or bile duct (Akisik MF, Sandrasegaran K., Aisen AA Dynamic secretin enhanced MR cholangiopancreatography. RadioGraphics. 2006. Vol. 26. P. 665-677). Magnetic resonance imaging is a non-invasive method that provides improved sensitivity and specificity when used in combination with radiographic opacification or stimulation of pancreatic excretory function. The disadvantage of magnetic resonance imaging is the inability to evaluate the composition and clearance of bile or pancreatic juice and to perform cytological examination thereof.

[0011] Also known in the art are methods for performing nasopancreatic or biliary drainage followed by isolated sampling of the substrate (Handa K., Minami T., Shimizu A., et al. Roles of ERCP in the Early Diagnosis of Pancreatic Cancer. Diagnostics 2019, 9 (1), 30; Budzinsky SA, Shapovalyants SG, Fedorov ED, Shabrin AV Endoscopic transpapillary pancreatic stenting in the treatment of pancreatic fistulas (with a commentary by AG Krieger). Journal named after NI Pirogov. 2017;(2): 32-44). Nasopancreatic or biliary drainage is used to treat inflammatory pancreatic diseases and to demonstrate their cytological status. It is also suitable for analyzing the composition of biological fluids. Furthermore, it is a single method that allows for the independent sampling of pancreatic juice and bile. A drawback of nasopancreatic or biliary drainage is its complexity. The use of nasopancreatic or biliary drainage was first described in 1980, but it was not a routine method and was only used in highly specialized facilities to solve a limited range of tasks, primarily for treating acute pancreatitis. In some cases, particularly due to the presence of anatomical features, nasopancreatic or biliary drainage may not be performed and may result in various complications such as pancreatitis, cholangitis, and bleeding.

[0012] Also known in the art are two-channel Dreiling tubes used to perform duodenal intubation (Stevens T., Conwell DL, Zuccaro G., et al. A prospective crossover study comparing secretin-stimulated endoscopic and Dreiling tube pancreatic function testing in patients evaluated for chronic pancreatitis. Gastrointestinal Endoscopy. 2008. 67 (3). P. 458-466; Pollack BJ, Grendell JH. Where have all the Dreiling tubes gone? Am J Gastroenterol. 2006 Feb;101 (2): 356-9). Dreiling tubes allow for non-invasive sampling of pancreatic juice and bile followed by biochemical and / or cytological testing of the samples, as well as daily clearance determinations. The disadvantage of the Dreiling tube is that it does not allow selective sampling of duodenal contents and leads to retrograde sampling of intestinal contents. The passive nature of fecal sampling leads to partial loss of the distal section due to duodenal peristalsis. However, passive positioning of the tube, achieved by the weight of the olive at the distal end of the tube and peristalsis of the digestive tract, requires excessive time for tube positioning and the acquisition of radiographs of its position. Here, it is difficult to provide proper positioning of the tube channel for sampling pancreatic juice and bile. The use of stimulating drugs, such as secretin, cannot be considered a suitable solution because they only increase the excretion of carbonate buffer provided by pancreatic cells; that is, only the activity of the epithelial tissue cells lining the duct is stimulated, while most of the exocrine gland's mechanisms remain inactive.Therefore, the Dreiling probe does not allow for the detection of adenocarcinoma, mucinous tumors, and neuroendocrine tumors. Furthermore, the Dreiling tube is an alternative to endoscopic retrograde cholangiopancreatography and may only be used to diagnose chronic pancreatitis; intraductal mucinous and cystic formations and malignant tumors cannot be detected in situ using the Dreiling tube. Furthermore, when the Dreiling tube is used, it is very difficult to evaluate bile secretion due to the passage of some bile or pancreatic juice through the duodenum next to the Dreiling tube.

[0013] Also known in the art are transnasal pancreatic duct stents that are inserted into the main duct of the pancreas using endoscopic techniques (Osnes M., Petersen H., Schrumpf E. Comparison of juice obtained during duodenal aspiration and cannulation of the main pancreatic duct after stimulation with exogenous secretin in man. Scand J Gastroenterol. 1978;13 (4): 453-8; Minami T., Hanada K., Hirano N., et al. Clinical Usefulness of Serial Pancreatic-Juice Aspiration Cytological Examination and Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Small Pancreatic Cancer. 152, Issue 5, Supplement 1, Page S897; Bi Y., Ji B., Raimondo M. How to suction pancreatic juice from the duodenum: Endoscope, catheter, or cap-assisted No. 86 (6). 2017 Gastrointestinal Endoscopy. P. 1157-1159). During endoscopic papilosphincterotomy, a nasal pancreatic duct stent allows for the insertion of a probe and thus the acquisition of pancreatic secretions. The disadvantage of a nasal pancreatic duct stent is its traumatic nature, leading to the formation of pancreatitis, cholangitis, or obstructive jaundice. In 3% to 10% of cases, endoscopic retrograde cholangiopancreatography can cause acute pancreatitis, which requires special preventive treatment for all patients. Furthermore, during papilosphincterotomy, the large lumen can be damaged, resulting in bleeding.It should be noted that transnasal pancreatic duct stents may only be used in highly specialized centers by professionals experienced in the procedure.

[0014] Also known in the art are two-lumen duodenal probes that are inserted through the nasal passages under endoscopic control, allowing the duodenal probe to be advanced through the pyloric duodenal area (Bi Y., Ji B., Raimondo M. How to suction pancreatic juice from the duodenum: Endoscope, catheter, or cap-assisted? 86 (6). 2017 Gastrointestinal endoscopy. P. 1157-1159; Go VL, Hofmann AF, Summerskill WH. Simultaneous measurements of total pancreatic, biliary, and gastric outputs in humans using a perfusion technique. Gastroenterology 1970;58:321-328). Disadvantages of duodenal probes include the inability to selectively sample pancreatic juice and bile and the lack of a barrier to mixing of intestinal and stomach contents with feces, which can lead to activation of pancreatic enzymes and digestion of biological material within the probe. Furthermore, it should be noted that the design of duodenal probes does not allow for the influence of pancreatic juice outflow from the pancreas, so that the pancreas must be stimulated with drugs such as secretin in order to obtain the fluid and perform its testing.

[0015] Also known in the art are pancreatic juice aspiration devices configured to aspirate pancreatic juice by using an endoscope formed as a cap fitted onto a fiberscope, which cap allows the collection of pancreatic secretions after stimulation of the organ's exocrine function (Suenaga M, Sadakari Y, Almario JA, et al. Using an endoscopic distal cap to collect pancreatic fluid from the ampulla (with video. Gastrointest Endosc 2017;86:1152-1156)). Disadvantages of aspiration devices are the complexity of the procedure, which can only be performed in highly specialized centers, and the small amount of pancreatic secretions collected (the available amount of pancreatic secretions is an important aspect for molecular testing). In this case, procedures based on the use of aspiration devices are performed with the aid of anesthetics, and the procedures cannot be performed for long periods of time.

[0016] Known in the art are methods for diagnosing viral hepatitis in blood using serological and molecular genetic methods. In any case, in 20% of cases, the disease remains undiagnosed due to the viral life cycle and its affinity for both hepatocytes and bile duct epithelial tissue, leading to the development of viral cholangitis and chronicity of the disease (Shakhgildyan IV, Mikhailov MI, Onishchenko GG. Parenteral viral hepatitis (epidemiology, diagnosis, prevention). Moscow: GOU VUNMTS MZ RF, 2003; Burgart LJ. Cholangitis in Viral Disease. Mayo Clinic Proceedings; 1998. Vol. 73 (5); 479-482). Diagnostic methods do not allow for the acquisition of bile for further laboratory analysis.

[0017] Known in the art are methods for diagnosing liver diseases (viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, liver tumors) by performing a percutaneous biopsy followed by histological and molecular genetic analysis (Bunt EM Liver Biopsy Diagnosis of Hepatitis: Clues to Clinically Meaningful Reporting. Mo Med. 2010;107 (2): 113-118). In some cases, such methods lead to complications (hemorrhage, biliary peritonitis). At the same time, in about 30% of cases, it is not possible to reveal any pathological changes. Moreover, such methods are used exclusively for primary diagnosis and are virtually never used repeatedly, for example, to monitor the growth pattern or development and progression of the disease.

[0018] Also known in the art are methods for treating acute pancreatitis by placing a stent in the lumen of the main pancreas to restore pancreatic enzyme outflow. Such methods are used to treat and prevent pancreatitis after endoscopic retrograde cholangiopancreatography (Mozharovsky VV, Mutnykh AG, Zhukov IN, Mozharovsky KV. Stenting of the main pancreatic duct influences the treatment results obtained for patients with acute pancreatitis. Surgery. Journal named after NI Pirogov. 2019;(9):13-17; Dumonceau JM., Andriulli A., Elmunzer BJ., et al. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46 (9):799-815). The drawback of this method is that the stenting procedure can only be performed in highly specialized centers, and in some cases, the procedure is no longer possible due to the anatomical features of the patient's luminal system. Furthermore, the procedure does not solve the problem of pancreatitis due to the disruption of pancreatic juice outflow associated with duodenal paresis.

[0019] Furthermore, intestinal fistulas occur in an average of 1% to 3% of patients after surgery on abdominal organs (Smotrin IS Obturating agents for treating gastrointestinal fistulas. Journal of the State Medical University for Practicing Physicians. - 2007. - No. 4). The overall mortality rate associated with this condition ranges from 16.5% to 57.5%, the postoperative mortality rate associated with this condition ranges between 10% and 21.4%, and the highest mortality rate is observed for disembodied intestinal fistulas, ranging between 36% and 71.7%. For embodied intestinal fistulas, the mortality rate barely reaches 4%.

[0020] Known in the art is a method for the treatment of gastrointestinal fistulas by using a system for generating negative pressure, which is based on the continuous suction of all diseased waste from the abdominal cavity, thereby healing the defect (Bobkiewicz A, Walczak D, Smolinski S. et al. Management of enteroatmospheric fistula with negative pressure wound therapy in open abdomen treatment: a multicenter observational study. Int Wound J. 2017 Feb;14 (1): 255-264; D'Hondt M., Devriendt D., Van Rooy F. et al. Treatment of small-bowel fistulae in the open abdomen with topical negative-pressure therapy. Am J Surg. 2011;202 (2): e20-4). Furthermore, in cases where this method is used, statistical data collected by the same authors show that such defects do not terminate (do not heal) in 30% to 47% of cases due to the contents continuously produced and received from the lumen of the hollow organ.

[0021] Furthermore, there are a large number of different sealing devices that aim to isolate the lumen of hollow organs with intramural defects. However, the great variety of such devices implies difficulties in their implementation and in achieving the desired effect. Furthermore, all such known devices are intended only to separate the lumen of hollow organs having wall defects, and not to affect the area adjacent to the wall defect (Vitsyn BA, Blagitko EM. Formed and unformed external intestinal fistulas. - Novosibirsk: Nauka. -1983. - 142 p.; Makarenko TP, Bogdanov AV. Gastrointestinal fistulas. - M.: Medicine. - 1986. - 144 pp. USSR AS 764685, M. class A 61 M 27 / 00. Obturator for temporary closure of a gastrointestinal fistula / VM Udod and EG Karsten. By application 2723729 / 28-13. Declared 12 / 22 / 78. Published 09 / 23 / 80. BI 35).

[0022] Known in the art are methods for the treatment of gastrointestinal profuse bleeding that are based on the use of endoscopic methods, clipping, ligation, injection of sclerosing or vasoactive agents into the mucosal layer, as well as coagulation using thermal and electrical methods (Anjiki H, Kamisawa T, Sanaka M, Ishii T, Kuyama Y. Endoscopic hemostasis techniques for upper gastrointestinal hemorrhage: A review. World J Gastrointest Endosc. 2010;2 (2): 54-60). Furthermore, in cases of bleeding from decaying tumors, necrotizing esophagitis, or nonspecific erosive colitis, i.e., cases in which diffuse mucosal bleeding occurs without an obvious source, such known methods remain ineffective, while they do not allow objective control of the stability of hemostasis.

[0023] Known in the art is a method for diagnosing luminal aneurysm-related dilations by administering an intraluminal intravascular catheter, with or without a stent, which involves guiding the catheter under fluoroscopic control and occluding the aneurysm with a stent (Roszelle BN, Nair P, Gonzalez LF, Haithem Babiker M, Ryan J, Frakes D. Comparison among different high porosity stent configurations: hemodynamic effects of treatment in a large cerebral aneurysm. J Biomech Eng. 2014 Feb;136 (2): 021013). However, when this known method is performed, while positioning the catheter in the correct manner and identifying the defect, the surrounding blood flow may be neglected, and heavy bleeding from the aneurysmal cavity may continue. Therefore, existing analogues differ from the claimed technology.

[0024] Known in the art are methods for detecting hollow organ injuries by administering various colored or radiopaque substances into the hollow organ (Ozimok CJ, Mellnick VM, Patlas MN. An international survey to assess use of oral and rectal contrast in CT protocols for penetrating torso trauma. Emerg Radiol. 2019 Apr;26 (2): 117-121; Broder JS, Hamedani AG, Liu SW, Emerman CL. Emergency department contrast practices for abdominal / pelvic computed tomography—a national survey and comparison with the American College of Radiology appropriateness criteria (J Emerg Med. 2013 Feb;44 (2): 423-33). However, the procedure itself only allows the identification of the lesion, which is not always possible, since the success of the identification of the lesion strongly depends on the location of the lesion and the characteristics of the substance administered. In other words, this known method does not always allow the precise localization of the lesion in the hollow organ and does not allow the treatment of this lesion.

[0025] A similar catheter for isolating a region of a hollow organ of a mammal is disclosed in U.S. Patent No. 9,526,874, published June 30, 2015. The catheter disclosed in U.S. Patent No. 9,526,874 comprises an elongate body designed to be inserted into the lumen of the hollow organ of a mammal, and two balloons configured to be inflated to isolate the interior of the hollow organ of the mammal therebetween, with a functional channel extending within the catheter body and a functional opening provided in the catheter body between the balloons, the functional channel being designed to create a negative pressure in the isolated interior to allow for the withdrawal of biological fluids specific to the hollow organ or the supply of a liquid or gaseous medium to the isolated interior.

[0026] A disadvantage of the catheter disclosed in U.S. Pat. No. 9,526,874 is that it cannot be inserted into the lumen of a hollow organ for extended periods of time due to the lack of physiological connectivity between the region of the hollow organ isolated by the inflated balloon and adjacent portions of the hollow organ outside that region.

[0027] Other similar catheters for isolating the interior of hollow mammalian organs are disclosed in U.S. Pat. No. 4,781,677, published November 1, 1988; U.S. Pat. No. 5,460,610, published October 24, 1995; International Publication No. 2018106788, published June 14, 2018; U.S. Pat. No. 5,951,514, published September 14, 1999; and U.S. Pat. No. 5,222,941, published June 29, 1993.

[0028] A major drawback of the catheters disclosed in U.S. Pat. No. 478,167, U.S. Pat. No. 5,460,610, WO 2018106788, or U.S. Pat. No. 5,222,941 is that the functional openings in the catheter body are quickly blocked or occluded by tissue in the hollow organ and / or material associated with the catheter body or structural components of the catheter, preventing the catheter from being used in the hollow organ for extended periods of time, which may result in damage to the mammalian hollow organ.

[0029] The closest prior art to the present invention is the catheter disclosed in U.S. Patent No. 5,951,514 (IPC: A61M 29 / 00; publication date: September 14, 1999). The catheter disclosed in U.S. Patent No. 5,951,514 has the same drawbacks as the catheters disclosed in U.S. Patent No. 478,167, U.S. Patent No. 5,460,610, WO 2018106788, and U.S. Patent No. 5,222,941.

[0030] Therefore, catheters and systems for isolating the interior of hollow mammalian organs need to be further developed, particularly to prevent the functional openings in the catheter body from becoming blocked or occluded by tissue of the hollow organ, and thus to prevent damage to the hollow mammalian organ when the catheter is used within the hollow mammalian organ.

[0031] Therefore, the main technical problem to be solved by the present invention is to develop a catheter and system for isolating the interior of a hollow organ of a mammal, which will at least partially overcome the above-mentioned drawbacks of the prior art, i.e., eliminate the problem of blockage or embolization of functional openings by tissue of the hollow organ, which may cause damage to the hollow organ of a mammal during use of the catheter. Summary of the Invention

[0032] The object of the present invention is to develop a catheter and system for isolating the interior of a hollow mammalian organ that solves at least the major technical problems mentioned above.

[0033] To achieve the objectives of the present invention, as embodied and broadly described herein, in a first aspect of the present invention there is provided a catheter for isolating the interior of a hollow organ of a mammal, the catheter comprising: (i) an elongated catheter body designed to be inserted into a lumen of the hollow organ of a mammal; (ii) two balloons arranged separately along the catheter body and each designed to be inflated to isolate the interior of the hollow organ of a mammal; and (iii) a functional channel extending within the catheter body, the functional channel having a functional opening in the catheter body between the balloons, the functional channel designed to generate a negative pressure in the isolated interior and obtain a liquid or gaseous medium through the functional opening; and further, the catheter body has a ring-shaped protrusion between the balloons surrounding the functional opening, the functional opening being configured to be located between the ring-shaped protrusions, the ring-shaped protrusions designed to maintain a distance between the functional opening and a mucosal tissue of the hollow organ of a mammal located between the inflated balloons when a negative pressure is generated.

[0034] The main technical effect of the catheter for isolating the interior of a hollow organ of a mammal in the first aspect of the present invention is to prevent the tissue of the hollow organ of a mammal from being sucked into the functional opening of the catheter body, thereby eliminating the possibility of causing damage to the tissue of the hollow organ and improving the safety of the catheter. In particular, in the first aspect of the present invention, the ring-shaped protrusion surrounds the functional opening provided in the catheter body, thereby preventing the tissue of the hollow organ from being sucked into the functional opening. That is, in the present invention in the first aspect of the present invention, even if negative pressure is generated in the isolated interior defined by the balloon, the ring-shaped protrusion does not allow the tissue of the hollow organ to come into direct contact with the functional opening or to approach close enough to be sucked into the functional opening.

[0035] Another technical effect provided by the catheter for isolating the interior of a hollow organ of a mammal in the first aspect of the present invention is that it improves the reliability of the catheter by preventing partial or complete occlusion or blockage that may be caused by tissue of the hollow organ of the mammal being sucked into the functional opening (the suction of the tissue of the hollow organ into the functional opening is further prevented by the ring-shaped protrusion provided on the catheter body that surrounds the functional opening), thereby preventing the need to remove the catheter from the hollow organ of the mammal and replace it with a new catheter, or remove the tissue of the hollow organ that has entered the functional opening through the functional opening of the removed catheter.

[0036] Furthermore, the catheter according to the first aspect of the present invention provides a new technical effect in that it has improved usability. The catheter according to the first aspect of the present invention provides a new technical effect because the ring-shaped convex portion surrounding the functional opening is arranged between the balloons. In particular, the usability of the catheter is improved because the possibilities for generating a controlled negative pressure in the isolated interior of a hollow organ are essentially expanded. This negative pressure has a level required to provide suction or to supply a liquid or gaseous medium to the isolated interior space with a required dose or volume specific to mammalian hollow organs with different physiological characteristics or diseases. Such expanded possibilities are conditioned by the increased volume of the isolated interior space in the mammalian hollow organ, which can be used to generate a controlled negative pressure therein and supply a liquid or gaseous medium.

[0037] Furthermore, the catheter according to the first aspect of the present invention provides the novel technical effect of properly centering the functional opening relative to a target region of a hollow organ in a mammal, from which a liquid or gaseous medium is to be aspirated or delivered to the region. In particular, the catheter according to the first aspect of the present invention provides a novel technical effect due to the ring-shaped protrusions that surround the functional opening and are disposed between the balloons.

[0038] In one embodiment of the first aspect of the present invention, the functional opening may be further covered by a net or enclosure that is permeable to liquid and / or gaseous media.

[0039] The use of a net or enclosure for covering the functional opening of the catheter in the first aspect of the present invention contributes to the above-mentioned technical effects of improving the safety and reliability of the catheter, particularly by preventing tissue of the hollow organ from being sucked into the functional opening of the catheter body.

[0040] In another embodiment of the first aspect of the present invention, a net or enclosure is disposed to at least partially surround a portion of the catheter body defined by the balloon and is configured to cover the functional opening.

[0041] The use of a net or enclosure to cover the functional opening of the catheter in the first aspect of the present invention further promotes the above-mentioned technical effects of improving the safety and reliability of the catheter, particularly by preventing tissue from hollow mammalian organs from being sucked into the functional opening of the catheter body.

[0042] In another embodiment of the first aspect of the invention, the net or enclosure is secured to the balloon and configured such that the net or enclosure is under tension when the balloon is inflated.

[0043] The use of a net or enclosure in a catheter according to the first aspect of the present invention, which is secured to a balloon and configured to tension the net or enclosure when the balloon is inflated, contributes to the above-mentioned technical effects (improved safety and reliability of the catheter), particularly by preventing tissue of a mammalian hollow organ from being sucked into the functional opening of the catheter body.

[0044] According to another embodiment of the first aspect of the invention, the net or enclosure is configured to surround the balloon and is configured such that the net or enclosure is under tension when the balloon is inflated.

[0045] In the use of a net or enclosure in a catheter in the first aspect of the present invention, the net or enclosure arranged to surround the balloon is configured so that tension is applied to the net or enclosure when the balloon is inflated, thereby contributing to the technical effect of improving the safety and reliability of the catheter, particularly by preventing tissue of a hollow organ from being sucked into the functional opening of the catheter.

[0046] In some embodiments of the first aspect of the present invention, the net or enclosure is further secured to a ring-shaped protrusion.

[0047] The use of a net or enclosure in the catheter in the first aspect of the present invention, which is further fixed to the ring-shaped protrusion, contributes to the above technical effect of improving the safety and reliability of the catheter, in particular to prevent tissue of the hollow organ from being sucked into the functional opening of the catheter body.

[0048] In some embodiments of the first aspect of the invention, the catheter may further comprise a second channel extending through the catheter body, the second channel having an inlet and an outlet at opposite ends outside the catheter body portion defined by the balloon within the catheter body.

[0049] According to the first aspect of the present invention, the use of a second channel with an inlet and an outlet located outside the catheter body portion defined by the balloon of the catheter provides the further technical effect of preventing or eliminating the formation of congestive and / or inflammatory processes caused by the accumulation of mucus and other biological contents specific to the hollow organ outside the isolated interior space defined by the balloon outside the hollow organ. In particular, the formation of congestive and / or inflammatory processes in the hollow organ is prevented or eliminated because, when mucus and other biological substances specific to the hollow organ accumulate inside the hollow organ, they flow in through the inlet provided in the catheter body located outside the catheter body portion defined by the balloon and flow out through the outlet provided in the catheter body located outside the catheter body portion defined by the balloon.

[0050] To achieve the objects of the present invention, as broadly described by way of example herein, in a second aspect of the present invention there is provided a catheter for isolating the interior of a hollow mammalian organ, the catheter comprising: (i) an elongated catheter body designed to be inserted into the lumen of a hollow mammalian organ; (ii) two balloons disposed separately along the catheter body and each designed to be inflated to isolate the interior of the hollow mammalian organ; and (iii) a functional channel extending through the catheter body and having a functional opening in the catheter body between the balloons, the functional channel designed to create a negative pressure in the isolated interior and to obtain a liquid or gaseous medium via the functional opening. Here, the catheter body comprises a net or enclosure permeable to liquid and / or gaseous media, and the net or enclosure is arranged to at least partially surround a portion of the catheter body defined by the balloon and cover a functional opening, the functional opening being located between two ring-shaped protrusions provided on the catheter body portion defined by the balloon, and the net or enclosure is fixed to or arranged to surround the balloon, and is configured such that tension is applied to the net or enclosure when the balloon is inflated.

[0051] In some embodiments of the second aspect of the invention, the catheter may further comprise a second channel extending within the catheter body, the second channel having an inlet and an outlet at opposite ends within the catheter body located outside the portion of the catheter body defined by the balloon.

[0052] The use of a second channel with an inlet and an outlet located outside the catheter body portion defined by the balloon in the catheter of the second aspect of the invention provides the additional technical effect mentioned above, namely, preventing or eliminating the formation of congestive and / or inflammatory processes caused by the accumulation of mucus and other biological contents typical of hollow organs outside the isolated interior space defined by the balloon.

[0053] To achieve the objects of the present invention, as broadly described by way of example herein, there is provided in a third aspect of the present invention a system for isolating the interior of a hollow organ of a mammal, the system comprising: a catheter for isolating the interior of a hollow organ of a mammal according to any embodiment of the first or second aspect of the present invention; and a functional device connected to a functional channel and enabling the extraction of a liquid or gaseous medium therefrom by negative pressure generated in the isolated interior.

[0054] The catheter according to the second aspect of the invention and the system according to the third aspect of the invention provide the main technical effect mentioned above, which is an improvement in the safety of the catheter, as well as the new technical effect of preventing or eliminating the formation of hemostatic and / or inflammatory processes, improving the convenience of the catheter, and further providing the new technical effect of proper centering of the functional opening relative to the target area of ​​the hollow organ of a mammal.

[0055] In the second and third aspects of the invention, the tissue of the hollow organ is further prevented from being sucked into the functional opening because the net or enclosure in tension covers the functional opening. [Brief explanation of the drawings]

[0056] [Figure 1] 1 is a schematic diagram of a catheter for isolating a region of a mammalian hollow organ, in accordance with the present invention; [Figure 2] 2A and 2B illustrate functional openings provided in a portion of the catheter of FIG. 1. [Figure 3] FIG. 1 is a diagram of a catheter with a grid enclosure in a state where the balloon is deflated or blown out. [Figure 4] FIG. 1 is a diagram of a catheter with a grid enclosure in a state when the balloon is inflated. DETAILED DESCRIPTION OF THE INVENTION

[0057] In the context of this document, unless expressly stated otherwise, the term "patient" refers primarily to a potentially ill human being (a member of the mammalian class) who is seeking medical advice or who remains under medical observation in order to have a disease diagnosed and / or treated. Here, the term "patient" also refers to a potentially ill mammalian animal who remains under medical observation in order to have a disease diagnosed and / or treated for the "patient."

[0058] Furthermore, in the context of this document, unless expressly stated otherwise, the term "mammal" refers to humans or animals, particularly non-human primates of the ape kind, dogs, cats, horses, camels, donkeys, cows, sheep, pigs, and other known mammals.

[0059] Furthermore, in the context of this document, unless expressly stated otherwise, the term "user" refers to any suitably skilled healthcare professional authorized to insert a catheter according to the present invention into a hollow organ of a mammal (particularly a human hollow organ), to remove a catheter according to the present invention from a hollow organ of a mammal, and / or to manipulate a catheter according to the present invention inserted into a hollow organ of a mammal, where the healthcare professional may be, for example, a surgeon, an oncologist, an endoscopist, a thoracic surgeon, a vascular surgeon, a urologist, a veterinarian, etc.

[0060] Currently, the most advanced method for diagnosing and / or treating inflammatory, autoimmune, infectious, benign, and / or malignant diseases occurring in hollow organs or mammalian organs connected thereto, particularly diseases of the pancreas, bile duct, liver, and gastrointestinal tract, as well as diseases and injuries of mammalian hollow organs, diverticular dilatation associated with hollow organ fistulas, stenoses, aneurysms, and / or other diseases, is liquid biopsy, which is based on the determination of disease-specific characteristics of an organism's biological fluids or biological fluids that are specific to the hollow organ or to the mammalian organs connected thereto. Specifically, liquid biopsies used to diagnose and / or treat mammalian pancreatic cancer and precancerous transitions at an early stage are based on the detection of circulating disease-related cells, circulating tumor DNA, RNA, proteins, peptides, metabolites, and circulating tumor exosomes in the biological fluids (e.g., blood and pancreatic juice) of the mammalian organism.

[0061] One important aspect of liquid biopsy is the amount of sampled material, thereby requiring a sufficient amount of sampled material to perform a diagnosis. Another important aspect of liquid biopsy is the localization of disease, particularly tumor localization, within a mammalian organism, because the disease-related genetic or other diagnostic material isolated from the sample may be representative of cancers of various hollow organs or mammalian organs associated with those organs.

[0062] Specifically, for the reasons stated above, pancreatic juice is the most suitable diagnostic fluid for use in detecting circulating tumor cells, DNA, RNA, proteins, peptides, metabolites, and exosomes therein to diagnose cancer, pancreatic mucinous, and intraepithelial neoplasms. However, sampling pancreatic juice presents a most challenging problem, which is effectively solved by a catheter 100 according to any one of the following embodiments of the present invention. The structural and design features and functionality of the catheter 100 according to the present invention are described in more detail below in the context of solving the illustrative task of collecting pancreatic juice from the duodenal papilla, but the scope of the present invention is not limited thereby.

[0063] It should be noted that the minor and major duodenal papillae (also called the papilla of Santorini and the papilla of Fateri, respectively) each represent an anatomical structure in the form of a hemispherical, conical, or flattened protuberance located at the end of a longitudinal fold of the mucosa in the middle of the descending portion of the duodenum, specifically, approximately 12 to 14 cm below the pylorus. In many cases, a single opening common to the bile and pancreatic ducts is exposed to the duodenal lumen, while in other cases, the pancreatic duct is exposed 2 to 4 cm above the duodenal papilla. The ampulla of the hepatopancreatic duct is located within the duodenal papilla, and this ampulla is used to receive bile and digestive juices from the pancreas. It also contains the sphincter of Oddi, which controls the flow of bile or pancreatic juice into the duodenum and prevents intestinal contents from entering the bile and pancreatic ducts. Thus, in mammalian duodenum, the major duodenal papilla is usually 12 to 14 cm below the pylorus, and the minor duodenal papilla is 2 to 4 cm above the major duodenal papilla.

[0064] Specifically, a physiological negative pressure of 40 to 100 mmH2O must be created around the papilla of Fateri or the major duodenal papilla to allow pancreatic juice to flow into the duodenal lumen. This is usually achieved by duodenal peristalsis (Physiology of Digestion. S. Teesalu. 1987. Tartu. Tartu State University, p. 84; The Pancreas. Third Edition. 2018. Blackwell. UK. 1300). Another criterion is the need for isolated sampling of pancreatic juice containing inactive digestive enzymes, free from gastric and duodenal fluid and contents. This is because the presence of gastric and duodenal fluid and contents can activate enzymes and digest cells, DNA, RNA, proteins, peptides, metabolites, and exosomes, which are necessary for diagnosis.

[0065] 1-4 schematically illustrate a catheter 100 for isolating a region in a hollow organ according to the present invention. Here, the catheter 100 is a catheter inserted into the lumen of the hollow organ by a user. The housing or body of the catheter 100 is formed as a flexible hollow tube having dimensions, specifically, length and thickness, suitable for user-assisted insertion or advancement of the catheter to a placement location within the lumen of the hollow organ. The user operating the catheter 100 may be a healthcare professional of appropriate skill, such as a surgeon, oncologist, endoscopist, thoracic surgeon, vascular surgeon, urologist, veterinarian, or the like. The catheter 100 for isolating a region in a hollow organ may be used for any patient, specifically, any human or animal.

[0066] The catheter 100 of Figure 1 has an axial opening 11 at its distal end, which is used to administer or insert the catheter 100 into a patient and then advance the catheter 100 to a location within the lumen of the patient's hollow organ, specifically, the cavities associated with the digestive tract, bile duct, respiratory tract, urinary system, patient's duct, uterus, and vagina. Additionally, the catheter 100 is fitted with a three-way connector 12 at its proximal end opposite the distal end, which is located outside the patient's body when the catheter 100 is inserted into the lumen of the patient's hollow organ. Specifically, when the catheter 100 is used to isolate a region of the duodenum of a patient, the catheter 100 is administered or inserted into the patient's nasal passage with its distal end, and then the inserted catheter 100 is advanced along the patient's duodenum to a location within the patient's duodenum.

[0067] As shown in FIG. 1, the three-way connector 12 in the catheter 100 may be a pipe or tube provided with three branches or terminals: a central terminal 9 and two side terminals 8 and 10 sealed and isolated from the central terminal 9, where each of the terminals 8, 9, 10 has a corresponding opening at its free end and is configured to connect to or couple with an appropriate functional instrument or device.

[0068] Central terminal 9, located between side terminals 8 and 10 within three-way connector 12, is configured to connect to or couple to an appropriate (first) functional appliance or device, where the first functional device may be any device known in the art for delivering a gaseous medium or fluid (not shown), e.g., an enteral nutritional mixture. The device for delivering a gaseous medium or fluid connected to central terminal 9 may be, for example, a syringe filled with an enteral nutritional mixture, a medical dropper filled with an enteral nutritional mixture, or other devices and appliances, including automated or semi-automated ones, suitable for connecting central terminal 9 and delivering a gaseous medium or fluid, e.g., an enteral nutritional mixture, to central terminal 9 to provide basic nutrients, energy, vitamins, macronutrients, micronutrients, and / or other nutrients to the patient's organism. Thus, a device for supplying a gaseous medium or fluid connected or attached to the central terminal 9 may be used, for example, to provide nutritional support or clinical nutritional support to a patient when the catheter 100 is inserted into the lumen of the duodenum (or other portion of the digestive tract). Additionally, a device for supplying a liquid or gaseous medium when connected or attached to the central terminal 9 may be used, for example, to sanitize the stomach and duodenum of a patient.

[0069] One of the two side terminals, side terminal 8, of three-way connector 12 is designed to connect or attach a suitable (second) functional instrument or device to the side terminal, which may be implemented as, for example, a medical inhalation apparatus, suction device, or aspirator (not shown) comprising a storage reservoir or container (not shown) for collecting biological gaseous media, biological liquids, and / or biological fluids, and an air compressor for aspirating or drawing out air or another suitable gaseous media. The pressure for aspirating or drawing out air or another suitable gaseous media may be adjusted by a person skilled in the art for the corresponding hollow organ based on information disclosed in prior art documents, e.g., U.S. Pat. No. 6,712,798.

[0070] Furthermore, the second functional device attached to the side terminal 8 within the three-way connector 12 may be formed as a specialized device or a device for supplying a gaseous medium or fluid (e.g., a medical product), such as a syringe filled with the liquid to be supplied, or a medical dropper filled with the liquid to be supplied, or any other device or instrument, including automated or semi-automated ones, suitable for connecting the side terminal 8 and supplying said gaseous medium or fluid to the side terminal 8.

[0071] The other side terminal 10 of the three-way connector 12 is configured to connect or attach a suitable (third) functional instrument or device to that side terminal, which may be embodied as a specialized device or a device (not shown) for supplying a liquid or gaseous medium under pressure, such as water or air, in particular a syringe filled with the liquid or gaseous medium to be supplied (e.g., water or air), or a medical dropper filled with the liquid to be supplied (e.g., water), or any other device or instrument suitable for connecting the side terminal 10 or supplying a fluid or gaseous medium to the side terminal 10, including automated or semi-automated devices or instruments.

[0072] It should be noted that the above-described first functional device (not shown), connectable to the central terminal 9 of the catheter 100 for supplying a liquid, e.g., an enteral nutritional mixture, the above-described second functional device (not shown), connectable to the side terminal 8 of the catheter 100 for sampling a biological fluid or biological gaseous medium or for supplying a liquid or gaseous medium, and / or a third functional device (not shown), connectable to the side terminal 10 of the catheter 100 for supplying a liquid, e.g., water, in combination with the catheter 100 shown in FIGS. 1-4 , may form a system for isolating a region within a hollow organ of a mammal (not shown). These may be used to sample a biological fluid or biological gaseous medium (e.g., a biological liquid) that is specific to a particular hollow organ of a mammal, or may constitute a corresponding part of such a system. Specifically, the above-described system may be used to isolate a region within the duodenum of a mammal for sampling pancreatic juice and / or bile.

[0073] 1-4, the body of the catheter 100 is provided with two isolation balloons 4 on its exterior, each formed as an expanding or inflating soft reservoir, where the isolation balloons 4 are spaced a predetermined distance from each other and from the distal end of the catheter 100. A functional orifice or opening 7 is provided between the isolation balloons 4 within the body of the catheter 100. When the catheter 100 is inserted into the lumen of a patient's hollow organ, one of the isolation balloons 4, i.e., the one furthest from the distal end of the catheter 100, will be positioned further than the area of ​​interest within the hollow organ, and the other isolation balloon 4 will be isolated to the area of ​​interest within the hollow organ. Here, the functional opening 7 is opposite or adjacent to the problem area, for example, opposite or adjacent to one of the smaller and larger duodenums, between the smaller and larger duodenums, opposite or adjacent to an intestinal fistula, opposite or adjacent to a wall lesion, opposite or adjacent to a tumor, etc.

[0074] Furthermore, the catheter 100 for isolating a region within a hollow organ comprises three separate functional channels disposed in the elongate body of the catheter 100: a main channel 1; supply channels 2 for supplying a liquid or gaseous medium to the isolation balloons 4, the supply channels 2 being sealingly isolated from the main channel 1 and disposed in the catheter body 100, each having a hole opening to the interior of a corresponding one of the isolation balloons 4; and functional channels 3 separated from the supply channel 2 and sealingly isolated from the main channel 1. The supply channels 2 and the functional channels 3 extend within a portion of the main channel 1 along its length.

[0075] A main channel 1, which extends substantially along the entire length of the catheter 100, communicates with the central terminal 9 of the three-way connector 12, and has an entrance hole or inlet at the proximal end of the catheter 100 corresponding to the opening in the central terminal 9, and an exit hole or outlet at the distal end of the catheter 100 corresponding to the axial bore 11. When the catheter 100 is inserted into the lumen of a hollow organ of a patient, the entrance of the main channel 1 is located outside the patient's body so as to communicate with the surrounding atmosphere or environment, and the outlet of the main channel 1 communicates with the lumen of the organ, such as the esophagus, stomach and duodenum, the small intestine or the large intestine, as well as the airway, bile duct, urinary tract, tubes, etc. Thus, in the case where the above-mentioned first functional device (not shown) is connected to the central terminal 9 of the three-way connector 12, a medical product, in particular an enteral or parenteral nutritional mixture, may first be supplied under pressure from the first functional device to the central terminal 9 through a hole formed therein, then from the central terminal 9 to the main channel 1, and finally from the main channel 1 to the interior of the hollow organ through the axial hole 11 shown in Figure 1.

[0076] A supply channel 2, which extends substantially along a portion of the length of the catheter 100, communicates with each of the isolation balloons 4 through one of corresponding outlets 13, 14 provided in the body of the catheter 100 (as shown in FIG. 2) and with the side terminal 10 of the three-way connector 12, where the supply channel 2 has an entry hole or inlet corresponding to an opening provided in the side terminal 10 at the proximal end of the catheter 100. When the catheter 100 is inserted into the lumen of a hollow organ of a patient, the inlet of the supply channel 2 is located outside the patient's body so as to communicate with the surrounding atmosphere or environment. Thus, in the case where the above-mentioned second functional device (not shown) is connected to the side terminal 10 of the three-way connector 12, a given volume of gaseous medium or fluid, e.g., air or water, may first be supplied under pressure from the second functional device to the side terminal 10 through holes formed therein, then from the side terminal 10 to the supply channel 2, and finally from the supply channel 2 to both isolation balloons 4 through corresponding holes formed in the catheter body 100. The isolation balloons 4 are thereby inflated or filled with water or gas, specifically using the supply channel 2 of the catheter 100, to provide balloons 4 each having a collectively filled or inflated size or volume. For any particular hollow organ, the pressure used to fill or inflate the isolation balloons 4 with fluid or gas may be selected by one skilled in the art based on information disclosed in prior art documents, e.g., U.S. Pat. No. 7,722,568.

[0077] It should be noted that an increase in the size or volume of the isolation balloon 4 may result in bidirectional occlusion or blocking of the lumen of the patient's hollow organ into which the catheter 100 is inserted, e.g., the lumen of the patient's duodenum, thereby allowing a portion of the catheter 100 having a functional opening 7 to be isolated within the patient's hollow organ between the inflated isolation balloons 4. The inflated isolation balloons 4 thus allow sections of the patient's hollow organ, e.g., the greater and lesser duodenal papillae, aneurysms, hollow organ wall defects, etc., to be isolated from proximal and distal sections of the hollow organ. They thus exclude or prevent the target biological fluid from mixing with other biological fluids, and allow the catheter 100 to be secured within the lumen of the patient's hollow organ, e.g., the lumen of the patient's duodenum, due to the exterior of the balloon 4 closely adjacent to the inner wall surface of the hollow organ. Specifically, in the case where catheter 100 is inserted into the lumen of the duodenum, the inflated isolation balloon 4 can isolate the minor and / or major duodenal papilla of the patient's duodenum from the proximal and distal sections of the digestive tract, thus preventing mixing of the target biological fluid, which may be a mixture of pancreatic juice and bile with other biological fluids, such as gastric juice and contents and / or duodenal contents. This ensures that digestive enzymes contained in the pancreatic juice remain inactive.

[0078] In one embodiment of the present invention, the isolation balloons 4 may be in communication with one another through the supply channel 2, thereby ensuring uniform redistribution of the liquid or gaseous medium used to expand or inflate the balloons, for example, during the passage of peristaltic waves through the intestine or esophagus. In another embodiment of the present invention, the isolation balloons 4 may be formed, for example, as self-inflating balloons, or balloons inflated by air supplied to the supply channel 2 of the catheter 100 through holes in the side terminal 10 of the three-way connector 12, or balloons inflated by any other method known in the art.

[0079] In one embodiment of the present invention, the side terminal 10 of the three-way connector 12 may optionally be provided with a manually operated shut-off valve (not shown) to prevent backflow or leakage of the gaseous medium or fluid, specifically, gas or water, located within the isolation balloon 4, supply channel 2, and side terminal 10. It is further noted that the isolation valve may be used by the catheter user to adjust the degree of inflation of the isolation balloon 4, where the user may visually control the degree of inflation by using an endoscope. Specifically, the user may reduce the size or volume of the inflated isolation balloon 4 by manually opening a check valve to vent or release the gaseous medium or fluid, specifically, gas or water, from the supply channel 4.

[0080] A functional channel 3, extending substantially along a portion of the length of the catheter 100, communicates with the side terminal 8 of the three-way connector 12, with the functional channel 3 having an inlet or inlet port corresponding to the functional opening 7 and an outlet or outlet port corresponding to an opening provided in the side terminal 8 at the proximal end of the catheter 100. Thus, in the case where the above-mentioned third functional device (not shown), embodied as a suction device, is connected to the side terminal 8 of the three-way connector 12, the functional channel 3 acts substantially as a suction channel and the functional opening acts substantially as a suction opening, in which negative air pressure or negative air medium pressure is provided or supported inside the hollow organ, the inside of which is isolated by the inflated isolation balloon 4, as described above. The negative pressure (also referred to in the art as technical vacuum) created in the isolated interior of the patient's hollow organ facilitates the suction or removal of biological gaseous media or biological fluids, in particular biological liquids such as bile and pancreatic juice or pancreatic secretions or pus, or blood, or bronchial secretions, by first suctioning said gaseous media or fluids from the isolated interior into functional channel 3 through functional opening 7, then from functional channel 3 to side terminal 8, and finally from side terminal 8 to a storage container of the suction machine through corresponding holes formed in side terminal 8. It should be noted that the functional channel 3 with the functional opening 7 may be used not only for sampling biological gaseous media or biological fluids specific to a particular hollow organ, but also for supplying the required fluid or gaseous media, for example a medicine in liquid or gas form or a coloring medium, to the isolated interior in case the above-mentioned third functional device (not shown) is implemented as a device for supplying gaseous media or fluids, for example a medical syringe or a medical dropper, and is connected to the side terminal 8 of the three-way connector 12.

[0081] It should be noted that the aspirator, which is one possible embodiment of the third functional device described above and connectable to the side terminal 8 of the three-way connector 12, activates an air compressor that is part of the aspirator when activated by a user. The activated air compressor provides suction or extraction of air media or air from the interior of the patient's hollow organ, e.g., the interior of the patient's duodenum, isolated by the isolation balloon 4 inflated in the manner described above, and from available space within the aspirator's storage container. This available space is not filled with biological gaseous media or biological fluids (e.g., biological fluids such as bile and pancreatic juice or pancreatic secretions) so as to create negative pressure in the isolated interior of the hollow organ, e.g., the lumen of the patient's duodenum. The biological media is thereby acquired through the functional opening 7, and the acquired biological media is removed or supplied to the storage container via the functional channel 3 for accumulation or collection therein for a predetermined period of time.

[0082] It should be noted that in one embodiment, the side terminal 8 of the three-way connector 12 may be used to administer a liquid or gaseous substance carried by the functional channel 3 through this terminal and into the interior between the isolation balloons 4 through the functional openings 7. The administered gaseous or liquid substance, for example a drug or a coloring medium, affects the area of ​​the hollow organ isolated by the balloons 4 and has a diagnostic and / or therapeutic effect on that area.

[0083] In one embodiment of the present invention, the catheter body 100 may be provided with only the isolation balloon 4 communicating with the side terminal 10 and the supply channel 2 described above for supplying a fluid (e.g., water) to the functional channel 3 communicating with the side terminal 8 described above.

[0084] Additionally, the body of catheter 100 is provided on its exterior with two generally identical protrusions 6, each formed as a ring-like protrusion or ring having a radius that is either greater than the radius of the body of catheter 100 or less than the radius of either of the inflated isolation balloons 4. Each of the protrusions 6 is located along the length of the body of catheter 100 on one side of the functional opening 7, adjacent or near the protrusion 6, and the protrusions 6 are preferably evenly spaced apart between the isolation balloons 4 and with respect to the functional opening 7. It should be noted that in the case where the catheter 100 is inserted into the lumen of a hollow organ of a patient, the protrusions 6, which essentially act as protruding sides closing the functional opening 7, prevent the functional opening 7 from coming into contact with the mucosa of the patient's hollow organ or from approaching a distance appropriate for aspirating mucosal tissue into the functional opening 7 when a suction device connected to the functional channel 3 of the catheter 100 is activated by the user, thus providing a negative pressure in the isolated interior of the lumen of the hollow organ by the suction device, which would damage the mucosal tissue of the hollow organ. In one embodiment of the present invention, the protrusions 6 may have any other shape different from a ring or ring-shaped shape, provided that this shape prevents the functional opening 7 from coming into contact with the mucosa of the patient's hollow organ or from approaching a distance appropriate for aspirating mucosal tissue into the functional opening 7 when a negative pressure is generated in the isolated interior of the hollow organ in communication with the functional opening 7.

[0085] 3 and 4, the body of the catheter 100 is provided on its exterior with two projections or protrusions 15, each of which is provided on the exterior of the catheter body portion defined by the isolation balloons 4 at a predetermined distance from a corresponding one of the balloons 4, and an elastic net or grid enclosure 16 is attached to the projections 15 to completely or at least partially cover both the isolation balloons 4 and the portion of the body of the catheter 100 defined by the balloons 4, thereby completely or at least partially containing or covering the functional opening 7. When the balloons 4 are inflated, the grid enclosure 16 is pulled or stretched, as shown in FIG. 4, thereby moving or displacing the interior wall tissue within the hollow organ a predetermined distance from the functional opening 7. The grid enclosure 16 in its completely or at least partially pulled state forms an elastic outer casing or frame. This elastic outer casing or frame completely or at least partially closes the catheter body portion defined by or located between balloons 4, thereby completely or at least partially containing or covering functional opening 7. The outer frame formed by grid enclosure 16 has a cylindrical shape and, due to its open structure, is extrudable by liquids, thereby allowing the specific biological fluids of certain hollow mammalian organs to extrude or pass through the material of grid enclosure 16 and into functional opening 7. Specifically, in the case where a suction device (not shown) is connected to the side terminal 8 to provide negative pressure to the isolated area between the isolation balloon 4 through the functional channels 3 and functional openings 7 of the catheter 100, the stretched or tensioned grid enclosure 16 prevents the inner wall tissue within the hollow organ (e.g., duct walls, intestinal mucosa, bronchi, stomach, ureters, or others) from adhering or attaching to the functional openings 7, thereby allowing the continuous suction of biological materials or biological fluids, such as bile, pancreatic juice, bronchial secretions, etc., into the container of the suction device.

[0086] In one embodiment of the present invention, a grid enclosure 16 may be attached to both of the isolation balloons 4 such that the grid enclosure 16 completely or at least partially surrounds the portion of the catheter body defined by or located between the balloons 4, thereby completely or at least partially encompassing or covering the functional opening 7. When the balloons 4 are inflated, the grid enclosure 16 will be pulled or stretched, as shown in FIG. 4 , thereby allowing the interior wall tissue within the hollow organ to be removed or offset a predetermined distance from the functional opening 7.

[0087] In another embodiment of the present invention, the grid enclosure 16 may be formed as a net-like material or net that is preliminarily fixed in a tensioned or at least partially tensioned state over the protrusions 6, such that the grid enclosure 16 completely or at least partially surrounds the catheter body portion defined by or located between the balloons 4, thereby completely or at least partially containing or covering the functional openings 7.

[0088] In some other embodiments of the present invention, the grid enclosure 16 may be secured in a pre-tensioned state on the body of the catheter 100 by any suitable fastening means known in the art, such that the grid enclosure 16 completely or at least partially surrounds the portion of the catheter body defined by or located between the balloons 4, thereby completely or at least partially containing or covering the functional opening 7.

[0089] In other embodiments of the present invention, the grid enclosure 16 may have any configuration that allows the grid enclosure 16 to be secured onto the body of the catheter 100, onto the protrusion 6, or onto the isolation balloon 4 to completely or at least partially close or cover the functional opening 7.

[0090] Additionally, three auxiliary holes 5.1, 5.2 are provided in the catheter body 100 outside the isolation balloon 4 and thus outside the portion of the catheter body in which the functional opening 7 is provided and defined by the isolation balloon 4. When the catheter 100 is inserted into the lumen of a patient's hollow organ, the auxiliary holes 5.2 located away from the distal end of the catheter 100 act as inlets, and the auxiliary holes 5.1 located near the distal end of the catheter 100 act as outlets. It should be noted that the auxiliary holes 5.1, 5.2 allow the contents of the hollow organ, for example, air, urine, blood, stomach or intestinal contents along with inactive digestive enzymes, to pass to the distal section of the hollow organ without entering the area defined by the inflated isolation balloon 4 of the catheter 100, thereby preventing or eliminating the formation of hyperemic and / or inflammatory processes within the patient's hollow organ, which are caused in particular by the accumulation of blood, urine, air, mucus, and other contents within the patient's hollow organ outside the inflated isolation balloon 4 located away from the distal end of the catheter 100 or located furthest away.

[0091] Depending on the application of the catheter 100 of the present invention and the anatomical parameters of the hollow organ, the length and diameter of the catheter 100, the wall thickness of the catheter 100, the location and diameter of the isolation balloon 4 within the catheter 100, and the location of the holes may vary. One skilled in the art may readily adjust any of the parameters of the catheter 100 depending on the dimensions of a particular hollow organ.

[0092] The thickness of the channel of the catheter 100 and the size of the isolation balloon 4 may be adjusted by one skilled in the art based on information disclosed in the art, such as U.S. Pat. Nos. 9,526,874, 6,692,465, 5,843,050, 5,919,163, International Publication No. WO 2009 / 035581, 5,397,305, 8,398,589, 7,722,568, 6,712,798, 6,638,245, 1,009,865, and / or other prior art information sources.

[0093] The length of the catheter 100, the distance between the isolation balloons 4, and the distance from the isolation balloon 4 to the distal end may be matched by one skilled in the art based on information disclosed in the art, such as U.S. Pat. No. 5,314,409, U.S. Pat. No. 5,658,264, U.S. Patent Application No. 20150150572, U.S. Pat. No. 5,843,050, U.S. Pat. No. 5,397,305, U.S. Pat. No. 7,070,606, U.S. Pat. No. 6,712,798, U.S. Pat. No. 1,009,865, and / or other prior art information sources.

[0094] For example, in one preferred embodiment of the present invention, catheter 100 may be implemented as a pancreatic digestive catheter and may have a length of 130 cm. In this embodiment of the present invention, isolation balloons 4 are relatively spaced 15 cm and 25 cm from the distal end of catheter 100, which distal end is used to insert catheter 100 into the gastric cavity and duodenal lumen of a patient, such that expanding or inflating isolation balloons 4 enables isolation of an area of ​​duodenum having a length of at least 10 cm. In this embodiment of the present invention, functional opening 7 may be midway between isolation balloons 4, i.e., 5 cm from each of isolation balloons 4 and 20 cm from the distal end of catheter 100.

[0095] The use of the catheter 100 according to the present invention to isolate a region within a hollow organ of a patient has been illustratively described above with reference to the patient's duodenum. However, the use of the catheter 100 is not limited to the patient's duodenum. Accordingly, it will be apparent to one skilled in the art that a catheter 100 according to any of the above-described embodiments can be similarly inserted into the lumen of any other hollow (tubular) organ of a patient, particularly a mammal, such as the esophagus, stomach, duodenum, small intestine, large intestine, airway, urinary tract (genitourinary tract), vein, artery, vagina, uterus, uterine (fallopian) tube, spinal canal, or any suitable internal tubular organ of the patient, where the tubular organ of the patient is associated with a corresponding functional system (organ apparatus) of the mammalian organism from the group of systems including the digestive system, respiratory system, urinary and reproductive systems (also referred to as the genitourinary system or genitourinary system), endocrine system, circulatory system and immune system, and skeletal system.

[0096] Thus, in use, the catheter 100 of the present invention may be inserted by a user into the lumen of a patient's duodenum under the control of an endoscope (not shown) or a direct imaging device (e.g., a fluoroscopy device) so that one of the corresponding isolation balloons 4 furthest from the distal end of the catheter 100 is located at the patient's duodenal valve, where the endoscope may be manipulated by the user or by an endoscopist assisting the user. In particular, it should be noted that the processes of inserting the catheter 100 into the lumen of the patient's duodenum, removing the catheter 100 from the lumen of the patient's duodenum after sampling the required amount of biological fluid, and aspiration are atraumatic and independent of the anatomical features of both the patient and the neoplasm. It should be noted that the isolation balloon 4 is in a deflated state when the catheter 100 is inserted into the lumen of the patient's duodenum by the user.

[0097] According to one embodiment, the catheter 100 may be pre-equipped with at least one loop designed to be gripped by a biopsy forceps. To insert the catheter 100 into a desired placement location in the patient's duodenum, the distal end of the catheter 100, well lubricated with Vaseline oil, is administered through the nasal passage and advanced into the gastric cavity. An endoscope is then further administered or advanced parallel to the catheter 100 through the patient's oral cavity and into the gastric cavity, where the loop(s) of the catheter 100 are captured by the endoscopic biopsy forceps. Finally, the captured catheter 100 is guided or advanced together with the endoscope into the patient's duodenum. Thereafter, under the control of the endoscope, one of the corresponding isolation balloons 4 of the catheter 100, which is furthest from the distal end of the catheter 100, is positioned at the patient's duodenal valve.

[0098] According to another embodiment, a metal guide wire may be preliminarily administered or inserted into the main channel 1 of the catheter 100. To insert the catheter 100 into the desired placement location in the patient's duodenum, the distal end of the catheter 100, which has been well lubricated with Vaseline oil, is inserted through the nasal passage and then advanced into the gastric cavity using the metal guide wire of the catheter 100. An endoscope is then inserted or advanced parallel to the catheter 100 through the patient's oral cavity into the gastric cavity, and once the distal end of the catheter 100 is detected, the first ligature is captured with an endoscopic biopsy forceps, and the catheter 100 is pushed into the endoscope by using the captured first ligature to pull up the catheter 100. Thereafter, the endoscope and the catheter 100 pushed against the endoscope are guided through the pylorus into the patient's duodenum, and one of the corresponding isolation balloons 4 of the catheter 100 that is furthest from the distal end of the catheter 100 is positioned within the valve of the patient's duodenum under the control of the endoscope.

[0099] The user then connects or attaches the aforementioned second functional device (not shown) to the side terminal 10 of the three-way connector 12, where the second functional device is intended to supply a liquid or gaseous medium, e.g., gas or water, in a desired amount or volume—specifically, 40 to 70 ml of water—to the supply channel 2 of the catheter 100 to expand and inflate the isolation balloon 4 and bring it into close proximity with the duodenal mucosa, thereby isolating a desired area of ​​the patient's duodenum, including the major and minor duodenal papilla, and specifically preventing stomach contents and / or duodenal contents, along with inactive digestive enzymes, from entering the isolated area. Specifically, experimental results obtained by the inventors indicate that 40 to 70 ml of air is required to fully inflate the isolation balloon 4 to the size required for bidirectional closure or obstruction of the patient's duodenal lumen, where the catheter 100 may be inserted as in the illustrated embodiment.

[0100] The user then couples or connects the aforementioned third functional device (not shown), embodied as a suction device, to the functional channel 3. Here, the suction device is pre-configured for a constant or variable operating mode, providing the required operating pressure depending on the specific task. Activated by the user, the suction device allows air medium or air to be sucked from the isolated interior of the patient's duodenum through the functional opening 7 and the functional channel 3 communicating with this functional opening 7, the isolated interior corresponding to the periampullary zone of the duodenum, thereby generating an internal negative pressure corresponding to the pressure normally generated by duodenal peristalsis, specifically a negative pressure of 40 to 100 mmH2O (9 to 14 kPa). The negative pressure provided to the isolated interior of the patient's duodenum allows biological fluids in the form of pancreatic juice or pancreatic secretions, combined with bile, to be aspirated or withdrawn from the pancreas through the major and minor duodenal papillae, thereby removing the biological fluids from the isolated area of ​​the patient's duodenum through functional opening 7 and functional channel 3 and collecting the fluids in the aspirator's storage container (not shown). In some cases, bile and pancreatic ductal mucosal secretions may also be collected in the container. The mucosal secretions are one of various biological fluids specific to some biological contents, including fluids produced by organisms that enter the duodenum and / or the pancreatic duct as a result of reflux, and the fluids are specific to the human duodenum. The biological fluids collected in the storage container of the functional device (not shown) can then be transported for cytological and / or molecular genetic testing or other analyses to evaluate the morphological and structural characteristics of the pancreatic secretory cellular elements.Cellular elements make it possible to detect or characterize disease processes specific to, for example, ductal neoplasia, neuroendocrine tumors, or pancreatic cancer, to detect neoplasia at an early stage of development, and to perform differential diagnosis between different types of tumors by determining the expression of specific markers (NKX2, S100P, CEA, EFR3A / B, MUC1, MUC2, MUC5, ANXA1, A2, KRT7, MMP7, MMP9, IGFBP3, PSCA, PRSS2, SHh, KRas, TP53, SMAD4, BRCA1, miRNA 21, and miRNA 155).

[0101] Furthermore, after connecting the aspirator to the functional channel 3, or instead of the aspirator, a device for supplying a gaseous medium or fluid (e.g., a syringe or a medical dropper) may be connected to the functional channel 3, allowing the required fluid or gaseous medium, e.g., a drug in liquid or gas form, to be delivered to the isolated interior of the patient's duodenum.

[0102] It should be noted that the catheter 100 of the present invention may be maintained in an inserted state for a sufficiently long period, e.g., up to 7 days (i.e., up to 168 hours), allowing pancreatic secretions to be collected in adequate quantities for reliable identification and demonstration of diseased tumor material, thereby generally improving the efficiency of diagnosis and, therefore, subsequent treatment of pancreatic cancer. Furthermore, the extended sampling improves the likelihood of detecting diseased cells and other biomarkers not only for pancreatic cancer, but also for malignant conditions of the bile duct and liver, including cholangiocarcinoma and / or hepatocellular carcinoma.

[0103] It is further noted that stimulation of pancreatic juice and bile secretion is not necessary when catheter 100 is used, so that the collected biological material has a true biochemical and physiological profile indicative of the true functional state of the contractility of the pancreas, liver, bile ducts, and gallbladder.

[0104] If necessary, the excretory function of the pancreas may be assessed by testing the biochemical composition of the secreted pancreatic fluid collected in the above manner in a storage container (not shown) in combination with bile using the catheter 100 of the present invention.

[0105] Furthermore, the analysis and quantitative analysis of the quality of pancreatic juice and bile makes it possible to assess the true biochemical profile of both the biological substances and the volume of daily secretions, thereby diagnosing the functional condition.

[0106] The catheter 100 according to any one of the above-described embodiments of the present invention may be used to diagnose or monitor the progression of at least one disease selected from the group including gastritis, pancreatitis, pancreatic cancer, cancer of the bile duct, cholangiocarcinoma, hepatocellular carcinoma, cholangitis, cholelithiasis, defects of the wall of a hollow organ, autoimmune hepatitis, infectious hepatitis, aneurysmal or diverticular protrusion of the wall of a hollow organ, bleeding into the hollow organ, stenosis of a hollow organ and nerve and muscle abnormalities of the esophagus, stomach, duodenum, small and large intestine, bile duct, urinary and excretory tract and respiratory tract.

[0107] Furthermore, the catheter 100 according to any one of the above-described embodiments of the present invention may be used to treat at least one disease selected from the group including pancreatitis, cholangitis, gastrointestinal wall defects, duct aneurysms, venous thrombosis, ureteral defects, airway defects, gastrointestinal bleeding, tracheal bleeding, bronchial bleeding, pulmonary bleeding, and uterine bleeding.

[0108] Additionally, the catheter 100 according to any one of the above-described embodiments of the present invention may be used to isolate an area of ​​a vessel when performing a surgical procedure or when performing a surgical operation, particularly with respect to tissue on the inner wall of the vessel.

[0109] Specifically, when catheter 100 is used, a therapeutic or therapeutic effect is achieved by restoring and promoting the suction of bile or pancreatic juice from the corresponding ducts into the duodenum. The pathogenesis of acute inflammatory diseases such as pancreatitis and cholangitis is at least partially caused by a deterioration or disruption of the outflow of pancreatic juice and bile, which is particularly caused by a deteriorated motility (peristalsis) of the duodenum in mammals. Therefore, by using catheter 100, an isolated area of ​​controllable negative pressure (e.g., 40 mmH2O to 100 mmH2O) that provides suction of pancreatic juice and bile from the bile duct can be used to address this medical problem and thus contribute to the treatment of the above-mentioned acute diseases.

[0110] Furthermore, when catheter 100 is used, there is a therapeutic or therapeutic effect achieved by aspirating the contents from the area associated with the defect in the wall of the digestive tract, whereby an isolated area of ​​controllable negative pressure (e.g., 70 mm to 100 mm of water column) allows all of the biological fluid to be aspirated from the area of ​​the defect and solve this medical problem, thus contributing to solving the patient's aforementioned medical problem.

[0111] It will be apparent to those skilled in the art that the catheter 100 of the present invention may be formed from any suitable material based on the information disclosed in the prior art, for example, U.S. Pat. No. 7,722,568 or U.S. Pat. No. 6,638,245, and that the catheter 100 may preferably be formed from a polymeric material.

[0112] Example Example 1. Patient No. 1 was admitted with a girdle pain in the upper abdomen. Blood amylase was 1150 U / L. Ultrasound examination revealed the following: the pancreas had increased in size: the head was 35 mm, the body was 32 mm, and the tail was 21 mm. It was very heterogeneous. The contours were blurred. The parapancreatic tissue was edematous. No fluid was detected. MSCT images corresponded to acute hydropic pancreatitis. The patient began treatment in accordance with the recommendations of the Russian Society of Surgeons. A catheter 100 according to the present invention was inserted into the patient's duodenum for 24 hours, and an active suction method was performed. After 24 hours, the blood amylase level had decreased to 230 U / L, and the pain syndrome was resolved.

[0113] Example No. 2. Patient No. 2 was admitted with a clinical picture of obstructive jaundice. Tests showed an elevated white blood cell count of 14.1 x 10⁻⁹. Total bilirubin was 145 mmol / L, with a direct bilirubin level of 113.2 mmol / L. Blood amylase was 57 U / L, alanine aminotransferase (ALT) was 391 U / L, and aspartate aminotransferase (AST) was 90 U / L. Ultrasound findings were as follows: Multiple stones measuring less than 1.3 cm in diameter were detected in the gallbladder, and the bile duct was dilated to 11 mm. Magnetic resonance imaging (MRI) findings were as follows: A shadow corresponding to a 6 mm stone was detected in the distal section of the common bile duct. Endoscopic retrograde cholangiopancreatography (ERCP) findings were as follows: A single 8 mm stone was identified and removed endoscopically. To prevent acute pancreatitis, a catheter 100 according to the present invention was inserted into the patient's duodenum for 24 hours, and active suction was performed. In the postoperative period, blood amylase levels did not exceed 87 U / L.

[0114] Example No. 3. Patient No. 3 was admitted as usual for examination and treatment. A previously performed MSCT detected the formation of an abnormal object in the pancreas. Endoscopic ultrasound detected the formation of a pancreatic object measuring 2 cm vs. 3 cm in size. Here, fine-needle biopsy was technically impossible. A catheter 100 according to the present invention was inserted into the patient's duodenum to selectively sample pancreatic juice. Adenocarcinoma cells and driver gene mutations, exosomes, and protein markers were detected in the obtained pancreatic juice through cytological and molecular testing.

[0115] Example No. 4. Patient No. 4 was admitted with a diagnosis of obstructive jaundice. MRI revealed a blockage at the level of the confluence of the right and left hepatic ducts of the lungs, corresponding to a type IIA Klatzkin tumor. A catheter 100 for isolating regions of hollow organs according to the present invention was inserted into the patient's duodenum, and active suction was performed. Abnormal cells and markers of malignant neoplasms were detected in the bile obtained by cytological and molecular testing.

[0116] Example 5. Patient No. 5 was diagnosed with chronic pancreatitis. Despite treatment by a gastroenterologist and the prescribed enzyme medication, the patient experienced a loss of body mass, irregular bowel movements, and diarrhea. To assess the functional status of the pancreas, a catheter 100 for isolating a hollow organ region according to the present invention was inserted into the patient's duodenum for 24 hours, and active suction was performed. Biochemical tests performed on the obtained pancreatic juice revealed reduced levels of alpha-amylase and lipase, as well as reduced daily excretion of pancreatic juice and bile. As a result, the dosage of the enzyme medication taken by the patient was increased, and ursodeoxycholic acid medication and bile substitutes were also prescribed.

[0117] Example 6. Patient No. 6 with jaundice was admitted to the town's infectious disease clinic. Physical examination revealed an enlarged liver. Biochemical blood test results showed the following: total bilirubin 329 mmol / L; direct bilirubin 141 mmol / L; ALT 1040 U / L; and AST 804 U / L. Serological analysis of blood for HCV antigen, HBsAg, was negative. A catheter was inserted into the patient to isolate the hollow organ area. 100 ml of bile was obtained as a result of active aspiration. A high copy number of the HCV virus was detected by PCR analysis of the bile.

[0118] Example No. 7. Patient No. 7 was treated at an infectious disease clinic for documented viral hepatitis. After a course of interferon, repeated PCR analysis of blood showed no active viral process. A catheter 100 for isolating the hollow organ area was inserted into the patient. 200 ml of bile was obtained as a result of active aspiration. PCR analysis of the obtained bile showed an active viral process. Consequently, the treatment regimen and duration were changed.

[0119] Example 8. Patient No. 8 was diagnosed with an intestinal fistula and peritonitis. Surgery, sanitization, and drainage of the abdominal cavity were urgently performed. To isolate the defect in the intestinal wall, reduce its contact with the intestinal contents, improve the healing process, and also provide additional physical therapy for the treatment of peritonitis by separating the abdominal cavity from the diseased substrate, a catheter 100 for isolating a region of a hollow organ according to the present invention was inserted into the area of ​​the intestinal injury, with isolation balloons 4 positioned above and below the defect. After inflating the balloons, an isolated area was formed, and a separate channel was connected to an aspiration device to sanitize the area of ​​the intestinal fistula and promote healing of the defect. Enteral nutrition was also administered to the patient through the catheter 100.

[0120] Example 9. Patient No. 9, suffering from abdominal girdle pain, was admitted to the hospital in a critical condition. Based on the results of the examination, the patient was diagnosed with acute pancreatitis, severe and according to the Atlanta classification. At the time of admission, the amylase level was 1320 U / L. A catheter 100 for isolating a hollow organ region according to the present invention was inserted into the patient. Here, the functional channel was connected to a pump to provide a controllable negative pressure, while enteral nutrition and medical products were administered to the patient through the same catheter 100. As a result, the growth pattern of biochemical parameters became positive according to the BISAP scale within 24 hours, and the patient recovered after 7 days.

[0121] Example No. 10. Patient No. 10 was admitted to the hospital in a critical condition with pain in the right hypochondrium, debilitating fever, and periodic yellowing of the skin. An anamnesis revealed that the patient had undergone an endoscopic procedure on the bile duct to remove a stone from the bile duct three months prior to the current admission. An ultrasound MSCT scan revealed no changes in the liver, duct, or the presence of an abscess. To diagnose cholangitis, a catheter 100 was inserted into the patient to isolate the hollow organ area, and 50.0 ml of bile was sampled for cytological examination. Extensive growth of Klebsiella spp. was revealed, and its susceptibility to antimicrobial agents was determined. After the selection of a disease-specific antibiotic treatment, the symptoms of cholangitis resolved, and the patient was released to outpatient care.

[0122] Example 11. Patient No. 11 underwent resection of the sigmoid colon due to the presence of a tumor lesion. During intestinal effusion, a formation was found to have affected all layers of the intestine, with partial lymphadenopathy involving the tissue behind the peritoneum. When the tumor-containing intestine was isolated, a contusion was established with the injured ureter of the left kidney. A urologist was called to the operating room and surgically repaired the ureteral defect. To prevent complications, a catheter 100 according to the present invention, sized to isolate a region of the hollow organ, was administered retrogradely over a guidewire. One balloon was inflated in the pelvic cavity of the left kidney, and the other balloon (the lower balloon) was inflated in the bladder. The functional channel was then connected to an aspiration device to generate a controllable negative pressure. The catheter 100 was removed after 14 days, and the excretory function of the left kidney did not deteriorate. The patient was released to outpatient care.

[0123] Example 12. Patient No. 12 was admitted with massive pulmonary hemorrhage. Bronchoscopy revealed a decaying, bleeding tumor in the right main bronchus. A catheter 100 for isolating a region of a hollow organ according to the present invention was administered to the right bronchus for the purpose of stemming blood flow and maintaining bronchial patency, as well as preventing pulmonary atherectomy. The catheter 100 was inserted so that the tumor was between the balloons, where inflation of the balloons prevented blood from flowing to other parts of the bronchus. To stop the bleeding, a hemostatic agent was administered through the functional channel of the catheter 100. As a result, there was no recurrence of bleeding during a three (3) day observation period. The catheter 100 was then removed. The patient was released to outpatient care after ten (10) days.

[0124] Example 13. Patient No. 13 was admitted to an established mediastinitis clinic on an emergency basis. Examination revealed a defect in the esophagus due to necrosis caused by a piece of meat. To treat the esophagus, a catheter 100 for isolating a region of a hollow organ according to the present invention was inserted. The balloon of the catheter 100 was inflated to isolate the defect. The functional channel was also connected to an inhalation device to provide a controllable negative pressure. The patient was subsequently released to outpatient care after 1.5 months.

[0125] Example 14. Patient No. 14, with headache and general cerebral symptoms, was admitted to the emergency room. A venous contrast-enhanced MSCT scan revealed an aneurysm in the pelvis of the right middle cerebral artery with signs of eruption. The patient was admitted to the angiography operating room, and a catheter 100 for isolating a region of a hollow organ according to the present invention was administered through a femoral approach. The catheter 100 was placed under fluoroscopic control, with the balloon isolating the aneurysmal area, with the functional channel facing the aneurysm. A filling solution was administered through the functional channel to fill the aneurysmal cavity. After the required exposure, the catheter 100 allowed the surrounding blood flow to be maintained. The catheter 100 was then removed. The patient was released from the hospital 21 days later.

[0126] Example 15. Patient No. 15 was routinely admitted for surgical treatment of pancreatic cancer. Examination revealed a tumor in the head affecting the inferior vena cava. To reduce blood loss, a catheter 100 for isolating regions of hollow organs according to the present invention was inserted into the vein. Balloons were inflated above and below the tumor in the head of the pancreas, thereby diverting blood and returning it to the heart. During resection of the gland, a section of the inferior vena cava was resected with an autograft of a saphenous vein from the lower leg. Blood loss was 500 ml. Thus, optimal transient physiological conditions were created for both the patient and the surgeon.

[0127] Example 16. Patient No. 16 underwent surgical treatment for sigmoid colon cancer. During the postoperative period, the patient developed a defect in the colon-colon anastomosis of approximately one-third of the circumference. To treat the colon, a catheter 100 for isolating a region of a hollow organ according to the present invention was inserted retrogradely into the rectum with one balloon of the catheter 100 positioned most proximal to the defect and the other balloon of the catheter 100 positioned most distal to the defect. When the balloon of the catheter 100 was inflated, the defect area was isolated from the rest of the colon. The proximal section of the intestine was flushed with water via the main channel. As a result, the defect closed in three weeks.

[0128] Example 17. Patient No. 17 was admitted for a suspected liver tumor. A catheter 100 for isolating a region of a hollow organ according to the present invention was inserted to perform a liquid biopsy. The area associated with the greater and lesser duodenal papilla was isolated using the balloon of the catheter 100, and bile aspiration was initiated. After the catheter 100 was removed, the bile aspirate was transported for genetic and cytological testing. No disease markers or cells were detected. After bile was collected, the stocking covering the balloon of the catheter 100 was removed and washed with a buffer solution. Water was collected, and after centrifugation, a cell pellet was obtained. Cytological examination of the retrieved cell pellet revealed the presence of hepatocellular carcinoma cells.

[0129] Example No. 18. Patient No. 18 was admitted to the emergency room with uterine bleeding. Colposcopy revealed a decaying cervical cancer. To stop the bleeding, a catheter 100 was inserted into the vaginal and uterine cavities, and the tumor area was isolated by the balloon of the catheter 100. An infusion of a hemostatic agent for the tumor was administered through the functional channel of the catheter 100. The bleeding stopped, and the patient was released from the hospital.

[0130] The catheter 100 described above therefore makes it possible to carry out or perform functional investigations of any hollow organ and to provide appropriate treatment. Furthermore, testing and / or laboratory analysis of biological fluids collected using the catheter 100 allows for the differentiation and diagnosis of inflammatory, benign, and malignant growths, as well as infectious diseases, with high accuracy. By aspirating specific fluids, the catheter 100 allows for the treatment of inflammatory diseases, hemorrhages, and defects in the walls of hollow organs. By creating an isolated area with a bypass function during surgical procedures, it is possible to control the cessation of blood flow and also to perform subsequent surgical manipulations of the ductal site, specifically resections, in plastic surgery. It should be noted that the catheter 100 of the present invention, or the above-described system that may include the catheter 100 for isolating a region of a hollow organ of a mammal (not shown), provides the ability to collect high volumes of biological material in normal physiological and biochemical conditions without additionally stimulating the excretory function of the hollow organ of the organ connected to it, particularly by generating a negative pressure in the isolated area of ​​the hollow organ into whose lumen the catheter 100 is inserted, corresponding to the physiological negative pressure that may be generated, for example, due to intestinal peristalsis.

Claims

1. A catheter (100) for isolating the interior of a hollow organ in a mammal, comprising: an elongate catheter body configured to be inserted into the lumen of the hollow organ; two balloons (4) arranged separately and separately along the catheter body and configured to be inflated to isolate the interior of the hollow organ between them; a functional channel (3) extending within the catheter body and having a functional opening (7) provided within the catheter body between the balloons (4); the functional channel (3) is configured to create a negative pressure in the isolated interior to draw a liquid or gaseous medium from the isolated interior through the functional opening (7); The catheter body between the balloons (4) is further provided with two ring-shaped protrusions (6) surrounding the functional opening (7), such that the functional opening (7) is located between the ring-shaped protrusions (6), and the ring-shaped protrusions (6) are configured to maintain a predetermined distance between the mucosal tissue of the hollow organ located between the inflated balloons (4) and the functional opening (7) when the negative pressure is generated.

2. 2. The catheter (100) of claim 1, wherein the functional opening (7) is further covered by a net or enclosure (16) that is permeable to liquid and / or gaseous media.

3. 3. The catheter (100) of claim 2, wherein the net or enclosure (16) at least partially surrounds the catheter body portion defined by the balloon (4) and covers the functional opening (7).

4. 4. The catheter (100) of claim 3, wherein the net or enclosure (16) is attached to the balloon (4) so ​​that the net or enclosure (16) is in tension when the balloon (4) is inflated.

5. 4. The catheter (100) of claim 3, wherein the net or enclosure (16) surrounds the balloon (4) so ​​that the net or enclosure (16) is in tension when the balloon (4) is inflated.

6. 4. The catheter (100) of claim 3, wherein the net or enclosure (16) is further secured to the ring-shaped protrusion (6).

7. a second channel (1) extending within the catheter body; 2. The catheter (100) of claim 1, wherein the second channel (1) is provided at both ends with an inlet (5.2) and an outlet (5.1) provided within the catheter body outside the catheter body portion defined by the balloon (4).

8. A catheter (100) for isolating the interior of a hollow organ in a mammal, comprising: an elongate catheter body configured to be inserted into the lumen of the hollow organ; two balloons (4) arranged separately and separately along the catheter body and configured to be inflated to isolate the interior of the hollow organ between them; a functional channel (3) extending within the catheter body and having a functional opening (7) provided within the catheter body between the balloons (4); the functional channel (3) is configured to create a negative pressure in the isolated interior to draw a liquid or gaseous medium from the isolated interior through the functional opening (7); the catheter body is provided with a net or enclosure (16) permeable to liquid or gaseous media, the net or enclosure (16) at least partially surrounding the catheter body portion defined by the balloon (4) and covering the functional opening (7); the functional opening (7) is disposed between two ring-shaped surrounding protrusions (6) provided on the catheter body portion defined by the balloon (4); The catheter (100) is characterized in that the net or enclosure (16) is attached to or surrounds the balloon (4) so ​​that the net or enclosure (16) is in tension when the balloon (4) is inflated.

9. 9. The catheter (100) of claim 8, further comprising a second channel (1) extending within the catheter body, the second channel (1) being provided at both ends with an inlet (5.2) and an outlet (5.1) provided within the catheter body outside the catheter body portion defined by the balloon (4).

10. 1. A system for isolating the interior of a hollow organ of a mammal, comprising: A catheter (100) according to any one of claims 1 to 9; a functional device connected to said functional channel (3) and adapted to generate a negative pressure in said isolated interior to draw a liquid or gaseous medium from said isolated interior.

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