catheter

Abstract

A catheter for isolating an area in a hollow organ of a mammal, the catheter having an elongated body designed to be inserted into the lumen of the hollow organ of the mammal, and the catheter being equipped with two balloons configured to be inflated to isolate the interior of the hollow organ between the balloons; wherein a functional channel extending in the body has a functional opening arranged in the body between the balloons; and wherein the functional channel is designed to allow negative pressure to be generated in the isolated interior to obtain biological fluid or biological gaseous medium from the isolated interior or to allow liquid or gaseous medium to be supplied to the isolated interior; and wherein another channel extending in the body is provided with an inlet and an outlet at opposite ends, the inlet and the outlet being both arranged in the body, outside the body portion defined by the balloons.

Description

Technical Field

[0001] The present invention relates to medicine, and more particularly to medical devices for diagnosing, monitoring and / or treating inflammatory, autoimmune, infectious, benign and / or malignant diseases that occur in mammalian hollow organs or in other mammalian organs associated with mammalian hollow organs, in particular diseases of the pancreas, bile duct, liver, gastrointestinal tract, as well as defects and injuries, fistulas, stenoses, aneurysms and diverticular dilatations of mammalian hollow organs, and other diseases of hollow organs. Background Art

[0002] Various devices and instruments are known in the art for diagnosing and / or treating inflammatory, autoimmune, infectious, benign and / or malignant diseases occurring in hollow organs of mammals, in particular pancreatic diseases, bile duct diseases, liver diseases, as well as gastrointestinal wall defects, wall injuries of hollow organs, aneurysms and diverticular dilatations, hollow organ stenosis, hollow organ bleeding and some other diseases of hollow organs, as well as diseases of organs connected to these hollow organs.

[0003] According to the guidelines for diagnosing and treating pancreatic cancer, the main techniques for confirming the histological type of a tumor are fine-needle percutaneous core biopsy, fine-needle functional biopsy, cytological analysis of epithelial scrapings (also referred to as brush biopsy in the art), diagnostic laparoscopic biopsy, and cytological analysis of washings obtained from the abdominal cavity during laparoscopic surgery or laparotomy (pancreatic cancer guidelines, National Comprehensive Cancer Network, 2019 version 2.2019). These officially recommended biopsy techniques are based on different principles, so these techniques cannot be considered as the closest prior art to the present invention.

[0004] In particular, an ultrasound method for studying the pancreas is known in the art (Minko AB, Complex beam diagnostics of pancreas diseases / AB Minko, BC Pruchansky, LI Korytova, SPb: Hippokrat, 2001, p. 134, Martínez-Noguera A., Montserrat E., Torrubia S. et al., 2001) Ultrasound of the pancreas: update and controversies, Eur Radio 11: 1594-1606). Ultrasonic methods are based on the evaluation of changes in the reflection and absorption of waves from organ tissues, and allow the determination of glandular contours, liver contours and alternations of hyperechoic or hypoechoic areas. In addition, ultrasonic methods allow the determination of the main pancreatic duct structure and its diameter, bile duct structure and its diameter, and other structures and their diameters. The main disadvantage of ultrasonic methods is that the results of the examination depend on the qualifications of the experts and the resolution of the device. In this case, the sensitivity of ultrasonography is 70-80%. If the size of the structure is less than 1.5 cm, the effectiveness of the ultrasonic method is greatly reduced. In particular, ultrasonic methods cannot detect tumors in the duct, cannot fully evaluate the pancreatic duct, cannot evaluate the biochemical composition of pancreatic juice and bile, and cannot perform cytological examinations on pancreatic juice and bile.

[0005] In addition, an endoscopic ultrasound examination method based on the same principle as the above-mentioned ultrasound method is known in the art (see Ogawa M., Kawaguchi Y., 2011, Iglesias-Garcia J., 2012). The advantage of endoscopic ultrasound examination over ultrasound methods is that biopsy can be performed in close proximity to the site of interest. A convex probe (if available) allows the examination of suspicious structures with fine needle functional biopsy, followed by cytological examination. The disadvantages of endoscopic ultrasound examination are as follows: it requires a highly skilled specialist, requires the assistance of anesthesia, is costly, and in some cases cannot be performed due to certain anatomical features. In addition, endoscopic ultrasound examination is not suitable for performing cytological diagnosis of the liver and bile duct, and can only obtain a small amount of cytological material by aspiration, so it is difficult to interpret the obtained cytological material, resulting in a high proportion of false positive results and false negative results. In addition, endoscopic ultrasound examination does not allow qualitative analysis of the components of bile or pancreatic juice.

[0006] Furthermore, fine needle biopsy is known in the art, wherein fine needle core biopsy is always used in combination with the above-mentioned ultrasound method and the above-mentioned endoscopic ultrasound examination and allows 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, No. 8, pp. 977-87). Fine needle biopsy is the main method for histological verification of pancreatic diseases. The disadvantages of fine needle biopsy are possible complications: bleeding, fistula formation, abscess, spread of cancer cells along the puncture channel, and uninformative, false-positive or false-negative results of histocytological examination. Additionally, fine needle biopsy is not suitable for diagnosing diseases of the bile duct and gallbladder, nor for laboratory evaluation of bile or pancreatic juice.

[0007] In addition, a method of spiral computer-assisted tomography (MSCT) with intravenous contrast is known in the art (Callery MR et al., 2009; Klaub M. et al., 2009). Spiral computer-assisted tomography is based on computer-assisted processing of thin "slice" tomographic images, assessment of the degree of contrast absorption by glandular or tumor tissue, and measurement of ductal diameter. Spiral computer-assisted tomography allows visualization of structures and, based on changes in organ density parameters, determines whether changes in acute or chronic inflammation of the corresponding organ are observed. The disadvantage of spiral computer-assisted tomography is that its sensitivity decreases significantly when the size of the structure is less than 1.5 cm, and the sensitivity and specificity are low in diagnosing intraductal tumors. In addition, spiral computer-assisted tomography does not allow histological confirmation of the disease, nor analysis of pancreatic secretions.

[0008] In addition, the endoscopic retrograde cholangiopancreatography (ERCP) method is known in the art (Kawaguchi Y., Ogawa M., Omata F., Randomized controlled trial of pancreaticstenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography, World Journal of Gastroenterology, 2012, Vol. 18, No. 14, pp. 1635-1641). In endoscopic retrograde cholangiopancreatography, focal structures and stones are displayed in the form of filling defects. The disadvantages of endoscopic retrograde cholangiopancreatography are the need for anesthesia assistance, some limitations that prevent certain manipulations, and surgery-related injuries, which may lead to destructive pancreatitis or acute cholangitis.

[0009] In addition, a method known in the art of using Chirhostim TMEndoscopic aspiration of pancreatic fluid from the duodenum using 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. dysplasia. Clin Gastroenterol Hepatol., 2013, Vol. 11, No. 6, pp. 719-730). Endoscopic aspiration is used to sample material followed by cytological examination and / or molecular genetic analysis. The disadvantages of endoscopic aspiration are as follows: lack of public acceptance and limitation of the amount of pancreatic secretion sampled by the operation time due to the short duration of drug action. It is worth noting that the composition of pancreatic juice may change when secretin or its analogs are administered, so that in this case the sampled pancreatic secretion does not have its natural composition, so it is not impossible to assess the true composition and secretory clearance of pancreatic juice when this function is stimulated by drugs. Endoscopic aspiration is also not suitable for collecting and analyzing bile.

[0010] In addition, magnetic resonance imaging (MRI) methods are known in the art for determining tumors and inflammatory changes in the pancreas and / or bile duct (Akisik MF, Sandrasegaran K., Aisen AA, Dynamic secretin enhanced MR cholangiopancreatography, Radiology, 2006, 26, pp. 665-677). Magnetic resonance imaging is a non-invasive method and provides higher sensitivity and specificity when used in combination with radiographic opacification or stimulation of the pancreatic excretory function. The disadvantage of magnetic resonance imaging is that it cannot evaluate the composition and clearance of bile or pancreatic juice, nor is it possible to perform cytological examination of bile or pancreatic juice.

[0011] In addition, a method of performing nasopancreatic or nasobiliary drainage and then isolating and sampling the matrix is ​​known in the art (Handa K., Minami T., Shimizu A., et al., Roles of ERCP in the Early Diagnosis of Pancreatic Cancer, Diagnostics, 2019, Vol. 9, No. 1, p. 30; Budzinsky SA, Shapovalens SG, Fedorov ED, Shabrin A.V., Endoscopic transpapillary pancreatic stenting in the treatment of pancreatic fistulas (with a commentary by AG Krieger) AG Krieger)], Journal named after NI Pirogov [NIPirogov], 2017, No. 2, pp. 32-44). Nasopancreatic or nasobiliary drainage is used both for the treatment of inflammatory pancreatic diseases and for their cytological verification, wherein nasopancreatic or nasobiliary drainage is suitable for the analysis of the composition of biological fluids. In addition, nasopancreatic or nasobiliary drainage is a single method that allows independent sampling of pancreatic juice and bile. The disadvantage of nasopancreatic or nasobiliary drainage is the complexity of its implementation. The use of nasopancreatic or nasobiliary drainage was first described in 1980, but nasopancreatic or nasobiliary drainage is not a routine method and is used only in highly specialized institutions, in particular for solving a limited range of tasks, mainly for the treatment of acute pancreatitis. In some cases, in particular due to the presence of certain anatomical features, nasopancreatic or nasobiliary drainage may not be possible and may lead to various complications such as pancreatitis, cholangitis and bleeding.

[0012] Furthermore, dual-channel Dreiling tubes for performing duodenal cannulation are known in the art (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, Vol. 67, No. 3, pp. 458-466; Pollack BJ, Grendell JH, Where have all the dreiling tubes? gone?], American Journal of Gastroenterology, February 2006, Vol. 101 No. 2: 356-nine). The Dreiling tube allows non-invasive sampling of pancreatic juice and bile, which is then subjected to biochemical tests and / or cytological examinations and determination of daily clearance. The disadvantage of the Dreiling tube is that the contents of the duodenum cannot be selectively sampled, resulting in retrograde sampling of the intestinal contents. The passive nature of the excreta sampling leads to a partial loss of it in the distal part due to the peristalsis of the duodenum. However, it is worth noting that the passive positioning of the tube is achieved by the olive weight of the distal part of the tube and the peristalsis of the gastrointestinal tract, which can lead to excessive time required for tube positioning and the need to perform radiographic imaging to correct its position, wherein it is difficult to provide proper positioning of the channel of the tube for sampling pancreatic juice and bile. The use of stimulating drugs (such as secretin) cannot be considered an appropriate solution because they only increase the bicarbonate buffer excretion provided by the pancreatic cells, i.e., only the activity of the epithelial cells covering the duct is stimulated, and most of the exocrine gland ducts in the exocrine gland ducts remain inactive. Therefore, the Dreiling probe has no function in stimulating adenocarcinomas, mucinous tumors, and neuroendocrine tumors. In addition, the Dreiling tube is an alternative to endoscopic retrograde pancreatocholangiopancreatography and can only be used to diagnose chronic pancreatitis, where intraductal mucinous and cystic formations and carcinomas cannot be visualized in situ by using the Dreiling tube. In addition, when the Dreiling tube is used, it is difficult to evaluate bile secretion because part of the bile or pancreatic juice passes through the duodenum next to the Dreiling tube.

[0013] In addition, nasopancreatic stent placement, which is inserted into the main pancreatic duct using endoscopic techniques, is known in the art (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, Vol. 13, No. 4: 453-8; Minami T., Hanada K., Hirano N. et al., Clinical Usefulness of Serial Pancreatic-Juice Aspiration Cytology and Endoscopic Ultrasound-Guided Fine Needle Aspiration in Small Pancreatic Cancers). Cytological Examination and Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Small Pancreatic Cancer, 152, No. 5, Suppl. 1, p. S897; Bi Y., Ji B., Raimondo M., How to suction pancreatic juice from the duodenum: Endoscope, catheter, or cap-assisted, 86, No. 6, 2017, Journal of Gastrointestinal Endoscopy, pp. 1157-1159). During endoscopic sphincterotomy, nasal pancreatic stents allow the insertion of a probe and therefore the acquisition of pancreatic secretions. The disadvantage of nasal pancreatic stents is that they are invasive and can lead to the development of pancreatitis, cholangitis, or obstructive jaundice. In 3-10% of cases, ERCP may provoke acute pancreatitis, so in this case all patients must undergo special preventive treatment. In addition, during the papillary sphincterotomy, large blood vessels may be damaged, which can lead to bleeding. It is important to note that nasal pancreatic stents should only be used in highly specialized centers by experts with experience in this procedure.

[0014] Additionally, double-lumen duodenal probes that are inserted through the nasal passage under endoscopic control are known in the art, allowing the duodenal probe to be advanced through the pyloric duodenal region (Bi Y., Ji B., Raimondo M., How to suction pancreatic juice from the duodenum: Endoscope, catheter, or cap-assisted?, Vol. 86, No. 6, 2017, J. Gastrointest. Endosc, pp. 1157-1159; Go VL, Hofmann AF, Summerskill WH, Simultaneous measurements of total pancreatic, biliary, and gastric outputs in man using a perfusion technique perfusion technique], Gastroenterology, 1970, Vol. 58, pp. 321-328). The disadvantages of the duodenal probe are the inability to selectively sample pancreatic juice and bile and the lack of a barrier to mixing of excreta with gastrointestinal contents, which would lead to activation of pancreatic enzymes and digestion of biological material in the probe. In addition, it is worth noting that the design of the duodenal probe does not allow one to influence the outflow of pancreatic juice from the pancreas, so in order to obtain juice and perform its examination, the pancreas must be stimulated by drugs such as secretin.

[0015] Furthermore, a pancreatic juice suction device is known in the art, which is configured to suction pancreatic juice by using an endoscope (formed as a cap mounted on a fiber endoscope), wherein the cap allows the collection of pancreatic secretions after stimulating the exocrine function of the organ (Suenaga M, Sadakari Y, Almario JA, et al., Using a cap at the distal end of an endoscope to collect pancreatic juice from the ampulla (with video, Gastrointest Endosc, 2017, Vol. 86, pp. 1152-1156). The disadvantages of the suction device are as follows: the procedure is complicated because it can only be performed in highly specialized centers, and the amount of pancreatic secretions collected is small (where the available amount of pancreatic secretions is a key aspect of molecular testing). In this case, the procedure based on the use of the suction device is performed by using an anesthetic, wherein the procedure cannot be performed for a long time.

[0016] A method for diagnosing viral hepatitis in the blood by using serological and molecular genetic methods is known in the art. However, in 20% of cases, the disease remains unconfirmed because the disease is restricted by the life cycle of the virus and the tropism of the disease for hepatocytes and bile duct epithelial cells, resulting in 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, No. 5, pp. 479-482). This diagnostic method does not allow for obtaining bile for further laboratory analysis.

[0017] A method for diagnosing liver diseases (viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, liver tumors) by performing a percutaneous biopsy followed by histological and molecular genetic analysis is known in the art (Bunt EM, Liver Biopsy Diagnosis of Hepatitis: Clues to Clinically-Meaningful Reporting, Mo Med, 2010, Vol. 107, No. 2, pp. 113-118). In some cases, this method leads to complications (bleeding, bile peritonitis). At the same time, this method does not allow one to reveal pathological changes in about 30% of cases. In addition, this method is exclusively used for primary diagnosis and is virtually never used repeatedly, for example to monitor the dynamics or development and progression of the disease.

[0018] Furthermore, a method of treating acute pancreatitis by stenting the main pancreatic duct to restore the outflow of pancreatic enzymes is known in the art. This approach is used to treat and prevent pancreatitis before performing 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 an acute pancreatitis, Surgery, NI Pirogov, 2019, 9, 13–17; Dumonceau JM., Andriulli A., Elmunzer BJ., et al., Prophylaxis of post-ERCP pancreatitis: European Society for Gastrointestinal Endoscopy (ESGE) guidelines - June 2014 update). ofpost-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline-updated June 2014], Endoscopy, September 2014, Vol. 46, No. 9, pp. 799-815). The disadvantage of this method is that stenting can only be performed in highly specialized centers, where in some cases, due to the anatomical characteristics of the patient's ductal system, this procedure cannot be performed at all. In addition, this procedure does not solve the problem of pancreatitis due to the obstruction of pancreatic fluid outflow associated with duodenal paralysis.

[0019] Furthermore, on average 1-3% of patients develop intestinal fistulas 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 associated with this pathology ranges between 16.5% and 57.5%, and the postoperative mortality associated with this pathology ranges between 10% and 21.4%, with the highest mortality observed for disembodied intestinal fistulas, ranging between 36% and 71.7%. The mortality for embodied intestinal fistulas barely reaches 4%.

[0020] A method for treating gastrointestinal fistulas by using a system that generates negative pressure is known in the art, wherein the method is based on the continuous drainage of all pathological secretions from the abdominal cavity, thereby healing the defect (Bobkiewicz A, Walczak D, Smoliński S., et al., Management of enteroatmospheric fistula with negative pressure wound therapy in open abdomen treatment: a multicenter observational study, Int Wound J, February 2017, Vol. 14, No. 1, pp. 255-264; D'Hondt M., Devriendt D., Van Rooy F., et al., Treatment of small-bowel fistulae in the open abdomen with local negative pressure therapy. 202, No. 2, e20-4). In addition, statistics collected by the same authors in cases where this method was used showed that such defects did not close (heal) in 30-47% of cases due to the continuous production and reception of contents from the lumen of the hollow organ.

[0021] Furthermore, there are a large number of different occluder-like devices that are intended to disconnect the lumen of a hollow organ with a wall defect. However, the large variety of such devices indicates the difficulty in their implementation and in achieving the desired effect. Moreover, all these well-known devices are intended only to disconnect the lumen of a hollow organ with a wall defect, and are not intended to affect the area adjacent to the wall defect (Vitsyn BA, Blagitko EM, Formed and unformed external intestinal fistulas, Novosibirsk: Nauka., 1983, p. 142; Makarenko TP, Bogdanov AV, Gastrointestinal fistulas, M.: Medicine, 1986, p. 144, USSRAS 764685, M. class A61M 27 / 00, Obturator for temporary closure of a gastrointestinal fistula / VM Udod Udod] and EG Karsten, published as application 2723729 / 28-13 on December 22, 1978, publication number 09 / 23 / 80. BI35).

[0022] Methods known in the art for treating gastrointestinal bleeding are based on the use of endoscopic methods, clipping, ligation, injection of sclerosants or vasoactive drugs into the mucosal layer, and coagulation using thermal and electrical methods (Anjiki H, Kamisawa T, Sanaka M, Ishii T, Kuyama Y, Endoscopic hemostasis techniques for uppergastrointestinal hemorrhage: A review, World J GastrointestEndosc, 2010, Vol. 2, No. 2, pp. 54-60). Moreover, these known methods remain ineffective in cases of bleeding from putrefactive tumors, necrotizing esophagitis or non-specific erosive colitis, i.e., in cases of diffuse mucosal bleeding without an obvious source, and these methods also do not allow objective control of the stability of hemostasis.

[0023] A method for diagnosing dilatation of a vascular aneurysm is known in the art by administering an intraluminal intravascular catheter with or without a stent, including guiding the catheter under fluoroscopic control and occluding the aneurysm with the stent (Roszelle BN, Nair P, Gonzalez LF, HaithemBabiker M, Ryan J, Frakes D, Comparison among different highporosity stent configurations: hemodynamic effects of treatment in a largecerebral aneurysm, J Biomech Eng, February 2014, Vol. 136, No. 2: 021013). However, if this known method is implemented, circumferential blood flow may be compromised during positioning the catheter in a correct manner and identifying the defect, and bleeding from the aneurysm cavity may continue. Therefore, existing analogs are different from the claimed technology.

[0024] It is known in the art to detect 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, April 2019, volume 26, issue 2, pages 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's appropriateness criteria. Tomography-a national survey and comparison with the american college of radiology appropriateness criteria], Journal of Emergency Medicine [J Emerg Med.], February 2013, Vol. 44, No. 2, pp. 423-33). However, the manipulation itself only allows the determination of the lesion, which is not always possible, since the success of the determination of the lesion depends largely on the location of the lesion and the characteristics of the substance administered. In other words, this known method is not always able to accurately locate the lesion of the hollow organ and cannot treat the lesion.

[0025] A similar catheter for isolating the interior of a hollow organ of a mammal is disclosed in U.S. Pat. No. 9,526,874, published on June 30, 2015. The catheter disclosed in US 9,526,874 includes an elongated body designed to be inserted into the lumen of a hollow organ of a mammal, and the catheter includes two balloons configured to be inflated to isolate the interior of the hollow organ of the mammal between the balloons, and the catheter includes a functional channel extending in the catheter body, the functional channel including a functional opening disposed in the catheter body between the balloons, wherein the functional channel is designed to allow: generating a negative pressure in the isolated interior to obtain a biological fluid specific to the hollow organ from the isolated interior, or allowing a liquid or gaseous medium to be supplied to the isolated interior.

[0026] A disadvantage of the catheter disclosed in US 9,526,874 is that it cannot be inserted into the lumen of a mammalian hollow organ for a long period of time due to the lack of physiological connection between the hollow organ portion adjacent to the hollow organ region isolated by the inflated balloon and outside the isolated region of the hollow organ.

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

[0028] The main disadvantage of the catheters disclosed in US 478167, US 5460610, WO 2018106788 or US 5222941 is that the functional opening of the catheter body may be quickly blocked or occluded by the tissue of the hollow organ and / or materials associated with the catheter body or catheter structural components. Therefore, the catheter cannot be used in the hollow organ for a long time and the hollow organ of the mammal may be damaged.

[0029] The closest prior art to the present invention is the catheter disclosed in US 5951514 (IPC: A61M29 / 00; Publication Date: September 14, 1999). The catheter disclosed in US 5951514 has the same disadvantages as the above-mentioned catheters disclosed in US 478167, US 5460610, WO2018106788 and US 5222941.

[0030] Therefore, catheters and systems for isolating the interior of a hollow mammalian organ will be further developed, particularly to prevent the functional opening of the catheter body from being blocked or occluded by hollow organ tissue, thereby preventing damage to the hollow mammalian organ when the catheter is used therein.

[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 eliminate the above-mentioned shortcomings of the catheters in the prior art, namely, eliminate the problem of functional openings being blocked or occluded by hollow organ tissue, thereby possibly causing damage to the hollow organ of the mammal during the use of the catheter. Summary of the invention

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

[0033] To achieve the purpose of the present invention as embodied and broadly described herein, in a first aspect of the present invention, a catheter for isolating the interior of a hollow organ of a mammal is provided, the catheter comprising: an elongated catheter body designed to be inserted into a lumen of a hollow organ of a mammal; two balloons, the two balloons being individually and separately disposed along the catheter body and configured to be inflated to isolate the interior of the hollow organ between the balloons; and a functional channel extending in the catheter body and comprising a functional opening disposed in the catheter body between the balloons, and wherein the functional channel is designed to allow: A negative pressure is generated in the catheter body to obtain a fluid or a gaseous medium from the isolated interior via the functional opening, and / or a liquid or a gaseous medium is supplied to the isolated interior via the functional opening; and a second channel extending in the catheter body is provided with an inlet and an outlet at opposite ends, and the inlet and the outlet are both provided in the catheter body, on the outside of the isolated interior defined by the balloon, wherein the catheter body is also provided with a net or a shell, which is permeable to the fluid and / or the gaseous medium, wherein the net or the shell at least partially surrounds the catheter portion defined by the balloon so as to cover the functional opening, and wherein the net or the shell is attached to the balloon or surrounds the balloon so that the net or the shell becomes taut when the balloon is inflated.

[0034] The main technical effect provided by the catheter for isolating the interior of a hollow organ of a mammal according to the first aspect of the present invention is that the safety of the catheter is improved by preventing the tissue of the hollow organ of the mammal from being sucked into the functional opening of the catheter body, thereby causing damage to the tissue of the hollow organ. In particular, in the present invention according to the first aspect, due to the fact that the mesh or shell in a tensioned state covers the functional opening, the hollow organ tissue and / or the mesh shell is prevented from being sucked into the functional opening.

[0035] Another technical effect provided by the catheter for isolating the interior in a hollow organ of a mammal according to the first aspect of the invention is the prevention or exclusion of the formation of congestion and / or inflammatory processes that may occur in the hollow organ due to the accumulation of mucus and other biological contents specific to the hollow organ outside the isolated interior defined by the balloon. In particular, in the first aspect of the invention, the formation of congestion and / or inflammatory processes in the hollow organ is prevented or excluded due to the fact that mucus and other biological contents specific to the hollow organ, when accumulated in the hollow organ, can enter an inlet arranged in the catheter body outside the isolated interior defined by the balloon, and can leave through an outlet arranged in the catheter body outside the isolated interior defined by the balloon.

[0036] Another technical effect provided by the catheter for isolating the interior of a hollow organ of a mammal according to the first aspect of the present invention is that the reliability of the catheter is increased by preventing partial or complete blockage or occlusion of the functional opening, which may be caused by aspiration of hollow organ tissue into the functional opening and may make it necessary to retrieve the installed catheter from the hollow organ of the mammal and then replace the retrieved catheter with a new catheter or remove the hollow organ tissue that has entered the functional opening from the functional opening of the retrieved catheter.

[0037] In one embodiment of the invention according to the first aspect, the catheter may further include an expansion channel extending in the body for delivering a fluid or gaseous medium to the balloon of the catheter to expand the balloon. Delivering fluid to the catheter balloon via an additional channel disposed in the catheter body to expand the balloon provides further technical effects, including simplifying the balloon size required to maintain the interior of the lumen of a hollow organ of a mammal inserted by the catheter, and simplifying the regulation of the size or degree of expansion of the catheter balloon.

[0038] In another embodiment of the present invention according to the first aspect, the second passage can also be configured to supply liquid to the catheter body, and is further provided with an additional outlet at the catheter distal end, which is used for inserting the catheter into the lumen of a mammalian hollow organ. The second passage provides a further technical effect that the mammalian hollow organ is sanitized (particularly the air in the esophagus, stomach, duodenum, small intestine, large intestine and respiratory tract, the urine in the urethra or the blood in the blood vessel are sanitized), and medical products can be provided simultaneously. The enteral nutrition mixture can provide basic nutrients, energy, vitamins, macronutrients, and / or micronutrients etc. for the organism completely, and can also be provided to the inside of the hollow organ, while sampling biological fluids or biological gaseous media from the isolation area of ​​the hollow organ or supplying liquid or gaseous media to the isolation area of ​​the hollow organ. These features allow the catheter to be inserted into the lumen of the mammalian hollow organ for a long time.

[0039] In another embodiment of the present invention according to the first aspect, each of the functional channel, the second channel and the expansion channel can be sealed and isolated from each other. The sealed isolation channel in the conduit provides further technical effects, in particular preventing different contents from entering the functional channel from other conduit channels, and thus preventing different contents from mixing with biological fluids or biological gaseous media, which will negatively affect the reliability or representativeness of laboratory instrument analysis results obtained for biological fluids or biological gaseous media, or preventing different contents from mixing with liquid or gaseous media supplied to isolated areas of a hollow organ of a mammal.

[0040] In some embodiments of the present invention according to the first aspect, two annular projections surrounding the functional opening can also be arranged on the catheter body, between the balloons, so that the functional opening is positioned between the annular projections. The annular projections surrounding the functional opening arranged on the catheter body provide a further technical effect, namely preventing the hollow organ tissue, particularly the mucous membrane tissue of the hollow organ from being aspirated by the functional opening, because the annular projections do not allow the functional opening to directly contact the tissue or approach the tissue at a distance suitable for aspirating the tissue when negative pressure is generated inside the hollow organ isolated by the catheter balloon.

[0041] To achieve the purpose of the present invention as embodied and broadly described herein, in a second aspect of the present invention, a catheter for isolating the interior of a hollow organ of a mammal is provided, the catheter comprising: an elongated body designed to be inserted into a lumen of a hollow organ of a mammal; two balloons, the two balloons being individually and separately disposed along the catheter body and configured to be inflated to isolate the interior of the hollow organ of the mammal between the balloons; and a functional channel extending in the catheter body and comprising a functional opening disposed in the catheter body between the balloons, wherein the functional channel is designed to allow: Generate negative pressure to obtain fluid or gaseous medium from the isolated interior via the functional opening; and a second channel extending in the catheter body is provided with an inlet and an outlet at opposite ends, and the inlet and the outlet are both arranged in the catheter body, outside the isolated interior defined by the balloon, wherein two annular protrusions surrounding the functional opening are also arranged on the catheter body, between the balloons, so that the functional opening is located between and adjacent to the annular protrusions, wherein the annular protrusions are designed so that when negative pressure is generated, the annular protrusions allow a distance to be provided between the mucosal tissue of the hollow organ of the mammal and the functional opening, and the mucosal tissue is located between the inflated balloons.

[0042] The catheter according to the second aspect of the present invention provides the above-mentioned main technical effects for the catheter according to the first aspect of the present invention, in particular, the safety of the catheter is improved due to the prevention of damage to the hollow organ tissue caused by suction of the tissue of the hollow organ of a mammal into the functional opening of the catheter body. In particular, in the present invention according to the second aspect of the present invention, since the annular protrusion surrounds the functional opening arranged in the catheter body, the hollow organ tissue is further prevented from being suctioned into the functional opening. In other words, in the present invention according to the second aspect of the present invention, the annular protrusion does not allow the hollow organ tissue to directly contact the functional opening or approach the functional opening for a distance suitable for suctioning the hollow organ tissue into the functional opening when negative pressure is generated in the isolated interior defined by the airbag.

[0043] The catheter according to the second aspect of the invention provides the additional technical effects of the catheter according to the first aspect of the invention described above, in particular preventing or excluding the formation of congestion and / or inflammatory processes, which may occur in a hollow organ due to the accumulation of mucus and other biological contents specific to the hollow organ outside the insulating interior defined by the balloon. In particular, similar to the first aspect of the invention, in the second aspect of the invention, the formation of congestion and / or inflammatory processes in a hollow organ is also prevented or excluded due to the fact that mucus and other biological contents specific to the hollow organ, when accumulated in the hollow organ, can enter an inlet arranged in the catheter body outside the insulating interior defined by the balloon, and can leave through an outlet arranged in the catheter body outside the insulating interior defined by the balloon.

[0044] The catheter according to the second aspect of the present invention provides further technical effects of the catheter according to the first aspect of the present invention described above, and in particular increases the reliability of the catheter by preventing partial or complete blockage or occlusion of the functional opening, which may be caused by aspiration of hollow organ tissue into the functional opening (due to the fact that aspiration of hollow organ tissue into the functional opening is further prevented: the annular protrusion surrounds the functional opening provided in the catheter body), and may result in the need to retrieve the installed catheter from the hollow organ of a mammal, and then replace the retrieved catheter with a new catheter or remove the hollow organ tissue that has entered the functional opening from the functional opening of the retrieved catheter.

[0045] In addition, the catheter according to the second aspect of the present invention provides for expansion or increase of the volume of an isolated interior in a hollow organ of a mammal (which is used to generate negative pressure therein); this allows the possibility of generating controlled negative pressure in the isolated interior of the hollow organ when necessary, the negative pressure having the level required to provide suction and being specific to different hollow organs of mammals (which have different physiological characteristics), thereby preventing excessive negative pressure from being generated in the isolated interior, which would cause the hollow organ tissue to be sucked into the functional opening and thereby cause damage to the tissue.

[0046] The above-mentioned further technical effect, namely increased reliability of the catheter, is further provided by the catheter according to the second aspect of the invention due to the fact that annular protrusions (these protrusions surround the functional opening positioned therebetween) are arranged between the balloons. In particular, increased reliability of the catheter is provided due to the fact that the increase in the volume of the isolated interior (where negative pressure can be generated) allows the possibility of generating a controlled negative pressure in the isolated interior of the hollow organ where it is necessary to expand, the negative pressure having the level required to provide suction and being specific to different hollow organs of mammals (these hollow organs have different physiological characteristics), and allows preventing partial or complete obstruction or occlusion of the functional opening, which may be caused by the suction of hollow organ tissue into the functional opening, and may result in the need to retrieve the installed catheter from the hollow organ of the mammal, then replace the retrieved catheter with a new catheter or remove the hollow organ tissue that has entered the functional opening from the functional opening of the retrieved catheter.

[0047] In addition, the catheter according to the second aspect of the present invention provides a new technical effect, namely, the practicality of the catheter is improved. The new technical effect is further provided by the catheter according to the second aspect of the present invention due to the fact that annular protrusions (these protrusions surround the functional openings positioned between them) are arranged between the balloons. In particular, the practicality of the catheter is improved due to the following fact: it is necessary to expand the possibility of generating a controlled negative pressure in the isolated interior of the hollow organ, the negative pressure has the level required to provide suction; and / or a liquid or gaseous medium with a required dose or volume (the dose or volume is specific for different hollow organs of mammals (these hollow organs have different physiological characteristics) and / or different deaths of hollow organs of mammals) is supplied to the isolated interior, wherein this possibility of expansion is affected by the increase in the volume of the isolated interior in the hollow organ of the mammal, the isolated interior is used to generate a controlled negative pressure therein and to transfer the liquid or gaseous medium to the isolated interior.

[0048] In addition, the catheter according to the second aspect of the invention provides a further new technical effect, namely suitable centering of a functional opening associated with a target area of ​​a hollow organ of a mammal, the target area being used to aspirate a liquid or gaseous medium therefrom or to deliver a liquid or gaseous medium thereto. In particular, a further new technical effect is further provided by the catheter according to the second aspect of the invention due to the fact that annular protrusions (these protrusions surround the functional opening positioned between these protrusions) are arranged between the balloons.

[0049] According to an embodiment of the invention according to the second aspect, the functional opening may be covered by a mesh or a casing, which is permeable to fluid and / or gaseous media.

[0050] The use of a net or shell permeable to fluid and / or gaseous media for covering the functional opening in the catheter according to the second aspect of the invention contributes to the above technical effect, namely improving the safety of the catheter and increasing the reliability of the catheter, in particular by preventing tissue of a hollow organ from being sucked into the functional opening of the catheter.

[0051] According to another embodiment of the second aspect of the invention, the catheter body may also be provided with a mesh or shell which is permeable to fluid and / or gaseous media, wherein the mesh or shell may at least partially surround the catheter portion defined by the balloon so as to cover the functional opening.

[0052] The use of a shell permeable to fluid and / or gaseous media for covering the functional opening in the catheter according to the second aspect of the invention also contributes to the above technical effect, namely improving the safety of the catheter and increasing the reliability of the catheter, in particular by preventing tissue of a hollow organ from being sucked into the functional opening of the catheter.

[0053] According to a further embodiment of the invention according to the second aspect, a net or a shell may be attached to the balloons or may surround these balloons such that the net or the shell may become taut when the balloons are inflated.

[0054] The use of a shell permeable to fluid and / or gaseous media in the catheter according to the second aspect of the invention, which shell becomes taut between the balloons when the balloons are inflated, also contributes to the above technical effect, namely improving the safety of the catheter and increasing the reliability of the catheter, in particular by preventing aspiration of hollow organ tissue into the functional opening of the catheter.

[0055] According to other embodiments of the present invention according to the second aspect, the mesh or shell may surround the balloon such that the mesh or shell may become taut when the balloon is inflated.

[0056] According to some embodiments of the second aspect of the present invention, the net or the housing may be fixed on the annular protrusion.

[0057] In order to achieve the purpose of the present invention as embodied and broadly described herein, in a third aspect of the present invention, a system for isolating the interior of a hollow organ of a mammal is provided, the system comprising: a catheter for isolating the interior of a hollow chamber of a mammal according to any of the above-mentioned embodiments of the first aspect or the second aspect of the present invention; and a functional device connected to a functional channel to allow negative pressure to be generated in the isolated interior to obtain a fluid or gaseous medium from the isolated interior. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] While the specification concludes with claims that particularly point out and distinctly claim the invention, it is believed that the invention will be better understood from the following description taken in conjunction with the accompanying drawings which illustrate, in a non-limiting manner, the best mode presently contemplated for carrying out the invention and in which like reference numerals refer to like parts throughout the drawings, wherein:

[0059] Figure 1 A catheter for isolating a region in a hollow organ of a mammal according to the invention is schematically illustrated;

[0060] Figure 2 Shows the settings Figure 1 a functional opening in a portion of a conduit;

[0061] Figure 3 A catheter with a mesh shell is shown with the balloon deflated or inflated;

[0062] Figure 4 Shown is a catheter with a mesh shell during balloon inflation. DETAILED DESCRIPTION

[0063] In the context of this document, unless expressly stated otherwise, the term "patient" refers firstly to a potentially ill human (a member of the class mammals) seeking medical advice or being under medical observation for diagnosis and / or treatment of a disease, wherein the term "patient" also refers to a potentially ill mammal who is still under medical observation for diagnosis and / or treatment of his or her disease.

[0064] Furthermore, in the context of this document, unless expressly stated otherwise, the term "mammal" refers to humans or animals, in particular apes and non-human primates, dogs, cats, horses, camels, donkeys, cows, sheep, pigs and other well-known mammals.

[0065] Furthermore, in the context of this document, unless expressly stated otherwise, the term "user" refers to any suitably skilled healthcare professional who is authorized to insert a catheter according to the present invention into a hollow organ of a mammal (in particular a hollow organ of a human), remove a catheter according to the present invention from a hollow organ of a mammal and / or manipulate a catheter according to the present invention inserted into a hollow organ of a mammal, wherein the healthcare professional may be, for example, a surgeon, oncologist, endoscopist, thoracic surgeon, vascular surgeon, urologist, veterinarian, etc.

[0066] Today, the most advanced methods for diagnosing and / or treating inflammatory, autoimmune, infectious, benign and / or malignant diseases occurring in hollow organs of mammals or organs associated with these hollow organs, in particular diseases of the pancreas, bile duct, liver, gastrointestinal tract, as well as defects and injuries, fistulas, stenosis, and / or aneurysms and diverticular dilatations of hollow organs of mammals, are based on liquid biopsy of the organism for the determination of disease-specific features in biological fluids or biological fluids that are specific to the hollow organs of the mammal or organs associated with the hollow organs. In particular, liquid biopsy for the diagnosis and / or treatment of pancreatic cancer in the initial stage and precancerous transformation of mammals is based on the detection of circulating pathological cells, circulating tumor DNA, RNA, proteins, peptides, metabolites, and circulating tumor exosomes in biological fluids (such as blood and pancreatic juice) of the mammalian organism.

[0067] A key aspect of liquid biopsy is the amount of sampled material, and therefore the need to have a sufficient amount of sampled material to perform a diagnosis. An even more critical aspect of liquid biopsy is the localization of the disease in the mammalian organism, in particular tumor localization, since the pathological genetic or other diagnostic material isolated from the sample may be typical of cancers of different hollow organs of the mammal or organs associated with these hollow organs.

[0068] In particular, in view of the above reasons, pancreatic juice is the most appropriate diagnostic fluid for detecting circulating tumor cells, DNA, RNA, proteins, peptides, metabolites, and their exosomes in order to diagnose cancer, mucinous and intraepithelial neoplasms of the pancreas. However, sampling of pancreatic juice is the most difficult problem, which is effectively solved by the catheter 100 according to any of the following embodiments of the present invention. The structural and design features and functions of the catheter 100 according to the present invention are described in 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 thereto.

[0069] It is to be noted that the minor and major duodenal papillae (also referred to in the art as Santorini's papillae and Fateri's papillae, respectively) each represent an anatomical structure in the form of a hemispherical, conical or flattened protuberance at the end of a longitudinal fold of the mucosa located in the middle of the descending part of the duodenum, particularly about 12-14 cm below the pylorus, wherein in most cases one opening common to the bile duct and the pancreatic duct is exposed to the duodenal lumen, while in other cases the pancreatic duct is exposed 2-4 cm above the duodenal papillae. The hepatopancreatic ampullae are located in the duodenal papillae, which are used to receive bile and digestive juices from the pancreas and house the sphincter of Oddi that regulates the flow of bile or pancreatic juice into the duodenum and prevents intestinal contents from entering the bile duct and the pancreatic duct. Thus, the large duodenal papilla in the duodenum of mammals is usually located 12-14 cm below the pylorus, while the small duodenal papilla is located 2-4 cm above the large duodenal papilla.

[0070] In particular, in order for pancreatic juice to flow into the duodenal lumen, it is necessary to generate a physiological negative pressure at the level of 40-100 mmH2O around the papilla of Vater or the major duodenal papilla, which is usually achieved by peristalsis of the duodenum (Physiology of digestion, S. Teesalu, 1987, Tartu, Tartu State University, p. 84; The pancreas, 3rd edition, 2018, Blackwell, UK, 1300). Another criterion is the need to isolate and sample pancreatic juice containing inactive digestive enzymes but without gastric and duodenal juice and contents, because the presence of gastric and duodenal juice and contents can lead to enzyme activation and digestion of cells, DNA, RNA, proteins, peptides, metabolites, exosomes required for diagnosis.

[0071] Figure 1-Figure 4 A catheter 100 for isolating a region in a hollow organ according to the present invention is schematically illustrated, wherein the catheter 100 is a catheter inserted into the lumen of a hollow organ by a user, and wherein the lumen or body of the catheter 100 is formed as a flexible hollow tube having dimensions, in particular length and thickness, suitable for user-assisted insertion or advancement thereof within the lumen of the hollow organ toward a placement site. The user manipulating the catheter 100 may be a suitably skilled healthcare professional, such as a surgeon, oncologist, endoscopist, thoracic surgeon, vascular surgeon, urologist, veterinarian, etc. The catheter 100 for isolating a region in a hollow organ may be used for any patient, in particular any person or animal.

[0072] Figure 1 The catheter 100 is provided with 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 placement site in a lumen of a hollow organ of the patient (particularly in the gastrointestinal tract, bile duct, respiratory tract, urinary system, blood vessels of the patient, cavities associated with the uterus and vagina, etc.). In addition, the catheter 100 is equipped with a three-way connector 12 at its proximal end opposite to the distal end of the catheter 100, wherein the proximal end is positioned outside the patient's body when the catheter 100 is inserted into the lumen of the hollow organ of the patient. In particular, when the catheter 100 is used to isolate an area in the duodenum of a patient, the catheter 100 is administered or inserted into the nasal passage of the patient through its distal end, and then the inserted catheter 100 is advanced along the duodenum of the patient to the placement site in the duodenum of the patient.

[0073] like Figure 1 As shown, the three-way connector 12 in the conduit 100 can be a tube or pipe provided with three branches or terminals: a central terminal 9, and two side terminals 8 and 10 sealed and isolated relative to the central terminal 9, wherein the terminals 8, 9, 10 are each provided with a corresponding opening at their free ends, and each terminal is configured to be connected to or engaged to an appropriate functional appliance or functional device.

[0074] The central terminal 9 positioned between the two side terminals 8, 10 in the three-way connector 12 is configured to be connected to or engaged to an appropriate (first) functional appliance or functional device, wherein the first functional device can be any device known in the art for supplying a gaseous medium or fluid (not shown), such as an enteral nutrition mixture. The device for supplying a gaseous medium or fluid such as connected to the central terminal 9 can be, for example, a syringe, which is filled with an enteral nutrition mixture, for example, to provide basic nutrients, energy, vitamins, macronutrients, and / or micronutrients, etc. to the patient's organism; or the device is a medical dropper filled with, for example, an enteral nutrition mixture, or other automated or semi-automated devices and appliances suitable for connecting the central terminal 9 thereto and supplying a gaseous medium or fluid, such as an enteral nutrition mixture, to the central terminal 9. Therefore, when the catheter 100 is inserted into the lumen of the duodenal tube (or other part of the gastrointestinal tract), the device for supplying a gaseous medium or fluid connected to, or attached to, the central terminal 9 can be used to provide, for example, nutritional support or clinical nutrition to the patient. Furthermore, when connected or attached to the central terminal 9, the device for supplying a liquid or gaseous medium can be used, for example, to sterilize the stomach and duodenum of a patient.

[0075] The side terminal 8, which is one of the two side terminals in the three-way connector 12, is designed to be connected or attached to an appropriate (second) functional appliance or functional device, wherein the second functional device can be implemented as a medical suction device, a suction device or an aspirator (not shown), for example, which includes a reservoir or storage container (not shown) for collecting biological gaseous media, biological liquids and / or biological fluids, and an air compressor (not shown) for aspirating or exhausting air or other appropriate gaseous media. Those skilled in the art can adjust the pressure for aspirating or exhausting air or another appropriate gaseous medium based on the information disclosed in the prior art documents (e.g., U.S. Patent No. 6712798) for the corresponding hollow tube.

[0076] In addition, the second functional device attached to the side terminal 8 in the three-way connector 12 can be formed as a special device, or a device for supplying a gaseous medium or fluid (e.g., a medical product), such as a syringe filled with a liquid to be supplied, or a medical dropper filled with a liquid to be supplied, or other automated or semi-automated devices or instruments that are suitable for connecting to the side terminal 8 and supplying the gaseous medium or fluid to the side terminal 8.

[0077] The other side terminal 10 in the three-way connector 12 is configured to be connected or attached to an appropriate (third) functional appliance or functional device, wherein the third functional device can be implemented as a special device, or a device for supplying a liquid or a gaseous medium under pressure (not shown, for example, water or air), in particular a syringe filled with the liquid or gaseous medium to be supplied (for example, water or air), or a medical dropper filled with the liquid to be supplied (for example, water), or other automated or semi-automated devices and appliances that are suitable for connecting to the side terminal 10 and supplying the liquid or gaseous medium to the side terminal 10.

[0078] It should be noted that the first functional device (not shown) can be connected to the central terminal 9 of the catheter 100 for supplying liquid (e.g., enteral nutrition solution), the second functional device (not shown) can be connected to the side terminal 8 of the catheter 100 for sampling biological fluid or biological gaseous medium or supplying liquid or gaseous medium, and / or the third functional device (not shown) can be connected to the side terminal 10 of the catheter 100 for supplying liquid (e.g., water), in combination with Figure 1-Figure 4 The catheter 100 shown in the figure can form a system for isolating a region in a hollow organ of a mammal (not shown), which can be used to sample a biological fluid or a biological gaseous medium (e.g., a biological liquid) that is specific to a specific hollow organ of the mammal, or can constitute a corresponding part of such a system. In particular, the above system can be used to isolate a region in the duodenum of a mammal to sample pancreatic juice and / or bile.

[0079] In addition, if Figure 1-Figure 4 As shown, the body of the catheter 100 is provided with two isolation balloons 4 on the outside thereof, each isolation balloon 4 being formed as an expanded or inflated flexible reservoir, wherein the isolation balloons 4 are spaced apart from each other at a predetermined distance and from the distal end of the catheter 100. A functional orifice or opening 7 is provided between the isolation balloons 4 in the body of the catheter 100. When the catheter 100 is inserted into the lumen of a hollow organ of a patient, one of the isolation balloons 4, i.e., the isolation balloon farthest from the distal end of the catheter 100, is positioned farther than the region of interest in the hollow organ, while the other isolation balloon 4 is isolated until the region of interest in the hollow organ, wherein the functional opening 7 is opposite to or close to the region of interest, for example, opposite to or adjacent to one of the small duodenal papilla and the large duodenal papilla, between the small duodenal papilla and the large duodenal papilla, opposite to or adjacent to an intestinal fistula, opposite to or adjacent to a wall injury, opposite to or adjacent to a tumor, etc.

[0080] Furthermore, the catheter 100 for isolating a region in a hollow organ comprises three separate functional channels arranged in the elongated body of the catheter 100: a main channel 1, a supply channel 2 for supplying a liquid or gaseous medium to the isolation balloon 4, and a functional channel 3 separated from the supply channel 2 and sealed and isolated relative to the main channel 1, the supply channel 2 being sealed and isolated relative to the main channel 1 and having holes arranged in the catheter body 100, and each hole leading to the interior of one of the corresponding isolation balloons 4. The supply channel 2 and the functional channel 3 extend within a portion of the main channel 1 along the length of the main channel.

[0081] The main channel 1 extending substantially along the entire length of the catheter 100 is in communication with the central terminal 9 of the three-way connector 12, wherein the main channel 1 has an inlet hole or an inlet corresponding to the opening in the central terminal 9 provided at the proximal end of the catheter 100, and an outlet hole or an outlet corresponding to the axial hole 11 at the distal 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 main channel 1 is positioned outside the patient's body to communicate with the surrounding atmosphere or environment, and the outlet of the main channel 1 is in communication with the lumen of the organ (e.g., the esophagus, stomach and duodenum, small intestine or large intestine, and respiratory tract, biliary tract, urinary tract, blood vessels, etc.). Therefore, 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 nutrition mixture, can be initially supplied from the first functional device under pressure through a hole made therein to the central terminal 9, then supplied from the central terminal 9 to the main channel 1, and finally supplied from the main channel 1 through the central terminal 9. Figure 1 The axial hole 11 shown supplies the interior of the hollow organ.

[0082] The supply channel 2, which extends substantially along a portion of the length of the catheter 100, is in communication with each of the spacer balloons 4 via one of the respective outlets 13, 14 provided in the body of the catheter 100 (eg, Figure 2 As shown), and connected to the side terminal 10 of the three-way connector 12, wherein the supply channel 2 has an inlet hole or an inlet corresponding to the opening in the side terminal 10 provided at the proximal end of the catheter 100. When the catheter 100 is inserted into the lumen of the patient's hollow organ, the inlet of the supply channel 2 is positioned outside the patient's body to communicate with the surrounding atmosphere or environment. Therefore, 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 gaseous medium or fluid (e.g., air or water) can initially be supplied to the side terminal 10 from the second functional device under pressure in a given volume through the hole made therein, then supplied from the side terminal 10 to the supply channel 2, and finally supplied from the supply channel 2 to the two isolation balloons 4 through the corresponding holes made in the catheter body 100, thereby inflating or filling the isolation balloons 4 with water or gas by using, in particular, the supply channel 2 of the catheter 100 to provide an overall filled or inflated balloon 4, each balloon having an increased size or volume. One skilled in the art can select the pressure for filling or inflating the isolation balloon 4 with a fluid or gas for any particular hollow organ based on information disclosed in prior art documents (eg, US Pat. No. 7,722,568).

[0083] It is to be noted that the increase in the size or volume of the isolation balloon 4 results in bilateral closure or obstruction of the lumen of the patient's hollow organ (e.g., the lumen of the duodenum of the patient in which the catheter 100 is inserted), thereby allowing the portion of the catheter 100 having the functional opening 7 to be isolated between the inflated isolation balloons 4 in the patient's hollow organ. Therefore, the inflated isolation balloons 4 allow a portion of the patient's hollow organ, such as the large and small duodenal papillae of the duodenum, an aneurysm, a wall defect of the hollow organ, etc., to be isolated from the proximal and distal portions of the hollow organ, and, therefore, they exclude or prevent the target biological fluid from mixing with other biological fluids, and allow the catheter 100 to be fixed in the lumen of the patient's hollow organ, such as in the lumen of the duodenum of the patient, because the outer side of the balloon 4 is in close proximity to the inner wall surface of the hollow organ. In particular, when the catheter 100 is inserted into the lumen of the duodenum, the inflated isolation balloon 4 allows the small duodenal papilla and / or large duodenal papilla of the patient's duodenum to be isolated from the proximal and distal portions of the gastrointestinal tract, and thus, prevents the target biological fluid, which may be a mixture of pancreatic juice and bile, from mixing with other biological fluids (such as gastric juice and contents and / or duodenal contents). This ensures that the digestive enzymes contained in the pancreatic juice remain inactive.

[0084] In one embodiment of the present invention, the spacer balloons 4 can be connected between these spacer balloons through the supply channel 2, thereby ensuring uniform redistribution of the liquid or gaseous medium used to expand or inflate the spacer balloons, for example, during the passage of peristaltic waves in the intestine or esophagus. In another embodiment of the present invention, the spacer balloons 4 can be formed as, for example, self-expanding balloons, or balloons inflated by air supplied to the supply channel 2 of the catheter 100 through the holes in the side terminal 10 of the three-way connector 12, or balloons inflated in any other manner known in the art.

[0085] In one embodiment of the present invention, the side terminal 10 in the three-way connector 12 can be optionally equipped with a manually operated stop valve (not shown) to prevent the backflow or escape of the gaseous medium or fluid (especially the gas or water located in the isolation balloon 4, the supply channel 2 and the side terminal 10). It should also be noted that the isolation valve can be used by the catheter user to adjust the degree of inflation of the isolation balloon 4, wherein the user can visually control the degree of inflation by using an endoscope. In particular, the user can reduce the size or volume of the inflated isolation balloon 4 by manually opening the check valve to deflect or discharge the gaseous medium or fluid, especially gas or water, from the supply channel 4.

[0086] The functional channel 3 extending substantially along a partial length of the catheter 100 is in communication with the side terminal 8 of the three-way connector 12, wherein the functional channel 3 has an inlet or an inlet port corresponding to the functional opening 7, and an outlet or an outlet port corresponding to the opening in the side terminal 8 provided at the proximal end of the catheter 100. Therefore, in the case where the above-mentioned third functional device (not shown) is implemented as an aspirator connected to the side terminal 8 of the three-way connector 12, the functional channel 3 will basically serve as a suction channel, and the functional channel 3 will basically serve as a suction opening, wherein a negative air pressure or a negative air medium pressure will be generated or supported inside the hollow organ, the interior of the hollow organ being isolated by the isolation balloon 4 inflated as described above. The negative pressure (also referred to in the art as a technical vacuum) generated in the isolated interior of the patient's hollow organ promotes the drainage or removal of biogas media or biofluids, in particular bioliquids (such as bile and pancreatic juice or pancreatic secretions or pus, or blood, or bronchial secretions), first from the isolated interior through the functional opening 7 to the functional channel 3, then from the functional channel 3 to the side terminal 8, and finally from the side terminal 8 to the storage container of the aspirator through the corresponding holes made in the side terminal 8. It should be noted that the functional channel 3 with the functional opening 7 can be used not only for sampling biogas media or biofluids that are specific to a specific hollow organ, but also for supplying the required liquid or gaseous media, such as drugs or colorants in liquid or gaseous form, to the isolated interior in the case where the above-mentioned third functional device (not shown) is realized as a device for supplying gaseous media or fluids (for example, a medical syringe or a medical dropper) connected to the side terminal 8 of the three-way connector 12, and the required liquid or gaseous media is supplied to the isolated interior.

[0087] It should be noted that the aspirator is one possible embodiment of the above-mentioned third functional device that can be connected to the side terminal 8 of the three-way connector 12, and when the aspirator is activated by the user, an air compressor that is part of the aspirator is activated. The activated air compressor provides suction or discharge of air medium or air from the interior of the patient's hollow organ, for example, from the interior of the patient's duodenum isolated by the inflated isolation balloon 4 in the above-mentioned manner, and from the available space in the aspirator storage container, which is not filled with biological gaseous medium or biological fluid (for example, biological fluid, such as bile and pancreatic juice, or pancreatic secretions) to generate negative pressure in the isolated interior of the hollow organ (for example, in the lumen of the patient's duodenum), thereby obtaining biological medium through the functional opening 7 and removing or supplying the obtained biological medium to the storage container through the functional channel 3 for accumulation or collection in the storage container for a predetermined period of time.

[0088] It should be noted that in one of these embodiments, the side terminal 8 of the three-way connector 12 can be used to manage the passage of liquid or gaseous substances carried by the functional channel 3 and entering the interior between the isolation balloons 4 through the functional openings 7. The administered gaseous or liquid substances (such as drugs or colorants) can affect the area of ​​the hollow organ isolated by the balloon 4 and have a diagnostic and / or therapeutic effect on this area.

[0089] In one embodiment of the present invention, only the above-mentioned supply channel 2 for supplying fluid (for example, water) to the isolation balloon 4 connected to the above-mentioned side terminal 10 and the above-mentioned functional channel 3 connected to the above-mentioned side terminal 8 can be set in the catheter body 100.

[0090] In addition, the body of the catheter 100 is provided with two substantially identical protrusions 6 on its outer side, each of which is formed as an annular protrusion or ring, and the annular protrusion or ring has a radius greater than the radius of the body of the catheter 100 or less than the radius of any of the inflated isolation balloons 4, wherein each of the protrusions 6 is positioned on a side adjacent to or close to the functional opening 7 along the length of the body of the catheter 100, and wherein the protrusions 6 are preferably equidistantly spaced between the isolation balloons 4 relative to the functional opening 7. It should be noted that, in the case where the catheter 100 is inserted into the lumen of the patient's hollow organ, the ridge 6, which is basically the protruding side surrounding the functional opening 7, prevents the functional opening 7 from contacting the mucosa of the patient's hollow organ or approaching the mucosa of the patient's hollow organ by a distance suitable for suctioning the mucosal tissue into the functional opening 7 when the aspirator connected to the functional channel 3 of the catheter 100 is activated by the user, and thus, when negative pressure is provided by the aspirator in the isolated interior in the lumen of the hollow organ, the mucosal tissue of the hollow organ is damaged. In one embodiment of the present invention, the ridge 6 may have any other form other than a ring or annular form, as long as such form prevents the functional opening 7 from contacting the mucosa of the patient's hollow organ or preventing the functional opening 7 from approaching the mucosa of the patient's hollow organ by a distance suitable for suctioning the mucosa into the functional opening 7 when negative pressure is generated in the isolated interior of the hollow organ connected to the functional opening 7.

[0091] In addition, if Figure 3-Figure 4As shown, the body of the catheter 100 is provided with two protrusions or projections 15 at its outer side, wherein each of these projections 15 is arranged at a predetermined distance from one of the corresponding balloons 4 on the outer side of the catheter body portion defined by the isolation balloon 4, wherein an elastic net or mesh shell 16 is attached to the projections 15 to completely or at least partially cover the isolation balloon 4 and a portion of the body of the catheter 100 defined by the balloon 4, thereby completely or at least partially enclosing or covering the functional opening 7. When the balloon 4 is inflated, as shown in FIG. Figure 4 As shown, the mesh shell 16 becomes taut or stretched, thereby moving or displacing the inner wall tissue in the hollow organ by a predetermined distance from the functional opening 7. The mesh shell 16 in a fully or at least partially strained state forms an elastic outer shell or frame that fully or at least partially surrounds the catheter body portion defined by the balloon 4 or positioned between the balloons 4, thereby fully or at least partially enclosing or covering the functional opening 7. The outer frame formed by the mesh shell 16 has a cylindrical shape and is permeable to liquids due to its cellular structure, thereby allowing biological fluids specific to a certain hollow organ of a mammal to penetrate or pass through the material of the mesh shell 16 and enter the functional opening 7. In particular, when a suction device (not shown) is connected to the side terminal 8 to provide negative pressure in the isolation area between the isolation balloons 4 through the functional channel 3 and the functional opening 7 in the catheter 100, the stretched or tightened mesh shell 16 will hinder the adhesion or adhesion of the inner wall tissue in the hollow organ (e.g., blood vessel wall, intestinal mucosa, bronchi, stomach, ureter, etc.) to the functional opening 7, thereby allowing biological materials or biological fluids (e.g., bile, pancreatic juice, bronchial secretions, etc.) to be continuously drawn into the container of the suction device.

[0092] In one embodiment of the present invention, the mesh shell 16 can be attached to the two isolation balloons 4 so that the mesh shell completely or at least partially surrounds the catheter body portion defined by the balloons 4 or positioned between the balloons 4, thereby completely or at least partially enclosing or covering the functional opening 7. When the balloons 4 are inflated, as Figure 4 As shown, the mesh shell 16 becomes taut or stretched, thereby allowing the inner wall tissue in the hollow organ to be removed or displaced at a predetermined distance from the functional opening 7 .

[0093] In another embodiment of the present invention, the mesh shell 16 can be formed as a mesh material or net that is initially fixed on the protrusion 6 in a strained state or at least partially strained state, so that the mesh shell completely or at least partially surrounds the catheter body portion defined by the balloon 4 or positioned between the balloons 4, thereby completely or at least partially enclosing or covering the functional opening 7.

[0094] In some other embodiments of the present invention, the mesh shell 16 can be fixed to the body of the catheter 100 in an initial strained state by any suitable fastening method known in the art, so that the mesh shell completely or at least partially surrounds the catheter body portion defined by the balloon 4 or positioned between the balloons 4, thereby completely or at least partially enclosing or covering the functional opening 7.

[0095] In other embodiments of the present invention, the mesh shell 16 may have any form that allows the mesh shell 16 to be fixed to the body of the catheter 100 , the protuberance 6 , or the isolation balloon 4 to completely or at least partially enclose or cover the functional opening 7 .

[0096] In addition, three auxiliary holes 5.1, 5.2 are arranged in the catheter body 100 outside the spacer balloon 4, and therefore outside the catheter body part provided with the functional opening 7 and defined by the spacer balloon 4. When the catheter 100 is inserted into the lumen of the patient's hollow organ, the auxiliary hole 5.2 located farther from the distal end of the catheter 100 is used as an inlet, and the auxiliary hole 5.1 located closer to the distal end of the catheter 100 is used as an outlet. It should be noted that the auxiliary holes 5.1, 5.2 allow the contents of the hollow organ (e.g., air, urine, blood, gastric or intestinal contents with inactive digestive enzymes) to pass through the distal section of the hollow organ without entering the area defined by the inflated spacer balloon 4 of the catheter 100, thereby preventing or eliminating the formation of congestion and / or inflammatory processes in the patient's hollow organ, which are particularly caused by the accumulation of blood, urine, air, mucus and other contents outside the inflated spacer balloon 4, in the patient's hollow organ located farther or furthest from the distal end of the catheter 100.

[0097] The position of the holes may vary depending on the purpose of the catheter 100 according to 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 position and diameter of the spacer balloon 4 in the catheter 100. A person skilled in the art can easily adjust any parameter of the catheter 100 depending on the size of a specific hollow organ.

[0098] The thickness of the channel of the catheter 100 and the size of the isolation balloon 4 can be adjusted by a person skilled in the art based on the information disclosed in the art (e.g., U.S. Patent No. 9526874, U.S. Patent No. 6692465, U.S. Patent No. 5843050, U.S. Patent No. 5919163, International Publication WO2009 / 035581, U.S. Patent No. 5397305, U.S. Patent No. 8398589, U.S. Patent No. 7722568, U.S. Patent No. 6712798, U.S. Patent No. 6638245, U.S. Patent No. 1009865 and / or other prior art information sources).

[0099] 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 can be matched by a person skilled in the art based on information disclosed in the art (e.g., US Patent No. 5314409, US Patent No. 5658264, US Patent Application No. 20150150572, US Patent No. 5843050, US Patent No. 5397305, US Patent No. 7070606, US Patent No. 6712798, US Patent No. 1009865 and / or other prior art information sources).

[0100] For example, in one preferred embodiment of the preferred embodiments of the present invention, the catheter 100 can be implemented as a pancreatic digestive catheter and can have a length of 130 cm. In this embodiment of the present invention, the respective distances of the isolation balloon 4 from the distal end of the catheter 100 are 15 sm and 25 sm, respectively, which is used to insert the catheter 100 into the lumen of the stomach cavity and the duodenum of the patient, so that the expansion or inflation of the isolation balloon 4 allows the isolation area of ​​the duodenum to have a length of at least 10 cm. In this embodiment of the present invention, the functional opening 7 can be in the middle between the isolation balloons 4, that is, at a distance of 5 cm from each of the isolation balloons 4 and at a distance of 20 cm from the distal end of the catheter 100.

[0101] The use of the catheter 100 according to the present invention for isolating the area in the hollow organ of the patient is schematically described above about the duodenum of the patient. However, the use of the catheter 100 is not limited by the duodenum of the patient. Therefore, it is clear to those skilled in the art that the catheter 100 according to any embodiment in the above-mentioned embodiments can be similarly inserted into the lumen of any other hollow (tubular) internal organ of the patient (particularly mammal), for example, inserted into the esophagus, stomach, duodenum, small intestine, large intestine, respiratory tract, urinary tract (urogenital system), vein, artery, vagina, uterus, uterine (fallopian tube) tube, spinal canal or any appropriate internal tubular organ of the patient, and the patient's tubular organ is related to the corresponding functional system (organ system) of the mammalian organism, and these functional systems are from a group of systems, including: digestive system, respiratory system, urinary and reproductive system (combined into urogenital system or genitourinary system), endocrine system, circulatory system and immune system and skeletal system.

[0102] Therefore, when in use, the catheter 100 according to the present invention can be inserted into the lumen of the duodenum of a patient by a user under the control of an endoscope (not shown) or a radiographic device (e.g., a fluoroscopic device), so that one of the corresponding isolation balloons 4 that is farthest from the distal end of the catheter 100 is positioned in the bulb of the duodenum of the patient, wherein the endoscope can be manipulated by the user or an endoscopist assisting the user. It is particularly noted that the process of inserting the catheter 100 into the lumen of the duodenum of the patient, the process of removing the catheter 100 from the lumen of the duodenum of the patient after sampling the required amount of biological fluid, and the suction process are non-destructive and do not rely on the anatomical features of both the patient and the tumor. It should be noted that when the user inserts the catheter 100 into the lumen of the duodenum of the patient, the isolation balloon 4 is in a deflated state.

[0103] According to one example, the catheter 100 may be pre-equipped with at least one loop designed to be grasped with a biopsy forceps. In order to insert the catheter 100 into the desired placement site in the duodenum of the patient, the distal end of the catheter 100 fully lubricated with petroleum jelly is applied through the nasal passage and advanced into the gastric cavity; then the endoscope is further applied or advanced through the patient's oral cavity to the patient's gastric cavity in parallel with the catheter 100 to capture the (multiple) loops of the catheter 100 by the endoscopic biopsy forceps; finally, the captured catheter 100 is guided or advanced into the duodenum of the patient together with the endoscope. Subsequently, under the control of the endoscope, one of the corresponding isolation balloons 4 of the catheter 100, which is farthest from the distal end of the catheter 100, is placed in the bulb of the duodenum of the patient.

[0104] According to another example, a metal guide wire may be pre-applied or inserted into the main channel 1 of the catheter 100. In order to insert the catheter 100 into the desired placement site in the duodenum of the patient, the distal end of the catheter 100 fully lubricated with petroleum jelly is inserted through the nasal passage and then pushed into the gastric cavity by using the metal guide wire of the catheter 100; then the endoscope is inserted or pushed through the patient's oral cavity to the patient's gastric cavity in parallel with the catheter 100 to capture the first ligature by the endoscopic biopsy forceps when the distal end of the catheter 100 is detected, and the catheter 100 is pressed toward the endoscope by pulling the catheter 100 upward by using the captured first ligature. Subsequently, the endoscope and the catheter 100 pressed against the endoscope are guided through the pylorus to the duodenum of the patient, and one of the corresponding spacer balloons 4 of the catheter 100, which is farthest from the distal end of the catheter 100, is placed in the bulb of the duodenum of the patient under endoscopic control.

[0105] Then, the user connects or attaches the above-mentioned second functional device (not shown) to the side terminal 10 of the three-way connector 12, at which time the second functional device is intended to supply a liquid or gaseous medium (e.g., gas or water) in a desired amount or volume, particularly 40-70 ml of water, to the supply channel 2 of the catheter 100 to allow the expansion and inflation of the isolation balloon 4 to tightly couple to the mucosa of the duodenum, thereby isolating the desired area of ​​the duodenum of the patient including the major and minor duodenal papillae, particularly preventing gastric contents and / or duodenal contents with inactive digestive enzymes from entering the isolated area. It is particularly noted that, as an illustrative example, the results obtained by the inventor through experiments indicate that 40-70 ml of air is required to fully inflate the isolation balloon 4 to the size required for the lumen of the duodenum of the patient into which the bilateral closure or occlusion catheter 100 can be inserted.

[0106] The user then combines or connects the above-mentioned third functional device (not shown) implemented as an aspirator to the functional channel 3, wherein the aspirator is preliminarily configured for a constant or variable operating mode that provides the required working pressure according to the specific task. The aspirator activated by the user allows the suction of an air medium or air from the isolated interior of the duodenum of the patient through the functional opening 7 and the functional channel 3 connected to the functional opening, the isolated interior corresponding to the periampullary region of the duodenum, thereby generating a negative pressure corresponding to the pressure usually generated by duodenal peristalsis, in particular a negative pressure of 40-100 mm H2O (9-14 kPa)). The negative pressure provided in the isolated interior of the duodenum of the patient allows the biological fluid in the form of pancreatic juice or pancreatic secretions combined with bile to be discharged or retrieved from the pancreas through the large and small duodenal papillae, thereby removing the biological fluid from the isolated area of ​​the duodenum of the patient through the functional opening 7 and the functional channel 3, and collecting the biological fluid in a storage container (not shown) of the aspirator. In some cases, the container may further collect mucosal secretions from the bile duct and pancreatic duct, which is one of the multiple biological fluids unique to the duodenum, and / or some biological content (which enters the bile duct and pancreatic duct due to reflux and will contain fluids produced by organisms that are specific to the human duodenum). Subsequently, the biological fluid collected in the storage container of the functional device (not shown) can be transported for cytological examination and / or molecular genetic examination or other analysis to evaluate the morphological and structural characteristics of the cellular components of the pancreatic secretions, which allow one to detect or reveal specific pathological processes such as intraductal tumors, neuroendocrine tumors or pancreatic cancer, and detect tumors at an early stage of development, and 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, miRNA21 and miRNA155).

[0107] In addition, 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) can be connected to the functional channel 3 to achieve delivery of the desired fluid or gaseous medium (e.g., a drug in liquid or gaseous form) to the isolated interior of the patient's duodenum.

[0108] It should be noted that the catheter 100 according to the present invention can be maintained in an inserted state for a sufficiently long period of time, for example up to 7 days (i.e. up to 168 hours), thereby allowing the collection of pancreatic secretions in appropriate quantities for reliable identification and verification of pathological tumor materials, thereby substantially improving the diagnostic efficiency and thus the subsequent treatment of pancreatic cancer. In addition, extended sampling increases the possibility of detecting pathological cells and other biomarkers that can be used not only for pancreatic cancer, but also for malignant diseases of the bile duct and liver (including cholangiocarcinoma and / or hepatocellular carcinoma).

[0109] It should also be noted that when using the catheter 100, there is no need to stimulate the secretion of pancreatic juice and bile, so the collected biological material has real biochemical and physiological indicators, showing the real functional status of the pancreas, liver, bile duct and gallbladder contractility.

[0110] If desired, the excretory function of the pancreas can be evaluated by examining the biochemical composition of the pancreatic secretions combined with bile collected in the above-described manner in a storage container (not shown) using the catheter 100 according to the present invention.

[0111] Furthermore, qualitative and quantitative analysis of pancreatic juice and bile allows the assessment of real biochemical indicators of biological material and daily secretion, thus diagnosing the functional status of the organs.

[0112] The catheter 100 according to any of the above-described embodiments of the present invention can be used to diagnose or monitor the development of at least one disease selected from the group consisting of gastritis, pancreatitis, pancreatic cancer, bile duct cancer, cholangiocarcinoma, hepatocellular carcinoma, cholangitis, cholelithiasis, hollow organ wall defects, autoimmune hepatitis, infectious hepatitis, aneurysm or diverticulum protrusion of the hollow organ wall, internal bleeding in a hollow organ, stenosis of a hollow organ and esophageal neuromuscular disorders, abnormalities of the stomach, duodenum, small and large intestines, bile duct, urinary system and respiratory tract.

[0113] In addition, the catheter 100 in any of the above-mentioned embodiments of the present invention can be used to treat at least one disease selected from the group consisting of pancreatitis, cholangitis, gastrointestinal wall defects, hemangiomas, venous thrombosis, ureteral defects, respiratory tract defects, gastrointestinal bleeding, tracheal (laryngeal) bleeding, bronchial bleeding, pulmonary bleeding and uterine bleeding.

[0114] Furthermore, the catheter 100 according to any of the above-described embodiments of the present invention may be used to isolate an area of ​​a blood vessel, particularly an area of ​​tissue with respect to the inner wall of a blood vessel, when performing a surgical procedure or performing a surgical manipulation.

[0115] In particular, when using the catheter 100, a therapeutic or therapeutic effect is achieved by restoring and promoting the drainage 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 impairment or interruption of pancreatic juice and bile outflow, and the outflow impairment is particularly caused by impaired motility (peristalsis) of the duodenum of mammals, so the isolated area with controllable negative pressure (e.g., 40-100mm H2O) generates pancreatic juice and bile suction by using the catheter 100, allowing people to solve this medical problem, thereby helping to treat the above-mentioned acute diseases.

[0116] In addition, when using catheter 100, a therapeutic or therapeutic effect is achieved by draining contents from an area associated with a defect in the gastrointestinal wall, thereby providing an isolation zone with a controllable negative pressure (e.g., between 70-100 mm of water) allowing one to drain all biological fluids from the defect area and resolve the medical problem, thereby helping to resolve the patient's medical problem.

[0117] It is clear to those skilled in the art that the catheter 100 according to the present invention can be made of any suitable material based on the information disclosed in the prior art (eg, US Pat. No. 7,722,568 or US Pat. No. 6,638,245), wherein the catheter 100 can preferably be made of a polymeric material.

[0118] Example

[0119] Example No. 1. Patient No. 1 was admitted to the hospital with band-like pain in the upper abdomen. The amylase in the blood was 1150 U / L. The results of the ultrasound examination were as follows: the size of the pancreas was increased; the head was 35 mm; the body was 32 mm; the tail was 21 mm; there was strong heterogeneity; the contours were unclear; the parapancreatic tissue was edematous; no fluid was detected. The MSCT picture corresponded to acute edematous pancreatitis. The patient started treatment according to the recommendations of the Russian Association of Surgeons, in which a catheter 100 according to the invention was inserted into the patient's duodenum for 24 hours, and active suction was performed. After 24 hours, the level of amylase in the blood dropped to 230 U / L, and the pain syndrome was controlled.

[0120] Example No. 2. Patient No. 2 was admitted to the hospital due to clinical manifestations of obstructive jaundice. Examination showed that the level of white blood cells was elevated to 14.1×109, with total bilirubin of 145mmol / L and direct bilirubin of 113.2mmol / L. Amylase in the blood was 57U / L, alanine aminotransferase (ALT) was 391U / L, and aspartate aminotransferase (AST) was 90U / L. The results of ultrasound examination were as follows: multiple stones with a diameter of up to 1.3cm were detected in the gallbladder, and the bile duct was dilated to 11mm. The results of magnetic resonance imaging (MRI) were as follows: a shadow corresponding to a 6mm stone was detected in the distal part of the common bile duct. The results of endoscopic retrograde cholangiopancreatography (ERCP) were as follows: a single 8mm stone was found and then removed endoscopically. In order to prevent acute pancreatitis, the catheter 100 according to the present invention was inserted into the patient's duodenum for 24 hours, and active suction was performed. During the postoperative period, the increase in blood amylase levels did not exceed 87 U / L.

[0121] Example No. 3. Patient No. 3 was admitted for routine examination and treatment. A previously performed MSCT detected the formation of an anomalous body in the pancreas. Endoscopic ultrasound detected the formation of an anomalous body with a size of 2 cm×3 cm, where a fine needle biopsy was technically impossible. In order to selectively sample the pancreatic juice, a catheter 100 according to the present invention was inserted into the duodenum of the patient. In the pancreatic juice obtained for cytological and molecular examinations, mutations in adenocarcinoma cells and driver genes, exosomes and protein markers were detected.

[0122] Example No. 4. Patient No. 4 was admitted to the hospital with clinical manifestations of obstructive jaundice. The results of MRI were as follows: a mass was found at the confluence of the left and right hepatic ducts of the liver lobe, which mass corresponds to type IIA hilar cholangiocarcinoma (Klatskin tumor). The catheter 100 for isolating a region in a hollow organ according to the present invention was inserted into the duodenum of the patient, and active suction was performed. In the bile obtained by cytological and molecular examinations, markers of abnormal cells and malignant tumors were detected.

[0123] Example No. 5. Patient No. 5 was diagnosed with chronic pancreatitis. Although the patient received treatment from a gastroenterologist and was prescribed enzyme drugs, weight loss, bowel movement disorders and diarrhea were observed. In order to evaluate the functional state of the pancreas, a catheter 100 for isolating an area in a hollow organ according to the present invention was inserted into the duodenum of the patient for 24 hours, and active suction was performed. As a result of biochemical tests performed on the obtained pancreatic juice, it was found that the levels of α-amylase and lipase were reduced, and it was also found that the daily excretion of pancreatic juice and bile was reduced. As a result, the dose of enzyme drugs taken by the patient was increased, and ursodeoxycholic acid drugs and bile substitutes were additionally prescribed.

[0124] Example No. 6. Patient No. 6 was admitted to the city's infectious disease clinic with jaundice. Physical examination showed an enlarged liver, among which the biochemical blood test results showed the following: total bilirubin 329mmol / L, direct bilirubin 141mmol / L, ALT 1040U / L, AST 804U / L. Serological analysis of HCV antigens in the blood, HBsAg was negative. A catheter for isolating the area in the hollow organ was inserted into the patient's body, and 100ml of bile was obtained by active suction in vivo. A high copy number of the HCV virus was detected by PCR analysis of the bile.

[0125] Example No. 7. Patient No. 7 was treated in the infectious disease clinic for confirmed viral hepatitis. After a course of interferon therapy, repeated PCR analysis of the blood revealed no active viral process. A catheter 100 for isolating an area in a hollow organ was inserted into the patient, 200 ml of bile was obtained in vivo by active aspiration, and PCR analysis of the bile obtained revealed an ongoing viral process, so the treatment regimen and duration were changed.

[0126] Example No. 8. Patient No. 8 was diagnosed with intestinal fistula and peritonitis. Surgery, sanitization and drainage of the abdominal cavity were performed in an emergency. In order to isolate the intestinal wall defect, reduce its contact with the intestinal contents, improve the healing process, and also to provide an additional way to treat peritonitis by separating the abdominal cavity and the pathological matrix, the catheter 100 for isolating the area in the hollow organ according to the present invention was inserted into the damaged area of ​​the intestine so that the isolation balloon 4 was positioned above and below the defect. After inflating the balloon, an isolation area was created and another channel was connected to a suction device to provide sanitization to the intestinal fistula area to promote defect healing. Enteral nutrition was also administered to the patient through the catheter 100.

[0127] Example No. 9. Patient No. 9 was rushed to the hospital due to band-like pain in the abdomen. Based on the results of the examination, the patient was diagnosed with moderate acute pancreatitis according to the Atlanta classification. On admission, the amylase level was 1320 U / L. The catheter 100 for isolating an area in a hollow organ according to the present invention was inserted into the patient's body, and the functional channel in the body was connected to a pump for generating a controllable negative pressure, while enteral nutrition and medical products were administered to the patient through the same catheter 100. As a result, the dynamics of the biochemical parameters turned positive according to the BISAP scale within 24 hours, and the patient recovered after 7 days.

[0128] Example No. 10. Patient No. 10 was rushed to the hospital due to right flank pain, hot flashes, and periodic yellowing of the skin. Past medical records showed that 3 months before the current hospitalization, the patient underwent endoscopic manipulation related to the bile duct to remove stones from the bile duct. Ultrasound and MSCT showed no changes in the liver, ducts, or the presence of abscesses. In order to diagnose cholangitis, a catheter 100 for isolating areas in the hollow organ was inserted into the patient's body, and 50.0 ml of bile was sampled for bacteriological examination. As a result, a large growth of Klebsiella was found, and its sensitivity to antimicrobial drugs was determined. After the selection of specific antibiotic treatment, the symptoms of cholangitis disappeared and the patient was discharged for outpatient treatment.

[0129] Example No. 11. Patient No. 11 underwent a sigmoid colectomy due to the presence of a mass. During intestinal mobilization, it was discovered that a structure had invaded all layers of the intestine, with regional lymphadenopathy and involvement of the retroperitoneal tissue. When the tumorous intestine was mobilized, a connection was established with the damaged ureter of the left kidney. The urologist was called to the operating room and the defect of the ureter was treated surgically. In order to prevent complications, a sized catheter 100 for isolating an area in a hollow organ according to the present invention was applied retrograde over the guide wire, and one of the balloons was inflated in the pelvis of the left kidney, while the other balloon (the lower balloon) was inflated in the bladder, with a functional channel connected to a suction device for generating a controllable negative pressure. The catheter 100 was removed within 14 days, and the excretory function of the left kidney was not impaired. The patient was discharged for outpatient treatment.

[0130] Example No. 12. Patient No. 12 was admitted to the hospital due to pulmonary hemorrhage. Bronchoscopy revealed a putrefactive hemorrhagic tumor in the right main bronchus. For the purpose of hemostasis and maintaining bronchial patency, as well as to prevent incomplete expansion of the lung, a catheter 100 for isolating an area in a hollow organ according to the present invention was applied to the right bronchus. The catheter 100 was inserted so that the tumor was located between the balloons, wherein the inflation of the balloons prevented blood from flowing to other parts of the bronchus. In order to stop the bleeding, a hemostatic agent was applied through the functional channel of the catheter 100. As a result, there was no recurrence of bleeding after three (3) days of observation. The catheter 100 was subsequently removed. Ten (10) days later, the patient was discharged to receive outpatient treatment.

[0131] Example No. 13. Patient No. 13 was admitted to the hospital urgently with mediastinitis confirmed by clinic instruments. Examination revealed that the esophageal defect was caused by necrosis caused by a piece of meat. In order to treat the esophagus, a catheter 100 for isolating an area in a hollow organ according to the present invention was inserted. The balloon of the catheter 100 was inflated to isolate the defect, and the functional channel was connected to a suction device to provide controlled negative pressure. As a result, the patient was discharged from the hospital for outpatient treatment after 1.5 months.

[0132] Example No. 14. Patient No. 14 was admitted urgently with headache and general cerebral symptoms. MSCT with intravenous contrast enhancement showed an aneurysm in the basin of the right middle cerebral artery with signs of compression. The patient was taken to the angiographic operating room, where the catheter 100 according to the present invention for isolating an area in a hollow organ was administered via the femoral approach. Positioning of the catheter 100 was performed under fluoroscopic control so that the balloon isolated the area of ​​the aneurysm, with the functional channel opposite the aneurysm. A filling solution filling the aneurysm cavity was administered through the functional channel. After the necessary exposure, the catheter 100 was allowed to maintain circumferential blood flow. The catheter 100 was subsequently removed. The patient was discharged after 21 days.

[0133] Example No. 15. Patient No. 15 was admitted for conventional surgical treatment of pancreatic cancer. Examination showed that the head tumor invaded the inferior vena cava. In order to reduce blood loss, the catheter 100 for isolating the area in the hollow organ according to the present invention was inserted into the vein, and the balloon was inflated above and below the pancreatic head tumor, thereby shunting the blood and returning it to the heart. During the gland removal, a part of the inferior vena cava was removed with the lower limb saphenous vein autoplasty. The blood loss was 500 ml. Thus, optimal temporary and physiological conditions were created for both the patient and the surgeon.

[0134] Example No. 16. Patient No. 16 was admitted for surgical treatment of sigmoid colon cancer. After surgery, the patient had a failed colo-rectoanastomosis at 1 / 3 of the circumference. In order to treat the colon, a catheter 100 for isolating an area in a hollow organ according to the present invention was retrogradely inserted into the rectum so that one balloon of the catheter 100 was positioned at the most proximal side relative to the defect and the other balloon of the catheter 100 was positioned at the most distal side relative to the defect. When the balloon of the catheter 100 was inflated, the defect area was isolated from the rest of the large intestine. Due to the main channel, the proximal part of the intestine was cleaned with water. As a result, the defect was closed within 3 weeks.

[0135] Example No. 17. Patient No. 17 was admitted to the hospital due to a suspected liver tumor. In order to perform a liquid biopsy, a catheter 100 according to the present invention for isolating an area in a hollow organ was inserted; the area associated with the major and minor duodenal papillae was isolated by the balloon of the catheter 100, and bile aspiration began. When the catheter 100 was removed, the bile aspirate was delivered for genetic and cytological examinations, in which no pathological markers and cells were detected. When the bile was taken, the sock covering the balloon of the catheter 100 was removed and washed with buffer, whereupon the water was collected and a cell precipitate was obtained after centrifugation. Cytological examination of the obtained cell precipitate revealed the presence of hepatocellular carcinoma cells.

[0136] Example No. 18. Patient No. 18 was admitted urgently for uterine bleeding. Colposcopy revealed a rotten cervical cancer. To stop the bleeding, the catheter 100 was inserted into the vagina and uterine cavity, and the tumor area was isolated by the balloon of the catheter 100. The tumor was instilled with a hemostatic drug through the functional channel of the catheter 100. The bleeding was stopped and the patient was discharged.

[0137] Thus, the catheter 100 described above allows functional studies to be performed or carried out on any hollow organ, and also allows appropriate treatment to be provided. In addition, the examination and / or laboratory analysis of biological fluids collected by using the catheter 100 allows one to distinguish and diagnose inflammatory formations, benign formations and malignant growths, and infectious diseases with high accuracy. By draining specific fluids, the catheter 100 allows the treatment of inflammatory diseases, bleeding, and defects in the walls of hollow organs. The creation of an isolated area with a bypass function during surgical procedures allows one to control hemostasis, and also to perform surgical procedures, in particular the removal of vascular sites and their subsequent angioplasty. It should also be noted that the catheter 100 according to the present invention or the above-mentioned system for isolating an area in a hollow organ of a mammal (not shown) can include a catheter 100 that provides the ability to collect a large amount of biological material in a normal physiological and biochemical state without additionally stimulating the excretion function of the hollow organ of the organ connected to the hollow organ, in particular due to the generation of a negative pressure corresponding to the physiological negative pressure that may be generated, for example, due to the peristalsis of the intestine, in the isolated area of ​​the hollow organ (the catheter 100 is inserted into the lumen of the hollow organ).

Claims

1. A catheter (100) for isolating the interior of a hollow organ of a mammal, the catheter comprising: - an elongated catheter body, the catheter body being designed to be inserted into the lumen of a hollow organ of the mammal; - two balloons (4) disposed individually and separately along the catheter body and configured to be inflated to isolate the interior of the mammalian hollow organ between the balloons; as well as a functional channel (3) extending in the catheter body and comprising a functional opening (7) arranged in the catheter body between the balloons (4), Wherein, the functional channel (3) is designed to allow: - generating a negative pressure in the insulated interior in order to extract a liquid or gaseous medium from the insulated interior via the functional opening (7); and / or - supplying a liquid or gaseous medium into the insulating interior via the functional opening (7); and a second channel extending in the body provided with an inlet and an outlet at opposite ends, the inlet and the outlet being arranged in the catheter body outside the isolated interior defined by the balloon (4), Characterized in that the catheter body of the catheter (100) is further provided with: A net or shell (16) which is permeable to liquid and / or gaseous media, wherein the net or shell (16) at least partially surrounds the catheter portion defined by the balloon (4) so ​​as to cover the functional opening (7); and wherein the net or shell (16) is attached to the balloon (4) or surrounds the balloon so that the net or shell (16) becomes taut when the balloon (4) is inflated.

2. The catheter (100) according to claim 1 further comprises an inflation channel (2), wherein the inflation channel extends in the catheter body to deliver a liquid or gaseous medium to the balloon (4) to inflate the balloon.

3. The catheter (100) according to any one of claims 1 to 2, wherein: The second channel is also configured to supply liquid to the catheter and is also provided with an additional outlet, which is provided at the distal end of the catheter, and the distal end of the catheter is used to insert the catheter (100) into the lumen of the hollow organ of the mammal.

4. The catheter (100) according to claim 2, wherein: Each of the functional channel (3), the second channel and the expansion channel (2) are sealed and isolated from each other.

5. The catheter (100) according to any one of claims 1, 2 and 4, wherein: Two annular protrusions surrounding the functional opening (7) are also provided on the catheter body, between the balloons (4), so that the functional opening (7) is located between and adjacent to the annular protrusions.

6. A catheter (100) for isolating the interior of a hollow organ of a mammal, the catheter comprising: - an elongated catheter body, the catheter body being designed to be inserted into the lumen of a hollow organ of the mammal; - two balloons (4) disposed individually and separately along the catheter body and configured to be inflated to isolate the interior of the mammalian hollow organ between the balloons; as well as a functional channel (3) extending in the catheter body and comprising a functional opening (7) arranged in the catheter body between the balloons (4), The functional channel (3) is designed to allow: generating a negative pressure in the isolated interior to obtain a liquid or gaseous medium from the isolated interior via the functional opening (7); and a second channel extending in the catheter body being provided with an inlet and an outlet at opposite ends, said inlet and said outlet being both arranged in the catheter body outside the isolated interior defined by the balloon (4), It is characterized in that Two annular protrusions surrounding the functional opening (7) are also arranged on the catheter body and between the balloons (4), so that the functional opening (7) is located between and adjacent to the annular protrusions, wherein the annular protrusions are designed so that when negative pressure is generated, the annular protrusions allow a distance to be provided between the mucosal tissue of the hollow organ of the mammal and the functional opening (7), and the mucosal tissue is located between the inflated balloons (4).

7. The catheter (100) according to claim 6, wherein: The functional opening (7) is further covered by a mesh or shell (16), which is permeable to liquid and / or gaseous media.

8. The catheter (100) according to claim 6, wherein: The catheter body of the catheter (100) is also provided with a mesh or shell (16) which is permeable to liquid and / or gaseous media, wherein the mesh or shell (16) at least partially surrounds the catheter body portion defined by the balloon (4) so ​​as to cover the functional opening (7).

9. The catheter (100) according to claim 8, wherein: The mesh or shell (16) is attached to the balloon (4) or surrounds the balloon such that the mesh or shell (16) becomes taut when the balloon (4) is inflated.

10. The catheter (100) according to claim 8, wherein: The mesh or shell (16) surrounds the balloon (4) such that the mesh or shell (16) becomes taut when the balloon (4) is inflated.

11. The catheter (100) according to claim 8, wherein: The net or housing (16) is also fixed to the annular protrusion.

12. A system for isolating the interior of a hollow organ of a mammal, the system comprising: - A catheter (100) according to any one of claims 1 to 11; as well as - a functional device connected to the functional channel (3) to allow the generation of a negative pressure in the isolated interior in order to extract a liquid or gaseous medium from the isolated interior or to supply a liquid or gaseous medium into the isolated interior.

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