RU-2861709-C2 - COLLAGEN OBTURATOR DELIVERY SYSTEM

Abstract

FIELD: medical technology. SUBSTANCE: invention relates to medical technology, namely to a collagen obturator delivery system. The collagen obturator delivery system comprises an introducer in the form of a hollow tube 23 cm long and 8 Fr in diameter made of blue-coloured polyurethane plastic, a polyurethane bougie 28 cm long and 7 Fr in diameter, an inner hollow polyurethane tube 29 cm long and 4 Fr in diameter, and a 29.5 cm long and 3 Fr diameter push-out stylet. The proximal part of the push-out stylet has a cap with an internal screw thread. The inner hollow tube has a screw thread in the proximal part. The distal part of the inner hollow tube is marked with a radiopaque marker, and inside it there is a collagen polymer compressed in the form of 4 seals, designed to expand from 0.03 ml to 0.73 ml under the influence of the external environment. The introducer is designed to allow a bougie to be inserted into it. The bougie is designed to allow an inner hollow tube to be inserted into it. The inner hollow tube is designed to allow a pushing stylet to pass through it. EFFECT: reduction of the risk of bleeding and/or bile leakage into the abdominal cavity during early removal of cholangiosurgical drainage or in the case of slow formation of a stable sealed channel from connective tissue that separates the bile ducts and liver parenchyma from the abdominal cavity. 1 cl, 1 dwg

Inventors

• CHECHENIN GRIGORIJ MIKHAJLOVICH
• Marshall Vlada Konstantinovna
• Andreev Yurij Germanovich

Dates

Publication Date

20260508

Application Date

20240820

Claims (1)

1. A collagen obturator delivery system comprising an introducer made in the form of a hollow tube 23 cm long and 8 Fr in diameter made of polyurethane plastic painted blue, a polyurethane bougie 28 cm long and 7 Fr in diameter, an inner hollow tube made of polyurethane 29 cm long and 4 Fr in diameter and an ejector stylet 29.5 cm long and 3 Fr in diameter, wherein the proximal part of the ejector stylet has a cover with an internal screw thread, the inner hollow tube is made with a screw thread in the proximal part, the distal part of the inner hollow tube is marked with a radiopaque mark, and inside it there is a collagen polymer pressed in the form of 4 seals, made with the ability to increase from 0.03 ml to 0.73 ml under the influence of the external environment, the introducer is made with the ability to insert a bougie into it, the bougie is made with the ability to insert the inner hollow tube into it, and The internal hollow tube is designed to allow the ejection stylet to pass through it.

Description

The invention relates to the field of medical technology, namely to the field of devices for interventional radiology and minimally invasive surgery. The number of patients with mechanical jaundice of various etiologies is growing every year. Regardless of the nature of the mechanical blockage in the bile ducts, patients require emergency surgical intervention. Often, mechanical jaundice syndrome is accompanied by the development of cholangitis and liver failure, which increases the risk of postoperative complications [1]. A safer treatment method for patients is minimally invasive interventional surgery, specifically percutaneous transhepatic interventions. Unlike retrograde endoscopic bile duct decompression techniques (EPDTs, stenting with a plastic stent), antegrade interventions have the advantage of eliminating the need to dissect the major duodenal papilla and can be used at various levels of the block [2]. However, it should be noted that antegrade minimally invasive surgical interventions also carry a risk of postoperative complications. During the first stage of treatment—creating a percutaneous transhepatic cholangiostomy—drainage may become dislocated, leading to blood and/or bile leakage into the abdominal cavity. Infected bile in the abdominal cavity leads to biliary peritonitis, with subsequent complications, including death. The second stage of treatment for patients with obstructive jaundice involves antegrade stenting of the stenosis. Since the self-expanding stent does not immediately reduce intraductal pressure, bile will flow along the pressure gradient through the unformed cholangiostomy channel into the abdominal cavity. It should also be taken into account that the presence of a cholangiostomy tube significantly reduces the quality of life of patients [3]. A number of studies have shown that the average time it takes to form a mature cholangiostomy channel is 20 days [4]. However, in some cases, a longer period of time is required to establish a mature tract connecting the liver to the anterior abdominal wall. This is due to a number of factors and, in most cases, is due to pathological changes in the liver parenchyma, such as cirrhosis, post-chemotherapy conditions, total metastatic liver damage, or the systemic effects of liver diseases complicated by the development of ascites and hypoalbuminemia. In such pathological conditions, the liver's reparative capacity, which is essential for the formation of cicatricial changes and the construction of a sealed puncture channel, is reduced. Of the existing methods for resolving postoperative complications, two options exist: repeated ultrasound-guided bile duct drainage or laparoscopic interventions. Given the severity of the patient's condition, even laparoscopic procedures carry a high risk of postoperative complications, including death [1]. The objective of the invention is to improve the treatment results for patients with mechanical jaundice syndrome, reduce the risk of developing postoperative complications and prevent the need for repeated minimally invasive or laparoscopic interventions. The stated problem is solved by developing an improved device that allows for precise obturation of the cholangiostomy canal while stopping external bile drainage, thereby simultaneously stopping bleeding and bile leakage, sealing the bile ducts, and accelerating the healing process. The technical result of the proposed method is a reduction in the risk of bleeding and/or bile leakage into the abdominal cavity during early removal of a cholangiostomy drain or in the case of the slow formation of a stable, sealed connective tissue channel separating the bile ducts and liver parenchyma from the abdominal cavity. Figure 1 shows a schematic representation of the collagen obturator delivery system. This technical result is achieved through the device's design: 1. Application of the external part - introducer, painted blue, made of polyurethane with a diameter of 8 Fr, 23 cm long (1, Fig. 1). 2. The internal part (2, Fig. 1) is a bougie, painted white, made of polyurethane, with a diameter of 7 Fr, the distal end of a conical shape, which pushes apart the tissues without damaging the liver capsule. 3. The internal component of the system is 29 cm long, 4 Fr in diameter, and made of polyurethane. It has a radiopaque marker on the distal end, and the proximal end is threaded. The tube contains a collagen polymer in the form of four compressed plugs, which expand from 0.03 ml to 0.73 ml when exposed to fluid from the surrounding tissue (3, Fig. 1). 4. A plastic ejector element, 29.5 cm long, 3 Fr in diameter, made of polyurethane. The proximal part is equipped with a cover with an internal screw thread (4, Fig. 1). All patients achieved positive results. No intra- or postoperative complications were observed. The novelty of the proposed invention is that similar collagen polymers have previously been used in cardiovascular surgery to stop bleeding from sm