RU195383U1 - BENCH FOR ENDOSCOPIC TREATMENT Pseudocyst Pancreas - Google Patents

Abstract

The utility model relates to the field of medicine, medical equipment, namely to drainage devices that can be used in surgery for endoscopic treatment of pancreatic pseudocysts. The stent for endoscopic treatment of the pseudocyst of the pancreas is made in the form of a tubular element having a nitinol mesh structure, a proximal and distal sections and a longitudinal cylindrical section located between them, equipped with a valve configured to prevent the gastric contents from being thrown into the pseudocyst cavity, providing an outflow of the contents of the cyst into the process of sanitation of the cyst through the drainage tube, for which the valve is equipped with a corresponding hole in the central part . The stent is made self-expanding after installation. Its longitudinal cylindrical section is provided with a polyurethane film coating over the entire surface. The technical result is to reduce the risk of reinfection. 7 cp crystals, 5 ill., 1 approx.

Description

The technical field to which the utility model relates.

The utility model relates to the field of medicine, medical equipment, namely to drainage devices that can be used in surgery for endoscopic treatment of pancreatic pseudocyst (PC pancreas).

State of the art

In the structure of acute surgical diseases of the abdominal organs, acute pancreatitis (OP) takes third place, ranging from 4.5 to 10%. In the Russian Federation, the total number of patients with OP was 38 per 100,000 people. It should be noted the increase in mortality from this disease from 83,000 deaths in 1990 to 132700 in 2015 [8].

Late complications of OP include pseudocysts (PCs), the incidence of which is from 0.1 to 1 case per 100,000 adults per year. With large PC sizes, surgical treatment is most appropriate. However, the problem of choosing the optimal time, volume and type of surgical intervention is still relevant. The highest priority for determining surgical tactics is the period of existence, localization, size of the cavity, the presence of its relationship with the duct system of the pancreas, as well as the presence of complications and concomitant lesions of nearby organs.

To date, multiple resection surgical interventions from laparotomy or laparoscopic approaches have been developed. However, all of them are accompanied by a significant number of complications (from 15 to 29%), high postoperative mortality (from 12 to 17%) and a fairly long postoperative period (from 12 to 28 days). Currently, the availability of modern equipment allows for similar surgical interventions using flexible endoscopy.

In particular, technical solutions are known from the prior art regarding the treatment of pancreatic ulcer drainage by draining localized fluid accumulations in the pancreas under the control of endoscopic ultrasonography, the formation of cystogastrostomy or cystoduodenostomy (EUS-CGS, EUS-CDS) using plastic stents or metal self-opening as a drainage device stents, or partially coated with metal self-expanding stents, and puncture emptying of pseudocysts by vacuum aspiration of the contents. (https://rusendo.ru/ru/archive/theses-ru/79-2016-god/ostryj-i-khronicheskij-pankreatit/856-endoskopicheskie-sposoby-vnutrennego-drenirovaniya-psevdokist-podzheludochnoj-zhelezy.html).

However, when using these stents in the drainage process, gastric juice enters the lumen of the PC, which leads to infection and suppuration of its contents. The inventive device allows the use of an etiopathogenetic method of treating PC and avoiding infection of the PC with gastric juice due to the presence of a valve in the design of a self-expanding metal stent with a partial polymer coating.

The technical problem solved by the claimed utility model is the development of a device that allows drainage of pancreatic ulcer with minimally invasive, less traumatic intervention, while reducing the risk of gastric contents entering the lumen of the pancreas, as well as reducing the risk of stent displacement in the course of PC drainage.

Utility Model Disclosure

The technical result is to reduce the risk of reinfection (caused by the entry of gastric contents into the PC cavity) in the treatment of pancreatic PC due to the formation of a barrier that prevents the gastric contents from being thrown into the PC lumen, while ensuring the outflow of the cyst contents during cyst sanitation through the drainage tube, which allows in a minimum time to clean and obliterate the pseudocyst cavity, in a shorter time to achieve the therapeutic effect of PC pancreas.

The technical result is achieved through the use of a stent for endoscopic treatment of the pseudocyst of the pancreas, made in the form of a tubular element having a nitinol mesh structure, a proximal and distal sections, and a longitudinal cylindrical section located between them, equipped with a valve configured to prevent the gastric contents from being thrown into the cavity pseudocysts ensuring the outflow of the contents of the cyst during the rehabilitation of the cyst through the drainage tube, for which The swarm valve is provided with a corresponding hole in the central part, the stent is self-expanding after installation, and the longitudinal cylindrical section is provided with a polyurethane film coating over the entire surface.

A polyurethane film coating is provided on the inside of the at least cylindrical portion of the stent.

The stent in one embodiment is made with the following dimensions: the length of the cylindrical section is 40 mm with the possibility of overlapping the section between the walls of the stomach and the PC, the diameter of the cylindrical section is 14 mm, the length of the proximal and distal sections is 5 mm, the maximum diameter of the proximal and distal sections when opening stent - 26 mm.

The valve, as a rule, consists of three identical petals, made axially movable towards the stomach, overlapping the tent opening (when projected onto the transverse plane, they fill the cross-sectional area of the cylindrical section of the stent in the “open” state) with the formation of holes with a diameter along the stent axis 0.2-0.3 mm to allow a drainage tube to be inserted into the cyst cavity. Moreover, the valve petals can be made of inelastic polyurethane film with a thickness of 0.2-0.5 mm, which are fixed in a rigid frame. The valve petals may be convex. The valve petal frame can be made of nitinol or polymer thread with a diameter of up to 2 mm.

Distinctive features of the drainage device used in the endoscopic treatment of pancreatic PC non-cancerous genesis are:

1. The use in the design of a self-expanding stent valve that prevents the throwing of gastric contents into the lumen of the pseudo cyst, which leads to a reduction in complications such as infection and suppuration of its contents.

2. The design of the valve includes three petals made of polyurethane and located in the distal part of the stent with the formation of an axial hole that allows you to install cystasal drainage through it, which allows you to sanitize the pseudocyst cavity.

3. The use of a self-expanding stent with a coating and its proximal and distal opening for stenting ensures reliable fixation of the stent at the installation site, which reduces the risk of stent displacement (provides anti-migration effect) due to the presence of extensions on the proximal and distal sections of the stent, and prevents stent ingrowth into adjacent tissues. In addition, the proximal opening of the stent creates the possibility of endoscopic visualization of all stages of the opening of the stent and does not require additional x-ray guidance.

Brief Description of the Drawings

The utility model is illustrated by drawings, where in FIG. 1 is a longitudinal section through a stent with a valve; FIG. 2 - presents a General view of the stent with the valve; in FIG. 3 - valve, front view, in FIG. 4 is a valve, a general view from the side of the proximal end of the stent, in FIG. 5 - valve, general view from the distal end of the stent.

The positions in the figures indicate: 1 - polymer coating, 2 - valve, 3 - stent frame, 4 - hole for cystonasal drainage, 5 - base of the stent, 6 - valve petal.

Utility Model Implementation

The claimed solution is intended for endoscopic treatment of pseudocyst of the pancreas. This stent can be used for any localization of the pseudocyst of the pancreas, and for non-homogeneous contents of the cyst, it allows for program sanitation or cystasal stenting.

The stent is made self-expanding (self-expanding) and is a tubular element with a through gap in the form of a single lattice frame or weave, for example, woven from a metal wire - a nitinol thread, having a proximal and distal sections (segments) and a longitudinal cylindrical section located between them. The interface between the proximal, distal end and the cylindrical section is the plane beyond which there is an increase in the diameter of the proximal and distal ends of the stent. The stent in its original form is in a compressed state with a diameter of 0.5 cm (all sections - proximal, distal, cylindrical). After the stent is opened at the installation site, the diameters of all its sections increase. In the initial state, the stent can be compressed in the transverse direction and / or reduced in the radial direction by stretching in the longitudinal direction. To ensure the possibility of its transition to the expanded (expanded) state, illustrated in the drawings, it can be made self-opening due to elastic forces or shape memory.

The surface of the longitudinal cylindrical portion of the stent is made with a polymer film coating on the outside or inside to prevent the stent from growing into adjacent tissues, with a coating on the inside being preferred. The coating can be made of a smooth polyurethane film up to 0.2 cm thick.

The stent also has a valve with a diameter of 1.1-1.3 cm, which prevents the gastric contents from being thrown into the lumen of the PC, which consists of three identical petals (valves or flaps) filling the cross section of the stent with the formation of holes along the stent axis with a diameter of 0.2- 0.3 mm to allow for the holding / placement of a drainage tube (0.2-0.3 mm in diameter) into the cyst cavity through a stent. Each petal of the valve in shape resembles a sector of a circle with petals filling the entire area of the circle in projection onto the cross section of the stent at the location of the valve. The valve petals are made of inelastic polyurethane film with a thickness of up to 0.2, which, when closed, form a central (axial) hole through which cystasal drainage is performed. In an embodiment, a wall with a polymer film coating, this coating can extend to the valve petals. Moreover, during use of the stent, the petals may have a convex shape, as shown in FIG. 4, 5. Each petal can be fixed in a rigid frame, for example, metal (for example, from the nitinol filament from which the stent is made) or polymer, with the frame of each petal attached to the inner surface of the stent. The convex shape of the stent lobes is characterized by a larger surface area, which allows increasing the resistance to the reverse flow of the gastric contents into the lumen of the cyst and during the creation of positive pressure in the cavity of the cyst, for example, in the process of rehabilitation through the drainage tube, unhindered exit of the contents of the cyst. This valve function is provided due to the mobility of the petals, which can be implemented by any means known from the prior art. The valve in the process of use is in a "closed" state, being a barrier to gastric contents, preventing reflux, and "opens" with increasing pressure from the PC.

The valve is installed in the central part of the cylindrical section. During use, a small hydraulic pressure is applied to it from the side of the stomach and significant pressure from the side of the PC in the process of cavity rehabilitation. At the same time, it will be better to open and close under conditions of a difference in pressure acting on a unit area on both sides.

In a preferred embodiment, the stent is characterized by the following dimensional parameters: the length of the stent (tubular element) is 5 cm, the length of the distal / proximal parts is 0.5 cm, the diameter of these parts is 2.6 cm, the diameter of the nitinol thread is 1 mm, the diameter of the longitudinal cylindrical plot - 1.4 cm, the length of the polymer coating is equal to at least the length of the longitudinal cylindrical section.

Endoscopic treatment of the pseudocyst of the pancreas using a stent of the claimed design is as follows.

Under general anesthesia in the patient’s supine position using endoscopic ultrasonography (Endo-ultrasound), the walls of the stomach and duodenum are first examined to identify the bulging of the walls of the hollow organ due to compression from the outside. After that, the final verification of the localization of the PC is performed, the distance between its wall and the hollow organ is determined, the avascular region is detected for the safe installation of the stent. Then, through the intended point, a cystot is inserted into the cavity of the cystic formation. Next, the contents are aspirated, after which, under x-ray control, contrasting is performed to determine its exact dimensions and tightness, and to have a connection with the intraductal pancreatic system. After that, a string is inserted into its lumen through the cystostomy channel, along which a self-expanding metal stent of the claimed design is inserted into the cavity of the pseudocysts. After the stent is inserted into the lumen of the pseudocyst, it opens, while the distal and proximal sections during the opening most firmly fix the stent from the PC and stomach, respectively, preventing its migration during treatment (use). The tools remove and conduct a visual inspection of the stent. Next, cystonasal drainage is performed: under X-ray control, through the lumen of a self-expanding stent, pseudo-cysts are poured into the pockets along the string-conductor with drainage, which allows the introduction of antiseptic solutions into inadequately drained parts of the PC. When an antiseptic solution is introduced into the PC through the drainage, the hydraulic pressure in the PC increases, which ensures the “opening” of the valve petals with the evacuation of the contents of the PC into the lumen of the stomach. With a decrease in hydraulic pressure due to emptying of the PC, the valve petals return to their original position, providing a barrier for the backflow of stomach contents.

Clinical example.

Patient K., 39 years old, was admitted to the admission department of the Sklifosovsky Scientific Research Institute of Surgery, transferring from another medical institution with complaints of girdle pain in the upper abdomen, general weakness, hyperthermia up to 38.0 C. Upon admission, the condition is serious. The skin is pale in color. Pulse 90 beats per minute, blood pressure 130/80 mm RT. Art. The abdomen is swollen, palpation painful in the epigastrium. An ultrasound examination of the abdominal organs revealed homogeneous fluid accumulations in paraduodenal tissue up to 1.2 cm wide, as well as hypoechoic zones up to 1.5 cm wide with single gas inclusions in parapancreatic tissue. The patient was diagnosed with acute pancreatitis, pancreatic necrosis with the formation of infected zones of pancreatogenic destruction in an omental bursa. In the intensive care unit, infusion-detoxification therapy, antisecretory, antibacterial therapy was carried out without a positive effect. At 3 days from the onset of the disease, endoscopic drainage of pancreatogenic destruction zones was performed. When an EUS scan is performed from the antrum of the stomach to the cardiac section of the stomach, the area of pancreatogenic destruction with fluid zones from 0.8 to 1.5 cm thick is visualized along the back wall. The destruction zone is not homogeneous; detritus and sequestration are determined in it. In the cardiac section, an avascular zone was determined during ECM scanning. Using a cystotome, a puncture zone of pancreatogenic destruction was performed. An X-ray examination contrasts an irregularly shaped cavity 5.5 × 3.5 cm in size on the left at the Th11-12 level with uneven fuzzy contours and inhomogeneous due to several fuzzy shadow filling defects. With the further introduction of a contrast agent, irregular-shaped spurs extending from this cavity are crimped, in the form of "fox passages", propagating from the cavity in almost all directions in the projection of the head and tail of the pancreas. With further introduction, paravertebral left, at the level of Th9-10-11, a second large cavity of irregular shape with dimensions of 7.0 × 2.0 cm is contrasted, adjoining almost at right angles to the medial pole and running parallel to the spinal column. In the lumen of the delimited cavity of pancreatogenic destruction, a metal self-expanding stent of the claimed design, shown in FIG. 1. On the stent, there is a flow of hazy hemorrhagic contents with sequesters and purulent flakes with a pronounced ichoric odor. Then, through a central hole in the stent valve, under drainage control, a drain was installed to rehabilitate a cavity with a diameter of 7 fr (2.1 mm), which was removed through the left nasal passage. After stent placement, the cessation of gastric contents into the lumen of the PC was noted. In the postoperative period, the patient underwent daily sanitation of zones of pancreatogenic destruction through cystasal drainage, installed in the stent of the claimed design, with sterile physiological saline in a volume of 100-150 ml, after which 40-50 ml of a solution of 0.01% miramistin was administered through. Also, the patient continued with standard infusion, antisecretory and antibiotic therapy.

During ultrasound examination on the 15th day after drainage, the previously described liquid zones were absent (when using the stent prototype, this effect was achieved only on the 31st day). By this time, the patient completely stopped the pain, the body temperature returned to normal, and a minimal amount (no more than 20 ml) of clear transparent fluid was noted for drainage. The drainage was removed, the patient was discharged for outpatient treatment.

After 60 days from the operation, during the control ultrasound examination of the abdominal organs, there were no areas of pancreatogenic destruction, diffuse changes were noted in the region of the tail and body of the pancreas. The patient underwent esophagogastroduodenoscopy, during which the stent was removed using the farcept.

Thus, the treatment of pseudocysts of the pancreas using the inventive device made it possible to eliminate a surgical complication in a shorter time.

Claims (8)

1. A stent for endoscopic treatment of the pseudocyst of the pancreas, made in the form of a tubular element having a nitinol mesh structure, a proximal and distal sections and a longitudinal cylindrical section located between them, equipped with a valve configured to prevent the gastric contents from being thrown into the pseudocyst cavity, with an outflow the contents of the cyst during the rehabilitation of the cyst through the drainage tube, for which the valve is provided with a corresponding hole in the central parts, while the stent is made self-expanding after installation, and the longitudinal cylindrical section is provided with a polyurethane film coating over the entire surface. 2. The stent according to claim 1, characterized in that the polyurethane film coating is made on the inside of the cylindrical section of the stent. 3. The stent according to claim 1, characterized in that the stent is made with the following dimensions: the length of the cylindrical section is 40 mm with the possibility of overlapping the section between the walls of the stomach and the PC, the diameter of the cylindrical section is 14 mm, the length of the proximal and distal sections is 5 mm, the maximum diameter of the proximal and distal sections during stent opening is 26 mm. 4. The stent according to claim 1, characterized in that the valve consists of three identical petals, made axially movable towards the stomach, filling in the projection of the cross section of the stent with the formation of holes along the axis of the stent with a diameter of 0.2-0.3 mm for providing the possibility of conducting a drainage tube into the cavity of the cyst. 5. The stent according to claim 4, characterized in that the valve petals are made of inelastic polyurethane film with a thickness of 0.2-0.5 mm, which are fixed in a rigid frame. 6. The stent according to claim 4, characterized in that the valve petals are convex in shape. 7. The stent according to claim 5, characterized in that the valve petal frame is made of nitinol thread with a diameter of up to 2 mm. 8. The stent according to claim 5, characterized in that the valve petal frame is made of polymer thread with a diameter of up to 2 mm.

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