RU2602655C1 - Device for duodenal bleeding arrest - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, surgery, endoscopy, and concerns problem of duodenum bleeding arrest by installing stents. Device for duodenum bleeding arrest contains tubular elongated mesh frame of wire with shape memory. Frame has input end part, made with outer surface for pyloric section of stomach with possibility of fixation in this section, central expanded part with outer surface for duodenal bulb and outlet part with outer surface for descending part of duodenum with possibility of fixation in this section. Diameter of places of programmed narrowings between inlet and central parts exceeds diameter of pylorus and bulbo-duodenal transition respectively.

EFFECT: advantages of device are reliability, stability and easy installation of stent, as well as possibility of reposition of stent at dislocation during installation or afterwards.

3 cl, 3 dwg

Description

The invention relates to medicine, surgery, endoscopy and relates to the problem of stopping bleeding from the duodenum using installed stents.

Stenting is widely known to stop bleeding in the hollow organs, as well as to ensure the lumen of the hollow organs in cases of cicatricial, tumor stenosis.

The main problems of this area of surgery are - ensuring the anatomical compatibility of the device with the surface of the hollow organ, eliminating the possibility of device migration and development of complications, such as ulceration of the organ wall, bleeding, perforation, ensuring the convenience of stent placement in this particular organ.

There are many modifications of stents for the gastrointestinal tract to ensure patency of the gastrointestinal tract (gastrointestinal endoprosthesis), the installation of which one of the types of complications is the development of bleeding (Klimov A.E. et al. Endoprosthetics of the upper digestive tract, http: / /stents.ru/endoprosthesis_of_the_upper_gastrointestinal_tract.php). At the same time, the principles of the development of devices both for stopping bleeding in the lumen of the gastrointestinal tract, and for ensuring the patency of the gastrointestinal tract, seem similar in terms of the form of the products, as well as the material of their implementation, the possibility of easy insertion into the gastrointestinal tract, and retention in the desired location position, in the possibility of self-correction.

So, violations of patency and integrity (with bleeding) of the upper gastrointestinal wall are urgent conditions that require correction as soon as possible with minimal invasiveness for the patient.

The installation of self-expanding stents is a safe, reliable and cost-effective method in comparison with other currently existing methods. Radical surgical treatment for malignant stenosis of the gastrointestinal tract is impossible due to the unresectability of the tumor or the patient’s serious condition. Palliative surgical treatment in this case is associated with a high frequency of complications, mortality, the duration of inpatient treatment and its higher cost, not leading to an improvement in the quality of life, but, on the contrary, enhancing psychological trauma.

The use of other endoscopic methods for recanalization of the lumen - electro- and laser coagulation, bougienage, balloon dilatation - requires long-term treatment with repetition of sessions, while their effectiveness is short-lived. The installation of plastic endoprostheses also has significant disadvantages in comparison with self-expanding stents - a high percentage of complications, including fatal ones, lengthy hospitalization, high cost of treatment, the complexity of installation and removal. When using coated self-expanding endoprostheses, for example, to close esophageal and respiratory fistulas and esophageal perforations, a positive effect is observed in 78-100% of cases. The treatment of these patients takes place without traditional surgical intervention, which not only reduces the percentage of complications and mortality in this group of extremely severe patients, but also allows to reduce the duration of inpatient treatment and restore patients' natural nutrition as soon as possible.

Classification of self-expanding stents for the upper gastrointestinal tract

According to the material:

- metal - stainless steel, nitinol (titanium nickelide), Elgiloy (an alloy based on nickel, cobalt and chromium;

- plastic - polyester;

- absorbable (biodegradable) - polylactate, polydioxanone.

By coating:

- uncovered;

- coated with silicone, polyurethane, polytetrafluoroethylene.

According to the location of the lesion:

- esophageal

- pyloroduodenal.

For the purposes of the present invention, pyloroduodenal stents are of interest.

There are two types of pyloroduodenal stents that differ in delivery method: delivered through the endoscope channel (Through The Scope - TTS) and installed under radiological control (non-TTS):

- HANAROSTENT (M.I. TechCo., Ltd, Korea) is a self-expanding nitinol tubular prosthesis. Both ends of the stent are funnel-shaped for reliable fixation in the duodenum. HANAROSTENT is available in three versions: coated, partially coated (has an uncoated portion at the proximal end to minimize the risk of migration) and uncoated.

The main disadvantage of these stents when using them to stop duodenal bleeding is insufficient diameter and, as a result, frequent dislocation.

- The Dual Expandable Nitinol Stent (S&G Biotech, Korea) consists of two stents: external partially coated and internal uncoated. The inner stent is woven from nitinol yarn and has a tubular configuration. The outer stent consists of 3 parts: proximal and distal uncovered nitinol and nylon. The proximal and distal parts are woven from a single nitinol thread with a diamond-shaped cell.

However, such a stent is almost impossible to remove without trauma to the surrounding tissue. In this connection, when using it, the risk of developing recurrence of bleeding is high.

- WALLSTENT ENTERAL STENT (Boston Scientific Corp., USA) - a braided steel tubular stent with sharp ends. This is a drawback, since stents are significantly rigid and can cause damage to the mucous membrane and lead to the formation of proximal and distal strictures.

- WALLFLEX (Boston Scientific Corp., USA) - nitinol stent. The use of nitinol and modifications in the mesh structure made the stent more flexible than the previous model. Unlike WALLSTENT, it gradually expands to the proximal end, which reduces the risk of distal migration, but does not interfere with proximal migration, and under certain conditions (active peristalsis, for example) even promotes proximal migration. In addition, the stent is not available in coated form, therefore, its use for stopping bleeding is significantly limited, it quickly grows into the surrounding tissue, which makes it difficult to remove the stent and the risk of bleeding recurrence.

A device for the dilatation of hollow organs (RU 2123809 C1, 12/27/1998, G. Dambaev, etc.), which contains a conveyor in the form of a flexible tube and placed in the tube with a gap in diameter, a flexible rod with a tube end cap fixed to its end , a dilator formed by the regular interweaving of two groups of bifillarily wound cylindrical wire spirals of the same diameter and length, located between the tube and the rod in a section adjacent to the working end of the conveyor. The radius of the flexible rod over the entire dilator is reduced from the main size by an amount not less than twice the transverse size of the spiral wire. A superelastic titanium nickelide with a shape memory effect is selected as the dilatator material. The result is an increase in the adaptive ability of the dilator to the transverse dimensions of the hollow organ, and simplification of the delivery of the dilator.

This device is uncovered and, therefore, retains all the disadvantages of uncovered stents when trying to use them to stop bleeding from hollow organs.

Self-expanding metal stents for treating acute bleeding from varicose veins of the esophagus are known (BODLAGE J. et al. Use of self-expanding metal stents for treating acute bleeding from varicose veins of the esophagus, 10/20/2008, http://www.medlinks.ru/ article.php? sid = 33974). To avoid most complications, a special stent was developed to stop bleeding from varicose veins of the esophagus, in which the benefits outweighed the risk. Modified stents (Denis stent, Ella-Denis stent) were tested for functionality and safety in animal studies (unpublished data) before they were used in humans. Denis's stent (Danisha) is made in a form that corresponds to the anatomical configuration of the esophagus and varicose veins, especially its distal part - 4-6 cm. The length of the stent is chosen to be 135 mm, which, on average, ensures that its proximal end is peripheral to an aortic arch in order to avoid excessive pressure. An insertion device makes radiographic control unnecessary. Correct insertion is carried out by the inflated balloon at the distal end of the insertion device, which ensures proper positioning when the balloon is pulled into the cardia before the stent is expanded. A wire loop at each end and a special shape allow stretching and narrowing of the stent to remove it.

The shape of such a stent does not prevent dislocation during relatively long standing and the nature of the delivery device allows it to be used only to stop esophageal bleeding.

Known pyloroduodenal stent ENTERELLA for palliative treatment of malignant structures of the pyloroduodenal zone (http://stents.ru/doc/pyloroduodenal.pdf), providing their lumen, which is a mesh cylindrical structure in the form of a self-expanding nitinol pyloroduodenal stent placed in the delivery system. Installation is carried out under fluoroscopic and / or endoscopic control. There are modifications of the stent with a polyurethane coating and without coating, of different diameters and lengths. The stent has atraumatic ends to reduce the likelihood of trauma to the gastrointestinal wall, has good flexibility to allow easy passage through complex anatomical bends. For better visualization of the stent, radiopaque markers are located on its body and at both ends. The loop at the proximal end of the stent makes it possible to reposition it for 5 days after installation. There is a stent reposition system - the ability to pull it back into the delivery system during implantation.

The main disadvantage of this stent is the lack of an anti-migration (positioning) mechanism.

Thus, the known devices have a number of disadvantages when trying to use them to stop and prevent recurrence of bleeding from the duodenal bulb. Disadvantages include a lack of atraumatic coverage, weak anti-migration mechanisms. The described stents show themselves quite well when straightening various types of strictures of the gastrointestinal tract, mainly malignant. The presence of stricture in this case itself serves as an anti-migration mechanism. Moreover, coated types of stents are able to stop bleeding from decaying tumors of hollow organs, but only in cases where the anatomy of the organ is significantly changed, it is rigid and its lumen is significantly narrowed. The cylindrical shape of the stents provides for their use only in an organ close in shape to a regular tube, and, therefore, cannot provide compression of parietal bleeding vessels in the spherical bulb of the duodenum, especially if the organ is not anatomically modified or little changed.

A known apparatus for stopping bleeding from a duodenal ulcer (WO 8900407 A1, 01/26/1989) by applying increased physical pressure inside the duodenal. The device includes an inflatable balloon, means for installing the balloon at the distal end of the endoscope, while the balloon can be delivered in a deflated state into the duodenum through an endoscope. Bleeding is stopped by the tamponade method with a pumped balloon. After removing the endoscope, the continuity of the gastrointestinal lumen is maintained through the opening of the sleeve on which the balloon is inflated.

A device such as balloon tamponade, designed to treat bleeding from the upper digestive tract (esophagus, stomach, duodenum) US 5308326 A, 05/03/1994. This design is the closest analogue of the developed device.

The device comprises a tube having a proximal and distal open ends and at least one or two inflatable balloons mounted on the tube. Depending on the use in the required gastrointestinal tract, device cylinders are positioned and positioned in such a way that they are inflated elements, respectively, for the esophagus and the upper part of the stomach, or for the pyloric part of the stomach and duodenum, or only the duodenum.

This device can be used for the delivery and use of removable coatings for the treatment of bleeding, in particular, such as an expandable mesh, the use of chemicals in the form of coating gels that help stop the bleeding. The mesh can be installed on the esophagus balloon by laying on the inflated element in a deflated state, and then with the possibility of expanding the mesh material to the full size of the inflated element of the corresponding location. The mesh can be impregnated with hemostatic preparations in the form of a gel.

The known device also carries a number of disadvantages:

1) The carrier tube is rigid, does not take the anatomical shape of the intestine, its installation with strictures is problematic.

2) One and even two cylinders are not able to provide a stable anti-migration effect, the device will certainly be deployed in the lumen of the stomach. For fixation in the bulb of the duodenum, a third fixing element (balloon) is required in the post-bulbar section, which will significantly complicate the already complicated design.

3) The duodenal installation of the device is extremely difficult technically, it is actually performed blindly, which makes accurate positioning difficult. Repositioning the device after removing the endoscope is not possible.

4) When performing a control endoscopic examination to assess the effectiveness of hemostasis during the examination of the postbulbar parts of the duodenum, it is possible to develop a device dislocation due to pinching of the endoscope in the device’s tube, because the diameter of the tube is very close to the diameter of the device. Under these conditions, no cylinder can hold the tube in place at the time the endoscope is removed.

Solved in the present invention, the task is to develop a device devoid of the disadvantages of known analogues.

The technical results of the developed device are:

1) the reliability and stability of the stent installation, due to:

- congruence of the stent to the lumen of the duodenal bulb,

- an anatomical anti-migration mechanism, which includes a spherically expanded part of the stent and funnel-shaped edges, one of which is fixed behind the pylorus in the pyloric part of the stomach, the other in the retrobulbar, much narrower part of the duodenum;

2) ease of installation.

Installation is controlled by vision. The stent independently takes the form programmed for nitinol and, thus, occupies the most effective position to stop bleeding. For added installation convenience, the stent is equipped with a bright, positioning stent mark (marker) in the place of the programmed pyloric constriction (“waist”), and the outer braid of the delivery device is transparent. Installation is also possible under radiological control, which is facilitated by radiopaque marks at the edges of the stent and in the waist area. It is advisable to carry out the radiopaque marks in golden colors for additional contrast when visually monitoring the installation and subsequent monitoring of the stent position.

3) the possibility of reposition of the stent in case of dislocation that occurred during installation or subsequent dislocation due to the elasticity of the stent and the positioning loops “lasso” installed along the edges of the stent.

In addition, the developed device design allows for control studies and manipulations in the post-bulbar department, immediately after the installation and deployment of the stent, because its diameter significantly exceeds the diameter of the endoscope.

The developed stent can be installed:

- with severe cicatricial deformity of the duodenal bulb, which excludes holding an endoscope beyond the stricture area. In this case, the stent, in addition to stopping bleeding, also restores the lumen of the intestine, providing recanalization,

- with cicatricial stricture, when it is impossible to ensure a tight fit of the walls of the stent to the surface of the duodenal bulb, persistent hemostasis is achieved due to the effect of tamponade of the lumen of the duodenal bulb between its wall and the wall of the stent.

At the same time, the parts of the stent that are narrowest in diameter exceed the diameter of the pylorus and the bulboduodenal junction and contribute to the formation of a sealed cavity in which humoral coagulation factors quickly realize their activity.

The developed device for stopping bleeding from the duodenum is presented in the form of a tubular elongated mesh frame made of wire with shape memory. The frame has an input end part made with an external surface under the pyloric stomach section with the possibility of fixation in this section, a central expanded part with an external surface under the duodenal bulb and an output part (distal) with an external surface under the descending part of the duodenum with the possibility of fixation in this department. Moreover, the shape of the cells and the section of the walls of the central part are made in such a way that they compress the vessels of the bulb of the duodenum, and the shape of the cells and the section of the walls of the cells of the output end part compress the vessels of the descending part of the duodenum.

The end parts in the expanded state (working) have the same size. Moreover, the central part has a larger size (diameter) than the end ones. The end parts in the expanded state create a seal when bleeding from the bulb of the duodenum, and the central part, in addition to directly squeezing the bleeding zone, provides an anti-migration effect, and also reduces the volume of the hematoma formed, due to a decrease in the free space in the bulb of the duodenum.

In addition, the diameter of the waist of the stent (the place of the programmed narrowing between the inlet and the central and central and output parts) should exceed the diameter of the pylorus and bulboduodenal junction, respectively, which contributes to the formation of a sealed cavity in which humoral coagulation factors quickly realize their activity.

Another important feature of the developed device are labels:

- bright in the area of the "waist" of the stent, which contributes to visualization of control over the positioning of the stent with the option of conducting it through the channel of the endoscope;

- radiopaque along the edges of the stent and in the waist area. A stent with this kind of label is used for the option of introducing the installation of the device under radiological control.

The design of the device is illustrated in the drawings.

In FIG. 1 shows a delivery device comprising a stent:

1 - handle delivery device;

2 - stent;

3 - external braid;

4 - inner braid;

5 - clamp external braid;

6 - soft protective distal cap;

13 - positioning stent label.

FIG. 2. A stent in the open (working) state in the output section of the stomach and duodenum:

7 - pyloric pulp;

8 - radiopaque marks in the proximal part of the stent;

9 - radiopaque marks in the distal part of the stent;

10 - the middle part of the stent;

11 - repositional loops "lasso".

FIG. 3. Open stent:

8 - radiopaque marks in the proximal part of the stent;

9 - radiopaque marks in the distal part of the stent;

10 - the middle part of the stent;

11 - repositional loops "lasso";

12 - thallium of the stent.

The device is used as follows.

The stent is installed in such a way that its funnel-shaped edges abut against the walls of the tubular organ, while the proximal “waist” of the stent is located in the pyloric canal (Fig. 2, position 7), and the proximal funnel-shaped edge in the prepiloric section of the stomach. The distal “waist”, as well as the distal funnel-shaped edge, is in the postbulbar part of the duodenum. The widest middle part of the stent (Fig. 2, 3, position 10) is located in the duodenal bulb. Thus, the source of bleeding is either pressed, or (with significant scar deformity of the bulb) is localized in a closed cavity of small volume between the wall of the intestine and the walls of the stent. In this case, blood from this small cavity is not evacuated, it accumulates, which leads to tamponade of a bleeding vessel, activation of hemostasis factors and, ultimately, stopping bleeding.

The success of the stent positioning and “non-displaceability” is ensured by the anatomically determined anti-migration mechanism, which includes a spherically expanded middle part of the stent located in the duodenal bulb and funnel-shaped edges, one of which is fixed behind the pylorus in the prepyloric part of the stomach, and the other in the retrobulbar, much more narrow part of the duodenum.

A separate advantage of the proposed method is the possibility of its use by the "blind" method, in conditions of poor visibility with ongoing profuse bleeding. The method is technically simple and can be successfully applied by ordinary specialists with little experience.

Application of the method can significantly reduce the duration of endoscopic intervention to stop bleeding and, thus, significantly reduce the total amount of blood loss.

Provided using the claimed method, an express stop of bleeding from the duodenal bulb allows the patient to stabilize until complete recovery or to fully prepare him for a possible subsequent planned surgical intervention.

Stent placement is also possible as a preventive measure in case of high risk of bleeding recurrence and difficult application of standard methods of prophylaxis of bleeding recurrence - in case of large callous ulcers, ulcers against the background of cicatricial deformity of the organ, severe general condition of the patient.

For clinical signs of bleeding, a prospective bleeding site is preliminarily examined with a flexible endoscope with a wide instrument channel (the diameter required for the delivery device must be at least 3.4 mm). On examination, they try to determine the localization of the source of ongoing bleeding (a pulsating stream or the flow of light arterial blood) or the localization of a peptic ulcer with a high risk of recurrence of bleeding.

If it is impossible to conduct a standard endoscopic guide to stop bleeding or its inefficiency, a decision is made to install a stent in the area of bleeding or ulcerative defect.

A flexible conductor string (for example, MET-35-480 string from Willson-Cook, Ireland) is passed through the instrumental channel of a flexible endoscope beyond the bleeding area. Through the inner braid (Fig. 1, position 4), a delivery device is carried out over the bleeding area along the string to the conductor.

The delivery device can be performed, for example, in two versions:

1) Length 110 cm, diameter 7-8 mm, for carrying out under x-ray control or visual control when carried out next to the endoscope.

2) 180 cm long, 3.2-3.8 mm in diameter, for passing through the working channel of the endoscope.

The safe conduct of the device is facilitated by a soft protective distal cap (Fig. 1, position 6). The outer braid (Fig. 1, position 3) of the delivery device is unlocked using the outer braid lock (Fig. 1, position 5) located on the handle (Fig. 1, position 1) and is displaced in the proximal direction. In this case, the stent (Fig. 1, position 2) is gradually straightened and fixed in the lumen of the intestine, capturing and squeezing the area of the bleeding vessel. Accurate positioning of the stent is facilitated by a bright mark in the projection of the proximal "waist" (Fig. 1, position 13), which should remain in front of the pyloric canal (Fig. 2, position 7) when the stent is opened.

With the option of installing the stent under X-ray control, accurate positioning is facilitated by radiopaque golden marks at the edges (Fig. 2, 3, positions 8 and 9) of the stent and in the area of both “waist” of the stent (Fig. 2, 3, positions 8 and 9).

Considering that the diameter of the stent lumen in the expanded state is not less than 22 mm, immediately after installation it is possible to conduct an endoscope in the distal direction beyond the stent area. This allows you to examine the distal and proximal edges of the stent, to assess the degree of disclosure and the tightness of the edges of the stent to the walls of the hollow organ and to prevent blood leakage from under the edges of the stent.

If necessary, a partial clarifying reposition of the stent is possible using proximal and distal repositional loops (“lasso”) (Fig. 2, 3, position 11).

With the correct installation of the stent, blood flow into the lumen of the gastrointestinal tract stops. After washing the blood and clots from the lumen of the duodenum, a second examination is performed and, in the absence of blood leakage, the study is terminated.

Control studies with examination of the stent area are carried out as planned - once a day for three days from the moment of bleeding or urgently - at the clinic of bleeding recurrence.

The stent remains in the lumen of the organ for a period of up to 4 weeks - until the patient is completely stabilized and the alleged duodenal defect is scarred. Next, the stent is removed using an endoscope by traction for the proximal lasso loop, which leads to the collapse of the stent and a decrease in its diameter for more delicate extraction. The area previously covered by the stent is inspected again.

Claims (3)

1. Device for stopping bleeding from the duodenum, containing a tubular elongated mesh frame made of wire with shape memory,
characterized in that
the frame has an input end portion made with an outer surface under the pyloric stomach, with the possibility of fixation in this department,
the central expanded part with the outer surface under the duodenal bulb
and the output part with the outer surface under the descending part of the duodenum with the possibility of fixation in this section,
moreover, the diameter of the places of the programmed constrictions between the input and central and central and output parts exceeds the diameter of the pylorus and bulb-duodenal junction, respectively. 2. The device according to p. 1, characterized in that in the place of the programmed pyloric constriction is a positioning stent mark. 3. The device according to p. 1, characterized in that in the places of the programmed restrictions and at the edges of the input and output parts are radiopaque marks.

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