Device for introducing a VAC therapy sponge into an area of interest

The device enables efficient sponge placement for vacuum therapy by using a flexible guidewire and self-dissolving thread to compress and expand the sponge, addressing delivery challenges and enhancing treatment efficacy for digestive anastomosis leaks.

WO2026024203A1PCT designated stage Publication Date: 2026-01-29BLINOV EGOR VLADIMIROVICH
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Patent Information

Application Number
PCT/RU2025/050119
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-22
Filing Date
2025-04-28
Publication Date
2026-01-29

AI Technical Summary

Technical Problem

Existing vacuum aspiration systems face challenges in delivering a large polyurethane sponge to the area of interest due to its size and flexibility, requiring additional time, specialized equipment, and increased procedure complexity for treating digestive anastomosis leaks.

Method used

A device comprising a porous polyurethane sponge fixed to a drainage tube with a flexible metal guidewire, a silicone tube, and a self-dissolving thread knot, allowing for compressed sponge insertion and expansion at the defect site.

Benefits of technology

Facilitates rapid and efficient sponge placement without additional time, reduces trauma, and enhances the effectiveness of vacuum therapy by ensuring precise sponge positioning and volume adjustment.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for introducing a VAC therapy sponge into an area of interest comprises a porous polyurethane sponge 1 for aspirating pathological secretion through an organ cavity, and a drainage tube 2, the sponge 1 being fastened to the end of the drainage tube 2. The device is characterized in that it further comprises a flexible metal guide wire 3 mounted in the drainage tube 2, a silicon tube 4 intended to encompass the compressed sponge 1, and a thread 5 compressing the sponge, said thread 5 having a knot 6 thereon which self-releases when the end 7 of the thread is pulled. The invention makes it possible to position a VAC therapy sponge in an area of interest when treating a gastrointestinal anastomotic leak using a vacuum aspirator system, while assuring compression of the entire sponge.
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Description

DEVICE FOR INTRODUCING A VAC-THERAPY SPONGE INTO THE AREA OF INTEREST

[0001] The invention relates to medical equipment. It is designed for inserting a flexible device into the area of ​​interest (where the defect is) during the treatment of digestive anastomosis leaks using a vacuum aspiration system.

[0002] Vacuum aspiration systems (VACs) are used to treat digestive anastomotic leaks. A VAC consists of a nasogastric tube (drainage tube) with a polyurethane sponge attached to the distal end. The sponge's size corresponds to the size of the defect / cavity. One of the main challenges when installing a VAC system is delivering it to the area of ​​interest. This is due to the large size of the sponge itself.

[0003] A sponge insertion device is known, containing a porous bioinert sponge with pore sizes of 400-600 µm for aspirating pathological discharge through an organ cavity and a drainage tube. The sponge is secured to the end of the drainage tube with a thread, the knots of which are formed at the proximal and distal ends of the sponge. The sponge is placed in a container made in the form of a soft, sealed silicone sheath, the open end of which is tightly tied with a thread. The free end of the drainage stub is connected to a vacuum pump with a negative pressure of -200 mmHg. Air is removed, and the sponge, moistened with saline, is frozen in the sealed silicone sheath at -18°C for 25 minutes. The sheath is then removed, and immediately afterward, the sponge is orally inserted into the digestive tube under endoscopic control, positioned on the defect, and connected to a pressure of -125 mmHg. Moreover, every 3 days, 4-9 times in total, the sponge is replaced with a similar one [1].

[0004] However, using the device [1] requires additional time for sponge insertion, as the moistened sponge is frozen in saline. It also requires a freezer with a temperature of -18°C, which limits its intended use and increases the procedure time. Furthermore, inserting a sponge attached to a drainage tube is difficult due to the flexibility of the drainage tube, which bends under external influences and deviates from the insertion path.

[0005] A vacuum system for endoscopic vacuum therapy is known [2]. The vacuum system includes a vacuum pump, a vacuum drainage system, an outer tube assembly which is connected to the vacuum pump of the vacuum system on the low-pressure side and which has a fluid collecting element, an endoscope adapted for insertion into the outer tube assembly, and a probe connected to a pressure regulation unit of the vacuum system for measuring negative pressure. The presented vacuum and endoscopic systems provide the possibility of performing endoscopic vacuum therapy of internal wounds. Sponge drains are suctioned to the intestinal mucosa using a vacuum applied to the sponge and are fixed by negative pressure at the site of placement. The sponge can be adapted to requirements by cutting according to length and volume. The sponge element can be grasped using clamping forceps, polyp clamps or loops and introduced orthogradely during endoscopic guidance.The sponge element has notches on its outer surface for inserting a probe, which can be inserted between the intestinal wall and the sponge element during endoscopic system operation. This additional probe can be used for enteral feeding, gastric emptying, or lavage. A vacuum can be applied to the sponge element while the additional probe is inserted.

[0006] The insertion of a sponge [2] requires the use of endoscopic equipment and a tool for securing the drainage tube; insertion is difficult due to the flexibility (compliance) of the drainage tube, which bends under external influence and deviates from the insertion trajectory.

[0007] Thus, there is a problem of installing a sponge for VAC therapy in the area of ​​interest for performing endoscopic vacuum therapy using a sponge in the treatment of digestive anastomosis leaks.

[0008] The known prior art agents have low efficiency and are limited in their use due to the form of administration.

[0009] A device for introducing a sponge for VAC therapy into an area of ​​interest comprises a porous polyurethane sponge 1 intended for aspiration of pathological discharge through an organ cavity, a drainage tube 2. The sponge 1 is fixed at the end of the drainage tube 2. It comprises a flexible metal conductor 3 installed in the drainage tube 2; a silicone tube 4 intended for enveloping the compressed sponge 1, a thread 5 compressing the sponge, a knot 6 is made on the thread 5 that self-dissolves when pulling on the end 7 of the thread.

[0010] The technical result consists in installing a sponge for VAC therapy in the area of ​​interest during the treatment of digestive anastomosis failure using a vacuum aspiration system, ensuring compression of the sponge throughout its entire volume.

[0011] The technical challenge is to ensure that the VAC therapy sponge is positioned in the area of ​​interest.

[0012] The problem is solved by a device for introducing a sponge for VAC therapy into the area of ​​interest. It contains a porous polyurethane sponge designed to aspirate pathological discharge through the organ cavity and a drainage tube, the sponge being fixed to the end of the drainage tube. It is distinguished by a silicone tube designed to encircle the compressed sponge, a thread that compresses the sponge, the thread having a knot that dissolves when the end of the thread is pulled, and a flexible metal guidewire inserted into the drainage tube.

[0013] No additional time is required for sponge insertion. This eliminates the need for endoscopic sponge vacuum therapy (VAT) in the target area for treating digestive anastomosis leaks. It allows for sponge compression.

[0014] The proposed invention allows a compressed (reduced in volume) sponge to be moved along a guide wire toward the area of ​​interest. Its transverse diameter allows for unrestricted insertion into the organ cavity, allowing for the treatment of digestive anastomosis leaks using a vacuum aspiration system. The use of a thread with a self-dissolving knot allows for the sponge's volume to be reduced and released with a simple movement, increasing the sponge's volume in the defect area, either independently or by combining the thread's compression with that of the silicone tube. Figure 1

[0015] diagram of a device for installing a sponge for VAC therapy in the area of ​​interest, shown in section; Figure 2

[0016] illustrating an uncompressed sponge mounted on a drainage tube with a guidewire; Figure 3

[0017] diagram illustrating a sponge compressed by a thread with a self-dissolving knot; Figure 4

[0018] diagram illustrating a sponge compressed in a silicone tube Description of implementation

[0019] A device for introducing a sponge for VAC therapy into a zone of interest (;;;) comprises a porous polyurethane sponge 1 intended for aspiration of pathological discharge through an organ cavity, a drainage tube 2, the sponge 1 is fixed at the end of the drainage tube 2. It is distinguished in that it comprises a flexible metal conductor 3 installed in the drainage tube 2; a silicone tube 4 intended for enclosing the compressed sponge 1, a thread 5 compressing the sponge, a knot 6 is made on the thread 5 that self-dissolves when pulling on the end 7 of the thread. Example

[0020] A diagram of the device for inserting a VAC therapy sponge into the area of ​​interest is shown, shown in cross-section. The compressed sponge is shown, mounted on a drainage tube with a guidewire. The sponge is shown compressed by a thread with a self-dissolving knot. The sponge is shown compressed in a silicone tube.

[0021] A device for introducing a sponge for VAC therapy into an area of ​​interest () comprises a porous polyurethane sponge 1 intended for aspiration of pathological discharge through an organ cavity, a drainage tube 2 (nasogastric tube), the sponge 1 being fixed at the end of the drainage tube 2. A flexible metal conductor 3 is installed in the drainage tube 2. The sponge 1 is installed in a silicone tube 4 intended to enclose the compressed sponge 1. The sponge 1 is compressed by means of a thread 5 wrapped along the outer surface of the sponge 1 along its length. A knot 6 is made on the thread 5 that self-unravels when the end 7 of the thread 5 is pulled.

[0022] The device is used to treat leaks of digestive anastomoses by connecting it to a vacuum pump.

[0023] The dimensions of sponge 1 correspond to the dimensions of the defect / cavity, or exceed it in size.

[0024] Silicone tube 4 can be made in the form of an Overtube sleeve.

[0025] To install the sponge, determine the size of the defect and shape sponge 1 to match the size and shape of the defect. Fix sponge 1 to the end of drainage tube 2 (nasogastric tube) (). To reduce the transverse size, compress sponge 1 () along the entire perimeter of the outer lateral surface using silicone tube 4 and thread 5. Tie sponge 1 with thread 5, forming a self-dissolving knot 6 that unravels when pulling on end 7 of the thread. Insert silicone tube 4 or Overtube to the defect site using an endoscope. Insert sponge 1 into silicone tube 4, the transverse size of which is smaller than sponge 1, and push it through. Pass flexible metal guidewire 3 in the form of a string through drainage tube 2, guiding guidewire 3 and insert sponge 1 through the organ cavity to the defect area. Place sponge 1 on the defect. Unclench sponge 1 by pulling it out of silicone tube 4 and unraveling thread 5 by pulling on end 7 of thread.Connect drainage tube 2 to a source of negative pressure (vacuum pump), ensuring aspiration of pathological discharge from the defect through the organ cavity to the outside.

[0026] Thus, sponge 1, compressed (reduced in volume) by silicone tube 4 and / or thread 5 with self-dissolving knot 6, moves along the guide wire and is delivered to the area of ​​interest. Its transverse size (diameter) allows for its insertion into the organ cavity without restrictions related to anatomical features, for the treatment of digestive anastomosis leaks using a vacuum aspiration system. Use of silicone tube 4 allows for a decrease in the volume of sponge 1 and its release, increasing the volume (transverse size) of the sponge in the defect area. Use of thread 5 with self-dissolving knot 6 allows for a decrease in the volume of the sponge and its release (by traction on the end of thread 7), increasing the volume (transverse size) of the sponge in the defect area, both independently and by combining compression by the thread with compression in the silicone tube.

[0027] The pore size of polyurethane sponge 1 is preferably between 200 µm and 1000 µm, with a pore size of 400 µm to 600 µm being particularly preferred. The sponge can be tailored to suit specific requirements by cutting it to length and volume.

[0028] The device is used for sponge vacuum therapy to endoscopically place one or more fluid-collecting devices, such as sponge drains, into the intestinal lumen and secure them in place using a vacuum. The sponge drains are suctioned to the intestinal mucosa using a vacuum applied to the sponge and are secured by negative pressure at the insertion site.

[0029] Description of application.

[0030] Patient #1. Diagnosis: rectal cancer cT3N0M0. Primary surgery: anterior rectal resection. Anastomotic leak. VAC system placement: the anastomotic site is identified approximately 2 cm from the anus.

[0031] A defect of 1 / 2 of the anastomosis circumference is identified, with a cavity up to 3.0 cm in diameter and approximately 18-20 cm deep, filled with detritus and fibrin. A guidewire is inserted into the cavity through the endoscope's instrument channel. A VAC system is installed and positioned along the guidewire under endoscopic control. A device is used to insert the sponge. Sponge 1, sized to match the size and shape of the defect, is secured to the end of drainage tube 2 (nasogastric tube). To reduce the transverse size, sponge 1 is compressed along the entire perimeter of its outer lateral surface: sponge 1 is tied with thread 5, on which a self-dissolving knot 6 is formed, which unravels when end 7 of the thread is pulled; sponge 1 is inserted into silicone tube 4 (Overtube sleeve). , the transverse dimension of which is smaller than the size of sponge 1, and pushed, passing a flexible metal guide 3 in the form of a string into drainage tube 2, guiding guide 3, introducing sponge 1 through the organ cavity to the defect area. Sponge 1 was placed on the defect.Sponge 1 was released from silicone tube 4 and thread 5 was unraveled by pulling on end 7. Drainage tube 2 was connected to a vacuum pump, ensuring aspiration of pathological discharge from the defect through the organ cavity. Negative pressure in the defect allows for the removal of wound secretions, reduces tissue swelling, promotes blood flow, improves microcirculation, and promotes wound healing.

[0032] The device significantly reduces the time required for the procedure, reduces trauma to the mucous membranes, and allows for the installation of a sponge of the required diameter, increasing the effectiveness of vacuum therapy and shortening the patient's recovery period.

[0033] The claimed technical solution can be implemented using industrially produced devices and materials; its elements can be manufactured and assembled both in a handicraft manner and at modern industrial enterprises.

[0034] 1- sponge;

[0035] 2- drainage tube;

[0036] 3- conductor;

[0037] 4- silicone tube;

[0038] 5- thread;

[0039] 6- knot;

[0040] 7-end of thread. Patent literature

[0041] Patent RU 2734545

[0042] Patent RU 2562680l

Claims

A device for introducing a sponge for VAC therapy into an area of ​​interest, comprising a porous polyurethane sponge intended for aspiration of pathological discharge through an organ cavity, a drainage tube, the sponge being fixed at the end of the drainage tube, characterized in that it comprises a silicone tube intended to enclose the compressed sponge, a thread compressing the sponge, a knot being made on the thread that self-dissolves when the end of the thread is pulled; a flexible metal conductor installed in the drainage tube. A device for introducing a sponge for VAC therapy into an area of ​​interest, according to claim 1, characterized in that the silicone tube is an Overtube sleeve.

Citation Information

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