RU223518U1 - Device for removing foreign bodies of soft tissue under ultrasound control - Google Patents

Abstract

The utility model relates to medical instruments, namely to surgery, and can be used to remove soft tissue foreign bodies under ultrasound control. The device is formed by two mirror parts having jaws ending with handles with rings for the surgeon’s fingers and ratchet arms, while the distal ends of the jaws are made of an elongated and pointed shape, have notches and teeth on the inner gripping side, located every three notches at an angle of 45 degrees to the inner surface, while the gripping surface with notches and teeth does not exceed 2/3 of the length of the jaw. The inventive device can be successfully used in patients with injuries associated with both combat injuries - bullet or shrapnel, and domestic injuries - to remove bullets and fragments through small surgical accesses, most often equal to the diameter of the damaging element, with their subsequent evacuation.

Description

The utility model relates to medical instruments, namely surgical ones, and can be used in traumatology to remove foreign bodies of soft tissue under ultrasound control.

Local military conflicts in modern conditions are characterized by the widespread use of various methods and means of warfare using various highly effective weapons systems. A feature of combat trauma in these conditions is, in addition to bullet wounds, the predominance of multiple mine-explosive fragmentation wounds with simultaneous damage to various areas of the body.

Failure to remove foreign bodies promptly will result in acute or late complications such as allergy, inflammation or infection, which can be serious. Mine-explosive fragmentation wounds (MBFW) of soft tissues are characterized by the extent and depth of damage, inevitable primary bacterial contamination and often lead to the development of infectious complications. Traditional surgical removal of foreign bodies in patients with such soft tissue injuries is a fairly invasive and technically complex surgical intervention, which in some cases may fail, and is associated with the risk of serious complications. In this case, modern surgical technologies, which provide effective and safe removal of fragments from soft tissues with minimal trauma to the surrounding anatomical structures, become especially important.

One of the optimal options for solving this problem is the use of interventional radiology methods in the treatment of these patients, in particular the removal of foreign bodies of soft tissue under ultrasound (US) control. At the same time, performing a surgical procedure under ultrasound control has certain advantages over using a C-arm for the same purpose, since, in addition to the absence of radiation exposure, X-ray fluoroscopy does not allow clearly visualizing the passage of a surgical instrument through vascular and nervous structures, which significantly increases the risk of damage to them .

A device for removing foreign bodies from the bile ducts is known from the state of the art (RF patent No. 203393, published 04/02/2021), which contains a basket, the proximal part of which is made in the form of a dome, and the distal part is made of peripheral strings connected to a rod element, placed in a casing with the possibility of reciprocating movement; a central string made extended with the possibility of reciprocating movement in the casing, the proximal end of which is connected to the top of the dome; wherein the peripheral strings are made shortened with shape memory with the possibility of being placed in the casing in the transport position and having a convex shape in the working position, the proximal ends of the peripheral strings are connected to the base of the dome. The dome of the basket is made of elastic material with the ability to be placed in a transport position in the lumen of the casing together with the central and peripheral conductors and is equipped with holes and X-ray contrast marks located in the lower part of the dome. The connection of the proximal ends of the peripheral strings with the base of the dome is made atraumatic.

The disadvantages of this technical solution is the impossibility of using this device when removing foreign bodies of soft tissues, since when performing surgery to remove foreign bodies of soft tissues, the removal tool must have sharp ends and pass freely through soft tissues, especially to great depths.

From the significant level of technology, a tool for removing foreign ferromagnetic objects from wounds and body cavities is known (RF Patent No. 203097, published 03.22.21), which is a probe with a tip in the form of a magnet, characterized in that the device consists of a flexible probe with a controlled neodymium magnetic a head at the distal end and an external handle with controls for fixing the bending angle of the distal end of the probe in the required position.

The disadvantages of this technical solution is the use of this instrument during open interventions, when the surgical access is extensive and it is possible to freely insert the instrument into the wound, which cannot be done with surgical access from 5 mm to 10 mm, and insert it along the wound channel into the deep muscle mass.

An instrument for treating a wound cavity is known from the state of the art (RF patent No. 2565832, published on October 20, 2015), containing a fixing element and a working part, characterized in that the fixing element is shaped like the distal phalanx of a finger, made in the form of incomplete elastic rings or cylindrical sleeve, while the proximal end of the sleeve body is made of elastic material with thinning on the palm surface, is closed with a nut with a hole in the center with a diameter of 14, 16 and 18 mm and contains a seal that ensures the stability of the sleeve and safety during manipulation, the working part is located on the end side of the tool and has various options for removable or permanent cutting edges.

The disadvantages of this technical solution is the impossibility of using this device when removing soft tissue foreign bodies, since when performing surgery to remove soft tissue foreign bodies under ultrasound control, the surgical access is from 5 to 10 mm, and the diameter of the described instrument starts from 15 mm.

Of the existing devices, the closest technical solution, in our opinion, is forceps for opening and expanding the anastomosis of the sphenoid sinus (RF patent No. 2736319, published on November 13, 2020), with the function of removing pathological tissues, containing a longitudinal body with two handles, one of which is attached fixed to the body, and the other - hinged, characterized in that the tongs have two working parts at the distal end, with the upper one being longer than the lower one, through oval windows are made on the rounded ends of the working parts, and the handles of the device are connected to each other using a cylindrical hinge, and with a working surface - through a spherical hinge, with the possibility of transmitting the upper working part of the upper-lower movement in the plane of the body by squeezing the handles and returning them to their original position, the upper-lower movement is carried out using two lifting mechanisms.

The disadvantage of the prototype is the small working surface of the distal end of the instrument, which does not allow fixing foreign bodies of more than 15 mm, as well as the difficulty of passing the instrument through the aponeurotic tissue, due to its rounded ends, which is why it is necessary to apply pronounced efforts and traction to pass through the aponeurotic layer , which can subsequently lead to damage to the vascular or nerve bundles located below the aponeurosis due to uncontrolled pressure. A common disadvantage of all devices identified in the scientific and patent literature is the inability to adequately pass through soft tissues, more precisely the aponeurotic layer of muscles, as well as the muscles themselves, adding significant forces during attempts to insert instruments to a depth of more than 5 cm, the possibility of damage to great vessels and peripheral nerves, as well as the impossibility of using them through accesses from 5 to 10 mm.

The objective of the utility model is to develop a more effective and safe device for removing soft tissue foreign bodies under ultrasound control.

This problem is solved by the fact that the device for removing foreign bodies of soft tissue under ultrasound control is formed by two mirror parts having jaws ending with handles with rings and ratchets, while the distal ends of the jaws are made of an elongated and pointed shape, have notches and teeth on the internal gripping side , located every three notches at an angle of 45 degrees to the inner surface, while the gripping surface with notches and teeth does not exceed 2/3 of the length of the jaw.

The technical result provided by the above set of features is to facilitate the advancement of the device through soft tissues, which allows it to pass through the aponeurotic layers without much effort to capture and firmly hold foreign bodies of various configurations due to notches and denticles located in a certain way when removing foreign bodies of soft tissues under ultrasound control.

This technical result is achieved by the fact that the end part of the tool is represented by two jaws with an elongated and pointed upper working part, which has notches and teeth on the inside, located every three notches at an angle of 45 degrees to the inner surface, while the gripping surface has notches and teeth does not exceed 2/3 of the length of the branch. When the clamp handles are pulled apart, the upper working part opens, spreading the tissue apart, thereby expanding the channel for removing a foreign body, without cutting tissue or injuring it. Thus, the device is smoothly passed through soft tissues with minimal effort to pass through denser connective tissue structures. This allows you to reliably capture foreign bodies of various configurations: for this, when closing the clamp by bringing the handles together, the working upper part of the jaws is connected, capturing the foreign body with notches and teeth and holds it firmly due to notches and teeth located in a certain way. Thus, the design we developed ensures faster and less traumatic passage of FB through soft tissues under ultrasound control and minimizes the risk of trauma to subgaleal structures, with reliable capture and removal of the foreign body. The procedure is performed in real time, and the use of a small, compact instrument minimizes bleeding time and avoids damage to surrounding structures. This additionally provides an aesthetic effect.

The claimed device is illustrated by the following figures:

Fig. 1 - general view of the device;

Fig. 2 - working part of the jaws.

Detailed description of the device and examples of its clinical application

A device for removing foreign bodies of soft tissues under ultrasound control contains: 1, 2 - handles with rings for the surgeon's fingers, 3 - ratchets, 4, 5 - working jaws, 6 - notches, 7 - teeth, 8 - cylindrical axis.

The device for removing foreign bodies of soft tissues under ultrasound control is a surgical clamp formed by two mirror parts having handles 1 and 2 with rings for the surgeon’s fingers and with ratchets 3, thanks to which it is possible to fix the position of two working jaws 4 and 5. End/distal part of the jaws is made with an elongated and pointed upper working part, having on the inner gripping side notches 6 and teeth 7, located every three notches at an angle of 45 degrees to the inner surface, while the gripping surface with notches and teeth does not exceed 2/3 of the length jaws. Both jaws are connected by a cylindrical axis 8. The device is made mainly of titanium or stainless steel.

The device is used as follows. In the operating room, with the constant use of a portable ultrasound device RuScan 70P and a linear sensor L12-3E, after visualizing the evacuated foreign body and determining its diameter, local anesthesia is performed. Through a skin incision, which is determined intraoperatively, depending on the diameter of the foreign body being removed, it can vary from 5 mm to 30 mm; under constant ultrasound control, the inventive device is inserted into the soft tissue with the distal end with tightly compressed jaws 4, 5, and gradually moves to the installed depth, passing subcutaneous fat, aponeurotic layers and muscles, with periodic expansion using handles 1, 2 of jaws 4, 5 to expand the wound channel to the diameter of the evacuated foreign body. Upon reaching the surface of the foreign body, under ultrasound control, the jaws 4, 5 are pulled apart with a slight advance in depth, followed by the capture of the foreign body by the upper working part, which has notches 6 and teeth 7 on the inside. After compression of the foreign body by the working jaws 4 and 5 , it is firmly grasped by the teeth 7, the jaws 4, 5 are fixed by the ratchet 3 by bringing the rounded handles 1, 2 together with the surgeon’s fingers and with slow circular movements the foreign body is removed from the soft tissues.

The performance of the proposed device is confirmed by the following practical examples.

Example 1.

Patient K-ov was admitted to the surgical department on the 3rd day after receiving a shrapnel wound. An x-ray revealed a soft tissue foreign body 10 mm in diameter in the right thigh. When performing an ultrasound, its location was revealed in the thickness of the 4th femoris muscle, or more precisely in the intermedius muscle of the thigh, almost at the femur. The distance from the skin was up to 7 cm deep. The entrance hole was located 5 cm above the existing foreign body. It was decided to remove the foreign body under ultrasound guidance. In the operating room, with the constant use of the RuScan 70P ultrasound device and the L12-3E linear sensor, after visualizing the evacuated foreign body and determining its diameter and the atraumaticity of the route, local anesthesia is performed. Under constant ultrasound control, through a 10 mm skin incision, the working ends of jaws 4, 5 are inserted into the wound in a compressed position and advanced through the subcutaneous fat, fascia lata of the thigh and aponeurosis. Then jaws 4, 5 were spread to 1 cm, after which the instrument was further passed through the muscle layer. When contact with the surface of a foreign body is established under ultrasound control, jaws 4, 5 are pulled apart with a slight advance in depth and the foreign body is subsequently captured by the working surface with notches 6 and teeth 7. After compression of the foreign body by working jaws 4 and 5, it is firmly captured by the teeth 7, the jaws are fixed with ratchet clamps 3 by bringing the rounded handles 1, 2 together and with slow circular movements the foreign body is removed from the soft tissues, after which the wound is sanitized with antiseptic solutions, followed by drainage. The drainage is removed on the 2nd day after surgery, after which the wound heals by primary intention.

Example 2.

Patient M-ev was admitted to the surgical department on the 2nd day after receiving a bullet wound. When performing an x-ray in the projection of the pelvic bones, a foreign body of soft tissue 8 mm in diameter was revealed. When performing an ultrasound, its location was revealed in the thickness of the muscle mass of the left buttock, or rather between the gluteus medius and minimus muscles, closer to the piriformis muscle. The distance from the skin was 10 cm deep. The entrance hole was located on the back of the thigh, at a distance of 10 cm below the existing foreign body. It was decided to remove the foreign body under ultrasound guidance using the device we developed. In the operating room, with the constant use of the RuScan 70P ultrasound device and the L12-3E linear sensor, after visualizing the evacuated foreign body and determining its diameter, and ensuring that the route is atraumatic, local anesthesia is performed. Under constant ultrasound control, through a skin incision of 8 mm, the working ends of branches 4, 5 are inserted into the wound in a compressed position and advanced through the subcutaneous fat, fascia lata and aponeurosis. Then jaws 4, 5 were spread to 1 cm, after which the instrument was further passed through the muscle layer. When contact with the surface of a foreign body is established under ultrasound control, jaws 4, 5 are pulled apart with a slight advance in depth and the foreign body is subsequently captured by the working surface with notches 6 and teeth 7. After compression by working jaws 4 and 5 of the foreign body, it is firmly captured by the teeth 7, the branches are fixed by ratchet 3 by bringing together the rounded handles 1, 2 and with slow circular movements the foreign body is removed from the soft tissues. The wound is sanitized with antiseptic solutions, followed by drainage. The drainage is removed on the 2nd day after surgery, after which the wound heals by primary intention.

The results of using the inventive device have shown that when moving the device through soft tissue, it does not require much effort to pass through the aponeurotic and muscle layers, which allows the device to be moved more quickly and non-traumatically to a foreign body. The data obtained were confirmed by clinical practice. The inventive device can be successfully used in patients with injuries associated with both combat injuries - bullets or shrapnel, and household ones - to remove bullets and fragments through small surgical accesses, most often equal to the diameter of the damaging element, with their subsequent evacuation.

The inventive device for removing foreign bodies of soft tissues under ultrasound control makes it possible to remove, including non-radiographically contrasting bodies, from soft tissues in a complex anatomical area, and to reduce the invasiveness of passage through soft tissues.

The device is made of wear-resistant material, is easily sterilized and can be used repeatedly in surgical practice.

It significantly facilitates surgical procedures, including outpatient procedures, when removing a foreign body from soft tissues. The procedure is performed in real time, and the use of a small, compact instrument minimizes bleeding time and avoids damage to surrounding structures. This additionally provides an aesthetic effect.

The proposed device for removing soft tissue foreign bodies under ultrasound control has been tested in the clinic and can be recommended for widespread use in surgical hospitals.

Claims (1)

A device for removing foreign bodies of soft tissue under ultrasound control, containing two working parts at the distal end and two handles, characterized in that it is made in the form of two mirror parts having jaws ending with handles with rings and ratchets, while the distal ends of the jaws are made elongated and pointed in shape and have notches and teeth on the inner gripping side, located every three notches at an angle of 45 degrees to the inner surface, while the gripping surface with notches and teeth does not exceed 2/3 of the length of the jaw.