RU129378U1 - DEVICE FOR EXTREMELY LIVER FUNCTION - Google Patents

Abstract

Device for emergency puncture of the liver, including a catheter, a pointed metal pointed arrow and a metal stylet with a needle element located in another catheter, characterized in that it contains a hollow metal guide inserted into the lumen of the first catheter made of reinforced plastic and having a curved end with the ability to change the angle of bend, it also contains a second plastic catheter with a support flange and a thread inside at the proximal end, installed in the lumen Ola metal guide, a puncture needle at the distal end of which is threaded cone-shaped element, and which is mounted in the lumen of the catheter and the second plastic is rigidly fixed to the support flange.

Description

The utility model relates to medical instruments, namely to instruments for endovascular surgery and can be used for emergency liver puncture.

According to the WHO, chronic diffuse liver diseases cause the death of about 1 million people per year, and in the next decade the number of patients suffering from cirrhosis will increase by more than 60% [Mayer K.-P., 2000; Gusev D.A., 2001; Hui A.Y., et al., 2002; Gish R.G., 2004]. The main cause of death in these patients are complications of portal hypertension such as bleeding from varicose veins of the esophagus and hepatorenal syndrome. The most effective method of surgical treatment of portal hypertension is trans-jugular (trans-jugular) intrahepatic port-systemic shunting (TIPS / TIPS) [Arun J. et al., 2005].

When performing an extrahepatic intrahepatic port-systemic shunting operation, an important step in the surgical aid is the puncture of the parenchyma of the liver and the walls of the shunted vessels at strictly established points and the subsequent formation of the intrahepatic canal connecting the right hepatic vein with one of the branches of the portal vein.

With a pronounced fibrotic process that accompanies any form of cirrhosis of the liver, and especially pronounced with cirrhosis of alcoholic and toxic etiology, the formation of such a channel can be very difficult, which leads to a decrease in the effectiveness of the intervention, and sometimes even to the impossibility of its implementation [Shipovsky V.N. 2010].

In domestic and foreign literature, we have found medical devices for liver puncture, which allow the formation of an intrahepatic canal.

A device for sampling tissue with a biopsy cannula "(Germany, wz.N3924291 from 01/31/91).

The device comprises: a housing, a needle element located therein, an outer tube (cannula) surrounding the needle element, an input node for collecting a tissue sample, which simultaneously introduces the needle element and the outer tube into the fabric; the input unit has 2 slide elements movable along the same axis, of which the rear slide element carries a needle element in the input direction, and the slide slide front element carries the next slide element that can move against the front slide element and which carries the outer tube (cannula). There are 3 springs: the first spring loads both of the slide elements offered on the same axis in the direction of entry, being located between the honey body and the rear end face of the slide element carrying the needle element. The front slide element in the input direction has an abutment for the next slide element. The other spring is clamped with tension between the two sliding elements moving along the same axis and reaches the front sliding element with the element carrying the outer tube. The third spring is placed between the last focus on the second slide and the slide carrying the outer tube. There are locking latches as splitters for the slide elements: the first latch is located on the housing and works at the very beginning of the sampling process, then remaining in the lock, and the slide becomes a fixed support for the next slide. Other latches are placed on the above-mentioned slide with the possibility of operation. As a regulator of the stroke of the outer tube (cannula), stops are used that can be adjustable.

This device, originally intended for liver biopsy, allows, as can be seen from its design, to form the intrahepatic canal, however, the instrument has significant disadvantages:

1. The complexity and bulkiness of the design.

2. The device has low operational characteristics due to the presence of a large number of locking elements, and, therefore, involves many manipulations, which complicates the procedure as a whole.

3. This tool allows you to form the intrahepatic canal, but is not applicable for the operation of TIPS / TIPS.

A device for percutaneous liver biopsy is known (RF Patent No. 2021770, 10/30/94), characterized in that it contains a hollow handle, placed in it coaxially with an external cylindrical knife and an internal puncture needle with a holder and an annular recess for biopsy with the possibility of translational movement ; a knife translational movement mechanism comprising a coil spring with a release lever and a support washer freely mounted on the housing; a rotational movement mechanism of the knife, comprising a handle, a latch kinematically connected with a lever of the translational movement mechanism of the body; mechanism of longitudinal vibrations of a cylindrical knife.

However, the device has disadvantages:

1. The complexity of the design and the complexity of maintenance.

2. The inability to use this device for emergency liver puncture.

A device for puncture biopsy of organs and tissues (RF Patent No. 2234270 dated 01/09/2003) containing a needle consisting of 4 parts is known: a sleeve with an outer diameter of 2.7 mm, in the channel of which a stylet with a stop or a probe with a mandrel is tightly placed . The stylet in the form of a rod has an emphasis and an oblique cut of the working end. The probe is made in the form of a hollow tube, at the end of which there are two rounded petals with external sharpening. Mandrain obturating in the form of a core.

This device has disadvantages:

1. The tool is not applicable for emergency puncture of the liver, which is a stage of TIPS / TIPS.

2. There is a high likelihood of developing intraparenchymal hematomas with damage to large intrahepatic vessels.

A device for a liver biopsy is known (RF Patent No. 11046 from 09.16.1999) containing a needle, characterized in that it has two hollow needles: an external and an internal one with a lateral notch, the external needle being screwed to the fixed part of the device, and the internal needle to the movable part of the device, which moves relatively stationary, both of these parts have rings for the fingers.

The disadvantages of this device:

1. This tool is not applicable for TIPS / TIPS surgery at the stage of puncture of the liver parenchyma.

2. The inability to accurately puncture a specific area of the liver.

A device for puncture biopsy of the liver (US Patent No. 200299307 dated 07.25.2002) containing a hollow body in which the trigger mechanism, the external cannula and the internal stylet are known. The cannula is interconnected with the slider 1, the stylet is with the slider 2. The slide 1 and 2 are mounted one above the other and have a common longitudinal sliding surface relative to each other. The springs installed one in the other abut against the bottom of the body, interacting with the other ends with the corresponding sliders 1 and 2. The sliders 1 and 2 are made in the form of two semi-cylindrical elements and have a common sliding surface, offset relative to the axis of the coaxial cannula and stylet. A fixing handle equipped with a trigger is attached to the body of the device.

The device has several disadvantages:

1. The complexity of the design, which causes significant difficulties in operation and sterilization.

2. The inability to use for emergency liver puncture.

3. The inability to project the exact direction of the puncture channel in the process of manipulation.

4. Creating a channel in the liver tissue affected by the cirrhotic process presents great difficulties.

A Haskal Transjugular Intrahepatic Access Set (Hoppe H, Wang SL, Petersen BD. Intravascular US-guided direct intrahepatic portocaval shunt with an expanded polytetrafluoroethylene-coated stent-graft. Radiology 2008; 246: 306-314) known, consisting of from a hollow metal needle placed in a plastic casing. There is an indicator arrow at the proximal end of the needle showing the rotation angle of the needle. The distal end of the needle in the 80 mm section is not covered. The needle part of the needle has an oblique section of 45 °. A stylet - catheter is placed in the cavity of the needle.

This device has disadvantages:

1. Often, when performing a puncture of a cirrhotically changed dense liver tissue, the distal part of the needle is deformed and bent, which does not allow creating an intrahepatic canal with a given direction.

2. The creation of a precisely projected port-system channel in a cirrhotically altered liver parenchyma presents significant difficulties, which often requires multiple puncture attempts.

3. The presence of an oblique cut and a significant diameter of the needle increase the risk of damage to the vascular and duct structures at the puncture stage.

Closest to the claimed and selected as a prototype is the Rösch-Uchida needle [Hulek P., Kraina A. Current practice of TIPS.// Progresstick Hradek Kralove, Chech republic, 2001], with which an emergency liver puncture is performed.

The Rösch-Uchida needle includes a metal catheter located in a plastic casing; there is an indicator arrow at the proximal end of the catheter showing the rotation angle of the Rösch-Uchida needle; there is a through hole at the distal end of the catheter. The Rösch-Uchida needle at the puncture stage is located in the introducer with a diameter of 12.5 F. A metal stylet is inserted through the proximal opening of the Rösch-Uchida needle located in a plastic catheter with a diameter of 5.2 F with the possibility of longitudinal movement along the needle length. The stylet needle element at the stage of puncture of the parenchyma is located up to 80 mm distal to the final portion of the Rösch-Uchida needle. After the puncture of one of the branches of the portal vein is carried out, the stylet is removed from the plastic catheter.

However, the prototype has its drawbacks:

1. With severe fibrosis of the liver tissue, causing its high density, which is especially pronounced with cirrhosis of toxic or alcoholic etiology, it is difficult to perform a puncture of the parenchyma. This requires repeated attempts to perform a puncture, which often causes damage to the vascular and ductal structures of the liver.

2. When performing a puncture of a cirrhotically changed dense liver tissue, the distal part of the needle is deformed and bent, which does not allow creating an intrahepatic canal with a given direction.

3. The inability to accurately puncture the desired point of the portal vein branch due to the “recoil” phenomenon due to the insufficient elasticity of the Rösch-Uchida needle, which makes it necessary to repeatedly puncture the liver parenchyma and the wall of the shunted vessel.

4. The inability to create an intrahepatic canal at a certain angle with respect to the main portal vein trunk, depending on the individual characteristics of the intrahepatic porto-caval vascular system, which is necessary to obtain optimal hemodynamic characteristics of blood flow in the stent.

The objective of the present invention is to provide a device for the emergency puncture of the liver and intrahepatic bypass vessels, the result of which is the formation of a precisely designed port-system channel with minimal trauma to the liver tissue, the absence of trauma to the intrahepatic vascular and duct systems, which allows to obtain optimal blood flow characteristics inside the stented channel.

The problem is solved in that the device for emergency puncture of the liver contains a hollow metal guide mounted in the lumen of the first catheter made of reinforced plastic, and having a curved end with the ability to change the bend angle, it also contains a second plastic catheter with a support flange and a thread inside on the proximal end mounted in the lumen of the hollow metal guide; a puncture needle, at the distal end of which there is a threaded element of a cone shape, and which is installed in the lumen of the second plastic catheter and is rigidly fixed with a support flange. This allows you to create a precisely projected intrahepatic port-system channel in each individual case, which results in optimization of hemodynamic characteristics of the blood flow in the installed stented channel and prevention of vascular complications of portal hypertension in the postoperative period.

The technical result of the developed device is to reduce the number and severity of intraoperative complications of the operation of an extrajugular (transjugular) intrahepatic porto-systemic bypass and reducing the likelihood of thrombosis of the intrahepatic stent by creating an intrahepatic canal, the position of which takes into account the anatomical features of the angioarchitectonics of the porto-caval vascular system and stage.

A causal relationship between the features of the utility model and the technical result is that the presence of a reinforced first plastic catheter, a hollow metal guide with the ability to change the bending angle of the distal end and the threaded element of the puncture needle allows precise puncture of the liver tissue at the set points and, as a result, to form a pre-projected intrahepatic port-system channel at the diagnostic stage of the surgical manual in the absence of vascular trauma stoic and duct structures.

The device is illustrated in the drawing (Fig.1-4), which shows the details of the device in sections.

Device Description:

1 - the first plastic catheter

2 - retainer of the first plastic catheter

3 - hollow metal guide

4 - curved end of the guide

5 - metal pointed arrow

6 - second plastic catheter

7 - supporting flange of the second plastic catheter

8 - thread of the support flange

9 - puncture needle

10 - the handle of the puncture needle

11 - threaded element of the puncture needle

12 - nitinol braiding of the puncture needle

13 - plastic hollow conductor - dilator

The proposed device contains: the first plastic catheter 1 (Figure 1) with a diameter of 2.3 mm and a length of 589 mm; with a latch 2, the catheter is made of reinforced plastic to give rigidity to the structure;

a hollow metal guide 3 (Figure 2) with a diameter of 2.2 mm, a length of 589 mm, which is installed in the lumen of the first catheter 1 and is rigidly fixed using the latch 2; the distal end of the guide 3 has a curved end 4 with the possibility of changing the angle of bending; at the proximal end of the hollow metal guide 3, a metal pointed arrow 5 is fixed to determine the angular direction of the end of the guide 3;

a second plastic catheter 6 (FIG. 3) with a diameter of 1.7 mm and a length of 641 mm with a supporting flange 7 (dimensions 26 × 16 mm) and a thread inside 8 at the proximal end; the second plastic catheter 6 is installed in the lumen of the hollow metal guide 3 and is made with the possibility of sliding coaxial reciprocating movements in the proximal and distal directions and translational-rotational movements about its axis; its distal part up to 40 mm long extends beyond the distal part of the hollow metal guide when performing puncture;

a puncture needle 9 (Figure 3) with a diameter of 1.6 mm, a length of 651 mm with a handle 10 at the proximal end; a puncture needle 9 is installed in the lumen of the second plastic catheter 6 and is rigidly fixed by the handle 10 to the support flange 7 using thread 8, in order to prevent longitudinal displacements of the puncture needle relative to the second plastic catheter 6; on the distal end of the puncture needle 9 is a threaded element 11 of a conical shape 4 mm long with a right-hand thread in 0.15 mm increments, with the possibility of extending beyond the distal end of the second plastic catheter 6 to the entire length of the threaded element 11; the distal end of the puncture needle 9 has a variable diameter from 1.6 mm to 1.1 mm and a tightly fixed nitinol braid 12 to impart rigidity in the transverse and longitudinal directions;

a plastic hollow conductor-dilator 13 (Figure 4) with a diameter of 2.2 mm and a length of 720 mm; installed in the lumen of the first plastic catheter 1.

The device is used as follows.

In the X-ray operating room, the patient is placed on the operating table with a head turn to the left. After skin anesthesia with a solution of novocaine 0.5% - 10 ml, the internal jugular vein is punctured at the middle of the distance between the angle of the lower jaw and clavicle along the front edge of the sternocleidomastoid muscle and an angiographic conductor with a diameter of 0.035 '' is inserted under x-ray control, set in the lower vena cava in the suprarenal section. An introducer with a diameter of 12.5 F is installed along a conductor with a diameter of 0.035 '', so that the marked distal part is in the area of the mouth of the inferior vena cava. Then, the first plastic catheter 1 is inserted into the lumen of the introducer with a diameter of 12.5 F along a conductor with a diameter of 0.035 '', the right hepatic vein is catheterized. Selective cavagraphy is performed to determine the anatomical features and patency of the right hepatic vein. At the same time, reverse mesenteric portography (indirect portography) is performed by puncture of the right femoral artery according to Seldinger. The totality of the data obtained during selective cavagraphy and reverse mesenteric portography makes it possible to clearly represent the X-ray anatomical features of the right hepatic vein and the right main branch of the portal vein in the context of the upcoming extra puncture of the liver. After that, the hollow metal guide 3 is installed in the lumen of the first plastic catheter 1 and fixed in it using the latch 2. Then this tool block is installed in the right hepatic vein so that the curved end 4 of the hollow metal guide 3 is 2.5 cm from the mouth its flow into the inferior vena cava, while the metal pointed arrow 5 should be located at an angle of 45 ° in the front-upper direction. This arrangement of the pointed arrow 5 allows you to visually control the path of the puncture channel during manipulation and hold the hollow metal guide in a strictly specified direction. On a fixed indirect portogram and selective kawagram, the direction and location of the port-system channel are projected. A second plastic catheter 6 is inserted into the hollow metal guide 3 with the puncture needle 9 fixed in it using the thread 8 of the support flange 7. Using the handle 10, the translational needle 9 is aligned with the second plastic catheter 6 clockwise through the hepatic vein wall and further puncture of the parenchyma by reciprocating manipulations in a predetermined topographic and anatomical direction in the direction of one of the main branches of the portal vein. Liver puncture is performed using the principle of the “corkscrew” action using the threaded element 11 of the puncture needle 9. The use of this principle makes it possible to form a channel in a dense liver parenchyma due to cirrhosis. Nitinol braid 12 of the puncture needle 9 prevents its bending in the transverse directions, which ensures that the threaded element 11 of the puncture needle 9 does not deviate from the intended path. Leaning against the wall of one of the main branches of the portal vein, repeated translational-rotational movements of the puncture needle 9 with the second plastic catheter 6 are performed clockwise to penetrate into its lumen so that the distal section of the second plastic catheter 6 is located in the cavity of the punctured vessel. Then, the puncture needle 9 is removed so that the second plastic catheter 6 remains in the lumen of the punctured branch of the portal vein. After that, a standard conductor with a diameter of 0.035 '' is guided through a plastic catheter 6 into this branch and then into the main trunk of the portal vein, a second plastic catheter 6 is removed and a plastic hollow conductor - dilator 13 is inserted through the conductor in order to buzz the created port-system intrahepatic channel.

The inventive device can be made industrially and find widespread use in medicine for transjugular intrahepatic port-systemic bypass surgery, i.e. it meets the criterion of "industrial applicability".

The performance of the claimed device is confirmed by the following clinical examples:

Example 1. Patient S., 65 years old. Case history No. 003456/788. Was admitted to the clinic on December 1, 2010. The main diagnosis: Cirrhosis of the liver of alcoholic etiology.

Complications of the main diagnosis: Chile-Pugh class B chronic liver failure, varicose veins of the esophagus 3 tbsp., Bleeding from varicose veins of the esophagus, compensated posthemorrhagic anemia, splenomegaly, grade 1 hepatic encephalopathy.

The patient noted three episodes of bleeding from varicose veins of the esophagus in history. Recurrent varicose bleeding of portal genesis was an indication for surgical intervention - transjugular intrahepatic port-systemic shunting (TIPS / TIPS).

The patient was operated on 3.12.2010. Operation: Intrahepatic intrahepatic portosystemic shunting (TIPS / TIPS) using the developed original device.

Using synchronous cavagraphy and reverse mesenteric portography performed in the sagittal and frontal planes, the topographic and anatomical trajectory of the planned intrahepatic port-system channel is projected. Using the original device allowed us to create the specified channel in the liver parenchyma significantly densified due to cirrhosis and stent it. The stent is located at an angle of 110 ° relative to the main trunk of the portal vein, which was optimal for this patient in order to create better blood flow characteristics.

At the control planned examinations in the period from 1 to 18 months with a frequency of 3 months, the patient's condition remained stable, quite satisfactory. Over the entire period of observation of recurrence of esophageal-gastric bleeding was not noted. During control fibroesophagogastroscopy, a positive trend was observed in the form of a decrease in the degree of varicose transformation of the esophagus veins and cardiac section of the stomach. Despite pathological changes in the coagulogram, both in the side of hypo- and hypercoagulation of blood due to chronic liver disease, no stenosis and stent thrombosis were detected during control ultrasound duplex scans of the portal vein system. This confirmed the optimal topographic and anatomical location of the stent, which made it possible to create the best conditions for the hemodynamic characteristics of the blood flow in it in this clinical case.

Conducted surgical treatment and positive dynamics of the patient's condition confirmed the high technical efficiency of the developed original device in the treatment of patients with complicated forms of portal hypertension of cirrhotic origin.

Using the inventive device for the emergency creation of an intrahepatic port-systemic channel, 40 patients with complicated forms of portal hypertension of cirrhotic origin were operated on.

The advantages of the device are that it allows you to effectively perform a puncture of the hepatic parenchyma and create an intrahepatic port-system channel in the liver tissue, which is significantly densified due to the cirrhotic process, with a view to its subsequent stenting for portal decompression, which provides prophylaxis and treatment of complications of portal hypertension.

Claims (1)

Device for emergency puncture of the liver, including a catheter, a pointed metal pointed arrow and a metal stylet with a needle element located in another catheter, characterized in that it contains a hollow metal guide inserted into the lumen of the first catheter made of reinforced plastic and having a curved end with the ability to change the angle of bend, it also contains a second plastic catheter with a support flange and a thread inside at the proximal end, installed in the lumen Ola metal guide, a puncture needle at the distal end of which is threaded cone-shaped element, and which is mounted in the lumen of the catheter and the second plastic is rigidly fixed to the support flange.

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