RU2738627C1 - Semi-automatic needle for trepan-biopsy of pancreatic head tumours and distal portion of choledochus - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention relates to oncology and oncoradiology. Semiautomatic needle for trepan-biopsy of pancreatic head and distal head tumours includes a cannula with length of 20–35 cm, diameter of 14-21G, a stylet with length of 20–35 cm, a body consisting of a support for the surgeon's fingers and a plunger. Housing is equipped with a screw-type fixing device with internal thread, the cannula and stylet are made of a flexible material and have a hydrophilic coating from the outside.EFFECT: invention can be used for trepan-biopsy of pancreatic head and distal choledochus tumours.1 cl, 2 dwg

Description

The invention relates to oncology and oncoradiology and relates to a needle for puncture trephine biopsy of tumors of the pancreatic head (PG) and distal choledochus (DOC), compatible with a device for puncture trephine biopsy of tumors of the pancreatic head and distal choledochus (patent for invention No. 2722655 dated 05/13/2019, the date of state registration in the State Register of Inventions of the Russian Federation 06/02/2020 Authors: Revazov E.B., Khutiev Ts.S., Revazova M.R.).

In the pre-icteric period, diseases are secretive, and it is rarely possible to diagnose HPV and DOC cancer. Obstructive jaundice occurs in 50-95% of patients (Yu.I. Patyutko, A.G. Kotelnikov, 2007, V.A.Kubyshkin, V.A.Vishnevsky, 2007). The therapeutic and diagnostic algorithm in this group of patients is a series of sequential actions, one of the links of which is the puncture trephine biopsy. Cytological diagnosis by brush biopsy and puncture aspiration biopsy has limitations and does not allow obtaining 100% informational content of the diagnosis, and does not give an answer on the histological structure of the tumor.

Known is a single aspiration-cutting needle with a plastic adapter 0.8-1.6 mm in diameter, 12-24 cm long with Franseen sharpening (the needle tip is sharpened in the shape of a crown to be suitable for working with fibrous formations) and ultrasonic marks on the working part the barrel of the needle. Transparent plastic adapter LUER-LOCK type. Stylet with triangular sharpening and ultrasonic marks on the working end of the stylet. (V.G. Ivshin., 2016 // Original techniques of percutaneous invasive interventions on the abdominal organs; p. 143).

The disadvantage of this device is that the needle has a rigid design that does not allow it to overcome the bends of the puncture cholangiostomy canal of the liver. The manual method of use does not allow achieving the required speed of the needle movement and, accordingly, obtaining high-quality histological material.

There is also a needle for soft tissue biopsy containing an outer hollow needle with an oblique cut at the working end and an inner hollow needle with a handle, characterized in that, in order to simplify the design, the cutting edge of the inner hollow needle is made in the form of a spiral on the outer surface of this needle a groove is made in which a flat springy knife is installed. (SU 848016 A1, Butenko Ivan Stepanovich // 1981.07.23).

The disadvantage of this needle is its rigidity, which does not allow to pass the bends of the cholangiostomy canal.

The prototype of the present invention is a semi-automatic biopsy needle, which consists of a cannula and a stylet with a biopsy chamber ("window"), a support for the surgeon's fingers and a plunger to advance the stylet and release the biopsy mechanism. (Kulezneva Yu.M., Percutaneous interventions in abdominal surgery, M .: Publishing group "GEOTAR-Media", 2016, pp. 105-107).

The disadvantage of this needle in the case of its use with a device for puncture trephine biopsy of tumors of the pancreatic head and distal choledochus (patent for invention No. 2722655) is that it does not have sufficient flexibility. The transhepatic cholangiostomy canal is not straight. Angles formed in the canal, due to the anatomy of the biliary tract and puncture access, lead to a bend of the biopsy needle. The stiffness of the needle increases the lateral friction between the cannula and the wall of the puncture canal of the trephine biopsy device, as well as between the cannula of the needle and its stylet. The friction force does not allow the semi-automatic needle to develop the required speed and range of motion to obtain high-quality histological material.

The purpose of the invention is to create a semi-automatic needle compatible with a device for puncture trephine biopsy of tumors of the pancreatic head and distal choledochus (patent for invention No. 2722655) to obtain histological material from different places and depths of tumors of the pancreatic head and distal choledochus.

This goal is achieved by the fact that the proposed invention - a semi-automatic needle for trepan - biopsy of tumors of the head of the pancreas and the distal section, includes a cannula 20-35 cm long and 14-21G in diameter, a stylet 20-35 cm long, a body consisting of a finger rest surgeon and plunger.

New in the claimed technical solution is that the body is equipped with a screw-shaped fixation device with an internal thread, which allows rigidly fixing the semi-automatic needle to the device for trephine biopsy of tumors of the pancreatic head and distal common bile duct, facilitating the process of taking trephine biopsy and simultaneously reducing the risk of injury internal organs. The execution of the cannula and stylet from a flexible material facilitates the passage of the needle along the bends of the puncture transhepatic cholangiostomy canal. The hydrophilic coating of the outer surface of the cannula and stylet reduces the force of lateral friction of the cannula against the stylet and the wall of the puncture device for trephine - biopsy.

FIG. 1A shows a semi-automatic biopsy needle, consisting of a plunger to advance the stylet and release the biopsy mechanism [1], the surgeon's finger rest [2], a flexible cannula and a flexible stylet with a biopsy chamber [3], a screw fixing device [4], with an internal thread compatible with the LUER / LUER-LOCK syringe connector [5] of the trephine biopsy device shown in FIG. 2. The distal 25 mm stylet has a standard stiffness, which avoids axial deflection of the stylet during its penetration into the tumor tissue.

FIG. 1B shows a flexible cannula with a cutting edge [5].

FIG. 1B shows a flexible stylet with a biopsy chamber, the distal region [6] having standard stiffness over 25 mm, while the middle and proximal regions [7] are flexible. The cannula and stylet are covered with a hydrophilic material outside [8]. The length of the cannula with the stylet is 5 mm longer than the puncture canal of the device for puncture trephine biopsy of tumors of the pancreatic head and distal common bile duct (patent for invention No. 2722655) and is 20-35 cm. The diameter of the needle is from 21 to 14G.

FIG. 2 shows a semi-automatic biopsy needle fixed on a universal device for trephine biopsy of tumors of the pancreatic head and distal common bile duct [4] (patent for invention No. 2722655 dated 05/13/2019, date of state registration in the State Register of Inventions of the Russian Federation on 06/02/2020). The body of the semi-automatic needle [1] is fixed to the connector part [5] of the puncture canal of the biopsy device by means of a screw fixing device [2] with a female thread, through which the cannula of the needle with the stylet [3] passes. A super-rigid metal conductor was passed through the conductor channel of the trephine biopsy device [6].

The device works as follows. Before performing a puncture biopsy, the size of the tumor, the ratio of its nearby structures, the extent of occlusion according to the data of computed tomography with contrast enhancement and / or magnetic resonance imaging with cholangiography are determined. Then, through the percutaneous puncture canal of the liver parenchyma through the hepaticoholedoch into the duodenum (duodenum), the patient is injected with a metal super-rigid conductor [6] (Fig. 2) of the Lunderquist type 0.035 "- 0.038". At the same time, the entire soft part of the conductor and the distal end of its hard part are inserted into the duodenum, which allows maintaining the rectilinear axis of the common bile duct. Through a metal conductor installed in the canal, the device [4] is inserted into the hepaticoholedochus, thereby bougie the puncture canal of the liver. Further, the distal end is brought up as much as possible through the narrowing zone along the true lumen of the common bile duct, expanding it so that the internal opening of the puncture canal reaches the proximal part of the tumor stenosis. The addition of the stiffnesses of the conductor and the device provide a straight axis in the operation zone. The direction and depth of the puncture is selected based on the preoperative CT and MRI analysis. The direction of the puncture is set by rotating the device around the axis of the guidewire [6]. Trephine biopsy is performed using a 21-14G semi-automatic biopsy needle. The optimum diameter is 18-20G, which allows obtaining a high-quality tissue column with a low risk of complications in the form of bleeding. The needle is pre-moistened with saline in order to activate its hydrophilic coating. The needle is fixed on the connector [5] (Fig. 2), providing the simultaneous extension of the needle from the puncture canal of the device and its insertion into the tumor tissue to a depth of 3-5 mm. This ensures that the cutting of the tissue column begins deep in the tumor, thereby reducing the risk of bleeding. The very fact of fixing the semiautomatic needle to the trephine biopsy device allows for more efficient tissue sampling due to rigid retention of the structure: the trephine biopsy device with one hand, and the semiautomatic biopsy needle with the other hand. After puncture, the needle is removed. The cannula is pulled out again, the resulting material is placed in a formalin solution and sent for research. If necessary, puncture trephine biopsy is repeated up to 3-5 times. For the prevention of hematogenous and implantation metastasis after puncture through the puncture canal using a syringe of the LUER / LUER-LOCK type connected to the connector [5], anticancer drugs are administered. Then, percutaneous transhepatic external-internal drainage of the bile ducts is performed, providing compression of the puncture canal of the tumor and preventing bleeding.

The safety of the device allows performing targeted biopsy of tumors of the head of the pancreas and the distal part of the common bile duct with minimal risks when performing the intervention by one surgeon, as at the stage of drainage of the bile ducts, which significantly reduces the operation time with a 100% probability of obtaining histological material.

Claims (1)

Semi-automatic needle for trephine biopsy of tumors of the head of the pancreas and distal section, including a cannula 20-35 cm long, 14-21G in diameter, stylet 20-35 cm long, a body consisting of a stop for the surgeon's fingers and a plunger, characterized in that the body equipped with a screw-shaped locking device with an internal thread, the cannula and stylet are made of flexible material and have a hydrophilic coating on the outside.

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