RU2432917C2 - Universal method of intraduct destruction of stones, release of trapped by concrement in bile ducts dormia basket and lithotripter basket and device for its realisation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to surgery and can be applied for intraduct destraction of stones in case of trapped by stone Dormia basket and (or) lithotripter basket. Intraduct release and removal of trapped by stone Dormia basket and (or) lithotripter basket is performed. As guide for access into choledoch lumen trapped basket is used. Proximal end of trapped basket is disconnected from manipulator, brought into armed triptor sheath and fixed in it. Armed triptor sheath is brought to concrement as far as it would go along trapped basket. Traction effort up to 150 kG, sufficient for destruction of trapped basket and (or) concrement is created in triptor. Device for intraduct destruction of stones contains manipulator and working part, additionally containing triptor, which includes immovable frame, wheel, screw, movable flange and clip.

EFFECT: method makes it possible to create essential effort, avoid open access for removal of trapped basket.

7 cl, 4 ex, 2 dwg

Description

The invention relates to medicine, namely to x-ray endoscopic interventions on the biliary system.

Diagnosis of such a complication of cholelithiasis as colledocholithiasis is most effective using the X-ray endoscopic method (SEM). In addition, SEM allows the resolution of choledocholithiasis in one study. For the extraction and destruction of stones, the use of various types of mechanical lithotripters is effective. The baskets of these devices (Cook priority No. US 2008/0969056, 2008.01.03; US 2007/0880222 P, 2007.01.12; Olympus priority No. JP 2002/0204366, 2002.07.12 as a prototype) allow performing intra-ductal destruction of the calculus and subsequent extraction of its fragments into the lumen of the duodenum.

Known devices have serious disadvantages. Firstly, there are known cases of their destruction due to the density of the stone; We noted several cases of destruction of the distal part of the lithotripter basket in the handle at the time of lithotripsy. Further use of the device as a result of breakdown becomes impossible, and the basket restrained in the lumen of the common bile duct implies a transition to an open operation. The need for such tactics is due to the fact that the basket cable fixed in the handle has a special design that excludes its use in devices of other manufacturers, and after destruction, in the original one.

The second serious drawback of the devices described above is also that their introduction into the endoscope channel is fully assembled, and replacement of lithotripter elements during X-ray endoscopic examination and manipulations is impossible.

The third serious drawback of the known devices is as follows: when using a Dormia basket (unreinforced type) for stone extraction, an infringement of the calculus often occurs in it, when its release becomes impossible. Among the reasons can be noted the significant size of the stone, its loose structure, the mismatch between the size of the stone and the duct or choledocho-duodenal anastomosis. Since the purpose of the Dormia basket does not imply the possibility of destruction of the stone, the following algorithm of actions is compulsorily performed: the device handle is destroyed, the endoscope is removed, and the patient undergoes an open-access operation related to gluttony, and therefore injury. During surgery, the patient undergoes laparotomy, choledochotomy, extraction of restrained stone and instrument. Given that these patients are usually 60 years old or older, the risk of intra- and postoperative complications increases dramatically.

As experience shows, all the described situations are common in surgical practice. They are dangerous in that the operation performed according to indications in a minimally invasive way ends in a cavity, which entails serious risks and complications for the patient, as well as disability (fatal outcomes are also possible). At the same time, the most promising (and sparing for patients) area of minimally invasive surgery is discredited. New techniques require new tools that are free from the drawbacks described above.

The objective of the invention is to provide a tool that allows you to use all types of baskets for mechanical lithotripsy, as well as for the destruction of stones trapped in the basket, which cannot be disposed of in any other way, except for abdominal surgery.

This goal is achieved in that the device is made in the form of a structure (Fig. 1, 2), consisting of a manipulator (triptor) (1) and a reinforced braid (2) with a reinforced distal end (3). Triptor (1) contains a fixed (non-separable) part or frame (4) and a movable (5). The frame (4) contains two supporting fingers (6) along which the movable part (5) of the tryptor (1) moves. The moving part consists of a flywheel (7), a screw (8) with a flange (9) and a clamp (10) fixed to it to fix the cable (11) of the restrained (destroyed) basket (12). The design of the clamp 10) provides rigid fixation of the destroyed cable of the basket (12), regardless of its length and diameter. The flywheel (7) transfers the force to the screw (8), which, with the help of the movable flange (9), moves slowly along the support fingers (6) of the frame (4). The small thread stroke on the screw (8) and the flywheel (7), which is less than 1 mm, allows increasing the pressure on the distal end (3) of the braid (2) gradually. At the same time, the resulting effort significantly exceeds the capabilities of known prototypes. Table 1 shows the results of comparative tensile tests of the proposed device and prototype; the tests were carried out in MISiS on the tensile testing machine R 5.

The test results show that the most vulnerable parts of the known design are the basket branches, the cable and the place of their connection. The tensile strength that can withstand the proposed device reaches 150 kg, which is 6.7 times greater than the forces withstood by the prototype (table 1). This advantage makes it easy to destroy the basket restrained by stone and remove it from the duct. The effort that allows you to achieve the proposed device is sufficient to destroy the calculus of any consistency.

The possibility of using a reinforced braid of various lengths and diameters allows you to hold a basket of any known type into it. The triptor can be used both with the endoscope and after its extraction.

Table 1 The results of comparative tensile tests of the proposed device and prototype No pp Test object Tensile strength, kg Prototype Olympus Proposed device one Fastening the branches of the basket with a sleeve at the distal end 45 2 Fastening the distal end of the cable in the manipulator 42 3 Cable 22 four Cable and basket connection 22 5 Jaws basket 23 6 Fixing the cable (11) in the clamp (10) 148

In case of infringement of the Dormia basket and calculus, the technique for using the device provides for the following sequence of manipulations. The proximal end of the restrained basket (11) is disconnected from the manipulator and inserted into the reinforced braid (2) of the tryptor (1). The proximal end of the braid is fixed in the channel of the front flange of the frame (4) of the tryptor (1). The cable (11) of the basket (12) is fixed by the clamp (10). A reinforced braid (2) is fed to the calculus along the restrained basket, its distal end (3) abuts the calculus. Using the flywheel (7), a traction force is created, directed along the cable (11) of the basket (12). Further 2 options are possible.

1. As a result of traction, the destruction of the calculus is achieved. Then the basket (12) can be freely removed from the duct. Fragments of the destroyed calculus remain in the common bile duct and can be destroyed by repeated manipulations.

2. As a result of traction, the destruction of one of the branches of the basket (12) is achieved. Then the destroyed basket is removed from the duct, and the calculus is destroyed by repeated manipulation with the help of another more powerful (power) basket. The reliability of the proposed design allows you to free the restrained tool with a calculus density exceeding the strength of the basket branch. It is important to note that when using the proposed device, only the jammed basket is subject to destruction, and the device can be freely removed and reused after appropriate processing. Moreover, the service life of the device is not limited.

The destruction of the calculus (or basket jaw) can be controlled both by radiography and traction, which can significantly reduce the radiation dose to both the doctor and the patient. In traction, the force that must be applied to extract the basket is estimated. The lack of resistance of the basket when trying to traction and patient complaints of pain suggests the successful completion of the manipulation.

The design of the device does not imply the use of its own basket for gripping, but uses the already restrained one, which allows it to be used as a conductor for a reinforced braid and at the same time part of a power tool, it is easy to mount and disassemble directly in the operating room.

Consumer properties of the object of the invention:

- the proposed method and device allows for intraductal destruction of any calculus both through the endoscope and in its absence;

- the proposed method and device allows for the destruction and extraction of a restrained instrument of any design both through the endoscope and in its absence;

- the proposed method and device can eliminate the transition to open surgery;

- the device is economical, can be used repeatedly; its service life is not limited;

- the introduction of the proposed device in clinical practice will improve the quality of minimally invasive interventions and reduce the risk of complications, disability and deaths;

- the introduction of the proposed device in clinical practice will increase the arsenal of endosurgical instruments.

The application of the method and device is illustrated by examples of operations performed at the Russian State Medical University (GOU VPO RSMU) of Roszdrav in a problematic research laboratory of endoscopy (Moscow).

Example 1

Patient Z., 83 years old, and / b 31211, was admitted to the surgical department on 23.11.08 on an urgent basis for acute pancreatitis, acute catarrhal calculous cholecystitis. Ultrasound: multiple small calculi in the area of the body and neck of the gallbladder, common bile duct expanded to 10 mm, in its distal section multiple small calculi. Biochemical analysis of blood from 11.24 .: bilirubin total. 99.7 mmol / L, ex 60.6 mmol / L, 39.1 mmol / L; amylase 303 units / l, AcAT 173 units, AlAT 161 units general blood test L-11.7 × 10 ⁹ / l, ESR - 12 mm / h.

11/28. performed ERPC, EPST, lithoextraction. In the study: choledoch with a diameter of up to 16 mm, in the lumen of the calculus with a diameter of 3-5 mm.

Ultrasound control from 02.12 .: choledoch expanded to 10 mm, in its distal section there are multiple small stones.

12/4. performed ERPC: choledoch with a diameter of up to 20 mm, in the lumen of the calculus with a diameter of up to 10 mm. Attempts to capture and remove stones using a reinforced basket are unsuccessful. The tool was replaced with a Dormia basket, during the audit 2 stones were captured. Attempts have been made to lower them into the duodenum 12, unsuccessful due to the mismatch in the size of the anastomosis-calculus. Release K. Dormia also failed. The basket cable is crossed, a device of its own design is attached to it, the stones are destroyed, the basket is undone. In the future, another ERCP was performed, the remaining calculi from the common bile duct were evacuated.

Ultrasound control from 10.12 .: choledoch with a diameter of up to 8 mm, calculi in the lumen are not visualized. Normalization of indicators of the general and biochemical analysis of blood is noted.

12.12. in satisfactory condition, the patient was discharged for outpatient treatment at the place of residence.

Example 2

Patient K., 71, and / b 27229, was admitted to the surgical department 16.10.2008 with a diagnosis of cholelithiasis, obstructive jaundice, choledocholithiasis.

Ultrasound from 11/17 .: choledoch up to 14 mm in diameter, the presence of a calculus up to 12 mm cannot be ruled out.

Biochemical analysis of blood from 11/17 .: bilirubin commonly. 252.4 mmol / L, ex. 152.2 mmol / L., 100.2 mmol / L; amylase 46 units / l, AsAT 140 units, AlAT 71 units, general blood test L-20.0 × 10 ⁹ / l, ESR - 12 mm / h. Biochemical analysis of blood from 11/20 .: bilirubin total. 339.21 mmol / L, ex. 313.1 mmol / L.

Ultrasound from 20.11 .: choledoch up to 22 mm in diameter, the presence of a calculus in it up to 12 mm cannot be ruled out.

11/20. performed ERPC: choledoch with a diameter of 10 to 16 mm, in the lumen of 2 rounded calculi with a diameter of 12-13 mm each. After papillosphincterotomy, a lithotripter was introduced into the lumen of the common bile duct, both stones were captured in a basket, however, during the lithotripsy attempt, the distal end of the lithotripter in the handle was destroyed. Attempts to lower the basket into the duodenum 12 are unsuccessful due to the mismatch of the size of the anastomosis-calculus. The cable of the lithotripter basket is crossed, a device of its own design is attached to it, the calculi are destroyed, the basket is unbroken.

Ultrasound control from 11/27 .: choledoch up to 6 mm in diameter, does not contain calculi.

12.11. in satisfactory condition, the patient was discharged for outpatient treatment at the place of residence

Example 3

Patient S., 71, and / b 29207, was admitted to the surgical department on 10.12.2007 with a diagnosis of cholelithiasis, obstructive jaundice, choledocholithiasis.

Ultrasound: multiple calculi in the gall bladder, the common bile duct is expanded to 11-12 mm.

Biochemical analysis of blood from 10.12 .: bilirubin total. 97.2 mmol / l, ex 66.6 mmol / l., General blood test L-13.1 × 10 ⁹ / l, ESR - 40 mm / h.

12.12. performed ERPC, instrumental revision, lithotripsy, lithoextraction. In the study: choledoch with a diameter of up to 15 mm, calculi were detected with a diameter of up to 4 mm in the terminal section, in the lower third, a calculus was up to 1 cm in diameter. Attempts to capture the calculus (1 cm) by lithotripter were unsuccessful. An audit of the biliary tract was carried out with a Dormia basket, during which the stone was captured, but attempts to extract, destroy it or empty the basket failed. The handle of the Dormia basket is destroyed, a device of its own design is attached to its distal end, the calculus is destroyed, the basket is released.

12/17. performed ERPC, instrumental revision of the bile ducts: a calculus with a diameter of up to 8 mm was detected in n / a choledoch, taking into account the immobility and small size of the stone, as well as the high likelihood of a relapse of choledocholithiasis in case of success of the X-ray endoscopic intervention, it is advisable to consider the possibility of using radical surgery.

12.12. performed cholecystectomy, choledocholithotomy, lithoextraction, drainage of the common bile duct according to Halstead, drainage of the abdominal cavity according to Spasokukotsky.

Sutures were removed on the 9th day. In satisfactory condition, was discharged under the supervision of a surgeon at the place of residence 04.01.2008.

Example 4

Patient Sh., 59 years old, and / b 4737, was admitted to the surgical department on 02.22.07 with a diagnosis of cholelithiasis, choledocholithiasis.

Ultrasound: multiple calculi in the gall bladder, common bile duct enlarged to 9 mm, the presence of calculus in the distal section cannot be ruled out.

Biochemical analysis of blood from 10.12 .: bilirubin total. 108.3 mmol / L, sp. 48.6 mmol / L, non-59.7 mmol / L, AcAT 133 units, AlAT 253 units, general blood test L-6.4 × 10 ⁹ / l, ESR - 26 mm / h.

02/26. performed ERPC, EPST: choledochus with a diameter of 10 mm in the projection of the common hepatic duct to 2.5 mm in the terminal section. In the middle third, calculus with a diameter of up to 10 mm with a perifocal extension of the common bile duct up to 12 mm. After papillosphincterotomy, a lithotripter was introduced into the lumen of the common bile duct, the stone was trapped in the basket, but with maximum compression, it broke in the handle. Attempts to lower the basket into the duodenum 12 are unsuccessful due to the mismatch of the size of the anastomosis-calculus. The cable of the lithotripter basket is crossed, a device of its own design is attached to it, the basket is released, the calculus is dropped in the bile duct. 02/28. repeated ERPC was performed: the diameter of the common bile duct from 5 to 9 mm, its expansion is local in nature and follows the contours of the calculus. Numerous attempts to capture and extract the calculus have been unsuccessful.

03.03. performed cholecystectomy, choledocholithotomy, lithoextraction, drainage of the common bile duct according to Halstead, rehabilitation, drainage of the abdominal cavity.

Sutures were removed on the 10th day. In satisfactory condition, she was discharged under the supervision of a surgeon at the place of residence on March 13, 2007.

Example 5

Patient S., 71 g, and b / w 22332, was admitted to the surgical department 24.09.2007 with a diagnosis of cholelithiasis, obstructive jaundice choledocholithiasis.

Ultrasound: multiple calculi up to 9-10 mm in the gallbladder, common bile duct enlarged to 12 mm.

Biochemical analysis of blood from 09.24 .: bilirubin total. 245.1 mmol / L, sp. 193.2 mmol / L, general blood test L-9.9 × 10 ⁹ / L, ESR - 12 mm / h.

27. September 28, attempts were made to X-ray endoscopic resolution of choledocholithiasis, to no avail.

10/2. when performing ERPC, the Dormia basket with two stones was infringed. The handle of the Dormia basket is destroyed, a device of its own design is attached to its distal end, the calculus is destroyed, the basket is removed.

04.10., 08.10. repeated ERCPs were performed, bile ducts were relieved of calculi.

10/15. in satisfactory condition, the patient was discharged for outpatient treatment at the place of residence.

Claims (7)

1. A method of in-duct fracture of stones with a Dormia basket and / or lithotrip trapped in a stone, characterized in that in-duct unlocking and extraction of a Dormia basket and / or a lithotrip trapped by a stone are carried out, for which a restrained basket is used as a conductor for access to the choledoch lumen, the proximal end of which is disconnected from the manipulator, lead into the reinforced braid of the tryptor and fixed in it; along the restrained basket, the reinforced braid of the tryptor is brought to the calculus to the stop; in the tryptor, a traction force of up to 150 kg is created, sufficient to destroy the restrained basket and (or) calculus. 2. Device for intra-ductal destruction of stones, containing a manipulator and a working part, characterized in that it further comprises a triptor, including a fixed frame, a flywheel, a screw, a movable flange and a clamp. 3. The device according to claim 2, characterized in that it allows you to provide forces up to 150 kg, unattainable when using other devices. 4. The device according to PP.2 and 3, characterized in that it is easily mounted and disassembled with the replacement of components during manipulations, depending on the situation. 5. The device according to PP.2 and 3, characterized in that it can be combined with all known types of baskets. 6. The device according to PP.2 and 3, characterized in that it involves repeated use without additional consumables and materials. 7. The device according to PP.2 and 3, characterized in that the period of its operation is unlimited.

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