RU2275870C2 - Clip for creating choledochoduodenal anastomosis - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device has two adjacent and parallel linear branches. The branches are joined by means of compressing engagement mechanism designed as C-shaped cross-piece, ends of which are connected to and smoothly mated with the branches at their beginning. Branches differ in length by 20-30%. Free ends of the branches are length difference far from each other.

EFFECT: enhanced effectiveness of treatment; improved operation consistency characteristics.

3 cl, 4 dwg

Description

The invention relates to medical equipment.

Violation of patency of extrahepatic bile ducts of various etiologies (for example, cholelithiasis) is one of the most acute problems of abdominal surgery. The technical complexity of surgery is aggravated by the presence of an aggressive environment - bile. The degree of complexity predetermined the separate qualification of such operations with the term “biliodigestive”. In turn, in this class, the operations of anastomosis of the bile ducts are identified as the most risky and requiring the highest qualification of the surgeon. One of such operations is an anastomosis of the common bile duct (choledochus) and duodenum (choledochoduodenoanastomosis). Increasing the viability of anastomotic sutures is a long-standing problem, solved by medical science and clinical practice with the success in achieving success.

Suture materials are known (silk, kapron, chrome catgut) for the “manual” formation of anastomoses, suggesting the application of airtight, i.e. frequent seams. This technical tool, as well as the methods of operations it defines, has many disadvantages:

- increased injuries of stitched fabrics due to the roughness of the threads,

- increased inconsistency of the joints due to the fit of the suture material, including for bacterial microflora,

- necrotizing the edges of the anastomosis due to inadequate tension of the threads, purulent and chronic inflammation in places of necrosis and subsequent cicatricial deformation of the anastomosis.

Even a precision, perfectly smooth and reactive suture with the use of expensive microsurgical equipment and monofilament filaments from polyoleofin compounds [Lapkin K.V., Malyarchuk V.I. and others. Precision suture with a thread of polyoleofin compounds ... // Surgery. 1987, No. 1, pp. 46-52] gives up to 9% insolvency in the form of bile leakage.

The improvement of biliodigestive anastomoses has passed the stages of using biological glue [Vinogradov V.V., Ostroverkhov G.E. and other Cyanocrylate glue in surgery of the biliary tract // Surgery. 1969, No. 8, pp. 72-82], staplers with tantalum staples [A.S. No. 1142114 A 61 B 17/11 Surgical stapler] and, finally, the stage of compression technology. Each of them has significant drawbacks, such as tightness problems during thinning, hypertrophy or swelling of the walls of anastomosed organs, bleeding, inflammatory tissue reaction, cicatricial narrowing, etc. The method and the corresponding compression anastomosis technique have the least damage. Connecting and compressing agents (for example, Murphy’s button, magnetic rings, etc.) make it possible to form a sealed anastomosis with healing according to the type of primary tension, with minimal inflammatory reaction and the development of scar tissue.

The most advanced device for anastomosis of hollow organs, including the bile ducts, are varieties of clips made of an alloy based on titanium nickelide with effects of shape memory and superelasticity. The closest analogue used, including for choledochoduodenal anastomosis, is selected as a prototype of the invention [B.K. Gibert. Development and application of shape memory implants in biliodigestive surgery. Doct. Thesis. Tyumen GMI. 1995, p. 78].

The clip (figure 1) is made in the form of a closed double-turn spiral ellipsoid shape of nickel-titanium wire. The turns 1 serve as jaws driven by a compressive action due to the strain strain of the wire section 2 connecting them. To form an anastomosis of hollow organs of the side-by-side type, in the contacting walls, punctures are made according to the size of the jaw diameter, injected into them jaws that are open in a cooled state, which, when heated, close and compress the tissue of the walls. Tissues impaired along a narrow line of closure and compression are deprived of blood supply (ischemia and necrosis), and in adjacent layers they grow together, forming a continuous, tender (with a minimum of scarring), hermetic suture. The tissue site separated along the line of necrosis is excreted together with the device that performed its function along the contents of the anastomosed vessels.

The successful practice of the past decades has proved the overwhelming advantage of compression anastomosis and the obvious promise of service devices made of shape memory alloys (now and specifically titanium nickelide).

The prototype device has disadvantages.

1. The coil design of the clip determines its impressive size relative to the size of the operated bile ducts. The wall sections performed for him increase the injury and increase the possibility of infection of the abdominal cavity during the operation.

2. When the clip is rejected, the direction of its initial migration is ambiguous and depends on various factors - the difference in the pressure of the contents, the motility of the vessels connected, etc. Thus, there is the possibility of retrograde migration of the torn clip, as a threat to the insolvency of the operation.

The technical result of the invention is to increase the viability of the operation by reducing trauma and preventing retrograde migration of the torn device.

The specified technical result is achieved in that in the clip for choledochoduodenal anastomosis, made of an alloy based on titanium nickelide with a shape memory effect and containing two parallel and adjacent jaws associated with the mechanism of their compression interaction, the mechanism of compression interaction is made in the form of a C-shaped jumper connected smoothly with the beginnings of the branches, and the lengths of the branches vary by 20-30%, and their free ends are located at a distance of the difference in lengths.

Preferably, a flattened cross section of a separate jaw with a ratio of large and small cross-sectional dimensions is 2-3 times. In this case, the branches are oriented by a large size in the plane of the device.

Preferably, the jaws and the mechanism of their compression interaction are made from a single piece of wire, and each jaw is folded in two and bent at the free end of the jaw.

The attainability of the technical result is due to the complex manifestation of the properties of essential features.

Linear, i.e. a multiple smaller in diameter than that of the prototype, the shape of the jaws (figure 2) allows for its installation in the walls of the anastomosed vessels to perform the smallest holes — punctures, not cuts. This reduces trauma with all the inherent negative consequences and the possibility of infection of the abdominal cavity during surgery. The C-shaped jumper form, which is functionally present for the compressive interaction of the branches, is rationally compact, simple and efficiently aggregated with the latter. A compressive force is generated along its entire length and is summed at the ends. The source of the force is the stress of thermodynamic deformation, which for the material used - an alloy based on titanium nickelide - maximally meets the requirements for correct tissue compression.

The linear form of the anastomosis obtained after necrotization of the restrained tissues and rejection of the device (in contrast to the site form for the prototype) does not constitute a noticeable obstacle to the restored bile transport. However, the absence of a gaping hole to some extent prevents the reflux of the contents of the duodenum into the lumen of the common bile duct. Thus, the formed anastomosis has signs of valvular, which increases the functional viability of the reconstructed organs.

The installation of the clip in the performed punctures is carried out sequentially, starting with the introduction of an elongated jaw into the distal opening (lower along the bile) and ending with the introduction of a smaller jaw into the proximal opening (Fig. 3). Thus, the surgeon's actions are distributed in time and simplified structurally, creating convenience and increasing the correctness of the installation.

After rejection, the clip is in a state of unstable equilibrium and equiprobable migration to the common bile duct or duodenum. The elongated jaw located in the duodenum (Fig. 3) due to the increased retention along the intestinal wall and greater hydrodynamic resistance sets the direction of the clip bias in the duodenum, i.e. to its excretion in a natural way. Thus, the possibility of retrograde migration and insolvency of the operation is eliminated.

The flattened cross-sectional shape of the jaws (FIG. 3) gives rigidity in the compression direction and prevents the prolated tissue from closing over the jaw.

The implementation of the device from a single piece of wire simplifies and reduces the cost of the technology for the production of clips, which includes obtaining material, manufacturing a workpiece and the device itself.

The accompanying technical result is a reduction in comparison with the prototype of the overall dimensions of the device, which is important for the use of clips in laparoscopic surgery technology and as a factor in minimizing interference from a foreign object of the body.

The drawings show:

Figure 1. Spiral-shaped clip for choledochoduodenal anastomosis (prototype). 1 - branches, 2 - connecting section.

Figure 2. Linear clip for choledochoduodenal anastomosis, made of a single piece of wire. 1 - branches, 2 - C-shaped jumper.

Figure 3. Cross sections of branches (options).

Figure 4. Clips installation diagram. 1 - long branch, 2 - short branch, 3 - C-shaped jumper, 4 - common bile duct, 5 - duodenum.

The attainability of the technical result is confirmed by specific examples of the clinical use of the clip in the city hospital of emergency medical care of the city of Shadrinsk, Kurgan region.

Example 1

Patient L., 64 years old. Diagnosis of the disease: gallstone disease, choledocholithiasis, stenosis of the terminal portion of the common bile duct, chronic pancreatitis, type 2 diabetes mellitus, 2nd degree. 5 years ago, the gallbladder was removed.

For medical reasons, an operation was performed - choledochoduodenal anastomosis - using clips as the technical means according to the formula of the invention.

The clip has the characteristics: jaws 1 with a length of 20 and 12 mm are made of doubled nickel-titanium wire (Fig. 3, pos. 3) of the TN-10 grade with a diameter of 1.5 mm (Fig. 2). The outer diameter of the C-shaped jumper is 2-5.5 mm.

In the course of the operation, the clip works as follows: the choledoch is mobilized by the upper middle transperitoneal access and dissected in the longitudinal direction at a length of 10 mm in the area of stone localization. The wound of the common bile duct is sutured tightly. Holes with a diameter of about 2 mm are formed in the adjacent wall of the common bile duct and the anti-mesenteric wall of the duodenum with an electrocoagulator. The holes are brought together by a single catgut seam.

The branches of the chilled under chloroethyl clips are placed in a V-shape and introduced by the sequential beginning of the introduction of the duodenum (long jaw) and choledochus (short jaw) into Fig. 4. When heated to the body temperature of the sick jaw, returning to its original position, infringed on the walls of the anastomosed vessels. The wounds of the common bile duct and duodenum are sutured with two sutures. To ensure the primary patency of bile before the opening of the newly created anastomosis, the common bile duct is drained according to Vishnevsky. The abdominal cavity is drained.

In the postoperative period, healing proceeded by primary intention. These drains were removed on the 16th and 6th day, respectively. The clip was torn off and departed naturally on the 20th day. The formed linear anastomosis functions well, with no signs of inflammation or failure. There is no pain and jaundice.

Example 2

Patient K., 63 years old. He entered the surgical department on an emergency basis with a diagnosis of gallstone disease, acute calculous cholecystitis, choledocholithiasis, stenosis of the large duodenal papilla, obstructive jaundice.

After stopping the attack and examining the patient with upper middle transperitoneal access, a complex of surgical interventions was performed: cholecystectomy from the neck, transverse choledocholithotomy, supraduodenal choledochoduodenal anastomosis using the proposed clip and the procedure for performing the operation of Example 1.

Postoperative healing occurred by primary intention. Drainages from the abdominal cavity and common bile duct were removed on the 5th and 17th days. The clip was torn off and departed on the 21st day. Anastomosis is functioning normally. The patient's condition is good.

The design and technological development of the clip is sufficient for widespread use and compliance with the criterion of "industrial applicability".

Claims (3)

1. A clip for choledochoduodenal anastomosis, made of an alloy based on titanium nickelide with a shape memory effect, containing two linear jaws parallel and adjacent, connected by a compression interaction mechanism, characterized in that the jaw lengths vary by 20-30%, their free ends are located at a distance of the difference in lengths, and the mechanism of compressive interaction is made in the form of a C-shaped jumper connected by the ends and smoothly conjugated with the beginnings of the branches. 2. The clip according to claim 1, characterized in that the branches are flattened in cross section, with a aspect ratio of 2-3 and oriented with a large size in the plane of the device. 3. The clip according to claims 1 and 2, characterized in that the branches and the mechanism of compressive interaction are made of a single piece of wire, with each branch bent at the free end and folded in half.

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