RU2189185C2 - Device for creating hollow organ anastomosis - Google Patents

Abstract

FIELD: medical engineering. SUBSTANCE: device has two of the first titanium nickelide wire coils possessing shape memory properties. The coils are fitted coaxially to make the guides touch each other and cylindrical spiral manufactured form the same wire having at least two coils. The spiral is coaxially mounted in the lumen of the two first coils. Smooth conjugation is available between their internal ends and the spiral ends. Every first coil is shaped as an element of flat spiral which winding pitch being equal to spiral diameter and length being equal to 1.1-1.2 times the full spiral revolution. Ratio of external spiral radius to the minimum value of the first coils rounding internal radius is equal to 0.5-0.7. The first coils touch each other at segments the length of which is equal to 10-20% of full spiral revolution length. EFFECT: reduced risk of traumatic complications. 4 dwg

Description

 The invention relates to medicine, namely to surgical technique, and can be used to create compression anastomoses of hollow organs mainly in the abdominal region.

 Anastomoses of hollow organs are known when their fragments are end-to-end (butt-end anastomosis), overlap ("side to side"), as well as their combinations during the formation of anastomoses of hollow organs of various geometries (for example, intestines and stomach). In terms of technical means, anastomoses using manual seams with nylon thread, chrome catgut, tantalum brackets, etc. are known. The disadvantages of these methods and technical equipment cause the average insolvency of operations of 15% or more.

 Since the end of the last century, a compression anastomosis has been known [1] using a device called the Murphy Button, based on squeezing the walls of the connected organs along the periphery of the created hole until necrotic tissue infringement and subsequent rejection of the inner tissue site along with the device. Compared to manual seams, the resulting compression suture is characterized by high strength, the absence of a tendency to sequential stenosis, and the maximum similarity of the resulting hole to the natural lumen of the hollow organ.

 The subsequent history of the development of compression anastomosis is associated with the improvement of technical means in relation to their biocompatibility, simplification of the technique and increasing the viability of the operation. Noticeable and sharp progress was noted in connection with the use in medical technology of alloys with the effect of shape memory - mainly titanium nickelide.

 A device is known for compression anastomosis of the large intestine [2], containing two compression rings and means for their rapprochement and constriction in the form of a periodically deformed structure (zigzag, spiral, etc.) made of nickel-titanium wire with shape memory effect. The walls of the connected organs (mainly when they are "butt") are placed between the rings and squeezed by the action of the form-restoration force of the rendezvous means. After the walls grow together near the compression zone, necrotization and rejection of the internal area, the device leaves the body naturally.

 The disadvantage of this device is the relatively complex structure and the large dimensions that depend on it, as a result of which the device is limited in scope. As a rule, it is used for anastomosis of the large intestine.

 A device for compression anastomosis of hollow organs, mainly with the location of the connected fragments (eg, intestines) "side by side" [3]. By the greatest functional and technical similarity, it is selected as a prototype of the proposal.

 The prototype device contains two elongated (for example, ellipsoidal) turns of a nickelidotitanium wire with a shape memory effect arranged spirally, coaxially, with the possibility of interaction between the generators (Fig. 1).

During the operation, the connected walls of the hollow organs are brought together until the serous membranes come into contact. At a distance of 3-5 mm from the contact line in the connected walls, punctures are performed. A device with dimensions corresponding to the proposed anastomosis is cooled in the refrigerant, the turns are bred at an angle of 30-40 ^° relative to each other (Fig. 1 b), and they are introduced with the diluted ends separately into the prepared punctures. On the outer edges of the punctures for sealing impose serous-muscular-submucosal sutures. When heated to body temperature, the device takes its initial closed form, uniformly compressing the walls of the connected organs. To create the initial patency of the anastomosis, the clamped tissues are dissected in the lumen of the turns.

 Under the influence of constant prolonged compression, necrotization and rejection of the tissue of the walls under the wire of the coils occurs, their fusion near the compression on the outside of the coil. The rejected tissue of the walls of the organs together with the device leaves the body naturally.

 The advantage of the device is the high quality of the formed anastomosis. The disadvantage is increased injuries of the operation associated with suturing of punctures in the walls of organs.

 The technical result of the invention is to reduce the injury rate of the operation.

 The specified technical result is achieved by the fact that in the device for anastomosis of hollow organs containing two first turns of nickel-titanium wire with a shape memory effect, mounted coaxially with the possibility of interaction between the generators, each first turn is made in the form of a flat spiral element with a winding pitch equal to the diameter wire, with a length of 1.1-1.2 the length of the full revolution of the spiral, is additionally equipped with a cylindrical spiral of at least two turns of a similar wire mounted coaxially in the illumination of the first two turns and connected by the ends smoothly conjugate separately with their inner ends, and the ratio of the outer radius of the cylindrical spiral to the smallest inner radius of rounding of the first turns is 0.5-0.7.

 The technical result is easy to prove by describing the design and operation of the device. Figure 2 shows a device for anastomosis in the "cold" state. Two spiral-shaped turns 1 of nickel-titanium wire serve as compression elements, since they are installed in a row with the contact of their generators. The tissues of the walls of the anastomosed hollow organs, being placed between them, will be compressed, infringed until necrotic. The compressive force is reported by the cylindrical spiral 2, which is connected smoothly conjugate by sections 3 to the inner ends of the turns 1. The gap between the cylindrical spiral 2 and the turns 1, given by a ratio of radii of 0.5-0.7, serves to ensure the passage of tissues of the walls of the hollow organs when the device is installed. The value of the ratio is determined experimentally from the condition of convenience of the surgeon's manipulations. To install the device, the walls of the connected hollow organs (for example, small intestines) are brought together until the serous membranes come into contact. At a certain distance from the line of contact in the walls of the intestines, holes (punctures) are made opposite each other, capable of passing the wire used in the cross section of the device. Through the formed holes impose holders to fix the connected fragments and places of punctures.

 The device for the anastomosis is cooled under chloroethyl and the turns 1 are bred to a distance commensurate with the distance between the punctures (Fig. 3). The threads of the holders are passed into the lumen of the turns 1. The ends of the turns are introduced into the holes of the punctures. Having seized the edges of the holes with "mosquito" tweezers, the tissues are moved simultaneously along the entire perimeter of the turns 1. Thus, a separate turn is located inside the hollow organ. Holders and tweezers clean. The device under the action of body heat of the patient returns to its original form (figure 2), compressing the walls of both fragments forming the turns 1. For reliable sealing of organs in the puncture places, the turns 1 are in contact with the imposition of sections 10-20% of the length of the full revolution of the spiral (sections 4 in FIG. 1), since the step of winding the spiral is equal to the diameter of the wire.

 Further action of the device is performed according to the well-known algorithm: necrotization of restrained tissues, fusion of the walls of hollow organs from the outside of the compression zone, the device exits the body naturally.

 In contrast to the prototype device, the proposed one is installed without imposing serous-muscular sutures in the places of the formed openings, thereby achieving the claimed technical result.

 The number of turns of a cylindrical spiral is determined by the magnitude of the required compression force and the amplitude of the breeding rings during installation, that is, ultimately, the anatomy of the hollow organs. It has been experimentally determined that the minimum number of turns that is still possible in certain cases (for example, with anastomoses of thin hollow organs) is 2.

The illustrations show:
figure 1 - a device for anastomosis of hollow organs - prototype;
figure 2 - a device for anastomosis of hollow organs according to the claims in the "cold"state;
figure 3 - the proposed device prepared for installation;
4 is a working moment of installation of the device.

 Achievability of the technical result is confirmed by testing on experimental animals.

 Example: Outbred dogs used.

 Under general anesthesia, the pathology of the hollow organ is modeled - a small intestine is dissected. The resulting stumps are suppressed with purse-string sutures and positioned to create an anastomosis in the side-to-side position. A device was used for the anastomosis (Fig. 2) with the following characteristics: the radius of rounding of the turns of compression elements is 5-10 mm, the outer radius of the cylindrical spiral is 2.5 mm, the number of turns of the cylindrical spiral is 4, the wire diameter is 1.2 mm, the material of the wire is titanium nickelide grade Т- 10.

The operation is as follows:
The walls of the small intestine bring together to the contact of the serous membranes. On the mesenteric edge at a distance of 4-5 mm from the line of contact, punctures are performed in the connected walls.

 The device is cooled under chloroethyl and deformed in the axial direction, moving the compression coils 10-12 mm apart (Fig. 3). Using the thread-holders and tweezers "mosquito", the device is inserted with free ends into the formed puncture holes for the entire length of the turns.

 When the device is heated to the body temperature of the animal, the original shape is restored, the walls of the connected organs are compressed. In this case, the cylindrical spiral is located in the gap between the connected walls, and the lumen of the future anastomosis is absent. For the period of formation of the anastomosis - up to 12 days, the animal is fed through the superimposed stoma.

 Control examinations of animals withdrawn from the experiment after 1-90 days indicate a good condition of the anastomosis, the absence of a rough connective scar and signs of stenosis.

 Repeating tests on 5 animals with varying intestinal anastomosis sites (7 anastomoses) resulted in 100% viability of the operation.

Sources used in compiling the description
1. Stukkey L. G. Pugovka Murphy and its modifications. S. - Pb., 1903, p. 116.

 2. Monograph "Medical materials and implants with shape memory." Ed. Tomsk University, Tomsk, 1998, p. 305.

 3. USSR copyright certificate 1186199 (prototype).

Claims (1)

 A device for anastomosis of hollow organs, containing the first two turns of nickel-titanium wire with a shape memory effect, mounted coaxially with each other forming a contact, characterized in that it is additionally equipped with a cylindrical spiral of at least two turns of a similar wire, mounted coaxially in the lumen of the first two turns and the ends smoothly conjugated with their inner ends, and each first turn is made in the form of a flat spiral element with a winding pitch equal to the diameter of the wire, and has a length, composition which is 1.1-1.2 of the length of the full revolution of the spiral, the ratio of the outer radius of the cylindrical spiral to the smallest inner radius of curvature of the first turns is 0.5-0.7, while the first turns are made by touching sections with a length of 10-20% from the length of a full revolution of the spiral.

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