RU2350285C1 - Device for formation of valval areflux small-large intestine anastomosis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns surgery, and can be used for formation of smal-large intestine anastomoses. The device for formation of valval areflux smal-large intestine anastomoses is executed from titan nickeline and consists of the two details. The wire detail has three coils of the oval form. One of coils is unbent under an angle 40-50°. The lamellar porous detail of the T-shaped form has in the central part a prominence with top in the form of an arch. Two extremities of the basis of a plate are unbent in opposite sides under an angle 90° to the central part.

EFFECT: application of the device which allows to dilate functionality of an anastomosis, to reduce number of postoperative complications, to reduce duration stationary and an out-patient treatment, to cut financial expenses on treatment of patients.

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Description

The invention relates to medicine, namely to surgery, and can be used to form small intestinal anastomoses.

The creation of anastomoses between the small and large intestine is mainly reconstructive. This type of anastomosis is indicated after resection of the small and large intestines with a bauginium damper.

Classically, the formation of an anastomosis is carried out using manual stitching of 2 intestinal loops. In order to improve functional results, areflux anastomoses are developed.

The most famous colonic anastomoses were developed by prof. Ya.D. Vitebsky (1991), A.I. Korabelnikov et al. (1999) [Vitebsky Y.D. Fundamentals of valvular gastroenterology. - Chelyabinsk: South Ural Book Publishing House, 1991. - p. 304; Korabelnikov A.I., Zamakhova E.G. Antireflux thin-colonic anastomosis. // Actual problems of coloproctology: mat. IV All-Russian. conf. - Irkutsk, 1999. - p. 40-40-40]. To prevent the entry of the large intestine chyme into the small intestine, they used invagination of the end of the small intestine into the large intestine.

Despite the advantages of the formation of areflux small intestinal anastomoses, the disadvantages are associated with manual suturing, wide opening of the lumen of the hollow organs, the risk of insolvency of the anastomosis, atrophy and sclerosis of the small intestine flap, and the possibility of reflux with isoperistaltic waves of the colon.

Creating a reliable functional anastomosis requires new technical means.

A device for creating an anastomosis "side by side", proposed by G.Ts. Dambaev et al., Selected by us as a prototype [Patent No. 2118511 from 09/10/1998. Device for creating an anastomosis "side to side". Authors: Dambaev G.Ts., Proskurin A.V., Dambaeva E.G., Soloviev M.M., Gunter V.E., Kropochev S.V.]. It contains two elongated spiral-wound turns of nickel-titanium wire with a "memory" shape effect, installed with the possibility of interaction between generators, the closed ends of which are bent from their plane in opposite directions at an angle of 10-20 °. The free ends are extended to the start of bends. During the operation, punctures are made in the adjacent walls of the connected organs, into which a pre-cooled device with V-shaped diluted turns is inserted. When heated, the device returns to its original form, compressing and forming an anastomosis. In the area of the bent turns, the tissue does not squeeze and a leg of the intestinal flap is formed, which is squeezed into the lower organ and serves as a shut-off valve for the reverse movement of the contents. This device is used to create anastomosis between the esophagus and the stomach, between the esophagus and the small intestine, having different wall thicknesses, and is not used in colorectal surgery. Formed intestinal flap in the future can undergo atrophy, does not provide absolute barrier action and portioned flow of the contents of the small intestine into the colon.

The objective of the present invention is to expand the functionality of ileocoloanastomosis by creating an areflux valve with an elastic intestinal flap in the lumen of the intestinal anastomosis.

The technical result of the proposed device is that a device made of titanium nickelide, consisting of wire and plate parts, provides the formation of an intestinal flap from the walls of the small and large intestines, which performs the function of an elastic flap valve in the intestinal lumen.

The technical result is achieved in that the device from titanium nickelide consists of two parts: the wire part has 3 oval turns, one of which is bent at an angle of 40-50 °, and the porous plate part has a T-shape, the top of which is made in an arc shape, and the two ends of the base of the plate are bent in opposite directions at an angle of 90 ° to the central part of the plate.

The problem is solved due to the fact that the turn of the wire part, bent at an angle of 40-50 °, provides blood supply to the anastomosed sections of the intestine, which is necessary for the formation of an elastic flap valve formed by the walls of the small and large intestine, and one of the non-bent turns is inserted during surgery the lumen of the colon, which subsequently determines the direction of rejection of the structure and its smooth migration due to the preserved oval shape of the device.

The lamellar porous part is a framework for forming an elastic flap valve in the intestinal lumen. The central part of the porous plate is inserted between the serous surfaces of the anastomosed sections of the intestine transverse to the length of the small intestine, and the two ends of the base of the plate bent at an angle of 90 ° remain on the surface of the serous membranes of the small and large intestines and serve to fix the part. Subsequently, due to the porous structure of the plate, surrounding tissues grow into it [Kecherukov A.I., Aliev F.Sh., Chernov I.A., Gunther V.E. New technology for the formation of colonic valvular anastomosis. // Shape memory biomaterials and implants: mat. int. conf. - Tomsk, 2001. - p.233]. The T-shape of the porous implant ensures its transverse location in the plane of the anastomosis, which ensures constant covering of the lumen of the anastomosis with a flap-flap (valve), and not squeezing it into the downstream department. Valve operation is independent of iso- and anti-peristaltic waves. At high pressure and, consequently, the stretched walls of the colon, the flap-flap provides a barrier effect, maintains the constancy of the bacterial environment in various sections of the digestive tract. After the transit of the contents of the intestine, the implant is straightened due to the base. With a decrease in pressure in the intestine proximal to the anastomosis, the plane of the base due to the rectification of the intestinal wall returns to its original state. The damper valve significantly blocks the intestinal lumen, which is the prevention of chyme reflux into the small intestine. The operation of the valve can be described as the principle of “Vanka-Vstanki”. The functional usefulness of this valve is largely determined by the superelasticity of nickel-titanium alloys corresponding to the elastic properties of biological tissues.

The transverse introduction of a lamellar porous part from the side of the mesenteric edges of the intestines ensures the maximum preservation of blood supply in the formed intestinal flap, since its base faces the mesenteric edge and laterally long and short straight vessels extending from it. In this case, the continuity of the circular muscle layer is minimally damaged and, accordingly, the violation of evacuation function in the anastomosis zone is prevented.

The invention is illustrated by drawings. Figure 1 shows the wire part of the device having 3 turns of an oval shape (1), one of which is bent at an angle of 40-50 ° (2). Figure 2 presents the lamellar porous part of the device of a T-shaped. The central part (3) of the plate-like porous part has a protrusion (4), the apex of which is made in the form of an arc, and the two ends of the base of the plate (5) are bent in opposite directions at an angle of 90 ° with respect to the central part. Figure 3 shows the connected sections of the small (6) and large intestine (7), isoperistaltically brought together by the side walls. The pre-cooled wire part of the device (8) with diluted turns is inserted transversely into the intestinal tube through punctures in the anti-mesenteric edges of the contacting walls of the intestines. An unbent turn of the wire part of the device is introduced into the lumen of the colon. Figure 4 shows the introduction between the serous surfaces of the thin (9) and colon (10) lamellar porous parts of the device (11).

The proposed device is used as follows:

The connected sections of the small and large intestines are isoperistaltically approaching the side walls. Punctures are made in the anti-mesenteric edges of the contacting walls of the intestines, through which a pre-cooled wire part of the device with V-shaped turns transversely to the intestinal tube is inserted into the intestinal lumen. For smooth migration, an unbent turn of the device should be located in the lumen of the colon. Under the influence of tissue temperature, the wire part of the device acquires its original shape, performing metered compression along the perimeter of the interaction of the turns. In the area of the bent turn, the tissues are not subjected to compression and are not rejected, forming an intestinal flap from the walls of the small and large intestines.

After suturing the incisions of the intestinal wall in this area from the mesenteric edge of the connected intestine sections, the lamellar porous part of the device using ordinary tweezers or a clamp so that the central part of the porous plate is transverse to the length of the small intestine between the serous surfaces of the hollow organs pinched in the window, and bent under the straight at an angle the ends of the base of the plate are on the surface of the serous membranes of the small and large intestine. After implantation, the lamellar porous part of the device over the base is fixed with separate manual sutures.

Examples of practical use of the device.

1. Patient K-ko A.I., 62 years old, medical history No. 3458, was admitted September 15, 2006 as planned to one of the clinics in Tyumen with a diagnosis of “End ileostomy”. A history of 6 months ago resection of the ileum, ileostomy due to blunt trauma to the abdomen, rupture of the ileum. 09/17/2006 a laparotomy was performed, the formation of a valve small-colonic anastomosis side to side using a combination of wire and porous titanium nickelide implants. The proposed device was used as follows: Loops of the small and large intestines are isoperistaltically fixed side to side. Through punctures, diluted branches of a pre-cooled wire part of a titanium nickelide device measuring 18 × 7 mm were introduced into each loop. An unbent turn is introduced into the lumen of the colon, a turn bent at an angle of 50 ° into the lumen of the small intestine. After the shape of the wire part of the device returns, the sections of the intestinal wall are sutured. From the side of the mesenteric edge of the connected sections of the intestine, a lamellar porous part of a T-shaped device was implanted, having a thickness of 0.2 mm, porosity of 85%, pore sizes of 10-500 μm. The central part of the lamellar porous part in shape corresponds to the “window” of the wire part and has dimensions of 15 × 6 mm. In the central part of the plate-like porous part there is a protrusion made in the form of an arc with a diameter of 2 mm. The length of each of the ends of the base of the plate bent at right angles is 3 mm, the total length of the base is 6 mm. The central part of the lamellar porous part of the device is embedded between the serous surfaces of the small and large intestine. The ends of the plate base bent at right angles are located on the surface of the serous membranes of the small and large intestine. After implantation, the lamellar porous part of the device over the base is fixed with separate manual sutures. The ileostomy is closed after 2 weeks extraperitoneally. The compression device was rejected on the 11th day and migrated from the gastrointestinal tract naturally. Complications of the early and late postoperative period were not observed. Bowel dysfunction, bloating, and stool disorders were not noted. Dysbacteriosis is not detected. On irrigography, after 6 months, barium is not thrown into the small intestine. Duration of observation is 8 months. There are no complaints.

2. Patient B-in K.N., 76 years old, medical history No. 538, was admitted 01.24.2007 on an emergency basis with a diagnosis of “Cr. transverse colon. Acute colonic obstruction. " February 24, 2007, a laparotomy, right-sided hemicolectomy, excretion of terminal ileostomy, formation of a valve small-colonic anastomosis side to side were performed. The proposed device is used as follows: The proposed device is used as follows: The loops of the small and large intestines are isoperistaltically fixed side to side. Through punctures, diluted branches of a pre-cooled wire part of a titanium nickelide device measuring 15 × 6 mm were introduced into each loop. An unbent turn is introduced into the lumen of the colon, a turn bent at an angle of 50 ° into the lumen of the small intestine. After the shape of the wire part of the device returns, the sections of the intestinal wall are sutured. From the side of the mesenteric edge of the connected sections of the intestine, a lamellar porous part of a T-shaped device was implanted, having a thickness of 0.2 mm, porosity of 85%, pore sizes of 10-500 μm. The central part of the lamellar porous part in shape corresponds to the “window” of the wire part and has dimensions 13x4 mm. In the central part of the plate-like porous part there is a protrusion made in the form of an arc with a diameter of 2 mm. The length of each of the ends of the base of the plate bent at right angles is 3 mm, the total length of the base is 6 mm. The central part of the lamellar porous part of the device is embedded between the serous surfaces of the small and large intestine. The ends of the plate base bent at right angles are located on the surface of the serous membranes of the small and large intestine. After implantation, the lamellar porous part of the device over the base is fixed with separate manual sutures. The ileostomy is closed after 2 weeks extraperitoneally. The ileostomy is closed after 2 weeks extraperitoneally. The compression device was rejected on the 10th day and migrated from the gastrointestinal tract naturally. Complications of the early and late postoperative period were not observed. Bowel dysfunction, bloating, and stool disorders were not noted. Dysbacteriosis is not detected. On irrigography, after 6 months, barium is not thrown into the small intestine. Duration of observation is 6 months. There are no complaints.

The proposed device has significant advantages compared with the prototype. In the prototype, the angle of the bend of the coil is 10-20 ° from the plane of the generatrix of the device, and the ends of the turns are bent from their plane in opposite directions. Due to this, the gap to ensure adequate blood circulation and the true angle between the turns becomes 2 times larger, which was calculated by the prototype authors to connect the walls of the esophagus and stomach or esophagus and jejunum. In the proposed device, only one of its turns is bent from the plane of the wire part, the angle is 40-50 °, which allows using the design to create ileocolanastomoses and to ensure blood supply to the intestinal flap-valve formed by the walls of the small and large intestines. An unbent turn of the wire part is inserted during the operation into the lumen of the colon, which subsequently determines the direction of migration of the structure into the lumen of the colon.

In contrast to the prototype, a porous plate of titanium nickelide having a T-shape is used to form the damper valve. After implantation, the central part of the lamellar porous part of the device is located between the serous surfaces of the small and large intestine, and the ends of the base bent in opposite directions on the surface of the serous membranes or subserous. The T-shaped plate-like porous part provides the formation of an elastic valve-damper located in the plane of the large intestine wall and not shifted in the absence of chyme in the oral or aboral sections of the intestine. With a decrease in pressure in the colon and the presence of a chyme in the small intestine, the flap valve opens, after the transit of the contents of the intestine, it returns to its original position due to the longitudinally located base of the porous plate and prevents reflux of the large intestine contents into the small intestine. The flat base of the lamellar porous part of the device located longitudinally connected to the walls of the intestine, sprouting connective tissue in the form of a single composite, provides a constant return of the flap to its original state, overlapping the gut lumen.

The examples given illustrate the possibility of using this device for the formation of a valve areflux thin-colonic anastomosis. The device was used on the basis of the surgical departments of the Tyumen Regional Clinical Hospital. Department Hospital Art. Tyumen. 35 operations completed.

The device selected as a prototype is used only for the formation of anastomoses between the stomach and esophagus, esophagus and jejunum. Therefore, this device for the formation of valvular areflux thin-colonic anastomosis is not used. In this regard, a comparative analysis was carried out with manual methods for creating small bowel anastomoses.

The use of the developed device allowed to reduce the duration of the operation compared to manual methods. The average time of formation of the valve areflux thin-colonic anastomosis was 12.33 ± 0.5 minutes, manual - 20.15 ± 0.77 minutes (t = 35.4; p≤0.001). The incidence of postoperative complications was 8.57 ± 4.7% and 13.63 ± 7.3%, respectively. Complications directly related to the use of the developed device were not observed.

A comparative analysis of long-term complications showed that when using the proposed device, the frequency of reflux ileitis was 2 times lower (16.67 ± 7.6%) than with the manual formation of anastomoses (35.7 ± 12.8%) (p <0.005 )

The use of the proposed device made it possible to reduce the duration of the postoperative hospital bed by 1.5 times (by 6 days) by reducing the frequency of immediate postoperative complications (t = -3.05; p <0.05). The average period of patient disability with the proposed device was 28.97 ± 1.83 days, which was significantly less than with the manual formation of anastomoses (40.02 ± 1.59 days) (t = -4.14; p <0.001) . Due to the reduction in the postoperative bed day and the outpatient treatment phase, the financial expenses for the 1st patient decreased by 6507.25 rubles.

Claims (1)

A device for forming a valve areflux thin-colonic anastomosis, containing a titanium nickelide wire part having three oval turns, characterized in that it further comprises a T-shaped plate porous part made in the form of a frame for forming an elastic valve-shutter in the intestinal lumen while one of the turns of the wire part is bent at an angle of 40-50 °, and the two ends of the base of the plate-like porous part are bent in opposite directions at an angle of 90 ° to the central part STI having a protrusion with a vertex in an arc shape.

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