RU2199961C2 - Method for developing terminal compression large intestinal anastomosis - Google Patents

Abstract

FIELD: medicine, surgery. SUBSTANCE: the method deals with operations upon large intestine. One should dissect serous-muscular intestinal membranes being orally and aborally against pathological focus. Affected area should be removed. Deserosed intestinal ends should be centralized. One should introduce nickelide-titanium-made device in the form of three coils through stump's puncture. Compression power between coils corresponds to 600-800 g/sq. mm. Ligated stumps are pinched in the center of compression device. Lumen of anastomosis is restored by dissection of pinched tissues. Punctures should be sutured. The method enables to modify the quality of terminal anastomosis. EFFECT: higher efficiency of operation. 17 dwg, 1 ex

Description

 Over the past 20 years, the incidence of colon diseases has more than doubled, and the number of planned and emergency surgical interventions has accordingly increased. Despite the successes achieved, complications after operations on the colon still account for 10-15% (Belyaeva O.A. et al., 1995; Eramashintsev A.K. et al., 1995; Kanshin N.N. et al., 1995). In this case, the fate of the patient is largely determined by the quality of the surgical suture.

 To date, the number of methods and modifications of the manual intestinal suture is approaching 500, and the number of suture material exceeds 100. Nevertheless, neither single-row, nor multi-row sutures, nor closed and open methods for applying anastomoses, nor the use of absorbable suture material does not relieve the patient from suture failure. . The main disadvantages of a manual suture are: the wick properties of the threads, the severity of the inflammatory reaction in the anastomosis, healing by secondary intention with the development of cicatricial stenosis. (Shekhter A.B. et al., 1984; Kalnberz V.K. et al., 1988). Currently, the possibilities of manual seam are almost exhausted.

 The use of staplers contributed to a significant improvement in the results of operations on the colon and reduced the incidence of postoperative complications to 7-10% (Nikitin A.M. et al., 1987; Artyukhina A.G. et al., 1992; and others). Despite the improvement of the mechanical suture, its main drawback - through flashing of the intestinal walls with the formation of a rigid scar ring - remained unchanged. Equally important for Russian surgeons is the high cost of modern stapling equipment.

 Fewer studies are devoted to the compression method of joining tissues. The modern stage of the theory and practice of this type of suture is associated with the names of domestic surgeons: N.N. Kanshina (1976-1995), Yu.F. Isakova et al. (1982); K. I. Myshkina et al. (1986, 1987); O.K. Skobelkin (1991); R.V. Ziganshin and his students (1981-1995) and others. To create a seamless anastomosis, they developed various designs of magnetic alloys; devices of the AKA, UKL-60, NZhKA series equipped with elastic clamps of compression; as well as the formation of anastomosis with a laser beam, etc.

 The indisputable advantages of the compression method of connecting fabrics over manual and mechanical sutures have already been proven (N.N. Kanshin et al., 1995; R.V. Ziganshin et al., 1995; B.K. Gibert, 1995 and others). Nevertheless, certain drawbacks are also inherent in them: the complexity and imperfection of the designs of apparatuses and devices, the puncturing of the connected intestinal walls, the complete opening of the lumen of the hollow organs for the introduction of compression rings when forming a terminal anastomosis or the formation of only a lateral interintestinal anastomosis, infection of the abdominal cavity, the inability to arbitrarily change the strength compressive elements, healing by secondary intention (Egiev V.N., 1995; Plotnikov V.V. et al., 1995; Sazhin V.P., 1995 and others). That is why the compression method of tissue connection is still not widespread in Russia, with the exception of the AKA apparatus.

 According to R.V. Ziganshina et al. (1995) more perfect among devices for creating inter-intestinal anastomoses are titanium nickelide implants with the effect of "shape memory" (ed. Certificate 1186199 from 06.22.85.), Developed by A.I. Makarov et al. The advantages of this method, taken as an analogue, are the simplicity and reliability of the formed anastomosis, high mechanical and biological integrity of the seam.

However, this device is designed to create gastrointestinal and small intestinal anastomoses side to side. Anastomosis is formed non-physiological, intestinal discomfort appears, post-resection syndrome, etc. In addition, in the wire device A.I. Makarova, the cross-sectional diameter of the wire is 0.9 mm, the inner size of the staple is 8 • (20-25) mm, the pressure between the turns on the connected tissues is 400 g / mm ^2, which is sufficient for “guillotine-free” tissue connection and prevention of primary anastomosis obstruction, since The diameter of the lumen of the small intestine of 5-7 mm is sufficient for the transit of liquid chyme. (N.A. Borodin, 1987).

 The large intestine, in contrast to the small one, has its own anatomical and physiological features: other sizes of the lumen, wall thickness, intra-intestinal pressure, high anaerobic-aerobic bacterial contamination, rounded solid chyme, etc. Therefore, neither in size, nor in shape, nor in the force of tissue compression, A.I. Makarov's device allows us to form a complete end-terminal colonic anastomosis, as we were convinced by conducting experiments on outbred dogs and corpses of adults.

 There is another original way to create a closed end-end anastomosis that we have chosen as a prototype (O.N. Rogachev. Terminal aseptic delayed anastomosis with spontaneous recanalization. // Diss. Cand. Medical Sciences, Tomsk, 1989).

 Its essence is as follows. The intestinal wall is dissected to the submucosal layer, which after ligation is crossed by an electric knife; the edges of the mucosa bandaged with catgut in the adducting and abduction departments are coagulated using the diathermy apparatus; stumps formed in this way come together, superimposed single-row serous-muscular sutures with silk thread. Patency of the anastomosis is restored spontaneously for 3-4 days after surgery. The study is mainly experimental in nature, the experience of operations in the clinic is small. The surgeons are impressed by the high asepticity of the formation of the anastomosis, however, the method is not widespread because of the danger of developing intestinal obstruction, since the lumen of the interintestinal anastomosis is not restored initially.

As for other devices and devices made of titanium nickelide - R.V. Ziganshina et al. ("Device for the formation of intestinal anastomosis end to end" - patent 2062052 from 06/20/96.), O.B. Ospanova ("A method and device for performing a seamless anastomosis with a superelastic implant with a shape memory. // Superelastic implants with a shape memory in medicine." Materials of the 7th International Conference, Russia, Novosibirsk, 1995, p. 113), V .IN. Plotnikova et al. ("Compression seamless anastomoses in colon surgery" - ibid., P. 136) and others - all of them have significant disadvantages:
1) the intestinal lumen is fully opened for the introduction of compression rings, which is fraught with the danger of bacterial contamination of the abdominal cavity;
2) equipment that is complicated in technical design and use for delivering a compression device to the connected ends of the intestine;
3) the imperfection of the primary restoration of patency of the anastomosis, etc.

 The aim of this study is to improve the results of colon surgery by improving the technique and quality of terminal anastomosis. It is realized by combining the submucosal-mucous layers of the intestine ends with a compression suture with the primary restoration of patency of the intestinal anastomosis: after removing the pathological focus without opening the lumen of the intestine, the submucosal-mucous layers are brought together and centered, punctured into the mesenteric edge, and the compression device turns into titanium nickelide, respectively each puncture is strictly transverse to the length of the intestine so that the bandaged stumps are clamped in the center of the staple device; only mucous-submucous layers are connected with a compression suture; the lumen of the anastomosis is restored by dissecting the restrained tissues with special scissors; the operation ends with suturing of the submucosal-mucous layers at the site of their punctures and superimposing on the outside of the compression suture line rare serous-muscular sutures.

 Starting this work, we knew that the pressure in compression wire devices is directly proportional to the cross-section of the wire (MZ Mirgazizov, 1993). Taking into account the peculiarities of the colon (see above), we increased the thickness of the wire from TN-10 to 1.9-2.3 mm, created a device shape close to round, increased the number of turns to 3 and sizes to 12 • 25, 15 • 30 mm.

 Figure 1 in a comparative aspect presents the device A.I. Makarova et al. and the variant we modified.

The pressure between the turns of our device is 600-800 g / mm ² . Experimental tests and calculations were carried out from the UTR strain gauge installation at the Tomsk Scientific Research Institute of Medical Materials and Alloys with a "memory" of the form under the guidance of Academician PATH V.E. Gunther. It is this design of the implant and such compression force on the connected walls of the colon that are most favorable for the formation of a terminal colonic anastomosis with timely rejection, isolation of the device naturally for 8-10 days, which was confirmed by experiments on outbred dogs at the Central Laboratory of Tyumen State Medical Academy and clinical tests.

 The implant is made of nickel-titanium wire brand TN-10 in the form of 3 rings in contact along the generatrix. Given the possible options for the colon in an adult, we selected 2 sizes of the device 12 • 25 and 15 • 30 mm with a wire cross section of 1.9-2.3 mm (Figure 1).

 The transverse size of the implant of 12-15 mm allows you to fix both stumps of the intestine in the lumen of the compression rings and dissect them to restore the primary patency of the anastomosis. This is facilitated by the minimum mass of stumps formed by ligation of only the mucous-submucous layers of the intestinal ends. The presence of 3 turns is also a favorable moment in the formation of the anastomosis, since this allows you to create tissue compression almost along the entire perimeter of the anastomosis (90-95%). In addition, an increase in the number of turns of the compression device enhances the degree of compression of the connected ends of the intestine (V. E. Gunther, 1989). However, A.I. Makarov’s staple device, consisting of 2 turns with a diameter of 8 mm, cannot accommodate both stumps, and therefore the implant turns after heating do not completely close due to the large array of stumps and the small diameter of the implant’s lumen, which ultimately leads to the failure of the anastomosis.

 The essence of our proposed operation is as follows. Oral to the pathological focus is a circular dissection of the intestinal wall to the submucosal layer (Figure 2). The serous-muscular layer is additionally secreted with a tupfer within 4-5 mm and is cut off. In the most distal section of this segment, the mucous-submucosal layer is tied with a catgut ligature, and one thread of the knot is cut off. Below, a clamp or a second ligature is applied and the intestine intersects between them without opening its lumen (Figures 3-4).

 In a similar way, the intestine stands out and crosses more aborally than the pathological focus.

 The main thing at this stage of the operation is the cutting off and removal of the affected area of the intestine without opening its lumen.

 The next stage of the operation is the convergence of stumps to each other by tension and ligation of the remaining threads on them, which leads to the alignment of the connected ends of the intestine (Figure 5). Another option is also possible - flashing and rapprochement of bandaged stumps with one thin catgut thread. Then, on the anti-mesenteric edge of the contacting walls of the stumps, 2 suture holders are superimposed. Proximal and distal of the nodal sutures, one on each stump, transverse punctures of the submucosal-mucous layers of a length of not more than 3-4 mm are made (Fig. 6). It is better to produce them with an electrocoagulator. After that, a cooled compression device with diluted turns is introduced through punctures into the lumen of the connected ends strictly transverse to the longitudinal axis of the intestine (Fig.6). As soon as the device forms back (under the influence of intestinal temperature) with stump compression, which is determined by an attempt to displace the device, the patency of the anastomosis is restored by dissecting the injured tissues inside the compression rings, as shown in Fig. 7, with special scissors with recesses in the branches (Fig. 8).

 Mucosal submucosal punctures are sutured with 2-3 interrupted sutures (Fig. 9), the holders are removed. Then, rare nodular sero-muscular sutures with absorbable suture are superimposed along the outer perimeter of the compression rings (Figure 10). This completes the operation.

 In contrast to the analogue and prototype, according to our method, the tissue is not compressed in all layers of the intestinal wall, but only in the mucous-submucous membranes with minimal short-term opening of the intestinal lumen. With this formation of the anastomosis, the formation of a rough rigid ring of the anastomosis is impossible - the main drawback of modern manual and mechanical sutures. Rare nodal sutures along the outer perimeter of the anastomosis with absorbable suture do not significantly affect the formation of a scar layer at the junction of the anastomosis.

 This method of forming an anastomosis is preferred for planned surgical interventions on the prepared intestines.

 One more option of operation is possible. It can be used not only for planned operations, but also for inconsistencies in the diameter of the connected ends of the intestine, as well as for a short stump. A large bowel resection is performed as described above. Further, after alignment, the ends of the intestine are fixed to each other by an additional 3 interrupted serous-muscular sutures - on the mesenteric edge and along the side walls, departing directly from the ends of the intestine in opposite directions by 1.5-2.0 cm (Figure 11). This expands the area of contact and corrects the mismatch of the diameters of the connected ends of the intestine. The device is also inserted through punctures of the mucous-submucosal layers, but when the turns of the joints are closed, all layers of the connected intestinal walls are compressed (Fig. 12, 13), which is associated with the application of 3 nodal sutures (see above).

 It is the uniform compression of the entire thickness of the walls of the intestine that allows you to refuse from the imposition of additional manual sutures outside the formed compression anastomosis. After rejection of the implant and its "exit" in a natural way, no foreign inclusions remain in the inter-intestinal anastomosis, that is, a completely seamless anastomosis is formed.

 Uniform compression of the ends of the intestine with a compression device is a more hermetic method of connecting tissues than the application of manual and mechanical sutures, which we tested by pneumocompression. With compression anastomosis, the mechanical strength of the anastomosis was impaired at a pressure of more than 120 mm Hg, with manual pressure - 80-90 mm Hg.

 The adaptation of the tissues of the same name in the absence of foreign inclusions between the connected walls promotes the early formation of an anastomosis without scar tissue deformation at the junction. The anastomosis is formed elastic, extensible, without stenosis in the long term - this is the main advantage of our proposed method.

 In urgent surgical interventions on an unprepared intestine, the 3rd option is more often used to prevent anastomotic insolvency. Oral and aboral to the affected area, the intestine is ligated with 2 catgut ligatures (without dissection of the serous-muscular layer) and intersects between them (Fig. 14-15). Transverse punctures on the connected stumps of the mesenteric edge are also carried out through the entire thickness of the intestinal wall (Fig. 16). The remaining stages of the formation of the anastomosis correspond to the above (Fig. 17). But with this method, we often resorted to overlaying the anastomosis of the unloading colostomy orally to prevent suture failure. The colostomy was closed in the early stages, without discharging the patient from the hospital.

The conformity of the claimed method to the criterion of "NOVELTY" is due to the presence of the following features that are absent in the prototype:
1. In contrast to the prototype, before the bowel resection, the sero-muscular layer is more oral and aboral than the pathological focus, not only circularly dissected, but also excreted within 4-5 mm and cut off. The connected stumps within 4-5 mm are deprived of the serous-muscular cover, which is enough to apply a compression suture between the submucosal-mucous layers of the connected intestinal walls.

 2. For the first time, a terminal compression anastomosis was created by connecting not the entire thickness of the walls, but the mucous-submucosal layers of the intestinal stump, which is accompanied by the formation of a minimal connective tissue layer at the junction of the connected intestinal ends.

3. For the first time, a terminal anastomosis of the colon is formed using a device from TN-10, consisting of 3 turns connected in a generatrix with a compressive force of compression elements on the tissue of 600-800 g / mm ² , which corresponds to the parameters and anatomical and physiological characteristics of the colon intestines and allows you to create an intestinal anastomosis in any part of the rectum and colon.

 4. A seamless end-terminal anastomosis of the colon was created, in which a temporary implant is inserted through punctures of the mucous-submucous membranes, and all layers of the connected walls undergo compression. Outside reinforcing seams are not superimposed. In all recently described seamless anastomoses described in the literature, there is always one or another number of manual reinforcing sutures.

The significance of the signs to achieve the goal is confirmed by the following:
1. Resection of the pathological section of the intestine is performed without opening its lumen, which minimally contaminates the abdominal cavity.

 2. In contrast to open methods for restoring intestinal continuity (both manual and mechanical suture) when connecting the ends of the intestine according to our method, the lumen of the hollow organ is opened minimally and for a short time, which significantly reduces infection of the abdominal cavity and complications of the anastomosis itself.

3. A wire device made of TN-10 in the form of 3 turns connected in a generatrix with parameters: 12 • 25, 15 • 30 mm, wire cross-section 1.9–2.3 mm, with a compression force between turns of 600–800 g / mm ² corresponds to the anatomical and physiological characteristics of the rectum and colon and allows you to create a terminal seamless colonic functionally complete anastomosis.

 4. Anastomosis is formed not due to compression of the entire thickness of the connected intestinal walls, but due to uniform compression of the mucous-submucosal layers, which is the prevention of incomplete closure of turns in AI devices. Makarova et al. due to the interposition of the tissue array between them with the primary leakage of intestinal contents into the abdominal cavity and the development of failure of the joints of the anastomosis and peritonitis.

 5. Direct restoration of the lumen during surgery by dissecting the restrained tissues reduces the intestinal pressure, improves the transit of the chyme and protects from primary obstruction of the anastomosis.

 6. The method allows to reduce the duration of the abdominal stage of the operation by more than 2 times compared with the manual formation of the anastomosis and is not inferior to the hardware connection of tissues.

 7. In contrast to manual and mechanical sutures during rejection of the titanium nickelide implant and its "exit" in the natural way on the 6-8th day after the operation, no foreign inclusions remain between the connected tissues, which contributes to the early formation and maturation of the anastomosis due to the best adaptation of the same tissue. This is only possible with glue or laser bonding of tissues, which is not widespread for technical reasons.

 8. Upon maturation of the anastomosis created by connecting only the submucosal-mucous layers with a temporary compression suture, a minimal connective tissue layer is formed at the junction of the ends of the intestine and, unlike manual and mechanical sutures, a mobile, extensible, functionally full-fledged anastomosis is formed without a tendency to stenosis in the long term.

 9. The use of a compression joint does not require sophisticated and expensive modern equipment. Temporary implants made of titanium nickelide with the effect of "memory" of the form are lightweight, miniature, streamlined in shape. Their cost is 10-15 times cheaper than modern stapling equipment.

 10. The operations we developed to form the terminal colonic anastomosis are simple to perform, safe, and have clear indications for use. The method is an alternative to modern methods of connecting tissues. We use it even for bacterial contamination of the abdominal cavity, but the operation thus ends with the application proximal to the anastomosis of the discharge colostomy.

 Thus, the claimed combination of features leads to the achievement of the goal.

 The compliance of the claimed solution with the criterion of "SIGNIFICANT DIFFERENCES" is confirmed by the absence in the patent and scientific literature of information on methods for a similar purpose having the above set of features.

 The invention is confirmed by illustrations (Fig.1-17).

 FIG. 1. Comparative data of compression devices A.I. Makarov and our design option.

 Figure 2. Layered section of the colon wall.

 FIG. 2a. Circular dissection, the allocation of the serous-muscular layer of the intestinal wall to the mucous-submucosal layer.

 FIG. 3. Ligation of the mucous-submucous layers of the intestinal wall with catgut ligature, the application of a crushing clamp aboral to the ligature.

 Figure 4. Type of colon stump after crossing and removing the affected area of the colon.

 FIG. 5. Rapprochement and alignment of the connected ends of the intestine by tensioning and dressing the remaining threads on them.

 FIG. 6. The introduction of a cooled compression device with diluted turns through punctures of the mucous-submucosal layer.

 7. Restoring the primary patency of the anastomosis by dissecting the restrained tissues inside the compression rings.

 FIG. 8. Scissors with recesses in branches to restore the primary patency of the anastomosis.

 Fig.9. Suturing of punctures of the mucous-submucosal layer with interrupted sutures.

 FIG. 10. The imposition of rare serous-muscular sutures along the outer perimeter of the compression rings.

 FIG. 11. 2nd option of the operation - after resection of the colon and alignment, the connected ends of the intestine are additionally fixed to each other by the 3rd serous-muscular interrupted sutures - on the mesenteric edge and side walls.

 FIG. 12. The introduction of a cooled compression device through punctures of the mucous-submucosal layer.

 Fig.13. The final type of anastomosis.

 Fig.14. The 3rd option of the operation - the colon is bandaged with 2 catgut ligatures, more oral and aboral than the pathological focus, without dissection of the serous-muscular layer.

 Fig.15. Type of colon stump after resection of the affected area.

 FIG. 16. The introduction of a cooled compression device through punctures of all layers of the intestinal wall.

 Fig.17. Suturing of punctures of the intestinal wall with serous-muscular sutures.

The invention is illustrated by the following experiment on a purebred dog Anchord:
Outbred adult dog Anchord, weight 10 kg, was operated on 02.03.99 (protocol of operation 2). Under intravenous anesthesia, a laparotomy was performed, a resection of the transverse colon with the formation of an end-end compression anastomosis using a TN-10 titanium nickelide device consisting of 3 turns in contact with the generatrix, with parameters: 12x25 mm, wire cross-section diameter 1.9 mm . The operation technique corresponds to FIG. 2a-10. After the operation, a control survey radiography of the abdominal organs was performed. A compression device in the anastomosis zone (Fig. 18). In the postoperative period, no complications were detected. The rejection of the compression device on the 8th day after the operation, which is confirmed by a survey picture of the organs of the abdominal cavity 10.03.99, (Fig.19). The device has departed naturally.

 Our proposed method for connecting the ends of the colon was tested in an experiment on 10 dogs. In the clinic, it has been successfully used in 2 patients with acute intestinal obstruction.

Sources of information
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Claims (1)

A method for the formation of an end-terminal anastomosis of the colon, including dissection of the serous-muscular membranes of the intestine more oral and aboral than the pathological focus, dressing, excision and removal of the affected area, rapprochement and alignment of the deserted ends of the intestine, puncture of the mucous-submucous layers on each stump, introduction through each puncture a cooled device made of titanium nickelide, which takes the form of three turns, in contact along the transverse generatrix of the intestine with parameters 12x25 mm and 15x30 mm, wire cross section 1.9-2.3 mm compression force between coils 600-800 g / mm ² with clamping stump tied at the center of the compression device, restoring the lumen anastomosis by dissection disadvantaged tissue, suturing of punctures connectable intestines walls.

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