WO2016043622A1

WO2016043622A1 - Method and device for forming surgical anastomoses

Info

Publication number: WO2016043622A1
Application number: PCT/RU2015/000548
Authority: WO
Inventors: Сергей Александрович ГРИШАНКОВ
Original assignee: Сергей Александрович ГРИШАНКОВ
Priority date: 2014-09-15
Filing date: 2015-09-01
Publication date: 2016-03-24

Abstract

The invention relates to the field of medicine, and more particularly to surgery, and is intended for forming anastomoses using double-armed surgical sutures. A device for forming surgical anastomoses using sutures with a needle at each end (double-armed sutures) comprises: a housing in the form of an elongate body having end parts designed for introduction into the lumens of organs that are to be joined; and needles disposed in the end parts of the housing, wherein one needle of each suture is disposed in one end part of the housing and the other needle is disposed in the opposite end part; the end parts are provided with openings for the needles, which openings are arranged equidistantly around the circumference, and the needles are disposed in the aforesaid end parts in such a way that the blunt end of the needle at the point of connection with the suture is located closer to the edge of the end part, and the sharp end of the needle faces in the direction of the relevant opening and does not protrude beyond the outer surface of the housing, wherein the needles are capable of moving through the openings in the end parts, at least a portion of the needle exiting through the openings in order to pierce the organs that are to be joined.

Description

METHOD AND DEVICE FOR FORMING SURGICAL

ANASTOMOZOV

Technical field

The present invention relates to medicine, namely to surgery, and is intended for the formation of anastomoses using two-needle surgical sutures.

The invention can find application in pediatric surgery, transplantology, cardiovascular surgery, in operations on the liver, pancreas, ureters, urethra, microsurgery, etc.

State of the art

In surgical practice, anastomosis is an artificially created message (anastomosis) between the hollow organs, and the invention will allow the formation of a connection between two hollow or tubular structures, or a tubular structure with a hollow organ. Structures can be part of various systems, such as cardiovascular, digestive or genitourinary.

The prior art various devices for the formation of anastomoses, which can be divided into several groups according to the type of materials used: with compression rings, with metal staples (clips), with suture material (surgical sutures).

Examples of devices that use compression rings to form anastomoses are described in US3258012, US5336233, US6569173. These devices are typically used to connect blood vessels. In most cases, these devices work as follows: the walls of two connected vessels are unfastened (everted) on two rings and fixed to them using spikes, teeth or in another way - each compression ring is fixed to the end of each connected vessel. Further, the rings are connected to each other by a compression method, i.e. compression rings are pressed against each other and fixed in a compressed state.

However, such devices are characterized by the complexity of use with a small diameter of the vessels to be connected, the complexity of wall eversion vessel with its atherosclerotic lesion. In addition, the constant presence in the body of a foreign material from which the compression rings are made is negative, and therefore the trophism of biological tissue in the area of the compression joint is impaired. In addition, these devices have restrictions on the use in pediatric surgery - as with the growth of an organ, the ring becomes an obstacle to its normal operation.

Examples of devices that use metal staples (clips) of various configurations to form anastomoses are presented in patents RU2055541, US6461365, US366462, US5779718. Staples during bending (deformation) fix the connected organs. The staples themselves can be placed in trays (stores) of which are consumed as the anastomosis is performed.

However, such devices are characterized by the complexity of the application with a small diameter of the connected organs, the invasiveness of the technique with respect to the connected biological tissues, negative consequences arising from the constant presence of foreign material in the body, impaired blood microcirculation in the connection zone, the possibility of scar tissue development at the site of mechanical connection, the inverted nature of the connection. In addition, to perform anastomoses using the above devices, it is necessary to form an additional hole in one of the connected organs for insertion and extraction of the device itself (stapler), which limits the use of these devices.

Examples of devices that use surgical suture for the formation of anastomoses are presented in US4553543, US5554162, US20110306994, US6280460, US6358258, US6896685, US20020055752, US2010114121, US5320632. This group of devices is close in essence to the proposed invention.

The device according to patent US4553543 consists of two rods with many longitudinal grooves for surgical needles. The rods have a complex profile. One of the end sections (distal) of each rod is made cylindrical, the adjacent section is made with a gradually increasing diameter, which in turn is interfaced with a section of a conical shape that passes into an end section (proximal) of a cylindrical shape with a rounded end, intended for insertion into the lumen of a stitched organ. A sleeve is arranged at the distal end portion of the rod that is movable along the said portion of the rod until it mates with a portion that has a gradually increasing diameter, and is also equipped with a plurality of longitudinal grooves for placing needles with surgical threads in them. In this case, the sleeve is located with a gap from the adjacent (adjacent) section, and the needles are laid in such a way that the blunt end of each needle is located in the grooves of the sleeve, and the sharp one is in the grooves of the section with increasing diameter. Thus, the sharp end of the needles is oriented towards the proximal end of the rod. The sleeve with the needles and threads installed in it is closed outside by an additional casing, which does not allow the needles to carry out independent uncontrolled movement along the rods. The formation of the anastomosis is carried out by alternately introducing the rods with the needles threaded into them into the lumen of the connected organs, followed by the movement of the sleeve (using the pusher) until they mate with the portion of the rod with an increasing diameter, as a result of which the needles, moving in grooves that perform the function of guides, go outside and pierce the wall of the vessels, after which the needles are removed with the subsequent formation of surgical nodes.

However, the extension of the needles with a puncture of the vessel wall is carried out in the opposite direction from the crossed end of the vessel (i.e., deep into the vessel). This circumstance narrows the scope of the device - only for connecting vessels of the "end to end" type, and does not allow to connect the vessels "end to side" or "side to side", or to stitch the ducts of parenchymal organs, because these types of compounds require the release of the vessel wall from surrounding organs and tissues at the point of exit of the needle from the vessel wall. In addition, during the formation of the anastomosis, the probability of the vessel slipping off the rod during and after piercing its wall with needles is high. In addition, the design of the device does not provide an orderly laying of threads, which significantly complicates the use of the device in the surgical field, and also does not provide a mechanism for the orderly distribution of threads after flashing vessels, which significantly increases the risk of tangling of the threads during their binding. In the process of using the device there is a high probability of changing the relative orientation of both rods relative to each other friend, which violates the alignment of the connected vessels and the accuracy of the connection.

The device according to patent US5554162 consists of a cylinder, inside of which on the opposite sides there are two pistons, in which several surgical threads with curved needles are fixed at the ends. The method of flashing hollow organs consists in alternately introducing the ends of the cylinder into the lumen of the hollow organ and conducting surgical needles through the wall of the organ due to the translational movement of the piston inside the cylinder using a special pusher. After flashing both hollow organs, the needles are removed and the threads are connected.

This device has the following disadvantages: the use of bent needles and the peculiarity of their placement inside the cylinder does not allow using this device for flashing hollow organs of small diameter (less than 5 mm) and using more than 4 needles to form a reliable connection of organs; the threads between the surgical needles are located outside the cylinder and do not have an ordered arrangement, which increases the likelihood of them becoming entangled during operation of the device; the lack of stock of the length of the threads due to the peculiarities of their location in the device does not allow the surgeon to reliably form a surgical node; the extension of the needles and puncture of the vessel wall is carried out in the opposite direction (forward) from the crossed end of the vessel, which, as in the previous analogue, limits the use of the device only for a certain type of end-to-end vessel connection; there remains a high probability of the vessel slipping off the cylinder during the piercing of its wall with needles, there is no orderly laying of threads in the device, which significantly complicates the use of the device in the surgical field.

The device according to patent US6280460 consists of a handle with a mechanical drive and a working rod, including several concentrically arranged hollow cylinders, made with the possibility of moving relative to each other in working condition. In the central cylinder (the smallest diameter) there is a rod with a tip in which direct surgical needles with threads are fixed with a blunt end. The folded needles are parallel to the axis of the shaft and held by the cylinder. After introducing the end of the rod into the lumen of the hollow organ, thanks to to the mechanical drive in the handle of the device, the cylinders move in the rod, which leads to the transition of the needles from the "folded" - axial position to the open, in which the sharp ends of the needles are turned to the opposite side from the end of the rod. With the reverse draft of the device, the needles penetrate the organ wall around the circumference and are sequentially removed.

However, this device allows you to flash only one hollow organ. In addition, the fixation of the needles on the tip of the rod is not reliable, and in the open state does not provide the location of the sharp ends of adjacent needles at an equal distance from each other, which reduces the quality and reliability of the connection of stitched organs.

Closest to the claimed invention is a device for the surgical connection of hollow organs, presented in the patent for utility model RU 141181. The device contains a base of cylindrical shape with cone-like narrowing on both sides, turning into cylindrical rods with sharp points at the end. On the basis of the grooves are made for surgical sutures, and the grooves are made continuing on a cone-shaped narrowing. By means of rods, the base is connected to two nozzles of a cylindrical shape. The peripheral end of each nozzle has a pointed shape, on which there are holes for installing the blunt ends of straight needles connected to surgical sutures. The base has a removable shell of a cylindrical shape, consisting of two halves, each of which has two wings, located opposite each other in the middle part of the shell in the area of contacting surfaces, and connected by means of removable brackets. The diameter and size of the base are selected taking into account the diameter of the connected structures.

Surgical connection of hollow organs, for example, of the "end to end" type, is carried out in the following sequence. First, the pointed end of the nozzle, together with the needles, is inserted into the lumen of one of the connected hollow organs. Then produce a reverse traction (traction) of the device from the lumen of the hollow organ, while the tips of the needles pass through the wall of the stitched hollow organ and appear on the outer surface of the organ. After that, the tips of the needles are captured with surgical clamps and, in turn, removed together with the threads from the device to a distance convenient for the surgeon for subsequent manipulations. After extraction all needles the nozzle is removed from the lumen of the hollow organ. The above operations are repeated in the same sequence with respect to the second connected hollow organ using a nozzle located on the opposite side of the base. After flashing the connected organs, fixing brackets are removed from the wings of the outer shell and both halves are removed from the base of the device. All threads are alternately released from the grooves (slots) of the base. The base of the device is removed from the surgical field, and then alternately tying the threads until the two hollow organs are completely connected. After tightening all the nodes, free threads are cut.

In this device, the needles are inserted into the nozzle openings at a certain angle in such a way that the sharp ends of the needles are facing outward, and the ends of the needles connected to the thread are turned towards the pointed end of the nozzle, while in the “folded” and “working” states of the needle its sharp ends beyond the outer surface of the nozzle. Thus, with the introduction of a tip with needles protruding from it into the lumen of the connected organ, injury to the organ wall with the sharp ends of the needles is possible. In addition, the inventive device does not allow the possibility of re-introducing the tip for the case if the initial introduction was performed with certain inaccuracies (for example, violation of the coaxial location of the tip and the vessel, leading to a decrease in the quality of the connection), because when the tip is removed from the vessel after its initial introduction, the organ walls are automatically flashed. In addition, the lack of a handle (base holder) in the design of the device leads to inconvenience during its use, because does not provide the required freedom to manipulate the tip during the surgical operation. In addition, the design used a complex pattern of laying the threads in the base volume, which leads to the risk of tangles in the process of binding.

The inventive device overcomes the above disadvantages of all analogues and prototype.

Disclosure of invention

The objective of the invention is to develop a new device for the formation of anastomoses using surgical sutures with needles at both ends, ensuring the implementation of high quality compounds. The technical result to which the claimed invention is directed is the ability to simplify the process of forming an anastomosis in surgical practice and to obtain a better and more reliable connection of a wide range of hollow organs or hollow or tubular structures, including end-to-end, end-to-end vessel connections side by side or side by side; ducts of parenchymal organs, which are part of the cardiovascular, digestive and genitourinary systems and other systems. At the same time, a high quality of the connection is achieved by the possibility of positioning the “stitching” part of the device in the lumen of the connected organ until the organ walls are pierced with needles, the moment of piercing is controlled, and the puncture points are evenly located in the walls of the organs being stitched together at an equal distance from each other and from the edge of the crossed organ (vessel) (if necessary). In addition, the claimed device is characterized by ease of use in connection with the possibility of complementing the design of the claimed device with a holder. Moreover, the design of the holder provides for the possibility of placing loops of each thread that are formed when the needles are fixed at opposite ends of the device, without the risk of tangling, both when the walls of the organ are stitched with needles and the subsequent formation of the surgical unit. The design of the holder allows the use of threads with a length of 35 - 50 cm, which is optimal for ease of use by the surgeon when forming a high-quality knot. In addition, the inventive device allows you to stitch small vessels with a diameter of from Zmm to 5mm, which is important in pediatric surgery, microsurgery and transplantology, as well as form erected sutures, which is especially important in vascular surgery.

In addition, the claimed device in the case of inaccurate installation of the device in the lumen of the stitched vessel allows you to adjust its position by removing the device from the vessel without punctures or damaging its walls with the sharp ends of the needles and reintroducing the device without extending the needles. In the absence of errors when introducing the device into the lumen of the stitched vessel, the walls are punctured with needles to ensure uniform distribution of puncture points in the stitched vessel, which provides more accurate suturing, and as a result - greater tightness.

The problem is solved in that the device for forming surgical anastomoses by means of threads with two needles at the ends (two-needle threads) includes a body in the form of an extended body (for example, a sleeve) having end parts (or tips) made with the possibility of introducing into the lumen of the connected organs ; needles located in the ends of the body (or tips), with one needle of each thread located in one end of the body, and the second needle in the opposite; the end parts are provided with needle holes located around the circumference at equidistant distance from each other, and the needles are located in the said end parts so that the blunt end of the needle at the junction with the thread is located closer to the periphery of the end part, and the sharp end is turned to the side the corresponding hole (or directed to the central part of the body) and does not protrude beyond the outer surface of the body, while the needles are made with the ability to move through the holes of the end parts with the exit at To the least, parts of the needle through the aforementioned holes to provide a puncture of the connected organs. Most preferred is the implementation of the extended body (body) in the form of a sleeve, while the end parts of the extended body (body) can be made in the form of tips, which can be made integral with the sleeve in the form of a single part, or removable as separate parts. In this case, the housing can be made integral of at least two parts, for example, two bushings.

Preferred is the location of the needles at an acute angle to the longitudinal axis of the extended body (from 5 to 90 degrees). In this case, the needles can be made straight or with a radius change in curvature. To move and exit the needles through the holes of the end parts and to provide a puncture of the connected organs, the device is equipped with a displacement means located in the end part of the body and made in the form of a piston with a traction element. The piston is provided with grooves for accommodating needles, the traction element can be made in the form of a cable or it can be a mechanical lever system. The piston can be made with the possibility of "manual" movement or automatic movement, for example, using a spring mechanism associated with the traction element.

In addition, the device may be provided with guides for moving the needles through the holes in the end parts of the housing; means for placing loops formed by threads from the corresponding pairs of needles after laying them in the end parts of an extended body; holder of an extended body. When performing the inventive device with a holder, means for placing loops can be located in it. In one embodiment, the holder comprises a housing with a rod located therein, rigidly connected to an extended body in its middle part, while the means for placing the loops is a set of hollow tubes parallel to the rod, and the number of tubes selected is not less than the number of threads used. In this case, the holder may be equipped with needle movement controls.

The number of holes made in the end part of the body (or tip) is determined by the inner diameter of the stitched organs and must correspond to the number of needles located in the end part.

The threads can be made with marking, for example, color.

The device can be equipped with at least one latch (distributor) of threads made with the possibility of fixing the threads after removing the needles from stitched organs. The clamp (distributor) of the threads is removable. In one embodiment, the latch (distributor) of the threads consists of a spring with tightly arranged coils, fixed in a housing made with compartments for individual threads, providing access to the spring for securing threads and / or needles between the coils of the spring.

The device can also be equipped with guides for threads coming out of the holes of the end sections and located on the side of the outer surface of the housing. In one embodiment, the guides for the threads are made in the form of a ring with slots along its outer contour. In another embodiment, the guides for the threads are grooves made from the outer surface of the housing. The problem is also solved by the fact that the method of forming surgical anastomoses of the hollow and / or tubular organs using threads with two needles at the ends includes the following steps: a. the introduction into the lumen of one of the connected hollow organs of the inventive device with one end part with needles laid in it; b. the movement of the needles with sharp ends through the openings of the end parts of the inventive device in the direction from the periphery of the sleeve to its center with a puncture of the walls of one of the connected organs,

at. the introduction into the lumen of the second of the connected hollow organs of the second end part of the device;

d. the movement of needles with sharp ends through the holes of the second end part of the inventive device is similar to item b with providing a puncture of the walls of the second of the connected organs,

e. alternately capturing the protruding sharp ends of the needles and removing the needles together with the thread, followed by their fastening in the thread lock;

e. removing the device from the lumen of the stitched organs, and tying the threads alternately until the organs are completely connected.

To perform an everted suture, additionally after the needle pierces the organ wall before removing the needles from the organ wall and the device, each needle is punctured again alternately to the organ wall closer to its edge.

Brief Description of the Drawings

The claimed invention is illustrated by drawings, where in Fig.1 shows a General view of the inventive device Assembly, in Fig.2 - "working" part of the device in a disassembled state; in Fig.Z - a surgical needle with two straight needles at the end; figure 4 is an example of a piston, a General view; figure 5 is a piston, side view; in Fig.6 - the "working" part of the device assembly, including two bushings, in the end parts of which there are pistons, the device is presented in a "non-working" state, in which the needles are "hidden" in the device (or in the housing of the working part of the device) ; in Fig.7 - presents the "working" part of the device in position with the needles partially pushed outward as a result of the displacement of the piston from the extreme "inoperative" position to the "working"position; on Fig - a variant of laying surgical sutures in the holder; figure 9 presents a diagram "Manual" button movement on the device holder; figure 10 is an embodiment of a device with automatic movement of pistons; figure 1 1 - design of a removable retainer (distributor) of threads; on Fig - the appearance of the device (frontal plane) with attached clamps (distributors) of threads to the body of the holder; in Fig.13 - 22 presents a diagram of the anastomosis of two organs, for example, vessels; wherein, in Fig.13 presents a positioning diagram of the device opposite the connected organs; on Fig - the introduction of the end of the device into the lumen of one organ; on Fig stitching of the organ wall with needles; in Fig.16 - the introduction of the second end of the device into the lumen of the second organ; on Fig - flashing the walls of the second hollow organ; on Fig - removing the needle with the thread from the device with the placement of the thread in the compartment retainer threads; on Fig - image of the distribution of all threads in the latch; in Fig.20 - the removal of the thread clamps from the device (holder body) and their dilution to the sides; on Fig - the result after tying threads (the connected ends of two organs); on Fig presents a diagram of the implementation of the evert seam.

The positions in the figures indicate: 1 - an extended body (or body), for example, in the form of a sleeve; 2 - end part of an extended body, for example, a tip; 3 - surgical sutures; 4 - needles of surgical sutures; 5 - holes for needles 4; 6 - the piston; 7 - grooves (grooves) of the piston for laying needles; 8 - holes in the piston for installing the blunt ends of needles with threads; 9 - a piston cable; 10 - grooves for guides located on the side of the inner surface of the sleeve (not shown in the drawings) for moving the piston along them; 1 1 - holder (handle); 12 - holder body; 13 - rod holder; 14 - tube holder; 15 - latch button; 16 spring for the piston cable 9; 17 - scale of the displacement of the piston; 18 - thread lock; 19 - thread lock housing; 20 - spring retainer threads; 21 - compartments of the clamp for threads; 22 - a hollow organ; 23 - surgical clamp; 24 - bushing hole for the piston cable 9.

BEST MODE FOR CARRYING OUT THE INVENTION The following is a more detailed description of an embodiment of the invention.

The device (tool) contains a "working" part, made in the form of an extended hollow body 1 with end parts 2 (making up the body of the "working" part), in which surgical sutures 3 with two needles 4 are located at the ends (Fig.Z), and other structural elements that ensure the execution of anastomoses (see Fig.1 - 22). At the same time, needles are laid in one end part of the device for piercing one of the organs to be sewn, and the second pair of needles for piercing the second organ are located in the opposite end of the device. In the “inoperative” state, the needles 4 are located inside the end parts (“hidden” inside the case), and in the “working” state when piercing the stitched organs, the needles move through the holes 5 in the end parts, piercing the walls of the connected organs. In this case, the needles move with their sharp ends in the direction from the periphery of the device to its central part. The number of threads 3 used in the device is determined by the diameter (size) of the stitched organs. Each thread 3 may have a corresponding color and / or other markings (in full or in separate areas, for example, near the junction with the needles). An extended body (body) in cross section can have a different profile - in the form of a circle, ellipse, polyhedron, etc. The end parts 2 of the extended body 1 are made with the possibility of introducing into the lumen of the connected hollow organs and / or tubular structures. It is preferable to make the housing 1 in the form of a sleeve (which can be composed of two or more parts), and the end parts 2 in the form of tips (or nozzles), which can be made integral with the sleeve, or removable as a separate part connected to sleeve by any known means. The size of the sleeve and tips depends on the diameter of the connected hollow organs.

Tips 2 have an end surface, the shape of which ensures its safe introduction into the lumen of the connected organ (vessel). Most preferred is the implementation of the tip with a rounded end, for example, spherical or conical shape. In one embodiment, the tip has a cylindrical part mating with a rounded part, while the cylindrical part has geometric dimensions that enable the tip to pair with the opposite “open” end to the device sleeve. In another embodiment, the sleeve with the tip is made in the form of a single part, while the housing of the "working" part is composed of two such parts, as shown in figure 2. The diameter of the sleeve 1 depends on the diameter of the hollow or tubular organs for the connection of which the device is intended. Because the claimed invention can be used to perform various types of connections and various hollow organs and tubular structures, then, accordingly, the device can be made in the form of a size range with different diameters of the sleeve (working part of the device) to implement the corresponding connection. The minimum possible sleeve size, which can be manufactured using modern technical means, and in the tip of which the necessary number of needles can be laid for the formation of anastomoses, today is 3 mm. Such a device will allow stitching of tubular structures (vessels and ducts) with a diameter of 3 mm or more.

The end parts 2 (tips) of the claimed device are provided with holes 5 for needles 4. The holes are located around the circumference of the tip at an equidistant distance from each other and from the peripheral end of the tip. The location of the holes 5 from the peripheral end of the tip is determined by the ability to place the needles inside the tip so that the sharp ends of the needles are located in the area of their corresponding holes 5. The number of holes depends on the number of threads used to connect the hollow organs. For example, for organs with a diameter of 3 to 5 mm, it is recommended to use a device with a diameter of an extended body of Zmm, and choose the number of holes equal to 4 - 6.

In the inventive device, both straight needles and curved (with a radial bend) can be used, most often used to form surgical anastomoses of tubular structures in a "manual" way. The most preferred is the use of straight needles in the inventive device in connection with the possibility of their most compact arrangement in the device and the implementation of a more controlled and accurate flashing of the organ wall (Fig. 3). The length of the needles and threads can be different and depends on the diameter of the hollow or tubular organs, for the connection of which they are supposed to be used. The surgical thread located between the needles may be in a “folded” state inside or outside the device. Each thread and / or needle may have a corresponding marking (color or other) that distinguishes them from each other. Needles 4 are laid in the tip so that the blunt end the needle, atraumatically connected to the surgical thread, is located closer to the periphery of the tip 2, and the sharp end of the needle is turned in the opposite direction - towards the central part of the device (or sleeve). Thus, in the device in the assembled form, the needles of each thread, laid in opposite tips, are oriented towards each other. In this case, the best embodiment of the inventive device is represented by placing the needles at an acute angle to the axis of the sleeve (or tip) in such a way that the sharp end of the needle 4 in the “inoperative” state does not protrude beyond the outer surface of the tip 2, i.e. can be located in its hole 5 or near it. In the "working" state, the needle moves beyond the tip, while the movement of the needle can be achieved using any means known from the prior art, for example, with a piston 6. In this case, the tool (or mechanism) for moving the needle (for example, a piston mechanism) allows for controlled extension of the sharp end of the needles.

The piston mechanism of the device contains two pistons 6 (Fig.4 - 7), each of which is located in its tip and is made with the possibility of movement inside the tip and the sleeve using the traction element. On the surface of the piston, grooves 7 can be made, for example, wedge-shaped (see FIG. 4), into which the needles are placed, and which can serve as guides for the needles when they are moved from the “inoperative” position to the “working” position. The piston 6 can also be equipped with elements or devices for fixing the blunt end of the needles, for example, in the form of holes 8. When the tips 2 are removable, for example, in the form of nozzles on the sleeve, the end face of the sleeve can serve as a limiter for moving the piston inside the sleeve. In another embodiment, the piston can move both inside the tip and inside the sleeve, while other structural elements can perform the function of the limiter for moving the piston. The function of the traction element can be performed, for example, by a cable 7 connected to the piston 6. To prevent changes in the axial position of the piston inside the sleeve during operation of the device, special devices are provided (for example, grooves 10 on the piston and corresponding ribs on the inner surface of the sleeve of FIG. 4) The device may also include a holder 11 (or handle) (figure 1), connected to the housing of the "working" part (sleeve 1). The holder can be attached to the sleeve at its center or otherwise, while the method and angle of attachment of the holder can be different, ensuring the convenience of its capture and positioning of the "working" part of the device when performing an anastomosis.

In one embodiment of the holder, it comprises a housing 12 oriented perpendicular to the sleeve of the inventive device, in which a rod 13 is located, rigidly connected to the sleeve in its center, and hollow tubes 14 for placing loops from surgical sutures in them located around the rod (parallel to the rod ) (Fig. 8). In this case, it is preferable to make a holder with the number of tubes equal to the number of threads used in the device - one tube contains a loop from one thread laid in it, which ensures that the thread is removed from the tube during organ suturing without the risk of tangling it with adjacent threads. The housing of the device holder may have a different shape, for example, in the form of a parallelepiped or cylinder. The holder can also be equipped with two snap buttons 15, each of which is connected to the free end of the cable 9 of the piston 6, located on the outer surface of the housing (Fig.9). In one embodiment of the device, the latch button is configured to "manually" move the piston. In this case, the movement of the latch button is carried out in the housing 12 of the holder 11 in the vertical direction. In the “inoperative” position, the latch button 15 is in its lowest position on the body and holds the cable 9 in a “taut” state, when moving the latch button from the lower position to the upper one, for example, using the surgeon’s finger, the piston 6 is moved in the tip, which in turn “pushes” through the holes 5 the needles 4 threaded into the piston outside the tip. T.O. through the cable 9, the traction is transmitted from the latch button to the piston 6 inside the sleeve 1. A scale with marking 17 can be applied to the surface of the housing of the device holder, which allows visually assessing the amount of piston movement. Possible "automatic" embodiment of the movement of the piston 6 (figure 10). For this, the free end of the cable 9 can be fixed in the housing 12 of the device holder 11 from the inside by means of a spring 16 or other device. In this case, the latch button 15 mounted on the housing holder, blocks the movement of the cable. When this button is pressed, the cable moves under the action of the spring traction and moves the piston from its extreme position in the direction of the hub center. There are other possible implementations of the mechanism for moving the piston 6.

The device includes at least one removable lock

(distributor) of threads 18 (Fig. 1 1), which provides fixation of the threads after puncture and removal of needles from the device (i.e., after each needle flashing the walls of the organ to be stitched), preventing the threads from tangling after removing the needles. The size and shape of the thread lock may vary. The latch 18 can be placed on the housing 12 of the holder 11 using removable fasteners (the design of the fasteners can be different - mechanical, for example, in the form of a mechanical connector, magnetic, with a sticky surface, etc.) (Fig. 12).

In one embodiment, the thread lock 18 consists of a housing 19 in which the thread holding device is located. As such a device, a spring 20 with tight turns or another element fixing the thread (for example, adhesive tape, a plate with slots, etc.) can be used. The housing 19 of the thread retainer 18 may have slots (compartments) 21. The number of slots (compartments) depends on the number of surgical threads installed in the device. Opposite each slot, appropriate marking (for example, color marking) can be made, matching the color marking of the threads and / or needles, ensuring that both ends of one thread in each compartment are exactly aligned.

The device can also be equipped with two guides for threads (not shown in the drawings), made, for example, in the form of a ring located on the outer surface of the sleeve or tip on opposite sides of the holder, and provided with slots for threads in an amount equal to the number of threads. Moreover, each slot on the ring is located opposite the corresponding hole of the tip. The surface of the ring (slot for the thread) may also have color and / or other markings for each thread. The guides for the threads ensure their uniform placement on the outer surface of the sleeve of the device in its "idle" state and may have a different design. The inventive device can be made of any materials suitable for the implementation described by each structural element of the function. In this case, it is preferable to perform the elements of the device from a polymer material or plastic.

Assembly of structural elements of the device can be implemented as follows.

Separately, the body parts of the “working” part of the device are manufactured, for example, as shown in FIG. 2, which are assembled in a certain sequence shown in this figure. Then the threads with needles are “tucked” into the appropriate tips. To do this, each of the needles at both ends of the surgical thread is inserted with a blunt end (the end connected to the thread) inside the tip 2 through the corresponding holes 5 and fixed in the piston 6. The sharp end of the needle 4 is inside the tip and does not protrude beyond the outer boundary of the sleeve surface, and the surgical thread, located between the needles inserted into the tips, is formed in the form of a loop on the outside of the device and placed in a separate tube 14 inside the device holder 11 in a moderately tensioned state (see Fig. 8).

The device operates as follows (see Fig.13 - 22).

Both tips of the device are positioned opposite stitched tubular and / or hollow organs 22 (see Fig. 13). One of the tips is inserted inside the first hollow organ (Fig. 14), after which, by shifting or pressing the first button 15 on the device holder, the sharp ends of the needles 4 are moved from the holes of one tip and the needles are pierced by the walls of the first organ (Fig. 15). After that, the second "free" tip is inserted inside the second hollow organ (Fig. 16). By shifting or pressing the second button on the device holder, the sharp ends of the needles are moved from the holes of the second tip and the needles are pierced by the walls of the second organ (Fig. 17). The needles passing through the organ wall are alternately removed from the device using a surgical clamp 23 or other instrument, flashing the organ wall. The threads passing through the organ wall are fixed in the latch 18 - in the corresponding compartment 21 in compliance with color and / or other markings, i.e. both ends of the same thread fall into one compartment (Fig. 18). This technique is repeated alternately with each needle and thread in both tips (Fig. 19). Both clamps 18 with threads are removed (disconnected) from the holder 11 of the device and bred into opposite sides (Fig.20). The device is removed from the stitched organs, and the threads are tied in turn until the hollow or tubular organs are fully connected (Fig. 21).

Using the inventive device, it is also possible to perform an everted suture - when the inner surfaces of the connected tubular organs are in contact, in this case, after piercing the walls of the organ with needles, re-stringing the walls of the organ or vessel onto each needle. This manipulation is performed using tweezers with both ends of the connected organs (Fig.22).

The inventive device was tested for the formation of anastomoses between vascular prostheses with a diameter of 5 mm and cadaveric (taken from the corpse) arterial vessels, with an inner diameter of about 5 mm (a fragment of the common hepatic artery) of the "end to end" type. For this, a device was used with an outer diameter of the sleeve 5 mm, a length of 80 mm, the number of threads - 6 and, correspondingly, holes in the tip of 6 on each side.

As a result of the test, the formation of a sealed anastomosis was noted, which was checked and confirmed by a hydraulic breakdown under a pressure of 100 mm. mercury column. On visual inspection, the exact distribution of the joints of the anastomosis relative to each other around the circumference of the anastomosis and relative to the edges of the stitched vessels was noted.

A comparative test was conducted of the formation time of the anastomosis using a manual suture (traditional) and using the above device. It was noted that an anastomosis formed by a manual suture was spent 25 ± 6 minutes more than the formation of a similar anastomosis using the device. In addition, the uneven distribution of the seams relative to each other during its manual formation was noted.

Claims

CLAIM

1. A device for the formation of surgical anastomoses through filaments with two needles at the ends (two-needle filaments), comprising a body in the form of an extended body having end parts made with the possibility of introducing into the lumen of the connected organs; needles located in the end parts of the body, with one needle of each thread located in one end of the body, and the second needle in the opposite; the end parts are provided with needle holes located around the circumference at equidistant distance from each other, and the needles are located in the said end parts so that the blunt end of the needle at the junction with the thread is located closer to the periphery of the end part, and the sharp end is turned to the side the corresponding hole and does not protrude beyond the outer surface of the housing, while the needles are configured to move through the holes of the end parts with the exit of at least part of the needle through the holes I joined for puncture organs.

2. The device according to claim 1, characterized in that the needles are located at an acute angle to the longitudinal axis of the extended body.

3. The device according to claim 1, characterized in that the needles are made straight or with a radius change in curvature.

4. The device according to claim 1, characterized in that for moving and exiting the needles through the openings of the end parts and for providing a puncture of the connected organs, it is equipped with a displacement means located in the end part of the housing and made in the form of a piston with a traction element.

5. The device according to claim 4, characterized in that it is provided with guides for moving the needles through the holes in the end parts of the housing.

6. The device according to claim 4, characterized in that the traction element is made in the form of a cable.

7. The device according to claim 4, characterized in that the traction element is a mechanical linkage system.

8. The device according to claim 4, characterized in that the piston is made with the possibility of "manual" movement or automatic movement, for example, using a spring mechanism associated with the traction element.

9. The device according to claim 1, characterized in that the piston is provided with grooves for accommodating needles.

10. The device according to claim 1, characterized in that it is equipped with means for accommodating loops formed by threads from the corresponding pairs of needles after they are laid in the end parts of an extended body.

1 1. The device according to claim 1, characterized in that it is equipped with a holder for an extended body.

12. The device according to claim 10, characterized in that it is equipped with a holder for an extended body, while the means for placing the loops are located in the holder.

13. The device according to item 12, characterized in that the holder comprises a housing, with a rod located in it, rigidly connected to an extended body in its middle part, while the means for placing the loops is a set of hollow tubes parallel to the rod, and the number tubes selected at least the number of threads used.

14. The device according to claim 1, 1 or 12, characterized in that the holder is equipped with elements for controlling the movement of needles.

15. The device according to claim 1, characterized in that the number of holes on the end of the housing corresponds to the number located in the end of the needles.

16. The device according to claim 1, characterized in that the number of holes on the end of the housing is determined by the inner diameter of the stitched organs.

17. The device according to claim 1, characterized in that the sleeve is used as an extended body, and the end parts of the extended body are made in the form of tips, which can be made integral with the sleeve in the form of a single part, or removable as separate parts.

18. The device according to claim 1, characterized in that the threads are made with markings, for example, color.

19. The device according to claim 1, characterized in that it is equipped with at least one latch (distributor) of threads made with the possibility of fixing the threads after removing the needles from stitched organs.

20. The device according to claim 19, characterized in that the latch (distributor) of the threads is removable.

21. The device according to claim 19, characterized in that the latch (distributor) of the threads consists of a spring with tightly located turns, fixed in the housing, made with compartments for individual threads, providing access to the spring for fixing threads and / or needles between the coils of the spring.

22. The device according to claim 1, characterized in that it is provided with guides for the threads emerging from the holes of the end sections and located on the side of the outer surface of the housing.

23. The device according to p. 22, characterized in that the guides for the threads are made in the form of a ring with slots along its outer contour.

24. The device according to p. 22, characterized in that the guides for the threads are grooves made from the outer surface of the housing.

25. A method of forming surgical anastomoses of hollow and / or tubular organs through threads with two needles at the ends, including

but. the introduction into the lumen of one of the connected hollow organs of the device according to claim 1 with one end part with needles laid in it;

b. the movement of the needles with sharp ends through the openings of the end parts of the device according to claim 1 in the direction from the periphery of the sleeve to its center with the puncture of the walls of one of the connected organs,

d. the movement of the needles with sharp ends through the holes of the second end part of the device according to claim 1 is similar to item b with the puncture of the walls of the second of the connected organs

26. The method according A.25, characterized in that to perform an everted seam additionally after piercing the walls of the organ with needles before removing the needles from the wall of the organ and device, alternately puncture the organ wall closer to its edge with each needle.