RU2258478C1 - Method for applying vascular anastomosis upon artery and device for its implementation named "anchor 15" - Google Patents

Abstract

FIELD: medicine, surgical equipment.

SUBSTANCE: the present innovation deals with the method and the device to form distal anastomoses of autovein with coronary arteries at fulfilling operation on aortocoronary by-pass, applying mammarocoronary anastomoses and anastomoses of other localizations. The device suggested has an endovascular anchor that includes an oval ring with attached ligatures and designed with possibility to be connected with hermetic piston skirt indicated to be connected with autovein. This anchor should be placed inside the vessel so, that its oval ring be in front of vascular inscision to perform traction by ligatures connected with this ring and skirt which automatically gliding along ligatures should be put on the artery by developing hermetic connection. As a result, both the method and the device suggested enables to start by-passing circulation along affected coronary artery about 20-25 min after the onset of operation.

EFFECT: higher efficiency.

9 cl, 3 dwg

Description

The group of inventions relates to medical surgical equipment, and in particular to a method and device intended primarily for applying distal anastomoses with coronary arteries during coronary artery bypass grafting (CABG) operations, applying mammarocoronary anastomoses, as well as anastomoses of other localizations, for example, for applying abdominal anastomoses department of the aorta of the popliteal artery, etc. The device is intended for use mainly when performing operations on a working heart, including with in situations where the rate of application of coronary bypass grafts is of paramount importance (operations performed according to vital indications against cardiogenic shock, unstable angina pectoris, in the first 6 hours after the onset of myocardial infarction, with the development of severe complications arising from intra-aortic balloon angioplasty and stenting of coronary arteries) .

As analogues of the proposed solution, the solutions described in the patents US 6248117, published on 06/19/2001, and US 6701932, published on 03/09/2004.

Unlike standard techniques for performing CABG on a working heart and under conditions of cardiopulmonary bypass (IC), in which blood flow through shunts starts 1.5-2.5 hours after the start of surgery, the proposed device and method allow starting shunt blood flow through the affected coronary arteries 20-25 minutes after the start of surgery.

The proposed device allows you to qualitatively impose anastomoses in an uncomfortable position during the operation, in the basins of the right and envelope of the coronary arteries, where high-quality overlay of anastomoses with existing methods of operations on a working heart is not always possible.

The method and device minimizes the time to stop blood flow through the shunt artery during operations on a working heart, which is important if blood flow to other arteries of the heart is critically difficult due to their damage. Using the proposed device eliminates the seizure of the opposite wall of the anastomosis in the suture, which is possible when applying the anastomosis in an uncomfortable position according to the existing method of operations on a working heart.

The proposed method and device can also be used in classical heart operations in cardiopulmonary bypass, for example, if there is a need to impose an additional shunt after the cardiopulmonary bypass, reassignment under the conditions of IR shunt. The device allows the visiting cardiosurgical team (including those delivered by air by helicopter) to efficiently perform CABG operations in hospitals that do not have cardiac surgery departments, without IR insurance, with the participation of secondary anesthetists. The device can be useful when performing repeated CABG operations, when cardiolysis is difficult and it is possible to isolate only the artery to be bypassed. The cost of the device is not high, an order of magnitude lower than the cost of endovascular stents.

The above advantages of the proposed technical solution for the object "device" are implemented using the following set of features.

A device for applying a vascular anastomosis to an artery contains an endovascular anchor, made with the possibility of connection with a sealing skirt, which is intended for connection with an autogenous. The endovascular anchor is made in the form of a frame element consisting of two rings connected to each other by jumpers. One of these jumpers has a gap with an oval ring fixed in it. It is necessary that the opening of the sealing skirt be made corresponding in shape and size to the oval ring of the frame element. On an oval ring at a distance from one another, fixing threads are fixed for passing through a sealing skirt near its opening.

Jumpers of the frame element in the amount of 4-6 pieces are located in parallel and at the same distance from each other.

The frame element has an even, for example 6-10, number of threads located at the same distance from one another.

The length of each thread is at least 20 cm.

The skirt of the device is made of elastic material and may have a zigzag or wavy edge with radial cuts. The ends of the threads of the frame element can be made integrally with curved needles or can be made with clamps for the reliability of its connection with the skirt (in the embodiment of the device with the armature and the skirt pre-connected to each other).

The above advantages of the proposed technical solution for the object "method" are implemented using the following set of features.

The method of applying a vascular anastomosis to the artery consists in first sampling an autogenous section, then sewing its distal end to the opening edge of the sealing skirt of the above device and passing the fixing threads of the endovascular anchor of the device near the opening edge of the specified skirt. At the same time, a short-term exposure of the shunted artery is carried out and an incision is made in it, after which the indicated anchor is placed inside the artery and by means of traction an oval hole of the anchor opposite the artery incision is placed behind its threads. Then, moving the skirt with the autowave sewn to it along the fixing threads to the anchor of the device, combine the hole in the skirt with the holes in the anchor and in the artery, while special adhesive is preliminarily applied to the entire back surface of the skirt, after which traction and pairwise binding of the threads are performed.

Glue on the back of the skirt is applied to ensure sealing of the resulting compound.

The end of the autovein section, designed to be connected to the edge of the skirt hole, is tapered.

The invention is illustrated by drawings, where in Fig.1 schematically shows an endovascular anchor; figure 2 - sealing skirt; figure 3 is a device for applying a vascular anastomosis assembly.

The device depicted in Fig. 3 can be used both independently and together with stabilizers of the operational field such as “Octopus”, “Starfish”, “Cosmea”, etc. It consists of an endovascular anchor (Fig. 1), a sealing skirt (Fig. .2) and threads fixing them together. The endovascular anchor 1 is made in the form of a hollow wire frame element consisting of longitudinal jumpers (stiffeners) 2 in the amount of 4-6 pieces placed at equal distances from each other and parallel to each other. The ends of the jumpers 2 are connected to two opposite rings 3. In the central part of one of the jumpers an oval ring 4 is formed, along the perimeter of which an even number of threads 5 are fixed at the same distance from each other, having, according to the preferred embodiment of the device, the ends of the needles 6.

The sealing skirt 7 shown in FIG. 2 is made of elastic material and has, as a rule, an uneven, for example, wavy, edge 8 with radial cuts 9. In the center of the skirt, a hole 10 is made, which in shape and size (configuration and area) corresponds to ring 4 endovascular anchor 1. Along the edge of the opening 10 at the same distance from each other, for convenience of use, small marks 11 can be made, designed to pass the ends of the threads 5 through them and fix them, for example, in the form of nodules, including in var ante when the armature 1 and the skirt 7 previously connected to each other.

All materials used in the device are known, tested and approved for use in cardiac surgery.

The frame of the endovascular anchor 1 is made of a metal alloy identical to the alloys used in the production of the endovascular stent, the length of the armature is about 1-1.5 cm, and the inner diameter of the end face of the armature is 1.4-3.0 mm. Skirt 7 can be made of materials used in the manufacture of synthetic vascular prostheses, for example, GORTEX. To connect the anchor 1 and the skirt 7, the standard threads used in cardiac surgery for a vascular suture, for example prolene, are used, at least 20 cm long and with a size of 0-7; 0-8; 0-9 and others

In surgical practice, it is proposed to use a set of the described devices with different sizes (diameter, length) of the anchor part and the skirt, as well as various sizes of the oval hole in the skirt and the corresponding oval ring in the anchor for use in operations on vessels of different diameters and sizes.

A method of applying a vascular anastomosis, for example, in a variant of coronary artery bypass grafting on a working heart using the above-described device, consists in simultaneously performing a procedure for taking a section of a vein from the patient's lower extremity (venous conduit) and median sternotomy (opening of the chest). Then, revision of the vessels of the heart to be bypassed is performed, and the required diameter of the anchor part of the device is determined, while the most significant, “strategic” coronary artery is selected for bypass, after the start of blood flow, the remaining affected arteries are bypassed. The proximal anastomosis is preferably applied using the device described in RU patent for utility model No. 366201. This allows you to impose shunts sequentially, without lateral squeezing of the aorta, alternately letting blood flow through them.

After the patient has taken a portion of autovein 12 (Fig. 3), the distal end 13 cut off at an acute, for example 45 ° angle, is sewn to the edge of the central hole 10 of the skirt 7 using a standard thread used in cardiac surgery. Then the ends of the threads 5 of the anchor are passed through the marks 11 formed in the skirt.

The working heart is dislocated into the wound and the lumen of the artery intended for shunting is opened through an incision. The length of the incision should allow the anchor part of the device to be inserted into the shunt artery. One edge of the anchor is pushed with tweezers into one of the segments of the shunted artery to the maximum depth. The second edge of the anchor is sunk in the artery so that the anchor part of the device is completely in the lumen of the artery.

After this, traction for all the threads produces the orientation of the oval hole 4 of the anchor exactly opposite the section formed in the coronary artery.

A special biological, for example, protein glue from the arsenal approved for use in cardiovascular surgery is applied to the entire area of the back (opposite side with a fixed autogenous) side of the skirt.

Traction is performed simultaneously for all the threads that perform the function of guides in this operation, combining the hole in the skirt with the holes in the anchor and coronary artery, applying the skirt with the autologous sewn to it on the bypass artery, while the skirt lubricated with glue adheres firmly to the artery and the outer surface hearts, after which the threads are connected in pairs. From the foregoing, it follows that the threads in the proposed solution perform a dual function: fixing and guiding.

The proximal end 14 of the autologous 12 is connected to the aorta.

After introduction into the patient’s vessel, the anchor 1 is in it for life and, due to its frame structure, prevents the narrowing of the lumen of the vessel.

The design of the device proposed for the implementation of the method makes it possible to accurately match the distal autologous opening with the opening (lumen) of the shunted artery, which improves the quality of the anastomosis applied, and during the implementation of the method, these holes are close in size and configuration relative to each other, which allows a good comparison the edges of the holes in the autovein with the edges of the holes in the shunt artery. A significant advantage of the proposed method is that it does not require a cessation of blood flow through the shunted artery, and by minimizing the time of dislocation of the heart into the wound, the risk of cardiac arrest, heart rhythm disturbance and the formation of myocardial infarction are significantly reduced.

Claims (9)

1. A device for applying a vascular anastomosis to an artery containing an endovascular anchor made with the possibility of connection with a sealing skirt made of elastic material intended for connection by autowoven suturing, while the endovascular anchor is made in the form of a frame element consisting of two rings connected to each other the other with jumpers, one of which has a gap with an oval ring fixed in it, and the opening of the sealing skirt is made corresponding to the shape and size of the oval ring zu frame member, and an oval ring at a distance from one another by fixed guides fixing threads intended to pass through the sealing skirt near its opening. 2. The device according to claim 1, in which the jumpers of the frame element are parallel and at the same distance from each other. 3. The device according to claim 1, the frame element of which has 4-6 jumpers. 4. The device according to claim 1, the frame element of which has an even number of threads located at the same distance from one another. 5. The device according to claim 4, in which the number of threads of the frame element is 6-10, and the length of each thread is at least 20 cm. 6. The device according to claim 1, the skirt of which has a zigzag or wavy edge with radial cuts. 7. The device according to claim 1, in which the ends of the threads of the frame element are made in one piece with bent needles. 8. The device according to claim 1, in which the ends of the threads of the frame element are made with clips for the reliability of its connection with the skirt. 9. The method of applying a vascular anastomosis to the artery, which consists in the fact that they take a portion of the autovein with subsequent sewing of its distal end to the edge of the opening of the sealing skirt of the device, made according to any one of claims 1 to 8, and passing the fixing threads of the endovascular device anchor near the edge the holes of the skirt, at the same time, expose the shunted artery and perform an incision in it, after which the anchor is placed inside the artery and, by means of traction, the oval hole of the anchor against the cut artery then moving skirt autovein sewn thereto by filaments to the anchor hole in the skirt is combined with holes in the anchor and into the arteries, and the pre-greased adhesive rear surface of the skirt is applied to the artery and produces a pairwise binding yarns.

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