RU2764867C1 - Method for aortic arch prosthesis for damaged brachiocephal arteries, synthetic vascular aortic arch prosthesis for its implementation and method of its manufacture - Google Patents

Abstract

FIELD: medicine; medical technology.

SUBSTANCE: inventions group relates to medicine and medical technology, namely to cardiovascular surgery. In case of hypothermia at 26°C and stopping the systemic IC, the damaged aortic arch is dissected. The mouth of the left subclavian artery is cut off and clamped. A distal anastomosis is formed with the descending part of the thoracic aorta by installing the distal part of the vascular prosthesis of the aortic arch inside the descending part of the thoracic aorta. After that, the "skirt" -cuff is sewn to the descending part of the thoracic aorta, then the systemic IR is restored through the additional branch of the aortic arch prosthesis. A clamp is applied to the proximal part of the arch prosthesis. An anastomosis is formed between the third branch of the trifurcation prosthesis and the left subclavian artery. An intervascular anastomosis is formed between the prostheses of the ascending part and the aortic arch. The main branch of the aortic arch prosthesis is clamped and, after the prevention of air embolism, cardiac activity is restored. On the beating heart, an end-to-end intervascular anastomosis is formed between the main jaws of the trifurcation prosthesis and the main jaws of the aortic arch prosthesis. After stabilization of hemodynamics, IC is completed. The specified method is implemented by means of a synthetic vascular prosthesis of the aortic arch, which includes a main branch, an additional perfusion branch and a "skirt" -cuff. The specified prosthesis is made by fixing a woven knitted cuff in the form of a flat ring to a linear vascular prosthesis of the aortic arch. Then an additional branch of the aortic arch prosthesis is formed by suturing a vascular synthetic prosthesis with a diameter of 8 mm to a linear vascular aortic arch prosthesis with a "skirt" -cuff. After that, the main branch of the aortic arch prosthesis is formed, for which the linear vascular prosthesis is sutured at an angle to the linear vascular aortic arch prosthesis with a "skirt" cuff and an additional branch. Then a multilayer coating is applied to the surface of the product, where the first layer is a layer of protein, the second is a layer of anticoagulant - heparin, the third is a layer of a biodegradable coating based on gelatin and drugs with antimicrobial and antiplatelet action, while glutaraldehyde is used as a crosslinking agent, and plasticizer - glycerin, then the resulting prosthesis is sterilized with ethylene oxide at 37°C.

EFFECT: inventions group makes it possible to preserve cerebral, cardiac and visceral blood flow at the stage of end-to-end intervascular anastomosis between the main branch of the aortic arch prosthesis and trifurcation prosthesis on the beating heart in patients with dissection of the ascending part and the aortic arch.

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Description

SUBSTANCE: group of inventions relates to medicine and medical equipment and can be used in surgical correction of type A aortic dissection with damage to the branches of the aortic arch with the need for prosthesis of the brachiocephalic arteries, the ascending aorta and the aortic arch.

Currently, when performing combined operations on the brachiocephalic arteries, the ascending aorta and the arch, in most cases for complex forms of aortic dissection, three groups of synthetic prostheses are used. The first includes synthetic prostheses of the ascending aorta and the root of the aorta, the second - synthetic prostheses of the aortic arch, the third - synthetic vascular prostheses used for prosthetics of the brachiocephalic arteries. The combination of prostheses from these three groups allows us to solve the set surgical problem. However, intraoperatively it is necessary to anastomose (connect) all three prostheses into a single complex - ascending aorta-arch-brachiocephalic arteries - by stitching together. Areas of intervascular anastomoses are one of the most frequent sources of bleeding after completion of cardiopulmonary bypass (EC) and require additional surgical hemostasis, which increases the risk of intraoperative infection and postoperative complications. Moreover, intervascular anastomoses of the ascending aortic arch prostheses are usually placed end-to-end, while the trifurcation prosthesis from the brachiocephalic arteries is implanted end-to-side into the ascending aortic or arch prosthesis. End-to-side implantation requires a lateral pressed prosthesis of the ascending aorta, and therefore it is extremely difficult to achieve intraoperative tightness of this anastomosis, which increases the risk of bleeding. It is possible to perform an end-to-side anastomosis between the trifurcation prosthesis and the ascending aortic prosthesis on a stopped heart and a completely clamped aorta, but this increases the time of myocardial ischemia and the need for additional cardioplegia.

Taking into account the above requirements and shortcomings of the accepted methods, a synthetic aortic arch vascular prosthesis was developed, which has a main branch implanted end-to-side at the stage of prosthesis creation, equipped with an additional branch to ensure perfusion and a "skirt" cuff to facilitate the formation and tightness of the distal anastomosis with the aortic arch, the angles of the connection of the branches in the prosthesis and their location are determined at the stage of the preoperative examination of the patient by the methods of radiation diagnostics (ultrasound, MSCT, MRI).

As a prototype, gelweave aortic arch prostheses were chosen - woven vessel prostheses made of polyester fiber, having a patented impregnation with modified animal gelatin and heparin, which gives multibranch vascular prostheses zero surgical porosity, and a material thickness of 0.4 mm brings it closer to the thickness of its own tissue [1 ]. To impart thromboresistant and antimicrobial properties, heparin, silver acetate, and triclosan are added to the coating of Gelweave linear vascular prostheses for peripheral arteries.

These aortic arch prostheses have one additional branch designed for perfusion and/or a “skirt” cuff for the formation of a distal anastomosis with an aortic arch and/or relatively small diameter branches (10 mm) for prosthetics of the brachiocephalic arteries, but do not have an additional branch for anastomosing with a trifurcation prosthesis from the brachiocephalic arteries.

The technique described by S.D. Galvin [2]. The paper presents the technique of prosthesis of the aortic arch with a multi-branch prosthesis Thoraflex, implantation of a three-branch prosthesis from the brachiocephalic arteries into one of the branches of the prosthesis of the aortic arch with the imposition of an end-to-end intervascular anastomosis. However, with this technique, the remaining branches were plugged and not used. Moreover, the branch of the prosthesis used for anastomosis with a prosthesis from the brachiocephalic arteries has a relatively small diameter (10-12 mm), which subsequently can cause a circulatory deficit in the brachiocephalic blood supply pools on both sides. As a prototype of the method for prosthetics of brachiocephalic arteries, the technique of prosthetics with a trifurcation prosthesis was chosen [3, 4].

To determine the diameter of the constituent parts of the three-branches prosthesis and prosthesis of the aortic arch, the technique used by Qingsheng Lu for the reconstruction of the aortic arch and brachiocephalic arteries was chosen as a prototype. In the described technique, the diameter of the grafts of the aortic arch and its branches is selected based on measurements of vessel diameters on computed tomography images with 3D reconstruction [5]. However, in this study, the technique was used for endovascular replacement of the aortic arch and brachiocephalic arteries.

The following methods were chosen as a prototype of a method for processing a vascular prosthesis to impart antimicrobial, antithrombogenic properties and zero surgical porosity:

1. The prosthesis is preserved with a 0.625% aqueous solution of glutaraldehyde. Immediately before use, it is treated with a solution of heparin and arginine with a ratio of components: heparin 50-150 units / ml and arginine 0.5-1.5 mg / ml. The treatment is carried out for 8-12 hours at a temperature of 20-25°C and pH 7.0-7.4.

2. A sterile vascular prosthesis is immersed in a saturated solution of an alcohol-soluble antibiotic. The exposure period is 24-72 hours. Next, the prosthesis is removed from the solution, the alcohol evaporates for 3 minutes, then it is treated with a 1% solution of the Sulfacrylate glue.

The technical problems to be solved in the present invention are: increasing the efficiency of complex surgical treatment of patients with type A aortic dissection in combination with damage to the brachiocephalic arteries, the ability to form an end-to-end sealed anastomosis between a trifurcation vascular prosthesis and aortic arch prosthesis on a "working heart" without pressing arch prosthesis or ascending aorta.

The technical result of the group of inventions consists in maintaining cerebral blood flow at the stage of formation of an end-to-end anastomosis between the trifurcation prosthesis and the aortic arch prosthesis, restoring full blood supply through the brachiocephalic arteries in patients with damaged brachiocephalic arteries during aortic dissection and is confirmed by clinical examples.

These aspects of the technical result are achieved due to the following sets of essential features:

I. A method of surgical treatment of type A aortic dissection with damage to the brachiocephalic arteries using a synthetic aortic arch prosthesis with a main branch to form an end-to-end anastomosis with a prosthesis of the brachiocephalic arteries, an additional perfusion branch and a "skirt" cuff to form a distal anastomosis with a descending thoracic aorta: the ascending aorta and arch, brachiocephalic trunk, left common carotid artery, left subclavian artery are surgically isolated; carry out the cannulation of the left axillary artery, perform a phased cutting off of the branches of the aortic arch; a three-branched vascular prosthesis is implanted with the formation of vascular anastomoses of two branches of the aortic arch with branches of a three-branched prosthesis, starting from the brachiocephalic trunk, then the left common carotid artery, the main branch of the trifurcation prosthesis is clamped with a clamp, cerebral perfusion is provided by temporary shunting from the basin of the left axillary artery or artificial blood supply; IR is connected at hypothermia of 26°C through the left axillary artery and vena cava with blood supply to the brain through the complex: right axillary artery-three-branched vascular prosthesis; perform prosthetics of the ascending aorta; at hypothermia of 26°C and stop of systemic EC, the damaged aortic arch is dissected, the orifice of the left subclavian artery is cut off and clamped, a distal anastomosis is formed with the descending thoracic aorta by placing the distal part of the vascular prosthesis of the arch inside the descending thoracic aorta and suturing the “skirt”-cuff to descending thoracic aorta, restore systemic EC through an additional branch of the prosthesis of the aortic arch, applying a clamp to the proximal part of the prosthesis of the arch, form an anastomosis between the third branch of the trifurcation prosthesis and the left subclavian artery, form an intervascular anastomosis between the prostheses of the ascending aorta and the aortic arch; the main branch of the aortic arch prosthesis is clamped and, after the prevention of air embolism, cardiac activity is restored, an end-to-end intervascular anastomosis is formed on the beating heart between the main branch of the trifurcation prosthesis and the main branch of the aortic arch prosthesis, after stabilization of hemodynamics, EC is completed.

II. Synthetic vascular prosthesis of the aortic arch consists of a main prosthesis of large diameter, a main branch for forming end-to-end anastomosis with a prosthesis of brachiocephalic arteries, an additional perfusion branch, a “skirt” cuff for forming a distal anastomosis with the descending thoracic aorta.

In special cases of this prosthesis, the diameters of vascular prostheses are determined on the basis of anatomical data obtained using contrast-enhanced computed tomography; the formed synthetic vascular prosthesis of the arc is treated with a drug, which is used as an anticoagulant - heparin; the formed synthetic vascular prosthesis of the arch is treated with drugs, which are used as two antigregants - acetylsalicylic acid and chimes; the formed synthetic vascular prosthesis of the arch is treated with drugs, which are used as two antimicrobial drugs - metronidazole and ciprofloxacin.

III. A method for manufacturing a synthetic aortic arch prosthesis with a main branch, an additional perfusion branch and a "skirt" cuff: two synthetic linear prostheses of small diameters and a synthetic cuff are sewn to a synthetic vascular prosthesis of a larger diameter; previously, based on the anatomy of the brachiocephalic arteries and the aortic arch of the patient, the diameters of the branches of the trifurcation prosthesis, the diameter of the main branch of the aortic arch prosthesis, the diameter of the base of the aortic arch prosthesis are determined; a woven knitted cuff in the form of a flat ring is sewn to the middle of the base of the prosthesis of the aortic arch, using an atraumatic braided polyester suture material and a double twisted return suture (when returning, the needle enters the existing holes), the cuff is applied on both sides in places of its tight contact with the outer wall corrugated vascular prosthesis; at a distance of 20 mm from the cuff, a hole with a diameter of 7 mm is formed and a linear vascular prosthesis with a diameter of 8 mm is sutured at a right angle, end-to-side, forming an additional branch using an atraumatic braided polyester suture material with two types of sutures: the first row of sutures is a continuous return P -shaped seam (when returning, the needle enters the existing holes), while the edges of the holes of both prostheses turn outwards, and a second row of seams is applied over this row - this is a continuous return stitch (when returning, the needle falls into the existing holes); at a distance of 20 mm from the additional branch of the prosthesis of the aortic arch, moving counterclockwise by 1/3 of the circumference of the prosthesis of the aortic arch, a hole is cut out with a diameter of 1 mm less than the main branch of the proposed trifurcation vascular prosthesis (14, 16 or 18 mm) and sutured according to the type of end to the side a linear vascular prosthesis 30 mm long of the corresponding diameter at an angle of 60 ° to the arc prosthesis in the direction of the “skirt”-cuff with an atraumatic braided polyester suture material with two types of sutures: a continuous return U-shaped suture (in this case, the edges of the holes of both prostheses turn outward) and continuous return stitch (when returning, the needle enters the existing holes); check the patency and tightness using a flexible video endoscope; a multilayer coating is applied to the surface of the product, where the first layer is a layer of protein, the second is a layer of heparin anticoagulant, the third is a layer of biodegradable coating based on gelatin and antimicrobial and antiplatelet drugs, while glutaraldehyde is used as a crosslinking agent, and as a plasticizer - glycerin, then the resulting prosthesis is sterilized with ethylene oxide at 37°C.

In particular cases of this method, the diameters of the vascular prostheses and the angle of departure of the main branch from the arch prosthesis are determined on the basis of the anatomical dimensions obtained using contrast-enhanced computed tomography; a coating is applied to the surface of the formed prosthesis of the aortic arch - while as the first layer - albumin protein from an aqueous solution with a concentration sufficient to obtain adsorbed albumin in the amount of 3 × 10 ^-4 g / g of the prosthesis, as the second layer - heparin from an aqueous solution with concentration of 100 IU / ml of solution, as the third layer - gelatin from an aqueous solution in the amount of 0.07 g / g of the prosthesis, metronidazole in the amount of 0.26 mg / g of the prosthesis and ciprofloxacin 0.16 mg / g of the prosthesis are used as antimicrobials , as antiplatelet drugs - acetylsalicylic acid 0.4 mg / g of the prosthesis and curantyl 0.15 mg / g of the prosthesis, as a crosslinking agent - glutaraldehyde in the ratio by weight of gelatin to glutaraldehyde as 12: 1, and as a plasticizer - glycerin in an amount of 30% by weight of gelatin.

The essence of the developed group of inventions includes:

1. A method of surgical treatment of type A aortic dissection with the need for prosthetics of the brachiocephalic arteries and arch;

2. A method for manufacturing a synthetic aortic arch prosthesis with a main branch for forming an end-to-end anastomosis with a trifurcation prosthesis of brachiocephalic arteries, an additional perfusion branch and a “skirt” cuff for forming a distal anastomosis with the descending thoracic aorta.

3. The possibility of manufacturing a special prosthesis of the aortic arch of various sizes with different diameters of the main branch, taking into account the diameter of the descending thoracic aorta and the diameter of the prosthesis of the brachiocephalic arteries, individually for a particular patient;

4. Formation on the surface of the product of a specially designed multifunctional multilayer coating applied to a synthetic prosthesis of the aortic arch, in order to give the product a set of necessary functional properties that provide increased biological safety: thromboresistance (resistance to thrombosis), antimicrobial (resistance to infection), zero surgical porosity (minimization of blood loss in the intra- and postoperative period).

The proposed method for the surgical treatment of type A aortic dissection with damage to the ascending aorta, the aortic arch of the brachiocephalic arteries is expressed in a set of essential features, includes the surgical isolation of the ascending aorta and the aortic arch, the brachiocephalic trunk, the left common carotid artery, the left subclavian artery, cannulation of the left axillary artery, cannulation right axillary, performing a phased cutting off of the branches of the aortic arch and the formation of vascular anastomoses with the branches of the three-branch prosthesis with a polypropylene thread 5-12, starting from the brachiocephalic trunk, then the left common carotid artery, the main branch of the trifurcation prosthesis is clamped with a clamp, cerebral perfusion is provided by temporary shunting from the basin of the left axillary artery or artificial blood supply, then EC is started against the background of hypothermia 26°C through the left axillary artery and vena cava, while the blood supply to the brain is carried out through the right axillary artery and sutured th three-branched vascular prosthesis, prosthesis of the ascending aorta is performed, with hypothermia of 26°C and systemic EC is stopped, the damaged aortic arch is dissected, the orifice of the left subclavian artery is cut off and clamped, a distal anastomosis is formed with the descending thoracic aorta by placing the distal part of the vascular prosthesis of the arch inside the descending section of the thoracic aorta and suturing the “skirt”-cuff to the descending thoracic aorta with a continuous twisting suture with a 4-22 polypropylene thread, restore systemic EC through an additional branch of the aortic arch prosthesis, applying a clamp to the proximal part of the arch prosthesis, form an anastomosis between the third branch of the trifurcation prosthesis and the left subclavian artery, form an intervascular anastomosis between the prostheses of the ascending aorta and the aortic arch, pinch the main branch of the prosthesis of the aortic arch and, after the prevention of air embolism, restore cardiac activity, form an intervascular anastomosis of the k type on the beating heart. End to end between the main branch of the trifurcation prosthesis and the main branch of the prosthesis of the aortic arch, after stabilization of hemodynamics, EC is completed.

The specified sequence of actions allows the first stage to perform prosthetics of the brachiocephalic trunk and the left common carotid artery, thereby creating conditions for ensuring safe perfusion of the brain through the branches of the three-branches prosthesis. Next, the stage of intervention is performed on the ascending aorta and the aortic arch to eliminate the dissection in these departments. The fundamental point is the next stage - the prosthesis of the left subclavian artery and the formation of an anastomosis with the third branch of the three-branched prosthesis, which allows perfusion of the brain through the complex: the right axillary artery-trifurcation prosthesis, and after the formation of an intervascular anastomosis between the prostheses of the ascending aorta and the aortic arch, restore cardiac activity and on the beating heart, perform the formation of an anastomosis between the main branch of the arc prosthesis and the trifurcation prosthesis.

A method for manufacturing a synthetic aortic arch prosthesis with a main branch for forming an end-to-end anastomosis with a prosthesis of brachiocephalic arteries, an additional perfusion branch and a “skirt” cuff for forming a distal anastomosis with the descending thoracic aorta, including the choice of the diameter of vascular prostheses and the area for formation lateral holes and angles of discharge when sewing vascular "branches" for the main and additional branches. At the stage of preoperative examination of the patient, according to the results of the analysis of the anatomy and dimensions of the ascending section, aortic arch, brachiocephalic arteries, the dimensions of the components of the prosthesis are determined. To form the above prosthesis, the arcs are used: a knitted cuff and three textile vascular prostheses - one linear larger diameter and two linear small diameters. The method consists in fixing to a linear vascular prosthesis (larger diameter) a woven knitted cuff in the form of a flat ring, the inner diameter of which is equal to the outer diameter of the vascular prosthesis, and the outer diameter is 65 mm, using an atraumatic braided polyester 5/0 suture material and a double twisting return suture (when returning, the needle enters the existing holes) impose on both sides of the cuff in places of its tight contact with the outer wall of the corrugated vascular prosthesis. The cuff is placed at a distance of 30 mm from the edge of the prosthesis. At a distance of 20 mm from the cuff (in the direction of the formation of the branches), a hole with a diameter of 7 mm is cut out and an additional vascular synthetic prosthesis with a diameter of 8 mm is sutured, forming an additional branch, at a right angle, end-to-side, with atraumatic braided polyester suture material 5/0 with two types of sutures : the first row of sutures is a continuous return U-shaped suture (when returning, the needle enters the existing holes), while the edges of the holes of both prostheses turn outward, and a second row of sutures is applied over this row - this is a continuous return twist suture (when the needle returns falls into existing holes). At a distance of 20 mm from the additional branch of the prosthesis of the aortic arch, moving counterclockwise by 1/3 of the circumference of the prosthesis of the aortic arch, a hole is cut out with a diameter of 1 mm less than the main branch of the proposed trifurcation vascular prosthesis (14, 16 or 18 mm) and sutured according to the type " end-to-side" linear vascular prosthesis 30 mm long of the corresponding diameter at an angle of 60 ° to the arch prosthesis in the direction of the "skirt"-cuff with atraumatic braided polyester 5/0 suture material with two types of sutures: the first row of sutures is a continuous return U-shaped suture ( when returning, the needle enters the existing holes), while the edges of the holes of both prostheses turn outward, and a second row of stitches is applied over this row - this is a continuous return stitch (when returning, the needle falls into the existing holes). Patency and tightness are checked by video broadcast using a flexible short-focus, waterproof video endoscope with a fourfold magnification, a viewing angle of 700 and a resolution of 1280 × 720, 30 frames per second.

The proposed method for manufacturing a synthetic arch prosthesis makes it possible to obtain a prosthesis of complex configuration with anatomy and dimensions appropriate for a particular patient.

In order to give a synthetic prosthesis an aortic arch with a main branch to form an end-to-end anastomosis with a prosthesis of brachiocephalic arteries, an additional perfusion branch and a "skirt" cuff to form a distal anastomosis with the descending thoracic aorta of a complex of necessary biological properties: thromboresistance, antimicrobial, zero surgical porosity after the formation of the prosthesis structure is completed, a multilayer coating is applied to the surface of the product, where the first layer is a layer of protein, the second is a layer of heparin anticoagulant, the third is a layer of a biodegradable coating based on gelatin and antimicrobial and antiaggregant drugs, while using as a crosslinking agent glutaraldehyde, and as a plasticizer - glycerin, then the resulting prosthesis is sterilized with ethylene oxide at 37°C.

The prosthesis of the aortic arch is first treated with an aqueous solution of albumin with an albumin concentration in the amount of 3×10 ^-4 g/g of the prosthesis, washing and drying are performed. Next, the prosthesis is treated with an aqueous solution of heparin with a concentration of 100 IU/ml solution. Drying. Then the third layer is applied - an aqueous solution of gelatin with an amount of 0.07 g / g of the prosthesis, metronidazole in the amount of 0.26 mg / g of the prosthesis and ciprofloxacin 0.16 mg / g of the prosthesis, acetylsalicylic acid 0.4 mg / g of the prosthesis are used as antimicrobials. g of the prosthesis and curantyl 0.15 mg/g of the prosthesis, glutaraldehyde is used as a crosslinking agent in the ratio by weight of gelatin to glutaraldehyde as 12: 1, and glycerol is used as a plasticizer in an amount of 30% by weight of gelatin. Drying.

After specific processing, the prosthesis is checked for tightness (water permeability, expressed in ml / cm ² / min), thromboresistance by the amount of heparin immobilized in the sample (at least 75 μg / g of the sample), antimicrobial disk-diffusion method in accordance with MUK 4.2.1890 -04. Sterilization treatment of the finished coated prosthesis is carried out by the method of gas sterilization with ethylene oxide at 37°C.

The essence of the group of inventions is illustrated in the diagrams, where the descending thoracic aorta is measured and the size of the main prosthesis of the aortic arch is selected on cross sections of computed tomography with contrasting of the ascending aorta, aortic arch and brachiocephalic arteries. In cases of the descending thoracic aorta without dissection, the diameter of the main prosthesis is determined by the corresponding diameter of the descending aorta, immediately after the origin of the left subclavian artery, in the area of the proposed distal anastomosis. The size of the main prosthesis of the aortic arch in case of aortic dissection is determined based on the calculation of the size of the true lumen, immediately after the origin of the left subclavian artery, in the area of the proposed distal anastomosis. On computed tomography on a transverse section, the length of the contour of the true lumen is measured, the resulting value is the length (L) of the circumference of the true lumen of the aorta and allows you to calculate the diameter (D) of the circle (L=π*D). The diameter of the main arch prosthesis is chosen 2 mm less than the diameter of the resulting true lumen. The size of the main branch of the aortic arch prosthesis is chosen in accordance with the trifurcation prosthesis intended for prosthetics of the brachiocephalic arteries: 14/8/7/7 mm or 16/10/8/8 mm. The choice of a trifurcation vascular prosthesis is also based on measuring the diameters of the brachiocephalic arteries in the area of their intended replacement. The main branch of the trifurcation vascular prosthesis can be 14 or 16 mm.

After the formation of the prosthesis of the aortic arch, containing the main and additional branches and the "skirt"-cuff, a specially designed multifunctional multilayer coating is applied to the product in order to give the product a set of necessary functional properties that provide increased biological safety: thromboresistance, antimicrobial properties, zero surgical porosity.

After prosthetics of the brachiocephalic arteries, the ascending section and the aortic arch, clamps are applied to the main branches of the trifurcation prosthesis and the aortic arch prosthesis and an end-to-end anastomosis is formed. In this case, cerebral perfusion is carried out through the right axillary artery, systemic - through an additional branch of the aortic arch prosthesis. Thus, there is no need for parietal pressing of the aortic and arch prostheses for implantation of the trifurcation prosthesis in the ascending section, the end-to-end anastomosis of vascular prostheses of the same diameter has greater tightness compared to the end-to-side anastomosis, and the formation of the anastomosis is carried out on the "working heart ”, which reduces the time of cardioplegia.

Thus, the proposed group of inventions makes it possible to radically eliminate dissection in damaged brachiocephalic arteries with a trifurcation prosthesis, dissection in the ascending section with a linear vascular prosthesis, dissection in the aortic arch with a specially designed prosthesis, ensure adequate blood flow at all stages of the formation of vascular anastomoses, Form an intervascular anastomosis between a trifurcation prosthesis and an end-to-end arc prosthesis on a beating heart with perfusion of the head, heart and visceral organs, reduce the risk of life-threatening complications (thrombosis, infection, blood loss), thanks to an optimally designed prosthesis individually for a particular patient and its special processing with a developed multifunctional biodegradable coating .

The achievement of a technical result in the implementation of the proposed method of aortic arch prosthesis for damaged brachiocephalic arteries, a synthetic vascular aortic arch prosthesis for its implementation and a method for its manufacture is confirmed by the following example:

Example 1. Based on an objective examination (the presence of a clinical picture of chronic aortic dissection, diastolic murmur over the aorta), ultrasound examination (expansion of the ascending aorta up to 50 mm, aortic arch up to 45 mm, aortic valve insufficiency III stage, the presence of additional floating echo- signal in the ascending aorta and arch), computed tomography data with contrasting of the entire aorta and brachiocephalic arteries (aortic dissection from the fibrous ring of the aortic valve to the level of the aortic bifurcation with spread to the brachiocephalic trunk with separation of the orifice of the left subclavian artery), patient K., 36 years old , diagnosed with chronic aortic dissection type A with spread to the brachiocephalic trunk, rupture of the orifice of the left subclavian artery, aortic valve insufficiency grade III. According to the obtained anatomical picture, according to CT data, the diameter of the true lumen of the descending thoracic aorta was 22 mm, the diameter of the brachiocephalic trunk was 8 mm, the diameter of the left common carotid and left subclavian arteries in the area of the proposed anastomoses was 7 mm. Using the above methods, a synthetic aortic arch prosthesis was developed - the main linear arch prosthesis was 20 mm in diameter, a synthetic prosthesis with dimensions of 14/8/7/7 mm was determined as a trifurcation prosthesis for the brachiocephalic arteries, thus, the main branch of the aortic arch prosthesis was 14 mm . To create a synthetic prosthesis of the aortic arch, a woven linear vascular prosthesis with a diameter of 20 mm was used for the base of the prosthesis, a “skirt”-cuff in the form of a ring with an inner diameter of 20 mm, an outer diameter of 65 mm, a woven linear vascular prosthesis with a diameter of 8 mm for an additional perfusion branch, woven linear vascular prosthesis with a diameter of 14 mm for the main branch. After the formation of the prosthesis design, quality control of the anastomoses, application of a bioactive multilayer coating on the surface of the product proposed by the authors, based on a polyelectrolyte complex of protein-anticoagulant-antiplatelet agent and a biodegradable coating based on gelatin in order to impart thromboresistance, antimicrobial properties, zero surgical porosity and sterilization, the prosthesis was implanted. according to the proposed method.

Cerebral oximetry is a non-invasive method for assessing regional oxygenation of the brain, reflecting the presence of blood flow in the brain and the supply of oxygen to the brain [6]. At all stages of the operation, the presence of blood flow through the arteries of the brain is monitored by constant cerebral oximetry using the INVOS device with two sensors located above the right and left hemispheres of the brain. Preservation of cerebral blood flow at all stages of the operation is confirmed by persistent cerebral oximetry of more than 40%.

Preservation of cerebral blood flow at all stages of the operation is confirmed by cerebral oximetry data. Figure 1 shows oximetry data for 12 hours in patient K. with prosthetic aorta, brachiocephalic trunk, left common carotid and subclavian arteries according to the above method using a new aortic arch prosthesis. In figure 1, the abscissa shows the time, where one interval corresponds to 30 minutes, the ordinate shows blood oxygen saturation (from 0 to 100%): oximetry trends for the left and right hemispheres of the brain, respectively. Throughout the entire period of surgical intervention, no decrease in the level of cerebral oximetry below 40% was detected, which indicates the preservation of adequate cerebral blood flow (Fig. 1).

After the operation, control Doppler ultrasound revealed complete patency of the prostheses, unchanged blood flow in the common carotid arteries. The figure 2 shows the data of Doppler ultrasound of the patient K.: unchanged blood flow in the left common carotid artery distal to the level of the anastomosis, which indicates the complete patency of the vascular prosthesis (Fig. 2).

To assess the patency of vascular prostheses: ascending aortic prosthesis, aortic arch prosthesis, trifurcation vascular prosthesis, computed tomography with contrast enhancement of the thoracic aorta and brachiocephalic arteries was performed. The figure 3 shows postoperative data of computed tomography with contrast and 3D reconstruction of the patient K., revealed full contrast of all vascular prostheses, the area of vascular anastomoses with brachiocephalic arteries (1), the anastomosis area of the main branch of the aortic arch prosthesis and the main branch of the trifurcation prosthesis (2) , brachiocephalic arteries distal to the anastomoses, indicating complete patency of the prostheses and adequate blood supply to the brain (figure 3).

Literature

1. Ukpabi P., Marois Y., King M, Deng X., Martin L., Laroche G., Douville Y., Guidoin R. The gelweave polyester arterial prosthesis. Can. J. Surg. 1995; 38(4): 322-31.

2. Galvin S.D., Perera N.K., Matalanis G. Surgical management of acute type A aortic dissection: branch-first arch replacement with total aortic repair. Ann. Cardiothorac. Surg. 2016; 5(3): 236^14. DOI: 10.21037/acs.2016.05.11.

3. V. A. Mironenko, S. V. Garmanov, N. P. Bakuleva, and Yu. Surgical treatment of a patient with type I aortic dissection complicated by cerebral malperfusion using a trifurcation vascular prosthesis. Thoracic and cardiovascular surgery. 2020; 62(1):57-61. DOI: 10.24022/0236-2791-2020-62-1-57-61.

4. Matalanis G., Sean D., Galvin S.D. "Branch-first" continuous perfusion aortic arch replacement and its role in intra-operative cerebral protection. Ann. Cardiothorac. Surg. 2013; 2 (2): 194-201 DOI: 10.3978/j.issn.2225-319X.2013.02.01.

5. Qingsheng Lu, Jiaxuan Feng, Jian Zhou et al. Endovascular repair by customized branched stent-graft: A promising treatment for chronic aortic dissection involving the arch branches. J. Thorac. Cardiovasc. Surg. 2015; 150(6): 1631-8.e5.DOI: 10.1016/j.jtcvs.2015.08.032.

6. Krylov B.V. Neuroreanimatology: a practical guide. M.: GEOTAR-Media, 2017.

Claims (7)

1. A method for the surgical treatment of type A aortic dissection with damage to the brachiocephalic arteries by using a synthetic aortic arch prosthesis having a "skirt" cuff, a perfusion branch and a main branch, including surgical isolation of the ascending aorta and aortic arch, brachiocephalic trunk, left common carotid artery, left subclavian artery; cannulation of the left axillary artery; cannulation of the right axillary artery; at the same time, a phased cutting off of the branches of the aortic arch is performed and vascular anastomoses are formed with branches of a three-branch prosthesis, a clamp is applied to the main branch of the trifurcation prosthesis; provide cerebral perfusion; connect artificial circulation (EC) against the background of hypothermia 26°C; perform prosthetics of the ascending aorta; prosthesis of the aortic arch, characterized in that, with hypothermia of 26°C and stop of the systemic EC, the damaged aortic arch is dissected, the orifice of the left subclavian artery is cut off and clamped, a distal anastomosis is formed with the descending thoracic aorta by installing the distal part of the vascular prosthesis of the aortic arch according to claim 2 , made by the method according to claim 6, inside the descending thoracic aorta, after which the “skirt”-cuff is sutured to the descending thoracic aorta, then the systemic EC is restored through an additional branch of the aortic arch prosthesis, a clamp is applied to the proximal part of the arch prosthesis, an anastomosis is formed between the third branch of the trifurcation prosthesis and the left subclavian artery, form an intervascular anastomosis between the prostheses of the ascending aorta and the aortic arch, clamp the main branch of the prosthesis of the aortic arch and, after the prevention of air embolism, restore cardiac activity; with the new branch of the trifurcation prosthesis and the main branch of the prosthesis of the aortic arch, after stabilization of hemodynamics, EC is completed. 2. Synthetic vascular prosthesis of the aortic arch, manufactured by the method according to p. 6, including the main branch, additional perfusion branch and "skirt" cuff. 3. Synthetic vascular prosthesis of the aortic arch according to claim 2, characterized in that the diameters of the vascular prostheses are determined on the basis of anatomical data on the diameter of the descending thoracic aorta, brachiocephalic arteries, obtained on the basis of contrast-enhanced computed tomography. 4. Synthetic vascular prosthesis of the aortic arch according to claim 2, characterized in that it is treated with drugs - an anticoagulant - heparin and antiplatelet agents - acetylsalicylic acid and chimes. 5. Synthetic vascular prosthesis of the aortic arch according to claim 2, characterized in that it is treated with drugs, which use antimicrobial drugs - metronidazole and ciprofloxacin. 6. A method for manufacturing a synthetic aortic arch prosthesis according to claim 2, including fixing a woven knitted cuff in the form of a flat ring to a linear vascular prosthesis of the aortic arch by applying a double twisted return suture, which is formed by returning the needle to existing holes, the suture is applied on both sides cuffs in the places of its contact with the outer wall of the vascular prosthesis of the aortic arch, forming a "skirt"-cuff; then an additional branch of the aortic arch prosthesis is formed by suturing a vascular synthetic prosthesis with a diameter of 8 mm to a linear vascular prosthesis of the aortic arch with a “skirt”-cuff, after which the main branch of the aortic arch prosthesis is formed, for which the linear vascular prosthesis is sutured at an angle to the linear vascular prosthesis aortic arches with a “skirt”-cuff and an additional branch, while suturing is performed with two types of sutures: the first row of sutures is a continuous return U-shaped suture: when returning, the needle enters the existing holes, then the edges of both prostheses turn outward and over the first a second row of sutures is applied - a continuous return twisting suture, in which, when returning, the needle enters the existing holes, then the patency and tightness are checked using a flexible video endoscope, a multi-layer coating is applied to the surface of the product, where the first layer is a layer of protein, the second is a layer anticoagulant - heparin, the third - a layer of biodegradi gelatin-based coating and drugs of antimicrobial and antiplatelet action, while glutaraldehyde is used as a crosslinking agent, and glycerol is used as a plasticizer, then the resulting prosthesis is sterilized with ethylene oxide at 37°C. 7. The method according to p. 6, characterized in that a coating is applied to the surface of the formed prosthesis of the aortic arch, while an aqueous solution of albumin with a concentration of 3x10 ^-4 g/g of the prosthesis is used as the first protein layer, and water is used as the second layer heparin solution with a concentration of 100 IU / ml of solution, as the third layer - an aqueous solution of gelatin with an amount of 0.07 g / g of the prosthesis, metronidazole in the amount of 0.26 mg / g of the prosthesis and ciprofloxacin 0.16 mg / g are used as antimicrobial drugs. g of the prosthesis, as antiplatelet agents - acetylsalicylic acid 0.4 mg/g of the prosthesis and curantyl 0.15 mg/g of the prosthesis, glutaraldehyde is used as a crosslinking agent in the ratio of gelatin to glutaraldehyde by weight as 12:1, and as a plasticizer - glycerin in the amount of 30% by weight of gelatin.

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