RU2720745C1 - Combined hybrid prosthesis with seamless connections for open surgical interventions in splitting aneurysms of thoracic aorta and method for implantation thereof - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, namely to cardiovascular surgery, and can be used for surgical treatment of stratifying aneurysms of thoracic aorta in conditions of artificial circulation. Hybrid prosthetic of the thoracic aorta consists of the main element including the self-opening stent-graft of the descending thoracic aorta and the stentless prosthetic aortic prosthesis connected to it with the perfusion branch, and auxiliary elements - at least one self-opening brachiocephalic stent-graft installed in the arched zone of the prosthesis. Austere prosthetic of the aortic arch comprises an implantation branch. Installed brachiocephalic stent-graft contains in the proximal portion a segment for seamless connection with a prosthetic aortic prosthesis consisting of a number of closed cells. Proximal portion of each cell of the segment is bent outward at angle of 80–90° relative to the central axis of the brachiocephalic stent-graft. Proximal portion of the segment for a seamless joint is coated from the inside with a tissue membrane fixed to the cells. Arc joints for securing the haemostatic gasket are made at joints of segment cells for seamless connection. Disclosed is a hybrid implant implantation method.

EFFECT: technical result is facilitating intraoperative manipulations of the surgeon and reducing the length of the operation.

10 cl, 9 dwg

Description

The invention relates to medicine, namely to cardiovascular surgery, and can be used for the surgical treatment of dissecting thoracic aortic aneurysms in cardiopulmonary bypass.

Endovascular and hybrid methods of treatment of aortic dissection are increasingly being introduced into the practice of modern cardiovascular surgery. These methods reduce the morbidity and duration of the operation, which naturally leads to a decrease in mortality and improves long-term results of operations in this category of patients at extremely high risk.

When DeBakey type I aortic dissection, the pathological process of dissection is characterized by great anatomical variability, extending either to all of the areas listed below, or to some of them in various combinations:

- aortic root;

- ascending aorta and arch;

- descending thoracic aorta;

- mouths and distal parts of one, two or three brachiocephalic arteries.

In the surgical treatment of this pathology, the hybrid aortic prosthetics technique, known as the “frozen elephant trunk,” has proven itself well. The technique involves simultaneous prosthetics of the descending thoracic aorta with a stent graft, and the ascending aorta and arches with a tubular synthetic prosthesis connected to the stent graft. If necessary, prosthetics of the brachiocephalic arteries are performed using tubular synthetic prostheses and various types of plastic manipulations on the aortic root.

Three types of hybrid prostheses are known in clinical practice: E-Vita Open Plus (Jotech Inc., https://www.jotec.com/en/products/thoracic-stent-grafts/e-vita-open-plus.html), Thoraflex Hybrid (Vascutek, www.vascutek.com/products/thoraflex-hybrid/) and J Graft Open (Japan Lifeline, Tokyo, Japan, (https://www.japanlifeline.com/the/the_3_2.html).

The advantage of the J Graft Open prosthesis is its high flexibility without losing the shape of the lumen, which is achieved due to the thin cobweb-shaped frame made of two-wire nitinol wire, as well as a convenient and easy-to-use delivery system that provides the surgeon with simplicity and speed of manipulation., The main disadvantage is the location of the frame on the inside the surface of the stent graft, which can cause thrombosis in the prosthesis even in conditions of intense blood flow in the aorta. In addition, this prosthesis contains only two parts: a stent graft placed in the descending aorta and a corrugated synthetic arch prosthesis. It lacks a sealing cuff at the junction of these two parts, as well as branches for prosthetics of the brachiocephalic arteries. In this regard, if it is necessary to intervene on these vessels, the surgeon has to apply 2 rows of anastomoses: both the proximal one with the prosthesis and the distal one with the undamaged part of the brachiocephalic vessel, after cutting off its stratified proximal part. If necessary, prosthetics of 3 vessels, this drawback significantly increases the duration of the operation as a whole, and the duration of cerebral ischemia.

The E-Vita Open Plus hybrid prosthesis contains a stent graft on a self-expanding outer frame of open-type nitinol wire cells, a sealing cuff and an arc tubular prosthesis. The latter is screwed into the stent graft and in this form the prosthesis is packed into the delivery system. After an aortotomy, a stent graft is installed, in which the nitinol cells open to their predetermined diameter, after which the prosthesis of the arch is “turned” out of the lumen of the descending artery channel formed by the stent graft and is joined by surgical methods to the aortic root, forming a structure replacing the ascending aorta and its arc.

The disadvantage of the prosthesis E-Vita Open Plus is also the lack of its branches for prosthetics of brachiocephalic vessels.

A hybrid prosthesis is known from the prior art that contains a special branch in the stent-graft part, which allows the stent-graft to be installed in the left subclavian artery (US 2013/166015 A1, 06/27/2013). Its disadvantage is the possibility of prosthetics only for this artery, while if necessary, intervention on the left common carotid or bracheocephalic stem has to perform traditional surgical procedures. In addition, in the absence of pathology of the left subclavian artery, the use of this prosthesis is impractical due to the presence of an additional hole in the arch zone.

A technical solution is known that allows seamless joining of stent grafts intended for branches of the main vessel with a stent graft of the main vessel (US 2013166010 A1, June 27, 2013). This is achieved through the use of a number of cells in the proximal part of the stent-graft branch, each of which in its proximal part due to ballooning of a special configuration forms an outward angle with respect to the central axis of the stent-graft branch. The disadvantage of this solution is the need to use a special balloon system and the technical complexity of the implementation.

Known combined, consisting of two parts of a stent graft for prosthesis of the thoracic aorta by the endovascular method (WO 2014/163957 A1, 10/09/2014). First of all, the distal part is installed, containing two holes; through the proximal opening of this part, a stent graft of the left common carotid artery is established. Then, the proximal part of the stent graft of the arch is installed, containing one hole through which the stent graft of the brachiocephalic trunk is installed. Lastly, a stent graft of the left subclavian artery is installed through the distal opening of the distal part of the arc graft. The disadvantage of this solution is, firstly, that it is suitable only for the endovascular method, and, secondly, due to the presence of holes it is not applicable in the absence of pathology in any (or all) brachiocephalic arteries.

The closest is the technical solution implemented in the Thoraflex Hybrid hybrid prosthesis (www.vascutek.com/products/thoraflex-hybrid/), which includes 3 brachiocephalic and perfusion branches. This reduces the duration of the operation when performing prosthetics of the braphiocephalic arteries, and also makes it possible to reduce the duration of ischemia in various arterial pools by controlling perfusion through a cannula inserted into the perfusion branch, varying the position of the clamp compressing the aorta. The disadvantage of the Thoraflex Hybrid prosthesis is the extremely complicated delivery system of the stent graft of the descending aorta, since the presence of 4 additional branches in the stentless part of the prosthesis does not allow it to be placed inside the stent graft in the delivery system. In addition, in the absence of the need for prosthetics of the brachiocephalic arteries, the surgeon is forced to cut off additional jaws and spend additional time sealing them, which in the conditions of aortic blood flow requires utmost care.

The proposed solution is intended for “open” (using cardiopulmonary bypass) surgical interventions for dissecting the thoracic aortic aneurysm with the aim of prosthetics.

The technical result of the proposed invention is the creation of a combined hybrid thoracic aorta prosthesis for "open" surgical interventions for dissecting thoracic aortic aneurysms, consisting of the main element and auxiliary - from 1 to 3 brachiocephalic stent grafts, each of which is installed in the arch zone of the prosthesis only if necessary its use, and is connected seamlessly with the main element, which facilitates the standardization of the surgeon’s intraoperative manipulations and the sealing of prosthetic joints, and also significantly reduces the duration of the operation.

The proposed hybrid prosthesis includes a main tubular element consisting of a self-expanding stent graft placed in the descending thoracic aorta and connected with it using sutures with a corrugated-free prosthetic aortic arch prosthesis and a sealing cuff. The stentless prosthesis of the aortic arch contains 2 branches: perfusion and additional - implantation. The self-expanding stent graft of the descending thoracic aorta is made of tissue material with a metal frame sewn on the outside, which is a separate sinusoidal or Z-shaped stent element. The auxiliary element is at least one self-expanding stent-graft of the brachiocephalic artery installed in the area of the arch of the prosthesis, connecting seamlessly with the main element of the prosthesis. A hybrid prosthesis may include 1 to 3 installed brachiocephalic stent grafts. Stent grafts of the brachiocephalic arteries are made of tissue material with a metal frame sewn on the outside. The frame is a separate stent elements of open cells, sinusoidal or zigzag in shape, located at a distance of 5-10 mm from each other. Each brachiocephalic stent-graft contains a segment in the proximal part for seamless connection with a prosthetic prosthesis of the aortic arch. This segment consists of closed cells, while the proximal part of each cell is curved outward at an angle of 80-90 ° relative to the central axis of the cells. The proximal portion of the segment for seamless joining is internally coated with a tissue membrane. At the joints of the closed cells, arcuate fastenings are made, bent outward, designed to fix the hemostatic strip on the outer surface of the connection of the brachiocephalic stent graft with the prosthesis of the aortic arch.

During implantation of a hybrid prosthesis and prosthetics of the brachiocephalic arteries, an incision is made in the area of the prosthesis-free prosthesis of the aortic arch, which is equal in diameter to the prosthetic artery. Next, incision isolation of the prosthetic brachiocephalic artery is performed and a delivery system with a brachiocephalic stent graft is introduced into the brachiocephalic artery through the implantation jaw and an incision in the prosthesis of the aortic arch. The brachiocephalic stent graft is gradually released until the proximal part of the segment is fully opened for seamless connection inside the prosthesis of the aortic arch. On the outer surface of the junction of the stent graft with the prosthesis of the aortic arch, a hemostatic pad is fixed, clamped by arched mounts. This operation is repeated from 1 to 3 times - depending on the number of brachiocephalic arteries that have undergone dissection and need prosthetics.

The invention is illustrated by drawings, which depict:

FIG. 1 - combined hybrid prosthesis fully equipped

FIG. 2 - brachiocephalic stent graft

FIG. 3 - the proximal part of the self-expanding brachiocephalic stent graft in the fixation zone (A - incomplete disclosure; B - full disclosure; C - after fixation of the hemostatic pad)

FIG. 4 - Implantation of the main element (A - aortotomy, isolation of the brachiocephalic arteries and insertion of the delivery system into the descending aorta; B - opening of the stent graft of the descending aorta and the release of the stentless prosthesis of the aortic arch)

FIG. 5 - Implantation of brachiocephalic stent grafts: A - into the left subclavian artery, B - into the left common carotid artery, C - into the brachiocephalic trunk.

FIG. 6 - The final stage of manipulation on the aorta

The combined hybrid thoracic aortic prosthesis consists of the main element 1 and the auxiliary element - brachiocephalic stent grafts 2 (Fig. 1). The main element of the hybrid thoracic aortic prosthesis 1 consists of two parts: a tubular self-expanding stent graft of the descending thoracic aorta and a tubeless corrugated aortic arch prosthesis 4 of the tubular shape with two branches: perfusion (5) and implantation (6). A self-expanding stent-graft 3 is formed of a tubular prosthesis and external open cells 7 fixed to it, made of superelastic material and arranged spirally with respect to the longitudinal axis of the prosthesis; in this case, the spiral can be formed by both open and closed turns. The end rows 8 of the stent graft 3 are made of cells located horizontally with respect to the central axis of the stent graft. A tubeless prosthesis 4 is fixed to the stent graft 3 and contains a sealing sleeve 9.

Each brachiocephalic stent graft 2 (Fig. 2 and 3) with a diameter of 8-12 mm consists of a tissue tube and individual concentric stent elements. Stent elements are represented by open cells of type 10 and are located along the entire length of the stent graft horizontally with respect to the longitudinal axis at a distance of 5-10 mm in height between each two stent elements. In the proximal part, the stent graft 2 contains a segment for seamless connection with the main element of the hybrid prosthesis, consisting of cells of the closed type 11 and arcuate fastenings 13. Moreover, the proximal part of each closed cell 11 is located at an angle of 80-90 ° to the distal part of this cell and covered from the inside with a membrane 12 made of synthetic fabric and fixed with seams to the proximal part of the cells. At the junctions of the closed cells 11 there are arcuate fastenings 13 directed by the ends outward of the outer surface of the stent graft and designed to hold the hemostatic strip 14 on the outer part of the seamless connection with the tubeless prosthesis.

To implant a hybrid prosthesis, the surgeon after thoracotomy performs a complete transverse aortotomy 15 above the aortic root 16 and at the level of the aortic isthmus 17. Relieves the false channel 18 from clots and blood clots, the brachiocephalic artery is excised with an “island” 19 (Fig. 4A). After that, the delivery system 21 with the main element of the hybrid prosthesis 22 is inserted into the true channel 20 of the descending aorta and gradually releases the stent graft of the descending aorta 3 (Fig. 4B). After the stent graft 3 is fully opened, it turns out the stent-graft tubeless part 4 with additional jaws 5 and 6, stitches the sealing cuff 9 to the edge of the aneurysmal bag 23. Cannula the perfusion jaw 5 (Fig. 5A), applies clamp 24 to the stentless prosthesis arc 4, after which the supply of oxygenated blood begins on line 25 from the heart-lung machine. Then proceeds to manipulate the brachiocephalic arteries.

Example 1. If it is necessary to prosthetize all three brachiocephalic arteries, makes a cruciate incision 26 on the prosthesis of the aortic arch, corresponding to the projection of the mouth of the left subclavian artery 27, and cuts off the prosthetic artery from the common “islet” by incision 28. Through the implantation junction 6 and incision 26 introduces a delivery system with brachiocephalic stent graft 29 in the left subclavian artery. After releasing from the delivery system all the rows of open cells 10, except for the proximal closed type 11, the assistant fixes a hemostatic pad 14 along the circumference of the stent graft, which, when the proximal cells 11 are released, is clamped between the arcuate fastenings 13, the proximal part of the proximal cells 11 and the prosthesis tissue arcs 4 (Fig. 3B). After the stent graft 2 is opened and secured in the lumen of the main prosthesis, the delaminated adventitia of the brachiocephalic artery is fixed to the sealing pad with suture 30. After that, it repeats the same procedure with the left carotid artery 31 (Fig. 5B), while the clamp 24 moves in such a way as to ensure perfusion of the left subclavian artery. Lastly, a stent graft is implanted into the common brachiocephalic trunk 32 (Fig. 5B). After implantation of stent grafts into all target arteries, the implantation jaw 6 is stitched, ligated and cut off, the clamp is transferred to the aortic prosthesis proximal to the brachiocephalic arteries and a tubular prosthesis 4 is connected with suture 33 to the aortic root 16 (Fig. 6).

Example 2. If necessary, prosthetics of the left subclavian and left carotid arteries, the surgeon makes a cruciform incision 26 on the prosthesis of the aortic arch, corresponding to the projection of the mouth of the left subclavian artery 27, and cuts off the prosthetic artery from the common “islet” by section 28. Through the implantation jaw 6, a delivery system with brachiocephalic stent graft 29 in the left subclavian artery. After releasing from the delivery system all rows of cells 10, except proximal 11, the assistant fixes a hemostatic pad 14 along the circumference of the stent graft 2, which, when the proximal cells 11 are released, is clamped between the arcuate mounts 13, the proximal part of the proximal cells 11 and the prosthesis tissue of the arch 4. After the stent graft 2 is opened and secured in the lumen of the main prosthesis, the exfoliated adventitia of the brachiocephalic artery is fixed to the sealing pad with suture 30. After this, the same manipulation with the left carotid artery 31 is repeated, while the clamp 24 is moved in such a way as to ensure perfusion of the left subclavian artery. After this, the mouth of the undamaged brachiocephalic trunk is reimplanted into the shaftless prosthesis of arch 4, the implantation branch 6 is stitched, ligated and cut off, the clamp is placed on the aortic prosthesis proximal to the brachiocephalic arteries and connects the tubular prosthesis 4 to the aortic root 16 with suture 33.

Example 3. If necessary, prosthetics of the left subclavian artery (27) and brachiocephalic trunk (32) require a stent graft 2 to be inserted first into the left subclavian artery, then into the brachiocephalic trunk. The reimplantation of the mouth of the left carotid artery (31) into the prosthesis of the aortic arch 4 is performed last.

Example 4. If it is necessary to prosthetize one of the three brachiocephalic arteries, a stent graft 2 is first implanted through the implantation jaw 5, then the intact arteries are reimplanted into the prosthesis of the aortic arch 4. If the left subclavian artery (27) or the brachiocephalic stem (32) is prosthetized, the two remaining intact arteries can be reimplanted into the prosthesis of the arc 4 “islet” (with a small portion of the patient’s aorta). If a stent graft 2 is implanted in the left carotid artery (31), then the mouth of the brachiocephalic trunk and the left subclavian artery are reimplanted into the prosthesis of the arc 4 separately.

Claims (10)

1. A hybrid thoracic aortic prosthesis, consisting of a main element including a self-expanding stent graft of the descending thoracic aorta and a stentless prosthesis of the aortic arch with a perfusion jaw connected to it and auxiliary elements - at least one self-expanding brachiocephalic stent-placed prosthesis graft, characterized in that the stentless prosthesis of the aortic arch contains an implantation jaw; the installed brachiocephalic stent graft contains in the proximal part a segment for seamless connection with the prosthesisless prosthesis of the aortic arch, consisting of a number of closed cells, the proximal part of each cell of the segment is curved outward at an angle of 80-90 ° relative to the central axis of the brachiocephalic stent graft, proximal a portion of the seamless joint segment is internally coated with a tissue membrane fixed to the cells; at the junction of the cells of the segment for seamless connection, arcuate fastenings are made to fix the hemostatic strip. 2. A hybrid prosthesis according to claim 1, characterized in that it may include from 1 to 3 installed brachiocephalic stent grafts. 3. The hybrid prosthesis according to claim 1, characterized in that the segment for seamless connection is sewn to the brachiocephalic stent graft tissue material from the outside. 4. The hybrid prosthesis according to claim 1, characterized in that the brachiocephalic stent graft is made of tissue material in the form of a tube with a metal frame sewn on the outside. 5. The hybrid prosthesis according to claim 4, characterized in that the metal frame of the brachiocephalic stent graft is a separate stent elements. 6. The hybrid prosthesis according to claim 1, characterized in that the self-expanding stent graft of the descending thoracic aorta is made of tissue material with a metal frame sewn on the outside. 7. The hybrid prosthesis according to claim 6, characterized in that the skeleton of a self-expanding stent graft of the descending thoracic aorta is a separate stent elements. 8. The hybrid prosthesis according to claim 1, characterized in that the stentless prosthesis of the aortic arch contains a sealing cuff. 9. The method of implantation of the hybrid prosthesis described in paragraph 1, with stratifying aneurysm of the thoracic aorta and brachiocephalic arteries, including a complete transverse aortotomy above the aortic root and at the level of the aortic isthmus, cutting off the brachiocephalic arteries, introducing the delivery system into the true channel of the descending aorta, release -Graft of the descending aorta, turning the stent-graft of the tubeless tubular part with additional branches out of the lumen of the stent graft, sewing the sealing cuff to the edge of the aneurysmal sac, cannulation of the perfusion branch, clamping on the stentless prosthesis of the arch, connecting to the cardiopulmonary bypass device, which differs, performed by incision on a stentless prosthesis of the aortic arch, incisional isolation of the prosthetic brachiocephalic artery, insertion into the brachiocephalic artery through the implantation jaw, and incision in the prosthesis of the aortic arch prosthesis with a brachiocephalic stent graft, its gradual this release until the proximal part of the segment is fully disclosed for seamless connection inside the prosthesis of the aortic arch, fixation on the external surface of the connection of the stent graft with the prosthesis of the aortic arch of the hemostatic pad, clamped by arcuate fastenings. 10. The implantation method according to claim 9, characterized in that after implantation of the brachiocephalic stent graft, the implantation jaw is flashed, ligated and cut off.

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