RU219504U1 - Multi-branched hybrid prosthesis for reconstruction of the thoracoabdominal aorta - Google Patents

Abstract

The utility model relates to medicine, namely to cardiovascular surgery, and can be used for open prosthetics of the thoracoabdominal aorta under conditions of continuous perfusion of the visceral arteries. Multi-branch hybrid prosthesis for reconstruction of the thoracoabdominal aorta, has a main and four additional branches made of dacron. At the ends of the main branch of the prosthesis, there are self-expanding circular stent elements that allow connection with a blood vessel in a seamless manner under conditions of continuous blood perfusion of the visceral organs, for which additional branches are made with the possibility of fixing the balloon catheter with a suture. The technical result of the proposed device is the creation of a multibranched hybrid prosthesis for the reconstruction of the thoracoabdominal aorta.

Description

The utility model relates to medicine, namely to cardiovascular surgery, and can be used for open prosthetics of the thoracoabdominal aorta (TAOA) under conditions of continuous perfusion of visceral arteries.

Despite significant advances in preoperative assessment and perioperative care, mortality associated with open TAOA reconstruction has not changed significantly. Thus, according to the literature, morbidity and mortality in open repair of TAOA aneurysms is 30-50% and 4-20%, respectively (Lars G Svensson et al. Prospective randomized neurocognitive and S-100 study of hypothermic circulatory arrest, retrograde brain perfusion, and antegrade brain perfusion for aortic arch operations, The Annals of Thoracic Surgery, Volume 71, Issue 6, 2001, Pages 1905-1912). Ischemia of the internal organs is the main factor determining the risk of postoperative complications (Joseph S. Coselli et al. Mortality and paraplegia after thoracoabdominal aortic aneurysm repair: a risk factor analysis, The Annals of Thoracic Surgery, Volume 69, Issue 2, 2000, Pages 409 -414). According to Frankel W.C. et al., in a retrospective review of a 30-year experience of open TAOA preconstruction, gastrointestinal complications developed in 5.9% of cases (Frankel W.C. et al. Early gastrointestinal complications after open thoracoabdominal aortic aneurysm repair // The Annals of Thoracic Surgery. - 2021. - T. 112. - No. 3. - S. 717-724). Endovascular and hybrid approaches are an alternative strategy for patients in whom open reconstruction carries a prohibitive risk. However, these technologies also have their drawbacks. The frequency of mesenteric ischemia after endovascular TAOA reconstruction is 1-5% (King R. W. et al. Occlusion of the celiac artery during endovascular thoracoabdominal aortic aneurysm repair is associated with increased perioperative morbidity and mortality // Annals of vascular surgery. - 2020. - T. 66. - S. 200-211).

According to Moulakakis K.G. et al., the incidence of mesenteric ischemia after hybrid treatment of TAOA was 5% (Moulakakis K. G. et al. Combined open and endovascular treatment of thoracoabdominal aortic pathologies: a systematic review and meta-analysis // Annals of Cardiothoracic Surgery. - 2012. - T. 1. - No. 3. - S. 267-276), at the same time, according to a meta-analysis conducted by Rosset E. et al. the incidence of postoperative mesenteric ischemia reached 14-21% depending on the center (Rosset E. et al. Editor's choice-hybrid treatment of thoracic, thoracoabdominal, and abdominal aortic aneurysms: a multicenter retrospective study // European Journal of Vascular and Endovascular Surgery. - 2014. - T. 47. - No. 5. - S. 470-478). Therefore, the development of techniques and devices to reduce the period of visceral ischemia during open TAOA reconstruction is an urgent problem in modern aortic aneurysm surgery (Nicholas T. Kouchoukos et al. Early Outcomes After Thoracoabdominal Aortic Aneurysm Repair With Hypothermic Circulatory Arrest, The Annals of Thoracic Surgery , Volume 108, Issue 5, 2019, Pages 1338-1343).

From the existing level of technology, several models of prostheses are known that are used to reconstruct sections of the vascular bed, in the case of aortic aneurysms, however, their use requires a long manual formation of anastomoses, which is associated with the development of a number of life-threatening ischemic complications.

GORE® Hybrid Vascular Graft, Gore&Associates, Inc., USA (https://www.goremedical.com/products/hybrid). The GORE® Hybrid Vascular Graft is a linear vascular prosthesis from polytetrafluoroethylene (ePTFE), which includes a self-expanding stent element made of nitinol, which makes it possible to form an anastomosis in a seamless way with one of the ends of the sutured vessels. is retained in the lumen of the vessel due to radial expansion forces, while the size of the graft is selected taking into account 10% over-size.The Hybrid Vascular Graft prosthesis has been proven to facilitate and accelerate the implementation of complex and multi-stage aortic reconstructions by reducing the time of formation of distal fistulas, however, this product has a number shortcomings, the main of which is the lack of a full-fledged size range, which makes it possible to manipulate blood vessels with a diameter of 4.8 to 8.5 mm.

The closest to the claimed technical solution is the Gelsoft™ Coselli prosthesis (Terumo, Australia Pty Limited) (https://www.terumo.com.au/healthcare-professionals/cardiothoracic-and-vascular-grafts) - the only direct analogue intended for TAOA prosthetics. This prosthesis contains four branches for prosthetics of the visceral arteries. Branches leading to the celiac trunk, superior mesenteric artery and paired renal arteries have a diameter of 8 mm and a length of 10 cm. The prosthesis has a size range with a diameter of 20 mm to 30 mm in 2 mm increments and the length of the main branch of the prosthesis is 60 cm. The implantation of the prosthesis is carried out using a manual surgical suture.

The technical result of the proposed device is the creation of a multibranched hybrid prosthesis for the reconstruction of the thoracoabdominal aorta under conditions of continuous blood perfusion of the visceral arteries. The technical result of the proposed device is achieved by connecting the prosthesis through self-expanding circular stent elements, as well as a manual surgical suture, while perfusion of the visceral branches is carried out using balloon catheters passed through additional branches.

The essence of the invention is illustrated by drawings, which show:

Fig. 1 - general view of a multibranched hybrid prosthesis;

Fig. 2 is a cross-sectional view of a multibranched hybrid prosthesis;

Fig. 3 - view of the additional branch during visceral perfusion.

A multi-branch hybrid prosthesis for reconstruction of the thoracoabdominal aorta has a main branch (1) and four additional branches (2-5) made of Dacron (Fig. 1, 2). At the ends of the main branch of the prosthesis (1) there are self-expanding circular stent elements (6) of Z-shape, made of nitinol and fixed to the wall of the main branch (1) with technological sutures (Fig. 1, 2). At the same time, the self-expanding circular stent elements are coated with a hemocompatible coating, for example, a silicon-carbon film (aC:H:SiO _x ) doped with titanium, and the fixation of each self-expanding circular stent element with technological sutures allows modeling the length of the main branch, based on the individual characteristics of the patient's anatomy. . In the central part of the main branch (1) there are four additional branches (2-5), (2) for prosthetics of the celiac trunk, (3) superior mesenteric artery, (4) right renal and (5) left renal arteries, respectively. Moreover, the branch (5), intended for the left renal artery, originates two centimeters below the branch (4) (Fig. 2). Also, the free end of the additional branches (2-5) is made with the possibility of fixing the balloon catheter (7) with a seam (8) to the wall of the additional branches (Fig. 1, 3).

The implantation of the prosthesis is performed according to the generally accepted method of TAOA prosthetics, while before the reimplantation of additional branches, a balloon catheter is installed through the technological hole into the lumen of the reconstructed artery, with the help of which continuous blood perfusion of the internal organs is performed. After the reconstruction of the visceral arteries is completed, the balloon is deflated and the balloon catheter is removed, and the technological hole is closed with a suture. The essence of the technique of implantation of the main branch of the prosthesis is as follows: after cooling in saline (0-4°C), self-expanding circular stent elements are compressed all the way towards the central axis and placed in the lumen of the blood vessel, then warmed with warm (36-40°C). C) physiological saline. After self-expansion of the circular stent elements, the anastomosis can be further strengthened with a ligature.

Claims (2)

1. Multi-branch hybrid prosthesis for reconstruction of the thoracoabdominal aorta, having a main and four additional branches made of Dacron, characterized in that at the ends of the main branch of the prosthesis there are self-expanding circular Z-shaped stent elements made of nitinol, coated with a hemocompatible coating and fixed to the wall of the main branch with the help of technological seams, while the free end of each additional branch is made with the possibility of fixing the balloon catheter with the help of a seam to the wall of the additional branch. 2. Multibranch hybrid prosthesis for reconstruction of the thoracoabdominal aorta according to claim 1, characterized in that the self-expanding circular stent elements are covered with a silicon-carbon film (aC:H:SiO _x ) doped with titanium.