RU170287U1 - DEVICE FOR ATRAUMATIC ANTEGRADIC INTRODUCTION TO THE DOWN AORTA OF THE HYBRID STENT-GRAPH "E-VITA OPEN PLUS" IN HYBRID OPERATIONS ON THE BREAST AORTA - Google Patents

Abstract

A device for atraumatic antegrade insertion of a hybrid stent graft “E-vita open plus” into a descending aorta during hybrid operations on the thoracic aorta. A useful model relates to the field of medical technology, namely to instruments for cardiovascular surgery. A useful model is to develop a device , allowing safe antegrade insertion of a hybrid stent graft “E-vita open plus” into the descending aorta, preventing trauma (tearing, rupture) of the aortic wall by means of a stent graft delivery device. a flat plate of 1 mm thickness made of a deformable inert metal with a total length of 200 mm, consisting of a working part with a width of 20 mm and a length of 150 mm at the distal end and a part designed to hold a metal plate with a width of 10 mm and a length of 50 mm at the proximal end. The device is inserted into the lumen of the descending aorta and a so-called “modeled emphasis” is created for the delivery vehicle of the stent graft “E-vita open plus”. Then, resting against the “simulated emphasis”, the E-vita open plus stent graft delivery system is introduced antegradely into the descending aorta. Thus, the device protects the wall of the descending aorta opposite from the surgeon from injury (tearing, rupture) by the hybrid stent delivery system -graft, as well as create the so-called “simulated emphasis”, due to which it is possible to correctly implant the hybrid stent graft “E-vita open plus” into the aorta.

Description

The utility model relates to the field of medical technology, namely to instruments for cardiovascular surgery.

One-stage hybrid treatment of the thoracic aorta with its various pathologies (aneurysm, stratification) is an alternative to the two-stage method (stage 1 - reconstruction of the aortic arch, stage 2 - reconstruction of the descending aorta). The main advantage of this treatment should be recognized as a reduction in mortality of patients due to the elimination of mortality during the waiting period of the second stage of surgery after reconstruction of the aortic arch. Mortality after simultaneous hybrid treatment is lower than mortality in the sum of two stages of treatment and is 0-18% [1]. Nevertheless, when implanting a hybrid stent-graft “E-vita open plus” into the descending aorta, there is a risk of iatrogenic damage to the aortic wall - its tearing or rupture with the development of life-threatening bleeding. The relevance of the existing problem is not in doubt and to date, attempts to solve it do not fully meet the criteria.

To date, several methods are known to protect the aortic wall from damage by the delivery system when implanting a hybrid stent graft “E-vita open plus” into the descending aorta.

One of the methods is retrograde endovascular insertion of the conductor from the femoral artery, through which the antegrade implantation of the hybrid stent graft “E-vita open plus” is performed [2]. The disadvantages of this method include the lack of objective data confirming the conductor in the true channel (with aortic dissection), it is also possible the formation of a false aneurysm in the zone of vascular access on the thigh. In addition, with a pronounced atherosclerotic change in the abdominal aorta, there is a risk of tearing of the plaque by the conductor with the development of atheroembolism of the distal bed.

To provide additional protection for the aortic wall descending during aortic implantation, the manufacturer of the hybrid stent graft “E-vita open plus” equipped the distal end of the delivery system with a balloon that allows the delivery system to slide along the inner wall of the aorta without additional trauma. However, this design solution does not protect the aortic wall from iatrogenic injury with severe aortic deviation, since it does not allow the delivery system of the hybrid stent graft “E-vita open plus” to be introduced at the required angle.

An adequate prototype of a utility model was not found in the analyzed literature.

The objective of the utility model is to develop a device that allows the safe introduction of an antegrade hybrid stent graft “E-vita open plus” into the descending aorta, preventing trauma (tearing, rupture) of the aortic wall by means of a stent graft delivery.

The problem is solved by the use of the proposed device. The device is a flat plate of deformable metal, consisting of a working part and a part designed to hold the metal plate at the proximal end. The device can be made of any inert ductile metal resistant to antibacterial treatment.

Thus, the device allows you to protect the wall of the descending aorta opposite from the surgeon from trauma (tearing, rupture) by the hybrid stent graft delivery system, as well as create the so-called “simulated stop”, which makes it possible to correctly implant the hybrid stent into the aorta graft "E-vita open plus".

The compact design and the original working part of the hook allows you to adapt the device to the individual anthropometric parameters of the patient, as well as to a specific intraoperative situation.

The essential features characterizing the utility model have shown new properties in the claimed combination that are not explicitly derived from the state of the art in this field and are not obvious to a specialist.

An identical set of properties was not found in the patent and medical literature.

This utility model can be used in practical health care to improve the quality and effectiveness of treatment, and will provide effective and safe implantation of the hybrid stent graft delivery system “E-vita open plus” into the descending aorta.

Based on the foregoing, the present invention meets the conditions of patentability "novelty", "inventive step", "industrial applicability".

The invention will be clear from the following description and the figures attached to it.

In FIG. 1 shows the proposed device, where 1 is a metal plate, 2 is the working part of the metal plate, 3 is the part designed to hold the metal plate.

In FIG. 2 shows a diagram of the application of the proposed device during surgery, where 1 is a metal plate, 2 is the working part of the metal plate, 3 is the part designed to hold the metal plate, 4 is the descending aorta, 5 is the stent-graft “E-vita open plus” .

In FIG. 3 shows a three-dimensional reconstruction of the patient’s thoracic and abdominal aorta with type B aortic dissection (according to Stanford classification) before surgery, where 6 is the proximal fenestration of the true canal, 7 is the deviation of the thoracic aorta.

In FIG. 4 shows a three-dimensional reconstruction of the patient’s thoracic and abdominal aorta with type B aortic dissection (according to Stanford classification) after surgery, where 5 is an E-vita open plus stent graft (installed in the true aortic canal), 7 is the thoracic aortic deviation.

The device (Fig. 1) is a flat plate 1 1 mm thick of wrought metal with a total length of 200 mm, consisting of a working part 2 with a width of 20 mm and a length of 150 mm at the distal end and a part intended to hold a metal plate 3 with a width of 10 mm and 50 mm long at the proximal end.

The proposed device operates as follows (Fig. 2). After preparation of the delivery system of the hybrid stent-graft “E-vita open plus” 4 for implantation in the lumen of the descending aorta 5 (with aortic dissection into the true canal), a metal plate 1 is inserted to a depth of 150 mm (the immersion depth of the metal plate is comparable to the depth of insertion into descending aorta of the delivery system) along the posterior lateral surface of the aortic lumen with a predetermined shape that repeats the course of the descending aorta 5. The assistant holds the metal plate 1 by the part designed to hold 3, preventing I offset it in depth and laterally. The operator starts the delivery system “E-vita open plus” 4 in the descending aorta 5 along the “formed stop” from metal platinum 1 and slides along the working part of the plate 2 to the required level of stent graft installation. Thus, the metered bending of the E-vita open plus 4 delivery system is carried out at the right angle, which avoids both trauma to the aortic wall and damage to the stent graft delivery system with pronounced deviation of the descending aorta. After the final positioning of the E-vita open plus delivery system 4 in the descending aorta 5, the metal plate 1 is removed from the aortic lumen for the part intended to hold 3, taking into account the formed curvature. Then the E-vita open plus delivery system 4 is removed from the descending aorta 5 and the hybrid stent graft is simultaneously opened with its subsequent fixation to the proximal descending aorta 5. Then, the operation is continued according to the standard protocol.

Example.

Patient K., 54 years old, was admitted to the cardiac surgery department with a diagnosis of Subacute dissection of the descending aorta type B according to Stanford classification with retrograde dissection into the aortic arch.

The patient complained of pressure pains behind the sternum with radiation to the left shoulder blade when not admitted due to physical activity.

According to the data of spiral computed aortography with contrast, the stratification of the arch, descending aorta, and abdominal aorta to the level of the iliac arteries with the presence of proximal fenestration behind the mouth of the left subclavian artery was diagnosed. The measured diameters of the ascending aorta and arch of the patient were within the age norm. The measured aortic diameter behind the mouth of the left subclavian artery was 44 mm, at the level of the mitral valve - 43 mm, at the level of the diaphragm - 37 mm, at the level of the celiac trunk - 32 mm. All branches of the aorta departed from the true canal, with the exception of the right doubled renal arteries (Fig. 3). Renal function was preserved (initial urea level was 3.8 mmol / L, blood creatinine - 69 μmol / L, glomerular filtration rate - 122.3 ml / min).

The patient is scheduled for surgical treatment in the amount of thoracic aortic prosthetics in combination with stenting of the descending aorta with a hybrid stent-graft “E-vita open plus” in conditions of cardiopulmonary bypass, pharmacological cold cardioplegia, antegrade unilateral cerebral perfusion, circulatory arrest and moderate hypothermia.

After introductory anesthesia and treatment of the surgical field, a complete longitudinal median sternotomy was performed. The allocation of the aortic arch and its branches, the proximal part of the descending aorta. Artificial blood circulation is connected according to the scheme: brachiocephalic trunk - right atrium. Artificial blood circulation has begun with simultaneous cooling of the patient to a target temperature of 26 ° C. Cardioplegia to the aortic root was performed at the patient's body temperature of 30 ° C. When the target temperature is reached, circulatory arrest with antegrade unilateral cerebral perfusion of the brain through the brachiocephalic trunk is started. The lumen of the aortic arch was opened to the level of the mouth of the left subclavian artery. During revision of the descending aorta, the false channel is located on the posterior lateral surface of the aorta, occupies 2/3 of the circumference of the descending aorta.

The implantation of the delivery system, followed by the opening of the stent graft, was carried out using the technology described above. The operation completed as standard. The duration of cardiopulmonary bypass was 200 minutes, the aortic clamping time was 65 minutes, and the circulatory arrest time was 45 minutes. The patient was transferred to the intensive care unit.

12 hours after the end of the operation, the patient regained consciousness, is available for contact, fulfills simple requests. Neurological status without focal symptoms from the brain and spinal cord. The patient was on mechanical ventilation for 99 hours. The total time the patient spent in the intensive care unit was 12 days. According to spiral computed aortography with contrast in the postoperative period, a stent graft is implanted in the descending aorta to the level of the 8th thoracic vertebra. During the stent graft, the false channel is thrombosed. Lamination remains distal to the implanted stent graft without increasing the diameter of the abdominal aorta (Fig. 4). The patient was discharged from the hospital in satisfactory condition on the 31st day after the operation.

The device was used in 15 patients with aortic dissection type A and B according to the Stanford classification. Preparation for surgery and anesthetic management were the same in all patients.

All patients had access to the aorta through median sternotomy, the operation was performed under cardiopulmonary bypass and cardioplegia with Custodiol solution, moderate hypothermia (25–28 ° C), and circulatory arrest with unilateral antegrade cerebral perfusion. The device was used after opening the lumen of the aortic arch under conditions of circulatory arrest with antegrade cerebral perfusion.

The application of the device proposed as a utility model made it possible to ensure the effective and safe introduction of the delivery system of the hybrid stent graft “E-vita open plus” into the descending aorta.

Bibliography

1. Tian DH, Wan B, Di Eusanio M, Black D, Yan TD. A systematic review and meta-analysis on the safety and efficacy of the frozen elephant trunk technique in aortic arch surgery. Ann Cardiothorac Surg 2013; 2 (5): 581-591.

2. Di Bartolomeo R, Di Marco L, Armaro A, Marsilli D. Alessandro Leone, Emanuele Pilato, Davide Pacini. Treatment of complex disease of the thoracic aorta: the frozen elephant trunk technique with the E-vita open prosthesis. European Journal of Cardio-thoracic Surgery 35 (2009) 671-676.

Claims (1)

Device for atraumatic antegrade insertion of the hybrid stent graft “E-vita open plus” into the descending aorta during hybrid operations on the thoracic aorta, which is a flat plate 1 mm thick of a deformable inert metal with a total length of 200 mm, consisting of a working part with a width of 20 mm and 150 mm long at the distal end and a part intended to hold a metal plate 10 mm wide and 50 mm long at the proximal end.

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