AORTIC GRAFT CLAMPING CONNECTOR
TECHNICAL FIELD
The invention relates to a device designed to ensure the continuity of blood flow by enabling the connection of the aorta and an artificial graft using a clamp mechanism, in cases where an aneurysm (vessel dilation) and/or dissection (tearing of the layers forming the vessel wall) develops in any section of the aorta, and where the damaged aortic tissue is to be replaced with an artificial vessel.
BACKGROUND
The aorta is the main artery that originates from the heart and supplies blood to the tissues in the human body. Its normal diameter ranges between 2.5 and 3.5 cm. In the event of an aneurysm (vessel dilation) and/or dissection (tearing of the layers forming the vessel wall) occurring in any section of the aorta, the patient's life may be at risk, and replacement of the damaged aortic tissue with an artificial graft may become necessary. This replacement is typically performed using polypropylene sutures of various sizes, depending on the anatomy of the vessel. However, such a procedure may lead to an increased anastomosis time (the time taken to suture the vessels together), may cause damage to the vessel due to the sutures, and/or may result in bleeding due to mismatch between the vessel and the graft.
In the known state of the art, during the replacement of damaged aortic tissue using an artificial graft, approximately 10-15 cm of the ascending aorta (the main arterial segment emerging from the heart) is exposed, and the damaged portion measuring about 5-10 cm is excised and replaced with an artificial graft. This procedure is performed using sutures (surgical threads with semicircular needles) of varying thickness, selected according to the diameter of the vessel. One end of the graft is attached to the aortic tissue close to the heart (proximal section), and the other end is connected to the section farther from the heart (distal section). While these procedures can be performed easily and quickly in small vessel injuries, in cases involving major vessels and requiring cardiac arrest, the operations take longer and carry a higher risk of bleeding. Moreover, since the proximal and distal diameters of the graft are identical, it becomes difficult to achieve an optimal match when there is a size mismatch with the native vessels, further increasing the risk of bleeding. In patent application US20020107535, a study regarding aortic vessel connection is presented. In the mentioned application, there is a potential risk of damage to the aortic tissue due to the inability to adjust the force applied during the ligation (compression phase), which poses a threat to the viability of the aortic tissue. In this section, due to the compression applied (which may lead to tissue necrosis from impaired perfusion), there is a potential risk of aortic rupture and subsequent separation of the anastomosis or development of aortic dissection from this point. Moreover, performing the anastomosis using a thick-walled material may result in greater trauma (hemolysis) to the blood cells. This condition, referred to as hemolysis, can lead to various pathologies. Therefore, as a solution to these possible problems, a porous device has been designed in our invention to maintain the perfusion of the aortic tissue through the blood flowing within.
AIM OF THE INVENTION
The aim of our invention is to enable anastomosis to be performed at a total of four connection points, two proximally and two distally.
Another aim of the invention is to ensure a safer and more comfortable anastomosis by increasing the low trauma resistance of the unhealthy aortic tissue designated for anastomosis.
Another aim of the invention is to reduce the duration of the anastomosis procedure and to facilitate the surgical technique.
Another aim of the invention is to reduce possible postoperative complications. Another aim of the invention is to minimize potential diameter mismatches.
Another aim of our invention is to minimize this risk by ensuring that the diameters of the aorta and the graft forming the anastomosis are kept as close as possible.
Another aim of our invention is to objectively measure the wall thickness and diameter of the aorta in order to improve compatibility between the graft and the aorta.
FIGURE LIST
Figure 1 . General view of the invention
Figure 2. Lateral sectional view of the invention
Figure 3. Isometric view of the invention Figure 4. Side view of the invention
Figure 5. Side view of the clamp component
Figure 6a. View of one half of the A-A sectional component
Figure 6b. View of the other half of the A-A sectional component Figure 7. View of the clamp locking mechanism of the invention Figure 8. Detailed view B
The correspondences of the reference numerals given in the figures are as follows:
1 . Main body
1 .1 . Perforated structure
2. Clamp
2.1 . Protrusion
3. Clamp
3.1 . Incline
4. Protrusion
5. Fixing apparatus
6. End portion
7. Housing
DETAILED DESCRIPTION OF THE INVENTION
The invention relates to a device designed to ensure the continuation of blood flow by establishing a connection between the aorta and an artificial vessel using a clamp (2, 3), in cases where an aneurysm (vessel dilation) and/or dissection (tearing of the vessel wall layers) develops in any segment of the aorta and the damaged aortic tissue needs to be replaced by an artificial vessel. The technical effect of the invention is to reduce intraoperative bleeding and shorten the anastomosis time. In order to achieve this technical effect, the invention comprises a main body (1), clamps (2, 3), a protrusion (4) on the clamps (2, 3), a fixing apparatus (5), an end portion (6), and a housing (7).
One end of the main body (1) shown in Figure 1 is inserted into the aorta, while the other end is placed into the graft, and clamps (2, 3) with a thickness of 1-2 mm are positioned over it to ensure a quick and effective connection between the graft and the aorta. The main body (1), which comes into contact with blood, is made of titanium material coated with pyrolytic carbon, while the clamps (2, 3), protrusion (4), fixing apparatus (5), end portion (6), and housing (7) are made of titanium.
A portion of the main body (1) comprises a perforated structure (1.1). As seen in the sectional view of the main body (1) provided in Figure 2, this perforated structure (1.1) is inserted into the aortic tissue. The main body (1) may be manufactured in different diameters and is selected according to the vessel diameter of the patient to be treated. The reasons for preferring this perforated structure (1.1), which has biocompatibility and optimal strength, on the main body (1) are to ensure the continued nourishment of the aortic tissue and to allow partial integration of the tissue into the perforations, thereby minimizing trauma to the aortic wall and enhancing the integrity of the connection.
As shown in Figure 3, the protrusion (2.1) located on the main body (1) serves as a boundary during the alignment of the ends of the aorta and the graft on a single plane. The incline (3.1) is an angled groove designed to angle the ends of the aorta and the graft, thereby enhancing the clamping performance of the clamps (2, 3).
In Figure 5, the structure of the clamps (2, 3) used to secure the aortic tissue and the graft onto the main body (1) shown in Figure 3 is illustrated. In the side view of the clamp (2, 3) presented in Section A in Figure 6, the form of the clamp (2, 3) can be seen. The clamp (2, 3) may be produced in any desired diameter. A clamp (2, 3) is selected in accordance with the diameter of the main body (1) to be used. As also shown in Figures 6a and 6b, the clamps (2, 3) are angled between 15 and 30 degrees. The reason for this is to apply different pressure forces at the connection points of the aorta and graft on the main body (1) in order to prevent potential vascular and graft damage and to increase the strength of the connection.
Figures 7 and 8 show the structure of the clamps (2, 3) and their locking mechanism. In Figure 7, the assembled state of the aortic vessel and artificial graft — intended to be joined — is illustrated on the main body (1) without the aortic vessel and graft being depicted. By measuring the diameters of the aorta and the graft, an appropriate main body (1) is selected. A proper match is achieved by measuring the available graft (with diameters ranging from 20 to 34 mm) and the section of the aorta where anastomosis is planned. The sections of the main body (1) where the aorta and graft connections are to be made are manufactured in various diameters in increments of 2 mm. This feature reduces the potential mismatch between the graft and aortic diameters, thereby enhancing the reliability and quality of the anastomosis. In Figure 2, the aorta is positioned between the clamp (3) and the perforated structure (1.1) of the main body (1), while the graft is positioned between the clamp (2) and the non-indented side of the main body (1). The tubular ends of the aorta and graft that are to undergo anastomosis are advanced up to the protrusion (2.1) indicated in Figure 4, ensuring both proper trimming of the vessel ends and close approximation of the aorta and graft. As previously mentioned, the aorta is positioned over the perforated structure of the main body (1) to enhance both tissue perfusion and structural integrity. Once a satisfactory continuity is established between the aorta, main body (1), and graft, the clamps (2, 3) are applied from above to secure the aorta and graft firmly onto the main body (1), ensuring stable fixation.
At the locking point, the diameter and wall thickness of the aorta and graft are measured, and the clamp diameter is selected in a way that prevents vascular damage and blood leakage. The clamps (2, 3), suitable for the diameter of the main body (1), are shown in Figure 7 with their end portion (6) passing through the housing (7) and being held in place by the protrusions (4) with the aid of a pliers. The connection section is designed with a durable metal structure, while a portion of the clamps (2, 3) is made of a strong fabric produced from dacron material. The clamps (2, 3) form a circular ring by passing both ends through each other. In order for the clamps (2, 3) to become a locked complete ring at the specified diameter, two separate protrusions (4) — which adhere to each other and resemble a projection — must be locked together. An oval rigid metal has been designed to enable locking. The component referred to as the fixing apparatus (5) is shown in Figure 8. The characteristic of the protruded structure here is that, when the two parts are joined, the clamps (2, 3) in their circular ring form appear as a "T" shape; and once the oval fixing apparatus (5) is placed, this "T" transforms into an "I" shape with the thickness of the "T" cap. In other words, the protrusions (4) resemble a "T" shape split vertically in half.
The protrusion (4) on the clamps (2, 3) and the fixing apparatus (5) serve as support during the compression of the clamps (2, 3) with pliers. After the clamps (2, 3) are sufficiently compressed, the housing (7), through which the extended end portion (6) of the clamp (2, 3) passes, ensures stabilization during the tightening of the clamp (2, 3).