Endoleak measurement device for a fenestrated stent graft and working method thereof

Abstract

The present invention belongs to the field of medical device technology, and in particular relates to an internal leakage measurement device for a window-type covered stent and a working method thereof, comprising an in vitro bifurcated simulated vascular system and an in vitro constant pressure perfusion system connected to the in vitro bifurcated simulated vascular system, wherein the in vitro bifurcated simulated vascular system comprises a main pipe and a plurality of branch pipes connected to the main pipe, a main pipe bracket installed in the main pipe, and at least one branch pipe bracket installed in one of the branch pipes, wherein an internal leakage liquid collection tube is prefabricated at the starting position of the branch pipe. When performing internal leakage measurement, the present invention only needs to collect the circulating liquid flowing out of the internal leakage liquid collection tube to directly obtain the amount of internal leakage liquid, analyze the internal leakage between the main pipe bracket and the branch pipe bracket after the window is opened, and calculate the internal leakage rate of the branch pipe bracket. The system has a simple structure, is easy to use, and the measurement results are intuitive, stable, and reliable.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an endoleak measurement device for a fenestrated stent graft and a working method thereof. Background Art

[0002] Endovascular treatment of aortic arch lesions (type B aortic dissection and aortic arch aneurysm) typically utilizes a thoracic aortic stent graft to completely cover the affected arch segment. The aortic arch gives rise to three important supra-arch branch vessels, which supply the upper limbs and the brain, respectively, through the anterior and posterior circulation. For aortic arch lesions involving these important branches, the main thoracic aortic stent graft must simultaneously cover the arch lesion and reconstruct the supra-arch branch arteries. Reconstruction of the supra-arch branch arteries can be accomplished through pre-fenestration, in situ fenestration, and the use of modular branch stent grafts. Currently, the most commonly used technique is fenestration. This involves creating a "window" in the main thoracic aortic stent graft at the site of the supra-arch branch artery opening through acupuncture, radiofrequency ablation, or laser ablation. Branch stent grafts are then inserted through this window, preserving blood flow to the upper limbs and brain. However, because the main stent graft itself lacks a window, these physical fenestration methods often fail to ensure a perfect fit between the branch artery stent graft and the main stent graft, leading to blood leakage through the edges of the window and the branch stent graft, resulting in endoleaks. Large endoleaks can lead to incomplete isolation of aortic arch lesions by the stent graft, potentially resulting in poor long-term surgical outcomes and further disease progression. Therefore, effectively assessing the extent of endoleak in fenestrated stents is of great clinical significance. Summary of the Invention

[0003] The purpose of the present invention is to solve the technical problem of how to detect the degree of internal leakage between a fenestrated aortic covered stent and a branch stent, and to provide a device and a working method for measuring internal leakage of a fenestrated covered stent, which only needs to collect the circulating fluid flowing out of the internal leakage liquid collection tube to directly obtain the amount of internal leakage liquid, and calculate and analyze the internal leakage rate between the main pipe stent and the branch pipe stent after the window is opened. The device has a simple structure, is easy to use, and the measurement results are intuitive, stable, and reliable.

[0004] The technical solution of the present invention is: a device for measuring internal leakage of a window-type covered stent, comprising an in vitro bifurcated simulated vascular system and an in vitro constant pressure perfusion system connected to the in vitro bifurcated simulated vascular system, the in vitro bifurcated simulated vascular system comprising a main pipe and several branch pipes connected to the main pipe, a main pipe bracket installed in the main pipe and at least one branch pipe bracket installed in one of the branch pipes, an internal leakage liquid collection tube prefabricated at the starting position of the branch pipe.

[0005] Preferably, a hemispherical opening is provided at the starting position of the branch pipeline, and the internal leakage liquid collection pipe is prefabricated on the hemispherical opening.

[0006] Preferably, the inner diameter of the main pipe is 34 mm, the inner diameter of the branch pipe is 10 mm, the inner diameter of the internal leakage liquid collection pipe is 2 mm, and the materials of the main pipe, branch pipe and internal leakage liquid collection pipe are silicone or artificial rubber.

[0007] Preferably, the in vitro constant pressure perfusion system includes a circulating fluid tank, a simulated blood vessel fixing interface for connecting to a main body pipeline, and a constant pressure motor system for driving the circulating fluid to flow in the in vitro bifurcated simulated blood vessel system.

[0008] Preferably, the simulated blood vessel fixing interface is connected to one end of the main pipeline through a circulating fluid delivery tube, and the other end of the main pipeline is sealed by a No. 1 sealing rubber plug.

[0009] Preferably, the number of the branch pipes is three, and the three branch pipes are equidistantly connected to the same side of the main pipe, and the end of each branch pipe away from the main pipe is sealed by a No. 2 sealing rubber plug.

[0010] Preferably, the main conduit stent is a fenestrated aortic covered stent, which is divided into three types: single-fenestrated aortic covered stent, double-fenestrated aortic covered stent, and triple-fenestrated aortic covered stent, and the branch conduit stent is a branch artery covered stent.

[0011] A method for measuring endoleakage of a fenestrated stent graft comprises the following steps:

[0012] 1) First, remove the air remaining in the entire in vitro bifurcated simulated vascular system and the in vitro constant pressure perfusion system;

[0013] 2) Turn on the in vitro constant pressure perfusion system and operate it at 1.2 Hz and a pressure environment of 80-160 mmHg. The constant pressure motor system drives the circulating fluid to flow in the in vitro bifurcated simulated vascular system.

[0014] 3) The amount of internal leakage liquid is directly obtained by collecting the circulating fluid flowing out of the internal leakage collection tube at the starting position of the branch pipe. The internal leakage between the main pipe support and the branch pipe support after the window is opened is analyzed and evaluated, and the internal leakage rate of the branch pipe support is calculated.

[0015] When measuring internal leakage, the present invention only needs to collect the circulating liquid flowing out of the internal leakage liquid collection pipe to directly obtain the amount of internal leakage liquid, analyze the internal leakage situation between the main pipe support and the branch pipe support after the window is opened, and calculate the internal leakage rate of the branch pipe support. The system has a simple structure and is easy to use, and the measurement results are intuitive, stable and reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a schematic structural diagram of Example 1 of the present invention;

[0017] Figure 2 This is a schematic structural diagram of the in vitro bifurcated simulated vascular system in Example 1 of the present invention;

[0018] Figure 3 This is a schematic structural diagram of Example 2 of the present invention;

[0019] Figure 4 This is a schematic structural diagram of an in vitro bifurcated simulated vascular system in Example 2 of the present invention;

[0020] Figure 5 This is a schematic structural diagram of Example 3 of the present invention;

[0021] Figure 6 This is a schematic structural diagram of an in vitro bifurcated simulated vascular system in Example 3 of the present invention;

[0022] Figure 7 This is a schematic diagram of the structure of each pipeline of the in vitro bifurcated simulated vascular system of the present invention;

[0023] In the figure, 1. main pipe, 2. branch pipe, 3. internal leakage collection pipe, 4. main pipe bracket, 5. branch pipe bracket, 6. hemispherical opening, 7. extracorporeal constant pressure perfusion system, 8. circulating fluid delivery pipe, 9. No. 1 sealing rubber plug, 10. No. 2 sealing rubber plug. DETAILED DESCRIPTION

[0024] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments, but this does not limit the scope of protection of the present invention.

[0025] Example 1

[0026] like Figure 1 、 2As shown in Figure 7, a device for measuring internal leakage of a fenestrated covered stent comprises an in vitro bifurcated simulated vascular system and an in vitro constant-pressure perfusion system 7 connected to the in vitro bifurcated simulated vascular system. The in vitro bifurcated simulated vascular system comprises a main conduit 1 and three branch conduits 2 connected to the main conduit 1, as well as a main conduit support 4 installed within the main conduit 1 and a branch conduit support 5 installed within one of the branch conduits 2. An internal leakage collection tube 3 is prefabricated at the starting position of each branch conduit 2. A hemispherical opening 6 is provided at the starting position of each branch conduit 2, and the internal leakage collection tube 3 is prefabricated in the hemispherical opening 6. The inner diameter of the main conduit 1 is 34 mm, the inner diameter of the branch conduit 2 is 10 mm, and the inner diameter of the internal leakage collection tube 3 is 2 mm. The main conduit 1, branch conduits 2, and internal leakage collection tube 3 are made of silicone or synthetic rubber. The in vitro constant-pressure perfusion system 7 comprises a circulating fluid tank, a simulated vascular fixed interface for connecting to the main conduit, and a constant-pressure motor system for driving the circulating fluid to flow in the in vitro bifurcated simulated vascular system. The simulated vascular fixation interface is connected to one end of the main conduit 1 via a circulating fluid delivery tube 8. The other end of the main conduit 1 is sealed with a No. 1 rubber plug 9. Three branch conduits are equidistantly connected to the same side of the main conduit 1, and the end of each branch conduit away from the main conduit is sealed with a No. 2 rubber plug 10. The main conduit stent 4 is a single-fenestrated aortic stent graft, and the branch conduit stent 5 is a branch artery stent graft.

[0027] Example 2

[0028] like Figure 3 、 4 As shown in Figure 7, the in vitro bifurcated simulated vascular system includes a main pipe 1 and three branch pipes 2 connected to the main pipe 1, as well as a main pipe stent 4 installed in the main pipe 1 and two branch pipe stents 5 installed in two of the branch pipes 2 respectively. The main pipe stent 4 is a double-window aortic covered stent, and the branch pipe stent 5 is a branch artery covered stent.

[0029] Example 3

[0030] like Figure 5-7 As shown, the in vitro bifurcated simulated vascular system includes a main pipe 1 and three branch pipes 2 connected to the main pipe 1, as well as a main pipe stent 4 installed in the main pipe 1 and three branch pipe stents 5 installed in the three branch pipes 2 respectively. The main pipe stent 4 is a three-window aortic covered stent, and the branch pipe stent 5 is a branch artery covered stent.

[0031] A method for measuring endoleakage of a fenestrated stent graft comprises the following steps:

[0032] 1) First, remove the air remaining in the entire in vitro bifurcated simulated vascular system and the in vitro constant pressure perfusion system;

[0033] 2) Turn on the in vitro constant pressure perfusion system and operate it at 1.2 Hz and a pressure environment of 80-160 mmHg. The constant pressure motor system drives the circulating fluid to flow in the in vitro bifurcated simulated vascular system.

[0034] 3) The amount of internal leakage liquid is directly obtained by collecting the circulating liquid flowing out of the internal leakage collection tube at the starting position of the branch pipe. The internal leakage between the main pipe support and the branch pipe support after the window is opened is analyzed and evaluated, and the internal leakage rate of the branch pipe support is calculated.

[0035] The extracorporeal constant pressure perfusion system in the present invention is a conventional device purchased on the market. Its specific structure and working process are conventional means, so they are not described in detail.

[0036] When performing endoleak measurement, the present invention perfuses circulating fluid into an in vitro bifurcated simulated vascular system, and a constant pressure motor system drives the circulating fluid to perfuse the circulating fluid into the vascular simulation system at a constant pressure; after a certain period of time, the circulating fluid flowing out of the endoleak collection tube on the side wall of the simulated branch blood vessel is collected to directly obtain the amount of endoleak fluid, analyze the endoleak situation between the main pipe support and the branch pipe support after the window is opened, and calculate the endoleak rate of the branch pipe support after the window is opened; the structure is simple, the use is easy, and the measurement results are intuitive, stable and reliable.

Claims

1. A device for measuring endoleakage of a fenestrated stent graft, characterized by: The invention comprises an in vitro bifurcated simulated vascular system and an in vitro constant pressure perfusion system connected to the in vitro bifurcated simulated vascular system. The in vitro bifurcated simulated vascular system comprises a main pipe and a plurality of branch pipes connected to the main pipe, a main pipe bracket installed in the main pipe, and at least one branch pipe bracket installed in one of the branch pipes. An internal leakage collection tube is prefabricated at the starting position of the branch pipe. A hemispherical opening is provided at the starting position of the branch pipe, and the internal leakage liquid collection pipe is prefabricated on the hemispherical opening; The in vitro constant pressure perfusion system includes a circulating fluid tank, a simulated blood vessel fixing interface for connecting to a main body pipeline, and a constant pressure motor system for driving the circulating fluid to flow in the in vitro bifurcated simulated blood vessel system; The working method of the endoleak measurement device of the fenestrated covered stent comprises the following steps: 1) First, remove the air remaining in the entire in vitro bifurcated simulated vascular system and the in vitro constant pressure perfusion system; 2) Start the in vitro constant pressure perfusion system and operate it at 1.2 Hz and a pressure environment of 80-160 mmHg. The constant pressure motor system drives the circulating fluid to flow in the in vitro bifurcated simulated vascular system. 3) By collecting the circulating fluid flowing out of the internal leakage collection tube at the starting position of the branch pipe, the internal leakage amount is directly obtained. The internal leakage between the main pipe support and the branch pipe support after the window is opened is analyzed and evaluated, and the internal leakage rate of the branch pipe support is calculated.

2. The endoleak measurement device for a fenestrated stent graft according to claim 1, characterized in that: The inner diameter of the main pipe is 34 mm, the inner diameter of the branch pipe is 10 mm, the inner diameter of the internal leakage liquid collection pipe is 2 mm, and the main pipe, branch pipe and internal leakage liquid collection pipe are made of artificial rubber.

3. The endoleak measurement device for a fenestrated stent graft according to claim 1, characterized in that: The simulated blood vessel fixing interface is connected to one end of the main pipeline through a circulating fluid delivery tube, and the other end of the main pipeline is sealed by a No. 1 sealing rubber plug.

4. The endoleak measurement device for a fenestrated stent graft according to claim 1, characterized in that: There are three branch pipes, which are equidistantly connected to the same side of the main pipe, and the end of each branch pipe away from the main pipe is sealed by a No. 2 sealing rubber plug.

5. The endoleak measurement device for a fenestrated stent graft according to claim 1, characterized in that: The main conduit stent is a fenestrated aortic covered stent, which is divided into three types: a single-fenestrated aortic covered stent, a double-fenestrated aortic covered stent, and a triple-fenestrated aortic covered stent. The branch conduit stent is a branch artery covered stent.

Images