WO2014194675A1 - Windowing method for covered stent in vascular cavity and windowing device for covered stent in vascular cavity - Google Patents

Abstract

A windowing device for a covered stent in a vascular cavity. The windowing device comprises a control system and an outer sleeve (1), as well as an extensible sleeve (2), a movable catheter (3) and a laser optical cable (6) which are located in the outer sleeve (1). The laser optical cable (6) is provided with an emission opening (6.1). Multiple elastic metal wires (5) are disposed at one end of the extensible sleeve (2). An ultrasonic positioning probe head (4) is disposed one end of the movable catheter (3). One elastic metal wire (5) of the multiple elastic metal wires (5) is connected to the emission opening (6.1). The movable catheter (3) is located in the extensible sleeve (2) and the other end is connected to the control system. The control system is also separately connected to the laser optical cable (6), the outer sleeve (1), and the other end of the extensible sleeve (2). Also provided is a windowing method for a covered stent in a vascular cavity. By using the device and the method for windowing of a covered stent, operation risk can be greatly reduced.

Description

 Vascular lumen stent graft window opening method and vascular lumen stent graft window opening device

 The invention relates to the technical field of intravascular stent grafts, in particular to a method for opening a window in a vascular lumen and a fenestration device for a stent in a vascular lumen. Background technique

 Aortic aneurysm is the most common aneurysm and is a major vascular disease that seriously threatens human life. In recent years, with the increase in the incidence of hypertension and arteriosclerosis and the aging of the population, the incidence of aortic aneurysm has increased year by year, which has become one of the common causes of sudden death in middle-aged and elderly people. The cause is mainly degenerative lesions in the middle aorta, which in turn leads to a weakening of the aortic wall and a bulbous expansion of the aortic lumen. According to pathological anatomy, it can be divided into: true aneurysm (full-thickness expansion of the vessel wall), pseudoaneurysm

(Currently surrounded by connective tissue after rupture of traumatic blood vessels), dissecting aneurysm (due to the tearing of the endometrium, the aorta forms a true cavity and the expansion of the false lumen). The disease is very dangerous and has a high rate of disability and death. According to related reports, if the aortic aneurysm is not treated in time, the five-year survival rate is only 17%. In the case of aortic dissection, if no active treatment is taken, the mortality rate can reach 21% in the first 24 hours of the onset, 49% in four days, and 93% in one year ( Anagnostopoulos CE, Elefteriades JA, Doroghazi RM ). With advances in imaging technology and a deeper understanding of aortic diseases, surgical treatments for such diseases are constantly evolving.

 Before the 1990s, surgery was the main treatment for aortic diseases. The main surgical methods are: 1. Aortic aneurysm resection and artificial vessel transplantation to reconstruct the aorta; 2. Aortic aneurysm encapsulation; 3. Aortic aneurysm wall tumor resection. The above three kinds of surgical treatments are not only traumatic, long operation time, many complications, high mortality, and can be carried out under the support of extracorporeal circulation support and deep hypothermic circulatory stop, so the requirements for patients' general condition and medical technology are high. Moreover, even if an experienced surgeon performs surgical treatment on a patient with a well-functioning elective surgery, the operative mortality rate is still 12-15%.

(DeBakey ME, Moreno-Cabral CE) The incidence of paraplegia in patients was 5-12%. In particular, aortic aneurysms are often found in elderly patients, often with heart, liver, lung, kidney and other multiple organ dysfunction and emergency surgery, the operative mortality rate is as high as 50% or higher (Moreno-Cabral CE). Interventional therapy is a treatment for aortic diseases developed after the 1990s. It is continuously applied to various incurable diseases, including: 1. Percutaneous endometrial fenestration, which is designed to be at the distal end of the dissection. Open the window, so that there is parallel blood flow between the true and false cavities, the purpose is to return the blood flow of the false lumen of the dissection aneurysm to the true cavity, to relieve the acute abdominal cavity and lower limb ischemia caused by the expansion of the false cavity and the pressure of the true cavity. To a certain role, but after all, is a kind of palliative surgery, in order to fundamentally eliminate the false cavity and endometrial rupture, only as an emergency treatment for further interventional treatment for surgery time, has been used less.

2. Endovascular grafting of the stent graft. This technique has the advantages of less trauma, faster postoperative recovery, less complications, and significantly shorter hospital stay than conventional open surgery, especially for high-aged patients with chronic diseases who cannot tolerate traditional surgery. . Since Dr. Parodi, Dr. Dake in 1994 and Dr. Nienaber in 1999 have been successfully treated with abdominal aortic aneurysm, thoracic descending aortic aneurysm and aortic dissection, now the aortic endoluminal stent graft has been It has become the best choice for the treatment of aneurysms, creating a milestone in the treatment of aortic dilatation diseases. Today, traditional surgery has been replaced in the treatment of some aortic dissections, aortic true aneurysms, and aortic pseudoaneurysms.

 However, there are still many technical bottlenecks in endoluminal stent graft implantation, which are mainly reflected in the following three situations: 1. The curvature and diameter of the proximal neck are too large; 2. There is a wall thrombus or plaque at the neck of the tumor. Piece;

3. The length of the neck is large. For Stanford B type thoracic aortic dissection aneurysm, it requires aortic rupture position 15 mm beyond the left subclavian artery opening. For abdominal aortic aneurysm, between the proximal and lower renal arteries is required. The distance is greater than 15mm. For patients who cannot meet the above-mentioned neck and neck requirements, the shorter the area that can be anchored by the stent graft, the more likely the stent graft is displaced or the proximal type I endoleak during and after surgery. However, in order to obtain a sufficient anchoring area, it is often necessary to close the left subclavian artery or the renal artery, the superior mesenteric artery, and the celiac trunk artery, further leading to fatal complications such as related organ ischemia. Therefore, about 25-40% of patients can not be treated with conventional stent-graft implantation. Bow-drop aortic aneurysm, proximal renal aortic aneurysm, and thoracic and abdominal aortic aneurysm become the current problem of endovascular graft exclusion. .

At present, the methods to solve this problem are as follows: 1. Covered stent implantation + surgical reconstruction of the closed artery. This method requires repeated angiographic evaluation of arterial blood supply before and after surgery, and open surgery to reconstruct the radial artery. Subclavian artery, internal carotid artery, renal artery, celiac trunk artery, mesenteric movement Pulse. It is only suitable for some patients with elective surgery with stable condition and general condition. For the emergency department, the successful operation of the relevant institutions has not been reported. The difficulty of surgery, the risk of surgery, the operation time and trauma are obvious. It is difficult to promote in middle-level medical institutions. , and the long-term prognosis of patients is not yet certain. 2. The membranous stent opens the window. The so-called fenestration is to open the hole in the position of the important visceral artery opening such as the renal artery, so that the stent can be anchored across the important artery and completely isolate the interlayer rupture. And prevention of endoleak, can also ensure the smooth flow of arterial blood perfusion of the above-mentioned important organs. However, it is difficult to open the window bracket in advance to open the window. It is difficult to accurately locate the opening of the important branch. It needs to be customized based on the accurate measurement of CTA imaging (layer thickness 1mm). From the patient visit to the stent production success time is long, many patients are aggravated or even drowned while waiting, greatly increasing the operative mortality rate of such patients. Moreover, such brackets are expensive. Not only that, because of individual differences, each person's aorta and the location, size, and direction of the opening of each branch are quite different, making it difficult to achieve individualized treatment. As far as current imaging technology is concerned, it is difficult to obtain accurate positioning of the three-dimensional space in the vascular lumen in vitro. Not only that, the methods required for such stent implantation include silver clip marking, left subclavian artery, renal artery marking, multi-angle fluoroscopy, etc., which is very difficult to operate. Therefore, how to achieve the fenestration of the stent graft in patients with complex aneurysms such as aortic aneurysm, proximal renal aortic aneurysm and thoracic and abdominal aortic aneurysm has become an international problem in interventional therapy. Summary of the invention

 The object of the present invention is to overcome the technical problem of fenestration of a stent in a vascular lumen, and to provide a fenestration method for a vascular stent and a fenestration device for a vascular stent, which can accurately locate The important artery branch covered by the stent graft is opened and the window is opened, and the blocked artery is opened, thereby achieving the interventional treatment of the patient with complicated aneurysm.

 In order to achieve the above object, the method for window opening of the intravascular stent graft according to the present invention comprises the following steps:

 1) implanting the stent graft into the vascular lumen such that at least one vessel mouth is blocked outside the tube wall of the stent graft;

2) placing the X-ray marker into the stent graft, and initially positioning the blocked vessel mouth by X-ray; 3) Place the ultrasonic component into the stent graft and move to the position of the vessel position that has been initially positioned, perform ultrasound to collect local vascular lumen parameters and images, and transmit, store, analyze the collected data, and complete the ultrasound. Three-dimensional reconstruction of the vascular lumen and identification of the wall structure, accurate positioning of the three-dimensional spatial position of the blocked vessel orifice;

 4) Inserting the laser emitting element into the stent graft and moving to the position of the vessel port that has been accurately positioned, so that the laser emitting port is close to the wall of the stent graft, triggering the laser beam, and opening the window to realize the coating stent. The blood flow blocked by the vascular orifice is recanalized.

 Preferably, the distance between the laser emitting port and the wall of the stent graft in the step 4) is 5-10 mm.

 Preferably, the power of the laser beam in the step 4) is 10-300 MW, the wavelength is 500-10000 nm, and the frequency is 3·846-7 · 895 χ 10" Ηζ.

 More preferably, the power of the laser beam is 50-100 MW, the wavelength is 3000-7000 nm, and the frequency is 4·568-6·755 χ 10" Ηζ.

 The vascular intraluminal stent graft fenestration device designed by the invention comprises a control system and an outer sleeve, and a telescopic sleeve, a moving conduit and a laser optical cable located in the outer sleeve;

 The laser cable is provided with an emission port;

 One end of the telescopic sleeve and one end of the moving conduit are respectively provided with a plurality of elastic wires and an ultrasonic positioning probe;

 The plurality of elastic wires are uniformly arranged in a trumpet shape, and one of the elastic wires is connected to the emission port;

 The moving conduit is located in the telescopic sleeve and the other end is connected to the control system;

 The control system is also connected to the other ends of the laser cable, the outer sleeve and the telescopic sleeve, respectively. Preferably, the elastic metal wires have a total of six, and one of the elastic metal wires is connected to the emission port.

 Preferably, the ultrasonic positioning probe comprises an X-ray marker and an ultrasound element.

 Preferably, the elastic metal wire is a stainless steel wire or a titanium alloy wire.

The invention has the beneficial effects: using the intravascular stent graft window opening method and the window opening device for in vivo stent graft fenestration will solve many vascular diseases that are currently clinically impossible to be implanted for stenting The surgical bottleneck problem of sick patients provides more survival opportunities for many patients; In-situ visibility operation is accurate, specific laser frequency window is safe, window opening with specific laser frequency, no damage to blood vessels, can be greatly Reduce the risk of surgery in patients. DRAWINGS

 1 is a schematic view showing the structure of a fenestration device for a stent in a vascular lumen according to the present invention.

 Fig. 2 is a schematic view showing the state of ultrasonic signal acquisition of the fenestration device of the intravascular stent graft in Fig. 1. Fig. 3 is a schematic view showing the laser windowing state of the fenestration device of the intravascular stent graft in Fig. 1. Fig. 4 is a schematic view showing the retracted state of the fenestration device of the intravascular stent graft in Fig. 1 after opening the window. In the figure: 1-outer cannula, 2-expansion cannula, 3-moving catheter, 4-ultrasonic positioning probe, 5-elastic wire, 6-laser cable (6.1 - launch port), 10-right renal artery, 11 - Abdominal aortic aneurysm, 12-stent graft. detailed description

 The invention is further described in detail below with reference to specific embodiments.

 As shown in Figure 1, the intravascular stent graft fenestration device comprises a control system (not shown) and an outer cannula 1, and a telescopic sleeve 2, a mobile catheter 3 and a laser cable 6 located in the outer cannula 1; The laser cable 6 is provided with an emission port 6.1;

 One end of the telescopic sleeve 2 and one end of the moving duct 3 are respectively provided with six elastic wires 5 and an ultrasonic positioning probe 4;

 The six elastic wires 5 are evenly arranged in a trumpet shape, and one of the elastic wires 5 is connected to the emission port 6.1;

 The moving conduit 3 is located inside the telescopic sleeve 2 and is connected to the control system at the other end;

 The control system is also connected to the other ends of the laser cable 6, the outer casing 1 and the telescopic casing 2, respectively. The ultrasonic positioning probe 4 includes an X-ray marker (not shown) and an ultrasonic component (not shown). The elastic wire 5 is a stainless steel wire or a titanium alloy wire.

It should be noted that the control system generally includes an electronic control portion and a manual propulsion control portion. The electronic control part is connected with the ultrasonic positioning probe 4 and the laser optical cable 6, and its function is to acquire, analyze data, and control Laser emission. The manual propulsion control portion can be designed with a special mechanical structure respectively connected to the end of the outer sleeve 1, the rear end of the moving duct 3, and the other end of the telescopic sleeve 2 to assist the parts to accurately move back and forth, or to omit the manual propulsion control portion. Only the end of the outer sleeve 1 is grasped by a human hand, the rear end of the moving duct 3 is moved, and the other end of the telescopic sleeve 2 is pushed and pulled to control the forward and backward of each part.

 The following is an example of venous fenestration repair of bilateral renal artery occlusion caused by endovascular grafting of complicated abdominal aortic aneurysm involving bilateral renal arteries, which illustrates the use of fenestration equipment in the vascular lumen. The procedure and the method of opening the window in the vascular lumen.

 A method for opening a window in a vascular lumen, comprising the following steps:

 1) The stent graft 12 is implanted into the intravascular (ie, intravascular lumen) of the abdominal aortic aneurysm 11 , and the left renal artery (not shown) and the right kidney are blocked outside the wall of the stent graft 12 . Arterial 10 vessel orifice;

2) Intravascular stent graft fenestration device is guided by the guide wire, and one side of the femoral artery (such as the left femoral artery) enters the stent graft 12 of the abdominal aorta (ie, the X-ray marker is placed into the membrane) In the stent 12, the ultrasonic positioning probe 4 is moved in the stent graft 12 at a controlled speed. Under the X-ray fluoroscopy condition, the X-ray marker in the ultrasonic positioning probe 4 can be used to substantially position the ultrasonic positioning probe 4 to be blocked. The position of the right renal artery 10 is open (ie, the position of the blocked right renal artery 10 vessel is initially positioned by X-ray), and the ultrasonic positioning probe 4 is contracted in the outer sleeve 1 and the telescopic sleeve 2;

 3) extending the ultrasonic positioning probe 4 from the outer cannula 1 and the telescopic cannula 2 (i.e., moving the ultrasonic component that has been placed in the stent graft 12 to the position of the 10th vascular orifice of the right renal artery that has been initially positioned) Ultrasound to acquire local venous parameters, images, and transmission and storage. The image includes all measurement types of vascular local features such as plaques, vascular margins, etc., combined with preoperative imaging data and analysis. The data, complete the three-dimensional reconstruction of the vascular lumen and the identification of the wall structure of the ultrasound, and accurately locate the three-dimensional spatial position of the 10 vascular orifice of the right renal artery;

4) The telescopic sleeve 2 is extended from the outer sleeve 1 at this time, one end of the elastic wire 5 is opened and abuts against the inner wall of the stent graft 12, and then the telescopic sleeve 2 is rotated to connect the laser optical cable 6 The elastic wire 5 is adjacent to the opening of the right renal artery 10, and the emission port 6.1 of the laser cable 6 is aligned with the opening of the right renal artery 10 (i.e., the laser emitting element that has been placed in the stent graft 12 is moved to The position of the right renal artery 10 vessel position has been accurately positioned, so that the laser emission port is as close as possible to the membranous branch The wall of the frame 12, but not directly in contact (holding distance is 5-10 mm), according to the size of the opening required on the stent graft 12, accurately determine the power, wavelength and frequency of the laser required to trigger the laser beam (in this embodiment) The power of the laser beam is 70 MW, the wavelength is 50,000 nm, and the frequency is 5.436×10 ¹⁴ Hz. The instantaneous gasification blocks the film of the stent graft 12 at the opening of the right renal artery 10, and the stent graft 12 is opened. The window realizes the recanalization of the blood flow of the 10 vessels of the right renal artery.

 After the above steps are completed, the ultrasonic positioning probe 4 and the telescopic sleeve 2 are retracted into the outer cannula 1, as shown in FIG. 4, the vascular opening device of the vascular stent is moved to the opening of the left renal artery, and the above step 2 is repeated. ) -4 ), to achieve blood flow recanalization of the left renal artery.

 Finally, under fluoroscopy, the contrast agent is administered, and the left renal artery and the right renal artery 10 blocked by the stent graft 12 are reviewed. If the arterial perfusion is good, the vascular opening device of the vascular stent is slow overall. If the wall of the stent graft 12 at the left renal artery or the right renal artery 10 is small, the ultrasound can be used again, and then the laser is used to open the smaller opening in the stent graft 12. Enlargement, at the same time, a small stent can be inserted into the left or right renal artery 10 to completely block the blood flow leaking from the laser opening into the aneurysm or in the interlayer.

Claims

claims 1. A method for fenestrating endovascular stent grafts, including the following steps: 1) Implant the covered stent into the vascular lumen so that the outside of the wall of the covered stent blocks at least one vascular orifice; 2) Place the X-ray marker into the stent graft, and use X-rays to initially locate the blocked vascular orifice; 3) Place the ultrasonic component into the stent graft and move it to the position of the vascular orifice that has been initially located. Perform ultrasound to collect local vascular lumen parameters and images, and transmit, store, and analyze the collected data to complete the ultrasonic treatment. Three-dimensional reconstruction of the vessel lumen and identification of the vessel wall structure, and accurate positioning of the three-dimensional spatial position of the blocked vessel orifice; 4) Place the laser emitting element into the stent graft and move it to the accurately positioned vessel opening, so that the laser emission port is close to the wall of the stent graft and then the laser beam is triggered to open the window of the stent graft to achieve Reopening of blood flow in blocked vascular orifices. 2. The method for opening a window in a vascular lumen of a stent graft according to claim 1, characterized in that: in step 4), the distance between the laser emission port and the wall of the stent graft is 5-10 mm. 3. The method for fenestrating intraluminal stent grafts according to claim 1 or 2, characterized in that: in step 4), the power of the laser beam is 10-300MW, the wavelength is 500-10000nm, and the frequency is 3 ·846-7 ·895χ 10"Ηζ. 4. The intravascular stent graft windowing method according to claim 3, characterized in that: the power of the laser beam is 50-100MW, the wavelength is 3000-7000nm, and the frequency is 4·568-6·755× 10"Ηζ. 5. A device for fenestrating endovascular stent grafts, characterized by: including a control system and an outer sleeve, as well as a telescopic sleeve, a movable catheter and a laser optical cable located in the outer sleeve; The laser optical cable is provided with a launch port; One end of the telescopic sleeve and one end of the movable conduit are respectively provided with a plurality of elastic metal wires and ultrasonic positioning probes; The plurality of elastic metal wires are evenly arranged in a trumpet shape, and one of the elastic metal wires is connected to the launch port; The mobile conduit is located in the telescopic sleeve and the other end is connected to the control system; The control system is also connected to the other end of the laser optical cable, the outer sleeve and the telescopic sleeve respectively. 6. The intraluminal stent graft fenestration device according to claim 5, characterized in that: there are six elastic metal wires in total, and one of the elastic metal wires is connected to the launch port. 7. The intraluminal stent graft fenestration device according to claim 5 or 6, characterized in that: the ultrasonic positioning probe includes an X-ray marker and an ultrasonic component. 8. The intraluminal stent graft fenestration device according to claim 5 or 6, characterized in that: the elastic metal wire is a stainless steel wire or a titanium alloy wire.