Aorta covered stent in-situ windowing system

Abstract

The invention discloses an aorta covered stent in-situ fenestration system, and relates to the technical field of medical instruments, the aorta covered stent in-situ fenestration system comprises a sheath tube assembly, a sheath core assembly and a puncture needle assembly, the sheath core assembly is installed on the sheath tube assembly, the puncture needle assembly is installed on the sheath core assembly, the sheath tube assembly comprises a sheath tube body, and the sheath core body is of a bendable structure; according to the aorta covered stent in-situ fenestration system, aorta branch fenestration is conducted to treat aortic arch lesions, the aortic arch and branch blood vessels can be reconstructed completely in a minimally invasive mode through the interventional technology, thoracotomy and extracorporeal circulation are not needed, the operation is simple, the operation is convenient, and the cost is low. Operation wounds are greatly reduced, complications caused by thoracotomy, extracorporeal circulation and circulation arrest are avoided, branch blood vessels are reconstructed through the windowing technology, blood vessel suture is avoided, and the risk of bleeding is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an in-situ fenestration system for an aortic stent graft. Background Art

[0002] my country has a large population base, with about 200 million patients suffering from hypertension, many of whom also suffer from aortic arch lesions. A large number of patients with congenital connective tissue diseases (such as Marfan syndrome) also suffer from aortic arch lesions. Aortic arch lesions include aortic arch aneurysms and aortic dissections. The main risk is rupture, which is life-threatening. Aortic arch lesions are a type of lesion with a wide incidence and extremely high risk, which endangers the patient's life. Once discovered, they need to be actively treated and surgically treated as soon as possible. The surgical technique for aortic arch lesions is complex and the surgical risk is high. The traditional surgical method is Sun's operation, which is a combination of artificial blood vessel replacement of the aortic arch and reconstruction of the brachiocephalic vascular branches under extracorporeal circulation. The incidence of intraoperative bleeding and postoperative neurological and respiratory complications is high.

[0003] The current surgical steps are as follows:

[0004] 1. Intubate to establish extracorporeal circulation, cool to a rectal temperature of 25 degrees, stop extracorporeal circulation, open the aortic arch, and implant a stent in the descending aorta;

[0005] 2. Suture the four-branch artificial blood vessel with the stent and the aortic arch to complete the distal anastomosis of the arch;

[0006] 3. After reconstruction of the left common carotid artery, resume extracorporeal circulation and begin to restore body temperature;

[0007] 4. The four-branch artificial blood vessel is anastomosed to the ascending aorta to complete the proximal anastomosis of the arch;

[0008] 5. Reconstruction of the left subclavian artery;

[0009] 6. Reconstruct the innominate artery.

[0010] The existing technical solution requires thoracotomy and establishment of extracorporeal circulation. In order to protect the brain and obtain a bloodless surgical field during the anastomosis of the aortic arch blood vessels, the body temperature needs to be reduced from 37 degrees to 25 degrees. During the implantation of the stent blood vessel into the descending aorta and the anastomosis of the distal end of the arch, there is no blood supply to the lower body for about 20 to 30 minutes, and the brain is only perfused unilaterally. Hypothermia seriously disrupts the normal physiological state, and coupled with the effects of ischemia, it can cause damage to the nervous system and internal organs. Multiple blood vessels need to be sutured during the operation. Patients with arch lesions have abnormal aortic arch blood vessels, and hypothermia affects the normal coagulation function. Bleeding is also a major complication of this operation. Therefore, those skilled in the art provide an aortic stent graft in situ windowing system to solve the problems raised in the above background technology. Summary of the Invention

[0011] In order to solve the above technical problems, the present invention provides an in situ fenestration system for an aortic covered stent, including a sheath assembly, a sheath core assembly and a puncture needle assembly, the sheath core assembly is installed on the sheath assembly, and the puncture needle assembly is installed on the sheath core assembly, the sheath assembly includes a sheath body, and the sheath core body is a flexible structure; the puncture needle assembly includes a puncture needle body, and the puncture needle body is a flexible structure.

[0012] Preferably, a first developing area is provided on the sheath body, and the first developing area is located at the head end of the sheath body.

[0013] Preferably, a second developing area is provided on the sheath body, and the second developing area is located in the middle section of the sheath body.

[0014] Preferably, the sheath body is further provided with a third developing area, and the third developing area is located in the front third of the sheath body.

[0015] Preferably, the first developing area, the second developing area and the third developing area are each provided with a plurality of developing rings, and the developing rings are each made of a hydrophilic coating and a developing material.

[0016] Preferably, the sheath core body is a hollow tubular structure for passing through the puncture needle body. The sheath core body comprises a sheath core head end, a sheath core middle section and a sheath core tail section, and the sheath core tail section is connected to the sheath core fixing ring.

[0017] Preferably, the sheath core head end and the sheath core tail section are made of hard materials, and the sheath core middle section is made of soft materials.

[0018] Preferably, the sheath core body is made of PVC material.

[0019] Preferably, the puncture needle body is a hollow tubular structure for passing the guide wire. The puncture needle body comprises a puncture needle head section, a puncture needle middle section and a puncture needle tail section, and the puncture needle tail section is connected to the puncture needle guide connecting sleeve.

[0020] Preferably, the puncture needle body is made of PVC material.

[0021] The technical effects and advantages of the present invention are as follows:

[0022] 1. The aortic stent graft in situ fenestration system of the present invention performs aortic branch fenestration to treat aortic arch lesions, which is completely minimally invasive. It uses interventional technology to reconstruct the aortic arch and branch vessels without the need for thoracotomy and extracorporeal circulation, greatly reducing surgical trauma and avoiding complications caused by thoracotomy, extracorporeal circulation and circulatory arrest. The fenestration technology reconstructs branch vessels, avoids vascular suturing, and reduces the risk of bleeding.

[0023] 2. In the present invention, after the sheath core body enters the blood vessel, it can follow the curved blood vessel, making it easier for the puncture needle body to reach the desired position, avoiding iatrogenic damage to the blood vessel caused by the traditional hard sheath core body, and greatly improving the success rate of window opening.

[0024] 3. In the present invention, after the puncture needle body enters the blood vessel, it can conform to the curved sheath core body and blood vessel while maintaining a certain hardness to ensure smooth membrane rupture. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram of the structure of the in situ fenestration system for the aortic stent graft provided in an embodiment of the present application;

[0026] Figure 2 2. It is a structural schematic diagram of the sheath-core assembly in the in situ fenestration system of the aortic stent graft provided in an embodiment of the present application;

[0027] Figure 3 It is a structural schematic diagram of the puncture needle assembly in the in situ fenestration system of the aortic covered stent provided in an embodiment of the present application.

[0028] Figure 4 This is an angiographic image of the puncture needle body puncturing the membrane in the in situ fenestration system of the aortic stent graft provided in an embodiment of the present application;

[0029] Figure 5 This is an angiographic image of the fully deployed stent in the in situ fenestration system of the aortic covered stent provided in an embodiment of the present application.

[0030] In the figure: 1. Sheath assembly; 11. Sheath handle; 12. Sheath body; 121. First developing area; 122. Second developing area; 123. Third developing area; 2. Sheath core assembly; 21. Sheath core head section; 22. Sheath core middle section; 23. Sheath core tail section; 24. Sheath core fixing ring; 3. Puncture needle assembly; 31. Puncture needle head section; 32. Puncture needle middle section; 33. Puncture needle tail section; 34. Puncture needle guide connecting sleeve. DETAILED DESCRIPTION

[0031] The present invention will be described in further detail below with reference to the accompanying drawings and specific embodiments. The embodiments of the present invention are provided for purposes of illustration and description and are not intended to be exhaustive or to limit the invention to the disclosed forms. Many modifications and variations will be apparent to those skilled in the art. The embodiments are chosen and described to better illustrate the principles of the invention and its practical application, and to enable those skilled in the art to understand the invention and design various embodiments with various modifications suitable for specific applications.

[0032] See also Figure 1In this embodiment, an aortic covered stent in situ fenestration system is provided, which includes a sheath tube assembly 1, a sheath core assembly 2 and a puncture needle assembly 3. The sheath core assembly 2 is installed on the sheath tube assembly 1, and the puncture needle assembly 3 is installed on the sheath core assembly 2.

[0033] Specifically, the sheath assembly 1 includes a sheath body 12 , and the sheath body 12 is provided with a developing area to facilitate judging the depth of the sheath body 12 into the blood vessel, puncturing the membrane and releasing the stent.

[0034] The sheath core assembly 2 includes a sheath core body, which is a bendable structure. In the first state, the deformation of the sheath core body is small, and the sheath core body is in the shape of a long strip. In the second state, the sheath core body is curved and can follow the curved blood vessels, making it easier for the puncture needle body to reach the desired position, avoiding damage to the blood vessels by the puncture needle body, and greatly improving the success rate of window opening.

[0035] The puncture needle assembly 3 includes a puncture needle body, which is a flexible structure. In the first state, the deformation of the puncture needle body is small and the puncture needle body is long and narrow. In the second state, the puncture needle body is curved, which is convenient for conforming to the blood vessels and can also maintain a certain hardness to ensure smooth membrane rupture.

[0036] The in situ fenestration system for aortic branches using the aortic stent graft of the present invention is a minimally invasive method for treating aortic arch lesions. It uses interventional techniques to reconstruct the aortic arch and branch vessels without requiring thoracotomy or extracorporeal circulation, significantly reducing surgical trauma and avoiding complications associated with thoracotomy, extracorporeal circulation, and circulatory arrest. The fenestration technique for reconstructing branch vessels eliminates the need for vascular suturing and reduces the risk of bleeding. Furthermore, it can achieve excellent therapeutic results.

[0037] Furthermore, in this embodiment, the sheath assembly 1 further includes a sheath handle 11 , which is connected to the sheath body 12 . The sheath handle 11 is conventional and will not be described in detail herein.

[0038] Furthermore, a first developing area 121 is provided on the sheath body 12 . The first developing area 121 is located at the head end of the sheath body 12 . When the sheath body 12 enters the blood vessel, the head end of the sheath body 12 is conveniently located through the first developing area 121 .

[0039] Furthermore, a second developing area 122 is provided on the sheath body 12 . The second developing area 122 is located in the middle section of the sheath body 12 . When the sheath body 12 enters the blood vessel, the middle section of the sheath body 12 is conveniently located through the second developing area 122 .

[0040] Furthermore, a third developing area 123 is provided on the sheath body 12. The third developing area 123 is located in the front one-third section of the sheath body 12. When the sheath body 12 enters the blood vessel, the front one-third section of the sheath body 12 is conveniently positioned through the third developing area 123.

[0041] The first developing area 121, the second developing area 122 and the third developing area 123 are all provided with multiple developing rings, which are made of hydrophilic coating and developing material, and the metal developing material is covered with silicon coating. While lubricating the guide wire, intraoperative positioning is achieved through the metal developing mark, making the direction of the sheath body 12 entering the blood vessel clearer.

[0042] In this embodiment, the metal developing material includes but is not limited to tantalum, tungsten, and platinum alloy.

[0043] See Figure 2 As shown, the sheath core body is a hollow tubular structure used to pass through the puncture needle body, including a sheath core head section 21, a sheath core middle section 22 and a sheath core tail section 23. The sheath core tail section 23 is connected to the sheath core fixing ring 24. The sheath core head section 21 and the sheath core tail section 23 are made of hard materials, and the sheath core middle section 22 is made of soft materials. After the sheath core body enters the blood vessel, it can follow the curved blood vessel to facilitate the puncture needle body to reach the desired position, avoid the iatrogenic damage to the blood vessel caused by the traditional hard sheath core body, and greatly improve the success rate of window opening.

[0044] Furthermore, the sheath core body is made of PVC material and can be made into an integral shape, which has a low production cost.

[0045] See Figure 3 As shown, the puncture needle body is a hollow tubular structure used to pass through the guide wire, including a puncture needle head section 31, a puncture needle middle section 32 and a puncture needle tail section 33. The puncture needle tail section 33 is connected to the puncture needle guide connecting sleeve 34. The puncture needle head section 31 and the puncture needle tail section 33 are made of hard material, and the puncture needle middle section 32 is made of soft material. After the puncture needle body enters the blood vessel, it can conform to the curved sheath core body and blood vessel while maintaining a certain hardness to ensure smooth membrane rupture.

[0046] Furthermore, the puncture needle body is made of PVC material and can be made into an integral shape, so the production cost is low.

[0047] It should be understood that the puncture needle body of the present application can directly pass through the 035 guide wire (the diameter of the guide wire is 0.035 inches). Compared with the prior art, which uses a hard puncture needle and can only pass through the 018 guide wire (the diameter of the guide wire is 0.018 inches), and then pass the 035 guide wire after the blood vessel is unblocked, the operation has more steps, resulting in a long operation time and long exposure of the surgeon and the patient to X-rays. The puncture needle body of the present application can make the operation more convenient, simplify the surgical steps, reduce the operation time and the exposure time to X-rays, and reduce radiation damage to the surgeon and the patient.

[0048] Furthermore, the length of the hollow flexible puncture needle body is greater than the length of the hollow flexible sheath core body. In one embodiment, the length of the sheath core body is 20 cm, and the length of the puncture needle body is 23 cm.

[0049] During use, a small incision is made on the left neck to expose the left subclavian artery and left common carotid artery, and the sheath body 12 in this kit is pre-placed. Based on the preoperative CTA (CT angiography) measurement results, an aortic stent graft of appropriate size is selected and the aortic stent graft is inserted through the femoral artery to cover the aortic arch lesion, in order to obtain a sufficient anchoring area and cover the adjacent branch vessels at the same time;

[0050] Branch artery fenestration: The tip of the sheath body 12 can be visualized under X-rays, and the top of the pre-placed sheath body 12 is pressed against the aortic stent graft;

[0051] The first developing area 121 of the sheath body 12 can clearly see the position of the head end of the sheath body 12 under DSA (subtraction angiography). The hollow flexible sheath core body in this kit is implanted through the sheath body 12, and the flexible puncture needle body is implanted through the sheath core body. The sheath core body has two functions. On the one hand, it can guide the puncture needle; on the other hand, it can protect the blood vessel from damage by the puncture needle. The puncture needle body is used to puncture the corresponding part of the aortic stent. The puncture needle body is also hollow and can pass through a 0.035 guide wire. The sheath core body and the puncture needle body are both flexible to adapt to the course of the branch blood vessels. The sheath core body and the puncture needle body are both flexible to adapt to the course of the branch blood vessels. The needle body is simultaneously pressed against the membrane, and the puncture needle body is sent forward to rupture the membrane. The guide wire is sent forward through the puncture needle body to the ascending artery, and the puncture needle body and the sheath core body are withdrawn. 4mm and 8mm balloons are respectively sent along the guide wire to expand the ruptured membrane position to enlarge the window. Then, a covered stent of the corresponding size of the branch artery is inserted, and the balloon is post-dilated to fully expand the stent. The aortic arch and branch vessels are reconstructed through completely intravascular technology, without the need for thoracotomy, extracorporeal circulation and cooling. The aortic arch window kit is used to reconstruct the branch vessels, and vascular suturing is also not required, which reduces the risk of bleeding and can achieve good therapeutic effects.

[0052] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field and related fields without making creative efforts should fall within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described and explained in the present invention shall be implemented in accordance with conventional means in the field unless otherwise specified or limited.

Claims

1. An in situ fenestration system for an aortic stent graft, comprising a sheath assembly, a sheath core assembly, and a puncture needle assembly, characterized in that: The sheath core assembly is installed on the sheath tube assembly, and the puncture needle assembly is installed on the sheath core assembly. The sheath tube assembly includes a sheath tube body, and the sheath core body is a bendable structure; the puncture needle assembly includes a puncture needle body, and the puncture needle body is a bendable structure.

2. The in situ fenestration system for an aortic stent graft according to claim 1, characterized in that: The sheath tube body is provided with a first developing area, and the first developing area is located at the head end of the sheath tube body.

3. The in situ fenestration system for an aortic stent graft according to claim 2, characterized in that: The sheath tube body is provided with a second developing area, and the second developing area is located in the middle section of the sheath tube body.

4. The in situ fenestration system for an aortic stent graft according to claim 3, characterized in that: The sheath body is also provided with a third developing area, which is located in the front third of the sheath body.

5. The in situ fenestration system for an aortic stent graft according to claim 4, characterized in that: The first developing area, the second developing area and the third developing area are all provided with a plurality of developing rings, and the developing rings are all made of a hydrophilic coating and a developing material.

6. The in situ fenestration system for an aortic stent graft according to claim 1, characterized in that: The sheath core body is a hollow tubular structure used to pass through the puncture needle body. The sheath core body includes a sheath core head end, a sheath core middle section and a sheath core tail section, and the sheath core tail section is connected to the sheath core fixing ring.

7. The in situ fenestration system for an aortic stent graft according to claim 6, characterized in that: The sheath core head end and the sheath core tail section are made of hard materials, and the sheath core middle section is made of soft materials.

8. The in situ fenestration system for an aortic stent graft according to claim 7, characterized in that: The sheath core body is made of PVC material.

9. The in situ fenestration system for an aortic stent graft according to claim 1, characterized in that: The puncture needle body is a hollow tubular structure used for passing the guide wire. The puncture needle body includes a puncture needle head section, a puncture needle middle section and a puncture needle tail section. The puncture needle tail section is connected to the puncture needle guide connecting sleeve.

10. The in situ fenestration system for an aortic stent graft according to claim 9, characterized in that: The puncture needle body is made of PVC material.

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