Integrated stent-type artificial blood vessel

Abstract

An integrated stent-type artificial blood vessel, comprising: an artificial blood vessel portion (1), wherein the artificial blood vessel portion (1) comprises a main artificial blood vessel trunk (11), and the main artificial blood vessel trunk (11) is configured to be arranged corresponding to an ascending aorta of a human body; a covered stent (2), wherein the covered stent (2) comprises a main covered stent trunk (21) and a left subclavian artery branch trunk (22) provided on the side of and in communication with the main covered stent trunk (21); and a bendable connecting tube segment (3), provided between the artificial blood vessel portion (1) and the covered stent (2), wherein the bendable connecting tube segment (3) comprises a main tube segment (31) and a short side tubular connector (32) provided beside and in communication with the main tube segment (31). In a primary blood flow direction of the artificial blood vessel, the proximal end of the main tube segment (31) is connected to the main artificial blood vessel trunk (11), the distal end of the main tube segment (31) is connected to the proximal end of the main covered stent trunk (21), and the short side tubular connector (32) is connected to a short covered tubular stent (23).

Description

Integrated stent-type artificial blood vessel Technical Field

[0001] The present application relates to the technical field of artificial blood vessel medical devices, and in particular to an integrated stent-type artificial blood vessel. Background Art

[0002] Currently, traditional surgery for aortic dissection requires freeing the brachiocephalic trunk branches, left common carotid artery, and left subclavian artery. Under circulatory arrest, the covered stent is placed into the true lumen of the descending aorta. The covered stent is set separately from the four-branch artificial blood vessel. Therefore, the proximal end of the covered stent needs to be sutured to the distal end of the four-branch artificial blood vessel and the autologous aortic wall. Exposure is difficult, there is backflow interference during suturing, and the free suture space is limited, which increases the difficulty of anastomosis, thereby prolonging the circulatory arrest time and affecting the protection of brain tissue. In addition, the difficulty of surgical operation can easily lead to the risk of bleeding after anastomosis, prolonging the overall operation time, increasing the extracorporeal circulation time, and being detrimental to postoperative recovery. Summary of the Invention

[0003] The integrated stent-type artificial blood vessel provided in this application includes:

[0004] The artificial blood vessel portion includes an artificial blood vessel main branch, which is used to correspond to the ascending aorta of the human body;

[0005] The stent graft comprises a stent graft trunk and a left subclavian artery branch arranged beside the stent graft trunk and connected to the stent graft trunk;

[0006] The flexible connecting pipe section is arranged between the artificial blood vessel part and the coated stent. The flexible connecting pipe section includes a main pipe section and a short side tubular joint arranged beside the main pipe section and connected to the main pipe section. In the main blood flow direction of the artificial blood vessel, the proximal end of the main pipe section is connected to the main branch of the artificial blood vessel, and the distal end of the main pipe section is connected to the proximal end of the main branch of the artificial blood vessel. The coated short tubular stent is connected to the short side tubular joint.

[0007] The integrated stent-type artificial blood vessel provided by the present application has an integrated design in which the artificial blood vessel part and the covered stent are connected. This avoids the problem of difficult exposure caused by the need to suture the proximal end of the covered stent with the distal end of the four-branch artificial blood vessel and the wall of the native aorta. There is no need to anastomose the stent and the artificial blood vessel during surgery, which reduces the anastomosis time and avoids the risk of bleeding at the anastomosis site. The covered stent includes a branch of the left subclavian artery. After the native aorta is cut open in the area between the native left common carotid artery and the native left subclavian artery, the branch of the left subclavian artery can be inserted into the native left subclavian artery, avoiding the freedom of the native left subclavian artery during surgery and avoiding the need to anastomose a branch of the artificial blood vessel with the native left subclavian artery, thereby reducing operations and reducing operation time.

[0008] The integrated stent-type artificial blood vessel provided in the present application is also provided with a flexible connecting pipe segment, which is arranged between the artificial blood vessel portion and the stent graft. The main pipe segment on the flexible connecting pipe segment is flexible and can well adapt to the curved structure of the human aortic arch.

[0009] Moreover, the short tubular connector on the flexible connecting pipe segment and the corresponding coated short tubular stent form an artificial arterial branch that can be directly inserted into the branch artery of the human aorta. Based on the bendability of the main pipe segment, it can be well adapted to the shape and structure of the arch of the human aorta. The artificial arterial branch (composed of the short tubular connector and the corresponding connected coated short tubular stent) can enter the human aorta through the dissected aorta and be directly inserted into the corresponding human arterial branch (for example, the brachiocephalic artery and / or the left common carotid artery), saving the steps required in existing aortic dissection surgery, such as resection of the brachiocephalic artery, the left common carotid artery or the left subclavian artery, freeing and then suturing with the artificial branch blood vessel. In general, the present application provides an integrated stent-type artificial blood vessel with a flexible connector, which can conform to the aortic morphology very well as a whole, avoiding problems such as necrosis and rupture of the aortic wall caused by binding and ligation after surgery. The integrated stent-type artificial blood vessel saves the number of free branch arteries required during surgery, thereby saving free anastomosis time, reducing circulatory arrest time, restoring systemic circulation as soon as possible, enhancing protection of brain tissue, reducing the risk of post-anastomosis bleeding, shortening the overall operation time and extracorporeal circulation time, and facilitating the patient's postoperative recovery.

[0010] In some optional embodiments of the present application, an integrated stent-type artificial blood vessel includes:

[0011] The artificial blood vessel portion includes an artificial blood vessel main branch, which is used to correspond to the ascending aorta of the human body;

[0012] The stent graft comprises a stent graft trunk and a left subclavian artery branch arranged beside the stent graft trunk and connected to the stent graft trunk;

[0013] The flexible connecting pipe section is arranged between the artificial blood vessel part and the coated stent. The flexible connecting pipe section includes a main pipe section and a short side tubular joint arranged beside the main pipe section and connected to the main pipe section. In the main blood flow direction of the artificial blood vessel, the proximal end of the main pipe section is connected to the main branch of the artificial blood vessel, and the distal end of the main pipe section is connected to the proximal end of the main branch of the artificial blood vessel. The coated short tubular stent is connected to the short side tubular joint.

[0014] In some optional embodiments of the present application, the present invention further includes:

[0015] The anti-reflux cap is arranged around the outer periphery of the connection between the main branch and the main pipe section of the artificial blood vessel, and the cap opening of the anti-reflux cap faces the flexible connecting pipe section.

[0016] In some optional embodiments of the present application, the anti-reflux cap and the artificial blood vessel portion are made of the same material.

[0017] In some optional embodiments of the present application, the brim of the anti-reflux cap is cylindrical.

[0018] In some optional embodiments of the present application, the brim of the anti-reflux cap is truncated cone-shaped, and the diameter of the bottom end of the brim of the anti-reflux cap close to the main pipe section is larger than the diameter of the top end of the brim of the anti-reflux cap close to the main pipe section.

[0019] In some optional embodiments of the present application, the proximal diameter of the stent graft trunk is larger than the distal diameter of the main tube section.

[0020] In some optional embodiments of the present application, the ratio of the proximal diameter of the stent graft trunk to the distal diameter of the main tube section is in the range of 1.06 to 1.9;

[0021] In some optional embodiments of the present application, the proximal diameter of the stent graft trunk is 32 mm to 45 mm;

[0022] In some optional embodiments of the present application, the distal end diameter of the main tube section is 24 mm to 30 mm.

[0023] In some optional embodiments of the present application, the trunk of the stent graft is conical, and the distal diameter of the trunk of the stent graft is smaller than the proximal diameter of the trunk of the stent graft.

[0024] In some optional embodiments of the present application, the diameter of the distal end of the stent graft trunk differs from the diameter of the proximal end of the stent graft trunk by 6 mm to 8 mm.

[0025] In some optional embodiments of the present application, the integrated stent-type artificial blood vessel further includes:

[0026] The reducing connection part is provided between the main tube section and the stent graft trunk, the proximal end of the reducing connection part is connected to the distal end of the main tube section and the radial size of the first connection part matches, the distal end of the reducing connection part is connected to the proximal end of the stent graft trunk and the radial size of the second connection part matches, and the radial size of the second connection part is larger than the radial size of the first connection part.

[0027] In some optional embodiments of the present application, at least one step is formed on the axial outer peripheral wall of the variable diameter connection portion in the main blood flow direction of the artificial blood vessel.

[0028] In some optional embodiments of the present application, a single short tubular joint is provided, and a single coated short tubular stent is also provided accordingly. The short tubular joint and the coated short tubular stent are connected to form an artificial left common carotid artery branch.

[0029] In some optional embodiments of the present application, the main pipe section is a tubular structure that can be telescopically bent in its own axial direction.

[0030] In some optional embodiments of the present application, the artificial blood vessel portion further includes an artificial brachiocephalic trunk branch and a perfusion branch that are arranged beside the main branch of the artificial blood vessel and communicated with the main branch of the artificial blood vessel.

[0031] In some optional embodiments of the present application, in the main blood flow direction of the artificial blood vessel, the artificial brachiocephalic trunk branch and the perfusion branch are arranged on opposite sides of the main branch of the artificial blood vessel.

[0032] In some optional embodiments of the present application, the axial height of the artificial left common carotid artery branch is greater than the axial height of the left subclavian artery branch.

[0033] In some optional embodiments of the present application, the side short tubular joint includes a first side short tubular joint and a second side short tubular joint, and the coated short tubular stent includes a first coated short tubular stent and a second coated short tubular stent respectively arranged corresponding to the first side short tubular joint and the second side short tubular joint.

[0034] Among them, the first side short tubular joint and the first coated short tubular stent are connected to form an artificial brachiocephalic trunk branch, the second side short tubular joint and the second coated short tubular stent are connected to form an artificial left common carotid artery branch, and the artificial brachiocephalic trunk branch and the artificial left common carotid artery branch are arranged on the same side of the main blood flow direction of the artificial blood vessel.

[0035] In some optional embodiments of the present application, the main pipe section is a tubular structure that can be telescopically bent in its own axial direction.

[0036] In some optional embodiments of the present application, the axial height of the artificial left common carotid artery branch is greater than the axial height of the left subclavian artery branch, and is also greater than the axial height of the artificial brachiocephalic trunk.

[0037] In some optional embodiments of the present application, the first coated short tube stent is a balloon-expandable stent.

[0038] In some optional embodiments of the present application, the artificial blood vessel part is also provided with a spare blood vessel branch, which is arranged on the main branch of the artificial blood vessel and connected to the main branch of the artificial blood vessel. In the main blood flow direction of the artificial blood vessel, the spare blood vessel branch and the artificial brachiocephalic trunk branch are arranged on the same side of the main blood flow direction of the artificial blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 is a schematic diagram of the same type of aortic dissection;

[0040] FIG2 is a schematic diagram of the anatomical structure of the human aorta;

[0041] FIG3 is a schematic diagram of the structure of an integrated stent-type artificial blood vessel provided in one embodiment of the present application;

[0042] FIG4 is a schematic diagram of the structure of an integrated stent-type artificial blood vessel provided in another embodiment of the present application.

[0043] Explanation of Reference Numerals: Artificial Blood Vessel 1; Artificial Blood Vessel Main Branch 11; Perfusion Branch 12; Artificial Brachiocephalic Branch 13; Covered Stent 2; Covered Stent Main Trunk 21; Left Subclavian Artery Branch 22; Covered Short Tubular Stent 23; First Covered Short Tubular Stent 231; Second Covered Short Tubular Stent 232; Flexible Connecting Pipe Segment 3; Main Pipe Segment 31; Parallel Short Tubular Joint 32; First Parallel Short Tubular Joint 321; Second Parallel Short Tubular Joint 322; Anti-Reflux Cap 4; Cap Brim 41; Reducer 5; Proximal End 51 of Reducer 5; Distal End 52 of Reducer 5; Step 53;

[0044] Artificial left common carotid artery branch-6; fixation line-7; anti-reflux coil-8; spare vascular branch-9; main blood flow direction of the artificial blood vessel-X. DETAILED DESCRIPTION

[0045] The technical solution of the present application will be described in detail below with reference to Figures 1 to 4 .

[0046] Figure 1 is a schematic diagram of aortic dissection of the same type. The annual incidence of aortic dissection ranges from 7.9 to 16 per 100,000 person-years. Depending on the location of the rupture, it can be divided into Stanford type A and type B. The incidence of Stanford type A aortic dissection (TAAD) is approximately twice that of Stanford type B aortic dissection (TBAD). If left untreated, the 24-hour mortality rate can reach as high as 50%. For TAAD, current guidelines recommend early open surgical repair of the aortic rupture. However, open surgery often requires a midline thoracotomy and deep hypothermic circulatory arrest. Currently, traditional surgery for type A aortic dissection requires freeing the autologous brachiocephalic trunk branches, left common carotid artery, and left subclavian artery (that is, the above three need to be cut off and then sutured with the implanted artificial blood vessels). Under circulatory arrest, the covered stent is placed into the true lumen of the descending aorta. The covered stent is separated from the four-branch artificial blood vessel (including the main branch of the artificial blood vessel, the artificial brachiocephalic trunk branch, the artificial left carotid artery branch, and the artificial perfusion branch). Therefore, the proximal end of the covered stent needs to be sutured with the distal end of the four-branch artificial blood vessel and the autologous aortic wall. Exposure is difficult, and there is backflow interference during suturing. In addition, the free suture space is limited, which increases the difficulty of anastomosis, thereby prolonging the circulatory arrest time and affecting the protection of brain tissue. In addition, the difficulty of surgical operation can easily lead to the risk of bleeding after anastomosis, prolonging the overall operation time, increasing the extracorporeal circulation time, and being unfavorable for postoperative recovery.

[0047] Figure 2 is a schematic diagram of the human aorta's anatomy. As can be seen from Figure 2, the aorta is primarily arch-shaped, consisting of the ascending and descending aortas, the innominate artery (which connects to the right subclavian artery and right common carotid artery, also known as a branch of the brachiocephalic trunk), the left common carotid artery, and the left subclavian artery, forming the greater curvature of the aortic arch.

[0048] The integrated stent-type artificial blood vessel provided in this application includes:

[0049] The artificial blood vessel portion 1 includes an artificial blood vessel main branch 11, which is used to correspond to the ascending aorta of the human body;

[0050] The stent graft 2 includes a stent graft trunk 21 and a left subclavian artery branch 22 disposed beside the stent graft trunk 21 and communicating with the stent graft trunk 21;

[0051] The flexible connecting pipe section 3 is arranged between the artificial blood vessel part 1 and the coated stent 2. The flexible connecting pipe section 3 includes a main pipe section 31 and a short tubular joint 32 arranged beside the main pipe section 31 and connected to the main pipe section 31. In the main blood flow direction X of the artificial blood vessel, the proximal end of the main pipe section 31 is connected to the main branch 11 of the artificial blood vessel, and the distal end of the main pipe section 31 is connected to the proximal end of the main branch 11 of the artificial blood vessel. The coated short tubular stent 23 is connected to the short tubular joint 32.

[0052] It should be noted that the proximal ends of various structures in the integrated stent-type artificial blood vessel in the embodiment of the present application are the blood inflow ends under normal autologous conditions, and the distal ends of various structures are the blood outflow ends under normal autologous conditions.

[0053] The integrated stent-type artificial blood vessel provided by the present application has an integrated design in which the artificial blood vessel portion 1 and the coated stent 2 are connected. This avoids the problem of difficult exposure caused by the need to suture the proximal end of the coated stent 2 with the distal end of the four-branch artificial blood vessel and the wall of the native aorta. There is no need to anastomose the stent and the artificial blood vessel during surgery, which reduces the anastomosis time and avoids the risk of bleeding at the anastomosis site. The coated stent 2 includes a left subclavian artery branch trunk 22. After the native aorta is cut open in the area between the native left common carotid artery and the native left subclavian artery, the left subclavian artery branch trunk 22 can be inserted into the native left subclavian artery, avoiding the freedom of the native left subclavian artery during surgery and avoiding the need to anastomose a branch of the artificial blood vessel with the native left subclavian artery again, thereby reducing operations and reducing surgical time.

[0054] The integrated stent-type artificial blood vessel provided in the present application is further provided with a flexible connecting pipe section 3, which is arranged between the artificial blood vessel portion 1 and the covered stent 2. The main pipe section 31 on the flexible connecting pipe section 3 is flexible and can well adapt to the curved structure of the human aortic arch.

[0055] Moreover, the short tubular connector 32 on the flexible connecting tube segment 3 and the corresponding coated short tubular stent 23 form an artificial arterial branch that can be directly inserted into the branch artery of the human aorta. Based on the bendability of the main tube segment 31, it can be well adapted to the shape and structure of the arch of the human aorta. The artificial arterial branch (composed of the short tubular connector 32 and the corresponding connected coated short tubular stent 23) can enter the human aorta through the dissected aorta and be directly inserted into the corresponding human arterial branch (for example, the brachiocephalic artery and / or the left common carotid artery), saving the steps required in existing aortic dissection surgery, such as resection of the brachiocephalic artery, the left common carotid artery or the left subclavian artery, freeing and then suturing with the artificial branch blood vessel. In general, the present application provides an integrated stent-type artificial blood vessel with a flexible connector, which can conform to the aortic morphology very well as a whole, avoiding problems such as long-term tearing after surgery. The integrated stent-type artificial blood vessel saves the number of free branch arteries required during surgery, thereby saving free anastomosis time, reducing circulatory arrest time, restoring systemic circulation as soon as possible, enhancing protection of brain tissue, reducing the risk of post-anastomosis bleeding, shortening the overall operation time and extracorporeal circulation time, and facilitating the patient's postoperative recovery.

[0056] [Example 1]

[0057] As shown in FIG3 , the integrated stent-type artificial blood vessel provided by the present application includes:

[0058] The artificial blood vessel portion 1 includes an artificial blood vessel main branch 11, which is used to correspond to the ascending aorta of the human body;

[0059] The stent graft 2 includes a stent graft trunk 21 and a left subclavian artery branch 22 disposed beside the stent graft trunk 21 and communicating with the stent graft trunk 21;

[0060] The flexible connecting pipe section 3 is arranged between the artificial blood vessel part 1 and the coated stent 2. The flexible connecting pipe section 3 includes a main pipe section 31 and a short tubular joint 32 arranged beside the main pipe section 31 and connected to the main pipe section 31. In the main blood flow direction X of the artificial blood vessel, the proximal end of the main pipe section 31 is connected to the main branch 11 of the artificial blood vessel, and the distal end of the main pipe section 31 is connected to the proximal end of the main branch 11 of the artificial blood vessel. The coated short tubular stent 23 is connected to the short tubular joint 32.

[0061] The integrated stent-type artificial blood vessel also includes:

[0062] The anti-reflux cap 4 is arranged around the periphery of the connection between the artificial blood vessel main branch 11 and the main pipe section 31 , and the cap opening of the anti-reflux cap 4 faces the flexible connecting pipe section 3 .

[0063] In some specific examples, the anti-reflux cap 4 and the artificial blood vessel part 1 are made of the same material.

[0064] In some specific examples, the brim 41 of the anti-reflux cap 4 is cylindrical.

[0065] In some specific examples, the brim 41 of the anti-reflux cap 4 is truncated cone-shaped, and the bottom diameter of the brim 41 of the anti-reflux cap 4 close to the main pipe section 31 is larger than the top diameter of the brim 41 of the anti-reflux cap 4 close to the main pipe section 31.

[0066] In some specific examples, the proximal diameter of the stent graft trunk 21 is larger than the distal diameter of the main tube section 31 .

[0067] In some specific examples, the ratio of the proximal diameter of the stent graft trunk 21 to the distal diameter of the main tube section 31 is in the range of 1.06 to 1.9;

[0068] In some specific examples, the proximal diameter of the stent graft trunk 21 is 32 mm to 45 mm;

[0069] In some specific examples, the distal end diameter of the main tube section 31 is 24 mm to 30 mm.

[0070] In some specific examples, the stent graft trunk 21 is cone-shaped, and the distal diameter of the stent graft trunk 21 is smaller than the proximal diameter of the stent graft trunk 21 .

[0071] In some specific examples, the diameter of the distal end of the stent graft trunk 21 differs from the diameter of the proximal end of the stent graft trunk 21 by 6 mm to 8 mm.

[0072] In some specific examples, the integrated stent-type artificial vascular further includes:

[0073] The reducing connection part 5 is arranged between the main tube section 31 and the coated stent trunk 21. The proximal end 51 of the reducing connection part is connected to the distal end of the main tube section 31 and the radial dimension of the first connection matches. The distal end 52 of the reducing connection part 5 is connected to the proximal end of the coated stent trunk 21 and the radial dimension of the second connection matches. The radial dimension of the second connection is larger than the radial dimension of the first connection.

[0074] In some specific examples, in the main blood flow direction X of the artificial blood vessel, at least one step 3 is formed on the axial outer peripheral wall of the diameter-reducing connecting portion 5 .

[0075] In some specific examples, the short side tubular connector 32 is provided singly, and the coated short tubular stent 23 is also provided singly accordingly. The short side tubular connector 32 and the coated short tubular stent 23 are connected to form an artificial left common carotid artery branch 6.

[0076] In some specific examples, the main tube section 31 is a tubular structure that is flexible and retractable in its axial direction. In some examples, the main tube section 31 is integrally formed with the main branch 11 of the artificial blood vessel in the artificial blood vessel portion 1, and both are made of artificial blood vessel materials. In other examples, the main tube section 31 and the main branch 11 of the artificial blood vessel in the artificial blood vessel portion 1 are formed separately and connected by suture.

[0077] In some specific examples, the artificial blood vessel portion 1 further includes an artificial brachiocephalic trunk branch 13 and a perfusion branch 12 which are arranged beside the artificial blood vessel main branch 11 and communicated with the artificial blood vessel main branch 11 .

[0078] In some specific examples, in the main blood flow direction X of the artificial blood vessel, the artificial brachiocephalic trunk branch 13 and the perfusion branch 12 are arranged on opposite sides of the main branch 11 of the artificial blood vessel.

[0079] In some specific treatment scenarios, the integrated stent-type artificial blood vessel provided in Example 1 of the present application is used to treat patients with aortic dissection.

[0080] Routine disinfection and draping were performed, and the internal jugular vein, right dorsalis pedis artery, and radial artery were punctured. The right femoral artery was freed, and the right axillary artery was kept for later use. The thoracotomy was performed, the brachiocephalic artery (i.e., the innominate artery in Figure 2) was freed, and the pericardium was suspended.

[0081] After heparinization, the right femoral and right axillary arteries were selected, and extracorporeal circulation was established with a caesarean cannula. After transfer, cooling was performed, the aorta was clamped, the ascending aorta was dissected, the thrombus was cleared, and the left and right coronary arteries were perfused. The heart was stopped, and the aortic root was treated (if the dissection involved the valve or coronary artery, a David, Bentall, or Wheat procedure was performed first). The aorta was lined with a 1-cm wide graft and secured with 5-0 prolene sutures. The temperature was lowered to 32°C, and an ice cap was applied to the brain. Arrest the circulation and perfuse the brain with 5ml / kg via the right axillary artery. (An assistant has previously prepared this new type of stent-vascular stent and pre-placed three 5-0 prolene sutures equidistantly at the root of the left common carotid artery. Depending on the aorta's morphology, if placement is difficult, a small portion can be cut along the aorta's long axis until the stent placement conditions are met. First, the main trunk of the covered stent 21 is placed, followed by the left subclavian artery branch 22. After complete release, the artificial left common carotid artery branch 6 is placed. The artificial left common carotid artery branch 6 is suspended and fixed to the patient's own aorta with a pre-placed fixing line 7 set on the anti-reflux ring 8. After a short period of circulatory arrest and exhaust, the proximal end of the left common carotid artery branch and the main trunk are blocked with a clamp. Cut the artery longitudinally, restore circulation, suture the longitudinally cut aortic wall (the aortic wall can be sutured and tightened according to the diameter of the stent graft trunk 21 to ensure the fit between the stent graft trunk 21 and the aortic wall), suture the artificial brachiocephalic trunk branch 13 and the free brachiocephalic trunk branch, and the perfusion branch 12 can be used for perfusion. Suture the brim 41 of the anti-reflux cap 4 to the proximal end of the aortic arch continuously. After suturing, pause the circulation briefly to exhaust air, and then move the blocking clamp to the proximal end of the anti-reflux cap 4 for blocking. Restore circulation again. Rewarm, suture the proximal end of the artificial blood vessel main branch 11 to the aortic root continuously (match the valve ring or sinus tube junction). Restart the heart, check for bleeding, give additional injections, remove the machine, and close the chest as usual.

[0082] During the operation, due to the bending performance of the flexible connecting tube section 3, the stent graft 2 can be quickly inserted first and then the entire artificial blood vessel part 1 can be inserted, reducing the need to free the branch arteries connected to the side of the aorta (such as the brachiocephalic artery, the left carotid artery and the left subclavian artery). The insertion time of the integrated stent-type artificial blood vessel is greatly improved, and the circulation can be quickly restored. The conical setting of the stent graft trunk 21 conforms to the structure of the human aorta, and the proximal end of the stent graft trunk 21 is more in line with the diameter of the aorta, fits well with the aortic wall, and reduces false lumen reflux.

[0083] The design of the anti-reflux cap 4: on the one hand, it can block the backflow of blood from the false lumen of the dissection; on the other hand, the setting of the anti-reflux cap 4 can increase the suture area with the native aortic wall, thereby increasing the space for anastomosis operation and reducing the difficulty of anastomosis. The anti-reflux cap 4 is used to anastomose with the aortic wall to avoid the general direct ligation and binding of the artificial blood vessel and the covered stent 2 to the aortic wall, which leads to aortic compression ischemia and necrosis, thereby avoiding long-term necrosis and detachment of the aortic wall and improving the patient's quality of life after surgery. The design of the anti-reflux cap 4 greatly simplifies the processing steps and processing time of the anastomosis between the integrated stent-type artificial blood vessel and the aortic arch, and can make the proximal blockade of the anti-reflux cap 4 restore the systemic circulation as soon as possible, thereby achieving multiple circulatory arrest times, enhancing the protection of brain tissue, reducing the risk of post-anastomotic bleeding, shortening the overall operation time and extracorporeal circulation time, and facilitating the patient's postoperative recovery.

[0084] The left subclavian artery branch trunk 22 has a high degree of fit with the patient's own left subclavian artery and can also play an anti-reflux role.

[0085] The axial height of the artificial left common carotid artery branch trunk 6 is greater than the axial height of the left subclavian artery branch trunk 22. Considering that the proximal end of the left common carotid artery has no branches, designing the artificial left common carotid artery branch trunk 6 with a higher axial height can increase the anti-reflux effect of the stent anchor area. In addition, the root of the artificial left common carotid artery branch trunk 6 (i.e., the proximal end where the short tubular connector is connected to the main tube section 31) is designed with an anti-reflux coil 8 to further reduce reflux. The multiple fixed lines 7 (in some examples, three sutures) pre-installed on the root anti-reflux coil can be used for fixation when the angle of the artificial left common carotid artery branch trunk 6 deviates from the human left common carotid artery, preventing the artificial blood vessel from twisting and narrowing during subsequent use, which seriously affects the blood supply of the left common carotid artery. The pre-installed fixed line 7 can prevent dissection from tearing the left common carotid artery.

[0086] The provision of the flexible connecting tube section 3 can facilitate the folding of the integrated stent-type artificial blood vessel, is beneficial to the preservation of the integrated stent-type artificial blood vessel and facilitates the priority release of the artificial left subclavian artery branch 22, further facilitates the implantation of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13 and further leaves sufficient space for the above two to match with the human autologous branch artery, further improves the matching degree between the relative position and angle of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13 and the relative position and angle of the common carotid artery and the brachiocephalic artery in the actual individual, improves the fault tolerance of the integrated stent-type artificial blood vessel and the human body's own aortic structure differences, and improves the compatibility of the integrated stent-type artificial blood vessel with more patients.

[0087] The design of the anti-reflux ring can further reduce reflux bleeding. When the reflux bleeding is severe, it is convenient to sew the artificial blood vessels and autologous blood vessels from the outside.

[0088] The artificial blood vessel main branch 11 and main tube section 31 have relatively small diameters, ensuring that the artificial blood vessel main branch 11 meets the requirements for matching the valve annulus or sinus junction, while the proximal diameter of the covered stent main trunk 21 needs to be increased to limit false lumen regurgitation. The provision of step 3 on the reducer 5 satisfies the different diameter requirements of the proximal end 51 and distal end 52 of the reducer 5. Based on the principle that the flow rate slows as the cross-sectional area of ​​blood flowing through increases, and the principle of blocking false lumen regurgitation, the provision of step 3 can limit and mitigate false lumen regurgitation.

[0089] The transition step 3 from the stent graft trunk 21 to the main tube segment 31: This design avoids the limitation of the stent graft trunk 21 diameter due to the proximal diameter requirement of the graft portion 1, which could prevent the stent graft trunk 21 from being matched with a suitable stent graft trunk 21 at the distal aortic arch to limit false lumen regurgitation. This design allows the selection of a proximal graft trunk 11 and main tube segment 31 with a suitable diameter, without limiting the stent graft trunk 21 diameter, thus better preventing false lumen regurgitation.

[0090] [Example 2]

[0091] As shown in FIG4 , the difference between this embodiment 2 and the above embodiment 1 is that:

[0092] The side short tubular joint 32 includes a first side short tubular joint 321 and a second side short tubular joint 322. The coated short tubular stent 23 includes a first coated short tubular stent 231 and a second coated short tubular stent 232 respectively arranged corresponding to the first side short tubular joint 321 and the second side short tubular joint 322.

[0093] Among them, the first side short tubular joint 321 and the first coated short tubular stent 231 are connected to form an artificial brachiocephalic trunk branch 13, and the second side short tubular joint 322 and the second coated short tubular stent 232 are connected to form an artificial left common carotid artery branch. The artificial brachiocephalic trunk branch 13 and the artificial left common carotid artery branch are arranged on the same side of the main blood flow direction X of the artificial blood vessel.

[0094] The main pipe section 31 is a tubular structure that is telescopically bendable in its own axial direction.

[0095] In some optional embodiments of the present application, the first coated short tube stent 231 is a balloon-expandable stent.

[0096] In some optional embodiments of the present application, the artificial blood vessel part 1 is also provided with a spare blood vessel branch 9, which is arranged on the main branch 11 of the artificial blood vessel and is connected to the main branch 11 of the artificial blood vessel. In the main blood flow direction X of the artificial blood vessel, the spare blood vessel branch 9 and the artificial brachiocephalic trunk branch 13 are arranged on the same side of the main blood flow direction X of the artificial blood vessel.

[0097] In some specific treatment scenarios, the integrated stent-type artificial blood vessel provided in Example 1 of the present application is used to treat patients with aortic dissection.

[0098] Routine disinfection and draping were performed. The internal jugular vein, right dorsalis pedis artery, and radial artery were punctured, and the right femoral artery was freed. The right axillary artery was reserved for later use. The thoracotomy was then performed, and a portion of the brachiocephalic artery (i.e., the innominate artery in Figure 2) was freed. The pericardium was suspended. The brachiocephalic artery was occluded at this point to prevent blood perfused from the axillary artery cannulation from flowing back into the aorta, rendering the procedure inoperable. The brachiocephalic artery was superficial and easy to free, and only a portion of the vessel was freed for vascular occlusion.

[0099] After heparinization, the right femoral artery and right axillary artery are selected, and extracorporeal circulation is established with a caesarean cannula. After the machine is switched, the temperature is lowered in parallel, the aorta is blocked, the ascending aorta is opened, the thrombus is cleared, the left and right coronary arteries are perfused, and the heart is stopped. If the dissection involves the valve or coronary artery, David, Bentall or wheat surgery is required first, the temperature is lowered to 32°C, and an ice cap is applied to the brain. The circulation is stopped, and the brain is perfused with 5ml / kg through the right axillary artery. (Before this, the assistant prepares the integrated stent-type artificial blood vessel provided in this embodiment in advance, and pre-places 3 5-0 prolene sutures at the root of the left common carotid artery. Depending on the morphology of the aorta, if the placement is difficult, a small part can be cut along the long axis of the aorta until the conditions for stent placement are met. First, the covered stent main trunk 21 is placed, and then the left subclavian artery branch trunk 22 is placed. After complete release, the artificial left common carotid artery branch trunk 6 is placed, and the artificial left common carotid artery branch trunk 6 is suspended and fixed to the patient's own body with the fixed line 7 pre-placed on the anti-reflux ring 8. On the aorta. After a brief pause in circulation and venting, the blocking clamp is used to block the proximal end of the autologous left common carotid artery branch and the longitudinal incision of the aorta, the circulation is restored, the brachiocephalic trunk branch is inserted, and the balloon is used to expand the brachiocephalic trunk to fit well with the brachiocephalic trunk to avoid backflow of blood. The longitudinally cut aortic wall is sutured (the aortic wall can be sutured and tightened according to the diameter of the artificial blood vessel to ensure the fit between the artificial blood vessel and the aortic wall), the brim 41 of the anti-reflux cap 4 is sutured continuously with the proximal end of the aortic arch, and the circulation is restored again after venting. Rewarming, the proximal end of the main branch 11 of the artificial blood vessel is sutured continuously with the aortic root. The heart is restarted, bleeding is checked, the needle is added, the machine is removed, and the chest is closed as usual.

[0100] After implantation, first covered short-tube stent 231 is a balloon-expandable stent (e.g., the Gore VBX covered stent 2). This balloon-expandable stent can be expanded according to the diameter of the brachiocephalic artery (innominate artery), ensuring a complete fit between the first covered short-tube stent 231 and the brachiocephalic artery to prevent reflux. A balloon of appropriate diameter is selected for balloon expansion. Three 5-0 prolene fixation sutures 7 (i.e., the sutures 7 pre-installed on the anti-reflux coil 8) at the base of the artificial brachiocephalic branch 13 are sutured and secured to the native brachiocephalic artery. In these examples, the first coated short tube stent 231 is a balloon-expandable stent. Due to the different anatomical morphologies and distribution angles of the three branches of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery in the aortic arch, an integrated stent-type artificial blood vessel is generally first implanted from the left subclavian artery. When the artificial brachiocephalic artery is subsequently implanted, in order to improve the universality of the integrated stent-type artificial blood vessel to the aortas of patients with different aortic dissections, a balloon-expandable stent is used to enable the artificial brachiocephalic branch 13 to have a larger range of movement angles to adapt to the brachiocephalic arteries on different human aortas. After the artificial brachiocephalic branch 13 is adapted to the angles of the brachiocephalic arteries on different human aortas, a suitable balloon is selected according to the diameter for balloon expansion to adapt the diameters of the two.

[0101] In other examples, if the angle deviation of the artificial brachiocephalic trunk branch 13 when it is implanted into the person's own artificial brachiocephalic artery is large, the first side short tubular connector 321 and the first coated short tubular stent 231 are connected to form the artificial brachiocephalic trunk branch 13, which is ligated and discarded, and the spare vascular branch 9 is used to be implanted into the person's own artificial brachiocephalic artery.

[0102] The brim 41 of the anti-reflux cap 4 is continuously sutured to the proximal end of the aortic arch. After suturing, the circulation is briefly paused to allow for ventilation, and the clamp is then moved to the proximal end of the anti-reflux cap 4 for occlusion. Circulation is restored. Rewarming is performed, and the proximal end of the main branch of the artificial blood vessel 11 is continuously sutured to the aortic root (aligning the annulus or sinus-tubular junction). The heart is re-beaten, bleeding is checked, additional stitches are given, the ventilator is removed, and the chest is closed as usual.

[0103] During the operation, due to the bending performance of the flexible connecting tube section 3, the stent graft 2 can be quickly inserted first and then the entire artificial blood vessel part 1 can be inserted, reducing the need to free the branch arteries connected to the side of the aorta (such as the brachiocephalic artery, the left carotid artery and the left subclavian artery). The insertion time of the integrated stent-type artificial blood vessel is greatly improved, and the circulation can be quickly restored. The conical setting of the stent graft trunk 21 conforms to the structure of the human aorta, and the proximal end of the stent graft trunk 21 is more in line with the diameter of the aorta, fits well with the aortic wall, and reduces false lumen reflux.

[0104] The design of the anti-reflux cap 4: on the one hand, it can block the backflow of blood from the false lumen of the dissection; on the other hand, the setting of the anti-reflux cap 4 can increase the suture area with the native aortic wall, thereby increasing the space for anastomosis operation and reducing the difficulty of anastomosis. The anti-reflux cap 4 is used to anastomose with the aortic wall to avoid the compression of the aortic wall when the artificial blood vessel and the covered stent 2 are directly sutured to the aortic wall, thereby avoiding long-term necrosis and detachment of the aortic wall and improving the patient's quality of life after surgery. The design of the anti-reflux cap 4 greatly simplifies the processing steps and processing time of the anastomosis between the integrated stent-type artificial blood vessel and the aortic arch, and can make the proximal blockade of the anti-reflux cap 4 restore the systemic circulation as soon as possible, thereby achieving multiple circulatory arrest times, enhancing the protection of brain tissue, reducing the risk of bleeding after anastomosis, shortening the overall operation time and extracorporeal circulation time, and facilitating the patient's postoperative recovery.

[0105] The left subclavian artery branch trunk 22 has a high degree of fit with the patient's own left subclavian artery and can also play an anti-reflux role.

[0106] The axial height of the artificial left common carotid artery branch trunk 6 is greater than the axial height of the left subclavian artery branch trunk 22. The axial height of the artificial left common carotid artery branch trunk 6 is also greater than the axial height of the artificial brachiocephalic trunk 13. Considering that there are no branches at the proximal end of the left common carotid artery, designing the artificial left common carotid artery branch trunk 6 to have a higher axial height can increase the anti-reflux effect of the stent anchor area. In addition, the root of the artificial left common carotid artery branch trunk 6 (i.e., the proximal end where the short tubular connector is connected to the main pipe section 31) is designed with an anti-reflux coil 8 to further reduce the reflux situation. The multiple fixed lines 7 (in some examples, three sutures) pre-installed on the root anti-reflux coil can be used for fixation when the angle of the artificial left common carotid artery branch trunk 6 deviates from the human left common carotid artery, so as to prevent the artificial blood vessel from twisting and narrowing during subsequent use, which seriously affects the blood supply of the left common carotid artery. The pre-installed fixed line 7 can prevent the dissection from tearing the left common carotid artery in reverse.

[0107] The provision of the flexible connecting tube section 3 can facilitate the folding of the integrated stent-type artificial blood vessel, is beneficial to the preservation of the integrated stent-type artificial blood vessel and facilitates the priority release of the artificial left subclavian artery branch 22, further facilitates the implantation of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13 and further leaves sufficient space for the above two to match with the human autologous branch artery, further improves the matching degree between the relative position and angle of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13 and the relative position and angle of the common carotid artery and the brachiocephalic artery in the actual individual, improves the fault tolerance of the integrated stent-type artificial blood vessel and the human body's own aortic structure differences, and improves the compatibility of the integrated stent-type artificial blood vessel with more patients.

[0108] The design of the anti-reflux ring can further reduce reflux bleeding. When the reflux bleeding is severe, it is convenient to sew the artificial blood vessels and autologous blood vessels from the outside.

[0109] The variable diameter connection part 5 is provided with a step 3 to ensure that the artificial blood vessel main branch 11 meets the needs and matches the valve ring or sinus tube junction. The artificial blood vessel main branch 11 has a smaller diameter, and avoids the inability to match a suitable stent at the distal end of the aortic arch to limit the false lumen reflux of the artificial blood vessel main branch 11.

[0110] The transition step from the main stent to the graft (3 sections): This design avoids the problem of limiting stent diameter selection due to proximal graft diameter requirements, which can prevent false lumen regurgitation in the distal aortic arch. This design allows for the selection of a proximal graft with an appropriate diameter without limiting the diameter of the main stent graft (2), thereby better preventing false lumen regurgitation.

[0111] In general, the current traditional surgical procedures for aortic dissection, especially the existing surgical procedures for type A aortic dissection, require the brachiocephalic artery, left common carotid artery and left subclavian artery to be freed, and the covered stent and the four-branch artificial blood vessel are set separately, all of which lead to long circulatory arrest time and easy reflux. The integrated stent-type artificial blood vessel provided in the embodiment of the present application greatly reduces the required free branch arteries in aortic dissection surgery, especially type A aortic dissection surgery, avoids the risk of bleeding during anastomosis, and has a high degree of compatibility with the human aorta. The use of the integrated stent-type artificial blood vessel provided in the embodiment of the present application can revolutionize the current traditional surgical procedures for type A aortic dissection. It greatly reduces the operation time, simplifies the operation, improves the success rate of the operation, and expands the number of high-risk patients who cannot tolerate surgery.

[0112] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. An integrated stent-type artificial blood vessel, characterized in that: include: The artificial blood vessel portion includes an artificial blood vessel main branch, wherein the artificial blood vessel main branch is configured to correspond to the ascending aorta of the human body; The stent graft comprises a stent graft trunk and a left subclavian artery branch arranged beside the stent graft trunk and communicating with the stent graft trunk; A flexible connecting pipe segment is arranged between the artificial blood vessel part and the coated stent. The flexible connecting pipe segment includes a main pipe segment and a short side tubular joint arranged beside the main pipe segment and connected to the main pipe segment. In the main blood flow direction of the artificial blood vessel, the proximal end of the main pipe segment is connected to the main branch of the artificial blood vessel, and the distal end of the main pipe segment is connected to the proximal end of the main branch of the artificial blood vessel. The coated short tubular stent is connected to the short side tubular joint.

2. The integrated stent-type artificial blood vessel according to claim 1, characterized in that: Also includes: an anti-reflux cap, arranged around the periphery of the connection between the main branch of the artificial blood vessel and the main pipe section, with the cap opening of the anti-reflux cap facing the flexible connecting pipe section; Preferably, the anti-reflux cap and the artificial blood vessel portion are made of the same material; Preferably, the brim of the anti-reflux cap is cylindrical; Preferably, the brim of the anti-reflux cap is truncated cone-shaped, and the diameter of the bottom end of the brim of the anti-reflux cap close to the main pipe section is larger than the diameter of the top end of the brim of the anti-reflux cap close to the main pipe section.

3. The integrated stent-type artificial blood vessel according to claim 1, characterized in that: The proximal diameter of the stent graft trunk is larger than the distal diameter of the main tube section; Preferably, the ratio of the proximal diameter of the stent graft trunk to the distal diameter of the main tube section is in the range of 1.06 to 1.9; Preferably, the proximal diameter of the stent graft trunk is 32 mm to 45 mm; Preferably, the distal end diameter of the main pipe section is 24 mm to 30 mm.

4. The integrated stent-type artificial blood vessel according to claim 3, characterized in that: The stent graft trunk is cone-shaped, and the distal diameter of the stent graft trunk is smaller than the proximal diameter of the stent graft trunk; Preferably, the diameter of the distal end of the stent graft trunk differs from the diameter of the proximal end of the stent graft trunk by 6 mm to 8 mm.

5. The integrated stent-type artificial blood vessel according to claim 4, characterized in that: The integrated stent-type artificial blood vessel further comprises: A reducing connection portion is arranged between the main tube section and the coated stent trunk, the proximal end of the reducing connection portion is connected to the distal end of the main tube section and the radial dimension of the first connection matches, the distal end of the reducing connection portion is connected to the proximal end of the coated stent trunk and the radial dimension of the second connection matches, and the radial dimension of the second connection is larger than the radial dimension of the first connection.

6. The integrated stent-type artificial blood vessel according to claim 5, characterized in that: In the main blood flow direction of the artificial blood vessel, at least one step is formed on the axial outer peripheral wall of the variable diameter connection part.

7. The integrated stent-type artificial vascular according to any one of claims 1 to 6, characterized in that: The short tubular joint is provided in single piece, and the coated short tubular stent is also provided in single piece accordingly. The short tubular joint and the coated short tubular stent are connected to form an artificial left common carotid artery branch trunk; Preferably, the main pipe section is a tubular structure that is telescopically bendable in its own axial direction; Preferably, the axial height of the artificial left common carotid artery branch is greater than the axial height of the left subclavian artery branch.

8. The integrated stent-type artificial blood vessel according to claim 7, characterized in that: The artificial blood vessel portion further includes an artificial brachiocephalic trunk branch and a perfusion branch disposed beside the main branch of the artificial blood vessel and communicating with the main branch of the artificial blood vessel; Preferably, in the main blood flow direction of the artificial blood vessel, the artificial brachiocephalic trunk branch and the perfusion branch are arranged on opposite sides of the main branch of the artificial blood vessel.

9. The integrated stent-type artificial vascular according to any one of claims 1 to 6, characterized in that: The side short tubular joint includes a first side short tubular joint and a second side short tubular joint, and the coated short tubular stent includes a first coated short tubular stent and a second coated short tubular stent respectively arranged corresponding to the first side short tubular joint and the second side short tubular joint. The first short tubular joint and the first covered short tubular stent are connected to form an artificial brachiocephalic trunk branch, the second short tubular joint and the second covered short tubular stent are connected to form an artificial left common carotid artery branch, and the artificial brachiocephalic trunk branch and the artificial left common carotid artery branch are arranged on the same side of the main blood flow direction of the artificial blood vessel; Preferably, the first coated short tube stent is a balloon expandable stent; Preferably, the artificial blood vessel portion is further provided with a spare blood vessel branch, which is provided on the main branch of the artificial blood vessel and is connected to the main branch of the artificial blood vessel. In the main blood flow direction of the artificial blood vessel, the spare blood vessel branch and the artificial brachiocephalic trunk branch are provided on the same side in the main blood flow direction of the artificial blood vessel; Preferably, the main pipe section is a tubular structure that is telescopically bendable in its own axial direction; Preferably, the axial height of the artificial left common carotid artery branch is greater than the axial height of the left subclavian artery branch, and is also greater than the axial height of the artificial brachiocephalic trunk.

10. The integrated stent-type artificial blood vessel according to claim 7 or 9, characterized in that: The proximal periphery of the short tubular joint connected to the main pipe section is provided with an anti-reflux ring; Preferably, a plurality of fixed lines are preset on the anti-reflux ring along its circumference.

Images