Integrated stent-type artificial blood vessel

Abstract

The application provides an integrated stent type artificial blood vessel, which comprises an artificial blood vessel part, a covered stent and a bendable connecting pipe section. The artificial blood vessel part comprises an artificial blood vessel main stem which is arranged to correspond to the ascending aorta of a human body. The covered stent comprises a covered stent main stem and a left subclavian artery branch stem which is arranged on the side of the covered stent main stem and is communicated with the covered stent main stem. The bendable connecting pipe section is arranged between the artificial blood vessel part and the covered stent, and comprises a main pipe section and a side short pipe joint which is arranged on the side of the main pipe section and is communicated with 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 with the artificial blood vessel main stem, the distal end of the main pipe section is connected with the proximal end of the artificial blood vessel main stem, and a covered short pipe type stent is connected on the side short pipe joint. The integrated stent type artificial blood vessel saves the number of branch arteries which need to be separated during the operation, thereby saving the separation and anastomosis time, reducing the time of stopping circulation, enhancing the protection of brain tissue and being beneficial to the postoperative rehabilitation of the patient.

Description

Technical Field

[0001] This application relates to the field of artificial blood vessel medical device technology, and in particular to an integrated stent-type artificial blood vessel. Background Technology

[0002] Currently, traditional aortic dissection surgery requires the freeing of the brachiocephalic trunk branches, the left common carotid artery, and the left subclavian artery. A covered stent is then placed into the true lumen of the descending aorta while circulation is stopped. The covered stent is placed separately from the four-branch prosthetic vessel, requiring the proximal end of the covered stent to be sutured to the distal end of the four-branch prosthetic vessel and the autologous aortic wall. This exposure is difficult, and backflow during suturing can cause interference. Furthermore, the limited space for free suturing increases the difficulty of anastomosis, leading to prolonged circulation stoppage time, affecting the protection of brain tissue. The difficult surgical procedure also increases the risk of post-anastomosis hemorrhage, prolonging the overall surgical time, increasing cardiopulmonary bypass time, and hindering postoperative recovery. Summary of the Invention

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

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

[0005] The covered stent includes the covered stent trunk and a branch of the left subclavian artery located beside the covered stent trunk and communicating with the covered stent trunk;

[0006] A flexible connecting tube segment is disposed between the artificial blood vessel and the covered stent. The flexible connecting tube segment includes a main tube segment and a side short tubular connector disposed beside the main tube segment and communicating with the main tube segment. In the main blood flow direction of the artificial blood vessel, the proximal end of the main tube segment is connected to the main branch of the artificial blood vessel, and the distal end of the main tube segment is connected to the proximal end of the main branch of the artificial blood vessel. A covered short tubular stent is connected to the side short tubular connector.

[0007] The integrated stent-type artificial blood vessel provided in this application features an integrated design connecting the artificial blood vessel portion and the covered stent. This avoids the difficulty of exposure caused by suturing the proximal end of the covered stent to the distal end of the four-branch artificial blood vessel and the autologous aortic wall. It eliminates the need for intraoperative anastomosis between the stent and the artificial blood vessel, reducing anastomosis time and avoiding the risk of bleeding at the anastomosis site. The covered stent includes a branch of the left subclavian artery. After incising the area between the autologous aorta and the autologous left common carotid artery, the branch of the left subclavian artery can be placed into the autologous left subclavian artery. This avoids the dislodgement of the autologous left subclavian artery during surgery and also avoids re-anastomosing a branch of the artificial blood vessel to the autologous left subclavian artery, reducing the procedure time.

[0008] The integrated stent-type artificial blood vessel provided in this application also includes a flexible connecting tube segment. The flexible connecting tube segment is disposed between the artificial blood vessel and the covered stent. The main tube segment of the flexible connecting tube segment is flexible and can well adapt to the curved structure of the arch of the human aorta.

[0009] Furthermore, the flexible connecting segment with its adjacent short tubular connector and corresponding covered short tubular stent forms an artificial arterial branch that can be directly inserted into a branch artery of the human aorta. Based on the flexibility of the main segment, it can well adapt to the shape and structure of the curved portion of the human aorta. The artificial arterial branch (composed of the adjacent short tubular connector and the corresponding covered short tubular stent) can enter the human aorta through the dissected aorta and be directly inserted into the corresponding human arterial branch (e.g., the brachiocephalic trunk and / or the left common carotid artery), saving the steps required in existing aortic dissection surgeries, such as the resection, freeing, and suturing of the brachiocephalic trunk, left common carotid artery, or left subclavian artery to the artificial branch vessel. In summary, this application provides an integrated stent-type artificial blood vessel with a flexible connector, which conforms very well to the aortic morphology, avoiding problems such as aortic wall necrosis and rupture caused by postoperative binding and ligation. Integrated stent-type artificial blood vessels reduce the number of branch arteries that need to be dissected during surgery, thereby saving dissection and anastomosis time, reducing circulatory arrest time, restoring systemic circulation as early as possible, enhancing protection of brain tissue, reducing the risk of post-anastomosis bleeding, shortening the overall operation time and cardiopulmonary bypass time, and facilitating postoperative recovery for patients.

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

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

[0012] The covered stent includes the covered stent trunk and a branch of the left subclavian artery located beside the covered stent trunk and communicating with the covered stent trunk;

[0013] A flexible connecting tube segment is disposed between the artificial blood vessel and the covered stent. The flexible connecting tube segment includes a main tube segment and a side short tubular connector disposed beside the main tube segment and communicating with the main tube segment. In the main blood flow direction of the artificial blood vessel, the proximal end of the main tube segment is connected to the main branch of the artificial blood vessel, and the distal end of the main tube segment is connected to the proximal end of the main branch of the artificial blood vessel. A covered short tubular stent is connected to the side short tubular connector.

[0014] In some optional embodiments of this application, it further includes:

[0015] An anti-reflux cap is placed around the periphery of the connection between the main branch and the main tube of the artificial blood vessel, with the cap opening facing the flexible connecting tube section.

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

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

[0018] In some optional embodiments of this application, the brim of the anti-backflow cap is frustum-shaped, and the diameter of the bottom end of the brim of the anti-backflow cap near the main pipe section is larger than the diameter of the top end of the brim of the anti-backflow cap near the main pipe section.

[0019] In some optional embodiments of this application, the proximal diameter of the covered stent trunk is larger than the distal diameter of the main tube segment.

[0020] In some optional embodiments of this application, the ratio of the proximal diameter of the main trunk of the covered stent to the distal diameter of the main tube segment ranges from 1.06 to 1.9.

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

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

[0023] In some optional embodiments of this application, the main trunk of the covered stent is conical in shape, and the distal diameter of the main trunk is smaller than the proximal diameter of the main trunk.

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

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

[0026] A variable-diameter connector is disposed between the main pipe section and the main trunk of the covered stent. The proximal end of the variable-diameter connector is connected to the distal end of the main pipe section, and the radial dimensions of the first connection match. The distal end of the variable-diameter connector is connected to the proximal end of the main trunk of the covered stent, and the radial dimensions of the second connection match. The radial dimension of the second connection is greater than that of the first connection.

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

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

[0029] In some optional embodiments of this application, the main pipe section is a tubular structure that is axially flexible and malleable.

[0030] In some optional embodiments of this application, the artificial blood vessel section further includes an artificial brachiocephalic trunk branch and a perfusion branch disposed beside and connected to the main branch of the artificial blood vessel.

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

[0032] In some optional embodiments of this 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 this application, the side short tubular connector includes a first side short tubular connector and a second side short tubular connector, and the covered short tubular stent includes a first covered short tubular stent and a second covered short tubular stent respectively corresponding to the first side short tubular connector and the second side short tubular connector.

[0034] The first lateral short tubular connector and the first covered short tubular stent are connected to form an artificial brachiocephalic trunk branch, and the second lateral short tubular connector and the second covered short tubular stent are connected to form an artificial left common carotid artery branch. The artificial brachiocephalic trunk branch and the artificial left common carotid artery branch are set on the same side in the main blood flow direction of the artificial blood vessel.

[0035] In some optional embodiments of this application, the main pipe section is a tubular structure that is axially flexible and malleable.

[0036] In some optional embodiments of this 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 also greater than the axial height of the artificial brachiocephalic trunk branch.

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

[0038] In some optional embodiments of this application, the artificial blood vessel is further provided with a spare blood vessel branch. The spare blood vessel branch is located 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 located on the same side in the main blood flow direction of the artificial blood vessel. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of a similar type of aortic dissection;

[0040] Figure 2 A schematic diagram of the anatomical structure of the human aorta;

[0041] Figure 3This is a schematic diagram of an integrated stent-type artificial blood vessel structure provided in one embodiment of this application;

[0042] Figure 4 This is a schematic diagram of an integrated stent-type artificial blood vessel structure provided in another embodiment of this application.

[0043] Explanation of reference numerals in the attached figures:

[0044] Artificial blood vessel section-1; Artificial blood vessel main branch-11; Perfusion branch-12; Artificial brachiocephalic trunk branch-13;

[0045] Covered stent-2; Covered stent trunk-21; Left subclavian artery branch-22; Covered short tube stent-23; First covered short tube stent-231; Second covered short tube stent-232;

[0046] Flexible connecting pipe section-3; main pipe section-31; side short tubular joint-32; first side short tubular joint-321; second side short tubular joint-322;

[0047] Anti-reverse flow cap-4; brim-41;

[0048] Variable diameter connecting part -5; Proximal end of variable diameter connecting part -51; Distal end of variable diameter connecting part -52; Step -53;

[0049] Artificial left common carotid artery branch -6;

[0050] 7. Fixed suture; 8. Anti-reflux coil; 9. Spare vascular branch;

[0051] The main blood flow direction of artificial blood vessels is X. Detailed Implementation

[0052] The following will be combined with the appendix Figures 1 to 4 The technical solution of this application is described in detail.

[0053] Figure 1This is a schematic diagram of aortic dissection of the same type. The annual incidence of aortic dissection is 7.9 / 100,000 person-years to 16 / 100,000 person-years. Depending on the location of the tear, 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), and without timely treatment, the 24-hour mortality rate is as high as 50%. For TAAD, current guidelines recommend early open surgery to repair the torn aorta. However, open surgery often requires median thoracotomy and deep hypothermic circulatory arrest. Currently, traditional surgery for type A aortic dissection requires the freeing of the autologous brachiocephalic trunk branches, the left common carotid artery, and the left subclavian artery (i.e., these three need to be cut and then anastomosed with the implanted artificial blood vessel by suturing). During circulatory arrest, a covered stent is placed into the true lumen of the descending aorta. The covered stent and 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) are set up separately. 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, which makes exposure difficult. There is backflow interference during suturing, and the space for free suturing is limited, which increases the difficulty of anastomosis, thus prolonging the circulatory arrest time, affecting the protection of brain tissue, and the difficult surgical operation increases the risk of post-anastomosis hemorrhage, prolonging the overall operation time, increasing the cardiopulmonary bypass time, and hindering postoperative recovery.

[0054] Figure 2 This is a schematic diagram of the anatomical structure of the human aorta. From... Figure 2 It can be seen that the aorta is mainly arched. The aorta includes the ascending aorta and the descending aorta. The brachiocephalic artery (which connects to the right subclavian artery and the right common carotid artery, and can also be called a branch of the brachiocephalic trunk), the left common carotid artery, and the left subclavian artery are formed on the greater curvature side of the aortic arch.

[0055] The integrated stent-type artificial blood vessel provided in this application includes:

[0056] The artificial blood vessel section 1 includes an artificial blood vessel main branch 11, which is used to correspond to the human ascending aorta.

[0057] Covered stent 2 includes a covered stent trunk 21 and a left subclavian artery branch 22 located beside the covered stent trunk 21 and communicating with the covered stent trunk 21;

[0058] A flexible connecting tube segment 3 is disposed between the artificial blood vessel section 1 and the covered stent 2. The flexible connecting tube segment 3 includes a main tube segment 31 and a side short tubular connector 32 disposed beside the main tube segment 31 and communicating with the main tube segment 31. In the main blood flow direction X of the artificial blood vessel, the proximal end of the main tube segment 31 is connected to the main branch 11 of the artificial blood vessel, and the distal end of the main tube segment 31 is connected to the proximal end of the main branch 11 of the artificial blood vessel. A covered short tubular stent 23 is connected to the side short tubular connector 32.

[0059] It should be noted that, in the integrated stent-type artificial blood vessel embodiments of this application, the proximal ends of various structures 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.

[0060] The integrated stent-type artificial blood vessel provided in this application features an integrated design where the artificial blood vessel portion 1 and the covered stent 2 are connected. This avoids the difficulty of exposure caused by suturing the proximal end of the covered stent 2 to the distal end of the four-branch artificial blood vessel and the autologous aortic wall. It eliminates the need for intraoperative anastomosis between the stent and the artificial blood vessel, reducing anastomosis time and avoiding the risk of bleeding at the anastomosis site. The covered stent 2 includes a branch 22 of the left subclavian artery. After incising the region between the autologous aorta and the autologous left common carotid artery, the branch 22 of the left subclavian artery can be placed into the autologous left subclavian artery. This avoids the dislodgement of the autologous left subclavian artery during surgery and also avoids re-anastomosing a branch of the artificial blood vessel to the autologous left subclavian artery, reducing the procedure time.

[0061] The integrated stent-type artificial blood vessel provided in this application is also provided with a flexible connecting tube segment 3. The flexible connecting tube segment 3 is disposed between the artificial blood vessel part 1 and the covered stent 2. The main tube segment 31 on the flexible connecting tube segment 3 is flexible and can well adapt to the curved structure of the arch of the human aorta.

[0062] Furthermore, the flexible connecting segment 3, with its side short tubular connector 32 and corresponding covered short tubular stent 23, forms an artificial arterial branch that can be directly inserted into a branch artery of the human aorta. Based on the flexibility of the main segment 31, it can well adapt to the shape and structure of the curved portion of the human aorta. The artificial arterial branch (composed of the side short tubular connector 32 and the corresponding covered short tubular stent 23) can enter the human aorta through the dissected aorta and be directly inserted into the corresponding human arterial branch (e.g., the brachiocephalic trunk and / or the left common carotid artery), saving the steps required in existing aortic dissection surgeries, such as the resection, freeing, and suturing of the brachiocephalic trunk, left common carotid artery, or left subclavian artery to the artificial branch vessel. In summary, this application provides an integrated stent-type artificial blood vessel with a flexible connector, which conforms very well to the aortic morphology, avoiding problems such as long-term postoperative tearing. Integrated stent-type artificial blood vessels reduce the number of branch arteries that need to be dissected during surgery, thereby saving dissection and anastomosis time, reducing circulatory arrest time, restoring systemic circulation as early as possible, enhancing protection of brain tissue, reducing the risk of post-anastomosis bleeding, shortening the overall operation time and cardiopulmonary bypass time, and facilitating postoperative recovery for patients.

[0063]

Example 1

[0064] like Figure 3 As shown, the integrated stent-type artificial blood vessel provided in this application includes:

[0065] The artificial blood vessel section 1 includes an artificial blood vessel main branch 11, which is used to correspond to the human ascending aorta.

[0066] Covered stent 2 includes a covered stent trunk 21 and a left subclavian artery branch 22 located beside the covered stent trunk 21 and communicating with the covered stent trunk 21;

[0067] A flexible connecting tube segment 3 is disposed between the artificial blood vessel section 1 and the covered stent 2. The flexible connecting tube segment 3 includes a main tube segment 31 and a side short tubular connector 32 disposed beside the main tube segment 31 and communicating with the main tube segment 31. In the main blood flow direction X of the artificial blood vessel, the proximal end of the main tube segment 31 is connected to the main branch 11 of the artificial blood vessel, and the distal end of the main tube segment 31 is connected to the proximal end of the main branch 11 of the artificial blood vessel. A covered short tubular stent 23 is connected to the side short tubular connector 32.

[0068] Integrated stent-type artificial blood vessels also include:

[0069] An anti-reflux cap 4 is placed around the outer periphery of the connection between the main branch 11 and the main tube section 31 of the artificial blood vessel, with the cap opening facing the flexible connecting tube section 3.

[0070] In some specific examples, the anti-reflux cap 4 and the artificial blood vessel section 1 are made of the same material.

[0071] In some specific examples, the brim 41 of the anti-reverse flow cap 4 is cylindrical.

[0072] In some specific examples, the brim 41 of the anti-backflow cap 4 is truncated cone-shaped, and the diameter of the bottom end of the brim 41 near the main pipe section 31 is larger than the diameter of the top end of the brim 41 near the main pipe section 31.

[0073] In some specific examples, the proximal diameter of the covered stent trunk 21 is larger than the distal diameter of the main tube segment 31.

[0074] In some specific examples, the ratio of the proximal diameter of the main trunk 21 to the distal diameter of the main tube 31 ranges from 1.06 to 1.9.

[0075] In some specific examples, the proximal diameter of the covered stent trunk 21 is 32 mm to 45 mm;

[0076] In some specific examples, the distal diameter of the main section 31 is 24mm to 30mm.

[0077] In some specific examples, the covered stent trunk 21 is conical in shape, and the distal diameter of the covered stent trunk 21 is smaller than the proximal diameter of the covered stent trunk 21.

[0078] In some specific examples, the distal diameter of the covered stent trunk 21 differs from the proximal diameter of the covered stent trunk 21 by 6 mm to 8 mm.

[0079] In some specific examples, integrated stent-type artificial blood vessels also include:

[0080] A variable diameter connecting part 5 is disposed between the main pipe section 31 and the main body of the covered support 21. The proximal end 51 of the variable diameter connecting part is connected to the distal end of the main pipe section 31 and the radial dimensions of the first connection are matched. The distal end 52 of the variable diameter connecting part 5 is connected to the proximal end of the main body of the covered support 21 and the radial dimensions of the second connection are matched. The radial dimension of the second connection is greater than the radial dimension of the first connection.

[0081] In some specific examples, in the main blood flow direction X of the artificial blood vessel, the outer peripheral wall of the variable diameter connection 5 is formed with at least one step 3.

[0082] In some specific examples, a single para-short tubular connector 32 is provided, and a single covered short tubular stent 23 is also provided accordingly. The para-short tubular connector 32 and the covered short tubular stent 23 are connected to form an artificial left common carotid artery branch 6.

[0083] In some specific examples, the main pipe section 31 is a tubular structure that can extend and bend along its own axis. In some examples, the main pipe section 31 and the main branch of the artificial blood vessel in the artificial blood vessel section 1 are integrally formed and both are made of artificial blood vessel material. In other examples, the main pipe section 31 and the main branch of the artificial blood vessel in the artificial blood vessel section 1 are formed separately and connected by suturing.

[0084] In some specific examples, the artificial blood vessel section 1 also includes an artificial brachiocephalic trunk branch 13 and a perfusion branch 12 located beside and connected to the main branch 11 of the artificial blood vessel.

[0085] In some specific examples, the artificial brachiocephalic trunk branch 13 and the perfusion branch 12 are located on opposite sides of the main branch 11 of the artificial blood vessel in the main blood flow direction X.

[0086] In some specific treatment scenarios, the integrated stent-type artificial blood vessel provided in Embodiment 1 of this application is used to treat patients with aortic dissection.

[0087] Routine disinfection and draping; puncture the internal jugular vein, right dorsalis pedis artery and radial artery; free the right femoral artery and right axillary artery for later use; open the chest; free the brachiocephalic trunk (i.e., Figure 2 (The unnamed artery in the heart) suspends the pericardium.

[0088] After heparinization, the right femoral artery and right axillary artery were selected, and cardiopulmonary bypass was established via atrial cannula. After cardiopulmonary bypass, cooling was performed concurrently. The aorta was clamped, the ascending aorta was opened, thrombi were cleared, and both coronary arteries were perfused. The heart was stopped, and the aortic root was treated (if the dissection involved the valves or coronary arteries, a David, Bentall, or wheat procedure was required first). A 1cm wide artificial vascular graft was placed inside the aorta and fixed with 5-0 prolene sutures. Cooling was reduced to 32°C, and an ice cap was applied to the brain. Circulation was stopped, and the brain was perfused with 5 ml / kg via the right axillary artery. (Previously, the assistant prepared this new type of stent vessel in advance, pre-placed three 5-0 Prolene sutures at equal intervals at the root of the left common carotid artery. Depending on the aortic morphology, if placement was difficult, a small section could be cut along the long axis of the aorta until the conditions for stent placement were met. First, the covered stent trunk 21 was placed, followed by the left subclavian artery branch trunk 22. After complete release, the artificial left common carotid artery branch trunk 6 was placed. The artificial left common carotid artery branch trunk 6 was suspended and fixed to the patient's own aorta using the fixation suture 7 pre-placed on the anti-reflux coil 8. After a brief pause in circulation and degassing, the proximal end of the left common carotid artery branch and the main aorta were blocked with clamps.) The aortic wall is longitudinally incised to restore circulation. The longitudinally incised aortic wall is sutured (the aortic wall can be tightened according to the diameter of the covered stent trunk 21 to ensure proper fit between the covered stent trunk 21 and the aortic wall). The artificial brachiocephalic trunk branch 13 is sutured to the free brachiocephalic trunk branch. The perfusion branch 12 can be used for perfusion. The brim 41 of the anti-reflux cap 4 is continuously sutured to the proximal end of the aortic arch. After suturing, circulation is briefly paused to expel air, and the clamp is moved to the proximal end of the anti-reflux cap 4 for occlusion. Circulation is restored again. The patient is rewarmed, and the proximal end of the artificial blood vessel main branch 11 is continuously sutured to the aortic root (matching the valve annulus or sinus duct junction). The heart restarts, bleeding is checked, sutures are applied, the ventilator is weaned off, and the chest is closed routinely.

[0089] During the procedure, the flexible connecting segment 3 allows for rapid placement of the covered stent 2 followed by the entire artificial blood vessel 1, reducing the need to dissect and connect branch arteries adjacent to the aorta (such as the brachiocephalic trunk, left carotid artery, and left subclavian artery). This significantly improves the placement time of the integrated stent-type artificial blood vessel, enabling rapid restoration of circulation. The tapered design of the covered stent trunk 21 conforms to the structure of the human aorta, with the proximal end of the covered stent trunk 21 closely conforming to the aortic diameter and adhering well to the aortic wall, reducing false lumen reflux.

[0090] The design of the anti-reflux cap 4 serves two purposes: firstly, it seals the false lumen of the dissection and prevents backflow of blood; secondly, its placement increases the suture area with the autologous aortic wall, thus increasing the anastomosis space and reducing anastomosis difficulties. Using the anti-reflux cap 4 for anastomosis with the aortic wall avoids the common practice of directly ligating and binding the artificial blood vessel and covered stent 2 to the aortic wall, which can lead to aortic compression, ischemia, and necrosis. This prevents long-term aortic wall necrosis and detachment, improving the patient's postoperative quality of life. The design of the anti-reflux cap 4 greatly simplifies the handling steps and time of the integrated stent-type artificial blood vessel anastomosis with the aortic arch. It allows for earlier restoration of systemic circulation through proximal occlusion of the anti-reflux cap 4, enabling multiple stages of circulatory arrest, enhancing protection of brain tissue, reducing the risk of post-anastomosis hemorrhage, shortening the overall operation time and cardiopulmonary bypass time, and facilitating postoperative recovery.

[0091] The left subclavian artery branch 22 has a high degree of compatibility with the patient's own left subclavian artery, which can also play a role in preventing reflux.

[0092] The axial height of the artificial left common carotid artery branch 6 is greater than that of the left subclavian artery branch 22. Considering the lack of branching in the proximal left common carotid artery, designing a higher axial height for the artificial left common carotid artery branch 6 can enhance the anti-reflux effect at the stent anchor point. Furthermore, an anti-reflux coil 8 is designed at the root of the artificial left common carotid artery branch 6 (i.e., the proximal end where the short tubular connector connects to the main tube segment 31) to further reduce reflux. Pre-installed multi-strand fixation sutures 7 (in some examples, three sutures) on the root anti-reflux coil can be used for fixation when there is an angular deviation between the artificial left common carotid artery branch 6 and the patient's own left common carotid artery, preventing the artificial blood vessel from twisting and narrowing during subsequent use, which could severely affect the blood supply to the left common carotid artery. The pre-installed fixation sutures 7 can prevent retrograde dissection of the left common carotid artery.

[0093] The flexible connecting tube segment 3 facilitates the folding of the integrated stent-type artificial blood vessel, which is beneficial for its preservation and allows for the priority release of the artificial left subclavian artery branch 22. Furthermore, it facilitates the insertion of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13, and provides sufficient space for matching these two with the patient's own branch arteries. This 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 brachiocephalic trunk in the actual individual, increases the tolerance of the integrated stent-type artificial blood vessel to the differences in the structure of the human aorta, and improves the compatibility of the integrated stent-type artificial blood vessel with more patients.

[0094] The design of the anti-reflux coil can further reduce reflux bleeding, and in cases of severe reflux bleeding, it is convenient to add needles from the outside to suture the artificial blood vessel and autologous blood vessel.

[0095] The artificial blood vessel main branch 11 and main tube segment 31 have relatively small diameters to ensure that the artificial blood vessel main branch 11 meets the requirements for matching with the valve annulus or sinus duct junction. However, the proximal diameter of the covered stent main branch 21 needs to be increased to limit false lumen reflux. The step 3 of the variable diameter connector 5 effectively meets the different diameter requirements of the proximal 51 and distal 52 of the variable diameter connector 5. Based on the principle that the flow velocity decreases as the cross-sectional area of ​​the flowing blood increases and the principle of blocking false lumen reflux, the step 3 can limit and slow down the false lumen reflux.

[0096] The transition step from the covered stent trunk 21 to the main tube segment 31 consists of three parts: This design avoids limiting the selection of the covered stent trunk 21 diameter due to the requirement of the proximal diameter of the prosthetic vessel section 1, thus preventing the inability to match a suitable covered stent trunk 21 distal to the aortic arch and limiting false lumen regurgitation. This design allows for the selection of a suitable diameter proximal prosthetic vessel branch 11 and main tube segment 31 without limiting the selection of the covered stent trunk 21 diameter, thereby better preventing false lumen regurgitation.

[0097]

Example 2

[0098] like Figure 4 As shown, the difference between this embodiment 2 and the above embodiment 1 is that:

[0099] The side short tubular connector 32 includes a first side short tubular connector 321 and a second side short tubular connector 322. The covered short tubular stent 23 includes a first covered short tubular stent 231 and a second covered short tubular stent 232 respectively corresponding to the first side short tubular connector 321 and the second side short tubular connector 322.

[0100] The first lateral short tubular connector 321 and the first covered short tubular stent 231 are connected to form an artificial brachiocephalic trunk branch 13, and the second lateral short tubular connector 322 and the second covered 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 set on the same side in the main blood flow direction X of the artificial blood vessel.

[0101] The main section 31 has a tubular structure that can be stretched and bent along its own axis.

[0102] In some optional embodiments of this application, the first covered short tube stent 231 is a balloon-expandable stent.

[0103] In some optional embodiments of this application, the artificial blood vessel section 1 is further provided with a spare blood vessel branch 9. The spare blood vessel branch 9 is disposed on the main branch 11 of the artificial blood vessel and communicates with 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 disposed on the same side in the main blood flow direction X of the artificial blood vessel.

[0104] In some specific treatment scenarios, the integrated stent-type artificial blood vessel provided in Embodiment 1 of this application is used to treat patients with aortic dissection.

[0105] Routine disinfection and draping; puncture the internal jugular vein, right dorsalis pedis artery and radial artery; free the right femoral artery and right axillary artery for later use; open the chest; free part of the brachiocephalic trunk (i.e. Figure 2 The brachiocephalic trunk (infranametical artery) is used to suspend the pericardium. This is because the brachiocephalic trunk needs to be blocked here to prevent backflow of blood from the axillary artery during cannulation into the aorta, which would make the surgery impossible. The brachiocephalic trunk is superficial and easily dissected here, and only a portion of the vessel is dissected for vascular occlusion.

[0106] After heparinization, the right femoral artery and right axillary artery were selected, and cardiopulmonary bypass was established using an atrial cannula. After cardiopulmonary bypass, the patient was simultaneously cooled, the aorta was blocked, the ascending aorta was opened, thrombi were cleared, and both coronary arteries were perfused. The heart was stopped. If the dissection involved the valves or coronary arteries, a David, Bentall, or Wheat procedure was required first. The patient was cooled to 32°C, and an ice cap was applied to the brain. Circulation was stopped, and the brain was perfused with 5 ml / kg via the right axillary artery. (Previously, the assistant prepared the integrated stent-type artificial blood vessel provided in this embodiment. Three 5-0 prolene sutures were pre-placed at the root of the left common carotid artery. Depending on the aortic morphology, if placement was difficult, a small section could be cut along the long axis of the aorta until the conditions for stent placement were met. First, the covered stent trunk 21 was placed, followed by the left subclavian artery branch trunk 22. After complete release, the artificial left common carotid artery branch trunk 6 was placed. The artificial left common carotid artery branch trunk 6 was suspended and fixed to the patient's own body using a fixation suture 7 pre-placed on the anti-reflux coil 8.) Above the aorta. After a brief pause in circulation and venting, the proximal branch of the autologous left common carotid artery and the longitudinally incised portion of the aorta are blocked with clamps. Circulation is restored, and a branch of the brachiocephalic trunk is inserted. A balloon is used for dilation to ensure proper apposition to the brachiocephalic trunk and prevent backflow. The longitudinally incised aortic wall is sutured (the aortic wall can be tightened according to the diameter of the artificial blood vessel to ensure proper apposition between the artificial blood vessel and the aortic wall). The brim 41 of the anti-reflux cap 4 is continuously sutured to the proximal end of the aortic arch. After venting, circulation is restored again. Rewarming is performed, and the proximal end of the main branch 11 of the artificial blood vessel is continuously sutured to the aortic root. The heart restarts, bleeding is checked, additional sutures are applied, the machine is weaned off, and the chest is closed routinely.

[0107] The first covered short-tube stent 231 is a balloon-expandable stent (e.g., the Gore VBX covered stent 2). After placement, balloon dilation can be performed according to the diameter of the brachiocephalic trunk (innominate artery) to ensure complete adhesion between the first covered short-tube stent 231 and the brachiocephalic trunk, preventing backflow. A balloon of appropriate diameter is selected for balloon dilation, and the three pre-placed 5-0 prolene sutures 7 (i.e., the sutures 7 pre-installed on the anti-reflux coil 8) at the root of the artificial brachiocephalic trunk branch 13 are sutured and fixed to the patient's own brachiocephalic trunk. In these examples, the first covered short-tube stent 231 is a balloon-expandable stent. Due to the different anatomical morphology, distribution position and angle of the three branches of the brachiocephalic trunk, left common carotid artery and left subclavian artery in the aortic arch, the integrated stent-type artificial blood vessel is generally first placed from the left subclavian artery. When the artificial brachiocephalic trunk is placed subsequently, in order to improve the universality of the integrated stent-type artificial blood vessel for the aorta of different patients with aortic dissection, a balloon-expandable stent is used. This allows the artificial brachiocephalic trunk branch 13 to have a large range of movement angles to adapt to the upper brachiocephalic trunk of different human aortas. After the angle of the artificial brachiocephalic trunk branch 13 is adapted to the upper brachiocephalic trunk of different human aortas, an appropriate balloon is selected according to the diameter for balloon expansion, so that the diameters of the two are adapted.

[0108] In other cases, if the angle deviation of the artificial brachiocephalic trunk branch 13 when it is inserted into the human's own artificial brachiocephalic trunk artery is large, the first lateral short tubular connector 321 and the first covered short tubular stent 231 are connected to form the artificial brachiocephalic trunk branch 13, which is then ligated and discarded, and a spare vascular branch 9 is inserted into the human's own artificial brachiocephalic trunk artery.

[0109] The brim 41 of the anti-reflux cap 4 is continuously sutured to the proximal end of the aortic arch. After suturing, circulation is briefly paused and air is expelled. The clamp is then moved to the proximal end of the anti-reflux cap 4 for occlusion. Circulation is restored. The patient is rewarmed, and the proximal end of the main branch of the artificial blood vessel 11 is continuously sutured to the aortic root (matching the valve annulus or sinus duct junction). The heart restarts, bleeding is checked, additional sutures are applied, the ventilator is weaned off, and the chest is closed routinely.

[0110] During the procedure, the flexible connecting segment 3 allows for rapid placement of the covered stent 2 followed by the entire artificial blood vessel 1, reducing the need to dissect and connect branch arteries adjacent to the aorta (such as the brachiocephalic trunk, left carotid artery, and left subclavian artery). This significantly improves the placement time of the integrated stent-type artificial blood vessel, enabling rapid restoration of circulation. The tapered design of the covered stent trunk 21 conforms to the structure of the human aorta, with the proximal end of the covered stent trunk 21 closely conforming to the aortic diameter and adhering well to the aortic wall, reducing false lumen reflux.

[0111] The design of the anti-reflux cap 4 serves two purposes: firstly, it seals the false lumen of the dissection and prevents backflow of blood; secondly, its placement increases the suture area with the autologous aortic wall, thus increasing the anastomosis space and reducing anastomosis difficulties. Using the anti-reflux cap 4 for anastomosis with the aortic wall avoids the compression of the aortic wall that occurs when the artificial blood vessel and covered stent 2 are directly sutured to the aortic wall, thereby preventing long-term aortic wall necrosis and detachment and improving the patient's postoperative quality of life. The design of the anti-reflux cap 4 greatly simplifies the handling steps and time of the integrated stent-type artificial blood vessel anastomosis with the aortic arch, allowing for earlier restoration of systemic circulation through proximal occlusion of the anti-reflux cap 4, enabling multiple stages of circulatory arrest, enhancing protection of brain tissue, reducing the risk of post-anastomosis hemorrhage, shortening the overall operation time and cardiopulmonary bypass time, and facilitating postoperative recovery.

[0112] The left subclavian artery branch 22 has a high degree of compatibility with the patient's own left subclavian artery, which can also play a role in preventing reflux.

[0113] The axial height of the artificial left common carotid artery branch 6 is greater than that of the left subclavian artery branch 22, and also greater than that of the artificial brachiocephalic trunk branch 13. Considering the lack of branches in the proximal left common carotid artery, designing a higher axial height for the artificial left common carotid artery branch 6 can enhance the anti-reflux effect at the stent anchor point. Furthermore, an anti-reflux coil 8 is designed at the root of the artificial left common carotid artery branch 6 (i.e., the proximal end where the short tubular connector connects to the main tube segment 31) to further reduce reflux. Pre-installed multi-strand fixation sutures 7 (in some examples, three sutures) on the root anti-reflux coil can be used for fixation when there is an angular deviation between the artificial left common carotid artery branch 6 and the patient's own left common carotid artery, preventing the artificial blood vessel from twisting and narrowing during subsequent use, which could severely affect the blood supply to the left common carotid artery. The pre-installed fixation sutures 7 can also prevent retrograde dissection of the left common carotid artery.

[0114] The flexible connecting tube segment 3 facilitates the folding of the integrated stent-type artificial blood vessel, which is beneficial for its preservation and allows for the priority release of the artificial left subclavian artery branch 22. Furthermore, it facilitates the insertion of the artificial left common carotid artery branch 6 and the artificial brachiocephalic trunk branch 13, and provides sufficient space for matching these two with the patient's own branch arteries. This 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 brachiocephalic trunk in the actual individual, increases the tolerance of the integrated stent-type artificial blood vessel to the differences in the structure of the human aorta, and improves the compatibility of the integrated stent-type artificial blood vessel with more patients.

[0115] The anti-reflux coil design can further reduce reflux bleeding, and in cases of severe reflux bleeding, it facilitates external suturing of artificial and autologous blood vessels.

[0116] The variable diameter connecting part 5 is provided with a step 3 to ensure that the main branch of the artificial blood vessel 11 meets the requirements and matches the junction of the valve ring or sinus duct. The main branch of the artificial blood vessel 11 has a small diameter, which avoids the inability to match a suitable stent at the distal end of the aortic arch to limit the false lumen regurgitation of the main branch of the artificial blood vessel 11.

[0117] The three-part transition step from the main stent to the artificial blood vessel avoids limiting the choice of stent diameter due to the requirements of the proximal artificial blood vessel diameter, thus preventing the inability to match a suitable stent distal to the aortic arch and limiting false lumen regurgitation. This design allows for the selection of an artificial blood vessel of a suitable diameter proximally and does not restrict the choice of the diameter of the main covered stent 2, thereby better avoiding false lumen regurgitation.

[0118] In summary, current traditional surgical procedures for aortic dissection, especially for type A aortic dissection, require the freeing of the brachiocephalic trunk, left common carotid artery, and left subclavian artery, with the covered stent and four-branch artificial blood vessel placed separately. This results in prolonged circulatory arrest and a high risk of reflux. However, the integrated stent-type artificial blood vessel provided in this application significantly reduces the number of branch arteries that need to be freed in aortic dissection surgery, especially for type A aortic dissection, avoiding the bleeding risk associated with anastomosis. The integrated stent-type artificial blood vessel also exhibits high compatibility with the human aorta. Using the integrated stent-type artificial blood vessel provided in this application can fundamentally change the current surgical procedures for type A aortic dissection. It greatly reduces surgical time, simplifies the procedure, improves the success rate, and expands the pool of high-risk patients who cannot tolerate surgery.

[0119] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. An integrated stent-type artificial blood vessel, characterized in that, include: The artificial blood vessel section includes a main branch of the artificial blood vessel, which is configured to correspond to the human ascending aorta. A covered stent includes a covered stent trunk and a branch of the left subclavian artery located beside and communicating with the covered stent trunk; A flexible connecting tube segment is disposed between the artificial blood vessel and the covered stent. The flexible connecting tube segment includes a main tube segment and a side short tubular connector disposed beside the main tube segment and communicating with the main tube segment. In the main blood flow direction of the artificial blood vessel, the proximal end of the main tube segment is connected to the main branch of the artificial blood vessel, and the distal end of the main tube segment is connected to the proximal end of the main branch of the covered stent. A covered short tubular stent is connected to the side short tubular connector. The proximal diameter of the main trunk of the covered stent is larger than the distal diameter of the main tube segment. The integrated stent-type artificial blood vessel also includes: A variable-diameter connector is disposed between the main pipe section and the main trunk of the covered stent. The proximal end of the variable-diameter connector is connected to the distal end of the main pipe section and the radial dimensions of the first connection point are matched. The distal end of the variable-diameter connector is connected to the proximal end of the main trunk of the covered stent and the radial dimensions of the second connection point are matched. The radial dimension of the second connection point is greater than the radial dimension of the first connection point.

2. The integrated stent-type artificial blood vessel according to claim 1, characterized in that, Also includes: An anti-reflux cap is disposed around the outer periphery of the connection between the main branch of the artificial blood vessel and the main tube segment, with the cap opening facing the flexible connecting tube segment.

3. The integrated stent-type artificial blood vessel according to claim 2, characterized in that, The anti-reflux cap and the artificial blood vessel are made of the same material.

4. The integrated stent-type artificial blood vessel according to claim 2, characterized in that, The brim of the anti-backflow cap is cylindrical.

5. The integrated stent-type artificial blood vessel according to claim 2, characterized in that, The brim of the anti-backflow cap is truncated cone-shaped, and the diameter of the brim of the anti-backflow cap near the bottom end of the main pipe section is larger than the diameter of the brim of the anti-backflow cap near the top end of the main pipe section.

6. The integrated stent-type artificial blood vessel according to claim 1, characterized in that, The ratio of the proximal diameter of the main trunk of the covered stent to the distal diameter of the main tube segment ranges from 1.06 to 1.

9.

7. The integrated stent-type artificial blood vessel according to claim 6, characterized in that, The proximal diameter of the main trunk of the covered stent is 32mm to 45mm.

8. The integrated stent-type artificial blood vessel according to claim 6, characterized in that, The distal diameter of the main pipe section is 24mm to 30mm.

9. The integrated stent-type artificial blood vessel according to claim 1, characterized in that, The main trunk of the covered stent is conical in shape, and the distal diameter of the main trunk is smaller than the proximal diameter of the main trunk.

10. The integrated stent-type artificial blood vessel according to claim 9, characterized in that, The distal diameter of the covered stent trunk differs from the proximal diameter by 6 mm to 8 mm.

11. The integrated stent-type artificial blood vessel according to claim 1, characterized in that, In the main blood flow direction of the artificial blood vessel, the outer peripheral wall of the variable diameter connection part has at least one step.

12. The integrated stent-type artificial blood vessel according to any one of claims 1 to 11, characterized in that, The lateral short tubular connector is provided individually, and the covered short tubular stent is also provided individually. The lateral short tubular connector and the covered short tubular stent are connected to form an artificial left common carotid artery branch.

13. The integrated stent-type artificial blood vessel according to claim 12, characterized in that, The main pipe section is a tubular structure that can extend and bend along its own axis.

14. The integrated stent-type artificial blood vessel according to claim 13, characterized in that, The axial height of the artificial left common carotid artery branch is greater than the axial height of the left subclavian artery branch.

15. The integrated stent-type artificial blood vessel according to claim 12, characterized in that, The artificial blood vessel section also includes an artificial brachiocephalic trunk branch and a perfusion branch located beside and connected to the main branch of the artificial blood vessel.

16. The integrated stent-type artificial blood vessel according to claim 15, characterized in that, In the main blood flow direction of the artificial blood vessel, the artificial brachiocephalic trunk branch and the perfusion branch are located on opposite sides of the main branch of the artificial blood vessel.

17. The integrated stent-type artificial blood vessel according to any one of claims 1 to 11, characterized in that, The side short tubular connector includes a first side short tubular connector and a second side short tubular connector, and the membrane-covered short tubular stent includes a first membrane-covered short tubular stent and a second membrane-covered short tubular stent respectively corresponding to the first side short tubular connector and the second side short tubular connector. The first lateral short tubular connector and the first covered short tubular stent are connected to form an artificial brachiocephalic trunk branch, and the second lateral short tubular connector and the second covered short tubular stent are connected to form an artificial left common carotid artery branch. The artificial brachiocephalic trunk branch and the artificial left common carotid artery branch are located on the same side in the main blood flow direction of the artificial blood vessel.

18. The integrated stent-type artificial blood vessel according to claim 17, characterized in that, The first covered short tube stent is a balloon-expandable stent; The artificial blood vessel section is also provided with a spare blood vessel branch. The spare blood vessel branch is located 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 located on the same side in the main blood flow direction of the artificial blood vessel. The main pipe section is a tubular structure that can extend and bend along its own axis; The axial height of the artificial left common carotid artery branch is greater than that of the left subclavian artery branch, and also greater than that of the artificial brachiocephalic trunk branch.

19. The integrated stent-type artificial blood vessel according to claim 1, characterized in that, An anti-backflow ring is fitted around the near end of the short tubular connector that connects to the main pipe section, and multiple fixed wires are pre-installed on the anti-backflow ring along its circumference.

Images