Double-multi-leaf balloon sheathing canal for aorta sequential in-situ fenestration

Abstract

The invention provides a double-multi-leaf balloon sheathing canal for aorta sequential in-situ fenestration, which comprises a sheathing canal main body, a near-end balloon, a far-end balloon and an operating handle, and a working channel is arranged in the sheathing canal main body; the near-end balloon comprises a plurality of near-end lobule-dividing balloons, the plurality of near-end lobule-dividing balloons are arranged around the sheathing canal main body at intervals, and a near-end blood flow channel is arranged between every two adjacent near-end lobule-dividing balloons; the far-end balloon comprises a plurality of far-end lobule-dividing balloons, the far-end lobule-dividing balloons are arranged around the sheathing canal body at intervals, a far-end blood flow channel is arranged between every two adjacent far-end lobule-dividing balloons, and the far-end balloons are arranged close to the far end of the sheathing canal body relative to the near-end balloon. On the premise that aorta blood flow is not completely blocked, puncture windowing operation is stably, accurately and efficiently completed.

Description

Technical Field

[0001] The present invention relates to the technical field of sheath tubes, and in particular to a double-leaflet balloon sheath tube for antegrade in situ fenestration of the aorta. Background Art

[0002] In the treatment of aortic lesions involving visceral branch vessels (such as abdominal aortic aneurysm and aortic dissection), when the lesions involve important branch arteries such as the renal arteries and superior mesenteric artery, preserving blood flow in these arteries is crucial for maintaining organ function and postoperative recovery. In situ fenestration technology, a key approach to addressing this issue, allows for on-site puncture and creation of a puncture hole within an implanted standard covered stent, restoring blood flow in the branch arteries. This technique is particularly suitable for emergency situations, such as those requiring emergency care.

[0003] The emergence of specialized needle fenestration devices is a significant step in the development of in situ fenestration technology. Devices such as Futhrough (aortic stent graft rupture system) and Quick Fenestrater (endoluminal controllable rupture system) are specifically optimized for in situ fenestration. These devices typically consist of a guide sheath and a core needle. Futhrough, for example, incorporates a coaxial, non-compliant positioning balloon positioned near the tip of the puncture needle. Once the device reaches the target location, the balloon is inflated, pressing it against the contralateral aortic wall and providing reverse support for the puncture needle, thereby achieving a relatively stable puncture procedure.

[0004] However, existing specialized acupuncture fenestration devices still have many significant drawbacks in practical applications: 1. Poor stability: Although supported by a coaxial balloon, it is difficult to maintain coaxiality and perpendicularity between the device and the target vessel opening when faced with complex anatomical structures such as tortuosity and angulation of the aorta. During antegrade fenestration, the tip is prone to deviation, leading to puncture direction deviation and increased risk of failure. This requires multiple attempts, prolongs the procedure, and increases patient pain and risk.

[0005] 2. Serious blood flow blockage: The positioning balloon must be inflated to a large diameter to provide sufficient support, which can completely or partially block aortic blood flow. When treating lesions involving branches of vital organs such as the renal artery, prolonged ischemia of distal limbs and internal organs can cause irreversible damage, severely impacting postoperative recovery, compressing the surgical window, and increasing surgical difficulty and stress.

[0006] 3. Difficulty in positioning during antegrade fenestration: When performing antegrade fenestration from the aortic lumen to the outside, the opening of the covered branch artery cannot be directly observed, making positioning difficult. In complex conditions such as aortic torsion and calcification, it is difficult to adjust the puncture needle to the ideal vertical angle, resulting in a high puncture failure rate or prolonged time, inefficient surgery, and increased risk. Summary of the Invention

[0007] The purpose of the present invention is to address the deficiencies in the existing technology and provide a double-leaflet balloon sheath for in situ antegrade aortic fenestration. Without completely blocking the aortic blood flow, the puncture and fenestration operation can be completed stably, accurately and efficiently, thereby improving the success rate of the operation, reducing the risk of complications such as intraoperative ischemia, and providing patients with a safer and more effective treatment method.

[0008] In order to achieve the above object, the present invention provides the following technical solutions: A double-leaflet balloon sheath for antegrade in situ aortic fenestration, comprising: a sheath body, wherein a working channel is provided in the sheath body; A proximal balloon, comprising a plurality of proximal lobed balloons, the plurality of proximal lobed balloons being spaced apart around the sheath body, with proximal blood flow channels being provided between adjacent proximal lobed balloons; A distal balloon, comprising a plurality of distal lobed balloons, the plurality of distal lobed balloons being spaced apart around the sheath body, with distal blood flow channels being provided between adjacent distal lobed balloons, the distal balloon being disposed adjacent to the distal end of the sheath body relative to the proximal balloon; An operating handle connected to the proximal end of the sheath body, the operating handle being provided with: A main channel interface, the main channel interface being in communication with the working channel; a proximal filling port, the proximal filling port being in communication with the proximal balloon; A distal filling port is communicated with the distal balloon.

[0009] As a preferred embodiment, the plurality of proximal lobed balloons are arranged circumferentially about the center line of the sheath body.

[0010] As a preferred embodiment, the distal balloon has a distal centerline, and the plurality of distal lobed balloons are arranged circumferentially around the distal centerline, and the distal centerline is offset from the centerline of the sheath body.

[0011] As a preferred embodiment, the sheath tube body is provided with: a proximal filling cavity, the proximal filling cavity communicating with the proximal filling port and the proximal balloon; A distal filling cavity is connected to the distal filling port and the distal balloon.

[0012] As a preferred embodiment, the proximal balloon further comprises: The proximal tube is used for connecting the two ends of the proximal lobed balloon to the sheath body.

[0013] As a preferred embodiment, the distal balloon further comprises: The distal tube is used for connecting the two ends of the distal lobed balloon to the sheath body.

[0014] As a preferred embodiment, a puncture side hole is opened on the outer wall of the sheath body, and the puncture side hole communicates with the working channel and the outside.

[0015] As a preferred embodiment, the puncture side hole is located between the proximal balloon and the distal balloon.

[0016] As a preferred embodiment, the proximal balloon and the distal balloon are provided with developing rings.

[0017] As a preferred embodiment, the operating handle is further provided with a three-way pipe, and the three-way pipe is connected to the working channel.

[0018] As a preferred embodiment, it also includes: A dilator is inserted into the working channel.

[0019] Compared with the existing technology, this technical solution has the following advantages: The proximal balloon and the distal balloon are both designed to abut against the blood vessel wall at multiple points through multiple lobed balloons, providing stable support for the sheath body, effectively preventing slipping or displacement during puncture, and reducing the risk of blood vessel damage.

[0020] The blood flow channel design between the lobed balloons preserves the blood flow in the aorta, avoids ischemia of organs and limbs, and reduces complications caused by ischemia.

[0021] First, the distal end of the sheath is initially positioned by the distal balloon, and then fine-tuning and secondary stabilization are achieved by controlling the filling of the proximal balloon, providing double-balloon combined and stable support for the entire sheath. This combined design greatly improves the positioning accuracy and adaptability to different anatomical conditions.

[0022] A puncture side hole is provided on the side wall of the sheath body, and the puncture side hole is located between the proximal balloon and the distal balloon. The puncture side hole can naturally face the target blood vessel wall. When the puncture needle drills out of the puncture side hole, it can perform puncture at an ideal angle close to 90°, which simplifies the operation, reduces the requirement for the operator to bend the sheath angle, and improves the success rate and safety of antegrade puncture.

[0023] Since the instrument stability and positioning issues are effectively solved, the puncture process becomes more direct and controllable, reducing the number of repeated attempts and adjustments, thereby shortening the operation time, reducing the amount of contrast agent used and X-ray radiation exposure. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1This is a schematic diagram of the uninflated double-leaflet balloon sheath for antegrade in situ aortic fenestration according to the present invention; Figure 2 Schematic diagram of inflation of the double multi-leaflet balloon sheath for antegrade in situ aortic fenestration according to the present invention; Figure 3 This is a schematic diagram of the uninflated proximal balloon of the present invention; Figure 4 Schematic diagram of the inflation of the proximal balloon of the present invention; Figure 5 This is a schematic diagram of the distal balloon of the present invention when it is not inflated; Figure 6 Schematic diagram of inflation of the distal balloon of the present invention; Figure 7 This is a schematic diagram of the puncture side hole structure on the sheath tube body of the present invention; Figure 8 A schematic diagram of a connector of the expander according to the present invention; Figure 9 This is a schematic diagram of the assembly of the dilator and the sheath body of the present invention.

[0025] In the figure: 100 sheath body, 110 working channel, 120 puncture side hole, 200 proximal balloon, 210 proximal lobed balloon, 220 proximal blood flow channel, 230 proximal tube, 300 distal balloon, 310 distal lobed balloon, 320 distal blood flow channel, 330 distal tube, 400 operating handle, 410 main channel interface, 420 proximal filling port, 430 distal filling port, 440 three-way tube, 500 developing ring, 600 dilator. DETAILED DESCRIPTION

[0026] The following description is intended to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments described below are for illustrative purposes only, and those skilled in the art will readily appreciate other obvious variations. The basic principles of the present invention defined in the following description may be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0027] Please refer to Figures 1 to 6 The embodiment of the present invention provides a double-leaflet balloon sheath for antegrade in situ aortic fenestration (hereinafter referred to as sheath), comprising: A sheath body 100 , wherein a working channel 110 is provided in the sheath body 100 ; The proximal balloon 200 includes a plurality of proximal lobed balloons 210 . The plurality of proximal lobed balloons 210 are spaced apart around the sheath body 100 , and a proximal blood flow channel 220 is provided between adjacent proximal lobed balloons 210 . The distal balloon 300 includes a plurality of distal lobed balloons 310 , which are spaced apart around the sheath body 100 . Distal blood flow channels 320 are provided between adjacent distal lobed balloons 310 . The distal balloon 300 is disposed distally of the sheath body 100 relative to the proximal balloon 200 . An operating handle 400 is connected to the proximal end of the sheath body 100 and is provided with: A main channel interface 410 , the main channel interface 410 being in communication with the working channel 110 ; a proximal filling port 420 , the proximal filling port 420 being in communication with the proximal balloon 200 ; The distal filling port 430 is connected to the distal balloon 300 .

[0028] Both the proximal balloon 200 and the distal balloon 300 adopt a lobed design, which can better adapt to the anatomical structure of the aorta. When faced with aortic torsion, angulation, and other conditions, the multiple lobed balloons can independently conform to the vessel wall, providing stable support for the sheath body 100 through a multi-point abutment method. This makes it easier for the sheath body 100 to maintain coaxiality and perpendicularity with the target vessel opening, effectively reducing the problems of tip offset and puncture direction deviation during antegrade fenestration, greatly improving puncture stability, reducing the risk of surgical failure, and avoiding the situation where multiple puncture attempts prolong the operation time and increase the pain and risk for the patient.

[0029] Unlike the prior art, where the positioning balloon needs to be inflated to a larger diameter to obtain sufficient support, thereby completely or partially blocking aortic blood flow, the proximal balloon 200 and distal balloon 300 of the present invention adopt a lobed design, with blood flow channels provided between adjacent lobed balloons. While the balloon is inflated to provide support, some blood is allowed to flow through the blood flow channels, without completely blocking aortic blood flow. When treating lesions involving branches of important organs such as the renal artery, it can ensure blood supply to distal limbs and internal organs, avoiding irreversible damage caused by prolonged ischemia, providing more time for surgical operations, and reducing surgical difficulty and pressure.

[0030] like Figure 1 and Figure 2 As shown, the sheath body 100 is a hollow structure, and the working channel 110, the proximal filling cavity and the distal filling cavity are formed therein.

[0031] The working channel 110 is used to provide the necessary instrument access for surgical procedures by passing interventional tools such as guidewires and puncture needle systems. The proximal filling cavity communicates with the proximal filling port 420 and the proximal balloon 200 and is used to fill or aspirate liquid into the proximal balloon 200 to control the filling state of the proximal balloon 200. The distal filling cavity communicates with the distal filling port 430 and the distal balloon 300 and is used to fill or aspirate liquid into the distal balloon 300 to control the filling state of the distal balloon 300.

[0032] The sheath body 100 is made of the medical polymer material PEBAX (polyether block amide). PEBAX combines the rigidity of polyamide with the flexibility of polyether. This property gives the sheath body 100 excellent flexibility and pushability, enabling it to smoothly navigate tortuous vascular pathways and reach aortic lesions. Precision extrusion equipment can be used to extrude the sheath body 100, including the working channel 110, proximal filling lumen, and distal filling lumen, in a single operation.

[0033] like Figure 1 、 Figure 2 and Figure 7 As shown, a puncture side hole 120 is opened on the outer wall of the sheath body 100, and the puncture side hole 120 connects the working channel 110 with the outside. The puncture side hole 120 is located between the proximal balloon 200 and the distal balloon 300.

[0034] This design sets the puncture side hole 120 in the stable balloon area of ​​the sheath side wall, so that the operator only needs to place the sheath body 100 parallel to the aortic wall, and the puncture side hole 120 can naturally face the target blood vessel wall. When the puncture needle drills out of the puncture side hole 120, it can puncture at an ideal angle close to 90°, which simplifies the operation, reduces the requirement for the operator to bend the sheath angle, and improves the success rate and safety of antegrade puncture.

[0035] High-precision laser cutting can be used to cut a smooth, burr-free, oval puncture side hole 120 on the outer side of the sheath tube body 100 between the proximal balloon 200 and the distal balloon 300 .

[0036] like Figures 1 to 4 As shown, the proximal balloon 200 includes a plurality of proximal lobed balloons 210 , and the plurality of proximal lobed balloons 210 are spaced apart around the sheath body 100 .

[0037] Materials such as nylon or PET (polyethylene terephthalate) can be selected and placed in a pre-designed metal mold to form the proximal lobed balloon 210 through a blow molding process.

[0038] The proximal lobed balloon 210 can be fixed to the outer wall of the sheath body 100 by hot melting or gluing.

[0039] The proximal lobed balloon 210 is cylindrical after being inflated. When used in a blood vessel, the sidewall of the cylindrical proximal lobed balloon 210 can better fit the blood vessel wall, provide uniform support, and effectively prevent the blood vessel from collapsing or deforming.

[0040] The number of the proximal lobed balloons 210 may be five, but is not limited thereto.

[0041] Proximal blood flow channels 220 are located between adjacent proximal lobulated balloons 210. When the proximal balloons 200 are inflated, the multiple proximal lobulated balloons 210 expand outward, firmly resting against the inner wall of the aorta like claws at multiple points. This creates an extremely stable multi-point support platform, effectively resisting blood flow impact and the reaction force during puncture. While ensuring device stability, the proximal blood flow channels 220 between the proximal lobulated balloons 210 ensure that at least 50% of the aortic cross-sectional area remains open, maintaining continuous perfusion of the distal aorta and its side branches, and avoiding the risk of organ and limb ischemia caused by blood flow obstruction.

[0042] refer to Figure 2 , the proximal balloon 200 further includes: The proximal tube 230, the two ends of the proximal lobed balloon 210 are respectively connected to the sheath body 100 through the proximal tube 230, and the proximal tube 230 is connected to the proximal filling cavity, and the proximal lobed balloon 210 is filled or sucked of liquid through the proximal filling cavity to realize the control of the filling state of the proximal lobed balloon 210.

[0043] The proximal tube 230 can serve as a filling port for the proximal lobed balloon 210. A small hole is provided on the side wall of the sheath body 100. After the proximal lobed balloon 210 is bonded to the side wall of the sheath body 100, the proximal tube 230 is connected to the small hole, thereby achieving communication between the proximal lobed balloon 210 and the proximal filling cavity.

[0044] like Figure 5 and Figure 6 As shown, the distal balloon 300 includes multiple distal lobed balloons 310, and the multiple distal lobed balloons 310 are arranged at intervals around the sheath body 100. A distal blood flow channel 320 is provided between adjacent distal lobed balloons 310. The distal balloon 300 is arranged at the distal end of the sheath body 100 relative to the proximal balloon 200.

[0045] The design principle of the distal lobed balloon 310 is similar to that of the proximal lobed balloon 210 , which provides stable support when filled while ensuring blood circulation through the distal blood flow channel 320 , which will not be elaborated here.

[0046] refer to Figure 2 , the distal balloon 300 further includes: The distal tube 330 connects the two ends of the distal lobed balloon 310 to the sheath body 100 respectively through the distal tube 330. The distal tube 330 is in communication with the distal filling cavity to control the filling state of the distal lobed balloon 310.

[0047] The distal lobed balloon 310 first performs preliminary positioning and initial stabilization, securing the sheath body 100 in the target area. After the distal lobed balloon 310 provides overall stabilization, the proximal balloon 200 is micro-inflated to further adjust the angle and distance between the puncture side hole 120 and the target vessel wall, achieving fine-tuning and secondary stabilization. Subsequently, the proximal lobed balloon 210 is fully inflated, providing dual-balloon combined, stable support for the entire sheath. This combined design significantly improves positioning accuracy and adaptability to diverse anatomical conditions.

[0048] refer to Figures 1 to 6 The plurality of proximal lobed balloons 210 are arranged circumferentially about the centerline of the sheath body 100. When used within a blood vessel, the circumferentially arranged proximal lobed balloons 210 can be evenly distributed around the sheath body 100. When the balloons are inflated, they can apply uniform pressure to the vessel wall from all directions, providing all-round support and effectively preventing damage or deformation caused by uneven local force on the vessel. For example, when dilating a stenotic vessel, this uniform support can evenly distribute the dilation force on the vessel wall, which is more conducive to restoring the normal morphology and patency of the vessel.

[0049] The distal balloon 300 has a distal centerline, and the plurality of distal lobed balloons 310 are arranged in a circle about the distal centerline, with the distal centerline offset from the centerline of the sheath body 100. The offset distal centerline enables the distal lobed balloons 310 to exert asymmetric forces on specific portions of a blood vessel when inflated, thereby achieving more precise manipulation. For example, when treating lesions at a vascular bifurcation, this arrangement allows the distal lobed balloons 310 to better conform to the shape of the vascular bifurcation, providing targeted dilation or support for the lesion at the bifurcation, thereby improving the therapeutic effect.

[0050] like Figure 7As shown, both the proximal balloon 200 and the distal balloon 300 are provided with developing rings 500. These developing rings 500 are used to clearly visualize the surgical sheath and balloon under radiographic conditions during surgery, thereby accurately indicating the specific positions of the sheath and balloon to the surgeon. Specifically, each proximal lobed balloon 210 and each distal lobed balloon 310 is independently provided with a developing ring 500.

[0051] The development ring is an X-ray development marking ring used in the distal working area of ​​medical devices during interventional therapy.

[0052] like Figure 1 and Figure 2 As shown, the distal end of the sheath body 100 is used to be placed in the body cavity, and the proximal end of the sheath body 100 is located outside the body. The proximal end of the sheath body 100 is connected to the operating handle 400, and the dilator 600, the in-situ window assembly, the catheter or the guide wire are inserted into the working channel 110 through the main channel interface 410 on the operating handle 400. The proximal balloon 200 is filled or aspirated with liquid through the proximal filling port 420 to achieve the inflation and deflation operation of the proximal balloon 200. The distal balloon 300 is filled or aspirated with liquid through the distal filling port 430 to achieve the inflation and deflation operation of the distal balloon 300.

[0053] like Figure 1 and Figure 2 As shown, the operating handle 400 is further provided with a three-way pipe 440, and the three-way pipe 440 has a valve adjustment function. By operating the valve, the connection between the three-way pipe 440 and the working channel 110 can be flexibly adjusted, and the working channel 110 can be flushed using the three-way pipe 440.

[0054] The operating handle 400 can be injection molded from a material such as polycarbonate. The operating handle 400 is firmly connected to the proximal end of the sheath body 100 by bonding, snapping, or the like.

[0055] like Figure 8 and Figure 9 As shown, the sheath tube also includes: The expander 600 is inserted into the working channel 110. The center of the expander 600 is provided with a guidewire lumen for a guidewire to pass through.

[0056] During actual operation, the dilator 600 is first inserted into the working channel 110 from the main channel interface 410 of the sheath body 100, ensuring that the tip of the dilator 600 passes through the distal end of the sheath body 100. Next, the guidewire is inserted into the guidewire lumen of the dilator 600, and the sheath body 100 with the dilator 600 is pushed along the guidewire path and slowly inserted into the blood vessel.

[0057] During the insertion process, the expander 600 will expand the sheath body 100 and generate a uniform outward expansion force on the blood vessel wall, gradually increasing the inner diameter of the blood vessel, ensuring that the sheath body 100 can be accurately introduced into the surgical site through the blood vessel.

[0058] After the sheath tube body 100 reaches the surgical site, the dilator 600 is slowly pushed out from the sheath tube body 100 along the guide wire so as to perform other surgical operations later.

[0059] The method of using the sheath is as follows: 1. Preoperative Preparation Before surgery, the patient needs to undergo aortic CTA (computed tomography angiography) examination, the purpose of which is to accurately determine the extent of the lesion and the specific anatomical location of the branch arteries.

[0060] II. Approach and Stent Deployment Using the Seldinger technique (a minimally invasive medical procedure for percutaneous puncture of blood vessels or hollow organs), the femoral artery or axillary / brachial artery is selected as the access site to establish a surgical channel.

[0061] Following standard operating procedures, the main stent graft is precisely deployed at the aortic lesion. The deployment location of this stent is precisely planned based on the extent of the lesion as determined by preoperative CTA examination, ensuring that the stent completely covers the lesion area and one or more target visceral branch arteries that require reconstruction.

[0062] 3. Introduction of the apparatus of the present invention Using a guidewire (such as a 0.035-inch Lunderquist guidewire), the sheath is advanced into the patient's body and along the aorta until it reaches the inside of the deployed stent graft.

[0063] The Lunderquist guidewire is an extra-hard guidewire designed for vascular interventional diagnostic and therapeutic procedures.

[0064] 4. Positioning and Stability Under real-time fluoroscopic monitoring (DSA, digital subtraction angiography), the distal end of the sheath is moved to the estimated position of the target branch artery opening.

[0065] Diluted contrast agent is slowly injected into the distal balloon 300 through the distal filling port 430 of the operating handle 400. As the contrast agent is injected, the distal lobed balloon 310 gradually expands and rests tightly against the inner wall of the stent graft. At this point, the aortic blood flow can be clearly seen flowing smoothly through the distal blood flow channel 320 in the image, and the sheath has also achieved initial stability, providing a stable platform for subsequent operations.

[0066] If the angle and contact of the distal end of the sheath are still not ideal after initial stabilization, a small amount of liquid can be injected into the proximal balloon 200 through the proximal filling port 420. By precisely controlling the amount of liquid injected, the angle and contact of the distal end of the sheath can be fine-tuned to ensure that the sheath is in the optimal operating position.

[0067] 5. Puncture fenestration After confirming that the sheath is stable and positioned correctly, the operator withdraws the dilator 600 to make room for the subsequent introduction of the fenestration assembly.

[0068] The window assembly is introduced into the sheath, and the puncture needle is pushed out from the puncture side hole 120 by operating the puncture needle control mechanism of the operating handle 400, so that the puncture needle accurately penetrates the coating material of the coated stent at a vertical angle.

[0069] When the operator feels a breakthrough, the needle is discontinued.

[0070] 6. Establish branch channels A 0.014 or 0.018 inch guide wire is delivered through the main channel interface 410 via the puncture needle system, passed through the newly created fenestration, and successfully entered the target branch artery.

[0071] After confirming that the guidewire is accurately in place, withdraw the puncture needle first, leaving the guidewire and sheath in place to provide guidance for subsequent operations.

[0072] 7. Equipment Removal and Completion of Reconstruction The proximal balloon 200 and the distal balloon 300 are completely deflated.

[0073] The sheath was withdrawn along the guidewire remaining in the branch artery.

[0074] Through the retained guidewire, a balloon catheter is inserted to pre-dilate the fenestration. Subsequently, a suitable bridging stent is introduced and deployed, ensuring that one end of the stent is precisely anchored within the main aortic stent and the other end smoothly extends into the branch artery, thereby permanently reestablishing blood flow in the branch artery and restoring its normal blood supply function.

[0075] 8. Repetition and Completion If the patient has multiple branches requiring fenestration, the above steps can be repeated. Once all branches are fenestrated and stent deployment is complete, the surgery is concluded after confirming through angiography that the main stent is in good shape, has no endoleaks, and that all branch stents are unobstructed and all indicators meet the criteria for surgical success.

[0076] The embodiments described above are only used to illustrate the technical ideas and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. The scope of the patent application of the present invention cannot be limited by these embodiments alone. That is, any equivalent changes or modifications made according to the spirit disclosed by the present invention still fall within the patent scope of the present invention.

Claims

1. A double-leaf balloon sheath for antegrade in situ aortic fenestration, characterized in that: include: A sheath tube body (100), wherein a working channel (110) is provided in the sheath tube body (100); A proximal balloon (200), the proximal balloon (200) comprising a plurality of proximal lobed balloons (210), the plurality of proximal lobed balloons (210) being spaced apart around the sheath tube body (100), and a proximal blood flow channel (220) being provided between adjacent proximal lobed balloons (210); A distal balloon (300), the distal balloon (300) comprising a plurality of distal lobed balloons (310), the plurality of distal lobed balloons (310) being arranged at intervals around the sheath tube body (100), a distal blood flow channel (320) being provided between adjacent distal lobed balloons (310), the distal balloon (300) being arranged adjacent to the distal end of the sheath tube body (100) relative to the proximal balloon (200); An operating handle (400) is connected to the proximal end of the sheath tube body (100), and the operating handle (400) is provided with: a main channel interface (410), the main channel interface (410) being in communication with the working channel (110); A proximal filling port (420), the proximal filling port (420) being in communication with the proximal balloon (200); A distal filling port (430), wherein the distal filling port (430) is in communication with the distal balloon (300).

2. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The plurality of proximal lobed balloons (210) are arranged in a circle around the center line of the sheath body (100).

3. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1 or 2, characterized in that: The distal balloon (300) has a distal centerline, and the plurality of distal lobed balloons (310) are arranged in a circle around the distal centerline, and the distal centerline is offset from the centerline of the sheath body (100).

4. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The sheath tube body (100) is provided with: a proximal filling cavity, the proximal filling cavity communicating with the proximal filling port (420) and the proximal balloon (200); A distal filling cavity is provided, wherein the distal filling cavity is connected to the distal filling port (430) and the distal balloon (300).

5. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The proximal balloon (200) further comprises: A proximal tube (230), wherein both ends of the proximal lobed balloon (210) are connected to the sheath tube body (100) through the proximal tube (230).

6. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The distal balloon (300) further comprises: A distal tube (330), wherein both ends of the distal lobed balloon (310) are connected to the sheath tube body (100) through the distal tube (330).

7. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: A puncture side hole (120) is provided on the outer wall of the sheath tube body (100), and the puncture side hole (120) is connected to the working channel (110) and the outside; The puncture side hole (120) is located between the proximal balloon (200) and the distal balloon (300).

8. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The proximal balloon (200) and the distal balloon (300) are provided with developing rings (500).

9. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: The operating handle (400) is further provided with a three-way pipe (440), and the three-way pipe (440) is in communication with the working channel (110).

10. The double-leaflet balloon sheath for antegrade in situ aortic fenestration according to claim 1, characterized in that: Also includes: The expander (600) is inserted into the working channel (110).

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