A dual multi-lobed balloon sheath for aortic antegrade in-situ fenestration

Abstract

The application provides a double multi-leaf balloon sheath for aortic antegrade in-situ fenestration, which comprises a sheath body, a proximal balloon, a distal balloon and an operating handle, and a working channel is arranged in the sheath body; the proximal balloon comprises a plurality of proximal split balloons, the plurality of proximal split balloons are arranged at intervals around the sheath body, and a proximal blood flow channel is arranged between adjacent proximal split balloons; the distal balloon comprises a plurality of distal split balloons, the plurality of distal split balloons are arranged at intervals around the sheath body, a distal blood flow channel is arranged between adjacent distal split balloons, and the distal balloon is arranged close to a distal end of the sheath body relative to the proximal balloon; and the puncture fenestration operation is stably, accurately and efficiently completed under the premise that the aortic blood flow is not completely blocked.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of sheath technology, and particularly relates to a double multi-leaf balloon sheath for antegrade in-situ fenestration of aorta. BACKGROUND

[0002] In the treatment of aortic diseases involving visceral branch vessels (such as abdominal aortic aneurysm and aortic dissection), when the lesions involve important branch arteries such as renal arteries and superior mesenteric arteries, preserving the blood flow of these arteries is crucial for maintaining the function of the patient's organs and postoperative recovery. In-situ fenestration technology, as a key means to solve such problems, can puncture a hole on the site of the standard covered stent that has been placed to reconstruct the blood flow of the branch artery, and is particularly suitable for emergency situations such as emergency.

[0003] In the development process of in-situ fenestration technology, the emergence of special needle fenestration instruments is an important step. Instruments such as Futhrough (aortic covered stent membrane breaking system) and Quick Fenestrater (a transluminal controllable membrane breaking system) are specially designed for in-situ fenestration. Such instruments are usually composed of a catheter sheath and a puncture needle core. For example, Futhrough is provided with a coaxial, non-compliant positioning balloon near the tip of the puncture needle. When used, the instrument is sent to the target position and the balloon is inflated to make it adhere to the opposite aortic wall, providing counteracting support for the puncture needle, thereby achieving relatively stable puncture operation.

[0004] However, the existing special needle fenestration instruments still have many significant defects in actual application:

[0005] 1. Poor stability: Although the coaxial balloon provides support, it is difficult for the instrument and the target vessel opening to maintain coaxiality and perpendicularity in the face of complex anatomical structures such as aortic twisting and angulation. The head end is easily deviated during antegrade fenestration, the puncture direction is deviated, the risk of failure is increased, multiple attempts are required, the operation time is prolonged, and the patient's pain and risk are increased.

[0006] 2. Large blood flow obstruction: The positioning balloon needs to be inflated to a larger diameter to obtain sufficient support, which will completely or mostly block the aortic blood flow. When dealing with lesions involving important organ branch vessels such as the renal artery, the distal extremities and internal organs will be ischemic, and prolonged ischemia will cause irreversible damage, seriously affecting postoperative recovery, compressing the operation time window, and increasing the difficulty and pressure of the operation.

[0007] 3. Difficulty in positioning antegrade fenestration: When performing antegrade fenestration from the aortic lumen outward, the covered branch artery opening cannot be directly observed, making positioning difficult. In the face of complex conditions such as aortic twisting and calcification, it is difficult to adjust the puncture needle to the ideal vertical angle, resulting in high puncture failure rate or long time consumption, low efficiency and increased risk of operation. SUMMARY

[0008] The purpose of the present application is to overcome the deficiencies in the prior art, provide a double multi-leaf balloon sheath for aortic antegrade in-situ fenestration, which can complete the puncture fenestration operation stably, accurately and efficiently under the premise of not completely blocking the aortic blood flow, thereby improving the success rate of operation and reducing the risk of intraoperative ischemic complications, and providing a safer and more effective treatment method for patients.

[0009] In order to achieve the above-mentioned purpose, the present application provides the following technical scheme:

[0010] A double multi-leaf balloon sheath for aortic antegrade in-situ fenestration comprises:

[0011] A sheath body is provided with a working channel inside the sheath body;

[0012] A proximal balloon comprises a plurality of proximal split balloons, and the plurality of proximal split balloons are arranged at intervals around the sheath body, and a proximal blood flow channel is arranged between adjacent proximal split balloons;

[0013] A distal balloon comprises a plurality of distal split balloons, and the plurality of distal split balloons are arranged at intervals around the sheath body, and a distal blood flow channel is arranged between adjacent distal split balloons, and the distal balloon is arranged adjacent to a distal end of the sheath body relative to the proximal balloon;

[0014] An operation handle is connected to a proximal end of the sheath body, and the operation handle is provided with:

[0015] A main channel interface in communication with the working channel;

[0016] A proximal inflation port in communication with the proximal balloon;

[0017] A distal inflation port in communication with the distal balloon.

[0018] As a preferred embodiment, the plurality of proximal split balloons are arranged in a circle around the center line of the sheath body.

[0019] As a preferred embodiment, the distal balloon has a distal center line, and the plurality of distal split balloons are arranged in a circle around the distal center line, and the distal center line is arranged offset from the center line of the sheath body.

[0020] As a preferred embodiment, the sheath body is provided with:

[0021] A proximal inflation cavity in communication with the proximal inflation port and the proximal balloon;

[0022] A distal filling cavity, which is communicated with the distal filling port and the distal balloon.

[0023] As a preferred embodiment, the proximal balloon further comprises:

[0024] A proximal tube, through which two ends of the proximal split balloon are connected to the sheath tube body.

[0025] As a preferred embodiment, the distal balloon further comprises:

[0026] A distal tube, through which two ends of the distal split balloon are connected to the sheath tube body.

[0027] As a preferred embodiment, a puncture side hole is arranged on the outer wall of the sheath tube body, which is communicated with the working channel and the outside.

[0028] As a preferred embodiment, the puncture side hole is located between the proximal balloon and the distal balloon.

[0029] As a preferred embodiment, a developing ring is arranged on the proximal balloon and the distal balloon.

[0030] As a preferred embodiment, a three-way tube is further arranged on the operation handle, which is communicated with the working channel.

[0031] As a preferred embodiment, it further comprises:

[0032] A dilator, which is inserted into the working channel.

[0033] Compared with the prior art, the technical scheme has the following advantages:

[0034] Both the proximal balloon and the distal balloon are designed to be in multi-point contact with the blood vessel wall through a plurality of split balloon balloons, which provides stable support for the sheath tube body, effectively prevents slipping or displacement during puncture, and reduces the risk of blood vessel injury.

[0035] The blood flow channel design between the split balloons retains the main aortic blood flow, avoids organ and limb ischemia, and reduces complications caused by ischemia.

[0036] Firstly, the distal end of the sheath tube is positioned by the distal balloon, and then the fine adjustment and secondary stabilization are realized by the filling control of the proximal balloon, which provides double-balloon joint and stable support for the overall sheath tube. This combined design greatly improves the positioning accuracy and adaptability to different anatomical conditions.

[0037] The side wall of the sheath body is provided with a puncture side hole, which is located between the proximal balloon and the distal balloon and can naturally face the target blood vessel wall, and the puncture needle can be punctured at an ideal angle of nearly 90° when it is drilled out of the puncture side hole, which simplifies the operation, reduces the requirement for the operator to move the angle of the sheath, and improves the success rate and safety of antegrade puncture.

[0038] Due to the effective solution of the instrument stability and positioning problem, the puncture process becomes more direct and controllable, the number of repeated attempts and adjustments is reduced, and the operation time is shortened, the amount of contrast agent is reduced, and the X-ray radiation exposure is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1 The figure is a schematic diagram of the double multi-leaf balloon sheath for antegrade in-situ fenestration of the aorta according to the present application in an un-inflated state;

[0040] Figure 2 The figure is a schematic diagram of the double multi-leaf balloon sheath for antegrade in-situ fenestration of the aorta according to the present application in an inflated state;

[0041] Figure 3 The figure is a schematic diagram of the proximal balloon according to the present application in an un-inflated state;

[0042] Figure 4 The figure is a schematic diagram of the proximal balloon according to the present application in an inflated state;

[0043] Figure 5 The figure is a schematic diagram of the distal balloon according to the present application in an un-inflated state;

[0044] Figure 6 The figure is a schematic diagram of the distal balloon according to the present application in an inflated state;

[0045] Figure 7 The figure is a schematic diagram of the puncture side hole structure on the sheath body according to the present application;

[0046] Figure 8 The figure is a schematic diagram of the joint of the dilator according to the present application;

[0047] Figure 9 The figure is a schematic diagram of the assembly of the dilator and the sheath body according to the present application.

[0048] In the figure: 100 sheath body, 110 working channel, 120 puncture side hole, 200 proximal balloon, 210 proximal multi-leaf balloon, 220 proximal blood flow channel, 230 proximal tube, 300 distal balloon, 310 distal multi-leaf balloon, 320 distal blood flow channel, 330 distal tube, 400 operation handle, 410 main channel interface, 420 proximal filling port, 430 distal filling port, 440 three-way tube, 500 developing ring, 600 dilator. DETAILED DESCRIPTION

[0049] The following description is presented to enable any person skilled in the art to practice the application as claimed. Preferred embodiments are presented in the following description only as examples and modifications thereto can be made by those skilled in the art without departing from the spirit and scope of the application claimed. The present application is defined by the following claims with equivalents of the scope of the claims to be included.

[0050] Reference should be made to Figures 1 to 6 The embodiments of the present application provide a double multi-lobed balloon sheath for aortic antegrade in-situ fenestration, comprising:

[0051] A sheath body 100, wherein a working channel 110 is arranged in the sheath body 100;

[0052] A proximal balloon 200, wherein a plurality of proximal lobe balloons 210 are arranged around the sheath body 100, and a proximal blood flow channel 220 is arranged between adjacent proximal lobe balloons 210;

[0053] A distal balloon 300, wherein a plurality of distal lobe balloons 310 are arranged around the sheath body 100, and a distal blood flow channel 320 is arranged between adjacent distal lobe balloons 310, and the distal balloon 300 is arranged adjacent to a distal end of the sheath body 100 relative to the proximal balloon 200;

[0054] An operation handle 400, wherein the operation handle 400 is connected to a proximal end of the sheath body 100, and the operation handle 400 is provided with:

[0055] A main channel interface 410, wherein the main channel interface 410 is in communication with the working channel 110;

[0056] A proximal inflation port 420, wherein the proximal inflation port 420 is in communication with the proximal balloon 200;

[0057] A distal inflation port 430, wherein the distal inflation port 430 is in communication with the distal balloon 300.

[0058] The proximal balloon 200 and the distal balloon 300 both adopt a split-leaf design, which can better adapt to the anatomical structure of the aorta. When facing the aortic twist, angle and other situations, multiple split-leaf balloons can independently adhere to the blood vessel wall, and adopt a multi-point adhering mode to provide stable support for the sheath body 100, so that the sheath body 100 and the target blood vessel opening are more easily coaxial and perpendicular, effectively reducing the problems of head end deviation and puncture direction deviation during antegrade fenestration, greatly improving the stability of puncture, reducing the risk of surgical failure, and avoiding the situation of prolonging the operation time, aggravating the patient's pain and risk due to multiple attempts to puncture.

[0059] Unlike the positioning balloon in the prior art which needs to be inflated to a larger diameter to obtain sufficient support force to completely or mostly block the aortic blood flow, the proximal balloon 200 and the distal balloon 300 of the present application adopt a split-leaf design, and blood flow channels are provided between adjacent split-leaf balloons. While the balloon provides support, part of the blood is allowed to flow through the blood flow channel, without completely blocking the aortic blood flow. When dealing with lesions involving important organ branch lesions such as renal arteries, the blood supply to the distal extremities and internal organs can be ensured, avoiding irreversible damage caused by long-term ischemia, providing more time for surgical operation, and reducing the difficulty and pressure of the operation.

[0060] As shown in Figure 1 and Figure 2 , the sheath body 100 is a hollow structure, and the working channel 110, the proximal inflation cavity and the distal inflation cavity are formed inside.

[0061] The working channel 110 is used to pass through the guide wire, puncture needle system and other interventional tools to provide necessary instrument access for surgical operation. The proximal inflation cavity is connected with the proximal inflation port 420 and the proximal balloon 200, and is used to inflate or suck liquid to the proximal balloon 200, so as to control the inflation state of the proximal balloon 200. The distal inflation cavity is connected with the distal inflation port 430 and the distal balloon 300, and is used to inflate or suck liquid to the distal balloon 300, so as to control the inflation state of the distal balloon 300.

[0062] The sheath body 100 is made of medical polymer material PEBAX (polyether block amide). PEBAX material has the rigidity of polyamide and the flexibility of polyether, which makes the sheath body 100 have good flexibility and pushability, and can smoothly pass through the tortuous blood vessel path to reach the aortic lesion. The sheath body 100 with the working channel 110, the proximal inflation cavity and the distal inflation cavity can be extruded at one time by using a precision extrusion device.

[0063] As shown in Figure 1 , Figure 2 and Figure 7As shown, a puncture side hole 120 is provided on the outer wall of the sheath body 100, and the puncture side hole 120 connects the working channel 110 and the outside. The puncture side hole 120 is located between the proximal balloon 200 and the distal balloon 300.

[0064] This design places the puncture side hole 120 in the stable balloon area of ​​the sheath side wall, allowing the operator to simply place the sheath body 100 parallel to the aortic wall, and the puncture side hole 120 will naturally face the target vessel wall. When the puncture needle drills out of the puncture side hole 120, it can puncture at an ideal angle of close to 90°, simplifying the operation, reducing the requirements for the operator to bend the sheath angle, and improving the success rate and safety of antegrade puncture.

[0065] A smooth, burr-free elliptical puncture side hole 120 can be cut on the outer side of the sheath body 100 between the proximal balloon 200 and the distal balloon 300 using high-precision laser cutting.

[0066] like Figures 1 to 4 As shown, the proximal balloon 200 includes a plurality of proximal lobulated balloons 210, which are spaced apart around the sheath body 100.

[0067] Materials such as nylon or PET (polyethylene terephthalate) can be used. The proximal lobulated balloon 210 is formed by placing it in a pre-designed metal mold and using a blow molding process.

[0068] The proximal lobulated balloon 210 can be fixed to the outer wall of the sheath body 100 by hot melting or adhesive bonding.

[0069] The inflated proximal lobulated balloon 210 is cylindrical. When used intravascularly, the sidewalls of the cylindrical proximal lobulated balloon 210 can better conform to the vessel wall, providing uniform support and effectively preventing vessel collapse or deformation.

[0070] The number of the proximal lobulated balloons 210 may be five, but is not limited to this.

[0071] A proximal blood flow channel 220 is provided between adjacent proximal lobulated balloons 210. When the proximal balloon 200 is inflated, multiple proximal lobulated balloons 210 will expand outwards, firmly abutting against multiple points on the inner wall of the aorta like claws, forming an extremely stable multi-point support platform that effectively resists blood flow impact and reaction force during puncture. While achieving device stability, the design of the proximal blood flow channel 220 between the proximal lobulated balloons 210 ensures that at least 50% of the aortic cross-sectional area is open, maintaining continuous perfusion of the distal aorta and collateral branches, and avoiding the risk of organ and limb ischemia caused by blood flow obstruction.

[0072] Reference Figure 2 , the proximal balloon 200 further comprises:

[0073] The proximal tube 230 connects the sheath tube body 100 at both ends of the proximal split balloon 210, and the proximal tube 230 is in communication with the proximal inflation cavity to control the inflation state of the proximal split balloon 210 by inflating or pumping liquid into the proximal split balloon 210 through the proximal inflation cavity.

[0074] The proximal tube 230 can serve as an inflation port of the proximal split balloon 210. A small hole is provided on the side wall of the sheath tube body 100, and the proximal split balloon 210 is bonded to the side wall of the sheath tube body 100. The proximal tube 230 is connected to the small hole to realize the communication between the proximal split balloon 210 and the proximal inflation cavity.

[0075] As shown in Figure 5 and Figure 6 , the distal balloon 300 comprises a plurality of distal split balloons 310, and the plurality of distal split balloons 310 are arranged at intervals around the sheath tube body 100. The distal blood flow channel 320 is provided between adjacent distal split balloons 310, and the distal balloon 300 is arranged close to the distal end of the sheath tube body 100 relative to the proximal balloon 200.

[0076] The design principle of the distal split balloon 310 is similar to that of the proximal split balloon 210. When inflated, it provides stable support while ensuring blood flow through the distal blood flow channel 320. Herein, no further description is made.

[0077] Reference Figure 2 , the distal balloon 300 further comprises:

[0078] The distal tube 330 connects the sheath tube body 100 at both ends of the distal split balloon 310. The distal tube 330 is in communication with the distal inflation cavity to control the inflation state of the distal split balloon 310.

[0079] The distal split balloon 310 first performs preliminary positioning and preliminary stabilization to fix the sheath tube body 100 in the target area. After the distal split balloon 310 provides overall stabilization, the proximal balloon 200 is slightly inflated to further adjust the angle and distance of the puncture side hole 120 to the target blood vessel wall, achieving fine adjustment and secondary stabilization. Subsequently, the proximal split balloon 210 is fully inflated to provide overall sheath tube double-balloon combined and stable support. This combined design greatly improves the accuracy of positioning and adaptability to different anatomical conditions.

[0080] Reference Figures 1 to 6, multiple said proximal partial balloon 210 are arranged in a circle along the center line of the sheath body 100. In intravascular application, the circumferentially arranged proximal partial balloon 210 can be evenly distributed around the sheath body 100, and when the balloon is inflated, it can exert uniform pressure on the blood vessel wall from all directions, providing omnidirectional support and effectively preventing damage or deformation caused by uneven stress on the blood vessel. For example, when dilating a stenotic blood vessel, such uniform support can allow the blood vessel wall to be subjected to balanced expansion force, which is more conducive to restoring the normal morphology and patency of the blood vessel.

[0081] The distal balloon 300 has a distal center line, and multiple distal partial balloons 310 are arranged in a circle along the distal center line, which is offset from the center line of the sheath body 100. The offset distal center line allows the distal partial balloon 310 to generate asymmetric force on a specific part of the blood vessel when inflated, thereby achieving more precise operation. For example, when treating lesions at the bifurcation of a blood vessel, this arrangement allows the distal partial balloon 310 to better conform to the morphology of the blood vessel bifurcation, allowing targeted expansion or support of the lesions at the bifurcation, thereby improving treatment effectiveness.

[0082] As shown in Figure 7 , the proximal balloon 200 and the distal balloon 300 are each provided with a visualization ring 500. These visualization rings 500 serve to clearly visualize under radiation during the operation, thereby accurately indicating the specific position of the sheath and balloon to the operator. Specifically, each proximal partial balloon 210 and each distal partial balloon 310 is independently provided with a visualization ring 500.

[0083] A visualization ring is an X-ray visualization marker ring used for the distal working area of a medical instrument in interventional therapy.

[0084] As shown in Figure 1 and Figure 2 , the distal end of the sheath body 100 is used to be placed into 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 operation handle 400, and a dilator 600, an in-situ fenestration assembly, a catheter or a guide wire, etc. is inserted into the working channel 110 through the main channel interface 410 on the operation handle 400. The proximal balloon 200 is inflated or aspirated by the proximal inflation port 420, and the inflation and deflation of the proximal balloon 200 is realized. The distal balloon 300 is inflated or aspirated by the distal inflation port 430, and the inflation and deflation of the distal balloon 300 is realized.

[0085] As shown in Figure 1 and Figure 2As shown, the operation handle 400 is also provided with a three-way pipe 440, which has a valve adjusting function. By operating the valve, the communication between the three-way pipe 440 and the working channel 110 can be flexibly adjusted, and then the three-way pipe 440 can be used to flush the working channel 110.

[0086] The operation handle 400 can be injection molded by using polycarbonate or other materials. The operation handle 400 and the proximal end of the sheath body 100 are firmly connected by bonding, buckling or other methods.

[0087] As shown in Figure 8 and Figure 9 The sheath further comprises:

[0088] The dilator 600 is inserted into the working channel 110. The center of the dilator 600 is provided with a guide wire lumen for the guide wire to pass through.

[0089] In actual operation, first, the dilator 600 is 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 protrudes from the distal end of the sheath body 100. Then, the guide wire is inserted into the guide wire lumen of the dilator 600, and the sheath body 100 with the dilator 600 is pushed along the path of the guide wire and slowly inserted into the blood vessel.

[0090] During the insertion process, the dilator 600 will play a role in expanding the sheath body 100, and will produce an outward and uniform expansion force on the blood vessel wall, so that the inner diameter of the blood vessel gradually increases, ensuring that the sheath body 100 can be accurately guided to the surgical site through the blood vessel.

[0091] After the sheath body 100 reaches the surgical site, the dilator 600 is slowly pushed out of the sheath body 100 along the guide wire, so that subsequent other surgical operations can be performed.

[0092] The use method of the sheath is as follows:

[0093] I. Preoperative preparation

[0094] The patient needs to be arranged to undergo aortic CTA (computed tomography angiography) examination before the operation. The purpose of this examination is to accurately determine the lesion range and the specific anatomical position of the branch artery.

[0095] II. Approach and stent deployment

[0096] Using Seldinger (a minimally invasive medical operation method for percutaneous puncture of blood vessels or hollow organs) technology, the femoral artery or axillary / humeral artery is selected as the approach site to establish a surgical channel.

[0097] According to the standard operation process, the main body of the stent is accurately released at the aortic lesion. The release position of the stent needs to be accurately planned according to the lesion range determined by the preoperative CTA examination, to ensure that the stent can completely cover the lesion area, and at the same time cover one or more target visceral branch arteries that need to be reconstructed.

[0098] III. Introducing the device of the present application

[0099] With the guidance of a guide wire (for example, a 0.035-inch Lunderquist guide wire), the sheath tube is sent into the patient's body. It advances along the aorta until it reaches the inside of the deployed stent.

[0100] The Lunderquist guide wire is a special hard guide wire designed for vascular interventional diagnosis and treatment surgery.

[0101] IV. Positioning and stabilization

[0102] Under the real-time monitoring of fluoroscopy (DSA, digital subtraction angiography), the distal end of the sheath tube is moved to the estimated position of the target branch artery opening.

[0103] Through the distal inflation port 430 of the operation handle 400, dilute contrast agent is slowly injected into the distal balloon 300. As the contrast agent is injected, the distal lobed balloon 310 gradually expands and tightly adheres to the inner wall of the stent. At this time, the aortic blood flow can be clearly seen in the image passing smoothly from the distal blood flow channel 320, and the sheath tube also obtains preliminary stability, providing a stable platform for subsequent operations.

[0104] If the angle and adhesion of the distal end of the sheath tube are still not ideal after preliminary stabilization, a small amount of liquid can be injected into the proximal balloon 200 through the proximal inflation port 420. By accurately controlling the amount of liquid injected, the angle and adhesion of the distal end of the sheath tube are finely adjusted to ensure that the sheath tube is in the best operating position.

[0105] V. Puncture windowing

[0106] After confirming that the sheath tube is stable and accurately positioned, the operator withdraws the dilator 600 to create space for the subsequent introduction of the windowing assembly.

[0107] The windowing assembly is introduced into the sheath tube, and by operating the puncture needle control mechanism of the operation handle 400, the puncture needle is pushed out of the puncture side hole 120, so that the puncture needle accurately penetrates the stent covering material at a perpendicular angle.

[0108] When the operator feels a breakthrough, stop advancing the puncture needle.

[0109] VI. Establishing a branch passage

[0110] Through the main channel interface 410, a 0.014 or 0.018 inch guidewire is sent out via the puncture needle system, so that it passes through the newly created window and successfully enters the target branch artery.

[0111] After confirming that the guidewire is in place, the puncture needle is withdrawn, leaving the guidewire and sheath in place to provide guidance for subsequent operations.

[0112] Seven, withdrawal of instruments and completion of reconstruction

[0113] The proximal balloon 200 and the distal balloon 300 are completely deflated.

[0114] Along the guidewire retained in the branch artery, the sheath is withdrawn.

[0115] Through the retained guidewire passage, a balloon catheter is sent in to pre-dilate the window. Subsequently, a suitable bridging stent is sent in and released, ensuring that one end of the stent is accurately anchored in the aortic main body stent and the other end smoothly extends into the branch artery, thereby permanently reconstructing the branch blood flow and restoring the normal blood supply function of the branch artery.

[0116] Eight, repetition and completion

[0117] If the patient has multiple branches that need to be windowed, the above steps can be repeated in order. After all branch windowing and stent release operations are completed, the main body stent is confirmed to be in good shape with no internal leakage, and all branch stents are unobstructed, with all indicators meeting the surgical success criteria, the operation is ended.

[0118] The above-described embodiments are only used to illustrate the technical ideas and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and cannot be limited to the patent application range of the present application only by the above-described embodiments, i.e. any equivalent changes or modifications made according to the disclosed spirit of the present application still fall within the patent scope of the present application.

Claims

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

2. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, Multiple of the proximal lobulated balloons (210) are arranged circumferentially around the centerline of the sheath body (100).

3. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1 or 2, characterized in that, The distal balloon (300) has a distal centerline, and a plurality of distal lobulated balloons (310) are arranged circumferentially around the distal centerline, which is offset from the centerline of the sheath body (100).

4. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The sheath body (100) is provided with: The proximal inflation cavity connects the proximal inflation port (420) and the proximal balloon (200). The distal inflation cavity is connected to the distal inflation port (430) and the distal balloon (300).

5. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The proximal balloon (200) also includes: The two ends of the proximal tube (230) are connected to the sheath body (100) through the proximal tube (230).

6. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The distal balloon (300) also includes: The distal tube (330) connects the two ends of the distal lobulated balloon (310) to the sheath body (100) via the distal tube (330).

7. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The outer wall of the sheath body (100) is provided with a puncture side hole (120), which connects 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-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The proximal balloon (200) and the distal balloon (300) are provided with radiopaque rings (500).

9. The double-leaf balloon sheath for antegrade in situ aortic fenestration as described in claim 1, characterized in that, The operating handle (400) is also provided with a three-way pipe (440), which is connected to the working channel (110).

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

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