Balloon perfusion catheter used in aortic dissection surgery

Abstract

The invention provides a balloon perfusion catheter used in aortic dissection, and relates to the technical field of medical instruments.The balloon perfusion catheter comprises a perfusion catheter body and balloons evenly distributed on the periphery of the perfusion catheter body, a perfusion inlet is formed in the near end of the perfusion catheter body, and a perfusion outlet is formed in the far end of the perfusion catheter body; three balloons are distributed on the periphery of the perfusion catheter body, the near-end balloon is a blocking balloon, the middle balloon is a threaded balloon, and the far-end balloon is an expansion balloon. The balloon perfusion catheter can provide continuous perfusion in an aortic dissection operation, remarkably reduces or avoids long-time circulation stopping, effectively prevents perfusion blood from flowing back to an operation area from the inside and the outside of the trunk support through the synergistic effect of the three balloons, provides a clear operation view field for surgeons, and improves the operation efficiency. And accurate suture and reconstruction are facilitated, and the accuracy and safety of an operation are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a balloon perfusion catheter used during aortic dissection surgery. Background Art

[0002] Type A aortic dissection refers to an acute condition in which the aortic intima tears, blood enters the aortic wall, forming true and false lumens, and involving the ascending aorta. The mortality rate increases by 1-2% per hour, and the mortality rate within 48 hours is as high as 50%. Once diagnosed, thoracotomy should be performed as soon as possible. There is a large amount of blood in the aorta. Therefore, after the aorta is transected, the blood continuously flows out, and a clear surgical field of view cannot be obtained. The current conventional method is to temporarily stop the blood circulation in the descending aorta. However, circulatory arrest may cause various serious complications such as brain injury, spinal cord injury, renal insufficiency, and coagulation dysfunction. This is a worldwide problem faced by aortic dissection surgery.

[0003] Currently, some surgeons have attempted to block the descending aorta using a Foley catheter, a COOK Coda balloon catheter, etc., and perform retrograde perfusion through the femoral artery. However, retrograde perfusion through the femoral artery may cause intimal dissection, false lumen perfusion, thrombus and plaque detachment, resulting in organ ischemia, embolism, etc., and the complication rate is high. The outer wall of the balloon is smooth and is prone to displacement under the impact of the perfused blood flow, making it difficult to stably fix it in the aortic elephant trunk stent, which affects the surgical anastomosis operation. Moreover, blood can flow retrograde from the gap between the elephant trunk stent and the aorta to the anastomosis, and a clear surgical field of view still cannot be obtained, and precise suturing and reconstruction cannot be performed. In addition, an important goal of the surgery is to completely thrombose the false lumen. Therefore, during the operation, an elephant trunk stent is implanted to cover the intimal tear, compress the false lumen, promote false lumen thrombosis, and reduce the remaining false lumen. If the pressure in the false lumen is relatively high, the elephant trunk stent may not be fully opened during the operation, reducing the compression of the false lumen, lowering the false lumen thrombosis rate, and affecting the surgical effect. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a balloon perfusion catheter used during aortic dissection surgery to solve the problems existing in the prior art, including reducing the circulatory arrest time, improving the clarity of the surgical field of view, stably fixing the catheter and the stent, promoting false lumen thrombosis, etc.

[0005] To achieve the above purpose, the present invention provides the following technical solutions:

[0006] For the above purposes, the present invention provides a balloon perfusion catheter for use during aortic dissection surgery, which includes a perfusion catheter body and balloons evenly distributed on the outer periphery of the perfusion catheter body. The proximal end of the perfusion catheter body is provided with a perfusion inlet, and the distal end is a perfusion outlet. Three balloons are distributed on the outer periphery of the perfusion catheter body. Among them, the proximal balloon is a blocking balloon, the middle balloon is a threaded balloon, and the distal balloon is a dilation balloon; each of the three balloons is connected to a water filling tube, and a three-way switch is installed on each water filling tube to independently control the inflation and decompression of each balloon.

[0007] As a further aspect of the present invention, the perfusion catheter body is a hollow pipe structure and is made of a flexible medical polymer material.

[0008] As a further aspect of the present invention, the perfusion inlet at one end of the perfusion catheter body is used to connect with the pipeline of an extracorporeal circulation machine.

[0009] As a further aspect of the present invention, the total length of the perfusion catheter body is 36 cm, and the inner diameter is 8 mm. Scale marks are provided on the perfusion catheter body. The scale marks are set at the proximal end of the perfusion catheter body, and the scale marks are marked on the outer periphery of the perfusion catheter body at the 11 - 30 cm scale, with each centimeter as one grid, for positioning the position of the perfusion catheter body within the elephant trunk stent.

[0010] As a further aspect of the present invention, the length of each balloon evenly distributed on the outer periphery of the perfusion catheter body is 2.5 cm, the interval between balloons is 1 cm, and the distal end is left vacant for 0.5 cm.

[0011] As a further aspect of the present invention, the three balloons are made of a medical polymer material.

[0012] As a further aspect of the present invention, several circles of threads are provided on the surface of the threaded balloon, which are used to stably fix the perfusion catheter, the elephant trunk stent, and the aorta together, and block the reverse flow of blood from the gap between the elephant trunk stent and the aorta.

[0013] As a further aspect of the present invention, the proximal balloon is located on the perfusion catheter body on one side of the scale mark, which is used to completely block the retrograde flow of the perfusion blood in the elephant trunk stent to the operative field. The distal balloon is located on the perfusion catheter body at the end of the perfusion outlet, and the distance between the distal balloon and the perfusion outlet is 0.5 cm, which is used to completely open the elephant trunk stent, increase the compression of the false lumen, and at the same time partially block the retrograde flow of the perfusion blood.

[0014] Compared with the prior art, a balloon perfusion catheter for use during aortic dissection surgery proposed by the present invention has the following beneficial effects:

[0015] The balloon perfusion catheter of the present invention can provide continuous perfusion during aortic dissection surgery, significantly reducing or avoiding long-term circulatory arrest, and greatly reducing the risk of surgery-related complications such as brain injury, spinal cord injury, renal insufficiency, and coagulation disorders. Through the synergistic effect of three balloons, especially the proximal occlusion balloon and the intermediate threaded balloon, the present invention effectively prevents the perfused blood from flowing back into the surgical area from inside and outside the elephant trunk stent, providing a clear surgical field of view for the surgeon, facilitating precise suturing and reconstruction, and improving the accuracy and safety of the surgery. Among them, the innovative design of the intermediate threaded balloon solves the problem of easy displacement of the balloon in the prior art. The threaded structure increases the friction with the elephant trunk stent, enabling the perfusion catheter, the elephant trunk stent, and the aorta to be stably fixed together, avoiding displacement during the surgical operation, thereby improving the stability and controllability of the surgery. The design of the distal dilation balloon helps to fully open the elephant trunk stent, increasing the compression force on the false lumen of the aortic dissection, significantly increasing the thrombus formation rate in the false lumen, facilitating the improvement of the surgical effect and reducing the risk of long-term complications. The three balloons can be individually controlled for inflation and decompression, enabling the doctor to flexibly adjust according to the specific situation during the surgery, increasing the adaptability of the catheter, and meeting the needs of different patients and different surgical stages.

[0016] Compared with the existing femoral artery retrograde perfusion technique, the balloon perfusion catheter of the present invention significantly reduces the risk of complications such as intimal dissection, false lumen perfusion, thrombus, and plaque detachment. It not only improves the safety of the surgery but also improves the prognosis of the patient. By providing a clear surgical field of view, a stable operating environment, and effective compression of the false lumen, it helps to improve the overall surgical effect, enabling the surgeon to suture and reconstruct more precisely, while promoting complete thrombosis of the postoperative false lumen. The balloon perfusion catheter of the present invention has significant advantages in improving the safety, effectiveness, and operational convenience of aortic dissection surgery.

[0017] These aspects or other aspects of the present application will be more clearly understood in the following description of the embodiments. It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or related technologies, the following will briefly introduce the drawings required for the description of the exemplary embodiments or related technologies. The drawings are used to provide a further understanding of the present invention and constitute a part of the specification. They are used together with the embodiments of the present invention to explain the present invention and do not constitute a limitation to the present invention. In the drawings:

[0019] Figure 1 It is a schematic structural diagram of a balloon perfusion catheter used during aortic dissection in an embodiment of the present invention.

[0020] Figure 2 It is a schematic cross-sectional view of the terminal of a balloon perfusion catheter used during aortic dissection surgery according to an embodiment of the present invention.

[0021] Figure 3 It is a schematic structural view of a balloon perfusion catheter used during aortic dissection surgery in the application of aortic dissection surgery according to an embodiment of the present invention.

[0022] Reference numerals:

[0023] 1 - Perfusion catheter body, 2 - Perfusion inlet, 3 - Perfusion outlet, 4 - Occlusion balloon, 5 - Threaded balloon, 6 - Dilatation balloon, 7 - Water filling tube, 8 - Three-way switch, 9 - Scale mark, 10 - Left subclavian artery stump, 11 - Elephant trunk stent, 12 - Aorta. Specific embodiments

[0024] Next, in combination with the accompanying drawings and specific embodiments, the present application will be further described. It should be noted that, on the premise of not conflicting, the following-described embodiments or technical features can be arbitrarily combined to form new embodiments.

[0025] To make the purpose, technical solutions and advantages of the present invention clearer and more understandable, the following will further describe the embodiments of the present invention in detail with reference to specific embodiments and the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0026] It should be noted that all the expressions using "first" and "second" in the embodiments of the present invention are used to distinguish two non-identical entities or non-identical parameters with the same name. It can be seen that "first" and "second" are only for the convenience of expression and should not be construed as a limitation on the embodiments of the present invention. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units inherently includes other steps or units.

[0027] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the scope of protection of the present application.

[0028] The flowcharts shown in the drawings are only illustrative examples and do not necessarily include all the contents and operations / steps, nor do they necessarily need to be executed in the described order. For example, some operations / steps can also be decomposed, combined or partially merged, so the actual execution order may change according to the actual situation.

[0029] The following will, with reference to the accompanying drawings, elaborate on some embodiments of the present application. Without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0030] See Figure 1 to Figure 2 As shown, an embodiment of the present invention provides a balloon perfusion catheter for use during aortic dissection surgery, which includes a perfusion catheter body 1 and balloons evenly distributed on the outer periphery of the perfusion catheter body 1. A perfusion inlet 2 is provided at the proximal end of the perfusion catheter body 1, and a perfusion outlet 3 is at the distal end. Three balloons are distributed on the outer periphery of the perfusion catheter body 1. Among them, the proximal balloon is a blocking balloon 4, the middle balloon is a threaded balloon 5, and the distal balloon is a dilation balloon 6.

[0031] In this embodiment, the perfusion catheter body 1 is a hollow pipe structure made of a flexible medical polymer material. Among them, the perfusion inlet 2 at one end of the perfusion catheter body 1 is used to connect with the pipeline of an extracorporeal circulation machine. The balloon perfusion catheter of the present invention can provide continuous perfusion during aortic dissection surgery, significantly reduce or avoid long-term circulatory arrest, and greatly reduce the risk of surgery-related complications such as brain injury, spinal cord injury, renal insufficiency, and coagulation dysfunction.

[0032] In this embodiment, see Figure 1 to Figure 3 As shown, the total length of the perfusion catheter body 1 is 36 cm, and the inner diameter is 8 mm. A scale mark 9 is provided on the perfusion catheter body 1. The scale mark 9 is set at the proximal end of the perfusion catheter body 1 and is marked on the outer periphery of the perfusion catheter body 1 at the 11 - 30 cm scale, with each centimeter as one grid, for positioning the position of the perfusion catheter body 1 within the elephant trunk stent 11.

[0033] Among them, the length of each balloon evenly distributed on the outer periphery of the perfusion catheter body 1 is 2.5 cm, the interval between the balloons is 1 cm, and the distal end is left vacant for 0.5 cm. The three balloons are made of a medical polymer material, and each of the three balloons is connected to a water filling tube 7. A three-way switch 8 is installed on each water filling tube 7 for independently controlling the inflation and decompression of each balloon.

[0034] In this embodiment, the proximal balloon is located on the perfusion catheter body 1 on one side of the scale mark 9 and is used to completely block the retrograde flow of the perfusion blood in the elephant trunk stent 11 into the operative field. The surface of the threaded balloon 5 is provided with several circles of threads, which are used to stably fix the perfusion catheter, the elephant trunk stent 11, and the aorta 12 together and block the reverse flow of blood from the gap between the elephant trunk stent 11 and the aorta 12. The distal balloon is located on the perfusion catheter body 1 at one end of the perfusion outlet 3, and the distance between the distal balloon and the perfusion outlet 3 is 0.5 cm, which is used to completely open the elephant trunk stent 11, increase the compression on the false lumen, and at the same time partially block the retrograde flow of the perfusion blood.

[0035] Through the synergistic effect of three balloons, especially the proximal blocking balloon 4 and the intermediate threaded balloon 5, the present invention effectively prevents the perfused blood from flowing back into the surgical area from the inside and outside of the elephant trunk stent 11, providing a clear surgical field of view for the surgeon, facilitating precise suturing and reconstruction, and improving the accuracy and safety of the surgery. Among them, the innovative design of the intermediate threaded balloon 5 solves the problem that the balloon is prone to displacement in the prior art. The threaded structure increases the friction with the elephant trunk stent 11, and can stably fix the perfusion catheter, the elephant trunk stent 11 and the aorta 12 together, avoiding displacement during the surgical operation, thereby improving the stability and controllability of the surgery. The design of the distal dilation balloon 6 helps to fully open the elephant trunk stent 11, increases the compression force on the false lumen of the aortic dissection, significantly improves the false lumen thrombosis rate, is conducive to improving the surgical effect and reducing the risk of long-term complications. The three balloons can be individually controlled for inflation and decompression, enabling the doctor to flexibly adjust according to the specific situation during the operation, increasing the adaptability of the catheter, and meeting the needs of different patients and different surgical stages.

[0036] See Figure 1 to Figure 3 As shown, during the aortic dissection surgery, after the aorta 12 is placed into the elephant trunk stent 11, a suitable balloon perfusion catheter is selected according to the model of the elephant trunk stent 11. The elephant trunk stent 11 is inserted from one end of the left subclavian artery stump 10 of the aorta 12, and the balloon perfusion catheter is inserted into the elephant trunk stent 11. The position of the balloon perfusion catheter is selected according to the length of the elephant trunk stent 11. For example, if the length of the elephant trunk stent 11 is 12 cm, the 12 cm scale of the balloon perfusion catheter is aligned with the proximal end of the elephant trunk stent 11, and at this time, the tail end b of the catheter is exactly located at the distal end of the elephant trunk stent 11. Through 3 water filling tubes, normal saline is respectively injected into the 3 balloons with a syringe to make them pressurized and inflated, and then the three-way valve is closed. The proximal perfusion inlet a of the balloon perfusion catheter is connected to the extracorporeal circulation machine pipeline to give perfusion and provide blood for the organs. The 3 balloons are individually controlled. If blood flows back from between the outer wall of the balloon and the elephant trunk stent 11 to the anastomosis, the blocking balloon is appropriately pressurized. If blood flows back from between the elephant trunk stent 11 and the aorta 12 to the anastomosis, the threaded balloon is appropriately pressurized. If there is still blood return, the dilation balloon is appropriately pressurized. After the anastomosis of the elephant trunk stent 11 is completed, the normal saline in the balloon is pumped out for decompression, and the balloon perfusion catheter is removed from the elephant trunk stent 11.

[0037] Compared with the existing retrograde femoral artery perfusion technique, the balloon perfusion catheter of the present invention significantly reduces the risks of complications such as intimal dissection, false lumen perfusion, thrombus and plaque shedding, not only improves the safety of the operation, but also improves the prognosis of the patient. By providing a clear surgical field of view, a stable operating environment and effective false lumen compression, it helps to improve the overall effect of the operation, enables the surgeon to suture and reconstruct more precisely, and at the same time promotes the complete thrombosis of the postoperative false lumen. The balloon perfusion catheter of the present invention has significant advantages in improving the safety, effectiveness and operational convenience of aortic dissection surgery.

[0038] The above are exemplary embodiments disclosed by the present invention. However, it should be noted that various changes and modifications can be made without departing from the scope of the embodiments disclosed by the present invention as defined by the claims. The functions, steps, and / or actions of the method claims according to the disclosed embodiments herein need not be performed in any specific order. In addition, although the elements disclosed by the embodiments of the present invention may be described or claimed in individual form, they can also be understood as plural unless explicitly limited to the singular.

[0039] Those of ordinary skill in the art should understand that: the discussion of any of the above embodiments is only exemplary, and is not intended to imply that the scope of the embodiments disclosed by the present invention (including the claims) is limited to these examples; under the idea of the embodiments of the present invention, the technical features between the above embodiments or different embodiments can also be combined, and there are many other variations in different aspects of the embodiments of the present invention as above, which are not provided in detail for the sake of brevity. Therefore, any omission, modification, equivalent replacement, improvement, etc. made within the spirit and principle of the embodiments of the present invention shall be included within the protection scope of the embodiments of the present invention.

Claims

1. A balloon perfusion catheter used during aortic dissection surgery, characterized in that, It includes a perfusion catheter body (1) and balloons evenly distributed on the outer periphery of the perfusion catheter body (1). The proximal end of the perfusion catheter body (1) is provided with a perfusion inlet (2), and the distal end is a perfusion outlet (3); there are three balloons distributed on the outer periphery of the perfusion catheter body (1). Among them, the proximal balloon is a blocking balloon (4), the middle balloon is a threaded balloon (5), and the distal balloon is a dilation balloon (6); each of the three balloons is connected to a water filling tube (7), and a three-way switch (8) is installed on each water filling tube (7) for independently controlling the inflation and decompression of each balloon.

2. The balloon perfusion catheter used during aortic dissection surgery according to claim 1, wherein, The perfusion catheter body (1) is a hollow pipe structure and is made of a flexible medical polymer material.

3. The balloon perfusion catheter used in aortic dissection surgery according to claim 2, wherein The perfusion inlet (2) at one end of the perfusion catheter body (1) is used to connect with the pipeline of an extracorporeal circulation machine.

4. The balloon perfusion catheter used in aortic dissection surgery according to claim 1, wherein, The total length of the perfusion catheter body (1) is 36 cm, and the inner diameter is 8 mm. Scale marks (9) are provided on the perfusion catheter body (1). The scale marks (9) are set at the proximal end of the perfusion catheter body (1). The scale marks (9) are the 11 - 30 cm scales marked on the outer periphery of the perfusion catheter body (1), with each centimeter as a grid, for positioning the position of the perfusion catheter body (1) in the elephant trunk stent.

5. The balloon perfusion catheter used during aortic dissection surgery according to claim 4, wherein The length of each balloon evenly distributed on the outer periphery of the perfusion catheter body (1) is 2.5 cm, the interval between balloons is 1 cm, and the distal end is left vacant for 0.5 cm.

6. The balloon perfusion catheter used during aortic dissection surgery according to claim 5, wherein, The three balloons are made of a medical polymer material.

7. The balloon perfusion catheter used during aortic dissection surgery according to claim 6, wherein, The surface of the threaded balloon (5) is provided with several circles of threads, which are used to stably fix the perfusion catheter, the elephant trunk stent and the aorta together, and block the reverse flow of blood from the gap between the elephant trunk stent and the aorta.

8. The balloon perfusion catheter used during aortic dissection surgery according to claim 7, characterized in that, The proximal balloon is located on the perfusion catheter body (1) on one side of the scale mark (9), and is used to completely block the retrograde flow of the perfusion blood flow in the elephant trunk stent to the operative field.

9. The balloon perfusion catheter used during aortic dissection surgery according to claim 8, wherein, The distal balloon is located on the perfusion catheter body (1) at the end of the perfusion outlet (3). The distance between the distal balloon and the perfusion outlet (3) is 0.5 cm, which is used to fully open the elephant trunk stent and at the same time partially block the retrograde flow of the perfusion blood flow.

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