A shunt stent system

Abstract

This invention discloses a shunt stent system, belonging to the field of medical device technology. The shunt stent system includes a stent shunt and a flow regulating structure. The stent shunt is positioned between the aneurysm cavity and the vein, and has a through-hole. The end of the shunt near the aneurysm cavity is the inlet, and the end near the vein is the outlet, connecting the aneurysm cavity, the shunt, and the vein to form a drainage channel, with blood flowing unidirectionally from the inlet to the outlet. The flow regulating structure is located within the shunt, and has a flow orifice communicating with the shunt. The flow regulating structure can adjust the effective flow cross-sectional area of ​​the flow orifice according to the pressure difference between the aneurysm cavity and the vein. When the pressure in the aneurysm cavity is high, increasing the effective flow cross-sectional area of ​​the flow orifice increases the blood flow, ensuring the drainage efficiency of the drainage channel, preventing further aneurysm expansion, reducing the risk of rupture, and improving applicability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shunt stent system. Background Technology

[0002] Endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) involves implanting a covered stent to isolate the diseased blood flow within the aneurysm, reducing stress on the aneurysm wall and thus mitigating the risk of aneurysm rupture. However, collateral blood flow can still continuously enter the aneurysm cavity post-operatively, easily triggering endoleak or type V endoleak corresponding to internal tension, leading to persistently high pressure within the aneurysm cavity, progressive enlargement of the aneurysm, and even rupture. Clinical data shows that the incidence of endoleak complications after EVAR is as high as 45%, representing a key challenge limiting the long-term efficacy of the procedure.

[0003] Existing technologies address the issue of high pressure within the aneurysm cavity after EVAR surgery by implanting a drainage channel between the aneurysm cavity and the inferior vena cava, artificially constructing an aorto-inferior vena cava fistula. This relies on the low-pressure properties of the vein to continuously relieve pressure within the aneurysm cavity, which can reduce the risk of aneurysm rupture to some extent. However, this approach still has drawbacks in clinical application: due to significant individual differences in postoperative aneurysm cavity pressure among patients, if the drainage channel's cross-sectional area is too small, the overall drainage efficiency of the channel remains insufficient under conditions of high pressure difference between the aneurysm cavity and the vein. This fails to effectively release the residual high pressure within the aneurysm cavity, making it difficult for the aneurysm to shrink, and the long-term risk of aneurysm enlargement and rupture remains. Summary of the Invention

[0004] The purpose of this invention is to provide a diversion support system that ensures the drainage efficiency of the drainage channel and improves its applicability.

[0005] To achieve this objective, the present invention adopts the following technical solution: A shunt support system, comprising: A stent shunt is disposed between the aneurysm cavity and the venous tube. The stent shunt has a through shunt orifice. The end of the shunt orifice near the aneurysm cavity is the inlet and the end near the venous tube is the outlet, so that the aneurysm cavity, the shunt orifice and the venous tube are connected to form a drainage channel, and blood flows unidirectionally from the inlet to the outlet. A flow regulating structure is provided within the diversion orifice. The flow regulating structure has a flow passage that communicates with the diversion orifice. The flow regulating structure can adjust the effective flow cross-sectional area of ​​the flow passage according to the pressure difference between the aneurysm cavity and the vein.

[0006] In some embodiments, the system further includes a detection element and a monitoring unit. The flow regulation structure includes an electrically adjustable valve. Both the detection element and the flow regulation structure are communicatively connected to the monitoring unit. The detection element detects the pressure in the aneurysm cavity and sends a signal back to the monitoring unit. The monitoring unit sends a command to the flow regulation structure based on the signal, causing the flow regulation structure to adjust the effective flow cross-sectional area of ​​the flow orifice.

[0007] In some embodiments, when the pressure within the aneurysm cavity is higher than a target upper limit, the flow regulating structure increases the effective flow cross-sectional area of ​​the flow orifice; when the pressure within the aneurysm cavity is lower than a target lower limit, the flow regulating structure decreases the effective flow cross-sectional area of ​​the flow orifice; when the pressure within the aneurysm cavity is higher than a dangerous upper limit, the flow regulating structure adjusts the effective flow cross-sectional area of ​​the flow orifice to a maximum value; and when the pressure within the aneurysm cavity is lower than a dangerous lower limit, the flow regulating structure adjusts the effective flow cross-sectional area of ​​the flow orifice to a minimum value.

[0008] In some embodiments, the orifice diameter ranges from 0 to 10 mm, and when the pressure within the aneurysm cavity is between the target upper limit and the target lower limit, the flow regulating structure adjusts the orifice diameter to 5 mm.

[0009] In some embodiments, the detection element can also detect the pressure of the venous tube and the flow rate of the drainage channel; When the pressure inside the aneurysm cavity is consistently higher than a preset pressure safety threshold, and the pressure inside the vein is normal, the flow regulation structure adjusts to increase the effective flow cross-sectional area of ​​the flow orifice. When the flow rate of the drainage channel exceeds the preset flow safety threshold, the flow rate adjustment structure adjusts and reduces the effective flow cross-sectional area of ​​the flow orifice.

[0010] In some embodiments, the stent shunt is an expandable covered stent, which is compressed in the delivery state and expanded in the release state. It includes a distal sealing portion, a main body segment, and a proximal sealing portion. The distal sealing portion has the inlet and is positioned within the aneurysm cavity, sealingly anchoring to the inner wall of the aneurysm cavity or the inner wall of the arterial tube. The proximal sealing portion has a flow orifice and is positioned within the venous tube, sealingly anchoring to the inner wall of the venous tube; and / or The monitoring unit is attached to the outer wall of the main body section; and / or The detection element includes a pressure sensor that detects the pressure in the aneurysm cavity. The pressure sensor is located within the shunt orifice and between the inlet and the flow regulation structure.

[0011] In some embodiments, the flow regulation structure adaptively changes the effective flow cross-sectional area of ​​the flow orifice according to the pressure difference between the aneurysm cavity and the vein.

[0012] In some embodiments, the flow regulating structure includes a balloon, the surface of which forms the flow passage, the balloon being capable of elastic deformation along the radial direction of the flow passage, the balloon contracting along the radial direction of the flow passage to increase the effective flow cross-sectional area of ​​the flow passage, and the balloon expanding along the radial direction of the flow passage to decrease the effective flow cross-sectional area of ​​the flow passage.

[0013] In some embodiments, the flow-through orifice is provided with a unidirectional flow structure, allowing blood to flow unidirectionally from the inlet to the outlet.

[0014] In some embodiments, the unidirectional conduction structure is located at the outlet, and the flow regulation structure is located upstream of the unidirectional conduction structure; and / or, The unidirectional flow structure includes at least two valve discs arranged circumferentially along the wall of the diversion orifice; the valve discs are elastic and are driven to open or close by the blood flow pressure difference on both sides. When blood flows from the inlet to the outlet, the valve discs open in the direction away from the inlet and separate from each other, thereby opening the unidirectional flow structure; when blood flows back in the opposite direction, the valve discs reset and close from each other.

[0015] The beneficial effects of this invention are: This invention provides a shunt stent system that places a stent shunt between the aneurysm cavity and the vein, connecting the aneurysm cavity, the through-hole, and the vein to form a one-way drainage channel. Because the shunt shunt has a flow regulation structure with a flow orifice, blood can flow from the aneurysm cavity to the vein through the flow orifice. Furthermore, the flow regulation structure can adjust the effective flow cross-sectional area of ​​the flow orifice to control the blood flow from the aneurysm cavity to the vein. When the pressure difference between the aneurysm cavity and the vein is high, increasing the effective flow cross-sectional area of ​​the flow orifice increases the blood flow from the aneurysm cavity to the vein, ensuring the drainage efficiency of the drainage channel. This effectively releases residual high pressure within the aneurysm cavity, causing the aneurysm to shrink, preventing further aneurysm expansion, reducing the risk of rupture, and decreasing the incidence of endoleaks and the need for secondary surgery. The flow regulation structure can adaptively adjust the effective flow cross-sectional area of ​​the flow orifice based on the pressure difference between the aneurysm lumen and the vein, establishing a controllable blood flow drainage channel between the aneurysm lumen and the vein. Therefore, it can adaptively adjust the postoperative aneurysm lumen pressure for different patients, effectively diverting blood from the aneurysm lumen to the low-pressure vein, significantly reducing the pressure within the aneurysm lumen, demonstrating good flexibility and applicability. Furthermore, by controlling the unidirectional flow of blood from the inlet to the outlet, it avoids high-pressure reflux in the vein, which could lead to increased pressure within the aneurysm lumen. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the shunt support system in use according to a specific embodiment of the present invention; Figure 2 This is a schematic diagram of a diversion support system provided by a specific embodiment of the present invention; Figure 3 This is a schematic diagram of the end face of a diversion support system provided in a specific embodiment of the present invention; Figure 4 This is a flowchart illustrating a method for adjusting the flow passage of a diversion support system according to a specific embodiment of the present invention; Figure 5 This is a schematic diagram of another diversion support system provided by a specific embodiment of the present invention.

[0017] In the picture: 100. Shunt stent system; 200. Aneurysm cavity; 300. Venous catheter; 400. Arterial catheter; 1. Support splitter; 101. Split flow orifice; 102. Inlet; 103. Outlet; 11. Distal sealing section; 12. Main body section; 13. Proximal sealing section; 2. Flow regulation structure; 21. Electric fine-tuning valve; 22. Balloon; 23. Flow passage orifice; 3. Test items; 4. Monitoring unit; 5. One-way conduction structure; 51. Valve disc. Detailed Implementation

[0018] To make the technical problems solved by the present invention, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0020] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0021] In the existing technology, since the flow cross-sectional area of ​​the drainage channel is constant, if the flow cross-sectional area of ​​the drainage channel is small, the overall drainage efficiency of the drainage channel is still insufficient under the condition of high pressure difference between the aneurysm cavity and the vein. It cannot effectively release the residual high pressure in the aneurysm cavity, making it difficult for the aneurysm to shrink. In the long term, there is still a safety hazard of aneurysm enlargement and rupture.

[0022] like Figures 1-5 As shown, this embodiment provides a shunt stent system, including a stent shunt 1 and a flow regulating structure 2. The stent shunt 1 is disposed between the aneurysm cavity 200 and the venous tube 300. The stent shunt 1 has a through shunt orifice 101. The end of the shunt orifice 101 near the aneurysm cavity 200 is the inlet 102, and the end near the venous tube 300 is the outlet 103, so that the aneurysm cavity 200, the shunt orifice 101 and the venous tube 300 are connected to form a drainage channel, and blood flows unidirectionally from the inlet 102 to the outlet 103. The flow regulating structure 2 is disposed in the shunt orifice 101 and has a flow passage 23 communicating with the shunt orifice 101. The flow regulating structure 2 can adjust the effective flow cross-sectional area of ​​the flow passage 23 according to the pressure difference between the aneurysm cavity 200 and the venous tube 300.

[0023] By placing the stent shunt 1 between the aneurysm cavity 200 and the venous tube 300, the aneurysm cavity 200, the shunt orifice 101, and the venous tube 300 are connected to form a one-way drainage channel. Because the shunt orifice 101 of the stent shunt 1 is equipped with a flow regulation structure 2 with a flow passage 23, blood can flow from the aneurysm cavity 200 to the venous tube 300 through the flow passage 23. Furthermore, the flow regulation structure 2 can adjust the effective flow cross-sectional area of ​​the flow passage 23, controlling the blood flow from the aneurysm cavity 200 to the venous tube 300. When the pressure difference between the aneurysm cavity and the vein is high, by increasing the effective flow cross-sectional area of ​​the flow passage 23, the blood flow from the aneurysm cavity 200 to the venous tube 300 is increased, ensuring the drainage efficiency of the drainage channel. This effectively releases the residual high pressure within the aneurysm cavity, causing the aneurysm to shrink, preventing further expansion of the aneurysm, reducing the risk of rupture, and decreasing the incidence of endoleak and the rate of secondary surgery. The flow regulation structure 2 can adaptively adjust the effective flow cross-sectional area of ​​the flow orifice 23 according to the pressure difference between the aneurysm cavity 200 and the vein 300, thus establishing a controllable blood flow drainage channel between the aneurysm cavity 200 and the vein 300. Therefore, it can adaptively adjust the postoperative aneurysm cavity pressure for different patients, effectively diverting blood from the aneurysm cavity to the low-pressure vein 300, significantly reducing the pressure within the aneurysm cavity, and exhibiting good flexibility and applicability. In addition, by controlling the unidirectional flow of blood from the inlet 102 to the outlet 103, it avoids high-pressure reflux in the vein 300 that could lead to an increase in pressure within the aneurysm cavity 200.

[0024] In one embodiment, the stent shunt 1 is an expandable covered stent, which is compressed in the delivery state and expanded in the release state. It includes a distal sealing part 11, a main body section 12 and a proximal sealing part 13. The distal sealing part 11 is provided with an inlet 102 and is placed in the aneurysm cavity 200 and is sealed and anchored with the inner wall of the aneurysm cavity 200 or the inner wall of the arterial tube 400. The proximal sealing part 13 is provided with an outlet 103 and is placed in the venous tube 300 and is sealed and anchored with the inner wall of the venous tube 300.

[0025] When the shunt stent system 100 is implanted, its distal end is positioned near the neck of the aneurysm via a cannula or guidewire, causing the distal sealing part 11 to expand and adhere to the inner wall of the arterial tube 400 or the inner wall of the aneurysm cavity 200, with the two sealed and anchored together; after the proximal end penetrates the venous tube 300 (such as the internal iliac vein or inferior vena cava), the proximal sealing part 13 expands and adheres to the inner wall of the venous tube 300, with the two sealed and anchored together, thereby establishing a drainage channel between the aneurysm cavity 200 and the venous tube 300. Optionally, the distal sealing portion 11, the main body 12, and the proximal sealing portion 13 of the stent shunt 1 are all self-expanding covered stents. The stent shunt 1 can self-expand to a preset diameter range after deployment to adapt to different vascular opening sizes and has axial expansion capability to adapt to different distances between the aneurysm cavity 200 and the vein 300, thereby achieving individualized adaptation to different patient anatomy structures and forming a stable drainage channel from the aneurysm cavity 200 to the vein 300. The specific covered stent structure and materials are based on existing technologies and will not be described in detail here. After expansion, the distal sealing portion 11 fits tightly against the aneurysm neck wall, preventing blood from leaking from the outer edge of the distal sealing portion 11. This ensures that blood in the aneurysm cavity 200 can only be drained through the internal flow port 101, resulting in a stable and reliable shunt and pressure relief effect. Relying on the self-expanding structure of the distal sealing portion 11 and the proximal sealing portion 13 for secure fixation, the stent shunt 1 is firmly anchored and not prone to displacement or slippage, improving the long-term implantation stability of the stent shunt 1.

[0026] In one embodiment, a one-way flow structure 5 is provided within the diversion orifice 101, allowing blood to flow unidirectionally from the inlet 102 to the outlet 103, permitting blood to flow only from the aneurysm cavity 200 to the vein 300, while preventing venous blood from flowing back into the aneurysm cavity 200. Exemplarily, the one-way flow structure 5 includes at least two valves 51 arranged circumferentially along the wall of the diversion orifice 101; the valves 51 are elastic and are driven to open or close by the pressure difference of blood flow on both sides. When the pressure within the aneurysm cavity 200 is greater than the pressure in the vein 300, and blood flows from the inlet 102 to the outlet 103, the valves 51 open towards the flow orifice 23 or away from the inlet 102, separating the valves 51 to open the one-way flow structure 5 and allow blood flow; when blood flows back in the opposite direction, the valves 51 reset, closing to block backflow and ensuring that blood flows only from the artery to the vein. A one-way flow structure 5 is located at the outlet 103, and a flow regulation structure 2 is located upstream of the one-way flow structure 5. This prevents backflow of blood from the vein 300 into the diversion orifice 101 from the outlet 103, the source, thus completely eliminating backflow. Specifically, the valve disc 51 is made of biological or polymeric materials and is connected to the inner wall of the diversion orifice 101. The specific structure of the valve disc 51 is based on existing technology.

[0027] like Figures 2-4As shown, in one embodiment, the shunt stent system 100 further includes a detection element 3 and a monitoring unit 4. The flow regulation structure 2 includes an electrically adjustable valve 21. Both the detection element 3 and the flow regulation structure 2 are communicatively connected to the monitoring unit 4. The detection element 3 detects the pressure of the aneurysm cavity 200 and feeds back a signal to the monitoring unit 4. The monitoring unit 4 sends a command to the flow regulation structure 2 based on the signal, causing the flow regulation structure 2 to adjust the effective flow cross-sectional area of ​​the flow orifice 23. Optionally, the electrically adjustable valve 21 is a micro-actuator fine-tuning valve, which is existing technology and will not be described in detail. When an abnormal increase in pressure is detected in the aneurysm cavity 200, the monitoring unit 4 can drive the micro-actuator fine-tuning valve to automatically increase the shunt flow; conversely, when the pressure is too low, the shunt flow is reduced to avoid excessive shunt.

[0028] Optionally, the detection element 3 includes a pressure sensor, which detects the pressure in the aneurysm cavity 200 in real time and feeds back the pressure signal to the monitoring unit 4. When the pressure is high, the monitoring unit 4 adjusts the flow orifice 23 to reduce the effective flow cross-sectional area, and when the pressure is low, the monitoring unit 4 adjusts the flow orifice 23 to increase the effective flow cross-sectional area, thereby realizing intelligent monitoring and control.

[0029] Optionally, the pressure sensor is located inside the shunt orifice 101 and between the inlet 102 and the flow regulating structure 2. Since the shunt orifice 101 is connected to the aneurysm cavity 200 and the pressure sensor is located close to the aneurysm cavity 200, the pressures of the two are the same or approximately the same, which can ensure the accuracy of pressure detection. The pressure sensor is implanted in the body with the stent shunt 1, which is convenient to operate and does not occupy the space of the aneurysm cavity 200, thus improving safety.

[0030] Optionally, the monitoring unit 4 is attached to the outer wall of the main body section 12. The monitoring unit 4, such as a chip, is implanted into the body along with the support diverter 1. The monitoring unit 4 has a built-in algorithm that automatically controls the opening of the flow adjustment structure 2's flow hole 23 according to the pressure.

[0031] Optionally, the pressure sensor is connected to the external monitoring unit 4 via a thin wire. The monitoring unit 4 has a built-in algorithm that automatically controls the opening of the flow regulating structure 2's flow orifice 23 based on the pressure. The external monitoring unit 4 also includes a display for continuously displaying the pressure in the aneurysm cavity 200 for real-time viewing.

[0032] The electrically adjustable valve 21, detection element 3, and monitoring unit 4 are powered and communicate via wireless or skin puncture microelectrodes. In intelligent mode, postoperative management can be more precise, further improving treatment safety and effectiveness.

[0033] In one embodiment, when the pressure within the aneurysm cavity 200 is higher than the target upper limit, such as 30 mmHg, the flow regulating structure 2 adjusts to increase the effective flow cross-sectional area of ​​the flow orifice 23; when the pressure within the aneurysm cavity 200 is lower than the target lower limit, such as 15 mmHg, the flow regulating structure 2 adjusts to decrease the effective flow cross-sectional area of ​​the flow orifice 23; when the pressure within the aneurysm cavity 200 is higher than the dangerous upper limit, such as 50 mmHg, the flow regulating structure 2 adjusts the effective flow cross-sectional area of ​​the flow orifice 23 to its maximum value; and when the pressure within the aneurysm cavity 200 is lower than the dangerous lower limit, such as 10 mmHg, the flow regulating structure 2 adjusts the effective flow cross-sectional area of ​​the flow orifice 23 to its minimum value.

[0034] Furthermore, excessive flow in the drainage channel can lead to abnormal fluctuations in systemic blood pressure. Therefore, the detection element 3 can also detect the pressure of the venous tube 300 and the flow in the drainage channel. When the pressure in the aneurysm cavity 200 is consistently higher than the preset safety threshold of 25 mmHg, and the pressure in the venous tube 300 is normal, the flow regulation structure 2 adjusts to increase the effective flow cross-sectional area of ​​the flow orifice 23. When the flow in the drainage channel is greater than the preset flow safety threshold, the flow regulation structure 2 adjusts to decrease the effective flow cross-sectional area of ​​the flow orifice 23. By detecting the pressure in the venous tube 300, it is possible to prevent excessive arterial blood from flowing into the vein, which could cause a surge in venous return and eliminate complications such as right ventricular overload and heart failure.

[0035] For example, the detection element 3 also includes a flow sensor, which is placed in the shunt orifice 101 and implanted into the body along with the stent shunt 1; the pressure of the venous tube 300 can be measured externally or internally, as per existing technology. By comprehensively judging the pressure of the aneurysm cavity 200, the pressure of the venous tube 300, and the drainage flow, the orifice diameter of the flow orifice 23 is adjusted to further improve reliability.

[0036] The orifice diameter of the flow passage 23 is in the range of 0-10 mm. When the pressure within the aneurysm cavity 200 is between the target upper limit and the target lower limit, the flow regulation structure 2 adjusts the orifice diameter of the flow passage 23 to 5 mm. Optionally, initially, the orifice diameter of the flow passage 23 is 5 mm, and by adjusting it between 0 and 10 mm, a suitable shunt flow rate can be obtained under a typical blood pressure gradient.

[0037] like Figure 4 As shown, in one embodiment, the method by which the monitoring unit 4 controls the flow regulation structure 2 to adjust the opening of the flow passage 23 includes: step S100, collecting the current pressure value of the aneurysm cavity 200 in real time through a pressure sensor installed on the side of the aneurysm cavity 200, and recording it as P; Step S200: The system internally presets four key pressure thresholds: target upper limit, target lower limit, danger upper limit, and danger lower limit. When the pressure in the aneurysm cavity 200 is higher than the danger upper limit of 50 mmHg, the flow regulating structure 2 adjusts the effective flow cross-sectional area of ​​the flow orifice 23 to the maximum value; when the pressure in the aneurysm cavity 200 is lower than the danger lower limit of 10 mmHg, the flow regulating structure 2 adjusts the effective flow cross-sectional area of ​​the flow orifice 23 to the minimum value.

[0038] When the pressure within the aneurysm cavity 200 exceeds the target upper limit, such as 30 mmHg, the flow regulation structure 2 increases the effective flow cross-sectional area of ​​the flow orifice 23; when the pressure within the aneurysm cavity 200 falls below the target lower limit, such as 15 mmHg, the flow regulation structure 2 decreases the effective flow cross-sectional area of ​​the flow orifice 23. Specifically, a strategy of segmented proportional regulation + integral separation + differential inhibition is adopted to adapt to the dynamic characteristics of aneurysm pressure changes, including the following steps: Step S210: Based on the magnitude of the pressure error, the state of the control orifice 23 is divided into four zones: safe zone (no adjustment or slow reduction of orifice diameter), fine adjustment zone (small increase / decrease of orifice diameter), adjustment zone (medium increase / decrease of orifice diameter), and rapid response zone (large increase / decrease of orifice diameter).

[0039] For example, the safety zone is set to 20 mmHg-25 mmHg. When the pressure detected by the detection element 3 is in this range, the flow orifice 23 may not be adjusted, or the orifice diameter of the flow orifice 23 may be slowly reduced.

[0040] The fine-tuning range is set to 15mmHg-20mmHg and 25mmHg-30mmHg. When the pressure detected by the detection element 3 is in this range, such as 15mmHg-20mmHg, the diameter of the flow passage 23 is slightly increased. When the pressure detected by the detection element 3 is in this range, such as 25mmHg-30mmHg, the diameter of the flow passage 23 is slightly decreased.

[0041] The adjustment range is set to 10mmHg-15mmHg and 30mmHg-50mmHg. When the pressure detected by the sensor 3 is in this range, such as 10mmHg-15mmHg, the diameter of the flow orifice 23 is increased by a moderate amount. When the pressure detected by the sensor 3 is in this range, such as 30mmHg-50mmHg, the diameter of the flow orifice 23 is decreased by a moderate amount.

[0042] The rapid response zone is set to be below 10 mmHg and above 50 mmHg. When the pressure detected by the sensor 3 is in this range, if it is below 10 mmHg, the diameter of the flow orifice 23 is significantly increased; when the pressure detected by the sensor 3 is in this range, if it is above 50 mmHg, the diameter of the flow orifice 23 is significantly decreased.

[0043] Step S220, Adjustment Step Calculation Formula: The aperture change ΔD(t) for each adjustment is determined by the following formula: Where K is the interval coefficient (between ±2), α is the proportional gain (0.05 mm / mmHg - 0.15 mm / mmHg), β is the differential gain (0.01 mm·s / mmHg - 0.03 mm·s / mmHg), and T is the differential gain (T). ref Let T be the reference time constant, e(t) be the pressure error, which is the difference between the current pressure and the target pressure, Δe(t) be the error rate of change, and T be the time constant. s To control the sampling period.

[0044] Step S300: Adjust the effective flow cross-sectional area of ​​the flow regulating structure 2 through the flow orifice 23.

[0045] Because K, α, β, T s and T ref All values ​​are constants, with the target pressure value being a preset constant. Currently, the pressure is measured using detector 3, so Δe(t) can be calculated. Based on the above formula, the adjustment step size ΔD(t) can be calculated, thus maintaining the pressure within the aneurysm cavity 200 within a preset safe range (20mmHg-35mmHg). When the pressure is too high, the opening of the flow orifice 23 automatically increases, allowing more blood to flow into the vein 300; when the pressure returns to normal, the opening automatically decreases to avoid excessive shunting. Blood flows along the pressure gradient between the artery and vein, reducing the blood flow resistance in the aneurysm cavity 200 and significantly reducing the pressure in the aneurysm cavity 200.

[0046] like Figure 5 As shown, in one embodiment, the flow regulation structure 2 adaptively changes the effective flow cross-sectional area of ​​the flow orifice 23 according to the pressure difference between the aneurysm cavity 200 and the vein 300. It is passively driven by the fluid pressure difference for regulation, without the need for external electrical control or manipulation components, which simplifies the overall structure of the shunt stent system 100 and facilitates minimally invasive implantation via catheter.

[0047] Optionally, the flow regulation structure 2 includes a balloon 22, the surface of which forms a flow passage 23. The balloon 22 is capable of elastic deformation along the radial direction of the shunt flow passage 101. The balloon 22 contracts radially along the shunt flow passage 101 to increase the effective flow cross-sectional area of ​​the flow passage 23, and expands radially along the shunt flow passage 101 to decrease the effective flow cross-sectional area of ​​the flow passage 23. Exemplarily, the balloon 22 is filled with a volume-compressible material, which can be any one or more combinations of the following: open-cell elastic sponge (such as medical polyurethane sponge) and porous high-elasticity polymer (such as silicone foam, polyester elastomer). When the pressure in the aneurysm cavity 200 increases: the higher blood pressure acts on the outer wall of the balloon 22, compressing the internal volume-compressible material, causing the balloon 22 to contract radially as a whole. When the pressure in the aneurysm cavity decreases: the pressure decreases, the compressed material recovers its original volume through its own elasticity, the balloon 22 re-expands radially, the effective flow cross-sectional area decreases, and the shunt flow rate decreases accordingly, avoiding excessive shunt flow that could cause fluctuations in systemic blood pressure.

[0048] Optionally, the balloon 22 is disposed inside the diversion channel 101, and the annular gap formed between the outer periphery of the balloon 22 and the inner wall of the diversion channel 101 is the flow passage 23. After the balloon 22 contracts towards the center of the diversion channel 101, the width of the annular gap between it and the inner wall of the diversion channel increases. After the balloon 22 expands in all directions, the width of the annular gap between it and the inner wall of the diversion channel decreases.

[0049] Optionally, the balloon 22 is annular and its periphery is attached to the wall of the diversion channel 101. The central through hole of the balloon 22 forms a flow hole 23. The balloon 22 contracts towards the wall of the diversion channel, which increases the diameter of the central through hole, i.e., increases the effective flow cross-sectional area. After the balloon 22 expands towards the center of the diversion channel 101, the diameter of the central through hole decreases, i.e., the effective flow cross-sectional area decreases.

[0050] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A shunt support system, characterized in that, include: A stent shunt (1) is disposed between the aneurysm cavity (200) and the venous tube (300). The stent shunt (1) is provided with a through shunt orifice (101). The end of the shunt orifice (101) near the aneurysm cavity (200) is the inlet (102), and the end near the venous tube (300) is the outlet (103). This allows the aneurysm cavity (200), the shunt orifice (101), and the venous tube (300) to be connected to form a drainage channel, and blood flows unidirectionally from the inlet (102) to the outlet (103). A flow regulating structure (2) is provided in the diversion orifice (101). The flow regulating structure (2) is provided with a flow passage (23) communicating with the diversion orifice (101). The flow regulating structure (2) can adjust the effective flow cross-sectional area of ​​the flow passage (23) according to the pressure difference between the aneurysm cavity (200) and the vein (300).

2. The diversion support system according to claim 1, characterized in that, It also includes a detection element (3) and a monitoring unit (4). The flow regulation structure (2) includes an electric fine-tuning valve (21). Both the detection element (3) and the flow regulation structure (2) are communicatively connected to the monitoring unit (4). The detection element (3) detects the pressure of the aneurysm cavity (200) and feeds back a signal to the monitoring unit (4). The monitoring unit (4) sends a command to the flow regulation structure (2) based on the signal, so that the flow regulation structure (2) adjusts the effective flow cross-sectional area of ​​the flow passage (23).

3. The diversion support system according to claim 2, characterized in that, When the pressure inside the aneurysm cavity (200) is higher than the target upper limit, the flow regulating structure (2) increases the effective flow cross-sectional area of ​​the flow orifice (23); when the pressure inside the aneurysm cavity (200) is lower than the target lower limit, the flow regulating structure (2) decreases the effective flow cross-sectional area of ​​the flow orifice (23); when the pressure inside the aneurysm cavity (200) is higher than the dangerous upper limit, the flow regulating structure (2) adjusts the effective flow cross-sectional area of ​​the flow orifice (23) to the maximum value. When the pressure inside the aneurysm cavity (200) is lower than the danger limit, the flow regulation structure (2) adjusts the effective flow cross-sectional area of ​​the flow orifice (23) to the minimum value.

4. The diversion support system according to claim 3, characterized in that, The orifice (23) has a diameter range of 0-10 mm. When the pressure in the aneurysm cavity (200) is between the target upper limit and the target lower limit, the flow regulating structure (2) adjusts the orifice (23) to 5 mm.

5. The shunt support system according to claim 3, characterized in that, The detection element (3) can also detect the pressure of the vein (300) and the flow rate of the drainage channel; When the pressure in the aneurysm cavity (200) is consistently higher than the preset pressure safety threshold, and the pressure in the vein (300) is normal, the flow regulation structure (2) adjusts to increase the effective flow cross-sectional area of ​​the flow orifice (23); When the flow rate of the drainage channel is greater than the preset flow safety threshold, the flow rate adjustment structure (2) adjusts to reduce the effective flow cross-sectional area of ​​the flow passage (23).

6. The diversion support system according to claim 5, characterized in that, The stent shunt (1) is an expandable covered stent, which is compressed in the delivery state and expanded in the release state. It includes a distal sealing part (11), a main body (12), and a proximal sealing part (13). The distal sealing part (11) is provided with the inlet (102). The distal sealing part (11) is placed in the aneurysm cavity (200) and is sealed and anchored with the inner wall of the aneurysm cavity (200) or the inner wall of the arterial tube (400). The proximal sealing part (13) is provided with a flow hole (23). The proximal sealing part (13) is located in the venous tube (300) and is sealed and anchored with the inner wall of the venous tube (300); and / or The monitoring unit (4) is attached to the outer wall of the main body section (12); and / or The detection element (3) includes a pressure sensor that detects the pressure in the aneurysm cavity (200). The pressure sensor is located in the diversion orifice (101) and between the inlet (102) and the flow regulation structure (2).

7. The diversion support system according to claim 1, characterized in that, The flow regulation structure (2) adaptively changes the effective flow cross-sectional area of ​​the flow orifice (23) according to the pressure difference between the aneurysm cavity (200) and the vein (300).

8. The diversion support system according to claim 7, characterized in that, The flow regulation structure (2) includes a balloon (22), the surface of which forms the flow passage (23). The balloon (22) is capable of elastic deformation along the radial direction of the diversion flow passage (101). The balloon (22) contracts along the radial direction of the diversion flow passage (101) to increase the effective flow cross-sectional area of ​​the flow passage (23), and the balloon (22) expands along the radial direction of the diversion flow passage (101) to decrease the effective flow cross-sectional area of ​​the flow passage (23).

9. The shunt support system according to any one of claims 1-8, characterized in that, The flow-through orifice (101) is provided with a one-way flow structure (5) so that blood can flow unidirectionally from the inlet (102) to the outlet (103).

10. The shunt support system according to claim 9, characterized in that, The unidirectional flow structure (5) is located at the outlet (103), and the flow regulation structure (2) is located upstream of the unidirectional flow structure (5); and / or, The unidirectional flow structure (5) includes at least two valve discs (51) arranged circumferentially along the wall of the diversion orifice (101); the valve discs (51) are elastic and are driven to open or close by the blood flow pressure difference on both sides. When blood flows from the inlet (102) to the outlet (103), the valve discs (51) open in the direction away from the inlet (102) and the valve discs (51) separate to realize the opening of the unidirectional flow structure (5); when blood flows back in the opposite direction, the valve discs (51) reset and the valve discs (51) close.

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