Aortic cannula with controllability

Abstract

The invention relates to the technical field of medical instruments, in particular to an aortic cannula with controllability. Comprising a tube body including an insertion end; the first water bag is connected with the pipe body and surrounds the pipe body, and the space in the first water bag is independent of the space in the pipe body; the second water bag is connected with the pipe body and surrounds the pipe body, the space in the second water bag is independent of the space in the pipe body, and in the extending direction of the pipe body, the first water bag is close to the inserting end relative to the second water bag; wherein the insertion end and the first water bag are configured to be inserted into an incision, the first water bag is filled with water after being inserted into the incision, the pouch line is used for tightening the incision after the first water bag is inserted into the incision, the first water bag in the water filling state is close to the inner wall of the aorta under the action of blood pressure so as to seal the incision, and the second water bag is configured to be exposed outside the incision. The second water bag is filled with water after the first water bag is filled with water. The depth controllability, the fixing firmness and the sealing reliability of the aortic cannula are realized, and the surgical accident risk is reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a maneuverable aortic cannula. Background Technology

[0002] Establishing cardiopulmonary bypass (CPO) is a crucial technique in open-heart surgery, using a heart-lung machine to replace the function of the heart and lungs, maintaining the patient's blood circulation and oxygenation. Aortic cannulation is a vital step in establishing CPO, inserting a cannula into the aorta to maintain blood circulation and ensure blood supply to organs and tissues during surgery. This procedure is typically performed distal to the ascending aorta. After cannulation, the cannula is connected to the heart-lung machine, establishing an arterial pathway for CPO. Therefore, a controlled and reliable aortic cannulation is essential for the successful execution of open-heart surgery.

[0003] In the routine procedure of aortic cannulation, two concentric purse-string sutures are made on the distal wall of the ascending aorta. An incision is made in the center of the purse-string sutures, and the arterial cannula is inserted into the aortic lumen. The purse-string sutures are then immediately tightened and secured with a hemostat. Finally, the cannula is connected to the cardiopulmonary bypass machine. To prevent excessive insertion, a ring-shaped cannula is attached to the aortic cannula as a marker.

[0004] However, catheter fixation relies on manual fixation by the surgeon while another surgeon tightens the purse-string suture and locks the hemostat. Before the purse-string suture is tightened and secured, there is a high risk of the catheter accidentally dislodging due to the impact of blood pressure within the aorta, which could lead to massive bleeding. Secondly, relying on purse-string sutures to tighten the surrounding tissue of the catheter to achieve hemostasis is unreliable, especially when the aorta is dilated and the vessel wall is thin, making it prone to uncontrollable bleeding from the gap between the catheter and the aortic wall. The surgeon often has to re-suture the purse-string suture, which may still not achieve complete hemostasis, resulting in an obscured surgical field and affecting the operation. Therefore, ensuring that aortic catheterization achieves controllable insertion depth, secure fixation, and reliable sealing, while reducing the risk of surgical accidents, has become a technical problem that needs to be solved in clinical practice. Summary of the Invention

[0005] In order to solve the above-mentioned technical problems, or at least partially solve the above-mentioned technical problems, this application provides a maneuverable aortic cannula.

[0006] This application provides a maneuverable aortic cannula for use in cardiac surgery to connect the aorta and external circulation equipment through an incision in the aorta. The incision is sutured with a purse-string suture. The aortic cannula includes: a tube body with an insertion end; a first water-filled balloon connected to the tube body, the first water-filled balloon surrounding the tube body, and the space inside the first water-filled balloon being independent of the space inside the tube body; and a second water-filled balloon connected to the tube body, the second water-filled balloon surrounding the tube body, and the space inside the second water-filled balloon being independent of the space inside the tube body. In the extension direction of the tube body, the first water-filled balloon is closer to the insertion end than the second water-filled balloon. The insertion end and the first water-filled balloon are configured to be inserted into the incision. The first water-filled balloon is inflated with water after insertion into the incision. The purse-string suture is used to tighten the incision after the first water-filled balloon is inserted into the incision. In the inflated state, the first water-filled balloon, under the influence of blood pressure, approaches the inner wall of the aorta to seal the incision. The second water-filled balloon is configured to be exposed outside the incision. The second water-filled balloon is inflated with water after the first water-filled balloon is inflated.

[0007] In some embodiments, the aortic cannulation further includes a first tubing, a first pump body, a second tubing, and a second pump body. The first tubing connects a first water bladder and a first pump body, and the first pump body is used to pump water into the first water bladder through the first tubing. The second tubing connects a second water bladder and a second pump body, and the second pump body is used to pump water into the second water bladder through the second tubing.

[0008] In some embodiments, the operable aortic cannula further includes a pressure sensor and a controller. The pressure sensor is located in the first water bladder, and the controller is connected to the pressure sensor and the first pump body. The controller is used to control the first pump body to pump water into the first water bladder when the pressure value detected by the pressure sensor is greater than a pressure threshold.

[0009] In some embodiments, the pressure threshold ranges from 70 mmHg to 105 mmHg.

[0010] In some embodiments, the controller is connected to the second pump body, and the controller is used to control the second pump body to pump water into the second water bladder after controlling the first pump body to pump water into the first water bladder.

[0011] In some embodiments, the controller is connected to the second pump body, and the aortic cannula further includes a triggering device connected to the controller, which controls the second pump body to pump water into the second water bladder when it receives a trigger signal from the triggering device.

[0012] In some embodiments, when the first water bladder and the second water bladder are filled with water, the distance between the first water bladder and the second water bladder in the extension direction of the tube body is greater than or equal to 1 mm and less than or equal to 3.5 mm.

[0013] In some embodiments, the second water balloon is slidably connected to the tube body, and the aortic cannula further includes a locking component disposed on the second water balloon for locking the second water balloon onto the tube body.

[0014] In some embodiments, the diameter of the insertion end is D1, in Fr; the outer diameter of the first water bladder in the water-filled state is D2, in mm; and the range of D2 is greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3. The outer diameter of the second water bladder in the water-filled state is D3, in mm; and the range of D3 is greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3.

[0015] In some embodiments, the second water bladder is provided with a notch for avoiding the purse line.

[0016] In this embodiment, the aortic cannula, along with the first inflatable balloon, is inserted into the aortic lumen through an incision in the aorta during use. The first inflatable balloon is then inflated. At this time, the blood pressure within the aorta exerts pressure on the inflated balloon, directed towards the aortic wall. This causes the first inflatable balloon to press firmly against the inner wall of the aorta. On one hand, the inflated and compressed first inflatable balloon forms a contact seal with the inner wall of the aorta. This seal helps reduce blood leakage from the gap between the incision and the cannula. On the other hand, the first inflatable balloon acts as a mechanical anchor point located inside the blood vessel. This anchor point resists the tendency of blood pressure to push the cannula outward, thereby preventing accidental dislodgement of the cannula from the incision.

[0017] After inflating the first balloon and initially stabilizing the cannula, the surgeon tightens the pre-sutured purse-string suture. Tightening the purse-string suture further reduces the aortic incision and wraps it around the cannula. Subsequently, the second balloon, located lateral to the incision, is inflated.

[0018] After the second bladder is inflated, it expands on the outer wall of the aorta. At this point, the inflated first bladder is located on the inner wall of the aorta, and the inflated second bladder is located on the outer wall. The aortic wall is sandwiched between these two bladders. This structure creates a bilateral clamping effect. This clamping effect applies balanced pressure to the incision area from both the inner and outer sides of the vessel wall. This bidirectional clamping force can compensate for the inadequacy of relying solely on purse-string sutures for external tightening. For example, when aortic dilation leads to a thinner vessel wall, purse-string sutures may not be able to effectively tighten the opening, while the bilateral bladder structure achieves sealing of leakage gaps through large-area compression and sealing.

[0019] In summary, this application reduces the risk of cannula dislodgement and sealing risks during the pre-fixation stage by using a first water-filled balloon. Furthermore, the second water-filled balloon works synergistically with the first to reduce the probability of bleeding between the cannula and the aortic incision throughout the entire surgical procedure. This solves the technical problems existing in related technologies, achieving controllable depth of aortic cannulation, reliable fixation, and a secure seal, thus reducing the risk of surgical complications. Attached Figure Description

[0020] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application.

[0021] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the aortic cannulation structure described in the embodiments of this application; Figure 2 This is a schematic diagram of the aortic cannulation structure described in the embodiments of this application; Figure 3 This is a structural block diagram of the aortic cannulation described in the embodiments of this application.

[0023] in: 100-Aortic cannulation; 10-Cuticle body; 101-Insertion end; 20-First water balloon; 21-First tubing; 22-First pump body; 30-Second water balloon; 31-Second tubing; 32-Second pump body; 33-Notch; 40-Pressure sensor; 50-Controller; 60-Locking component; 70-Triggering device; 200-Aorta; 210-Incision; 300-Purple purse-string suture. Detailed Implementation

[0024] To better understand the above-mentioned objectives, features, and advantages of this application, the solution of this application will be further described below. It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0025] Many specific details are set forth in the following description in order to provide a full understanding of this application, but this application may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only some embodiments of this application, and not all embodiments.

[0026] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0027] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0028] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0029] To address the technical problems mentioned in the background section, this application combines... Figures 1 to 3 A maneuverable aortic cannulation method was proposed.

[0030] like Figure 1 and Figure 2As shown, the operable aortic cannula 100 provided in this embodiment is used in cardiac surgery to connect the aorta 200 and an external extracorporeal circulation device through an incision 210 on the aorta 200. A purse-string suture 300 is sutured around the incision 210. The aortic cannula 100 includes: a tube body 10, which includes an insertion end 101; a first water-filled balloon 20 connected to the tube body 10, the first water-filled balloon 20 surrounding the tube body 10, and the space inside the first water-filled balloon 20 being independent of the space inside the tube body 10; and a second water-filled balloon 30 connected to the tube body 10, the second water-filled balloon 30 surrounding the tube body 10, and the space inside the second water-filled balloon 30 being independent of the space inside the tube body 10. The space is independent of the space inside the tube 10. In the extension direction of the tube 10, the first water bladder 20 is closer to the insertion end 101 than the second water bladder 30. The insertion end 101 and the first water bladder 20 are configured to insert into the incision 210. The first water bladder 20 is inflated with water after being inserted into the incision 210. The purse-string suture 300 is used to tighten the incision 210 after the first water bladder 20 is inserted into the incision 210. The first water bladder 20 in the inflated state comes into contact with the inner wall of the aorta 200 under the action of blood pressure to seal the incision 210. The second water bladder 30 is configured to be exposed outside the incision 210. The second water bladder 30 is inflated with water after the first water bladder 20 is inflated.

[0031] In this embodiment, the tube body 10 is the main structure of the aortic cannula 100, used for blood delivery. The insertion end 101 is the end of the tube body 10 that needs to enter the aorta 200. The first water-filled balloon 20 and the second water-filled balloon 30 are two independently inflatable annular structures surrounding the tube body 10. The purse-string suture 300 is a suture sewn around the incision 210 in the aorta 200 to tighten the incision 210.

[0032] In this embodiment, the aortic cannula 100, when in use, has its insertion end 101 of the cannula 10 and the first water-filled balloon 20 inserted into the aortic lumen through the incision 210 on the aorta 200. Subsequently, the first water-filled balloon 20 is inflated. At this time, the blood pressure within the aorta 200 exerts pressure on the inflated first water-filled balloon 20. This pressure is directed towards the aortic wall. This causes the first water-filled balloon 20 to press tightly against the inner wall of the aorta 200. On one hand, the inflated and compressed first water-filled balloon 20 forms a contact seal with the inner wall of the aorta 200. This seal helps reduce blood leakage from the gap between the incision 210 and the cannula 10. On the other hand, the first water-filled balloon 20 acts as a mechanical anchor point located inside the blood vessel. This anchor point resists the tendency of blood pressure to push the cannula outward, thereby preventing the cannula from accidentally dislodging from the incision 210.

[0033] After the first inflatable balloon 20 is inflated and the cannulation is initially stabilized, the surgeon tightens the pre-sutured purse-string suture 300. Tightening the purse-string suture 300 further reduces the aortic incision 210 and wraps it around the tube body 10. Subsequently, the second inflatable balloon 30, located outside the incision 210, is inflated.

[0034] After the second water-filled bladder 30 is inflated, it expands on the outer wall of the aorta 200. At this time, the inflated first water-filled bladder 20 is located on the inner wall of the aorta 200, and the inflated second water-filled bladder 30 is located on the outer wall of the aorta 200. The aortic wall is sandwiched between the two water-filled bladders. This structure creates a bilateral clamping effect. This clamping effect applies balanced pressure to the incision area 210 from both the inner and outer sides of the vessel wall. This bidirectional clamping force can compensate for the inadequacy of relying solely on the purse-string suture 300 for external tightening. For example, when the aorta dilates and the vessel wall becomes relatively thin, the purse-string suture 300 may not be able to effectively tighten the opening, while the bilateral water-filled bladder structure achieves sealing of leakage gaps through large-area clamping and sealing.

[0035] In summary, this application reduces the risk of cannula dislodgement and bleeding during the pre-fixation stage by using the first water-filled balloon 20. Furthermore, the second water-filled balloon 30, working synergistically with the first balloon 20, reduces the probability of bleeding between the cannula and the aortic incision 210 throughout the entire surgical procedure. This solves the technical problems existing in related technologies, achieving controllable depth and secure fixation of the aortic cannula 100, improving the sealing reliability of the aortic cannula 100, and reducing the risk of surgical accidents.

[0036] like Figure 1 and Figure 2 As shown, in some embodiments of this application, the operable aortic cannula 100 further includes a first tubing 21, a first pump body 22, a second tubing 31, and a second pump body 32. The first tubing 21 connects the first water bladder 20 and the first pump body 22. The first pump body 22 is used to pump water into the first water bladder 20 through the first tubing 21. The second tubing 31 connects the second water bladder 30 and the second pump body 32. The second pump body 32 is used to pump water into the second water bladder 30 through the second tubing 31.

[0037] In this embodiment, the first pipe 21 is a flexible pipe connecting the first water bladder 20 and the first pump body 22. The first pump body 22 is a device capable of providing flow power for delivering water into the first water bladder 20 through the first pipe 21. The second pipe 31 is a flexible pipe connecting the second water bladder 30 and the second pump body 32. The second pump body 32 is also a device capable of providing flow power for delivering water into the second water bladder 30 through the second pipe 31. The first pump body 22 and the second pump body 32 are two independent components; they can each be two separate micro water pumps.

[0038] In a surgical setting, after the surgeon inserts the cannula into the aorta 200, the first water-filled balloon 20 needs to be inflated immediately. Manual inflating, such as using a syringe, may result in delays or inaccurate water volume. In this embodiment, the first pump 22 can be pre-set with a predetermined water volume and flow rate. Once activated, the first pump 22 rapidly and quantitatively supplies water to the first water-filled balloon 20 via the first tubing 21, thus shortening the time required for the balloon to reach its working state. The rapid inflating of the first water-filled balloon 20 allows for earlier sealing against the inner wall of the aorta 200, reducing the likelihood of the aortic cannula 100 dislodging. This improves the reliability of the aortic cannula 100's positioning depth and reduces the risk of surgical complications.

[0039] After tightening the purse-string 300 and confirming that the first water-filled bladder 20 has functioned, the second pump 32 is activated to inflate the second water-filled bladder 30. The independent control of the two pumps allows the doctor to precisely and independently control the timing and degree of inflation of the two water-filled bladders according to the actual situation at the surgical site.

[0040] The water supply system, consisting of two pumps and two pipelines, transforms the filling operation of the two water bags from manual to automated mode. This automated water supply mode reduces the number of steps and time required for doctors during the cannulation and fixation process, thereby improving surgical efficiency.

[0041] In summary, this embodiment simplifies the surgical procedure by providing an automated water supply solution, thereby reducing the difficulty of aortic cannulation 100 and optimizing the user experience of aortic cannulation 100.

[0042] like Figure 1 , Figure 2 and Figure 3 As shown, in some embodiments of this application, a pressure sensor 40 and a controller 50 are also included. The pressure sensor 40 is disposed in the first water bladder 20, and the controller 50 is connected to the pressure sensor 40 and the first pump body 22. The controller 50 is used to control the first pump body 22 to pump water into the first water bladder 20 when the pressure value detected by the pressure sensor 40 is greater than the pressure threshold.

[0043] In this embodiment, the pressure sensor 40 is a component capable of detecting physical pressure. It is mounted on or directly connected to the first water bladder 20 to monitor pressure changes in the environment surrounding the first water bladder 20 in real time. The controller 50 is a unit that processes signals and issues commands. It is electrically connected to the pressure sensor 40 and the first pump body 22.

[0044] When the unfilled first water-filled balloon 20 enters the aortic lumen through the incision 210, the high-pressure blood flow within the aorta 200 exerts pressure on the first water-filled balloon 20, which is detected by the pressure sensor 40. The controller 50 continuously acquires pressure readings from the pressure sensor 40 and compares them with a preset pressure threshold. This pressure threshold is set based on the normal range of blood pressure in the human aorta 200, and its purpose is to identify that the cannula is in a high-pressure environment inside the aorta 200. Once the detected pressure value exceeds the pressure threshold, the controller 50 determines that the first water-filled balloon 20 is located within the aorta 200 and exposed to blood pressure. Subsequently, the controller 50 automatically sends a start command to the first pump body 22, controlling the first pump body 22 to pump water into the first water-filled balloon 20 through the first tubing 21.

[0045] This automated control process replaces the manual judgment and initiation of water filling by the surgeon. The cumbersome operation from insertion of the aortic cannula 100 to fixation can increase the risk of surgical complications. This embodiment achieves rapid response of the first water balloon 20 through the pressure sensor 40 and controller 50, reducing delay time and thus improving the automation and usability of the aortic cannula 100, while reducing the risk of surgical complications.

[0046] In some embodiments of this application, the pressure threshold ranges from 70 mmHg to 105 mmHg.

[0047] In this embodiment, the pressure threshold ranges from 70 mmHg or greater to 105 mmHg or less. A millimeter of mercury (mmHg) is a unit of measurement for blood pressure.

[0048] This range is directly related to the blood pressure in the aorta 200. During open-heart surgery, even if the patient's blood pressure fluctuates, their mean arterial pressure is usually maintained within this physiological range. Setting the pressure threshold within this range ensures that the controller 50 can accurately identify, based on the pressure sensor 40, the critical state that the first water-filled balloon 20 has entered the aorta 200.

[0049] Specifically, the pressure threshold can be selected from several specific numerical points as examples. For instance, the pressure threshold can be set to 80 mmHg. This value is higher than some hypotensive states, helping to avoid false triggering. The pressure threshold can also be set to 90 mmHg. This value is close to the median mean arterial pressure for many patients, providing balanced response characteristics. The pressure threshold can also be set to 100 mmHg. This value ensures a rapid response even in patients with high blood pressure.

[0050] In summary, this embodiment ensures the reliability and effectiveness of the automatic control mechanism by limiting a pressure threshold that conforms to the physiological blood pressure characteristics of the human body, thereby achieving the technical effect of improving the positioning reliability of aortic cannulation 100 and reducing surgical risks.

[0051] like Figure 1 , Figure 2 and Figure 3 As shown, in some embodiments of this application, the controller 50 is connected to the second pump body 32, and the controller 50 is used to control the second pump body 32 to pump water into the second water bladder 30 after controlling the first pump body 22 to pump water into the first water bladder 20.

[0052] In this embodiment, the controller 50 is connected to the second pump body 32, and the controller 50 is configured to automatically control the second pump body 32 to pump water into the second water bladder 30 after completing the control of the first pump body 22.

[0053] This configuration establishes a sequential control logic that integrates the inflation of the two water-filled balloons from two independent actions into a coherent automated process. The process is as follows: First, pressure sensor 40 detects a pressure signal exceeding a pressure threshold. Based on this, controller 50 triggers the first pump 22 to inflate the first water-filled balloon 20, achieving deep and superficial anchoring and initial sealing within the aortic wall 200. Subsequently, without medical intervention, controller 50 automatically issues the next command, activating the second pump 32 to inflate the second water-filled balloon 30, thus forming a sandwich-like clamping and positioning effect in conjunction with the first water-filled balloon 20.

[0054] In summary, this embodiment achieves sequential automatic control of the first pump body 22 and the second pump body 32 through the controller 50, transforming the operation that required step-by-step manual execution into an automated control process, simplifying the surgeon's operation process, and ensuring that the first water balloon 20 and the second water balloon 30 can be activated quickly and reliably according to the design intent, thereby achieving the technical effect of improving the controllability of the depth of aortic cannulation 100 positioning and the reliability of sealing.

[0055] like Figure 2 As shown, in some embodiments of this application, the controller 50 is connected to the second pump body 32, and the aortic cannula 100 also includes a triggering device 70, which is connected to the controller 50. The controller 50 is used to control the second pump body 32 to pump water into the second water bag 30 when it receives a trigger signal from the triggering device 70.

[0056] In this embodiment, the controller 50 is connected to the second pump body 32. Furthermore, the aortic cannula 100 includes a triggering device 70, which is connected to the controller 50.

[0057] The trigger device 70 is a user-operated component that sends an electrical signal, i.e., a trigger signal, to the controller 50 when needed. The controller 50 is configured to issue a start command to the second pump body 32 only when it receives the trigger signal from the trigger device 70, thereby controlling the second pump body 32 to pump water into the second water bladder 30.

[0058] This setup designs the inflation of the second balloon 30 as a user-controlled process. In surgical scenarios, the automatic inflation of the first balloon 20 mitigates the risk of dislodgement during the initial stages of intubation. However, the timing of the final fixation and sealing of the second balloon 30 may require the surgeon to determine based on the specific circumstances. For example, the surgeon may need to observe the initial effects of the first balloon 20, adjust the intubation position, or handle other emergency procedures.

[0059] The triggering device 70 provides the physician with this decision-making and control. The physician can activate the inflation of the second water-filled balloon 30 by operating the triggering device 70 at the moment when everything is ready and most suitable for final fixation. This timing, controlled by the physician, ensures that the clamping effect of the second water-filled balloon 30 is established at the most precise moment.

[0060] Therefore, this embodiment, by introducing a user-controlled triggering device 70, provides flexibility and safety for the activation of the second water-filled balloon 30 while maintaining the safety advantage of the automatic response of the first water-filled balloon 20. This design makes the overall solution more adaptable to complex and ever-changing surgical realities, allowing the surgeon to maintain control over critical operations, thereby ensuring reliable fixation and effective sealing of the cannula in different surgical scenarios.

[0061] In one specific embodiment of this application, the triggering device 70 is configured to send two different signals to the controller 50: a trigger signal for initiating water filling and a release signal for initiating drainage.

[0062] The controller 50 is programmed to execute a drainage sequence when it receives a release signal from the trigger device 70. This sequence includes controlling the first pump 31 to draw water from the first water bladder 20 through the first pipe 41, and simultaneously or subsequently controlling the second pump 32 to draw water from the second water bladder 30 through the second pipe 42.

[0063] This function corresponds to the end stage of the operation. When the operation is completed and it is necessary to stop cardiopulmonary bypass and remove the aortic cannula 100, the first water balloon 20 and the second water balloon 30 must first be restored to the contracted state.

[0064] By sending a release signal through the trigger device 70, the controller 50 can automatically complete the drainage of the two water-filled balloons. This process replaces the potentially cumbersome manual pumping steps. After drainage, the dimensions of the first water-filled balloon 20 and the second water-filled balloon 30 are significantly reduced, and their outer diameter returns to a state close to that of the tube body 10. This allows the cannula to be smoothly removed from the aortic incision without causing accidental tissue damage to the vessel wall.

[0065] Therefore, this embodiment improves the management of the aortic cannula 100 by designing the controller 50 and the entire system with controlled drainage capacity. It not only focuses on fixation and sealing during cannulation, but also ensures safe and smooth removal of the cannula at the end of the surgery. This function further simplifies the surgeon's workflow and reduces the risk of tissue damage due to improper instrument removal, thereby improving the safety of the surgical procedure.

[0066] like Figure 2 As shown, in some embodiments of this application, when the first water bladder 20 and the second water bladder 30 are filled with water, the distance between the first water bladder 20 and the second water bladder 30 in the extending direction of the tube body 10 is greater than or equal to 1 mm and less than or equal to 3.5 mm.

[0067] In this embodiment, the distance range between the first water bladder 20 and the second water bladder 30 in the direction of extension along the tube 10 when they are filled with water is specified. This distance range is greater than or equal to 1 mm and less than or equal to 3.5 mm.

[0068] This distance range is directly related to the anatomical thickness of the aortic wall. In cardiac surgery, the thickness of the aortic wall varies from person to person and is affected by disease. Normal aortic wall thickness is typically between 1.5 mm and 2 mm. However, in cases of disease, such as aortic dissection or Marfan syndrome, aortic dilation leads to weakened vessel walls. The 1 mm to 3.5 mm spacing of the water-filled balloons in this protocol is designed to accommodate aortic walls ranging from normal to dilated and diseased, while also considering the thickness of the balloons themselves to prevent excessive compression that could cause accidental damage to the aortic wall or ineffective support leading to seal failure and bleeding.

[0069] Specifically, several values ​​can be selected for this distance as examples. For instance, the distance can be set to 1.5 mm. This distance is suitable for patients whose aortic walls are close to normal thickness or whose aortic dilation has resulted in weak vessel walls, enabling effective and moderate internal and external clamping. The distance can also be set to 2 mm. This distance is an intermediate value, providing a wider range of applications. The distance can also be set to 1 mm. This distance is mainly for cases where aortic dilation has resulted in weak vessel walls, ensuring that the two water balloons can cross the diseased vessel wall tissue, achieving stable clamping at a safe distance.

[0070] If the distance is too large, the clamping force of the water-filled balloon may not be effective in the incision area 210 when the aortic wall is thin. The distance range defined in this embodiment is intended to allow the two water-filled balloons to adapt to different anatomical and pathological conditions, thereby reliably forming bilateral support.

[0071] In summary, by limiting the aforementioned spacing, this embodiment improves the practicality of the aortic cannula 100, enhances the reliability of the first water balloon 20 and the second water balloon 30 in supporting the aortic wall, and thus achieves the technical effect of improving the practicality of the aortic cannula 100.

[0072] like Figure 2 As shown, in some embodiments of this application, the second water bladder 30 is slidably connected to the tube body 10, and the aortic cannula 100 further includes a locking component 60, which is disposed on the second water bladder 30 and is used to lock the second water bladder 30 onto the tube body 10.

[0073] In this embodiment, the second water balloon 30 is slidably connected to the tube body 10, meaning the second water balloon 30 can move along the extension direction of the tube body 10, changing its relative distance to the first water balloon 20. The aortic cannula 100 also includes a locking component 60. This locking component 60 is located on the second water balloon 30, and its function is to securely lock the second water balloon 30 to the tube body 10 after it has moved to the target position, preventing accidental displacement during the procedure.

[0074] This adjustable design is intended to accommodate anatomical differences in aortic wall thickness among different patients. In open-heart surgery, the aortic wall thickness is not constant. Certain pathological conditions can cause the actual thickness of the aortic wall to thin. If the position of the second bladder 30 is fixed, its distance from the first bladder 20 may not match the thinned vessel wall, resulting in a weakened clamping effect and affecting the sealing and fixation.

[0075] Through the cooperation of the sliding connection and locking component 60, the surgeon can make adjustments during the operation according to the actual situation. Specifically, after inserting the tube 10 into the aorta 200, the surgeon can slide the second water balloon 30 along the tube 10, bringing it as close as possible to the outer wall of the aorta 200, while maintaining a suitable clamping distance from the inner first water balloon 20. Once the position is determined, the locking component 60 is used to fix the second water balloon 30 in place. This adjustment process ensures that the second water balloon 30 is in the optimal working position regardless of whether the aortic wall is of normal thickness or pathologically thinned.

[0076] In summary, this embodiment improves the adaptability of the aortic cannula 100 to different patient anatomy and pathological changes by making the position of the second water balloon 30 adjustable. This ensures that the double water balloon sealing and fixation mechanism can be effectively established in a wider range of clinical situations, thereby achieving the technical effect of improving the controllability of the aortic cannula 100's positioning depth and the reliability of its seal.

[0077] In an alternative embodiment, the locking component 60 is a threaded knob rigidly connected to the second water bladder 30. Matching external threads are machined on the outer surface of the tube body 10 that contacts the second water bladder 30. When it is necessary to secure the second water bladder 30, rotating the knob utilizes the mechanical principle of the threaded pair to press the second water bladder 30 tightly against the tube body 10, generating significant static friction and thus achieving locking. Unlocking is achieved by rotating the knob in the opposite direction. This design is reliable, provides a secure lock, and allows for continuous fine-tuning of the position.

[0078] In an alternative embodiment, the locking component 60 is a clamping mechanism, such as a "hose clamp" structure. It comprises a metal band encircling the tube body 10, a locking screw, and a base connecting to the second water bladder 30. When the locking screw is tightened, the metal band contracts, tightly clamping the tube body 10 and generating a clamping force to prevent movement of the second water bladder 30. The advantage of this approach is that the clamping force is evenly distributed, minimizing the risk of damage to the surface of the tube body 10.

[0079] In an alternative embodiment, the locking component 60 is a ball bearing locator. It incorporates a spring and ball bearing structure within the second water bladder 30. Positioning recesses arranged axially are pre-machined at corresponding positions on the tube 10. When the second water bladder 30 slides to the target position, the ball bearing engages with the recess under the action of the spring, achieving positioning and locking through mechanical interlocking. For adjustment, applying a slightly larger axial force to the second water bladder 30 disengages the ball bearing from the recess. This design supports rapid, stepped adjustments with clear tactile feedback.

[0080] like Figure 2 As shown, in some embodiments of this application, the diameter of the insertion end 101 is D1, in Fr; the diameter of the first water bladder 20 in the water-filled state is D2, in mm; and the range of D2 is greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3. The outer diameter of the second water bladder 30 in the water-filled state is D3, in mm; and the range of D3 is greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3.

[0081] In this embodiment, the diameter D1 of the insertion end 101 is measured in Fr (French unit), which is a unit for measuring the diameter of tubular medical devices. 1 Fr is approximately equal to one-third of a millimeter. The diameter D2 of the first water bladder 20 in the inflated state is measured in millimeters (mm). The value range of D2 is limited to: greater than or equal to (D1÷3+4)×3, and less than or equal to (D1÷3+1+4)×3.

[0082] This size range is closely related to the actual surgical scenario of the aortic incision 210 at the aorta 200. During surgery, the incision 210 on the aorta 200 is slightly smaller than the outer diameter of the arterial cannula to ensure a tight fit after insertion. The cannula's diameter D1 roughly corresponds to its outer diameter in millimeters. For example, a cannula with a diameter of 7 mm has an outer diameter of approximately 7 × 3 = 21 mm. Therefore, D1 is calculated to be approximately three times the cannula's diameter in millimeters.

[0083] The 4 to 5 millimeters added to the formula is for purse-string suture considerations. The purse-string suture that the surgeon sutures on the aorta 200 is typically 4 to 5 millimeters larger in diameter than the outer diameter of the cannula. This expansion is necessary to allow for cannula insertion and provide tightening space. Therefore, the outer diameter D2 of the inflated balloon must be larger than the diameter of this purse-string suture to ensure that the inflated balloon can effectively cover and seal the entire incision area 210 from inside the aorta 200, preventing blood leakage from the gap between the purse-string suture and the cannula.

[0084] Meanwhile, the upper limit of the formula (D1÷3+1+4)×3 sets the maximum outer diameter of the bladder. This is to prevent the bladder from over-inflating. If the bladder is too large, it may excessively compress the aortic wall, affecting local blood flow, or occupy too much space within the aortic lumen, interfering with hemodynamics during cardiac systole. This upper limit strikes a balance between ensuring an effective seal and avoiding undue influence on the aorta.

[0085] For example, for an adult patient of standard weight, a 7mm diameter cannula (D1=7×3) might be selected. According to the formula, the outer diameter D2 of the first water-filled balloon 20 after inflation should be between 7×3+4=25mm and (7+1)×3+4=28mm. This size ensures that the water-filled balloon fully covers the incision 210 made for the 7mm diameter cannula and the purse-string suture area, achieving an effective seal.

[0086] Therefore, this embodiment uses the aforementioned mathematical relationships to correlate the working dimensions of the first water-filled balloon 20 with the cannulation specifications and standard surgical operating parameters. This ensures that the first water-filled balloon 20, after inflation, achieves a defined size that matches the patient's anatomy and surgical procedure, thereby improving the controllability of the aortic cannulation depth and the reliability of the seal.

[0087] In this embodiment, the outer diameter of the second water bladder 30 in the water-filled state is D3, and the unit is millimeters (mm). The numerical range of D3 is limited to: greater than or equal to (D1÷3+4)×3, and less than or equal to (D1÷3+1+4)×3.

[0088] This size range is closely related to the anatomy and surgical procedures outside the aortic incision 210 (200). Outside the aorta 200, a purse-string suture is made around the incision 210. The diameter of the purse-string is typically designed to be 4 to 5 millimeters larger than the outer diameter of the cannula. This increased range is necessary to allow for cannula insertion and provide tightening space.

[0089] After inflation, the second water-filled balloon 30 is positioned on the outer wall of the aorta 200. Its outer diameter D3 must be larger than the diameter of the purse-string suture. This ensures that the inflated second water-filled balloon 30 can fully cover and compress the entire purse-string suture area from the outside. This coverage ensures that potential leakage points between the purse-string suture and the cannula 10, as well as at the needle puncture site, are effectively sealed.

[0090] Meanwhile, the upper limit of the formula (D1÷3+1+4)×3 sets a maximum value for the outer diameter of the second water-filled balloon 30. This limit is to prevent the balloon from over-inflating. If the second water-filled balloon 30 is too large, it may excessively cover the tissues surrounding the outer wall of the aorta 200, hindering surgical procedures and causing unnecessary accidental compression damage. This upper limit strikes a balance between ensuring an effective external seal and avoiding accidental compression damage to surrounding tissues.

[0091] For example, for an adult patient of standard weight, a 7mm diameter (D1=7×3) cannula might be selected. According to the formula, the outer diameter (D3) of the second water-filled balloon 30 after inflation should be between 7×3+4=25mm and (7+1)×3+4=28mm. This size ensures that the second water-filled balloon 30 fully covers the purse-string suture area for the 7mm diameter cannula, achieving an effective external seal.

[0092] In summary, this embodiment uses the aforementioned mathematical relationships to correlate the working dimensions of the second water-filled balloon 30 with the cannulation specifications and standard surgical operating parameters. This ensures that the second water-filled balloon 30, after inflation, achieves a defined size that matches the patient's anatomy and surgical procedure, thereby improving the technical effects of controllable aortic cannulation depth and reliable sealing of the aortic cannulation 100.

[0093] like Figure 2 As shown, in some embodiments of this application, the second water bladder 30 is provided with a notch 33, which is used to avoid the purse line 300.

[0094] In this embodiment, a notch 33 is provided on the wall of the second water bladder 30. This notch 33 is a structural discontinuity or channel, and its specific function is to avoid the purse-string suture 300 pre-stitched on the aorta 200 when the second water bladder 30 is inflated with water.

[0095] In the surgical setting, the purse-string suture 300 is sutured around the aortic incision 210. Both ends of the suture extend from the incision 210 and connect to a hemostat. When the second bladder 30 inflates near the outer wall of the aorta 200, if it is a complete loop, the inflated bladder will press against the purse-string suture 300. This pressure may prevent the surgeon from tightening the incision 210 by pulling on the purse-string suture 300.

[0096] A notch 33 is provided in the second water-filled balloon 30 to provide a physical channel for the purse-string suture 300. When the second water-filled balloon 30 is inflated, most of its sac expands and contacts the outer wall of the aorta 200, forming a sealing surface. However, the location of the notch 33 allows the purse-string suture 300 to pass through, thus avoiding direct pressure from the water-filled balloon on the suture. This allows the purse-string suture 300 to remain free, ensuring that the physician can smoothly manipulate it to tighten the incision 210. At the same time, because the purse-string suture 300 is not compressed, its hemostatic function is preserved, and it works in conjunction with the water-filled balloon to achieve a seal in the incision area 210.

[0097] In summary, this embodiment solves the interference problem between the second water bladder 30 and the purse-string suture 300 by designing an avoidance notch 33 on the water bladder. This ensures that the water bladder sealing mechanism and the purse-string suture fixation mechanism do not interfere with each other, thereby achieving the technical effect of improving the practicality and reliability of the aortic cannulation 100.

[0098] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A maneuverable aortic cannula for connecting the aorta and an external circulatory device via an incision in the aorta during cardiac surgery, wherein the incision is sutured with purse-string sutures around its perimeter, characterized in that, include: The tube body includes an insertion end; A first water bladder is connected to the tube body, the first water bladder surrounds the tube body, and the space inside the first water bladder is independent of the space inside the tube body; The second water bladder is connected to the tube body. The second water bladder surrounds the tube body, and the space inside the second water bladder is independent of the space inside the tube body. In the extension direction of the tube body, the first water bladder is closer to the insertion end relative to the second water bladder. The insertion end and the first water bladder are configured to be inserted into the incision. The first water bladder is inflated with water after being inserted into the incision. The purse-string suture is used to tighten the incision after the first water bladder is inserted into the incision. The first water bladder in the inflated state comes into contact with the inner wall of the aorta under the action of blood pressure to seal the incision. The second water bladder is configured to be exposed outside the incision. The second water bladder is inflated with water after the first water bladder is inflated.

2. The aortic cannulation with controllability according to claim 1, characterized in that, It also includes a first pipeline, a first pump body, a second pipeline, and a second pump body. The first pipeline connects the first water bladder and the first pump body. The first pump body is used to pump water into the first water bladder through the first pipeline. The second pipeline connects the second water bladder and the second pump body. The second pump body is used to pump water into the second water bladder through the second pipeline.

3. The aortic cannulation with controllability according to claim 2, characterized in that, It also includes a pressure sensor and a controller. The pressure sensor is located in the first water bladder, and the controller is connected to the pressure sensor and the first pump body. The controller is used to control the first pump body to pump water into the first water bladder when the pressure value detected by the pressure sensor is greater than a pressure threshold.

4. The aortic cannulation with controllability according to claim 3, characterized in that, The pressure threshold range is greater than or equal to 70 mmHg and less than or equal to 105 mmHg.

5. The aortic cannulation according to claim 3, characterized in that, The controller is connected to the second pump body, and the controller is used to control the second pump body to pump water into the second water bladder after controlling the first pump body to pump water into the first water bladder.

6. The aortic cannulation with controllability according to any one of claims 1 to 5, characterized in that, The controller is connected to the second pump body, and the aortic cannula further includes a triggering device connected to the controller. The controller is used to control the second pump body to pump water into the second water bag when it receives a trigger signal from the triggering device.

7. The aortic cannulation with controllability according to any one of claims 1 to 6, characterized in that, When the first water bladder and the second water bladder are filled with water, the distance between the first water bladder and the second water bladder in the extension direction of the tube body is greater than or equal to 1 mm and less than or equal to 3.5 mm.

8. The aortic cannulation with controllability according to any one of claims 1 to 6, characterized in that, The second water-filled balloon is slidably connected to the tube body. The aortic cannula also includes a locking component, which is disposed on the second water-filled balloon and is used to lock the second water-filled balloon onto the tube body.

9. A maneuverable aortic cannulation according to any one of claims 1 to 6, characterized in that, The outer diameter of the insertion end is D1, in Fr, and the diameter of the first water bladder in the water-filled state is D2, in mm. The range of D2 is: greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3. The diameter of the second water bladder when it is filled with water is D3, in mm. The range of D3 is: greater than or equal to (D1÷3+4)×3 and less than or equal to (D1÷3+1+4)×3.

10. A controllable aortic cannulation according to any one of claims 1 to 6, characterized in that, The second water bladder has a notch, which is used to avoid the purse line.

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