Non-implanted atrial shunt device

Abstract

The present application relates to the technical field of medical equipment, in particular to a radio frequency assembly for a non-implanted atrial shunt device and the non-implanted atrial shunt device, the radio frequency assembly for the non-implanted atrial shunt device comprising: a balloon, the balloon having an ablation working state of being inflated after being inflated with a medium and an ordinary state of not being inflated with the medium; an ablation electrode arranged on the balloon, the ablation electrode being in contact with a surface of a foramen ovale puncture hole to form a foramen ovale; and a cooling medium outlet arranged on the surface of the balloon, and the cooling medium outlet being located at an ablation position of the ablation electrode.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a radio frequency component for a non-implantable atrial shunt device and a non-implantable atrial shunt device. Background Technology

[0002] Heart failure is a common and potentially fatal disease in humans, and despite the best efforts of hospitals, it is often difficult to control and cure in clinical practice. In particular, the incidence of heart failure with preserved ejection fraction (HFpEF) has increased significantly in recent years, but its treatment remains a challenge for clinicians.

[0003] The current treatment involves puncturing the atrial septum to create a hole and drain blood pressure from the left atrium to the right atrium, thereby reducing left atrial hypertension and effectively improving "heart failure with preserved ejection fraction".

[0004] Non-implantable atrial shunts are required during atrial septal puncture. These shunts are designed to extend the ablation zone deeper into the tissue during radiofrequency ablation, thereby delaying tissue healing. However, existing non-implantable atrial shunts cannot effectively extend the ablation zone deeper into the tissue, failing to meet the requirement of delaying tissue healing. Summary of the Invention

[0005] The technical problem to be solved by this invention is to overcome the poor ability of existing radiofrequency components to extend the thermal ablation range into deeper layers of tissue during radiofrequency ablation, which fails to meet the requirements of medical professionals for delayed tissue healing. To solve the above problem, this invention provides a radiofrequency component for a non-implantable atrial shunt device, comprising:

[0006] The balloon has an ablation working state in which it expands after being filled with a medium, and a normal state in which the balloon is not filled with a medium.

[0007] An ablation electrode is disposed on the balloon and contacts the surface of the atrial septum puncture hole to form an atrial septum puncture hole; a cooling medium outlet is provided on the surface of the balloon and the cooling medium outlet is located at the ablation position of the ablation electrode.

[0008] Optionally, the balloon includes: a limiting portion that abuts against the interatrial septum in the ablation working state, and an ablation portion provided with the ablation electrode, the ablation portion being disposed on the side of the limiting portion near the catheter assembly; and, in the ablation working state, the diameter of the limiting portion is larger than the diameter of the ablation portion;

[0009] The cooling medium outlet is located in the ablation section.

[0010] Optionally, in the ablation working state, the limiting part is an elliptical spherical structure; and / or,

[0011] In the ablation working state, the ablation part has a straight cylindrical structure.

[0012] Optionally, the cooling medium outlets are evenly and densely distributed in the circumferential direction and along the length direction of the ablation part surface.

[0013] Optionally, the ablation electrode includes: a plurality of electrode sheets extending along the length of the ablation portion and distributed in the circumferential direction of the ablation portion;

[0014] The cooling medium outlet is arranged on the electrode plate; and / or, the cooling medium outlet is arranged on the ablation portion between adjacent electrode plates.

[0015] Optionally, the electrode pad includes: a working section that contacts the surface of the atrial septal puncture hole to form an atrial septal perforation, an insulating section extending toward the catheter assembly, and an extension section extending into the catheter assembly;

[0016] The cooling medium outlets are evenly distributed on the working section.

[0017] Optionally, the electrode sheet is fixed to the surface of the ablation zone by means of flexible circuit printing.

[0018] A non-implantable atrial shunt device, comprising:

[0019] Radiofrequency components for non-implantable atrial shunt devices; and

[0020] A catheter assembly for filling the balloon with a medium.

[0021] Optionally, the inner and middle tubes of the catheter assembly form a pressure conduit for injecting a medium into the balloon;

[0022] The central tube is also provided with a cooling medium injection port that communicates with the balloon.

[0023] Optionally, the cooling medium injection port is located on the side of the central tube adjacent to the ablation electrode.

[0024] Optionally, the pressure conduit is used to contain cold saline solution; or, the pressure conduit is used to contain a developing solution of cold saline solution and contrast agent.

[0025] Optionally, a marking ring is also provided on the central tube, which is visible under X-ray to indicate the position of the ablation electrode.

[0026] The technical solution of this invention has the following advantages:

[0027] 1. The radiofrequency assembly for a non-implantable atrial shunt device of the present invention comprises: a balloon having an ablation working state in which it expands after being filled with a medium, and a normal state in which the balloon is not filled with a medium; an ablation electrode disposed on the balloon, the ablation electrode contacting the surface of an atrial septal puncture hole to form an atrial septal perforation; and a cooling medium outlet disposed on the surface of the balloon, the cooling medium outlet being located at the ablation position of the ablation electrode.

[0028] In this invention, a cooling medium outlet is provided on the surface of the balloon, which can effectively spray a cooling medium such as cold saline onto the ablation site of the ablation electrode. Since electrode temperature indirectly reflects whether the tissue temperature is sufficient to denature proteins and cause damage, if the tissue temperature is not high enough, more energy output is required; if the tissue temperature is too high, adverse events may occur, requiring a reduction in energy output. The cooling medium such as cold saline sprayed from the outlet can actively flush the ablation electrode with physiological saline during the ablation process, thereby reducing the temperature of the tip electrode. This cooling medium can lower the temperature of the ablation electrode, preventing localized overheating and blood crusting, thus allowing the ablation electrode to work more continuously and increasing the depth of heat conduction.

[0029] 2. The radio frequency assembly for a non-implantable atrial shunt device of the present invention has cooling medium outlets uniformly and densely distributed in the circumferential direction and extending along the length direction of the ablation portion surface.

[0030] The uniformly distributed cooling medium outlets can effectively spray cold saline and other cooling media toward the surface of the ablation area, thereby uniformly and effectively reducing the temperature of the ablation electrode tip and avoiding local overheating of the ablation electrode, thus preventing blood crusting. This allows the ablation electrode to work for longer periods and increases the depth of heat conduction.

[0031] 3. The radiofrequency assembly for a non-implantable atrial shunt device of the present invention, wherein the ablation electrode comprises: a plurality of electrode pads extending along the length direction of the ablation portion and distributed in the circumferential direction of the ablation portion; the cooling medium outlet is disposed on the electrode pads; and / or, the cooling medium outlet is disposed on the ablation portion between adjacent electrode pads.

[0032] In this invention, the electrode pads of the radiofrequency assembly are designed as separate units. This allows for regional damage to the atrial septum tissue surrounding the puncture site during radiofrequency ablation after puncture of the atrial septum assembly. As the balloon expands and damages the atrial septum assembly, the puncture site extends circumferentially, effectively reducing radial tearing and improving the quality of the puncture site formation, which is beneficial for the patient's later recovery. Furthermore, in existing technologies, the annular electrode pad is fitted outside the limiting balloon. During balloon inflation and deflation, the balloon's volume changes rapidly. Because the electrode pad's hardness is much higher than the balloon's, excessive stress during balloon contraction and expansion can cause cracks in the electrode pad, leading to uneven ablation of the atrial septum tissue. In this invention, by using multiple electrode pads, the stress experienced during balloon inflation and deflation is greatly reduced, minimizing the possibility of electrode pad damage and extending their lifespan. More importantly, in this invention, arranging the cooling medium outlet on the ablation section between the electrode sheet and the adjacent electrode sheet can further ensure that the cooling medium such as cold brine is sprayed evenly, and ensure that each part of the ablation section can be effectively cooled.

[0033] 4. The radiofrequency assembly for a non-implantable atrial shunt device of the present invention, wherein the electrode pads are fixed to the surface of the ablation part by means of flexible circuit printing.

[0034] In this invention, flexible circuit printing technology is used to print conductive materials such as electrode sheets onto the surface of a balloon. The electrode sheet thickness and flexibility of the balloon formed by the above process can be significantly improved, allowing for smaller catheter shrinkage dimensions and thus reducing catheter diameter and surgical trauma. At the same time, the flexible circuit printing can also create a wide variety of electrode shapes, better matching surgical needs.

[0035] 5. The non-implantable atrial shunt device of the present invention, wherein the inner tube and the middle tube of the catheter assembly form a pressure conduit for injecting a medium into the balloon; the middle tube is further provided with a cooling medium infusion port communicating with the balloon.

[0036] By setting a cooling medium injection port on the central tube that is connected to the balloon, it is possible to effectively ensure that cooling media such as cold brine can enter the balloon and be discharged from the cooling medium outlet on the surface of the balloon, thereby increasing the depth of heat conduction.

[0037] 6. In the non-implantable atrial shunt device of the present invention, the cooling medium infusion port is disposed on one side of the central tube adjacent to the ablation electrode.

[0038] By setting the cooling medium inlet on one side of the adjacent ablation electrode, it can be ensured that during the discharge of cooling medium such as cold saline through the cooling medium outlet, there will be no problem of insufficient pressure medium in the balloon causing deformation of the balloon, which would prevent the balloon from accurately achieving the locking and limiting function. This ensures that the ablation electrode and the surface of the interatrial septum puncture hole are in full contact and will not be misaligned.

[0039] 7. The non-implantable atrial shunt device of the present invention, wherein the pressure conduit is used to contain cold saline; or, the pressure conduit is used to contain a contrast agent mixture of cold saline and a contrast agent. A marking ring is also provided on the central tube, the marking ring being visible under X-ray to indicate the position of the ablation electrode.

[0040] In this invention, mixing cold saline with a contrast agent can effectively help the marker ring to be visualized under X-ray, thereby indicating the location of the ablation electrode.

[0041] 8. The non-implantable atrial shunt device of the present invention, wherein the balloon comprises: a limiting portion abutting against the atrial septum in the ablation working state, and an ablation portion having the ablation electrode, the ablation portion being disposed on the side of the limiting portion near the catheter assembly; and, in the ablation working state, the diameter of the limiting portion is larger than the diameter of the ablation portion; and the cooling medium outlet is disposed in the ablation portion.

[0042] In this invention, the method by which medical professionals operate a non-implantable atrial shunt device is altered by positioning the ablation electrode on the side of the balloon closer to the catheter assembly. During operation, the medical professional drives the balloon into the left atrium, advancing it a distance beyond the contact point between the ablation electrode and the atrial septal puncture site. The medical professional then inflates the balloon by filling it with a medium. Once inflated, the medical professional pulls the balloon back, at which point it contacts the outer edge of the atrial septal puncture site. The medical professional will feel resistance, indicating that the balloon has reached its limit position and the ablation electrode is in contact with the surface of the atrial septal puncture site. In this state, the ablation electrode is in contact with the surface of the atrial septal puncture site, and the ablation electrode has reached the designated position. By placing the ablation electrode on the side of the balloon closer to the catheter assembly, medical staff can determine by touch whether the balloon is properly secured, ensuring that the balloon is accurately positioned on the atrial septum tissue. This allows the ablation electrode to make accurate relative contact with the surface of the atrial septum puncture site, effectively guaranteeing accurate ablation of the atrial septum puncture site surface without causing damage to other areas. Attached Figure Description

[0043] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0044] Figure 1 A three-dimensional structural schematic diagram of the radio frequency component for a non-implantable atrial shunt device provided by the present invention;

[0045] Figure 2 This is a schematic diagram showing the location of the cooling medium outlet on the balloon provided by the present invention;

[0046] Figure 3 A schematic diagram of the connection structure between the balloon, ablation electrode, and catheter assembly provided by the present invention;

[0047] Figure 4 This is a schematic diagram of the structure of the working section, insulating section and extension section of the electrode sheet provided by the present invention.

[0048] Figure 5 This is a schematic diagram illustrating the usage of the non-implantable atrial shunt device provided by the present invention.

[0049] Explanation of reference numerals in the attached figures:

[0050] 1-Balloon; 2-Ablation electrode; 3-Cooling medium outlet; 4-Limiting part; 5-Ablation part; 6-Catheter assembly; 7-Working section; 8-Insulating section; 9-Extension section; 10-Inner tube; 11-Middle tube; 12-Pressure pipe; 13-Cooling medium inlet; 14-Outer sheath; 15-Marking ring. Detailed Implementation

[0051] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0052] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," 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 the invention and for 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 the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0053] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed 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 of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0054] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0055] Example 1

[0056] The radio frequency component for non-implantable atrial shunt devices in this embodiment, such as Figure 1 and Figure 2 As shown, it includes:

[0057] The balloon 1 has an ablation working state where it expands after being filled with a medium, and a normal state where it is not filled with a medium; for example... Figure 1 As shown, the balloon 1 includes: a limiting part 4 that abuts against the interatrial septum in the ablation working state, and an ablation part 5 provided with the ablation electrode 2, the ablation part 5 being disposed on the side of the limiting part 4 near the catheter assembly 6; and, in the ablation working state, the diameter of the limiting part 4 is larger than the diameter of the ablation part 5; the cooling medium outlet 3 is disposed in the ablation part 5; in this embodiment, in the ablation working state, the limiting part 4 is an elliptical spherical structure; in the ablation working state, the ablation part 5 is a straight cylindrical structure;

[0058] An ablation electrode 2 is disposed on the balloon 1, and the ablation electrode 2 contacts the surface of the atrial septum puncture hole to form an atrial septum puncture hole. A cooling medium outlet 3 is disposed on the surface of the balloon 1, and the cooling medium outlet 3 is located at the ablation position of the ablation electrode 2. In this invention, by providing a cooling medium outlet 3 on the surface of the balloon 1, the cooling medium outlet 3 can effectively spray a cooling medium such as cold saline onto the ablation position of the ablation electrode 2. Because electrode temperature can indirectly reflect whether the tissue temperature is sufficient to denature proteins and cause damage, if the tissue temperature is not high enough, more energy output is required; if the tissue temperature is too high, adverse events may occur, requiring a reduction in energy output. The cooling medium such as cold saline sprayed from the cooling medium outlet 3 can actively flush the ablation electrode 2 with physiological saline or other media during the ablation process, thereby reducing the temperature of the tip electrode. The aforementioned cooling medium, such as cold saline, can lower the temperature of the ablation electrode 2, preventing localized overheating and blood crusting. This allows the ablation electrode 2 to operate more continuously and increases the depth of heat conduction. Cooling medium outlets 3 are evenly distributed along the circumferential direction and length of the ablation portion 5. The ablation electrode 2 includes multiple electrode plates extending along the length of the ablation portion 5 and distributed along its circumferential direction. The cooling medium outlets 3 are arranged on the electrode plates and between adjacent electrode plates in the ablation portion 5. In this invention, arranging the cooling medium outlets 3 on the electrode plates and between adjacent electrode plates in the ablation portion 5 further ensures uniform spraying of the cooling medium, ensuring effective cooling of all parts of the ablation portion 5. The electrode plates are fixed to the surface of the ablation portion 5 using flexible circuit printing.

[0059] In this embodiment, as Figure 3 and Figure 4 As shown, the electrode includes: a working section 7 that contacts the surface of the interatrial septum puncture hole to form an interatrial septum puncture hole, an insulating section 8 extending toward the catheter assembly 6, and an extension section 9 extending into the catheter assembly 6; the cooling medium outlet 3 is uniformly arranged on the working section 7.

[0060] Of course, this embodiment does not specifically limit the cooling medium. In other embodiments, the cooling medium may also be a cooling gas or other liquid medium.

[0061] Of course, this embodiment does not specifically limit the location of the cooling medium outlet 3. In other embodiments, the cooling medium outlet 3 is inclined toward the ablation part 5.

[0062] Example 2

[0063] A non-implantable atrial shunt device, such as Figure 5As shown, it includes:

[0064] Radio frequency components;

[0065] The catheter assembly 6 is used to inflate the balloon 1 with a medium. For example... Figure 1 As shown, the inner tube 10 and the middle tube 11 of the catheter assembly 6 form a pressure conduit 12 for injecting media into the balloon 1. The middle tube 11 is also provided with a cooling medium inlet 13 connected to the balloon 1. By providing the cooling medium inlet 13 on the middle tube 11 connected to the balloon 1, it is possible to effectively ensure that cooling media such as cold saline can effectively enter the balloon 1 and exit from the cooling medium outlet 3 on the surface of the balloon 1, thereby increasing the depth of heat conduction. Furthermore, the cooling medium inlet 13 is located on the side of the middle tube 11 adjacent to the ablation electrode 2. This ensures that during the discharge of cooling media such as cold saline through the cooling medium outlet 3, there will be no insufficient pressure medium inside the balloon 1, preventing deformation and ensuring accurate locking and limiting of the balloon 1. This guarantees full contact between the ablation electrode 2 and the surface of the atrial septum puncture hole without positional misalignment.

[0066] In this embodiment, the pressure conduit 12 is used to contain a developing solution containing a mixture of cold saline and contrast agent. A marking ring 15 is also provided on the central tube 11, which is developed under X-ray to indicate the position of the ablation electrode 2. In this invention, mixing cold saline with the contrast agent effectively helps the marking ring 15 to develop under X-ray, thereby indicating the position of the ablation electrode 2.

[0067] Of course, this embodiment does not specifically limit the liquid contained in the pressure pipe 12. In other embodiments, the pressure pipe 12 is used to contain cold saline that does not contain contrast agent.

[0068] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A non-implanted atrial shunt device, characterized in that include: Radiofrequency components for non-implantable atrial shunt devices; And, catheter assembly (6), for filling the balloon (1) with a medium; Radiofrequency components for non-implantable atrial shunt devices include: The balloon (1) has an ablation working state that expands after being filled with a medium, and a normal state in which the balloon (1) is not filled with a medium. An ablation electrode (2) is disposed on the balloon (1), and the ablation electrode (2) contacts the surface of the interatrial septum puncture hole to form an interatrial septum puncture hole; a cooling medium outlet (3) is disposed on the surface of the balloon (1), and the cooling medium outlet (3) is located at the ablation position of the ablation electrode (2); The inner tube (10) and the middle tube (11) of the catheter assembly (6) form a pressure conduit (12) for injecting a medium into the balloon (1); the middle tube (11) is also provided with a cooling medium inlet (13) connected to the balloon (1); the cooling medium inlet (13) is located on the side of the middle tube (11) adjacent to the ablation electrode (2); The balloon (1) is a single balloon, which includes: a limiting part (4) that abuts against the interatrial septum in the ablation working state, and an ablation part (5) provided with the ablation electrode (2). The ablation part (5) is located at the proximal end of the limiting part (4). In the ablation working state, the diameter of the limiting part (4) is larger than the diameter of the ablation part (5). The cooling medium outlet (3) is located in the ablation part (5). The proximal end of the ablation part (5) is provided with a conical structure. Along the direction from the distal end to the proximal end, the diameter of the conical structure gradually decreases until it is attached to the outer surface of the middle tube (11).

2. The non-implanted atrial shunt device of claim 1, wherein, The pressure conduit (12) is used to contain cold saline solution; or, the pressure conduit (12) is used to contain a developing solution in which cold saline solution and contrast agent are mixed.

3. The non-implanted atrial shunt device of claim 2, wherein, The central tube (11) is also provided with a marking ring (15), which is developed under X-ray to indicate the position of the ablation electrode (2).

4. The non-implanted atrial shunt device of claim 1, wherein, In the ablation working state, the limiting part (4) is an elliptical spherical structure; and / or, In the ablation working state, the ablation part (5) is a straight cylindrical structure.

5. The non-implanted atrial shunt device of claim 4, wherein, The cooling medium outlets (3) are evenly and densely distributed on the surface of the ablation section (5) in the circumferential direction and extending along its length.

6. The non-implanted atrial shunt device of claim 1, wherein, The ablation electrode (2) includes: a plurality of electrode sheets extending along the length direction of the ablation portion (5) and distributed in the circumferential direction of the ablation portion (5); The cooling medium outlet (3) is arranged on the electrode sheet; and / or, the cooling medium outlet (3) is arranged on the ablation portion (5) between adjacent electrode sheets.

7. The non-implanted atrial shunt device of claim 6, wherein, The electrode pad includes: a working section (7) that contacts the surface of the interatrial septal puncture hole to form an interatrial septal puncture hole, an insulating section (8) extending toward the catheter assembly (6), and an extension section (9) extending into the catheter assembly (6). The cooling medium outlet (3) is evenly arranged on the working section (7).

8. The non-implanted atrial shunt device of claim 7, wherein, The electrode sheet is fixed to the surface of the ablation part (5) by means of flexible circuit printing.

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