CN115590603A - Radio frequency assembly of non-implantation atrium shunt device and non-implantation atrium shunt device - Google Patents

Radio frequency assembly of non-implantation atrium shunt device and non-implantation atrium shunt device Download PDF

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CN115590603A
CN115590603A CN202110781897.6A CN202110781897A CN115590603A CN 115590603 A CN115590603 A CN 115590603A CN 202110781897 A CN202110781897 A CN 202110781897A CN 115590603 A CN115590603 A CN 115590603A
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ablation
shunt device
electrode
cooling medium
balloon
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贺涛
丁毅寿
张昱昕
蒲忠杰
张喜博
李向义
王磊
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Shanghai Shape Memory Alloy Material Co Ltd
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Shanghai Shape Memory Alloy Material Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595—Cauterization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00714—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

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Abstract

The invention relates to the technical field of medical equipment, in particular to a radio frequency assembly for a non-implanted atrium shunt device and the non-implanted atrium shunt device, and the radio frequency assembly for the non-implanted atrium shunt device comprises: the balloon has an ablation working state of expanding after being flushed with a medium and a normal state of not filling the medium in the balloon; the ablation electrode is arranged on the balloon and is in contact with the surface of the atrial septal puncture hole to form an atrial septal pore; the surface of the balloon is provided with a cooling medium outlet, and the cooling medium outlet is positioned at the ablation position of the ablation electrode.

Description

Radio frequency assembly of non-implantation atrium shunt device and non-implantation atrium shunt device
Technical Field
The invention 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.
Background
Heart failure is a potentially fatal disease common to humans, and despite the best efforts of hospitals to treat it, healing is often difficult to control clinically. In particular "ejection fraction retention heart failure (HFpEF)" the prevalence of this disease has increased significantly over the years, but its treatment remains a challenge to the clinician.
The existing treatment mode is to puncture at the interatrial septum of the heart, artificially create a hole, drain the blood pressure in the left atrium to the right atrium, and achieve the purpose of reducing the high pressure in the left atrium, thereby effectively improving the 'ejection fraction retention heart failure'.
During atrial septal puncture procedures, non-implanted atrial shunt devices are required. The non-implanted atrial shunt device has the requirement of extending the thermal ablation range to a deeper level of the tissue during the radiofrequency ablation process, thereby achieving the effect of delaying tissue healing. However, the existing non-implanted atrial shunt device cannot effectively achieve the deeper extension of the thermal ablation range to the tissue, and is difficult to meet the requirement of the non-implanted atrial shunt device on delaying the healing of the tissue.
Disclosure of Invention
The invention aims to solve the technical problem that in the prior art, the radio frequency assembly for the non-implanted atrial shunt device has poor capability of expanding the thermal ablation range to the deeper level of tissues and cannot meet the requirement of medical workers on delaying the healing of the tissues in the radio frequency ablation process, and in order to solve the problem, the invention provides the radio frequency assembly for the non-implanted atrial shunt device, which comprises the following components:
the balloon has an ablation working state of being expanded after the medium is flushed in and a normal state of not being filled with the medium in the balloon;
the ablation electrode is arranged on the balloon and is in contact with the surface of the atrial septal puncture hole to form an atrial septal pore; the surface of the balloon is provided with a cooling medium outlet, and the cooling medium outlet is positioned at the ablation position of the ablation electrode.
Optionally, the balloon comprises: the limiting part is abutted against the atrial septum in the ablation working state, and the ablation part is provided with the ablation electrode and is arranged on one side, close to the catheter component, of the limiting part; in the ablation working state, the diameter of the limiting part is larger than that of the ablation part;
the cooling medium outlet is arranged at the ablation part.
Optionally, in the ablation working state, the limiting part is of an elliptical sphere structure; and/or the presence of a gas in the gas,
in the ablation working state, the ablation part is of a straight cylindrical structure.
Optionally, the cooling medium outlets are uniformly and densely distributed in the circumferential direction of the surface of the ablation part and along the length direction of the ablation part.
Optionally, the ablation electrode comprises: the electrode plates extend along the length direction of the ablation part and are distributed in the circumferential direction of the ablation part;
the cooling medium outlet is arranged on the electrode plate; and/or the cooling medium outlet is arranged on the ablation part between the adjacent electrode plates.
Optionally, the electrode sheet includes: a working section in contact with the surface of the atrial septal puncture to form an atrial septal puncture, an insulating section extending toward the catheter assembly, and an extending section extending into the catheter assembly;
the cooling medium outlets are uniformly arranged on the working section.
Optionally, the electrode plate is fixed on the surface of the ablation part in a flexible circuit printing mode.
A non-implantable atrial shunt device comprising:
a radio frequency assembly for a non-implanted atrial shunt device; and (c) a second step of,
a catheter assembly for inflating a medium into the balloon.
Optionally, the inner tube and the middle tube of the catheter assembly enclose a pressure conduit for injecting a medium into the balloon;
the middle pipe is also provided with a cooling medium perfusion opening communicated with the saccule.
Optionally, the cooling medium perfusion opening is arranged at one side of the middle pipe adjacent to the ablation electrode.
Optionally, the pressure pipeline is used for containing cold brine; or the pressure pipeline is used for containing the developing solution mixed by cold saline and the contrast agent.
Optionally, a marker ring is further disposed on the middle tube, and the marker ring is developed under X-ray to indicate the position of the ablation electrode.
The technical scheme of the invention has the following advantages:
1. the invention provides a radio frequency assembly for a non-implanted atrial shunt device, comprising: the balloon has an ablation working state of expanding after being flushed with a medium and a normal state of not filling the medium in the balloon; the ablation electrode is arranged on the balloon and is in contact with the surface of the atrial septal puncture hole to form an atrial septal pore; the surface of the balloon is provided with a cooling medium outlet, and the cooling medium outlet is positioned at the ablation position of the ablation electrode.
In the invention, the cooling medium outlet is arranged on the surface of the balloon, and the cooling medium outlet can effectively spray cooling medium such as cold saline water to the ablation position of the ablation electrode. Because the electrode temperature may indirectly reflect whether the tissue temperature is sufficient to denature proteins and subsequently 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 result, requiring a reduction in energy output. The cold saline and other cooling media sprayed from the cooling medium outlet can actively wash the ablation electrode with physiological saline and other media in the ablation process, so that the temperature of the electrode at the head end is reduced. The temperature of the ablation electrode can be reduced by the cooling medium such as the cold saline water, so that the problem that the local temperature of the ablation electrode is too high and blood scabs is avoided, the ablation electrode can work more durably, and the depth of heat conduction is increased.
2. The radiofrequency component for the non-implanted atrial shunt device is provided with the cooling medium outlets which are uniformly and densely distributed in the circumferential direction of the surface of the ablation part and along the length direction of the ablation part.
Above-mentioned even densely distributed coolant outlet can be towards the coolant such as the cold salt solution of ablation portion surface blowout effectively to evenly reduce the temperature of melting electrode tip end electrode effectively, thereby avoid melting the electrode and appear local high temperature and avoid the problem that blood scabbed, consequently make the work that melts the electrode and can be more lasting, increase heat-conducting degree of depth.
3. The invention provides a radio frequency assembly for a non-implanted atrial shunt device, the ablation electrode comprising: the electrode plates extend along the length direction of the ablation part and are distributed in the circumferential direction of the ablation part; the cooling medium outlet is arranged on the electrode sheet; and/or the cooling medium outlet is arranged on the ablation part between the adjacent electrode plates.
According to the invention, the electrode plate of the radio frequency assembly is split, so that when the atrial septum assembly is punctured and subjected to radio frequency reaming, atrial septum tissues around the puncture hole are damaged in different regions, and when the atrial septum assembly is damaged while the balloon is expanded, the puncture hole can extend along the circumferential direction of the hole, so that the radial tearing of the puncture hole can be effectively weakened, the forming quality of the puncture hole is improved, and the later recovery of a patient is facilitated. In addition, because the annular pole piece cover among the prior art establishes outside spacing sacculus, when the sacculus pressurized and propped up and when row pressed the shrink, the volume change speed of sacculus was very fast, because the hardness of pole piece is far higher than the sacculus, lead to the pole piece when following sacculus shrink and expansion, because the too big crack that can lead to appearing on the pole piece of stress, lead to the pole piece to the inhomogeneous problem of melting of interatrial tissue. In the invention, by arranging the electrode plates into a plurality of pieces, the possibility of damage of the electrode plates can be reduced even if stress is applied when the saccule is propped up or contracted, thereby prolonging the service life of the electrode plates. More importantly, in the invention, the cooling medium outlet is arranged on the electrode plate and the ablation part between the adjacent electrode plates, so that the cooling medium such as cold brine and the like can be further uniformly sprayed, and all parts of the ablation part can be effectively cooled.
4. According to the radio frequency assembly for the non-implanted atrial shunt device, the electrode plate is fixed on the surface of the ablation part in a flexible circuit printing mode.
According to the invention, the electrode plate and other conductive materials are printed on the surface of the balloon by using a flexible circuit printing technology, the thickness and flexibility of the electrode plate of the balloon formed by the process method can be greatly improved, so that the shrinkage size of the catheter can be reduced, the diameter size of the catheter can be further reduced, and the surgical wound can be reduced. Meanwhile, the flexible circuit printing can draw abundant and various electrode shapes, so that the flexible circuit printing can be better matched with operation requirements.
5. The invention is used for the non-implantation atrium shunt device, the inner tube and the middle tube of the catheter component enclose a pressure pipeline for injecting media into the saccule; the middle pipe is also provided with a cooling medium perfusion opening communicated with the saccule.
Through set up the coolant filling mouth that is linked together with the sacculus on well pipe, can guarantee effectively that coolant such as cold brine can get into in the sacculus effectively to from the coolant export discharge on sacculus surface, thereby realize the effect that increases heat-conducting degree of depth.
6. According to the non-implanted atrial shunt device, the cooling medium perfusion opening is formed in one side, adjacent to the ablation electrode, of the middle tube.
Through filling the cooling medium into one side that the mouth set up adjacent ablation electrode, can guarantee that cooling medium such as cold brine is in the in-process of exporting the exhaust through the cooling medium, thereby can not appear in the sacculus that pressure medium is not enough to lead to this sacculus to take place deformation and make the sacculus can't realize joint limit function's problem accurately, guarantee to melt electrode and room interval puncture hole's surface abundant contact and can not take place the position offset.
7. The pressure pipeline is used for containing cold saline; or the pressure pipeline is used for containing the developing solution mixed by the cold saline and the contrast agent. The middle tube is further provided with a marking ring, and the marking ring is developed under X-rays to indicate the position of the ablation electrode.
The marker ring is effectively assisted in the present invention by mixing cold saline with a contrast agent to visualize the marker ring under X-rays, thereby indicating the position of the ablation electrode.
8. The invention provides a device for non-implantation atrial shunt, the balloon comprises: the limiting part is abutted against the atrial septum in the ablation working state, and the ablation part is provided with the ablation electrode and is arranged on one side, close to the catheter component, of the limiting part; in the ablation working state, the diameter of the limiting part is larger than that of the ablation part; the cooling medium outlet is arranged at the ablation part.
In the present invention, the method of operating a non-implanted atrial shunt by medical practitioners is altered by placing the ablation electrode on the side of the balloon adjacent the catheter assembly. In the operation process, a medical worker drives the balloon to extend into the left atrium, so that the balloon is fed into one side of the left atrium for a certain distance, and the extending distance exceeds the contact position of the ablation electrode and the atrial septal puncture hole. The medical practitioner then fills the balloon with a medium to bring it to an inflated state. After the sacculus is in the inflation state, medical staff pulls back the sacculus, and the sacculus contacts with the outline edge of interatrial puncture hole this moment, and medical staff's limbs can experience the resistance, and this moment shows that the sacculus reaches the spacing position, melts electrode and interatrial puncture hole's surface contact. In this state, the ablation electrode is in contact with the surface of the atrial septal puncture, and the ablation electrode reaches the designated position. Through will melting electrode setting in the sacculus be close to catheter subassembly one side, both can realize letting medical staff confirm through feeling whether the joint of sacculus targets in place, guarantee that the accurate card of sacculus is on interatrial septum tissue, and then make and melt electrode and interatrial septum puncture hole's surface position accurate relative contact, can guarantee effectively that melting electrode accurately melts interatrial puncture hole surface, can not cause the damage to other positions.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a perspective view of a radio frequency assembly for a non-implanted atrial shunt according to the present invention;
FIG. 2 is a schematic view of the position of the cooling medium outlet provided on the balloon according to the present invention;
FIG. 3 is a schematic view of the connection structure among the balloon, the ablation electrode and the catheter assembly provided by the present invention;
fig. 4 is a schematic structural diagram of the working section, the insulating section and the extending section which form the electrode sheet provided by the invention.
FIG. 5 is a schematic view of a non-implanted atrial shunt device in accordance with the present invention in use.
Description of reference numerals:
1-a balloon; 2-an ablation electrode; 3-outlet of cooling medium; 4-a limiting part; 5-an ablation part; 6-a catheter assembly; 7-a working section; 8-an insulating section; 9-an extension; 10-an inner tube; 11-middle tube; 12-a pressure line; 13-a cooling medium pouring opening; 14-sheath canal; 15-marker loop.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Furthermore, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
Example 1
The radio frequency assembly for a non-implanted atrial shunt device in this embodiment, as shown in fig. 1 and 2, includes:
the balloon 1 has an ablation working state of expanding after being flushed with a medium and a normal state of not filling the medium into the balloon 1; as shown in fig. 1, the balloon 1 includes: the limiting part 4 is abutted against the atrial septum in the ablation working state, and the ablation part 5 is provided with the ablation electrode 2, and the ablation part 5 is arranged on one side, close to the catheter component 6, of the limiting part 4; in the ablation working state, the diameter of the limiting part 4 is larger than that of the ablation part 5; the cooling medium outlet 3 is arranged at the ablation part 5; in this embodiment, in the ablation working state, the limiting part 4 is an elliptical sphere structure; in the ablation working state, the ablation part 5 is of a straight cylindrical structure;
the ablation electrode 2 is arranged on the balloon 1, and the ablation electrode 2 is in contact with the surface of the atrial septal puncture hole to form an atrial septal pore; the surface of the balloon 1 is provided with a cooling medium outlet 3, and the cooling medium outlet 3 is positioned at the ablation position of the ablation electrode 2. In the present invention, by providing the cooling medium outlet 3 on the surface of the balloon 1, the cooling medium outlet 3 can effectively eject a cooling medium such as cold saline to the ablation site of the ablation electrode 2. Because the electrode temperature may indirectly reflect whether the tissue temperature is sufficient to denature proteins and subsequently 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 water sprayed from the cooling medium outlet 3 can actively wash the ablation electrode 2 with the medium such as physiological saline water in the ablation process, so that the temperature of the electrode at the head end is reduced. The cooling medium such as the cold saline water can reduce the temperature of the ablation electrode 2 and avoid the problem that the local temperature of the ablation electrode 2 is too high so as to avoid blood scabbing, so that the ablation electrode 2 can work more durably and the depth of heat conduction is increased; the cooling medium outlets 3 are uniformly and densely distributed on the surface of the ablation part 5 in the circumferential direction and extend along the length direction of the ablation part, and the ablation electrode 2 comprises: a plurality of electrode sheets extending along the longitudinal direction of the ablation part 5 and distributed in the circumferential direction of the ablation part 5; the cooling medium outlet 3 is arranged on the electrode sheet; and the cooling medium outlet 3 is arranged on the ablation portion 5 between the adjacent electrode sheets. In the invention, the cooling medium outlet 3 is arranged on the electrode plate and the ablation part 5 between the adjacent electrode plates, so that the uniform spraying of cooling media such as cold brine and the like can be further ensured, and all parts of the ablation part 5 can be effectively cooled; the electrode plate is fixed on the surface of the ablation part 5 in a flexible circuit printing mode.
In the present embodiment, as shown in fig. 3 and 4, the electrode sheet includes: a working section 7 which contacts the surface of the atrial septal puncture to form an atrial septal puncture, an insulating section 8 which extends towards the catheter assembly 6, and an extension section 9 which extends into the catheter assembly 6; the coolant outlets 3 are arranged uniformly on the working section 7.
Of course, the cooling medium is not limited in this embodiment, and in other embodiments, the cooling medium may also be cooling gas or other liquid medium.
Of course, the present embodiment does not specifically limit the position of the cooling medium outlet 3, and in other embodiments, the cooling medium outlet 3 is disposed obliquely toward the ablation portion 5.
Example 2
A non-implantable atrial shunt device, as shown in fig. 5, comprising:
a radio frequency component;
a catheter assembly 6 for inflating the balloon 1 with a medium. As shown in fig. 1, the inner tube 10 and the middle tube 11 of the catheter assembly 6 enclose a pressure conduit 12 for injecting a medium into the balloon 1; the middle pipe 11 is also provided with a cooling medium perfusion opening 13 communicated with the saccule 1; through set up the coolant perfusion mouth 13 that is linked together with sacculus 1 on well pipe 11, can guarantee effectively that coolant such as cold salt water can get into in the sacculus 1 effectively to from the coolant export 3 discharge on sacculus 1 surface, thereby realize the effect of the degree of depth of increasing heat-conduction. And, the cooling medium perfusion opening 13 is arranged at one side of the middle tube 11 adjacent to the ablation electrode 2, so that the problem that the balloon 1 cannot be clamped and limited due to deformation of the balloon 1 caused by insufficient pressure medium in the balloon 1 in the process of discharging the cooling medium such as cold brine through the cooling medium outlet 3 can be solved, and the ablation electrode 2 is ensured to be fully contacted with the surface of the atrial septal puncture hole and not to be biased.
In this embodiment, the pressure line 12 is used to contain a contrast solution in which cold saline is mixed with contrast. The middle tube 11 is also provided with a marking ring 15, and the marking ring 15 is developed under X-ray to indicate the position of the ablation electrode 2. The marker ring 15 is effectively assisted in the present invention by the mixing of cold saline with a contrast agent to visualize under X-rays and thereby indicate the position of the ablation electrode 2.
Of course, the present embodiment does not specifically limit the liquid that the pressure pipe 12 contains, and in other embodiments, the pressure pipe 12 is used for containing cold saline without contrast medium.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (12)

1. A radio frequency assembly for a non-implantable atrial shunt device, comprising:
the balloon (1) has an ablation working state expanded after being flushed with a medium and a normal state in which the medium is not filled in the balloon (1);
the ablation electrode (2) is arranged on the balloon (1), and the ablation electrode (2) is in contact with the surface of the atrial septal puncture hole to form an atrial septal pore; the surface of the balloon (1) is provided with a cooling medium outlet (3), and the cooling medium outlet (3) is positioned at the ablation position of the ablation electrode (2).
2. The radiofrequency assembly for a non-implanted atrial shunt device of claim 1, wherein the balloon (1) comprises: the limiting part (4) is abutted against the atrial septum in the ablation working state, the ablation part (5) provided with the ablation electrode (2) is arranged, and the ablation part (5) is arranged on one side, close to the catheter component (6), of the limiting part (4); in the ablation working state, the diameter of the limiting part (4) is larger than that of the ablation part (5);
the cooling medium outlet (3) is arranged at the ablation part (5).
3. The radio frequency assembly for a non-implanted atrial shunt device according to claim 2, wherein in the ablation operating state, the limiting portion (4) is an oval sphere structure; and/or the presence of a gas in the gas,
in the ablation working state, the ablation part (5) is of a straight cylindrical structure.
4. A radiofrequency assembly for a non-implanted atrial shunt device according to claim 3, wherein the cooling medium outlets (3) are evenly densely distributed in the circumferential direction of the surface of the ablation portion (5) and extending along the length thereof.
5. The radio frequency assembly for a non-implanted atrial shunt device according to claim 2, wherein the ablation electrode (2) comprises: a plurality of electrode plates extending along the length direction of the ablation part (5) and distributed on the circumferential direction of the ablation part (5);
the cooling medium outlet (3) is arranged on the electrode sheet; and/or the cooling medium outlet (3) is arranged on the ablation part (5) between the adjacent electrode plates.
6. The radio frequency assembly for a non-implanted atrial shunt device of claim 5, wherein the electrode pads comprise: a working section (7) in contact with the surface of the atrial septal puncture to form an atrial septal puncture, an insulating section (8) extending towards the catheter assembly (6), and an extending section (9) extending into the catheter assembly (6);
the cooling medium outlets (3) are arranged uniformly on the working section (7).
7. The radio frequency assembly for a non-implanted atrial shunt device according to claim 6, wherein the electrode pads are fixed on the surface of the ablation portion (5) by means of flexible circuit printing.
8. A non-implantable atrial shunt device comprising:
the radio frequency assembly of any one of claims 1 to 7 for a non-implanted atrial shunt device; and the number of the first and second groups,
a catheter assembly (6) for inflating the balloon (1) with a medium.
9. The non-implantable atrial shunt device of claim 8,
the inner pipe (10) and the middle pipe (11) of the catheter component (6) enclose a pressure pipeline (12) for injecting media into the saccule (1);
the middle pipe (11) is also provided with a cooling medium perfusion opening (13) communicated with the saccule (1).
10. The non-implantable atrial shunt device according to claim 9, wherein the cooling medium infusion port (13) is provided at a side of the middle tube (11) adjacent to the ablation electrode (2).
11. The non-implantable atrial shunt device according to claim 9, wherein the pressure conduit (12) is for containing cold saline; or, the pressure conduit (12) is used to contain a contrast fluid mixed with cold saline.
12. The non-implantable atrial shunt device according to claim 11, wherein a marker ring (15) is further disposed on the middle tube (11), the marker ring (15) being visualized under X-rays to indicate the position of the ablation electrode (2).
CN202110781897.6A 2021-07-09 2021-07-09 Radio frequency assembly of non-implantation atrium shunt device and non-implantation atrium shunt device Pending CN115590603A (en)

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