CN216167811U - Cardiac pulse electric field ablation catheter - Google Patents
Cardiac pulse electric field ablation catheter Download PDFInfo
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- CN216167811U CN216167811U CN202122130103.8U CN202122130103U CN216167811U CN 216167811 U CN216167811 U CN 216167811U CN 202122130103 U CN202122130103 U CN 202122130103U CN 216167811 U CN216167811 U CN 216167811U
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Abstract
The utility model relates to the technical field of medical equipment, in particular to a cardiac pulse electric field ablation catheter, which comprises: a catheter body; the ablation assembly is movably arranged in the catheter body and extends along the axial direction of the catheter body, the head of the ablation assembly is provided with a plurality of ablation ridges which are distributed at intervals along the circumferential direction of the catheter body, and ablation electrodes are arranged on the outer surface of the ablation ridges; the ablation assembly is provided with a contraction state which moves towards the tail part of the catheter body so that the ablation ridges are completely retracted into the catheter body, and a working state which moves towards the head part of the catheter body so that the ablation ridges extend out of the catheter body, and when the ablation assembly is in the working state, the ablation ridges are all bent towards the direction far away from the axis of the catheter body. The length of the ablation ridges extending out of the catheter body is controlled, the ablation ridges are controlled to be unfolded to be in a working state, the ablation ridges are matched with the shape of the pulmonary vein opening, and the ablation electrodes can be well attached to myocardial tissues so as to ensure the damage degree of the myocardial tissues.
Description
Technical Field
The utility model relates to the technical field of medical equipment, in particular to a cardiac pulsed electric field ablation catheter.
Background
Atrial fibrillation is one of the most common clinical arrhythmia, has high morbidity, can induce and aggravate heart failure and also can cause thromboembolic events to cause stroke in the brain, and can cause death and disability in severe cases. Early detection and early treatment are particularly important.
The primary mode of treating arrhythmias, such as atrial fibrillation, is currently the creation of one or more lesions that must be large enough to destroy the arrhythmogenic tissue or sufficiently interfere with or isolate abnormal electrical conduction within the myocardial tissue to achieve the effect of treating the arrhythmia. The short-time high-intensity electric field can affect the phospholipid bilayer structure of the cell membrane, so that the cell membrane generates hydrophilic micropores to form channels, and other macromolecules can enter cells, thereby causing cell necrosis or apoptosis (programmed death). The pulse electric field can generate irreversible electroporation to the myocardial cells under ideal conditions to improve the arrhythmia symptoms such as atrial fibrillation. The cardiac pulsed electric field ablation catheters of the prior art are usually provided with a ring-shaped ablation structure at the distal end for the targeted ablation of myocardial tissue cells. However, the body types of different people are different, the sizes of the pulmonary vein openings of the heart are different, the annular ablation structure cannot be matched with the pulmonary vein openings of different sizes, the catheter cannot be guaranteed to completely remove the myocardial tissue after penetrating into the human body, the degree of damage to the myocardial tissue of a part of patients after the operation is small, and the treatment effect cannot be achieved.
SUMMERY OF THE UTILITY MODEL
Therefore, the technical problem to be solved by the present invention is to overcome the defect that the cardiac pulsed electric field ablation catheter in the prior art cannot adapt to pulmonary veins of different sizes, so as to provide a cardiac pulsed electric field ablation catheter.
In order to solve the above technical problem, the present invention provides a cardiac pulsed electric field ablation catheter, comprising:
a catheter body;
the ablation assembly is movably arranged in the catheter body and extends along the axial direction of the catheter body, the head of the ablation assembly is provided with a plurality of ablation ridges which are distributed at intervals along the circumferential direction of the catheter body, and ablation electrodes are arranged on the outer surface of the ablation ridges;
the ablation assembly is provided with a contraction state which moves towards the tail part of the catheter body so that the ablation ridges are completely retracted into the catheter body, and a working state which moves towards the head part of the catheter body so that the ablation ridges extend out of the catheter body, and when the ablation assembly is in the working state, the ablation ridges are all bent towards the direction far away from the axis of the catheter body.
Optionally, the ablation assembly further comprises an ablation tube, one end of the ablation tube is fixedly connected with the ablation ridge, the other end of the ablation tube is provided with an operating handle, and the ablation tube and the catheter body are coaxially arranged.
Optionally, a spine wire is connected between the ablation spine and the ablation tube, a first end cover is arranged at one end of the ablation tube, and the spine wire is fixedly connected with the first end cover.
Optionally, the ablation electrode is a plurality of individual electrodes, each of which is electrically connected to an external impulse device via an ablation lead.
Optionally, a connector is arranged on the operating handle, one end of the connector is electrically connected with the ablation lead, and the other end of the connector is electrically connected with the external pulse device.
Optionally, the ablation wire extends along the catheter body lumen.
Optionally, the operating handle is further provided with a bending adjusting piece, and a traction wire is connected between the bending adjusting piece and the catheter body.
Optionally, a second end cap is mounted on the catheter body head, and an ablation ridge is disposed through the second end cap.
Optionally, the ablation electrode is annularly sleeved on the ablation ridge.
Optionally, 4-8 ablation ridges are uniformly arranged along the circumferential direction of the catheter body.
The technical scheme of the utility model has the following advantages:
1. the utility model provides a cardiac pulsed electric field ablation catheter, which comprises: a catheter body; the ablation assembly is movably arranged in the catheter body and extends along the axial direction of the catheter body, the head of the ablation assembly is provided with a plurality of ablation ridges which are distributed at intervals along the circumferential direction of the catheter body, and ablation electrodes are arranged on the outer surface of the ablation ridges; the ablation assembly is provided with a contraction state which moves towards the tail part of the catheter body so that the ablation ridges are completely retracted into the catheter body, and a working state which moves towards the head part of the catheter body so that the ablation ridges extend out of the catheter body, and when the ablation assembly is in the working state, the ablation ridges are all bent towards the direction far away from the axis of the catheter body.
When the cardiac pulse electric field ablation catheter is used for carrying out ablation operation on cardiac muscle tissues of a human body, firstly, a puncture needle is used for perforating on the cardiac atrial septal tissues, one end of the catheter body penetrates from one side of the perforation to the other side, the ablation ridges are controlled to jointly extend from the head of the catheter body to the outside of the catheter body, after the ablation ridges are unfolded to be in a working state, the ablation ridges are moved towards the tail part of the catheter body, the ablation ridges can be better attached to the cardiac muscle tissues by controlling the length of the ablation ridges extending out of the catheter body and further controlling the size of the ablation ridges after being unfolded to be in the working state, so that the ablation ridges can be adapted to pulmonary veins of any size, and the ablation electrodes can be better attached to the cardiac muscle tissues, and the degree of injury to the cardiac muscle tissues after ablation can be ensured to achieve the treatment effect on the pulmonary veins of any size. A pulse signal is applied to the ablation electrode by an external pulse device. Through making the direction bending that melts the ridge orientation and keep away from pipe body axis for the cardiac muscle tissue of pulmonary vein department and a plurality of shape looks adaptations that melt the ridge, let melt the ridge and can laminate better on cardiac muscle tissue, make cardiac muscle tissue cell can thoroughly be eliminated, can avoid esophagus damage and phrenic nerve damage simultaneously. The application of short, high dc pulse voltages to tissue can generate high electric field strengths of hundreds to thousands of volts per centimeter. The cell membrane of the tissue exposed to this high electric field strength can produce pores, resulting in disruption of the cell membrane. Because the voltage penetration threshold of the myocardial cells is lower relative to that of other tissues (such as phrenic nerve, esophagus and blood vessel), the myocardial cells can be selectively ablated without affecting other non-target tissues by controlling the voltage amplitude range of the pulse square wave to be 300V-2000V. Meanwhile, the pulse discharge time is short, so that the heat effect cannot be generated, and the esophagus and the phrenic nerve can be prevented from being damaged.
2. The ablation component of the cardiac pulse electric field ablation catheter further comprises an ablation tube, one end of the ablation tube is fixedly connected with the ablation ridge, the other end of the ablation tube is provided with an operating handle, and the ablation tube and the catheter body are coaxially arranged. The ablation tube is driven to move in the catheter body through the operating handle, and then the ablation ridge is driven to be mutually converted between the contraction state and the working state.
3. According to the cardiac pulse electric field ablation catheter provided by the utility model, the ablation electrode is a plurality of independent electrodes, and each independent electrode is electrically connected with external pulse equipment through an ablation lead. Through carrying out the independent control to a plurality of independent electrodes, can control accurately and melt the pulse voltage value of each department on the spine, guarantee to carry out accurate ablation to the myocardial tissue around the pulmonary vein mouth, avoid haring esophagus and phrenic nerve simultaneously.
4. According to the cardiac pulse electric field ablation catheter provided by the utility model, the operation handle is also provided with the bending adjusting piece, and the traction wire is connected between the bending adjusting piece and the catheter body. The degree of tightness of the traction wire is controlled through the bending adjusting piece on the operating handle, so that the catheter body is controlled to bend, and the head of the catheter body is driven to reach a target position to melt targeted tissues.
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 schematic structural diagram of a cardiac pulsed electric field ablation catheter provided in an embodiment of the present invention.
Fig. 2 is a schematic structural view of an ablation ridge provided in an embodiment of the present invention.
Fig. 3 is a schematic view of the internal structure of a catheter body provided in an embodiment of the present invention.
Fig. 4 is a schematic working diagram of a bend-adjusting member provided in the embodiment of the present invention.
Fig. 5 is a schematic diagram of the operation of a cardiac pulsed electric field ablation catheter in accordance with an embodiment of the present invention.
Description of reference numerals: 1. a catheter body; 2. an ablation ridge; 3. a first end cap; 4. a second end cap; 5. an ablation tube; 6. ridge threads; 7. an operating handle; 8. an ablation electrode; 9. a connector; 10. a bend adjusting part; 11. the ostium of the pulmonary vein.
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 derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within 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.
In addition, 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.
Fig. 1 to 4 show a cardiac pulsed electric field ablation catheter provided in this embodiment, including: the catheter comprises a catheter body 1, an ablation assembly arranged in the catheter body 1 and an operating handle 7 arranged at the tail part of the catheter body 1.
As shown in fig. 1 to 3, the ablation assembly is movably disposed in the catheter body 1 and extends along the axial direction of the catheter body 1. The head of the ablation component is provided with a plurality of ablation ridges 2, the ablation ridges 2 are distributed along the circumferential direction of the catheter body 1 at intervals, and ablation electrodes 8 are arranged on the outer surfaces of the ablation ridges 2. The head of the catheter body 1 is provided with a second end cover 4, and the ablation ridge 2 is arranged through the second end cover 4. 4-8 ablation ridges 2 are uniformly arranged along the circumferential direction of the catheter body 1. In the present embodiment, there are 6 ablation ridges 2. The ablation ridge 2 is made of a material with high insulating properties and is to meet biocompatibility requirements and be sufficiently flexible. The ablation ridge 2 in this embodiment is made of polyamide resin. The ablation assembly further comprises an ablation tube 5, one end of the ablation tube 5 is fixedly connected with the ablation ridge 2, the other end of the ablation tube is provided with an operating handle 7, and the ablation tube 5 and the catheter body 1 are coaxially arranged. The ablation spine 2 and the ablation tube 5 are connected with spine wires 6, the ablation spine 2 is of a hollow tubular structure, the spine wires 6 extend along the inner cavity of the ablation spine 2, one end of the ablation tube 5 is provided with a first end cover 3, and the spine wires 6 are fixedly connected with the first end cover 3. The spinal wires 6 are made of shape memory alloy, and the spinal wires 6 are made of nickel titanium alloy in the embodiment.
The ablation assembly has a contraction state moving towards the tail part of the catheter body 1 to enable the ablation ridges 2 to be completely retracted into the catheter body 1, and an operation state moving towards the head part of the catheter body 1 to enable the ablation ridges 2 to extend out of the catheter body 1, and when the ablation assembly is in the operation state, the ablation ridges 2 are all bent towards the direction far away from the axis of the catheter body 1. The ablation tube 5 is driven to move in the catheter body 1 by pushing and pulling the operating handle 7, and then the ridge wire 6 and the ablation ridge 2 are driven to move. When the ablation spine 2 is in a working state, the spine wire 6 automatically bends towards the direction away from the axis of the catheter body 1 without limitation, so that the tubular ablation spine 2 is driven to bend, and the ablation spine 2 is switched from a contraction state to the working state.
The ablation electrode 8 is a plurality of independent electrodes, and the ablation electrode 8 is annularly sleeved on the ablation ridge 2. Each independent electrode is electrically connected with an external pulse device through an ablation lead. The operating handle 7 is provided with a connector 9, one end of the connector 9 is electrically connected with the ablation lead, and the other end of the connector 9 is electrically connected with external pulse equipment. In order to ensure that the ablation electrodes 8 can ensure a sufficiently large effective ablation range and simultaneously adapt to an ablation structure with a bent front end, the length of each ablation electrode 8 is at least 1.5 mm, and the ablation electrodes are made of platinum-iridium alloy materials. The electric field intensity around the ablation electrode 8 is influenced by the cross sectional area of the ablation electrode 8, the smaller the cross sectional area of the ablation electrode 8 is, the more concentrated the field intensity at the edge of the ablation electrode 8 is, the more easy the ionization phenomenon is to occur, the larger the cross sectional area of the ablation electrode 8 is, the more uniform the field intensity distribution is, but the cross sectional area of the ablation electrode 8 is simultaneously controlled by the overall structure of the ablation ridge 2 and the size of the left atrium, and the cross sectional area of the ablation electrode 8 is controlled to be 0.25-2 square millimeters in comprehensive consideration. The cross-sectional area of the ablation electrode 8 in this embodiment is 1 square millimeter.
A plurality of ablation leads extend from the inner cavity of the ablation ridge 2 into the inner cavity of the catheter body 1 and along the inner cavity of the catheter body 1 to be connected with the connector 9. The operating handle 7 is also provided with a bending adjusting piece 10, and a traction wire is connected between the bending adjusting piece 10 and the catheter body 1. As shown in fig. 4, the degree of tightness of the traction wire is controlled by rotating the bending adjusting piece 10 on the operating handle 7, so as to control the bending of the catheter body 1, and thus the head of the catheter body 1 is driven to reach a target position to ablate the target tissue.
When a cardiac pulse electric field ablation catheter is used for carrying out a pulmonary vein isolation operation at a pulmonary vein opening 11 of a human body, firstly, a puncture needle is used for puncturing atrial septal tissue to form a perforation, the head of the catheter body 1 extends into the left atrium from the perforation, then, the operating handle 7 is pushed, and the plurality of ablation ridges 2 are controlled to extend out of the catheter body 1 from the head of the catheter body 1. By controlling the length of the ablation ridge 2 extending out of the catheter body 1, the volume of the ablation ridge 2 after being unfolded can be changed, so that the catheter can be suitable for pulmonary vein orifices with different sizes. After the ablation ridge 2 is unfolded to be in a working state, the ablation ridge 2 is moved towards the tail part of the catheter body 1, the ablation ridge 2 is completely contacted with the pulmonary vein opening, the ablation electrode 8 is attached to the outer side of the pulmonary vein opening for ablation, and the injury degree of myocardial tissues after ablation can be guaranteed to reach a treatment effect on pulmonary veins of any size. In order to avoid arrhythmia caused by stimulation of the heart by the high-voltage pulse, the high-voltage pulse energy is released in the absolute refractory period of the myocardium, one pulse group comprises a plurality of pulse groups, each pulse group comprises a plurality of bidirectional pulses, the voltage amplitude is 300-2000V, signals of a sensing Electrogram (EGM) are immediately collected through electrodes to determine the ablation effect, and whether the steps are repeated for re-ablation is judged until the EGM signals show that the pulmonary veins are completely isolated. The ablation electrode 8 is pulsed by an external pulsing device. By bending the ablation ridge 2 towards the direction far away from the axis of the catheter body 1, the ablation electrode 8 on the ablation ridge 2 can be well attached to the myocardial tissue, so that the myocardial tissue cells of the pulmonary vein orifice 11 near the ablation electrode 8 can be completely eliminated. The application of short, high dc pulse voltages to tissue can generate high electric field strengths of hundreds to thousands of volts per centimeter. The cell membrane of the tissue exposed to this high electric field strength can produce pores, resulting in disruption of the cell membrane. Because the voltage penetration threshold of the myocardial cells is lower relative to that of other tissues (such as phrenic nerve, esophagus and blood vessel), the myocardial cells can be selectively ablated without affecting other non-target tissues by controlling the voltage amplitude range of the pulse square wave to be 300V-2000V. Meanwhile, the pulse discharge time is short, so that the heat effect cannot be generated, and the esophagus and the phrenic nerve can be prevented from being damaged.
Adopt dirty pulse electric field ablation catheter to carry out pulmonary vein isolation operation, it will be short-term to ablate electrode 8 on the ridge 2 through the crooked ablation of catheter body 1 head, thereby high-voltage pulse applies to target tissue and produces local high voltage electric field, the cell membrane can form one kind and regard as microporous hydrophilicity passageway under the effect of this electric field, when the threshold value that electric field intensity is higher than the cell membrane and pulse width and pulse quantity are big enough, can produce irreversible electroporation phenomenon, the passageway can't be closed, it gets into the cell to be difficult to pass the cell membrane at this moment and get into this passageway of the inside macromolecule accessible of cell, thereby make the cell produce and die. The threshold value of different tissue cells for voltage penetration is different, and the pulsed electric field technology can selectively kill the myocardial cells (the threshold value is about 400V/cm) without affecting non-target tissues such as esophagus, nerves, blood vessels and the like. Because the pulse release time is short (microsecond level), the thermal effect can not be generated, thereby avoiding the problems of pulmonary vein stenosis, esophageal injury and the like. And the safety of high-voltage pulse ablation is ensured, the shapes of the ablation ridges 2 which are bent towards the direction far away from the axis of the catheter body 1 are suitable for pulmonary vein port structures with different sizes, and ablation can be carried out quickly and effectively.
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 utility model.
Claims (10)
1. A cardiac pulsed electric field ablation catheter, comprising:
a catheter body (1);
the ablation assembly is movably arranged in the catheter body (1) and extends along the axial direction of the catheter body (1), the head of the ablation assembly is provided with a plurality of ablation ridges (2), the ablation ridges (2) are distributed at intervals along the circumferential direction of the catheter body (1), and ablation electrodes (8) are arranged on the outer surface of the ablation ridges (2);
the ablation assembly is provided with a contraction state which moves towards the tail of the catheter body (1) to enable the ablation ridges (2) to be completely retracted into the catheter body (1), and an operation state which moves towards the head of the catheter body (1) to enable the ablation ridges (2) to extend out of the catheter body (1), and when the ablation assembly is in the operation state, the ablation ridges (2) are bent towards the direction far away from the axis of the catheter body (1).
2. The cardiac pulsed electric field ablation catheter as claimed in claim 1, wherein the ablation assembly further comprises an ablation tube (5), one end of the ablation tube (5) is fixedly connected with the ablation ridge (2), the other end is provided with an operating handle (7), and the ablation tube (5) is coaxially arranged with the catheter body (1).
3. The cardiac pulsed electric field ablation catheter as claimed in claim 2, wherein a spine wire (6) is connected between the ablation spine (2) and the ablation tube (5), a first end cap (3) is arranged at one end of the ablation tube (5), and the spine wire (6) is fixedly connected with the first end cap (3).
4. A cardiac pulsed electric field ablation catheter according to claim 2 or 3, wherein the ablation electrode (8) is a plurality of individual electrodes, each of which is electrically connected to an external pulsing device by an ablation lead.
5. A cardiac pulsed electric field ablation catheter according to claim 4, wherein a connector (9) is provided on the operating handle (7), one end of the connector (9) being electrically connected to the ablation wire and the other end being electrically connected to an external pulse device.
6. The cardiac pulsed electric field ablation catheter according to claim 4, wherein the ablation wire extends along the catheter body (1) lumen.
7. The cardiac pulsed electric field ablation catheter according to claim 2 or 3, wherein the operating handle (7) is further provided with a bending adjusting piece (10), and a traction wire is connected between the bending adjusting piece (10) and the catheter body (1).
8. A cardiac pulsed electric field ablation catheter according to any of claims 1 to 3, wherein a second end cap (4) is mounted on the head of the catheter body (1), and the ablation ridge (2) is disposed through the second end cap (4).
9. The cardiac pulsed electric field ablation catheter according to any of claims 1 to 3, wherein the ablation electrode (8) is annularly sleeved on the ablation ridge (2).
10. The cardiac pulsed electric field ablation catheter according to any one of claims 1 to 3, wherein 4 to 8 ablation ridges (2) are uniformly arranged along the circumferential direction of the catheter body (1).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202122130103.8U CN216167811U (en) | 2021-09-03 | 2021-09-03 | Cardiac pulse electric field ablation catheter |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202122130103.8U CN216167811U (en) | 2021-09-03 | 2021-09-03 | Cardiac pulse electric field ablation catheter |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117694997A (en) * | 2024-02-05 | 2024-03-15 | 成都飞云科技有限公司 | Ablation catheter, ablation handle and ablation assembly |
| US12076071B2 (en) | 2020-08-14 | 2024-09-03 | Kardium Inc. | Systems and methods for treating tissue with pulsed field ablation |
-
2021
- 2021-09-03 CN CN202122130103.8U patent/CN216167811U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US12076071B2 (en) | 2020-08-14 | 2024-09-03 | Kardium Inc. | Systems and methods for treating tissue with pulsed field ablation |
| CN117694997A (en) * | 2024-02-05 | 2024-03-15 | 成都飞云科技有限公司 | Ablation catheter, ablation handle and ablation assembly |
| CN117694997B (en) * | 2024-02-05 | 2024-04-26 | 成都飞云科技有限公司 | Ablation catheter, ablation handle and ablation assembly |
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