CN213075899U - Cardiac pulse electric field ablation balloon catheter - Google Patents

Cardiac pulse electric field ablation balloon catheter Download PDF

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Publication number
CN213075899U
CN213075899U CN202021279130.0U CN202021279130U CN213075899U CN 213075899 U CN213075899 U CN 213075899U CN 202021279130 U CN202021279130 U CN 202021279130U CN 213075899 U CN213075899 U CN 213075899U
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China
Prior art keywords
catheter
balloon
electrode
rod
outer balloon
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CN202021279130.0U
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李梦梦
龙德勇
桑才华
蒋晨曦
洪光
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Beijing Anzhen Hospital
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龙德勇
李梦梦
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Abstract

The utility model discloses a cardiac pulse electric field ablation balloon catheter. Wherein, this pipe includes: the catheter comprises a catheter rod, an outer balloon, an inner balloon, a fixing rod, at least one ablation electrode and at least one mapping electrode; the inner balloon is positioned inside the outer balloon, the fixing rod penetrates through the inner balloon and the outer balloon, one end of the fixing rod is connected with the tail end of the catheter rod, the fixing rod is communicated with the catheter rod, the outer balloon and the inner balloon, at least one ablation electrode and at least one mapping electrode are arranged on the surface of the outer balloon, and electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with a circuit channel of the catheter rod. The utility model provides a based on the mode that pulsed electric field melts among the prior art and local myocardium contact surface limited and can't present the technical problem of the inside electric potential of pulmonary vein.

Description

Cardiac pulse electric field ablation balloon catheter
Technical Field
The utility model relates to the field of medical equipment, particularly, relate to a cardiac pulse electric field melts sacculus pipe.
Background
Atrial fibrillation (atrial fibrillation) is the most common type of arrhythmia in clinic, catheter ablation is the most important radical treatment means, the main target of the technology is the bilateral pulmonary vein vestibules in the left atrium, and after circular ablation is carried out on the part, the electrical activity isolation of the double pulmonary veins can be achieved, and the generation and maintenance mechanism of atrial fibrillation can be eliminated.
Traditional ablation energy comprises radio frequency ablation and cryoablation energy, but both the two types of ablation energy damage tissues through temperature effect, so that the ablation on myocardial tissues lacks selectivity, and certain damage can be caused to adjacent tissues such as phrenic nerve, esophagus and the like during ablation. There is also a risk of heart rupture, cardiac tamponade due to excessive ablation. In addition, scar is generated when local myocardium is ablated by the energy, and if scar contracture is generated at an inappropriate later stage of an ablation position, complications such as pulmonary vein stenosis and the like can be caused.
The pulse electric field ablation is novel cardiac ablation energy at present, irreversible damage is caused to myocardial cells through an applied high-voltage electric field, cell necrosis and apoptosis are caused, extracellular matrixes, peripheral blood vessels and nerves are hardly affected, cytoskeleton is completely preserved, and the risk of complications of a traditional ablation mode is avoided. However, most of the existing multi-stage catheters based on pulsed electric field ablation are basket-shaped or annular, the contact surface with local myocardium is limited, and then part of catheters are formed by modifying the traditional radio frequency/cryoablation catheters, so that the catheters cannot be used with a three-dimensional mapping system, or the catheters have no mapping electrode at the far end, and cannot present the internal potential of the pulmonary vein in real time.
Aiming at the problems that the contact surface between the pulse electric field ablation-based mode and local myocardium is limited and the internal potential of the pulmonary vein cannot be presented in the prior art, an effective solution is not provided at present.
SUMMERY OF THE UTILITY MODEL
The embodiment of the utility model provides a cardiac pulse electric field melts sacculus pipe to at least, solve among the prior art based on the mode that pulsed electric field melts and local myocardium contact surface limited and can't present the technical problem of the inside electric potential of pulmonary vein.
According to an aspect of the embodiments of the present invention, there is provided a cardiac pulsed electric field ablation balloon catheter, including: the catheter comprises a catheter rod, an outer balloon, an inner balloon, a fixing rod, at least one ablation electrode and at least one mapping electrode; the inner balloon is positioned inside the outer balloon, the fixing rod penetrates through the inner balloon and the outer balloon, one end of the fixing rod is connected with the tail end of the catheter rod, the fixing rod is communicated with the catheter rod, the outer balloon and the inner balloon, at least one ablation electrode and at least one mapping electrode are arranged on the surface of the outer balloon, and electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with a circuit channel of the catheter rod.
Further, outer sacculus is bilayer structure, including outer sacculus of outer layer and the outer sacculus of inlayer, forms the intermediate level between outer sacculus of outer layer and the outer sacculus of inlayer.
Furthermore, the middle layer is in negative pressure vacuum, and the electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with the circuit channel of the catheter rod through the middle layer.
Furthermore, a first channel communicated with the catheter rod is arranged on the fixing rod along the axis direction, a second channel communicated with the middle layer, a third channel communicated with the cavity between the outer balloon and the inner balloon and a fourth channel communicated with the inner balloon are arranged on the side surface of the fixing rod, and the second channel, the third channel and the fourth channel are sequentially arranged along the direction far away from the tail end of the catheter rod.
Furthermore, the catheter rod and the fixing rod are coaxial, at least one ablation electrode is uniformly arranged along the outer surface of the maximum diameter of the outer balloon, and the maximum diameter of the outer balloon is perpendicular to the catheter rod.
Further, the catheter shaft and the fixing rod are coaxial, at least one mapping electrode is uniformly arranged in at least one circle along the outer surface of the outer balloon, and the surface formed by each circle is perpendicular to the catheter shaft.
Further, the at least one ablation electrode and the at least one mapping electrode are arranged in parallel with each other, and the at least one mapping electrode is arranged on the distal end side of the at least one ablation electrode away from the catheter shaft.
Furthermore, the ablation electrode is of a rectangular structure and is made of iridium platinum; the marking electrode is of a rectangular structure and is made of iridium platinum.
Furthermore, the outer balloon and the inner balloon are both made of flexible medical polymer composite materials and can deform when gas or liquid is injected.
Further, in the swelling state, the outer balloon and the inner balloon are both in an ellipsoid structure.
The embodiment of the utility model provides an in, through interior sacculus and outer sacculus, can provide certain holding power, be favorable to melting pasting of electrode, improve and melt efficiency, through set up the mark survey electrode on outer sacculus, need not additionally to use mark survey electrode to carry out the monitoring of pulmonary vein electric potential activity, can detect the electrophysiological activity in the pulmonary vein when melting, the cost has been practiced thrift to a certain extent, and then solved among the prior art based on the mode that the pulse electric field melts and local myocardium contact surface limited and can't present the technical problem of the inside electric potential of pulmonary vein.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the invention without undue limitation to the invention. In the drawings:
fig. 1 is a schematic view of a cardiac pulsed electric field ablation balloon catheter according to an embodiment of the present invention;
fig. 2 is a schematic view of an alternative cardiac pulsed electric field ablation balloon catheter in accordance with an embodiment of the present invention; and
fig. 3 is a schematic view of an alternative cardiac pulsed electric field ablation balloon catheter in accordance with an embodiment of the present invention.
Detailed Description
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the accompanying drawings in conjunction with embodiments.
In order to make the technical solution of the present invention better understood, the technical solution of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts shall belong to the protection scope of the present invention.
Example 1
According to the embodiment of the utility model, a product embodiment of cardiac pulse electric field ablation balloon catheter is provided, fig. 1 is according to the utility model discloses a cardiac pulse electric field ablation balloon catheter, as shown in fig. 1, this cardiac pulse electric field ablation balloon catheter includes: the catheter comprises a catheter rod, an outer balloon, an inner balloon, a fixing rod, at least one ablation electrode and at least one mapping electrode; the inner balloon is positioned inside the outer balloon, the fixing rod penetrates through the inner balloon and the outer balloon, one end of the fixing rod is connected with the tail end of the catheter rod, the fixing rod is communicated with the catheter rod, the outer balloon and the inner balloon, at least one ablation electrode and at least one mapping electrode are arranged on the surface of the outer balloon, and electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with a circuit channel of the catheter rod.
Specifically, the fixing rod is used for fixing the outer balloon and the inner balloon, the fixing rod can be of a rod-shaped structure, and the specific setting position of the fixing rod can penetrate through the spherical centers of the outer balloon and the inner balloon and is coaxial with the catheter rod. The inner balloon and the outer balloon are in a sealed state.
The embodiment of the utility model provides an in, through interior sacculus and outer sacculus, can provide certain holding power, be favorable to melting pasting of electrode, improve and melt efficiency, through set up the mark survey electrode on outer sacculus, need not additionally to use mark survey electrode to carry out the monitoring of pulmonary vein electric potential activity, can detect the electrophysiological activity in the pulmonary vein when melting, the cost has been practiced thrift to a certain extent, and then solved among the prior art based on the mode that the pulse electric field melts and local myocardium contact surface limited and can't present the technical problem of the inside electric potential of pulmonary vein.
In an alternative embodiment, the outer balloon and the inner balloon are each ellipsoidal in configuration when in the inflated state.
Alternatively, the outer balloon may be an ellipsoid with a diameter of 23mm to 30mm, and the inner balloon may be an ellipsoid with a diameter 2mm smaller than the outer balloon.
It should be noted here that, in this embodiment, the diameter data of the outer balloon and the inner balloon are data in a bulging state, and the outer balloon and the inner balloon are in an ellipsoidal structure when in use, that is, when gas or a liquid agent is injected, where the liquid agent may be a contrast medium; when not in use, the structure is indefinite, and the device is in a contracted state.
In an alternative embodiment, the outer balloon and the inner balloon are both made of flexible medical polymer composite materials and can deform when gas or liquid is injected.
In an alternative embodiment, the outer balloon is of a double-layer structure and comprises an outer balloon and an inner balloon, and an intermediate layer is formed between the outer balloon and the inner balloon.
In an alternative embodiment, the intermediate layer is a negative pressure vacuum, and the electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with the circuit channel of the catheter shaft through the intermediate layer.
Specifically, the intermediate layer is an electrode wire passing region, and optionally, the electrode wire of the ablation electrode and the electrode wire of the mapping electrode can be separately bundled and deformed.
In an alternative embodiment, the fixing rod is provided with a first channel communicated with the catheter rod along the axial direction, a second channel communicated with the middle layer, a third channel communicated with the cavity between the outer balloon and the inner balloon and a fourth channel communicated with the inner balloon are arranged on the side surface of the fixing rod, and the second channel, the third channel and the fourth channel are sequentially arranged along the direction far away from the tail end of the catheter rod.
In particular, the fixation rod may be a hollow structure, thereby forming a first channel in communication with the catheter rod, in particular in communication with the distal end of the catheter rod. Specifically, a cavity with the volume of 1-8ml can be arranged between the outer balloon and the inner balloon and is communicated with a third channel of the fixing rod; through the first channel, the second channel, the third channel and the fourth channel, pressurized gas or contrast agent can be injected into the inner saccule and the outer saccule, the position of the catheter can be more accurately guided under fluoroscopy, and the surgical positioning is facilitated.
In an alternative embodiment, the catheter shaft and the fixation rod are coaxial, the at least one ablation electrode is disposed uniformly along the outer surface of the outer balloon at its maximum diameter, and the outer balloon at its maximum diameter is perpendicular to the catheter shaft.
Optionally, 8-10 ablation electrodes can be uniformly arranged along the outer surface of the outer balloon with the largest diameter, and can be completely attached to the pulmonary veins through the distribution arrangement, so that the ablation efficiency is increased.
In an alternative embodiment, the catheter shaft and the fixation rod are coaxial, the at least one mapping electrode is disposed at least one turn uniformly along the outer surface of the outer balloon, and each turn forms a plane perpendicular to the catheter shaft.
Optionally, 2 circles of mapping electrodes may be provided, and 8 mapping electrodes may be provided for each circle, so as to monitor the activity of the pulmonary vein potential.
In an alternative embodiment, the at least one ablation electrode and the at least one mapping electrode are arranged parallel to each other, and the at least one mapping electrode is arranged on the distal side of the at least one ablation electrode away from the catheter shaft.
In an alternative embodiment, the ablation electrode is of a rectangular structure, and the material of the ablation electrode is iridium platinum; the marking electrode is of a rectangular structure and is made of iridium platinum.
Specifically, the major diameter of the ablation electrode can be 2mm, the minor diameter can be 1mm, and each ablation electrode is formed by an electrode lead; the long diameter of the mapping electrode can be 1.5mm, the short diameter can be 1mm, and each mapping electrode is connected by an electrode lead.
In an alternative embodiment, the catheter shaft terminates in a rounded, resilient tip.
In a specific embodiment, when melting, interior sacculus and outer sacculus are all not aerifyd, use the utility model discloses a pipe accessible interatrial septum puncture sheath pipe stretches into the left atrium, when control pipe stretched into a certain pulmonary vein with its end slightly, can make the sacculus uplift through the sacculus in the injection of pressurized gas or agent liquid, through further adjusting the position, and inject the contrast medium into inside and outside sacculus middle chamber, make the sacculus profile clearly visible under the perspective, and make the sacculus totally uplift, be fixed in on the pulmonary vein mouth, the dead lever passageway was injected the contrast medium into the pulmonary vein in the contrast medium accessible simultaneously, accomplish the pulmonary vein radiography, if sacculus position shutoff is appropriate, with no contrast medium backward flow. Meanwhile, the marking electrode at the front end of the balloon can record the electrical activity in the pulmonary vein, and a plurality of or 10 kilovolt-level instantaneous voltages are applied to the balloon ablation electrode through a pulsed electric field ablation instrument, so that the annular ablation of the mouth part of the pulmonary vein can be completed, and if the ablation is successful, the electric potential of the distal pulmonary vein disappears.
The above embodiment numbers of the present invention are only for description, and do not represent the advantages and disadvantages of the embodiments.
In the above embodiments of the present invention, the descriptions of the respective embodiments have respective emphasis, and for parts that are not described in detail in a certain embodiment, reference may be made to the related descriptions of other embodiments.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
Unless specifically stated otherwise, the relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present invention. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.
In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the orientation words such as "front, back, up, down, left, right", "horizontal, vertical, horizontal" and "top, bottom" etc. are usually based on the orientation or positional relationship shown in the drawings, and are only for convenience of description and simplification of description, and in the case of not making a contrary explanation, these orientation words do not indicate and imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore, should not be interpreted as limiting the scope of the present invention; the terms "inner and outer" refer to the inner and outer relative to the profile of the respective component itself.
Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and if not stated otherwise, the terms have no special meaning, and therefore, the scope of the present invention should not be construed as being limited.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, a plurality of modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims (10)

1. A cardiac pulsed electric field ablation balloon catheter, comprising: the catheter comprises a catheter rod, an outer balloon, an inner balloon, a fixing rod, at least one ablation electrode and at least one mapping electrode;
the inner balloon is positioned inside the outer balloon, the fixing rod penetrates through the inner balloon and the outer balloon, one end of the fixing rod is connected with the tail end of the catheter rod, the fixing rod is communicated with the catheter rod, the outer balloon and the inner balloon, the surface of the outer balloon is provided with the at least one ablation electrode and the at least one mapping electrode, and electrode wires of the at least one ablation electrode and the at least one mapping electrode are connected with a circuit channel of the catheter rod.
2. The catheter of claim 1, wherein the outer balloon is a double-layer structure comprising an outer balloon and an inner balloon, and an intermediate layer is formed between the outer balloon and the inner balloon.
3. The catheter of claim 2, wherein the intermediate layer is a negative pressure vacuum, and the electrode wires of the at least one ablation electrode and the at least one mapping electrode are each connected to the circuit channel of the catheter shaft through the intermediate layer.
4. The catheter of claim 2, wherein the fixing rod is provided with a first channel communicating with the catheter shaft in an axial direction, and a second channel communicating with the intermediate layer, a third channel communicating with the cavity between the outer balloon and the inner balloon, and a fourth channel communicating with the inner balloon are provided on a side surface of the fixing rod, wherein the second channel, the third channel, and the fourth channel are provided in this order in a direction away from the distal end of the catheter shaft.
5. The catheter of claim 1, wherein the catheter shaft and the fixation rod are coaxial, the at least one ablation electrode is disposed uniformly along the outer balloon maximum diameter outer surface, and the outer balloon maximum diameter is perpendicular to the catheter shaft.
6. The catheter of claim 1, wherein the catheter shaft and the fixation rod are coaxial, the at least one mapping electrode is disposed in at least one turn uniformly along the outer balloon surface, and each turn forms a plane perpendicular to the catheter shaft.
7. The catheter of claim 5 or 6, wherein the at least one ablation electrode and the at least one mapping electrode are disposed parallel to each other, and the at least one mapping electrode is disposed on a distal side of the at least one ablation electrode from the catheter shaft.
8. The catheter of any one of claims 1-6, wherein the ablation electrode is rectangular in configuration and is made of iridium platinum; the marking electrode is of a rectangular structure and is made of iridium platinum.
9. The catheter of any one of claims 1-6, wherein the outer balloon and the inner balloon are both made of a flexible medical polymer composite material that deforms upon injection of a gas or fluid.
10. The catheter of any one of claims 1-6, wherein the outer balloon and the inner balloon are each of an ellipsoidal configuration in the inflated state.
CN202021279130.0U 2020-07-01 2020-07-01 Cardiac pulse electric field ablation balloon catheter Active CN213075899U (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113425402A (en) * 2021-08-27 2021-09-24 上海安钛克医疗科技有限公司 Catheter capable of judging balloon adhesion and ablation system
CN113952020A (en) * 2021-11-10 2022-01-21 心航路医学科技(广州)有限公司 Sacculus-shaped pulse electric field ablation device
CN114027967A (en) * 2021-11-10 2022-02-11 心航路医学科技(广州)有限公司 Pulsed electric field balloon component and ablation catheter device using same
CN114469324A (en) * 2022-01-26 2022-05-13 中国医学科学院阜外医院 Radio frequency ablation catheter and radio frequency ablation system
CN115813398A (en) * 2023-02-17 2023-03-21 四川锦江电子医疗器械科技股份有限公司 Balloon electrode catheter and using method thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113425402A (en) * 2021-08-27 2021-09-24 上海安钛克医疗科技有限公司 Catheter capable of judging balloon adhesion and ablation system
CN113425402B (en) * 2021-08-27 2021-12-17 上海安钛克医疗科技有限公司 Catheter capable of judging balloon adhesion and ablation system
CN113952020A (en) * 2021-11-10 2022-01-21 心航路医学科技(广州)有限公司 Sacculus-shaped pulse electric field ablation device
CN114027967A (en) * 2021-11-10 2022-02-11 心航路医学科技(广州)有限公司 Pulsed electric field balloon component and ablation catheter device using same
CN114469324A (en) * 2022-01-26 2022-05-13 中国医学科学院阜外医院 Radio frequency ablation catheter and radio frequency ablation system
CN114469324B (en) * 2022-01-26 2022-10-11 中国医学科学院阜外医院 Radio frequency ablation catheter and radio frequency ablation system
CN115813398A (en) * 2023-02-17 2023-03-21 四川锦江电子医疗器械科技股份有限公司 Balloon electrode catheter and using method thereof

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Effective date of registration: 20210909

Address after: 100013 Anzhenli, andingmenwai, Chaoyang District, Beijing

Patentee after: BEIJING ANZHEN HOSPITAL AFFILIATED TO CAPITAL MEDICAL University

Address before: 100029 Beijing city Chaoyang District anzhen Road No. 2

Patentee before: Long Deyong

Patentee before: Li Mengmeng

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