CN114305665A - Split-capsule electrode catheter and ablation device comprising same - Google Patents
Split-capsule electrode catheter and ablation device comprising same Download PDFInfo
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- CN114305665A CN114305665A CN202210110646.XA CN202210110646A CN114305665A CN 114305665 A CN114305665 A CN 114305665A CN 202210110646 A CN202210110646 A CN 202210110646A CN 114305665 A CN114305665 A CN 114305665A
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Abstract
The present disclosure relates to an electrode catheter, including: a bladder comprising at least three bladder subsections, the bladder subsections each having a contracted state and an expanded state, and wherein the at least three bladder subsections are each capable of having an expanded state of differing degrees of expansion; at least three sets of electrode pads associated with the at least three bladder subsections; and a control portion configured to control a degree of expansion of the at least three bladder subsections. The present disclosure innovatively proposes that by dividing the balloon into a plurality of saccular sub-portions, each saccular sub-portion can have different degrees of expansion, so that the finally formed ablation shape has variability, can be adapted to different shapes of target tissues, and achieves better attachment, thereby achieving a better ablation effect.
Description
Technical Field
The present disclosure relates to the field of medical devices, and more particularly, to a split-balloon electrode catheter and an ablation device including the same.
Background
Atrial Fibrillation (AF) is a common cardiac arrhythmia affecting the lives of over 3300 million people worldwide. Radiofrequency ablation and cryoablation are two common methods currently used clinically to treat cardiac arrhythmias such as atrial fibrillation. Both types of ablation must be sufficiently damaging to the arrhythmic tissue or to substantially interfere with or isolate abnormal electrical conduction in the myocardial tissue, while excessive ablation may affect surrounding healthy tissue as well as neural tissue, but insufficient ablation may not serve to block abnormal electrical conduction. Therefore, it is critical to produce a suitable ablation zone.
The radio frequency ablation adopts point-by-point ablation, the operation time is long, the requirement on the catheter operation level of an operator (such as a doctor) is high, discomfort can be caused due to the long time during the operation of a patient, and the problems of pulmonary vein stenosis and the like easily occur after the operation. In addition, radiofrequency ablation can damage the cardiac endothelial surface, activate the extrinsic coagulation cascade and lead to coke and thrombosis, which in turn can lead to systemic thromboembolism. It follows that the application of radio frequency energy to target tissue can have an effect on non-target tissue, for example, the application of radio frequency energy to atrial wall tissue can cause damage to the digestive system, such as the esophagus, or the nervous system. Radiofrequency ablation may also lead to scarring of the tissue, further leading to embolization problems. Cryoablation has a high probability of causing phrenic nerve damage, and epicardial freezing near the coronary arteries can also lead to thrombosis and progressive coronary stenosis.
At present, most of the main pulmonary vein ablation catheters are single-point ablation catheters (radio frequency) and balloon, basket-shaped or annular ablation catheters, and the main pulmonary vein ablation catheters have the defects that the range of an electric field generated by the single-point ablation catheter or the annular ablation catheter is small, the requirement on operation is high, and the operation is time-consuming. The basket-shaped catheter and the balloon-shaped catheter are both in a certain shape, so that the catheter cannot be suitable for pulmonary vein ablation in irregular shapes such as an ellipse, and the electrodes are difficult to completely attach.
Disclosure of Invention
In view of the deep understanding of the problems existing in the background art, that is, most of the existing main electrode catheters are basket-shaped or balloon-shaped, but the basket-shaped or balloon-shaped catheters have certain shapes and cannot be applied to ablation of target tissues with irregular shapes such as ellipses, and the electrodes are difficult to be completely attached to each other, the inventor of the present disclosure proposed a split balloon electrode catheter in the present application, which has a plurality of split balloons, and can individually control the expansion degree of each split balloon, so as to be adapted to ablation of target tissues with irregular shapes.
Specifically, a first aspect of the present disclosure proposes an electrode catheter including: a bladder comprising at least three bladder subsections, the bladder subsections each having a contracted state and an expanded state, and wherein the at least three bladder subsections are each capable of having an expanded state of differing degrees of expansion; at least three sets of electrode pads associated with the at least three bladder subsections; and a control portion configured to control a degree of expansion of the at least three bladder subsections. The present disclosure innovatively proposes that by dividing the balloon into a plurality of saccular sub-portions, each saccular sub-portion can have different degrees of expansion, so that the finally formed ablation shape has variability, can be adapted to different shapes of target tissues, and achieves better attachment, thereby achieving a better ablation effect.
In one embodiment according to the present disclosure, a first bladder sub-portion of the at least three bladder sub-portions is inflated to a different degree than a second bladder sub-portion of the at least three bladder sub-portions. In this way different degrees of expansion can be achieved, enabling a non-perfect circular ablation shape, which in turn can be adapted to different target tissues. Optionally, in an embodiment according to the present disclosure, the electrode catheter further includes: a wire configured to power the at least three sets of electrode pads. In this way, the individual electrode pads can be supplied with power in order to achieve an ablation electrical field.
Preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: at least three pressure sensors associated with the at least three bladder subsections and configured to measure an abutting pressure between the bladder subsection associated therewith and the target tissue. In this way, the contact pressure between the capsule sub-portion associated with the respective pressure sensor and the target tissue can be measured. Those skilled in the art will appreciate that the contact between the capsule sub-portion and the target tissue can be determined by a lower pressure when the capsule sub-portion associated with the corresponding pressure sensor is not in contact with the target tissue and a higher pressure when the capsule sub-portion associated with the corresponding pressure sensor is in contact with the target tissue.
In one embodiment according to the present disclosure, the control portion is configured to control a degree of expansion of the bladder sub-portion based on the measured seating pressure. In this way, the degree of expansion of the capsule sub-portion can be controlled in a relatively precise manner, and good abutment between the capsule sub-portion and the target tissue can be achieved.
Preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: an electrode substrate disposed between the electrode pad and the pressure sensor. More preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: a pressure sensing substrate disposed between the pressure sensor and the bladder sub-portion.
Further preferably, in an embodiment according to the present disclosure, the electrode catheter further includes: a distal rod disposed on a first end of the bladder; and a connector disposed on the distal stem and configured to connect the at least three bladder subsections. More preferably, in one embodiment according to the present disclosure, the connecting member is configured as a flexible gasket. Optionally, in one embodiment according to the present disclosure, the at least three sets of electrode pads are disposed on a half side of the bladder near the first end and at equal distances from the first electrode. Preferably, in one embodiment according to the present disclosure, the bladder sub-portion is configured as a split balloon.
Preferably, in one embodiment according to the present disclosure, the electrode catheter further includes a pressurization tube in fluid communication with the bladder sub-portion via a second end distal from the first end and configured to control the transition of the bladder sub-portion between the contracted state and the expanded state and having a corresponding degree of expansion. In this way, the control of the degree of expansion of the individual capsule sub-parts can be achieved in a relatively simple manner, and a good contact between the capsule sub-parts and the target tissue is ensured. Preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: an inner tube having a lumen to receive a guidewire and/or a mapping catheter; and an outer tube that is wrapped outside the inner tube, wherein the pressurizing tube is provided between the inner tube and the outer tube. More preferably, in one embodiment according to the present disclosure, the electrode catheter further includes an intermediate tube disposed between the pressurizing tube and the outer tube and a lead wire for supplying power to the electrode pad is disposed between the intermediate tube and the outer tube.
Optionally, in one embodiment according to the present disclosure, the bladder in the inflated state is a spherical bladder or a conical bladder. Preferably, in one embodiment according to the present disclosure, the electrode catheter further comprises a handle, the handle having an electrode power supply interface and a fluid input/output port in fluid communication with the bladder.
Furthermore, a second aspect of the present disclosure proposes an ablation apparatus comprising: a pulse signal generator configured to generate a pulse signal; and an electrode catheter according to the first aspect of the present disclosure, the electrode catheter being electrically connected with the pulse signal generator. Preferably, in one embodiment according to the present disclosure, the ablation apparatus further comprises: an operation control part configured to control the pulse signal generator and manipulate the electrode catheter.
In summary, the present disclosure innovatively proposes that the balloon is divided into a plurality of saccular sub-portions, and each saccular sub-portion can have different degrees of expansion, so that the finally formed ablation shape has variability, can be adapted to different shapes of target tissues, and achieves better adhesion, thereby achieving better ablation effect.
Drawings
Embodiments are shown and described with reference to the drawings. These drawings are provided to illustrate the basic principles and thus only show the aspects necessary for understanding the basic principles. The figures are not to scale. In the drawings, like reference numerals designate similar features.
FIG. 1 shows a schematic view of an electrode catheter 100 according to one embodiment of the present disclosure;
FIG. 2 illustrates a partial cross-sectional view of the electrode catheter 100 of the embodiment of FIG. 1 in accordance with the present disclosure;
FIG. 3A illustrates a top view of a first expanded state of an electrode catheter in accordance with one embodiment of the present disclosure;
FIG. 3B illustrates a top view of a second expanded state of the electrode catheter in accordance with one embodiment of the present disclosure;
FIG. 3C illustrates a top view of a third expanded state of the electrode catheter in accordance with one embodiment of the present disclosure;
FIG. 4 illustrates an exploded structural view of an electrode sheet for use with an electrode catheter in accordance with yet another embodiment of the present disclosure;
FIG. 5 illustrates a partially exploded view of an electrode catheter in accordance with yet another embodiment of the present disclosure;
FIG. 6 illustrates an exploded view of an electrode catheter in accordance with yet another embodiment of the present disclosure; and
fig. 7 shows a schematic view of the position of the catheter with the target tissue at the time of ablation by means of the electrode disclosed according to the present disclosure.
Other features, characteristics, advantages and benefits of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.
Detailed Description
In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part hereof. The accompanying drawings illustrate, by way of example, specific embodiments in which the disclosure can be practiced. The example embodiments are not intended to be exhaustive of all embodiments according to the disclosure. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present disclosure is defined by the appended claims.
The technique used in this disclosure to treat atrial fibrillation is a pulsed electric field technique that applies a brief high voltage to the target tissue cells that can produce a high voltage electric field. The local high voltage electric field destroys the cell membrane by forming a puncture in the cell membrane where the applied electric field is above the cell threshold so that the puncture does not reclose, thereby making such electroporation irreversible. The perforation will allow the exchange of biomolecular material across the cell membrane, resulting in necrosis or apoptosis of the cell.
Since different tissue cells have different voltage penetration thresholds, the high voltage pulse technique can selectively treat myocardial cells with relatively low thresholds without affecting other non-target cell tissues, such as nerve cells, esophageal cells, vascular cells, and blood cells. Meanwhile, the time for releasing energy is very short, so that the pulse electric field technology cannot generate obvious thermal effect, and the problems of tissue damage, pulmonary vein stenosis and the like are avoided.
In particular, pulsed electric field (PET) ablation is a non-thermal damage technique, the damage mechanism being the appearance of nano-scale pores in certain cell membranes by high frequency electrical pulses. Potential advantages of the PET ablation technique that can be used for atrial fibrillation ablation include the following: firstly, the PET ablation technology can pertinently select or avoid target tissues by setting different threshold values, so that surrounding tissues can be protected from being damaged; secondly, the PET ablation technology can be rapidly released within a few seconds, namely the treatment time of the cells of the target tissue is short, and the cells are easy to accept by a user; furthermore, compared to cryoablation, PET ablation does not produce coagulation necrosis, thereby reducing the risk of Pulmonary Vein (PV) stenosis.
Therefore, pulsed electric field technology is increasingly used in clinical activities due to its advantages of non-thermal and cell selectivity.
However, the inventors of the present disclosure have recognized that there are problems in the prior art, namely: at present, most of the main pulmonary vein ablation catheters are single-point ablation catheters (radio frequency) and balloon, basket-shaped or annular ablation catheters, and the main pulmonary vein ablation catheters have the defects that the range of an electric field generated by the single-point ablation catheter or the annular ablation catheter is small, the requirement on operation is high, and the operation is time-consuming. In addition, the basket-shaped catheter and the balloon-shaped catheter are both in a certain shape, so that the catheter cannot be suitable for pulmonary vein ablation in irregular shapes such as an ellipse, and the electrodes are difficult to completely attach.
In view of the above technical problems, the inventors of the present disclosure provide a split balloon electrode catheter having a plurality of split balloons, each of which can be individually inflation-controlled. In addition to applying the split-balloon technique, the present disclosure preferably controls the point in time at which inflation ceases by pressure sensing under the electrodes, so that the catheter can achieve different degrees of inflation in multiple directions to better abut target tissue such as irregular pulmonary veins, achieving full abutment of each electrode, and improving ablation.
Specifically, the structure of the electrode catheter and the structure of the corresponding ablation apparatus according to the present disclosure will be described below with reference to fig. 1 to 7.
Fig. 1 shows a schematic view of an electrode catheter 100 according to one embodiment of the present disclosure. As can be seen in fig. 1, the electrode catheter 100 disclosed in accordance with the present disclosure includes a bladder 110, the bladder 110 including at least three bladder sub-portions, and in the embodiment shown in fig. 1, the bladder 110 includes eight bladder sub-portions, such as bladder sub-portions 111, 112, 113, 114 and 115, and three other bladder sub-portions are not explicitly shown as being on the back side. These illustrated five bladder sub-portions 111, 112, 113, 114 and 115 and the three bladder sub-portions not shown have a contracted state and an expanded state, respectively, and wherein the above-described illustrated five bladder sub-portions 111, 112, 113, 114 and 115 and the three bladder sub-portions not shown can have expanded states of different degrees of expansion, respectively. It will be appreciated by those skilled in the art that the five bladder subsections 111, 112, 113, 114, and 115 illustrated above, as well as the three bladder subsections not illustrated, can have either the same degree of inflation at the same time or different degrees of inflation. For example, for a regular target structure, if the diameter of the target structure is small, for example, the above-mentioned five bladder subsections 111, 112, 113, 114 and 115 shown and the three bladder subsections not shown are inflated by 50% each, i.e. a degree of expansion of 50% is simultaneously achieved, if good abutment can be achieved at this time, the technical object according to the disclosure can be achieved; for a regular target structure of larger dimensions, if the diameter of the target structure is larger, for example, the above-mentioned five bladder subsections 111, 112, 113, 114 and 115 and the three bladder subsections not shown are inflated by 90% each, i.e. a degree of expansion of 90% is simultaneously achieved, if good abutment is achieved at this time, the technical object according to the disclosure can be achieved. For irregular target structures, the above-mentioned five bladder subsections 111, 112, 113, 114 and 115 and the three bladder subsections not shown can each be expanded to different degrees, with the ultimate goal of achieving a good fit. Specific implementations are described in detail below with reference to the accompanying drawings.
In concert with the bladder sub-portions, the electrode catheter 100 according to the present disclosure also includes corresponding electrode pads that correspond one-to-one with the bladder sub-portions. As shown in fig. 1, the electrode catheter 100 disclosed in accordance with the present disclosure also includes at least three sets of electrode pads associated with the at least three bladder subsections. In the embodiment illustrated in fig. 1, the electrode catheter 100 disclosed in accordance with the present disclosure includes eight sets of electrode pads, namely five sets of electrode pads 121, 122, 123, 124, and 125 associated with the five bladder subsections 111, 112, 113, 114, and 115 shown. In addition, the three sets of electrode pads associated with the three bladder subsections, not shown, are not explicitly listed with reference numerals because they are provided on the back surface. Furthermore, in order to control the state of the bladder sub-portions, the electrode catheter 100 according to the present disclosure further includes a control portion (not shown in the figures) configured to control the degree of expansion of the at least three bladder sub-portions. Therefore, the balloon is divided into a plurality of saccular sub-parts, and each saccular sub-part can have different expansion degrees, so that the finally formed ablation shape has variability, can be suitable for different shapes of target tissues, and achieves better pasting, thereby achieving better ablation effect.
Furthermore, while eight bladder subsections are shown in fig. 1, eight are exemplary only and not limiting, as long as different inflation states can be achieved to abut the target tissue and are intended to fall within the scope of the claims of the present application. That is, the electrode conduit claimed in accordance with the present disclosure may, for example, have only three bladder subsections or may have more bladder subsections. Further, each set of electrode sheets shown in fig. 1 described above has three electrode sheets, but the three electrode sheets forming one set of electrode sheets are also exemplary and not limiting. That is, each set of electrode pads in an electrode catheter 100 as claimed in accordance with the present disclosure may, for example, have only one electrode pad or may also have more electrode pads.
In order to control the degree of expansion of each of the bladder subsections, a gas generator may be provided, for example, inside the bladder subsection, which may control the degree of expansion of the bladder subsection by controlling the amount of gas inside the bladder subsection, for example, in accordance with a control signal received from the outside.
In addition, the bladder sub-portion may be communicated with the outside by means of, for example, a duct, so that the degree of expansion of the bladder sub-portion can be controlled by means of the duct. To this end, fig. 2 illustrates a partial cross-sectional view of the electrode catheter 100 of the embodiment of fig. 1 in accordance with the present disclosure. As can be seen from fig. 2, the electrode catheter further comprises a pressurizing tube 131, wherein the number of pressurizing tubes may be eight, for example, and the other three are omitted because they are not shown in the cross-sectional view. The pressurization tube is in fluid communication with the bladder sub-portion via an end remote from a bladder free end and is configured to control the transition of the bladder sub-portion between the contracted state and the expanded state and has a corresponding degree of expansion. In this way, the control of the degree of expansion of the individual capsule sub-parts can be achieved in a relatively simple manner, and a good contact between the capsule sub-parts and the target tissue is ensured.
Furthermore, as can be seen in fig. 2, the electrode catheter 100 as claimed in accordance with the present disclosure further includes an inner tube 140, the inner tube 140 being endoluminally configured for placement of a guidewire and/or a mapping catheter. The electrode catheter 100 as claimed in accordance with the present disclosure further includes an outer tube 160 for accommodating the lead wire, the pressurizing tube 131, the inner tube 140, and the like, the outer tube 160. Furthermore, the electrode catheter 100 as claimed in accordance with the present disclosure can further include an intermediate tube 150. The pressurized tube 131 can be received within the lumen of the intermediate tube 150 and a flexible material substrate (such as a wire) can be positioned between the intermediate tube 150 and the outer tube 160.
Before bladder 110 has reached the target location, bladder 110 assumes, for example, a contracted state in which the thickness of bladder 110 and outer tube 160 are similar, thereby allowing electrode catheter 100 with bladder 110 to be easily delivered to the target location, for example, via a venous blood vessel. After reaching the vicinity of the target position, each of the bladder parts of the bladder 110 can be switched from a contracted state to an expanded state, which is an expanded bladder part, for example, by the pressurizing tube 131 in the outer tube 160, so as to fit the tissue to be ablated, and after expansion, the shape of the bladder 110 can be finely adjusted, for example, by the pressurizing tube 131 in the outer tube 160, so that it fits the tissue to be ablated better, thereby improving the therapeutic effect. It will be appreciated by those skilled in the art that, optionally, assistance can also be performed during the above-described positioning procedure, for example, by means of an X-ray machine or by means of a contrast technique, in order to position the tissue precisely, providing a guarantee for a good subsequent ablation effect.
Furthermore, after, for example, ablation is completed, the ablation effect can be evaluated first, and then it is decided whether a predetermined ablation effect is achieved, to further decide whether supplemental ablation is required or the electrode catheter 100 can be withdrawn. After a predetermined ablation effect is achieved, prior to withdrawal of the electrode catheter 100, the respective bladder subsections of the bladder 110 can be switched from the expanded state to the contracted state again, for example, via the pressurization tube 131 within the outer tube 160, so that the electrode catheter 110 can be withdrawn with no or less damage to the venous vessel through which it is passed.
Control of the degree of expansion of the individual bladder subsections can be achieved by means of a pressurization tube 131 such as that shown in fig. 2, thereby providing assurance that good abutment between the bladder subsections and the target tissue is achieved. Fig. 3A illustrates a top view of a first expanded state of an electrode catheter in accordance with one embodiment of the present disclosure, fig. 3B illustrates a top view of a second expanded state of an electrode catheter in accordance with one embodiment of the present disclosure, and fig. 3C illustrates a top view of a third expanded state of an electrode catheter in accordance with one embodiment of the present disclosure. In the example shown in fig. 3A, the degrees of expansion of the respective bladder subsections are the same, and such a case is applied to, for example, a target tissue of a regular shape. And in the example shown in fig. 3B, the degree of expansion of the three bladder subsections on the right side is greater than the degree of expansion of the five bladder subsections on the left side. In the example shown in fig. 3C, the degree of expansion of the lower left and upper right bladder subsections is greater than the degree of expansion of the remaining six bladder subsections. In summary, in one embodiment according to the present disclosure, a first bladder sub-portion of the at least three bladder sub-portions expands to a different degree than a second bladder sub-portion of the at least three bladder sub-portions expands to a different degree. In this way different degrees of expansion can be achieved, enabling a non-perfect circular ablation shape, which in turn can be adapted to different target tissues.
Optionally, in an embodiment according to the present disclosure, the electrode catheter further includes: a wire configured to power the at least three sets of electrode pads. In this way, the individual electrode pads can be supplied with power in order to achieve an ablation electrical field.
In order to achieve a good contact, positioning can be assisted, for example, by means of images or the like, or can be achieved, for example, by measuring the contact pressure. To achieve the above object, the electrode catheter disclosed according to the present disclosure includes, for example, a plurality of pressure sensors in addition to the above-mentioned components. Fig. 4 illustrates an exploded structural view of an electrode sheet used by an electrode catheter in accordance with yet another embodiment of the present disclosure. As can be seen from fig. 4, each set of electrode pads 1211 can comprise, for example, a number of pressure sensors corresponding to the number of electrode pads, in the example shown in fig. 4, for example, three pressure sensors 1213, which are, for example, associated with a respective capsule subsection and are designed to measure the contact pressure between the associated capsule subsection and the target tissue. In this manner, the contact pressure between the bladder sub-portion associated with the respective pressure sensor 1213 and the target tissue can be measured.
Those skilled in the art will appreciate that the contact between the capsule sub-portion and the target tissue can be judged by making a pressure smaller when the capsule sub-portion associated with the corresponding pressure sensor 1213 is not in contact with the target tissue and making a pressure larger when the capsule sub-portion associated with the corresponding pressure sensor is in contact with the target tissue. With such a pressure sensor 1213, the control portion is configured to control the degree of expansion of the bladder sub-portion based on the measured abutment pressure. In this way, the degree of expansion of the capsule sub-portion can be controlled in a relatively precise manner, and good abutment between the capsule sub-portion and the target tissue can be achieved.
In another embodiment, the bladder sub-portion includes an impedance sensor thereon for measuring an impedance proximate the electrode pads and determining whether the electrode pads are in complete abutment with the target tissue based on the measured impedance. When the resistance value indicates that the abutment is not formed, the control section is configured to control the bladder sub-section to expand until the abutment is completed. In this way, the degree of expansion of the capsule sub-portion can be controlled in a relatively precise manner, and good abutment between the capsule sub-portion and the target tissue can be achieved.
Preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: an electrode substrate 1212, the electrode substrate 1212 being disposed between the electrode pads 1211 and the pressure sensor 1213. Here, the electrode pads may be either directly attached to the outer surface of bladder 110 or disposed on a flexible material substrate, i.e., electrode substrate 1212. The illustrated embodiment is an electrode pad disposed on an electrode base 1212, with one end of the electrode base 1212 fixedly attached to the distal shaft and one end communicating through a cavity between the intermediate tube 150 and the outer tube 160 to an external handle internal circuit board. A flexible spacer can fixedly connect each split balloon, i.e. the saccular sub-portion, the inner tube 140 is fixedly connected with the flexible spacer to provide a guide wire or mapping catheter access, the inner cavity of the middle tube 150 is provided with a number of pressurizing tubes 131 corresponding to the number of split balloons and one inner tube 140, and the pressurizing tubes 131 independently expand each split balloon, i.e. the saccular sub-portion.
More preferably, in one embodiment according to the present disclosure, the electrode catheter further includes: a pressure-sensing substrate 1214, the pressure-sensing substrate 1214 disposed between the pressure sensor 1213 and the bladder sub-portion. The electrode pads 1211 are substantially rectangular in shape, a long axis of the electrode pads 1211 is disposed along an axial direction of the electrode catheter 100 and the electrode pad length L is related to a preset shortest ablation width W in a vein axial direction and an ablation voltage V applied between the first electrode and the electrode pads 1211. For example, the long axis of the electrode sheet 1211 is disposed along the axial direction of the electrode catheter 100 including the bladder 110, and the length L of the electrode sheet 1211 is determined based on the preset ablation width W in the axial direction of the pulmonary vein and the ablation voltage V applied to the electrode sheet 1211. Through simulation, in the case of different electrode slice lengths L, for example, L is 3mm, 4mm, 5mm, 6mm or 7mm, the relationship between the ablation width W and the ablation voltage V exhibits the following relationship, for example: the ablation width W is approximately linear with the ablation voltage V and can therefore be fitted using the following fitting function:
W＝a1(L)V+a2(L) wherein a1(L) and a2(L) represents a function with respect to L.
Further optionally, in one embodiment according to the present disclosure, the bladder in the inflated state is a spherical bladder or a conical bladder. When high voltage pulses are used, the spherical balloon ablation results are better because the spacing between the electrodes is wider, allowing a wider ablation zone; in contrast, when low voltage pulses are used, the ablation results of the conical balloon are better because the ablation zone is not discontinuous due to the voltage drop because of the closer spacing between the electrodes. However, the balloon 110 of this embodiment, whether a spherical balloon or a conical balloon, does not have an ablation blind area in the ablating loop. Preferably, in one embodiment according to the present disclosure, the electrode catheter further comprises a handle, the handle having an electrode power supply interface and a fluid input/output port in fluid communication with the bladder.
Returning again to fig. 1, as shown in fig. 1, the electrode catheter 100 can further include a distal stem 170, the distal stem 170 being disposed on a first end (e.g., a free end) of the balloon 110. To achieve better ablation, the electrode catheter 100 disclosed in accordance with the present disclosure can further include a first electrode, for example, disposed on the distal shaft 170. More preferably, in an embodiment according to the present disclosure, an electric field formed between the at least three sets of electrode pads is orthogonal to an electric field formed between the at least three sets of electrode pads and the first electrode.
When a specific ablation is performed, a potential difference exists between the first electrode and each electrode pad of the eight groups of electrode pads in fig. 1. Here, for example, the first electrode is grounded, while the first group of electrode pads is connected to a positive pulse and the second group of electrode pads is connected to a negative pulse. For example, the polarities of the first and second electrode sheets may be different, and the polarity of the first electrode may be the same as that of one of the first and second electrode sheets, so that an electric field may be formed between the first electrode and the electrode sheet, so as to facilitate the subsequent ablation process.
Optionally, in one embodiment according to the present disclosure, the at least three sets of electrode pads are disposed on a half side of the bladder 110 near the first end and are equidistant from the first electrode. That is, for example, the first electrode sheet of each set of electrode sheets is equidistant from the first electrode, the second electrode sheet of each set of electrode sheets is equidistant from the first electrode, and the third electrode sheet of each set of electrode sheets is equidistant from the first electrode. By the arrangement, the ablation effect can be ensured to be in accordance with the expected effect, the size of the ablation zone can be minimized as small as possible, and the tissue which is not necessary to be ablated is prevented from being ablated. This is because if the electrode pads are arranged at unequal distances from the first electrode, the further electrode pads will form additional ablation zones, which however have little practical effect, i.e. ablation of the zones is not necessary.
Preferably, in one embodiment according to the present disclosure, the first electrode is configured as a ring-shaped electrode. Preferably, as can also be seen in fig. 1, in one embodiment according to the present disclosure, the bladder sub-portion is configured as a split balloon. The bladder 110 may be made of an insulating material such as PEBAX, PET, Nylon, TPU, etc. While the cross section of the wire can be, for example, circular or rectangular; the electrode 1211 is rectangular, the aspect ratio can be, for example, 2 to 5, preferably 3 to 4, the length of the electrode 1211 can be 1 to 20mm, the thickness can be 100nm to 100 μm, the electrode 1211 is uniformly distributed on the same cross section, and the length of each electrode may be uniform or non-uniform. The number of electrode sheets may be 6 to 10, preferably 8, for example 8 to 80. All the materials of the pipes can be selected from PEBAX, TPU, Nylon and the like, and the pipes can be braided by stainless steel to provide supporting strength. The diameter of the outer tube 160 is 8-15 Fr, wherein French (F or Fr) is the diameter unit of a catheter commonly used in the field of medical instruments, 3Fr is approximately equal to 1mm, and the outer tube 160 can be a single cavity or multiple cavities; the inner tube is a mapping electrode catheter/guidewire/contrast injection channel. The connection of the bladder and the outer pipe can adopt glue or a hot melting welding process; the electrode plate and the bladder and the lead and the bladder can be connected by glue, and the glue is preferably UV glue. Furthermore, the electrode catheter 100 can preferably also comprise a handle, which can be connected, for example, to the outer tube 160, said handle being provided with an electrode power supply interface connected to said conductor and a fluid input/output port in fluid communication with said bladder. Additionally, bladder 110 may have a working diameter of 5mm to 35mm, and may be attached by gluing, heat staking, welding, or the like.
Furthermore, an ablation device is proposed according to the present disclosure. That is, the present disclosure also relates to an ablation apparatus for irreversible electroporation having a pulse signal generator configured to generate a pulse signal, the electrode catheter being connected to the pulse signal generation module and transmitting the pulse signal to a target site through an electrode ring and an electrode pad of the electrode catheter. Furthermore, the ablation device comprises an electrode catheter 100 according to the above, said electrode catheter 100 being electrically connected to said pulse signal generator. Still further, optionally, the ablation device can further include an operation control part (e.g., the aforementioned handle) configured to control the pulse signal generator and manipulate the electrode catheter 100. Further, the ablation device can also include, for example, four interfaces that integrate, for example, a positive and negative electrical cable interface, a mapping electrode catheter 100/guidewire/contrast access interface, and a gas/liquid injection interface.
In a particular use, a vascular sheath is first placed into the bilateral femoral vein, for example using a femoral venipuncture. The coronary sinus electrode is sent to the right position through the left sheath tube; performing atrial septal puncture and left atrial and pulmonary vein angiography through the right femoral vein; then, replacing the pulse ablation delivery system; then, the electrode catheter 100 comprising the saccule and the mapping catheter are sent; then, mapping the catheter into a target vein of interest; each bladder sub-portion of bladder 110 is then subjected to, for example, an inflation or filling fluid treatment; finally, the pulmonary vein ostium is blocked by balloon 110 and ablation is performed. In a specific ablation procedure, a two-stage ablation can be performed, for example, the first stage performing the ablation, for example, only by means of an electric field in the direction of the dimension of the electrode sheet forming capsule 110 arranged on the capsule 110; ablation then follows in a second stage, for example by means of an electric field in the longitudinal direction of the first electrode and electrode sheet forming bladder 110.
A specific connection structure of respective portions constituting the electrode catheter according to the present disclosure is described below with reference to fig. 5 and 6. Wherein fig. 5 shows a partially exploded view of an electrode catheter in accordance with yet another embodiment of the present disclosure, and fig. 6 shows an exploded view of an electrode catheter in accordance with yet another embodiment of the present disclosure. As can be seen in fig. 5 and 6, the electrode catheter 100 further comprises a distal stem 170, the distal stem 170 being disposed on a first end (e.g., a free end) of the balloon 110. Furthermore, the electrode catheter 100 comprises a connecting element 171, the connecting element 171 being arranged on the distal shaft 170 and being configured for connecting the at least three bladder sub-sections 111, the connecting element 171 here being configured as a flexible gasket. Each bladder portion 111 can be connected to the connector 171, for example, at its free end, such that each bladder portion 111 can be connected together at its free end, thereby collectively securing the bladder formed by each individual bladder portion 111 together when in an expanded state, resulting in a complete bladder such that the electrode pads on its surface form a more complete and continuous ablation zone. Furthermore, as can also be seen from fig. 5 and 6, the electrode catheter 100 further comprises an inner tube 140 and an outer tube 160, wherein the inner tube 140 is configured to define the shape of the electrode catheter 100; and the outer tube 160 is wrapped outside the inner tube 140, and wherein the pressurizing tube 131 is disposed between the inner tube 140 and the outer tube 160. In addition, the electrode catheter 100 further includes an intermediate tube 150, the intermediate tube 150 being disposed between the pressurizing tube 131 and the outer tube 160 and a lead wire for supplying power to the electrode pad being disposed between the intermediate tube 150 and the outer tube 160. Further, as can be seen from fig. 5 and 6, the respective bladder sub-portions 111 can be identical in structure, i.e., each bladder sub-portion 111 is of the same material and properties, and can be replaced with another.
Fig. 7 shows a schematic view of the position of the electrode catheter 100 and the target tissue 200 at the time of ablation by means of the electrode according to the disclosure. As can be seen, ablation by means of an electrode pad disposed on the bladder 110 of the electrode catheter 100 and/or a first electrode disposed on the distal shaft enables a specific ablation zone to be formed, which is located between the non-ablated zones. Ideally, the ablation width of the ablation region is uniform, and the ablation region is continuously closed, i.e., no intermittent region is formed somewhere in the middle, so that the transmission path of the noise signal to the heart, which causes arrhythmia, can be successfully cut off.
In view of the foregoing, the present disclosure is innovatively directed. The split balloon electrode catheter provided by the disclosure can adapt to irregular pulmonary vein shapes, and complete attachment of the electrodes is realized. By combining the electrode catheter and the pulse ablation technology, the pulmonary vein can be ablated, and the drug-refractory and symptomatic recurrent paroxysmal atrial fibrillation can be treated. In summary, the present disclosure innovatively proposes that by dividing the balloon into a plurality of saccular subsections, each saccular subsection can have different degrees of expansion, so that the finally formed ablation shape has variability, can be adapted to different shapes of target tissues, and achieves better fit, and further achieves better ablation effect.
While various exemplary embodiments of the disclosure have been described, it will be apparent to those skilled in the art that various changes and modifications can be made which will achieve one or more of the advantages of the disclosure without departing from the spirit and scope of the disclosure. Other components performing the same function may be substituted as appropriate by those skilled in the art. It should be understood that features explained herein with reference to a particular figure may be combined with features of other figures, even in those cases where this is not explicitly mentioned. Further, the methods of the present disclosure may be implemented in either all software implementations using appropriate processor instructions or hybrid implementations using a combination of hardware logic and software logic to achieve the same result. Such modifications to the solution according to the disclosure are intended to be covered by the appended claims.
Claims (18)
1. An electrode catheter, characterized in that the electrode catheter comprises:
a bladder comprising at least three bladder subsections, the bladder subsections each having a contracted state and an expanded state, and wherein the at least three bladder subsections are each capable of having an expanded state of differing degrees of expansion;
at least three sets of electrode pads associated with the at least three bladder subsections; and
a control portion configured to control a degree of expansion of the at least three bladder subsections.
2. The electrode catheter of claim 1, wherein a first bladder sub-portion of the at least three bladder sub-portions expands to a different degree than a second bladder sub-portion of the at least three bladder sub-portions expands.
3. The electrode catheter of claim 1, further comprising:
a wire configured to power the at least three sets of electrode pads.
4. The electrode catheter of claim 1, further comprising:
at least three pressure sensors associated with the at least three bladder subsections and configured to measure an abutting pressure between the bladder subsection associated therewith and the target tissue.
5. The electrode catheter of claim 4, wherein the control portion is configured to control a degree of expansion of the bladder sub-portion based on the measured seating pressure.
6. The electrode catheter of claim 4, further comprising:
an electrode substrate disposed between the electrode pad and the pressure sensor.
7. The electrode catheter of claim 6, further comprising:
a pressure sensing substrate disposed between the pressure sensor and the bladder sub-portion.
8. The electrode catheter of claim 1, further comprising:
a distal rod disposed on a first end of the bladder; and
a connector disposed on the distal stem and configured to connect the at least three bladder subsections.
9. The electrode catheter of claim 8, wherein the connector is configured as a flexible gasket.
10. The electrode catheter of claim 8, wherein the at least three sets of electrode pads are disposed on a half side of the bladder proximate the first end and equidistant from the first electrode.
11. The electrode catheter of claim 1, wherein the bladder sub-portion is configured as a split balloon.
12. The electrode catheter of claim 1, further comprising a pressurization tube in fluid communication with the bladder sub-portion via a second end distal from the first end and configured to control the transition of the bladder sub-portion between the contracted state and the expanded state and having a corresponding degree of expansion.
13. The electrode catheter of claim 12, further comprising:
an inner tube having a lumen to receive a guidewire and/or a mapping catheter; and
an outer tube wrapped around the outer portion of the inner tube,
wherein the pressurization pipe is disposed between the inner pipe and the outer pipe.
14. The electrode catheter as claimed in claim 13, further comprising an intermediate tube disposed between the pressurizing tube and the outer tube and a lead wire for supplying power to the electrode pad is disposed between the intermediate tube and the outer tube.
15. The electrode catheter according to any one of the preceding claims, wherein the balloon is a spherical balloon or a conical balloon in the expanded state.
16. The electrode catheter of any one of claims 1 to 14, further comprising a handle having an electrode power supply interface and a fluid input/output port in fluid communication with the bladder disposed thereon.
17. An ablation device, characterized in that the ablation device comprises:
a pulse signal generator configured to generate a pulse signal; and
the electrode catheter of any one of claims 1 to 16, which is electrically connected with the pulse signal generator.
18. The ablation apparatus of claim 17, further comprising:
an operation control part configured to control the pulse signal generator and manipulate the electrode catheter.
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| CN202210110646.XA CN114305665A (en) | 2022-01-29 | 2022-01-29 | Split-capsule electrode catheter and ablation device comprising same |
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| CN202210110646.XA CN114305665A (en) | 2022-01-29 | 2022-01-29 | Split-capsule electrode catheter and ablation device comprising same |
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