CN112998844B - Balloon electrode catheter - Google Patents
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- CN112998844B CN112998844B CN202110163553.9A CN202110163553A CN112998844B CN 112998844 B CN112998844 B CN 112998844B CN 202110163553 A CN202110163553 A CN 202110163553A CN 112998844 B CN112998844 B CN 112998844B
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00541—Lung or bronchi
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- A—HUMAN NECESSITIES
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
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Abstract
The invention relates to a balloon electrode catheter which comprises an outer tube, a balloon, an electrode plate and an electrode lead. A first end of the outer tube is connected to a proximal end portion of the balloon; the electrode lead is arranged in the outer tube in a penetrating mode; the electrode plates are even in number, are uniformly arranged on the outer surface of the annular side wall of the balloon at the same height at positive and negative intervals, and are respectively connected with respective electrode leads; after the saccule is pressurized and expanded, the electrode slice can be attached to the pulmonary vein opening to form an annular ablation band. According to the balloon electrode catheter provided by the embodiment of the invention, the electrode plates are uniformly distributed on the surface of the balloon, so that an effective annular pulse electric field can be generated, target tissues are selectively ablated, and the damage to cells is reduced. When the balloon electrode catheter is attached to the pulmonary vein orifice which is usually in an oval shape, the shape of the pulmonary vein orifice can be changed by pressurizing the balloon, and the pulmonary vein orifices with different shapes can be easily attached.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a balloon electrode catheter.
Background
Atrial Fibrillation (AF) is a common cardiac arrhythmia affecting the health of over 3300 thousands of people worldwide. Radiofrequency ablation and cryoablation are two common methods currently used clinically to treat cardiac arrhythmias (e.g., atrial fibrillation), where ablation lesions must be sufficient to destroy arrhythmic tissue or substantially interfere with or isolate abnormal electrical conduction in myocardial tissue, but excessive ablation can affect surrounding healthy tissue as well as neural tissue. The radio frequency ablation point-by-point ablation operation has long time, high requirement on the catheter operation level of an operator, discomfort of a patient in the operation and easy pulmonary vein stenosis after the operation. 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. Meanwhile, the application of rf energy to the target tissue affects non-target tissue, and the application of rf energy to atrial wall tissue may cause esophageal or nerve damage. In addition, radiofrequency ablation can also lead to scarring of the tissue, further leading to embolization problems. Whereas cryoablation causes a high rate of phrenic nerve damage, epicardial freezing near the coronary arteries can lead to thrombosis and progressive coronary stenosis.
The most recent technology for treating atrial fibrillation is a high-voltage pulsed electric field technology, which applies a brief pulsed high voltage to tissue cells, can generate a local high-voltage electric field of several hundred volts per centimeter, which is higher than a cell voltage penetration threshold, thereby forming irreversible perforations in cell membranes to destroy the cell membranes, so that biomolecular materials are exchanged across the cell membranes, resulting in cell necrosis or apoptosis. Since different tissue cells have different voltage penetration thresholds, the high voltage pulsed electric field technique can be selectively applied to myocardial cells (relatively low threshold) without affecting other non-target cellular tissues (e.g., nerves, esophagus, blood vessels, and blood). And the time for releasing energy when the pulse electric field is applied is very short, and the thermal effect cannot be generated, so that the problems of tissue damage, pulmonary vein stenosis and the like are avoided. Thus, pulse ablation is a non-thermogenic technique, the mechanism of injury is the creation of nano-scale micro-pores in certain cell membranes by high-frequency electrical pulses, and potential advantages of pulse ablation for atrial fibrillation ablation include: the tissue selectivity is realized, and the surrounding tissues can be protected from being damaged; the pulse electric field can be released quickly within a few seconds; ③ no coagulation necrosis, and the risk of Pulmonary Vein (PV) stenosis is reduced.
The application of high-voltage pulse electric field technology to treat atrial fibrillation requires the use of a pulse ablation catheter. The tip of the currently known pulse ablation catheter usually uses one or more flexible electrode arms, mostly in the shape of ring, basket, flower, and its disadvantages mainly include: the electrode arms are made of nickel-titanium alloy or stainless steel and the like, the diameter of each electrode arm is about 1mm, and the electrode arms are easy to deform or cannot be well attached to the pulmonary vein openings due to different shapes of the pulmonary vein openings, are not easy to attach and are not well positioned; in the operation, the metal electrode arm is visible under x-ray, but the edge of the pulmonary vein orifice and the complete shape of the catheter head cannot be seen, and an operator cannot observe the blocking condition by injecting a contrast medium; because parameters such as the intensity of a high-voltage pulse electric field need to be calculated in advance, corresponding voltages need to be applied to the annular and flower-shaped electrode arm models for simulation, but the simulation effect is not ideal.
Disclosure of Invention
In order to solve the technical problems of poor positioning of the pulse ablation catheter, poor visibility under x-ray and unsatisfactory simulation electric field effect, the invention provides a balloon electrode catheter, which comprises an outer tube, a balloon, an electrode plate and an electrode lead, wherein the first end of the outer tube is connected to the proximal end part of the balloon; the electrode lead is arranged in the outer tube in a penetrating mode; the electrode plates are even in number, are uniformly arranged on the outer surface of the annular side wall of the balloon at the same height at positive and negative intervals, and are respectively connected with respective electrode leads; after the saccule is pressurized and expanded, the electrode slice can be attached to the pulmonary vein opening to form an annular ablation band.
In one embodiment, the electrode sheet is rectangular, the long axis of the electrode sheet is arranged along the axial direction of the balloon electrode catheter, and the electrode sheet length L is determined based on the preset shortest ablation width W in the axial direction of the pulmonary vein and the ablation voltage V applied to the electrode sheet 3.
In one embodiment, the electrode sheet length L is:
wherein the unit of the length L of the electrode slice is millimeter,
w is a preset shortest ablation width in mm in the axial direction of the pulmonary vein,
v is the voltage applied to the electrode sheet, and the unit is volt,
c1、c2、c3、c4is the coefficient value at a particular number of electrode slices.
In one embodiment, the width of the electrode plates ranges from 0.5 mm to 3mm, the thickness of the electrode plates ranges from 100nm to 0.2mm, the number of the electrode plates ranges from 6 to 10, and the diameter of the outer tube ranges from 9 Fr to 15 Fr.
In one embodiment, the width of the electrode sheet is 1.5mm, the number of the electrode sheets is 8,
c1＝-6.49x10-2，
c2＝1.30x10-4，
c3＝0.442，
c4＝-1.27。
in one embodiment, the electrode pads are disposed on the distal hemispheric side of the balloon.
In one embodiment, the balloon electrode catheter further comprises an inner tube relatively movably disposed within the lumen of the outer tube, the first end of the inner tube extending from the first end of the outer tube, the distal end of the balloon being secured to the first end of the inner tube.
In one embodiment, the balloon comprises a balloon main body and a balloon distal end connecting part, the balloon distal end connecting part is in a hollow cylindrical shape, an annular supporting part is sleeved on the first end of the inner pipe, and the balloon distal end connecting part is fixedly connected to the outer side of the supporting part.
In one embodiment, the balloon further comprises a balloon proximal end connecting part, the balloon proximal end connecting part is in a hollow cylindrical shape, and a groove for embedding the electrode lead is arranged on the outer surface of the balloon main body and/or the outer surface of the balloon proximal end connecting part.
In one embodiment, the electrode plate-type inflatable balloon further comprises an outer-layer balloon attached to the outer side of the balloon, and an electrode plate exposed area is arranged on the outer-layer balloon and corresponds to an electrode plate on the balloon.
In one embodiment, the outer balloon comprises an outer balloon main body, an outer balloon proximal connecting part and an outer balloon distal connecting part, wherein the outer balloon proximal connecting part and the outer balloon distal connecting part are respectively arranged at two ends of the outer balloon main body;
the balloon near-end connecting portion, the outer balloon near-end connecting portion and the first end of the outer tube are fixedly connected, the first end of the inner tube penetrates through the balloon near-end connecting portion and the outer balloon near-end connecting portion, and the balloon far-end connecting portion, the outer balloon far-end connecting portion and the first end of the inner tube are fixedly connected.
In one embodiment, the outer balloon body comprises an outer proximal balloon body and an outer distal balloon body which are separately arranged, and the electrode plates 3 are at least partially exposed between the outer proximal balloon body and the outer distal balloon body.
In one embodiment, a cover is further included for securing the electrode lead to the outer surface of the balloon body.
In one embodiment, the balloon electrode catheter further comprises an adjustable bending handle, and an electrode lead interface connected with the electrode lead, a gas or liquid injection interface communicated with the outer tube and a guide wire cavity interface communicated with the inner tube are arranged on the adjustable bending handle.
The invention has the beneficial effects that: according to the balloon electrode catheter provided by the embodiment of the invention, the electrode plates are uniformly distributed on the surface of the balloon, so that an effective annular pulse electric field can be generated, target tissues are selectively ablated, and the damage to cells is reduced. When the balloon electrode catheter is attached to the pulmonary vein orifice which is usually in an oval shape, the shape of the pulmonary vein orifice can be changed by pressurizing the balloon, and the pulmonary vein orifices with different shapes can be easily attached. After the saccule is pressurized and expanded, the contrast is obvious under the X-ray, and a doctor can easily observe the jointing condition of the saccule and a focus. After the saccule blocks the pulmonary vein opening, contrast agent can be injected to observe the saccule blocking condition. In addition, the invention also optimizes the number and the length of the electrode plates based on the deficiency of the ablation electric field generated by the balloon electrode, thereby reducing the ablation blind area and leading the ablation effect to be better.
Drawings
Fig. 1 is a schematic view of an assembled structure of a balloon electrode catheter according to a first embodiment of the present invention;
fig. 2 is a perspective view of a balloon electrode catheter according to a first embodiment of the present invention;
fig. 3 is a side view of a balloon electrode catheter according to a first embodiment of the present invention;
fig. 4 is a sectional view of a balloon electrode catheter according to a first embodiment of the present invention;
fig. 5 is a schematic view of an assembled structure of a balloon electrode catheter according to a second embodiment of the present invention;
fig. 6 is a perspective view of a balloon electrode catheter according to a second embodiment of the present invention;
fig. 7 is a side view of a balloon electrode catheter according to a second embodiment of the present invention;
FIG. 8a is a schematic view of a balloon electrode catheter set forth in accordance with a second embodiment of the present invention prior to pressurization;
FIG. 8b is a schematic view of a balloon electrode catheter in accordance with a second embodiment of the present invention after pressurization;
FIG. 9 is a schematic structural view of a balloon electrode catheter with an adjustable bending handle attached thereto according to a second embodiment of the present invention;
FIG. 10 is a schematic view of a simulation using a balloon electrode catheter of an embodiment of the present invention;
fig. 11 is an ablation simulation result of a balloon electrode catheter employing different numbers of electrode pads under the conditions of preset ablation voltage and electrode pad length;
fig. 12 shows a graph of ablation width W versus ablation voltage V for different electrode lengths L;
fig. 13 shows a graph of the parameter a2 versus the electrode length L.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to specific embodiments and the accompanying drawings. Those skilled in the art will appreciate that the present invention is not limited to the drawings and the following examples.
According to a first embodiment of the present invention, a balloon electrode catheter is provided, as shown in fig. 1 to 4, the balloon electrode catheter includes an outer tube 1, a balloon 2, an electrode sheet 3 and an electrode wire 4, a first end of the outer tube 1 is connected to a proximal end portion of the balloon 2; the electrode lead 4 is arranged in the outer tube 1 in a penetrating way; the electrode plates 3 are even, the positive and negative intervals are uniformly arranged on the annular side wall of the balloon 2 at the same height, the electrode plates 3 are positioned on the outer surface of the balloon 2, and the electrode plates 3 are respectively connected with respective electrode leads 4; after the sacculus 2 is pressurized and expanded, the electrode slice 3 can be attached to the pulmonary vein opening to form an annular ablation band.
The electrode plates which are uniformly distributed are arranged on the surface of the balloon 2 of the balloon electrode catheter provided by the embodiment of the invention, so that an effective annular pulse electric field can be generated, target tissues are selectively ablated, and the damage to cells is reduced. When the balloon 2 is attached to a generally oval pulmonary vein ostium, the shape of the pulmonary vein ostium can be changed by pressurizing the balloon 2, and pulmonary vein ostia of various shapes can be easily attached. After the saccule 2 is pressurized and expanded, the contrast is obvious under the X-ray, and a doctor can easily observe the attaching condition of the saccule 2 and a focus. After the sacculus 2 blocks the pulmonary vein opening, contrast agent can be injected to observe the sacculus blocking condition.
In this embodiment, the balloon 2 may be made of insulating materials such as PEBAX, PET, Nylon, TPU, etc., and includes a balloon main body 21, a balloon proximal end connecting portion 22, and a balloon distal end connecting portion 23, where the balloon proximal end connecting portion 22 and the balloon distal end connecting portion 23 are both hollow cylinders and respectively protrude outward and are disposed at two ends of the balloon main body 21. Also, on the outer surface of the balloon main body 21 and on the outer surface of the balloon proximal end connecting portion 22, there are provided grooves 5 for fitting the electrode wires 4. Those skilled in the art will appreciate that the grooves 5 may be provided only on the outer surface of the balloon main body 21 or the outer surface of the balloon proximal end connecting portion 22, and the grooves 5 can better position the electrode lead 4.
The first end of the outer tube 1 is attached to the proximal end of the balloon 2. Specifically, the first end of the outer tube 1 is sleeved outside the balloon proximal end connecting portion 22. The electrode wires 4 are multiple, the cross section of each electrode wire can be circular or rectangular, the electrode wires are arranged in the outer tube 1 in a penetrating mode, the first ends of the electrode wires 4 extend out from the space between the first end of the outer tube 1 and the balloon near-end connecting portion 22, the electrode wires 4 are embedded into the grooves 5 on the outer surface of the balloon main body 21 and/or the outer surface of the balloon near-end connecting portion 22, and the first ends of the electrode wires 4 are connected with the electrode plates 3 on the outer surface of the balloon 2 respectively.
In order to further fix the electrode lead 4 protruding out of the first end of the outer tube 1, in the present embodiment, a covering member 6 is additionally provided, and the covering member 6 covers the electrode lead 4 protruding out of the first end of the outer tube 1 for fixing the electrode lead 4 on the outer surface of the balloon main body 21. Wherein the covering member 6 is in a long shape, matching the shape of the groove 5 on the outer surface of the balloon body 21.
The electrode plates 3 are even in number, and are uniformly arranged on the outer surface of the annular side wall of the balloon main body 21 of the balloon 2 at the same height at positive and negative intervals. In the present embodiment, a plurality of electrode pads 3 are provided on the distal semispherical side of the balloon 2, and are connected to respective electrode leads 4. After the sacculus 2 is pressurized and expanded, the electrode plate 3 can be attached to the pulmonary vein opening to form an annular ablation band.
In the present embodiment, the balloon electrode catheter further comprises an inner tube 7, and the inner tube 7 is movably arranged in the inner cavity of the outer tube 1. The first end of the inner tube 7 extends from the first end of the outer tube 1, from the proximal end of the balloon 2 into the interior of the balloon 2, securing the distal end of the balloon 2 to the first end of the inner tube 7. Thus, a guidewire lumen may be formed through the hollow space of the inner tube 7, allowing passage of a mapping electrode catheter, guidewire, contrast agent, and the like; a gap is formed between the inner tube 7 and the outer tube 1, and the balloon 2 can be inflated by pressurizing or filling a liquid through the gap.
Specifically, a ring-shaped supporting member 8 is sleeved on the first end of the inner tube 7, and the balloon distal end connecting portion 23 is fixedly connected to the outer side of the supporting member 8. The support 8 can be used not only for distal support of the balloon 2, but also for positioning of the ostium of the pulmonary vein during the procedure.
When the balloon electrode catheter of the embodiment is used, the balloon electrode catheter is inserted into a blood vessel through the sheath tube 11, sent into a target vein, and used for pressurizing and positioning the balloon 2 to block a pulmonary vein orifice, and then voltage is applied to the electrode plate 3 through the electrode lead 4 to form an annular ablation band, so that ablation is performed on an ablation area.
It should be noted that, in the first embodiment of the present invention, the connection between the support member 8 and the balloon 2 and the connection between the balloon 2 and the outer tube 1 may be made by glue or a hot-melt welding process, and the connection between the support member 8 and the inner tube 7, the connection between the electrode plate 3 and the balloon 2, and the connection between the electrode lead 4 and the balloon 2 may be made by glue, and the glue is preferably UV glue.
According to the second embodiment of the present invention, as shown in fig. 5 to 8, a balloon electrode catheter with an outer balloon 9 is proposed, instead of the covering member 6 used in the first embodiment of the present invention, the outer balloon 9 is used to fix the electrode pads 3 and/or the electrode wires 4 on the outer surface of the balloon main body 21 of the balloon 2, and other structures of the balloon portion are the same as those of the first embodiment, and will not be described again.
Specifically, the outer layer balloon 9 is attached to the outer side of the balloon main body 21, and electrode plate exposed areas are arranged on the outer layer balloon 9 and correspond to the electrode plates 3 on the balloon 2.
The outer balloon comprises an outer balloon main body 91, an outer balloon proximal end connecting portion 92 and an outer balloon distal end connecting portion 93, wherein the outer balloon proximal end connecting portion 92 and the outer balloon distal end connecting portion 93 are respectively arranged at two ends of the outer balloon main body 91. The balloon proximal end connecting part 22 and the outer balloon proximal end connecting part 92 are fixedly connected with the first end of the outer tube 1. The first end of the inner tube 7 passes through the balloon proximal connection 22 and the outer balloon proximal connection 92. The balloon distal end connecting portion 23, the outer balloon distal end connecting portion 93 and the first end of the inner tube 7 are fixedly connected. In this embodiment, the outer balloon proximal end connecting portion 92 is sleeved outside the first end of the outer tube 1, and the outer balloon distal end connecting portion 93 is sleeved outside the balloon distal end connecting portion 23.
The outer balloon main body 91 may be an integral structure or a separate structure. In the present embodiment, the case of the split structure is shown. Outer balloon main body 91 includes outer near-end balloon main body 911 and outer far-end balloon main body 912 that the separation set up, and outer near-end balloon main body 911 covers on electrode wire 4 on the surface of balloon main body 21, and the edge of outer near-end balloon main body 911 supports the first end of pressing a plurality of electrode slices 3 on the surface of balloon main body 21, and outer far-end balloon main body 912 edge supports the second end of pressing a plurality of electrode slices 3 on the surface of balloon main body 21 for electrode slices 3 partially expose between outer near-end balloon main body 911 and outer far-end balloon main body 912. Of course, it is also possible to cover only the outer proximal balloon body 911 on the electrode lead 4 on the outer surface of the balloon body 21, so that the electrode tabs 3 are all exposed between the outer proximal balloon body 911 and the outer distal balloon body 912. The exposed electrode slice 3 is used for contacting with the ablation area for ablation.
In the case where the outer balloon main body 91 is of an integral structure, it is only necessary to provide an electrode sheet exposed region, such as a hole, on the outer balloon main body 91, so that the electrode sheet 3 is at least partially exposed out of the outer balloon main body 91.
Fig. 8a and 8b are perspective views of a balloon electrode catheter according to a second embodiment of the present invention before and after pressurization, respectively.
In addition, as shown in fig. 9, the balloon electrode catheter further includes an adjustable bending handle 10, and the adjustable bending handle 10 is provided with an electrode lead interface connected with the electrode lead 4, a gas or liquid injection interface communicated with the outer tube 1, and a guide wire lumen interface communicated with the inner tube 7.
It should be noted that, in the second embodiment of the present invention, the balloon 2 and the outer balloon 9 are both made of insulating materials, so that the electrode lead 4 can be prevented from being broken down; the outer balloon 9 can be made by a film coating process.
In the above, the overall structure of the balloon electrode catheter is described in detail in the first and second embodiments of the present invention, and the ablation effect of the pulmonary veins of the heart is related to the number and size of the electrode pads 3 and the applied ablation voltage.
Typically, 400V/cm is required for field strength for cardiac pulmonary vein formation ablation, and based on simulations, there are regions near the electrodes where field strength is low ("low field strength regions" where field strength is significantly lower than that of the region near the electrodes) and where tissue may not be ablated properly.
The diameter of the balloon 2 is designed according to the size of the pulmonary vein ostium, which has a relatively fixed size, so in the simulation the diameter of the balloon 2 was chosen (in general, but not limited to) to be 23 mm. The electrode plates 3 are rectangular, and for the width of the electrode plates 3, all the electrode plates 3 are required to be capable of passing through the sheath tubes 11 when the saccule 2 is furled, so that the width of the electrode plates 3 can be selected within the width range of 0.5-3 mm, wherein the width is 1.5 mm. The thickness of the electrode sheet 3 may be selected within a range of 100nm to 0.2 mm. The diameter of the outer tube 1 is 9-15 Fr, wherein French (F or Fr) is the diameter unit of a catheter which is commonly used in the field of medical instruments, and 3Fr is approximately equal to 1 mm.
First, the inventors determined the effect of the number of electrode pads 3 on the ablation area.
Since the applied ablation voltage value and the electrode sheet length are also important parameters affecting the ablation effect, the applied ablation voltage value and the electrode sheet length value are preset in order to analyze the influence of the number of the electrode sheets 3 on the ablation region. Since the ablation voltage value applied for electrical ablation is generally 500-3000V, the ablation voltage is set to 2500V, the electrode plate length is set to 5mm, and the number of the electrode plates 3 is 4, 6, 8, 10, 12 respectively, for simulation, see fig. 10. In fig. 10, a denotes the pulmonary vein ostium, B denotes the effective ablation zone, and C denotes the non-ablated region. Also shown in fig. 9 is the ablation width W, i.e., the shortest arc length of the pulmonary vein ablation zone in the axial direction of the vein.
Referring to fig. 11, in fig. 11, (a) shows a case where there are 4 electrode pads, (b) shows a case where there are 6 electrode pads, (c) shows a case where there are 8 electrode pads, (d) shows a case where there are 10 electrode pads, and (e) shows a case where there are 12 electrode pads. In each figure, the central white circular area represents a pulmonary vein blood vessel orifice A, the white parts at the periphery are effective ablation areas B with the field intensity reaching 400V/cm, and the areas with a plurality of black dots at the periphery are non-ablation areas C. It can be seen that when the number of electrode plates is too small (4), the effective ablation area is not uniform enough, and the narrowest part is too narrow; when the number of electrode tabs is too large (12), the entire effective ablation region becomes narrow and discontinuity occurs. Therefore, the number of the electrode pieces is preferably 6 to 10.
The inventor also carries out multiple times of simulation based on different ablation voltages and electrode slice lengths, and the influence of the number of the electrode slices on the ablation effect is similar to the simulation result, so that the number of the electrode slices with 8 electrode slices is determined to be the better number, and how to optimize the electrode slice length is analyzed based on the balloon electrode catheter with 8 electrode slices.
Therefore, the electrode sheet 3 of the embodiment of the invention is rectangular, the long axis of the electrode sheet 3 is arranged along the axial direction of the balloon electrode catheter, and the length L of the electrode sheet 3 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 3.
Through simulation, in fig. 12, given that L is 3mm, 4mm, 5mm, 6mm or 7mm in the case of different electrode sheet lengths L, the relationship between the ablation width W and the ablation voltage V is approximately linear, and therefore the following fitting function can be adopted:
W＝a1(L)V+a2(L) (1)，
wherein, a1(L) and a2(L) represents a function with respect to L.
As shown in fig. 12, since the slopes of the respective straight lines are substantially the same when the electrode sheet lengths L are different, it can be considered that a is1(L) is independent of the value of the electrode sheet length L, i.e. a1(L) is a constant. After adopting the linear fitting simulation, a can be obtained1The value of (L) is 0.002 and Li, a for different electrode sheet lengths2The value of (Li) can also be determined, thus obtaining the parameter a of FIG. 132(Li) vs. electrode sheet length Li. A after simulation2The curve of (L) and L is close to a power function, so fitting with a power function can be written as:
wherein the coefficient b is obtained by calculation1＝-15.4、b2＝-0.79、b3＝6.8。
Substituting the formula (2) into the formula (1),
writing the electrode slice length L into a function of the ablation width W and the ablation voltage V based on the formula (3) to obtain
Further rewriting the formula (4) to obtain
Wherein the content of the first and second substances,
the unit of the length L of the electrode slice is millimeter,
w is a preset shortest ablation width in mm in the axial direction of the pulmonary vein,
v is a voltage applied to the electrode sheet 3 in volts,
c1, c2, c3, c4 are coefficient values at a specific number of electrode tabs.
During calculation, specific numerical values are obtained according to the unit of each parameter and are substituted into the formula (5), and the obtained value is the length value of the electrode plate length L in millimeter unit. Based on the above formula, the length L of the electrode can be flexibly determined according to the ablation width W and the ablation voltage V.
In this embodiment, the width of the electrode sheet is 1.5mm, and the number of the electrode sheets 3 is 8, wherein,
c1＝-6.49x10-2，
c2＝1.30x10-4，
c3＝0.442，
c4＝-1.27。
similarly, based on the embodiments of the present application, a person skilled in the art can know how to calculate the corresponding c1, c2, c3, and c4 under the conditions of different electrode slice widths and different numbers of electrode slices, and find out the corresponding relation L ═ f (W, V), which is not described herein again.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (13)
1. A balloon electrode catheter is characterized by comprising an outer tube, a balloon, an electrode plate and an electrode lead,
a first end of the outer tube is connected to a proximal end portion of the balloon;
the electrode lead is arranged in the outer tube in a penetrating mode;
the electrode plates are even in number, the positive and negative intervals are uniformly arranged on the outer surface of the annular side wall of the balloon at the same height, the long axis of each electrode plate is arranged along the axial direction of the balloon electrode catheter, the electrode plates are respectively connected with respective electrode leads, the length L of each electrode plate is determined based on the preset shortest ablation width W in the axial direction of the pulmonary vein and the ablation voltage V applied to the electrode plate, and the length L of each electrode plate is as follows:
wherein the unit of the length L of the electrode slice is millimeter,
w is a preset shortest ablation width in mm in the axial direction of the pulmonary vein,
v is the ablation voltage applied to the electrode pad, in volts,
c1、c2、c3、c4is the coefficient value at a particular number of electrode slices;
after the saccule is pressurized and expanded, the electrode slice can be attached to the pulmonary vein opening to form an annular ablation band.
2. A balloon electrode catheter as in claim 1 wherein the electrode tabs are rectangular in shape.
3. The balloon electrode catheter as defined in claim 1, wherein the electrode sheet has a width ranging from 0.5 to 3mm, a thickness ranging from 100nm to 0.2mm, the number of the electrode sheets being 6 to 10, and the outer tube having a diameter ranging from 9 to 15 Fr.
4. The balloon electrode catheter of claim 3, wherein the electrode pads are 1.5mm wide and the number of electrode pads is 8,
c1＝-6.49x10-2，
c2＝1.30x10-4，
c3＝0.442，
c4＝-1.27。
5. a balloon electrode catheter as in claim 2 wherein the electrode pads are disposed on a distal hemispheric side of the balloon.
6. A balloon electrode catheter according to claim 2, further comprising an inner tube movably disposed within the lumen of the outer tube, the first end of the inner tube extending from the first end of the outer tube, the distal end of the balloon being secured to the first end of the inner tube.
7. A balloon electrode catheter as in claim 6, wherein the balloon comprises a balloon body and a balloon distal end connecting portion, the balloon distal end connecting portion is in a hollow cylindrical shape, an annular support member is sleeved on the first end of the inner tube, and the balloon distal end connecting portion is fixedly connected to the outer side of the support member.
8. A balloon electrode catheter according to claim 7, wherein the balloon further includes a balloon proximal end connecting portion having a hollow cylindrical shape, and a groove for embedding the electrode wire is provided on an outer surface of the balloon main body and/or on an outer surface of the balloon proximal end connecting portion.
9. The balloon electrode catheter according to claim 8, further comprising an outer balloon attached to an outer side of the balloon, wherein the outer balloon is provided with an electrode pad exposed area corresponding to the electrode pad on the balloon.
10. A balloon electrode catheter according to claim 9, wherein the outer balloon includes an outer balloon main body, an outer balloon proximal end connecting portion and an outer balloon distal end connecting portion, the outer balloon proximal end connecting portion and the outer balloon distal end connecting portion being respectively provided at both ends of the outer balloon main body;
the balloon near-end connecting portion, the outer balloon near-end connecting portion and the first end of the outer tube are fixedly connected, the first end of the inner tube penetrates through the balloon near-end connecting portion and the outer balloon near-end connecting portion, and the balloon far-end connecting portion, the outer balloon far-end connecting portion and the first end of the inner tube are fixedly connected.
11. A balloon electrode catheter as in claim 10, wherein the outer balloon body comprises an outer proximal balloon body and an outer distal balloon body that are separately disposed, and the electrode tabs are at least partially exposed between the outer proximal balloon body and the outer distal balloon body.
12. A balloon electrode catheter as in claim 8, further comprising a cover for securing the electrode wire to an outer surface of the balloon body.
13. A balloon electrode catheter according to claim 6, further comprising an adjustable bending handle, the adjustable bending handle being provided with an electrode lead port connected to the electrode lead, a gas or liquid injection port communicating with the outer tube, and a guide wire lumen port communicating with the inner tube.
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| CN202110163553.9A CN112998844B (en) | 2021-02-05 | 2021-02-05 | Balloon electrode catheter |
| PCT/CN2021/084395 WO2022165962A1 (en) | 2021-02-05 | 2021-03-31 | Balloon electrode catheter |
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| CN202110163553.9A CN112998844B (en) | 2021-02-05 | 2021-02-05 | Balloon electrode catheter |
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| 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 |
| CN117796895A (en) * | 2024-02-29 | 2024-04-02 | 浙江伽奈维医疗科技有限公司 | Steep pulse ablation catheter and equipment |
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| WO2004086993A2 (en) * | 2003-03-28 | 2004-10-14 | C.R. Bard, Inc. | Method and apparatus for adjusting electrode dimensions |
| CN103027750B (en) * | 2012-11-23 | 2015-02-11 | 刘宗军 | Electrical ablation balloon radiofrequency catheter in percutaneous renal artery |
| JP6220044B2 (en) * | 2013-03-15 | 2017-10-25 | ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． | Medical device for renal nerve ablation |
| CN107949336B (en) * | 2015-08-27 | 2021-10-22 | 密涅瓦外科有限公司 | Tissue resection device |
| US11331140B2 (en) * | 2016-05-19 | 2022-05-17 | Aqua Heart, Inc. | Heated vapor ablation systems and methods for treating cardiac conditions |
| CN113015495A (en) * | 2018-09-11 | 2021-06-22 | 阿卡赫特有限公司 | Heating steam ablation system and method for treating heart disease |
| CN109223169A (en) * | 2018-11-13 | 2019-01-18 | 上海安钛克医疗科技有限公司 | Pulmonary vein is electrically isolated balloon structure |
| CN211381733U (en) * | 2019-12-10 | 2020-09-01 | 杭州睿笛生物科技有限公司 | Electric pulse ablation system for treating atrial fibrillation |
| CN111529051B (en) * | 2020-04-16 | 2021-05-07 | 上海睿刀医疗科技有限公司 | System for predicting electric pulse ablation area |
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Address after: 201318, 3 floor, 3 lane, 166 lane, Tian Xiong Road, Pudong New Area, Shanghai. Patentee after: Shanghai RuiDao Medical Technology Co.,Ltd. Address before: 201318, 3 floor, 3 lane, 166 lane, Tian Xiong Road, Pudong New Area, Shanghai. Patentee before: SHANGHAI REMEDICINE Co.,Ltd. |