CN112842518A - Electrode device, ablation catheter and ablation system - Google Patents
Electrode device, ablation catheter and ablation system Download PDFInfo
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- CN112842518A CN112842518A CN202110309621.8A CN202110309621A CN112842518A CN 112842518 A CN112842518 A CN 112842518A CN 202110309621 A CN202110309621 A CN 202110309621A CN 112842518 A CN112842518 A CN 112842518A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- 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
- 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
Abstract
The invention relates to an electrode device, an ablation catheter and an ablation system; the ablation system comprises an energy output device and an ablation catheter, wherein the energy output device is used for selectively delivering ablation energy to the ablation catheter; the ablation catheter comprises a catheter body and a catheter head end, wherein the catheter head end is connected with the far end of the catheter body and comprises an electrode device, the electrode device comprises a first electrode and a second electrode which are axially distributed, the first electrode is positioned at the head end of the electrode device, and the first electrode and the second electrode are connected through an insulating part; the ablation catheter can realize bipolar pulse ablation, unipolar pulse ablation and radio frequency effects, and particularly can be used for pulse ablation of renal arteries, so that the ablation mode is more flexible and convenient.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an electrode device, an ablation catheter and an ablation system.
Background
Hypertension (HTN, an abbreviation for High Twisted neurological) is one of the major risk factors for cardiovascular disease and is a public health problem worldwide. It is estimated that more than 10 million people worldwide suffer from hypertension, which is expected to increase to 15 million by 2025; over 900 million deaths per year are attributed to hypertensive complications such as myocardial infarction, stroke, and renal failure. The existing blood pressure lowering treatment is completely established on the selection and combined use of a plurality of blood pressure lowering medicines, although a plurality of safe and effective blood pressure lowering medicines exist, 10% -15% of patients with hypertension still take 3 or more than 3 blood pressure lowering medicines (including diuretics) with tolerable dose, or take 4 or more than 4 blood pressure lowering medicines, and the patients cannot control the blood pressure within a normal range (below 140/90 mmHg) within a certain time (at least >1 month), so the treatment is called intractable hypertension. Studies have shown that a 20mmHg rise in Systolic Blood Pressure (SBP) doubles the mortality rate from heart disease and stroke; in contrast, a 10mmHg decrease may reduce stroke rate by 41%.
Renal artery sympathetic nerve activation is an important factor in the development and progression of hypertension, and numerous animal experiments have demonstrated the effect of the sympathetic nervous system on blood pressure. Renal artery denervation (RDN) is a new interventional treatment technique that has emerged in the last decade, and can remove sympathetic nerves innervating the kidney by radio frequency ablation or cryoablation, i.e. by femoral artery puncture and angiography, introducing a special radio frequency ablation catheter or cryoablation catheter into the renal artery, and emitting radio frequency energy or cryoenergy to destroy the sympathetic nerves innervating the kidney, i.e. to treat hypertension by blocking the renal artery sympathetic afferent and efferent nerve fibers, thereby significantly reducing the blood pressure of patients with refractory hypertension. Renal artery denervation (RDN) has shown good application prospects in clinical trials of refractory hypertension.
Currently, the clinical trials of renal artery denervation (RDN) employ radiofrequency ablation (RF) and cryoablation, which achieve ablation effects in the form of heat and cryogenic temperature release, respectively, but have certain limitations, such as lack of selectivity for tissue destruction in the ablation region, possible damage to adjacent tissues, and in addition, RF ablation requires a high catheter and tissue apposition. Recently, the emerging pulse ablation (PFA) selectively ablates cells by releasing pulsed electric field energy to form nano-scale pores in cell membranes, resulting in apoptosis, has the advantage of damaging cells without heating, and has cell/tissue selectivity to protect surrounding critical tissue structures. However, the same set of ablation catheter cannot be compatible with various ablation modes, the catheter needs to be frequently replaced in the ablation process, the operation time is increased, and risks in the operation process are increased.
Disclosure of Invention
In order to solve the technical problems, the invention aims to provide an electrode device, an ablation catheter and an ablation system, aiming at enabling the same set of ablation catheter to be compatible with pulse ablation and radio frequency ablation through a double-electrode structure, and enabling the ablation catheter to be also used for renal artery pulse ablation to achieve the purpose of treating hypertension, so that the use flexibility of the same set of ablation catheter is improved, the operation time is shortened, and the risk in the operation process is reduced.
In order to achieve the above object, according to a first aspect of the present invention, there is provided an electrode device, comprising a first electrode and a second electrode distributed axially, wherein the first electrode is located at a head end of the electrode device, and the first electrode and the second electrode are connected through an insulating member.
Preferably, the insulation distance between the first electrode and the second electrode is 0.15mm to 1.5 mm.
Preferably, the axial length of the first electrode is less than the axial length of the second electrode.
Preferably, the axial length of the first electrode is 0.1mm to 1.5mm, the sum of the axial length of the second electrode and the axial length of the first electrode is 3.0mm to 4.5mm, and the axial distance from the distal end face of the second electrode to the distal end face of the first electrode is 0.25mm to 3.0 mm.
Preferably, the electrode device further comprises a hollow tube, and the distal end of the hollow tube is connected with the first electrode and is coaxially arranged; the outer diameter of the hollow tube is smaller than that of the first electrode; the insulating part comprises a first insulating part, the first insulating part is sleeved on the hollow tube, and the far end of the second electrode is sleeved on the first insulating part.
Preferably, the first insulating member includes a distal end portion and a proximal end portion connected to each other, an outer diameter of the proximal end portion is smaller than an outer diameter of the distal end portion, a distal end of the second electrode is fitted over the proximal end portion, and a distal end surface of the distal end portion is connected to the first electrode; the distal portion has an outer diameter that is the same as an outer diameter of the first electrode, and the second electrode has a distal outer diameter that is the same as an outer diameter of a proximal face of the distal portion.
Preferably, the hollow tube has a fluid conveying channel, the first electrode is provided with a first perfusion hole, the hollow tube is provided with a second perfusion hole, the second electrode is provided with a third perfusion hole, the first perfusion hole and the second perfusion hole are both communicated with the fluid conveying channel, and the third perfusion hole is communicated with the second perfusion hole.
Preferably, temperature sensors are arranged inside the first electrode and the second electrode; the first electrode, the first insulating part and the second electrode are all provided with first wire holes, the side wall of the hollow tube is internally provided with a second wire hole, and the side wall of the second electrode is internally provided with an axial through hole; a lead of the temperature sensor of the first electrode sequentially passes through a first lead hole of the first electrode, a first lead hole of the first insulating part and a first lead hole of the second electrode; the lead of the first electrode passes through the second lead hole; at least one of a lead wire of the temperature sensor of the second electrode and a lead wire of the second electrode passes through the axial through hole.
Preferably, the electrode device further comprises a magnetic positioning sensor for positioning the position of the electrode device; the magnetic positioning sensor is of a tubular structure and is sleeved on the hollow tube; the magnetic locator sensor is disposed between the hollow tube and the second electrode, and the magnetic locator sensor is configured to expose at least a portion of the second irrigation hole on the hollow tube.
Preferably, the insulator includes a second insulator, and the first electrode and the second electrode are respectively screwed to the second insulator.
Preferably, the proximal end of the first electrode is provided with an internal threaded hole, the second insulating part is provided with a step surface at the distal end and an internal threaded hole at the proximal end, the step surface is provided with an external thread, and the distal end of the second electrode is provided with an external thread head; the external thread of the step surface is in threaded connection with the internal thread hole of the first electrode, and the external thread head of the second electrode is in threaded connection with the internal thread hole of the second insulating part.
Preferably, the distal end surface of the electrode device is an arc surface, and the arc angle of the arc surface is less than or equal to 90 °.
Preferably, the arc angle of the arc surface is greater than or equal to 5 °.
In order to achieve the above object, according to a second aspect of the present invention, there is provided an ablation catheter comprising a catheter body and a catheter tip, the catheter tip being connected to a distal end of the catheter body, the catheter tip comprising any one of the electrode arrangements.
Preferably, the electrode device has a fluid delivery channel; the ablation catheter further comprises a fluid delivery tube, the fluid delivery channel being in communication with the fluid delivery tube; wherein: and the first electrode and/or the second electrode are/is provided with perfusion holes, and the perfusion holes are in fluid communication with the fluid conveying channel.
Preferably, the catheter tip further comprises at least one ring electrode, the at least one ring electrode is sleeved on the distal end of the catheter body, and a preset distance is kept between the at least one ring electrode and the second electrode.
To achieve the above object, according to a third aspect of the present invention, there is provided an ablation system comprising an energy output device and any one of the ablation catheters, wherein the energy output device is used for selectively delivering ablation energy to the ablation catheter, and the ablation energy comprises pulse ablation and/or radio frequency ablation energy.
Preferably, the energy output device is used for simultaneously delivering electric pulses to the first electrode and the second electrode and forming monopolar or bipolar pulse ablation, or the energy output device is used for delivering radio-frequency current to at least one of the first electrode and the second electrode for radio-frequency ablation; alternatively, the energy output device is configured to selectively deliver electrical pulses to the first and second electrodes or radio frequency current to at least one of the first and second electrodes to cause alternating pulse ablation and radio frequency ablation.
In the electrode device, the ablation catheter and the ablation system provided by the invention, bipolar pulse discharge can be realized by arranging the two electrodes in front and back, and the ablation catheter can be used for renal artery ablation, so that sympathetic afferent and efferent nerve fibers of the renal artery can be completely blocked by ablation, and the aim of treating hypertension is fulfilled. Of course, the ablation catheter of the present application may also be used for other site ablation (e.g., cardiac ablation, bronchial ablation, etc.) or ablation of other conditions, which is not limited by the present application.
In the electrode device, the ablation catheter and the ablation system provided by the invention, radio frequency ablation can be selected, pulse ablation can be selected, or the radio frequency ablation and the pulse ablation are alternately carried out, and in the ablation process, an operator can select a more appropriate energy mode to carry out ablation according to the complexity of a surgical part, the actual condition of a patient or the experience of a doctor, so that more accurate and comprehensive ablation can be realized, the complexity of the operation is greatly reduced, the operability of the operation is enhanced, the operation time is shortened, and the risk in the operation process is reduced.
In the electrode device, the ablation catheter and the ablation system provided by the invention, the two electrodes are axially distributed, and further, the two electrodes are simultaneously attached to tissues to perform pulse ablation as far as possible through the structural design of the axial dimension of the electrodes, so that the ablation effect is better, and the ablation efficiency is higher.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic view of the overall construction of an ablation catheter in a preferred embodiment of the invention;
FIG. 2a is an enlarged schematic view of the catheter tip of an ablation catheter in a preferred embodiment of the invention;
FIG. 2b is a cross-sectional view of the catheter tip of FIG. 2a taken along line A-A;
FIG. 3a-1 is a schematic diagram of the connection of a first electrode to a hollow tube in a preferred embodiment of the invention;
FIG. 3a-2 is an exploded view of the second electrode and insulator in a preferred embodiment of the invention;
FIG. 3b is a three-dimensional perspective view of a catheter tip in a preferred embodiment of the invention;
FIG. 4 is a schematic view of an ablation catheter in a preferred embodiment of the invention as ablation is performed within a renal artery;
FIG. 5 is a schematic diagram of the pulsed electric field when the ablation catheter is in contact with tissue in a preferred embodiment of the invention;
FIG. 6a is a schematic structural view of a catheter tip in accordance with another preferred embodiment of the present invention;
fig. 6B is a cross-sectional view of the catheter tip of fig. 6a taken along line B-B.
The reference numerals are explained below:
1-a first electrode; 1-1-a first infusion well; 1-2-a second infusion well; 1-3-a first wire guide; 1-4-a second wire guide; 2-a second electrode; 2-1-a third infusion well; 2-2-axial through hole; 3-a first insulator; 31-a distal portion; 32-a proximal end portion; 3' -a second insulator; a 4-ring electrode; 5-a pipe body; 6-handle knob; 7-a handle; 8-pulse energy interface; 9-radio frequency energy interface; 10-a fluidic interface; 12-a hollow tube; 13-a proximal section; 14-a magnetic positioning sensor; 15-catheter tip; 16-lead of thermocouple; 17-a lead of the second electrode; 18-a lead of the first electrode; 19-a fluid delivery tube; s1-renal artery blood vessel; s2-organization.
Detailed Description
In order to make the content of the present invention more comprehensible, the present invention is further described with reference to the accompanying drawings. The invention is of course not limited to this particular embodiment, and general alternatives known to those skilled in the art are also covered by the scope of the invention. The present invention is described in detail with reference to the drawings, but these drawings are only for convenience of describing the present invention in detail and should not be construed as limiting the present invention.
Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.
Herein, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the product, although "proximal" and "distal" are not limiting, but "proximal" generally refers to the end of the product that is closer to the physician during normal operation, while "distal" and "head end" generally refer to the end that is first introduced into the patient. As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. Furthermore, the terms "first", "second", "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", "third" may explicitly or implicitly include one or at least two of the features. Additionally, the term "circumferential" generally refers to a direction about the axis of the ablation catheter; the term "longitudinal" generally refers to a direction parallel to the axis of the ablation catheter; the term "transverse" generally refers to a direction perpendicular to the axis of the ablation catheter.
The electrode device, the ablation catheter and the ablation system according to the present invention will be further described with reference to the accompanying drawings and preferred embodiments.
Referring to fig. 1 and 2a, the present embodiment provides an ablation catheter, which includes a tube 5 and a catheter tip 15, wherein the catheter tip 15 is connected to a distal end of the tube 5, and the catheter tip 15 is used to apply ablation or signal extraction to tissue. The catheter tip 15 comprises an electrode arrangement comprising two axially distributed first and second electrodes 1, 2. The first electrode 1 is located at the head end of the electrode arrangement. The joint of the first electrode 1 and the second electrode 2 is provided with a first insulating member 3, and the first insulating member 3 is used for connecting the two electrodes and electrically isolating the two electrodes. The present invention does not require the material of the first insulating member 3, and for example, the material of the first insulating member 3 may be a liquid crystal polymer material or other electrically insulating material.
In this embodiment, the two electrodes may extract signals for performing the electrical potential mapping, select two electrodes with opposite polarities as the case may be to implement the bipolar discharge pulse ablation, select two electrodes with the same polarity as the case may be to implement the unipolar discharge pulse ablation, and select at least one electrode as the case may be to implement the rf discharge ablation. By the structure, bipolar discharge pulse ablation can be realized through the two electrodes, and a better ablation effect is achieved. It is understood that the pulse ablation can selectively damage cells without heating, form nano-scale pores on cell membranes to cause apoptosis, have the advantages of no thermal effect and cell/tissue selectivity, protect surrounding key tissue structures, reduce the operation time and reduce the time of the doctor and the patient affected by rays, and therefore, the pulse ablation is safer and more reliable.
In the embodiment, the ablation catheter can independently perform radio frequency ablation, pulse ablation and switching back and forth between the pulse ablation and the radio frequency ablation, so that an operator can select a more appropriate energy mode to perform ablation according to the complexity of a surgical part, the actual condition of a patient or the experience of a doctor in the ablation process, thereby achieving more accurate and comprehensive ablation, greatly reducing the complexity of the operation, enhancing the operability of the operation, shortening the operation time and reducing the risk in the operation process.
In the embodiment, the two electrodes arranged in front and back can be better attached to the tissue, the two electrodes are enabled to be attached to the tissue for ablation at the same time in the ablation process, the ablation effect is good, the ablation efficiency is high, particularly, due to the electrode structure, the ablation catheter can be used for renal artery ablation, so that sympathetic afferent and efferent nerve fibers of the renal artery can be completely blocked through ablation, the purpose of treating hypertension is achieved, the use flexibility of the ablation catheter is improved, and the application scene is wider. Of course, the ablation catheter of the present invention may also be used for ablation of pulmonary veins of the heart, bronchial ablation, or other sites, and the present application is not limited thereto. Especially when bipolar pulse ablation is performed, muscle stimulation during ablation can be reduced, and the efficiency and safety of ablation can be improved compared with unipolar pulse ablation.
Further, the insulation distance between the first electrode 1 and the second electrode 2 is preferably 0.15mm to 1.5mm, that is, in the present embodiment, the insulation distance is also the thickness of the portion of the first insulating member 3 between the first electrode 1 and the second electrode 2. It should be understood that when the pulse ablation is performed, since the pulse electric field is released between the two electrodes as the positive and negative electrode signals, if the distance between the electrodes is too small, the spark phenomenon and the low temperature plasma effect are easily generated, and if the distance between the electrodes is too long, the electric field strength is affected. Therefore, the insulation distance between the two electrodes is designed to be 0.15-1.5 mm, the insulation distance can ensure the energy intensity of an electric field and does not generate ionization, and the two electrodes (namely 1 and 2) can be ensured to contact tissues at the same time to the maximum extent, so that the effective electric field coverage of a focus is increased, and the ablation effect and the ablation efficiency are further improved.
Referring to fig. 2b and 3b, the ablation catheter further includes a fluid delivery tube 19 for delivering saline to the catheter tip 15, so as to facilitate the infusion of saline for cooling during rf ablation, thereby avoiding excessive temperature. It is understood that other cooling media besides saline may be used for radiofrequency ablation perfusion cooling. While the electrode device has a fluid delivery channel communicating with the fluid delivery tube 19. Further, the first electrode 1 and/or the second electrode 2 are/is provided with perfusion holes, and the perfusion holes are in fluid communication with the fluid conveying channel.
Referring to fig. 3a-1 and 2b, in some embodiments, the electrode assembly further comprises a hollow tube 12; the far end of the hollow tube 12 is fixedly connected with the first electrode 1 and coaxially arranged; on the one hand, the hollow tube 12 is convenient to construct a fluid conveying channel, on the other hand, the hollow tube 12 is convenient to tightly connect the first insulating part 3 and the two electrodes, the connection stability and reliability are ensured, and the problems that the two electrodes fall off or are loosened and the like are effectively avoided.
Preferably, the first electrode 1 is provided with first perfusion holes 1-1, for example 6 first perfusion holes 1-1, the first perfusion holes 1-1 are distributed along the circumference of the first electrode 1, preferably uniformly distributed, and the first perfusion holes 1-1 are in fluid communication with the inner cavity (i.e. fluid conveying channel) of the hollow tube 12. Furthermore, the hollow tube 12 is provided with a second perfusion opening 1-2, for example 3-4 second perfusion openings 1-2, in a position close to the first electrode 1, the second perfusion openings 1-2 are distributed, preferably evenly distributed, in the circumferential direction and/or in the axial direction of the hollow tube 12, the second perfusion openings 1-2 are also in fluid communication with the inner cavity of the hollow tube 12, and the second perfusion openings 1-2 are in fluid communication with the interior of the second electrode 2. Further, the second electrode 2 is provided with a plurality of third perfusion holes 2-1, the third perfusion holes 2-1 are preferably a plurality of third perfusion holes, and the plurality of third perfusion holes 2-1 are distributed along the circumferential direction and/or the axial direction of the second electrode 2, preferably uniformly distributed. The third perfusion hole 2-1 is in fluid communication with the inside of the second electrode 2, and the second perfusion hole 1-2 is also in fluid communication with the inside of the second electrode 2, so that a cooling medium such as physiological saline can flow into the inside of the second electrode 2 through the second perfusion hole 1-2 and then be released through the third perfusion hole 2-1. Further, the fluid delivery tube 19 is disposed within the hollow tube 12 and may be adhesively secured using glue, or otherwise secured.
Referring back to fig. 1, the proximal end of the tube 5 is typically provided with a handle assembly for controlling the surgical operation on the entire catheter. Further, a portion of the fluid delivery tube 19 extends through the hollow tube 12 and another portion extends through the body 5 and the handle assembly, where it is connected to the fluid port 10 at the proximal end of the handle assembly. The fluid interface 10 is used for connecting a perfusion apparatus for perfusion of a liquid such as saline.
Referring to fig. 2b and fig. 3b, in a preferred embodiment, the first insulating member 3 and the second electrode 2 are sequentially assembled outside the hollow tube 12, that is, the first insulating member 3 is sleeved on the hollow tube 12, and the distal end of the second electrode 2 is sleeved on the first insulating member 3. Wherein the distal end of the first insulating member 3 and the proximal end of the first electrode 1 can be connected by gluing or snapping, etc. so that they are firmly connected to each other. The distal end of the second electrode 2 may also be fixedly connected to the first insulator 3 by glue or other means.
Referring to fig. 3a-2 in combination with fig. 2b, the first insulating member 3 preferably includes a distal portion 31 and a proximal portion 32 connected to each other, the outer diameter of the proximal portion 32 is smaller than that of the distal portion 31, the second electrode 2 is disposed on the proximal portion 32, and the distal surface of the distal portion 31 is fixedly connected to the first electrode 1. More preferably, the outer diameter of the distal end portion 31 of the first insulator 3 is the same as the outer diameter of the first electrode 1, which ensures smooth transition to form a smooth surface after assembly. Preferably, the outer diameter of the distal end of the second electrode 2 is the same as the outer diameter of the proximal end face of the distal end portion 31, so as to ensure that the two are smooth in transition after being assembled and form a smooth surface. By the sizing of the distal end portion 31 and the provision of the proximal end portion 32, the contact area of the first insulator 3 with the second electrode 2 is increased, thereby increasing the connection stability of the first insulator 3 with the second electrode 2. Further, the contact surfaces of the first insulating part 3, the first electrode 1 and the second electrode 2 can be polished in advance to increase friction force, so that the three parts are connected more firmly.
Preferably, the second electrode 2 comprises a distal section (not labeled) and a proximal section 13 (see fig. 3a-2, 3b) connected, the outer diameter of the proximal section 13 being smaller than the outer diameter of the distal section, and the outer diameter of the proximal section 13 being smaller than the inner diameter of the tube 5, so that the proximal section 13 is assembled with the distal end of the tube 5, with the distal end of the tube 5 being fitted over the proximal section 13. Preferably, the outer diameter of the distal end of the tube 5 is the same as the outer diameter of the proximal end face of the distal section of the second electrode 2, again to ensure that the two transition is smooth after assembly to form a smooth surface. The outer diameter of the distal section is not limited by the present application, and for example, the distal section in fig. 2b is a cylindrical structure with the same outer diameter, and for example, the distal end of the distal section in fig. 6b is provided with an external thread head, or other suitable structures.
Further, the catheter tip 15 also comprises a magnetic positioning sensor 14 for positioning the catheter tip 15 and the electrode arrangement. As shown in fig. 2b, a hollow magnetic position sensor 14 is disposed in the second electrode 2, the magnetic position sensor 14 is sleeved on the hollow tube 12, and the magnetic position sensor 14 is disposed between the hollow tube 12 and the second electrode 2. The magnetic positioning sensor 14 may be fixed using glue. Further, the magnetic position sensor 14 is configured to expose at least a portion of the second infusion port 1-2 on the hollow tube 12 to prevent the magnetic position sensor 14 from occluding the second infusion port 1-2.
Referring to fig. 2a and 2b, at least one ring electrode 4 is preferably disposed at the distal end of the tube body 5 for extracting signals and facilitating mapping of electric potential. The ring electrode 4 is spaced from the proximal end of the second electrode 2 by a distance to provide electrical isolation, the ring electrode 4 preferably being between 1.0mm and 5mm, more preferably 2mm, from the proximal end face of the second electrode 2. Here, it is understood that the proximal end face of the second electrode 2 refers to the distal end face of the proximal section 13.
Referring back to fig. 1, the handle assembly may include a handle knob 6 and a handle 7, the handle knob 6 being disposed at the proximal end of the tube body 5, the handle knob 6 being connected to the handle 7 at the proximal end, the handle 7 being provided with a pulse energy interface 8 and a radio frequency energy interface 9 at the proximal end. The handle knob 6 is used to control the position and orientation of the catheter tip 15. Further, the first electrode 1 and the second electrode 2 are connected to the pulse energy interface 8 through wires and also connected to the rf energy interface 9 through wires. The pulse energy interface 8 is used for connecting a pulse generator to realize pulse energy ablation. The radio frequency energy interface 9 is used for connecting a radio frequency instrument to realize radio frequency energy ablation. The pulse energy interface 8 and the radio frequency energy interface 9 can be used independently respectively to realize independent bipolar pulse energy ablation and independent radio frequency energy ablation. The pulse energy interface 8 and the radio frequency energy interface 9 can also be used simultaneously to switch between ablation modes by switching between pulse energy and radio frequency energy. In other embodiments, the pulse energy interface 8 and the rf energy interface 9 can be combined into one interface, and the user can connect to the rf instrument or the pulse generator or the rf pulse integrated instrument according to the requirement, and the user can selectively use the pulse ablation or the rf pulse alternate ablation, which is not limited in this application. Furthermore, the proximal end of the handle 7 is further provided with a signal interface (not shown in the figure), and the signal interface can instantly reflect the performance of the catheter (including information such as temperature, pressure, electrocardiosignal and the like) through a signal display instrument, which is not limited in this respect. Further, the axial length of the first electrode 1 is smaller than the axial length of the second electrode 2; as shown in fig. 2a, the axial length L1 of the first electrode 1 is preferably 0.1mm to 1.5mm, the axial length of the second electrode 2 is L2, and the sum of L1 and L2 is preferably 3.0mm to 4.5 mm; thereby ensuring that both electrodes can contact tissue simultaneously. Further, the axial distance from the distal end face of the second electrode 2 to the distal end face of the first electrode 1 is preferably 0.25mm to 3.0 mm; by the structure, the two electrodes can be further ensured to be in good contact with the tissue, signals can be acquired, the two electrodes can be attached to the tissue at the same time, and bipolar discharge is facilitated. Preferably, the tip of the first electrode 1 has a rounded design to prevent tip discharge while maintaining contact between the first electrode 1 and the tissue with a greater tendency for the side wall of the catheter tip 15 to contact, so that the site to be ablated maximally contacts both electrodes. Further, in this embodiment, the first electrode 1 is configured as a head electrode, the second electrode 2 is configured as a ring electrode, and the first electrode 1 is configured as a head electrode with a smaller axial length, which is more beneficial to the acquisition of the electrocardiographic signal on the one hand, and is more beneficial to the simultaneous attachment of the two electrodes to the tissue when the tip of the catheter contacts the tissue on the other hand, which is beneficial to the bipolar discharge. In a preferred embodiment, temperature sensors can be further arranged in the first electrode 1 and the second electrode 2, and are used for measuring the temperature of the two electrodes during ablation so as to avoid burning the tissue due to overhigh temperature. The temperature sensor is preferably a thermocouple.
As shown in fig. 3a-1, a thermocouple is disposed inside the first electrode 1, and a first wire guide 1-3 is disposed on the first electrode 1, and the thermocouple may be fixed in the first wire guide 1-3 of the first electrode 1 by gluing or other fixing means. As shown in fig. 3a-2 and 3b, the lead 16 of the thermocouple on the first electrode 1 sequentially passes through the first electrode 1, the first insulating member 3, the second electrode 2, and further passes through the tube 5, and then is connected to the signal interface at the proximal end of the handle 7. Furthermore, a first wire hole 1-3 is formed in the first insulating member 3, and a first wire hole 1-3 is also formed in the second electrode 2, so that a wire 16 of the thermocouple in the first electrode 1 penetrates through the first wire hole 1-3 of the first insulating member 3 and the first wire hole 1-3 of the second electrode 2 in sequence after penetrating through the first wire hole 1-3 of the first electrode 1, and then enters the tube body 5.
As shown in fig. 3a-1 in combination with fig. 3b, the side wall of the hollow tube 12 is provided with a second wire guide hole 1-4 extending axially, the second wire guide hole 1-4 being used for passing a wire 18 of the first electrode 1. As shown in fig. 3a-2, and in conjunction with fig. 3b, an axial through hole 2-2 is provided in the sidewall of the second electrode 2, and at least one of the thermocouple wire of the second electrode 2 and the wire 17 of the second electrode passes through the axial through hole 2-2. The leads of the two electrodes and the lead of the thermocouple are connected with corresponding interfaces at the near end of the catheter after penetrating through the catheter body 5. This arrangement can protect the wires from the internal fluid to the maximum extent, so that the wires are all arranged around the fluid delivery tube 19 and independently of each other, thereby effectively avoiding problems such as wire breakage or poor conduction.
Referring to fig. 4, the ablation catheter can perform ablation in the renal artery blood vessel S1, and release ablation energy through the catheter tip 15 can completely block sympathetic afferent and efferent nerve fibers of the renal artery, thereby achieving the purpose of treating hypertension. Without being limited thereto, the ablation catheter can also be used for ablation of pulmonary veins of the heart and can also be applied to ablation of other parts.
With further reference to fig. 5, when the catheter tip 15 contacts the tissue S2 and then performs pulsed electric field ablation, the first electrode 1 and the second electrode 2 are respectively electrodes with opposite polarities to generate a pulsed electric field, and the two electrodes simultaneously abut against the tissue S2 to perform pulsed ablation, so that the ablation effect is good and the ablation efficiency is high. Therefore, the ablation catheter provided by the invention can improve the ablation effect and improve the ablation efficiency.
Furthermore, the far end face of the catheter head end 15 is designed to be a large arc, so that the arc discharge of a tip in the ablation process is avoided, and the smooth arc transition of a junction surface attached to the tissue is ensured, so that the catheter head end 15 and the tissue tend to be in inclined contact, two electrodes are attached to the tissue at the same time, and bipolar discharge is facilitated. Further, the arc angle of the arc surface of the distal end surface of the catheter tip 15 is preferably 90 ° or less, that is, the center of the circle is disposed on the central axis of the electrode, and the angle formed by the center of the circle and the two ends of the arc is preferably 90 ° or less, and more preferably 5 ° or more.
In another embodiment, referring to fig. 6a and 6b, the first electrode 1 is screwed to the second insulator 3 ', and the second insulator 3' is also screwed to the second electrode 2. The threaded connection increases the connection stability of the two electrodes and the insulating part, and effectively prevents the electrodes from falling off and the like. In this embodiment, a second perfusion orifice 2-1 is provided in the second electrode 2, and the lumen of the second electrode 2 serves as a fluid delivery channel, and a fluid delivery tube 19 is inserted directly into the second electrode 2 or into the magnetic position sensor 14. In a preferred embodiment, the proximal end of the first electrode 1 is provided with an internal threaded hole, the second insulating member 3 'is provided with a distal step surface and a proximal internal threaded hole, the step surface is provided with an external thread, the distal end of the second electrode 2 is provided with an external thread head, so that the external thread of the step surface is in threaded connection with the internal threaded hole of the first electrode 1, the external thread head of the second electrode 2 is in threaded connection with the internal threaded hole of the second insulating member 3', in addition, the whole electrode device is configured to have a uniform external diameter, the external surface of the whole electrode device is smooth to avoid tissue damage, further, the distal end surface of the whole electrode device is subjected to a large arc design, thereby not only avoiding tip arc discharge in the ablation process, but also ensuring smooth arc transition of a junction surface attached to the tissue, so that the catheter head end 15 is inclined to contact with the tissue, and being more beneficial to the two electrodes to be attached, facilitating bipolar discharge.
Further, embodiments of the present invention also provide an ablation system including the ablation catheter and an energy output device for selectively outputting ablation energy to the ablation catheter, the ablation energy including pulsed ablation and/or radiofrequency ablation energy. In some embodiments, the energy output device is a radiofrequency meter that delivers high frequency electrical current to the ablation catheter through the radiofrequency energy interface 9. In some embodiments, the energy output device is a pulse generator that delivers a pulsed current to the ablation catheter through the pulsed energy interface 8, effecting pulsed field ablation. In practical applications, the pulse generator may be selected to: the electrical pulses are delivered simultaneously to the first electrode 1 and the second electrode 2 and a monopolar pulse ablation is formed, in which case the polarity of both electrodes is the same, or the electrical pulses are delivered simultaneously to the first electrode 1 and the second electrode 2 and a bipolar pulse ablation is formed, with the polarity of both electrodes being opposite. A radiofrequency meter may also be selected to deliver radiofrequency current to at least one of the first electrode 1 and the second electrode 2 for radiofrequency ablation. Alternatively, the energy output device is adapted to selectively deliver electrical pulses to the first and second electrodes 1, 2 or radio frequency current to at least one of the first and second electrodes 1, 2 to cause the alternation of pulse ablation and radio frequency ablation. Further preferably, the ablation system further comprises a control device, the control device is configured to control a connection state of the ablation catheter and the energy output device, so as to control an ablation mode (including rf ablation, unipolar pulse ablation, and bipolar pulse ablation), and in other embodiments, the energy output device integrates functions of an rf instrument and a pulse generator, and the ablation mode is controlled by the control device, which is not limited in this application. In addition, the control device can adopt the existing PLC controller, single chip microcomputer, microprocessor and the like, and a person skilled in the art can know how to select the control device based on the disclosure of the application and the common general knowledge in the field.
In conclusion, according to the technical scheme provided by the embodiment of the invention, after the ablation catheter is used, an operator can select a proper energy mode for ablation according to the complexity of a surgical part, the actual condition of a patient or the experience of a doctor, so that more accurate and comprehensive ablation is achieved, the complexity of the operation is greatly reduced, the operability of the operation is enhanced, the operation time is shortened, and the risk in the operation process is reduced. The ablation catheter has good adhesion with tissues, the two electrodes can be adhered to the tissues for ablation at the same time, the ablation effect is good, the ablation efficiency is high, particularly, the ablation catheter can be used for renal artery ablation, cardiac pulmonary vein ablation and other parts, the application scene is wider, and the use is more flexible and convenient. In addition, the invention realizes that the pulse ablation and the radio frequency ablation are integrated in the same catheter, and cold saline water perfusion can be realized during the radio frequency ablation, thereby further ensuring the safety and the reliability of the ablation. In addition, when the ablation catheter is used for renal artery ablation, sympathetic afferent and efferent nerve fibers of the renal artery can be completely blocked through pulse ablation, so that the aim of treating hypertension is fulfilled, and the treatment effect is better. And two electrodes are axially distributed, and particularly through the structural design of the axial size of the electrodes, the two electrodes are simultaneously attached to tissues as much as possible for pulse ablation, the ablation effect is better, and the ablation efficiency is higher.
It should be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way and substantially, and that the innovations of the present invention, while originating from the field of ablation catheters and their ablation techniques, one skilled in the art will appreciate that the electrode devices of the present invention may also be applied to mapping catheter techniques. It should also be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way and in any way, and that the innovations of the present invention, although derived from renal ablation, will be appreciated by those skilled in the art that the present invention may also be applied to ablation of different sites, such as cardiac ablation, bronchial ablation, etc., and that the present invention is not so limited.
It should be noted that, for a person skilled in the art, several modifications and additions can be made without departing from the method of the invention, which should also be considered as a protection scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.
Claims (18)
1. An electrode device, characterized by comprising a first electrode and a second electrode which are distributed axially, wherein the first electrode is positioned at the head end of the electrode device, and the first electrode and the second electrode are connected through an insulating part.
2. The electrode device of claim 1, wherein the insulation distance between the first electrode and the second electrode is 0.15mm to 1.5 mm.
3. The electrode device of claim 1, wherein an axial length of the first electrode is less than an axial length of the second electrode.
4. The electrode assembly of claim 3 wherein the first electrode has an axial length of 0.1mm to 1.5mm, the sum of the axial length of the second electrode and the axial length of the first electrode is 3.0mm to 4.5mm, and the axial distance from the distal end face of the second electrode to the distal end face of the first electrode is 0.25mm to 3.0 mm.
5. The electrode device of claim 1, further comprising a hollow tube having a distal end connected to and coaxially disposed with the first electrode; the outer diameter of the hollow tube is smaller than that of the first electrode; the insulating part comprises a first insulating part, the first insulating part is sleeved on the hollow tube, and the far end of the second electrode is sleeved on the first insulating part.
6. The electrode assembly of claim 5 wherein said first insulator includes a distal portion and a proximal portion connected together, said proximal portion having an outer diameter less than an outer diameter of said distal portion, said second electrode having a distal end thereof disposed over said proximal portion, said distal end of said distal portion having a distal face connected to said first electrode; the distal portion has an outer diameter that is the same as an outer diameter of the first electrode, and the second electrode has a distal outer diameter that is the same as an outer diameter of a proximal face of the distal portion.
7. The electrode assembly of claim 5 or 6 wherein the hollow tube has a fluid delivery channel, the first electrode has a first infusion port disposed thereon, the hollow tube has a second infusion port disposed thereon, the second electrode has a third infusion port disposed thereon, the first and second infusion ports are both in fluid communication with the fluid delivery channel, and the third infusion port is in fluid communication with the second infusion port.
8. The electrode device according to claim 5 or 6, wherein a temperature sensor is provided inside the first electrode and the second electrode; the first electrode, the first insulating part and the second electrode are all provided with first wire holes, the side wall of the hollow tube is internally provided with a second wire hole, and the side wall of the second electrode is internally provided with an axial through hole; a lead of the temperature sensor of the first electrode sequentially passes through a first lead hole of the first electrode, a first lead hole of the first insulating part and a first lead hole of the second electrode; the lead of the first electrode passes through the second lead hole; at least one of a lead wire of the temperature sensor of the second electrode and a lead wire of the second electrode passes through the axial through hole.
9. The electrode device of claim 7, further comprising a magnetic positioning sensor for positioning the position of the electrode device; the magnetic positioning sensor is of a tubular structure and is sleeved on the hollow tube; the magnetic locator sensor is disposed between the hollow tube and the second electrode, and the magnetic locator sensor is configured to expose at least a portion of the second irrigation hole on the hollow tube.
10. The electrode assembly of claim 1, wherein the insulator includes a second insulator, and the first electrode and the second electrode are each threadably coupled to the second insulator.
11. The electrode assembly of claim 10 wherein the proximal end of the first electrode is provided with an internally threaded bore, the second insulator has a distal stepped surface with external threads and a proximal internally threaded bore, the distal end of the second electrode has an externally threaded head; the external thread of the step surface is in threaded connection with the internal thread hole of the first electrode, and the external thread head of the second electrode is in threaded connection with the internal thread hole of the second insulating part.
12. The electrode device of claim 1, wherein the distal end surface of the electrode device is a circular arc surface having a circular arc angle of 90 ° or less.
13. The electrode device of claim 12, wherein the arc surface has an arc angle of greater than or equal to 5 °.
14. An ablation catheter comprising a catheter body and a catheter tip, the catheter tip being attached to a distal end of the catheter body, the catheter tip comprising an electrode assembly according to any one of claims 1 to 13.
15. The ablation catheter of claim 14, wherein the electrode device has a fluid delivery channel; the ablation catheter further comprises a fluid delivery tube, the fluid delivery channel being in communication with the fluid delivery tube; wherein: and the first electrode and/or the second electrode are/is provided with perfusion holes, and the perfusion holes are in fluid communication with the fluid conveying channel.
16. The ablation catheter of claim 14, wherein said catheter tip further comprises at least one ring electrode, said at least one ring electrode disposed about said distal end of said body, said at least one ring electrode being spaced a predetermined distance from said second electrode.
17. An ablation system comprising an energy output device for selectively delivering ablation energy to the ablation catheter, the ablation energy comprising pulsed ablation and/or radio frequency ablation energy, and an ablation catheter according to any of claims 14-16.
18. The ablation system of claim 17, wherein the energy output device is configured to deliver electrical pulses to the first and second electrodes simultaneously and form monopolar or bipolar pulse ablation; or, the energy output device is used for delivering radio frequency current to at least one of the first electrode and the second electrode for radio frequency ablation; alternatively, the energy output device is configured to selectively deliver electrical pulses to the first and second electrodes or radio frequency current to at least one of the first and second electrodes to cause alternating pulse ablation and radio frequency ablation.
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| CN202110309621.8A CN112842518A (en) | 2021-03-23 | 2021-03-23 | Electrode device, ablation catheter and ablation system |
| PCT/CN2021/139824 WO2022199159A1 (en) | 2021-03-23 | 2021-12-20 | Electrode device, ablation catheter, and ablation system |
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| CN202110309621.8A CN112842518A (en) | 2021-03-23 | 2021-03-23 | Electrode device, ablation catheter and ablation system |
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| WO (1) | WO2022199159A1 (en) |
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| CN113395813A (en) * | 2021-06-30 | 2021-09-14 | 江苏天楹环保能源成套设备有限公司 | Reversed polarity high-power laminar plasma generator |
| CN113616315A (en) * | 2021-07-28 | 2021-11-09 | 华东理工大学 | Pulse ablation method capable of increasing ablation area and controlling ablation direction and liquid electrode |
| WO2022199159A1 (en) * | 2021-03-23 | 2022-09-29 | 上海微创电生理医疗科技股份有限公司 | Electrode device, ablation catheter, and ablation system |
| CN115252114A (en) * | 2022-07-25 | 2022-11-01 | 江苏邦士医疗科技有限公司 | Turbinate hemostatic electrode |
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| US7864129B2 (en) * | 2006-04-04 | 2011-01-04 | Namiki Seimitsu Houseki Kabushiki Kaisha | Radio frequency medical treatment device and system and usage method thereof |
| US20120150165A1 (en) * | 2010-12-10 | 2012-06-14 | Salient Surgical Technologies, Inc. | Bipolar Electrosurgical Device |
| CN104287827B (en) * | 2013-07-19 | 2018-03-02 | 卡尔迪雅（天津）医疗器械有限公司 | One kind removes renal sympathetic nerve radio-frequency ablation electrode and radio frequency ablation system |
| EP3614946B1 (en) * | 2017-04-27 | 2024-03-20 | EPiX Therapeutics, Inc. | Determining nature of contact between catheter tip and tissue |
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| CN112914721A (en) * | 2021-03-23 | 2021-06-08 | 上海微创电生理医疗科技股份有限公司 | Electrode device, medical catheter and ablation system |
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2021
- 2021-03-23 CN CN202110309621.8A patent/CN112842518A/en active Pending
- 2021-12-20 WO PCT/CN2021/139824 patent/WO2022199159A1/en active Application Filing
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| CN113395813A (en) * | 2021-06-30 | 2021-09-14 | 江苏天楹环保能源成套设备有限公司 | Reversed polarity high-power laminar plasma generator |
| CN113616315A (en) * | 2021-07-28 | 2021-11-09 | 华东理工大学 | Pulse ablation method capable of increasing ablation area and controlling ablation direction and liquid electrode |
| WO2023125268A1 (en) * | 2021-12-31 | 2023-07-06 | 杭州德诺电生理医疗科技有限公司 | Catheter, catheter assembly, and occlusion ablation system |
| CN115252114A (en) * | 2022-07-25 | 2022-11-01 | 江苏邦士医疗科技有限公司 | Turbinate hemostatic electrode |
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| WO2022199159A1 (en) | 2022-09-29 |
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