Disclosure of Invention
In order to solve at least one of the above technical problems, an object of the present invention is to provide an electrode device, a medical catheter and an ablation system, which at least solve the problem that the current ablation energy field, especially the pulse electric field, cannot intensively cover the target tissue, so that the target tissue is not thoroughly ablated.
In order to achieve the above object, according to a first aspect of the present invention, there is provided an electrode device comprising a head electrode group including at least two head electrodes connected by a first insulator, and having a specific region, any one of a cross section and any one of a longitudinal section of the specific region including a section of at least two of the head electrodes.
Optionally, the specific region is defined by a distal end face of the electrode device and at least part of an outer peripheral face of the electrode device.
Optionally, each of the head electrodes is configured as a spirally extending curved structure, at least two of the head electrodes are coaxial and spaced apart from each other, and at least two of the head electrodes each spirally extend along the axis of the first insulator;
the first insulator is provided with a concave structure, the concave structure is in a curved surface shape, and at least two head electrodes are arranged at the concave structure.
Optionally, the first insulator comprises a rod-shaped body and a curve structure wound on the rod-shaped body, the curve structure and the rod-shaped body form the concave structure, and each head electrode is matched and fixed with the concave structure.
The head electrode comprises a top cover and at least two first branches connected with the top cover, wherein the at least two first branches are distributed along the circumferential direction of the top cover, and the other head electrode comprises a bottom and at least two second branches connected with the bottom, and the at least two second branches are distributed along the circumferential direction of the bottom;
The number of the first branches is the same as that of the second branches, one first branch is arranged between every two adjacent second branches, one second branch is arranged between every two adjacent first branches, and/or the first branches and the second branches are arranged in parallel.
Optionally, the electrode device further comprises at least one microelectrode for acquiring endocardial signals, the microelectrode and the head electrode being insulated from each other, and/or the electrode device further comprises at least one temperature sensor for acquiring the temperature of the target tissue, the temperature sensor and the head electrode being insulated from each other.
Optionally, when the electrode device comprises a plurality of the microelectrodes, the plurality of microelectrodes are arranged on a distal face of the electrode device and/or on an outer circumferential face of the electrode device.
Optionally, the number of the head electrodes is two, and two microelectrodes are arranged on the distal end face of the electrode device;
At least part of the two head electrodes, at least part of one of the first insulators, and the two microelectrodes are arranged in a Tai-Chi pattern on the distal face of the electrode device, with the first insulator being disposed between the two head electrodes.
Optionally, the number of the head electrodes is three, the three head electrodes are arranged along the circumferential direction of the first insulator and are arranged on the distal end face of the electrode device to form a three-petal structure, the first insulator is arranged between every two adjacent head electrodes, and a microelectrode is arranged on each petal of the distal end face of the electrode device.
Optionally, the electrode device further comprises a plurality of pouring holes for releasing the cooling medium, wherein the pouring holes are arranged on the first insulator or the head electrode.
Optionally, the insulation distance between at least two head electrodes is 0.15 mm-1.5 mm.
Optionally, the electrode device has a smooth outer surface and/or the electrode device is of cylindrical configuration.
Optionally, at least two of the head electrodes are injection-molded with the first insulator.
Optionally, a conductor is provided on the inner side of each of the head electrodes, the conductor penetrating the first insulator and extending in the axial direction of the first insulator.
To achieve the above object, according to a second aspect of the present invention, there is provided a medical catheter comprising a catheter body including a catheter tip provided with any one of the electrode devices.
Optionally, the catheter head end further comprises an elastic tube body and at least one strain gauge, wherein the strain gauge is arranged on the elastic tube body, and the electrode device is connected with the elastic tube body and is coaxially arranged.
Optionally, the catheter tip further comprises a ring electrode set comprising at least one ring electrode, at least one of the ring electrodes being mounted on the tube, and the tip electrode set and the ring electrode set being insulated from each other by a second insulator.
To achieve the above object, according to a third aspect of the present invention, there is provided an ablation system comprising any of the medical catheters, and further comprising an energy output device for selectively outputting ablation energy to the medical catheter, the ablation energy comprising pulsed ablation and/or radiofrequency ablation energy.
Optionally, the energy output device is a radio frequency instrument and/or a pulse generator;
When the energy output device is a radio frequency instrument, the energy output device is used for outputting radio frequency current to at least one head electrode in the medical catheter;
when the energy output device is a pulse generator, the energy output device is configured to output a pulsed current to at least two head electrodes in the medical catheter.
The electrode device, the medical catheter and the ablation system provided by the invention have the following advantages:
The first electrode device and the electrode device are provided with a specific area, any one transverse section and any one longitudinal section of the specific area comprise sections of at least two head electrodes, and when the electrode device is abutted against target tissue, the electrode device and the target tissue can simultaneously abut against the target tissue under any condition, so that the target tissue is ablated more thoroughly or the potential mapping is more accurate;
Secondly, the medical catheter can realize the energy selection of the ablation process after the electrode device is applied, such as radio frequency ablation or pulse ablation, namely, in the ablation process, an operator can select more suitable energy modes to implement ablation according to the complexity of the operation part, the actual condition of a patient or the experience of a doctor, the flexibility of the ablation process is improved, the complexity of the operation is greatly reduced, the operability of the operation is improved, the operation time is effectively shortened, and the risk in the operation process is reduced;
thirdly, the medical catheter can realize pulse discharge of the head electrode group, can effectively reduce muscle stimulation to a patient and improves the safety of ablation.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of the structure of a medical catheter in a preferred embodiment of the invention;
FIG. 2a is an enlarged view of the catheter tip of FIG. 1;
FIG. 2b is a left side view of the catheter head end shown in FIG. 2a, taken along the direction A-A;
FIG. 2c is a transverse cross-sectional view of the catheter head end shown in FIG. 2a, taken along the direction B-B, with the section line not shown;
FIG. 3 is a schematic diagram of the structure of a pressure sensor in a preferred embodiment of the present invention;
FIG. 4a is an exploded view of two head electrodes of a head electrode assembly in a preferred embodiment of the invention;
FIG. 4b is a schematic diagram showing the assembly of two head electrodes in a head electrode set according to a preferred embodiment of the present invention;
FIG. 4c is a schematic view showing the structure of a first insulator in the head electrode assembly according to the preferred embodiment of the present invention;
FIG. 5a is a schematic view of a catheter tip in a preferred embodiment of the invention in abutment with tissue;
FIG. 5b is a schematic view of the tip of the catheter in accordance with the preferred embodiment of the invention after positioning against tissue;
FIG. 6a is a schematic diagram showing the relative positions of two head electrodes in front view in a preferred embodiment of the present invention;
FIG. 6b is a schematic diagram showing the relative positions of two head electrodes in a left view in a preferred embodiment of the present invention;
FIG. 6c is a schematic diagram showing the relative positions of two head electrodes in a top view in a preferred embodiment of the present invention;
FIG. 6d is a schematic view taken along line C-C of FIG. 6C;
fig. 7a is a front view of a head electrode assembly in a preferred embodiment of the present invention;
FIG. 7b is a perspective view of a head electrode assembly in a preferred embodiment of the invention;
FIG. 7c is a top view of a head electrode assembly in a preferred embodiment of the invention;
FIG. 8 is an exploded view of two head electrodes of a head electrode assembly in accordance with another preferred embodiment of the present invention;
FIG. 9a is a schematic diagram showing the relative positions of two head electrodes in a front view in accordance with another preferred embodiment of the present invention;
FIG. 9b is a schematic diagram showing the relative positions of two head electrodes in a left view in accordance with another preferred embodiment of the present invention;
FIG. 9c is a schematic diagram showing the relative positions of two head electrodes in a top view in accordance with another preferred embodiment of the present invention;
fig. 9d is a schematic perspective view showing the relative positions of two head electrodes in another preferred embodiment of the present invention.
The reference numerals are explained as follows:
100-catheter head end, 101-head electrode set, 101 a-spiral section, 101 b-straight line section, 1-first head electrode, 111-top cap, 112-first branch, 2-second head electrode, 211-bottom, 212-second branch, 18-third head electrode, 3-microelectrode, 3-1 first microelectrode, 3-2-second microelectrode, 102-ring electrode set, 5-first ring electrode, 6-second ring electrode, 7-third ring electrode, 4-1-first insulator, 411-rod body, 412-curve configuration, 413-concave structure, 4-2-second insulator, 8-tube, 103-handle assembly, 9-bend control pusher, 10-handle, 11-signal port, 12-energy port, 13-cooling medium pouring port, 14-pouring channel, 15-bend control channel, 16-wire channel, 17-target tissue, 104-elastic tube, 105-strain gauge.
Detailed Description
In order to make the contents of the present invention more clear and understandable, the present invention will be further described with reference to the drawings attached to the specification. Of course, the invention is not limited to this particular embodiment, and common alternatives known to those skilled in the art are also encompassed within the scope of the invention. Next, the present invention will be described in detail with reference to the drawings, which are only for the purpose of detailing examples of the present invention, and should not be construed as limiting the present invention.
In addition, each embodiment of the following description has one or more features, respectively, which does not mean that the inventor must implement all features of any embodiment at the same time, or that only some or all of the features of different embodiments can be implemented separately. In other words, those skilled in the art can implement some or all of the features of any one embodiment or a combination of some or all of the features of multiple embodiments selectively, depending on the design specifications or implementation requirements, thereby increasing the flexibility of the implementation of the invention where implemented as possible.
Herein, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the product, although "proximal" and "distal" are not limiting, and "proximal" generally refers to the end of the product that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters 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 term "circumferential" generally refers to a direction about the axis of the medical catheter, the term "longitudinal" generally refers to a direction parallel to the axis of the medical catheter, and the term "transverse" generally refers to a direction perpendicular to the axis of the medical catheter.
An object of the present invention is to provide an electrode device comprising a head electrode group comprising at least two head electrodes connected to each other by a first insulator, and having a specific region, any one of the cross-section and any one of the longitudinal sections of which contains at least two of the cross-sections of the head electrodes. The specific area of the electrode means may be provided in some or all of the whole electrode means, preferably defined by the distal surface of the electrode means and at least part of the outer circumferential surface of the electrode means. "distal face" refers to the face of the distal end of the electrode assembly. So constructed, the medical catheter, such as an ablation catheter, using the electrode device can achieve that at least two head electrodes are simultaneously attached to target tissue under any condition when the electrode device is attached to the target tissue, so that the target tissue is ablated more thoroughly or the potential mapping is more accurate. It should be understood that the head electrode is not limited to an electrode for ablation, but may be an electrode for mapping.
It is a further object of the present invention to provide a medical catheter, which may be an ablation catheter or a mapping catheter. The medical catheter comprises a catheter body comprising a catheter tip provided with the electrode device of the invention. When the head electrode in the electrode device is used for ablation, radiofrequency energy ablation can be used, pulsed electric field ablation can be used, namely, the head electrode can receive pulse current to achieve the purpose of pulse ablation, and can also receive high-frequency current to achieve the purpose of radiofrequency ablation. Therefore, the medical catheter can realize the energy selection in the ablation process, namely, an operator can select a more suitable energy mode to implement the ablation according to the complexity of an operation part, the actual condition of a patient or the experience of a doctor in the ablation process, so that the flexibility of the ablation process is improved, the complexity of the operation is greatly reduced, the operability of the operation is improved, the operation time is effectively shortened, and the risk in the operation process is reduced. More specifically, during radio frequency ablation, one of the head electrodes can be selected to be electrically conducted to receive high-frequency current, or more of the head electrodes can be selected to be conducted to receive high-frequency current, while during pulse ablation, at least one pair of the head electrodes can be selected to be electrically conducted, or more of the head electrodes can be selected to be conducted, and the pulse ablation is preferably bipolar ablation, namely the polarities of the two head electrodes in the pair of the head electrodes are opposite. It should also be understood that the medical catheter of the present invention is not limited to cardiac ablation, but may be used for ablation of other sites (e.g., kidneys) or diseases. Therefore, in the whole ablation process, at any time and any position, when the medical catheter is in contact with the tissue, at least two head electrodes can be simultaneously attached to the target tissue, so that an ablation energy field, particularly a pulse electric field, can cover the target tissue as much as possible instead of blood, and a better ablation effect or a better potential mapping effect can be achieved.
Further, the catheter head end further comprises an elastic tube body and at least one strain gauge, wherein at least one strain gauge is arranged on the elastic tube body, and the electrode device is connected with the elastic tube body and is coaxially arranged. At this point, the medical catheter forms a pressure sensor at the distal end that monitors the force applied to the distal end of the catheter. The present invention is not limited to the structure of the elastic tube body, and it is known that excellent elasticity can be imparted to the elastic tube body by various means, such as a plastic tube or a rubber tube (polymer material) having elasticity or a metal tube, which is preferably made of a metal material having a shape memory function, including but not limited to nickel-titanium alloy. The strain gauge is preferably three strain gauges, and at least three strain gauges are uniformly distributed in the circumferential direction of the elastic tube body. The strain gauge may be a conventional single-bridge strain gauge or a half-bridge strain gauge, or may be an irregular strain gauge such as a shear slice or a strain gauge, and the strain gauge of the corresponding type is selected mainly according to the structure of the elastic tube body, and is not particularly limited. Therefore, when the electrode device is contacted with the wall of a blood vessel or the surface of a tissue, tissue ablation or potential mapping can be performed on the distal end of the catheter through the head electrode, the magnitude and the direction of the contact force can be obtained when the electrode device is contacted with the tissue, and the electrical signal of the pressure sensor changes after the elastic tube body is subjected to the contact force, and the magnitude and the direction of the contact force can be obtained according to the changed electrical signal. That is, the strain gauge senses deformation of the elastic tube body to output a varying electrical signal.
It is a further object of the present invention to provide an ablation system comprising a medical catheter of the present invention, and further comprising an energy output device, which may be a radiofrequency instrument and/or a pulse generator, for selectively outputting ablation energy to the medical catheter. For example, when the energy output device is a radiofrequency instrument, a high frequency current is sent to an electrode device in the medical catheter to achieve radiofrequency ablation, and when the energy output device is a pulse generator, a pulse current is sent to the electrode device in the medical catheter to achieve pulse ablation.
Further, the catheter head end further comprises a ring electrode set comprising at least one ring electrode, at least one of the ring electrodes being mounted on the tube or the elastic tube, and the head electrode set and the ring electrode set being insulated from each other by a second insulator. The ring electrode set is used for potential mapping, such as mapping the location of arrhythmia. The number of the ring electrodes is not limited in the present invention, and may be one, two, three or more.
Further, the medical catheter of the present invention further comprises a traction device and a handle assembly. The traction device is arranged in the pipe body. The handle assembly is connected to the proximal end of the tube and is used to control the traction device to adjust the position and orientation of the head electrode assembly. In more detail, the traction device comprises a bending control cable, the medical catheter is provided with a bendable section, the bending control cable is connected with the bendable section and the handle assembly, the bending control cable controls the bendable section to bend so as to adjust the position and the direction of the head electrode group, the head electrode group reaches various complex and fine tissue structures, and ablation energy is applied to target tissues through the head electrode group. Preferably, the electrode device is further used for extracting cardiac electrocardiosignals, at this time, the electrode device further comprises at least one microelectrode used for collecting cardiac signals, and at least one microelectrode is arranged in an insulating manner with all head electrodes. The number of microelectrodes is not limited in the present invention, and may be one, two, three or more. Preferably, the electrode device further has a temperature detection function for monitoring the actual temperature of the tissue during ablation to adjust the output of ablation energy according to the temperature feedback, and at this time, the electrode device further includes at least one temperature sensor, which may be disposed on the head electrode or the microelectrode, and insulated from the electrodes. More preferably, the temperature sensor is integrated with the microelectrode. The term "integrated" means that the temperature sensor is provided on the microelectrode, and preferably the temperature sensor is provided inside the microelectrode, so that the microelectrode has a function of detecting the temperature itself.
The electrode device, medical catheter and ablation system according to the present invention will be further described with reference to the accompanying drawings and preferred embodiments. In the following description, the head electrode group includes two or three head electrodes, and the ablation catheter is shown, but the description is not limited to this, and the solution of the present invention is equally applicable to the case of more head electrodes, and to the case of mapping catheters or other medical catheters for use.
Fig. 1 is a schematic view of a medical catheter according to a preferred embodiment of the present invention, fig. 2a is an enlarged view of the catheter tip shown in fig. 1, fig. 2B is a view of the catheter tip shown in fig. 2a in the direction A-A, and fig. 2c is a transverse cross-sectional view of the catheter tip shown in fig. 2a in the direction B-B.
Referring to fig. 1, 2 a-2 c, the present embodiment provides a medical catheter compatible with radio frequency and pulsed field ablation. The medical catheter comprises a tube 8, said tube 8 comprising a catheter head 100, the catheter head 100 being adapted for performing ablation or potential mapping against a target tissue. It should be appreciated that the area encircled by the dashed line in fig. 1 is the catheter tip 100, and the catheter tip 100 in fig. 1 has been enlarged for ease of understanding.
Wherein the catheter tip 100 is provided with an electrode arrangement comprising a set of tip electrodes 101, the set of tip electrodes 101 comprising at least two tip electrodes, the junction of the at least two tip electrodes being provided with a first insulator for insulating the tip electrodes from each other. In particular, the head electrode group 101 has a specific region for being abutted against a target tissue, and any one of the cross sections and any one of the longitudinal sections of the specific region include the cross sections of at least two head electrodes. It should be understood that any one cross section of the specific area includes a cross section of at least two head electrodes and any one longitudinal section of the specific area includes a longitudinal section of at least two head electrodes. Preferably, the outer surface (mainly the distal surface) of the head electrode group 101 in the transverse direction contains at least two head electrodes, and at least part of the outer surface (i.e. the outer peripheral surface) in the circumferential direction contains at least two head electrodes, and preferably, the specific area is defined by the distal surface of the electrode device and at least part of the outer peripheral surface of the electrode device. By doing so, at least two head electrodes can be simultaneously attached to the target tissue when the catheter head end 100 is attached to the target tissue in the whole ablation process, the ablation energy field (preferably the pulse electric field) is enabled to cover the target tissue as much as possible instead of blood, a better ablation effect is achieved, the ablation is more thorough, and therefore the ablation effect is improved. That is, the medical catheter of the embodiment can achieve more accurate and comprehensive ablation, greatly reduce the complexity of the operation, enhance the operability of the operation, shorten the operation time and reduce the risk in the operation process.
Optionally, the head electrode group 101 includes two head electrodes, namely, the first head electrode 1 and the second head electrode 2. The two head electrodes can form a positive electrode loop and a negative electrode loop during pulse discharge, so that bipolar pulse discharge is realized, the two head electrodes are in contact with target tissues for ablation or mapping, the two head electrodes are attached to the tissues at any circumferential position of the catheter head end 100, the first head electrode 1 and the second head electrode 2 can be attached to the target tissues at the same time to the greatest extent, and the two head electrodes can be attached to the target tissues at the distal end face of the catheter head end 100 at the same time. In other embodiments, the two head electrodes may be used simultaneously or alternatively as energy input electrodes during radio frequency ablation. Of course, in other embodiments, the polarities of the two head electrodes may be the same at the time of pulse discharge, thereby realizing unipolar pulse discharge.
Further, the catheter head 100 further includes a ring electrode set 102 for performing target tissue potential mapping, where the ring electrode set 102 is mainly used for potential mapping and the head electrode set 101 is used for tissue ablation. Of course, in other embodiments, the ring electrode set 102 may also be used for tissue ablation, the head electrode set 101 for potential mapping, or the ring electrode set 102 may be used in conjunction with the head electrode set 101 for ablation or potential mapping. The ring electrode set 102 includes one ring electrode or a plurality of ring electrodes (a plurality means at least two). Alternatively, the set of ring electrodes 102 comprises three ring electrodes, a first ring electrode 5, a second ring electrode 6 and a third ring electrode 7, respectively, which are arranged axially spaced apart on the body of the catheter tip 100 and insulated from each other. Further, the head electrode group 101 and the ring electrode group 102 are insulated from each other by the second insulator 4-2. In this embodiment, the joint of the head electrodes in the head electrode group 101 is insulated from each other by the first insulator 4-1, and the head electrode group 101 and the ring electrode group 102 are insulated from each other by the second insulator 4-2. Further, the second insulator 4-2 is integrally formed or separately connected with the first insulator 4-1, and further, the second insulator 4-2 is annular and sleeved on the first insulator 4-1, so that the second insulator 4-2 is located between the head electrode set 101 and the first ring electrode 5, and the second insulator 4-2 is preferably closely attached to the proximal end face of the head electrode set 101 and the distal end face of the first ring electrode 5.
Preferably, the electrode device is a prism without edges, i.e. has a smooth outer surface, so as to prevent adverse tip discharge and avoid generating electric arcs to influence the ablation effect. Here, the head (i.e., distal end) of the electrode device is also smooth without sharp corners, for example, the head is a smooth plane or a smooth curved surface (e.g., a spherical surface), further, the electrode device is a cylindrical structure, and the distal end of the electrode device is smoothly transitioned with the outer circumferential surface. In addition, when the number of the head electrodes is two, the insulation pitch between the two head electrodes is preferably 0.15mm to 1.5mm, for example, the insulation pitch at the junction of the first head electrode 1 and the second head electrode 2 is 0.15mm to 1.5mm. Similarly, when the number of the head electrodes is three or more, the insulation distance between any two adjacent head electrodes is 0.15mm to 1.5mm. Here, it is understood that since the pulse electric field is released between the two head electrodes by positive and negative electrode signals, if the inter-head electrode distance is too small, an electric spark phenomenon and a low temperature plasma effect are easily generated, and if the inter-head electrode distance is too far, an influence on the electric field intensity is exerted, and in view of these problems, the distance between the two head electrodes is designed to be in the above range, which can ensure the electric field energy intensity and does not generate ionization. Preferably, the head electrode group 101 and the first insulator 4-1 are integrally injection molded in a micro precise injection molding mode, so that the connection strength is high and the stability is high. In other embodiments, the connection between the head electrode assembly 101 and the first insulator 4-1 may be achieved by machining, which is not limited herein.
It is further preferred that the head electrode set 101 further comprises at least one microelectrode 3 for acquiring endocardial signals and/or target tissue temperatures. At least one of the microelectrodes 3 may be mounted on the head electrode or on the first insulator 4-1, and the microelectrode 3 and the head electrode are insulated from each other. In this embodiment, the microelectrode 3 is mounted on the head electrode, for example, a microelectrode mounting hole is provided on the head electrode, and the microelectrode 3 is placed in the microelectrode mounting hole and is insulated from the head electrode. For example, the microelectrode 3 and the head electrode are bonded by glue, so that electrical isolation from each other is achieved by glue, for example, the microelectrode 3 is fixed on the first head electrode 1 or the second head electrode 2 by using medical insulation glue. Or a nonmetallic insulator is added between the microelectrode 3 and the head electrode to realize mutual isolation. Preferably, the number of the microelectrodes 3 is 2 to 8, in this embodiment, the number of the microelectrodes 3 is 4, and two first microelectrodes 3-1 and two second microelectrodes 3-2 are respectively provided, and optionally, two first microelectrodes 3-1 are located on the distal end face of the head electrode group 101, and two second microelectrodes 3-2 are located on the outer peripheral face (side face) of the head electrode group 101, but the number and arrangement manner of the microelectrodes 3 are not limited to this example, and in other embodiments, a plurality of microelectrodes 3 are arranged on the distal end face and/or the outer peripheral face of the electrode device. The microelectrode 3 is made of metal and is used for detecting electrocardiosignals, and preferably, a temperature sensor is arranged in the microelectrode 3 and is used for monitoring the actual temperature of tissues in the ablation process. In other embodiments, the temperature sensors may also be disposed within the head electrode and insulated from each other. The position of the microelectrode 3 is not particularly limited in the present invention, and for better detection of electrocardiographic signals and/or temperature, it is preferable that the microelectrode 3 is provided on the side (outer peripheral surface) of the electrode device and/or on the distal end surface of the electrode device. More preferably, microelectrode mounting holes are provided in both the distal end face and the side face of the electrode device, and microelectrodes 3 are provided in these microelectrode mounting holes. Further, holes are provided in the microelectrode 3, and TC lines (temperature sensor wires) can be placed.
Referring to fig. 1, the medical catheter further comprises a handle assembly 103 and a pulling device (not shown), the handle assembly 103 being connected to the proximal end of the tube body 8, the pulling device being arranged inside the tube body 8. The handle assembly 103 is used to control the traction device to adjust the position and orientation of the head electrode assembly 101. Further, the handle assembly 103 comprises a bending control pushing piece 9 and a handle 10, wherein the bending control pushing piece 9 is arranged at the proximal end of the tube body 8 and is positioned between the tube body 8 and the handle 10, and the bending control pushing piece 9 controls the traction device to draw so as to bend the bendable section of the tube body 8, so that the head electrode group 101 is guided to approach the target tissue.
Preferably, the catheter head 100 further comprises a pressure sensor, and the pressure of the catheter head 100 against the target tissue is sensed by the pressure sensor of the catheter head 100, and the abutment strength or the abutment is evaluated. With further reference to fig. 3, the pressure sensor comprises an elastic tube 104 and at least one strain gauge 105, the at least one strain gauge 105 being disposed on the elastic tube 104. The at least one strain gauge 105 is configured to sense deformation of the elastic tube 104 to output a varying electrical signal according to the deformation of the elastic tube 104, thereby obtaining a pressure of the catheter head end 100 against the target tissue according to the varying electrical signal. Preferably, the number of the strain gages 105 is three, and the three strain gages 105 are uniformly arranged along the circumferential direction of the elastic tube 104, and may be arranged on the same circumference or different circumferences.
Referring back to fig. 1, the handle assembly 103 includes a signal port 11 and an energy port 12. The microelectrode 3 and the strain gauge 105 are connected with a signal port 11 at the proximal end of the handle 10 through wires, and the signal port 11 can timely respond to the performance of the catheter (including temperature, pressure, electrocardiosignal and other information) through a signal display instrument. With further reference to fig. 2c, a plurality of wire channels 16 are disposed in the tube 8, and the wires and TC wires of the microelectrode 3 pass through the wire channels 16 and then are connected to the signal port 11 at the proximal end of the handle 10. Each of the head electrodes 101 is also connected to a lead wire which passes through the lead passageway 16 and is connected to the power port 12 at the proximal end of the handle 10. In this embodiment, the inner sides of the first head electrode 1 and the second head electrode 2 are connected with wires, preferably, conductors are arranged when the head electrode group 101 is formed, specifically, a conductor (a wire or a core rod) is led out of the inner walls of the first head electrode 1 and the second head electrode 2, and the conductor penetrates into the first insulator 4-1 and extends along the axial direction of the first insulator 4-1 for connecting with the rear end energy port 12. Correspondingly, the ring electrode in the ring electrode set 102 is connected with a wire, and the wire also passes through the wire channel 16 to be connected with the signal port 11 at the proximal end of the handle. The wire channels 16 may be one or more.
In addition, the embodiment of the application also provides an ablation system, which comprises the medical catheter and an energy output device, wherein the energy output device is used for selectively outputting ablation energy to an electrode device in the medical catheter, and the ablation energy comprises pulse ablation and/or radio frequency ablation energy. In some embodiments, the energy output device is a radio frequency instrument that delivers high frequency current to at least some of the head electrodes in the head electrode set 101 through the energy port 12. In some embodiments, the energy output device is a pulse generator that delivers a pulsed current to at least two of the head electrodes of the head electrode set 101 through the energy port 12, forming a pulsed field ablation. In other embodiments, the energy output device is a radio frequency pulse generator, the radio frequency energy or pulse energy is integrated into one device, or the radio frequency energy is processed to send out a pulse signal, and then the energy is transferred to the medical catheter to realize ablation, so that the application is not limited.
Preferably, the catheter head 100 comprises a plurality of filling holes (not shown), while the interior of the tube 8 is provided with filling channels 14 (fig. 2 c), the filling channels 14 being in communication with the filling holes. The number of irrigation holes is preferably a plurality, preferably uniformly arranged, the irrigation holes being generally arranged along the circumference of the head electrode. The pouring hole may be provided on the head electrode or on the first insulator 4-1. In actual ablation procedures, a cooling medium such as saline or other substances may be optionally used to cool the target tissue or the electrode at the catheter tip 100 to more precisely control the target tissue temperature or the temperature of the electrode at the catheter tip. Specifically, the cooling medium is poured through the cooling medium pouring opening 13 at the proximal end of the handle 10, so that the cooling medium flows to the pouring holes on the catheter head end 100 along the pouring channel 14 in the tube body 8. In addition, a bending control channel 15 is further arranged in the pipe body 8, and a bending control cable is arranged in the bending control channel 15 and connected with the bending control pushing piece 9.
Referring next to fig. 4a to 4c, and in combination with fig. 2a and 2b, in some embodiments, the set of head electrodes 101 is a hyperbolic structure, such as a double helix extending in a spiral direction or in a reverse direction, for example, the first head electrode 1 and the second head electrode 2 are both spirally configured, coaxially and at a distance from each other, to form a double helix, and the two helices are simultaneously helical in the same direction or in opposite directions, and the head electrodes spirally extend along the axis of the first insulator 4-1. Meanwhile, the first insulator 4-1 has a concave structure, the concave structure is in a curved surface shape, the curved surface shape can be a spiral curved surface or a wavy curved surface, and the first head electrode 1 and the second head electrode 2 are arranged at the concave structure of the first insulator 4-1 and are fixedly connected with the first insulator 4-1. In addition, the inner sides of the first head electrode 1 and the second head electrode 2 (i.e. the side close to the axis of the first insulator) are respectively led out of a wire, and the wire of the head electrode passes through the first insulator 4-1 and then enters the wire channel 16 in the tube body 8 to be connected with the energy port 12 at the proximal end of the handle 10.
It should be understood that, the head electrode set 101 adopts a spiral extending curve structure design, which not only ensures the requirement that the positive and negative electrodes are simultaneously attached to the target tissue during the ablation of the pulsed electric field, but also makes the electrode head more flexible than the common electrode, and is more suitable for the requirement that the ablation is attached to the tissue, and the attaching effect is good.
Referring to fig. 5a and 5b, the catheter head end 100 of the medical catheter provided in this embodiment can achieve double-electrode simultaneous abutment at different abutment positions, and the catheter head end 100 and the target tissue 17 abut against (including side abutment, head end abutment, etc.) in any situation, and the catheter head end 100 can achieve double-electrode simultaneous abutment against the target tissue 17, so that the target tissue is ablated more thoroughly, and the ablation effect is better. In more detail, as shown in fig. 6a, two head electrodes are covered in a front view, i.e., the head portion (i.e., the distal end surface, also having a transverse cross section) of the head electrode group 101, as shown in fig. 6b, two head electrodes are covered in a left side surface of the head electrode group 101, as shown in fig. 6C, two head electrodes are covered in an upper side surface of the head electrode group 101, as shown in fig. 6C, and two head electrodes are covered in a longitudinal cross section cut along a C-C line shown in fig. 6C, as shown in fig. 6 d. Thus, at any time and at any location, the contact surface of the outer surface of catheter head end 100 with target tissue 17 covers both head electrodes. Thus, a bipolar discharge terminal is formed by the rotational fit of the first and second head electrodes 1 and 2.
Referring back to fig. 4c, the first insulator 4-1 may be at least partially of a curved structure, specifically includes a rod-shaped body 411 and a curved structure 412 wound around the rod-shaped body 411, the curved structure 412 may be a spiral structure or a wave-shaped structure, a concave structure 413 is formed between the curved structure 412 and the rod-shaped body 411, the shape of the concave structure 413 may be a spiral concave structure or a wave-shaped concave structure, the concave structure 413 is exactly matched with the first head electrode 1 and the second head electrode 2, and after the two head electrodes are installed at the concave structure 413, the two head electrodes can be insulated from each other. In addition, a plurality of wire passages may be formed inside, on the side surfaces or between the inside and outside of the rod-shaped body 411 for arranging wires. Preferably, the head electrode is connected to the first insulator 4-1 by micro precision injection molding. In addition, the second insulator 4-2 may be sleeved on the first insulator 4-1, and more preferably, the first insulator 4-1 and the second insulator 4-2 are in an integrated structure. In the present embodiment, the insulation properties of the first head electrode 1 and the second head electrode 2 from the first ring electrode 1 are ensured by the second insulator 4-2. Further, at least part of the first header electrode 1, at least part of the second header electrode 2, at least part of the first insulator 4-1 and the microelectrode 3 are arranged in a Tai pattern on the distal face of the electrode arrangement, see in particular FIGS. 2b and 6a.
In other embodiments, referring to fig. 7a to 7c, the head electrode set 101 may further include three head electrodes, namely, a first head electrode 1, a second head electrode 2 and a third head electrode 18, each of which is in a spiral structure, and the three head electrodes are coaxially and mutually spaced to form a triple spiral, and the triple spirals spiral in the same direction or opposite directions. In this embodiment, three spirals are arranged in parallel in the same direction and extend helically along the axis of the first insulator. Further, the first head electrode 1, the second head electrode 2 and the third head electrode 18 are arranged along the circumferential direction of the first insulator 4-1 and are arranged on the distal end face of the electrode device to form a three-petal structure, the first insulator 4-1 is arranged between every two adjacent head electrodes, and preferably, one microelectrode 3 is arranged on each petal of the distal end face of the electrode device. It should be understood that the first insulator 4-1 is not shown in fig. 7a and 7 b.
Further, each head electrode includes a spiral section 101a and a straight section 101b (refer to fig. 7 a), the straight section 101b being located at one or both ends of the spiral section 101b, and correspondingly, the concave structure 413 on the first insulator 4-1 also has a spiral section and a straight section. The spiral section 101a of the head electrode cooperates with the spiral section of the recess 413 and the straight section 101b cooperates with the straight section of the recess 413. The head electrode may be a variable diameter spiral or a spiral with a constant diameter, and is specifically adjusted according to actual needs. In addition, the spiral shape and size of each head electrode are not limited, and can be set according to actual operation requirements. And here, make a plurality of head electrodes arrange under the condition of the same electrical parameter through double helix or more spiral, electric field distribution is more even, and the ablation effect is better.
Referring to fig. 8 in combination with fig. 9a to 9d, in a further embodiment, a further configuration of the head electrode set 101 is provided, the head electrode set 101 also comprising a first head electrode 1 and a second head electrode 2, with the difference that the first head electrode 1 comprises a cap 111 and a plurality of first branches 112 (a plurality comprising at least two) distributed (preferably evenly distributed) along the circumference of the cap 111, preferably the cap 111 has a smooth outer surface, such as a circular arc-shaped outer surface. The top cover 111 and/or the first branches 112 are preferably provided with microelectrode mounting holes for placing microelectrodes 3, the second head electrode 2 comprises a bottom 211 (preferably circular ring-shaped) and a plurality of second branches 212 circumferentially distributed (preferably uniformly distributed) along the bottom 211, the second branches 212 are preferably provided with microelectrode mounting holes for placing microelectrodes 3, the number of the first branches 112 of the first head electrode 1 is the same as the number of the second branches 212 of the second head electrode 2, for example, the number of the branches is 2-4, the first head electrode 1 and the second head electrode 2 are nested, so that one first branch 112 is arranged between every two adjacent second branches 212, and one second branch 212 is arranged between every two adjacent first branches 112. And/or the first branch 112 of the first header electrode 1 and the second branch 212 of the second header electrode 2 are arranged parallel to each other. Furthermore, a first insulator 4-1 is arranged at the joint of the first head electrode 1 and the second head electrode 2, and is used for isolating the first head electrode 1 and the second head electrode 2. Preferably, the head electrode group 101 and the first insulator 4-1 are combined into a cylinder with a smooth distal end, the distal end of the cylinder is in smooth transition, and meanwhile, no edge angle of each head electrode is ensured, adverse tip discharge is prevented, electric arc is generated, and ablation effect is affected. In this embodiment, the head electrode group 101 and the first insulator 4-1 are preferably integrally combined by integral precision injection molding. The distance (i.e., insulation pitch) between the junction of the first header electrode 1 and the second header electrode 2 is preferably 0.15mm to 1.5mm.
In summary, the electrode device can realize pulse discharge to perform pulse field ablation, and the pulse field ablation can effectively reduce muscle stimulation to a patient. In addition, the invention can realize that a plurality of head electrodes are simultaneously attached to target tissues at any time and any position in the whole ablation process, so that the pulse electric field can cover the target tissues as much as possible instead of blood, and a better ablation effect is achieved. In addition, the invention can realize the energy selection in the ablation process, namely, in the ablation process, an operator can select more suitable energy modes to implement the ablation according to the complexity of the operation part, the actual condition of the patient or the experience of doctors, so that the operation is more flexible and convenient. The invention is compatible with radio frequency ablation and pulse ablation, can achieve more accurate and comprehensive ablation, greatly reduces the complexity of operation, enhances the operability of operation, shortens the operation time and reduces the risk in the operation process.
It should be understood that the foregoing is merely a preferred embodiment of the present invention, and is not intended to limit the present invention in any form or nature, and that the innovation of the present invention is derived from cardiac ablation, but one skilled in the art will appreciate that the present invention is applicable to ablation of various sites such as renal artery ablation, bronchial ablation, etc., and the present invention is not limited in this regard.
The above description is only a preferred embodiment of the present invention, and is not limited in any way and in any nature, for example, the present invention is not limited to a spiral-shaped head electrode set, and is not limited to a 2U-shaped head electrode nested head electrode set, so long as it is ensured that at least two electrodes can simultaneously abut against a target tissue when the head electrode set contacts the target tissue at any position during the whole ablation process. Moreover, although the innovations of the present invention originate from the field of ablation catheters and their ablation technology, those skilled in the art will appreciate that the present invention is also applicable to mapping catheter technology.
It should be noted that several modifications and additions will be possible to those skilled in the art without departing from the method of the invention, which modifications and additions should also be considered as within the scope of the invention. Those skilled in the art will appreciate that many modifications, adaptations and variations of the present invention can be made using the techniques disclosed herein without departing from the spirit and scope of the invention, and that many modifications, adaptations and variations of the present invention are within the scope of the invention as defined by the appended claims.