CN117752404B - Cardiac electrophysiology mapping and ablation catheter - Google Patents
Cardiac electrophysiology mapping and ablation catheter Download PDFInfo
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- CN117752404B CN117752404B CN202410194817.0A CN202410194817A CN117752404B CN 117752404 B CN117752404 B CN 117752404B CN 202410194817 A CN202410194817 A CN 202410194817A CN 117752404 B CN117752404 B CN 117752404B
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Abstract
The invention relates to the technical field of electrophysiology catheters, in particular to a heart electrophysiology mapping and ablation catheter, which comprises a sheet-shaped head end and an electrode, wherein the sheet-shaped head end comprises an annular member and a middle ridge, the middle ridge is connected in the annular member, the electrode comprises a central electrode and a plurality of outer electrodes, the polarities of the outer electrodes and the central electrode are opposite, the central electrode is arranged on the middle ridge, the outer electrodes are arranged on the annular member, the electrodes form an array on the sheet-shaped head end, the annular member and the middle ridge are made of thermoplastic elastic materials or shape memory alloy, and the electrode acquires a physiological signal or transmits high-voltage pulse electric field energy. The polarities of the central electrode and the outer electrode are different, and the electrodes have enough space barriers, so that whether the electrodes can withstand high-voltage pulse electric field energy during discharge or not is not required to be considered; the central electrode and the outer electrode are used for mapping and ablation, so that the switching frequency of the catheter in operation is reduced, the economic burden of a patient is reduced, and the high-voltage pulse electric field is used as ablation energy for tissue ablation, so that the ablation time is short and the effect is good.
Description
Technical Field
The invention relates to the technical field of electrophysiology catheters, in particular to a heart electrophysiology mapping and ablation catheter.
Background
Ischemic cardiomyopathy is the main cause of ventricular arrhythmias. The current common catheter treatment approach is to block reentry of scar tissue around the anatomical barrier (annulus) or myocardium by radio frequency ablation. The scar tissue has myocardial cells, collagen, fat and other tissue distributed simultaneously, and is one complicated inhomogeneous structure with different biophysical and thermodynamic properties. The damage range of myocardial cells in the scar area is irregular and the damage degree is unpredictable in the process of radio frequency ablation under the influence of collagen and adipose tissue. Myocardial cells may still survive rf ablation in the scar region. This may be the primary cause of recurrence of the arrhythmia following surgery in the patient. Meanwhile, radio frequency ablation is mostly single-point ablation, and dozens of times of ablation may be needed for ventricular arrhythmia to achieve an ideal treatment effect, so that the workload is large and the operation efficiency is low.
Overall, the rf ablation catheter treats ventricular arrhythmias with long surgical time, low efficiency, and a high likelihood of recurrence.
Disclosure of Invention
The invention aims at: aiming at the problems of long operation time, lower efficiency and higher possibility of recurrence in the prior art of using a radio frequency ablation catheter for radio frequency ablation to treat ventricular arrhythmia in the prior art, the invention provides a cardiac electrophysiology mapping and ablation catheter.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
The utility model provides a heart electrophysiology mapping and ablation pipe, includes slice head end and electrode, slice head end includes annular component and middle spine, middle spine connect in the annular component, the electrode includes at least one center electrode and a plurality of outside electrode, outside electrode with the polarity of center electrode is opposite, center electrode locates on the middle spine, outside electrode locates on the annular component, the electrode is in form the array on the slice head end, annular component with middle spine adopts thermoplastic elastic material or shape memory alloy, the electrode is used for adopting the electrophysiology signal or transmits high voltage pulse electric field energy.
Conduction of electrical signals in the heart near myocardial scar tissue is disorderly, and accurate mapping is of great importance for diagnosis of cardiac arrhythmias. During the diagnostic process, electrode pairs can be formed between the electrodes, and bipolar electrophysiological signals of the mapping region are acquired. During treatment, the central electrode and any one or more of the outer electrodes can form an electrode pair, and pulse electric field ablation can be performed on the coverage area. This requires only a short time to achieve ablation of a larger area.
The annular member and the intermediate ridge form a supporting framework for the sheet-like head end, and are made of a soft and elastic material, so that the sheet-like head end can conform to the shape of the tissue when contacting the tissue, deform, and quickly return to an original shape when leaving the tissue. Meanwhile, the sheet-shaped head end can also be contracted or curled into a smaller size along the central axis direction of the catheter, pass through the sheath, and be unfolded into a plane shape when the sheath is discharged.
By adopting the cardiac electrophysiology mapping and ablation catheter disclosed by the invention, the polarities of the central electrode and the outer electrode are different, the distribution areas are different, and sufficient space barriers are arranged between the electrodes with different polarities, so that whether high-voltage pulse electric field energy can be tolerated between the electrodes during discharge is not needed to be considered too much at the sheet-shaped head end with limited space; meanwhile, the center electrode and the outer electrode are used for mapping and ablation, so that the switching frequency of a catheter in operation is reduced, the economic burden of a patient is reduced, a high-voltage pulse electric field is used as ablation energy for tissue ablation, the ablation time is shorter, the ablation effect is more reliable, and multiple operations are not needed; the catheter has the advantages of simple structure, convenient use and good effect.
As a preferred solution of the invention, the annular member and the intermediate ridge lie in the same plane.
As a preferable technical scheme of the invention, the annular member is annular, the electrode comprises a central electrode, the central electrode is positioned at the center of the circle of the annular member, and the central electrode and each outer electrode are equidistantly arranged.
By adopting the structure, the ablation area of the sheet-shaped head end can be divided into a plurality of sectors according to the distribution of the outer electrodes, and the sectors needing to be ablated can be selected according to the requirement in the ablation process.
As a preferable technical scheme of the invention, the annular member is polygonal, the polygonal comprises two sides which are arranged in parallel, the sides are parallel to the axis of the catheter and the middle ridge, a plurality of center electrodes are arranged on the middle ridge at intervals, the outer electrodes corresponding to the positions of the center electrodes are arranged on the sides, and the distances from the center electrodes to the adjacent two outer electrodes are equal.
By adopting the structure, the electrode areas distributed in the transverse and longitudinal arrays are formed between the central electrode and the outer electrode, and during diagnosis, the electrodes distributed in the transverse and longitudinal arrays can simultaneously identify the transverse and longitudinal conductive electrophysiological signals, so that the actual conductive direction of the signals is better defined, and an ablation target point is quickly found. In treatment, a plurality of rectangular pulsed electric field coverage areas are formed between the center electrode and the outer electrodes. The operator can select the electrode pair for ablation according to actual needs.
As a preferred embodiment of the present invention, the annular member includes an annular member distal section, an annular member intermediate section, and an annular member proximal section that are sequentially adjacent, and the cross-sectional areas of the annular member intermediate section and the annular member proximal section are larger than the cross-sectional area of the annular member distal section.
As a preferable aspect of the present invention, a dimension of the annular member in the sheet-shaped head end plane direction is larger than a dimension perpendicular to the sheet-shaped head end plane direction, and a dimension of the intermediate ridge in the sheet-shaped head end plane direction is larger than a dimension perpendicular to the sheet-shaped head end plane direction.
Typically, the outer electrode is distributed over the intermediate annular member section or over both the intermediate annular member section and the distal annular member section, and the proximal annular member section is adapted to be secured to a catheter. The annular member intermediate section and the annular member proximal section provide support for the entire sheet-like head end, and the annular member distal section is to be conveniently folded, so that the cross-sectional area of the annular member intermediate section and the annular member proximal section is set to be greater than the cross-sectional area of the annular member distal section. Meanwhile, the annular member and the middle ridge are flat, namely, the dimension in the plane direction of the sheet-shaped head end is larger than the dimension in the plane direction perpendicular to the sheet-shaped head end, so that the movement of each electrode in the plane is reduced, and the stability of the electrode spacing is improved.
As a preferred embodiment of the present invention, the electrode is provided in a flexible printed circuit, and the flexible printed circuit is connected to the sheet-shaped terminal.
With the structure, the electrode mounting process can be simplified in the flexible printed circuit mode, the control precision of the electrode size and the distance can be improved, and particularly, the production efficiency can be improved when the number of the electrodes is large.
As a further preferable technical scheme of the invention, the flexible printed circuit comprises a conductive layer and an insulating layer, wherein the conductive layer comprises at least one layer, the insulating layer comprises at least one layer, and the electrodes are distributed on the conductive layer on the outermost layer.
As a preferred technical scheme of the invention, the cardiac electrophysiology mapping and ablation catheter further comprises an elongated tube body, a handle and a connecting tube, wherein the handle is connected with the proximal end of the tube body of the elongated tube body, the distal end of the tube body of the elongated tube body is connected with the connecting tube, and the connecting tube is connected with the sheet-shaped head end.
As a further preferable technical scheme of the invention, the proximal end of the tube body is made of harder materials, and the distal end of the tube body is made of softer materials, namely, the distal end of the tube body is softer relative to the proximal end of the tube body, so that the distal end of the tube body is easier to bend than the proximal end of the tube body.
As a further preferable technical scheme of the invention, the electrode further comprises a reference electrode, and the connecting pipe is provided with a positioning sensor and the reference electrode.
With this configuration, the position sensor is able to indicate the position and rotational direction of the sheet-like head end of the catheter, and the reference electrode is used to provide a reference for the electrode on the sheet-like head end, reducing interference of far-field signals.
As a further preferable technical scheme of the invention, a first control member is arranged on the handle, a first traction member is arranged in the slender tube body, one end of the first traction member is connected with the first control member, and the other end of the first traction member is connected with the connecting tube;
And/or the handle is provided with a second control member, a second traction member is arranged in the slender tube body, the electrode is arranged on one surface of the sheet-shaped head end, one end of the second traction member is connected with the second control member, the other end of the second traction member is connected with the far section of the annular member through the back surface of the sheet-shaped head end, and the back surface of the sheet-shaped head end is a surface without the electrode.
In summary, due to the adoption of the technical scheme, the beneficial effects of the invention are as follows:
According to the cardiac electrophysiology mapping and ablation catheter disclosed by the invention, the polarities of the central electrode and the outer electrode are different, the distribution areas are different, and sufficient space barriers are arranged between the electrodes with different polarities, so that whether high-voltage pulse electric field energy can be tolerated between the electrodes during discharge is not needed to be considered too much at the sheet-shaped head end with limited space; meanwhile, the center electrode and the outer electrode are used for mapping and ablation, so that the switching frequency of a catheter in operation is reduced, the economic burden of a patient is reduced, a high-voltage pulse electric field is used as ablation energy for tissue ablation, the ablation time is shorter, the ablation effect is more reliable, and multiple operations are not needed; the catheter has the advantages of simple structure, convenient use and good effect.
Drawings
FIG. 1 is a schematic structural view of a cardiac electrophysiology mapping and ablation catheter;
FIG. 2 is a schematic view of a sheet-like headend;
FIG. 3 is a schematic view of another construction of a sheet-form headend;
FIG. 4 is a schematic view of the structure of the annular member of FIG. 3;
FIG. 5 is an exploded view of an FPC electrode array structure;
FIG. 6 is a schematic structural view of a sheet-like headend having a second traction member;
FIG. 7 is a schematic cross-sectional view of a distal end of a tube;
Fig. 8 is a schematic cross-sectional view of another distal end of a tube.
The marks in the figure: 10-elongate tubular body, 12-tubular body proximal end, 14-tubular body distal end, 20-handle, 22-first manipulation member, 24-second manipulation member, 30-sheet-like head end, 32-annular member, 320-annular member distal section, 322-annular member proximal section, 324-annular member intermediate section, 34-intermediate ridge, 36-electrode, 360-center electrode, 362-outer electrode, 364-reference electrode, 38-electrode lead, 40-flexible circuit board, 42-insulation layer, 44-conductive layer, 50-positioning sensor, 52-positioning sensor tail, 601-first traction member, 602-second traction member, 70-connection tube.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
In the related art, on one hand, for ventricular arrhythmia, scar region tissue is a complex heterogeneous structure, the heat conduction mechanism is not clear, and the traditional radio frequency ablation catheter is adopted to perform radio frequency ablation, so that abnormal conduction paths cannot be completely blocked, and arrhythmia recurrence can be caused; on the other hand, the radio frequency ablation catheter requires long operation time, more times and low efficiency. To this end, the technical solution of the present application is explained below with reference to fig. 1 to 8.
Example 1
As shown in fig. 1-5, a cardiac electrophysiology mapping and ablation catheter according to the present invention includes a sheet-like head end 30 and an electrode 36.
As shown in fig. 1 to 3, the sheet-shaped head end 30 includes an annular member 32 and an intermediate ridge 34 located in the same plane, the intermediate ridge 34 is connected to the annular member 32, the electrode 36 includes at least one central electrode 360 and a plurality of outer electrodes 362, the polarities of the outer electrodes 362 and the central electrode 360 are opposite, the central electrode 360 is disposed on the intermediate ridge 34, the outer electrodes 362 are disposed on the annular member 32, the electrodes 36 form an array on the sheet-shaped head end 30, the annular member 32 and the intermediate ridge 34 are made of thermoplastic elastomer or shape memory alloy, and the electrodes 36 are used for collecting physiological signals or transmitting high-voltage pulse electric field energy.
Conduction of electrical signals in the heart near myocardial scar tissue is disorderly, and accurate mapping is of great importance for diagnosis of cardiac arrhythmias. During the diagnostic procedure, electrode pairs may be formed between each of the electrodes 36 to collect bipolar electrophysiological signals of the mapping region. During treatment, the central electrode 360 and any one or more of the outer electrodes 362 may be formed into an electrode pair to ablate the coverage area with a pulsed electric field. This requires only a short time to achieve ablation of a larger area.
The annular member 32 and the intermediate ridge 34 form a supporting framework for the sheet-like head end 30, and are made of a soft and resilient material, so that the sheet-like head end 30 can conform to the shape of the tissue when in contact with the tissue, deform, and quickly return to its original shape when removed from the tissue. Meanwhile, the sheet-shaped head end 30 may be contracted or curled in the direction of the central axis of the catheter to a smaller size through the sheath, and unfolded in a plane shape upon exiting the sheath. That is, the shape of the annular member 32 defines the basic contour of the sheet-like head end 30, and the annular member 32 and the intermediate ridge 34 are thermoplastic elastomers (TPE/TPR, thermoplastic Elastomer) or shape memory alloys (e.g., nitinol). In particular, when the annular member 32 and the intermediate ridge 34 are formed of a shape memory alloy, the surfaces require an insulating treatment to ensure that they do not conduct with the electrode 36 or electrode lead 38. For example, the annular member 32 and the intermediate ridge 34 may be coated with an insulating material such as polyurethane, polyether block Polyamide (PEBAX), or the like.
In a specific embodiment, as shown in fig. 1 and 2, the ring member 32 is in a circular ring shape, the electrode 36 includes one central electrode 360, the central electrode 360 is located at the center of the ring member 32, the central electrode 360 and each of the outer electrodes 362 are equally spaced to form a plurality of equidistant electrode pairs, and the outer electrodes 362 are mainly distributed on two sides of the ring member 32 opposite to the catheter axis. With this structure, the ablation area of the sheet-shaped head end 30 can be divided into a plurality of sectors according to the distribution of the outer electrodes 362, and the sectors to be ablated can be selected according to the need in the ablation process.
In a specific embodiment, the annular member 32 is polygonal, and the polygon includes two sides disposed in parallel, and the sides are parallel to the catheter axis and the middle ridge 34, as shown in fig. 3, in this embodiment, the annular member 32 is hexagonal and symmetrically disposed about the catheter axis, the middle ridge 34 is connected to two opposite vertices of the hexagon, a plurality of central electrodes 360 are disposed on the middle ridge 34 at intervals, the outer electrodes 362 corresponding to the positions of the central electrodes 360 are disposed on the sides, and the distances from the central electrodes 360 to two adjacent outer electrodes 362 are equal. With this structure, the electrode areas distributed in the transverse and longitudinal arrays are formed between the central electrode 360 and the outer electrode 362, and during diagnosis, the electrodes 36 distributed in the transverse and longitudinal arrays can simultaneously identify the electrophysiological signals conducted in the transverse and longitudinal directions, which is more beneficial to determining the actual conducting direction of the signals and finding the ablation target quickly. In treatment, a plurality of rectangular pulsed electric field coverage areas are formed between the center electrode 360 and the outer electrode 362. The operator can select the electrode pair for ablation according to actual needs.
In a specific embodiment, the annular member 32 may be configured differently from one segment to another in order to facilitate crimping or folding while providing good support to the sheet-form head end 30. As shown in fig. 4, which is a schematic view of the annular member 32 of the sheet-form head end 30 shown in fig. 3, the annular member 32 includes an annular member distal section 320, an annular member intermediate section 324, and an annular member proximal section 322 that are sequentially adjoined, the cross-sectional areas of the annular member intermediate section 324 and the annular member proximal section 322 being greater than the cross-sectional area of the annular member distal section 320. The annular member 32 has a dimension in the planar direction of the sheet-like head end 30 that is greater than a dimension perpendicular to the planar direction of the sheet-like head end 30, and the intermediate ridge 34 has a dimension in the planar direction of the sheet-like head end 30 that is greater than a dimension perpendicular to the planar direction of the sheet-like head end 30.
Typically, the outer electrode 362 is distributed over the annular member middle section 324 or over both the annular member middle section 324 and the annular member distal section 320, and the annular member proximal section 322 is adapted for securement to a catheter. The annular member intermediate section 324 and the annular member proximal section 322 provide support for the entire sheet-form head end 30, and the annular member distal section 320 is intended to facilitate folding, thus providing the annular member intermediate section 324 and the annular member proximal section 322 with a cross-sectional area that is greater than the cross-sectional area of the annular member distal section 320. Meanwhile, the ring-shaped member 32 and the middle ridge 34 are flat, that is, the dimension in the plane direction of the sheet-shaped head end 30 is larger than the dimension perpendicular to the plane direction of the sheet-shaped head end 30, so as to reduce the movement of each electrode 36 in the plane and improve the stability of the spacing between the electrodes 36.
In a specific embodiment, the electrodes 36 are provided in a flexible printed circuit, i.e. the electrodes 36 and electrode leads 38 are prepared by means of the flexible printed circuit, which is connected to the sheet-like head end 30. With this structure, the mounting process of the electrodes 36 can be simplified by the flexible printed circuit, the control accuracy of the size and pitch of the electrodes 36 can be improved, and particularly, the production efficiency can be improved when the number of the electrodes 36 is large.
Specifically, the flexible printed circuit includes a conductive layer 44 and an insulating layer 42, the conductive layer 44 includes at least one layer, the insulating layer 42 includes at least one layer, and the electrodes 36 are distributed on the outermost conductive layer 44. The electrode leads 38 may be distributed in the conductive layer 44 or other conductive layers 44 where the electrodes 36 are located, as desired. When the electrode lead 38 and the electrode 36 are in different conductive layers 44, they are typically connected by punching holes from the electrode 36 to the corresponding electrode lead 38 and filling the holes with solder.
In a specific embodiment, the electrode 36 is prepared as one or more flexible circuit boards 40 (FPCs, flexible Printed Circuit) in the manner of fig. 5, and then the flexible circuit boards 40 are engraved into the substantially same shape of the ring member 32 and the intermediate ridge 34, and then the flexible circuit boards 40 are fixed to the surfaces of the ring member 32 and the intermediate ridge 34 by means of pasting, hot pressing, or the like. The flexible circuit board 40 illustrated in fig. 5 includes two insulating layers 42, the electrode 36 is attached to a surface of one insulating layer 42 to form a conductive layer 44, the electrode wires 38 are arranged between the two insulating layers 42, that is, the electrode wires 38 form a conductive layer 44, the electrode wires 38 are arranged at intervals, the electrode wires 38 arranged at intervals when the two subsequent insulating layers 42 are connected are closed by the insulating layer 42, and holes are punched in the insulating layer 42 between the electrode wires 38 and the electrode 36 and are filled with solder to connect the electrode 36 and the corresponding electrode wires 38. Of course, more insulating layers 42 may be provided, and only one electrode wire 38 may be provided between adjacent insulating layers 42 to provide better insulating performance. In particular, for high voltage pulse ablation electrodes, there should be sufficient dielectric strength between the electrode leads 38 of different polarity. For example, sufficient distance may be maintained between the electrode leads 38 of different polarities or distributed across the different conductive layers 44.
The high voltage pulse ablates as an inter-electrode discharge, which may be one-to-one, one-to-many, or many-to-many, depending on the ablation effect desired. The surface area ratio and electrode spacing of the discharged electrode pairs can affect the ablation effect. Preferably, the surface area ratio between the discharged electrode pairs is 1-3, and the electrode spacing is 1-4 mm. The electrode 36 is made of a material with better conductivity, such as gold, silver, platinum, or copper with the surface plated with the above materials.
The electrode 36 is connected to both the high voltage pulsed electric field ablation device and the electrophysiology mapping system. The electrode 36 may be used for electrophysiological mapping in addition to pulsed ablation. An electrode pair is formed between the center electrode 360 and the outer electrode 362 for discharge during ablation. During mapping, bipolar signals may be acquired from electrode pairs that are formed between the center electrodes 360, between the outer electrodes 362, or between the center electrodes 360 and the outer electrodes 362.
In the cardiac electrophysiology mapping and ablation catheter according to this embodiment, the polarities of the central electrode 360 and the outer electrode 362 are different, the distribution areas are different, and there is enough space barrier between the electrodes 36 with different polarities, so that it is not necessary to consider whether the electrodes 36 can withstand high-voltage pulse electric field energy when the sheet-shaped head end 30 with limited space is discharged too much; meanwhile, the central electrode 360 and the outer electrode 362 are used for mapping and ablation, so that the switching frequency of a catheter in operation is reduced, the economic burden of a patient is reduced, and aiming at ablation of scar tissues, a high-voltage pulse electric field is used as ablation energy, the ablation time is shorter, the ablation effect is more reliable, and multiple operations are not needed; the catheter has the advantages of simple structure, convenient use and good effect.
Example 2
As shown in fig. 1 to 8, a cardiac electrophysiology mapping and ablation catheter according to the present invention includes an elongate body 10, a handle 20, a connection tube 70, and a sheet-like head end 30 and an electrode 36 as described in embodiment 1.
As shown in FIG. 1, the handle 20 is connected to the proximal tube end 12 of the elongated tube 10, the distal tube end 14 of the elongated tube 10 is connected to the connecting tube 70, the connecting tube 70 connects the proximal annular member segment 322 of the sheet-form head end 30 and the proximal end of the intermediate ridge 34, and the intermediate ridge 34 extends from the connecting tube 70 to the distal annular member segment 320 and is integral with the distal annular member segment 320. Wherein the proximal tube end 12 is made of a harder material, and the distal tube end 14 is made of a softer material, i.e., the distal tube end 14 is softer than the proximal tube end 12, so that the distal tube end 14 is easier to bend than the proximal tube end 12, and the handle 20 can control the bending of the distal tube end 14 or the sheet-shaped head end 30.
As shown in fig. 2 and 3, the electrode 36 further includes a reference electrode 364, and the connection tube 70 is provided with the positioning sensor 50 and the reference electrode 364. With this configuration, the position sensor 50 is able to indicate the position and rotational direction of the sheet-like tip 30 of the catheter, and the reference electrode 364 is used to provide a reference for the electrode 36 on the sheet-like tip 30, reducing interference with far-field signals. Wherein, the positioning sensor 50 adopts a magnetic positioning sensor, when the catheter is electrically connected with the matched equipment, the positioning sensor 50 is electrically connected with the matched equipment through a positioning sensor tail wire 52, the position data collected by the positioning sensor 50 is transmitted to the matched equipment, and the position of the sheet-shaped head end 30 in the patient can be seen by an operator through calculation and processing; the reference electrode 364 is a ring electrode, and the reference electrode 364 is axially disposed around the connection tube 70.
In a specific embodiment, at least one positioning sensor 50 is further mounted on the sheet-like head end 30, and the mounting position of the positioning sensor 50 is selected according to the need. Figures 2 and 3 illustrate possible mounting locations for the positioning sensor 50. When the catheter is electrically connected to the accessory, the positioning sensor 50 is electrically connected to the accessory via a positioning sensor tail 52. The position data collected by the positioning sensor 50 is transmitted to the accessory, and the position and form of the sheet-like head end 30 in the patient can be seen by the operator through calculation and processing.
In a specific embodiment, the handle 20 is provided with a first manipulation member 22, the elongated tube body 10 is provided with a first traction member 601 therein, the first traction member 601 includes a rope body, one end of the first traction member 601 is fixed on the inner wall of the connecting tube 70, the other end extends from the lumen of the elongated tube body 10 and is connected with the first manipulation member 22, and the position of the sheet-shaped head end 30 can be adjusted by manipulating the first manipulation member 22 on the handle 20 to bend the tube body distal end 14.
In a specific embodiment, although the high pressure pulse ablation is less stringent than the rf ablation in terms of placement, in practice studies have found that good placement is still an important means of improving the effectiveness of pulse ablation. As shown in fig. 6, the handle 20 is provided with a second manipulation member 24, the elongated tube body 10 is provided with a second traction member 602, the electrode 36 is disposed on one surface of the sheet-shaped head end 30, the second traction member 602 includes a rope body, one end of the second traction member 602 is connected to the second manipulation member 24, the other end of the second traction member extends from the lumen of the elongated tube body 10 and is connected to the annular member distal section 320 of the annular member 32 through the back surface of the sheet-shaped head end 30, the back surface of the sheet-shaped head end 30 is the surface on which the electrode 36 is not disposed, and the sheet-shaped head end 30 can be bent by manipulating the second manipulation member 24 on the handle 20. The second traction member 602 may control the deflection of the sheet-form head end 30 at an angle, preferably 0-120, relative to the catheter shaft. The active deflection of the catheter tip can adjust the morphology of the sheet-like tip 30 to a shape more compatible with the tissue surface, increasing the effect of the electrode 36 against the tissue, making mapping more accurate and ablation efficient.
In a specific embodiment, the elongate tubular body 10 is a multi-lumen structure housing the first traction member 601, the second traction member 602, and the electrode lead 38. The electrode lead 38 may be a conventional wire or may be formed directly from the flexible circuit board 40.
Fig. 7 illustrates a schematic cross-section of the elongated tubular body 10, wherein a central flat cavity is used to accommodate the extension of the flexible circuit board 40 and the positioning sensor tail 52, and two symmetrical small cavities are used to accommodate the first traction member 601 and the second traction member 602, respectively. If the electrode wire 38 is a wire having a conventional wire enamel extending from a portion of the body, the electrode wire 38 in the flexible circuit board 40 is preferably soldered to the wire enamel in the connection pipe 70.
Fig. 8 illustrates a schematic view of a cross section of another alternative of the elongate tubular body 10. Two symmetrical large cavities for accommodating the electrode wires 38 and the positioning sensor tails 52, wherein the electrode wires 38 of different polarities are distributed in different lumens; two small cavities are used to house the first traction member 601 and the second traction member 602, respectively.
The heart electrophysiology mapping and ablating catheter is characterized in that electrodes are prepared in a printed circuit mode, the production efficiency is high, the labor cost is low, the electrode size and the electrode spacing are controlled more accurately, the ablating depth is more uniform, and the ablating degree is easier to grasp; the plurality of control structures can flexibly control the sheet-shaped head end 30 and the tube body distal end 14 to freely move, thereby being more beneficial to tightly attaching the electrode 36 to tissues and improving the mapping accuracy and the ablation efficiency.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (7)
1.A cardiac electrophysiology mapping and ablation catheter, comprising a sheet-shaped head end (30) and an electrode (36), wherein the sheet-shaped head end (30) comprises an annular member (32) and a middle ridge (34), the middle ridge (34) is connected in the annular member (32), the electrode (36) comprises at least one central electrode (360) and a plurality of outer electrodes (362), the polarities of the outer electrodes (362) and the central electrodes (360) are opposite, the central electrodes (360) are arranged on the middle ridge (34), the outer electrodes (362) are arranged on the annular member (32), the electrodes (36) form an array on the sheet-shaped head end (30), the annular member (32) and the middle ridge (34) are made of thermoplastic elastic materials or shape memory alloys, and the electrode (36) is used for collecting physiological signals or transmitting high-voltage pulse electric field energy; the electrode (36) is arranged in a flexible printed circuit, and the flexible printed circuit is connected with the sheet-shaped head end (30);
The annular member (32) is in a circular ring shape, the electrode (36) comprises a central electrode (360), the central electrode (360) is positioned at the center of the circle of the annular member (32), and the central electrode (360) and each outer electrode (362) are arranged at equal intervals;
Or the annular member (32) is polygonal, and the polygon comprises two sides which are arranged in parallel, the sides are parallel to the axis of the catheter and the middle ridge (34), a plurality of center electrodes (360) are arranged on the middle ridge (34) at intervals, outer electrodes (362) corresponding to the positions of the center electrodes (360) are arranged on the sides, and the distances from the center electrodes (360) to the adjacent two outer electrodes (362) are equal.
2. The cardiac electrophysiology mapping and ablation catheter of claim 1, wherein the annular member (32) comprises an annular member distal segment (320), an annular member intermediate segment (324), and an annular member proximal segment (322) that are contiguous in sequence, the annular member intermediate segment (324) and the annular member proximal segment (322) having a cross-sectional area that is greater than a cross-sectional area of the annular member distal segment (320).
3. The cardiac electrophysiology mapping and ablation catheter of claim 1, wherein the annular member (32) has a dimension in a planar direction of the sheet-like head end (30) that is greater than a dimension perpendicular to the planar direction of the sheet-like head end (30), and wherein the intermediate ridge (34) has a dimension in the planar direction of the sheet-like head end (30) that is greater than a dimension perpendicular to the planar direction of the sheet-like head end (30).
4. The cardiac electrophysiology mapping and ablation catheter of claim 1, wherein the flexible printed circuit includes a conductive layer (44) and an insulating layer (42), the conductive layer (44) including at least one layer, the insulating layer (42) including at least one layer, the electrodes (36) being distributed over the outermost conductive layer (44).
5. The cardiac electrophysiology mapping and ablation catheter of any one of claims 1-4, further comprising an elongate tube (10), a handle (20), and a connection tube (70), the handle (20) being connected to a proximal tube end (12) of the elongate tube (10), a distal tube end (14) of the elongate tube (10) being connected to the connection tube (70), the connection tube (70) being connected to the sheet-like head end (30).
6. The cardiac electrophysiology mapping and ablation catheter of claim 5, wherein the electrode (36) further comprises a reference electrode (364), and wherein the connection tube (70) has a positioning sensor (50) and the reference electrode (364) disposed thereon.
7. The cardiac electrophysiology mapping and ablation catheter according to claim 5, wherein a first manipulation member (22) is provided on the handle (20), a first traction member (601) is provided in the elongated tube body (10), one end of the first traction member (601) is connected to the first manipulation member (22), and the other end is connected to the connecting tube (70);
And/or be equipped with on handle (20) and control component (24), be equipped with second traction member (602) in slender body (10), electrode (36) set up on one face of slice head end (30), second traction member (602) one end is connected control component (24), the other end is passed through the back of slice head end (30) connect in annular component distal end (320) of annular component (32), the back of slice head end (30) is the face that does not set up electrode (36).
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