WO2022001986A1 - 消融导管 - Google Patents

消融导管 Download PDF

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Publication number
WO2022001986A1
WO2022001986A1 PCT/CN2021/102849 CN2021102849W WO2022001986A1 WO 2022001986 A1 WO2022001986 A1 WO 2022001986A1 CN 2021102849 W CN2021102849 W CN 2021102849W WO 2022001986 A1 WO2022001986 A1 WO 2022001986A1
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WO
WIPO (PCT)
Prior art keywords
ablation
ring
mapping
segment
handle
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PCT/CN2021/102849
Other languages
English (en)
French (fr)
Inventor
唐闽
刘成
王永胜
Original Assignee
杭州德诺电生理医疗科技有限公司
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Publication of WO2022001986A1 publication Critical patent/WO2022001986A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to an ablation catheter for cardiac ablation.
  • Atrial fibrillation is the most common sustained cardiac arrhythmia.
  • the incidence of atrial fibrillation increases with age, reaching 10% of people over the age of 75.
  • the frequency of atrial excitation is 300 to 600 beats per minute, and the heart rate is often fast and irregular, sometimes reaching 100 to 160 beats per minute. contraction function.
  • Atrial fibrillation often increases the risk of acquiring many potentially fatal complications, including thromboembolic stroke, dilated cardiomyopathy, and congestive heart failure.
  • Common atrial fibrillation symptoms such as palpitations, chest pain, dyspnea, fatigue, and dizziness can also affect life quality. Compared with normal people, people with atrial fibrillation had an average five-fold increased incidence and three-fold increased mortality.
  • Tissue ablation is commonly used to treat a variety of cardiac arrhythmias, including atrial fibrillation.
  • the principle of tissue ablation therapy is to place an electrode catheter into the cardiac cavity by puncturing the femoral artery or femoral vein, determine the source of the cardiac arrhythmia with the help of a mapping guide wire, and then guide the ablation catheter to ablate and block the target tissue area.
  • a mapping guide wire it is also necessary to use a mapping guide wire to monitor whether the electrophysiological signal in the target tissue area has been isolated. Therefore, the ablation treatment cannot be completed by guiding the ablation catheter into the cardiac cavity alone. It is also necessary to guide the mapping guide wire into the cardiac cavity.
  • the two devices, the ablation catheter and the mapping guide wire need to be guided and operated respectively, which leads to the operation steps. Complicated, long operation time and high cost.
  • An ablation catheter includes a handle and a bearing rod connected to the distal end of the handle, the bearing rod includes a mapping ring and an ablation ring arranged at the distal end of the bearing rod, the ablation ring is located between the mapping ring and the ablation ring Between the handles, both the mapping ring and the ablation ring are annular and extend around the axis of the bearing rod, the mapping ring is provided with a mapping electrode, and the ablation ring is provided with an ablation electrode, The ablation electrode is used to deliver ablation energy to the target tissue area, and the mapping electrode is used to transmit electrophysiological signals in the target tissue area to the handle.
  • the radial dimension of the ablation ring is greater than or equal to the radial dimension of the mapping ring.
  • the bearing rod includes a proximal end segment connected between the handle and the ablation ring, and the ablation ring, the mapping ring and the proximal end segment are integrally formed structures.
  • the carrying rod further includes a connecting section connected between the ablation ring and the mapping ring, the connecting section includes a first section and a second section, and the second section is connected to the Between the first section and the mapping ring, the end of the second section connecting the first section is opposite to the end connecting the mapping ring, and the distance from the geometric center of the mapping ring is closer; and/or
  • the proximal segment includes a fourth segment connected between the fourth segment and the ablation ring, and a fifth segment connected to the fourth region One end of the segment is closer to the geometric center of the ablation ring than the end where it connects to the mapping ring.
  • connection between the proximal end segment and the ablation ring, and the connection between the connection segment and the ablation ring and the mapping ring are respectively provided with arc transitions.
  • the ablation ring is formed in a first plane
  • the mapping ring is formed in a second plane.
  • first plane and/or the second plane are perpendicular to the axis of the bearing rod.
  • the number of the mapping electrodes is multiple, and the multiple mapping electrodes are arranged at intervals along the circumference of the mapping ring; and/or, the number of the ablation electrodes is multiple, and the positive electrode among the multiple ablation electrodes is The negative electrodes are alternately arranged.
  • the ablation ring includes a first ablation ring and a second ablation ring
  • the second ablation ring is disposed at the proximal end of the first ablation ring relative to the handle, the first ablation ring and the Both the second ablation rings are provided with ablation electrodes.
  • the radial dimension of the second ablation ring is larger than the radial dimension of the first ablation ring.
  • the ablation catheter further includes a connection section fixed on the handle, the connection section includes a detection interface electrically connected with the mapping ring, and an energy supply interface electrically connected with the ablation ring.
  • the ablation catheter is provided with an inner sheath tube between the bearing rod and the handle, the inner sheath tube is provided with a traction member along the axial direction, and the traction member is connected to the inner sheath Between the distal end of the tube and the handle, the handle bends the distal end of the inner sheath tube in one direction by pulling the traction member.
  • the ablation catheter provided by the present application is provided by simultaneously arranging the mapping ring and the ablation ring at the distal end of the carrying rod, and the mapping ring is provided with a detection target tissue for detecting the target tissue.
  • a mapping electrode for electrophysiological signals in a region the ablation ring is provided with an ablation electrode for delivering ablation energy to the target tissue region, so that the ablation catheter has both the mapping function and the ablation function. Therefore, the integral integration of the ablation ring and the mapping ring makes the surgical operation more convenient, which is beneficial to improve the success rate of the operation.
  • FIG. 1 is a schematic structural diagram of the ablation catheter provided by the first embodiment of the present application.
  • Fig. 2 is a partial structural schematic diagram of the ablation catheter in Fig. 1;
  • FIG. 3 is a schematic structural diagram of the ablation catheter shown in FIG. 2 after bending;
  • Fig. 4 is the internal structure schematic diagram of the inner sheath shown in Fig. 3;
  • Fig. 5 is the internal structure schematic diagram of the traction member shown in Fig. 4;
  • FIG. 6 is a cross-sectional view of the handle shown in FIG. 1 along line VI-VI;
  • FIG. 7 is a schematic diagram of the partial structure of the ablation catheter provided by the second embodiment of the present application.
  • proximal end the end close to the operator
  • distal end the end away from the operator
  • This definition is only for the convenience of expression, and should not be construed as a limitation on the present application.
  • Axial refers to the axial direction of the bearing rod or the axial direction of the handle.
  • FIG. 1 is a schematic structural diagram of the ablation catheter 100 provided by the first embodiment of the application.
  • the ablation catheter 100 provided in the present application is used for cardiac ablation, such as tissue ablation of pulmonary veins, left atrial appendages, and ventricles.
  • the ablation catheter 100 includes a handle 10, an inner sheath tube 50 and a bearing rod 20, wherein the distal end of the handle 10 is fixedly connected with the proximal end of the inner sheath tube 50, and the distal end of the inner sheath tube 50 is fixedly connected with the proximal end 201 of the bearing rod 20 , the distal end 202 of the carrying rod 20 also extends along its own axis 203 in a direction away from the handle 10 .
  • the central axis 203 is the central axis of the bearing rod 20 , and coincides with the central axis of the inner sheath tube 50 and the central axis of the handle 10 .
  • the central axis of the carrying rod 20 is not limited, and coincides with the central axis of the inner sheath tube 50 and the central axis of the handle 10 .
  • the bearing rod 20 includes a proximal end section 21, the proximal end section 21 includes a proximal end 201, and the proximal end section 21 is a rod-like structure.
  • the distal end 202 of the carrier rod 20 is also provided with a mapping ring 40 and an ablation ring 30 at intervals, and the ablation ring 30 is located between the mapping ring 40 and the handle 10 .
  • the mapping ring 40 and the ablation ring 30 are both substantially annular as a whole, and both the mapping ring 40 and the ablation ring 30 extend in an annular rotation around the direction of the axis 203 of the bearing rod 20 .
  • the axes of the mapping ring 40 and the ablation ring 30 are coincident with each other.
  • the mapping ring 40 is used to enter the pulmonary vein or the left atrial appendage, and make a circle with the inner wall of the lumen. Fitting, so that the axis of the ablation ring 30 is aligned with the center of the mouth of the pulmonary vein or the mouth of the left atrial appendage, so that the ablation ring 30 can surround the mouth of the pulmonary vein or the mouth of the left atrial appendage for ablation.
  • Another application scenario is that the mapping ring 40 and the ablation ring 30 are used to ablate tissue in the ventricle.
  • pulmonary vein ablation is used as an example for description. It is understood that the ablation catheter 100 is also used to ablate other tissues in the heart.
  • the axes of the mapping ring 40 and the ablation ring 30 are parallel to each other.
  • the mapping ring 40 is provided with a mapping electrode 41, and the mapping ring 40 detects the electrophysiological signal in the target tissue area through the mapping electrode 41 to achieve the mapping function. Specifically, when the mapping ring 40 is attached to the pulmonary vein When the target tissue is on the inner wall, the ablation catheter 100 can perform electromyography (electromyography, EMG) intracardiac signal detection through the mapping electrode 41 on the mapping ring 40 .
  • the ablation ring 30 is provided with an ablation electrode 31, and the ablation electrode 31 is used to deliver ablation energy to the target tissue region.
  • the ablation ring 30 and the mapping ring 40 are spaced apart, when the mapping ring 40 is attached to the target tissue area, the ablation ring 30 can use the ablation electrode 31 to transmit pulse energy, radio frequency energy or other energy sources, etc. ablation.
  • the ablation energy of the ablation ring 30 can be controlled so that the ablation energy emitted by the ablation energy can block at least part of the tissue in the target tissue area.
  • the electrophysiological signals generated in the target area are different, and the response thresholds of different tissues to ablation energy are different, so the ablation ring 30 can be individually isolated for the target tissue that emits undesired electrophysiological signals in the target tissue area, so as to avoid influence The normal work of the rest of the organization. After ablation, the electrophysiological signals generated in the target tissue area meet expectations and achieve the purpose of eliminating atrial fibrillation.
  • the ablation catheter 100 of the present application can perform the mapping operation and the ablation operation on the target tissue, and the mapping and ablation operations can be performed simultaneously or in a time-sharing manner.
  • the ablation catheter 100 of the present application simplifies the operation steps of the operation, makes the operation process more convenient, and is also conducive to improving the success of the operation. Rate.
  • annular mapping ring 40 has a first radial dimension
  • annular ablation ring 30 has a second radial dimension
  • the second radial dimension is greater than or equal to the first radial dimension.
  • the ablation energy source is pulse
  • the ablation ring 30 can ablate the target tissue along its radial direction in a non-contact manner. diverge. Setting the second radial dimension of the ablation ring 30 to be greater than or equal to the first radial dimension of the mapping ring 40 is beneficial for the ablation ring 30 to form an ablation area around the ostium outside the pulmonary vein, thereby adapting to the anatomical structure of the pulmonary vein ostium.
  • the bearing rod 20 includes the proximal end segment 21 , the ablation ring 30 and the mapping ring 40 in sequence along the direction of its own axis 203 , and the ablation ring 30 , the mapping ring 40 and the proximal end segment 21 are integrally formed. It can be understood that when the ablation ring 30 , the mapping ring 40 and the proximal end segment 21 are integrally formed, the distal end 202 of the carrier rod 20 will rotate and bend around the axis 203 to form the ablation ring 30 and the mapping ring 40 successively.
  • the carrier rod 20 needs to be conveyed and guided through an outer sheath tube (not shown in the figure) sleeved on the outside of the carrier rod 20 to reach the heart position.
  • the integrally formed carrier rod 20 is linearly accommodated in the outer sheath tube during the delivery process. Its diameter can be contracted to a smaller state to facilitate its delivery in the outer sheath, which facilitates the use of a smaller diameter outer sheath.
  • the carrier rod 20 When the carrier rod 20 is released in the heart, it can automatically expand to the shape shown in FIG. 1 , forming a spaced ablation ring 30 and a mapping ring 40 to perform mapping and ablation operations of the ablation catheter 100 .
  • the carrier rod 20 further includes a connecting section 23 connected between the ablation ring 30 and the mapping ring 40 to realize the ablation ring 30 and the mapping ring 40 interval setting.
  • the connecting segment 23 includes a first segment 231 and a second segment 232, wherein the first segment 231 is connected to the proximal end of the second segment 232, and the second segment 232 is connected to the first segment 231 and the mapping ring 40 between.
  • the second section 232 includes one end 232a connected to the mapping ring 40 and one end 232b connected to the first section 231 .
  • the one end 232b of the second section 232 connected to the first section 231 is opposite to its end 232a connected to the mapping ring 40 , the distance from the geometric center of the mapping ring 40 is closer.
  • the thrust on the handle 10 drives the connecting segment 23 and the mapping ring 40 to move into the pulmonary vein.
  • the section 231 is connected to one end 232b of the second section 232 that is closer to the geometric center of the mapping ring 40, that is, the first section 231 is not connected to the circumferential edge of the mapping ring 40, so it does not come into contact with the pulmonary veins. It is beneficial to improve the flexibility of the movement of the mapping ring 40, and the mapping ring 40 can easily and smoothly enter the pulmonary vein.
  • the first section 231 in the connecting section 23 is connected to the circumferential edge of the mapping ring 40, in the case that the mapping ring 40 abuts against the pulmonary vein orifice tissue, the first section 231 continues to push the mapping
  • the ring 40 is easy to directly apply a thrust to the tissue area, that is, applying pressure to press the mapping ring 40 against the tissue, it is more difficult for the mapping ring 40 to slide into the pulmonary vein.
  • the mapping ring 40 When a part of the edge of the mapping ring 40 abuts on the pulmonary vein oral tissue, and the distal end of the first section 231 of the connecting segment 23 points to the mouth, the mapping ring 40 can easily enter the pulmonary vein. Further, in the embodiment of FIG. 1 , the first section 231 extends along the direction of the axis 203 . When the first section 231 points to the edge of the pulmonary vein mouth, the mapping ring 40 can easily enter the pulmonary vein.
  • the first section 231 extends in the axial direction, and passes through the geometric center of the ablation ring 30 and the mapping ring 40 in the axial direction.
  • the geometric center of the ablation ring 30 and the geometric center of the mapping ring 40 The center is not collinear with the axis 203 .
  • the first section 231 extends parallel to the axis 203 .
  • the first section 231 is inclined relative to the axial direction, such as an acute angle or an obtuse angle.
  • the second section 232 extends at least in the radial direction. In a modified embodiment, the second section 232 extends in both the axial and radial directions, and the position on the second section 232 that is closer to the proximal end is closer to the geometric center of the mapping ring 40 .
  • the connecting section 23 further includes a third section 233 connected between the ablation ring 30 and the first section 231 . Because the first section 231 extends along the axis 203 , which passes through the geometric center of the ablation ring 30 , the third section 233 connects between the geometric center and the edge of the ablation ring 30 .
  • the arrangement of the third section 233 is beneficial to ensure the position of the first section 231 relative to the mapping ring 40 and the ablation ring 30 , so that the relative displacement between the ablation ring 30 and the mapping ring 40 is not easy to occur, thereby improving the bearing member 20 in the Smooth shape of post-release movement and precise positioning in body tissue.
  • the third section 233 extends in the radial direction, and one end thereof is at the geometric center of the ablation ring 30 .
  • the third section 233 extends in the axial and radial directions, that is, the third section The 233 extends for a predetermined length in both the axial direction and the radial direction, and the third section 233 may not pass through the geometric center of the ablation ring 30 .
  • the proximal section 21 includes a fourth section 211 and a fifth section 212 , the fourth section 211 is connected between the handle 10 and the fifth section 212 , and more specifically, the fourth section 211 It is connected between the inner sheath 50 and the fifth section 212 , and the fifth section 212 is connected between the fourth section 211 and the ablation ring 30 .
  • One end 212b of the fifth section 212 connected to the fourth section 211 is closer to the geometric center of the ablation ring 30 than the end 212a of the fifth section 212 connected to the ablation ring 30 .
  • the fourth section 211 extends in the direction of the axis 203 .
  • the fourth section 211 is coaxial with the first section 231 in the connecting section 23 and extends along the axis 203, which is conducive to the uniform force of the ablation ring 30 and the mapping ring 40, and the smooth advancement of the ablation ring 30 and the mapping ring 40.
  • the probability of relative deformation of the two rings during the propulsion process is also reduced.
  • the fourth section 211 is disposed parallel to the axis 203, or the included angle formed with the axis 203 is an obtuse angle or an acute angle.
  • both the ablation ring 30 and the mapping ring 40 have an open-loop structure, so that the ablation ring 30 , the mapping ring 40 , the connecting segment 23 and the proximal end segment 21 can be integrally formed.
  • the carrying rod 20 is linearly accommodated in the outer sheath tube, and the integral molding of the carrying rod 20 is assembled from multiple sections relative to the carrying rod, omitting one of the multiple sections arranged on the carrying rod 20
  • the connecting joint between the two is beneficial to reduce the maximum outer diameter of the bearing rod 20, facilitate the use of a smaller diameter outer sheath, facilitate the loading, transportation and retraction of the bearing member 20, and improve the safety and reliability of the bearing rod 20. sex.
  • the ablation ring 30 , the mapping ring 40 and the proximal end segment 21 are not limited to be integrally formed, nor are the ablation ring 30 , the mapping ring 40 , the connecting segment 23 and the proximal end segment 21 integrally formed.
  • connection between the proximal end segment 21 and the ablation ring 30 and the connection between the connection segment 23 and the ablation ring 30 and the mapping ring 40 are respectively provided with arc transitions.
  • the connection structure of the arc transition can reduce the stress concentration phenomenon of the integrally formed bearing bar 20 at the turning position, and prevent the bearing bar 20 from being cracked or broken during the process of bending and forming the ablation ring 30 and the mapping ring 40.
  • the risk of scratching and stabbing tissue by the carrier bar 20 is also reduced.
  • arc transition can also be set.
  • FIG. 2 is a partial schematic diagram of the mapping ring 40 and the ablation ring 30 in the ablation catheter 100 of the present application.
  • the annular ablation ring 30 is formed in the first plane 101 to facilitate the formation of an annular ablation area at the mouth of the pulmonary vein;
  • the annular mapping ring 40 is formed in the second plane 102 to facilitate the mapping ring 40 Enter into the pulmonary veins and abut against the inner wall of the pulmonary veins, so that the ablation ring 30 is positioned at the mouth of the pulmonary veins and aligned with the center of the pulmonary veins
  • the first plane 101 is set perpendicular to the axis 203 of the bearing rod 20
  • the second plane 102 is perpendicular to the bearing rod 20.
  • Axis 203 is provided.
  • the first plane 101 or the second plane 102 is disposed perpendicular to the axis 203 of the bearing bar 20 , and in another modified embodiment, the first plane 101 and the second plane 102 are not parallel, and/or the first plane 101 Or the second plane 102 is not perpendicular to the axis 203 .
  • the first plane 101 is arranged parallel to the second plane 102 , so that the distance between any position on the ablation ring 30 and the corresponding position on the mapping ring 40 is equal, that is, it is arranged perpendicular to the first plane 101 and the second plane 102
  • the distances between the arbitrary planes and the intersection of the ablation ring 30 and the mapping ring 40 are respectively equal, so that the ablation energy output by the ablation ring 30 can be controlled according to the detection result of the mapping ring 40 .
  • both the first plane 101 and the second plane 102 are set to be perpendicular to the axis 203 of the bearing rod 20 , which facilitates the positioning of the mapping ring 40 and the ablation ring 30 by the handle 10 during the operation.
  • the annular ablation ring 30 is formed in the first plane 101
  • the annular mapping ring 40 is formed in the second plane 102
  • the first plane 101 is disposed perpendicular to the axis 203 of the bearing rod 20
  • the second plane 102 is arranged perpendicular to the axis 203 of the carrier bar 20 .
  • mapping electrodes 41 there are multiple mapping electrodes 41 on the mapping ring 40 , and the multiple mapping electrodes 41 are arranged at intervals along the circumferential direction of the mapping ring 40 .
  • a plurality of mapping electrodes 41 are evenly spaced and arranged along the circumference of the mapping ring 40 .
  • the multiple mapping electrodes 41 can collect electrophysiological signals from the target tissue region from multiple directions, which is beneficial to quickly and accurately locating the lesion.
  • the number of the ablation electrodes 31 is also multiple, and the multiple ablation electrodes 31 are also arranged on the ablation ring 30 at intervals along the circumferential direction thereof.
  • a plurality of ablation electrodes 31 are evenly spaced and arranged along the circumference of the ablation ring 30 .
  • the multiple ablation electrodes 31 can emit ablation energy from multiple directions, so that the ablation energy emitted by the ablation ring 30 forms a ring shape, which effectively acts on the target tissue area to isolate the lesion.
  • the ablation catheter 100 of the present application uses pulsed energy for ablation.
  • the ablation of pulsed energy is the use of high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field. Shen effect.
  • the high-voltage pulse sequence produces less heat and does not require saline flushing and cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombosis.
  • the treatment time of pulse ablation is short, usually the treatment time of applying a group of pulse sequences is less than 1 minute, and the whole ablation time is usually not more than 5 minutes. Due to the differences in the response thresholds of different target tissues to the pulsed electric field, the ablation of the myocardium can not interfere with other adjacent tissues, and avoid accidental injury to the esophagus and phrenic nerve tissues adjacent to the pulmonary vein.
  • pulse ablation does not require heat conduction to ablate deep tissues, and all cardiomyocytes distributed within the range of the pulse electric field intensity emitted by the ablation ring 30 will undergo electroporation, which reduces the adhesion of the ablation catheter 100 to the target tissue during ablation. depend on pressure requirements. That is, after the ablation catheter 100 of the present application enters the atrium, it is not necessary to completely fit the ablation ring 30 to the inner wall of the target tissue. After the ablation is completed, the intracardiac electrophysiological signal can also be monitored in time through the mapping ring 40 to determine whether the target tissue has been completely electrically isolated.
  • the multiple ablation electrodes 31 distributed on the ablation ring 30 also need to be arranged with positive and negative electrodes alternately arranged to ensure that the pulsed energy passes through the multiple ablation electrodes 31 to generate a closed-loop damage area.
  • the inner sheath tube 50 is a hollow tubular shape, and the distal end 202 of the inner sheath tube 50 is provided with a curved section 51 , and the curved section 51 can be bent.
  • the bending section 51 is made of elastic material, and the hardness of the bending section 51 is smaller than the hardness of other sections in the inner sheath tube 50, so as to facilitate bending.
  • the setting of the curved section 51 can be precisely controlled to the specific position where the inner sheath tube 50 is deformed during bending, so as to avoid the relative deformation of the mapping ring 40 and the ablation ring 30 , thereby affecting the ablation effect of the ablation catheter 100 .
  • At least one traction member 52 is provided in the tube wall of the inner sheath tube 50 along the direction of the axis 203 . Both ends of the pulling member 52 are respectively connected to the distal end of the curved section 51 and the handle 10 .
  • the traction member 52 is fixedly connected to the distal end of the curved section 51, and the handle 10 is provided with an adjustment knob 11 that is connected to the traction member 52 and can pull the traction member 52.
  • the bent inner sheath 50 can adjust the orientation of the mapping ring 40 and the ablation ring 30 so that the mapping ring 40 can be turned into the target lumen, and the ablation ring 30 is close to the target tissue area for mapping and ablation.
  • the pulling member 52 includes a pulling tube 521 and a pulling wire 522 .
  • the traction tube 521 is in the shape of a hollow tube, and its inner cavity is used for passing the traction wire 522 .
  • the pulling wire 522 can be a stainless steel wire.
  • the pulling wire 522 is a stainless steel wire covered with a coating, and its surface is smooth and has good controllability.
  • the traction tube 521 can be a spring coil, and the spring coil is wrapped with stainless steel wire, which can keep the inner sheath tube 50 smoothly adjusted.
  • the pulling tube 521 is omitted from the pulling member 52, that is, the pulling member 52 is a pulling wire.
  • two traction members 52 are oppositely disposed in the tube wall of the inner sheath tube 50 , and the two traction members 52 are pulled by the rotation of the adjustment knob 11 ( FIG. 1 ) to control the direction of the curved section 51 to two opposite directions.
  • the direction is curved, and such arrangement enables the distal end of the ablation catheter 100 to be flexibly turned toward two directions, which improves the operability and convenience of use of the ablation catheter 100 .
  • the number of the traction members 52 may be more than two, so that the curved section 51 of the inner sheath tube 50 can be bent in multiple directions.
  • the handle 10 includes a housing 111 , an adjusting member 152 disposed in the housing 111 , and a driving member 154 for driving the adjusting member 152 to move in the axial direction of the inner sheath 50 .
  • the inner sheath tube 50 is axially slidably placed in the tube wall of the inner sheath tube 50 , and a winding portion 1115 is provided in the casing 111 .
  • the distal ends of the two pulling wires 522 are connected to the distal end of the curved section 51 ( FIG.
  • the proximal end of one pulling wire 522 is connected to the adjusting member 152
  • the proximal end of the other pulling wire 522 is connected to the winding portion 1115 .
  • Adjustment member 152 Specifically, the distal end of one pulling wire 522 is fixed to the distal end of the curved section 51 , the proximal end of one pulling wire 522 is directly connected to the adjusting member 152 ; the distal end of the other pulling wire 522 is fixed to the distal end of the bending section 51 . At the distal end, the proximal end of the other pulling wire 522 is connected to the adjusting member 152 after bypassing the wire winding portion 1115 .
  • the outer wall of the driving member 154 is circumferentially fixed with the adjusting knob 11 , and the rotation of the adjusting knob 11 drives the rotation of the driving member 154 .
  • the rotation of the driving member 154 drives the adjusting member 152 to move through its internal thread and drives the two pulling wires 522 to slide, so that the curved sections 51 of the sheath tube 23 are bent in different directions, that is, the curved sections 51 can be bent in different directions and elastically reset.
  • the driving member 154 When adjusting the inner sheath tube 50, the driving member 154 is rotated by operating the adjusting knob 11, so as to drive the adjusting member 152 to rotate and move axially toward the proximal end or the distal end.
  • the adjusting member 152 rotates toward the proximal end and moves axially, the pulling wire 522 directly fixed on the adjusting member 152 is driven to slide toward the proximal end, so that the curved section 51 is bent toward the side of the pulling wire 522 under tension.
  • the traction wire 522 connected to the adjusting member 252 after bypassing the winding portion 1115 is pulled to the distal end by the deformation of the bending section 51, so that the bending section 51 completes the bending; in the initial state
  • the traction wire 522 connected to the adjusting member 152 after bypassing the winding portion 1115 is driven by the adjusting member 152 to slide toward the proximal end, so that the curved section 51 is pulled toward the tensioned portion.
  • One side of the wire 256 is bent, and the bending section 51 will drive the traction wire 522 directly fixed on the adjusting member 152 to slide toward the distal end during the bending process, so that the bending section 51 is bent.
  • the initial state means that the curved section 51 of the inner sheath tube 50 is in a straight state.
  • the ablation catheter 100 of the present application further includes a connector 60 connected to the handle 10 .
  • the connector 60 is connected to the proximal position of the handle 10
  • the connector 60 includes a detection interface 61 and an energy supply interface 62 .
  • the detection interface 61 is electrically connected to the mapping electrodes 41 on the mapping ring 40 for receiving electrophysiological signals detected by the mapping ring 40 .
  • the energy supply interface 62 is electrically connected to the ablation electrode 31 on the ablation ring 30 for transferring external energy to the ablation ring 30 for ablation.
  • the energy supply interface 62 is used to connect external pulse energy, radio frequency energy or microwave energy.
  • the inner sheath tube 50 is in the shape of a hollow tube, and a plurality of wires 24 are arranged therein, and the wires 24 are insulated from each other.
  • the detection interface 61 is connected to a plurality of mapping electrodes 41 distributed on the mapping ring 40 through the wire 24, and the electrophysiological signal detected by each mapping electrode 41 is transmitted to the detection interface 61 through a wire 24, and then the detection interface 61 transmits the electrophysiological signal to the external detection instrument; the energy supply interface 62 conducts with a plurality of ablation electrodes 31 distributed on the ablation ring 30 through the wire 24 different from the detection interface 61, and the energy supply interface 62 receives external energy and transmits it to the ablation ring 30. It is transmitted to each ablation electrode 31, so that the ablation electrode 31 forms ablation energy based on external energy, and acts on the target tissue area.
  • the ablation ring 70 includes two sub-ablation rings, namely the first ablation ring 701 and the ablation ring 70 .
  • the second ablation ring 702 and the first ablation ring 701 are disposed between the second ablation ring 702 and the mapping ring 40 .
  • the first ablation ring 701 and the second ablation ring 702 are further provided with ablation electrodes 71 at intervals, respectively, and the first ablation ring 701 and the second ablation ring 702 respectively have the function of emitting ablation energy.
  • the ablation catheter 100 of the present application can pass Two spaced sub-ablation rings were set up to cover a larger area of the ablation range.
  • the ablation catheter 100 of the present application can control different sub-ablation rings to emit ablation energy to act on different target tissue areas. Electrical isolation; or control two sub-ablation rings to emit ablation energy at the same time, to provide greater ablation energy and shorten the operation time.
  • the number of sub-ablation rings of the ablation catheter 100 may be more than two, so as to further expand the scope of action of the ablation ring 70 .
  • part of the electrodes 71 in the first ablation ring 701 and part of the electrodes in the second ablation ring 702 are turned on at the same time to ablate a designated area.
  • the radial dimension of the second ablation ring 702 is larger than the radial dimension of the first ablation ring 701 .
  • Different radial dimensions of the two sub-ablation rings can form different ablation energy ranges.
  • the radial size of the sub-ablation ring on the side closer to the target ring 40 is smaller, so that the radial size of the annular structure formed by the ablation catheter 100 of the present application at the distal position is gradually reduced, which can be adjusted according to the target vascular tissue.
  • the ablation electrode 71 on the first ablation ring 701 is selected to be turned on, and the ablation electrode 71 on the second ablation ring 702 is turned off.
  • the electrode 71 uses the first ablation ring 701 to be close to the mouth of the pulmonary vein for ablation; when the patient's pulmonary vein is wide, the first ablation ring 701 can enter the interior of the pulmonary vein, and the ablation electrode 71 on the second ablation ring 702 is selected to be turned on, and the first ablation ring 702 is turned off.
  • the ablation electrode 71 on the first ablation ring 701 uses the second ablation ring 702 to be close to the mouth of the pulmonary vein for ablation, so as to achieve better fit and ablation to the target tissue.
  • the carrying rod is provided with a sixth section 234 between the first ablation ring 701 and the second ablation ring 702 , and the sixth section 234 can be arranged in a direction parallel to or coincident with the axis, or at an acute or obtuse angle with the axis
  • the two ends of the sixth section 234 can also be provided with other connecting sections for connecting the first ablation ring 701 and the second ablation ring 702, so that the sixth section 234 is conducive to pushing the first ablation ring 701 and mapping Movement of the ring 40 in the venous vessel.

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Abstract

一种消融导管（100），包括手柄（10）以及连接于手柄（10）远端的承载杆（20）。承载杆（20）包括设置于远端（202）的标测环（40）和消融环（30），且消融环（30）位于标测环（40）和手柄（10）之间。标测环（40）与消融环（30）均呈环形，并围绕承载杆（20）的轴线延伸。标测环（40）上设置有标测电极（41），消融环（30）上设置有消融电极（31），消融电极（31）用于向目标组织区域传递消融能量，标测电极（41）用于将目标组织区域中的电生理信号传输至手柄（10）。消融导管（100）将消融环（30）和标测环（40）集成于一体，使得消融导管（100）同时具备对目标组织的电生理信号进行检测，以及对目标组织进行消融的功能，使得手术操作更加便捷，有利于提高手术的成功率。

Description

消融导管
本申请要求于2020年06月29日提交的中国国家申请、申请号为“202021231348.9”、申请名称为“消融导管”的实用新型申请的优先权。
技术领域
[根据细则91更正 29.06.2021]　
本申请涉及医疗器械技术领域，尤其涉及一种用于心脏消融的消融导管。
背景技术
心房颤动(atrial fibrillation，AF)简称房颤，是最常见的持续性心律失常，随着年龄的增长，房颤发生率不断增加，75岁以上人群可达10％。房颤时心房激动的频率达300～600次/分，心跳频率往往快而且不规则，有时候可达100～160次/分，不仅比正常人心跳快得多，而且不整齐，心房失去有效的收缩功能。房颤通常增加了获得许多潜在致命并发症的风险，包括血栓栓塞性中风、扩张性心肌病和充血性心力衰竭，常见的房颤症状如心悸、胸痛、呼吸困难、疲劳和头晕也会影响生活质量。与正常人相比，患有房颤的人平均发病率增加了五倍，死亡率增加了两倍。
组织消融通常用于治疗各种心律失常，其中就包括心房颤动。组织消融治疗的原理是经股动脉或股静脉穿刺放置电极导管至心腔内，借助标测导丝确定心脏心律失常的病灶来源，再引导消融导管对目标组织区域进行消蚀阻断。并且在消融治疗的过程中，还需要利用标测导丝监测目标组织区域中的电生理信号是否已被隔离。因此，单独引导消融导管至心腔内无法完成消融治疗，还需要引导标测导丝进入心腔内，在手术过程中需要分别引导操作消融导管与标测导丝两个设备，导致手术操作步骤复杂、手术时间长、成本高等。
[根据细则91更正 29.06.2021]发明内容
[根据细则91更正 29.06.2021]本申请的目的在于克服现有技术的不足，提供一种集消融和标测于一体的消融导管，具体包括如下技术方案：
一种消融导管，包括手柄以及连接于所述手柄远端的承载杆，所述承载杆包括设置于其远端的标测环和消融环，所述消融环位于所述标测环和所述手柄之间，所述标测环与所述消融环均呈环形，并围绕所述承载杆的轴线延伸，所述标测环上设置有标测电极，所述消融环上设置有消融电极，所述消融电极用于向目标组织区域传递消融能量，所述标测电极用于将目标组织区域中的电生理信号传输至所述手柄。
其中，所述消融环的径向尺寸大于或等于所述标测环的径向尺寸。
其中，所述承载杆包括连接于所述手柄与所述消融环之间的近端段，所述消融环、所述标测环和所述近端段为一体成型结构。
其中，所述承载杆还包括连接在所述消融环与所述标测环之间的连接段，所述连接段包括第一区段和第二区段，所述第二区段连接于所述第一区段与所述标测环之间，所述第二区段连接所述第一区段的一端相对于其连接所述标测环的一端，距离所述标测环的几何 中心的距离更近；及/或
所述近端段包括第四区段和第五区段，所述第五区段连接于所述第四区段与所述消融环之间，所述第五区段连接所述第四区段的一端相对于其连接所述标测环的一端，距离所述消融环几何中心的距离更近。
其中，所述近端段与所述消融环之间的连接处，以及所述连接段分别与所述消融环和所述标测环之间的连接处均设有圆弧过渡。
其中，所述消融环形成于第一平面内，所述标测环形成于第二平面内。
其中，所述第一平面及/或所述第二平面垂直于所述承载杆的轴线。
其中，所述标测电极数量为多个，多个标测电极沿所述标测环的周向上间隔设置；及/或，所述消融电极的数量为多个，多个消融电极中的正负电极交替排列。
其中，所述消融环包括第一消融环和第二消融环，且所述第二消融环相对于所述手柄设置于所述第一消融环的近端，所述第一消融环和所述第二消融环上均设置有消融电极。
其中，所述第二消融环的径向尺寸大于所述第一消融环的径向尺寸。
其中，所述消融导管还包括固定于所述手柄上的连接段，所述连接段包括与所述标测环电连接的检测接口，以及与所述消融环电连接的供能接口。
其中，所述消融导管在所述承载杆与所述手柄之间设置有内鞘管，所述内鞘管的管壁内沿轴向设有牵引件，所述牵引件连接在所述内鞘管的远端和所述手柄之间，所述手柄通过牵拉所述牵引件以使得所述内鞘管的远端向一个方向弯曲。
[根据细则91更正 29.06.2021]本申请提供的消融导管通过在所述承载杆的远端同时设置所述标测环和所述消融环，且所述标测环上设置有用于检测目标组织区域中电生理信号的标测电极，所述消融环上设置有用于向目标组织区域传递消融能量的消融电极，使得所述消融导管同时具备了标测的功能和消融的功能。因此，所述消融环和所述标测环的一体集成使得手术操作更加便捷，有利于提高手术的成功率。
附图说明
[根据细则91更正 29.06.2021]为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本实用新型一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
[根据细则91更正 29.06.2021]图1是本申请第一实施例提供的消融导管的结构示意图；
图2是图1中的消融导管的局部结构示意图；
图3是图2所示的消融导管调弯后的结构示意图；
图4是图3所示的内鞘管的内部结构示意图；
图5是图4所示的牵引件的内部结构示意图；
图6是图1所示的手柄沿VI－VI线的剖视图；
[根据细则91更正 29.06.2021]图7是本申请第二实施例提供的消融导管的局部结构示意图。
具体实施方式
[根据细则91更正 29.06.2021]下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
[根据细则91更正 29.06.2021]此外，以下各实施例的说明是参考附加的图示，用以例示本申请可用以实施的特定实施例。本申请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图式的方向，因此，使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗指所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
方位定义：为了描述清晰，以下将手术过程中，靠近操作者的一端称为“近端”，将远离操作者的一端称为“远端”。该定义只是为了表述方便，并不能理解为对本申请的限制，“轴向”指的是承载杆的轴线方向或者手柄的轴心线方向。
[根据细则91更正 29.06.2021]请参阅图1，其为本申请第一实施例提供的消融导管100的结构示意图。本申请提供的消融导管100用于心脏消融，比如肺静脉、左心耳以及心室等组织消融。
消融导管100包括手柄10、内鞘管50和承载杆20，其中手柄10的远端与内鞘管50的近端固定连接，内鞘管50的远端与承载杆20的近端201固定连接，承载杆20的远端202还沿自身轴线203朝向背离手柄10的方向延伸。本实施方式中轴线203为承载杆20的中心轴线，并且与内鞘管50的中心轴线，以及手柄10的中心轴线重合。在其他变更实施方式中，不限定承载杆20的中心轴线，与内鞘管50的中心轴线，以及手柄10的中心轴线重合。
承载杆20包括近端段21，近端段21包括近端201，近端段21为杆状结构。承载杆20的远端202还间隔设置有标测环40和消融环30，且消融环30位于标测环40和手柄10之间。标测环40与消融环30整体均大致呈环形，标测环40和消融环30均围绕承载杆20的轴线203方向呈环状旋转延伸。可以理解的，在本申请消融导管100中，标测环40和消融环30的轴线相互重合，实际应用中，标测环40用于进入肺静脉中或左心耳中，并与管腔内壁一圈贴合，从而使得消融环30的轴线对准肺静脉的口部中心或者左心耳口部中心，便于消融环30环绕肺静脉口部或者左心耳口部进行消融。另外一种应用场景为，标测环40与消融环30用于在心室中对组织进行消融。下面以肺静脉消融为例进行说明，可以理解的是，消融导管100还用于对心脏中其他组织进行消融。在一种实施方式中，标测环40和消融环30的轴线相互平行。
标测环40上设置有标测电极41，标测环40通过标测电极41对目标组织区域中的电生理信号进行检测以达到标测功能，具体的，当标测环40贴合于肺静脉内壁的目标组织上时，消融导管100能够通过标测环40上的标测电极41进行肌电图(electromyography，EMG)心内信号检测。消融环30上设置有消融电极31，消融电极31用于向目标组织区域传递消融能量。且因为消融环30与标测环40间隔设置，在标测环40与目标组织区域贴合时，消融环30可利用消融电极31发射脉冲能源、射频能源或其他能源等，对目标组织区 域进行消融。
通过标测环40对目标组织区域的电生理信号进行检测，可以控制消融环30的消融能量，使其发出的消融能量对目标组织区域内的至少部分组织进行消融阻断，且因为不同组织在目标区域中产生的电生理信号不同，且不同组织对消融能量的反应阈值存在差异，因此消融环30可以针对目标组织区域中发出不期望产生的电生理信号的目标组织单独进行隔离，从而避免影响其余组织的正常工作。经消融后目标组织区域内产生的电生理信号符合期望，达到消除心房颤动的目的。本申请的消融导管100通过将标测环40和消融环30集成于一体，可以对目标组织进行标测的操作以及消融的操作，标测与消融的操作可以同时进行或分时进行。相较于现有技术中分别操控消融与标测两个设备进行消融和标测的场景，本申请的消融导管100简化了手术的操作步骤，使得手术过程更加便捷，也有利于提高手术的成功率。
在一种实施例中，环状的标测环40具有第一径向尺寸，环状的消融环30具有第二径向尺寸，且第二径向尺寸大于或等于第一径向尺寸。本实施方式中消融能源为脉冲，消融环30能够采用非接触式的方式对目标组织沿其径向进行消融，其基于消融能量所形成的消融作用区域沿消融环30的圆周呈环状向外发散。设置消融环30的第二径向尺寸大于或等于标测环40的第一径向尺寸，有利于消融环30在肺静脉外部环绕口部形成消融区域，从而适应肺静脉口部的解剖结构。
一种实施例，承载杆20沿自身轴线203的方向依次包括近端段21、消融环30和标测环40，且消融环30、标测环40以及近端段21为一体成型的结构。可以理解的，当消融环30、标测环40和近端段21为一体成型的结构时，承载杆20的远端202会绕轴线203旋转弯曲以先后形成消融环30和标测环40。承载杆20需要通过套设于承载杆20外部的外鞘管(图中未示)输送导引以抵达心脏位置，一体成型的承载杆20在输送过程中呈直线状收容于外鞘管中，其直径可收缩至较小的状态，以便于其在外鞘管中的输送，利于使用直径更小的外鞘管。当承载杆20在心脏中释放时，可自动膨胀至图1所示的形状，即形成间隔的消融环30和标测环40，以行使消融导管100的标测和消融操作。
请一并参阅图1与图2，在本申请消融导管100中，承载杆20还包括连接在消融环30与标测环40之间的连接段23，以实现消融环30与标测环40之间的间隔设置。连接段23包括第一区段231和第二区段232，其中第一区段231连接于第二区段232的近端，第二区段232连接于第一区段231与标测环40之间。第二区段232包括连接标测环40的一端232a以及连接第一区段231的一端232b，第二区段232连接第一区段231的一端232b相对于其连接标测环40的一端232a，距离标测环40的几何中心的距离更近。
在推动手柄10使得标测环40进入肺静脉的过程中，手柄10上的推力带动连接段23以及标测环40向肺静脉内移动，若标测环40抵顶到肺静脉口部组织上，第一区段231连接在更加靠近标测环40几何中心的第二区段232的一端232b，即第一区段231并非连接在标测环40的周向边缘，因此不会与肺静脉产生接触，有利于提高标测环40移动的灵活性，标测环40容易顺利进入肺静脉。可以理解的，若连接段23中第一区段231连接至标测环40的周向边缘，在标测环40抵顶到肺静脉口部组织的情况下，第一区段231继续推动标测环40时会容易直接将推力施加至组织区域，即施加压力将标测环40抵压在组织上， 标测环40滑入肺静脉的难度较大。
当标测环40边缘的一部分抵顶在肺静脉口部组织上，连接段23的第一区段231远端指向口部内时，标测环40都能较容易的进入肺静脉。进一步地，在图1的实施例中第一区段231沿轴线203的方向延伸，在第一区段231指向肺静脉口部边缘的情况下，标测环40都能较容易的进入肺静脉。
本实施方式中，第一区段231沿轴向延伸，轴向穿过消融环30以及标测环40的几何中心，在变更实施方式中，消融环30的几何中心以及标测环40的几何中心与轴线203不共线。在变更实施方式中，第一区段231平行于轴线203延伸，在其他实施方式中，第一区段231相对于轴向是倾斜的关系，比如夹角为锐角或者钝角。
第二区段232至少在径向上延伸。在变更实施方式中，第二区段232在轴向与径向上均有延伸，第二区段232上距离近端越近的位置，距离标测环40的几何中心越近。
另一方面，连接段23还包括第三区段233，第三区段233连接于消融环30和第一区段231之间。因为第一区段231沿轴线203延伸，轴线203穿过消融环30的几何中心，因此第三区段233连接在消融环30的几何中心与边缘之间。第三区段233的设置有利于保证第一区段231相对于标测环40以及消融环30的位置，使得消融环30与标测环40之间不易发生相对位移，从而提高承载件20在身体组织中的释放后移动的顺畅形以及定位的精准度。
本实施方式中，第三区段233在径向上延伸，并且其一端在消融环30的几何中心，在变更实施方式中，第三区段233在轴向以及径向上延伸，即第三区段233在轴向与径向上均延伸预定长度，第三区段233可以不经过消融环30的几何中心。
如图2所示，近端段21包括第四区段211和第五区段212，第四区段211连接于手柄10与第五区段212之间，更具体地，第四区段211连接于内鞘管50与第五区段212之间，第五区段212连接于第四区段211与消融环30之间。第五区段212连接第四区段211的一端212b相对于其连接消融环30的一端212a，距离消融环30的几何中心的距离更近。
在图1和图2的实施例中，第四区段211沿轴线203方向延伸。第四区段211与连接段23中的第一区段231同轴并沿轴线203延伸，有利于消融环30与标测环40均匀受力，消融环30与标测环40的顺利推进，另外也减小了两环在推进过程中的发生相对形变的几率。在变更实施方式中，第四区段211平行于轴线203设置，或者与轴线203形成的夹角为钝角或锐角。
本实施例中，消融环30与标测环40均呈开环结构，便于消融环30、标测环40、连接段23和近端段21一体成型。在输送状态下，承载杆20呈直线状收容于外鞘管内，承载杆20的一体成型，相对于承载杆由多区段组装而成，省略了设置于承载杆20上的多个区段之间的连接接头，有利于减小承载杆20的最大外径，方便使用更小直径的外鞘管，方便承载件20的装载、输送与回撤，并提高了承载杆20的安全性与可靠性。在变更实施方式中，不限定消融环30、标测环40和近端段21一体成型，也不限定消融环30、标测环40、连接段23和近端段21一体成型。
在一种实施方式中，近端段21与消融环30之间的连接处，以及连接段23分别与消融环30和标测环40之间的连接处均设有圆弧过渡。圆弧过渡的连接结构可以减小一体成型 的承载杆20在拐弯位置的应力集中现象，避免承载杆20在弯折并形成消融环30和标测环40的过程中出现裂纹或折断，另外，也降低了承载杆20刮伤刺伤组织的风险。相应的，在连接段23的内部，即第一区段231分别与第二区段232和第三区段233之间，以及在近端段21内的第四区段211和第五区段212之间，也可以设置圆弧过渡。
请参见图2，图2为本申请消融导管100中标测环40和消融环30的局部示意图。在图2的示意中，环形的消融环30形成于第一平面101内，方便在肺静脉口部形成环形的消融区域；环形的标测环40形成于第二平面102内，便于标测环40进入肺静脉中并与肺静脉内壁抵接，从而将消融环30定位于肺静脉口部对准肺静脉中心，第一平面101垂直于承载杆20的轴线203设置，并且第二平面102垂直于承载杆20的轴线203设置。变更实施方式中，第一平面101或第二平面102垂直于承载杆20的轴线203设置，另一变更实施方式中，第一平面101与第二平面102不平行，及/或第一平面101或第二平面102不垂直于轴线203。
本实施方式中，第一平面101平行于第二平面102设置，以达到消融环30上任意位置与标测环40上对应位置的距离相等，即垂直于第一平面101和第二平面102设置的任意平面分别与消融环30和标测环40相交的位置之间的距离相等，便于根据标测环40的检测结果控制消融环30输出的消融能量。而将第一平面101和第二平面102均设置为垂直于承载杆20的轴线203，便于手术过程中利用手柄10对标测环40和消融环30的定位。
在其他实施方式中，不限定环形的消融环30形成于第一平面101内，环形的标测环40形成于第二平面102内，第一平面101垂直于承载杆20的轴线203设置，以及第二平面102垂直于承载杆20的轴线203设置。
请进一步参见图2，标测环40上的标测电极41数量为多个，多个标测电极41沿标测环40的周向间隔设置。优选地，多个标测电极41沿标测环40的圆周均匀间隔分布排列。多个标测电极41可以从多个方向对目标组织区域进行电生理信号的采集，有利于快速准确的对病灶实现定位。
消融电极31的数量也为多个，多个消融电极31在消融环30上也沿其周向间隔设置。优选地，多个消融电极31沿消融环30的圆周均匀间隔分布排列。多个消融电极31可以从多个方向发出消融能量，并使得消融环30发出的消融能量形成环状，有效的作用于目标组织区域的从而对病灶进行隔离。
本实施例中，本申请消融导管100采用脉冲能源进行消融。脉冲能源的消融是利用高强度的脉冲电场使细胞膜发生不可逆的电击穿，在医学领域称之为不可逆电穿孔(irreversible electroporation，IRE)，使得细胞凋亡从而实现非热效应消融细胞，且不受热沉效应影响。高电压脉冲序列产热少，不需要生理盐水冲洗冷却，可有效减少气爆、焦痂和血栓的发生。且脉冲消融的治疗时间较短，通常施加一组脉冲序列的治疗时间不到1分钟，全程消融时间通常不超过5分钟。由于不同目标组织对脉冲电场的反应阈值存在差异，消融心肌时可以不干扰到其他临近组织，避免误伤肺静脉临近的食道和膈神经组织。
另一方面，脉冲消融不需要热传导来对深层组织进行消融，所有分布在消融环30发出的脉冲电场强度范围内的心肌细胞均会发生电穿孔，降低了消融时对消融导管100与目标组织贴靠的压力要求。即本申请消融导管100在进入心房内后，不需要将消融环30完全地 贴合目标组织内壁。而在消融完成后，还可以通过标测环40及时监测心内电生理信号，判断目标组织是否已经完全电隔离。
对于采用脉冲能源的消融导管100，其分布于消融环30上的多个消融电极31还需要设置其正负电极交替排列，以保证脉冲能源经多个消融电极31产生闭环的损伤区域。
请参阅图3与图4，内鞘管50为中空管状，其远端202设置有弯曲段51，弯曲段51可调弯。弯曲段51为弹性材料制备，弯曲段51的硬度小于内鞘管50中其他区段的硬度，以方便调弯。弯曲段51的设置可以精确控制到内鞘管50在弯曲时发生变形的具体部位，避免造成标测环40与消融环30发生相对变形，进而影响到消融导管100的消融效果。
内鞘管50的管壁中沿轴线203的方向设有至少一根牵引件52。牵引件52的两端分别连接于弯曲段51的远端以及手柄10。其中牵引件52与弯曲段51的远端为固定连接，手柄10上设有与牵引件52连接并可牵拉牵引件52的调整旋钮11，通过旋转调整旋钮11相对于手柄10的角度，可以拉紧至少一牵引件52，进而使得弯曲段51向一个方向弯曲(如图5所示)，通过控制调整旋钮11旋转的角度改变弯曲段51发生对应的弯曲角度。弯曲后的内鞘管50可以调整标测环40和消融环30的朝向，以便于标测环40转向进入目标管腔中，消融环30贴近目标组织区域进行标测和消融。
请参阅图5，牵引件52包括牵引管521以及牵引丝522。牵引管521呈中空管状，其内部空腔用于穿置牵引丝522，牵引丝522的两端用于连接弯曲段51的远端以及手柄10。牵引丝522可以为不锈钢丝，在一种实施方式中，牵引丝522为覆有涂层的不锈钢丝，其表面平滑，具有良好的操控性。牵引管521可以是弹簧圈，弹簧圈包裹着不锈钢丝，可以保持内鞘管50平滑调弯。
在一种实施方式中，牵引件52省略设置牵引管521，即牵引件52为牵引丝。
本实施方式中，内鞘管50的管壁中相对设置有两根牵引件52，通过调整旋钮11(图1)的旋转牵引两根牵引件52，来控制弯曲段51的向两个相反的方向弯曲，这样的设置使得消融导管100的远端能够灵活地朝向2个方向转向，提高了消融导管100的可操作性与使用便捷性。可以理解的，牵引件52的数量可以多于两根，使得内鞘管50的弯曲段51能够朝向多个方向弯曲。
请参阅图6，手柄10包括壳体111，以及设置于壳体111内的调节件152、用于驱动调节件152沿内鞘管50的轴向移动的驱动件154，两根牵引丝522沿内鞘管50的轴向可滑动地置于内鞘管50的管壁内，壳体111内设绕线部1115，优选的，绕线部1115邻近调节件152的近端处。两根牵引丝522的远端连接于弯曲段51(图3)远端，其中一牵引丝522的近端连接于调节件152，另一牵引丝522的近端绕过绕线部1115连接于调节件152。具体的，其中一根牵引丝522的远端固定于弯曲段51的远端，其中一牵引丝522的近端直接连接于调节件152；另一牵引丝522的远端固定于弯曲段51的远端，另一牵引丝522的近端绕过绕线部1115后连接于调节件152。
驱动件154的外壁周向固定有调整旋钮11，调整旋钮11的转动带动驱动件154的转动。驱动件154的转动通过其内螺纹驱动调节件152移动并带动两根牵引丝522滑动，使鞘管23的弯曲段51往不同方向弯曲，即弯曲段51可往不同方向弯曲且弹性复位。
对内鞘管50进行调弯时，通过操作调整旋钮11使驱动件154转动，以带动调节件152 向近端或远端转动且轴向移动。在初始状态下，当调节件152向近端转动且轴向移动时，带动直接固定在调节件152的牵引丝522朝近端滑动，以使弯曲段51朝向受拉牵引丝522的一侧弯曲，弯曲段51在弯曲的过程中，绕过绕线部1115后连接于调节件252的牵引丝522被弯曲段51的变形而拉向远端滑动，以使弯曲段51完成弯曲；在初始状态下，当调节件152向远端转动且轴向移动时，绕过绕线部1115后连接于调节件152的牵引丝522被调节件152带动朝近端滑动，使弯曲段51朝向受拉牵引丝256的一侧弯曲，弯曲段51在弯曲的过程中会带动直接固定在调节件152的牵引丝522朝远端滑动，以使弯曲段51完成弯曲。
需要说明的是，初始状态是指内鞘管50的弯曲段51处在伸直状态。
请再次参见图4与图1，本申请消融导管100还包括连接于手柄10上的连接件60。本实施方式中，连接件60连接于手柄10的近端位置，且连接件60包括有检测接口61和供能接口62。其中检测接口61与标测环40上的标测电极41电性连接，用于接收标测环40检测到的电生理信号。供能接口62与消融环30上的消融电极31电性连接，用于将外部能量传递给消融环30进行消融。供能接口62用于连接外部的脉冲能源、射频能源或微波能源。
内鞘管50呈中空管状，其内布置有多个导线24，导线24之间相互绝缘。检测接口61通过导线24与标测环40上分布的多个标测电极41导通，每个标测电极41所检测到的电生理信号通过一导线24传递至检测接口61，再由检测接口61将电生理信号传递给外部检测仪器；供能接口62通过区别于检测接口61处的导线24与消融环30上分布的多个消融电极31导通，供能接口62接收外部能量并将其传递给各个消融电极31，使得消融电极31基于外部能量形成消融能量，并作用于目标组织区域。
请参见图7，本申请第二实施例中提供的消融环70与第一实施例中的消融环40的主要区别在于，消融环70包括有两个子消融环，分别为第一消融环701和第二消融环702，第一消融环701设置于第二消融环702和标测环40之间。
第一消融环701和第二消融环702上还分别间隔设置有消融电极71，第一消融环701和第二消融环702分别具备发射消融能量的功能。
可以理解的，当第一消融环701单独工作时，其形成的消融能量的作用范围与第二消融环702单独工作时形成的消融能量的作用范围相异，因此本申请的消融导管100能够通过设置两个间隔的子消融环以覆盖更大区域的消融范围。而且，基于标测环40检测到的目标组织区域中异常电生理信号的不同来源位置，本申请的消融导管100能够控制不同的子消融环来发射消融能量，来作用于不同的目标组织区域进行电隔离；或控制两个子消融环同时发射消融能量，来提供更大的消融能量以缩短手术时间。可以理解的，在其他实施例中，消融导管100的子消融环数量还可以为两个以上，以进一步扩大消融环70的作用范围。在一种实施方式中，第一消融环701中的部分电极71与第二消融环702中的部分电极同时开启，以对指定区域进行消融。
在图7所示的实施例中，第二消融环702的径向尺寸大于第一消融环701的径向尺寸。两个子消融环的径向尺寸差异设置可形成不同的消融能量作用范围。同时越靠近测标环40一侧的子消融环的径向尺寸越小，则使得本申请消融导管100在远端位置形成的圆环结构 的径向尺寸逐渐减小，可以根据目标脉管组织不同的直径选择第一消融环701或者第二消融环702开启进行消融，比如当患者的肺静脉较窄时，选择开启第一消融环701上的消融电极71，关闭第二消融环702上的消融电极71，利用第一消融环701贴近肺静脉口部进行消融；当患者的肺静脉较宽时，第一消融环701能够进入至肺静脉内部，选择开启第二消融环702上的消融电极71，关闭第一消融环701上的消融电极71，利用第二消融环702贴近肺静脉口部进行消融，以目标组织实现更好的贴合以及消融作用。
具体的，承载杆在第一消融环701和第二消融环702之间设置有第六区段234，第六区段234可以沿平行或重合于轴线的方向设置，或者与轴线呈锐角或钝角倾斜设置，第六区段234两端还可设置用于连接第一消融环701和第二消融环702的其他连接区段，以使得第六区段234利于推动第一消融环701和标测环40在静脉血管中的移动。
[根据细则91更正 29.06.2021]以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (10)

  1. 一种消融导管，其特征在于，包括手柄以及连接于所述手柄远端的承载杆，所述承载杆包括设置于其远端的标测环和消融环，所述消融环位于所述标测环和所述手柄之间，所述标测环与所述消融环均呈环形，并围绕所述承载杆的轴线延伸，所述标测环上设置有标测电极，所述消融环上设置有消融电极，所述消融电极用于向目标组织区域传递消融能量，所述标测电极用于将目标组织区域中的电生理信号传输至所述手柄。
  2. 如权利要求1所述的消融导管，其特征在于，所述消融环的径向尺寸大于或等于所述标测环的径向尺寸。
  3. 如权利要求1所述的消融导管，其特征在于，所述承载杆包括连接于所述手柄与所述消融环之间的近端段，所述消融环、所述标测环和所述近端段为一体成型结构。
  4. 如权利要求3所述的消融导管，其特征在于，所述承载杆还包括连接在所述消融环与所述标测环之间的连接段，所述连接段包括第一区段和第二区段，所述第二区段连接于所述第一区段与所述标测环之间，所述第二区段连接所述第一区段的一端相对于其连接所述标测环的一端，距离所述标测环的几何中心的距离更近；及/或
    所述近端段包括第四区段和第五区段，所述第五区段连接于所述第四区段与所述消融环之间，所述第五区段连接所述第四区段的一端相对于其连接所述标测环的一端，距离所述消融环几何中心的距离更近。
  5. 如权利要求1所述的消融导管，其特征在于，所述消融环形成于第一平面内，所述标测环形成于第二平面内。
  6. 如权利要求5所述的消融导管，其特征在于，所述第一平面及/或所述第二平面垂直于所述承载杆的轴线。
  7. 如权利要求1－6任一项所述的消融导管，其特征在于，所述标测电极数量为多个，多个标测电极沿所述标测环的周向上间隔设置；及/或，所述消融电极的数量为多个，多个消融电极中的正负电极交替排列。
  8. 如权利要求1－6任一项所述的消融导管，其特征在于，所述消融环包括第一消融环和第二消融环，且所述第二消融环相对于所述手柄设置于所述第一消融环的近端，所述第一消融环和所述第二消融环上均设置有消融电极。
  9. 如权利要求8所述的消融导管，其特征在于，所述第二消融环的径向尺寸大于所述第一消融环的径向尺寸。
  10. 如权利要求1－6任一项所述的消融导管，其特征在于，所述消融导管在所述承载杆与所述手柄之间设置有内鞘管，所述内鞘管的管壁内沿轴向设有牵引件，所述牵引件连接在所述内鞘管的远端和所述手柄之间，所述手柄通过牵拉所述牵引件以使得所述内鞘管的远端向一个方向弯曲。
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