CN109953812B - Mapping, freezing and ablation integrated catheter - Google Patents

Mapping, freezing and ablation integrated catheter Download PDF

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Publication number
CN109953812B
CN109953812B CN201711421997.8A CN201711421997A CN109953812B CN 109953812 B CN109953812 B CN 109953812B CN 201711421997 A CN201711421997 A CN 201711421997A CN 109953812 B CN109953812 B CN 109953812B
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balloon
strip
electrode
array
cryoablation
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CN109953812A (en
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李楚武
朱晓林
邹波
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Sichuan Jinjiang Electronic Medical Device Technology Co ltd
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Sichuan Jinjiang Electronic Science and Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
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    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
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    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00642Sensing and controlling the application of energy with feedback, i.e. closed loop control
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    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00714Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
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    • A61B2018/00994Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/1206Generators therefor
    • A61B2018/1273Generators therefor including multiple generators in one device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe

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Abstract

The invention relates to the field of cryoablation, in particular to a mapping cryoablation integrated catheter, which comprises: a tube having a front end section with a free end; a balloon which is arranged on the free end of the front end section and can be filled with a freezing medium to realize expansion or contraction; the front end section of the control handle is arranged on the control handle and can be controlled to bend by the control handle; the invention aims to provide a mapping and cryoablation integrated catheter which is more efficient in modeling, can better detect the matching state of the balloon and pulmonary vein ostium target tissues in the process of cryoablation of pulmonary veins, finally has a better ablation effect, and can detect the ablation effect more accurately.

Description

Mapping, freezing and ablation integrated catheter
Technical Field
The invention relates to the field of cryoablation, in particular to a mapping cryoablation integrated catheter.
Background
Radiofrequency ablation catheters or cryoablation catheters are currently used clinically for the treatment of cardiac arrhythmias in the atria, such as atrial premature contraction, atrial flutter, bypass tachycardia, atrial fibrillation, and AV nodal reentrant tachycardia, ventricular arrhythmias in the ventricles, such as ventricular premature contraction, ventricular tachycardia, ventricular fibrillation, and long-term QT syndrome.
For most arrhythmia treatments, rf ablation is safe and effective, but limitations and disadvantages remain. Radiofrequency energy can disrupt the structure and integrity of endothelium and tissue, easily leading to thrombosis and embolism. Excessive heat in the radio frequency can cause increased impedance and can cause barotrauma and myocardial perforation.
In order to achieve a deeper ablation depth, higher ablation energy is clinically used, which often causes local overheating of myocardial tissue to cause scabbing, thereby affecting the effectiveness and safety of the operation.
Meanwhile, the application of radio frequency ablation to atrial fibrillation treatment also faces many clinical problems: such as the danger of heart perforation, the inconsistency of the temperature of the surface layer and the inner part of the cardiac muscle, the damage of the phrenic nerve, the formation of ablation carbonization/concretion, the long learning curve of atrial fibrillation ablation operation, the high operation difficulty and technical requirements, the difficulty of obtaining consistent results of different operators and the great difference of success rate. The point-by-point ablation method is very time-consuming, and the operation time of many operators is more than 3 hours.
Cryoablation therapy is an interventional technique that has been applied in recent years to the treatment of cardiac arrhythmias. The cryoablation catheter has the characteristics of cryoadhesion, cryomapping and cryoablation, and in addition, the tissue damage caused by freezing has complete envelope, clear boundary and extremely low occurrence rate of thrombus, and the cryoablation is a reversible process at a certain temperature, so that the occurrence of complications such as III-degree atrioventricular conduction block and the like can be reduced. In terms of energy, radiofrequency ablation delivers thermal energy to the tissue, while cryoablation absorbs thermal energy from the tissue. Thus, it was determined that cryoablation has unique advantages. Theoretically, cryoablation is superior to rf ablation in its operability and safety. Literature statistics show that the cryoablation effect is not inferior to the radiofrequency ablation effect.
The refrigerant commonly used for cryoablation is N2、(N2O) and dry ice (CO)2) Refrigerant (namely freezing medium) enters the balloon at the front end of the device, expands the balloon to enable the balloon to be attached to target tissue (the balloon is provided with a central axis and an equator, namely, a plane where the equator is located is perpendicular to the central axis and is located in the middle of the balloon), reduces the temperature of the target tissue to be below 0 ℃, enables interstitial fluid inside and outside cells to form ice crystals, and destroys cell structures. Thereby dehydrating the cells and denaturing the lipoproteins in the membrane system to necrosis. The short-time freezing at-10 deg.C to-25 deg.C can only make the extracellular ice crystal form, but can not completely destroy the tissue cells, but the freezing time can be increasedThe tissue cells are completely destroyed, ice crystals can be formed inside and outside the cells in a short time at-40 ℃ and below, so that the cells are necrotized, and specific parameters (temperature and time) are selected according to the requirements of clinical symptoms.
There are several drawbacks to cryoablation when it is aimed at cryoablation of the pulmonary vein ostium.
When the balloon is expanded after reaching the pulmonary vein opening (the balloon is filled with refrigerant or normal temperature gas), the attaching degree of the balloon cannot be known, and the cryoablation effect can be influenced if the position of the balloon is not right, the balloon is too large, the pressure of the tissue is too large or the balloon is not sufficiently expanded and the tissue is not tightly matched;
meanwhile, after ablation is finished, the ablation effect of the tissue cannot be measured well, the current cryoablation effect measurement is to arrange a spiral electrode at the front end of a balloon, then the electrode is contacted with pulmonary vein tissue at the front end of the balloon to send stimulation signals, the rear end of the balloon is provided with an electrode for receiving the signals, if the stimulation signals can be received, ablation is successful, but the mode is not accurate, the specific ablation condition of a target tissue area corresponding to the circumference of the balloon cannot be known clearly, if only a narrow circle of ablation is successful because the early-stage attaching condition is not ideal or the factors such as the later-stage temperature and the like are not well controlled, the rear end of the balloon cannot receive the stimulation signals, the judgment is successful, but the ablation effect is not good in practice, and most of disease target tissues are not processed by cryoablation;
secondly, when the saccule reaches the left atrium or the pulmonary vein ostium, the front end of the saccule extends out of the spiral mapping assembly for modeling, and the current modeling speed is low and the modeling efficiency is low.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide the integrated mapping and cryoablation catheter which has higher modeling efficiency, can better detect the matching state of the balloon and the target point tissue of the pulmonary vein opening in the process of cryoablation of the pulmonary vein, finally has better ablation effect and can detect the ablation effect more accurately.
In order to achieve the purpose, the invention adopts the technical scheme that:
a mapping cryoablation integrated catheter, comprising:
a tubular body having a front end section with a free end;
a balloon disposed on the free end of the leading end segment and capable of being filled with a freezing medium to effect expansion or contraction;
the pipe body is arranged on the control handle and can be controlled to bend by the control handle;
the balloon is characterized in that a strip-shaped carrier is arranged on the outer surface of the upper edge of the balloon, one end of the strip-shaped carrier is connected with the free end, the other end of the strip-shaped carrier is connected with one end, opposite to the free end, of the balloon, array electrodes are distributed on the strip-shaped carrier, and all the array electrodes are in a spherical array along the outer surface of the balloon.
The balloon is provided with the strip-shaped carrier along the outer surface (the structure is more optimized, the array electrodes are easier to group, meanwhile, related electrode wires are convenient to arrange, the electrode wires of the array electrodes are connected to the front end section from the inside of the balloon or the strip-shaped carrier and are finally connected to the ablation instrument at the rear end), then the strip-shaped carrier is provided with the array electrodes, all the array electrodes are in a spherical array along the outer surface of the balloon, the distribution is more uniform, when the balloon enters a left ventricle, the array electrodes can be matched with the ablation instrument at the rear end to perform rapid modeling, the modeling efficiency is higher, meanwhile, the array electrodes are more accurate, the arrangement of the array electrodes is that the array electrodes are arranged from one end of the balloon to the other end (here, the arrangement can be explained as the head end and the tail end of the balloon, the tail end of the balloon is connected with the free end of the front end section), and the, matching and adjusting during modeling with a heart, so that the balloon can be conveniently and accurately moved to a target tissue of a pulmonary vein opening, the balloon is contacted with the target tissue of the pulmonary vein opening when being expanded to a certain degree, impedance detection is carried out by discharging between different array electrodes on the balloon, the impedance of the attached tissue is detected, and a proper attaching degree is calculated (the closer the balloon is, the smaller the impedance is, otherwise, the larger the impedance is, the pressure problem in the background technology is solved, the attaching effect is judged by using the impedance instead of a mode of judging through pressure), therefore, the effect of blocking the pulmonary vein opening by the balloon is fed back through the size of the balloon and the attaching degree in real time, when the blocking is good, cryoablation is started, and the ablation effect is better;
meanwhile, after the ablation is completed, the array electrode can emit stimulation, and then whether a stimulation signal can be detected or not is detected on the outer side of the pulmonary vein (in the direction of the head end/tail end of the balloon or more), if the stimulation signal cannot be detected, the ablation is successful, otherwise, the ablation fails, because the array electrode extends from the head end to the tail end of the balloon in an array mode, the array electrode can contact more tissues on the axis of the pulmonary vein, namely, even if the 'only a narrow circle is ablated successfully' as in the background technology, the array electrode can contact two sides of the circle of tissues besides the part of tissues ablated successfully, so that the stimulation signal emitted by the part of the array electrode on the outer side can be received, the ablation is not successful, and the unsuccessful state of 'only a narrow circle is ablated successfully' in the background technology is successfully identified, the detection is more accurate.
Meanwhile, one electrode of the adjacent array can send stimulation signals and the other electrode can receive the stimulation signals, and the principle is that if the stimulation signals can be received, the ablation is proved to be unsuccessful, but the ablation success range can be more accurately detected in a transverse mode (the transverse mode is in the direction along the equator direction of the balloon), and the detection is more accurate in cooperation with the detection mode.
Meanwhile, the traditional spiral mapping assembly is omitted, so that the structure is optimized, the operation is simpler during use, the front end section can be made thinner, and the intervention in the body of a patient is facilitated.
As a preferable aspect of the present invention, the number of the strip carriers is three or more, and the adjacent strip carriers are distributed with a fixed angle therebetween centering on the central axis of the balloon.
As a preferable scheme of the present invention, the number of the strip carriers is odd, and the adjacent strip carriers are distributed with a fixed angle therebetween and with the central axis of the balloon as the center.
As a preferable aspect of the present invention, the number of the strip carriers is even, and the adjacent strip carriers are distributed with a fixed angle therebetween centering on the central axis of the balloon.
In a preferred embodiment of the present invention, the number of the strip carriers is eight, and the adjacent strip carriers are distributed at an angle of 45 ° with the central axis of the balloon as the center.
As a preferred scheme of the present invention, the outer surface of the free end of the front end section is provided with an annular proximal electrode, the proximal electrode can be matched with the array electrode, the size of the balloon can be better determined in the process of measuring the potential difference, the balloon can be conveniently and accurately moved to the target tissue of the pulmonary vein ostium, and simultaneously the impedance can be detected by matching with the array electrode, so that the sticking degree of the balloon and the tissue can be more comprehensively determined, of course, the effect detection after ablation can also be used as a device for detecting a stimulation signal, and the determination of the ablation effect is facilitated while the structure is more optimal.
As a preferred aspect of the present invention, an end of the balloon connected to the free end of the leading end section is a balloon tail end, an end opposite to the balloon tail end is a balloon head end, the balloon head end is provided with a protrusion extending outward, an annular distal electrode is provided on an outer surface of the protrusion, and in effect detection after ablation, the balloon is used as a device for detecting a stimulation signal, and the device can be used to determine the impedance condition of the leading half portion of the balloon contacting the tissue in cooperation with an array electrode (particularly, the array electrode located in the leading half portion of the balloon), so as to facilitate determination of the ablation effect.
As a preferable scheme of the invention, the top end of the bulge is provided with an arc-shaped injury prevention structure, so that the pulmonary vein orifice and the inner wall of the left atrium are better protected.
The invention has the beneficial effects that:
the balloon is provided with the strip-shaped carrier along the outer surface (the structure is more optimized, the array electrodes are easier to group, meanwhile, related electrode wires are convenient to arrange, the electrode wires of the array electrodes are connected to the front end section from the inside of the balloon or the strip-shaped carrier and are finally connected to the ablation instrument at the rear end), then the strip-shaped carrier is provided with the array electrodes, all the array electrodes are in a spherical array along the outer surface of the balloon, the distribution is more uniform, when the balloon enters a left ventricle, the array electrodes can be matched with the ablation instrument at the rear end to perform rapid modeling, the modeling efficiency is higher, meanwhile, the array electrodes are more accurate, the arrangement of the array electrodes is that the array electrodes are arranged from one end of the balloon to the other end (here, the arrangement can be explained as the head end and the tail end of the balloon, the tail end of the balloon is connected with the free end of the front end section), and the, matching and adjusting during modeling with a heart, so that the balloon can be conveniently and accurately moved to a target tissue of a pulmonary vein opening, the balloon is contacted with the target tissue of the pulmonary vein opening when being expanded to a certain degree, impedance detection is carried out by discharging between different array electrodes on the balloon, the impedance of the attached tissue is detected, and a proper attaching degree is calculated (the closer the balloon is, the smaller the impedance is, otherwise, the larger the impedance is, the pressure problem in the background technology is solved, the attaching effect is judged by using the impedance instead of a mode of judging through pressure), therefore, the effect of blocking the pulmonary vein opening by the balloon is fed back through the size of the balloon and the attaching degree in real time, when the blocking is good, cryoablation is started, and the ablation effect is better;
meanwhile, after the ablation is completed, the array electrode can emit stimulation, and then whether a stimulation signal can be detected or not is detected on the outer side of the pulmonary vein (in the direction of the head end/tail end of the balloon or more), if the stimulation signal cannot be detected, the ablation is successful, otherwise, the ablation fails, because the array electrode extends from the head end to the tail end of the balloon in an array mode, the array electrode can contact more tissues on the axis of the pulmonary vein, namely, even if the 'only a narrow circle is ablated successfully' as in the background technology, the array electrode can contact two sides of the circle of tissues besides the part of tissues ablated successfully, so that the stimulation signal emitted by the part of the array electrode on the outer side can be received, the ablation is not successful, and the unsuccessful state of 'only a narrow circle is ablated successfully' in the background technology is successfully identified, the detection is more accurate.
Meanwhile, one electrode of the adjacent array can send stimulation signals and the other electrode can receive the stimulation signals, and the principle is that if the stimulation signals can be received, the ablation is proved to be unsuccessful, but the ablation success range can be more accurately detected in a transverse mode (the transverse mode is in the direction along the equator direction of the balloon), and the detection is more accurate in cooperation with the detection mode.
Meanwhile, the traditional spiral mapping assembly is omitted, so that the structure is optimized, the operation is simpler during use, the front end section can be made thinner, and the intervention in the body of a patient is facilitated.
Drawings
Fig. 1 is a first view structural diagram of embodiment 1 of the present invention;
FIG. 2 is a schematic structural diagram of a second perspective view according to embodiment 1 of the present invention;
FIG. 3 is a schematic view of the balloon of example 1 of the present invention just prior to insertion into the left atrium;
FIG. 4 is a schematic representation of the balloon of example 1 of the present invention as it was inflated to target after it was inserted into the left atrium;
FIG. 5 is a schematic view showing the balloon and the ostium apposition of the pulmonary veins of example 1 of the present invention;
FIG. 6 is a schematic structural view of a balloon of example 1 of the present invention in an inflated state;
FIG. 7 is a schematic structural view of a balloon in a deflated state according to example 1 of the present invention;
the labels in the figure are: 1-balloon, 2-array electrode A, 3-array electrode B, 4-array electrode C, 5-array electrode D, 6-array electrode E, 71-distal electrode A, 72-distal electrode B, 81-proximal electrode A, 82-proximal electrode B, 61-strip carrier, 9-air inlet pipe, 10-air outlet pipe, 11-magnetic positioning sensor, 12-damage prevention structure, 22-sheath pipe, 13-control handle, 14-tube body, 15-pressure and flow sensor, 16-electrode connector and 17-freezing connecting device.
Detailed Description
The present invention will be described in further detail with reference to examples and embodiments. It should be understood that the scope of the above subject matter of the present invention is not limited to the following examples, and any technique realized based on the summary of the present invention is within the scope of the present invention.
Example 1
As shown in fig. 1, 2, 6 and 7, a mapping cryoablation integrated catheter includes:
a tube 14 having a front end section with a free end;
a balloon 1, the balloon 1 being arranged on the free end of the front end section and being capable of being filled with a freezing medium for expansion or contraction;
a control handle 13, wherein the tube 14 is mounted on the control handle 13 and can be controlled to bend by the control handle 13.
The balloon body 1 is provided with a strip-shaped carrier 61 along the outer surface, one end of the strip-shaped carrier 61 is connected with the free end, the other end of the strip-shaped carrier 61 is connected with one end, opposite to the free end, of the balloon body 1, array electrodes are distributed on the strip-shaped carrier 61, and all the array electrodes are in a spherical array along the outer surface of the balloon body 1.
In this embodiment, the number of the strip carriers 61 is more than three, and the adjacent strip carriers 61 are distributed with a fixed angle between each other and the central axis of the balloon 1 as the center, specifically, the number of the strip carriers 61 is even, as can be seen from fig. 1-2, in the embodiment, the number of the strip carriers 61 is eight, the adjacent strip carriers 61 are distributed with a 45 ° angle between each other and the central axis of the balloon 1 as the center, and 5 array electrodes are distributed on a single strip carrier 61, as shown in fig. 1, the array electrode a2, the array electrode B3, the array electrode C4, the array electrode D5, and the array electrode E6.
The balloon 1 is provided with a balloon 1 tail end at one end connected with the free end of the front end section, a balloon 1 head end at the end opposite to the balloon 1 tail end, the balloon 1 head end is provided with a bulge extending outwards, the outer surface of the bulge is provided with an annular far-end electrode, and the far-end electrode in the embodiment is arranged on the outer surface of the bulgeThe balloon is provided with two electrodes, namely a far-end electrode A71 and a far-end electrode B72, the top end of the protrusion is provided with an arc-shaped anti-damage structure 12, the outer surface of the free end of the front end section is provided with an annular near-end electrode, in the embodiment, the two electrodes are a near-end electrode A81 and a near-end electrode B82, the free end in the front end section is provided with an air inlet pipeline 9 and an air outlet pipeline 10 which extend into the balloon 1 and are used for conveying a freezing medium with the temperature reaching the standard into the balloon 1 for refrigeration, and meanwhile, the freezing medium with the increased temperature and needing to be cooled again is output, and is made of pressurized gas, such as N2、(N2O) and dry ice (CO)2) And the like.
A magnetic positioning sensor 11 is further arranged beside the proximal electrode and used for helping to judge the position of the balloon 1, an electrode connector 16 and a freezing connecting device 17 are arranged in the control handle 13, the electrode connector 16 penetrates through the control handle 13 through a lead and is finally connected with the array electrode, the distal electrode and the proximal electrode, the array electrode, the distal electrode and the proximal electrode are connected with an ablation instrument at the rear end through the electrode connector 16, the ablation instrument is respectively transmitted with the array electrode, the distal electrode and the proximal electrode for electric energy and signals, the array electrode, the distal electrode and the proximal electrode are controlled to carry out different working states, the inner space of the balloon 1 is connected with the ablation instrument through the freezing connecting device 17, the ablation instrument delivers a cooling medium into the balloon 1 through the freezing connecting device 17 and controls the ablation process through controlling parameters such as flow and temperature, a pressure and flow sensor 15 is provided in the cryo-link 17 to monitor whether the pressure of the cooling medium delivered by the ablator is within a safe range.
The ablation process is as shown in fig. 3-5, as shown in fig. 3, the catheter body enters the left atrium under the guidance of the sheath 22, then as shown in fig. 4, the balloon 1 is inflated (the balloon 1 is inflated by not necessarily a freezing medium but also normal temperature gas in this step), the array electrodes are made to be in a spherical array, then the balloon is matched with an ablation instrument to perform rapid modeling, then the inflation degree and position of the balloon 1 are judged under the matching of the array electrodes, the distal electrode, the proximal electrode and the magnetic positioning sensor 11, then the model is compared with the established model to find the proper contact position with the pulmonary vein ostium, as shown in fig. 5, then according to the matching of the array electrodes, the distal electrode and the proximal electrode, the contact degree of the balloon 1 and the pulmonary vein ostium tissue is judged by the above impedance measurement mode, then adjustment is performed, after the optimal state is found, the cooling medium is delivered into the balloon 1, cryoablation is performed.
Example 2
In this embodiment, the difference from embodiment 1 is that the number of the strip carriers 61 is odd, and the adjacent strip carriers 61 are distributed with the central axis of the balloon 1 as the center at a fixed angle.

Claims (6)

1. A mapping cryoablation integrated catheter, comprising:
a tubular body having a front end section with a free end; a balloon disposed on the free end of the leading end segment and capable of being filled with a freezing medium to effect expansion or contraction;
the bending control device is characterized by further comprising a control handle, wherein the pipe body is installed on the control handle and can be controlled to bend by the control handle;
a strip-shaped carrier is arranged on the outer surface of the upper edge of the balloon, one end of the strip-shaped carrier is connected with the free end, the other end of the strip-shaped carrier is connected with one end, opposite to the free end, of the balloon, array electrodes are distributed on the strip-shaped carrier, and all the array electrodes are in a spherical array along the outer surface of the balloon;
the outer surface of the free end of the front end section is provided with an annular near-end electrode, one end of the balloon connected with the free end of the front end section is a balloon tail end, the end opposite to the balloon tail end is a balloon head end, the balloon head end is provided with a bulge which is outwards extended, and the outer surface of the bulge is provided with an annular far-end electrode;
the near-end electrode and the array electrode are matched with each other, and the real-time size of the balloon is judged according to the potential difference between different array electrodes;
the far-end electrode is used as a device for detecting a stimulation signal in effect detection after ablation, and is matched with the array electrode to judge the impedance of the front half part of the balloon contacting with tissues.
2. The integrated catheter for mapping, freezing and ablating according to claim 1, wherein the number of the strip-shaped carriers is more than three, and the adjacent strip-shaped carriers are distributed with a fixed angle therebetween and centered on the central axis of the balloon.
3. The integrated mapping and cryoablation catheter as claimed in claim 2, wherein the number of the strip-shaped carriers is odd, and the adjacent strip-shaped carriers are distributed at a fixed angle around the central axis of the balloon.
4. The integrated mapping and cryoablation catheter as claimed in claim 2, wherein the number of the strip-shaped carriers is even, and the adjacent strip-shaped carriers are distributed at a fixed angle around the central axis of the balloon.
5. The integrated mapping and cryoablation catheter as claimed in claim 2, wherein the number of the strip-shaped carriers is eight, and the adjacent strip-shaped carriers are distributed at an angle of 45 degrees around the central axis of the balloon.
6. The integrated mapping and cryoablation catheter of any of claims 1-5, wherein the tip of the protrusion is provided with an arcuate atraumatic structure.
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CN112402005B (en) * 2020-10-21 2022-06-14 宁波胜杰康生物科技有限公司 Cavity channel cryotherapy system
CN112932647A (en) * 2021-03-09 2021-06-11 中国人民解放军总医院第一医学中心 Freezing sacculus
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