CN117017474A - A radiofrequency ablation catheter - Google Patents
A radiofrequency ablation catheter Download PDFInfo
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- CN117017474A CN117017474A CN202311227764.XA CN202311227764A CN117017474A CN 117017474 A CN117017474 A CN 117017474A CN 202311227764 A CN202311227764 A CN 202311227764A CN 117017474 A CN117017474 A CN 117017474A
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- 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
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- 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
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
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- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
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- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
- A61B2018/00648—Sensing and controlling the application of energy with feedback, i.e. closed loop control using more than one sensed parameter
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00797—Temperature measured by multiple temperature sensors
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00821—Temperature measured by a thermocouple
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
- A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
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Abstract
本发明提供一种射频消融导管，包括：导管本体、至少两个消融电极和至少两个感测组；所述导管本体的远端可弯段具有线性态和弯曲态，且于弯曲态时具有相对的内侧和外侧，所述远端可弯段用于通过所述外侧与目标对象相接触；至少两个所述消融电极沿所述远端可弯段的轴向依次间隔布置，且所述远端可弯段于弯曲态时，各所述消融电极至少部分位于所述外侧；至少两个所述感测组于所述远端可弯段上围绕所述远端可弯段的轴线呈螺旋态布置，使得所述远端可弯段呈弯曲态时，至少两个所述感测组于所述外侧与至少两个所述消融电极一一对应设置，每个所述感测组包括温度感测单元和/或压力感测单元，从而使得所述射频消融导管能够进行有效温度和/压力感测。
The present invention provides a radiofrequency ablation catheter, which includes: a catheter body, at least two ablation electrodes and at least two sensing groups; the distal bendable section of the catheter body has a linear state and a curved state, and in the curved state has The opposite inner and outer sides, the distal bendable section is used to contact the target object through the outer side; at least two of the ablation electrodes are arranged at intervals along the axial direction of the distal bendable section, and the When the distal flexible section is in a bent state, each of the ablation electrodes is at least partially located on the outside; at least two of the sensing groups are arranged on the distal flexible section around the axis of the distal flexible section. Arranged in a spiral state, such that when the distal bendable section is in a curved state, at least two of the sensing groups are arranged in correspondence with at least two of the ablation electrodes on the outside, and each of the sensing groups includes A temperature sensing unit and/or a pressure sensing unit, thereby enabling the radiofrequency ablation catheter to perform effective temperature and/or pressure sensing.
Description
Technical Field
The application relates to the technical field of medical appliances, in particular to a radio frequency ablation catheter.
Background
In recent years, radio frequency ablation has been found to treat hypertension, while it has a certain therapeutic effect in improving insulin resistance, treating heart failure, etc. The mechanism of radiofrequency ablation is to use radiofrequency electrodes to abut or approach the body tissue being treated and release radiofrequency energy. For tissues needing deep ablation, accurate attachment of the radio frequency electrode is more needed, so that radio frequency energy can be effectively exerted. Radio frequency current flows between the distal radio frequency electrode at the tissue electrode interface and a neutral ground electrode on the skin. When the rf current encounters the tissue resistance, it generates joules, which are then conduction heated due to the temperature gradient between the heated tissue in direct contact with the rf electrode and the relatively cool surrounding tissue. The formation of the rf lesions is determined by direct resistive and conductive heating of the tissue in contact with the rf electrodes, and treatment of the human tissue by thermal effects. Therefore, whether the radiofrequency electrode adheres to the wall during the operation has a decisive effect on the therapeutic effect of the radiofrequency ablation operation. Inaccurate leaning positions can cause an operation process, temperature monitoring and impedance monitoring are inaccurate, and real and effective guidance cannot be provided for operation development. Not only can other healthy tissues be irreversibly damaged, but also the real treatment purpose is difficult to achieve. Accurate localization of the lesion is required prior to ablation. The current common technology is to place an additional mapping catheter for mapping and then perform ablation treatment while ablating the electrode, and adding an additional mapping catheter for ablation treatment increases the difficulty and time of operation and increases pain and cost for patients.
Disclosure of Invention
It is an object of the present application to provide a radiofrequency ablation catheter that solves one or more of the problems of the prior art.
To solve the above problems, the present application provides a radio frequency ablation catheter, comprising: a catheter body, at least two ablation electrodes, and at least two sensing sets;
the catheter body including a distal deflectable segment having a linear state and a deflected state, the distal deflectable segment having opposite inner and outer sides in the deflected state, the distal deflectable segment for contact with a target object through the outer side;
at least two ablation electrodes are sequentially arranged at intervals along the axial direction of the distal bendable section, and when the distal bendable section is in the bent state, each ablation electrode is at least partially positioned on the outer side;
at least two sensing groups are arranged on the far-end bendable section in a spiral mode around the axis of the far-end bendable section, so that when the far-end bendable section is in the bent mode, the at least two sensing groups are arranged on the outer side in one-to-one correspondence with the at least two ablation electrodes, and each sensing group comprises a temperature sensing unit and/or a pressure sensing unit.
Optionally, in the radio frequency ablation catheter, the temperature sensing unit is a temperature measuring point formed by a thermocouple.
Optionally, in the radio frequency ablation catheter, part or all of each of the temperature sensing units is covered by a corresponding one of the ablation electrodes.
Optionally, in the radio frequency ablation catheter, the radio frequency ablation catheter includes a thermocouple assembly, the thermocouple assembly includes a first thermocouple wire and at least two second thermocouple wires, the first thermocouple wires are spirally arranged around the axis of the distal bendable section, the at least two second thermocouple wires are sequentially arranged at intervals along the extending direction of the second thermocouple wires, the extending direction of each first thermocouple wire is parallel to the extending direction of the first thermocouple wire, and a temperature measuring point is formed between the distal end portion of the at least two second thermocouple wires and the first thermocouple wires.
Optionally, in the radio frequency ablation catheter, the first thermocouple wire is an insulated copper wire, and the second thermocouple wire is an insulated constantan wire.
Optionally, in the radiofrequency ablation catheter, the thermocouple assembly is secured to an exterior surface of the distal deflectable segment by at least one of:
a. an outer surface bonded to the distal deflectable segment;
b. is secured to the outer surface of the distal deflectable segment by a flexible insulating material;
c. the outer surface of the distal deflectable segment has a first mounting groove that matches the shape of the thermocouple assembly, and the thermocouple assembly is embedded within the first mounting groove.
Optionally, in the radiofrequency ablation catheter, when the thermocouple assembly is fixed by the flexible insulating material, an adhesive is filled between the flexible insulating material and an outer surface of the distal bendable section.
Optionally, in the radio frequency ablation catheter, a distance between the pressure sensing unit and the ablation electrode correspondingly arranged does not exceed a set distance.
Optionally, in the radio frequency ablation catheter, the set distance is not greater than 1mm.
Optionally, in the radio frequency ablation catheter, the outer surface of the distal bendable section has at least two second mounting grooves for mounting the pressure sensing units, respectively, and the surface of each pressure sensing unit is level with the outer surface of the distal bendable section.
Optionally, in the radiofrequency ablation catheter, the radiofrequency ablation catheter further comprises a control member disposed within the distal bendable section in a direction parallel to an axis of the distal bendable section, the control member having the linear state and the bent state, the distal bendable section varying with a change in a morphology of the control member.
Optionally, in the radio frequency ablation catheter, the distal bendable section has a first channel for the control member to be disposed in, and the control member is in close-fitting connection with the distal bendable section in the first channel.
Optionally, in the radio frequency ablation catheter, the control member is disposed in the first channel, and the first channel is filled with glue; or,
the first channel is formed after the control member is preset and has a diameter that matches an outer diameter of the control member.
In summary, the plurality of sensing groups are spirally arranged, so that after the bendable section at the distal end of the catheter is bent, each sensing unit is positioned at the outer side of the catheter, the outer side is one side of the catheter for performing ablation, the temperature sensing can be performed in the process of measuring the real temperature of the inner wall of the blood vessel, and real and effective data guidance is provided for the development of an operation, so that the probability of treating a target tissue is improved, the inner wall of the blood vessel is always ablated at a safe temperature in the process of ablation, and the blood vessel wall is not damaged; in addition, through carrying out pressure sensing in catheter ablation one side, both can guarantee that the catheter has certain holding power to the blood vessel inner wall, do not cause the damage of blood vessel inner wall, can judge again that the ablation electrode melts one side and carries out effectual subsides with the blood vessel wall and lean on, the real-time supervision of pressure also is favorable to guaranteeing the operation in-process, provides and lasts stable holding power to guarantee to ablate electrode and the good subsides of blood vessel inner wall keep, reduce because of patient's physiology changes and cause ablation electrode and blood vessel inner wall to lean on the change of position.
Drawings
Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present application and do not constitute any limitation on the scope of the present application. Wherein:
FIG. 1 is a schematic illustration of a thermocouple assembly in accordance with an embodiment of the present application in a side-by-side positioning stage with a distal deflectable segment in a linear state;
FIG. 2 is a schematic view of a distal portion of a catheter in a linear state of a distal deflectable segment according to an embodiment of the present application;
FIG. 3 is an enlarged view of portion A of FIG. 2;
FIG. 4 is a top view of a distal portion of a catheter in a bent state of a distal deflectable segment according to an embodiment of the application;
FIG. 5 is a side view of a distal portion of a catheter with a distal deflectable segment in a deflected state, in accordance with an embodiment of the present application;
FIG. 6 is a schematic view of an arrangement of the interior of a catheter body according to an embodiment of the present application;
the various labels in the figures are described below:
100-radiofrequency ablation catheter; 101-a distal portion;
121-a distal bendable section; 122-an ablation assembly; 123-a pressure sensing component; 130-thermocouple assembly; 131—a first thermocouple wire; 132—a second thermocouple wire; 133-a temperature sensing assembly;
122 a-a first ablation electrode; 122 b-a second ablation electrode; 122 c-a third ablation electrode; 122 d-a fourth ablation electrode;
123 a-a first pressure sensor; 123 b-a second pressure sensor; 123 c-a third pressure sensor; 123 d-fourth pressure sensor;
133 a-a first temperature measurement point; 133 b-a second temperature measurement point; 133 c-a third temperature measurement point; 133 d-a fourth temperature measurement point;
1211-third lumen; 1212-a second channel; 1213-a first lumen;
124-control means; 125-brine pipe; 1221-lead wire for ablation electrode.
Detailed Description
The application aims to provide a radio frequency ablation catheter which is used for solving the problems that in the prior art, the temperature monitoring on the ablation side of an ablation electrode is inaccurate, and meanwhile, the whole form of a distal treatment assembly cannot be judged in the ablation process, so that the ablation side of the ablation electrode and the inner wall of a blood vessel cannot be guaranteed to have proper supporting force and be well attached. In particular, the present technology provides a radiofrequency ablation catheter having a multi-point temperature measurement function and/or a multi-point support force monitoring function, and being changeable between a linear state (e.g., a generally straight shape) and a curved state (e.g., a radially expanded shape, a generally spiral/helical shape, an expanded lasso shape, a J shape, etc.).
The radio frequency ablation catheter provided by the application can be suitable for ablation at any suitable position in a blood vessel, such as the inner wall of an artery (for example, a renal artery, an ovarian artery, a testicular artery, an external iliac artery, an internal pudendum artery, a uterine artery, an abdominal artery, an superior mesenteric artery, a hepatic artery, a splenic artery, a gastric artery, a pancreatic artery and/or related ganglia branches, and the like).
The application will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the application more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the application. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, features defining "first", "second", "third" may explicitly or implicitly include one or at least two such features, one end and another end and proximal and distal ends generally refer to the respective two portions, which are not only included in the present document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not limiting, but "proximal" generally refers to an end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to an end that enters the patient first. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise.
Referring to fig. 1-4, an embodiment of the present application provides a radiofrequency ablation catheter 100, the radiofrequency ablation catheter 100 including a catheter body, an ablation assembly 122, and a sensing assembly.
The catheter body includes a distal deflectable segment 121, the ablation assembly 122, and the sensing assembly collectively constructing the distal portion 101 of the radiofrequency ablation catheter 100.
The distal deflectable segment 121 has a linear state and a deflected state, the distal deflectable segment 121 having opposite inner and outer sides when in the deflected state, the distal deflectable segment 121 being configured to contact a target object through the outer sides. It will be appreciated that when the distal deflectable segment 121 is in a deflected state, its concave side is its inner side and its convex side is its outer side.
The ablation assembly 122 includes at least two ablation electrodes, at least two ablation electrodes are sequentially spaced apart along the axial direction of the distal bendable section 121, and each ablation electrode is at least partially located at the outer side when the distal bendable section 121 is in the bent state, and the ablation electrodes may be ring electrodes sleeved on the distal bendable section 121.
The sensing assembly comprises at least two sensing groups, each sensing group comprises a temperature sensing unit and/or a pressure sensing unit, and the at least two sensing groups are arranged on the distal bendable section 121 in a spiral mode around the axis of the distal bendable section 121, so that when the distal bendable section 121 is in the bent mode, the at least two sensing groups are arranged on the outer side in one-to-one correspondence with the at least two ablation electrodes.
Alternatively, it may be understood that the sensing assembly includes a temperature sensing assembly 133 and/or a pressure sensing assembly 123, the temperature sensing assembly 133 includes at least two temperature sensing units, the pressure sensing assembly 123 includes at least two pressure sensing units, when the sensing assembly includes the temperature sensing assembly 133 and the pressure sensing assembly 123, at least two temperature sensing units and at least two pressure sensing units are disposed in one-to-one correspondence, two by two form one of the sensing groups, and when the sensing assembly includes one of the temperature sensing assembly 133 and the pressure sensing assembly 123, one of the temperature sensing units or one of the pressure sensing units forms one of the sensing groups alone.
The radio frequency ablation catheter 100 provided by the embodiment of the application has the advantages that the plurality of sensing groups are spirally arranged, so that after the bendable section 121 at the distal end of the catheter is bent, temperature sensing and/or pressure sensing are performed on the outer side of the catheter, the outer side is one side of the catheter for performing ablation, the temperature sensing can be performed in the temperature sensing process to effectively monitor the real temperature of the inner wall of the blood vessel in the ablation process, and real and effective data guidance is provided for the development of an operation, so that the probability of treating a target tissue is improved, the inner wall of the blood vessel is always ablated at a safe temperature in the ablation process, and the blood vessel wall is not damaged; in addition, through carrying out pressure sensing in catheter ablation one side, both can guarantee that the catheter has certain holding power to the blood vessel inner wall, do not cause the damage of blood vessel inner wall, can judge again that the ablation electrode melts one side and carries out effectual subsides with the blood vessel wall and lean on, the real-time supervision of pressure also is favorable to guaranteeing the operation in-process, provides and lasts stable holding power to guarantee to ablate electrode and the good subsides of blood vessel inner wall keep, reduce because of patient's physiology changes and cause ablation electrode and blood vessel inner wall to lean on the change of position.
In some embodiments, each of the temperature sensing units employs a temperature sensor, and in this embodiment, preferably, the temperature sensing unit is a temperature measuring point formed by a thermocouple. In addition, in some embodiments, at least two of the temperature sensing units are respectively provided, that is, at least two temperature measuring points are formed by at least two thermocouples respectively provided to constitute at least two of the temperature sensing units. Preferably, in this embodiment, the radiofrequency ablation catheter 100 includes a thermocouple assembly, i.e., the temperature sensing assembly 133 is a thermocouple assembly. The thermocouple assembly comprises a first thermocouple wire 131 and at least two second thermocouple wires 132, wherein the first thermocouple wires 131 are spirally arranged around the axis of the distal bendable section 121, the at least two second thermocouple wires 132 are sequentially arranged at intervals along the extending direction of the second thermocouple wires 132, the extending direction of each first thermocouple wire 131 is parallel to the extending direction of the first thermocouple wire 131, and a temperature measuring point is respectively formed between the distal end portion 101 of the at least two second thermocouple wires 132 and the first thermocouple wire 131. When at least two temperature measuring points are formed, the second thermocouple wires 132 are shared, so that the manufacturing process of the catheter is optimized, and the use of raw materials is greatly saved.
It should be noted that the distal bendable section 121 is capable of bending when subjected to an external force, and thus the axis of the distal bendable section 121 is not limited to a straight line, but is understood to be capable of bending as the distal bendable section 121 is bent.
For example, the thermocouple assembly 130 may include between 2 and about 8 temperature measurement points, or between 2 and about 6 temperature measurement points, or between 2 and about 4 temperature measurement points, or about 4 temperature measurement points along the extension of the first thermocouple wire 131, depending on the placement of the ablation electrode on the ablation electrode. As shown in fig. 1, the ablation assembly 122 includes four ablation electrodes, a first ablation electrode 122a, a second ablation electrode 122b, a third ablation electrode 122c, and a fourth ablation electrode 122d, respectively.
In some embodiments, the temperature measurement points may be equally spaced along the length L1 of the distal bendable section 121. However, in other embodiments, the number, size, and arrangement (e.g., spacing) of the temperature measurement points may vary. For example, the first temperature measurement point 133a may have a first size (e.g., a first length) and the second temperature measurement point 133b may have a second size (e.g., a second length) different from the first size, and/or the first temperature measurement point 133a and the second temperature measurement point 133b may be spaced apart by a distance different from the distance by which the second temperature measurement point 133b and the third temperature measurement point 133c are spaced apart, and the temperature measurement points may be specifically arranged according to the actual situation.
Alternatively, the first thermocouple wire 131 may be a nickel wire, a silver wire, or the like coated with silver, a material having a coating with good biocompatibility thereon, and the second thermocouple wire 132 may be a copper wire, a material having a coating with good biocompatibility thereon, or the like. In a particular embodiment, the thermocouple assembly 130 may be a T-type thermocouple, the first thermocouple wire 131 may be an insulated copper wire, the copper surface may be coated with a biocompatible material such as gold or platinum, and the second thermocouple wire 132 may be an insulated constantan wire, in which embodiment the thermocouple assembly 130 may measure temperatures in a temperature range of about-200 ℃ to about 350 ℃. The first thermocouple wire 131 and the second thermocouple wire 132 are insulated by a coating material with good biocompatibility.
Preferably, each of said temperature sensing elements is partially or fully covered by a respective one of said ablation electrodes, which is advantageous in ensuring that the temperature monitored is that of the ablation side and not that of the non-ablation side. After the temperature sensing units are positioned on the distal bendable section 121, an ablation electrode (a ring electrode as described above) is sleeved on the distal bendable section 121, and the sleeved position ensures that the corresponding temperature sensing units are completely covered or partially covered.
The pressure sensing units may specifically be pressure sensors, which in some embodiments may be equally spaced along the length L1 of the treatment assembly 110. However, in other embodiments, the number, size, and arrangement (e.g., spacing) of the pressure sensors may vary. As shown in fig. 1, the pressure sensing assembly includes four pressure sensors, namely, a first pressure sensor 123a, a second pressure sensor 123b, a third pressure sensor 123c, and a fourth pressure sensor 123 d. For example, the first pressure sensor 123a may have a first size (e.g., a first length) and the second pressure sensor 123b may have a second size (e.g., a second length) different from the first size, and/or the first pressure sensor 123a and the second pressure sensor 123b may be spaced apart by a distance different from the distance by which the second pressure sensor 123b and the third pressure sensor 123c are spaced apart, and the pressure sensors 123 may be specifically arranged according to the actual situation.
In this embodiment, preferably, each sensing set includes both the temperature sensing unit and the pressure sensing unit, that is, in this embodiment, when the distal bendable section 121 is in a bent state, a temperature measuring point and a temperature sensor are correspondingly disposed on the outer side of each ablation electrode. Preferably, the distance between each pressure sensing unit and the corresponding ablation electrode does not exceed a set distance, the set distance is related to factors such as the pipe diameter of the distal bendable section 121, the set distance should not be greater than 1mm in most application scenarios, and the design can ensure that the pressure monitored at the position can be approximately represented by the pressure of the ablation electrode and the inner wall of the blood vessel to the greatest extent, so that effective data guidance is provided for the adjustment of the shape of the distal bendable section 121 of the catheter and the adjustment of the position.
Thermocouple assembly 130 may be coupled or attached to distal deflectable segment 121 at one or more locations axially of distal deflectable segment 121 using an adhesive (e.g., a thermal bond layer), a structural fit, and/or other suitable attachment mechanism (e.g., a sleeve, etc.). That is, the thermoelement assembly 130 may be secured to the outer surface of the distal bendable section 121 by at least one of the following:
a. an outer surface bonded to the distal deflectable segment 121;
b. is secured to the outer surface of the distal deflectable segment 121 by a flexible insulating material;
c. the outer surface of the distal deflectable segment 121 has a first mounting groove that matches the shape of the thermocouple assembly, which is embedded within the first mounting groove.
Specifically, in one embodiment, the thermocouple assembly is spirally wound on the distal bendable section 121, and a first mounting groove with a shape matching that of the thermocouple assembly is provided on the distal bendable section 121, which just meets the requirement that the thermocouple wire is embedded therein, and to ensure the connection stability, an adhesive may be used to further fix the thermocouple assembly in the first mounting groove. In another embodiment, the thermocouple assembly may be screwed onto the distal deflectable segment 121 with a relatively high molecular material that is flexible and insulating, such as a polyethylene terephthalate (PET) heat shrink tubing or other shrink tubing material, and preferably, when the thermocouple assembly is secured with the flexible insulating material, an adhesive is filled between the flexible insulating material and the outer surface of the distal deflectable segment 121 to prevent blood from accumulating and/or clotting between the flexible insulating material and the distal deflectable segment 121.
Preferably, the outer surface of the distal bendable section 121 has at least two second mounting grooves for mounting one of the pressure sensing units, and the surface of each of the pressure sensing units is flush with the outer surface of the distal bendable section 121, so as to ensure that the two contact the inner wall of the blood vessel at the same time as much as possible.
In the present application, the method of arranging the wire of the ablation electrode, the control member for controlling the morphological change of the distal bendable section 121, the saline tube, and the wire of the pressure sensor for monitoring the magnitude of the supporting force in the catheter body is not unique, which has a great relation with the catheter body using a single lumen tube or a multi-lumen tube, or a single lumen tube or a multi-lumen tube with a braided structure. In the following description, an embodiment of the present application describes an arrangement of an ablation electrode lead, a saline tube, and a control member within a catheter body, but the arrangement is not limiting of the present application.
As shown in fig. 5-6, the distal deflectable segment 121 is a three lumen tube without a braided structure, a first lumen 1213 for placement of the control member 124, a second lumen 1212 for passage of saline, a saline tube 125, and a third lumen 1211 for passage of the lead 1221 of the ablation electrode. In this embodiment, the control member is disposed in the distal bendable section 121 along a direction parallel to the axis of the distal bendable section 121, the control member 124 has the linear state and the bending state, the distal bendable section 121 changes along with the change of the shape of the control member 124, specifically, the control member 124 is made of an alloy material (such as a nickel-titanium alloy material) with a shape memory function, which can change its shape under the action of a force, and can recover its original shape when it is not stressed, so that the change of the shape of the distal bendable section 121 can be controlled.
Preferably, the control member 124 is tightly connected to the distal bendable section 121 in the first channel 1213, and the tight fitting is beneficial to ensure that the distal bendable section 121 has good synchronization during the deformation process of the control member 124, so that the surface of the distal bendable section 121 is not kinked, and the surface of the distal bendable section 121 is smooth. In the actual preparation process, after the control member is disposed in the first cavity 1213, the first cavity 1213 is filled with glue; alternatively, the first channel 1213 is formed after the control member 124 is pre-positioned, having a diameter that matches the outer diameter of the control member 124. That is, glue may be added or a molded control member 124 may be pre-placed during the preparation of the multi-lumen tube to maintain the control member 124 in close apposition with the distal deflectable segment 121.
Since the distal deflectable segment 121 has good flexibility during actual surgery, the change in the morphology of the distal deflectable segment 121 can be controlled by the control member 124. During vascular access, the distal deflectable segment 121 is maintained in a linear configuration by the control member 124, while the thermocouple assembly 130 is held in close apposition to the distal deflectable segment 121 without affecting catheter access to the vessel and reaching the target tissue. When the target tissue is reached, the distal deflectable segment 121 is gradually changed from the linear state to the deflected state by adjustment of the control member 124. At this time, the ablation electrode on the distal bendable section 121 is also gradually abutted against the inner wall of the blood vessel, the pressure displayed on the pressure sensor is also gradually increased, and when the pressure on the pressure sensor is greater than 0.01N to 2N, the ablation electrode is considered to provide a good supporting force, and at this time, the ablation electrode is also in good abutment against the inner wall of the blood vessel. When radio frequency energy is connected, the ablation electrode can ablate the target leaning position, and as the thermocouple assembly 130 is arranged on the ablation side of the ablation electrode, the temperature of the ablation electrode leaning against the inner wall of the blood vessel can be accurately monitored, so that the safety of an operation is guaranteed, and meanwhile, real and effective data guidance can be provided for deep ablation.
In addition, the radiofrequency ablation catheter provided by the embodiment of the application can further comprise a handle and a stay wire, wherein the distal end of the stay wire is connected with the control member 124, the proximal end of the stay wire is connected with a control knob on the handle, and the control knob is rotated or moved to drive the stay wire to move along the axial direction of the catheter body so as to change the bending shape of the control member 124. The proximal end of the handle may further be provided with a saline filling port, an electrical connection interface, and the like, which are not described herein.
In summary, the plurality of sensing groups of the radiofrequency ablation catheter provided by the embodiment of the application are spirally arranged, so that after the bendable section at the distal end of the catheter is bent, each sensing unit is positioned at the outer side of the catheter, the outer side is one side of the catheter for ablation, the temperature sensing can be performed in the process of measuring the temperature, so that the real temperature of the inner wall of the blood vessel in the process of ablation can be effectively monitored, real and effective data guidance is provided for the development of surgery, the probability of treating a target tissue is improved, the inner wall of the blood vessel can be always ablated at a safe temperature in the process of ablation, and the blood vessel wall is not damaged; in addition, through carrying out pressure sensing in catheter ablation one side, both can guarantee that the catheter has certain holding power to the blood vessel inner wall, do not cause the damage of blood vessel inner wall, can judge again that the ablation electrode melts one side and carries out effectual subsides with the blood vessel wall and lean on, the real-time supervision of pressure also is favorable to guaranteeing the operation in-process, provides and lasts stable holding power to guarantee to ablate electrode and the good subsides of blood vessel inner wall keep, reduce because of patient's physiology changes and cause ablation electrode and blood vessel inner wall to lean on the change of position.
It should also be appreciated that while the present application has been disclosed in the context of a preferred embodiment, the above embodiments are not intended to limit the application. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present application still fall within the scope of the technical solution of the present application.
Claims (13)
1. A radio frequency ablation catheter, comprising: a catheter body, at least two ablation electrodes, and at least two sensing sets;
the catheter body including a distal deflectable segment having a linear state and a deflected state, the distal deflectable segment having opposite inner and outer sides in the deflected state, the distal deflectable segment for contact with a target object through the outer side;
at least two ablation electrodes are sequentially arranged at intervals along the axial direction of the distal bendable section, and when the distal bendable section is in the bent state, each ablation electrode is at least partially positioned on the outer side;
at least two sensing groups are arranged on the far-end bendable section in a spiral mode around the axis of the far-end bendable section, so that when the far-end bendable section is in the bent mode, the at least two sensing groups are arranged on the outer side in one-to-one correspondence with the at least two ablation electrodes, and each sensing group comprises a temperature sensing unit and/or a pressure sensing unit.
2. The radiofrequency ablation catheter of claim 1, wherein the temperature sensing unit is a temperature measurement point formed by a thermocouple.
3. The radiofrequency ablation catheter of claim 1 or 2, wherein part or all of each of said temperature sensing units is covered by a respective said ablation electrode.
4. The radiofrequency ablation catheter of claim 2, wherein the radiofrequency ablation catheter comprises a thermocouple assembly, the thermocouple assembly comprises a first thermocouple wire and at least two second thermocouple wires, the first thermocouple wires are arranged in a spiral mode around the axis of the distal bendable section, the at least two second thermocouple wires are sequentially arranged at intervals along the extending direction of the second thermocouple wires, the extending direction of each first thermocouple wire is parallel to the extending direction of the first thermocouple wire, and a temperature measuring point is formed between the distal end portion of each second thermocouple wire and the first thermocouple wire.
5. The radiofrequency ablation catheter of claim 4, wherein the first thermocouple wire is an insulated copper wire and the second thermocouple wire is an insulated constantan wire.
6. The radiofrequency ablation catheter of claim 5, wherein the thermocouple assembly is secured to an exterior surface of the distal deflectable segment by at least one of:
a. an outer surface bonded to the distal deflectable segment;
b. is secured to the outer surface of the distal deflectable segment by a flexible insulating material;
c. the outer surface of the distal deflectable segment has a first mounting groove that matches the shape of the thermocouple assembly, and the thermocouple assembly is embedded within the first mounting groove.
7. The radiofrequency ablation catheter of claim 6, wherein the thermocouple assembly, when secured by the flexible insulating material, fills an adhesive between the flexible insulating material and an outer surface of the distal deflectable segment.
8. The radiofrequency ablation catheter of claim 1, wherein a distance between the pressure sensing unit and the correspondingly disposed ablation electrode does not exceed a set distance.
9. The radiofrequency ablation catheter of claim 8, wherein the set distance is no greater than 1mm.
10. The radiofrequency ablation catheter of claim 8, wherein the outer surface of the distal deflectable segment has at least two second mounting slots for mounting a respective one of the pressure sensing units, and wherein the surface of each of the pressure sensing units is flush with the outer surface of the distal deflectable segment.
11. The radiofrequency ablation catheter of claim 1, further comprising a control member disposed within the distal deflectable segment in a direction parallel to an axis of the distal deflectable segment, the control member having the linear state and the curved state, the distal deflectable segment varying with a change in the morphology of the control member.
12. The radiofrequency ablation catheter of claim 11, wherein the distal deflectable segment has a first lumen for placement of the control member, the control member being in close-fitting connection with the distal deflectable segment within the first lumen.
13. The radiofrequency ablation catheter of claim 12, wherein the control member, after being disposed in the first lumen, the first lumen is filled with glue; or,
the first channel is formed after the control member is preset and has a diameter that matches an outer diameter of the control member.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311227764.XA CN117017474A (en) | 2023-09-21 | 2023-09-21 | A radiofrequency ablation catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311227764.XA CN117017474A (en) | 2023-09-21 | 2023-09-21 | A radiofrequency ablation catheter |
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| Publication Number | Publication Date |
|---|---|
| CN117017474A true CN117017474A (en) | 2023-11-10 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311227764.XA Withdrawn CN117017474A (en) | 2023-09-21 | 2023-09-21 | A radiofrequency ablation catheter |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119587151A (en) * | 2025-02-10 | 2025-03-11 | 浙江伽奈维医疗科技有限公司 | A temperature measuring device for ablation electrode |
| WO2025177256A1 (en) * | 2024-02-23 | 2025-08-28 | Auris Health, Inc. | Integrations of sensing elements and access lumens for endoscopes |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5782828A (en) * | 1996-12-11 | 1998-07-21 | Irvine Biomedical, Inc. | Ablation catheter with multiple flexible curves |
| US5823955A (en) * | 1995-11-20 | 1998-10-20 | Medtronic Cardiorhythm | Atrioventricular valve tissue ablation catheter and method |
| US6078830A (en) * | 1997-10-01 | 2000-06-20 | Ep Technologies, Inc. | Molded catheter distal end assembly and process for the manufacture thereof |
| WO2000036987A1 (en) * | 1998-12-23 | 2000-06-29 | Daig Corporation | Dual sensor ablation catheter |
| US6511478B1 (en) * | 2000-06-30 | 2003-01-28 | Scimed Life Systems, Inc. | Medical probe with reduced number of temperature sensor wires |
| CN203885613U (en) * | 2014-03-21 | 2014-10-22 | 上海微创电生理医疗科技有限公司 | Radiofrequency ablation catheter and conveying system thereof |
| CN106308922A (en) * | 2015-06-30 | 2017-01-11 | 四川锦江电子科技有限公司 | Multi-electrode ablation device |
| CN108720919A (en) * | 2017-04-24 | 2018-11-02 | 四川锦江电子科技有限公司 | A kind of ablation catheter with flexible distal |
-
2023
- 2023-09-21 CN CN202311227764.XA patent/CN117017474A/en not_active Withdrawn
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5823955A (en) * | 1995-11-20 | 1998-10-20 | Medtronic Cardiorhythm | Atrioventricular valve tissue ablation catheter and method |
| US5782828A (en) * | 1996-12-11 | 1998-07-21 | Irvine Biomedical, Inc. | Ablation catheter with multiple flexible curves |
| US6078830A (en) * | 1997-10-01 | 2000-06-20 | Ep Technologies, Inc. | Molded catheter distal end assembly and process for the manufacture thereof |
| WO2000036987A1 (en) * | 1998-12-23 | 2000-06-29 | Daig Corporation | Dual sensor ablation catheter |
| US6511478B1 (en) * | 2000-06-30 | 2003-01-28 | Scimed Life Systems, Inc. | Medical probe with reduced number of temperature sensor wires |
| CN203885613U (en) * | 2014-03-21 | 2014-10-22 | 上海微创电生理医疗科技有限公司 | Radiofrequency ablation catheter and conveying system thereof |
| CN106308922A (en) * | 2015-06-30 | 2017-01-11 | 四川锦江电子科技有限公司 | Multi-electrode ablation device |
| CN108720919A (en) * | 2017-04-24 | 2018-11-02 | 四川锦江电子科技有限公司 | A kind of ablation catheter with flexible distal |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025177256A1 (en) * | 2024-02-23 | 2025-08-28 | Auris Health, Inc. | Integrations of sensing elements and access lumens for endoscopes |
| CN119587151A (en) * | 2025-02-10 | 2025-03-11 | 浙江伽奈维医疗科技有限公司 | A temperature measuring device for ablation electrode |
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Application publication date: 20231110 |