CN113995503A - Radio frequency ablation catheter device - Google Patents

Radio frequency ablation catheter device Download PDF

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Publication number
CN113995503A
CN113995503A CN202111394995.0A CN202111394995A CN113995503A CN 113995503 A CN113995503 A CN 113995503A CN 202111394995 A CN202111394995 A CN 202111394995A CN 113995503 A CN113995503 A CN 113995503A
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ablation
catheter body
catheter
electrode
ablation member
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刘广志
江挺益
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Suzhou Rainmed Medical Technology Co Ltd
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Suzhou Rainmed Medical Technology Co Ltd
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Priority to CN202111394995.0A priority Critical patent/CN113995503A/en
Priority to PCT/CN2022/073458 priority patent/WO2023092851A1/en
Publication of CN113995503A publication Critical patent/CN113995503A/en
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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
    • A61B18/04Surgical 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
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B2018/00404Blood vessels other than those in or around the heart
    • 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
    • A61B2018/00571Surgical 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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  • Surgery (AREA)
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Abstract

The present specification provides a radiofrequency ablation catheter device comprising: the catheter comprises a catheter body, wherein a plurality of side holes are formed in the peripheral wall surface of the catheter body; an ablation assembly comprising: a plurality of ablation members, a proximal end of the ablation members being disposed inside the catheter body; electrodes disposed on the distal end, the electrodes on the plurality of ablation members being spaced apart along an axial direction of the catheter body, and projections of the plurality of electrodes on a cross section along an axial direction of the catheter body along the axial direction of the catheter body being spaced apart along a circumferential direction of the plane; the catheter apparatus is configured to: when the ablation component and the catheter body move relatively along the axial direction of the catheter body, the ablation component can slide along the side hole, and the ablation component can be switched between the working state and the containing state. The radiofrequency ablation catheter device provided by the specification is simple in structure, can adapt to blood vessels with different diameters, and effectively ensures simultaneous adherence of multiple electrodes.

Description

Radio frequency ablation catheter device
Technical Field
The application relates to the technical field of medical instruments, in particular to a radio frequency ablation catheter device.
Background
The renal sympathetic and afferent nerves are located within and in close proximity to the renal artery wall and are critical for the initiation and maintenance of systemic hypertension. Denervation is a method of treating refractory hypertension by accessing the blood vessels through an ablation device with electrodes to the target site of ablation and ablating the hyperactive renal artery sympathetic nerves for the purpose of blood pressure regulation.
Currently, among the methods for renal denervation for the treatment of hypertension, a representative method is the use of a catheter. Denervation using a catheter is achieved by: a catheter is inserted into a part of the body so that a distal end portion of the catheter enters a renal artery along a blood vessel, and an electrode provided at the distal end portion of the catheter generates heat by Radio Frequency (RF) energy or the like to block a sympathetic nerve around the renal artery.
As described above, in the denervation process using the catheter, on one hand, the catheter needs to be able to move freely along the inner wall of the blood vessel, and on the other hand, the electrodes need to adhere well to the wall, so as to achieve a good therapeutic effect.
In the prior art, the structure of such catheters is designed to be complicated in such a case that the head is expanded when the distal end portion of the catheter reaches the operation site, thereby bringing the electrodes close to the inner wall of the blood vessel; in addition, the problem that the electrodes cannot adhere to the wall at the same time during the operation still occurs, and the operation effect is influenced. In addition, the diameters of blood vessels of a human body are different from person to person, and the diameters of the blood vessels in the human body are different at different ablation parts, so that the existing catheter has poor adaptability to the blood vessels with different diameters, and the adaptability adjustment of the expansion range of the head of the catheter according to the diameters of the blood vessels cannot be carried out.
Disclosure of Invention
In order to solve at least one technical problem existing in the prior art, the application provides a radiofrequency ablation catheter device which is simple in structure, can adapt to blood vessels with different diameters, and can effectively ensure that a plurality of electrodes adhere to the wall at the same time.
In order to achieve the above purpose, the technical solution provided by the present application is as follows:
a radio frequency ablation catheter device comprising:
the catheter comprises a catheter body, wherein a plurality of side holes are formed in the peripheral wall surface of the catheter body;
an ablation assembly comprising: a plurality of ablation members having opposite proximal and distal ends in a lengthwise extension thereof, the proximal ends being disposed inside the catheter body; an electrode disposed on the distal end, a plurality of electrodes on the ablation member being spaced apart along an axial direction of the catheter body, a plurality of projections of the electrodes on the cross section along the axial direction of the catheter body being spaced apart along a circumferential direction of the plane in a cross section perpendicular to the axial direction of the catheter body;
the catheter apparatus is configured to: when the ablation component and the catheter body move relatively along the axial direction of the catheter body, the ablation component can slide along the side hole, and the ablation component can be switched between a working state that the electrode extends out of the catheter body and a containing state that the electrode is retracted.
In a preferred embodiment, when the ablation assembly is in the accommodated state, the electrode at the distal end of the ablation member is in close contact with the outer circumferential wall surface of the catheter body.
As a preferred embodiment, one of the side hole and the electrode is provided with a stopper for limiting the entry of the electrode from the side hole into the interior of the catheter body.
In a preferred embodiment, the outer dimension of the electrode is larger than the outer dimension of the side hole.
In a preferred embodiment, the electrode at the distal end of the ablation member is receivable within the catheter body when the ablation assembly is in the received state.
As a preferred embodiment, a guiding mechanism for forming a channel is arranged in the catheter body, when the ablation assembly is in the accommodating state, all the ablation components are accommodated in the channel, and when the ablation assembly is in the working state, the channel can guide the ablation components in the channel towards the side hole.
As a preferred embodiment, the catheter body has a solid construction, the channel is formed by a slot opening towards the interior of the catheter body at a location along the side aperture, and the ablation member is disposed within the channel.
In a preferred embodiment, the outer dimension of the electrode is smaller than the outer dimension of the side hole.
In a preferred embodiment, the ablation member is made of a material having a resiliency, and the distal end of the ablation member has a supporting force that promotes expansion of the distal end in response to an axial force applied to the ablation member or the catheter body.
As a preferred embodiment, in the stowed condition, the ablation member is configured in a curvilinear configuration expanding away from the axis of the catheter body toward the side aperture from the proximal end to the distal end.
As a preferred embodiment, the ablation assembly comprises: an inner tube disposed inside the catheter body, the proximal ends of the ablation members each being connected to the inner tube;
when the inner tube moves relative to the catheter body towards the proximal direction of the ablation member, the ablation assembly is in a storage state, and when the inner tube moves relative to the catheter body towards the distal direction of the ablation member, the ablation assembly is in an operating state.
In a preferred embodiment, the ablation member is an electrically conductive material, and the electrode is electrically connected to an external radio frequency device through the ablation member.
As a preferred embodiment, the ablation member has a lumen, and the catheter device includes: the ablation lead is arranged in the cavity, and the electrode is electrically connected with external radio frequency equipment through the ablation lead.
In a preferred embodiment, the ablation member is made of an electrically conductive material, the electrode is electrically connected with an external radio frequency device through the ablation member, the ablation members are connected with each other to form an electrically conductive wire bundle, the ablation assembly is in a storage state when the electrically conductive wire bundle moves towards the proximal direction of the ablation member relative to the catheter body, and the ablation assembly is in an operation state when the electrically conductive wire bundle moves towards the distal direction of the ablation member relative to the catheter body.
As a preferred embodiment, the catheter apparatus comprises: the handle is provided with an operating part, and the handle can control the relative movement of the ablation component and the catheter body in the axial direction of the catheter body through the operating part.
Has the advantages that:
the radiofrequency ablation catheter device provided by the embodiment of the application can realize that the electrode is tightly attached to the inner wall of the blood vessel to act on the nerve of the corresponding position, and can meet the requirement that the electrode can conveniently move in the blood vessel without damaging the blood vessel wall. The plurality of electrodes are distributed at intervals along the axial direction of the catheter body, excessive ablation on a certain section of the blood vessel cannot be caused, meanwhile, on the section perpendicular to the axial direction of the catheter body, projections of the plurality of electrodes falling on the section along the axial direction of the catheter body are distributed at intervals along the circumferential direction of the section, and renal nerves can be effectively removed in the circumferential direction of the blood vessel.
In addition, the electrode is arranged at the distal end of the ablation member, and when the ablation member slides along the side hole and expands outwards, the sliding distance of the ablation member relative to the side hole can be adjusted, so that the adherence operation can be completed no matter what the diameter of the blood vessel is. Therefore, when the catheter needs to adapt to a large-diameter or small-diameter blood vessel, the relative movement distance of the ablation component and the catheter body is controlled to achieve the purpose of adjustment.
Specific embodiments of the present application are disclosed in detail with reference to the following description and drawings, indicating the manner in which the principles of the application may be employed. It should be understood that the embodiments of the present application are not so limited in scope.
Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments, in combination with or instead of the features of the other embodiments.
It should be emphasized that the term "comprises/comprising" when used herein, is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps or components.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without inventive labor.
Fig. 1 is a schematic structural view of a radiofrequency ablation catheter device provided in one embodiment of the present description;
FIG. 2 is a schematic structural view of an ablation assembly provided in accordance with an embodiment of the present disclosure;
fig. 2A is a schematic structural view of an ablation assembly provided in an embodiment of the present disclosure in a stowed state;
fig. 2B is a side view of a target anatomy when an ablation assembly is in a stowed state as provided by one embodiment of the present description;
fig. 2C is a schematic structural view of an ablation assembly provided in accordance with an embodiment of the present disclosure in an operative position;
FIG. 2D is a side view of a target anatomy with an ablation assembly in an operative state as provided by one embodiment of the present description;
fig. 3 is a schematic structural view of a radiofrequency ablation catheter device provided in accordance with another embodiment of the present disclosure (handle not shown);
fig. 4 is a schematic structural view of a radiofrequency ablation catheter device provided in accordance with another embodiment of the present disclosure (handle not shown);
FIG. 4A is a schematic cross-sectional view taken along A-A of FIG. 4;
fig. 4B is a schematic cross-sectional view taken along B-B in fig. 4.
Description of reference numerals:
1. a catheter body; 11. a peripheral wall surface; 12. a side hole; 2. an ablation member; 21. a distal end; 22. a proximal end; 3. an electrode; 4a, a first channel; 4b, a second channel; 4c, a third channel; 4d, a fourth channel; 5. a sheath tube; 6. an inner tube; 7. a compliant structure; 8. a handle; 81. an operation section; 9. the wall of the blood vessel.
Detailed Description
While the invention will be described in detail with reference to the drawings and specific embodiments, it is to be understood that these embodiments are merely illustrative of and not restrictive on the broad invention, and that various equivalent modifications can be effected therein by those skilled in the art upon reading the disclosure.
It will be understood that when an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present.
The radiofrequency ablation catheter device of the present embodiment will be explained and explained with reference to fig. 1 to 4. It should be noted that, in the embodiments of the present invention, like reference numerals denote like components. And for the sake of brevity, detailed descriptions of the same components are omitted in different embodiments, and the descriptions of the same components may be mutually referred to and cited.
In the description of the present specification, it is to be noted that the terms "proximal" and "distal" are used with respect to the body of a patient. The term "distal" refers to a direction relatively close to the body of a patient, while the term "proximal" refers to a direction relatively far from the body of a patient. The orientation or positional relationship indicated with the terms "upper", "lower", "left", "right", and the like is based on the orientation or positional relationship shown in fig. 1, and is merely for convenience of describing the present specification, and is not to be construed as a limitation of the embodiments of the present specification.
The present specification provides a radiofrequency ablation catheter device, primarily for modulating renal nerves located on renal arteries by removing or reducing the activity of the renal nerves in an injured or non-injured manner. However, if it is desired to modulate nerves at other locations (e.g., cardiac locations), one skilled in the art can make adjustments according to embodiments of the present disclosure that do not require creative efforts.
As shown in fig. 1 to 4, the radiofrequency ablation catheter device includes: a catheter body 1; an ablation assembly comprising: a plurality of ablation members 2, said ablation members 2 having opposite proximal 22 and distal 21 ends in their lengthwise extension, said proximal ends 22 being arranged inside said catheter body 1; the electrodes 3 are arranged on the distal end 21, a plurality of the electrodes 3 on the ablation component 2 are distributed at intervals along the axial direction of the catheter body 1, and in a section perpendicular to the axial direction of the catheter body 1, a plurality of the electrodes 3 are distributed at intervals along the circumferential direction of the surface along the projection of the section falling on the axial direction of the catheter body 1.
When the electrode 3 is close to the target area to be regulated, the electrode 3 plays a role of removing or reducing the activity of the renal nerve by releasing certain energy and acting on the nerve on the area. The electrode 3 may achieve this by transferring heat to this area. In particular, the electrode 3 needs to be electrically connected to a device that generates this energy (for example a radiofrequency device) or that allows the electrode 3 itself to generate this energy.
The catheter body 1 is used for driving the ablation assembly to move in a blood vessel. The ablation assembly is provided with a plurality of ablation members 2, wherein each ablation member 2 carries at least one electrode 3 thereon. The ablation member 2 may be of generally linear configuration having opposite proximal and distal ends 22, 21 along its longitudinal extent, the electrode 3 being disposed on the distal end 21, the proximal end 22 extending into the interior of the catheter body 1. Wherein a plurality of said electrodes 3 on the ablation member 2 are discretely spaced from each other in the axial direction of the catheter body 1, but when projected in the axial direction of the catheter body 1 onto any cross section perpendicular to the axial direction of the catheter body 1, the projections of all the electrodes 3 can be spaced around the circumference of the cross section. Further, the ablation zone generated by said electrodes 3 projected on the section can form a closed loop. In this way, on the one hand, the renal nerves can be effectively removed in the circumferential direction of the blood vessel, and on the other hand, no excessive ablation is caused on a certain section of the blood vessel.
In the present specification, the ablation assembly has an operating state in which the electrode 3 is extended out of the catheter body 1 and a housed state in which the electrode 3 is retracted, and when the ablation assembly is shifted from the housed state to the operating state, the distal end of the ablation member 2 moves away from the axis of the catheter body 1. Therefore, the electrode 3 can be tightly attached to the inner wall of the blood vessel to act on the nerves at the corresponding positions, the electrode 3 can conveniently move in the blood vessel, and the blood vessel wall 9 is not damaged.
When the ablation assembly is in the operative state, the distal end of the ablation member 2 is moved away from the axis of the catheter body 1 so that the electrode 3 can be brought close to or into contact with the vessel wall 9 and thus close to the renal nerve. Preferably, the number of the electrodes 3 is four, correspondingly, the number of the ablation members 2 is four, and each ablation member 2 is correspondingly provided with one electrode 3. However, the number of the electrodes 3 may be set to other numbers, for example, 6, 8, and the like, and the specific number of the electrodes is not limited in the present application. Correspondingly, the number of ablation members 2 should match the number of electrodes 3.
In this specification, as shown in fig. 2 to 2D, when the ablation unit is in the accommodated state, the electrode 3 at the distal end of the ablation member 2 can be brought into close contact with the outer circumferential wall surface 11 of the catheter body 1.
Specifically, the outer circumferential wall surface 11 of the catheter body 1 may be provided with a plurality of side holes 12 matched with the ablation member 2. Wherein the side aperture 12 is sized to allow the ablation member 2 to extend in and out, but to prevent the electrode 3 from passing from the side aperture 12 into the interior of the catheter body 1. Therefore, by adjusting the position and number of the side holes 12, the positions of the plurality of electrodes 3 attached to the blood vessel can be set.
The outer dimensions of the side aperture 12 may be smaller than the outer dimensions of the electrode 3 so as to prevent the electrode 3 from entering the catheter body 1 through the side aperture 12 when the ablation assembly is in the stowed state. Alternatively, in some possible embodiments, one of the side hole 12 and the electrode 3 is provided with a stop for limiting the passage of the electrode 3 from the side hole 12 to the inside of the catheter body 1.
In this specification, the catheter apparatus is configured to: when the ablation component 2 and the catheter body 1 are relatively moved along the axial direction of the catheter body 1, the ablation component 2 can slide along the side hole 12, and the ablation component can be switched between the working state and the containing state.
Specifically, when an axial force is applied to one of the proximal end 22 of the ablation member 2 and the catheter body 1, and the other is held stationary, the ablation member 2 can be caused to slide along the side aperture 12, such that the distal end 21 of the ablation member 2 expands in a direction toward the side aperture 12. In some possible embodiments, as shown in fig. 2C and 2D, when an axial force is applied to one of the proximal end 22 of the ablation member 2 and the catheter body 1 such that the ablation assembly moves relative to the catheter body 1 in the direction of the distal end 21, the distal end 21 of the ablation member 2 can be spread apart in a direction that slides toward the side hole 12 to bring the electrode 3 close to the vessel wall 9; as shown in fig. 2A and 2B, when an axial force is applied to one of the proximal end 22 of the ablation member 2 and the catheter body 1 such that the ablation assembly moves relative to the catheter body 1 in the direction of the proximal end 22, the distal end 21 of the ablation member 2 can be retracted in a direction to slide the side aperture 12 to move the electrode 3 away from the vessel wall 9.
In other possible embodiments, when the ablation assembly is moved relative to the catheter body 1 in the direction of the proximal end 22, the distal end 21 of the ablation member 2 can be spread apart in the direction of sliding towards the side hole 12, so as to bring the electrode 3 close to the vessel wall 9; when the ablation assembly is moved relative to the catheter body 1 in the direction of the distal end 21, the distal end 21 of the ablation member 2 can be retracted in a direction to slide towards the side aperture 12 to move the electrode 3 away from the vessel wall 9.
In the present description, the ablation member 2 is made of a material having elasticity, and the distal end 21 of the ablation member 2 has a supporting force, the supporting force of the distal end 21 being capable of promoting expansion of the distal end 21 in response to an axial force applied to the ablation member 2 or the catheter body 1. The ablation member 2 needs to be sufficiently crush-resistant and supportive to be able to respond to axial forces and transfer them to its distal end 21 in time and to support the electrode 3 against the vessel wall 9 in the operative state.
Preferably, the ablation member 2 is made of nickel alloy, and an insulating coating is disposed on the surface of the ablation member.
Further, as shown in fig. 2A and 2C, in the housed state, the ablation member 2 is configured in a curved configuration expanding away from the axis of the catheter body 1 toward the side hole 12 from the proximal end 22 to the distal end 21. This curvilinear configuration enables the distal end 21 of the ablation member 2 to expand in a curvilinear fashion as it slides along the side aperture 12 as the ablation member 2 or catheter body 1 responds to axial forces, and the electrodes 3 are disposed on the curvilinear configuration to provide a more stable adherence than a straight configuration.
In addition, the ablation member 2, whether it is a curved or straight configuration, is a linear configuration, and with the electrode 3 disposed at the distal end 21, as the ablation member 2 is slid along the side aperture 12 to expand outwardly, the sliding distance of the ablation member 2 relative to the side aperture 12 can be adjusted so that the adherence operation can be accomplished regardless of the diameter of the vessel. Therefore, when the large-diameter or small-diameter blood vessel needs to be adapted, the relative movement distance of the ablation member 2 and the catheter body 1 is controlled to achieve the purpose of adjustment.
Compared with the common support mode that the electrode 3 is fixed on the net-shaped structure or the basket-shaped structure, the catheter device provided by the embodiment of the specification has the advantages of simple structure and convenience in adjustment, can be quickly switched between the working state and the accommodating state by applying an axial force, can adjust the adherence range of the electrode under the working state, does not need to recover the deformation, and does not damage the blood vessel wall 9.
In some embodiments, the ablation assembly comprises: an inner tube 6 disposed inside the catheter body 1, the proximal ends 22 of the ablation members 2 each being connected to the inner tube 6; the ablation assembly is in a stored state when the inner tube 6 is moved relative to the catheter body 1 in a direction towards the proximal end 22 of the ablation member 2, and the ablation assembly is in an active state when the inner tube 6 is moved relative to the catheter body 1 in a direction towards the distal end 21 of the ablation member 2.
The proximal end 22 of the ablation member 2 may be bonded to the head end of the inner tube 6. As such, when the inner tube 6 is pushed towards the distal end of the catheter body 1 or the catheter body 1 is pushed towards the proximal end of the ablation member 2, the ablation member 2 can be caused to slide in the direction of the side hole 12.
In this embodiment, the catheter body 1 may be a hollow structure in which the ablation member 2 and the inner tube 6 may be disposed. The ablation member 2 may be of an electrically conductive material, and the electrodes 3 are electrically connected to an external radiofrequency device through the ablation member 2. When the proximal ends 22 of the plurality of ablation members 2 are connected to the inner tube 6, the ablation members 2 may be electrically connected to an external radio frequency device via wires embedded in the inner tube 6.
Alternatively, the ablation member 2 has a lumen, and the catheter device comprises: the ablation lead is arranged in the cavity, and the electrode 3 is electrically connected with external radio frequency equipment through the ablation lead. The ablation wire may extend from the lumen of the ablation member 2 into the inner tube 6 until connected to an external radio frequency device.
In some embodiments, the ablation member 2 is made of an electrically conductive material, the electrode 3 is electrically connected with an external radio frequency device through the ablation member 2, the ablation members 2 are connected with each other to form an electrically conductive wire bundle, the ablation assembly is in a receiving state when the electrically conductive wire bundle moves towards the proximal end 22 of the ablation member 2 relative to the catheter body 1, and the ablation assembly is in an operating state when the electrically conductive wire bundle moves towards the distal end 21 of the ablation member 2 relative to the catheter body 1.
In the present embodiment, a plurality of ablation members 2 are directly connected in parallel to form a conductive wire bundle, the catheter body 1 may be a hollow structure, and the ablation members 2 and the conductive wire bundle may be disposed in the hollow structure. The bundle of conductive wires may be pushed directly under the action of axial force and the ablation member 2 may directly electrically connect the electrode 3 with an external radiofrequency device.
In some embodiments, as shown in fig. 3, the catheter apparatus may comprise: a sheath 5 externally fitted to the catheter body 1, the catheter device being configured to: when the sheath 5 slides along the catheter body 1 and is sleeved on the ablation member 2, the ablation assembly is in a storage state, and when the sheath 5 slides away from the ablation member 2, the ablation assembly is in a working state.
When the ablation assembly is in a working state, the ablation member 2 is in a natural state without being subjected to external force, the ablation member 2 can be made of a shape memory material, the ablation member 2 is kept in an expanded state without being subjected to external force, and at the moment, all the electrodes 3 on the ablation member 2 extend out of the catheter body 1. When external force is applied to the ablation member 2, the ablation member 2 can be deformed so as to facilitate the ablation assembly to be restored to the accommodated state in response to the external force, and the electrode 3 is made to be closely attached to the outer peripheral wall surface 11 of the catheter body 1.
In the present embodiment, the sheath 5 is slightly harder than the material of the ablation member 2. The ablation member 2 is itself shaped to the operative state of the ablation assembly when not subjected to external forces. When the user manipulates the sheath 5 over the ablation member 2 and off the ablation member 2, the ablation member 2 can be caused to transition between changing its shape and recovering its shape.
When the sheath 5 is sleeved on the ablation member 2, the ablation member 2 changes its shape due to the material hardness of the sheath 5 being greater than that of the ablation member 2, and is accommodated in the sheath 5, and the electrode 3 is tightly attached to the outer peripheral wall surface 11 of the catheter body 1; when the sheath 5 is detached from the ablation member 2, the ablation assembly is returned to the working state because the ablation member 2 can restore its shape.
Of course, in some possible embodiments, the catheter body is a sheath, and the ablation member may be fully retracted into the catheter body when the ablation assembly is moved toward the proximal end of the catheter body, and extended out of the catheter body when the ablation assembly is moved toward the distal end of the catheter body. In this embodiment, the relative position of the catheter body and ablation assembly needs to be readjusted.
In this specification, as shown in fig. 4, when the ablation assembly is in the accommodated state, the electrode 3 on the distal end 21 of the ablation member 2 may be accommodated in the catheter body 1.
Specifically, a guide mechanism for forming a channel is arranged in the catheter body 1; when the ablation assembly is in a containing state, the ablation component 2 is completely contained in the channel, and when the ablation assembly is in a working state, the channel can guide the ablation component 2 in the channel towards the side hole 12.
Unlike the above-described embodiment, the outer dimension of the electrode 3 needs to be smaller than the outer dimension of the side hole 12, and in the accommodated state, the electrode 3 can be accommodated in the guide mechanism from the side hole 12, thereby facilitating passage of the catheter device through the blood vessel. When adherence of the electrode 3 is required, the proximal end 22 of the ablation member 2 or the catheter body 1 is under axial force, and the ablation member 2 can be guided out of the side hole 12 through the guide mechanism and moved away from the axis of the catheter body 1.
As shown in fig. 4A, in the present embodiment, the catheter body 1 may have a solid configuration, the guiding mechanism being a channel opening toward the inside of the catheter body 1 along the position of the side hole 12, the ablation member 2 being disposed within the channel. Specifically, when the number of the electrodes 4 is four, the number of the ablation members 2 is four, and the guiding mechanism is a first channel 4a, a second channel 4b, a third channel 4c and a fourth channel 4d which are opened from the position of the side hole 12 toward the inside of the catheter body 1.
Further, as shown in fig. 4B, the catheter body 1 is provided with a cavity at its proximal end. When the ablation member 2 is connected to the inner tube 6, the inner tube 6 may be arranged in the cavity. Alternatively, when the ablation member 2 is constituted by an electrically conductive wire bundle, the proximal end of the electrically conductive wire bundle may be arranged in the cavity. The cavity communicates with the guide means to guide part of the ablation member 2 into the cavity.
Alternatively, in some embodiments, by applying an axial force to the catheter body 1 to slide the ablation member 2 along the side aperture 12, the catheter body 1 may not need to be provided with a cavity at its proximal end, and the ablation member 2 may be guided in motion only through the first, second, third and fourth channels 4a, 4b, 4c, 4 d.
In this description, the end of the catheter body 1 is provided with a compliant structure 7 for facilitating delivery of the catheter body 1 in the target vascular anatomy when in the stowed state. The compliant structure 7 is of a flexible material so that it does not easily push against the vessel as the catheter device is passed over the bend.
In this specification, the catheter apparatus includes: the catheter comprises a handle 8 matched and connected with the catheter body 1, wherein the handle 8 is provided with an operation part 81, and the handle 8 can control the relative movement of the ablation member 2 and the catheter body 1 in the axial direction of the catheter body 1 through the operation part 81 so as to realize the conversion between the working state and the accommodating state of the ablation member 2.
Specifically, the handle 8 may be provided with an operation portion 81 for controlling the forward and backward movement of the catheter body 1, or for controlling the forward and backward movement of the inner tube 6 or the conductive wire harness. The operation part 81 is coupled to the proximal end of the catheter body 1 when it is used to control the forward and backward movement of the catheter body 1, and is coupled to the proximal end of the inner tube 6 or the conductive wire harness when the operation part 81 is used to control the forward and backward movement of the inner tube 6. The operation portion 81 may be in the form of a dial, a paddle, a knob, or a slide portion, and the present application is not particularly limited.
The control of the operation unit 81 may be performed by a human being, or may be performed automatically by designing a special gripping mechanism to be used in cooperation with a surgical robot in a possible scenario. The handle 8 is also connected with a radio frequency ablation power supply which can provide the required radio frequency energy for the electrode 3.
For a better understanding of the present application, the following further describes the use of the rf ablation catheter device provided in the embodiments of the present specification:
after the catheter device is pushed to a target blood vessel, the relative movement of the catheter body 1 or the inner tube 6 is controlled by the operating part 81 on the handle 8, so that the ablation members 2 slide relative to the side holes 12, the ablation members 2 extend the electrodes 3 at the distal ends 21 out of the catheter body 1 until the electrodes 3 are attached to the blood vessel wall 9, and the operation of adhering the electrodes 3 to the wall can be completed, and at the moment, the ablation members 2 are in a spread state.
The ablation member 2 is made of nickel alloy and the like, so that the electrode 3 has certain folding resistance and support performance and can be supported and attached to the vessel wall 9. The position of the side hole 12 on the catheter body 1 is designed in advance, and the adherence positions of the electrodes 3 are distributed at intervals along the axial direction of the blood vessel and are distributed at equal included angles of 360 degrees along the circumferential direction of the blood vessel. Because the sliding distance of the ablation member 2 relative to the side hole 12 on the catheter body 1 can be adjusted, the adherence operation can be completed by large blood vessels or small blood vessels.
After the electrode adherence is completed, the radiofrequency ablation power supply can be controlled to generate radiofrequency electric energy pulses to ablate the target renal nerve tissue. And after the preset ablation time is reached, stopping releasing energy, and finishing the ablation of the current point location. Relative movement of the catheter body 1 or inner tube 6 is then controlled by the operating portion 81 on the handle 8, causing the respective ablation members 2 to slide in opposite directions relative to the side holes 12 until all of the electrodes 3 are simultaneously returned to the outer wall of the catheter body 1, at which time the ablation members 2 return to their original collapsed condition.
The handle 8 is held and the position of the catheter device is continuously adjusted until the next target vessel or ablation area for the next renal sympathetic nerve ablation. And circulating the above operations to complete the ablation of a plurality of regions and a plurality of blood vessels, including the renal aorta and the branch blood vessels thereof, and then completing all the ablation operations, namely completing the renal artery ablation operation.
The above embodiments are merely illustrative of the technical concepts and features of the present application, and the purpose of the present invention is to enable those skilled in the art to understand the content of the present application and implement the present application, and not to limit the protection scope of the present application. All equivalent changes and modifications made according to the spirit of the present application should be covered in the protection scope of the present application.
A plurality of elements, components, parts or steps can be provided by a single integrated element, component, part or step. Alternatively, a single integrated element, component, part or step may be divided into separate plural elements, components, parts or steps. The disclosure of "a" or "an" to describe an element, ingredient, component or step is not intended to foreclose other elements, ingredients, components or steps.
It is to be understood that the above description is intended to be illustrative, and not restrictive. Many embodiments and many applications other than the examples provided will be apparent to those of skill in the art upon reading the above description. The disclosures of all articles and references, including patent applications and publications, are hereby incorporated by reference for all purposes.

Claims (15)

1. A radio frequency ablation catheter device, comprising:
the catheter comprises a catheter body, wherein a plurality of side holes are formed in the peripheral wall surface of the catheter body;
an ablation assembly comprising: a plurality of ablation members having opposite proximal and distal ends in a lengthwise extension thereof, the proximal ends being disposed inside the catheter body; an electrode disposed on the distal end, a plurality of electrodes on the ablation member being spaced apart along an axial direction of the catheter body, a plurality of projections of the electrodes on the cross section along the axial direction of the catheter body being spaced apart along a circumferential direction of the plane in a cross section perpendicular to the axial direction of the catheter body;
the catheter apparatus is configured to: when the ablation component and the catheter body move relatively along the axial direction of the catheter body, the ablation component can slide along the side hole, and the ablation component can be switched between a working state that the electrode extends out of the catheter body and a containing state that the electrode is retracted.
2. The rf ablation catheter device of claim 1, wherein the electrode on the distal end of the ablation member abuts the outer peripheral wall surface of the catheter body when the ablation assembly is in the stowed position.
3. The rf ablation catheter device of claim 2, wherein one of the side aperture and the electrode is provided with a stop for limiting passage of the electrode from the side aperture into the interior of the catheter body.
4. The radio frequency ablation catheter device of claim 2, wherein an outer dimension of the electrode is greater than an outer dimension of the side hole.
5. The rf ablation catheter device of claim 1 wherein the electrode on the distal end of the ablation member is receivable within the catheter body when the ablation assembly is in the received state.
6. The rf ablation catheter device of claim 5, wherein a guide mechanism is disposed within the catheter body for forming a channel, the ablation element is fully received within the channel when the ablation assembly is in the receiving state, and the channel guides the ablation element therein toward the side aperture when the ablation assembly is in the operating state.
7. The radio frequency ablation catheter device of claim 6 wherein the catheter body has a solid construction, the channel being formed by a slot opening toward the interior of the catheter body at a location along the side aperture, the ablation member being disposed within the channel.
8. The radio frequency ablation catheter device of claim 5, wherein an outer dimension of the electrode is smaller than an outer dimension of the side hole.
9. The rf ablation catheter device of claim 1 wherein the ablation member is made of a material having a resiliency, the distal end of the ablation member having a supporting force that facilitates expansion of the distal end in response to an axial force applied to the ablation member or the catheter body.
10. The radio frequency ablation catheter device of claim 1, wherein in the stowed state, the ablation member is configured in a curvilinear configuration expanding away from the axis of the catheter body toward the side aperture from the proximal end to the distal end.
11. The radio frequency ablation catheter device of claim 1 wherein the ablation assembly comprises: an inner tube disposed inside the catheter body, the proximal ends of the ablation members each being connected to the inner tube;
when the inner tube moves relative to the catheter body towards the proximal direction of the ablation member, the ablation assembly is in a storage state, and when the inner tube moves relative to the catheter body towards the distal direction of the ablation member, the ablation assembly is in an operating state.
12. The rf ablation catheter device of claim 1 wherein the ablation member is an electrically conductive material and the electrode is electrically connected to an external rf device through the ablation member.
13. The radiofrequency ablation catheter device of claim 1 wherein the ablation member has a lumen, the catheter device comprising: the ablation lead is arranged in the cavity, and the electrode is electrically connected with external radio frequency equipment through the ablation lead.
14. The rf ablation catheter device of claim 1 wherein the ablation member is an electrically conductive material, the electrode is electrically connected to an external rf device through the ablation member, the plurality of ablation members are interconnected to form a conductive wire bundle, the ablation assembly is in the stowed state when the conductive wire bundle is moved relative to the catheter body in a proximal direction of the ablation member, and the ablation assembly is in the operative state when the conductive wire bundle is moved relative to the catheter body in a distal direction of the ablation member.
15. The rf ablation catheter device of claim 1, wherein the catheter device comprises: the handle is provided with an operating part, and the handle can control the relative movement of the ablation component and the catheter body in the axial direction of the catheter body through the operating part.
CN202111394995.0A 2021-11-23 2021-11-23 Radio frequency ablation catheter device Pending CN113995503A (en)

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