CN114668483A - Ablation device and ablation catheter thereof - Google Patents
Ablation device and ablation catheter thereof Download PDFInfo
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- CN114668483A CN114668483A CN202210113399.9A CN202210113399A CN114668483A CN 114668483 A CN114668483 A CN 114668483A CN 202210113399 A CN202210113399 A CN 202210113399A CN 114668483 A CN114668483 A CN 114668483A
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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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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- 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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- 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
- A61B2018/00595—Cauterization
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- A—HUMAN NECESSITIES
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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
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
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Abstract
The application discloses ablation device and ablation catheter thereof should melt the catheter and include: a tubular member, the tubular member being flexible and having an operative end and a working end; a main control shaft slidably disposed within the tubular member; the ablation subassembly, this ablation subassembly is flexible and set up in the tubular member slidably, and the ablation subassembly has the ablation element carrier part of being made by shape memory material, and a plurality of ablation elements are carried to this ablation element carrier part, and the ablation subassembly can contract in the tubular member in order to keep linear extension state and can stretch out and make ablation element carrier part present radial expansion part from the working end of tubular member under the drive of main control shaft, and the ablation catheter includes: at least one auxiliary control shaft, this auxiliary control shaft slidable ground sets up in tubular member, and this auxiliary control shaft fixed connection is in ablation component bearing part of melting subassembly to slide along main control shaft under this auxiliary control shaft's drive.
Description
The application is a divisional application of Chinese patent application with the application number of 202111224530.0, the application date of 21/10/2021, the application number of 202111070759.3 for Chinese priority and the priority date of 13/9/2021.
Technical Field
The present application relates to the field of ablation, and more particularly, to an ablation catheter for ablation treatment of a tissue object to be treated and an ablation device including the ablation catheter.
Background
Ablation is the placement of a catheter into the tissue object to be treated and then the application of energy to the tissue using the electrodes of the catheter to selectively cause cell death in a portion of the region. Ablation has a wide range of indications, such as solid tumors, atrial fibrillation, etc.
In the treatment of atrial fibrillation with ablation, the catheter tip is delivered to the target site of the heart by vascular puncture, followed by spark ablation. The treatment aim is realized by correcting abnormal conduction paths of cardiac electrical signals.
An ablation device is a device that performs an ablation procedure and generally includes an electrode having an ablation catheter disposed therein, a steering handle connected to the ablation catheter for steering the electrode, and a controller electrically connected to the electrode for controlling electrical impulses. In operation, after the electrodes incorporated in the ablation catheter extend from the catheter and are placed against the tissue site to be treated, the task of detecting bioelectrical parameters is typically performed, followed by the task of applying energy to the target site, between which the position of the electrodes often needs to be adjusted for optimal treatment. However, at present, although numerous structural forms of ablation catheters have been proposed in the art, most conventional ablation catheters cannot conveniently and flexibly adjust the mutual position between the electrodes; even with the adjustment function, the adjustment range is not controlled and precise adjustment cannot be realized.
Therefore, how to obtain a solution of an ablation device with a high degree of freedom in operation with respect to the relative position of the tissue site to be treated is a technical problem to be solved in the art.
Disclosure of Invention
In view of the above, the present application provides an ablation device and an ablation catheter thereof, which can achieve a high degree of freedom in relative position to a tissue site to be treated during operation.
According to one aspect of the present application, there is provided an ablation catheter comprising: a tubular member, the tubular member being flexible and having an operative end and a working end; a main control shaft slidably disposed within the tubular member; the ablation assembly is flexible and can be arranged in the tubular member in a sliding mode, the ablation assembly is provided with an ablation element bearing part made of shape memory materials, the ablation element bearing part is provided with a plurality of ablation elements which are arranged at intervals, and the ablation assembly can be contracted in the tubular member under the driving of the main control shaft to keep a linear extending state and can extend out of the working end of the tubular member to enable the ablation element bearing part to be provided with at least one radial expansion part; the ablation catheter includes: at least one auxiliary control shaft, the auxiliary control shaft can be arranged in the tubular part in a sliding mode, and the auxiliary control shaft is fixedly connected to the ablation element bearing part of the ablation assembly and driven by the auxiliary control shaft to slide along the main control shaft.
Preferably, in a condition in which the ablation assembly is extended from the working end of the tubular member, the secondary control shaft is capable of adjusting the degree of radial expansion of the at least one radially expandable portion by sliding the ablation element carrier relative to the primary control shaft.
Preferably, the radially expanded portion has a spiral shape; and/or when viewed from the axial direction of the main control shaft, the radial expansion part is a circle taking the main control shaft as the center of a circle.
Preferably, the tail end of the main control shaft is fixedly connected to the tail end of the ablation element bearing part, a sliding part is fixedly arranged on the ablation element bearing part, and the sliding part is slidably arranged on the main control shaft and is fixedly connected with the auxiliary control shaft.
Preferably, in a state in which the ablation assembly is extended from the working end of the tubular member, the ablation element carrying section is divided into a first expanded section and a second expanded section by the slider.
Preferably, the distal end of the ablation element carrying part is slidably arranged at the distal end region of the main control shaft, the auxiliary control shaft is fixedly connected to the distal end of the ablation element carrying part, and the ablation element carrying part is fixedly connected to the main control shaft through a fixing part.
Preferably, in a state in which the ablation assembly is extended from the working end of the tubular member, the ablation element carrying section is divided into a first expanded section and a second expanded section by the fixing member.
Preferably, the sliding fit is achieved by a sliding structure such as a sliding slot or shaft hole.
Preferably, the sliding fit has a predetermined sliding range.
Preferably, in a state in which the ablation assembly projects from the working end of the tubular member, a first expansion portion, which is further from the working end of the tubular member in the axial direction, expands in the radial direction to a lesser extent than a second expansion portion.
Preferably, the ablation element is operable to detect an electrical signal of tissue to be treated; and/or for providing at least one of acoustic, electrical and/or magnetic energy, thermal energy, chemical energy, radiation energy.
Preferably, the ablation element is an electrode.
Preferably, said plurality of electrodes distributed over at least one radially expanded portion are adapted to form a circumferential and/or axial electric field in a state in which said ablation assembly is extended from said working end of said tubular member.
According to another aspect of the present application, there is provided an ablation catheter comprising: a tubular member, the tubular member being flexible and having an operative end and a working end; a plurality of control shafts which are respectively parallel and independent to each other and are slidably arranged in the tubular member; the ablation device comprises a plurality of ablation assemblies, each ablation assembly is flexible and is provided with an ablation element bearing part made of a shape memory material, the ablation element bearing part is used for bearing a plurality of ablation elements which are arranged at intervals, each ablation assembly is connected with a respective control shaft and can be contracted in the tubular part under the driving of the control shaft so as to keep a linear extending state and can extend out of the working end of the tubular part, so that the ablation element bearing part is provided with a radial expansion part.
Preferably, the extent to which different ablation assemblies extend in the axial direction is different in the state in which the ablation assemblies extend from the working end of the tubular member.
Preferably, the radially expandable portions of different ablation assemblies are expanded to different extents in the radial direction in a condition in which the ablation assemblies extend from the working end of the tubular member.
Preferably, in the condition in which the ablation assembly projects from the working end of the tubular member, the radially expandable portion of the ablation assembly projecting further in the axial direction expands to a lesser extent in the radial direction.
Preferably, the ablation catheter includes a sliding guide provided to the plurality of control shafts for guiding the plurality of control shafts to slide in sliding directions parallel to each other.
Preferably, each control shaft is slidably provided to the slide guide; or at least one of the control shafts is fixed to the sliding guide and is slidably disposed on the sliding guide.
Preferably, the sliding fit is achieved by a sliding structure such as a sliding slot or shaft hole. Preferably, the sliding fit has a predetermined sliding range.
Preferably, the radially expanded portion has a helical shape; and/or the radially expanding portion is circular as viewed in the axial direction of the control shaft.
Preferably, the distal ends of the respective ablation element carriers are fixedly connected to each other.
Preferably, the ablation catheter comprises a telescoping control shaft slidably disposed within the tubular member, the telescoping control shaft being fixedly attached to the distal end of each ablation element carrier.
Preferably, the distal ends of the respective ablation element carriers are slidably connected to one another within a predetermined sliding range.
Preferably, the ablation catheter includes a telescoping control shaft slidably disposed within the tubular member and fixedly attached to the distal end of the ablation element carrier portion that extends outwardly from the tubular member to a maximum extent.
Preferably, the ablation assembly comprises a first ablation assembly with a first ablation element bearing portion and a second ablation assembly with a second ablation element bearing portion, in a state that the ablation assembly extends out of the working end of the tubular member, the first ablation element bearing portion extends out of the tubular member to a far extent from the second ablation element bearing portion, an end portion of the first ablation element bearing portion is in sliding fit with an end portion of the second ablation element bearing portion within a preset sliding range, and the telescopic control shaft is fixedly connected to the end portion of the first ablation element bearing portion.
Preferably, the ablation element is operable to detect an electrical signal of tissue to be treated; and/or for providing at least one of acoustic, electrical and/or magnetic energy, thermal energy, chemical energy, radiation energy.
Preferably, the ablation element is an electrode.
Preferably, the plurality of electrodes distributed over the radially expanded portion of each ablation assembly are adapted to form a circumferential and/or axial electric field in a condition in which the ablation assembly extends from the working end of the tubular member.
According to still another aspect of the application, an ablation device is also provided, which comprises an ablation catheter, a control handle connected with the ablation catheter and a controller electrically connected with the ablation catheter, wherein the ablation catheter is the ablation catheter provided by the application.
According to the technical scheme of the application, through setting up at least one and assisting the control shaft, should assist the control shaft fixed connection in the ablation subassembly ablation element bearing part, can utilize this to assist the control shaft and drive ablation element bearing part and follow main control shaft slides to in the state that the ablation subassembly is followed the working end of tubular member stretches out, assist the control shaft can be through making ablation element bearing part for main control shaft slides and adjust at least one radial expansion degree of radial expansion part, and then the realization has higher degree of freedom for the relative position at pending tissue position.
Additional features and advantages of the present application will be described in detail in the detailed description which follows.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate an embodiment of the invention and, together with the description, serve to explain the invention. In the drawings:
fig. 1-3 are schematic structural reference views of an ablation catheter in accordance with a preferred embodiment of the present application;
fig. 4-7 are schematic structural reference views of an ablation catheter according to various other embodiments of the present application.
Detailed Description
Ablation can be used for a variety of medical applications, such as ablation of cancerous tissue, ablation of nerve tissue, ablation of atrial fibrillation, and so forth. For the sake of simplicity, the present application mainly describes the technical solution of the present application by taking an application scenario of treating atrial fibrillation as an example, but it should be noted that the technical solution of the present application is not limited to the ablation application scenario of treating atrial fibrillation, but also covers other suitable application scenarios.
The basic procedure for ablation for the treatment of atrial fibrillation is: under the guidance of medical images, the ablation catheter is guided to a preset position in the heart (such as the connection position of a pulmonary vein and the heart), an electrode in the ablation catheter is stretched out and contacts a target position (such as myocardial cells and/or blood vessel inner wall cells), and then high-frequency current is released by the electrode, so that the cells are necrotized in a small specific range, and an electric signal conducting circuit is improved, so that the treatment purpose is achieved.
Most conventional ablation catheters are not capable of easily and flexibly adjusting the relative position between the electrodes, which may result in undesirable treatment effects. In order to enable the ablation catheter to have higher degree of freedom relative to the position of a tissue part to be treated when in work, the application provides an ablation device which comprises the ablation catheter, a control handle connected with the ablation catheter and a controller electrically connected with the ablation catheter. An operator can control the position and the posture of the ablation catheter entering the human body, whether the electrode is unfolded or not and the like through the control handle; the operating state of the electrodes (ablation elements) can be controlled by a controller.
In the present application, mainly the improved technical solution proposed for the ablation catheter, therefore, the structure of the ablation catheter and the working process thereof will be described with emphasis; while other components (e.g., steering handles, controls, etc.) are simplified and one skilled in the art can refer to the corresponding components of the presently available ablation devices.
Hereinafter, the technical solutions of the present application will be described in detail with reference to the accompanying drawings of the specification to the extent that they are fully disclosed. It is to be understood that the technical contents described in the specification and the drawings thereof are only for exemplary explanation of the technical solution of the present application and do not limit the scope of the technical solution claimed in the present application.
1. Implementation mode one
Fig. 1-3 depict an ablation catheter according to a preferred embodiment of the present application. Fig. 1 to 3 can be subdivided into three different embodiments, which are the first embodiment, if they are distinguished in greater detail.
As shown in the embodiments of the present application illustrated in fig. 1-3, an ablation catheter may include a tubular member 10, a primary control shaft 11, and an ablation assembly a.
The tubular member 10 has an operative end (for connection to the steering handle and controls, not shown) and a working end 101. The working end 101 enters a predetermined position of the human body and performs subsequent operation processing. The tubular member 10 is of a thin tubular shape and is flexible to allow meandering according to different paths within the human body; the tubular member 10 typically has an internal diameter in the range of about 1 to 5mm, preferably 1.32 to 3.96 mm; can be made of the following materials: polyethylene (PE), polyether block Polyamide (PEBAX), Nylon (Nylon), thermoplastic polyurethane elastomer (TPU), polyvinyl chloride (PVC), and the like. The size and material of the tubular member may be designed according to different application conditions, and are not limited to the above-described illustrative examples.
A main control shaft 11 is slidably arranged in the tubular member 10, and the slidable design of the main control shaft 11 in the tubular member 10 allows a control handle to be used for controlling the ablation assembly a to extend from the inside of the tubular member 10 to the working end 101 through the main control shaft 11 for ablation operation, and to be operated to retract the ablation assembly a into the tubular member 10 after the operation is completed, and then leave the human body together with the tubular member 10.
Generally, the main control shaft 11 is flexible like the tubular member 10, and may be made of Polyethylene (PE), polyether block Polyamide (PEBAX), Nylon (Nylon), thermoplastic polyurethane elastomer (TPU), polyvinyl chloride (PVC), or the like. The main control shaft has a radial dimension smaller than the internal diameter of the tubular member 10 so as to be housed inside the tubular member 10 and able to move inside the tubular member 10.
The ablation assembly a is flexible and slidably disposed in the tubular member 10. The ablation assembly is retractable within the tubular member 10 to maintain the linear extension thereof and is extendable from the working end 101 of the tubular member 10 by the actuation of the primary control shaft 11 such that the ablation element carrier 12 exhibits at least one radially expanded portion 121, 122, as shown in the various figures, which is a schematic view of the ablation element carrier 12 in a radially expanded state.
The ablation assembly a has an ablation element carrier 12 made of a shape memory material including, but not limited to, nitinol or a shape memory polymer. Thus, when the ablation assembly is extended from the working end 101 of the tubular member 10 by manipulation of the main control shaft 11 by the manipulation handle, the ablation element carrier 12 will automatically again assume the memorized shape (the expanded state described above). The memorized shape can be selected from different spatial shapes according to different working conditions, so that the expansion form shown in the drawing of the application specification is only an exemplary illustration, and other expansion forms in various forms fall into the protection scope of the application.
The ablation element carrier 12 carries a plurality of ablation elements S arranged at a distance from one another. The ablation element S is electrically or communicatively connected to an external controller to release energy to a target site under control signals from the controller. The ablation element is operable to detect an electrical signal of tissue to be treated; and/or for providing at least one of acoustic, electrical and/or magnetic energy, thermal, chemical, radiation energy at the time of treatment. But preferably the ablation element is an electrode for delivering electrical energy.
As described above, in the conventional ablation apparatus, if the ablation element bearing portion is released from the tubular member and deployed into the expanded state, fine adjustment, especially fine adjustment, of the position and shape of the ablation element bearing portion is generally impossible, and thus fine adjustment of the position of the ablation element carried on the ablation element bearing portion, the relative position between the ablation elements, and the relative position between the ablation element and the target point is impossible. However, in the actual operation of ablation, it is almost impossible to achieve that the ablation element carrier part, after being extended and deployed from the tubular member, will then reach the very desired target site with high precision, always with a slight positional deviation from the target site. Thus, the ablation catheter solutions of conventional ablation devices fail to address these issues. On the one hand, very high operating requirements are placed on the operator and, on the other hand, the intraoperative risks are inevitably increased if the tubular member and its ablation element carrier are re-manipulated. Moreover, if the deviation is too large, the ablation treatment will not achieve good therapeutic effect, but will even cause additional damage to the patient.
In order to solve the above problem, in the technical solution of the present application, the ablation catheter includes at least one secondary control shaft 13. The auxiliary control shaft 13 is slidably disposed in the tubular member 10, and the auxiliary control shaft 13 is fixedly connected to the ablation element carrying portion 12 of the ablation assembly so as to slide along the main control shaft 11 under the driving of the auxiliary control shaft 13. Thus, with the secondary control shaft 13, the magnitude of the expansion of the radially expandable section and the relative position of the ablation element S can be flexibly controlled after the ablation assembly is extended from the working end 101 of the tubular member 10.
According to the ablation catheter, after the ablation assembly is driven by the main control shaft 11 to extend out of the working end 101 of the tubular member 10, the posture change of the ablation element bearing part 12 can be controlled through the auxiliary control shaft 13. In particular, in the condition in which the ablation assembly is extended from the working end 101 of the tubular member 10, the secondary control shaft 13 is able to adjust the degree of radial expansion of at least one of the radially expandable portions 121,122, respectively, by sliding the ablation element carrier 12 relative to the primary control shaft 11. For example, by moving the secondary control shaft 13 towards the radially expandable portion 121, the radially expandable portion 121 tends to be annular in shape under the action of the shape memory of its material, while the radially expandable portion 122 is stretched; when the secondary control shaft 13 is moved toward the radially expanding portion 122, the radially expanding portion 122 tends to be annular in shape by the shape memory of the material thereof, and the radially expanding portion 122 is stretched. According to the embodiment, flexible control of the working attitude of the melting element carrying section 12 is achieved by the auxiliary control shaft 13.
The shape memory of ablation element carrier 12 in its natural state, which may be made of a shape memory material, may take a variety of forms. Wherein the radially expandable portion may be in a spiral shape or an annular or other suitable shape in a natural state; and/or the radial expansion part is circular, circular arc or elliptical with the main control shaft as the center of a circle when viewed from the axial direction of the main control shaft 11. On the other hand, the main control shaft 11 may be located near the center or the edge of the radially expanded portion. For example, as shown in fig. 1, the radially expandable portions 121,122 are disposed around the main control shaft 11, or as shown in fig. 2, the main control shaft 11 is disposed near the extended tracks of the radially expandable portions 121,122, and ablation catheters with different structures can be adopted according to different application scenarios.
The auxiliary control shaft 13 can control the movement of the melting element carrying part 12 in various ways. The following description is made separately.
As shown in fig. 1 and 2, distal end E1 of primary control shaft 11 of the ablation catheter is fixedly connected to distal end E2 of ablation element carrier 12 to maintain the relative position between distal end E1 of primary control shaft 11 and distal end E2 of ablation element carrier 12 fixed in the event secondary control shaft 13 is moved, and to prevent ablation element carrier 12 from rotating relative to primary control shaft 11. The secondary control shaft 13 may be directly connected to the ablation element carrier 12 between said radially expanded portions 121,122, or preferably a slider 123 is fixedly arranged on the ablation element carrier 12, which slider 123 is slidably arranged on the primary control shaft 11 and fixedly connected to the secondary control shaft 13 for guiding the slider 123 and the secondary control shaft 13. In the embodiment provided with the sliding member 123, the auxiliary control shaft 13 is fixedly connected to the sliding member 123, and the sliding member is fixedly connected to the ablation element bearing portion 12 and slidably disposed on the main control shaft 11, so that after the ablation element bearing portion 12 is expanded by being pushed by the main control shaft 11, the main control shaft 11 is temporarily stationary, and at this time, the sliding member 123 can be driven to slide along the main control shaft 11 by the pushing and pulling action of the auxiliary control shaft 13, so as to drive the change of the expanded shape of the ablation element bearing portion 12.
In the state where the ablation assembly is extended from the working end 101 of the tubular member 10, the ablation element carrier 12 is divided by the slider 123 into a first expanded portion 121 and a second expanded portion 122, but the present application is not limited thereto. Specifically, as shown in fig. 1 and 2, when the secondary control shaft 13 pushes the slider 123 outward to move, the degree of radial expansion of the first expansion portion 121 becomes large, and the degree of expansion of the second expansion portion 122 becomes small; and when the secondary control shaft 13 is moved by pulling the slider 123 inward, the degree of radial expansion of the first expansion portion 121 becomes smaller, and the degree of expansion of the second expansion portion 122 becomes larger. Of course, the main control shaft 11 may also move in cooperation with the auxiliary control shaft.
As shown in fig. 3, in accordance with another embodiment of the ablation catheter, distal end E2 of ablation element carrier 12 may also be slidably disposed at the distal end E1 region of primary control shaft 11. In this regard, the secondary control shaft 13 is fixedly attached to the distal end E2 of the ablation element carrying section 12, and the ablation element carrying section 12 is preferably fixedly attached to the primary control shaft 11 by fasteners 124 (the fasteners 124 are also omitted). In the state in which the ablation assembly is extended from the working end 101 of the tubular member 10, the ablation element carrier 12 is divided by the fixing member 124 into a first expanded portion 121 and a second expanded portion 122. When the main control shaft 11 is fixed, the movement of the end E2 relative to the main control shaft 11 can be controlled by moving the sub control shaft 13, thereby adjusting the degree of expansion of the first expansion part 121; in the case of moving the main control shaft 11 and the auxiliary control shaft 13 at the same time, the degree of expansion of the second expansion part 122 can be adjusted, so that the respective control of the degrees of expansion of the first expansion part 121 and the second expansion part 122 can be realized, and the relative position between the ablation elements S on the first expansion part 121 and the ablation elements S on the second expansion part 122 can be flexibly adjusted.
The sliding engagement between the slider 123 or the end E2 and the main control shaft 11 as in the above two embodiments may be achieved by a sliding structure such as a sliding groove or a shaft hole. Preferably, the sliding fit has a predetermined sliding range, which can be achieved by a stop structure (such as a bump or step or circumferential flange, etc.) provided on the main control shaft 11 on the sliding path of the slider 123 or the end E2. The sliding range through limiting the sliding fit can realize more accurate adjustment on the basis of allowing position adjustment, and the adjustment precision is improved.
Preferably, as shown in fig. 1 to 3, in a state in which the ablation assembly is extended from the working end 101 of the tubular member 10, the first expansion portion 121, which is further from the working end 101 of the tubular member 10 in the axial direction, is expanded in the radial direction to a lesser extent than the second expansion portion 122. Thus, during an ablation procedure, the first expandable section 121 is more suitable for extending deep into the interior of the blood vessel, while the second expandable section 122 is more suitable at and adjacent to the interface of the blood vessel and the heart.
2. Second embodiment
As shown in fig. 4, 5, 6 and 7, the ablation catheter of the ablation device may also adopt different schemes than those shown in fig. 1 to 3 to achieve the object of the invention of the present application. In fact, fig. 4 to 7 may be divided into different embodiments from each other. In the following description, each of the features of the embodiments of the present application will be described as an example, but it should be noted that the features of the embodiments of the present application may be combined with each other, and these variations are within the scope of the present application, provided that ablation procedures can be performed. In addition, since the present application has been fully described in detail in describing the first embodiment, the common or repeated parts will be simplified or omitted in describing and explaining the second embodiment, and the different personalized features will be explained in detail.
As shown in fig. 4-7, the ablation catheter may include a tubular member 10, a plurality of control shafts 20, and a plurality of ablation assemblies (where "plurality" refers to two or more).
Similarly, the tubular member 10 is flexible and has an operative end and a working end 101. A plurality of control shafts 20 are respectively arranged in parallel and independently from each other and slidably in the tubular member 10; each of the plurality of ablation assemblies is flexible and has an ablation element carrier 12 of a shape memory material, the ablation element carrier 12 carrying a plurality of ablation elements S arranged at a distance from each other.
The main feature of this embodiment is that each ablation assembly is connected to a respective control shaft 20 and is retractable within the tubular member 10 under the urging of the respective control shaft 20 to maintain the linearly extended condition and is extendable from the working end 101 of the tubular member 10 to present a radially expanded portion 121 to the ablation element carrier 12. The radially expandable portion 121 may be helical or annular or other shape; and/or the radially expanding portion is circular, circular arc, oval or the like as viewed in the axial direction of the control shaft 20.
According to the ablation catheter of the present embodiment, it is preferable that the ablation assemblies are extended from the working end 101 of the tubular member 10 to different extents in the axial direction, and the operator can control the respective control shafts 20 of the ablation assemblies to change the relative positions of the radially expanded portions 121 to each other, so as to achieve flexible control.
In the condition of the ablation assemblies extending from the working end 101 of the tubular member 10, the degree of radial expansion of the radially expandable portions 121 of the various ablation assemblies may be the same (as shown in fig. 5, 6 and 7), and the plurality of ablation element carriers 12 may extend parallel to one another; or the degree of expansion in the radial direction of the radially expandable portion 121 may be different for different ablation assemblies (as shown in fig. 4). Preferably, in the condition of the ablation assembly extending from the working end 101 of the tubular member 10, the radially expandable portion 121 of the ablation assembly extending further in the axial direction is expanded to a lesser extent in the radial direction, so that during the ablation procedure, said radially expandable portion 121 extending further is more suitable for deep access to a site inside a blood vessel, while the second expandable portion 122 is more suitable for access to a site at and adjacent the interface of the blood vessel and the heart.
As shown in fig. 4, 6 and 7, the ablation catheter preferably includes a sliding guide 21, and the sliding guide 21 is disposed on the control shafts 20 for guiding the control shafts 20 to slide in the sliding direction parallel to each other, so that a large angular deviation between the control shafts 20 at a position close to the working end 101 can be prevented, thereby reducing the difficulty of operation of the ablation catheter and improving controllability. Wherein each control shaft 20 is slidably provided to a slide guide 21; or at least one control shaft 20 of the plurality of control shafts 20 is fixed to the slide guide 21 and at least one control shaft 20 is slidably provided to the slide guide 21. The sliding fit of the slide guide 21 can be achieved by a sliding structure such as a slide groove or a shaft hole. Preferably, the sliding fit has a predetermined sliding range, which may be achieved by a stop structure (such as a bump or step or circumferential flange, etc.) provided on the control shaft 20 on the sliding path of the slide guide 21. By limiting the slidable range of the slide guide 21, more accurate adjustment can be achieved while allowing position adjustment, improving the accuracy of adjustment.
According to the ablation catheter of the present embodiment, the ablation assemblies can be independent of each other as shown in fig. 4, or the ablation assemblies can be additionally matched as shown in the preferred embodiments of fig. 5, 6 and 7. Through increasing the cooperation relation between the ablation subassembly, not only can more accurately control each position of ablating the subassembly, can also more accurately control each relative position of ablating between the subassembly, more accurate regulation that can do when adjusting.
As shown in fig. 5 and 7, the distal ends E2 of each ablation element carrier 12 may be fixedly attached to one another such that when the control shaft 20 to which the ablation assembly is attached is moved relative to one another, the distal ends E2 of each ablation element carrier 12 remain relatively fixed and the ablation element carriers 12 are stretched or compressed in the axial direction of the tubular member 10 (hereinafter referred to as the axial direction). As shown in fig. 7, the ablation catheter preferably includes a telescoping control shaft 30, the telescoping control shaft 30 being slidably disposed within the tubular member 10, the telescoping control shaft 30 being fixedly attached to the distal end E2 of each ablation element carrier 12, such that the plurality of ablation element carriers 12 can be simultaneously controlled in axial tension or compression by the telescoping control shaft 30 with the control shaft 20 fixed.
As shown in fig. 6, in accordance with another embodiment, the ends E2 of the respective ablation element carriers 12 may also be slidably coupled to one another within a predetermined range of sliding movement. In the case of an ablation catheter including a telescoping control shaft 30, the telescoping control shaft 30 is slidably disposed within the tubular member 10 and fixedly attached to the distal end E2 of the ablation element carrier 12 that extends the furthest outward (distance from the working end of the tubular member 10 in the axial direction) from the tubular member 10 to enable individual control of the relative sliding movement of the distal end E2 of the ablation element carrier 12 with respect to the distal ends E2 of the other ablation element carriers 12 within a predetermined range of sliding movement.
As shown particularly in fig. 6, the ablation assembly preferably includes a first ablation assembly having a first ablation element carrier 31 and a second ablation assembly having a second ablation element carrier 32, with the first ablation element carrier 31 extending outwardly from the tubular member 10 to a greater extent than the second ablation element carrier 32 in a condition in which the ablation assembly extends from the working end 101 of the tubular member 10, with an end E3 of the first ablation element carrier 31 slidably engaging an end E4 of the second ablation element carrier 32 within a predetermined sliding range, and with the telescoping control shaft 30 fixedly connected to an end E3 of the first ablation element carrier 31. According to this embodiment, the end E3 of the first ablation element carrier 31 is individually controllable by the telescoping control shaft 30 to slide within the predetermined sliding range relative to the end E4 of the second ablation element carrier 32; if the control shaft 20 connecting the first ablation element carrying part 31 and the telescopic control shaft 30 are operated synchronously, the ablation elements S of the first ablation element carrying part 31 and the ablation elements S of the second ablation element carrying part 32 can be moved toward or away from each other in the axial direction.
In accordance with the ablation catheter of any embodiment of the present application, the ablation elements S are preferably electrodes for creating an electric field between the ablation elements S for therapeutic purposes of electric field ablation. Preferably, according to a first embodiment, in the condition of the ablation assembly protruding from the working end 101 of the tubular element 10, a plurality of electrodes distributed on at least one of the radially expandable portions 121, 122 are used to generate a circumferential electric field and/or an axial electric field; according to a second embodiment, a plurality of electrodes distributed on the radially expandable portion 121 of each ablation assembly are used to create a circumferential electric field and/or an axial electric field.
As shown in fig. 1, 2 and 3, the circumferential electric field is an electric field formed between the ablation elements S distributed on the same radial expansion portion, and the electric field parameters of the radial expansion portion can be changed by changing the stretching degree of the radial expansion portion; the axial electric field is formed between the ablation elements S on different radially expanded portions distributed along the axial direction of the tubular member 10, and the axial distance between the ablation elements S can be changed by adjusting the postures of the radially expanded portions 121, 122, so as to change the electric field parameters.
In the present disclosure, it is a technical advantage to form a circumferential electric field and/or an axial electric field using a plurality of electrodes distributed on an ablation assembly. In particular, in conventional ablation devices, most provide only a circumferential electric field, do not provide an axial electric field substantially, or even if the axial electric field is weak, or the intensity, spatial distribution is not adjustably optimized.
In the technical solution of the present application, since the ablation elements S can realize a multi-level spatial layout in the circumferential direction and the axial direction, and the ablation assemblies have adjustable degrees of freedom, the adjustability and flexibility of the relative positions in space between different ablation elements S can be realized. Therefore, according to the ablation catheter of the application, the flexible adjustment of the circumferential electric field and/or the axial electric field can be realized so as to adapt to various different specific application conditions.
By flexibly controlling the posture of the ablation element bearing part 12 by the ablation device of any of the above embodiments, the action range of the ablation element S and the intensity of the electric field can be flexibly adjusted. The ablation element S can be set to different functions according to different application condition requirements. For example, the ablation element S may be configured to operatively detect electrical signals of tissue to be treated for testing or diagnosis, and further, the ablation element S may be configured to provide at least one of acoustic (or vibrational) energy, electrical and/or magnetic energy, thermal energy, chemical energy, and radiation energy, so as to select ablation catheters with ablation elements having different functions according to different working requirements, thereby improving the applicability of the ablation device, and enabling the application of the ablation device of the present application to be not limited to catheter rf ablation.
The preferred embodiments of the present application have been described in detail above, but the present application is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solution of the present application within the technical idea of the present application, and these simple modifications all belong to the protection scope of the present application.
It should be noted that, in the above embodiments, the various features described in the above embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, various possible combinations are not described separately in the present application.
In addition, any combination of the various embodiments of the present application can be made, and the same shall be considered as the disclosure of the present application as long as the idea of the present application is not violated.
Claims (17)
1. An ablation catheter, the ablation catheter comprising:
a tubular member (10), the tubular member (10) being flexible and having an operative end and a working end (101);
a plurality of control shafts (20), the control shafts (20) being respectively parallel and independent to each other and slidably disposed in the tubular member (10);
a plurality of ablation assemblies, each ablation assembly being flexible and having an ablation element carrier (12) of a shape memory material, the ablation element carrier (12) carrying a plurality of ablation elements (S) arranged at a distance from each other, each ablation assembly being connected to a respective control shaft (20) and being retractable within the tubular member (10) under the influence of the respective control shaft (20) to maintain a linearly extended state and being extendable from the working end (101) of the tubular member (10) such that the ablation element carrier (12) exhibits a radially expanded portion (121).
2. The ablation catheter of claim 1, wherein the extent to which different ablation assemblies extend in the axial direction is different in a state in which the ablation assemblies extend from the working end (101) of the tubular member (10), the respective control shaft (20) of each ablation assembly being capable of regulating the relative position of the respective radially expandable portion (121).
3. The ablation catheter of claim 1,
in the state in which the ablation assemblies are protruding from the working end (101) of the tubular member (10), the degree of expansion in the radial direction of the radially expanded portions (121) of the different ablation assemblies is the same or different; or
In a state in which the ablation assembly is protruding from the working end (101) of the tubular member (10), a radially expanded portion (121) of the ablation assembly that protrudes further in the axial direction is expanded to a smaller extent in the radial direction.
4. The ablation catheter of claim 1, wherein the radially expanded portion is in the shape of a spiral; or the radially expanding portion is circular as viewed from the axial direction of the main control shaft (11).
5. The ablation catheter according to claim 1, characterized in that the ablation catheter comprises a sliding guide (21), the sliding guide (21) being arranged to the plurality of control shafts (20) for guiding the plurality of control shafts to slide in a sliding direction parallel to each other.
6. The ablation catheter according to claim 5, wherein each control shaft (20) is slidably arranged to the sliding guide (21); or at least one control shaft (20) of the plurality of control shafts (20) is fixed to the slide guide (21) and at least one control shaft (20) is slidably provided to the slide guide (21).
7. The ablation catheter according to claim 5, characterized in that the sliding fit between the sliding guide (21) and the control shaft is achieved by a sliding structure such as a sliding groove or a shaft hole.
8. The ablation catheter of claim 5, wherein the sliding fit between the sliding guide (21) and the control shaft has a predetermined sliding range.
9. The ablation catheter as claimed in claim 1, characterized in that the ends (E2) of the individual ablation element carriers (12) are fixedly connected to one another,
preferably, the ablation catheter comprises a telescoping control shaft (30), the telescoping control shaft (30) being slidably disposed within the tubular member (10), the telescoping control shaft (30) being fixedly attached to a distal end (E2) of each ablation element carrier (12).
10. The ablation catheter of claim 1, wherein the distal ends (E2) of the respective ablation element carriers (12) are slidably connected to one another,
Preferably, the ablation catheter includes a telescoping control shaft (30), the telescoping control shaft (30) being slidably disposed within the tubular member (10) and fixedly attached to the distal end (E2) of the ablation element carrier (12) that extends the furthest outward from the tubular member (10).
11. The ablation catheter of claim 10, wherein the ablation assembly comprises a first ablation assembly having a first ablation element carrier (31) and a second ablation assembly having a second ablation element carrier (32), the first ablation element carrier (31) projecting outwardly from the tubular member (10) to a greater extent than the second ablation element carrier (32) in a condition in which the ablation assembly projects from the working end (101) of the tubular member (10), an end portion (E3) of the first ablation element carrier (31) being in sliding engagement with an end portion (E4) of the second ablation element carrier (32) within a predetermined range of sliding movement,
preferably, the ablation catheter comprises a telescoping control shaft (30), the telescoping control shaft (30) being slidably disposed within the tubular member (10) and fixedly attached to an end (E3) of the first ablation element carrying section (31).
12. An ablation catheter according to claim 1, wherein the ablation element is operable to detect electrical signals of tissue to be treated.
13. The ablation catheter of claim 1, wherein the ablation element is operable to provide electrical energy.
14. The ablation catheter of claim 1, wherein the ablation element is operable to provide thermal energy.
15. The ablation catheter of claim 1, wherein the ablation element is an electrode.
16. The ablation catheter according to claim 15, wherein a plurality of said ablation elements distributed over said radially expanded portion (121) are adapted to form a circumferential and/or an axial electric field in a state in which said ablation assembly is protruding from the working end (101) of said tubular member (10).
17. An ablation device comprising an ablation catheter, a steering handle connected to the ablation catheter, and a controller electrically connected to the ablation catheter, wherein the ablation catheter is the ablation catheter of any one of claims 1-16.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| CN202111070759 | 2021-09-13 | ||
| CN2021110707593 | 2021-09-13 | ||
| CN202111224530.0A CN113662654B (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202111224530.0A Division CN113662654B (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
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| CN114668483A true CN114668483A (en) | 2022-06-28 |
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| CN202210113399.9A Pending CN114668483A (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
| CN202210113402.7A Pending CN114668484A (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
| CN202111224530.0A Active CN113662654B (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
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| CN202210113402.7A Pending CN114668484A (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
| CN202111224530.0A Active CN113662654B (en) | 2021-09-13 | 2021-10-21 | Ablation device and ablation catheter thereof |
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| WO2023125647A1 (en) * | 2021-12-31 | 2023-07-06 | 深圳市先健呼吸科技有限公司 | Ablation apparatus |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1895927A4 (en) * | 2005-06-20 | 2011-03-09 | Medtronic Ablation Frontiers | Ablation catheter |
| US20120197246A1 (en) * | 2011-01-28 | 2012-08-02 | Medtronic Vascular, Inc. | Ablation catheter |
| CN102198015B (en) * | 2011-05-03 | 2013-11-06 | 上海微创电生理医疗科技有限公司 | Retractable spiral laminar ring type electrode catheter |
| US9351789B2 (en) * | 2013-05-31 | 2016-05-31 | Medtronic Ablation Frontiers Llc | Adjustable catheter for ostial, septal, and roof ablation in atrial fibrillation patients |
| CN213758519U (en) * | 2020-09-29 | 2021-07-23 | 杭州睿笛生物科技有限公司 | Cervical ablation device |
| CN112741685A (en) * | 2021-01-12 | 2021-05-04 | 深圳北芯生命科技有限公司 | Ablation catheter and medical device comprising same |
| CN113143444A (en) * | 2021-01-28 | 2021-07-23 | 上海玄宇医疗器械有限公司 | Cardiac pulse electric field ablation catheter device |
| CN113143447A (en) * | 2021-04-09 | 2021-07-23 | 上海捍宇医疗科技股份有限公司 | Device for delivering pulsed electric field ablation energy to endocardial tissue |
| CN113349922A (en) * | 2021-07-06 | 2021-09-07 | 上海安钛克医疗科技有限公司 | Electrophysiology catheter and electrophysiology system |
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| CN114668484A (en) | 2022-06-28 |
| CN113662654A (en) | 2021-11-19 |
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