CN115414113A

CN115414113A - Ablation catheter, catheter device for intravascular treatment, catheter and system

Info

Publication number: CN115414113A
Application number: CN202211037672.0A
Authority: CN
Inventors: 汤敬东; 余波; 张军伟; 龙其财
Original assignee: Shanghai Yingte Weiluo Medical Technology Co ltd
Current assignee: Shanghai Yingte Weiluo Medical Technology Co ltd
Priority date: 2022-08-26
Filing date: 2022-08-26
Publication date: 2022-12-02
Anticipated expiration: 2042-08-26
Also published as: CN115414113B

Abstract

The ablation catheter comprises a supporting shaft tube, an energy applying device and an outer sleeve, wherein the energy applying device is configured to be changed between a conveying configuration and a deployment configuration, each energy applying device further comprises a driving device, an adjustable support device and an energy applying element, the energy applying element is arranged on the support device, a first end of the adjustable support device is installed on the supporting shaft tube, and a second end of the adjustable support device in the deployment configuration can freely move under the action of the driving device to drive the energy applying element to adjust the distance and/or the angle between the energy applying element and the supporting shaft tube so as to control the close contact between the energy applying element and intraluminal tissues. The unfolding configuration is set to be an independent control mode and/or a common control mode, and one mode can be selected to be the current working unfolding configuration.

Description

Ablation catheter, catheter device for intravascular treatment, catheter and system

Technical Field

The present invention relates to an ablation catheter, and more particularly to an ablation catheter, a catheter device for intravascular treatment, a nerve ablation catheter for thromboangiitis obliterans, and a minimally invasive medical system having the catheter.

Background

Ablation therapy plays an increasingly important role in the field of interventional therapy, and as an important carrier of energy transfer, good contact between an ablation electrode and a diseased region is the key to achieving a therapeutic effect. Especially when the ablation electrode is used for treatment in a cavity (such as a blood vessel, a heart, a bronchus and the like), the ablation electrode is easy to loosen from a diseased tissue due to the absence of the limitation of surrounding dense tissues, so that incomplete ablation, failure and even serious complications are caused.

In response to this problem, two main-stream solutions are available, in which the electrodes are brought into contact by pre-shaping the electrode carrier, which is pre-dimensioned to the size of the desired lesion site. The problem with this approach is that there are different anatomical structures for different patients, and the lumen diameters at the same site are not identical, and therefore there is no good compatibility. In another scheme, the invention is a radio frequency ablation catheter with a shape-stabilized designed mesh tubular support structure and a manufacturing process thereof, which is disclosed in patent CN109498147B, and the radio frequency ablation catheter is characterized in that electrodes are loaded on a support with adjustable radial dimension, and the radio frequency ablation catheter can adapt to different lumen internal diameters by adjusting the radial dimension of the loaded support. The problem with this solution is that some luminal lesions are not uniform, which results in a good fit of one part of the electrodes and a poor or no fit of the other part of the electrodes.

The application number of 201220690574.2 of the company Limited of medical apparatus of Beijing discloses a multipoint radio frequency ablation electrode for renal sympathetic nerve removing operation, alternating current is conducted into renal artery tissue through an electrode at the head end of a catheter to generate heat, the temperature is raised (generally to about 65 ℃), partial sympathetic nerves on the renal artery are inactivated at high temperature, and the purpose of blocking partial renal artery sympathetic nerves is achieved, so that the blood pressure is effectively controlled, and a patient who cannot control the blood pressure through common medicines can obtain a healthy constitution again.

Please refer to fig. 1, which is a multi-point rf ablation electrode for renal sympathetic denervation, comprising a handle 1, a catheter 2, an electrode 3, a fixed head end 4, a pull wire 5 and an elastic crank arm 6, wherein the pull wire 5 is located in a lumen of the catheter 2 and is respectively connected with the fixed head end 4 and the handle 1, the elastic crank arms 6 are provided in plurality, one end of the elastic crank arm 6 is connected with the fixed head end 4, the other end is connected with the catheter 2, and under the pulling force of the pull wire 5, the distance between the fixed head end 4 and the catheter 2 is shortened, so that the elastic crank arm 6 is elastically deformed, and the elastic crank arms 6 are opened to form a lantern shape (as shown in fig. 2). Each elastic crank 6 is provided with an electrode 3, the electrode is preferably made of platinum metal with good conductivity and biocompatibility, and the lantern-shaped elastic crank 6 can enable the electrode 3 to be tightly attached to the inner wall of the blood vessel.

Referring to fig. 2, the flexible crank arm 6 of the ablation electrode (also called ablation catheter) is fixed at both ends (one end is connected to the fixed head end 4, the other end is connected to the catheter 2), the electrode 3 is arranged on the flexible crank arm 6, the flexible crank arm is similar to a support of a lantern frame, and the distance between the fixed head end 4 and the catheter 2 of the flexible crank arm 6 is adjusted under the action of the pull wire 5, so as to achieve the purpose of stretching to be lantern-shaped or folding to be shuttle-shaped.

The lantern-shaped structure has the problems of complex structure and high manufacturing difficulty, and in addition, the radial size of the folded lantern-shaped structure is large, so that the lantern-shaped structure is not suitable for application scenes with small movable space.

Disclosure of Invention

The invention aims to provide an ablation catheter, which aims to solve the problems of complex structure and high manufacturing difficulty of a lantern-shaped structure.

A second object of the present invention is to provide a catheter device for intravascular treatment, which solves the problems of complicated structure and difficulty in manufacturing a catheter lantern-shaped structure used in blood vessels.

The third purpose of the invention is to provide a nerve ablation catheter for thromboangiitis obliterans, so as to solve the technical problem that no catheter suitable for thromboangiitis obliterans is available in the prior art.

It is a fourth object of the invention to provide a medical minimally invasive system.

A first aspect of the present invention provides an ablation catheter for performing ablation of a target tissue, comprising:

a support shaft tube;

a plurality of individually controllable energy application devices configured to be changed between a delivery configuration and a deployed configuration, each energy application device further comprising a driving device, an adjustable stent device and an energy application element for applying energy to the tissue, the energy application element being disposed on the stent device, a first end of the adjustable stent device being mounted on the support shaft tube, a second end of the adjustable stent device being freely movable in the deployed configuration under the action of the driving device to drive the energy application element to adjust a distance and/or an angle between the energy application element and the support shaft tube, and the driving device, the adjustable stent device and the energy application element being disposed along a conduit direction of the support shaft tube in the delivery configuration, the energy application elements forming a shape to embrace the support shaft tube;

an outer tube configured to be relatively movable with respect to the support shaft tube, the support shaft tube being contracted between the outer tube and the support shaft tube in an inner state of the outer tube, the energy applying unit being protruded outside the outer tube in a state where a distal end of the support shaft tube is protruded outside the outer tube;

and in the unfolded configuration state, the driving device corresponding to the energy applying device matched with the target tissue is driven to drive the second end of the adjustable bracket device to move, and the distance and/or the angle between the energy applying element and the supporting shaft tube are/is adjusted to realize the control of the close contact between each energy applying element and the target tissue.

Preferably, the energy applying elements are formed in a shape capable of encircling the supporting axle tube and comprise: the energy applying elements are not overlapped and are respectively attached to the supporting shaft tube, so that the pipe diameter formed by the energy applying elements and the supporting shaft tube is small.

Preferably, the energy applying elements are arranged along the outer surface of the supporting shaft tube in a staggered mode, and the shape of the energy applying elements is matched with the outer arc surface of the supporting shaft tube. The catheter further comprises the catheter in a pre-expanded configuration: the outer sleeve is actively or passively slid in another direction to expose at least a portion of the energy application devices, the energy application elements being in a micro-expanded state.

Preferably, the energy application elements are in a micro-expanded state further comprising: at least one part of the at least one energy applying element is spaced from the outer surface of the supporting shaft tube by an angle not less than 1 degree, so that the at least one energy applying device is expanded to easily drive the adaptive energy applying element.

The present invention provides a second ablation catheter for performing ablation of a target tissue, comprising:

a support shaft tube;

at least one energy application device configured to change between a delivery configuration and a deployment configuration, the energy application device further comprising a driving device, an adjustable stent device and an energy application element for applying energy to the tissue, the energy application element being arranged on the stent device, a first end of the adjustable stent device being mounted on the support shaft tube, a second end of the adjustable stent device being freely movable in the deployment configuration under the action of the driving device to drive the energy application element to adjust a distance and/or an angle between the energy application element and the support shaft tube,

in the unfolded configuration state, the driving device corresponding to the energy application device is driven to drive the second end of the adjustable bracket device to move, and the distance and/or the angle between the energy application element and the supporting shaft tube are/is adjusted to realize the control of the close contact between the energy application element and the target tissue.

Preferably, the number of the energy application devices is at least two, and the catheter further comprises a common driving member, the driving devices corresponding to the energy application devices are respectively connected with the common driving member, and the common driving member is configured to drive the driving devices to jointly act in a driving state in the unfolding configuration, so as to adjust the distance and/or the angle between the corresponding energy application element and the support shaft tube.

Preferably, the common driving member includes a snap ring and a snap ring triggering unit, the driving devices corresponding to the energy applying devices are respectively connected to the snap ring, the snap ring is disposed between the supporting shaft tube and the outer sleeve, the snap ring is stored in the outer sleeve in the conveying configuration, and the snap ring triggering unit is triggered to drive the snap ring to move proximally along the outer sleeve in the unfolding configuration, so as to drive the driving devices to act together.

Preferably, the snap ring triggering unit is at least two symmetrically arranged common pulling wires, which are designed along the pipeline direction of the supporting shaft tube.

Preferably, the driving device, the adjustable bracket device and the energy applying element are respectively a traction wire, a bracket device and an electrode unit, the bracket device further comprises a support rod and a fixing member for fixing one end of the support rod, the electrode unit is arranged at a second end of the support rod far away from the fixing member, and the traction wire is designed along the pipeline direction of the support shaft tube. The traction wires are fixedly and respectively provided with corresponding transmission stop blocks at one side of the common driving piece close to the near end, and are set to be an independent control mode and a common control mode under the unfolding configuration, wherein one mode can be selected to be the unfolding configuration of the current work, and the independent control mode comprises the following steps: the traction wires can be independently pulled to drive the corresponding support rods to leave the support shaft tube so as to adjust the close contact degree between the support rods and the target tissue; the common control modes include: the common driving piece is configured to be in a driving state, and the transmission stop blocks simultaneously move towards the near end to drive the driving devices to jointly act.

The third scheme provided by the invention is as follows: a catheter device for intravascular treatment, comprising:

a support shaft tube having a proximal portion and a distal portion;

a carrier carrying at least one therapeutic component, wherein the carrier is located at or near the distal portion of the elongate shaft, an

Wherein the treatment assembly comprises at least one treatment member for intravascular treatment; wherein the carrier is configured to change between a delivery configuration and a deployed configuration; the distal portion of the shaft is configured for intravascular delivery of the carrier,

the unfolding configuration at least comprises at least one energy applying device, each energy applying device further comprises a driving device, an adjustable bracket device and an energy applying element for applying energy to the tissue, the energy applying element is arranged on the bracket device, the first end of the adjustable bracket device is arranged on the supporting shaft tube, the second end of the adjustable bracket device can freely move under the action of the driving device, and the energy applying element is driven to adjust the distance and/or the angle between the energy applying element and the supporting shaft tube so as to realize the control of the close contact of the energy applying element and the target tissue in the blood vessel.

The fourth scheme provided by the invention is as follows: a nerve ablation catheter for thromboangiitis obliterans, comprising:

a support shaft tube having a proximal portion and a distal portion;

the deployment configuration at least comprises at least one energy application device, each energy application device further comprises a driving device, an adjustable bracket device and an energy application element for applying energy to the tissue, the energy application element is arranged on the bracket device, the first end of the adjustable bracket device is arranged on the supporting shaft tube, the second end of the adjustable bracket device can move freely under the action of the driving device, the energy application element is driven to adjust the distance and/or the angle between the energy application element and the supporting shaft tube so as to realize the tight contact of the energy application element and the target tissue in the blood vessel, and the energy application element is applied with energy so as to inactivate the concomitant nerves on the inner wall of the blood vessel under high temperature.

Preferably, in the delivery configuration, the driving device, the adjustable stent device and the energy applying elements are arranged along the pipeline direction of the support shaft tube, and the energy applying elements are formed into a shape capable of encircling the support shaft tube so as to be suitable for catheter delivery in the area where the tube diameter inside the lumen part is reduced due to pathological tissues.

Preferably, there are at least two individually controllable energy application devices, the catheter further comprises a common driving member, the driving devices corresponding to the energy application devices are respectively connected to the common driving member,

in the unfolded configuration, the common driving member is configured to drive the driving devices to act together to adjust the distance and/or angle between the corresponding energy applying element and the supporting shaft tube.

The fifth scheme provided by the invention is as follows: a medical minimally invasive system comprising a catheter as mentioned in any of the above.

Compared with the prior art, the invention has the following advantages:

firstly, the energy applying device has simple structure and convenient manufacture, is suitable for mass manufacture and can meet certain precision requirements.

Further, the present invention employs a plurality of individually controllable energy application devices, each of which may be configured identically, e.g., including a drive device, an adjustable bracket device, and an energy application element for applying energy to tissue. The advantage of this design is that the components of the energy application device are arranged the same, and the dimensions can be the same. When the space for ablation of the target tissue is less than 5mm, parts of the same size and dimensions have the potential for greater manufacturing precision and greater batch processing capability.

And thirdly, in the unfolding configuration state, the electrode unit matched with the pre-ablated tissue in the tube cavity can be accurately controlled. The location of the pre-ablated tissue within the lumen determines the location of catheter travel. The current shape of the tissue is pre-ablated, which electrode unit or electrode units are controlled respectively, the distance and/or the angle of adjustment of the guide wire drive are determined, the corresponding traction wire drive is controlled independently to drive the second end of the adjustable bracket device to move, and the distance and/or the angle between the electrode unit and the supporting shaft tube are adjusted to realize the accurate control of the close contact of each electrode unit and the tissue in the lumen, particularly when the tissue in the lumen is in an irregular shape, each independent energy applying device is controlled respectively to achieve the close contact of each electrode unit and the tissue in the lumen.

Subsequently, when the catheter is in a conveying configuration, the driving device, the adjustable bracket device and the energy applying elements are arranged along the length direction of the body of the supporting shaft tube, the energy applying elements form a shape capable of encircling the supporting shaft tube, the thickness of the energy applying elements and the diameter of the lumen of the supporting shaft tube directly determine the diameter of the catheter, and when the thickness of the energy applying elements is small enough, the catheter can be applied to more scenes, particularly to the situation that the lumen of some application scenes is thin.

Finally, the independent control mode and the common control mode are set in the unfolding configuration, one of the modes is the current working unfolding configuration, wherein, the independent control mode comprises the following steps: the driving device (such as a traction wire) can be independently dragged to drive the corresponding bracket device to leave the supporting shaft tube so as to adjust the close contact degree between the electrode unit and the target tissue; the common control modes include: the common driving member is configured in a driving state, the traction wires move towards the near end simultaneously to drive the driving devices to act together. The invention can only push out a catheter structure with the electrodes acting together, can also be a catheter structure with each electrode controlled independently, can also push out a catheter structure with the electrodes controlled together and also controlled independently, and has wide application range.

Drawings

FIG. 1 is an exemplary illustration of a multi-point RF ablation electrode for renal denervation;

FIG. 2 is an exemplary view of an unfolded structure of a lantern-shaped electrode;

FIG. 3 is a schematic view of an embodiment of a delivery configuration of the ablation catheter;

FIG. 4 is a schematic view of an embodiment of an ablation catheter in a deployed configuration;

FIGS. 5A and 5B are front and side views, respectively, of part of the structure of an energy application device;

FIG. 6 is an exemplary view showing an electrode assembly made of memory alloy in a naturally expanded state at an angle to a support shaft tube when an outer tube is opened;

FIG. 7A is an example view of an ablation catheter partially within a lumen;

FIG. 7B is an exemplary cross-sectional view of the ablation catheter partially within the lumen;

FIG. 8 is a flow chart of one method of use of the ablation catheter;

FIG. 9A is a diagram of a delivery state of the example ablation catheter structure of FIG. 4; FIG. 9B is an internal block diagram of the ablation catheter in a delivery state, and FIG. 9C is an exemplary diagram of the ablation catheter in a pre-expanded configuration; FIG. 9D is an axial view of the ablation catheter in a pre-expanded configuration with the electrodes in a micro-expanded state;

FIG. 10A is an exemplary view of a first configuration of an expander electrode, the electrodes being in the same circumferential plane; FIG. 10B is an exemplary view of a second configuration of the expander electrode in two circumferential planes; FIG. 10C is an exemplary view of a third configuration of expander electrodes in a different circumferential plane;

fig. 11A is a view showing an example of the structure of a third embodiment of an ablation catheter;

FIG. 11B is another structural example of the third embodiment of the ablation catheter;

fig. 12 is a schematic diagram of the system.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It is to be understood that the terms "central," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in an orientation or positional relationship that is indicated based on the orientation or positional relationship as shown in the figures, which is for convenience in describing the invention and in order to simplify the description, and is not intended to indicate or imply that the device or element so referred to must have a particular orientation, be constructed in a particular orientation, and be operated in a particular orientation, and is not to be construed as limiting the invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

It should be noted that unless expressly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly and include, for example, fixed or removable connections or integral connections; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

Referring to fig. 2, the applicant found during product development that the elastic crank arm 6 of the ablation electrode (also called ablation catheter) is fixed at both ends (one end is connected to the fixed head end 4, and the other end is connected to the catheter 2), the electrode 3 is disposed on the elastic crank arm 6, the elastic crank arm is similar to a support of a lantern frame, and the distance between the fixed head end 4 and the catheter 2 of the elastic crank arm 6 is adjusted under the action of the pull wire 5, so as to achieve the purpose of spreading or furling to form a lantern shape. This structure has several problems: 1) The structure is complex and is not easy to produce and assemble 2) the structure principle can not control each elastic crank arm 6 independently, and the lantern shape can only stretch or furl all the elastic crank arms 6 and can not adapt to the application occasions with irregular tube cavities. 3) Even if the space exists between each adjusting elastic crank arm 6 and the catheter 2 in a folded state, the diameter of the ablation electrode in the folded state is thicker, and the ablation electrode cannot be applied to a lumen with smaller diameter.

First embodiment

To this end, the present invention provides an ablation catheter that may be used to perform ablation of intraluminal tissue. For example, the catheter may be a pulsed field ablation catheter. A pulsed field ablation catheter can be used to ablate diseased tissue. The pulsed field ablation catheter can be used to ablate a variety of diseased tissues (e.g., lesions) at different locations in the body. For example, the pulsed field ablation catheter can be used for focal ablation of blood vessels, trachea, bronchi, intestinal tract (e.g., large intestine, small intestine, duodenum, etc.), gall bladder, heart, etc. For another example, the pulse field ablation catheter can be used for ablation of relevant focuses such as blood vessels, bronchitis, emphysema, hyperplasia and hypertrophy of bronchial glands, atrial fibrillation, local hyperplasia tumors and the like.

Referring to fig. 3, an exemplary embodiment of an ablation catheter for performing ablation of a target tissue includes:

a supporting shaft tube 10;

a plurality of individually controllable energy application devices 20 configured to change between a delivery configuration and a deployment configuration, each energy application device further comprising a driving device 21, an adjustable stent device 22 and an energy application element 23 for applying energy to the tissue, the energy application element 23 being disposed on the stent device 11, a first end 221 of the adjustable stent device 22 being mounted on the support shaft tube 10, a second end 222 in the deployment configuration being freely movable under the action of the driving device 21 to drive the energy application element 23 to adjust a distance and/or an angle between the energy application element and the support shaft tube 10, and, in the delivery configuration, the driving device 21, the adjustable stent device 22 and the energy application element 23 being disposed along a length of the support shaft tube 10, the energy application elements 23 forming a shape capable of embracing the support shaft tube 10;

an outer tube 30 configured to be relatively movable with respect to the support shaft tube, the support shaft tube being contracted between the outer tube and the energy applying unit in an inner state of the outer tube, the energy applying unit being protruded outside the outer tube in a state where a distal end of the support shaft tube is protruded outside the outer tube.

In the unfolded configuration, the energy application device 20 adapted to the target tissue is controlled to independently control the corresponding driving device to drive, so as to drive the second end 222 of the adjustable bracket device 22 to move, and the distance and/or angle between the energy application elements 23 and the support shaft tube 10 is adjusted, so as to control the close contact between each energy application element and the target tissue.

Each specific structure and its corresponding operating principle are described in detail.

The energy application device 20 provides a means for applying energy to the intraluminal tissue, and the energy application device 20 may be configured to deliver energy at the treatment site and provide a therapeutically effective electrically and/or thermally induced medical effect. The energy application device 20 may be an electrode unit in a pulsed field ablation catheter or a high temperature device that generates high temperatures. When the electrode unit is used in a high-frequency operation, the high-frequency high-voltage current generated by the effective electrode unit can heat the tissue body when contacting with the body, so that the tissue of the body is treated, and the ablation effect is achieved. The energy application device 20 is exemplified by an electrode unit, but is not limited thereto. In addition, an energy generating device that generally supplies energy to the electrode unit may be connected to the energy application device 20. The main function of the support shaft tube 10 is to support the guide tube and to run the wires. The wires connected with the energy application means 20 may be disposed in the inner tube of the support shaft tube 10, and when the adjustable bracket means 22 and the energy application member 23 for applying energy to the tissue are integrally formed, the wires passing through the inner tube of the support shaft tube 10 may be directly connected with the bracket means 22 without the wires being directly exposed on the outer surface of the support shaft tube 10, which is not only beautiful but also does not cause troubles in use.

The shape of the electrode unit is not limited to a shape and a structure, but one example of the electrode unit is a sheet-like structure. The electrode unit may be preformed in a shape in which both ends are bent inward as shown in fig. 3. The shape of the energy application member 23 (e.g., the electrode unit) can be adapted to the outer arc surface of the tube body provided to the support shaft tube 10. The electrode units can be formed by memory materials which can keep the shape, even after the electrode units are forced to take a flat shape by external force, when the external force disappears, the electrode units can return to the shape of the cambered surface of the pipe body to be matched. The design not only can make the catheter with small diameter, but also can ensure that the shape of the electrode unit can be matched with that of the target tissue, so that the electrode unit and the target tissue are tightly combined easily during subsequent ablation. In some embodiments, the energy application device 20 may be actuated via a remote control in a deployed configuration or arrangement, e.g., an actuator may be a knob, pin, lever, or the like carried by a handle. However, in other embodiments, the carrier 6 energy application device 20 is movable between the delivery and deployed configurations using other suitable mechanisms or techniques (e.g., self-expanding).

In this example, a plurality of individually controllable energy application means 20, each energy application means 20 may be configured identically, for example comprising a drive means 21, an adjustable bracket means 22 and an energy application element 23 for applying energy to the tissue. The benefit of this design is that the components of the energy application device 20 are identical and the dimensional specifications can be identical. When the space for ablation of the target tissue is less than 5mm, parts of the same size and dimensions have the potential for greater manufacturing precision and greater batch processing capability.

The energy application elements 23 are shaped to embrace the supporting shaft tube 10, in particular when the following design is made: the energy applying elements 23 are not overlapped and respectively attached to the support shaft tube 10, so that the pipe diameter formed by the energy applying elements 23 and the support shaft tube 10 is very small, and the application range is wider. The application range is wider, and the method has two layers of meanings: 1) Before the ablation catheter enters the position of the target tissue, the ablation catheter generally needs to be configured into a form smaller than the outer contour or a form that the energy applying device 20 is folded and attached to the support shaft tube 10, and the target tissue can be reached through a section of intervention path (generally, the path planning is firstly performed), and when the intervention path has a narrow passage region, the catheter with a very small pipe diameter is designed, the catheter of my department can be suitable for the application scenes. 2) When the ablation catheter enters the position of the target tissue, and the position of the target tissue enables the space of the catheter to be extremely narrow when the catheter is unfolded during ablation, the catheter of my department can be suitable for the application scenes.

In addition, the energy application elements 23 may be arranged in various patterns. The structure, arrangement, and form of the energy application elements 23 of this example are merely examples. The energy application elements are staggered along the outer surface of the support shaft tube. Figure 3 shows a staggered arrangement. For example, the forward direction near the support shaft tube 10 is defined as the distal end, and the end closer to the operator during operation is defined as the proximal end. When the number of the energy applying elements is 4, a first energy applying element, a second energy applying element, a third energy applying element and a fourth energy applying element are respectively disposed along the outer surface of the support shaft tube 10 from the distal end in the circumferential direction. The second energy application element may be positioned adjacent to (near the proximal direction) below the first energy application element 823030until the fourth energy application element is near below the third energy application element. When the energy application elements 23 are operated together, the high temperature due to the generated energy can be effectively dispersed without being directly concentrated. Of course, a second energy application member may be disposed adjacent to the lower portion (proximal direction) of the first energy application member, and a third energy application member may be disposed adjacent to the upper portion of the second energy application member, and also may be disposed in a staggered arrangement along the outer surface of the support shaft tube 10, the above-mentioned staggered arrangement being a broad explanation and not intended to limit the present example. The staggered arrangement may be in the initial state, with the energy application elements in the same circumferential plane, or in different circumferential planes. Generally, the structure and shape of the energy applying elements are generally related to the target tissue to be acted and the adaptive application scene, and the adaptive energy applying elements can be set according to the requirement on heat dissipation and the related situation of the target tissue.

The shape of the energy application elements 23 in the example is adapted to the outer contour of the tube body provided for the support shaft tube 10. This design makes it easier to reduce the size of the catheter tube diameter. Furthermore, the shape of the energy application elements 23, in particular the contact surface with the target tissue, may be configured to be adapted to the target tissue, so as to increase the contact area as much as possible. The contact surface of the energy application elements 23 with the target tissue may be configured to have a curved configuration similar to the target tissue, and may be easily conformed thereto when in contact. The contact surface may also be provided as a non-smooth type (e.g., the surface has a plurality of curved structures to increase contact, etc.).

The ablation catheter is currently operated in several ways:

the initial state: the energy application device 20 is furled to the support shaft tube 10, the energy application devices are configured to be in a delivery configuration in a compressed configuration (i.e., furled to the support shaft tube 10), and the energy application device is disposed between the outer sleeve and the support shaft tube.

(II) a conveying configuration: the catheter can reach the position of the target tissue through an intervention path, and the energy application devices are folded and stored in the outer sleeve;

(iii) the catheter is in a deployed configuration:

the first case is in a pre-expanded configuration: the outer sleeve 30 is actively or passively slid in another direction to expose at least a portion of the energy application devices 20 with the energy application elements 23 in a slightly expanded state. The energy application elements 23 in a micro-expanded state further comprising: at least a portion of the at least one energy application element 23 is spaced from (i.e., spaced from) the outer surface of the support shaft tube 10 at an angle of not less than 1 degree to facilitate expansion of the at least one energy application device 10 to drive the adapted energy application element.

The second case is the independent control of the deployed configuration: the energy application devices 20 are configured in a deployed configuration that further includes: configured in at least one energy application element 23 expanded configuration. The driving device 21 corresponding to the energy applying device 20 adapted to the target tissue is driven to move the second end 22 of the adjustable bracket device 22, and the distance and/or angle between the energy applying elements 23 and the support shaft tube 10 is adjusted to control the close contact between each energy applying element 23 and the target tissue.

The catheter may be in the deployed configuration multiple times during one ablation procedure. For example, the catheter may be repositioned (including moved, rotated, etc.) and the catheter is again in the deployed configuration for new target tissue.

(IV) end State

The driving device 21 is restored to reset the energy applying element 23, the energy applying element 23 is still in a slightly expanded state, the support shaft tube 10 is retracted or the outer sleeve 30 is pushed forward, the energy applying element 23 is retracted into the outer sleeve 30, and then the catheter is retracted.

It should also be noted that the independently controlled deployment configuration includes deployment of multiple energy application element deployment configurations, and that the catheter is selectively operable in one of the multiple energy application element deployment configurations, one energy application element deployment configuration corresponding to one of the multiple energy application element deployment configurations in the same circumferential plane, in two circumferential planes, and in multiple circumferential planes. This will be described by way of a specific example.

The above structure is only exemplary, and the core points are summarized as follows: the first electrode unit 231, the second electrode unit 232, the third electrode unit 233 and the fourth electrode unit 234 can independently adjust the distance and/or angle between the first electrode unit 231, the second electrode unit 232, the third electrode unit 233 and the fourth electrode unit 234 and the support shaft tube 10. The four electrode units are as close as possible to the support shaft tube 10 when in the non-deployed configuration, in which case the thickness of the electrode units and the tube diameter thickness of the support shaft tube 10 determine the tube diameter of the catheter. When the thickness of the electrode unit is taken as millimeter or smaller size, the catheter can be small enough, is suitable for tissue ablation in a smaller pipe diameter, and greatly improves the application scene. The first electrode unit 231, the second electrode unit 232, the third electrode unit 233 and the fourth electrode unit 234 are only examples, the number of the electrode units forming a shape capable of encircling the supporting shaft tube 10 is not limited, and the shape and the size of the electrode units determine the maximum number of the electrode units capable of being arranged around the supporting shaft tube 10.

The driving device 21 is used to control the operation of the adjustable support device, so as to drive the energy applying element 23 to act. The actuation means 21 may be implemented in a variety of configurations, in this case a handle or other user input device operable by a user at its proximal end to control the operation of its actuation means 21. In this example, the driving device 21 may be a traction wire, which will be described in detail later.

Referring to fig. 6, when the energy application elements are attached to the supporting shaft tube, at least a portion of the energy application elements and the outer surface of the supporting shaft tube are spaced at an angle not less than 1 degree, so as to expand the energy application device to easily drive the adaptive energy application elements. The design ensures that the distance between the energy applying element and the outer surface of the supporting shaft tube can be adjusted by applying little force without overcoming the close attaching force of the energy applying element closely attached to the supporting shaft tube in each unfolding state. The energy application element in this example can be made of a memory alloy, which is manufactured in a state in which a small gap between the energy application element and the support shaft tube is already present in a slightly open state. Moreover, each time the configuration is delivered, the energy application elements return to the pre-set slightly naturally open state due to the effect of the memory alloy material. If the energy application element and the adjustable holder device can be made of memory alloy, the angle range between the energy application element and the adjustable holder device can be set in this state. When the driving device 21 is operated, an angle between the energy applying element and the adjustable bracket device is calculated in advance from the angle of the force, so that the better acting force is exerted, and the angle between the energy applying element and the adjustable bracket device is made in advance by using the memory alloy material.

One specific structure of the energy application device 20 is described below. Drive arrangement, adjustable support device and energy application component can be respectively for traction wire, support device and electrode unit, and support device 22 further includes the mounting 25 of bracing piece 24 and fixed support bar 24 one end, and electrode unit 23 sets up the second end of keeping away from mounting 25 at bracing piece 24, and the traction wire is along the pipeline design of supporting the central siphon, and the traction wire drives the bracing piece and leaves the supporting central siphon under pulling to this degree of close contact between accurate adjustment electrode unit and the intraluminal tissue. Referring to fig. 5A and 5B, the support rod 24 is provided with a hole, and the pull wire is movably connected through an elbow 241 penetrating through the hole, which is just an example, and the pull wire and the support rod 24 may have a certain movable connection, and the implemented structure is not limited to the structure shown in fig. 5A and 5B.

The haulage wire includes first end, intermediate part and operating portion, and first end sets up at the bracing piece on the pole that is close to the second end of electrode unit below, the intermediate part passes and sets up a fixed knot on the surface of supporting the central siphon, the intermediate part with the operating portion sets up along supporting the central siphon body direction, and during the operating portion drive, the intermediate part can movably pass the fixed knot adjustment and be in traction force on the electrode unit. Considering that catheters are invasive to the human body, in general, it is strived to achieve optimal functionality with a minimum of components. In an example, the fixing knot can be omitted, and the intermediate portion and the operating portion can be disposed along the direction of the support shaft tube body by using the outer sleeve as a support point.

The electrode unit 23, the support rod 24, and the fixing member 25 may be integrally formed or may be separately assembled. The support rod 24 has a first end connected to the electrode unit 23 and a second end connected to the fixing member 25. The shapes of the electrode unit 23 and the fixing member 25 are matched with the outer arc surface of the tube body at the installation position of the supporting shaft tube. The first end of the pull wire is fixedly mounted directly to the support rod 24. The back of the support rod 24 may also be grooved and the first end of the pull wire may be disposed in the groove to reduce the diameter of the catheter. As shown in fig. 5A and 5B. The support rod 24 is provided with a hole in the background, and the first end of the traction wire directly penetrates through the hole and then is directly fixed, and the above functions can be realized by the same principle.

The energy application device 20 may further include an angle adjusting unit for adjusting a deflection angle of the electrode unit, and a pull wire is connected to the angle adjusting unit. The angle adjusting unit can be adjusted slightly, i.e. the range of the adjusting angle is smaller. An angle adjusting unit comprises an angle adjuster which has a certain width and is positioned on the back of a supporting rod, and when a first end part of a traction wire is positioned in a certain width, an electrode unit is a deflection angle corresponding to a certain range.

The electrode unit and the support bar may be made of a memory material, and an angle set between the electrode unit and the support bar may be preset.

Similarly, the fixing pieces are arranged along the outer surface of the supporting shaft tube in a staggered mode, and the shape of the energy applying elements is matched with the outer arc surface of the tube body at the installation position of the supporting shaft tube. The shape of the supporting rod is matched with the outer arc surface of the pipe body at the mounting position of the supporting shaft pipe.

The core of this example is that in the deployed configuration, the target tissue-adapted electrode units can be controlled independently. Referring to fig. 7A and 7B, the location of the pre-ablated tissue within the lumen 5 determines the location of the catheter advancement. The current shape of the tissue to be pre-ablated determines which electrode unit or units are to be controlled separately, the distance and/or angle of adjustment of the guidewire drive, the present example independently controls the corresponding traction wire drive to move the second end of the adjustable stent device, and adjusts the distance and/or angle between the electrode units and the support shaft tube to achieve precise control of the close contact between each electrode unit and the tissue in the lumen, or referring to fig. 7B, particularly when the tissue in the lumen is irregular, each independent energy application device 20 is controlled separately to achieve close contact between each electrode unit and the tissue in the lumen. As can be seen from the example shown in the figure, the cross section of the lumen 5 is an oval structure, and the distances between the electrodes are adjusted to be different for the close contact between the electrode units and the tissue in the lumen.

Second embodiment

Referring to fig. 8, this example illustrates a flow chart of a method of using an ablation catheter. It is used for performing ablation of target tissue, comprising:

s110, providing an ablation catheter: the energy application device comprises a support shaft tube, a plurality of energy application devices which can be controlled independently and an outer sleeve tube, wherein the energy application devices can be changed between a conveying configuration and a deployment configuration, each energy application device further comprises a driving device, an adjustable bracket device and an energy application element for applying energy to tissues, the energy application element is arranged on the bracket device, a first end of the adjustable bracket device is arranged on the support shaft tube, and a second end of the adjustable bracket device can move freely under the action of the driving device in the deployment configuration to drive the energy application element to adjust the distance and/or the angle between the energy application element and the support shaft tube.

And S120, the supporting shaft tube is contracted into the outer sleeve to form a conveying configuration, and the energy applying device is stored between the outer sleeve and the supporting shaft tube. In this step, the catheter is in the initial state described above: the energy application devices 20 are furled to the support shaft tube 10 and are configured to be in a compressed configuration (i.e., furled to the support shaft tube 10) in a delivery configuration.

S130, the catheter is delivered to a target position corresponding to the target tissue. This step, with the catheter in the delivery configuration: the catheter can reach the position of the target tissue through an interventional path, and the energy application devices are folded and stored in the outer sleeve.

S140, the support shaft tube and the outer cannula are relatively moved, the support shaft tube protrudes outside the outer cannula, and the at least one energy application device protrudes outside the outer cannula and can be further driven into a deployed configuration such that the energy application element is in contact with the target tissue and is configured to deliver energy to the target tissue. The at least one energy application device being configured to be further expandable outwardly into a deployed configuration further comprises: and driving a driving device corresponding to the energy applying device matched with the target tissue to drive the second end of the adjustable bracket device to move, and adjusting the distance and/or angle between the energy applying elements and the supporting shaft tube so as to realize the control of the close contact between each energy applying element and the target tissue.

In this step, the catheter is in the deployed configuration:

the first case is in the pre-expanded configuration: the outer sheath 30 is actively or passively slid in another direction to expose at least a portion of the energy application devices 20 with the energy application elements 23 in a slightly expanded state.

The second case is the independent control of the deployed configuration: the energy application devices 20 are configured in a deployed configuration that further includes: configured in at least one energy application element 23 expanded configuration. The driving device 21 corresponding to the energy applying device 20 adapted to the target tissue is driven to move the second end 222 of the adjustable bracket device 22, and the distance and/or angle between the energy applying elements 23 and the support shaft tube 10 is adjusted to control the close contact between each energy applying element 23 and the target tissue.

The catheter may be in the deployed configuration multiple times during a single ablation procedure. For example, the catheter may be repositioned (including moved, rotated, etc.) and the catheter is again in the deployed configuration for the new target tissue. The energy application elements 23 controlled may be the same or different each time they are deployed in a configuration state. The energy application member 23 is controlled to adjust its distance from the support shaft tube 10. The number of controls may be different.

The procedure generally further includes S150 ending the process of restoring the driving device 21, repositioning the energy application element 23 while the energy application element 23 is still in a slightly expanded state, retracting the support shaft tube 10 or pushing the outer sleeve 30 forward, retracting the energy application element 23 into the outer sleeve 30, and retracting the catheter.

Similarly, the energy application elements in a micro-expanded state further comprise: at least one part of the at least one energy applying element is spaced from the outer surface of the supporting shaft tube by an angle not less than 1 degree, so that the at least one energy applying device can easily drive the adaptive energy applying element to expand.

Referring to fig. 9A-9D, fig. 9A is a diagram illustrating a delivery state of the exemplary ablation catheter structure of fig. 4; FIG. 9B is an internal block diagram of the ablation catheter in a delivery state, and FIG. 9C is an exemplary diagram of the ablation catheter in a pre-expanded configuration; fig. 9D is an axial view of the ablation catheter in a pre-expanded configuration with the electrodes in a micro-expanded state. From the above exemplary figures, various state illustrations corresponding to one method of use of the ablation catheter can be clearly seen.

Referring to fig. 10A-10C, fig. 10A is an illustration of a first form of an expander electrode, the electrode being in a circumferential plane; FIG. 10B is an exemplary view of a second configuration of expander electrodes in two circumferential planes; fig. 10C is an illustration of a third configuration of expanded electrodes in different circumferential planes. It should be noted that: 1) expanding a first configuration of the electrode, the electrode being in a same circumferential plane 2) expanding a second configuration of the electrode, the electrode being in two circumferential planes 3) expanding a third configuration of the electrode, the electrode being in different circumferential planes. The catheter may be a single structure catheter, and different configurations of fig. 10A-10C may be achieved by controlling different forces on different pull wires.

That is, the at least one energy application device being configured to be further expandable outwardly into the deployed configuration further comprises:

pre-configuring a plurality of energy application element expansion configurations; an energy applying element expansion form corresponds to one working form of the energy applying elements on the same circumferential plane, two circumferential planes and a plurality of circumferential planes;

in the deployed configuration, the catheter is selectively operable in one of the energy application element expanded configurations.

The at least one energy application device further comprises, after being configured to be further expandable outwardly into a deployed configuration: after the catheter is rotated a number of degrees (and/or the catheter is moved a number of distances), the at least one energy application device is configured to expand further outward into the deployed configuration, adjusting the distance and/or angle between the energy application element and the support shaft tube to achieve controlled intimate contact of the energy application element with other target tissue.

The use method is convenient to operate.

Third embodiment

The third embodiment is the most different from the above two examples in that: the energy application devices in the first two embodiments may be multiple and may be individually controlled. The energy application means of the third embodiment of my equipment may be plural or one, and if plural, may be controlled in common.

Please refer to fig. 11A and 11B, which are schematic views illustrating a structure of a third embodiment of an ablation catheter. It is used for performing ablation of target tissue, comprising:

a support shaft tube 40;

an energy application device 50, the energy application device 50 being configured to change between a delivery configuration and a deployment configuration, the energy application device 50 further comprising a driving device 51, an adjustable bracket device 52 and an energy application element 53 for applying energy to tissue, the energy application element being arranged on the bracket device 52, a first end 521 of the adjustable bracket device 52 being mounted on the support shaft tube 40, a second end 522 of the deployment configuration being freely movable under the action of the driving device 51, driving the energy application element 53 to adjust a distance and/or an angle between the energy application element and the support shaft tube 40,

an outer tube 60 configured to be relatively movable with respect to the support shaft tube, the support shaft tube being contracted between the outer tube and the support shaft tube in an inner state of the outer tube, the energy applying unit being protruded outside the outer tube in a state where a distal end of the support shaft tube is protruded outside the outer tube;

in the deployed configuration, the driving device 51 corresponding to the energy application device 50 is driven to move the second end 522 of the adjustable bracket device 52, and the distance and/or angle between the energy application element 53 and the support shaft tube 40 is adjusted to control the close contact between the energy application element 53 and the target tissue.

Only one energy application device 50 may be provided, which is very simple and practical. The same or related contents as those of the first and second embodiments will not be described again.

In this embodiment, the number of the energy application devices is at least two, and the catheter further comprises a common driving member, wherein the driving devices corresponding to the energy application devices are respectively connected to the common driving member, and the common driving member is configured to drive the driving devices to jointly act in a driving state in the unfolding configuration, so as to adjust the distance and/or the angle between the corresponding energy application element and the support shaft tube.

For example, referring to fig. 11A and 11B as an example, the common driving member includes a snap ring 71 and a snap ring triggering unit 72, the driving devices corresponding to the energy applying devices are respectively connected to the snap ring 71, the snap ring 71 is disposed between the supporting shaft tube 40 and the outer sleeve 60, the snap ring 71 is stored in the outer sleeve 60 in the delivery configuration, and the snap ring 71 triggering unit is triggered in the deployment configuration to drive the snap ring 71 to move proximally along the outer sleeve 60, so as to drive the driving devices to act together. The snap ring triggering unit may be at least two symmetrically disposed common pull wires 72, and the common pull wires 72 are designed along the pipeline direction of the supporting shaft tube.

When the driving device, the adjustable bracket device and the energy applying element are respectively a traction wire, a bracket device and an electrode unit, the bracket device further comprises a support rod and a fixing part for fixing one end of the support rod, the electrode unit is arranged at the second end of the support rod far away from the fixing part, and the traction wire is designed along the pipeline direction of the support shaft tube. In this case, the pull wires are fixed to the side of the common driving member near the proximal end and provided with corresponding transmission stoppers 73, respectively. The deployed configuration may be the only common control mode.

The unfolding configuration is also set to be an independent control mode and a common control mode, which can be selected to be a current working unfolding configuration,

wherein the independent control mode comprises: the traction wires can be independently drawn to drive the corresponding support rods to leave the support shaft tube so as to adjust the close contact degree between the support rods and the target tissue;

the common control modes include: the common driving member is configured to move downward and abut against the transmission stoppers 73 therebelow under a driving state, so as to drive the transmission stoppers 73 to move proximally at the same time, so as to drive the driving devices to act together.

The third embodiment differs from the previous embodiments in that: only one common control mode and corresponding structure can be provided, an independent control mode and a common control mode can also be provided, and one mode can be selected as the current working unfolding configuration.

The catheter is suitable for a wide range of occasions.

Fourth embodiment

The method of using the third embodiment catheter described above includes:

at least two energy applying devices are arranged, the catheter further comprises a common driving piece, the driving devices corresponding to the energy applying devices are respectively connected with the common driving piece,

in the unfolded configuration, the common driving member is configured to drive the driving devices to act together to adjust the distance and/or angle between the corresponding energy application element and the support shaft tube.

The common driving piece comprises a clamping ring and a clamping ring triggering unit, the driving devices corresponding to the energy applying devices are respectively connected with the clamping ring, the clamping ring is arranged between the supporting shaft tube and the outer sleeve, the clamping ring is stored in the outer sleeve in a conveying configuration,

in the unfolding configuration, the snap ring triggering unit is triggered to drive the snap ring to move towards the near end along the outer sleeve, so that the driving devices are driven to act together.

The driving device, the adjustable support device and the energy applying element are respectively provided with a traction wire, a support device and an electrode unit, the support device further comprises a support rod and a fixing piece for fixing one end of the support rod, the electrode unit is arranged at the second end, far away from the fixing piece, of the support rod, and the traction wire is designed along the pipeline direction of a support shaft tube;

and the traction wires are fixedly provided with corresponding transmission stoppers at one side of the common driving piece close to the near end respectively,

the independent control mode and the common control mode are set in the unfolding configuration, one mode of the independent control mode and the common control mode can be selected as the unfolding configuration which is currently operated, wherein the independent control mode comprises the following steps: the traction wires can be independently pulled to drive the corresponding support rods to leave the support shaft tube so as to adjust the close contact degree between the support rods and the target tissue; the common control modes include: the common driving piece is configured to be in a driving state, and the transmission stop blocks simultaneously move towards the near end to drive the driving devices to jointly act.

Application example one

A catheter device for intravascular treatment, comprising:

a support shaft tube having a proximal portion and a distal portion;

the deployment configuration at least comprises a plurality of energy applying devices which can be controlled independently, each energy applying device further comprises a driving device, an adjustable bracket device and an energy applying element for applying energy to tissues, the energy applying element is arranged on the bracket device, a first end of the adjustable bracket device is arranged on the supporting shaft tube, a second end of the adjustable bracket device can move freely under the action of the driving device, and the energy applying element is driven to adjust the distance and/or the angle between the energy applying element and the supporting shaft tube so as to realize the close contact of each energy applying element and tissues at preset positions in the blood vessel.

Wherein the drive arrangement, the adjustable bracket arrangement, and the energy application element are disposed along a length of the body of the support shaft tube when the carrier is configured in the delivery configuration; the energy applying elements are formed into a shape capable of encircling the supporting shaft tube.

When the carrier is configured into a conveying configuration, the energy applying devices are arranged along the outer surface of the supporting shaft tube in a staggered mode, and the shape of the energy applying devices is matched with the outer arc surface of the tube body at the installation position of the supporting shaft tube.

The catheter device is operably coupled to an energy source or an energy generator. The catheter device includes an elongated shaft having a proximal portion, a handle assembly or steering assembly for human manipulation in a proximal region of the proximal portion, and a distal portion extending distally relative to the proximal portion. The catheter device further includes an expandable carrier carrying at least one treatment assembly including a treatment member for treatment within the blood vessel. The carrier is located at or near the distal end portion of the elongate shaft.

The carrier is configured to be delivered to the vessel in a compressed (or low profile, or delivery, or reduced) configuration. The carrier in the compressed configuration can be stored within an outer sleeve. After delivery to the target site within the vessel, the carrier may be expanded into an expanded (or therapeutic, or expanded) configuration with the therapeutic member in contact with the vessel sidewall. In various embodiments, the treatment member is configured to deliver energy at the treatment site and provide a therapeutically effective electrically and/or thermally induced medical effect. In some embodiments, the carrier may be movable between the delivery and deployed configurations in the deployed configuration or arrangement via remote actuation, e.g., via an actuator or other suitable mechanism or technique (e.g., self-expanding). For example, the carrier may expand into a natural configuration without any external force being applied thereto, i.e., the carrier is neither compressed nor expanded, as well as bringing the treatment member into contact with the sidewall of the blood vessel. In some embodiments, a delivery sheath is used to deploy the carrier. The carrier is capable of self-expanding and elongating when the delivery sheath is withdrawn.

In other examples, the largest transverse dimension of the carrier is approximately or slightly smaller than the diameter of the vessel lumen, leaving room for other components that protrude outward from the carrier. The axial length of the carrier may be selected to be no longer than the target vessel of the patient. The blood vessel may compress, expand, or move in response to changes in blood flow or changes in the patient's breathing, etc. Given that a particular vessel lumen diameter may vary during carrier placement (e.g., up to 20%), the carrier may be selected for use with that vessel lumen diameter. Thus, the maximum diameter of the carrier may be sufficiently exceeded relative to the size of the vessel to allow for additional expansion during use. The stable contact with the vessel is aided by the contact force of the carrier against the vessel sidewall. Such contact forces are influenced by the material and construction of the carrier.

The treatment member may be, for example, an electrode or heating element configured to deliver energy, such as electrical energy, radio Frequency (RF) electrical energy, pulsed electrical energy, and thermal energy, to a target vessel after being advanced along a percutaneous intraluminal pathway via the catheter. For example, the energy generator can supply a continuous or pulsed RF electric field to the treatment member. While continuous delivery of RF energy is desirable, applying RF energy in the form of pulses may allow for the application of relatively high instantaneous power (e.g., higher power), longer or shorter overall duration, and/or better controlled intravascular treatment. The pulsed energy may also allow for the use of smaller treatment components. For example, the targeted application of energy to tissue by the treatment member may induce one or more desired heating effects on localized regions of the blood vessel and its adjacent regions. The heating effect can include thermal ablation as well as non-ablative thermal changes or destruction (e.g., by continuous and/or resistive heating). The desired heating effect may include raising the temperature of the target tissue above a desired threshold to achieve non-ablative thermal changes, or above a higher temperature to achieve ablative thermal changes.

When therapeutic members are employed, they may act independently, e.g., deliver power, or simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of members. In addition, the physician optionally is allowed to select which treatment member is to be used to perform a medical function, such as power delivery, to form highly customized lesions within the vessel as desired. For example, RF electric fields cause lesion formation by resistive heating of tissue exposed to the electric field. As the carrier expands, the treatment member is placed in contact with the sidewall of the blood vessel. The carrier ensures that the contact force of the treatment member does not exceed a maximum force, thereby advantageously providing a more consistent contact force.

In the state of the unfolding configuration, the electrode unit which is matched with the pre-ablated tissue in the tube cavity can be accurately controlled.

Application example two

Thromboangiitis obliterans (also known as Buerger's disease) is an acute inflammation and thrombosis (clotting) of the arteries and veins of the hands and feet. It presents recurrent acute and chronic inflammation and thrombosis of the arteries and veins of the hands and feet, the main symptom being pain at the affected site. Ulcers and gangrene of the extremities are common complications, often resulting in the need for resection procedures involving the extremities.

The exact cause of thromboangiitis obliterans/Burger's disease is not known in the prior art. It is most common in young to middle-aged men (age 20-40) who are over-smoking. Approximately 40% of patients have a history of venous inflammation (phlebitis), which may play a role in the development of Burger's disease. The disease is mainly found in the legs and also in the arms of affected patients. Early symptoms include reduced blood supply (arterial ischemia) and superficial (near skin surface) phlebitis. The main symptom is pain at the affected site. The disease occurs progressively, it first occurs in the foot or hand. Inflammation occurs in small and medium sized arteries and veins near the surface of the extremities. In advanced cases, blood vessels in other parts of the body are also affected. The blood flow at the affected site is gradually reduced. The pulse of the foot artery is weak or undetectable. Loss of blood flow can lead to gangrene due to tissue decay caused by restricted blood supply. Similar to Raynaud's disease, cold sensitivity of the hands can occur in cases where the hands turn from white to cyan to red when subjected to cold. The disease is characterized in that the chronic aseptic inflammation of the walls of small and medium arteriovenous vessels causes thickening and stenosis of the vessels, secondary thrombosis causes vessel occlusion, and ischemic symptoms appear. Unfortunately, however, there are no known effective drugs or procedures for thromboangiitis obliterans. When the disease cannot be treated, only the symptoms of the disease can be treated. The currently more effective treatment is resection of the affected site.

The main symptom of thromboangiitis obliterans is limb numbness, and the serious symptom is that tissues of the patient are necrotic and the patient is at risk of amputation. There are many causes of TAO disorders, one of which is overactivity of the vasoconstrictive nerves at the site of the lesion, causing vasoconstriction and resulting obstruction of blood flow. The catheter of the embodiment of the invention discharges through the electrode to cut off the ablation of the overactive vasomotor nerve, so that the blood vessel recovers the diastolic state and the smooth blood flow.

At present, the main treatment modes aiming at thromboangiitis obliterans comprise drug therapy, revascularization, lumbar sympathetic denervation and radiofrequency ablation, and a new treatment method is urgently needed because the drug therapy has slow effect, the revascularization method is easy to relapse, the trauma of the lumbar sympathetic denervation method is large, and the long-term prognosis is poor. The radio frequency ablation in the blood vessel is increasingly applied as a new operation, but because no special instrument exists at present, most instruments are used for super indications, and the problems of inconvenience in use and the like exist. The applicant develops a nerve ablation catheter for thromboangiitis obliterans for the first time, the catheter discharges electricity through treatment components including electrodes and the like, and the over-active vasoconstriction nerve is ablated and cut off, so that the blood vessel recovers the diastolic state and the smooth blood flow.

Namely, a nerve ablation catheter for thromboangiitis obliterans, comprising:

a support shaft tube having a proximal portion and a distal portion;

In the delivery configuration, the driving device, the adjustable stent device and the energy application elements are disposed along the length of the support shaft tube, and the energy application elements are shaped to embrace the support shaft tube for delivery of a catheter having diseased tissue with an inner diameter of less than 5 mm. When the diameter of a blood vessel possibly involved in the thromboangiitis obliterans is small, if the diameter is smaller than 5mm, the shape which can surround the supporting shaft tube can be formed by the energy applying elements, and the manufactured catheter can meet the requirement of the applicable occasion. In addition, the vessel wall in thromboangiitis obliterans is generally uneven, and the contact surface with the vessel wall using the energy application member of the catheter of this example is designed to have a structure conforming to the vessel wall. When a thrombus or the like is clogged in the vessel wall, the catheter having a small diameter can pass through a small channel clogged with the thrombus or the like relatively easily.

In addition, the number of the energy applying devices is at least two, the catheter further comprises a common driving member, the driving devices corresponding to the energy applying devices are respectively connected with the common driving member, and the common driving member drives the driving devices to jointly act under the driving state under the unfolding configuration, so as to adjust the distance and/or the angle between the corresponding energy applying element and the support shaft tube.

The working process of the energy applying device is as follows:

according to the shape and the size of the blood vessel lumen at the evaluated lesion position, the catheter is configured and conveyed to the lesion position;

pushing the support shaft tube forward or withdrawing the outer sleeve for a certain distance to expose the electrode, wherein the electrode is in a slightly expanded state;

adjusting the opening degree of the electrode through a driving device according to the shape and the size of the lumen of the blood vessel;

discharging and ablating;

according to the pathological changes and the ablation effect, after selecting a certain angle or moving a plurality of positions, the ablation is carried out again until the treatment effect is achieved, the ablation is stopped,

and (3) restoring the driving device, resetting the electrode, withdrawing the support shaft tube or pushing the outer sleeve forward when the electrode is still in a slightly expanded state, contracting the electrode into the outer sleeve, and withdrawing the catheter.

Application example three

A medical minimally invasive system comprises the catheter described above. For example, taking the application example one as an example, the medical minimally invasive system further includes: an energy source or energy generator (e.g., an RF energy generator) may be configured to generate a selected form and magnitude of energy via the treatment member for delivery to the target treatment location. The energy generator can be electrically coupled to the catheter device via a cable. A control mechanism, such as a foot pedal, may be connected (e.g., pneumatically or electrically) to the energy generator to allow the physician to initiate, terminate, and optionally adjust various operating characteristics of the energy generator, which can be configured to deliver treatment energy via an automated control algorithm and/or under the control of the physician. Further, the energy generator may include one or more evaluation or feedback algorithms to provide feedback to the physician before, during, and/or after the intravascular treatment. The generator may be part of a device or monitor which may include processing circuitry, such as a microprocessor. The therapy circuit may be configured to execute stored instructions associated with the control algorithm. The monitor may be configured to communicate with the catheter device to control power to the treatment member and/or to obtain signals from any associated sensors within or outside of the treatment member or treatment assembly. The monitor may be configured to provide an indication, such as an audible, visual, or other indication, of the power level or sensor data, or may be configured to communicate information to another device.

Under the state of the unfolding structure, the electrode unit matched with the pre-ablated tissue in the tube cavity can be accurately controlled. The location of the pre-ablated tissue within the lumen determines the position of travel of the catheter. The current shape of the tissue is pre-ablated, the distance and/or the angle of the guide wire drive which electrode unit or electrode units are controlled respectively are determined, the corresponding traction wire drive is independently controlled in the embodiment, the second end of the adjustable bracket device is driven to move, and the distance and/or the angle between the electrode unit and the supporting shaft tube are adjusted, so that the close contact between each electrode unit and the tissue in the lumen is accurately controlled.

Referring to fig. 12, the system employs the catheter shaft, control handle, first connector, cable, second connector and monitoring unit of the above example; one end of the catheter body, which is far away from the control handle, is provided with a soft section which is made of soft medical polymer material.

The embodiments of the present invention have been described in detail with reference to the drawings, but the present invention is not limited to the embodiments. Even if various changes are made to the present invention, they are still within the scope of the present invention provided that they fall within the scope of the claims of the present invention and their equivalents.

Claims

1. An ablation catheter for performing ablation of a target tissue, comprising: the method comprises the following steps:

a support shaft tube;

a plurality of individually controllable energy application devices configured to be changed between a delivery configuration and a deployment configuration, each energy application device further comprising a driving device, an adjustable stent device and an energy application element for applying energy to the tissue, the energy application element being disposed on the adjustable stent device, a first end of the adjustable stent device being mounted on the support shaft tube, a second end of the adjustable stent device being freely movable in the deployment configuration under the action of the driving device to drive the energy application element to adjust a distance and/or an angle between the energy application element and the support shaft tube, and, in the delivery configuration, the driving device, the adjustable stent device and the energy application element being disposed along a length of the support shaft tube, the energy application elements forming a shape to embrace the support shaft tube;

an outer tube configured to be relatively movable with respect to the support shaft tube, the support shaft tube being contracted between the outer tube and the support shaft tube in an inner state of the outer tube, the energy application unit being protruded outside the outer tube in a state where a distal end of the support shaft tube is protruded outside the outer tube;

in the unfolded configuration state, the driving device corresponding to the energy applying device matched with the target tissue is driven to drive the second end of the adjustable bracket device to move, and the distance and/or the angle between the energy applying elements and the supporting shaft tube are/is adjusted to realize control of close contact between each energy applying element and the target tissue.

2. The ablation catheter of claim 1, wherein the energy application elements are shaped to encircle the support shaft tube comprising: the energy applying elements are not overlapped and are respectively attached to the supporting shaft tube, so that the pipe diameter formed by the energy applying elements and the supporting shaft tube is small.

3. The ablation catheter of claim 2, wherein the energy application elements are staggered along the outer surface of the support shaft tube, the energy application elements being shaped to conform to the outer arcuate surface of the support shaft tube.

4. The ablation catheter of claim 1, further comprising the ablation catheter configured in a pre-expanded configuration: the outer sleeve is actively or passively slid in another direction to expose at least a portion of the energy application devices, the energy application elements being in a micro-expanded state.

5. The ablation catheter of claim 4, wherein the energy application elements are in a micro-expanded state further comprising: at least one part of the at least one energy applying element is spaced from the outer surface of the supporting shaft tube by an angle not less than 1 degree, so that the at least one driving device drives the adaptive energy applying element to expand.

6. The ablation catheter of claim 1, wherein the energy application devices are configured in a deployed configuration further comprising: configured in at least one of the energy application element expanded configurations.

7. The ablation catheter of claim 6, further comprising a plurality of energy application element expansion configurations configured, said ablation catheter being selectively operable in one of said energy application element expansion configurations, one of said energy application element expansion configurations corresponding to one of said plurality of energy application elements being in a same circumferential plane, two circumferential planes, and a plurality of circumferential planes.

8. The ablation catheter of claim 1, wherein the driving device, the adjustable stent device and the energy application element are a pull wire, a stent device and an electrode unit, respectively, the stent device further comprises a support rod and a fixing member for fixing one end of the support rod to the support shaft tube, the electrode unit is disposed at a second end of the support rod away from the fixing member, the pull wire is designed along the length of the support shaft tube, and the pull wire pulls the support rod away from the support shaft tube, thereby adjusting the close contact degree between the electrode unit and the intraluminal tissue.

9. The ablation catheter of claim 8, wherein said pull wire comprises a first end portion, an intermediate portion and an operating portion, said first end portion is disposed on the shaft of said support shaft near the second end thereof and below said electrode unit, said intermediate portion and said operating portion are disposed along the length of said support shaft tube body through said outer sleeve, and said intermediate portion adjusts the pulling force acting on said electrode unit through said outer sleeve as a supporting point when said operating portion is driven.

10. The ablation catheter of claim 8, further comprising an angle adjustment unit for adjusting a deflection angle of said electrode unit, said pull wire further connected to said angle adjustment unit.

11. The ablation catheter of claim 8, wherein said electrode unit and said support shaft are made of a memory material, and wherein the angle provided between said electrode unit and said support shaft is preset by the memory material.

12. The ablation catheter of claim 8, wherein the fasteners are staggered along the outer surface of the support shaft tube, and the energy application elements are shaped to conform to the outer arcuate surface of the body of the support shaft tube at the location where the support shaft tube is mounted.

13. The ablation catheter of claim 8, wherein said support shaft is shaped to conform to the outer arcuate surface of said body at the location where said support shaft tube is mounted.

14. The ablation catheter of claim 8, wherein the plurality of individually controllable energy application devices are actuated in a number of 1 or more in the deployed configuration.

15. An ablation catheter for performing ablation of a target tissue, comprising: the method comprises the following steps:

a support shaft tube;

16. The ablation catheter of claim 15, wherein there are at least two energy application devices, and further comprising a common driving member, wherein the respective driving members of the energy application devices are connected to the common driving member, and wherein the common driving member is configured to drive the driving members to move together in a driving state in the deployed configuration, so as to adjust the distance and/or angle between the respective energy application element and the support shaft tube.

17. The ablation catheter of claim 16, wherein the common drive member comprises a snap ring and a snap ring trigger unit, wherein the respective drive mechanisms of the energy application devices are connected to the snap ring, wherein the snap ring is disposed between the support shaft tube and the outer sheath, wherein the snap ring is stored in the outer sheath in the delivery configuration, and wherein the snap ring trigger unit is triggered to move the snap ring proximally along the outer sheath to thereby actuate the drive mechanisms in a common motion.

18. The ablation catheter of claim 17, wherein said snap ring trigger unit is at least two symmetrically disposed common pull wires, said common pull wires being disposed along the length of the body of the support shaft tube.

19. The ablation catheter of claim 16, wherein the driving means, the adjustable stent means and the energy application member are a pull wire, a stent means and an electrode unit, respectively, the stent means further comprising a support rod and a fixing means for fixing one end of the support rod to the support shaft tube, the electrode unit being disposed at a second end of the support rod remote from the fixing means, the pull wire being disposed along a length of the support shaft tube.

20. The ablation catheter of claim 19, wherein the pull wires are fixedly disposed with a transmission stop corresponding to the common driving member on a proximal side of the common driving member.

21. The ablation catheter of claim 20, wherein the deployed configuration is configured in an independent control mode and a common control mode, selectable in one of the modes being a currently operative deployed configuration,

the common control modes include: the common driving piece is configured to be in a driving state, and the transmission stop blocks simultaneously move towards the near end to drive the driving devices to jointly act.

22. The ablation catheter of claim 15, wherein in the delivery configuration, the drive mechanism, adjustable stent mechanism, and energy application elements are disposed along the length of the support shaft, the energy application elements being shaped to encircle the support shaft.

23. The ablation catheter of claim 15, wherein the energy application elements are staggered along the outer surface of the support shaft tube and are shaped to conform to the outer arcuate surface of the support shaft tube.

24. The ablation catheter of claim 15, further comprising the catheter in a pre-expanded configuration: the outer sleeve is actively or passively slid in another direction to expose at least a portion of the energy application devices, the energy application elements being in a micro-expanded state.

25. A catheter device for intravascular treatment, comprising:

a support shaft tube having a proximal portion and a distal portion;

a carrier carrying at least one therapeutic component, wherein the carrier is located at or near the distal end portion of the support shaft tube, an

Wherein the treatment assembly comprises at least one treatment member for intravascular treatment; wherein the carrier is configured to change between a delivery configuration and a deployed configuration; the distal end portion of the support shaft tube is configured for intravascular delivery of the carrier,

the unfolding configuration at least comprises at least one energy applying device, each energy applying device further comprises a driving device, an adjustable bracket device and an energy applying element for applying energy to the target tissue, the energy applying element is arranged on the bracket device, the first end of the adjustable bracket device is arranged on the supporting shaft tube, the second end of the adjustable bracket device can freely move under the action of the driving device, and the energy applying element is driven to adjust the distance and/or the angle between the energy applying element and the supporting shaft tube so as to realize the control of the close contact of the energy applying element and the target tissue in the blood vessel.

26. The catheter device for endovascular treatment of claim 25, wherein the drive arrangement, adjustable stent arrangement and energy application element are disposed along a length of the body of the support shaft tube when the carrier is configured in a delivery configuration; the energy applying elements are formed in a shape to embrace the support shaft tube.

27. The catheter apparatus for endovascular therapy of claim 25, wherein the energy application devices are staggered along the outer surface of the support shaft tube when the carrier is configured in the delivery configuration to conform to the extrados of the body at the location where the support shaft tube is mounted.

28. A nerve ablation catheter for thromboangiitis obliterans, comprising:

a support shaft tube having a proximal portion and a distal portion;

a carrier carrying at least one therapeutic component, wherein the carrier is located at or near a distal portion of the support shaft tube, an

the unfolding configuration at least comprises at least one energy applying device, each energy applying device further comprises a driving device, an adjustable bracket device and an energy applying element for applying energy to the target tissue, the energy applying element is arranged on the bracket device, the first end of the adjustable bracket device is arranged on the supporting shaft tube, the second end of the adjustable bracket device can move freely under the action of the driving device, the energy applying element is driven to adjust the distance and/or the angle between the energy applying element and the supporting shaft tube so as to realize the control of the close contact of the energy applying element and the target tissue in the blood vessel, and the energy applying element is applied with energy so as to inactivate the accessory nerve on the inner wall of the blood vessel at high temperature.

29. The nerve ablation catheter for thromboangiitis obliterans according to claim 28,

in the delivery configuration, the driving device, the adjustable stent device and the energy applying elements are arranged along the length direction of the support shaft tube, and the energy applying elements are formed into a shape capable of encircling the support shaft tube so as to be suitable for catheter delivery of lesion tissues with the inner diameter of the lumen part being less than 5 mm.

30. The nerve ablation catheter for thromboangiitis obliterans according to claim 28,

at least two energy applying devices are arranged, the ablation catheter further comprises a common driving piece, the driving devices corresponding to the energy applying devices are respectively connected with the common driving piece,

in the unfolded configuration, the common driving member is configured to drive the driving devices to act together to adjust the distance and/or angle between the energy application element and the support shaft tube.

31. A medical minimally invasive system comprising an ablation catheter according to any one of claims 15 to 24.