CN107595382B

CN107595382B - Spiral radiofrequency ablation catheter with adherent adjusting wire and equipment thereof

Info

Publication number: CN107595382B
Application number: CN201710937875.8A
Authority: CN
Inventors: 董永华; 沈美君
Original assignee: Shanghai Golden Leaf Medtech Co ltd
Current assignee: Shanghai Golden Leaf Medtech Co ltd
Priority date: 2015-03-23
Filing date: 2015-06-19
Publication date: 2020-09-01
Anticipated expiration: 2035-06-19
Also published as: CN104939918A; CN204734547U; CN107595382A; CN107569283A; CN107569283B; CN104939918B; CN104688334A

Abstract

The invention provides a spiral radio frequency ablation catheter with an adherence adjusting wire, which is provided with a long strip-shaped catheter tube body, wherein the front end of the catheter tube body is provided with a spiral electrode bracket, the electrode bracket is provided with one or more electrodes, and the rear end of the catheter tube body is provided with a control handle; the rear section of the adherence adjusting wire can be slidably arranged in one of the tube cavities of the catheter tube body, and the rear end of the adherence adjusting wire is connected to a control piece arranged on the control handle or connected to an external control piece after penetrating through the control handle; the front section of the adherence adjusting wire penetrates out of the electrode bracket and then is exposed outside the electrode bracket, and the front end of the adherence adjusting wire returns to the inside of the electrode bracket and is fixed. The diameter of the spiral shape of the electrode bracket can be greatly changed by pulling the adherence adjusting wire backwards, so that the spiral radiofrequency ablation catheter is suitable for target lumens with different diameters, and the adherence state of the electrode on the electrode bracket is good.

Description

Spiral radiofrequency ablation catheter with adherent adjusting wire and equipment thereof

The application is named as: the spiral radiofrequency ablation catheter with the adherent adjusting wire and the equipment thereof have the following application numbers: 201210350172.6, the filing date of the parent application is 2015, 06 and 19.

Technical Field

The invention relates to a spiral radiofrequency ablation catheter with an adherence adjusting wire, and simultaneously relates to radiofrequency ablation equipment comprising the radiofrequency ablation catheter, belonging to the technical field of interventional medical instruments.

Background

In the radio frequency ablation system, a radio frequency ablation catheter is a key device for intervening in a human blood vessel and performing radio frequency energy release. The radio frequency electrode is arranged on a bracket at the front end of the radio frequency ablation catheter, the bracket is used for bearing the radio frequency electrode, expanding the adherent wall before the radio frequency starts, and contracting and withdrawing after the radio frequency is finished. Because the radiofrequency ablation operation is directly conducted in the human blood vessel, the telescopic size of the stent is matched with the diameter of the human blood vessel.

The diameter of blood vessels in the human body varies depending on the ablation site. Meanwhile, the diameter of the blood vessel of the human body is different from person to person, for example, the diameter of the renal artery of different human bodies is about 2-12 mm, and the difference is large. In the prior art, the telescopic size of an electrode end of a radio frequency ablation catheter is generally fixed, the requirement of the diameter size of different human blood vessels cannot be met, and the coverage of the human blood vessels with different diameters is narrow. Therefore, when the radiofrequency ablation operation is performed on different patients, the radiofrequency ablation catheter with different specifications and models needs to be replaced for ablation. Even so, still can appear in some cases when the operation, the radio frequency electrode can't adhere to the wall problem simultaneously, influences the operation effect.

The structure of the radiofrequency ablation catheter is divided into a plurality of types according to the shapes of the electrodes and the electrode supports, such as: balloon type, puncture needle type, spiral type, flap-like structure, and the like. Among them, the radio frequency ablation catheter in which the electrode holder is designed as a spiral type is widely used. The conventional helical rf ablation catheter is mainly configured by shaping an electrode holder in advance, then entering the inside of a blood vessel with the aid of a guide catheter/sheath (e.g., a sheath disclosed in chinese utility model patent ZL200920172984.6 and a guide catheter disclosed in chinese invention application CN 201210480777.3), and moving the rf ablation catheter out of the sheath/guide catheter by advancing the rf ablation catheter or by moving the guide catheter/sheath backward, so that the electrode holder is restored to a shaped shape after entering a target position. Because the electrode support is fixed in size by pre-shaping for a single radiofrequency ablation catheter, the adaptability of the existing spiral radiofrequency ablation catheter to blood vessels with different diameters has limitation.

Disclosure of Invention

The invention aims to solve the primary technical problem of providing a spiral radio frequency ablation catheter with an adherence adjusting wire.

Another technical problem to be solved by the present invention is to provide a radiofrequency ablation device comprising the above radiofrequency ablation catheter.

In order to achieve the purpose, the invention adopts the following technical scheme:

a spiral radio frequency ablation catheter with an adherence adjusting wire is provided with a long-strip-shaped catheter tube body, wherein a spiral electrode support is arranged at the front end of the catheter tube body, one or more electrodes are arranged on the electrode support, and a control handle is arranged at the rear end of the catheter tube body; wherein the content of the first and second substances,

the rear section of the adherence adjusting wire is slidably arranged in one of the tube cavities of the catheter tube body, and the rear end of the adherence adjusting wire is connected to a control piece arranged on the control handle or connected to an external control piece after penetrating through the control handle; the front section of the adherence adjusting wire penetrates out of the electrode support and is exposed outside the electrode support, and the front end of the adherence adjusting wire returns to the inside of the electrode support and is fixed.

Preferably, after the front end of the adherence adjusting wire returns to the inside of the electrode bracket, the front end of the adherence adjusting wire returns to the rear end of the catheter tube through the electrode bracket and the lumen inside the catheter tube and is fixed on the control handle or the control piece.

Or, preferably, the front end of the adherence adjusting wire is fixed at the front end of the electrode bracket after returning to the inside of the electrode bracket.

Or, preferably, the front end of the adherence adjusting wire is fixed or limited outside after returning to the inside of the electrode bracket; the anchorage-regulating filaments are simultaneously supporting filaments.

Or, preferably, the device further comprises a supporting wire fixedly arranged in a certain lumen of the connecting catheter and the electrode stent, and the front end of the adherence adjusting wire is fixed on the supporting wire; or the adherence adjusting wire is a thin wire which is divided outwards from the supporting wire.

Preferably, the part of the supporting wire inside the electrode bracket is shaped into a spiral to form a spiral shaped section.

Or, preferably, a fixing point exists between the part of the adherence adjusting wire exposed outside the electrode support and the electrode support, and the front end and the rear end of the adherence adjusting wire respectively penetrate out of the rear end of the catheter tube body and are fixed on the corresponding control piece arranged on the control handle, or penetrate through the control handle and then are connected to the corresponding control piece arranged outside.

Preferably, the anchorage regulating wires are fixed in the holes of a spiral section of the electrode support at a point exposed outside the electrode support.

Or, wherein preferably, the adherence adjusting wire comprises a plurality of wires, wherein the front end of each wire is fixed on the electrode support, the rear end of each wire externally bypasses a section of spiral section of the electrode support and enters the electrode support or the catheter tube body, then the wires penetrate out from the tail end of the catheter tube body through the lumen of the catheter tube body and are fixed on the corresponding control piece arranged on the control handle, or the wires penetrate through the control handle and are fixed on the corresponding control piece arranged outside, and the plurality of wires are respectively used for independently controlling the diameters of different spiral sections of the electrode support.

Preferably, the fixation points of the plurality of filaments on the electrode support are different from one another.

Preferably, two of the plurality of wires have a common fastening point on the electrode carrier.

Wherein preferably each strand enters the interior of the electrode holder from a different position on the electrode holder.

Or, wherein preferably the fixation points of the plurality of filaments to the electrode support are the same.

A radio frequency ablation device comprises the radio frequency ablation catheter and a radio frequency ablation host connected with the radio frequency ablation catheter.

The spiral radiofrequency ablation catheter with the adherence adjusting wire has good adaptability to target lumens with different diameters. In target lumens with different diameters, the adherence state of the electrode arranged on the electrode bracket can be good by pulling the adherence adjusting wire. In addition, the adherence adjusting wire can also adopt a multi-strand wire structure, and the individual control of different spiral sections of the radiofrequency ablation catheter can be realized by individually controlling the single wires, so that the diameter adjusting difficulty of the electrode bracket is simplified.

Drawings

FIG. 1 is a schematic structural diagram of an electrode holder and a catheter tube in a first helical RF ablation catheter provided by the present invention;

FIG. 2 is a schematic cross-sectional view of an electrode holder of the helical RF ablation catheter of FIG. 1;

FIG. 3 is a schematic cross-sectional view A-A of the helical RF ablation catheter of FIG. 2;

FIG. 3A is an enlarged schematic view of section I of the helical RF ablation catheter of FIG. 3;

FIG. 4 is a schematic view showing another arrangement of the adherence adjusting wire in the first embodiment;

FIG. 5 is a schematic structural view of a control handle of a first helical RF ablation catheter according to the present invention;

FIG. 6A is a schematic view of the helical RF ablation catheter of FIG. 1 in an initial state;

FIG. 6B is a schematic side view of the helical RF ablation catheter of FIG. 6A;

FIG. 7 is a schematic view of the helical RF ablation catheter of FIG. 1 in a sheath;

FIG. 8 is a schematic view of the helical RF ablation catheter of FIG. 1 in use in a thinner vessel;

FIG. 9A is a schematic view of the helical RF ablation catheter of FIG. 1 in use in a thicker vessel;

FIG. 9B is a schematic side view of the helical RF ablation catheter of FIG. 9A;

FIG. 10 is a schematic structural view of an electrode holder and a catheter shaft of a second helical RF ablation catheter;

FIG. 11 is a schematic view of the helical RF ablation catheter of FIG. 10 in use;

FIG. 12A is a schematic view of a control handle of a second helical RF ablation catheter in use;

FIG. 12B is a schematic view of a control handle of the second helical RF ablation catheter in a further use configuration;

FIG. 13 is a schematic structural view of an electrode holder and a catheter shaft of a third helical RF ablation catheter;

FIG. 14 is a schematic structural view of a support wire in a third helical RF ablation catheter;

FIG. 15 is a schematic structural view of an electrode holder and a catheter shaft of a fourth helical RF ablation catheter;

fig. 16 is a schematic structural diagram of a supporting wire and an adherence adjusting wire in a fourth helical rf ablation catheter;

FIG. 17A is a schematic structural view of an electrode holder and a catheter shaft of a fifth helical RF ablation catheter;

FIG. 17B is a schematic side view of the helical RF ablation catheter of FIG. 17A;

FIG. 18A is a schematic structural view of an electrode holder and a catheter shaft of a sixth helical RF ablation catheter;

FIG. 18B is a schematic side view of the helical RF ablation catheter of FIG. 18A;

FIG. 19 is a schematic view of the internal structure of an electrode holder in a sixth helical RF ablation catheter;

fig. 20A is a schematic diagram showing the state of the electrode stent after adherence in the sixth helical rf ablation catheter with the adherence adjusting wire pulled back;

FIG. 20B is a schematic side view of the helical RF ablation catheter of FIG. 20A;

FIG. 21 is a schematic view of the structure of the adherent adjustment wires in the seventh helical RF ablation catheter;

FIG. 22A is a schematic view of another configuration of the adherent adjustment wires in the seventh helical RF ablation catheter;

fig. 22B is a schematic view of another structure of the adherence adjusting wire in the seventh helical rf ablation catheter.

Detailed Description

The technical contents of the present invention are further described in detail below with reference to the accompanying drawings and specific embodiments.

First embodiment

As can be seen from fig. 1 to 5, the helical rf ablation catheter provided by the present invention includes a long-strip-shaped catheter tube, a helical electrode holder disposed at the front end of the catheter tube, and a control handle 20 disposed at the rear end of the catheter tube (see fig. 5). In actual manufacturing, the electrode support and the catheter tube body can be manufactured integrally, and the electrode support is a spiral part shaped at the front end of the catheter tube body; the electrode bracket can also be manufactured independently and then connected with the catheter body into a whole.

As shown in fig. 1, the spiral-shaped electrode stent includes an outer tube 1 and one or more electrodes 2 disposed on the outer tube 1. The electrode 2 may be a block electrode or a ring electrode embedded on the outer circumference of the outer tube 1, the upper surface of the electrode 2 may be flush with the outer surface of the outer tube 1 or slightly higher than the outer surface of the outer tube 1, and the upper surface of the electrode 2 may also be lower than the outer surface of the outer tube 1. The plurality of electrodes 2 are uniformly or unevenly distributed on the spiral shape of the electrode support in the circumferential direction, and the plurality of electrodes can be distributed on the electrode support in 1 circle, more than 1 circle or less than 1 circle.

The outer tube 1 of the electrode stent can be a single-lumen tube or a multi-lumen tube, and the outer tube 1 can be made of a polymer material or a metal material, such as stainless steel or a memory alloy. The outer pipe 1 can be made of straight pipes and bars, and also can be made into a spiral special-shaped pipe by using the section A. As shown in fig. 2 and fig. 3A, when the outer tube 1 is a multi-lumen tube, a plurality of lumens are further provided inside the outer tube 1 of the electrode stent except for a central lumen, a group of radio frequency wires 3 and thermocouple wires 4 are respectively provided in a part of the lumens, and the head ends of each group of radio frequency wires 3 and thermocouple wires 4 are provided inside a single electrode 2, wherein the head end of the radio frequency wire 3 is tightly fixed to the electrode 2, and the connection is achieved by using welding, conductive adhesive bonding and other processes; the head ends of the two thermocouple wires 4 are welded and coated by the thermocouple wire head end insulating layer 5, and then are arranged in an insulating way with the radio frequency wire 3 and the electrode 2.

As shown in fig. 2, a spiral shaped wire 6 is further disposed in one of the lumens of the outer tube 1, and the spiral shaped wire 6 is fixed in the spiral deformation region section for supporting the spiral shape of the electrode stent. Of course, the electrode support can also be directly shaped into a spiral shape, so that the spiral shaping wire 6 is omitted, for example, when the outer tube is made of memory alloy or high polymer material, the spiral shaping wire 6 can be omitted.

As shown in fig. 3, a support wire 7 is disposed in the central lumen inside the catheter shaft and the electrode stent, the support wire 7 may be movably disposed in the central lumen, or may be fixedly disposed in the central lumen, or the support wire 7 may be disposed in other lumens of the catheter shaft and the electrode stent. The head end of the supporting wire 7 can be provided with a developing head for instant imaging of the inside of the target lumen. Meanwhile, the front end of the supporting wire 7 can be provided with a soft guide wire 9, the soft guide wire 9 can be a straight head soft guide wire or an elbow soft guide wire shown in the figure, so that the radiofrequency ablation catheter can omit a guide catheter/sheath tube and directly enter a blood vessel, and the operation is simplified.

As can be seen from fig. 1 to 5, a lumen for accommodating the anchorage wall adjusting wire 8 is further provided inside the catheter tube, the rear section of the anchorage wall adjusting wire 8 is slidably disposed in one of the lumens of the catheter tube, and the rear end 80 of the anchorage wall adjusting wire passes through the catheter tube, penetrates into the control handle 20, passes through the control handle 20, and is connected to the external control member 22 (see fig. 5). The adherent adjustment wires 8 can slide back and forth within the lumen of the catheter shaft. The lumen for receiving the adherence adjusting wire 8 may be a central lumen or one of a plurality of eccentric lumens distributed at the periphery of the central lumen. As shown in figure 1, the front section of the adherence adjusting wire 8 passes through the outside of the electrode bracket from a hole 12 close to the rear end of the electrode bracket, is exposed outside the electrode bracket, and the front end of the adherence adjusting wire returns to the inside of the electrode bracket from a hole 11 close to the front end of the electrode bracket and is fixed.

The fixed position of the front end of the adherence adjusting wire 8 can be different, and can be fixed at the front end of the electrode bracket, also can be fixed at the front end of the supporting wire 7, and also can be fixed on the spiral shaping wire 6, or can also pass through the corresponding lumens inside the electrode bracket and the catheter tube body to return to the rear end of the catheter tube body, and is fixed on the control part 22 together with the rear end of the adherence adjusting wire 8.

Specifically, in the structure shown in fig. 3, the front end of the adherence adjusting wire 8 returns to the inside of the electrode holder from the hole 11 near the front end of the electrode holder, passes through the lumens inside the electrode holder and the catheter tube, and returns to the rear end of the catheter tube together with the rear end of the adherence adjusting wire 8, and then the front end and the rear end of the adherence adjusting wire 8 may be fixed to the same control member 22 as shown in fig. 5, or the front end and the rear end of the adherence adjusting wire 8, one of which is fixed to the housing of the control handle 20 and the other of which is fixed to the control member 22. By pulling the control member 22, the diameter of the helical section of the electrode holder can be changed.

Of course, the front end of the adherence adjusting wire 8 can also be simply fixed at the front end of the electrode support, or fixed at the front end of the supporting wire 7 or a certain part of the supporting wire 7 inside the electrode support, or fixed at a certain part on the spiral shaping wire 6, or fixed in the lumen of the electrode support, as long as the front end is fixed. Therefore, when the wall-adhering adjusting wire 8 is pulled from the rear end, the electrode support can contract and deform under the action of the wall-adhering adjusting wire 8, the spiral diameter of the electrode support is increased, and the axial intervals of the spiral shapes contract. When the front end of the adherence adjusting wire 8 is fixed on the supporting wire 7 or the spiral shaping wire 6, the adherence adjusting wire 8 and the supporting wire 7/the spiral shaping wire 6 can be made of the same material, and at the moment, the adherence adjusting wire 8 can be a filament separated from the supporting wire 7/the spiral shaping wire 6 backwards.

For example, in the structure shown in fig. 4, the front end of the adherence adjusting wire 8 is fixed with the front end of the spiral shaping wire 6, in this case, the spiral shaping wire 6 and the adherence adjusting wire 8 can be made of the same filament, and the adherence adjusting wire 8 and the spiral shaping wire 6 are two filament branches with the front ends thereof being divided backwards respectively, wherein the branch corresponding to the spiral shaping wire 6 is fixed in a certain lumen of the electrode stent, and the rear section of the branch corresponding to the adherence adjusting wire 8 can slide in the lumen of the electrode stent and/or the catheter tube body. When the adherence adjusting wire 8 and the spiral shaping wire 6 are made of different materials (for example, the spiral shaping wire 6 uses a pipe, and the adherence adjusting wire 8 uses a filament), the front end/front section of the adherence adjusting wire 8 and the spiral shaping wire 6 can be assembled together in a welding, riveting, bonding and other modes.

In addition, as can be seen from fig. 5, in the above structure, the button controller 21 is further provided on the control handle 20, and the end 70 of the support wire 7 passes through the catheter shaft, enters the control handle 20, and is fixed to the button controller 21. The control member for connection to the distal end of the support wire 7 may be provided on the outside of the control handle 20 as the control member 22, in addition to being provided on the control handle 20 as shown in the drawing, and similarly, the control member for connection to the adherence adjusting wire 8 may be provided on the control handle 20 as the push button control member 21.

Fig. 6A-9B are schematic views showing the use of the helical rf ablation catheter in lumens with different diameters according to the first embodiment of the present invention. As shown in fig. 6A and 6B, a radiofrequency ablation catheter with an initial diameter Φ B of 10mm and an axial distance a between the head and tail electrodes is taken as an example. When it enters the phi 2mm sheath, the electrode stent is approximately linear in shape as shown in fig. 7. When the electrode stent extends out of the sheath tube and enters a vessel with the diameter of phi 4mm, the spiral diameter phi B-3 of the electrode stent is limited by the vessel diameter to be about 4mm, at the moment, the electrodes are in close contact with the vessel wall under the natural expansion action of the electrode stent, and the axial distance (A-3) > A between the head electrode and the tail electrode (see figure 8). As shown in fig. 9A and 9B, when it extends from the sheath into the vessel with a diameter of 12mm, after the electrode stent is naturally expanded, the electrode 2 cannot adhere to the wall because its initial diameter Φ B is smaller than the diameter of the target lumen, at this time, by pulling the adherence adjusting wire 8 backwards, the spiral diameter of the electrode stent can be increased to Φ B-4, which is equal to the diameter of the target lumen, and the plurality of electrodes 2 are in close contact with the vessel wall under the action of the adherence adjusting wire 8. At the moment, the axial distance between the head electrode and the tail electrode is reduced to A-4, the axial distance between the electrodes is reduced, but the ablation effect of the electrodes can be prevented from influencing each other due to the larger diameter of the target lumen, and thus excessive ablation cannot be caused. Moreover, as can be seen from the side views shown in fig. 6B and fig. 9B, the axial distance between the electrodes 2 uniformly distributed on the spiral shape of the electrode stent is reduced under the action of the adherence adjusting wire 8, and the spiral distance is not changed.

Fig. 6A to 9B illustrate an electrode holder with Φ B of 10 mm. When the initial diameter of the spiral shape of the electrode stent is other values (for example, 6mm, 8mm), similarly, when it enters a thinner blood vessel, the plurality of electrodes can adhere well at the same time under the effect of natural expansion of the spiral electrode stent, and when it enters a target lumen with a diameter larger than the initial diameter of the spiral shape, as shown in fig. 9A and 9B, by pulling the adherence adjusting wire, the plurality of electrodes can also be brought into close contact with the vessel wall at the same time, and the adherence state is good.

Second embodiment

The radio frequency ablation catheter shown in fig. 10 is similar in construction to the radio frequency ablation catheter of the first embodiment, with reference to fig. 11 in its collapsed state. Fig. 12A and 12B are schematic views of the control handle 20 of the rf ablation catheter in different states of use, respectively.

Specifically, a spiral sizing wire 6 is disposed within the electrode stent, and a support wire 7 is disposed within the catheter shaft and the electrode stent. Wherein, the part of the supporting wire 7 corresponding to the electrode bracket is exposed outside the electrode bracket, the part of the supporting wire 7 corresponding to the catheter tube body is arranged in a certain tube cavity of the catheter tube body, and the rear end of the supporting wire is fixed on a control piece 25 arranged on the control handle 20 after penetrating out of the catheter tube body. The spiral shape of the electrode bracket can be changed by pulling the supporting wire 7, and the supporting wire 7 has the function of an adherence adjusting wire 8. In other words, the rear section of the adherence adjusting wire 8 is slidably disposed in a certain lumen of the catheter tube body, and the rear end thereof is connected to the control handle 20; the front section of the adherence adjusting wire 8 passes through the hole 12 and is exposed outside the electrode bracket, and the front end thereof passes through the hole 11 and is fixed or limited outside after returning to the inside of the electrode bracket; the anchorage-regulating wire 8 is at the same time a support wire for the catheter shaft. A developing head and/or a soft guide wire 9 can be arranged at the front end of the adherence adjusting wire 8.

As shown in fig. 12A and 12B, in this embodiment, only one control member 25 connected to the support wire 7 may be disposed on the control handle 20, and in this case, the control member 25 is used to adjust the telescopic state of the electrode holder. By pushing the control member 25 back from the position shown in fig. 12A to the position shown in fig. 12B, the support wire 7, i.e. the anchorage regulating wire 8, can be pulled back, increasing the helical diameter of the electrode holder.

Third embodiment

The radio frequency ablation catheter shown in fig. 13 is similar in structure to the radio frequency ablation catheter of the first embodiment, and fig. 14 shows the structure of the support wire 7 of the radio frequency ablation catheter in the third embodiment.

In this embodiment, the structure of the adherence adjusting wire 8 is the same as that of the first embodiment. The rear section of the adherence adjusting wire 8 can be slidably arranged in a certain tube cavity of the catheter tube body, and the rear end of the adherence adjusting wire is connected to a control part 22 arranged on the control handle 20 or connected to an external control part 22 after penetrating out of the control handle 20; the front section of the wall-adhering adjusting wire 8 penetrates out of the electrode bracket from the hole 12 and is exposed outside the electrode bracket, and the front end of the wall-adhering adjusting wire returns to the inside of the electrode bracket from the hole 11 and can be fixed at the front end of the electrode bracket or the front end of the supporting wire 7, or can pass through corresponding lumens inside the electrode bracket and the catheter tube and return to the rear end of the catheter tube, and is fixed on the shell of the control handle 20 or the control part 22 together with the rear end of the wall-adhering adjusting wire 8. By pulling the control member 22, the diameter of the helical section of the electrode holder can be changed.

In this embodiment, the spiral shaping wire is not separately provided, wherein, as shown in fig. 14, the portion of the front portion of the support wire 7 corresponding to the electrode holder is shaped into a spiral shape by pre-shaping, constituting the spiral shaping section 76. The supporting wire 7 is fixedly arranged in a certain lumen of the electrode bracket and the catheter body, so that the corresponding part of the electrode bracket can obtain a spiral shape.

In the first and third embodiments, the adherence adjusting wire 8 may be provided in the same lumen of the catheter tube together with the support wire 7, or may be provided separately in a single lumen of the catheter tube.

Fourth embodiment

The structure of the radiofrequency ablation catheter shown in fig. 15 is similar to that of the radiofrequency ablation catheter of the first embodiment, and fig. 16 shows the structure of the supporting wire 7 and the adherence adjusting wire 8 of the radiofrequency ablation catheter of the fourth embodiment, wherein the supporting wire 7, the adherence adjusting wire 8 and the spiral shaping wire 6 are integrally arranged.

In this embodiment, the support wire 7 is disposed inside the catheter shaft and the electrode stent, and the helical shaping wire is not separately disposed inside the electrode stent. As shown in fig. 16, the front portion of the support wire 7 corresponding to the electrode holder is shaped into a spiral shape by a pre-shaping, thereby forming a spiral shaped section 76.

The adherence adjusting wire 8 and the supporting wire 7 are integrally arranged, the front end of the adherence adjusting wire 8 is fixed on the supporting wire 7, or the adherence adjusting wire 8 is a thin wire which is separated from the supporting wire 7. The front section of the wall-adhering adjusting wire 8 passes out of the electrode bracket from the hole 11 and is exposed outside the electrode bracket, and returns to the inside of the electrode bracket/catheter tube from the hole 12, and then the rear section thereof slidably passes through a certain tube cavity inside the catheter tube and returns to the rear end of the catheter tube to be fixed on the control part 22. By pulling the control member 22, the diameter of the helical section of the electrode holder can be changed.

In this embodiment, the rear section of the adherence adjusting wire 8 may be disposed in a certain lumen of the catheter tube together with the support wire 7, or may be independently disposed in another lumen of the catheter tube.

Fifth embodiment

Fig. 17A and 17B are schematic structural views of a radio frequency ablation catheter in a fifth embodiment.

As shown in fig. 6B and 9B, in the first to fourth embodiments, even if the adherence adjusting wire 8 is disposed in the eccentric lumen of the catheter shaft, the portion exposed outside the electrode stent is still located near the center position of the spiral shape of the electrode stent. When the adherence adjusting wire 8 is pulled backwards, the electrode bracket contracts axially, and the adherence adjusting wire 8 penetrates through the center of the spiral shape; when the spiral shape of the electrode stent is elongated to be approximately linear, the part of the adherence adjusting wire 8 exposed out of the electrode stent is approximately parallel to the outer tube 1 of the electrode stent.

Unlike the four embodiments described above, in the fifth embodiment, the adherence adjusting wire 8 is not disposed near the center position of the spiral shape of the electrode holder, but is disposed eccentrically at the outer circumferential position of the spiral shape. As shown in fig. 17A and 17B, when the anchorage-regulating wire 8 is eccentrically disposed at the outer circumferential position of the spiral shape of the electrode holder, the portion of the anchorage-regulating wire 8 exposed to the outside of the electrode holder does not pass through the inside of the spiral shape, but bypasses one side of the outside of the spiral shape. When the adherence adjusting wire 8 is pulled backwards, one or more circles of spiral sections between the two

holes

11 and 12 of the electrode bracket shrink and deform to become a new spiral shape, so that the existing diameter of the spiral shape is increased, and the diameter expansion is realized.

Through the arrangement mode, the diameter of the contracted spiral shape can be greatly increased, and the electrode stent can be applied to blood vessels with the diameter larger than the diameter of a single spiral section of the electrode stent under ideal conditions. The diameter range of the human blood vessel is fixed, so that the spiral initial diameter of the electrode support in the radiofrequency ablation catheter can be greatly reduced, and the radiofrequency ablation catheter can conveniently enter the blood vessel and move in the blood vessel.

Sixth embodiment

Fig. 18A to 20B are schematic structural views of a radio frequency ablation catheter in a sixth embodiment provided by the present invention, wherein a fixing point exists between a portion of the adherence adjusting wire 8 exposed outside the electrode holder and the electrode holder, and both the front end and the rear end of the adherence adjusting wire 8 penetrate out of the rear end of the catheter tube and are fixed on a control member disposed on the control handle 20 or externally disposed on a corresponding control member outside the control handle 20.

As shown in fig. 18A and 18B, when the anchorage regulating wires 8 are not tensioned, the portions of the anchorage regulating wires 8 exposed outside the electrode holder are relaxed. The anchorage-dependent adjusting wire 8 is fixed to a spiral section of the electrode holder at a point exposed outside the electrode holder, which may be fixed directly to the outer tube or to a hole provided in the outer tube. In order to keep the smooth outer wall of the electrode holder and to avoid scratching the target lumen by the fixation point, it is recommended to place the fixation point in the hole of the outer tube 1.

Specifically, as shown in fig. 19, in this embodiment, there is a fixed point 13 in the middle of the anchorage regulating wire 8 and the electrode holder, and the front section 81 of the anchorage regulating wire 8 goes forward from the fixed point 13, passes around the outside of the electrode holder, returns to the inside of the electrode holder from the hole 11 near the front end of the electrode holder, and returns to the control handle 20 via the lumen inside the electrode holder and the catheter shaft; the rear section 82 of the anchorage wires 8 passes from the fixation point 13 back around the outside of the electrode holder and back into the inside of the electrode holder from the hole 12 near the rear end of the electrode holder and back into the control handle 20 via the lumen inside the electrode holder and catheter shaft. The anterior segment 81 and the posterior segment 82 of the anchorage-regulating wire 8 may be returned to the control handle 20 via the same lumen in the electrode holder and catheter shaft, or may each be returned to the control handle 20 via different lumens as shown in fig. 19. A control member can be arranged on the control handle 20 for fixing the tail end of the front section 81 and the tail end of the rear section 82 of the adherence adjusting wire 8, and two control members can be arranged for respectively fixing the tail end of the front section 81 and the tail end of the rear section 82 of the adherence adjusting wire 8, so that the front section 81 and the rear section 82 of the adherence adjusting wire 8 are respectively controlled.

The front section 81 of the anchorage-regulating wire 8 is used for controlling the diameter expansion of the spiral section of the electrode support between the hole 11 and the fixing point 13, and the rear section 82 of the anchorage-regulating wire 8 is used for controlling the diameter expansion of the spiral section of the electrode support between the hole 12 and the fixing point 13. As shown in fig. 20A and 20B, when the rear section 82 of the adherence adjusting wire 8 is tightened, the fixing point 13 approaches to the hole 12 of the electrode stent, the diameter of the 1-turn spiral section between the two is continuously close to the initial diameter Φ B of the spiral of the electrode stent, so that better adherence effect is obtained, while the spiral section with more than 1 turn is deformed into a new spiral shape, the diameter of which exceeds the initial diameter Φ B of the spiral of the electrode stent, so that the diameter is expanded. Similarly, when the front section 81 of the adherence adjusting wire 8 is tensioned, the hole 11 of the electrode bracket is close to the fixing point 13, the diameter of the 1-turn spiral section between the two is continuously close to the initial diameter phi B of the spiral of the electrode bracket, so that a better adherence effect is obtained, the spiral section more than 1 turn is deformed into a new spiral, the diameter of the spiral section is also larger than the initial diameter phi B of the spiral of the electrode bracket, and the diameter is expanded, so that a larger adherence diameter and a better adherence effect are obtained.

The control of the front section 81 and the rear section 82 of the adherence adjusting wire can be respectively controlled by two single control pieces correspondingly connected with the front section 81 and the rear section 82, so that the independent adjustment of the diameters of different parts on the electrode support is realized, and the control of the diameter expansion of the whole spiral sections of the electrode support is also realized by the control piece. Moreover, when the tail end of the front section 81 and the tail end of the rear section 82 of the adherence adjusting wire are respectively fixed on different control members, different parts of the electrode support can be simultaneously deformed by pulling the front section 81 and the rear section 82 of the adherence adjusting wire simultaneously, so that the diameter of the whole electrode support is adjusted, the axial contraction effect as shown in fig. 20A is achieved, and the spiral diameter after the diameter is expanded can achieve the effect as shown in fig. 20B. Since the front section 81 and the rear section 82 of the anchorage-regulating wire 8 can control the diameter expansion of the one or more turns of the helical section of the electrode holder between the hole 12 and the fixation point 13, and between the hole 11 and the fixation point 13, respectively. The expanded diameter is made equal to or even larger than the original diameter as shown in fig. 18B, so that a more optimal adherence effect can be obtained and a target lumen with a larger range of diameter variation can be accommodated.

Seventh embodiment

In the seventh embodiment, the adherence adjusting wire 8 disposed inside the rf ablation catheter is composed of multiple wires, wherein the front end of each wire is fixed on the electrode holder, the rear end of each wire externally bypasses a section of spiral section of the electrode holder and enters the electrode holder or the catheter body, and then passes through the lumen of the catheter body and out of the end of the catheter body, and is fixed on the corresponding control member disposed on the control handle 20, or is fixed on the corresponding control member disposed outside after passing through the control handle 20, and the multiple wires are respectively used for independently controlling the diameters of different spiral sections of the electrode holder.

In the configuration shown in fig. 21, the anchorage-regulating wire 8 is composed of two

wires

84 and 85, the front ends of which are fixed together at a certain point of the electrode holder to form a fixing point 83, and the rear ends of which pass around different helical sections of the electrode holder to enter the interior of the electrode holder or catheter shaft, respectively, and return to the rear ends via lumens inside the electrode holder and catheter shaft and are fixed to corresponding control members in the control handle 20. The configuration of the anchorage-regulating wire 8 having two strands is substantially the same as that of the sixth embodiment, and can be used to separately control the diameter expansion of the front and rear helical sections of the electrode stent. Alternatively, the structure in the sixth embodiment can be directly understood as the case where two strands of the adhesion regulating wires 8 in the seventh embodiment are used.

When the wall-adhering adjusting wire 8 has more than two wires, the front end of each wire is fixed on the electrode bracket, the part close to the front end (i.e. close to the fixing point) is exposed outside the electrode bracket, the rear end enters the inside of the electrode bracket from holes arranged at different positions of the electrode bracket, and returns to the control handle 20 through the same lumen or different lumens inside the electrode bracket and the catheter body, and is fixed on the corresponding control part. Wherein, the fixing points of the multiple strands of wires on the electrode bracket can be the same, different or not completely the same. When the attachment points of the multiple wires to the electrode support are not exactly the same, each two wires may have a common attachment point to the electrode support, and the two wires may be arranged in the configuration shown in fig. 21. When the fixing points of the multiple filaments on the electrode holder are the same, the front ends of the different filaments may be fixed on the front end a of the electrode holder as shown in fig. 22A, and then the rear end of each filament enters the electrode holder from different holes B, C, D and more holes on the electrode holder, and passes out from the end of the catheter body through the electrode holder and the catheter body, and the ends E of the multiple filaments are fixed on the corresponding control members, respectively; alternatively, as shown in fig. 22B, the front ends of the different wires are fixed to one side D ' of the rear portion of the electrode holder, and then the rear end of each wire is inserted into the electrode holder through the different holes a ', B ', C ' and more holes of the electrode holder, which are located at the front portion, and is passed out from the end of the catheter tube through the electrode holder and the catheter tube, and the ends E ' of the multiple wires are respectively fixed to corresponding control members provided on the control handle 20 or corresponding control members provided outside. Each wire enters the interior of the electrode holder from a different location on the electrode holder so that the diameter change of the helical section between the point of attachment of the leading end of the wire and the location where the wire enters the electrode holder can be controlled by pulling a single wire. Of course, the multiple wires may be fixed to the same control member of the control handle 20, thereby adjusting the diameter of the electrode holder as a whole.

When a plurality of control pieces are used for respectively controlling different spiral sections of the electrode support, after the radiofrequency ablation catheter enters a target position, the corresponding spiral sections of the electrode support can be expanded in a segmented mode according to needs, namely, only the spiral sections needing the radiofrequency are expanded, so that the flexibility of adjusting the diameters of the different spiral sections of the electrode support is improved, and the difficulty of adjusting the adherence of the radiofrequency ablation catheter is reduced.

To sum up, be provided with the adherence adjusting wire in spiral type radiofrequency ablation catheter, through pulling the adherence adjusting wire backward, can change the spiral diameter of electrode support to improve the adherence state of electrode, make this radiofrequency ablation catheter be applicable to the blood vessel of different diameters. In addition, the wall-adhering adjusting wire can also adopt a multi-strand wire structure, so that different spiral sections of the radiofrequency ablation catheter can be controlled respectively, and the difficulty of diameter adjustment is simplified.

In actual clinical treatment, the radiofrequency ablation catheter and the radiofrequency ablation equipment provided by the invention can be applied to nerve ablation of different parts and various blood vessels or tracheas with different diameters. For example, in renal intra-arterial nerve ablation for treatment of refractory hypertension patients, in celiac intra-arterial nerve ablation for treatment of diabetes patients, and, for example, in tracheal/bronchial vagal branch ablation for treatment of asthma patients, and in duodenal vagal branch ablation for treatment of duodenal ulcer patients; in addition, the device can also be used for nerve ablation in other blood vessels or tracheas such as the renal pelvis, the pulmonary artery and the like. It should be noted that the rf ablation catheter provided by the present invention is not limited to the above-mentioned applications in clinical treatment, and can also be used for nerve ablation at other sites.

The invention also provides the radio frequency ablation equipment comprising the radio frequency ablation catheter. The radiofrequency ablation equipment comprises a radiofrequency ablation catheter and a radiofrequency ablation host connected with the radiofrequency ablation catheter. The adherent adjusting wires inside the electrode support penetrate through the catheter body and then are correspondingly connected to the control handle, and the shape of the electrode support can be changed by pulling the adherent adjusting wires through the control handle, so that the electrode support is good in wall adhesion in target lumens with different diameters. And the radio frequency wire and the thermocouple wire in the electrode bracket are respectively connected to corresponding circuits in the radio frequency ablation host machine through the catheter tube body, so that the radio frequency control and the temperature monitoring of the radio frequency ablation host machine on the plurality of electrodes are realized. Since the arrangement of the control handle and the arrangement of the radiofrequency ablation host can be referred to the prior patent application which is published by the applicant, the detailed structure thereof will not be described in detail.

The invention provides a spiral radiofrequency ablation catheter with an adherence adjusting wire and a device thereof. It will be apparent to those skilled in the art that various modifications can be made without departing from the spirit of the invention.

Claims

1. A spiral radio frequency ablation catheter with an adherence adjusting wire is provided with a long strip-shaped catheter tube body, wherein a spiral electrode support is arranged at the front end of the catheter tube body, and a plurality of electrodes are arranged on the electrode support; the electrode support is provided with a plurality of spiral sections, and a plurality of electrodes are arranged on different spiral sections; a control handle is arranged at the rear end of the catheter body; the method is characterized in that:

the wall-adhering adjusting wire consists of a plurality of wires, wherein the front end of each wire is fixed on the electrode bracket, the part close to the fixed point is exposed outside the electrode bracket, the rear end of each wire enters the electrode bracket from different positions of the electrode bracket after bypassing a section of spiral section of the electrode bracket, then penetrates out of the tail end of the catheter tube body through the lumen of the catheter tube body and is fixed on a corresponding control piece arranged on the control handle, or is connected to a corresponding control piece arranged outside after penetrating through the control handle; the multiple strands of wires are respectively used for independently controlling the diameter of the spiral section between the fixing point of each strand of wire and the position of each strand of wire entering the electrode support, so that the electrodes on the corresponding spiral sections adhere to the wall.

2. The helical radio frequency ablation catheter of claim 1, wherein:

the fixing points of the multiple strands of wires on the electrode support are different.

3. The helical radio frequency ablation catheter of claim 1, wherein:

in the multi-strand wires, every two strands of wires have a common fixing point on the electrode support.

4. The helical radio frequency ablation catheter of claim 1, wherein:

the fixing points of the multiple strands of wires on the electrode support are the same.

5. The helical radio frequency ablation catheter of claim 1, wherein:

the electrode bracket comprises an outer tube, the electrodes are embedded on the outer circumference of the outer tube, one or more tube cavities are arranged inside the outer tube, and a group of thermocouple wires and radio frequency wires are respectively arranged in partial tube cavities of the outer tube; the radio frequency wire and the thermocouple wire are arranged in each electrode, the radio frequency wire is connected with the electrodes, and the thermocouple wires and the electrodes are arranged in an insulating mode.

6. An RF ablation device, characterized in that it comprises the RF ablation catheter of any one of claims 1-5, and an RF ablation host connected with the RF ablation catheter.