CN219461380U

CN219461380U - Ablation catheter

Info

Publication number: CN219461380U
Application number: CN202320443745.XU
Authority: CN
Inventors: 郑黎晖; 赖子浩; 刘尚雨; 姚焰
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2023-03-09
Filing date: 2023-03-09
Publication date: 2023-08-04
Anticipated expiration: 2033-03-09

Abstract

The present utility model provides an ablation catheter comprising: the pipe comprises a pipe body, a handle, a camber adjusting section, a pipe head, an energy transmission channel and an ultrasonic detection device. Wherein, ultrasonic detection device sets up the juncture at the terminal surface of tube head and the side of tube head. The ablation catheter can detect the thickness of the atrial wall and the ablation depth of the area in front of the side face of the catheter and above the side face of the catheter, and has the advantages of large detection range, convenience in operation and compact structure.

Description

Ablation catheter

Technical Field

The utility model relates to the field of medical instruments, in particular to an ablation catheter. More particularly, the present utility model relates to an ablation catheter that can detect atrial wall thickness and ablation depth in real time.

Background

As one of the most common arrhythmia diseases, the incidence of atrial fibrillation increases with age, and the diseased population in China is huge. Catheter radio frequency ablation therapy has been a significant increase in demand in recent years as an effective radical treatment. The main working principle of the catheter radio frequency ablation is that under the monitoring of a radiography device, a radio frequency ablation catheter is introduced into a focus part in a patient body through puncturing a blood vessel, the position of an abnormal structure causing tachycardia is checked and determined, then energy is locally released at the position, a very high temperature is generated in a very small range, and moisture in local tissues is evaporated, dried and necrotized through thermal efficiency, so that the treatment purpose is achieved.

Ablation catheters currently on the market are generally equipped with general functions of temperature control, pressure control, power control, etc., however, because of individual variability, the atrial structures of each patient are not identical, and therefore it is necessary for the ablation catheter to provide targeted radiofrequency ablation therapy based on the atrial structure of each patient. In order for the ablation catheter to provide appropriate radio frequency ablation therapy for different atrial structures, accurate acquisition of atrial wall thickness data information is particularly important.

In addition, the existing radio frequency ablation catheter is difficult to accurately detect the endocardial injury condition (namely the ablation depth) in the ablation process at the ablation site in real time, which may cause excessive ablation or insufficient ablation, and the safety and success rate of the ablation are difficult to ensure.

There is therefore a need to develop a new atrial fibrillation ablation catheter to address the above-described problems.

Disclosure of Invention

The existing radio frequency ablation catheter has the functions of temperature control, pressure control, power control and the like, but the real-time condition of atrial muscle at an ablation site cannot be known, and the change of central intima tissue in the ablation process cannot be known, so that the risks of postoperative complications and postoperative arrhythmia recurrence are increased.

As a superior detection tool, ultrasound presents different imaging features in tissues of different nature, with great potential for detecting tissue structures. A common intra-cardiac detection means in the prior art is intra-cardiac ultrasound (ICE), however, intra-cardiac ultrasound (ICE) is generally only used to ascertain the overall structural condition of the heart chamber, and when it is used to monitor myocardial structural changes, the effect is often poor, and real-time detection of atrial wall thickness and ablation depth cannot be achieved. In addition, the mechanical probe design used for intracardiac ultrasound (ICE) is not suitable for atrial fibrillation surgery, is oversized and faces dilemma when combined with ablation catheters.

To this end, the present utility model provides an ablation catheter comprising:

a tube body in the form of a hollow tube having a proximal end and a distal end;

the handle is provided with a proximal end and a distal end, and the distal end of the handle is connected with the proximal end of the pipe body;

a camber adjusting section having a proximal end and a distal end, the proximal end of the camber adjusting section being connected to the distal end of the tube body, the camber adjusting section being capable of adjusting camber along its axial direction;

the tube head is in the form of a hollow tube and is provided with a proximal end and a distal end, the distal end of the tube head is closed, and the proximal end of the tube head is connected with the distal end of the camber adjusting section;

an energy transmission path provided inside the pipe head, the pipe body, the handle, and the camber adjustment section, and connected at one end with the pipe head so as to be able to transmit energy to the pipe head, the energy transmission path being connected at the other end with an energy input interface provided on the handle; and

the ultrasonic detection device comprises an ultrasonic detection unit and an ultrasonic detection unit lead, wherein the ultrasonic detection unit can emit and detect high-frequency sound beams, and the ultrasonic detection unit lead is connected with the ultrasonic detection unit at one end and connected with an ultrasonic connecting seat arranged on the handle at the other end; wherein, ultrasonic detection device sets up the terminal surface of tube head with the juncture of the side of tube head. Preferably, a part of the ultrasound detection device, in particular the ultrasound detection unit, protrudes from the outer surface of the cartridge. Alternatively, a part of the ultrasound detection device, in particular the ultrasound detection unit, is flush with the outer surface of the cartridge.

The ablation catheter disclosed by the utility model is compactly combined with the ultrasonic detection device on the basis of the existing ablation catheter, and can realize real-time detection of the thickness of the atrial wall and the ablation depth. The ultrasound probe used in the present utility model is preferably in the form of an array of ultrasound crystals connected in a phased array, wherein the size of the individual ultrasound crystals is small (typically below 0.3 mm), making the overall device compact in size. In use, the ultrasonic crystal array directly emits high-frequency sound beams (generally more than 10 MHz) to the surface to be measured, and has the advantages of high separation rate and strong penetrating power. When the ultrasound crystal array is combined with the ablation catheter, better detection of atrial wall thickness and ablation depth can be achieved.

In particular to the utility model, the ultrasonic detection device is arranged at the junction of the end face of the tube head and the side face of the tube head, so that the detection range of the ultrasonic detection device covers the front part of the end face of the ablation catheter and the upper part of the side face of the ablation catheter. The ultrasonic detection device provides a wide detection range for the ablation catheter, so that in use, an operator can realize real-time detection of the thickness of the atrial wall and the ablation depth without additional fine adjustment, and the ultrasonic detection device has the advantages of convenience in operation and compact structure. Furthermore, an ultrasound detection device arranged in this manner means that the distance from the ablation site is always small, thereby improving the quality and resolution of ultrasound detection.

Drawings

The advantages and features of the present utility model will now be described in detail with reference to the accompanying drawings, in which the various components are not necessarily drawn to scale, and wherein:

fig. 1 shows a front view of one embodiment of an ablation catheter of the present utility model.

Fig. 2 is an enlarged view of a portion of fig. 1, wherein the ablation catheter is sectioned along a vertical plane to show internal details.

Fig. 3 shows a perspective view of the end of another embodiment of the ablation catheter of the utility model.

Fig. 4 shows a perspective view of the end of yet another embodiment of the ablation catheter of the utility model.

Fig. 5 shows a front view of one embodiment of the ultrasound probe of the ablation catheter of the utility model, showing in particular details of the ultrasound probe.

It is to be understood that the drawings are designed solely for the purposes of illustration and not as a definition of the limits of the utility model.

Detailed Description

In the present specification, the "proximal end and distal end" are defined with reference to the position of the operator, that is, the end closer to the operator in use is referred to as "proximal end" and the end farther from the operator is referred to as "distal end".

The present utility model provides an ablation catheter comprising:

It should be understood that the "high-frequency sound beam" as used herein refers to an ultrasonic sound beam having a frequency range of 10MHz or more.

In a preferred embodiment of the present utility model, the ultrasonic detection unit is connected to both the end face of the tip and the side face of the tip. In this way, when the ultrasonic detection units are in the form of a plurality of independent units, the central axis direction of each ultrasonic detection unit can form an obtuse angle with the plane direction of the end face of the ferrule. Alternatively, when the ultrasonic detection unit is in a sheet form, it can cover a portion of the end face of the tip and a portion of the side face of the tip at the same time. These specific configurations described above all achieve the technical effects described above of covering the front of the end of the ablation catheter and over the side of the ablation catheter.

In a preferred embodiment of the present utility model, an ultrasonic device mounting surface is provided at the junction of the end face of the tip and the side face of the tip, the plane direction of the ultrasonic device mounting surface and the plane direction of the end face of the tip form an obtuse angle, and the ultrasonic detection unit is provided on the ultrasonic device mounting surface. Preferably, the obtuse angle formed by the planar direction of the ultrasonic device mounting surface and the planar direction of the end face of the ferrule is in the range of 95 degrees to 175 degrees, more preferably in the range of 130 degrees to 140 degrees, still more preferably 135 degrees. In the case that the obtuse angle formed by the plane direction of the ultrasonic device mounting surface and the plane direction of the end surface of the ferrule is small, the area above the side surface of the ablation catheter detectable by the ultrasonic detection unit is large. Conversely, the ultrasonic detection unit can realize better detection on the front of the ablation catheter under the condition that the obtuse angle formed by the plane direction of the ultrasonic device mounting surface and the plane direction of the end surface of the tube head is larger. More preferably, the ultrasound detection unit is in the form of a plurality of individual units. The ranges of the plurality of independent ultrasonic detection units overlap each other to form a wider detection range, particularly a detection range covering the front of the end face of the ablation catheter and the upper side face of the ablation catheter. Still more preferably, the ultrasonic device mounting surface is a continuous surface extending in a circumferential direction of the tip, and the ultrasonic detection units are uniformly distributed in the circumferential direction of the tip. The ultrasonic device mounting surface which extends continuously along the circumference of the tube head has the advantages of simple processing and smooth surface. Alternatively, the ultrasonic device mounting surface is a plurality of independent mounting planes uniformly distributed along the circumferential direction of the pipe head, wherein at least one ultrasonic detection unit is provided on each independent mounting plane. For example, the ultrasonic device mounting surface includes three mounting planes, each of which is provided with one ultrasonic detection unit, i.e., the angular interval between adjacent ultrasonic detection units is 120 degrees. The provision of a separate mounting plane makes the mounting plane itself flat, which facilitates the mounting of the ultrasound probe unit.

It should be understood that in practical applications, the skilled person may arrange more or fewer ultrasound detection units, e.g. two, three, four ultrasound detection units, according to technical requirements. More ultrasound detection units make high frequency beam coverage more coherent, while fewer ultrasound detection units reduce the complexity and cost of the ablation catheter.

In a preferred embodiment of the utility model, the ultrasound detection unit comprises a sensing surface for emitting and detecting high frequency sound beams, the sensing surface having an array of ultrasound crystals arranged thereon. Preferably, the ultrasound crystals in the array of ultrasound crystals are connected in a phased array and each of the ultrasound crystals has a size below 0.5mm, more preferably below 0.3mm, still more preferably below 0.2 mm. More preferably, the frequency of the high frequency sound beam emitted by the ultrasound crystal is above 10MHz, preferably in the range of 20MHz to 40 MHz. More preferably, the penetration depth of the ultrasound crystal is up to 5mm or more. In use, the ablation catheter of the utility model is capable of covering substantially the entire longitudinal length of the endocardial myocardium and has a longitudinal tissue resolution of up to 0.1mm to 0.15mm, preferably up to 0.08mm to 0.1mm. Under the background of the high-frequency ultrasonic crystal array, the spatial resolution and contrast resolution of the image are greatly improved, different tissue types in cardiac muscle and adjacent micro targets among tissues can be resolved, and the image is soft and fine.

In a preferred embodiment of the utility model, the ultrasound detection unit is in the form of a partial sphere, the sphere of which acts as the sensing surface, enabling the emission and detection of high frequency sound beams in the direction of the normal to the sphere. For example, the ultrasound detection unit is in the form of a hemisphere. The hemispherical ultrasound probe unit causes the high frequency sound beam to propagate outwardly in a generally hemispherical form. In this way, a single said ultrasound probe unit can cover a larger area. It should be understood that, due to the characteristic of diffusion propagation of the high-frequency sound beam, the actual propagation form of the high-frequency sound beam emitted by the hemispherical ultrasonic detection unit is often larger than that of a hemisphere. More preferably, the ultrasonic detection unit further includes a plurality of longitude mounting grooves extending in a longitudinal direction of the spherical surface, wherein a plurality of ultrasonic crystals are provided in each of the longitude mounting grooves. Still more preferably, the ultrasonic detection unit further includes a plurality of latitude mounting grooves extending in a latitudinal direction of the spherical surface, wherein a plurality of ultrasonic crystals are provided in each of the latitude mounting grooves. The ultrasound crystals in the longitude and/or latitude mounting slots preferably cooperate in a phased array mode, with each ultrasound crystal covering a sector. The configuration structure of the combination of the longitude/latitude mounting groove and the ultrasonic crystal is simple, and the coverage effect is good.

In a preferred embodiment of the present utility model, the ablation catheter further comprises an irrigation pathway disposed within the tip, shaft, handle, and bend adjustment section, the irrigation pathway having one end being an irrigation port disposed on the handle and the other end being a plurality of irrigation ports disposed on the tip. It will be appreciated that the perfusion pathway is capable of allowing passage of a therapeutic or functional agent, such as saline.

In a preferred embodiment of the present utility model, the ablation catheter further comprises: a mapping electrode and a mapping electrode lead connected with the mapping electrode; the mapping electrode is arranged on the outer surface of the tube head and/or the tube body and used for mapping electrocardiosignals, and the mapping electrode lead is arranged inside the tube head, the tube body, the handle and the camber adjusting section and is connected with the signal connecting seat arranged on the handle.

In a preferred embodiment of the present utility model, the ablation catheter further comprises a position detection device comprising: a magnetic navigation coil and a magnetic navigation wire; the magnetic navigation coil is arranged in the tube head, the magnetic navigation lead is arranged in the tube head, the tube body, the handle and the bending adjustment section, one end of the magnetic navigation lead is connected with the magnetic navigation coil, and the other end of the magnetic navigation lead is connected with the signal connection seat. The magnetic navigation coil can use its electromagnetic properties to spatially identify the position of the ablation catheter, and in particular the end of the ablation catheter, thereby achieving a position detection function.

In a preferred embodiment of the present utility model, the ablation catheter further comprises: a camber adjusting device; wherein, the camber adjusting device can adjust the camber of camber adjusting section. Preferably, the camber adjustment device comprises an adjustment knob provided on the handle.

In a preferred embodiment of the present utility model, the ablation catheter further comprises: a pressure sensor for detecting the attachment pressure at the ablation site (i.e., the pressure of the catheter against the myocardial tissue), and a pressure sensor lead. Wherein the pressure sensor is arranged in the tube head, in particular in a polymer material layer of the tube head. The pressure sensor wire is arranged inside the pipe head, the pipe body, the handle and the camber adjusting section, and is connected with the pressure sensor at one end and the signal connecting seat at the other end. The pressure sensor is connected with a pressure sensor wire, a pressure detection signal is transmitted to an external system through the pipe body, and the contact and stress condition of the ablation part is calculated.

In a preferred embodiment of the present utility model, the ablation catheter further comprises: the device comprises a temperature sensor for detecting the ablation temperature, a power sensor for detecting the ablation power and sensor wires corresponding to the various sensors. The various sensors are arranged in the pipe head, in particular in a polymer material layer of the pipe head. All kinds of sensor wires are arranged inside the pipe head, the pipe body, the handle and the camber adjusting section, one end of each sensor wire is connected with a corresponding sensor, and the other end of each sensor wire is connected with the signal connecting seat. Preferably, the ablation catheter further comprises: a wire passageway disposed inside the tube head, tube body, handle and bend adjustment section for allowing various wires (such as ultrasound probe unit wires, mapping electrode wires, magnetic navigation wires, sensor wires, etc.) to pass through.

The ablation catheter can display different tissue types in different colors by using an ultrasonic virtual histological computer technology at the output end of a detection result, and can be used for identifying, measuring and analyzing, so that an operator can effectively, accurately and quantitatively evaluate and judge the myocardial tissue change condition and the ablation depth in the ablation process, timely adjust parameters such as the ablation pressure, duration, temperature, power and the like if necessary, ensure the effectiveness and safety of an operation to a greater extent, and provide reliable and objective basis for the operator to formulate and implement a quantitative and individual ablation treatment strategy.

The components of the ablation catheter can be made of materials such as plastics, metals and the like, and are prepared by a common processing and forming method. Specifically, the plastic material may be ABS (acrylonitrile butadiene styrene), nylon, polyurethane, etc., and the metal material may be stainless steel, aluminum, copper, etc. If plastic materials are used, the usual process molding methods are injection molding, extrusion molding, etc. If a metal material is used, the usual forming methods are machining, casting, stamping, bending and the like. Preferably, the camber adjusting section is made of flexible materials or metal materials (such as metal braiding materials) easy to deform, the mapping electrode is a platinum iridium ring electrode, the tube head and the tube body are provided with metal shells, a high polymer material layer and a metal net layer are sequentially arranged inside the tube head and the tube body, and an insulating layer is arranged outside the wire.

The various sections of the ablation catheter of the utility model, particularly the tip, shaft, handle and bend adjustment section, are joined by conventional medical material joining methods, such as heat sealing.

Specific embodiments of the present utility model will be described below with reference to the accompanying drawings, but the present utility model is not limited to these specific embodiments.

Fig. 1 shows a front view of one embodiment of an ablation catheter of the present utility model. As shown in fig. 1, an ablation catheter 1 includes: the pipe comprises a pipe body 2, a handle 3 connected with the proximal end of the pipe body 2, a bending degree adjusting section 4 connected with the distal end of the pipe body 2, and a pipe head 5 connected with the distal end of the bending degree adjusting section 4. Four platinum iridium ring electrodes 6 are further arranged on the outer surfaces of the tube head 5 and the tube body 2, and the platinum iridium ring electrodes 6 form two groups of mapping electrodes for collecting electrocardiosignals. At the distal end of the handle 3 is also connected: a signal connection socket 7 for connecting various types of wires, an irrigation interface 8 for introducing a liquid to be irrigated, an energy input interface 9 for introducing ablation energy, and an ultrasound connection socket 10 for inputting and outputting ultrasound signals. The handle 3 is also provided with two adjusting knobs 3A, 3B for adjusting the camber. In addition, 6 pouring spouts 5A for dispensing pouring liquid are provided on the tube head 5, wherein 3 pouring spouts 5A are provided on the opposite side, which is not shown in fig. 1. In addition, an ultrasonic device mounting surface 5B is provided at the junction of the end surface of the ferrule 5 and the side surface of the ferrule 5, the plane direction of the ultrasonic device mounting surface 5B forms an angle of 135 degrees with the plane direction of the end surface of the ferrule 5, and two ultrasonic detection units 11 provided opposite to each other in the circumferential direction of the ferrule 5 are provided on the ultrasonic device mounting surface 5B.

Fig. 2 is an enlarged view of a portion of fig. 1, wherein the ablation catheter is sectioned along a vertical plane to show internal details. As shown in fig. 2, the tube body 2 and the tube head 5 are in the form of a hollow tube, containing: an ultrasound probe unit wire 12, an energy transmission path 13, a perfusion path 14, and a magnetic navigation wire 15. The pipe head 5 and the pipe body 2 have metal shells, and their inner walls are provided with a polymer material layer and a metal mesh layer in order. At the junction of the magnetic navigation wire 15 and the pipe head 5, a magnetic navigation coil 16 is provided in the polymer material layer of the pipe head 5.

Fig. 3 shows a perspective view of the end of another embodiment of the ablation catheter of the utility model. This figure 3 shows in particular an alternative ultrasound detection unit arrangement. As shown in fig. 3, the ultrasonic device mounting surface 5B 'is a continuous surface extending along the entire circumferential direction of the tip 5'. The three ultrasonic detection units 11 are uniformly distributed along the circumferential direction of the pipe head 5' such that the angular interval between adjacent ultrasonic detection units 11 is 120 degrees.

Fig. 4 shows a perspective view of the end of yet another embodiment of the ablation catheter of the utility model. This fig. 4 shows in particular another alternative ultrasound detection unit arrangement. As shown in fig. 4, the ultrasonic device mounting surface 5B "is three independent mounting planes uniformly distributed along the circumferential direction of the tip 5", wherein one ultrasonic detection unit 11 is provided on each mounting plane. The angular spacing between adjacent ultrasound probe units 11 is likewise 120 degrees.

Fig. 5 shows a front view of one embodiment of the ultrasound probe of the ablation catheter of the utility model, showing in particular details of the ultrasound probe. As shown in fig. 5, the ultrasonic probe 11 is in the form of a hemisphere, to which an ultrasonic probe wire 12 is connected. A plurality of longitude-mounting grooves 11A extending in the longitude direction and a plurality of latitude-mounting grooves 11B extending in the latitude direction are arranged on the spherical surface of the ultrasonic detection unit 11, and a plurality of ultrasonic crystals are provided on each of the longitude-mounting grooves 11A and the latitude-mounting grooves 11B, thereby constituting an array.

While various preferred embodiments have been shown and described above, it will be apparent to those skilled in the art that modifications and variations can be made without departing from the scope of the utility model as defined in the appended claims.

Claims

1. An ablation catheter, comprising:

the ultrasonic detection device comprises an ultrasonic detection unit and an ultrasonic detection unit lead, wherein the ultrasonic detection unit can emit and detect high-frequency sound beams, and the ultrasonic detection unit lead is connected with the ultrasonic detection unit at one end and connected with an ultrasonic connecting seat arranged on the handle at the other end; wherein, ultrasonic detection device sets up the terminal surface of tube head with the juncture of the side of tube head.

2. The ablation catheter of claim 1, wherein the ultrasound probe unit is connected to both the end face of the tip and the side face of the tip.

3. The ablation catheter of claim 1, wherein an ultrasonic device mounting surface is provided at a junction of an end surface of the tip and a side surface of the tip, a plane direction of the ultrasonic device mounting surface and a plane direction of the end surface of the tip form an obtuse angle, and the ultrasonic detection unit is provided on the ultrasonic device mounting surface.

4. The ablation catheter of claim 3, wherein the ultrasound detection unit is in the form of a plurality of individual units.

5. The ablation catheter of claim 4, wherein the ultrasound device mounting surface is a continuous surface extending along a circumference of the tip, the ultrasound probe units being evenly distributed along the circumference of the tip.

6. The ablation catheter of claim 4, wherein the ultrasound device mounting surface is a plurality of individual mounting planes uniformly distributed along a circumferential direction of the tip, wherein each individual mounting plane has at least one of the ultrasound probe units disposed thereon.

7. The ablation catheter of claim 6, wherein the ultrasound device mounting surface comprises three of the mounting planes.

8. The ablation catheter of any one of claims 1-7, wherein the ultrasound detection unit comprises a sensing surface for emitting and detecting high frequency acoustic beams, the sensing surface having an array of ultrasound crystals disposed thereon.

9. The ablation catheter of claim 8, wherein the ultrasound crystals in the array of ultrasound crystals are connected in a phased array and each of the ultrasound crystals has a size of 0.5mm or less.

10. The ablation catheter of claim 8, wherein the ultrasound detection unit is in the form of a partial sphere, the sphere of which acts as the sensing surface, enabling the emission and detection of high frequency sound beams in the direction normal to the sphere.

11. The ablation catheter of claim 10, wherein the ultrasound probe unit further comprises a plurality of longitudinal mounting slots extending along a longitudinal direction of the sphere, wherein each of the longitudinal mounting slots has a plurality of ultrasound crystals disposed therein.

12. The ablation catheter of claim 10, wherein the ultrasound probe unit further comprises a plurality of latitudinal mounting slots extending latitudinally along the sphere, wherein each of the latitudinal mounting slots has a plurality of ultrasound crystals disposed therein.

13. The ablation catheter of any of claims 1-7, further comprising an irrigation pathway disposed inside the tip, shaft, handle, and bend adjustment section, the irrigation pathway having one end being an irrigation port disposed on the handle and the other end being a plurality of irrigation ports disposed on the tip.

14. The ablation catheter of any of claims 1-7, further comprising: a mapping electrode and a mapping electrode lead connected with the mapping electrode; the mapping electrode is arranged on the outer surface of the tube head and/or the tube body and used for mapping electrocardiosignals, and the mapping electrode lead is arranged inside the tube head, the tube body, the handle and the camber adjusting section and is connected with the signal connecting seat arranged on the handle.