CN219250395U - Ultrasonic ablation catheter device - Google Patents

Abstract

The embodiment of the application provides an ultrasonic ablation catheter device, which comprises a catheter and an ultrasonic transducer assembly arranged at the distal end of the catheter; the ultrasonic transducer assembly comprises an ultrasonic ablation piezoelectric wafer, an ultrasonic imaging piezoelectric wafer and a backing; the backing is shared by the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer and is used for attenuating and absorbing sound waves radiated by the back surface of the ultrasonic ablation piezoelectric wafer and sound waves radiated by the back surface of the ultrasonic imaging piezoelectric wafer; the ultrasonic transducer assembly may be actuated to rotate to change the direction of radiation of the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer. The backing provided by the embodiment of the application is shared by the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer and is used for attenuating and absorbing the sound waves radiated by the back surface of the ultrasonic ablation piezoelectric wafer and the sound waves radiated by the back surface of the ultrasonic imaging piezoelectric wafer, so that the number of the backing is reduced, the miniaturization of the ultrasonic transducer assembly is realized, and the structure is more simplified.

Description

Ultrasonic ablation catheter device

Technical Field

The application relates to the technical field of medical instruments, in particular to an ultrasonic ablation catheter device.

Background

The ultrasonic ablation catheter is used for guiding a catheter to enter a human body in a minimally invasive mode and ablating solid tissues such as tumors or nerve tissues through ultrasonic. For example, upon ablation of the sympathetic renal artery, an ultrasound ablation catheter enters the renal artery in a minimally invasive manner; ultrasonic waves emitted by an ultrasonic ablation transducer on the ultrasonic ablation catheter can be transmitted in blood and directly act outside blood vessels to realize the ablation of sympathetic nerves.

In some embodiments, the ultrasound ablation catheter also has an ultrasound imaging transducer for observing the condition of the tissue to be ablated during the interventional procedure. However, in this embodiment, the distal end of the catheter needs to be provided with an independent ultrasonic ablation transducer and an ultrasonic imaging transducer at the same time, which may cause local volume at the distal end of the catheter and the ultrasonic imaging transducer to be too large.

Disclosure of Invention

Embodiments of the present application provide an ultrasound ablation catheter device, which has a small volume and a compact structure of an ultrasound transducer assembly.

In one embodiment of the present application, an ultrasound ablation catheter apparatus is provided that includes a catheter and an ultrasound transducer assembly disposed at a distal end of the catheter;

the ultrasonic transducer assembly comprises

Ultrasonically ablating the piezoelectric wafer; the front surface of the ultrasonic ablation piezoelectric wafer faces to human tissues and is used for generating sound waves to ablate target human tissues;

an ultrasound imaging piezoelectric wafer; the front surface of the ultrasonic imaging piezoelectric wafer faces to human tissues and is used for generating sound waves to image target human tissues;

a backing; the back lining is shared by the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer and is used for attenuating and absorbing sound waves radiated by the back surface of the ultrasonic ablation piezoelectric wafer and sound waves radiated by the back surface of the ultrasonic imaging piezoelectric wafer;

the ultrasonic transducer assembly is actuatable for rotation to change the direction of acoustic wave radiation of the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer.

The backing is shared by the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer, is used for attenuating and absorbing sound waves radiated by the back surface of the ultrasonic ablation piezoelectric wafer and sound waves radiated by the back surface of the ultrasonic imaging piezoelectric wafer, reduces the number of the backing, achieves miniaturization of the ultrasonic transducer assembly, and is simpler in structure.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without the need for inventive labour for a person skilled in the art.

FIG. 1 is a schematic structural view of an ultrasound ablation catheter device provided in one embodiment of the present application;

FIG. 2 is a schematic structural view of an ultrasonic transducer assembly according to another embodiment of the present application;

FIG. 3 is a schematic structural view of an ultrasonic transducer assembly according to another embodiment of the present application;

FIG. 4 is a schematic representation of a three-dimensional ultrasound image of a target vessel generated by an embodiment of the present application;

fig. 5 is a flow chart of ultrasound ablation by an embodiment of the present application.

Reference numerals illustrate:

101. a conduit; 102. ultrasonically ablating the piezoelectric wafer; 103. an ultrasound imaging piezoelectric wafer; 104. a backing; 105. a transmission shaft; 106. a housing; 107. a liquid inlet channel; 108. a liquid outlet channel; 109. a driving mechanism; 110. an ablation console; 111. an imaging console; 201. a target ablation zone.

Detailed Description

The technical solution of the present utility model will be described in detail below with reference to the accompanying drawings and the specific embodiments, it being understood that these embodiments are for illustrating the utility model only and not for limiting the scope, and that various equivalent modifications of the utility model will fall within the scope defined by the present application by those skilled in the art after reading the present utility model.

It will be understood that when an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The term "proximal" as used herein refers to the side closer to the operator and the term "distal" refers to the side farther from the operator.

The shock wave balloon catheter apparatus of the embodiments of the present specification will be explained and explained with reference to fig. 1 to 5. In the embodiments of the present utility model, like reference numerals denote like components. While, for the sake of brevity, detailed descriptions of the same components are omitted in the different embodiments, and the descriptions of the same components may be referred to and cited with each other.

An embodiment of the present application provides an ultrasound ablation catheter device, as shown in fig. 1, including a catheter 101 and an ultrasound transducer assembly disposed at a distal end of the catheter 101;

the ultrasonic transducer assembly comprises

Ultrasonically ablating the piezoelectric wafer 102; the front surface of the ultrasonic ablation piezoelectric wafer 102 faces to human tissues and is used for generating sound waves to ablate target human tissues;

an ultrasound imaging piezoelectric wafer 103; the front surface of the ultrasonic imaging piezoelectric wafer 103 faces to human tissues and is used for generating sound waves to image target human tissues;

a backing 104; the backing 104 is shared by the ultrasonic ablation piezoelectric wafer 102 and the ultrasonic imaging piezoelectric wafer 103, and is used for attenuating and absorbing sound waves radiated from the back surface of the ultrasonic ablation piezoelectric wafer 102 and sound waves radiated from the back surface of the ultrasonic imaging piezoelectric wafer 103;

the ultrasound transducer assembly may be actuated to rotate to change the direction of acoustic wave radiation of the ultrasound ablation piezoelectric wafer 102 and the ultrasound imaging piezoelectric wafer 103.

The sound wave generated by the piezoelectric wafer under the excitation of the electric pulse signal can propagate to the front and back directions at the same time.

Ideally, the acoustic energy generated by the piezoelectric wafer is propagated as much as possible into the body tissue in the frontal direction. Thus, for acoustic wave energy to propagate toward the back side of a piezoelectric wafer, it should be reflected back from the corresponding back side of the piezoelectric wafer and re-propagate toward the front side.

When the sound wave propagates through different media, reflection and transmission exist, one part of energy is reflected back at the interface, the other part of energy continues to propagate forwards, and the proportion of the reflected energy is proportional to the difference of acoustic impedances of the media at two sides of the interface.

In order to allow more reflection of the acoustic wave energy at the back of the piezoelectric wafer, a backing is required. The acoustic impedance of the backing should be as much smaller or much larger than the acoustic impedance of the wafer. For example, acoustic impedance 33MRayl of PZT; then either a low resistance soft backing (1-5 MRayl) or a high resistance hard backing (> 50 MRayl) can be selected. In addition, the sound waves transmitted into the backing should not reflect off the interior of the backing and return back to the piezoelectric wafer because the sound waves reflected off the interior of the backing will project information on the image of the interior of the backing, creating artifacts. We will generally choose a backing material with a high attenuation coefficient to absorb sound waves that enter the backing.

In some embodiments, the distal end of the catheter is required to be provided with an independent ultrasonic ablation transducer and an ultrasonic imaging transducer simultaneously, i.e. the ultrasonic ablation transducer comprises a piezoelectric wafer and a backing, and the ultrasonic imaging transducer comprises a piezoelectric wafer and a backing; resulting in excessive local volume at the distal end of the catheter.

In this embodiment, the backing 104 is shared by the ultrasonic ablation piezoelectric wafer 102 and the ultrasonic imaging piezoelectric wafer 103, and is used for attenuating and absorbing the sound wave radiated from the back surface of the ultrasonic ablation piezoelectric wafer 102 and the sound wave radiated from the back surface of the ultrasonic imaging piezoelectric wafer 103. Compared to providing separate ultrasound ablation transducers and ultrasound imaging transducers at the distal end of the catheter 101 simultaneously, the number of backings 104 is reduced, resulting in a smaller volume and a more compact structure of the ultrasound transducer assembly.

In an alternative embodiment, the ultrasound ablation piezoelectric wafer 102 may be a non-focused, flat single element transducer, thermal ablation may be achieved within tissue, with the maximum heating area concentrated in the tissue about 2mm to 9mm from the front side of the ultrasound ablation piezoelectric wafer 102 along the ultrasound beam axis, and in addition, the combination of the delivered energy level, the time of application, and the direction of the ultrasound beam may determine the volume of ablated tissue. In some embodiments, the ultrasound frequency may be selected to be about 10MHz to about 30MHz for the ultrasound ablation piezoelectric wafer 102 having a width of about 2mm and a length of about 4 mm. Preferably, the ultrasonic radiation angle of the ultrasonic ablation piezoelectric wafer 102 is smaller than 360 degrees, so as to realize targeted ablation; the smaller the ultrasonic radiation angle of the ultrasonic ablation piezoelectric wafer 102, the higher the targeting accuracy of ablation.

In an alternative embodiment, having a plurality of said ultrasound imaging piezoelectric wafers 103 arranged linearly along the axial direction of the catheter 101, a set of ultrasound imaging piezoelectric wafers 103 is formed. During ultrasonic imaging, the ultrasonic transducer assembly is in a rotational state, so that a plurality of ultrasonic three-dimensional imaging can be locally performed, which are linearly arranged along the axial direction of the catheter 101, for observing and locating target human tissue. The three-dimensional ultrasound image is formed as shown in fig. 4, and a target ablation region 201 is determined according to the distribution of the target human tissue in the three-dimensional ultrasound image.

In an alternative embodiment of the backing 104, as shown in fig. 1, the backing 104 is in the form of a flat plate having opposing first and second plate faces; the back surface of the ultrasonic ablation piezoelectric wafer 102 is fixedly connected to the first plate surface; the back surface of the ultrasonic imaging piezoelectric wafer 103 is bonded and fixed on the second plate surface. The ultrasonic ablation piezoelectric wafer 102 shares the backing 104 with the ultrasonic imaging piezoelectric wafer 103, and the ultrasonic ablation piezoelectric wafer 102 and the ultrasonic imaging piezoelectric wafer 103 are arranged back to back on both sides of the backing 104 in a flat plate shape.

Optionally, the axial ablation zone of the ultrasound ablation piezoelectric wafer 102 is located within the axial imaging zone of the ultrasound imaging piezoelectric wafer 103. When the ultrasonic imaging piezoelectric wafer 103 finds the target human tissue, the ultrasonic ablation piezoelectric wafer 102 can be aligned to the target human tissue by rotating the ultrasonic transducer assembly by 180 degrees without axially moving the ultrasonic transducer assembly, so that targeted ablation is realized.

In another alternative embodiment of the backing 104, as shown in fig. 2, the backing 104 is prismatic, having at least three prismatic sides; preferably, the axis of the backing 104 is perpendicular to the cross-section of the catheter 101; the prism may be selected from triangular prism, quadrangular prism, pentagonal prism, and others, which are not limited in this application.

The back surface of the ultrasonic ablation piezoelectric wafer 102 is bonded and fixed on one of the prism side surfaces; the back side of the ultrasound imaging piezoelectric wafer 103 is bonded and fixed to at least one of the remaining prism sides.

In the embodiment shown in fig. 2, the backing 104 is triangular prism-shaped. Wherein the back side of the ultrasonic imaging piezoelectric wafer 103 is bonded and fixed on one of the prism sides; the other two prism sides are respectively jointed and fixed with the back surfaces of a group of ultrasonic ablation piezoelectric wafers 102. According to the position of the target human tissue to be ablated, one group of ultrasonic ablation piezoelectric wafers 102 can be selectively opened during the ablation operation; or simultaneously opening two groups of ultrasonic ablation piezoelectric wafers 102 to ablate target human tissues at a plurality of positions.

Optionally, the axial ablation zone of the ultrasound ablation piezoelectric wafer 102 is located within the axial imaging zone of the ultrasound imaging piezoelectric wafer 103. When the ultrasonic imaging piezoelectric wafer 103 finds the target human tissue, the ultrasonic ablation piezoelectric wafer 102 can be aligned to the target human tissue by rotating the ultrasonic transducer assembly by 120 degrees without axially moving the ultrasonic transducer assembly, so that targeted ablation is realized.

In another alternative embodiment of the backing 104, as shown in fig. 3, the backing 104 is cylindrical or annular; preferably, the axis of the backing 104 is perpendicular to the cross-section of the catheter 101;

the ultrasonic ablation piezoelectric wafer 102 and the ultrasonic imaging piezoelectric wafer 103 are each disposed on the outer peripheral surface of the backing 104. The ultrasound ablation piezoelectric wafer 102 and the ultrasound imaging piezoelectric wafer 103 may both have any angle in the circumferential direction.

For example, in an alternative embodiment, the ultrasound ablation piezoelectric wafer 102 is symmetrically disposed with respect to the ultrasound imaging piezoelectric wafer 103 at an angle of 180 °. Optionally, the axial ablation zone of the ultrasound ablation piezoelectric wafer 102 is located within the axial imaging zone of the ultrasound imaging piezoelectric wafer 103. When the ultrasonic imaging piezoelectric wafer 103 finds the target human tissue, the ultrasonic ablation piezoelectric wafer 102 can be aligned to the target human tissue by rotating the ultrasonic transducer assembly by 180 degrees without axially moving the ultrasonic transducer assembly, so that targeted ablation is realized.

As another example, in another alternative embodiment as shown in fig. 3, the number of ultrasound ablation piezoelectric wafers 102 is three, and the number of ultrasound imaging piezoelectric wafers 103 is one; three sets of the ultrasonic ablation piezoelectric wafers 102 and one set of the ultrasonic imaging piezoelectric wafers 103 are circumferentially spaced apart along the outer peripheral surface of the backing 104. According to the position of the target to be ablated, one group of the ultrasonic ablation piezoelectric wafers 102 can be selectively opened or a plurality of groups of the ultrasonic ablation piezoelectric wafers 102 can be simultaneously opened during the ablation operation, so that the target human tissues at a plurality of positions are ablated.

In an alternative embodiment, the ultrasound transducer assembly is fixed to the catheter 101 and is rotatable with the catheter 101. Preferably, the axis of rotation of the ultrasound transducer assembly is perpendicular to the cross section of the catheter 101.

In another alternative embodiment shown in fig. 1, the device further comprises a drive shaft 105; the drive shaft 105 is disposed within the catheter 101, and the drive shaft 105 extends in an axial direction of the catheter 101. Preferably, the axis of rotation of the ultrasound transducer assembly is perpendicular to the cross section of the catheter 101.

The ultrasonic transducer assembly is disposed at the distal end of the drive shaft 105; specifically, backing 104 may be fixedly attached to the distal end of drive shaft 105; or the distal end of the drive shaft 105 is provided with a base on which the ultrasonic transducer assembly is fixedly mounted.

A drive mechanism 109 is connected to the proximal end of the drive shaft 105; the driving mechanism 109 drives the ultrasonic transducer assembly to rotate through the transmission shaft 105.

In an alternative embodiment shown in fig. 1, the device further comprises a housing 106 wrapped around the periphery of the ultrasound transducer assembly. The housing 106 should, on the one hand, prevent the ultrasound transducer assembly from being in direct contact with the human body, and on the other hand, the housing 106 should also have good sound transmission properties, minimizing the ratio of emitted sound waves to absorbed sound waves. Optionally, the housing 106 is made of a thin polymer, such as nylon, and may also be visually transparent or translucent to allow for viewing of conditions within the housing 106.

In this embodiment, optionally, the catheter 101 is provided with a liquid inlet channel 107 and a liquid outlet channel 108; the liquid inlet channel 107 is communicated with the inner cavity of the shell 106 and is used for inputting cooling liquid into the inner cavity of the shell 106; the liquid outlet channel 108 is communicated with the inner cavity of the shell 106 and is used for discharging the cooling liquid in the inner cavity of the shell 106.

In an alternative embodiment shown in fig. 1, the device further comprises an ablation console 110. The ablation console 110 may be a computerized electrical signal generator that delivers high frequency alternating current to the ultrasound ablation piezoelectric wafer 102. The parameters delivered by the ablation console 110 may be selected by the user or may be automatically determined. For example, the ablation console 110 may read data from memory in the catheter 101 and deliver energy accordingly or in combination with desired parameters such as lesion depth.

The ablation control console 110 may also automatically adjust the delivery flow of the cooling liquid according to the energy output by the ultrasonic ablation piezoelectric wafer 102, so as to stably control the temperature of the ultrasonic ablation piezoelectric wafer 102.

In an alternative embodiment shown in fig. 1, the apparatus further comprises an imaging console 111. The imaging console 111 is configured to transmit control signals of the ultrasonic imaging piezoelectric wafer 103 to the ultrasonic imaging piezoelectric wafer 103; the imaging console 111 is also configured to receive signals from the ultrasound imaging piezoelectric wafer 103 and create a video of ultrasound based on the signals received from the ultrasound imaging piezoelectric wafer 103.

The ablation procedure was performed using the device of the above embodiment, including the following steps as shown in fig. 5:

s302, pushing the ultrasonic ablation catheter device to a target blood vessel through vascular interventional operation.

S304, performing ultrasonic three-dimensional imaging on a target blood vessel; the method specifically comprises the following steps: the imaging console 111 sends a start command to the driving mechanism 109, and the driving mechanism 109 is started to drive the transmission shaft 105 to rotate so as to drive the ultrasonic transducer assembly to rotate; the imaging control console 111 transmits pulse signals to the ultrasonic imaging piezoelectric wafer 103, the ultrasonic imaging piezoelectric wafer 103 generates ultrasonic waves, the ultrasonic waves are reflected at different depths in human tissues to form echoes, the echoes are converted into electric signals by the ultrasonic imaging piezoelectric wafer 103 through piezoelectric effect, and the electric signals are transmitted back to the imaging control console 111; the imaging console 111 forms an ultrasonic image from the received signals by an ultrasonic imaging algorithm, and a three-dimensional ultrasonic image of a local target blood vessel can be obtained after imaging.

S306, marking azimuth information of the target ablation area through a three-dimensional ultrasonic image of the target blood vessel, and marking the distance between the target human tissue and the blood vessel wall.

S308, determining an ablation parameter of the ultrasonic ablation piezoelectric wafer 102 in an ablation direction and directional energy according to the received azimuth information and the distance between the target human tissue and the vascular wall by the ablation console 110, then performing ultrasonic ablation by rotating and positioning the ultrasonic ablation piezoelectric wafer one by one, and heating the target human tissue by transmitting high-intensity ultrasonic and continuously using an ultrasonic thermal effect to deactivate the target human tissue so as to realize selective ablation in the circumferential direction.

And S310, after the target ablation area is ablated, performing ultrasonic three-dimensional imaging again, and evaluating the ablation effect.

It should be noted that, in the description of the present specification, the terms "first," "second," and the like are used for descriptive purposes only and to distinguish between similar objects, and there is no order of preference therebetween, nor should it be construed as indicating or implying relative importance. In addition, in the description of the present specification, unless otherwise indicated, the meaning of "a plurality" is two or more.

The foregoing embodiments are merely illustrative of the technical concept and features of the present application, and are intended to enable those skilled in the art to understand the content of the present application and implement the same according to the content of the present application, not to limit the protection scope of the present application. All equivalent changes or modifications made in accordance with the spirit of the present application are intended to be included within the scope of the present application.

It is to be understood that the above description is intended to be illustrative, and not restrictive. Many embodiments and many applications other than the examples provided will be apparent to those of skill in the art upon reading the above description. The disclosures of all articles and references, including patent applications and publications, are incorporated herein by reference for the purpose of completeness.

Claims (9)

1. An ultrasound ablation catheter device comprising a catheter; the method is characterized in that: the device also comprises

An ultrasonic transducer assembly disposed at a distal end of the catheter; the ultrasonic transducer assembly comprises

Ultrasonically ablating the piezoelectric wafer; the front surface of the ultrasonic ablation piezoelectric wafer faces to human tissues and is used for generating sound waves to ablate target human tissues;

an ultrasound imaging piezoelectric wafer; the front surface of the ultrasonic imaging piezoelectric wafer faces to human tissues and is used for generating sound waves to image target human tissues;

a backing; the back lining is shared by the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer and is used for attenuating and absorbing sound waves radiated by the back surface of the ultrasonic ablation piezoelectric wafer and sound waves radiated by the back surface of the ultrasonic imaging piezoelectric wafer;

the ultrasonic transducer assembly is actuatable for rotation to change the direction of acoustic wave radiation of the ultrasonic ablation piezoelectric wafer and the ultrasonic imaging piezoelectric wafer.

2. The apparatus of claim 1, wherein: the back lining is in a flat plate shape and is provided with a first plate surface and a second plate surface which are opposite;

the ultrasonic ablation piezoelectric wafer is positioned on the first plate surface; the ultrasonic imaging piezoelectric wafer is positioned on the second plate surface.

3. The apparatus of claim 1, wherein: the backing is prismatic having at least three prismatic sides;

the ultrasonic imaging piezoelectric wafer is positioned on one of the prism side surfaces; the ultrasound ablation piezoelectric wafer is located on at least one of the remaining prismatic sides thereof.

4. The apparatus of claim 1, wherein: the back lining is cylindrical or circular;

the ultrasonic ablation piezoelectric wafers and the ultrasonic imaging piezoelectric wafers are all arranged on the outer peripheral surface of the backing.

5. The apparatus as claimed in claim 4, wherein: the ultrasonic ablation piezoelectric wafer comprises at least two groups; at least two groups of ultrasonic ablation piezoelectric wafers and ultrasonic imaging piezoelectric wafers are arranged at intervals along the circumferential direction of the peripheral surface of the backing.

6. The apparatus of any one of claims 1-5, wherein: the axial ablation zone of the ultrasonic ablation piezoelectric wafer is located within the axial imaging zone of the ultrasonic imaging piezoelectric wafer.

7. The apparatus of claim 1, wherein: the device also comprises a transmission shaft; the drive shaft is disposed within the conduit and extends in an axial direction of the conduit;

the ultrasonic transducer assembly is arranged at the distal end of the transmission shaft; the proximal end of the drive shaft may be actuated to rotate the ultrasonic transducer assembly.

8. The apparatus of claim 1, wherein: the ultrasonic transducer assembly also comprises a shell wrapping the periphery of the ultrasonic transducer assembly.

9. The apparatus as recited in claim 8, wherein: the guide pipe is provided with a liquid inlet channel and a liquid outlet channel; the liquid inlet channel is communicated with the inner cavity of the shell and is used for inputting cooling liquid into the inner cavity of the shell; the liquid outlet channel is communicated with the inner cavity of the shell and used for discharging cooling liquid in the inner cavity of the shell.

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