CN109512460B

CN109512460B - Phantom for intravascular interventional ultrasonic imaging test

Info

Publication number: CN109512460B
Application number: CN201811649606.2A
Authority: CN
Inventors: 贾旋凯; 李林; 邵小虎; 张鸽; 郑欲晓; 宋亮; 陈丽丽
Original assignee: Insight Lifetech Co Ltd
Current assignee: Insight Lifetech Co Ltd
Priority date: 2018-12-30
Filing date: 2018-12-30
Publication date: 2022-03-08
Anticipated expiration: 2038-12-30
Also published as: CN109512460A

Abstract

The invention relates to a phantom for intravascular interventional ultrasonic imaging test. The phantom comprises: a tissue mimicking layer comprised of a first material; a lumen formed within the tissue mimicking layer for receiving an interventional ultrasound catheter; and a plurality of wire targets composed of a second material, the plurality of wire targets being disposed within the tissue mimicking layer and extending along an elongated direction of the lumen, wherein the first material and the second material differ in ultrasonic properties, and the plurality of wire targets includes a target group distributed in a prescribed pattern on a cross-section of the tissue mimicking layer perpendicular to the elongated direction of the lumen. In the invention, the cavity is arranged in the tissue simulation layer, the line target is arranged in the tissue simulation layer and extends along the extension direction of the cavity, and the tissue simulation layer and the target group have different ultrasonic properties, so that the tissue simulation layer can be used as a phantom to effectively simulate an ultrasonic imaging test, and the imaging effect of the interventional ultrasonic imaging can be effectively evaluated.

Description

Phantom for intravascular interventional ultrasonic imaging test

Technical Field

The invention relates to a phantom for intravascular interventional ultrasonic imaging test.

Background

Interventional ultrasound imaging techniques mainly perform ultrasound imaging on lesions in the body, such as stenoses of blood vessels, under the monitoring or guidance of real-time ultrasound to provide further guidance for interventional therapy. The evaluation of the ultrasonic imaging equipment mainly comprises power detection and image detection. The power detection is mainly the detection of the sound intensity output by the probe, and is measured by an ultrasonic power meter. The image detection mainly comprises a blind area, a longitudinal resolution, a transverse resolution, contrast evaluation and the like, and can be carried out by utilizing a tissue-imitated ultrasonic body model.

Currently, for the traditional B-type ultrasonic diagnostic device (for example, the nominal frequency is in the range of 1.5MHz to 15 MHz), the corresponding national standard such as GB 10152-. In addition, the Chinese food and drug administration also publishes the standard YY/T0937-2014, which stipulates the technical requirements and the measuring method of the ultrasonic tissue-mimicking phantom. Based on these standards, phantoms applied to B-mode ultrasonic diagnostic devices have been extensively studied and matured in the industry. However, compared with the evaluation of the conventional B-ultrasonic imaging, the interventional ultrasonic imaging has the characteristics of higher working frequency, higher spatial resolution, smaller detection depth and the like. Therefore, it is difficult to directly use the phantom of the existing B-mode ultrasonic diagnostic apparatus for evaluation of the phantom for the interventional ultrasonic imaging test.

Disclosure of Invention

The present invention has been made in view of the above-mentioned state of the art, and an object thereof is to provide a phantom for an interventional ultrasound imaging test, which is capable of effectively testing an interventional ultrasound imaging effect.

To this end, the invention provides a phantom for interventional ultrasound imaging testing, comprising: a tissue mimicking layer comprised of a first material; a lumen formed within the tissue mimicking layer for receiving an interventional ultrasound catheter; and a plurality of wire targets composed of a second material, the plurality of wire targets disposed within the tissue-mimicking layer and extending along an elongation direction of the lumen, wherein the first material and the second material differ in ultrasonic properties, and the plurality of wire targets include a target group distributed in a prescribed pattern on a cross-section of the tissue-mimicking layer perpendicular to the elongation direction of the lumen.

In the invention, the cavity is arranged in the tissue simulation layer, the line target is arranged in the tissue simulation layer and extends along the extension direction of the cavity, and the tissue simulation layer and the target group have different ultrasonic properties, so that the tissue simulation layer can be used as a phantom to effectively simulate an ultrasonic imaging test, and the imaging effect of the interventional ultrasonic imaging can be effectively evaluated.

In the phantom according to the present invention, the first material is at least one selected from the group consisting of water, glycerol, agar, alumina, benzalkonium chloride, and silicone carbide. This enables effective simulation of various structures in human tissue.

In the phantom according to the present invention, the second material is at least one selected from the group consisting of stainless steel, nickel titanium, cobalt, chromium, platinum, gold, tungsten, and alloys thereof. In this case, the acoustic impedance of the second material to ultrasound is significant, thereby enabling evaluation of the ultrasound performance as an ultrasound reflection line target.

In the phantom according to the present invention, the second material is at least one selected from the group consisting of nylon, Acrylonitrile Butadiene Styrene (ABS), polyurethane, silicone rubber, polyoxymethylene, and polyetheretherketone. In this case, the acoustic impedance of the second material to ultrasound is significant, thereby enabling evaluation of the ultrasound performance as an ultrasound reflection line target.

In addition, the phantom to which the invention relates optionally comprises at least a first target population for detecting the ultrasound imaging depth. Thereby, the depth of the ultrasound imaging can be detected by the first target group.

In addition, in the phantom according to the present invention, optionally, the target population further comprises a second target population for detecting the geometric position accuracy of the ultrasonic imaging. Thereby, the geometric position accuracy of the ultrasonic imaging can be detected by the second target group.

In addition, in the phantom according to the present invention, the respective line targets of the first target group are optionally spaced apart from the channel in a radial direction of the channel by different distances in a cross section of the tissue-mimicking layer perpendicular to the elongation direction of the channel. In this case, the ultrasonic reaction intensity of the line targets of different depths can be simulated, so that the detection depth, the blind zone, the axial resolution, the lateral resolution, and the like of the ultrasonic imaging can be detected by the first target group.

In the phantom according to the present invention, the respective line targets of the second target group may be arranged in a polygonal region formed by connecting line targets in a cross section of the tissue mimic layer perpendicular to the direction of extension of the cavity. In this case, the degree of deformation of the polygonal region can be simulated, so that the imaging geometric accuracy of the ultrasonic imaging and the like can be detected.

In the phantom according to the present invention, the respective line targets of the first target group are optionally shifted from each other in a radial direction along the channel. In this case, the respective line targets of the first target group do not block each other, whereby the ultrasonic response intensities of the line targets at different depths can be effectively detected.

In addition, in the phantom according to the present invention, optionally, the at least two wire targets of the second target group are spaced apart from the channel in a radial direction of the channel by the same distance in a cross section of the tissue mimic layer perpendicular to the direction of elongation of the channel. In this case, the lateral geometric position accuracy of the ultrasound in the tissue mimicking layer can be effectively detected.

In addition, in the phantom according to the present invention, a region not blocked by the wire target is optionally formed in a radial direction of the tissue mimic layer along the lumen. In this case, the attenuation of the ultrasound in the radial direction of the tissue mimicking layer along the lumen channel can be effectively detected, so that a better ultrasound imaging effect can be obtained by adjusting the ultrasound amplification gain.

According to the invention, the body model for the interventional ultrasonic imaging test can be provided, and the interventional ultrasonic imaging effect can be effectively tested.

Drawings

Fig. 1 is a perspective view showing a phantom for interventional ultrasound imaging test according to an embodiment of the present invention.

Fig. 2 is a schematic view showing a cross section of the phantom according to the present embodiment along the line a-a' of fig. 1.

Fig. 3 is a schematic structural view showing a phantom support according to the present embodiment.

Fig. 4 is a schematic view showing the lumen of the present embodiment having sections with different inner diameters.

Fig. 5 is a schematic diagram showing the distribution of a target group of the line target in fig. 2.

Fig. 6 is a partial schematic view showing the distribution of the line targets in the first target group according to the present embodiment.

Fig. 7 is a partial schematic view showing the distribution of the line targets in the second target group according to the present embodiment.

Fig. 8 is a schematic diagram showing an ultrasonic attenuation detection region according to the present embodiment.

Description of the symbols:

1 … phantom, 11 … tissue mimic, 12 … tract, 13 … wire target, 2 … phantom holder, 21 … cavity, 22 … conduit hole, 23 … threading hole, 131 … first target group, 132 … second target group, 133 … attenuation region.

Detailed Description

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description, the same components are denoted by the same reference numerals, and redundant description thereof is omitted. The drawings are schematic and the ratio of the dimensions of the components and the shapes of the components may be different from the actual ones.

Fig. 1 is a perspective block diagram illustrating an interventional ultrasound imaging test phantom according to an embodiment of the present invention. Fig. 2 is a schematic view showing a cross section of the phantom according to the present embodiment along the a-a' direction of fig. 1. Here, the position of the line a-a' is not particularly limited, and for example, a cross section of the phantom may be taken at any point along the extending direction of the channel 12.

In the present embodiment, a phantom for interventional ultrasound imaging testing (hereinafter sometimes referred to as "phantom") 1 may include a tissue mimic layer 11, a lumen 12, and a wire target 13 (as shown in fig. 1). In the phantom 1 according to the present embodiment, the tissue mimicking layer 11 may be composed of a first material, the channel 12 may be formed in the tissue mimicking layer 11 and adapted to receive an interventional ultrasound catheter, the wire target 13 may be composed of a second material and disposed in the tissue mimicking layer 11 and extending along an elongated direction of the channel 12, and the ultrasound properties of the first material and the second material may be different.

In the phantom 1 according to the present embodiment, the channels 12 are provided in the tissue mimic layer 11, the line targets 13 extend in the direction of extension of the channels 12 provided in the tissue mimic layer 11, and the tissue mimic layer 11 and the line targets 13 have different ultrasonic properties, so that the phantom can effectively simulate an ultrasonic imaging test, and thus can effectively evaluate the imaging effect of the interventional ultrasonic imaging.

In some examples, the phantom 1 may have a rectangular parallelepiped shape in outer shape, in which case the phantom 1 can be easily manufactured on the phantom support 2.

In the present embodiment, the phantom 1 may be arranged in the phantom support 2. Fig. 3 is a schematic structural view showing a phantom support according to the present embodiment. In some examples, as shown in fig. 3, the phantom support 2 may include a mold cavity 21, a conduit hole 22, and a threading hole 23. The phantom holder 2 shown in fig. 3 can be used to manufacture, for example, a rectangular parallelepiped phantom 1.

Wherein the mold cavity 21 of the phantom support 2 may be a cavity with an opening for receiving the tissue mimicking layer 11. In addition, the conduit holes 22 of the phantom support 2 may cooperate with the channels 12 of the phantom 1, forming, for example, a connection passage through the phantom 1. In some examples, the phantom support 2 may have a conduit hole 22 on only one side, in which case the conduit hole 22 through that side may mate with the channel 12 of the phantom 1. In addition, the threading holes 23 may be used to pass through and fix the thread targets 13 of the phantom 1.

In some examples, one end of the wire target 13 may be fixed on one face of the phantom support 2, and the other end of the wire target 13 is fixed on the other face of the phantom support 2 after passing through the wire passing hole 23. In some examples, the wire target 13 may remain in tension. Here, the line targets 13 may be plural, and for convenience of representation, the line targets 13 may refer to plural line targets. In some examples, the plurality of wire targets includes a target population distributed in a prescribed pattern on a cross-section of the tissue mimicking layer perpendicular to an elongation direction of the lumen.

In some examples, the threading hole 23 may be circular in shape. In other examples, the threading holes 23 may be oval, rectangular, or irregular. In some examples, the threading aperture 23 can also accommodate two or more thread targets 13, thereby facilitating testing of axial and lateral resolution of ultrasound imaging.

The phantom 1 according to the present embodiment may be used for testing the effect of an interventional ultrasound instrument, such as an interventional ultrasound catheter, in intravascular ultrasound imaging. Specifically, the phantom 1 is placed in the phantom holder 2, and then the interventional ultrasound catheter is inserted into the lumen 12 along the lumen 12 of the phantom 1, and the lumen 12, the surrounding tissue-mimicking layer 11, and the line target 13 are ultrasonically imaged by the interventional ultrasound catheter, thereby evaluating the imaging effect of the ultrasonic imaging by the interventional ultrasound catheter.

In this embodiment, the tissue mimicking layer 11 may be composed of the first material. In some examples, the first material may be a material having acoustic impedance to ultrasound. In some examples, the first material may be a mixture of water, glycerol or agar and at least one selected from alumina, algaecide, silicone carbide. This enables effective simulation of various structures in human tissue.

In some examples, the first material may include water, glycerol, agar, alumina, algaecide, and silicone carbide. In some examples, the mass ratio of glycerol, agar, and alumina in the first material may be 10:3: 2. In some examples, the mass ratio of water, glycerol, agar, alumina, algaecide, silicone carbide in the first material may be 160:20:6:4:1: 1. In some examples, the water contained by the first material may be purified water produced from drinking water by distillation, ion exchange, reverse osmosis, or other suitable methods. Thereby, the influence of unnecessary impurities on the physicochemical properties or ultrasonic properties of the texture simulation layer 11 can be reduced.

In the present embodiment, the use of agar as the first material improves the process for producing the tissue-mimicking layer 11, and increases the proximity of the ultrasonic properties of the tissue-mimicking layer 11 to human tissue. In particular, agar is gel-like at 40 ℃ or less, and agar can have ultrasound properties close to those of human tissues.

In this embodiment, glycerol may be used in the first material to increase the bonding force of the components to each other. Thereby, the physicochemical properties and the stability of the ultrasonic properties of the tissue mimic layer 11 can be further improved.

In the present embodiment, alumina or silicone carbide may be used as the ultrasonic attenuation powder in the first material to adjust the degree of intensity of ultrasonic scattering or reflection. In some examples, the particles of alumina or silicone carbide as the ultrasound attenuating powder may have a particle size of 0.3 to 3 microns. In this case, the ultrasound properties of the tissue mimic layer 11 can be adjusted, thereby enabling an improved imaging effect of the phantom 1.

In some examples, the use of the algicidal amine in the first material may have bactericidal and algicidal capabilities. This can further prolong the service life of the tissue simulation layer 11.

Additionally, in some examples, the acoustic impedance of the first material may be 1 × 10⁶kg/(m²s) to 2X 10⁶kg/(m²s). In some examples, the acoustic attenuation coefficient slope of the first material can be 0.4 ° dB/(cm · MHz) to 0.8 ° dB/(cm · MHz). In this case, the ultrasound properties of the first material may be closer to the human tissue structure, and the ultrasound properties of the tissue structure of the human body, such as the blood vessel wall and the surrounding tissue structure, can be effectively simulated, thereby being able to serve as a test background for detecting the ultrasound reaction of the line target 13.

In this embodiment, the tissue mimicking layer 11 may be formed by infusing a first material into the phantom support 2. In particular, the first material may be poured into the mold cavity 21 of the phantom support 2, into a massive tissue-mimicking layer 11 after the first material has cured. In some examples, the tissue mimicking layer 11 may be rectangular parallelepiped in shape. The rectangular parallelepiped has a length of 50mm, a height of 45mm, and a thickness (the direction of extension of the channel 12) of 45mm, for example. However, the present embodiment is not limited thereto, and the first material may constitute the tissue mimic layer 11 in a volume of other size or a shape other than a rectangular parallelepiped, such as a cylinder, a prism, or other irregular shape.

In some examples, the first material may be heated to about 90 ℃ with stirring, held for about 1 hour, cooled to about 45 ℃ naturally, and poured into the mold cavity 21 to be naturally coagulated and molded when the tissue-mimicking layer 11 is prepared. In this case, the compositional uniformity and structural strength of the tissue mimic layer 11 can be improved, thereby enabling an increase in the reuse efficiency of the phantom 1.

In this embodiment, the tissue mimicking layer 11 may be stored in a sealed container containing a phantom maintenance fluid and maintained at a storage temperature of 10 ℃ to 35 ℃. In some examples, the phantom maintenance fluid may be a mixture of purified water and silicone oil. In this case, the physicochemical properties and the ultrasonic properties of the tissue mimic layer 11 are maintained, whereby the number of repeated uses of the tissue mimic layer 11 can be increased, and the service life of the tissue mimic layer 11 can be prolonged.

In this embodiment, the channels 12 may be disposed within the tissue mimicking layer 11. The channels 12 may extend through the tissue mimicking layer 11. This makes it possible to effectively simulate, for example, blood vessels of human tissue by the lumen 12 in the tissue simulation layer 11.

Additionally, in some examples, the lumen 12 may be disposed at the geometric center of the tissue mimicking layer 11. In this case, more test line targets 13 may be disposed around the channels 12 in the tissue simulation layer 11, which is advantageous for improving the utilization rate of the tissue simulation layer 11.

In some examples, the lumen 12 may extend linearly through the entire tissue mimicking layer 11. In this case, the lumen 12 may provide space for the interventional ultrasound catheter to be inserted, rotated, and withdrawn, thereby enabling the ultrasound catheter to test the imaging effect of the wire target 13.

In some examples, the shape of the channel 12 in a cross-section perpendicular to its direction of extension may be circular-hole-like (as shown in fig. 2). In some examples, the inner diameter of the circular hole may be less than or equal to 3 mm. The present embodiment is not limited thereto, and in some examples, the shape of the channel 12 in a cross section perpendicular to the extending direction thereof may be other shapes, such as a rectangular shape, a polygonal shape, and the like.

In some examples, the inner walls of the channels 12 formed in the tissue mimicking layer 11 may be smooth and dense. In this case, when performing an ultrasound imaging test using the interventional ultrasound catheter, the tissue mimicking layer 11 can be reduced from being damaged upon movement of the interventional ultrasound catheter inside the lumen 12, whereby the number of reuses of the phantom 1 can be increased.

In some examples, the lumen 12 may be divided into a plurality of sections of different inner diameters. For example, the channels 12 may be divided into

channels

12a, 12b, and 12c (see fig. 4). That is, the

channels

12a, 12b, and 12c may constitute the channels 12. In the example of FIG. 4, inner diameter d1 of channel 12a is less than inner diameter d2 of channel 12b, and inner diameter d2 of channel 12b is less than inner diameter d3 of channel 12 c. In this case, the effect of different ultrasound imaging can be tested according to the sections of different inner diameters of the lumen 12.

In some examples, the lumen 12 may be filled with a phantom maintenance fluid for coupling the ultrasound catheter and the tissue mimicking layer prior to testing. In some examples, the phantom maintenance fluid may be a mixture of purified water and silicone oil. In this case, on the one hand, air remaining in the lumen 12 when the ultrasound catheter is inserted during test ultrasound imaging can be reduced, and on the other hand, the air can be used as a coupling liquid between the ultrasound transducer and the tissue simulation layer 11 in the ultrasound catheter, thereby reducing the false detection rate and improving the test efficiency.

In some examples, in manufacturing the channels 12 in the tissue simulation layer 11, the channels 12 can be obtained by inserting a columnar mold into the guide holes 22 of the phantom support 2 and holding it still, pouring the first material into the cavity 21 of the phantom support 2, solidifying it, and then pulling out the columnar mold. In other examples, the channels 12 may not extend through the entire tissue mimicking layer 11. Specifically, within the tissue mimicking layer 11, the lumen 12 may extend from a side within the tissue mimicking layer 11 into the tissue mimicking layer 11 without penetrating through the tissue mimicking layer 11.

In other examples, the elongate direction of the channels 12 may also be other than straight. For example, the channels 12 may be formed in the tissue mimicking layer 11 along a curved curve. In this way, the true situation of a blood vessel within a tissue can be more closely simulated.

In the present embodiment, the wire target 13 may be composed of the second material. In some examples, as described above, the ultrasonic properties of the first material and the second material may be different. In some examples, the acoustic impedance of the first material may be less than the acoustic impedance of the second material.

In some examples, the line target 13 may have a certain thickness. For example, the wire target 13 may have a diameter of 1 to 50 microns. In some examples, the shape of the wire target 13 in a cross section perpendicular to the extending direction thereof may be a circular shape.

In some examples, the second material comprising the wire target 13 may be selected from at least one of stainless steel, nickel titanium, cobalt, chromium, platinum, gold, tungsten, and alloys thereof. In some examples, the wire target 13 may be a tungsten wire having a diameter of 1 to 50 microns.

In other examples, the second material may be at least one of nylon, Acrylonitrile Butadiene Styrene (ABS), polyurethane, silicone rubber, polyoxymethylene, polyetheretherketone. In some examples, the second material may be nylon filaments having a diameter of 20 to 30 microns.

In some examples, the acoustic impedance of the second material may be 80 x 10⁶kg/(m²s) to 110X 10⁶kg/(m²s). In this case, the acoustic impedance of the second material is larger than that of the first material, thereby enabling the position of the line target 13 to be identified when the ultrasonic beam propagates in the tissue mimicking layer 11.

In the present embodiment, for example, when an ultrasonic beam emitted from an ultrasonic transducer hits a line target 13, reflection occurs, and the reflected ultrasonic wave is received by the ultrasonic transducer and displayed as a dot of a different color, for example, white, on an image imaged by the ultrasonic transducer, whereby the reflection state of the ultrasonic beam can be recognized.

In the present embodiment, the portion of the wire target 13 buried in the tissue simulation layer 11 may be linear. In some examples, the line target 13 may be substantially parallel to a centerline of the channel 12. For example, when the channel 12 is substantially linear, the line target 13 may be substantially linear along the extension direction of the channel 12. For example, when the channel 12 is substantially curved, the line target 13 may be substantially curved along the direction in which the channel 12 extends. In this case, the variation of the distance between the line target 13 and the channel 12 in the extending direction of the channel 12 can be improved, thereby being capable of reducing the influence of the variation of the depth of the interventional ultrasonic catheter inserted into the channel 12 on the detection of the ultrasonic imaging effect.

In this embodiment, the thread target 13 can be fixed to the thread hole on the phantom support 2. Specifically, the thread target 13 may pass through two coaxial thread holes 23 on the phantom support 2 and both ends thereof may be fixed on the phantom support 2. In some examples, the wire target 13 may remain in a stressed state. In this case, the position of the thread target 13 is defined by the thread passing hole 23, whereby the positional accuracy of the thread target 13 can be improved, thereby improving the test stability of the phantom 1 and increasing the number of times of reuse of the phantom 1.

In some examples, when the phantom 1 according to the present embodiment is manufactured, the wire targets 13 may be fixed to the phantom support 2 and kept in a tense (e.g., straight) state, and then the first material may be poured into the cavity 21 of the phantom support 2 to be coagulated and molded. In this case, the line target 13 is embedded closely in the first material, whereby it is possible to reduce the gap between the line target 13 and the first material and to reduce the false detection rate.

Fig. 5 is a schematic diagram showing the distribution of a target group of the line target in fig. 2. In fig. 5, the imaginary line of the range of the target group is increased for the sake of explanation. Fig. 6 is a partial schematic view showing the distribution of the line targets in the first target group according to the present embodiment. In fig. 6, imaginary lines of concentric circles and imaginary lines of lines connecting the target and the center of the channel are added for the sake of illustration.

In the present embodiment, the number of the line targets 13 may be plural. In the present embodiment, at least the first target group 131 (shown in fig. 5) for detecting the ultrasonic imaging depth may be divided among the plurality of line targets 13. In some examples, the first target group 131 may have, for example, 5 to 10 line targets 13.

In some examples, on a cross section of the tissue mimic layer 11 perpendicular to the elongation direction of the channel 12, the respective line targets 13 of the first target group 131 are at different distances from the channel 12 in the radial direction of the channel 12, and the respective line target(s) 13 of the first target group 131 are offset from each other in the radial direction along the channel 12 (see fig. 6).

In some examples, the first target population 131 may be distributed in a prescribed pattern P1 on a cross-section of the tissue mimicking layer 11 perpendicular to the elongated direction of the lumen 12. For example, the predetermined pattern P1 may be a curve formed by connecting the respective line targets 13.

In the example of fig. 6, there are 9 line targets 13 of the first target group 131. In some examples, the distance from the center point o of the channel 12 may be different, for example, the distance from each line target 13 to the center point o of the channel 12 is 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, respectively.

In some examples, the angle between the connecting line of the adjacent line targets 13 of the first target group 131 and the center of the channel 12 may be less than 90 degrees. For example, referring to fig. 6 as an example, a connection line L1 between the line targets 1311 and 13) and the center point o forms an included angle θ with a connection line L2 between the line targets 1312 and 13 and the center point o, taking the center point o of the channel 12 as a center. In some examples, the included angle θ may be 12 °.

In other examples, the connecting lines between the adjacent line targets 13 and the center of the channel 12 may form the same angle. In this case, the line target 13 farther from the lumen 12 is not blocked by the closer line target 13, and the interventional ultrasound catheter can detect the ultrasound reaction intensity of the line targets 13 of different depths, thereby being capable of detecting the detection depth, the blind zone, the axial resolution, the lateral resolution, and the like of the interventional ultrasound catheter.

In some examples, in an ultrasound imaging test, the ultrasound transducer of the ultrasound catheter may be aligned with the first target group 131, the closest target line 13 where the image can be resolved is found, and the distance between the target line 13 and the center of the lumen 12 is recorded. Thereby, the blind area of the ultrasonic catheter can be evaluated.

In some examples, during the ultrasound imaging test, the ultrasound transducer of the ultrasound catheter may be aligned with the first target group 131, the farthest target line 13 from which the image can be resolved is found, and the distance between the target line 13 and the center of the lumen 12 is recorded. Thereby, the probe depth of the ultrasound catheter can be evaluated.

In some examples, at the time of ultrasonic imaging testing, another line target 13 may be placed beside a certain line target 13 of the first target group 131 in a direction along the radial direction, and the distance between the two may be adjusted while keeping both identifiable by ultrasonic imaging, and the adjustable minimum distance between the two may be recorded. Thereby, the axial resolution of the ultrasound catheter at the depth can be evaluated.

In some examples, at the time of ultrasonic imaging testing, another line target 13 may be placed beside a certain line target 13 of the first target group 131 in a direction perpendicular to the radial direction, and the distance between the two may be adjusted while keeping both identifiable by ultrasonic imaging, and the adjustable minimum distance between the two may be recorded. Thereby, the lateral resolution of the ultrasound catheter at the depth can be evaluated.

In some examples, the calculation method of the indexes of the detection depth, the blind zone, the axial resolution and the lateral resolution of the ultrasonic imaging may refer to the national standard GB 10152-.

Fig. 7 is a partial schematic view showing the distribution of the line targets in the second target group according to the present embodiment. In fig. 7, imaginary lines of concentric circles and imaginary lines of a connecting line between the line target and the line target are added for the sake of explanation.

In this embodiment, the plurality of line targets 13 further includes a second target group 132 (shown in fig. 7) for detecting the geometric position accuracy of the ultrasonic imaging. In some examples, the second target population 132 may be distributed in a prescribed pattern P2 on a cross-section of the tissue mimicking layer 11 perpendicular to the elongated direction of the lumen 12. The predetermined pattern P2 may be, for example, a polygonal region (described later) in which the respective line targets 13 are connected.

In some examples, the second target group 132 may have 4 to 10 line targets 13.

In some examples, the respective wire targets 13 of the second target group 132 are arranged in a connected polygonal region on a cross section of the tissue simulation layer 11 perpendicular to the extending direction of the lumen 12. In this case, the interventional ultrasound catheter can detect the deformation degree of the polygon during the ultrasound imaging test, thereby being capable of detecting the imaging geometric accuracy of the interventional ultrasound catheter, including but not limited to the longitudinal geometric position accuracy, the transverse geometric position accuracy and the image geometric distortion.

In some examples, a polygon formed by the distribution of the respective line targets 13 of the second target group 132 (an imaginary polygon formed by connecting points of the respective line targets 13) may be at least one of a rectangle, a trapezoid, and a pentagon.

In some examples, the distribution of the line targets 13 of the second target group 132 may form a pattern comprising two or more polygons at different distances from the center point o of the channel 12, thereby enabling detection of the imaging geometry accuracy of the interventional ultrasound catheter at different depths.

In some examples, the pattern formed by the distribution of the line targets 13 of the second target group 132 may include two isosceles trapezoids having different distances from the center point o of the channel 12. In some examples, the pattern formed by the distribution of the line targets 13 of the second target group 132 may include two isosceles trapezoids, wherein the end points (line targets 13) of the bases (upper or lower bases) of the two isosceles trapezoids are at the same distance from the center point o of the channel 12. In other examples, the pattern formed by the distribution of the second target group 132 may include two isosceles trapezoids, wherein the distance between the two nearest bases in the two isosceles trapezoids may be 2mm to 5 mm.

In some examples, the line targets 13 of the second target group 132 appear as white dots on the ultrasound imaged image.

In some examples, the distance from the vertex of the trapezoid formed by the distribution of the line targets 13 of the second target group 132 to the center point o of the channel 12 is used as a reference, the variation degree of the distance from the vertex of the corresponding trapezoid to the center of the channel 12 in the ultrasonic imaging is calculated, and the longitudinal geometric position accuracy of the position of the vertex of the trapezoid can be obtained.

In some examples, the length of the side of the base of the trapezoid formed by the distribution of the line targets 13 of the second target group 132 is used as a reference, and the degree of variation of the length of the side of the base of the corresponding trapezoid in the imaging is calculated, so that the transverse geometric position accuracy of the position of the vertex of the base of the trapezoid can be obtained.

In some examples, the degree of variation of the four side lengths and the two diagonal lines of the trapezoid formed by the distribution of the line targets 13 of the second target group 132 is calculated with reference to the four side lengths and the two diagonal lines of the trapezoid in the imaging, and the maximum value of the variation is taken, so as to obtain the image geometric distortion of the trapezoid.

In some examples, the calculation method of the longitudinal geometric position accuracy and the transverse geometric position accuracy of the ultrasonic imaging may refer to the national standard GB 10152-2009 issued by the chinese national standards committee.

Fig. 8 is a schematic diagram showing an ultrasonic attenuation detection region according to the present embodiment. In fig. 8, to help explain the distribution characteristics of the ultrasonic attenuation detection region, an imaginary line of a fan-shaped side line is added.

In the present embodiment, in the radial direction of the tissue mimic layer 11 along the lumen 12, an attenuation region 133 (shown in fig. 8) which is a region not blocked by the line target 13 may be formed. In this case, the interventional ultrasound catheter can detect the attenuation of the ultrasound in the tissue mimic layer 11 along the depth direction during the ultrasound imaging test, so that the ultrasound amplification gain can be adjusted for better imaging effect.

In some examples, adjusting the ultrasound amplification gain to use a larger gain farther from the channel 12 and a smaller gain closer to the channel 12 may achieve an ultrasound imaging effect with consistent image brightness. This can reduce the probability that a lesion is missed in recognition due to too dark images or a non-lesion is erroneously recognized as a lesion due to too bright images.

In some examples, the attenuation region 133 may be a sector-shaped region centered at the center point o of the channel 12. In some examples, the attenuated region 133 may be a sector of 90 to 150 degrees.

In addition, in some examples, by adjusting the position of the line targets 13, or adjusting the mutual positional relationship of the first target group 131 and the second target group 132, the distribution of the line targets 13 can be made dense, in which case the range of the fan-shaped region of the attenuation region 133 can be increased. Thus, the efficiency of adjusting the ultrasonic amplification gain can be improved.

While the invention has been described in detail in connection with the drawings and the embodiments, it is to be understood that the above description is not intended to limit the invention in any way. Those skilled in the art can make modifications and variations to the present invention as needed without departing from the true spirit and scope of the invention, and such modifications and variations are within the scope of the invention.

Claims

1. A phantom for intravascular interventional ultrasonic imaging test is characterized in that:

the method comprises the following steps:

a tissue mimicking layer comprised of a first material, the tissue mimicking layer mimicking a vessel wall and surrounding tissue structure;

a lumen formed within the tissue mimicking layer for receiving an interventional ultrasound catheter;

a plurality of wire targets comprised of a second material, the plurality of wire targets disposed within the tissue mimicking layer and extending along an elongation of the lumen; and

a phantom support which comprises a mold cavity, a conduit hole and a threading hole, wherein the mold cavity is used for accommodating the tissue imitating layer, the conduit hole is matched with the cavity channel to form a communication area, the threading hole is used for penetrating and fixing the thread target, one end of the thread target is fixed on one surface of the phantom support, and the other end of the thread target is fixed on the other surface of the phantom support after penetrating through the threading hole,

wherein the first material and the second material have different ultrasonic properties, and the plurality of line targets include target groups distributed in a predetermined pattern on a cross section of the tissue simulation layer perpendicular to the direction of elongation of the channel, the line targets include a plurality of line targets, and the plurality of line targets include at least a first target group for detecting a depth of ultrasonic imaging and a second target group for detecting a geometric position accuracy of ultrasonic imaging, wherein the line targets of the first target group are staggered from each other in a radial direction along the channel, and the line targets of the second target group are arranged in a connected polygonal region including a first isosceles trapezoid whose upper or lower end is the same distance from a center point of the channel on the cross section of the tissue simulation layer perpendicular to the direction of elongation of the channel, and the end points of the upper base line and the lower base line of the first isosceles trapezoid are staggered with each other in the radial direction along the cavity channel.

2. The phantom according to claim 1, characterized in that:

the first material is at least one selected from water, glycerol, agar, aluminum oxide, algaecide and silicon carbide.

3. The phantom according to claim 1, characterized in that:

the second material is selected from at least one of stainless steel, nickel titanium, cobalt, chromium, platinum, gold, tungsten, and alloys thereof.

4. The phantom according to claim 1, characterized in that:

each line target of the first target group is at a different distance from the lumen in a radial direction of the lumen on a cross section of the tissue mimicking layer perpendicular to an elongation direction of the lumen.

5. The phantom according to claim 1, characterized in that:

in a radial direction of the tissue mimicking layer along the lumen, a region not blocked by the wire target is formed.