Mini-array controllable helical deformation ICE catheter and imaging range expansion method

Abstract

The application discloses an ICE catheter with controllable micro-array spiral deformation and an imaging range expansion method. A hollow acoustic window structure is arranged at the distal end of a sheath tube of the ICE catheter, which is used to fill an acoustic coupling medium of liquid. A supporting assembly, a power assembly, a micro-transducer linear array and a traction member are connected in the hollow acoustic window structure. The supporting assembly is arranged along the axial direction of the sheath tube. The micro-transducer linear array comprises a plurality of rotatable transducer elements arranged on the supporting assembly along the axial direction of the sheath tube in sequence. Each transducer element has a piezoelectric layer perpendicular to the axial direction of the sheath tube. The traction member is connected to the plurality of transducer elements in sequence and is eccentrically connected to the transducer elements. The output end of the power assembly is drivingly connected to the traction member and can drive the traction member to swing. The traction member drives at least part of the transducer elements of the micro-transducer linear array to rotate asynchronously to arrange the transducer elements in a spiral shape. In the dynamic field of view, clear image quality can be achieved, and the requirement for bending the sheath tube can be reduced.

Description

Technical Field

[0001] This application relates to the field of minimally invasive interventional device technology, and more specifically, to an ICE catheter with microarray controllable helical deformation and a method for expanding the imaging range. Background Technology

[0002] Intracardiac ultrasound imaging (ICE) is a minimally invasive interventional imaging technique that uses a miniature ultrasound catheter inserted deep into the heart through a blood vessel to create an image. Compared to traditional transthoracic ultrasound (TTE) and transesophageal ultrasound (TEE), ICE often has higher image resolution and higher image quality.

[0003] ICE catheters allow for the observation and diagnosis of diseased structures from inside the heart, thus placing higher demands on the imaging field of view and range. This means that precise detection of target areas from inside the heart is required through the manipulation of the ICE catheter.

[0004] To meet imaging requirements, given that catheter size is limited by blood vessel diameter, ICE catheters typically consist of a micro transducer array and a multi-directionally adjustable curved sheath. The micro transducer array is located at the distal end of the catheter. During use, the micro transducer array is delivered into the heart through the catheter. Then, the orientation of the distal end of the multi-directionally adjustable curved sheath is adjusted to select the imaging angle and direction. After determining the final imaging position, the orientation of the distal end of the multi-directionally adjustable curved sheath is mechanically locked, and then local imaging is performed.

[0005] However, because the microarray transducer array is located at the distal end of the adjustable bend sheath, the actual imaging field of view and angle of the current ICE catheter remains fixed. Although this helps to ensure stable and reliable image quality, it also limits the clinical diagnostic scenarios. Furthermore, the spatial layout of the internal structure at the distal end of the adjustable bend sheath is tight, making it difficult to find the optimal imaging section. Consequently, the steering control within the imaging section is difficult to adjust with fine precision through the adjustable bend sheath.

[0006] In summary, how to provide an ICE catheter with a wide imaging field of view that can overcome the over-reliance on adjustable bending sheaths for attitude adjustment is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0007] In view of this, the purpose of this application is to provide a microarray controllable helical deformation ICE catheter and an imaging range expansion method that can achieve clear image quality within a dynamic field of view while reducing the need for sheath bending.

[0008] To achieve the above objectives, this application provides the following technical solution:

[0009] An ICE catheter with microarray controllable helical deformation, comprising:

[0010] The sheath has a hollow acoustic window structure at its distal end. The hollow acoustic window structure is used to fill a liquid acoustic coupling medium. A support component, a power component, a linear array of micro transducers, and a traction component are connected inside the hollow acoustic window structure. The support component is arranged along the axial direction of the sheath.

[0011] The micro transducer linear array includes multiple transducer elements, each of which has a piezoelectric layer perpendicular to the sheath axis. The multiple transducer elements are rotatably mounted on the support assembly and arranged sequentially along the sheath axis.

[0012] The traction component sequentially connects to multiple transducer array elements and is eccentrically connected to the transducer array elements.

[0013] The output end of the power component is connected to the traction member and can drive the traction member to swing. The traction member drives at least a portion of the transducer array elements of the micro transducer linear array to rotate asynchronously and arrange them in a spiral shape.

[0014] Preferably, the transducer array element includes a matching layer, an electrode layer, a piezoelectric layer, a circuit layer and a backing layer arranged in sequence along the radial direction of the sheath. The backing layer has a positioning hole at the middle position along the width direction of the transducer array element, and the backing layer also has a transmission hole along the width direction of the transducer array element. The transmission hole is offset from the positioning hole.

[0015] The support assembly includes a positioning shaft connected to the positioning hole of the transducer array element; the traction member is connected to the transmission hole of the transducer array element.

[0016] Preferably, the power assembly includes a power element one, which is connected to at least one of the distal and proximal ends of the micro-transducer linear array via the traction element, to adjust the micro-transducer linear array to at least partially form a helical array configuration; and / or,

[0017] The power assembly also includes a second power component, which is connected to the proximal or distal end of the positioning shaft to drive the entire linear array of micro transducers to rotate circumferentially.

[0018] Preferably, the power assembly further includes a first truss and a second truss sleeved on the positioning shaft;

[0019] The first truss is located at the far end of the linear array of micro transducers, and the second truss is located at the near end of the linear array of micro transducers.

[0020] The two ends of the traction component are respectively fixedly connected to the first truss and the second truss;

[0021] The output end of the power component one is connected to the truss one and / or the truss two to rotate relative to the positioning axis.

[0022] Preferably, the support assembly further includes a positioning sleeve one and a positioning sleeve two, both of which are sleeved on the outside of the positioning shaft. The positioning sleeve one is located on the side of the truss one away from the micro transducer linear array and abuts against the truss one. The positioning sleeve two is located on the side of the truss two away from the micro transducer linear array and abuts against the truss two.

[0023] And / or, the traction member includes a traction wire body and a plurality of fixed sections, the plurality of fixed sections being arranged sequentially along the axial direction of the traction wire body, and the plurality of fixed sections being interference-fitted into or connected by entanglement to the transmission hole corresponding to the transducer array element.

[0024] Preferably, the power assembly further includes a spring tube, which is movably sleeved on the outside of the positioning shaft. The positioning holes of the transducer array element are connected to the spring tube, and the pitch at both ends of the spring tube is greater than the pitch of the middle tube section.

[0025] Preferably, the distance between the transmission hole and the positioning hole of each transducer element is gradually varied, and the distance between the transmission hole and the positioning hole decreases as the distance between the transducer element and the power component increases.

[0026] Preferably, adjacent transducer elements are spaced apart and each has a movable gap; or,

[0027] There are movable gaps between the matching layers, electrode layers, piezoelectric layers and circuit layers of adjacent transducer array elements, and the backing layers of several transducer array elements are connected into an integral structure, and the backing layer is a layer structure that can elastically deform.

[0028] Preferably, the traction element includes a traction wire one and a traction wire two, and the transmission hole includes a transmission hole one and a transmission hole two. The transmission hole one and the transmission hole two are symmetrically arranged on both sides of the positioning hole. The traction wire one passes through the transmission hole one of the plurality of transducer array elements, and the traction wire two passes through the transmission hole two of the plurality of transducer array elements.

[0029] An imaging range extension method, applied to the ICE catheter with microarray controllable helical deformation as described in any one of the above claims, the method comprising:

[0030] The power component is activated, causing some of the transducer elements of the linear array of micro transducers to gradually twist into a spiral array shape, and dynamic two-dimensional image frames and corresponding spatial pose data are collected.

[0031] The two-dimensional image frame and the spatial pose data are processed synchronously, and the data are interpolated and fused in a preset voxel coordinate system through a three-dimensional reconstruction algorithm to generate a continuous three-dimensional volumetric image of the target area.

[0032] Preferably, the micro transducer linear array includes a far-end sub-array, a near-end sub-array, and an intermediate sub-array, and each of the far-end sub-array, the near-end sub-array, and the intermediate sub-array includes a plurality of the transducer array elements;

[0033] The image formed by scanning a plurality of transducer elements in the far-end sub-array is the far-end imaging plane, the image formed by scanning a plurality of transducer elements in the near-end sub-array is the near-end imaging plane, and the image formed by scanning a plurality of transducer elements in the middle sub-array is the middle imaging plane.

[0034] The collection of dynamic two-dimensional image frames includes:

[0035] Based on the helical twist angle of the linear array of the micro transducers, the number of excitations for the transducer elements in the far-end sub-array, the near-end sub-array, and the middle sub-array is determined.

[0036] The transducer array elements in the far-end sub-array, the near-end sub-array, and the intermediate sub-array are excited according to the number of excitations;

[0037] The method for determining the number of excitations corresponding to the far-end subarray, the near-end subarray, and the intermediate subarray is as follows:

[0038] Excite a corresponding number of transducer elements in the far-end subarray, the near-end subarray, or the intermediate subarray such that the scanning range of the corresponding subarray is greater than or equal to the helical twist angle.

[0039] In the ICE conduit with controllable helical deformation of microarray provided by the present invention, the distal structure of the sheath is a hollow acoustic window structure. The hollow acoustic window structure is the hollow tube segment at the distal end of the sheath that is sound-transmitting (generally refers to the part that can transmit ultrasound waves) to meet the requirements of linear array scanning imaging of micro transducers. To ensure good sound transmission effect, the hollow acoustic window structure is filled with a liquid phase acoustic coupling medium, and the inner cavity of the hollow acoustic window structure is also used to accommodate the linear array of micro transducers as well as the support components, power components and traction components that support and drive its movement.

[0040] The beneficial effects are as follows: each transducer element has a piezoelectric layer perpendicular to the sheath axis, which enables scanning. Several transducer elements are arranged sequentially along the axis of the hollow acoustic window structure to form a micro transducer linear array, which can achieve sub-aperture scanning at different positions to obtain 2D sub-imaging. Each transducer element in the micro transducer linear array is set on a support component arranged along the axis of the sheath, and can rotate around the center line extending along the axis of the hollow acoustic window structure. Correspondingly, the traction component passes through each transducer element arranged along the axis of the hollow acoustic window structure in sequence, and the traction component is connected to the non-rotation center position of each transducer element. Correspondingly, the output end of the power component is connected to the end of the traction component, so that several transducer elements are driven to rotate around the axis of the hollow acoustic window structure through the traction component.

[0041] When the traction component drives several transducer array elements to rotate, the traction component is connected to the first end of the power component and is driven to rotate directly. The second end of the traction component is driven to rotate passively by the pulling action generated by the power transmitted by the traction component itself. That is, the second end rotates under the drive of the first end. The rotation of the second end of the traction component has a lag. When the power component drives the transducer array elements to rotate through the traction component, the linear array of miniature transducers composed of several transducer array elements presents a spiral array shape. Thus, the ICE catheter of this application can not only adjust the spiral torsion angle in real time according to the needs to achieve clear image quality in the dynamic field of view, but also reduce the need for sheath bending. Attached Figure Description

[0042] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0043] Figure 1 A schematic diagram of the adjustment state of the distal end of the sheath in a specific embodiment of the present invention;

[0044] Figure 2 An oblique projection diagram of the array single-end adjustment structure provided in a specific embodiment of the present invention;

[0045] Figure 3 This is a front view of the array single-end adjustment structure provided in a specific embodiment of the present invention;

[0046] Figure 4 A partial structural schematic diagram of the array single-end adjustment structure provided in a specific embodiment of the present invention;

[0047] Figure 5This is another partial structural schematic diagram of the array single-end adjustment structure provided in a specific embodiment of the present invention;

[0048] Figure 6 This is a schematic diagram of the control method for the array single-end adjustment structure provided in a specific embodiment of the present invention.

[0049] Figure 7 A schematic diagram of the transducer array element distribution state of the array single-end adjustment structure provided in a specific embodiment of the present invention;

[0050] Figure 8 An oblique projection diagram of the array dual-end adjustment structure provided in a specific embodiment of the present invention;

[0051] Figure 9 This is a front view of the array double-ended adjustment structure provided in a specific embodiment of the present invention;

[0052] Figure 10 This is a schematic diagram of the control method for the array dual-end adjustment structure provided in a specific embodiment of the present invention;

[0053] Figure 11 The oblique projection diagram shows the array single-end adjustment and overall array position adjustable structure provided in a specific embodiment of the present invention.

[0054] Figure 12 The image shows a front view of a structure where the array can be adjusted at one end and the overall position of the array can be adjusted, according to a specific embodiment of the present invention.

[0055] Figure 13 A schematic diagram illustrating the control method for a single-end adjustable array structure with an overall adjustable array position, provided in a specific embodiment of the present invention.

[0056] Figure 14 The oblique projection diagram of the array non-uniform angle adjustment structure provided in a specific embodiment of the present invention;

[0057] Figure 15 A schematic diagram of the transducer element distribution state of the array non-uniform angle adjustment structure provided in a specific embodiment of the present invention;

[0058] Figure 16 A side view of the independent structure of transducer elements in a micro transducer linear array according to a specific embodiment of the present invention;

[0059] Figure 17 A side view of the interconnected structure of transducer elements in a micro transducer linear array according to a specific embodiment of the present invention;

[0060] Figure 18 A front view of a transducer array element provided in a specific embodiment of the present invention;

[0061] Figure 19 This is a schematic diagram of the structure of traction wire one and traction wire two in a specific embodiment of the present invention.

[0062] The reference numerals in the figures include:

[0063] 1-Sheath; 11-Hollow acoustic window structure;

[0064] 2-Linear array of miniature transducers; 21-Transducer element; 211-Matching layer; 212-Electrode layer; 213-Piezoelectric layer; 214-Circuit layer; 215-Backing layer; 2151-Positioning hole; 2152-Drive hole one; 2153-Drive hole two;

[0065] 3-Support assembly; 31-Positioning shaft; 32-Positioning sleeve one; 33-Positioning sleeve two;

[0066] 4-Power assembly; 41-Power component one; 42-Power component two; 43-Bourdon tube; 44-Truss one; 45-Truss two;

[0067] 5-Traction wire one; 6-Traction wire two; 561-Traction wire body; 562-Fixing section;

[0068] 701 - Distal imaging plane; 702 - Proximal imaging plane; 703 - Intermediate imaging plane. Detailed Implementation

[0069] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0070] To enable those skilled in the art to better understand the present invention, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the part of the corresponding component that is farther from the operator, typically the end where the component enters the patient's body or surgical area. The proximal end is the part of the corresponding component that is closer to the operator, typically the end held or manipulated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end. Furthermore, it should be noted that the connections mentioned in this application include both direct connections between systems, components, and parts, and indirect connections between systems, components, and parts via a medium. Those skilled in the art should not interpret this as a limitation but should adapt it according to specific needs; all such connections do not exceed the scope of protection of this application.

[0071] The core of this application is to provide a microarray controllable spiral deformation ICE catheter and an imaging range expansion method, which can achieve clear image quality within a dynamic field of view and reduce the need for sheath 1 bending.

[0072] This application provides an ICE catheter with controllable helical deformation of a microarray, including a sheath 1, a support assembly 3, a power assembly 4, a linear array of microtransducers 2, and a traction element; wherein:

[0073] The distal end of the sheath 1 is provided with a hollow acoustic window structure 11, which is used to fill the liquid acoustic coupling medium. The hollow acoustic window structure 11 is connected to a support component 3, a power component 4, a micro transducer linear array 2 and a traction component. The support component 3 is arranged along the axial direction of the sheath 1.

[0074] The micro transducer linear array 2 includes multiple transducer elements 21, each transducer element 21 having a piezoelectric layer 213 perpendicular to the axial direction of the sheath tube 1. The multiple transducer elements 21 are rotatably mounted on the support assembly 3 and arranged sequentially along the axial direction of the sheath tube 1.

[0075] The traction component sequentially connects to multiple transducer array elements 21 and is eccentrically connected to the transducer array elements 21.

[0076] The output end of the power component 4 is connected to the traction member and can drive the traction member to swing. The traction member drives at least some of the transducer array elements 21 of the micro transducer linear array 2 to rotate asynchronously and be arranged in a spiral shape.

[0077] It should be noted that the length direction of the transducer element 21 is parallel to or coincides with the arrangement direction of each transducer element 21 in the micro transducer linear array 2, which is the axial direction of the sheath 1; the thickness direction of the transducer element 21 refers to the stacking arrangement direction of each layer (i.e., matching layer 211, electrode layer 212, piezoelectric layer 213, circuit layer 214 and backing layer 215) in the transducer element 21, which is the radial direction of the sheath 1; the width direction of the transducer element 21 refers to the direction that is perpendicular to both the length direction and the thickness direction of the transducer element 21.

[0078] refer to Figure 2 , Figure 3 , Figure 8 , Figure 9 , Figure 11 , Figure 12As explained, the distal structure of the sheath 1 is a hollow acoustic window structure 11, which is the hollow tube section at the distal end of the sheath 1 that is sound-transmitting (generally referring to the section that can transmit ultrasound waves) to meet the scanning imaging requirements of the micro transducer linear array 2. To ensure better sound transmission, the hollow acoustic window structure 11 is filled with a liquid phase acoustic coupling medium. The inner cavity of the hollow acoustic window structure 11 is also used to accommodate the micro transducer linear array 2, as well as the support component 3, power component 4, and traction component that support and drive its movement.

[0079] The beneficial effect is that each transducer element 21 has a piezoelectric layer 213 perpendicular to the axial direction of the sheath tube 1, which enables scanning. Several transducer elements 21 are arranged sequentially along the axial direction of the hollow acoustic window structure 11 to form a micro transducer linear array 2, which enables sub-aperture scanning at different positions to obtain 2D sub-imaging. Each transducer element 21 in the micro transducer linear array 2 is mounted on a support component 3 arranged along the axial direction of the sheath tube 1 and can rotate around the center line extending along the axial direction of the hollow acoustic window structure 11. Correspondingly, the traction member passes through each transducer element 21 arranged along the axial direction of the hollow acoustic window structure 11 in sequence, and the traction member is connected to the non-rotation center position of each transducer element 21. Correspondingly, the output end of the power component 4 is connected to the end of the traction member, so that several transducer elements 21 are driven to rotate around the axis of the hollow acoustic window structure 11 by the traction member.

[0080] When the traction member drives several transducer array elements 21 to rotate, the traction member is connected to the first end of the power component 4 and is driven to rotate directly. The second end of the traction member is passively rotated under the pulling action generated by the power transmitted by the traction member itself. That is, the second end rotates under the drive of the first end. The rotation of the second end of the traction member has a lag. When the power component 4 drives the transducer array elements 21 to rotate through the traction member, the miniature transducer linear array 2 composed of several transducer array elements 21 presents a spiral array shape. Thus, the ICE catheter of this application can not only adjust the spiral torsion angle in real time according to the needs of the power component 4 to achieve clear image quality in the dynamic field of view, but also reduce the need for sheath 1 bending.

[0081] Based on the above embodiment, the transducer array element 21 includes a matching layer 211, an electrode layer 212, a piezoelectric layer 213, a circuit layer 214 and a backing layer 215 arranged in sequence along the radial direction of the sheath tube 1. The backing layer 215 has a positioning hole 2151 at the middle position along the width direction of the transducer array element 21, and the backing layer 215 also has a transmission hole along the width direction of the transducer array element 21. The transmission hole and the positioning hole 2151 are staggered.

[0082] The support assembly 3 includes a positioning shaft 31, which is connected to the positioning hole 2151 of the transducer array element 21; and a traction member is connected to the transmission hole of the transducer array element 21.

[0083] refer to Figure 16 , Figure 17 , Figure 18 As explained, the transducer array element 21 is formed by stacking a matching layer 211, an electrode layer 212, a piezoelectric layer 213, a circuit layer 214, and a backing layer 215, and the matching layer 211, electrode layer 212, piezoelectric layer 213, circuit layer 214, and backing layer 215 are stacked sequentially along the radial direction of the sheath 1, as shown in the diagram. Figure 18 At the rotation center of the transducer array element 21 (coinciding with the axis of the sheath 1), the matching layer 211, electrode layer 212, piezoelectric layer 213, circuit layer 214 and backing layer 215 are arranged vertically (i.e. radially) from top to bottom, so that, on the basis of satisfying the 2D cross-sectional observation of the internal structure of the heart cavity, the backing layer 215 can cooperate with the support component 3 and the power component 4.

[0084] The backing layer 215 has a positioning hole 2151 at the middle position along the width direction of the transducer element 21, which is used for the positioning shaft 31 of the support assembly 3 to pass through, so as to restrict the position of the transducer element 21 and make it rotate about the axis of the sheath tube 1.

[0085] Furthermore, the backing layer 215 is provided with a transmission hole for the traction member to pass through. The transmission hole is located on the side of the positioning hole 2151 along the width direction of the transducer element 21, so as to be staggered from the positioning hole 2151, so that the traction member is connected to the eccentric position of the transducer element 21.

[0086] It should be noted that the number and distribution of the transmission holes in the transducer array element 21 are not limited, as long as the driving requirements of the transducer array element 21 can be met. Optionally, the number of transmission holes is an even number, such as two, four, or six, and several transmission holes are symmetrically arranged on both sides of the positioning hole 2151 along the width direction of the transducer array element 21. Optionally, the number of transmission holes is an odd number, such as one, three, or five, and several transmission holes are arranged on the same side of the positioning hole 2151 along the width direction of the transducer array element 21. Alternatively, some of the transmission holes are arranged on one side of the positioning hole 2151, and the remaining transmission holes are arranged on the other side of the positioning hole 2151.

[0087] Based on the above embodiments, the power assembly 4 includes a power element 41, which is connected to at least one of the distal and proximal ends of the micro transducer linear array 2 via a traction element, so as to adjust the micro transducer linear array 2 to at least partially be in a spiral array configuration.

[0088] Optionally, the power element 41 is located on either the distal or proximal side of the micro transducer linear array 2. The following explanation uses the example of the power element 41 being located on the distal side of the micro transducer linear array 2 as an example. Please refer to [reference needed]. Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 11 , Figure 12 The right end of the traction component is connected to the output end of the power component 41.

[0089] When using it, please refer to Figure 6 and Figure 13 When the power unit 41 is activated, it drives the traction unit to rotate the transducer array element 21. Then, in the micro transducer linear array 2, the transducer array element 21 from the one closest to the power unit 41 to the one furthest away from the power unit 41 rotates one by one. The transducer array element 21 closest to the power unit 41 rotates first and rotates at the largest angle, while the transducer array element 21 furthest away from the power unit 41 rotates last and rotates at the smallest angle. Finally, the micro transducer linear array 2 is twisted in the forward direction to be arranged in a spiral shape, thereby realizing 3D imaging until the target area (such as the lesion area) appears in the field of view, so as to facilitate subsequent processing (such as cardiac interventional surgery).

[0090] Once the target area appears within the field of view, if 2D imaging is required, or if the resolution remains low due to an excessively large helical angle, such as Figure 1 As shown, the sheath 1 is bent to adjust the direction of the emitting surface of the micro transducer linear array 2, so as to get closer to the tissue area to be observed (such as lesions). Then, the power component 41 is activated to restore the micro transducer linear array 2 to its initial planar state, so that the emitting surface is close to the approximate location of the lesion area, and the 2D imaging function can be activated. However, if the target area cannot be observed from this perspective, the 3D imaging mode is activated again. The power component 41 is controlled to drive the micro transducer linear array 2 to twist and arrange it in a spiral shape to perform the 3D imaging function. During this process, the rotation direction, rotation angle and speed of the power component 41 can be set. Since the emitting surface is now roughly overlapping with the target area, the rotation angle can be set to a small value.

[0091] Optionally, there are two power components 41, located on the far end and near end of the micro transducer linear array 2, respectively. Please refer to [reference needed]. Figure 8 , Figure 9 The right end structure of the traction member (e.g., located on the right truss 44 in the embodiment below) is connected to the output end of the right power member 41 so as to drive the arbitrary rotation of the front end of the micro transducer linear array 2. At the same time, the left end structure of the traction member (e.g., located on the left truss 44 in the embodiment below) is connected to the output end of the left power member 41 so as to drive the arbitrary rotation of the rear end of the micro transducer linear array 2.

[0092] When using it, please refer to Figure 10 Start the front-end power component 41 ( Figure 8 , Figure 9 The power unit 41 located on the left side causes the linear array 2 of micro transducers to rotate in the forward direction to a spiral arrangement, thereby enabling 3D imaging. After the target area (such as the lesion area) appears in the field of view, the movement of the rear power unit 41 is controlled, and the following effects can be achieved:

[0093] In some embodiments, if a better quality image is required, the back-end power component 41 is controlled ( Figure 8 , Figure 9 The rotation direction of the power member 41 located on the right side is the same as that of the front power member 41, so that the micro transducer linear array 2 continues to rotate in the positive direction. After the micro transducer linear array 2 is driven by the front power member 41, the shape of the micro transducer linear array 2 can be adjusted by the rear power member 41 according to the position of the target area in the field of view. This allows the micro transducer linear array 2 to be adjusted to the array spiral angle that completely covers the target area and has relatively good image quality.

[0094] In other embodiments, if it is necessary to further expand the imaging range, two power components 41 are activated simultaneously and controlled to rotate in opposite directions to obtain a larger imaging volume range. For example, if the two power components 41 are set to move by the same angle in opposite rotation directions and additional sub-aperture plane compensation is performed on the increased volume range, a 3D volumetric image close to the image resolution can be obtained at the same frame rate. In this process, by reducing the rotation speed of the two power components 41 and / or increasing the image acquisition frequency, the number of sub-aperture planes can be increased within a fixed larger imaging field of view to achieve high-resolution imaging of a specific target area.

[0095] In other embodiments, if it is necessary to narrow the field of view at this field of view angle, an arbitrary plane is selected within the imaging plane, two power components 41 are activated, and they are controlled to rotate the target angle in opposite directions until the micro transducer linear array 2 returns to its initial planar state. At this point, a clearer 2D image of the cross section can be obtained.

[0096] Alternatively, by controlling the two power components 41 to move in the same direction and at the same speed, the linear array 2 of the micro transducer can be rotated in a planar state, thereby adjusting the imaging angle of the 2D image and obtaining an image of any cross-section inside the heart chamber.

[0097] In summary, on the one hand, controlling the independent movement of the two power components 41 allows for arbitrary adjustment of the emission surface orientation and helical angle of the micro transducer linear array 2 within the hollow acoustic window structure 11; on the other hand, since both power components 41 can independently set their torsion angle and rate, and have the function of pausing and maintaining stillness or performing torsion in the opposite direction at any moment during the torsion process, automatic adjustment of the imaging plane can be achieved, which can significantly improve the surgeon's operating efficiency, reduce intraoperative time, reduce errors caused by manual operation, and find the optimal field of view angle without controlling the emission surface orientation of the micro transducer linear array 2 through the sheath 1.

[0098] Based on the above embodiments, the power assembly 4 also includes a second power component 42, which is connected to the proximal or distal end of the positioning shaft 31 to drive the entire micro transducer linear array 2 to rotate circumferentially.

[0099] Power component 2 42 is located on either the distal or proximal side of the micro transducer linear array 2. The following explanation uses power component 1 41 located on the proximal side of the micro transducer linear array 2 as an example. Please refer to... Figure 11 , Figure 12 The left end of the positioning shaft 31 is connected to the output end of the power component 42 via a coupling. When in use, starting the power component 42 will drive the positioning shaft 31 to rotate the entire micro transducer linear array 2 in a circumferential manner, thus enabling the micro transducer linear array 2 to perform 360-degree scanning imaging in a fixed configuration.

[0100] In some embodiments, the first power component 41 is first controlled to drive some of the transducer array elements 21 of the micro transducer linear array 2 to gradually twist into a spiral array shape. That is, after the micro transducer linear array 2 is controlled to twist to the target or final state, the second power component 42 is then controlled to drive the entire micro transducer linear array 2 to rotate circumferentially. For example, the second power component 42 is controlled to rotate 360 ​​degrees continuously to achieve a full circumferential scanning function of the cardiac cavity structure, or the second power component 42 is controlled to swing bidirectionally at a specified angle to achieve a fan-shaped scanning imaging function for a specific area.

[0101] Furthermore, if the power component 41 is directly or indirectly mounted on the positioning shaft 31 through a connector, then when the power component 42 drives the positioning shaft 31 to rotate, it can drive the entire micro transducer linear array 2 to rotate circumferentially, while simultaneously driving the power component 41 to rotate circumferentially in sync.

[0102] In the embodiment of this application where the ICE conduit is simultaneously provided with power element one 41 and power element two 42, one of power element one 41 and power element two 42 is located on the distal side of the micro transducer linear array 2, and the other is located on the proximal side of the micro transducer linear array 2. It should be noted that, for the purpose of illustrating the principle, Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 7 , Figure 8 , Figure 9 , Figure 11 , Figure 12 , Figure 13 , Figure 14 , Figure 15 As shown, power component 41 is located on the far side of the micro transducer linear array 2, and power component 42 is located on the near side of the micro transducer linear array 2. It is also feasible to interchange the positions of power component 41 and power component 42. Correspondingly, the unit formed by connecting the micro transducer linear array 2, the support component 3 and the traction component is also inverted so that it can be connected to the power component 41 and power component 42 after the position is replaced, so as to realize the corresponding function.

[0103] It should be noted that the types of power components 41 and 42 are not limited, as long as they meet the space requirements and the movement requirements of the linear array 2 of the micro transducers. Preferably, power components 41 and 42 are micro motors.

[0104] In summary, the positioning shaft 31 does not participate in the torsional drive of the power component 41 on the micro transducer linear array 2. It is only used to maintain the position of the transducer array element 21 along the axial direction to maintain the integrity of the micro transducer linear array 2, so that the micro transducer linear array 2 is torn uniformly along the axial direction, and is used to support the power component 4.

[0105] Based on the above embodiments, the power assembly 4 also includes a first truss 44 and a second truss 45 sleeved on the positioning shaft 31;

[0106] Truss 1 44 is located at the far end of the micro transducer linear array 2, and truss 2 45 is located at the near end of the micro transducer linear array 2.

[0107] The two ends of the traction component are fixedly connected to truss 44 and truss 45, respectively;

[0108] The output end of the power component 41 is connected to the truss 44 and / or the truss 45 to rotate relative to the positioning axis 31.

[0109] Please refer to Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 8 , Figure 9 , Figure 11 , Figure 12 , Figure 14Two spaced trusses, namely truss one 44 and truss two 45, are fitted on the positioning shaft 31. A space is left between truss one 44 and truss two 45 to accommodate the micro transducer linear array 2. Bearings are provided between the positioning shaft 31 and the trusses, so that the positioning shaft 31 and the trusses can rotate asynchronously. Since the two ends of the traction member are respectively connected to truss one 44 and truss two 45, the output end of the power member one 41 is connected to one of truss one 44 and truss two 45 through a coupling, so that the center line of the output end of the power member one 41 coincides with the rotation center line of the truss to which it is connected. The other of truss one 44 and truss two 45 is fixed inside the sheath tube 1, which can indirectly drive the traction member to drive at least some of the transducer array elements 21 in the micro transducer linear array 2 to rotate asynchronously and be arranged in a spiral shape.

[0110] It should be noted that there are no restrictions on how the traction component is fixed to the truss, as long as a fixed connection between the two can be achieved. For example, the truss can have an open hole, and after the traction component passes through the truss, a fastener or a fixing component can be fastened on the back side as a blocking structure. The blocking structure should be larger than the diameter of the open hole so that it can be snapped into the truss. Alternatively, the end of the traction component can be snapped into a support base, and then the support base can be installed into the truss.

[0111] Based on the above embodiments, the support component 3 further includes a first positioning sleeve 32 and a second positioning sleeve 33. Both the first positioning sleeve 32 and the second positioning sleeve 33 are sleeved on the outside of the positioning shaft 31. The first positioning sleeve 32 is located on the side of the first truss 44 away from the micro transducer linear array 2 and abuts against the first truss 44. The second positioning sleeve 33 is located on the side of the second truss 45 away from the micro transducer linear array 2 and abuts against the second truss 45.

[0112] The two ends of the positioning shaft 31 pass through truss 44 and truss 45 respectively to position the micro transducer linear array 2. Positioning sleeve 32 and positioning sleeve 33 are respectively fitted at the two free ends of the positioning shaft 31 that extend into the space outside the truss. Positioning sleeve 32 and positioning sleeve 33 are fixedly connected to the positioning shaft 31 and abut against the corresponding truss. This allows the two trusses to clamp and position the micro transducer linear array 2 by directly abutting against it or indirectly abutting it through a buffer structure. Thus, the micro transducer linear array 2 is fixed in a region with a constant axial length. When the micro transducer linear array 2 undergoes torsional deformation, positioning sleeve 32 and positioning sleeve 33 can control the micro transducer linear array 2 to prevent axial tensile deformation, so that the center position of each transducer element 21 remains unchanged at the corresponding position on the axis.

[0113] Detailed explanation is as follows, for reference. Figure 4 and Figure 5As explained, the positioning sleeve 32 on the right abuts against the truss 44, and the diameter of the positioning sleeve 32 is larger than the diameter of the hole through which the right end of the positioning shaft 31 passes in the truss 44, so that the positioning sleeve 32 abuts against the truss 44. At the same time, the positioning sleeve 33 on the left abuts against the truss 45, and the diameter of the positioning sleeve 33 is larger than the diameter of the hole through which the left end of the positioning shaft 31 passes in the truss 45, so that the positioning sleeve 33 abuts against the truss 45.

[0114] Based on the above embodiments, the traction member includes a traction wire body 561 and a plurality of fixed sections 562. The plurality of fixed sections 562 are arranged sequentially along the axial direction of the traction wire body 561, and the plurality of fixed sections 562 are interference-fitted to the transmission holes of the corresponding transducer array element 21 or connected by entanglement.

[0115] Please refer to Figure 19 The main structure of the traction component is a traction wire body 561 extending along the axial direction of the hollow acoustic window structure 11. The two ends of the traction wire body 561 are connected to truss 1 44 and truss 2 45 respectively. In order to achieve cooperation with the transducer array element 21, several fixed sections 562 are machined on the traction wire body 561.

[0116] Optionally, the fixing section 562 is interference-fitted with the transducer array element 21 sleeved on its outer side. In this case, the fixing section 562 can be a rope knot formed by winding the traction wire body 561 or a columnar structure tightly wrapped around the traction wire body 561.

[0117] Optionally, the fixed section 562 can also be connected to the transducer element 21 by entanglement. In this case, the fixed section 562 is a knot formed by winding the traction wire body 561. It can be interference-fitted with the transducer element 21 sleeved on its outside, and can also block the transducer element 21 located between the two by adjacent knots.

[0118] It should be noted that in the embodiment where the traction component includes traction wire 5 and traction wire 6, it should be understood that both traction wire 5 and traction wire 6 include a traction wire body 561 and several fixing sections 562, that is, each unit constituting the traction component includes a traction wire body 561 and several fixing sections 562.

[0119] Based on the above embodiments, the power assembly 4 also includes a spring tube 43, which is movably sleeved on the outside of the positioning shaft 31. The positioning hole 2151 of the transducer array element 21 is connected to the spring tube 43, and the pitch at both ends of the spring tube 43 is greater than the pitch of the middle tube section.

[0120] refer to Figure 14As explained, a spring tube 43 is sleeved on the outside of the positioning shaft 31, and the main shaft and the spring tube 43 can rotate relative to each other around the axis. The spring tube 43 passes through the positioning holes 2151 of each transducer element 21 in sequence along the axis. The process of controlling the torsion of the micro transducer linear array 2 is as follows: each transducer element 21 is deflected around the axis by the traction member. At this time, the positioning shaft 31 ensures that the center of all transducer elements 21 is kept coincident with the axis of the hollow sound window structure 11, while the spring tube 43 applies an additional reverse resistance to the transducer element 21, that is, a force opposite to the deflection direction of the transducer element 21, thereby controlling the deflection angle of the transducer element 21.

[0121] Furthermore, the spring tube 43 uses a non-uniform pitch spring, with the pitch at both ends of the spring tube 43 being greater than the pitch in the middle section. That is, the pitch of the spring tube 43 follows a pattern of being larger at both ends and smaller in the middle. Therefore, during the torsion of the micro-transducer linear array 2, because the torque at both ends of the spring tube 43 is small while the torque in the middle is large, the reverse resistance applied to the micro-transducer linear array 2 also follows a pattern where the reverse resistance experienced by the transducer elements 21 located at both ends along the axial direction is smaller, while the reverse resistance experienced by the transducer elements 21 located in the middle along the axial direction is larger. Consequently, the deflection angle of each transducer element 21 in the middle of the micro-transducer linear array 2 is smaller, while the deflection angle of the front and rear transducer elements 21 is larger, allowing the micro-transducer linear array 2 to exhibit the following behavior: Figure 15 The spiral shape shown is arranged at non-equidistant angles.

[0122] When each transducer element 21 in the linear array 2 of the micro transducer uses the same imaging method, such as Figure 15 As shown, the front-end transducer array 21 can obtain a smaller number of far-end imaging planes 701, the rear-end transducer array 21 can obtain a smaller number of near-end imaging planes 702, and the middle transducer array 21 can obtain a larger number of middle imaging planes 703. The different number of sub-planes along the axis of the micro transducer linear array 2 results in the resolution of the two ends of the image being significantly weaker than that of the middle region.

[0123] The Bourdon tube 43 uses different types of non-equidistant pitch springs, which can realize various irregular array spiral shapes, ensuring a large field of view and selective high-resolution imaging of the target area.

[0124] It should be noted that this embodiment is achieved through... Figure 15 Only one spring structure was shown to achieve this non-equidistant angular spacing arrangement; other non-equidistant grid tubular structures can also achieve similar functional requirements.

[0125] Based on the above embodiments, the distance between the transmission hole and the positioning hole 2151 of each transducer array element 21 is gradually varied, and the distance between the transmission hole and the positioning hole 2151 decreases as the distance between the transducer array element 21 and the power member 41 increases.

[0126] In the embodiment where only one power element 41 is provided, the spacing between the drive hole and the positioning hole 2151 of each transducer element 21 in the micro transducer linear array 2 is different, and the aforementioned spacing (the spacing between the drive hole and the positioning hole 2151 of a transducer element 21 itself) of each transducer element 21 arranged along the axial direction gradually decreases from the side closer to the power element 41 to the side farther away from the power element 41. Taking the example where the power element 41 is located on the far side of the micro transducer linear array 2, please refer to [reference needed]. Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 11 , Figure 12 The rightmost transducer element 21 has the largest distance between its transmission hole and positioning hole 2151, while the leftmost transducer element 21 has the smallest distance between its transmission hole and positioning hole 2151. Furthermore, the aforementioned distances (the distance between the transmission hole and positioning hole 2151 of a transducer element 21 itself) of each transducer element 21 arranged along the axial direction decrease from right to left.

[0127] When each transducer element 21 in the linear array 2 of the micro transducer uses the same imaging method, such as Figure 7 As shown, the front-end transducer array element 21 (which is the far end of each transducer array element 21, such as...) Figure 7 The transducer array element 21 on the right side (i.e., the part of the transducer array element 21 closer to the power component 41) can obtain a far-end imaging plane 701 with a larger angle, while the transducer array element 21 at the rear end can obtain a near-end imaging plane 702 with a smaller angle. Based on this, the transducer array element 21 at the front end of the micro transducer linear array 2 can obtain a smaller number of sub-planes, while the transducer array element 21 at the rear end can obtain a larger number of sub-planes. Within the circumferential imaging angle range, the difference in the number of sub-planes within a certain angle, that is, the difference in the sparseness of the distribution of sub-planes in the front and rear ends, results in the resolution of the near-end region of the image being higher than that of the far-end region.

[0128] For an embodiment that uses two power components 41, please refer to... Figure 8 , Figure 9In the linear array 2 of miniature transducers, the aforementioned spacing (the distance between the transmission hole and the positioning hole 2151 of a transducer element 21) of several transducer elements 21 follows a pattern of being larger at both ends and smaller in the middle. Preferably, the number of transducer elements 21 in the linear array 2 of miniature transducers is even, and each transducer element 21 is divided into two groups along the axial direction. The aforementioned spacing (the distance between the transmission hole and the positioning hole 2151 of a transducer element 21) of the transducer elements 21 in the rear end group of the array decreases gradually from near the proximal end power member 41 to far from the proximal end power member 41, and the aforementioned spacing (the distance between the transmission hole and the positioning hole 2151 of a transducer element 21) of the transducer elements 21 in the front end group of the array decreases gradually from near the distal end power member 41 to far from the distal end power member 41.

[0129] In summary, by controlling the spacing as described above, the eccentricity of the transmission holes of each transducer element 21 is different, resulting in a regular change in the torque caused by the lever arm of each transducer element 21. Thus, the same pulling force generated by the same traction component will cause different torsional responses of each transducer element 21, which helps the micro transducer linear array 2 to be arranged in a spiral array shape.

[0130] Based on the above embodiments, adjacent transducer array elements 21 are spaced apart and each has an movable gap; or,

[0131] There are movable gaps between the matching layers 211, electrode layers 212, piezoelectric layers 213, and circuit layers 214 of adjacent transducer array elements 21, and the backing layers 215 of several transducer array elements 21 are connected into an integral structure, and the backing layer 215 is a layer structure that can be elastically deformed.

[0132] Optional, please refer to Figure 17 In the linear array 2 of micro transducers, each transducer element 21 is independent of each other, and each transducer element 21 is arranged at intervals along the axial direction. That is, there is a gap between any adjacent transducer elements 21. Therefore, the movement between each transducer element 21 is not affected by each other and can deform or displace in any direction.

[0133] Optional, please refer to Figure 16Each transducer element 21 is connected into an integral structure by a reinforcing and protective backing layer 215 to form a complete micro transducer linear array 2. The functional stacked structure of each transducer element 21 (i.e., the structure formed by sequentially laying up the matching layer 211, the electrode layer 212, the piezoelectric layer 213, and the circuit layer 214) is independent of each other. The aforementioned functional stacked structures of each transducer element 21 in the micro transducer linear array 2 are arranged at intervals along the axial direction. That is, there is a movable gap between the aforementioned functional stacked structures of any adjacent transducer element 21. Therefore, when in use, the micro transducer linear array 2 can be deformed by bending the flexible backing layer 215.

[0134] Based on the above embodiment, the traction member includes traction wire 5 and traction wire 6, and the transmission hole includes transmission hole 2152 and transmission hole 2153. Transmission hole 2152 and transmission hole 2153 are symmetrically arranged on both sides of positioning hole 2151. Traction wire 5 passes through transmission hole 2152 of a plurality of transducer array elements 21, and traction wire 6 passes through transmission hole 2153 of a plurality of transducer array elements 21.

[0135] refer to Figure 18 As explained, the backing layer 215 has two transmission holes, namely transmission hole one 2152 and transmission hole two 2153 located on both sides along the width direction of the transducer array element 21. Transmission holes one 2152 and transmission hole two 2153 are symmetrically arranged on both sides of the positioning hole 2151. Correspondingly, the traction component consists of traction wire one 5 and traction wire two 6. Both traction wire one 5 and traction wire two 6 are elastic wire structures. Traction wire one 5 passes sequentially through the transmission holes one 2152 of each transducer array element 21 arranged along the axial direction of the hollow acoustic window structure 11, and traction wire two 6 passes sequentially through the transmission holes two 2153 of each transducer array element 21 arranged along the axial direction of the hollow acoustic window structure 11. Therefore, as... Figure 5 and Figure 14 As shown, traction wire 5 and traction wire 6 are respectively connected to both sides of the rotation center line of the transducer array element 21. Traction wire 5 and traction wire 6 are located on both sides of the positioning shaft 31. Under the drive of the power component 41, the transducer array element 21 achieves eccentric rotation, so that the micro transducer linear array 2 achieves helical torsion.

[0136] Driven by the power assembly 4, the first ends of traction wire 5 and traction wire 6 are directly rotated, while the second ends of traction wire 5 and traction wire 6 are passively rotated under the pulling action generated by the power transmitted by their respective structures. Thus, the power assembly 4 can achieve pure torque drive of the transducer array element 21 through traction wire 5 and traction wire 6, and the forward or reverse rotation of the transducer array element 21 is consistent, which is beneficial to improving the repeatability and stability of the movement.

[0137] In summary, by controlling different component power units, the ICE catheter with controllable spiral deformation of the microarray in this application can have dual functions of array spiral adjustment and array overall adjustment (in the embodiment equipped with power unit 1 41 and power unit 2 42), bidirectional spiral adjustment with dual power units (equipped with two power units 1 41), and unidirectional spiral adjustment (controlling one power unit 1 41), thus adapting to more and more complex clinical application scenarios.

[0138] In addition to the aforementioned microarray controllable helical deformation ICE catheter, an imaging system including the microarray controllable helical deformation ICE catheter disclosed in the above embodiments can also be protected. The imaging system also includes an imaging device, which is signal-connected to the microtransducer linear array 2 and the power component 4. The imaging device is used to control the rotation direction, rotation angle and speed output by the power component 4, and to control the microtransducer linear array 2 to start scanning.

[0139] It should be noted that when the power assembly 4 includes power component 1 41 and / or power component 2 42, the imaging device is used to control the rotation direction, rotation angle and speed of the output end of power component 1 41 and the output end of power component 2 42 respectively.

[0140] In use, the control parameters of the power component 4 are input on the imaging device to control the automatic spiral twisting of the micro transducer linear array 2 by the power component 4, and the scanning of the micro transducer linear array 2 is started by operating the imaging switch.

[0141] In addition to the aforementioned ICE catheter with controllable helical deformation of a microarray, this application also provides a method for expanding the imaging range of the ICE catheter with controllable helical deformation of a microarray disclosed in the above embodiments. The method for expanding the imaging range includes the following steps:

[0142] Step S1: Start the power control component 4, so that some of the transducer array elements 21 of the micro transducer linear array 2 gradually twist into a spiral array shape, and collect dynamic two-dimensional image frames and corresponding spatial pose data.

[0143] Understandably, by controlling the start and movement of the power component 4, the micro transducer linear array 2 is twisted to the target shape, i.e., the spiral array shape. If the micro transducer linear array 2 is in the initial planar state, at this time, the orientation of each transducer element 21 of the micro transducer linear array 2 is the same. Then, in conjunction with the imaging system, it can automatically acquire the 2D imaging plane. After step S1, it is possible to control each transducer element 21 of the micro transducer linear array 2 to acquire two-dimensional image frames (i.e., 2D imaging planes) in different directions. At the same time as acquiring the two-dimensional image frames, it is recorded which transducer element 21 each two-dimensional image frame belongs to, thereby matching different spatial pose data to achieve the corresponding spatial pose data acquisition.

[0144] Regarding the process of controlling the torsion of the linear array 2 of the micro transducers via the power component 4, please refer to the relevant embodiments of the ICE conduit with controllable helical deformation of the micro array described above.

[0145] In some embodiments, since the torsion process of the micro transducer linear array 2 driven by the power component 41 is continuous, optionally, the power component 41 is controlled to perform imaging at a fixed torsion angle, and after the power component 41 torsional by a unit angle, a two-dimensional image frame and the corresponding spatial pose data are acquired. For example, the rotation angle of the power component 41 is set to 15 degrees. In actual imaging, scanning can be performed every 1 degree that the power component 41 rotates, so as to realize the continuous acquisition of two-dimensional image frames and the corresponding spatial pose data, thereby obtaining a 3D image that gradually expands from a 2D image.

[0146] Step S2: Simultaneously process two-dimensional image frames and spatial pose data, and perform data interpolation and fusion in a preset voxel coordinate system using a three-dimensional reconstruction algorithm to generate a continuous three-dimensional volumetric image of the target area.

[0147] This step involves post-processing the set of two-dimensional image frames acquired in step S1. Understandably, on one hand, interpolation is performed on two-dimensional image frames acquired from the same transducer element 21 in different directions to obtain a three-dimensional volume image (i.e., a 3D image) of the ICE conduit axial segment where the transducer element 21 is located. On the other hand, two-dimensional image frames acquired from several transducer elements 21 arranged along the axial direction in the same direction are stitched together to obtain a continuous two-dimensional image of the target area. This step involves comprehensive processing, simultaneously generating the three-dimensional volume images (i.e., 3D images) of the ICE conduit axial segment where each transducer element 21 is located and generating the continuous two-dimensional image of the target area to obtain a continuous three-dimensional volume image of the target area.

[0148] Based on the above embodiments, the micro transducer linear array 2 includes a far-end sub-array, a near-end sub-array, and an intermediate sub-array, and each of the far-end sub-array, the near-end sub-array, and the intermediate sub-array includes a plurality of transducer array elements 21.

[0149] Among them, the image formed by scanning a number of transducer elements 21 in the far-end sub-array is the far-end imaging plane 701, the image formed by scanning a number of transducer elements 21 in the near-end sub-array is the near-end imaging plane 702, and the image formed by scanning a number of transducer elements 21 in the middle sub-array is the middle imaging plane 703.

[0150] Collecting dynamic two-dimensional image frames includes:

[0151] Based on the helical twist angle of the linear array 2 of the micro transducers, the number of excitations of the transducer array elements 21 in the corresponding far-end sub-array, near-end sub-array and middle sub-array is determined.

[0152] The transducer array element 21 in the corresponding far-end subarray, near-end subarray, and middle subarray is excited according to the number of excitations.

[0153] In this embodiment, the number of sub-planes is increased by exciting the tiered transducer array elements 21 to ensure the same image resolution over a larger field of view. Specifically, the micro transducer linear array 2 is divided into three groups at different positions along the axial direction: several transducer array elements 21 in the front end region form the far-end sub-array, several transducer array elements 21 in the rear end region form the near-end sub-array, and several transducer array elements 21 in the middle region form the middle sub-array. Based on this, the two-dimensional image scanned by the far-end sub-array is defined as the far-end imaging plane 701, the two-dimensional image scanned by the near-end sub-array is defined as the near-end imaging plane 702, and the two-dimensional image scanned by the middle sub-array is defined as the middle imaging plane 703.

[0154] Correspondingly, after driving the micro transducer linear array 2 to spirally twist to arrange it in a spiral shape, the deformation of the micro transducer linear array 2 can be determined based on the spiral twist angle of the micro transducer linear array 2. This correspondence can be obtained through experiments. Then, according to the spiral twist angle of the micro transducer linear array 2, the number of excitations of transducer array elements 21 in the corresponding far-end sub-array, near-end sub-array and middle sub-array is adjusted in real time to ensure the resolution of the image in different regions along the axial direction.

[0155] It is feasible to increase the number of excitations in the far-end subarray when increasing the helical torsion angle of the micro transducer linear array 2. For example, when increasing the helical torsion angle of the micro transducer linear array 2 to expand the detection range, such as from a helical deflection angle of 23 degrees to a helical deflection angle of 28 degrees, more transducer elements 21 in the head-end subarray are excited based on the transducer elements 21 excited when the micro transducer linear array 2 is at a helical deflection angle of 23 degrees, so as to perform scanning imaging, and the resulting image is stitched together with the image formed when the micro transducer linear array 2 is at a helical deflection angle of 23 degrees to ensure a high image resolution.

[0156] It should be noted that when only one power component 41 is provided, the above-mentioned spiral torsion angle refers to the rotation angle of the power component 41. When two power components 41 are provided, the above-mentioned spiral torsion angle includes the rotation angles of both power components 41.

[0157] Meanwhile, to ensure the scanning range, the method for determining the number of excitations for the far-end sub-array, near-end sub-array, and intermediate sub-array is as follows:

[0158] Excite the corresponding number of transducer elements 21 in the far-end subarray, near-end subarray, or intermediate subarray so that the scanning range of the corresponding subarray is greater than or equal to the helical twist angle.

[0159] Understandably, the minimum requirement is that the subarray with the largest deformation in the linear array 2 of the micro transducers excites more transducer elements 21 so that the scanning range of the subarray with the largest deformation is greater than or equal to the helical twist angle, so as to basically meet the exploration requirements.

[0160] Of course, it is not limited to the subarray with the largest deformation in the above-mentioned micro transducer linear array 2 exciting more transducer elements 21. For example, it can also refer to the subarray with the smallest deformation in the far-end subarray, near-end subarray and middle subarray exciting more transducer elements 21, so that the scanning range of the subarray with the smallest deformation is greater than or equal to the helical twist angle, so as to basically meet the exploration requirements.

[0161] Preferably, since the distal array often detects tissues deeper within the body, in order to reduce the length of the ICE catheter inserted into the body, it can be set to excite a corresponding number of transducer elements 21 in the distal array so that the scanning range of the distal array is greater than or equal to the helical twist angle.

[0162] It should be noted that the relational terms such as "*** one" and "*** two" described above are only used to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities; the "upper surface, lower surface, top, bottom" and the orientation words "up, down, left, right" described above are all defined based on the accompanying drawings of the specification.

[0163] The various embodiments in this specification are described in a progressive manner. Each embodiment focuses on the differences from other embodiments. For the same or similar parts among the embodiments, reference can be made to each other.

[0164] The above has introduced in detail the microarray controllable helical deformation ICE catheter and the imaging range expansion method provided by the present application. Specific examples are used herein to elaborate on the principle and implementation manner of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present application, several improvements and modifications can be made to the present application, and these improvements and modifications also fall within the protection scope of the present application.

Claims

1. An ICE catheter with microarray controllable helical deformation, characterized in that, include: The sheath has a hollow acoustic window structure at its distal end. The hollow acoustic window structure is used to fill a liquid acoustic coupling medium. A support component, a power component, a linear array of micro transducers, and a traction component are connected inside the hollow acoustic window structure. The support component is arranged along the axial direction of the sheath. The micro transducer linear array includes multiple transducer elements, each of which has a piezoelectric layer perpendicular to the axis of the sheath. The multiple transducer elements are rotatably mounted on the support assembly and arranged sequentially along the axis of the sheath. The traction component sequentially connects to multiple transducer array elements and is eccentrically connected to the transducer array elements. The output end of the power component is connected to the traction member and can drive the traction member to swing. The traction member drives at least a portion of the transducer array elements of the micro transducer linear array to rotate asynchronously and arrange them in a spiral shape. The transducer array element includes a matching layer, an electrode layer, a piezoelectric layer, a circuit layer, and a backing layer arranged in sequence along the radial direction of the sheath. The backing layer has a positioning hole at the middle position along the width direction of the transducer array element, and the backing layer also has a transmission hole along the width direction of the transducer array element. The transmission hole is offset from the positioning hole. The support assembly includes a positioning shaft connected to the positioning hole of the transducer array element; the traction member is connected to the transmission hole of the transducer array element.

2. The ICE catheter with controllable helical deformation of a microarray according to claim 1, characterized in that, The power assembly includes a power element one, which is connected to at least one of the distal and proximal ends of the micro-transducer linear array via the traction element, to adjust the micro-transducer linear array to at least partially form a helical array configuration; and / or, The power assembly also includes a second power component, which is connected to the proximal or distal end of the positioning shaft to drive the entire linear array of micro transducers to rotate circumferentially.

3. The ICE catheter with controllable helical deformation of a microarray according to claim 2, characterized in that, The power assembly also includes truss one and truss two, which are sleeved on the positioning shaft; The first truss is located at the far end of the linear array of micro transducers, and the second truss is located at the near end of the linear array of micro transducers. The two ends of the traction component are respectively fixedly connected to the first truss and the second truss; The output end of the power component one is connected to the truss one and / or the truss two to rotate relative to the positioning axis.

4. The ICE catheter with controllable helical deformation of a microarray according to claim 3, characterized in that, The support assembly further includes a positioning sleeve one and a positioning sleeve two. Both the positioning sleeve one and the positioning sleeve two are sleeved on the outside of the positioning shaft. The positioning sleeve one is located on the side of the truss one away from the micro transducer linear array and abuts against the truss one. The positioning sleeve two is located on the side of the truss two away from the micro transducer linear array and abuts against the truss two. And / or, the traction member includes a traction wire body and a plurality of fixed sections, the plurality of fixed sections being arranged sequentially along the axial direction of the traction wire body, and the plurality of fixed sections being interference-fitted into or connected by entanglement to the transmission hole corresponding to the transducer array element.

5. The ICE catheter with controllable helical deformation of a microarray according to claim 1, characterized in that, The power assembly also includes a spring tube, which is movably sleeved on the outside of the positioning shaft. The positioning holes of the transducer array element are connected to the spring tube, and the pitch at both ends of the spring tube is greater than the pitch of the middle tube section.

6. The ICE catheter with controllable helical deformation of a microarray according to claim 2, characterized in that, The distance between the transmission hole and the positioning hole of each transducer element is gradually varied, and the distance between the transmission hole and the positioning hole decreases as the distance between the transducer element and the power component increases.

7. The ICE catheter with controllable helical deformation of a microarray according to claim 1, characterized in that, The adjacent transducer elements are spaced apart and each has a movable gap; or, There are movable gaps between the matching layers, electrode layers, piezoelectric layers and circuit layers of adjacent transducer array elements, and the backing layers of several transducer array elements are connected into an integral structure, and the backing layer is a layer structure that can elastically deform.

8. The ICE catheter with microarray controllable helical deformation according to any one of claims 1-7, characterized in that, The traction component includes traction wire one and traction wire two, and the transmission hole includes transmission hole one and transmission hole two. The transmission hole one and transmission hole two are symmetrically arranged on both sides of the positioning hole. The traction wire one passes through the transmission hole one of the plurality of transducer array elements, and the traction wire two passes through the transmission hole two of the plurality of transducer array elements.

9. A method for extending the imaging range, characterized in that, The method, applied to the ICE catheter with microarray controllable helical deformation according to any one of claims 1-8, comprises: The power component is activated, causing some of the transducer elements of the linear array of micro transducers to gradually twist into a spiral array shape, and dynamic two-dimensional image frames and corresponding spatial pose data are collected. The two-dimensional image frame and the spatial pose data are processed synchronously, and the data are interpolated and fused in a preset voxel coordinate system through a three-dimensional reconstruction algorithm to generate a continuous three-dimensional volumetric image of the target area.

10. The method according to claim 9, characterized in that, The micro transducer linear array includes a far-end sub-array, a near-end sub-array, and an intermediate sub-array, and each of the far-end sub-array, the near-end sub-array, and the intermediate sub-array includes a plurality of the transducer array elements; The image formed by scanning a plurality of transducer elements in the far-end sub-array is the far-end imaging plane, the image formed by scanning a plurality of transducer elements in the near-end sub-array is the near-end imaging plane, and the image formed by scanning a plurality of transducer elements in the middle sub-array is the middle imaging plane. The collection of dynamic two-dimensional image frames includes: Based on the helical twist angle of the linear array of the micro transducers, the number of excitations for the transducer elements in the far-end sub-array, the near-end sub-array, and the middle sub-array is determined. The transducer array elements in the far-end sub-array, the near-end sub-array, and the intermediate sub-array are excited according to the number of excitations; The method for determining the number of excitations corresponding to the far-end subarray, the near-end subarray, and the intermediate subarray is as follows: Excite a corresponding number of transducer elements in the far-end subarray, the near-end subarray, or the intermediate subarray such that the scanning range of the corresponding subarray is greater than or equal to the helical twist angle.

Images