A dual-view microprobe for catheter-based ultrasound imaging applications

Abstract

The application provides a double-view microprobe based on a catheter ultrasonic imaging application, which comprises a catheter, a front-view structure and a side-view structure arranged in the catheter, the front-view structure is located at one end of the catheter, and the side-view structure is close to the front-view structure and is distributed along the circumference of the catheter; an FPC electrically connected with the front-view structure and the side-view structure, the front-view structure comprises front-view piezoelectric elements arranged on the FPC, and a first matching layer arranged on the side of the front-view piezoelectric elements close to the end of the catheter and coupled with the front-view piezoelectric elements; the side-view structure comprises side-view piezoelectric elements and a second matching layer arranged in the catheter along the radial direction from inside to outside, the side-view piezoelectric elements are electrically connected with the FPC, and the second matching layer is coupled with the side-view piezoelectric elements; the front-view structure and the side-view structure are integrated together, can provide views in two directions at the same time when imaging in a heart cavity, and solve the limitation problem that a single view has a blind spot when displaying lesions in intracavity blood vessel navigation and cardiac ablation treatment in some cases such as chronic total occlusion (CTO).

Description

Technical Field

[0001] This invention relates to the field of ultrasound imaging technology, and in particular to a dual-view microprobe for catheter-based ultrasound imaging applications. Background Technology

[0002] Cardiovascular disease is one of the most prevalent diseases among the elderly in China. Taking atrial fibrillation (AF) as an example, there are over 20 million AF patients in China, with an incidence rate as high as 10% among those over 75 years old. With the accelerating aging process, the number of AF patients in China will grow rapidly. This large cardiovascular patient population urgently needs more accessible, precise, and safe surgical treatment.

[0003] China has been introducing minimally invasive interventional cardiac treatment for over 30 years. In traditional interventional procedures, X-rays are essential for visualization, but they pose radiation hazards to both doctors and patients. Furthermore, X-ray imaging has limited detail and poor sensitivity in monitoring complications, thus limiting the surgeon's ability to operate the procedure.

[0004] Non-invasive imaging technology-guided interventional procedures have gradually become the standard practice in modern interventional cardiac surgery. ICE (Interventional Electrophysiology) can directly visualize the heart structure, accurately reflecting the anatomical relationships between different parts of the heart. It improves image quality and reduces or avoids fluoroscopy and angiography, making the surgery safer, more precise, and more efficient. It is increasingly being used to guide various cardiac interventional procedures and monitor intraoperative complications, serving as an important auxiliary tool during the procedure. Frost & Sullivan data shows that the total number of electrophysiological surgeries in China currently exceeds 200,000 cases annually and continues to grow rapidly at a double-digit rate. The market size of structural cardiac interventional devices in my country has grown from 400 million yuan in 2017 to 2 billion yuan in 2021, and is projected to reach 10.4 billion yuan by 2025. It is foreseeable that the ICE market will also experience rapid growth in tandem. Currently, common 2D-ICE catheters are divided into two categories: single-element rotating ultrasound catheters and electronic phased array ultrasound catheters. However, both only provide a view in one direction at a time. In some special application scenarios, such as endovascular navigation of chronic total occlusion (CTO) and lesion visualization in cardiac ablation therapy, the single view has the limitation of blind spots. Summary of the Invention

[0005] The purpose of this invention is to solve the technical problem that common 2D-ICE in the prior art are divided into two categories: single-element rotating ultrasound catheters and electronic phased array ultrasound catheters. However, both only provide a view in one direction at a time. In some special application scenarios, such as endovascular navigation of chronic total occlusion (CTO) and lesion display in cardiac ablation therapy, the single view has blind spots.

[0006] To address the aforementioned technical problems, this invention provides a dual-view micro probe for catheter-based ultrasound imaging applications, comprising: a catheter, a front-view structure and a side-view structure disposed within the catheter, the front-view structure being located at one end of the catheter, the side-view structures being close to the front-view structure and distributed circumferentially along the catheter, and an FPC electrically connected to the front-view structure and the side-view structure; the front-view structure including a front-view piezoelectric array element disposed on the FPC, and a first matching layer disposed on the side of the front-view piezoelectric array element near the end of the catheter and coupled to the front-view piezoelectric array element; the side-view structure including a side-view piezoelectric array element and a second matching layer sequentially disposed radially from the inside to the outside along the catheter, the side-view piezoelectric array element being electrically connected to the FPC, and the second matching layer being coupled to the side-view piezoelectric array element.

[0007] Furthermore, it also includes a first backing corresponding to the front-view structure and a second backing corresponding to the side-view structure. The FPC has a first portion connected to the front-view piezoelectric element and a second portion connected to the side-view piezoelectric element. The first backing is disposed on the side of the first portion away from the front-view piezoelectric element, and the second backing is disposed on the side of the second portion away from the side-view piezoelectric element.

[0008] Furthermore, the first matching layer is an alumina matching layer covering the outside of the forward-looking piezoelectric array element.

[0009] Furthermore, the second matching layer is an alumina matching layer covering the outside of the side-viewed piezoelectric array element.

[0010] Furthermore, it also includes a pure epoxy matching layer, which covers the outside of the alumina matching layer.

[0011] Furthermore, it also includes an EPO-TEK301 matching layer, which covers the outside of the alumina matching layer.

[0012] Furthermore, the FPC includes a first FPC and a second FPC that are independent of each other, with the front view structure connected to the first FPC and the side view structure connected to the second FPC.

[0013] Furthermore, the second backing is a cylindrical structure composed of two semi-cylinders, and the second FPC is disposed on the outer peripheral sidewall of the cylindrical structure; the number of side-view structures is two or more, disposed on the side of the FPC away from the second backing and evenly distributed along the circumference of the cylindrical structure.

[0014] Furthermore, the first FPC is a strip structure, including a clamping part located between two semi-cylinders and an extension section extending from the side of the clamping part to the end of the second backing and protruding beyond the end of the second backing. The extension section is continuously bent to form a parallel part parallel to the axial section of the conduit. The front view structure is pasted on the side of the parallel part near the outside of the conduit, and the first backing is fixed on the side of the parallel part opposite to the front view structure.

[0015] Furthermore, the extension section is bent to form a receiving space for accommodating the first backing, and the shape and size of the receiving space match the shape and size of the first backing.

[0016] As can be seen from the above technical solution, the beneficial effects of the present invention are: integrating the front-view structure and the side-view structure into a catheter with a limited space, so that it can provide views in two directions at the same time when imaging in the heart chamber, solving the limitation problem of blind spots in a single view when displaying lesions in certain specific situations such as intravascular navigation and cardiac ablation therapy for chronic total occlusion (CTO). Attached Figure Description

[0017] Figure 1 This is a three-dimensional structural schematic diagram of the dual-view microcatheter provided in this application.

[0018] Figure 2 This is an exploded view of the front view structure provided in this application.

[0019] Figure 3 This is an exploded view of the side view structure provided in this application.

[0020] The reference numerals in the attached figures are explained as follows: 1. Front view structure; 2. Side view structure; 3. Front view piezoelectric element; 4. Alumina matching layer; 5. Pure epoxy matching layer; 6. First FPC; 7. Side view piezoelectric element; 8. Alumina matching layer; 9. EPO-TEK301 matching layer; 10. Second FPC; 11. First backing; 12. Second backing. Detailed Implementation

[0021] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.

[0022] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0023] To further illustrate the principles and structure of the present invention, preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0024] Please see Figure 1-3 The present embodiment provides a dual-view micro probe for ultrasound imaging based on a catheter, including a catheter, a front view structure 1 for front view imaging disposed at the front end of the catheter, and a side view structure 2 for side view imaging distributed along the circumference of the catheter, both of which are disposed inside the catheter.

[0025] Specifically, the aforementioned front and side view structures are encapsulated in a stainless steel tube and integrated into a single conduit.

[0026] This application also includes an FPC (flexible printed circuit board), with both the front-view structure 1 and the side-view structure 2 disposed on the FPC. The front-view structure 1 includes a front-view piezoelectric array 3 and a first matching layer. The front-view piezoelectric array 3 is located at the front end of the conduit, disposed on the FPC and electrically connected to the FPC. The first matching layer is coupled to the front-view piezoelectric array 3. The side-view structure 2, distributed along the circumference of the conduit, includes a side-view piezoelectric array 7 and a second matching layer. The side-view piezoelectric array 7 and the second matching layer are arranged sequentially from the inside to the outside along the radial direction of the conduit. The side-view piezoelectric array 7 is disposed on the FPC and electrically connected to the FPC. The second matching layer is coupled to the side-view piezoelectric array 7. The first matching layer and the second matching layer are used to optimize the propagation performance of ultrasound waves to improve the imaging quality of the front-view structure and the side-view structure 2.

[0027] Furthermore, the front view structure 1 and the side view structure 2 of the microcatheter of the present invention are electrically connected to an external controller via an FPC. The number of FPCs can be one or more. Preferably, in order to facilitate the fabrication of the catheter, the number of FPCs of the present invention corresponds to the number of the front view structure 1 and the side view structure 2. The FPC has a first part connected to the front view structure 1 and a second part connected to the side view structure 2.

[0028] Furthermore, the present invention also includes a first backing 11 corresponding to the front-view structure 1 and a second backing 12 corresponding to the side-view structure 2. Both the first backing 11 and the second backing 12 are tungsten-containing backings. The first backing 11 is disposed on the side of the first part away from the front-view piezoelectric array element 3, and the second backing 12 is disposed on the side of the second part away from the side-view piezoelectric array element 7.

[0029] It should be noted that the number of FPCs mentioned above can be multiple. As shown in the figure, the first part is the first FPC6, the second part is the second FPC10, the first FPC6 and the second FPC10 are independent of each other, the front view structure 1 is connected to the first FPC6 in a one-to-one correspondence, and the side view structure 2 is connected to the second FPC10 in a one-to-one correspondence. The microcatheter of the present invention adopts the design of multiple FPCs, and the scheme to be described below will be based on multiple FPCs.

[0030] like Figure 3 As shown, the second backing 12 corresponding to the side view structure 2 described above is a cylindrical structure composed of two semi-cylinders. The cylindrical structure is coaxially arranged with the microcatheter. The second FPC 10 corresponding to the side view structure 2 is arranged on the outer peripheral sidewall of the cylindrical structure. There are two or more side view structures 2, which are arranged on the side of the FPC away from the second backing 12 and are evenly distributed along the circumference of the cylindrical structure.

[0031] Furthermore, the aforementioned front view structure 1 and the first backing 11 are located on one side of the end of the second backing 12 described above. The first FPC6 is a strip structure, including a clamping part located between two semi-cylinders and an extension section extending from the side of the clamping part toward the end of the second backing 12 and protruding beyond the end of the second backing 12, as shown in the figure. The extension section has a parallel part that is parallel to the axial section of the conduit. The parallel part is formed by continuously bending the extension section. The front view structure 1 is pasted on the side of the parallel part near the outside of the conduit. The first backing 11 is fixed on the side wall of the parallel part opposite to the front view structure 1.

[0032] Furthermore, after continuous bending of the extension section, a receiving space is formed to accommodate the first backing 11. The first backing 11 is fixedly pasted in the receiving space. The shape and size of the receiving space match the shape and size of the first backing 11. The design of this receiving space can shorten the distance between the front view structure 1 and the second backing 12, reduce structural gaps, make the structure more compact, and thus enhance the structural strength of one end of the conduit.

[0033] The second backing 12 is designed as a cylindrical structure composed of two semi-cylinders, and the first FPC6 extends from between the two semi-cylinders to one end of the catheter. This design integrates the front-viewing structure 1 and the side-viewing structure 2 into a catheter with a limited space, enabling it to provide views in two directions simultaneously during intracardiac imaging. This solves the limitation of blind spots in a single view when endovascular navigation and lesion visualization in certain situations such as chronic total occlusion (CTO) and cardiac ablation therapy.

[0034] As an example of the first matching layer, the first matching layer coupled with the forward piezoelectric array element 3 described above is an alumina matching layer 4 covering the outside of the forward piezoelectric array element 3. The alumina matching layer 4 has the characteristics of high sound velocity and low attenuation, which can improve the propagation speed and energy of ultrasonic waves.

[0035] In a further embodiment, the first matching layer also includes a pure epoxy matching layer 5, which covers the outside of the alumina matching layer. The pure epoxy matching layer 5 has the characteristics of high acoustic impedance and low attenuation, which can better transmit ultrasonic energy to the target tissue.

[0036] As an embodiment of the second matching layer, the second matching layer coupled to the side-view piezoelectric array element 7 described above is an alumina matching layer 8 covering the outside of the side-view piezoelectric array element 7. The function of the alumina matching layer 8 is described in the embodiment of the first matching layer.

[0037] In a further embodiment, the second matching layer also includes an EPO-TEK301 matching layer 9, which covers the outside of the alumina matching layer. The EPO-TEK301 matching layer 9 is used to further optimize the propagation performance of ultrasound waves, reduce the reflection and scattering of sound waves, and make the image clearer.

[0038] The following is a detailed description of the technical solution of this invention.

[0039] As shown in the figure, this is a dual-view microcatheter based on a catheter, including a front-view structure 1 and a side-view structure 2.

[0040] The front-view structure 1 includes a front-view piezoelectric element 3, an alumina matching layer 4, a pure epoxy matching layer 5, a dedicated first FPC 6, and a first backing 11; the side-view structure 2 includes a side-view piezoelectric element 7, an alumina matching layer 8, an EPO-TEK301 matching layer 9, a dedicated second FPC 10, and a second backing 12. After the front-view piezoelectric element 3 is cut, one side is gold-plated and coupled with the alumina matching layer 4 and the pure epoxy matching layer 5. The other side is gold-plated and electrodes are marked. The dedicated first FPC 6 is then bonded to form an electrical connection, and the first backing 11 is bonded to the back of the first FPC 6 to eliminate acoustic reflection interference. After gold plating on one side of the piezoelectric array element 7, an aluminum oxide matching layer 8 is bonded. After cutting, an EPO-TEK301 matching layer 9 is coupled. Gold plating on the back of the piezoelectric array element 7 and bonding a dedicated second FPC10 are performed. A second backing 12 is bonded to the back of the second FPC10 to eliminate acoustic reflection interference. The acoustic stack is completely cut from the top to the bottom surface to create an array with mechanical and electrical isolation. The element cutting depth must be carefully controlled to completely isolate individual positive electrodes while keeping the second FPC10 substrate undamaged.

[0041] Although the invention has been described with reference to several typical embodiments, it should be understood that the terminology used is illustrative and exemplary, and not restrictive. Since the invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims. Therefore, all variations and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. A dual-view miniature probe for catheter-based ultrasound imaging applications, characterized in that, The device includes a catheter, a front-view structure and a side-view structure disposed within the catheter, the front-view structure being located at one end of the catheter, and the side-view structures being close to the front-view structure and distributed circumferentially along the catheter; an FPC electrically connected to the front-view structure and the side-view structure; the front-view structure includes a front-view piezoelectric element disposed on the FPC, and a first matching layer disposed on the side of the front-view piezoelectric element near the end of the catheter and coupled to the front-view piezoelectric element; the side-view structure includes a side-view piezoelectric element and a second matching layer disposed sequentially from the inside to the outside along the radial direction of the catheter; the side-view piezoelectric element is electrically connected to the FPC, and the second matching layer is coupled to the side-view piezoelectric element; It also includes a first backing corresponding to the front view structure and a second backing corresponding to the side view structure; The FPC includes a first FPC and a second FPC that are independent of each other. The front view structure is connected to the first FPC, and the side view structure is connected to the second FPC. The second backing is a cylindrical structure composed of two semi-cylinders, and the second FPC is disposed on the outer peripheral sidewall of the cylindrical structure; The first FPC is a strip structure, including a clamping part located between two semi-cylinders, and an extension section extending from the side of the clamping part to the end of the second backing and protruding beyond the end of the second backing; the extension section is continuously bent to form a parallel part parallel to the axial section of the catheter, and the front view structure is attached to the side of the parallel part near the outside of the catheter. The extension is bent to form a receiving space for accommodating the first backing, and the shape and size of the receiving space match the shape and size of the first backing; the first backing is fixed in the receiving space and pasted to the side of the parallel portion away from the front view structure.

2. The dual-view miniature probe for catheter-based ultrasound imaging applications according to claim 1, characterized in that, The FPC has a first portion connected to a forward-looking piezoelectric element and a second portion connected to a side-looking piezoelectric element. A first backing is disposed on the side of the first portion away from the forward-looking piezoelectric element, and a second backing is disposed on the side of the second portion away from the side-looking piezoelectric element.

3. The dual-view miniature probe for catheter-based ultrasound imaging applications according to claim 1 or 2, characterized in that, The first matching layer is an alumina matching layer covering the outside of the forward-looking piezoelectric array element.

4. The dual-view microprobe for catheter-based ultrasound imaging applications according to claim 1 or 2, characterized in that, The second matching layer is an alumina matching layer covering the outside of the side-viewed piezoelectric array element.

5. The dual-view miniature probe for catheter-based ultrasound imaging applications according to claim 3, characterized in that, It also includes a pure epoxy matching layer, which covers the outside of the alumina matching layer.

6. The dual-view miniature probe for catheter-based ultrasound imaging applications according to claim 4, characterized in that, It also includes an EPO-TEK301 matching layer, which covers the outside of the alumina matching layer.

7. The dual-view miniature probe for catheter-based ultrasound imaging applications according to claim 2, characterized in that, There are two or more side-view structures, which are located on the side of the FPC away from the second backing and are evenly distributed along the circumference of the cylindrical structure.

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