Ring array transducer and forward-looking intracardiac ultrasound sheath

Abstract

This invention discloses a ring array transducer and a forward-facing intracardiac ultrasound sheath. The ring array transducer includes an energy-absorbing cylinder; a flexible circuit layer disposed on a first annular mounting surface, with each flexible circuit extending axially along the energy-absorbing cylinder and having an extension section at one end that bends and extends to a second annular mounting surface; an active element layer disposed on the second annular mounting surface, including a plurality of radially arranged active elements, each active element correspondingly connected to an extension section of a flexible circuit; and an acoustic matching layer bonded to the second annular mounting surface covering the active element layer. This invention, through ring imaging using the ring array transducer, enables more convenient intracardiac intervention via blood vessels, significantly reducing X-ray exposure. The ultrasound imaging catheter and interventional channel are integrated into one, expanding the application scenarios of current ICE (Endocardial Intravascular Electrosurgical) procedures and greatly reducing X-ray dependence, even achieving zero X-ray exposure.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of intracardiac ultrasound imaging technology, in particular to an annular array transducer and a forward-looking intracardiac ultrasound sheath. BACKGROUND

[0002] Cardiac and peripheral vascular intervention surgery has replaced surgical operation as the most widely used clinical procedure due to its minimally invasive and safety. Common clinical scenarios include vascular stent implantation, cardiac pacemaker implantation, arrhythmia catheter ablation, structural heart disease intervention, etc. The above surgical operations all need to be guided by X-ray in real time to direct the surgical instruments (including guide wire, puncture needle, balloon, occluder pacemaker electrode, ablation catheter, etc.) to be sent into, attached to, penetrated or fixed to specific cardiovascular anatomical sites. Therefore, the current dependence of such surgeries on X-ray is still relatively large, and the learning curve is long, which is not conducive to widespread development.

[0003] Intracardiac ultrasound (ICE) catheter imaging is an emerging interventional imaging technology. It is a flexible catheter with a miniature ultrasound transducer probe inserted directly into the blood vessels and heart chambers through the vascular route. It can emit and receive high-frequency ultrasound signals to provide real-time high-resolution anatomical information, including identification of cardiac structures and real-time tracking of catheter position in the heart. It can also effectively identify surgical complications such as cardiac tamponade and thrombosis. In addition, it has the advantages of simple operation, no need for additional personnel assistance, no radiation, and no need for general anesthesia. Therefore, ICE has replaced the traditional digital subtraction angiography (DSA) and has become the most ideal imaging tool for cardiac intervention surgery.

[0004] However, there are still obvious limitations in using ICE imaging to guide cardiac intervention surgery in clinical practice, which limits its application value. The main manifestations are as follows: the currently used ICE is side-viewing and two-dimensional, and the ICE catheter is separate from the interventional channel and instruments. When guiding the interventional surgery, the ICE sector needs to be adjusted patiently to track the interventional instruments to obtain their long-axis ultrasound images. The surgeon and the assistant need to be skilled in cooperation, which is time-consuming and labor-intensive, has a long learning period, and has limited application. SUMMARY

[0005] The technical problem to be solved by the present application is to provide a forward-looking intracardiac ultrasound sheath to solve the problem of ICE being side-viewing and two-dimensional, the ICE catheter being separate from the interventional channel and instruments, the need for patient adjustment of the ICE sector to track the interventional instruments to obtain their long-axis ultrasound images, the need for skilled cooperation between the surgeon and the assistant, the time-consuming and labor-intensive nature, the long learning period, and the limited application.

[0006] To solve the above technical problems, one technical solution adopted by the present application is to provide an annular array transducer, comprising:

[0007] An energy absorbing cylinder, comprising a first annular mounting surface on the inner hole wall and a second annular mounting surface on one end;

[0008] A flexible circuit layer arranged on the first annular mounting surface, the flexible circuit layer comprising a plurality of uniformly spaced flexible circuits, each flexible circuit extending along the axial direction of the energy absorbing cylinder and having an extension section arranged on one end of the flexible circuit and extending to the second annular mounting surface;

[0009] An active element layer arranged on the second annular mounting surface, the active element layer comprising a plurality of active elements arranged in a radial pattern, each active element being connected to the extension section of one of the flexible circuits, and one active element and one extension section forming a connection unit;

[0010] An acoustic matching layer bonded to the second annular mounting surface to cover the active element layer.

[0011] In one or more embodiments, the second annular mounting surface is provided with a plurality of accommodation grooves corresponding to the plurality of connection units.

[0012] Another technical solution adopted by the present application is to provide a preparation method of an annular array transducer, comprising:

[0013] bonding the active element layer and the flexible circuit layer to form a first element;

[0014] cutting the first element into a plurality of uniformly arranged micro-arrays, each micro-array comprising one active element and one flexible circuit;

[0015] bending each micro-array so that the micro-array is divided into a first section and a second section, wherein the first section comprises part of the flexible circuit, and the second section comprises another part of the flexible circuit and the active element;

[0016] arranging the first sections of the plurality of micro-arrays in a ring shape, and arranging the second sections to extend outward;

[0017] fixing an energy absorbing cylinder around the plurality of micro-arrays, wherein the inner wall of the energy absorbing cylinder is bonded to at least part of the first sections, and one end surface of the energy absorbing cylinder is bonded to the second sections;

[0018] bonding an acoustic matching layer to the end surface of the energy absorbing cylinder to cover the active elements.

[0019] In one or more embodiments, the step of cutting the first element into a plurality of uniformly arranged micro-arrays, each micro-array comprising one active element and one flexible circuit, specifically comprises:

[0020] bonding the first element to a UV debonding film;

[0021] cutting the first element into a plurality of micro-arrays arranged uniformly, each micro-array comprising an active element and a flexible circuit;

[0022] UV photolysis of the UV debonding film, and taking out the plurality of micro-arrays.

[0023] Yet another technical solution adopted by the present application is to provide a forward cardiac intracavity ultrasound sheath, comprising a sheath, the sheath comprising a distal end and a proximal end arranged oppositely, the distal end being provided with the annular array transducer of any of the above-mentioned embodiments

[0024] In one or more embodiments, the sheath comprises an inner tube and an outer tube, the annular array transducer is located between the inner tube and the outer tube and is sleeved outside the inner tube, the second annular mounting surface is located on the side facing the distal end, and the annular array transducer is connected to the proximal end for signal transmission through the lead wire passing through the gap between the inner tube and the outer tube.

[0025] In one or more embodiments, the distal end face of the sheath is provided with an acoustic lens.

[0026] In one or more embodiments, the inner part of the outer tube is hollow, a guide channel extending from the proximal end to the side of the distal end is formed, and a guide wire is inserted in the guide channel, and the end of the guide wire close to the distal end is fixed with the outer tube to realize the bending angle control of the distal end.

[0027] In one or more embodiments, the proximal end of the sheath is connected with a handle, a rotating mechanism connected with the guide wire is sleeved on the handle, and the rotating mechanism is used to control the movement of the guide wire.

[0028] In one or more embodiments, a central channel extending along the axial direction of the sheath is formed in the sheath, and a sealing device for sealing the central channel is arranged at the proximal end of the sheath.

[0029] Compared with the prior art, the present application has the following beneficial effects:

[0030] The annular array transducer of the present application can realize annular imaging, has simple structure, is convenient to operate, has lower requirement on the learning period of the operator, and has wide application range;

[0031] The preparation method of the annular array transducer of the present application is simple to operate, low in cost, and can ensure the manufacturing precision;

[0032] The forward cardiac intracavity ultrasound sheath of the present application can be more conveniently inserted into the heart cavity from the blood vessel through the annular imaging of the annular array transducer, and greatly reduces the X-ray exposure;

[0033] The forward heart intracavity ultrasound sheath of the present application combines the ultrasound imaging catheter and the intervention channel, adjusts the sheath to image the target area, and then sends the intervention instrument along the sheath to directly reach the position, which is convenient, safe and simple to operate, expands the application scene of the current ICE, greatly reduces the X-ray dependence of such surgery, and even can achieve zero X-ray;

[0034] The forward heart intracavity ultrasound sheath of the present application can realize the adjustment of the bending angle of the distal end, so as to facilitate the adjustment of the intervention direction of the sheath in the body and the intervention. BRIEF DESCRIPTION OF DRAWINGS

[0035] Figure 1 is a structural schematic diagram of an embodiment of the forward heart intracavity ultrasound sheath of the present application;

[0036] Figure 2 is a structural schematic diagram of an embodiment of the ring array transducer of the present application;

[0037] Figure 3 is a partial structural schematic diagram of an embodiment of the ring array transducer of the present application.

[0038] In the drawings:

[0039] Sheath 100; distal end 101; proximal end 102; inner tube 103; outer tube 104; acoustic lens 105; guide channel 106; guide wire 107;

[0040] Ring array transducer 200; energy absorption cylinder 201; first ring mounting surface 2011; second ring mounting surface 2012; accommodating groove 2013; flexible circuit layer 204; flexible circuit 2041; extension section 2042; active element layer 205; active element 2051; acoustic matching layer 206;

[0041] Handle 300; rotating mechanism 301. DETAILED DESCRIPTION

[0042] The present application will be described in detail below in combination with the drawings and embodiments.

[0043] Please refer to Figure 1 , Figure 1 is a structural schematic diagram of an embodiment of the forward heart intracavity ultrasound sheath of the present application.

[0044] The forward heart intracavity ultrasound sheath includes a sheath 100, and the sheath 100 includes oppositely arranged distal end 101 and proximal end 102, wherein the distal end 101 is provided with a ring array transducer 200.

[0045] The sheath 100 comprises an inner tube 103 and an outer tube 104, and the annular array transducer 200 is located between the inner tube 103 and the outer tube 104 and is sleeved on the inner tube 103, and the annular array transducer 200 is connected to the proximal end 102 for signal transmission through the lead wire passing through the gap between the inner tube 103 and the outer tube 104.

[0046] Specifically, please refer to Figure 2 and Figure 3 , Figure 2 is a structural schematic diagram of an embodiment of the annular array transducer of the present application, Figure 3 is a partial structural schematic diagram of an embodiment of the annular array transducer of the present application.

[0047] The annular array transducer 200 comprises an energy absorption cylinder 201.

[0048] The energy absorption cylinder 201 comprises a first annular mounting surface 2011 located on the inner hole wall and a second annular mounting surface 2012 located at one end.

[0049] The first annular mounting surface 2011 is provided with a flexible circuit layer 2041, and the flexible circuit layer 204 comprises a plurality of flexible circuits 2041 arranged at uniform intervals, each flexible circuit 2041 is arranged in the axial direction of the energy absorption cylinder 201, and one end of the flexible circuit 2041 is provided with an extension segment 2042 extending to the second annular mounting surface 2012.

[0050] The second annular mounting surface 2012 is provided with an active element layer 205, and the active element layer 205 comprises a plurality of active elements 2051 arranged in a radial manner, each active element 2051 is connected with the extension segment 2042 of one flexible circuit 2041, and one active element 2051 and one extension segment 2042 cooperate to form a connection unit.

[0051] The second annular mounting surface 2012 is bonded with an acoustic matching layer 206 covering the active element layer 205.

[0052] It can be understood that the plurality of active elements 2051 arranged in a radial manner on the second annular mounting surface 2012, and each active element 2051 realizes signal transmission through one flexible circuit 2041, which can realize annular imaging and is more convenient for sending the sheath 100 into the heart cavity under the guidance of ultrasound.

[0053] When the annular array transducer 200 is applied to the forward heart cavity ultrasound sheath 100, the flexible circuit layer 204 is adhered to the outer wall of the inner tube 103, the energy absorption cylinder 201 is sleeved on the outer wall of the inner tube 103 to cover at least part of the flexible circuit layer 204, and the extension segment 2042 of the flexible circuit 2041 is arranged to extend outward and be fixedly attached to the surface near the distal end 101 of the energy absorption cylinder 201.

[0054] In order to further ensure the uniform arrangement of the active element 2051 and the flexible circuit 2041, a plurality of accommodation grooves 2013 corresponding to the plurality of connection units are formed on the second annular mounting surface 2012 of the energy absorption cylinder 201.

[0055] As shown in Figure 1 In order to further improve the imaging effect of the annular array transducer 200, the acoustic lens 105 is further arranged on the end face of the distal end 101 of the sheath 100.

[0056] In order to further facilitate the intervention of the sheath 100 in the body, the outer tube 104 is hollow inside and forms a guide channel 106 extending from the proximal end 102 to the side of the distal end 101. The guide wire 107 is inserted into the guide channel 106, and the end of the guide wire 107 close to the distal end 101 is fixed to the outer tube 104 to control the bending angle of the distal end 101.

[0057] The guide wire 107 can be a high-strength steel wire or other materials. By pulling the guide wire 107, the anchor point fixed with the guide wire 107 can be moved, thereby bending the distal end 101 of the sheath 100 to adjust the direction, so as to facilitate the intervention of the sheath 100 in the body.

[0058] In order to realize the precise control of the guide wire 107, the proximal end 102 of the sheath 100 is connected with a handle 300 in the embodiment, and the handle 300 is provided with a rotating mechanism 301 connected with the guide wire 107. The rotating mechanism 301 can slide along the handle 300 by rotating, thereby driving the guide wire 107 to move. In one application scenario, the rotating mechanism 301 can be threadedly connected with the handle 300 to realize the conversion between the rotating motion and the linear motion, thereby improving the accuracy of the movement of the guide wire 107.

[0059] In order to realize the setting of the intervention channel while realizing the ultrasonic imaging, the sheath 100 is provided with an intervention channel extending along the axial direction of the sheath 100 in the embodiment. When the sheath 100 is intervened in place by the ultrasonic imaging of the annular array transducer 200, the intervention instrument can be directly positioned through the intervention channel, which is convenient, safe and simple to operate, and expands the application scenario of the current ICE, greatly reduces the X-ray dependence of such surgery, and even can achieve zero X-ray.

[0060] In order to avoid the blood flowing out of the intervention channel, the proximal end 102 of the intervention channel is further provided with a sealing device.

[0061] The preparation method comprises:

[0062] S100 bonding the active element layer and the flexible circuit layer to form a first element.

[0063] S200 cuts the first element into a plurality of micro-arrays arranged uniformly, each micro-array comprising an active element and a flexible circuit.

[0064] Specifically, in one embodiment, S200 specifically comprises:

[0065] bonding the first element on a UV debonding film;

[0066] cutting the first element into a plurality of micro-arrays arranged uniformly, each micro-array comprising an active element and a flexible circuit;

[0067] UV light irradiation debonding of the UV debonding film, and taking out the plurality of micro-arrays.

[0068] It can be understood that by bonding and fixing the first element first, and then debonding after cutting, the cutting precision can be effectively guaranteed, and the operation is facilitated.

[0069] S300 bends each micro-array, so that the micro-array is divided into a first segment and a second segment, wherein the first segment comprises part of the flexible circuit, and the second segment comprises another part of the flexible circuit and the active element.

[0070] S400 arranges the first segments of the plurality of micro-arrays in a ring shape uniformly, and the second segments extend outward.

[0071] S500 fixes a energy absorption cylinder around the plurality of micro-arrays, wherein the inner wall of the energy absorption cylinder is bonded to at least part of the first segment, and one end surface of the energy absorption cylinder is bonded to the second segment.

[0072] S600 bonds an acoustic matching layer on the end surface of the energy absorption cylinder, covering the active element.

[0073] The above is only an embodiment of the present application, and does not limit the patent scope of the present application, and any equivalent structure or equivalent process transformation using the content of the specification and drawings, or direct or indirect application in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A ring array transducer, characterized by, The application relates to a ring array transducer and a preparation method thereof. The ring array transducer comprises an energy absorption cylinder, a flexible circuit layer and an active element layer. The energy absorption cylinder comprises a first annular mounting surface on the inner hole wall and a second annular mounting surface on one end. The flexible circuit layer is arranged on the first annular mounting surface and comprises a plurality of uniformly spaced flexible circuits. Each flexible circuit extends along the axial direction of the energy absorption cylinder and is provided with an extension section on one end, which is bent to extend to the second annular mounting surface. The active element layer is arranged on the second annular mounting surface and comprises a plurality of active elements arranged in a radial manner. Each active element is connected with the extension section of one flexible circuit, and one active element and one extension section form a connection unit. An acoustic matching layer is bonded on the second annular mounting surface to cover the active element layer. The preparation method of the ring array transducer comprises the following steps. Bonding the active element layer and the flexible circuit layer to form a first element. Cutting the first element into a plurality of micro-arrays which are uniformly arranged. Each micro-array comprises one active element and one flexible circuit.

2. The annular array transducer of claim 1, wherein, Each micro-array is bent to divide the micro-array into a first section and a second section. The first section comprises part of the flexible circuit, and the second section comprises another part of the flexible circuit and the active element. The second annular mounting surface is provided with a plurality of accommodation grooves corresponding to the connection units. The first sections of the plurality of micro-arrays are arranged in a ring shape, and the second sections extend outward.

3. An antegrade intracardiac ultrasonic sheath, comprising: The energy absorption cylinder is sleeved and fixed outside the plurality of micro-arrays.

4. The forward heart endo-luminal ultrasound sheath of claim 3, wherein, The inner wall of the energy absorption cylinder is bonded with at least part of the first sections, and one end surface of the energy absorption cylinder is bonded with the second sections.

5. The echogenic forward cardiac endovascular sheath according to claim 4, wherein, An acoustic matching layer is bonded on the end surface of the energy absorption cylinder to cover the active element.

6. The forward-acting cardiac endoluminal ultrasound sheath of claim 4, wherein, The step of cutting the first element into a plurality of micro-arrays which are uniformly arranged and each comprising one active element and one flexible circuit comprises the following steps.

7. The forward-acting cardiac endoluminal ultrasound sheath of claim 6, wherein, Bonding the first element on a UV debonding film. Cutting the first element into a plurality of micro-arrays which are uniformly arranged and each comprising one active element and one flexible circuit. UV light is used to debond the UV debonding film, and the plurality of micro-arrays are taken out. The sheath comprises a distal end and a proximal end arranged oppositely. The ring array transducer is arranged on the inner tube and the outer tube. The second annular mounting surface is arranged on the side facing the distal end. The ring array transducer is connected to the proximal end through a lead wire passing through the gap between the inner tube and the outer tube to realize signal transmission. The distal end of the sheath is provided with an acoustic lens. The inner part of the outer tube is hollow and provided with a guide channel extending from the proximal end to the side of the distal end. A guide wire is arranged in the guide channel. The end of the guide wire close to the distal end is fixed to the outer tube to control the bending angle of the distal end. The proximal end of the sheath is connected with a handle. A rotating mechanism connected with the guide wire is arranged on the handle to control the movement of the guide wire.

8. The forward-acting cardiac endoluminal ultrasound sheath of claim 3, wherein, The sheath is provided with an interventional channel extending along the axial direction of the sheath.

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