CN113081045A - Intravascular forward-looking detection device - Google Patents

Abstract

The invention provides an intravascular forward-looking detection device, comprising an intravascular forward-looking probe, the intravascular forward-looking probe comprising a casing, a CMUT ultrasonic sensor array, a collection control chip and a flexible shaft with a cable, and the outer casing is hollow Cylindrical structure, the CMUT ultrasonic sensor array and the acquisition control chip are embedded in the casing, and are integrally fixedly connected with the cable flexible shaft, and move back and forth together with the cable flexible shaft; the intravascular forward-looking detection device can be Forward imaging is performed at the distal end of the catheter tip to determine the direction of the vascular lumen and the shape and structure of the lesion, improve the success rate of CTO lesions, reduce the occurrence of intraoperative vascular perforation, dissection, etc., shorten the operation time, and reduce the amount of X-ray radiation. It can significantly reduce the amount of intraoperative contrast agent and reduce the occurrence of contrast agent nephropathy.

Description

An intravascular forward-looking detection device

technical field

The invention relates to the technical field of medical devices, in particular to an intravascular forward-looking detection device.

Background technique

Chronic total occlusion (CTO) lesions have a low surgical success rate, with an early surgical success rate of only 48-76%. Among the reasons for surgical failure, the failure of the guide wire to pass through the occlusive lesions accounted for the vast majority (63-92%). Before the blunt head occlusion, if there is no thicker branch and cannot be helped by the IVUS equipment currently used in clinical practice, in order to improve the success rate of the operation, doctors use a new type of guidance with a harder head, better support and better maneuverability. Steel wire and tapered tip guide wire, but it is difficult to judge whether the distal end of the guide wire is located in the true lumen by the resistance encountered by the guide wire and the flexibility of the tip movement. Perforated or ruptured veins are the most common cause of CTO complications. Specifically: the current intraoperative application of IVUS to guide CTO interventional therapy has certain limitations. Because the distal end of the IVUS catheter is located about 10.5 to 23 mm distal to the imaging element, which requires a relatively long vascular space, the current IVUS probe in clinical applications can only look sideways but not forward, and only the probe can be extended to the side of the occlusion site (branch). Blood vessels) can only be imaged by withdrawing or advancing the catheter to find the entrance of the occluded lesion. When encountering CTO lesions with ambiguous stumps, because it is formed after acute rupture of coronary plaque, platelets first aggregate at the plaque rupture and block the blood vessel, then the thrombus gradually extends to the proximal segment of the diseased blood vessel, and finally ends at the branch At the opening of the blood vessel bifurcation, resulting in the formation of a CTO lesion with an indistinct stump. Such lesions are only treated by bilateral angiography with ambiguous stump CTO-PCI. Angiographic images may not accurately locate the entrance stump of the CTO lesion, the puncture guidewire lacks a focus, and studies have found that about 96% of chronic total occlusions Calcifications are present in the lesions, of which about 68% are only a small amount of calcium, while the proportion of calcifications found on angiography is about 61%. Most occlusive lesions have a proximal fibrous cap, but only about 50% have a distal fibrous cap. During the interventional treatment of CTO, the guide wire can easily enter the relatively soft subintima and media, and intramural hematoma occurs in about 34%. At the same time, if the calcification is too severe, the probability of the guide wire entering the subintima will be relatively increased. . Therefore, the guide wire easily slips into the branch vessel or into the false lumen, making this type of operation more difficult. In order to improve the success rate of surgery, doctors use new guide wires with a harder tip, better support and maneuverability, and a tapered tip guide wire, but it is difficult to pass the resistance encountered by the guide wire and the tip end. Whether the distal end of the guide wire is located in the true lumen is judged by the flexibility of the movement. If the judgment is wrong, coronary perforation or rupture caused by the guide wire is a common cause of the most serious complications of CTO. If head-end imaging ultrasound is used, the position of the true vascular lumen can be guided in real time, and the advancing direction of the guide wire can be guided along the true vascular lumen to reduce intraoperative complications. In order to accurately locate the stump of the stump ambiguous CTO, physicians use intravascular ultrasound to help the surgeon perform this type of surgery. However, if the diameter of the collateral vessels around the occluded vessel is smaller than the diameter of the IVUS catheter, this method is not applicable, and it is also unsuccessful if the vessels without collateral vessels around the occluded lesion are occluded. Second, the current IVUS catheter cannot provide information on the vessels distal to the occlusion, and bilateral coronary angiography is still needed to observe the collateral vessels at the distal end of the occlusion. In addition, in CTO complicated with calcification lesions, such lesions can block the judgment of intravascular ultrasound on the occluded stump, and interfere with the identification and judgment of the true lumen of blood vessels.

At the same time, coronary perforation is the most common and serious complication in PCI of CTO lesions, with an incidence rate ranging from 0.29% to 0.93%. Coronary artery rupture caused by guide wire in PCI is the most common case. One case is seen in the case where the rigid guide wire enters the false lumen and causes the coronary artery rupture. Delayed cardiac tamponade with serious consequences. At present, the special guide wires for CTO lesions (Conquest/Conquest pro series, Cross it series, etc.) have a very strong ability to pass through the lesions. Such as misjudgment, misuse of balloon to pass or expand, often lead to severe coronary rupture.

SUMMARY OF THE INVENTION

The technical problem to be solved by the present invention is to provide an intravascular forward-looking probe.

For solving the above-mentioned technical problems, the technical scheme of the present invention is:

An intravascular forward-looking detection device, comprising an intravascular forward-looking probe (20-60MHz), the intravascular forward-looking probe comprising a housing (1a), a CMUT ultrasonic sensor array (2) (ie, a capacitive ultrasonic microarray sensor based on ), an acquisition control chip (3) and a flexible shaft (1b) with a cable, the outer casing (1a) is a hollow cylindrical structure, and the CMUT ultrasonic sensor array (2) and the acquisition control chip (3) are embedded in the casing ( 1a), and the whole is fixedly connected with the flexible shaft with cable (1b), and moves back and forth together with the flexible shaft with cable (1b).

Preferably, in the above-mentioned intravascular forward-looking detection device, the CMUT ultrasonic sensor array (2) includes a plurality of vibration element ultrasonic units with independent circuits, the vibration element ultrasonic unit is composed of a plurality of thin film vibration elements (2b), and the thin film vibrates The element (2b) uses a CMUT thin film structure, including an upper electrode (21), a vibrating membrane (22), a cavity (23) and a substrate (24) connected in sequence, and is connected through the electrode (21) and the acquisition control chip ( 3) Connect.

Preferably, in the above-mentioned intravascular forward-looking detection device, the shape of the thin film vibration element (2b) may be circular or square, and may be the same or different.

Preferably, in the above-mentioned intravascular forward-looking detection device, the package size of the CMUT ultrasonic sensor array is 0.5-2 mm.

Preferably, in the above-mentioned intravascular forward-looking detection device, the acquisition control chip (3) includes a pulse signal generator, a transceiver/transmit control switch with a multiplexer, a high-speed analog front end (for amplifying, filtering, analog-digital conversion) and a control chip, the pulse signal generator, the receiving/transmitting control switch, the high-speed analog front-end and the control chip are connected in turn by cyclic circuits, and the receiving/transmitting control switch is connected with the CMUT ultrasonic sensor array (2) circuit.

Preferably, the above-mentioned intravascular forward-looking detection device further comprises an interventional catheter (4), the intravascular forward-looking probe is placed in the interventional catheter, and the flexible shaft (1b) with a cable is connected to a motor circuit, and the intravascular front-view probe is placed in the interventional catheter. The sight probe drives a flexible shaft (1b) with a cable through a motor, and uses the movement of the flexible shaft (1b) with a cable to realize the sliding detection and automatic retraction of the intravascular forward-looking probe in the intervention catheter.

Preferably, in the above-mentioned intravascular forward-looking detection device, the outer diameter of the interventional catheter (4) is 0.5-3 mm.

Preferably, in the above-mentioned intravascular forward-looking detection device, the interventional catheter (4) is an IVUS catheter.

Preferably, the above-mentioned intravascular forward-looking detection device further includes a host computer (that is, a computer with corresponding digital signals and image processing), and the host computer is connected to the control chip of the acquisition control chip (3) and the motor through a cable. The machine and the control chip carry out information exchange transmission and real-time control of the motor.

Preferably, in the above-mentioned intravascular forward-looking detection device, the material of the outer casing (1a) is copper or other metal materials.

Beneficial effects:

In the above-mentioned intravascular forward-looking detection device, the intravascular forward-looking probe includes a group of forward-looking CMUT ultrasonic sensor arrays, which can realize forward-looking ultrasonic imaging with high resolution and large scanning angle. Its clinical significance lies in the ability to perform forward imaging at the distal end of the catheter tip, so that the catheter does not need to enter the side branch first to advance or retract the catheter, it can observe the exact position of the guide wire in the coronary artery in real time, and can guide the false lumen. The guide wire re-enters the true lumen, and in some occluded lesions, it can provide clear CTO entry information, visualize the proximal lesions of the occluded vessels, and provide a real-time road map of the occluded vessels during PCI. Through the information provided by the intravascular forward-looking probe, we can fully understand the running direction and position of the guide wire in the blood vessel, determine the running direction of the vascular lumen, and provide sufficient information for the intraoperative operation of the guide wire.

Whether it is an anterior or reverse approach to open CTO lesions, the guide wire technology is the core. Although the guide wire enters the subintima or "false lumen" and then enters the true lumen of the blood vessel from the "false lumen" (including ADR and reverse CART) to open the occluded blood vessel, after the guide wire passes through the subintimal or "false lumen" , if the guide wire is punctured from the subintima to the media or the adventitia, it may be complicated by coronary perforation or even cardiac tamponade. Therefore, the application uses the unique imaging advantages of the endovascular forward-looking probe to track the guide wire at any time. It can guide the operation of the guide wire in the true lumen of the lumen or return from the false lumen to the true lumen at any time, so as to improve the success rate of CTO lesions and reduce the intraoperative The occurrence of vascular perforation, dissection, etc., shortens the operation time, reduces the amount of X-ray radiation, and can also significantly reduce the amount of intraoperative contrast agent, thereby reducing the occurrence of contrast agent nephropathy.

Description of drawings

1 is a schematic structural diagram of an intravascular forward-looking detection device according to the present invention;

2 is a circuit control diagram of the intravascular forward-looking detection device according to the present invention;

3 is a schematic structural diagram of the CMUT ultrasonic sensor array of the intravascular forward-looking detection device according to the present invention, including a partial enlarged view of an ultrasonic unit of a vibrating element and a schematic diagram of a single thin-film vibrating element (small black circle part);

FIG. 4 is a schematic diagram showing the combined appearance of three types of catheter CMUT arrays and packaging shells of the CMUT ultrasonic sensor array of the intravascular forward-looking detection device according to the present invention.

In the figure, 1- Intravascular forward-looking probe 1a-Housing 1b-Flexible shaft with cable

2-CMUT ultrasonic sensor array 3-Acquisition control chip 4-Interventional catheter

2a-vibration element ultrasonic unit 2b-film vibration element 21-upper electrode

22-diaphragm 23-cavity 24-electrode substrate

Detailed ways

Example 1

As shown in Figures 1-4, the intravascular forward-looking detection device includes an intravascular forward-looking probe 1 (20-60MHz), and the intravascular forward-looking probe 1 includes a housing 1a, a CMUT ultrasonic sensor array 2 (ie, based on Capacitive ultrasonic microarray sensor), acquisition control chip 3 and flexible shaft 1b with cable, the outer casing 1a is a hollow cylindrical structure of copper metal material, the CMUT ultrasonic sensor array 2 and the acquisition control chip 3 are embedded in the casing 1a inside, and the whole is fixedly connected with the flexible shaft 1b with cable, and moves back and forth together with the flexible shaft 1b with cable; wherein,

The package size of the CMUT ultrasonic sensor array 2 is 0.5-2mm, and includes a number of vibration element ultrasonic units 2a with independent circuits. The vibration element ultrasonic unit 2a is composed of several thin-film vibration elements 2b. The thin-film vibration element 2b uses a CMUT film. The structure includes an upper electrode 21, a diaphragm 22, a cavity 23 and a substrate with electrodes 24 connected in sequence, and is connected to the acquisition control chip 3 through the electrode 21. The shape of the thin film vibration element 2b can be a circle or a square, can be the same or different;

The acquisition control chip 3 includes a pulse signal generator, a receiving/transmitting control switch with a multiplexer, a high-speed analog front end (for amplifying, filtering, and analog-to-digital conversion) and a control chip. The pulse signal generator, The receiving/transmitting control switch, the high-speed analog front end and the control chip are connected in turn by cyclic lines, and the receiving/transmitting control switch is connected with the CMUT ultrasonic sensor array 2 lines;

The above-mentioned intravascular forward-looking detection device also includes an interventional catheter 4 with an outer diameter of 0.5-3 mm, the interventional catheter 4 is an IVUS catheter, and the intravascular forward-looking probe is placed in the interventional catheter, and the flexible shaft 1b with a cable is placed in the interventional catheter. Connected with the motor circuit, the intravascular forward-looking probe drives the flexible shaft 1b with cable through the motor, and uses the movement of the flexible shaft 1b with the cable to realize the sliding detection and automatic retraction of the intravascular forward-looking probe in the interventional catheter;

The above-mentioned intravascular forward-looking detection device also includes a host computer (that is, a computer with corresponding digital signals and image processing), and the host computer is connected by a cable to the control chip of the acquisition control chip 3 (the model is US7846101B2, and other same function chips can also be used. Substitute) and the motor, the upper computer and the control chip carry out information exchange transmission and real-time control of the motor.

When working, the intravascular forward-looking probe is electronically scanned by the acquisition control chip, and can move back and forth together with the interventional catheter. Use the host computer to control the acquisition control chip for signal transmission and reception and signal/image processing, and at the same time control the automatic retraction device through the host computer to realize the forward and backward movement of the intravascular forward-looking probe.

Specifically, the pulse signal generator of the acquisition control chip is controlled by the host computer to generate an excitation pulse signal (analog excitation signal), and the front-end CMUT sensor array is triggered by the receiving/transmitting control switch with a multiplexer to form a forward-looking Ultrasonic scanning sound field in the direction of direction; receiving ultrasonic echo signals, through the control chip receiving/transmitting control switch and high-speed analog front-end (amplification, filtering, analog-to-digital conversion), reaching the host computer for mathematical signal processing to obtain the scan in the front view field Direction of imaging data; repeatedly changing the array element delay to change the direction of the scanning sound beam, until the data acquisition and transmission of the entire front view is completed, image reconstruction and subsequent processing are performed on the host computer to obtain two-dimensional and local three-dimensional images; With the obtained image information, the clinician judges the blockage and stenosis of the front-end blood vessels, and determines whether the catheter advances or retreats; through the retraction or advancement of the catheter, the entire transducer position is moved backward or forward for a certain distance, and all the aforementioned imaging is repeated. The process is performed until the acquisition of images corresponding to different positions of a blood vessel is completed, and these images are integrated into three-dimensional images of all detection areas.

The above are only the preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications can be made. It should be regarded as the protection scope of the present invention.

Claims (10)

1. An intravascular forward-looking detection device, comprising: including the probe of looking forward in the blood vessel, the probe of looking forward in the blood vessel includes shell (1a), CMUT ultrasonic sensor array (2), acquisition control chip (3) and flexible axle (1b) of electrified cable, outer casing (1a) is the hollow cylindrical structure, CMUT ultrasonic sensor array (2) and acquisition control chip (3) inlay in shell (1a) to whole with flexible axle (1b) fixed connection of electrified cable to along with flexible axle (1b) of electrified cable back-and-forth movement together.

2. The endovascular forward-looking probe device of claim 1, wherein: the CMUT ultrasonic sensor array (2) comprises a plurality of vibrating element ultrasonic units of independent circuits, each vibrating element ultrasonic unit is composed of a plurality of thin film vibrating elements (2b), each thin film vibrating element (2b) adopts a CMUT thin film structure, and the CMUT ultrasonic sensor array comprises an upper electrode (21), a vibrating diaphragm (22), a cavity (23) and an electrode substrate (24) which are sequentially connected and is connected with an acquisition control chip (3) through the electrode (21).

3. The endovascular forward-looking probe device of claim 2, wherein: the shape of the thin film vibration element (2b) is circular or square.

4. The endovascular forward-looking detection device of claim 1 or 2, wherein: the packaging size of the CMUT ultrasonic sensor array is 0.5-2 mm.

5. The endovascular forward-looking probe device of claim 1, wherein: the acquisition control chip (3) comprises a pulse signal generator, a receiving/transmitting control switch with a multiplexer, a high-speed simulation front end and a control chip, wherein the pulse signal generator, the receiving/transmitting control switch, the high-speed simulation front end and the control chip are sequentially connected in a circulating circuit, and the receiving/transmitting control switch is connected with the CMUT ultrasonic sensor array (2) in a circuit mode.

6. The endovascular forward-looking probe device of claim 1, wherein: still include and intervene pipe (4), the intraductal forward looking probe of blood is arranged in this and is intervene in the pipe, take cable flexible shaft (1b) and motor circuit connection, the intraductal forward looking probe passes through the motor and drives and takes cable flexible shaft (1 b).

7. The endovascular forward-looking probe device of claim 6, wherein: the outer diameter of the interventional catheter (4) is 0.5-3 mm.

8. The endovascular forward-looking detection device of claim 6 or 7, wherein: the interventional catheter (4) is an IVUS catheter.

9. The endovascular forward-looking probe device of claim 1, wherein: the motor control system is characterized by further comprising an upper computer, wherein the upper computer is connected with a control chip and a motor of the acquisition control chip (3) through a cable, and the upper computer and the control chip carry out information interaction transmission and carry out real-time control on the motor.

10. The endovascular forward-looking probe device of claim 1, wherein: the material of the outer casing (1a) is a copper metal material.

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