CN215128980U - Intravascular forward-looking detection device - Google Patents
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- CN215128980U CN215128980U CN202120809070.7U CN202120809070U CN215128980U CN 215128980 U CN215128980 U CN 215128980U CN 202120809070 U CN202120809070 U CN 202120809070U CN 215128980 U CN215128980 U CN 215128980U
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Abstract
The utility model provides an intravascular forward-looking detection device, which comprises an intravascular forward-looking probe, wherein the intravascular forward-looking probe comprises a shell, a CMUT (capacitive micromachined ultrasonic transducer) array, an acquisition control chip and a flexible shaft with a cable, the outer casing is of a hollow cylindrical structure, the CMUT ultrasonic transducer array and the acquisition control chip are embedded in the shell, are integrally and fixedly connected with the flexible shaft with the cable and move back and forth along with the flexible shaft with the cable; the intravascular forward-looking detection device can perform forward imaging at the far end of the catheter head end, determine the deformation direction of a blood vessel cavity and the pathological change morphological structure, improve the success rate of CTO pathological change surgery, reduce the occurrence of blood vessel perforation, interlayer and the like in the surgery, shorten the surgery duration, reduce the X-ray radiation amount, also can obviously reduce the use amount of contrast agent in the surgery and reduce the occurrence of contrast agent nephropathy.
Description
Technical Field
The utility model belongs to the technical field of the medical instrument technique and specifically relates to an endovascular foresight detection device.
Background
The success rate of the operation of Chronic Total Occlusion (CTO) lesion is low, and the success rate of the operation is only 48 to 76 percent in the early stage. The failure of the guide wire to pass through the occluded lesion accounts for the majority of the failure reasons (63-92%). Before blunt-end occlusion lesion, if thick branches do not exist, when the IVUS equipment used in clinic at present cannot be applied to provide help, in order to improve the success rate of surgery, a doctor uses a novel guide steel wire with a harder head end and better supporting force and controllability and a tapered head end guide steel wire, but whether the far end of the guide wire is positioned in a true cavity or not is difficult to judge through the resistance met by the guide wire and the flexibility degree of head end movement, and if the judgment is wrong, coronary perforation or rupture caused by the guide wire is the most common reason for CTO complications. Specifically, the method comprises the following steps: the current intraoperative IVUS-guided CTO interventional therapy has certain limitations. Because the distal end of the IVUS catheter is located approximately 10.5 to 23mm distal of the imaging element, requiring a relatively long vascular space, current IVUS probes in clinical use are only side-looking and not forward-looking, and the site of the occlusion lesion entry can be imaged and sought only by extending the probe to the side of the occlusion (branch vessel) and then passing the catheter back or forward. When encountering a stub-fuzzy CTO lesion, because it is formed after acute rupture of coronary plaque, platelets firstly gather at the plaque rupture and block the blood vessel, and then the thrombus gradually extends to the proximal section of the diseased blood vessel and finally ends at the bifurcation opening of the branch blood vessel, thereby forming the stub-fuzzy CTO lesion. These lesions are treated by stump-obscured CTO-PCI surgery only by bilateral imaging, the imaging images may not accurately locate the CTO lesion entry stump, the penetrating guidewire lacks the focus of force, and studies have found calcification in about 96% of chronic total occlusion lesions, of which about 68% is only a small amount of calcium, while imaging has found calcification in a proportion of about 61%. Most occlusive lesions present a proximal fibrous cap, but only about 50% present a fibrous cap at the distal end. During CTO interventions the guide wire easily enters the softer sub-intima and media locations, with some 34% of the cases of intramural hematomas and a relatively increased probability of the guide wire entering the sub-intima if the calcification is too severe. The guidewire is therefore easily slid into the branch vessel or into the false lumen, making such procedures more difficult. In order to improve the success rate of the operation, a doctor uses a novel guide steel wire with a harder head end and better supporting force and controllability and a tapered head end guide steel wire, but whether the far end of the guide wire is positioned in a true cavity or not is difficult to judge through the resistance met by the guide wire and the flexibility degree of the movement of the head end, and if the judgment is wrong, coronary perforation or rupture caused by the guide wire is a common reason for causing the most serious complications of the CTO. If the head end imaging ultrasound is applied, the position of the true lumen of the blood vessel can be guided in real time, the advancing direction of the guide wire can be guided along the true lumen of the blood vessel, and the complications in the operation are reduced. To accurately locate the stub position of the stub fuzzy CTO, the physician uses intravascular ultrasound to assist the surgeon in performing this type of procedure. However, this procedure is not applicable if the diameter of the side branch surrounding the occluded vessel is smaller than the diameter of the IVUS catheter, and is not successful if the side branch is not present around the occluded lesion. Second, current IVUS catheters do not provide information about the occluded distal vessel, and there remains a need to rely on bilateral coronary angiography to visualize collateral circulation vessels distal to the occlusion. In addition, in CTO-combined calcified lesions, such lesions can block intravascular ultrasound from judging at occluded discontinuities, interfering with the identification and judgment of the true lumen of the vessel.
Meanwhile, coronary perforation is the most common and serious complication in CTO lesion PCI surgery, and the incidence rate is 0.29-0.93%. Coronary artery rupture caused by the guide wire in PCI operation is the most common, one is the coronary artery rupture caused by the hard guide wire entering a false cavity, and the other is the rupture of a small branch at the far end caused by the hard guide wire passing through CTO lesion, which can cause delayed cardiac tamponade and cause serious consequences. At present, the special guide wires for CTO pathological changes (Conquest/Conquest pro series, Cross it series and the like) have extremely strong pathological change capability, and whether the far end of the guide wire is positioned in a true cavity or not is difficult to judge according to the resistance encountered by the guide wire and the flexible degree of head end movement. If misjudgment is made, the balloon is mistakenly used for passing or expanding, and severe coronary artery rupture is often caused.
SUMMERY OF THE UTILITY MODEL
The technical problem to be solved by the utility model is to provide an intravascular forward-looking probe.
In order to solve the technical problem, the technical scheme of the utility model is that:
the utility model provides an endovascular foresight detection device, includes endovascular foresight probe (20-60MHz), endovascular foresight probe includes shell (1a), CMUT ultrasonic sensor array (2) (be based on capacitanc supersound microarray sensor promptly), acquisition control chip (3) and flexible axle with cable (1b), outer casing (1a) is hollow cylindrical structure, CMUT ultrasonic sensor array (2) and acquisition control chip (3) inlay in shell (1a) to whole with flexible axle with cable (1b) fixed connection, and along with flexible axle with cable (1b) back-and-forth movement together.
Preferably, in the aforementioned intravascular forward-looking probing device, the CMUT ultrasound sensor array (2) includes a plurality of vibrating element ultrasound units of independent circuits, each vibrating element ultrasound unit is composed of a plurality of thin film vibrating elements (2b), and the thin film vibrating elements (2b) use CMUT thin film structures, include upper electrodes (21), diaphragms (22), cavities (23), and electrode-carrying substrates (24) connected in sequence, and are connected to the acquisition control chip (3) through the electrodes (21).
Preferably, in the intravascular forward-looking probe 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 intravascular forward-looking probe device, the package size of the CMUT ultrasound sensor array is 0.5-2 mm.
Preferably, in the intravascular forward-looking detection device, 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 amplification, 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 sequentially connected in a circulating circuit, and the receiving/transmitting control switch is connected with the CMUT ultrasonic sensor array (2) in a circuit.
Preferably, the intravascular forward-looking detection device further comprises an interventional catheter (4), the intravascular forward-looking probe is arranged in the interventional catheter, the flexible shaft (1b) with the cable is connected with a motor circuit, the intravascular forward-looking probe drives the flexible shaft (1b) with the cable through the motor, and the intravascular forward-looking probe slides forwards and backwards in the interventional catheter and is automatically withdrawn by the aid of movement of the flexible shaft (1b) with the cable.
Preferably, in the aforementioned endovascular forward-looking detection device, the interventional catheter (4) has an outer diameter of 0.5-3 mm.
Preferably, in the aforementioned endovascular forward-looking detection device, the interventional catheter (4) is an IVUS catheter.
Preferably, the intravascular forward-looking detection device further comprises an upper computer (i.e., a computer with corresponding digital signals and image processing), the upper computer is connected with the control chip of the acquisition control chip (3) and the motor through a cable, and the upper computer and the control chip perform information interactive transmission and perform real-time control on the motor.
Preferably, in the intravascular forward-looking detection device, the outer casing (1a) is made of copper or other metal materials.
Has the advantages that:
according to the intravascular forward-looking detection device, the intravascular forward-looking probe comprises a group of forward-looking CMUT ultrasonic sensor arrays, so that forward-looking ultrasonic imaging with high resolution and large scanning angle can be realized. The clinical significance of the method is that the forward imaging can be carried out at the far end of the catheter head end, so that the catheter does not need to enter a side branch to advance or retract the catheter, the accurate position of a guide wire in a coronary artery can be observed in real time, the guide wire in a false cavity can be guided to enter a true cavity again, in some flush occlusion lesions, clear CTO entrance information can be provided, lesions at the near end of an occlusion vessel can be observed visually, and a real-time roadmap of the occlusion vessel can be provided in PCI. Through the information provided by the intravascular forward-looking probe, the running direction and position of the guide wire in the blood vessel are fully known, the running direction of the blood vessel cavity is determined, and sufficient information is provided for the operation of the guide wire in the operation.
The guide wire technology is the core of the CTO lesion opening in an anterior or reverse way, and the guide wire penetrates through plaque tissues of a CTO occlusion section from a proximal blood vessel true cavity to enter a distal blood vessel true cavity, so that the CTO lesion opening guide wire is an ideal target for interventional CTO opening. Although the guide wire enters the subintimal or 'false cavity' and then enters the true lumen of the blood vessel (including ADR and reverse CART) from the 'false cavity' to open and block the blood vessel, after the guide wire passes through the subintimal or 'false cavity', if the guide wire passes through the subintimal or the adventitial, the possibility of concurrent coronary perforation and even cardiac tamponade exists, therefore, the invention utilizes the unique image advantage of the forward-looking probe in the blood vessel to track the shape and position of the guide wire at any time, reduce the blind shape of the guide wire in the operation, and guide the operation of the guide wire in the true lumen of the blood vessel or returning the guide wire to the true lumen of the blood vessel from the false cavity when necessary, thereby improving the success rate of CTO pathological change operations, reducing the occurrence of perforation, dissection and the like of the blood vessel in the operation, shortening the operation time, reducing the X radiation amount, and also obviously reducing the dosage of the contrast medium in the operation, thereby reducing the occurrence of contrast medium nephropathy.
Drawings
Fig. 1 is a schematic structural view of an intravascular forward-looking detection device according to the present invention;
FIG. 2 is a schematic diagram of a circuit control diagram of the intravascular forward-looking probe of the present invention;
fig. 3 is a schematic structural diagram of a CMUT ultrasound sensor array of the intravascular forward-looking probing device of the present invention, including a partially enlarged view of an ultrasound unit of a vibrating element and a schematic diagram of a single membrane vibrating element (black small circle portion);
fig. 4 is a schematic diagram showing the combination of the three kinds of catheter CMUT arrays and the package housing of the CMUT ultrasound sensor array of the intravascular forward-looking probing device of the present invention.
In the figure, 1-an intravascular front-looking probe 1 a-a shell 1 b-a flexible shaft with a cable
2-CMUT ultrasonic sensor array 3-acquisition control chip 4-interventional catheter
2 a-vibrating element ultrasonic unit 2 b-thin film vibrating element 21-upper electrode
22-diaphragm 23-cavity 24-substrate with electrodes
Detailed Description
Example 1
As shown in fig. 1-4, the intravascular forward-looking detection device comprises an intravascular forward-looking probe 1(20-60MHz), wherein the intravascular forward-looking probe 1 comprises a housing 1a, a CMUT ultrasound sensor array 2 (i.e. based on a capacitive ultrasound microarray sensor), an acquisition control chip 3 and a flexible shaft with a cable 1b, the housing 1a is a hollow cylindrical structure made of copper metal, and the CMUT ultrasound sensor array 2 and the acquisition control chip 3 are embedded in the housing 1a, are integrally and fixedly connected with the flexible shaft with the cable 1b, and move back and forth along with the flexible shaft with the cable 1 b; wherein,
the package size of the CMUT ultrasonic sensor array 2 is 0.5-2mm, the CMUT ultrasonic sensor array comprises a plurality of vibrating element ultrasonic units 2a of independent circuits, the vibrating element ultrasonic units 2a are composed of a plurality of thin film vibrating elements 2b, the thin film vibrating elements 2b use CMUT thin film structures, include upper electrodes 21, diaphragms 22, cavities 23 and electrode-carrying substrates 24 which are connected in sequence, and are connected with the acquisition control chip 3 through the electrodes 21, and the shapes of the thin film vibrating elements 2b can be circular or square, and can be the same or different;
the acquisition control chip 3 comprises a pulse signal generator, a receiving/transmitting control switch with a multiplexer, a high-speed analog front end (used for amplification, filtering and analog-to-digital conversion) and a control chip, wherein the pulse signal generator, the receiving/transmitting control switch, the high-speed analog front end and the control chip are sequentially connected in a circulating circuit manner, and the receiving/transmitting control switch is connected with the CMUT ultrasonic sensor array 2 in a circuit manner;
the intravascular forward-looking detection device further comprises an interventional catheter 4 with the outer diameter of 0.5-3mm, the interventional catheter 4 is an IVUS catheter, the intravascular forward-looking probe is arranged in the interventional catheter, the flexible shaft with the cable 1b is connected with a motor circuit, the intravascular forward-looking probe drives the flexible shaft with the cable 1b through the motor, and the intravascular forward-looking probe slides forwards and backwards in the interventional catheter and is automatically withdrawn by the movement of the flexible shaft with the cable 1 b;
the intravascular forward-looking detection device further comprises an upper computer (namely, a computer with corresponding digital signals and image processing), the upper computer is connected with a control chip (the model is US7846101B2, and other chips with the same functions can be used for replacing) and a motor of the acquisition control chip 3 through cables, and the upper computer and the control chip carry out information interactive transmission and carry out real-time control on the motor.
When the device works, the intravascular forward-looking probe is electronically scanned by the acquisition control chip and can move back and forth together with the interventional catheter. The upper computer is used for controlling the acquisition control chip to receive and transmit signals and process signals/images, and the upper computer is used for controlling the automatic retraction device to realize forward and backward movement scanning of the intravascular forward-looking probe.
Specifically, a pulse signal generator of an acquisition control chip is controlled by an upper computer to generate an excitation pulse signal (analog excitation signal), and a receiving/transmitting control switch with a multiplexer triggers a CMUT sensor array at the front end to form an ultrasonic scanning sound field in the forward-looking direction; receiving ultrasonic echo signals, and reaching an upper computer through a receiving/transmitting control switch of a control chip and a high-speed analog front end (amplification, filtering and analog-to-digital conversion) to perform mathematical signal processing to obtain imaging data of the scanning direction in a forward-looking field; repeatedly changing the array elements to delay and change the direction of the scanning sound beam until the data acquisition and transmission of the whole front visual field are completed, and carrying out image reconstruction and subsequent processing on an upper computer to obtain two-dimensional and local three-dimensional images; according to the obtained image information, the clinician judges the blockage and stenosis condition of the blood vessel at the front end and determines whether the catheter advances or retreats; and moving the whole transducer backward or forward for a certain distance by retracting or advancing the catheter, repeating all the imaging processes until the acquisition of the images corresponding to different positions of a section of the blood vessel is completed, and integrating the images into three-dimensional images of all the detection areas.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, a plurality of modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (10)
1. An intravascular forward-looking detection device, comprising: the blood vessel forward-looking probe comprises an outer shell (1a), a CMUT (CMUT) ultrasonic sensor array (2), an acquisition control chip (3) and a flexible shaft (1b) with a cable, wherein the outer shell (1a) is of a hollow cylindrical structure, the CMUT ultrasonic sensor array (2) and the acquisition control chip (3) are embedded in the outer shell (1a), and are integrally connected with the flexible shaft (1b) with the cable in a fixed mode and move back and forth along with the flexible shaft (1b) with the cable.
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 shell (1a) is made of copper metal material.
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