CN112971978A

CN112971978A - Artery cleaning device

Info

Publication number: CN112971978A
Application number: CN201911280238.3A
Authority: CN
Inventors: 王�锋
Original assignee: Beijing Shanyide Medical Research Institute Co ltd
Current assignee: Beijing Shanyide Medical Research Institute Co ltd
Priority date: 2019-12-17
Filing date: 2019-12-17
Publication date: 2021-06-18

Abstract

The present invention provides an arterial cleaning device for detecting, navigating and cleaning arterial vascular plaque and vulnerable plaque. The device includes: the device comprises a wire guide device, a steering device, a diode controller and a computer system. The purpose is to detect and remove vulnerable and non-vulnerable plaque or blockages in arterial vessels. And enables these occlusions to be safely moved, diverted and cleaned. The artery cleaning device is based on a special laser ultrasound technology (laser acoustic sensor) that will be combined with a computer system and an opening device. The imaging device of the computer system may present a (three-dimensional) image on the computer and navigate the vascular guidewire to the vascular occlusion according to the image processing results. So as to detect the blockage of the blood vessel and achieve the aim of safely removing the obstacles.

Description

Artery cleaning device

Technical Field

The present invention relates generally to the field of treatment of vascular occlusions. And more particularly to a device for safely detecting, navigating and cleaning arterial occlusions.

Background

In recent years, heart diseases, particularly Coronary Artery Disease (CAD), are a major cause of death, disability, and the like. The main cause of morbidity in most patients with heart disease is coronary artery occlusion, i.e. the presence of plaque in the coronary arteries. These plaques progressively increase causing narrowing of the coronary arteries and thus angina pectoris. Narrowed or occluded arteries reduce blood flow, causing the accumulation of platelets to form clots. Clots can block the flow of oxygen-enriched blood to the heart muscle, causing a heart attack. Clots may also form and migrate in other organs (e.g., the brain), causing the accumulation of platelets to form a thrombus, blocking blood vessels. In severe cases, cerebral infarction can be caused.

Over the past decade, paradigms have emerged in which accumulation of hard plaque in the coronary arteries can cause patients to develop angina or to develop atherosclerosis, coronary artery disease and heart attacks due to severe ischemia. New clinical data now indicate that non-occlusive, rupture of vulnerable plaque leads to heart attack rates as high as 60% -80%. In general, vulnerable plaque is not easily detected by conventional angiography or fluoroscopy techniques. Vulnerable plaque patients in blood vessels often do not have adverse reactions, so vulnerable plaque can be more dangerous than other plaque causing body pain.

Atherosclerotic plaques that are prone to rupture are usually small deposits covered by a thin fibrous cap (less than 70 microns) of the lipid core. The fiber cap is filled with compact infiltration solution of smooth muscle cells, macrophages and lymphocytes. The lipid pool is formed by pathological processes of Low Density Lipoprotein (LDL), macrophages and inflammatory cells. The macrophages oxidize the LDL to generate foam cells. Macrophages, foam cells and smooth muscle cells are located beneath the endothelium and release various toxic substances such as tumor necrosis factor and tissue factor. These substances damage the arterial wall and surrounding area, resulting in cellular necrosis of the fibrous cap. The inflammatory process weakens the fibrous cap to a sufficient mechanical stress, for example, the impact forces generated by elevated blood pressure can cause it to rupture, and the contents of the lipid core and vulnerable plaque (emboli) flow into the blood, thereby initiating the coagulation cascade. The cascade may result in a heart attack or stroke in the patient.

Several methods for detecting or diagnosing vulnerable plaque have been developed. One is to detect vulnerable plaque: by measuring the temperature within the vessel. As the temperature of vulnerable plaque tissue is typically higher compared to healthy vascular tissue. This measurement of temperature difference can be used to detect vulnerable plaque. The other is to mark vulnerable plaque: the labeling substance may be attractive to the vulnerable plaque or may react in some way with the vulnerable plaque. For example, the markers are more easily attracted to vulnerable plaque than to healthy tissue, thereby achieving a detection effect. Or the marker will simply change properties while in contact with the vulnerable plaque. Vulnerable plaque can be detected by detecting a change in the property. Regardless of the method of detection, great difficulties remain in treating vulnerable plaque. Without proper treatment, vulnerable plaque can rupture and release embolic material, causing significant harm to the patient's body. It may reduce the chance of vulnerable plaque rupture over a relatively long period of time by drug or other therapy. But these treatments may be ineffective for all patients. As rupture of these vulnerable plaques may occur at any time.

It is therefore desirable to have a device that can safely remove vulnerable and hard plaques, such as removing occlusions of coronary or other peripheral arteries. While any potential vulnerable plaque and its ruptured escaping embolic material can be periodically examined to reduce the risk of the patient becoming ill.

Disclosure of Invention

The present invention provides an arterial cleaning device for detecting, navigating and cleaning arterial vascular plaque. The device includes: the device comprises a wire guiding device, a steering device, a secondary pipe controller and a computer system.

The guidewire device includes a first vascular guidewire device and a second vascular guidewire device. The first blood vessel wire guiding device mainly comprises a wire guiding head and a laser-acoustic sensor. The second blood vessel wire guiding device mainly comprises a wire guiding head and an opening device. A steering device is placed in the thread guide for changing the direction of the thread guide head. The vascular guide wire has a diameter of 1-3 mm. First and second vascular guidewire devices are for insertion into a blood vessel on opposite sides of a patient's blood vessel for detecting, navigating and cleaning arterial occlusions.

The laser-diode controlled by the laser-diode controller is connected to the laser-acoustic sensor via an optical fiber passing through the guide wire device and provides laser pulses thereto. The frequency of the laser pulses is determined by the laser diode controller. The computer system is connected via electronic communication to the laser-acoustic sensor, continuously receiving its laser and ultrasonic signals. Wherein the optical fiber is wirelessly connected to the laser diode.

The computer system includes a computer and an imaging device. The computer system may image 2-5 centimeters forward within the patient's artery in order to guide the vascular guidewire to safely move to the patient's arterial occlusion. The computer system may control the frequency of the laser diode pulses based on the type of material identifying the arterial occlusion or plaque or based on measuring the distance of the guidewire tip from the vessel wall. Wherein the computer is electrically connected to the laser diode controller.

The imaging device includes an image processing device and a display device. The imaging device can distinguish the true luminal path from the luminal path of the occluded segment, wherein the imaging of the occluded segment is both anterior and lateral to the occluded vessel. The image processing device and the laser-acoustic sensor can present the artery occlusion scene in real time, namely 3D imaging of the artery 2-5 cm ahead on the display.

The steering device includes first and second steering devices for the first and second vascular guidewires. The first steering device is connected with the wire guide head and can navigate the laser-acoustic sensor according to the image processing result of the computer system. The first steering device may change its path through the arterial occlusion by changing the orientation of the laser acoustic sensor.

The method for changing the direction of the godet head by the steering device comprises the following steps: two superelastic filaments in the steering device may be connected to the laser-acoustic sensor, which may change the direction of the guidewire tip when the filaments are pulled outside the patient's body; two superelastic threads of the steering device are connected at one end to an external control knob by a flexible articulation and at a second end to the guidewire head. Wherein the flexible joint is a metal ball spanning the elastic guide wire, wherein the micro-arms of the steering device can be connected to the guide wire head, and each of the micro-arms needs to be connected to a corresponding one of the super-elastic threads.

The second blood vessel wire guiding device mainly comprises a wire guiding head and an opening device. The second diverting means and the opening means can be used to clean the occlusion of the artery. The laser-acoustic sensor and the opening means are built using MEMS (micro electro mechanical systems) technology.

The opening device comprises at least one micromechanical tool that is navigated by the steering device. The opening means includes a low power laser sound capable of melting the closure cap. The micromechanical tool may comprise one of: radiofrequency, ultrasound, and blunt microdissection.

The vascular guidewire device may further comprise an energy management device, wherein the energy management device may be used to provide pre-translation of the laser acoustic pulse rate.

The invention has the beneficial effects that: the artery cleaning device can achieve the aim of directly cleaning the blood vessel blockage, and the risk of morbidity or mortality of a patient is fundamentally reduced by reducing the medicine intake of the patient.

Drawings

Figures 1A-1B schematically illustrate an artery cleaning device in accordance with an embodiment of the invention;

FIG. 2 schematically illustrates an exemplary steering device of a guidewire device according to an embodiment of the invention;

FIG. 3 schematically illustrates an exemplary resilient structure of a catheter in accordance with an embodiment of the invention;

FIG. 4 schematically illustrates another exemplary steering device of a guidewire device according to an embodiment of the invention;

FIG. 5 schematically illustrates another exemplary steering device of a guidewire device in accordance with an embodiment of the present invention;

6A-6C schematically illustrate an exemplary occlusion break tool used in accordance with embodiments of the present invention;

FIG. 7 schematically illustrates an exemplary method of placing a laser acoustic sensor into an obstruction in accordance with an embodiment of the invention;

FIG. 8 illustrates a 3D image representing different material densities detected by a recognition system in accordance with an embodiment of the present invention;

FIG. 9 schematically illustrates an aggregation of pixels for identifying random areas of different materials in accordance with an embodiment of the invention;

FIG. 10 schematically illustrates a neural network architecture for material identification in accordance with an embodiment of the present invention.

Detailed Description

The invention is described in further detail below with reference to the examples of the drawings. The present invention provides a device for scanning and cleaning of arteries, such as coronary arteries, peripheral arteries, of a patient. The device consists of a computer controlled vascular guidewire device that performs cleaning of the vessel wall by removing accumulated plaque or arterial occlusion. This plaque or other type of obstruction can cause atherosclerosis, arterial obstruction and ultimately lead to heart attack or stroke. Initially, a vascular guidewire device is inserted into a human blood vessel and guided within the interior thereof. The vascular guidewire device is based on a laser-acoustic sensor in electronic communication with a computer imaging system, and an opening device. The occluded area is found and the occlusion removed without damaging the tissue of the vessel. Vascular guidewires use full imaging to search for and clean occlusions in the vessel.

The vascular guidewire device also includes a device for removing and collecting removed plaque or any other occluding material. The device realizes safe and efficient blood vessel cleaning, and provides an innovative non-operative method for removing blood vessel blockage. The device can be safely moved into any occluded artery, primarily by using innovative safe navigation into the lumen, special steering, debris cleaning and removal techniques. The device includes an integration of multiple methods of efficient mechanical steering, effective micromechanical tools to safely clear the occluded artery while penetrating the occlusion in the right lumen.

In order for the vascular guidewire device to reach the site of the arterial occlusion and perform visualization operations, the first and second vascular guidewire devices must reach the site of the occlusion simultaneously. The various tools described above are integrated into a vascular guidewire, where the guidewire is 1-3mm in diameter.

Figure 1A shows an artery cleaning device in accordance with an embodiment of the invention. Wherein the system 100 includes a guidewire having a guidewire tube 110, a guidewire tip 120, a guidewire tip 130, the guidewire tip 130 including a laser-acoustic sensor 135. A laser diode 160 controlled by a laser diode controller 170 is connected to and provides laser pulses to the laser-acoustic sensor 135 via an optical fiber 180. The frequency of the laser pulses is determined by laser diode controller 170, and the laser pulses may also be varied in a program of computer system 140 or during investigation according to conditions (e.g., density of identified material).

Computer system 140 is connected to laser-acoustic sensor 135 via electronic communication 150 and continuously receives its laser and ultrasonic signals. The signals are processed by an image processing device, as described in detail below. Computer system 140 is electrically connected 165 to laser diode controller 170.

FIG. 1B is a schematic top view of the guidewire device showing the guidewire head 120, the laser-acoustic sensor 135 and the holes (openings) 190, which holes (openings) 190 are the entrances for various cutting, drilling and debris collection tools. The method specifically comprises the following steps: using a superelastic (e.g., 0.1mm or less) thin wire to change the direction of the guidewire tip can achieve a variety of effective methods for steering the guidewire within a vessel. Other methods may include, for example, the use of pneumatic or hydraulic microactuators.

Fig. 2 schematically illustrates an exemplary steering device for a guide wire device, including two superelastic filaments, such as made of nickel titanium, connected to a head 420 of the guide wire.

Wires

430, 440 pass through catheter 450 and may be connected to handle 460 on the other side thereof. Pulling one or both of the wires from outside the body (by bending the handle) will change the direction of the guidewire tip. The handle 460 may be rotated at will and may also be used to guide other tools, such as a drilling or cutting tool to a desired location.

Fig. 3 schematically illustrates the resilient structure of a catheter 450 in an embodiment in accordance with the invention. The superelastic wire passes through the catheter wall. The pull wire bends the tube in the direction of the pull wire. The second wire may be threaded on the opposing wall to enable the tube to bend in the opposite direction. The tube may be made of any suitable resilient material such as plastic or nickel titanium.

Fig. 4 schematically illustrates other exemplary steering devices of a guidewire device according to embodiments of the present invention. The

small arms

470, 480 are attached to the sides of the rotating guidewire head 490 and are attached to the outside of the body by two

superelastic threads

475, 485, respectively. Pulling the wire will change the inclination of the godet and thus the orientation of the laser acoustic sensor.

In another embodiment, a pneumatic or hydraulic microactuator may be used to manipulate the guidewire. The hydraulic conduits do not affect the operation of the scanner as they are driven by fluid pressure in the sides of the conduits. Increasing the pressure bends the catheter away from the compression tube. Wherein the hydraulic catheter extends on either side of the catheter to the catheter tip, wherein the one or more steering lumens are offset from the longitudinal axis of the catheter, bending the catheter. In this embodiment, the direction of the conduit may be changed by using a pneumatic or hydraulic pressure source or by heating a thermally expansive material that fills the diverting lumen.

Fig. 5 schematically illustrates other exemplary steering devices for a guide wire device according to embodiments of the present invention, wherein a resilient guide wire 500 is connected at one end thereof to an external control knob 510 by a flexible joint 520 of a metal ball 530, which allows the drive shaft to emit power at a constant rotational speed and variable angle. The other end of the elastic guide wire 500 is connected to the tip of the guide wire head. The orientation of the headpiece to the right lumen can be changed by the knob pushing on the flexible guidewire when the surgeon wants to do any given moment.

Fig. 6A-6C schematically show an exemplary micromechanical tool, i.e. an opening device, used in the device according to the present invention. Opening the fibrotic and focused calcified matter accumulated in the vessel is accomplished by using mechanical or alternative energy (laser, radio frequency, ultrasound, blunt micro-dissection) or the like. Each of the micromechanical tools must provide x and y motion, tilt, advance and retract, and activate the cutting or drilling motion.

The micromechanical methods of opening the occlusion include drilling, spinning, cutting and the like methods that safely open and clean the occlusion. The micromechanical cutting device may comprise, for example, a drill bit. Other cutters or grippers are optional. There is sufficient space in the catheter for access to 2 or 3 tools such as cutters and debris collectors.

The safety cap of fig. 6A is mounted on a rod (or wire) 620 and inserted into the conduit through one of its holes (openings) 630 and pushed backward (in (-) direction) and rotated by pushing the rod 620 forward (in (+) direction). Operation allows rotation and stroke (+)/(-) as indicated by arrow 640. The boring tool is a round pin file insertable into the safety cap, which can limit the cutting depth, thereby improving safety.

The tool shown in fig. 6B shows another drilling tool. The tool of fig. 6C shows a vise or clamping tool. Another method of opening is to safely melt the closure cap using low power laser-acoustics (to prevent overheating).

FIG. 7 schematically illustrates an exemplary method of placing a laser acoustic sensor into an obstruction in an embodiment in accordance with the invention. The method aims to reduce the profile of the laser acoustic sensor, thereby realizing the puncture of the blood vessel. As shown, the sensor array is inserted into the inner tube in a collapsed position and then deployed using a superelastic wire. The catheter, laser acoustic sensor, and various cutting or drilling tools may be constructed using micro-electromechanical systems (MEMS) technology. As it can provide the desired miniaturized, visualized access into the occluded artery. It possesses the ability to safely navigate a vascular guidewire device to an arterial occlusion, providing safety for opening and cleaning of the entire occlusion.

One of the most effective implementations of laser acoustic techniques is to measure distance, such as from the vessel wall, to obtain information in the micrometer, nanometer range with precision. The single plane acoustic wave is generated by thermoelastic interaction of a homogeneous nanometer secondary pulse laser beam on the top of the sensor through a liquid-solid interface. Laser flash image processing is used to visualize transient interactions of planar acoustic waves with various submerged rigid or soft structures. The transient interaction of the sound waves is analyzed, the distance of micron and nanometer areas can be accurately measured, and vision is provided to the front of the shelter. Laser ultrasound technology has been widely used to measure acoustic wave motion at very high frequency (gz-THz) surfaces.

The computer system assembles the images of the material into individual particles and determines the properties of the particle boundaries within measurements for all planar directions that need to be satisfied. The imaging technology greatly accelerates the measuring process and can quickly identify the depth and the length. Further, the imaging method can measure the material particle size based on the UHF detection to determine the amount and thickness of the material within the detection object. This type of plugging material can be determined by dynamic holographic image processing as well as by plugging identification within the curved tube. The method uses a non-linear optical material for optical excitation and transport of charge carriers and uses pre-translation of the laser acoustic pulse rate to save energy from diffraction gratings or holographic images produced inside the optical material. The steerable laser-acoustic sensor is driven all the way to the occlusion region. The physician can accomplish arterial cleaning by selecting tools, determining the location of the cut or bore, and estimating the length and thickness of the occlusion.

FIG. 8 illustrates a 3D image of different density materials detected by a pattern recognition system using frequency deflection and acoustic distribution, represented in accordance with an embodiment of the present invention. The materials include arterial walls, blood and clot materials.

FIG. 9 illustrates an aggregation of pixels for identifying random regions of different materials, according to an embodiment of the invention: adjacent pixels with similar attributes are clustered into tiles. Adjacent patches with similar features are aggregated into a patch feature. Fig. C is a map created of various image features (areas). The device is thus able to distinguish the true luminal path from that of the occluded segment and image the anterior and lateral aspects of the occluded vessel wall.

FIG. 10 schematically illustrates a neural network architecture for material identification in accordance with an embodiment of the present invention. The architecture includes a depth feed means for identifying a neural network architecture for the forward direction from pixel material. The invention aims to provide a novel recurrent neural network architecture for up-and-down propagation. It first maps the image into an image processing space, and then maps a top-down aggregation of local information into the global of the entire image. The aggregated information is then propagated from top to bottom, which enhances the timeliness of context information delivery for each local feature. Thus, information from each location in the image can be propagated to every other location. Experimental results show that the method provided by the invention is efficient and rapid. A superpixel mask is provided that takes only 0.07 seconds per pixel on a GPU (graphics processing unit) when constructing an RGB image with a pixel value of 256x 256.

According to an embodiment of the invention, the first vascular guidewire has the function of laser-acoustic imaging and the second vascular guidewire has the function of opening a vascular occlusion. The first catheter is similar to the catheter described in fig. 1A and includes a guidewire. A second catheter is inserted into the patient's vessel from the opposite side of the occlusion after being identified by the imaging system. The second catheter is used to insert a cleaning device as described in connection with fig. 6A-6C, steered using any of the steering methods described above, and navigated in connection with fig. 2-5. The second catheter is navigated to the occlusion area according to the imaging results of the image processing device, thereby performing arterial cleaning.

Claims

1. The artery cleaning device includes: the wire guiding device comprises a first blood vessel wire guiding device and a second blood vessel wire guiding device, wherein the first blood vessel wire guiding device mainly comprises a wire guiding head and a laser-acoustic sensor, and the second blood vessel wire guiding device mainly comprises a wire guiding head and an opening device; a steering device is placed in the thread guide device for changing the direction of the thread guide head; the laser-diode controlled by the laser-diode controller is connected with the laser-acoustic sensor through an optical fiber passing through the wire guide device and provides laser pulses to the laser-acoustic sensor; the computer system is connected to the laser-acoustic sensor through electronic communication, continuously receives laser and ultrasonic signals of the laser-acoustic sensor, and safely navigates the blood vessel guide wire to the artery occlusion part according to the image processing result of the computer; an opening device is connected to the guidewire head for opening a total occlusion of the artery.

2. The vascular guidewire device of claim 1, having a diameter of 1mm to 3 mm.

3. The vascular guidewire device of claim 1, wherein the connection of the optical fiber to the laser diode is wireless.

4. The vascular guidewire device of claim 1, wherein the computer is in electrical communication with a laser diode controller.

5. The vascular guidewire device of claim 1, wherein the steering device comprises two superelastic filaments connected to the laser acoustic sensor, the filaments characterized by: the direction of the guidewire tip can be changed as the physician pulls the thread from outside the patient's body.

6. The laser-acoustic sensor of claim 1, wherein: can be used for receiving the laser pulse transmitted by the diode controller and sending the laser and ultrasonic signals to the computer.

7. The steering device according to claim 1, wherein: the steering device is connected with the guide wire head and can be used for changing the direction of the laser-acoustic sensor according to the image processing result of the computer system and correcting the deviation of the expected path and the actual path of the laser-acoustic sensor passing through the artery occlusion.

8. The computer system of claim 1, comprising a computer and an imaging device, wherein: the computer system can image 2-5 centimeters forward within the patient's artery and can be used to guide the vascular guidewire to safely move to the patient's arterial occlusion.

9. A computer system according to claim 8, wherein the imaging system is operable to distinguish a true luminal path from a luminal path of an occluded segment, wherein the imaging of the occluded segment is anterior and lateral imaging of the occluded vessel.

10. The computer system of claim 8, wherein the imaging system is characterized by: can be used to distinguish the type of occluding material and can also continuously measure and provide the distance of the laser-acoustic sensor from the vessel wall.

11. The guidewire head according to claim 1, wherein said guidewire head is rotatable and steerable and wherein said steering means includes micro-arms attached to said guidewire head, each of said micro-arms being attached to a respective one of said superelastic filaments.