Puncture guide wire with foresight detection and penetration functions and intelligent intervention system

Abstract

The invention provides a puncture guide wire with foresight detection and penetration functions and an intelligent intervention system, and belongs to the technical field of medical minimally invasive intervention instruments. The energy conversion assembly is innovatively integrated at the head end of the puncture guide wire, and the dual functions of A-type ultrasonic foresight detection and ablation are achieved through electric or optical path driving. The system supports two implementation modes: in an electroacoustic mode, a piezoelectric micro-electro-mechanical system is used for realizing ultrasonic transceiving and ablation; in the opto-acoustic mode, ultrasonic waves are generated by utilizing the opto-acoustic effect of the optical fiber, echoes are detected by utilizing optical interference, and ablation is performed by utilizing high-energy laser or ultrasonic waves. According to the invention, blood vessel, heart and occlusion lesions are identified based on a waveform fingerprint algorithm of time domain echoes, and a high-energy mode can be dynamically switched to assist in penetrating tissues. The problems that in an existing minimally invasive interventional operation, in-vitro image guiding precision is insufficient, a traditional IVUS / ICE catheter is too large in size and high in cost, and a traditional guide wire lacks active detection and auxiliary penetrating capacity when facing complex lesions are solved.

Description

Technical Field

[0001] This invention belongs to the field of minimally invasive medical interventional device technology, and in particular relates to a puncture guidewire and intelligent interventional system with forward detection and penetration functions. Background Technology

[0002] In interventional radiology and cardiology, precise puncture is crucial for surgical success. Current puncture-aid techniques primarily rely on external ultrasound guidance or X-ray fluoroscopy. However, existing techniques have the following limitations:

[0003] 1. Large size of external ultrasound probe: When performing punctures in delicate areas or deep tissues, the external probe is often interfered with by bones or gas, making it impossible to clearly display the puncture path.

[0004] 2. Difficulty in guiding special sites: For example, when performing procedures such as atrial septal puncture and pericardiocentesis, doctors need extremely high precision; traditional in vitro imaging cannot provide microscopic tissue information in front of the needle tip.

[0005] 3. Expensive equipment: Although intravascular ultrasound (IVUS) and intravascular ultrasound catheters (ICE) can provide clear images, their catheter diameters are relatively large, and the cost of the equipment and consumables is extremely high, making them unsuitable as routine puncture guidance tools. Furthermore, clear ultrasound imaging technology relies on a large number of imaging arrays, which cannot be truly miniaturized; for example, it cannot be integrated onto a guidewire as small as 0.014 inches.

[0006] 4. Lack of active penetration capability: Traditional guidewires only play a supporting and guiding role. When encountering calcified or tough tissues (such as through a hard atrial septum), it is difficult and risky to puncture by mechanical force alone, and cannot achieve the functions of "checking" and "punishing" at the same time.

[0007] In particular, chronic total occlusion (CTO) lesions are referred to as the "last bastion" in interventional vascular surgery. When passing through CTO lesions, current guidewires often rely on the surgeon's touch and are "blindly tested," which can easily lead to vascular dissection or puncture of the vessel wall. While existing devices such as shockwave balloons can assist in the passage, they lack the "eyes" to distinguish between hard plaque and normal vessel wall. Summary of the Invention

[0008] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a puncture guidewire and intelligent intervention system with forward-looking detection and penetration functions, in order to solve the problems of insufficient accuracy of extracorporeal image guidance, excessive size and high cost of traditional IVUS / ICE catheters, and lack of active detection and assisted penetration capabilities of traditional guidewires when facing complex lesions (such as CTO and tough septa) in existing minimally invasive interventional surgery.

[0009] Based on different clinical needs, this invention provides two specific implementation paths: an electrical path (suitable for routine use) and an optical path (suitable for minimally invasive procedures and MRI environments, where the MRI environment specifically refers to the strong physical field space generated and affected by the operation of magnetic resonance imaging equipment and its surrounding control area).

[0010] Specifically, the purpose of this invention is to provide a puncture guidewire with forward-looking detection and penetration functions. This guidewire can identify the tissue properties in front of the needle tip ("seeing the path") in an extremely small space (such as an interventional channel of 0.014 inches) using a single beam or low-dimensional energy form (such as A-mode ultrasound or photoacoustic signal). After confirming the lesion type, it can, if necessary, use the same channel to transmit high-power energy for tissue ablation or destruction ("opening the path"), thereby improving the safety, success rate and efficiency of puncture.

[0011] To achieve the above objectives, the present invention provides a puncture guidewire with forward detection and penetration functions, comprising: The guidewire body has a head end and a tail end, and an internal energy transmission channel. The outer diameter of the guidewire body is D, 0.010in≤D≤0.038in, that is, the outer diameter of the guidewire body is strictly adapted to the minimally invasive interventional specifications of 0.010 inches to 0.038 inches (preferably 0.014 inches or 0.038 inches) to ensure that it can enter extremely small blood vessels or tissue spaces. An energy conversion component is installed at the head end of the guidewire body; The end of the guidewire body receives photoelectric signals, which are then transmitted to the energy conversion component via the energy transmission channel. The energy conversion component converts the received photoelectric signals into a single sound beam and emits it in the direction of the guide wire body's movement.

[0012] That is, the energy conversion component is configured to perform the following two functions through a single or integrated functional module: Detection function (forward navigation): The excitation energy input from the tail end of the guidewire body through the energy transmission channel is converted into an ultrasonic beam emitted in the direction of the guidewire's travel (forward), and the reflected echo signal from the tissue in front is received; this signal reflects the acoustic impedance difference of the tissue in front, which is one-dimensional depth information.

[0013] Penetration function (assisted opening): Converts the high-power energy input through the energy transmission channel into energy for physical destruction of the tissue ahead, thereby assisting the guidewire in passing through hard tissue or calcified lesions.

[0014] To increase safety after puncture, the tip of the guidewire body can be pre-molded or flexible as needed.

[0015] This invention provides two specific implementation paths: Electrical solution: The energy conversion component uses a miniature piezoelectric transducer, such as PZT (piezoelectric ceramic), CMUT (capacitive micromechanical ultrasonic transducer), or PMUT (piezoelectric micromechanical ultrasonic transducer), and the energy transmission channel uses a micro coaxial cable or flexible circuit board.

[0016] When performing the detection function, the energy conversion component, namely the ultrasonic transducer, emits A-mode ultrasonic pulses and uses the echo time and intensity to determine the tissue structure.

[0017] When performing the penetration function, the energy conversion component emits high-power continuous ultrasound or high-energy pulse trains, using the mechanical (shattering), cavitation, or thermal effects of ultrasound to ablate the tissue in front.

[0018] Optical solution: The energy conversion component includes a photoacoustic generation layer and an optical interference sensing unit, and the energy transmission channel is one or more optical fibers.

[0019] When performing the detection function, it uses pulsed laser to excite ultrasound based on the photoacoustic effect, and detects weak echoes through Fabry-Perot interference or fiber Bragg grating (FBG) principles.

[0020] When performing the penetration function, high-energy continuous laser (CW Laser) is directly transmitted through optical fiber, and the tissue is directly vaporized or eroded by photothermal effect.

[0021] Based on the puncture guidewire with forward detection and penetration function described above, the present invention provides an intelligent intervention system, including the puncture guidewire, a control module and a display, wherein the control module includes an energy generation module and a signal receiving and conversion module. The energy generating module emits photoelectric signals to the tail end of the guidewire body; The signal receiving and conversion module receives the echo signal of a single sound beam emitted by the energy conversion component, analyzes and converts it, and outputs the analyzed and converted signal to the outside. The display shows the information output by the signal receiving and conversion module and enables human-computer interaction.

[0022] Before describing the logical judgments performed by the signal receiving and conversion module based on one-dimensional echo signals, we need to understand that different human tissues have different echo characteristics. For example, blood vessels may have a "peak-valley-peak" acoustic signature, meaning that the high-echoic vessel walls are interspersed with low-echoic or even anechoic valleys. In arteries, myocardium, and other pulsating organs, the echoes have a pulsating characteristic, which can greatly help doctors determine the tissues and organs ahead of the puncture path, thereby increasing the safety and success rate of the puncture. Generally speaking, the puncture needle's path can be understood as a linear one-dimensional structure over a short distance, and A-mode ultrasound can already satisfy the identification of tissue types in one-dimensional structures, while greatly reducing the cost of guidewires. At the same time, the integration of a single sound beam can meet the limitations of high integration on the size of components. Significant progress has been made in current ultrasonic generation modes, ultrasonic module technologies, and processes. Under current commercial and laboratory conditions, ultrasonic transducers (especially high-frequency transducers) as energy conversion components can be made at the micrometer (μm) level. In particular, the use of fiber optic ultrasound can achieve even smaller volumes, thereby meeting process requirements. This is the basis for the energy conversion component of this invention to convert the received photoelectric signals into a single sound beam and emit it in the direction of the guide wire body.

[0023] Based on this, we describe the logical judgments performed by the signal receiving and conversion module based on the one-dimensional echo signal: Vessel identification: By detecting whether there is a characteristic "high-low-high" amplitude sequence in the echo signal (corresponding to the acoustic impedance changes of "anterior wall-lumen-posterior wall"), it is confirmed whether the guidewire is aligned with the vessel lumen.

[0024] Pulse recognition: Continuously monitor the time axis changes of the echo signal peak. If a rhythmic displacement synchronized with the cardiac cycle is detected, it indicates that there is an artery or heart-related tissue in front.

[0025] Occlusion identification and safety interlock: When the system detects a strong reflected signal at extremely close range (e.g., <1mm in front of the needle tip) without pulsation, it is identified as a static hard lesion (e.g., CTO calcification). Only when this determination is met will the system unlock the control privileges of the "penetration function," allowing the doctor or the system to automatically trigger high-energy output to prevent accidental damage to normal blood vessel walls.

[0026] As can be seen from the above technical solution, compared with the prior art, the present invention has the following significant beneficial effects: Miniaturization and high integration: This invention abandons complex phased array imaging technology and innovatively adopts the A-mode ultrasound (or single-point photoacoustic) principle. This one-dimensional detection method significantly reduces the requirements for the number of transducers and cables, enabling the technology to be successfully integrated into the tip of a guidewire as thin as 0.014 inches (approximately 0.36 mm) or even thinner, solving the problem that traditional IVUS / ICE catheters cannot enter extremely thin blood vessels or completely occlude lesions.

[0027] "Integrated Inspection and Penetration": This invention breaks through the limitation of traditional guidewires serving only as mechanical support tools, creatively combining "forward detection" and "assisted penetration" on the same instrument. Doctors no longer need to frequently exchange instruments (such as using an IVUS catheter to inspect first, then switching to a rigid guidewire to probe), and can complete path confirmation and lesion opening on the same guidewire, significantly shortening operation time and reducing operational complexity.

[0028] Extremely high cost-effectiveness: Compared to imaging catheters that rely on dozens or even hundreds of array elements, the single-beam detection structure of this invention is extremely simple, with a mature manufacturing process, significantly reducing production costs. This makes this intelligent guidewire a potential "consumable-like" tool, reducing the economic burden on patients and the medical system.

[0029] Intelligent safety features: Through a feature recognition module and logical interlocking, the system can distinguish between the vessel wall, vessel lumen, and hard calcifications. In particular, the "pulse recognition" function effectively prevents serious complications such as perforation or cardiac tamponade caused by guidewire mispuncture. High-energy penetration mode is only allowed when a hard lesion is confirmed, greatly improving the safety of high-risk procedures such as CTO recanalization.

[0030] Precise forward-looking capability: Unlike the macroscopic perspective of in vitro imaging, this invention provides one-dimensional "microscopic touch" at the needle / guidewire tip. When puncturing key anatomical structures such as the atrial septum and pericardium, it can clearly distinguish the "peak-valley-peak" structure, helping doctors obtain accurate depth feedback during blind puncture operations and achieve precise puncture. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of an intelligent intervention system.

[0032] Figure 2A This is a schematic diagram of a puncture guidewire with forward-looking detection and penetration capabilities.

[0033] Figure 2B This is a cross-sectional view of a puncture guidewire with forward-looking detection and penetration capabilities.

[0034] Figure 3 This is a schematic diagram of the procedure for vascular puncture using a guidewire. Figure 4 This is a schematic diagram of pericardiocentesis using a guidewire. Figure 5 This is a schematic diagram of atrial septal puncture using a guidewire. Figure 6 This is a schematic diagram illustrating the use of guidewires to detect occluded blood vessels and fragment plaques, thereby assisting in opening occluded blood vessels. Component designation explanation Guide wire body 1, energy conversion component 2. Detailed Implementation

[0035] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0036] Figure 1 An intelligent intervention system provided in this application embodiment includes three parts: A puncture guidewire with forward-looking detection and penetration capabilities: This guidewire includes: The guidewire body 1 integrates an energy conversion component 2, namely an ultrasonic emission module. The energy conversion component 2 can operate using an electrical or optical scheme. It obtains acoustic information of the tissue at a certain depth in front of the guidewire by emitting forward ultrasound, thereby determining the tissue structure in front of the guidewire.

[0037] Control Module: The control module includes at least two sub-modules: Energy Generation Module: Depending on the energy generation method, this can be an electrical pulse generator, a laser pulse generator, or both. It can generate pulses of different energies and frequencies according to the detection or penetration requirements. Signal Reception and Conversion Module: This module receives, analyzes, and converts signals reflected from the preceding tissue before outputting them. The output can be to an AI module, which determines the type of preceding tissue and autonomously switches the energy type; or it can be to a display showing the acoustic signature information of the preceding tissue, allowing the operator to make their own judgments and adjust the mode. The output modules are compatible and can operate simultaneously.

[0038] Display: Used to show the organization's voiceprint information and facilitate human-computer interaction.

[0039] The following sections introduce two working modes of puncture guidewires with forward-looking detection and penetration functions: electrical and optical schemes.

[0040] (1) Electroacoustic wire based on piezoelectric / MEMS technology Structural description: Specifications of guidewire body 1: outer diameter 0.035 inches (0.89 mm) or other.

[0041] Energy conversion component 2: The guide wire tip integrates a miniature PMUT (piezoelectric micromechanical ultrasonic transducer) chip, such as 0.2mm × 0.2mm in size.

[0042] Connection method: Micron-sized cables are wound around the guide wire mandrel, and the outer layer is covered with a biocompatible polymer layer.

[0043] Workflow: Performing the detection function: The energy generation module of the control module sends electrical pulses, and the energy conversion component 2 emits ultrasound to detect the acoustic information of the tissue in front.

[0044] Perform ablation function (optional): The energy generation module of the control module outputs a high-energy pulse, and the transducer generates a high-intensity sound pressure, which uses cavitation bubbles to destroy the tissue in front.

[0045] (2) Photoacoustic guidewire based on all-fiber technology Structural description: Guide wire specifications: outer diameter 0.014 inches (0.36 mm) or even finer.

[0046] Core component: There are no metal wires inside the guide wire. The main body is a single-mode optical fiber with a diameter of 125μm, and the outer layer is wrapped with a metal braid to provide torsion control.

[0047] The head end structure of guidewire body 1: The optical fiber is coated with a photoacoustic conversion film with a thickness of about 10-20 μm on the end face of the guide wire body 1, which is used to emit ultrasonic waves.

[0048] The fiber is located on the end face of the guidewire body 1, where a Fabry-Perot (FP) interference microcavity is prefabricated to receive the echo signal of the emitted ultrasonic wave.

[0049] That is, the photoacoustic conversion film and the Fabry-Perot (FP) interference microcavity constitute the energy conversion component 2.

[0050] Workflow: Performing the detection function: The energy generation module of the control module emits nanosecond pulse lasers, and the photoacoustic conversion membrane expands instantaneously to generate high-frequency ultrasound (>30MHz). The echo causes deformation of the FP cavity, and the A-mode ultrasound signal is reconstructed by detecting the wavelength drift of the reflected light.

[0051] Perform ablation function: i.e. photothermal ablation. The energy generation module of the control module switches to a high-power laser source (such as Ho:YAG or excimer laser band), and the optical fiber directly outputs laser energy to the tissue in front, vaporizing / ablating the plaque tissue.

[0052] The guidewire in this application is shown in Figure 2. Figure 2A illustrates the overall structure of the guidewire. The front end of the guidewire body 1 integrates a forward energy conversion component 2, namely an ultrasonic transmitting and receiving module. To reduce manufacturing difficulty and guidewire cost, a preferred single-beam ultrasonic generator is used to complete the detection of type A ultrasound signals and the transmission of penetrating ultrasound. The interior of the guidewire body 1 is used for delivery. The guidewire body 1 contains a signal piercing cable for the transmission of electrical and / or optical signals. The guidewire has an outer coating to increase tissue compatibility. To increase the guidewire's delivery performance and torsional control, the guidewire can employ a reinforced structure or commonly used guidewire braiding techniques, such as... Figure 2B The display shows that the energy conversion component 2 can be located at the center of the guidewire, or it can be set off-center as needed.

[0053] One embodiment of this guidewire is Figure 3 This demonstration demonstrates a guidewire used for vascular puncture. Placed inside the puncture needle, the guidewire generates forward ultrasound to detect the acoustic signature of the tissue. If a characteristic "peak-valley-peak" structure is detected, the vascular structure is considered to be within the needle's path, and the needle can continue along the current path. Otherwise, the path needs adjustment. When the "peak-valley-peak" acoustic signature changes to "valley-peak," combined with blood return, it can be determined that the needle tip is within the blood vessel, and the guidewire can be advanced. If the "peak-valley-peak" acoustic signature disappears during puncture, it indicates transmural damage or loss of the vascular structure, requiring readjustment. This puncture method increases the safety of the procedure.

[0054] One embodiment of this guidewire is as follows: Figure 4 The demonstration is used for pericardiocentesis; the heart is indicated by a fluctuating acoustic signature at the tip of the guidewire. The fluctuation of the acoustic signature is consistent with the electrocardiogram, which can be used to determine whether the puncture needle is in contact with the heart and to determine the safe distance.

[0055] Another embodiment of this guidewire is Figure 5 Demonstration for atrial septal puncture: The location of the atrial septal puncture is crucial for interventional procedures. A thicker atrial septum presents voiceprint information like A, while the foramen ovale presents voiceprint information like B. This helps determine whether the puncture site is located in the thinner foramen ovale. It also shows the distance between the puncture needle and the atrial wall, increasing the accuracy and safety of the puncture.

[0056] Another embodiment of this guidewire is Figure 6 The demonstration showed that during the process of opening blocked blood vessels, the guidewire can determine the nature of the plaque ahead, thereby increasing the accuracy of the opening process, and high-energy ultrasound can be used when necessary, thereby increasing the opening efficiency and safety.

[0057] The various embodiments described in this specification are presented in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. The above description of the disclosed embodiments enables those skilled in the art to implement or use this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A puncture guidewire with forward-looking detection and penetration functions, characterized in that, include: The guidewire body has a head end and a tail end, and an internal energy transmission channel. The outer diameter of the guidewire body is D, where 0.010in≤D≤0.038in. An energy conversion component is installed at the head end of the guidewire body; The end of the guidewire body receives photoelectric signals, which are transmitted to the energy conversion component via the energy transmission channel; at the same time, it can receive photoelectric signals returned by the energy component for tissue acoustic text analysis and display. The energy conversion component converts the received photoelectric signal into a single sound beam and emits it in the direction of travel of the guidewire body.

2. The puncture guidewire with forward detection and penetration function according to claim 1, characterized in that: The tail end of the guidewire body receives an electrical signal; The energy conversion component is a miniature piezoelectric transducer; The energy transmission channel is a micro coaxial cable or a flexible circuit board; The end of the guidewire body receives an electrical pulse, and the energy conversion component converts the electrical pulse into a type A ultrasonic pulse with a frequency of 10MHz to 60MHz. The tail end of the guidewire body receives pulses, and the energy conversion component converts the pulses into electrical pulses for signal analysis and display.

3. The puncture guidewire with forward detection and penetration function according to claim 1, characterized in that: The tail end of the guidewire body receives optical signals; The energy conversion component includes a photoacoustic generating layer and an optical interference sensing unit; The energy transmission channel is an optical fiber. The end of the guidewire body receives a nanosecond pulse laser, the photoacoustic generating layer expands to generate high-frequency ultrasound greater than 30MHz, and the optical interference sensing unit receives the echo. The tail end of the guidewire body receives a high-power laser source, and the optical fiber outputs laser energy to the front end of the guidewire body.

4. The puncture guidewire with forward detection and penetration function according to claim 1, characterized in that: The guidewire body is coated with a coating that increases tissue compatibility.

5. A puncture guidewire with forward detection and penetration function according to claim 4, characterized in that: The guidewire body adopts a reinforced structure.

6. The puncture guidewire with forward detection and penetration function according to claim 1, characterized in that: The energy conversion component is located at the center of the guidewire body, or the energy conversion component is offset from the center of the guidewire body.

7. The puncture guidewire with forward detection and penetration function according to claim 1, characterized in that: The tip of the guidewire body is flexible or pre-plastic.

8. An intelligent intervention system, characterized in that, include: The puncture guidewire, control module, and display with forward detection and penetration function as described in any one of claims 1-7, wherein the control module includes an energy generation module and a signal receiving and conversion module; The energy generation module emits photoelectric signals to the tail end of the guidewire body; The signal receiving and conversion module receives the echo signal of a single sound beam emitted by the energy conversion component, analyzes and converts it, and outputs the analyzed and converted signal to the outside. The display shows the information output by the signal receiving and conversion module and enables human-computer interaction.

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