A Visual Navigation Coronary Angiography Guidewire Assembly and Its Usage

Abstract

This application relates to the field of medical device technology and discloses a visual navigation coronary angiography guidewire assembly and its usage method. The main body of the assembly has a maximum outer diameter of no more than 0.36 mm and includes a guidewire body and a visual navigation unit integrated within it. The guidewire body consists of a proximal high-rigidity section and a distal flexible transition section. The core wire accommodates signal transmission lines through surface axial grooves or an internal hollow tube structure. A miniature sensor is fixed to the guidewire tip and communicates with an external processing terminal through a detachable proximal connection interface for real-time reconstruction of the tip's three-dimensional coordinates and orientation. This invention solves the problem of traditional X-ray fluoroscopy lacking depth information, achieving the integration of mechanical guidance and multimodal navigation. It ensures that the guidewire retains the axial support required to pass through stenotic lesions while possessing intravascular navigation capabilities, avoiding the problems of guidewire thickening or decreased mechanical maneuverability caused by integrated sensors.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a visual navigation coronary angiography guidewire assembly and its usage method. Background Technology

[0002] Percutaneous coronary intervention (PCI) has become the mainstream treatment for coronary artery disease, with the guidewire being the most basic and core instrument in the procedure. In standard interventional procedures, operators typically rely on two-dimensional X-ray fluoroscopy to observe the guidewire's path within the vessel. However, this traditional imaging method projects the three-dimensional vascular structure as a two-dimensional planar image, lacking depth information. While operators can build spatial awareness through multi-angle projection when dealing with routine lesions, in cases of chronic total occlusion (CTO) or severe diffuse calcification, the complete occlusion prevents contrast agent filling, and X-ray images only show the proximal and distal stumps of the vessel, leaving the occluded segment itself in a blind spot. In such cases, operators must rely on anatomical knowledge and the feel of the guidewire for blind probing. This lack of real-time positional feedback and depth information easily leads to the guidewire deviating from the true lumen centerline, mistakenly entering the subendothelial space to form a false lumen, or even puncturing the vessel wall, causing perforation or cardiac tamponade. This is the main reason for the high failure rate of CTO procedures.

[0003] To overcome the aforementioned predicament of "blind men feeling an elephant," existing intravascular ultrasound (IVUS) or optical coherence tomography (OCT) technologies, while capable of providing high-resolution images of the vascular lumen, typically have imaging catheters with outer diameters much larger than 0.014 inches (approximately 0.36 millimeters). These catheters cannot be used as the primary instrument to penetrate hard, narrow occluded segments and require guidance from a pre-guided guidewire to reach the correct position. Consequently, they cannot provide real-time navigation for the guidewire's puncture path.

[0004] Currently, while there are attempts in the industry to integrate miniature sensors onto guidewires for positioning, a severe size-performance paradox exists in practical applications. The outer diameter of standard guidewires for coronary intervention is strictly limited to within 0.014 inches to accommodate microcatheters and stent systems. Within such a small space, directly attaching sensors and signal transmission lines often results in the guidewire's outer diameter exceeding the limit, making it unable to pass through stenotic lesions; or, to accommodate the lines, the corewire's structural integrity must be sacrificed, leading to a decrease in axial support and torsional control, making the guidewire soft, brittle, and unable to penetrate hard fibrous caps or calcified plaques.

[0005] Furthermore, existing guidewire designs are not specifically optimized for electromagnetic or optical signal transmission. For example, the stainless steel helical spring coil sheath widely used in traditional guidewires is a ferromagnetic material, which can cause signal shielding or eddy current interference to integrated electromagnetic sensors, leading to drift in positioning accuracy. For optical sensors, the lack of a light-transmitting channel directly blocks signal transmission and reception. Simultaneously, existing wired guidewires typically use a fixed connection tail wire, making it impossible to change balloons or stents along the guidewire during surgery. This disrupts standardized interventional procedures and limits the widespread clinical application of this technology.

[0006] Therefore, there is an urgent need for a visual navigation guidewire system that can maintain the small size and excellent mechanical control performance of standard coronary guidewires, provide high-precision three-dimensional navigation information, and be compatible with existing surgical instrument exchange procedures. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a visual navigation coronary angiography guidewire assembly and its usage method. It solves the problem of how to achieve compatibility between mechanical control performance and three-dimensional visual navigation function under the limitation of the small size of standard coronary guidewires, thereby overcoming the difficulty in identifying the true lumen of complex lesions (especially chronic total occlusion lesions) due to the lack of depth information in single X-ray fluoroscopy during existing interventional procedures.

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] The first aspect of this invention provides a visual navigation coronary angiography guidewire assembly.

[0010] To achieve integrated navigation functionality while maintaining the mechanical properties of the guidewire within a standard outer diameter limit of 0.36 mm (0.014 inches), this invention employs an integrated structure. The main body of the component consists of the guidewire body, which integrates a visual navigation unit.

[0011] Regarding the mechanical transmission structure of the guidewire body, this invention resolves the contradiction between proximal advancement and distal compliance through a segmented design. The proximal advancement section of the core core wire is made of a high-rigidity material (such as stainless steel) to provide axial support and torque transmission within the guiding catheter; the distal tapered transition section achieves a smooth transition in stiffness through a gradient decrease in diameter (such as linear, parabolic, or step-like decrease), and is combined with a high-elasticity material (such as nickel-titanium alloy) at the end to give the guidewire breakage resistance and shape memory capability in tortuous blood vessels.

[0012] Regarding the miniaturized integration of the visual navigation unit, this invention establishes a signal path through structural modification of the core wire. A miniature sensor is fixedly mounted at the guidewire tip for acquiring position or image signals. To lay the signal transmission lines connecting the sensors without increasing the guidewire's outer diameter, the core wire features a dedicated channel structure. In one embodiment, axial grooves are created on the wire surface to accommodate the lines, which are then encapsulated and fixed using external heat-shrink tubing or a sheath. In another embodiment, a hollow tubular core wire is used, utilizing its hollow interior as the line channel. This embedded design ensures that the signal lines do not interfere with the contact interface between the guidewire and the blood vessel wall.

[0013] Regarding the functional integration design of the head end, this invention provides adaptive sensor installation schemes according to different tactile feedback requirements. In the molded strip connection structure, the sensors are attached side by side to the side of the metal molded strip connecting the core wire and the top end, preserving the malleable characteristics of the molded strip; in the core wire direct structure, the sensors are embedded in the groove at the end of the core wire, maintaining the direct mechanical transmission from the core wire to the head end.

[0014] Regarding signal compatibility and anti-interference design, the sheath material of this invention is matched to the sensor type. For optical navigation, the sheath layer uses a semi-transparent polymer or a segmented windowed helical spring coil to form an optical path channel; for electromagnetic navigation, the sheath layer uses a polymer or non-magnetic metal material to eliminate the interference of the metal shielding effect on the electromagnetic field. Furthermore, a detachable connection interface is provided at the proximal end of the guidewire, which allows for disconnection and reconnection from the signal line during surgery, thereby supporting the exchange of subsequent instruments such as balloons or stents along the guidewire.

[0015] A second aspect of the present invention provides a method for using a visual navigation coronary angiography guidewire assembly.

[0016] This method aims to utilize the structural characteristics of the aforementioned components to establish an intervention process that integrates mechanical control with visual feedback.

[0017] First, during the system initialization phase, a signal connection is established between the guidewire and the external processing terminal, and sensor calibration is completed. At the same time, the hydrophilic coating on the guidewire surface is activated by immersion in physiological saline to give it lubricating properties.

[0018] Secondly, during the vascular access establishment phase, the physical support of the proximal push segment of the guidewire is used to deliver the guidewire to the coronary artery ostium. This process is compatible with routine interventional procedures.

[0019] Furthermore, during the multimodal navigation phase, visual feedback is used to assist in vessel selection. Once the guidewire enters the coronary artery, the operator observes the X-ray fluoroscopic images while referring to navigation information displayed on an external processing terminal. The external processing terminal reconstructs the three-dimensional spatial coordinates and attitude angles of the guidewire tip by processing the microsensor signals and presents its real-time trajectory. Based on this trajectory information, the operator precisely controls the direction of the guidewire tip by rotating the core mandrel, thereby identifying and entering the target vessel branch in areas of overlapping or blurred X-ray images.

[0020] Finally, during the lesion passage phase, positional feedback is used to confirm the true lumen of the vessel. Especially when dealing with chronic total occlusion lesions, the operator combines tactile feedback from the hand with the relative position information of the guidewire tip displayed on the navigation system to monitor in real time whether the tip deviates from the vessel's centerline. If the navigation information shows the tip approaching the vessel wall boundary, indicating a risk of entering the subintimal region, the operator stops advancing and adjusts the angle accordingly, ensuring the guidewire always travels within the true lumen of the vessel and traverses the lesion area.

[0021] This invention provides a visual navigation coronary angiography guidewire assembly and its usage method. It has the following beneficial effects:

[0022] 1. This invention incorporates axial grooves on the surface of the core wire or uses a hollow tubular core wire structure to accommodate the signal transmission line, and uses external encapsulation for fixation. This allows the component to integrate a miniature sensor and transmission line while strictly controlling the maximum outer diameter within the standard coronary guidewire specification of 0.36 mm (0.014 inches). The composite mechanical structure of the proximal stainless steel high rigidity of the core wire and the distal nickel-titanium alloy tapered transition ensures that the guidewire retains the axial support force, torque transmission capacity, and fracture resistance required for passing through stenotic lesions while possessing intravascular navigation capabilities. This avoids the problem of guidewire thickening or decreased mechanical maneuverability caused by integrated sensors.

[0023] 2. This invention can superimpose real-time three-dimensional position and orientation information of the guidewire tip on the basis of traditional X-ray fluoroscopy. When dealing with chronic total occlusion (CTO) or severe calcified lesions, this multimodal navigation mechanism enables the operator to determine in real time whether the guidewire is located on the true lumen centerline of the blood vessel based on the relative position of the tip direction and the vascular anatomy. This effectively avoids the risk of subintimal dissection or vascular perforation in occluded segments that cannot be visualized by contrast agents, making up for the technical deficiency of single X-ray fluoroscopy in providing depth information.

[0024] 3. This invention matches specific sheath layer structures and materials to the physical characteristics of the sensor. For optical navigation, a semi-transparent polymer or segmented windowed spring coil is used to establish a transmission channel for the optical signal. For electromagnetic navigation, a non-magnetic metal material or polymer sheath is used to eliminate the shielding effect and eddy current interference of traditional stainless steel spring coils on electromagnetic fields. Combined with a proximal detachable connection interface design, this component not only ensures high-fidelity signal transmission but also allows for intraoperative disconnection from the signal line for standardized instrument exchange, resolving the incompatibility issue between wired guidewires and existing interventional treatment procedures. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0026] Figure 2 This is a schematic diagram of the internal structure of the present invention;

[0027] Figure 3 This is a schematic diagram of the core wire of the present invention;

[0028] Figure 4 This is a cross-sectional view of the metal helical spring coil of the present invention;

[0029] Figure 5 This is a block diagram of the navigation signal processing logic of the present invention;

[0030] Figure 6 This is a flowchart illustrating the clinical use of the present invention.

[0031] Among them, 30 is the near-end connection interface; 11 is the core wire; 12 is the sheath layer; 111 is the near-end push section; 112 is the far-end tapered transition section; and 130 is the top round cap. Detailed Implementation

[0032] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] See attached document Figure 1 - Appendix Figure 6 This invention provides a visual navigation coronary angiography guidewire assembly and an external processing terminal. The visual navigation coronary angiography guidewire assembly establishes a signal connection with the external processing terminal via a proximal connection interface 30, and is used to provide mechanical guidance and intravascular three-dimensional navigation information during coronary interventional procedures.

[0034] The visual navigation coronary angiography guidewire assembly integrates mechanical conduction and electronic navigation structures, and its maximum outer diameter is strictly limited to 0.36 mm (0.014 inches) to accommodate the lumen size of standard coronary interventional devices. The visual navigation coronary angiography guidewire assembly mainly consists of the guidewire body, a visual navigation unit integrated within the guidewire body, and a proximal connection interface 30 located near the handle.

[0035] The guidewire body is the mechanical basis of the assembly, responsible for transmitting pushing force, rotational torque and support force within the blood vessel. The guidewire body includes a core wire 11 extending axially, a sheath layer 12 covering the distal end of the core wire 11, and a functional coating on the surface of the core wire 11 and the sheath layer 12.

[0036] The core wire 11 forms the skeleton of the guidewire, and is divided axially into a proximal pushing section 111 and a distal tapered transition section 112 according to the mechanical performance distribution requirements. The diameter of the proximal pushing section 111 is between 0.05 inches and 0.014 inches, and it is made of high-modulus stainless steel to provide axial support stiffness and torque transmission efficiency for the guidewire.

[0037] The distal tapered transition section 112 is located distal to the proximal push section 111, and its diameter gradually decreases in the direction away from the proximal push section 111 until the distal end of the guidewire. The distal tapered transition section 112 is made of nickel-titanium alloy or has a nickel-titanium alloy segment connected to its end, utilizing the superelasticity of this material to give the distal end of the guidewire compliance and breakage resistance. The diameter change of the distal tapered transition section 112 is not a single form, but is configured according to a specific embodiment as a linear decrease, a parabolic decrease, or a step-like decrease in geometry, thereby forming a predetermined stiffness gradient at the distal end of the guidewire.

[0038] The visualization navigation unit is responsible for acquiring spatial location or image signals within the blood vessel. The visualization navigation unit includes miniature sensors and signal transmission lines. The miniature sensors are fixedly mounted at the foremost cap of the guidewire body.

[0039] The signal transmission line extends along the entire axial length of the core wire 11. Its distal end is physically connected to the micro-sensor to establish an electrical or optical signal path, and its proximal end extends to the end of the guidewire assembly and connects to the proximal connection interface 30. The signal transmission line is encapsulated or embedded in the internal structure of the guidewire body, without increasing the external profile size of the guidewire assembly.

[0040] The proximal connection interface 30 is configured as a detachable physical connector for signal coupling between the signal transmission line and the external processing terminal. This interface supports disconnection during surgery to facilitate coaxial exchange of the balloon catheter or stent system along the guidewire body, and supports reconnection after instrument exchange to restore navigation functionality.

[0041] The external processing terminal includes a signal demodulation module, a data processing host, and a display. The signal demodulation module receives the raw signal from the near-end connection interface 30 and converts it into a digital signal. The data processing host performs algorithmic processing on the digital signal to reconstruct the three-dimensional spatial coordinates and attitude angles of the miniature sensor. The display shows the real-time motion trajectory and relative position information of the guidewire tip.

[0042] See attached document Figure 1 - Appendix Figure 4 In this first embodiment, the core wire 11 adopts a solid composite material structure, which aims to solve the technical problem of simultaneously accommodating signal transmission lines and maintaining mechanical conductivity under the constraint of an outer diameter of 0.36 mm (0.014 inches).

[0043] The core wire 11 is axially composed of a proximal pushing section 111 and a distal tapered transition section 112. The proximal pushing section 111 is made of 304V or 316L high-strength stainless steel wire, hardened by a cold drawing process to obtain a high Young's modulus, ensuring the axial thrust transmission efficiency of the guide wire during long-distance transport. The distal tapered transition section 112 is made of a super-elastic nickel-titanium alloy. The proximal pushing section 111 and the distal tapered transition section 112 are connected to form a connection area 1 by high-energy beam welding (such as laser welding) or sleeve crimping.

[0044] The distal tapered transition section 112 is machined using a centerless grinding process, and its diameter does not decrease uniformly along the axial direction. Depending on the specific clinical application, the distal tapered transition section 112 can be configured in one of two ways:

[0045] A linearly decreasing structure, where the diameter decreases linearly with the length, provides uniformly varying bending stiffness and is suitable for common lesions.

[0046] The parabolic decreasing structure, in which the diameter decreases as the length follows a parabolic function, retains a thicker diameter in the stress concentration area and tapers rapidly at the distal end, thereby maximizing the flexibility at the distal end while ensuring support, making it suitable for tortuous blood vessels.

[0047] To facilitate the laying of signal transmission lines, the surface of the core wire 11 is provided with axially extending grooves. These axial grooves are formed on the outer circumferential surface of the core wire 11 through laser etching or precision mechanical grooving. The depth of the axial grooves is less than 50% of the radius of the core wire 11 to avoid significantly weakening the tensile strength and torsional resistance of the wire. The width of the axial grooves matches the outer diameter of the signal transmission line, typically controlled between 0.05 mm and 0.15 mm.

[0048] The signal transmission line is embedded inside the axial groove. A very thin polymer encapsulation layer covers the outside of the signal transmission line. This polymer encapsulation layer uses polyethylene terephthalate (PET) heat shrink tubing or a polyimide coating, tightly wrapping around the outer surface of the core wire 11. The function of the polymer encapsulation layer is twofold: first, to physically fix the signal transmission line within the axial groove, preventing it from coming out when the guide wire bends or rotates; second, to fill the surface discontinuities caused by the axial groove, restoring the smooth circular cross-section of the core wire 11, thus facilitating the subsequent sheath layer 12.

[0049] See attached document Figure 1 - Appendix Figure 4 In this second embodiment, in order to further protect the signal transmission line from external mechanical stress, the proximal push section 111 of the core core wire 11 adopts a hollow tubular structure (i.e., a hypotube).

[0050] The hollow tubular structure is made of stainless steel tubing with an outer diameter matching the proximal diameter of a standard guidewire, and has a continuous hollow inner cavity. The wall thickness of the hollow tubular structure is controlled within the range of 0.03 mm to 0.08 mm to maximize the cross-sectional area of ​​the hollow inner cavity while providing sufficient wall stiffness.

[0051] At the distal end of the hollow tubular structure, a helical cut is formed by laser cutting or a plug-in transition piece, connecting to a solid distal tapered transition section 112. The signal transmission line passes through the hollow cavity and extends to the guidewire tip at the distal end via a transition connection area. In this embodiment, because the signal transmission line is located near the neutral axis, the tensile or compressive stress on the line is minimized when the guidewire bends, thereby reducing the risk of fatigue fracture.

[0052] In the two embodiments described above, the specific form of the signal transmission line is matched according to the type of the micro sensor. When the micro sensor is a magnetic sensor, the signal transmission line is a micro coaxial cable or twisted pair, with an external metal shielding layer to isolate electromagnetic interference; when the micro sensor is an optical sensor, the signal transmission line is a single-mode fiber or multi-mode fiber, which includes a core, cladding, and coating layer, and the fiber transmits optical signals within the allowable bending radius of the core filament 11.

[0053] At the very end of the distal tapered transition section 112, the core wire 11 is ground into a flat strip or an extremely fine round wire to serve as the connection basis for the head end forming.

[0054] See attached document Figure 1 - Appendix Figure 4This section elaborates on the integration method of the distal end of the guidewire and the specific implementation structure of the sensor packaging of the present invention. This part aims to disclose the mechanical fixing method of the micro-sensor at the tip of the ultra-fine guidewire, and how to solve the problems of navigation signal shielding and attenuation through the structural configuration of the external sheath.

[0055] See attached document Figure 1 - Appendix Figure 4 In this third embodiment, in order to retain the malleable characteristics of the guidewire tip, that is, to allow the operator to manually bend the guidewire tip into a J shape or a specific angle according to the vascular anatomy, a design that separates the core wire from the shaping band is adopted.

[0056] The distal tapered transition section 112 of the core wire 11 terminates at a predetermined distance (typically millimeters to 30 millimeters) from the distal end cap 130. At this termination location, a metal forming strip with a rectangular cross-section is welded. The metal forming strip extends axially and connects to the cap 130. The metal forming strip is made of stainless steel or nickel-titanium alloy and has low bending stiffness in the thickness direction to support the forming operation.

[0057] The microsensors (in this embodiment, manifested as micro-electromagnetic coils or fiber optic probes) are not coaxially arranged, but rather attached side-by-side to the side of the metal forming strip. Medical-grade epoxy resin or UV-curable adhesive fills the space between the microsensors and the metal forming strip, forming a stable parallel composite bundle. This side-by-side arrangement ensures that when the surgeon bends and shapes the tip, the primary deformation occurs on the metal forming strip, while the microsensors undergo elastic displacement without destructive shear stress, thus guaranteeing the physical integrity of the sensors.

[0058] To prevent fatigue fracture at the connection point between the signal transmission line and the microsensor due to an excessively small bending radius when the guidewire bends within tortuous blood vessels, a stress-relieving structure is incorporated in the connection area. Specifically, within a 1-3 mm region proximal to the welding or coupling point between the signal transmission line and the microsensor, the signal transmission line is provided with a slightly redundant length in an S-shape or spiral configuration. This redundant section is encapsulated in a low-hardness silicone or soft polyurethane potting compound with a Shore A hardness of 30-50. When the guidewire tip bends, the soft potting compound undergoes elastic deformation, allowing the reserved redundant line to release tension. This transforms the rigid shear stress at the connection point into elastic deformation of the line itself, ensuring the mechanical stability of the electrical or optical connection.

[0059] The top cap 130 is made of a high-density radiopaque metal material (such as platinum-iridium alloy or gold) and has a smooth hemispherical surface. It is used to mark the distal position of the guidewire under X-ray fluoroscopy and to prevent the guidewire tip from puncturing the blood vessel wall.

[0060] See attached document Figure 1 - Appendix Figure 4 In this fourth embodiment, in order to provide higher cephalic tactile feedback sensitivity and penetration for chronic total occlusion (CTO) lesions, the core filament 11 extends directly through to the farthest end.

[0061] The distal tapered transition section 112 of the core wire 11 extends and is directly welded or bonded to the inner surface of the top cap 130. At the very end region of the core wire 11 (typically the last 5 mm to 1 mm), a portion of the material is removed using a microfabrication process to form a sensor receiving groove. The sensor receiving groove is an open groove or a coaxial blind hole formed on the side of the wire end.

[0062] The miniature sensor is embedded within the sensor housing and is integrated with the core wire using an encapsulating colloid. This structure achieves rigid coupling between the miniature sensor and the core wire 11. When the guidewire tip contacts a calcified lesion or fibrous cap, the contact resistance is directly transmitted to the proximal end through the rigid core wire 11 at a 1:1 ratio, allowing the operator to obtain clear tactile feedback. Simultaneously, because the sensor is located at the center of the end of the mechanical transmission path, its positional accuracy more accurately represents the true coordinates of the guidewire puncture point.

[0063] Based on the above embodiments three and four, the guide wire tip is covered with a sheath layer 12, and the material and structure of the sheath layer 12 are specifically configured according to the signal type of the micro sensor.

[0064] When the microsensor is an optical sensor (such as an optical frequency domain reflectance OFDR probe or an optical coherence tomography OCT probe), the sheath layer 12 is configured as a light-transmitting structure.

[0065] In one configuration, the sheath layer 12 is made of an optically transparent or translucent thermoplastic polyurethane or polyether block amide material with a transmittance of more than 85% in the operating wavelength range to allow light beams to exit and receive reflected light from the blood vessel wall.

[0066] In another configuration, if the sheath layer 12 includes a coil to increase visibility, the metal coil structure adopts a segmented window design, that is, at the axial position corresponding to the sensor, the winding pitch of the coil is increased to more than twice the wire diameter to form a physical gap as a light window, while in other areas it remains tightly wound to maintain flexibility.

[0067] When the miniature sensor is an electromagnetic sensor (such as a miniature induction coil), the sheath layer 12 is configured with a low electromagnetic interference structure. If the sheath layer 12 is made of a polymer material, it naturally possesses electromagnetic wave penetration capability. If the sheath layer 12 adopts a metal helical spring coil structure to provide tactile feedback, the metal helical spring coil is made of a non-ferromagnetic metal material, specifically selected from platinum-tungsten alloy, platinum-iridium alloy, or pure gold. By avoiding the use of traditional magnetic materials such as stainless steel or cobalt-chromium alloy, the eddy current effect generated by the metal closed-loop structure in an alternating magnetic field and the shielding attenuation of the magnetic field signal are eliminated, ensuring that the miniature sensor can receive an undistorted magnetic field positioning signal.

[0068] See attached document Figure 1 - Appendix Figure 4 This section provides a detailed description of the proximal connection interface structure and functional coating of the guidewire assembly of the present invention. This part aims to fully disclose how mechanical structure design achieves compatibility between instrument exchange and signal transmission during interventional surgery, and how surface treatment processes optimize guidewire delivery performance.

[0069] See attached document Figure 6 , Figure 6 This is a schematic diagram of the proximal connection interface structure and connection according to Embodiment 5 of the present invention. In this embodiment, the proximal connection interface 30 is configured as a detachable signal coupling device, which aims to solve the problem that traditional fixed connection lines hinder the insertion of subsequent balloon catheters or stent catheters when the guidewire is used as a monorail or coaxial instrument delivery track.

[0070] The end of the proximal push section 111 of the core wire 11 (i.e., the physical end of the guide wire assembly) is provided with a signal contact area. When the visualization navigation unit operates based on electrical signals (such as electromagnetic navigation), the signal contact area consists of several annular conductive strips arranged axially. These annular conductive strips are electrically connected to the core wire and shielding layer of the signal transmission line (miniature coaxial cable) embedded inside the guide wire. The annular conductive strips are isolated from each other by an insulating material, and their outer surfaces are ground to ensure that their outer diameter is consistent with the nominal diameter of the core wire 11 (i.e., not exceeding 0.014 inches), ensuring a smooth surface without protrusions.

[0071] In a preferred embodiment, for the near-end connection interface 30 for optical signal transmission, a floating ceramic ferrule structure is employed to ensure low-loss coupling of the single-mode fiber with a core diameter of only a few micrometers after multiple insertions and removals. The near-end signal contact area of ​​the core fiber 11 is precision machined and glued into a zirconia ceramic ferrule with a diameter of 1.25 mm or 2.5 mm. The fiber end face and the ferrule end face are jointly ground into a physical contact (PC) or beveled physical contact (APC) geometry.

[0072] The near-end connection interface 30 is equipped with a corresponding elastic open sleeve. When the guide wire is inserted into the interface, the ceramic ferrule is automatically aligned axially under the elastic clamping of the open sleeve, ensuring that the axial deviation between the fiber core in the core wire and the fiber core of the transmission fiber inside the interface is less than 1 micrometer, thereby controlling the insertion loss to below 0.5 dB.

[0073] When the visual navigation unit operates based on optical signals (such as optical navigation), the signal contact area is manifested as the optically polished surface of the end face of the core wire 11. The end face of the signal transmission line (optical fiber) is exposed here and is precision polished to form an optical coupling plane.

[0074] The proximal interface 30 includes a locking mechanism and a signal conversion module. The locking mechanism employs a collet-type or screw-on mechanical structure. During use, the operator inserts the proximal end of the core guidewire 11 into the central hole of the locking mechanism. After the locking mechanism tightens, it not only mechanically clamps the guidewire to prevent it from falling out, but also drives the internal probe (for electrical signals) or optical sleeve (for optical signals) to make precise physical contact or alignment with the signal contact area. The signal conversion module converts the acquired raw signal into a standard transmission protocol signal and connects it to an external processing terminal via a flexible cable.

[0075] In clinical procedures, when it is necessary to exchange therapeutic devices along the guidewire, the operator releases the locking mechanism and completely removes the proximal connection interface 30 from the proximal end of the guidewire. At this time, the proximal end of the guidewire returns to its standard smooth rod-like structure, allowing the central lumen of the balloon catheter or stent system to be inserted from the proximal end of the guidewire and slide distally along the guidewire. After the therapeutic device is positioned, the operator can re-attach the proximal connection interface 30 to the proximal end of the guidewire and lock it, restoring navigation signal transmission, thus enabling device exchange without removing the guidewire.

[0076] See attached document Figure 1 - Appendix Figure 4 In this embodiment, in order to balance the guidewire's passability within the blood vessel with the operator's control feel, the outer surface of the guidewire body exhibits a differentiated coating distribution along the axial direction.

[0077] The proximal delivery section 111 of the core wire 11 (typically occupying the proximal portion of the guidewire from one to 150 cm in total length) is covered with a hydrophobic coating. This hydrophobic coating is made of polytetrafluoroethylene (PTFE) and is cured onto the surface of the stainless steel core wire using electrostatic spraying or heat-shrink coating processes. The PTFE coating has extremely low surface energy and a low coefficient of friction, which reduces dry friction between the guidewire and the inner wall of the guiding catheter or microcatheter, improving guidewire delivery efficiency and rotational response, providing good tactile feedback, and preventing guidewire sticking during long-distance delivery.

[0078] The distal region of the guidewire (typically encompassing the distal tapered transition section 112 and the tip, with a length of approximately 30 to 40 centimeters) is covered with a hydrophilic coating. This hydrophilic coating is made of a hydrophilic polymer material based on polyvinylpyrrolidone (PVP) or polyacrylamide. This hydrophilic coating is chemically bonded to the outer surface of the sheath layer 12 (such as a polymer sheath or metal spring coil) via ultraviolet (UV) curing or thermosetting processes.

[0079] In a dry state, the hydrophilic coating is in a hardened state; upon contact with aqueous media such as saline or blood, the hydrophilic coating rapidly absorbs moisture and forms a hydrogel film with a thickness of micrometers on its surface. This hydrogel film reduces the coefficient of friction of the distal guidewire surface to below 0.02, greatly improving the guidewire's sliding ability in narrowed, calcified, or highly tortuous coronary arteries and reducing the risk of mechanical damage to the vascular intima.

[0080] The hydrophobic coating and the hydrophilic coating are overlapped or gradient transitioned at the interface to ensure that there is no step difference on the surface and to prevent jamming during instrument delivery.

[0081] See attached document Figure 5 This section elaborates on the working principle of the visualization navigation unit and the signal processing logic of the external processing terminal in this invention. This part aims to fully disclose, from the perspective of physical principles and data flow, how the system transforms the raw signals from the micro-sensors into clinically visualized three-dimensional spatial information.

[0082] The external processing terminal receives the raw physical signals from the guidewire assembly via a signal demodulation module, converts them into spatial coordinates via a geometric calculation algorithm unit within the data processing host, and finally renders them on the display by the rendering engine. Depending on the type of micro-sensor, this invention incorporates two specific navigation implementation principles.

[0083] First implementation method: Navigation principle based on electromagnetic induction:

[0084] When the miniature sensor is a miniature induction coil, the system is equipped with a magnetic field generator placed outside the patient's body. The magnetic field generator produces an alternating magnetic field with a known intensity gradient and directional distribution within a specific spatial region centered on the patient's heart.

[0085] The miniature sensor, acting as the receiver, enters the magnetic field region along with the guide wire. According to Faraday's law of electromagnetic induction, the induced electromotive force (EMF) generated at the ends of the miniature sensor coil is proportional to the rate of change of magnetic flux through the coil's cross-section. Since the vector characteristics of the magnetic field generated by the magnetic field generator at different spatial positions and directions are predefined and unique, the signal demodulation module can reverse-engineer the six-degree-of-freedom (6-DOF) data of the coil center in the magnetic field coordinate system—namely, the three-dimensional position coordinates and three-dimensional attitude angles—by measuring the amplitude and phase of the induced voltage output by the miniature sensor.

[0086] The geometric solution algorithm unit executes a coordinate system registration procedure, mapping the data in the magnetic field coordinate system to the image coordinate system of the X-ray angiography machine. Based on the mapped coordinate data, the rendering engine overlays a virtual projection of the guidewire tip onto the two-dimensional X-ray fluoroscopic image, or constructs a three-dimensional pointing arrow of the guidewire tip relative to a pre-stored vascular model in a separate window, thereby showing the operator the real-time directional nature of the guidewire tip.

[0087] The second implementation method: Navigation based on optical shape perception principle:

[0088] When the micro-sensor and signal transmission line are fiber optic grating (FBG) arrays or Rayleigh scattering-based optical fibers, the system uses the wavelength drift or backscattering characteristics of light waves to sense the shape.

[0089] The external processing terminal's light source emits laser light of a specific wavelength into the signal transmission line. When the guidewire bends or twists within the blood vessel, the optical fiber embedded in the core filament 11 undergoes elastic deformation, causing microscopic changes in the fiber's internal lattice structure or refractive index. If fiber grating technology is used, the grating period at a specific location in the fiber is stretched or compressed due to strain, causing a shift in the center wavelength of the reflected light. If optical frequency domain reflection technology is used, the inherent Rayleigh scattering pattern within the optical fiber will undergo spectral shift due to axial strain.

[0090] The signal demodulation module captures the aforementioned spectral changes in real time using an interferometer and converts the wavelength shift into strain values ​​at discrete points along the fiber optic axis. The geometric calculation algorithm unit employs a continuum mechanics integral algorithm to calculate the local curvature and twist of the fiber along its path based on the strain data at each point, and reconstructs the overall three-dimensional shape curve of the guidewire from the proximal end to the distal end through curve integration.

[0091] In this mode, the system can not only acquire the position and orientation of the most distal tip, but also reconstruct the entire morphology of the guidewire within the blood vessel in real time. The rendering engine fuses this 3D morphological model with the angiographic image for display, helping the operator determine whether the guidewire is kinked at a bend in the blood vessel or whether it follows the anatomical course of the blood vessel.

[0092] Furthermore, considering the temperature difference between the intravascular environment (approximately 37°C) and the operating room environment (approximately -25°C), and the temperature sensitivity of the output characteristics of miniature sensors (especially fiber optic sensors), the data processing host also executes a temperature drift compensation algorithm. During system initialization, the sensor's spectral or impedance characteristics at the reference temperature are recorded. After the guidewire enters the blood vessel, the system utilizes the sensor's own cross-sensitivity to temperature, or a miniature thermistor integrated next to the miniature sensor, to acquire the head-end ambient temperature data in real time. The geometric calculation algorithm unit, based on a pre-set model of the material's thermal expansion coefficient and thermo-optic coefficient, subtracts the wavelength drift or impedance change caused by temperature variations from the original signal, retaining only the signal component caused by mechanical deformation, thereby eliminating coordinate calculation errors caused by thermal effects.

[0093] Data processing and real-time feedback process:

[0094] Whether using electromagnetic or optical navigation, the system follows a unified data processing closed loop:

[0095] Signal acquisition: The sensor continuously outputs raw analog signals or optical signals at a high sampling rate.

[0096] Demodulation and digitization: The signal demodulation module filters out environmental noise (such as electromagnetic noise generated by X-ray machines), extracts effective feature values, and converts them into digital sequences.

[0097] Geometric calculation: The data processing host combines the mechanical parameters of the guidewire (such as length and sensor installation offset) and applies kinematic equations to calculate the current state vector of the tip.

[0098] True lumen discrimination logic: For CTO lesions, the algorithm unit compares the trajectory of the cephalic end with a pre-constructed vessel centerline model. If the cephalic end coordinates are detected to continuously deviate from the centerline and approach the vessel wall boundary (defined by the angiographic contour), or if abnormal obstruction of cephalic end movement is detected (inferred by the rate of position change combined with tactile feedback), the system will issue a visual warning to the operator on the display through a color change (e.g., from green to red), indicating the risk of subintimal intrusion.

[0099] See attached document Figure 6 This paper details the specific application process and typical case operation strategies of the visual navigation coronary angiography guidewire assembly of the present invention in clinical interventional surgery. This section aims to fully disclose the step details in the method claims, particularly the operational logic for identifying the true lumen in chronic total occlusion (CTO) lesions using navigation information.

[0100] The clinical usage process mainly includes five core stages: system initialization, vascular access establishment, multimodal navigation and shape selection, lesion passage and true lumen confirmation, and device exchange.

[0101] Step S100: System Initialization and Preparation

[0102] On the sterile operating table, the surgeon first removes the guidewire assembly. The proximal connection interface 30 is then inserted into the slot of the external processing terminal to establish a physical and signal connection. The external processing terminal automatically runs a self-test program to verify the signal integrity of the miniature sensor and performs zero-point calibration based on the current ambient magnetic field or optical path state.

[0103] Subsequently, the operator flushes the guidewire protective coil with a syringe filled with heparinized saline, or directly immerses the guidewire in the saline basin. This step aims to activate the hydrophilic coating covering the surface of the sheath layer 12, causing it to absorb moisture and transform into a gel-like lubricating state, thereby reducing the surface friction coefficient of the distal end of the guidewire to the working range (typically <0.02), preparing it for entry into the blood vessel.

[0104] Step S200: Establishment of vascular access

[0105] The operator establishes a channel in the radial or femoral artery using a puncture needle, inserts a guiding catheter, and advances it to the coronary artery ostium. Subsequently, the operator advances the visualization-guided coronary angiography guidewire assembly into the guiding catheter via a hemostatic valve. At this stage, the operator primarily holds the proximal pusher segment 111 of the core core wire 11. Because the proximal pusher segment 111 is made of high-rigidity stainless steel and coated with a hydrophobic polytetrafluoroethylene coating, it provides sufficient axial support, allowing the guidewire to overcome frictional resistance within the guiding catheter and advance smoothly until the guidewire tip extends beyond the guiding catheter and is visible under X-ray fluoroscopy.

[0106] Step S300: Multimodal navigation and vessel branch selection

[0107] Once the guidewire enters the main coronary artery, the operator activates multimodal navigation mode. At this time, the catheterization lab monitor simultaneously displays real-time X-ray fluoroscopic images (2D planar view) and a navigation view (3D spatial view) generated by an external processing terminal. When facing a vascular bifurcation, X-ray images often show overlapping or shortened vessels due to the projection angle, making it difficult to distinguish the spatial relationship between the vessels. In this case, the operator observes the navigation view, which displays the real-time three-dimensional pointing vector of the guidewire tip. By twisting the proximal end of the core mandrel 11 with their fingers, the operator utilizes the torque transmission capability from the proximal push segment 111 to the distal tapered transition segment 112 to precisely control the rotation angle of the tip. The navigation view provides real-time feedback on the tip's rotational attitude (Roll) and yaw angle. Based on this three-dimensional pointing information, the operator adjusts the guidewire tip to align with the spatial orientation of the target vascular branch and then pushes it forward into the target branch.

[0108] Step S400: Lesion confirmed by comparison with the true lumen (Example for CTO lesions)

[0109] This step is the key operation in solving the core technical problem of this invention. When treating chronic total occlusion (CTO) lesions, the occluded segment of the vessel cannot be visualized with contrast agent. Traditional methods rely solely on blind probing by feel, which easily leads to the guidewire drilling into the subendothelial space, creating a false lumen. When using this invention, the operator follows this logic:

[0110] Trajectory monitoring: The operator slowly pushes the guidewire into the occluded fibrous cap. An external processing terminal records the trajectory of the guidewire tip and compares it with a pre-imported vascular anatomy model (based on CT angiography reconstruction) or a predicted vascular centerline path.

[0111] Tactile and visual fusion judgment: The operator senses changes in resistance at the tip of the core guidewire 11 (tactile feedback). If a high-resistance calcification point is encountered, and the navigation shows that the tip is located in the central area of ​​the vessel cross-section, it indicates that the guidewire is pressing against a hard plaque, and the operator can increase the thrust or perform a drilling operation.

[0112] Deviation Warning and Correction: If the navigation information shows that the coordinates of the guidewire tip are gradually deviating from the vessel centerline and approaching the vessel wall boundary (intima / media), the external processing terminal will issue a visual warning (e.g., the trajectory line turns red). This indicates that the guidewire is at risk of slipping into the subintima. Upon receiving this information, the operator immediately stops pushing forward, retracts the guidewire a few millimeters, and significantly rotates the core wire 11 to change the tip orientation until the navigation shows the tip pointing back to the center axis of the vessel's true lumen, before continuing the attempt. Through this closed-loop feedback, the guidewire is ensured to always travel within the true lumen until it penetrates the lesion and reaches the distal vessel.

[0113] Step S500: Instrument exchange

[0114] After the guidewire successfully passes through the lesion and reaches the distal anchoring position, if a balloon catheter or stent needs to be advanced along the guidewire, the operator releases the locking mechanism of the proximal connection interface 30 and removes it from the proximal end of the guidewire. At this point, the proximal end of the guidewire returns to a standard bare wire state. The operator then uses a standard monorail or coaxial procedure to place the treatment device onto the guidewire and advance it into position. After the treatment device is removed, if it is necessary to reconfirm the vascular condition or perform subsequent navigation, the operator reconnects the proximal connection interface 30 to the proximal end of the guidewire, and the system automatically resumes signal transmission and navigation display.

Claims

1. A visual navigation coronary angiography guidewire assembly, characterized in that, include: The guidewire body includes a core wire (11) extending along the axial direction, a sheath layer (12) covering the distal end of the core wire (11), and a hydrophilic coating on the distal surface of the core wire (11). The core core wire (11) includes a proximal push section (111) and a distal tapered transition section (112), the diameter of which gradually decreases in the direction away from the proximal push section (111); A visual navigation unit, comprising a miniature sensor, a signal transmission line, and a near-end connection interface (30). The miniature sensor is fixedly mounted on the head end of the guidewire body; The signal transmission line extends along the axial direction of the core filament (11), the distal end of the signal transmission line is electrically connected to the micro sensor or optical signal connected, and the proximal end of the signal transmission line is connected to the proximal connection interface (30). The visualization navigation unit is integrated into the guidewire body, and the maximum outer diameter of the guidewire assembly does not exceed 0.014 inches.

2. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The core wire (11) adopts a segmented composite structure, and the core wire (11) specifically includes: The proximal push section (111) is made of stainless steel and is used to provide axial support force; The end of the distal tapered transition section (112) is made of nickel-titanium alloy material or is connected to a nickel-titanium alloy section; The diameter reduction method of the distal tapered transition section (112) is selected from one of the following: linear decreasing structure, parabolic decreasing structure or stepped decreasing structure.

3. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The core wire (11) is provided with a channel structure for accommodating the signal transmission line, and the channel structure is one of the following structures: An axial groove is formed on the surface of the core wire (11), the signal transmission line is embedded in the axial groove, and fixed by an external polymer heat shrink tubing or the sheath layer (12); The core wire (11) has a hollow inner cavity that runs through it. The core wire (11) is a hollow tubular structure, and the signal transmission line passes through the hollow inner cavity.

4. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The tip structure of the guidewire body is selected from any of the following: Molded strip connection structure: The end of the core wire (11) is connected to the top round cap (130) through a rectangular cross-section metal molded strip, and the micro sensors are attached side by side to the side of the metal molded strip; Core wire direct structure: The end of the core wire (11) extends directly and is connected to the top round cap (130), and the micro sensor is embedded in the groove at the end of the core wire (11).

5. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The sheath layer (12) is configured according to the signal type of the visual navigation unit as follows: When the micro-sensor is an optical sensor, the sheath layer (12) is a semi-transparent polymer sheath, or a spiral spring coil with a segmented window structure, allowing light signals to pass through; When the micro-sensor is an electromagnetic sensor, the sheath layer (12) is a polymer sheath or a spiral spring coil made of non-magnetic metal material to avoid shielding electromagnetic signals.

6. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The proximal connection interface (30) is a detachable connector. The proximal connection interface (30) is used to disconnect from the proximal end of the signal transmission line when the guidewire assembly needs to be replaced with subsequent treatment devices, and supports reconnection after the treatment device is removed.

7. The visual navigation coronary angiography guidewire assembly according to claim 1, characterized in that, The surface of the proximal push section (111) of the core core wire (11) is covered with a polytetrafluoroethylene coating; The hydrophilic coating covers the outer surface of the sheath layer (12), and the hydrophilic coating forms a gel-like lubricating surface in a hydrated state.

8. A method of using a visual navigation coronary angiography guidewire assembly, characterized in that, The application of a visualization-guided coronary angiography guidewire assembly as described in any one of claims 1-7 includes the following steps: System initialization: Connect the proximal connection interface (30) to the external processing terminal, calibrate the micro sensor, and activate the hydrophilic coating by immersing it in physiological saline. Vascular access establishment: The guidewire assembly is delivered to the coronary artery ostium via a guiding catheter, and the guidewire position is maintained by the support force of the proximal push segment (111); Multimodal navigation: After the guidewire enters the coronary artery, the direction of the tip of the guidewire body is controlled by rotating the core core wire (11) and the target blood vessel branch is selected, based on the X-ray fluoroscopic image and the navigation information displayed by the external processing terminal. Lesion passage: Based on the navigation information, determine the position of the tip of the guidewire body relative to the true lumen of the blood vessel, and pass through the stenotic or occluded lesion area.

9. The method of using a visual navigation coronary angiography guidewire assembly according to claim 8, characterized in that, In the multimodal navigation step, the external processing terminal reconstructs the three-dimensional spatial coordinates and attitude angle of the guidewire tip by solving the signals of the micro-sensors, and presents the real-time motion trajectory of the guidewire tip on the display interface to assist the operator in identifying the direction of blood vessels in the overlapping area of ​​X-ray images.

10. A method of using a visual navigation coronary angiography guidewire assembly according to claim 8, characterized in that, The lesion is specifically addressed through the following steps: When treating chronic total occlusion lesions, the guidewire body tip is monitored in real time to see if it deviates from the center line of the blood vessel by combining hand tactile feedback with the navigation information. If the navigation information indicates that the tip is close to the boundary of the blood vessel wall, stop pushing and adjust the angle to keep the tip moving within the true lumen of the blood vessel.

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