Systems and methods for optimized medical component insertion monitoring and imaging enhancement

Abstract

According to one embodiment, a guidance system for assisting advancement of a medical component within a patient is described. The guidance system features a probe and a console. The console is communicably coupled to the probe and features an AI-based visualization control and an AI-based guidance assistance logic. The AI-based visualization control is configured to generate, position, and reposition a visualization region between the medical component and a target vasculature of the patient. The visualization region is a sub-region of a total imaging region presented by the console. The AI-based guidance assistance logic is configured to monitor a presence of the medical component within the visualization region, provide feedback for generating a notification of the medical component within the visualization region, and impose an imaging enhancement on at least a portion of imaging data within the visualization region to assist advancement.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 061,120, filed August 4, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to systems and methods for optimized medical component insertion monitoring and imaging enhancement. Background Technology

[0004] In the past, clinicians relied on various guiding systems, such as ultrasound systems, to assist in inserting needles into a patient's vascular system (e.g., blood vessels, arteries, etc.). However, without substantial expertise, clinicians could not easily detect the presence of a needle in the image displayed on the ultrasound monitor. The lack of real-time detection of needle location was problematic because it might require the clinician to suddenly move the needle within the subcutaneous tissue to penetrate the target vascular system. As a result, the patient might experience unnecessary pain during the procedure, and the success rate of needle insertion into the target vascular system (hereinafter referred to as the "needle insertion success rate") might be lower than expected.

[0005] Traditional needle insertion guidance systems rely on sensor arrays configured to sense detectable characteristics associated with the needle, such as the magnetic field of the magnetic elements included in the needle. In this example, sensors are arranged within the ultrasound probe to continuously detect the magnetic field induced by the magnetic elements, allowing circuitry within the guidance system to calculate the needle's position and orientation during its advancement. However, for inexperienced clinicians relying solely on captured ultrasound images, the actual needle location may differ from its position as presented on the guidance system's monitor. This display delay can lead to a reduced needle insertion success rate.

[0006] Furthermore, artificial intelligence (AI) programs based on machine learning or neural network techniques are already being used to analyze images. However, the operational complexity of AI programs is somewhat correlated with the size of the images being analyzed, and the complexity of analyzing certain images presented on the ultrasound system monitor can lead to delays in generating these images. This delay in presenting images on the ultrasound system monitor (waiting time) also provides clinicians with inaccurate information about the current orientation and positioning of the needle.

[0007] Therefore, guidance enhancements with low latency are needed to improve the operability of ultrasound or other guidance systems. Summary of the Invention

[0008] In brief, the embodiments disclosed herein relate to a guidance system for medical components, such as needles. One embodiment of the guidance system is configured to monitor the advancement of a medical component (e.g., needle, guide, catheter, etc.) via acoustic (ultrasound) and / or magnetic fields according to a medical component tracking subsystem. The medical component tracking subsystem may include, but is not limited to, ultrasound-based or magneto-based tracking systems (e.g., sensor arrays with console I / O components as described below), tip positioning subsystems (TLS), or any other tracking subsystem (e.g., via permanent magnets (multiple permanent magnets)) at the distal end of the medical component during its advancement through a vascular system, as described in U.S. Patent No. 9,456,766, the contents of which are incorporated herein by reference. The guidance system is also configured with sensor analysis logic to generate visual, audio, or tactile feedback in response to detection that the medical component is entering / leaving a target vascular system (e.g., vein, artery, etc.).

[0009] Another implementation of the guidance system features an artificial intelligence (AI)-based visualization control and AI-based guidance assistance logic. The AI-based visualization control is configured to generate and position a visualization area—a designated portion of the total imaging area presented by the guidance system—based on the orientation and advancement of the medical component. In other words, before the medical component contacts the outer wall surface of the target vascular system, the visualization area is positioned (and repositioned if necessary) by the AI-based visualization control to intercept the medical component, as the positioning of the medical component is known via the medical component tracking subsystem.

[0010] The AI-based guidance and assistance logic is configured to communicate with the medical component tracking subsystem to monitor entry into or exit from the visualization area, thereby notifying the clinician that the medical component is approaching a target vascular system and generating image enhancement of the medical component or a portion of the visualization area. The clinician's notification can be accomplished by transmitting signaling to an audio, visual, or tactile (e.g., haptic) feedback from a monitor, audio device (e.g., a speaker), or probe, which generates visual, auditory, and tactile notifications.

[0011] According to one embodiment, a guidance system characterized by a probe and a console is described. The console is communicatively coupled to the probe. The console includes sensor analysis logic that (i) monitors the presence of a medical component within a visualization area and near a target destination, the visualization area being a subset of the total imaging area presented by the guidance system, and (ii) provides feedback to the device for generating notification of the presence of a medical component within the visualization area. According to one embodiment, the guidance system monitors the guidance system for a medical component (e.g., a needle), detecting needle reflections from the guidance system when the probe is operating as part of an ultrasound system. The needle feedback is based on a magnetic field detected by the probe, and the needle reflection includes magnetic elements disposed within the medical component.

[0012] According to one embodiment of this application, the sensor analysis logic of the guidance system is configured to provide feedback that visually identifies the presence of a medical component within a visualized area. As an illustrative example, the sensor analysis logic can generate a signal to illuminate a light element within the probe, which identifies the medical component within a visualized area near a vascular system, the target destination. As another illustrative example, the sensor analysis logic can provide feedback to an audio device to generate an auditory notification to identify the presence of a medical component within a visualized area near a vascular system, the target destination. As yet another illustrative example, the sensor analysis logic is configured to provide feedback to a haptic feedback device disposed within the probe to generate a haptic notification as control of probe operation.

[0013] According to another embodiment of this application, the console further includes artificial intelligence (AI)-based visualization controls and AI-based guidance assistance logic. These AI-based visualization controls are configured to generate a visualization area. The AI-based guidance assistance logic is configured to (i) detect the presence of a medical component within the visualization area near the target destination, (ii) provide feedback to the device to generate a notification that a medical component is present within the visualization area, and (iii) generate and apply imaging enhancement to at least a portion of the imaging data within the visualization area to assist the medical component in advancing toward the target destination, which is a vascular system.

[0014] As an illustrative implementation, image enhancement may include color overlay of at least a portion of an image of the medical component (e.g., static color adjustment based on entry into the visualization area, dynamic color adjustment based on the position of the medical component (needle), etc.) or image overlay (e.g., increased contour thickness of the distal end or entire portion of the medical component (needle) within the visualization area, magnified display image of the medical component (needle) within the visualization area, etc.) to provide better clarity regarding the position of the medical component. According to another illustrative implementation, image enhancement includes a virtual representation of the medical component and vascular system within the visualization area. In addition to image enhancement, AI-based guidance assistance logic may be configured to generate notifications, including activating lights on the probe or a console light, to indicate whether the needle has entered or left its target destination.

[0015] These and other features of the embodiments of the invention will become clearer from the following description and appended claims, or may be learned through practice of the embodiments of the invention as set forth below. Attached Figure Description

[0016] A more specific description of this application will be presented with reference to the specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained in more specific and detailed manner using the drawings, wherein:

[0017] Figure 1 This is an exemplary implementation of a guidance system for monitoring the insertion of a needle or other medical component into a patient's body;

[0018] Figure 2 This is an exemplary block diagram depicting various elements of an ultrasound-based guidance system for needles and other medical components according to a first embodiment of the guidance system.

[0019] Figure 3 yes Figure 2 Top view of the ultrasonic probe of the guidance system;

[0020] Figure 4A It is based on one implementation method and Figure 2 A side view of the needle used in conjunction with the guide system;

[0021] Figure 4B yes Figure 4A A view of the end of the needle;

[0022] Figure 5A and Figure 5B It is a guide needle used to guide blood vessels into the patient's body. Figure 2 A simplified view of the ultrasound probe of the guidance system;

[0023] Figure 6A and Figure 6B A possible screenshot for depicting a boot system display according to one embodiment is shown, illustrating the position and orientation of the needle;

[0024] Figure 7 This is based on the second implementation of the boot system. Figure 1 An exemplary implementation of the architecture of an AI-based bootstrapping system;

[0025] Figures 8A to 8E It is by Figure 7 An exemplary implementation of a first embodiment of an AI-based guidance system that generates and monitors a visualization area for enhancing the display of a medical component (e.g., a needle) based on needle reflection and audio / visual / tactile notifications;

[0026] Figures 9A to 9B It is by Figure 7 An exemplary implementation of an operation method based on AI-guided and assisted logic. Detailed Implementation

[0027] Referring now to the accompanying drawings, in which the same structures have the same reference numerals. It should be understood that the drawings are illustrative and schematic representations of exemplary embodiments of the invention, and are neither limiting nor necessarily drawn to scale.

[0028] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are sometimes used to distinguish or identify different components or operations and do not provide for serial or numerical limitations. For example, the components or operations “first,” “second,” and “third” do not necessarily appear in sequence, and a particular embodiment that includes such components or operations is not limited to or restricted to these three components or operations. Similarly, labels such as “left,” “right,” “top,” “bottom,” “front,” and “rear” are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative positions, orientations, or directions. Unless the context clearly specifies otherwise, the singular forms “an,” “a,” and “the” include plural references.

[0029] In the following description, the terms “or” and “and / or” as used herein shall be interpreted as inclusive or referring to any one or any combination thereof. As an example, “A, B, or C” or “A, B, and / or C” means “any one of the following: A; B; B; A and B; A and C; B and C; A, B, and C”. Exceptions to the definition occur only when the combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0030] The term "logic" refers to hardware and / or software configured to perform one or more functions. As hardware, logic can include circuitry with data processing and / or storage capabilities. Examples of such circuitry include, but are not limited to, processors, programmable gate arrays, microcontrollers, application-specific integrated circuits (ASICs), combinational circuits, etc. Alternatively, or in combination with the aforementioned hardware circuitry, logic can be software in the form of one or more software modules that can be configured to operate as their corresponding circuitry. Software modules can include, for example, executable applications, daemon applications, application programming interfaces (APIs), subroutines, functions, procedures, routines, source code, or even one or more instructions. Software modules (multiple software modules) can be stored in any suitable type of non-transient storage medium, such as programmable circuitry, semiconductor memory, non-persistent storage devices such as volatile memory (e.g., any type of random access memory "RAM"), persistent storage devices such as non-volatile memory (e.g., read-only memory "ROM", power-backup RAM, flash memory, phase-change memory, etc.), solid-state drives, hard disk drives, optical disk drives, or portable storage devices.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0032] General Boot System Architecture

[0033] refer to Figure 1 An illustrative embodiment of the guiding system 100 is shown, wherein a needle or other medical component 110 can be positioned and guided to enter the subcutaneous vascular system 120 of a patient 130 during an ultrasound procedure, a magnetic field imaging procedure, or other suitable guiding procedure. According to this embodiment of the application, the guiding system 100 can be configured to operate as an ultrasound imaging system, but the guiding system 100 can be arranged according to a technology type other than ultrasound.

[0034] like Figure 1 As shown, the guidance system 100 is characterized by a console 140, a monitor 150, and a probe 160. The console 140 may be configured with a sensor array within the probe 160 (see [link to documentation]). Figures 2 to 3 The sensor analysis logic (SAL) 170 operates collaboratively. The sensor array can capture the position and / or orientation of the medical component 110 via sound waves (ultrasound), wherein the medical component 110 may include, for example, a needle, catheter, or guide. In the following text, for simplicity, the medical component 110 may generally be referred to as "needle" 110.

[0035] Alternatively, in an alternative to console 140, monitor 150, and probe 160, a tip positioning subsystem "TLS" (not shown, see [link]) can be deployed. Figure 2 The position and / or orientation of the needle 110 can be determined in real time through magnetic field analysis. As another implementation, in addition to or replacing sensor analysis logic 170 and / or TLS, the console 140 may be configured with artificial intelligence (AI) to control the operability of the guidance system 100, namely, an AI-based visualization control (AVC) 180 and an AI-based guidance assistance logic (AGAL) 190 to present imaging enhancements that help guide the clinician during needle 110 advancement, as described below.

[0036] like Figure 1As shown, for example, a guidance system 100 operating as an ultrasound imaging system is configured to generate images of a target internal portion of the patient's body immediately before and after the insertion of a needle 110 via the skin. In one embodiment, such as guided needle advancement, the guidance system 100 can be used to image the area surrounding the vascular system 120 during and / or after the needle 110 is inserted via the skin to enter the target vascular system 120. As described below, the insertion of the needle 110 can be performed before the catheter is inserted into a portion of the vascular system 120 of the patient 130. However, it will be understood that the insertion of the needle 110 into the patient 130 can be used for a variety of medical purposes.

[0037] According to one embodiment of this application, sensor analysis logic 170 receives orientation measurements from a sensor array and, in response to needle 110 entering a region of interest (ROI) defined by the vascular system 120 itself, sensor analysis logic 170 is configured to generate a notification regarding entry into the vascular system. More specifically, sensor analysis logic 170 is configured to monitor state changes of needle 110 (inside the vascular system versus outside the vascular system). In response to a state change, sensor analysis logic 170 may be configured to generate a signaling that causes monitor 150 to present a visual notification of the state change, for displaying or activating lights on probe 160 or console 140 to indicate whether the needle has entered or left the vascular system 120. Alternatively or additionally, sensor analysis logic 170 may be configured to generate a signaling that causes an audio device (e.g., speaker 155) to emit an auditory notification in response to any state change, such as a first type of auditory notification (e.g., a buzzer, tone, etc.) in response to a transition from an outside-vascular state to an inside-vascular state, and a second type of auditory notification in response to a transition from an inside-vascular state to an outside-vascular state.

[0038] In addition to visual or audio notifications, and again, in addition to or in lieu of visual and / or audio notifications, sensor analysis logic 170 may be configured to generate signaling that will cause a tactile feedback device within probe 160 to provide a physical warning (e.g., vibration and / or another force-based feedback) as a tactile notification. (Described below and...) Figure 3 The haptic feedback device is shown in the image.

[0039] According to another embodiment of this application, operating separately from or in conjunction with the sensor analysis logic 170, an AI-based visualization control 180 is configured to receive orientation measurements of the needle 110 from the probe 160 and generate and position a visualization region 195 based on these orientation measurements. As shown, the visualization region 195 corresponds to a portion of the total imaging region 192 presented by the guidance system 100. In this embodiment, the visualization region 195 is substantially smaller in size than the total imaging region 192 (e.g., less than 1 / 10 of its size), which may include an image captured by a sound beam 162 emitted from the probe 160 and presented on a monitor 150 of the guidance system 100 for display. The size of the visualization region 195 may be static or dynamic (e.g., based on needle specifications, medical component type, etc.). Furthermore, the position of the visualization region 195 may be changed based on the position, orientation, and advance of the needle 110 to intercept the advance of the needle 110 before contacting the outer wall surface of the target vascular system 120.

[0040] Specifically, the guidance system 100 allows the position, orientation, and advancement of the medical component 110 (e.g., a needle) to be superimposed in real time onto the ultrasound image of the vascular system 120, thereby enabling clinicians to accurately guide the needle 110 into the vascular system 120, as in... Figures 8A-8E As shown in more detail below. Furthermore, for some implementations, imaging enhancements can be applied to a portion of the imaging data, such as static or dynamic color overlays based on the presence and / or location of medical components within the visualization area, in terms of color variation. Alternatively or in an alternative, imaging enhancements may include an image overlay of at least a portion of the image of the needle 110 (e.g., a thicker outline, a magnified size of certain portions of the needle (e.g., the portion of the needle within the visualization area)) to provide better clarity regarding its location. Another imaging enhancement may include generating a virtual representation of the visualization area (using the needle 110 and the vascular system 120). Other imaging enhancements may be used, wherein these enhancements are designed to assist clinicians during the advancement of the needle 110.

[0041] Furthermore, for this implementation, the guidance system 100 is based on, as follows: Figure 1 The dashed lines in the diagram indicate multiple degrees of freedom of motion during propulsion to track the position of the needle 110. The position of the needle 110, from at least insertion of the needle 110 to subsequent upward or downward angular adjustment of the needle 110, can be represented by the following information: xyz coordinate space, pitch of the needle 110, and / or yaw (e.g., orientation) of the needle 110. Here, for some embodiments, the information can constitute an orientation metric provided to the AI-based visualization control 180. In other embodiments, the orientation metric can be based at least in part on this information or a portion thereof.

[0042] This tracking allows for the guidance and placement of the distal end (tip) 112 of the needle 110 with relatively high accuracy, regardless of the movement of the needle 110. Furthermore, based on information collected during the tracking operation (e.g., needle reflection), the position of the needle 110 can be determined, wherein the AI-based visualization control 180 is configured to generate and reposition the visualization area 195 to capture the distal end 112 of the needle 110 moving toward the vascular system 120.

[0043] According to one embodiment of this application, AI-based guidance assistance logic 190 can be configured to monitor the position of needle 110 as it enters or leaves visualization area 195. As shown, visualization area 190 can be represented as a “bounding box,” i.e., an area of ​​any shape whose calculated path along the advancement of needle 110 is located near and may include vascular system 120. Upon entering visualization area 195, AI-based guidance assistance logic 190 notifies the clinician that needle 110 is approaching the target vascular system. Notification can be accomplished by providing visual, auditory, and / or tactile (e.g., haptic) feedback signaling to sensors within monitor 150, audio device 155, and / or probe 160.

[0044] Additionally, upon entering the visualization area 195, AI-based guidance assistance logic 190 generates further imaging enhancements to aid in the visualization of the needle 110's close proximity to the vascular system 120. One type of imaging enhancement may include color and / or image overlay of the needle 110 (as described above) to provide better clarity regarding its location. Another type of imaging enhancement may include activating a light source (e.g., a light-emitting diode) accompanying the needle 110, mounted on the probe 160 or the console 140. Yet another type of imaging enhancement may include generating a secondary (virtual) image with appropriate magnification to provide a split-screen view of the needle 110 close to and engaged with the vascular system 120.

[0045] As described above, placement of a medical component (e.g., a needle) 110 into the patient's vascular system 120 at an insertion site 125 can be performed out of plane, with the needle 110 entering the skin remotely from the probe 160 and aligned with the plane of the ultrasound beam 162 emitted from the probe 160. Using this method, only the distal end 112 of the needle 110 is visualized, and the remainder of the needle 110 can be removed from the screen during detection.

[0046] Enhanced guidance system with sensor-based feedback

[0047] The embodiments of the invention described herein generally relate to a guidance system 100 for locating and guiding medical components (e.g., needles) during ultrasound-based procedures or other suitable procedures involving access to a patient's subcutaneous vascular system. In one embodiment, the guidance system 100 tracks the position of the needle with five degrees of freedom: x, y, and z spatial coordinates, pitch, and yaw (e.g., orientation). Such tracking enables the guidance and placement of the needle with relatively high precision.

[0048] like Figure 2 The diagram illustrates the various components of an ultrasound-based guidance system 100 configured according to one embodiment of the present invention. As shown, the guidance system 100 typically includes a console 140, a monitor 150, a TLS sensor 290, and a probe 160, each of which is described in further detail below. Here, the console 140 may include a housing 200 to protect the various components of the system 100 from environmental conditions and may be adapted in various forms. For example, a processor including a memory such as non-volatile memory (e.g., electrically erasable programmable read-only memory (flash memory), battery-backed random access memory, etc.) 205 is included in the console 140 to control the functions of the guidance system 110, thus acting as a control processor. A digital controller / analog interface 210 is also included within the console 140 and communicates with certain system components that interface with the processor 205 and the control probe 160 and other system components.

[0049] The boot system 100 also includes a port 215 for connecting to additional components, such as optional components 217 including a printer, storage medium, keyboard, etc. According to one embodiment of the invention, port 215 may include a Universal Serial Bus (USB) port, but other port types or combinations of port types may be used for this and other interface connections described herein. The console 140 includes a power connection 220 for operable connection to an external power supply 222. An internal power supply (e.g., a battery) 224 may also be used, with or without the external power supply 222. Power management logic 230 is included within the digital controller / analog interface 210 of the console 140 to regulate power usage and distribution.

[0050] According to one embodiment of this application, the monitor 150 can be integrated into the console 140 and can be used to display information to the clinician during placement, such as ultrasound images of the patient's region of interest captured by the probe 160. However, in another embodiment, the monitor 150 can be separate from the console 140. In the embodiments of this application, the monitor 150 is a liquid crystal display (LCD) device.

[0051] In one embodiment, probe 160 includes console interface logic 240 and / or probe interface logic 250, which can be used to enable a clinician to select a desired mode for monitor 150 to assist the needle placement process. Signaling from probe 160 is transmitted to console 140 via probe interface logic 250. Probe interface 250 includes piezoelectric input / output (I / O) components 260 and control I / O components 265. Piezoelectric I / O component 260 interfaces with a sensor (piezoelectric) array 270 that captures images via acoustic waves, including needle reflections that identify the position, orientation, and movement of needle 110 during the ultrasound imaging process. Control I / O component 265 interfaces with control buttons and a memory controller 275 to receive operating commands from them.

[0052] The guidance system 100 employs a TLS sensor 290 to detect magnetic fields generated by the magnetic elements of the medical component (e.g., needle 110 or a core needle within needle 110). During needle insertion, the TLS sensor 290 can be positioned near the patient's region of interest. During needle advancement, the TLS sensor 290 detects the magnetic field associated with the magnetic element, which provides the clinician with information about the position and orientation of the medical component (needle) 110 during its advancement.

[0053] The TLS sensor 290 is operatively connected to the console 140 of the boot system 100 via one or more ports 215. During a mode (TLS mode) set by the probe 160, the magnetic element within the needle 110 detected by the TLS sensor 290 is graphically displayed on the monitor 150 of the console 140. This allows the clinician controlling the boot system 100 to activate the TLS sensor 290 or establish communication between the TLS sensor 290 and the monitor 150.

[0054] Now for reference Figure 3 , showed Figures 1 to 2 An exemplary implementation of probe 160. Probe 160 is used in conjunction with ultrasound-based visualization of a vascular system, such as a vein, to prepare for the insertion of a medical component 110 (e.g., a needle, catheter, etc.) into the vascular system. This visualization provides real-time ultrasound guidance and helps reduce complications typically associated with this introduction of the needle 110, including unintentional arterial puncture, etc.

[0055] Specifically, according to one embodiment of this application, the probe 160 includes a housing 300 characterized by an interface 310 having externally accessible control buttons 315, allowing clinicians to control the operability of the guidance system 100 without reaching the outside of a sterile area. As shown, the housing 300 encapsulates a sensor array 270 (including a piezoelectric array 340 and / or a magnetic field sensor 350), a controller 360, and a tactile feedback device 380. However, it is conceivable that the sensor array 270 could be positioned outside the housing 300 and attached to the probe 160.

[0056] As shown in the figure, the piezoelectric array 340 is located near the head 320 of the housing 300. When the head 320 is positioned close to the intended insertion position 125 against the patient's skin, the piezoelectric array 340 can be configured to generate ultrasonic pulses and receive the echoes reflected from the patient's body. Figure 1 As shown.

[0057] For example Figure 3 As shown, including non-volatile memory such as flash memory, controller 360 manages button and probe operations. Controller 360 is operatively communicates with probe interface 250 of console 200, which includes piezoelectric I / O component 260 and control I / O component 265. Piezoelectric I / O component 260 is configured to interface with piezoelectric array 340 of sensor array 270, while control I / O component 265 is configured to interface with controller 360.

[0058] As in Figure 3 As also seen, sensor array 270 is configured to detect the position, orientation, and movement of needle 110 during ultrasound imaging processes such as those described above. As will be further described in detail below, sensor array 270 includes magnetic field sensors 350, namely a plurality of magnetic sensors 3501-350 embedded within the housing 300 of probe 160. N (N≥2). According to one embodiment of this application, these sensors 3501-350 N It is configured to detect the magnetic field associated with needle 110 and enable system 100 to track needle 110. Although configured here as a magnetic sensor, it should be understood that, as will be described, sensors 3501-350 N Other types and configurations of sensors are also possible. Additionally, sensor 3501-350... N It can be configured in a component separate from probe 160, such as a detachable handheld device. In this embodiment, sensor 3501-350 N It is positioned in a planar configuration below the top surface 370 of probe 160, but it is understandable that sensor 3501-350... N It can be arranged in other configurations, such as an arc or semi-circular arrangement.

[0059] In this embodiment, sensor 3501-350 N Each of these can correspond to, for example, a three-dimensional sensor with three orthogonal sensor coils, capable of detecting magnetic fields in three-dimensional space. Alternatively, sensor 3501-350... N It can be configured as a Hall effect sensor, but other types of magnetic sensors can be used. Alternatively, multiple one-dimensional magnetic sensors can be included and arranged as needed to achieve 1D, 2D, or 3D detection capabilities.

[0060] In embodiments of this application, five sensors 3501-3505 are included as part of a sensor array 270, so that the needle 110 can be detected not only in three-dimensional space (i.e., X, Y, Z coordinate space), but also in the pitch and yaw orientation of the needle 110 itself. Note that in one embodiment, two or more sensors 3501-350... N The orthogonal sensing components in the sensor array enable the determination of the pitch and yaw attitude of the medical component 110, and thus the pitch and yaw attitude of the needle 110. However, in other embodiments, fewer or more sensors may be used in the sensor array 270. More generally, it can be understood that sensors 3501-350... N The quantity, size, type, and arrangement may differ from those explicitly shown here.

[0061] The haptic feedback device 380 includes reference to one or more devices that, when activated, generate a tactile experience by applying force, vibration, or motion to a clinician operating the probe 160. According to one embodiment of this application, the haptic feedback device 380 may be configured to support haptic feedback corresponding to vibration and / or force feedback. The use of vibration may rely on actuators comprising an unbalanced weight impacting an axially rotatable shaft, such as an eccentric rotating mass (ERM) actuator. When the actuator is activated, the rotation of the irregular mass as the shaft rotates causes the actuator and the attached device to vibrate. Similarly, force feedback relies on an electric motor to manipulate the movement of an object held by a user to simulate forces applied to the object.

[0062] Figure 4A and Figure 4B Details of an example of a needle 110 according to one embodiment are shown. The needle 110 can be used in conjunction with a guiding system 100 to approach, for example... Figure 1The patient's target internal body portion is shown. Specifically, needle 110 includes a hollow cannula 400 defining a proximal end 405 and a distal end 410. In this embodiment, a needle bushing 415 is connected to the proximal end 405 of the cannula 400 and includes an open end 420 configured as a connector for connection to various devices. In effect, the open end 420 of the needle bushing 415 communicates with the hollow cannula 400, allowing guidewires, core needles, or other components to pass through the needle bushing 415 into the cannula 400.

[0063] like Figure 4A and Figure 4B As shown, the needle bushing 415 includes a magnetic element 450. (As in...) Figure 4B As detailed in the diagram, the magnetic element 450 in this embodiment is a permanent magnet, such as comprising a ferromagnetic material, and is annular to define an aperture 460 aligned with the hollow cannula 400. In this configuration, the magnetic element 450 generates a magnetic field detectable by the sensor array 270 (or possibly TLS 290) of the ultrasonic probe 160, enabling the system 100 to track the position, orientation, and movement of the needle 110, as further described below.

[0064] In other embodiments, it will be understood that the needle 110 or other medical components may employ many other types, numbers, and sizes of magnetic elements to enable tracking by this guidance system.

[0065] Now for reference Figure 5A and Figure 5B , Figure 5A and Figure 5B The ultrasound probe 160 and needle 110 of system 100 are shown in place and ready to be inserted through the patient's skin surface 500 to approach a target internal body part. Specifically, probe 160 is shown with its head 320 positioned against the patient's skin and generating an ultrasound beam 162 to perform ultrasound imaging of a portion of the vascular system 120 beneath the patient's skin surface 500. An ultrasound image of the vascular system 120 can be plotted on the monitor 150 of system 100. Figure 1 ).

[0066] As described above, the system 100 in this embodiment is configured to detect the position, orientation, and movement of the needle 110. Specifically, the sensor array 270 of the probe 160 is configured to detect the magnetic field of the magnetic element 450 included in the needle 110. The sensor array 270 includes sensors 3501-350. N Each of these is configured as a spatially detecting magnetic element 450 in three-dimensional space. Therefore, during operation of system 100, the sensors 3501-350... NThe magnetic field strength data of each sensed needle's magnetic element 450 is forwarded to a processor, such as console 140. Figure 1 The processor 205 calculates the position and / or orientation of the magnetic element 450 in real time.

[0067] Specifically, such as Figure 5A and Figure 5B As shown, system 100 can use sensors 3501-350. N The sensed magnetic field strength data determines the position of the magnetic element 450 relative to the sensor array 270 in the X, Y, and Z coordinate space. Additionally, Figure 5A The diagram shows that the pitch of the magnetic element 450 can also be determined, while Figure 5B The yaw of magnetic element 450 can be determined. Appropriate circuitry of the system's probe 160, console 140, or other components can provide the calculations required for this position / orientation. In one embodiment, the teachings of one or more of the following U.S. patents can be used to track magnetic element 450: 5,775,322; 5,879,297; 6,129,668; 6,216,028; and 6,263,230. The contents of the above U.S. patents are incorporated herein by reference in their entirety.

[0068] The position and orientation information determined by system 100, together with the length of sleeve 400 and the position of magnetic element 450 relative to the distal needle tip 112 (as known to the system or input into the system), enables the system to accurately determine the position and orientation of the entire length of needle 110 relative to sensor array 270. Optionally, the distance between magnetic element 450 and distal needle tip 112 is known to system 100 or input into system 100. This, in turn, enables system 100 to overlay the image of needle 110 onto the image generated by ultrasonic beam 162 of probe 160. Figure 6A and Figure 6B An example of this overlay of needle 110 on ultrasound image 600 is shown.

[0069] Here, Figure 6A and Figure 6B Each example can be shown in monitor 150 ( Figure 1 The screenshot above (in Chinese) is 600 pixels. Figure 6A The image shown is an ultrasound image 610, including a depiction of the patient's skin surface 620 and subcutaneous blood vessels 630. For example, ultrasound image 610 corresponds to a depiction of... Figure 5A and Figure 5B The image acquired by the ultrasonic beam 162 is shown.

[0070] Screenshot 600 also shows a needle image 640 representing the actual position and orientation of the needle 110 as determined by the guidance system 100 as described above. Because the system 100 is able to determine the position and orientation of the needle 110 relative to the sensor array 270, the guidance system 100 is able to accurately determine the position and orientation of the needle relative to the ultrasound image 610 and overlay it onto the ultrasound image 610 as the needle image 640 depicted on the monitor 150. The positioning of the needle image 640 on the ultrasound image 610 is coordinated by a suitable algorithm executed by the processor 205 or other suitable component of the guidance system 100.

[0071] Sensor 3501-350 N The system is configured to continuously detect the magnetic field of the magnetic element 450 of the needle 110 during operation of the guidance system 100. This allows the guidance system 100 to continuously update the position and orientation of the needle image 640 plotted on the monitor 150. Therefore, the advancement or other movement of the needle 110 is plotted in real time via the needle image 640 on the monitor 150. Note that the guidance system 100 is able to continuously update both the ultrasound image 610 and the needle image 640 on the monitor 150 when the probe 160 and the needle 110 are moved during placement or other activities.

[0072] Figure 6A Also shown in one embodiment, system 100 can depict a projection path 650, as depicted in needle image 640, based on the current position and orientation of needle 110. Projection path 650 assists clinicians in determining whether the current orientation of needle 110 (as depicted in needle image 640 on monitor 150) will lead to reaching a desired internal body part target, such as the vascular system 120 shown here. Similarly, system 100 modifies projection path 650 accordingly when the orientation and / or position of needle image 640 changes. Target 660 indicates the intended destination of the needle. Figure 6A As shown, in this example, target 660 is located within the vascular system 120 depicted in ultrasound image 610. Note that the position of target 660 on monitor 150 can also be modified when adjusting needle 110 and / or ultrasound image 610.

[0073] In one implementation method Figure 6BScreenshot 600 is shown to be configured such that ultrasound image 610 and needle image 640 are oriented for display in a three-dimensional orientation 670. This allows the angle and orientation of needle 110, as shown in needle image 640, to be determined and compared with the intended target imaged by ultrasound image 610. It should be noted that screenshot 600 is merely an example of a possible description generated by system 100 for display; in practice, other visual descriptions may be used. It should also be noted that the specific area of ​​the body being imaged is merely an example; the system can be used for ultrasound imaging of various body parts and should not be limited to what is explicitly depicted in the figures. Furthermore, the system as described herein may be included as a component of a larger system, or may be configured as a stand-alone device, as needed. In addition, it is understood that, in addition to providing visual information presented on monitor 150, system 100 may also employ auditory information, such as beeps, tones, etc., to assist clinicians during needle positioning and insertion into the patient.

[0074] As described above, in one embodiment, system 100 must know the total length of needle 110 and the position of magnetic element 450 thereon in order to accurately map... Figure 6A and Figure 6B The screenshot 600 shows the needle image 640 and other features. The system 100 can be informed of these and / or other relevant parameters in various ways, including by scanning a barcode included on or with the needle by the system, a radio frequency identification (“RFID”) chip included with the needle for scanning by the system, the needle’s color coding, or by the clinician manually entering the parameters into the system, etc.

[0075] In one implementation, measurement can be performed via probe / system 160 / 100. Figure 4A The characteristics of the magnetic element 450 (e.g., its field strength) determine the length of the needle 110 (or other aspects of the medical component). For example, in one embodiment, the magnetic element 450 of the needle 110 may be positioned at a predetermined distance from or relative to the probe 160. With the magnetic element 450 thus positioned, the sensor array 270 of the probe 160 detects and measures the field strength of the magnetic element 450. The system 100 may compare the measured field strength with a stored list of possible field strengths corresponding to different needle lengths. The system 100 may match these two strengths and determine the needle length. Needle positioning and subsequent needle insertion can then be performed as described herein. In another embodiment, instead of keeping the magnetic element 450 fixed in a predetermined position, the magnetic element 450 may be moved around the probe 160, allowing the probe 160 to obtain multiple field strength readings. Various aspects may be modified to assign different field strengths to a set of magnetic elements, including the size, shape, and composition of the magnetic elements.

[0076] Further details are given herein regarding the use of system 100 according to one embodiment in guiding a needle or other medical device to ultrasound image a target internal body part (“target”) of a patient. With the needle 110, equipped with a magnetic element, positioned at an appropriate distance (e.g., two feet or more) from an ultrasound probe 160 including a sensor array 270, the probe 160 is used to perform ultrasound imaging of the target within the patient's body, which the needle 110 intends to cross by insertion through the skin, for mapping onto the monitor 150 of system 100. System 100 calibration is then initiated, where an algorithm is executed by the processor 205 of console 140 to determine a baseline for any ambient magnetic field in the vicinity of the procedure. System 100 is also informed, for example, by user input, automatic detection, or other suitable means as described above, of the total length of the needle 110 and / or the position of the magnetic element relative to the distal needle tip 112.

[0077] Then the needle 110 is inserted into the sensor array 270 of the probe 160, specifically into the sensor 3501-350. N Within the range. Sensor 3501-350 N Each detection in the magnetic field strength associated with the magnetic element 450 of the needle 110 is forwarded to the processor 205. In one embodiment, such data can be stored in memory until needed by the processor 205. When sensors 3501-350... N When a magnetic field is detected, processor 205 executes a suitable algorithm to calculate the magnetic field strength of the magnetic element 450 of needle 110 relative to the probe at a predicted point in space. Then, processor 205 connects sensor 3501-350... N The detected actual magnetic field strength data is compared with the calculated magnetic field strength value. Note that the aforementioned US patent also describes this process. This process can be performed iteratively until the calculated value at the predicted point matches the measured data. Once this match occurs, the magnetic element 450 is positioned in three-dimensional space. This is achieved using sensors 3501-350. N The detected magnetic field strength data can also determine the pitch and yaw (i.e., orientation) of the magnetic element 450. Together with the known length of the needle 110 and the position of its distal tip 112 relative to the magnetic element 450, this allows the system 100 to determine an accurate representation of the needle's position and orientation and depict it as a virtual model, i.e., needle image 640. This representation can be provided as a basis for... Figure 2 Orientation measurement of sensor analysis logic 170 or AI-based visualization logic 180 as described in Figure 8 below.

[0078] In this embodiment, the needle image is superimposed on... Figure 1The virtual needle image 640 of the needle 110 is drawn on the ultrasound image 610 of the monitor 150 as described above. An appropriate algorithm of the system 100, executed by the processor 205 or other suitable component, also enables the projection path 650 and the target 660 to be determined and drawn on top of the ultrasound image 610 of the target 660 on the monitor 150. The above-described prediction, detection, comparison, and drawing process is repeatedly executed to continue tracking the movement of the needle 110 in real time.

[0079] Enhanced guidance system with AI-based feedback

[0080] Reference Figure 7 The diagram shows an AI-based visual control unit 180 and an AI-based boot assist logic 190 (hereinafter referred to as "AI-based boot system 700"). Figure 1 An exemplary implementation of the architecture of the boot system 100. Here, the AI-based boot system 700 is characterized by a console 140, a monitor 150, and a probe 160, such as Figures 1 to 3 As shown. More specifically, according to this embodiment, the console 140 is characterized by one or more sets of components within its housing 710, which may be oriented in various forms.

[0081] Similar to Figure 1 As shown and described above, the AI-based boot system 100 may include a first set of components, such as one or more ports 215, for connection to additional components, such as optional components 217 (e.g., printers, storage media, keyboards, etc.). According to one embodiment of this application, port 215 may include a USB port, but other port types or combinations of port types may be used. The console 140 includes a power connection 220 to enable operative connection to an external power supply 222. An internal power supply (e.g., a battery) 224 may also be used with or independently of the external power supply 222.

[0082] As a second set of components, the AI-based guidance system 700 may further include console interface logic 240 and / or probe interface logic 250, which may be included on the probe 160 and may be disposed within the console 140 itself. Console interface logic 240 allows clinicians to modify the operability of the console 140 via a physical interface. As described above, probe interface logic 250 allows clinicians to control the selection of a desired mode of the monitor 150 to assist the needle placement process. Signals from the probe 160 are transmitted to the console 140 via probe interface logic 250. Probe interface 250 includes piezoelectric I / O components 260 operating as an interface to sensor array 270 and control I / O components 265 operating as an interface to control buttons and a memory controller 275.

[0083] A third set of components within the console 140 may include a digital controller / analog interface 210, which communicates with both the processor 205 and the control probe 160, as well as other system components that interface with them. Figure 7 As shown, the digital controller / analog interface 210 includes power management logic 230 for regulating power use and allocation within the control console 140.

[0084] The fourth group of components may include a processor and memory 205, namely, a processor 712 that accesses logic in memory 715, such as non-volatile memory (e.g., electrically erasable programmable read-only memory (flash memory), battery-backed random access memory, etc.). The processor 712 is configured to control the functions of the AI-based boot system 700, thereby acting as a control processor. Memory 715 is characterized by an AI-based visualization control 180 and an AI-based boot assist logic 190. Specifically, the AI-based visualization control 180 includes visualization region generation logic 720 and visualization region positioning logic 725. The AI-based boot assist logic 190 includes visualization region monitoring logic 740, notification logic 745, and image enhancement and overlay logic 750, the operability of which logics 740-750 are described below.

[0085] More specifically, when executed by the processor 712, the visualization region generation logic 720 and visualization region positioning logic 725 of the AI-based visualization control 180 are configured to generate and reposition sub-regions (visualization regions 195) of the total imaging region captured by the ultrasound beam 162 as needed, based on information received from the medical component tracking subsystem (e.g., sensor array 270 and piezoelectric I / O component 260).

[0086] Specifically, probe 160 is used in conjunction with ultrasound-based visualization of a vascular system (e.g., veins or arteries) to prepare for insertion of a medical component 110 (e.g., needle, catheter, etc.) into the vascular system 120. This visualization provides real-time ultrasound guidance and helps reduce complications typically associated with such insertion. As shown, according to one embodiment of this application, probe 160 includes a housing 760 characterized by a button / memory controller interface 275, a sensor array 270 including a piezoelectric array 340, a controller 360, and / or a haptic feedback device 380, the same operation of which has been described above.

[0087] Here, processor 712 is configured to receive images of a patient region (e.g., skin surface and subcutaneous tissue) captured by an ultrasound beam 162 emitted from probe 160. Additionally, AI-based visualization control 180 is configured to receive orientation measurements 765 of needle 110 from probe 170, and based on these orientation measurements 765, visualization region generation logic 720 generates a visualization region 195 when executed by processor 712. This visualization region 195 may correspond to a portion of the total imaging region 192 presented by guidance system 100 (see [link to documentation]). Figures 8A-8E In this implementation, the visualization area is significantly smaller in size than the total imaging area (e.g., less than 1 / 10 of the size) in order to (i) reduce the complexity of analyzing the visualization area by the visualization area monitoring logic 740 (determining the presence of a needle when a needle reflection is detected) and (ii) reduce the waiting time for reporting analysis results. The size of the visualization area can be static or dynamic (e.g., based on needle gauge, medical component type, etc.).

[0088] Similarly, based on orientation metric 765, visualization region localization logic 725, when executed by processor 712, can modify the position of the visualization region at least in part based on the position, orientation, and current propulsion path of needle 110. More specifically, visualization region localization logic 725 can modify the position of the visualization region to intercept the propulsion of needle 110 before contacting the outer wall surface of target vascular system 120.

[0089] When executed by processor 712, visualization area monitoring logic 740 is configured to monitor the visualization area for needle reflection, i.e., artifacts indicating that needle 110 has entered and / or left the visualization area 195. Upon detecting that needle 110 has entered the visualization area, visualization area monitoring logic 740 signals notification logic 745 to initiate a visual notification to monitor 150 upon detection that a needle has passed through or is present in the visualization area. Additionally or alternatively, notification logic 745 may be configured to initiate an auditory notification to an audio device (e.g., a speaker) 775 associated with monitor 150, or a tactile notification to a tactile feedback device 380 pointing towards probe 170, upon detection that a needle has passed through or is present in the visualization area.

[0090] The audio / visual / tactile notification logic 745 may include hardware and / or software that signals associated devices (e.g., a monitor, computer, audio device, and / or other display) to provide a user with audio, visual, and / or tactile indication / notification that the medical component (needle) 110 is near a predetermined location. The audio, visual, and / or tactile notification may take various forms, including as a graphic or digital display, a graphic or digital display of the distance between the needle 110 and the vascular system, a graphic representation of the movement of the needle 110 relative to the vascular system, a sound whose frequency changes according to the position of the needle 110 relative to the desired location (e.g., a buzzing sound), a display color that changes according to the position of the needle (e.g., red if the tip is not properly positioned), vibrations of one or more components of the system (e.g., tactile feedback), temperature changes of one or more components of the system, and combinations thereof.

[0091] Image enhancement and overlay logic 750 is configured to overlay a visualized region onto an image of the target vascular system captured by ultrasound. Additionally, logic 750 can be configured to identify an image associated with needle 110 and apply imaging enhancement to the needle image to better identify the presence, location, and / or orientation of the needle.

[0092] refer to Figures 8A-8E , Figure 7 An exemplary implementation of an AI-based guidance system generates and monitors a visualization area within a visualization region 195 where a needle reflection exists, which triggers enhanced displays of medical components (e.g., needles) and audio / visual / tactile notifications.

[0093] like Figure 8A As shown, a first screenshot 800 of an ultrasound image (or series of ultrasound images) captured by a sensor array located within the probe and presented on monitor 150 is displayed. Here, the first screenshot 800 shows the needle 110 advancing through subcutaneous tissue 805 toward the vascular system 120. The visualization area 195 is... Figure 7 A visualization region generation logic 720 generates a visualization region 195 that is superimposed in real time on an ultrasound image 810, which displays the target vascular system 120 and the subcutaneous tissue 805 surrounding the vascular system 120. The visualization region 195, indicated by a dashed box, defines the area within which the needle reflection is monitored.

[0094] Furthermore, regarding this implementation method, such as Figure 8B As shown in the second screenshot 820, the AI-based guidance system tracks the positioning and propulsion of the needle 110 according to multiple degrees of freedom of motion. Here, the position of the visualization area 195 is adjusted to accommodate the angle adjustment 825 of the needle 110. Repositioning is determined based on orientation measures corresponding to or related to the xyz coordinate space, pitch, and / or yaw (e.g., orientation) of the needle 110.

[0095] like Figure 8C As shown in the third screenshot 830, this tracking of the needle 110 and repositioning of the visualization area 195 allows the distal end 112 of the needle 110 to be guided and positioned to intersect with the boundary 840 of the visualization area 195. Once the distal end 112 of the needle 110 is detected to have entered the visualization area 195 (e.g., based on a detected needle reflection associated with the distal end 112), the visualization area monitoring logic 740 (see [link to relevant documentation])... Figure 7 The notification logic 745 is signaled to provide a notification (e.g., a notification associated with a visual notification, an auditory notification, a tactile notification, or any combination thereof) to a device associated with the console 140 (e.g., a monitor 150, a speaker 155, a probe 160).

[0096] In addition, through Figure 7 When the visualization area monitoring logic 740 detects a needle reflection within the visualization area 195, such as Figure 8D As shown in the fourth screenshot 850, the image enhancement and overlay logic 750 applies one or more imaging enhancements 845 to items within or forming the visualization region 195, such as the needle 110, the boundary 840 of the visualization region 195, etc. Imaging enhancements may include, but are not limited to, altering the displayed image of the needle (e.g., changing its color, highlighting, brightening, or darkening it relative to the rest of the ultrasound image), changing the resolution of the visualization region 195 by generating a higher-resolution virtualization corresponding to the visualization region, etc.

[0097] Now, as Figure 8E As shown in the fifth screenshot 860, when the needle 110 is removed from the visualization area 195, the visualization area monitoring logic 740 signals the AI-based image enhancement and overlay logic 750 to stop generating image enhancement. Optionally, when the needle 110 is removed from the visualization area 195, the visualization area monitoring logic 740 signals the AI-based notification logic 745 to generate a notification (visual, auditory, and / or tactile) to inform the clinician that the needle 110 has left the visualization area 195.

[0098] Now for reference Figures 9A-9B This shows the result of Figure 7 An exemplary implementation of an operation method based on AI-guided and assisted logic. Here, as... Figure 9AAs shown, a visualization region, substantially smaller than the total imaging area, is generated and presented on the monitor of the AI-based guidance system (operation 900). According to one embodiment, the visualization region is overlaid with a portion of the total imaging area near the target vascular system. Subsequently, the positioning of the visualization region is adjusted based on communication between the probe interface logic and the AI-based visualization controls. These adjustments, made via the AI-based visualization controls, position the visualization region around the vascular system, thereby intercepting the advance of medical components (e.g., needles) directed towards the vascular system (operation 905).

[0099] In response to the failure to detect a needle reflection, the AI-based guidance-assist logic continues to monitor for and identify the presence of needle artifacts (e.g., needle reflections) within the visualization area (operations 910, 912). However, upon detecting a needle reflection, the AI-based guidance-assist logic identifies the needle as entering the visualization area and generates a notification to alert the clinician to the needle's location (operations 914, 915). Certain images within the visualization area are selected for image enhancement via the AI-based guidance-assist logic, such as altering the needle's displayed appearance (e.g., changing color, highlighting, or outlining) (operation 920). Image enhancement continues while the needle remains within the visualization area (operations 925, 927).

[0100] like Figure 9B As shown, in response to the AI-based guidance assist logic detecting that the needle has been removed from the visualization area, image enhancement is stopped (operations 929, 930, 935). Optionally, the AI-based guidance assist logic can generate an assist notification to alert the clinician to needle movement away from the target vascular system (operation 940). Communication between the probe interface logic and the AI-based visualization control continues (in the case of a second needle insertion, etc.) until the guidance session (ultrasound session) terminates (operations 945, 950).

[0101] Embodiments of the invention may be practiced in other specific forms without departing from the spirit of this application. The described embodiments are considered to be illustrative in all respects only, and not restrictive. Therefore, the scope of the embodiments is indicated by the appended claims rather than by the foregoing description. All variations within the meaning and scope of the equivalents of the claims are included within their scope.

Claims

1. A boot system, characterized in that, include: probe; and A control console, communicatively connected to the probe, the control console comprising: A visualization region generation logic is used to generate a visualization region that is a subset of the total imaging region presented by the guidance system and is close to the target destination, and to overlay the visualization region onto the ultrasound image in real time. and Sensor analysis logic is used to (i) monitor the presence of a medical component within the visualized area and (ii) provide feedback to the device to generate a notification that the medical component is present within the visualized area; The console also includes image enhancement and overlay logic to apply one or more imaging enhancements to items within the visualization area or items forming the visualization area when the presence of the medical component is detected within the visualization area. The medical component is associated with a magnetic element, the probe detects the magnetic field of the magnetic element, and the visualization area is determined by the position and orientation of the medical component based on the magnetic element.

2. The boot system according to claim 1, characterized in that, The sensor analysis logic is configured to monitor needle feedback of the sound waves emitted and received by the probe.

3. The boot system according to claim 1, characterized in that, The medical component is a needle, and when the probe is operated as part of an ultrasound system, needle reflection is detected from the needle.

4. The boot system according to claim 1, characterized in that, The sensor analysis logic is configured to be based on feedback from a magnetic field monitoring needle, the magnetic field being detected by the probe based on magnetic elements arranged within the medical component.

5. The boot system according to claim 1, characterized in that, The sensor analysis logic is configured to provide feedback that visually identifies the presence of the medical component within the visualized area.

6. The guiding system according to claim 5, characterized in that, The sensor analysis logic generates a signal to illuminate a light element within the probe, the light element indicating that the medical component is close to the vascular system, which is the target destination, in the visualization area.

7. The boot system according to claim 1, characterized in that, The sensor analysis logic is configured to provide feedback to the audio device to generate an auditory notification to identify the presence of the medical component in the visual area near the vascular system, which is the target destination.

8. The boot system according to claim 1, characterized in that, The sensor analysis logic is configured to provide feedback to a tactile feedback device arranged within the probe to generate tactile notifications as controls for the operation of the probe.

9. The boot system according to claim 1, characterized in that, The console further includes: an AI-based visualization control to generate the visualization area; and AI-based guidance assistance logic to (i) monitor the presence of the medical component near the target destination within the visualization area, (ii) provide feedback to the device to generate a notification that the medical component is present within the visualization area, and (iii) generate imaging enhancement and apply the imaging enhancement to at least a portion of the imaging data within the visualization area to assist the medical component in advancing toward the target destination, which is a vascular system.

10. The guiding system according to claim 1, characterized in that, The imaging enhancement includes color overlay of at least a portion of the image of the medical component to provide better clarity regarding the location of the medical component.

11. The boot system according to claim 1, characterized in that, The imaging enhancement includes a virtual representation of the medical component and vascular system in the visualization area.

12. The boot system according to claim 1, characterized in that, The medical component is a needle, and the notification includes activating a light on the probe or a light on the console to indicate whether the needle is entering or leaving the target destination.

13. The guidance system according to any one of claims 1 to 12, used to assist in the advancement of a medical component within a patient's body, characterized in that, The console includes: (i) an AI-based visualization control configured to generate and locate a visualization area between the medical component and the patient's target vascular system; and (ii) AI-based guidance assistance logic to (i) detect the presence of the medical component within the visualization area, (ii) provide feedback to the device to generate a notification of the presence of the medical component within the visualization area, and (iii) generate imaging enhancements and apply the imaging enhancements to at least a portion of the imaging data within the visualization area to assist in advancing the medical component toward the vascular system. The visualization area is a sub-region of the total imaging area presented by the console.

14. The guiding system according to claim 13, characterized in that, The AI-based visualization control includes: (i) visualization region generation logic to generate the visualization region by overlaying a portion of the total imaging region presented by the guidance system; and (ii) AI-based visualization region positioning logic to locate and reposition the visualization region within the total imaging region as needed along a path that captures the visualization region.

15. The guiding system according to claim 13, characterized in that, The imaging enhancement includes color overlay of at least a portion of the image of the medical component to provide better clarity regarding the location of the medical component.

16. The guiding system according to claim 13, characterized in that, The medical component is a needle, and the imaging enhancement includes activating a light on the probe or a light on the console to indicate whether the needle is entering or leaving the target destination.

17. The guiding system according to claim 13, characterized in that, The medical component is a needle, and when the console is operated as part of an ultrasound system, a reflection of the needle is detected from the returning sound waves generated by the probe.

18. The guiding system according to claim 13, characterized in that, The medical component is a needle that includes magnetic elements, thereby allowing the probe to detect a magnetic field.

Images