Ultrasound-equipped catheter stylet system

Abstract

Apparatus, methods, systems, and program products for an ultrasound-equipped catheter stylet system are disclosed. Apparatus (104) includes a catheter (202) and a stylet (204) configured to be inserted into the catheter (202). The stylet (204) comprises a shaft (301) having a first end (305) and a second end (303), and an ultrasound transceiver (306) coupled to the first end (305) of the shaft (301), the ultrasound transceiver (306) being configured to transmit and receive ultrasound signals.

Description

Technical Field

[0001]

[0001] The present invention relates to imaging, and more particularly to an ultrasonic-equipped catheter-stylet system.

Background Art

[0002]

[0002] Diagnostic ultrasound is used in many medical fields as a means for identifying biological structures and guiding the delivery of needles, devices, and pharmaceuticals. Many ultrasound probes have been developed to optimize resolution, depth, and field of view for specific uses, including curved, linear, vaginal, rectal, and cardiac probes.

Summary of the Invention

[0003]

[0003] An apparatus for an ultrasonic-equipped catheter-stylet system is disclosed. Also, a system and method perform the functions of this apparatus. In one embodiment, the apparatus includes a catheter and a stylet configured to be inserted into the catheter. The stylet, in one embodiment, includes a shaft having a first end and a second end, and an ultrasonic transceiver coupled to the first end of the shaft, the ultrasonic transceiver being configured to transmit and receive ultrasonic signals.

[0004]

[0004] In one embodiment, the system includes a catheter and a stylet inserted into the catheter. In one embodiment, the stylet includes a shaft having a first end and a second end, and an ultrasonic transceiver coupled to the first end of the shaft, the ultrasonic transceiver being configured to transmit and receive ultrasonic signals, and a position sensor for detecting the position of the stylet relative to a fixed point. In one embodiment, the system is configured to receive a signal from the ultrasonic transceiver, generate a multi-dimensional graphic based on the received signal, and present the multi-dimensional graphic on a display device.

[0005]

[0005] In one embodiment, the method is configured to insert a stylet into a catheter, insert the catheter into the body, cause an ultrasonic transceiver to generate an ultrasonic signal, move the stylet in a cone shape as the catheter is inserted into the body, receive position data from a position sensor and signal data from the ultrasonic transceiver while moving the stylet, and generate a multidimensional graphic of the part of the body into which the catheter is inserted based on the position data and signal data.

[0006]

[0006] In order for the advantages of the present invention to be easily understood, the present invention, which has been briefly described above, will be further specified and described with reference to specific embodiments shown in the accompanying drawings. With the understanding that these drawings only depict typical embodiments of the present invention and should not be considered to limit its scope, the present invention will be described and explained more specifically and in detail with reference to the accompanying drawings. [Brief explanation of the drawing]

[0007]

[0007] [Figure 1] An embodiment of an ultrasound-equipped catheter stylet system, as disclosed herein, is shown.

[0008] [Figure 2] An embodiment of a catheter stylet system according to the subject matter disclosed herein is shown.

[0009] [Figure 3] An embodiment of the stylet according to the subject matter disclosed herein is shown.

[0010] [Figure 4A] This specification shows one embodiment of a stylet inside a catheter according to the subject matter disclosed herein.

[0011] [Figure 4B] This specification shows one embodiment of a stylet inside a catheter according to the subject matter disclosed herein. [Figure 4C]This specification shows one embodiment of a stylet inside a catheter according to the subject matter disclosed herein.

[0013] [Figure 4D] This specification shows one embodiment of a catheter with a stylet inside the subject disclosed herein.

[0014] [Figure 5A] An embodiment of the stylet axis configuration according to the subject matter disclosed herein is shown.

[0015] [Figure 5B] An embodiment of the stylet axis configuration according to the subject matter disclosed herein is shown.

[0016] [Figure 6A] In accordance with the subject matter disclosed herein, an embodiment of a catheter stylet system inserted into the body is shown.

[0017] [Figure 6B] In accordance with the subject matter disclosed herein, an embodiment of a catheter stylet system inserted into the body is shown.

[0018] [Figure 6C] This specification shows one embodiment of output using a catheter stylet system according to the subject disclosed herein.

[0019] [Figure 7] This specification shows one embodiment of an apparatus for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein.

[0020] [Figure 8] This specification shows one embodiment of a method for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein.

[0021] [Figure 9] This specification shows one embodiment of a method for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein.

[0022] [Figure 10] This specification shows one embodiment of a method for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein. [Modes for carrying out the invention]

[0008]

[0023] Diagnostic ultrasound is used in many medical fields to identify biological structures and to guide the delivery of needles, instruments, and medications. Many ultrasound probes have been developed to optimize resolution, depth, and field of view for specific uses, including curved, straight, vaginal, rectal, and cardiac probes. Each of these devices relies on the surface stability of the ultrasound probe relative to the target biological structure. These probes then remain on the surface of the imaging target while needles, instruments, etc., are advanced toward their targets. This technique minimizes the invasiveness of the procedure or imaging. Unfortunately, the use of ultrasound is limited to applications where a surface probe can provide adequate imaging to guide deep interventions. Furthermore, this technique requires considerable training to understand and adapt to the limitations of imaging and intervention on a separate plane.

[0009]

[0024] Ultrasound imaging is increasingly being used because the output images depict biological structures familiar to medical professionals. 3D ultrasound techniques are also becoming more widespread because they convert 2D slices across the entire biological structure into three-dimensional structures. These techniques are already used in multiple medical fields, including cardiac electrophysiology, general surgery, and obstetrics. These methods utilize various algorithms to stack B-mode ultrasound slices to create three-dimensional images. A limitation of these methods is the size of the ultrasound array used to acquire the B-mode images.

[0010]

[0025] As medical technology advances, there is a need for ways to enable diagnostic ultrasound to be used at a sufficiently small scale so that it can become one of the intermediary devices. Miniaturizing the ultrasound transducer results in a significant decrease in resolution and, furthermore, a significant decrease in the ability to use phased arrays or B-mode arrays for imaging. However, it is safe to say that B-mode and phased arrays cannot approach the physical size required to be part of an invasive device.

[0011]

[0026] A-mode ultrasound has long been overlooked because it only generates 1D signals. Currently, there are very few applications in the medical field where 1D signals are considered useful for conveying clinical decisions. On the other hand, A-mode transducer technology is capable of integrating sufficiently small transducers into invasive devices (<2.0 mm). If a method exists to convert 1D signals into useful clinical images, it will be possible to add imaging diagnostics to most invasive and minimally invasive procedures in the medical field.

[0012]

[0027] External ventricular drainage (EVD) is a device used to release elevated intracranial pressure in cases of cerebrospinal fluid (CSF) obstruction or trapped blood within the brain. Like a flexible plastic catheter, EVDs are placed by neurosurgeons or neurocritical care physicians into one or more ventricles through the brain, releasing intracranial pressure and preventing incarceration, significant maltality, or death in severe cases. In cases of head trauma, in most cases, there is insufficient time for imaging before EVD placement, and a freehand pass technique is performed using the patient's anatomical surface targets on the skull. Because cerebral hemorrhage and head trauma can damage the normal biological structure of the brain, this freehand pass technique often requires multiple attempts for the surgeon to accurately reach the desired ventricle, potentially leading to complications such as further bleeding and inadvertent placement into normal brain tissue.

[0013]

[0028] Conventional EVDs have various constraints and drawbacks, due to which the accuracy of surgeons is significantly impaired. Among them are the inability to grasp in real time the changes in the patient's neuroanatomical structure from the normal state, the inability to obtain real-time feedback on the trajectory accuracy of surgeons, the inability to obtain objective information in real time for determining the distance to the target, the inability to adjust the trajectory midway during insertion, and the inability to obtain real-time verification of the size of the ventricle.

[0014]

[0029] Based on the above, it is clear that a real-time imaging modality that enables surgeons to see their targets in real time, especially in emergency situations, would be very effective. The solution disclosed in this specification describes an ultrasonic-equipped catheter-stylet system that achieves these objectives. This technology can be used in procedures and markets other than EVD and shunt placement, simply by changing the outer diameter of the stylet shaft, the ultrasonic frequency for adjustment according to the expected target depth, and the catheter to be introduced.

[0015]

[0030] The standard fishmouth stylet, which is often used to pass an EVD catheter into the lateral ventricle, is replaced with a rigid stylet device having an ultrasonic transducer at its tip, enabling a manual scan to be performed and the underlying brain anatomy to be imaged. The surgeon or other healthcare provider can visualize the ventricular wall interface, anechoic fluid-filled ventricles, major blood vessels, and superficial brain tissue. Real-time imaging allows the healthcare provider to determine the trajectory and maintain the trajectory for those EVD catheters to pass through the brain and reach their target, i.e., into the ventricle. Live imaging during this procedure further aids in efficient and accurate EVD insertion in the initial trial and suppresses the adverse effects of pushing the catheter through the brain tissue. Thus, the subject matter herein is directed to generating a multi-dimensional image that takes into account the position and orientation of the ultrasonic transducer in an inexpensive manner, using an A-mode ultrasonic signal while associating instrument stereotaxis with real-time imaging.

[0016]

[0031] FIG. 1 shows one embodiment of an ultrasonic-equipped catheter stylet system 100 according to the subject matter disclosed herein. The system 100, in one embodiment, includes a computing device 102, a display device 103, a catheter stylet system 104, an imaging device 110, one or more servers 112, and a data network 114. In a particular embodiment, a specific number of computing devices 102, display devices 103, catheter stylet systems 104, imaging devices 110, one or more servers 112, and data networks 114 are shown in FIG. 1, but it will be appreciated by those skilled in the art that the system 100 may include any number of these components from the perspective of the present disclosure.

[0017]

[0032] In one embodiment, the system 100 includes one or more computing devices 102. The computing device 102 may be one or more of the following: a desktop computer, a laptop computer, a tablet computer, a smartphone, a smart speaker (e.g., Amazon Echo®, Google Home®, Apple HomePod®), an Internet of Things device, a set-top box, a gaming console, a smart TV, a smart watch, an optical head-mounted display (e.g., a virtual reality headset, smart glasses, headphones, etc.), a high-definition multimedia interface ("HDMI") or other electronic display dongle, a personal digital assistant, a digital camera, a video camera, or other computing devices. Other computing devices include processors (e.g., central processing units ("CPU"), processor cores, field-programmable gate arrays ("FPGA") or other programmable logic, application-specific integrated circuits ("ASIC"), controllers, microcontrollers, and / or other semiconductor integrated circuit devices), volatile memory and / or non-volatile storage media, a display 103, connections to the display, and / or similar.

[0018]

[0033] In one embodiment, the catheter stylet system 104, described in more detail below, is communicatively connected to a computing device 102 via a wired connection 106 and / or a wireless connection 1018. In such an embodiment, the wired connection 106 may include data connections such as Ethernet connections, serial bus connections (e.g., Universal Serial Bus (USB)), coaxial cables, etc. In one embodiment, the wireless connection 108 may include short-range wireless connections such as Bluetooth® connections, near-field communication (NFC) connections, radio frequency (RF) connections, Wi-Fi connections, and / or similar.

[0019]

[0034] In one embodiment, the imaging device 110 is configured to receive data signals, such as ultrasound data signals, from the catheter stylet system 104 (e.g., via a wired 106 or wireless 108 connection) during EVD or other procedures, and to generate images or graphics of the part of the user 116's body into which the catheter stylet system 104 is inserted, in order to guide and assist the physician in catheter insertion. The imaging device 110 is described in more detail below.

[0020]

[0035] In certain embodiments, the imaging device 110 may include a hardware device such as a secure hardware dongle or other hardware appliance device (e.g., a set-top box, network appliance, etc.) that connects to a device such as a head-mounted display, laptop computer, server 112, tablet computer, smartphone, network router, or switch by either a wired connection (e.g., USB connection) or a wireless connection (e.g., Bluetooth®, Wi-Fi, Near Field Communication ("NFC"), etc.). Furthermore, this hardware device connects to an electronic display device (e.g., a television or monitor using an HDMI port, DisplayPort port, Mini DisplayPort port, VGA port, DVI port, etc.) and / or similar. The hardware appliance of the imaging device 110 may include a power interface, a wired and / or wireless network interface, a graphical interface for connecting to a display, and / or semiconductor integrated circuit devices configured to perform functions described herein with respect to the imaging device 110, such as those described below.

[0021]

[0036] In such embodiments, the imaging device 110 may include firmware for a field-programmable gate array (FPGA) or other programmable logic, a semiconductor integrated circuit device (e.g., one or more chips, dies, or other discrete logic hardware), a microcontroller, an application-specific integrated circuit (ASIC), a processor, a processor core, etc. In one embodiment, the imaging device 110 may be mounted on a printed circuit board having one or more lines or connections (e.g., to volatile memory, non-volatile storage media, network interfaces, peripheral devices, graphical / display interfaces, etc.). The hardware appliance may include one or more pins, pads, or other electrical connections (e.g., communicating via one or more lines, such as those on a printed circuit board) configured to send and receive data, as well as one or more hardware circuits and / or other electrical circuits configured to perform various functions of the imaging device 110.

[0022]

[0037] In certain embodiments, the semiconductor integrated circuit device or other hardware appliance of the imaging device 110 includes and / or is communicatively coupled to one or more volatile memory media. These memory media may include, but are not limited to, random access memory (RAM), dynamic RAM (DRAM), cache, etc. In one embodiment, the semiconductor integrated circuit device or other hardware appliance of the imaging device 110 includes and / or is communicatively coupled to one or more non-volatile memory media. One or more non-volatile memory media may include, but are not limited to, NAND flash memory, NOR flash memory, nano random-access memory (nanoRAM or NRAM), nanocrystal wire-based memory, silicon oxide sub-10 nanometer process memory, graphene memory, silicon oxide nitride oxide silicon (SONOS), resistive random-access memory (RRAM), programmable metallization cell (PMC), conductive-bridging RAM (CBRAM), magnetoresistive random-access memory (MRAM), dynamic RAM (DRAM), phase-change RAM (PRAM or PCM), magnetic storage media (e.g., hard disk, tape), optical storage media, etc.

[0023]

[0038] In one embodiment, one or more servers 112 may be embodied as blade servers, mainframe servers, tower servers, rack servers, and / or similar. One or more servers 112 may be part of a data center, cloud servers, and may be located remotely and / or locally with respect to computing devices 102, and / or similar. One or more servers 108 may be communicatively coupled to computing devices 102 through a data network 114 (e.g., network-connected) and may be configured to execute or run signal processing, image processing, artificial intelligence (AI), and / or machine learning algorithms, programs, applications, processes, and / or similar.

[0024]

[0039] In one embodiment, the data network 106 includes a digital communication network that transmits digital communications. The data network 106 may include wireless networks such as wireless cellular networks, local wireless networks such as Wi-Fi networks, Bluetooth® networks, near-field communication (NFC) networks, ad-hoc networks, mesh networks, and / or similar. The data network 106 may also include wide-area networks (WANs), storage area networks (SANs), local area networks (LANs), fiber optic networks, the Internet, or other digital communication networks. The data network 106 may also include two or more networks. The data network 106 may include one or more servers, routers, switches, and / or other network equipment. Furthermore, the data network 106 may also include one or more computer-readable storage media, such as hard disk drives, optical drives, non-volatile memory, RAM, and the like.

[0025]

[0040] The wireless connection may be a cellular network. Alternatively, the wireless connection may employ a Wi-Fi network based on any one of the IEEE 802.11 standards. Or, the wireless connection may be a Bluetooth® connection. In addition, the wireless connection may employ radio-frequency identification (RFID) communication, including RFID standards defined by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American Society for Testing and Materials (ASTM®), the DASH® Union, and EPCGlobal®.

[0026]

[0041] Alternatively, the wireless connection may employ a ZigBee® connection based on the IEEE 802 standard. In one embodiment, the wireless connection employs the Z-Wave® technology designed by Sigma Designs®. Alternatively, the wireless connection may employ an ANT® and / or ANT+® connection. The wireless connection may also be an infrared connection, including a connection that at least conforms to the Infrared Physical Layer Specification (IrPHY) defined by the Infrared Data Association® (IrDA®). Alternatively, the wireless connection may be a cellular telephone network connection.

[0027]

[0042] Figure 2 shows one embodiment of a catheter stylet system 104 according to the subject disclosed herein. In one embodiment, the catheter stylet system 104 includes a catheter 202 and a stylet 204. As used herein, the catheter 202 may refer to a flexible tube that is inserted through a narrow opening into a body cavity, such as the user's head or bladder. In one embodiment, the catheter 202 is made of a flexible tubular material such as latex, polyurethane, or silicone. The catheter 202 may include a number of openings 206, slits, holes, etc., to allow fluid to enter the catheter 202 and be discharged from the body. In one embodiment, the catheter 202 includes measuring lines or guides along its outer surface, which are used to indicate the insertion depth of the catheter 202.

[0028]

[0043] In relation to the subject matter herein, the end of the catheter 202 may include a tip 208, which is used to guide the catheter 202 through the body, for example, through tissues and other materials. In one embodiment, the tip 208 is made of a low-luminosity material. As used herein, the low-luminosity material may include a material that is translucent to ultrasonic waves, for example, ultrasonic waves. That is, in such an embodiment, the low-luminosity tip 208 allows ultrasonic waves transmitted from, for example, the stylet 204 to travel through the tip without causing much interference, even if interference occurs. In one embodiment, the low-luminosity tip has a configuration that filters or focuses the ultrasonic signal. Such a configuration may include the shape of the low-luminosity tip, the size of the low-luminosity tip, the thickness of the low-luminosity tip, the presence of a cavity inside the low-luminosity tip, or a combination thereof.

[0029]

[0044] Figure 3 shows one embodiment of a stylet 204 according to the subject matter disclosed herein. The stylet 204 may include a shaft 301 having a near end 303 and a far end 305. The stylet 204 may be formed, shaped, or otherwise configured to fit within a catheter, for example, the catheter 202 described earlier with reference to Figure 2. The stylet 204 may be made of a substantially rigid material such as plastic, metal (e.g., stainless steel), polymer, etc. In one embodiment, the stylet 204 may be a disposable device or may be sterilized to allow for reuse.

[0030]

[0045] In one embodiment, the stylet 204 comprises various components. In a particular embodiment, the stylet 204 includes an acoustic lens 302 that focuses ultrasonic or ultrasonic signals from an ultrasonic transceiver 306. In one embodiment, the stylet 204 includes an acoustic matching layer 304. The acoustic matching layer 304 forms an acoustic impedance gradient such that acoustic energy from the transceiver 306 penetrates body tissue and reflected acoustic waves (echoes) return to the transceiver 306 and can be detected.

[0031]

[0046] In one embodiment, the transceiver 306 includes an ultrasonic transducer, but any form of transceiver capable of transmitting and receiving ultrasound or ultrasonic signals is acceptable. In one embodiment, the transceiver 306 includes, for example, a piezoelectric material transducer, which is configured to convert the received ultrasonic signal or echo into a signal and transmit it to the computing device 102.

[0032]

[0047] The transceiver 306 can be configured to transmit ultrasonic signals according to a predetermined pattern and / or spread. In a particular embodiment, the transceiver 306 is communicably coupled to a computing device 102 via a wired connection 106 or a wireless connection 108, and receives configuration information, such as the pattern, spread, signal strength, frequency, or other configuration of the transceiver 306, and sends signal information to the computing device 102 from the received ultrasonic waves in response to the transmission of ultrasonic waves from the transceiver 306.

[0033]

[0048] In one embodiment, the ultrasonic transceiver 306 is configured to transmit and receive A-mode ultrasonic signals. As used herein, an A-mode ultrasonic signal may refer to an ultrasonic signal generated by a single transceiver that scans linearly across the whole body using echoes that can be plotted as a function of depth. In another embodiment, the ultrasonic transceiver 306 is configured to transmit and receive B-mode ultrasonic signals. As used herein, a B-mode ultrasonic signal may refer to an ultrasonic signal used to scan a surface across the whole body using multiple transceivers. In such an embodiment, the stylet 204 includes multiple transceivers 306 configured to transmit and receive multiple ultrasonic signals.

[0034]

[0049] In one embodiment, the transceiver 306 can be shaped according to the application and target of the ultrasonic signal. For example, the transceiver 306 may have a concave focusing transmitting surface, a flat transmitting surface, a convex focusing transmitting surface, etc. In a particular embodiment, a concave focusing transmitting surface may be able to obtain the best resolution and may be most effective in applications with size constraints, such as small incident points, for example, EVD applications with a diameter of less than 2.5 mm.

[0035]

[0050] In one embodiment, the focal radius of the transceiver 306 can be designed to have a beneficial focusing interaction with the catheter tip 208 and / or the acoustic lens 302. The shape of the catheter tip 208 and / or the acoustic lens 302 can further be configured to focus the ultrasonic signal, thereby increasing resolution and addressing improved imaging accuracy. Ultrasound waves can be focused using refraction by passing them through a plurality of angular, curved, or strategically shaped surfaces or spaces (volumes).

[0036]

[0051] One form of this multidimensional spatial representation can utilize typical cylindrical, columnar, or beam-specific near-zone or far-zone spaces derived from the A-mode converter signal. These typical signal spaces are specific to the converter being used. The shape of the typical signal space can be conveyed from the converter's design elements or finite element modeling of the beam diffusion pattern. The converter-specific typical space (volume) enables high-precision multidimensional representation across a wide range of depths.

[0037]

[0052] In one embodiment, the ultrasonic transceiver 306 is detachable from the shaft 301 before the stylet 204 is removed from the catheter 202. In such an embodiment, the shaft 301 may include a mechanism, such as a button, for detaching the ultrasonic transceiver 306 from the shaft 301, which decouples, or in other words, disconnects, the ultrasonic transceiver 306 from the shaft 301. Thus, the ultrasonic transceiver 306 can be implanted in the patient for continuous monitoring.

[0038]

[0053] In one embodiment, the stylet 204 includes a backing layer 308. In one embodiment, the backing layer 308 prevents sound waves from reflecting back to the transceiver. If sound waves reflect back to the transceiver, noise may be generated. Furthermore, the backing layer 308 may also affect the characteristics of the sound waves, such as the sensitivity and signal-to-noise ratio.

[0039]

[0054] In one embodiment, the stylet 204 also includes other components such as a position sensor 310. The position sensor 310 may include one or more induction coil sensors. The induction coil sensors are configured to detect changes in position, such as inertial measurement unit (IMU) sensors, accelerometers, gyroscopes, angel transducers, and / or similar. The positioning information is transmitted to a computing device 102 and used to construct an image or graphics. The image or graphics are generated using ultrasonic signals. For example, a fixed point relative to the position sensor 310 may be the far end of the stylet where the ultrasonic transceiver 306 is located. Moving the stylet 204 in a cone shape creates a conical map of the device's movement. The position sensor 310 can detect the device's movement at known locations near the device's tip. As will be described in more detail below, by detecting the position of a nearby device within this conical map, it becomes possible to stitch together 1D data to create a 2D or 3D image.

[0040]

[0055] Figures 4A–4D show different shapes of stylet 204 inside catheter 202 according to the subject disclosed herein. In certain embodiments, EVD and other applications for fluid leakage from multiple body parts depend on the volume of catheter 202 to leak fluid such as CSF from the ventricles and to show the surgeon that the ventricular cavity has been breached. Ideally, the catheter 202 should not be completely filled with fluid, but should be able to pass alongside the rigid material occupying the lumen, so that the surgeon can be shown that the ventricular cavity has been breached based on the presence of CSF before the CSF is expressed externally, without the need to remove the stylus 204.

[0041]

[0056] In other words, different configurations can be used for the stylet 204 or the stylet tip to allow the fluid to avoid the stylet 204, i.e., to flow around the stylet 204. For example, the stylet 204 may have a rectangular shape (Figure 4A), a hexagonal shape (Figure 4B), a machined shape (Figure 4C), or an elliptical shape (Figure 4D). As shown in each of Figures 4A to 4D, the shape of the stylet 204 creates a gap between the catheter 202 and the stylet 204, thereby allowing the fluid to flow around the stylet 204, i.e., to avoid the stylet 204 and flow out from the end of the catheter 202.

[0042]

[0057] Figures 5A and 5B show stylets 204 having different axial configurations according to the subject matter disclosed herein. Another method of creating a gap between the stylet 204 and the catheter 202 and allowing fluid to flow around the stylet 204, i.e., to avoid it, is to introduce grooves, furring, channels, etc., into the stylet shaft 301. Figure 5A shows a stylet shaft 301 with furring engraved, formed, or cut into the shaft 301, and Figure 5B shows a stylet shaft 301 with channels or grooves engraved, formed, or cut into the shaft 301. In either embodiment, when the stylet 204 is inserted into the catheter 202 and the catheter 202 is inserted into a part of the body, as the catheter 202 is inserted, fluid from the body can avoid the stylet 204 and be discharged through the catheter 202. In this way, fluids such as CSF can be generated without removing the stylet 204 from the catheter 202, while the rigidity of the stylet 204 is optimized for handling and the outer diameter is maximized for optimal imaging and resolution.

[0043]

[0058] Figure 6A shows one embodiment of the catheter stylet system 104 as inserted into the body in accordance with the subject matter disclosed herein. In one embodiment, the catheter stylet system 104 includes an anchor device 606. The anchor device 606 is inserted into an opening 604 or bore hole in the body 602, in this case the skull of the user's head. In one embodiment, the anchor device 606 includes an insertion portion 608 that penetrates into the opening 604 and a lip portion 609 that sits on the outer edge of the opening 604. An opening 610 that penetrates the anchor device 606 allows the catheter stylet system 104 to pass through the anchor device 606 and reach the body 602, for example, the inside of the skull, and further reach the inside of a fluid-filled part of the body, such as a ventricle 603.

[0044]

[0059] In one embodiment, the anchor device 606 is configured to stabilize the catheter stylet system 104, for example, by stabilizing the ultrasound tip to ensure that ultrasound data is acquired from the same position. The anchor device 606 may include a pin, a spiral, or other commonly used neurosurgical hardware, a strap that can be wrapped around the patient's skull, and / or a deployable balloon for stabilization. For example, the shape of the deployable balloon device may be spherical or cylindrical and include a hollow cylindrical center through which the catheter stylet system 104 advances. The hollow cylindrical center may be lined with a plastic or metal cylinder, which may be reinforced with an inflatable membrane. The membrane inflates cylindrically and presses against the skull bone, allowing fixation of the catheter stylet system 104 in two directions, while still allowing advancement of the catheter stylet system 104 and limited bending of the device to search for the ventricles.

[0045]

[0060] By fixing the catheter stylet system 104, it can be facilitated to perform multidimensional reconstruction of images, as will be explained in more detail below. This makes it easier to understand the patient's neural structure in real time, to receive real-time feedback on the surgeon's trajectory, to obtain real-time distance from target information, to visualize ventricular size in real time, and, if necessary, to obtain information or data on how the surgeon adjusts their trajectory along the way.

[0046]

[0061] In one embodiment, the anchor device 606 may include transceivers 612, such as a phased array of A-mode and / or B-mode ultrasound transceivers, on the bottom portion of the anchor device 606. These ultrasound transceivers are also communicatively coupled to a computing device, for example, via a wire connection 612, and used to acquire ultrasound data. The ultrasound data can be used to generate multidimensional images of the body part into which the catheter stylet system 104 is inserted.

[0047]

[0062] In further embodiments, means may be provided to allow adjustment of catheter 202 insertion midway through its trajectory by enabling guidance or deflection of the catheter stylet system 104. This mid-trajectory adjustment means may include, but is not limited to, two wires. These wires are attached to the tip of the stylet 204, for example, running along the outer surface of the stylet 204, for example, through the gap between the inner surface of the catheter 202 and the outer surface of the stylet 204. For example, pulling one wire with an ergonomic handle shortens that wire relative to the other, thereby pulling or changing the direction of the catheter stylet system 104. Simply twisting the stylet 204 while it remains inserted in the body can address corrections to the current line of travel, i.e., any direction perpendicular to the trajectory. In other embodiments, the stylet 204 may have a braided shaft and a deflectable section. The deflectable section allows the stylet tip trajectory to be changed and corrected in multiple directions midway through its passage. By engaging the actuator with the handle or the proximal shaft of the stylet 204 axis, healthcare providers can make fine adjustments to their trajectory.

[0048]

[0063] Figure 6B shows one embodiment of a catheter stylet system 104 inserted into a body in accordance with the subject matter disclosed herein. In one embodiment, an anchor device 606 is inserted into an opening in the body 602, and the catheter stylet system 104 is inserted into the opening 610 of the anchor device 606 and further inserted into the body 602. The catheter stylet system 104 can then be moved or rotated in a conical direction 614 (for example, around an axis of rotation), thereby diffusing the ultrasonic signal 616 in multiple directions within the body 602. Furthermore, the catheter stylet system 104 can acquire positional data from a position sensor 310 and detect conical movement relative to a fixed point, for example, the tip of the catheter stylet system 104. In this way, ultrasonic data from multiple cross-sections of the body 602 can be acquired and used to generate multidimensional images or graphics. This can be done in real time in response to the detection of a change in the position of the catheter stylet system 104.

[0049]

[0064] Figure 6C shows one embodiment of output using the catheter stylet system 104 according to the subject disclosed herein. In one embodiment, the catheter stylet system 104 can acquire and transmit an A-mode ultrasound signal that generates a 1D output signal 620 shown in Figure 6C. As will be described in more detail below, the 1D output signal 620 can be used to determine the type, material, etc. of tissue (for example, based on the amplitude of the 1D output signal 620), and the catheter stylet system 104 can be moved in a cone-like motion into the body while a corresponding 3D graphical image 622 is generated in real time, thereby performing a 3D reconstruction of the part of the body into which the catheter stylet system 104 is inserted, for example, the brain.

[0050]

[0065] Figure 7 shows one embodiment of an apparatus 700 for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein. In one embodiment, the apparatus 700 includes an instance of an imaging device 110. In one embodiment, the imaging device 110 includes a signal processing module 702, a graphics generation module 704, a presentation module 706, a routing module 708, and an AI module 710. These are described in more detail below. In one embodiment, the imaging device 110 may be located on a computing device 102, on a server 112 (for example, to hand over processing to a data center), and / or a combination thereof.

[0051]

[0066] In one embodiment, the signal processing module 702 is configured to receive signals from the ultrasonic transceiver 306 of the catheter stylet system 104. In such an embodiment, the ultrasonic transceiver 306 transmits an ultrasonic signal or ultrasound and receives the returning echo, echo signal, or echo wave, and transmits information related to the echo signal or echo wave to the computing device 102 via a wired 106 or wireless 108 connection.

[0052]

[0067] In one embodiment, the signal processing module 702 can cause the ultrasonic transceiver 306 to continuously transmit and receive ultrasonic signals at periodic intervals, for example, every second, every half second, etc. In yet another embodiment, the signal processing module 702 can dynamically determine the rate at which ultrasonic signals are transmitted and received, for example, during a procedure in response to the movement of the catheter stylet system 104 (based on input from the position sensor 310), based on feedback from the AI ​​engine (described below), based on feedback from the received ultrasonic signals, in response to user input, and / or similarly.

[0053]

[0068] In one embodiment, the signal processing module 702 can determine a pulse pattern for the ultrasonic transmitter 306 to transmit and receive ultrasonic signals. This pulse pattern may include signal intensity, signal frequency, signal sequence (how often or at what intervals the signal is transmitted), and / or similar. The signal processing module 702 can dynamically determine the rate at which ultrasonic signals are transmitted and received, for example, during a procedure in response to the movement of the catheter stylet system 104 (based on input from the position sensor 310), based on feedback from the AI ​​engine (described below), based on feedback from the received ultrasonic signals, in response to user input, and / or similar.

[0054]

[0069] In one embodiment, the signal processing module 702 filters out noisy ultrasonic data or data that is not useful for generating multidimensional graphics from the received signal. Such data may include outlier data, data that cannot be visually plotted, signal data that is higher or lower than a threshold amplitude, and / or similar. In one embodiment, the signal processing module 702 may also use an AI engine to process the signal data, for example, a 1D output signal, to identify and remove noisy data.

[0055]

[0070] In one embodiment, the graphic generation module 704 is configured to generate a multidimensional graphic or image based on a signal received by the signal processing module 702. In such an embodiment, the multidimensional graphic may be a two-dimensional (2D) or three-dimensional (3D) graphic of the part of the body into which the catheter stylet system 104 is inserted. For example, when the catheter stylet system 104 is inserted into a patient's head and locates the ventricles via the brain, the signal processing module 702 can receive and process a 1D output signal from the A-mode ultrasound transceiver 306 in the catheter stylet system 104. Once the catheter stylet system 104 is placed in the user's head, the graphic generation module 704 uses this 1D output signal to generate a multidimensional graphic of the user's brain.

[0056]

[0071] In one embodiment, the graphic generation module 704 processes the output signal using various image processing algorithms to generate a multidimensional graphic. For example, the graphic generation module 704 uses a segmentation algorithm to identify edges, regions, and / or similar structures being imaged based on different characteristics of the output signal, such as different amplitudes, thresholds, values, etc. For instance, the graphic generation module 704 can use a segmentation algorithm to identify brain tissue, blood vessels, ventricles, and / or other materials, tissues, regions, etc., within the user's brain, and can include metadata or other additional information describing different areas, regions, structures, etc., of the body within the generated graphic.

[0057]

[0072] In one embodiment, the graphic generation module 704 generates a multidimensional graphic based on the change in the stylet's position according to the position data received from the position sensor 310. For example, as the catheter stylet system 104 is moved, for example, in a cone shape, the signal processing module 702 can receive and process new ultrasound signal data, which the graphic generation module 704 then uses to generate a multidimensional graphic. In such an embodiment, the graphic generation module 704 can update the multidimensional graphic in real time in response to the change in the position of the catheter stylet system 104.

[0058]

[0073] In one embodiment, the presentation module 706 is configured to display a multidimensional graphic on the display module 103. In such an embodiment, the presentation module 706 can display the multidimensional graphic, for example in real time during this procedure, as the multidimensional graphic is created and / or received from the graphic generation module 704, so that the presented graphic is continuously updated as new graphic data is provided from the graphic generation module 704.

[0059]

[0074] In one embodiment, the presentation module 706 is configured to visually highlight different parts or sections of the body having different properties, such as different tissue types, fluid types, materials, and / or similar characteristics. For example, the presentation module 706 can use metadata or other information within the multidimensional graphic data generated and provided by the graphic generation module 704 to visually highlight different areas, regions, structures, etc., of the body, for example, using different brightness levels, contours, shading, outlines, line widths, colors, gradients, patterns, labels, text, and / or similar characteristics.

[0060]

[0075] In one embodiment, the routing module 708 is configured to determine the optimal route to a target location inside the body. In such an embodiment, the routing module 708 can receive the position of the insertion point of the catheter stylet system 104 on the body relative to a predetermined, default, or similar known depiction of the body in which the catheter stylet system 104 is inserted. For example, on a graphical display, a user such as a doctor can select, point, click, tap, etc., on a depiction of the user's head in which the catheter stylet system 104 is inserted.

[0061]

[0076] Based on a reference point, the routing module 708 can determine the optimal route to the target point. The target point can be set by a physician (for example, by providing an input that identifies the target point), or it can be determined based on a previous scan of the user's body (for example, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan), based on an AI-generated depiction of the body, and / or based on other representational data describing the part of the body into which the catheter stylet system 104 is inserted.

[0062]

[0077] In such embodiments, the routing module 708 can determine the optimal route to the target point based on known information about the structure of the body part into which the catheter stylet system 104 is inserted between the insertion point and the target point, for example, between the opening 604 and the ventricle 603 as shown in Figures 6A and 6B. For example, the routing module 708 can determine the optimal route through the user's brain from the drilling opening to the target ventricle by referring to known structural elements, materials, tissues, or other components within the user's brain. Known structural elements may include structural elements that are typically present in the human brain, and the routing module 708 can determine this from user input, from external sources (e.g., health websites, medical handbooks, etc.), from AI-generated information about the human brain, and / or similar sources. The optimal route may include the best route through parts of the body that cause minimal destruction, injury, interference, pain, etc., for example, the best route that avoids blood vessels, tissues, or other structures.

[0063]

[0078] In one embodiment, the path module 708 can further determine the trajectory of the catheter stylet system 104 relative to the target position, for example, based on position sensor data from the position sensor 310, and issue commands to move the catheter stylet system 104 along the optimal path. In other words, the path module 708 can determine whether the catheter stylet system 104 is on a trajectory that deviates from the optimal path, and if so, can issue feedback, commands, instructions, etc., to move the catheter stylet system 104 back to the optimal path. For example, while inserting the catheter stylet system 104 and moving it toward the target position, the path module 708 can provide audible or visual feedback (e.g., move 2 mm up, move back, move 4 mm forward, etc.) and give commands to move the catheter stylet system 104 to move as close to the optimal path as possible. In one embodiment, deviations from the optimal path (drift away) can be approximated by using vector addition or real-time imaging signal feedback on a 3D rendering graphic.

[0064]

[0079] In one embodiment, the presentation module 706 displays the target position, optimal path, and trajectory of the catheter stylet system 104 on the display device 103. In such an embodiment, the presentation module 706 displays the target position, optimal path, and trajectory of the catheter stylet system 104 as overlays on a multidimensional graphic of the body, visually representing each with different colors, patterns, brightness, etc. Furthermore, the presentation module 706 can also display commands, instructions, measurements, etc., to move the catheter stylet system 104 so that it remains on the optimal path.

[0065]

[0080] For example, the presentation module 706 can display a red / green light target image / trajectory system on the screen to help the surgeon advance the catheter along the correct line. The green light target icon indicates to the surgeon that the catheter stylet system 104 is on the correct line / optimal path to penetrate the ventricle. The target trajectory can turn red once the trajectory deviates from the optimal path, indicating to the surgeon that trajectory correction is needed for interception of the ventricular cavity.

[0066]

[0081] In one embodiment, the AI ​​module 710 is configured to use an AI engine to determine various pieces of information related to the placement of the catheter stylet system 104. As used herein, AI is broadly defined as a branch of computer science dealing with the automation of intelligent behavior. AI systems can be designed to use machines to emulate and simulate human intelligence and corresponding behavior. This can take many forms, including symbolic AI, i.e., symbol manipulation AI. AI can deal with the analysis of abstract symbols and / or symbols that can be read by humans. AI can form abstract connections between data or other information or stimuli. AI can form logical conclusions. AI is intelligence exhibited by a machine, program, or software. AI is defined as the study and design of intelligent agents, where an intelligent agent is a system that perceives its environment and takes actions that maximize its probability of success.

[0067]

[0082] AI can possess various attributes such as reasoning, logical thinking, and problem-solving. AI can include knowledge representation or learning. AI systems can perform natural language processing, cognition, motion detection, and information manipulation. The higher the level of abstraction, the greater the social intelligence, creativity, and holistic intelligence that can be achieved. Various methods are employed, including cybernetics and brain simulation, symbolic, subsymbolic, and statistical methods, as well as integrations of these techniques.

[0068]

[0083] Various AI tools can be employed individually or in combination. These tools may include search and optimization, logical and probabilistic methods for uncertain logical thinking, classifiers and statistical learning methods, neural networks, deep feedforward neural networks, deep recurrent neural networks, deep learning, control theory, and language.

[0069]

[0084] In one embodiment, the AI ​​engine may include a generative AI engine. As used herein, generative AI is a type of AI capable of creating new content such as text, images, music, audio, and video. Generative AI systems are often used to form synthetic data, which can be used to train machine learning models and validate mathematical models. In such embodiments, the generative AI engine may be prompted to generate content. For example, as used herein, the AI ​​module 710 may prompt, "Generate a 3D image of an average human brain," "Generate maps of different ventricles on a human brain," "Generate pathways from the skull to the ventricles in a human brain," and so on.

[0070]

[0085] In such embodiments, the AI ​​module 710 can train its AI engine on subject-specific data, such as surface brain morphology or other structure-related data from various patients (e.g., MRI scan data, CT scan data, images, videos, text, etc., describing or indicating structural elements for multiple patients). Furthermore, the AI ​​module 710 can also train its AI engine on ultrasound data relating to different structures, so as to identify patterns in ultrasound signals associated with different structural elements such as tissue, fluid, ventricles, blood vessels, bone, etc.

[0071]

[0086] Therefore, users can customize the AI ​​engine to suit specific applications and use it to determine things like the optimal pulse pattern for ultrasound signals, the optimal stylet tip design for specific parts of the body, structural components identified in 1D signals (e.g., segmentation analysis), signal processing (e.g., to remove noise from signal data), optimal path / trajectory analysis, and / or similar. Furthermore, the AI ​​engine can also be used to assist in generating multidimensional images using output signal data by training the AI ​​engine to process the signal data and generate a graphic image of this signal data.

[0072]

[0087] Figure 8 shows one embodiment of Method 800 for an ultrasound-equipped catheter stylet system according to the subject disclosed herein. In one embodiment, Method 800 is performed by a computing device 102, a server 112, a catheter stylet system 104, an imaging device 104, a signal processing module 702, a graphics generation module 704, a presentation module 706, a routing module 708, an AI module 710, or a combination thereof.

[0073]

[0088] In one embodiment, when method 800 starts, it receives a signal from an ultrasonic transceiver 306 (802), generates a multidimensional graphic based on the received signal (804), presents this multidimensional graphic on a display device 103 (806), and then method 800 ends.

[0074]

[0089] Figure 9 shows one embodiment of Method 900 for an ultrasound-equipped catheter stylet system according to the subject disclosed herein. In one embodiment, Method 900 is performed by a computing device 102, a server 112, a catheter stylet system 104, an imaging device 104, a signal processing module 702, a graphics generation module 704, a presentation module 706, a routing module 708, an AI module 710, or a combination thereof.

[0075]

[0090] In one embodiment, when method 900 starts, it receives a signal from the ultrasonic transceiver 306 (902) and generates a multidimensional graphic based on the received signal (904). In one embodiment, method 900 determines the optimal path to a target location inside the body (906).

[0076]

[0091] In one embodiment, method 900 presents a multidimensional graphic on a display device 103 (908). In one embodiment, method 900 determines the trajectory of the catheter stylet system 104 with respect to a target position (910) and issues a command to move the catheter stylet system 104 along this optimal path. In one embodiment, method 900 updates the multidimensional graphic in real time in response to changes in the position of the stylet (912), and then method 900 terminates.

[0077]

[0092] Figure 10 shows one embodiment of Method 1000 for an ultrasound-equipped catheter stylet system according to the subject matter disclosed herein. In one embodiment, Method 1000 is performed by a computing device 102, a server 112, a catheter stylet system 104, an imaging device 104, a signal processing module 702, a graphics generation module 704, a presentation module 706, a routing module 708, an AI module 710, or a combination thereof.

[0078]

[0093] In one embodiment, when method 1000 is started, a stylet 204 is inserted into the catheter 202 (10002), the catheter 202 is inserted into the body (1004), an ultrasonic transceiver 306 inside the stylet 204 is made to generate an ultrasonic signal (1006), the stylet 204 is moved in a cone shape while the catheter 202 is inserted into the body (1008), position data is received from a position sensor 310 inside the stylet 204 while moving the stylet 204, and signal data is also received from the ultrasonic transceiver 306 (1010), a multidimensional graphic of the part of the body into which the catheter 202 is inserted is generated based on the position data and signal data (1012), and then method 1000 is terminated.

[0079]

[0094] Apparatus for an ultrasound-equipped catheter stylet system is disclosed. The system and method perform the functions of this apparatus. In one embodiment, the apparatus includes a catheter and a stylet configured to be inserted into the catheter. In one embodiment, the stylet includes a shaft having a first end and a second end, and an ultrasonic transceiver coupled to the first end of the shaft, the ultrasonic transceiver configured to transmit and receive ultrasonic signals.

[0080]

[0095] In one embodiment, the shaft of the stylet has at least one channel along its length, and when the stylet is inserted into the catheter, this channel forms at least one gap between the catheter and the shaft. In one embodiment, the shaft of the stylet has a shape different from the internal shape of the catheter so that when the stylet is inserted into the catheter, a gap is introduced between the shaft and the catheter.

[0081]

[0096] In one embodiment, the catheter is equipped with a low-intensity tip, and a stylet is inserted into the catheter so that an ultrasonic transceiver is close to this low-intensity tip. In one embodiment, the low-intensity tip has a configuration for filtering or focusing the ultrasonic signal. This configuration includes the shape of the low-intensity tip, the size of the low-intensity tip, the thickness of the low-intensity tip, the presence of a cavity inside the low-intensity tip, or a combination thereof.

[0082]

[0097] In one embodiment, the ultrasonic transceiver has a concave shape to focus the ultrasonic signal. In one embodiment, the ultrasonic transceiver is detachable from the shaft before the stylet is removed from the catheter.

[0083]

[0098] In one embodiment, the stylet further includes a position sensor for detecting the stylet's position relative to a fixed point. In one embodiment, the ultrasonic transceiver is configured to transmit and receive A-mode ultrasonic signals.

[0084]

[0099] In one embodiment, the system includes a catheter and a stylet to be inserted into the catheter. In one embodiment, the stylet includes an axis having a first end and a second end, an ultrasonic transceiver coupled to the first end of the axis and configured to transmit and receive ultrasonic signals, and a position sensor for detecting the position of the stylet relative to a fixed point. In one embodiment, the system is configured to receive signals from the ultrasonic transceiver, generate a multidimensional graphic based on the received signals, and present the multidimensional graphic on a display device.

[0085]

[0100] In one embodiment, the system is configured to generate a multidimensional graphic based on the change in the stylet's position according to position data received from a position sensor.

[0086]

[0101] In one embodiment, the system is configured to update a multidimensional graphic in real time in response to a change in the position of the stylet. In one embodiment, the multidimensional graphic constitutes a multidimensional graphic of the part of the body into which the catheter is inserted.

[0087]

[0102] In one embodiment, the system is configured to determine the optimal path to a target location inside the body. In another embodiment, the system is configured to determine the trajectory of the catheter relative to the target location and issue a command to move the catheter along the optimal path.

[0088]

[0103] In one embodiment, the system is configured to display the target position, optimal path, and catheter trajectory on a display device, superimposed on a multidimensional graphic of the body. In another embodiment, the system is configured to visually highlight different parts of the body having different properties based on signals received from an ultrasound transceiver.

[0089]

[0104] In one embodiment, the system is configured to use an artificial intelligence engine to determine an optimal pulse pattern for an ultrasonic signal. In one embodiment, the system includes an anchor device configured to stabilize the catheter at the insertion point when the catheter is inserted into a part of the body.

[0090]

[0105] In one embodiment, the method involves inserting a stylet into a catheter, inserting the catheter into the body, generating an ultrasonic signal with an ultrasonic transceiver, moving the stylet in a cone shape while inserting the catheter into the body, receiving position data from a position sensor while moving the stylet, and further receiving signal data from the ultrasonic transceiver, and generating a multidimensional graphic of the part of the body into which the catheter is inserted based on the position data and signal data.

[0091]

[0106] Throughout this specification, whenever the terms “one embodiment,” “an embodiment,” or similar wording are used, it means that any particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. In other words, throughout this specification, whenever the phrases “in one embodiment,” “in an embodiment,” or similar wording appear, they refer to the same embodiment, but unless otherwise expressly specified, they may mean “one or more embodiments, but not all embodiments,” though not necessarily so. The terms “including,” “comprising,” “having,” and variations thereof, unless otherwise expressly specified, mean “including, but not limited to.” Lists of items do not imply that any or all of these items are mutually exclusive and / or mutually inclusive, unless otherwise expressly specified. The terms “a,” “an,” and “the” also mean “one or more,” unless otherwise expressly specified.

[0092]

[0107] Furthermore, the features, advantages, and characteristics of the embodiments described can be combined in any suitable manner. Those skilled in the art will acknowledge that the embodiments can be practiced even without one or more of the specific features or advantages of a particular embodiment. In other examples, additional features and advantages may not be present in all embodiments, but may be present in specific embodiments.

[0093]

[0108] These features and advantages of the embodiments will become more apparent from the following description and the appended claims, or can be learned through the practice of the embodiments as expressed below. As will be recognized to those skilled in the art, aspects of the invention can be embodied as systems, methods, and / or computer program products. Thus, aspects of the invention can take the form of hardware embodiments as a whole, software embodiments as a whole (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware embodiments, all of which may collectively be referred to herein as “circuits,” “modules,” or “systems.” Furthermore, aspects of the invention can also take the form of computer program products embodied in one or more computer-readable media on which the program code is embodied.

[0094]

[0109] Many of the functional units described herein are designated as modules to particularly emphasize their implementation independence. For example, modules can be implemented as hardware circuits, including custom-made very large-scale integrated circuits ("VLSI") or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components. Modules can also be implemented within programmable hardware devices, such as field-programmable gate arrays ("FPGA"), programmable array logic, and programmable logic devices.

[0095]

[0110] Furthermore, modules can be implemented as software adapted for execution on various types of processors. Modules, which are identified with program code, can, for example, constitute one or more physical or logical blocks of computer instructions, which can be organized as objects, procedures, or functions. However, the executable files of identified modules do not need to be physically located together; they can contain entirely different instructions stored in different locations. When these are logically combined, they constitute the module and achieve its stated purpose.

[0096]

[0111] In fact, a module of program code can be one instruction or many instructions, and can be distributed across various different code segments, between different programs, and even across various memory devices. Similarly, operational data can be identified and represented within a module, materialized in any suitable form, and organized within any suitable type of data structure. Operational data can be collected as a single data set, distributed across different locations including different storage devices, or even exist, at least partially, simply as electronic signals on a system or network. If a module or part of a module is implemented in software, the program code can also be stored and / or propagated on one or more computer-readable media.

[0097]

[0112] A computer program product may include a computer-readable storage medium (or a set of mediums) having computer-readable program instructions for causing a processor to execute an aspect of the present invention.

[0098]

[0113] Computer-readable storage media can be tangible devices capable of holding and storing instructions for use by instruction-executing devices. Computer-readable storage media may be, but are not limited to, electronic storage devices, magnetic storage devices, optical storage devices, electromagnetic storage devices, semiconductor storage devices, or any suitable combination thereof. A non-exhaustive list of more specific examples of computer-readable storage media includes: portable computer diskettes, hard disks, random-access memory ("RAM"), read-only memory ("ROM"), erasable programmable read-only memory ("EPROM") or flash memory, static random-access memory ("SRAM"), portable compact disk read-only memory ("CD-ROM"), digital versatile disks ("DVD"), memory sticks, floppy disks, mechanical encoding devices such as punch cards or raised structures in grooves on which instructions are recorded, and any suitable combination thereof. When used herein, computer-readable storage media should not be construed as transient signals themselves, such as radio waves or other free-propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other permeable media (e.g., light pulses passing through optical fiber cables), or electrical signals transmitted through wires.

[0099]

[0114] The computer-readable program instructions described herein can be downloaded from a computer-readable storage medium to each computing / processing device, or to an external computer or external storage device via a network, such as the Internet, a local area network, a wide area network, and / or a wireless network. The network may include copper transmission cables, optical transmission fibers, wireless transmitters, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computing / processing device receives the computer-readable program instructions from the network and transfers them for storage on a computer-readable storage medium located inside the respective computing / processing device.

[0100]

[0115] Computer-readable program instructions for performing the operations of the present invention may be assembler instructions, instruction-set-architecture ("ISA") instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state-setting data, or source code or object code written in any combination of one or more programming languages. Programming languages ​​include object-oriented programming languages ​​such as Smalltalk and C++, and traditional procedural programming languages ​​such as the "C" programming language or similar languages. Computer-readable program instructions can be executed entirely on the user's computer, partially as a standalone software package on the user's computer, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer can be connected to the user's computer via any type of network. Networks include local area networks ("LANs") or wide area networks ("WANs"). Alternatively, a connection to an external computer may be made (for example, via the Internet using an Internet service provider). In one embodiment, for example, an electronic circuit including a programmable logic circuit, a field-programmable gate array ("FPGA"), or a programmable logic array ("PLA") may be individually optimized to execute computer-readable program instructions and perform aspects of the present invention by utilizing state information of computer-readable program instructions.

[0101]

[0116] This specification describes aspects of the present invention with reference to flowcharts and / or block diagrams of methods, apparatuses (systems), and computer program products according to embodiments of the present invention. It will be understood that each block in the flowcharts and / or block diagrams, as well as combinations of blocks in the flowcharts and / or block diagrams, can be implemented by computer-readable program instructions.

[0102]

[0117] These computer-readable program instructions are supplied to the processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device. When these instructions are executed by the processor of the computer or other programmable data processing device, they can generate a machine that creates means to realize one or more functions / acts specified in one or more blocks of a flowchart and / or block diagram. These computer-readable program instructions can also be stored in a computer-readable storage medium, which can then instruct computers, programmable data processing devices, and / or other devices to function in a specific manner. The computer-readable storage medium containing the instructions then constitutes a product containing instructions that realize the modes of functions / acts specified in one or more blocks of a flowchart and / or block diagram.

[0103]

[0118] Furthermore, by loading computer-readable program instructions onto a computer, other programmable data processing device, or other device, and having a series of operational steps executed on that computer, other programmable device, or other device, a computer implementation process can be generated such that the instructions executed on the computer, other programmable device, or other device implement functions / acts specified within one or more blocks of a flowchart and / or block diagram.

[0104]

[0119] Many of the functional units described herein are designated as modules to particularly emphasize their implementation independence. For example, modules can be implemented as hardware circuits including custom VLSI circuits or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components. Modules can also be implemented within programmable hardware devices such as field-programmable gate arrays, programmable array logic, and programmable logic devices.

[0105]

[0120] Furthermore, modules can be implemented in software adapted for execution on various types of processors. Modules, which are identified with program instructions, can, for example, constitute one or more physical or logical blocks of computer instructions, which can be organized as objects, procedures, or functions. However, the executable files of identified modules do not need to be physically located together; they can contain entirely different instructions stored in different locations, and when logically combined, they constitute the module and achieve its stated purpose.

[0106]

[0121] The schematic flowcharts and / or schematic block diagrams in the drawings illustrate the architecture, function, and operation of possible embodiments of the apparatus, system, method, and computer program product according to various embodiments of the present invention. In this regard, each block in the schematic flowcharts and / or schematic block diagrams may represent a module, segment, or portion of code and constitute one or more executable instructions of program code for implementing a specified logical function(s).

[0107]

[0122] It should also be noted that in some alternative embodiments, the functions described within a block may be performed in a different order than that shown in the diagram. For example, two blocks shown consecutively may actually be executed substantially simultaneously, or these blocks may sometimes be executed in reverse order depending on the functions involved. Other steps and methods that are equivalent in function, logic, or effect to one or more blocks or parts thereof in the illustrated diagram can also be recalled.

[0108]

[0123] Various arrow shapes and line types may be used in flowcharts and / or block diagrams, but these should not be interpreted as limiting the scope of the corresponding embodiment. In fact, some arrows or other connectors may be used only to indicate the logical flow of the illustrated embodiment. For example, some arrows may indicate a waiting or monitoring period of an unspecified length between the listed steps of the illustrated embodiment. It should also be noted that each block in a block diagram and / or flowchart, as well as combinations of blocks in a block diagram and / or flowchart, can be implemented by a special-purpose hardware-based system that performs a specified function or act, or a combination of special-purpose hardware and program code.

[0109]

[0124] As used herein, a list using the conjunction "and / or" includes any one item in the list, or any combination of items in the list. For example, the list A, B, and / or C includes A only, B only, C only, a combination of A and B, a combination of B and C, a combination of A and C, or a combination of A, B, and C. As used herein, a list using the term "one or more of" includes any one item in the list, or any combination of items in the list. For example, one or more of A, B, and C includes A only, B only, C only, a combination of A and B, a combination of B and C, a combination of A and C, or a combination of A, B, and C. As used herein, a list using the term "one of" includes only one of any one item in the list. For example, “one of A, B, and C” includes A only, B only, or C only, and excludes combinations of A, B, and C. As used herein, “a member selected from the group consisting of A, B, and C” includes only one A, B, or C, and excludes combinations of A, B, and C. As used herein, “a member selected from the group consisting of A, B, and C and combinations thereof” includes A only, B only, C only, a combination of A and B, a combination of B and C, a combination of A and C, or a combination of A, B, and C.

[0110]

[0125] The present invention can be embodied in other specific forms without departing from its spirit or essential features. The embodiments described are to be considered illustrative rather than limiting in all respects. The scope of the present invention is therefore indicated by the appended claims rather than by the foregoing description. All modifications that fall within the meaning and scope of the claims are to be encompassed within that scope.

Claims

1. It is a device, Catheter and, A stylet configured to be inserted into the catheter, A shaft having a first end and a second end, An ultrasonic transceiver coupled to the first end of the shaft, configured to transmit and receive ultrasonic signals, A stylet equipped with, A device equipped with the following features.

2. The apparatus according to claim 1, wherein the shaft of the stylet has at least one flow path along the length of the shaft, and when the stylet is inserted into the catheter, it forms at least one gap between the catheter and the shaft.

3. The apparatus according to claim 1, wherein the shaft of the stylet has a shape different from the internal shape of the catheter so that a gap is introduced between the shaft and the catheter when the stylet is inserted into the catheter.

4. The apparatus according to claim 1, wherein the catheter has a low-luminosity tip, and the stylet is inserted into the catheter such that the ultrasonic transceiver is in close proximity to the low-luminosity tip.

5. The apparatus according to claim 4, wherein the low-luminance tip has a configuration for filtering or focusing the ultrasonic signal, and the configuration includes the shape of the low-luminance tip, the size of the low-luminance tip, the thickness of the low-luminance tip, the presence of a cavity within the low-luminance tip, or a combination thereof.

6. The apparatus according to claim 1, wherein the ultrasonic transceiver has a concave shape for focusing the ultrasonic signal.

7. The apparatus according to claim 1, wherein the ultrasonic transceiver is detachable from the shaft before the stylet is removed from the catheter.

8. The apparatus according to claim 1, wherein the stylet further comprises a position sensor for detecting the position of the stylet with respect to a fixed point.

9. The apparatus according to claim 1, wherein the ultrasonic transceiver is configured to transmit and receive A-mode ultrasonic signals.

10. It is a system, Catheter and, A stylet configured to be inserted into the catheter, A shaft having a first end and a second end, An ultrasonic transceiver coupled to the first end of the shaft, configured to transmit and receive ultrasonic signals, A position sensor that detects the position of the stylet relative to a fixed point, A stylet equipped with, Memory and A processor coupled with the memory and the stylet, Receiving a signal from the aforementioned ultrasonic transceiver, Based on the received signal, a multidimensional graphic is generated. A processor configured to display the aforementioned multidimensional graphics on a display device, A system equipped with these features.

11. The system according to claim 10, wherein the processor is configured to generate the multidimensional graphic based on the change in the position of the stylet according to the position data received from the position sensor.

12. The system according to claim 11, wherein the processor is configured to update the multidimensional graphics in real time in response to a change in the position of the stylet.

13. The system according to claim 10, wherein the multidimensional graphic includes a multidimensional graphic of a part of the body into which the catheter is inserted.

14. A system according to claim 13, wherein the processor is configured to determine the optimal path to a target location within the body.

15. The system according to claim 14, wherein the processor is configured to determine the trajectory of the catheter with respect to the target position and to issue a command to move the catheter along the optimal path.

16. The system according to claim 15, wherein the processor is configured to display the target position, the optimal path, and the trajectory of the catheter superimposed on a multidimensional graphic of the body on the display device.

17. The system according to claim 13, wherein the processor is configured to visually highlight different parts of the body having different properties based on signals received from the ultrasonic transceiver.

18. A system according to claim 10, wherein the processor is configured to use an artificial intelligence engine to determine an optimal pulse pattern for the ultrasonic signal.

19. A system according to claim 10, further comprising an anchor device configured to stabilize the catheter at an insertion point where the catheter is inserted into a part of the body.

20. It is a method, A step of inserting a stylet into a catheter, wherein the stylet is A shaft having a first end and a second end, An ultrasonic transceiver coupled to the first end of the shaft, configured to transmit and receive ultrasonic signals, A position sensor that detects the position of the stylet relative to a fixed point, It has steps, The steps include inserting the catheter into the body, The steps include: causing the ultrasonic transceiver to generate the ultrasonic signal; The steps include inserting the catheter into the body while moving the stylet in a cone-like motion, The steps include moving the stylet while receiving position data from the position sensor and receiving signal data from the ultrasonic transceiver, The steps include generating a multidimensional graphic of the part of the body into which the catheter is inserted, based on the position data and the signal data, Methods that include...

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