Systems and methods for portable ultrasound-guided cannulation

Abstract

A system and method for semi-automated, portable ultrasound-guided cannulation is provided. The system and method for image analysis enable segmentation of a vessel of interest from image data. The image analysis provides guidance for insertion of a cannulation system into a subject, allowing even inexperienced personnel to perform the insertion based on the provided guidance. The guidance can include indicators or mechanical guides that guide a user to insert the vascular cannulation system into the subject through the vessel of interest.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 888,059 (filed August 16, 2019, entitled "Semi-automated portable vascular cannulation system"), the entire contents of which are incorporated herein by reference as if set forth herein.

[0002] <Statement regarding federally sponsored research> This invention was made with government support under FA8702-15-D-0001 awarded by the United States Army and the Defense Health Agency. The government has certain rights in this invention. [Background technology]

[0003] Inserting a catheter into a blood vessel, vein, or artery can be a difficult task for inexperienced personnel or in trauma applications because the vein or artery may be located deep within the body, may be difficult to access in certain patients, or may be obscured by trauma to the surrounding area of ​​the vessel. Multiple penetration attempts can cause extreme discomfort to the patient, loss of valuable time in an emergency, and further trauma. Furthermore, central veins and arteries are often in close proximity to one another. For example, an attempt to access the internal jugular vein can result in puncturing the carotid artery instead of the internal jugular vein, which can increase the blood pressure of the blood flowing through the artery and lead to blood loss, resulting in serious complications or even death. Associated nerve pathways may also be in close proximity to vessels, such as the femoral nerve, which is located near the femoral artery, and puncturing such vessels can cause significant pain or loss of function for the patient.

[0004] To prevent complications during cannulation, ultrasonic instruments can be used to identify the location and direction of the vessel to be penetrated. One approach to such ultrasound-guided cannulation involves a human expert manually interpreting ultrasound images and inserting the needle. Such manual procedures can only be performed successfully by experts who perform the procedure regularly and who are able to accurately cannulate the vessel.

[0005] In an attempt to eliminate or reduce the burden placed on professionals, systems have been developed, such as robotic systems that use robotic arms to insert needles. Such tabletop systems and robotic arms are too large for portability and may not be available to medical personnel at the time of injury. Moreover, the above-mentioned systems are limited to peripheral venous access and may not be usable to cannulate more difficult vessels or veins.

[0006] Additionally, systems have been used to display image overlays on the skin to indicate where vessels may be located or to highlight where peripheral veins are located just below the surface, but these systems, like those mentioned above, are limited to peripheral veins and do not provide depth information that an inexperienced person can use to guide cannulation, which of course introduces errors and difficulties that can lead to improper registration.

[0007] Therefore, there is a need for improved techniques for cannulating blood vessels that are less cumbersome, more accurate, and can be used by less experienced personnel. Summary of the Invention

[0008] The present disclosure addresses the above-mentioned shortcomings by providing a novel system and method for guided vascular cannulation. The system and method provide image analysis for segmenting a vessel of interest from image data. The image analysis provides guidance for inserting a cannulation system into a subject, which can be performed by an inexperienced person based on the provided guidance. The guidance can include indicators or mechanical guides to guide a user in inserting the vascular cannulation system into the subject through the vessel of interest.

[0009] In one configuration, a system for guiding an invasive device during an invasive treatment of a subject is provided. The system includes an ultrasound probe and a guidance system fixedly coupled to the ultrasound probe, the guidance system configured to guide the invasive device within a field of view (FOV) of the ultrasound probe. The system also includes a non-transitory memory storing instructions and a processor configured to access the non-transitory memory to execute the instructions, whereby the processor accesses image data acquired of the subject using the ultrasound probe, the image data including a location of the target structure in the subject, determines an insertion point location for the invasive device based on the location of the target structure, guides placement of the ultrasound probe to position the guidance system at the insertion point location, and tracks the invasive device from the insertion point location to the target structure.

[0010] In another configuration, a system for guiding an invasive device during an invasive treatment of a subject is provided. The system includes a computer system that accesses image data acquired from the subject using an ultrasound probe, the image data including at least one image of a target structure of the subject, identifies a location of the target structure in the subject from the image data, determines an insertion point location for the invasive device based on the location of the target structure, and guides placement of the ultrasound probe to position the guidance system at the insertion point location. The system also includes an ultrasound probe and a guidance system fixedly coupled to the ultrasound probe, the guidance system configured to receive and guide the invasive device within a field of view (FOV) of the ultrasound probe. The system also includes a display configured to guide the invasive device from the insertion point location to the target structure.

[0011] The foregoing and other aspects and advantages of the present disclosure will become apparent from the following description. The following description is written with reference to the accompanying drawings, which form a part of the following description and illustrate preferred embodiments. However, the preferred embodiments do not necessarily encompass the entire scope of the present invention, and the claims should be considered in interpreting the scope of the present invention. In the following description, like reference numerals are used to refer to like parts among the drawings. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic diagram of an example, non-limiting ultrasound system in which the systems and methods described in this disclosure may be implemented. [Figure 2] FIG. 1 is a schematic diagram of one non-limiting example configuration for guiding needle insertion into a vessel of interest using an ultrasound probe. [Figure 3] 1 is a flowchart of the steps of a non-limiting example method of operating a system for guiding vascular cannulation. [Figure 4A]10 is another flowchart of the steps of a non-limiting example of a method of operating a system for guiding vascular cannulation. [Figure 4B] 1 is a flowchart of the steps of a non-limiting example method for guiding needle penetration of a vessel of interest. [Figure 5] FIG. 1 is a block diagram of an example system in which a vessel of interest imaging processing system may be implemented to generate images of a vessel of interest using a hybrid of machine learning and mechanistic models, or to otherwise measure or predict the location of a vessel of interest. [Figure 6] FIG. 6 is a block diagram of example hardware components of the system of FIG. 5. [Figure 7A] FIG. 1 is a perspective view of a non-limiting example invasive device guide coupled to an ultrasound probe. [Figure 7B] FIG. 7B is a side view of the invasive device guide of FIG. 7A. [Figure 7C] FIG. 7C is a side view of a base and ultrasound probe fixture for the invasive device guide of FIG. 7B. [Figure 7D] FIG. 7C is a cross-sectional view of a non-limiting example cartridge that fits into the injection assembly of FIG. 7B. [Figure 8A] FIG. 1 is a perspective view of a non-limiting example invasive device guide integrated with an ultrasound probe. [Figure 8B] FIG. 8B is an exploded view of the integrated invasive device guide and ultrasound probe of FIG. 8A. [Figure 9A] FIG. 1 is a perspective view of a non-limiting example cricothyrotomy cartridge for use in the present disclosure. [Figure 10A] FIG. 10 is a side view of a non-limiting example of the insertion of an expandable element into an invasive device guide. [Figure 10B] FIG. 10 is a side view illustrating the alignment of a non-limiting example expansion element with an invasive device guide and the advancement of a needle to guide the non-limiting example expansion element into a treatment target. [Figure 10C] FIG. 10 is a side view of advancing a non-limiting example dilating element over a needle into a treatment target. [Figure 10D]FIG. 10 is a side view of retracting the needle, leaving a non-limiting example dilating element within the treatment area. [Figure 10E] FIG. 10 is a side view of the removal of the invasive device guide, leaving behind a non-limiting example of an expandable element at the treatment site. DETAILED DESCRIPTION OF THE INVENTION

[0013] 1 illustrates an example of an ultrasound system 1300 in which the methods of the present disclosure can be implemented. The ultrasound system 100 includes a transducer array 102 having a plurality of separately driven transducer elements 104. The transducer array 102 may include any suitable ultrasound transducer array, including a linear array, a curved array, a phased array, etc. The transducer array 102 may also include a 1D transducer, a 1.5D transducer, a 1.75D transducer, a 2D transducer, a 3D transducer, etc.

[0014] When energized by the transmitter 106, a particular transducer element 104 generates a burst of ultrasonic energy. Ultrasonic energy (e.g., echoes) reflected from the study or treatment object back to the transducer array 102 is converted by each transducer element 104 into an electrical signal (e.g., an echo signal) that can be applied separately to a receiver 108 by a set of switches 110. The transmitter 106, receiver 108, and switches 110 operate under the control of a controller 112, which can include one or more processors. By way of example, the controller 112 can include a computer system.

[0015] The transmitter 106 can be programmed to transmit unfocused or focused ultrasound. In some configurations, the transmitter 106 can also be programmed to transmit diverging waves, spherical waves, cylindrical waves, plane waves, or combinations thereof. The transmitter 106 can also be programmed to transmit spatially or temporally encoded pulses.

[0016] The receiver 108 can be programmed to implement an appropriate detection sequence for the imaging task at hand, which in some embodiments can include one or more of line-by-line scanning, synthetic plane wave imaging, synthetic aperture imaging, and synthetic divergent beam imaging.

[0017] In some configurations, the transmitter 106 and receiver 108 can be programmed to achieve high frame rates, for example, frame rates corresponding to an acquisition pulse repetition frequency (PRF) of at least 100 Hz. In some configurations, the ultrasound system 100 can sample and store at least 100 ensembles of echo signals in the time direction.

[0018] The controller 112 can be programmed to perform the imaging sequence using techniques described in this disclosure or in other manners known in the art, hi some embodiments, the controller 112 receives user input that defines various factors used in the design of the imaging sequence.

[0019] A scan can be performed by setting each switch 110 to its transmit position during one transmit process according to the imaging sequence being performed and turning on the transmitter 1306 to energize the transducer elements 104. The switches 110 are then set to the receive position and successive echo signals generated by the transducer elements 104 in response to one or more detected echoes are measured and applied to the receiver 108. The separate echo signals from each transducer element 104 can be combined into one echo signal in the receiver 108.

[0020] The echo signals are sent to a processing unit 114 for processing, or images generated from the echo signals are processed. The processing unit 1314 may be embodied with a hardware processor and memory. As an example, the processing unit 1314 may use the methods disclosed herein to guide cannulation of a vessel of interest. The images generated from the echo signals by the processing unit 114 may be displayed on a display system 116.

[0021] In some configurations, the non-limiting example method can be applied to an imaging system, such as a commercially available imaging system, to provide a portable ultrasound system with vascular cannulation guidance. This method can identify the location of a vessel of interest, such as a vein or artery, as a user or medical professional moves the ultrasound probe. The system and method can provide real-time guidance to the user to position the ultrasound probe at the optimal needle insertion point. The probe can include one or more of a fixed needle guidance device, an adjustable mechanical needle guidance, a display image needle guidance, etc. The adjustable guidance can have an adjustable angle and / or depth. The system can guide or communicate the placement or adjustment of the needle guidance. The system can also regulate the needle insertion distance based on the calculated depth of the vessel of interest. The user can then insert the needle via a mechanical guidance attached to the probe or via a guidance display projected from the probe to ensure proper insertion. During needle insertion, the system can proceed to track the target vessel and the needle until it penetrates the vessel. A graphic user interface can be used to allow the medical practitioner to identify the desired vessel and to provide feedback to the medical practitioner throughout the process.

[0022] In this disclosure and the appended claims, the term "real-time" or related terms refer to and are defined as the real-time performance of a system, understood as performance based on an operational time limit from the occurrence of a particular event to the system's response to that event. For example, real-time extraction of data based on acquired ultrasound data and / or real-time display of such data may be triggered and / or performed simultaneously with or without interruption of the signal acquisition process.

[0023] In some configurations, the system can automate all ultrasound image interpretation and insertion calculations, while steps requiring dexterity such as moving the probe and inserting the needle can be performed by a medical professional or user. This division of labor avoids the use of dexterous robotic arms and results in a compact system that incorporates any necessary medical technology.

[0024] 2 is a schematic diagram illustrating a non-limiting example embodiment for guiding needle insertion into a femoral artery 230 or a femoral vein 240. An ultrasound probe 21 is used to acquire an image 220 of a region of interest including portions of the femoral artery 230, the femoral vein 240, and other objects of interest, such as a femoral nerve 250. The locations of the femoral artery 230, the femoral vein 240, and the femoral nerve 250 can be annotated on the image 220. As shown, a mechanical needle guide 260 can be provided to guide a needle 270 through a vessel of interest, such as the femoral vein 240. In some configurations, a visual needle guide 265 can be provided that projects a penetration guide image 266 onto the surface of the treatment object to guide the needle 270 through a vessel of interest, such as the femoral artery 230, as shown. The penetration guide image 266, when projected onto the treatment object, can reflect the actual size or depth of the vessel of interest being penetrated, or can provide a measurement or other indicator, such as a point target being penetrated.

[0025] The vessels of interest may include the femoral artery, femoral vein, jugular vein, peripheral veins, subclavian vein, and / or other vascular or non-vascular structures. Non-limiting applications include assisting medical personnel in performing additional emergency needle insertion procedures, such as needle decompression for tension pneumothorax (collapsed lung) and needle cricothyrotomy (to establish airway access). Portable ultrasound can be used to detect tension pneumothorax and needle insertion points (intercostal space, between ribs), as well as to detect the cricothyroid membrane and needle insertion points.

[0026] Referring to FIG. 3 , a flowchart of the steps of a non-limiting example method for operating a system for guiding vascular cannulation is presented. In step 310, imaging data is accessed. This can be done by performing an image acquisition and / or by accessing pre-acquired image data. The imaging data can include ultrasound data and / or any other form of medical imaging data, such as magnetic resonance imaging (MRI), computed tomography (CT), PET, SPECT, fluoroscopy, etc. In step 320, a vessel of interest can be identified using the imaging data. The location can be identified by segmenting the vessel of interest in the imaging data. The vessel of interest can include the femoral artery, femoral vein, jugular vein, peripheral veins, subclavian vein, etc. Thereafter, in step 330, an insertion point for the vascular cannulation system can be determined. The insertion point can be determined based on the identified location of the vessel of interest and a calculation of the depth and path that the cannulation system can pass from the surface of the treatment object to the vessel of interest without penetrating other organs of interest, such as nerves. In step 340, the insertion point can be determined for the user. The insertion point can be identified by illuminating a portion of the surface of the subject, by adjusting a mechanical needle guide to an appropriate setting for the user, or the like. The depth of needle penetration can also be controlled by the setting or height of the mechanical guide. In step 350, the vascular cannulation system can be guided into the vessel of interest to penetrate the vessel. Guiding the vascular cannulation system can include acquiring images of the vascular cannulation system and the vessel of interest as the cannulation system is inserted into the subject and displaying these images to the user as they are tracked.

[0027] Referring to FIG. 4A , another flowchart describing a method for guiding vascular cannulation illustrates steps in one non-limiting example. In step 410, the system identifies that a target location for placing an ultrasound transducer has been reached. In step 420, ultrasound imaging data is acquired from the target location. In step 430, a location of the vessel of interest is identified in the imaging data. In step 440, the vessel of interest is segmented in the ultrasound imaging data. A needle insertion point can then be determined in step 450. The insertion point determination can be based on the identification and segmented location of the vessel of interest. In some configurations, the method includes calculating the depth and path from the surface of the subject to the vessel of interest without the needle penetrating other organs or structures of interest, such as nerves, on the path from the surface of the subject to the vessel of interest. The insertion point can also be identified to the user in step 450. The insertion point may be identified, as described above, by illuminating a portion of the surface of the subject, ensuring that a fixed needle guide is positioned over the insertion point, automatically adjusting an adjustable mechanical needle guide to an appropriate setting for the user, etc. The depth of needle penetration may also be regulated by adjusting the setting of the adjustable mechanical guide or by a fixed height of the fixed guide. The needle may be tracked and guided into the vessel of interest so as to penetrate the vessel, step 460. Guiding the needle may include acquiring ultrasound images of the needle and the vessel of interest as the needle is inserted into the subject and displaying these images to the user as they are tracked.

[0028] Any ultrasound probe can be used in the present disclosure, including one-dimensional, two-dimensional, linear, phased array, etc. In some configurations, an image of the vessel of interest is overlaid on the image and displayed to the user with optional needle tracking information. In some configurations, no image is displayed to the user, and the insertion point can simply be identified by illuminating a portion of the surface to be treated. In some configurations, no image is displayed, and the user is simply notified that the probe has reached the appropriate location, whereupon the mechanical needle guidance automatically adjusts to the appropriate settings, such as angle and / or depth, to target the vessel of interest. Any suitable means, such as a light indicator, vibration of the probe, etc., can be used to notify the user that the probe has reached the appropriate location.

[0029] In some configurations, the system can automatically identify placement of the ultrasound transducer at the target location in step 410. Image data can be used to identify anatomical structures, such as the femoral triangle or neck, and the system can access the image data to provide automatic identification of where the ultrasound transducer is located. In some configurations, the user can specify a target vessel of interest, such as whether to target an artery or a vein. In one non-limiting example combination of the above configurations, the location of the ultrasound transducer in the treatment subject can be automatically identified in conjunction with imaging of the anatomical structures, with the user specifying a vessel of interest in the automatically identified anatomical structures. Minimal user input can be used, reducing the burden on the user's time.

[0030] The segmentation of the vessels of interest in step 440 can be based on machine learning of morphological and spatial information in the ultrasound image. In some configurations, a neural network can be used for machine learning, where the neural network can learn features at multiple spatial and temporal scales. The vessels of interest can be distinguished based on the shape and / or appearance of the vessel wall and / or the shape and / or appearance of the surrounding tissue, etc. In one non-limiting example, relatively hard walls and circular shapes can be used to distinguish arteries in the image, whereas oval shapes can be used to identify veins. The temporally trained routine can enable real-time vessel segmentation without the need for traditional post-hoc processing.

[0031] The segmentation of the vessel of interest in step 440 can use temporal information. The appearance and shape of a vessel can change over time with anatomical structure motion, such as changes with heartbeat or differences in appearance between hypotensive and normal tonic states. The machine learning routine can be trained using data from multiple time periods with anatomical structure differences reflected across multiple different time periods. A temporally trained machine learning routine can perform vessel segmentation for a treatment target in a time-robust manner without misclassification and without the need to find a specific time frame or specific probe location to identify the vessel of interest.

[0032] In some configurations, the system may include information checks to prevent any inconsistent misclassifications that may occur. The inconsistent information checks may include considering the overall anatomy at the probe's location. In one non-limiting example, if the system initially identifies two arteries at the probe's location, but the overall anatomy at that probe's location suggests that the results should return one artery and one vein instead of two arteries, the system will automatically correct to correctly identify one artery and one vein instead of the incorrect two arteries, preventing the misclassification.

[0033] Determining the insertion point for the user in step 450 can also include the system automatically taking into account the orientation of the probe in the body. Conventional ultrasound probes have markings on the probe surface to indicate the right and left sides of the probe, allowing the user to adjust the orientation of the probe so that the marking is on the patient's right side, for example. This adjustment to the probe orientation can also be determined from analysis of acquired ultrasound images or monitoring the orientation of the marking, such as with an external camera. In some configurations, a needle guidance attachment can be configured to fit over the markings on the probe to ensure the device matches the orientation of the probe.

[0034] A safety check can also be performed as part of determining the needle insertion point in step 450. The safety check can include verifying that there are no critical structures interfering with the needle's path through the vessel, such as bone, unintended blood vessels, non-target organs, nerves, etc. The safety check can also include having the system change the penetration location to avoid penetrating such critical structures. In some configurations, the safety check can include verifying that the needle has penetrated the vessel of interest through tracking and guidance in step 460. The safety check can also include determining that the user is holding the system in a stable position, as verified from ultrasound images or from an inertial measurement unit located on the system's handle.

[0035] Referring to FIG. 4B , a flowchart illustrating a method for guiding needle penetration into a vessel of interest illustrates steps in one non-limiting example. At step 465, ultrasound imaging data is acquired to identify a probe position. At step 470, image quality can be identified, and at step 475, safety of the probe position for penetration of the vessel within the treatment object can be identified. At step 480, a location of the vessel of interest in the imaging data can be identified. At step 485, the boundary of the vessel of interest can be segmented and the centroid of the vessel of interest can be calculated. At step 490, the probe can be guided to an insertion point. At step 495, sufficient separation between the vessels can be identified or confirmed. If there is not sufficient separation, the probe can be guided to a new insertion position at step 490. If there is sufficient separation, at step 497, a signal can be provided to the user to proceed with needle insertion. Such a signal can be provided on a graphical user interface, via a light on the probe, or the like. At step 499, the needle can be tracked to confirm penetration of the vessel.

[0036] In some configurations, the method includes guiding a user in placing an ultrasound probe into a treatment target. A penetration target can be identified and localized, such as by machine learning, as disclosed herein. The user can then be guided as to which direction to move the ultrasound probe to position it on the identified target. When the ultrasound probe reaches the target location, a signal can indicate to the user that they should stop moving the probe. In one non-limiting example, guidance can be provided by a signal, such as a light on the probe. After the target location is reached, needle placement and penetration can proceed.

[0037] Referring to Figure 5, an example system 500 for generating and implementing a hybrid machine learning and mechanistic model of some embodiments of the systems and methods described in this disclosure is shown. As shown in Figure 5, a computing device 550 may receive one or more types of data (e.g., ultrasound, multi-parametric MRI data, image data of a vessel of interest, etc.) from an image source 502. In some embodiments, the computing device 550 may execute at least a portion of a vessel of interest image processing system 504 to generate an image of the vessel of interest or otherwise segment the vessel of interest from the data received from the image source 502.

[0038] Additionally or alternatively, in some embodiments, computing device 550 may transmit information regarding the data received from image source 502 via communications network 554 to server 552, which may execute at least a portion of vessel of interest processing system 504 to generate an image of the vessel of interest or otherwise segment the vessel of interest from the data received from image source 502. In such embodiments, server 552 may return information indicative of the output of vessel of interest image processing system 504 to computing device 550 (and / or any other suitable computing device) to generate an image of the vessel of interest or otherwise segment the vessel of interest from the data received from image source 502.

[0039] In some embodiments, computing device 550 and / or server 552 may be any suitable computing device or combination of devices, such as a desktop computer, a laptop computer, a smartphone, a tablet computer, a wearable computer, a server computer, a virtual machine running on a physical computing device, etc. Computing device 550 and / or server 552 may also reconstruct an image from the data.

[0040] In some embodiments, image source 502 may be any source of image data (e.g., measurement data, images reconstructed from measurement data, etc.), such as an ultrasound system, another computing device (e.g., a server that stores image data), etc. In some embodiments, image source 502 may be local to computing device 550. For example, image source 502 may be integrated with computing device 550 (e.g., computing device 550 may be part of a device for capturing, scanning, and / or storing images). As another example, image source 502 may be connected to computing device 550 by a cable, a direct wireless link, etc. Additionally or alternatively, in some embodiments, image source 502 may be located locally to computing device 550 and / or remotely from computing device 550, and image source 502 may transmit data to computing device 550 (and / or server 552) via a communications network (e.g., communications network 554, etc.).

[0041] In some embodiments, communications network 554 may be any suitable communications network or combination of communications networks. For example, communications network 554 may include a Wi-Fi network (which may include one or more wireless routers, one or more switches, etc.), a peer-to-peer network (e.g., a Bluetooth network), a cellular network (e.g., a 3G network, a 4G network, etc.), conforming to any suitable standard, such as CDMA, GSM, LTE, LTE Advanced, WiMAX, etc.), a wired network, etc. In some embodiments, communications network 108 may be a local area network, a wide area network, a public network (e.g., the Internet), a private or semi-private network (e.g., a corporate or university intranet), any other suitable type of network, or any suitable combination of networks. The communications links shown in FIG. 5 may be any suitable communications links or combinations of communications links, such as wired links, fiber optic links, Wi-Fi links, Bluetooth links, cellular links, etc.

[0042] Referring to FIG. 6 , an example of hardware 600 for implementing the image source 502, computing device 550, and server 554 of some embodiments of the systems and methods described in this disclosure is shown. As shown in FIG. 6 , in some embodiments, the computing device 550 may include a processor 602, a display 604, one or more inputs 606, one or more communication systems 608, and / or memory 610. In some embodiments, the processor 602 may be any suitable hardware processor, such as a central processing unit (“CPU”), a graphics processing unit (“GPU”), or a combination of multiple processors. In some embodiments, the display 604 may include any suitable display device, such as a computer monitor, a touchscreen, a television, or the like. In some embodiments, the input 606 may include any suitable input device and / or sensor that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, etc.

[0043] In some embodiments, communications system 608 may include any suitable hardware, firmware, and / or software for communicating information over communications network 554 and / or any other suitable communications network. For example, communications system 608 may include one or more transceivers, one or more communications chips and / or chipsets, etc. In more specific examples, communications system 608 may include hardware, firmware, and / or software that can be used to establish a Wi-Fi® connection, a Bluetooth® connection, a cellular connection, an Ethernet connection, etc.

[0044] In some embodiments, memory 610 may include any suitable one or more storage devices usable, for example, for storing instructions, values, or data usable by processor 602 or the like, for presenting stored content using display 604, for communicating with server 552 via communication system 608, etc. Memory 610 may include any suitable volatile memory, non-volatile memory, storage device, or any suitable combination thereof. For example, memory 610 may include RAM, ROM, EEPROM, one or more flash drives, one or more hard disks, one or more solid-state drives, one or more optical drives, etc. In some embodiments, memory 610 may have encoded or otherwise stored computer programs for controlling the operation of computing device 550. In such embodiments, processor 602 may execute at least a portion of the computer programs to present content (e.g., images, user interfaces, graphics, tables, etc.), receive content from server 552, transmit information to server 552, etc.

[0045] In some embodiments, server 552 may include a processor 612, a display 614, one or more inputs 616, one or more communication systems 618, and / or memory 620. In some embodiments, processor 612 may be any suitable hardware processor or combination of processors, such as a CPU, a GPU, etc. In some embodiments, display 614 may include any suitable display device, such as a computer monitor, a touchscreen, a television, etc. In some embodiments, input 616 may include any suitable input device and / or sensor that may be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, etc.

[0046] In some embodiments, communications system 618 may include any suitable hardware, firmware, and / or software for communicating information over communications network 554 and / or any other suitable communications network. For example, communications system 618 may include one or more transceivers, one or more communications chips and / or chipsets, etc. In more specific examples, communications system 608 may include hardware, firmware, and / or software that can be used to establish a Wi-Fi® connection, a Bluetooth® connection, a cellular connection, an Ethernet connection, etc.

[0047] In some embodiments, memory 620 may include any suitable one or more storage devices usable, for example, to store instructions, values, or data usable by processor 612 or the like, to present stored contents using display 614, to communicate with one or more computing devices 550, etc. Memory 620 may include any suitable volatile memory, non-volatile memory, storage device, or any suitable combination thereof. For example, memory 620 may include RAM, ROM, EEPROM, one or more flash drives, one or more hard disks, one or more solid-state drives, one or more optical drives, etc. In some embodiments, memory 620 may include encoded server programs for controlling the operation of server 552. In such embodiments, processor 612 may execute at least a portion of the server programs to send information and / or content (e.g., data, images, user interfaces, etc.) to one or more computing devices 550, receive information and / or content from one or more computing devices 550, receive instructions from one or more devices (e.g., personal computers, laptop computers, tablet computers, smartphones, etc.), etc.

[0048] In some embodiments, the image source 502 may include a processor 622, one or more image acquisition systems 624, one or more communication systems 626, and / or memory 628. In some embodiments, the processor 622 may be any suitable hardware processor or combination of processors, such as a CPU, a GPU, etc. In some embodiments, the one or more image acquisition systems 624 are generally configured to acquire data, images, or both, and may include an RF transmit / receive subsystem of an MRI system. Additionally or alternatively, in some embodiments, the one or more image acquisition systems 624 may include any suitable hardware, firmware, and / or software for coupling to and / or controlling the operation of an MRI system or an RF subsystem of an MRI system. In some embodiments, one or more portions of the one or more image acquisition systems 624 may be removable and / or replaceable.

[0049] Although not shown, it should be noted that image source 502 may include any suitable input and / or output. For example, image source 502 may include input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, a trackpad, a trackball, etc. As another example, image source 502 may include any suitable display device, such as a computer monitor, a touchscreen, a television, one or more speakers, etc.

[0050] In some embodiments, communications system 626 may include any suitable hardware, firmware, and / or software for communicating information to computing device 550 (and, in some embodiments, for communicating information to computing device 550 via communications network 554 and / or any other suitable communications network). For example, communications system 626 may include one or more transceivers, one or more communications chips and / or chipsets, etc. In more specific examples, communications system 626 may include hardware, firmware, and / or software that can be used to establish a wired connection (e.g., VGA, DVI video, USB, RS-232, etc.), a Wi-Fi® connection, a Bluetooth® connection, a cellular connection, an Ethernet connection, etc. using any suitable port and / or communications standard.

[0051] In some embodiments, memory 618 may include any suitable one or more storage devices usable, for example, to store instructions, values, or data usable by processor 622 or the like to control one or more image acquisition systems 624 and / or receive data from one or more image acquisition systems 624, to derive images from the data, to present content (e.g., images, user interfaces, etc.) using a display, to communicate with one or more computing devices 550, etc. Memory 628 may include any suitable volatile memory, non-volatile memory, storage device, or any suitable combination thereof. For example, memory 628 may include RAM, ROM, EEPROM, one or more flash drives, one or more hard disks, one or more solid-state drives, one or more optical drives, etc. In some embodiments, memory 628 may have encoded or otherwise stored programs for controlling the operation of image source 502. In such an embodiment, the processor 622 may execute at least a portion of a program to generate images, transmit information and / or content (e.g., data, images, etc.) to one or more computing devices 550, receive information and / or content from one or more computing devices 550, receive instructions from one or more devices (e.g., personal computers, laptop computers, tablet computers, smartphones, etc.), etc.

[0052] In some embodiments, any suitable computer-readable medium can be used to store instructions for performing the functions and / or steps described herein. For example, in some embodiments, a computer-readable medium can be transitory or non-transitory. For example, a non-transitory computer-readable medium can include magnetic media (e.g., hard disks, floppy disks), optical media (e.g., compact discs, digital video discs, Blu-ray discs), semiconductor media (e.g., random access memory (“RAM”), flash memory, electrically programmable read-only memory (“EPROM”), electrically erasable programmable read-only memory (“EEPROM”), etc.), any suitable medium that is not transient during transmission and does not suffer any tangible loss of persistence, and / or any suitable tangible medium. As another example, a transitory computer-readable medium can include signals on a network, in wires, in conductors, in optical fibers, in circuits, or any suitable medium that is not transient or suffers any tangible loss of performance during transmission, and / or any suitable intangible medium.

[0053] 7A is a perspective view of a non-limiting example invasive device-guided injection assembly 700 coupled to an ultrasound probe. Shown in this figure is a base 740 with an ultrasound handle fixture 730 that provides a detachable connection to an ultrasound probe 710. The injection assembly 700 can be attached to any ultrasound device, such as by strapping it to the ultrasound probe 710 using the ultrasound handle fixture 730. The base 740 can include a mechanical support that rests on the skin surface to minimize recoil and improve needle insertion accuracy.

[0054] FIG. 7B is a side view of the invasive device guided injection assembly 700 of FIG. 7A. In one non-limiting example, the base 740 includes a motor for setting the angle of insertion of the invasive device, which can be a needle. The base 740 can also include a second drive motor for driving the invasive device to a desired depth. The motor can be controlled to vary the needle insertion speed with insertion depth, for example, inserting the needle into the skin relatively slowly to minimize recoil and improve accuracy, followed by a faster insertion. In some configurations, the function of the drive motor can be replaced or augmented by a spring or any other suitable means for storing mechanical energy, an additional motor or other suitable mechanical actuation means for enabling injection into the target. A cartridge 720 is detachably coupled to the base 740 and can be configured to correspond to the procedure being performed. In non-limiting examples, the cartridge 720 can be configured to treat indications requiring vascular access, tension pneumothorax, or airway management. A non-limiting example cartridge configuration is listed in Table 1 below.

[0055] Table 1 - Non-limiting exemplary cartridge configurations [Table 1]

[0056] FIG. 7C is a side view of the base and ultrasound probe fixture for the invasive device guide of FIG. 7B. The base 740 includes a drive motor 745 for setting the angle of entry and / or insertion depth of the invasive device held by the cartridge slot 725 coupled by the cartridge coupling 722. An advancement motor 747 can be provided for advancing the invasive device through actuation by an advancement control 755, which, in one non-limiting example, is a button. An electrical interface connector 752 can provide communication with an ultrasound imaging system or a separate display system. User guidance signals 750 provide feedback to the user and can take the form of any display intended to guide the user during general and / or detailed placement of the device. In one non-limiting example, the user guidance signals 750 include an array of LEDs. In some configurations, the user guidance signals 750 can be coupled to the cartridge 720 and can be signals specific to a particular display during a procedure.

[0057] Figure 7D is a cross-sectional view of a non-limiting example cartridge 720 that fits into the injection assembly 700 of Figure 7B. A lead screw 760 may actuate a base coupling 770 to couple the non-limiting example cartridge 720 to the base 740 of Figure 7B. As a non-limiting example of a needle cartridge application, needle cartridge 765 is shown.

[0058] FIG. 8A is a perspective view of a non-limiting example invasive device guide integrated with an ultrasound probe. The integrated invasive device guide 800 is shown positioned on a treatment target 810. The integrated invasive device guide 800 can have similar functionality to the above-described injection assembly 700 integrated with an ultrasound probe. The integrated invasive device guide 800 can be ultrasonically guided, and the present disclosure can use machine learning or artificial intelligence to identify target structures for penetration and guidance of the penetration of the target structures. The integrated ultrasound transducer can provide excitation, source reading, ultrasound signal processing, etc. The integrated invasive device guide 800 can include on-board artificial intelligence algorithms, motors, associated drive circuits, other electronic / mechanical components, etc., housed within a housing 805 to form the integrated device guide 800. A cartridge, such as those described herein, can be removably coupled to the integrated invasive device guide 800. In some configurations, the integrated invasive device guide 800 can be robotically controlled.

[0059] FIG. 8B is an exploded view of the integrated invasive device guidance portion 800 and ultrasound probe of FIG. 8A. A circuit board 820 can provide ultrasound guidance via an ultrasound transducer 840, and the present disclosure can employ machine learning or artificial intelligence to identify target structures for penetration and guidance of the target structure. A battery 830 can power the integrated device. While FIG. 8B shows one battery cell, it is clear that any number of battery cells can be used, such as two cells for extended life, or any other form of power source. A drive train 850 can provide independent needle or invasive device insertion and cannula insertion. The needle and cannula 870 can be inserted into the target using a motor 860.

[0060] FIG. 9 is a perspective view of a non-limiting example cricothyrotomy cartridge 900 for use in the present disclosure. As noted in Table 1 above, different clinical indications may require different types of needles or other hardware / medicines to be introduced into the body. In one non-limiting example, in the case of non-compressible bleeding, blood products may need to be introduced quickly, and a needle sheath may provide a suitable diameter passage for the rapid introduction of fluids. In another non-limiting example, a catheter may be introduced, or a dilating element with a larger lumen may be required. Each cartridge may be designed with its intended use and clearly labeled for its intended use. In some configurations, the system may be able to know what type of cartridge device is being "plugged" into the system. This information may be conveyed via electrical communication, such as radio frequency or direct conduction signals, between the cartridge and base, optical communication between the cartridge and base, or mechanical keying unique to the cartridge / base assembly that indicates the type of cartridge being used. In one non-limiting example of mechanical keying, a femoral arterial / venous generation 1 cartridge from Table 1 can be configured so that the cartridge presses a first button in a cartridge slot in the base, while a generation 2 cartridge from that family can be configured so that the cartridge presses a second button. In this way, the base can distinguish which cartridge has been inserted. In some configurations, the cartridge can be located inside a sterile surgical barrier and the base can be located outside the sterile barrier, allowing communication of cartridge type through the barrier to ensure safe and effective treatment.

[0061] 10A-10E are side views of a non-limiting example of the insertion and removal of an expansion element 1010 into a treatment target. Some cartridge types listed in Table 1 require the needle insertion process to be performed in more than one step. In one non-limiting example, the cartridge can be configured to place an expansion lumen, and expansion of this lumen can be a multi-step process. In one non-limiting example, placement of a respiratory tube via the cricothyroid membrane can include a coaxial assembly with a sharp central element for puncture and initial path guidance, in addition to a coaxial element for expansion and possibly air passage, which can be deployed as shown in FIGS. 10A-10E.

[0062] 10A-10E can be fully automated by a motor or other mechanical actuation of the system, or can be a combination of automated actuation and human handling. Figure 10A shows a side view of a non-limiting example of the insertion of a dilator element 1010 into a treatment target. In some configurations, the protector can be removed to insert a disposable dilator 1010 to maintain sterility and safety.

[0063] FIG. 10B is a side view of a non-limiting example of alignment of an expansion element 1010 with an invasive device guide 1020. A needle 1030 can be deployed after device alignment, which can be coaxial with the expansion element 1010. In some configurations, the host anatomy may be sensitive or may require an additional mechanical guide for proper introduction of larger diameter elements. In such configurations, a "guidewire" device can be used to temporarily protrude from the tip of the inserted assembly, in a similar functional operation to the guidewire used in the Seldinger technique. The "guidewire" device can be deployed between the steps shown in FIGS. 10B and 10C.

[0064] FIG. 10C is a side view of a non-limiting example dilating element 1010 being advanced over a needle into a subject. The dilating element 1010 can be advanced over and coaxial with the needle 1030. The dilating element 1010 can provide access to the subject by dilating after insertion. FIG. 10D is a side view of the needle 1030 being retracted from the subject. FIG. 10E is a side view of the invasive device guide 1020 being removed, leaving the dilating element 1010 within the subject, which can be used to access the invasive device.

[0065] While this disclosure describes one or more preferred embodiments, it is apparent that many equivalents, alternatives, variations, and modifications, in addition to those explicitly described herein, are possible and within the scope of the invention.

Claims

1. 1. A system for guiding an invasive device in an invasive procedure on a subject, comprising: a guidance system coupled to an ultrasound probe, the guidance system including a base and at least one motor, the at least one motor supported by the base and drivable to move the invasive device within a field of view (FOV) of the ultrasound probe; a non-transitory memory storing instructions; a processor that accesses the non-transitory memory and executes the instructions; It is equipped with The processor: accessing image data acquired from the treatment subject using the ultrasound probe, the image data including at least one image of a target structure of the treatment subject; Identifying from the image data a location of the target structure in the treatment object and an orientation of the ultrasound probe relative to the treatment object; determining an insertion point location for the invasive device based on the location of the target structure and guiding placement of the ultrasound probe to position the guidance system at the insertion point location; determining a penetration depth of the invasive device based on the location of the target structure and the insertion point location; imparting the adjustment of the penetration depth by controlling the setting or height of the guidance system; transmitting guidance signals to the user to guide the user in coarse and fine placement of the invasive device relative to at least one of the insertion point location or the location of the target structure; Tracking the invasive device as it extends from the insertion point location to the target structure within the treatment subject. A system characterized by:

2. The processor further the angle of the invasive device from the insertion point location to the target structure; and a rotation angle of the ultrasonic probe relative to the treatment target; an insertion distance from the insertion point location to the target structure; Identifying at least one of The system of claim 1 .

3. It also has a display system, The processor further transmits the guidance signal to the display system to display at least one of the angle of the invasive device, the insertion point location, the location of the target structure, and the insertion distance. The system of claim 2.

4. the display system provides one of an indicator of the insertion point location projected near the target structure by an illuminated display coupled to the system and an indicator of the ultrasound probe position at the insertion point location. The system of claim 3.

5. The processor further provides the guidance signal to a user as real-time feedback based on tracking of the invasive device. The system of claim 1 .

6. The processor further segments the image data based on an appearance of the target structure to identify at least one of a location of the target structure and an identity of the target structure. The system of claim 1 .

7. the target structure is any one of an artery, a vein, a femoral artery, a femoral vein, a jugular vein, a peripheral vein, a subclavian vein, an airway, a lumen, a hollow organ, a body cavity, a fluid-filled anatomical space, a location requiring a biopsy, a breast, a kidney, a lymph node, a spinal canal, a location requiring a nerve block, a peritoneal cavity, or a pleural cavity; The system of claim 1 .

8. the processor, upon accessing the image data, receives a plurality of images of the target structure of the treatment subject acquired in real time; The system of claim 1 .

9. the plurality of images includes a plurality of views of the target structure; the processor evaluates the multiple views to identify critical structures in the subject and determines a location in the subject where the invasive device will reach the target structure from the insertion point location without penetrating the critical structures in the subject. The system of claim 8.

10. the critical structure includes at least one of bone, unintended blood vessels, non-target organs, or nerves; The system of claim 9.

11. the plurality of images includes images at a plurality of different time frames; The system of claim 9.

12. the guidance system includes a cartridge removably securable to a base of the guidance system; the cartridge houses the invasive device; The system of claim 1 .

13. the invasive device is any one of a needle, a wire, a dilator, a breathing tube, a chest tube, an intravascular catheter, a blood clotting agent, or a medication; The system of claim 12.

14. 14. The system of claim 13, wherein the invasive device is for performing at least one of vascular access, access to an organ or body cavity, cricothyrotomy, taking a tissue sample, or pneumothorax relief.

15. the guidance system is removably coupled to the ultrasound probe using an ultrasound handle fixture; The system of claim 1 .

16. the guidance system is coupled to the ultrasound probe by being housed in a housing integral with the ultrasound probe; The system of claim 1 .

17. The guidance system includes a power source.

16. The system of claim 15.

18. the guidance system is configured to automatically guide the invasive device. The system of claim 1 .

19. 1. A system for guiding an invasive device in an invasive procedure on a subject, comprising: i) accessing image data acquired from the treatment subject using an ultrasound probe, the image data including at least one image of a target structure of the treatment subject; ii) identifying the location of the target structure in the treatment subject from the image data; iii) determining an insertion point location for the invasive device based on the location of the target structure in the treatment object and the orientation of the ultrasound probe relative to the treatment object, and guiding placement of the ultrasound probe to position the guidance system at the insertion point location. A computer system; an ultrasound probe; a guidance system coupled to the ultrasound probe, the guidance system including a base and at least one motor, the at least one motor supported by the base and drivable to move the invasive device within a field of view (FOV) of the ultrasound probe; a display for guiding the invasive device from the insertion point location to the target structure; A system comprising:

20. The computer system further comprises the angle of the invasive device from the insertion point location to the target structure; and a rotation angle of the ultrasonic probe relative to the treatment target; an insertion distance from the insertion point location to the target structure; Identifying at least one of 20. The system of claim 19.

21. The display unit further displays at least one of the angle of the invasive device, the insertion point location, the location of the target structure, and the insertion distance.

21. The system of claim 20.

22. the display unit provides one of an indicator of the insertion point location projected near the target structure by an illuminated display coupled to the system and an indicator of the ultrasound probe position at the insertion point location.

22. The system of claim 21.

23. The computer system further tracks the invasive device from the insertion point location to the target structure and provides real-time feedback to a user based on the tracking of the invasive device.

20. The system of claim 19.

24. The computer system further segments the image data based on an appearance of the target structure to identify at least one of a location of the target structure and an identity of the target structure.

20. The system of claim 19.

25. the target structure is any one of an artery, a vein, a femoral artery, a femoral vein, a jugular vein, a peripheral vein, a subclavian vein, an airway, a lumen, a hollow organ, a body cavity, a fluid-filled anatomical space, a location requiring a biopsy, a breast, a kidney, a lymph node, a spinal canal, a location requiring a nerve block, a peritoneal cavity, or a pleural cavity; 20. The system of claim 19.

26. The computer system further receives a plurality of images of the target structure of the treatment subject acquired in real time upon accessing the image data.

20. The system of claim 19.

27. the plurality of images includes a plurality of views of the target structure; The computer system further comprises: evaluating the plurality of views to identify critical structures in the treatment object; and determining a location in the treatment object where the invasive device will reach the target structure from the insertion point location without penetrating the critical structures in the treatment object.

27. The system of claim 26.

28. the critical structure includes at least one of bone, unintended blood vessels, non-target organs, or nerves; 28. The system of claim 27.

29. the plurality of images includes images at a plurality of different time frames; 28. The system of claim 27.

30. the guidance system includes a cartridge removably securable to a base of the guidance system; the cartridge houses the invasive device; 20. The system of claim 19.

31. the invasive device is any one of a needle, a wire, a dilator, a breathing tube, a chest tube, an intravascular catheter, a blood clotting agent, or a medication; 31. The system of claim 30.

32. 32. The system of claim 31, wherein the invasive device is for performing at least one of vascular access, access to an organ or body cavity, cricothyrotomy, taking a tissue sample, or pneumothorax relief.

33. the guidance system is removably coupled to the ultrasound probe using an ultrasound handle fixture; 20. The system of claim 19.

34. the guidance system is coupled to the ultrasound probe by being housed in a housing integral with the ultrasound probe; 20. The system of claim 19.

35. The guidance system includes a power source.

35. The system of claim 34.

36. the guidance system is configured to automatically guide the invasive device.

20. The system of claim 19.

37. The at least one motor includes a first motor; the processor controls the first motor of the guidance system to adjust the angle of the invasive device. The system of claim 2.

38. The at least one motor includes a second motor; the processor controls the second motor of the guidance system to control the penetration depth of the invasive device.

38. The system of claim 37.

Images