System and method for guidewire advancement and / or stabilization

Abstract

Systems and methods are provided for semi-automated, portable, ultrasound guided cannulation. The systems and methods provide for image analysis to provide for segmentation of vessels of interest from image data. The image analysis provides for guidance for guidewire placement and insertion of a cannulation system into a subject which may be accomplished by a non-expert based upon the guidance provided. The guidance may include an indicator or a mechanical guide to guide a user for inserting the vascular cannulation system into a subject to penetrate the vessel of interest.

Description

Client. MIT 24998LJSYSTEM AND METHOD FOR GUIDEWIRE ADVANCEMENT AND / OR STABILIZATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is based on, claims priority to, and incorporates herein by reference in its entirety for all purposes, US Provisional Application Serial No. 63 / 752,532, filed January 31, 2025.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] N / ABACKGROUND

[0003] Insertion of catheters into blood vessels, veins, or arteries can be a difficult task for non-experts or in trauma applications because the vein or artery may be located deep within the body, may be difficult to access in a particular patient, or may be obscured by trauma in the surrounding region to the vessel. Multiple attempts at penetration may result in extreme discomfort to the patient, loss of valuable time during emergency situations, or in further trauma. Inability' to successfully cannulate a target vessel may preclude the delivery' of lifesaving treatments. Furthermore, critical non-target structures are often in close proximity to target vessels. For example, while attempting to access the internal jugular vein, the carotid artery' may instead be punctured, resulting in severe complications or even mortality' due to consequent blood loss due to the high pressure of the blood flowing in the artery'. Similarly, the lung apex is near the target site for the internal jugular vein placing it at significant risk of inadvertent puncture and resultant pneumothorax. Associated nerve pathways may also be found in close proximity to a vessel, such as the femoral nerve located nearby the femoral artery', puncture of which may' cause significant pain or loss of function for a patient.

[0004] Vascular access often requires the deploy ment of an indwelling catheter. To perform this task safely and effectively, a thin flexible wire (called a guidewire) is often placed co-axially through the initial needle used for vessel puncture. This permits the exchange of the needle for indwelling catheters which may be serially upsized to achieve the desired catheter size. This comprises the Seidinger technique which is widely utilized for vascular access and access to other hollow structures. Correct advancement of the guidewire requires that the operator applies sufficient force to overcome needle and tissue related friction, but recognition that substantial resistance may indicate a procedural complication. Recognition of this narrowClient. MIT 24998LJzone of tactile feedback requires substantial training and experience which precludes utilization by inexperienced operators.

[0005] Therefore, there is a need for techniques for improved guidewire placement of blood vessels that are less cumbersome, more accurate, and able to be deployed by a nonexpert.SUMMARY OF THE DISCLOSURE

[0006] The present disclosure addresses the aforementioned drawbacks by providing new systems and methods for guided vascular cannulation. Specifically, systems and methods for guidewire insertion are provided. The systems and methods provide for image analysis to provide for segmentation of vessels of interest from image data as provided in U.S. Patent Application No. 16 / 995,637 (herein incorporated by reference). The image analysis provides guidance for insertion of a guidewire into a subject and may be accomplished by a non-expert based upon the guidance provided. The guidance may include an indicator or a mechanical guide to guide a user when inserting the vascular cannulation system into a subject to penetrate the vessel of interest. The system and methods described herein are not limited to placing, advancing, and securing a guidewire in a vessel, but may also be employed for vessel cannulation, torso cavity drains, feeding tubes, implantable leads, and other applications of percutaneous access of hollow organs or structures.

[0007] In one aspect, a system for placing a guidewire in a subject is provided. The system comprises a housing comprising an ultrasound probe, a cartridge containing at least one interventional device, and a guidewire system coupled to the cartridge, wherein the guidewire system is positioned within or external to the cartridge and wherein the housing is configured to guide the interventional device and the guidewire system into a field of view (FOV) of the ultrasound probe. The system also comprises a non-transitory memory having instructions stored thereon and a processor configured to access the non-transitory memory and execute the instructions.

[0008] In one aspect, a method for placing a guidewire using any system described herein is provided. The method comprises acquiring, via the ultrasound probe, ultrasound imaging data, locating, via the processor, a vessel of interest in the ultrasound imaging data, determining, via the processor, a needle insertion point, controlling, via the processor, insertion of the needle into the vessel, inserting a guidewire through the needle into the vessel, and advancing the guidewire into the vessel.

[0009] The foregoing and other aspects and advantages of the present disclosure willClient. MIT 24998LJappear from the following description. In the description, reference is made to the accompanying drawings that form a part hereof, and in which there is shown by way of illustration a preferred embodiment. This embodiment does not necessarily represent the full scope of the invention, however, and reference is therefore made to the claims and herein for interpreting the scope of the invention. Like reference numerals will be used to refer to like parts from Figure to Figure in the following description.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a schematic diagram of a non-limiting example ultrasound system that can implement the systems and methods described in the present disclosure.

[0011] FIG. 2 is a schematic diagram of a non-limiting example configuration for guiding needle insertion into a vessel of interest using an ultrasound probe.

[0012] FIG. 3 is a flowchart of non-limiting example steps for a method of operating a system for guiding a guidewire system.

[0013] FIG. 4A is another flowchart of non-limiting example steps for a method of operating a system for guiding a guidewire system.

[0014] FIG. 4B is a flowchart of non-limiting example steps for a method of guiding needle penetration of a vessel of interest.

[0015] FIG. 4C is a flowchart of non-limiting example steps of placing, advancing, and stabilizing a guidewire in a vessel of interest.

[0016] FIG. 5 is a block diagram of an example system that can implement a vessel of interest image processing system for generating images of a vessel of interest or otherwise measuring or predicting a location for a vessel of interest using a hybrid machine learning and mechanistic model.

[0017] FIG. 6 is a block diagram of example hardware components of the system of FIG. 5.

[0018] FIG. 7A is a perspective view of a non-limiting example interventional device guide coupled to an ultrasound probe.

[0019] FIG. 7B is a side view of the interventional device guide of FIG. 7A.

[0020] FIG. 7C is a side view of the base and ultrasound probe fixture for the interventional device guide of FIG. 7B.

[0021] FIG. 7D is a cross-section of a non-limiting example cartridge compatible with the injection assemble of FIG. 7B.

[0022] FIG. 8A is a perspective view of a non-limiting example interventional device guide integrated with an ultrasound probe.Client. MIT 24998LJ

[0023] FIG. 8B is an exploded view of the integrated interventional device guide and ultrasound probe of FIG. 8A.

[0024] FIG. 9 is perspective view of a non-limiting example cricothyrotomy cartridge for use in accordance with the present disclosure.

[0025] FIG. 10A is a side view of inserting a non-limiting example dilating component into the interventional device guide.

[0026] FIG. 10B is a side view of aligning the non-limiting example dilating component with the interventional device guide and advancing a needle to guide the nonlimiting example dilating component into the subject.

[0027] FIG. 10C is a side view of advancing the non-limiting example dilating component over the needle and into the subject.

[0028] FIG. 10D is a side view of retracting the needle and leaving the non-limiting example dilating component in the subject.

[0029] FIG. 1 OE is a side view of removing the interventional device guide and leaving the non-limiting example dilating component in the subject.

[0030] FIG. 11 A is a side elevational view of a guidewire system in accordance with the present disclosure.

[0031] FIG. 1 IB is a partial, internal view of a guidewire advancement system in accordance with the present disclosure.

[0032] FIG. 11C is a schematic view of the driving wheel of the guidewire advancement system in accordance with the present disclosure.

[0033] FIG. 12A is a perspective view7of the guidewire stabilizer of the guidewire system secured on a cartridge in accordance with the present disclosure.

[0034] FIG. 12B is a first elevational view of a guidewire stabilizer of the guidewire system and cartridge in accordance with the present disclosure.

[0035] FIG. 12C is a second elevational view of the guidewire stabilizer of the guidewire system and cartridge in accordance with the present disclosure.

[0036] FIG. 12D is a third elevational view of the guidewire stabilizer of the guidewire system and cartridge in accordance with the present disclosure.DETAILED DESCRIPTION

[0037] FIG. 1 illustrates an example of an ultrasound system 100 that can implement the methods described in the present disclosure. The ultrasound system 100 includes a transducer array 102 that includes a plurality of separately driven transducer elements 104. The transducer array 102 can include any suitable ultrasound transducer array, including linearClient. MIT 24998LJarrays, curved arrays, phased arrays, and so on. Similarly, the transducer array 102 can include a ID transducer, a 1.5D transducer, a 1.75D transducer, a 2D transducer, a 3D transducer, and so on.

[0038] When energized by a transmitter 106, a given transducer element 104 produces a burst of ultrasonic energy. The ultrasonic energy7reflected back to the transducer array 102 (e.g., an echo) from the object or subject under study is converted to an electrical signal (e.g., an echo signal) by each transducer element 104 and can be applied separately to a receiver 108 through a set of switches 110. The transmitter 106, receiver 108, and switches 110 are operated under the control of a controller 112, which may include one or more processors. As one example, the controller 112 can include a computer system.

[0039] The transmitter 106 can be programmed to transmit unfocused or focused ultrasound waves. In some configurations, the transmitter 106 can also be programmed to transmit diverged waves, spherical waves, cylindrical waves, plane waves, or combinations thereof. Furthermore, the transmitter 106 can be programmed to transmit spatially or temporally encoded pulses.

[0040] The receiver 108 can be programmed to implement a suitable detection sequence for the imaging task at hand. In some embodiments, the detection sequence can include one or more of line-by-line scanning, compounding plane wave imaging, synthetic aperture imaging, and compounding diverging beam imaging.

[0041] In some configurations, the transmitter 106 and the receiver 108 can be programmed to implement a high frame rate. For instance, a frame rate associated with an acquisition pulse repetition frequency (“PRF”) of at least 100 Hz can be implemented. In some configurations, the ultrasound system 100 can sample and store at least one hundred ensembles of echo signals in the temporal direction.

[0042] The controller 112 can be programmed to implement an imaging sequence using the techniques described in the present disclosure, or as otherwise known in the art. In some embodiments, the controller 112 receives user inputs defining various factors used in the design of the imaging sequence.

[0043] A scan can be performed by setting the switches 110 to their transmit position, thereby directing the transmitter 106 to be turned on momentarily to energize transducer elements 104 during a single transmission event according to the implemented imaging sequence. The switches 110 can then be set to their receive position and the subsequent echo signals produced by the transducer elements 104 in response to one or more detected echoesClient. MIT 24998LJare measured and applied to the receiver 108. The separate echo signals from the transducer elements 104 can be combined in the receiver 108 to produce a single echo signal.

[0044] The echo signals are communicated to a processing unit 114, which may be implemented by a hardware processor and memory, to process echo signals or images generated from echo signals. As an example, the processing unit 114 can guide placement of a guidewire in a vessel of interest using the methods described in the present disclosure. Images produced from the echo signals by the processing unit 114 can be displayed on a display system 116.

[0045] In some configurations, a non-limiting example method may be deployed on an imaging system, such as a commercially available imaging system, to provide for a portable ultrasound system with guidewire placement guidance. The method may locate a vessel of interest, such as a vein or an artery as a user or medic moves an ultrasound probe. The system and method may provide real-time guidance to the user to position the ultrasound probe to the optimal needle insertion point. The probe may include one or more of a fixed needle guide device, an adjustable mechanical needle guide, a displayed-image needle guide, and the like. An adjustable guide may include adjustable angle and / or depth. The system may guide, or communicate placement or adjustments for the guide for the needle. The system may also regulate the needle insertion distance based upon the depth computed for the vessel of interest. The user may then insert a needle through the mechanical guide attached to the probe or displayed guide projected from the probe in order to ensure proper insertion. During needle insertion, the system may proceed to track the target blood vessel and the needle until the vessel is penetrated. A graphical user interface may be used to allow the medic to specify the desired blood vessel and to provide feedback to the medic throughout the process.

[0046] For the purposes of this disclosure and accompanying claims, the term “real time" or related terms are used to refer to and defined a real-time performance of a system, which is understood as performance that is subject to operational deadlines from a given event to a system’s response to that event. For example, a real-time extraction of data and / or displaying of such data based on acquired ultrasound data may be one triggered and / or executed simultaneously with and without interruption of a signal-acquisition procedure.

[0047] In some configurations, the system may automate all ultrasound image interpretation and insertion computations, while a medic or a user may implement steps that require dexterity, such as moving the probe and inserting the needle. Division of labor in this manner may avoid using a dexterous robot arm and may result in a small system that incorporates any needed medical expertise.Client. MIT 24998LJ

[0048] Referring to FIG. 2, a diagram is shown depicting a non-limiting example embodiment for guiding needle insertion into a femoral artery 230 or femoral vein 240. An ultrasound probe 210 is used to acquire an image 220 of a region of interest that includes a portion of the femoral artery 230, femoral vein 240 and other objects of interest such as femoral nerve 250. The locations of the femoral artery 230, femoral vein 240, and femoral nerve 250 may be annotated on the image 220. A mechanical needle guide 260 may be included to guide a needle 270 to penetrate the vessel of interest, such as femoral vein 240 as shown. In some configurations, visual needle guide 265 may be included where a penetration guide image 266 is projected onto the surface of a subject to guide a needle 270 to penetrate the vessel of interest, such as to femoral artery- 230 as shown. Penetration guide image 266 may reflect the actual size or depth of the vessel of interest for penetration when projected onto the subject, or may provide other indicators such as measurements or a point target for penetration, and the like.

[0049] The vessels of interest may include a femoral artery, femoral vein,jugular vein, peripheral veins, subclavian vein, cephalic vein, basilic vein, airway, lumen, luminal organ, body cavity, fluid filled anatomic space, location requiring biopsy, breast, kidney, lymph node, spinal canal, location requiring nerve block, peritoneal space, pleural space, and / or other vessels or non-vessel structures. Non-limiting example applications may include aiding a medic in performing additional emergency needle insertion procedures, such as needle decompression for tension pneumothorax (collapsed lung) and needle cricothyrotomy (to provide airway access). Portable ultrasound may be used to detect tension pneumothorax and needle insertion point (in an intercostal space, between ribs) or to detect the cricothyroid membrane and needle insertion point.

[0050] Referring to FIG. 3, provides non-limiting example steps of a method of operating a guidewire system. At step 310. imaging data is accessed. This may be achieved by performing an imaging acquisition and / or accessing pre-acquired image data. Imaging data may include ultrasound data, and / or may include any other form of medical imaging data, such as magnetic resonance imaging (MRI), computed tomography (CT), PET, SPECT, fluoroscopy, and the like. Using the imaging data, a vessel of interest may be determined at step 320. The location may be determined by segmenting the vessels of interest in the imaging data. Vessels of interest may include a femoral artery, femoral vein, jugular vein, peripheral veins, subclavian vein, and the like. An insertion point may then be determined at step 330 for a guidewire system. In a non-limiting example, the guidewire system include a needle. Determining the insertion point may be based upon the determined location for the vessel of interest and calculating a depth and a pathway for the needle from the surface of a subject toClient. MIT 24998LJthe vessel of interest to provide access for the guidewire without the needle penetrating other organs of interest, such as a nerve. The insertion point may be determined for a user at step 340. The insertion point may be identified by illuminating a portion of the surface of a subject, or by adjusting a mechanical needle guide to the appropriate settings for the user, and the like. Depth of the needle penetration may also be controlled by a setting or a height of the mechanical guide. The needle of the guidewire system may be guided to the vessel of interest for vessel penetration at step 350. Guiding the needle may include acquiring images of the vessel of interest and the needle as the needle is inserted into the subject and displaying the tracked images for the user.

[0051] Referring to FIG. 4A, non-limiting example steps are shown in another flowchart setting forth a method of guiding guidewire placement. A target location for ultrasound transducer placement is identified by the system as having been reached at step 402. Ultrasound imaging data is acquired at step 404 from the target location. A location for a vessel of interest in the imaging data is determined at step 406. Vessels of interest are segmented in the ultrasound imaging data at step 408. An insertion point may then be determined at step 410 for a needle. Determining the insertion point may be based upon the determined and segmented location for the vessel of interest. In some configurations, the method includes calculating a depth and a pathway from the surface of a subject to the vessel of interest without the needle penetrating other organs or structures of interest along the pathway, such as a nerve. The insertion point may also be identified for a user at step 410. As above, the insertion point may be identified by illuminating a portion of the surface of a subject, by ensuring a fixed needle guide is placed over the insertion point, or by automatically adjusting an adjustable mechanical needle guide to the appropriate settings for the user, and the like. Depth of the needle penetration may also be controlled by an adjusted setting for the adjustable mechanical guide, or a fixed height of the fixed guide. The needle may be tracked and guided to the vessel of interest for vessel penetration at step 412. Guiding the needle may include acquiring ultrasound images of the vessel of interest and the needle as the needle is inserted into the subject and displaying the tracked images for the user.

[0052] Any ultrasound probe may be used in accordance with the present disclosure, including ID, 2D, linear, phased array, and the like. In some configurations, an image is displayed for a user of the vessel of interest with any tracking information for the needle overlaid on the image. In some configurations, no image is displayed for a user and instead only the insertion point may be identified by illuminating a portion of the surface of a subject. In some configurations, no image is displayed and the user is only informed of the probeClient. MIT 24998LJreaching the proper location whereby a mechanical needle guide is automatically adjusted to the appropriate settings, such as angle and / or depth to target a vessel of interest. The user may be informed of the probe reaching the proper location by any appropriate means, such as light indicator, a vibration of the probe, and the like.

[0053] In some configurations, identification of placement of the ultrasound transducer at a target location may be performed automatically by the system at step 402. Image data may be used for identifying anatomy, such as a femoral triangle, jugular region, and the like, and may be accessed by the system to provide automatic identification for where the ultrasound transducer has been placed. In some configurations, a user may specify the vessel of interest to be targeted, such as whether to target an artery or a vein. In a non-limiting example combination of the configurations, the location of the ultrasound transducer on the subject may be automatically determined along with the anatomy being imaged, with the user specifying the vessel of interest to target in the automatically identified anatomy. A minimum of user input may be used in order to mitigate the time burden on a user.

[0054] Segmenting the vessels of interest at step 408 may be based on machine learning of morphological and spatial information in the ultrasound images. In some configurations, a neural network may be deployed for machine learning and may leam features at multiple spatial and temporal scales. Vessels of interest may be distinguished based on shape and / or appearance of the vessel wall, shape and / or appearance of surrounding tissues, and the like. In a non-limiting example, stiffer walls and a circular shape may be used to distinguish an artery in an image, whereas an ellipsoidal shape may be used to identify a vein. Real-time vessel segmentation may be enabled by a temporally trained routine without a need for conventional post-hoc processing.

[0055] Temporal information may be used with segmenting the vessels of interest at step 408. Vessel appearances and shape may change with movement of the anatomy over time, such as changes with heartbeat, or differences in appearance between hypotensive and normal-tensile situations. Machine learning routines may be trained with data from multiple time periods with differences in anatomy being reflected over the different periods of time. With a temporally trained machine learning routine, vessel segmentation may be performed in a robust manner over time for a subject without misclassification and without a need to find a specific time frame or a specific probe position to identify vessels of interest.

[0056] In some configurations, to prevent any potential misclassifications conflicting information checks may be included in the system. A conflicting information check may include taking into consideration the general configuration of the anatomy at the location ofClient. MIT 24998LJthe probe. In a non-limiting example, if the system initially identifies two arteries at a location of the probe, but the general anatomy at the location of the probe indicates that an artery and a vein should be returned as results instead, then the system will automatically correct to properly identify an artery and a vein instead of the mistaken two arteries to prevent a misclassification.

[0057] Identify ing an insertion point for a user at step 410 may also include where the system automatically takes into account the orientation of the probe on a body. A conventional ultrasound probe includes markings on the probe to indicate the right vs left side of probe, which allows a user to orient a probe such that the mark is on the right of the patient, for example. The probe orientation may be also be determined from an analysis of the acquired ultrasound images, or monitoring of the orientation of the markings, such as by an external camera. In some configurations, the needle guide attachment may be configured fit into the markings on the probe to ensure that the device is consistent with the orientation of the probe.

[0058] A safety check may also be performed as part of determining an insertion point at step 410 for a needle. A safety check may include confirming that there are no critical structures, such as a bone, an unintended blood vessel, anon-target organ, a nerve, and the like, intervening on the needle’s path to penetrate the vessel. The safety check may also include forcing the system to change the location of the penetration to avoid penetrating such critical structures. In some configurations, the safety check may include confirming the needle has penetrated the vessel of interest by the tracking and guidance at step 412. The safety check may also include determining that the user is holding the system in a stable position, by verifying from the ultrasound image or from an inertial measurement unit on the handle of the system.

[0059] Referring to FIG. 4B, non-limiting example steps are shown in a flowchart setting forth a method of guiding needle penetration of a vessel of interest. Ultrasound imaging data is acquired and a probe location is determined at step 420. An image quality may be determined at step 422, and the safety of the probe location for penetrating a vessel in the subject may be determined at step 424. Vessels may be located in the imaging data at step 426. A vessel of interest’s boundary may be segmented and a centroid calculated for the vessel of interest at step 428. The probe may be guided to an insertion point at step 430. Sufficient separation between vessels may be determined or confirmed at step 432. If there is not sufficient separation, the probe may be guided to a new insertion position at step 430. If there is sufficient separation, then a signal may be provided to a user to proceed with needle insertion at step 434. Such a signal may be provided on a graphical user interface, or a light in the probe, and the like. The needle may be tracked and vessel penetration confirmed at step 436.

[0060] In some configurations, the method includes guiding a user in placement of theClient. MIT 24998LJultrasound probe on the subj ect. A target for penetration may be identified, such as by machine learning in accordance with the present disclosure, and localized. A user may then be guided in which direction to move the ultrasound probe for placement over an identified target. Once the ultrasound probe has reached the target location, a signal may indicate for the user to stop moving the probe. Guidance may be provided by the signal, such as the light on the probe, in a non-limiting example. Needle placement and penetration may proceed after the location of the target has been reached.

[0061] Referring to FIG. 4C, a method of inserting the guidewire is presented after penetration of the vessel from step 436. At step 440, the guidewire is inserted through the needle into the vessel. In this example, the needle is a hollow needle. In anon-limiting example, the guidewire insertion may be tracked as it inserts the vessel. For example, the imaging systems described herein may visualizes the guidewire insertion and position. At step 442, the guidewire may be advanced into the vessel. As will be described in more detail below, the guidewire may be advanced or retracted based on an automated or manual function of the guidewire system. The advancement or retraction may also be tracked in the imaging data to ensure safe positioning or extension outside the target vessel or lumen. In an alternative example, the amount of the guidewire inserted or advanced into the vessel may be determined by computing the length of the guidewire based on a rotation of the wheels in the guidewire advancement system as described in greater detail below. Alternatively, the systems described herein may non-invasively sense guidewire passage friction or the required force for advancement. The degree of advancement into the vessel may be provided on user interface. In scenarios where the system sense that the guidewire is beyond the target vessel or lumen, the guidewire system may stop insertion or advancement, provide an alert to stop insertion or advancement, or automatically retract the guidewire. The alert may be provided visually on a user interface, audibly, or via tactile feedback.

[0062] At step 444, the needle may be withdrawn over the guidewire. Alternatively, a catheter or other interventional device may be inserted into the vessel over the needle and guidewire before withdrawal of the needle and guidewire as performed in radial arterial catheter placements (i.e.. modified / accelerate Seidinger technique).

[0063] At step 446 (after withdrawal of the needle over the guidewire), the guidewire is stabilized. As will be described in further details below the guidewire may be stabilized using a guidewire stabilizer configured to clamp the guidewire in place.

[0064] At step 448, at least one of the guidewire system, cartridge, or assembly is removed while leaving the guidewire in place in the vessel. Thereafter, an interventional deviceClient. MIT 24998LJmay be inserted into the vessel over the guidewire.

[0065] In a non-limiting example, every step of method of FIG. 4C need not be performed. For example, the method may terminate after any of the steps.

[0066] Referring to FIG. 5, an example of a system 500 for generating and implementing a hybrid machine learning and mechanistic model in accordance with some embodiments of the systems and methods described in the present disclosure is shown. As shown in FIG. 5, a computing device 550 can receive one or more types of data (e.g., ultrasound, multiparametric MRI data, vessel of interest image data, and the like) from image source 502. In some embodiments, computing device 550 can execute at least a portion of a vessel of interest image processing system 504 to generate images of a vessel of interest, or otherwise segment a vessel of interest from data received from the image source 502.

[0067] Additionally or alternatively, in some embodiments, the computing device 550 can communicate information about data received from the image source 502 to a server 552 over a communication network 554, which can execute at least a portion of the vessel of interest image processing system 504 to generate images of a vessel of interest, or otherwise segment a vessel of interest from data received from the image source 502. In such embodiments, the server 552 can return information to the computing device 550 (and / or any other suitable computing device) indicative of an output of the vessel of interest image processing system 504 to generate images of a vessel of interest, or otherwise segment a vessel of interest from data received from the image source 502.

[0068] In some embodiments, computing device 550 and / or server 552 can 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 being executed by a physical computing device, and so on. The computing device 550 and / or server 552 can also reconstruct images from the data.

[0069] In some embodiments, image source 502 can be any suitable source of image data (e.g., measurement data, images reconstructed from measurement data), such as an ultrasound system, another computing device (e.g., a server storing image data), and so on. In some embodiments, image source 502 can be local to computing device 550. For example, image source 502 can be incorporated with computing device 550 (e g., computing device 550 can be configured as part of a device for capturing, scanning, and / or storing images). As another example, image source 502 can be connected to computing device 550 by a cable, a direct wireless link, and so on. Additionally or alternatively, in some embodiments, image source 502 can be located locally and / or remotely from computing device 550, and can communicate dataClient. MIT 24998LJto computing device 550 (and / or server 552) via a communication network (e.g., communication network 554).

[0070] In some embodiments, communication network 554 can be any suitable communication network or combination of communication networks. For example, communication network 554 can include a Wi-Fi network (which can 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., complying with any suitable standard, such as CDMA, GSM, LTE, LTE Advanced, WiMAX, etc.), a wired network, and so on. In some embodiments, communication network 108 can 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. Communications links shown in FIG. 5 can each be any suitable communications link or combination of communications links, such as wired links, fiber optic links, Wi-Fi links, Bluetooth links, cellular links, and so on.

[0071] Referring now to FIG. 6, an example of hardware 600 that can be used to implement image source 502, computing device 550, and server 554 in accordance with some embodiments of the systems and methods described in the present disclosure is shown. As shown in FIG. 6, in some embodiments, computing device 550 can 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, processor 602 can be any suitable hardware processor or combination of processors, such as a central processing unit (‘'CPU”), a graphics processing unit (“GPU”), and so on. In some embodiments, display 604 can include any suitable display devices, such as a computer monitor, a touchscreen, a television, and so on. In some embodiments, inputs 606 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on.

[0072] In some embodiments, communications systems 608 can include any suitable hardware, firmware, and / or software for communicating information over communication network 554 and / or any other suitable communication networks. For example, communications systems 608 can include one or more transceivers, one or more communication chips and / or chip sets, and so on. In a more particular example, communications systems 608 can 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, and so on.

[0073] In some embodiments, memory 610 can include any suitable storage device or devices that can be used to store instructions, values, data, or the like, that can be used, forClient. MIT 24998LJexample, by processor 602 to present content using display 604, to communicate with server 552 via communications system(s) 608, and so on. Memory 610 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof. For example, memory 610 can 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, and so on. In some embodiments, memory 610 can have encoded thereon, or otherwise stored therein, a computer program for controlling operation of computing device 550. In such embodiments, processor 602 can execute at least a portion of the computer program to present content (e.g., images, user interfaces, graphics, tables), receive content from server 552, transmit information to server 552, and so on.

[0074] In some embodiments, server 552 can include a processor 612. a display 614, one or more inputs 616, one or more communications systems 618, and / or memory 620. In some embodiments, processor 612 can be any suitable hardware processor or combination of processors, such as a CPU, a GPU, and so on. In some embodiments, display 614 can include any suitable display devices, such as a computer monitor, a touchscreen, a television, and so on. In some embodiments, inputs 616 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on.

[0075] In some embodiments, communications systems 618 can include any suitable hardware, firmware, and / or software for communicating information over communication network 554 and / or any other suitable communication networks. For example, communications systems 618 can include one or more transceivers, one or more communication chips and / or chip sets, and so on. In a more particular example, communications systems 618 can 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, and so on.

[0076] In some embodiments, memory 620 can include any suitable storage device or devices that can be used to store instructions, values, data, or the like, that can be used, for example, by processor 612 to present content using display 614, to communicate with one or more computing devices 550, and so on. Memory 620 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof. For example, memory 620 can 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, and so on. In some embodiments, memory 620 can have encoded thereon a server program for controlling operation of server 552. In such embodiments, processor 612 can execute at least a portion ofClient. MIT 24998LJthe server program to transmit information and / or content (e.g., data, images, a user interface) 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., a personal computer, a laptop computer, a tablet computer, a smartphone), and so on.

[0077] In some embodiments, image source 502 can include a processor 622, one or more image acquisition systems 624, one or more communications systems 626, and / or memory 628. In some embodiments, processor 622 can be any suitable hardware processor or combination of processors, such as a CPU, a GPU, and so on. In some embodiments, the one or more image acquisition systems 624 are generally configured to acquire data, images, or both, and can include an RF transmission and reception subsystem of an MRI system. Additionally or alternatively, in some embodiments, one or more image acquisition systems 624 can include any suitable hardware, firmware, and / or software for coupling to and / or controlling operations 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 can be removable and / or replaceable.

[0078] Note that, although not shown, image source 502 can include any suitable inputs and / or outputs. For example, image source 502 can 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, and so on. As another example, image source 502 can include any suitable display devices, such as a computer monitor, a touchscreen, a television, etc., one or more speakers, and so on.

[0079] In some embodiments, communications systems 626 can include any suitable hardware, firmware, and / or software for communicating information to computing device 550 (and, in some embodiments, over communication network 554 and / or any other suitable communication networks). For example, communications systems 626 can include one or more transceivers, one or more communication chips and / or chip sets, and so on. In a more particular example, communications systems 626 can include hardware, firmware and / or software that can be used to establish a wired connection using any suitable port and / or communication standard (e.g., VGA, DVI video, USB, RS-232, etc.), Wi-Fi connection, a Bluetooth connection, a cellular connection, an Ethernet connection, and so on.

[0080] In some embodiments, memory 628 can include any suitable storage device or devices that can be used to store instructions, values, data, or the like, that can be used, for example, by processor 622 to control the one or more image acquisition systems 624. and / or receive data from the one or more image acquisition systems 624; to images from data; presentClient. MIT 24998LJcontent (e.g., images, a user interface) using a display; communicate with one or more computing devices 550; and so on. Memory 628 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof. For example, memory 628 can 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, and so on. In some embodiments, memory 628 can have encoded thereon, or otherwise stored therein, a program for controlling operation of image source 502. In such embodiments, processor 622 can execute at least a portion of the program to generate images, transmit information and / or content (e.g., data, images) 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., a personal computer, a laptop computer, a tablet computer, a smartphone, etc.), and so on.

[0081] In some embodiments, any suitable computer readable media can be used for storing instructions for performing the functions and / or processes described herein. For example, in some embodiments, computer readable media can be transitory' or non-transitory. For example, non-transitory computer readable media can include media such as 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”)), any suitable media that is not fleeting or devoid of any semblance of permanence during transmission, and / or any suitable tangible media. As another example, transitory computer readable media can include signals on networks, in wires, conductors, optical fibers, circuits, or any suitable media that is fleeting and devoid of any semblance of permanence during transmission, and / or any suitable intangible media.

[0082] Referring to FIG. 7 A. a perspective view of a non-limiting example interventional device guide injection assembly 700 coupled to an ultrasound probe 710 is shown. Base 740 is shoyvn yvith ultrasound handle fixture 730 that provides detachable coupling to ultrasound probe 710. The injection assembly 700 may be attached to any ultrasound device, such as by being strapped onto an ultrasound probe 710 using the ultrasound handle fixture 730. Base 740 may include a mechanical support resting on the skin in order to minimize kick-back and improve needle insertion accuracy.

[0083] Referring to FIG. 7B, a side view of the interventional device guide injection assembly 700 of FIG. 7A is shown. In a non-limiting example, base 740 contains a motor to set the angle at which the interventional device, which may be a needle, will be inserted. In a non-limiting example, the interventional device may be at least one of a needle, dilator,Client. MIT 24998LJbreathing tube, chest tube, vascular catheter, urinary' catheter, drainage catheter, catheter with stent, epidural catheter, abscess drains, biliary catheters, nephrostomy tubes, suprapubic bladder catheters, gastronomic catheters, or other percutaneous enteric catheters. The interventional device may also include catheter-deliverable therapeutics, such as a blood clotting agent or drug. The base 740 may also contain a second drive motor to drive the interventional device to the desired depth. The motor may be controlled to vary the needle insertion speed at different insertion depths, e.g., the needle may be inserted relatively slowly through the skin to minimize kick-back and improve accuracy, and then inserted faster subsequently. In some configurations, the drive motor function may be replaced or augmented by a spring or any suitable method of storing mechanical energy, and an additional motor or other suitable method of mechanical actuation to enable injection into a subject. Cartridge 720 is detachably coupled to base 740 and may be configured for the intervention being performed. In non-limiting examples, cartridge 720 may include configurations to provide at least one of vascular access, access to an organ or body cavity, perform of cricothyrotomy, take a tissue sample, alleviate tension pneumothorax, administer epidural anesthesia, access a pericardial cavity, or estabhshan airway. Non-limiting example cartridge configurations are listed in Table 1 below.

[0084] Table 1 - Non-limiting example cartridge configurationsClient. MIT 24998LJ

[0085] Referring to FIG. 7C is a side view of the base and ultrasound probe fixture for the interventional device guide of FIG. 7B. Base 740 includes a drive motor 745 to set an insertion angle and / or depth for an interventional device held by cartridge slot 725 coupled by cartridge coupling 722. Advancement motor 747 may be included to advance an interventional device with activation by advancement control 755, which in a non-limiting example is a button. Electrical interface connector 752 may provide communication to an ultrasound imaging system or separate display system. User guidance signal 750 provide feedback to a user and may take the form or any display intending to direct the user in gross and / or precise placement of the device. In a non-limiting example, user guidance signal 750 includes an arrangement of LEDs. In some configurations, user guidance signal 750 may be coupled to the cartridge 720 and may be specific to the particular indication being treated.Client. MIT 24998LJ

[0086] Referring to FIG. 7D is a cross-section of a non-limiting example cartridge 720 compatible with the injection assembly 700 of FIG. 7B. Lead screw 760 may provide for actuation of base coupling 770 to couple the non-limiting example cartridge 720 to base 740 in FIG. 7B. Needle carriage 765 is shown as a non-limiting example of a needle cartridge application.

[0087] Referring to FIG. 8A, a perspective view of a non-limiting example interventional device guide integrated with an ultrasound probe is shown. Integrated interventional device guide 800 is shown being placed on a subject 810. The integrated interventional device guide 800 may include functionality similar to injection assembly 700 described above with integration with an ultrasound probe. The integrated interventional device guide 800 may be ultrasound guided, and may employ machine learning or artificial intelligence for identifying a target structure for penetration and guiding penetration of the target structure, in accordance with the present disclosure. The integrated ultrasound transducer may provide for excitation, for reading a source, for processing ultrasound signals, and the like. Integrated interventional device guide 800, may include onboard artificial intelligence algorithms, motors, associated drive circuitry, other electromcs / mechanics, and the like fit within a housing 805 for the integrated device guide 800. A cartridge, such as described herein, may be detachably coupled to integrated interventional device guide 800. In some configurations, the integrated interventional device guide 800 may be robotically controlled.

[0088] Referring to FIG. 8B is an exploded view of the integrated interventional device guide 800 and ultrasound probe of FIG. 8A is shown. Circuit boards 820 may provide for ultrasound guidance from ultrasound transducers 840, and may employ machine learning or artificial intelligence for identify ing a target structure for penetration and guiding penetration of the target structure, in accordance with the present disclosure. Battery’ 830 may provide power for the integrated device. One battery cell is shown in FIG. 8B, but it is to be appreciated that any number of battery cells may be used, such as two cells for extended life, or any other form of power supply. Drivetrain 850 may provide for independent needle or interventional device insertion and cannula insertion. Needle and cannula 870 may be inserted into a subject with motors 860.

[0089] Referring to FIG. 9 is perspective view of a non-limiting example cricothyrotomy cartridge 900 for use in accordance with the present disclosure. As indicated in Table 1 above, different clinical indications may require different types of needles or other hardware / drugs to be introduced into the body. In anon-limiting example, in the case of non-compressible hemorrhage, blood products may need to be rapidly introduced and a needleClient. MIT 24998LJsheath may provide a path of adequate diameter for rapid introduction of fluid. In another nonlimiting example, a catheter may need to be introduced, or a dilating element with larger lumen may be required. Each cartridge may be designed, and clearly labeled with, an intended application. In some configurations, the system may be capable of knowing which type of cartridge device is “plugged” into it. This information may be conveyed through electrical communication between the cartridge and the base, such as radio frequency or direct conducted signals, or through optical communication between the cartridge and the base, or through a mechanical keying specific to the cartridge / base assembly that indicates the cartridge type used, and the like. In a non-limiting example of a mechanical keying, the Femoral Artery / Vein Generation 1 cartridge of Table 1 could be configured such that it depresses a first button in the cartridge slot in the base, whereas the generation 2 cartridge in this family could be configured to depress a second button. In this manner, the base may distinguish between which cartridges have been inserted. In some configurations, the cartridge may be inside of the sterile surgical barrier with the base external the sterile barrier, such that communication of the cartridge type may be performed through the barrier to ensure safe, effective treatment.

[0090] Referring to FIGS. 10A-E, side views of inserting and removing a non-limiting example dilating component into a subject is shown. Some ty pes of cartridges shown in Table 1 may require more than a single step needle insertion process. In a non-limiting example, a cartridge may be configured to install a dilated lumen, which may include a multi-step process. In a non-limiting example, installing a breathing tube through the cricothyroid membrane may include a coaxial assembly consisting of a sharp center element for puncturing and initial path guidance in addition to a coaxial element for dilation and eventual passage of air, which may be introduced according to FIGS. 10A-E.

[0091] The sequence shown in FIGS. 10A-10E may be entirety automated by the motors or other mechanical actuation in the system, or may be a combination of automated actuation and human handling. Referring to FIG. 10A, a side views of inserting a non-limiting example dilating component 1010 into a subject is shown. In some configurations, a protector may be removed to insert a disposable version of the dilator 1010 to maintain sterility and safety.

[0092] Referring to FIG. 10B a side view of aligning a non-limiting example dilating component 1010 with the interventional device guide 1020 is shown. Needle 1030 may be deployed after device alignment, which may be coaxial with dilating component 1010. In some configurations, the receiving anatomy may be more sensitive to damage or additional mechanical guidance may be required for proper introduction of the larger diameter element.Client. MIT 24998LJIn such configurations, a “guide-wire’' device may be used to temporarily protrude from the tip of the inserted assembly, in a function similar to that of the guide-wire used in the Seidinger technique or modified (accelerated) Selding technique. The “guide-wire” device may be deployed between steps depicted in FIG. 10B and FIG. IOC.

[0093] Referring to FIG. 1 OC, a side view of advancing a non-limiting example dilating component 1010 into the subject is shown. Dilating component 1010 may be advanced over, and may be coaxial with, needle 1030. Dilating component 1010 may provide for expanded access into the subject after insertion. Referring to FIG. 10D, a side view of retracting the needle 1030 from the subject is shown. Referring to FIG. 10E, a side view of removing the interventional device guide 1020 is show where dilating component 1010 is retained in the subject and may be used for access from an interventional device.

[0094] Guidewire Placement Mechanism

[0095] The systems and methods described above for inserting a catheter in a blood vessel can follow' the standard Seidinger technique: 1) insert a hollow7needle in the vessel, 2) insert a guidewire through the needle into the vessel, 3) withdraw the needle, 4) insert a catheter over the guidewire (for a large catheter, a skin incision and dilator may be needed to enable this step), 5) withdraw the guidewire. The first three steps are both important and can be error-prone with which the systems and methods of the present disclosure assists. Accordingly, additional system and methods for inserting the guidewire, withdrawing the needle, and removing the AI-GUIDE device are described herein.

[0096] Referring to FIGS. 11 A-l 1 C, an interventional device guide injection assembly 1100 with a guidewire system 1102 including a guidewire advancement system 1104 is shown. In a non-limiting example, the guidewire system 1102 may be integrated with a cartridge 1120, such as cartridge 720 of FIG. 7B. Alternatively, the guidewire system may be reversibly attached to the cartridge 1120. In a non-limiting example, the guidewire system 1102 may be coupled to the cartridge 1120, wherein the guidewire system 1102 is positioned within or external to the cartridge 1120. The guidewire system 1102 further includes a tube 1106 containing the guidewire 1108. In a non-limiting example, the tube 1106 is made of polytetrafluoroethylene (PTFE). The tube may provide low resistance to the advancing guidewire 1108, minimal radius of curvature to decrease footprint while preventing kinking or permanent bending of the guidewire 1108, and visibility through the w alls of the tube 1106 to allow a user to visibly confirm wire advancement. In a non-limiting example, the guidewire may include optical or magnetic markers at known lengths that may be identified in imaging data for determining the degree of guidewire advancement into a vessel, or for determining theClient. MIT 24998LJplacement of the guidewire outside the body of the subject, in the target vessel, or outside the target vessel.

[0097] The interventional device guide injection assembly 1100 also includes a guidewire stabilizer 1110 removably coupled to the distal end of the guidewire system 1102 (configured to be adjacent to the surface of the subject while in use), which will be described in further detail below. The guidewire system 1102 and its components may be configured in the interventional device guide injection assembly 1100 with an ultrasound probe 1124, a handle fixture 1130 and a base (not shown). The ultrasound probe may be any one of the probes 210, 710 as previously described. The handle fixture 1130 may be handle fixture 730 of FIGS.7A-C as previously described. The base may be base 740 of FIGS. 7A-C as previously described. In a non-limiting example, the interventional device guide injection assembly 1100 may be in an open housing, as shown, enclosed. Alternatively, the guidewire system 1102, cartridge 1120, ultrasound probe 1124, handle fixture 1130, base, and any other components contemplated herein may be independent components reversibly attachable to each other.

[0098] FIG. 11B shows details of the guidewire advancement system 1104 of FIG.11 A. It includes an external gear 1112 configured to be rotated. The external gear 1112 may be rotated by a motor or manually by a user, such as with their thumb. In a non-limiting example, the external gear 1112 may provide tactile feedback to a user while the guidew ire is advanced. In anon-limiting example, the external gear 1112 is positioned so that the user can hold the device steady with both hands while advancing the guidewire. Arrow 1113 shows a clockwise rotation direction for advancing the guidewire. Spinning the gear in the opposite or counter-clockwise direction retracts the guidewire. As used herein, “advancing” refers to a translation out of the cartridge or towards the subject. “Retracting” refers to the translation into the cartridge or away from the subject. The external gear 1112 is mounted on a wheel housing 1114. The external gear 1112 engages the driving gear 1116, which drives driving wheel 1118 inside the guidewire advancement system 1104 (FIG. 11C). Driving wheel 1118 rotates in a clockwise direction 1117 upon clockwise rotation of the external gear 1112. The guidewire 1108 subsequently advances between the driving wheel 1118 and contact wheel 1122. In a nonlimiting example, the contact wheel is free spinning. The guidewire 1108 is positioned between the driving w heel 1118 and the contact wheel 1122. Upon rotation of the driving wheel 1118, the guidewire 1108 advances or retracts, causing the contact wheel to rotate in a direction opposite the driving wheel’s rotation direction. In a non-limiting example, one of the driving wheel 1118 or the contact wheel 1122 may include a potentiometer for determining the amount of advancement of the guidewire 1108. In an alternative embodiment, the external gear 1112Client. MIT 24998LJand driving wheel 1118 may rote in the opposite direction (i.e., counterclockwise) to advance the guidewire 1108. For example, the rotation of the external gear 1112 may depend on whether the left or right hand is used to rotate it.

[0099] In an alternative example, the guidewire advancement system 1104 includes a linear displacement means for advancing the guidewire 1108 in place of the rotatable external gear 1112. For example, the linear displacement means may include, but is not limited to, walking feed dogs to stepwise advance or retract the guidewire via a motor, a mechanical user button-press, or a spring-loaded repeating chuck that grasps and releases the guidewire to drive it with a mechanical button press.

[0100] In a non-limiting example, where the guidewire system 1102 contains a needle, the guidewire 1108 advances through the lumen of the needle.

[0101] In a non-limiting example, the interface between the driving wheel 1118 and contact wheel 1122 with the guidewire 1108 may permit purposeful slipping above a minimum force threshold as a safety mechanism to preclude further guidewire advancement when too much resistance is present.

[0102] Device Removal after Guidewire Placement

[0103] Referring now to FIGS. 12A-12D, the guidewire system 1102 from FIG. 11A may be secured on or within the cartridge 1220 (which may be any of the cartridges 720, 1120 as previously described). In a non-limiting example, the guidewire system 1102 may be integrated with the cartridge door 1222. The guidewire stabilizer 1110 from FIG. 11A comprises a clamp lever 1202 and clamp hub 1204 configured to interface with the guidewire system 1102 / cartridge 1120 and the surface of the subject’s skin. In a non-limiting example, clamp lever 1202 and clamp hub 1204 are used to remove the cartridge 1220 or guidewire system 1102 while holding the inserted guidewire 1108 in place. The guidewire stabilizer 1110 provides the following benefits while removing the cartridge 1220, guidewire system 1102, or interventional device guide injection assembly 1100 as a whole: Removing the assembly 1100 from the patient risks pulling the deployed guidewire 1108 out of the patient. To prevent this, the guidewire must be fixed in location relative to the patient as the assembly is withdrawn. Since the assembly is in close proximity to the skin surface during the procedure, it is difficult for a user to simply grab the wire with their fingers. Additionally, the wire is small and slippery making it hard to grasp with gloved fingers. The guidewire stabilizer 1110 grasps the guidewire 1108 projecting beyond the device and affords 1) good grip of the guidewire 1108 and 2) accessibility to the operator even when the assembly 1100 is in close proximity to the subject.

[0104] FIGS. 12B illustrates the guidewire system 1102 in a secured configuration,Client. MIT 24998LJwhile FIGS. 12C-12D show the removal mechanism of the cartridge 1220. Specifically, the cartridge 1220 includes a notch 1206 which is configured to receive a complementary shaped protrusion 1208 on the clamp lever 1202. When the protrusion 1208 occupies the notch 1206, the guidewire system 1102 is secured to the cartridge 1220 (FIG. 12B top). The clamp lever 1202 includes a ball valve 1210 at its distal end and is positioned within a distal end of the clamp hub 1204. The distal end of the clamp hub 1204 is a cup 1205 and configured to cup the ball valve 1210 (FIGS. 12B-D bottom). As used herein, ‘"cup” means to not fully enclose the cupped object. For example, the cup 1205 may partially enclose the ball valve 1210 such that the clamp lever 1202 can at least partially rotate. The ball valve 1210 and cup 1205 are removably attached to the distal end 1224 of the cartridge 1220 and aligned with an opening for needle, guidewire, or other interventional device advancement. In a secured coupling position between the lever 1202 and the cartridge 1220, a channel 1212 in the ball valve 1210 aligns with the opening at the distal end 1224 of the cartridge and an opening 1214 in the cup 1205 to allow' the guidewire 1108 to extend out of the cartridge 1220 and through the guidewire stabilizer 1110 towards the subject. In a non-limiting example, the guidewire 1108 extends out of the cartridge 1220 through a needle or other interventional device.

[0105] FIGS. 12C-12D show how the cartridge 1220 is removed leaving behind the guidewire stabilizer 1110 guidewire 1108. In a non-limiting example, removing the cartridge may also include removing one or more of the guidewire system and the rest of the interventional device guide). A user at least partially rotates the clamp lever 1202 towards the clamp hub 1204, thereby disengaging the protrusion 1208 from the notch 1206 (FIG. 12C top). The at least partial rotation alters the orientation of the ball valve 1210 and the channel 1212, thereby causing a misalignment of the channel 1212 with the opening 1214. As used herein, “misalignment” refers to the channel 1212 and opening 1214 being non-parallel relative to each other. At the greatest degree of misalignment, the channel 1212 and opening 1214 are non-continuous relative to each other. Misalignment of the channel 1212 and opening 1214 causes the guidewire 1108 that extends out of the hub and into the subject to bend and be held in place relative to the surface of the subject. In FIG. 12D, the cartridge 1220 is separated from the cup 1205 using one hand while holding the clamp hub 1204 with the guidewire 1108 against the skin with the other hand. In a non-limiting example, removing the cartridge 1220 may also include removing the guidewire system, and / or interventional device guide injection assembly.

[0106] After removal of the cartridge 1220, another interventional device may be fed over the guidewire 1108 for insertion into the subject.

[0107] The guidewire system 1102 described in FIGS. 11-12 provides severalClient. MIT 24998LJadvantages over standard manual guidewire placement or motorized guidewire placement. In a non-limiting example, the design affords a user the ability to control guidewire advancement while maintaining a two-handed grip on the device for stability. Moreover, the features described above provide tactile and visual feedback during guidewire advancement. Additionally, the removal mechanism does not require other stabilization tools to disengage the cartridge or device. Furthermore, the guidewire may be packaged within a modular cartridge or assistive device. These non-limiting aspects allow for medical nonspecialist to perform guidewire advancement and device removal as part of performing the Seidinger Technique.

[0108] The guidewire system described herein is non-limiting, and may include other guidewire advancement, stabilization, and cartridge detachment means. For example, springbased, motorized, or paddle and spool-based guidewire placement may provide alternative guidewire advancement techniques. Further, holding the guidewire during detachment of the cartridge from the stabilizer may be achieved by a scissor clamp method for horizontal compression or the Collett method for vertical compression.

[0109] The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.

Claims

Client. MIT 24998LJCLAIMS1. A system for placing a guidewire in a subject, comprising:a housing comprising:an ultrasound probe;a cartridge containing at least one interventional device;a guidewire system coupled to the cartridge comprising a guidewire and a guidewire placement system configured to at least one of advance or retract the guidewire through the interventional device;wherein the housing is configured to guide the interventional device and the guidewire system into a field of view (FOV) of the ultrasound probe; a non-transitory memory having instructions stored thereon; and a processor configured to access the non-transitory memory and execute the instructions.

2. The system of claim 1, wherein the guidewire system further comprises:an external gear, configured to be rotated, wherein the external gear is rotatable in at least one of a clockwise direction or counterclockwise direction; a driving gear in contact with the external gear, and configured to rotate based on a rotation of the external gear;a driving wheel in contact with the driving gear and configured to rotate based on a rotation of the external gear; anda contact wheel, wherein the guidewire is positioned between the driving wheel and the contact wheel and advances or retracts based on the rotation of the external gear and driving wheel.

3. The system of claim 1, further comprising a guidewire stabilizer removably coupled to the guidewire system, the guidewire stabilizer comprising:a lever including a valve, wherein the valve includes a channel configured to advance the guidewire therethrough, retract the guidewire therethrough, or hold the guidewire in place relative to the subject after insertion into the subject; anda clamp hub including a cup, wherein the cup includes an opening to at least one of advance or retract the guidewire therethrough and is configured to cup the valve, wherein the valve at least partially rotates in the clamp hub to align the channel with theClient. MIT 24998LJopening for advancement or retraction of the guidewire or to misalign the channel and the opening to bend and hold the guidewire in place.

4. The system of claim 3, wherein the lever includes a protrusion configured to reversibly engage the cartridge via a notch in the cartridge.

5. The system of claim 3. wherein the guidewire stabilizer is removably attached to the cartridge.

6. The system of claim 1, wherein the interventional device includes a needle, vascular catheter, urinary catheter, drainage catheter, catheter with stent, epidural catheter, abscess drains, biliary catheters, nephrostomy tubes, suprapubic bladder catheters, gastronomic catheters, or other percutaneous enteric catheters.

7. The system of claim 6, wherein the interventional device is configured to provide at least one of vascular access, access to an organ or body cavity, perform cricothyrotomy, alleviate pneumothorax, administer epidural anesthesia, or access a pericardial cavity.

8. The system of claim 1. wherein the processor accessing the non-transitory memory and executing the instructions is caused to:access image data acquired from the subject using the ultrasound probe, wherein the image data include at least one image of a target structure of the subject;determine, from the image data, a location of the target structure within the subject;determine an insertion point location for the interventional device based upon the location of the target structure and guide placement of the ultrasound probe to position the guide system at the insertion point location; andtrack the interventional device from the insertion point location to the target structure.Client. MIT 24998LJ9. The system of claim 8, wherein the processor is further caused to determine at least one of an angle for the interventional device from the insertion point location to the target structure, a rotational angle for the ultrasound probe with respect to the subject; or an insertion distance from the insertion point location to the target structure.

10. The system of claim 9, further comprising a display system and wherein the processor is further configured to cause the display system to show at least one of the angle for the interventional device, the insertion point location, the location of the target structure, or the insertion distance.

11. The system of claim 10, wherein the display system provides one of an indicator of the insertion point location projected proximate to the target structure, or an indicator of the ultrasound probe position at the insertion point location by an illumination display coupled to the system.

12. The system of claim 8, wherein the processor is further caused to track the interventional device from the insertion point location to the target structure and provide real-time feedback to a user based on tracking the interventional device.

13. The system of claim 8. wherein the processor is further caused to segment the image data based upon appearance of the target structure to determine at least one of the location of the target structure or an identity of the target structure.

14. The system of claim 8, wherein the target structure is one of an artery, a vein, a femoral artery, a femoral vein, a jugular vein, a peripheral vein, a subclavian vein, a cephalic vein, a basilic vein, an airway, a lumen, a luminal organ, a body cavity, a fluid filled anatomic space, a location requiring biopsy, a breast, a kidney, a lymph node, a spinal canal, a location requiring nerve block, a peritoneal space or a pleural space.

15. The system of claim 8, wherein the processor is configured to receive a plurality of images of the target structure of the subject acquired in real time to access the image data.Client. MIT 24998LJ16. The system of claim 15, wherein the plurality of images include a plurality of views of the target structure, and wherein the processor is configured to assess the plurality of views to identify a critical structure in the subject and identify a location on the subject where the interventional device reaches the target structure from the insertion point location without penetrating the critical structure in the subject.

17. The system of claim 16, wherein the critical structure includes at least one of a bone, an unintended blood vessel, a non-target organ, or a nerve.

18. The system of claim 16, wherein the plurality of images include images at a plurality of different timeframes.

19. The system of claim 1, wherein housing further includes a guide system configured to detachably couple to the ultrasound probe with an ultrasound handle fixture.

20. The system of claim 19, wherein the guide system is coupled to the ultrasound probe by integration with the ultrasound probe in the housing.

21. The system of claim 19, wherein the guide system includes a power supply.

22. The system of claim 19, wherein the guide system is configured to guide the interventional device automatically.

23. A method for placing a guidewire in a subject using the system of any one of claims 1-22, comprising:acquiring, via the ultrasound probe, ultrasound imaging data;locating, via the processor, a vessel of interest in the ultrasound imaging data; determining, via the processor, a needle insertion point;controlling, via the processor, insertion of the needle into the vessel; inserting a guidewire through the needle into the vessel; andadvancing the guidewire into the vessel.

24. The method of claim 23, further comprising withdrawing the needle from the vessel over the guidewire.Client. MIT 24998LJ25. The method of claim 23, further comprising stabilizing the guidewire relative to the subject.

26. The method of claim 25, wherein stabilizing the guidewire includes using a guidewire stabilizer to bend and hold the guidewire in place relative to the subject.

Images