Systems and methods for supervised remote imaging guided intervention

Abstract

A method for remote intervention of a subject includes acquiring an image of a region of interest of the subject using an interventional device and an image acquisition system located on the subject. The region of interest includes a target structure, and the subject is located at a first site. The method further includes analyzing, using an image analysis module, the acquired image to identify and mark a target structure in the region of interest, and transmitting the marked image from the first site to a second site for expert review. The second station is remote from the first station. The method further includes receiving, at the first site, a command signal from the second site, where the command signal is generated based on expert review of the tagged image, and the command signal is configured to control an action of the interventional device. In some embodiments, the method may further include analyzing the acquired image to determine a path to the blood vessel that avoids the key structure.

Description

Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Serial No. 63 / 420,900, filed October 31, 2022, and entitled "Systems and Methods for Supervised Remote Ultrasound - Guided Interventions", which is incorporated herein by reference in its entirety. Statement Regarding Federally Sponsored Research

[0002] This invention was made with government support under FA8702 - 15 - D - 00001 awarded by the U.S. Army and the Defense Health Agency. The government has certain rights in the invention. Background of the Invention

[0003] There is growing interest and investment in promoting home - based healthcare models, in which healthcare services are provided primarily via remote interactions (i.e., telemedicine). These programs, often referred to as "hospital - at - home", are being rolled out across major healthcare systems in the United States and are aimed at reducing hospital stays by providing better and longer home care, thereby improving care and reducing costs. Summary of the Invention

[0004] According to an embodiment, a method for supervised remote intervention for a subject includes using an interventional device and an image acquisition system located on the subject to acquire an image of an area of interest of the subject. The area of interest includes a target structure, and the subject is located at a first site. The method further includes using a machine - learning network to analyze the acquired image to identify and label the target structure in the area of interest and transmitting the labeled image from the first site to a second site for expert review. The second site is remote from the first site. The method further includes receiving, at the first site, a command signal from the second site, where the command signal is generated based on the labeled image and is configured to control the action of the interventional device.

[0005] In some embodiments, analyzing the acquired image further includes: analyzing the acquired image to detect critical structures that the needle should avoid, and calculating a path from the surface of the subject such that the needle avoids the critical structures and intersects the target structure. In some embodiments, the method further includes causing deployment of the needle of the interventional device based on a command signal. In some embodiments, the method further includes enabling the interventional device to deploy based on a command signal and causing deployment of the needle of the interventional device. In some embodiments, the image analysis module is implemented as a machine learning network. In some embodiments, the interventional device is a vascular access device configured for blood drawing. In some embodiments, the interventional device is a vascular access device configured for intravenous drug delivery. In some embodiments, the interventional device includes an ultrasound transducer and the image acquisition system is an ultrasound system. In some embodiments, the interventional device includes an optical image sensor and the image acquisition system is an optical imaging system. In some embodiments, transmitting the labeled image from a first site to a second site for expert review includes: transmitting the labeled image from the first site to the second site via a communication network. In some embodiments, the interventional object is a vascular access device and the target structure is a target blood vessel, and using the image analysis module to analyze the acquired image to identify and label the target structure in the region of interest includes: determining one or more of the position of the target blood vessel, the centroid depth of the target blood vessel, and the diameter of the target blood vessel. In some embodiments, the method further includes determining whether the target blood vessel is suitable for needle insertion based on the determined diameter of the target blood vessel. In some embodiments, the interventional device is configured to be positioned around the subject's arm and the interventional device may include a cuff configured to be positioned around the subject's arm. In some embodiments, the method further includes monitoring the interventional device based on the images acquired using the interventional device and the image acquisition system to determine changes in the position of the vascular access device.

[0006] According to another embodiment, a system for remote intervention for a subject includes an interventional device positioned on the subject. The interventional device includes an image sensor, a needle, and a robotic assembly that includes a needle positioning system configured to automatically adjust the position of the needle relative to the image sensor to align the needle with a target structure in the region of interest of the subject. The system further includes an image acquisition system coupled to the image sensor of the interventional device, and an image analysis module coupled to the interventional device and the image acquisition system. The image analysis module is configured to analyze an image of the region of interest of the subject to identify and label the target structure and to determine a path to the blood vessel that avoids critical structures. The image of the region of interest is acquired using the image sensor and the image acquisition system.

[0007] In some embodiments, the image analysis module is a machine learning network. In some embodiments, the needle positioning system is further configured to automatically adjust the position of the needle to align the needle with the target insertion point of the target structure and avoid critical structures. In some embodiments, the interventional device is a vascular access device and further includes a cuff configured to be positioned around the subject's arm. In some embodiments, the interventional device is a vascular access device configured for blood drawing and further includes one or more vials. In some embodiments, the interventional device is a vascular access device configured for intravenous drug delivery. In some embodiments, the image sensor is a transducer array and the image acquisition system is an ultrasound system. In some embodiments, the image sensor is an optical image sensor and the image acquisition is an optical imaging system. In some embodiments, the interventional service is a vascular access device, the target structure is a target blood vessel, and the image analysis module is further configured to determine one or more of the position of the target blood vessel, the centroid depth of the target blood vessel, and the diameter of the target blood vessel. In some embodiments, the interventional device is a vascular access device configured to be positioned around the subject's arm and constrict around the subject's arm to increase the diameter of the target blood vessel.

[0008] According to another embodiment, a method for performing remote intervention on a subject includes: using an interventional device and an image acquisition system located on the subject to acquire an image of an area of interest including a target structure of the subject, using an image analysis module to analyze the acquired image to identify and label the target structure in the area of interest, and using the image analysis module to generate a command signal that is generated based on the labeled image and is configured to control the action of the interventional device. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be described below with reference to the drawings, in which like reference numerals represent like elements.

[0010] Figure 1 is a block diagram of a system for supervised remote interventional surgery according to an embodiment;

[0011] Figure 2 illustrates a method for supervised remote interventional surgery according to an embodiment;

[0012] Figure 3 illustrates an example supervised remote phlebotomy system according to an embodiment;

[0013] Figure 4A illustrates a top view of an example remote vascular access device according to an embodiment;

[0014] Figure 4B illustrates according to an embodiment Figure 4ARear and side views of an exemplary remote vascular access device;

[0015] Figure 5 is a block diagram of an exemplary computer system according to an embodiment; and

[0016] Figure 6 is a schematic diagram of an exemplary ultrasound system according to an embodiment. DETAILED DESCRIPTION

[0017] The present disclosure describes systems and methods for supervised remote imaging-guided interventions. In some embodiments, the described systems and methods can extend the capabilities of in-home services (or point-of-care services located in other non-hospital or non-laboratory environments, e.g., pharmacy clinics) to include supervised remote interventions for applications including, but not limited to, remote vascular access (e.g., venipuncture, intravenous delivery of drugs, or IV placement), remote injection into muscle, remote injection of drugs into body cavities, and remote injection or placement of interventional devices into organs such as the liver, brain, and kidney. In some embodiments, the described systems and methods allow for remote expert supervision of remote interventional procedures on a subject. In some embodiments, the described systems and methods can allow for remote supervision of access to a subject's arterial system for the purpose of performing remotely controlled intravascular procedures (or interventions). Thus, in some embodiments, home-based patients and caregivers (e.g., family members) can use the described systems and methods to, for example, sample blood or deliver intravenous drugs.

[0018] For the purposes of the present disclosure and the appended claims, the term "real-time" or related terms are used to refer to and define the real-time performance of a system, which is understood to be performance affected by the operational deadline from a given event to the system's response to that event. For example, real-time extraction and / or display of such data based on acquired image data can be triggered and / or executed simultaneously, with or without interruption of the acquisition process.

[0019] Figure 1FIG. 0 is a block diagram of a system for supervised remote interventional surgery according to an embodiment. System 100 may include a computing system 106 located at an expert site 102 (e.g., an office, a hospital), and a computing system 110, an image acquisition system 112, and a supervised remote interventional device 114 located at a remote site 104 (e.g., a subject's home or other non-hospital or non-laboratory environment). As used herein, the remote site 104 may be the location of the subject, and in some embodiments, may be the location of a caregiver, and the expert site 102 may be the location of an individual (such as, for example, a doctor, a phlebotomist, a nurse, etc.) with expertise (i.e., an expert) in image interpretation and interventional surgery (such as, for example, for vascular access). In some embodiments, the computer system 106 and the computer system 110 may be any general-purpose computing system or device, such as a personal computer, a workstation, a cellular phone, a smart phone, a laptop computer, a tablet computer, etc. Thus, the computer system 106 and the computer system 110 may include any suitable hardware and components capable of performing various processing and control tasks according to aspects of the present disclosure. For example, the computer system 106 and the computer system 110 may include programmable processors or combinations of programmable processors, such as a central processing unit (CPU), a graphics processing unit (GPU), etc. In some embodiments, the computer system 106 and the computer system 110 may be configured to execute instructions stored in a non-transitory computer-readable medium. In some embodiments, the computer system 106 may include a user interface 118, and the computing system 110 may include a user interface 120. The user interface 118 and the user interface 120 may include, for example, a display and one or more input devices (e.g., a keyboard, a mouse, a touch screen).

[0020] The computing system 106 at the expert site 102 and the computing system 110 at the remote site 104 can communicate via the communication network 108. In an embodiment, the expert site 102 and the remote site 104 are located at positions far from each other, such as different positions in the same building, different buildings in the same city, different cities, or other different positions where the expert at the expert site 102 cannot physically access the subject or the remote vascular access device 114. In some embodiments, the computing system 106 and the computing system 110 can be configured to include telepresence capabilities (such as software applications, cameras, monitors, speakers, and microphones), and are configured to provide audio and video communications (such as telepresence, teleconferencing, video conferencing) between the expert at the expert site 102, the patient at the remote site 104, and in some embodiments, the caregiver. In some embodiments, the expert at the expert site 102 can use the computing system 102 to communicate with the patient (and caregiver) via the computing system 110 at the remote site 104, and supervise and / or implement the actions of the supervised remote intervention device 114, such as drawing blood from the subject, delivering intravenous drugs to the subject, placing an IV for the subject, or remotely placing an arterial access needle, sheath, or wire for the subject. For example, a video conference can be established between the computing system 106 at the expert site 102 and the computing system 110 at the remote site 104, so that the expert at the expert site 102 can view the patient, and in some embodiments, the caregiver at the remote site 104, the expert at the expert site 102, and the patient / caregiver at the remote site 104 can communicate via audio and video.

[0021] In some embodiments, the communication network 108 can be any suitable communication network or combination of communication networks. For example, the communication network 108 can include a Wi-Fi network (which can include one or more wireless routers, one or more switches, etc.), a peer-to-peer network (such as a Bluetooth network), a cellular network (such as a 3G network, 4G network, 5G network, etc. that conforms to any suitable standard (such as CDMA, GSM, LTE, LTE Advanced, WiMAX, etc.)), a wired network, and so on. In some embodiments, the communication network 108 can be a local area network, a wide area network, a public network (such as the Internet), a private or semi-private network (such as a corporate or university intranet), any other suitable type of network, or any suitable combination of networks. Figure 1 The illustrated communication links 116 can each be any suitable communication link or combination of communication links, such as a wired link, an optical fiber link, a Wi-Fi link, a Bluetooth link, a cellular link, and so on.

[0022] At remote site 104, computing system 110 may be coupled to and communicate with image acquisition system 112 and supervised remote intervention device 114. Remote intervention device 114 may be configured for various types of remote intervention, including deploying a needle (e.g., for injection) into a target anatomical or target structure of a subject. For example, in some embodiments, remote intervention device 114 may be a vascular access device removal device (e.g., for venipuncture, intravenous delivery of a drug, or IV placement), a remote intervention device for injecting (e.g., a drug) into muscle, a remote intervention device for injecting a drug into a body cavity, or a remote intervention device for injecting or placing another intervention device into an organ such as, for example, the liver, brain, and kidney. In some embodiments, the target structure of the subject may include, for example: arteries, veins, femoral arteries, femoral veins, jugular veins, peripheral veins, subclavian veins, airways, lumens, luminal organs, body cavities, fluid-filled anatomical spaces, locations requiring biopsy, breasts, kidneys, lymph nodes, spinal canals, locations requiring nerve blocks, peritoneal spaces, or pleural spaces. Although Figure 1 the following description may refer to a remote vascular access device for a remote intervention device, it should be understood that other types of remote intervention devices configured to target other structures (or anatomical structures) of the subject other than blood vessels may be utilized in system 100.

[0023] In some embodiments, the remote intervention device 114 (e.g., a remote vascular access device) may be configured as an "armband" or "cuff"-type robotic assembly that may be positioned on or attached to the arm between the subject's shoulder and wrist (e.g., proximal or distal to the subject's elbow) to insert a needle into a target blood vessel (or other target structure) of the subject to, for example, draw blood or deliver an intravenous drug. In some embodiments, the remote intervention device 114 may be configured to be positioned on other regions of the subject (e.g., other body parts). In some embodiments, the remote intervention device 114 may include, for example, one or more image sensors (e.g., an ultrasound transducer array), a needle, one or more vials, a robotic assembly or system for performing needle positioning and insertion, and a needle actuation controller. The one or more image sensors may be coupled to an image acquisition system 112 to acquire and generate images of the region of interest of the subject (e.g., the proximal or distal region of the elbow) to identify the target structure (e.g., the target blood vessel) for needle insertion. In some embodiments, the one or more image sensors may be ultrasound transducers incorporated into the "armband" assembly, and the image acquisition system may be an ultrasound system. Although the following description will relate to embodiments that utilize ultrasound technology, it should be understood that other imaging technologies such as, for example, video or optical imaging may be utilized. Thus, the one or more image sensors may be suitable image sensors for the imaging technology being used, e.g., a camera for video imaging or one or more optical image sensors for optical imaging. Additionally, the image acquisition system 112 may be a suitable imaging system for the imaging technology being implemented. In some embodiments, the remote vascular access device 114 may be positioned on or attached to the arm of the subject (or other region or area of the subject) such that the target structure (e.g., the blood vessel) is within the field of view of the one or more image sensors. The one or more needles provided in the remote intervention device 114 may be of a suitable size for the particular application of the remote intervention device 114 (e.g., blood draw, intravenous drug delivery). In some embodiments, for blood draw, the robotic assembly may be configured to actuate the needle, e.g., cause deployment of the needle to insert the needle into the target blood vessel and fill one or more vials in the remote intervention device with blood. In some embodiments, the robotic assembly may be configured to actuate the needle, e.g., cause deployment of the needle to insert the needle into the target blood vessel and deliver a drug from one or more vials to the subject. As described above, the supervised remote intervention device 114 may also include a needle actuation controller. In some embodiments, the needle actuation controller may be incorporated into the "armband" or "cuff" assembly, and in some embodiments, the needle actuation controller may be the controller 126, which is coupled to the supervised remote intervention device 114 via, for example, a cable or wire.For example, the controller 126 can be incorporated in a handheld device (e.g., the controller 318 shown in Figure 3 or the controller 434 shown in Figure 4A ). In some embodiments, the remote intervention device 114 or the controller 126 can include a user input (e.g., a button) that can be used by a subject or a caregiver at the remote site 104 to initiate needle deployment.

[0024] An image analysis module can also be provided, which can be configured to analyze the images acquired by the supervised remote intervention device 114 to identify the target structure (e.g., the target blood vessel), and segment or label the acquired images and the target structure (e.g., the target blood vessel). For example, in some embodiments, the image analysis module 124 can be implemented in the image acquisition system 112 at the remote site 104, and in some embodiments, the image analysis module 122 can optionally be implemented on the computer system 110 at the remote site 104. In some embodiments, the image analysis modules 122, 124 can be implemented as trained machine learning networks (e.g., neural networks), AI routines, or image analysis algorithms. In some embodiments, the image analysis modules 122, 124 can be configured to determine the location of the target structure (e.g., the target blood vessel) and various characteristics of the structure. For example, for the target blood vessel, characteristics such as the centroid depth, diameter, and position along the image sensor (e.g., the ultrasound array) can be determined. The segmentation of the target structure (e.g., the target blood vessel) can be based on machine learning of the morphological and spatial information in the images of the region of interest and the target structure (e.g., ultrasound images). In some embodiments, a neural network can be trained to learn features at multiple spatial and temporal scales. In one example, the blood vessel of interest can be distinguished based on the shape and / or appearance of the blood vessel wall, the shape and / or appearance of the surrounding tissue, etc. Characteristics such as blood vessel diameter can be used to determine whether the blood vessel is suitable for needle insertion. As described above, in some embodiments, the image analysis modules 122, 124 for analyzing the acquired image(s) to identify the target structure and segment or label the acquired image(s) and the target structure can be implemented as AI routines or image analysis algorithms (or modules). Advantageously, the machine learning network, AI algorithm, or image analysis algorithm can be implemented at the remote site 104, and thus can be applied to the images acquired locally from the subject. In some embodiments, the insertion point can be determined based on the determined location of the target structure, and the depth and path of the needle of the remote intervention device 114 from the surface of the subject to the target structure can be calculated. In addition, the image analysis modules 122, 124 can also be configured to analyze the acquired one or more images to detect critical structures that the needle should avoid, and calculate, for example, the path from the surface of the subject (e.g., the skin) to the target structure such that the needle avoids the critical structures and intersects the target structure.

[0025] The labeled (or annotated) images of the regions of interest and target structures (e.g., target blood vessels) generated by the image analysis modules 122, 124 can be transmitted to the computing system 106 at the expert site 102 and displayed to the expert (e.g., on the display of the user interface 118). The expert can advantageously review the labeled images and determine, for example, whether the needle of the remote intervention device 114 is correctly positioned to insert the needle into the target structure (e.g., target blood vessel) of the subject. If the needle is correctly positioned, the expert can provide user input to the computing system 106 (e.g., via the user interface 118) to generate a command signal. In some embodiments, the command signal can be configured to enable (or “arm”) the needle insertion function on the remote intervention device 114. In some embodiments, the command signal can be configured to activate the remote intervention device 114 and cause the deployment of the needle to insert the needle into the target structure, for example. The command signal can be transmitted to the computing system 110 and the remote intervention device 114 at the remote site 104. In some embodiments where the command signal is configured to enable the needle injection function, the expert can also provide instructions to the subject or caregiver at the remote site 104 to initiate the needle deployment, for example, by pressing a button on the remote intervention device 114 or the controller 126. The robotic components (e.g., the needle insertion system and / or the needle actuation controller) can then be used to automatically deploy the needle to insert the needle into the target structure (e.g., target blood vessel). If the needle of the remote vascular access device 114 is not correctly positioned, the expert can provide instructions to the subject or caregiver to adjust the position of the remote intervention device 114 on the subject (e.g., on the subject's arm or other area). The remote intervention device 114 and the image acquisition system 112 can then be used to acquire an image of the region of interest at the new position and can process the image (e.g., using the image analysis modules 122, 124) to identify and label the target structure. The expert can then review the labeled image for the new position and determine whether to enable the needle injection function of the remote intervention device 114 or cause the deployment of the needle of the remote intervention device 114 (i.e., determine whether the needle is correctly positioned). In some embodiments, the image analysis modules 122, 124 and the annotated images can be unsupervised, i.e., expert review and validation may not be required. In some embodiments, the image analysis modules 122, 124 and the annotated images can be supervised by someone with less expertise than an expert. In some embodiments, the image analysis modules 122, 124 (instead of an individual) can be used (and configured) to automatically determine whether the needle of the remote intervention device 114 is correctly positioned to insert the needle into the target structure of the subject.If the needle is properly positioned, the image analysis modules 122, 124 can generate command signals, for example, to enable (or "arm") the needle insertion function on the remote intervention device 114, or to cause deployment of the needle of the remote intervention device 114, for example, to insert the needle into a target blood vessel.

[0026] In some embodiments, the image analysis modules 122, 124, the image sensors in the supervised remote intervention device 114, and the image acquisition system 112 can be configured to monitor the position of the remote intervention device 114 (e.g., the needle) in real time and determine, for example, whether the remote intervention device 114 has moved or changed position during the transmission of the marked image from the remote site 104 to the expert site 102 (and reviewed by the expert) and before the remote site 104 receives a command signal from the expert site 102, or between receiving a command signal at the remote site 104 and the user initiating deployment of the needle. This feature can be beneficial for patient safety and can be used to mitigate, for example, communication network time delays and motion artifacts. For example, there may be a delay in the communication of data and images over the communication network 108 between the remote site 104 and the expert site 102. During the communication delay, the subject may move, causing a shift in the position of the remote intervention device 114 (e.g., the needle). By monitoring the position of the remote intervention device 114 in real time, the system and method can disable the needle injection function until it is determined whether the new position of the remote intervention device 114 is suitable for needle injection or whether the remote intervention device 114 should be repositioned on the subject's arm. In some embodiments, the expert at the expert site 102 may wish to select a target different from the target identified by the image analysis module. In some embodiments, if communication is lost between the expert site and the remote site, the various elements of the system at the remote site can be configured to disable the needle injection function.

[0027] In some embodiments, the robotic assembly (or system for performing needle positioning and insertion) and the controller can be configured to allow adjustment of the positioning of the needle within the remote intervention device 114. In some embodiments, the robotic assembly of the remote intervention device 114 can include mechanisms for automatically adjusting the angle of the needle relative to the surface of the subject. In some embodiments, the robotic assembly can advantageously be configured to provide additional degrees of freedom for the needle, which can advantageously allow for automatic fine-tuning of the position of the needle relative to the target structure (e.g., the target blood vessel) and the appropriate insertion point. For example, in some embodiments, the robotic assembly can be configured to include a mechanism (e.g., a needle translation track) that allows the translational position of the needle to be automatically adjusted along an image sensor (e.g., an ultrasound array). The additional degrees of freedom can enable the needle to slide on the image sensor (e.g., along the needle translation track) for use in a "fine positioning" step prior to needle insertion. This feature can be advantageous by enabling a user with limited dexterity (e.g., the subject or a caregiver) to use the remote intervention device. Thus, the user only needs to position the remote intervention device such that the target structure is within the field of view of the image sensor (e.g., within approximately 4 cm for an ultrasound transducer).

[0028] Figure 2 A method for supervised remote vascular access according to an embodiment is shown. Figure 2 The process shown is described below as being performed by a system 100 for supervised remote vascular access as shown in Figure 1 Although the blocks of the process are shown in a particular order, in some embodiments, one or more blocks can be performed in an order different from that shown in Figure 2 or can be bypassed. Although Figure 1 the following description refers to the remote vascular access device as the remote intervention device and the target blood vessel as the target structure, it should be understood that other types of remote intervention devices and target structures (or anatomical structures) of the subject, such as those discussed above, can be used in the Figure 2 process.

[0029] At block 202, a remote intervention device 114 (e.g., a remote vascular access device) can be positioned on a subject at a remote site 104. For example, a subject or a caregiver of the subject can attach the remote vascular access device to the subject's arm such that an image sensor in the remote vascular access device can acquire an image of the region of interest. In some embodiments, for needle insertion (e.g., for blood collection or intravenous drug delivery), the remote vascular access device can be configured as a "armband" or "cuff" that can be positioned on the arm between the subject's shoulder and wrist (e.g., proximal or distal to the subject's elbow). In some embodiments, the remote vascular access device can be positioned on or attached to the subject's arm such that a target structure (e.g., a target blood vessel) is within the field of view of the (one or more) image sensors of the remote vascular access device. At block 204, image data (or (one or more) images) of the region of interest can be acquired using, for example, the (one or more) image sensors in the remote vascular access device and an image acquisition system 112 coupled to the (one or more) image sensors. In some embodiments, the image sensor can be an ultrasound transducer incorporated in the remote vascular access device, and the image acquisition system 112 can be an ultrasound system (e.g., a portable ultrasound system). As described above, in some embodiments, other imaging techniques, such as, for example, video or optical imaging, can be utilized. Thus, the (one or more) image sensors and the image acquisition system 112 can be the appropriate (one or more) image sensors and imaging systems for the imaging technique implemented.

[0030] At block 206, the acquired image data (or (one or more) images) can be analyzed to identify a target structure (e.g., a target blood vessel) in the region of interest and segment and / or label the target structure (e.g., the target blood vessel) in the region of interest. In some embodiments, as described above with respect to Figure 1As discussed, image analysis modules 122, 124 (e.g., trained machine learning networks (e.g., neural networks), AI routines, or image analysis algorithms) can be used to analyze the acquired image data to identify and label the target blood vessels. In some embodiments, image analysis modules 122, 124 can be configured to determine the location of the target blood vessels and various vessel characteristics, such as, for example, the centroid depth, diameter, and location along the image sensor (e.g., ultrasound array) of the blood vessels. In some embodiments, the insertion point can also be determined based on the location of the target blood vessel (e.g., using image analysis modules 122, 124), and the depth and path of the needle of the remote vascular access device 114 from the surface of the subject to the target blood vessel can be calculated. Additionally, in some embodiments, one or more of the acquired images can be analyzed (e.g., using image analysis modules 122, 124) to detect critical structures that the needle should avoid, and the path, for example, from the surface of the subject (e.g., skin) to the target blood vessel can be calculated such that the needle avoids the critical structures and intersects the target blood vessel.

[0031] At block 208, the labeled or annotated (one or more) images can be transmitted from the remote site 104 (or the location of the subject) to the expert site 102 for review by an expert (e.g., doctor, phlebotomist, nurse, etc.). In some embodiments, the labeled images can be transmitted from the computing system 110 at the remote site 104 to the computing system 106 at the expert site 102 via the communication network 108. In some embodiments, the labeled images can be displayed to the expert, for example, using a display of the computing system 106 at the expert site 102 (e.g., the display of the user interface 118). The expert can then review the labeled images to determine whether the needle of the remote vascular access device is correctly positioned to continue with needle insertion into the target structure (e.g., the target blood vessel). At block 210, if the needle placement is incorrect, the process can return to block 202, and the subject or caregiver can adjust the position of the remote vascular access device and thus the position or placement of the needle of the remote vascular access device relative to the target blood vessel. Image acquisition and analysis at blocks 204 and 206 can then be performed on the new position of the needle (and the remote vascular access device). In some embodiments, the annotated images can be unsupervised, i.e., expert review and validation may not be required. In some embodiments, the annotated images can be supervised by someone with less expertise than an expert. In some embodiments, image analysis modules 122, 124 (instead of an individual) can be used to determine whether the needle of the remote vascular access device is correctly positioned to insert the needle into the target blood vessel of the subject and generate a command signal.

[0032] If, at block 210, the needle is in the correct position, a command signal (e.g., generated by computing system 106) from the expert site 102 can be received at the remote site 104. In some embodiments, the command signal can be configured to enable (or “arm”) the needle insertion function of the remote vascular access device. In some embodiments, the command signal can be configured to activate the remote vascular access device and cause deployment of the needle, e.g., to insert the needle into a target structure (e.g., a target blood vessel). For example, an expert at the expert site 102 can provide user input (e.g., via user interface 118) to the computing system 106 to generate the command signal, and then the command signal can be transmitted to the computing system 110 and the remote vascular access device 114 at the remote site 104. At block 214, the remote intervention device 114, e.g., the remote vascular access device, can be controlled based on the received command signal. In some embodiments, deployment of the needle can be initiated to insert into the target structure (e.g., the target blood vessel). For example, once the needle function is enabled based on the command signal, a subject or caregiver can press a button on the remote vascular access device (or controller 126) to initiate needle deployment (or actuation). In another example, the command signal can cause deployment of the needle in the remote vascular access device, e.g., to inject the needle into the target blood vessel.

[0033] As described above, in some embodiments, the remote intervention device (e.g., the remote vascular access device) can be configured to draw blood from a subject. Figure 3 An example supervised remote phlebotomy system according to an embodiment is shown. In Figure 3 this, a subject (e.g., a patient) 306 and a caregiver 308 located at a remote site 304 (e.g., the subject's home or other non-hospital or non-laboratory environment) and an expert 310 (e.g., a doctor, phlebotomist, nurse, etc.) located at an expert site 302 (e.g., an office, a hospital, a home workstation, etc.) can communicate via, e.g., a video conference over a communication network (e.g., Figure 1 the communication network 108 shown). In some embodiments, the expert 310 can supervise the subject 306 and the caregiver 308 while performing phlebotomy on the subject 306. Figure 3The following discussion describes an example workflow for supervised remote venipuncture. The workflow and enabling software and devices can advantageously provide a home-based (e.g., home hospital) point of care for blood collection. In some embodiments, a doctor may determine that a subject 306 (e.g., a patient) needs a blood sample collected (e.g., for analysis). For example, a doctor may determine the need for a blood sample from subject 306 during an outpatient visit or during a teleconference visit. If a blood sample is needed, the doctor may order a supervised remote venipuncture "kit" to be sent to subject 306 at home (e.g., remote site 304). In some embodiments, the remote venipuncture kit may include a remote vascular access device 316 in the form of a remote venipuncture device, which may include an empty pre-loaded blood vial, a controller 318 for the remote venipuncture device 316 (e.g., a handheld controller), a trained machine learning network for image analysis, a portable image acquisition system (e.g., a portable ultrasound system), instructions for use, and an appropriate sample return container (e.g., pre-paid for shipping). Once the remote venipuncture kit is received, a caregiver 308 of subject 306 can open the kit and use a computer system 314 at the remote site 304 to connect, for example via a video conference, to a computer system 312 of an expert 310 at an expert site 302. In some embodiments, subject 306 may perform the remote blood collection themselves rather than with the help of caregiver 308.

[0034] The expert 310 (e.g., a doctor, nurse, phlebotomist, etc.) may guide subject 306 or caregiver 308 through a setup process, which may include, for example, sterilization, local anesthesia (if needed), and positioning the remote venipuncture device 316 generally on subject 306 (e.g., on the subject's arm). In some embodiments, as discussed above with respect to Figure 1 and below with respect to Figure 4A and Figure 4BAs further discussed, the remote venipuncture device 316 can be configured to perform "fine-tuning" of the position of the needle in the remote venipuncture device 316 to precisely position the needle relative to the target blood vessel. The expert 310 can review (e.g., on the computer system 312 at the expert site 302) the labeled images of the region of interest and the target blood vessel, which are generated using the image sensor in the remote venipuncture device 316, a portable image acquisition system (e.g., a portable ultrasound system / device), and a trained machine learning network. The labeled image(s) can be transmitted from the remote site 304 to the expert site 302 via a communication network. The expert 310 can review the labeled image to determine whether to continue drawing blood from the subject 306 based on the current position of the needle of the remote venipuncture device 316. If the expert 310 determines that it is acceptable to continue, the expert 310 can remotely enable the needle injection function of the remote venipuncture device 316 and instruct the subject 306 or the caregiver 308 to, for example, press a button on the remote venipuncture device 316 or the controller 318 to deploy (or actuate) the needle in the remote venipuncture device 316 and start drawing blood. When blood drawing is initiated, the remote venipuncture device 316 can deploy the needle to inject the needle into the target blood vessel and draw blood into a pre-loaded vial until the vial is filled to a predetermined amount. The remote venipuncture device 316 can then retract the needle to withdraw the needle from the subject. In some embodiments, the pre-loaded vial containing the subject's blood can be discharged or removed from the remote venipuncture device 316. The subject 306 or the caregiver 308 can then be instructed to remove the remote venipuncture device 316 from the subject's arm. Then, the expert 310 or a designee of the expert can provide instructions to the subject 306 or the caregiver 308 regarding the placement of a bandage, and the expert 310 (or the designee of the expert) can also monitor the subject 306 during a short observation period. Once the procedure is complete, the subject 306 or the caregiver 308 can place the blood sample(s) in the blood vial(s) in a sample return container (e.g., a pre-paid shipping container) to return the blood sample and the device to the blood analysis laboratory. The received blood sample can be analyzed, and the blood analysis laboratory can post the laboratory results to the subject's medical file. In some embodiments, the remote venipuncture device 316 and the portable ultrasound device can also be placed in the same or different containers and returned to the medical laboratory or other appropriate entity.

[0035] Figure 4A A top view of an example remote vascular access device according to an embodiment is shown, and Figure 4B An embodiment is shown in which Figure 4A The rear view and side view of the example remote vascular access device of. Figure 4A AndFigure 4B The exemplary remote vascular access device in is configured as a supervised remote phlebotomy device (SRPD). As described above, in some embodiments, the remote vascular access device can be configured for other applications, such as intravenous delivery of drugs and placement of IVs. In some embodiments, the remote phlebotomy device 402 can be configured as an "armband" or "cuff" 404 that can be positioned around a subject's arm (e.g., similar to a blood pressure cuff). As Figure 4A and Figure 4B shown, for blood drawing, the remote phlebotomy device 402 can be positioned around the subject's arm 406 between the shoulder and the wrist, proximal or distal to the elbow 412. For example, in some embodiments, the remote phlebotomy device 402 can be positioned around the lower arm 410 distal to the subject's elbow 412 or around the upper arm 408 proximal to the subject's elbow 412. In Figure 4A and Figure 4B , the remote phlebotomy device 402 is shown positioned around the lower arm 410 distal to the subject's elbow 412. In some embodiments, the remote phlebotomy device 402 can be coupled to a controller 434 (e.g., Figure 1 the controller 126 shown in ) via a connector 438 (e.g., a cable) and communicate with the controller 434. The remote phlebotomy device 402 and / or the controller 434 can communicate with a computing system 434 (e.g., Figure 1 the computing system 110 shown in ) at the location of the subject (i.e., the remote site) via a communication link 440 (e.g., a wired or wireless communication link).

[0036] In Figure 4A , a top view of the remote phlebotomy device 402 with the cuff 404 laid flat is shown. The cuff 404 can include an attachment mechanism 414, e.g., Velcro, at the ends of the cuff 404 to secure it when the cuff 404 is arranged around the subject's arm. In some embodiments, the remote phlebotomy device 402 can also include a device stabilization mechanism (not shown) to stabilize the device 402 on the subject's arm. For example, the cuff 404 can incorporate an inflatable portion or a tourniquet-like mechanism. In some embodiments, the remote phlebotomy device 402 can also be configured to constrict around the subject's arm to increase the diameter of the target blood vessel (e.g., a vein). For example, the remote phlebotomy device 402 can be configured to constrict around the subject's arm to increase the diameter of the target blood vessel distal to the remote phlebotomy device (e.g., the cuff 404) due to increased impedance of venous blood return.

[0037] The remote venipuncture device 404 may include an image sensor (e.g., the ultrasound transducer array 416), a blood sampling assembly 418, and an electrical and control interface 420. Although Figure 4A and Figure 4B the example remote venipuncture device 402 shown in includes an ultrasound transducer array, it should be understood that in some embodiments, other image sensors and imaging techniques may be used in the remote venipuncture device 402. The ultrasound transducer array 416 may be configured to connect to a portable ultrasound system (e.g., Figure 1 the image acquisition system 112 shown in) and communicate with the portable ultrasound system. The signals acquired by the ultrasound transducer array 416 may be provided to the ultrasound system to generate an image, for example. In some embodiments, as described above, an image analysis module (e.g., a machine learning network) may be implemented on the ultrasound system or other computer system coupled to the ultrasound system (e.g., Figure 1 the computer system 110 shown in), and the image analysis module is configured to perform image analysis on the acquired ultrasound images. In some embodiments, the image analysis module (e.g., a machine learning network) may be trained to analyze or interpret image data (or images) to determine, for example, the target blood vessel location and characteristics (e.g., blood vessel centroid depth, diameter, position along the ultrasound array, etc.). The segmentation of the target blood vessel may be based on machine learning of the morphological and spatial information in the images (e.g., ultrasound images) of the region of interest and the target blood vessel. In some embodiments, a neural network may be trained to learn features at multiple spatial and temporal scales. The blood vessel of interest may be distinguished based on the shape and / or appearance of the blood vessel wall, the shape and / or appearance of the surrounding tissue, etc. Characteristics such as blood vessel diameter may be used to determine whether the blood vessel is suitable for needle insertion. In some embodiments, the insertion point may also be determined based on the determined location of the target blood vessel (e.g., using the image analysis module), and the depth and path of the needle of the remote vascular access device 402 from the surface of the subject to the target blood vessel may be calculated. Additionally, in some embodiments, one or more of the acquired images may be analyzed (e.g., using the image analysis module) to detect critical structures that the needle should avoid, and the path from the surface of the subject (e.g., the skin) to the target blood vessel may be calculated such that the needle avoids the critical structures and intersects the target blood vessel. The location and characteristic information determined by the image analysis module (e.g., a machine learning network) may be provided to, for example, the robotic blood sampling assembly 418 (e.g., electrical control).

[0038] The electrical and control interface 420 may be configured to control the various operations of the blood sampling assembly 418. In some embodiments, the electrical and control interface 420 may be coupled to a controller 434 (e.g., Figure 1The controller 126) shown in . The blood sampling assembly 518 can include a needle 422, a pre-loaded (one or more) blood vial 424, a blood detection system 426, a needle injection system 428, and a needle positioning system that can include a needle angle control 430 and a needle translation track 432. In some embodiments, the needle 422 can be a standard 21 or standard 23 gauge needle for blood sampling. In some embodiments, one or more blood vials 424 can be provided in the blood sampling assembly 418. In some embodiments, the blood sampling assembly 418 can include up to four built-in blood vials 424. The blood sampling assembly 418 can be configured to include an automatic flow control to fill one or more vials 424. Thus, more than one vial 424 can be filled with blood, just as blood is typically collected in several vials in a medical venipuncture laboratory. The needle injection system 428 can be configured to actuate or deploy the needle 422 in response to an input received, for example, from the controller 434 (e.g., a subject or caregiver presses a button on the controller 434) or a command signal received by the electrical and control interface 420. In some embodiments, as described above, the command signal can be received from, for example, a computer system at an expert site or from an image analysis module at a remote site.

[0039] In some embodiments, the robotic blood sampling assembly 418 can be configured to allow adjustment of the positioning of the needle 422 within the remote vascular access device 402. In some embodiments, the needle angle control 430 can be configured to adjust the angle of the needle 422 relative to the surface of the subject. In some embodiments, the blood sampling assembly 418 can advantageously be configured to provide additional degrees of freedom for the needle 422, which can advantageously allow the needle 422 to automatically fine-tune its position relative to the target blood vessel and the appropriate insertion point. For example, in some embodiments, the needle translation track 432 can be configured to allow the translational position of the needle 422 to be automatically adjusted along the ultrasound array 416. The additional degrees of freedom can be used prior to needle insertion to slide the needle 422 along (e.g., along the needle translation track 432) the ultrasound array 416 (e.g., the long axis of the ultrasound transducer array 416) for a "fine positioning" step. This feature can be advantageous by enabling a user with limited dexterity (e.g., a subject or caregiver) to use the remote vascular access device 402. As a result, the user only needs to position the remote venipuncture device 402 such that the target blood vessel is within the field of view of the ultrasound transducer array 416 (e.g., within approximately 4 cm).

[0040] Figure 5It is a block diagram of an exemplary computer system according to an embodiment. The computer system 500 can be used to implement various systems and methods described herein. In some embodiments, the computer system 500 can be a workstation, a laptop computer, a tablet device, a mobile device, a multimedia device, a network server, a mainframe, one or more controllers, one or more microcontrollers, or any other general-purpose or special-purpose computing device. The computer system 500 can operate autonomously or semi-autonomously, or can read executable software instructions from a memory or storage device 516 or a computer-readable medium (such as a hard disk drive, a CD-ROM, a flash memory), or can receive instructions from a user via an input device 520 or any other source logically connected to the computer or device (such as another networked computer or server). Thus, in some embodiments, the computer system 500 may also include any suitable device for reading a computer-readable storage medium.

[0041] Data (such as data collected using an imaging system (e.g., an ultrasound imaging system, an optical imaging system, etc.)) can be provided to the computer system 500 from the data storage device 516 and received in the processing unit 502. In some embodiments, the processing unit 502 includes one or more processors. For example, the processing unit 502 can include one or more of a digital signal processor (DSP) 504, a microprocessor unit (MPU) 506, and a graphics processing unit (GPU) 508. The processing unit 502 also includes a data acquisition unit 510, which can be configured to electronically receive data to be processed. The DSP 504, MPU 506, GPU 508, and data acquisition unit 510 are all coupled to a communication bus 512. The communication bus 512 can be, for example, a set of wires or hardware for exchanging data between peripheral devices or between any components in the processing unit 502.

[0042] The processing unit 502 may also include a communication port 514 for electronic communication with other devices, which can include a storage device 516, a display 518, and one or more input devices 520. Examples of the input device 520 include, but are not limited to, a keyboard, a mouse, and a touch screen through which a user can provide input. The storage device 516 can be configured to store data, which can include data such as image data, segmentation data, labeled image data, whether the data is provided to the processing unit 502 or processed by the processing unit 502. The display 518 can be used to display images and other information, such as magnetic resonance images, patient health data, etc.

[0043] The processing unit 502 can communicate electronically with the network 522 to send and receive data and other information. The communication port 514 can be coupled to the processing unit 502 via a switched central resource (e.g., the communication bus 512). The processing unit can include a temporary memory 524 and a display controller 526. The temporary memory 524 can be configured to store temporary information. For example, the temporary memory 524 can be a random access memory.

[0044] Figure 6 is a schematic diagram of an exemplary ultrasound system according to an embodiment. Figure 6 An example of an ultrasound system 600 is shown. The ultrasound system 600 can be used to implement the systems and methods described in this disclosure. The ultrasound system 600 includes a transducer array 602, and the transducer array 602 includes a plurality of individually driven transducer elements 604. The transducer array 602 can include any suitable ultrasound transducer array, including linear arrays, curved arrays, phased arrays, and the like. Similarly, the transducer array 602 can include 1D transducers, 1.5D transducers, 1.75D transducers, 2D transducers, 3D transducers, and the like. As described above, in some embodiments, the transducer array 604 can be incorporated into a Figure 4A remote vascular access device as shown, and coupled and communicated with, for example, a portable ultrasound system, which can incorporate the remaining elements discussed below with respect to Figure 6 discussion.

[0045] When excited by the transmitter 606, a given transducer element 604 generates a train of ultrasonic energy. The ultrasonic energy (e.g., echoes) reflected back to the transducer array 602 from the object or subject under study can be converted into electrical signals (e.g., echo signals) by the respective transducer elements 604, and can be individually applied to the receiver 608 through a set of switches 610. The transmitter 606, the receiver 608, and the switches 610 operate under the control of a controller 612, which can include one or more processors. As an example, the controller 612 can include a computer system.

[0046] The transmitter 606 can be programmed to emit non-focused or focused ultrasonic waves. In some configurations, the transmitter 606 can also be programmed to emit divergent waves, spherical waves, cylindrical waves, plane waves, or a combination thereof. Additionally, the transmitter 606 can be programmed to transmit spatially or temporally encoded pulses.

[0047] In some configurations, the transmitter 606 and the receiver 608 can be programmed to achieve a high frame rate. For example, a frame rate associated with an acquisition pulse repetition frequency (“PRF”) of at least 100 Hz can be achieved. In some configurations, the ultrasound system 600 can sample and store at least one hundred sets of echo signals in the time direction.

[0048] Using techniques described in the present disclosure or otherwise known in the art, the controller 612 can be programmed to implement an imaging sequence. In some embodiments, the controller 612 receives user input that defines various factors used in the design of the imaging sequence.

[0049] Scanning can be performed by setting the switches 610 to their transmit positions, thereby causing the transmitters 606 to be instantaneously turned on to excite the transducer elements 604 during a single transmit event according to the implemented imaging sequence. The switches 610 can then be set to their receive positions, and the echo signals generated by the transducer elements 604 in response to one or more detected echoes can be measured and applied to the receiver 608. The individual echo signals from the transducer elements 604 can be combined in the receiver 608 to produce a single echo signal.

[0050] The echo signal is transmitted to a processing unit 614, which can be implemented by a hardware processor and memory, for processing the echo signal or an image generated from the echo signal. As an example, the processing unit 614 can use the methods described in the present disclosure to generate an image of a blood vessel of interest. The image generated by the processing unit 614 based on the echo signal can be displayed on a display system 616.

[0051] Computer-executable instructions for supervised remote intervention according to the above method can be stored in the form of a computer-readable medium. Computer-readable media include volatile and non-volatile, removable and non-removable media implemented by any method or technology for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other memory technologies, compact disc ROM (CD-ROM), digital versatile disc (DVD) or other optical memory, magnetic tape cartridges, tapes, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired instructions and can be accessed by a system (such as a computer), including access via the Internet or other computer networks.

[0052] The invention has been described in terms of one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, other than those clearly stated, are possible and within the scope of the invention.

Claims

1. A method for remote intervention for a subject, the method comprising: Acquiring an image of an area of interest of the subject using an interventional device and an image acquisition system located on the subject, the area of interest including a target structure, and the subject being located at a first site; Analyzing the acquired image using an image analysis module to identify and label the target structure in the area of interest; Transmitting the labeled image from the first site to a second site for expert review, wherein the second site is remote from the first site; And Receiving, at the first site, a command signal from the second site, the command signal being generated based on the expert review of the labeled image, and the command signal being configured to control the operation of the interventional device.

2. The method according to claim 1, wherein Analyzing the acquired image further includes: analyzing the acquired image to detect critical structures that the needle should avoid, and calculating a path from the surface of the subject such that the needle avoids the critical structures and intersects the target structure.

3. The method according to claim 1, further comprising causing deployment of a needle of the interventional device based on the command signal.

4. The method according to claim 1, further comprising enabling the interventional device for deployment based on the command signal.

5. The method according to claim 3, further comprising causing the deployment of the needle of the interventional device.

6. The method according to claim 1, characterized in that, The image analysis module is implemented as a machine learning network.

7. The method according to claim 1, wherein The interventional device is a vascular access device configured for blood drawing.

8. The method according to claim 1, characterized in that The interventional device is a vascular access device configured for intravenous drug delivery.

9. The method according to claim 1, wherein The interventional device includes an ultrasound transducer, and the image acquisition system is an ultrasound system.

10. The method according to claim 1, characterized in that, The interventional device includes an optical image sensor, and the image acquisition system is an optical imaging system.

11. The method according to claim 1, characterized in that, Transmitting the labeled image from the first site to the second site for expert review includes: transmitting the labeled image from the first site to the second site via a communication network.

12. The method according to claim 1, characterized in that, The interventional device is a remote vascular access device, the target structure is a target blood vessel, and using an image analysis module to analyze the acquired image to identify and label the target structure in the area of interest includes: determining one or more of the location of the target blood vessel, the centroid depth of the target blood vessel, and the diameter of the target blood vessel.

13. The method according to claim 12, further comprising determining whether the target blood vessel is suitable for needle insertion based on the determined diameter of the target blood vessel.

14. The method according to claim 1, characterized in that The interventional device is configured to be positioned around the subject's arm.

15. The method according to claim 1, characterized in that, The interventional device includes a cuff configured to be positioned around the subject's arm.

16. The method according to claim 1, characterized in that, The command signal is further generated based on user input received at the second site.

17. The method according to claim 1, further comprising monitoring the interventional device based on the image acquired using the interventional device and the image acquisition system to determine a change in position of the interventional device.

18. A system for remote intervention on a subject, the system comprising: An intervention device positioned on the subject, the intervention device comprising: An image sensor; A needle; and A robotic assembly, the robotic assembly comprising a needle positioning system configured to automatically adjust the position of the needle relative to the image sensor to align the needle with a target structure in the region of interest of the subject; and An image acquisition system coupled to the image sensor of the intervention device; and An image analysis module coupled to the intervention device and the image acquisition system, the image analysis module configured to analyze an image of the region of interest of the subject to identify and mark the target structure, wherein the image of the region of interest is acquired using the image sensor and the image acquisition system.

19. The system according to claim 18, wherein, The image analysis module is a machine learning network.

20. The system according to claim 18, wherein The needle positioning system is further configured to automatically adjust the position of the needle to align the needle with a target insertion point of the target structure and avoid critical structures.

21. The system according to claim 18, wherein The intervention device is a vascular access device, and the intervention device further comprises a cuff configured to be positioned around the arm of the subject.

22. The system according to claim 18, wherein The intervention device is a vascular access device configured for blood sampling, and the intervention device further comprises one or more vials.

23. The system according to claim 18, wherein The intervention device is a vascular access device configured for intravenous drug delivery.

24. The system according to claim 18, wherein The image sensor is a transducer array, and the image acquisition system is an ultrasound system.

25. The system according to claim 18, wherein The image sensor is an optical image sensor, and the image acquisition system is an optical imaging system.

26. The system according to claim 18, wherein The intervention device is a vascular access device, the target structure is a target blood vessel, and the image analysis module is further configured to determine one or more of the position of the target blood vessel, the centroid depth of the target blood vessel, and the diameter of the target blood vessel.

27. The system according to claim 18, wherein The intervention device is a vascular access device configured to be positioned around the arm of the subject and constrict around the arm of the subject to increase the diameter of the target blood vessel.

28. A method for remote intervention on a subject, the method comprising: Acquiring an image of a region of interest of the subject using an intervention device located on the subject and an image acquisition system, the region of interest including a target structure; Analyzing the acquired image using an image analysis module to identify and mark the target structure in the region of interest; And Generating a command signal using the image analysis module, the command signal being generated based on the marked image and configured to control the operation of the intervention device.

Images