Ultrasound imaging multi-array probe equipment and systems

Abstract

This invention provides an ultrasonic scanning device. [Solution] The ultrasound scanning device uses multiple transducer arrays and physical gaps for guiding and inserting medical instruments such as needles, as well as a method for detecting and visualizing the inserted medical instruments within a target area of ​​the patient's anatomical structure.

Description

Detailed Description of the Invention

[0001] (Cross - Reference to Related Applications) This application claims priority and the benefit of the filing date from the disclosure of the following U.S. Patent Application No. 63 / 452,920, filed on March 17, 2023. The entire disclosure of that application is incorporated herein by reference.

[0002] [[ID=10]](Statement Regarding Federally Sponsored Research in the United States) This invention was made with government support under Grant No. R44NS120798 awarded by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS) of the United States. The government has certain rights in this invention.

Technical Field

[0003] The present invention relates to an ultrasonic scanning device, and particularly to a device and method for assisting a needle injection procedure using ultrasonic scanning.

Background Art

[0004] Interventional surgery in medicine encompasses a wide range of procedures, including lumbar puncture, bone marrow biopsy, and injections for acute and chronic pain relief. Available interventional guidance techniques range from palpation-based methods without image guidance to guidance using ultrasound imaging, computed tomography, or fluoroscopy. Palpation methods are low-cost and can be performed at the bedside, but they suffer from low surgical success rates and high complication rates. Conventional ultrasound can improve success rates and is used in some cases, but it requires manipulating the ultrasound probe while simultaneously inserting medical instruments (e.g., needles), which usually necessitates the use of both hands, resulting in limitations including a long learning curve and workflow constraints. X-ray-based methods (e.g., computed tomography or fluoroscopy) have relatively high success rates, but they expose patients to ionizing radiation, increase surgical costs, and are typically not bedside procedures or are incompatible with workflow constraints in areas such as emergency medicine.

[0005] This invention describes a unique ultrasonic device for two-dimensional and three-dimensional scanning to overcome the limitations of interventional surgical guidance methods in the current state of the art, particularly in medical needle-guided surgery, wherein there is a physical separation between arrays of the device, which may function as or include a guide member used for a medical instrument (e.g., a needle). In this specification, the device can achieve in-plane propulsion of a needle by acquiring ultrasonic images in real time and / or simultaneously from multiple ultrasonic transducer arrays. This invention retains the advantages of medical ultrasound while solving common workflow obstacles that reduce its utilization.

[0006] Related technologies include devices that facilitate interventional surgery related to medical instruments.

[0007] PCT application No. PCT / JP2014 / 050941 (incorporated herein by reference) describes a system comprising an ultrasound probe and a puncture needle, wherein the ultrasound probe has a wedge arrangement, thereby providing an ultrasound probe configured to tilt a single ultrasound transducer array housed within the probe at a certain angle to the body, so as to be angled to the patient's anatomical structure. In relation to the present invention as described herein, the system of PCT / JP2014 / 050941 does not support two or more arrays and does not allow a midline needle trajectory in a plane. The present invention also includes components arranged to reduce acoustic reverberation caused by the angled transducer array within the probe housing.

[0008] PCT application No. PCT / CA2009 / 001700 (incorporated herein by reference) describes an ultrasonic imaging and medical instrument guiding apparatus comprising two ultrasonic probes and a positionable medical instrument guiding member, wherein the two ultrasonic probes are positioned on a bracket to acquire three-dimensional images of different overlapping volumes, and the positionable medical instrument guiding member allows the medical instrument to be transmitted from the two ultrasonic probes into the overlapping region of the imaging volumes. However, the arrangement of PCT / CA2009 / 001700 differs from the present invention as described herein, in the embodiments of the present invention as described herein, the apparatus comprises two or more angled ultrasonic transducer arrays, wherein in the embodiments, each array has an acoustic spacing that allows the ultrasonic transducer arrays to be positioned at an angle, and among other reasons, this also differs from PCT / CA2009 / 001700.

[0009] U.S. Patent Application No. 06 / 396,784 (incorporated herein by reference) describes an ultrasonic probe for needle insertion procedures, comprising a support member and a groove within the support member, the support member having an array of ultrasonic transducer elements laid flat at its front end, and the groove being used to guide a needle. In the ultrasonic probe of U.S. Patent Application No. 06 / 396,784, the groove forms an opening at the front end of the support member, and one or more transducer elements are located near the opening of the groove and between other transducer elements, so that no empty space is left at the front end of the support member. In contrast to the ultrasonic probe of U.S. Patent Application No. 06 / 396,784, among other reasons, the present invention comprises two or more angled ultrasonic transducer arrays, each array having an acoustic spacing that allows the ultrasonic transducer arrays to be arranged at an angle. The present invention as described herein also comprises ultrasonic transducer arrays that generate overlapping two-dimensional images. Finally, the present invention includes, for example, an arrangement that allows the needle to be at an angle of up to 20 degrees with respect to the central axis of the needle guide member, and is an improvement over U.S. Patent Application 06 / 396,784 and other related technologies.

[0010] JP7153980A (incorporated herein by reference) describes an ultrasonic probe comprising two flattened ultrasonic transducer arrays, having a groove between the two flattened ultrasonic transducer arrays, and also requiring a cannula (needle) positioned parallel to the principal axis of the groove. In contrast to the ultrasonic probe of JP7153980A, the present invention described herein comprises two or more angled ultrasonic transducer arrays, wherein, in embodiments, each array has an acoustic spacing that allows the ultrasonic transducer arrays to be positioned at an angle. The present invention also includes ultrasonic transducer arrays that generate overlapping two-dimensional images. Finally, the present invention includes, for example, an arrangement that allows the needle to be angled up to 20 degrees with respect to the central axis of a needle guide member, and is generally an improvement over JP7153980A and other related technologies.

[0011] U.S. Patent Application No. 06 / 511,285 (incorporated herein by reference) describes an ultrasonic transducer probe comprising a flattened ultrasonic transducer array having a gap that can receive a removable wedge-shaped cannula (needle) adapter. In contrast to the ultrasonic probe of U.S. Patent Application No. 06 / 511,285, the present invention described herein comprises two or more angled ultrasonic transducer arrays, wherein, in embodiments, each array has an acoustic spacing that allows the ultrasonic transducer arrays to be positioned at an angle. The present invention also includes ultrasonic transducer arrays that generate overlapping two-dimensional images. Finally, the present invention includes, for example, an arrangement that allows a needle to be angled up to 20 degrees with respect to the central axis of a needle guide member, and is overall an improvement over U.S. Patent Application No. 06 / 511,285 and other related technologies.

[0012] U.S. Patent Application No. 06 / 014,076 (incorporated herein by reference) describes an ultrasonic transducer probe comprising a surface-proximal ultrasonic transducer element located on the surface of a subject's body, further comprising a molded cavity that provides a guide block to a cannula (needle) and allows the ultrasonic transducer probe to be removed from the inserted cannula, the guide block being disinfectable after removal. Distinguishing from the ultrasonic probe of U.S. Patent Application No. 06 / 014,076, the present invention comprises two or more angled ultrasonic transducer arrays, each array having an acoustic spacing that allows the ultrasonic transducer arrays to be positioned at an angle. The present invention also comprises ultrasonic transducer arrays that generate overlapping two-dimensional images. Finally, the present invention includes, for example, an arrangement that allows the needle to be angled up to 20 degrees with respect to the central axis of a needle guide member, and is overall an improvement over U.S. Patent Application No. 06 / 014,076 and other related technologies.

[0013] GB0307311A (incorporated herein by reference) describes an ultrasonic probe comprising a housing and a guide member for inserting a needle, the guide member including a channel located between ultrasonic transducers within the housing. In contrast to the ultrasonic probe of GB0307311A, the present invention described herein includes two or more angled ultrasonic transducer arrays, each array having an acoustic spacing that allows the ultrasonic transducer arrays to be positioned at an angle. The invention also describes an arrangement that allows the needle to be angled up to 20 degrees with respect to the central axis of the needle guide member. Finally, the invention specifies, as an example, components arranged to reduce acoustic reverberation resulting from angled transducer arrays within the probe housing, and is generally an improvement over GB0307311A and other related technologies.

[0014] PCT application No. PCT / US2018 / 026413 (incorporated herein by reference) describes a system comprising an ultrasonic probe, the ultrasonic probe comprising two ultrasonic transducers arranged at a certain angle, and a removable needle guide member provided between the two transducers, the two ultrasonic transducers transmitting sound waves to generate overlapping imaging regions, and the removable needle guide member extending toward a target position in the overlapping imaging regions. In difference from the ultrasonic probe of PCT / US2018 / 026413, the present invention described herein comprises two or more angled ultrasonic transducer arrays, each array having an acoustic spacing that allows the ultrasonic transducer arrays to be arranged at an angle. The present invention also describes an arrangement that allows the needle guide member to be integrated with the probe housing, thereby allowing the needle to be angled up to 20 degrees with respect to the central axis of the needle guide member. Finally, the present invention specifies, as an example, a component arranged to reduce acoustic reverberation caused by an angled transducer array within a probe housing, and is an overall improvement over PCT / US2018 / 026413 and other related technologies. [Overview of the project]

[0015] The exemplary embodiments described herein possess novel features, none of which are essential, and none assume all responsibility for their ideal attributes. The following description and drawings specifically illustrate some descriptive embodiments of the present disclosure and show several exemplary forms that can realize various principles of the present disclosure. However, these descriptive examples do not encompass the many possible embodiments of the present disclosure. Some advantageous features are summarized without limiting the scope of the claims. Referring to the drawings, other purposes, advantages and novel features of the present disclosure are described in the following detailed description of the present disclosure, and the drawings are intended to illustrate, not limit, the invention.

[0016] In the embodiments, the present invention overcomes the limitations of conventional interventional surgical guide systems by providing a form factor having multiple arrays, which allows a probe to be inserted into a medical instrument (e.g., a needle) with a centrally oriented trajectory. The unique form factor allows for real-time ultrasound acquisition via a midline approach and is typically preferred for use in neuroaxial needle-guided surgeries such as lumbar puncture or epidural anesthesia.

[0017] In the embodiment, the dual array probe may function as or include a needle guide member that guides the trajectory of a medical instrument to pass through or approach the probe, and enables a midline, paramedian, or oblique needle approach.

[0018] In the embodiments, the present invention includes one or more mechanical devices used with a multi-array probe, which provide a removable component for holding a medical instrument or needle, and which has a locking function to clamp the needle and enable midline, paramedian, or oblique needle approaches.

[0019] In the embodiments, the present invention can realize multi-angle, multi-array composite and filtering, which can be used to improve the visualization of ultrasound imaging of bone anatomical structures, vascular anatomical structures, and inserted medical instruments (e.g., needles).

[0020] In the embodiment, the present invention includes a sensor in the probe to achieve ultrasonic data acquisition and volume reconstruction for alignment.

[0021] The drawings illustrate some aspects of some embodiments of the present invention and should not be used to limit or restrict the present invention. The drawings are used in conjunction with the description herein to explain some principles of the present invention. To more fully understand the essence and advantages of the technology, the drawings are combined with the following detailed description of the preferred embodiments.

Brief Description of the Drawings

[0022] [Figure 1] FIG. 1 is a schematic diagram of an exemplary ultrasonic system according to an embodiment of the present invention described herein, and a multi-array ultrasonic probe is incorporated in the exemplary ultrasonic system. [Figure 2] FIG. 2 is a schematic diagram of an exemplary multi-array ultrasonic probe according to an embodiment of the present invention described herein. [Figure 3A] FIG. 3A is a schematic diagram of an exemplary multi-array ultrasonic probe according to an embodiment of the present invention described herein, and a device fixed to the multi-array ultrasonic probe to provide a needle holding function. [Figure 3B] FIG. 3B is a schematic diagram of an exemplary multi-array ultrasonic probe according to an embodiment of the present invention described herein, and a device fixed to the multi-array ultrasonic probe to provide a needle holding function. [Figure 3C] FIG. 3C is a schematic diagram of an exemplary multi-array ultrasonic probe according to an embodiment of the present invention described herein, and a device fixed to the multi-array ultrasonic probe to provide a needle holding function. [Figure 3D] FIG. 3D is a schematic diagram of an exemplary multi-array ultrasonic probe according to an embodiment of the present invention described herein, and a device fixed to the multi-array ultrasonic probe to provide a needle holding function. [Figure 4A] FIG. 4A shows an exemplary ultrasonic scanning geometry realized by a multi-array ultrasonic probe according to an embodiment of the present invention described herein, and an exemplary illustration of a multi-angle collection and image compounding process for realizing visualization of a needle and bone. [Figure 4B]FIG. 4B shows an exemplary ultrasonic scanning geometry realized by a multi-array ultrasonic probe according to an embodiment of the present invention described herein, and an exemplary illustration of a multi-angle collection and image composite process for realizing visualization of a needle and a bone. [Figure 4C] FIG. 4C shows an exemplary ultrasonic scanning geometry realized by a multi-array ultrasonic probe according to an embodiment of the present invention described herein, and an exemplary illustration of a multi-angle collection and image composite process for realizing visualization of a needle and a bone. [Figure 5A] FIG. 5A shows an exemplary method used to simultaneously collect ultrasonic image data and position tracking data to support volume reconstruction according to an embodiment of the present invention described herein. [Figure 5B] FIG. 5B shows an exemplary method used to simultaneously collect ultrasonic image data and position tracking data to support volume reconstruction according to an embodiment of the present invention described herein. [Figure 5C] FIG. 5C shows an exemplary method used to simultaneously collect ultrasonic image data and position tracking data to support volume reconstruction according to an embodiment of the present invention described herein. [Figure 6] FIG. 6 shows a flowchart of an exemplary method for multi-angle composite for needle detection and enhancement according to an embodiment of the present invention described herein. [Figure 7] FIG. 7 shows a flowchart of an exemplary method for distinguishing a needle and a bone during a multi-angle composite and image rendering period according to an embodiment of the present invention described herein. [Figure 8A] FIG. 8A shows a flowchart of a process according to an embodiment of the present invention described herein, in which the device having an exemplary dual-array ultrasonic probe (with or without position tracking) can be used by a clinician to assist in an interventional procedure. [Figure 8B]Figure 8B shows a flowchart of a process according to an embodiment of the present invention described herein, in which the instrument having an exemplary dual-array ultrasound probe (with or without position tracking) can be used by a clinician to assist in interventional surgery. [Figure 9A] Figure 9A shows a schematic diagram and exploded view of an exemplary multi-array ultrasound probe according to an embodiment of the present invention described herein, the exemplary multi-array ultrasound probe being isolated from the patient's anatomical structure by an intervening acoustically transparent layer. [Figure 9B] Figure 9B shows a schematic diagram and exploded view of an exemplary multi-array ultrasound probe according to an embodiment of the present invention described herein, the exemplary multi-array ultrasound probe being isolated from the patient's anatomical structure by an intervening acoustically transparent layer. [Figure 10] Figure 10 shows a schematic diagram of an exemplary multi-array ultrasound probe according to an embodiment of the present invention described herein, the exemplary multi-array ultrasound probe being isolated from the patient's anatomical structure by an intervening acoustically transparent layer, and its clamping section, button placement and housing design being arranged to provide an unobstructed view of the medical device. [Figure 11] Figure 11 shows a schematic diagram of the acoustic field of view for an exemplary multi-array ultrasound probe and its needle. [Modes for carrying out the invention]

[0023] Ultrasound imaging transducer assemblies (also called ultrasound transducer arrays) are used in a variety of medical or clinical applications to realize medical imaging functions. In these non-limiting examples, ultrasound transducers are installed within a transducer array to transmit pulses, tones, sequences, or programmed energy signals to a target location of the object to be imaged. One specific example is one or more ultrasound transducer elements that transmit ultrasound signals into the patient's body and detect return signals, thereby forming a computer-generated image of the target area. Different ultrasound imaging modes can be employed according to certain applications and designs known to those skilled in the art. The present invention can be used in medical ultrasound applications, but is not limited thereto. As can be understood, and as will be obvious to those skilled in the art, various types of transducers, signal transmitters and / or receivers and other arrays can also benefit from the present invention. A preferred embodiment described herein describes a needle guide. As will be understood to those skilled in the art, the present invention can be used to guide various medical devices, including, but not limited to, catheters, trocars, ablation devices, cutting devices, or therapeutic applicators. In preferred embodiments, the present invention can be used in conjunction with the system and method previously disclosed by Mauldin et al. (PCT / US2019 / 012622) (incorporated herein by reference) for automated three-dimensional detection, guiding, and visualization of ultrasound-based therapeutic-guided surgery.

[0024] In embodiments of the present invention for the medical application of needle guides described herein, probes comprising two or more ultrasound transducer arrays (also called multi-array probes) are described. The goal of the multi-array ultrasound probe is to provide a passage for a medical instrument (e.g., a needle) so that it passes through the center of the probe contour on the patient's body at an incident angle substantially perpendicular to the patient's skin. In embodiments of the present invention, the medical instrument trajectory may be described as “in-plane,” of which the insertion point traverses the long axis of the probe housing; or as “midline,” of which the insertion trajectory is aligned with the axis of symmetry of the spinal vertebral bodies; or as “paramedian,” of which the insertion trajectory is performed at a constant angle with respect to the axis of symmetry of the spinal vertebral bodies. In embodiments, additional goals include improving the algorithmic contrast of the needle in the ultrasound image, distinguishing between bright anatomical structures (i.e., bones) and the needle in the ultrasound image, and three-dimensional ultrasound scanning, thereby facilitating the evaluation of the anatomical structures of most patients. In the examples, for example, images acquired from each ultrasonic transducer array in a multi-array probe may be composited by a simple average, weighted average, or similarity-based measurement, thereby forming a composite image that has a relatively wide field of view and includes overlapping image regions.

[0025] In one exemplary embodiment shown in Figure 1, a multi-array ultrasound probe 100 is connected to a mobile cart 102 via an electrical signal cable 101, allowing the imaging device to move toward the bed and be positioned in a desired direction to acquire images of the patient's anatomical structure. The cart 102 includes an enclosure 103, which may include a computer processor and monitor 104, a battery 105, and other relevant electronic devices, well known to those skilled in the art, necessary for powering the imaging device 100 and communicating with the imaging device 100. The cart 102 may also include additional input / output devices, such as a keyboard, mouse, or monitor 104, the monitor 104 of which may be a touchscreen display. The cart may also include a workbench 106 and a compartment 107, which facilitate the placement or storage of materials commonly used during interventional surgery (e.g., consumables, needles, ultrasound gel, and disinfectant wipes). The monitor 104 may be positioned relative to the cart, thereby facilitating the orientation of the imaging apparatus 100 and the monitor 104 to various relative positions, heights, and directions for needle-guided surgery. In a preferred embodiment, the enclosure 103 may simultaneously include the monitor 104, a computer processor, and an ultrasonic front-end electronic device. The computer processor within the enclosure 103 may be used to perform ultrasonic signal and image processing steps necessary to form a reconstruction of an ultrasonic image displayable on the monitor 104. Such processing steps are known to those skilled in the field of medical ultrasound and may include beamforming, bandpass filtering, scan conversion, spatial compounding, Doppler imaging, and image rendering. Two-dimensional and three-dimensional images may be rendered using various techniques, including, for example, simultaneous display as described in U.S. Patent No. 11,504,095 by Mauldin et al. (incorporated herein by reference).In a preferred embodiment, a computer processor within the enclosure 103 receives a signal from the ultrasound probe 100 indicating the probe's position on the patient's body, which is used to interpret the spatial position of the acquired real-time image data. In a preferred embodiment, the spatial alignment of the imaging data is used to reconstruct and render a three-dimensional ultrasound image on the monitor 104, which is functionally equivalent to fluoroscopic imaging of the anatomical structure of the skeleton.

[0026] In one exemplary embodiment, Figure 2 shows a multi-array ultrasound probe 100. The multi-array probe 100 has a housing component, which provides a handle portion 200 having a gripping feature 201 for holding the probe. Two ultrasound arrays 202 are coupled to the multi-array probe 100, which are connected to an ultrasound data acquisition electronic device via an integrated circuit and an electrical signal cable 101 interface to acquire ultrasound image datasets. The ultrasound arrays 202 of the multi-array probe are separated by a medical instrument guide member 203, which includes a gap integrated with the probe housing, and the gap provides a passage for a central needle trajectory 204 passing between the two ultrasound arrays 202. In this imaging arrangement, the fields of view (FOV) 205 of the two ultrasound arrays 202 overlap along the needle trajectory 204, thereby providing independent views of the needle from two different advantageous points. In some embodiments, the medical instrument guide member 203 provides an alignment method that ensures the central needle trajectory 204 and the fields of view (FOV) 205 of the two ultrasound arrays are coplanar, while minimizing the force applied to the instrument, which is advantageous for clinical procedures where the clinician relies on tactile feedback passing through the anatomical structure of the instrument (e.g., used to detect resistance loss). In some embodiments, the medical instrument guide member 203 allows the needle to be at an angle of up to 20 degrees with respect to the central axis of the medical instrument guide member 203. The dual array probe 100 is provided with a button 206 to provide control to the imaging function. The handle portion 200 includes a printed circuit board which provides a microprocessor interfaced to the button 206, provides a motion sensor integrated circuit, and can communicate digitally serially with the host processor of the ultrasound imaging system via the probe cable 101.

[0027] In one exemplary embodiment shown in Figure 3A, the multi-array probe 100 can be adapted to a sterile workflow, where the dual-array probe 100 is covered by a sterile sheath. The multi-array probe 100 is applied to a sterilized portion of a patient's anatomical structure 301 to support sterile imaging interrogation and, in this embodiment, demonstrates the insertion of a midline needle. A sterile needle holder 300 is temporarily fixed to the multi-array probe 100 and guides the central needle trajectory 204 within the instrument, facilitating the insertion of a midline needle in a plane into the target anatomical structure 304, where, in this example, the target anatomical structure 304 is the epidural space of the spine. Non-sterile patient anatomical structures may be covered by a sterile drape 302 (e.g., a surgical drape), while the sterilized portion of the patient's anatomical structure 301 is not covered. The needle holding component 300 is to which the attachment feature 305 is attached, and the attachment feature 305 is held between the housing and handle portion 200 of the dual array probe 100, thereby restricting the motion of the sterile sheath.

[0028] In a non-limiting embodiment shown in Figure 3B, a quick-release feature 303 is attached to the sterile needle retaining component 300, which enables the release of the midline needle 204 and simultaneously allows the probe to move away from the needle insertion position while the needle 204 remains positioned at the target anatomical structure 304. The quick-release feature 303 may be a removable component or may be integrated with the sterile needle retaining component 300, and may provide a needle release mechanism, such as sliding, rotating, unsnapping, or other methods well known to those skilled in the art.

[0029] In a non-limiting embodiment shown in Figure 3C, the multi-array probe 100 can be adapted to an aseptic procedure flow for paramedian needle insertion, where the dual-array probe 100 is covered with a sterile sheath and the sterile needle holder 300 is temporarily fixed to the multi-array probe 100. The multi-array probe 100 is applied to a sterilized portion of the patient's anatomical structure 301 to support sterile imaging and paramedian needle insertion. Non-sterile patient anatomical structures may be covered with a sterile drape 302 (e.g., a surgical drape), while the sterilized portion of the patient's anatomical structure 301 is not covered. The needle retaining component 300 has a lateral quick-release feature 305 attached to the short axis of the probe, which guides the paramedian needle trajectory 306 toward the side of the device and facilitates the insertion of the paramedian needle in a plane into the target anatomical structure 307, in this example the target anatomical structure 307 being the epidural space of the spine.

[0030] In a non-limiting embodiment shown in Figure 3D, a lateral quick-release feature 305 is attached to the sterile needle retaining component 300, which enables the release of the paramedian needle 306 and simultaneously allows the probe to move away from the needle insertion position while the needle 306 remains positioned at the target anatomical structure 307. The lateral quick-release feature 305 may be a removable component or may be integrated with the sterile needle retaining component 300, and may provide a needle release mechanism, such as a slide, rotation, snap release or other method well known to those skilled in the art.

[0031] Figures 4A to 4C show schematic diagrams of the scanning field of view 205 of the multi-array probe 100 when multi-angle beam steering is applied. In Figure 4A, the field of view 205 of the ultrasonic array 202 is forward-facing and has a neutral (0-degree) steering angle 400. In Figure 4B, the field of view 205 is tilted toward the central axis of the probe and has an inward (+θ) steering angle 401, increasing the overlap of the field of view 205 in the area 402 where the needle is placed. In Figure 4C, the field of view 205 is tilted away from the central axis of the probe and has an outward (-θ) steering angle 403, minimizing the overlap of the field of view 205 in the area 402 where the needle is placed. In this exemplary embodiment, the beam manipulation of each individual array can be controlled independently. The main processor of the ultrasonic imaging system can render two-dimensional images of each individual acquisition result, or perform geometric composites on the acquisition results to combine information in the overlapping area of ​​the field of view 205, a method referred to by those skilled in the art as spatial composite.

[0032] In the non-limiting embodiment shown in Figure 5A, a clinician can adjust the position of the multi-array ultrasound probe 100 during the scanning period to collect a series of motion-tracking ultrasound images, where a motion sensor integrated circuit records motion information for each two-dimensional ultrasound image and digitizes it using a microprocessor in the multi-array probe 100, transmitting it to the host processor of the ultrasound system. In this exemplary embodiment, the multi-array probe 100 sweeps around an axis 500 to generate a three-dimensional dataset 501 using the recorded motion data from each two-dimensional ultrasound image 502. The multi-array probe 100 can translate or rotate around an alternative axis to collect three-dimensional datasets of various shapes, which may be advantageous for certain image-guided surgeries, for example, translating the multi-array probe 100 along a linear path along the spine for nerve axis needle-guided surgery.

[0033] The host processor of the ultrasound system can project a two-dimensional image 502 into a three-dimensional rendering space according to the exemplary flowchart shown in Figure 5B by rendering a geometrically accurate volumetric rendering using motion tracking information. First, in block 503, the user positions the multi-array ultrasound probe 100 on the patient's anatomical structure 301 in the patient's body. Next, in block 504, the user selects a 3D imaging mode and starts the three-dimensional image acquisition process using either the button 206 on the probe 100, the user interface on the monitor 104, or another user input method. In block 505, the two-dimensional ultrasound image 502 is acquired by an electronic device, paired with the spatial positioning of the probe 100 for the image acquisition period determined by the motion sensor integrated circuit, and stored in the system memory on the processor. The system selectively waits for a certain period of time (e.g., a certain short period) in block 506, and then in block 507, evaluates whether the user has stopped three-dimensional acquisition or whether the system has reached a predetermined time limit. If the three-dimensional image acquisition process is not stopped, another two-dimensional ultrasound image 502 is acquired in block 505. If the three-dimensional image acquisition process is stopped, the system projects the spatially referenced two-dimensional ultrasound image 502 onto a geometrically accurate rendering of the three-dimensional volume 501 in block 508. The rendering process may include smoothing, filtering, or other methods well known to those skilled in the art. Next, in block 509, the system performs post-processing on the two-dimensional ultrasound image 502 or the three-dimensional dataset 501 to achieve specific reconstructions of selected anatomical structures, such as blood flow (separating areas with blood flow by Doppler imaging), bone-only rendering (e.g., as described in U.S. Patent No. 10,548,564 by Mauldin et al., incorporated herein by reference) and similar methods. Finally, in block 510, the system renders the processed three-dimensional dataset and displays it on monitor 104.As shown in Figure 5B, the three-dimensional image acquisition process may be initiated before needle insertion (scout scan), during the needle insertion period to assist needle guidance, or after the needle has reached the target anatomical structure to verify whether the needle position matches the clinician's expectations (e.g., that the needle is positioned in the precise spinal segment for steroid injection). Three-dimensional rendering and display on monitor 104 may be performed partially or fully concurrently with the three-dimensional image acquisition process, interchangeably, to efficiently display and update the three-dimensional rendering in real time.

[0034] In a preferred embodiment, Figure 5C shows a volume rendering 511 of the bone only of the target anatomical structure 512. In this non-limiting example, the target anatomical structure 512 of the periphery nerve block is a valley in the fascial plane between the psoas muscle and the superior pubic ramus. In this non-limiting example, a bone segmentation filter is applied to extract the bone surface from a two-dimensional ultrasound image 502, and only the bone surface is projected into the volume rendering space. In this example, a pseudo-fluoroscopic volume rendering 513 is superimposed with a volume rendering 511 of the femoral head and ilium.

[0035] Figure 6 shows an illustrative flowchart of the multi-array, multi-angle needle filtering method. In block 600, the user positions the multi-array ultrasound probe 100 over the patient's anatomical structure 301 on the patient's body and inserts the needle. Next, in block 601, the system uses two ultrasound arrays 202 to acquire images at one or more beam steering angles, which are neutral 400, inward 401, or outward 403. In block 602, the system applies a needle detection filter independently to each image. In block 603, the system applies a spatial composite of background ultrasound data and the region containing the needle to generate a single image. Finally, in block 604, the combined image is rendered and displayed on monitor 104.

[0036] Figure 7 shows an exemplary flowchart illustrating a multi-array, multi-angle needle and bone filtering method. This method provides signal separation to distinguish bright needle structures from bright bone surface features in ultrasound imaging data. First, in block 700, the user positions the multi-array ultrasound probe 100 over the patient's anatomical structure 301 on the patient's body and inserts the needle. In block 701, the user acquires a first set of images using the method described in Figure 6. The system waits for a certain period of time (e.g., less than 200 milliseconds) in block 702, and then acquires a second set of images using the method described in Figure 6 in block 703. Next, in block 704, the system calculates motion estimation in the ultrasound images between image set #1 and image set #2. In block 705, the system isolates fast-moving regions in the ultrasound images based on the motion estimation. Then, in block 706, the system applies a needle filter to the fast-moving regions in the ultrasound images of image set #2. Then, in block 707, the system extracts the needle regions from the fast-moving regions to form an image of only the needles. Simultaneously, in block 708, the system performs spatial composite on the ultrasound images in image set #2 and generates a single composite ultrasound image. Next, in block 709, the system combines the needle-only image from block 707 with the composite ultrasound image from block 708. Finally, in block 710, the combined image is rendered and displayed on monitor 104.

[0037] Figure 8A shows an exemplary flowchart illustrating the process by which a clinician performs a needle retention procedure using the present invention. First, in block 800, the user applies the sterile needle holder 300 to the multi-array ultrasound probe 100. Next, in block 801, the user positions the multi-array probe 100 on the patient's body and positions the needle by acquiring ultrasound images to recognize the target patient's anatomical structure 304. Once the user has recognized the target patient's anatomical structure 304, in block 802, the user pushes the needle 204 in using the medical instrument guide member 203. The quick-release feature 303 of the needle holder 300 ensures that the needle is held within the desired trajectory and plane of the ultrasound array. In block 803, the user observes the position of the needle 204 using the real-time ultrasound image display on the monitor 104. In block 804, the user determines whether the needle 204 has reached the target patient's anatomical structure 304. If the needle 204 has not reached the target patient's anatomical structure 304, the user returns to block 802 and continues to adjust the position of the needle 204. Finally, if the needle 204 successfully reaches the target patient's anatomical structure 304, in block 805, the clinician continues the medical procedure according to the care standards.

[0038] Figure 8B shows an exemplary flowchart illustrating the process by which a clinician performs a needle insertion procedure using the 3D scout scanning method of the present invention. First, in block 800, the user applies the sterile needle holder 300 to the multi-array ultrasound probe 100. Next, in block 806, the user positions the multi-array probe 100 on the patient's body and sweeps the probe 100 at a constant angle to obtain the scout scan result of a three-dimensional dataset of the patient's anatomical structure. In block 807, as described in Figure 5B, the system creates a volume rendering 511 of the patient's anatomical structure, recognizes the target location for needle insertion, and displays the spatial information on the monitor 104. Recognizing the target location for needle insertion may, alternatively, be performed by the clinician using the volume rendering 511. In block 808, the clinician evaluates whether the current needle insertion target meets expectations based on the needs of the medical procedure. If the current needle insertion target is incorrect, in block 809 the clinician adjusts the position of probe 100 in the patient's body based on the interpretation of the current target and the expected needle insertion position in volume rendering 511, and then returns to block 806. Finally, if the current needle insertion target meets the user's expectations, in block 810 the clinician continues the needle insertion process as described in blocks 802 to 805 of Figure 8A.

[0039] In one exemplary embodiment, Figures 9A–9B show a multi-array ultrasound probe. The multi-array probe has a housing component 900, which includes two ultrasound arrays 202, and the two ultrasound arrays 202 are connected to an ultrasound data acquisition electronic device via an integrated circuit and an electrical signal cable 101 interface to acquire ultrasound image data sets. The ultrasound arrays 202 of the multi-array probe are separated by a medical instrument guide member 203, which includes a gap integrated with the probe housing 900, and the gap provides a passage for a central needle trajectory passing between the two ultrasound arrays 202. The multi-array ultrasound probe is arranged so that the two ultrasound arrays 202 do not directly contact the patient's anatomical structures and rotate within the probe housing 900, thereby providing a lower angle of incidence to the medical instrument guide member 203 compared to the embodiment in Figure 2. While more or fewer intervening acoustic permeable layers may be preferred, the two ultrasonic transducer arrays 202 are acoustically coupled to the patient's anatomical structure via three intervening acoustic permeable layers 902, 904, and 906. In this embodiment, the outermost acoustic permeable layer 902 contacts the patient's anatomical structure or probe sheath and is composed of a rigid, semi-rigid, or substantially rigid material (e.g., plastic or elastomer). In this embodiment, the central acoustic permeable layer 904 provides an acoustic "filler" between the outermost permeable layer 902 and the innermost permeable layer 906 and may be composed of a rigid, semi-rigid, or substantially rigid material (e.g., plastic or elastomer), a deformable, semi-deformable, or substantially deformable material (e.g., elastomer or gel), or a fluid. In this embodiment, the innermost acoustically transparent layer 906 provides a coating to protect the ultrasonic transducer array and may be composed of a rigid, semi-rigid or substantially rigid material (e.g., plastic or elastomer), a deformable, semi-deformable or substantially deformable material (e.g., elastomer).The acoustically transparent layers 902, 904, and 906 may be composed of a material that has low acoustic attenuation and an acoustic impedance that matches the ultrasonic transducer array and / or the patient, thereby maximizing acoustic energy transmission and minimizing acoustic reverberation. The material composition and manufacturing method of the acoustically transparent layers 902, 904, and 906 can provide more advantages than the embodiment in Figure 2, such as better adaptability to the patient's anatomical structure, the ability to sterilize or disinfect the ultrasonic probe at a high level, and better durability. Figure 9B shows an exploded view of the multi-array ultrasonic probe of this embodiment. The multi-array probe has a button 910 coupled to the probe housing to provide control over imaging functions, and a clamping feature 908 coupled to hold the probe. A printed circuit board 911 is coupled to the probe housing 900, which provides a microprocessor interfaced to the button 910, provides a motion sensor integrated circuit, and can perform digital serial communication with the host processor of the ultrasonic imaging system via the probe cable 101.

[0040] Figure 10 shows a schematic diagram of how the multi-array ultrasound probe in Figures 9A-9B appears to the user during an interventional procedure. In this embodiment, the needle trajectory 204 passes through the medical instrument guide member 203, and the arrangement of the medical instrument guide member 203, probe housing 900, clamping feature 908, button 910, and ultrasound cable 101 provides an unobstructed view as the needle passes through the medical instrument guide member 203 and enters the patient's anatomical structure, while also providing clearance at the rear of the ultrasound probe for manipulating the needle. In this imaging arrangement, the fields of view (FOV) 205 of the two ultrasound arrays overlap along the needle trajectory 204, thereby providing independent views of the needle from two different advantageous points.

[0041] Figure 11 shows an exemplary embodiment that improves the visibility of the needle by reducing the acoustic incidence angle to the medical instrument compared to the embodiments in Figures 4A to 4C. The multi-array ultrasound probe in Figures 9A to 9B is drawn with the acoustic imaging plane captured by each of the two ultrasound transducer arrays 202, and the needle 1100 is located on the medical instrument guide member 203. Each of the two ultrasound transducer arrays 202 transmits sound along the central axis 1102 of the ultrasound transducer array and has an external acquisition limit 1104 and an internal acquisition limit 1106, allowing sound to be transmitted to the anatomical structure of the subject imaged between them. The acoustic intensity of the needle in the ultrasound image depends on the acoustic incidence angle to the needle 1100. The acoustic incidence angle to the needle 1100 changes with depth, but the main correlation measurement point is at the shallowest acoustic needle depth 1108, which is within the range of the external acquisition limit 1104 and the internal acquisition limit 1106. At the shallowest acoustic needle depth 1108, the minimum acoustic incidence angle 1114 is used as a determinant of needle visibility capability, where a large minimum acoustic incidence angle 1114 (for example, greater than 75 degrees) produces finite needle visibility capability, a small minimum acoustic incidence angle 1114 (for example, less than 50 degrees) produces a remarkably improved visibility effect, and 0 degrees (the needle is perpendicular to the axis 1102 through which sound propagates) produces strong reflection and visibility in a certain direction (in some cases, producing the strongest reflection and optimal visibility). In some embodiments, one or more of the ultrasonic transducer arrays 202 are rotated by an array rotation angle 1110 to produce a lower minimum acoustic incidence angle 1114 (for example, as shown in Figures 4A-4C) for arrays positioned parallel to the subject's skin lines. In some embodiments, one or more ultrasonic transducers in the ultrasonic transducer array transmit and receive ultrasonic energy along an angle 1112 with respect to the central axis 1102 of the ultrasonic transducer array using multi-angle beam steering, thereby reducing the minimum acoustic incidence angle 1114.When one or more ultrasonic transducer arrays 202 are rotated and one or more acoustically transparent layers (e.g., the central acoustically transparent layer 904, the outermost transparent layer 902, and the innermost transparent layer 906 shown in Figure 11) are positioned to "fill" the remaining space between the ultrasonic transducer arrays 202 and the patient's anatomical structures, acoustic reverberation resulting from reflections within the probe housing can degrade the final ultrasonic image and blur or distort anatomical information. In some embodiments, the surface of the acoustically transparent layer adjacent to the instrument guide member 1116 is inclined non-parallel to the elevation direction of one or more ultrasonic transducer arrays 202, thereby guiding acoustic reflections away from one or more ultrasonic transducer arrays 202. In some embodiments, the material located between the acoustically transparent layer adjacent to the instrument guide member 1116 and the medical instrument guide member 203 has a greater acoustic attenuation rate than the central acoustically transparent layer 904 and an acoustic impedance that is within 50% of the acoustic impedance of the central acoustically transparent layer 904.

[0042] Embodiments of the present invention further include a computer-readable medium, which includes one or more computer files, which include a set of computer-executable instructions, used to perform one or more calculations, steps, processes, and operations described herein and / or explained herein. In exemplary embodiments, files may be stored sequentially or discontinuously on the computer-readable medium. Embodiments may also include a computer program product, which includes computer files, which may be in the form of a computer-readable medium containing computer files, and which is optionally made available to consumers by packaging or, alternatively, by electronic distribution. As used in the context herein, “computer-readable medium” is a non-temporary computer-readable medium and includes any type of computer memory, such as floppy disks, common hard disks, CD-ROMs, flash ROMs, non-volatile ROMs, electrically erasable programmable read-only memory (EEPROMs), and RAMs. In an exemplary embodiment, a computer-readable medium has an instruction set stored therein, and when the instruction set is executed by a processor, the processor causes the processor to perform a task based on data stored in an electronic database or memory as described herein. The processor may implement this process by any program or any equivalent program discussed herein.

[0043] In other embodiments of the present invention, the file containing the computer-executable instruction set may be stored in computer-readable memory on a single computer or distributed across multiple computers. Those skilled in the art will see from this disclosure that the present invention may be implemented by hardware or firmware in addition to software. Therefore, as used herein, the operations of the present invention can be implemented in a system comprising a combination of software, hardware, or firmware.

[0044] Embodiments of this disclosure include one or more computers or devices loaded with a set of computer-executable instructions described herein. The computers or devices may be general-purpose computers, dedicated computers, or other programmable data processing devices for generating specific machines, thereby enabling one or more computers or devices to be directed and configured to perform the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or calculation routines of this disclosure. A computer or device performing a specified calculation, process, step, operation, algorithm, statistical method, formula, or calculation routine of this disclosure may include at least one processing element, such as a central processing unit (i.e., a processor), and computer-readable memory, which may include random access memory (RAM) or read-only memory (ROM). Computer-executable instructions may be embedded in computer hardware or stored in computer-readable memory, thereby enabling a computer or device to perform one or more of the calculations, steps, processes, and operations described and / or mentioned herein.

[0045] Other embodiments of the present disclosure include a computer system for performing the computer implementation of the present disclosure. The computer system may include a processor for executing computer-executable instructions, one or more electronic databases containing the data or information described herein, an input / output interface or user interface, and an instruction set (e.g., software) for performing the method. The computer system may include a standalone computer such as a desktop computer, a portable computer such as a tablet computer, notebook computer, PDA, or smartphone, or a set of computers connected via a network including a client-server configuration and one or more database servers. The network may use any suitable network protocol including IP, UDP, or ICMP, and may be any suitable wired or wireless network including any local area network, wide area network, Internet, telecommunications network, Wi-Fi-supporting network, or Bluetooth-supporting network. In one embodiment, the computer system includes a central computer connected to the Internet, which has computer-executable instructions stored in memory operably connected to an internal electronic database. The central computer may perform the computer implementation based on inputs and instructions received from remote computers via the Internet. The central computer may be used as a server, and the remote computer may be used as a client computer, thereby establishing a server-client relationship, and the client computer can send searches and receive output from the server over the network.

[0046] The input / output interface may include a graphical user interface (GUI) that can be used in conjunction with computer-executable code and electronic databases. The graphical user interface may enable the user to perform these tasks using text fields, checkboxes, pull-downs, command buttons, etc. Those skilled in the art will understand how such graphical features are implemented to perform the tasks of this disclosure. The user interface may optionally be accessed via a computer connected to the Internet. In one embodiment, the user interface can be accessed by entering an Internet address via an industrial standard web browser and logging into a web page. A remote computer (client computer) may then operate the user interface by accessing the web page and sending searches or receiving output from the server over the network.

[0047] The present invention has been described in detail above with reference to specific embodiments having various features. As can be seen by those skilled in the art, various changes and modifications can be made in practice of the present invention without departing from the scope or spirit of the invention. Those skilled in the art will recognize that the disclosed features can be used individually, in any combination, or omitted, depending on the requirements and norms of a given use or design. Where an embodiment refers to "including" some features, it should be understood that the embodiment may be "consisting of any one or more features" or "basically consisting of any one or more features." Other embodiments of the present invention will be apparent to those skilled in the art by considering the specification and practice of the present invention.

[0048] Where a range of values ​​is provided herein, the values ​​between the upper and lower limits of that range are also specifically disclosed. These smaller upper and lower limits may or may not be included in the range, independently of each other. The singular forms “one,” “one,” and “the said” include plural references unless the context explicitly indicates otherwise. The specification and examples are illustrative in nature, and any variations that do not depart from the essence of the invention are within the scope of the invention. Furthermore, all references cited herein are incorporated herein by reference and are intended to provide an effective way to supplement the possible disclosures of the invention and to provide background detailing the general level of art in this field.

[0049] As used herein, the term “about” refers to the value plus or minus five units (e.g., a percentage).

[0050] Any reference in the specification to “several examples,” “example,” “one example,” or “other examples” means that certain features, structures, or properties described by reference to the examples are included in at least some examples of the present invention, but not necessarily in all examples.

[0051] As used herein, the terms “substantially” and “effectively” refer to content that is readily apparent to those skilled in the art.

[0052] Furthermore, the words and terms used in this specification should not be interpreted restrictively, but rather as being used solely for illustrative purposes.

[0053] While some illustrations and drawings may approach accurate proportions, many are not intended to adopt precise proportions.

[0054] It should be understood that the details described herein are not intended to limit the uses of the present invention.

[0055] Furthermore, it should be understood that the present invention can be implemented or practiced in various forms, and can be realized in embodiments other than those described above.

[0056] As used herein, the term “medical device retaining component” means, as understood by those skilled in the art, clips, belts, bands, pins and buckles, and any component that restrains the movement of a medical device.

[0057] As used herein, the term “medical device” means needles, catheters, trocars, ablation devices, cutting devices, therapeutic applicators, and other medical devices as understood by those skilled in the art.

Claims

1. Ultrasonic imaging equipment, Includes a probe housing containing two or more ultrasonic transducer arrays, A physical gap of at least 1 mm is interposed between the two or more ultrasonic transducer arrays. The physical gap is positioned to be used for inserting a medical instrument having an in-plane orientation with respect to the ultrasound imaging plane, and the size of the physical gap is set to accommodate the medical instrument for insertion into the patient's anatomical structure. The ultrasound imaging device further includes a medical instrument guide member located in or adjacent to the physical gap, wherein the probe housing is located in the physical gap.

2. The ultrasound imaging device according to claim 1, wherein the two or more ultrasound transducer arrays are separated from the patient's anatomical structure by one or more intervening acoustic transmission layers.

3. The ultrasound imaging apparatus according to claim 2, wherein the two or more ultrasound transducer arrays do not directly and physically contact the anatomical structures of the patient.

4. The ultrasonic imaging apparatus according to claim 2, wherein the one or more interposed acoustic transmission layers include a patient contact interface and an acoustic filling material.

5. The ultrasound imaging apparatus according to claim 4, wherein the patient contact interface is composed of one or more types of rigid, semi-rigid, or substantially rigid materials.

6. The ultrasound imaging apparatus according to claim 4, wherein the patient contact interface is composed of one or more elastic, semi-elastic, or substantially elastic materials.

7. The ultrasonic imaging apparatus according to claim 4, wherein the one or more interposed acoustic transmission layers include an ultrasonic transducer array lens coating.

8. The ultrasonic imaging apparatus according to claim 2, wherein one or more surfaces of the interposed acoustic transmission layer are inclined non-parallel to the elevation plane of the one or more ultrasonic transducer arrays.

9. The ultrasonic imaging apparatus according to claim 2, wherein the material in contact with one or more surfaces of the one or more interposed acoustic transmission layers has a greater acoustic attenuation rate than at least one of the one or more interposed acoustic transmission layers.

10. The ultrasonic imaging apparatus according to claim 2, wherein the material in contact with one or more surfaces of the one or more interposed acoustic transparent layers has an acoustic impedance that is within 50% of the acoustic impedance of at least one of the one or more interposed acoustic transparent layers.

11. The ultrasonic imaging apparatus according to claim 1, wherein each of the two or more ultrasonic transducer arrays provides an acoustic incidence angle of up to 75 degrees at the shallowest intersection between the medical device and the ultrasonic imaging plane.

12. The ultrasonic imaging apparatus according to claim 1, wherein each of the two or more ultrasonic transducer arrays provides an acoustic incidence angle of up to 50 degrees at the shallowest intersection between the medical device and the ultrasonic imaging plane.

13. The ultrasound imaging apparatus according to claim 1, wherein the medical device guide member is disposed within the probe housing to enable the insertion trajectory of a midline medical device.

14. The ultrasonic imaging apparatus according to claim 1, wherein the medical device guide member is integrated with the probe housing.

15. The ultrasonic imaging apparatus according to claim 1, wherein the medical device guide member enables the insertion trajectory of the medical device to be at an angle of 20 degrees or less with respect to the central axis of the medical device guide member.

16. The ultrasound imaging apparatus according to claim 1, wherein the medical instrument guide member is interfaced to the probe housing in a manner that allows for insertion trajectories of para-median and / or oblique medical instruments.

17. The ultrasonic imaging apparatus according to claim 1, wherein the central axes of sound propagation of each of the two or more ultrasonic transducer arrays are different.

18. The ultrasound imaging apparatus according to claim 1, wherein the directions of sound propagation of each of the two or more ultrasound transducer arrays create overlapping view planes at the target location within the patient's anatomical structure.

19. The ultrasound imaging device according to claim 18, wherein the overlapping view plane includes a point where the medical device enters the anatomical structure of the patient.

20. The ultrasonic imaging apparatus according to claim 18, wherein the processor is configured to geometrically reconstruct images from two or more ultrasonic transducer arrays by combining data at spatial locations sampled by more ultrasonic transducer arrays than one of the two or more ultrasonic transducer arrays.

21. The ultrasonic imaging apparatus according to claim 1, wherein the processor controls the image acquisition of the two or more ultrasonic transducer arrays, and the processor interleaves the image acquisition so that the two or more ultrasonic transducer arrays do not acquire images simultaneously.

22. The ultrasound imaging device according to claim 21, wherein, among the two or more ultrasound transducer arrays, the ultrasound transducer array that collects images and the ultrasound transducer array that transmits ultrasound energy to the anatomical structure of the patient are the same.

23. The ultrasound imaging device according to claim 21, wherein, among the two or more ultrasound transducer arrays, the ultrasound transducer array that collects images and the ultrasound transducer array that transmits ultrasound energy to the anatomical structure of the patient are different.

24. The ultrasonic imaging apparatus according to claim 1, wherein the processor controls the propagation direction of sound waves from the two or more ultrasonic transducer arrays using electron beam steering so that the propagation direction is at one or more non-zero angles with respect to the central axis of the probe housing, the central axis of the two or more ultrasonic transducer arrays, or the central axis of the probe housing and the two or more ultrasonic transducer arrays.

25. The ultrasonic imaging apparatus according to claim 1, wherein the medical instrument holding component is mechanically interfaced with the probe housing and the medical instrument guide member to restrict the medical instrument to a trajectory in a plane.

26. The ultrasound imaging apparatus according to claim 1, wherein the medical instrument holding component is mechanically interfaced with the probe housing and the medical instrument guide member to maintain the alignment of the medical instrument with the target position within the patient's anatomical structure.

27. The ultrasound imaging apparatus according to claim 1, wherein the medical device holding component is interfaced to the probe housing in a manner that allows it to be detachably connected, and a quick-release mechanism is provided for separating the medical device from the probe housing.

28. The ultrasonic imaging device according to claim 1, further comprising a processor, the processor implementing a medical device detection algorithm to detect an image sample that depicts the medical device.

29. The ultrasound imaging apparatus according to claim 28, wherein the processor transfers and superimposes the position of a medical device on a graphic display unit onto an ultrasound image displayed on the graphic display unit by adjusting pixel intensity, coloring pixels, superimposing graphics, or a combination thereof.

30. The ultrasound imaging apparatus according to claim 28, wherein the medical device is a hyperechoic medical device, and the medical device detection algorithm detects samples corresponding to intensity regions and motion trajectories that correspond to the insertion of the medical device into the patient's anatomical structure by distinguishing between the hyperechoic medical device and tissue echoes based on spatiotemporal analysis of continuous image data.

31. The ultrasonic imaging device according to claim 28, wherein the processor adaptively rearranges the direction of sound propagation of the two or more ultrasonic transducer arrays based on the output of the medical device detection algorithm to optimize sensitivity to the medical device.

32. The ultrasound imaging apparatus according to claim 1, wherein the probe housing includes an electronic component, which measures changes in the spatial position of the two or more ultrasound transducer arrays along the anatomical structure of the patient during image acquisition.

33. The ultrasonic imaging apparatus according to claim 32, wherein the processor reconstructs volumetric image data according to a series of two-dimensional images having discrete spatial positions captured by the two or more ultrasonic transducer arrays.

34. The ultrasonic imaging apparatus according to claim 32, wherein the volumetric image data is rendered on a graphic display unit.

35. The ultrasound imaging apparatus according to claim 1, wherein the probe housing includes one or more user gripping members, the one or more user gripping members being positioned to avoid obstructing the insertion trajectory of a medical device.

36. The ultrasound imaging device according to claim 35, wherein the one or more user gripping members are positioned to avoid obstructing the visual path to the point where the medical device contacts the patient's anatomical structure.

37. The ultrasound imaging device according to claim 35, wherein the medical device is one or more of a needle, a catheter, a trocar, an ablation device, a cutting device, and a treatment applicator.

38. The ultrasound imaging apparatus according to claim 1, wherein the probe housing includes one or more button elements, the one or more button elements being positioned to avoid interfering with the insertion trajectory of a medical device.

39. The ultrasound imaging device according to claim 38, wherein the one or more button elements are positioned to avoid obstructing the visual path to the point where the medical device contacts the patient's anatomical structure.

40. The ultrasound imaging apparatus according to claim 38, wherein the medical device is one or more of the following: a needle, a catheter, a trocar, an ablation device, a cutting device, and a treatment applicator.

Images