Hands-free fixing system for ultrasonic transducers

Abstract

This system provides a medical device for attaching an ultrasound scanning transducer to the body during needle injection. [Solution] The system provides a hands-free image guide for advancing the needle, offers dimensional specifications compatible with sterile workflows, minimizes field of view obstruction, and maximizes needle advance space. In embodiments, the present invention interfaces with an ultrasound probe to stabilize the probe against the patient's anatomical structure during real-time imaging, reposition the probe, and provide sufficient working space around the probe for the physician to plan and perform needle insertion.

Description

Detailed Description of the Invention , ,

[0004] , ,

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority and filing date based on the disclosure of U.S. Application No. 63 / 444,524, filed on February 9, 2023. The disclosure of the above application is incorporated herein by reference.

[0002] (Statement Regarding Federally Sponsored Research in the United States) This invention was made with government support, and related assistance was provided by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH), USA, under grant number R44NS120798. The United States Government has certain rights in this invention.

Technical Field

[0003] The present invention relates to an apparatus for attaching an ultrasonic scanning transducer to the body during the needle injection period for medical use.

Background Art

[0004] Needle - guiding operations in the medical field are diverse and include various processes such as lumbar puncture, bone marrow biopsy, acute pain analgesia, and chronic pain treatment injection. The techniques used for injection guidance are various, including palpation - based methods without using any imaging guidance, and methods of guiding in imaging modes such as ultrasound, computed tomography, or fluoroscopy. The palpation method can be performed at the bedside at low cost, but has problems such as a low surgical success rate and a high complication incidence rate. Conventional ultrasonic techniques can improve the surgical success rate and are sometimes surely applied, but have certain limitations including a long learning curve and a workflow obstacle due to the need to perform the operation of the ultrasonic probe and the insertion of the needle (the latter usually requires a two - hand operation) simultaneously. X - ray - based methods such as computed tomography or fluoroscopy have a relatively high success rate, but expose patients to ionizing radiation, increase surgical costs, and such methods usually cannot be performed at the bedside and are not compatible with the workflow limitations in fields such as the emergency department.

[0005] To overcome the limitations of conventional methods in the guiding process of medical needles, the present invention introduces a device for attaching an ultrasound probe to a patient's body, thereby guiding the workflow with interventional needles. In each embodiment, the device can support sterilization operations as a disposable sterile consumable, maintain hands-free imaging contact between the probe and the patient, minimize obstruction of the field of view, and provide needle advancement space related to the anatomical structure of the patient, allowing the clinician to place and advance the needle with one or both hands. Compared to conventional ultrasound technology, such a hands-free method is an advancement, as in conventional ultrasound technology, the clinician needs to grasp the ultrasound imaging transducer with one hand and advance the needle with the other, or complete part of the surgery with one assistant, whereas in this case, the physician can advance the needle with both hands. Preferred embodiments of the present invention are described below. [Overview of the project]

[0006] While the exemplary embodiments described herein possess novel features, no single feature is essential, nor is it the sole determinant of their superior attributes. The following description and drawings specifically illustrate some descriptive embodiments of the present disclosure and show several exemplary forms that can implement various principles of the present disclosure. However, these exemplary examples are not limited to all possible embodiments of the present disclosure. Without limiting the scope of the claims, some beneficial features are summarized below. Other objectives, advantages, and novel features of the present disclosure are described in detail with reference to the following drawings, but these do not limit the invention. [Effects of the Invention]

[0007] In the embodiments, the present invention provides a hands-free needle propulsion video guide, a dimensional specification compatible with sterilization workflows, said dimensional specification minimizes field of view obstruction and maximizes needle propulsion space. In the embodiments, the present invention interfaces with an ultrasound probe to stabilize the probe in the patient's anatomical structure during real-time imaging, to reposition the probe, and to provide sufficient working space around the probe for the physician to plan and perform needle insertion. In each embodiment, the device also supports selectively connecting components to the ultrasound probe to guide the needle trajectory.

[0008] The drawings illustrate specific aspects of several embodiments of the present invention and should not be used to limit or define the invention. The drawings are used in conjunction with the description herein to illustrate some principles of the present invention. To gain a more comprehensive understanding of the essence and merits of the present invention, please refer to the detailed description of the preferred embodiments below in conjunction with the drawings. [Brief explanation of the drawing]

[0009] [Figure 1A] This is a schematic diagram of an exemplary device attached to a patient's anatomical structure and an exemplary ultrasound probe coupled to the device. [Figure 1B] This is a schematic diagram of an exemplary device attached to a patient's anatomical structure and an exemplary ultrasound probe coupled to the device. [Figure 1C] This is a schematic diagram of an exemplary device attached to a patient's anatomical structure and an exemplary ultrasound probe coupled to the device. [Figure 2] In the exemplary application, an exemplary ultrasound probe attached to the apparatus and the patient's anatomical structure is depicted. [Figure 3] This diagram shows a flowchart illustrating how a clinician can use the device described in the present invention to perform needle-guided surgery as an aid. [Figure 4A] This is a schematic diagram of an exemplary device with a rotating component and an exemplary dual-array probe interfaced to the device. [Figure 4B] This is a schematic diagram of an exemplary device with a rotating component and an exemplary dual-array probe interfaced to the device. [Figure 4C] This is a schematic diagram of an exemplary device with a rotating component and an exemplary dual-array probe interfaced to the device. [Figure 5A] This schematic diagram shows an exemplary device for attachment to a patient's anatomical structure and an exemplary ultrasound probe coupled within the device. The schematic diagram shows a device consisting of two base components integrated within a sterile patient drape, with an elastic band on the drape securing the ultrasound probe between the two base components. [Figure 5B] This schematic diagram shows an exemplary device for attachment to a patient's anatomical structure and an exemplary ultrasound probe coupled within the device. The schematic diagram shows a device consisting of two base components integrated within a sterile patient drape, with an elastic band on the drape securing the ultrasound probe between the two base components. [Figure 5C] This schematic diagram shows an exemplary device for attachment to a patient's anatomical structure and an exemplary ultrasound probe coupled within the device. The schematic diagram shows a device consisting of two base components integrated within a sterile patient drape, with an elastic band on the drape securing the ultrasound probe between the two base components. [Figure 5D] This schematic diagram shows an exemplary device for attachment to a patient's anatomical structure and an exemplary ultrasound probe coupled within the device. The schematic diagram shows a device consisting of two base components integrated within a sterile patient drape, with an elastic band on the drape securing the ultrasound probe between the two base components. [Figure 6A] This is a schematic diagram of an exemplary apparatus in which the angle is set by the arrangement of fixed components that interface with the ultrasonic probe. [Figure 6B] This is a schematic diagram of an exemplary apparatus in which the angle is set by the arrangement of fixed components that interface with the ultrasonic probe. [Figure 6C]This is a schematic diagram of an exemplary apparatus in which the angle is set by the arrangement of fixed components that interface with the ultrasonic probe. [Figure 6D] This is a schematic diagram of an exemplary apparatus in which the angle is set by the arrangement of fixed components that interface with the ultrasonic probe. [Figure 7A] This is a schematic diagram of an exemplary fastening component including an acoustically transparent material, an acoustic coupling distribution component, and / or an acoustically transparent adhesive component. The fastening component can be integrated with other fastening components (which may include elastic bands) and a sterile probe drape or sheath. [Figure 7B] This is a schematic diagram of an exemplary fastening component including an acoustically transparent material, an acoustic coupling distribution component, and / or an acoustically transparent adhesive component. The fastening component can be integrated with other fastening components (which may include elastic bands) and a sterile probe drape or sheath. [Figure 8] An exploded view of an exemplary dual-array probe with a U-shaped groove and needle guide insertion member is shown. [Figure 9] This shows an exemplary software platform and an exemplary dual-array probe connected to a medical cart. [Figure 10] The flowchart illustrates how the apparatus of the present invention, using an exemplary dual-array probe with position tracking capabilities, assists a clinician in performing needle-guided surgery. [Modes for carrying out the invention]

[0010] Ultrasound imaging transducer assemblies are used in a variety of medical or clinical applications to realize medical imaging functions. In these non-limiting examples, the ultrasound imaging transducer is installed within the transducer assembly and transmits pulses, tones, sequences, or programmed energy signals to a target location awaiting imaging. Specific examples include one or more ultrasound transducer elements that transmit ultrasound signals into the patient's body, detect return signals, and form a computer-generated image of the target area. Different ultrasound imaging modes can be employed according to specific applications and designs known to those skilled in the art. The present invention can be used in, but is not limited to, medical ultrasound applications. As will be apparent to those skilled in the art, multiple types of transducers, signal transmitters and / or receivers and other arrays can also benefit from the present invention, and the present invention encompasses these. A preferred embodiment of the present invention describes a needle guide. As will be understood to those skilled in the art, the present invention can guide a variety of medical devices, including, but not limited to, catheters, trocars, ablation devices, or therapeutic applicators. In preferred embodiments, the present invention can be used in conjunction with the system and method previously published by Mauldin et al. (PCT / US2019 / 012622), which is incorporated herein by reference and is used for automated three-dimensional detection, guiding, and visualization of ultrasound-based therapeutic guidance processes.

[0011] In an example of a medical application for the needle guide of the present invention described herein, one purpose of the device is to stabilize an ultrasound probe against a patient's anatomical structure, allowing the physician to release their hand from the device while maintaining acoustic coupling and being used for image guidance of needle insertion. In an example, additional goals include minimizing visual occlusion of deep anatomical structures related to a medical procedure, minimizing needle insertion site manipulation occlusion, repositioning and reorienting (in some aspects simple) the ultrasound probe, and compatibility with a sterilization workflow. In an example, the present invention consists of one or more base components removably attached to a patient in proximity to or adjacent to a patient's anatomical structure related to a medical procedure. The base component can include a rigid, semi-rigid, or substantially rigid material such as plastic or metal and provides an anchor point to secure the ultrasound transducer in contact with the patient's anatomical structure. In an example, the present invention includes one or more fixation components attachable to one or more base components and the ultrasound transducer and providing an orientation force to maintain contact between the ultrasound transducer and the patient's anatomical structure. The one or more fixation components can include a flexible or substantially flexible material such as rubber, some plastics, or a woven fabric, or a rigid, semi-rigid, or substantially rigid material such as plastic or metal. In an example, the present invention provides a mechanism for adjusting the position of an ultrasound transducer attached to the patient by the device, the mechanism can include the arrangement of one or more base components and one or more fixation components, and the one or more base components and one or more fixation components are designed for the user to manually position the ultrasound probe within the device by applying a force to the handle of the ultrasound probe, one or more fixation components, or one or more base components.

[0012] In an exemplary embodiment, the device is shown in FIG. 1A. The device has a base component 100 that is attached to the patient's anatomical structure. Non-limiting examples of ways to attach the base component 100 to the patient's anatomical structure include attaching an adhesive layer to the patient contact side, using straps, suction mechanisms, magnetic mechanisms to attach around the patient's anatomical structure, or fixing the position of 100 to the patient's anatomical structure. In this non-limiting example, the base component is depicted as having a rounded-corner rectangular shape, although other shapes can be envisioned. The design can be an arrangement that is qualified for a particular patient's anatomical structure and provides a visual operation space and a needle advancement space including, but not limited to, circular or semi-circular shapes The reference mark 101 can provide measurements for surgical planning and probe positioning to the user.In each aspect, the component 102 can be used to attach a rubber band 103 or strap along the perimeter of a device that secures an ultrasonic probe within the device.

[0013] In a non-limiting embodiment shown in FIG. 1B, the device can be qualified for a sterile workflow where the device is applied to sterilized portions of the patient's anatomical structure 104 and can be covered for imaging exploration and needle insertion. A sterile drape (e.g., a surgical drape) that covers the non-sterile patient anatomical structure is coupled to or incorporated into the outer edge of the device 100. In an embodiment, the drape can have the same dimensions and materials used during epidural and spinal anesthesia or other similar needle-guided procedures.

[0014] In an unrestricted embodiment shown in Figure 1C, the ultrasonic probe 106 and ultrasonic cable 107 can be integrated into the device and held within a fixed band 103 by a positioning guide 108 that restricts lateral movement. The positioning guide 108 can be directly coupled into the ultrasonic probe 106, or, in other unrestricted embodiments, can consist of a sterile component clamped in the ultrasonic probe housing. In an unrestricted embodiment, the ultrasonic signal cable 107 connects the ultrasonic probe 106 to a computer processor, where alternative embodiments include wirelessly transmitting the signal, or directly coupling the computer processor and display into the probe housing.

[0015] Figure 2 shows a schematic diagram of surgery relating to the anatomical structures of the patient's spine. In this non-limiting embodiment, a medical-grade adhesive is included on the underside of the device 100, which is designed to secure the base component of the device to the patient's skin and is centrally located above the area where the needle will be inserted. After the physician has explored the sterile anatomical structure with the ultrasound probe 106, the physician positions the ultrasound probe appropriately and inserts the needle with one or both hands into the “window” provided by the device 100.

[0016] Figure 3 shows a flowchart of one embodiment of the present invention for clinical needle-guided surgery. In block 301, the user first sterilizes the patient's anatomical structures around the desired injection site. In block 302, the user places the sterile drape component 105 of the device over the non-sterile patient's anatomical structures, thereby leaving an open window over the sterile anatomical structures. The base component of the device 100 is then attached to the patient's anatomical structures by an adhesive layer bonded within the component. In block 303, as shown in Figure 2, the ultrasound probe is integrated into the device at the desired imaging position and coupled to the patient's body using an ultrasound coupling gel or other lubricant compatible with medical ultrasound, as well as is well known to those skilled in the art. Next, in block 304, the user begins image acquisition. In block 305, the ultrasound image acquisition is transmitted to a computer system, and the reconstructed image is displayed on a monitor in real time. In block 306, the user can manually move the ultrasound probe 106 within the device until the desired anatomical structure is in the imaging plane. In block 307, the user releases their hands from the ultrasound probe 106, fixes the probe to the device 100, and continues to view the real-time anatomical image. In block 308, the user inserts the needle with one or both hands and monitors the trajectory of the needle as it enters the real-time imaging display. In block 309, if the real-time imaging display indicates that the needle is not in view, the user can reposition the ultrasound probe 106 within the device 100 to regain visibility of the needle. In block 310, the user completes the procedure by advancing the needle to the target site and confirms it with the real-time image display.

[0017] In the non-limiting embodiment shown in Figure 4A, a unique separate array ultrasonic probe 400 is integrated into the apparatus 100, or otherwise attached to or connected to the apparatus, and the unique separate array ultrasonic probe 400 has a U-shaped groove 402 for advancing the needle in a plane (the relevant details are found in U.S. Patent Application No. 17 / 950,399, which is incorporated herein by reference). The device is held within a fixed band 103 by a positioning guide 403 that restricts lateral movement. The positioning guide 403 can be directly coupled into the ultrasonic probe 400, or in other non-limiting embodiments, it can consist of a sterile component clamped in the ultrasonic probe housing. In non-limiting embodiments, an ultrasonic signal cable 401 connects the ultrasonic probe 400 to a computer processor, but alternative embodiments may include wireless transmission of signals, or direct coupling of the computer processor and display within the probe housing. In non-limiting embodiments, the interface between the ultrasound probe 400 and the ultrasound signal cable 401 is angled relative to the ultrasound probe body 400 to minimize the perpendicular contour of the ultrasound probe to the patient's anatomical structure, improve stability within the device, and / or maximize the surgical working space around the base of the ultrasound probe 400. Non-limiting examples include probe-cable interfaces that are angled between 30 and 90 degrees with respect to the probe body, probe-cable interfaces with central or eccentric angle adjustment along the front or rear of the ultrasound probe body, and probe-cable interfaces with central or eccentric angle adjustment along either side of the probe body.

[0018] In a preferred embodiment, the apparatus is depicted in Figure 4B. In this non-limiting embodiment, the base component is circular, but can be designed in other configurations to suit the anatomical structure of a particular patient and to provide a visual manipulation space and a needle propulsion space. A second component 404 provides a rotating ring, which allows the internal components of the apparatus to rotate by the rotating ring to reposition the ultrasound probe, while simultaneously holding the base component 100 fixed to the patient. Reference marks 405 and 406 indicate the degree of rotation to the user. In a non-limiting embodiment, a position tracking clip 407 for fixing the ultrasound probe within the apparatus is attached to component 102 on the base device. In a non-limiting embodiment, the position tracking clip 407 includes an electronic component that can identify the probe position within the clip. A reference mark 408 can provide position indication along the position tracking clip 407. Figure 4C depicts the ultrasound probe 400 coupled in the apparatus. The ultrasound probe 400 can be coupled with a sensor, which can read the position of the probe within a position tracking clip 407 and transmit these signals to an imaging system via an ultrasound probe cable 401. In a preferred embodiment, position measurement is achieved by a magnetic / inductive or resistive method. In such embodiments, the passive and non-self-powered elements of the sensor system are coupled in the position tracking clip 407, and the actively powered sensor is coupled in the ultrasound probe 400. In a non-limiting embodiment, a needle guide 409 supplied with the device is inserted into a U-shaped groove 402 of the ultrasound probe 400 to guide the trajectory of the needle within the device and facilitate needle delivery in the plane of the surgical space.

[0019] In an exemplary embodiment, the device is depicted in Figure 5A. The device has two base components 500 and 502 that are attached to a patient drape 504. Non-limiting examples of how the base components 500 and 502 are attached to the patient drape include methods of bonding an adhesive layer to the patient contact side, a suction mechanism, a magnetic mechanism, or other methods of attaching the positions of 500 and 502 to the patient drape. In this non-limiting example, the base components are depicted as having a circular shape that is suitable for the top and bottom positions of the patient drape opening 506, but other shapes and positions that are bonded along the patient drape opening 506 can be envisioned. The design may be an arrangement that is suitable for the anatomical structure of a particular patient and provides a visual manipulation space and a needle propulsion space, and may include, but is not limited to, a circular or semicircular shape. The fixing component 508 is used to secure the elastic band 510, strap, or other flexible material, and the two base components 500 and 502 are used to connect to the patient's drape opening 506 to secure the ultrasonic transducer.

[0020] In an unspecified embodiment shown in Figure 5B, the ultrasonic probe 512 and ultrasonic signal cable 514 can be integrated into the device and held within a fixed band 510 by a positioning guide 516 that restricts lateral movement. The positioning guide 516 can be directly coupled into the ultrasonic probe 512, or in other unspecified embodiments, it can consist of a sterile component clamped in the ultrasonic probe housing, or a sterile component attached to an ultrasonic probe sheath that can be attached to the ultrasonic probe housing. In an unspecified embodiment, the ultrasonic signal cable 514 connects the ultrasonic probe 512 to a computer processor, where alternative embodiments include wirelessly transmitting the signal, or directly coupling the computer processor and display into the probe housing.

[0021] In the non-limiting embodiments shown in Figure 5C, the bases 500 and 502 can be adapted to a sterile workflow, where they can be applied to a sterile portion of the patient's anatomical structure 506 and covered for imaging exploration and needle insertion, and a sterile drape 504 (e.g., a surgical drape) covering a non-sterile patient's anatomical structure is coupled to or within the base components 500 and 502. In the embodiments, the drape may have the same dimensions and material as used during epidural and spinal anesthesia or other similar needle-guided surgery. Mounting components 518 and 520 are coupled within the patient drape to secure the drape 504 to the patient's anatomical structure. Non-limiting examples of mounting components 518 and 520 include adhesive layers, straps, suction mechanisms, magnetic mechanisms, or other methods for securing the patient drape 504 to the patient's anatomical structure.

[0022] In a non-limiting embodiment shown in Figure 5D, the base components 500 and 502 are attached to the patient drape 504 using mounting components 522 and 524, and the patient drape 504 is attached to the patient's anatomical structure using mounting components 518 and 520. Non-limiting examples of mounting components 522 and 524 include adhesive layers, straps, suction mechanisms, magnetic mechanisms, or other methods for securing the patient drape 504 to the patient's anatomical structure.

[0023] In a non-limiting embodiment shown in Figure 6A, a unique separate array ultrasound probe 512 (related to U.S. Patent Application No. 17 / 950,399) having a groove for advancing a needle in a plane is fixed within the device by an elastic band 510 and positioned to maintain a certain angle, for example by manual operation, so that the needle 600 can penetrate the patient's anatomical structure 602 at a flat angle. In Figure 6B, the angle of the ultrasound probe 512 within the positioning device 516 can be readjusted (for example by manual operation) so that the needle 600 can penetrate the patient's anatomical structure 602 at a certain angle. A non-limiting example includes a device for adjusting the angle of the needle to be between 0 and 20 degrees relative to the entering flat angle, as shown in Figure 6A. Figure 6C is a front view of the contents shown in Figure 6A, where the needle 600 is positioned in a U-shaped groove 604 and used to advance the needle in a plane. Figure 6D shows a front view of the configuration shown in Figure 6B, where the needle angle has already been adjusted by user operation, and the fixing component 510 and positioning component 516 ensure that the ultrasound probe is stably in contact with the patient's anatomical structure 602.

[0024] Figure 7A shows a component-level diagram of an exemplary fixed component designed as a dual-array housing 700. Figure 7B shows a component-level exploded view of the exemplary dual-array housing 700. The imaging device may include a dual ultrasonic array 702 and related electromechanical components well known to those skilled in the art, enclosed in a mechanical housing. The imaging device may include an acoustic lens 704 and an acoustic couplant 706, which may be separate components or integrated with other mechanical housings and used to optimize the transfer of acoustic energy from the array 702. In non-limiting embodiments, the lens 704 and the acoustic couplant 706 may include disposable sterile components used to apply a sterile barrier between the ultrasonic array 702 and the patient's anatomical structures. Instead of the two ultrasonic arrays 702, additional ultrasonic arrays, matrix transducer arrays, or capacitive micromachine ultrasonic transducer (C-MUT) arrays may be used to improve the field of view or improve the image acquisition speed. A disposable sterile assembly 708 can enclose an assembly of the array 702, acoustic couplant 706, and lens 704. In a non-limiting embodiment, the probe housing may include a disposable sterile component used to apply a sterile barrier between the ultrasonic array 702 and the patient's anatomical structure. In a non-limiting embodiment, the disposable sterile assembly 708 may be acoustically coupled to the lens 704 using an acoustic coupling component 710, which may include an adhesive film, an aqueous material such as ultrasonic gel, an oil, or a sponge designed to retain and distribute an aqueous material or oil. In a non-limiting embodiment, the probe housing 708 may include a fixing component, which is attached to the sterile probe drape by an adhesive material that binds within the disposable sterile assembly 708, for example. In a non-limiting embodiment, the disposable sterile assembly 708 may include a fixing component 712 designed to secure a dual array housing 700 within the disposable sterile assembly 708.In each embodiment, the disposable needle guide 409 is inserted into the disposable sterile assembly 708 to provide a sterile or non-sterile needle trajectory guide. In a non-limiting embodiment, the disposable sterile assembly 708 may include an acoustic coupling component 714 that provides an acoustic transmission medium between the disposable sterile assembly 708 and the patient's anatomical structure. The acoustic coupling component may include an aqueous material such as an adhesive film or acoustic gel, an oil, or a sponge designed to hold and distribute the aqueous material or oil.

[0025] Figure 8 shows an exploded view at the component level of an exemplary dual-array ultrasound probe 400. The imaging device may include a dual ultrasound array 800 and related electromechanical components well known to those skilled in the art, enclosed in a mechanical housing. The ultrasound probe 400 electronic device may be coupled with a position encoder, which relays its signals to a computer processor via an ultrasound probe cable 401, directing linear position changes of a linear actuator, image acquisition from the ultrasound array 800, and signal or image processing steps applied to the acquired ultrasound image signals. The imaging device may include an acoustic lens and an acoustic couplant 801, which may be separate components or integrated with other mechanical housings and used to optimize the transmission of acoustic energy from the array 800. In non-limiting embodiments, the lens and acoustic couplant 801 may include disposable sterile components used to apply a sterile barrier between the ultrasound probe 400 and the patient. Instead of the two ultrasound arrays 800, additional ultrasound arrays, matrix transducer arrays, or C-MUT arrays may be used to improve the field of view or improve the image acquisition speed. In each embodiment, a disposable needle guide 409 is inserted into the probe housing and provides a sterile or non-sterile needle trajectory guide. The needle guide 409 can restrain the needle at the base position of the U-shaped groove 402, ensuring the needle is precisely positioned in the desired anatomical location and within the ultrasound imaging plane. The needle guide 409 allows the needle to pass through the length of the U-shaped groove 402 and be removed from anatomical structures and imaging devices 400. The needle guide 409 can be configured to restrict or allow needle removal by mechanism, including, but not limited to, rotation, release, or removal of the needle guide. The entire ultrasound probe assembly can be covered by a sterile sheath before being coupled in a stabilizing device to support sterile surgery.

[0026] In the exemplary embodiment shown in Figure 9, the ultrasound probe 400 is connected to a mobile cart 900 by an electrical signal cable 401, allowing the imaging device to be moved to the bedside and positioned in the required or desired orientation for acquiring images of the patient's anatomical structure. The cart 900 may include a housing 901, which may include a computer processor and monitor 902, a battery 903, and other necessary related electronic devices well known to those skilled in the art for powering the imaging device 400 and communicating with the imaging device 400. The cart 900 may have additional input / output devices such as a keyboard, mouse, or monitor 902, which may be a touchscreen display. The monitor 902 is position-adjustable around the cart to orient the imaging device 400 and the monitor to various relative positions for needle-guided surgery. In a preferred embodiment, the housing 901 may simultaneously include the monitor 902, the computer processor, and the ultrasound front-end electronic device. The computer processor within the housing 901 is used to execute the ultrasound signal and form the image processing steps necessary for reconstructing the ultrasound image that can be displayed on the monitor 602. Such processing steps are known to those skilled in the field of medical ultrasound and include, but are not limited to, beamforming, bandpass filtering, scan conversion, and image rendering. Two-dimensional and three-dimensional images are rendered using various techniques, including simultaneous display, as described, for example, in U.S. Patent No. 11,504,095 by Mauldin et al. (incorporated herein by reference). In a preferred embodiment, a computer processor in the housing 601 can receive signals from the ultrasound probe 400 indicating the probe's position within the apparatus and is used to interpret the spatial position of acquired real-time image data. In a preferred embodiment, the spatial position calibration of the imaging data can be used to reconstruct a three-dimensional ultrasound image of a fluoroscopic image functionally equivalent to a bone anatomical structure.

[0027] Figure 10 shows a flowchart of an exemplary embodiment of the present invention for clinical needle-guided surgery. In frame 1001, the user first attaches the device base component 100 to the patient at the desired needle insertion position. In block 1002, as shown in Figure 4, the ultrasound probe is integrated into the device at the desired imaging position and coupled to the patient's body using an ultrasound coupling gel or other lubricant compatible with medical ultrasound, which is well known to those skilled in the art. Next, in block 1003, the user starts image acquisition. Startup can be achieved by the monitor 902, a user interface button, or other methods known to those skilled in the art. In block 1004, the ultrasound image acquisition is transmitted to the computer system in the housing 901 and the reconstructed image is displayed on the monitor 902. In an embodiment with a position tracking clip 407, as shown in Figure 4C, the user can manually move the probe along the position tracking clip to acquire a three-dimensional image. In the same embodiment, in block 1005, the position of the ultrasound probe 400 is calibrated during the image acquisition period to construct a three-dimensional image volume. In block 1006, the real-time image is calibrated against, for example, an ideal imaging anatomical structure for surgery, which is derived and displayed from three-dimensional ultrasound data or other representations of the anatomical structure. In block 1007, it is determined whether the current image meets the criteria indicating the alignment of the needle guide and the needle injection target. This evaluation can be automatically generated by a processing algorithm executed on a computer system, for example, as described in U.S. Patent No. 11,504,095 by Mauldin et al. (incorporated herein by reference), or it can be achieved by the user visually evaluating the rendered imaging results. If these criteria are not met, block 1008 provides guidance to resolve any challenges that may arise during the surgery by guiding the user to adjust the position of the ultrasound probe 400 to provide better alignment with the target anatomical structure. If the criteria are met, block 1009 guides the user to continue with needle placement.In either embodiment, the user activates needle guide mode 1010, which causes the software to switch to imaging mode, enhancing real-time visualization of the needle during insertion into 1011. Finally, in block 1012, as the user advances the needle through needle guide 409 and the needle advances toward the needle target, an ultrasound image rendering is visualized and displayed on monitor 901.

[0028] Embodiments of the present invention further include a computer-readable medium containing one or more computer files, the one or more computer files containing a set of computer-executable instructions used to perform one or more of the calculations, steps, processes and operations described and / or stated herein. In exemplary embodiments, the files may be stored in the computer-readable medium contiguously or discontinuously. Embodiments may also include a computer program product, the computer program product including the form of a computer file or a computer-readable medium containing a computer file, and optionally made available to consumers by packaging or optionally made available to consumers by electronic distribution. As used in the context of this specification, “computer-readable medium” is a non-temporary computer-readable medium and includes any type of computer memory, such as floppy disks, conventional hard disks, CD-ROMs, flash ROMs, non-volatile ROMs, electrically erasable programmable read-only memory (EEPROMs), and RAMs. In exemplary embodiments, the computer-readable medium has a set of instructions stored therein, and when the set of instructions 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 can implement the process by any program or any equivalent program discussed in this disclosure.

[0029] 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.

[0030] 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, and may be configured to produce a particular machine, and one or more computers or devices may be directed to perform the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or calculation routines of this disclosure. The computers or devices performing the designated calculations, processes, steps, operations, algorithms, statistical methods, formulas, or calculation routines of this disclosure may include at least one processing element, for example, a central processing unit (i.e., a processor) and a form of 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 guiding the computers or devices to perform one or more of the calculations, steps, processes, and operations described herein and / or described herein.

[0031] 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 standalone computers such as desktop computers, portable computers such as tablet computers, notebook computers, PDAs, or smartphones, or a group 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 enabled network, or Bluetooth enabled 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 can perform the computer implementation based on inputs and instructions received from remote computers via the Internet. The central computer is used as a server, and remote computers are used as client computers to establish a server-client relationship. The client computers can send searches from the server and receive output from the server via the network.

[0032] The input / output interface may include a graphical user interface (GUI) that can be used in conjunction with computer-executable code and an electronic database. The graphical user interface can allow the user to perform tasks using text fields, checkboxes, pull-down menus, command buttons, etc. Those skilled in the art will understand how such graphical features can be implemented to perform the tasks of the present invention. The user interface can be accessed from any 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. The user interface can then be operated by a remote computer (client computer) that has accessed the web page, sending searches and receiving output from a server via the network connection.

[0033] The present invention has been described in detail above with reference to specific embodiments having various features. As will be understood 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 specifications of a particular use or design. Where an embodiment refers to "including" some features, it should be understood that the embodiment may be replaced with "consisting of any one or more features" or "basically consisting of any one or more features." Other embodiments of the present invention will be obvious to those skilled in the art by considering the specification and practice of the present invention.

[0034] Where numerical ranges are provided herein, the values ​​between the upper and lower limits of those ranges are also specifically disclosed. These smaller upper and lower limits may, independently, be included in or excluded from the range. Unless the context explicitly indicates otherwise, the singular forms "one," "one," and "the" include plural indications. The specification and examples are essentially illustrative, 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, each intended to provide effective means for realizing the disclosure of the invention and to provide background detailing the level of skill of those skilled in the art.

[0035] As used herein, the term “approximately” refers to the value plus or minus five units (e.g., a percentage).

[0036] In this specification, the terms "several examples," "example," "one example," or "other examples" mean that certain features, structures, or properties described with reference to the examples are included in at least some examples of the present invention, but not necessarily in all examples.

[0037] As used herein, the terms “basic” and “basically” refer to content that is easily recognizable to a person skilled in the art.

[0038] The words and terms used herein should not be constrained, but rather used solely for illustrative purposes.

[0039] While some illustrations and drawings can be made to approximate accurate proportions, many are not intended to adopt precise proportions.

[0040] The details described herein should be interpreted as not limiting the uses of the present invention.

[0041] Furthermore, the present invention can be implemented or practiced in various forms, and can also be carried out in forms other than those described above.

Claims

1. A system for attaching an ultrasonic transducer to a patient, One or more base components that can be attached to the patient in a manner that is close to or adjacent to the patient's anatomical structure, Including one or more fastening components, The one or more fixing components interface with the ultrasonic transducer and the one or more base components to (a) attach the ultrasonic transducer to the one or more base components in close proximity to or adjacent to the patient's anatomical structure, and (b) substantially maintain acoustic coupling between the ultrasonic transducer and the patient's anatomical structure. A system for attaching an ultrasonic transducer to a patient, characterized in that it allows a user to access approximately 10% to approximately 95% of the patient's anatomical structures adjacent to or near the ultrasonic transducer, so that a needle, probe, or injectable device can be inserted.

2. The system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising a mechanism for adjusting the position of the ultrasonic transducer, wherein the mechanism can cause the ultrasonic transducer to perform at least one of vertical movement, horizontal movement, movement along the diagonal direction of the patient contact surface, and movement at a predetermined angle with respect to the patient contact surface.

3. The system for attaching an ultrasonic transducer to a patient, according to claim 2, wherein the mechanism for adjusting the position of the ultrasonic transducer is capable of adjusting the angle of the ultrasonic transducer with respect to the patient's anatomical structure.

4. The system for attaching an ultrasonic transducer to a patient according to claim 2, wherein the mechanism for adjusting the position of the ultrasonic transducer includes a member that can be operated by a user, thereby substantially maintaining the angle of the ultrasonic transducer with respect to the patient's anatomical structure, or selectively setting the angle of the ultrasonic transducer with respect to the patient's anatomical structure.

5. The system for attaching the ultrasonic transducer according to claim 1 to a patient, characterized in that the one or more fixing components include one or more of a band, a clip, a track, an adhesive, or a case.

6. The system for attaching an ultrasonic transducer to a patient according to claim 5, wherein the trajectory includes at least two elongated members extending between two of the one or more base components, the at least two elongated members being positioned substantially parallel to each other, the at least two elongated members being attached to the ultrasonic transducer, and the ultrasonic transducer being slid along the trajectory between two of the one or more base components.

7. The system for attaching an ultrasonic transducer to a patient according to claim 1, characterized in that the one or more fixing components include (a) an acoustic transmission member between the ultrasonic transducer or probe sheath and (b) a patient contact surface.

8. The system for attaching an ultrasonic transducer to a patient according to claim 7, wherein the acoustic transmission member includes an adhesive film, and the adhesive film temporarily adheres the ultrasonic transducer or the probe sheath to the patient contact surface for gel-free scanning.

9. A system for attaching an ultrasonic transducer to a patient, characterized in that one or more of the aforementioned fixing components are physically integrated with a probe sheath or drape, according to claim 1.

10. The system for attaching an ultrasonic transducer to a patient, according to claim 9, characterized in that the probe sheath or the drape completely or partially covers the ultrasonic transducer and substantially maintains a sterile area.

11. The system for attaching an ultrasonic transducer to a patient, according to claim 1, characterized in that the one or more fixing components include an acoustic transmission component between the ultrasonic transducer and the probe sheath or drape.

12. The system for attaching the ultrasonic transducer according to claim 1 to a patient, characterized in that the one or more fixing components include an acoustic coupling distribution component.

13. The system for attaching an ultrasonic transducer to a patient according to 12, wherein the acoustic coupling distribution component comprises one or more of an absorbent pad, a sponge, or a sealed reservoir, and the acoustic coupling distribution component distributes an acoustic coupling fluid and substantially maintains acoustic contact between the ultrasonic transducer and the patient's anatomical structure.

14. The system for attaching the ultrasonic transducer according to 12 to a patient is characterized in that the acoustic coupling distribution component is completely or partially permeated with water, saline solution, betadine, or acoustic gel.

15. The system for attaching the ultrasonic transducer according to 12 to a patient, characterized in that the acoustic distribution component applies an acoustic coupling fluid along the outer surface of the probe sheath and substantially maintains acoustic contact between the probe sheath and the patient's anatomical structure.

16. The system for attaching an ultrasonic transducer to a patient according to claim 12, characterized in that the acoustic distribution component applies an acoustic coupling fluid along the inner surface of the probe sheath and substantially maintains acoustic contact between the ultrasonic transducer and the probe sheath.

17. A system for attaching an ultrasonic transducer according to claim 1 to a patient, wherein the one or more fixing components provide a hole, opening, or slot configured to receive the needle, the probe, or the injectable device, wherein the hole, opening, or slot substantially aligns or guides the transdermal injection of the needle, the probe, or the injectable device.

18. A system for attaching an ultrasonic transducer to a patient according to claim 1, wherein the one or more base components further include or are attached to a drape, the drape being used to cover all or part of the patient's body that is close to or adjacent to the location where the needle, the probe, or the injectable device is inserted into the patient's body.

19. A system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising a cable connected to the ultrasonic transducer, wherein the cable is oriented relative to the ultrasonic transducer and one or more of the one or more base components, thereby minimizing the perpendicular contour of the ultrasonic transducer to the patient's anatomical structure, stabilizing the ultrasonic transducer and one or more of the one or more base components, and maximizing the surgical working space around the base of the ultrasonic transducer.

20. A system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising a cable connected to the ultrasonic transducer, wherein the cable is oriented with respect to the ultrasonic transducer and one or more of the one or more base components, such that the ultrasonic transducer-cable interface and the body of the ultrasonic transducer form an angle of about 30 to about 90 degrees.

21. A system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising a cable connected to the ultrasonic transducer, wherein the cable is oriented with respect to the ultrasonic transducer and one or more of the one or more base components, such that the ultrasonic transducer-cable interface is centered or off-center along the front or rear of the body of the ultrasonic transducer.

22. A system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising a cable connected to the ultrasonic transducer, wherein the cable is oriented with respect to the ultrasonic transducer and one or more of the one or more base components, such that the ultrasonic transducer-cable interface is centered or off-center along one or more sides of the body of the ultrasonic transducer.

23. A system for attaching an ultrasonic transducer to a patient according to claim 1, further comprising one or more sensors for measuring the absolute or relative orientation of the ultrasonic transducer with respect to at least one of the one or more base components, the one or more fixing components, and the patient's anatomical structure.

24. A system for attaching an ultrasonic transducer to a patient according to 23, characterized in that at least one of the one or more sensors is installed within the housing of the ultrasonic transducer, and at least one of the one or more sensors is installed within at least one of the one or more base components and the one or more fixing components.

25. The system for attaching the ultrasonic transducer according to claim 1 to a patient is characterized in that the ultrasonic transducer is an ultrasound-based imaging dual-array probe comprising two ultrasonic transducer arrays.

26. The ultrasonic transducer is an ultrasound-based imaging dual-array probe comprising two ultrasonic transducer arrays and a longitudinal slot, wherein the two ultrasonic transducer arrays are installed on opposite sides of the longitudinal slot, and the system for attaching the ultrasonic transducer to a patient is as described in claim 1.

27. The system for attaching the ultrasonic transducer to a patient, as described in claim 1, is characterized in that the orientation of the ultrasonic transducer and the two-dimensional ultrasonic image data are processed by a computer processor to form a volumetric three-dimensional ultrasonic dataset, thereby generating visualization of the patient's anatomical structures that are close to or adjacent to the patient's insertion cavity.

28. A system for attaching an ultrasonic transducer to a patient according to claim 27, characterized in that the computer processor uses the orientation of the ultrasonic transducer to associate the position of the two-dimensional ultrasonic scanning plane with respect to an anatomical reference criterion that includes at least one of a volume ultrasonic dataset of the patient's anatomical structures and a volume reference model.

29. A system for attaching the ultrasonic transducer according to claim 1 to a patient, wherein the ultrasonic transducer is an ultrasound-based imaging dual-array probe having a dual array positioned on the opposite side of a longitudinal slot, and the imaging generated by the longitudinal slot and the dual array provides an in-planar guide for inserting the needle, the probe, or the injectable device into the patient's insertion cavity at a desired anatomical position.

30. The system for attaching an ultrasonic transducer to a patient according to claim 1, characterized in that the one or more base components include one or more straps positioned around the patient's body.

31. The ultrasonic transducer is capable of receiving one or more straps, and the system for attaching the ultrasonic transducer to a patient is as described in 30.

32. The system for attaching the ultrasonic transducer according to claim 1 to a patient, characterized in that the one or more base components include a surgical drape or are integrated within a surgical drape.

Images