Hand-free fixing system of ultrasonic transducer

Abstract

A system for attaching an ultrasound scanning transducer to a body for medical treatment during a needle injection procedure provides hand-free image guidance of needle advancement and provides dimensional specifications compatible with a sterilization workflow that minimizes occlusion of field of view and maximizes needle insertion space. In embodiments, the present invention interfaces with an ultrasound probe to stabilize the probe on a patient's anatomy during real-time imaging, facilitate probe repositioning, and provide sufficient operating space around the probe for a doctor to plan and perform needle insertion.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application relies upon and claims the benefit of priority and filing date of U.S. Application No. 63 / 444,524, filed February 9, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Statement Regarding Federally Funded Research This invention was made with government support from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) under Grant No. R44NS120798.

[0003] The U.S. Government has certain rights in this invention. Technical Field

[0004] The present invention relates to a device that can be used to attach an ultrasound scanning transducer to the body for medical treatment during a needle injection procedure. Background Art

[0005] Needle guidance procedures in medicine are numerous and encompass diverse procedures, such as lumbar punctures, bone marrow biopsies, acute pain analgesia, and injections for chronic pain management. A wide range of techniques are available for injection guidance, ranging from palpation-based methods without any imaging guidance to methods guided by imaging modalities such as ultrasound, computed tomography, or fluoroscopy. Palpation methods are low-cost and can be performed at the bedside, but they are associated with low procedural success rates and high complication rates. Traditional ultrasound techniques can improve procedural success rates and are used in some cases, but they have limitations, including a long learning curve and the need to simultaneously operate the ultrasound probe and insert the needle (the latter often requiring two-handed surgery). X-ray-based methods such as computed tomography or fluoroscopy, while offering higher success rates, expose the patient to ionizing radiation and increase procedural costs. Furthermore, these methods are often not feasible at the bedside and are incompatible with workflow constraints in settings such as the emergency department.

[0006] In order to overcome the limitations of existing technical methods in the process of medical needle guidance, the present invention introduces a device that can be used to attach an ultrasound probe to a patient, thereby facilitating interventional needle guidance workflow. In various aspects, the device can be used as a disposable sterile consumable and support sterilization operations, can maintain hands-free imaging contact between the probe and the patient, while providing minimal obstruction to the field of view and needle insertion space related to the patient's anatomical structure related to the operation, so that the clinician can place and advance the needle with one hand or both hands. Compared with traditional ultrasound technology, this hands-free approach is an improvement, in which the clinician needs to hold the ultrasound imaging transducer with one hand and advance the needle with the other hand, or requires an assistant to assist in completing part of the operation so that the doctor can free up both hands to advance the needle. Various preferred embodiments of the present invention are described herein. Summary of the Invention

[0007] The exemplary embodiments described herein have innovative features, but no single feature thereof is indispensable, nor is it the sole determinant of its superior properties. The following description and accompanying drawings set forth in detail certain illustrative embodiments of the present disclosure, which indicate several exemplary ways in which the various principles of the present disclosure may be implemented. However, these exemplary examples are not exhaustive of all possible embodiments of the present disclosure. Without limiting the scope of the claims, some of the beneficial features are summarized below. Other objects, advantages, and novel features of the present disclosure will be set forth in the detailed description of the present disclosure below in conjunction with the accompanying drawings, which are intended to illustrate, not to limit, the present invention.

[0008] In embodiments, the present invention provides hands-free image guidance for needle advancement and a form factor compatible with sterile workflows that minimizes obstruction of the field of view and maximizes needle insertion space. In embodiments, the present invention interfaces with an ultrasound probe to stabilize the probe on the patient's anatomy during real-time imaging, facilitate probe repositioning, and provide ample maneuvering space around the probe for the physician to plan and execute needle insertion. Additionally, in various aspects, the device supports optional attachment of components to the ultrasound probe to guide needle trajectory. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings illustrate specific aspects of some embodiments of the present invention and should not be used to limit or define the present invention. The drawings, together with the written description, serve to illustrate certain principles of the present invention. For a more complete understanding of the nature and advantages of the present technology, please refer to the following detailed description of the preferred embodiments in conjunction with the accompanying drawings, in which: Figures 1A-1C is a schematic diagram of an exemplary device attached to a patient's anatomy and an exemplary ultrasound probe incorporated into the device.

[0010] Figure 2The device is depicted in an exemplary application along with an exemplary ultrasound probe attached to a patient's anatomy.

[0011] Figure 3 A flow chart is depicted showing a clinician using the device of the present invention to assist in performing a needle guidance procedure.

[0012] Figures 4A-4C is a schematic diagram of an exemplary device with a rotating component and an exemplary dual-array probe docked with the device.

[0013] Figures 5A-5D Schematic diagrams of an exemplary device attached to a patient's anatomy and an exemplary ultrasound probe incorporated into the device. The schematic diagrams show a device consisting of two base components integrated into a sterile patient drape with an elastic band on the drape securing the ultrasound probe between the two base components.

[0014] Figures 6A-6D is a schematic diagram of an exemplary device in which the angle is set by the configuration of a fixing component that interfaces with the ultrasound probe.

[0015] Figures 7A-7B is a schematic diagram of an exemplary securing component including an acoustically transmissive material, an acoustic coupling distribution component, and / or an acoustically transmissive adhesive component. The securing component can be integrated with other securing components (possibly including elastic bands) and a sterile probe drape or cover.

[0016] Figure 8 An exploded view of an exemplary dual array probe with a U-shaped slot and needle guide insert is shown.

[0017] Figure 9 An exemplary dual-array probe is shown coupled to an exemplary software platform and a medical cart.

[0018] Figure 10 A flow chart depicts a clinician performing a needle guidance procedure using the device of the present invention with the assistance of an exemplary dual array probe with position tracking. DETAILED DESCRIPTION

[0019] Ultrasound imaging transducer assemblies are used in a variety of medical or clinical applications to perform medical imaging functions. In this non-limiting example, an ultrasound imaging transducer is disposed within the transducer assembly to transmit pulsed, audio, sequenced, or programmed energy signals to the target location to be imaged. A specific example is one or more ultrasound transducer elements that transmit ultrasound signals into the patient's body and detect return signals to form a computer-generated image of the target area. Depending on the specific application and design, as known to those skilled in the art, different ultrasound imaging modalities can be employed. The present disclosure can be used in, but is not limited to, medical ultrasound applications. Those skilled in the art will appreciate that various types of transducers, signal transmitters and / or receivers, and other arrays can also benefit from the present disclosure and are encompassed by the present disclosure. Preferred embodiments herein describe needle guidance. Those skilled in the art will appreciate that the present disclosure can be used to guide a variety of medical devices, including, but not limited to, catheters, trocars, ablation devices, or therapeutic applicators. In preferred embodiments, the present disclosure 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, guidance, and visualization of ultrasound-based therapy guidance procedures.

[0020] In embodiments of the present invention described herein for medical needle guidance applications, one objective of the device is to stabilize an ultrasound probe on the patient's anatomy, enabling the physician to remove their hands from the device while maintaining acoustic coupling for image guidance of needle insertion. In embodiments, additional objectives include minimizing visual obstruction of underlying anatomical structures relevant to the medical procedure, minimizing operational obstruction of the needle insertion point, simplifying (in some respects) repositioning and orientation of the ultrasound probe, and compatibility with sterilization workflows. In embodiments, the present invention comprises one or more base components that can be removably attached to the patient near or adjacent to the patient's anatomy relevant to the medical procedure. The base components can comprise rigid, semi-rigid, or substantially rigid materials such as plastic or metal and provide anchor points to secure the ultrasound transducer in contact with the patient's anatomy. In embodiments, the present invention comprises one or more securing components that can be attached to the one or more base components and the ultrasound transducer and provide a directional force to maintain contact between the ultrasound transducer and the patient's anatomy. The one or more securing components can comprise a flexible or substantially flexible material such as rubber, certain plastics, or fabric, or can comprise a rigid, semi-rigid, or substantially rigid material such as plastic or metal. In an embodiment, the present invention provides a mechanism for adjusting the position of an ultrasound transducer attached to a patient's anatomy by a device, the mechanism can comprise an arrangement of one or more base components and one or more securing components designed to enable a user to manually reposition the ultrasound probe within the device, such as by applying force to the ultrasound probe handle, the one or more securing components, or the one or more base components.

[0021] In an exemplary embodiment, the device Figure 1A . The device has a base component 100 that attaches to the patient's anatomy. Non-limiting examples of methods of attaching the base component 100 to the patient's anatomy include incorporating an adhesive layer on the patient contacting side, incorporating a strip around the patient's anatomy, a suction mechanism, a magnetic mechanism, or other methods of fixing the position of 100 on the patient's anatomy. In this non-limiting example, the base component is depicted as having a rectangular shape with rounded corners, but other shapes can be envisioned. The design can be a configuration that conforms to the specific patient's anatomy and provides visual operating space and needle insertion space, including but not limited to circular or semi-circular shapes. Fiducial markers 101 can provide measurements to the user for planning surgery and probe positioning. In various aspects, component 102 can be used to attach a rubber band 103 or strip along the perimeter of the device that secures the ultrasound probe within the device.

[0022] exist Figure 1BIn the non-limiting embodiment shown, the device 100 can be adapted to conform to a sterile workflow, wherein the device is applied to a sterile portion of a patient's anatomy 104 and can be draped for imaging exploration and needle insertion, while a sterile drape 105 (e.g., a surgical drape) covering the non-sterile patient anatomy is bonded to or incorporated into the outer edge of the device 100. In an embodiment, the drape can be of the same size and material used during epidural and spinal anesthesia or other similar needle-guided procedures.

[0023] exist Figure 1C In the non-limiting embodiment shown, the ultrasound probe 106 and ultrasound cable 107 can be integrated into the device and can be retained within the securing band 103 by a positioning guide 108 that limits lateral movement. The positioning guide 108 can be directly incorporated into the ultrasound probe 106, or in other non-limiting embodiments can be comprised of a sterilizable component that is clipped onto the ultrasound probe housing. In a non-limiting embodiment, the ultrasound signal cable 107 connects the ultrasound probe 106 to a computer processor, with alternative embodiments including wireless signal transmission or incorporating the computer processor and display directly into the probe housing.

[0024] exist Figure 2 A schematic diagram of a procedure involving a patient's spinal anatomy is depicted in FIG. In this non-limiting embodiment, the underside of the device 100 includes a medical-grade adhesive designed to secure the base component of the device to the patient's skin, centered over the area where the needle will be inserted. After probing the sterilized anatomy with the ultrasound probe 106, the physician leaves the ultrasound probe in place and uses one or both hands to insert the needle into the "window" provided by the device 100.

[0025] exist Figure 3 A flow chart of one embodiment of the present invention for clinical needle guidance procedures is depicted in FIG. At box 301, the user first sterilizes the patient's anatomy surrounding the intended injection site. At box 302, the user places the sterile drape component 105 of the device over the non-sterile patient's anatomy, leaving an open window over the sterilized anatomy. The base component of the device 100 is then attached to the patient's anatomy via an adhesive layer incorporated into the component. At box 303, as Figure 2As shown, the ultrasound probe is integrated into the device in the desired imaging position and coupled to the patient's body using ultrasound coupling gel or other lubricants known to those skilled in the art and compatible with medical ultrasound. Next, at block 304, the user initiates image acquisition. At block 305, the ultrasound image acquisition is transmitted to the computer system, and the reconstructed image is displayed in real time on the monitor. At block 306, the user can manually translate the ultrasound probe 106 within the device until the desired anatomical structure is within the imaging plane. At block 307, the user removes their hand from the ultrasound probe 106, securing the probe within the device 100 while continuing to display the real-time anatomical image. At block 308, the user uses one or both hands to insert the needle and monitor the needle's trajectory into the real-time imaging display. At block 309, if the real-time imaging display indicates that the needle is no longer in view, the user can reposition the ultrasound probe 106 within the device 100 to regain visualization of the needle. At block 310, the user completes the procedure by advancing the needle to the target site, as confirmed by the real-time imaging display.

[0026] exist Figure 4A In the illustrated non-limiting embodiment, a unique split-array ultrasound probe 400 is integrated into the previously described device 100 or otherwise attached or connected to the device. The unique split-array ultrasound probe 400 includes a U-shaped slot 402 for facilitating in-plane needle insertion (related information of which can be found in U.S. patent application Ser. No. 17 / 950,399, incorporated herein by reference). The device is retained within the securing strap 103 by a positioning guide 403 that restricts lateral movement. The positioning guide 403 can be incorporated directly into the ultrasound probe 400 or, in other non-limiting embodiments, can comprise a sterilizable component that clips onto the ultrasound probe housing. In this non-limiting embodiment, an ultrasound signal cable 401 connects the ultrasound probe 400 to a computer processor, but alternative embodiments can include wireless signal transmission or incorporate the computer processor and display directly into the probe housing. In a non-limiting embodiment, 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 vertical profile of the ultrasound probe relative to the patient's anatomy, improve stability within the device, and / or maximize the surgical operating space around the base of the ultrasound probe 400. Non-limiting examples include a probe-cable interface at an angle between 30 and 90 degrees to the probe body, a probe-cable interface with angular adjustment centered or off-center along the front or back of the ultrasound probe body, and a probe-cable interface with angular adjustment centered or off-center along either side of the probe body.

[0027] In a preferred embodiment, Figure 4BA device is depicted in . In this non-limiting example, the base component is circular, but can be designed to conform to specific patient anatomy and provide other configurations of visual manipulation space and needle insertion space. The second component 404 provides a rotation ring by which the internal components of the device can be rotated to reposition the ultrasound probe while the base component 100 remains fixed to the patient. Fiducial markers 405 and 406 provide an indication of the degree of rotation to the user. In a non-limiting embodiment, a position tracking clip 407 that secures the ultrasound probe within the device is attached to component 102 on the base device. In a non-limiting embodiment, the position tracking clip 407 contains electronic components that can determine the position of the probe within the clip. Fiducial marker 408 can provide an indication of the position along the position tracking clip 407. In Figure 4C 4 shows an ultrasound probe 400 incorporated into the device. The ultrasound probe 400 can incorporate a sensor that reads the probe's position within a position-tracking clip 407 and transmits these signals to an imaging system via an ultrasound probe cable 401. In preferred embodiments, position measurement is achieved using magnetic / inductive or resistive methods. In one such embodiment, the passive, non-self-powered elements of the sensor system are incorporated into the position-tracking clip 407, while the actively powered sensor is incorporated into the ultrasound probe 400. In a non-limiting embodiment, a needle guide 409, supplied with the device, is inserted into the U-shaped slot 402 of the ultrasound probe 400 to guide the needle trajectory within the device and facilitate in-plane needle delivery during surgery.

[0028] In an exemplary embodiment, Figure 5A A device is depicted in FIG. The device has two base components 500 and 502 that attach to a patient drape 504. Non-limiting examples of methods for attaching the base components 500 and 502 to the patient drape include incorporating an adhesive layer on the patient contacting 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 conforms to the top and bottom positions of the patient drape opening 506, but other shapes and positions along the patient drape opening 506 can be envisioned. The design can be a configuration that conforms to the specific patient anatomy and provides visual manipulation space and needle insertion space, including but not limited to a circular or semi-circular shape. A securing component 508 can be used to secure an elastic band 510, a strap, or other flexible material that connects the two base components 500 and 502 to the patient drape opening 506 for securing the ultrasound transducer.

[0029] exist Figure 5BIn the non-limiting embodiment shown, the ultrasound probe 512 and ultrasound signal cable 514 can be integrated into the device and can be retained within the securing band 510 by a positioning guide 516 that limits lateral movement. The positioning guide 516 can be directly incorporated into the ultrasound probe 512, or in other non-limiting embodiments can be comprised of a sterilized component that is clipped onto the ultrasound probe housing, or can be comprised of a sterilized component that is attached to an ultrasound probe sheath that can be attached to the ultrasound probe housing. In a non-limiting embodiment, the ultrasound signal cable 514 connects the ultrasound probe 512 to a computer processor, with alternative embodiments including wireless signal transmission or integrating the computer processor and display directly into the probe housing.

[0030] exist Figure 5C In the non-limiting embodiment shown, the base components 500 and 502 are capable of complying with a sterile workflow wherein they are applied to a sterile portion of a patient anatomy 506 and can be covered for imaging exploration and needle insertion, while a sterile drape 504 (e.g., a surgical drape) covering a non-sterile patient anatomy is incorporated with or into the base components 500 and 502.

[0031] In an embodiment, the drape can be of the same size and material used during epidural and spinal anesthesia or other similar needle-guided procedures. Attachment members 518 and 520 are incorporated into the patient drape to secure the drape 504 to the patient's anatomy. Non-limiting examples of attachment members 518 and 520 include adhesive layers, straps, suction mechanisms, magnetic mechanisms, or other methods of securing the patient drape 504 to the patient's anatomy.

[0032] exist Figure 5D In the non-limiting embodiment shown, the base members 500 and 502 are attached to the patient drape 504 using attachment members 522 and 524, while the patient drape 504 is attached to the patient's anatomy using attachment members 518 and 520. Non-limiting examples of attachment members 522 and 524 include adhesive layers, straps, suction mechanisms, magnetic mechanisms, or other methods of securing the patient drape 504 to the patient's anatomy.

[0033] exist Figure 6A In the non-limiting embodiment shown, a unique split array ultrasound probe 512 with notches for in-plane needle insertion (related content can be found in U.S. Patent Application No. 17 / 950,399) is secured within the device by an elastic band 510 and configured, for example by manual operation, to maintain a certain angle so that the needle 600 can penetrate the patient's anatomical structure 602 at a flat angle. Figure 6BIn the embodiment, the angle of the ultrasound probe 512 in the positioning device 516 can be readjusted (such as by manual operation) so that the needle 600 can penetrate the patient's anatomical structure 602 at a certain angle. Non-limiting examples include a Figure 6A The straight angle shown relative to the entry allows the needle to be angled to form an angle between 0 and 20 degrees. Figure 6C Depicted in Figure 6A A front view of the contents shown, wherein the needle 600 is placed in the U-shaped groove 604 for in-plane needle insertion. Figure 6D Depicted in Figure 6B A front view of what is shown, in which the needle angle has been adjusted by user manipulation, and the securing component 510 and positioning component 516 stabilize the ultrasound probe against the patient anatomy 602.

[0034] exist Figure 7A A component level view of an exemplary fixed component designed as a dual array housing 700 is depicted in FIG. Figure 7BA component-level exploded view of an exemplary dual-array housing 700 is depicted in FIG. The imaging device can include dual ultrasound arrays 702 and associated electromechanical components familiar to those skilled in the art, enclosed in a mechanical housing. The imaging device can include an acoustic lens 704 and an acoustic coupler 706, which can be separate components or integrated with other mechanical housings to optimize the transmission of acoustic energy from the arrays 702. In a non-limiting embodiment, the lens 704 and acoustic coupler 706 can comprise disposable, sterilizable components that can be used to provide a sterilization barrier between the ultrasound arrays 702 and the patient's anatomy. Additional ultrasound arrays, matrix transducer arrays, or capacitive micromachined ultrasound transducer (C-MUT) arrays can be used in place of the two ultrasound arrays 702 to improve the field of view or image acquisition speed. A disposable, sterilizable assembly 708 can enclose the array 702, acoustic coupler 706, and lens 704 assembly. In a non-limiting embodiment, the probe housing can include a disposable sterile component that can be used to apply a sterile barrier between the ultrasound array 702 and the patient's anatomy. In a non-limiting embodiment, the disposable sterile assembly 708 can be acoustically coupled to the lens 704 using an acoustic coupling component 710, which can include an adhesive film, an aqueous material such as ultrasound gel, oil, or a sponge designed to retain and distribute aqueous materials or oils. In a non-limiting embodiment, the probe housing 708 can include a securing component that is attached to a sterile probe drape, such as by an adhesive material incorporated into the disposable sterile assembly 708. In a non-limiting embodiment, the disposable sterile assembly 708 can include a securing component 712 that is designed to secure the dual array housing 700 within the disposable sterile assembly 708. In various aspects, 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 sterilization assembly 708 can include an acoustic coupling component 714 that provides an acoustic transmission medium between the disposable sterilization assembly 708 and the patient's anatomy. The acoustic coupling component can include an adhesive film, an aqueous material such as an acoustic gel, an oil, or a sponge designed to retain and distribute an aqueous material or oil.

[0035] Figure 8A component-level exploded view of an exemplary dual-array ultrasound probe 400 is depicted. The imaging device can include dual ultrasound arrays 800 and associated electromechanical components familiar to those skilled in the art, enclosed in a mechanical housing. The ultrasound probe 400 electronics can incorporate position encoders whose signals are relayed via the ultrasound probe cable 401 to a computer processor to indicate linear position changes of the linear actuators, image acquisition from the ultrasound arrays 800, and signal or image processing steps applied to the acquired ultrasound image signals. The imaging device can include an acoustic lens and acoustic coupler 801, which can be discrete components or integrated with other mechanical housings, for optimizing the transmission of acoustic energy from the arrays 800. In a non-limiting embodiment, the lens and acoustic coupler 801 can comprise disposable, sterilizable components that can be used to apply a sterilization barrier between the ultrasound probe 400 and the patient. Additional ultrasound arrays, matrix transducer arrays, or C-MUT arrays can be used in place of the two ultrasound arrays 800 to improve the field of view or image acquisition speed. In various aspects, a disposable needle guide 409 is inserted into the probe housing to provide a sterile or non-sterile needle trajectory guide. The needle guide 409 can constrain the needle to a position at the base of the U-shaped slot 402 so that the needle is accurately placed in the desired anatomical position and within the ultrasound imaging plane. The needle guide 409 can allow the needle to be removed from the anatomical structure and imaging device 400 through the length of the U-shaped slot 402. The needle guide 409 can be configured to constrain or allow removal of the needle through a mechanism including, but not limited to, rotating, opening, or removing the needle guide. The entire ultrasound probe assembly can be covered by a sterilization sheath before being incorporated into a stabilization device to support sterile procedures.

[0036] exist Figure 9In the exemplary embodiment shown, the ultrasound probe 400 can be connected to a mobile cart 900 via an electrical signal cable 401, allowing the imaging device to be moved to the bedside and positioned in a desired or ideal orientation for acquiring images of the patient's anatomy. The cart 900 can include a housing 901, which can contain a computer processor and monitor 902, a battery 903, and other associated electronics familiar to those skilled in the art for powering and communicating with the imaging device 400. The cart 900 can be equipped with additional input / output devices such as a keyboard, mouse, or monitor 902, or a touchscreen display. The monitor 902 can be adjusted around the cart to position the imaging device 400 and monitor in various relative positions for needle-guided procedures. In a preferred embodiment, the housing 901 can simultaneously contain the monitor 902, the computer processor, and the ultrasound front-end electronics. The computer processor within the housing 901 can be used to perform the image processing steps required to reconstruct the ultrasound signal and form an ultrasound image that can be displayed on the monitor 602. Such processing steps are known to those skilled in the art of medical ultrasound and can include, but are not limited to, beamforming, bandpass filtering, scan conversion, and image rendering. Various techniques can be used to render two-dimensional and three-dimensional images, as described in U.S. Patent No. 11,504,095 to Mauldin et al. (incorporated herein by reference), including simultaneous display. In a preferred embodiment, a computer processor in the housing 601 can receive a signal from the ultrasound probe 400 indicating the position of the probe within the apparatus, which can be used to interpret the spatial position of the acquired real-time image data. In a preferred embodiment, calibration of the spatial position of the imaging data can be used to reconstruct a three-dimensional ultrasound image that is functionally equivalent to a fluoroscopic image of the bony anatomy.

[0037] exist Figure 10 A flow chart of an exemplary embodiment of the present invention for clinical needle-guided surgery is depicted in . At box 1001, the user first attaches the device base component 100 to the patient at the desired needle insertion position. At box 1002, as shown in FIG4 , the ultrasound probe is integrated into the device at the desired imaging position and coupled to the patient's body using ultrasound coupling gel or other lubricants compatible with medical ultrasound that are well known to those skilled in the art. Next, at box 1003, image acquisition is initiated by the user. The initiation can be achieved through the monitor 902, a user interface button, or other means known to those skilled in the art. At box 1004, the ultrasound image acquisition is transmitted to the computer system within the envelope 901, and the reconstructed image is displayed on the monitor 902. Figure 4CIn the illustrated embodiment, the ultrasound probe 400 is contained within a position-tracking clip 407, allowing the user to manually translate the probe along the clip to acquire three-dimensional images. In this same embodiment, at block 1005, the position of the ultrasound probe 400 is calibrated during image acquisition to construct a three-dimensional image volume. At block 1006, the real-time image is aligned with a representation of other imaged anatomy for the procedure, derived from three-dimensional ultrasound data or other representations of the anatomy, such as the ideal imaged anatomy for the procedure. At block 1007, a determination is made as to whether the current image meets criteria indicating alignment of the needle guide with the needle injection target. This assessment can be automatically generated by a processing algorithm running on a computer system, such as that described in U.S. Patent No. 11,504,095 to Mauldin et al. (incorporated herein by reference), or can be performed by the user through visual assessment of rendered imaging results. If these criteria are not met, block 1008 directs the user to adjust the position of the ultrasound probe 400 to provide better alignment with the target anatomy, providing guidance to address challenges that may be encountered while performing the procedure. If the criteria are met, block 1009 directs the user to proceed with needle placement. In various aspects, user initiation of needle guidance mode 1010 causes the software to transition to an imaging mode that enhances real-time visualization of the needle during insertion 1011. Finally, at block 1012, the user advances the needle through the needle guide 409 and is visualized in an ultrasound image rendering displayed on the monitor 901 as the needle advances toward the needle target.

[0038] Embodiments of the present invention also include computer-readable media comprising one or more computer files containing a set of computer-executable instructions for performing one or more of the calculations, steps, processes, and operations described and / or depicted herein. In exemplary embodiments, the files may be stored on the computer-readable medium in a continuous or discontinuous manner. Embodiments may include a computer program product comprising the computer files, or in the form of a computer-readable medium containing the computer files, and optionally made available to consumers through packaging or electronic distribution. As used in the context of this specification, "computer-readable medium" is non-transitory 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 memories (EEPROMs), and RAM. In exemplary embodiments, the computer-readable medium has stored thereon a set of instructions that, when executed by a processor, cause the processor to perform tasks based on data stored in an electronic database or memory described herein. The processor may implement this process using any of the programs discussed in this disclosure or any equivalent program.

[0039] In other embodiments of the present invention, the file comprising the computer executable instruction set may be stored in a computer readable memory on a single computer or distributed across multiple computers. Those skilled in the art will further appreciate from this disclosure that, in addition to software, hardware or firmware may be used to implement the present invention. Therefore, as used herein, the operations of the present invention can be implemented in a system comprising a combination of software, hardware, or firmware.

[0040] Embodiments of the present disclosure include one or more computers or devices loaded with a set of computer-executable instructions described herein. The computer or device can be a general-purpose computer, a special-purpose computer, or other programmable data processing device to produce a specific machine, so that one or more computers or devices are instructed and configured to perform the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or calculation routines of the present disclosure. The computer or device that performs the specified calculations, processes, steps, operations, algorithms, statistical methods, formulas, or calculation routines of the present disclosure may include at least one processing element, such as a central processing unit (i.e., a processor) and a computer-readable memory that may include random access memory (RAM) or read-only memory (ROM). The computer-executable instructions can be embedded in computer hardware or stored in a computer-readable memory so that the computer or device can be directed to perform one or more of the calculations, steps, processes, and operations depicted and / or described herein.

[0041] Additional embodiments of the present disclosure include computer systems for performing the computer-implemented methods 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 methods. The computer system can include a standalone computer such as a desktop computer, a portable computer such as a tablet computer, a laptop computer, a PDA, or a smartphone, or a group of computers connected via a network including a client-server configuration and one or more database servers. The network can use any suitable network protocol, including IP, UDP, or ICMP, and can be any suitable wired or wireless network, including any local area network, wide area network, internet network, telecommunications network, Wi-Fi-enabled network, or Bluetooth-enabled network. In one embodiment, the computer system includes a central computer connected to the internet, the central computer having computer-executable instructions stored in memory, the memory operatively connected to an internal electronic database. The central computer can perform the computer-implemented methods based on input and commands received from remote computers via the internet. The central computer may effectively act as a server and the remote computers may act as client computers such that a server-client relationship is established and the client computers issue queries or receive output from the server over the network.

[0042] The input / output interface may include a graphical user interface (GUI) that can be used in conjunction with the computer-executable code and the electronic database. The graphical user interface may allow a user to perform these tasks by using text fields, checkboxes, drop-down menus, command buttons, and the like. 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 may optionally be accessed via a computer connected to the Internet. In one embodiment, the user interface may be accessed by entering an Internet address and accessing a web page via an industry-standard web browser. The user interface may then be operated by a remote computer (client computer) accessing the web page and sending queries or receiving output from the server via the network connection.

[0043] The present invention has been described with reference to specific embodiments having various features. It will be apparent to those skilled in the art from the disclosure provided above that various modifications and variations can be made in the practice of the present invention without departing from the scope or spirit of the invention. Those skilled in the art will recognize that, based on the requirements and specifications of a given application or design, the disclosed features may be used individually, in any combination, or omitted. When an embodiment refers to "comprising" certain features, it will be understood that the embodiment may alternatively "consist of" or "consist essentially of any one or more features." Other embodiments of the present invention will be apparent to those skilled in the art by consideration of the specification and practice of the present invention.

[0044] Note that, when a range of values ​​is provided in this specification, each value between the upper and lower limits of the range is also specifically disclosed. The upper and lower limits of these smaller ranges may also be independently included or excluded within the scope. The singular forms "a", "an" and "the" include plural indicators unless the context clearly indicates otherwise. The description and examples are to be considered exemplary in nature, and variations that do not depart from the essence of the present invention fall within the scope of the present invention. In addition, all references cited in this disclosure are each incorporated herein by reference in their entirety, and are therefore intended to provide effective ways to supplement the disclosure of the present invention and to provide a background detailing the level of those of ordinary skill in the art.

[0045] As used herein, the term "about" refers to plus or minus 5 units (eg, percentages) of the stated value.

[0046] Reference in the specification to "some embodiments," "an embodiment," "one embodiment," or "other embodiments" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least some, but not necessarily all, embodiments of the invention.

[0047] As used herein, the terms "substantially" and "substantially" refer to what one of ordinary skill in the art would readily recognize.

[0048] It is to be understood that the phraseology and terminology employed herein should not be interpreted as limiting and are for description purpose only.

[0049] It should be understood that while some illustrations and figures may be close to exact scale, most illustrations and figures are not intended to be true to scale.

[0050] It will be understood that the details set forth herein are not to be construed as limitations on the application of the invention.

[0051] Furthermore, it is to be understood that the invention is capable of being carried out or practiced in various ways and that the invention can be implemented in embodiments other than those outlined in the description above.

Claims

1. A system for attaching an ultrasound transducer to a patient, the system comprising: one or more base components removably attachable to the patient proximate or adjacent to the patient's anatomy; as well as one or more securing members that interface with the ultrasound transducer and the one or more base members to (a) attach the ultrasound transducer to the one or more base members near or adjacent the patient anatomy and (b) substantially maintain acoustic coupling between the ultrasound transducer and the patient anatomy; The system allows a user to operate within a range of about 10% to about 95% of a patient's anatomy that is proximal or adjacent to the ultrasound transducer to insert a needle, probe, or injectable device.

2. The system for attaching an ultrasonic transducer to a patient according to claim 1 further comprises a mechanism for adjusting the position of the ultrasonic transducer, wherein the mechanism enables the ultrasonic transducer to move at least one of up and down, left and right, diagonally along the patient contact surface, and at a certain angle relative to the patient contact surface.

3. The system for attaching an ultrasound transducer to a patient according to claim 2, wherein: The mechanism for adjusting the position of the ultrasound transducer enables adjustment of the angle of the ultrasound transducer relative to the patient anatomy.

4. The system for attaching an ultrasound transducer to a patient according to claim 2, wherein: The mechanism for adjusting the position of the ultrasound transducer includes a member operable by a user to substantially maintain, or alternatively set, the angle of the ultrasound transducer relative to the patient anatomy.

5. The system for attaching an ultrasound transducer to a patient according to claim 1 , wherein: The one or more securing components include one or more of a strap, a clip, a track, an adhesive, or a housing.

6. The system for attaching an ultrasound transducer to a patient according to claim 5, wherein: The track comprises at least two elongated members extending between two base members of the one or more base members, wherein the at least two elongated members are positioned substantially parallel to each other, and wherein the at least two elongated members are attached to the ultrasonic transducer and enable the ultrasonic transducer to slide along the track between the two base members of the one or more base members.

7. The system for attaching an ultrasound transducer to a patient according to claim 1 , wherein: The one or more securing components include an acoustic transmission member between (a) the ultrasound transducer or probe sheath and (b) a patient contacting surface.

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

9. The system for attaching an ultrasound transducer to a patient according to claim 1 , wherein: The one or more fixation components are physically integrated with the probe sheath or drape.

10. The system for attaching an ultrasound transducer to a patient according to claim 9, wherein: The probe cover or the drape fully or partially covers the ultrasound transducer to substantially maintain a sterile field.

11. The system for attaching an ultrasound transducer to a patient according to claim 1 , wherein: The one or more fixation components include an acoustic transmission component between the ultrasound transducer and a probe sheath or drape.

12. The system for attaching an ultrasound transducer to a patient according to claim 1, wherein: The one or more fixing components include an acoustic coupling distribution component.

13. The system for attaching an ultrasound transducer to a patient according to claim 12, wherein: The acoustic coupling dispensing component includes one or more of an absorbent pad, a sponge, or an encapsulated reservoir, and wherein the acoustic coupling dispensing component dispenses an acoustic coupling fluid to substantially maintain acoustic contact between the ultrasound transducer and the patient anatomy.

14. The system for attaching an ultrasound transducer to a patient according to claim 12, wherein: The acoustic coupling distribution member is fully or partially saturated with water, saline, povidone iodine or acoustic gel.

15. The system for attaching an ultrasound transducer to a patient according to claim 12, wherein: The acoustic dispensing component applies an acoustic coupling fluid along an outer surface of the probe sheath to substantially maintain acoustic contact between the probe sheath and the patient anatomy.

16. The system for attaching an ultrasound transducer to a patient according to claim 12, wherein: The acoustic distribution component applies an acoustic coupling fluid along an inner surface of the probe sheath to substantially maintain acoustic contact between the ultrasound transducer and the probe sheath.

17. The system for attaching an ultrasound transducer to a patient of claim 1, 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, the opening or the slot substantially aligns or guides percutaneous injection of the needle, the probe or the injectable device.

18. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The one or more base components also include or are attached to a drape for covering all or a portion of the patient's body near or adjacent to the location where the needle, the probe, or the injectable device is to be inserted into the patient's body.

19. The system for attaching an ultrasound transducer to a patient of claim 1 , further comprising a cable connected to the ultrasound transducer, wherein The cable is oriented relative to the ultrasonic transducer and one or more of the one or more base components to at least one of: minimize the vertical profile of the ultrasonic transducer relative to the patient anatomy, stabilize the ultrasonic transducer and one or more of the one or more base components, and maximize the surgical operating space around the ultrasonic transducer base.

20. The system for attaching an ultrasound transducer to a patient of claim 1 , further comprising a cable connected to the ultrasound transducer, wherein The cable is oriented relative to the ultrasonic transducer and one or more of the one or more base components such that the ultrasonic transducer-cable interface is angled between about 30 degrees and about 90 degrees with the body of the ultrasonic transducer.

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

22. The system for attaching an ultrasound transducer to a patient of claim 1 , further comprising a cable connected to the ultrasound transducer, wherein The cable is oriented relative 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-centered along one or more sides of the body of the ultrasonic transducer.

23. The system for attaching an ultrasound transducer to a patient of claim 1 , further comprising one or more sensors for measuring an absolute or relative orientation of the ultrasound transducer relative to at least one of the one or more base members, the one or more fixation members, or the patient anatomy.

24. The system for attaching an ultrasound transducer to a patient according to claim 23, wherein: At least one of the one or more sensors is disposed within a housing of the ultrasound transducer, and wherein at least one of the one or more sensors is disposed within at least one of the one or more base components or the one or more fixed components.

25. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays.

26. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays and a longitudinal slot, the two ultrasound transducer arrays being disposed on opposite sides of the longitudinal slot.

27. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The ultrasound transducer orientation and the two-dimensional ultrasound image data are processed by a computer processor to form a volumetric three-dimensional ultrasound data set to generate a visualization of the patient's anatomical structures proximate or adjacent to the patient's insertion lumen.

28. A system for attaching an ultrasound transducer to a patient according to claim 27, wherein: The computer processor uses the orientation of the ultrasound transducer to associate with the user a position of a two-dimensional ultrasound scan plane relative to an anatomical reference standard comprising at least one of a volumetric ultrasound dataset or a volumetric reference model of the patient anatomy.

29. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The ultrasound transducer is an ultrasound-based imaging dual array probe having dual arrays arranged on opposite sides of a longitudinal slot, and wherein the longitudinal slot and the imaging generated by the dual arrays provide in-plane guidance for inserting the needle, the probe, or the injectable device into the patient's insertion cavity at a desired anatomical location.

30. The system for attaching an ultrasound transducer to a patient of claim 1, wherein: The one or more base components include one or more straps that are positioned about the patient's body.

31. A system for attaching an ultrasound transducer to a patient according to claim 30, wherein: The ultrasound transducer is capable of receiving the one or more strips.

32. The system for attaching an ultrasound transducer to a patient of claim 1 , wherein: The one or more base components comprise or are integrated into a surgical drape.

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