Systems and methods for needle guidance

Abstract

A needle guidance system includes a patient imaging system, such as an ultrasound guidance system (UGS) combined with a needle tip location system (TLS). The UGS defines a needle pathway to access an epidural / spinal space and overlays the pathway onto a live or frozen ultrasound image. The TLS magnetically determines a magnetic distal tip location of the needle including a depth with respect to a magnetic field sensor placed on the patient. A distal tip image overlayed atop the ultrasound image at a determined distal tip location. The UGS identifies the epidural / spinal space including a depth thereof within the ultrasound image. The UGS determines that the distal tip is located within the epidural / spinal space when the depth of the distal tip equals the depth of the epidural / spinal space. A probe securing apparatus secures an ultrasound probe of the UGS to the patient.

Description

SYSTEMS AND METHODS FOR NEEDLE GUIDANCEPRIORITY

[0001] This application claims priority to U.S. Provisional Application No. 63 / 626,417, filed lanuary 29, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Regional anesthesia is the use of local anesthetics to block sensations of pain from a large area of the body, such as an arm, a leg or the abdomen. Regional anesthesia allows a procedure to be done on a region of the body without requiring the patient to be unconscious. Examples of regional anesthesia include nerve blocks, spinal or epidural regional anesthesia. As an example of the process involved in the epidural / spinal process, it involves delivery of drug in the epidural / spinal space to achieve desired effect. Steps of the epidural / spinal process commonly include the following processes. The clinician may identify the desired interspace by surface anatomic landmarks and palpation or with ultrasonography. In some instances, a needle that is used to anesthetize the skin can also be used as a “finder needle” to help identify bony landmarks. With the desired interspace identified and a needle track defined, an epidural / spinal needle is inserted along the track toward the epidural / spinal space.

[0003] During insertion, the loss of resistance (LOR) technique is used to determine when the distal tip of the needle enters the epidural space. The LOR technique includes a syringe filled with air or saline that is coupled with the epidural needle, and a force is applied to the plunger of the syringe during insertion. The denser tissue between the skin surface and the epidural space defines a resistance to flow of the air or saline through the needle lumen. When the distal tip of the needle enters the epidural space, the air or saline flows more freely through the lumen defining a lower resistance to flow or the “loss of resistance.” Studies have shown that the LOR technical can be inadequate for some patients. The current placement procedure for accessing the epidural space has at least three major issues. The LOR technique is subjective and depends heavily on the experience of the Anesthetists. Variation in the LOR technique have caused mistakes during epidural space location resulting in issues such as Dural puncture. The identification of Iliac crest (insertion point) is commonly done using palpitation which can be very subjective. Accordingly, the lack of reliability of the current technique can result in increased costs, patient complications, and patient risk. Disclosed herein are systems and methods that address the forgoing.SUMMARY

[0004] Briefly summarized, embodiments of the disclosure are directed to a needle guidance system. Various guidance modalities can be used for the purpose such as, but not limited to, ultrasound and x-ray imaging techniques. As an example, it includes an ultrasound guidance system (UGS) and a tip location system (TLS) communicatively coupled with the UGS. The UGS includes an ultrasound probe having piezoelectric array configured for (i) producing ultrasonic pulses and (ii) receiving ultrasonic echoes thereof after reflection by anatomic elements within a target area of a patient. The UGS further includes a UGS console operatively coupled with the ultrasound probe, where the UGS console includes a UGS processor and UGS memory having UGS logic stored thereon that, when executed by the UGS processor, performs UGS operations that include processing echo data to determine an ultrasound image of the target area and depicting the ultrasound image on a display of the UGS.

[0005] The TLS includes a needle which is tracked in real time. To enhance the needle tracking sensitivity, different methods can be employed. One method is having a magnetic element disposed at a distal tip thereof, where the magnetic element is configured to define a magnetic field. The TLS further includes a TLS sensor configured for attachment to the patient at the target area, where the TLS sensor has a number of magnetic sensors configured to detect the magnetic field, and where in some embodiments, the needle includes a magnesite material. The TLS sensor further includes a TLS console coupled with the magnetic sensors, where the TLS console includes a TLS processor and TLS memory having TLS logic stored thereon that, when executed by the TLS processor, performs TLS operations that include processing magnetic field data to track a location of the distal tip with respect to the TLS sensor and communicating the location of the distal tip to the UGS. The UGS operations further include receiving the location of the distal tip from the TLS and overlaying a live distal tip image atop the ultrasound image in accordance with the location of the distal tip. In some embodiments, the TLS sensor is wirelessly coupled with the UGS console.

[0006] In some embodiments, the target area includes an epidural / spinal space of the patient and overlaying a live distal tip image includes depicting the distal tip image with respect to the epidural / spinal space in accordance with the location of the distal tip.

[0007] In some embodiments, the UGS operations further include freezing the ultrasound image and overlaying the live distal tip image atop the frozen ultrasound image.

[0008] In some embodiments, the TLS sensor includes an adhesive layer disposed along a bottom side of a housing of the TLS sensor, where the adhesive layer is configured to adhesively secure the TLS sensor to a skin surface of the patient.

[0009] In some embodiments, the UGS operations further include identifying the epidural / spinal space within the ultrasound image, and in some embodiments, the UGS operations further include determining a depth of the epidural / spinal space with respect to the skin surface and depicting the depth of the epidural / spinal space on the display. In some embodiments, the TLS operations further include determining a depth of the distal tip with respect to the bottom side of the TLS sensor (i.e., the skin surface) and the UGS operations further include depicting the depth of the distal tip on the display. In some embodiments, the UGS operations further include providing a notification to the clinician when the depth of the distal tip is equal to the depth of the epidural / spinal space within a defined tolerance stored in the UGS memory.

[0010] In some embodiments, the UGS operations further include (i) defining, from the ultrasound image, a needle pathway extending toward the epidural / spinal space and (ii) overlaying a needle pathway image atop the ultrasound image.

[0011] In some embodiments, the needle pathway extends to and intersects the skin surface within the frozen ultrasound image to define a UGS baseline location on the ultrasound image and the TLS operations further include recording the location of the distal tip when the distal tip is positioned at a needle insertion site on the skin surface of the patient to define a TLS baseline location. The TLS baseline is communicated to the UGS and the UGS operations further include digitally collocating the UGS baseline location and the TLS baseline location to correlate the ultrasound image to the location of the TLS sensor on the skin surface of the patient so that when the distal tip of the needle is positioned at the needle insertion site, the live distal tip image is depicted atop the needle pathway image at the intersection of the needle pathway with the skin surface within the frozen ultrasound image.

[0012] In some embodiments, the system includes a probe securing apparatus configured to secure the ultrasound probe to the patient to prevent movement of the ultrasound probe with respect to the patient while determining the ultrasound image of the target area.

[0013] In some embodiments, the probe securing apparatus is attached to the ultrasound probe, and is configured to attach to a skin surface of the patient adjacent the insertion site. Insome embodiments, a base of the probe securing apparatus includes an adhesive for attaching the probe securing apparatus to the skin surface.

[0014] In some embodiments, the probe securing apparatus includes a probe cover that defines a sterile barrier between the ultrasound probe and the patient. In some embodiments, the probe securing apparatus is attached to the ultrasound probe across the probe cover.

[0015] In some embodiments, the probe securing apparatus includes a needle guide coupled therewith, the needle guide configured to define a lateral position and an orientation of the needle with respect to the probe securing apparatus.

[0016] In some embodiments, the TLS sensor is physically attached to the probe securing apparatus, and in some embodiments, the TLS sensor is incorporated into the ultrasound probe.

[0017] Also disclosed herein is a method that, according to some embodiments, includes: (i) projecting, via an ultrasound probe of an ultrasound guidance system (UGS), ultrasound pulses into a target area of a patient; (ii) receiving, by the ultrasound probe, ultrasound echoes reflected off anatomic elements within the target area; (ii) converting the ultrasound echoes into electronic signals and further converting the electronic signals into ultrasound image data via electrical components of the UGS; (iv) processing, according to UGS logic of a console of the UGS, the ultrasound image data to define an ultrasound image of the target area; (v) depicting the ultrasound image on a display of the UGS; (vi) identifying an epidural / spinal space within the ultrasound image; (vii) detecting, by a tip location system (TLS) sensor attached to a skin surface of patient, a magnetic field defined by a magnetic element coupled with a needle at a distal tip of the needle, the needle inserted into the target area; (viii) converting electrical signals based on the magnetic field into tip location data via electrical components of the TLS; (ix) processing, according to logic of a console of the TLS, the tip location data to determine a location of the distal tip with respect the TLS sensor; and (x) overlaying a live distal tip image atop the ultrasound image in accordance with the location of the distal tip.

[0018] In some embodiments the method further includes freezing the ultrasound image on the display to define a frozen ultrasound image and overlaying the live distal tip image atop the frozen ultrasound image.

[0019] In some embodiments of the method, the TLS sensor includes an adhesive layer disposed along a bottom side of a housing of the TLS sensor, where the adhesive layer is configured to adhesively secure the TLS sensor to the skin surface.

[0020] In some embodiments of the method, the TLS sensor is wirelessly coupled with the UGS console.

[0021] In some embodiments of the method, identifying an epidural / spinal space includes processing the ultrasound image data according to logic of the UGS console.

[0022] In some embodiments, the method further includes processing the ultrasound image data according to the logic of the UGS console to determine a depth of the epidural / spinal space with respect to the skin surface and depicting the depth of the epidural / spinal space on the display.

[0023] In some embodiments, the method further includes processing the tip location data according to the logic of the TLS console to determine a depth of the distal tip with respect to the TLS sensor and depicting the depth of the distal tip on the display.

[0024] In some embodiments the method further includes providing a notification to the clinician when the depth of the distal tip is equal to the depth of the epidural / spinal space within a defined tolerance defined by the UGS logic.

[0025] In some embodiments, the method further includes processing the ultrasound image data, according to the logic of the UGS console, to define a needle pathway extending toward the epidural / spinal space and overlaying a needle pathway image atop the ultrasound image.

[0026] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0027] FIG. 1 is a block diagram depicting various elements of a needle guidance system, according to some embodiments of the disclosure.

[0028] FIG. 2 is a simplified view of the system of FIG. 1 in use with a back portion of a patient, according to some embodiments of the disclosure.

[0029] FIGS. 3 A-3B are views of an ultrasound probe of an ultrasound guidance system (UGS) of the system of FIG. 1, according to some embodiments of the disclosure.

[0030] FIG. 4A is illustration of the tip location / navigation system (TLS) including the TLS sensor detecting a magnetic field defined by the needle, according to some embodiments of the disclosure.

[0031] FIG. 4B is a block diagram of a console of the TLS system, according to some embodiments of the disclosure.

[0032] FIG. 5 is an illustration of the needle of the TLS accessing the epidural / spinal space of the patient, according to some embodiments of the disclosure.

[0033] FIGS. 6A-6B are screen shots as may be depicted on a display of the UGS of FIG. 1 showing a depth of an epidural / spinal space and a needle pathway image overlay ed atop of the ultrasound image, according to some embodiments of the disclosure.

[0034] FIG. 7 is a detailed illustration of the TLS system in use with the patient, according to some embodiments of the disclosure.

[0035] FIGS. 8A-8B are screenshots of images as may be depicted on a display of the UGS showing a live distal tip image overlayed atop of the ultrasound image in relation to the needle pathway image during advancement of the needle toward the epidural / spinal space, according to some embodiments of the disclosure.

[0036] FIG. 9 is a block diagram of the method of providing guidance for a needle accessing the epidural / spinal space, according to some embodiments of the disclosure.

[0037] FIGS. 10A-10B illustrate of a probe securing apparatus that may be employed with the needle guidance system of FIG. 1, according to some embodiments of the disclosure.

[0038] FIGS. 11A-11B illustrate another embodiment of a probe securing apparatus that may be employed with the needle guidance system of FIG. 1, according to some embodiments of the disclosure.

[0039] FIG. 12 is a side view illustration of another embodiment of a probe securing apparatus that may be employed with the needle guidance system of FIG. 1, according to some embodiments of the disclosure.

[0040] FIGS. 13A-13C illustrate another embodiment of a probe securing apparatus, according to some embodiments of the disclosure.

[0041] FIG. 14 illustrates another embodiment of a probe securing apparatus, according to some embodiments of the disclosure.

[0042] FIGS. 15A-15C illustrate another embodiment of a probe securing apparatus, according to some embodiments of the disclosure.

[0043] FIGS. 16A-16B illustrate another embodiment of a probe securing apparatus, according to some embodiments of the disclosure.

[0044] FIGS. 16C-16D illustrate another embodiment of a probe securing apparatus of FIGS. 16A-16B, according to some embodiments of the disclosure.

[0045] FIGS. 17A-17C illustrate another embodiment of a probe securing apparatus, according to some embodiments of the disclosure.

[0046] FIGS. 18A-18C illustrate another embodiment of an ultrasound probe that may be employed with the needle guidance system of FIG. 1, according to some embodiments of the disclosure.

[0047] FIGS. 18D-18F illustrate another embodiment of an ultrasound probe of FIGS. 18A-18C including a probe securing apparatus, according to some embodiments of the disclosure.

[0048] FIG. 18G illustrates another embodiment of an ultrasound probe of FIGS. 18D- 18F where the ultrasound probe omits the probe handle, according to some embodiments of the disclosure.DESCRIPTION

[0049] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of theconcepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0050] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0051] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0052] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end nearest a practitioner during use, and the distal end of a medical device is the end or portion nearest a patient during use. For example, the distal end or portion of a needle is the end or portion of the needle furthest disposed within the patient. Conversely, the proximal end or portion of the needle is the end or portion disposed outside the patient.

[0053] The term “logic” may be representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and / or storage functionality. Examples of suchcircuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.), a semiconductor memory, or combinatorial elements.

[0054] Additionally, or in the alternative, the term logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library / dynamic link library (dll), or even one or more instructions. This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of a non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the logic may be stored in persistent storage.

[0055] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

[0056] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, allembodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0057] Embodiments of the disclosure are generally directed to needle guidance system for use in providing guidance to a clinician to enable accurate placement of distal tip of a needle within an epidural / spinal space of a patient. Although, the embodiments of the disclosure may be utilized in accordance with other medical procedures, such as biopsy, peripheral nerve blocks, and targeted drug delivery, for example. Different tracking technologies such as, but not limited to, ultrasound, x-ray, fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT) scanning, pressure sensor stud finding, can be employed. In one embodiment, the needle guidance system employs two modalities for improving needle placement accuracy: 1) ultrasound-assisted guidance for introducing the needle into the patient's epidural / spinal space provided by an ultrasound guidance system (UGS); and 2) magnetically-based tracking of the needle tip during its advancement along the tortuous path to the epidural / spinal space provided by a tip location / navigation system (“TLS”), where the TLS is configured to detect and facilitate correction of any tip malposition during such advancement. The UGS and TLS according to one embodiment are combined to form an integrated system for use by a clinician accessing the epidural / spinal space. Integration of the UGS and TLS into a single device simplifies the needle placement process and results in relatively faster epidural / spinal space access. For instance, the integrated needle guidance system enables ultrasound and TLS activities to be viewed from a single display of the integrated system. Also, controls located on an ultrasound probe of the integrated device, which probe is maintained within the sterile field of the patient during catheter placement, can be used to control functionality of the system, thus precluding the need for a clinician to reach out of the sterile field in order to control the system. This also helps in clinicians to have both hand free for the procedure being conducted. A combination of the two modalities above according to one embodiment enables the needle guidance system to facilitate needle placement within the patient's epidural / spinal space with a relatively high level of accuracy, i.e., placement of the distal tip of the needle in a predetermined and desired position within the epidural / spinal space. However, the UGS may be configured for employment with other medical procedures that utilize ultrasound imaging separate from the TLS.

[0058] The needle guidance system is described in accordance with accessing the epidural / spinal space of a patient. However, needle guidance system may be employed to provide needle guidance to a clinician in accordance with any number of medical procedures that include the insertion, advancement, and / or placement of a medical device (e.g., an elongate device or probe) within a patient, such as vascular access procedures, biopsy procedures, urinary tract procedures, for example. As such, the epidural / spinal space are referred to herein may include any target location within a patient.

[0059] Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the disclosure and are neither limiting nor necessarily drawn to scale.

[0060] FIG. 1 illustrates various components of the needle guidance system (“system”), generally designated as 100, configured in accordance with some embodiments of this disclosure. As shown, the system 100 generally includes the UGS 110 and the TLS 112. The UGS 110 includes a console 120, display 130, and a probe 140, and the TLS generally includes a TLS sensor 162 and a needle 165. The console 120 includes a processor 122, e.g., a non- transitory computer-readable medium, having UGS logic stored thereon. The processor 122 performs operations as defined by the UGS logic to control system function during operation of the UGS 110 such as activating and deactivating the probe 140. In an embodiment, the operations may include transitioning an ultrasound image depicted on the display 130 between a real time live image and a frozen image.

[0061] A digital controller / analog interface 124 is also included with the console 120 and is in communication with both the processor 122 and other system components to govern interfacing between the probe 140 and other system components. The console 120 further includes ports 152 for connection with optional components 154 including a printer, storage media, keyboard, mouse pointer, etc. The ports 152 in one embodiment are USB ports, though other port types or a combination of port types can be used for this and the other interface connections described herein. A power connection 156 is included with the console 120 to enable operable connection to an external power supply 158. An internal power supply 150 (e.g., a battery) can also be employed, either with or exclusive of the external power supply 158. Power management circuitry 159 is included with the digital controller / analog interface 24 of the console 120 to regulate power use and distribution.

[0062] The display 130 in the illustrated embodiment is integrated into the console 120 and is used to display information to the clinician during the needle placement procedure. In another embodiment, the display 130 may be separate from the console 120. In one embodiment, a console button interface 132 and buttons included on the probe 140 can be used to perform various operations of the console 120, the probe 140, or the display 30. In one embodiment, information from the UGS 110 and the TLS 112 may be displayed simultaneously. Thus, the single display 130 of the console 120 can be employed for ultrasound guidance in accessing a patient’s epidural / spinal space and TLS guidance during needle advancement toward the epidural / spinal space. In one embodiment, the display 130 is an LCD device. In some embodiments, the display 130 may include a graphical user interface (GUI) such that the clinician may provide input to the UGS 110 via the display 130. In some embodiments, the GUI may support input a via a mouse pointer. In some embodiments, the console 120 may include a microphone (not shown) that enables the clinician to provide input to the UGS 110 via voice commands. During use of the system 100, manipulation of the needle 165 may require both hands. As such providing input via voice commands may be advantageous. Further, the console 120 may include a number of output devices (not shown), such as an audio transducer, a haptic transducer, and / or an illuminating device, for example, where the output devices are configured to provide notifications, alerts, and / or alarms to the clinician.

[0063] The probe 140 includes button and memory controller 142 for governing button and probe operation. The button and memory controller 142 can include non-volatile memory, such as EEPROM, in one embodiment. The button and memory controller 142 is in operable communication with a probe interface 144 of the console 120, which includes a piezo input / output component 144A for interfacing with the probe piezoelectric array and a button and memory input / output component 144B for interfacing with the button and memory controller 42.

[0064] The console 20 further includes a wireless module 53 configured to enable wireless communication between the UGS 110 and the TLS sensor 162 of the TLS 112. Other components, such as the optional components may be configured to wirelessly communicate with the UGS 110. In some embodiments, the UGS 110 may be coupled with the TLS sensor 162 via a wired connection such as through the ports 152.

[0065] FIG. 2 illustrates the general relationship of these components to a patient 70 during a placement procedure of the needle 165 into the epidural / spinal space 77 through a skin insertion site 73. It is noted that the general epidural / spinal space of the patient extends along the spine of the patient 70. The epidural / spinal space 77 as used herein refers to a portion or section of the general epidural / spinal space intended for placement of the needle 165. The needle 165 generally includes a proximal portion 266 that remains exterior to the patient 70 and a distal potion 267 disposed within the patient 70 during and after placement of the needle 165. The system 100 is employed to ultimately position a distal tip 268 of the needle 165 within the epidural / spinal space 77 of the patient 70. The proximal portion 266 further includes a hub 269 that provides for connection of a fluid deliver device thereto, such as a syringe, for example. In the illustrated embodiment, the needle 165 is a shown as a simple needle including the hub 269 at the proximal end of a cannula (or shaft) and a distal tip 268 at a distal end. However, in other embodiments, the needle 165 may include other components or features not shown, such as a stylet and / or a catheter for example.

[0066] The TLS sensor 162 is employed by the TLS 112 to magnetically determine a location of the needle 165 as further described below. As seen in FIG. 2, the TLS sensor 162 is placed on the patient 70 (e.g., on the back of the patient) in preparation for needle placement. The TLS sensor 162 is placed on the patient 70 in a predetermined location, such as through the use of external body landmarks (e.g., vertebrae), to enable the TLS 112 to detect and monitor the location of the needle 165 during needle advancement toward the epidural / spinal space 77. In some embodiments, the TLS sensor 162 may be incorporated into the probe 140. The TLS sensor 162 is communicatively coupled with the console 120 of the UGS 110 via the wireless module 153. The location of the needle 162 as determined by the TLS 112 is communicated to the UGS 110 so that the UGS 110 can graphically depict a distal tip image, e.g., an icon representing the distal tip 268, on the display 130.

[0067] FIGS. 3 A and 3B depict features of the probe 140 according to one embodiment. The probe 140 is employed by the UGS 110 to obtain an ultrasound image of the target area of the patient, where the target area includes the epidural / spinal space 77. The ultrasound image provides for visual guidance of the needle 165 toward the epidural / spinal space 77 and assists in reducing complications typically associated with such insertion, such as Dural puncture, for example.

[0068] The probe 140 includes a head 180 that houses a piezoelectric array for producing ultrasonic pulses and for receiving echoes thereof after reflection by the patient’s body (e.g., anatomic elements within the target area) when the head 180 is placed against the patient’s skin at the target area. The digital controller / analog interface 124 receives the echo signals from the piezoelectric array and converts that echo signals into ultrasound image data. The UGS logic processes the ultrasound image data to define the ultrasound image of the target area and depict the ultrasound image on the display 130. The probe 140 further includes a plurality of control buttons 184, which can be included on a button pad 182 disposed on a front side 140B of the probe 140. However, in some embodiments, the button pad 182 may be disposed on a back side 140C opposite the front side 140B. In the illustrated embodiment, the UGS 110 can be controlled by the control buttons 184 in accordance with the UGS logic, thus eliminating the need for the clinician to reach out of the sterile field, which is established about the patient insertion site 73 prior to needle placement.

[0069] In an embodiment, the UGS logic may be configured such that activating one or more of the control buttons 184 transitions the ultrasound image depicted on the display 130 the between a real time live image and a frozen image. For example, a clinician may adjust the location and / or orientation of the probe 140 until a real time live image depicted on the display 130 includes the epidural / spinal space 77, or more specifically a desired location of the distal tip 268 of the needle 165 is within the epidural / spinal space 77. At such a point, in some embodiments, the clinician may activate a button 184 to freeze the ultrasound image on the display 130. With the ultrasound image frozen, the clinician may discontinue use of the probe 140 leaving the frozen image depicted on the display 130. The UGS logic is also configured to overlay the distal tip image atop the ultrasound image depicted on the display 130, whether ultrasound image is the real time live image or the frozen image. In other embodiments, the distal tip image may be overlayed atop an image other than the ultrasound image, such as images obtained via x-ray, fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT) scanning, and pressure sensor stud finding, for example.

[0070] FIG. 4A is a detailed illustration of the TLS 112. As discussed above, the TLS 112 includes the TLS sensor 162 and the needle 165. The needle 165 includes a number of magnetic elements 410 (e.g., magnets or magnetic portions) disposed along the needle shaft 411 including at least a magnetic element 410A located at the distal tip 268. In some embodiments, the needle 165 may only include the magnetic element 410A. The needle 165may be formed of a magnesite material. The magnetic element 410A is preferably disposed immediately adjacent the distal tip 268 of the needle 165 so that the location of the magnetic element 41 OA is operatively coincident with the distal tip 268, (more specifically) so that when the magnetic element 410A is disposed within the epidural / spinal space 77, the distal tip 268 is also located within epidural / spinal space 77 and vice versa. The magnetic elements 410 define a magnetic field 412 extending away from the needle 165, where the magnetic field 412 is detectable by the TLS sensor 162 . In one embodiment, the location of the needle 165 can be determined and monitored using the teachings of one or more of the following U.S. patents and publications: 5,775,322; 5,879,297; 6,129,668; 6,216,028; 6,263,230; 9,554,716; 9,456,766; 9,492,097; 10,524,691; 10,449,330; and 2018 / 0116551. The contents of the afore-mentioned U.S. patents and publications are incorporated herein by reference in their entireties.

[0071] The TLS sensor 162 is shown having a housing 163 affixed to a skin surface 70A of the patient 70 via an adhesive layer 407. The adhesive layer 407 is configured to secure the TLS sensor 162 to the patient 70 such that the TLS sensor 162 is prevented from separation from and movement (including rotation) with respect to the patient 70 throughout the needle placement procedure. In use, the TLS sensor 162 is secured to the patient 70 over the target area, including the epidural / spinal space 77 and further including the intended / desired final location of the distal tip 268 of the needle 165 within the patient 70. More specifically, in some embodiments, the TLS sensor 162 may be placed generally within a proximity of the epidural / spinal space 77. In other embodiments, the TLS sensor 162 may be accurately placed directly over the epidural / spinal space 77. In some embodiments, the adhesive layer 407 removable from the TLS sensor 162 after use, so that a replacement adhesive layer 407 may be applied to the TLS sensor 162 in preparation for a subsequent use of the TLS sensor 162.

[0072] FIG. 4B is a block diagram of the TLS 112 including components of the TLS sensor 162 as may be enclosed within the housing 163. The TLS sensor 162 includes a power source 420 (e.g., a battery), a microcontroller 440 (including TLS logic 441 stored on a non- transitory computer-readable medium), a communication module 430 and a magnetic sensor 450 which may include a number (e.g., 2, 3, 4 or more) of magnetometers configured to detect the magnetic field 412 from different locations within the housing 163. The magnetic sensor 450 including the magnetometers detect strength and direction of the magnetic field 412 such that a location (including depth) of at least the magnetic element 410A with respect to the TLS sensor 162 is determinable. The communication module 430 includes a wireless capabilityaccording to the illustrated embodiment. As such, the TLS sensor 162 is configured to wirelessly communicate with the UGS system 110 via the wireless module 153. The microcontroller 440 is configured to receive electrical signals from the magnetic sensor 450 and convert the electrical signals into digital location data processable by the TLS logic 441. The TLS logic 441 processes the digital location data to determine the position (i.e., 3- dimensional location) of the magnetic element 410A with respect to TLS sensor 162 (i.e., the location of the TLS sensor 162). The TLS logic 441 communicates the location of the magnetic element 410A to the UGS 110. In some embodiments, the magnetic sensor 450 may be configured to detect an orientation of the needle 165 in addition to the location of the magnetic element 410A at the distal tip 268 of needle 165 and provide orientation data to the microcontroller 440 so that the TLS logic 441 may determine the orientation of the needle 165 with respect to an orientation of the TLS sensor 126 in addition to the location of the distal tip 268. The TLS logic 441 may also communicate the orientation of the needle 165 (i.e., the number of magnetic elements 410) to the UGS 110.

[0073] FIG. 5 is an illustration of a spinal portion of the patient 70 including the skin surface 70A, vertebrae 503, the epidural / spinal space 77 and dura matter 505. The epidural / spinal space 77 is located at a depth 512 from the skin surface 70A. The needle 165 is shown accessing the epidural / spinal space 77 along a pathway 510. The pathway 510 oriented at an insertion angle 514 with respect to the skin surface 70A. The insertion angle 514 may be an optimum insertion angle so as to avoid the vertebra 503 and / or allow for reliable access to the epidural / spinal space 77. For example, a shallower angle may allow for a catheter inserted through the needle to curve and extend along the epidural / spinal space 77.

[0074] FIG. 6A is an example of the ultrasound image 602 (i.e., a screen shot) of the spinal portion (target area) of the patient 70 of FIG. 5 as obtained by the ultrasound probe 140 and depicted on the display 130. The UGS logic is configured to depict a live ultrasound image on the display 130 so that the clinician may manipulate the ultrasound probe 140 to obtain an optimal image of the target area. The UGS logic may be configured to identify anatomical elements within the target area, such as the skin surface 70A, the vertebrae 503, and the epidural / spinal space 77, for example. Once the optimal image is obtained, the UGS logic may be configured to freeze the ultrasound image 602. In some embodiments, the UGS logic may be configured to freeze the ultrasound image 602 in response to input from the clinician, such as pressing one of the control buttons 184, or issuing a voice command, for example.

[0075] The epidural space 77 (i.e., a desired location of the distal tip 268) is identified from the ultrasound image 602. In some embodiments, the epidural space 77 may be identified via input by the clinician, such as clicking on the epidural space as visually observed on the display 130 with a mouse pointer, for example. In other embodiments, the UGS logic may be configured to automatically identify the epidural space 77 (i.e., differentiate the epidural space 77) from the other anatomical elements, such as via edge detection techniques, for example. The UGS logic may also determine the depth 512 (i.e., measure the depth 512) of the epidural space 77. In some embodiments, the UGS logic may depict the depth 512 on the display 130. The UGS logic may store the depth 512 in the memory 122 for future processing.

[0076] FIG. 6B is the ultrasound image 602 further illustrating a needle pathway 610 disposed and depicted at the insertion angle 614, which needle pathway 610 and insertion angle 614 are analogous to the pathway 510 and insertion angle 514 of FIG. 5. In some embodiments, the needle pathway 610 may be defined via input by the clinician, such as positioning and orienting a line segment overlayed onto the ultrasound image 602 extending between the epidural / spinal space 77 and the skin surface 502 for example. It is noted that the skin surface 502 is an image of the skin surface 70Aof FIG. 5. In other embodiments, the UGS logic may be configured to automatically define the needle pathway 610, including the insertion angle 614, based at least on the anatomical elements identified within the ultrasound image 602. The needle pathway 610 may extend to and / or intersect the skin surface 502. With the needle pathway 610 defined, the UGS logic may be configured to overlay a needle pathway image 611 (e.g., an icon representing the needle pathway 610) atop the frozen ultrasound image in alignment with the needle pathway 610. By way of summary, the UGS logic may be configured to (i) obtain the ultrasound image 602, (ii) freeze the ultrasound image 602, (iii) identify the epidural / spinal space 77 within the ultrasound image 602, (iv) determine depth of the epidural / spinal space 77 from the skin surface 502, and (v) define a needle pathway 610 extending toward the epidural / spinal space 77 including the angle 614, and (vi) overlay the needle pathway image 611 atop the frozen ultrasound image 602. In some embodiments, the needle pathway image 611 may extend to and / or beyond the skin surface 502. In some embodiments, the UGS logic may be configured to overlay the needle pathway image 611 atop the ultrasound image 602 in a live state versus a frozen state.

[0077] FIG. 7 is an illustration of the spinal portion of the patient 70 of FIG. 5 further including the TLS sensor 162 secured to the skin surface 70A. The needle 165 is shownaccessing the epidural / spinal space 77 such that the magnetic element 410A disposed at the distal tip 268 of the needle 162, is disposed within the epidural / spinal space 77. The TLS logic is configured to determine the location and orientation of the needle 165 in 3-dimensional space based on the magnetic field 412. Accordingly, the TLS logic can determine the depth 712 of the magnetic element 410A, i.e., a distance from the bottom side TLS sensor 162 (i.e., the bottom side of the housing 163) to the magnetic element 41 OA which is analogous to the depth of the distal tip 268 from the skin surface 70A. The TLS logic can further determine the angle 714 of the needle 165 with respect to the TLS sensor 162 including the bottom side of the TLS sensor 162 which is analogous to the insertion angle 514 of FIG. 5. By way of summary, the TLS 112 tracks the position of the distal tip 268 of the needle 162 and / or the orientation of the needle 162 in 3-dimenstional space with respect to the TLS sensor 162 during insertion / advancement of the needle 165 toward the epidural / spinal space 77 independent of the UGS 110. The TLS communicates tracking data (i.e., the location of the distal tip 268 and / or the orientation of the needle 162) to the UGS for depiction on the display 130.

[0078] In some embodiments, the TLS 112 may track the position of the distal tip 268 and / or the orientation of the needle 162 prior to insertion of the distal tip through the skin surface 70A. According to one embodiment, the TLS logic may determine the location of the distal tip 268 with respect to TLS sensor 162 when the distal tip 268 is positioned at the insertion site 73 (before insertion) to define a TLS baseline location of the distal tip 268. As the needle pathway 610 extends to the skin surface 502 in the frozen ultrasound image, the UGS logic may define the location of the pathway 610 at the skin surface 502 as a UGS baseline location. Since, the UGS baseline location and the TLS baseline location are both include the insertion site 73, the UGS logic may digitally collocate the UGS baseline location and the TLS baseline location, thereby correlating the frozen ultrasound image 602 with the position of the TLS sensor 162 on the patent 70, so that when the clinician positions the distal tip 268 at the insertion site and the TLS 112 determines the position distal tip 268, the distal tip image 868 (see FIG. 8 A) is depicted coincident with the needle pathway 610 at the skin surface 502 within the frozen ultrasound image 602.

[0079] FIGS. 8A, 8B illustrate the ultrasound image 602 (i.e., a screen shot depicted on the display 130) in the frozen state including the needle pathway image 611 extending toward the epidural / spinal space 77 overlayed atop the ultrasound image 602. Further illustrated is a live distal tip image 868 (i.e., an image representing the distal tip 268 of the needle 162)overlayed atop the ultrasound image 602. A needle image 862 (i.e., an image representing the needle 162) may also be depicted indicating an orientation of the needle 165. As such, the clinician may observe an orientation of the needle image 862 with respect to the needle pathway image 611. FIG. 8A illustrates the live distal tip image 868 piercing the skin surface 502 adjacent / atop the needle pathway image 611. FIG. 8B illustrates the live distal tip image 868 tracking along the needle pathway image 611 to the epidural / spinal space 77. As such, the clinician may observe the position of the distal tip image 868 in relation to the needle pathway image 611 during advancement of the needle 162 and visually observe when the distal tip image 868 is positioned within the epidural / spinal space 77.

[0080] Although not shown in FIGS. 8 A, 8B, the screen shots 602 may include a depth (e.g., 3.5 cm) of the of the epidural / spinal space 77 in relation to the skin surface 502 such as shown in FIG. 6A. In a similar fashion, the screen shots 602 may include a depth of the distal tip 268 in the relation to the skin surface (i.e., the bottom side of the TLS sensor 162) as determined by the TLS logic. As such, the clinician may observe the relationship between the depth (e.g., 3.5 cm) of the of the epidural / spinal space 77 and the depth of the distal tip 268.

[0081] In some embodiments, as the TLS 112 continuously (i.e., live) communicates the tracking data the UGS 110 so that the distal tip image 868 can be overlay ed live atop the frozen ultrasound image 602, the UGS logic can monitor the depth 712 of the distal tip 268 and compare the depth 712 to the depth 512 of the epidural / spinal space 77. When the depth 712 of the distal tip 268 is equal to the depth 512 of the epidural / spinal space 77 within a defined tolerance stored in memory, the UGS logic may generate a notification (visual or audible) to the clinician indicating that the distal tip 268 is within the epidural / spinal space 77. Similarly, the UGS logic may generate an alert or alarm (visual or audible) to the clinician when the depth 712 of the distal tip 268 is exceeds the depth 512 of the epidural / spinal space 77 beyond the defined tolerance indicating that the distal tip 268 has entered the dura matter 505.

[0082] FIG. 9 is a block diagram of a method 900 of providing guidance to clinician during advancement of the needle toward the epidural / spinal space. It is to be understood that while the method 900 pertains to guidance of the needle toward the epidural / spinal space, the method 900 may be utilized to provide guidance for the insertion of any elongate medical device into a patient body toward any defined target location without substantially deviating from the method 900 as described below. The method 900 includes all or any subset of the steps, actions or processes described below. The method 900 is performed by system 100according to the UGS logic and / or the TLS logic describe above. The method 900 includes obtaining an ultrasound image of a target area (block 910). Obtaining the ultrasound image, according to some embodiments, may include: (i) projecting, via the ultrasound probe of UGS, ultrasound pules into a target area of a patient; (ii) receiving, by the ultrasound probe, ultrasound echoes reflected off anatomic elements within the target area; (iii) converting the ultrasound echoes into electronic signals and further converting the electronic signals into ultrasound image data via electrical components of the UGS; and (iv) processing, according to the UGS logic, the ultrasound image data to define an ultrasound image of the target area. The method 900 may further include depicting the ultrasound image on a display of the UGS (block 920) and identifying an epidural / spinal space within the ultrasound image (block 930). In some embodiments of the method 900, identifying the epidural / spinal space includes processing by the UGS logic to automatically define the epidural / spinal space. In other embodiments, the UGS logic may identify the epidural / spinal space via input from the clinician. For example, the clinician may visually identify the epidural / spinal space within the ultrasound image and click on the epidural / spinal space with a mouse pointer.

[0083] The method 900 may further include freezing the ultrasound image on the display to define a frozen ultrasound image (block 940). Freezing the ultrasound image allows the clinician to discontinue use of the ultrasound probe and lay the ultrasound probe aside so that the clinician can use both hands to manipulate the needle during advancement of the needle toward the epidural / spinal space. In some embodiments, the method 900 may omit freezing the ultrasound image on the display.

[0084] The method 900 may further include tracking the location of the distal tip of needle tip within the target area (block 950). Tracking the location of the distal tip, according to some embodiments, may include: (i) detecting, by the TLS sensor attached to a skin surface of patient, a magnetic field defined by a magnetic element coupled with the needle at the distal tip; (ii) converting electrical signals based on the magnetic field into tip location data via electrical components of the TLS; and (iii) processing, according to the TLS logic, the tip location data to determine a location of the distal tip with respect the TLS sensor. The method 900 may further include overlaying a live distal tip image atop the ultrasound image in accordance with the location of the distal tip (block 960). In some embodiments of the method 900, the TLS sensor includes an adhesive layer disposed along a bottom side of a housing ofthe TLS sensor, where the adhesive layer is configured to adhesively secure the TLS sensor to the skin surface.

[0085] The method 900 may further include determining a depth of the epidural / spinal space from the skin surface (block 970). In some embodiments, determining the depth of the epidural / spinal space includes processing the ultrasound image data by the UGS logic to determine a depth of the epidural / spinal space. The method 900 may also include depicting the depth of the epidural / spinal space on the display.

[0086] The method 900 may further include determining a depth of the distal tip from the skin surface (block 980). In some embodiments, determining the depth of the distal tip includes processing the tip location data by the TLS logic of the TLS determine the depth of the distal tip with respect to the TLS sensor which is placed on the skin surface. The method 900 may further include depicting the depth of the distal tip on the display. The method 900 may further include providing a notification to the clinician when the depth of the distal tip is equal to the depth of the epidural / spinal space within a defined tolerance defined by the UGS logic. More specifically, the UGS logic may compare the depth of the epidural / spinal space with the depth of the distal tip and as a result of the comparison, provide the notification when the depth of the epidural / spinal space and the depth of the distal tip are equal within a defined tolerance stored in the UGS memory.

[0087] The method 900 may further include defining a needle pathway extending through the target area toward the epidural / spinal space (block 990). Defining the needle pathway may, according to some embodiments, include processing the ultrasound image data by the UGS logic to define a desirable needle pathway through the anatomic elements included in the ultrasound image. In other embodiments, the UGS logic may define the needle pathway via input from the clinician. For example, the clinician may visually define the needle pathway within the ultrasound image by clinking on a number of locations on the image with a mouse pointer. The method 900 may further overlaying a needle pathway image atop the ultrasound image to provide a visually guide toward the epidural / spinal space.

[0088] During use of the system 100, the clinician (or other user) may perform a method of accessing the epidural / spinal space that includes all or any subset of the flowing steps or actions. The clinician may identify a target area of the patient, such an area through which the clinician may insert a needle into the epidural / spinal space. The clinician may attachthe TLS sensor to the skin surface of the patient at the target area. The clinician may place the ultrasound probe in contact with the patient adjacent the target to obtain the ultrasound image. The clinician may adjust the ultrasound probe to obtain an optimal ultrasound image. Upon obtaining the optimal ultrasound image, the clinician may push a button on the ultrasound probe (or provide other input) to freeze the ultrasound image on the display. The clinician may separate the ultrasound probe and lay it aside. The clinician may provide input to the system to initiate a needle pathway definition process of the system, where upon completion, the system depicts a needle pathway image atop the frozen ultrasound image or in some embodiments, the live ultrasound image. The clinician may position the needle at the insertion site on the skin surface and provide input to system to initiate a correlation process of the system that correlates the position and / or orientation of the needle, as determined by the TLS, with the ultrasound image so that when the needle is positioned at the insertion site on the skin surface, a live distal tip image is located at the intersection of the needle pathway image with the skin surface atop the frozen ultrasound image or in some embodiments, the live ultrasound image. The clinician may advance the needle toward the epidural / spinal space while monitoring the display showing the live distal tip image in relation to the needle pathway image. The clinician may manipulate the needle during advancement so that the live distal tip image tracks along the needle pathway image toward the epidural / spinal space. The clinician may monitor the depth of the distal tip as depicted on the display in relation to the depth of the epidural / spinal space as also depicted on the display. The clinician may discontinue advancement of the needle when the depth of the distal tip is equal to the depth of the epidural / spinal space.

[0089] In some instances, it may be advantageous to maintain the live ultrasound image depicted on the display 130 during the insertion of the needle into the epidural space. Accordingly, an alternative embodiment of the method 900 may omit freezing on the ultrasound image (block 940) and modify block 960 to include overlaying the distal tip image atop the live ultrasound image. In such, instances it may be desirable to attach the probe 140 to the patient 70 so that the clinician need not manually hold the probe 140 in place during the procedure. FIGS. 10A-18G and the description that follows show and describe various embodiments of a probe securing system or apparatus configured to maintain an established position and orientation of the probe 140 with respect to the patient 70 during the needle insertion procedure. The probe securing system may also include a needle guiding mechanism that constrains the needle 165 at an established location and orientation of the needle 165 with respect to the ultrasound probe and / or the patient during the needle insertion procedure.

[0090] FIG. 10A illustrates a probe securing system (or apparatus) 1000 in accordance with some embodiments disclosed herein. The probe 140 is shown in use with the probe securing system 1000. The probe securing system 1000 is generally configured to enable the clinician to manually establish a position and an orientation of the probe with respect to the patient 70 such that a desired live ultrasound image is obtained by the probe 140. The probe securing system 1000 is further configured to maintain the established position and orientation of the probe 140 so that the clinician may let go of the probe 140 while the probe 140 continues to obtain the desired live ultrasound image.

[0091] The probe securing system 1000 generally includes a base 1010, a frame member 1020, and a probe attachment mechanism 1030. The frame member 1020 may be rotatably coupled with the base 1010 via a hinge 1015 so that an orientation of the frame member 1020 is adjustable with respect to the base 1010. The hinge 1015 includes a rotation resistance component 1015 A which is configured to (i) allow orientation adjustment of the frame member 1020 with respect to the base 1010 via manual manipulation by the clinician and (ii) maintain an established orientation of the frame member 1020 with respect to the base 1010 in the absence of the manual manipulation by the clinician. The rotation resistance component 1015 A may include any suitable components or features that provide the rotation resistance, such as friction or detents, for example.

[0092] In some embodiments, the rotation resistance component 1015 A may include a self-locking mechanism configure to transition from a locked state preventing rotation to an un-locked state allowing rotation via pressing or deflecting a spring-loaded actuator (not shown). Upon pressing or deflecting the spring-loaded actuator, the self-locking mechanism transitions from the locked state to the un-locked state, and upon releasing the spring loaded actuator, the self-locking mechanism self-transitions back to the locked state from the unlocked state.

[0093] The probe attachment mechanism 1030 is coupled between the frame member 1020 and the probe 140. The probe attachment mechanism 1030 is configured for selective attachment to and detachment from the probe 140. The probe attachment mechanism 1030 is configured to define a rigid connection between the probe 140 and the frame member 1020. In other words, when the probe attachment mechanism 1030 is attached to the frame member 1020, the lateral position and the orientation to the probe 140 with respect to the frame member 1020 is fixed. In the illustrated embodiment, the probe 140 may be longitudinally positionablewith respect to the probe attachment mechanism 1030 so that the clinician may adjust the position or contact of the head 180 of the probe 140 with respect to the skin of the patient 70.

[0094] In the illustrated embodiment, the probe attachment mechanism 1030 is configured for selective attachment to and detachment from the probe 140. As such, the probe attachment mechanism 1030 and / or the probe 140 may include any suitable attachment components or features that facilitate the selective attachment and detachment, such as clips, rails, snap fits, hooks, deflectable members, friction, or an adhesive, for example. The probe 140 defines the front side 140B and the back side 140C as described above. In the illustrated embodiment, the probe attachment mechanism 1030 extends along the front side 140B, and further extends around the probe 140 to the back side 140C of the probe 140. Although not shown, in some embodiments, the probe attachment mechanism 1030 extend entirely around the probe 140. Furthermore, in other embodiments, the probe attachment mechanism 1030 extends along the back side 140C, and around the probe 140 to the front side 140C of the probe 140.

[0095] The base 1010 is configured to couple with the patient 70 (e.g., the skin surface of the patient) during use. The frame member 1020 extends away from the base 1010 so as to extend away from the skin surface of the patient 70. The frame member 1020 includes a needle guide 1045. The needle guide 1045 is generally configured to engage the needle 165 so as to define a lateral location and an orientation of the needle 165 with respect to the patient 70 during insertion of the needle 165. In the illustrated embodiment, needle guide 1045 is located adjacent (or extends away from) the front side 140B of the probe 140. However, in other embodiments, the needle guide 1045 may be located adjacent (or extends away from) the back side 140C of the probe 140.

[0096] The probe securing system 1000 further includes a TLS sensor 1062 which may resemble certain features and functionalities of the TLS sensor 162 described above. In the illustrated embodiment, the TLS sensor 1062 is physically coupled (e.g., incorporated into the frame member 1020). In an alternative embodiment, the TLS sensor 1062 may be incorporated into the probe 140.

[0097] The probe securing system 1000 further includes a probe cover 1002 that defines a sterile barrier. A cable connection 140A of the probe 140 extends through an opening 1002A of the probe cover 1002. The probe cover 1002 and / or the probe attachment mechanism1030 are configured such that the probe cover 1002 defines a sterile barrier between the probe 140 and the probe attachment mechanism 1030. For example, the probe attachment mechanism 1030 may be configured to attach to the probe 140 across the probe cover 1002. In other words, the probe cover 1002 may be configured to prevent direct physical contact of the probe 140 with the probe attachment mechanism 1030. In some embodiments, the probe 140 may be non- sterile and the probe attachment mechanism 1030 may be sterile.

[0098] FIG. 10B is a perspective front view of the base 1010 and the frame member 1020 illustrating further details of the base 1010 and the frame member 1020 according to some embodiments disclosed herein. The base 1010 may define a generally flat plate-like shape including front side 1010A, a back side 1010B, a top side 1010C and bottom side 1010D (i.e., patient contact side). In the illustrated embodiment, the hinge 1015 may extend along the back side 1010B. Although in other embodiments, the hinge 1015 may extend along the front side 1010A or along the base 1010 at any location between the back side 1010B and the front side 1010A.

[0099] The base 1010 may include a patient securement mechanism 1012 configured to adhere the base 1010 to the patient 70. In the illustrated embodiment, patient securement mechanism 1012 include an adhesive layer 1012A disposed on the bottom side 1010D configured to attach the base 1010 to the skin surface of the patient 70. The adhesive layer 1012A may extend across an entire surface area of the bottom side 1010D or a portion the surface area of the bottom side 1010D. In other embodiments, the patient securement mechanism 1012 may include a mechanism other than an adhesive, such as an adhesive tape, a suction cup or a weighted portion, for example. The patient securement mechanism 1012 may be configured to enable the clinician to transition the patient securement mechanism 1012 between a non-adhering state and an adhering state after the clinician has established a location of the probe securing system 1000 on the patient. In some instances, establishing the location of the probe securing system 1000 may include adjusting the location in conjunction with obtaining the ultrasound image. As such, once the location has been established, it may be desirable to transition the patient securement mechanism 1012 from the non-adhering state to the adhering state while maintaining the established location.

[0100] In the illustrated embodiment, the adhesive layer 1012A is configured to transition from non-adhering state to the adhering state without removing the probe securing system 1000 from the patient (i.e., decoupling the base 1010 from the patient) or altering theestablished location of the probe securing system 1000. The patient securement mechanism 1012 may include a non-adhesive layer 1012B (e.g., a plastic film, adhesive backing) extending across the adhesive layer 1012A so as to be disposed between the adhesive layer 1012A and the skin surface of the patient 70. The non-adhesive layer 1012B includes a pull tab 1012C extending away from the adhesive layer 1012A. The non-adhesive layer 1012B is configured to be removed from the adhesive layer 1012A to enable the adhesive layer 1012A to directly contact the skin surface and adhere thereto by pulling on the tab 1012C. In some embodiments, the non-adhesive layer 1012B may be folded over on itself (as shown) such that pulling on the tab 1012C peels that the non-adhesive layer 1012B from the adhesive layer 1012A. As such, the clinician may maintain the established location of the probe securing system 1000 with one hand while pulling on the tab 1012C with the other hand.

[0101] The base 1010 may generally include a rectangular shape. Although other shapes, such as circular or oval shapes are considered. The base 1010 may include one or more cut outs 1011 so that the base 1010 does not obstruct insertion of the needle 165. In the illustrated embodiment, the base 1010 may include a substantially planar shape. In other embodiments, the base 1010 may include one or more pre-formed curves such as between the front side 1010A and the back side 1010B and / or between a left side 1010E and a right side 1010F. In other embodiments, the base 1010 may be plastically deformable from a first shape (e.g., a planar shape) to a second shape that includes any number of curves so that the base 101 may be deformed to match or follow a contour of the patient’s skin surface. In some embodiments, the base 1010 may include a metallic layer that is configured to allow the clinician define one or more curves of the base 1010 and to maintain the one or more curves once defined.

[0102] The frame member 1020 includes a compartment 1022 configured to receive the TLS 1062. In some embodiments, the compartment 1022 is configured to sealably encapsulate TLS 1062. In some embodiments, the TLS 1062 may disposed within the compartment 1022 during manufacturing of the frame member 1020. In other embodiments, the TLS 1062 may be placed within the compartment 1022 at a later time, such as placed within the compartment 1022 by the clinician at the time of use. Placing the TLS 1062 within the compartment 1022 at the time of use enables the frame member 1020 to be sterilized via conventional techniques with effecting the operation of the TLS 1062. During use, the clinician may adjust the orientation of the frame member 1020 with the respect to the base 1010 via thehinge 1015 to establish at least a partial orientation of the probe 140 and / or the TLS 1062 with respect to the patient 70.

[0103] In the illustrated embodiment, the frame member 1020 includes needle guiding mechanism 1040 that includes the needle guide 1045. The needle guiding mechanism 1040 enables adjustment of the needle guide 1045 with respect to the frame member 1020. As discussed above, the needle guide 1045 defines a lateral position and the orientation of the needle 165. In the illustrated embodiment, the needle guide 1045 includes lumen that matches the outside diameter of the needle 165. As such, the needle guiding mechanism 1040 facilitates adjustment of the needle 165 with respect to the patient 70. The needle guiding mechanism 1040 enables adjustment of the needle guide 1045 with respect to the frame member 1020 in accordance multiple degrees of freedom. The multiple degrees of freedom may include a lateral left to right position of the needle guide 1045 across the frame member 1020 as indicated by the left and right arrows of FIG. 10B. The multiple degrees of freedom may further include a lateral up to down position of the needle guide 1045 across the frame member 1020 as indicated by the up and down arrows of FIG. 10B. The multiple degrees of freedom may further include a lateral rotation of the needle guide 1045 such a distal direction of needle 165 is adjusted between an upward direction and a downward direction with respect to the frame member 1020 as indicated by the up and down arrows. The multiple degrees of freedom may further include a lateral rotation of the needle guide 1045 such a distal direction of needle 165 is adjusted between the right direction and the left direction with respect to the frame member 1020 as indicated by the right and left arrows. The needle guiding mechanism 1040 may include any suitable components or features that enable the adjustment of the needle guide 1045 across the multiple degrees of freedom, such a ball and socket joint, pivot points disposed in orthogonal orientations, sliding rails disposed in right to left and / or up to down directions, and the like.

[0104] The base 1010, the frame member 1020 and the probe attachment mechanism 1030 (including the components of each) may include any suitable materials, such plastic or metallic materials formed via manufacturing processes know in the art. The probe securing system 1000 may be configured for single use, i.e., may be a disposable item. The probe securing system 1000 including the probe cover 1002 may also be provide in a sterilized state. In other embodiments, the probe securing system 1000 as whole or any portion thereof may be configured for multiple uses across multiple patients.

[0105] FIGS. 11 A, 1 IB illustrate another embodiment of a probe securing system 1100 that can, in certain respects, resemble components of the probe securing system 1000 described in connection with FIGS. 10 A, 10B. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “11.” For instance, the base is designated as “1010” in FIGS. 10A, 10B, and an analogous base is designated as “1110” in FIGS. 11 A, 11B. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the probe securing system 1000 and related components shown in FIGS. 10 A, 10B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the probe securing system 1100 of FIG. 11. Any suitable combination of the features, and variations of the same, described with respect to the probe securing system 1000 and components illustrated in FIGS. 10 A, 10B can be employed with the probe securing system 1100 and components of FIGS. 11 A, 11B, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

[0106] FIG. 11A is a side view of the probe securing system 1100 and FIG. 1 IB is a front view of the probe securing system 1100, where both FIGS. 11 A, 1 IB show the probe 140 including the probe cover 1102 coupled with the probe securing system 1100, according to some embodiments disclosed herein. The probe securing system 1100 includes the base 1110 including the adhesive layer 1112A disposed on a bottom side thereof. A needle guiding mechanism 1140 having a needle guide 1145 is coupled with the base 1110.

[0107] A probe attachment mechanism 1130, which includes features of the frame member 1030, is attached to the base 1110. The probe attachment mechanism 1130 includes left and right attachment arms 1131 A, 113 IB that extend along right and left sides 140D, 140E of the probe 140. The left and right attachment arms 1131 A, 113 IB may be coupled with the base 1110 via left and right hinges 1115 A, 1115B that enable the left and right attachment arms 1131 A, 113 IB to rotate with respect to the base 1110. Spring loaded components 1132 (e.g., compressible members such as elastomeric protrusions) are coupled with the left and right attachment arms 1131 A, 113 IB so as to be disposed between the probe 140 and the left andright attachment arms 1131 A, 113 IB. The left and right attachment arms 1131 A, 113 IB define a compressing force on the spring-loaded components 1132 so that the spring-loaded components 1132 define a friction force with the probe 140 that secures the probe 140 to the left and right attachment arms 1131 A, 113 IB. The left and right attachment arms 1131 A, 113 IB may be displaceable or deflectable toward and away from each other so that the spring- loaded components 1132 can be selectively transitioned between a free state and a compressed state, thereby selectively securing and releasing the probe 140.

[0108] Each of left and right attachment arms 1131 A, 113 IB may include deflectable portion so that the respective arm may define a curved shape, where the arm maintains the curved shape to at least partially define a front to back orientation of the probe 140 as indicated by the double end arrow 1133. In some embodiments, the deflectable portion may include a series of articulating elements, pivot points, ball and socket joints, and the like. In other embodiments, the deflectable portion may include a bendable portion. In some embodiments, the deflectable portion may be configured to enable manual bending of the arm in any direction, i.e., right to left, front to back or any combination thereof. In the illustrated embodiment, the TLS 1162 may be incorporated into the probe 140. In alternative embodiments, the TLS 1162 may be incorporated into the base 1110.

[0109] FIG. 12 is a side view of the probe securing system or apparatus 1200 according to some embodiments disclosed herein. The probe 140 including the probe cover 1202 and the needle 165 are shown coupled with the probe securing system 1200. The probe securing system 1200 includes the base 1210 including the adhesive layer 1212A disposed on the bottom side 1210D. A frame member 1220 is fixedly attached to the base 1210 and a first vertical extension 1220 A of the frame member 1220 extends upward away from the base 1210 in a direction that is substantially perpendicular to the bottom side 1210D of the base 1210. A probe attachment mechanism 1230 is securely attached to the probe 140. A second vertical extension 1230A of the probe attachment mechanism 1230 extends along the backside 140C of the probe 140. An arm 1230B of the probe attachment mechanism 1230 extends around the probe 140 to the front side 140B of the probe 140. A needle guiding mechanism 1240 having a needle guide 1245 is coupled with the arm 1230B. In some embodiments, the arm 1230B may extend along the front side 140B toward a center of the front side 140B such that the needle guiding mechanism 1240 is located substantially at the center of the front side 140B. An ultrasound gel 1203 is disposed along a bottom side 140F of the probe 140 so as to be disposed between the head 180 (see FIG.3 A) and the skin surface for the purpose of defining an ultrasound connection between the head 180 and the skin.

[0110] The first vertical extension 1220A is operatively coupled with the second vertical extension 1230A via a ratchet mechanism 1224 that includes a ratchet strip and a slider that includes a spring-loaded release mechanism (not shown). The ratchet strip and the slider are configured to allow the slider to freely displace along the ratchet strip in one direction and prevent the slider from displacing along the ratchet strip in the opposite unless the release mechanism is activated by the clinician. The ratchet mechanism is coupled between the first vertical extension 1220 A of the frame member 1220 and the second vertical extension 1230 A of the probe attachment mechanism 1230 so that the probe attachment mechanism 1230 is allowed to freely displace toward the patient and so that the probe attachment mechanism 1230 is prevented from displacing away from the patient unless the release mechanism of the slider is activated by the clinician. As such, during use, the clinician may freely displace the probe 140 toward the patient to establish the ultrasound connection with the patient. Thereafter, the probe 140 is prevented from displacing away from the patient 70 unless the clinician activates the release mechanism of the slider.[oni] FIGS. 13A-13C illustrate probe securing system 1300 according to some embodiments disclosed herein. FIG. 13 A is a perspective view of a probe 1340 that may in certain respects resemble the features and functionality of the probe 140. FIG. 3B is a perspective view of a base 1310 and FIG. 13C is a perspective view of the probe securing system 1300 in a use state where the probe 1340 is coupled with the base 1310. The probe 1340 includes a probe head (see FIG. 3 A) disposed on a bottom side 1340F of the probe 1340. A frame member 1320 is coupled with the probe 1340 on a top side 1340G of the probe 1340. The frame member 1320 includes a pair of frame arms 1327, 1328. Each arm includes a first section (indicated by suffix “A”) rotatably coupled with a second section (indicated by suffix “B”) best shown in FIG. 13C. Each of the frame arms 1327, 1328 are rotatably coupled with the probe 1340. In FIG. 13 A, the frame arms 1327, 1328 are rotated to an upright storage state, and each second section is rotated with respect to the respective first section so as to be disposed along the respective first section. In the upright storage state, the frame arms 1327, 1328 may be disposed laterally adjacent each other.

[0112] Referring to FIG. 13B, the base 1310 includes hoop member 1319 extending along a closed perimeter of an oval shaped opening 1316. The hoop member 1319 includes theadhesive layer 1312A disposed across a bottom side thereof. The base 1310 further includes a pair of rails 1317, 1318 extending across the opening 1316. Each end of the rails 1317, 1318 is attached to the hoop member 1319. The rails 1317, 1318 are disposed parallel to one another. A space between the rails 1317, 1318 is configured receive the probe 1340 therein.

[0113] Referring to FIG. 13C, the probe 1340 is disposed between the rails 1317, 1318. The frame arms 1327, 1328 are rotated approximately 90 degrees in relation to the upright storage state of FIG. 3 A so that the first section 1327A and the first section 1328 A extend away from each other and laterally away from the probe 1340. The second section 1327B is rotated with respect to the first section 1327A so that the second section 1327B extends vertically downward toward the patient 70. A hook 1337 disposed at the free end of the second section 1327B engages a slot 1317A of the rail 1317. Similarity, the second section 1328B extends vertically downward toward the patient 70, and a hook 1338 disposed at the free end of the second section 1328B engages a slot 1318A of the rail 1318. As such, the engagement of the frame arms 1327, 1328 with the rails 1317, 1318 secures the probe 1340 to the base 1310. The slots 1317A, 1318 A extend along a length of the rails 1317, 1318, respectively so that the probe 1340 is longitudinally positionable along rails 1317, 1318.

[0114] Although not required, the probe securing system 1300 may include a needle guiding mechanism 1360 having a needle guide 1365 (shown in block form via phantom lines) coupled with the probe 1340. The needle guiding mechanism 1360 having a needle guide 1365 may in certain respects resemble the needle guiding mechanism 1040 and the needle guide 1045 of FIG. 10B. Similarly, the probe 1340 may include the TLS sensor 162 incorporated therein.

[0115] FIG. 14 illustrates probe securing system 1400 according to some embodiments disclosed herein. FIG. 14 is a perspective view of the probe securing system 1400 including a probe 1440 that may in certain respects resemble the features and functionality of the probe 1340. The probe securing system 1400 includes a base defined by a first rail 1417 and second rail 1418 which are each configured for placement on the patient 70. In some embodiments, the first and second rails 1417, 1418 may include a patient securement mechanism 1412 (e.g., an adhesive layer) disposed on bottom sides 1417B, 1418B of the first and second rails 1417, 1418, where the patient securement mechanism 1412 is configured to attach the first and second rails 1417, 1418 to the skin surface 70A of the patient 70. In some embodiments, the first andsecond rails 1417, 1418 may be disposed parallel with each other, and in some embodiments, the probe 1440 may be disposed between the first and second rails 1417, 1418.

[0116] A frame member 1420 is coupled with the probe 1440. The frame member 1420 includes first and second frame arms 1427, 1428 which extend (i) away from opposite lateral sides of the probe 1440 and (ii) downward toward the patient 70. The first and second frame arms 1427, 1428 include a first and second feet 1437, 1438, respectively, where the first and second feet 1437, 1438 slidably engage the first and second slots 1417A, 1418A of the first and second rails 1417, 1418, respectively. The first and second slots 1417A, 1418A are configured to allow the first and second feet 1437, 1438 to longitudinally displace along the first and second rails 1417, 1418 without allowing separation of the first and second feet 1437, 1438 from the first and second rails 1417, 1418.

[0117] A probe attachment mechanism 1430 is coupled between the frame member 1420 and the probe 1440. The probe attachment mechanism 1430 is configured for selective attachment to and detachment from the probe 1440, such as via a cable connection portion 1440A of the probe 1440, for example. In some embodiments, probe attachment mechanism 1430 is configured to couple the probe 1440 to the probe securing system 1400 such that a cable 1440B extends away from the probe 1440 in a direction that is parallel with the first and second rails 1417, 1418.

[0118] Although not required, the probe securing system 1400 may include a needle guiding mechanism 1460 having a needle guide 1465 (shown in block form via phantom lines) coupled with the probe 1440. The needle guiding mechanism 1460 having the needle guide 1465 may in certain respects resemble the needle guiding mechanism 1040 and the needle guide 1045 of FIG. 10B. Similarly, the probe 1440 may include the TLS sensor 162 incorporated therein.

[0119] FIGS. 15A-15C illustrate probe securing system 1500 according to some embodiments disclosed herein. FIG. 15A is a perspective view of the probe securing system 1500 including a probe 1540 that may in certain respects resemble the features and functionality of the probe 1340. FIG. 15B is a front view of the probe securing system 1500 and the probe 1540 in a ready -to-secure state, where the probe 1540 is disposed on the patient 70. FIG. 15C is a front view of the probe securing system 1500 and the probe 1540 in a secured state, where the probe 1540 and the probe securing system 1500 are secured to the patient 70. The probesecuring system 1500 includes a base defined by a first rail 1517 and second rail 1518 which are each configured for placement on the patient 70. In some embodiments, the first and second rails 1517, 1518 may include a patient securement mechanism 1512 (e.g., an adhesive layer) disposed on bottom sides 1517B, 1518B of the first and second rails 1517, 1518, where the patient securement mechanism 1512 is configured to attach the first and second rails 1517, 1518 to the skin surface 70A of the patient 70. In some embodiments, the first and second rails 1517, 1518 may be disposed parallel with each other, and in some embodiments, the probe 1540 may be disposed between the first and second rails 1517, 1518.

[0120] A frame member 1520 is coupled with the probe 1540. The frame member 1520 includes a link 1529 and first and second frame arms 1527, 1528 pivotably coupled with the link 1529 via first and second pivot points 1529A, 1529B, respectively. The link 1529 is rigidly attached to the probe 1540 via a probe attachment mechanism 1530, and first and second frame arms 1527, 1528 are coupled with the link 1529 to extend away from opposite lateral sides of the probe 1540. The first and second frame arms 1527, 1528 include a first and second feet 1537, 1538, respectively, where the first and second feet 1537, 1538 are coupled with the first and second rails 1517, 1518. The first and second feet 1537, 1538 may be fixedly attached to the first and second rails 1517, 1518 or in some embodiments, the first and second feet 1537, 1538 may slidably engage first and second slots 1517A, 1518A of the first and second rails 1517, 1518, respectively. In such embodiments, the first and second slots 1517A, 1518A are configured to allow the first and second feet 1537, 1538 to longitudinally displace along the first and second rails 1517, 1518 without allowing separation of the first and second feet 1537, 1538 from the first and second rails 1517, 1518.

[0121] The probe attachment mechanism 1530 is coupled between the link 1529 and the probe 1540. In some embodiments, the probe attachment mechanism 1530 may be configured for selective attachment to and detachment from the probe 1540, so that probe securing system 1500 may be separated from the probe 1540. Separation of the probe attachment mechanism 1530 may allow for cleaning of replacement of the probe securing system 1500. In other embodiments, the probe attachment mechanism 1530 may define a permanent attachment of the link 1529 to the probe 1540. In some embodiments, probe attachment mechanism 1530 is configured to couple the probe 1540 to the probe securing system 1500 such that a cable 1540B of the probe 1540 extends away from the probe 1540 in a direction that is parallel with the first and second rails 1517, 1518.

[0122] The first and second frame arms 1527, 1528 include a first arm first section 1527A and second arm first section 1528 A, respectively which are pivotably coupled with the link 1529 via the first and second pivot points 1529A, 1529B, respectively. The first and second frame arms 1527, 1528 further include a first arm second section 1527B and second arm second section 1528B, respectively coupled with the first arm first section 1527 A and second arm first section, 1528 A, via first and second bends 1527C, 1528C. In some embodiments, the first and second bends 1527C, 1528C may define angle that is approximately ninety degrees.

[0123] As shown in FIG. 15B, the first and second frame arms 1527, 1528 extend upward away from the probe 1540 in the ready -to-secure state. More specifically, the first arm first section 1527A and the second arm first section 1528 A may extend upward away from the probe in a substantially vertical direction, and the first arm first section 1527 A and second arm first section 1528 A may be disposed parallel with each other. Due to the first and second bends 1527C, 1528C, the first arm second section 1527B and second arm second section 1528B may extend laterally away from the probe 1540 in a substantially horizontal direction, and the first arm second section 1527B and the second arm second section 1528 A may be disposed in a linear relationship with each other.

[0124] As shown in FIG. 15C, the first and second frame arms 1527, 1528 extend laterally away from the probe 1540 in the secured state. The first arm first section 1527 A and the second arm first section 1528 A may extend laterally away from the probe 1540. Due to the first and second bends 1527C, 1528C, the first arm second section 1527B and second arm second section 1528B extend downward toward to the patient 70 so that the first and second rails 1517, 1518 may be disposed in contact with the patient 70, such as adhesively attached to the skin surface 70A via the patient securement mechanism 1512, for example. In the secured state, the probe 1540 may be disposed between the first arm second section 1527B and second arm second section 1528B.

[0125] The pivotal coupling of the first and second frame arms 1527, 1528 with the probe 1540 allow the probe securing system 1500 to accommodate non-flat contours of the patient 70, i.e., so that the bottom side 1540F of the probe 1540 can be disposed in contact with the patient 70 when the first and second rails 1517, 1518 are secured to the skin surface 70A. In some instances where the patient’s contour is substantially flat, the first arm first section 1527A and second arm first section 1528 A may extend away from the probe 1540 in a substantially horizontal direction, and the first arm first section 1527A and second arm firstsection 1528 A may be disposed in a linear relationship with each other. Similarly, the first arm second section 1527B and second arm second section 1528B may extend downward in a substantially vertical direction, and the first arm second section 1527B and the second arm second section 1528B may be disposed parallel with each other.

[0126] Although not required, the probe securing system 1500 may include a needle guiding mechanism 1560 having a needle guide 1565 (shown in block form via phantom lines) coupled with the probe 1540. The needle guiding mechanism 1560 having the needle guide 1565 may in certain respects resemble the needle guiding mechanism 1040 and the needle guide 1045 of FIG. 10B. Similarly, the probe 1540 may include the TLS sensor 162 incorporated therein.

[0127] FIGS. 16A, 16B illustrate probe securing system 1600 coupled with an ultrasound probe according to some embodiments disclosed herein. FIG. 16A is a front cross- sectional view of the probe securing system 1600 including an ultrasound probe (probe) 1640 in a positioning state, i.e., a state that allows a clinician to adjust the position the probe 1640 on the skin surface 70A of the patient 70 so as to be over a needle insertion site 70B. FIG. 16B is a front cross-sectional view of the probe securing system 1600 including the probe 1640 in a secured state, where the probe 1640 and the probe securing system 1600 are secured to the patient 70.

[0128] The probe 1640 defines a bottom side 1640F disposed against the skin surface 70A of the patient 70 so as to obtain an ultrasound image as described above. The probe 1640 further defines a top side 1640G opposite the bottom side 1640F. The probe 1640 includes an aperture 1643 having an inverted conical shape extending entirely through the probe 1640 from the top side 1640G to the bottom side 1640F, where the aperture defines a top opening 1643 A at the top side 1640G and a bottom opening 1643B at the bottom side 1640F.

[0129] The probe 1640 includes a detachable probe handle 1670 having a proximal handle portion 1670A and a distal conical portion 1670B. The distal conical portion 1670B to sized and shaped to match the aperture 1643, and the distal conical portion 1670B is disposed within the aperture 1643 such that a distal end 1670C of the distal conical portion 1670B essentially fills the bottom opening 1643B. In some embodiments, the 1670C may be disposed flush with the bottom side 1640F. The proximal handle portion 1670A extends away from thetop side 1640G. The detachable probe handle 1670 enables the clinician to manipulate the probe 1640 and adjust the position of the probe 1640 on the patient 70.

[0130] The probe securing system 1600 includes a frame 1620 that is configured to secure the probe 1640 to the patient after the clinician positions the probe 1640 such that the bottom opening 1643B is disposed at the insertion site 70B. The frame 1620 includes a perimeter portion 1620 A that extends around a circumferential perimeter of the probe 1640 such that lateral displacement of the probe 1640 with respect to the frame 1620 is substantially prevented. A top portion 1620B of the frame 1620 is coupled with the perimeter portion 1620A and extends at least partially across the top side 1640G to prevent upward displacement of the probe 1640 with respect to the frame 1620.

[0131] The probe securing system 1600 further includes a probe cover 1602 which defines a sterile barrier between the probe 1640 and the patient 70. The probe cover 1602 completely encapsulates the probe 1640 including the probe handle 1670. A handle portion 1602A of the probe cover 1602 extends over the proximal handle portion 1670A and opening portion 1602B extends across the bottom opening 1643B. The opening portion 1602B is secured (e.g., adhesively attached) to the distal end 1670C of the distal conical portion 1670B of the probe handle 1670. The opening portion 1602B is separable from the probe cover 1602, such as by way of a circumferential perforation or the like, for example. Similarly, the handle portion 1602A is separable from the probe cover 1602 by way of a circumferential perforation or the like, for example, extending around the top opening 1643 A. The probe cover 1602 and the frame 1620 may be attached to each other or integrally formed together.

[0132] Referring to FIG. 16B, the frame 1620 further includes a base portion 1610 (not shown in FIG. 16 A) coupled with the perimeter portion 1620 A, where the base portion 1610 includes an adhesive 1612 disposed along a bottom side thereof. The adhesive 1612 is configured to secure the base portion 1610 to the skin surface 70A thereby securing the probe 1640 to the patient 70. With the probe 1640 positioned over the insertion site 70B so that the bottom opening 1643B is disposed at the insertion site 70B, the probe 1640 may obtain a live ultrasound image of the patient 70 about the insertion site 70B with requiring the clinician to hold or manipulate the probe handle 1670.

[0133] After the probe 1640 is positioned such that the bottom opening 1643B is disposed at the insertion site 70B and after the base portion 1610 is secured to the skin surface70A, the clinician may detach and separatee the probe handle 1670 from the probe 1640, as illustrated in FIG. 16B. Upon separation of the probe handle 1670 from the probe 1640, the handle portion 1602 A and opening portion 1602B separate from the probe cover 1602 and remain with the probe handle 1670 thereby leaving the aperture 1643 open at the top side 1640G and the bottom side 1640F. With the aperture 1643 open at the top side 1640G and the bottom side 1640F, the aperture 1643 defines a pathway for the needle 165 (not shown in FIGS. 16A, 16B but see FIG. 1) to be inserted into the patient 70 at the insertion site 70B. The probe 1640 includes the TLS sensor 162 incorporated therein to enable guidance and tracking of the needle 165 as described above.

[0134] FIGS, 16C, 16D illustrate probe securing system 1601 that may in certain respects resemble the components, features and functionalities of the probe securing system 1600 of FIGS 16A, 16B. It will be appreciated that probe securing system 1601 may have analogous features to the probe securing system 1600. Accordingly, specific features of the probe securing system 1600 and related components shown in FIGS. 16 A, 16B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in FIGS. 16A, 16B and / or described with respect to FIGS. 16 A, 16B. Accordingly, the relevant descriptions of such features apply equally to the features of the probe securing system 11601 of FIGS. 16C, 16D. Any suitable combination of the features, and variations of the same, described with respect to the probe securing system 1600 and components illustrated in FIGS. 16A, 16B can be employed with the probe securing system 1601 and components of FIGS. 16C, 16D.

[0135] FIG. 16C illustrates the probe securing system 1601 including the probe 1640 in a positioning state, and FIG. 16D illustrates the probe securing system 1601 including the probe 1640 in a secured state as similarly illustrated in FIG. 16B. The frame 1620 is positionably coupled with the proximal handle portion 1670A of the probe handle 1670 so that the frame 1620 can be displaced from a probe positioning position 1623 A as shown in FIG. 16C and to probe securing position 1623B as shown in FIG. 16D. The frame 1620 may be coupled with the proximal handle portion 1670A such that displacement of the frame 1620 with respect to the proximal handle portion 1670A is prevented in the absence of a displacement force 1623C as applied by the clinician. For example, a friction 1623D between the frame 1620 and the proximal handle portion 1670A may prevent the frame 1620 fromsliding downward along the proximal handle portion 1670A in the absence of the displacement force 1623C. When the displacement force 1623C is applied to the fame 1620 by the clinician, the frame 1620 may displace from the probe positioning position 1623 A to the probe securing position 1623B. With the frame 1620 disposed is the probe securing position 1623B, the probe handle 1670 may be separated from the frame 1620 and the probe 1640.

[0136] FIGS. 17A-17C illustrate probe securing system 1700 coupled with an ultrasound probe 1740 according to some embodiments disclosed herein. The probe securing system 1700 may in certain respects resemble the components, features and functionalities of the probe securing system 1600 of FIGS 16A, 16B. FIG. 17A is a front cross-sectional view probe securing system 1700 including the ultrasound probe (probe) 1740 in a positioning state, i.e., a state that allows a clinician to adjust position the probe 1740 on the skin surface 70A of the patient 70 so as to be over a needle insertion site 70B. FIG. 17B is a front cross-sectional view probe securing system 1700 including the probe 1740 in a secured state, where the probe 1740 and the probe securing system 1700 are secured to the patient 70.

[0137] The probe 1740 defines a bottom side 1740F disposed against the skin surface 70A of the patient 70 so as to obtain an ultrasound image as described above. The probe 1740 further defines a top side 1740G opposite the bottom side 1740F. The probe 1740 includes an aperture 1743 having an inverted conical shape extending entirely through the probe 1740 from the top side 1740G to the bottom side 1740F, where the aperture defines a top opening 1743 A at the top side 1740G and a bottom opening 1743B at the bottom side 1740F.

[0138] The probe 1740 includes a detachable probe handle 1770 having a proximal handle portion 1770A and a distal conical portion 1770B. The distal conical portion 1770B is shaped and sized to match the aperture 1743 and the distal conical portion 1770B is disposed within the aperture 1743 such that a distal end 1770C of the distal conical portion 1770B essentially fills the bottom opening 1743B. In some embodiments, the distal end 1170C may be disposed flush with the bottom side 1740F. The proximal handle portion 1770A extends away from the top side 1740G. The detachable probe handle 1770 enables the clinician to manipulate the probe 1740 and adjust the position of the probe 1740 on the patient 70.

[0139] The probe securing system 1700 includes a probe cover 1702 which defines a sterile barrier between the probe 1740 and the patient 70. The probe cover 1702 is also configured to secure the probe 1740 to the patient 70 as described below. The probe cover 1702completely encapsulates the probe 1740 including the probe handle 1770. A handle portion 1702A of the probe cover 1702 extends over the proximal handle portion 1770A. The handle portion 1702A is separable from the probe cover 1702, such as by way of a circumferential perforation or the like, for example, extending around the top opening 1743 A. The probe cover 1702 extends across an entirety of the bottom side bottom side 1740F.

[0140] The probe cover 1702 is configured to secure the probe 1740 to the patient 70. The probe cover 1702 includes first adhesive 1712A disposed on an inside surface of the probe cover 1702 to be disposed between the probe cover 1702 and the bottom side 1740F of the probe 1740, thereby attaching the probe cover 1702 to the probe 1740 such that separation of the probe cover 1702 from the bottom side 1740F is prevented during use of the probe securing system 1700.

[0141] The probe cover 1702 further includes second adhesive 1712B disposed on an outside surface of the probe cover 1702 so as to be disposed between the probe cover 1702 and the patient 70. The second adhesive 1712B is configured to selectively secure the probe cover 1702 to the skin surface 70B of the patient 70. As FIG. 17A illustrates the probe securing system 1700 including an ultrasound probe (probe) 1740 in a positioning state, the second adhesive 1712B may be disposed in a deactivated state allowing slidable contact of the probe cover 1702 across the skin surface 70A. In some embodiments, the probe cover 1702 may include a peelable non-adhesive layer (not shown but see the non-adhesive layer 1012B of FIG. 10B) extending across the second adhesive 1712B to define the deactivated state of the second adhesive 1712B. The deactivated state of the second adhesive 1712B enables the clinician to position the probe 1740 over the insertion site 70B.

[0142] Referring to FIG. 17B, where the probe securing system 1700 is disposed in the securing state, the second adhesive is disposed in an activated state, thereby preventing (i) displacement of the probe 1740 across the skin surface 70A and (ii) separation of the probe 1740 from the patient 70. After the probe 1740 is positioned on and secured to the patient 70, the clinician may detach and separate the probe handle 1770 from the probe 1740, as illustrated in FIG. 17B. Upon separation of the probe handle 1770 from the probe 1740, the handle portion 1702A separates from the probe cover 1702 and remains with the probe handle 1770, thereby leaving the aperture 1743 open at the top side 1740G.

[0143] FIG. 17C is a bottom view of the probe securing system 1700 including the probe 1740. As shown, the probe cover 1702 extends across the entire bottom side 1740F of the probe 1740. The probe cover 1702 includes an adhesive free zone 1702B which may take the form a central strip extending across the bottom side 1740F including the bottom opening 1743B. The adhesive free zone 1702B is a portion of the probe cover 1702 that does not include the first adhesive 1712A or the second adhesive 1712B. The adhesive free zone 1702B which includes the portion of the probe cover 1702, is separable from the probe cover 1702. The adhesive free zone 1702B includes a pull tab 1702C that enables the clinician to separate the adhesive free zone 1702B from the probe cover 1702. In some embodiments, the probe cover 1702 may include tear-able sections (e.g., perforations) extending along opposite edges of the adhesive free zone 1702B that facilitate separation of the adhesive free zone 1702B from the probe cover 1702. During use, the clinician may exert a pulling force on the pull tab 1702 to separate the adhesive free zone 1702B for the probe cover 1702. In some embodiments, the probe cover 1702 is configured for removal of the adhesive free zone 1702B from the probe cover 1702 before securing the probe 1740 to the patient 70. In other embodiments, the probe cover 1702 is configured for removal of the adhesive free zone 1702B from the probe cover 1702 after securing the probe 1740 to the patient 70. Removable of the adhesive free zone 1702B leaves the aperture 1743 open at the top side 1740G of the probe 1740. With the aperture 1743 open at the top side 1740G and the bottom side 1740F, the aperture 1743 defines a pathway for the needle 165 (not shown in FIGS. 17A-17C but see FIG. 1) to be inserted into the patient 70 at the insertion site 70B. The probe 1740 includes the TLS sensor 162 incorporated therein to enable guidance and tracking of the needle 165 as described above.

[0144] FIGS. 18 A, 18B illustrate an ultrasound probe 1840 according to some embodiments disclosed herein. FIG. 18A is a bottom perspective view of ultrasound probe (probe) 1840. The probe 1840 includes a probe housing 1820 which defines a frame structure of the probe 1840. The probe housing 1820 defines a bottom side 1840F of the probe 1840 configured for placement on a skin surface of a patient 70 so as to obtain an ultrasound image as described above. A top side 1840G is disposed opposite the bottom side 1840F.

[0145] The probe 1840 includes an aperture 1843 extending entirely through the probe body 1820 from the top side 1840G to the bottom side 1840F. The aperture 1843 defines a pathway for the needle 165 (not shown in FIGS. 18 A, 18B but see FIG. 1) to be inserted into the patient 70 at the insertion site 70B (see for example FIGS. 16A, 16B). In someembodiments, the probe housing 1820 may be define circular shape surrounding the aperture 1843.

[0146] The probe 1840 includes a probe handle 1870 extending away from the housing 1820. The handle 1870 extends laterally away for the housing 1820 to define low profile of the probe 1840. In some embodiments, the probe handle 1870 may define a longitudinal axis that is substantially parallel with the bottom side 1840F so that during use the probe handle 1870 is disposed substantially parallel with the skin surface 70A of the patient 70.

[0147] FIG. 18B is a bottom view illustration of an arrangement of piezoelectric transducers surrounding the aperture 1843. In the illustrated embodiment, the arrangement includes a plurality of piezoelectric transducers 1883 dispersed across the bottom side 1840F. The arrangement further defines a plurality of linear arrays 1884, where each linear array 1884 includes a subset of the piezoelectric transducers 1883, and where each subset may include 1, 2, 3, 4 or more piezoelectric transducers. The linear arrays 1884 extend radially outward from the aperture 1843 similar to the spokes of wheel. The arrangement may include 3, 4, 5, or more linear arrays 1884. The piezoelectric transducers 1883 disposed in the arrangement described above are configured to enable acquisition of an ultrasound image of a cylindrical portion 70D of the patient 70 extending beneath the probe 1840, where the cylindrical portion 70D extends into the patient 70 from the skin surface 70A. In some embodiments, the cylindrical portion 70D may be disposed symmetrically around a longitudinal axis 1843C defined by the aperture 1843.

[0148] The probe further includes a TLS sensor 1862 that may in certain respects resemble the TLS sensor 162 described above. In some embodiments, the TLS sensor 1862 may include 2, 3, 4 or more magnetometers 1862A disposed in an array surrounding the aperture 1843. In some embodiments, the magnetometers 1862A may be disposed equidistant from the aperture 1843 and spaced at equal angles away from each other. The arrangement of the magnetometers 1862 A may enable 3 -dimension tracking of the needle 165 within the cylindrical portion 70D.

[0149] According to another embodiment of the probe 1840, FIG. 18D illustrates a bottom view of the probe 1840 further including a patient securement mechanism 1812. The patient securement mechanism 1812 includes a frame extension 1890 rotatably coupled with the housing 1820. In the illustrated embodiment, the frame extension 1891 may be generallylocated beneath the probe handle 1870. The frame extension 1890 includes a bottom surface 1891 A having an adhesive 1812A disposed thereon. The frame extension 1890 further includes a pair of arms 1893 A, 1892B rigidly coupled thereto. During use, the clinician may grasp and rotate the arms 1893 A, 1892B to rotate the frame extension 1890 with respect to the body 1820.

[0150] FIGS. 18E and 18F are each a right-side view illustration of a portion of the probe 1840 and the patient securement mechanism 1812 disposed on the skin surface 70A of the patient 70. FIG. 18E shows the patient securement mechanism 1812 transitioned to a positioning state, where the frame extension 1890 is rotated away from the skin surface 70A via a pivot point 1892 so that the adhesive 1812A is not in contact with the skin surface 70A. In the positioning state, the clinician may adjust the position of the probe 1840 on the patient 70.

[0151] FIG. 18F shows the patient securement mechanism 1812 transitioned to a securing state, where the frame extension 1890 is rotated toward the skin surface 70A via a pivot point 1892 so that the adhesive 1812A engages the skin surface 70A. In the securing state, the probe 1840 is secured to the patient 70 so that the clinician does not need to hold the probe 1840 in the secured position.

[0152] FIG. 18G illustrates another embodiment of an ultrasound probe that includes the patient securement mechanism 1812. The probe 1841 includes the components, features, and functionalities of the probe 1840 including the patient securement mechanism 1812 except that the probe handle 1870 is omitted from the probe 1841. During use, the clinician may grasp the housing 1820 to adjust the location of the probe 1841 on the patient.

[0153] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A needle guidance system, comprising: a patient anatomy imaging system, including an x-ray imaging system or an ultrasound guidance system (UGS), the UGS comprising: an ultrasound probe having piezoelectric array configured for producing ultrasonic pulses and receiving ultrasonic echoes thereof after reflection by anatomic elements within a target area of a patient; and a UGS console operatively coupled with the ultrasound probe, the UGS console including a UGS processor and UGS memory having UGS logic stored thereon that, when executed by the UGS processor, performs UGS operations that include processing echo data to determine an ultrasound image of the target area and depicting the ultrasound image on a display of the UGS; and a tip location system (TLS) communicatively coupled with the UGS, the TLS comprising: a needle having a magnetic element disposed at a distal tip thereof, the magnetic element configured to define a magnetic field; and a TLS sensor configured for placement on the patent at the target area, the TLS sensor having a number of magnetic sensors configured to detect the magnetic field and a TLS console coupled with the magnetic sensors, the TLS console including a TLS processor and TLS memory having TLS logic stored thereon that, when executed by the TLS processor, performs TLS operations that include processing magnetic field data to track a location of the distal tip with respect to the TLS sensor and communicating the location of the distal tip to the UGS, wherein the UGS operations further include receiving the location of the distal tip from the TLS and overlaying a live distal tip image atop the ultrasound image in accordance with the location of the distal tip.

2. The system according to claim 1, wherein the TLS operations further include determining a depth of the distal tip with respect to the TLS sensor and the UGS operations further include depicting the depth of the distal tip on the display.

3. The system according to claim 1 or claim 2, wherein: the target area includes an epidural / spinal space of the patient, and overlaying the live distal tip image includes depicting the live distal tip image with respect to the epidural / spinal space in accordance with the location of the distal tip.

4. The system according to claim 3, wherein the UGS operations further include identifying the epidural / spinal space within the ultrasound image.

5. The system according to claim 4, wherein the UGS operations further include determining a depth of the epidural / spinal space with respect to the skin surface and depicting the depth of the epidural / spinal space on the display.

6. The system according to claim 5, wherein the UGS operations further include providing a notification to the clinician when the depth of the distal tip is equal to the depth of the epidural / spinal space within a defined tolerance stored in the UGS memory.

7. The system according to any one of claims 4-6, wherein the UGS operations further include defining, from the ultrasound image, a needle pathway extending toward the epidural / spinal space and overlaying a needle pathway image atop the ultrasound image.

8. The system according to claim 7, wherein the UGS operations further include: freezing the ultrasound image on the display, and overlaying the live distal tip image atop the frozen ultrasound image.

9. The system according to claim 8, wherein the UGS operations further include overlaying a needle pathway image atop the frozen ultrasound image.

10. The system according to claim 9, wherein: the needle pathway extends to and intersects the skin surface within the frozen ultrasound image to define a UGS baseline location on the ultrasound image, the TLS operations further include recording the location of the distal tip when the distal tip is positioned at a needle insertion site on the skin surface of thepatient to define a TLS baseline location and communicating the TLS baseline location to the UGS, and the UGS operations further include digitally collocating the UGS baseline location and the TLS baseline location to correlate the ultrasound image to the location of the TLS sensor on the skin surface of the patient so that when the distal tip of the needle is positioned at the needle insertion site, the live distal tip image is depicted atop the needle pathway image at the intersection of the needle pathway with the skin surface within the frozen ultrasound image.

11. The system according to any one of the preceding claims, further comprising a probe securing apparatus configured to secure the ultrasound probe to the patient to prevent movement of the ultrasound probe with respect to the patient while determining the ultrasound image of the target area.

12. The system according to claim 11, wherein the probe securing apparatus is: attached to the ultrasound probe, and configured to attach to a skin surface of the patient adjacent the insertion site.

13. The system according to claim 12, wherein a base of the probe securing apparatus includes an adhesive for attaching the probe securing apparatus to the skin surface.

14. The system according to either claim 12 or 13, wherein the probe securing apparatus includes a probe cover that defines a sterile barrier between the ultrasound probe and the patient.

15. The system according to claim 14, wherein the probe securing apparatus is attached to the ultrasound probe across the probe cover.

16. The system according to any one of claims 11-15, wherein the probe securing apparatus includes a needle guide coupled therewith, the needle guide configured to define a lateral position and an orientation of the needle with respect to the probe securing apparatus.

17. The system according to any one of the preceding claims, wherein the TLS sensor is wirelessly coupled with the UGS console.

18. The system according to any one of the preceding claims, wherein the TLS sensor includes an adhesive layer disposed along a bottom side of a housing of the TLS sensor, the adhesive layer configured to adhesively secure the TLS sensor to a skin surface of the patient.

19. The system according to any one of claims 11-17, wherein the TLS sensor is physically attached to the probe securing apparatus.

20. The system according to any one of claims 1-16, wherein the TLS sensor is incorporated into the ultrasound probe.

21. The system according to any one of the preceding claims, wherein needle includes a magnesite material.

22. A method, comprising: projecting, via an ultrasound probe of an ultrasound guidance system (UGS), ultrasound pules into a target area of a patient; receiving, by the ultrasound probe, ultrasound echoes reflected off anatomic elements within the target area; converting the ultrasound echoes into electronic signals and further converting the electronic signals into ultrasound image data via electrical components of a UGS console of the UGS; processing, according to UGS logic the UGS console, the ultrasound image data to define an ultrasound image of the target area; depicting the ultrasound image on a display of the UGS; identifying an epidural / spinal space within the ultrasound image; detecting, by a tip location system (TLS) sensor attached to a skin surface of patient at the target area, a magnetic field defined by a magnetic element coupled with a needle at a distal tip of the needle, the needle inserted into the target area; converting electrical signals based on the magnetic field into tip location data via electrical components of a TLS console of the TLS; processing, according to logic of the TLS console, the tip location data to track a location of the distal tip with respect the TLS sensor; andoverlaying a live distal tip image atop the ultrasound image in accordance with the location of the distal tip.

23. The method according to claim 22, wherein identifying an epidural / spinal space includes processing the ultrasound image data according to the UGS logic to automatically identify the epidural / spinal space.

24. The method according to either claim 22 or 23, further comprising: processing the ultrasound image data according to the UGS logic to determine a depth of the epidural / spinal space with respect to the skin surface; and depicting the depth of the epidural / spinal space on the display.

25. The method according to any one of claims 22-24, further comprising: processing the tip location data, according to the TLS logic, to determine a depth of the distal tip with respect to the TLS sensor; and depicting the depth of the distal tip on the display.

26. The method according to claim 25, further comprising: providing a notification to the clinician when the depth of the distal tip is equal to the depth of the epidural / spinal space within a defined tolerance defined by the UGS logic.

27. The method according to any one of claims 22-26, wherein TLS sensor includes an adhesive layer disposed along a bottom side of a housing of the TLS sensor, the adhesive layer configured to adhesively secure the TLS sensor to the skin surface.

28. The method according to any one of claims 22-27, wherein TLS sensor is wirelessly coupled with the UGS console.

29. The method according to any one of claims 22-28, wherein: the UGS includes a probe securing apparatus configured to secure the ultrasound probe to the patient to prevent movement of the ultrasound probe with respect to the patient, and projecting, via an ultrasound probe of an ultrasound guidance system (UGS), ultrasound pules into a target area of a patient is performed with the ultrasound probe secured to the patient via the probe securing apparatus.

30. The method according to any one of claims 22-29, further including freezing the ultrasound image on the display to define a frozen ultrasound image.

31. The method according to claim 30, wherein overlaying the live distal tip image atop the ultrasound image includes overlaying the live distal tip image atop the frozen ultrasound image.

32. The method according to either claim 30 or 31, further comprising: processing the ultrasound image data, according to the UGS logic, to define a needle pathway extending toward the epidural / spinal space; and overlaying a needle pathway image atop the frozen ultrasound image.