SYSTEM AND METHOD FOR ULTRASOUND PROBE NEEDLE TRACKING STATUS INDICATOR - Patent application

Abstract

A guidance system uses ultrasound imaging or other suitable imaging technology to guide the insertion of a needle into a patient's body. The guidance system may include an imaging device including a probe for generating an image of a target within the body, such as a blood vessel. The imaging device may be configured to provide at least one indication of status via sensory feedback, e.g., via multiple light-emitting diodes located on the device, based on the determined position of the needle. One or more sensors may be included in the probe and may be capable of sensing a magnetic field associated with the needle. The system may include a processor capable of receiving magnetic field data sensed by the at least one sensor to determine the position of the needle. The system may also include a display representing the determined position of the needle.

Description

[Technical field]

[0001] A system and method for an ultrasound probe needle tracking status indicator. [Background technology]

[0002] Medical device tracking and guidance is described in the context of various instruments, such as catheters, stylets, and needles, in the following U.S. patents: US Pat. Nos. 5,633,613; 5,793,336; 5,893,292; and 5,943,963, each of which is incorporated by reference in its entirety herein: [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Pat. No. 9,649,048 [Patent Document 2] U.S. Patent No. 9,636,031 [Patent Document 3] U.S. Pat. No. 9,554,716 [Patent Document 4] U.S. Patent No. 9,521,961 [Patent Document 5] U.S. Patent No. 9,492,097 [Patent Document 6] U.S. Pat. No. 9,456,766 [Patent Document 7] U.S. Patent No. 8,849,382 [Patent Document 8] U.S. Patent No. 8,781,555 [Patent Document 9] U.S. Patent No. 8,388,541 [Patent Document 10] U.S. Pat. No. 1,075,1509 [Patent Document 11] U.S. Pat. No. 1,044,930 [Patent Document 12] U.S. Pat. No. 10,524,691 Summary of the Invention [Problem to be solved by the invention]

[0004] However, there is a continuing need for improvements in guides for medical instruments, including the human interface between the guide system and the medical instruments that are guided thereby. Disclosed herein are guide systems, medical instruments, and methods that address the above-mentioned need for improved guides for medical instruments. [Means for solving the problem]

[0005] Briefly summarized, embodiments described herein relate to an integrated catheter placement system and method for accurately placing a catheter within a patient's vasculature with a set of integrated status indication systems and methods. The integrated system may, for example, use at least three modalities to enhance accuracy of catheter placement: 1) ultrasound-assisted guidance for introducing the catheter into the patient's vasculature; 2) a tip location system ("TLS"), i.e., magnetic-based (e.g., by one or more permanent magnets or one or more electromagnets) tracking of the catheter tip as it advances through the vasculature to facilitate detection and correction of any improper tip position during such advancement; and 3) status indicators that enable a clinician to improve needle tracking and guidance by providing information regarding motion calibration and / or suggested direction based on the tracking.

[0006] In one embodiment, a guide system for guiding insertion of a needle into a patient's body includes an ultrasound imaging device including a probe for ultrasonically imaging a target in an internal body portion. At least one sensor included in the probe senses a magnetic field associated with the needle, and a processor receiving the magnetic field data sensed by the sensor determines a position of the needle in three-dimensional space. A display further represents the determined position of the needle together with an image of the target, and the ultrasound imaging device is also configured to provide at least one indication of a status by sensory feedback based on the determined position.

[0007] In other embodiments, the sensory feedback is delivered by visible light, which may include visible light generated by a number of light emitting diodes located on the probe or monitor, which may be configured to emit a first series of light patterns to indicate at least one status associated with calibration of a component of the guidance system and / or a second series of light patterns to indicate a proposed direction for moving the probe to improve tracking accuracy.

[0008] In additional embodiments, the light patterns may include using colors to indicate the status of the system, including the proposed direction for moving the needle and / or probe. Specifically, in some embodiments, a change between at least two colors is associated with the proposed direction of movement.

[0009] Further, embodiments may include at least two light emitting diodes positioned on opposite sides of the probe, and a change between at least two of the colors of the second series of light patterns is associated with the suggested direction. These light emitting diodes may be in a variety of shapes, including two-way and three-way arrows, such that changes in light color or intensity may result in various levels of status indication.

[0010] In many embodiments, the sensory feedback is delivered by a visual indicator on a display. This can often be accomplished by the display. In particular, the display can be configured to emit a first color pattern to indicate at least one status associated with calibration of a component of the guidance system, a second color pattern to indicate at least one error in the guidance system, and / or a third color pattern to indicate a ready or fault condition in the guidance system.

[0011] In some embodiments, sensory feedback may be provided by a wearable device. The wearable device may deliver visual sensory feedback (e.g., visual images) by a smart glasses system. Other wearable devices may provide tactile feedback, such as vibration sensors in a smart watch or other suitable physical contact device that communicates with the guidance system. In further embodiments, sensory feedback may be provided by tactile vibrations generated in the probe.

[0012] In one embodiment, the sensory feedback is provided by an audible signal generated to be heard by the clinician. The audible tones may be generated on the display and / or within the probe, with multiple tones to indicate multiple statuses.

[0013] In another embodiment, a guide system for guiding insertion of a needle into a patient's body includes an ultrasound imaging device including a probe for ultrasonically imaging a target in an internal body portion within a calibration zone determined by a calibration process. At least one sensor included in the probe senses a magnetic field associated with the needle, and a processor receiving the magnetic field data sensed by the sensor determines a position of the needle in three-dimensional space within the calibration zone. A display further represents the determined position of the needle together with an image of the target, and the ultrasound imaging device is also configured to provide at least one indication of a status by sensory feedback from a plurality of light emitting diodes disposed on the probe. The sensory feedback includes generating a visual notification that the probe is being moved near a boundary of the calibration zone.

[0014] In one embodiment, a method is for guiding a needle for insertion into a patient's body using imaging techniques, the method including: (a) imaging a target within the body, (b) sensing a detectable feature related to the needle with a probe, (c) determining a position of the needle in at least two dimensional space with data related to the sensed detectable feature and the sensed degree of bending, (d) displaying the position of the needle relative to the target together with an image of the target, and (e) providing at least one indication of a status by sensory feedback based on the determined position.

[0015] In some embodiments, the sensory feedback is delivered by visible light. In some embodiments, the visible light is generated by a number of light emitting diodes located on the probe.

[0016] In some embodiments, the plurality of light emitting diodes are configured to emit a first series of light patterns to indicate at least one status associated with calibration of a component of the guide system.

[0017] In some embodiments, the plurality of light emitting diodes are configured to emit a second series of light patterns to indicate a proposed direction for moving the probe to enhance tracking accuracy.

[0018] In some embodiments, the second series of light patterns includes using multiple colors to indicate the proposed direction. In some embodiments, a change between at least two of the multiple colors is associated with the proposed direction.

[0019] In some embodiments, at least two of the plurality of light emitting diodes are positioned on opposite sides of the probe, and a change between at least two of the plurality of colors of the second series of light patterns is associated with the proposed direction.

[0020] In some embodiments, the sensory feedback is delivered by a visual indicator on the display. In some embodiments, the displaying further comprises illuminating a first color pattern to indicate at least one status associated with the calibration status of the at least one component.

[0021] In some embodiments, the indicating further comprises illuminating a second color pattern to indicate the at least one error. In some embodiments, the indicating further comprises emitting a third color pattern to indicate the ready state.

[0022] In some embodiments, the sensory feedback is delivered by a visual image generated by a wearable device. In some embodiments, the sensory feedback is delivered by tactile feedback generated within the probe.

[0023] In some embodiments, providing sensory feedback further comprises delivering an audible signal via a speaker. These and other features of the embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter.

[0024] A more detailed description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It will be appreciated that these drawings only depict typical embodiments of the invention and are therefore not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with further specificity and detail using the accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is a block diagram illustrating various elements of an ultrasound-based guidance system for needles and other medical components, according to one exemplary embodiment of the present invention. [Diagram 2] 2 is a schematic diagram of a patient and a catheter inserted within the patient, illustrating one possible environment in which the guide system of FIG. 1 may be implemented. [Diagram 3] FIG. 2 is a top view of an ultrasound probe of the guide system of FIG. 1. [Figure 4A] 2 is a side view of a needle for use with the guide system of FIG. 1 according to one embodiment. [Figure 4B] FIG. 4B is an end view of the needle of FIG. 4A. [Figure 5A] 1 is a schematic diagram of an ultrasound probe of a guidance system being used to guide a needle toward a blood vessel within a patient's body. [Figure 5B] 1 is another schematic diagram of an ultrasound probe of a guidance system being used to guide a needle toward a blood vessel within a patient's body. [Figure 6A] 13A-13C show possible screenshots for representation on a display of a guide system showing needle position and orientation, according to one embodiment. [Figure 6B] 13 shows another possible screenshot for presentation on the display of the guide system showing needle position and orientation, according to one embodiment. [Figure 7A] 13 illustrates a possible configuration of indicator lights located on top of the probe of the guide system, positioned at both ends, and shaped like a double-headed arrow, according to one embodiment. [Figure 7B] 7B shows the light emitting diode of FIG. 7A in an "on" state. [Figure 7C] 13 illustrates another possible configuration of light emitting diodes located on top of a probe of a guide system, arranged at both ends, and shaped in the form of a double-headed arrow, according to one embodiment. [Figure 7D] 13 illustrates a possible configuration of light emitting diodes located on top of a probe of a guide system, arranged at both ends, and shaped in the form of a three-headed arrow, according to one embodiment. [Figure 8A] 13 illustrates a possible configuration of light emitting diodes located on the front side of a probe of a guide system, arranged at both ends, and shaped in the form of a double-headed arrow, according to one embodiment. [Figure 8B] 8B shows the light emitting diode of FIG. 8A in an "on" state. [Figure 9A] 13 illustrates a possible screenshot for rendering on a display of the guidance system, showing a colored status indication border around the ultrasound viewing area and associated icons, according to one embodiment. [Figure 9B] 13 illustrates another possible screenshot for rendering on a display of the guidance system, showing a colored status indication border around the ultrasound viewing area and associated icons, according to one embodiment. [Figure 9C] 13 illustrates yet another possible screenshot for rendering on a display of the guidance system, showing a colored status indication border around the ultrasound viewing area and associated icons, according to one embodiment. [Figure 9D]13 illustrates yet another possible screenshot for rendering on a display of the guidance system, showing a colored status indication border around the ultrasound viewing area and associated icons, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Before disclosing some specific embodiments in detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that the specific embodiments disclosed herein may have multiple features that can be easily separated from the specific embodiment and, optionally, can be combined or substituted with the features of any of the several other embodiments disclosed herein.

[0027] Referring now to the drawings, in which like structures are provided with like reference numerals, it is understood that the drawings are diagrammatic and schematic illustrations of exemplary embodiments of the invention and are neither limiting nor necessarily to scale.

[0028] With regard to the terms used herein, it should also be understood that the terms are for the purpose of describing some particular embodiments, and that the terms do not limit the scope of the concepts brought forth 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 imply sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back", etc. are used for convenience and do not, for example, imply any particular fixed location, orientation, or direction. Instead, such labels are used, for example, to reflect relative locations, orientations, or directions. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0029] With respect to "proximal," for example, a "proximal portion" or "proximal length" of a catheter disclosed herein includes a portion of the catheter that is intended to be near the clinician when the catheter is in use on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be near the clinician when the catheter is in use on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is in use on a patient. A proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter. However, a proximal portion, proximal portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, a proximal portion, proximal portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0030] With respect to the "tip," for example, a "tip portion" or "tip length" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, a "tip length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is in use with the patient. For example, the "tip" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is in use with the patient. A tip portion, tip portion, or tip length of a catheter may include the tip of the catheter. However, a tip portion, tip portion, or tip length of a catheter need not include the tip of the catheter. That is, unless the context suggests otherwise, a tip portion, tip portion, or tip length of a catheter is not a terminal portion or terminal length of a catheter.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As noted above, there is a continuing need for improved guides for medical instruments, including human interfaces between the guide system and the medical instruments guided thereby. Disclosed herein are guide systems, medical instruments, and methods that address the above-mentioned need for improved guides for medical instruments.

[0032] The embodiments of the invention described herein generally relate to status indicators for a guide system configured to locate and guide a needle or other medical component during an ultrasound-based procedure or other suitable procedure, for example to access a subcutaneous blood vessel of a patient with a needle. In many embodiments, the status indicators facilitate a user of the guide system to position, orient, and advance the needle in real time, thereby enabling the clinician to better guide the needle to the intended target with precision. In some embodiments, the guide system can track the needle position in five degrees of freedom of motion, namely, x, y, and z spatial coordinate space, needle pitch, and needle yaw. Some status indicators can be configured to inform the user of the guide system on how to better orient the needle position within these degrees of freedom of motion. Such tracking and feedback systems can enable the needle to be guided and placed with relatively greater precision than a guide system without such status indicators.

[0033] Reference is initially made to Figures 1 and 2, which illustrate various components of an ultrasound-based needle guidance system ("system"), generally designated 10, configured in accordance with one embodiment of the present invention. As illustrated, guidance system 10 generally includes an ultrasound ("US") imaging portion including a console 20, a display 30, and a handheld ultrasound probe 40, each of which is described in detail below. It should be noted that the ultrasound imaging portion may be configured in one of a variety of ways in addition to that illustrated and described herein.

[0034] It will be appreciated that the console 20 may take one of a variety of forms. A processor 22, including non-volatile memory, such as EEPROM, is included in the console 20 for controlling system functions during operation of the guidance system 10, thereby performing the functions of a control processor. A digital controller / analog interface 24 may also be included in the console 20 and communicates with the processor 22 and other system components to manage the interface between the ultrasound probe 40 and the other system components.

[0035] The guide system 10 may further include a number of ports 52 for connecting with optional components 54 including a printer, storage media, keyboard, etc. In one embodiment, the ports are USB ports, although other port types or combinations of port types may be used for this and other interface connections described herein. In some embodiments, the ports 52 may be powered by a wireless connection over a network. A power connection 56 is included in the console 20 to allow for operative connection with an external power supply 58. An internal power supply 60 (e.g., a battery) may also be used, either with or without the external power supply. A power management circuit 59 is included in the digital controller / analog interface 24 of the console to regulate power utilization and distribution.

[0036] The display 30 in this embodiment is a single display integrated into the console 20 and used to display information to the clinician during the procedure. In another embodiment, the display may be separate from the console. It will be appreciated that the content depicted by the display 30 may change according to which mode the system is in, such as, but not limited to, US, TLS, or in other embodiments, ECG tip confirmation. In some embodiments, the console button interface 32 and buttons included on the ultrasound probe 40 may be used by the clinician to quickly call up the desired mode on the display 30 to assist in the procedure. In additional embodiments, information from multiple modes, such as TLS and ECG, may be displayed simultaneously. Thus, the display 30 of the console 20 may be used for ultrasound guidance in accessing the patient's vasculature, TLS guidance during catheter advancement through the vasculature, and ECG-based confirmation of catheter tip placement with respect to the patient's cardiac nodes (as in the embodiments described below). In further embodiments, the ultrasound probe 40 may include a number of control buttons 84 (see FIG. 2) that may be used by the clinician to quickly invoke a desired mode on the display 30 to assist in the placement procedure. In many embodiments, the display 30 employs an LCD panel.

[0037] The ultrasound probe 40 may be used in conjunction with the modalities described above, i.e., ultrasound ("US")-based visualization of blood vessels, such as veins, in preparation for insertion of the catheter 72 (see FIG. 2) into the vasculature. Such visualization may provide real-time ultrasound guidance for the introduction of the catheter 72 into the vasculature of the patient 70 and help reduce complications commonly associated with such introduction, such as inadvertent arterial puncture, hematoma, pneumothorax, etc.

[0038] 1 further illustrates that the ultrasound probe 40 may further include a button and memory controller 42 for managing buttons and probe operation. The button and memory controller 42 may include non-volatile memory, such as an EEPROM, in some embodiments. The button and memory controller 42 is in operative communication with a probe interface 44 of the console 20, which often includes a piezo input / output component 44A for interfacing with the probe piezoelectric array, and a button and memory input / output component 44B for interfacing with the button and memory controller 42.

[0039] The ultrasound imaging portion of the guide system 10 may also be used to image a targeted internal portion of a patient's body prior to percutaneous insertion of a needle or other device to access the target. As described below, in some embodiments, needle insertion is performed prior to subsequent catheter insertion into a vein or other portion of the patient's vasculature. However, it will be recognized that needle insertion into a patient's body may be performed for a variety of medical purposes.

[0040] FIG. 2 illustrates the general relationship of the above-mentioned components to a patient 70 during a procedure for final placement of a catheter 72 through the skin at an insertion site 73 into the patient's vasculature, according to one embodiment. FIG. 2 illustrates that the catheter 72 generally includes a proximal portion 74 that remains outside the patient, and a distal portion 76 that resides within the patient's vasculature after placement is complete. The guide system 10 is used to ultimately position the distal tip 76A of the catheter 72 at a desired location within the patient's vasculature. In one embodiment, the desired location for the distal tip 76A of the catheter 72 is in close proximity to the patient's heart, for example, in the lower third of the superior vena cava ("SVC"). Of course, the guide system 10 may be used to place the catheter distal tip at other locations.

[0041] The proximal portion 74 of the catheter 72 further includes a hub 74A that provides fluid communication between one or more lumens of the catheter 72, and one or more extension legs 74B extending proximally from the hub. As discussed above, placement of the needle 100 within the patient's vasculature at the insertion site 73 is typically performed prior to insertion of the catheter, although it is recognized that other placement techniques may be used. Furthermore, it is recognized that the above description is only one example of a use of the guide system 10. Indeed, it may be used for a variety of uses, such as placement of a needle in preparation for insertion of a catheter as discussed above, insertion of the needle 100 for other uses, or insertion of other medical components into the patient's body, including x-ray or ultrasound markers, biopsy sheaths, ablation components, bladder scanning components, vena cava filters, and the like.

[0042] In particular, a console 20 houses the various components of the guidance system 10, it being recognized that the console may take one of a variety of forms. A processor 22, including non-volatile memory such as, for example, an EEPROM, is included within the console 20 for controlling system functions and executing various algorithms during operation of the guidance system 10, thereby performing the functions of a control processor. A digital controller / analog interface 24 is also included in the console 20 to communicate with the processor 22 and other system components and to manage the interface between the ultrasound probe 40 and the other system components.

[0043] 2 also depicts a needle 100 that is used to initially access the patient's vasculature via insertion site 73. As described in more detail below, needle 100 is configured to cooperate with guide system 10 to enable the system to detect the position, orientation, and advancement of the needle during an ultrasound-based placement procedure.

[0044] 3 depicts features of an ultrasound probe 40 according to various embodiments. The ultrasound probe 40 is used in conjunction with ultrasound-based visualization of blood vessels, such as veins, in preparation for insertion of a needle 100 and / or catheter 72 into the vasculature. Such visualization can provide real-time ultrasound guidance and helps reduce complications commonly associated with such introductions, such as inadvertent arterial puncture, hematoma, pneumothorax, etc.

[0045] The ultrasonic probe 40 is often configured to include a head 80 that houses a piezoelectric (or similarly functional) array for producing ultrasonic pulses and receiving echoes after reflection by the patient's body when the head is placed against the patient's skin in close proximity to the anticipated insertion site 73 (FIG. 2). The ultrasonic probe 40 also includes control buttons 84 (FIG. 2) for controlling the system, thereby eliminating the need for the clinician to reach into a sterile field established around the patient's insertion site prior to establishment of the insertion site in order to control the guide system 10.

[0046] As such, in one embodiment, the clinician uses the ultrasound imaging portion of the guide system 10 to determine a suitable insertion site and establish vascular access, such as with a needle 100, prior to introduction of the catheter 72, and ultimately advancing it through the vasculature toward its intended destination.

[0047] As seen in FIG. 3, the ultrasound probe 40 may include a sensor array 90 to detect the position, orientation, and movement of the needle 100 during an ultrasound imaging procedure such as that described above. As described in more detail below, the sensor array includes a plurality of magnetic sensors 92 embedded in the housing of the probe. The magnetic sensors 92 are configured to detect a magnetic field associated with the needle 100 and enable the guide system 10 to track the needle. Although configured here as a magnetic sensor, it will be appreciated that the magnetic sensors 92 may be other types and forms of sensors as will be described. Additionally, although the magnetic sensors are shown in FIG. 3 as being included in the ultrasound probe 40, the magnetic sensors 92 of the sensor array 90 may be included in a component separate from the probe, such as a separate handheld device. Such a device may be used, for example, to incorporate other probes into a similar device without the magnetic sensors 92. In this embodiment, the magnetic sensors 92 are disposed in a planar configuration below the top surface 82 of the ultrasound probe 40, although it will be appreciated that the sensors may be disposed in other configurations, such as an arched or semicircular arrangement.

[0048] In the embodiment shown in FIG. 3, the magnetic sensors 92 each include three orthogonal sensor coils to enable detection of magnetic fields in three-dimensional space. Such three-dimensional ("3D") magnetic sensors can be purchased, for example, from Honeywell Sensing and Control (Morristown, NJ). Additionally, although the magnetic sensors 92 in this embodiment are configured as Hall effect sensors, other types of magnetic sensors may also be used. Additionally, instead of a 3D sensor, multiple one-dimensional magnetic sensors may be included and arranged as desired to achieve 1D, 2D, or 3D detection capabilities.

[0049] In this embodiment, the magnetic sensor 92 includes five magnetic sensors in the sensor array 90 to enable not only detection of the needle 100 in three-dimensional space (i.e., X, Y, Z coordinate space), but also detection of the pitch and yaw orientation of the needle itself. It is noted that in one embodiment, two or more orthogonal sensing components of the magnetic sensor 92 may enable the pitch and yaw attitude of the magnetic element 110, and thus of the needle 100, to be determined.

[0050] In other embodiments, fewer or more sensors may be used by the sensor array, depending on the application. More generally, it will be recognized that the number, size, type, and arrangement of sensors in a sensor array may differ from those set forth herein.

[0051] 4A and 4B show details of one example of a needle 100 that may be used in conjunction with the guide system 10, as shown in FIG. 2, to access a targeted internal portion of a patient, according to one embodiment. In particular, the needle 100 includes a hollow cannula 102 having a proximal end 102A and a distal end 102B. A hub 104 is attached to the proximal end 102A of the cannula 102 and includes an open end 104A that, in this embodiment, is configured as a connector for connecting to various devices. Indeed, the open end 104A of the hub 104 is in fluid communication with the lumen of the cannula 102, such that a guidewire, stylet, or other component may be passed through the hub and into the cannula.

[0052] As shown in Figures 4A and 4B, the magnetic element 110 is included in the hub 104. As best shown in Figure 4B, in this embodiment, the magnetic element 110 is a permanent magnet, for example comprising a ferromagnetic material, and is ring-shaped to define a hole 112 that is aligned with the cannula 102. So configured, the magnetic element 110 generates a magnetic field that is detectable by the sensor array 90 of the ultrasound probe 40, allowing the location, orientation, and movement of the needle 100 to be tracked by the guide system 10, as described further below.

[0053] It will be appreciated that in other embodiments, many other types, numbers, and sizes of magnetic elements may be used in conjunction with the needle 100 or other medical component to enable its tracking by the present guide system.

[0054] 5A and 5B, these figures show the ultrasound probe 40 and needle 100 of the guide system 10 in place and ready to be inserted through a patient's skin surface 120 to access a targeted internal body portion. In particular, the ultrasound probe 40 is shown with the head 80 placed against the patient's skin and generating an ultrasound beam 122 to ultrasonically image a portion of a subcutaneous blood vessel 126 below the patient's skin surface 120. An ultrasound image of the blood vessel 126 may be rendered on the display 30 (FIG. 2) of the guide system 10.

[0055] As mentioned above, in this embodiment, the guide system 10 is configured to detect the position, orientation, and movement of the needle 100 described above. In particular, the sensor array 90 of the ultrasound probe 40 is configured to detect the magnetic field associated with the magnetic element 110 included in the needle 100. Each of the magnetic sensors 92 of the sensor array 90 is configured to spatially detect the magnetic element 110 in three-dimensional space. Thus, during operation of the guide system 10, the magnetic field strength data of the magnetic element 110 associated with the needle sensed by each of the magnetic sensors 92 is transferred to a processor, such as the processor 22 of the console 20 (FIG. 1), which calculates the position and / or orientation of the magnetic element 110 in real time. In some embodiments, the needle may be made of a magnetic material such that the magnetic element 110 is not required for detection by the sensor array 90 of the ultrasound probe 40.

[0056] Specifically, as shown in Figures 5A and 5B, the position of the magnetic element 110 in X, Y, and Z coordinate space relative to the sensor array 90 can be determined by the guide system 10 using magnetic field strength data sensed by the magnetic sensor 92. Additionally, Figure 5A shows that the pitch of the magnetic element 110 can also be determined, while Figure 5B shows that the yaw of the magnetic element can be determined. Suitable circuitry in the ultrasound probe 40, console 20, or other components of the system can perform the necessary calculations for such position / orientation. In one embodiment, the magnetic element 110 can be tracked using the teachings of one or more of U.S. Patent Nos. 5,775,322, 5,879,297, 6,129,668, 6,216,028, and 6,263,230, each of which is incorporated herein by reference in its entirety.

[0057] The above position and orientation information determined by the guide system 10, together with the length of the cannula 102 and the position of the magnetic element 110 relative to the distal needle tip as known or input to the system, allows the system to accurately determine the location and orientation of the entire length of the needle 100 relative to the sensor array 90. Optionally, the distance between the magnetic element 110 and the distal needle tip is known or input to the guide system 10. This then allows the guide system 10 to overlay an image of the needle 100 onto an image generated by the ultrasound beam 122 of the ultrasound probe 40. FIGS. 6A and 6B show an example of such overlay of the needle onto an ultrasound image. In particular, FIGS. 6A and 6B each show a screenshot 130 that may be represented, for example, on the display 30 (FIG. 2). In FIG. 6A, an ultrasound image 132 is shown, including a representation of the skin surface 120 and blood vessels 126. The ultrasound image 132 corresponds, for example, to an image acquired by the ultrasound beam 122 shown in FIGS. 5A and 5B.

[0058] Screenshot 130 further shows a virtual needle image 134 representing the position and orientation of needle 100 as determined by guide system 10 as described above. Because the system can determine the location and orientation of needle 100 relative to sensor array 90, the system can accurately determine the position and orientation of needle 100 relative to ultrasound image 132 and superimpose it thereon for representation on display 30 as needle image 134. Adjustment of the positioning of needle image 134 on ultrasound image 132 is performed by a suitable algorithm executed by processor 22 or other suitable component of guide system 10.

[0059] The magnetic sensor 92 is configured to continuously detect the magnetic field associated with the magnetic element 110 of the needle 100 during operation of the guide system 10. In some embodiments, rather than incorporating a magnetic element 110 with a magnetic field, the needle 100 itself may be magnetized to generate a magnetic field, thus requiring fewer components. Examples of magnetized needles, magnetization systems, and magnetizers are described in U.S. Patent Application Publication No. 2018 / 0310955, which is incorporated herein by reference in its entirety. The process of continuous detection by the sensor allows the guide system 10 to continuously update the position and orientation of the needle image 134 for representation on the display 30. Thus, the advancement or other movement of the needle 100 is represented in real time by the needle image 134 on the display 30. It should be noted that the guide system 10 can continuously update both the ultrasound image 132 and the needle image 134 on the display 30 as the movement of the ultrasound probe 40 and the needle 100 occurs during the placement procedure or other operation.

[0060] FIG. 6A further illustrates that in one embodiment, the guide system 10 may render an illumination path 136 based on the current position and orientation of the needle 100, as represented by the needle image 134. The illumination path 136 assists the clinician in determining whether the current orientation of the needle 100, as represented by the needle image 134 on the display 30, will reach a desired internal body target, such as the blood vessel 126 shown here. Again, when the orientation and / or position of the needle image 134 changes, the illumination path 136 is correspondingly modified by the guide system 10. A target 138 indicating the point where the illumination path 136 intersects with the plane of the ultrasound image 132 may also be rendered by the guide system 10 on the display 30. As shown in FIG. 6A, in this example, the target 138 is located within the blood vessel 126 depicted in the ultrasound image 132. It should be noted that the position of the target 138 on the display 30 may also be modified when the needle 100 and / or the ultrasound image 132 are adjusted. Screenshot 130 also includes a probability region 139, shown here as a box, which indicates the range of any possible errors in the system due to the length of the needle, the stiffness and flexibility of the needle, the field strength of the magnetic element, the field strength of the magnetic needle, magnetic interference, possible misalignments between the magnetic axis of the magnetic element and the longitudinal axis of the needle, the orientation of the sensor array relative to the ultrasound imaging plane, etc.

[0061] FIG. 6B illustrates that in one embodiment, the screenshot 130 may be configured to be oriented such that the ultrasound image 132 and the needle image 134 are displayed in a three-dimensional view. This allows the angle and orientation of the needle 100 as represented by the needle image 134 to be ascertained and compared to the intended target imaged by the ultrasound image 132. It should be noted that the screenshot 130 is merely an example of a possible representation generated by the guide system 10 for display. Indeed, other visual representations may be used. It should be further noted that the particular area of ​​the body being imaged is merely an example. The system may be used to ultrasound image a variety of body parts and should not be limited to those explicitly depicted in the accompanying drawings. Furthermore, the system as shown and described herein may be included as a component of a larger system or configured as a stand-alone device, if desired. It is also recognized that in addition to the visual information provided on the display 30, audio information, such as beeps, tones, and the like, may also be used by the guide system 10 to assist the clinician during positioning and insertion of the needle into the patient's body.

[0062] In one embodiment, the length of the needle (or other aspect of the medical component) may be determined by a measurement of a characteristic of the magnetic element 110 or needle of the probe / system, such as the field strength. For example, in one embodiment, the magnetic element 110 or magnetized needle of the needle 100 may be positioned at a predetermined distance from or at a predetermined location relative to the ultrasound probe 40. With the magnetic element 110 or needle so positioned, the sensor array of the ultrasound probe 40 may detect and measure the field strength of the associated magnetic element 110. The system may compare the measured field strength to a stored list of possible field strengths corresponding to different known lengths of the needle. The system may compare the two strengths to determine the length of the needle. Then, needle location and subsequent needle insertion may proceed as described herein. In another embodiment, instead of holding the magnetic element 110 stationary at a predetermined location, the magnetic element 110 or magnetic needle can be moved around the ultrasonic probe 40 such that multiple field strengths are measured by the ultrasonic probe 40. Aspects that can be modified to provide different field strengths for a set of magnetic elements include the size, shape, and composition of the magnetic elements.

[0063] Further details regarding the use of the guide system 10 in guiding a needle or other medical instrument in association with ultrasound imaging of a targeted internal body portion ("target") of a patient, according to one embodiment, are now provided. With the needle 100 and its magnetic elements positioned a suitable distance (e.g., 2 feet or more) from the ultrasound probe 40 including the sensor array 90, the probe is used to ultrasound image the target within the patient's body that the needle is intended to intersect upon percutaneous insertion, for representation on the display 30 of the guide system 10. Calibration of the guide system 10 may then be initiated, in which an algorithm is executed by the processor 22 of the console 20 to determine a baseline of any ambient magnetic fields in the vicinity of where the procedure will be performed. As described below, the guide system 10 may generate status indicators by various feedback systems to inform the clinician that a calibration needs to be performed and / or that a calibration is currently in progress. The guide system 10 may also be informed of the overall length of the needle 100 and / or the position of the magnetic element relative to the distal needle tip, such as by user input, automatic detection, or other suitable methods, as described above.

[0064] The needle 100 may then be brought within range of the magnetic sensors 92 of the sensor array 90 of the ultrasound probe 40. Each of the magnetic sensors 92 detects the magnetic field strength associated with the magnetic element 110 or needle of the needle 100, and the data is transferred to the processor 22. In one embodiment, such data may be stored in memory until needed by the processor. Once the magnetic sensors 92 detect the magnetic field, a suitable algorithm is executed by the processor 22 to calculate the magnetic field strength of the magnetic needle or magnetic element 110 of the needle 100 at a predicted point in space relative to the probe. The processor 22 then compares the actual magnetic field strength data detected by the magnetic sensor 92 to the calculated field strength value. Note that this process is further described in the U.S. patents identified above. This process may be performed iteratively until the calculated value for the predicted point matches the measured data. When this match occurs, the magnetic element 110 has been located and positioned in three-dimensional space. Using the magnetic field strength data as detected by the magnetic sensor 92, the pitch and yaw (i.e., orientation) of the magnetic element 110 may also be determined. Used in conjunction with the known length of the needle 100 and the position of the needle's distal tip relative to the magnetic elements, the needle's position and orientation may be accurately represented by the guide system 10 and represented on the display 30 as a virtual model, i.e., needle image 134. It should be noted that the predicted and actual detected values ​​must match within a predetermined tolerance or confidence level in one embodiment in order for the guide system 10 to be able to represent the needle.

[0065] The rendering of needle image 134 of needle 100 as described above is performed in this embodiment by overlaying the needle image on ultrasound image 132 on display 30 (FIGS. 6A, 6B). Suitable algorithms of guide system 10 as executed by processor 22 or other suitable components further determine illumination path 136, target 138, and prospective region 139 (FIGS. 6A, 6B) for rendering on display 30 over ultrasound image 132 of the target. The prediction, detection, comparison, and rendering processes described above are performed iteratively to continuously track the movement of needle 100 in real time.

[0066] A clinician may wish to improve ultrasound imaging by positioning the probe within the appropriate calibration region by adjusting or fine-tuning the placement of the needle and / or probe during a procedure. In many embodiments, the guide system 10 may provide sensory feedback to the clinician to facilitate better placement within the calibration region, thereby resulting in a more efficient procedure by reducing the risk of improper movement or the time required to complete. The guide system 10 may facilitate this by providing the clinician with status indicators based on measurements or other data received during the procedure. Such status indicators may inform the clinician, for example, that the needle 100 and / or the ultrasound probe 40 needs to be calibrated, that the ultrasound probe 40 needs to be moved a certain amount about its axis to remain in the calibration zone, or if there is a communication failure within the guide system 10. In general, communicating these status indicators to the clinician during a procedure may require the clinician to interrupt focus on a given task to seek out the current status within another location of the guide system 10. For example, a clinician concentrating on directing the ultrasound probe 40 along the patient's skin surface 120 may require the clinician's visual attention during the process, which may be diverted by needing to look at the display 30 to see the current status. Conversely, a clinician looking at the ultrasound area of ​​the display 30 during a procedure may need to be distracted by looking elsewhere on the screen or at the positioning of the ultrasound probe 40 to determine the current status of the system.

[0067] It is therefore desirable to provide sensory feedback so that the clinician can receive feedback without substantially changing the focus or area of ​​focus of the clinician. Thus, by providing a status indicator, for example, on the ultrasound probe 40, on the display 30, or via a wearable device or other sound, the clinician can remain focused on a particular task without having to look elsewhere.

[0068] 7A and 7B, one embodiment for providing sensory feedback during the guiding process is described. An ultrasound probe 40 is shown with two indicator lights located on the top of the probe, specifically a left status light 140 and a right status light 142. The probes shown in FIGS. 7A-7D are shown in their top views, which are generally oriented upward and within the clinician's field of view during the guiding process. The left status light 140 and the right status light 142 are located on opposite sides of the probe, and between them is a communication cord entry 144 that provides an opening through which a communication cord can enter the ultrasound probe 40.

[0069] In one embodiment, the left and right status indicator lights 140, 142 may be configured to change from an "off" state (see FIG. 7A) to an "on" state (see FIG. 7B), optionally in one or more sequential patterns. Additionally, the left and right status indicator lights 140, 142 may include multiple light emitting diodes (LEDs) within each status indicator light to provide a variety of colors depending on the type of LED selected. In some embodiments, the LEDs may be multiple colors and programmably change color instead of multiple single color LEDs. In general, the LEDs may be located within the housing of the ultrasound probe 40 under a transparent or translucent window within a cutout in the probe housing. In the embodiment shown in FIGS. 7A-7C, the cutout in the probe housing and the window located therein include a shape that can convey directional information, such as a two-way arrow.

[0070] The LEDs of the ultrasound probe 40 can be independently operated with respect to state (i.e., off and on) as well as intensity and color. FIG. 7A shows the left and right status indicator lights 140, 142 in an "off" state, while FIG. 7B shows the left and right status indicator lights 140, 142 in an "on" state. Those skilled in the art will appreciate that a wide variety of information can be indicated by possible combinations of the controllable characteristics of the LEDs. For example, one or more series of light patterns can convey information such as a status associated with the calibration of a component of the guide system, a suggested direction for moving the probe to improve tracking accuracy, and the like. Indeed, one or more series of light patterns can include multiple colors to indicate a suggested direction for moving the probe to improve tracking accuracy, and a change between at least two of the multiple colors is associated with the suggested direction.

[0071] The LEDs may indicate to the clinician when the ultrasound probe 40 or needle 100 needs calibration, for example, by emitting a pair of solid yellow lights on the left and right status lights 140, 142. Similarly, a flashing yellow light may be programmed to tell the clinician that a calibration is currently in progress. Other color and intensity combinations may communicate that the ultrasound probe 40 or other components are not properly connected or in proper communication within the guidance system 10 (for example, by showing a solid red light on both the left and right status lights 140, 142). The presence of a solid green light of another color may tell the clinician that tracking is now ready and can begin.

[0072] By locating the LED within the shape of the cutout, e.g., a bidirectional arrow, the state, color, and intensity of the LED can communicate to the clinician how to adjust the pitch or other orientation of the needle 100 and / or ultrasound probe 40 during guiding. This can help, for example, to keep the ultrasound probe 40 and / or needle 100 within a calibration zone and can reduce the effort required by the clinician to obtain status updates since the clinician's eyes can be focused on the ultrasound probe 40 rather than the display 30 if desired.

[0073] Additionally, LEDs may be placed in different locations under the cutout of the probe housing. In this manner, increased directional information may be conveyed to the clinician. FIG. 7C illustrates an ultrasound probe 40 with the LEDs centrally located in the left and right status lights 140, 142 illuminated. In one embodiment, the LEDs are located within or below the window of the left status light 140 at the center of the window, the forward facing portion 146, and the rearward facing portion 147. A similar arrangement may be found for the right status light 142, including the forward and rearward facing portions 145, 149 of the window, in addition to an LED in the center of the two-way arrow cutout below the window.

[0074] By locating LEDs at different points on the bidirectional arrow cutouts on the left and right status lights 140, 142, the amount of status information can be conveyed by changing the state, color, and intensity of the lights. For example, by illuminating either end of the bidirectional arrow, the clinician may be informed that the pitch of the ultrasound probe 40 needs to be changed by moving the probe pitch toward the direction indicated by the LED. In other embodiments, by illuminating LEDs at opposite ends of the bidirectional arrows on the left and right status lights 140, 142, the guidance system 10 may indicate that the yaw of the ultrasound probe 40 needs to be adjusted in the indicated direction.

[0075] The magnitude of the adjustment required may also be conveyed by a change in color and / or light intensity. For example, a green LED illuminated in the forward facing portion 146 of the window of the left status light 140, in conjunction with a green LED illuminated in the rearward facing portion 149 of the right status light 142, may convey a status that the probe yaw needs to be adjusted in a clockwise direction. In one embodiment, the LED may change color from green to yellow to red to indicate increasingly stronger indications to change the probe yaw in the indicated direction. Similarly, the LED may provide increasingly stronger illumination in association with suggested changes in the movement of the ultrasound probe 40.

[0076] As shown in FIG. 7D, the left and right status lights 140, 142 may include three-way cutouts in the ultrasound probe 40. The left status light 140 is comprised of a forward-facing portion 146 (e.g., an arrow), a rearward-facing portion 147 (e.g., an arrow), and a sideways-facing portion 148 (e.g., an arrow) of a window with LEDs below it. Similarly, the right status light 142 includes a forward-facing portion 145 (e.g., an arrow), a rearward-facing portion 149 (e.g., an arrow), and a sideways-facing portion 141 (e.g., an arrow) of a window with LEDs below it. In some embodiments, the addition of the sideways portions 141, 148 may communicate to the clinician a suggested adjustment, such as moving the ultrasound probe 40 to either side. In one embodiment, the sideways portions 141, 148 include separate LEDs that may be illuminated separately from the other LEDs of the left and right status lights 140, 142. This allows for another degree of communication between the guidance system and the clinician by varying the state, color, and / or intensity of the lights on either the lateral portion 141 or the lateral portion 148. In this manner, the three-way left and right status indicator lights 140, 142 can inform the clinician how to orient the ultrasound probe 40 along three separate axes without having to look at the display 30.

[0077] 8A and 8B, these figures show another embodiment of an ultrasound probe 840 in which a bi-directional status indicator light 150 is located on the front side of the ultrasound probe 840. The bi-directional indicator light 150 includes a left-facing portion 152 (e.g., an arrow) and a right-facing portion 154 (e.g., an arrow). The embodiment shown in FIG. 8B has a bi-directional indicator light 150 that is turned "on" to provide a continuous light. As mentioned above, this type of status indicator can be used to inform the clinician of, for example, a calibration status (yellow), an error condition (red), or a ready state (green). Similarly, as shown in FIG. 8B, the bi-directional status indicator light 150 can be illuminated in a particular area to increase the amount of detail and information that can be conveyed to the clinician. Methods and means of using different regions of a multi-region status indicator light are described above in FIG. 7C and 7D and can be used in the ultrasound probe 840 shown in FIG. 8B, as well as any other similar embodiments.

[0078] 9A-9D, these figures show screenshots 930 of status display boxes 162 (e.g., colored boxes) on the display 30 during operation of the guide system 10. As mentioned above, the display 30 of the guide system 10 may show images generated by the ultrasound beam 122 with an image of the needle 100 superimposed as the needle location is tracked and determined. While the clinician is viewing the images presented on the display 30, it may be beneficial to communicate issues with calibration, readiness, and / or failures of the guide system 10.

[0079] As shown in FIG. 9A, the screenshot 930 of the display 30 includes a status display box 162 surrounding an ultrasound image area. In one embodiment, the status display box 162 is a static (e.g., non-blinking) colored (e.g., yellow or a similar high contrast color) display box to inform the clinician that the guide system 10 is requesting calibration. The status display box is configured to allow the clinician to easily notice and see the status display box 162, along with the associated status display text 164 and / or status display icon 166. The status display box 162, along with the associated status display text 164 and status display icon 166, may be designed to be easily sensed by the clinician even when the clinician is concentrating on the ultrasound area during a procedure. For example, the status display box 162 may be a high contrast color that is easily perceived and recognized by the clinician through the clinician's peripheral cognitive abilities without having to change focus from the ultrasound or other image on the display 30.

[0080] Similarly, screenshot 930 of Figure 9B corresponds to a calibration in progress, for example, after a clinician has perceived one or more of status indicators 162, 164, 166 of Figure 9A and initiated the calibration process. As with status indicator box 162 of Figure 9A, status indicator box 162 of Figure 9B may be colored in a suitable color (e.g., yellow or another high contrast color) for perception by the clinician. In one embodiment, a status indication method for system 10 performing a calibration is to display status indicator box 162 with accompanying status indicator text 164 in a flashing yellow color.

[0081] 9C and 9D, these figures further show a screenshot 930 of the display 30 including a status indicator box 162. When the guide system 10 is in a ready state for use, the status box indicator 162 may be displayed in a lower contrast along with the accompanying status indicator text 164. In one embodiment, the guide system 10 displays the status indicator box 162 continuously in green when the ready state is reached and the clinician can begin or continue the procedure. In other embodiments, the guide system 10 may remove the status indicator box 162 while in the ready state and generate more contrast when a change in status triggers the display of another status indicator box 162 and the accompanying status indicator text 164. The ultrasound probe 40 or some other component may, for example, lose communication and report some kind of error or failure within the guide system 10. This may trigger the display of the status indicator box 162 along with the accompanying status indicator icon 166 in a high contrast color as shown in FIG. 9D. In one embodiment, detection of the presence of a fault or certain errors in the guide system 10 prompts a status indicator box 162 around the ultrasound image to be continuously displayed in red, optionally along with a status indicator icon 166 as an error icon. Once the fault or error is corrected, the display 30 may remove or otherwise modify the status indicator box 162 and the associated status indicator icon 166. In this manner, the guide system 10 is configured to prompt reaction and correction by the clinician, which may increase the overall efficiency of the procedure being performed.

[0082] With the above in mind, status display box 162 provides a pattern (e.g., a color pattern) useful for indicating a status (e.g., calibration, error, ready, etc.) associated with guide system 10 or its components, such as by its color (e.g., green, yellow, red, etc.), animation (e.g., flashing, flickering, etc.), or lack thereof.

[0083] It may be appreciated that other forms of sensory-based feedback may be achieved to reduce clinician distraction and increase focus while performing a procedure. In some embodiments, the ultrasound probe 40 or the guidance system display 30 may provide audible cues corresponding to various statuses of the guidance system 10. The level, pitch, and tone may be altered based on the different statuses available. These audible status indication sounds may be preprogrammed or adjusted by the clinician based on preferences.

[0084] In one embodiment, the ultrasonic probe 40 may include at least one vibration generating component to provide a noticeable level of tactile feedback. As with other status indicators, the vibration generated by the ultrasonic probe 40 may vary depending on the status being indicated. The ultrasonic probe 40 may, for example, produce a low level of vibration when the probe is being moved outside of a calibration zone, with the strength of the vibration level increasing as the probe is moved further outside of its calibration zone. Similarly, short burst vibrations may be used in succession to indicate that calibration may be required and / or that calibration is being performed. It will be appreciated that low levels of vibration are generally used to avoid vibrations interfering with the use of the ultrasonic probe 40 and needle 100.

[0085] Sensory feedback may be generated by a wearable device linked to the clinician and communicated to the clinician. In one embodiment, the user may have smart glasses that may generate images related to status alerts that are visible within the clinician's field of view, so that the clinician is aware of the guidance system status no matter what he or she is looking at. Similarly, a smartwatch may be wirelessly connected to the guidance system 10, thereby providing status indications by vibration alerts or triggered audible and / or visual cues on the smartwatch. For example, the smartwatch may be configured to provide tactile feedback to the clinician, similar to the vibration components present in the ultrasound probe 40, as described above. In other embodiments, the smartwatch may be configured to deliver audible tones, similar to the audible status notification tones, as also described above.

[0086] While particular combinations of color, orientation, direction, and feedback strength have been described in the figures above, it will be appreciated that other combinations may be used based on the desired application. Similarly, while many of the embodiments described above include LEDs, other light emitting elements may be used to generate similar status indications. Finally, while the status indicator boxes 162, associated status indicator text 164, and status indicator icons 166 in Figures 9A-9D are shown surrounding an ultrasound image, it will be appreciated that other embodiments providing alternative arrangements and combinations of images of similar contrast on the display 30 may be used depending on the desired application.

[0087] The embodiments of the present invention may be provided in other specific forms without departing from the spirit of the disclosure. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the embodiments is therefore indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. 1. A guide system for guiding insertion of a needle into a patient's body, comprising: an ultrasound imaging device including a probe for ultrasonically imaging a target within an internal body portion; at least one sensor included in the probe that senses a magnetic field associated with the needle; a processor that receives magnetic field data sensed by the at least one sensor to determine a position of the needle in three-dimensional space; a display representing the determined position of the needle together with an image of a target within the body portion; the ultrasound imaging device is configured to provide at least one indication of a status by sensory feedback based on the determined position; the sensory feedback is delivered by visible light generated by a plurality of light emitting diodes located on the probe, the plurality of light emitting diodes being configured to emit a first series of light patterns to indicate a proposed direction for moving the probe to enhance tracking accuracy; The plurality of light emitting diodes are Illuminating a first directional indicator disposed on a first side of the probe, the first directional indicator including a first arrow pointing in a first direction and a second arrow pointing in a second direction opposite the first direction; and illumination of a second directional indicator disposed on a second side of the probe opposite the first side, the second directional indicator including a third arrow pointing in the first direction and a fourth arrow pointing in the second direction; configured to provide a first subset of the plurality of light emitting diodes configured to illuminate the first arrow and the third arrow to suggest movement of the probe according to a first axis; a second subset of the plurality of light emitting diodes configured to illuminate the first arrow and the fourth arrow to suggest movement of the probe about a second axis perpendicular to the first axis.

2. The guidance system of claim 1 , wherein the plurality of light emitting diodes are configured to emit a second series of light patterns to indicate at least one status associated with calibration of a component of the guidance system.

3. The guidance system of claim 2 , wherein the second series of light patterns includes using multiple colors to indicate the proposed direction.

4. The guidance system of claim 3 , wherein a change between at least two of the plurality of colors is associated with the proposed direction.

5. 4. The guidance system of claim 3, wherein at least two of the plurality of light emitting diodes are positioned on opposite sides of the probe, and a change between at least two of the plurality of colors in the second series of light patterns is associated with the proposed direction.

6. The guidance system of any one of claims 1 to 5, wherein the sensory feedback is delivered by means of a visual indicator on the display.

7. The guidance system of claim 6 , wherein the display is configured to emit a first color pattern to indicate at least one status associated with calibration of a component of the guidance system.

8. The guidance system of claim 6 , wherein the display is configured to emit a second color pattern to indicate at least one error in the guidance system.

9. The guidance system of claim 6 , wherein the display is configured to emit a third color pattern to indicate a ready state within the guidance system.

10. The guidance system of claim 1 , wherein the sensory feedback is delivered by visual images generated by a wearable device connected to the guidance system.

11. The guide system of any preceding claim, wherein the sensory feedback is delivered by tactile feedback generated within the probe.

12. The guidance system of any one of claims 1 to 11, wherein the sensory feedback is delivered by an audible signal delivered by a speaker within the guidance system.

13. 1. A method of operating a guide system for guiding a needle for insertion into a patient's body using imaging techniques, comprising: The guide system includes an imaging device including a probe, a processor, and a display; (a) imaging a target within the body with the imaging device including the probe; (b) the processor sensing, by the probe, a detectable characteristic related to the needle; (c) the processor determining a determined location of the needle in at least two dimensional space according to data related to the detectable characteristics and the sensed degree of bending; (d) the display displays the determined position of the needle relative to the target together with an image of the target; and (e) the processor providing at least one indication of a status by sensory feedback based on the determined position of the needle; the sensory feedback is delivered by visible light generated by a plurality of light emitting diodes located on the probe, the plurality of light emitting diodes being configured to emit a first series of light patterns to indicate a proposed direction for moving the probe to enhance tracking accuracy; The plurality of light emitting diodes are Illuminating a first directional indicator disposed on a first side of the probe, the first directional indicator including a first arrow pointing in a first direction and a second arrow pointing in a second direction opposite the first direction; and illumination of a second directional indicator disposed on a second side of the probe opposite the first side, the second directional indicator including a third arrow pointing in the first direction and a fourth arrow pointing in the second direction; configured to provide The method of operating the guide system further comprises: (f) the processor actuating a first subset of the plurality of light emitting diodes to illuminate the first arrow and the third arrow to suggest movement of the probe along a first axis; (g) the processor operating a second subset of the plurality of light emitting diodes to illuminate the first arrow and the fourth arrow to suggest movement of the probe about a second axis perpendicular to the first axis; A method of operating a guide system comprising:

14. 14. The method of claim 13, wherein the plurality of light emitting diodes are configured to emit a second series of light patterns to indicate at least one status associated with calibration of a component of the guide system.

15. 15. The method of claim 14, wherein the second series of light patterns includes using multiple colors to indicate the proposed direction.

16. The method of claim 15 , wherein a change between at least two of the plurality of colors is associated with the proposed direction.

17. 16. The method of claim 15, wherein at least two of the plurality of light emitting diodes are positioned on opposite sides of the probe, and a change between at least two of the plurality of colors of the second series of light patterns is associated with the proposed direction.

18. A method according to any one of claims 13 to 17, wherein the sensory feedback is delivered by means of a visual indicator on a display.

19. 20. The method of claim 18, wherein displaying further comprises illuminating a first color pattern to indicate at least one status associated with calibration of the at least one component.

20. 20. The method of claim 18, wherein the indicating further comprises illuminating a second color pattern to indicate the at least one error.

21. 20. The method of claim 18, wherein indicating further comprises illuminating a third color pattern to indicate a ready state.

22. A method for operating a guide system according to any one of claims 13 to 21, wherein the sensory feedback is delivered by visual images generated by a wearable device.

23. A method according to any one of claims 13 to 22, wherein the sensory feedback is delivered by tactile feedback generated within the probe.

24. The method of any one of claims 13 to 23, wherein providing the sensory feedback further comprises delivering an audible signal by a speaker.

25. the first direction indicator further includes a fifth arrow pointing in a third direction perpendicular to the first direction; the second direction indicator further includes a sixth arrow pointing in a fourth direction opposite the third direction; The method of operating the guide system further comprises: (h) the processor actuating a third subset of the plurality of light emitting diodes to illuminate the fifth arrow or the sixth arrow to suggest movement of the probe along a third axis perpendicular to the first axis and the second axis. The method of claim 13 , comprising:

26. 1. A guide system for guiding insertion of a needle into a patient's body, comprising: an ultrasound imaging device including a probe for ultrasonically imaging a target within the body portion within a calibration zone determined by a calibration process; at least one sensor included in the probe that senses a magnetic field associated with the needle; a processor that receives magnetic field data sensed by the at least one sensor to determine a position of the needle in three-dimensional space within the calibration zone; a display representing the determined position of the needle together with an image of a target within the body portion; the ultrasound imaging device is configured to provide at least one indication of a status by sensory feedback from a plurality of light emitting diodes disposed on the probe; The sensory feedback includes: generating a visual indication that the probe is being moved near a boundary of the calibration zone; and generating a low level of vibration in the probe when the probe is moved outside the calibration zone; The plurality of light emitting diodes are Illuminating a first directional indicator disposed on a first side of the probe, the first directional indicator including a first arrow pointing in a first direction and a second arrow pointing in a second direction opposite the first direction; and illumination of a second directional indicator disposed on a second side of the probe opposite the first side, the second directional indicator including a third arrow pointing in the first direction and a fourth arrow pointing in the second direction; configured to provide the first direction indicator further includes a fifth arrow pointing in a third direction perpendicular to the first direction; The second direction indicator further includes a sixth arrow pointing in a fourth direction opposite the third direction.

27. a first subset of the plurality of light emitting diodes configured to illuminate the first arrow and the third arrow to suggest movement of the probe according to a first axis; 27. The guide system of claim 26, wherein a second subset of the plurality of light emitting diodes is configured to illuminate the first arrow and the fourth arrow to suggest movement of the probe about a second axis perpendicular to the first axis.

Images