CATHETER TRACKING AND PLACEMENT SYSTEM INCLUDES LIGHT EMITTING DIODE ARRAY - Patent application

Abstract

A tracking system configured to track the movement of a medical device. The medical device may include a proximal portion having a magnetic element attached thereto. The system may include a console with a display and a TLS sensor. The TLS sensor may be disposed on a patient and may include an LED array. The LED array may indicate the proximity of the medical device to the TLS sensor. The LED array may provide different colors and / or project images to display information regarding the location, orientation, distance, or depth of the medical device. The display may be disposed on a surface above the TLS sensor and configured to display an image of the medical device disposed below it, along with additional information and the collective image, thereby providing a standalone unit.

Description

[Technical field]

[0001] The present invention relates to a catheter tracking and placement system that includes a light emitting diode array. [Background technology]

[0002] Most catheter placement devices require various medical devices to be coupled with a separate stand-alone display that displays medical device location information or overlaid imaging images. The display is necessarily located away from the medical device location and the patient, requiring the user to split time between the medical device insertion location and the display. This is particularly relevant for medical device tracking systems that require the user to both operate one or more medical devices at the patient's insertion site and consistently pay attention to a display positioned elsewhere. Therefore, there is a need for a tip locating device system and method that is placed on or near the patient and shows the user the location of the medical device within the patient's body. Summary of the Invention [Means for solving the problem]

[0003] Briefly summarized, embodiments disclosed herein relate to a tracking system configured to track the movement of a medical device. The system includes a tip location system ("TLS") sensor including an LED array. The LED array may indicate a degree of proximity of the medical device to the TLS sensor. The LED array may provide different colors or project images to display information regarding the location, orientation, distance, or depth of the medical device. In embodiments, a display is disposed on a surface above the TLS sensor and configured to display an image of the medical device disposed thereunder, along with additional information and collective imagery.

[0004] In an aspect of the present invention, a medical device tracking system is disclosed that includes a tracking circuit designed to track movement of a medical device within the body, the tracking circuit including a receiving component designed to detect a magnetic field associated with the medical device and generate magnetic field strength data, and a processor designed to iteratively calculate position data of the medical device according to the magnetic field strength data; and a sensor disposed on a patient's skin surface, the sensor including a light emitting diode (LED) array, the LED array including one or more LED lights, the LED array indicating a degree of proximity of the medical device to the sensor.

[0005] In some embodiments, the LED array includes a first LED light disposed proximate a first side of the sensor, a second LED light disposed proximate a second side of the sensor, and a third LED light disposed proximate a central portion of the sensor, and one of the first, second, and third LED lights is illuminated when the medical device is in its vicinity. One or more of the LED lights of the LED array display two or more colors. The two or more colors indicate one of a distance or a depth of the medical device relative to the sensor. The LED array includes a row and column arrangement of LED lights disposed on a surface above the sensor.

[0006] A tracking system for tracking a medical device is also disclosed, the medical device including a magnetic element attached to a distal portion thereof, the system including a sensor configured to track the movement of the medical device. The sensor includes a receiving component configured to detect a magnetic field associated with the magnetic element and generate magnetic field strength data, and a processor designed to iteratively calculate position data of the distal portion of the medical device according to the magnetic field strength data and simulate the insertion of the distal portion of the medical device within the patient's body. The system includes a display disposed on a surface above the sensor. The display is configured to display an image from the calculated position data of the distal portion of the medical device.

[0007] In some embodiments, the display displays a symbol indicating one of a location, orientation, distance, or depth of the medical device when the medical device is in close proximity to the sensor. The display displays an image of the medical device when the medical device is positioned under the sensor. The symbol includes one of an alphanumeric symbol, an image, or an icon. The display further displays one of additional information or an imaged image of the patient to provide an expanded view of the medical device within the patient and positioned under the sensor. The imaged image of the patient includes one of an x-ray, ultrasound, PET, CT, or MRI image of the patient. The imaged image of the patient is modified according to the position of the sensor on the patient to correspond to an imaged image of a portion of the patient positioned under the sensor.

[0008] Also disclosed is a method for tracking a medical device that includes positioning a sensor at a target site on a patient, the sensor including an LED array of one or more LED lights, inserting the medical device into the patient's vasculature, and indicating a degree of proximity of the medical device to the sensor by illuminating one or more LED lights of the LED array.

[0009] In some embodiments, the degree of proximity of the medical device to the sensor includes one of a distance or depth of the medical device in three-dimensional space. One or more LED lights of the LED array display two or more colors, the two or more colors indicating the degree of proximity of the medical device to the sensor. One or more LED lights of the LED array are illuminated when the medical device is positioned directly underneath. One or more LED lights of the LED array project a symbol on the surface of the patient to indicate one of a location, a direction, a distance, or a depth of the medical device relative to the sensor. The symbol includes one of an alphanumeric symbol, a picture, or an icon. The LED array is a display configured to provide an image of the medical device when the medical device is positioned underneath the sensor.

[0010] A more detailed description of the present disclosure will now be given with reference to certain embodiments illustrated in the accompanying drawings. It will be understood that these drawings represent only typical embodiments of the present invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the present invention will be described and explained with additional features and details using the following accompanying drawings. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a block diagram illustrating various elements of an integrated system for intravascular placement of a catheter, according to one exemplary embodiment. [Diagram 2] 2 is a schematic diagram of a patient and a catheter inserted therein with the aid of the integrated system of FIG. 1; [Diagram 3] 2 is an exemplary console and display of the integrated system of FIG. 1. [Figure 4] FIG. 1 is a perspective view of a sensor according to an embodiment. [Diagram 5] FIG. 2 is a first plan view of a sensor according to an embodiment. [Figure 6] FIG. 6 is a second plan view of the sensor according to the embodiment of FIG. 5. [Figure 7] FIG. 6 is a third plan view of the sensor according to the embodiment of FIG. 5. [Figure 8] FIG. 6 is a fourth plan view of the sensor according to the embodiment of FIG. 5. [Figure 9] FIG. 2 is a first side view of a sensor according to an embodiment. [Figure 10] FIG. 10 is a second side view of the sensor according to the embodiment of FIG. 9. [Figure 11] FIG. 2 is a plan view of a sensor according to an embodiment. [Figure 12] FIG. 2 is a plan view of a sensor according to an embodiment. [Figure 13] FIG. 2 is a first plan view of a sensor according to an embodiment. [Figure 14] FIG. 14 is a second plan view of the sensor according to the embodiment of FIG. 13. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Reference is now made to the drawings, in which like structures are numbered likewise, and it is understood that the drawings are illustrative and schematic representations of exemplary embodiments of the concepts disclosed herein, and are not intended to be limiting and are not necessarily drawn to scale.

[0013] For clarity, the term "proximal" refers to a direction relatively closer to a clinician using the devices described herein, and the term "distal" refers to a direction relatively farther from the clinician. For example, the end of a catheter that is located inside a patient's body is considered to be the distal end of the catheter, and the end of the catheter that remains outside the body is the proximal end of the catheter. Additionally, the terms "including," "having," and "having" have the same meaning as the term "comprising" when used herein, including the claims.

[0014] Similarly, the terms "upper", "lower", "top", "bottom", "lower", "upper" etc. used to describe the system are used with reference to the orientation described in the embodiments. The terms "left" and "right" are used consistently throughout this disclosure and are used to describe structures from the perspective of a user or clinician using the equipment.

[0015] Assisted Catheter Placement The embodiments generally relate to a catheter placement system configured to accurately place a catheter in a patient's vasculature. In one embodiment, the catheter placement system uses at least two modalities to improve the accuracy of catheter placement: 1) ultrasound-assisted guidance to introduce the catheter into the patient's vasculature; and 2) a tip location / navigation system ("TLS"), or magnetic-based tracking of the catheter tip while navigating through tortuous vasculature paths, to detect and facilitate correction of any tip malposition during such navigation. The ultrasound guidance and tip location features of the system according to one embodiment are integrated into a single device for use by the clinician placing the catheter. By incorporating these two modalities into a single device, the catheter placement process is simplified and catheter placement is relatively quick. For example, the integrated catheter placement system allows ultrasound and TLS activity to be viewed on a single display of the integrated system. Additionally, controls on the ultrasound probe or TLS sensor of the integrated device, which are maintained within the patient's sterile field during catheter placement, can be used to control the functions of the system, eliminating the need for the clinician to reach into the sterile field to control the system.

[0016] In another embodiment, a third modality, ECG signal-based catheter tip guidance, is included in the integrated system to enable guiding of the catheter tip to a desired location relative to the patient's cardiac nodes from which the ECG signal originates. Such ECG-based positioning assistance is also referred to herein as "tip confirmation."

[0017] The combination of the above three modalities according to one embodiment allows the catheter placement system to facilitate relatively high accuracy of catheter placement within the patient's vasculature, i.e., placement of the distal tip of the catheter at a predetermined desired location. Furthermore, because of the ECG-based guidance of the catheter tip, correct placement of the tip may be confirmed without the need for confirmatory x-rays. This, in turn, may reduce patient exposure to potentially harmful x-rays, the costs and time associated with transporting the patient to an x-ray suite, costly and inconvenient catheter repositioning procedures, etc.

[0018] Reference is initially made to Figures 1 and 2, which illustrate various components of a catheter placement system ("system"), generally designated 10, constructed in accordance with one exemplary embodiment. As shown, system 10 generally includes a console 20, a display 30, a probe 40, and a sensor 50, each of which is described in further detail below.

[0019] FIG. 2 illustrates the overall relationship of these components to a patient 70 during a procedure in which a catheter 72 is placed through a skin insertion site 73 and into the patient's vasculature. 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 system 10 is ultimately used to position the distal tip 76A of the catheter 72 at a desired location within the patient's vasculature. In one embodiment, the desired location of the catheter distal tip 76A is in the lower third of the superior vena cava ("SVC"), for example, very close to the patient's heart. Of course, the system 10 may be used to place the catheter distal tip in other locations. The catheter proximal portion 74 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 that extend proximally from the hub.

[0020] An exemplary implementation of the console 20 is shown in Figure 3, although it is recognized that the console may take a variety of forms. A processor 22, including non-volatile memory, such as EEPROM, is included in the console 20 to control the system functions during operation of the system 10, and thus functions as a control processor. A digital controller / analog interface 24 is also included with the console 20 and communicates with the processor 22 and other system components to govern the interfaces between the probes 40, sensors 50, and other system components.

[0021] The system 10 further includes ports 52 for connecting with sensors 50 and 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. A power connection 56 is included with the console 20 to allow for operative connection with an external power source 58. An internal battery 60 may also be used, with or without an external power source. A power management circuit 59 is included with the console's digital controller / analog interface 24 to regulate power utilization and distribution.

[0022] The display 30 in this embodiment is integrated into the console 20 and is used to display information to the clinician during the catheter placement procedure. In another embodiment, the display may be separate from the console. It will be seen that the content displayed by the display 30 changes according to which mode the catheter placement system is in: US, TLS, or in other embodiments, ECG tip confirmation. In one embodiment, the console button interface 32 (see FIG. 1, FIG. 3), and buttons included on the probe 40, TLS sensor 50, or a combination thereof, may be used for the clinician to quickly invoke a desired mode on the display 30 to assist in the placement procedure, further details of which are disclosed herein. In one embodiment, information from multiple modes, such as TLS and ECG, may be displayed simultaneously. Thus, a single display 30 of the system 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 distal tip placement against the patient's cardiac nodes (as in the embodiment described below). In one embodiment, the display 30 is an LCD device. In one embodiment, the display 30 is a touch screen device.

[0023] 1 shows that the probe 40 includes a button and memory controller 42 for managing the operation of the buttons and the probe, which in one embodiment may include non-volatile memory such as an EEPROM. The button and memory controller 42 is in operative communication with a probe interface 44 of the console 20, which 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.

[0024] Further details of the catheter placement system 10 can be found in U.S. Pat. Nos. 8,388,541; 8,781,555; 8,849,382; 9,521,961; 9,526,440; 9,549,685; 9,636,031; 9,649,048; 9,681,823; 9,999,371; 10,105,121; 10,165,962; 10,238,418; and 10,602,958, each of which is incorporated by reference in its entirety into this application.

[0025] TLS Sensor LED Array 4-13, and in particular FIG. 4, in one embodiment, a TLS sensor ("sensor") 50 may include an LED array 200 including one or more individual LED lamps, e.g., LED lamps 201, 202, 203. The LED array 200 may be disposed on a surface of the sensor 50, e.g., on an upper surface thereof. However, it will be appreciated that one or more LED lamps of the array 200 may be disposed on one or more surfaces of the sensor 50, e.g., on a side surface thereof. In one embodiment, one or more LED lamps of the array 200 may protrude from a surface of the sensor 50. In one embodiment, one or more LED lamps of the array 200 are integrated with the sensor 50 to define a substantially continuous surface with the sensor 50. It will also be appreciated that other visible indicators, e.g., tungsten bulbs, fluorescent lamps, tabs of different colors, etc., may be used in place of or in conjunction with the LED array 200.

[0026] In an embodiment, the LED array 200 may indicate the location of a medical device, such as a catheter 72, relative to the sensor 50. FIGS. 5-8 show a sensor 50 including an LED array 200. As shown in FIG. 5, when the catheter 72 is not in close proximity to the sensor 50, none of the LED lights of the LED array 200 are illuminated. As shown in FIG. 6, when the catheter 72 is in close proximity to the first side 51 of the sensor 50, the first LED light 201 closest to the catheter 72 is illuminated, and the remaining LED lights 202, 203 of the LED array 200 are not illuminated. Similarly, when the catheter 72 is in close proximity to the second side 53 of the sensor 50, the second LED light 203 closest to the catheter 72 is illuminated, and the remaining LED lights 201, 202 of the LED array 200 are not illuminated. As shown in FIG. 7, as the catheter 72 is moved further toward the sensor 50 and the target site substantially at the LED light 202, the additional LED lights 201, 202 of the array 200 may also be illuminated.

[0027] In an embodiment, one or more of the LED lights 201, 202, 203 of the array 200 may display two or more colors to provide a two-dimensional display as opposed to a one-dimensional display, or a binary (on / off) display. For example, each of the LED lights 201, 202, 203 of the array 200 may display green, yellow, and red. The color changes may indicate the degree of proximity of the catheter 72 to each of the LED lights 201, 202, 203 of the array 200. By interpreting the different color changes in the individual LED lights 201, 202, 203 of the array 200, a user can determine the position of the catheter 72 relative to the sensor 50.

[0028] As shown in FIG. 8, in an embodiment, the color change may indicate the degree of proximity of the catheter 72 to the sensor 50 along a horizontal plane substantially parallel to the skin surface of the patient 70 on which the sensor 50 is disposed. For example, when the catheter 72 is in proximity to the sensor 50 substantially defined by Zone A, the LED light 201 may display a green color. When the catheter 72 is in Zone B, the LED light 201 may display a yellow color, and when in Zone C, the LED light 201 may display a red color. In an embodiment, as shown in FIG. 9, the color change may indicate the depth of the catheter 72 to the sensor 50 along a vertical plane substantially perpendicular to the skin surface of the patient 70 on which the sensor 50 is disposed. In an embodiment, as shown in FIG. 10, the color change may indicate the degree of proximity of the catheter 72 to the sensor 50 within the three-dimensional spherical space of each LED light of the array 200.

[0029] It is recognized that any number and order of zones, absolute spacing of the zones, types of colors displayed, and specific information represented by each color may be varied without departing from the spirit of the invention. In one embodiment, each zone may be 5 cm apart, e.g., zone A may represent when catheter 72 is <5 cm from sensor 50, zone B may represent when catheter 72 is 5 cm-10 cm from sensor 50, and zone C may represent when catheter 72 is 10 cm-15 cm from sensor 50. However, it is recognized that each zone may represent a different absolute distance range. In one embodiment, a series of color changes may represent a series of changes in distance, depth, or a combination thereof.

[0030] 11, one or more LED lights of the array 200, such as LED lights 201, 203, 204, may project a symbol, such as an image, an alphanumeric symbol, etc. The symbol may be projected on the surface of the patient 70 proximate to the sensor 50. The symbol may indicate location, distance, depth, combinations thereof, or similar information regarding the catheter 72 relative to the sensor 50. For example, when the catheter position 72A is proximate to a first side of the sensor 50, the first LED light 201 of the array may project an arrow symbol 221 on the surface of the patient 70, where the angle of the arrow may indicate the direction of the catheter 72 relative to the sensor 50, the number of arrows may indicate the distance of the catheter 72 relative to the sensor 50, and the color may indicate the depth of the catheter 72 relative to the sensor 50. 11, a second catheter position 72B is shown proximate to the second side with a symbol 223 projected onto the surface of the patient 70 to indicate location and distance, and further, color may indicate depth. It is recognized that the remaining LED lights of the LED array 200 that do not have a medical device in the immediate vicinity, such as LED light 204, do not project a symbol.

[0031] Thus, each of the LED lights of array 200 may indicate the location, direction, distance, or depth of catheter 72 relative to sensor 50. It will be appreciated that any combination of shapes, symbols, alphanumeric symbols, colors, and the like may be used to indicate any combination of the location, direction, orientation, distance, or depth of catheter 72 relative to sensor 50 without departing from the spirit of the present invention. Additionally, it will be appreciated that the location of more than one medical device may be displayed by LED array 200.

[0032] Advantageously, the LED lights 201, 202, 203 of the array 200 included with the sensor 50 provide a visual indication of the location of the inserted medical device, the catheter 72. Thus, a visual indication is provided to the user without the need for a separate console 20 and display 30, thereby providing a lower cost system. Alternatively, due to the visual indication provided by the sensor 50, such information no longer needs to be displayed on the display 30, thereby eliminating the need to display the real estate. This may provide the display 30 with a clearer, less confusing interface, or may provide different information, or may allow for a smaller, more compact display, or a combination thereof. Furthermore, the user does not need to divert attention from the patient 70 and insertion site to determine whether the distal tip 76A of the catheter 72 is approaching the target location. The user may determine the location of the distal tip 76a of the catheter 72 while manipulating the proximal portion 74 without having to divert attention to the remotely located display 30.

[0033] In an embodiment, the sensor 50 may be used to track the location of the distal tip of the catheter as it is advanced. The sensor may move with the tip, allowing the user to track the location of the tip within the body. Since the location of the medical device is measured as the relative distance between the medical device and the sensor 50, the sensor 50 may also be moved with or prior to the medical device as it is advanced through the vasculature of the patient 70. The LED array 200 may indicate to the user where to move the sensor 50 across the surface of the patient 70 to maintain proximity to the distal tip 76A disposed within the patient 70. Thus, the user may visually determine the location of the medical device as it is advanced.

[0034] In some embodiments, the density of the LED lights in the array 200 may differ from those shown in FIGS. 5-11. As shown in FIG. 12, in some embodiments, the array 200 may include a plurality of LED lights arranged in a matrix arrangement across one or more surfaces of the sensor 50. In some embodiments, the LED array 200 may cover substantially the entire surface of the sensor 50. As the density of the LED lights in the array 200 increases, the detection zone area associated with each LED light of the array 200 is reduced. As such, the resolution of the catheter location, orientation, etc. may be increased. For example, as shown in FIG. 12, the density of the lights in the array 200 may allow only the LED lights directly above the catheter 72 to be illuminated. This provides more detail regarding the location and orientation of the catheter 72 relative to the sensor 50.

[0035] 13-14, in some embodiments, the functionality of the console 20 and display 30 may be included within the sensor 50 to provide the system 10 substantially contained as a single unit system 50A. The surface of the system 50A may include a display 30A similar to the display 30. It will be further appreciated that medical instruments, catheters 72, etc. may be communicatively coupled to the system 50A by either wired or wireless communication modes. In some embodiments, the system 50A may be further coupled to additional devices, such as a virtual reality headset, augmented reality glasses, etc., to further display captured images and information to a user.

[0036] Display 30A may display an image of an underlying catheter 72 within the body of patient 70. Additionally, additional imaging images and information of patient 70 may also be displayed on display 30A to provide an expanded view of medical devices within the body of patient 70 that are positioned beneath system 50A and its sensors. It will be appreciated that imaging images and information of patient 70 may include x-ray, ultrasound, PET, CT, MRI images, combinations thereof, and the like.

[0037] In an embodiment, the system 50A is configured to transform the captured images and information into a three-dimensionally rendered virtual anatomical object by a virtualization algorithm. Further details of the three-dimensional rendering of images can be found in US Patent Application Publication No. 2019 / 0167148; US Patent Application Publication No. 2019 / 0223757; and US Patent Application Publication No. 2019 / 0307419, each of which is incorporated herein by reference in its entirety. The display 30A is configured to display both an image of the medical device and a virtual anatomical object corresponding to a plurality of parts of the patient, which are disposed under the system 50A. The captured image can be linked to the position of the sensor of the system 50A relative to the patient 70. Thus, when the system 50A is moved relative to the patient 70, the displayed virtual anatomical object can also be modified to correspond to the position of the system 50A.

[0038] Thus, the display 30A displays virtual anatomical objects corresponding to the internal portions of the patient 70 located under the system 50A and its sensors. In an embodiment, imaging may be performed and stored in the system 50A before the sensors are implemented. In an embodiment, the images may be continually updated to the display 30A to reflect a dynamic image of the internal portions of the patient 70 as the catheter 72 is advanced. In an embodiment, the system 50A may further include one or more fiduciary points 230 located on the patient 70. Thus, the system 50A may use the fiduciary points 230 to determine the location of the sensors of the system 50A relative to the patient 70. The system 50A may then associate images, information, three-dimensional renderings, such as virtual anatomical structures, to the patient 70.

[0039] In an embodiment, the display 30A may be a touch screen display and may include various buttons 226 displayed thereon to control the functions of the system 10. For example, buttons included on the probe 40 may also be included on the system 50A and may be used by the clinician to quickly invoke a desired mode on the display 30A to assist in the placement procedure. In an embodiment, as shown in FIG. 14, the display may further include graphic elements 224, such as symbols, images, icons, etc., to indicate location, orientation, distance, depth, combinations thereof, etc., when the medical device is not directly under the sensor 50. It will be appreciated that the display 30A may include a light emitting diode (LED) display, an electroluminescent (ELD) display, an electronic ink display, an electronic paper display, a plasma display, a liquid crystal display (LCD), an organic light emitting diode display (OLED), a digital light processing (DLP) display, etc., without departing from the spirit of the present invention.

[0040] The embodiments of the present invention may be embodied in other specific forms without departing from the spirit of the disclosure. The described embodiments are to be considered in all respects merely 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 that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A tracking circuit designed to track movement of a medical device within a body, comprising: a receiving component designed to detect a magnetic field associated with the medical device and generate magnetic field strength data; a processor configured to iteratively calculate position data of the medical device according to the magnetic field strength data; A sensor placed on a skin surface of a patient, the sensor includes a light emitting diode (LED) array; the LED array includes one or more LED lamps; the one or more LED lights of the LED array display a symbol; a sensor, the LED array indicating a degree of proximity of the medical device to the sensor; A medical device tracking system comprising:

2. the LED array includes a first LED light disposed proximate a first side of the sensor, a second LED light disposed proximate a second side of the sensor, and a third LED light disposed proximate a central portion of the sensor; 10. The tracking system of claim 1, wherein one of the first, second, and third LED lights is illuminated when the medical device is in its immediate vicinity.

3. The tracking system of claim 1 or 2, wherein the one or more LED lights of the LED array display two or more colors.

4. The tracking system of claim 3 , wherein the two or more colors indicate one of a distance or a depth of the medical device relative to the sensor.

5. The tracking system of claim 1 , wherein the LED array comprises a matrix of LED lights disposed on a surface above the sensor.

6. 1. A tracking system for tracking a medical device, comprising: the medical instrument includes a magnetic element attached to a tip portion of the medical instrument; the tracking system comprises a sensor configured to track the movement of the medical device; The sensor comprises: a receiving component configured to detect a magnetic field associated with the magnetic element and generate magnetic field strength data; a processor designed to iteratively calculate position data of the tip portion of the medical instrument according to the magnetic field strength data and to simulate insertion of the tip portion of the medical instrument inside a patient's body; a display disposed on a surface above the sensor and configured to display an image from the calculated position data of the tip portion of the medical instrument; the sensor further comprises a light emitting diode (LED) array; the LED array includes one or more LED lamps; the one or more LED lights of the LED array display a symbol; The LED array indicates a degree of proximity of the medical device to the sensor.

7. The tracking system of claim 6 , wherein the display displays a symbol indicating one of the location, orientation, distance, or depth of the medical device when the medical device is in close proximity to the sensor.

8. The tracking system of claim 7 , wherein the symbol comprises one of an alphanumeric symbol, a picture, or an icon.

9. The tracking system of claim 6 , wherein the display displays an image of the medical device when the medical device is positioned under the sensor.

10. 10. The tracking system of claim 6, wherein the display further displays one of additional information or captured images of the patient to provide an expanded view of the medical device located within the patient's body and beneath the sensor.

11. The tracking system of claim 10 , wherein the captured images of the patient include one of an X-ray, an ultrasound, a PET, a CT, or an MRI image of the patient.

12. 11. The tracking system of claim 10, wherein the captured image of the patient is corrected according to a position of the sensor on the patient to correspond to the captured image of a portion of the patient located under the sensor.

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