Catheter tracking and placement system including a light emitting diode array

Abstract

The present invention relates to a catheter tracking and placement system including a light emitting diode array, which is 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 having a display and a TLS sensor. The TLS sensor may be arranged on the surface of the 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 projected images to display information about the position, orientation, distance, or depth of the medical device. The display may be arranged on the upper surface of the TLS sensor and may be configured to show an image of the medical device arranged thereunder, together with additional information and images, thereby providing a stand-alone unit.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 873,778, filed on July 12, 2019, the entire contents of which are incorporated herein. Technical Field

[0003] The present application relates to the field of medical devices, and more particularly to a catheter tracking and placement system including a light emitting diode array. Background Art

[0004] Most catheter placement devices require the various medical devices to be coupled to a separate stand-alone display device, showing information or overlay imaging of the medical device location. Inevitably, the display device is positioned remote from the medical device location and the patient, and requires the user to divide their time between the medical device insertion location and the display device. This is particularly relevant to medical device tracking systems, which require the user to manipulate one or more medical devices at the insertion site on the patient while always keeping an eye on a display device positioned elsewhere. Therefore, there is a need for a system and method for positioning a tip device on or near the patient, and indicating to the user the location of the medical device within the patient. Summary of the invention

[0005] Briefly summarized, embodiments disclosed herein relate to a tracking system configured to track the movement of a medical device. The system includes a tip positioning system ("TLS") sensor that includes an LED array. The LED array can indicate the proximity of the medical device to the TLS sensor. The LED array can provide different colors or projected images to display information about the position, orientation, distance, or depth of the medical device. In an embodiment, a display is arranged on an upper surface of the TLS sensor and is configured to show an image of a medical device arranged thereunder together with additional information and images.

[0006] In one aspect of the present invention, a medical device tracking system is disclosed, comprising: a tracking circuit designed to track the movement of a medical device in the body, the tracking circuit comprising a receiving component and a processor, the receiving component being designed to detect a magnetic field associated with the medical device and generate magnetic field strength data, the processor being designed to iteratively calculate position data of the medical device based on the magnetic field strength data; and a sensor arranged on the skin surface of the patient, the sensor comprising a light emitting diode (LED) array, the LED array comprising one or more LED lights, the LED array indicating the proximity of the medical device to the sensor.

[0007] In some embodiments, the LED array includes a first LED light arranged near a first side of the sensor, a second LED light arranged near a second side of the sensor, and a third LED light arranged near a central portion of the sensor, and wherein one of the first LED light, the second LED light, and the third LED light illuminates when a medical device is approached thereto. One or more LED lights in the LED array display more than one color. More than one color indicates one of a distance or depth of the medical device relative to the sensor. The LED array includes a matrix of LED lights arranged on an upper surface of the sensor.

[0008] A tracking system for tracking a medical device is also disclosed, the medical device including a magnetic element attached to its distal portion, 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; a processor designed to iteratively calculate the position data of the distal portion of the medical device based on the magnetic field strength data, and simulate the insertion of the distal portion of the medical device into the patient's body. The system includes a display arranged on an upper surface of the sensor. The display is configured to depict an image from the calculated position data of the distal portion of the medical device.

[0009] In some embodiments, the display depicts a symbol to indicate one of the position, orientation, distance or depth of the medical device when the medical device is close to the sensor. When the medical device is arranged below the sensor, the display depicts an image of the medical device. The symbol includes one of an alphanumeric symbol, an image or an icon. The display further depicts one of the additional information or imaging of the patient to provide an augmented view (augmented view) of the medical device in the patient and arranged below the sensor. The imaging of the patient includes one of the X-ray, ultrasound, PET, CT or MRI images of the patient. The imaging of the patient is modified according to the position of the sensor on the patient so that the imaging corresponds to a part of the patient arranged below the sensor.

[0010] Also disclosed is a method for tracking a medical device, comprising: positioning a sensor over a target area of ​​a patient, the sensor comprising an LED array of one or more LED lights; inserting the medical device into the patient's vascular system; and indicating the proximity of the medical device to the sensor by illuminating one or more LED lights in the LED array.

[0011] In some embodiments, the proximity of the medical device to the sensor includes one of a distance or a depth of the medical device in three-dimensional space. One or more LED lights in the LED array display more than one color, and the more than one color indicates the proximity of the medical device relative to the sensor. One or more LED lights in the LED array illuminate when the medical device is arranged directly below it. One or more LED lights in the LED array project a symbol onto the surface of the patient, indicating one of the position, direction, distance or depth of the medical device relative to the sensor. The symbol includes one of an alphanumeric symbol, an image or an icon. The LED array is a display configured to provide an image of the medical device when the medical device is arranged below the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more particular description of the present disclosure will be presented by reference to specific embodiments of the present disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0013] Figure 1 is a block diagram depicting various elements of an integrated system for intravascular placement of a catheter according to an example embodiment;

[0014] Figure 2 Patients and Figure 1 Simplified view of a catheter inserted into a patient with the help of an integrated system;

[0015] Figure 3 yes Figure 1 An exemplary console and display for an integrated system of

[0016] Figure 4 is a perspective view of a sensor according to an embodiment;

[0017] Figure 5 is a first plan view of a sensor according to an embodiment;

[0018] Figure 6 is based on Figure 5 A second plan view of a sensor of an embodiment of the present invention;

[0019] Figure 7 is based on Figure 5 A third plan view of a sensor of an embodiment of the present invention;

[0020] Figure 8 is based on Figure 5 A fourth plan view of a sensor of an embodiment of the present invention;

[0021] Fig. 9 is a first side view of a sensor according to an embodiment;

[0022] Fig.10 is based on Fig. 9 A second side view of a sensor of an embodiment of the present invention;

[0023] Fig.11 is a plan view of a sensor according to an embodiment;

[0024] Fig.12 is a plan view of a sensor according to an embodiment;

[0025] Fig.13 is a first plan view of a sensor according to an embodiment; and

[0026] Fig.14 is based on Fig.13 A second plan view of a sensor of an embodiment of the present invention. DETAILED DESCRIPTION

[0027] Reference will now be made to the drawings, wherein like structures will be provided with like reference numerals. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the concepts provided herein, and are neither limiting nor necessarily drawn to scale.

[0028] For the sake of clarity, it will be understood that the word "proximal" refers to a direction relatively close to a clinician using the device described herein, while the word "distal" refers to a direction relatively farther away from the clinician. For example, the end of a catheter placed in a patient's body is considered to be the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. In addition, the words "including", "having" and "with" as used herein (including the claims) should have the same meaning as the word "comprising".

[0029] The terms "upper," "lower," "top," "bottom," "underside," "upper side," etc., also used to describe the present system, are used with reference to the orientation of the illustrated embodiments. The terms "left" and "right" are used consistently throughout the disclosure and are used to describe the structure from the perspective of a user or clinician using the device.

[0030] Assisted catheter placement

[0031] Embodiments generally relate to a catheter placement system, which is configured to accurately place a catheter in the patient's vascular system. In one embodiment, the catheter placement system uses at least two modalities to improve catheter placement accuracy: 1) ultrasound-assisted guidance, for introducing a catheter into the patient's vascular system; and 2) a tip location / navigation system ("TLS"), or a magnetic-based tracking of the catheter tip during its advancement through a curved vascular system path, to detect and facilitate the correction of any tip misalignment during such advancement. The ultrasound guidance and tip location parts of this system according to an embodiment are integrated into a single device for use by a clinician who places a catheter. The integration of these two modalities into a single device simplifies the catheter placement process and results in relatively fast catheter placement. For example, an integrated catheter placement system enables viewing ultrasound and TLS activities from a single display of an integrated system. And, a control (control) located on an ultrasound probe or TLS sensor of an integrated device (which remains in the sterile area of ​​the patient during catheter placement) can be used to control the function of the system, thereby eliminating the need for clinicians to contact the sterile area in order to control the system.

[0032] In another embodiment, a third modality (i.e., ECG signal-based catheter tip guidance) is included in the integrated system to enable the catheter tip to be guided to a desired location about a node of the patient's heart from which the ECG signal originates. This ECG-based positioning assistance is also referred to herein as "tip confirmation."

[0033] The combination of the above three modalities according to one embodiment enables the catheter placement system to facilitate catheter placement within the patient's vasculature with a relatively high level of accuracy, i.e., placing the distal tip of the catheter in a predetermined and desired position. In addition, due to the ECG-based guidance of the catheter tip, correct tip placement can be confirmed without the need for confirmatory X-rays. This in turn reduces the patient's exposure to potentially harmful X-rays, reduces the cost and time involved in transporting patients to and from the X-ray department, reduces expensive and inconvenient catheter re-placement procedures, etc.

[0034] First reference Figure 1 and 2 , which depicts various components of a catheter placement system ("system") generally designated 10, configured in accordance with an example embodiment. As shown, system 10 generally includes a console 20, a display 30, a probe 40, and a sensor 50, each of which will be described in further detail below.

[0035] Figure 2 These components are shown in their overall relationship to a patient 70 during a procedure in which a catheter 72 is placed through a skin insertion site 73 into the patient's vasculature. Figure 2 Shown catheter 72 generally includes a proximal portion 74 that remains outside the patient and a distal portion 76 that resides in the patient's vascular system after placement is completed. System 10 is adopted to finally position the distal tip 76A of catheter 72 in the desired position in the patient's vascular system. In one embodiment, the desired position of catheter distal tip 76A is close to the patient's heart, such as in the lower third (1 / 3) part of the superior vena cava ("SVC"). Of course, system 10 can be adopted to place the catheter distal tip in other positions. Catheter proximal portion 74 further includes a hub 74A, which provides fluid communication between one or more lumens of catheter 72 and one or more extension legs (legs) 74B extending proximally from the hub.

[0036] Figure 3 An example embodiment of the console 20 is shown in FIG. 1 , but it should be understood that the console may take one of a variety of forms. A processor 22 (e.g., including non-volatile memory such as EEPROM) is included in the console 20 for controlling system functions during operation of the system 10, thereby serving as a control processor. A digital controller / analog interface 24 is also included with the console 20 and communicates with both the processor 22 and other system components to manage interfacing between the probe 40, the sensor 50 and other system components.

[0037] The system 10 further includes a port 52 for connecting to sensors 50 and optional components 54 (including printers, storage media, keyboards, etc.). In one embodiment, the port is a USB port, but other port types or combinations of port types can be used for this and other interface connections described herein. A power connection 56 is included with the console 20 to enable an operable connection to an external power source 58. An internal battery 60 may also be used in conjunction with or in lieu of an external power source. Power management circuitry 59 is included with the digital controller / analog interface 24 of the console to regulate power usage and distribution.

[0038] 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 can be separate from the console. As will be seen, the content depicted by the display 30 changes depending on which mode the catheter placement system is in: US, TLS, or ECG tip confirmation in other embodiments. In one embodiment, the console button interface 32 (see Figure 1 , 3) and buttons included on probe 40, TLS sensor 50 or its combination can be used to call the desired mode to display 30 by the clinician immediately, to assist in placing the procedure. Its further details are disclosed in this article. In one embodiment, information from multiple modes (such as TLS and ECG) can be displayed simultaneously. Therefore, the single display 30 of system console 20 can be adopted for ultrasound guidance in entering the patient's vascular system, TLS guidance during catheter advancement through the vascular system and (as in subsequent embodiments) ECG-based confirmation of the catheter distal tip placement of the tubercle of the patient's heart. In one embodiment, display 30 is an LCD device. In one embodiment, display 30 is a touch screen device.

[0039] Figure 1 The probe 40 is shown to include buttons and a memory controller 42 for managing button and probe operations. In one embodiment, the button and memory controller 42 may include non-volatile memory such as EEPROM. The button and memory controller 42 is in operative communication with a probe interface 44 of the console 20, which includes a piezoelectric 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.

[0040] Further details of the catheter placement system 10 can be found in U.S. Pat. No. 8,388,541; U.S. Pat. No. 8,781,555; U.S. Pat. No. 8,849,382; U.S. Pat. No. 9,521,961; U.S. Pat. No. 9,526,440; U.S. Pat. No. 9,549,685; U.S. Pat. No. 9,636,031; U.S. Pat. No. 9,649,048; U.S. Pat. No. 9,681,823; U.S. Pat. No. 9,999,371; U.S. Pat. No. 10,105,121; U.S. Pat. No. 10,165,962; U.S. Pat. No. 10,238,418 and U.S. Pat. No. 10,602,958, each of which is incorporated herein by reference in its entirety.

[0041] TLS Sensor LED Array

[0042] refer to Figures 4 to 13 And especially Figure 4In an embodiment, a TLS sensor ("sensor") 50 may include an LED array 200 including one or more individual LED lights, such as LED lights 201, 202, 203. The LED array 200 may be arranged on a surface of the sensor 50, such as its upper surface. However, it will be understood that one or more LED lights of the array 200 may be arranged on one or more surfaces of the sensor 50, such as its side surfaces. In an embodiment, one or more LED lights of the array 200 may protrude from the surface of the sensor 50. In an embodiment, one or more LED lights of the array 200 are integrated with the sensor 50 so as to define a surface that is substantially continuous with the sensor 50. It will also be understood that other visual indicators (e.g., tungsten bulbs, fluorescent bulbs, tabs of different colors, etc.) may also be used in place of the LED array 200 or in combination with the LED array 200.

[0043] In an embodiment, the LED array 200 can indicate the position of a medical device (eg, catheter 72 ) relative to the sensor 50 . Figures 5 to 8 A sensor 50 is shown including an LED array 200. Figure 5 As shown in FIG, when no catheter 72 is near the sensor 50, none of the LED lights of the LED array 200 are illuminated. Figure 6 As shown in FIG. 5 , when the conduit 72 approaches the first side 51 of the sensor 50, the first LED lamp 201 closest to the conduit 72 is illuminated, while the remaining LED lamps 202 and 203 of the LED array 200 are not illuminated. Similarly, when the conduit 72 approaches the second side 53 of the sensor 50, the second LED lamp 203 closest to the conduit 72 is illuminated, while the remaining LED lamps 201 and 202 of the LED array 200 are not illuminated. Figure 7 As shown in , when the catheter 72 moves further toward the sensor 50 and the target area is substantially at the LED light 202, additional LED lights 201, 202 of the array 200 may also be illuminated.

[0044] In an embodiment, one or more LED lights 201, 202, 203 of the array 200 may display more than one color to provide a two-dimensional indication, as opposed to a one-dimensional indication or a binary (on / off) indication. 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 proximity of the catheter 72 relative to each of the LED lights 201, 202, 203 of the array 200. By interpreting the different color changes of each of the LED lights 201, 202, 203 of the array 200, the user may determine the position of the catheter 72 relative to the sensor 50.

[0045] like Figure 8 As shown in , in embodiments, the color change can indicate the proximity of the catheter 72 relative to the sensor 50 along a horizontal plane that is substantially parallel to the skin surface of the patient 70 on which the sensor 50 is disposed. For example, when the catheter 72 is within the proximity of the sensor 50 substantially defined by the area A, the LED light 201 can display green. When the catheter 72 is within the area B, the LED light 201 can display yellow, and when in the area C, it can be red. In embodiments, as shown in FIG. Fig. 9 As shown in , the color change can indicate the depth of the catheter 72 relative to the sensor 50 along a vertical plane that is substantially orthogonal to the skin surface of the patient 70 on which the sensor 50 is disposed. Fig.10 As shown in , the color change can indicate the proximity of the catheter 72 relative to the sensor 50 within the three-dimensional spherical space of each LED light of the array 200.

[0046] It will be understood that any number and order of regions, the absolute spacing of regions, the type of colors displayed, and the specific information represented by each color may be changed without departing from the spirit of the invention. In an embodiment, each region may represent an interval of 5 cm, for example, region A is when the catheter 72 is <5 cm from the sensor 50, region B is when the catheter 72 is between 5 cm and 10 cm from the sensor 50, and region C is when the catheter 72 is between 10 cm and 15 cm from the sensor 50. However, it will be understood that each region may represent a different absolute distance range. In an embodiment, a continuum of color changes may indicate a continuum of changes in distance, depth, or a combination thereof.

[0047] In the implementation scheme, Fig.11 As shown in , one or more LED lights (e.g., LED lights 201, 203, 204) of array 200 can project symbols, such as images, alphanumeric symbols, etc. The symbol can be projected onto a surface of patient 70 near sensor 50. The symbol can indicate the position, distance, depth, a combination thereof, or the like of catheter 72 relative to sensor 50. For example, when catheter position 72A is near a first side of sensor 50, first LED light 201 of the array can project an arrow symbol 221 onto the surface of patient 70, the angle of the arrow can indicate the direction of catheter 72 relative to sensor 50, the number of arrows can indicate the distance of catheter 72 relative to sensor 50, and the color can indicate the depth of catheter 72 relative to sensor 50. As also shown in Fig.11In the further example shown in FIG. 2 , the second catheter position 72B is shown near the second side, where the symbol 223 projected onto the surface of the patient 70 indicates the position and distance, and further the color may indicate the depth. It will be understood that for the remaining LED lights of the LED array 200 that have no medical device near them (e.g., LED light 204), no symbol will be projected.

[0048] Accordingly, each LED light of array 200 may indicate the position, direction, distance, depth of catheter 72 relative to sensor 50. It will be appreciated that any combination of shapes, symbols, alphanumeric symbols, colors, etc. may be used to indicate any combination of the position, direction, orientation, distance, or depth of catheter 72 relative to sensor 50 without departing from the spirit of the present invention. Further, it will be appreciated that the position of more than one medical device may be displayed by LED array 200.

[0049] Advantageously, the LED lights 201, 202, 203 of the array 200 included with the sensor 50 provide a visual indication of the position of the inserted medical device (catheter 72). Accordingly, the 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, with the visual indication provided by the sensor 50, it is no longer necessary to display such information on the display 30, thereby freeing up display space (real estate). This provides a cleaner, less confusing interface on the display 30, or allows different information to be provided, or allows a smaller, more compact display, or a combination thereof. Further, the user does not have to divert their attention from the patient 70 and the insertion site in order to determine whether the distal tip 76A of the catheter 72 is approaching the target location. The user can determine the position of the distal tip 76A of the catheter 72 while manipulating the proximal portion 74 without having to divert their attention to the display 30 located at a distance.

[0050] In an embodiment, the sensor 50 can be used to track the position of the distal tip of the catheter when the catheter is advanced. The sensor can move together with the tip, so the user can track its position in the body. Since the position of the medical device is measured as the relative distance between the medical device and the sensor 50, when the medical device is advanced in the vascular system of the patient 70, the sensor 50 can also move together with the medical device or the head of the medical device. The LED array 200 can indicate to the user where to move the sensor 50 across the surface of the patient 70, so as to maintain the proximity with the distal tip 76A arranged in the patient 70. Accordingly, when the medical device is advanced, the user can visually determine the position of the medical device.

[0051] In an embodiment, the density of LED lamps within array 200 can be as high as Figures 5 to 11 The differences are shown in Fig.12 As shown in , in embodiments, array 200 may include a plurality of LED lights arranged in a matrix across one or more surfaces of sensor 50. In embodiments, LED array 200 may substantially cover the entire surface of sensor 50. As the density of LED lights within array 200 increases, the detection area associated with each LED light of array 200 decreases. In this way, the resolution of catheter position, orientation, etc. may be increased. For example, as Fig.12 As shown in FIG. 2 , the density of lights in array 200 allows only the LED lights directly above catheter 72 to be illuminated. This provides more detail of the location and orientation of catheter 72 with respect to sensor 50.

[0052] like Figures 13 to 14 As shown in , in an embodiment, the functionality of the console 20 and the display 30 may be included within the sensor 50 to provide a system 10 that is substantially comprised as a single unit system 50A. The surface of the system 50A may include a display 30A similar to the display 30. Further, it will be understood that medical devices, catheters 72, etc. may be communicatively coupled to the system 50A via a wired communication mode or a wireless communication mode. In an embodiment, the system 50A may be further coupled to additional devices such as a virtual reality headset, augmented reality glasses, etc. to further display imaging and information to the user.

[0053] Display 30A may show an image of catheter 72 disposed thereunder within patient 70. Further, additional imaging and information of patient 70 may also be shown on display 30A to provide an enhanced view of the medical devices disposed beneath system 50A and its sensors within patient 70. It will be appreciated that the imaging and information of patient 70 may include X-ray, ultrasound, PET, CT, MRI images, combinations thereof, and the like.

[0054] In an embodiment, system 50A is configured to utilize a virtualization algorithm to convert imaging and information into an object of virtual anatomy presented in three dimensions. Further detailed information of the three-dimensional presentation of images can be found in U.S. Patent Publication No. 2019 / 0167148, U.S. Patent Publication No. 2019 / 0223757 and U.S. Patent Publication No. 2019 / 0307419, each of which is incorporated by reference into the present application as a whole. Display 30A is configured to display both the image of medical equipment and the object of virtual anatomy corresponding to the part of the patient arranged below system 50A. Imaging can be associated with the position of the sensor of system 50A relative to patient 70. Accordingly, when system 50A moves about patient 70, the object of virtual anatomy displayed can also be modified to correspond to the position of system 50A.

[0055] Thus, the display 30A displays an object of virtual anatomy corresponding to the internal portion of the patient 70 disposed below the system 50A and its sensors. In an embodiment, imaging may be performed before the sensors are implemented and saved to the system 50A. In an embodiment, as the catheter 72 is advanced, the image may be continuously updated to the display 30A to reflect a dynamic image of the interior of the patient 70. In an embodiment, the system 50A may further include one or more fiduciary points 230 disposed on the patient 70. Accordingly, the system 50A may use the fiduciary points 230 to determine the position of the sensors of the system 50A relative to the patient 70. The system 50A may then anchor images, information, three-dimensional presentations of virtual anatomy, etc. to the patient 70.

[0056] In an embodiment, display 30A may be a touch screen display and include various buttons 226 displayed thereon for controlling the functions of system 10. For example, buttons included on probe 40 may also be included on system 50A and may be used by a clinician to immediately call up a desired mode to display 30A to assist in the placement procedure. Fig.14 As shown in , the display may further include graphical elements 224 such as symbols, images, icons, etc. to depict the position, orientation, distance, depth, combination thereof, etc. when the medical device is not directly under the sensor 50. It will be understood 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 display (DLP), etc. without departing from the spirit of the present invention.

[0057] Without departing from the spirit of the present disclosure, embodiments of the present invention may be embodied in other specific forms. The described embodiments should be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the embodiments is indicated by the appended claims rather than the preceding description. All changes falling within the equivalent meanings and scopes of the claims should be included within their scope.

Claims

1. A medical device tracking system, comprising: A tracking circuit designed to track movement of a medical device within a patient's body, the tracking circuit comprising: a receiving component configured to detect a magnetic field associated with the medical device and generate magnetic field strength data; and a processor configured to iteratively calculate position data of the medical device based on the magnetic field strength data; and A sensor comprising a housing designed to be positioned on the chest of the patient and to remain stationary as the medical device moves within the patient from a skin insertion site to a target area, the sensor comprising an LED array comprising one or more LED lights, the housing of the sensor having a lower surface designed to contact the skin surface of the patient, a first LED light of the LED array projecting an arrow symbol onto the surface of the patient, the arrow symbol indicating the proximity of the medical device to the sensor.

2. The tracking system of claim 1 , wherein the first LED light is arranged near a first side of the sensor, the second LED light is arranged near a second side of the sensor, and the third LED light is arranged near a center portion of the sensor, and wherein one or more of the first LED light, the second LED light, and the third LED light are illuminated when the medical device is close thereto.

3. The tracking system of claim 1, wherein the one or more LED lights in the LED array display more than one color. 4 . The tracking system of claim 3 , wherein the more than one color indicates 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 arranged on an upper surface of the sensor.

6. The tracking system of claim 1 further comprising a projected alphanumeric symbol, and wherein one or both of the alphanumeric symbol or the arrow symbol are configured to indicate one or more of a position, direction, distance, or depth of the medical device relative to the sensor.

7. The tracking system of claim 1, further comprising projecting a graphic symbol, image, or icon.

8. The tracking system of claim 2, wherein the second LED light projects a second symbol on the surface of the patient.

Images