Systems and methods for medical device tracking

Abstract

A guidance system for guiding insertion of a medical device toward a target within target area a patient utilizes ultrasound or other suitable technology. The guidance system can include a device guidance module (e.g., an ultrasound probe) for producing target data of the target area. The device guidance module provides sensory feedback including visual, haptic and / or audio feedback based on a determined position of the medical device. One or more sensors detect a magnetic field generated by the medical device. Providing the sensory feedback may include adjusting a variable characteristic of the sensory feedback based on determining a variable position of the medical device. The system may include a processor that can receive magnetic field data sensed by the at-least-one sensor to determine the position of the needle. The system specifically omits depicting an image of a target area of the patient on a display.

Description

SYSTEMS AND METHODS FOR MEDICAL DEVICE TRACKINGPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 571,686, filed March 29, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Accessing a patient’s vasculature is common in hospitals and other healthcare settings. For some patients, inserting a needle through the skin into a blood vessel can be complicated and difficult. It is not uncommon for a clinician to attempt accessing the vasculature multiple times until success is achieved. The use of ultrasound imaging to assist in placement of the needle within a blood vessel has made placement of the needle less complicated resulting in better patient outcomes, reduced patient risk and lower healthcare costs. The use of ultrasound imaging typically includes rendering an ultrasound image on a display so that the clinician can see the blood vessel to be accessed. However, the limitations of such ultrasound images can result in the rendered image being less than clear causing the clinician to have to apply close inspection to the ultrasound image in order to find the target blood vessel and in some instances mis-identify another anatomic element shown in the image as the target blood vessel. In recent history, automatic identification of anatomic elements such as the target blood vessel with the image has shown to be as good as or better than visual inspection. As such, the rendering the ultrasound image on the display provides reduced value and in some instances can be a distraction to clinician during a process that requires significant focus at the insertion site of the needle. Furthermore, the clinician may apply significant time to either obtain a clear ultrasound image or identify a target blood vessel in an image that is not clear. In short, rendering the ultrasound image on a display can be disadvantageous and even problematic.

[0003] Disclosed herein are guidance systems, medical devices, and methods that address the foregoing need to reduce the time required to access a target blood vessel and improve the reliability of accessing the target blood vessel by specifically omitting the rendering the ultrasound image on a display.SUMMARY

[0004] Briefly summarized, embodiments described herein are directed to a system for guiding insertion of a medical device into a body of a patient that, according to some embodiments, includes a medical device configured for insertion into a target area of a patient, where the medical device includes a number magnetic elements configured to define a magnetic field. The system further includes a device guidance module configured to obtain target data of the target area, where the device guidance module includes: (i) a head including target devices configured project first signals into the target area and receive second signals from the target area; (ii) a number of sensors configured to detect the magnet field defined by the medical device; and a number of feedback mechanisms coupled with a housing of the device guidance module, where the feedback mechanisms are configured to provide sensory feedback to a user. The device guidance module further includes a console coupled with the target devices, the sensors, and the feedback mechanisms, where the console includes a processor and a memory having logic stored thereon that, when executed by the processor, performs operations of the system.

[0005] The operations include: (i) defining an access pathway for the medical device, the access pathway extending toward the target within the target area; (ii) determining an alignment of the medical device with respect to the access pathway; and (iii) providing sensory feedback that indicates when the medical device is aligned with the access pathway, where the sensory feedback specifically omits a depiction of an image of the target area. Defining the access pathway, according to some embodiments, includes: (i) projecting the first signals into the target area and receiving the second signals from the target area; (ii) converting the second signals into the target data; (iii) identifying the target within the target area based on the target data; and (iv) determining a location of the target with respect to the device guidance module. Determining the alignment of the medical device with respect to the access pathway, according to some embodiments, includes detecting the magnetic field defined by the magnetic elements and determining a three dimensional (3-D) location of the medical device with respect to the access pathway based on the magnetic field.

[0006] In some embodiments, determining the 3-D location of the medical device includes determining when the medical device is disposed within a detectable region of the magnetic field, and the sensory feedback further indicates when the medical device is disposed within a detectable region.

[0007] In some embodiments, determining the 3-D location of the medical device includes determining a longitudinal location of a distal tip of the medical device along the access pathway, and the sensory feedback further indicates when the distal tip is disposed at the target.

[0008] In some embodiments, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of misalignment between the medical device and the access pathway. In some embodiments, the sensory feedback includes a number of variable characteristics, where each variable characteristic has a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude. In some embodiments, providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of misalignment.

[0009] In some embodiments, determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, and providing the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

[0010] In some embodiments, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of lateral misalignment between the medical device and the access pathway. In such embodiments, the at least one variable characteristic includes a first variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the first variable characteristic based on the variable degree of lateral misalignment.

[0011] In some embodiments, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of transverse misalignment between the medical device and the access pathway. In such embodiments, the at least one variable characteristic includes a second variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the second variable characteristic based on the variable degree of transverse misalignment.

[0012] In some embodiments, the number of feedback mechanisms include a number of light sources, where the sensory feedback includes visual sensory feedback emanating fromthe light sources, and where the variable characteristic includes one or more of a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient.

[0013] In some embodiments, the number of feedback mechanisms include a number of haptic transducers, where the sensory feedback includes haptic sensory feedback emanating from the haptic transducers, and where the variable characteristic includes one or more of a vibration magnitude, a vibration frequency, a location of one or more of the haptic transducers within the housing, or a direction of vibration with respect to the housing.

[0014] In some embodiments, the number of feedback mechanisms include a number of audio transducers, where the sensory feedback includes audio sensory feedback emanating from the audio transducers, and where the variable characteristic includes one or more of a pitch, a beeping cycle rate, or a sound level.

[0015] In some embodiments, identifying the target within the target area includes identifying a blood vessel as the target, and in some embodiments, identifying the target within the target area includes identifying the blood vessel as a vein. In some embodiments, the medical device includes a needle configured to access the blood vessel.

[0016] In some embodiments, the magnetic elements include at least one magnetic element is disposed adjacent the distal tip and at least one other magnetic element disposed proximal the at least one magnetic element.

[0017] Also disclosed herein is a method of providing guidance for insertion of a medical device into a body of a patient that, according to some embodiments, includes: (i) defining an access pathway for the medical device, where the access pathway extends toward a target within a target area of the patient; (ii) determining an alignment of the medical device with respect to the access pathway; and (iii) providing, via feedback mechanisms of the device guidance module, sensory feedback including the guidance for insertion of the medical device, where the sensory feedback specifically omits depicting an image of the target area on a display. In accordance with the such embodiments, defining the access pathway includes: (i) projecting, via an device guidance module, first signals into the target area and receiving second signals from the target area; (ii) converting the second signals into target data; (iii) identifying the target within the target area based on the target data; and (iv) determining a location of the target with respect to the device guidance module. Further determining analignment of the medical device with respect to the access pathway, includes detecting, via sensors of the device guidance module, a magnetic field defined by magnetic elements of the medical device; and determining a 3-D location of the medical device with respect to the access pathway based on the magnetic field. In some embodiments of the method, the sensory feedback indicates when the medical device is aligned with the access pathway.

[0018] In some embodiments of the method, determining the 3-D location of the medical device includes determining a longitudinal location of a distal tip of the medical device along the access pathway with respect to the target, and the sensory feedback further indicates when the distal tip is disposed at the target.

[0019] In some embodiments of the method, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of misalignment between the medical device and the access pathway. In such embodiments, the sensory feedback includes a number of variable characteristics, where each variable characteristic has a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude, and where providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of misalignment.

[0020] In some embodiments of the method, determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, and providing the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

[0021] In some embodiments of the method, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of lateral misalignment between the medical device and the access pathway, where the at least one variable characteristic includes a first variable characteristic, and where providing the sensory feedback includes adjusting the magnitude of the first variable characteristic based on the variable degree of lateral misalignment.

[0022] In some embodiments of the method, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of transverse misalignment between the medical device and the access pathway, where the at leastone variable characteristic includes a second variable characteristic, and where providing the sensory feedback includes adjusting the magnitude of the second variable characteristic based on the variable degree of transverse misalignment.

[0023] In some embodiments of the method, the number of feedback mechanisms include a number of light sources, where the sensory feedback includes visual sensory feedback emanating from the light sources, and where the variable characteristic includes one or more of a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient.

[0024] In some embodiments of the method, the number of feedback mechanisms include a number of haptic transducers, where the sensory feedback includes haptic sensory feedback emanating from the haptic transducers, and where the variable characteristic includes one or more of a vibration magnitude or a vibration frequency.

[0025] In some embodiments of the method, the number of feedback mechanisms include a number of audio transducers, where the sensory feedback includes audio sensory feedback emanating from the audio transducers, and where the variable characteristic includes one or more of a pitch, a beeping cycle rate, or a sound level.

[0026] These and other features of 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 embodiments of the invention as set forth hereinafter.DRAWINGS

[0027] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0028] FIG. 1 illustrates a device guidance system including a device guidance system and a medical device, according to some embodiments;

[0029] FIG. 2 is a block diagram of a console of the device guidance system of FIG. 1, according to some embodiments;

[0030] FIG. 3 illustrates a front view the device guidance system module including the components and features of an identification subsystem of the device guidance system of FIG. 1, according to some embodiments;

[0031] FIG. 4A illustrates an exemplary embodiment of a device tracking subsystem of the device guidance system including a front view of the device guidance system module in use with a patient specifically showing a lateral alignment direction of the medical device, according to some embodiments;

[0032] FIG. 4B is a left side view of the device guidance system module in use with the patient illustrating a transverse alignment direction and a longitudinal direction of the medical device, according to some embodiments;

[0033] FIG. 4C is the left side view of the device guidance system module of FIG. 4B illustrating longitudinal displacement of the medical device, according to some embodiments;

[0034] FIG. 5A illustrates a first exemplary embodiment of a sensory feedback subsystem of the device guidance system of FIG. 1, where feedback mechanism devices include illuminating devices, according to some embodiments;

[0035] FIG. 5B illustrates a second exemplary embodiment of the sensory feedback subsystem where the feedback mechanism devices include haptic devices, according to some embodiments;

[0036] FIG. 5C illustrates a third exemplary embodiment of the sensory feedback subsystem where the feedback mechanism devices include audio devices, according to some embodiments; and

[0037] FIG. 6 is a block diagram of an exemplary method of providing guidance to a user during insertion of the medical device into the patient, according to some embodiments.DESCRIPTION

[0038] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of theconcepts provided herein. It should also be understood that a particular embodiment disclosed herein could have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0039] Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.

[0040] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0041] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a medical device disclosed herein includes a portion of the medical device intended to be near a clinician when the medical device is used on a patient. Likewise, a “proximal length” of, for example, the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of, for example, the medical device includes an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the medical device can include the proximal end of the medical device; however, the proximal portion, the proximal end portion, or the proximal length of the medical device need not include the proximal end of the medical device. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, orthe proximal length of the medical device is not a terminal portion or terminal length of the medical device.

[0042] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a medical device disclosed herein includes a portion of the medical device intended to be near or in a patient when the medical device is used on the patient. Likewise, a “distal length” of, for example, the medical device includes a length of the medical device intended to be near or in the patient when the medical device is used on the patient. A “distal end” of, for example, the medical device includes an end of the medical device intended to be near or in the patient when the medical device is used on the patient. The distal portion, the distal end portion, or the distal length of the medical device can include the distal end of the medical device; however, the distal portion, the distal end portion, or the distal length of the medical device need not include the distal end of the medical device. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the medical device is not a terminal portion or terminal length of the medical device.

[0043] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0044] Target blood vessel identification and medical device tracking and guidance is described for various instruments, such as catheters, stylets, and needles, among the following U.S. patents and U.S. published applications, each of which is incorporated by reference in its entirety into this application: U.S. Patent Nos. 9,649,048; 9,636,031; 9,554,716; 9,521,9619,492,097; 9,456,766; 8,849,382; 8,781,555; 8,388,541; 10,751,509; 10,524,694; 11,020,563; 11,663,170; and 11,759,166, and U.S. Pub. App. Nos. 2022-0330922; 2023- 0138970; 2023-0439748; 2023-0147164; 2022-0172354; and 2022-0160434.

[0045] As set forth above, there is an ongoing need to improve guidance for medical devices including at the human interfaces between guidance systems and the medical devices guided thereby and avoid distraction. Disclosed herein are guidance systems, medical devices, and methods that address the foregoing need to improve guidance for medical devices by omitting the depiction of an image of a target area of the patient on a display.

[0046] FIG. 1 is a general illustration of a device guidance system (DGS) 100 generally directed to assist a clinician during access of a blood vessel (or other location within the patient) which in some instances may be in preparation for the subsequent placement of an intravasculardevice, such as a cannula, catheter, guidewire or any other intravascular device with the vasculature. The DGS 100 generally includes a DGS Module 110 (which may include an ultrasound probe) and a medical device 150. The DGS module 110 includes an identification subsystem (IDSS) 120 for identifying a target 56 within a target area 53 of the patient body, where the target 56 may include an anatomical element, such as a target blood vessel 55 for example. The DGS module 110 further includes a device tracking subsystem (DTSS) 130 for tracking a 3-D location of the medical device 150 in relation to the target 56, and the DGS module 110 further includes a sensory feedback subsystem (SFSS) 140 for providing sensory feedback (i.e., notification) to the user (e.g., a medical clinician) during placement of the medical device 150 at the target 56. As shown, the IDSS 120, the DTSS 130, and the SFSS 140 are contained within a housing 111 of the DGS module 110 along with a console 115. The DGS module 110 may be a hand-held unit configured to engage (i.e., contact) a skin surface 51 of a patient 50 as shown in FIG. 1. The medical device 150 (e.g., a needle as shown) is configured to access a target 56, such as the target blood vessel 55. The IDSS 120 is configured to identify the target 56, determine a location of the target 56 within the target area 53, and define an access pathway 57 extending between the target 56 and an insertion site 52 at the skin surface 51. The DTSS 130 is configured to track the 3-D location of the medical device 150 with respect to the access pathway 57 and along the access pathway 57 during positioning, orienting and advancing of the medical device 150. The SFSS 140 is configured to provide sensory feedback to the user so that the user can advance the medical device 150 along the access pathway 57 so as to access the target 56. Note that the DGS 100 can be configured in one of a variety of ways in addition to what is shown and described herein. The DGS module 110 may further include the control buttons 113 for controlling the DGS module 110.

[0047] FIG. 2 is a block diagram of the console 115 and other components associated with the DGS module 110. It can be appreciated that the console 115 can take one of a variety of forms. A processor 210 and memory 220 may be combined in a single device, such as an EEPROM, for example. The processor 210 and memory 220 control system function during operation of the DGS module 110. The memory 220 includes IDSS logic 221, DTSS logic 222, and SFSS logic 223.

[0048] A digital controller / analog interface 230 is also included with the console 115 and is in communication with both the processor 210 and other system components. An IDSS interface 231 provides operatively coupling between the digital controller / analog interface 230and the target devices 241. A DTSS interface 232 provides operatively coupling between the digital controller / analog interface 230 and the tracking devices 242. A SFSS interface 233 provides operatively coupling between the digital controller / analog interface 230 and the feedback mechanism devices 243. The target devices 241, the tracking devices 242, and the feedback mechanism devices 243 are described in the further detail below.

[0049] The console 115 can further include a plurality of ports 215 for connection with optional components 216 including a printer, storage media, keyboard, etc. The ports 215 in one embodiment may include USB ports, though other port types or a combination of port types can be used for this and the other interface connections described herein. In certain embodiments, the console 115 may include a wireless module 214 to enable wireless communication over a network.

[0050] A power connection 252 may be included with the console 115 to enable operable connection to an external power supply 253. An internal power supply 254 (e.g., a battery) can also be employed, either with or exclusive of the external power supply 253. Power management circuitry 251 is included with the digital controller / analog interface 230 of the console 115 to regulate power use and distribution.

[0051] FIG. 3 illustrates a front view of the DGS module 110 including the components and features of the IDSS 120, according to a variety of embodiments. The IDSS 120 may be employed in connection with target data (e.g., ultrasound data) pertaining to a blood vessel, such as a vein, in preparation for insertion of the medical device 150 into the vasculature. The target data can enable providing real time guidance to the user, and thereby, assist in reducing complications typically associated with such introduction, including inadvertent arterial puncture, hematoma, pneumothorax, etc.

[0052] The DGS module 110 includes a head 313 that houses the target devices 241 which may include ultrasonic transducers 310 (e.g., piezoelectric or similar functioning devices) for producing ultrasonic pulses (signals) and for receiving echoes (reflected ultrasound signals) after reflection by the patient’s body when the head 313 is placed against the patient’s skin 51. The target devices 241 may, in addition to or alternatively, include infrared devices 320 such as an infrared light source 320A and a light detector 320B. The infrared light source 320A is configured to project infrared light into the patient through the skin surface 51 and the light detector 320B is configured to detect infrared light signals that emanate from anatomicalelements beneath the skin surface 51 such that target data pertaining to the anatomical elements may be determined from the infrared light signals. As such, in one embodiment a clinician employs the IDSS 120 portion of the DGS module 110 to determine a suitable insertion site 52 and define the access pathway 57 (see FIG. 1).

[0053] The IDSS logic 221 in conjunction with the target devices 241 is generally configured to define the access pathway 57 for the medical device 150 to access the target 56 such as a target blood vessel 55. The IDSS logic 221 is configured to project pules or signals (e.g., ultrasound pulses / signals) into the target area 53 and receive signals emanating from anatomical elements within the target area 53 and converting the received signals into target data. Defining the access pathway 57 may include identifying the target 56 (i.e., the target blood vessel 55) from among other anatomical elements within the target area 53, such as an artery 304 or a nerve bundle 305 based on the target data (e.g., ultrasound data). The IDSS logic 221 may be configured to determine that the target blood vessel 55 is vein vs. an artery based on the target data, which may include doppler ultrasound data. The IDSS logic 221 is also configured to determine a location of the target 56 with respect to the DGS module 110 or more specifically the head 313. The location may include a lateral location of the target 56 with respect to a longitudinal axis 112 of the DGS module 110, e.g., the IDSS logic 221 may determine a lateral offset or misalignment 331 of the target 56 with respect to the longitudinal axis 112. The location may also include a depth 333 of the target 56 with respect to the DGS module 110, e.g., the IDSS logic 221 may determine the depth 333 with respect to the skin surface 51. The IDSS logic 221 may then define the access pathway 57 based at least in part on the determined lateral location and depth of the target 56. In some embodiments, the IDSS logic 221 may include a preferred or desired angle of insertion 157 (see FIG. 1) stored in the memory 220. As such, the IDSS logic 221 may then define the access pathway 57 based on the lateral location and depth of the target 56 along with the angle of insertion 157. The angle of insertion 157 is an angle between the longitudinal axis 112 of the DGS module 110 and a longitudinal axis 155 of the access pathway 57.

[0054] The IDSS logic 221 may be configured to determine a size of the target blood vessel 55. As the target 56 is a location within the target blood vessel 55, the IDSS logic 221 may define a size or cross section of the target 56 in accordance with a size of the target blood vessel 55. For example, a relatively large cross-sectional area of the target 56 may be defined based on relatively large target blood vessel 55. Conversely, a relatively small cross-sectionalarea of the target 56 may be defined based on relatively small target blood vessel 55. Further, a cross-sectional area of the access pathway 57 may be defined based on the cross-sectional area of the target 56.

[0055] The IDSS logic 221 may include an artificial intelligence (Al) module that may be employed for identifying the target blood vessel 55 including identifying the target blood vessel 55 as an artery or a vein or otherwise distinguishing a vein from an artery. The Al module may be configured to receive and process training data sets that include data pertaining to differentiating characteristics which may comprise any or all of a size or diameter of the blood vessel, position of the blood vessel relative to a skin surface or other body structure, relative position between adjacent blood vessels, motion or changing diameter of blood vessel in response pressure pulsing within the blood vessel, cross-section shape of the blood vessel, cross-section shape of the blood vessel in response to applied pressure, or wall thickness of the blood vessel.

[0056] In one example, processing of the Al module may include generation of a machine-learning (ML) model and training of the ML model using received one or more training data sets. The ML model may then be deployed to score signals (e.g., ultrasound signals) and / or pressure pulse data to detect and / or identify particular targets, such as blood vessels and more specifically, veins or arteries. In some embodiments, the trained ML model may be stored in the memory 220.

[0057] The Al module may apply algorithms or other logic operations to define a set of thresholds for any or all of the differentiating characteristics. The Al module may define an initial default set of thresholds via an initial training set of Al data. The IDSS logic 221 may apply default thresholds defined by the Al module in identifying the target blood vessel 55 including distinguishing an artery from a vein. In some instances, the Al module may incorporate additional Al data to add precision to the set of thresholds or otherwise redefine a set of thresholds. In some instance, the Al module may define additional differentiating characteristics together with associated thresholds. In some embodiments, the IDSS logic 221 may store, monitor, and / or analyze data pertaining to confidence levels generated during comparison of real-time data with a set of thresholds. The IDSS logic 221 may then instigate a process of incorporating additional data into the Al process and generate a new and improved set of thresholds.

[0058] FIGS. 4A-4C illustrate various views of the DGS module 110 including the components and features of the DTSS 130, according to some of embodiments. FIG. 4A is a front view of the DGS module 110 in use with a patient as similarly shown in FIG. 3. The target 56 including the target blood vessel 55 is shown within the target area 53. The medical device 150 is shown in front of the DGS module 110 with the distal tip 151 disposed at the insertion site 52. The DTSS 130 includes the tracking devices 242 which may include a number of sensors 420 (e.g., magnetometers) disposed within the housing 111 that are configured to detect a magnetic field defined by magnetic elements 420 of the medical device 150. In some embodiments, the magnetic elements 420 may include a first magnetic element 420A disposed adjacent the distal tip 151 of the medical device 150 and at least a second magnetic element 420A disposed proximal of the first magnetic element 420A such as adjacent a proximal end of the medical device 150. The magnetic elements 410 may include magnetized portions of the medical device 150, or permanent magnets coupled with the medical device 150, for example. The magnetic elements 410 are arranged (e.g., spaced away from each other) so that the magnetic field can define a 3-D location of the medical device 150 and an orientation of the medical device 150, where the orientation is distinct from the 3-D location. The sensors 420 are configured (e.g., arranged and oriented within the housing 111) so that the sensors 420 can determine from the magnetic field the 3-D location and the orientation of the medical device 150 with respect to the DGS module 110. One portion of the 3-D location is a lateral location (i.e., a left to right location) of the medical device 150 with respect to the DGS module 110.

[0059] FIG. 4B is a left side view of the DGS module 110 in use with the patient. The access pathway 57 is shown extending from the insertion site 52 to the target 56, where the target 56 is disposed within the target blood vessel 55. The access pathway 57 also includes an extended portion 57A extending externally way from the insertion site 52 along the longitudinal axis 155 of the access pathway 57. The medical device 150 is shown within the extended portion 57A of the access pathway 57, and as such, the medical device 150 is in alignment the access pathway 57. FIG. 4B defines a longitudinal direction that is parallel with the longitudinal axis 155 and perpendicular to the lateral direction defined in FIG. 4A. FIG. 4B further defines a transverse direction that is perpendicular to the lateral direction and the longitudinal direction.

[0060] The DTSS logic 222 is configured to receive and process electrical signal data from the sensors 410 and determine therefrom the location of the medical device 150 with respect to the DGS module 110 in the lateral and transverse directions. In some embodiments,the DTSS logic 222 may determine when the medical device is disposed within a detectable region of the magnetic field.

[0061] As the IDSS logic 221 defines the access pathway 57 with respect to the DGS module 110 and the DTSS logic 222 determines the location of the medical device 150 with respect to the DGS module 110, the DTSS logic 222 may further determine the location of the medical device 150 with respect to the access pathway 57 in the lateral and transverse directions. As such, the DTSS logic 222 is configured to determine when the medical device 150 is disposed within the access pathway 57 (i.e., when the medical device 150 is disposed within cross-sectional area the access pathway 57) including the extended portion 57A thereof.

[0062] The DTSS logic 222 may be further configured to determine a variable degree of mis-location or mis-alignment of the medical device 150 with respect to the access pathway 57. In other words, the DTSS logic 222 may determine a relative distance between the medical device 150 and the access pathway 57 in the each of the lateral and transverse directions. Accordingly, the DTSS logic 222 may determine that the medical device 150 is laterally misaligned from the access pathway 57 (including the extended portion 57A) to right of the access pathway 57 and / or to the left of the access pathway 57, including a variable degree (or distance) of misalignment to the right and / or left of the access pathway 57. Similarly, the DTSS logic 222 may determine that the medical device is transversely misaligned from the access pathway 57 (including the extended portion 57A) above of the access pathway 57 and / or below the access pathway 57, including a variable degree (or distance) of misalignment above and / or below the access pathway 57. By way of summary, the DTSS logic 222 may determine when the medical device 150 is relatively near to, far from the access pathway 57, or at any location therebetween in each the lateral and transverse directions.

[0063] FIG. 4C illustrates the left side view of the DGS module 110 similar to FIG. 4B, where the medical device 150 is longitudinally displaced along the access pathway 57 in relation the position of the medical device 150 illustrated in FIG. 4B. The medical device 150 is displaced toward the target 56 such that the distal tip 151 is disposed at the target 56 (i.e., within the cross-sectional area of the target 56). The DTSS logic 222 tracks the longitudinal location of the medical device 150 along the access pathway57 as the medical device 150 inserted through the skin and into the target blood vessel 55. More specifically, the DTSS logic 222 tracks the longitudinal location of the distal tip 151 and determines when the distal tip arrives at the target 56. Tracking the longitudinal location of the distal tip 151 may includetracking the depth the distal tip 151 and determining when the distal tip arrives at the target 56, may include determining when the depth distal tip a 151 is equal to the depth of the target 56. As such, the DTSS logic 222 tracks the longitudinal location of the magnetic element 420A via the magnetic field. The DTSS logic 222 is configured to determine when the distal tip 151 is disposed at the target 56.

[0064] The DTSS logic 222 may be further configured to determine a relative distance between the distal tip 151 and the target 56 during advancement of the medical device 150 along the access pathway 57. In other words, the DTSS logic 222 may determine when the distal tip 151 is relatively near to, far from the target 56 or at any location therebetween in longitudinal direction.

[0065] FIGS. 5A-5C illustrate various exemplary embodiments of the SFSS 140. The SFSS 140 includes the SFSS logic 223 operative coupled with the feedback mechanism devices 243 such that sensory feedback (e.g., guidance) is provided to the user during positioning of the medical device 150 outside the patient 50 and during insertion of the medical device 150 into the patient 50. The feedback mechanism devices 243 may include light sources (i.e., illuminating devices), haptic transducers, and / or audio transducers including any combination thereof.

[0066] Each of the feedback mechanism devices 243 may change state, as caused by the SFSS logic 223, to indicate a positional status of the medical device 150 during use, according to some embodiments. For example, the feedback mechanism devices 243 be activated or deactivated. The feedback mechanism devices 243 may be (i) disposed in one state to indicate one location of the medical device 150, and (ii) disposed in another state to indicate another location of the medical device 150. Further, in some embodiments, the feedback mechanism devices 243 may be (i) variably transitioned between the one state and the other state to indicate a variable location of the medical device 150 between the one location and the other location.

[0067] FIG. 5 A illustrates an exemplary embodiment of the SFSS 140, where the feedback mechanism devices 243 include illuminating devices 540. FIG. 5 A illustrates the front side 502 of the DGS module 110 and the target 56 with the access pathway 57 leading toward the target 56. FIG. 5A further illustrates a Cartesian coordinate system 505 having a lateral axis 510, a transverse axis 520, and a longitudinal axis 530 which are mutuallyperpendicular to each other with the origin of the Cartesian coordinate system 505 located at target 56. The lateral axis 510 includes a right direction 511 and a left direction 512. The transvers axis 520 includes an upward direction 521 and a downward direction 522. The longitudinal axis 530 includes an outward direction 531 extending outward from the origin along the access pathway 57. During use, the medical device 150 can be positioned at any location within the Cartesian coordinate system 505 and the illuminating devices 540 are configured to provide sensory feedback to the user regarding the location of the medical device 150 within the Cartesian coordinate system 505. The SFSS 140 may be configured to provide sensory feedback to the user indicating when the medical device 150 is disposed within the detectable region of the magnetic field.

[0068] The illuminating devices (i.e., light sources) 540 are generally configured to visual provide sensory feedback to the user regarding the location of the medical device 150 within the Cartesian coordinate system 505 specifically in the right, left, upward, downward, or outward directions with respect to the target 56. In the illustrated exemplary embodiment, the illuminating devices 540 include right direction device 541, a left direction device 542, an upward direction device 543, a downward direction device 544, and an outward direction device that correspond to the right direction 511, the left direction 512, the upward direction 521, the downward direction 522, and the outward direction 531, respectively. The illuminating devices 540 may also include target illuminating device 546 that corresponds to the target 56. The illuminating devices 540 may be LEDs or any other suitable illuminating device configured to provide visual sensory feedback. The illustrated number and positioning of the illuminating devices 540 accords with one embodiment. Other embodiments may include a different number of illuminating devices 540 and different positioning thereof.

[0069] The SFSS logic 223 is configured to control the illumination of the illuminating devices 540 so as to provide visual sensory feedback based on the location of the medical device 150 within the Cartesian coordinate system 505 so that the user can adjust the location of the medical device 150 with respect to the target 56 or the access pathway based on the visual sensory feedback provide by the illuminating devices 540. For example, the SFSS logic 223 may illuminate the right direction device 541 when the medical device 150 is located away from the access pathway 57 in the right direction 511. Similarly, the SFSS logic 223 may illuminate the left direction device 542, the upward direction device 543, or the downward direction device 544 when the when the medical device 150 is located away from the accesspathway 57 in the left direction 511, the upward direction 521 or the downward direction 522, respectively. In this way, the user know based on the illumination of the illuminating devices 540 which direction the user may adjust the location of the medical device 150 toward the access pathway 57. In some embodiments, the SFSS logic 223 may deactivate (i.e., turn off the illumination of) all of the right, left, upward, and downward direction devices 541-544, when the medical device 150 is disposed within (i.e., aligned with) the access pathway 57. As such, when the right, left, upward, and downward direction devices 541-544 are deactivated, the user may feel confident that insertion of the medical device 150 along the longitudinal axis of the medical device 150 will result in positioning the distal tip 151 at the target 56. Similarly, during insertion of the medical device 150, the re-illumination of any one of the right, left, upward, and downward direction devices 541-544 may indicate that the medical device 150 out of alignment with the access pathway 57. Alternatively or in addition to activating and deactivating one or more of the direction devices 541-544, the SFSS logic 223 change a state of the one or more of the direction devices 541-544, such as a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient, for example.

[0070] In some embodiments, the SFSS logic 223 may illuminate the outward direction device 545 when the medical device 150 is aligned with the access pathway 57 indicating that the distal tip 151 is spaced away from the target 56 along the access pathway 57. In such embodiments, the SFSS logic 223 may maintain illumination of the outward direction device 545 during insertion until the distal tip 151 is disposed within the target 56, at which point the SFSS logic 223 may deactivate the outward direction device 545 indicating that the distal tip 151 is disposed within the target 56. In some embodiments, the SFSS logic 223 may illuminate the target device 546 to indicate that the distal tip 151 is disposed within the target 56.

[0071] In use, the user may place the medical device 150 in proximity to the DGS module 110 (i.e., within the detectable area of the magnetic field) and note the illumination of the illuminating devices 540. Based on the illumination and / or deactivation of the right, left, upward, and downward direction devices 541-544, the user may adjust the position of the medical device 150 until all of the right, left, upward, and downward direction devices 541— 544 are deactivated indicating that the medical device 150 is aligned with the access pathway 57. The user may then insert the medical device 150 into the patient while ensuring that the right, left, upward, and downward direction devices 541-544 remain deactivated. The user maycontinue to insert the medical device 150 into the patient until the outward direction device 545 is deactivated and / or the target device 546 is activated indicating that the distal tip 151 is disposed within the target 56, i.e., that the medical device 150 is successfully placed within the target blood vessel 55.

[0072] In some embodiments, the SFSS 140 may include a number of variable characteristics, where each variable characteristic has a magnitude that can vary between a first magnitude and a second magnitude, and where the second magnitude is different from the first magnitude. In such embodiments, providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of positioning of the medical device 150. In other words, the SFSS 140 may be configured to provide variable sensory feedback to the user in accordance a variable position (i.e., a variable degree of mislocation or mis-alignment) of the medical device 150 with respect to the access pathway 57 and / or the target 56. For example, alternatively or in addition to the SFSS logic 223 activating and deactivating the illuminating devices 540, the SFSS logic 223 may variably illuminate (e.g., adjust brightness of) the illuminating devices 540. For example, the SFSS logic 223 may (i) illuminate the right direction device 541 at a first brightness when the medical device 150 is relatively near the access pathway 57 in the right direction 511 and illuminate the right direction device 541 at a second brightness (e.g., brighter than the first brightness) when the medical device 150 is relatively far from the access pathway 57 in the right direction 511. As such, the right direction device 541 may not only indicate that the medical device 150 misaligned from the access pathway 57 in the right direction 511, but also indicate the degree a misalignment. As such, the user may know if a relatively small or large positional adjustment is necessary to place the medical device 150 in alignment with the access pathway 57 in the right direction 511. The other direction devices 542-544 may also variably indicate misalignment is a similar fashion.

[0073] Similarly, the SFSS logic 223 may variably illuminate the outward direction device 545 to indicate a relative distance of the distal tip 151 from the target 56 as the medical device 150 is advanced along the access pathway 57. Accordingly, the user may know if a relatively small or large insertion displacement is necessary to place the distal tip 151 at the target 56 based on the variable illumination of the outward direction device 545. Of course, variable illumination is only one variable characteristic of the illumination devices 540 of many other variable characteristics that could be employed, such as adjusting, a color, a flashingcycle rate, a pattern, or a location on the housing, for example. In some embodiments, the illumination devices 540 may be configured to project a light signal onto the patient. In such embodiments, the variable characteristic may include adjusting the location of the projected light signal on the patient.

[0074] FIG. 5B illustrates another exemplary embodiment of the SFSS 140, where the feedback mechanism devices 243 include a number (1, 2, 3 or more) of haptic devices 550 disposed within the housing 111 and operatively coupled with the housing 111, such the haptic sensory feedback produced by the haptic devices 550 is received by the hand of the user. FIG. 5B illustrates the front side 502 of the DGS module 110 and the target 56 with the access pathway 57 leading toward the target 56. FIG. 5B further illustrates the Cartesian coordinate system 505 of FIG. 5A. Similar to the illuminating devices 540, the haptic devices 550 are generally configured to provide sensory feedback to the user regarding the location of the medical device 150 within Cartesian coordinate system 505 specifically in the right, left, upward, downward, or outward directions with respect to the access pathway 57 and the target 56. The haptic devices 550 may include a single haptic device configured to produce multiple vibration frequencies or multiple haptic devices, where each haptic device is configured to produce a single frequency, or any combination thereof.

[0075] The SFSS logic 223 is configured to control the vibration of the haptic devices 550 so as to provide haptic sensory feedback based on the location of the medical device 150 within the Cartesian coordinate system 505 so that the user can adjust the location of the medical device 150 with respect to the target 56 or the access pathway based on the haptic sensory feedback provided by the haptic devices 550. In the illustrated embodiment, the haptic devices 550 are configured to produce five distinctly different vibration frequencies that correspond to the right, left, upward, downward, and outward directions 511, 512, 521, 522, 531. For example, the SFSS logic 223 may activate a first vibration frequency when the medical device 150 is located away from the access pathway 57 in the right direction 511. Similarly, the SFSS logic 223 may activate a second, third and fourth vibration frequencies when the medical device 150 is located away from the access pathway 57 in the left direction 511, the upward direction 521 or the downward direction 522, respectively. In this way, the user may know based on the vibration frequency of the haptic devices 550 which direction the user may adjust the location of the medical device 150 toward the access pathway 57. In some embodiments, the SFSS logic 223 may deactivate the first-fourth frequencies of the hapticdevices 550 when the medical device 150 is disposed within (i.e., aligned with) the access pathway 57. As such, the user may feel confident that insertion of the medical device 150 along the longitudinal axis of the medical device 150 will result in positioning the distal tip 151 at the target 56. Similarly, during insertion of the medical device 150, the re-activation of the haptic devices 500 at any of the first, second, third, or fourth vibration frequencies may indicate that the medical device 150 out of alignment with the access pathway 57 in the corresponding direction.

[0076] In some embodiments, the SFSS logic 223 may activate the haptic devices 550 at a fifth distinct vibration frequency when the medical device 150 is aligned with the access pathway 57 indicating that the distal tip 151 is spaced away from the target 56 along the access pathway 57. In such embodiments, the SFSS logic 223 may maintain activation of fifth vibration frequency during insertion until the distal tip 151 is disposed within the target 56, at which point the SFSS logic 223 may deactivate the fifth vibration frequency indicating that the distal tip 151 is disposed within the target 56. In such embodiments, when all five haptic vibrations are not activated, the user may know that the distal tip 151 is disposed within the target 56.

[0077] In use, the user may place the medical device 150 in proximity to the DGS module 110 and note the activation of vibration frequencies of the haptic devices 550. Based on the activation of the first, second, third or fourth vibration frequencies, the user may adjust the position of the medical device 150 until none of the first, second, third or fourth vibration frequencies are activated indicating that the medical device 150 is aligned with the access pathway 57. The user may then insert the medical device 150 into the patient while ensuring that the first, second, third or fourth vibration frequencies remain deactivated. The user may continue to insert the medical device 150 into the patient until the fifth vibration is deactivated indicating that the distal tip 151 is disposed within the target 56, i.e., that the medical device 150 is successfully placed within the target blood vessel 55.

[0078] As discussed above, the SFSS 140 may include a number of variable characteristics, where each variable characteristic has a magnitude that can vary between a first magnitude and a second magnitude, where the second magnitude is different from the first magnitude. In the illustrated embodiment, SFSS logic 223 may activate the first, second, third, fourth, and fifth vibration frequencies at varying magnitudes (i.e., vibration intensities). For example, alternatively or in addition to the SFSS logic 223 activating and deactivating the firstvibration frequency, the SFSS logic 223 may variably adjust a magnitude of the first vibration frequency. For example, the SFSS logic 223 may activate the first vibration frequency at a first magnitude when the medical device 150 is relatively near the access pathway 57 in the right direction 511 and activate the first vibration frequency at a second magnitude (e.g., a greater magnitude than the first magnitude) when the medical device 150 is relatively far from the access pathway 57 in the right direction 511. As such, the first vibration frequency may not only indicate that the medical device 150 misaligned from the access pathway 57 in the right direction 511, but also indicate the degree a misalignment. As such, the user may know if a relatively small or large positional adjustment is necessary to place the medical device 150 in alignment with the access pathway 57 in the right direction 511. The second, third, and fourth vibration frequencies may also variably indicate misalignment is a similar fashion.

[0079] Similarly, the SFSS logic 223 may adjust the magnitude of the fifth vibration frequency to indicate a relative distance of the distal tip 151 from the target 56 as the medical device 150 is advanced along the access pathway 57. Accordingly, the user may know if a relatively small or large positional insertion displacement is necessary to place the distal tip 151 at the target 56 based on the magnitude of the fifth vibration frequency.

[0080] Although not shown, in some embodiments, the haptic devices 550 may include at least two haptic devices located at different positions within the housing 111, such as a first haptic device 550 located within a top portion of the housing 111 and a second haptic device 550 located within a bottom end of the housing 111. In such embodiments, the SFSS logic 223 may activate, deactivate or adjust a variable characteristic of the first haptic device 550 in accordance with one of the lateral position or transverse position of the medical device 150 with respect to the access pathway 57. The SFSS logic 223 may further activate, deactivate or adjust a variable characteristic of the second haptic device 550 in accordance with the other one of the lateral position or transverse position of the medical device 150 with respect to the access pathway 57.

[0081] Although also not shown, in some embodiments, the haptic devices 550 may include at least two haptic devices oriented in different orientations within the housing 111, such as a third haptic device 550 oriented laterally with respect to the housing 111 to define a right to left vibration orientation of the housing 111 and a fourth haptic device 550 oriented perpendicular to the third haptic device 550 to define a front to back vibration orientation of the housing 111. In such embodiments, the SFSS logic 223 may activate, deactivate or adjusta variable characteristic of the third haptic device 550 in accordance with the lateral position of the medical device 150 with respect to the access pathway 57. The SFSS logic 223 may further activate, deactivate or adjust a variable characteristic of the forth haptic device 550 in accordance with the transverse position of the medical device 150 with respect to the access pathway 57.

[0082] FIG. 5C illustrates another exemplary embodiment of the SFSS 140, where the feedback mechanism devices 243 include a number (1, 2, 3 or more) of audio devices 560 disposed within the housing 111 or coupled with the housing 111. The audio devices 560 are configured to provide sensory feedback in the form of audible sounds or signals. FIG. 5C illustrates the front side 502 of the DGS module 110 and the target 56 with the access pathway 57 leading toward the target 56. FIG. 5C further illustrates the Cartesian coordinate system 505 of FIGS. 5A, 5B. Similar to the illuminating devices 540 and the haptic devices 550, the audio devices 560 are generally configured to provide sensory feedback to the user regarding the location of the medical device 150 within the Cartesian coordinate system 505 specifically in the right, left, upward, downward, or outward directions with respect to the access pathway 57 and the target 56. The audio devices 560 may include a single audio device configured to produce multiple distinct sounds or multiple audio devices, where each audio device is configured to produce a single sound, or any combination thereof. The distinct nature of the sounds may include pitch, beeping rate, pitch combinations, or any other differentiating audio characteristic that is distinctly detectable by the user.

[0083] The SFSS logic 223 is configured to control the sound of the audio devices 560 so as to provide audio sensory feedback based on the location of the medical device 150 within the Cartesian coordinate system 505 so that the user can adjust the location of the medical device 150 with respect to the target 56 or the access pathway 57 based on the audio sensory feedback provided by the audio devices 560. In the illustrated embodiment, the audio devices 560 are configured to produce five distinctly different sounds that correspond to the right, left, upward, downward, and outward directions 511, 512, 521, 522, 531. For example, the SFSS logic 223 may activate a first sound when the medical device 150 is located away from the access pathway 57 in the right direction 511. Similarly, the SFSS logic 223 may activate a second, third and / or fourth sound when the medical device 150 is located away from the access pathway 57 in the left direction 511, the upward direction 521 or the downward direction 522, respectively. In this way, the user may know based on the sound of the audio devices 560 whichdirection the user may adjust the location of the medical device 150 toward the access pathway 57. In some embodiments, the SFSS logic 223 may deactivate the first, second, third, and fourth sounds of the audio devices 560 when the medical device 150 is disposed within (i.e., aligned with) the access pathway 57. As such, when the first, second, third, and fourth sounds of the audio devices 560 are deactivated, the user may feel confident that insertion of the medical device 150 along the longitudinal axis of the medical device 150 will result in positioning the distal tip 151 at the target 56. Similarly, during insertion of the medical device 150, the reactivation of any of the first, second, third, or fourth sounds may indicate that the medical device 150 is out of alignment with the access pathway 57 in the corresponding direction.

[0084] In some embodiments, the SFSS logic 223 may activate a fifth distinct sound when the medical device 150 is aligned with the access pathway 57 indicating that the distal tip 151 is spaced away from the target 56 along the access pathway 57. In such embodiments, the SFSS logic 223 may maintain activation of the fifth sound during insertion until the distal tip 151 is disposed within the target 56, at which point the SFSS logic 223 may deactivate the fifth sound indicating that the distal tip 151 is disposed within the target 56. In such embodiments, when all five sounds are not activated, the user may know that the distal tip 151 is disposed within the target 56.

[0085] In use, the user may place the medical device 150 in proximity to the DGS module 110 and note the activation of the sounds of the audio devices 560. Based on the activation of the first, second, third or fourth sounds, the user may adjust the position of the medical device 150 until none of the first, second, third or fourth sounds are activated indicating that the medical device 150 is aligned with the access pathway 57. The user may then insert the medical device 150 into the patient while ensuring that the first, second, third or fourth sounds remain deactivated. The user may continue to insert the medical device 150 into the patient until the fifth sound is deactivated indicating that the distal tip 151 is disposed within the target 56, i.e., that the medical device 150 is successfully placed within the target blood vessel 55.

[0086] As discussed above, the SFSS 140 may include a number of variable characteristics, where each variable characteristic has a magnitude that can vary between a first magnitude and a second magnitude, where the second magnitude is different from the first magnitude. In the illustrated embodiment, SFSS logic 223 may activate the first, second, third, fourth, and fifth sounds at varying sound levels (i.e., sound volumes or dB). For example,alternatively or in addition to the SFSS logic 223 activating and deactivating the first sound, the SFSS logic 223 may variably adjust a sound level of the first sound. For example, the SFSS logic 223 may activate the first sound at a first sound level when the medical device 150 is relatively near the access pathway 57 in the right direction 511 and activate the first sound at a second sound level (e.g., a greater sound level than the first sound level) when the medical device 150 is relatively far from the access pathway 57 in the right direction 511. As such, the first sound may not only indicate that the medical device 150 misaligned from the access pathway 57 in the right direction 511, but also indicate the degree a misalignment. As such, the user may know if a relatively small or large positional adjustment is necessary to place the medical device 150 in alignment with the access pathway 57 in the right direction 511. Sound levels of the second, third, and fourth sounds may also variably indicate misalignment in a similar fashion.

[0087] Similarly, the SFSS logic 223 may adjust the sound level of the fifth sound to indicate a relative distance of the distal tip 151 from the target 56 as the medical device 150 is advanced along the access pathway 57. Accordingly, the user may know if a relatively small or large positional insertion displacement is necessary to place the distal tip 151 at the target 56 based on the sound level of the fifth sound. It is noted that sound level in only one variable characteristic of sound that could be employed. Other variable characteristics of sound could include pitch variation, beeping frequency, sound bites, words, or audio messages, for example.

[0088] Each of the SFSS 140 embodiments described in connection with FIGS. 5A-5C may be employed individually or employed in combination by the DGS 100. For example, any feature set of the visual sensory feedback of FIG. 5 A, the haptic sensory feedback of FIG. 5B or the audio sensory feedback of FIG. 5C may be combined with any feature set of one or both of the other two.

[0089] FIG. 6 is a block diagram of a method 600 of providing guidance for insertion of a medical device into a body of a patient that, according to some embodiments, may include all or any subset of the following steps, actions, operations or processes. The method 600 may be performed in accordance with logic of the device guidance system that includes an device guidance module. The method 600 includes defining an access pathway for the medical device based on target data (e.g., ultrasound data) of a target area of a patient (block 610). In accordance with some embodiments, defining the access pathway includes: (i) projecting, via the device guidance module, first signals (e.g., ultrasound signals) into the target area andreceiving second signals (e.g., reflected ultrasound signals) from the target area, (ii) converting the second signals into target data; (iii) identifying the target within the target area based on the target data; and (iv) determining a location of the target with respect to the device guidance module.

[0090] The access pathway extends toward a target within a target area of the patient. The method 600 further includes determining an alignment of the medical device with respect to the access pathway (block 620). In some embodiments, determining the alignment of the medical device with respect to the access pathway, includes detecting, via sensors of the device guidance module, a magnetic field defined by magnetic elements of the medical device; and determining a 3-D location of the medical device with respect to the access pathway based on the magnetic field. In some embodiments of the method 600, determining the 3-D location of the medical device includes determining a longitudinal location of a distal tip of the medical device along the access pathway with respect to the target, and the sensory feedback further indicates when the distal tip is disposed at the target.

[0091] In some embodiments of the method 600, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of misalignment between the medical device and the access pathway. In such embodiments, the sensory feedback includes a number of variable characteristics, where each variable characteristic has a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude. In some embodiments of the method 600, providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of misalignment. In some embodiments of the method, determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, and providing the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

[0092] The method 600 further includes providing sensory feedback to the user that includes guidance for insertion of the medical device (block 630). The sensory feedback specifically omits depicting a image of the target area on a display. In some embodiments of the method, the sensory feedback indicates when the medical device is aligned with the access pathway.

[0093] In some embodiments the method 600 further includes determining a variable degree of misalignment between the medical device and the access pathway (block 640). In some embodiments, the sensory feedback includes a number of variable characteristics, where each variable characteristic has a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude. In some embodiments, the method 600 further includes adjusting the magnitude of at least one variable characteristic of the sensory feedback based on the variable degree of misalignment (block 650). In some embodiments of the method 600, determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, and providing the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

[0094] In some embodiments of the method 600, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of lateral misalignment between the medical device and the access pathway, where the at least one variable characteristic includes a first variable characteristic, and where providing the sensory feedback includes adjusting the magnitude of the first variable characteristic based on the variable degree of lateral misalignment.

[0095] In some embodiments of the method 600, determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of transverse misalignment between the medical device and the access pathway, where the at least one variable characteristic includes a second variable characteristic, and where providing the sensory feedback includes adjusting the magnitude of the second variable characteristic based on the variable degree of transverse misalignment.

[0096] In some embodiments of the method 600, the number of feedback mechanisms include a number of light sources or illuminating devices, where the sensory feedback includes visual sensory feedback emanating from the light sources, and where the variable characteristic includes one or more of a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient.

[0097] In some embodiments of the method 600, the number of feedback mechanisms include a number of haptic transducers, where the sensory feedback includes haptic sensoryfeedback emanating from the haptic transducers via the housing of the device guidance module, and where the variable characteristic includes one or more of a vibration magnitude, or a vibration frequency.

[0098] In some embodiments of the method 600, the number of feedback mechanisms include a number of audio transducers, where the sensory feedback includes audio sensory feedback emanating from the audio transducers, and where the variable characteristic includes one or more of a pitch, a beeping cycle rate, or a sound level.

[0099] Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, 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 to be embraced within their scope.

Claims

CLAIMSWhat is claimed is:

1. A system for guiding insertion of a medical device into a body of a patient, comprising: a medical device configured for insertion into a target area of a patient, the medical device defining a distal tip and including a number magnetic elements configured to define a magnetic field; and a device guidance module configured to obtain target data of the target area, the device guidance module, comprising: a module head including target devices configured to project first signals into the target area and receive second signals from the target area; a number of sensors configured to detect the magnet field; a number of feedback mechanisms coupled with a housing of the device guidance module, the feedback mechanisms configured to provide sensory feedback to a user; and a console coupled with the target devices, the sensors, and the feedback mechanisms, the console including a processor and a memory having logic stored thereon that, when executed by the processor, performs operations that include: defining an access pathway for the medical device, the access pathway extending toward the target within the target area, wherein defining an access pathway includes: projecting the first signals into the target area and receiving the second signals from the target area; converting the second signals into the target data; identifying the target within the target area based on the target data; and determining a location of the target with respect to the device guidance module; determining an alignment of the medical device with respect to the access pathway, including:detecting the magnetic field defined by the magnetic elements; and determining a 3-D location of the medical device with respect to the access pathway based on the magnetic field; and providing sensory feedback that indicates when the medical device is aligned with the access pathway, the sensory feedback omitting a depiction of an image of the target area.

2. The system according to claim 1, wherein: determining a 3-D location of the medical device includes determining when the medical device is disposed within a detectable region of the magnetic field, and the sensory feedback further indicates when the medical device is disposed within the detectable region.

3. The system according to either claim 1 or 2, wherein: determining a 3-D location of the medical device includes determining a longitudinal location of the distal tip along the access pathway, and the sensory feedback further indicates when the distal tip is disposed at the target.

4. The system according to any of the preceding claims, wherein determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of misalignment between the medical device and the access pathway.

5. The system according to claim 4, wherein: the sensory feedback includes a number of variable characteristics, each variable characteristic having a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude, and providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of misalignment.

6. The system according to either claim 4 or 5, wherein: determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, andproviding the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

7. The system according to any of claims 4-6, wherein: determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of lateral misalignment between the medical device and the access pathway, the at least one variable characteristic includes a first variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the first variable characteristic based on the variable degree of lateral misalignment.

8. The system according to any of claims 4-7, wherein: determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of transverse misalignment between the medical device and the access pathway, the at least one variable characteristic includes a second variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the second variable characteristic based on the variable degree of transverse misalignment.

9. The system according to any of claims 4-8, wherein: the number of feedback mechanisms include a number of light sources, the sensory feedback includes visual sensory feedback emanating from the light sources, and the variable characteristics include one or more of a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient.

10. The system according to any of claims 4-8, wherein: the number of feedback mechanisms include a number of haptic transducers, the sensory feedback includes haptic sensory feedback emanating from the haptic transducers, and the variable characteristics include one or more of a vibration magnitude, a vibration frequency, a location of one or more of the haptic transducers within the housing, or a direction of vibration with respect to the housing.

11. The system according to any of claims 4-8, wherein: the number of feedback mechanisms include a number of audio transducers, the sensory feedback includes audio sensory feedback emanating from the audio transducers, and the variable characteristics include one or more of a pitch, a beeping cycle rate, or a sound level.

12. The system according to any of the preceding claims, wherein identifying the target within the target area includes identifying a blood vessel as the target.

13. The system according to claim 12, wherein identifying the target within the target area includes identifying the blood vessel as a vein.

14. The system according to any of the preceding claims, wherein the medical device includes a needle configured to access a blood vessel.

15. The system according to any of the preceding claims, wherein the magnetic elements include: at least one magnetic element disposed adjacent the distal tip, and at least one other magnetic element disposed proximal the at least one magnetic element.

16. The system according to any of the preceding claims, wherein: the device guidance module includes an ultrasound probe, the target devices include ultrasonic transducers, the first signals include ultrasonic signals generated by the ultrasonic transducers, and the second signals include reflected ultrasound signals.

17. A method of providing guidance for insertion of a medical device into a body of a patient, comprising: defining an access pathway for the medical device, the access pathway extending toward a target within a target area of the patient, wherein defining the access pathway includes: projecting, via an device guidance module, first signals into the target area and receiving second signals from the target area; converting the second signals into target data;identifying the target within the target area based on the target data; and determining a location of the target with respect to the device guidance module; determining an alignment of the medical device with respect to the access pathway, including: detecting, via sensors of the device guidance module, a magnetic field defined by magnetic elements of the medical device; determining a 3-D location of the medical device with respect to the access pathway based on the magnetic field; and providing, via feedback mechanisms of the device guidance module, sensory feedback including the guidance for insertion of a medical device, the sensory feedback omitting a depiction of an image of the target area.

18. The method according to claim 17, wherein the sensory feedback indicates when the medical device is aligned with the access pathway.

19. The method according to either claim 17 or 18, wherein: determining the 3-D location of the medical device includes determining a longitudinal location of a distal tip of the medical device along the access pathway with respect to the target, and the sensory feedback further indicates when the distal tip is disposed at the target.

20. The method according to any of claims 17-19, wherein: determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of misalignment between the medical device and the access pathway, the sensory feedback includes a number of variable characteristics, each variable characteristic having a magnitude that varies between a first magnitude and a second magnitude, the second magnitude different from the first magnitude, and providing the sensory feedback includes adjusting the magnitude of at least one variable characteristic based on the variable degree of misalignment.

21. The method according to claim 20, wherein: determining the 3-D location of the medical device includes determining a variable longitudinal location of the distal tip of the medical device along the access pathway with respect to the target, andproviding the sensory feedback includes adjusting the magnitude of at least one other variable characteristic based on the variable longitudinal location of the distal tip with respect to the target.

22. The method according to either claim 20 or 21, wherein: determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of lateral misalignment between the medical device and the access pathway, the at least one variable characteristic includes a first variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the first variable characteristic based on the variable degree of lateral misalignment.

23. The method according to any of claims 20-22, wherein: determining the 3-D location of the medical device with respect to the access pathway includes determining a variable degree of transverse misalignment between the medical device and the access pathway, the at least one variable characteristic includes a second variable characteristic, and providing the sensory feedback includes adjusting the magnitude of the second variable characteristic based on the variable degree of transverse misalignment.

24. The method according to any of claims 20-23, wherein: the number of feedback mechanisms include a number of light sources, the sensory feedback includes visual sensory feedback emanating from the light sources, and the variable characteristics include one or more of a brightness, a color, a flashing cycle rate, a pattern, a location on the housing, or a projected location on the patient.

25. The method according to any of claims 20-24, wherein: the number of feedback mechanisms include a number of haptic transducers, the sensory feedback includes haptic sensory feedback emanating from the haptic transducers, and the variable characteristics include one or more of a vibration magnitude, a vibration frequency, a location of one or more of the haptic transducers within the housing, or a direction of vibration with respect to the housing.

26. The method according to any of claims 20-25, wherein: the number of feedback mechanisms include a number of audio transducers, the sensory feedback includes audio sensory feedback emanating from the audio transducers, and the variable characteristics include one or more of a pitch, a beeping cycle rate, or a sound level.

27. The method according to any of claims 17-26, wherein: the device guidance module includes an ultrasound probe, the first signals include ultrasonic signals generated by ultrasonic transducers of the ultrasound probe, and the second signals include reflected ultrasound signals.

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