WO2026010754A1

WO2026010754A1 - Systems and methods for providing procedural instructions

Info

Publication number: WO2026010754A1
Application number: PCT/US2025/034837
Authority: WO
Inventors: Matthew J. Prince
Original assignee: Bard Access Systems Inc
Current assignee: Bard Access Systems Inc
Priority date: 2024-07-03
Filing date: 2025-06-23
Publication date: 2026-01-08
Anticipated expiration: 2027-01-03

Abstract

A medical system module configured to provide instructions to a user includes an input module configured to receive input pertaining to medical procedures to be performed on a patient by a user utilizing the medical system and an output module configured to provide to the user instructions for performing the medical procedures. Logic operations of the system include defining a set of the instructional steps to be followed during a performance of a selected medical procedure. A medical system can include magnetic tracking of a medical device and determining a shape of the medical device optical fiber shape sensing. Logic operations can include Artificial intelligence techniques. Providing user instructions can include pictorial illustrations as well as textual instructions. Pictorial illustrations can include historical image or other visual representations previously recorded and stored in memory. Logic determines completion of instructional steps by comparing a live visual representation with historical visual representations.

Description

SYSTEMS AND METHODS FOR PROVIDING PROCEDURAL INSTRUCTIONS

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/667,311, filed luly 3, 2024, which is incorporated by reference in its entirety into this application.

BACKGROUND

[0002] Performing medical procedures on patients are not devoid of risk. Human factors play a large roll in medical errors. Variations in medical systems and devices require practitioners to be trained in a wide variety of procedures for use of the systems and methods. Providing adequate instructions for performing medical procedure without error is paramount in preventing patient harm due to human error. Difficulty in accessing instructions can increase human error and patient harm. As such, there is a need to provide instruction at the time and point of care. Systems and methods disclosed herein address the foregoing.

SUMMARY

[0003] Briefly summarized, embodiments disclosed herein are directed to systems and methods for providing instructions to a user for the performance of a medical procedure. Disclosed herein is a system that, according to some embodiments, includes a system module, where the system module includes (i) an input module configured to receive input pertaining to medical procedures to be performed on a patient by a user utilizing the medical system; (ii) an output module configured to provide to the user instructions for performing the medical procedures; and (iii) a console coupled with the input module and the output module, the console including a processor and a memory having a logic stored thereon that, when executed by the processor, performs operations of the medical system. The operations include (i) receiving the input via the input module; (ii) selecting a medical procedure based on the input; (iii) defining a set of the instructional steps to be followed during a performance of the medical procedure; and (iv) providing the set of instructional steps to the user via the output module.

[0004] In some embodiments, the output module includes a display, and providing the set of instructional steps to the user includes visually providing the set of instructional steps on the display. In some embodiments, visually providing the set of instructional steps on the display includes portraying a number of images or an animation on the display. In some embodiments, the output module includes a speaker, and providing the set of the instructional steps to the user includes audibly providing at least a subset of the instructional steps to the user.

[0005] In some embodiments, the memory includes a database of historical instructional steps stored thereon, and defining the set of the instructional steps includes incorporating a number of the instructional steps from the database of historical instructional steps into the set of the instructional steps.

[0006] In some embodiments, the input module includes a user interface, and receiving the input includes receiving user entered input via the user interface. In some embodiments, the user interface includes a microphone, and the user entered input includes a voice command. In some embodiments, the input includes the medical procedure. In some embodiments, the selected medical procedure is chosen from a database of medical procedures stored in memory.

[0007] In some embodiments, the system further includes a medical device to be utilized during the performance of the medical procedure, and the medical device is configured for placement within a patient.

[0008] In some embodiments, the input module includes a scanning device, where (i) the scanning device is configured to obtain medical device information coupled with the medical device, (ii) the input includes the medical device information, and (iii) the scanning device is one of a RFID reader, a barcode reader, or a camera.

[0009] In some embodiments, the operations further include modifying the set of the instructional steps based on the user entered input via the user interface to define a custom set of instructional steps linked to the user, the modification including at least one of (i) adding one or more instructional steps to the set of the instructional steps; (ii) removing one or more instructional steps from the set of the instructional steps; (iii) modifying individually one or more instructions steps of the set of the instructional steps; or (iv) modifying an order of the set of the instructional steps.

[0010] In some embodiments, the system further includes an imaging system including an imaging probe, the imaging system configured to obtain a live image of subcutaneous anatomical elements of the patient and simultaneously portray the live image on the display along with providing the set of instructional steps. [0011] In some embodiments, the memory includes a database of historical images of the subcutaneous anatomical elements stored thereon, and the operations further include linking one or more of the historical instructional steps with one or more of the historical images.

[0012] In some embodiments, the system further includes a medical device tracking system including a magnetic field sensor coupled with the patient, the medical device tracking system configured to track the live location of the medical device during placement within the patient by magnetically tracking the location of a number of magnetic portions of the medical device with respect to the magnetic field sensor, and simultaneously portraying the live location of the medical device within the patient on the display along with providing the set of instructional steps.

[0013] In some embodiments, the system includes the medical device tracking system, and the operations include (i) providing a fourth instruction step including portraying on the display a fourth pictorial illustration linked to the fourth instruction step, where the fourth pictorial illustration depicts the medical device at a second location; and (ii) overlaying a live visual representation of the medical device directly atop the fourth pictorial illustration, where the live visual representation depicts the medical device at a first location within the patient consistent with completion of a third instructional step, and the fourth instruction step instructs the user to advance the medical device from the first location depicted in the live visual representation to the second location depicted in the fourth pictorial illustration.

[0014] In some embodiments, the medical system further includes a shape sensing system configured to determine a live shape of the medical device by determining a shape of an optical fiber coupled with the medical device and simultaneously portray the live shape of the medical device on the display along with providing the set of instructional steps.

[0015] In some embodiments, the memory includes a database of historical shapes of the medical device stored thereon, where the historical shapes include at least a first historical shape and a second historical shape different from the first historical shape, and the operations further include (i) comparing the live shape with the first and second historical shapes; (ii) determining from the comparison that the live shape matches the first historical shape and providing one subset of the set of instructional steps; and determining from the comparison that the live shape matches the second historical shape and providing a subset of the set of instructional steps different from the one subset.

[0016] Also disclosed herein is a method of providing instructions for performing a medical procedure that, according to some embodiments, includes (i) selecting a medical procedure to be performed utilizing a medical system; (ii) defining a set of instructional steps to be followed during the performance of the selected medical procedure; and (iii) providing the set of instructional steps to a user of the medical system via an output module of the medical system.

[0017] In some embodiments of the method, providing the set of instructional steps includes portraying on a display of the system each of the instructional steps in a textual form and portraying on the display one or more pictorial illustrations linked via logic of the medical system to one or more of the instructional steps, each pictorial illustration including one or more of a drawing, a picture, a diagram, a video, or an animation.

[0018] In some embodiments of the method, providing the set of the instructional steps to the user includes audibly providing one or more of the instructional steps to the user via a speaker of the output module.

[0019] In some embodiments of the method, selecting the medical procedure includes selecting the medical procedure from the database of medical procedures stored in a memory of the medical system.

[0020] In some embodiments of the method, defining the set of the instructional steps includes acquiring one or more historical instructional steps from a database of historical instructional steps stored in the memory and incorporating the one or more historical instructional steps into the set of instructional steps. In some embodiments of the method the one or more pictorial illustrations are acquired from a database of historical pictorial illustrations stored in the memory.

[0021] In some embodiments of the method, selecting the medical procedure is based on input received by the medical system, where the input includes one or more of: user-entered input received via a graphical user interface of the system; a voice command from the user received via a microphone of the medical system; a communication received from a network coupled with the system; or medical device information acquired from a medical device to be utilized in performing the medical procedure, where the medical device information is acquired by scanning the medical device via a scanning device of the medical system, and where the scanning device includes an RFID reader, a barcode reader, or a camera.

[0022] In some embodiments, the method further includes modifying the set of the instructional steps based on user-entered input via the user graphical user interface to define a custom set of instructional steps linked to the user, where the modification includes at least one of adding one or more instructional steps to the set of the instructional steps; removing one or more instructional steps from the set of the instructional steps; modifying one or more instructions steps of the set of the instructional steps; or modifying an order of the set of the instructional steps.

[0023] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Embodiments of the disclosure are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:

[0025] FIG. 1 is an illustrative embodiment of a medical system utilized in placement of medical devices within a patient, in accordance with some embodiments;

[0026] FIG. 2 is a block diagram of console of the system of FIG. 1, in accordance with some embodiments;

[0027] FIGS. 3A-3D illustrates screenshots that may be portrayed on a display of the system of FIG. 1, , in accordance with some embodiments; and

[0028] FIG. 4 is a block diagram of a method of providing instructions to a user for the performance of medical procedures to be performed utilizing the system of FIG. 1.

DETAILED DESCRIPTION

[0029] 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 the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0030] 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.

[0031] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a probe disclosed herein includes a portion of the probe intended to be near a clinician when the probe is used on a patient. Likewise, a “proximal length” of, for example, the probe includes a length of the probe intended to be near the clinician when the probe is used on the patient. A “proximal end” of, for example, the probe includes an end of the probe intended to be near the clinician when the probe is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the probe can include the proximal end of the probe; however, the proximal portion, the proximal end portion, or the proximal length of the probe need not include the proximal end of the probe. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the probe is not a terminal portion or terminal length of the probe.

[0032] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a probe disclosed herein includes a portion of the probe intended to be near or in a patient when the probe is used on the patient. Likewise, a “distal length” of, for example, the probe includes a length of the probe intended to be near or in the patient when the probe is used on the patient. A “distal end” of, for example, the probe includes an end of the probe intended to be near or in the patient when the probe is used on the patient. The distal portion, the distal end portion, or the distal length of the probe can include the distal end of the probe; however, the distal portion, the distal end portion, or the distal length of the probe need not include the distal end of the probe. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the probe is not a terminal portion or terminal length of the probe.

[0033] The term “logic” may be representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and/or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.), a semiconductor memory, or combinatorial elements.

[0034] Additionally, or in the alternative, the term logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library/dynamic link library (dll), or even one or more instructions. This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of a non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random-access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the logic may be stored in persistent storage.

[0035] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and/or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0036] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0037] FIG. 1 illustrates an embodiment of a medical system that is generally configured to provide instructions on a display of the system to a clinical or other user for the performance of a medical procedure utilizing the medical system. One example of a medical procedure includes placement of the medical device within a patient. While the figures and description that follow show and describe a medical system (system) 100 that can be utilized, for example, during placement of the medical device within a patient, the medical system 100 is not limited to medical procedure that include placement of a medical device within a patient, but is broad enough to include any medical procedure where providing procedural instructions can be advantageous. Similarly, embodiments of the system 100 can include all or any subset of the subsystems, components, and functionalities shown and described herein. The system 100 can employed to provide instructions pertaining to placement of the medical device within the patient, where placement the medical device may include multiple procedure steps, such as inserting the medical device through a skin of the patient and into a vasculature of the patient, and/or advancing the medical device along the vasculature so as to position of the distal tip of the medical device at a selected location within the patient, for example.

[0038] The system 100 generally includes a system module 110 having a console 115 which includes logic that governs the operation of the system 100 as further described below. The system module 110 includes or is coupled with a display 111 configured to provide visual instructions to the clinician. The instructions may include textual information 112 and/or image information 113. The display 111 may include a liquid crystal diode (LCD) display integrated into the console 115 and employed as a user interface (e.g., a graphical user interface) to display information to the clinician, especially during the medical procedure. In another embodiment, the display 111 may be separate from the console 115. Although not shown, a user interface is configured to provide user control of the console 115. The system module 110 may also be configured to provide audio information 114 via a speaker.

[0039] The system module 110 may be communicatively coupled (wired or wireless) with a network 103 so that the system 100 may provide information to the network 103 and receive information from the network 103. In some embodiments, the system 100 may be one of a plurality of systems 100 communicatively coupled with the network 103 such that network 103 can receive information from and provide information to the plurality of systems 100. Accordingly, information can be shared between the plurality of systems 100. In some embodiments, the network 103 may include or be coupled with an electronic medical record (EMR) system.

[0040] For descriptive purposes, the system 100 may be divided into two subsystems related to different medical procedures. Subsystem 101 may be utilized during access of the vasculature, and subsystem 102 may be utilized during advancement of the medical device along the vasculature.

[0041] With further reference to FIG. 1, the subsystem 101 is generally configured for utilization during the access of the vasculature of the patient 50, including mapping/tracking a trajectory or path of a medical device during insertion of the medical device (e.g., a needle) into the vasculature. As shown, the subsystem 101 generally includes an imaging probe, e.g., an ultrasound probe 160, coupled with the system module 110. The ultrasound imaging probe 160 may be configured to obtain a subcutaneous image of a target area 140 of the patient 50, detect blood vessels, (e.g., the blood vessels 141, 142) within the target area 140, and define a target blood vessel (e.g., the blood vessel 142) as taught by U.S. Publication No. 2021/0085282, titled “Automatic Vessel Detection Tools and Methods,” and filed September 14, 2020, which is incorporated herein by reference is its entirety. The ultrasound probe 160 may include controls 165, such as buttons, for example, where operations of the system 100 can be manipulated via the controls 165.

[0042] The ultrasound imaging probe 160 is operably coupled with the system module 110 via an electrical cable 161 so that ultrasound images can be transmitted to the system module 110 for portrayal on the display 111. An optical fiber 162 may also be physically coupled between the ultrasound imaging probe 160 and the system module 110. The optical fiber 162 is configured for shape sensing so that a position and orientation of the ultrasound imaging probe 160 in 3-D space may be determined. In some embodiments, the optical fiber 162 may be incorporated into the electrical cable 161.

[0043] The subsystem 101 includes a vascular access device (VAD) 170 configured to access the vasculature of the patient 50. The VAD 170 may include a needle having one or more magnetized portions 171 configured to define a magnetic field detectable by one or more magnetic field sensors 172 coupled with the ultrasound probe 160. The one or more magnetized portions 171 and one or more magnetic field sensors 172 are configured such that a position and orientation of the VAD 170 with respect to the ultrasound probe 160 can be determined and tracked. Further details regarding magnetically tracking the VAD 170 are taught by U.S. Publication No. 2023/0121370, filed October 13, 2022, which is incorporated herein by reference is its entirety. Magnetic tracking of the VAD 170 with respect to the ultrasound probe 160 and defining the target blood vessel 142 (described above) enables tracking of the VAD 170 with respect to the targeted blood vessel 142 and depicting a live visualization of the VAD 170 with respect to target blood vessel 142 on the display 111. As such, the live visualization of the VAD 170 with respect to target blood vessel 142 on the display 111 provides guidance to the user during access of the vasculature and may be used in providing instructions to the user.

[0044] The subsystem 101 may optionally include a VAD optical fiber 174 physically coupled between the VAD 170 and the ultrasound imaging probe 160 or the system module 110. The VAD optical fiber 174 is configured for shape sensing similar to the optical fiber 162 so that a position and an orientation of the VAD 170 in 3-D space can be determined. Accordingly, the position and an orientation of the VAD 170 can be tracked via shape sensing of the VAD optical fiber 174, which can be utilized in combination with or as an alternative to magnetic tracking of the VAD 170.

[0045] By way of summary, the subsystem 101 may track the location and orientation of the VAD 170 during access of the vasculature, and thereby, provide real time feedback to the user so that the user can successfully perform the access procedure of the VAD 170 ensuring that the distal tip of the VAD 170 is properly positioned within the target blood vessel 142.

[0046] The subsystem 102 is generally configured to enable placement of a medical device within the vasculature of the patient 50, which may be performed after accessing the vasculature as described above in relation the subsystem 101. In the illustrated embodiment, the medical device includes an elongate probe 130 which may include a catheter, a stylet, a guidewire or any elongate device suitable for placement within and advancement along the vasculature. The subsystem 102 is generally configured for tracking the location/position of the elongate probe 130 during placement of the elongate probe 130 within the vasculature, including advancement of the elongate probe 130 along the vasculature and placement of a distal tip 131 of the elongate probe 130 at a selected location within the vasculature, such as the lower l/3^rd of the superior vena cava, for example.

[0047] The subsystem 102 may include a sensor module 120 including a number (e.g., three or more) of magnetic field sensors 122 (which may be similar to the magnetic field sensors 172), where the sensor module 120 is coupled with the system module 110. The sensor module 120 may be placed on the patient 50 (e.g., the torso) during placement of the elongate probe 130. The elongate probe 130 includes a plurality of magnetized portions 121 disposed along a detectable portion of the elongate probe 130 including a distal tip 131 thereof. The sensor module 120 is configured to detect magnetic fields generated by the plurality of magnetized portions 121 such that the locations of each of the magnetized portions 127 within the patient body with respect to the sensor module 120 can be determined. The sensor module 120 may be placed patient in relation to selected anatomical landmarks such that a location with respect to the sensor module 120 can be associated with the one or more anatomical landmarks, such as the heart for example. In this way, the subsystem 102 can track the location of the elongate probe 130 along the vasculature of the patient 50. As such, a live visualization of the elongate probe 130 with respect to the selected anatomical target may be portrayed on the display 111, and thereby, provide guidance to the user during advancement of the elongate probe 130 along the vasculature. Further details regarding magnetically tracking the elongate member are taught by U.S. Patent No. 8,388,541 entitled "Integrated System for Intravascular Placement of a Catheter,” which is incorporated herein by reference is its entirety.

[0048] The subsystem 102 may optionally include an optical fiber 135 extending along the elongate probe 130, where the optical fiber 135 is optically coupled with the console 115. The optical fiber 135 is configured for shape sensing similar to the optical fiber 162 so that a 3-D shape of the elongate probe 130 can be determined and portrayed on the display 111, which can also provide guidance to the user during advancement of the elongate probe 130 along the vasculature. Further details regarding elongate probe having an optical fiber configured for shape sensing are taught by U.S. Patent application No. 17/945,934, filed Sept. 15, 2022,

-l i entitled "Magnetically Oriented Fiber Optic Three-Dimensional Shape,” which is incorporated herein by reference is its entirety. The optical fiber 135 is optically coupled with the system module via an optical interconnect 136.

[0049] The subsystem 102 may optionally an electro-cardiogram (ECG) electrode 137 disposed at the distal tip 131 of the elongate probe 130, where the ECG electrode 137 is electrically coupled (e.g., via wire, not shown, extending along the elongate probe 130) with the console 115 so that an ECG signal may be received by the console 115. The subsystem 102 may be configured to track the location of the distal tip 131 within the superior vena cava based on the ECG signal obtained by the elongate probe 130. Further details regarding utilizing ECG waveforms to confirm catheter location are taught by U.S. Patent No. 11,918,339, filed July 24, 2020, entitled " System and Method of Utilizing ECG Signal for Static Catheter Tip Confirmation,” which is incorporated herein by reference is its entirety.

[0050] By way of summary, the subsystem 102 may track the location and/or shape of the elongate probe 130 during advancement of the elongate probe 130 along the vasculature of the patient 50 and thereby, provide real time feedback to the user so that the user can successfully perform the placement procedure of the elongate probe 130 ensuring that the distal tip 131 is properly positioned at the selected location along the vasculature.

[0051] Each of the optical fibers, i.e., the optical fiber 162, the VAD optical fiber 174, and optical fiber 135 may be configured to enable determination of their respective physical states (e.g., shape) based on characteristics of reflected light signals defined by Bragg gratings disposed along their respective lengths as taught by U.S. Publication No. 2022/0369934 filed May 18, 2022, which is incorporated herein by reference is its entirety.

[0052] FIG. 2 illustrates a block diagram of the console 115, according to some embodiments. The console 115 is generally configured to govern the operation of the system 100. The console 115 includes a processor 210 and memory 220 (e.g., a non-transitory computer-readable medium) having logic stored thereon. For description purposes, the logic may include logic modules, such as instruction logic 221, artificial intelligence (Al) logic 222, shape sensing logic 224, imaging logic 225, magnetic tracking logic 226, and ECG logic 227, which may be referred to collectively as “logic.” Each of the logic modules may exchange data with a data repository 223. [0053] The data repository 223 may include a database of historical instructional steps and in some embodiments defining the set of the instructional steps may include incorporating therein a number of the instructional steps from the database of historical instructional steps.

[0054] The data repository 223 may also include a database of historical images of target areas. In some embodiments, the logic may link one or more of the historical instructional steps with one or more of the historical images.

[0055] The data repository 223 may include a database of historical images that include veins and arteries. The logic may compare a live image of the blood vessel with the one or more vein images and/or one or more artery images. The logic may as a result of comparison determine that the blood vessel is a vein when the live image of the blood vessel matches the one or more vein images, or (ii) determine that the blood vessel is an artery when the live image of the blood vessel matches the one or more artery images.

[0056] The console 115 includes an electrical interface 202 including electrical connectors to define operative coupling between the console 115 and the ultrasound probe 160, the magnetic sensors 172 of the ultrasound probe 160, and the magnetic sensors 122 of the sensor module 120. The console 115 also includes an optical interface 203 to facilitate optical coupling between an optical module 230 of the console 115 and the optical fiber 162, the VAD optical fiber 174, and the optical fiber 135 (collectively “optical fibers”). The optical module 230 includes a light source 232 configured to provide light to the optical fibers and an optical receiver 234 configured to receive light signals from the optical fibers and converts the optical signals into electrical signals. Optical logic 236 governs the operation of the light source 232 and the optical receiver 234.

[0057] A power source 215 (e.g., a battery, a facility power source, or both) provide electrical power to the console 115, and a wireless module 205 can facilitate wireless communication with the network 103 or other external devices. The system 100 may also include a scanning device 206 coupled with the console 115 via the electrical interface 202. The scanning device 206 may include a camera, an RFID reader, a barcode reader or the like, configured to obtain medical device information from medical devices (e.g., the VAD 170 and/or the elongate probe 130) via a scanning process. The system 100 may also include an audio speaker 207 integrated into or coupled with the console 115 and/or the display 111. The audio speaker 207 is configured to provide audio output to the user. The audio output may include alarms, soundbites, and/or audio instructions.

[0058] The imaging logic 225 is configured to receive image data from the ultrasound probe 160 and process the image data such that a live image of the target area 140 may be portrayed on the display 111. The imaging logic 225 may determine the target blood vessel 142 from other anatomical elements that may be present the live image and provide a visual indication of the target blood vessel 142, such as an arrow pointing to the target blood vessel 142 or a border surrounding the target blood vessel 142, for example. The imaging logic 225 may also determine a location and a depth of the target blood vessel 142 with respect to the ultrasound probe 160. The imaging logic 225 may also freeze a live image of the target area 140 on the display 111 and record a frozen image in the data repository 223.

[0059] The magnetic tracking logic 226 is configured to process magnetic tracking data from magnetic field sensors 172 to define a position of the VAD 170 with respect to the ultrasound probe 160 (i.e., with respect to the location of the ultrasound probe 160). Having defined the location of the VAD 170 with respect to the ultrasound probe 160, the imaging logic 225 may utilize the tracking data from magnetic field sensors 172 to superimpose a visualization of the VAD 170 onto the live ultrasound image of the target area 140, such that the user may observe the location and orientation of the VAD 170 with respect to the target blood vessel 142.

[0060] The magnetic tracking logic 226 is configured to process magnetic tracking data from the magnetic field sensors 122 of the senser module 120 to define a position of the elongate probe 130 with respect to the senser module 120 placed on the patient 50. As the sensor module 120 is placed over the heart and as the elongate probe 130 includes magnetized portions 121 adjacent to and extending proximally away the distal tip 131, the magnetic tracking logic 226 may process magnetic tracking data to determine the location of the elongate probe 130 (including the distal tip 131) with respect to the heart. Having determined the location of the elongate probe 130 with respect to the heart, the imaging logic 225 may utilize the tracking data from the sensor module 120 to superimpose a real time visualization of the elongate probe 130 onto a visual representation of the torso of the patient 50 on the display 111, including a real time visualization of the distal tip 131 with respect to the heart. [0061] The shape sensing logic 224 is generally configured to receive optical data related to an optical fiber and process the optical data to determine a 3-D shape of the optical fiber. As opposite ends of the optical fiber may be physically attached to components, a positional relationship of the components may be determined based on the 3-D shape of the optical fiber. In the illustrated embodiment, the VAD optical fiber 174 is physical attached between the VAD 170 and ultrasound probe 160. A such, the shape sensing logic 224 may determine a real-time positional relationship (including orientation) of the VAD 170 with respect to the ultrasound probe 160. Further in the illustrated embodiment, the optical fiber 162 is physical attached between the ultrasound probe 160 and the system module 110. A such, the shape sensing logic 224 may determine a real-time positional relationship (including orientation) and/or movement of the ultrasound probe 160 with respect to the system module

110.

[0062] The shape sensing logic 224 may also be configured determine a 3-D shape of the optical fiber 135 and thereby determine the 3-D shape of the elongate probe 130. As such, the shape sensing logic 224 may be determine a real-time shape of the elongate probe 130 during placement of the elongate probe 130 within the vasculature. Having determined the realtime shape of the elongate probe 130, the imaging logic 225 may portray a real-time visualization of the shape of the elongate probe 130 on the display 111.

[0063] The ECG logic 224 is configured receive ECG data and a determine real-time ECG waveform configured for portrayal on the display 111. Having determined the real-time ECG waveform, the imaging logic 225 may portray the real-time ECG waveform on the display

111.

[0064] In some embodiments, the console 115 may include a user interface 211 such as a graphical user interface incorporated into the display 111 or the system module 110 generally. The user interface 211 is configured to receive input from the user and provide output to the user. The user interface 211 may be configured to receive touch input and/or audio input from the user. The user interface may include a microphone 212 configured to receive the audio input, such as voice commands from the user. The term “input module” as used herein can include input components that enable the system 100 receive input, such as the user interface 211 (e.g., graphical user interface), the scanning device 206, the microphone 212, and/or the network 103 in combination with logic that facilitates operation of the input components and receiving the input via the input components. Similarly, the term “output module,” as used herein, can include output components that enable system 100 to provide output to the user, such as the display 111 and/or the speaker 207, in combination with logic that facilitates operation of the output components and providing output to the user via the output components.

[0065] The performing of the medical procedures described above can include performing a plurality of procedural steps. Consequently, instructions for performing a selected medical procedure can include a set of instructional steps related to the procedural steps for the selected medical procedure. Medical procedures can vary due to varying medical devices and/or varying patients. For example, the procedure for placing a peripherally inserted central catheter (PICC) can vary based an insertion site, the PICC catheter model, and/or physiological characteristics of the patient, including size, weight, age, diseases, and the like. Accordingly, instructions for placing the PICC can include different sets of instructional steps. In some cases, one set of instructional steps and include a subset of a different set of instructional steps. Given the foregoing, it may be advantageous for a system to create a set of instructional steps for performing a selected medical procedure, on a given patient, utilizing a selected medical device at the time the selected medical procedure is performed (i.e., on the fly) rather than maintaining individual sets of instructional steps for the all the permutations of the medical procedure required for the varying conditions described above. Furthermore, sets of instructions steps may require modification over time as medical procedures are improved or adjusted over time.

[0066] System operations as performed by logic of the system 100 may overcome or at least provide improvement over the complexities of providing a set of instructional steps for the performing a medical procedure utilizing the system 100. Described below are example of operations performed by the instruction logic 221, which may be performed in combination with any subset of the logic modules described above. Accordingly, the term “logic” as used herein can include any of the logic modules described above or any combination of the logic modules.

[0067] The instruction logic 221 is generally configured to provide a set of instructional steps to the user of the system 100 so that the user can effectively and safely perform a selected medical procedure utilizing the system 100. The instruction logic 221 determines (or selects) medical procedure for which the set of instructional steps are to be provided in accordance with input received via the input module. In some embodiments, the data repository 223 may include a database of medical procedures, and the logic may select one the medical procedures of the database of medical procedures based on the input. In one implementation, the user may select the medical procedure from a list of the medical procedures stored in the database of medical procedures via the user interface 211. In another implementation, the medical procedure may be transmitted to the system 100 from the network 103, or the logic may select one of the medical procedures stored in the database of medical procedures based on information transmitted (e.g., a medical device to be used) to the system 100 from the network 103. In another implementation, the logic may select one of the medical procedures stored in the database of medical procedures based on information obtained by the scanning device, such a type or model of the medical device to be used, for example. In still another implementation, the user may select the medical procedure from a list of the medical procedures stored in the database via a voice command received by the microphone 212.

[0068] Having determined the medical procedure (i.e., once the medical procedure is selected), the instruction logic 221 may define or create the set of instructional steps. In some embodiments, the data repository 223 may include a database of historical instructional steps, and the logic may select a number of historical instructional steps from the database of historical instructional steps to define the set of instructional steps.

[0069] In some embodiments, instruction logic 221 may enable the user to modify the set of the instructional steps via the user interface 211 to define a custom set of instructional steps linked to the user. Modifications to the set of the instructional steps may include (i) adding one or more instructional steps to the set of the instructional steps; (ii) removing one or more instructional steps from the set of the instructional steps; (iii) modifying individually one or more instructions steps of the set of the instructional steps; and/or (iv) modifying an order of the set of the instructional steps.

[0070] FIGS. 3A-3D illustrate examples of screenshots that may be portrayed on the display 111 in accordance with providing the set of instructional steps for performing a selected medical procedure. As the set of instructional steps may include a plurality of instructional steps, a plurality of screenshots that may be portrayed on the display 111 together with the set of instructional steps. One or more screenshots may be associated with a single instructional step, and one or more instructional steps may be associated with a single screenshot.

[0071] FIG. 3A illustrates an example of a screenshot that may be portrayed on the display 111, according to some embodiments. The screen shot 301 provides instruction to the user for performing a one example of a medical procedure 310. In the illustrated example, the medical procedure 310 is a PICC placement procedure. The screenshot 301 includes an instructional step 312 (i.e., a textual instruction) of a set of instructional steps defined for the medical procedure 310. In some embodiments, the screenshot 301 may include a “back” button 314 configured to go back to a previous instructional step, and a “next” button 316 configured to move forward to a following instruction step.

[0072] In some embodiments, the screen shot 301 may also include one or more pictorial illustrations 318 related to the instructional step 312, such as a drawing, a picture, a diagram, a video or an animation, for example. In some embodiments, the pictorial illustration 318 may be chosen from a database of historical pictorial illustrations stored in the data repository 223. Accordingly, the pictorial illustration 318 may be logically linked (i.e., linked via logic) to the instructional step 312.

[0073] FIG. 3B illustrates an example of a screenshot similar to the screenshot 301 of FIG. 3 A further including a live visual representation 320 related to the instructional step 312, according to some embodiments. In the illustrated example, the live visual representation 320 includes a live ultrasound image 322 of the target area 140 including a target blood vessel image 324 (e.g., a vein image of the vein 142). The live visual representation 320 further includes a VAD image 326 (i.e., a visual representation of the VAD 170) superimposed atop the live ultrasound image 322 showing a live location and orientation of the VAD 170 with respect to the target blood vessel image 324 as may be determined magnetically or optically as described above. As such, the user can determine when the instructional step 312 has been completed.

[0074] In some embodiments, the logic may automatically determine when the instructional step 312 is completed. For example, the logic may determine when the VAD 170 is aligned with the target blood vessel (i.e., the vein 142). In some embodiments, the logic may transition the “next” button 316 from a disabled state (e.g., grayed out) to an enabled state so that the user can press the “next” button 316 and move forward to the following instructional step. In some embodiments, the logic, having determined that the instruction step 312 has been completed, may automatically move forward to the following instructional step. In a similar fashion, the logic, after having determined that the instruction step 312 has been completed and moved forward to the following instructional step, may determine that the instruction step 312 needs to be repeated and automatically move back from the following instructional step to the instruction step 312. For example, the user, having once aligned the VAD 170 with the target blood vessel, may move the VAD 170 out of alignment with the target blood vessel, thus requiring re-alignment.

[0075] FIG. 3C illustrates an example of a screenshot that may be portrayed on the display 111, according to some embodiments. The screen shot 303 provides instructions to the user for performing a medical procedure 310. The screen shot 303 may, in certain respects, resemble the screenshot 302. In the illustrated example of FIG. 3C, the medical procedure 310 is the PICC placement procedure at a later stage where the PICC is advanced along the vasculature of the patient 50. The screenshot 303 includes the instructional step 323 (i.e., a textual instruction) of a set of instructional steps defined for the medical procedure 310. In the illustrated example, the instructional step 323 instructs the user to advance the PICC from a first location 333A within the vasculature to a second location 333B within the vasculature.

[0076] The screenshot 303 includes pictorial illustration 332 related to the instructional step 323. In some embodiments, the pictorial illustration 332 may be chosen or defined from a database of historical live visual representations (i.e., live visual representations frozen and recorded during successful completions of the medical procedure) stored in the data repository 223. Accordingly, the pictorial illustration 332 may be logically linked to the instructional step 323. The screenshot 303 further includes a live visual representation 334 overlaid atop of the pictorial illustration 332. The pictorial illustration 332 and the live visual representation 334 are correspondingly sized via the logic to be the same. For example, the logic may adjust the scale of either or both of the pictorial illustration 332 and the live visual representation 334 such that a common reference portion (e.g., a portion of the patient) illustrated in both the pictorial illustration 332 and the live visual representation 334 are substantially equal in size. In a similar fashion, the logic may adjust the position or orientation of the either or both of the pictorial illustration 332 and the live visual representation 334 such that common reference portions (e.g., a shoulder, arm, or insertion site) are substantially aligned.

[0077] The pictorial illustration 332 illustrates a distal portion of the PICC 333 extending along the vasculature such that a distal end of the PICC 333 is located at the second location 333B consistent with the instructional step 323 having been completed. The live visual representation 334 illustrates a distal portion of the PICC 335 extending along the vasculature such that a distal end of the PICC 335 is located at the first location 333B consistent with the instructional step 323 not having been started. As such, during performance of the instructional step 323, the user can observe the distal end of the PICC 335 in the live visual representation 334 displacing alongside or atop the PICC 333 in the pictorial illustration 332 between the first location 333A and the second location 333B. As the location of the PICC can be magnetically tracked as described above, the logic can automatically determine when the distal end of the PICC 335 in the live visual representation 334 is located at the second position 333B, and therefore, the logic can determine when the instructional step 323 is completed. In a similar fashion, during performance of the instructional step 323, the user can observe the distal end of the PICC 335 in the live visual representation 334 displacing along the PICC 333 in the pictorial illustration 332 and determine if the PICC 335 in the live visual representation 334 deviates from the PICC 333 in the pictorial illustration 332. Similarly, via magnetic tracking, the logic can automatically determine when the PICC 335 in the live visual representation 334 deviates from the PICC 333 in the pictorial illustration 332.

[0078] FIG. 3D illustrates an example of a screenshot that may be portrayed on the display 111, according to some embodiments. The screen shot 304 provides instructions to the user for performing a medical procedure 310. The screen shot 304 may, in certain respects, resemble the screenshot 303. The screenshot 303 includes the instructional step 323 (i.e., a textual instruction) of a set of instructional steps defined for the medical procedure 310. In the illustrated example, the instructional step 323 instructs the user to advance the PICC from a first location 333A within the vasculature to a second location 333B within the vasculature as illustrated FIG. 3C.

[0079] The screenshot 304 includes pictorial illustration 342 related to the instructional step 323, a shape of the PICC 343. Similar to the pictorial illustration 332, the pictorial illustration 342 may be chosen or defined from a database of historical live visual representations (i.e., live visual representations frozen and recorded during a successful completions of the medical procedure) stored in the data repository 223. Accordingly, the pictorial illustration 342 may be logically linked to the instructional step 323. The screenshot 304 further includes a live visual representation 344 overlaid atop of the pictorial illustration 332 including a live shape 345 of the PICC. Similar to the pictorial illustration 332 and the live visual representation 334, the logic may size and align the pictorial illustration 342 and/or the live visual representation 344, such are substantially the same size and in alignment with each other.

[0080] The pictorial illustration 342 illustrates the shape 343 of the PICC consistent with the instructional step 323 having been completed. The live visual representation 344 illustrates the shape of the PICC 345 consistent with the instructional step 323 not having been started. As such, during performance of the instructional step 323, the user can observe the shape 345 the PICC 335 in the live visual representation 344 transitioning toward the shape 343 of the pictorial illustration 342. As the shape of the PICC can be optically determined in real time as described above, the logic can automatically determine when the shape 345 substantially matches the shape 343, and therefore, the logic can determine when the instructional step 323 is completed. In a similar fashion, during performance of the instructional step 323, the user can observe the shape 345 of the PICC in the live visual representation 344 during performance of the instructional step 323 and determine if the shape 345 is transitioning away from the shape 343. Similarly, via shape sensing, the logic can automatically determine when the shape 345 transitions away from the shape 343 and thereby, determine that the instructional step 323 is not being properly performed or has not been properly completed.

[0081] Some operations disclosed herein as performed by logic may include utilizing Artificial Intelligence (Al) and/or machine learning (ML) techniques such as techniques taught by U.S. application Ser. No. 17/981,313, filed Nov. 4, 2022, and entitled "Systems and Methods for Artificial Intelligence Enabled Ultrasound Correlation” which is incorporated herein by reference in its entirety.

[0082] The data repository 223 may include historical images (e.g., ultrasound images) of target areas, such as target areas including blood vessels. The historical images be used to determines characteristics of anatomical elements such as blood vessels by comparing live images of blood vessels with this historical images. The historical images may include or be linked with information about the blood vessels captured in the historical images, such as assessment or test results regarding the blood vessels. By way of example, blood vessels captured in various historical images may be located at different depths. As such, comparing a live image with a number of historical images may enable the logic to determine a depth of the blood vessel in the live image with a degree of confidence.

[0083] As discussed above in relation to FIGS. 3C, 3D, the logic can be configure determine when an instruction step has been completed by comparing an aspect of the live visual representation with a corresponding aspect of a pictorial illustration where the pictorial illustration includes a recorded historical image. Al techniques can enhance a confidence level for a conclusion based on the image comparison. Further examples of making determinations which can benefit from Al techniques are described below. [0084] To perform a blood vessel evaluation, an instructional step can instruct the user to compress the blood vessel. As veins compress more easily that arteries, comparing a live image of an unidentified compressed blood vessel with historical images (stored in the data repository 223) of identified compressed blood vessels (i.e., known veins and arteries) utilizing Al techniques can yield a result that the unidentified compressed blood vessel is vein or is an artery with a resulting confidence level.

[0085] To perform another blood vessel evaluation, an instructional step can instruct the user to scan up/down the vessel location. By comparing the live scan with corresponding historical scans utilizing Al techniques the logic can yield a result that the health, size, bifurcations, etc. meet defined characteristics with a resulting confidence level.

[0086] To evaluation the size and depth of the vein, an instructional step can instruct the user to obtain a live image of the vein and compare the live image with corresponding historical images of veins having known depths and sizes utilizing Al techniques. The logic can then yield a result that the depth and size of the vein are within defined ranges with a resulting confidence level.

[0087] To determine when a needle has accessed a vein, an instructional step can instruct the user to obtain a live image of the vein and needle and compare the live image with corresponding historical images of veins having at various known locations within the vein and not within the vein utilizing Al techniques. The logic can then yield a result that the needle has accessed the vein with a resulting confidence level.

[0088] To determine when a catheter tip is placed within the lower l/3^rd of the superior vena cava (SPV) an instructional step can instruct the user to obtain an ECG waveform via an electrode at the distal end of the catheter and compare the live ECG waveform with corresponding historical ECG waveforms obtained by ECG electrodes and various known locations along the SPV utilizing Al techniques. The logic can then yield a result that the catheter tip is placed within the lower l/3^rd of the SPV a resulting confidence level.

[0089] In some embodiments, Al techniques can be used to automatically navigate between screens and/or applications of the system 100 according to the instruction steps.

[0090] In some embodiments, the logic can provide buttons or prompts on the display 111, to capture and record procedural information portrayed on the display 111, such as exit site markings, or the cut length of a catheter, for example. Similarly, live images can be captured and stored in the database of historical images.

[0091] A method of providing instructions to a user for performing a medical procedure can include all or any subset of the following steps, actions, or processes, according to some embodiments. The method 400 includes selecting a medical procedure to be performed utilizing a medical system (block 410). In some embodiments of the method 400, selecting the medical procedure may include selecting the medical procedure from the database of medical procedures stored in a memory of the medical system. In some embodiments of the method 400, selecting the medical procedure is based on input received by the medical system, where the input includes one or more of: user-entered input received via a graphical user interface of the system; a voice command from the user received via a microphone of the medical system; a communication received from a network coupled with the system; or medical device information acquired from a medical device to be utilized in performing the medical procedure, where the medical device information is acquired by scanning the medical device via a scanning device of the medical system, and where the scanning device includes an RFID reader, a barcode reader, or a camera.

[0092] The method 400 further includes defining a set of instructional steps to be followed during the performance of the selected medical procedure (block 420). In some embodiments of the method 400, defining the set of the instructional steps includes acquiring one or more historical instructional steps from a database of historical instructional steps stored in the memory and incorporating the one or more historical instructional steps into the set of instructional steps. In some embodiments of the method 400, the one or more pictorial illustrations are acquired from a database of historical pictorial illustrations stored in the memory.

[0093] The method 400 further includes providing the set of instructional steps to the user of the medical system via an output module of the medical system (block 430). In some embodiments of the method 400, providing the set of instructional steps may include portraying on a display of the system each of the instructional steps in a textual form and portraying on the display one or more pictorial illustrations linked via logic of the medical system to one or more of the instructional steps, each pictorial illustration including one or more of a drawing, a picture, a diagram, a video, or an animation. In some embodiments of the method 400, providing the set of the instructional steps to the user may include audibly providing one or more of the instructional steps to the user via a speaker of the output module.

[0094] In some embodiments, the method 400 may further include modifying the set of the instructional steps based on user-entered input to create a custom set of instructional steps linked to the user (block 440). The user-entered input is provided to the medical system via the graphical user interface to define a custom set of instructional steps linked to the user. The modification may include at least one of: adding one or more instructional steps to the set of the instructional steps; removing one or more instructional steps from the set of the instructional steps; modifying one or more instructions steps of the set of the instructional steps; or modifying an order of the set of the instructional steps.

[0095] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. A medical system, comprising: a system module, comprising: an input module configured to receive input pertaining to medical procedures to be performed on a patient by a user utilizing the medical system; an output module configured to provide to the user instructions for performing the medical procedures; and a console coupled with the input module and the output module, the console including a processor and a memory having a logic stored thereon that, when executed by the processor, performs operations of the medical system, including: receiving the input via the input module; defining, based on the input, a set of the instructional steps to be followed during a performance of a selected medical procedure; and providing the set of instructional steps to the user via the output module.

2. The medical system according to claim 1, wherein: the output module includes a display, and providing the set of instructional steps to the user includes visually providing one or more of the instructional steps on the display.

3. The medical system according to claim 2, wherein visually providing the set of instructional steps on the display includes portraying one or more pictorial illustrations on the display, the pictorial illustrations including one or more of a drawing, a picture, a diagram, a video, or an animation.

4. The medical system according to any of preceding claims, wherein: the output module includes a speaker, and providing the set of the instructional steps to the user includes audibly providing one or more of the instructional steps to the user.

5. The medical system according to any of preceding claims, wherein the memory includes a database of medical procedures stored thereon, and the selected medical procedure is selected from the database of medical procedures.

6. The medical system according to any of preceding claims, wherein the memory includes a database of historical instructional steps stored thereon, and defining the set of the instructional steps includes incorporating one or more of the historical instructional steps into the set of the instructional steps.

7. The medical system according to any of claims 3-6 , wherein the memory includes a database of historical pictorial illustrations stored thereon, and defining the set of the instructional steps includes linking one or more instructional steps with one or more historical pictorial illustrations providing the set of instructional steps includes providing the one or more instructional steps with the one or more historical pictorial illustrations linked therewith.

8. The medical system according to any of the preceding claims, wherein: the user interface includes a microphone, and receiving the input includes receiving a voice command from the user.

9. The medical system according to any of the preceding claims, wherein the operations further include modifying the set of the instructional steps based on the user entered input via the user interface to define a custom set of instructional steps linked to the user, the modification including at least one of: adding one or more instructional steps to the set of the instructional steps; removing one or more instructional steps from the set of the instructional steps; modifying one or more instructions steps of the set of the instructional steps; or modifying an order of the set of the instructional steps.

10. The medical system according to any of the preceding claims, further comprising a medical device to be utilized during the performance of the medical procedure, the medical device configured for placement within a patient.

11. The medical system according to claim 10, wherein: the input module includes a scanning device chosen from an RFID reader, a barcode reader, or a camera, receiving the input includes scanning the medical device with the scanning device to acquire medical device information therefrom, and the medical device information includes the medical procedure or one or more instructional steps to be followed when performing the medical procedure utilizing the medical device.

12. The medical system according to any of the preceding claims, wherein: providing the set of instruction steps includes providing a second instruction step directly after providing a first instruction step, and the operations include: determining a completion of the first instructional step; and automatically providing the second instructional step after determining the completion of the first instruction step.

13. The medical system according to any of the preceding claims, further comprising an imaging probe, the imaging probe configured to: obtain a live image of a target area of the patient, and simultaneously portray the live image on the display along with providing the set of instructional steps.

14. The medical system according to claim 13, wherein the database of pictorial illustrations includes historical images of the target area, the historical images having been recorded by the medical system during previous performances of the medical procedure.

15. The medical system according to any of claims 3-14, further comprising a medical device tracking system including a magnetic field sensor coupled with the patient, the medical device tracking system configured to track the live location of the medical device during placement within the patient by magnetically tracking the location of a number of magnetic portions of the medical device with respect to the magnetic field sensor, and the operations include: providing a fourth instruction step including portraying on the display a fourth pictorial illustration linked to the fourth instruction step, the fourth pictorial illustration depicting the medical device at a second location; and overlaying a live visual representation of the medical device directly atop the fourth pictorial illustration, the live visual representation depicting the medical device at a first location within the patient consistent with completion of a third instructional step, wherein the fourth instruction step instructs the user to advance the medical device from the first location depicted in the live visual representation to the second location depicted in the fourth pictorial illustration.

16. The medical system according to any of the preceding claims, further comprising a shape sensing system configured to: determine a live shape of the medical device by determining a shape of an optical fiber coupled with the medical device, and simultaneously portray the live shape of the medical device on the display along with providing the set of instructional steps.

17. The medical system according to claim 16, wherein: the memory includes a database of historical shapes of the medical device stored thereon, the historical shapes including at least a first historical shape and a second historical shape different from the first historical shape, and the operations further include: comparing the live shape with the first and second historical shapes; determining from the comparison that the live shape matches the first historical shape and providing one subset of the set of instructional steps; and determining from the comparison that the live shape matches the second historical shape and providing a subset of the set of instructional steps different from the one subset.

18. A method of providing instructions for performing a medical procedure, comprising: selecting a medical procedure to be performed utilizing a medical system; defining a set of instructional steps to be followed during the performance of the selected medical procedure; and providing the set of instructional steps to a user of the medical system via an output module of the medical system.

19. The method according to claim 18, wherein providing the set of instructional steps includes portraying on a display of the system each of the instructional steps in a textual form and portraying on the display one or more pictorial illustrations linked via logic of the medical system to one or more of the instructional steps, each pictorial illustration including one or more of a drawing, a picture, a diagram, a video, or an animation.

20. The method according to claim 18 or claim 19, wherein providing the set of the instructional steps to the user includes audibly providing one or more of the instructional steps to the user via a speaker of the output module.

21. The method according to any of claims 18-20, wherein selecting medical procedure includes selecting the medical procedure from the database of medical procedures stored in a memory of the medical system.

22. The method according to any of claims 18-21, wherein defining the set of the instructional steps includes: acquiring one or more historical instructional steps from a database of historical instructional steps stored in the memory; and incorporating the one or more historical instructional steps into the set of instructional steps.

23. The method according to any of claims 19-22, wherein the one or more pictorial illustrations are acquired from a database of historical pictorial illustrations stored in the memory.

24. The method according to any of claims 18-23, wherein selecting the medical procedure is based on input received by the medical system, the input including one or more of: user-entered input received via a graphical user interface of the system, a voice command from the user received via a microphone of the medical system; a communication received from a network coupled with the system; or medical device information acquired from a medical device to be utilized in performing the medical procedure, the medical device information acquired by scanning the medical device via a scanning device of the medical system, and the scanning device including an RFID reader, a barcode reader, or a camera.

25. The method according to any of claims 18-24, further comprising modifying the set of the instructional steps based on user-entered input via the user graphical user interface to define a custom set of instructional steps linked to the user, the modification including at least one of adding one or more instructional steps to the set of the instructional steps; removing one or more instructional steps from the set of the instructional steps; modifying one or more instructions steps of the set of the instructional steps; or modifying an order of the set of the instructional steps.