Device, system and methods for real-time puncture angle measurement for vascular puncture

Abstract

Systems and methods enable a user to monitor the angular pitch of the vascular access device during vascular access using an inertial measurement unit (IMU). The IMU produces an initial angular pitch orientation of the vascular access device to generate a compensated angular pitch orientation. The IMU also produces an acceleration signal and an angular rate signal to determine an acceleration-based change and a rate-based change, respectively, in orientation of the vascular access device. A compensated change in orientation is generated based on a complement of the acceleration-based change in orientation and the rate-based change in orientation to compensate the initial angular pitch orientation of the vascular access device, which is displayed in real-time to the user.

Description

DEVICE, SYSTEM AND METHODS FOR REAL-TIME PUNCTURE ANGLE MEASUREMENT FOR VASCULAR PUNCTURECLAIM TO PRIORITY

[0001] This application claims priority to U.S. Provisional Application 63 / 638,683, titled “DEVICE, SYSTEM AND METHODS FOR REAL-TIME PUNCTURE ANGLE MEASUREMENT FOR VASCULAR PUNCTURE” and filed April 25, 2024.FIELD OF TECHNOLOGY

[0002] The present disclosure generally relates to computer-based devices, systems and methods for real-time measurement and monitoring of puncture angle of a syringe or other puncture device for vascular puncture.BACKGROUND OF TECHNOLOGY

[0003] Many medical procedures, treatments and / or regimens make use of cannulation to inject into a blood stream, extract from the blood stream, or both, such as blood testing, hemodialysis, intravenous fluid administration for medication, etc. However, inexperience with cannulation and associated risks are major barriers to patient care and limit adoption of home hemodialysis. Moreover, poor cannulation technique is a major cause of costly vascular access repair and revision procedures.SU ARY

[0004] In some aspects, the techniques described herein relate to a device including: a vascular access device comprising: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an inertial measurement unit (EMU) mounted to the needle hub, the IMU including: at least one accelerometer, at least one gyroscope, and at least one processing device; wherein the at least one processing device isconfigured to: receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, in real-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0005] In some aspects, the techniques described herein relate to a device, wherein the acceleration signal includes a 3-axis acceleration signal including: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

[0006] In some aspects, the techniques described herein relate to a device, wherein the angular rate signal includes a 3-axis angular rate signal including: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis.

[0007] In some aspects, the techniques described herein relate to a device, wherein the at least one processor is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system includes: determine, while the IMU is mountedto the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

[0008] In some aspects, the techniques described herein relate to a device, wherein the at least one processor is further configured to: cause to render, on a display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold includes at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device includes at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0009] In some aspects, the techniques described herein relate to a device, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication includes at least one graphical limit marker on the graphical scale of pitch.

[0010] In some aspects, the techniques described herein relate to a device, wherein the at least one processor is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

[0011] In some aspects, the techniques described herein relate to a system including: a display device; a vascular access device including: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an IMU mounted to the needle hub, the IMU including: at least one accelerometer, at least one gyroscope, and at least one processing device; wherein the at least one processing device is configured to:receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, in real-time, on the display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0012] In some aspects, the techniques described herein relate to a system, wherein the acceleration signal includes a 3-axis acceleration signal including: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

[0013] In some aspects, the techniques described herein relate to a system, wherein the angular rate signal includes a 3-axis angular rate signal including: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;

[0014] In some aspects, the techniques described herein relate to a system, wherein the at least one processor is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system includes: determine, while the IMU is mountedto the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

[0015] In some aspects, the techniques described herein relate to a system, wherein the at least one processor is further configured to: cause to render, on the display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold includes at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device includes at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0016] In some aspects, the techniques described herein relate to a system, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication includes at least one graphical limit marker on the graphical scale of pitch.

[0017] In some aspects, the techniques described herein relate to a system, wherein the at least one processor is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

[0018] In some aspects, the techniques described herein relate to a method including: receiving, by at least one processing device from at least one gyroscope, an initial angular pitch orientation; generating, by the at least one processing device, a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface;receiving, by the at least one processing device from at least one accelerometer, an acceleration signal and an angular rate signal; determining, by the at least one processing device, an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determining, by the at least one processing device, a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determining, by the at least one processing device, a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determining, by the at least one processing device, an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and rendering, by the at least one processing device, in real-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0019] In some aspects, the techniques described herein relate to a method, wherein: the acceleration signal includes a 3-axis acceleration signal including: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis; and the angular rate signal includes a 3-axis angular rate signal including: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;

[0020] In some aspects, the techniques described herein relate to a method, further including calibrating, by the at least one processing method, a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system includes: determining, by the at least one processing device, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in parton the compensated angular pitch orientation and the compensated change in orientation; and determining, by the at least one processing device, the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

[0021] In some aspects, the techniques described herein relate to a method, further including: causing to render, by the at least one processing device, on a display, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold includes at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device includes at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0022] In some aspects, the techniques described herein relate to a method, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication includes at least one graphical limit marker on the graphical scale of pitch.

[0023] In some aspects, the techniques described herein relate to a method, further including: determining, by the at least one processing device, a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Various embodiments of the present disclosure can be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the present disclosure. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variously employ one or more illustrative embodiments.

[0025] FIG. 1 depicts an access puncture angle measurement system for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure.

[0026] FIG. 2 depicts an illustrative computing system for a puncture angle monitoring device of the access puncture angle measurement system in accordance with one or more embodiments of the present disclosure.

[0027] FIG. 3 A and 3B depict illustrative vascular access devices including an angle sensor of the access puncture angle measurement system in accordance with one or more embodiments of the present disclosure.

[0028] FIG. 4 depicts an access puncture angle training system for real-time monitoring of access puncture angle during cannulation training in accordance with one or more embodiments of the present disclosure.

[0029] FIGs. 5A and 5B depict an access puncture angle training system for real-time monitoring of access puncture angle during cannulation training in accordance with one or more embodiments of the present disclosure.

[0030] FIGs. 6A and 6B depict measurements using the vascular access device according to exemplary coordinate systems in accordance with one or more embodiments of the present disclosure.

[0031] FIG. 7 depicts a block diagram of an exemplary computer-based system and platform for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure.

[0032] FIG. 8 depicts an example user interface for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure.

[0033] FIG. 9 depicts an example user interface for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0034] Various detailed embodiments of the present disclosure, taken in conjunction with the accompanying FIGs., are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative. In addition, each of the examples given in connection with the various embodiments of the present disclosure is intended to be illustrative, and not restrictive.

[0035] Throughout the specification, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases “in one embodiment” and “in some embodiments” as used herein do not necessarily refer to the same embodiment(s), though it may. Furthermore, the phrases “in another embodiment” and “in some other embodiments” as used herein do not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments may be readily combined, without departing from the scope or spirit of the present disclosure.

[0036] In addition, the term "based on" is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of "a," "an," and "the" include plural references. The meaning of "in" includes "in" and "on."

[0037] As used herein, the terms “and” and “or” may be used interchangeably to refer to a set of items in both the conjunctive and disjunctive in order to encompass the full description of combinations and alternatives of the items. By way of example, a set of items may be listed withthe disjunctive “or,” or with the conjunction “and.” In either case, the set is to be interpreted as meaning each of the items singularly as alternatives, as well as any combination of the listed items.

[0038] FIGs. 1 through 9 illustrate systems and methods of cannulation assistance via real-time measurement and display of one or more vascular access devices such a syringe or needle during cannulation. The following embodiments provide technical solutions and technical improvements that overcome technical problems, drawbacks and / or deficiencies in the technical fields vascular administration of medication, hemodialysis, blood testing, among other treatments and / or medical practices using cannulation, such technical problems, drawbacks and / or deficiencies involving “dumb” vascular access devices that do not provide any functionality or capability to measure an angle of puncture during cannulation, and thus requiring human guesswork and estimation based on experience to successfully cannulate with the vascular access device.

[0039] As explained in more detail, below, technical solutions and technical improvements herein include aspects of improved an access puncture angle measurement device provide with a vascular access device, the access puncture angle measurement device outputting real-time and / or continuous measurements of puncture angle during cannulation, thus improving the vascular access device for improved administration of medical treatments, therapies and / or tests.

[0040] Further, the improved vascular access device may include further technical improvements including a testing apparatus that works in conjunction with the access puncture angle measurement device to provide a training tool for patients doing home dialysis and dialysis technicians who cannulate patients in clinic.

[0041] Additionally, the improved vascular access device may include further technical improvements including an angle measurement sensor and / or ultrasound mapping to map thevascular access and determine the proper angle of insertion in three-dimensional coordinates for a given patient.

[0042] Additionally, the improved vascular access device may include further technical improvements including incorporating Doppler ultrasound to the device to provide flow rate measurements of the patient's access to provide early detection of access stenosis or impending failure to enable earlier intervention.

[0043] Based on such technical features, further technical benefits become available to users and operators of these systems and methods. Moreover, various practical applications of the disclosed technology are also described, which provide further practical benefits to users and operators that are also new and useful improvements in the art.

[0044] FIG. 1 depicts an access puncture angle measurement system for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure.

[0045] An access puncture angle measurement system 100 may include a vascular access device 110 having an angle sensor 114 for real-time measurement and display of an angle of the vascular access device 110. The angle may be displayed via a display 122 of a puncture angle monitoring device 120.

[0046] The vascular access device 110 may include a syringe, needle, catheter, cannula, or other device configured to achieve vascular access for cannulation of a vein, artery or other blood vessel. The vascular access device 110 may include a plug 112 for connecting the vascular access device 110 to a canula or other tube. Thus, the vascular access device 1 10 may include reusable and / or disposable vascular access devices.

[0047] The angle sensor 114 may include a connector corresponding to the plug 112 such that the connector may connect the angle sensor 114 to the vascular access device 110. The connector maybe an adapter or other device configured to connect to the plug 1 12 in-line with the canula such that a fluid flowing through the canula may flow through the connector into the plug 112 and through the vascular access device 110, or vice versa (e.g., in the case of drawing blood, etc.).

[0048] The angle sensor 114 measures the angle in a three-dimensional coordinate system of the connector, and thus of the vascular access device 110. For example, the angle sensor 114 may include a 3-axis accelerometer, a 3-axis gyroscope, or a combination thereof (e.g., a 6-axis inertial measurement unit “IMU”), or other sensor(s) for measuring movement and / or orientation in one or more dimensions. Indeed, where orientation is characterized by pitch, roll and yaw, where pitch is angle of elevation relative to a horizontal axis, roll and an angle of rotation about a longitudinal axis of the vascular access device 110, and yaw is an angle of rotation in a horizontal plane, the pitch and / or yaw may be the angle of interest for vascular access to ensure the vascular access device 110 is aligned in two or three dimensions with the blood vessel. Thus, the angle sensor 114 may be configured to measure pitch and / or pitch change via one or more accelerometer and / or gyroscope sensors or other IMU.

[0049] The measurements of the angle sensor 114 may be output to the puncture angle monitoring device 120. As further detailed below with respect to FIG. 2, the puncture angle monitoring device 120 may include a computing device for receiving the raw measurements of the angle sensor 114 and generating continuously or periodically updatable angle measurements of a current angle of the vascular access device 110. The display 122 of the puncture angle monitoring device 120 may depict a user interface showing the real-time angle measurements of the current angle. The user interface may also depict a target angle such that the user may identify the difference of the current angle of the vascular access device 110 to the target angle, and thus visualize how to adjust theorientation of the vascular access device 110 in order to achieve a target angle that is optimal for vascular access.

[0050] In some embodiments, the display 122 may include a real-time image, e.g., from a camera or image sensor mounted to the vascular access device 110, of the access site. In some embodiments, the real-time image may include a video feed having indicators superimposed thereon that depict the relative yaw and pitch of the vascular access device 110 relative to the blood vessel. In some embodiments, the video feed may include processing using an object detection machine learning model trained to detect the blood vessel in the access site. The detected blood vessel may be oriented in the three-dimensional coordinate system and the pitch and yaw of the vascular access device 110 may be measured relative to the orientation of the detected blood vessel. Based on the pitch and yaw, the indicators may be generated to represent the pitch and yaw in real time so as to show to the user the instantaneous orientation of the vascular access device 110 relative to an indicator for the target angle.

[0051] In some embodiments, instead of or in addition to showing the relative angle, indicators and / or target angle on the display 122, the vascular access device 110 may be equipped with a projection component configured to project the indicators from the vascular access device 110 onto the access site. The indicators may identify the current instantaneous pitch and yaw of the vascular access device 110, the location and orientation of the detected blood vessel, and / or the target angle. For example, the indicators may include linear or curved markings projected onto the access site to represent the location and orientation of each item. In some embodiments, the projection component may include, e.g., an LED, laser or any other means of projecting the angle onto the skin of the patient. In some embodiments, the projection component may be integrated orotherwise attached to a sensor board, needle hub or other portion of the vascular access device 1 10(see, e.g., FIGs. 3A and / or 3B).

[0052] FIG. 2 depicts an illustrative computing system for a puncture angle monitoring device of the access puncture angle measurement system in accordance with one or more embodiments of the present disclosure.

[0053] The angle sensor 114 of the vascular access device 110 may produce raw measurements of angle, orientation and / or acceleration of the vascular access device 110. The puncture angle monitoring device 120 may receive the raw measurements and process the raw measurements, e.g., using a calibration engine 130 to calibrate the raw measurements, and a coordinate transformation engine 140 to map the local coordinates of the raw measurements to a global coordinate system.

[0054] The puncture angle monitoring device 120 may include hardware components such as a processor 126, which may include local or remote processing components. The processor 126 may include any type of data processing capacity, such as a hardware logic circuit, for example an application specific integrated circuit (ASIC) and a programmable logic, or such as a computing device, for example, a microcomputer or microcontroller that include a programmable microprocessor. The processor 126 may include data-processing capacity provided by the microprocessor. The microprocessor may include memory, processing, interface resources, controllers, and counters. The microprocessor may also include one or more programs stored in memory.

[0055] Similarly, the puncture angle monitoring device 120 may include data store 124, such as one or more local and / or remote data storage solutions such as, e.g., local hard-drive, solid-state drive, flash drive, database or other local data storage solutions or any combination thereof, and / or remote data storage solutions such as a server, mainframe, database or cloud services, distributeddatabase or other suitable data storage solutions or any combination thereof. The data store 124 may include, e.g., a suitable non-transient computer readable medium such as, e.g., random access memory (RAM), read only memory (ROM), one or more buffers and / or caches, among other memory devices or any combination thereof.

[0056] The puncture angle monitoring device 120 may implement computer engines for calibration of the raw measurements and coordinate transformation to map the angle measurements to a global coordinate system. The terms “computer engine” and “engine” identify at least one software component and / or a combination of at least one software component and at least one hardware component which are designed / programmed / configured to manage / control other software and / or hardware components (such as the libraries, software development kits (SDKs), objects, etc.).

[0057] Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth. The one or more processors may be implemented as a Complex Instruction Set Computer (CISC) or Reduced Instruction Set Computer (RISC) processors; x86 instruction set compatible processors, multi- core, or any other microprocessor or central processing unit (CPU). In various implementations, the one or more processors may be dual-core processor(s), dual-core mobile processor(s), and so forth.

[0058] Examples of software may include software components, programs, applications, computer programs, application programs, system programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures,software interfaces, application program interfaces (API), instruction sets, computing code, computer code, code segments, computer code segments, words, values, symbols, or any combination thereof. Determining whether an embodiment is implemented using hardware elements and / or software elements may vary in accordance with any number of factors, such as desired computational rate, power levels, heat tolerances, processing cycle budget, input data rates, output data rates, memory resources, data bus speeds and other design or performance constraints.

[0059] The calibration engine 130 and / or the coordinate transformation engine 140 may include dedicated and / or shared software components, hardware components, or a combination thereof. For example, the calibration engine 130 and / or the coordinate transformation engine 140 may include a dedicated processor and storage. However, the calibration engine 130 and / or the coordinate transformation engine 140 may share hardware resources, including the processor 126 and data store 124 of the puncture angle monitoring device 120 via, e.g., a bus 128.

[0060] The angle sensor 114 may include an IMU that measures inertial features such as acceleration, orientation and / or angular velocity, among others or any combination thereof. For example, the IMU may include an accelerometer. An accelerometer is a tool that measures proper acceleration, which may be defined as the acceleration (the rate of change of velocity) of a body in its own instantaneous rest frame, and is different from coordinate acceleration, which is acceleration in a fixed coordinate system. Two or more accelerometers may be coordinated with one another to measure differences in proper acceleration, such as gravity, over separation in space between the accelerometers, e.g., the gradient of the gravitational field. Gravity gradiometry is useful because absolute gravity is a weak effect and depends on the local density of the Earth, which is variable. Single- and multi-axis accelerometers can detect both the magnitude and the direction of the proper acceleration, as a vector quantity, and can be used to sense orientation(because the direction of weight changes), coordinate acceleration, vibration, shock, and falling in a resistive medium (a case in which the proper acceleration changes, increasing from zero). The accelerometers may include micromachined microelectromechanical systems (MEMS) accelerometers to detect changes in the positions of devices via electronic means.

[0061] A gyroscope is a device used for measuring or maintaining orientation and angular velocity. The gyroscope may include a spinning wheel or disc in which the axis of rotation (spin axis) is free to assume any orientation by itself. When rotating, the orientation of this axis is unaffected by tilting or rotation of the mounting, according to the conservation of angular momentum. The gyroscope may include one or more additional or alternative operating principles, such as the microchip-packaged microelectromechanical systems (MEMS) gyroscopes found in electronic devices (sometimes called gyrometers), solid-state ring lasers, fiber optic gyroscopes, the quantum gyroscopes, among others or any combination thereof.

[0062] The IMU may include one or more accelerometers and / or one or more gyroscopes to measure raw measurements of acceleration, orientation and / or angular velocity, e g., in the instantaneous rest frame of the vascular access device 110 (see, for example, FIG. 6A). The instantaneous rest frame may or may not be indicative of the movement and / or orientation of the vascular access device 110 relative to a vascular structure to be accessed by the vascular access device 110. Accordingly, the puncture angle monitoring device 120 may calibrate the instantaneous rest frame to enable conversion of the instantaneous rest frame to a global coordinate system that relates to the vascular structure (see, for example, FIG. 6B).

[0063] The term “vascular structure” may refer to an actual vein, artery or other vascular structure of a patient and / or an artificial or simulated vein, artery or other vascular structure, e.g., of atraining simulator for training users for vascular access techniques, including optimal puncture angle for cannulation.

[0064] To calibrate the angle measurements, the calibration engine 130 may use zero-angle offset measurements for use in offsetting the instantaneous rest frame (also termed “sensor” or “local” coordinate system). To generate the zero-angle offset measurement, the calibration engine 130 may initiate a calibration procedure whereby the user is instructed, via the display 122, to place the angle sensor 114 in a calibration position.

[0065] The calibration position may include a calibration block to which the angle sensor 114 may be connected. The calibration block may be configured to hold the angle sensor 114 in a particular orientation relative to a calibration surface, such as, e.g., parallel to the calibration surface, orthogonal to the calibration surface, or other angle or any combination thereof. The calibration surface may be a flat horizontal calibration surface or a calibration surface beneath which the vascular structure is located (e.g., an arm, leg, or other anatomy, or a training simulator, or other calibration surface or any combination thereof.

[0066] For example, the calibration block may hold the angle sensor 114, when in the calibration position, at an angle relative to the calibration surface that corresponds to a target angle. The target angle may refer to an optimal angle at which puncture may be made for cannulation without additional damage or discomfort outside of the puncture itself. In another example, the calibration block may hold the angle sensor 114 parallel to the calibration surface such that a global coordinate system may be established where the horizontal plane (e.g., the x-y plane) is common to the calibration surface and the zero-angle offset of the angle sensor 114 such that the target angle may be a same angle relative to the calibration surface and the zero-angle offset.

[0067] Upon placing the angle sensor 114 in the calibration block, the calibration engine 130 may receive the raw angle measurements from the angle sensor and determine a difference between the raw angle measurements and a “zero degree” angle, e.g., establishing the calibration surface as a zero degree plane. Thus, the difference may be used as an offset value to determine the angle relative to the zero degree angle of the calibration surface based on the raw angle measurements.

[0068] The calibration block may be a part of the angle sensor 114. For example, a side of the angle sensor 114 may include a flat surface which may be placed in contact with the calibration surface. The flat surface may be parallel to a longitudinal axis of the angle sensor connector, and thus parallel to a longitudinal axis of the needle of the vascular access device 110, though other orientations may be employed. Using a flat surface formed on the angle sensor 114 may reduce the need for a separate calibration block. Thus, the angle sensor 114 may be laid against the calibration surface to determine the zero degree offset of the raw angle measurements relative to the calibration surface.

[0069] The calibration engine 130 may record the zero degree offset based on a user input to the user interface, the user input indicating that the angle sensor 114 is in the position for calibration as instructed by the display 122. where a calibration block is used, the calibration block may include a switch, button, sensor or other trigger mechanism to detect that the angle sensor 114 has been attached so as to automatically initiate the calibration engine 130 to record the zero degree offset.

[0070] Using the raw sensor measurements and the zero degree offset, the coordinate transformation engine 140 may transform the raw sensor measurements from the local coordinate system of the angle sensor 114 to a global coordinate system. The global coordinate system may include, e.g., cartesian coordinates, polar coordinates, or other coordinate system for harmonizingthe measurements of the angle sensor 114 with the orientation of the vascular structure as per the zero-degree offset produced by the calibration engine 130.

[0071] The raw sensor measurements may include axis-specific accelerations and / or angular rates for one or more axes. For example, the IMU may be a 6-axis IMU with 3 acceleration axes and 3 angular rate axes. The coordinate transformation engine 140 may determine one or more axisspecific angles from the acceleration(s) and / or angular rate(s), such as pitch, roll and / or yaw (e.g., rotation about the y, x and z axes, respectively, or, put another way, angle relative to the z axis for pitch, within the x-y plane for yaw and about the x axis for roll). To do so, the coordinate transformation engine 140 may use the acceleration(s) and one or more trigonometric functions such an arctangent (“atan” or “arctan”) and / or two-argument atan (“atan2”). For example, the coordinate transformation engine 140 may determine a pitch based on accelerometer measurements relative to x and z axes (Ax and Az, respectively) using atan2 as per Equation 1 below:PitchA(rad) = atan2(— Ax, Az) Eq. 1

[0072] where pA is the pitch angle according to acceleration and the z axis is set as the direction of gravity.

[0073] Similarly, the coordinate transformation engine 140 may determine a roll angle based on accelerometer measurements relative to x and y axes (Ax and Ay, respectively) using atan2 as per Equation 2 below:Eq. 2

[0074] where 6 A is the roll angle according to acceleration.

[0075] Alternatively or additionally, the coordinate transformation engine 140 may use gyroscope measurements of angular rate in the x-, y- and / or z- axes (Gx, Gy and / or Gz, respectively) to determine axis-specific angles. To do so, the coordinate transformation engine 140 may convert the angular rates to Euler angular form to convert the local coordinate system measurements of the raw angular measurements to the global coordinate system. For example, to generate the pitch angle according to gyroscope measurement ( pG\ the coordinate transformation engine 140 may integrate the angular rate and convert to Euler angular form according to Equation 3 below: s (pre(p) X tan (pre9) x Gy (preG) x Gz) x (AT)

[0076] where pre(p is a previous pitch angle, pre0 is a previous roll angle, and AT is a time since a previous calculation.

[0077] Similarly, to generate the roll angle according to gyroscope measurement (GG), the coordinate transformation engine 140 may integrate the angular rate and convert to Euler angular form according to Equation 4 below:RollG(ra ) = pred -I- (cos (pre<p) x Gy — sin (pre p) x Gz) x (AT) Eq. 4

[0078] It may be observed that the pitch and / or roll angle in the global coordinate system of the angle sensor 114 may be dependent on a previous measurement, thus updating the pitch and / or roll angle through time as the raw angular measurements are received, e.g., according to a sampling rate of the sensor (e.g., 1, 2, 5, 10, 12, 15, 20, 22, 25, 30, 60, or more Hertz (Hz)). As such, thedetermined pitch and / or roll angle may be dependent on an initial condition. The coordinate transformation engine 140 may use the zero degree offset of the calibration engine 130 as the initial condition for use in the conversion of the gyroscope-based angular measurements to the global coordinate system. Similarly, the coordinate transformation engine 140 may use the zero degree offset of the calibration engine 130 to offset the pitch and / or roll angles calculated from acceleration measurements, e.g.,. by subtracting axis-specific offsets of the zero degree offsets from the pitch and / or roll angle.

[0079] While calculating an angle from accelerometer measurements is accurate, such calculations may be sensitive to rapid movement, while angle calculated from angular rates of a gyroscopic measurements are resistant to rapid movements, such calculations may be prone to drift. Accordingly, the angles calculated by acceleration measurements and gyroscopic measurements may be reconciled to leverage the accuracy and drift resistance of accelerometer based angle calculations while avoiding rapid movement induced inaccuracy with the gyroscope based angle calculations. The acceleration measurements and gyroscopic measurements may be reconciled using any suitable aggregation function, such as a sum, average, weighted sum, weighted average, or other function. For example, Equations 5 and 6 below may be used to aggregated acceleration measurements and gyroscopic measurements for pitch and roll angles, respectively:Pitcher at ) = a x <pG -I- b x <p AEq. 6Pitch0(rad) = c x 0G + d x 0AEq. 7

[0080] where a, b, c, and d are weighting coefficients, such that a and b add up to 1, and c and d add up to 1. a may be 0.7 and b may be 0.3, and similarly c may be 0.7 and d may be 0.3, though other coefficients may be used. For example, the coefficients may balance accuracy and drift resistance against resistance to rapid movements, where a and c influence accuracy and drift resistance while b and d influence resistance to rapid movements. Thus, the values chosen may depend on the application and which sensor performance feature is to be emphasized. Accordingly,

[0081] As detailed above, the zero degree offset may be used to offset the accelerometer-based and gyroscope-based calculations individually. Alternatively or in addition, the coordinate transformation engine 140 may offset the combined accelerometer-based and gyroscope-based measurements of each of pitch and roll.

[0082] The pitch and roll as detailed above are calculated in radians. Degrees may be a more understandable unit for angular measurements for a user. Accordingly, the coordinate transformation engine 140 may convert the angle measurements in radians to degrees, e.g., by 180 multiplying the angle by 180 over pi (degrees = — -). The final measurement of pitch and / or roll pt may be output to the display 122 in real time to inform the user of the current, real-time angle of the vascular access device 110 relative to the vascular structure, pitch, as the angle of the angle sensor 114 relative to a horizontal, is indicative of the puncture angle of the vascular access device 110. Accordingly, at least the pitch may be displayed on the display 122. Thus, the user may ascertain the puncture angle of the vascular access device 110 when performing cannulation to ensure that the target angle is achieved to reduce damage and discomfort to the patient.

[0083] The angle sensor 114 may be used in conjunction with an ultrasonic device 116. The ultrasonic device 116 may use ultrasound to map anatomical structures in a patient, such as thevascular structures of a patient’s arm, leg, abdomen, chest, or other portion of the body or any combination thereof. The ultrasonic device 116 uses ultrasonic acoustic waves to map depth of structures at each location on a surface of the body. Thus, the ultrasonic device 116 maps the structures (e.g., the vascular structures) of the body in three-dimensions, two dimensions corresponding to location on the surface of the portion of the body, and a third dimension for the depth of the structure(s).

[0084] The mapping may be, e.g., one or more point clouds, one or more grids of “pixels” with each pixel having the depth data, or other form of three dimensionally mapping the structures or any combination thereof. Accordingly, the mapping may be in a three dimensional coordinate system local to the ultrasonic device 116.

[0085] The coordinate transformation engine 140 may receive the mapping from the ultrasonic device 116 and convert the coordinates to the global coordinate system. As a result, the coordinate transformation engine 140 may locate each of the angle sensor 114 and the ultrasonic device 116 within a common global coordinate system. The global coordinate system may be equivalent to the ultrasonic device 116 local coordinate system, the angle sensor 114 local coordinate system, or different coordinate system. For example, the coordinate transformation engine 140 may use the local coordinate system of the ultrasonic device 116 as the global coordinate system such that the coordinate transformation detailed above for the angle sensor 114 may be configured to transform the local coordinate system of the angle sensor 114 to the local coordinate system of the ultrasonic device 116 so as to locate and determine the angle of the angle sensor 1 14 relative to the mapping produced by the ultrasonic device 116.

[0086] Thus, as detailed above, the coordinate transformation engine 140 may receive raw sensor measurements corresponding to three axes in order to determine pitch and roll, thus determiningthe angle of the vascular access device 1 10 about two axes. The coordinate transformation engine140 may also calculate angle about a third axis (yaw), e.g., about the z axis as depicted in FIG. 6A below. Therefore, the coordinate transformation engine 140 may determine the orientation of the vascular access device 110 in three dimensions, such as in the global coordinate system. Accordingly, the orientation of the puncture angle monitoring device 120 relative to the mapping of the vascular structures of the portion of the patient’s body may be determined so as to measure, in real-time, the orientation of the vascular access device 110 relative to the vascular structures for more accurate puncture at the optimal orientation corresponding to minimized damage and discomfort to the patient.

[0087] FIG. 3A and 3B depict illustrative vascular access devices including an angle sensor of the access puncture angle measurement system in accordance with one or more embodiments of the present disclosure.

[0088] The vascular access device 110 may include the plug 112 and the angle sensor 114. The angle sensor 114 may be attached to a connection part such as a male luer connector. The male luer connector may be inserted into a female luer connector of a needle, which may be connected to the needle via a needle hub, as shown in FIG. 3A.

[0089] The angle sensor 114, as depicted in FIG. 3B, may be attached to a connection part (such as a male luer connector) configured to be inserted into an IV plug for connection of a cannula to the IV plug. The IV plug may connect to the luer connector of the needle hub via inserted into the female luer connector of the needle hub.

[0090] FIG. 4 depicts an access puncture angle training system for real-time monitoring of access puncture angle during cannulation training in accordance with one or more embodiments of the present disclosure.

[0091] The puncture angle monitoring device 120 may be incorporated into an access puncture angle training system 200. The access puncture angle training system 200 may be configured to assist in training of users to puncture a body part, such as an arm, at an optimal orientation and with an optimal force so as to achieve vascular access with minimal damage and / or discomfort. To do so, the access puncture angle training system 200 may include a puncture site 210 having a simulated vessel 214 (e.g., blood vessel) covered by artificial skin 212.

[0092] The artificial skin 212 may include a flexible material having a puncture resistance approximately equal to that of natural human skin. Accordingly, the artificial skin 212 may include one or more fabric and / or polymer membranes having a thickness and strength sufficient to mimic the puncture resistance of natural human skin. For example, needle-resistant materials may be pierced by a force between 2-10 N by a 25 gauge needle perpendicular to the fabric. The forces in the EN 388 test results are rated according to a score from 0-4 (0, <20 N; 1, 20 N; 2, 60 N; 3, 100 N; 4, >150 N). A newer test, ASTM F2878-10, is specifically designed to simulate common hypodermic needles in 21-, 25-, 28- gauge. Thus, the artificial skin may have an approximately equivalent puncture resistance according to the EN 388 and / or ASTM F2878-10 tests as natural human skin, similar to the artificial skin 212, the simulated vessel 214 may be formed of a material having a thickness and strength resulting in a similar puncture resistance to a human blood vessel.

[0093] The simulated vessel 214 may be a segment of tubing having a diameter approximately equivalent to a diameter of a blood vessel, e.g., in a human arm. For example, the simulated vessel 214 may be a tube having a diameter equal to the average male and / or female vein of an arm for which cannulation is generally attempted, e.g., for drawing blood, administering intravenous (IV) fluid, dialysis, etc., though other target blood vessels may be simulated with correspondingly sized tubing. Indeed, the simulated vessel 214 may be replaceable such that new simulated vessels 214may be inserted upon puncture during training and / or to replace the simulated vessel 214 with a differently sized simulated vessel 214 that more closely matches the target blood vessel of a particular patient or group of patients.

[0094] As detailed above, the puncture angle monitoring device 120 may be connected to the display 122 to render a user interface thereon depicting the orientation of the vascular access device 110 based on sensor measurements from the angle sensor 114. The calibration surface for calibration of the angle sensor 114 may be the surface o the puncture site 210, and the vascular structure may be the simulated vessel 214. Thus, the puncture angle monitoring device 120 may be configured to receive the sensor measurements from the angle sensor 114 and calculate the puncture angle (e.g., the pitch and / or yaw) of the vascular access device 110 relative to the simulated vessel 214.

[0095] The access puncture angle training system 200 may include a “preview” button 240 that initiates a preview of the vascular access procedure. The preview button 240 causes the puncture angle monitoring device 120 to initiate a preview routine whereby the user interface of the display 122 depicts a preview of the vascular access procedure, including a depiction of the angle of the vascular access device 110 during puncture. For example, the user interface may display an animation or recording of the vascular access procedure being performed along with an animation and / or recording of the angle measurements throughout the vascular access procedure.

[0096] The access puncture angle training system 200 may include a power button 230 to turn on and / or off the angle sensor 114, puncture angle monitoring device 120, display 122 and / or the whole access puncture angle training system 200 or other components or any combination thereof.

[0097] FIGs. 5A and 5B depicts an access puncture angle training system for real-time monitoring of access puncture angle during cannulation training in accordance with one or more embodiments of the present disclosure.

[0098] As detailed above, the access puncture angle training system 200 may include the puncture angle monitoring device 120, display 122 and simulated vessel 214. The access puncture angle training system 200 may include load cells to measure force in one or more directions during vascular access, e.g., to measure the force of the vascular access device 110 against the puncture site 210.

[0099] The load cells may include a load cell y 220 for measuring load in a y direction. Thus, the load cell y 220 may measure the force of the puncture parallel to a direction along which the simulated vessel 2148 extends so as to measure the y component of the puncture force during vascular access. Additionally or alternatively, the load cells may include a load cell z 218 for measuring load in a z direction. Thus, the load cell z 218 may measure the force of the puncture perpendicular (e.g., vertically perpendicular) to a direction along which the simulated vessel 214 extends so as to measure the z component, or downward component, of the puncture force during vascular access.

[0100] To facilitate measurement of load, e.g., in the z direction, the access puncture angle training system 200 may include a linear guide 216 on which the puncture site 210 is positions. Accordingly, the puncture site 210 and / or the simulated vessel 214 may be mounted to the linear guide 216, e.g., via a mounting component, such that the mounting component may shift under load along the direction of the linear guide 216. The ability to shift facilitates the load cell measuring the load of the puncture. The linear guide 216 may extend along the z direction so as to facilitate measurement of load by the load cell z 218.

[0101] The display 122 may display the load measurements from each of the load cell y 220 and the load cell z 218 throughout the vascular access procedure. The display 122 may graphically and / or numerically represent the load in the y direction, the z direction, and / or the total force as a function of the load in both the y and z directions (see, for example, the user interfaces of FIGs. 8 and / or 9).

[0102] A microcontroller and analog-digital (AD) converter 250 (hereinafter “microcontroller 250”) may be housed within the access puncture angle training system 200. The microcontroller 250 may receive sensor signals from the load cells 218 and 220 and output load measurements to the display 122. The microcontroller 250 may be any suitable processing device such as a hardware logic circuit, for example an application specific integrated circuit (ASIC) and a programmable logic, or such as a computing device, for example, a microcomputer or microcontroller that include a programmable microprocessor. The processing device may include data-processing capacity provided by the microprocessor. The microprocessor may include memory, processing, interface resources, controllers, and counters. The microprocessor may also include one or more programs stored in memory. The microcontroller 250 may be and / or include the puncture angle monitoring device 120 detailed above with reference to FIG. 2, or may be a separate device, or any combination thereof.

[0103] FIG. 6A and 6B depict measurements using the vascular access device according to exemplary coordinate systems in accordance with one or more embodiments of the present disclosure.

[0104] The angle sensor 114 may take inertial measurements in three dimensions. The three dimensions may include a local coordinate system 600 defined by Cartesian coordinates having an x, y and z axis. For example, the angle sensor 114 may include an accelerometer that measuresacceleration in an x direction along the x axis of the local coordinate system 600 (“Accel. X”), acceleration in a y direction along the y axis of the local coordinate system 600 (“Accel. Y”), and acceleration in a z direction along the z axis of the local coordinate system 600 (“Accel. Z”). Additionally or alternatively, the angle sensor 114 may include a gyroscope that measures angular rate or rotation about the x axis of the local coordinate system 600 (“Gyro X”), angular rate or rotation about the y axis of the local coordinate system 600 (“Gyro Y”), and angular rate or rotation about the z axis of the local coordinate system 600 (“Gyro Z”).

[0105] The local coordinate system 600 may be converted into a global coordinate system 610, e.g., via the coordinate transformation engine 140 as detailed above. Accordingly, the measurements may be used to determine the orientation of the angle sensor 114, and thus the vascular access device 110, in real-time within the global coordinate system 610.

[0106] FIG. 7 depicts a block diagram of another exemplary computer-based system and platform 700 for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure. However, not all of these components may be required to practice one or more embodiments, and variations in the arrangement and type of the components may be made without departing from the spirit or scope of various embodiments of the present disclosure. The client device 702a, client device 702b through client device 702n shown each at least includes a computer-readable medium, such as a random-access memory (RAM) 708 coupled to a processor 710 or FLASH memory, and may include the puncture angle monitoring device 120 and / or an external computing device connected to the access puncture angle measurement system 100 and / or access puncture angle training system 200. The processor 710 may execute computerexecutable program instructions stored in memory 708. The processor 710 may include a microprocessor, an ASIC, and / or a state machine. The processor 710 may include, or may be incommunication with, media, for example computer-readable media, which stores instructions that, when executed by the processor 710, may cause the processor 710 to perform one or more steps described herein, examples of computer-readable media may include, but are not limited to, an electronic, optical, magnetic, or other storage or transmission device capable of providing a processor, such as the processor 710 of client device 702a, with computer-readable instructions, other examples of suitable media may include, but are not limited to, a floppy disk, CD-ROM, DVD, magnetic disk, memory chip, ROM, RAM, an ASIC, a configured processor, all optical media, all magnetic tape or other magnetic media, or any other medium from which a computer processor can read instructions. Also, various other forms of computer-readable media may transmit or carry instructions to a computer, including a router, private or public network, or other transmission device or channel, both wired and wireless. The instructions may comprise code from any computer-programming language, including, for example, C, C++, Visual Basic, Java, Python, Perl, JavaScript, and etc.

[0107] Client devices 702a through 702n may also comprise a number of external or internal devices such as a mouse, a CD-ROM, DVD, a physical or virtual keyboard, a display, or other input or output devices, examples of client devices 702a through 702n (e.g., clients) may be any type of processor-based platforms that are connected to a network 706 such as, without limitation, personal computers, digital assistants, personal digital assistants, smart phones, pagers, digital tablets, laptop computers, Internet appliances, and other processor-based devices, client devices 702a through 702n may be specifically programmed with one or more application programs in accordance with one or more principles / methodol ogies detailed herein, client devices 702a through 702n may operate on any operating system capable of supporting a browser or browser-enabled application, such as Microsoft™, Windows™, and / or Linux, client devices 702a through 702nshown may include, for example, personal computers executing a browser application program such as Microsoft Corporation's Internet Explorer™, Apple Computer, Inc.'s Safari™, Mozilla Firefox, and / or Opera. Through the member computing client devices 702a through 702n, user 712a, user 712b through user 712n, may communicate over the exemplary network 706 with each other and / or with other systems and / or devices coupled to the network 706. As shown in FIG. 7, exemplary server devices 704 and 713 may include processor 705 and processor 714, respectively, as well as memory 717 and memory 716, respectively. The server devices 704 and 713 may be also coupled to the network 706. one or more client devices 702a through 702n may be mobile clients.

[0108] At least one database of exemplary databases 707 and 715 may be any type of database, including a database managed by a database management system (DBMS). An exemplary DBMS- managed database may be specifically programmed as an engine that controls organization, storage, management, and / or retrieval of data in the respective database. The exemplary DBMS- managed database may be specifically programmed to provide the ability to query, backup and replicate, enforce rules, provide security, compute, perform change and access logging, and / or automate optimization. The exemplary DBMS-managed database may be chosen from Oracle database, IBM DB2, Adaptive Server Enterprise, FileMaker, Microsoft Access, Microsoft SQL Server, MySQL, PostgreSQL, and a NoSQL implementation. The exemplary DBMS-managed database may be specifically programmed to define each respective schema of each database in the exemplary DBMS, according to a particular database model of the present disclosure which may include a hierarchical model, network model, relational model, object model, or some other suitable organization that may result in one or more applicable data structures that may includefields, records, files, and / or objects. The exemplary DBMS-managed database may be specifically programmed to include metadata about the data that is stored.

[0109] The exemplary inventive computer-based systems / platforms, the exemplary inventive computer-based devices, and / or the exemplary inventive computer-based components of the present disclosure may be specifically configured to operate in a cloud computing / architecture 725 such as, but not limiting to: infrastructure a service (laaS), platform as a service (PaaS), and / or software as a service (SaaS) using a web browser, mobile app, thin client, terminal emulator or other endpoint.

[0110] FIG. 8 depicts an example user interface for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure. The user interface of FIG.8 may be implemented on an embedded device, such as the puncture angle monitoring device 120 detailed above. The user interface may include a view for real-time monitoring of the angle of the vascular access device, a settings view for adjusting settings of the system(s), a calibration view for performing calibration of the angle sensor 114, a data comparison view and a preview view.[0U1] FIG. 9 depicts an example user interface for real-time monitoring of access puncture angle in accordance with one or more embodiments of the present disclosure. The user interface of FIG.9 may be implemented on a computing, e.g., via an application or webpage or both. The user interface may include a view for real-time monitoring of the angle of the vascular access device and imagery (e.g., during training, for ultrasound-based vascular mapping, etc.), and an analysis view for viewing vascular access measurement data after completion of cannulation, such as angle history, min, max and mean of angle and / or force, among other data or any combination thereof.

[0112] It is understood that at least one aspect / functionality of various embodiments described herein can be performed in real-time and / or dynamically. As used herein, the term “real-time” isdirected to an event / action that can occur instantaneously or almost instantaneously in time when another event / action has occurred. For example, the “real-time processing,” “real-time computation,” and “real-time execution” all pertain to the performance of a computation during the actual time that the related physical process (e.g., a user interacting with an application on a mobile device) occurs, in order that results of the computation can be used in guiding the physical process.

[0113] As used herein, the term “dynamically” and term “automatically,” and their logical and / or linguistic relatives and / or derivatives, mean that certain events and / or actions can be triggered and / or occur without any human intervention, events and / or actions in accordance with the present disclosure can be in real-time and / or based on a predetermined periodicity of at least one of: nanosecond, several nanoseconds, millisecond, several milliseconds, second, several seconds, minute, several minutes, hourly, several hours, daily, several days, weekly, monthly, etc.

[0114] Exemplary inventive, specially programmed computing systems and platforms with associated devices are configured to operate in the distributed network environment, communicating with one another over one or more suitable data communication networks (e.g., the Internet, satellite, etc.) and utilizing one or more suitable data communication protocols / modes such as, without limitation, IPX / SPX, X.25, AX.25, AppleTalk(TM), TCP / IP (e.g., HTTP), near- field wireless communication (NFC), RFID, Narrow Band Internet of Things (NBIOT), 3G, 4G, 5G, GSM, GPRS, WiFi, WiMax, CDMA, satellite, ZigBee, and other suitable communication modes.

[0115] The material disclosed herein may be implemented in software or firmware or a combination of them or as instructions stored on a machine-readable medium, which may be read and executed by one or more processors. A machine-readable medium may include any mediumand / or mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device). For example, a machine-readable medium may include read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.), and others.

[0116] As used herein, the terms “computer engine” and “engine” identify at least one software component and / or a combination of at least one software component and at least one hardware component which are designed / programmed / configured to manage / control other software and / or hardware components (such as the libraries, software development kits (SDKs), objects, etc.).

[0117] Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth. The one or more processors may be implemented as a Complex Instruction Set Computer (CISC) or Reduced Instruction Set Computer (RISC) processors; x86 instruction set compatible processors, multi-core, or any other microprocessor or central processing unit (CPU). In various implementations, the one or more processors may be dual-core processor(s), dual-core mobile processor(s), and so forth.

[0118] Computer-related systems, computer systems, and systems, as used herein, include any combination of hardware and software. Examples of software may include software components, programs, applications, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, application program interfaces (API), instruction sets, computer code, computer code segments, words, values,symbols, or any combination thereof. Determining whether an embodiment is implemented using hardware elements and / or software elements may vary in accordance with any number of factors, such as desired computational rate, power levels, heat tolerances, processing cycle budget, input data rates, output data rates, memory resources, data bus speeds and other design or performance constraints.

[0119] One or more aspects of at least one embodiment may be implemented by representative instructions stored on a machine-readable medium which represents various logic within the processor, which when read by a machine causes the machine to fabricate logic to perform the techniques described herein. Such representations, known as “IP cores,” may be stored on a tangible, machine readable medium and supplied to various customers or manufacturing facilities to load into the fabrication machines that make the logic or processor. Of note, various embodiments described herein may, of course, be implemented using any appropriate hardware and / or computing software languages (e.g., C++, Objective-C, Swift, Java, JavaScript, Python, Perl, QT, etc.).

[0120] One or more of illustrative computer-based systems or platforms of the present disclosure may include or be incorporated, partially or entirely into at least one personal computer (PC), laptop computer, ultra-laptop computer, tablet, touch pad, portable computer, handheld computer, palmtop computer, personal digital assistant (PDA), cellular telephone, combination cellular telephone / PDA, television, smart device (e.g., smart phone, smart tablet or smart television), mobile internet device (MID), messaging device, data communication device, and so forth.

[0121] As used herein, term “server” should be understood to refer to a service point which provides processing, database, and communication facilities. By way of example, and not limitation, the term “server” can refer to a single, physical processor with associatedcommunications and data storage and database facilities, or it can refer to a networked or clustered complex of processors and associated network and storage devices, as well as operating software and one or more database systems and application software that support the services provided by the server. Cloud servers are examples.

[0122] As detailed herein, one or more of the computer-based systems of the present disclosure may obtain, manipulate, transfer, store, transform, generate, and / or output any digital object and / or data unit (e.g., from inside and / or outside of a particular application) that can be in any suitable form such as, without limitation, a fde, a contact, a task, an email, a message, a map, an entire application (e.g., a calculator), data points, and other suitable data. As detailed herein, one or more of the computer-based systems of the present disclosure may be implemented across one or more of various computer platforms such as, but not limited to: (1) FreeBSD, NetBSD, OpenBSD; (2) Linux; (3) Microsoft Windows™; (4) Open VMS™; (5) OS X (MacOS™); (6) UNIX™; (7) Android; (8) iOS™; (9) Embedded Linux; (10) Tizen™; (11) WebOS™; (12) Adobe AIR™; (13) Binary Runtime Environment for Wireless (BREW™); (14) Cocoa™ (API); (15) Cocoa™ Touch; (16) Java™ Platforms; (17) JavaFX™; (18) QNX™; (19) Mono; (20) Google Blink; (21) Apple WebKit; (22) Mozilla Gecko™; (23) Mozilla XUL; (24) .NET Framework; (25) Silverlight™; (26) Open Web Platform; (27) Oracle Database; (28) Qt™; (29) SAP NetWeaver™; (30) Smartface™; (31) Vexi™; (32) Kubernetes™ and (33) Windows Runtime (WinRT™) or other suitable computer platforms or any combination thereof, illustrative computer-based systems or platforms of the present disclosure may be configured to utilize hardwired circuitry that may be used in place of or in combination with software instructions to implement features consistent with principles of the disclosure. Thus, implementations consistent with principles of the disclosure are not limited to any specific combination of hardware circuitry and software. For example, variousembodiments may be embodied in many different ways as a software component such as, without limitation, a stand-alone software package, a combination of software packages, or it may be a software package incorporated as a “tool” in a larger software product.

[0123] For example, exemplary software specifically programmed in accordance with one or more principles of the present disclosure may be downloadable from a network, for example, a website, as a stand-alone product or as an add-in package for installation in an existing software application. For example, exemplary software specifically programmed in accordance with one or more principles of the present disclosure may also be available as a client-server software application, or as a web-enabled software application. For example, exemplary software specifically programmed in accordance with one or more principles of the present disclosure may also be embodied as a software package installed on a hardware device.

[0124] Illustrative computer-based systems or platforms of the present disclosure may be configured to handle numerous concurrent users that may be, but is not limited to, at least 100 (e g., but not limited to, 100-999), at least 1,000 (e g., but not limited to, 1,000-9,999 ), at least 10,000 (e.g., but not limited to, 10,000-99,999 ), at least 100,000 (e.g., but not limited to, 100,000-999.999), at least 1,000,000 (e.g., but not limited to, 1,000,000-9,999,999), at least 10,000,000 (e.g., but not limited to, 10,000,000-99,999,999), at least 100,000,000 (e.g., but not limited to, 100,000,000-999,999,999), at least 1,000,000,000 (e.g., but not limited to, 1,000,000,000-999.999.999.999), and so on.

[0125] Illustrative computer-based systems or platforms of the present disclosure may be configured to output to distinct, specifically programmed graphical user interface implementations of the present disclosure (e.g., a desktop, a web app., etc.). In various implementations of the present disclosure, a final output may be displayed on a displaying screen which may be, withoutlimitation, a screen of a computer, a screen of a mobile device, or the like. Tn various implementations, the display may be a holographic display. In various implementations, the display may be a transparent calibration surface that may receive a visual projection. Such projections may convey various forms of information, images, or objects. For example, such projections may be a visual overlay for a mobile augmented reality (MAR) application.

[0126] Illustrative computer-based systems or platforms of the present disclosure may be configured to be utilized in various applications which may include, but not limited to, gaming, mobile-device games, video chats, video conferences, live video streaming, video streaming and / or augmented reality applications, mobile-device messenger applications, and others similarly suitable computer-device applications.

[0127] As used herein, the term “mobile electronic device,” or the like, may refer to any portable electronic device that may or may not be enabled with location tracking functionality (e.g., MAC address, Internet Protocol (IP) address, or the like). For example, a mobile electronic device can include, but is not limited to, a mobile phone, Personal Digital Assistant (PDA), Blackberry ™, Pager, Smartphone, or any other reasonable mobile electronic device.

[0128] the illustrative computer-based systems or platforms of the present disclosure may be configured to securely store and / or transmit data by utilizing one or more of encryption techniques (e.g., private / public key pair, Triple Data Encryption Standard (3DES), block cipher algorithms (e.g., IDEA, RC2, RC5, CAST and Skipjack), cryptographic hash algorithms (e.g., MD5, RIPEMD-160, RTRO, SHA-1, SHA-2, Tiger (TTH), WHIRLPOOL, RNGs).

[0129] As used herein, the term “user” shall have a meaning of at least one user. The terms “user”, “subscriber” “consumer” or “customer” should be understood to refer to a user of an application or applications as described herein and / or a consumer of data supplied by a data provider. By wayof example, and not limitation, the terms “user” or “subscriber” can refer to a person who receives data provided by the data or service provider over the Internet in a browser session, or can refer to an automated software application which receives the data and stores or processes the data.

[0130] The aforementioned examples are, of course, illustrative and not restrictive.

[0131] At least some aspects of the present disclosure will now be described with reference to the following numbered clauses.

[0132] Clause 1. A device comprising: a vascular access device comprising: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an inertial measurement unit (IMU) mounted to the needle hub, the IMU comprising: at least one accelerometer, at least one gyroscope, and at least one processing device; wherein the at least one processing device is configured to: receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, inreal-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0133] Clause 2. The device of clause 1, wherein the acceleration signal comprises a 3 -axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

[0134] Clause 3. The device of clause 1, wherein the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;

[0135] Clause 4. The device of clause 1, wherein the at least one processor is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determine, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zerodegree offset angle of the pitch.

[0136] Clause 5. The device of clause 1, wherein the at least one processor is further configured to: cause to render, on a display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0137] Clause 6. The device of clause 5, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

[0138] Clause 7. The device of clause 1, wherein the at least one processor is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

[0139] Clause 8. A system comprising: a display device; a vascular access device comprising: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an IMU mounted to the needle hub, the IMU comprising: at least one accelerometer, at least one gyroscope, and at least one processing device; wherein the at least one processing device is configured to: receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, inreal-time, on the display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0140] Clause 9. The system of clause 8, wherein the acceleration signal comprises a 3-axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

[0141] Clause 10. The system of clause 8, wherein the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;

[0142] Clause 11. The system of clause 8, wherein the at least one processor is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determine, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zerodegree offset angle of the pitch.

[0143] Clause 12. The system of clause 8, wherein the at least one processor is further configured to: cause to render, on the display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0144] Clause 13. The system of clause 12, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

[0145] Clause 14. The system of clause 8, wherein the at least one processor is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

[0146] Clause 15. A method comprising: receiving, by at least one processing device from at least one gyroscope, an initial angular pitch orientation; generating, by the at least one processing device, a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to the calibration surface; receiving, by the at least one processing device from at least one accelerometer, an acceleration signal and an angular rate signal; determining, by the at least one processing device, an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determining, by the at least one processing device, a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determining, by the at least one processing device, a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determining, by the at least one processing device, an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and rendering, by the at least one processing device, in real-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

[0147] Clause 16. The method of clause 15, wherein: the acceleration signal comprises a 3-axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis; and the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;

[0148] Clause 17. The method of clause 15, further comprising calibrating, by the at least one processing method, a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determining, by the at least one processing device, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determining, by the at least one processing device, the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

[0149] Clause 18. The method of clause 15, further comprising: causing to render, by the at least one processing device, on a display, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

[0150] Clause 19. The method of clause 18, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

[0151] Clause 20. The method of clause 15, further comprising: determining, by the at least one processing device, a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

[0152] Publications cited throughout this document are hereby incorporated by reference in their entirety. While one or more embodiments of the present disclosure have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art, including that various embodiments of the inventive methodologies, the illustrative systems and platforms, and the illustrative devices described herein can be utilized in any combination with each other. Further still, the various steps may be carried out in any desired order (and any desired steps may be added and / or any desired steps may be eliminated).

Claims

CLAIMSWhat is claimed is:

1. A device comprising: a vascular access device comprising: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an inertial measurement unit (IMU) mounted to the needle hub, the IMU comprising: at least one accelerometer, at least one gyroscope, and at least one processing device; wherein the at least one processing device is configured to: receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to a calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal;determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the ratebased change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, in real-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

2. The device of claim 1, wherein the acceleration signal comprises a 3-axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

3. The device of claim 1, wherein the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, anda third angular rate about a third axis;4. The device of claim 1, wherein the at least one processing device is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determine, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

5. The device of claim 1, wherein the at least one processing device is further configured to: cause to render, on a display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

6. The device of claim 5, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

7. The device of claim 1, wherein the at least one processing device is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

8. A system comprising: a display device; a vascular access device comprising: a needle portion with a needle connector, and a needle hub having a mating connector that is configured to mate with the needle connector; an IMU mounted to the needle hub, the IMU comprising: at least one accelerometer, at least one gyroscope, and at least one processing device;wherein the at least one processing device is configured to: receive, from the at least one gyroscope, an initial angular pitch orientation; generate a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to a calibration surface; receive from the at least one accelerometer, an acceleration signal and an angular rate signal; determine an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determine a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determine a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the ratebased change in orientation; determine an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and render, in real-time, on the display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

9. The system of claim 8, wherein the acceleration signal comprises a 3-axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis.

10. The system of claim 8, wherein the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;11. The system of claim 8, wherein the at least one processing device is further configured to calibrate a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determine, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determine the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

12. The system of claim 8, wherein the at least one processing device is further configured to: cause to render, on the display device, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

13. The system of claim 12, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

14. The system of claim 8, wherein the at least one processing device is further configured to: determine a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

15. A method comprising:receiving, by at least one processing device from at least one gyroscope of an inertial measurement unit (IMU) of a vascular access device, an initial angular pitch orientation; generating, by the at least one processing device, a compensated angular pitch orientation based at least in part on applying an angular pitch offset to the initial angular pitch orientation so as to establish an angle of a pitch of the vascular access device with respect to a calibration surface; receiving, by the at least one processing device from at least one accelerometer, an acceleration signal and an angular rate signal; determining, by the at least one processing device, an acceleration-based change in orientation of the vascular access device based at least in part on the acceleration signal; determining, by the at least one processing device, a rate-based change in orientation of the vascular access device based at least in part on the angular rate signal; determining, by the at least one processing device, a compensated change in orientation based at least in part on a complement of the acceleration-based change in orientation and the rate-based change in orientation; determining, by the at least one processing device, an updated angle of a pitch of the vascular access device with respect to the calibration surface based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and rendering, by the at least one processing device, in real-time, on a display the updated angle of the pitch of the vascular access device with respect to the calibration surface.

16. The method of claim 15, wherein:the acceleration signal comprises a 3-axis acceleration signal comprising: a first angular acceleration about a first axis, a second angular acceleration about a second axis, and a third angular acceleration about a third axis; and the angular rate signal comprises a 3-axis angular rate signal comprising: a first angular rate about a first axis, a second angular rate about a second axis, and a third angular rate about a third axis;17. The method of claim 15, further comprising calibrating, by the at least one processing device, a sensor coordinate system using a calibration block, wherein calibrating the sensor coordinate system comprises: determining, by the at least one processing device, while the IMU is mounted to the calibration block, a zero-degree offset angle of the pitch of the vascular access device with respect to the calibration block based at least in part on the compensated angular pitch orientation and the compensated change in orientation; and determining, by the at least one processing device, the angular pitch offset based at least in part on the zero-degree offset angle of the pitch.

18. The method of claim 15, further comprising:causing to render, by the at least one processing device, on a display, an indication of at least one pitch threshold associated with an allowable pitch of the vascular access device, wherein the at least one pitch threshold comprises at least one of: a maximum pitch threshold value, or a minimum pitch threshold value; and wherein the display device comprises at least one of a monitor or a projector configured to produce imagery indicative of the updated angle of the pitch and the at least one pitch threshold.

19. The method of claim 18, wherein the updated angle of the pitch is rendered as a marker on a graphical scale of pitch, and wherein the indication comprises at least one graphical limit marker on the graphical scale of pitch.

20. The method of claim 15, further comprising: determining, by the at least one processing device, a global updated angle of the pitch of vascular access device based at least in part on converting the updated angle of a pitch from a sensor coordinate system to a global coordinate system using Euler angles.

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