Patent Description:
<CIT> discloses a catheter including a proximal portion designed for residing externally of a patient vasculature and a distal portion having a distal tip designed for placement in a desired position within the patient vasculature. A storage component is embedded in a portion of the catheter, the storage component including a radio-frequency identification (RFID) chip. The RFID chip includes non-volatile memory that is programmable by a RFID encoder.

<CIT> discloses a system comprising a controller system and an endoscopic image capture device with a fiber optic bundle leading to a connector. The endoscopic image capture device also comprises a read-only memory, such as a RFID tag, that stores calibration data for the endoscopic image capture device. The connector of the endoscopic image capture device is configured to connect with a socket of the controller system. A RFID reader may be coupled to the controller system and configured to read the memory of the endoscopic image capture device.

<CIT> discloses an implantable unique device identifier and detection system.

<CIT> discloses an intelligent catheter.

<CIT> discloses systems and methods for locating and identifying an implanted medical device.

Claim <NUM> defines an RFID enabled medical device system according to the invention. The dependent claims define preferred embodiments.

Embodiments disclosed herein are directed to radio frequency identification ("RFID") enabled medical devices, systems and associated methods thereof. An RFID tag can be coupled with a medical device and can be interrogated by an RFID emitter to determine information about the medical device. This information can be used to automatically update an external computing system, console, or the like, can track a location of the medical device, or monitor correct usage of the medical device. Information about the usage of one or more medical devices can be used to monitor compliance or improve future systems.

Disclosed herein is an RFID enabled medical device system including, an RFID tag associated with a medical device, and an RFID emitter communicatively coupled with a console configured to provide an interrogation signal that can impinge on the RFID tag to induce a response signal, the response signal configured to provide information to the console about the medical device.

The medical device is a fiber optic stylet configured to map a vascular pathway and the RFID tag is disposed within a hub disposed at a proximal end of the stylet. In some embodiments, the information provided to the console includes calibration information. The RFID emitter may be configured to trigger the response signal when the RFID tag is within a range of between <NUM> and <NUM>. The RFID emitter may be configured to trigger the response signal when the RFID tag is within a range of less than <NUM>. The RFID emitter is configured to induce the response signal when the hub of the stylet is coupled to a connector that is communicatively coupled with the console.

In some embodiments, the medical device is disposed within a packaging and the RFID tag is disposed on the packaging. The RFID tag provides calibration information for the medical device to the console. The medical device can include one of an indwelling device, a procedural device, a packaging of the medical device, a maintenance device, or a personnel identification equipment. The information provided to the console includes one of medical device identification, medical device specification information, personnel information, analytics information, compliance information, post-procedure and identification information, or automatic device update information. The RFID emitter is configured to write information to the RFID tag. In some embodiments, information written to the RFID tag includes one of medical device identification, medical device specification information, personnel information, analytics information, compliance information, post-procedure and identification information, or automatic device update information.

Also disclosed herein is an RFID enabled medical device kit including, a tray including a compartment configured to contain a medical device, a RFID tag associated with one of the tray or the medical device, and an RFID emitter communicatively coupled to a console and configured to provide an interrogation signal that can impinge on the RFID tag to trigger a response signal, the response signal configured to provide information to the console about the tray or the medical device.

In some embodiments, the RFID emitter is disposed within a support surface configured to support the tray. The support surface includes a table, a cart, a rolling stand, or a flexible membrane. The RFID emitter is disposed within the tray. The RFID emitter is configured to provide a first interrogation signal which can induce a first response signal from a first medical device and a second response signal from a second medical device. A first RFID emitter is configured to provide a first interrogation signal which can induce a first response signal from a first medical device and a second RFID emitter is configured to provide a second interrogation signal which can induce a second response signal from a second medical device.

In some embodiments, the RFID emitter is configured to trigger the response signal when the RFID tag is within a range of less than <NUM>. The medical device can include one of an indwelling device, a procedural device, a packaging of the medical device, a maintenance device, or a personnel identification equipment. The information provided to the console includes one of medical device identification, medical device specification information, personnel information, analytics information, compliance information, post-procedure and identification information, or automatic device update information. The RFID emitter is configured to write information to the RFID tag. In some embodiments, information written to the RFID tag includes one of medical device identification, medical device specification information, personnel information, analytics information, compliance information, post-procedure and identification information, or automatic device update information. In some embodiments, the RFID enabled medical device kit further includes an AR viewer communicatively coupled to the console and configured to provide an image overlay of the medical device kit to indicate an order in which a first medical device and a second medical device is used.

Also disclosed is an optically enabled medical device system including, a tray including a compartment configured to contain a medical device, a camera configured to image an upper surface of one of the tray or the medical device, and a console communicatively coupled to the camera and configured to receive the image from the camera and determine a presence or an absence of a medical device from the kit.

In some embodiments the compartment includes a symbol, barcode, or QR code that is detectable by the camera when the medical device is absent from the compartment, the console configured to interpret information about the medical device from the symbol, barcode, or QR code. In some embodiments, the optically enabled medical device system further includes an AR viewer communicatively coupled to the console and configured to provide an image overlay of the medical device kit to indicate an order in which a first medical device and a second medical device is used.

Also disclosed is a method of calibrating a medical device system including, providing an interrogation signal by an RFID emitter communicatively coupled to a console, impinging the interrogation signal on an RFID tag coupled to a medical device, providing information about the medical device, encoded within a response signal, to the console, and calibrating the console to the medical device using the information encoded within the response signal.

In some embodiments, the medical device is a fiber optic stylet configured to map a vascular pathway and the RFID tag is disposed within a hub disposed at a proximal end of the stylet. The RFID emitter is configured to induce the response signal when the RFID tag is within a range of less than <NUM>.

Also disclosed is a method of using a medical device kit including, providing a first interrogation signal from an RFID emitter that is communicatively coupled with a console, triggering a first response signal from an RFID tag by the interrogation signal impinging on the RFID tag, the RFID tag coupled to a medical device, determining a start time when the interrogation signal fails to trigger a response signal, and determining a finish time when the interrogation signal triggers a response signal.

In some embodiments, the first interrogation signal triggers a second response signal from a second RFID tag coupled to a second medical device. A second interrogation signal triggers a second response signal from a second RFID tag coupled to a second medical device. The medical device includes one of an indwelling device, a procedural device, a packaging of the medical device, a maintenance device, or a personnel identification equipment. The console receives and determines information about the kit including one of medical device identification, medical device specification information, personnel information, analytics information, compliance information, post-procedure and identification information, or automatic device update information.

Also disclosed is an RFID enable ultrasound system including, an ultrasound console having an ultrasound probe communicatively coupled thereto, and an RFID emitter communicatively coupled with the ultrasound console and configured to provide an interrogation signal that can impinge on a RFID tag disposed on a medical device to induce a response signal, the response signal configured to provide information to the ultrasound console about the medical device.

In some embodiments, the medical device is part of a medical device kit, the medical device kit includes a second RFID tag configured to provide a second response signal in response to the interrogation signal. The RFID emitter is disposed on the ultrasound probe. The ultrasound console includes an image recognition logic communicatively coupled to one of an optical camera, an ultrasound logic, or a user interface display logic to determine information about one of the medical device, a medical device kit, a clinician or a patient.

Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein and that the invention is defined by the appended claims.

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

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

In the following description, certain terminology is used to describe aspects of the invention. For example, in certain situations, the term "logic" is representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, logic may include circuitry having data processing or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor with one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit "ASIC," etc.), a semiconductor memory, or combinatorial elements.

Alternatively, logic may be software, such as executable code in the form of an executable application, an Application Programming Interface (API), a subroutine, a function, a procedure, an applet, a servlet, a routine, source code, object code, a shared library/dynamic load library, or one or more instructions. The software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; semiconductor memory; non-persistent storage such as volatile memory (e.g., any type of random access memory "RAM"); or persistent storage such as non-volatile memory (e.g., read-only memory "ROM," power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the executable code may be stored in persistent storage.

The term "computing device" should be construed as electronics with the data processing capability and/or a capability of connecting to any type of network, such as a public network (e.g., Internet), a private network (e.g., a wireless data telecommunication network, a local area network "LAN", etc.), or a combination of networks. Examples of a computing device may include, but are not limited or restricted to, the following: a server, an endpoint device (e.g., a laptop, a smartphone, a tablet, a "wearable" device such as a smart watch, augmented or virtual reality viewer, or the like, a desktop computer, a netbook, a medical device, or any general-purpose or special-purpose, user-controlled electronic device), a mainframe, internet server, a router; or the like.

A "message" generally refers to information transmitted in one or more electrical signals that collectively represent electrically stored data in a prescribed format. Each message may be in the form of one or more packets, frames, HTTP-based transmissions, or any other series of bits having the prescribed format.

The term "computerized" generally represents that any corresponding operations are conducted by hardware in combination with software and/or firmware.

As shown in <FIG>, and to assist in the description of embodiments described herein, a longitudinal axis extends substantially parallel to an axial length of a fiber optic stylet <NUM>. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes.

The present disclosure relates generally to RFID or optically enabled medical devices, systems and associated methods. <FIG> shows an exemplary RFID enabled medical device system ("system") <NUM>. The system <NUM> generally includes an external computing device ("console") <NUM> including an RFID emitter <NUM> and a medical device <NUM> that includes an RFID tag <NUM>. As used herein the external computing device <NUM> can include a console, workstation, computer, laptop, handheld device, mobile device, or the like configured to receive, analyze, or display information received from one or more of the medical device(s) <NUM> or from additional networked computing devices communicatively coupled thereto, as described in more detail herein. In the context of the claimed invention, the medical device <NUM> is be a fiber optic stylet ("stylet") <NUM>. In an embodiment, the medical device <NUM> can be a disposable, single use medical device. However, it will be appreciated that, in further examples useful to understand the claimed invention, this is not intended to be limiting and the medical device <NUM> can include various other medical devices, as described in more detail herein.

The fiber optic stylet <NUM> can be supported by a stylet hub <NUM> and include the RFID tag <NUM> disposed therein. In an embodiment, the RFID tag <NUM> can be disposed on a packaging <NUM> that contains the medical device <NUM>. In an embodiment, the medical device <NUM> can include a first RFID tag 140A disposed on the stylet <NUM> and a second RFID tag 140B disposed on the packaging <NUM>. In an embodiment, the stylet <NUM> can be configured to be disposed within a lumen of a needle, cannula, catheter, introducer, or the like. As shown, the stylet <NUM> is disposed within a lumen of an introducer <NUM> however this is not intended to be limiting. In an embodiment, a distal portion of the stylet <NUM> can be configured to extend into a vasculature of the patient. The fiber optic stylet <NUM> can be configured to map a tortuous pathway through the vasculature of the patient by determining a location or angle of flexion along an axis of the stylet <NUM>. As will be appreciated, the fiber optic stylet <NUM> is exemplary and other modalities of mapping a vessel including impedance, conductance, or ultrasonic modalities are also contemplated.

The stylet hub <NUM> can be configured to couple to a connector <NUM> that is communicatively coupled to the console <NUM>. The connector <NUM> provides fiber optic communication between the stylet <NUM> and the console <NUM>. The console <NUM> can then be configured to receive and interpret optical signals from the stylet <NUM> to determine a map of the tortuous pathway through the vasculature. In an embodiment, the connector <NUM> can be coupled with different types of medical devices <NUM>, e.g. different types of fiber optic stylet <NUM>, medical devices <NUM>, or the like.

In an embodiment, the connector <NUM> of the console <NUM> can include an RFID emitter <NUM> configured to provide an interrogation signal <NUM>. The interrogation signal <NUM> can be a radio frequency electro-magnetic wave and can impinge on the RFID tag <NUM>, associated with the medical device <NUM>, e.g. within the stylet hub <NUM> or on the packaging <NUM>. The interrogation signal <NUM> can induce or trigger a response signal <NUM> from the RFID tag <NUM> that can be received by the RFID emitter <NUM>. In an embodiment, the RFID tag <NUM> can be a passive RFID tag that does not require any additional power source to provide a response signal <NUM>. Instead, the interrogation signal <NUM> provides sufficient energy to actuate the RFID tag <NUM> and trigger a response signal <NUM>. In an embodiment, the response signal <NUM> is a reflected interrogation signal <NUM> indicating the presence or absence of the RFID tag <NUM> within a predetermined range from the RFID emitter <NUM>. Exemplary ranges between the RFID emitter <NUM> and the RFID tag <NUM>, which can induce a response signal can be: < <NUM>, between <NUM> and <NUM>, between <NUM> and <NUM>, or greater than <NUM>. However, it will be appreciated that greater or lesser ranges or different combinations of ranges are also contemplated.

In an embodiment, the response signal <NUM> includes additional or different information from the interrogation signal <NUM>. The information can be stored on the RFID tag <NUM> and encoded to the response signal <NUM>. In an embodiment, the RFID emitter <NUM> can "read" information from the RFID tag <NUM> that is encoded within the response signal <NUM>. Exemplary information stored on the RFID tag <NUM> can include information about the medical device <NUM> such as make, model, batch number, serial number, dimensions, specifications, calibration information, combinations thereof, or the like, as described in more detail herein.

In an embodiment, the RFID emitter <NUM> can "write" information to the RFID tag <NUM>. The information can be transferred to the RFID tag <NUM>, encoded within the interrogation signal <NUM>, to be store thereon. Exemplary information to transfer to the RFID tag <NUM> can include patient information, date, time, system information, console information, combinations thereof, or the like, as described in more detail herein. In an embodiment, the information transferred to the RFID tag <NUM> can then be provided to the RFID emitter <NUM> at a later time, or to a different RFID emitter 120A.

In an embodiment, the medical device <NUM> can be configured to write information to the RFID tag <NUM>. The RFID emitter <NUM> can then read this information from the RFID tag <NUM> and transfer the information to the console <NUM>. For example, a medical device <NUM> can be configured to determine a number of times a needle is inserted to the patient. Optionally, the medical device <NUM>, tracking system, or the like can record additional information, e.g. a needle insertion location or the like and either write this information to the RFID tag <NUM> or communicate the information directly to the console <NUM>.

The RFID emitter <NUM> can be triggered to provide an interrogation signal <NUM>. The RFID emitter <NUM> is triggered by the console <NUM> to provide an interrogation signal <NUM>, for example when information about a medical device <NUM> is required. Generally speaking, the RFID emitter <NUM> can be triggered in response to an action, or at a given time or time interval. In the context of the claimed invention, the RFID emitter <NUM> is triggered to provide an interrogation signal <NUM> when the medical device <NUM> is coupled with the connector <NUM>. In a different embodiment useful to understand the claimed invention, the RFID emitter <NUM> can be triggered to provide an interrogation signal <NUM> when the medical device <NUM> is disposed proximate the connector <NUM>, or are disposed within the same sterile field. In a different embodiment useful to understand the claimed invention, the RFID emitter <NUM> can provide a constant interrogation signal <NUM>. In an embodiment, one of the interrogation signal <NUM> or the response signal <NUM> can cross a sterile barrier to enter or exit a sterile field. For example, the medical device <NUM> can remain within a sterile field while the console <NUM> and connector <NUM> can remain outside of the sterile field.

Advantageously, the RFID emitter <NUM> can interrogate the RFID tag <NUM> while the medical device <NUM> is still disposed within the packaging <NUM>. The console <NUM> can then determine the correct medical device <NUM> before being removed from the packaging <NUM>. Optionally, the packaging <NUM> can provide a sterile barrier and maintain the medical device <NUM> within a sterile environment. Advantageously, the RFID emitter <NUM> of the connector <NUM> can interrogate the RFID tag <NUM> of the medical device <NUM> to automatically verify information about the medical device or calibrate the console <NUM>. This can allow the sterile field to remain intact while the console <NUM> verifies information about the medical device <NUM>. As a result, if any changes to the equipment are required these can be carried out prior to breaching the sterile field.

In an embodiment, the RFID emitter <NUM> can provide an interrogation signal <NUM> to a specific medical device <NUM>, or towards a specific location relative to the RFID emitter <NUM>. In an embodiment, the RFID emitter <NUM> can broadcast an interrogation signal <NUM> to impinge on one or more medical devices, e.g. a first medical device130 and a second medical device 130A, proximate the RFID emitter <NUM>. In an embodiment, the RFID emitter <NUM> can provide an interrogation signal <NUM> before, during, or after a procedure.

Advantageously, the system <NUM> can provide an interrogation signal <NUM> to induce a response signal <NUM> from an RFID tag <NUM> disposed on a medical device <NUM>, e.g. stylet <NUM>, to determine specific information about the stylet <NUM> and can automatically calibrate the tracking system <NUM> for the specific medical device <NUM> being used, for example on connection of the stylet <NUM> with the connector <NUM>.

In an embodiment, a range of the RFID emitter <NUM> can be configured to trigger a response signal <NUM> when the medical device <NUM> is adjacent, or coupled to, the connector <NUM>. The RFID tag <NUM> can provide information, e.g. calibration or identification information, specific to the medical device <NUM> to the RFID emitter <NUM> and the console <NUM>. As such, the system <NUM> can automatically calibrate the console <NUM> to the specific medical device <NUM> attached thereto. This can save time and reduce the workload of clinicians by obviating manually entering such information to the console <NUM> either before, during or after a procedure. Further, errors in data entry, procedures, or in selecting incorrect calibration settings, or the like, are mitigated.

<FIG> shows a schematic view of the RFID enabled system <NUM> communicatively coupled to one or more networked devices. In an embodiment, the console <NUM> can include one or more processors <NUM> and one or more logic modules. In an embodiment, the console <NUM> can include a communications logic <NUM> configured to communicatively couple the console <NUM> with the medical device <NUM>, a network <NUM>, or a remote computing device <NUM>, e.g. an electronic health records (EHR) system, combinations thereof, or the like. The console <NUM> can be communicatively coupled either directly or indirectly with a network <NUM> or remote computing devices <NUM>. As used herein, the network <NUM> can be a centralized or decentralized network, intranet, local area network (LAN), internet, a "cloud" based network, or the like. As used herein the remote computing device <NUM> can be one or more computing devices, servers, mainframe, hospital network, electronic health record system, or the like. Advantageously, the network <NUM> or remote computing device <NUM> can provide information to the console <NUM> e.g. patient health records, or the like. The console <NUM> can then use this information together with information from the medical device <NUM> to display up to date information to the user or advise the user on a correct protocol. For example, previous access sites <NUM> can be provided from the patient records and the console <NUM> can display a location for a new access site, which can then be confirmed by information from the medical device <NUM>.

In an embodiment, the console <NUM> can include an RFID emitter logic <NUM> configured to send an interrogation signal <NUM> by way of the RFID emitter <NUM> and configured to receive and interpret a response signal <NUM> from the RFID tag <NUM>. In an embodiment, the console <NUM> can include a fiber optic tracking logic <NUM> configured to send and receive information to or from the fiber optic stylet <NUM>. As will be appreciated, the console <NUM> can include additional logic configured to be operatively coupled to additional structures, e.g. ultrasound logic configured to be operatively coupled to an ultrasound probe, a tip tracking logic configured to be operatively coupled to a tip tracking system, or the like. In an embodiment, the console <NUM> can include a data store <NUM> or similar non-transitory storage media configured to store information from the medical device <NUM>, console <NUM>, network <NUM>, or remote computing device <NUM>, combinations thereof, or the like.

In an embodiment, the RFID enabled system <NUM> can include one or more RFID tags <NUM> disposed on one or more medical devices <NUM> of different types. One or more RFID emitters <NUM> can be communicatively coupled with a console <NUM>, and configured to interrogate the one or more RFID tags <NUM> to determine information about the medical devices <NUM> that are present. Advantageously, since the passive RFID tag <NUM> does not require any power supply, active communication logic, associated structures, or the like, the RFID tag <NUM> can be very small in size and relatively cheap to produce. As such, the RFID tag <NUM> can be included in a variety of disposable or single-use medical devices or equipment, as described in more detail herein.

As noted herein, the fiber optic stylet <NUM> is an exemplary medical device <NUM> and not intended to be limiting. In an embodiment, the one or more medical devices <NUM> that each include an RFID tag <NUM> can also include: Indwelling devices such as catheters, peripherally inserted central catheters (PICC), central venous catheters (CVC), midline catheters, intravenous (IV) catheters, or the like. Procedural devices such as ultrasound probes, trackable medical devices, vascular access management systems, intravenous (IV) infusion systems, infusion pumps, inventory management systems, stylets, needles, needle guides, introducers, guidewires, surgical instruments, hemostats, scalpels, medical lines, tubing, surgical towels, disinfection tools, dressing change kits, swabs, IV fluid bags, or the like. Packaging of the medical devices, such as kit type, device type, or the like. Maintenance devices such as catheter caps, dressings, CHLORAPREP™swabs, SITE-SCRUB® IPA devices, or the like. Personnel identification equipment such as ID badges including personal details of the clinician, support staff, etc., patient bracelets including personal details of the patient, ID badges of visitors including personal details of the patients family, or the like. However, these examples are not intended to be limiting.

Information that can be stored on the RFID tag <NUM> and can be communicated to the RFID emitter <NUM> can include: Medical device identification such as make, model, serial number, batch number, kit number, or the like, of the medical device <NUM> or of a kit including one or more medical devices <NUM>. Medical device specification information such as size, type, dimensions, catheter configuration such as lumen (number, dimensions, etc.) or French size, calibration information, fiber optic calibration file, tracking profile, or the like. Personnel information such as information or signature info about the clinician, patient, support staff, or visitors, or the like. Analytics or compliance information such as the order of equipment to be used for a procedure, time stamp for when a procedure is started or when a medical device is used, duration of the procedure, time since start of various events (e.g. CHLORAPREP™ application time), time since completion of various events (e.g. CHLORAPREP™ dry time), time from last procedure, devices used during procedure, devices recovered after procedure, initiation of scanning, initiation of catheter placement, time access was obtained, time catheter introduced, duration of navigation stage, tip confirmed, site dressing applied, or the like. As will be appreciated, a time stamp can be recorded by the console <NUM> when a response signal <NUM> is first detected for given medical device <NUM> indicating a presence of the medical device proximate the RFID emitter <NUM>, or when a response signal <NUM> is no longer detected indicating an absence of the medical device proximate the RFID emitter <NUM>. Post-procedure and identification information such as detecting the presence and accounting for surgical tools prior to closure of a surgical site, detecting the presence and accounting for surgical towels prior to closure of a surgical site, catheter trim length, or the like. Automatic device update information such as start time, duration time, or an indication of replacement time for dressing replacements, catheter placement, site cleaning, site scrubbing, medical line (e.g. IV or catheter) flushing, infusion information, or the like. However, this is not intended to be limiting.

In an embodiment, information can be written to the RFID tag <NUM> and can be communicated to the RFID emitter <NUM> at a later date, or to a different RFID emitter 140A. In an embodiment, information that can be written to the RFID tag <NUM> can include medical device identification, medical device specification information, personnel information, analytics or compliance information, post-procedure and identification information, or automatic device update information, as described herein.

In an embodiment, analytics or compliance information can further include the start date/time, finish date/time, duration, etc. of a procedure or action, for example, when a catheter or dressing was placed, site cleaning, site scrubbing, flushing time, flushing duration, flushing count, the order of operations of a procedure based on one or more RFID tags <NUM>. Post procedural information can further include catheter trim length, catheter exit site marking, or the like. Identification information can further include information about the console(s) <NUM> being used with the medical device <NUM>, such as device information or settings of the console <NUM>.

In an embodiment, the console <NUM> can be communicatively coupled with additional consoles, computing devices, ultrasound systems, tip tracking systems, multi-modal tracking systems, infusion pumps, workstation, mobile device, handheld device, or the like being used with the medical device <NUM>, information about these additional devices can also be written to the RFID tag <NUM>. Identification information about these additional devices, computing platforms or software used by the additional devices can also be written to the RFID tag <NUM>.

Exemplary multi-modal tracking systems can use magnetic, electromagnetic, ultrasonic modalities, combinations thereof, or the like. Details of exemplary multi-modal tracking systems can be found in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

In an embodiment, the information written to the RFID tag <NUM> or encoded in a response signal <NUM> can be stored and analyzed by the console <NUM>. In an embodiment, the information described herein can be communicated by the console <NUM> either directly or indirectly with a remote location or remote computing device, for example a network <NUM>, or electronic medical records (EMR) <NUM>, intranet, internet, local area network (LAN), cloud-based network or the like. In an embodiment, the information described herein can be analyzed to assess compliance with regulation or operating procedures during a procedure, such as minimum cleaning times, dwell times not extended, etc. Further, the information can be used to track inventory of all devices present, devices used, devices disposed of, or devices retrieved during a procedure. This can ensure medical devices, surgical tools, surgical towels, disinfection tools, or the like, can be tracked and are not lost or miscounted. The information can be used for reporting of analytics of devices used, catheter trim length, amounts or counts of devices, fluids, or products used. This information can also be used for system optimization such as fiber optics calibrations, magnetic tracking profiles, success of outcomes, or the like, to improve future devices or systems, as described in more detail herein.

In an embodiment, the medical device <NUM> or console <NUM> can be communicatively coupled with additional medical device systems configured to detect and record additional information about a procedure. In an embodiment, this additional information can be written to the RFID tag <NUM> and can be read by the RFID emitter <NUM> to communicate the information to the console <NUM>.

In an embodiment, the additional information may include a length of time the medical device is in use, a number of times a needle enters the body, tissue identification, "backwalling," venous/arterial determination to determine correct or incorrect access thereto. The additional information can include needle stick location or depth mapping (e.g. by name, image, video recording, 3D mapping, navigation path, etc.), access site location or depth mapping, azygos placement/deviation, catheter occlusion identification using artificial intelligence (AI), machine learning, neural networks, image recognition or the like.

In an embodiment, one of the medical device <NUM> or the console <NUM> may be configured to request additional information from a user. The user can provide this additional information by way of a user interface disposed on one of the medical device <NUM> or the console <NUM>. As used herein a user interface can also include voice recognition or voice activation. In an embodiment, one of the medical device <NUM> or the console <NUM> can provide feedback to the user in the form of visual, audible, or tactile alerts. In an embodiment, the console <NUM> can be configured to record data from the medical device <NUM>, medical kit <NUM>, <NUM>, or from remote computing devices <NUM> in real time, can maintain a rolling archive, and/or can save the information about the procedure for future analysis, as described herein.

<FIG> shows an exemplary RFID tracking system ("system") <NUM> including one or more medical devices <NUM> provided as a kit <NUM>. As shown the medical devices <NUM> can include a catheter 230A, hemostat 230B, syringes 230C, tubing 230D, combinations thereof or the like. As described herein each of the medical devices <NUM> can include an RFID tag <NUM>. For example, the catheter 230A can include a catheter RFID tag 240A, the hemostat 230B can include a hemostat RFID tag 240B, etc. However, it will be appreciated that these medical devices and associated RFID tags are exemplary and other medical devices may also be used, as described herein. The medical devices <NUM> can be provided as a kit <NUM> such as a tray including one or more compartments each configured to receive one of the one or more medical devices <NUM>. In an embodiment, the kit <NUM> can include a flexible body or include one or more pockets, each pocket being configured to receive one of the one or more medical devices <NUM>.

In an embodiment, the system <NUM> can include one or more RFID emitters <NUM> communicatively coupled with a console <NUM> and each configured to provide an interrogation signal <NUM> that can impinge on the RFID tag(s) <NUM>. In an embodiment, the system <NUM> can further include a table <NUM>, cart, roll stand, or the like. In an embodiment, the table <NUM> can include an RFID emitter <NUM> disposed therein. The table <NUM> can include a surface configured to receive the kit <NUM>. More specifically, the table <NUM> can include an upper surface having one or more recesses or protrusions configured to align a lower surface of the kit <NUM> with the table <NUM>. As such, a compartment of the kit, including a medical device <NUM> disposed therein, can be aligned with an RFID emitter <NUM> disposed in the table <NUM>.

In an embodiment, the one or more RFID emitters <NUM> can be disposed in a flexible or rigid membrane that can be disposed below the tray kit <NUM>, between the kit <NUM> and the table <NUM> or similar supporting surface. In like manner, the membrane can be aligned with tray kit <NUM> to align a compartment including a medical device <NUM> with an RFID emitter <NUM>. In an embodiment, the one or more RFID emitters <NUM> can be disposed within the tray <NUM> itself and aligned with one or more compartments that includes a medical device <NUM>. In an embodiment, one of the kit <NUM>, the table <NUM>, or membrane that include an RFID emitter <NUM> that is communicatively coupled with the console <NUM>, and/or provide power to the kit <NUM>, table <NUM>, or membrane.

In an embodiment, the table <NUM> includes an RFID emitter <NUM> that provides an RFID interrogation signal <NUM> that can impinge on one or more of the RFID tags <NUM>, e.g. catheter RFID tag 240A, hemostat RFID tag 240B, and can trigger one or more response signals <NUM>, e.g. a catheter response signal 242A, a hemostat response signal 242B. In an embodiment, a first RFID emitter 220A can provide a first RFID interrogation 222A that can impinge on a first RFID tag <NUM>, e.g. a catheter RFID tag 240A, to induce a first (e.g. catheter) response signal 242A. A second RFID emitter 220B can provide a second RFID interrogation 222A that can impinge on a second RFID tag <NUM>, e.g. a hemostat RFID tag 240B, to induce a second (e.g. hemostat) response signal 242B.

In an embodiment, the RFID emitter <NUM> can provide a constant interrogation signal <NUM> that can trigger a response signal <NUM> when a medical device <NUM> including an RFID tag <NUM> is disposed proximate the RFID emitter <NUM>, e.g. when the tray kit <NUM> is placed on the surface of the table <NUM> and aligned with the RFID emitter <NUM>, or when the medical device <NUM> is returned to the compartment. In like manner, the system <NUM> can determine when a medical device <NUM> is being used by determining an absence of a response signal <NUM> when the medical device <NUM> is removed from the compartment.

In an embodiment, the system <NUM> can determine when the tray kit <NUM> is placed on the surface of the table, (e.g. pressure sensor, solenoid switch, light dependent capacitor, or the like) and can trigger the RFID emitter <NUM> to provide an interrogation signal <NUM> to impinge on the RFID tags <NUM>. In an embodiment, the kit <NUM> itself can include an RFID tag <NUM> and can included identification information about the kit <NUM> including information about the medical devices disposed therein, as described herein.

In an embodiment, the system <NUM> can determine information about the procedure based on which medical device(s) <NUM> or kits <NUM> that are detected by the RFID emitter(s) <NUM>. Further, the system <NUM> can determine information about the procedure based on the removal and replacement of the medical devices <NUM> from the kit <NUM>. For example, a catheter medical device 230A can be removed from the tray kit <NUM> and no longer provides a response signal <NUM> indicating to the console <NUM> that the catheter is being used and a time stamp can be applied to this event. When the catheter 230A has been finished with and replaced to the tray kit <NUM>, the system <NUM> can detect the presence of the catheter 230A based on the resumption of the response signal 242A. In an embodiment, the order with which each medical device <NUM> is used can be logged and analyzed by the system <NUM> to ensure compliance with regulations, standard operating procedures, or Information For Use ("IFU") protocols.

In an embodiment, the system <NUM> can use different modalities between the emitter <NUM> and the medical device <NUM>. Exemplary modalities can include electrical, magnetic, or optical.

In an embodiment, the emitters <NUM> can be electrical sensors configured to align with an electrical contact disposed on the medical device <NUM>. When the medical device <NUM> is disposed within the correct compartment, the compartment can be designed to align the medical device <NUM> with the electrical contact to complete an electrical circuit and determine the presence of the medical device <NUM> within the compartment or to transfer information between the medical device <NUM> and the tray <NUM> that is communicatively coupled with the console <NUM>. In an embodiment, each of the medical devices <NUM> can include a passive, permanent magnet, and the tray <NUM> or table <NUM> can be configured to detect the presence of the magnet when the medical device <NUM> when disposed within the compartment.

<FIG> shows an embodiment of an optically enabled medical device system <NUM> including a medical device tray kit <NUM> including one or more medical devices <NUM> disposed therein. In an embodiment, an optical camera <NUM> can image the kit <NUM>, e.g. from above. The camera <NUM> can be communicatively coupled with a console <NUM>, as described herein. The console <NUM> can include an image recognition logic <NUM> configured to determine the presence or absence of a medical device <NUM> from the kit <NUM> based on image recognition of the kit <NUM>. In an embodiment, the console <NUM> can use predetermined rule sets, artificial intelligence (AI), machine learning, neural networks, combinations thereof, or the like, to determine the presence or absence of the kit <NUM>, or a medical device <NUM> disposed therein. For example, the console <NUM> can compare a first image of the kit <NUM> with a second image of the kit <NUM> and determine if a medical device <NUM> has been removed, and is therefore being used, or if a medical device <NUM> has been replaced to the kit. Time stamps can be applied to these events and information about the procedure, order of use, start time, end time, duration of use, duration of each step, order of use, rate of use, combinations thereof, or the like, can be determined as described herein.

In an embodiment, a surface of the compartment can include a symbol, for example, an alpha-numerical symbol, barcode, QR-code, or the like, which can be optically detected by the camera <NUM>. When the medical device <NUM> is disposed within the compartment of the tray kit <NUM>, the symbol can be obscured, when the medical device <NUM> is removed from the tray kit <NUM>, indicating that it is being used, the symbol can be revealed and detected by the camera <NUM>. In an embodiment, the symbol can include information encoded therein and interpreted by the camera <NUM> and console <NUM>. As such, the system <NUM> can determine a start time, end time, duration, etc. for the medical device <NUM>, as described herein.

In an embodiment, the system <NUM> can include a camera <NUM> configured for detecting a bar code or QR code disposed on ID badges of a clinician, support staff, patient wrist bands, or visitor badges and can retrieve information about personnel. In an embodiment, the system <NUM> including the camera <NUM> can be configured for facial recognition of clinicians, support staff, patients, and visitors.

In an embodiment, the system <NUM> can further include an augmented reality ("AR") viewer <NUM>, such as AR goggles, AR heads up display ("HUD"), virtual reality ("VR") goggles, or the like. The AR viewer <NUM> can be communicatively coupled the console <NUM> and can provide a visual overlay <NUM> to the user indicating which medical device <NUM> to use, when to use, which order to use, how long to use, or where the medical device <NUM> should be returned to the kit <NUM>. The system <NUM> can determine the information to provide to the AR viewer <NUM> by detecting the location or usage of the medical device <NUM> by RFID modality, magnetic, or optical modalities, as described herein. Advantageously, the AR viewer <NUM> can prompt a clinician as to the procedural steps to follow, which medical device to use, and can ensure that regulations, standard operating procedures, or IFU protocols, are abided by. Further, information about the procedure, how the medical device is used, etc. can be stored an analyzed to help improve future systems.

In an embodiment, the medical device kits <NUM>, <NUM>, and associated medical devices <NUM>, <NUM> can configured for different procedures. Exemplary procedures can include: ultrasound imaging, ultrasound guided vascular access, needle tracking, probe tracking, fiber optic vessel mapping, needle path tracking, catheter tip location, catheter tip confirmation, multimodal tip location/confirmation, catheter placement, or the like.

For example, embodiments described herein can be used with a cleaning procedure for an ultrasound system capable of identifying anatomical targets and tracking medical instruments. An exemplary ultrasound kit <NUM> can be provided including one or more medical devices <NUM>, e.g. one or more ultrasound probes. The system <NUM> can be configured to record and recognize the procedural steps during a cleaning process of the ultrasound kit after use. Optionally, the ultrasound system can remain connected while cleaning or the probe can be wireless coupled to the ultrasound system console, e.g. console <NUM> while the cleaning procedure takes place. Exemplary sterilization systems can include high level disinfection systems, the TROPHON® system, or the like. Embodiments disclosed herein can determine a cleaning start time, e.g. when an ultrasound probe is removed from the tray kit, an end time, e.g. when an ultrasound probe is returned to the tray kit, a duration of the cleaning process, the steps involved, the order of the steps, or combinations thereof, to ensure correct protocols for the cleaning process are adhered to.

Embodiments of the system <NUM>, <NUM> can be capable of identifying procedural scenarios. For example, the system <NUM>, <NUM> can identify when procedures taking longer than expected and can identify problems. The system can monitor a procedure duration, a number of times a device is used, number of needle sticks, or the like, that can indicate when a procedure is encountering a problem. The system can request additional information from the user to supplement this information and can highlight these procedures for further review, targeting the source of the problem and allow from future improvements to the system.

<FIG> shows an embodiment of an RFID enabled ultrasound system ("ultrasound system") <NUM>. The ultrasound system <NUM> generally includes an ultrasound console <NUM> including one or more processors <NUM> and one or more logic modules ("logic"). In an embodiment, the ultrasound console <NUM> can include a communications logic <NUM>, an RFID emitter logic <NUM>, an ultrasound logic <NUM>, a data store <NUM>, a user interface (U. ) or display logic <NUM>, and an image recognition logic <NUM>. It will be appreciated that the ultrasound console <NUM> can include additional logic modules. In an embodiment, one or more of the communications logic <NUM>, the RFID emitter logic <NUM>, the ultrasound logic <NUM>, the user interface (U. ) or display logic <NUM>, or the image recognition logic <NUM> can use artificial intelligence (A. ), machine learning, neural networks, predetermined rule sets, combinations thereof, or the like.

The ultrasound console <NUM> can be communicatively coupled to an ultrasound probe <NUM> configured to emit and receive acoustic signals <NUM>. The acoustic signals <NUM> can be communicated with an ultrasound logic <NUM> configured to generate an ultrasound image of a portion of a patient. The ultrasound image can be static or dynamic and can be stored to the data store <NUM> or can be displayed on a user interface device <NUM> (e.g. display) or the like, coupled to the ultrasound console <NUM>. In an embodiment, the ultrasound console <NUM> can include an image recognition logic <NUM> coupled to the ultrasound logic <NUM> and/or the U. /Display logic <NUM> configured to determine information directly from the ultrasound image.

The ultrasound system <NUM> can further include one or more RFID emitter(s) <NUM> communicatively coupled with an RFID emitter logic <NUM>. In an embodiment, the RFID emitter <NUM> can be disposed on the ultrasound probe <NUM>. In an embodiment, the RFID emitter <NUM> can be a stand-alone device communicatively coupled with one of the ultrasound console <NUM> or the ultrasound probe <NUM>.

In an embodiment, the ultrasound console <NUM> can include a U. / display logic <NUM> that is communicatively coupled with one or more user interface devices <NUM>. Exemplary user interface devices can include a display, touch screen, microphone, voice recognition, keyboard, mouse, joystick, or similar devices configured to provide or receive information to/from a user. In an embodiment, the ultrasound console <NUM> can further include a communications logic <NUM> configured to communicatively couple the console <NUM> with one of a network <NUM>, a remote computing device <NUM>, additional medical device systems <NUM>, combinations thereof, or the like. In an embodiment, the ultrasound console <NUM> can be communicatively coupled either directly or indirectly with a network <NUM>, remote computing devices <NUM>, or additional medical systems <NUM>.

In an embodiment, the remote computing device <NUM> can be one or more computing devices, servers, mainframe, intranet, internet, hospital network, electronic health record system, combinations thereof, or the like. In an embodiment, the network <NUM> can be a centralized or decentralized network, intranet, local area network (LAN), internet, a "cloud" based network, or the like. In an embodiment, the one or more additional medical systems <NUM> can be a medical device system that can be used in conjunction with the ultrasound system <NUM> and can share information. Exemplary medical device systems can include tip location, tip confirmation, vessel mapping, fiber optic stylet mapping systems, needle tracking, probe tracking, needle path mapping, combinations thereof, or the like.

In an embodiment, the RFID emitter <NUM> can emit an interrogation signal <NUM>. The interrogation signal <NUM> can impinge on one or more RFID tags <NUM> to provide a response signal <NUM>. The response signal <NUM> can be received by the RFID emitter <NUM> can communicated to the RFID emitter logic <NUM>. The RFID tag(s) <NUM> can be disposed on medical device(s) <NUM>, medical device kit(s) <NUM>, or the like. The RFID emitter <NUM> can detect the presence of the RFID tag <NUM> that are within range of the RFID emitter <NUM> by the presence or absence of the response signal <NUM>. Further the RFID emitter <NUM> can read information stored on the RFID tag <NUM> or write information to the RFID tag <NUM>, as described herein.

Embodiments of the RFID enabled ultrasound system <NUM> can be used with a variety of medical procedures, each requiring various medical devices <NUM> to be used with ultrasound system <NUM>. Advantageously, the ultrasound system <NUM> can automatically detect and track which medical devices <NUM> are present, or being used by the clinician, based on the presence or absence of the response signal <NUM> detected by the one or more RFID emitters <NUM> communicatively coupled with the RFID emitter logic <NUM>. These medical devices <NUM> can be reusable medical devices or disposable medical devices (needles, stylets, surgical towels, surgical swabs, etc.) Advantageously, the ultrasound console <NUM> can record the number of disposable medical devices used in a procedure and account for the return of each medical device to ensure that each are accounted for and none are lost.

Further the ultrasound system <NUM> can determine information about the medical device <NUM>. For example, the medical device <NUM> can be a needle being used to access a vessel that is being imaged by the ultrasound probe <NUM>. The ultrasound system <NUM> can automatically detect the presence of needle <NUM> proximate the probe <NUM> by the presence of the response signal <NUM>, and determine information about the needle <NUM>, e.g. size, material composition, etc. that can be used by the console <NUM> to automatically modify the ultrasound settings for the specific needle being used. In an embodiment, the ultrasound system <NUM> can determine which procedure is being performed based on the response signal <NUM> received from a medical device kit <NUM>. The ultrasound console <NUM> can automatically modify the ultrasound settings of the ultrasound logic <NUM> to suit the procedure being carried out.

In an embodiment, the ultrasound system <NUM> can be used with a cleaning/sterilizing systems and procedures. Exemplary sterilization systems can include high level disinfection systems, the TROPHON® system, or the like. The RFID emitter <NUM> can determined the presence of a cleaning system based on the response signal <NUM> received from the RFID tag <NUM> associated therewith. The ultrasound system <NUM> can determine when the probe <NUM> is being cleaned based on the proximity of the probe <NUM> to the cleaning unit. The ultrasound system <NUM> can record a start time, finish time, or duration of the cleaning.

Optionally, the ultrasound probe <NUM> can remain communicatively coupled, e.g. wired or wirelessly, with the ultrasound console <NUM> while the cleaning is carried out. Embodiments disclosed herein can determine a cleaning start time, e.g. when the ultrasound probe <NUM> is disposed in the cleaning system bay, an end time, e.g. when the ultrasound probe <NUM> is removed from the cleaning system, a duration of the cleaning process, the steps involved, the order of the steps, or combinations thereof, to ensure correct protocols for the cleaning process are adhered to.

In an embodiment, the ultrasound system <NUM> can determine which clinicians, support staff, or patients are present for a procedure. For example, an RFID tag <NUM> can be disposed in an I. badge <NUM>, patient wrist band, or the like. The ultrasound system <NUM> can determine which clinicians, staff, or patients are present based on the number of response signals <NUM> or the information encoded within the response signal <NUM>. The ultrasound system <NUM> can record this information as part of the procedural information. Further, the ultrasound system <NUM> can query additional databases located on a network <NUM> or remote computing device <NUM>, e.g. EHR, to retrieve additional information about the clinician or patients present. For example, the RFID tag <NUM> can provide a patient ID number and/or a clinician ID number. The ultrasound console <NUM> can then query a hospital network to retrieve patient health records based on the patient ID number, to confirm identity, identify pre-existing conditions, or the like. The ultrasound console <NUM> can then provide information about the patient to the clinician before, during, or after the procedure.

In an embodiment, the ultrasound system <NUM> can be communicatively coupled with a camera <NUM>. The camera <NUM> can provide images to an image recognition logic <NUM> disposed on the ultrasound console <NUM>. The image recognition logic <NUM> can be configured to detect and interpret information from images provided by the camera <NUM>, for example bar codes or "QR" codes disposed on ID badges <NUM>, patient wrist bands, medical device kits <NUM>, or medical devices, as described herein. In an embodiment, the image recognition logic <NUM> can be configured for facial recognition, fingerprint recognition, iris recognition, or the like to determine the identity of clinicians, support staff, patients, or the like who are present for a procedure. In an embodiment the image recognition logic <NUM> can then use information detected in the image to query additional databases, e.g. EHR <NUM>, to retrieve additional information. In an embodiment, the image recognition logic <NUM> can determine the presence or absence of a medical device <NUM>, or the type of procedure carried out, based on an image of a medical device kit <NUM>. In an embodiment, the ultrasound console <NUM> can be communicatively coupled with an additional medical device system <NUM> such as an RFID enabled medical device kit <NUM> or an optically enabled medical device kit <NUM>, as described herein.

In an embodiment, the ultrasound console <NUM> can be configured to determine procedural scenarios based on the medical device(s) <NUM> used, the procedure order carried out, or a deviation from a procedure, in the order of medical device usage, or time taken. For example, the ultrasound console <NUM> can determine a "difficult stick" vessel-access procedure based on the length of time the access needle medical device <NUM> was used, the number of times the needle <NUM> entered the body, e.g. by tissue recognition needle information, image recondition by the camera <NUM>, or image recognition of the ultrasound display <NUM>, or the like. Further the console display <NUM> can provide a prompt to a clinician to request additional information about the procedure, problems encountered, number of failed attempts, etc..

In an embodiment, the ultrasound console <NUM> can determine a "mis-positioned" procedure, an accidental vein/artery access, or "backwalling" based on deviation in location or depth of the needle stick from a target location. As used herein, "backwalling" includes over penetration of a target vessel to penetrate a far wall of the vessel. For example, the ultrasound console <NUM> can retrieve information about the medical devices <NUM> or kits <NUM> being used to determine or confirm the procedure being carried out or identify the target vessel. The ultrasound system <NUM> can then update the system settings accordingly. Further, the image recognition logic <NUM> can review information from the ultrasound logic <NUM> or the U. / Display logic <NUM> to determine a location, orientation, or trajectory of the needle and a location of the target vessel and determine if the needle is aligned with, or has correctly accessed the target vessel, or not.

For example, the ultrasound console <NUM> can retrieve information from the medical device <NUM> or the medical device kit <NUM> that the procedure being carried out is a central venous catheter (CVC) placement. The ultrasound console <NUM> can automatically update the ultrasound system <NUM> settings for imaging and identifying the target vessel and/or vessel access medical devices. The image recognition logic <NUM> can review ultrasound information and determine if the needle is accessing the target vessel correctly, or is targeting an incorrect vessel such as an artery or an azygos vein. In an embodiment, the ultrasound console <NUM> can differentiate between arterial or venous target vessels using Doppler imaging. In an embodiment, the ultrasound console <NUM> can retrieve additional information from additional medical systems <NUM>, e.g. a tip location system, needle tracking system, or tissue differentiation needles (e.g. "smart" needles), to further improve the accuracy of needle tracking or trajectory.

The ultrasound console <NUM> can then provide a visual, audible, or tactile alert to the clinician if the access placement is incorrect.

Similarly, the ultrasound console <NUM> can identify medical device(s) <NUM> or medical device kits <NUM> that are used for arterial access or venous access and can modify the procedure, target vessels, or ultrasound system settings <NUM> to suit. In an embodiment, the image recognition logic <NUM> can review ultrasound information to automatically identify catheter occlusions for medical devices <NUM> (e.g. catheters) being imaged.

In an embodiment, the ultrasound console <NUM> can record and store information about the medical device <NUM> or the procedure carried out to the data store <NUM> and/or communicate the information with network(s) <NUM> or remote computing devices <NUM>. The ultrasound console <NUM> can then compare medical device equipment information or procedural information with predetermined equipment and procedure models to determine compliance with regulations, standard operating procedures, or IFU protocols. For example, the ultrasound console <NUM> can record excessive vessel attempts, duration of cleaning, the order of operations, the targeting of an incorrect vessels, vessel confirmation (smart needle), procedural step timing, or the like and can alert the clinician in real time if the equipment or procedural information is deviating from the predetermined standard operating procedures or the like. The ultrasound console <NUM> can alert the clinician using visual, audible, or tactile alerts. Compliance information can either be determined after the procedure has been completed, or can be notified in real-time as the procedure is carried out.

In an embodiment, the ultrasound system <NUM> can record and replay a subset of the procedural information, or can be configured to selectively record information about the procedure. In an embodiment, the ultrasound system <NUM> can be configured to include an on/off recording selection, rolling archive, or request input from the clinician as to whether to save information recorded about the procedure.

In an embodiment, the ultrasound console <NUM> can record a location of a needle access site for the patient. The access site information <NUM> can be recorded by the U. Display logic <NUM> from input from the clinician, image recognition information from the optical camera <NUM> and image recognition logic <NUM>, image recognition from ultrasound image information, the probe <NUM>, and the ultrasound logic <NUM>, information from the medical device and the RFID emitter logic <NUM>, or from additional medical device systems <NUM>, e.g. tip location systems, or the like. The access site information can be stored as reference points, co-ordinates, 3D renderings, video or images, or the like.

Access site information <NUM> can be stored locally on the data store <NUM> and or communicated to electronic health records (EHR) on a remote computing device <NUM>. The access site information <NUM> can then be automatically retrieved and presented to the clinician on the display <NUM> when the ultrasound system <NUM> determines that a medical device <NUM>, kit <NUM> or associated procedure requires the access site information. Advantageously, the ultrasound system <NUM> can indicate to the clinician where previous access sites were and identify different access sites to prevent the buildup of scar tissue for a patient.

In an embodiment, the ultrasound console <NUM> can record and identify procedural steps including a start of the procedure e.g. initiation of ultrasound scanning, initiation of placement, exit site management of tunneled catheters, catheter trim length, time or location of access obtained, time or location of catheter introduced, duration of navigation, total vasculature map (e.g. fiber optic stylet information, impedance/conductance information, ultrasound information), information from additional medical systems <NUM> (e.g. tip confirmation), site dressing used (e.g. RFID enable site dressing medical device <NUM>, as described herein), combinations thereof, or the like. The ultrasound console <NUM> can record the procedural information and optionally alert the clinician in real time if the equipment or procedural information is deviating from the predetermined standard operating procedures or the like. The ultrasound console <NUM> can alert the clinician using visual, audible, or tactile alerts.

In an embodiment, the ultrasound system <NUM> can determine a post-procedural model detailing information, events, timings, etc. of procedures to be carried out after the procedure is complete. The ultrasound system <NUM> can identify placement of a midline catheter procedure from the medical device(s) <NUM> or medical device kit(s) used, e.g. kit <NUM>. The ultrasound system <NUM> can record placement procedure information as described herein, identify when the procedure is complete and record information to the patient's EHR located on the remote computing device <NUM>, as described herein. Further, the ultrasound system <NUM> can identify a post-procedure model. The post procedure model can identify site dressing changes, flushing instances, flushing volumes, access timestamps, infusion info (volumes, fluids, etc.), catheter replacement, time of occlusions incurred, time of patency resolutions, combinations thereof, or the like.

For example, the ultrasound system <NUM> can identify, using RFID or optically enabled medical devices, which specific site dressing medical device <NUM> was used and when it was applied. The post-procedure model can identify when the site dressing <NUM> will need to be changed and if the change was carried out. Similarly, the post-procedure model can identify when the intravenous line was last flushed, which package of flushing solution was used and when the intravenous line will need to be flushed next.

Claim 1:
An RFID enabled medical device system, comprising:
a console;
an RFID tag (<NUM>) associated with a medical device; and
an RFID emitter (<NUM>) communicatively coupled with the console (<NUM>) configured to provide an interrogation signal (<NUM>) that can impinge on the RFID tag (<NUM>) to induce a response signal (<NUM>), the response signal configured to provide information to the console about the medical device,
wherein the medical device is a fiber optic stylet (<NUM>) configured to map a vascular pathway and the RFID tag (<NUM>) is disposed within a hub (<NUM>) disposed at a proximal end of the stylet (<NUM>), the information provided to the console includes calibration information,
wherein the RFID emitter (<NUM>) is configured to induce the response signal (<NUM>) when the hub (<NUM>) of the stylet (<NUM>) is coupled to a connector that is communicatively coupled with the console (<NUM>), wherein the connector provides fiber optic communication between the stylet and the console.