Systems and methods for ensuring drug administration and fluid delivery to a patient during clinical use

Abstract

To provide a system for ensuring liquid delivery to a patient in clinical use.SOLUTION: A system includes an electronic device including: a housing; an imaging sensor; a data transmission I / F for transmitting / receiving data for external electronic device; a data report accessory for providing information to a user; a microprocessor for managing the imaging sensor, the data transmission I / F, and the data report accessory; and a program for acquiring and processing an image of an infusion set for delivering a treatment medicine to the patient from a liquid container through a blood vessel access device. The program verifies that the infusion set is correctly connected by identifying a connection point between the parts of the infusion set on the image of the infusion set captured by the imaging sensor, processes part of the image including the connection point, and determines wither or not the connection is sufficient.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to systems and methods for identifying, verifying, and documenting the delivery of drugs and fluids to patients, and more particularly, to systems and methods that operate without using the hands using wearable electronic devices.

Background Art

[0002] Blood sampling is a common healthcare procedure that involves extracting at least one drop of blood from a patient. Blood samples are generally collected from inpatients, home treatment patients, and emergency department patients by finger stick, heel stick, or venipuncture. After being collected, the blood sample can be analyzed to obtain medically useful information including chemical composition, hematology, coagulation, etc.

[0003] Similarly, fluid delivery to patients is achieved using various vascular access devices including syringes, auto-injectors, pen injectors, catheters, and infusion devices. In a medical setting, a clinician or technician performs an injection by inserting a needle into a patient's vein. Therapeutic drugs are provided to the patient directly or passively through the needle. For example, a medical technician can inject a fluid by pushing a piston rod and plunger through a syringe barrel and discharge the fluid therefrom. Alternatively, the therapeutic drug can be provided passively from an IV bag through an infusion set.

[0004] Before performing a liquid sampling or liquid delivery procedure, the clinician or technician is responsible for obtaining any necessary medical instruments and devices. The clinician or technician may also be responsible for performing an initial examination of the patient by checking the body temperature, heart rate, or respiration. The clinician or technician can review the entries in the patient's chart or other printed instructions to ensure that these initial steps are carried out correctly and that any necessary equipment is available. Alternatively, the technician can scan the barcode or identification display on the equipment obtained to record that some items are being used. The medical professional then obtains a liquid sample or performs a liquid injection. After the sample has been collected or the liquid has been injected, the clinician or technician may need to appropriately document that the procedure has been completed. For example, the clinician or technician can write an entry in the patient's chart that includes the time the procedure was completed, a description of the procedure performed, and a record of any abnormal or unexpected events. Further, when obtaining a liquid sample, the medical professional can be responsible for closing or sealing the sample collected with an anti-tampering seal so that the sample is not compromised prior to testing. The technician or clinician can be responsible for verifying the seal, for example, by signing their name or initials on the fragile label covering the seal.

[0005] At many healthcare facilities, these preparation, verification, and documentation tasks are performed manually by clinicians or technicians while a medical procedure is being performed or after the procedure has been completed. For example, a clinician or technician can be responsible for manually labeling each collected fluid sample with patient-identifying information before transferring the sample for testing. Similarly, a clinician or technician can be responsible for manually recording in the patient's chart the type of fluid that was infused into the patient. Medical professionals can also be expected to record the date and time the procedure was performed. In some situations, clinicians or technicians are equipped with electronic recording means such as a computer, laptop computer, tablet PC, smartphone, or similar easily portable computing device. However, the technician or clinician is still responsible for manually entering information into the electronic device. Alternatively, a data entry technician can be responsible for electronically entering information regarding the procedure performed based on the records taken by the clinician or technician. Additionally, many large healthcare facilities utilize an electronic patient database for electronically storing patient information. However, even such an electronic database still requires manual data entry by a clinician or technician, or subsequent data entry based on contemporaneous records taken by a clinician or technician.

[0006] Numerous manual steps required before, during, and after fluid sampling or fluid delivery procedures create opportunities for user error. User error can result in incomplete or incorrect procedures being performed or patient data being lost. For example, a clinician or technician may inject an incorrect volume, incorrect fluid type or concentration, or may not obtain a sufficient volume of fluid sample for the test being performed. A healthcare clinician or technician may also forget to correctly record that a fluid sample was obtained or under what conditions the sample was obtained. Additionally, a clinician or technician may fail to correctly record which patient provided a particular fluid sample. These problems can harm the patient or, at the very least, may require some fluid sampling procedures to be repeated. Accordingly, there is a need for a system for delivering fluid to a patient and a system for obtaining test specimens that assist a clinician or technician in performing and recording a medical procedure. The system should be configured to prevent errors commonly occurring during such procedures and should provide visual or audible warnings when an error occurs. The system should also be automatically integrated with existing patient data systems so that information regarding the type of procedure being performed is readily accessible to the clinician or technician. Further, confirmation that the procedure has been performed and related information regarding the procedure can be automatically and directly provided to the patient's medical record to ensure that patient data has not been lost. The systems and methods described below are provided to address some or all of these problems. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] The systems and methods provided herein reduce the risk of infusion and delivery errors of medications and improve the clinical workflow for identifying, verifying, and recording the fluid delivery of medications and fluids to patients. These identification, verification, and documentation operations are achieved in real time and during clinical use.

[0008] According to an embodiment of the invention, the system includes a wearable electronic device configured to be worn by a user. The wearable electronic device includes a housing, at least one imaging sensor associated with the housing, a data transmission interface for sending data to or receiving data from an external electronic device, and a data reporting accessory for providing data to the user. The wearable electronic device also includes a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory, and a program for acquiring and processing images from the at least one imaging sensor. The system further includes a fluid delivery device for passively or actively delivering a therapeutic agent to a patient, and one or more identification tags attached to or formed integrally with the fluid delivery device. The program processes the images captured by the at least one imaging sensor to identify the one or more identification tags and obtain fluid delivery device information from the one or more identification tags.

[0009] In some configurations, the program verifies the completion of the fluid delivery procedure by processing the images obtained by the at least one imaging sensor. The program can report the fluid delivery device information and the verification of the completion of the fluid delivery procedure to the user via the data reporting accessory or transmit the information and verification to an external electronic device via the data transmission interface.

[0010] The program can automatically acquire and process images to obtain information from the one or more identification tags and verify the completion of the fluid delivery procedure. In some configurations, the data reporting accessory provides information to the user without using hands.

[0011] The wearable electronic device can be a head-mounted computer, and the data reporting accessory can be a projection prism configured to project a virtual layer onto the user's field of view. The virtual layer can include a user interface including a patient information section, a dosing confirmation section, an identification tag confirmation section, a liquid delivery device volume indicator, or any combination thereof. The at least one imaging sensor can be a digital camera or a digital video camera.

[0012] Optionally, the program can track the movement of the movable part of the liquid delivery device from the initial position to the final position by processing a series of images of the liquid delivery device acquired by the at least one imaging sensor and confirm the completion of the liquid delivery procedure. The movable part of the liquid delivery device can be a plunger or a piston rod movable through the body of the liquid delivery device. The movable part can be coated with a substance that improves the visibility of the movable part in a series of images captured by the at least one imaging sensor, and the tracking of the movement of the movable part can be improved.

[0013] In some configurations, the liquid delivery device can include one or more sensors configured to determine when a part of the liquid delivery device is inserted into the patient or when liquid is discharged from the liquid delivery device. The one or more sensors are connected directly or indirectly to the wearable electronic device, and the data collected by the one or more sensors can be provided to the user via the data reporting accessory or transmitted to an external electronic device via a data transmission interface.

[0014] The wearable electronic device can further include a data storage medium for storing programs, liquid delivery device information, confirmation of completion of liquid delivery procedures, or images captured by at least one imaging sensor. The wearable electronic device can also include a peripheral data input device that allows a user to manually input data into the wearable electronic device. The peripheral data input device can be a motion sensor, gyroscope, pressure sensor, accelerometer, touch pad, touch screen, or any combination thereof. The wearable electronic device can further include a power source within the housing of the wearable electronic device. The data transmission interface can be configured to send data to and receive data from a patient data system.

[0015] Optionally, the information received from the patient data system includes information regarding the procedure to be performed, information regarding the liquid delivery device required for the procedure, or information regarding the patient. The information transmitted to an external electronic device can include confirmation of completion of the liquid delivery procedure, the time and date of the procedure, the liquid infusion volume of the procedure, the quality or type of liquid infused during the procedure, or any combination thereof. The liquid delivery device can be one or more of a prefilled syringe, pen-type syringe, autoinjector, infusion set, catheter, vascular access device, or any combination thereof.

[0016] One or more identification tags can include two-dimensional barcodes, three-dimensional barcodes, near-field communication devices, or labels having text readable by an optical character recognition algorithm. The program identifies one or more identification tags within the captured image by processing the image to identify the position of the position markers on the liquid delivery device and then identifying the position of the one or more identification tags based on the position of the position markers on the image. The system also includes a patient identification device that includes or is associated with identification information regarding the patient, and the patient identification device is readable by at least one imaging sensor of the wearable electronic device.

[0017] According to a further embodiment of the present invention, the system includes a wearable electronic device configured to be worn by a user. The wearable electronic device includes a housing, at least one sensor associated with the housing, a data transmission interface for sending data to or receiving data from an external electronic device, and a data reporting accessory for providing information to the user. The wearable electronic device also includes a microprocessor for managing at least one sensor, the data transmission interface, and the data reporting accessory, and a program for acquiring and processing data acquired by the at least one sensor. The system further includes a fluid delivery device for passively or actively delivering a therapeutic agent to a patient, one or more identification tags attached to or integrally formed with the fluid delivery device, and a patient identification device including or associated with identification information regarding the patient and readable by at least one sensor.

[0018] In some configurations, the program manages acquiring information from one or more identification tags and the patient identification device. The program can also determine whether the fluid delivery device is sufficient for a fluid delivery procedure based on information obtained from the one or more identification tags and the patient identification device.

[0019] The data reporting accessory can provide a warning to the user if the fluid delivery device is insufficient for a fluid delivery procedure. In some configurations, the patient identification device includes identifying the location of the circuit to determine the location of the patient.

[0020] According to another embodiment of the present invention, the system includes a wearable electronic device configured to be worn by a user. The wearable electronic device includes a housing, at least one imaging sensor enclosed within or associated with the housing, a data transmission interface for sending data to or receiving data from an external electronic device, and a data reporting accessory for providing information to the user. The wearable electronic device also includes a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory, and a program for acquiring and processing images obtained by the at least one imaging sensor. The system further includes an infusion set for delivering one or more therapeutic agents from a fluid container to a patient via a vascular access device. The program measures the flow rate of the fluid being discharged from the fluid container and measures the fluid flow velocity from the fluid container by processing a series of images captured by the at least one imaging sensor.

[0021] The program can verify whether the infusion set is correctly connected by identifying connection points between portions of the infusion set on an image of the infusion set captured by the at least one imaging sensor, and processes the portion of the image including the connection points to determine whether a sufficient connection exists. The data reporting accessory can also warn the user when the program determines that the connection is insufficient.

[0022] According to yet a further embodiment of the present invention, a method for verifying fluid delivery to a patient during clinical use includes operating a fluid delivery device that discharges fluid therefrom by advancing a movable part of the fluid delivery device through the body of the fluid delivery device, and obtaining a series of images of the fluid delivery device with a wearable electronic device having at least one imaging sensor when the movable part is advanced through the body. The method also includes processing the series of images for real-time determination when the movable part of the fluid delivery device has been advanced to its final position of use, and notifying the user wearing the wearable electronic device that fluid delivery has been completed when an image indicating that the movable part of the fluid delivery device is at its final position of use has been obtained. The processing step is automatically performed without any operation by the user.

[0023] The step of processing the series of images can be performed using a computer of the wearable electronic device, a virtual computer, a dedicated external electronic device connected to the wearable electronic device by wire or wirelessly, or an external computer connected to the wearable electronic device via a data transmission interface. The method also includes processing at least one of the series of images to identify and extract information regarding the fluid delivery device from an identification tag attached to or formed integrally with the fluid delivery device. In some configurations, the fluid delivery device is a syringe and the movable part is a plunger that is advanced through the body of the syringe from an initial position at the proximal end of the body to a final position of use at the distal end of the body.

[0024] These other features and characteristics of the present invention, as well as the operational methods and functions of the related elements and components of the structure, and the economic efficiency of manufacturing, will become more apparent upon consideration of the following description and the appended claims, which form a part of this specification, with reference to the accompanying drawings, in which like reference numerals designate corresponding parts in the various figures. It should be clearly understood, however, that the drawings are for illustrative and explanatory purposes only and are not intended to define the limitations of the present invention. As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

Brief Description of the Drawings

[0025]

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DETAILED DESCRIPTION OF THE INVENTION

[0026] The following description is provided so that those skilled in the art can make and use the foregoing embodiments contemplated for carrying out the present invention. However, various modifications, equivalent forms, variations, and alternative forms will still be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalent forms, and alternative forms are intended to be included within the spirit and scope of the present invention. However, it should be understood that the present invention may take various alternative variations and sequences of steps, unless explicitly specified to the contrary. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting. For ease of understanding the present invention, the accompanying drawings and description show its preferred embodiments, from which the present invention, various embodiments of its structure, configurations, and operating methods, as well as many advantages, can be understood and recognized.

[0027] The present invention is directed to systems and methods for the identification, verification, and documentation of the use of hands in various medical procedures during clinical use, including invasive procedures that require treatment guidance. Exemplary procedures include, but are not limited to, the delivery of drugs and fluids, specimen or sample collection, and / or vascular access procedures. The system improves upon existing patient data systems by collecting and recording data without requiring affirmative action by a user or operator, hereinafter referred to as a healthcare worker. More specifically, the system enables the necessary identification, verification, and documentation operations to be performed without the user or operator, hereinafter referred to as a healthcare worker, having to manually record information or operate a data input device, such as a scanner, camera, keyboard, or touch screen, which is currently required in existing patient data systems. The system improves the clinical workflow and data entry integrity by reducing the likelihood of technician error. Further, the system reduces the risk of infection to patients and healthcare workers. In particular, since the healthcare worker does not have to touch or operate the data input device, the risk of contamination of the input device is reduced.

[0028] The system can be integrated with existing equipment, including single-use medical devices that have already been used, as well as existing patient databases and patient monitoring software. Thus, the system does not require additional equipment or capital infrastructure improvements on the part of the healthcare facility. Similarly, the system can be easily integrated with the procedures and practices of a particular healthcare facility.

[0029] Referring to FIG. 1, there is shown a system 10a for ensuring and verifying fluid delivery to patients who do not use their hands during clinical use. System 10a effectively obtains data regarding the fluid delivery to be performed from an external source such as a patient data system, records that a fluid treatment has been performed, and sends confirmation of that treatment to the external source. System 10a is provided to reduce the risk of medication errors at the time of administration by providing real-time patient information, warnings, drug identification, and administration confirmation without using hands.

[0030] System 10a includes a wearable electronic device. In a preferred and non-limiting embodiment, the wearable electronic device is a wearable computer with an augmented reality display, hereinafter referred to as "wearable electronic device 18". An exemplary wearable electronic device 18 can be a head-mounted device such as glasses incorporating Google Glass technology created by Google Corp., Mountain View, CA. Google Glass technology is not currently commercially available, but if Google Glass or a similar product were to be commercially available, one of ordinary skill in the art would consider it to be easily implemented in the system of the present invention. Alternatively, the wearable electronic device 18 can be a head-mounted face shield that also incorporates Google Glass technology. In a further embodiment, the wearable electronic device 18 can be a device attached to the wrist that also incorporates Google Glass technology. The wearable electronic device can also have other shapes and configurations based on the specific fluid delivery procedure to be performed. For example, the wearable electronic device can be a button or pin attached to a healthcare worker's clothing, a watch worn on the wrist, a necklace, a pendant, or any other type of item that is not eye-catching and can be easily carried.

[0031] The wearable electronic device 18 can include a hat, helmet, face shield, wristband, or frame 20 (e.g., one eyeglass frame) having a display portion 16, such as a projection prism, face shield, or a display worn on the wrist that extends into the field of view of the healthcare provider. The display portion 16 can be positioned close to the wearer's eyes, such as in the case of a projection prism. The display portion 16 is configured to present a virtual layer, such as the projected layer of FIG. 2, within the wearer's field of view equivalent to a larger screen viewed from a greater distance. For example, in an example where the display portion 16 is a projection prism, the projection prism can be positioned less than 1 inch (2.54 cm) from the wearer's eyes and presents a viewable screen that appears similar to a 25-inch (63.5 cm) screen viewed from 8 feet (2.44 m) away. The augmented reality display projects a virtual projection or layer 22 that includes a portion of the wearer's field of view. The entire field of view of the healthcare provider is not blocked by the virtual layer 22. The healthcare provider can still "see" the real layer 24 beyond or adjacent to the virtual layer 22.

[0032] In other embodiments, the data display portion 16 of the wearable electronic device 18 can be a visual display, such as a standard monitor for a computer or smartphone. Standard monitors include liquid crystal displays (LCDs) and light emitting diode (LED) displays. The monitor can be formed integrally with the wearable electronic device or can be an external screen or device viewable by the technician. The wearable electronic device 18 can also communicate treatment and patient information to the technician via other means of communication, including but not limited to, audio alerts or tactile confirmations. For example, the wearable electronic device 18 can emit a beep or vibrate to notify the technician that a problem has been identified.

[0033] The attachable electronic device 18 further includes a computer housing 26 or a casing attached to the frame 20. The housing 26 can have any dimensions necessary to hold the necessary associated electronic devices. The associated electronic devices within the computer housing 26 can include data collection devices and sensors, data transmission and communication circuits, data processing circuits, as well as data display and warning devices and circuits. The computer housing 26 is desirably small and lightweight enough not to cause a substantial hindrance to the wearer or operator when the operator performs normal functions and operations.

[0034] The data collection device can include various sensors and recording devices to obtain information regarding the medical procedures being performed. For example, the data collection function can include one or more image capture devices 12, such as a digital camera, for image or video capture. In some embodiments, the image capture device 12 can be adapted to provide two-dimensional (2D) images (s) (static or moving), or three-dimensional anatomical scan geometries. The image or video camera typically consists of a charge-coupled device (CCD) or complementary metal-oxide semiconductor (CMOS) imaging sensor, a lens, a multi-functional video control / digital signal processing (DSP) chip, and a set of discrete components (e.g., capacitors, resistors, and connectors). The video control / DSP chip can be formed integrally with the camera 12. Alternatively, image processing can be performed either on a wearable electronic device or, further, on an external controller or computer. The lens can include a focal range useful for imaging as described herein, or the video camera can include an autofocus function. Similarly, the lens can be provided with a zoom function. The video control components on the chip perform some image acquisition tasks, while the DSP components on the same chip perform data processing algorithms, such as noise reduction and simple forms of data compression and encryption. The digital output from the video control / DSP chip can be in parallel or serial form, depending on the specific chip design and input configuration at the next data processing or interface stage. The system can also include a microphone for auditory (e.g., voice command) input, a touch mechanism or trackpad for tactile input, accelerometers, gyroscopes, and the like.

[0035] Electronic communication and data transmission devices, as well as electronic circuits, can include a data transmission interface 14 for sending and receiving data to and from an external source such as an external electronic device. The external device can be a data storage device, an external computer, a local computer network consisting of several computing devices, or the Internet. For convenience, these external electronic devices shall be collectively referred to as the cloud 15. The data transmission interface actually creates a personal area network (PAN) including a wearable electronic device 18, a data transmitter, and an external receiver attached to the external source. The PAN is a computer network used for communication (e.g., data transmission) among computer devices including a telephone and a personal digital assistant (PDA) in the vicinity of the engineer's body. The PAN can be used for communication within the personal device itself (intra-personal communication) or for connecting to a higher-level network and the Internet (uplink). A wireless personal area network (WPAN) is enabled using wireless network technologies such as Bluetooth®, WiFi, Z-Wave, and ZigBee. The WiFi (e.g., IEEE802.11a, b, g, n) networking protocol can be used, which is advantageous as it has a larger transmission range than Bluetooth®, but as a result, it also has a larger power consumption. Suitable external sources for receiving the data transmitted from the device and optionally processing the data include a computer, a tablet PC, or a smartphone, and / or an external hard drive, or other devices for backing up the stored data.

[0036] In some embodiments, data transmission interface 14 is integrated with an existing patient data system or database. A mobile patient data acquisition and recording system integrated for use with a handheld electronic device, such as a smartphone, may also be integrated with data transmission interface 14. These systems allow a user to remotely update patient data using the handheld electronic device. The updated information is transferred to a data storage location where it can be accessed for future use. Commercially available software platforms can be used to coordinate the recording of patient data and can include features to facilitate easy access to such data at the time of caregiving. As a result of this integration with such existing database software platforms, system 10a of the present invention can automatically update patient data stored in a patient data system or database when a procedure is being performed. However, unlike existing systems, this system 10a automatically updates patient data without requiring direct input from a healthcare technician. Thus, system 10a is fully and automatically integrated into the patient data system. In contrast, previously, data was manually entered by a healthcare technician after a procedure was performed.

[0037] In some embodiments, the wearable electronic device 18 can also include a data storage device 21 formed integrally with the computer housing 26. In one non-limiting embodiment, the storage device 21 is a digital recording device such as a disk drive, which records data on a storage medium. In another embodiment, the storage medium is flash memory. The storage medium can be any type of non-volatile memory, such as a magnetic data storage medium like a hard disk drive or magnetic tape, or flash-based memory. Flash memory is a non-volatile computer storage chip that uses NAND or NOR type memory found in MicroSD cards, USB flash drives, or solid state drives. File systems optimized for flash memory (solid state media) include the Embedded Transaction File System (ETFS), exFat, and FFS2 systems. The storage medium can be random access memory (RAM) or read-only memory (ROM). The memory can be removable from the device or permanently attached within the housing and can be transferable to an external device via the data transmission interface 14.

[0038] In one embodiment, the wearable electronic device 18 further includes one or more power sources, such as a battery 23 contained within a computer housing 26. The battery 23 comprises one or more electrochemical cells that convert stored chemical energy into electrical energy. A non-limiting example of a useful battery is a lithium-ion battery. Lithium-ion batteries are rechargeable batteries commonly used in electronic devices. The capacity of the lithium-ion battery is preferably sufficient to power the wearable electronic device over the course of a full day or more. However, in some cases where the device is not operated continuously, a smaller capacity battery may be more appropriate to reduce device size and weight. Other types of batteries suitable for use in the device include nickel-cadmium (NiCd) and nickel-metal hydride (NiMH) batteries. The battery 23 is preferably rechargeable, in which case the device further includes a battery recharge port.

[0039] The electronic devices and electronic circuits contained within the housing 26 of the wearable electronic device 18 are controlled by one or more controllers, such as a microprocessor. A microprocessor is a chip that includes one or more integrated circuits that receive data and process the data according to instructions stored in the chip's memory. The microprocessor typically manages data collection from various sensors and the digital camera 12, along with other functions, directs the storage of data by the data storage system, and allocates system resources among the electronic components to reduce power consumption and reduce the need for redundant electronic systems. The microprocessor can include software for controlling various data collections and software for processing the collected data. Similarly, the microprocessor can include software for displaying the collected data and for interacting with the technician. Alternatively, the controller can facilitate the transfer of data and instructions between the wearable electronic device and an external processing device, such as an external computer or workstation.

[0040] Continuing to refer to FIG. 1, the system 10a includes a fluid delivery device 28, such as a prefilled syringe, a pen-type syringe, an auto-injector, an infusion set, a catheter, or any combination thereof. The wearable electronic device 18 is configured to identify and recognize the fluid delivery device 28. To facilitate identification and recognition, the fluid delivery device 28 can include an identification tag 30 formed integrally with or attached to it. The identification tag 30 can be a standard two-dimensional barcode, a three-dimensional barcode (e.g., a quick read (QR) code, etc.), as well as various manufacturer-specific encoded computer-readable tags and labels known in the art. The identification tag 30 can be formed integrally on or within the fluid delivery device 28. Alternatively, the identification tag 30 can be printed on the fluid delivery device 28 or on a label adhered to the fluid delivery device 28. In any case, the wearable electronic device 18 is configured to identify the identification tag 30 and extract information therefrom. The identification tag 30 can provide information regarding the fluid delivery device 28 and the fluid contained therein, including drug type, total fluid volume, manufacturer, needle size, fluid expiration date, and the like.

[0041] In some embodiments, the wearable electronic device 18 can include an image processing function for identifying and extracting data from an image of the identification tag 30 captured by the digital camera 12. The image processing function can be configured to identify various position markers on the fluid delivery device 28. The position markers may point to the identification tag 30 and can trigger the wearable electronic device 18 to start capturing an image of the identification tag 30. When an appropriate image is captured, the image processing function evaluates the image and extracts information from the identification tag 30. The image processing function can also include a time delay, such as 3 seconds, which means that the wearable electronic device 18 does not start attempting to process or read the image of the identification tag 30 until the position marker has been within the field of view for at least 3 seconds. The time delay function conserves computing power by limiting when the image processing occurs. In particular, only identification tags 30 that are of sufficient interest for the technician to view for a few seconds are scanned and information is extracted therefrom. In some embodiments, identification tags 30 that are not within the technician's field of view for at least 3 seconds are assumed to be unimportant and are thus not read.

[0042] Alternatively, the identification tag 30 can be a standard printed text containing the name and quantity of a drug or therapeutic agent, and a standard medical label. The wearable electronic device 18 can be configured to capture an image of the label and read the information contained therein. For example, the system 10a can include an optical character recognition algorithm configured to extract data from printed text, such as a printed medical label. Thus, the system can be used with existing fluid delivery devices 28 and syringes, and there may be no need to add additional tags or electronic positioning devices.

[0043] In another alternative embodiment, the identification tag 30 can be a near field communication (NFC) device, such as a radio frequency identification (RFID) tag or an electronic device, that can project a readable signal that can be identified and read by a scanner, transmitter, or antenna associated with the wearable electronic device 18. Including an NFC device, or an RFID tag, simplifies the data extraction process. In particular, no image processing is required to extract information from the NFC device or RFID tag.

[0044] In some embodiments, the identification tag 30 can be printed on or attached to the liquid delivery device 28 using a selectively visible type of ink that can only be read at a specific time, such as immediately before the liquid delivery occurs. After the liquid delivery is completed, another or modified identification tag 30 becomes visible and can indicate the end of use or the completion of the infusion.

[0045] The system 10a can also include means for identifying when the liquid delivery occurred, or optionally, means for estimating the liquid delivery volume. The system 10a can monitor the liquid delivery by tracking the movement of an actuating mechanism or liquid discharge mechanism, such as the plunger 32 or the piston rod 34, during the liquid delivery procedure. In some further embodiments, the identification tag 30 can be used to estimate the position of the plunger 32 or the piston rod 34. For example, image processing software can also record the initial position of the plunger 32 or the piston rod 34 relative to the position of the identification tag 30. When the plunger 32 or the piston rod 34 moves relative to the position of the identification tag 30, the image processing software determines that the infusion has started. When the plunger 32 or the piston rod 34 has advanced a predetermined distance from the identification tag 30, it can be assumed that the infusion is complete.

[0046] System 10a can also be configured to automatically identify the position of the plunger 32 or the piston rod 34 relative to other markers on the fluid delivery device 28. In some embodiments, the marking can also be a graduated line or indication on the syringe barrel. In that case, the movement of the plunger 32 or the piston rod 34 relative to the marking can determine not only the start and administration, but also the amount of fluid delivered. In further embodiments, the plunger 32 can include a coating or indicator that is easily identifiable on an image captured by the digital camera 12. Alternatively, the coating can also be made easily detectable by another scanning element, such as an ultraviolet or infrared detector. Such a device or scanner can also be associated with the wearable electronic device 18. Improving the visibility of the plunger 32 can improve the recognition by the image processing function and enable a more accurate measurement of the position of the plunger 32, thereby improving the estimation of the quantity.

[0047] In some embodiments, additional electronic or mechanical sensors can be associated with the fluid delivery device 28 to provide additional evidence or confirmation of fluid delivery. For example, the sensor can be placed near the injection needle 36 of the fluid delivery device 28. The sensor can record when the needle 36 is correctly inserted into the patient and also ensure that the fluid passes through the needle 36 and is discharged to the patient. The data collected by the sensor can be transmitted to the wearable electronic device 18 by a wireless transmitter, such as Bluetooth (registered trademark) that is adapted for short-range communication. Including the sensor directly on the fluid delivery device 28 increases the complexity of the fluid delivery device 28 and the associated electronic devices, but is advantageous as it provides additional confirmation that fluid delivery to the patient has actually occurred.

[0048] In addition to being used to locate and read the identification tag 30 and to provide confirmation of the end of administration, the image capture function of the wearable electronic device 18 can also be utilized to store and record fluid delivery procedures. For example, images of the injection process (such as inserting a needle into a patient's vein), an empty syringe, and a discarded syringe can be obtained and included in the patient's electronic record. Each of these images can be incorporated with a time stamp. The time stamp can be used to update the patient's medical record using the exact time at which the procedure was performed.

[0049] The wearable electronic device 18 is configured to present the data collected by the system's image capture and other functions to the technician in an easy-to-use and readily accessible manner. It is desirable for the data to be presented to the technician directly within the technician's field of view in a clear and concise manner via the display portion 16 of the wearable electronic device 18.

[0050] Exemplary view 100, which is seen by a technician wearing the wearable electronic device 18 and includes both the virtual layer 22 and the reality layer 24, is shown in FIG. 2. As shown in FIG. 2, the virtual layer 22 includes a user interface 110. The user interface 110 can include a heading bar 112 or title having information about the patient, such as the patient's name and the patient's identification number. The heading bar 112 or title can also include a description of the medical procedure being performed, or information about the type of infusion or the fluid delivery device required. The user interface 110 can also include a syringe volume indicator icon 114 indicating the estimated fluid remaining in the syringe. The icon 114 allows the operator to easily determine when all of the fluid has been injected into the patient and thus serves as an end-of-dose indicator. Finally, the user interface 110 can also display an identification tag confirmation icon 116. The icon 116 can also indicate when the identification tag 30 has been identified on an image obtained by the image capture function. Further, the identification tag confirmation icon 116 can indicate confirmation that the identification tag 30 is correct, such as when the fluid delivery device 28 required for the particular procedure being performed has been recognized. If the position of the identification tag 30 cannot be determined, or if an incorrect identification tag 30 is found, the icon 116 can display a warning and indicate to the technician that the injection should not be performed.

[0051] As described above, the virtual layer 22 does not block the operator's overall view 100. Thus, the operator can still see the reality layer 24 even while the user interface 110 is visible. Thus, the technician can see any warnings while preparing to perform the procedure. As a result, the likelihood that the technician will miss a warning because they are busy preparing for the fluid injection is substantially reduced.

[0052] Referring to FIG. 3A, a system 10b for reliably delivering a drug or fluid to a patient is shown according to a further embodiment. The system 10b includes a wearable electronic device 18 having a frame 20 in the form of head-mounted glasses. In the system 10b of FIG. 3A, the wearable electronic device 18 can be used, as described anywhere herein, in step (a) to visualize the fluid delivery device and in step (b) to visualize the patient ID 38 in the form of a wristband 40 worn around the patient's wrist. Note that in this specification, steps (a) and (b) can be accomplished in any order. The wristband 40 includes an identification tag 42 having a QR code. The patient ID 38 also includes a unique visual marker or display near the identification tag 42 or QR code that can trigger the image capture function of the wearable electronic device 18. When the unique marker is identified, the wearable electronic device 18 having a frame 20 in the form of head-mounted glasses starts processing the captured image to find and read the QR code. The patient ID 38 can also include additional encoding or identification techniques such as an NFC tag (e.g., RFID), a visual coding such as text that can be identified and read by an image processing function, a Bluetooth® or similar short-range data transmission antenna, and other proximity sensing technologies. The patient ID 38 includes information about the patient and can optionally be directly linked to an electronic patient record on a patient data system. The patient ID 38 can further include a technology that provides a location, such as GPS, to determine the patient's location. A technician can scan the patient ID 38 to obtain information about the patient, such as the procedure being performed, or the schedule for when future fluid deliveries should be performed, and any known medical conditions of the patient. Since the patient ID 38 links the wearable electronic device 18 to the patient's electronic record, any information or documentation taken during the procedure, such as the time of injection, the duration of the injection, or the volume of fluid being injected, can be transmitted to and stored in the patient's electronic record.As discussed herein, information is presented to the wearer of the wearable electronic device 18 by a display 16 attached to the glasses described with reference to FIG. 1.

[0053] Referring to FIG. 3B, as described above with reference to FIG. 3A, a system 10b for ensuring delivery of a patient's drug or fluid is shown, and the wearable electronic device 18 is provided in the form of a display 19 attached to the wrist, such as a smartwatch. As described herein, the system of FIG. 3B functions in the same manner as the system of FIG. 3A, except that the display 16 is adjusted via a display 19 attached to the wrist that is physically located on the user's wrist and provides a similar function as the display 16. In the system 10b of FIG. 3, the wearable electronic device 18 can be used, as described anywhere herein, in step (a) to visualize the fluid delivery device and in step (b) to visualize the patient ID 38 in the form of a wristband 40 worn around the patient's wrist. Note that in this specification, steps (a) and (b) can be accomplished in any order.

[0054] Referring to FIG. 4, a further embodiment of a system 10c for reliably delivering fluid to a patient is shown. System 10c is used to administer fluid to a patient via a fluid delivery device 28, such as an infusion set 44 that includes various fluid containers 46, i.e., intravenous (IV) bags, associated tubing 48, and a catheter 50 that extends into the patient's vein. Tubing 48 can further include one or more access ports 52. A syringe 54 can be connected to access port 52 to provide additional or different types of medical fluid to the patient. As in the previously described embodiments, system 10c includes a wearable electronic device 18, a fluid delivery device 28, and an identification tag 30 that is readable by the wearable electronic device 18. Identification tag 30 includes or is associated with identification information regarding fluid delivery device 28. System 10c verifies the procedure being performed and the fluid being infused, identifies the necessary devices and equipment, confirms that the fluid is being administered to the patient, and records the procedure.

[0055] In some embodiments, system 10c can be configured to verify that infusion set 44 is properly attached and connected. For example, an image processing function can identify the various connection points of infusion set 44, fluid container 46, and catheter 50. System 10c will then verify that the components are properly connected. If a proper connection is not identified, system 10c can alert a technician to check the connections before initiating fluid delivery. System 10c can also provide various other device maintenance alerts. For example, system 10c can alert a technician when a predetermined dwell time limit has been reached. Similarly, system 10c can alert a technician at various intervals when system maintenance should be performed.

[0056] In some further embodiments, system 10c is configured to visually monitor the drip count of infusion set 44 to establish and confirm the fluid delivery rate. For example, the image capture function of wearable electronic device 18 can record the time of insertion of catheter 50. The image capture function will then record the outflow port of fluid container 46 and the fluid droplets flowing from catheter 46 into infusion set 44 over a predetermined time period. The image processing function of wearable electronic device 18 identifies individual fluid droplets and estimates the fluid delivered to the patient over a period of time. System 10c can be configured to send a warning when a sufficient period of time has elapsed with respect to the delivery of a predetermined volume of fluid.

[0057] Referring to FIGS. 1-4, when using systems 10a, 10b, 10c, a technician wears the wearable electronic device 18. For example, the technician can wear the wearable electronic device 18 at the start of a shift or before initiating a particular infusion or fluid delivery procedure. When the wearable electronic device 18 is in place and powered on, the wearable electronic device 18 can display a start screen that provides the technician with initial instructions such as the patient to be visited and a task list with the procedures to be performed. The wearable electronic device 18 can also question the technician to confirm their identity in order to ensure that the correct person has received the correct instructions. When first contacting the patient, the technician uses the wearable electronic device 18 to capture an image of the patient ID 38. Based on information about or associated with the patient ID 38, medical information about the patient, including the infusion to be performed, is obtained. The information obtained is displayed on the user interface 110 along with instructions for performing the procedure. Based on the instructions displayed, the technician can obtain the items necessary for the infusion, including the appropriate fluid delivery device 28 and, if necessary, a medical fluid vial or cartridge for loading into the fluid delivery device 28. When the operator "sees" the infusion device and other items within their field of view 100, the wearable electronic device 18 identifies and reads the identification tag 30 attached to the item. Systems 10a, 10b, 10c can check the medical supply items obtained to confirm that only the items necessary for the procedure have been obtained and that no additional items are needed. When the items are obtained and identified by the system, the instructions on the user interface 110 are updated. For example, a confirmation message can be displayed on the user interface 110 if the correct item has been obtained. If an incorrect item has been obtained, a warning can be presented to the technician. The warning can be visual, such as an icon displayed on the user interface 110, as well as tactile, auditory, or any combination thereof.

[0058] After the item is obtained, the technician performs a medical procedure. When the technician performs the procedure, the infusion operation is monitored to verify the infusion. For example, the wearable electronic device 18 can ensure that the needle 36 has been inserted into the patient's skin and that the fluid has been discharged from the fluid delivery device 28. Information including the time and date of the infusion, as well as the name of the technician, is recorded and can be transmitted to an external system such as a patient data system. Thus, the information collected can be automatically included in the patient's digital record. The information can also be transmitted to a third-party insurance provider for billing purposes or as needed.

[0059] In some further embodiments, the time and date information can be used to establish a baseline for future medical procedures. The baseline can be used to determine how long an infusion should be performed or to set the number of times to check the infusion set 44. Similarly, when injecting from a syringe or injector, the baseline time data can be used to schedule the next treatment. Based on this information, the systems 10a, 10b, 10c can be configured to indicate an alert or warning on the user interface 110 when a subsequent treatment should be provided.

[0060] According to another aspect of the present invention, and referring also to FIGS. 5 and 6, a system 10d and method for obtaining a test sample for medical testing and diagnosis are shown. The system 10d is advantageous in that it provides an automated, non-clinically disruptive, hands-free method for establishing specimen identification, collection confirmation, sample and result tracking, and integration into a patient data information system. The system 10d is configured to track the process management of a fluid sample that begins when the sample is obtained and can continue through the sample test or reported result. Further, the system 10d is automatically integrated with an existing patient data system, and thus information regarding the type of sample collected and the tests performed can be displayed to the technician.

[0061] As described in the previous embodiments, system 10d includes a wearable electronic device 18. System 10d also includes a blood sampling device 56 that can be part of a larger extravascular fluid collection system. The blood sampling device 56 provides a fluid connection between the larger extravascular fluid collection system and the interior of the specimen collection container 55. The blood sampling device 56 includes generally a spike or port at its distal end. The specimen collection container 55 can be inserted onto the spike or port to collect a fluid sample through the blood sampling device. The blood sampling device 56 can also be configured to expel a small amount of fluid sample, such as a discontinuous number of droplets, through an opening proximal to the blood sampling device 56. The extravascular system includes invasive access devices such as the blood sampling device 56, the specimen collection container 55, the extension tube 57, and the vascular access device (shown in FIG. 10). Alternatively, the sampling device 56 can be directly connected to an intravenous catheter hub without using additional components such as the extension tube 57 to reduce the number of components and simplify the collection and sampling process.

[0062] System 10d can further include a point-of-care testing device 58. Test strips, slide glasses, and diagnostic cartridges are point-of-care testing devices 58 that receive a blood sample and test the blood for one or more physiological and biochemical conditions. Examples of test cartridges include the i-STAT® test cartridge from the Abbott corporate group. Test cartridges such as the i-STAT® cartridge can be used to perform tests on various conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers.

[0063] As is known in the art, the blood sampling device 56 can be disconnected from the extravascular fluid collection system, as indicated by arrow 210. The disconnected blood sampling device 56 is used, as indicated by arrow 212, to direct a portion of the fluid sample to a point-of-care testing device 58. The fluid sample is made to change color or undergo some other distinguishable transformation in the point-of-care testing device 58 and is read by the testing instrument and used therewith to identify whether any analytes are present in the fluid sample. In some embodiments of the system 10d, the wearable electronic device 18 may be configured to capture an image of the point-of-care testing device 58 being used. The image processing function may be configured to read the point-of-care testing device 58 and determine the test results. Alternatively, the image can be transmitted to a remote location where it can be read or interpreted by an appropriate medical professional.

[0064] As in previous embodiments of the system 10d, the system 10d includes identification tags 30 attached to various containers or blood sampling devices 56, invasive access devices such as vascular access devices, and point-of-care testing devices 58. The identification tag 30 includes or is associated with identification information regarding the container or device. The identification information can include the type of blood sampling device 56 or container, the procedure for which the container or device is used, or the volume of fluid in the sample obtained. The identification information can also include a unique designation for each container, enabling the system 10d to track the container after the fluid sample has been placed therein. As in the previously described aspects of the present invention, the identification tag 30 can be any type of display, such as a barcode or QR code, that can be read by the image capture function of the wearable electronic device 18. The identification tag 30 can also be an NFC tag, such as an RFID tag, that can be read by an antenna or transmitter associated with the wearable electronic device 18.

[0065] System 10d can also include a patient ID 38, such as a wristband 40 worn by the patient. The patient ID 38 includes an identification tag 30, such as a QR code, that includes or is associated with patient information. The patient ID 38 enables the wearable electronic device 18 to access the patient's electronic information, such as patient information stored on an external patient database system. The wearable electronic device 18 is configured to receive patient data and display relevant information to the technician.

[0066] Referring to FIG. 6, the wearable electronic device 18 enables the technician to view a virtual layer 22 that includes a user interface 110. The user interface 110 is designed to provide relevant important information to the technician in an easy-to-understand manner. An exemplary user interface 110 is shown in FIG. 6. However, it should be understood that the information, content, and design of the user interface 110 can be adapted to a particular type of medical facility or medical procedure. The appearance of the interface 110 can also be adapted based on the preferences of a particular technician.

[0067] The user interface 110 includes one or more information portions that display information about the patient, the tests to be performed, the containers used, and other related data. For example, the user interface 110 can include a portion 118 that has patient identification information such as a patient ID number. The patient information portion 118 can also include information about the type of sample ordered and a visual confirmation when the ordered sample was obtained. The user interface 110 can also include an identification tag portion, such as an identification tag confirmation icon 116. The identification tag confirmation icon 116 can include a visual display when the identification tag 30 is recognized and correctly read. The user interface 110 can also include a sample collection portion 120 that shows an icon 122 of a sample collection container, such as a test tube. The icon 122 can change appearance when the sample is safely sealed within the container. In some embodiments, the icon 122 can visually indicate that the container is filled with a liquid sample and can display a visual warning when a sufficient volume of liquid has been obtained.

[0068] When used, the technician can start by placing the patient ID 38 within the field of view 100 of the wearable electronic device 18 and scanning the patient ID 38 so that the patient information can be read by the wearable electronic device 18. Based on the patient information, details about the patient and the tests to be performed are displayed to the technician on the user interface 110. The technician can then collect the blood sampling device 56 and other items needed for the particular procedure to be performed. In some embodiments, the wearable electronic device 18 can recognize each item when obtained by the technician, for example, by recognizing and reading an identification tag 30 attached to the item. The user interface 110 can inform the technician after each required item has been obtained. The user interface 110 can also display a warning if a required item has not yet been obtained or recognized.

[0069] The user interface 110 can then display instructions for obtaining a fluid sample. These instructions can include the required fluid volume, the suggested vascular access site, or any other relevant information. The technician then collects the sample in the blood sampling device 56 or other suitable container. The image capture function of the wearable electronic device 18 can capture an image of the sampling device 56 or container filled with the sample and can warn the technician when a sufficient volume of fluid has been obtained. After the sample has been obtained, the technician can seal the sampling device 56 or container. The image capture function of the wearable electronic device 18 can record that the sample has been obtained and can record the time and a unique identification number for the sampling device 56 or container. In this way, the container is electronically linked to a specific patient, reducing the likelihood that the sample will be lost or misidentified for the wrong patient.

[0070] When point-of-care testing should be performed, details regarding the performance of the test may be presented to the technician. The technician may prepare the test device 58, for example, by placing it on a table or other suitable surface. The surface is preferably white or a similar high-contrast color to improve the image quality of the test device 58 acquired by the wearable electronic device 18. The identification tag 30 of the test device 58 is identified and recorded by the image capture function. The technician can then perform the test, for example, by placing a drop of the liquid sample on the test device 58. The system 10d can wait for a predetermined period for the test being performed and then obtain an image of the used test device 58. The captured image can be processed to determine the test result. Alternatively, the technician can visually determine the test result and record the information using the data input function of the wearable electronic device 18. If the test device 58 needs to be stored and sent to a laboratory or other facility, the image capture function can record the identification tag 30 and identification information regarding the specific test device 58 used to ensure proper process management. As in the previous embodiments of the system 10, the wearable electronic device 18 monitors each step of the sample acquisition and testing process. If the technician misses a step, the user interface 110 will warn the technician and provide instructions for correcting any errors.

[0071] According to another aspect of the present invention, and with reference to FIGS. 7-10, a system 10e is shown for improved visualization during insertion of an invasive access device, such as a vascular access device 60, and for evaluation of an indwelling vascular access device 60. The vascular access device 60 can be any suitable device for injection or for obtaining a fluid sample from a vein, including but not limited to a syringe, a hypodermic needle, a peripheral intravenous catheter, a blood collection set, a central venous line, or any combination of these elements. Exemplary vascular access devices 60 include straight, ported intravenous catheters, such as the AUTOGUARD™ shielded catheter, integrated peripheral intravenous catheters, winged needle sets, and blood collection sets, by Becton, Dickinson and Company. An exemplary catheter used with the present system is shown in FIG. 10. As in the previously described embodiments, the system 10e can be integrated with a patient data system to identify the medical procedure being performed and to perform treatment verification.

[0072] The system 10e includes the wearable electronic device 18 described in detail above. The system 10e further includes a vascular access device 60. The vascular access device 60 can include one or more identification tags 30 that contain or are associated with information regarding the vascular access device 60. The information can include, but is not limited to, needle gauge and length, as well as patient information, time, date, and other patient- or procedure-specific parameters, and other relevant information required for a particular procedure. The system 10e can further include a patient ID 38 (shown in FIG. 3) worn by the patient. The patient ID 38 allows the system 10e to automatically identify the patient and can be linked to the patient's electronic record.

[0073] In some embodiments, the wearable electronic device 18 also includes or is associated with additional systems, such as ultrasonic or other scanning devices that externally or internally improve anatomical structures. This improved anatomical structure can assist the technician in positioning the vascular access device 60 by providing a visual indication (e.g., virtual trace 62) of the position of the vein suitable for needle insertion. The technician can direct the needle of the vascular access device 60 based on the position of the virtual trace 62.

[0074] In some embodiments, the virtual trace 62 is projected onto the technician's field of view 100 using the display function of the wearable electronic device 18. The virtual trace 62 can be a computer-generated image or icon indicating where the vein is located. The position of the vein can be determined by several different image processing techniques. In one embodiment of the system 10e, an image of the injection site is captured by the image capture function of the wearable electronic device 18. Image processing performed on the captured image identifies various anatomical markers on the image. For example, the anatomical position of parts of the arm (e.g., wrist, elbow, finger, etc.) can be identified. In an alternative embodiment, the anatomical markers can be placed directly on the exterior of the patient's skin or applied to a bandage. Based on the positions of these anatomical markers, the distances between the markers, and the orientation of the arm relative to the image capture function, the dimensions and shape of the arm can be calculated. After the position and dimensions of the arm are identified, an approximate vein position can be estimated. Based on these estimates, the virtual trace 62 is projected onto the technician's field of view 100 at the approximated position. The virtual trace 62 can be viewed on the real layer 24 of the field of view 100, including the patient's arm.

[0075] Referring to FIG. 8, in some embodiments, visualization based on anatomical positioning is enhanced based on readings obtained using various external imaging devices such as ultrasound, infrared imaging, magnetic resonance imaging (MRI), or combinations thereof. As shown in FIG. 8, system 10e includes a control module 66 and an external ultrasound monitor 64 attached to a wand 68 or scanner. The control module 66 can include an integrated display. The ultrasound monitor 64 can be used to obtain an initial image of the anatomical structure of a patient's blood vessels prior to performing an invasive procedure. The ultrasound image obtained can help anatomically distinguish between arteries and veins, can help determine which vein is most suitable for a particular vascular access, and can assist in selecting the correct catheter dimensions and length for a particular vein. Images of the injection site captured by digital camera 12 can be captured simultaneously with the ultrasound scan to facilitate lining up the two images.

[0076] After an image is acquired and the desired invasive access site and vein are determined, this location information is transmitted to the wearable electronic device 18 and used with the anatomical positioning information obtained by processing the captured image to determine the position relative to the virtual trace 62. The approximate positions of the preferred vein and injection site are projected into the technician's field of view 100 (shown in FIG. 10). The virtual vein trace 62 can be color-coded or animated to provide the technician with additional information. For example, vein diameter information can be projected next to each virtual vein trace 62 to assist the technician in selecting a vein of the appropriate size and in selecting a catheter of the appropriate size. Similarly, veins of different sizes can be displayed in different colors to assist in the selection process.

[0077] Integrating data obtained by an imaging device such as an ultrasonic wave improves the selectivity, accuracy, and specificity of external visualization information projected to a technician. Therefore, the technician can be confident that the displayed vein position is correct and the vein is of a size suitable for the type of vascular access device 60 to be used.

[0078] The ultrasonic image of the venous anatomical structure can be locally stored on the wearable electronic device 18 or transmitted to an external data device such as a patient database system for inclusion in the patient's record. The ultrasonic image can then also be automatically provided for subsequent vascular access treatment to assist in vein selection.

[0079] After the insertion is performed, the system 10e can be configured to acquire real-time ultrasonic images to confirm that the needle of the vascular access device 60 is correctly positioned within the vein. Similarly, the system 10e can record the time and date stamp regarding the insertion and include such information in the patient's record. The system 10e can also record the position of the vascular insertion. This information can be used to prevent repeated insertions in the same area of the patient's body.

[0080] In some further embodiments, the ultrasonic monitor 64 can be configured to provide real-time information to the technician. For example, the user interface 110 of the wearable electronic device 18 can be configured to provide real-time images obtained using the ultrasonic monitor 64 in the technician's field of view 100. In this way, the technician can also "watch" the insertion process to ensure that the vascular access device 60 is correctly inserted into the desired vein. Such real-time information allows the technician to make corrections in response to changes in anatomical structures and device positions that may occur during the insertion process. Similarly, such a real-time system can be useful for evaluating the viability, position, and changes in the venous structure of the indwelling vascular access device 60. Thus, the technician can better determine when the indwelling vascular access device 60 needs to be removed or repositioned.

[0081] In further embodiments, the wearable electronic device 18 can include means for performing subcutaneous illumination by projection or emission of light, such as light provided by one or more LED bulbs or laser light pipes on the patient's skin. The projected light can improve visualization of the veins and can be used to improve the quality of the captured images. The improved, captured images can be used to improve the approximated virtual trace 62 provided by the image processing function. Inter-cannula illumination, or illumination using catheter stripes, can also be used to enhance the actual visualization of arteries and veins included within the scope of the present invention.

[0082] The invasive devices of the system can also be composed of materials that can be magnetized for use in an ultrasonic system, which utilizes a magnetic function to improve visualization and provides a projection means in the form of a path as the invasive device moves towards the target anatomical structure.

[0083] Similar to the previously described system 10e, the user interface 110 projected onto the virtual layer 22 of the technician's field of view 100 is advantageous for conveniently conveying important information regarding the procedures being performed, the devices being used, and the progress of the insertion process to the technician without using hands. Referring to FIG. 8, the overall user visual experience of the system 10e includes having a virtual layer 22 projected onto the technician's field of view 100 (shown in FIG. 10) that emphasizes the anatomical structure of the patient's blood vessels and provides the technician with improved insertion success. FIG. 9 is a schematic diagram of a virtual vein trace 62 including a portion of the patient's arm.

[0084] Referring to FIG. 10, a further embodiment of the technician's field of view 100 including the virtual layer 22 projected onto the reality layer 24 is shown. The virtual layer 22 includes a user interface 110 consisting of a heading bar 112, and the heading bar 112 includes patient identification information and information regarding the procedure being performed. The user interface 110 also includes a warning portion 124 that indicates to the technician when the needle of the vascular access device 60 is within a vein or when the needle has been inserted, and the projected trajectory of the invasive device while the invasive device is positioned relative to the subcutaneous anatomical structure targeted. The user interface 110 also includes one or more schematic images 126 that indicate the position of the needle relative to the vein. For example, one schematic image 126A shows the position of the needle relative to the vein from a top view and can indicate to the technician whether the needle needs to be moved left or right, forward or backward. The user interface 110 can also include a second schematic image 126B that depicts an elevation or side view indicating the depth of the needle relative to the vein. It is further contemplated herein that additional schematic drawings showing other images or views of the desired structure may be provided for viewing in the user interface 110. For example, other views can include cross-sectional views of the image shown in the first schematic image 126A or the second schematic image 126B. Alternatively, an image obtained from out-of-plane, such as an ultrasound probe, may also be provided. Finally, the user interface 110 can include icons 128 that indicate certain information regarding the vascular access device 60, such as the thickness or length of the catheter or needle.

[0085] When used, the technician begins by determining which procedures are to be performed and obtaining the necessary equipment. As in the previous embodiments of System 10e, the technician can determine this information by scanning the patient ID 38. Based on the information obtained from the patient ID 38, the user interface 110 can display instructions regarding the procedures to be performed, instructions regarding which items need to be obtained, and any other relevant information regarding the procedure or patient. The technician then obtains the items for the procedure, i.e., the vascular access device 60. The System 10e can verify that the correct items have been obtained by scanning the identification tag 30 for each item. A warning can be displayed if the technician fails to obtain the required items.

[0086] Before performing an injection or vascular access procedure, the technician can use a wand 68 or scanner of an imaging device, such as the ultrasound monitor 64, to scan the desired insertion site and obtain a subcutaneous three-dimensional image of the patient's vascular system. The System 10e can automatically process the obtained image and identify a vein suitable for insertion of the vascular access device 60. While the vein is being identified, an image of the injection site is also obtained using an image capture function, such as the digital camera 12 of the wearable electronic device 18. Processing the captured image identifies various anatomical markers, which are used to determine the dimensions, shape, and orientation of the patient's arm, or other selected injection site. Based on these processing operations, a trace of the vein, herein referred to as the virtual vein trace 62, is shown to the technician on the user interface 110. The technician positions the needle of the vascular access device 60 based on the virtual trace 62. The technician then inserts the needle into the vein. The user interface 110 can display a warning or confirmation when the needle is correctly positioned.

[0087] In addition to assisting with needle positioning, system 10e records the insertion operation to confirm that the procedure was actually performed correctly. For example, the time of insertion, the insertion location, the name of the technician, the insertion site, and other information can be transmitted from the wearable electronic device 18 to the patient data system. The information is recorded to assist in performing future insertion procedures.

[0088] Although specific embodiments of the invention have been described in detail, those skilled in the art will understand that various modifications and alternative forms can be developed in view of the teachings of the present disclosure as a whole. Accordingly, the specific configurations disclosed are merely exemplary and do not imply any limitation as to the scope of the invention, which scope should be given the full breadth of the appended claims and any and all equivalent forms thereof. Further, the invention has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments, but such details are for that purpose only, and the invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent configurations included within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, to the extent possible, one or more functions of any embodiment can be combined with one or more functions of any other embodiment.

Claims

1. A housing, at least one imaging sensor enclosed within the housing or associated with the housing, a data transmission interface for transmitting data to or receiving data from an external electronic device, a data reporting accessory for providing information to a user, a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory, a program for acquiring and processing images obtained by the at least one imaging sensor of an infusion set for delivering one or more therapeutic agents from a fluid container to a patient via a vascular access device comprising an electronic device, wherein the program verifies that the infusion set is correctly connected by identifying connection points between portions of the infusion set on an image of the infusion set captured by the at least one imaging sensor, and processes a portion of the image including the connection points to determine whether the connection is sufficient, a system.

2. The electronic device includes a wearable electronic device configured to be worn by the user, The system according to claim 1.

3. The program determines the flow rate of the fluid discharged from the fluid container and determines the fluid flow velocity from the fluid container by processing a series of images captured by the at least one imaging sensor, The system according to claim 1.

4. The data reporting accessory warns the user when the program determines that the connection is insufficient, The system according to claim 3.

5. The data reporting accessory warns the user when a predetermined dwell time limit is reached, The system according to claim 3.

6. The data reporting accessory warns the user when system maintenance should be performed, The system according to claim 3.

7. The at least one imaging sensor includes a digital camera or a digital video camera, The system according to claim 1.

8. The infusion set includes the fluid container, a tube, and a catheter extending into the patient's vein, The system according to claim 1.

9. The tube includes one or more access ports configured to be connected to a syringe, The system according to claim 8.

Images