JP2017510880A - System and method for collection confirmation and sample tracking during clinical use - Google Patents

Abstract

A system is provided for confirming the acquisition of a liquid sample. The system includes a wearable electronic device configured to be worn by a user. The 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 the external electronic device, at least one imaging sensor and data transmission A microprocessor for managing the interface and a program for acquiring and processing an image acquired by at least one image sensor. The system further includes a sampling device for collecting the fluid sample in the sample container and at least one identification tag attached to or integrally formed with the sampling device or sample container. The at least one identification tag includes or is associated with a tracking code.

Description

  The present invention relates to systems and methods for confirming and tracking sample collection procedures, and more particularly to systems and methods that operate without the use of a wearable electronic device.

  Blood sampling is a common health care procedure that involves drawing at least one drop of blood from a patient. Blood samples are collected from hospitalized, home care, and emergency room patients, generally 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, clotting, and the like.

  Similarly, fluid delivery to a patient is accomplished using a variety of vascular access devices including syringes, automatic injectors, pen injectors, catheters, and infusion devices. In a medical setting, a clinician or technician performs an injection by inserting a needle into the patient's vein. The therapeutic agent is provided to the patient via a needle, either directly or passively. For example, a medical technician can inject liquid by pushing a piston rod and plunger through the syringe barrel and drain the liquid therefrom. Alternatively, the therapeutic agent can be passively provided from the IV bag via the infusion set.

  Prior to performing a fluid sampling or fluid delivery procedure, the clinician or technician is responsible for obtaining any necessary medical instruments and devices. The clinician or technician can also be responsible for making an initial visit to the patient by examining body temperature, heart rate, or breathing. The clinician or technician will review the patient's medical record, or other printed instructions, to ensure that these initial steps are performed correctly and that any necessary equipment is available. Can be guaranteed. Alternatively, the technician can scan a bar code or identification on the instrument obtained to record that some items are being used. The medical professional then obtains a fluid sample or performs a fluid injection. After the sample has been collected or fluid has been injected, the clinician or technician may need to properly document that the procedure is complete. For example, a clinician or technician can write a description in the patient's chart that includes a record of the time that the procedure was completed, a description of the procedure that was performed, and any unusual or unexpected event. In addition, when obtaining a liquid sample, a medical professional can be responsible for closing or sealing the collected sample with an anti-tamper seal so that the sample is not damaged prior to testing. . The technician or clinician may be responsible for verifying the seal, for example, by signing his name or initials on a tearable label covering the seal.

  In many medical facilities, these preparation, confirmation, and documentation operations are performed manually by a clinician or technician when the medical procedure is being performed or after the procedure has been completed. For example, a clinician or technician may be responsible for manually labeling each collected fluid sample with identifying information about the patient before transferring the sample for examination. Similarly, the clinician or technician can be responsible for manually recording the type of fluid infused into the patient in the patient's chart. Medical professionals can also be expected to record the date and time the procedure was performed. In some situations, the clinician or technician comprises an electronic recording means such as a computer, laptop computer, table PC, smart phone, or similar easily movable computing device. However, the technician or clinician is still responsible for manually entering information into the electronic device. Alternatively, the data entry technician can be responsible for electronically entering information regarding the procedure performed based on records taken by the clinician or technician. In addition, many large medical facilities utilize electronic patient databases 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 a contemporaneous record taken by the clinician or technician. To do.

  Numerous manual steps required before, during and after fluid sampling or fluid delivery procedures create an opportunity for user error. User errors can result in incomplete or incorrect procedures, or can result in loss of patient data. For example, a clinician or technician may inject an incorrect volume, incorrect liquid type or concentration, or may not obtain a sufficient volume of liquid sample for the test being performed. is there. A medical clinician or technician may also forget to correctly record that a fluid sample was obtained or under what conditions the sample was obtained. In addition, the clinician or technician may fail to correctly record which patient has provided a particular fluid sample. These problems can harm the patient or at least require several fluid sample treatments 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 assists a clinician or technician in performing and recording medical procedures. The system should be configured to prevent errors that commonly occur during such procedures and should provide visual or audible warnings when errors occur. The system should also be automatically integrated with existing patient data systems, so information regarding the type of procedure to be performed is easily accessible to the clinician or technician. Further confirmation that the procedure has been performed, and associated information regarding the procedure, can be provided automatically and directly 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 issues.

  The systems and methods provided herein reduce the risk of drug infusion and delivery errors, and clinical work to identify, confirm and record drug and fluid delivery to a patient To improve the flow. These identification, confirmation, and documentation operations are accomplished in real time and clinical use.

  The system is designed to provide such benefits without the use of hands during clinical use. Similarly, systems and methods are also provided for establishing reliable chain of custody from the time of collection through reporting of results. The system establishes specimen identification, collection confirmation, sample and result tracking, and integration into patient data systems in an automatic, non-clinically disruptive, hands-free manner Make it possible. Finally, the system can further provide improved visualization to increase success during insertion of the vascular access device. The system and method provide a means for visualization and mapping of vascular anatomy, venous and device selection assistance, and successful insertion of a vascular access device (or other subcutaneous injection device), and indwelling vascular access in use. Evaluation of the device (peripheral IV catheter, blood collection set, peripherally inserted central venous catheter (PICC), central venous line, etc.) can be included.

  In view of these claims to be beneficial, according to aspects of the present invention, a system for tracking hand-free verification and inspection samples is provided. The system includes a wearable electronic device configured to be worn by a user. The device includes at least one imaging sensor encapsulated in or associated with the housing, a data transmission interface for sending data to or receiving data from the external electronic device, and at least one A microprocessor for managing two image sensors and a data transmission interface, and a program for acquiring and processing an image acquired by the image sensor. The system further includes a sampling device for collecting a liquid sample in the sample container and at least one identification tag attached to or integrally formed with the sampling device or sample container. The identification tag includes or is associated with a tracking code. The program processes the image captured by the imaging sensor to identify the identification tag and determine the tracking code. In addition, the program sends confirmation that the sample has been acquired and a tracking code to the external electronic device via the data transmission interface. Image capture, image processing, and data transmission are performed automatically without the need for user input or manipulation.

  According to an 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 associated with the housing, a data transmission interface for sending data to or receiving data from the external electronic device, and at least one imaging sensor. , And at least one microprocessor for managing the data transmission interface, and a program for acquiring and processing images acquired by the at least one imaging sensor. The system further includes a sampling device for collecting the liquid sample in the sample container and at least one identification tag attached to or integrally formed with the sampling device or sample container, wherein the at least one identification tag is Contains or is associated with a tracking code. The program processes the image captured by the at least one imaging sensor to identify at least one identification tag and determine a tracking code. The program also transmits confirmation that the sample has been acquired and a tracking code to the external electronic device via the data transmission interface. Image capture, image processing, and data transmission are performed automatically without the need for user input or manipulation.

  In some configurations, the system further includes a data reporting accessory for providing data to the user. Optionally, image capture, image processing, and data transmission are managed by the program without the use of hands. The sampling device can be a vascular access device, a phlebotomy set, a renal catheter, a tissue sampling device, or any combination thereof. The vascular access device can be a peripheral IV catheter, a PICC line, or a central venous line.

  The wearable electronic device can be a head-mounted computer, and the data reporting accessory can be a projection prism configured to project the virtual layer onto the user's field of view. The virtual layer can include a user interface, which includes a patient information portion, a sample collection confirmation portion, an identification tag confirmation portion, or any combination thereof.

  The at least one imaging sensor can be a digital camera or a digital video camera. The wearable electronic device can further include a data storage medium for storing a program, a sample collection confirmation, a tracking code for the sample container, or an image 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 enter data into the wearable electronic device. In some configurations, the peripheral data input device is a motion sensor, gyroscope, pressure sensor, accelerometer, touch pad, touch screen, or any combination thereof. Optionally, the wearable electronic device can include a power source within the housing of the wearable electronic device.

  The data transmission interface may be configured to send data to and receive data from the patient data system. Information received from the patient data system includes information regarding the procedure being performed, information regarding the type of fluid sampling device used, information regarding the amount of fluid sample required, information regarding suggested vascular access sites, or information regarding the patient. be able to. Information sent to the external electronic device includes confirmation that the sample was obtained, the time and date the sample was obtained, information about the location of the injection site, tracking code for the sampling device, or any combination thereof Can do.

  The identification tag can include a two-dimensional barcode, a three-dimensional barcode, a near field communication device, or a label having text that can be read by an optical character recognition algorithm. The program processes the image to determine the position of the position marker on the sampling device, and to determine the position of the at least one identification tag based on the position of the position marker, thereby determining at least one in the captured image. An identification tag can be identified.

  Optionally, the system can also include a patient identification device that includes or is associated with identification information about the patient, which can be read by at least one imaging sensor of the wearable electronic device. The system also removes a portion of the fluid sample to examine the fluid sample for one or more of the following: chemicals, electrolytes, hematology, blood gas concentration, coagulation, or cardiac markers. A point-of-care testing device configured to receive may be included. Point-of-care testing devices can be test strips, dipsticks, immunoassays, glass slides, or diagnostic cartridges.

  The program can be configured to capture an image of the point-of-care test device after the point-of-care test device is exposed to a portion of the fluid sample, and the program can also capture an image of the point-of-care test device. Process to determine the results of the point-of-care testing device. The point-of-care test device can include an identification tag associated with or associated with the point-of-care test device, and the program processes the image of the point-of-care test device to determine the identification information To do.

  The program verifies that a liquid sample has been collected by processing a series of images of the sample container captured by at least one imaging sensor, and when a minimum amount of liquid is present in the sample container. Can be determined. In some configurations, the wearable electronic device alerts the user when a minimum amount of fluid has been collected.

  According to another embodiment of the present invention, a method for verifying and tracking an acquired liquid sample includes collecting a liquid sample in a sample collection container of a sampling device, and the liquid sample is being collected. Sometimes using a wearable electronic device having at least one imaging sensor to acquire a series of images of the sample collection container and to determine when a predetermined fluid volume is present in the sample collection container Processing a series of images in real time. The system also includes notifying a user wearing a wearable electronic device that sample collection is complete when an image showing a sample collection container filled with a predetermined volume of liquid is acquired. The processing is automatically performed without requiring any operation by the user.

  In some configurations, the method also includes a series of steps for identifying and extracting information about the sampling device or sample collection container from an identification tag attached to or integrally formed with the sampling device or sample collection container. Processing at least one of the images. The information extracted from the identification tag can include a tracking code for the sampling device. The method may further include sending confirmation that the sample has been collected and a tracking code for the sampling device to an external source via the data transmission interface of the wearable electronic device. In some configurations, the wearable electronic device is a head-mounted computer that includes a projection prism configured to project a virtual layer containing information and instructions onto a user's field of view.

  These other features and characteristics of the invention, as well as the manner of operation and function of the combination of related elements and parts of the structure, the economics of manufacture, refer to the attached drawings, all of which form part of this specification. It will become more apparent from a review of the following description and the appended claims. In the figures, like reference numerals designate corresponding parts in the various figures. However, it should be clearly understood that the drawings are for illustration and description only and are not intended to define the limitations of the invention. As used herein in the specification and in the claims, the singular forms “a”, “an”, and “the” refer to other forms that are clearly shown in context. Unless indicated otherwise, it also includes multiple indication objects.

1 is a schematic diagram of a hand-free system for ensuring delivery of patient medication and fluids in accordance with the principles of the present invention. FIG. FIG. 2 is a schematic view of a field of view display for the system of FIG. 1 is a schematic diagram of a hand-free system for ensuring delivery of a patient's medications and fluids having a wearable electronic device in the form of glasses and a patient identification device in accordance with the principles of the present invention. 1 is a schematic diagram of a hand-free system for ensuring delivery of a patient's medication and fluid having a wearable device in the form of a wrist-mounted device and a patient identification device in accordance with the principles of the present invention. 1 is a schematic diagram of a hand-free system for ensuring delivery of patient medication and fluids in accordance with the principles of the present invention. FIG. 1 is a schematic diagram of a hand-free system for establishing test specimen identification and performing sample tracking in accordance with the principles of the present invention; FIG. FIG. 6 is a schematic view of a field of view display for the system of FIG. 1 is a schematic diagram of a system for performing improved visualization during insertion of an invasive device in accordance with the principles of the present invention. FIG. 1 is a schematic diagram of a system for performing improved visualization during insertion of an invasive device in accordance with the principles of the present invention. FIG. FIG. 9 is a schematic view of the field of view for the system of FIG. FIG. 10 is a schematic view of the field of view for the system of FIG.

  The following description is provided to enable any person skilled in the art to make and use the above-described embodiments that are intended to carry out the invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention. However, it should be understood that the invention may take on various alternative variations and sequences of steps, unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the particular dimensions and other physical characteristics associated with the embodiments disclosed herein are not to be considered as limiting. To facilitate an understanding of the present invention, the accompanying drawings and description show preferred embodiments thereof, from which the present invention, various embodiments of its structure, configurations and methods of operation, and many The advantages of can be understood and appreciated.

  The present invention is directed to systems and methods for identification, confirmation, and documentation without the use of various medical procedures in clinical use, including invasive procedures that require procedural guidance. To do. Exemplary procedures include, but are not limited to, drug and fluid delivery, specimen or sample collection, and / or vascular access procedures. The system improves on existing patient data systems by collecting and recording data without requiring positive action by a user or operator, referred to below as a medical technician. More specifically, the system does not require a user or operator, referred to below as a medical technician, to manually record information or is currently required by existing patient data systems, scanners, cameras, Enables necessary identification, confirmation, and documentation tasks to be performed without the need to operate a data input device such as a keyboard or touch screen. The system improves clinical workflow and data entry integrity by reducing the likelihood of technician error. In addition, the system reduces the risk of infection for patients and medical technicians. In particular, since the medical technician does not need to touch or manipulate the data input device, the risk of contamination of the input device is reduced.

  The system can be integrated with existing equipment, including disposable medical devices that have already been used, as well as with existing patient databases and patient monitoring software. Thus, the system does not require further equipment or capital base improvements at the healthcare facility. Similarly, the system can be easily integrated with specific medical facility procedures and practices.

  Referring to FIG. 1, a system 10a for ensuring and verifying fluid delivery to a non-handed patient during clinical use is shown. 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 the treatment to the external source. System 10a is provided to reduce the risk of drug errors at the time of dosing by providing real-time patient information, alerts, drug identification, and dosing confirmation without the use of hands.

  System 10a includes a wearable electronic device. In a preferred and non-limiting embodiment, the wearable electronic device is a wearable computer with augmented reality display, hereinafter referred to as “wearable electronic device 18”. An exemplary wearable electronic device 18 is Google Corp. , Mountain View, CA can be a head-mounted device such as glasses incorporating Google Glass technology created by CA. Although Google Glass technology is not currently commercially available, if Google Glass or a similar product is marketed, one skilled in the art would readily be able to implement with 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 may be a wrist attached device that also incorporates Google Glass technology. The wearable electronic device can also have other shapes and configurations based on the particular fluid delivery procedure being performed. For example, a wearable electronic device may be a button or pin attached to a medical technician's clothing, a watch worn on a wrist, a necklace, a pendant, or any other type of invisible, easily transportable item be able to.

  The wearable electronic device 18 includes a hat, helmet, face shield, wristband, or frame having a display portion 16, such as a projection prism, face shield, or wrist-worn display that extends into the medical technician's field of view. 20 (for example, one spectacle frame). The display portion 16 may be placed close to the wearer's eyes, such as in the case of a projection prism. 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 at a greater distance. For example, in the 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, but 25 viewed from 8 feet (2.44 m) away. Presents a viewable screen that appears similar to an inch (63.5 cm) screen. Augmented reality display projects a virtual projection or layer 22 that includes a portion of the wearer's field of view. The overall view of the medical technician is not obstructed by the virtual layer 22. The medical technician can still “see” the real layer 24 beyond or adjacent to the virtual layer 22.

  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 that can be viewed by a technician. The wearable electronic device 18 can also communicate treatment and patient information to the technician via other communication means including, but not limited to, audio alerts or tactile confirmation. For example, the wearable electronic device 18 can beep or vibrate to inform the technician that a problem has been identified.

  The attachable electronic device 18 further includes a computer housing 26 or housing attached to the frame 20. The housing 26 can be of any size necessary to hold the necessary associated electronic devices. Related electronic devices within computer housing 26 may include data collection devices and sensors, data transmission and communication circuitry, data processing circuitry, and data display and alerting devices and circuitry. The computer housing 26 is desirably sufficiently small and lightweight that does not cause substantial obstacles to the wearer or the operator when the operator performs normal functions and operations.

  The data collection device can include various sensors and recording devices to obtain information regarding the medical procedure 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 may be adapted to provide stationary or moving 2D image (s), or 3D anatomical scanning geometry. An image or video camera typically has a charge coupled device (CCD) or complementary metal oxide semiconductor (CMOS) imaging sensor, lens, multifunction video control / digital signal processing (DSP) chip, and a set of discrete components ( For example, a capacitor, a resistor, and a connector). 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 even on an external controller or computer. The lens can include a range of focus useful for imaging as described herein, or the video camera can include an autofocus function. Similarly, the lens can have a zoom function. The video control component on the chip performs several image acquisition tasks, while the DSP component on the same chip implements 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 (eg, voice command) input, a touch mechanism or trackpad for tactile input, an accelerometer, a gyroscope, and the like.

  Electronic communication and data transmission devices, as well as electronic circuitry, may include a data transmission interface 14 for sending and receiving data to and from external sources such as external electronic devices. The external device can be a data storage device, an external computer, a local computer network of several computing devices, or the Internet. For convenience, these external electronic devices will be collectively referred to as the cloud 15. The data transmission interface actually creates a personal area network (PAN) that includes a wearable electronic device 18, a data transmitter, and an external receiver attached to an external source. A PAN is a computer network used to communicate (eg, data transmission) among computer devices including telephones and personal digital assistants (PDAs) in close proximity to a technician's body. The PAN can be used to communicate within the personal device itself (intrapersonal communication) or to connect to higher level networks and the Internet (uplink). A wireless personal area network (WPAN) is enabled using wireless network technologies such as Bluetooth (registered trademark), WiFi, Z-Wave, and ZigBee. A WiFi (eg, IEEE 802.11a, b, g, n) networking protocol can be used, which is advantageous because it has a larger transmission range than Bluetooth®, but results in higher power consumption. Also has quantity. Suitable external sources for receiving data sent from the device and optionally processing the data are computers, tablet PCs or smartphones, and / or external hard drives, or for backing up stored data Including other devices.

  In some embodiments, the 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 the data transmission interface 14. These systems use a handheld electronic device to allow a user to remotely update patient data. 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 functionality to allow easy access to such data at the point of care. As a result of such integration with existing database software platforms, the 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. it can. However, unlike existing systems, the system 10a automatically updates patient data without the need for direct input from a medical technician. Thus, the system 10a is fully and automatically integrated into the patient data system. In contrast, previously, data was manually entered by a medical technician after the procedure was performed.

  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 is any type of non-volatile memory, such as, for example, a magnetic data storage medium such as a hard disk drive or magnetic tape, or a 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 embedded transaction file systems (ETFS), exFat, and FFS2 systems. The storage medium may be random access memory (RAM) or read only memory (ROM). The memory can be removed from the device or permanently installed in the housing and can be transferred to an external device via the data transmission interface 14.

  In one embodiment, the wearable electronic device 18 further includes one or more power sources such as a battery 23 contained within the computer housing 26. The battery 23 includes one or more electrochemical cells that convert the stored chemical energy into electrical energy. One non-limiting example of a useful battery is a lithium ion battery. Lithium ion batteries are rechargeable batteries that are often used in electronic devices. The capacity of the lithium ion battery is preferably sufficient to provide power to the wearable electronic device for a full day or more. However, in some cases where the device is not operated continuously, a smaller capacity battery is more appropriate to reduce device size and weight. Other types of batteries that can be adapted 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.

  The electronic devices and electronic circuits contained in the housing 26 of the attachable 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 memory of the chip. The microprocessor typically manages data collection from various sensors and digital cameras 12, along with other functions, directs data storage by the data storage system, and allocates system resources among the electronic components to consume power. Reduce the amount and reduce the need for overlapping 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 as well as for interacting with a 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.

  With continued reference to FIG. 1, the system 10a includes a fluid delivery device 28, such as a prefilled syringe, pen-type syringe, automatic syringe, infusion set, 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 that is integrally formed with or attached thereto. The identification tag 30 can be a standard two-dimensional barcode, a three-dimensional barcode (eg, a quick read (QR) code, etc.), as well as various manufacturer-specific encoded codes known in the art. It can be a computer readable tag and label. The identification tag 30 can be integrally formed on or within the liquid delivery device 28. Alternatively, the identification tag 30 can be printed on the liquid delivery device 28 or on a label adhered to the liquid 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 about the fluid delivery device 28 and the fluid contained therein, including drug type, total fluid volume, manufacturer, needle size, fluid warranty date, and the like.

  In some embodiments, the wearable electronic device 18 may 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 may be configured to identify various position markers on the fluid delivery device 28. The position marker may refer to the identification tag 30 and can trigger the wearable electronic device 18 to start capturing an image of the identification tag 30. Once the 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, for example, 3 seconds, which indicates that the wearable electronic device 18 is an image of the identification tag 30 until the position marker is in the field of view for at least 3 seconds. Means that no attempt is made to process or read. The time delay function preserves computing power by limiting when image processing is performed. In particular, only those identification tags 30 that are of sufficient interest for a technician to see 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 therefore not read.

  Alternatively, the identification tag 30 can be a standard medical label that includes standard printed characters and includes the name and amount of the drug or therapeutic agent. The wearable electronic device 18 may 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 additional tags or electronic positioning devices may not need to be added.

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

  In some embodiments, the identification tag 30 uses a selectively visible type of ink that can only be read at a particular time, such as immediately before the liquid delivery occurs, to provide the liquid delivery device 28. Can be printed or attached. After fluid delivery is complete, another or modified identification tag 30 may be visible to indicate the end of use or the completion of infusion.

  The system 10a can also include means for identifying when delivery of the fluid has occurred, or optionally, means for estimating the amount of fluid delivery. System 10a can monitor fluid delivery by tracking the movement of an actuation mechanism or fluid draining mechanism, such as plunger 32 or piston rod 34, during a fluid delivery procedure. In some further embodiments, the identification tag 30 can be used to estimate the position of the plunger 32 or piston rod 34. For example, the image processing software can record the initial position of the plunger 32 or piston rod 34 relative to the position of the identification tag 30. When the plunger 32 or piston rod 34 moves relative to the position of the identification tag 30, the image processing software determines that the injection has started. When the plunger 32 or piston rod 34 has advanced a predetermined distance from the identification tag 30, it can be assumed that the injection has been completed.

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

  In some embodiments, additional electronic or mechanical sensors can be associated with the fluid delivery device 28 to provide further evidence or confirmation of fluid delivery. For example, the sensor may be located near the injection needle 36 of the fluid delivery device 28. The sensor can record when the needle 36 has been correctly inserted into the patient and ensures that fluid has passed through the needle 36 and has been drained to the patient. Data collected by the sensor can be transmitted to the wearable electronic device 18 by a wireless transmitter, preferably a wireless transmitter such as Bluetooth®, adapted for near field communication. Inclusion of the sensor directly on the fluid delivery device 28 increases the complexity of the fluid delivery device 28 and associated electronic devices, but is advantageous because it provides further confirmation that fluid delivery to the patient has actually taken place. is there.

  In addition to being used to locate and read the identification tag 30 and provide end-of-dose confirmation, the image capture function of the wearable electronic device 18 also preserves the fluid delivery procedure. And can be used to record. For example, an image of an infusion process (eg, inserting a needle into a patient's vein, etc.), an image of an empty syringe, and an image of 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 timestamp can be used to update the patient's medical record with the exact time that the procedure was performed.

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

  An exemplary field of view 100 viewed by a technician wearing the wearable electronic device 18 and including both the virtual layer 22 and the real layer 24 is shown in FIG. As shown in FIG. 2, the virtual layer 22 includes a user interface 110. The user interface 110 may 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 header bar 112 or title can also include a description of the medical procedure being performed, or information regarding the type of infusion or fluid delivery device required. The user interface 110 may also include a syringe volume indicator icon 114 that indicates the estimated liquid remaining in the syringe. The icon 114 allows the operator to easily determine when all 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 be shown when the identification tag 30 is identified on the 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 is recognized. If the identification tag 30 cannot be located or if an incorrect identification tag 30 is found, the icon 116 can display a warning and indicate to the technician that an injection should not be performed.

  As described above, the virtual layer 22 does not block the operator's overall view 100. Therefore, the operator can still see the reality layer 24 even if the user interface 110 is visible. Thus, the technician can see any warnings while preparing to perform the procedure. As a result, the chance that the technician will miss the warning because he is busy preparing for infusion is substantially reduced.

  Referring to FIG. 3A, a system 10b is shown for ensuring patient drug or fluid delivery according to a further embodiment. 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 is used to visualize the fluid delivery device in step (a) and in step (b) as described elsewhere herein. Can be used to visualize the patient ID 38 in the form of a wristband 40 worn around the wrist. It should be noted herein that 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 may also include a unique visual marker or display near the identification tag 42 or QR code to trigger the image capture function of the wearable electronic device 18. When a unique marker is identified, the wearable electronic device 18 having a frame 20 in the form of head-mounted spectacles begins processing the captured image to find and read the QR code. Patient ID 38 is also an NFC tag (eg, RFID), visual coding such as text that can be identified and read by image processing functions, Bluetooth or similar near field data transmit antennas, and other Additional encoding or identification techniques such as proximity sensing techniques can be included. Patient ID 38 includes information about the patient and may optionally be linked directly to an electronic patient record on the patient data system. Patient ID 38 may further include a technique for providing a location, such as GPS, to determine the location of the patient. The technician scans the patient ID 38 to obtain information about the patient, such as the procedure to be performed, or a schedule regarding when future fluid delivery should be performed, as well as any known medical condition of the patient. Can do. Patient ID 38 links wearable electronic device 18 to the patient's electronic record, so any information or documents taken during the procedure, such as the time of infusion, duration of infusion, or volume of fluid to be infused The conversion can also be sent to the patient's electronic record and stored there. As discussed herein, the display of information is provided to the wearer of the wearable electronic device 18 on the display 16 attached to the glasses described with reference to FIG.

  Referring to FIG. 3B, as described above with reference to FIG. 3A, a system 10b is shown for ensuring the delivery of a patient's medication or fluid, and the wearable electronic device 18 is a smartwatch. Etc., provided in the form of a display 19 attached to the wrist. As described herein, except that the display 16 is adjusted via a display 19 that is physically located on the user's wrist but attached to the wrist that provides similar functionality as the display 16. The system of FIG. 3B functions similarly to the system of FIG. 3A. In the system 10b of FIG. 3, the wearable electronic device 18 is used in step (a) to visualize the fluid delivery device and in step (b) as described elsewhere herein. Can be used to visualize the patient ID 38 in the form of a wristband 40 worn around the wrist. It should be noted herein that steps (a) and (b) can be accomplished in any order.

  Referring to FIG. 4, a further embodiment of a system 10c for ensuring fluid delivery to a patient is shown. The system 10c is through various fluid containers 46, ie, fluid delivery devices 28, such as an intravenous treatment (IV) bag, associated tubing 48, and an infusion set 44 that includes a catheter 50 that extends into the patient's veins. Used to administer fluid to patients. Tube 48 may further include one or more access ports 52. Syringe 54 may be connected to access port 52 to provide additional or different types of medical fluids to the patient. As in the previously described embodiment, the system 10 c includes a wearable electronic device 18, a fluid delivery device 28, and an identification tag 30 readable by the wearable electronic device 18. The identification tag 30 includes or is associated with identification information regarding the liquid delivery device 28. System 10c confirms the treatment to be performed and the fluid to be infused, identifies the necessary devices and equipment, confirms that fluid is being administered to the patient, and records the treatment.

  In some embodiments, the system 10c may be configured to verify that the infusion set 44 is correctly installed and connected. For example, the image processing function can identify various connection points of the infusion set 44, the fluid container 46, and the catheter 50. System 10c will then verify that the elements are properly connected. If an appropriate connection is not identified, the system 10c can alert the technician to examine the connection before initiating fluid delivery. The system 10c can also provide various other device maintenance alerts. For example, the system 10c can alert a technician when a predetermined detention time limit is reached. Similarly, the system 10c can alert the technician at various intervals when system maintenance is to be performed.

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

  1-4, when using the systems 10a, 10b, 10c, a technician wears a wearable electronic device 18. For example, a technician can wear the wearable electronic device 18 at the beginning of a shift or before starting to perform a particular infusion or fluid delivery procedure. When the wearable electronic device 18 is in place and powered on, the wearable electronic device 18 provides initial instructions such as a task list with the patient to be visited and the procedure to be performed. The start screen to be provided can be displayed. The wearable electronic device 18 can also ask the technician to verify his identity to ensure that the correct instructions are given to the correct person. Upon first contact with the patient, the technician uses the wearable electronic device 18 to capture an image of the patient ID 38. Based on information relating to or associated with the patient ID 38, medical information about the patient is obtained, including the infusion to be performed. The obtained information is displayed on the user interface 110 together with instructions for performing the treatment. Based on the displayed instructions, the technician will select the appropriate fluid delivery device 28 and, if necessary, the items required for infusion, including a medical fluid vial or cartridge for loading into the fluid delivery device 28. Can be obtained. When the operator “sees” the infusion device and other items in its field of view 100, the wearable electronic device 18 identifies and reads the identification tag 30 attached to the item. The systems 10a, 10b, 10c can examine the resulting medical supplies to ensure that only the items needed for the procedure are obtained and no further items are needed. As items are obtained and identified by the system, the instructions on the user interface 110 are updated. For example, a confirmation message may be displayed on the user interface 110 if the correct item is obtained. A warning may be presented to the technician if an incorrect item is obtained. The alert can be visual, such as an icon displayed on the user interface 110, as well as tactile, audible, or any combination thereof.

  After the item is obtained, the technician performs a medical procedure. As 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 can ensure that fluid has been drained from the fluid delivery device 28. Information including the time and date of infusion, and the technician's name can be recorded and sent to an external system such as a patient data system. Thus, the collected information can be automatically included in the patient's digital record. The information may also be sent to a third party insurer for billing or as needed.

  In some further embodiments, time and date information may 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 examine the infusion set 44. Similarly, when injecting from a syringe or infuser, baseline time data can be used to schedule the next treatment. Based on this information, the systems 10a, 10b, 10c may be configured to indicate an alarm or warning to the user interface 110 when subsequent treatment is to be provided.

  In accordance with another aspect of the present invention and with reference to FIGS. 5 and 6, a system 10d and method for capturing and tracking relevant patient, procedure, and / or sample information is shown. System 10d may provide tracking of relevant patient, procedure, and / or sample information at multiple “connection points” throughout the process, such as through a process of obtaining a test specimen for medical examination and diagnosis. it can. This can be performed in order of inspection, with inspection result reporting and integration with EMR.

  System 10d provides an automated, non-clinically destructive, hand-free method for establishing specimen identification, collection confirmation, sample and result tracking, and integration into patient data information systems. It is advantageous. The system 10d is configured to track the fluid sample process management that begins when the sample is obtained and can continue through the specimen inspection or reporting results. In addition, the system 10d is automatically integrated with an existing patient data system so that information regarding the type of sample collected and the tests performed can be displayed to the technician.

  As in the previously described embodiment, the 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. Blood sampling device 56 provides a fluid connection between the larger extravascular fluid collection system and the interior of specimen collection container 55. Blood sampling device 56 generally includes a spike or port at its distal end. The specimen collection container 55 can be inserted over a spike or port to collect a fluid sample via a blood sampling device. Blood sampling device 56 may also be configured to discharge a small volume of fluid sample, such as a discrete number of droplets, through an opening proximal to blood sampling device 56. The extravascular system includes an invasive access device (shown in FIG. 10), such as a blood sampling device 56, a specimen collection container 55, an extension tube 57, and a vascular access device. Alternatively, the sampling device 56 can be connected directly to the intravenous catheter hub without the use of additional components such as extension tubes 57 to reduce the number of components and simplify the collection and sampling process.

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

  As is known in the art, blood sampling device 56 can be disconnected from the extravascular fluid collection system, as indicated by arrow 210. Disconnected blood sampling device 56 is used to direct a portion of the fluid sample to point-of-care test device 58 as indicated by arrow 212. When a liquid sample is read by and used with a test instrument, causing the point-of-care test device 58 to change color or undergo some other identifiable transformation, several analytes are Identify whether it is present in the liquid 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 used. The image processing function may be configured to read the point-of-care inspection device 58 and determine the inspection result. Alternatively, the image can be transmitted to a remote location where the image can be read or interpreted by an appropriate medical professional.

  As in the previous embodiment of system 10d, 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. Including. The identification tag 30 includes or is associated with identification information about the container or device. The identification information can include the type of blood sampling device 56 or container, the procedure in which the container or device is used, or the volume of the resulting sample. The identification information can also include a unique designation for each container, allowing the system 10d to track the container after placing a fluid sample 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.

  The 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 allows the wearable electronic device 18 to access patient 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 a technician.

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

  The user interface 110 includes one or more information portions that display relevant information about the patient, the tests being performed, the containers used, and other relevant data. This information includes collection / tracking of information from the inspection sequence through the entire process, collection and preparation of samples and supplies, confirmation of correct inspection device and shelf life, acquisition of inspection samples, tracking of process control, sample processing, samples Inspection, results, time, date reporting, and other relevant information throughout process management can be included. This may also include alerts to the clinician or EMR for any abnormalities to the directed laboratory procedure, patient information, or sample processing associated with the required laboratory procedure, and process control requirements. For example, the user interface 110 can include a portion 118 having patient identification information, such as a patient ID number. Patient information portion 118 may also include information regarding the type of sample indicated and a visual confirmation when the indicated 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 indication when the identification tag 30 is recognized and correctly read. The user interface 110 may also include a sample collection portion 120 showing a sample collection container icon 122, such as a test tube. The icon 122 can change the appearance when the sample is safely sealed in the container. In some embodiments, the icon 122 can visually indicate that the container is filled with a fluid sample and display a visual warning when sufficient fluid volume is available. Can do.

  In use, the technician begins by scanning the patient ID 38 with the patient ID 38 in the field of view 100 of the wearable electronic device 18 so that patient information can be read by the wearable electronic device 18. be able to. Based on the patient information, details regarding the patient and the exam being performed are displayed to the technician on the user interface 110. The technician can then collect the blood sampling device 56 and other items necessary for the particular procedure being performed. In some embodiments, the wearable electronic device 18 recognizes each item when it is obtained by a technician, for example by recognizing and reading the identification tag 30 attached to the item. Can do. The user interface 110 can inform the technician after each required item is acquired. The user interface 110 can also display a warning if the required item has not yet been acquired or recognized.

  The user interface 110 can then display instructions for obtaining a fluid sample. These instructions can include the required volume of fluid, suggested vascular access sites, or any other relevant information. The technician then collects the sample in 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 sample, and can alert the technician when a sufficient liquid volume is obtained. After the sample is obtained, the technician can seal the sampling device 56 or container. The image capture function of the wearable electronic device 18 can record that a 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 tied to a particular patient, reducing the likelihood that a sample will be lost or identified to the wrong patient.

  If a point-of-care test is to be performed, details regarding the performance of the test can be presented to the technician. The technician prepares the inspection 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 inspection device 58 acquired by the wearable electronic device 18. The identification tag 30 of the inspection device 58 is identified and recorded by an image capture function. The technician can then perform the test, for example, by placing a drop of liquid sample on the test device 58. The system 10d can wait for a predetermined period of time for the inspection to be performed and then obtain an image of the used inspection device 58. The captured image can be processed to determine inspection results. Alternatively, the technician can visually determine the test results and record the information using the data input function of the wearable electronic device 18. If the inspection device 58 is stored and needs to be sent to a laboratory or other facility, the image capture function will identify the identification tag 30 and the specific inspection device 58 used to ensure correct process control. Identification information can be recorded. As in the previous embodiment of the system 10, the wearable electronic device 18 monitors each step of the sample acquisition and inspection process. If the technician misses a step, the user interface 110 will alert the technician and provide instructions to correct any errors.

  In accordance with another aspect of the invention, and with reference to FIGS. 7-10, for improved visualization during insertion of an invasive access device, such as vascular access device 60, and indwelling vascular access. A system 10e for evaluation of device 60 is shown. Vascular access device 60 includes, but is not limited to, a syringe, hypodermic needle, peripheral intravenous catheter, blood collection set, central venous line, or any combination of these elements for infusion or intravenous fluid It can be any suitable device for obtaining a sample. An exemplary vascular access device 60 is a straight, ported intravenous catheter, such as Becton, AUTOGUARD ™ shielded catheter by Dickinson and Company, integrated peripheral intravenous catheter, winged needle set, and blood collection set. including. An exemplary catheter for use with the present system is shown in FIG. As with the previously described embodiments, the system 10e can be integrated with a patient data system to identify the medical procedure to be performed and to perform therapy confirmation.

  System 10e includes a wearable electronic device 18 described in detail above. System 10e further includes a vascular access device 60. Vascular access device 60 may include one or more identification tags 30 that include information associated with or associated with vascular access device 60. Information can include needle thickness and length, as well as other relevant information required for a particular procedure. 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.

  In some embodiments, the wearable electronic device 18 also includes or is associated with additional systems, such as ultrasound or other scanning devices that enhance the anatomy externally or internally. This enhanced anatomy can assist the technician in positioning the vascular access device 60 by providing a visual indication of the location of the vein suitable for needle insertion (eg, virtual trace 62). . The technician can direct the needle of the vascular access device 60 based on the position of the virtual trace 62.

  In some embodiments, the virtual trace 62 is projected onto the technician's field of view 100 using the display capabilities of the wearable electronic device 18. The virtual trace 62 can be a computer generated image or icon that shows where the veins are. 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 a portion of an arm (eg, wrist, elbow, finger, etc.) can be identified. In alternative embodiments, the anatomical marker may be placed directly on the exterior of the patient's skin or applied to the bandage. Based on the location of these anatomical markers, the distance between the markers, and the arm orientation with respect to the image capture function, arm dimensions and shapes can be calculated. After the arm position and dimensions 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 an approximate location. The virtual trace 62 can be seen on the reality layer 24 of the field of view 100, including the patient's arm.

  Referring to FIG. 8, in some embodiments, visualization based on anatomical positioning may be performed by various external imaging devices such as ultrasound, infrared imaging, magnetic resonance imaging (MRI), or combinations thereof. The improvement is based on the reading obtained using. As shown in FIG. 8, system 10e includes a control module 66 and an external ultrasonic monitor 64 attached to a wand 68 or scanner. The control module 66 can include an integrated display. The ultrasound monitor 64 may be used to obtain an initial image of the patient's blood vessel anatomy prior to performing an invasive procedure. The resulting ultrasound image can help to anatomically distinguish between arteries and veins, can help determine which vein is best suited for a particular vascular access, And it can assist in selecting the correct catheter size and length for a particular vein. The image of the injection site captured by the digital camera 12 can be captured simultaneously to facilitate aligning the two images using obtaining an ultrasound scan.

  After the image is acquired and the desired invasive access site and vein are determined, this positional information is transmitted to the wearable electronic device 18 and anatomical positioning information obtained by processing the captured image. Used to determine the position relative to the virtual trace 62. The approximate location of the preferred vein and injection site is 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 further information to the technician. For example, vein diameter information may be projected next to each virtual vein trace 62 to assist the technician in selecting an appropriately sized vein and to select an appropriately sized catheter. it can. Similarly, different sized veins can be displayed in different colors to aid the selection process.

  Integrating data obtained by imaging devices such as ultrasound improves the selectivity, accuracy, and specificity of external visualization information projected to the technician. Thus, the technician can be confident that the displayed vein location is correct and that the dimension is appropriate for the type of vascular access device 60 used.

  The ultrasound image of the venous anatomy may be stored locally on the wearable electronic device 18 or transmitted to an external data device such as a patient database system for inclusion in a patient record. The ultrasound image can then be automatically provided for subsequent vascular access treatments to assist in venous selection.

  After the insertion is performed, the system 10e may be configured to acquire a real-time ultrasound image to confirm that the needle of the vascular access device 60 has been correctly placed in the vein. Similarly, the system 10e may record time and date stamps for insertion and include such information in patient records. System 10e can also record the position of the vessel insertion. This information can be used to prevent repeated insertions in the same region of the patient's body.

  In some further embodiments, the ultrasound monitor 64 may be configured to provide real-time information to the technician. For example, the user interface 110 of the wearable electronic device 18 may be configured to provide the technician's field of view 100 with real-time images obtained using the ultrasound monitor 64. In this way, the technician can also “gaze” the insertion process to ensure that the vascular access device 60 has been correctly inserted into the desired vein. Such real-time information allows the technician to correct for changes in anatomy and device position that may occur during the insertion process. Similarly, such a real-time system may be useful for assessing feasibility, location, and changes in the venous structure of the deployed vascular access device 60. Thus, the technician can better determine when the indwelling vascular access device 60 needs to be removed or repositioned.

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

  The invasive device of the system can also be composed of materials that can be magnetized for use in an ultrasound system, the ultrasound system utilizes magnetic functions to improve visualization, and the invasive device Provides a projection means in the form of a path when moving towards the target anatomy.

  Like the previously described system 10e, the user interface 110 projected onto the virtual layer 22 of the technician's field of view 100 provides important information regarding the procedure being performed, the device used, and the progress of the insertion process. It is advantageous to convey to a technician easily and without using a hand. Referring to FIG. 8, the overall user visual experience of the system 10e highlights the anatomy of the patient's blood vessels and provides the technician with an improved insertion success 100 (FIG. And having a virtual layer 22 projected on it). FIG. 9 is a schematic view of a virtual vein trace 62 that includes a portion of a patient's arm.

  Referring to FIG. 10, a further embodiment of a technician's field of view 100 that includes a virtual layer 22 projected onto a real layer 24 is shown. The virtual layer 22 includes a user interface 110 consisting of a header bar 112, which includes patient identification information and information regarding the procedure being performed. The user interface 110 also provides a warning portion 124 to the technician when the needle of the vascular access device 60 is in a vein or when the needle is stabbed, and the subcutaneous anatomy targeted by the invasive device. Including the projected trajectory of the invasive device during placement. User interface 110 also includes one or more schematic images 126 showing 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 the top view and shows the technician whether the needle needs to be moved left or right, forward or backward. Can do. User interface 110 may also include a second schematic image 126B depicting an elevation or side view showing 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 on the user interface 110. For example, the other view may include a cross-sectional view of the image shown in the first schematic image 126A or the second schematic image 126B. Alternatively, images obtained from out of plane, such as an ultrasound probe, can also be provided. Finally, the user interface 110 can include an icon 128 that indicates certain information about the vascular access device 60, such as the thickness or length of the catheter or needle.

  In use, the technician begins by determining what treatment should be performed and obtaining the necessary equipment. As in the previous embodiment of system 10e, the technician can determine this information by scanning patient ID 38. Based on the information obtained from the patient ID 38, the user interface 110 displays instructions regarding the procedure to be performed, instructions regarding what items need to be obtained, and any other relevant information regarding the procedure or patient. be able to. The technician then obtains the item for treatment, i.e. the vascular access device 60. The system 10e can verify that the correct item is obtained by scanning the identification tag 30 for each item. A warning can be displayed if the technician fails to obtain the required item.

  Prior to performing an infusion or vascular access procedure, a technician scans the desired insertion site using an imaging device wand 68 or scanner, such as an ultrasound monitor 64, and produces a subcutaneous three-dimensional image of the patient's vasculature. Can be acquired. System 10e can automatically process the resulting image and identify suitable veins for insertion of 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 size, shape, and orientation of the patient's arm, or other selected injection site The Based on these processing tasks, a vein trace, referred to herein as a virtual vein trace 62, is presented 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 placed.

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

  While specific embodiments of the present invention have been described in detail, those skilled in the art will appreciate that various modifications and alternatives to these details may be developed in view of the overall teachings of this disclosure. . Accordingly, the specific configurations disclosed are merely exemplary and are not meant as limitations on the scope of the invention, which is intended to be limited by the scope of the appended claims and any and The full breadth of all equivalent forms should be given. Further, while the present invention has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiment, such details are solely for that purpose. The invention is not limited to the disclosed embodiments, but on the contrary, includes modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. Please understand that it is intended. For example, it is understood that the present invention contemplates that, to the extent possible, one or more functions of any embodiment may be combined with one or more functions of any other embodiment. I want.

Claims (29)

A wearable electronic device configured to be worn by a user,
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;
Wearable electronic comprising: at least one imaging sensor; and at least one microprocessor for managing the data transmission interface; and a program for acquiring and processing an image acquired by the at least one imaging sensor The device,
A sampling device for collecting a liquid sample in a sample container;
A system comprising at least one identification tag attached to or integrally formed with said sampling device or sample container, comprising at least one identification tag comprising or associated with a tracking code;
The program processes an image captured by the at least one imaging sensor to identify the at least one identification tag and determine the tracking code;
The program sends confirmation that the sample has been acquired and the tracking code to the external electronic device via the data transmission interface;
Image capture, image processing, and data transmission are performed automatically without requiring input or manipulation by the user.   The system of claim 1, further comprising a data reporting accessory for providing data to the user.   The system according to claim 1, wherein image capturing, image processing, and data transmission are managed by the program without using a hand.   The system of claim 1, wherein the sampling device is a vascular access device, a phlebotomy set, a renal catheter, a tissue sampling device, or any combination thereof.   5. The system of claim 4, wherein the vascular access device is a peripheral IV catheter, a PICC line, or a central venous line.   3. The wearable electronic device is a head-mounted computer, and the data reporting accessory is a projection prism configured to project a virtual layer onto the user's field of view. The described system.   The system of claim 6, wherein the virtual layer includes a user interface, the user interface including a patient information portion, a sample collection confirmation portion, an identification tag confirmation portion, or any combination thereof.   The system of claim 1, wherein the at least one imaging sensor is a digital camera or a digital video camera.   The wearable electronic device further comprises a data storage medium for storing the program, sample collection confirmation, the tracking code for the sample container, or an image captured by the at least one imaging sensor. The system of claim 1.   The system of claim 1, wherein the wearable electronic device comprises a peripheral data input device that allows the user to manually enter data into the wearable electronic device.   The system of claim 10, wherein the peripheral data input device is a motion sensor, gyroscope, pressure sensor, accelerometer, touch pad, touch screen, or any combination thereof.   The system of claim 1, wherein the wearable electronic device further comprises a power supply within the housing of the wearable electronic device.   The system of claim 1, wherein the data transmission interface is configured to send data to and receive data from a patient data system.   Information received from the patient data system may include information regarding the procedure being performed, information regarding the type of fluid sampling device used, information regarding the amount of fluid sample required, information regarding suggested vascular access sites, or information regarding the patient. The system of claim 13, comprising:   Information sent to the external electronic device includes the confirmation that the sample was obtained, the time and date the sample was obtained, information about the location of the injection site, the tracking code for the sampling device, or their The system of claim 1, comprising any combination.   The at least one identification tag includes a two-dimensional barcode, a three-dimensional barcode, a near field communication device, or a label having text readable by an optical character recognition algorithm. The described system.   The program captures by processing the image to identify the position of a position marker on the sampling device and identifying the position of the at least one identification tag based on the position of the position marker. The system of claim 1, wherein the at least one identification tag in the captured image is identified.   The patient identification device further comprising or associated with patient identification information, wherein the patient identification device is readable by the at least one imaging sensor of the wearable electronic device. The system according to 1.   Receiving a portion of the fluid sample to inspect the fluid sample for one or more of the following: chemical, electrolyte, hematology, blood gas concentration, coagulation, or cardiac marker The system of claim 1, further comprising a point-of-care testing device configured as described above.   20. The point-of-care testing device is one or more of the following: test strip, dipstick, immunoassay, glass slide, or diagnostic cartridge. The system described in.   The program captures an image of the point-of-care test device after the point-of-care test device is exposed to a portion of the fluid sample, and the program processes the image of the point-of-care test device. 20. The system of claim 19, wherein the point of care test device results are determined.   The point-of-care testing device includes identification information about or associated with the point-of-care testing device, and the program processes an image of the point-of-care testing device to obtain the identification information. 20. The system of claim 19, wherein the system is determined.   The program confirms that the liquid sample has been collected by processing a series of images of the sample container captured by the at least one imaging sensor, so that a minimum amount of liquid is contained in the sample container. The system of claim 1, wherein the system determines when it exists.   24. The system of claim 23, wherein the wearable electronic device alerts the user when the minimum amount of liquid has been collected. A method for confirming and tracking an obtained liquid sample, comprising:
Collecting a liquid sample in a sample collection container of a sampling device;
Acquiring a series of images of the sample collection container using a wearable electronic device having at least one imaging sensor when the liquid sample is being collected;
Processing the series of images in real time to determine when a predetermined volume is present in the sample collection container;
Notifying a user wearing the wearable electronic device that sample collection is complete when an image showing the sample collection container filled with the predetermined liquid volume is acquired; and
The processing step is performed automatically without any operation by the user.   At least one of the series of images for identifying and extracting information about the sampling device or sample collection container from an identification tag attached to or integrally formed with the sampling device or sample collection container. 26. The method of claim 25, further comprising processing one.   27. The method of claim 26, wherein the information extracted from the identification tag includes a tracking code for the sampling device.   28. The method of claim 27, further comprising transmitting confirmation that a sample has been collected and the tracking code for the sampling device to an external source via a data transmission interface of the wearable electronic device. The method described.   26. The wearable electronic device is a head-mounted computer that includes a projection prism configured to project a virtual layer containing information and instructions onto the user's field of view. the method of.

Images