System and method for collection confirmation and sample tracking at the clinical point of use

• US 9,832,412 B2
• Filed: 01/29/2015
• Issued: 11/28/2017
• Est. Priority Date: 01/29/2014
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Burkholz, Jonathan Karl, O'Bryan, Jeff
• Primary Examiner(s): Henson, Devin
• Application Number:
  US14/608,434
• Publication Number:
  US 20150209114A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150847 Communication to or from blood sampling device transmitting measured data A61B5/0002
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/6009 : for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6027 : Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 : Optical identification systems
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/28 : Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/315 : Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/427 : Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: G02B 2027/0138 : comprising image capture systems, e.g. camera
• CPC Class Codes: G02B 2027/0141 : characterised by the informative content of the display
• CPC Class Codes: G02B 27/017 : Head mounted
• CPC Class Codes: G06F 3/011 : Arrangements for interaction with the human body, e.g. for user immersion in virtual reality blind teaching G09B21/00
• CPC Class Codes: G06Q 50/22 : Social work or social welfare, e.g. community support activities or counselling services
• CPC Class Codes: G06V 20/20 : in augmented reality scenes
• CPC Class Codes: G06V 20/52 : Surveillance or monitoring of activities, e.g. for recognising suspicious objects recognising microscopic objects G06V20/69
• CPC Class Codes: G06V 2201/03 : Recognition of patterns in medical or anatomical images
• CPC Class Codes: G06V 2201/034 : of medical instruments
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 10/65 : stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 30/40 : for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H04N 23/51 : Housings
• CPC Class Codes: H04N 23/57 : Mechanical or electrical details of cameras or camera modules specially adapted for being embedded in other devices
• CPC Class Codes: H04N 5/44 : Receiver circuitry for the reception of television signals according to analogue transmission standards H04N5/14 takes precedence
• CPC Class Codes: H04N 7/18 : Closed-circuit television [CCTV] systems, i.e. systems in which the video signal is not broadcast
• CPC Class Codes: H04N 7/185 : from a mobile camera, e.g. for remote control

Abstract

A system for confirming acquisition of a fluid sample is provided. The system includes a wearable electronic device configured to be worn by a user. The device has 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, a microprocessor for managing the at least one imaging sensor and 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 a fluid sample in a 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.

Claims

1. A system comprising:

a wearable electronic device configured to be worn by a user comprising;

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;

at least one microprocessor for managing the at least one imaging sensor and the data transmission interface; and

a program for acquiring and processing images acquired by the at least one imaging sensor;

a sampling device for collecting a fluid sample in a 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 including or being associated with a tracking code,

wherein the program processes an image captured by the at least one imaging sensor to identify the at least one identification tag and to determine the tracking code,

wherein the program transmits a confirmation that a sample was acquired, and the tracking code, to the external electronic device via the data transmission interface,

wherein image capture, image processing, and data transmission are performed automatically without an input or actuation activity by the user, and

wherein the program identifies the at least one identification tag in the image captured by processing the image to locate a positional marker on the sampling device and locating the at least one identification tag based on the position of the positional marker, wherein the positional marker points to the at least one identification tag and triggers the wearable electronic device to begin the image processing of the at least one identification tag,

wherein, after locating the positional marker by processing the image, the program delays the image processing of the at least one identification tag until the positional marker on the sampling device has been within a field of view of the at least one imaging sensor for a predetermined period of time.

2. The system of claim 1, further comprising a data reporting accessory for providing data to the user.

3. The system of claim 2, wherein the wearable electronic device is a head-worn computer, and wherein the data reporting accessory is a projection prism configured to project a virtual layer to a field of view of the user.

4. The system of claim 3, wherein the virtual layer includes a user interface, the user interface comprising a patient information portion, a sample collection confirmation portion, an identification tag confirmation portion, or any combination thereof.

5. The system of claim 1, wherein image capture, image processing, and data transmission are managed by the program in a hands-free manner.

6. The system of claim 1, wherein the sampling device is a vascular access device, phlebotomy set, renal catheter, tissue sampling device, or any combination thereof.

7. The system of claim 6, wherein the vascular access device is a peripheral IV catheter, a PICC line, or a central line.

8. The system of claim 1, wherein the at least one imaging sensor is a digital camera or digital video camera.

9. The system of claim 1, wherein the wearable electronic device further comprises a data storage medium for storing the program, a sample collection confirmation, the tracking code for the sample container, or images captured by the at least one imaging sensor.

10. The system of claim 1, wherein the wearable electronic device includes a peripheral data entry device that allows the user to manually enter data to the wearable electronic device.

11. The system of claim 10, wherein the peripheral data entry device is a motion sensor, gyroscope, pressure sensor, accelerometer, touchpad, touchscreen, or any combination thereof.

12. The system of claim 1, wherein the wearable electronic device further comprises a power supply within the housing of the wearable electronic device.

13. The system of claim 1, wherein the data transmission interface is configured to send data to and receive data from a patient data system.

14. The system of claim 13, wherein information received from the patient data system includes information about a procedure to be performed, information about a type of fluid sampling device to use, information about a volume of fluid sample required, information about a suggested vascular access site, or information about a patient.

15. The system of claim 1, wherein information transmitted to the external electronic device includes the confirmation that the sample was obtained, a time and date that the sample was obtained, information about a location of an injection site, the tracking code for the sampling device, or any combination thereof.

16. The system of claim 1, wherein the at least one identification tag comprises a two-dimensional bar code, a three-dimensional bar code, a near field communication device, or a label having text readable by an optical character recognition algorithm.

17. The system of claim 1, further comprising a patient identification device including or associated with identifying information about a patient, the patient identification device being readable by the at least one imaging sensor of the wearable electronic device.

18. The system of claim 1, further comprising a point-of-care testing device configured to receive a portion of the fluid sample for testing the fluid sample for one or more of the following:

chemicals, electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers.

19. The system of claim 18, wherein the point-of-care testing device is one or more of the following:

a test strip, dip stick, immunoassay, glass slide, or diagnostic cartridge.

20. The system of claim 18, wherein the program captures an image of the point-of-care testing device after the point of care testing device is exposed to a portion of the fluid sample, and wherein the program processes the image of the point-of-care testing device to determine a result of the point-of-care testing device.

21. The system of claim 18, wherein the point-of-care testing device includes an identification tag including or associated with identifying information for the point-of-care testing device, and wherein the program processes an image of the point-of-care testing device to determine the identifying information.

22. The system of claim 1, wherein the program confirms that the fluid sample has been collected by processing a series of images of the sample container captured by the at least one imaging sensor to determine when a minimum fluid volume is present in the sample container.

23. The system of claim 22, wherein the wearable electronic device alerts the user when the minimum fluid volume is collected.

24. A method for confirming and tracking an acquired fluid sample, the method comprising:

collecting a fluid sample in a sample collection container of a sampling device;

acquiring a series of images of the sample collection container, as the fluid sample is being collected, with a wearable electronic device having at least one imaging sensor;

processing the series of images in real time to determine when a predetermined fluid volume is present in the sample collection container;

informing a user wearing the wearable electronic device that sample collection is complete when an image showing the sample collection container filled with the predetermined volume of fluid is acquired; and

processing at least one of the series of images to identify and extract information about the sampling device or sample collection container from at least one identification tag affixed to or integrally formed with the sampling device or sample collection container,

wherein processing is performed automatically without an actuation activity by the user,

wherein the processing identifies and extracts the information about the sampling device or sample collection container from the at least one identification tag in the at least one of the series of images by processing the at least one of the series of images to locate a positional marker on the sampling device or sample collection container and locating the at least one identification tag based on the position of the positional marker, wherein the positional marker points to the at least one identification tag and triggers the wearable electronic device to begin processing of the at least one identification tag to identify and extract the information about the sampling device or sample collection container,

wherein, after locating the positional marker by processing the at least one of the series of images, the processing to identify and extract the information about the sampling device or sample collection container from the at least one identification tag in the at least one of the series of images is delayed until the positional marker on the sampling device or sample collection container has been within a field of view captured by the series of images for a predetermined period of time.

25. The method of claim 24, wherein the information extracted from the identification tag includes a tracking code for the sampling device.

26. The method of claim 25, further comprising transmitting a confirmation that a sample was collected, and the tracking code for the sampling device, to an external source via a data transmission interface of the wearable electronic device.

27. The method of claim 24, wherein the wearable electronic device is a head-worn computer including a projection prism configured to project a virtual layer including information and instructions to a field of view of the user.