System and Method for Assuring Patient Medication and Fluid Delivery at the Clinical Point of Use

• US 20150209510A1
• Filed: 01/29/2015
• Published: 07/30/2015
• 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
• Granted Patent: US 10,188,791 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 confirmation of fluid delivery to a patient at the clinical point of use is provided. The system includes a wearable electronic device. The wearable electronic device has a housing; at least one imaging sensor associated with the housing; a data transmission interface; a data reporting accessory for providing data to the user; a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory; and a program for acquiring and processing images from the at least one imaging sensor. The system further includes a fluid delivery apparatus; and one or more identification tags attached to or integrally formed with the fluid delivery apparatus. The program processes an image captured by the at least one imaging sensor to identify the one or more identification tags and acquires fluid delivery apparatus information from the one or more identification tags.

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,

a data reporting accessory for providing data to the user,

a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory, and

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

a fluid delivery apparatus for passively or actively delivering a therapeutic agent to a patient; and

one or more identification tags attached to or integrally formed with the fluid delivery apparatus,

wherein the program processes an image captured by the at least one imaging sensor to identify the one or more identification tags and acquires fluid delivery apparatus information from the one or more identification tags.

2. The system of claim 1, wherein the program confirms completion of a fluid delivery procedure by processing the image captured by the at least one imaging sensor.

3. The system of claim 2, wherein the program reports the fluid delivery apparatus information and a confirmation of completion of the fluid delivery procedure to the user via the data reporting accessory or transmits the information and the confirmation to the external electronic device via the data transmission interface.

4. The system of claim 1, wherein the program acquires and processes images automatically to acquire information from the one or more identification tags and to confirm completion of the fluid delivery procedure.

5. The system of claim 1, wherein the data reporting accessory provides information to the user in a hands-free manner.

6. The system of claim 1, 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.

7. The system of claim 6, wherein the virtual layer includes a user interface, the user interface comprising a patient information portion, a dose confirmation portion, an identification tag confirmation portion, a fluid delivery apparatus volume indicator, or any combination thereof.

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 program confirms completion of a fluid delivery procedure by processing a series of images of the fluid delivery apparatus acquired by the at least one imaging sensor to track movement of a movable portion of the fluid delivery apparatus from an initial position to a final position.

10. The system of claim 9, wherein the movable portion of the fluid delivery apparatus is a plunger or piston rod movable through a body of the fluid delivery apparatus.

11. The system of claim 9, wherein the movable portion is coated with a substance that enhances the visibility of the movable portion in the series of images captured by the at least one imaging sensor to improve the tracking of the movement of the movable portion.

12. The system of claim 1, wherein the fluid delivery apparatus comprises one or more sensors configured to determine when a portion of the fluid delivery apparatus is inserted into a patient or to determine when fluid is expelled from the fluid delivery apparatus.

13. The system of claim 12, wherein the one or more sensors are directly or indirectly connected to the wearable electronic device, and wherein data collected by the one or more sensors is provided to the user via the data reporting accessory or transmitted to the external electronic device via the data transmission interface.

14. The system of claim 1, wherein the wearable electronic device further comprises a data storage medium for storing the program, the fluid delivery apparatus information, confirmation of completion of a fluid delivery procedure, or images captured by the at least one imaging sensor.

15. 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.

16. The system of claim 15, wherein the peripheral data entry device is a motion sensor, gyroscope, pressure sensor, accelerometer, touchpad, touchscreen, or any combination thereof.

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

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

19. The system of claim 18, wherein information received from the patient data system includes information about a procedure to be performed, information about the fluid delivery apparatus required for the procedure, or information about the patient.

20. The system of claim 1, wherein information transmitted to the external electronic device includes confirmation of completion of a fluid delivery procedure, a time and date of the procedure, a fluid injection volume of the procedure, a quality or type of fluid injected during the procedure, or any combination thereof.

21. The system of claim 1, wherein the fluid delivery apparatus is one or more of the following:

a pre-filled syringe, a pen injector, an auto-injector, an infusion set, a catheter, a vascular access device, or any combination thereof.

22. The system of claim 1, wherein the one or more identification tags comprise 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.

23. The system of claim 1, wherein the program identifies the one or more identification tags in the image captured by processing the image to locate a positional marker on the fluid delivery apparatus and then locating the one or more identification tags based on the location on the image of the positional marker.

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

25. A system comprising:

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

a housing,

at least one sensor associated with the housing,

a data transmission interface for sending data to or receiving data from an external electronic device,

a data reporting accessory for providing information to the user,

a microprocessor for managing the at least one sensor, the data transmission interface, and the data reporting accessory, and

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

a fluid delivery apparatus for passively or actively delivering a therapeutic agent to a patient;

one or more identification tags attached to or integrally formed with the fluid delivery apparatus; and

a patient identification device including or associated with identifying information about the patient and readable by the at least one sensor.

26. The system of claim 25, wherein the program manages acquiring information from the one or more identification tags and patient identification device.

27. The system of claim 26, wherein the program determines whether the fluid delivery apparatus is sufficient for a fluid delivery procedure based on information acquired from the one or more identification tags and patient identification device.

28. The system of claim 27, wherein the data reporting accessory provides an alert to the user if the fluid delivery apparatus is not sufficient for the fluid delivery procedure.

29. The system of claim 25, wherein the patient identification device comprises locating circuitry for determining a location of the patient.

30. A system comprising:

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

a housing,

at least one imaging sensor enclosed within or associated with the housing,

a data transmission interface for sending data to or receiving data from an external electronic device,

a data reporting accessory for providing information to the user,

a microprocessor for managing the at least one imaging sensor, the data transmission interface, and the data reporting accessory, and

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

an infusion set for delivering one or more therapeutic agents from a fluid container to a patient via a vascular access device,

wherein the program determines a fluid flow rate for fluid being expelled from the fluid container by processing a series of images captured by the at least one imaging sensor to determine fluid flow from the fluid container.

31. The system of claim 30, wherein the program verifies that the infusion set is correctly connected by identifying connection points between portions of the infusion set on an image of the infusion set captured by the at least one imaging sensor and processes a portion of the image including the connection points to determine whether a sufficient connection exists.

32. The system of claim 31, wherein the data reporting accessory alerts the user when the program determines that a connection is not sufficient.

33. A method for confirming fluid delivery to a patient at a clinical point of use, the method comprising:

actuating a fluid delivery apparatus by advancing a movable portion of the fluid delivery apparatus through a body of the fluid delivery apparatus to expel fluid therefrom;

acquiring a series of images of the fluid delivery apparatus, as the movable portion is being advanced through the body, with a wearable electronic device having at least one imaging sensor;

processing the series of images in real time to determine if the movable portion of the fluid delivery apparatus has advanced to an end-of-use position; and

informing a user wearing the wearable electronic device that the fluid delivery is complete when an image showing the movable portion of the fluid delivery apparatus in the end-of-use position is acquired,

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

34. The method of claim 33, wherein processing the series of images is performed using a computer of the wearable electronic device, a virtual computer, an external dedicated electronic device wired or wirelessly connected to the wearable electronic device, or an external computer connected to the wearable electronic device via a data transmission interface.

35. The method of claim 33, further comprising processing at least one of the series of images to identify and extract information about the fluid delivery apparatus from an identification tag affixed to or integrally formed with the fluid delivery apparatus.

36. The method of claim 33, wherein the fluid delivery apparatus is a syringe and wherein the movable portion is a plunger that is advanced through a body of the syringe from an initial position at a proximal end of the body to the end-of-use position at a distal end of the body.