Fluid injection and safety system

• US 9,632,013 B2
• Filed: 09/14/2012
• Issued: 04/25/2017
• Est. Priority Date: 05/18/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rivas, Gil, Butler, Michael, Chiou, Jeffrey T., Lim, Eugene
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US13/619,432
• Publication Number:
  US 20130160532A1
• Time in Patent Office: 1,684 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 39/02 : Access sites
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 1/10 : in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G16B 99/00 : Subject matter not provided for in other groups of this subclass
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/144444 : Glucose

Abstract

Various medical systems and methods are described, including a medical monitoring system. The medical monitoring system can have a fluid system configured to receive bodily fluid and optically analyze said fluid to determine analyte concentration. The fluid system can have a removable portion. The removable portion can have an opening with a port. The system can also have a container configured to contain anticoagulant. The container can have a portion configured to mate with the port of the removable portion. The container can be further configured to not fit into a conventional luer fitting. An anti-coagulant insertion apparatus is also described. The apparatus can have a syringe, a dock with a port, and an adapter configured to connect the syringe to the port. The dock can also have a tab configured to move with the port.

Claims

1. A medical device and automated setup instruction system comprising:

a fluid system comprising;

a non-disposable subsystem including at least one of a valve, a sensor or a pump;

a first disposable subsystem including at least one of a tube, a fitting or a waste bladder; and

a second disposable subsystem including a disposable cartridge configured to hold and prepare a sample of bodily fluid for analysis;

a display configured to be visible to a medical device user when the user is preparing the medical device for use in a medical setting;

a computer memory configured to store setup information and protocols that are specific to the medical device;

an input module configured to receive input relating to device setup, the input module comprising;

one or more sensors configured to detect configuration of components of the medical device and/or data regarding the environment in which the device is used;

one or more direct user input portions configured to accept input from the user relating to user-participation aspects of the device setup protocols; and

an automatic in-service medical device setup controller configured to access the computer memory according to the stored protocols and provide, on the display, sequential instructions to the medical device user to setup and/or use the device, wherein the setup controller determines based on input received from the input module to display a portion of the setup information stored on the computer memory,

wherein the automatic in-service medical device setup controller is configured to provide instructions directed towards at least one of;

attaching the medical device to a source of bodily fluid, loading the second disposable subsystem into the medical device, priming the second disposable subsystem with saline, selecting medical device settings determining operating conditions of the medical device or selecting different alarm settings.

2. The system of claim 1, wherein the setup controller is configured to provide the sequential instructions to the user in real-time.

3. The system of claim 1, wherein the setup controller is configured to provide setup instructions sequentially to the user.

4. The system of claim 1, wherein the setup controller is configured to provide setup instructions to the user by displaying text and/or graphics on the display.

5. The system of claim 1, wherein the user input comprises an answer to a query displayed to the user on the display or a command to continue to provide the next set of instructions on the display.

6. The system of claim 1, wherein the user input comprises a password, a code or a security information.

7. The system of claim 1, wherein the setup controller is configured to prompt the user to take one or more actions based on the input received from the input module related to the status of the medical device.

8. The system of claim 7, wherein the setup controller is configured to provide audio or visual prompts.

9. The system of claim 1, wherein the setup controller is configured to display a status of the medical device based on the input received from the input module.

10. The system of claim 1, further comprising an analyte monitoring system configured to determine concentration of an analyte in the sample of bodily fluid, wherein the analyte is glucose.

11. The system of claim 10, wherein the setup controller is configured to provide a signal to the analyte monitoring system to begin monitoring a patient upon completion of the setup.

12. The system of claim 1, further comprising a fluid controller configured to:

withdraw bodily fluid from the source of bodily fluid using the fluid system;

obtain the sample of bodily fluid from the withdrawn bodily fluid using the non-disposable subsystem;

direct the sample of bodily fluid through the first disposable subsystem towards the second disposable subsystem; and

direct the sample of bodily fluid from the second disposable subsystem towards an element of the first disposable system after analysis.

13. The system of claim 1, wherein the first disposable subsystem is fluidically connected to the second disposable subsystem.