FLUID INJECTION AND SAFETY SYSTEM

• US 20090036764A1
• Filed: 05/19/2008
• Published: 02/05/2009
• Est. Priority Date: 05/18/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Lim, Eugene, Butler, Michael, Rivas, Gil, Chiou, Jeffrey T.
• Granted Patent: US 8,470,241 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 monitoring system comprising:

a fluid system configured to receive bodily fluid and optically analyze said fluid to determine analyte concentration, said fluid system having a removable portion;

an opening in said removable portion having a safety port; and

a container configured to contain anticoagulant, the container having a portion configured to mate with said safety port, the container further configured to not accommodate a connection with a conventional luer fitting configured to improve safety by preventing a user from introducing anticoagulant into any other ports having conventional luer fittings.

2. The medical monitoring system of claim 1, wherein the fluid system is configured to receive blood.

3. The medical monitoring system of claim 2, wherein the fluid system is further configured to determine glucose concentration in the blood.

4. The medical monitoring system of claim 1, wherein the removable portion comprises a disposable cartridge.

5. The medical monitoring system of claim 1, wherein the container is a syringe.

6. The medical monitoring system of claim 1, further comprising an adapter configured to connect to the container.

7. The medical monitoring system of claim 6, further comprising an anticoagulant holder, wherein the adapter is further configured to connect the container to the anticoagulant holder.

8. The medical monitoring system of claim 7, wherein the anticoagulant holder is a vial.

9. The medical monitoring system of claim 1, wherein the container is a disposable syringe body.

10. The medical monitoring system of claim 1, wherein the removable portion has an opening sized to receive the container.

11. The medical monitoring system of claim 1, wherein the port comprises a dock.

12. The medical monitoring system of claim 11, wherein the dock and container are configured to connect securely.

13. The medical monitoring system of claim 11, wherein the dock further comprises a tab having a first position and a second position, the tab further configured to prevent the removable portion from inserting into the medical monitoring system when the tab is in the first position.

14. The medical monitoring system of claim 13, wherein the tab is configured to be in the second position when the container is in a receptacle in the removable portion.

15. An anti-coagulant insertion apparatus comprising:

a syringe configured to hold medical fluid, the syringe having a tip;

a dock having a movable port configured to receive the tip of the syringe, the syringe and port configured to move together from a primary position to a secondary position; and

a tab on the dock configured to move with a portion of the port as the syringe is moved, the tab preventing insertion of the dock into a medical device unless the syringe is in the secondary position.

16. The apparatus of claim 15, wherein the syringe has a collar and the dock has a groove, the collar configured to fit into the groove.

17. The apparatus of claim 16, wherein the dock is configured not to allow the syringe to move the port unless the collar fits into the groove, securing the syringe to the dock.

18. The apparatus of claim 15, wherein the movable port is rotatable.

19. A method of introducing fluid into a removable portion of a medical device, the method comprising:

providing an adapter on a syringe;

providing a fluid container;

attaching the adapter to the container;

withdrawing fluid from the container into the syringe;

separating the syringe from the adapter and exposing an end of the adapter having a special shape that prevents connection to a conventional luer fitting;

allowing the adapter to remain connected to the container to prevent use of container contents except through an implement having the shape of the adapter;

inserting a portion of the syringe into a corresponding portion of a removable portion of a medical device; and

expelling fluid from the syringe into the removable portion of the medical device.

20. The method of claim 19, wherein providing a fluid container comprises providing a Heparin vial.

21. The method of claim 19, wherein providing an adapter on a syringe further comprises providing a sterilized adapter-syringe combination.

22. The method of claim 19, wherein inserting a portion of the syringe into a corresponding portion of a removable portion of a medical device comprises docking the syringe with a dock in a disposable cartridge.

23. The method of claim 19, further comprising:

securing the syringe to the removeable portion of the medical device before expelling fluid from the syringe into the removable portion of the medical device.

24. A medical fluid adapter apparatus comprising:

a first member configured to mate with and retain a medical fluid holder;

a second member connected to the first member, the second member being configured to receive a container;

the first and second members defining one or more passageways configured to allow fluid to flow between the container and the medical fluid holder, and at least the first member or the second member is not a conventional medical fitting and is configured to prevent connection with a conventional medical fitting.

25. The apparatus of claim 24, wherein the first member is a female connection member and the second member is a female connection member.

26. The apparatus of claim 24, further comprising one or more tabs extending from the first member, the tabs being configured to connect to the medical fluid holder.

27. The apparatus of claim 26, wherein the tabs comprise a first portion extending from the first member and a second portion extending from the first portion, wherein a cross-sectional area of the first portion is less than a cross-sectional area of the second portion.

28. The apparatus of claim 26, wherein the tabs extend at an angle relative to a longitudinal axis of the adapter apparatus.

29. The apparatus of claim 24, wherein the second member comprises at least one surface protruding at an angle relative to a longitudinal axis of the adapter apparatus.

30. The apparatus of claim 24, further comprising one or more tabs extending from the second member configured to connect to the container.

31. The apparatus of claim 24, wherein the medical fluid holder is a heparin vial.

32. An anti-coagulant insertion apparatus comprising:

a syringe; and

an adapter configured to connect to the syringe, wherein the adapter comprises one or more tabs that are configured to engage a portion of an anti-coagulant holder, the tabs further configured to deter disconnection of the anti-coagulant holder from the adapter.

33. The apparatus of claim 32, wherein the tabs are configured to resiliently deform as the adapter is connected to the syringe.

34. The apparatus of claim 32, wherein the anti-coagulant container is a heparin vial.

35. The apparatus of claim 32, wherein the syringe is specifically configured to not fit into a conventional luer fitting.

36. The apparatus of claim 32, wherein the tabs are further configured to require more force to disconnect the anti-coagulant holder from the adapter than was required to connect the anti-coagulant holder to the adapter.

37. The apparatus of claim 32, wherein the tabs are further configured to require a large force to disconnect the anti-coagulant holder from the adapter.

38. The apparatus of claim 32, wherein the tabs are further configured to require a tool or machinery to disconnect the anti-coagulant holder from the adapter.

39. The apparatus of claim 32, wherein the tabs are further configured to require breaking the adapter or breaking the anti-coagulant holder to disconnect the anti-coagulant holder from the adapter.

40. The apparatus of claim 32, wherein the tabs are further configured to resiliently engage the anti-coagulant holder such that without being forced outward, the tabs will not allow removal of the anti-coagulant holder from the adapter without sufficient force being applied to break the tabs.

41. The apparatus of claim 32, wherein the adapter is configured such that when the adapter is connected to the anti-coagulant holder, conventional medical tools cannot connect to the adapter to access fluid in the anti-coagulant holder.

42. A method of safely using a medical fluid in an analyte monitoring system and preventing use of the medical fluid for extraneous purposes, the method comprising the steps of:

providing a medical fluid container;

transferring fluid from the medical fluid container to an intermediate fluid transfer container;

inserting the intermediate fluid transfer container into a port in an analyte monitoring system; and

preventing the intermediate fluid transfer container from connecting with other medical ports by providing a special portion of the intermediate fluid transfer container that deters connection to other medical ports, thereby encouraging the discarding of the intermediate fluid transfer container; and

preventing the medical fluid container from connecting with other medical ports by providing a special end that deters connection to other medical ports, thereby encouraging the discarding of the medical fluid container.

43. The method of claim 42, wherein the medical fluid container is a heparin vial.

44. The method of claim 42, wherein the intermediate fluid transfer container is a disposable syringe.

45. The method of claim 42, wherein the special portion of the intermediate fluid transfer container is an end having a special shape that deters connection to other medical ports.

46. (canceled)