Fluid management and component detection system

• US 20040092885A1
• Filed: 08/08/2003
• Published: 05/13/2004
• Est. Priority Date: 04/04/2000
• Status: Active Grant

• Current Assignee: Douglas Duchon, James Ryan Mujwid, Robert F. Wilson
• Original Assignee: Douglas Duchon, James Ryan Mujwid, Robert F. Wilson
• Inventors: Wilson, Robert F., Duchon, Douglas, Mujwid, James Ryan
• Granted Patent: US 7,169,135 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• CPC Class Codes: A61M 2205/11 with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

Devices that detect and monitor components and fluid used with an injector system, such as an angiographic injector system, are disclosed. The devices may include mechanical, electrical or software based indexing or keying features to ensure that only compatible components are used on the system. In addition, these devices may also be used to track and/or monitor fluid volume and use during various injection procedures. Single use and multiple use components, conveniently supplied in kits, may also be tracked and/or monitored by the devices of the present invention.

Claims

1. An injector subassembly used with an injector system, said injector subassembly comprising:

a single use portion; and

a multiple use portion;

said single use portion fluidly connected to said multiple use portion, said single use portion including a high pressure tube connected to a catheter connection and said multiple use portion including a syringe connected to a fluid supply reservoir;

said syringe and said high pressure tube being in fluid communication at a predetermined period of operation.

2. The injector subassembly of claim 1 wherein said single use portion includes a three-way stop-cock connecting said high pressure tube to said catheter connection.

3. The injector subassembly of claim 2 wherein said three-way stop-cock includes a patient medication port.

4. The injector subassembly of claim 1 wherein a length of said high pressure tube is related to a pressure drop along said length.

5. The injector subassembly of claim 1 wherein said high pressure tube is made of PVC.

6. The injector subassembly of claim 1 wherein said single use portion includes a patient manifold that connects said syringe to said high pressure tube.

7. The injector subassembly of claim 6 wherein said patient manifold includes a spring biased spool valve which normally connects a pressure transducer to a patient port.

8. The injector subassembly of claim 6 wherein said single use portion includes a pressure transducer connected to said patient manifold.

9. The injector subassembly of claim 8 wherein said single use portion includes a saline subassembly attached to said pressure transducer.

10. The injector subassembly of claim 9 wherein said saline subassembly includes a saline check valve, saline tubing, saline spike and saline supply.

11. The injector subassembly of claim 1 wherein said multiple use portion includes a one-way valve connecting said syringe to said fluid supply reservoir.

12. The injector subassembly of claim 11 wherein said multiple use portion includes a fluid container spike connecting said one-way valve to said fluid supply reservoir.

13. The injector subassembly of claim 11 wherein said one-way valve includes a weighted ball that when seated in a lower position permits air to flow from said syringe body and when seated in an upper position prevents fluid from flowing from said syringe body to said fluid supply reservoir.

14. The injector subassembly of claim 1 wherein said multiple use portion can be reused up to approximately five times.

15. The injector subassembly of claim 1 wherein said multiple use portion can be reused on one or more patients without cleaning or sterilizing said multiple use portion between each use.

16. The injector subassembly of claim 1 wherein said single use portion is cleaned and sterilized after being used on said patient or case.

17. The injector subassembly of claim 16 wherein said single use portion is reused after said single use portion is cleaned and sterilized.

18. The injector subassembly of claim 1 wherein said syringe is transparent.

19. The injector subassembly of claim 1 wherein said syringe is made of polycarbonate.

20. The injector subassembly of claim 1 wherein said syringe repeatedly draws in fluid from said supply reservoir.

21. The injector subassembly of claim 1 wherein said single use portion is supplied to a user of said subassembly as a kit.

22. The injector subassembly of claim 1 wherein said multiple use portion is supplied to a user of said subassembly as a kit.

23. An injector system providing a continuous, contamination-free supply of fluid from a fluid reservoir through a syringe to a patient, said system comprising:

a syringe body including an upper port and a lower port;

a reservoir containing a volume of fluid;

a fluid container spike connecting said syringe to said reservoir;

a one-way valve located between said spike and said upper port of said syringe, said one-way valve including a weighted ball to control fluid flow; and

a check valve located between said lower port and said patient.

24. The injector system of claim 23 wherein said weighted ball is positioned at a lower seated position within said valve and is sufficiently heavy to prevent air to flow from said syringe body into said bottle without lifting said ball to an upper seated position.

25. The injector system of claim 24 wherein said fluid flows from said syringe body into said upper port after air is removed from said syringe body.

26. The injector system of claim 25 wherein a specific gravity of said fluid together with the hydrodynamic interaction of said weighted ball lift said ball to an upper seated position.

27. The injector system of claim 26 wherein said weighted ball in said upper seated position blocks a passageway from said upper port to said bottle so that said fluid cannot flow back from said syringe body into said bottle.

28. The injector system of claim 23 wherein said check valve prevents said syringe fluid from becoming contaminated.

29. A syringe for use in an angiographic injector system, said syringe comprising:

a syringe body having a distal end, a proximal end and a pumping chamber; and

a syringe plunger located in said pumping chamber and movable along a path from said distal end to said proximal end of said syringe body, said syringe plunger connected to and controlled by a user-interface subassembly whereby said syringe plunger automatically disconnects from said syringe body when said syringe body has been used for a maximum number of uses.

30. An angiographic injector system that tracks the volume of fluid injected by said system, said injector system comprising:

a user-interface subassembly;

a reservoir containing fluid used during an injection procedure;

a syringe fluidly connected to said reservoir and a patient, said syringe including a syringe plunger movable within said syringe; and

a syringe holder that holds said syringe in place on said injector system, said syringe holder including at least one electrical device that tracks the volume of fluid dispensed via movement of said syringe plunger.

31. The injector system of claim 30 wherein said electrical devices are sensors.

32. The injector system of claim 30 wherein said electrical devices are switches.

33. The injector system of claim 30 wherein software is used in combination with said electrical devices.

34. The injector system of claim 33 wherein said electrical devices include a memory or identification chip.

35. The injector system of claim 30 further comprising a bar-code reader that reads a bar-code on said reservoir.

36. The injector system of claim 35 wherein said bar-code reader contains reservoir size and volume information.

37. The injector system of claim 36 wherein said bar-code information is automatically processed by said system.

38. An injector subassembly used with an angiographic injector system, said injector subassembly comprising:

a syringe body including a mechanical indexing structure; and

a syringe holder including a mechanical indexing structure that complimentarily mates with said mechanical indexing features of said syringe body.

39. The injector subassembly of claim 38 wherein said mechanical indexing or keying features of said syringe body are ribs and flanges positioned on an exterior surface of an end wall of said syringe.

40. The injector subassembly of claim 38 wherein said mechanical indexing or keying features of said syringe holder are opposing notches and projections.

41. The injector subassembly of claim 38 wherein said mechanical indexing or keying features of said syringe body are notches and projections.

42. An injector subassembly used with an angiographic injector system, said injector subassembly comprising:

a syringe body including a bar-code locate on said syringe body; and

a syringe holder including a bar-code reader located on said syringe holder, wherein said bar-code reader reads said bar-code on said syringe body and sends a signal to said injector system indicating that a compatible syringe body is installed on said system.

43. The injector subassembly of claim 42 wherein said signal indicates that a single use syringe is installed on said system.

44. The injector subassembly of claim 42 wherein said signal indicates that a multiple use syringe is installed on said system.

45. An angiographic injector system comprising:

an injector subassembly; and

a user-interface subassembly wherein said user-interface subassembly includes a resume feature that allows a user of said system to stop a procedure, prior to its completion, and begin a new procedure.

46. The angiographic injector system of claim 45 wherein said resume feature powers down said system and returns said system to an initial start-up and display.

47. The angiographic injector system of claim 45 wherein said resume feature is in the form of a user-activated button.

48. The angiographic injector system of claim 45 wherein said resume feature is in the form of a user-activated switch.

49. A syringe for use in an angiographic injector system, said syringe comprising:

a syringe body having a distal end, a proximal end and a pumping chamber; and

a syringe plunger located in said pumping chamber and movable along a path from said distal end to said proximal end of said syringe body, said syringe plunger connected to and controlled by a user-interface subassembly whereby upon completion of a procedure via an “

End Case”

function, said system notifies an operator of a number of syringe uses so that said operator may either replace said syringe with a new, sterile syringe or continue using said syringe.

50. A syringe for use in an angiographic injector system, said syringe comprising:

a syringe body having a distal end, a proximal end and a pumping chamber; and

a syringe plunger located in said pumping chamber and movable along a path from said distal end to said proximal end of said syringe body, said syringe plunger connected to and controlled by a user-interface subassembly whereby upon completion of a procedure via an “

End Case”

function, said system notifies an operator of a number of syringe uses so that said operator replaces said syringe.