INJECTION SYSTEM HAVING READABLE INFORMATION STORES AND METHOD FOR CONTROLLING THE OPERATION THEREOF

• US 20080071219A1
• Filed: 11/21/2007
• Published: 03/20/2008
• Est. Priority Date: 03/04/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Reilly, David, Rhinehart, Edward, Hack, Dennis, Kalafut, John
• Granted Patent: US 7,905,861 B2
• Time in Patent Office: Days
• US Class Current: 604/152
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1422 with double acting or multiple pistons
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

An injection system includes a fluid delivery system, a drive mechanism, a controller and a tubing set. The fluid delivery system includes a fluid container and a pumping mechanism having an inlet in fluid connection with the fluid container and an outlet. The tubing set is adapted to be placed in removable fluid connection with the outlet of the pumping mechanism and a patient. The drive mechanism is in operative connection with the pumping mechanism to pump fluid from the fluid container. First and second information stores, such as bar codes or RFID tags, are associated with the pumping mechanism and the tubing set, respectively. The controller is in operative connection with the drive mechanism and adapted to read the first information store and the second information store to at least partly control the operation of the drive mechanism based thereon.

Claims

1. An injection system, comprising:

a fluid delivery system comprising a fluid container and a pumping mechanism having an inlet in fluid connection with the fluid container and an outlet having a connector;

at least one tubing set adapted to be placed in removable fluid connection with the outlet of the pumping mechanism and a patient, the at least one tubing set comprising a mating connector adapted to be connected to the connector on the outlet of the pumping mechanism;

a drive mechanism in operative connection with the pumping mechanism to pump fluid from the fluid container;

a first information store associated with the pumping mechanism and providing at least configuration information relating thereto;

a second information store associated with the at least one tubing set and providing configuration information relating thereto; and

a controller in operative connection with the drive mechanism and adapted to read the first information store and the second information store to at least partly control the operation of the drive mechanism based thereon.

2. The injection system of claim 1 wherein the controller is adapted to note when the pumping mechanism is connected to the drive mechanism and to countdown a predetermined time period during which the fluid in the fluid container must be injected into one or more patients.

3. The injection system of claim 2 wherein the controller is adapted to provide an alert or to prevent fluid flow after the predetermined time period has elapsed.

4. The injection system of claim 1 wherein the configuration information provided by the second information store includes the volume of the at least one tubing set.

5. The injection system of claim 4 wherein the volume information enables the controller to control a priming function in which the pumping mechanism and the at least one tubing set are primed with fluid from the fluid container.

6. The injection system of claim 1, further comprising a third information store associated with the fluid container and providing information relating thereto, and further wherein the controller is adapted to read the third information store to at least partly control the operation of the drive mechanism based thereon.

7. The injection system of claim 6 wherein the information provided by the third information store includes one or more of fluid volume, fluid identity and concentration.

8. The injection system of claim 6 wherein the third information store is a bar code or an RFID tag.

9. The injection system of claim 1 wherein the first information store is a bar code or an RFID tag and the second information store is a bar code or an RFID tag.

10. The injection system of claim 1 wherein the pumping mechanism is in permanent or non-removable fluid connection with the fluid container.

11. The injection system of claim 1, further comprising a tube in fluid connection between the pumping mechanism and the inlet of the fluid container to place the pumping mechanism in fluid connection with the fluid container.

12. The injection system of claim 1 wherein the fluid container contains sufficient fluid for multiple patients and the at least one tubing set comprises a plurality of tubing sets, and further wherein a different tubing set is connected to the connector of the outlet of the pumping mechanism for each of the multiple patients.

13. The injection system of claim 12 wherein the connector of the outlet and the mating connector of the at least one tubing set form an aseptic connection.

14. The injection system of claim 13 wherein the connector comprises a swabable valve.

15. The injection system of claim 12 wherein the at least one tubing set further comprises a valve to prevent fluid flow from the patient toward the mating connector.

16. The injection system of claim 1 wherein the pumping mechanism further comprises at least one pressurizing chamber in fluid connection with the inlet and the outlet and the drive mechanism comprises at least one drive member, and further wherein the at least one pressurizing chamber is adapted to be placed in operative, removable connection with the at least one drive member to pump fluid from the container.

17. The injection system of claim 16 wherein the at least one pressurizing chamber comprises a plurality of pressurizing chambers and the at least one drive member comprises a plurality of drive members.

18. The injection system of claim 16 wherein the at least one pressurizing chamber is formed from a flexible, resilient material that can be compressed by the at least one drive member to pressurize fluid within the at least one pressurizing chamber.

19. The injection system of claim 18 wherein the flexible material of the at least one pressurizing chamber is suitably resilient such that recovery of the flexible material of the at least one pressurizing chamber creates a pressure difference between the at least one pressurizing chamber and the fluid container suitable to draw fluid from the fluid container into the at least one pressurizing chamber.

20. The injection system of claim 16 wherein the at least one pressurizing chamber comprises a piston slidably disposed therein and the at least one drive member is in operative, removable connection with the piston.

21. The injection system of claim 16, further comprising:

at least one first valve disposed in the at least one pressurizing chamber between the fluid container and the outlet, the at least one first valve adapted to allow flow from the fluid container into the at least one pressurizing chamber but to prevent flow from the at least one pressurizing chamber into the fluid container; and

at least one second valve disposed in the at least one pressurizing chamber between the at least one first valve and the outlet, the at least one second valve adapted to allow flow from the at least one pressurizing chamber into the outlet but to prevent flow from the outlet into the at least one pressurizing chamber.

22. The injection system of claim 1 wherein the pumping mechanism is discarded after use with a predetermined number of patients.

23. The injection system of claim 1 wherein the at least one tubing set further comprises a port and a valve in fluid connection with the port to prevent fluid from exiting the port when the at least one tubing set is under fluid pressure during an injection.

24. The injection system of claim 1, further comprising:

a second fluid delivery system comprising a second fluid container and a second pumping mechanism in fluid connection with the second fluid container and an outlet; and

a second drive mechanism in operative connection with the controller and the second pumping mechanism to pump fluid from the second fluid container;

wherein the at least one tubing set is further adapted to be placed in removable fluid connection with the outlet of the second pumping mechanism to deliver fluid from the fluid container and the second fluid container to the patient.

25. The injection system of claim 1, further comprising:

a second fluid container in fluid connection with the inlet of the pumping mechanism; and

a control valve associated with the inlet of the pumping mechanism, the control valve adapted to control the amount of fluid from the fluid container and the second fluid container that is injected into the patient.

26. A method of controlling the operation of an injection system comprising a drive mechanism and a controller in operative connection with the drive mechanism, the method comprising:

providing a fluid delivery system comprising;

a fluid container;

a pumping mechanism having an inlet in fluid connection with the fluid container and an outlet; and

one or more delivery set information stores providing at least configuration information relating to the fluid delivery system;

removably connecting the pumping mechanism to the drive mechanism;

reading the configuration information provided by the one or more delivery set information stores;

providing at least one tubing set having a tubing set information store providing tubing set configuration information;

removably connecting the at least one tubing set to the outlet of the pumping mechanism;

reading the tubing set configuration information provided by the tubing set information store; and

controlling the operation of the injection system based at least in part on the configuration information and the tubing set configuration information.

27. The method of claim 26 wherein the controller is adapted to read the one or more delivery set information stores and the tubing set information store.

28. The method of claim 26 wherein the one or more delivery set information stores are bar codes or RFID tags and the delivery set information store is a bar code or an RFID tag.

29. The method of claim 26 wherein the one or more delivery set information stores comprises two delivery set information stores, ands further wherein one of the two delivery set information stores is associated with the fluid container and the other of the two delivery set information stores is associated with the pumping mechanism.

30. The method of claim 27, further comprising:

noting when the pumping mechanism is connected to the drive mechanism; and

counting down a predetermined time period during which the fluid in the fluid container must be injected into one or more patients.

31. The method of claim 30, further comprising:

issuing an alert or preventing fluid flow after the predetermined time period has elapsed.

32. The method of claim 27 wherein the tubing set configuration information provided by the tubing set information store includes the volume of the at least one tubing set.

33. The method of claim 32, further comprising:

based on the volume of the at least one tubing set, controlling a priming function in which the pumping mechanism and the at least one tubing set are primed with fluid from the fluid container.

34. The method of claim 27 wherein the configuration information provided by the delivery set information store includes one or more of fluid volume, fluid identity and concentration.

35. The method of claim 27, further comprising:

discarding the pumping mechanism after use with a predetermined number of patients.

36. The method of claim 26 wherein the at least one tubing set comprises a plurality of tubing sets.