Fluid management and component detection system

• US 7,169,135 B2
• Filed: 08/08/2003
• Issued: 01/30/2007
• Est. Priority Date: 04/04/2000
• Status: Expired due to Term

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Wilson, Robert F., Duchon, Douglas, Mujwid, James Ryan
• Primary Examiner(s): Williams; Catherine S.
• Application Number:
  US10/637,465
• Publication Number:
  US 20040092885A1
• Time in Patent Office: 1,271 Days
• Field of Search: 604/890.1, 604151-154, 604246-260, 604/500
• 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. A method of controlling a medical fluid injection apparatus, comprising:

a. providing an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. providing a multiple use first disposable subassembly for use with said fluid delivery mechanism;

c. counting the number of times said first disposable subassembly is used to deliver medical fluid;

d. notifying an operator of said fluid injection apparatus of the number times said first disposable subassembly has been used to deliver medical fluid;

e. allowing said operator to either replace said first disposable subassembly with a second disposable subassembly or to continue using said first disposable subassembly; and

f. providing an ‘

end case’

function whereby after an injection procedure, said operator terminates the procedure by providing an indication that will cause the medical fluid injection apparatus to count the procedure as one use of said first disposable subassembly.

2. The method of claim 1, including the step of notifying said operator of the maximum number of times said first disposable subassembly may be used to deliver medical fluid.

3. The method of claim 1, including the steps of:

a. prompting said operator to remove said first disposable subassembly; and

b. resetting to zero the count of the number of times said first disposable subassembly was used to deliver medical fluid when said first disposable subassembly is replaced with a second disposable subassembly.

4. The method of claim 3, including the step of requiring that said first disposable subassembly be removed from said injection apparatus when said first disposable subassembly has been used to deliver medical fluid a pre-determined number of times.

5. The method of claim 4, wherein the pre-determined number of times said first disposable subassembly may be used to deliver medical fluid is approximately 5.

6. The method of claim 1, including the steps of:

a. calculating an equivalent to one use of said first disposable subassembly from the number of times said disposable subassembly is operated by said injector assembly; and

b. incrementing the count of the number of times said first disposable subassembly is used to deliver medical fluid.

7. A method of controlling a medical fluid injection apparatus, comprising:

a. providing an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. providing a first disposable subassembly for use with said fluid delivery mechanism;

c. determining whether said first disposable subassembly is intended for single or multiple uses;

d. counting the number of times said first disposable subassembly is used to deliver medical fluid;

e. notifying an operator of said fluid injection apparatus of the number times said first disposable subassembly has been used to deliver medical fluid;

f. allowing said operator to either replace said first disposable subassembly with a second disposable subassembly or to continue using said first disposable subassembly; and

g. providing an ‘

end case’

function whereby after an injection procedure, said operator terminates the procedure by providing an indication that will cause the medical fluid injection apparatus to count the procedure as one use of said first disposable subassembly.

8. The method of claim 7, including the step of notifying said operator of a pre-determined maximum number of times said first disposable subassembly may be used to deliver medical fluid.

9. The method of claim 7, including the steps of:

a. prompting said operator to remove said first disposable subassembly; and

b. resetting to zero the count of the number of times said first disposable subassembly was used to deliver medical fluid when said first disposable subassembly is replaced with a second disposable subassembly.

10. The method of claim 9, including the step of requiring that said first disposable subassembly be removed from said injection apparatus when said first disposable subassembly has been used to deliver medical fluid a pre-determined number of times.

11. The method of claim 10, wherein the pre-determined number of times said first disposable subassembly may be used to deliver medical fluid is approximately 5.

12. The method of claim 7, including the steps of:

a. calculating an equivalent to one use of said first disposable subassembly from the number of times said disposable subassembly is operated by said injector assembly; and

b. incrementing the count of the number of times said first disposable subassembly is used to deliver medical fluid.

13. A method of controlling a medical fluid injection apparatus, comprising:

a. providing an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. providing a first disposable subassembly for use with said fluid delivery mechanism;

c. providing a ‘

resume’

feature whereby when said injection apparatus is stopped prior to completion of an injection procedure, the operator of said injection apparatus is allowed to continue using said injection apparatus at a later time without having to replace said first disposable subassembly; and

d. providing an ‘

end case’

function whereby after an injection procedure, said operator terminates the procedure by pressing a key which will cause the medical fluid injection apparatus to count the procedure as one use of the first disposable subassembly.

14. The method of claim 13, including the step of providing said injection apparatus with a ‘

restart’

feature whereby when said injection apparatus is stopped prior to completion of a said injection procedure, the operator is allowed to replace said disposable subassembly with a second disposable subassembly.

15. The method of claim 14, including the step of allowing said operator to choose between said ‘

resume’

or ‘

restart’

features after said injection apparatus has been stopped.

16. The method of claim 14, including the step of allowing only said ‘

restart’

feature to be chosen by said operator if said first disposable subassembly is a single use disposable subassembly.

17. The method of claim 13, wherein said ‘

resume’

feature further allows the operator of said injection apparatus to continue using said injection apparatus at a later time without requiring the operator to perform a standard initialization of said injection apparatus.

18. The method of claim 14, including the step of allowing said operator to choose between said ‘

resume’

or ‘

restart’

features after said injection apparatus has been stopped and said ‘

end case’

function was not performed prior to stopping said injection apparatus.

19. A medical fluid injection apparatus, said apparatus comprising:

a. an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. a multiple use first disposable subassembly for use with said fluid delivery mechanism;

c. a counting means for counting the number of times said first disposable subassembly is used to deliver medical fluid; and

d. a user interface configured to notify an operator of said fluid injection apparatus of the number of times said first disposable subassembly has been used to deliver medical fluid and to allow said operator to either replace said first disposable subassembly with a second disposable subassembly or to continue using said first disposable subassembly, and the user interface further configured to provide an ‘

end case’

function whereby after an injection procedure, said operator terminates the procedure by pressing a key which will cause the medical fluid injection apparatus to count the procedure as one use of the first disposable subassembly.

20. The medical fluid injection apparatus of claim 19 wherein said counting means is configured to calculate the number of times said first disposable subassembly is used to deliver medical fluid by tracking the movement of a plunger within a syringe portion of said first disposable subassembly.

21. The medical fluid injection apparatus of claim 19 wherein said counting means is configured to calculate the number of times said first disposable subassembly is used to deliver medical fluid by monitoring the number of turns of a motor portion of said fluid delivery mechanism.

22. The medical fluid injection apparatus of claim 19 wherein said counting means calculates the number of times said first disposable subassembly is used to deliver medical fluid by monitoring the number of times ‘

end case’

signals are entered into said user interface.

23. The medical fluid injection apparatus of claim 19 wherein said operator is informed via said user interface that a pre-determined number of patient uses of said first disposable subassembly has been reached.

24. The medical fluid injection apparatus of claim 19 wherein said counting means is configured to set to zero the count of the number of times said first disposable subassembly is used to deliver medical fluid when said first disposable subassembly is replaced with said second disposable subassembly.

25. The medical fluid injection apparatus of claim 19 wherein said apparatus is configured to require the operator to replace said first disposable subassembly with said second disposable subassembly after said first disposable subassembly has been used to deliver medical fluid a pre-determined number of times.

26. The medical fluid injection apparatus of claim 25 wherein after said first disposable subassembly has been used to deliver medical fluid a pre-determined number of times, said medical fluid injection apparatus is rendered incapable of injecting medical fluid until said first disposable subassembly is replaced with said second disposable subassembly.

27. A medical fluid injection apparatus, said apparatus comprising:

a. an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. a first disposable subassembly for use with said fluid delivery mechanism;

c. means for determining whether said first disposable subassembly is intended for single or multiple uses;

d. a counting means for counting the number of times said first disposable subassembly is used to deliver medical fluid; and

e. a user interface configured to notify an operator of said fluid injection apparatus of the number of times said first disposable subassembly has been used to deliver medical fluid and to allow said operator to either replace said first disposable subassembly with a second disposable subassembly or to continue using said first disposable subassembly, and the user interface further configured to provide an ‘

end case’

function whereby after an injection procedure, said operator terminates the procedure by pressing a key which will cause the medical fluid injection apparatus to count the procedure as one use of the first disposable subassembly.

28. A medical fluid injection apparatus, said apparatus comprising:

a. an injector assembly with a fluid delivery mechanism for injecting medical fluid;

b. a multiple use first disposable subassembly for use with said fluid delivery mechanism;

c. a counting means for counting the number of times said first disposable subassembly is used to deliver medical fluid;

d. wherein said medical fluid injection apparatus includes a ‘

resume’

feature whereby when said injection apparatus is stopped prior to completion of an injection procedure, an operator of said injection apparatus is allowed to continue using said injection apparatus at a later time without having to replace said first disposable subassembly; and

e. wherein said medical fluid injection apparatus includes an ‘

end case’

feature whereby after an injection procedure, said operator terminates the procedure by pressing a key which will cause the medical fluid injection apparatus to count the procedure as one use of the first disposable subassembly.

29. The medical fluid injection apparatus of claim 28, further including a ‘

restart’

feature whereby when said injection apparatus is stopped prior to completion of a said injection procedure, the operator is allowed to replace said disposable subassembly with a second disposable subassembly.

30. A medical fluid injection apparatus, comprising:

a. an injector assembly with a fluid delivery mechanism to inject medical fluid;

b. a multiple-use first disposable subassembly to be used with the fluid delivery mechanism;

c. a counter to count a number of times the first disposable subassembly is used to deliver medical fluid to different patients; and

d. a user interface configured to notify an operator of the fluid injection apparatus of the number of times the first disposable subassembly has been used to deliver medical fluid and to allow the operator to either replace the first disposable subassembly with a second disposable subassembly or to continue using the first disposable subassembly.