Apparatus and method for limiting free-flow in an infusion system

• US 5,788,674 A
• Filed: 03/05/1996
• Issued: 08/04/1998
• Est. Priority Date: 03/05/1996
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc., The Dow Chemical Company (Dow, Inc.)
• Original Assignee: Medication Delivery Devices, Inc. (Baxter International Inc.)
• Inventors: McWilliams, Mark D.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/611,274
• Time in Patent Office: 882 Days
• Field of Search: 604/131, 604/118, 604/246, 604/403, 604/905, 604/280, 604/283, 604/151, 604/141, 604/65, 604/67
• US Class Current: 604/141
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow

Abstract

A detachable apparatus for limiting the rate at which a fluid is supplied to a patient by a positive pressure infusion device. The infusion device has an operating device pressure of at least approximately 2 psi. The apparatus includes a constrained flow segment (or CFS), coupleable to and detachable from the infusion device, for delivering fluid to the patient from the infusion device. The CFS has a length, an inside diameter, and a hydraulic resistance. The hydraulic resistance is a function of the length and inside diameter. When the apparatus is not in a free-flow condition, the CFS delivers fluid to the patient at a controlled flow rate determined by the operating device pressure and the hydraulic resistance of the CFS. When the apparatus is in a free-flow condition, the hydraulic resistance of the CFS limits a maximum flow rate of the apparatus to less than about 50% of the controlled flow rate. An adaptor is also provided for enabling a non-activating intravascular set ("IV set") to be used with an infusion device designed to be used only with an activating IV set. The infusion device has a detector element for detecting whether an IV set being used with the infusion device is an activating IV set. The infusion device is activated in response to detection of an activating IV set and is disabled if no such IV set is detected. The adaptor comprises an active element, independent of an IV set, for interacting with the detector element. The active element causes the detector element to detect the presence of an activating IV set when, in reality, a non-activating IV set is being used.

Claims

1. A detachable apparatus for limiting the rate at which a fluid is supplied to a patient by a positive pressure infusion device, the infusion device having an operating device pressure of at least approximately 2 psi, the detachable apparatus comprising:

a constrained flow segment ("CFS"), coupleable to and detachable from the infusion device for delivering fluid to the patient from the infusion device, the CFS having a length in a range of about 28 to 38 inches, an inside diameter in a range of about 0.0025 to 0.05 of an inch, and a hydraulic resistance which is a function of the length and inside diameter;

the CFS for (1) delivering fluid to the patient from the infusion device at a controlled flow rate determined by the operating device pressure and the hydraulic resistance of the CFS when the detachable apparatus is not in a free-flow condition, and (2) limiting a maximum flow rate of the detachable apparatus by the hydraulic resistance of the CFS to a range of approximately 7% to 16% of the controlled flow rate when the detachable apparatus is in a free-flow condition.

2. The apparatus of claim 1 wherein the CFS has a tubing segment having a length in a range of about 28 to 40 inches.

3. The apparatus of claim 2 wherein the inside diameter of the tubing segment is in a range of about 0.003 to 0.025 of an inch.

4. A detachable apparatus for limiting the rate at which a fluid is supplied to a patient by a positive pressure infusion device, the infusion device having an operating device pressure of at least approximately 2 psi, the detachable apparatus comprising:

a constrained flow segment ("CFS"), coupleable to and detachable from the infusion device, for delivering fluid to the patient from the infusion device, the CFS having a length in a range of about 28 to 38 inches, an inside diameter in a range of about 0.0025 to 0.05 of an inch, and a hydraulic resistance which is a function of the length and inside diameter;

the CFS for (1) delivering fluid to the patient from the infusion device at a controlled flow rate determined by the operating device pressure and the hydraulic resistance of the CFS when the detachable apparatus is not in a free-flow condition, and (2) limiting a maximum flow rate of the detachable apparatus by the hydraulic resistance of the CFS to a range of approximately 30% to 60% of the controlled flow rate when the detachable apparatus is in a free-flow condition.

5. The apparatus of claim 4 wherein the CFS has a tubing segment having a length in a range of about 60 to 76 inches.

6. The apparatus of claim 5 wherein the inside diameter of the tubing segment is in a range of about 0.004 to 0.035 of an inch.

7. A detachable apparatus for limiting the rate at which a fluid is supplied to a patient by a positive pressure infusion device. the infusion device having an operating device pressure of at least approximately 2 psi, the detachable apparatus comprising:

a constrained flow segment ("CFS"), coupleable to and detachable from the infusion device, for delivering fluid to the patient from the infusion device, the CFS having a length in a range of about 28 to 38 inches, an inside diameter in a range of about 0.0025 to 0.05 of an inch, and a hydraulic resistance which is a function of the length and inside diameter;

the CFS for (1) delivering fluid to the patient from the infusion device at a controlled flow rate determined by the operating device pressure and the hydraulic resistance of the CFS when the detachable apparatus is not in a free-flow condition, and (2) limiting a maximum flow rate of the detachable apparatus by the hydraulic resistance of the CFS to a range of approximately 16% to 30% of the controlled flow rate when the detachable apparatus is in a free-flow condition.

8. The apparatus of claim 7 wherein the CFS has a tubing segment having a length in a range of about 60 to 76 inches.

9. The apparatus of claim 8 wherein the inside diameter of the tubing segment is in a range of about 0.003 to 0.03 of an inch.

10. A method for limiting the rate at which fluid is supplied to a patient by a positive pressure infusion device, the method comprising the steps of:

(a) coupling a detachable constrained flow segment ("CFS") to a positive pressure infusion device having an operating device pressure of at least approximately 2 psi the CFS having a length, an inside diameter, and a hydraulic resistance which is a function of the length and the inside diameter;

(b) delivering fluid to the patient at a controlled rate determined by the operating device pressure and the hydraulic resistance of the CFS when the infusion device is in a non-free-flow condition; and

(C) limiting a maximum flow rate of the CFS to less than about 50% of the controlled flow rate when the CFS is in a free-flow condition.

11. The method of claim 10, wherein the CFS has a tubing segment, the method further comprising the steps of:

(a) selecting the length of the tubing segment to be in a range of about 28 to 80 inches;

(b) selecting the inside diameter of the tubing segment to be in a range of about 0.0025 to 0.05 of an inch; and

(c) selecting the operating device pressure to be in a range of approximately 4.5 to 13 psi.

12. The method of claim 11, further comprising selecting the operating device pressure to be in a range of about 5 to 8 psi and the maximum flow rate of the CFS in a free-flow condition to be in a range of approximately 13% to 30% of the controlled flow rate.

13. The method of claim 11, further comprising selecting the operating device pressure to be in a range of about 9 to 12 psi and the maximum flow rate of the CFS in a free-flow condition to be in a range of approximately 7% to 16% of the controlled flow rate.

14. The method of claim 11, further comprising selecting the operating device pressure to be in a range of about 5 to 8 psi and the maximum flow rate of the CFS in a free-flow condition to be in a range of approximately 30% to 50% of the controlled flow rate.

15. The method of claim 11, further comprising selecting the operating device pressure to be in a range of about 9 to 12 psi and the maximum flow rate of the CFS in a free-flow condition to be in a range of approximately 16% to 30% of the controlled flow rate.

16. An adaptor for enabling a non-activating intravascular set ("IV set") to be used with an infusion device, where the infusion device is configured for use with an activating IV set, the infusion device having a detector element for detecting whether an activating IV set is being used with the infusion device, the infusion device being activated in response to detection of an activating IV set such that the infusion device is disabled if the detector element fails to detect an activating IV set, the adaptor comprising:

an active element, independent of the non-activating IV set, for interacting with the detector element and causing the detector element to detect the presence of an activating IV set when the non-activating IV set is being used with the infusion device.

17. The adaptor of claim 16, further comprising:

(a) holder means for holding the active element and for facilitating interaction between the active element and the detector element.

18. The adaptor of claim 17 wherein the holder means has an extension end and a detector end, the extension end being coupled to a constrained flow segment of the non-activating IV set and the detector end being for engaging the detector element.

19. The adaptor of claim 18 wherein the detector end of the holder means has a first portion and a second portion, the first portion having a recess for accepting the active element and the second portion covering the recess.

20. The adaptor of claim 19, further comprising an adhesive for bonding the first portion to the second portion.

21. The adaptor of claim 16 wherein the active element comprises means for magnetically activating the infusion device.

22. The adaptor of claim 21 wherein the active element comprises a metallic object for activating a magnetic switch of the infusion device.

23. The adaptor of claim 16, further comprising a reflective surface for reflecting a wave radiated by the detector back to the detector.

24. The adaptor of claim 16 wherein the active element comprises means for completing an electric circuit of the detector.

25. A system for enabling an infusion device to be used with a non-activating intravascular set ("IV set"), where the infusion device is configured for use with an activating IV set, the system comprising:

(a) a detector, coupled to the infusion device, for detecting whether an activating IV set is being used with the infusion device, whereby the infusion device is disabled if the detector fails to detect the presence of an activating IV set; and

(b) an adaptor for enabling the infusion detector to be used with the non-activating IV set, the adaptor including an active element, independent of the non-activating IV set, for indicating to the detector the presence of an activating IV set when the non-activating IV set is actually being used with the infusion pump.

26. The system of claim 25 wherein the adaptor further includes holder means having a first portion with a recess for holding the active element and a second portion for covering the recess and active element.

27. The system of claim 25 wherein the adaptor further includes holder means for holding the active element and engaging the detector, the holder means having at least one tab for securing the holder means to the detector.

28. The system of claim 25, the system further comprising a coupler for coupling the active element to the non-activating IV set.

29. An adaptor for enabling a non-activating intravenous set ("IV set") to be used with an infusion device, where the infusion device is configured for use with an activating IV set, the activating IV set having a constrained flow segment ("CFS") and the infusion device having a detector for detecting whether an activating IV set is being used with the infusion device, such that the infusion device is disabled if the detector fails to detect the presence of an activating IV set, the adaptor comprising:

(a) a holder; and

(b) an active element, held by the holder, for indicating to the detector that an activating IV set is present and thereby activating the infusion device when the non-activating IV set is being used with the infusion device and when the holder is placed relative to the infusion device in a manner that allows interaction between the active element and the detector.

30. The adaptor of claim 29 wherein the active element comprises an electronic element.

31. The adaptor of claim 29 wherein the active element comprises a magnetic element.

32. A method for enabling a non-activating intravascular set ("IV set") to be used with an infusion device, where the infusion device is configured for use with an activating IV set, the infusion device having a detector for detecting whether an activating IV set is being used with the infusion device, such that the infusion device is disabled if the detector fails to detect the presence of an activating IV set, the method comprising the steps of:

(a) placing a non-activating IV set in the infusion device;

(b) positioning an active element relative to the detector;

(c) detecting the presence of the activating IV set by the detector in response to step (b); and

(d) enabling the infusion device in response to step (c).