Free flow prevention system for infusion pump.

0001The invention relates generally to infusion pumps and IV tubing sets for the controlled delivery of fluids to a patient, and more particularly to a free flow prevention system for preventing free flow of fluid through the IV tubing when the tubing is disconnected from the infusion pump.

<u style="single">Background of the Invention</u>

0002Infusion pumps are typically used to regulate the delivery of fluids, which may include potentially hazardous drugs, to a patient with a high degree of accuracy. Ordinarily, a roller clamp is moved to a closed position to stop flow through IV tubing before the tubing is removed from an infusion pump in order to prevent a situation that is sometimes referred to as "free flow" or "fluid runaway", that is, where the fluid is free to flow rapidly through the IV tubing without regulation by the infusion pump. Such roller clamps are effective in preventing free flow only when they are manually moved to their closed positions, and free flow or fluid runaway may occur if the roller clamp is left in its open position. As a result, an automatic free flow prevention system is now desired wherein fluid runaway is prevented regardless of whether the pump operator remembers to close a roller or slide clamp.

0003One approach is described in co-assigned U.S. Patent No. 4,585,441 wherein an interlock is provided to prevent removal of the IV set unless fluid flow through the tubing is stopped. The pump operator must manually close a clamp to stop fluid flow through the tubing before the infusion pump will permit removal of the IV set.

0004Another approach is to provide a permanent clamp on the infusion pump itself from which the IV set must be manually disconnected during removal of the IV set from the infusion pump. That approach reduces the risk of fluid runaway because the permanent clamp reduces the possibility of thoughtless removal of the IV set from the infusion pump. The act of disconnecting the IV set from the permanent clamp tends to remind the operator of the need to close the roller or slide clamp on the IV set; however, it does not eliminate the risk that the operator will remove the IV set without closing a clamp.

0005Other approaches include employing slide clamps to prevent or reduce the risk of removing the IV set without closing a clamp. U.S. Patent Nos. 4,586,691; 4,689,043 and 4,818,190 describe employing slide clamps to prevent fluid runaway during removal of IV sets from infusion pumps.

<u style="single">Summary of the Invention</u>

0006The invention provides a free flow prevention system adapted for preventing free flow of fluid through IV tubing when the tubing is disconnected from an infusion pump. The system is designed to be easy to use, and to automatically close the IV tubing to fluid flow when the tubing is disconnected from the infusion pump.

0007Generally, the free flow prevention system comprises IV tubing having a lumen through which fluid may be pumped for administration to a patient, and a flexible clamp associated with the IV tubing. A pumping assembly is provided that includes pumping means for pumping fluid through the IV tubing, and releasable holding means for holding the IV tubing during operation of the pumping assembly.

0008The flexible clamp has a pair of clamping arms defining a variable width slot along which the IV tubing may be moved between a first position wherein the width of the slot is sufficient to permit the clamp to be positioned longitudinally along the IV tubing, and a second position wherein the width of the slot is normally less than the width of the slot at the first position. The clamping arms are resiliently biased to a closed position wherein the IV tubing is squeezed when in its second position to close the lumen to prevent fluid flow, and are movable against the bias to an open position wherein the lumen of the IV tubing is allowed to open so that flow through the lumen is permitted.

0009Clamp-receiving means are provided on the pumping assembly for releasably receiving the flexible clamp, and releasable clamp-opening means are provided for separating the clamping arms of the flexible clamp and moving the arms from their closed position to the open position before operation of the pumping assembly. The clamp-receiving means and clamp-opening means are mounted on the pumping assembly for movement of the clamp-opening means relative to the flexible clamp received in the clamp-receiving means between an unloading position and an operating position. In the unloading position, the clamp-opening means does not hold the arms of the flexible clamp in their open position. In the operating position, the clamp-opening means moves the arms of the flexible clamp to their open position and holds the arms in the open position.

0010Other features will be in part apparent and in part pointed out hereinafter.

<u style="single">Brief Description of the Drawing</u>

0011The invention will be further described with reference to the drawing wherein corresponding reference characters indicate corresponding parts throughout the several views of the drawing, and wherein: <ul id="ul0001" list-style="none"><li>Fig. 1 is a perspective view of an infusion pump incorporating the free flow prevention system of the invention;</li><li>Fig. 2 is a cross-sectional view substantially along line 2-2 of Fig. 1, showing a flexible clamp of the free flow prevention system in its closed position;</li><li>Fig. 3 is a cross-sectional view similar to Fig. 2, showing the flexible clamp in its open position;</li><li>Fig. 4 is an enlarged bottom plan view of the flexible clamp of Figs. 2 and 3;</li><li>Fig. 5 is a bottom plan view similar to Fig. 4, illustrating another embodiment of the flexible clamp; and</li><li>Fig. 6 is a cross-sectional view similar to Figs. 2 and 3 showing a second embodiment of a clamp-receiving mechanism of the invention.</li></ul>

<u style="single">Presently Preferred Embodiments</u>

0012The infusion pump designated in its entirety by the reference numeral 10 in Fig. 1 may be of the general type described in U.S. Patent Nos. 4,236,880; 4,277,226 and 4,322,201. Such infusion pumps are designed for use with IV tubing 12 that includes a pumping cassette having flexible walls defining fluid pumping chambers which may be compressed to regulate fluid flow through the IV tubing 12. Infusion pumps of this type are being sold by AVI, Inc., a subsidiary of Minnesota Mining and Manufacturing Company of St. Paul, Minnesota. The infusion pump 10 may alternatively be of the type commonly referred to as a "linear peristaltic pump", that is, pumps that selectively squeeze straight portions of the IV tubing to regulate or pump fluid through the IV tubing. In any event, the infusion pump 10 regulates fluid flow through the lumen of IV tubing 12 for administration to a patient.

0013The infusion pump 10 includes a pumping assembly shown generally at 14 employing conventional pumping means for pumping fluid through the IV tubing 12, and a releasable holding means or assembly 16 for holding the IV tubing 12 during operation of the pumping assembly 14. Clamp-receiving means, such as the walls forming an elongate passageway 18 having an open end 19, are provided on the releasable holding means 16 of the pumping assembly 14 for releasably receiving a flexible clamp 20 associated with the IV tubing 12. And releasable clamp-opening means 22 are provided for separating the clamping arms 24 of the flexible clamp 20 and moving the arms 24 from their closed position (Fig. 2) to the open position (Fig. 3) before operation of the pumping assembly 14 so that fluid can flow through the IV tubing 12.

0014The clamp-receiving means 18 and clamp-opening means 22 are mounted on the infusion pump 10 for movement of the clamp-opening means 22 relative to a flexible clamp 20 received in the clamp-receiving means 18 between an unloading position (Fig. 2) and an operating position (Fig. 3). In the unloading position (Fig. 2), the clamp-opening means 22 does not hold the arms 24 of the flexible clamp 20 in their open position so that flow through the lumen of the IV tubing 12 is prevented before unloading the IV tubing set from the infusion pump 10. When the clamp-receiving means 18 and clamp-opening means 22 are moved from the unloading position to the operating position (Fig. 3), the clamp-opening means 22 moves the arms 24 of the flexible clamp 20 to their open position and holds the arms 24 in the open position.

0015The flexible clamp 20 (Fig. 4) includes at least a pair of the clamping arms 24, which define a variable width slot 26. The IV tubing 12 may be moved along the slot 26 between a first position 28 (Fig. 4) wherein the width of the slot 26 is sufficient to permit the clamp 20 to be positioned longitudinally along the IV tubing 12, and a second position 30 wherein the width of the slot 26 is normally less than the width of the slot 26 at the first position. The clamping arms 24 are resiliently biased to a closed position (Figs. 2 and 4) wherein the IV tubing 12 is squeezed when in its second position 30 (Fig. 2) to close the lumen to prevent fluid flow. The clamping arms 24 are movable against the bias to an open position (Fig. 3) wherein the lumen of the IV tubing 12 is allowed to open so that flow through the lumen is permitted.

0016As shown in Figs. 2 and 3, the releasable holding means 16 is preferably in the form of a door assembly 16 including an IV pumping cassette-receiving block 32 of the type described in U.S. Patent No. 4,236,880, and a door 34 pivotably mounted on the cassette-receiving block 32 by a hinge. As described in U.S. Patent No. 4,236,880, the door assembly 16 may be manually moved between a loading and unloading position (Fig. 2) and an operating position (Fig. 3) by turning a knob 36 extending laterally outwardly from a side of the infusion pump 10. In the loading and unloading position (Fig. 2), the door assembly 16 is spaced from the main body 38 of the infusion pump 10 a distance D-1 sufficient to permit the door 34 to be pivoted outwardly for loading and unloading the pumping cassette of the IV tubing 12. When the door assembly 16 is moved to the operating position (Fig. 3), the door assembly 16 is moved toward the main body 38 of the infusion pump 10 to bring the pumping cassette into position for proper operation of the pistons of the pumping means.

0017The clamp-opening means 22 preferably includes a wedge 22 mounted on the main body 38 of the pumping assembly 14, and the clamp-receiving passageway 18 is preferably formed in the cassette-receiving block 32 of the door assembly 16. For example, a guide block 37 may be provided on the cassette-receiving block 32 to form the passageway 18. When the door assembly 16 is in its loading and unloading position (Fig. 2), the IV tubing 12 may be loaded into or unloaded from the pumping assembly 14, and the wedge 22 and flexible clamp 20 are in their unloading position after the clamp 20 is fully inserted in the clamp-receiving passageway 18. And when the door assembly 16 is moved to the operating position (Fig. 3), the flexible clamp 20 is carried along in the clamp-receiving passageway 18 toward the wedge 22 to the operating position, with at least a portion the wedge 22 positioned between the clamping arms of the flexible clamp to move the clamping arms 24 to their open position.

0018A projecting portion or pin 38 preferably extends downwardly from the bottom edge 39 of the door 34. The pin 38 is adapted for releasably retaining the flexible clamp 20 in the elongate passageway 18 after the clamp 20 is manually inserted in the passageway 18 and the door 34 is closed against the cassette-receiving block 32. It will be observed that the pin 38 does not prevent removal of the clamp 20 when the door 34 is open. The pin 38 engages a ledge 40 extending laterally outwardly from the inner end of one of the clamping arms 24 to hold the clamp 20 against longitudinal movement (downwardly in Figs. 2 and 3) when the wedge 22 separates the clamping arms 24 of the clamp 20.

0019The flexible clamp 20 preferably comprises a body formed of thermoplastic or synthetic resin material, and a resilient spring member 42 biasing the clamping arms 24 to their closed position (Fig. 2). The body of the flexible clamp 20 includes a hinged bridging portion 44 defining an inner end of the slot 26, and the clamping arms 24. The clamping arms 24 of the clamp 20 extend outwardly (upwardly in Fig. 4) from the bridging portion 44, and terminate in free ends 46 that define the outer end of the slot 26. The free ends 46 of the clamping arms 24 are tapered inwardly toward the slot 26 and bridging portion 42 to guide the wedge 22 into the outer end of the slot 26 between the clamping arms 24.

0020The clamping arms 24 have inner surface portions between the inner end of the slot 26 and their free ends 46, preferably generally adjacent their free ends, that define the first (wide) position 28. And the inner end of the slot 26 may be, for example, generally adjacent the second position 30 as shown in Figs. 2-4, with a portion of the clamping arms 24 generally adjacent the bridging portion 44 defining an open area as the second (narrow) position. The slot 26 defines the longitudinal direction or axis of the clamp 20.

0021Abutment means, such as ledges 40 and 41 extending laterally outwardly from opposite sides of the clamp 20, may be provided on the clamp 20. The ledges 40 and 41 limit insertion of the clamp 20 into the elongate passageway 18 to a first predetermined distance, with the first and second positions 28 and 30 of the IV tubing 12 being spaced apart along the longitudinal axis of the clamp 12 a second predetermined distance substantially equal to the first predetermined distance. In other words, the ledges 40 and 41 are preferably spaced from the free ends 46 of the clamping legs 24 a distance substantially equal to the distance separating the first and second positions 28 and 30. And the cassette-receiving block 32 of the pumping assembly 14 includes a wall 48 substantially preventing movement of the IV tubing 20 into the passageway 18 as the clamp 20 is inserted into the passageway 18 so that the IV tubing 18 is moved from the first position 28 to the second position 30 when the clamp 20 is manually inserted in the passageway 18 the first predetermined distance.

0022A sensor 50 (Figs. 2 and 3) may be provided to determine when the clamp 20 is fully inserted in passageway 18, and the infusion pump 10 may include alarm circuitry responsive to the sensor 50, and may even be electrically disabled when the sensor 50 fails to indicate a fully inserted clamp 20. The sensor 50 includes a proximity switch 52 and a suitable linkage 54 for tripping the proximity switch 52 when the clamp 20 is fully inserted.

0023Fig. 5 illustrates a second embodiment of a flexible clamp 20A, which includes two bridging portions 56 joining the clamping arms 24A and defining opposite ends of the variable width slot 26A. The bridging portions 56 and/or clamping arms 24A are sufficiently flexible to permit the clamping arms 24A to be moved against the bias to their open position (Fig. 5) despite the addition of a second bridging portion 56. Fig. 5 also illustrates how a clamp-opening wedge 22A may be used with this alternative design. The wedge 22A would be driven into the slot 26A in the transverse direction (i.e., perpendicular to the sheet of the drawing in Fig. 5) to separate the clamping arms 24A.

0024Fig. 6 illustrates another embodiment of the free flow prevention system wherein a pivotable arm 58 is provided for releasably retaining the flexible clamp 20B in the passageway 18B when the clamp 20B is inserted the first predetermined distance. The pivotable arm 58 is preferably pivotably mounted on the cassette-receiving block 32B so that the arm 58 moves with the door assembly 16B. The door 34B has a pivotable projecting portion 60 spring biased to a holding position (Fig. 6) for pressing or holding the pivotable arm 58 against the clamp 20B when the door 34B is moved to a closed position. And the projecting portion 60 is movable against the spring bias by the pivotable arm 58 when the clamp 20B is partially inserted in the passageway 18B and the door 34B is closed. This ability to move against the spring bias is believed to prevent jamming of the door 34B when the clamp 20B is only partially inserted in the passageway 18B.

0025The operation of the free flow prevention system will be described with respect to the embodiment shown in Figs. 2-4. With the IV tubing 12 at the first (wide) position 28 in the slot 26, the clamp 20 is moved longitudinally along the tubing 12 to a position appropriate for insertion of both the tubing 12 and clamp 20 into the infusion pump 10. The IV tubing 12, including the pumping cassette, if any, and the clamp 20 are then manually placed or inserted into the cassette-receiving block 32 and the clamp-receiving passageway 18, with the IV tubing 12 moving to the second position 30 in the clamp's slot 26 as the clamp 20 is inserted. The door 34 of the door assembly 16 is then closed to hold the clamp 20, cassette and IV tubing 12 in the door assembly 16, and the knob 36 is turned to pull the door assembly 16 toward the main body 38 of the pumping assembly 14. As the door assembly 16 moves toward the main body 38 of the pumping assembly 14, the wedge 22 is forced between the clamping arms 24 of the clamp 20 to move them to the open position (Fig. 3) to permit fluid flow through the IV tubing 12 during operation of the pump 10.

0026In order to remove the IV tubing set from the pump 10, the knob 36 is turned in the opposite direction to return the door assembly 16 to its loading and unloading position (Fig. 2), where it is spaced from the main body 38 of the pumping assembly 14. The door 34 is then opened, and the IV tubing set, including the IV tubing 12 and clamp 20, are removed from the infusion pump 20, with the the lumen of the IV tubing 12 being closed due to the clamping action of the clamping arms 24 against the tubing 12 at the second position 28. As a result, free flow through the tubing 12 is prevented during and after disconnection of the IV tubing set regardless of whether a standard roller clamp (not shown) is closed.

0027As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawing be interpreted as illustrative and not in a limiting sense.