Blood warming apparatus

• US 6,047,108 A
• Filed: 10/01/1996
• Issued: 04/04/2000
• Est. Priority Date: 10/01/1996
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Reed, Michael A., Collins, John M., de Castro, Jose Tadeo, Forni, Ronald J., Sword, Randall Jay
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): CAMPBELL, THOR S
• Application Number:
  US08/724,687
• Time in Patent Office: 1,281 Days
• Field of Search: 392/470, 392/466, 392/480, 392/479, 392/465, 219/432, 219/433, 219/435, 219/535, 219/534, 219/497, 604/113-114
• US Class Current: 392/470
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

An apparatus (10) for the controlled heating of fluid comprises a general elongated electrically heating core (16) with an exterior surface (36) formed of a material having a high thermal conductivity and frustoconically shaped to slidingly receive an assembly (14) so that the assembly envelops the surface along at least a portion of the length of the core. The assembly (14) forms a sealed passageway (46) for generally unidirectional sheet-like flow upward along the core (16). A control system (20) selectively operates the heating core (16) so that the fluid, under varying flow rates, is warmed to a desired temperature without overheating, before the fluid flows from the passageway (46).

Claims

1. An apparatus for warming a flow of parenteral fluid through an assembly, the assembly having an inlet and an outlet and forming a passageway for the flow of parenteral fluid through the assembly, the apparatus comprising:

a general elongated mandrel having an exterior surface formed of a material having a high thermal conductivity and shaped to slidingly receive the assembly so that the assembly envelops the surface along at least a portion of the length of the mandrel;

a selectively controlled heater in conductive contact with the surface, a control circuit operably connected to the heater and including at least one first temperature sensor to sense a temperature of the mandrel at a location on the surface in close proximity to the inlet of the assembly when the assembly is placed about the mandrel and means for adjusting heat output of the heater in dependence at least in part on a rate of change of temperature sensed by the first temperature sensor.

2. The apparatus of claim 1 wherein the control system further includes at least one second sensor to sense a temperature of the mandrel at a location in close proximity to an outlet of the assembly and means for adjusting the heat output based at least in part on the temperature sensed by the second sensor.

3. The apparatus of claim 2 wherein the control systems includes a plurality of second sensors and means to compare the difference in temperatures being sensed by the second temperature sensors with a predetermined value.

4. The apparatus of claim 1 wherein the control system includes a plurality of first temperature sensors, and means to compare the difference in temperatures being sensed by the first temperature sensors with a predetermined value.

5. An apparatus for warming a flow of parenteral fluid through an assembly, the assembly having an inlet and an outlet and forming a passageway for the flow of patenteral fluid through the assembly, the apparatus comprising:

a general elongated mandrel having an exterior surface formed of a material having a high thermal conductivity and shaped to slidingly receive the assembly so that the assembly envelops the surface along at least a portion of the length of the mandrel;

a selectively controlled heater in conductive contact with the surface; and

a control circuit operably connected the heater and including at least one first temperature sensor to sense the temperature at a location on the surface and a means for varying the heater output based at least in part on the temperature sensed by the first temperature sensor, said varying means including first means for varying the heat output to obtain a desired temperature in at least partial dependence on the sensed temperature, and second means for shutting off power to the heater when the sensed temperature is at least one of equal to or greater than an upper limit temperature.

6. An apparatus for warming a flow of fluid comprising:

an assembly shaped generally frusto-conical and defining a longitudinal axis, the assembly forming an inlet and outlet and a sealed passageway for the fluid from the inlet to the outlet, the inlet being proximate one end of the assembly and the outlet being proximate the other end of the assembly, the assembly including an exterior restraint defining an outer boundary of the passageway;

a general elongated heated mandrel defining a longitudinal axis, the mandrel having an exterior surface with at least a portion formed of a material having a high thermal conductivity and shaped to slidingly receive the assembly so that the assembly envelops the exterior surface along at least a portion of the length of the mandrel, the exterior surface defining an inner boundary of the passageway, the assembly and the exterior surface of the mandrel being configured to form the passageway with a generally constant thickness over at least a portion of the length of the passageway when the assembly is disposed in a desired position relative to the mandrel.

7. The apparatus of claim 6 wherein the assembly includes a flexible sidewall forming an interior wall for the passageway.

8. The apparatus of claim 7 wherein the assembly includes a bag sealingly forming the passageway.

9. The apparatus of claim 6 wherein the assembly is configured to engage the mandrel and dispose the assembly in the desired relative position.

10. The apparatus of claim 9 where in the assembly includes means attached to the restraint for engaging the mandrel and establishing the desired relative position.

11. The apparatus of claim 6 wherein at least one of the restraint and the mandrel are configured to form an inlet manifold portion and a second portion of the passageway, the inlet manifold having a thickness greater than the thickness of the second portion, the second portion extending a majority of the length of the passageway along the mandrel.

12. The apparatus of claim 11 wherein the inlet manifold is configured to extend circumferentially about the mandrel.

13. The apparatus of claim 11 wherein the mandrel includes a radial groove defining the inlet manifold.

14. The apparatus of claim 11 wherein the assembly is configured to direct an inlet flow of fluid along the inlet manifold.

15. The apparatus of claim 11 wherein the assembly includes means for directing an inlet flow of blood along the inlet manifold.

16. The apparatus of claim 6 wherein the restraint and mandrel are configured to form the passageway with a generally uniform thickness over the majority of the length of the passageway.

17. The apparatus of claim 6 wherein the internal surface of the restraint is frustro/conically shaped and free of shapes which may pinch the passageway over a majority of the length of the passageway.

18. The apparatus of claim 11 wherein the assembly is configured to direct an inflow of blood out into the inlet manifold in a direction tangential to the exterior surface of the mandrel and generally normal relative to a longitudinal axis defined by the mandrel.

19. The apparatus of claim 6 wherein at least one of the restraint and the mandrel are configured to form an outlet manifold portion of the passageway, the outlet manifold having a thickness greater than the thickness of a portion of the passageway extending over a majority of the length of the passageway along the mandrel.

20. The apparatus of claim 19 wherein the outlet manifold is configured to extend circumferentially about the mandrel in close proximity to an end of the mandrel.

21. The apparatus of claim 19 wherein the mandrel includes a radial groove defining a portion of the outlet manifold.

22. The apparatus of claim 19 wherein the assembly is configured to direct an outlet flow of fluid from the passageway in a direction generally aligned with the outlet manifold.

23. The apparatus of claim 19 wherein the assembly is configured to direct an outflow of blood out of the inlet manifold in a direction tangential to the exterior of the mandrel and generally normal relative to a longitudinal axis defined by the mandrel.

24. A process for adjusting the heat output of a parenteral fluid warming heater having a heating mandrel and an assembly disposed about the mandrel, the assembly providing a sealed passageway for a flow of a parenteral fluid through the heater, the process being characterized by the fact that it comprises the steps of:

choosing a target temperature;

measuring a first temperature at a first location on the mandrel;

measuring a second temperature at a second location on the mandrel; and

adjusting a heat output of the mandrel in dependence on both a difference between the target temperature and the first temperature and a rate of change of the second temperature.

25. The process of claim 24 wherein the adjusting includes varying power supplied to a electric heating element in heat conductive contact with the mandrel and further including the steps of

choosing an upper temperature limit greater than the target temperature;

comparing at least one of the first temperature and the second temperature to the upper temperature limit; and

switching off the power to the heating element when the at least one of the first temperature and the second temperature is at least one of equal to and greater than the upper temperature limit.

26. The process of claim 25 further including the steps of choosing an alarm temperature;

comparing at least one of the first temperature and the second temperature with the alarm temperature; and

generating an alarm when the at least one of the first temperature and the second temperature is at least one of equal to and greater than the alarm temperature.

27. The process of claim 25 further including:

measuring a third temperature at a third location on the mandrel;

comparing the third temperature with at least one of the first temperature and the second temperature; and

generating an alarm signal when a difference between the third temperature and the compared temperature is at least one of equal to and greater than a predetermined temperature differential.

28. An apparatus for warming a flow of fluid comprising:

an assembly shaped generally frustum-conical and defining a longitudinal axis, the assembly forming an inlet and outlet and a sealed passageway for the fluid from the inlet to the outlet, the inlet being proximate one end of the assembly and the outlet being proximate the other end of the assembly, the assembly including an exterior restraint defining an outer boundary of the passageway;

a general elongated heated mandrel defining a longitudinal axis, the mandrel having an exterior surface with at least a portion formed of a material having a high thermal conductivity and shaped to slidingly receive the assembly so that the assembly envelops the exterior surface along at least a portion of the length of the mandrel, the assembly and the exterior surface of the mandrel being configured to form the passageway so that as fluid flows through the passageway the fluid flow forms a generally uninterrupted sheet like flow over a majority of the surface area of the mandrel when the assembly is disposed in a desired position relative to the mandrel.

29. An apparatus for warming a flow of fluid through an assembly shaped generally frustum-conical and defining a longitudinal axis, the assembly forming an inlet and outlet and a sealed passageway for the fluid from the inlet to the outlet, the inlet being proximate one end of the assembly and the outlet being proximate the other end of the assembly, the assembly including an exterior restraint defining an outer boundary of the passageway, the apparatus comprising:

a general elongated heated mandrel defining a longitudinal axis, the mandrel having an exterior surface with at least a portion formed of a material having a high thermal conductivity and shaped to slidingly receive the assembly so that the assembly envelops the exterior surface along at least a portion of the length of the mandrel, the mandrel forming a hollow interior cavity; and

a electrical sheet heater disposed within the cavity and in conductive contact with the mandrel, the heater formed with a plurality of bands of differing heat output along the length of the mandrel.

30. The apparatus of claim 29 wherein the heat output of a first band of the bands is greater than a second band of the bands, the first band being disposed in close proximity to the inlet of the assembly when the assembly is slidingly disposed about the mandrel.