Physiological fluid warming process and apparatus

• US 6,229,957 B1
• Filed: 05/14/1999
• Issued: 05/08/2001
• Est. Priority Date: 05/14/1999
• Status: Expired due to Fees

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Inventors: Baker, Joseph
• Primary Examiner(s): Jeffery, John A.
• Application Number:
  US09/312,459
• Time in Patent Office: 725 Days
• Field of Search: 392/470, 392/480-481, 392/488, 604/113-114, 219/501, 219/497, 219/485, 219/482
• US Class Current: 392/470
• CPC Class Codes: A61M 2205/3633 thermally insulated
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

The present invention provides both a process and apparatus for rapidly warming and delivering relatively high volumes of a physiological fluid. Unique to this invention is the ability to warm and infuse physiological fluids at a rate of up to about 1000 ml/min without causing damage to the fluid components, e.g. lysing or rupture of cells, or upsetting the normothermic equilibrium of the patient. Further unique to this invention is the utilization of a 12 VDC source, e.g. a battery source, as an amperage supplement to be used simultaneously with an AC power source, thereby enabling the heating of physiological fluids at a rate which surpasses that normally attainable through the sole use of facility provided AC power.

Claims

1. A warming device for a physiological fluid selected from the group consisting of crystalloids, synthetic colloids, blood products, whole blood, packed cells, plasma and mixtures thereof comprising:

1) a warm water bath assembly including air detecting means and line clamping means;

2) a disposable heat exchanger assembly and Y-set adapted for removable engagement and fluid coupling within said warm water bath assembly;

3) a warm water bath assembly power management and temperature control device, characterized by a self-contained 12 volt DC power supply and a concurrent 112 volt AC power supply, constructed and arranged to provide power concurrently and in an amount effective to maintain physiological fluid temperature within nominal design parameters; and

4) a warm water bath cover assembly containing an operator panel constructed and arranged to contain an integral line pump;

wherein physiological fluids are delivered to a patient at a flow rate and temperature characterized as being within nominal design parameters effective to correct hypovolemic conditions while maintaining patient temperature within normothermic limits.

2. The warming device of claim 1 wherein the fluid is supplied to the patient at flow rates of up to about 1000 cc/min and at temperatures within normothermic limits, said temperatures varying about 0.5°

C. between said warming device and the patient.

3. The warming device of claim 1, wherein said Y-set requires from 50-100 ml priming volume.

4. The warming device of claim 1 wherein said Y-set is characterized as containing insulated plastic tubing effective to maintain the physiological fluid at normothermic limits with a tolerance of at least about +/−

0.5°

C. at a flow rate of up to about 1000 cc/min.

5. The warming device of claim 1 wherein said DC power source is effective to provide up to about 500 cc/min of warmed physiological fluid in a temperature range of about 33°

C. to 40.5°

C. with a tolerance of at least about +/−

0.5°

C.

8. The fluid warming device of claim 1, wherein said heat exchanger is spirally configured and contained within a housing constructed and arranged for plug-in interfacing with a centrally disposed mounting surface within a warm water reservoir;

and wherein said heat exchanger is configured such that the water connections are axially aligned and are self-sealing upon assembly;

said heat exchanger assembly being further characterized by integral means for physiological fluid filtration and air venting, said physiological fluid filtration and air venting means being located within the warm water reservoir whereby heat loss to the surroundings are minimized.

9. The fluid warming device in accordance with claim 1 wherein said air detection means includes an ultrasonic air detector for sensing air bubbles within the physiological fluid within a time window, which means is electronically coupled to shutoff means characterized as an electronic solenoid controlled line clamp, and wherein, upon the concentration of air bubbles exceeding a particular value, said air detection means provides a signal to the solenoid controlled clamp to prevent fluid flow to the patient.

10. The fluid warming device of claim 9 wherein the particular value of air bubble concentration should not exceed about 50-100 microliters air bubble volume.

6. In combination with a warming device for physiological fluids, a power management system for integration of a 12 VDC power source and a 112 VAC power source, in combination and in response to power requirements as commanded by a temperature control assembly;

said power management system including, in electrical communication, an isolation transformer, a full wave rectifier and a battery charging device, constructed and arranged to simultaneously provide DC power to the device in an amount effective to maintain physiological fluid temperature within nominal design parameters and providing automatic charge maintenance of the 12 VDC system.

7. In combination with a physiological fluid warming device for delivering said fluid to a patient, said warming device utilizing both AC and DC sources of electric power, a temperature control system characterized by a combination of analog and digital controllers utilizing proportional and integral control algorithms, system models and dynamic compensation to calculate AC and DC power requirements whereby said physiological fluid is infused to a patient at a temperature which is maintained within nominal design temperature parameters effective to prevent hypothermia induced shock.

11. A disposable Y-set and heat exchanger assembly for use in a physiological fluid warming system comprising:

tapping means for attachment to one or more vessels containing a physiological fluid to be heated, said fluid selected from the group consisting of whole blood, packed cells, plasma or mixtures thereof, said tapping means constructed and arranged to provide for a flow of liquid from said vessels and being in fluid connection with flow control means to prevent flow reversal;

an adjustable flow control valve in series connection therewith for providing volumetric flow control within the physiological fluid warming system;

a heat exchanger assembly constructed and arranged for plug-in fluid coupling with a source of warming fluid, said assembly including a reservoir for maintaining a desired volume of warming fluid and a means for providing traversal of said fluid to be heated within said reservoir, in heat exchange relationship with said warming fluid, thereby creating a warmed fluid, said assembly further including integral means for venting air and providing filtration of said warmed fluid, and insulated outlet means for directing said warmed fluid to a Y-coupling;

said Y-coupling, which is in fluid communication with said heat exchanger assembly, being fluidly connected to one or more insulated fluid conduits each of which is in fluid communication with flow control valves.

12. The disposable Y-set and heat exchanger assembly of claim 11, further including:

one or more locking connector means;

wherein each of said one or more locking connector means are removably attached to a fluid conduit which is fluidly coupled to the bloodstream of a patient.