Granted Patent B2

US 12,741,073 · App. 18/241,775 · Granted Sep 22, 2026

Inventors: Marc E. Voorhees (Arvada, CO); Christopher Park (Oregonia, OH); Salvatore Privitera (Mason, OH)

Assignee: Medivance Incorporated

A61M1/369A61F7/0085A61F7/12A61M5/14A61M60/113A61M60/515A61F2007/0056A61F2007/0086A61F2007/0096A61M60/268A61M60/538A61M60/857A61M2205/3355A61M2205/3368

Abstract

Claims (57)

1 . A system for extracorporeal blood temperature control, comprising:

a heat exchanger configured to cool a circulated fluid;

a thermal exchange module comprising a first volume fluidly isolated from a second volume;

a fluid pump configured to pump the circulated fluid through the heat exchanger and the first volume of the thermal exchange module, wherein operation of the fluid pump establishes a negative pressure within the first volume of the thermal exchange module;

a blood pump configured to pump blood through a first blood flow line, the second volume of the thermal exchange module, and a second blood flow line; and

a controller configured to cool the blood by controlling thermal exchange between the circulated fluid pumped through the first volume of the thermal exchange module and the blood pumped through the second volume of the thermal exchange module.

2 . The system according to claim 1 , wherein:

an inlet port of the fluid pump is fluidly interconnected to an outlet port of the first volume of the thermal exchange module,

the outlet port of the thermal exchange module is fluidly interconnected to a reservoir of the heat exchanger,

the reservoir of the heat exchanger is fluidly interconnected to an outlet port of the fluid pump, and

upon operation of the fluid pump, reservoir fluid is drawn from the reservoir of the heat exchanger through the first volume of the thermal exchange module and to the inlet port of the fluid pump.

3 . The system according to claim 1 , further comprising a fluid temperature sensor configured to sense a temperature of the circulated fluid and to provide a fluid temperature signal.

4 . The system according to claim 3 , further comprising a blood temperature sensor configured to sense a temperature of the blood pumped through the second volume of the thermal exchange module and to provide a blood temperature signal, the controller configured to utilize the blood temperature signal for use in operation of the blood pump.

5 . The system according to claim 3 , wherein the controller is configured to receive a patient temperature signal indicative of a sensed patient temperature, and to utilize the sensed patient temperature together with the fluid temperature signal to generate an output signal.

6 . The system according to claim 1 , further comprising a multi-lumen catheter configured to fluidly connect to the first blood flow line and the second blood flow line.

7 . The system according to claim 6 , wherein the multi-lumen catheter comprises:

a first port, a second port, and a third port;

a first lumen configured to fluidly interconnect to the first port and to the first blood flow line;

a second lumen configured to fluidly interconnect to the second port and to the second blood flow line; and

a third lumen configured to fluidly interconnect to the third port an optional component.

8 . The system according to claim 7 , wherein the optional component comprises a source of an optional fluid selected from the group consisting of an anticoagulant, an anti-shivering agent, a contrast media, and a cooled fluid.

9 . The system according to claim 6 , wherein the blood pump, the first blood flow line, the second blood flow line, and the multi-lumen catheter are configured to accommodate blood flow through the second volume of the thermal exchange module at a blood flow rate in a range from about 50 ml/min to about 300 ml/min.

10 . The system according to claim 9 , wherein the system is configured to accommodate fluid flow through the first volume of the thermal exchange module at a fluid flow rate about five times greater than the blood flow rate.

11 . The system according to claim 9 , wherein the thermal exchange module includes a heat exchange performance factor N>0.8 across the range of the blood flow rate, wherein:

N

=

T

b

⁢

o

-

T

bi

T

cfi

-

T

bi

;

and,

T bo =temperature of blood flowing out of thermal exchange module;

T bi =temperature of blood flowing in to thermal exchange module; and,

T cfi =temperature of circulated fluid flowing in to thermal exchange module.

12 . The system according to claim 1 , wherein the controller comprises a programmable processor control module for storing control data in relation to a plurality of different temperature control phases during which a temperature of the circulated fluid is controlled differently, wherein the programmable processor control module comprises control logic for utilizing the control data to provide output signals.

13 . The system according to claim 12 , wherein the heat exchanger is further configured to warm the circulated fluid, and wherein the control data comprises:

cooling control data for use by the control logic in providing the output signals to the heat exchanger to cool the blood in at least one of the plurality of different temperature control phases; and

warming control data for use by the control logic in providing the output signals to the heat exchanger to warm the blood in at least another of the plurality of different temperature control phases.

14 . The system according to claim 12 , further comprising a user interface for receiving user input and providing user control signals, wherein the control logic utilizes the user control signals together with the control data to provide the output signals.

15 . The system according to claim 14 , wherein the user interface is employable to modify the control data stored by the programmable processor control module.

16 . The system according to claim 14 , wherein the user interface includes a graphic display to visually present a plot of a target patient temperature adjustment rate based on stored control data.

17 . The system according to claim 16 , wherein the graphic display is operable to display a plot of a sensed patient temperature in corresponding time relation to the plot of the target patient temperature adjustment rate.

18 . The system according to claim 17 , wherein the graphic display is operable to display a plot of a sensed temperature of the circulated fluid and a sensed temperature of the blood pumped through the second volume of the thermal exchange module in corresponding time relation to the plot of the target patient temperature adjustment rate.

19 . The system according to claim 14 , wherein the programmable processor control module is operable to store at least two protocols comprising corresponding, different control data, and wherein the user interface is employable by a user to select either of the at least two protocols for use by the programmable processor control module in generating the user control signals.

20 . The system according to claim 12 , wherein the control data for a first phase of the plurality of different temperature control phases comprises at least one of a target patient temperature and a target blood temperature.

21 . The system according to claim 20 , wherein the control data for the first phase of the plurality of different temperature control phases further comprises a duration measure.

22 . The system according to claim 20 , wherein the control data for a second phase of the plurality of different temperature control phases comprises a duration measure and at least one of the target patient temperature and the target blood temperature.

23 . The system according to claim 22 , wherein the control data for a third phase of the plurality of different temperature control phases comprises at least one of the target patient temperature and the target blood temperature.

Continuity (4)

References Cited (400)