Perfusion hyperthermia treatment system and method

• US 6,413,233 B1
• Filed: 01/10/2000
• Issued: 07/02/2002
• Est. Priority Date: 08/18/1995
• Status: Expired due to Fees

• Current Assignee: First Circle Medical, Inc.
• Original Assignee: Biothermics, Inc.
• Inventors: Norgaard, Clark B., Miller, Michael D., Sites, Jeffrey P., Roman, Thomas A., Glassel, Philip R., Ziebarth, Dale J.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/480,088
• Time in Patent Office: 904 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.13, 604/28, 604/500, 604/503, 604/27, 604/113-114, 604/65-67, 601/1, 601/3, 606/27, 600/300, 600/301, 600/306, 600/363, 600/366, 600/504, 210/739, 210/742, 210/252, 210/259-261, 210/256, 210/258, 210/257--25, 210/282, 210/321.6, 422/44, 422/46, 422/82, 422/12, 128/905, 128/898, 128/923, 128/924, 738/631.1, 165/200, 165/201, 165/205, 165/177, 165/287-289, 165/293, 706/45-47, 706/52, 706/55, 706/924, 706/932, 706/934, 714/25-26, 714/37-43, 714/418, 714/819, 714/822-824
• US Class Current: 604/6.13
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 706/924 Medical

Abstract

Method and apparatus to automatically monitor and control a perfusion hyperthermia treatment using a system including one or more programmed computers, and mechanical and sensor subsystems. The system includes a fluid path between a patient and an external fluid-treatment subsystem, wherein control of the external fluid-treatment subsystem includes feedback from sensors coupled to the patient. The resulting integrated system provides automated monitoring and control of the patient, the external fluid-treatment subsystem, and the treatment. In one embodiment, the fluid passing between the patient and the external fluid-treatment subsystem is blood. In one embodiment, an apparatus and method are provided for using a computerized system for a perfusion hyper/hypothermia treatment of a patient which obtains a body fluid having a temperature. A plurality of temperature signals representative of temperatures at each of a plurality of patient locations on or within the patient are coupled to the computer system. Measured temperatures are compared to a set of stored parameters in the computer system to generate a comparison value which controls a change in the temperature of the body fluid. The body fluid is then perfused into the patient to either warm, cool, or maintain the current temperature of the patient. In one such embodiment, the body fluid is blood withdrawn from the patient. In another such embodiment, the body fluid is saline.

Claims

1. A method for using a computerized system for a perfusion hyper/hypothermia treatment of a patient comprising:

obtaining physiological fluid having a temperature;

coupling a plurality of temperature signals to the computerized system, each one of the temperature signals representative of a temperature at a separate one of a plurality of patient locations on or within the patient;

generating at least one temperature value representative of each one of the temperatures;

comparing the at least one temperature value to a set of stored parameters in the computerized system to generate a comparison value;

controlling a change in the temperature of the physiological fluid based on the comparison value;

perfusing the physiological fluid into the patient;

measuring a time difference between a start of treatment time and a current time; and

wherein the step of comparing further includes comparing the time difference to a stored parameter in the computerized system.

2. The method according to claim 1, wherein the physiological fluid is blood withdrawn from the patient.

3. The method according to claim 1, further including:

calculating, with the computerized system, at least one temperature differential value based on the temperature values of two or more patient locations; and

wherein the step of comparing further includes comparing the temperature differential value to a stored parameter in the computerized system.

4. A method for using a computerized system for a perfusion hyper/hypothermia treatment of a patient comprising:

obtaining physiological fluid having a temperature;

coupling a plurality of temperature signals to the computerized system, each one of the temperature signals representative of a temperature at a separate one of a plurality of patient locations on or within the patient;

generating at least one temperature value representative of each one of the temperatures;

comparing the at least one temperature value to a set of stored parameters in the computerized system to generate a comparison value;

controlling a change in the temperature of the physiological fluid based on the comparison value;

perfusing the physiological fluid into the patient;

calculating, with the computerized system, at least one rate of temperature change value based on a time difference and the temperature values; and

wherein the step of comparing further includes comparing the rate of temperature change value to a stored parameter in the computerized system.

5. The method according to claim 4, further including:

calculating, with the computerized system, at least one temperature differential value based on the temperature values of two or more patient locations; and

wherein the step of comparing further includes comparing the temperature differential value to a stored parameter in the computerized system.

6. A method for using a computerized system for a perfusion hyper/hypothermia treatment of a patient comprising:

obtaining physiological fluid having a temperature;

coupling a plurality of temperature signals to the computerized system, each one of the temperature signals representative of a temperature at a separate one of a plurality of patient locations on or within the patient;

generating at least one temperature value representative of each one of the temperatures;

comparing the at least one temperature value to a set of stored parameters in the computerized system to generate a comparison value;

controlling a change in the temperature of the physiological fluid based on the comparison value;

perfusing the physiological fluid into the patient;

eliciting and receiving checklist input from a user; and

controlling operation of the computerized system based on the checklist input from the user.

7. A method for using a computerized system for a perfusion hyper/hypothermia treatment of a patient comprising:

obtaining physiological fluid having a temperature;

coupling a plurality of temperature signals to the computerized system, each one of the temperature signals representative of a temperature at a separate one of a plurality of patient locations on or within the patient;

generating at least one temperature value representative of each one of the temperatures;

comparing the at least one temperature value to a set of stored parameters in the computerized system to generate a comparison value;

controlling a change in the temperature of the physiological fluid based on the comparison value;

perfusing the physiological fluid into the patient;

repeatedly verifying correct operation of the computerized system with a self-test program.

8. A method for using a computerized system for a perfusion hyper/hypothermia treatment of a patient comprising:

obtaining physiological fluid having a temperature;

coupling a plurality of temperature signals to the computerized system, each one of the temperature signals representative of a temperature at a separate one of a plurality of patient locations on or within the patient;

generating at least one temperature value representative of each one of the temperatures;

comparing the at least one temperature value to a set of stored parameters in the computerized system to generate a comparison value;

controlling a change in the temperature of the physiological fluid based on the comparison value;

perfusing the physiological fluid into the patient;

repeatedly verifying correct coupling of the computerized system to external components with a self-test program.

9. A computerized perfusion hyper/hypothermia treatment method comprising:

providing a physiological fluid having a temperature;

at each of a plurality of times, receiving one or more temperature values each representative of a temperature at a patient location on or within a patient;

comparing the received temperature values to a stored temperature-versus-time profile;

controlling a change in the temperature of the physiological fluid based on the profile; and

perfusing the physiological fluid into the patient.

10. The method according to claim 9, further comprising:

eliciting and receiving checklist input from a user; and

controls operation of the method based on the checklist input.

11. The method according to claim 9, wherein the physiological fluid is blood withdrawn from the patient, and wherein the blood is perfused back into the patient at a different temperature from that when it was withdrawn based on the profile.

12. The method according to claim 9, further comprising:

pumping the physiological fluid at a flow rate that is based on the stored profile.

13. The method according to claim 9, further comprising:

generating a time-difference value representative of a time difference between a start of treatment time and a current time, wherein the comparing the set of temperature values to the temperature-versus-time profile further includes selecting among a set of stored parameters based on the time-difference value.

14. The method according to claim 9, further comprising:

a self-test program that runs on the computer system to verify correct operation of a computer system that controls the comparing the received temperature values to the stored temperature-versus-time profile.

15. The method according to claim 9, further comprising:

mounting a replaceable physiological-fluid heat-exchanger cartridge to a heat-exchanger structure configured to use replaceable heat-exchanger cartridges;

introducing a heat-exchange medium into the heat-exchanger structure; and

circulating the medium in thermal contact with the physiological-fluid heat-exchanger cartridge.

16. The method according to claim 9, further comprising:

mounting a replaceable physiological-fluid pump-interface cartridge having a substantially rigid connector and a physiological-fluid path including a deformable plastic enclosure assembled to the connector to a physiological-fluid pump structure configured to use replaceable pump-interface cartridges to provide mechanical energy to the physiological-fluid-treatment pump interface cartridge, wherein the pump structure and the connector cooperate to provide a predetermined occlusion to the deformable plastic enclosure when the physiological-fluid-pump interface cartridge is attached to the physiological-fluid-pump structure.

17. The method according to claim 9, wherein the physiological fluid is saline.

18. In a perfusion hyper/hypothermia-treatment computer-system used to treat a patient, a method comprising:

holding, in the computer system, a set of stored parameters, the set of stored parameters including a minimum and a maximum temperature parameter, and a minimum and a maximum temperature-rate-of-change parameter;

providing a physiological fluid having a temperature, wherein the physiological fluid is blood withdrawn from the patient;

generating a temperature value representative of temperatures at each of a plurality of patient locations on or within a patient and a temperature-rate-of-change value based on a rate of temperature change of one of the temperatures;

comparing, in the computer system, the temperature value to the minimum and maximum temperature parameters in the computer system to generate temperature comparison values;

comparing, in the computer system, the temperature-rate-of-change value to the minimum and maximum temperature-rate-of-change parameters in the computer system to generate rate comparison values;

exchanging heat with the physiological fluid and controlling a change in the temperature of the physiological fluid based on the temperature and rate comparison values; and

perfusing the physiological fluid into the patient.

19. The method according to claim 18, further comprising:

pumping the physiological fluid at a pumping rate controlled by the computer system whereby the physiological fluid is pumped to be perfused into the patient after a temperature change has been affected.

20. The method according to claim 18, wherein computer system is operatively coupled to a heat exchanger adapted to accept a replaceable heat exchanger cartridge, wherein the heat exchanger includes a heat-exchanger structure configured to accept a replaceable heat-exchanger cartridge, the method further comprising:

removing a first replaceable heat-exchanger cartridge; and

inserting a second replaceable heat-exchanger cartridge into the heat-exchanger structure; and

introducing a heat-exchange medium into the heat-exchanger structure and circulating the medium around or through the second heat-exchanger cartridge.

21. The method according to claim 18, further comprising:

comparing a plurality of different-time received temperature values to a stored temperature-versus-time profile and generating time-profile comparison values, wherein the exchanging heat with the physiological fluid and controlling a change in the temperature of the physiological fluid is further based on the time-profile comparison values.