Hyperthermia method and apparatus

• US 6,827,898 B1
• Filed: 02/26/2002
• Issued: 12/07/2004
• Est. Priority Date: 05/25/1999
• Status: Expired due to Term

• Current Assignee: Thermasolutions
• Original Assignee: Viacirq Incorporated
• Inventors: Rainier, Brad, Keeling, Glenn, Fausset, Michael, Clupper, Marc G.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/979,640
• Time in Patent Office: 1,015 Days
• Field of Search: 604/4.01, 604/6.01, 604/6.09, 604/6.11, 604/6.1, 604/6.13, 604/6.16, 604/19, 604/27, 604/30, 604/31, 604/65-67, 604/113, 604/114, 604/122, 604/123, 604/131, 604/151, 604/167.01, 604/167-3-1, 604/523, 604/264, 422/44, 422/46, 422/82-2-, 422/105, 422/107-9, 422/113, 601/3, 606/27, 607/104-6, 607/107, 607/108-114, 417/15, 417/18, 417/20, 417/22, 165/200, 165/201, 165/279, 165/281-83, 165/287-88, 165/296, 210/634, 210/739, 210/741, 210/742, 210/767, 210/85, 210/87, 210/90, 210/175-6, 210/181, 210/252, 210/348, 210/416.1, 210/502.1
• US Class Current: 422/46
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

A method and device for extracorporeal treatment of a patient by heating the patient'"'"'s blood and/or a regional anatomic area which utilizes an optional hemodialysis machine capable of heating the fluids to 48° C., an optional parallel plate dialyzer together with a sorbent-based detoxifier, a tubular heat exchanger and a high flow positive displacement puma-in addition to various probes and catheters. The present invention also includes a disposable tubing set for directing fluids used in extracorporeal hyperthermia procedures. The tubing set contains a fluid reservoir, accommodates the positive displacement pump, and includes a heat exchanger for heating blood or fluid. The specific improvements in extracorporeal heating afforded by this system inhere in the combined high flow of the pump and the high temperature—up to 52° C.—achievable in the heat exchanger, which together provide unprecedented speed and efficiency in the administration of hyperthermia treatments in extracorporeal blood or circuits. Computer controlled alarms provide enhanced safety monitoring. The prepackaged sterilized fluid handling system enhances safety and may be configured to respond to a particular indication.

Claims

1. A method for implementing hyperthermia comprising:

creating a fluid circuit external to an animal or patient for which hyperthermia is indicated with at least one catheter;

positioning a pump in fluid communication with said at least one catheter;

pumping said fluid at approximately 2400 ml per minute through a heat exchanger, said heat exchanger having a fluid reservoir for maintaining fluid in the reservoir at approximately 52°

C.;

providing at, least one each of a pressure sensor, a temperature sensor, and an alarm; and

regulating a desired patient temperature with a computer and user interface means that receives signals from the pressure sensor and the temperature sensor;

establishing a desired patient temperature in as little as twenty minutes.

2. The method according to claim 1 further including the step of detecting when said alarm is activiated.

3. The method according to claim 2 wherein said heat exchanger is a tubular heat exchanger.

4. The method according to claim 1 further comprising fluidly interconnecting the heat exchanger to a 1500 watt heater and a 1200 watt cooler.

5. The method according to claim 1 further comprising administering at least one potentiable pharmaceutically active agent in conjunction with the hyperthermia thus induced.

6. The method according to claim 1 wherein said catheter is equipped with a bypass valve.

7. A method for implementing hyperthermia comprising:

creating a first fluid circuit including;

a supply of a first fluid; and

a heater for heating a flow of said first fluid to an elevated temperature, wherein said heater establishes the elevated temperature of approximately 52°

C.;

creating a second fluid circuit including;

an inlet for a flow of a second fluid having a temperature which is lower than the elevated temperature of the first fluid, said inlet being adapted to be placed in fluid communication with a patient;

placing an outlet for the flow of the second fluid in fluid communication with the subject;

pumping the first fluid at a flow rate of substantially 2400 ml per minute with a pump; and

raising the temperature of the second fluid for delivery to the subject by using a heat exchanger in fluid communication with each of the first and second fluid circuits and placing the flow of the first fluid in heat exchange relationship with the flow of the second fluid; and

regulating the first and second fluid circuits with a control system in order to establish a desired treatment temperature for the patient.

8. The method according to claim 7 further comprising the step of circulating the second fluid, which is a fluid other than blood, into and out of a cavity within the patient to create a hyperthermic state in tissue surfaces within said cavity.

9. The method according to claim 8 wherein said circulating step further comprises providing the second fluid only to an anatomically isolated area.

10. The method according to claim 9 further comprises withdrawing the second fluid before the temperature of the second fluid falls below 42°

C.

11. The method according to claim 7 wherein said pumping step further comprises heating primarily only the second fluid in an anatomically isolated area, wherein said second fluid is blood.

12. The method according to claim 7 wherein said heat exchanger is a tubular heat exchanger.

13. The method according to claim 7 further comprising fluidly interconnecting said heat exchanger to a 1500 watt heater and a 1200 watt cooler.

14. The method according to claim 7 further comprising administering at least one potentiable pharmaceutically active agent in conjunction with the hyperthermia thus induced.