Hyperthermia, system, method and components

• US 7,819,835 B2
• Filed: 08/07/2007
• Issued: 10/26/2010
• Est. Priority Date: 08/07/2007
• Status: Active Grant

• Current Assignee: Belmont Instrument, LLC
• Original Assignee: Belmont Instrument Corporation
• Inventors: Gildersleeve, Michael, Landy, John, Tseng, Yeu Wen Peter
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/890,577
• Publication Number:
  US 20090043256A1
• Time in Patent Office: 1,176 Days
• Field of Search: 604/291, 604/6.13, 604/113, 604/21, 604/96, 606/24, 606/27, 606/28
• US Class Current: 604/6.13
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/36223 the cassette being adapted for heating or cooling the blood
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

An IV pole mountable, therapeutic infusate processing device is incorporated into a hypothermia system to receive therapeutic fluid(s), such as normal saline, peritioneal dialysis solution, or other crystalloid solution, to heat such therapeutic fluid(s) a few degrees centigrade above normal body temperature and to direct the resulting heated infusate to and through a selected anatomical portion of a patients body to raise the temperature of that body portion so as to affect any cancerous or other tumors that may be located therein. The processing device is provided with touch screen controls and visual indicators to facilitate its proper use; while the system further includes temperature and pressure sensors to monitor the hyperthermia processing to insure patient safety.

Claims

1. A hyperthermia system for providing fluid for a body comprising;

(a) a fluid processing device including a fluid heater and a fluid pump;

(b) fluid flow tubing providing a fluid flow path to and through said fluid processing device for subsequent flow to the body and from the body back to said fluid processing device;

(c) said fluid pump to provide a predetermined fluid flow rate that is not too excessive to the body;

(d) said fluid heater comprising an electro magnetic inductive fluid heating device to heat the fluid to a temperature not to exceed a temperature which is just a few degrees centigrade above normothermic for the body.

2. The hyperthermia system of claim 1;

wherein said predetermined fluid flow rate is not to exceed 750 ml/min.

3. The hyperthermia system of claim 1;

wherein said fluid pump is a roller-type peristaltic volumetric pump.

4. The hyperthermia system of claim 1:

wherein said fluid processing device is of a size and weight that permits it to be mounted on a conventionally available standard IV pole.

5. The hyperthermia system of claim 1;

wherein said fluid processing device further includes;

(a) a first ultrasonic air detector proximate an inlet for fluid to said fluid flow processing device and a second ultrasonic air detector proximate an outlet for fluid from said fluid processing device to substantially eliminate air from the fluid;

(b) pressure control mechanism to facilitate pressure control for the fluid passing through said fluid processing device; and

(c) touch screen type computer control co-acting with said first and second air detectors and said pressure control mechanism as well as with temperature sensors, for sensing fluid temperature just before the fluid is subjected to heat from said fluid heater and just after the fluid has been heated by said fluid heater, for continuous real time temperature monitoring and to otherwise facilitate fluid processing through said fluid processing device.

6. The hyperthermia system of claim 1;

wherein the fluid to be processed may be human blood, crystalloid or a therapeutic fluid such as chemotherapy solution.

7. The hyperthermia system of claim 1;

wherein said fluid flow tubing is included as part of a single use disposable set which also includes a heat exchanger configured and positioned to co-act with said electro magnetic inductive fluid heating device to heat fluid during the flow of fluid through said fluid processing device.

8. A hyperthermia system for providing fluid for a body:

comprising;

(a) a fluid processing device including a fluid heater and a fluid pump;

(b) fluid flow tubing providing a first fluid flow path to and through said fluid processing device for subsequent flow to the body and from the body back to said fluid processing device;

(c) said fluid pump to provide a predetermined fluid flow rate;

(d) said fluid heater heating the fluid to a predetermined temperature;

(e) said fluid flow tubing providing a second fluid flow path back to and through said fluid processing device; and

(f) a fluid path diversion control for directing the fluid into either said first path or said second path (g) said fluid heater comprising an electro magnetic inductive fluid heating device to heat the fluid to a temperature not to exceed a temperature which is just a few degrees centigrade above normothermic for the body.

9. A hyperthermia system for providing fluid for a body:

comprising;

(a) fluid processing means for processing a predetermine fluid, including fluid heating means to heat the fluid and a fluid pump means to pump the fluid through fluid passage means;

(b) fluid flow tubing means providing first fluid passage means to and through said fluid processing means for subsequent flow to the body and from the body back to said fluid processing means;

(c) said fluid pump means providing a predetermined fluid flow rate;

(d) said fluid heater heating means heating the fluid to a predetermined temperature;

(e) said fluid flow tubing means providing second fluid flow passage means back to and through said fluid processing means; and

(f) fluid path diversion control means for directing the fluid into either said first passage means or said second passage means (g) said fluid heater comprising an electro magnetic inductive fluid heating device to heat the fluid to a temperature not to exceed a temperature which is just a few degrees centigrade above normothermic for the body.

10. The process of claim 9 including selecting said second fluid path during slack time.

11. A hyperthermia system for providing fluid for a body:

comprising;

(a) fluid processing means for processing a fluid, including

(1) electro magnetic inductive fluid heating means for heating the fluid;

(2) fluid passage means for directing the fluid when being pumped to and through said fluid processing means for subsequent flow to a body and from the body back to said fluid processing means; and

(2) fluid pump means for pumping the fluid through said fluid passage means;

(b) fluid flow tubing means for providing said fluid passage means

(c) said fluid pump means providing a predetermined fluid flow rate;

(d) said fluid heater heating means heating the fluid to a predetermined temperature; and

(e) said predetermined temperature not to exceed a physiological temperature which is just a few degrees above normative for the body.

12. The hyperthermia system of claim 11;

wherein said disposable set means also includes heat exchanger means configured and positioned to co-act with said fluid heater means to heat the fluid during the flow of the fluid through the fluid processing means.