Hyperthermia, system, method, and components

• US 20110125232A1
• Filed: 10/09/2010
• Published: 05/26/2011
• 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
• Granted Patent: US 9,737,672 B2
• Time in Patent Office: Days
• US Class Current: 607/105
• 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 process for hyperthermia treatment for an anatomical portion of a body:

comprising,

(a) providing treatment fluid;

(b) heating the treatment fluid to a temperature just a few degrees above physiological normative for the body to be treated;

(c) causing fluid flow for the heated fluid to the anatomical portion of the body to be treated and from that body portion;

(d) causing the fluid to flow from the body to be treated in a continuous enclosed path to where the fluid is heated and back to and from the body to be treated until the treatment procedure is terminated; and

(e) causing the fluid to flow at an operator set rate.

2. The process for hyperthermia treatment for an anatomical portion of a body of claim 1 further including,

(a) controlling the process to continuously monitor the fluid temperature and flow rate as well as detecting air and purging it.

3. 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 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 predetermined temperature not to exceed a physiological temperature which is just a few degrees above normative for the body; and

(f) said predetermined fluid flow rate not to exceed 750 ml/min.

4. The hyperthermia system of claim 3;

wherein said fluid flow tubing means is included as part of a single use disposable set means.

5. The hyperthermia system of claim 3;

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

6. The hyperthermia system of claim 3:

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

7. The hyperthermia system of claim 3;

wherein said fluid processing means further includes;

(a) first ultrasonic air detector means proximate an inlet for fluid to said fluid flow processing means and second ultrasonic air detector means proximate an outlet for fluid from said fluid processing means to detect and facilitate substantial elimination of air from the fluid;

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

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

8. The hyperthermia system of claim 3;

wherein the fluid to be processed may be either human blood or crystalloid.

9. 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.

10. 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.

11. A process for hyperthermia treatment for a body:

comprising,

(a) providing treatment fluid;

(b) heating the treatment fluid to a predetermined temperature;

(c) causing fluid flow for the heated fluid;

(d) causing the fluid to flow either;

(i) through a first enclosed path to and through the body to be treated in a continuous enclosed path to where the fluid is heated and back to and from the body to be treated until the treatment procedure is terminated;

or

(ii) through a second enclosed path from where the fluid is heated and back to and through where the fluid is heated until the fluid is heated to a predetermined temperature; and

(e) selectively diverting the fluid flow into either said first enclosed path or said second enclosed path.

12. The process of claim 11 including selecting said second fluid path during slack time.