Apparatuses and processes for whole-body hyperthermia

• US 6,264,680 B1
• Filed: 01/22/1999
• Issued: 07/24/2001
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Thermasolutions
• Original Assignee: Viacirq Incorporated
• Inventors: Ash, Stephen R.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/235,449
• Time in Patent Office: 914 Days
• Field of Search: 604/4-6, 604/507, 604/27, 604/28, 604/113, 604/114, 604/6.13, 210/321.6, 210/321.71
• US Class Current: 607/106
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/26 and internal elements which are moving
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3493 using treatment agents in suspension
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Apparatuses for use in whole body hypothermia include a high-flow hyperthermia circuit coupled to a low-flow dialysis circuit in a manner which reduces tensioning of membranes in the dialyzer of the dialysis circuit. The arrangement thereby allows proper membrane movement to assist in mixing a sorbent suspension circulated on the sorbent side of the dialyzer. Additional dialysis apparatuses include advantageous disposable packs including the dialyzer, sorbent heat exchangers arranged to cooperate with heating elements on base units of the apparatuses, and adaptations for very high flow rates useful in the hyperthermic treatment of cancers.

Claims

1. An apparatus for use in whole body hyperthermia treatment of a patient, comprising:

a high-flow hyperthermia circuit equipped to circulate blood therethrough at a rate of at least 1500 ml/min, said high-flow hyperthermia circuit including a blood access line for drawing blood from a patient, a pump, a heat exchanger for heating the blood to a temperature of at least 40°

C., and a blood return line for returning the blood to the patient after heating in the heat exchanger;

a low-flow dialysis circuit equipped to circulate blood therethrough at a rate of 200 to 800 ml/min, said low-flow dialysis circuit being coupled to the hyperthermia circuit and effective to divert from said hyperthermia circuit a portion of the blood circulating therein, said low-flow dialysis circuit including;

a blood inflow line having a first end connected to the hyperthermia circuit, for diverting blood into said dialysis circuit from said hyperthermia circuit;

a dialyzer having a blood side and a sorbent side separated by dialysis membranes, said membranes being compliantly formed;

means for applying alternating negative pressure and positive pressure on said sorbent side of said dialyzer;

a blood inlet to said blood side of said dialyzer, a second end of said blood inflow line being connected to said blood inlet;

a blood outlet from said blood side of said dialyzer;

a blood outflow line having a first end connected to said blood outlet, and a second end connected to said hyperthermia circuit;

a sorbent circuit for circulating a sorbent suspension through said sorbent side of said dialyzer; and

wherein said apparatus is configured such that during operation of said high-flow hyperthermia circuit and said low-flow dialysis circuit, said dialyzer membranes expand and compress in response to said alternating negative pressure and positive pressure on said sorbent side of said dialyzer, so as to circulate and agitate a sorbent suspension in said sorbent side whereby effective mixing of said sorbent suspension is maintained.

2. The apparatus of claim 1, which also includes:

a heat exchanger in the dialysis circuit, for heating heating the sorbent suspension.

3. The apparatus of claim 2, wherein the blood inflow line is connected to the high-flow hyperthermia circuit at a location downstream of the blood outflow line.

4. The apparatus of claim 3, wherein the blood inflow line and the outflow line are connected to the hyperthermia circuit on opposed sides of the pump.

5. The apparatus of claim 3, wherein the sorbent suspension includes precipitated calcium phosphate, water, and a particulate surface adsorptive agent.

6. The apparatus of claim 5, wherein said surface adsorptive agent is carbon.

7. The apparatus of claim 6, wherein said expansion and contraction of said membranes causes circulation of said blood in said low-flow dialysis circuit.

8. A process for preparing a sorbent suspension, comprising

combining an aqueous solution having dissolved calcium ions with an aqueous solution having dissolved phosphate ions, wherein said combining is in the presence of a powdered surface adsorptive agent so as to form precipitated calcium phosphate both on the adsorptive agent and freely in the suspension, wherein said process comprises

(a) combining water, activated charcoal powder and a flow-inducing agent;

(b) adding separate solutions containing, respectively, dissolved calcium chloride and dissolved disodium phosphate, to the product of step (a);

(c) agitating the product of step (b);

(d) adding a sodium, calcium, magnesium and potassium-loaded cation exchange resin to the product of step (c);

(e) agitating the product of step (d);

(f) adding sodium bicarbonate powder to the product of step (e); and

(g) agitating the product of step (f).