Apparatus and method for the extracorporeal treatment of the blood of a patient having a medical condition

• US 5,391,142 A
• Filed: 07/29/1992
• Issued: 02/21/1995
• Est. Priority Date: 07/29/1992
• Status: Expired due to Term

• Current Assignee: First Circle Medical, Inc.
• Original Assignee: Organetics Limited (IQUniverse, Inc.)
• Inventors: Chen, Wei, Sites, Jeffrey P.
• Primary Examiner(s): Rimell, Sam
• Application Number:
  US07/922,034
• Time in Patent Office: 937 Days
• Field of Search: 604/4, 604/5, 604/6, 604/19, 604/27, 604/28, 604/30, 604/31
• US Class Current: 604/6.13
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36223 the cassette being adapted for heating or cooling the blood
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/226 the blood flow through the rotating member having mainly radial components
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: A61M 60/419 the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61M 60/849 : Disposable parts

Abstract

Apparatus and a method for performing extracorporeal treatment of a patient'"'"'s blood for various conditions. The apparatus includes means by which an extracorporeal blood circuit is defined. Such a blood flow circuit includes first means for cannulating a vein of a patient to define a blood egress point and second means for cannulating an artery of the patient to define a blood ingress point. A discontinuous conduit is provided to interconnect, in part, the first and second cannulating means. The apparatus also includes a module which includes a conduit portion. The module integrates a number of components into a single unit, and the conduit portion thereof is able to be interposed in the discontinuity in the discontinuous conduit to complete the blood flow circuit. The various components which are connected in the conduit portion include a pump, a device such as a heat exchanger to regulate the temperature of blood flowing through the conduit portion, and means for sensing the temperature, pressure, and flow rate of the blood passing through the conduit portion. In some applications, an oxygenator can also be included. A control console is provided to enable pressure and flow rate of the blood passing through the conduit portion to be controlled. Similarly, appropriate controls can be employed to regulate the temperature, and, when an oxygenator is included, a controller would, typically, be provided for the oxygenator also.

Claims

1. A method for treating a patient for acquired immune deficiency syndrome (AIDS), comprising the steps of:

(a) cannulating the patient for extracorporeal blood circulation wherein a blood flow circuit is defined between a first point of cannulation at a blood vessel of a patient and a second point of cannulation at a different blood vessel of the patient;

(b) pumping the patient'"'"'s blood through the circuit with a motor driven pump;

(c) measuring the motor speed of said motor driven pump, the rate of flow of blood through the circuit and the fluid temperature and pressure within said circuit;

(d) heating the patient'"'"'s blood to a first elevated temperature for a relatively short period of time as it passes through the circuit;

(e) subsequently heating the patient'"'"'s blood to a second elevated temperature, lower than said first elevated temperature, for a more extended period of time as it passes through said flow circuit; and

(f) adjusting the motor speed as a function of a deviation of one of current motor speed, said fluid pressure, said fluid temperature and said rate of flow from a desired set-point value.

2. A method in accordance with claim 1 wherein the patient'"'"'s blood is heated to a first elevated temperature of between 42°

C. to 48°

C. for a period of about one to two hours.

3. A method in accordance with claim 2 wherein the patient'"'"'s blood is heated to a second elevated temperature of between 37°

C. to 39°

C. for a period of about two hours.

4. A method in accordance with claim 3 wherein heating of the patient'"'"'s blood to said first elevated temperature and to said second elevated temperature are sufficient to raise the temperature of the patient'"'"'s bodily tissues to a temperature of above 37°

C.

5. A method of performing hyperthermia treatment of a patient'"'"'s blood to treat for various maladies, comprising the steps of:

(a) cannulating the patient for extracorporeal blood circulation wherein a blood flow circuit is defined between a first point of cannulation of a blood vessel in a patient and a second point of cannulation of a different blood vessel a patient;

(b) pumping the patient'"'"'s blood through the circuit with a motor driven pump;

(c) measuring the motor speed of said motor driven pump, the rate of flow of blood through the circuit and the fluid pressure and temperature within said circuit;

(d) heating the patient'"'"'s blood to a first elevated temperature for a relatively short period of time as it passes through the circuit;

(e) subsequently maintaining the patient'"'"'s blood at a second elevated temperature, lower than said first elevated temperature, for a more extended period of time as it passes through said flow circuit in order to elevate the temperature of the patient'"'"'s bodily tissue above a normal level; and

(f) adjusting the motor Speed as a function of a deviation of one of current motor speed, said fluid pressure, said fluid temperature and said rate of flow from a desired set-point value.

6. Blood treatment apparatus comprising in combination:

(a) a base unit including

(i) chassis-means for supporting one of a plurality of disposable modules, said chassis means including a console having operator adjustable controls and indicators thereon;

(ii) a blood pump driver disposed in said console;

(b) said disposable modules including;

(i) a blood pump having an inlet and an outlet;

(ii) heat exchanger means having an inlet and an outlet, said heat exchanger means inlet being coupled in circuit with said blood pump outlet for delivering heat energy to blood being pumped by said blood pump;

(iii) a plurality of sensing probes coupled in a series flow relation circuit with said heat exchanger means outlet for sensing at least one of fluid pressure, blood flow rate and temperature of said blood flowing in said circuit; and

(iv) means for coupling a patient'"'"'s vascular system to said inlet of said blood pump and to said series flow relation circuit;

(c) means for removably coupling said plurality of sensing probes to said indicators; and

(d) means for coupling said operator adjustable controls and said blood pump to said blood pump driver.

7. The blood treatment apparatus and in claim 6 wherein said disposable modules further include blood oxygenating means in series flow relation circuit for introducing oxygen into the blood flowing through said circuit.

8. The blood treatment apparatus as in claim 6 wherein said disposable modules further include a bypass circuit for selectively shunting said means for coupling the patient'"'"'s vascular system from said series flow relation circuit.

9. The blood treatment apparatus as in claim 7 wherein said disposable modules further include a bypass circuit for selectively shunting said means for coupling the patient'"'"'s vascular system from said series flow relation circuit.

10. The blood treatment apparatus as in either claim 6 or claim 7 wherein said disposable modules further include a particulate filter in said series flow relation circuit.

11. The blood treatment apparatus as in claim 6 wherein said means for coupling a patient'"'"'s vascular system includes means for cannulating first and second blood vessels of the patient.

12. The apparatus as in claim 11 wherein said blood vessels include two separate veins.

13. The apparatus as in claim 11 wherein said blood vessels include an artery and a vein.

14. The apparatus as in claim 6 and further including:

(a) means for regulating the temperature of blood flowing in said series flow relation circuit; and

(b) means for selectively controlling said blood pump and said temperature regulating means in response to temperature, pressure and blood flow rates sensed by said plurality of sensing probes.

15. A method for treating a patient for acquired immune deficiency syndrome (AIDS) comprising the steps of:

(A) providing apparatus for subjecting the patient to hyperthermia, said apparatus including;

(a) a base unit including

(i) chassis means for supporting one of a plurality of disposable modules, said chassis means including a console having operator adjustable controls and indicators thereon;

(ii) a blood pump driver disposed in said console;

(b) disposable modules including

(i) a blood pump having an inlet and an outlet;

(ii) heat exchanger means having an inlet and an outlet, said heat exchanger means being coupled in circuit with said blood pump outlet for delivering heat energy to blood being pumped by said blood pump;

(iii) a plurality of sensing probes coupled in a series flow relation circuit with said heat exchanger outlet for sensing at least one of fluid pressure, blood flow rate and temperature of said blood flowing in said circuit; and

(iv) means for coupling a patient'"'"'s vascular system to said inlet of said blood pump and to said series flow relation circuit;

(c) means for removably coupling said plurality of sensing probes to said indicator; and

(d) means for coupling said operator adjustable controls and said blood pump to said blood pump driver;

(B) cannulating the patient'"'"'s vascular system to create a blood egress point and a blood ingress point;

(C) coupling said blood pump to said blood egress point and said series flow relation circuit to said blood ingress point;

(D) driving said blood pump to circulate blood through said heat exchanger means while delivering heat energy to said heat exchanger for a time sufficient to elevate the patient'"'"'s blood temperature to a point lethal to viruses in the blood; and

(E) extracting heat energy from said heat exchanger to return the patient'"'"'s blood temperature to a normal range.

16. A method of performing hyperthermia treatment of a patient'"'"'s blood to treat for various maladies, comprising the steps of:

(A) providing apparatus for subjecting the patient to hyperthermia, said apparatus including

(a) a base unit having

(i) chassis means for supporting one of a plurality of disposable modules, said chassis means including a console having operator adjustable controls and indicators thereon;

(ii) a blood pump driver disposed in said console;

(b) said disposable modules including

(i) a blood pump having an inlet and an outlet;

(ii) heat exchanger means having an inlet and an outlet, said heat exchanger means being in circuit with said pump outlet for delivering heat energy to blood being pumped by said blood pump;

(iii) a plurality of sensing probes coupled in a series flow relation circuit with said heat exchanger outlet for sensing at least one of fluid pressure, blood flow rate and temperature of said blood flowing in said circuit;

(iv) blood oxygenization means disposed in said series flow relation circuit for introducing oxygen into the blood traversing said circuit; and

(v) means for coupling a patient'"'"'s vascular system to said inlet of said blood pump and to said series flow relation circuit;

(c) means for removably coupling said plurality of sensing probes to said indicators; and

(d) means for coupling said operator adjustable controls and said blood pump to said blood pump driver;

(B) cannulating the patient'"'"'s vascular system to create a blood egress point and a blood ingress point;

(C) coupling said blood pump to said blood egress point and said series flow relation circuit to said blood ingress point;

(D) driving said blood pump to circulate blood through said heat exchanger means and said blood oxygenization means while delivering heat energy to said heat exchanger means for a time sufficient to elevate the patient'"'"'s blood temperature to a point lethal to viruses in the blood; and

(E) extracting heat energy from said heat exchanger to return the patient'"'"'s blood temperature to a normal range.