Hemo-aide

(21) Appl. No.: 10/219,656

(22) Filed: Aug. 14, 2002

(65) Prior Publication Data

US 2003/0040693 Al Feb. 27, 2003

(51) Int. CI.7 A61M 37/00; A61M 1/00;

A61M 1/36; G01N 23/12; H01J 37/20

(52) U.S. CI 604/6.08; 604/4.01; 604/28;

422/44; 250/432 R; 250/428; 250/455.11;

250/435; 250/436

(58) Field of Search 604/4.01, 5.01,

604/5.02, 5.04, 6.08, 6.11, 6.15, 6.16, 19, 20, 21, 28, 30, 35, 500; 128/897, 898; 422/44, 99, 104, 122, 24; 210/252, 256, 257.1, 258-60, 542; 607/1-3, 81, 87, 88, 90, 94, 104-106; 250/428, 432 R, 434^138, 453.11, 454.11, 455.11, 492.1; 435/2, 283.1, 284.1, 286.1, 286.5, 304.1-3

(56) References Cited

U.S. PATENT DOCUMENTS

3,894,236 A 7/1975 Hazelrigg

An apparatus and method for modifying viruses and bacteria in a closed loop system that irradiates the fluid multiple times through the same channel. The apparatus consists of a cuvette, an irradiation station, a peristaltic pump, and a bottle. A plurality of power control switches controls the operation of the apparatus. This includes an on/off power switch, an on/off pump control, and a ultraviolet light control switch. A timer is provided to regulate the time period the cuvette is exposed to the ultraviolet radiation within the irradiation station. A cover is provided to enable the cuvette to be used and exposed to ultraviolet radiation within an enclosed environment.

15 Claims, 2 Drawing Sheets

1

HEMO-AIDE

FIELD OF THE INVENTION

The present invention relates to the ultra violet irradiation 5 of blood apparatus and, more particularly, to the modification of viruses and bacteria in the body without contamination using a unique method and cuvette apparatus.

BACKGROUND AND DESCRIPTION OF THE 10
PRIOR ART

In the past, others have attempted to eradicate viruses and bacteria using a mercury vapor lamp and an irradiation chamber. This combination, however, presented a number of 15 problems. Since the mercury vapor lamp is made with contaminating materials, the irradiation chamber could become contaminated. As a result, this type of lamp has been restricted by the Federal Drug Administration from use in the treatment of fluids in this manner. Also, as the irradiation 20 chamber is permanently secured to the unit, sterilization of the chamber is a very difficult, time consuming task.

In an attempt to overcome this problem, a number of patents have been issued that disclose apparatus and methods for the irradiation of blood or bodily fluids. As listed 25

Of these patents, the most relevant are: U.S. Pat. No. 50 5,770,147 to Muller entitled "Apparatus For The Irradiation of Body Fluids By Ultraviolet Light" ("Muller"); U.S. Pat. No. 5,429,594 to Castle entitled "Extra-Corporeal Blood Access, Sensing, and Radiation Methods And Apparatus" ("Castle"); U.S. Pat. No. 5,304,113 to Sieber entitled 55 "Method of Eradicating Infectious Biological Contaminants" ("Sieber"); and U.S. Pat. No. 5,951,509 to Morris entitled "Blood Product Irradiation Device Incorporating Agitation" ("Morris").

Muller ('147) discloses an apparatus for the irradiation of 60 body fluids by ultraviolet light in a containment. In one embodiment, the containment consists of a cuvette, an adaptor, a drive motor, and a Ultraviolet lamp. The cuvette, upon being filled with blood removed from a patient, is fitted into the containment and engaged with the adaptor. The 65 cuvette is then rotated by the drive motor and exposed to the Ultraviolet radiation uniformly. The cuvette also includes

2

flow baffles to provide additional turbulence to generate a radial flow of the blood towards the Ultraviolet radiation. Upon completion of the radiation, the cuvette is disengaged from the containment, the irradiated blood is removed from the cuvette, and then returned to the patient.

Castle ('594) discloses a method and apparatus for extra corporeal access to blood for analysis and treatment of the blood. In use, the apparatus pumps blood from a patient through an outlet line and then returns the blood back to the patient through an inlet line. During this extra corporeal flow of the blood, the outlet line and the inlet line each have access ports in which the blood may be either analyzed or treated. Any treatment of the blood consists of energy or radiation and includes ultrasonic waves.

Sieber ('113) discloses a method to erradicate infectious biological contaminants such as the human immunodeficiency virus. The method consists of withdrawing the blood from a patient using a pump, adding anti-coagulants to the blood, an occluded vein sensor to prevent or inhibit the generation or existence of bubbles in the flow of the blood, inserting a photosensitizing agent, an irradiation chamber which consists of visible light to activate the photosensitive agent, and then returning the erradicated blood to the patient.

Morris ('509) discloses an apparatus for treating human blood by irradiation. In use, blood is withdrawn from a patient and supplemented by an anti-coagulant solution. The blood is then separated into two portions by a cell separator, such as a centrifuge, with one portion being directed into a bag for irradiation and another portion either being held in storage or returned to the patient. Upon a predetermined volume of blood accumulated into the bag, the bag is placed within an irradiation apparatus. The irradiation apparatus consists of an upper lamp array and a lower lamp array of ultraviolet individual lamps and the bag is placed in the middle of the upper lamp array and the lower lamp array to irradiate the blood prior to being returned to the patient.

The combination of the above patents reveals that there exist several ways to irradiate blood from a patient. Among the common disclosure of these patents is that blood is removed from a patient, the blood is irradiated using ultraviolet light to kill contaminants and viruses, and the irradiated blood is then returned to the patient. Each patent is distinguishable in that it introduces additional steps during this process and/or accomplishes the process in a different manner. However, none of the patents disclose or teach a closed system with the ability to remove contaminated blood from a patient in one channel, effectively irradiate the blood twice using the same cuvette, and then return the irradiated blood back to the patient using the same channel, thereby, providing an effective modification of the viruses and bacteria in the blood in an attempt to eradicate the same. Thus, there is a need and there has never been disclosed an apparatus and method that solves the problems presented by today's devices and is as effective as Applicant's unique invention.

OBJECTS OF THE INVENTION

It is the primary object of the present invention to modify viruses and bacteria in the body in an attempt to eradicate the same. A related object of the present invention is to effectively modify the viruses and bacteria using a minimal number of modalities or processes. Another related object of the present invention is to have a positive impact on the condition. A further related object of the present invention is to reduce the blood count or PCR within the body.

Another object of the invention is to provide an apparatus that uses pure safe ultraviolet light and that is calibrated to