WO1995025551A1

WO1995025551A1 - Blood oxygenating system with improved safety features

Info

Publication number: WO1995025551A1
Application number: PCT/US1994/003186
Authority: WO
Inventors: Gary M. Nath; David Elsley
Original assignee: Mueller Medical International, Inc.
Priority date: 1994-03-24
Filing date: 1994-03-24
Publication date: 1995-09-28
Also published as: AU6524094A

Abstract

The present invention provides enhanced safety features in a system for oxygenating blood. The oxygenating system contains an oxygenating instrument (10) into which is reversibly inserted a disposable canister (11) bearing a patient identification label (13). The oxygenating instrument (10) is equipped with a device for reading the identification label (13). The reading device is coupled with a triggering mechanism that enables the oxygenating instrument (10) only when a properly labeled disposable canister (11) is inserted into the instrument (10).

Description

BLOOD OXYGENATING SYSTEM WITH IMPROVED SAFETY FEATURES

FIELD OF THE INVENTION The present invention pertains to improved safety features in a method for the extra-corporeal oxygenation of blood. The oxygenating apparatus incorporates a labeled disposable blood canister, which when reversibly inserted into the oxygenating apparatus, triggers an enabling mechanism allowing the apparatus to begin the treatment regimen.

BACKGROUND OF THE INVENTION

It has been found that the extra-corporeal administration of ozone, ultraviolet light and heat to animal blood can enhance the animal's immune response when the treated blood is returned to the animal.

U.S. Patent No. 4,968,483, which is incorporated herein by reference, describes an apparatus for treating blood with ozone, ultraviolet light and heat. The apparatus described in U.S. Patent No. 4,968,483 utilizes a blood canister that is reversibly inserted into the oxygenating instrument.

The blood canister of the apparatus is fashioned in the shape of an inverted bottle with the neck sealed off and the bottom comprising a removable, loose-fitting lid. Through a central opening in the lid are positioned a gas feed tube and a temperature monitoring device. The canister is inserted into a complementary shaped receptacle in the oxygenating instrument.

The instrument delivers predetermined quantities of ozone, ultraviolet light and heat to the contents of the blood canister. The canister receptacle in the oxygenating instrument includes a coupling compatible with the canister's gas feed tube for administering the gaseous ozone directly to the blood sample in the blood canister. When the instrument is activated, the ozonizer, the ultraviolet light and the heat source expose the blood sample in the canister to predetermined quantities of ozone, light, and heat.

Following the oxygenation regimen, the treated blood sample is removed from the canister by means of a syringe and injected back into the animal from which it originated by intramuscular or intravenous injection.

The blood canisters are preferably fabricated from high quality polyethylene that is transparent to ultraviolet light. Similarly, the polyethylene material is pyrogen-free and capable of sterilization by irradiation. The canisters are individually wrapped and sterilized by irradiation to render the canisters aseptic.

As with all medical devices exposed to blood, the canisters are potential vehicles for infection by blood-borne viruses such as the AIDS virus . For purposes of patient safety, the canisters are designed to be used for a single patient only followed by prompt disposal .

In addition to possible infection by subsequent use of a non-sterile canister, human error may also put the patient at risk. For example, technicians occasionally label samples illegibly or incorrectly.

Ineffective or incorrect labeling present unacceptable safety hazards as well as various inefficiencies. Perhaps the most hazardous result being mistaken identification of the patient from which the blood sample was taken. For this reason, strict adherence to the most reliable labeling techniques available is essential to ensuring maximum patient safety.

Technicians operating the ozonizing instrument are exposed to unreacted ozone. Ozone is a toxic gas and exposure should be minimized. Accordingly, the ozone source in the instrument should be disabled when a blood canister is not in place and coupled to the ozone source.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 illustrates an embodiment of an oxygenating instrument. Such an instrument includes an ozone source, an ultraviolet light source, and a heat source, and further includes means for reading a label or other patient identification means placed on a reversibly inserted canister.

Figure 2 illustrates an embodiment of the blood canister wherein the identification means comprises a bar code label.

Figure 3 illustrates an embodiment of the blood canister wherein the identification means comprises a magnetically coded label.

THE INVENTION

The present invention provides a means for reducing the likelihood that patients undergoing extra-corporeal blood treatments will be exposed to blood-borne viruses such as the AIDS virus. Similarly, the invention provides a means for ensuring that disposable blood canisters are reliably labeled in a standardized fashion to ensure proper identification of the patient from which the blood sample was drawn. The invention also ' provides a technique for improving worker safety by limiting the amount of ozone discharged into the atmosphere during operation of the instrument. The invention utilizes a two-part identification system involving a labeling or identification means in combination with a reading means. In such an identification system the labeling means and reading means are integrated such that information transcribed into the labeling means can be detected, read, and affirmatively recognized by the reading means. One such example is a bar code identification system incorporating bar code labels on the canisters and a bar code reader in the instrument. Another example is the use of a magnetically coded identification system wherein a magnetically inscribed label is placed on the canister and a magnetic reading means is integrated into the instrument such that the reading means can successfully read the label when the canister is inserted into the instrument for a treatment regimen.

Figure 1 illustrates an embodiment of the instrument (10) that serves as an ozone source, an ultraviolet light source, and/or a heat source. The

Figure further illustrates the reversibly insertable blood canister (11) . In this embodiment the reading means (not shown) is placed below the control panel

(12) and is positioned such that it scans or reads a specific region of the cavity that is filled by the blood canister when it is inserted into the instrument for a treatment regimen. The labeling means (not shown) affixed to the blood canister is positioned such that the labeling means appears within the specific region or within sufficient proximity of the reading means when the canister is inserted into position such that the reading means can successfully detect and read the labeling means and thereby enable the instrument (10) to perform a treatment regimen on the contents of the canister.

Figure 2 illustrates an embodiment of an empty blood canister (11) specifically depicting a bar code labeling means (13) , gas inlet means (14) for administration of ozone gas to the contents of the canister, and heat monitoring means (15) , such as a thermocouple, for monitoring the temperature of the contents of the blood canister. Figure 3 is a variation on Figure 2 wherein the canister is labeled with a magnetically coded label (16) . In an embodiment of the present invention using bar code labels and readers, the instrument (10) is equipped with a bar code reading means and the canister is labeled with a bar code identification means. The two are oriented such that the bar code label on the canister appears within the scanning field or field of view of the bar code reader when the cani«ster is properly positioned within the cavity or receptacle portion of the instrument. The reader automatically reads the bar code label and enables the instrument for a treatment regimen.

Preferably, the reading means is integrated with the ozone source of the instrument by way of an enabling mechanism. When triggered, the enabling mechanism allows the instrument to generate ozone. Thus, for example, the ozone source is enabled only when the bar code reader successfully reads an identifiable bar code label. The instrument is only capable of generating ozone when coupled with a blood canister, thereby reducing the amount of ozone haphazardly escaping into the ambient atmosphere. In yet another embodiment, the blood canisters are labeled with bar code labels strictly corresponding to patient information previously entered into a patient tracking system. According to one such embodiment, patient information is transcribed into a database before the canisters are labeled. When the database has data corresponding to the requisite fields of information, a bar code label is generated and applied to the canister. The bar code reader is coupled with the patient tracking database such that only bar code labels corresponding to completed patient files in the database will enable the instrument. Accordingly, when a properly labeled sample is placed into position in the instrument, the bar code reader scans the label, affirmatively recognizes it as corresponding to an authorized patient file, and then enables the instrument to perform the prescribed oxygenation regimen. The present system can detect and prevent duplicative treatment of a sample or repeated use of the same canister. In such an embodiment, the bar code reader is integrated with the patient tracking database and programmed to identify a labeled canister already exposed to the oxygenation regimen.

Such duplicative readings suggest that the sample has already been treated and does not require additional treatment, or that the disposable canister has not been properly disposed of and has been recharged with another blood sample, thereby exposing the corresponding patient to infection. In such circumstances, the reading means would preferably be programmed such that the enabling mechanism allowing generation of ozone is not triggered. Thus, a blood oxygenating process having improved safety features is provided whereby an aliquot of blood is removed from the animal and placed in a disposable, labeled canister; the canister is then reversibly inserted into a receptacle in the oxygenating instrument for the administration of ozone, ultraviolet light, and heat to the contents of the canister; wherein the insertion of a properly labeled canister trips a triggering mechanism that enables the instrument to administer a predetermined amount of ozone, ultraviolet light and heat to the contents of the blood canister; and the aliquot of blood is then returned to the circulatory system of the animal. Preferably, the triggering mechanism is tripped by an identification system whereby the reading means in the instrument affirmatively acknowledges the identification means (label) on the canister.

The foregoing embodiments are merely exemplary. It is contemplated that other embodiments within the scope of the following claims will be apparent to those skilled in the art.

^S(WT E SHEET (RULE 26)

Claims

WHAT IS CLAIMED IS:

1. An apparatus for anti-viral autohaemotherapy comprising: a) a blood canister; b) an instrument that is an ozone, ultraviolet light, and heat source having a receptacle corresponding to the dimensions of the canister; wherein the instrument further comprises a triggering mechanism that enables the generation of ozone, ultraviolet light and heat when the canister is properly inserted into the receptacle.

2. An apparatus for anti-viral autohaemotherapy comprising: a) a disposable canister bearing external identification means; and b) an instrument that is an ozone, ultraviolet light and heat source further comprising means for reading said canister identification means when said canister is properly inserted into a receptacle in the instrument, and which, upon reading said identification means, enables the instrument to generate and administer said ozone, ultraviolet light and heat to the contents of the canister.

3. The apparatus of claim 2 wherein said canister and said receptacle have complementary configurations such that when the canister is inserted into the receptacle, the canister identification means aligns with the reading means to enable the instrument.

4. The apparatus of claim 2 wherein the identification means is a bar code identification means and said means for reading is a bar code reader.

5. The apparatus of claim 2 wherein the identification means is a magnetically coded identification means and said means for reading is a magnetic reader.

6. A disposable blood canister having external identification means and further comprising a gas inlet means and a temperature monitoring means.

7. The disposable canister of claim 6 wherein the identification means is a bar code identification means.

8. The disposable canister of claim 6 wherein the identification means is a magnetically coded identification means.

9. A process for improving the immune response of an animal comprising: a) removing an aliquot of blood from the animal and placing the aliquot in a disposable canister; b) reversibly inserting the canister into a receptacle in an instrument for administering ozone, ultraviolet light, and heat to the contents of the canister wherein the act of inserting the canister triggers an enabling means that causes the instrument to administer a predetermined amount of ozone, ultraviolet light and heat to the contents of the blood canister; and c) returning the aliquot of blood to the circulatory system of the animal.

10. The process of claim 9 wherein the enabling means comprises a bar code identification system.

11. The process of claim 9 wherein the enabling means comprises a magnetically coded identification system.

SUBSTITUTE SHEET {RULE 26)