Sterilization by low energy electron beam

Abstract

A sterilization apparatus wherein one or more electron beam tubes are used to direct electron beams into an ambient gaseous environment to create an electron plasma cloud into which non-sterile target objects may be moved. The electron plasma cloud is formed by interaction of the electron beam with the ambient atmosphere. Helium or other like gaseous may be used to expand the effective volume of the electron plasma cloud. Manipulators are used to move target objects in the electron plasma cloud, exposing non-sterile surfaces to the cloud and then joining the surfaces together where appropriate. The beam tube used to generate the electron beam has a thin low energy absorbing window which allows relatively low energy beams to be used, minimizing damage to materials within the surface of the target objects.

Description

TECHNICAL FIELD

The invention relates to beam sterilization of surfaces of objects and, more particularly, to sterilization which relies mainly on electron beam interaction with surfaces of objects.

BACKGROUND ART

In the fields of medicine, pharmaceutical production, and food processing there is a critical need for sterilization to protect against the danger of harmful microorganisms. Most of the sterilization methods currently in use require the sterilizing agent to systemically permeate the article being sterilized. These methods include heat sterilization, where the object to be sterilized is subjected to heat and pressure, such as in an autoclave. The heat and pressure penetrates though the object being sterilized and after a sufficient time will kill the harmful microorganisms. Gases such as hydrogen peroxide or ethylene oxide have also been used to sterilize objects. For the complete sterilization of an object, the gas must permeate the entire object. An alternate sterilization method uses ionizing radiation, such as gamma-rays, x-rays, or energetic electrons for sterilization.

There are a number of target objects where exposure of the object to ionizing radiation would cause some deleterious effect on the target object. Examples include objects which would melt or degrade under heat sterilization, products that would degrade or react with chemical sterilizing agents, and materials that would be harmfully altered by exposure to high energy radiation, particularly ionizing radiation. It has previously been recognized that by confining ionizing radiation to the surface of a target object, the deleterious effect will not occur. On the other hand, most ionizing radiation is created by powerful beam generators, such as accelerators, and so a beam of ionizing radiation is inherently penetrating.

In U.S. Pat. No. 4,801,427 A. Jacob teaches a process for dry sterilization of medical devices subjected to an electrical discharge in a gaseous atmosphere to produce an active plasma. In one embodiment, Jacob teaches placement of articles on a conveyor belt which carries articles into an atmospheric pressure corona discharge gap operated in ambient air. The plasma is formed by a discharge between the grounded conveyor belt, acting as a cathode, and multiple needle-like nozzles, acting as anodes, which disperse a gas to be ionized, which may be an oxidizing gas such as oxygen or a reducing gas such as hydrogen. U.S. Pat. No. 5,200,158, also to A. Jacob teaches sterilization by exposure of an object to a gas plasma created by an electrical discharge in a sub-atmospheric gaseous atmosphere. Hydrogen, oxygen, nitrogen, and inert gasses are all taught as possible gasses to use in forming the plasma.

In contradistinction to the high energy approach of Jacob, U.S. Pat. No. 3,780,308 to S. Nablo teaches surface sterilization of objects using low energy electrons, even though a relatively high energy starting point is present. One of the advantages of low energy electrons is that bulk properties essential to the mechanics of the material sterilized are not affected. Nablo expanded upon his idea in U.S. Pat. No. 4,652,763 which teaches use of an electron beam producing electrons with energies that penetrate an outer layer but with insufficient energy to pierce an inner layer of target material.

A number of patents teach use of a gas plasma to effect surface sterilization. Fraser et al., in U.S. Pat. No. 3,948,601 teaches use of a continuous flow gas plasma supplied at very low pressure in a chamber with a target object to be sterilized. Cool plasma from a gas such as argon is continuously produced by exposure to a radio-frequency field.

One of the problems encountered in prior art sterilization devices involves three dimensional structures, such as vials, cuvettes and hoses. Sometimes such structures have contours which create shadows for a beam of ionizing radiation nor even a diffuse discharge such that reactive electrons or ions do not reach the contours and so there is little sterilization in such regions. One solution would be to rotate or otherwise turn the object being sterilized.

An object of the invention was to devise a sterilization apparatus for medical equipment and the like, having three dimensional structure, with full sterilization of contoured regions, using ionizing radiation, but not deleteriously effecting the target substance. Another object of the invention was to devise a sterilization apparatus which is more efficient than sterilization apparatus of the prior art.

SUMMARY OF THE INVENTION

The above object has been achieved with a sterilization chamber featuring one or more electron beam tubes generating low energy electron beams, preferably under 100 kV keV, a helium flow velocity from nozzle 23 of a few liters per minute is appropriate.

With reference to FIG. 4, an end of beam tube 11 is seen having a plasma cloud 21 beyond window 13. The plasma cloud is formed by the interaction of electrons from beam 15 with molecules of air. The electrons collide with molecules of oxygen and nitrogen, ionizing some of them. The ionized molecules together with the electrons remaining in the beam serve as agents of sterilization. The mechanism of sterilization is not precisely known, but it is thought that the electrons and energetic ions break down proteinaceous material, involving molecules of complex shape and function. Proteinaceous material on the target substances have been found to be sufficiently damaged by the plasma cloud that the surface associated with such material is considered sterile. Optionally, the shape of the plasma cloud may be adjusted by a magnetic field generated by a coil 65 outside of beam tube 11. Another coil, inside of the beam tube 11 may adjust the size and shape of the beam before it leaves the beam tube. A magnetic coil, such as coil 65 may also be used to steer the emerging electron beam 15 in a manner such that the plasma cloud may be moved. In FIGS. 5 and 6, a nozzle 71, connected to a gas supply tank 70, may be seen injecting a stream of a light inert gas 73, preferably helium to create a skirt 77, leading to an expanded plasma cloud 75, compared to that of FIG. 4 where the light gas was not injected. Nozzle 71 emits gas in a pattern surrounding the beam 15, serving to confine the electron beam as well as expanding the distance of the plasma cloud from the window 13.

FIGS. 7 and 8 show a composite electron beam tube arrangement 81 having electron beam tubes 83, 85 and 87 arranged in a triangular pattern. These tubes can irradiate a larger two-dimensional zone, compared to a single tube, or can be used to create a larger three-dimensional plasma cloud than a single tube. By using a multiplicity of tubes and nozzles, shadow areas may be eliminated in objects having a complex shape. The three tubes need not be aligned in triangular pattern as shown in FIGS. 7 and 8, but may be at places most advantageous for eliminating non-sterile shadows in target objects having surfaces with complex shapes.

Although helium gas has been mentioned as the preferred gas for expanding a plasma cloud, other light gasses, with atomic numbers less than oxygen, would also work. In particular, it has been found that if argon is used, argon becomes excited and persists as in a metastable state for a brief period of time which allows sterilization to occur by a different mechanism than ionized atoms.

In FIG. 9, a detail of electron beam tube 11 shows an annular nozzle 71 surrounding the window end of beam tube 11. Electrons emerge through window 13, but gas from a supply tank 23, introduced into the annular nozzle, emerges through an annular slit 72 to provide gas sheath around the beam emerging through window 13. Window 13 is seen to be recessed with respect to the remainder of the face of the electron beam tube, indicating the thinness of the window. This aspect is more clearly seen in FIG. 10 where the output of the beam tube is seen to have a face 82 made of a single crystal semiconductor material, such as silicon. The limit on the thinness of the window is the need to avoid stress between the vacuum environment inside of tube 11 and the ambient environment outside. As previously mentioned, cathode 12 produces electrons which are focused by the structure 14 and the helical coil 16 to be directed toward the window 13. Although the electron beam can be made to sweep by the coil inside the tube, the most common configuration is to enlarge the beam size to occupy the full extend of the window. Material on either side of the window carries away any heat dissipated by beam passage through the window. Such beam tubes are commercially available from American International Technologies, Inc. of Torrance, Calif.

Claims

1. A sterilization apparatus comprising,

an electron beam tube having a window permitting emergence of an electron beam from said tube into an ambient gaseous environment while preserving a vacuum environment in the tube, the electron beam having a trajectory within a plasma cloud defining a reactive volume stimulated by interaction of the electron beam with the ambient environment, with a beam energy less than 100 kV keV at the target, and

a moveable member manipulating objects in a plurality of directions within the reactive volume wherein the manipulated objects are sterilized.

2. The apparatus of claim 1 further defined by a nozzle surrounding a window end of said beam tube and injecting a gas directed at the electron beam.

3. The apparatus of claim 1 wherein the member is a robotic member having a robot hand and a robot arm.

4. The apparatus of claim 1 wherein the member is a glove box hand capable of moving in any desired direction and capable of manipulating a variety of objects including different sized objects.

5. The apparatus of claim 1 wherein a plurality of beam tubes have electron beams forming a common reactive volume.

6. The apparatus of claim 5 wherein the beam tubes are sufficient in number and arrangement to avoid shadows on specific objects placed in the reactive volume.

7. The apparatus of claim 1 further defined by a housing containing the ambient environment.

8. The apparatus of claim 7 wherein the housing has ports for insertion of material to be sterilized.

9. The apparatus of claim 1 further comprising magnetic means for steering the electron beam between the window and the plasma cloud.

10. The apparatus of claim 1 further comprising magnetic means for shaping the electron beam between the window and the plasma cloud.

11. A sterilization apparatus comprising,

a chamber with ports allowing insertion of objects to be sterilized and having a gaseous environment therein,

a plurality of vacuum tubes fixed relative to the chamber, each emitting an electron beam along a path into the chamber through a window separating the gaseous environment of the chamber from the vacuum of the tube, the beam paths from the tubes within a common plasma cloud stimulated by the electron beams interacting with the gaseous environment within the chamber, defining a volume associated with the plasma cloud wherein the objects to be sterilized are exposed to the plasma cloud, and

at least one moveable member manipulating objects in a plurality of directions in the reactive volume wherein manipulated objects are sterilized.

12. The apparatus of claim 11 further defined by a nozzle surrounding a window end of each beam tube and injecting a gas directed at each electron beam from each tube.

13. The apparatus of claim 12 wherein the injected gas is helium.

14. The apparatus of claim 12 wherein the injected gas is argon.

15. The apparatus of claim 11 wherein the chamber is a glove box hand capable of moving in any desired direction and capable of manipulating a variety of objects including different sized objects.

16. The apparatus of claim 11 wherein the gaseous environment is an air environment.

17. The apparatus of claim 11 wherein the gaseous environment is at atmospheric pressure.

18. A sterilization apparatus comprising,

a single electron beam tube having a window permitting emergence of an electron beam from said tube into an ambient gaseous environment while preserving a vacuum environment in the tube, the electron beam having a trajectory within a plasma cloud defining a reactive volume stimulated by interaction of the electron beam with the ambient environment, with a beam of energy less than 100 kV keV at the target, and

a glove box hand and a robotic member having a robotic hand and a robotic arm, said glove box hand and robotic member manipulating objects, the glove box hand manipulating objects including objects that differ in variety, size and shape from the objects manipulated by said robotic hand, in a plurality of directions within the reactive volume wherein the manipulated objects are sterilized by said single electron beam tube.