Patent Application
20060194706
The present invention relates generally to methods for cleaning dental and medical instruments. In particular, the invention is according to one aspect directed to a novel process of carrying out the cleaning of dental and surgical instruments to optimize both corrosion protection and cleaning efficiency.
According to another aspect, the present invention is directed to novel detergent-anti corrosion compositions for medical and surgical instruments which are particularly adapted for use in the cleaning process of the present invention.
Despite being fabricated from stainless steel, dental and medical instruments are subject to corrosion during the maintenance cycle (washing, disinfection, sterilization). Dental instruments are typically more susceptible to corrosion, owing to their higher carbon content. In order to achieve desired instrument characteristics such as surface hardness and durability, instrument manufacturers often resort to manufacturing processes such as heat treatment which also have the undesirable effect of compromising the resistance of the instruments to corrosion. In order to reduce the magnitude and rate of the process of corrosion, or even to prevent it from taking place altogether, some active corrosion protection steps have to be taken.
It has been known that in some cases, even just prolonged exposure to fresh water would start corrosion on the instrument surface. Some detergents developed for cleaning of medical instruments contain rust inhibitors. The action of these inhibitors is limited to the washing stage of the cleaning cycle, the only stage during which the detergent is used, conventionally. This typically excludes all rinsing stages and the final air-drying stage of the cleaning cycle. To cover these stages as well, different sets of chemicals are often used. These chemicals are known as rinse aids with rust inhibitors. A rinse aid serves the dual purpose of (i) changing rinse water properties in order to aid in the drying of the instruments, and (ii) improving protection against rust. Surgical milk products can also be used to protect the instruments' surface from corrosion after a rinse stage.
Such processes create the need for a number of different chemicals to be used during the wash cycle. The cost of individual chemicals, handling and chemical dispensing systems makes the cleaning process expensive and complex.
A typical cycle for cleaning medical instruments consists of a number of consecutive stages: pre-wash, wash, rinses (usually two) and drying. The pre-wash stage is used to dissolve blood on the instruments and it is run with cold water so as to prevent blood coagulation. The wash part of the cycle is run with hot/warm water and a detergent. Wash time, water temperature and detergent are matched according to requirements. A number of rinses are used to remove soil dissolved in the wash stage as well as the remaining detergent.
A number of detergents enhanced with rust inhibitors have been developed specifically for use in ultrasonic washers, where rinsing of the instruments is not recommended in order to maintain the presence of the detergent on the instruments' surface. An example is afforded by the Ultrasonic Solution made by Health Sonics Corporation. The rust inhibitors remain on the surface of the instruments after the cleaning cycle is finished. This rust protection has a time-limited action and will evaporate from the surface or get burned off during the usual high-temperature sterilization process, so that essentially no residuals are left on the surface of the instrument when it is next used on a patient.
Unfortunately, by avoiding the rinse stage in order to obtain the maximum protective effect of such rust inhibitors, the cleanliness of the instruments can be compromised. The very purpose of a rinse stage is to rinse away dirt loosened and dissolved in the wash stage, and to flush it out together with used detergent.
The term “no-rinse anti-corrosion detergent” will be used to refer to detergents enhanced with rust inhibitors that remain on the surface of instruments after the cleaning cycle is finished, where the rust protection has a time-limited action and will evaporate from the surface or get burned off during a high-temperature sterilization process, so that essentially no residuals will be present on the surface of the instrument when it is used on a patient.
We have found that a number of such no-rinse anti-corrosion detergents can, in fact, effectively be used in a washing cycle which includes wash, rinse and drying stages (as in a process-controlled spray washer) to protect against corrosion, but without compromising cleaning effectiveness. The detergent is used during the wash stage of the cleaning cycle to clean and prevent corrosion (as it is when used in an ultrasonic washer), but is also added, at lower concentrations, to subsequent rinsing stages, particularly the last rinse stage. This maintains a high level of corrosion protection without foregoing the rinsing which is essential for proper cleaning. This new method of cleaning instruments, in which at least the final rinse contains detergent, eliminates the need for multiple chemicals (cleaner, rinse aid, surgical milk).
We have also developed a family of specially formulated anti-corrosion detergent compositions containing a low foaming surfactant and alkyl pyrrolidones or certain alkyl amines, which afford corrosion control during washing/disinfection of medical instruments in automated washing systems having programmed wash and rinse stages.
As noted above, we have discovered that suitable detergents enhanced with rust inhibitors (chiefly, those for which the rust protection has a time-limited action and evaporates from the surface or is readily burned off during subsequent heat sterilization) can be utilized in a process-controlled spray washer, not only during the wash stage but in one or more rinse stages to optimize both cleaning and corrosion prevention. Such instrument washers are exemplified by the HYDRIM (trademark) instrument washers made by SciCan.
Table 1 illustrates a typical detergent dosing schedule for the pre-wash, wash and second rinse stages in the cleaning cycles of a HYDRIM C51W Instrument washer manufactured by SciCan. For this machine, the total water volume through the cleaning cycle is 3 L. The total volume of detergent dispensed in the prewash, wash and 2nd rinse stages are, respectively, 5.7 mL, 37 mL, and 11.37 mL.
Either of two cleaning programs (cycles) may be selected by the user. That designated P1 (normal) runs from pre-wash through a second rinse for about five minutes while the P2 (heavy) cycle takes about nine minutes. In each case, a low concentration (e.g. 30% of full strength) of an anti-corrosion detergent composition is added at the beginning of the pre-wash stage.
A higher level of the cleaning composition (full detergent concentration) is added at the beginning of the wash stage and again when the heating of the wash water has reached 45° C., to provide cleaning properties as well as corrosion protection. The temperature range over which the HYDRIM machine operates is from room temperature up to about 70 deg C. This detergent can also be used in washers/disinfectors which attain temperatures of 93 deg C.
A first rinse is run without any detergent. It is a short phase, the residual detergent from the wash phase still protecting the instruments.
The second (and any subsequent) rinse is run with a reduced concentration of detergent (e.g. 30% of full strength). Here the detergent is used for corrosion protection and as a rinsing aid. The detergent is changing the rinse water surface tension to increase water removal (shedding) from the surface. The chemicals from the detergent also protect instruments from corrosion while wet and during the drying cycle. The dry surface left behind is visually clean with no harmful residuals. Detected residuals are at a level below than 23×10−3 μg/mm2 of instrument surface, a result which is comparable to that obtained when any other rinse aid generally used. The residuals are invisible and do not adversely affect the instrument appearance, performance, useful life or maintenance cycle.
A number of commercially available no-rinse anti-corrosion detergents intended for use in ultrasonic cleaners may advantageously be used according to the method of the invention. That is, they may also be added at stages subsequent to the washing stage of a cleaning cycle. However, we have developed a specially formulated low foaming corrosion protection cleaning concentrate solution, containing a low-foaming surfactant and an alkyl pyrrolidone or alkylamine, which affords superior cleaning and corrosion inhibition properties.
It was found that cleaning concentrates according to the invention and diluted solutions, containing at least 0.005% of a low foaming surfactant and at least 0.005% of a C4-C16 alkyl pyrrolidone or C1-C18 alkylamine, exhibit surprisingly superior cleaning/corrosion inhibition properties, particularly in the cleaning of metal dental instruments. Certain such instruments often become rusted after cleaning and rinsing, but formulations according to the present invention prevent rusting and corrosion.
The cleaning concentrate solution of the invention has a neutral to alkaline pH, preferably from 7 to 12. Throughout this specification the concentrations of components in the aqueous cleaning compositions is stated in weight percent. The active components of low foam, corrosion protection cleaning solutions according to the invention are as follows:
The term “builder” is commonly used in the field of detergent formulation to refer to a molecule that can trap and remove multivalent cations like calcium and magnesium from the water. Such cations tend to precipitate the surfactant, forming undesirable scum or scale.
“Hydrotopes” are compounds used to increase the solubility of surfactants in aqueous solutions. Their use is described in textbooks and literature in this field, for example, The Book of Surfactants and Interfacial Phenomena by Milton Rosen.
Although a number of alkyl pyrrolidones have been used as surfactants, their effective role as corrosion inhibitors is novel and surprising. It is speculated that this may stem from the ability of C4-C16 alkyl pyrrolidones to become zwitterions in solution, with an ability to absorb to positively or negatively charged metallic surfaces, thereby providing an homogeneous protection against corrosion.
As for C1-C18 alkylamines, at neutral or slightly alkaline pH these compounds ionize to a quaternary ammonium form, that positive ion can adsorb to negatively-charged metal surfaces, again promoting the inhibition of corrosion.
Compositions according to the present invention may optionally contain as additional ingredients:
A set of washing tests was performed on stainless steel rods having high (min 0.15%) carbon content. This material had been heat treated to reduce corrosion resistance. The surfaces of these rods where inspected for the appearance of “rusting”.
While conventional no-rinse anti-corrosion detergents showed more than 25% of the surface covered with rust/corrosion, applicant's formulations of Table 2 all exhibited less than 5% corrosion coverage; the currently most preferred embodiment of the anti-corrosion detergent composition of the invention, set out in Table 3, produced no visually detectable rusting or corrosion on the surface of the test steel rods.
Notes:
1carrier
21-hydroxyethylidiene, 1,1 diphosphonic acid (builder)
3Potassium hydroxide (pH adjuster)
4solvent
5hydrotrope
6TM of BASF for polyoxyetheylene/polyoxypropylene co-polymer (defoamer)
7TM of Stepan for octyl sulfonate (anionic surfactant)
81,2,3 benzotriazole (anti corrosion agent for copper)
9corrosion inhibitor
10non-toxic pH buffer
11corrosion inhibitor
12TM of ISP for N-octyl-2-pyrrolidone (corrosion inhibitor)
13corrosion inhibitor and pH adjuster
14brand of Stepan for sodium xylene sulfonate (hydrotrope)
15TM of Ethox for ethyleneoxide/propyleneoxide co-polymer (non-ionic surfactant)
It will be understood by those skilled in the art that various modifications may be made in the methods and compositions described above without departing from the spirit and scope of the present invention. Accordingly, it is intended that the specific embodiments described herein be understood as illustrative only, and that the invention is limited only by the claims appended hereto.
This application replaces and claims priority from U.S. provisional patent application No. 60/652,701 filed on Feb. 15, 2005 and entitled METHODS FOR DENTAL AND MEDICAL INSTRUMENT CORROSION PREVENTION.
| Number | Date | Country | |
|---|---|---|---|
| 60652701 | Feb 2005 | US |
