U.S. patent application number 10/499798 was filed with the patent office on 2005-03-24 for disinfection agent for suction systems used in the field of medicine.
Invention is credited to Biering, Holger, Decker, Michael, Von Rheinbaben, Friedrich.
Application Number | 20050065215 10/499798 |
Document ID | / |
Family ID | 7710786 |
Filed Date | 2005-03-24 |
United States Patent
Application |
20050065215 |
Kind Code |
A1 |
Biering, Holger ; et
al. |
March 24, 2005 |
Disinfection agent for suction systems used in the field of
medicine
Abstract
A thickened, ready-for-use disinfectant for medical or dental
suction apparatus, said disinfectant including a special active
substance of amine compounds with a viscosity between 100 and 2000
mPa.s, preferably between 350 and 1000 mPa.s.
Inventors: |
Biering, Holger;
(Grevenbroich, DE) ; Von Rheinbaben, Friedrich;
(Monheim, DE) ; Decker, Michael; (Solingen,
DE) |
Correspondence
Address: |
ECOLAB INC.
840 SIBLEY MEMORIAL HIGHWAY
MENDOTA HEIGHTS
MN
55118
US
|
Family ID: |
7710786 |
Appl. No.: |
10/499798 |
Filed: |
August 5, 2004 |
PCT Filed: |
December 13, 2002 |
PCT NO: |
PCT/EP02/14222 |
Current U.S.
Class: |
514/566 ;
514/673 |
Current CPC
Class: |
A61C 17/135 20190501;
A01N 33/04 20130101; A61L 2/18 20130101; A61L 2/16 20130101; A01N
33/04 20130101; A01N 33/04 20130101; A01N 33/12 20130101; A01N
33/04 20130101; A01N 2300/00 20130101 |
Class at
Publication: |
514/566 ;
514/673 |
International
Class: |
A61K 031/198; A61K
031/13 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 22, 2001 |
DE |
10163845.0 |
Claims
1-11. (Cancelled).
12. A thickened, ready-to-use disinfectant composition for a
medical or dental suction apparatus, the composition comprising an
active substance having the formula 4wherein R.sup.1 represents an
alkyl or alkenyl group with 8 to 18 carbon atoms and R.sup.2 is
selected from the group consisting of hydrogen, an alkyl group with
1 to 4 carbon atoms, an amino alkyl group with 2 to 4 carbon atoms,
and Glucoprotarmin.
13. The composition of claim 12, wherein the active substance is
selected from the group consisting of Glucoprotamin, N,
N-bis(3-aminopropyl)lauryl- amine, N-dodecyl-1,3-propanediamine,
N-coco-1,3-propanediamine, and mixtures thereof.
14. The composition of claim 12, wherein the active substance is
present from about 0.01 to about 30 wt. %.
15. The composition of claim 12, wherein the active substance is
present from about 0.01 to about 15 wt. %.
16. The composition of claim 12, further comprising a second active
substance comprising a quaternary ammonium compound having the
formula 5wherein R.sup.5 represents an alkyl group with 6 to 16
carbon atoms, R.sup.6 is selected from the group consisting of a
alkyl group with 1 to 12 carbon atoms, and a benzyl group, and
R.sup.7 and R.sup.8 are selected from the group consisting of an
alkyl group with 1 to 4 carbon atoms and a hydroxy alkyl group with
2 to 4 carbon atoms, and A.sup.- represents a charge compensating
anion.
17. The composition of claim 16, wherein the second active
substance is selected from the group consisting of benzalkonium
chloride and dimethyldioctylammonium chloride.
18. The composition of claim 16, wherein the second active
substance is present from about 0.01 to about 30 wt. %.
19. The composition of claim 16, wherein the second active
substance is present from about 0.1 to about 15 wt. %.
20. The composition of claim 12, wherein the composition has a pH
from about 8 to about 12.
21. The composition of claim 12, wherein the composition has a pH
from about 9 to about 11.
22. The composition of claim 12, further comprising a component
selected from the group consisting of tertiary amine oxide, anionic
surfactant, ether sulfates, alkylpolyglycosides, cationic
surfactants, non-ionic surfactants, amphosurfactants, silicone
defoamers, cumenesulfonate, xylenesulfonate, toluenesulfonate,
hydrophobically modified polymers, diluents, chelating agents,
enzymes, preservatives, sequestering agents, oxidizing agents,
bleaching agents, dyes, perfumes, and mixtures thereof.
23. The composition of claim 12, wherein the composition is
effective at destroying a microorganism selected from the group
consisting of a bacteria, a fungus, and mixtures thereof.
24. The composition of claim 12, wherein the composition is
effective at destroying mycobacteria.
25. The composition of claim 24, wherein the mycobacteria are
located in the suction tube of the medical or dental suction
apparatus.
26. The composition of claim 24, wherein the mycobacteria are
located in the spitting cup.
Description
[0001] The present invention is in the field of disinfection for
suction apparatus in the medical sector. It relates to
disinfectants for medical or dental suction apparatus and is also
directed to methods of maintaining such apparatus and to the use of
such disinfectants to destroy bacteria and/or fungi in such suction
apparatus.
[0002] Especially in the medical sector it is necessary to take all
reasonable measures to ensure safety of patients by preventing
possible transmission of pathogenic or optionally pathogenic germs
and avoid nuisance by odor-producing bacteria.
[0003] One possible center of growth of such germs is represented
by suction apparatus in the medical sector, which therefore require
regular cleaning and disinfection. For example, a mixed stream of
air, water, saliva, tooth substance and the like is sucked out of
the patient's mouth by means of dental suction apparatus, the air
is separated therefrom, and the rest is led to a drain. Components
of the mixed stream, in particular also bacteria, blood residues
and other contaminations deposit in the suction tubes and pipes.
Rinsing or other treatment with disinfectant-water mixtures at
regular intervals is intended to satisfy the requirements of
hygiene. For disinfection purposes, liquid disinfectant
concentrates based on quaternary ammonium compounds have normally
been employed up to now, which concentrates are diluted prior to
use. The disadvantage of this method is the insufficient residence
time of the disinfecting solution in the suction apparatus,
trickles forming due to flow-related circumstances, thereby
preventing uniform wetting of the inner surfaces of the tubes. In
addition, the quaternary ammonium compounds that are employed have
not more than a limited spectrum of activity against bacteria,
fungi and enveloped viruses. In particular, these active substances
fail to ensure effectiveness towards mycobacteria.
[0004] Another possible prior art use is the use of powdered or
granulated disinfectants according to DE 40 10 615. When used
following previous wetting of the suction system, a longer
residence time and sufficient, uniform wetting is possible in the
method according to DE 40 10 615. However, the disadvantage of this
method lies in ensuring a homogeneous distribution of the
disinfectant active substance in the product mixture employed,
which includes further solid formulation components such as
builders, cleaning components and other constituents. The demanded
homogeneity and stability of the powder mixture or granulate can
only be achieved by means of technically complex processes. Another
drawback is the limited selection of possible microbicidal agents,
because solid substances such as quaternary ammonium compounds or
salts of chloroisocyanuric acid or of tosylchloroamide are
preferably put to use. The disadvantages of using quaternary
ammonium compounds have already been described. On the other hand,
chlorine-containing active substances are AOX-forming substances
whose discharge into municipal sewage systems is restricted.
According to the invention, AOX-forming substances are understood
to be compounds which may result in the formation of organic
halogen compounds adsorbable on activated carbon.
[0005] Accordingly, it was the object of the present invention to
provide a disinfectant for suction apparatus, which would establish
uniform distribution of the active substances within the suction
apparatus and ensure sufficient residence time for the destruction
or inactivation of an extensive germ spectrum, especially of
mycobacteria and adenoviruses.
[0006] Consequently, the present invention is directed to a
thickened, ready-for-use disinfectant for medical or dental suction
apparatus, which includes an active substance selected from the
group of alkylpropylenediamines of general formula I 1
[0007] wherein R.sup.1 represents an alkyl or alkenyl group with 8
to 18 carbon atoms and R.sup.2 represents hydrogen, an alkyl group
with 1 to 4 carbon atoms or an aminoalkyl group with 2 to 4 carbon
atoms, and/or from the group of products known as
Glucoprotamin.RTM., as obtained from an alkylpropylenediamine of
formula II
R.sup.3--NH--CH.sub.2--CH.sub.2--CH.sub.2--NH.sub.2 (II)
[0008] wherein R.sup.3 represents a linear alkyl group with 12 to
14 carbon atoms, by reaction with compounds of formula III 2
[0009] wherein R.sup.4 represents hydrogen or an alkyl group with 1
to 4 carbon atoms, at a molar ratio of from 1:1 to 1:2 at 60 to
175.degree. C., characterized in that the ready-for-use agent has a
viscosity between 100 and 2000 mPa.s, preferably between 350 and
1000 mPa.s, measured with a Brookfield digital viscometer, model
LVTDV-II at a sample temperature of 20.degree. C. using a spindle
No. 2 (LV series, code number 62) at a spindle rotation of 12
revolutions/minute, the value being read after 60 seconds.
Ready-for-use means that the agent immediately introduced into the
suction apparatus has the above-mentioned properties.
[0010] The disinfectant according to the invention preferably
includes Glucoprotamin.RTM., N,N-bis(3-aminopropyl)laurylamine,
N-dodecyl-1,3-propanediamine, N-coco-1,3-propanediamine or a
mixture thereof as active substance mentioned above.
[0011] The disinfectant according to the invention preferably
includes from 0.01 to 30 wt.-%, particularly from 0.1 to 15 wt.-%,
relative to the overall agent, of one or more of the
above-mentioned active substances.
[0012] In another preferred embodiment the disinfectant of the
invention additionally includes a second active substance selected
from the group of quaternary ammonium compounds of formula I 3
[0013] wherein R.sup.5 represents an alkyl group with 6 to 16 C
atoms, R.sup.6 represents an alkyl group with 1 to 12 C atoms or a
benzyl group, R.sup.7 and R.sup.8 represent alkyl groups with 1 to
4 C atoms or hydroxyalkyl groups with 2 to 4 C atoms, and A.sup.-
represents an equivalent amount of a corresponding anion.
[0014] Particularly preferred active substances in accordance with
formula I are benzalkonium chloride and/or dimethyldioctylammonium
chloride.
[0015] Furthermore, the disinfectant according to the invention
preferably includes 0.01 to 30 wt.-%, especially 0.1 to 15 wt.-% of
said second active substance, relative to the overall agent.
[0016] The advantage of the present inventive disinfectant is that
following use, it forms a continuous layer on the inner surface of
the suction tubes or pipes, said layer substantially resisting
complete deliquescence during a specific period of time which
depends on the viscosity of the disinfectant. Therefore, a
disinfectant present in liquid form is not a composition in the
meaning of the present invention because such a solution
deliquesces almost instantaneously upon introduction into the
suction apparatus.
[0017] Another precondition is that the disinfectant of the
invention can be washed off after application and working in.
[0018] In principle, any gel comprised of a dispersed phase and
dispersant can be used as base of the formulation, provided the
components would not undergo undesirable reaction with the active
components of the invention. In a preferred fashion gels based on
water are used, especially water-based gels with dispersed organic
gel-forming agents. For example, gels as described in the
unexamined German application DE-OS 38 36 138 can be used.
Hydrophilic organic gels based on modified fatty alcohol
alkoxylates and polymers produced by synthesis, preferably gels
based on polyvinyl alcohol or polyacrylic acid derivatives are
particularly preferred.
[0019] Preferred commercially available thickeners are the raw
materials Optiflo.RTM. H 600/E from SD-CHEMIE and PLURIOL A 5000 T
85 from BASF. Optiflo H 600/E is a non-ionic, hydrophobic-modified
polymer, and PLURIOL A 5000 T 85 is a modified fatty alcohol
ethoxylate.
[0020] However, other thickeners such as carboxymethylcellulose,
non-ionically and cationically modified polyacrylate are also
possible.
[0021] In addition, the formulation may include conventional
additives such as coloring components, odorous substances, etc.
[0022] To produce the disinfectants of the invention, the
components are mixed together. Thus, the solvent, preferably water,
the active components, as well as thickeners, thixotropic agents,
gel-forming agents or film-forming agents, optionally surfactants,
especially low-foam surfactants, and other auxiliary agents such as
defoamers, corrosion inhibitors and complexing agents can be mixed
together.
[0023] The disinfectant, which is ready-for-use according to the
invention, preferably has a pH value of from 8 to 12, more
preferably from 9 to 11.
[0024] Furthermore, the disinfectant of the invention preferably
includes one or more additional components other than those
mentioned above and selected from the group of tertiary amine
oxides, anionic surfactants, ether sulfates, alkylpolyglycosides,
cationic surfactants, non-ionic surfactants, amphosurfactants,
silicone defoamers, cumenesulfonate, xylenesulfonate,
toluenesulfonate, hydrophobically modified polymers, diluents,
chelating agents, enzymes, preservatives, sequestering agents,
oxidizing (bleaching) agents, dyes and/or perfumes.
[0025] In particular, low-foam non-ionic surfactants such as fatty
alcohol alkoxylates with an alkyl group having 8 to 22 C atoms, end
group-capped or not, or well-known thickener amine oxides are
predominantly used as surfactants. When using anionic surfactants,
the amounts employed will be low due to their foaming behavior and
their compatibility with cationic active agents and/or
glucoprotamin, so that the use thereof would not give rise to
complaints.
[0026] The present invention is also directed to a method for the
maintenance of a medical or dental suction apparatus, particularly
the suction tube thereof, in which method an inventive disinfectant
is introduced into the suction area.
[0027] Furthermore, the present invention is directed to the use of
an inventive disinfectant to destroy bacteria, especially
mycobacteria and/or fungi, in medical or dental suction apparatus,
particularly in the suction tube thereof and in the spitting
cup.
[0028] The following examples are intended to illustrate the
invention in more detail, without limiting the scope thereof.
EXAMPLES
Example 1
[0029] Production of a disinfectant gel according to the
invention
[0030] a) 18 g of carboxymethylcellulose were sprinkled into 950 g
of water, added with 1.0 g of a 50 wt.-% potassium hydroxide
solution and mixed with stirring.
[0031] b) After completion of the carboxymethylcellulose swelling
process (2-5 hours), the solution produced under a) was added with
8 g of a 50 wt.-% Glucoprotamin.RTM. solution, 5 g of a 70 wt.-%
solution of dioctyldimethylammonium chloride in a water/isopropanol
mixture at a ratio of 2:3 and 5 g of a C.sub.12-18 fatty
alcohol-EO-BuO adduct with 8 EO and 8 BuO and mixed intensely.
Example 2
[0032] Use of the gel produced in Example 1
[0033] Stainless steel germ carriers according to DIN 10510 were
contaminated with Enterococcus faecium test organism in bouillon
with an additional organic load of 1% mucin and 20% blood and left
to dry for 2 hours at room temperature. The germ carriers were
fixed in the spray mist tube of a dental suction apparatus, with
one germ carrier at each of the front and far ends of the tube. For
disinfection, the tube was wetted by suction of 200 ml of water;
thereafter, 15 ml of a gel in accordance with Example 1, another
100 ml of water, and another 15 ml of gel according to Example 1
were sucked in.
[0034] Following a 60-minute exposure period, the gel was rinsed
off by suction of 500 ml of water.
[0035] Subsequently, the germ carriers were removed from the tube,
transferred into 10 ml of bouillon by shaking, and the colony
number of this bouillon was determined by plating on agar
plates.
[0036] In suitable comparative tests the gel according to the
invention was replaced by
[0037] a) an aqueous solution having the same concentration of
identical antimicrobial agents, but
[0038] b) lacking the properties of thickening consistency in equal
amounts, relative to the concentration of the antimicrobial
agents.
[0039] The differences of the logarithms (basis 10) of the colony
numbers found were determined as result (logarithmic reduction
factor, logRf). The results are summarized in the following
Table:
1 Disinfection medium logRf Gel according to Example 1 >5.2
Aqueous solution according to Example 3.4 1 with no
carboxymethylcellulose Water 2.5
* * * * *