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Patent 1156420 Summary

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(12) Patent: (11) CA 1156420
(21) Application Number: 1156420
(54) English Title: METHOD AND APPARATUS FOR STERILIZING AN OBJECT SUCH AS A CONTACT LENS
(54) French Title: METHODE ET DISPOSITIF DE STERILISATION D'ARTICLES, NOTAMMENT DES VERRES DE CONTACT
Status: Term Expired - Post Grant
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61L 02/00 (2006.01)
  • A61L 02/03 (2006.01)
  • A61L 12/02 (2006.01)
  • A61L 12/12 (2006.01)
(72) Inventors :
  • TANAKA, EISHUN (Japan)
  • HOTTA, KANBEE (Japan)
  • YANAGIHARA, YASUKICHI (Japan)
(73) Owners :
(71) Applicants :
(74) Agent: MARKS & CLERK
(74) Associate agent:
(45) Issued: 1983-11-08
(22) Filed Date: 1981-05-12
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
56-40115 (Japan) 1981-03-18

Abstracts

English Abstract


Abstract of the Disclosure
A method and apparatus for sterilizing an object such as
a contact lens wherein the object is immersed in a salt solution,
and a current is applied to the salt solution through two elec-
trodes to thereby produce in the solution a sodium hypochlorite
for sterilizing the object.


Claims

Note: Claims are shown in the official language in which they were submitted.


THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A method of sterilizing contact lenses comprising:
providing a container filled with a physiological salt
solution and having electrodes disposed therein for passing
a current in said physiological salt solution;
immersing said con-tact lenses in said physiological
salt solution contained in said container;
passing a current in said physiological salt solution
through said electrodes so as to produce a sodium hypochlorite
for sterilizing said contact lenses in said physiological
salt solution;
interrupting said current; and
allowing said contact lenses to remain immersed in said
physiological salt solution until said sodium hypochlorite
concentration is lowered to a level substantially innoxious to
the human eye tissue.
2. A method of sterilizing contact lenses comprising:
providing a container filled with a physiological salt
solution and having electrodes disposed therein for passing
a current in said physiological salt solution;
immersing said contact lenses in said physiological
salt solution contained in said container;
passing a current in said physiological salt solution
-22-

through said electrodes so as to produce a sodium hypochlorite
for sterilizing said contact lenses in said physiological salt
solution;
interrupting said current; and
reducing said sodium hypochlorite remained in said
physiological salt solution by using a reducing agent.
3. An invention as defined in claim 2 wherein said reducing
agent is added to said physiological salt solution before
applying said current thereto.
4. An invention as defined in claim 2 wherein said reducing
agent is added to said physiological salt solution after
interrupting said current applied thereto.
5. An invention as defined in claim 1,2 or 3 wherein said
contact lenses are hydrated contact lenses.
6. An apparatus for sterilizing contact lenses comprising,
a sealable container with a lid adapted to preserve said contact
lenses and having means for immersing and holding said contact
lenses in a physiological salt solution contained in said
sealable container, said sealable container having electrodes
disposed therein and adapted to pass a current in said physiological
salt solution; and a current supplying means for passing a current
through said electrodes so as to produce a sodium hypochlorite
in said physiological salt solution.
-23-

7. An invention as defined in claim 6 wherein said contact
lenses are hydrated contact lenses.
8. An invention as defined in claim 6 or 7 wherein said
current supplying means includes at least one of a timer means
for setting current-applying time and a constant-current means
for maintaining current at a constant level.
-24-

Description

Note: Descriptions are shown in the official language in which they were submitted.


1 ~ S~4~
METHOD AND APPARATUS FOR Sl'ERII.I~ING
AN OBJECT SUCH AS A CONTACT I,ENS
Background of the Invention
1. Field of the Invention
This invention relates to a method and apparatus for
sterilizing such objects as contact lenses, artificial teeth,
and scalpels and tweezers for medical use.
2. Description of the Prior Art
The conventional hydrated contact lens principally-comprising
hydrophilic monomer such as 2-hydroxyethyl methacrylate includes
normally about more than 30~ by weight of water. As a result,
the hydrated contact lens itself is likely to constitute a favor-
able circumstance for various detrimental bacteria to be multiplied.
Furthermore, it is very dangerous to wear the bacteria-infected
contact lens on the eyes without treating in any way, since this
practice may lead to a serious damage to the eye tissue. For this
reason, therefore, it is essential for such a hydrated contact lens
` to be sterilized at every given period of time.
For example, the prior art, in sterilizing the hydrated , :
contact lens, has employed a method of boiling the lens for
a predetermined time which is extremely effective for sterilizing
the lens but at the same time possesses not a few fatal disadvan-
tages, as hereinafter described.
- (1) The protein and other components in tear deposited on
the lens undergo a thermal metamorphism through boiling operation
.
-- 1 --

~ l~B4~
and stick to the lens surface, thereby irnpairing the optical
properties of the lens anc~ remarkably reducing the weariny
coziness on the eye.
(2) The sparingly cross-linked hydrophilic polymer, which is
the material of hydrated contact lenses~ is likely to be deterio-
rated through the repeated severe treatments of boiling. Thus,
the lens is subject to discoloration and/or change in standard
configuration, thereby resulting in reduced useful life of the
lens.
(3) The boiling disinfector is inconvenient to carry with
in trip because of the related boiling heater requiring an alter-
nating current, and especially, it cannot be used outdoors as
in a camping site where no alternating current is available.
~4) No boiling sterilization may be applied for non~hydrated
contact lenses which comprise polymethyl methacrylate and~or
silicone rubber.
In order-to alleviate the drawbacks associated with the
boiling sterilization, the prior art has also employed a method
of sterllization for-the contact lenses wherein the lenses are
-sterilized by disinfectant fluids containing thimerosal or chloro-
hexadiene for example. In such a treatment, the sterilizing
component will be readily be adsorbed into the lens body because
of the large structural distance between molecules constituting
the hydrated contact lenses. The adsorbed sterilizing component
has the potential hazard of causing hypersensitive inflammation
to the eye tissue.
The prior art has also proposed a method of detoxication
whereby the lens is sterilized with 3% aqueous solution of
-- 2 --

1 1 5~42~
hydrogen peroxide and the solution is catalized by platinum
or the like to decvmpose the hydroyen peroxide into water and
oxygen. This method has also disadvantayes that it requires
a considerably longer time in sterilization and is impractical
because of its complicated operation.
Sumrnary of the Inven-tion
An ob~ect of the present invention is to provide a method
and apparatus for sterilizing contact lenses which renders no
adverse influence to the material, standard and shape of the
lenses.
Another object of the present invention is to provide
a method and apparatus for sterilizing contact lenses, wherein
the sterilizing operation may be accomplished extremely in a
- short time and yet extremely simply with the lenses held in
protective containers.
A still further object of the present invention is to
provide a method and apparatus for sterilizing contact lenses
which is compact, lightweight, and easy to use; and yet may be
used outdoors where no external power source is available.
A still further object of the present invention is to
provide a method and apparatus wherein the sterilizing operation
for contact lenses is accomplished while producing the disinfectant
component, sodium hypochlori~e through electrolyzation of the
physiological salt solution which is a preserving liquid for the
lenses, to there~y eliminate the need for an extra souxce of
disinfectant liquid and allow for remarkable economy to users.

1 ~ ~ B4. 2 ~1
A still further object of the present invention is to
provide a method and apparatus for steriliziny contact lenses
wherein the lenses are free from harmful cornponent because of
spontaneous or operational dissolution of the sodium hypochlorite
into sodi.um chloride and oxygen which are safe to the eye tissue.
A still further object of the present invention is to
provide a method and apparatus for sterilizing contact lenses
wherein the sodium hypochlorite is also effective to rernove
protein in tear which is deposited on the lens surface.
A still further objéct of the present invention is to
provide a method and apparatus which may be adapted for steri-
lizing not only hydrated contact lenses but also such lenses as
non-hydrated contact lenses containing polymethyl methacrylate,
silicone rubber, etc., and artificial lenses to be grafted after
cataract operation; and medical instruments such as scalpels,
tweezers, injectors, artificial teeth and catheters.
Brief Description of the Drawings
.
~re~
Figure 1 is a front elevational view of a direct ~i~
supplying apparatus according to one embodiment of the present
invention;
Figure 2 is a p:Lan v.iew thereof;
- Figure 3 is a plan view of the appara-tus shown in Figure 1
with a cover removed;
Figure 4 is a sectional front elevational view of a container
for carrying a ccntact lens;
Figure 5 is a plan view of the container;

2 0
Fiyure 6 is a plan view of a tray for the contact lens;
Fiyure 7 is a schematic diag~am of the electrical cir-
cuit of the appara-tus; and
Figure ~ which is on the same sheet as ~igure 5 is a
schematic view illustratiny the operation thereof.
Deta~led Description of the Preerred Ernbodiments
The hydrated contact lenses are ir~nersed and preserved
in a 0.9~ physiological salt solution which is isotonic with the
tear fluid so as to confer affinity to the eye -tissue when the
lens is worn on the eye.
The present invention has positively utllized the above-
mentioned fact, and has found and invented that, with the contact
lens placed in the protec-tive container filled with physiological
salt solution, the lens may be sterilized thorugh electrolyzation
of the physiological salt solution in the container to produce an
available quantity of sodium hypochlorite.
More particularly, the contact lens is imrnersed in a pro-
tective container filled with physiological salt solution, and an
electric current is applied to the solution through an electrode
disposed in the container. Because of the current thus applied,
it is viewed that the chloride ions in the solution become chloric
molecules through anodic oxidation, and the chloride molecules re-
act with the sodium hydroxide formed in the solutiorl through bond-
ing of sodium lons and hydroxide ions, to thereby produce sodium
hypochlorite.
This series of reactions is expressed by the following
formula:

2 ~)
2 N~l ~ ~ 2 ~l2 t ~ 1 C~ t
C12 ~ 2NaO~ NaClO ~ NaCl t H2V
The sodium hypochlorite thus produced is effective for most
of microorganisms such as virus, ordinary aposporic bacteria,
acid-fast bacteria, bacterial spores, Hyphomycetes, Algae and
Protozoa, and it accomplishes the sterilizing action in an extremely
short time, about 30 to 180 seconds in a low concentration as of
a~out 0.5 to 5.0 ppm. Furthermore, the sodium hypochlorite is
feeble in its toxicity to the eye tissue althou~h it has strong
sterilizing characteristics, and from this point of view, it is
an extremely ideal sterilizing agent for contact lenses.
The concentra~ion of the sodium hypochlorite to be used for
contact lenses preferably ranges from about 0.4 to 4.0 ppm.
5O long as the concentration of the sodium hypochlorite is in the
above specified range, a sufficient sterilizing effect may be
expected, and after standing at the room temperature for about
six hours, the sodium-hypochlorite is spontaneously dissolved
into sodium chloride and oxygen to be thereby brought into a
concentration substantially innoxious to the eye. In consideration
of the act that contact lenses are sterilized generally before
the user goes to bed and are left to the room temperature as they
are in the container until the user put them on to his eyes next
morniny, it is reasonable and safe to the eye tissue to settle
the concentration of sodium hypochlorite within the range above-
mentioned.

4 2 V
It is also possible to decompose or reduce the sodium
hypochlorite to an innoxious state in extremely short time
by catalyz:ing -t:he steriliæed physiological salt solution with
platinum etc., or by adding reducing agent. For this particular
case, a higher concentration of sodium hypochlorite than specified
above may be employed.
Such reducing agents include, for exarnple, alkali or alkaline
earth metal salts of thiosulfuric ac.id such as sodium thiosulfate,
potassium thiosulfate and calcium thiosulfate; saccharides such as
d-glucose, ~-glucose, lactose, d-fructose, d-xylose and d-arabinose
cysteins such as cystein and methionine; organic or inorganic
peroxides such as sodium peroxide, barium peroxide, benzoyl
peroxide, peracetic acid and peroxy propionic acid; acid or its
alkali or alkaline earth metal salts such as sorbic acid, potassium
sorbate, citric acid and sodium citrate; good buffers such as
3-(N-morpholino) propane sulfonic acid, N,N-bis (2-hydroxyethyl)-
2-aminoethane sulfonic acid; sodium sulfite, sodium hydrogensulfite,
ascorbic acid, isoascorbic acid, glutathione, and disodium
ethylenediamine tetraacetate.
These reducing agents m.ay be added to the sterilized physio-
logical salt solution as discussed hereinbefore, but may be added
likewise to the physiological salt solution prior to steri~ization,
depending on the type of reducing agents to be used. More partic-
ularly, in case of the reducing agents such as saccharides,
cysteins, acid or its alkali or alkaline earth metal salts and
good buffers, the action of sodium hypochlorite (sterilizing
component~ is ger.erally more inactive to reducing agents than to
microorganism, and _herefore, the sterilized solution may be
-- 7 --

4 ~ V
reduced without impairing the sterili~ing ac~ion of sodium
h~pochlorite.
It should be noted that the decrease in salt concentration
of the physiological salt solution caused by the production o~
available sodium hypochlorite is extremely small, that is, on
the order of about 0.00001%, and thus no influence may be experi-
enced to the function as a preserving fluid for contact lenses.
It is also to be noted that, throughout the description of
this patent application, the use of the term "physiological
lU salt solution" refers to an aqueous solution of sodium chroride
which is isotonic with tear fluid and i5 physiologically innoxious,
and it should be understood in a broader sense which is capable
of including buffers and other components. Additionally, the
term "salt solution" should be interpreted as an aqueous solution
lS of not only soaium chloride but also potassium chloride, lithium
chloride, etc. which may produce a sterilizing sodium hypochlorite
through electrolyzation. The sterilizing action of potassium
hypochlorite and lithium-hypochlorite is well known, as with the
sodium hypochlorite.
Turning now more specifically to the drawings which disclose
an arrangement of one embodiment according to the present invention.
In the drawings, there is shown a pair of contact lens
protective container 2 integrally ~ormed with a connection portion
1 interposed therebetween, which are made of plastics such as
polyethelene,polypropylene, polycarbonate and polysulfone, or
of gla~s, which have a capacity of about 1 to 8 ml. The container
2 includes a cap 3 also made of plastics, the same material
as mentioned above, and removably sealingly attached to the
-- 8 --

1 1 ~6~20
container 2 through a groove 4 forrned on the outer periphery
thereof and a protrusion 5 formed on the inner periphery of the
cap 3. The containers 2 are filled with 0.9% physiological salt
solution 6 for preserving a contact lens 7 which in turn is
immersed therein on a lens tray 11 which is also made of the
same plastics as mentioned above. The curved surface of the
B tray 11 on which the lens 7 is placed has a -~E~ curvature
than that of the lens 7 and has a plurality of apertures 8 and
9 to permit fluidity of the solution 6 between i~side 10 and
outside of the tray 11. Additionally, on the bottom of each
container 2, there is embedded an electrode 13 with the top
surface thereof exposed to the inside of the container 2 and
with the bottom surface thereof brazed to a brass, conductive
plate 12 attached to the bottom surface of the container 2.
The material of the electrode 13 should be preferably
platinum or gold, etc. which has a ~ ionization tendency in
view of the fact that the anode is subject to a strong oxidi-
zation through the electrolyzation of the physiological salt
solution, but it may be replaced by a metal such as copper and
nickel or by plastics plated or vacuum-deposited with gold~or
platinum, etc. Additionally, the electrode 13 may be formed
integrally with the conductive plate 12, and gold or platinum,
etc. may be vacuum~deposited to the container 2 and the~ connecting
portion 1 so as to serve as the electrode 13 and the conductive
plate 12.
Reference numeral 14 represents the whole container unit
for carrying th~ contact lenses arranged as mentioned above and
adapted for connection with a direct current supplying unit 15

1 lt'j~42~
for delivering a current for electrolyzing the phy~iological
salt solu-tion 6 in -the container 2 through the elec-trode 13.
The direct current supplying unit 15 includes a case 16 ~1hich
in turn has a plastic body 17 and a plactic cover 19 secured
thereto with screws lB. On the upper surface of the cover 19,
there are provided a sliding power switch 22 effective for
turning on or off a battery 21 which i.s replaceably stored in
the case 16 through a socket 20; a push-button type starter
switch 23 to be used when the sterilizing operation for the
contact lens 7 is initiated: a LED (Light Emission Diode) 24
adapted to light for confirmetion of the on condition when
the power switch 22 is turned on; and a LED 25 adapted to light
by depressing the switch 23 for indication of the sterilizing
operation being performed during the electrolyzation of the
lS solution 6 in the container 2.
Furthermore, on the side face of the case 16 of the direct
current supplying unit 15, there is formed an inlet 26 having
a pair of guide grooves 27 provided on the:right and left sides
thereof for insertion of the portable container unit 14, which
in turn has a pair of projecting edges 28 formed on the right
and left sides of the container connecting portion 1. With the
edges 28 engaged into the grooves 27, the container unit 14 is
inserted into the case 16 from the inlet 26. Upon insertion of
the unit 14, the conductive plate 12 exposed at the ba;ttom of
the unit 14 abuts under pressure with a phosphor bronze, elastic
plate 30 secured to the case bottom by screws 29, and at the
same time, the electrode 13 of the unit 14 is connected to a
control device 31 secured inside the case 16 through the conductive
-- 10 --

2 ~3
plate 12 and the elastic plate 30.
Referring now to ~'igure 7 which illustratec3 an electrical
circuit of the ernbodimerlt according to the present i.n~ention,
a timer circui.t 32 ~or a monos-table multivibrator i~ connected
to the battery 21 through the power switch 22. In the circuit,
the monostable multivibrator is activated upon eneryization of
the starter switch 23 to generate a trigger signal, and is adapted
to energize each of transistors Trl and ~rr2 by inverting the
output from low to high ~or a given time determined by the resist-
ance value of the variable resistance VRl. A constant-c~rrent
circuit 33 is also connected to the battery 21, through the
transistor Tr2 and the power switch 22. The constant-current
circuit 33 comprises an operational amplifier Al, a zener diode
ZDl, a transistor Tr3, a resistance Rl and a variable resistance
VR2. The circuit 33 is then connected to the one of electrodes
13 of each container 2 through the transistor Tr3 and the variable
resistance VR2. Furthermore, the constant-current circuit 33 is
connected to a lower-limit-current setti.ng circuit 3~ which is
effective for deenergization of the LED 25 by inverting the output
of the operational amplifier A2 from low to high, when the voltage
drop due to the- current passing between the afore-mentioned one
electrode 13 and another electrode 13 connected to the transistor
Tr2 reaches below the specified voltage determi.ned by the variable
resistance VR3. Additionally, it should be noted that the circuits
32, 33 and 34 are suitably connected to resistances R2 through R9
and condensers Cl and C2 to form a circuit con~iguration.
The operaticn and basic arrangement of the embodiment will
be now described.

In Eigure 8, a contact lens 7 is immersed in the physio-
logical salt solution 6 in the protective container 2, ar.d an
electrical current is applied to the solution 6 from the battery
21 through the electrodes 13, variable resistance VR and power
switch 22 so as to electrolyze the solution 6. The potential
of the curren-t is determined by the resistance value of the
variable resistance VR, as already discussed above, and upon
electrolyzation of the solution, a sodium hypochlorite substan-
tially proportional to the potential is produced in the solution
6 to thereby e~fect sterilization of the contact lens 7. The
current is then interrupted through the power switch 22 to thereby
allow the sodium hypochlorite to be spontaneously dissolved into
sodiùm chloride and oxygen which are entirely innoxious to the
eye tissue.
More particularly, in order to accomplish a positive and
effective sterili~ing operation for the contact lens 7 by obtain-
ing substantially constant production of the sodium hypoch-lorit-e
during the operation, and to reduce the spontaneous dissolution
time after completion of the sterilization operation, the circuits
are arranged as follows:
(1) The cutput of the timer is set at 30 seconds for example,
through the variable resistance VRl;
(2) The ampere passing through the electrode 13 of each
container 2 is set at 1.3mA for example (2.6mA for both electrodes),
through the variable resistance VR2 of the constant-current
circuit 33;
(3) The lower-limit am2ere is set at 2.OmA for example,
through the variable resistance VR3 of the lower-limit current
- 12 -
.

setting circuit 34 adapted for ob-talning a lower-limit a~npere
at which the ou-tput current from the constant-cuxrent circuit 33
is sufficient enough to produce the sodium hypochlorite requirèd
for the effective sterillzing operation when the po~ential is
lowered due to the drain o the battery 21; and
~ 4) The operational amplifier A2 is set so as to invert its
output from low to high when the output current ~rom the constant-
current circuit 33 falls below 2.0mA of the lower limit.
With this arrangement and under the norrnal condition where
the battery is not drained, the contact lens tray 11 is placed
in both protecti~e containers 2, and a specified amount o~ 0.9
physiological salt solution 6 is poured into the containers 2.
A pair of hydrated contact lenses 7 removed from the user's eyes
are rinsed in the solution 6 and then immersed in the solution 6
while it is on the tray 11 in the container 2. The containers 2
are tight-closed with the caps 3 and the portable lens-container
unit 14 is inserted into the case 16 of the direct-current
supplying unit 15 from the inlet 26 thereof through the abutting
engagement of the.projecting edges 28 of the container unit 15
and the guide grooves 27 of the case 16. Upon insertion of the
container 14, the conductive plate 12 of the container 14 abuts
under pressure with the elastic plate 30 so as to allow the
electrodes 13 of the containers ~ to be connected to the output
terminal of the constant-current circuit 33. It is to be noted
that under the condition the sterilizing operation for the contact
lens 7 may be now initiated.
~ ccordingly, when the power switch 22 is turned on with the
above setting cQmpleted, the LED 24 will illuminate because of
- 13 -

4 2 ~
the low output prior to the activation o~ timer 32, 50 as to
confirm that the power i8 on. The starter switch 23 is then
depressed, and the output is inverted from low to high to thereby
~nergize each of the transistors Trl and Tr2. With this continuity,
a given current, in this instance, 1.3mA, is passed between the
electrodes 13 which is determined by the zener voltage of the
zener diode ZDl and the resistance value of the variable resist-
ance VR2. Because of this large voltage drop caused by the current
applied between the electrodes 13, the input voltage of the
operational amplifier A2 is higher at the inverted side, and
the output thereof is low-so as to cause the LED 25 to light and
confirm that an effective sterilizing operation is being performed.
After pre-set 30 seconds, the output of timer 32 will be inverted
from high to low to thereby deactivate each of the transistors
Trl and Tr-2. The output of the constant-current clrcuit 33
through the transistor Tr3 is turned off and the current passing
between electrodes 13 is then cut off so as to complete the
sterilizin~ operation for the contact lens 7. The LED 25 will
go out to confirm--the completion of the sterilizing operaticn,
and the power switch is turned off to ~omplete the whole steri-
lizing cycle. The lens container unit 14 is then allowed to
stand for at least 30 minutes, and the sodium hypochlorite of
the physiological salt solution ~ in the container 2 will be
decomposed into sodium chloride and oxygen which are innoxious
to the eye tissue. Thus, the lenses 7 sterilized in the container
2 are ready for immediate safe use.
Alternativ~ly, under the abnormal condition where the battery
is drained, the portable lens-container unit 14 is inserted into
' ' .
14 -

~ ~ S~42~
the case of the direct-current supplying unit 15, and the power
switch 22 and the s-tarter switch 23 are turned on. ~t this time,
if the output current o the constant-current circuit 33 falls
below 2.OmA which may not assure an effective sterilizing action,
the input voltage of the operational amplifier A2 is higher at
non-inverted side because of less voltàge drop between the elec-
trodes 13 and, because of the high output from the operational
amplifier A2, the LED 25 will not illuminate, thereby enabling
the operator to confirm that the sterilizing operation for the
~3 is ho I
contact lenses 7 arc being conducted effectively.
The present invention will be now further illustrated by
the following non-limitative examples:
\
Example I
In the contact lens protective container 2 (see Figure 8)
having a pair of platinum electrodes 13 of 0.04 cm2 surface area,
there was filled 2.2 ml. of 0.9~ physiological salt solution.
A 'hydrated contact lens 7 contaminated through actual use on the
eye was then immersed in the solution 6. (It should be noted
that if the immersed lens 7 directly overlies the electrode 13,
especially on the cathode, the production of chloric ions from
the cathode side will be hindered and the effective amount of
sodium hypoch'lorite may not be obtained.) The container 2 was
sealingly closed with a cap 3 and lightly shaken. Then', from'the
container 2 was taken 0.2 ml. of physiological salt solution;6,
into a sterilized test tube, which was used for a specimen to
determine the number of bacteria. Next, in the remaining 2.0 ml.
,
~ 15 -

1 2 ~
of the solution 6 and through the platinurn electrode 13 was
passed a current of 1.3mA for 30 seconds to thereby produce
sodilml hypochloxite of l ppm concentration in the solution 6.
Ten minutes later, each l.0 ml. out of the 2.0 ml. physio-
logical salt solution was inoculated in a thioglycolate medium
(15 ml.) for sterility test according to the Japanese Pharma-
copoeia, Method of General Test 34, in order to examine the
presence of bacteria.
The test was conducted to five subjects of contaminated,
hyarated contact lenses 7. The results of the test are set forth
in Table I.
Table I
. . ~
Lens No. Number of bacteria Results of sterility
before sterilization* test after sterilization
. _ _ . _ _ _
15 l 1.7 x 10 /ml. Negative
2 1.2 x 10 /ml. Negative
3 ~ 0.8 x lO /ml. Negative
4 2.9 x lO /ml. Negative
4.3 x lO /ml. Negative
* The number of bacteria before sterilization was obtained by
the following procedure:
(l) Each_0.1 ml. of physiological salt solution was prepared
from 0.2 ml. of unsterilized physiological salt solution
picked beforehand.
(2) The 0.1 ml. solution was then inoculated on a plane of an agar
culture medium and cultured at 37C for 24 hours.

1 ~S~4i~J
Example II
The following specimen strains were cultured on a slant of
an agar culture medium at 37C for 24 hours:
(1) Escherichia Coli 0 : 55 K : 59
(2) Staphylococcus aureus 209P
(3) Pseudomonas aeruginosa ATCC 9027
Each 103 cells/ml. of bacteria liquid was prepared with 0.9%
sterilized physiological salt solution 6. Then, each 2 ml. of
the liquid was poured into the same lens protective containers 2
as used in Example I. After the containers 2 were sealingly closed
with a cap, there was applied a 1.3mA of current through the
platinum electrodes 13 for 30 seconds to thereby produce 1 ppm
sodium hypochlorite.
Ten minutes later, each 1.0 ml. of test solution picked
from the above three specimens was inoculated in a thioglycolate
medium (15 ml.) for sterility test according to the above-mentioned
Japanese Pharmacopoeia, Method of General Test 34, in order to
examime the presence of bacteria. The results of the test are
set forth in Table II.
Table II
. .
; E. Coli S. aureus Ps. aeruginosa
Number of bacteria
before sterilization, 6,060 3,090 4,880
cells/ml.
Results of sterility
test after steriliza- Negative Negative Negative
tion
. _ . . _ ~
- 17 -

Example III
An aqueous solution oE 3.5 ml. was prepared hy mixing
the following acid and salts in the percent i.ndicated:
Trisodium citrate ... ~ ...... ...... 0.562%
Citric acid ................. ....... 0.006%
Sodium chloride .~........... ~...... 0.9%
The solution was filled in the contact lens protective
container 2 (see Figure 2) having a pair of platinum electrodes
13 of 0.12 cm surface area. A hydrated contact lens 7 contaminated
through actual use on the eye was then immersed in the solution 6,
as with Example I already discussed. Next, from the container 2
was taken 0.5 ml. of the solution 6 into a sterilized test tube,
which was used for a specimèn to deterrnine the number of bacteria.
Then, in the remaining 3.0 ml. of the solution 6 and through the
platinum electrodes 13 was passed a current of 6mA for 25 seconds
to thereby produce sodium hypochlorite of about .5 ppm concentration
in the solution.
Sixty minutes later, 2 ml. of test solution was picked from
3 ml~ of the solution and each 1.0 ml of the test solution was
inoculated in a thioglycolate medium tlS ml.) for sterilit~ test
according to the Japanese Pharmacopoeia, Method of General Test
34, in order to examine the presence of bacteria. On the other
hand, the remaining 1.0 ml. of the solution 6 was determined with
respect to the concentration of the residual sodium hypochlorite.
The test was conducted to five subjects of contaminated,
hydr.ated contact l~nses 7. The results of the test are set forth
in Table III.
- 18 -

Table IIX
__ __
Lens No. Nurnber of hacteria Test results Residual conc. of
(per ml.) before s. hypochlorite
sterilization
_ .
1 3.1 x 102Negative Less than 0.1 ppm
2 1.4 x 10Negative Less tha~ 0.1 ppm
3 2.5 x 10Negative - Less than 0.1 ppm
4 9.0 x 10Negative Less than 0.1 ppm
3.6 x 10Negative Less than 0.1 ppm
.: _
Examples IV and V
The sterilizing operations for contact lenses were conducted
in the same manner as that of Example III except the test conditions
were given as specified in Table IV. The test results are set
forth in Table V.
-- 19 --

1 ~&~V
o,~ o o
oa
~ rl
r l It') r-l
. '1~,
O '~
.. a~ _ u ~ 0
U r~ X '~ O ~rl
O _ ~ r~l 41 S l
r~ O~n U ~ ~ U
H ~ ~ ~ ~o: l~1 ~
1: H . '.
-- 20 --

Table V
. ~
Example Lens Number of bacteria Test results Residual conc. o~
No. (per ml.) before s. hypochlorite
sterili~ation
1 2.6 x 10 Negative O ppm
2 7.3 x 10 Negative O ppm
IV 3 4.8 x 10 Negative O ppm
4 1.1 x 10 Negative O ppm
1.3 x 10 Negative O ppm
. .
1 8.0 x 10 Negative Less than 0~1 ppm
2 3.9 x 10 Negative Less than 0.1 ppm
V 3 2.7 x 10 Negative Less than 0.1 ppm
4 6.2 x 10 Negative Less than 0.1 ppm
4.6 x 10 Negative Less than 0.1 ppm
. _ . _
-- 21 --

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Administrative Status

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Event History

Description Date
Inactive: IPC from MCD 2006-03-11
Inactive: IPC from MCD 2006-03-11
Inactive: IPC from MCD 2006-03-11
Inactive: Expired (old Act Patent) latest possible expiry date 2000-11-08
Grant by Issuance 1983-11-08

Abandonment History

There is no abandonment history.

Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
None
Past Owners on Record
EISHUN TANAKA
KANBEE HOTTA
YASUKICHI YANAGIHARA
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
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Abstract 1994-03-01 1 9
Claims 1994-03-01 3 70
Drawings 1994-03-01 4 63
Descriptions 1994-03-01 21 718