Title of Invention

AN ENDOSCOPE CLEANING DEVICE

Abstract A cleaning device for cleaning a medical instrument such as an endoscope, which includes a fabric, wipe, or sponge impregnated with a composition which comprises: an enzyme such as a protease, alcalase, cellulase, lipolase: a surfactant and a humectant present in an amount to ensure that sufficient water is absorbed to reduce any hazard which would arise from use of the enzyme in dry form while maintain activity of the enzyme during storage. The cleaning device is adapted to remove at least a portion of externally adherent soiling on a surgical instrument by mechanical wiping; and to redistribute any remaining external soiling such that it is distributed as a film of thinner and more uniform thickness than on the unwiped instrument. The invention also relates to packaging of the cleaning device, and methods of use thereof.
Full Text TECHNICAL HELD
This invention relates to cleaning devices; and methods, and more particularly to a
method and apparatus for cleaning the exterior of contaminated surgical instruments.
The device has been developed for use in cleaning the exterior of rigid or flexible
endoscopes and will be described primarily with reference to that use.
BACKGROUND ART
An endoscope is an elongate tubular installment that may be rigid or flexible and which
incorporates an optical or video system and light source. Typically, the endoscope is
configured so that one end can be inserted to some depth into a surgical incision or body
cavity via an incision or orifice whereby surfaces on or near the internally inserted end of
the endoscope may be viewed by an external observer. A commonly used endoscope is a
flexible endoscope called a colonoscope and is used for diagnostic procedures of the
human colon. The colon insertion portion of the instrument is approximately two meters
long and has one or more hollow channels, or lumens.
Because of the high cost of endoscopes and the need to avoid cross infection from one
patient to the next, each endoscope must be thoroughly cleaned and disinfected or
sterilised after each use. This procedure is time consuming and presents major
difficulties because the endoscope becomes significantly contaminated with biological
material from the patient for example mucus, faeces, blood, pieces of tissue and the like.

A typical cleaning procedure involves raising and scrubbing the endoscope exterior
under running water for some time to remove gross contaminants, subsequently soaking
the endoscope in a suitable cleaning bath for 2 to 10 minutes, rinsing the instrument,
drying the instrument and then disinfecting it. On some occasions the gross
contaminants on the outside of the instrument are inadequately removed by rinsing and
the subsequent cleaning bath prior to disinfection. This inadequate external cleaning
then compromises the disinfection or sterilisation step since it is impossible to
reproducibly disinfect or clean a dirty instrument.
Because the time required for cleaning and disinfection or sterilisation is often longer
than the duration of the procedure in which the endoscope is used, capital must be
expended on a plurality of instruments or else cleaning becomes the determining factor
as to the rate at which procedures can be performed. Moreover a considerable amount of
time and materials are consumed in cleaning the brushes and other apparatus used to
clean the endoscope including the lumens;. Recently attention has been paid to improved
methods of cleaning the interior of the lumen (see eg our co-pending application
PCT/AU99/00669), however that method is not applicable to the exterior surface.
Cleaning the exterior remains a critical, difficult and labour intensive task. Various
sophisticated chemical and biochemical products, for example enzyme/detergent
compositions, have been developed for use as pre-soaks to loosen contaminants from the
exterior surface and to facilitate their subsequent removal by scrubbing. The ultimate
efficacy of such treatments is heavily dependant on (a) how diligently rinsing and
scrubbing is performed; (b) how much debris is on the surface after the examination and
the nature of such debris; and (c) whether the soiled, instrument has been allowed to dry

prior to cleaning and, if so, the temperature at which this drying took place. Moreover,
the present Applicant has found that rinsing and scrubbing with brushes often serves
merely to rearrange deposits on the surface of the instrument rather than to remove them.
Furthermore, the use of brushes may create a contaminated aerosol which can endanger
health-care workers in the vicinity.
Any discussion of the prior art throughout the specification should in no way be
considered as an admission that such prior art is widely known or forms part of common
general knowledge in the field.
It is an object of the present invention to overcome or ameliorate at least one of the
deficiencies of the prior art, or to provide a useful or more convenient alternative.
It is an object of certain preferred embodiments of the invention to provide a device and
methods to improve the speed and/or efficiency of cleaning endoscopes and the like. It
is an object of certain highly preferred embodiments of the invention to provide an
inexpensive effective device which can be manufactured inexpensively and which can be
disposable after a single use.
DESCRIPTION OF THE INVENTION
According to a first aspect the invention provides a cleaning device for surgical
instruments including a fabric, wipe, or sponge impregnated with a composition
comprising an enzyme, a surfactant, and a humectant As herein used the term "sponge"
includes polymeric open and closed cell foam materials as well as natural sponge.

Preferred embodiments of the invention are adapted for use in cleaning the exterior
tubular surface of an endoscope or external surface of another surgical instrument.
Preferably the device is impregnated with a composition comprising a combination of
enzymes selected from proteases, alcalastes, cellulases lipolases and mixtures thereof.
The enzymes used in examples and formulations hereafter are commercially available
aqueous enzyme solutions or suspensions and not pure enzymatic protein.
Preferably, the total quantity of enzyme solution or suspension is present in an amount
of 5 to 25 %w/w of the composition, and. more preferably in an amount of 10 to 20
%w/w of the composition.
Preferably, the humectant is present in the composition in an amount of 1 to 10 %w/w of
the composition and more preferably in an amount of 4 to 7 %w/w of the composition.
Desirably the surfactant includes at least one non-ionic surfactant.
Preferably, the non-ionic surfactant is present in tne composition in an amount of 5 to 45
%w/w. It is also preferred that if an anionic surfactant is present in the composition it
will be in an amount of 5 to 15 %w/w. Preferably, the total surfactant in the composition
is in an amount of 15 to 45% w/w.

Desirably, the device is adapted to contact a substantial arc of the circumference of a
tubular portion of the instrument, and is a dapted to slide axially along the length of the
tubular portion so as to wipe the surface. Preferably the device engages an arc of up to
360 degrees of the external circumference of a tubular portion of the instrument and is
resiliently deformable in the radial direction. More preferably, the device is fabricated
from hydrophilic fibres.
Preferred embodiments of devices according to the invention remove most of the
externally adherent soiling by a mechanical wiping action, but more importantly the
device serves to redistribute any remaining external soiling so that the contamination
which is not removed is distributed as film of thin and uniform thickness. That film is
thereby adapted to achieve more efficient and speedy soil removal by enzyme digestion.
According to a second aspect the invention provides a device for use in cleaning the
exterior surface of a tubular endoscope requiring cleaning, said device including a pad of
hydrophilic fibres having a groove extending from one end of the pad to an opposite end
and adapted lesiliently to engage a portion of the endoscope exterior surface, the pad
being adapted alone or with a complementary pad to substantially encircle said portion
and being resiliently deformable so as to engage the surface of the encircled portion,
whereby to uniformly wipe said exterior surface as the device is slid longitudinally along
the endoscope tube.
Preferably the pad is formed of a needle felt and has two spaced apart parallel grooves
each of arcuate cross-section which may be folded into alignment on opposite sides of a

tubular axis to form a tubular tunnel resiliently engaging the endoscope exterior about its
circumference.
In preferred embodiments a cleaning device according to the second aspect is febricated
from a non woven fabric and is impregnated with a plurality of enzymes, a plurality of
surfactants and at least one humectant. In a highly preferred form of this embodiment
the non woven fabric is packed as a roll, or perforated roll, of "wipes" in a dispensing
canister permitting one or more wipes to be drawn from the dispenser and torn off for
use and then disposal.
According to a third aspect the invention provides a package containing a cleaning
device for surgical instruments, said cleaning device including a single use fabric or
sponge impregnated with an enzyme, a surfactant, and a humectant.
In preferred embodiments according to the third aspect, the package is moisture
permeable.
The present applicant has found that a non woven fabric impregnated with an enzyme
composition provides an efficient means for wiping clean the outside of an endoscope.
In initial experiments, the non woven was impregnated with a known enzyme/detergent
composition. Packing the impregnated product dry maintained the activity of the
enzymes during storage and transport of the product but carried an unacceptable risk of
releasing dry proteases into the atmosphere, an inhalation safety hazard, when the
package was opened. Accordingly, it was thought necessary to moisten the impregnating

enzyme/detergent composition. This in turn required that each moist impregnated fabric
be packaged within a water impermeable barrier to prevent the device from drying out.
However that added significantly to the cost. The inventor then discovered that if the
device was impregnated with a humectant, a moisture permeable package could be
employed and the humectant ensured that sufficient water was absorbed in the
composition to prevent dry proteases from becoming a hazard when the package was
opened or the product used. Surprisingly, the activity of the enzymes was maintained
during storage. The product can then be simply removed from its package, wet under a
tap, and then wrapped around the end of an endoscope. The device is then slid along the
length of the endoscope to remove soiling. The product can be manufactured and
packaged at sufficiently low cost to be considered disposable after a single use.
A further advantage of devices according to the invention is that enzymatic action
commences during the scrub phase, that is to say at an earlier stage in the cleaning
process than has been practiced in the past, and thereby prolonging the overall enzyme
treatment time and in turn increasing cleaning efficacy.
According to a fourth aspect the invention provides a method of cleaning the exterior
surface of a surgical instrument in need thereof, said method including the steps of:
(i) wiping the exterior surface, wherein a resilient pad or a wipe is pressed
against an exterior surface of the surgical instrument and slid longitudinally to
mechanically remove gross soiling and at the same time redistribute any residue
remaining to a substantially uniform thickness., while at the same time;
(ii) subjecting the surface to treatment with an enzyme and a surfactant.


BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic diagram showing a first embodiment of a device according to the
invention in plan view.
Figure 2 is a schematic diagram showing the embodiment of figure 1 in cross sectional
elevation.
Figure 3 is a schematic diagram showing the device of figures 1,2 in cross-sectional
elevation wrapped circumferentially around an endoscope tube.
BEST MODES FOR CARRYING OUT THE INVENTION
A preferred embodiment will now be described by way of example only with reference
to the drawings. The embodiment exemplified in figures 1 and 2 provides a cleaning
device in the form of a pad 1 made from a non woven needle felted polyester or viscose
fabric 2 bonded to a woven backing which can be made of polyester or polypropylene
fibres 3 on one surface. Pad 1 is of substantially rectangular shape having a width
dimension V of approximately 133 mm and a length dimension "1" of approximately 9
cm, and is approximately 15mm thick at its thickest dimension "t". The pad is heat
sealed around its perimeter and has two arcuate grooves 4, 5 of approximately
semicircular cross-section formed by heat moulding and extending in the length direction
centred at intervals of approximately one quarter "w" and three quarters "w" from one
edge 6. The grooves each have a radius of approx. 7mm. In addition there is a fold
groove 8 extending in the length direction on the midline, i.e. at a distance of hal "w"
from side edge 6.
9

In use, an endoscope tube is pressed into groove 4 bringing the pad into contact with a
semicircle of the endoscope cross-section. The pad is then folded over, as shown
schematically in fig 3, so that groove 5 contacts the remainder of the cross-section.
Figure 3 shows the pad of figures 1,2 folded along groove 8 so that grooves 4,5 are
brought into registration forming a cylindrical tunnel about an endoscope tube 9 which in
the present example has an outside diameter of approx. 14 mm. The polyester or viscose
needle felt structure has a degree of resilience, and the pad may be held around the
endoscope tube in a manner which compresses the pad exerting a resilient force acting
radially towards the tubular axis of the endoscope. The pad is thus pressed against the
exterior endoscope surface while the device is slid longitudinally to mechanically
remove gross soiling and at the same time the pad redistributes any residue evenly on the
surface, that is to say distributes it substantially uniformly in thickness about the
circumference and along the length. It will be understood that the dimensions of the pad
and grooves may be altered to suit different endoscopes, but an advantage of the design
is that the resilience of the pad accommodates a range of endoscope diameters.
An example of a suitable pad is composed of two different fibres, the first of which is
polyester or viscose of 3 denier and a fibre length of 51 mm and the second of which is
polypropylene of 2 denier and a fibre length of 51 mm. The ratio of the two fibres is
70% polyester or viscose and 30% polypropylene. These two fibres are mixed till
homogeneous and then tangled by the needling technique until a low density web with
substantially no free fly away fibres has been formed.


The thickness of the web is controlled by the amount of fibre and the needling equipment
employed, however a web of between 5 mm and 15 mm has proved to be ideal for the
application. The dry web is impregnated with a hygroscopic enzyme cleaning
formulation containing one or more enzymes, one or more surfactants, an enzyme
stabilising system and can contain a disinfectant compatible with the enzymes employed.
In a second embodiment not illustrated the pad is provided with a slit through which an
endoscope tube may be threaded and held in a clamped manner to similar effect
Although it is preferred to provide a pad with two grooves and to fold the pad, two
separate pads each with a groove could be similarly employed.
Devices may be manufactured with grooves of different dimensions to accommodate
instruments of differing diameter, althougfc. the resilience of the pad permits the device to
be used satisfactorily with instruments ovar a range of diameters.
In highly preferred embodiments, the pad is impregnated with a composition such as that
set out in example 1.
EXAMPLE 1
%w/w
Non-ionic surfactant (e.g. nonyl phenol ethoxylate) 10.0
Anionic surfactant (e.g. linear alcohol sulphonate) 10.0
Preservative (e.g. magnesium thionate) 0.15
Humectant (e.g. Calcium chloride hexahydrate) 4.5


Protease 10.0

Alcalase 3.5
Cellulase 1.0
Lipolase 1.0
Propylene Glycol 12.0
Tap water to 100
The activity units for the enzymes used in Example 1 are:
Protease 16 KNPU/gm or 5 AU/gm
Amylase 300 KNU/gm
Cellulase 1000 ECU/gm
Lipase 100 KLU/gm
Those skilled in the art will appreciate that enzymes are supplied on the basis of activity
units rather than protein concentration, and that the units used to define activity differ
depending upon the specific chemistry of the enzyme involved. However, those skilled
in the art will be familiar with reformulating enzymes of different activity and will be
readily able to adapt the formulations of the present invention according to the specific
circumstances.
EXAMPLE 2
Example 2 is identical to example 1 except that 4.5%w/ w glycerine is substituted for
Calcium chloride hexahydrate


The surfactants, preservatives and enzymes can be varied in composition and quantity in
accordance with formulation and compatibility requirements. Importantly, the
composition contains a humectant. Suitable humectants may for example be calcium
chloride, sodium chloride, glycerine, borax, ethylene glycol or such like. The humectant
may also be a surfactant.
One or more of the pads is packed together in a package which may be water permeable
This together with the presence of the humectant serves to keep the composition
sufficiently moist to avoid dry particles of enzyme from being released into the air when
the package is opened. Optionally, the formulation may contain a disinfectant
compatible with the enzymes, for example a quaternary ammonium compound.
The loading of composition on the fabric, wipe or sponge can be varied as desired. The
composition can be applied in any ratio, from a small amount, 1 to 5% of the weight of
the fabric, wipe or sponge right up to an amount which fully saturates the pad or wipe.
In use, a device according to the invention is removed from its package and may be.
further dampened with water, wrapped cireumferentially around an end of the endoscope
and wiped along the endoscope length to remove soiling. The pad is then disposed of in
a suitable manner. The enzymes commence digestive action immediately.
The endoscope, now free of most of the adherent soiling, is further cleaned in a suitable
cleaning solution and then disinfected or sterilized. Because any residue is now
distributed as a thin film of uniform thickness, subsequent treatment in a bath is effective


in a shorter time than would be the case if the exterior were merely scrubbed with a
brush.
Although the above discussed embodiment employs a viscose fibre pad, it is envisaged
that the pad could be made from a polymeric foam or suitable textile paper or hybrid
structure. However it is desirable that the device be not too absorbent since it is
desirable that the instrument remain moist.
A very highly preferred embodiment uses a roll of non-woven fabric "wipes'. The roll
is, for example, 8 meters long, and 10 cm wide and is perforated at 10 cm intervals, so
that up to 80 wipes of 10cmx 10 cm can be torn from a free end of the roll.
Alternatively, the product may be supplied in a canister containing 200 wipes in an 8
meter roll. The non woven fabric used in the wipes is a made from a cellulosic fibre (for
example viscose) web. This web is then treated with an aqueous dispersion of a flexible
cross-linking acrylic latex. The aqueous dispersion is such as to incorporate up to 15%
by weight and preferably about 8% by weight of dry acrylic polymer. Upon the addition
of a suitable proportion of a cross-linking catalyst; the non-woven structure is saturated
with the latex/catalyst dispersion and excess dispersion drained from the structure by
gravity, or else squeezed out with the assistance of compression rollers whereupon the
structure is then dried at a temperature appropriate to induce cross-linking. Upon
cooling a bonded, non-woven, open structured web has been achieved, and has the
following specification:
Basic mass (g./sq.m): about 42.5
Dry strength: (g/25 mm): 225


Thickness (um/4ply): 1270
Absorbency (g/5g): 420
The roll of wipes is contained in a dispensing canister which is preferably moulded from
plastic, has a diameter only slightly larger than the roll diameter and has a replaceable
closure which seals with the container. Under the replaceable closure is a canister lid or
wall provided with one or more slits disposed about the roll axis through which an end
of the roll can be dispensed. A formulation such as shown in example 1 or example 2,
and containing an enzyme and a humectant, is added to the container in sufficient
quantity to impregnate the non woven fabric. Thereafter, wipes may be pulled from the
canister and torn off the roll end as needed. In use, an impregnated wipe is held in the
gloved hand, moistened under a tap, and then used to wipe the exterior surface of an
instrument to be cleaned. By virtue of the slits the container is moisture permeable. An
additional outer removable closure may be provided to exclude particles and to inhibit
moisture loss. However the slits ensure that the moisture can permeate the package.
As will be apparent to those skilled in the art from the teaching hereof use of a device or
wipe according to the invention provide a major advance in convenience and efficacy
over existing methods for cleaning eadoscopes. The device or wipe maybe used for
cleaning other medical and non medical instruments, surfaces, and the like. The device
or wipe may be embodied in other forms or be manufactured from other materials
without departing from the inventive concept herein disclosed and the formulation may
be varied without departing from the invention.

1. A cleaning device for cleaning a medical instrument including: a fabric, wipe, or
sponge impregnated with a composition comprising at least one enzyme, a surfactant and
a humectant.
2. A cleaning device according to claim 1 including a disinfectant compatible
with said at least one enzyme.
3. A cleaning device according to claim 1 or 2 wherein the at least one enzyme is
selected from protease, alcalase, cellulase, lipolase, and combinations thereof.
4. A cleaning device according to claim 3 wherein the enzyme is present as a solution
or a suspension in an amount of 5 to 25 %w/w of the composition.
5. A cleaning device according to claim 4 wherein the enzyme is present as a solution
or a suspension in an amount of 10 to 20 %w/w of the composition.
6. A cleaning device according to any one of the preceding claims wherein the
humectant is selected from calcium chloride, sodium chloride, glycerine, borax, ethylene
glycol, propylene glycol and combinations thereof.
7. A cleaning device according to any one of the preceding claims comprising
glycerine as a humectant.
8. A cleaning device according to any one of the preceding claims wherein the
humectant is present in an amount to ensure that sufficient water is absorbed to reduce
any hazard which would arise from use of the enzyme in dry form.
9. A cleaning device according to any one of the preceding claims wherein the
humectant is present in an amount to maintain activity of the enzyme during storage.

10. A cleaning device according to claim 8 wherein the humectant is present in the
composition in an amount of 1 to 10 %w/w of the composition.
11. A cleaning device according to claim 9 wherein the humectant is present in the
composition in an amount of 4 to 7 %w/w of the composition.
12. A cleaning device according to any one of the preceding claims wherein the
surfactant includes at least one non-ionic surfactant.
13. A cleaning device according to claim 12 wherein the non-ionic surfactant is
present in the composition in an amount of 5 to 45 %w/w.
14. A cleaning device according any to one of the preceding claims wherein the
surfactant is a synthetic or natural alcohol ethoxylate.
15. A cleaning device according to any one of the preceding claims wherein the
surfactant includes at least one anionic surfactant.
16. A cleaning device according to claim 15 wherein the anionic surfactant is present
in the composition in an amount of 5 to 15 %w/w.
17. A cleaning device according to claim 15 or 16 wherein the anionic surfactant is a
hydrocarbon sulphonate or sulphate.
18. A cleaning device according to any one of claims 12 to 17 wherein the total
surfactant in the composition is in an amount of 15 to 45% w/w.
19. A cleaning device according to any one of the preceding claims including a
preservative.
20. A cleaning device according to any one of the preceding claims adapted to
i) remove at least a portion of externally adherent soiling on a surgical instrument by
mechanical wiping; and

ii) to redistribute any remaining external soiling such that it is distributed as a film of
thinner and more uniform thickness than on the unwiped instrument.
21. A cleaning device according to any one of the preceding claims adapted for use in
cleaning an exterior tubular surface of a surgical instrument.
22. A cleaning device according to any one of the preceding claims adapted for use in
cleaning an exterior tubular surface of an endoscope.
23. A cleaning device according to any one of the preceding claims adapted to contact
a substantial arc of an external circumference of a tubular portion of the instrument.
24. A cleaning device according to claim 16 adapted to engage an arc of about 360
degrees of an external circumference of a tubular portion of the instrument and which is
resiliently deformable in a radial direction.
25. A cleaning device according to any one of the preceding claims adapted to slide
axially along the length of a tubular portion of the instrument so as to wipe the surface
thereof.
26. A cleaning device according to any one of the preceding claims fabricated from
hydrophilic fibres.
27. A cleaning device according to any one of the preceding claims fabricated from
polymeric material.
28. A cleaning device according to any one of the preceding claims composed of
viscose fibres and polypropylene fibres.
29. A cleaning device according to claim 28 wherein the viscose fibres and
polypropylene fibres form a homogeneous mixture tangled by a needling technique to
form a low density web with substantially no free fly away fibres.


30 A cleaning device according to any one of the preceding claims in the form of a
wipe, or roll of wipes, fabricated from a polymeric foam, textile, paper or hybrid
material.
31. A cleaning device consisting in a fabric, wipe or sponge impregnated with a
hygroscopic enzyme cleaning fonnulatioa containing one or more enzymes, one or more
surfactants and an enzyme stabilising system.
32. A cleaning device according to any one of the preceding claims for use in cleaning
an exterior surface of a tubular portion of an endoscope in need of said cleaning, said
device including a pad having a groove extending from one end of the pad to an opposite
end and adapted resiliently to engage the exterior surface of the tubular portion of the
endoscope exterior surface, the pad being adapted alone or with a complementary pad to
substantially encircle the exterior surface of the tubular portion and being resiliently
deformable so as to engage the exterior surface of the encircled portion, whereby to
uniformly wipe said exterior surface as the device is slid longitudinally along the
endoscope tube.
33. A cleaning device according to claim 32 wherein the pad is formed of a needle felt
and has two spaced apart parallel grooves «jach of arcuate cross-section which maybe
folded into alignment on opposite sides of a tubular axis to form a tubular tunnel
resiliently engaging the exterior surface of a tubular portion of an endoscope about its
circumference.
34 A cleaning device according to claim 33 which may be folded about a longitudinal
fold seam.
19

35. A cleaning device according to any one of claims 1 to 27 fabricated from a non-
woven fabric and impregnated with one or more enzymes, one or more surfactants and at
least one humectant
36. A cleaning device according to claim 35 fabricated from a non-woven fabric
and impregnated with a plurality of enzymes, a plurality of surfactants and at least one
humectant
37. A package containing a cleaning device for cleaning a surgical instrument, said
cleaning device including at least one single use fabric, wipe or sponge impregnated
with an enzyme, a surfactant, and a humectant,
38. A package according to claim 37 wherein, the package is moisture permeable.
39. A method of cleaning the exterior surfce of asurgical instrument in need there of
with a cleaning device of any one or claims 1 to 36 said method including the steps of:
(i) wiping the exterior surface, wherein a resilient pad or a wipe is pressed against an
exterior surface of the surgical instrument and slid longitudinally to mechanically
remove gross soiling and at the same time redistribute any residue remaining to a
substantially uniform thickness, while at the same time
(ii) subjecting the surface to treatment with an enzyme and a surfactant.
40. A method according to claim 39 wherein a resilient pad or wipe is held around a
tubular portion of the surgical instrument in a manner which exerts a force acting
radially towards an axis of the tubular portion of tile surgical instrument.
41. A method according to claim 40 wherein the residue is redistributed to a more
uniform thickness about a circumference and a length of the tubular portion of the
surgical instrument.
42. A method according to any one of claims 39 to 41,- wherein the treatment of
step (ii) includes a humectant.


A cleaning device for cleaning surgical instruments substantially as herein
described with reference to any one of the drawings.
A cleaning device for cleaning surgical instruments substantially as herein
described with reference to any one of the examples.

A cleaning device for cleaning a medical instrument such as an endoscope, which
includes a fabric, wipe, or sponge impregnated with a composition which comprises: an
enzyme such as a protease, alcalase, cellulase, lipolase: a surfactant and a humectant
present in an amount to ensure that sufficient water is absorbed to reduce any hazard
which would arise from use of the enzyme in dry form while maintain activity of the
enzyme during storage. The cleaning device is adapted to remove at least a portion of
externally adherent soiling on a surgical instrument by mechanical wiping; and to
redistribute any remaining external soiling such that it is distributed as a film of thinner
and more uniform thickness than on the unwiped instrument. The invention also relates to
packaging of the cleaning device, and methods of use thereof.

Documents:

2184-KOLNP-2005-FORM-27.pdf

2184-kolnp-2005-granted-abstract.pdf

2184-kolnp-2005-granted-claims.pdf

2184-kolnp-2005-granted-correspondence.pdf

2184-kolnp-2005-granted-description (complete).pdf

2184-kolnp-2005-granted-drawings.pdf

2184-kolnp-2005-granted-examination report.pdf

2184-kolnp-2005-granted-form 1.pdf

2184-kolnp-2005-granted-form 18.pdf

2184-kolnp-2005-granted-form 2.pdf

2184-kolnp-2005-granted-form 3.pdf

2184-kolnp-2005-granted-form 5.pdf

2184-kolnp-2005-granted-pa.pdf

2184-kolnp-2005-granted-reply to examination report.pdf

2184-kolnp-2005-granted-specification.pdf


Patent Number 228777
Indian Patent Application Number 2184/KOLNP/2005
PG Journal Number 07/2009
Publication Date 13-Feb-2009
Grant Date 10-Feb-2009
Date of Filing 07-Nov-2005
Name of Patentee NOVAPHARM RESEARCH (AUSTRALIA) PTY LTD.
Applicant Address 3-11 PRIMROSE AVENUE, ROSEBERY, NEW SOUTH WALES
Inventors:
# Inventor's Name Inventor's Address
1 KRITZLER, STEVEN 9 REDGUM AVENUE, CRONULLA NEW SOUTH WALES 2230
PCT International Classification Number B08B 9/23
PCT International Application Number PCT/AU2004/000404
PCT International Filing date 2004-03-30
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 2003901917 2003-04-22 Australia