U.S. patent application number 11/863446 was filed with the patent office on 2008-01-24 for endoscope immersion tray.
Invention is credited to Idemudia Ehigiato, Scott D. Godfrey, Josh Hagerman, Michael J. Simmons, Su-Syin S. Wu.
Application Number | 20080019890 11/863446 |
Document ID | / |
Family ID | 35062993 |
Filed Date | 2008-01-24 |
United States Patent
Application |
20080019890 |
Kind Code |
A1 |
Wu; Su-Syin S. ; et
al. |
January 24, 2008 |
ENDOSCOPE IMMERSION TRAY
Abstract
A system provides for high level disinfection or sterilization
of an endoscope having a first portion adapted for immersion and a
second portion not adapted for immersion. The system includes a
container having a first basin sized and adapted to receive the
first portion of the endoscope for immersion, a separate and
adjacent second basin sized and adapted to receive the second
portion of the endoscope, a wall between the first basing and the
second basin, and a trough in an upper portion of the wall between
the first basin and second basin through which a tube connecting
the first portion of the endoscope and the second portion of the
endoscope may extend.
Inventors: |
Wu; Su-Syin S.; (Irvine,
CA) ; Hagerman; Josh; (Corona Del Mar, CA) ;
Simmons; Michael J.; (Milford, MI) ; Ehigiato;
Idemudia; (Belleville, MI) ; Godfrey; Scott D.;
(Dearborn, MI) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
35062993 |
Appl. No.: |
11/863446 |
Filed: |
September 28, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10928959 |
Aug 27, 2004 |
7291308 |
|
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11863446 |
Sep 28, 2007 |
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Current U.S.
Class: |
422/292 |
Current CPC
Class: |
A61B 1/123 20130101;
A61B 90/70 20160201; A61B 2090/701 20160201; A61L 2202/24 20130101;
A61L 2/183 20130101; A61L 2202/122 20130101; A61L 2/186
20130101 |
Class at
Publication: |
422/292 |
International
Class: |
A61L 2/18 20060101
A61L002/18 |
Claims
1-10. (canceled)
11. A system for high level disinfection or sterilization of an
endoscope having a first portion adapted for immersion and a second
portion not adapted for immersion, the system comprising: a
container comprising: a first basin sized and adapted to receive
the first portion of the endoscope for immersion; a separate and
adjacent second basin sized and adapted to receive the second
portion of the endoscope; a wall between the first basin and the
second basin; and a trough in an upper portion of the wall between
the first basin and second basin through which a tube connecting
the first portion of the endoscope and the second portion of the
endoscope may extend.
12. A system according to claim 11 and further comprising a lid for
covering at least the first basin.
13. A system according to claim 11 wherein the lid covers both the
first and second basins.
14. A system according to claim 11 and further comprising a
conformable seal at the trough adapted to conform about the tube
and seal the first basin from the second basin.
15. A system according to claim 11 and further comprising a
plurality of upwardly extending protrusions whereby to elevate the
second portion of the endoscope above a lower surface of the second
basin and prevent immersion in any solution accidentally carried
over into the second basin.
16. A system according to claim 11 and further comprising a
drainage path between a lower surface of the second basin and the
first basin whereby to drain any fluid accidentally entering the
second basin to the first basin to keep the second basin
essentially free of fluid.
17. A system according to claim 11 wherein the materials of the
container are resistant to degradation by or absorption of the
disinfection or sterilization solution when it comprises an active
ingredient selected from the group of gluteraldehyde and
ortho-phthalaldehyde.
18. A system according to claim 11 and further comprising
instructions for use thereof, said instructions including
directions for immersing the first portion of the endoscope in a
disinfecting or sterilization solution in the first basin and
placing the second portion of the endoscope into the second basin
and not immersing the second portion of the endoscope.
19. A system according to claim 11 and further comprising an
elastomeric seal for sealing the lid, container and endoscope at
the trough.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to systems and methods for
high level disinfection or sterilization of endoscopes through
immersion into disinfecting or sterilization liquids and more
particularly to the immersion of endoscopes having liquid sensitive
portions.
[0002] After a thorough cleaning, high level disinfection or
sterilization of an endoscope employing a liquid disinfectant or
sterilant solution is frequently performed in a basin. The basin is
filled with the solution and the solution is tested to ensure it is
of sufficient concentration. The endoscope is immersed within the
solution and all of the endoscope channels are filled with the
solution. Typically, the basin is covered with a lid. The endoscope
then soaks within the solution for a time period sufficient to
achieve the desired level of disinfection or sterilization. After
the immersion, the endoscope is processed to remove the sterilant
and any rinsing liquids.
[0003] While many endoscopes are designed to be completely
immersed, some endoscopes, such as those having ultrasonic
scanners, have sensitive electronics which are not completely
sealed from moisture. These electronics would be damaged through
immersion and thus at least this portion of the endoscope is not
suitable for immersion within the disinfecting or sterilization
solution. Current immersion practice with such endoscopes involves
leaving that sensitive portion outside of the basin and immersing
the remainder of the endoscope. However, some of the disinfecting
or sterilization solution may leak out along the flexible tubes of
the endoscope to reach electronic portion and to reach surfaces
upon which it has been placed. Since this solution by its very
nature tends to be hazardous, such releases of solution from the
basin are to be discouraged.
SUMMARY OF THE INVENTION
[0004] A method, according to the present invention, provides high
level disinfection or sterilization of an endoscope having a first
portion adapted for immersion and a second portion not adapted for
immersion. The method includes the steps of: placing the first
portion of the endoscope into a first basin of a container; placing
the second portion of the endoscope into a separate second basin of
the container; immersing the first portion of the endoscope in a
disinfecting or sterilization solution in the first basin; and not
immersing the second portion of the endoscope.
[0005] Preferably, the method further includes the step of covering
at least the first basin, but more preferably both the first and
second basins, with a lid.
[0006] Preferably, the first basin is sealed from the second basin,
such as by interposing a conformable seal between the lid and the
container, with the seal conforming around the endoscope where it
passes between the first basin and the second basin.
[0007] Preferably, the method further includes the step of resting
that portion of the endoscope within the second basin upon upwardly
extending protrusions so as to elevate it above a lower surface of
the second basin and thereby prevent immersion in any solution
accidentally carried over into the second basin.
[0008] Preferably, a tube connecting the first portion of the
endoscope and second portion of the endoscope is passed through a
trough in a wall between the first basin and second basin.
[0009] Preferably, the method includes the step of draining any
fluid from the second basin to the first basin to keep the second
basin essentially free of fluid.
[0010] Suitable disinfection or sterilization solutions preferably
include one or more active ingredients selected from the group of
gluteraldehyde, ortho-phthalaldehyde, peracetic acid, hydrogen
peroxide, performic acid, chlorine or hydrochloride generating
solutions, and ozone containing or generating solutions, most
preferably from gluteraldehyde and ortho-phthalaldehyde.
[0011] A system, according to the present invention, provides for
high level disinfection or sterilization of an endoscope having a
first portion adapted for immersion and a second portion not
adapted for immersion. The system comprises a container having a
first basin sized and adapted to receive the first portion of the
endoscope for immersion, a separate and adjacent second basin sized
and adapted to receive the second portion of the endoscope, a wall
between the first basin and the second basin; and a trough in an
upper portion of the wall between the first basin and second basin
through which a tube connecting the first portion of the endoscope
and the second portion of the endoscope may extend.
[0012] Preferably, the system includes instructions for use which
thereof, said instructions including directions for immersing the
first portion of the endoscope in a disinfecting or sterilization
solution in the first basin and placing the second portion of the
endoscope into the second basin and not immersing the second
portion of the endoscope.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a container system according
to the present invention for high level disinfection or
sterilization of an endoscope having a non-immersible portion
thereof;
[0014] FIG. 2 is a perspective view of an endoscope for
disinfection or sterilization within the container system of FIG.
1;
[0015] FIG. 3 is a detail view of a portion of the container system
of FIG. 1; and
[0016] FIG. 4 is an alternative embodiment of a container system
according to the present invention for high level disinfection or
sterilization of an endoscope having a non-immersible portion
thereof.
DETAILED DESCRIPTION
[0017] FIG. 1 illustrates a container 10 according to the present
invention. It comprises a large first basin 12 for receiving an
endoscope (not shown in FIG. 1) for immersion and an adjacent
smaller second basin 14 for receiving non-submersible portions of
the endoscope. A lip 16 encircles an upper portion of the container
10 and provides a sealing surface against which a cover 18 may
seal. The large basin comprises a circular bottom wall 20 and a
side wall 22 extending upwardly therefrom. Of course other shapes
are possible. The smaller basin 14 comprises a bottom wall 24
having the shape of a truncated pyramid and side walls 26 extending
upwardly therefrom. A series of ribs 28 extend upwardly from the
bottom wall 24 and serve to elevate that portion of the endoscope
in the small basin 14 above the bottom wall 24 to prevent immersion
thereof in any carryover liquid which may travel into the small
basin 14.
[0018] FIG. 2 illustrates an endoscope 30 of a type which might be
processed in the container 10. It comprises a flexible insertion
portion 32 connected to a control head 34. It also comprises a
scanner unit 36 connected via a flexible tube 38 to the control
head 34. It is the scanner 36 which generally is not susceptible to
an immersion during the disinfection process. The endoscope 30
illustrated in FIG. 2 is but one example of an endoscope having a
portion not susceptible to immersion. Many other designs carry this
limitation.
[0019] FIG. 3 illustrates how the endoscope 30 sits within the
container 10, with the scanner 36 in the smaller basin 14 and the
insertion tube 32 and control head 34 in the large basin 12. The
flexible tube 38 between the scanner 36 and control head 34 passes
through a trough 40 between the side walls 22 of the large basin 12
and 26 of the small basin 14.
[0020] As shown in FIGS. 1 to 3, the arrangement of the container
10 with one basin 12 for the bulk of the endoscope 30 and a
separate basin 14 for liquid sensitive portions of the endoscope 30
allows efficient high level disinfection or sterilization of those
portions of the endoscope 30 susceptible to immersion while
simultaneously protecting those portions of the endoscope 30 not
susceptible to immersion and preventing carryover of disinfecting
solution out of the container 1O. The trough 40 substantially aids
in preventing solution from transferring into the smaller basin 14
and the ribs 28 protect the scanner section 36 even if solution
gets into the small basin 14. An elastomeric seal or seals 41 can
be provided at the trough 40 to seal the trough 40 and flexible
tube 38 to further limit fluid carryover from the large basin 12 to
the small basin 14. Adding an additional seal 43 on the lid 18 in
registry with the trough 40 enhances the sealing.
[0021] FIG. 4 illustrates an alternative embodiment of a container
42. In this embodiment, a large basin 44 holds the bulk of the
endoscope and a small basin 46 connected thereto holds the scanner
36 a wall 48 separates the large and small basins 44 and 46 and has
a trough 50 therethrough as in the previous embodiment. Upwardly
extending protrusions 52 elevate the scanner 36 in the small basin
46. Departing from the prior embodiment, drainage, as through
apertures 54 or deep troughs is allowed from the small basin 46 to
the large basin 44. Thus, any fluid which makes its way into the
small basin 46 will drain back into the large basin.
[0022] The container 10 is preferably formed of materials not
susceptible to long or short term degradation by the desired
disinfection/sterilization solution. Suitable materials include,
without limitation, polyethylene (either high density or low
density), polypropylene, polyvinyl chloride (PVC),
acrylonitrile-butadiene-styrene (ABS), polycarbonate (PC),
polyether imide (PEI), polysulfone (PS), polyether sulfone (PES),
polyphenyl sulfone (PPS), liquid crystal polymers (LCP), and
polytetrafluoroethylene (PTFE). Some materials can be more
desirable when designing the container 10 to be compatible with
multiple disinfection and sterilization solutions, particularly
polypropylene, PEI, PS, PC and PPS.
[0023] The material chosen to some degree determines the preferred
forming techniques as will be understood by those of skill in the
art. Preferred construction methods include injection molding,
thermoforming and transfer molding. Other primary polymer
processing methods, such as rotomolding and casting, may be
employed. Secondary polymer processing methods, such as machining,
drilling, cutting, melt bonding and gluing, can be use to complete
the construction and connect various portions of the tray or to
attach the seal or seals 41.
[0024] The following description of operation refers to FIGS. 1 to
3. However, operation with the embodiment of FIG. 4 is similar.
After a medical procedure the endoscope 30 is thoroughly cleaned
according to the manufacturers instructions and prepared for
immersion in the container 10. Typically the cleaning will involve
block and leak testing of the endoscope channels, a manual
cleaning, as with an enzymatic detergent, of the exterior as well
as a manual cleaning of any endoscope channels suitable to receive
a cleaning brush. Remaining channels are flushed with cleaning
detergent and the entire endoscope and channels are then
rinsed.
[0025] The endoscope 30 is then immersed in a suitable disinfecting
or sterilization solution such as gluteraldehyde (available from
Advanced Sterilization Products Division Ethicon Inc., Irvine,
Calif. under the trademark CIDEX.RTM.) or ortho-phthalaldehyde
(available from Advanced Sterilization Products Division Ethicon
Inc., Irvine, Calif. under the trademark CIDEX.RTM.-OPA). Other
possible disinfection or sterilization liquids includes without
limitation, peracetic acid, hydrogen peroxide, performic acid,
chlorine or hydrochloride generating chemical solutions, such as
hypochlorite, hypochlorous acid and chlorine dioxide, and ozone
containing or generating chemical solutions. Combinations of any of
these liquids can be used, either together or sequentially.
[0026] Typically the solution is tested with a test strip to ensure
that it is of the required potency. Then all of the endoscope 30
with the exception of the scanner section 36 is placed into the
large basin 12 in such a fashion as to maximize filling of the
lumens of the endoscope. The scanner portion 36 is placed into the
smaller basin 14 with the flexible tube 38 extending through the
trough 40. Additional solution is manually squirted into the
endoscope lumens (not shown) as for example via a syringe. The
scanner portion 36 is typically treated by wiping it with the
solution which does not effect the same level of disinfection as
immersion, yet suffices as this part of the endoscope 30 is not
inserted into a patient and in fact should not contact the
patient.
[0027] The lid 18 is placed onto the container 10 and the endoscope
30 remains immersed for a sufficient period of time to effect the
desired level of cleaning or disinfection. After that time has
passed the endoscope is removed from the container 10 and rinsed
with sterile water, the channels flushed with alcohol and purged
with air to ensure that they are dry. The endoscope 30 is now ready
for its next use.
[0028] While the invention has been particularly described in
connection with specific embodiments thereof, it is to be
understood that this is by way of illustration and not of
limitation, and that the scope of the appended claims should be
construed as broadly as the prior art will permit.
* * * * *