as) United States
`a2) Patent Application Publication 0) Pub. No.: US 2002/0146343 Al
`Oct. 10, 2002
`Jenkinset al.
`(43) Pub. Date:
`
`US 20020146343A1
`
`(54) METHOD AND APPARATUS FOR RAPIDLY
`STERILIZING SMALL OBJECTS
`
`(76)
`
`Inventors: Geoffrey H. Jenkins, Wellesley Hills,
`MA(US); Richard Eckhardt,
`Arlington, MA (US)
`
`Correspondence Address:
`WOLF GREENFIELD & SACKS, PC
`FEDERAL RESERVE PLAZA
`600 ATLANTIC AVENUE
`BOSTON, MA 02210-2211 (US)
`
`(21) Appl. No.:
`
`10/017,475
`
`(22)
`
`Filed:
`
`Dec. 14, 2001
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/255,555, filed on Dec.
`14, 2000.
`
`Publication Classification
`
`Ente C07 cacsccssssssssssensssssesnstsnssnsisevee A61L 2/00
`(SL)
`(52) US. Ch.
`ceeescssssssssnsssesnsssstnstvesnesnatnesvesse 422/24
`
`(57)
`
`ABSTRACT
`
`A device that sterilizes or disinfects an object includes a
`housing having an openingforat least partially receiving an
`object, at least one movable member, attached to the hous-
`ing,
`that moves between an open position and a closed
`position, an ultraviolet light source within the housing, and
`an actuator that prevents the light source from emitting UV
`radiation until an object is placed at least partially within the
`opening of the housing and the movable memberis in its
`closed position.
`
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`Patent Application Publication Oct. 10,2002 Sheet 3 of 11
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`US 2002/0146343 Al
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`Patent Application Publication
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`Oct. 10,2002 Sheet 10 of 11
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`

`US 2002/0146343 Al
`
`Oct. 10, 2002
`
`METHOD AND APPARATUS FOR RAPIDLY
`STERILIZING SMALL OBJECTS
`
`PRIORITY CLAIM
`
`[0001] This application claims the benefit, under 35
`US.C. §119(e), of the filing date of U.S. provisional appli-
`cation serial No. 60/255,555 entitled “Method and Appara-
`tus for Rapidly Sterilizing Small Objects,” filed Dec. 14,
`2000, which is incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates generally to the field
`of sterilization or disinfection systems and methods.
`
`BACKGROUND OF THE INVENTION
`
`[0003] A number of small objects used in everydaylife,
`particularly those used in medical and hygienic applications,
`can serve as a transport mechanism for disease-causing
`microorganisms. Objects that are handled or breathed-on by
`different people, or come in contact with surfaces contami-
`nated by other people or animals, can themselves become
`contaminated. If these objects then contact another person,
`they can transmit diseases. Even the hands and clothing of
`medical or healthcare personnel can serve to transmit dis-
`eases.
`
`[0004] This contamination problem is particularly acute
`with objects used in medical facilities or
`for hygienic
`applications, or the hands and clothing of workers in these
`facilities, as they have a much higher probability of con-
`tacting infected people or surfaces. Some medical devices
`are designed to be placed in contact with diseased patients.
`If they are not sterilized between use on different patients,
`they can serve as the vector to transmit the disease from one
`person to the next. Examples of this are thermometers,
`otoscopes, blood pressure meters, stethoscopes and other
`devices used by used by doctors, nurses, and other medical
`or healthcare personnel.
`
`[0005] Some of these devices, such as the thermometer
`and otoscope are well recognized as disease vectors, and are
`commonly used with disposable elements or covers to
`prevent transmittal of microorganisms. For other devices,
`such as the stethoscope, protective covers are more difficult
`to implement. Disposable stethoscopes are expensive and
`are compromised in quality. Manual sterilization with dis-
`infectant chemicals is sometimes done, but
`this is time
`consuming and not performed as often as is desirable. The
`hands and clothing of healthcare workers typically are
`sterilized by washing,butthis is often inconvenient and time
`consuming.
`
`[0006] U.S. Pat. No. 5,892,233, which issued to Richard T.
`Clement on Jan. 26, 1996, describes a portable stethoscope
`sterilizer which uses UV light. This device requires the
`stethoscopeto be held by the device during a lengthy period
`of sterilization and, therefore,
`the sterilizer to be carried
`along with the stethoscope. Thus, a separate device is needed
`for each stethoscope and the healthcare worker must carry
`the sterilizer as they work, which is inconvenient.
`
`[0007] As should be appreciated from the foregoing, there
`exists a need for improved systems and methodsofsteril-
`ization or disinfection.
`
`SUMMARYOF THE INVENTION
`
`[0008] One embodiment of the invention is directed to a
`sterilizer/disinfector for sterilizing or disinfecting an object.
`The sterilizer/disinfector includes a housing, a light source
`disposed within the housing,a light seal to block light output
`from the light source from exiting the housing, wherein the
`object formspart of the light seal, and an actuator, triggered
`by detection of completion of the light seal to a certain
`degree, to permit light to be output from the light source.
`
`to a
`[0009] Detection of completion of the light seal
`certain degree can be accomplished in a numberofdifferent
`ways. For example, a device can be used which detects
`mechanical positions of elements that form the seal. Alter-
`natively, an optical device can detect the degree of the light
`seal within the housing.
`
`[0010] Another embodimentof the inventionis directed to
`a methodofsterilizing or disinfecting an object comprising:
`introducing at
`least a first portion of the object
`into a
`sterilizer/disinfector; sealing light within the sterilizer/dis-
`infector using at least a second portion of the object to form
`a light seal; and automatically, upon detection of completion
`of the light seal to a certain degree, flash an ultraviolet light
`onto the at least a second portion of the object within the
`sterilizer/disinfector.
`
`{0011] Another embodimentof the inventionis directed to
`a device including: a housing having an openingfor receiv-
`ing an object; at least one movable member, attached to the
`housing,the at least one movable member movable between
`an open position and a closed position; an ultraviolet light
`source within the housing; and a detectorthat detects at least
`one of: (1) a degree oflight sealing of the housing caused at
`least
`in part by the movable member, (2) the movable
`memberbeing in the closed position, and (3) an object being
`located in a certain position at least partially within the
`housing; wherein, when the object is placed at least partially
`within the housing, the movable memberis in the closed
`position, and the detector detects the at least one of (1) a
`degree of light sealing of the housing causedat least in part
`by the movable member, (2) the movable memberbeing in
`the closed position, and (3) an object being located in a
`certain position at least partially within the housing, then the
`ultraviolet light source emits UV radiation to sterilize or
`disinfect the object.
`
`{0012] Another embodimentof the inventionis directed to
`a device comprising: a housing having an openingto receive
`at least partially an object; at least one movable member,
`attached to the housing, the at least one movable member
`movable between an opened position and a closed position;
`an ultraviolet light source within the housing; and an actua-
`tor that prevents the ultraviolet light source from emitting
`ultraviolet radiation until the object is placed at least par-
`tially within the housing and the movable memberis in its
`closed position.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0013] FIGS. 1-7 are diagrams illustrating a sterilizer/
`disinfector according to one embodimentof the invention;
`
`[0014] FIG. 8A and 9 are diagramsillustrating a light-
`tight seal according to one embodimentof the invention;
`
`[0015] FIG. 8B is a diagram illustrating a cross-sectional
`view along line A-A of FIG. 8A;
`
`13
`
`13
`
`

`

`US 2002/0146343 Al
`
`Oct. 10, 2002
`
`[0016] FIGS. 10A-C are diagramsillustrating vanes of a
`sterilizer/disinfector according to another embodiment of
`the invention;
`
`[0017] FIGS. 11-14 are diagramsillustrating a sterilizer/
`disinfector according to another embodiment of the inven-
`tion;
`
`[0018] FIGS. 15-17 are diagramsillustrating a sterilizer/
`disinfector according to a further embodimentof the inven-
`tion;
`
`[0019] FIGS. 18-20 are diagramsillustrating a sterilizer/
`disinfector according to another embodiment of the inven-
`tion;
`
`[0020] FIG. 21 is a block diagram of an electrical circuit
`for use in any of the described sterilizer/disinfector embodi-
`ments; and
`
`[0021] FIG. 22 is a diagram illustrating an electrical
`circuit for use in any of the described sterilizer/disinfector
`embodiments.
`
`DETAILED DESCRIPTION
`
`[0022] Overview of the Invention
`
`[0023] There is a need for a technique for rapidly steril-
`izing peoples’ hands and/or medical and hygienic devices,
`such as stethoscopes, particularly in the healthcare setting.
`The sterilization technique should be easy to use and very
`fast for greater user compliance. It should not use chemicals
`that need to be dried or removed, and it should not use heat,
`as some devices such as stethoscopes would be damaged by
`the high temperature neededforsterilization.
`
`[0024] One embodimentof this invention is directed to a
`rapid, easy-to-use, sterilizer/disinfector for hands, clothing,
`and hand-held or other small devices that uses intense
`ultraviolet (UV) light to kill microorganisms(e.g., bacteria,
`viruses, etc.). This sterilizer/disinfector can be used in a few
`seconds, does not require any chemicals that need to be
`replenished or removed from the device, and does not
`damage the object
`to be sterilized/disinfected with high
`temperature. In addition, this invention can heat the device
`to be sterilized/disinfected slightly (less than 20 degrees F.),
`which is usually considered an advantage for devices that
`come in direct contact with patients. This device can be
`powered from small batteries, and thus be completely por-
`table. The device can also be fixed-mountedto a wallor cart
`
`and/or powered from an AC line, as the entire sterilization
`procedure may require a sterilization time of a only few
`seconds (e.g., 1-3 seconds) or less than 1 second (e.g., 1
`millisecond or 100 microseconds).
`
`[0025] Sterilizer/disinfectors of this type can be made in a
`variety of configurations for specific purposes, or for gen-
`eral-purpose applications. For example, a special purpose
`device can be made expressly for sterilizing stethoscopes,
`and may be mounted to a wall or cart in a patient room or
`exam room. Thesterilizer/disinfector may be designed with
`a housing to enclose the UV light source and prevent
`damage to the eyes of people nearby. A single sterilizer/
`disinfector may be designed to accommodate several differ-
`ent devices. While the sterilizers/disinfectors of various
`embodiments described herein suggest possible sterilization/
`disinfection applications (e.g., stethoscopes, thermometers,
`drinking glasses), many other applications are possible in
`
`accordance with the invention. For example, the sterilizers/
`disinfectors described may be used for sterilizing/disinfect-
`ing pulse oximeters, toothbrushes, otoscopes, blood pressure
`meters, dental picks, and other devices used by doctors,
`nurses, dentists, hygienists, other medical and dental per-
`sonnel. Individuals may also use the sterilizers/disinfectors
`for a variety of medical, dental, and hygienic purposes.
`
` sterilized/disinfected may
`to be
`[0026] The devices
`include on their surface UV light-sensitive material that
`changes color after exposure to UV light to indicate suc-
`cessful sterilization. Materials of this type are available that
`will return to their original color after a few minutes for
`indication of the nextsterilization cycle. Further, patches of
`material that change color permanently after exposure to UV
`light may be included onthe surface of the device to indicate
`the total lifetime exposure to UV. The color of the patch may
`indicate whenit is time to replace the device.
`
`[0027] Sterilizer/Disinfector Operation
`
`Thesterilizer/disinfector can operate in one of two
`[0028]
`modes, or using any combination of the two modes. One
`mode involves disinfecting the surface of an object by
`flooding it with high intensity ultraviolet light. Light with a
`wavelength in the range of 160 to 300 nanometersis lethal
`to microorganisms. A total exposure of about 10 milliwatt-
`secondsofultraviolet light energy per square centimeter will
`typically sterilize/disinfect a surface. Greater or
`lesser
`amounts may be required depending on the exact charac-
`teristics of the surface and the environmental conditions,
`such as the temperature. The second mode involvesraising
`the surface temperature of an object to be sterilized/disin-
`fected to a temperature that is lethal to the microorganisms.
`Flooding the object’s surface with ultraviolet light will raise
`the temperature of the object. The increased temperature will
`also increase the effectiveness of the ultraviolet light steril-
`ization.
`
`[0029] Some embodiments of this invention can use both
`modesof sterilization/disinfection simultaneously by illu-
`minating the object to be sterilized/disinfected with a high
`intensity lamp, such as a xenon strobe light, that produces
`enough energy to heat
`the surface of the object
`to be
`sterilized/disinfected in addition to providing UV light.
`Xenon strobe lamps normally produce light across the
`spectrum of wavelengths between 160 and 2000 nanom-
`eters. For conventional applications of the xenon strobe,
`ultraviolet
`light having a wavelength of less than 380
`nanometers is not desired, so a glass envelope around the
`xenon gas is designed to filter the light
`in this range.
`However,
`for sterilizer/disinfector applications, a xenon
`lamp with an envelope of ultraviolet-transmitting glass, or
`other substance such as fused quartz, may be used to
`maximize the output of sterilizing/disinfecting ultraviolet
`light. The ultraviolet light and the light emitted in the visible
`and infrared range (380 to 2000 nanometers) will provide a
`significant amountof energy for instantaneous heating of the
`surface of the object to be sterilized/disinfected for more
`effective sterilization/disinfection in a short time. A short
`impulse of radiant energy will cause heating of the surface
`of the object so rapidly as to not heat the interior of the
`object. This requires far less energy than heating the entire
`object and will have less effect on the structural integrity of
`the object such as would be caused by the melting ofplastic.
`
`14
`
`14
`
`

`

`US 2002/0146343 Al
`
`Oct. 10, 2002
`
`downwardly and backwardly, in the direction of arrow 23.
`Tube 35, attached to the stethoscope head 3a, is guided into
`the top of front slot 5 by the user. Housing 2 is configured
`with slot 5 and vanes 15a,b to assist in guiding stethoscope
`head 3a and tube 3b into the correct location. If the UV
`illumination is distributed with sufficient intensity from all
`directions, the rotation of stethoscope head 3a isnotcritical,
`and it is not necessary to constrain rotation of head 3a asit
`is moved throughsterilizer/disinfector 1. This is an impor-
`tant feature to accommodate a variety of different configu-
`rations and sizes of stethoscopes.
`
`Human skin exposed to this light would experience only a
`slight warming feeling as the surface heat is quickly dissi-
`pated into the body.
`
`[0030] Using this flash lamp technique, small objects such
`as a stethoscope head could besterilized/disinfected with a
`total power to the xenon strobe lamp in the range of 20 to
`200 joules. This amount of energy is similar to that of
`standard cameraflash units. Flash lamps that are operated at
`a higher current density in xenon gas, asis the case in xenon
`short-arc lamps, produce a higher percentage of output light
`in the ultraviolet spectrum (a wavelength of 160 to 380
`nanometers) for more efficient operation in a sterilizer/
`disinfector application. Sterilization/disinfection may be
`accomplished with continuous or pulsed UV sources.
`Advantageously,
`less power per flash is required in UV
`sources that provide pulsed light rather than continuous
`light.
`
`sterilization/disinfection can be
`[0031] Alternatively,
`accomplished with other ultraviolet light sources that pro-
`vide a continuous or flashed (i.e., pulsed) ultraviolet light
`with wavelengths in the range of 160 to 380 nanometers.
`These light sources would provide continuous radiant heat-
`ing of the object, resulting in a smaller temperature gradient
`between the surface and interior of the object and a lower
`surface temperature. As a result of the lower surface tem-
`perature, the object benefits less from the heating.
`
`[0035] FIGS. 4 and 5 show the position of stethoscope 3
`at the time of the flash for sterilization/disinfection. To reach
`this position,
`the user guides stethoscope tube 3b down
`within slot 5 in the front of sterilizer/disinfector housing 2,
`in the direction of arrow 27 is (FIG. 5). Upon passing upper
`trap door 11 by stethoscope 3, door 11 moves in the direction
`of arrow 28to return to its resting position. Vanes 15a,b are
`initially in the position shown in FIG.2, against vane stops
`19a,b. As tube 3b contacts vanes 15a,b in the front of
`housing 2, the vanes are rotated about their pivot points
`17a,b. The vanes 15a and 15are rotated in the direction of
`arrows 25a and 25b, respectively, and are movedagainst one
`or more return springs (not shown). At the sterilization/
`disinfection position, shown in FIGS. 4 and 5, the vanes
`have rotated so that notches 16a, b (FIG.2) face one another,
`with the stethoscope tube 3b captured in the middle. A
`flexible seal (not shown) is built into the edges of notches
`[0032] One Embodiment of a Sterilizer/Disinfector that
`
`may be Used with a Stethoscope 16a,b to formalighttight-seal against tube 3b whenthe tube
`is positioned in slot 5, as shown in FIG.5. Front vanes 15a,b
`cover the front slot between upper trap door 11 and lower
`trap door 13 to form a complete light-tight housing when
`stethoscope 3 is in the sterilization/disinfection position.
`
`[0033] According to one aspect of the invention, a steril-
`izer/disinfector may be designed to sterilize and/or disinfect
`the head of a stethoscope, though the samesterilizer/disin-
`fector may also be used with other devices. Oneillustrative
`embodimentof a sterilizer/disinfector that may be used to
`sterilize/disinfect a stethoscope is shown in FIGS. 1-7. As
`illustrated in FIG.1, the sterilizer/disinfector 1 may use one
`or more xenon flash lamps 7 to create a flash of UV light
`(and/or visible and infrared light) of sufficient intensity to
`sterilize and/or disinfect a head 3a of a stethoscope 3 in less
`than 1 second (flash times of less than 1 millisecond are
`typical). One or more flash lamps 7 may be arranged in a
`housing 2, along with reflectors 9, to direct light produced by
`flash lamp 7, to intercept all surfaces of stethoscope 3 that
`are desired to be sterilized/disinfected, typically those of a
`head 3a at the end of a tube 3b of stethoscope 3. In the case
`of an electronic stethoscope,
`tube 3b may be a tubular
`structure including wires. Reflectors 9, light seal doors 11
`and 13, vanes 15a and 15, and other components that may
`be incorporated into sterilizer/disinfector 1, as well as a
`portion of the stethoscopeitself, prevent the majority of the
`light from reaching the user, which could be uncomfortable
`or possibly damaging. A portion of the stethoscopeitself also
`blocks light output from the sterilizer/disinfector, preventing
`a portion of light from reaching the user.
`
`In a preferred embodiment, housing 2 is designed
`[0034]
`in such a waythat head 3a of stethoscope 3 can be swiped
`in a smooth motion through a slot 5 in the front of housing
`2. FIGS. 1-7 show an example of how housing 2 can be
`constructed to contain the light flash while still allowing
`smooth motion through it. Housing 2 has a spring-loaded
`upper trap door 11, which pivots about a point 12, at the top
`end of housing 2. Whenstethoscope head 3a is movedin the
`direction of arrow 21 (FIG.3), upper trap door 11 is pushed
`
`15
`
`In accordance with one embodiment,thesteriliza-
`[0036]
`tion/disinfection flash is automatically triggered when
`stethoscope 3 reaches a particular position in slot 5. Since
`the total flash time may be less than 1 millisecond (and may
`be as short as 100 microseconds), it is not necessary to stop
`the continuous movementof stethoscope 3 for sterilization/
`disinfection. Even with very rapid hand pulling of stetho-
`scope 3 through slot 5, it may moveless than “ic inch during
`a 1 millisecondsterilization/disinfection flash duration.
`
`Theflash triggering mechanism canbe based either
`[0037]
`on the mechanical position of vanes 15a,b or on a light
`detector (not shown) or the like that determines when a
`sufficient degree of light sealing has been achieved. Some
`light may be emitted from the sterilizer/disinfector without
`exposing a user to dangerous UVlevels. For example, it has
`been shown that a gap in a light seal having dimensionsof
`Yo" by 1" does not result in dangerous exposure levels to a
`user at a distance of 1', even after hundreds or thousands of
`sterilization/disinfection cycles. Thus, a housing that
`is
`partially light-tight or substantially light-tight may be suit-
`able for applications of the sterilizers/disinfectors described
`herein. A dark interior of housing 2 may require that the
`light-tight seals are in place. If there is some possibility that
`the sterilizer/disinfector may be used in dark environment, a
`light (visible or infrared, etc.) could be included on the
`outside of housing 2. If this light is not detected from inside
`housing 2, it indicates that the seals are in place. If a proper
`seal is not formed, flash lamp 7 is not flashed, and an error
`indication is made to the user so that stethoscope 3 can be
`passed through sterilizer/disinfector 1 again.
`
`15
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`US 2002/0146343 Al
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`Oct. 10, 2002
`
`[0038] FIGS. 6 and 7 show the positions of sterilizer/
`disinfector 1 and stethoscope 3 after the sterilization/disin-
`fection flash. The motion of stethoscope 3 may continue
`smoothly downwardly in the direction of arrow 31 (FIG.7),
`without stopping at
`the sterilization/disinfection position
`(FIG. 4). As tube 3b is pulled though slot 5, front vanes
`15a,b continue rotating about their pivot points 17a, 17b
`against the force of their springs. Vane 15a moves clockwise
`about pivot point 17a in the direction of arrow 29a; vane 15b
`movescounter-clockwise about pivot point 175 in the direc-
`tion of arrow 29b. As vanes 15a,b rotate, stethoscope tube 3b
`is released from notches 16a,b in vanes 15a,b and continues
`movingthroughslot 5 in the direction of arrow 31. Head 3a
`of stethoscope 3 pushes lowertrap door 13, against the force
`of its return spring, such that lower trap door 13 rotates about
`pivot point 14 in the direction of arrow 31. The opening of
`lower trap door 13 allows stethoscope head 3a to exit
`sterilizer/disinfector 1 though the bottom of the unit. After
`head 3a and tube 3b of stethoscope 3 have moved clear of
`sterilizer/disinfector 1, springs (not shown) cause lower trap
`door 13 and vanes 15a,b return to their original rest posi-
`tions, as shown in FIG.1, ready for the next sterilization/
`disinfection.
`
`[0039] The embodiment of FIGS. 1-7 illustrates the ster-
`ilization/disinfection of a stethoscope head. However,
`it
`should be appreciated that the same sterilizer/disinfector
`could also be used with other objects that include a small
`neck of similar size to that of the stethoscope tube, such as
`a thermometer probe with the proper diameter handle, a
`pulse oximeter, or other medical, dental, or hygienic devices.
`Sterilizers/disinfectors using this same configuration may be
`made in different sizes to accommodate larger or smaller
`objects. The width of the slot and vane seals may be chosen
`to match the contour of desired objects, or the objects to be
`sterilized/disinfected can be designed to match a specific
`sterilizer/disinfector.
`
`[0040] For example, a sterilizer/disinfector using this con-
`figuration could be designed to sterilize and/or disinfect a
`person’s hand. Theslot and vane seals would be designed to
`seal against the wrist or forearm, and would accommodate
`a range in sizes. The open hand would be swiped through the
`sterilizer/disinfector in the same fashion as was described
`for the stethoscope, and a UVflash would sterilize and/or
`disinfect the surface of the hand. For this application, it may
`be desirable to block the long-wave UVlight (i.e., UVA and
`UVBin the range of 300 to 400 nm wavelength) to prevent
`sunburn or other skin damage resulting from repeated use.
`Sterilization/disinfection is accomplished primarily with
`UVC(i.e., wavelengths shorter than 300 nm) light. The skin
`is nearly opaque to UVC light. Current data appears to
`indicate that it is safe to use at levels that would sterilize
`and/or disinfect the skin surface.
`
`[0041] Objects to be sterilized/disinfected can also be
`specifically modified for use in a sterilizer/disinfector of this
`type, for example, by including a spot of UV-sensitive
`material on the surface of the object. UV-sensitive materials
`may employ photochromic inks or pigments which may be
`added to a material when molded(e.g., plastic) or added as
`a layer on a base material. UV-sensitive material may change
`color in response to UV light to indicate the total exposure
`to UV over a short period of time and then gradually return
`to the original color. This type of UV-sensitive material is
`typically used as a dosimeter to indicate sunburn potential
`
`when exposed to sunlight. A spot of this material on the
`device to be sterilized/disinfected can be used as an indicator
`of successful exposure to UV and,
`therefore, successful
`sterilization/disinfection. When the spot has returned to its
`original color, it can be used as an indicator for the next
`sterilization/disinfection. The formulation of the UV-sensi-
`tive material or the formulation of a filter layer over it may
`be chosen to provide the proper color change for the desired
`exposure level. Even if the wavelength sensitivity of this UV
`sensitive material is not the same as the wavelength range
`UV light needed for sterilization/disinfection, this type of
`indicator maystill be used, as the ratio of different wave-
`lengths of light
`from the sterilization/disinfection light
`source are known, and the sensitivity can be chosen accord-
`ingly to provide the proper indication.
`[0042] An indicator of lifetime UV-exposure can also be
`included on the device to be sterilized/disinfected. For
`example, a spot of material that exhibits a permanent color
`change when exposed to UV could be used as an indicator.
`This material may gradually change color over multiple
`exposures and may be visually compared to a reference
`color spot next to it. Matching colors may indicate that it is
`time to replace the device before significant degradation
`occurs. The formulation of the material or the formulation of
`
`a filter layer over it may be chosen to provide the proper
`color change over the total exposure desired. Even if the
`wavelength sensitivity of the UV-sensitive material is not the
`same as the wavelength range of UV light needed for
`sterilization/disinfection, the indicator can still work, as the
`ratio of different wavelengths of light from the sterilization/
`disinfection light source are known,and the sensitivity can
`be chosen accordingly to provide the proper indication.
`[0043] One Embodiment of a Light-Tight Seal for a Ster-
`ilizer/Disinfector
`
`[0044] FIGS. 8A and 9 show anillustrative embodiment
`of a compliant, light-tight seal 33 that may be used around
`a central hole 35 between vanes49in a sterilizer/disinfector
`configuration. The seals on each vane 49 may be made from
`a compliant elastomeric material and may be installed as
`mirror imagesin a recess 37 in the edge 43 of each vane 15.
`FIG. 8B illustrates a cross-sectional view along line A-A of
`FIG.8A, and showsan aspect of the invention in which seal
`33 may fit within a pocket 47 of vane 49. Seals 33 are
`designed to accommodate objects having a range of sizes
`and shapes, and each may have a small internal radius 39
`(FIG. 8A)
`to accommodate small stethoscope tubes or
`devices with a small neck. Convolution in the material near
`hole 35 is designed to allow the material to easily stretch
`around a larger diameter 51. Each seal must be in contact
`with over at least half of the circumference of a device 45.
`To maintain the seal in contact with device 45, tension is
`maintained in the elastomeric material on the outside of the
`convolution. This tension is controlled by the cantilever
`mounting of the top and bottom anchor points 41a,b of seal
`33. The flexure of the material as larger diameters are
`inserted creates the tension which bends the cantilever
`
`section toward the hole. The flex points of the cantilever
`sections are significantly above and below the edges of the
`hole, so the tension causes the cantilever section to press
`inward against the top and bottom ofthe tube to keep the seal
`in contact with the tube in these areas.
`
`[0045] The embodiment of FIGS. 8 and 9 is one example
`of a seal design, which is made from a solid elastomer and
`
`16
`
`16
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`US 2002/0146343 Al
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`Oct. 10, 2002
`
`achieves its high compliance from the shape of the material.
`Seals made with foamed elastomer material or from low
`durometer (highly flexible) materials may be made with
`simpler geometry, but at the expense of reduced durability
`and longevity of use. Simpler seals may also be used in
`applications where a small amount of light
`leakage is
`tolerable and/or the device to be sterilized/disinfected is of
`a standard size, or is designed to seal easily to a specific
`mechanical configuration.
`
`[0046] Alternate Embodiment of Vanes for a Sterilizer/
`Disinfector
`
`[0047] An alternative embodiment of a pass through ster-
`ilizer/disinfector for similar applications uses front vanes
`that are in the same plane, rather than overlapping. An
`example of this configuration is shown in FIGS. 10A-C.
`According to this embodiment, vanes 53 include a larger
`vane 53a and a smaller vane 53b. As shown in Figure 10B,
`since vane 53a covers nearly all of the slot, except for a
`small area 57 next to opening 55, the smaller vane 53b only
`needsto be large enoughto fill this small area. A compliant
`seal (not shown) maybe included on the end of smaller vane
`53b that meshes with the seal on larger vane 53a to create
`a complete light-tight seal. A mechanical coupling between
`the vanes 53 mayalso be included to keep the vanes moving
`together.
`
`[0048] Alternate Embodiment of a Sterilizer/Disinfector
`that may be Used with a Stethoscope
`
`[0049] FIGS. 11-14 show anillustrative embodiment of a
`pass-through sterilizer/disinfector that uses extensions on
`oneofthe