US20050263421A1 - Cassette with encoded lumen claim - Google Patents
Cassette with encoded lumen claim Download PDFInfo
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- US20050263421A1 US20050263421A1 US10/856,435 US85643504A US2005263421A1 US 20050263421 A1 US20050263421 A1 US 20050263421A1 US 85643504 A US85643504 A US 85643504A US 2005263421 A1 US2005263421 A1 US 2005263421A1
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- United States
- Prior art keywords
- cassette
- lumen
- sterilant
- sterilizer
- carriage
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/208—Hydrogen peroxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
- A61L2/186—Peroxide solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Definitions
- This application relates to cassettes for delivering sterilant to an instrument sterilizer, and more particularly to such cassettes having encoded thereon a machine readable lumen claim.
- One popular method for sterilizing instruments is to contact the devices with a vapor phase chemical sterilant, such as hydrogen peroxide.
- a vapor phase chemical sterilant such as hydrogen peroxide.
- One particularly convenient and accurate method for delivering the liquid sterilant is to put a predetermined quantity of sterilant into a cassette and deliver the cassette to the sterilizer. The sterilizer then automatically extracts the sterilant from the cassette and uses it for sterilization procedure.
- a cassette would entail multiple cells containing equal amounts of liquid sterilant with a sterilization procedure employing the sterilant from one or more cells.
- Such a system is currently available in the STERRAD® sterilization system available from Advanced Sterilization Products in Irvine, Calif.
- a bar code on such a cassette It has been known to employ a bar code on such a cassette.
- a particular model of sterilizer employs a particular cassette design.
- the bar code on the cassette may include such information as the model number of the sterilizer for which it is designed and the expiration date of the cassette. Thus, if the wrong or an expired cassette is inserted, the sterilizer can determine this by reading the code and then reject the cassette.
- a cassette for a sterilizer comprises one or more cells in the cassette, at least one of the one or more cells containing a quantity of liquid sterilant.
- a bar code on the cassette is encoded with a lumen claim.
- the bar code has encoded therein an identifier for a type or model of sterilizer to which the lumen claim is related.
- the sterilant comprises hydrogen peroxide solution.
- the lumen claim in one aspect of the invention, specifies a length and internal diameter of a lumen. Additionally, it can specify a material from which the lumen is constructed.
- the encoding can be an identifier representative of the length and internal diameter, or the actual length and internal diameter can be encoded.
- the bar code resides on label attached to the cassette. Alternatively, it is printed onto the cassette.
- the cassette has a plurality of the cells.
- FIG. 1 is a block diagram of a sterilizer employing a cassette according to the present invention
- FIG. 2 is a rear perspective view of a cassette handling system according-to the present invention.
- FIG. 3 is a front perspective view of the cassette handling system of FIG. 2 ;
- FIG. 4 is a front perspective view of the cassette handling system of FIG. 2 showing a spent cassette collection box;
- FIG. 5 is a rear perspective view of the cassette handling system of FIG. 2 showing its carriage in the insert position;
- FIG. 6 is a rear perspective view of the cassette handling system of FIG. 2 showing its carriage as it moves toward the home position;
- FIG. 7 is a rear perspective view of the cassette handling system of FIG. 2 showing its carriage in position to read a bar code on the cassette;
- FIG. 8 is a rear perspective view of the cassette handling system of FIG. 2 showing its carriage in the home position;
- FIG. 9 is a front perspective view of the cassette handling system of FIG. 2 showing its carriage in position to tap the cassette's first cell;
- FIG. 10 is a cross sectional view of the cassette showing a cell therein;
- FIG. 11 is a front perspective view of the cassette handling system of FIG. 2 showing upper and lower needles on an extractor subsystem penetrating the first cell of the cassette;
- FIG. 12 is a front perspective view of the cassette handling system of FIG. 2 showing upper and lower needles on the extractor subsystem in position to penetrate the last cell of the cassette;
- FIG. 13 is a front perspective view of the cassette handling system of FIG. 2 showing the cassette being ejected therefrom;
- FIG. 14 is a flow chart of the cassette handling process
- FIG. 15 is a rear perspective view of an alternative embodiment of a cassette handling system of the present invention employing RFID technology
- FIG. 16 is a memory map of an RFID tag of the cassette shown in FIG. 15 ;
- FIG. 17 is a top plan view of an unfolded blank for forming the spent cassette collection box of FIG. 4 ;
- FIG. 18 is a perspective view of the blank of FIG. 17 folded to form the spent cassette collection box.
- FIG. 1 shows in block diagram form a vapor phase sterilizer 10 employing a cassette handling system 12 according to the present invention.
- the sterilizer 10 comprises a vacuum chamber 14 and a vacuum pump 16 for exhausting atmosphere therefrom.
- a vaporizer 18 receives liquid sterilant from the cassette handling system 12 and supplies it in vapor form to the vacuum chamber 14 .
- a screen grid electrode 20 is provided within the vacuum chamber 14 for exciting the contents into the plasma phase during a portion of the sterilization cycle.
- a micro filtered vent 22 and valve 24 allow sterile air to enter the vacuum chamber 14 and break the vacuum therein.
- a control system 28 ties in to all of the major components, sensors and the like within the sterilizer 10 to control the sterilization cycle.
- a typical sterilization cycle might include drawing a vacuum upon the vacuum chamber 14 and turning on power to the electrode 20 to evaporate and extract water from the vacuum chamber 14 .
- the electrode 20 is then powered off and a low vacuum of less than 1 torr drawn on the vacuum chamber 14 .
- Sterilant such as hydrogen peroxide solution, is vaporized by the vaporizer 18 and introduced into the vacuum chamber 14 where it diffuses into contact with the items to be sterilized and kills microorganisms thereon.
- power is again applied to the electrode 20 and the sterilant is driven into the plasma phase.
- the electrodes 20 are powered down and filtered air is drawn in through the valve 24 . This process can be repeated.
- the Jacobs et al. U.S. patent application, Publication No. 20030235511, incorporated herein by reference illustrates in detail such a cycle.
- the cassette handling system 12 comprises in gross, a carriage 32 for holding a cassette 34 , a lead screw 36 and motor 38 , an extractor subsystem 40 and a scanner 42 .
- the carriage 32 comprises a bottom panel 44 , a side panel 46 and top panel 48 along with small vertical flanges 50 and 52 on the top and bottom and top panels 48 and 44 , respectively, to capture the cassette 34 .
- the bottom, side and top panels 44 , 46 and 48 flare outwardly at an entrance 54 of the carriage to aid in insertion of the cassette 34 .
- Two spring catches 56 on the flanges 50 and 52 engage irregular surfaces of the cassette 34 to firmly position the cassette 34 within the carriage 32 .
- the carriage 32 travels along the lead screw 36 and is supported on an upper rail 58 .
- a lead screw nut 60 attached to the bottom panel 44 and having a threaded opening 62 and an unthreaded opening 63 receives the lead screw 36 and effects horizontal movement of the carriage 32 in response to rotations of the lead screw 36 .
- Flanges 64 extend outwardly from the top panel 48 and flanges 66 extend outwardly from the side panel 46 each having openings 69 for receiving the upper rail 58 .
- the motor 38 s preferable a stepping motor and connects to the lead screw 36 to precisely control the horizontal position of the cassette 34 relative to a frame 68 .
- the extraction assembly 40 comprises an upper needle 70 and a lower needle 72 , each being of a lumened configuration.
- the upper needle connects to an air pump 74 which can force air out through the upper needle 70 .
- the lower needle 72 connects to a valve 76 and from there is plumbed to the vaporizer 18 .
- the scanner 42 is oriented so as to be able to read a barcode 80 on the cassette 34 as well as a barcode 82 on a spent cassette collection box 84 .
- the scanner 42 Upon insertion of the cassette 34 into the carriage 32 the scanner 42 reads the cassette barcode 80 .
- the barcode 80 is preferably encoded with information regarding the contents of the cassette 34 , including lot numbers and expiration dates. This information can be used to determine whether the cassette 34 is fresh and of the correct type and whether the cassette 34 has been used in the system before and thus is at least partially empty.
- the code is communicated to the control system 28 which makes these determinations.
- the scanner 42 can also see the spent cassette collection box barcode 82 when the carriage 32 moves inwardly and away from the scanner 42 .
- Each spent cassette collection box 84 preferably has two barcodes 82 , one in each opposing corner so that the scanner 42 can see one of them regardless of which end of the spent cassette collection box 84 is inserted first.
- the spent cassettes 34 block the barcode 82 which alerts the control system 28 that there is no capacity for receiving additional spent cassettes 34 .
- this message will be output to a user, such as on a display screen (not shown). If the cassette 34 is empty it will not be ejected and no new cycles will be run until a spent cassette collection box 84 having capacity to receive a spent cassette 34 is placed into the sterilizer 10 .
- a forward flag 86 and rearward flag 88 project outwardly and downwardly from the carriage side panel 46 . They slide through a slot 90 in a slot sensor 92 which detects their presence within the slot 90 , such as by blocking a beam of light. Travel of the front flag 86 and rear flag 88 through the slot sensor 92 provides a reference location of the carriage 32 to the control system 28 .
- the top panel 48 of the carriage 32 can rotate about the upper rail 58 .
- a spring 94 between the top panel 48 and side panel 46 biases the top panel 48 downwardly to hold the cassette 34 within the carriage 32 .
- a disposing cam 96 sits behind the side panel 46 and aligns with an ejecting tab 98 which extends outwardly and downwardly from the top panel 48 and which can project through an opening 100 in the side panel 46 when the top panel 48 rotates upwardly.
- Such rotation of the top panel 48 releases its hold upon the cassette 34 and due to the ejecting tab 98 projecting through the opening 100 pushes the cassette 34 out of the carriage 32 and into the spent cassette collection box.
- the disposing cam 96 controls rotation of the top panel 48 . It comprises a generally triangular shape, having an outwardly facing side 102 , forwardly facing side 104 and rearwardly facing side 106 . Turning also now to FIG. 5 , it mounts for rotation upon an upwardly extending spindle 108 .
- a spring 110 biases the disposing cam 96 counterclockwise, urging the outwardly facing side 102 into contact with an abutment 112 . Inward movements of the carriage 32 allow the ejecting tab 98 to cam over the rearwardly facing side 106 of the disposing cam 96 , thus allowing the disposing cam 96 to rotate clockwise and allow the ejecting tab 98 to pass thereby without effecting rotation of the top panel 48 .
- outward movement of the carriage 32 causes the ejecting tab 98 to cam over the forwardly facing side 104 of the disposing cam 96 .
- the camming of the ejecting tab 98 thus causes it to move laterally toward the side panel 46 thereby rotating the top panel 48 upwardly and releasing the cassette 34 from the carriage 32 .
- the stepper motor 38 takes over and starts to move the carriage 32 inwardly.
- the scanner 42 scans the barcode 80 on the cassette 34 .
- the control system 28 interprets the information coming from the barcode 80 and determines whether the cassette 34 has been used in the sterilizer 10 before, whether the cassette contains fresh sterilant, and other data as appropriate.
- the information on the barcode 80 is encrypted to prevent unauthorized parties from creating cassettes which may not meet the quality standards necessary for proper sterilization.
- control system 28 rejects the cassette 34 a carriage 32 is moved sufficiently inwardly so as to pass the ejecting tab 98 past the disposing cam 96 and is then moved back to the insertion position shown in FIG. 5 to eject the rejected cassette 34 . If the cassette 34 is accepted, the carriage 32 continues inward movement to the home position as shown in FIG. 8 in which the rear flag 88 has just passed out of the slot sensor 92 .
- the cassette 34 comprises a plurality of cells 118 containing liquid sterilant 120 .
- a cassette may be employed.
- the cassette 34 shown comprises a hard outer shell 122 , preferably formed of an injection molded polymer, such as high impact polystyrene, high density polyethylene or high density polypropylene, which encloses the individual cells 118 , the cells 118 being formed of a blow molded polymer such as low density polyethylene.
- a more rigid material can be used to form the cassette cells 118 in which case the outer shell 122 could be omitted.
- an upper aperture 124 and lower aperture 126 through the shell 122 allows the upper and lower needles 70 and 72 to penetrate the shell.
- the cell 118 is formed of a material easily penetrated by the needles. If the cell 118 is formed of a more substantial material, a thinning of the material could be provided at the locations to be penetrated by the needles 70 and 72 .
- the control system 28 uses the home position of FIG. 8 as a reference position for positioning the various cells 118 in front of the extractor subsystem 40 .
- cell one has been placed in front of the extractor system 40 .
- an actuator 128 drives the extractor subsystem 40 toward the cassette 34 causing the upper and lower needles 70 and 72 to penetrate the upper and lower apertures 124 and 126 and enter the cell 118 .
- the air pump 74 drives air into the cell 118 through the upper needle 70 .
- the system waits a couple of seconds before starting the air pump 74 and opening the valve 76 to ensure proper placement and settling of the needles within the cell 118 .
- the sterilant 120 flows out through the lower needle 72 and is piped off to the vaporizer 18 . After a sufficient time to extract the sterilant 120 , the air pump 74 switches off and the actuator retracts the extractor subsystem 40 from the cassette 34 .
- the vaporizer 18 connects to the vacuum chamber 14 which allows the lower needle 72 to easily be placed at a pressure below atmospheric.
- the pump 74 can optionally be replaced by a valve (not shown) open to atmosphere, in which case the incoming atmospheric pressure air will provide the driving force to empty the cell 118 .
- one needle having two lumens therethrough would suffice.
- One of the lumens would provide pressurizing gas and one would extract liquid sterilant.
- a further alternative arrangement would be to pierce the cell 118 vertically, or substantially so, from an upper part of the cell 118 , preferably with such a double lumen needle. This would minimize leakage around the hole created by the needle entering the cell 118 . Such entry would also allow the tip of the needle to come closer to the lowest point of the cell 118 for maximum extraction efficiency.
- one method would be to position the needle extracting the sterilant, such as the lower needle 72 or the just mentioned double lumen needle, at the level in the cell 118 down to which extraction is desired. Liquid sterilant above the position would be extracted and sterilant below would remain. This would be particularly convenient with the just mentioned vertically traveling needle.
- the stepper motor 38 moves the cassette to position the next cell 118 in front of the extractor subsystem 40 and a new extraction takes place. Multiple extractions may be employed for a given sterilization cycle.
- the carriage 32 moves towards the insert position thus causing the ejecting tab 98 to cam over the disposing cam 96 to rotate the top panel 48 upwardly and project the ejecting tab 98 through the opening 100 to drive the cassette 34 out of the carriage 32 as described above and as shown in FIG. 13 .
- the cassette 34 falls into the spent cassette collection box 84 and the carriage 32 returns to the insertion position as shown in FIG. 5 .
- FIG. 14 shows, in block diagram form, the basic operation of the cassette handling system 12 .
- sterilizers and their cycle parameters have been optimized to enable sterilization of the most challenging loads possible so as to not unduly restrict which devices might be sterilized therein.
- Long narrow lumens being one of the most challenging areas to sterilize have become the de facto standard in defining the potency of a sterilization process, i.e. its ability to sterilize devices having a lumen of a certain diameter and length. The longer and narrower the lumen which can be sterilized, the more efficacious the sterilizer cycle.
- a sterilizer is thus said to achieve a lumen claim of lumen diameter by lumen length, as for instance 1 mm ⁇ 100 mm.
- the lumen claim can also include the material forming the lumen.
- the lumen claim will be the claim which has been approved by a regulatory agency such as the US Food and Drug Administration, but can represent merely the lumen which the sterilizer and cycle can effectively sterilize.
- sterilization entails a six log reduction in the challenge microorganisms.
- the preferred challenge microorganism is Geobacillus stearothermophilus.
- the sterilizer 10 may be desirable to run the sterilizer 10 in different cycles depending upon the devices loaded therein for sterilization.
- an operator selects a lumen claim when loading the sterilizer 10 based upon the most challenging lumen device being loaded and then enters that lumen claim into the control system 28 .
- the devices can be coded themselves, such as with a bar code which is scanned as the device is loaded, and the control system 28 selects the appropriate cycle to meet a particular lumen claim based upon the most challenging lumen device which was scanned.
- a set of lumen claim cycles programmed into the sterilizer might include the following: a) 1 mm ⁇ 1,000 mm, b) 1 mm ⁇ 500 mm, c) 2 mm ⁇ 100 mm, and d) no lumen.
- the cycles for the less demanding lumen claims can be adjusted, such as injecting less sterilant, employing a lower concentration sterilant, a shorter contact time, or a less demanding vacuum (higher pressure).
- employing a lower concentration sterilant can provide benefits in gentler processing of the instruments to be sterilized.
- cassettes 34 having loads of sterilant optimized for a given lumen claim cycle are provided.
- the lumen claim is encoded onto the barcode 80 along with other data such as the sterilizer model for which the cassette 34 is intended and the expiration date.
- a suggested data layout for the barcode 80 comprises the following fields: a) sterilizer model for which the cassette 34 is intended (three binary digits—associated with a look-up table); b) expiration date (eight binary digits representing the number of months from a fixed date); c) lumen claim (three binary digits—associated with a look-up table).
- the lumen claim could be represented by separate lumen internal diameter and length fields, preferably in millimeters and decimeters respectively.
- some lumens having different dimensions may nonetheless have equivalent processing requirements.
- one of the equivalent lumens would be coded onto the barcode 80 , with the sterilizer's control system being programmed with the equivalents. Many coding schemes are possible within the scope of the invention.
- Tables 1a and 1b illustrate how certain parameters of the cycle can be modified to treat particular lumens.
- TABLE 1a 173L chamber with two loads Time required to kill about 1 ⁇ 10 6 Geobacillus Peroxide Peroxide stearothermophilus Device concentration amount spores Stainless steel 59% wt 1 g 5 minutes Surface 1 mm ⁇ 1000 mm 50% wt 2 g 15 minutes TEFLON* lumen 1 mm ⁇ 125 mm, 59% wt 1.7 g 20 minutes 2 mm ⁇ 250 mm or 3 mm ⁇ 400 mm Stainless Steel lumen *polytetrafluoroethylene, TEFLON is a trademark of 3M Co.
- the control system 28 can be configured to take multiple inputs and use this information to determine how a subsequent sterilization cycle should be performed.
- Such inputs can include: whether the load is wrapped or unwrapped (such as in Central Supply Room “CSR” wrap), the weight of the load, the number of items (and more preferably the number of certain types of items such as rigid or flexible endoscopes, the materials of the load, such as the proportion of plastics, the presence or proportion of polymers highly absorbtive of hydrogen peroxide such as, but not limited to, polyamides, polyurethanes, silicone rubbers, PVCs, Polymethyl methacrylates and polysulfones, and whether full sterilization or merely high level disinfection is needed.
- Some of these inputs can be determined by the machine with addition of appropriate sensors, such as for example the weight of the load which can be determined via some form of scale preferably incorporated into the sterilizer 10 or via measuring plasma power.
- the sterilizer 10 has many sensors including those to measure temperature, pressure, sterilant concentration and plasma power. These in conjunction with the user inputs are used by the control system to adjust the parameter of the sterilization cycle in order to adequately treat the load in the most efficient manner.
- Table 2 illustrates how a cycle can be modified to for several user inputs. TABLE 2 Cycle Response to User Input Attributes of load Response Control mechanism Sterilization or high High level disinfection- Determine level disinfection low sterilant concentration sterilant/disinfectant or/and mass/shorter exposure concentration level and time quantity to reach sterilant Sterilization- high level required.
- Monitor sterilant concentration or/and concentration/amount by mass sterilant sensor and maintain at the required level Wrapped or unwrapped Unwrapped- low Determine load concentration/mass delivery sterilant/disinfectant Wrapped- higher concentration level and concentration/mass delivery quantity to reach sterilant level required.
- Loads contains materials Higher injection Monitor and maintain the that are a decomposer or mass/concentration and required absorber to the temperature may be required sterilant/disinfectant level.
- Load contains lumens: High concentration and/or Set concentration and short vs. long mass, longer exposure time pressure gradient levels and pre-processing pressure accordingly gradient
- the user would first choose between running one or more standard cycles, or one or more user programmed cycles, or enter load and process data to design a cycle. Under the option of entering load data the user could first select whether sterilization or high level disinfection is required. If sterilization is selected, the user would preferably enter whether the load contained wrapped containers or items. The user would second enter whether the load contained lumens or not. For a load lacking lumens the overall weight and materials in the load would be entered. These entries could be made item by item, or as an aggregate. For lumens, additional data such as the lumen length and internal diameter would be entered. Again, this data could be entered as the most challenging single lumen, or item by item.
- the user would enter load preparation information such as whether preheating or moisture removal steps should be taken with the load.
- the control system could recommend or determine whether these steps should be taken based upon the data entered. These steps can lengthen the overall process time and in some instances the user may wish to opt out of their use to speed the cycle.
- the user would enter data as to the source of sterilant (bulk or cassette), sterilant concentration, sterilant volume and type of sterilant. Again, some of this could rather be recommended or determined by the control system based upon the entered data, which could also provide the user with a message as to which type of cassette should be loaded for instance.
- information about residual removal would be entered, i.e.
- Determinations of cycle changes can be made based upon table look-ups employing cycle corrections based upon known cycle modifications related to load modifications, preferably backed up by test data. For instance, tests run on lumens of varying diameter and ID can determine exposure times and sterilant concentrations that produce reliable sterilization. In addition, calculations of integrated sterilant exposure (quantity and time) can be employed. For instance, experiments have shown that a particular lumen can be successfully sterilized by a particular integrated sterilant exposure; varying the quantity or time while maintaining the overall integrated exposure still achieves a reliable sterilization.
- the system of reading barcodes on the cassette 34 and spent cassette box 84 can be replaced with radio frequency identification tags, commonly known as RFID tags.
- An RFID system 130 is shown in FIG. 15 . It comprises a controller 132 connected via an SPDT reed relay 134 to a cassette insertion antenna 136 located on the carriage 32 and a cassette disposal antenna 138 located beneath the spend cassette box 84 .
- Each cassette 34 carries a cassette RFID tag 140 .
- each spent cassette collection box 84 carries a collection box RFID tag 142 .
- the controller 132 comprises a Texas Instruments multifunction reader module S 4100 and the RFID tags 140 and 42 comprise Texas Instruments RFID tag RI-101-112A each of which are available from Texas Instruments, Dallas, Tex.
- the control system 28 selects one of the antennas, as for instance the cassette insertion antenna 136 and sends a signal to the relay 134 to engage this antenna with the RFID controller 132 .
- the antenna reads the information stored on the cassette insertion RFID tag 140 which identifies the cassette 34 and its contents.
- the information read is similar to the information read using the barcode, however preferably, the RFID tag 140 has the ability to update the information stored thereon. Accordingly, additional data such as the filling status of individual cells 118 within the cassette 34 can be stored on the RFID tag.
- the control system 28 can be apprised of the status of each of the individual cells 118 within the cassette 34 . This allows the reuse of a partially used cassette 34 . Also, since the RFID tag 140 can hold more data than the barcode 80 , more data about the cassette 34 , its contents and manufacturing can be included thereon.
- the spent collection box antenna 138 reads the spent collection box RFID tag 142 to determine the presence or absence of the spent cassette collection box 84 .
- Other data such as a unique identifier for the box 84 , the capacity of the box 84 , how many cassettes 34 are currently in the box 84 and how many of the cells 118 therein are not empty can be included on the RFID tag 142 .
- the control system 28 can track how many cassettes 34 have been ejected into the box to determine whether it has room for more spent cassettes 34 .
- the antenna 138 can also read the cassette RFID tags 140 and count the number of cassettes 34 within the box 84 . When the box 84 is full the control system 28 alerts the operator, as by a message on a screen. This message can also include information regarding the cassettes 34 within the box 84 . For instance if not all of the cassettes 34 have been completely drained the operator can be informed of this to decide if more careful disposal may be indicated.
- RFID tags typically comprise an antenna and an integrated circuit produced in a thin form factor so they can be inconspicuously placed upon an object such as the cassette 34 . Radio frequency energy sent by the antennas 136 and 138 induce sufficient current within the antenna inside the RFID tags 140 and 142 to power the integrated circuit therein. Some types of RFID tags carry their own power source and have longer detection ranges, but that adds additional expense and is probably not justified for the present use.
- FIG. 16 shows the memory map for the memory within the RFID tags 140 and 142 .
- a 64-bit unique ID (UID) is set at the factory and cannot be changed. Each RFID tag has its own unique number here. Sixty-four 32-bit blocks can be programmed by the user. These can be populated with information such as the manufacture date, expiration date, product ID, serial number, lot numbers, manufacturing location, filling status of the cells, strength and type of sterilant, time spent within the sterilizer 10 and the like.
- the RFID tag 140 can optionally include temperature collection instrumentation and update that information on the tag. If design temperature profiles are exceeded, such as a maximum temperature or excessive temperature over a time period, then the cassette 34 can be rejected by the control system 28 . Temperature measuring RFID tags are available from KSW-Microtec, Dreseden, Germany and from Identec Solutions, Inc., Kelowna, British Columbia, Canada. The interior of the sterilizer 10 where the cassette 34 sits may be higher than ambient temperature. Thus, it may be beneficial to put a maximum residence time (on board shelf life) on the tag 140 or even to update on the tag 140 this time the cassette has already spent inside of the sterilizer.
- cassettes 34 having water or other fluids within one or more cells 118 may be beneficial to provide cassettes 34 having water or other fluids within one or more cells 118 . Information regarding the special nature of the cassette 34 and its contents could be written onto the RFID tag.
- the sterilizer may only require part of the contents of a cell 118 .
- a particular cycle may call for the contents of one and a half cells.
- the half filled nature of the cell 118 can be stored and then for the next cycle that cell 118 can be drained.
- communications between the tag 140 and 142 and the controller 132 are encrypted.
- the UID can be XORed with an eight-bit master key to form a diversified key for encrypting the data.
- Encryption algorithms such as the data encryption standard (DES) triple DES, asymmetrical encryption standard (AES) or RSA security can be used for the encryption.
- the RFID controller 132 reads the data and the algorithm in the control system 28 decrypts the data to reveal the stored information.
- cassette 34 could include an active transmitter and a power source (i.e. a battery) such as powered RFID tags or Bluetooth, 802.11b or other communication standard.
- a power source i.e. a battery
- the sterilizer 10 can be set up to communicate back to a central source, such as the manufacturer or distributor thereof, and provide information regarding its performance and the performance of the cassettes 34 .
- Poorly performing cassettes 34 could be identified, as for instance sterilant monitors in the sterilizer not detecting sterilant during a cycle thus indicating some failure such as an empty cassette or bad sterilant therein.
- An improperly manufactured batch of cassettes 34 could then be quickly identified and recalled. Such communication could occur over telephone, pager or wireless telephone networks or over the Internet.
- the spent cassette collection box 84 is preferably folded from a single sheet of printed cardboard or other stock.
- FIG. 17 shows an unfolded blank 150 and
- FIG. 18 shows the blank 150 folded to form the spent cassette collection box 84 .
- the blank 150 is divided by a series of fold lines (shown dashed) and cut lines into a bottom panel 152 , side panels 154 , end panels 156 and top flaps 158 .
- Folding tabs 160 extend laterally from the side panels 154 .
- additional folding tabs 162 extend laterally from the end panels 156 .
- Barcodes 82 are printed on the side panels 154 in a position to be visible in an upper interior corner of the spent cassette collection box 84 when it is folded into the configuration shown in FIG. 18 .
- a pair of top flap locking tabs 164 extend from the top flaps 158 and fit into slots 166 in the opposing top flap 158 when the box 84 is closed and into slots 168 at the intersection of the bottom panel 152 and side panel 154 when the box 84 is opened.
- the folding tabs 160 on the side panels 154 are folded upwardly and then the side panels 154 are folded upwardly, thereby aligning the folding tabs 160 with the intersection between the bottom panel 152 and the end panels 156 .
- the end panels 156 are then folded upwardly and the end panel folding tabs 162 are folded downwardly over the folding tabs 160 .
- Locking tabs 170 on the end panel folding tabs 162 fit into slots 172 at the intersection between the bottom panel 152 and end panels 156 .
- the top flaps 158 are folded downwardly to the outside and the locking tabs 164 fitted into the slots 168 .
- the top flaps 158 are folded upwardly over the top and the locking tabs 164 can then be fitted into the slots 166 on the opposing top flaps 158 .
- This unique folding arrangement allows spent cassettes 34 to fall into the open box 84 easily without the top flaps 158 getting in the way and also allows easy closure of the box 84 once it has become filled.
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Abstract
A cassette for a sterilizer has one or more cells containing a sterilant and carries a bar code which is encoded with a lumen claim. The lumen claim relates to a sterilization cycle for which the cassette is designed.
Description
- This application relates to cassettes for delivering sterilant to an instrument sterilizer, and more particularly to such cassettes having encoded thereon a machine readable lumen claim.
- One popular method for sterilizing instruments, such as medical devices, is to contact the devices with a vapor phase chemical sterilant, such as hydrogen peroxide. In many such sterilizers, it is preferred to deliver the sterilant in liquid form and vaporize it in the sterilizer. One particularly convenient and accurate method for delivering the liquid sterilant is to put a predetermined quantity of sterilant into a cassette and deliver the cassette to the sterilizer. The sterilizer then automatically extracts the sterilant from the cassette and uses it for sterilization procedure. Typically, such a cassette would entail multiple cells containing equal amounts of liquid sterilant with a sterilization procedure employing the sterilant from one or more cells. Such a system is currently available in the STERRAD® sterilization system available from Advanced Sterilization Products in Irvine, Calif.
- U.S. Pat. Nos. 4,817,800; 4,869,286; 4,899,519; 4,909,287; 4,913,196; 4,938,262; 4,941,518; 5,882,611; 5,887,716; and 6,412,340, each incorporated herein by reference, disclose such cassettes and a method for draining liquid sterilant from a cell within a cassette.
- It has been known to employ a bar code on such a cassette. Typically, a particular model of sterilizer employs a particular cassette design. The bar code on the cassette may include such information as the model number of the sterilizer for which it is designed and the expiration date of the cassette. Thus, if the wrong or an expired cassette is inserted, the sterilizer can determine this by reading the code and then reject the cassette.
- A cassette for a sterilizer according to the present invention comprises one or more cells in the cassette, at least one of the one or more cells containing a quantity of liquid sterilant. A bar code on the cassette is encoded with a lumen claim.
- Preferably, the bar code has encoded therein an identifier for a type or model of sterilizer to which the lumen claim is related.
- In one aspect of the invention, the sterilant comprises hydrogen peroxide solution.
- The lumen claim, in one aspect of the invention, specifies a length and internal diameter of a lumen. Additionally, it can specify a material from which the lumen is constructed. The encoding can be an identifier representative of the length and internal diameter, or the actual length and internal diameter can be encoded.
- Preferably, the bar code resides on label attached to the cassette. Alternatively, it is printed onto the cassette.
- In a preferred embodiment, the cassette has a plurality of the cells.
-
FIG. 1 is a block diagram of a sterilizer employing a cassette according to the present invention; -
FIG. 2 is a rear perspective view of a cassette handling system according-to the present invention; -
FIG. 3 is a front perspective view of the cassette handling system ofFIG. 2 ; -
FIG. 4 is a front perspective view of the cassette handling system ofFIG. 2 showing a spent cassette collection box; -
FIG. 5 is a rear perspective view of the cassette handling system ofFIG. 2 showing its carriage in the insert position; -
FIG. 6 is a rear perspective view of the cassette handling system ofFIG. 2 showing its carriage as it moves toward the home position; -
FIG. 7 is a rear perspective view of the cassette handling system ofFIG. 2 showing its carriage in position to read a bar code on the cassette; -
FIG. 8 is a rear perspective view of the cassette handling system ofFIG. 2 showing its carriage in the home position; -
FIG. 9 is a front perspective view of the cassette handling system ofFIG. 2 showing its carriage in position to tap the cassette's first cell; -
FIG. 10 is a cross sectional view of the cassette showing a cell therein; -
FIG. 11 is a front perspective view of the cassette handling system ofFIG. 2 showing upper and lower needles on an extractor subsystem penetrating the first cell of the cassette; -
FIG. 12 is a front perspective view of the cassette handling system ofFIG. 2 showing upper and lower needles on the extractor subsystem in position to penetrate the last cell of the cassette; -
FIG. 13 is a front perspective view of the cassette handling system ofFIG. 2 showing the cassette being ejected therefrom; -
FIG. 14 is a flow chart of the cassette handling process; -
FIG. 15 is a rear perspective view of an alternative embodiment of a cassette handling system of the present invention employing RFID technology; -
FIG. 16 is a memory map of an RFID tag of the cassette shown inFIG. 15 ; -
FIG. 17 is a top plan view of an unfolded blank for forming the spent cassette collection box ofFIG. 4 ; and -
FIG. 18 is a perspective view of the blank ofFIG. 17 folded to form the spent cassette collection box. - Sterilizer Overall Configuration
-
FIG. 1 shows in block diagram form avapor phase sterilizer 10 employing acassette handling system 12 according to the present invention. Thesterilizer 10 comprises avacuum chamber 14 and avacuum pump 16 for exhausting atmosphere therefrom. Avaporizer 18 receives liquid sterilant from thecassette handling system 12 and supplies it in vapor form to thevacuum chamber 14. Ascreen grid electrode 20 is provided within thevacuum chamber 14 for exciting the contents into the plasma phase during a portion of the sterilization cycle. A micro filteredvent 22 andvalve 24 allow sterile air to enter thevacuum chamber 14 and break the vacuum therein. Acontrol system 28 ties in to all of the major components, sensors and the like within thesterilizer 10 to control the sterilization cycle. - A typical sterilization cycle might include drawing a vacuum upon the
vacuum chamber 14 and turning on power to theelectrode 20 to evaporate and extract water from thevacuum chamber 14. Theelectrode 20 is then powered off and a low vacuum of less than 1 torr drawn on thevacuum chamber 14. Sterilant, such as hydrogen peroxide solution, is vaporized by thevaporizer 18 and introduced into thevacuum chamber 14 where it diffuses into contact with the items to be sterilized and kills microorganisms thereon. Near the end of the cycle, power is again applied to theelectrode 20 and the sterilant is driven into the plasma phase. Theelectrodes 20 are powered down and filtered air is drawn in through thevalve 24. This process can be repeated. The Jacobs et al. U.S. patent application, Publication No. 20030235511, incorporated herein by reference, illustrates in detail such a cycle. - Cassette Handling System
- Turning also to FIGS. 2 to 4, the
cassette handling system 12 according to the present invention is shown. It comprises in gross, acarriage 32 for holding acassette 34, alead screw 36 andmotor 38, anextractor subsystem 40 and ascanner 42. - The
carriage 32 comprises abottom panel 44, aside panel 46 andtop panel 48 along with smallvertical flanges top panels cassette 34. The bottom, side andtop panels entrance 54 of the carriage to aid in insertion of thecassette 34. Two spring catches 56 on theflanges cassette 34 to firmly position thecassette 34 within thecarriage 32. - The
carriage 32 travels along thelead screw 36 and is supported on anupper rail 58. Alead screw nut 60 attached to thebottom panel 44 and having a threadedopening 62 and an unthreadedopening 63 receives thelead screw 36 and effects horizontal movement of thecarriage 32 in response to rotations of thelead screw 36.Flanges 64 extend outwardly from thetop panel 48 andflanges 66 extend outwardly from theside panel 46 each havingopenings 69 for receiving theupper rail 58. The motor 38 s preferable a stepping motor and connects to thelead screw 36 to precisely control the horizontal position of thecassette 34 relative to aframe 68. - The
extraction assembly 40 comprises anupper needle 70 and alower needle 72, each being of a lumened configuration. The upper needle connects to anair pump 74 which can force air out through theupper needle 70. Thelower needle 72 connects to avalve 76 and from there is plumbed to thevaporizer 18. - The
scanner 42 is oriented so as to be able to read abarcode 80 on thecassette 34 as well as abarcode 82 on a spentcassette collection box 84. Upon insertion of thecassette 34 into thecarriage 32 thescanner 42 reads thecassette barcode 80. Thebarcode 80 is preferably encoded with information regarding the contents of thecassette 34, including lot numbers and expiration dates. This information can be used to determine whether thecassette 34 is fresh and of the correct type and whether thecassette 34 has been used in the system before and thus is at least partially empty. The code is communicated to thecontrol system 28 which makes these determinations. - The
scanner 42 can also see the spent cassettecollection box barcode 82 when thecarriage 32 moves inwardly and away from thescanner 42. Each spentcassette collection box 84 preferably has twobarcodes 82, one in each opposing corner so that thescanner 42 can see one of them regardless of which end of the spentcassette collection box 84 is inserted first. With the spentcassette collection box 84 filled, the spentcassettes 34 block thebarcode 82 which alerts thecontrol system 28 that there is no capacity for receiving additional spentcassettes 34. Preferably this message will be output to a user, such as on a display screen (not shown). If thecassette 34 is empty it will not be ejected and no new cycles will be run until a spentcassette collection box 84 having capacity to receive a spentcassette 34 is placed into thesterilizer 10. - A
forward flag 86 andrearward flag 88 project outwardly and downwardly from thecarriage side panel 46. They slide through aslot 90 in aslot sensor 92 which detects their presence within theslot 90, such as by blocking a beam of light. Travel of thefront flag 86 andrear flag 88 through theslot sensor 92 provides a reference location of thecarriage 32 to thecontrol system 28. - The
top panel 48 of thecarriage 32 can rotate about theupper rail 58. Aspring 94 between thetop panel 48 andside panel 46 biases thetop panel 48 downwardly to hold thecassette 34 within thecarriage 32. A disposingcam 96 sits behind theside panel 46 and aligns with an ejectingtab 98 which extends outwardly and downwardly from thetop panel 48 and which can project through anopening 100 in theside panel 46 when thetop panel 48 rotates upwardly. Such rotation of thetop panel 48 releases its hold upon thecassette 34 and due to the ejectingtab 98 projecting through theopening 100 pushes thecassette 34 out of thecarriage 32 and into the spent cassette collection box. - The disposing
cam 96 controls rotation of thetop panel 48. It comprises a generally triangular shape, having an outwardly facingside 102, forwardly facingside 104 and rearwardly facingside 106. Turning also now toFIG. 5 , it mounts for rotation upon an upwardly extendingspindle 108. Aspring 110 biases the disposingcam 96 counterclockwise, urging the outwardly facingside 102 into contact with anabutment 112. Inward movements of thecarriage 32 allow theejecting tab 98 to cam over the rearwardly facingside 106 of the disposingcam 96, thus allowing the disposingcam 96 to rotate clockwise and allow theejecting tab 98 to pass thereby without effecting rotation of thetop panel 48. However, outward movement of thecarriage 32 causes the ejectingtab 98 to cam over the forwardly facingside 104 of the disposingcam 96. During such motion contact between the outwardlyfacings side 102 of the disposingcam 96 and theabutment 112 prevents rotation of the disposingcam 96. The camming of the ejectingtab 98 thus causes it to move laterally toward theside panel 46 thereby rotating thetop panel 48 upwardly and releasing thecassette 34 from thecarriage 32. - Prior to inserting the
cassette 34 thecarriage 32 is fully retracted to its outward position (to the left as shown inFIG. 5 ). In this position also, aforward end 114 on thelead screw nut 60 engages astop 116 thus positively locating the position of thecarriage 32. Turning also now toFIG. 6 , manual insertion of thecassette 34 causes thecarriage 32 to move inwardly (to the right as shown inFIG. 6 ) and moves thefront flag 86 into theslot sensor 92. This movement is preferably caused by the physical force from inserting thecassette 34, however, a torque or other sensor could be applied to allow the steppingmotor 38 to take over this movement upon feeling the force of thecassette 34 being inserted into thecarriage 32. Allowing this movement to come from the force of the insertion of thecassette 34 ensures that thecassette 34 is fully seated within thecarriage 32 before the movement begins. - Once the
front flag 86 is read by theslot sensor 92 thestepper motor 38 takes over and starts to move thecarriage 32 inwardly. Turning also now toFIG. 7 , during this stage, thescanner 42 scans thebarcode 80 on thecassette 34. Thecontrol system 28 interprets the information coming from thebarcode 80 and determines whether thecassette 34 has been used in thesterilizer 10 before, whether the cassette contains fresh sterilant, and other data as appropriate. Preferably, the information on thebarcode 80 is encrypted to prevent unauthorized parties from creating cassettes which may not meet the quality standards necessary for proper sterilization. - If the
control system 28 rejects the cassette 34 acarriage 32 is moved sufficiently inwardly so as to pass the ejectingtab 98 past the disposingcam 96 and is then moved back to the insertion position shown inFIG. 5 to eject the rejectedcassette 34. If thecassette 34 is accepted, thecarriage 32 continues inward movement to the home position as shown inFIG. 8 in which therear flag 88 has just passed out of theslot sensor 92. - Turning also now to
FIGS. 9 and 10 , thecassette 34 comprises a plurality ofcells 118 containingliquid sterilant 120. Various structures of a cassette may be employed. Thecassette 34 shown comprises a hardouter shell 122, preferably formed of an injection molded polymer, such as high impact polystyrene, high density polyethylene or high density polypropylene, which encloses theindividual cells 118, thecells 118 being formed of a blow molded polymer such as low density polyethylene. However, a more rigid material can be used to form thecassette cells 118 in which case theouter shell 122 could be omitted. In thecassette 34 shown, anupper aperture 124 andlower aperture 126 through theshell 122 allows the upper andlower needles cell 118 is formed of a material easily penetrated by the needles. If thecell 118 is formed of a more substantial material, a thinning of the material could be provided at the locations to be penetrated by theneedles - The
control system 28 uses the home position ofFIG. 8 as a reference position for positioning thevarious cells 118 in front of theextractor subsystem 40. By moving the carriage 32 a predetermined amount from the home position a givencell 118 can be brought to face theextractor system 40. InFIG. 9 , cell one has been placed in front of theextractor system 40. Turning also now toFIG. 11 , anactuator 128 drives theextractor subsystem 40 toward thecassette 34 causing the upper andlower needles lower apertures cell 118. After the needles have fully extended, theair pump 74 drives air into thecell 118 through theupper needle 70. The system waits a couple of seconds before starting theair pump 74 and opening thevalve 76 to ensure proper placement and settling of the needles within thecell 118. Thesterilant 120 flows out through thelower needle 72 and is piped off to thevaporizer 18. After a sufficient time to extract thesterilant 120, theair pump 74 switches off and the actuator retracts theextractor subsystem 40 from thecassette 34. - The
vaporizer 18 connects to thevacuum chamber 14 which allows thelower needle 72 to easily be placed at a pressure below atmospheric. Thus, thepump 74 can optionally be replaced by a valve (not shown) open to atmosphere, in which case the incoming atmospheric pressure air will provide the driving force to empty thecell 118. - Rather than employ upper and
lower needles cell 118 vertically, or substantially so, from an upper part of thecell 118, preferably with such a double lumen needle. This would minimize leakage around the hole created by the needle entering thecell 118. Such entry would also allow the tip of the needle to come closer to the lowest point of thecell 118 for maximum extraction efficiency. If one desired to extract less than all of the contents of thecell 118, one method would be to position the needle extracting the sterilant, such as thelower needle 72 or the just mentioned double lumen needle, at the level in thecell 118 down to which extraction is desired. Liquid sterilant above the position would be extracted and sterilant below would remain. This would be particularly convenient with the just mentioned vertically traveling needle. - Turning also to
FIG. 12 , each time thecontrol system 28 determines that a new dose ofsterilant 120 is required, thestepper motor 38 moves the cassette to position thenext cell 118 in front of theextractor subsystem 40 and a new extraction takes place. Multiple extractions may be employed for a given sterilization cycle. When thecassette 34 has been depleted, thecarriage 32 moves towards the insert position thus causing the ejectingtab 98 to cam over the disposingcam 96 to rotate thetop panel 48 upwardly and project the ejectingtab 98 through theopening 100 to drive thecassette 34 out of thecarriage 32 as described above and as shown inFIG. 13 . Thecassette 34 falls into the spentcassette collection box 84 and thecarriage 32 returns to the insertion position as shown inFIG. 5 . - The foregoing discussion described the operation of the cassette handling system in some detail.
FIG. 14 shows, in block diagram form, the basic operation of thecassette handling system 12. - Lumen Claim
- Typically, sterilizers and their cycle parameters have been optimized to enable sterilization of the most challenging loads possible so as to not unduly restrict which devices might be sterilized therein. Long narrow lumens being one of the most challenging areas to sterilize have become the de facto standard in defining the potency of a sterilization process, i.e. its ability to sterilize devices having a lumen of a certain diameter and length. The longer and narrower the lumen which can be sterilized, the more efficacious the sterilizer cycle. A sterilizer is thus said to achieve a lumen claim of lumen diameter by lumen length, as for
instance 1 mm×100 mm. The lumen claim can also include the material forming the lumen. Typically, the lumen claim will be the claim which has been approved by a regulatory agency such as the US Food and Drug Administration, but can represent merely the lumen which the sterilizer and cycle can effectively sterilize. Typically, sterilization entails a six log reduction in the challenge microorganisms. In hydrogen peroxide based sterilization systems the preferred challenge microorganism is Geobacillus stearothermophilus. - Rather than always run the sterilizer to achieve its maximum lumen claim, it may be desirable to run the
sterilizer 10 in different cycles depending upon the devices loaded therein for sterilization. Preferably, an operator selects a lumen claim when loading thesterilizer 10 based upon the most challenging lumen device being loaded and then enters that lumen claim into thecontrol system 28. Alternatively, the devices can be coded themselves, such as with a bar code which is scanned as the device is loaded, and thecontrol system 28 selects the appropriate cycle to meet a particular lumen claim based upon the most challenging lumen device which was scanned. A set of lumen claim cycles programmed into the sterilizer might include the following: a) 1 mm×1,000 mm, b) 1 mm×500 mm, c) 2 mm×100 mm, and d) no lumen. The cycles for the less demanding lumen claims can be adjusted, such as injecting less sterilant, employing a lower concentration sterilant, a shorter contact time, or a less demanding vacuum (higher pressure). In general, employing a lower concentration sterilant can provide benefits in gentler processing of the instruments to be sterilized. - To provide flexibility in optimizing differing lumen sterilization cycles, preferably cassettes 34 having loads of sterilant optimized for a given lumen claim cycle are provided. Preferably, the lumen claim is encoded onto the
barcode 80 along with other data such as the sterilizer model for which thecassette 34 is intended and the expiration date. - A suggested data layout for the
barcode 80 comprises the following fields: a) sterilizer model for which thecassette 34 is intended (three binary digits—associated with a look-up table); b) expiration date (eight binary digits representing the number of months from a fixed date); c) lumen claim (three binary digits—associated with a look-up table). Alternatively, the lumen claim could be represented by separate lumen internal diameter and length fields, preferably in millimeters and decimeters respectively. Further, as illustrated in the last row of Table la some lumens having different dimensions may nonetheless have equivalent processing requirements. Preferably, one of the equivalent lumens would be coded onto thebarcode 80, with the sterilizer's control system being programmed with the equivalents. Many coding schemes are possible within the scope of the invention. - Tables 1a and 1b illustrate how certain parameters of the cycle can be modified to treat particular lumens.
TABLE 1a 173L chamber with two loads Time required to kill about 1 × 106 Geobacillus Peroxide Peroxide stearothermophilus Device concentration amount spores Stainless steel 59% wt 1 g 5 minutes Surface 1 mm × 1000 mm 50% wt 2 g 15 minutes TEFLON* lumen 1 mm × 125 mm, 59% wt 1.7 g 20 minutes 2 mm × 250 mm or 3 mm × 400 mm Stainless Steel lumen
*polytetrafluoroethylene, TEFLON is a trademark of 3M Co.
-
TABLE 1b 51L chamber with one load Time required to kill about 1 × 106 Geobacillus Peroxide Peroxide stearothermophilus Device concentration amount spores 2 mm × 400 mm 90% wt 0.23 g 3 minutes Stainless Steel lumen 1 mm × 150 mm 90% wt 0.34 g 3 minutes Stainless Steel lumen 1 mm × 500 mm 90% wt 0.45 g 7 minutes Stainless Steel lumen 1 mm × 350 mm 90% wt 0.45 g 3 minutes TEFLON* lumen
8*polytetrafluoroethylene, TEFLON is a trademark of 3M Co.
- Beyond merely entering lumen data, the
control system 28 can be configured to take multiple inputs and use this information to determine how a subsequent sterilization cycle should be performed. Such inputs can include: whether the load is wrapped or unwrapped (such as in Central Supply Room “CSR” wrap), the weight of the load, the number of items (and more preferably the number of certain types of items such as rigid or flexible endoscopes, the materials of the load, such as the proportion of plastics, the presence or proportion of polymers highly absorbtive of hydrogen peroxide such as, but not limited to, polyamides, polyurethanes, silicone rubbers, PVCs, Polymethyl methacrylates and polysulfones, and whether full sterilization or merely high level disinfection is needed. Some of these inputs can be determined by the machine with addition of appropriate sensors, such as for example the weight of the load which can be determined via some form of scale preferably incorporated into thesterilizer 10 or via measuring plasma power. - The
sterilizer 10 has many sensors including those to measure temperature, pressure, sterilant concentration and plasma power. These in conjunction with the user inputs are used by the control system to adjust the parameter of the sterilization cycle in order to adequately treat the load in the most efficient manner. Table 2 illustrates how a cycle can be modified to for several user inputs.TABLE 2 Cycle Response to User Input Attributes of load Response Control mechanism Sterilization or high High level disinfection- Determine level disinfection low sterilant concentration sterilant/disinfectant or/and mass/shorter exposure concentration level and time quantity to reach sterilant Sterilization- high level required. Monitor sterilant concentration or/and concentration/amount by mass sterilant sensor and maintain at the required level Wrapped or unwrapped Unwrapped- low Determine load concentration/mass delivery sterilant/disinfectant Wrapped- higher concentration level and concentration/mass delivery quantity to reach sterilant level required. Monitor concentration/amount by sterilant sensor and maintain at the required level Load volume and weight High volume: possibly more Monitor and maintain the absorption required High weight: possibly higher sterilant/disinfectant condensation concentration level. Set temperature at higher level to reduce absorption and condensation effects. Pre- heat the load if necessary. High venting/residual removal treatment. Loads contains materials Higher injection Monitor and maintain the that are a decomposer or mass/concentration and required absorber to the temperature may be required sterilant/disinfectant level. sterilant/disinfectant High venting/residual removal treatment if excessive absorb is present (Identify from sterilant concentration sensor output) Load contains lumens: High concentration and/or Set concentration and short vs. long mass, longer exposure time pressure gradient levels and pre-processing pressure accordingly gradient - In one aspect of the invention, the user would first choose between running one or more standard cycles, or one or more user programmed cycles, or enter load and process data to design a cycle. Under the option of entering load data the user could first select whether sterilization or high level disinfection is required. If sterilization is selected, the user would preferably enter whether the load contained wrapped containers or items. The user would second enter whether the load contained lumens or not. For a load lacking lumens the overall weight and materials in the load would be entered. These entries could be made item by item, or as an aggregate. For lumens, additional data such as the lumen length and internal diameter would be entered. Again, this data could be entered as the most challenging single lumen, or item by item. Thirdly, the user would enter load preparation information such as whether preheating or moisture removal steps should be taken with the load. Alternatively, the control system could recommend or determine whether these steps should be taken based upon the data entered. These steps can lengthen the overall process time and in some instances the user may wish to opt out of their use to speed the cycle. Fourth, the user would enter data as to the source of sterilant (bulk or cassette), sterilant concentration, sterilant volume and type of sterilant. Again, some of this could rather be recommended or determined by the control system based upon the entered data, which could also provide the user with a message as to which type of cassette should be loaded for instance. Finally, information about residual removal would be entered, i.e. whether a residual removal step should be taken at the end of the cycle and whether heat, plasma, sterile air purging, vacuum or some combination thereof should be employed. Again, this information could rather be recommended or determined by the control system based upon the data entered. The user would have the option of saving this cycle set-up so that it could be chosen from a cycle menu for later cycles of similar devices. Names could be provided to the cycle set-up, such as by procedure instrument set, to allow easy retrieval of the appropriate cycle in the future.
- Determinations of cycle changes can be made based upon table look-ups employing cycle corrections based upon known cycle modifications related to load modifications, preferably backed up by test data. For instance, tests run on lumens of varying diameter and ID can determine exposure times and sterilant concentrations that produce reliable sterilization. In addition, calculations of integrated sterilant exposure (quantity and time) can be employed. For instance, experiments have shown that a particular lumen can be successfully sterilized by a particular integrated sterilant exposure; varying the quantity or time while maintaining the overall integrated exposure still achieves a reliable sterilization.
- The system of reading barcodes on the
cassette 34 and spentcassette box 84 can be replaced with radio frequency identification tags, commonly known as RFID tags. AnRFID system 130 is shown inFIG. 15 . It comprises acontroller 132 connected via anSPDT reed relay 134 to acassette insertion antenna 136 located on thecarriage 32 and acassette disposal antenna 138 located beneath thespend cassette box 84. Eachcassette 34 carries acassette RFID tag 140. Similarly, each spentcassette collection box 84 carries a collectionbox RFID tag 142. Preferably, thecontroller 132 comprises a Texas Instruments multifunction reader module S4100 and the RFID tags 140 and 42 comprise Texas Instruments RFID tag RI-101-112A each of which are available from Texas Instruments, Dallas, Tex. - The control system 28 (
FIG. 1 ) selects one of the antennas, as for instance thecassette insertion antenna 136 and sends a signal to therelay 134 to engage this antenna with theRFID controller 132. The antenna reads the information stored on the cassetteinsertion RFID tag 140 which identifies thecassette 34 and its contents. The information read is similar to the information read using the barcode, however preferably, theRFID tag 140 has the ability to update the information stored thereon. Accordingly, additional data such as the filling status ofindividual cells 118 within thecassette 34 can be stored on the RFID tag. Thus, if thecassette 34 is removed and then reinserted into thesterilizer 10, or even intodifferent sterilizer 10, thecontrol system 28 can be apprised of the status of each of theindividual cells 118 within thecassette 34. This allows the reuse of a partially usedcassette 34. Also, since theRFID tag 140 can hold more data than thebarcode 80, more data about thecassette 34, its contents and manufacturing can be included thereon. - The spent
collection box antenna 138 reads the spent collectionbox RFID tag 142 to determine the presence or absence of the spentcassette collection box 84. Other data such as a unique identifier for thebox 84, the capacity of thebox 84, howmany cassettes 34 are currently in thebox 84 and how many of thecells 118 therein are not empty can be included on theRFID tag 142. Thecontrol system 28 can track howmany cassettes 34 have been ejected into the box to determine whether it has room for morespent cassettes 34. Theantenna 138 can also read the cassette RFID tags 140 and count the number ofcassettes 34 within thebox 84. When thebox 84 is full thecontrol system 28 alerts the operator, as by a message on a screen. This message can also include information regarding thecassettes 34 within thebox 84. For instance if not all of thecassettes 34 have been completely drained the operator can be informed of this to decide if more careful disposal may be indicated. - RFID technology is disclosed in the following U.S. Patents, each of which is incorporated herein by reference: U.S. Pat. Nos. 6,600,420; 6,600,418; 5,378,880; 5,565,846; 5,347,280; 5,541,604; 4,442,507; 4,796,074; 5,095,362; 5,296,722; 5,407,851; 5,528,222; 5,550,547; 5,521,601; 5,682,143 and 5,625,341.
- RFID tags typically comprise an antenna and an integrated circuit produced in a thin form factor so they can be inconspicuously placed upon an object such as the
cassette 34. Radio frequency energy sent by theantennas -
FIG. 16 shows the memory map for the memory within the RFID tags 140 and 142. A 64-bit unique ID (UID) is set at the factory and cannot be changed. Each RFID tag has its own unique number here. Sixty-four 32-bit blocks can be programmed by the user. These can be populated with information such as the manufacture date, expiration date, product ID, serial number, lot numbers, manufacturing location, filling status of the cells, strength and type of sterilant, time spent within thesterilizer 10 and the like. - Some sterilants are affected by heat. The
RFID tag 140 can optionally include temperature collection instrumentation and update that information on the tag. If design temperature profiles are exceeded, such as a maximum temperature or excessive temperature over a time period, then thecassette 34 can be rejected by thecontrol system 28. Temperature measuring RFID tags are available from KSW-Microtec, Dreseden, Germany and from Identec Solutions, Inc., Kelowna, British Columbia, Canada. The interior of thesterilizer 10 where thecassette 34 sits may be higher than ambient temperature. Thus, it may be beneficial to put a maximum residence time (on board shelf life) on thetag 140 or even to update on thetag 140 this time the cassette has already spent inside of the sterilizer. - To test sterilant measuring equipment in the
sterilizer 10, it may be beneficial to providecassettes 34 having water or other fluids within one ormore cells 118. Information regarding the special nature of thecassette 34 and its contents could be written onto the RFID tag. - During a cycle the sterilizer may only require part of the contents of a
cell 118. For instance, a particular cycle may call for the contents of one and a half cells. The half filled nature of thecell 118 can be stored and then for the next cycle thatcell 118 can be drained. - Preferably, communications between the
tag controller 132 are encrypted. For instance, the UID can be XORed with an eight-bit master key to form a diversified key for encrypting the data. Encryption algorithms such as the data encryption standard (DES) triple DES, asymmetrical encryption standard (AES) or RSA security can be used for the encryption. TheRFID controller 132 reads the data and the algorithm in thecontrol system 28 decrypts the data to reveal the stored information. - Other methods could be used to communicate between the
cassette 34 and thesterilizer 10. For instance information could be stored magnetically on thecassette 34, such as with a magnetic encoded strip, and be read by a magnetic reader on the sterilizer. Wireless technology is becoming cheaper every day and it is envisioned that thecassette 34 could include an active transmitter and a power source (i.e. a battery) such as powered RFID tags or Bluetooth, 802.11b or other communication standard. - Further, the
sterilizer 10 can be set up to communicate back to a central source, such as the manufacturer or distributor thereof, and provide information regarding its performance and the performance of thecassettes 34. Poorly performingcassettes 34 could be identified, as for instance sterilant monitors in the sterilizer not detecting sterilant during a cycle thus indicating some failure such as an empty cassette or bad sterilant therein. An improperly manufactured batch ofcassettes 34 could then be quickly identified and recalled. Such communication could occur over telephone, pager or wireless telephone networks or over the Internet. - Turning now also to
FIGS. 17 and 18 , the spentcassette collection box 84 is preferably folded from a single sheet of printed cardboard or other stock.FIG. 17 shows an unfolded blank 150 andFIG. 18 shows the blank 150 folded to form the spentcassette collection box 84. - The blank 150 is divided by a series of fold lines (shown dashed) and cut lines into a
bottom panel 152,side panels 154,end panels 156 andtop flaps 158. Foldingtabs 160 extend laterally from theside panels 154. additionalfolding tabs 162 extend laterally from theend panels 156.Barcodes 82 are printed on theside panels 154 in a position to be visible in an upper interior corner of the spentcassette collection box 84 when it is folded into the configuration shown inFIG. 18 . A pair of topflap locking tabs 164 extend from thetop flaps 158 and fit intoslots 166 in the opposingtop flap 158 when thebox 84 is closed and intoslots 168 at the intersection of thebottom panel 152 andside panel 154 when thebox 84 is opened. - To fold the box, the
folding tabs 160 on theside panels 154 are folded upwardly and then theside panels 154 are folded upwardly, thereby aligning thefolding tabs 160 with the intersection between thebottom panel 152 and theend panels 156. Theend panels 156 are then folded upwardly and the endpanel folding tabs 162 are folded downwardly over thefolding tabs 160. Lockingtabs 170 on the endpanel folding tabs 162 fit intoslots 172 at the intersection between thebottom panel 152 and endpanels 156. - To place the
box 84 into the open position as shown inFIG. 18 , thetop flaps 158 are folded downwardly to the outside and the lockingtabs 164 fitted into theslots 168. Once thebox 84 is filled with spent cassettes, thetop flaps 158 are folded upwardly over the top and the lockingtabs 164 can then be fitted into theslots 166 on the opposing top flaps 158. This unique folding arrangement allows spentcassettes 34 to fall into theopen box 84 easily without thetop flaps 158 getting in the way and also allows easy closure of thebox 84 once it has become filled. - 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.
Claims (10)
1. A cassette for a sterilizer, the cassette comprising:
one or more cells in the cassette, at least one of the one or more cells containing a quantity of liquid sterilant; and
a bar code on the cassette, the bar code having encoded therein a lumen claim.
2. A cassette according to claim 1 wherein the bar code has encoded therein an identifier for a type or model of sterilizer to which the lumen claim is related.
3. A cassette according to claim 1 wherein the sterilant comprises hydrogen peroxide solution.
4. A cassette according to claim 1 wherein the lumen claim specifies a length and internal diameter of a lumen.
5. A cassette according to claim 4 wherein the lumen claim specifies a material from which the lumen is constructed.
6. A cassette according to claim 1 wherein the bar code has encoded therein a length and an internal diameter for the lumen claim.
7. A cassette according to claim 6 wherein the bar code has encoded therein a material for the lumen claim.
8. A cassette according to claim 1 wherein the bar code is on label attached to the cassette.
9. A cassette according to claim 1 wherein the bar code is printed onto the cassette.
10. A cassette according to claim 1 comprising a plurality of the cells.
Priority Applications (19)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/856,435 US20050263421A1 (en) | 2004-05-28 | 2004-05-28 | Cassette with encoded lumen claim |
US10/978,034 US20050263422A1 (en) | 2004-05-28 | 2004-10-29 | Cassette assembly |
AU2005201907A AU2005201907A1 (en) | 2004-05-28 | 2005-05-05 | Cassette assembly |
CA2507134A CA2507134C (en) | 2004-05-28 | 2005-05-12 | Cassette assembly |
AU2005202039A AU2005202039B2 (en) | 2004-05-28 | 2005-05-12 | Cassette assembly |
BR0502073-5A BRPI0502073A (en) | 2004-05-28 | 2005-05-25 | Case set |
ZA200504313A ZA200504313B (en) | 2004-05-28 | 2005-05-26 | Cassette assembly |
AT05253306T ATE401914T1 (en) | 2004-05-28 | 2005-05-27 | CASSETTE ARRANGEMENT |
RU2005116206/15A RU2385165C2 (en) | 2004-05-28 | 2005-05-27 | Cartrige unit |
ES05253306T ES2310322T3 (en) | 2004-05-28 | 2005-05-27 | ASSEMBLY OF CASSETS. |
CO05051944A CO5590191A1 (en) | 2004-05-28 | 2005-05-27 | CARTRIDGE ASSEMBLY |
TW094117331A TW200538166A (en) | 2004-05-28 | 2005-05-27 | Cassette assembly |
KR1020050044839A KR101205808B1 (en) | 2004-05-28 | 2005-05-27 | Cassette assembly |
MXPA05005710A MXPA05005710A (en) | 2004-05-28 | 2005-05-27 | Cassette assembly. |
DE602005008307T DE602005008307D1 (en) | 2004-05-28 | 2005-05-27 | cassette assembly |
JP2005156026A JP4767587B2 (en) | 2004-05-28 | 2005-05-27 | Cassette for delivering sterilant to surgical instrument sterilizer |
ARP050102194A AR055464A1 (en) | 2004-05-28 | 2005-05-27 | CARTRIDGE ASSEMBLY |
EP05253306A EP1600173B1 (en) | 2004-05-28 | 2005-05-27 | Cassette assembly |
CN200510074049A CN100574812C (en) | 2004-05-28 | 2005-05-30 | Cassette assembly |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/856,435 US20050263421A1 (en) | 2004-05-28 | 2004-05-28 | Cassette with encoded lumen claim |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/978,034 Continuation-In-Part US20050263422A1 (en) | 2004-05-28 | 2004-10-29 | Cassette assembly |
Publications (1)
Publication Number | Publication Date |
---|---|
US20050263421A1 true US20050263421A1 (en) | 2005-12-01 |
Family
ID=35424004
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/856,435 Abandoned US20050263421A1 (en) | 2004-05-28 | 2004-05-28 | Cassette with encoded lumen claim |
Country Status (3)
Country | Link |
---|---|
US (1) | US20050263421A1 (en) |
CN (1) | CN100574812C (en) |
ZA (1) | ZA200504313B (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050263422A1 (en) * | 2004-05-28 | 2005-12-01 | Kohler James P | Cassette assembly |
US20080267817A1 (en) * | 2007-04-30 | 2008-10-30 | Midmark Corporation | Water management system for sterilizer |
US20100163448A1 (en) * | 2008-12-30 | 2010-07-01 | Phygen, Inc., D/B/A Sterilucent, Inc. | Package for chemicals |
IT202000013114A1 (en) * | 2020-06-03 | 2021-12-03 | Steelco Spa | PORTABLE EQUIPMENT FOR SANITIZING ITEMS |
Families Citing this family (5)
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CN102490984A (en) * | 2011-12-20 | 2012-06-13 | 北京白象新技术有限公司 | Clip hydrogen peroxide capsules with radio frequency identification device (RFID) detection |
CN102526779A (en) * | 2012-03-01 | 2012-07-04 | 北京白象新技术有限公司 | Hydrogen peroxide injecting device of rotating disc type low-temperature plasma sterilizer |
CN103448930B (en) * | 2013-09-09 | 2015-09-23 | 山东新华医疗器械股份有限公司 | The preparation method of cartridge hydrogen peroxide capsule |
US10500297B2 (en) * | 2016-11-21 | 2019-12-10 | Asp Global Manufacturing Gmbh | Apparatus and method for detecting improper positioning of removable component of sterilizing system |
CN107469116A (en) * | 2017-09-15 | 2017-12-15 | 山东新华医疗器械股份有限公司 | A kind of formalin automatic filling system |
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---|---|---|---|---|
US20050263422A1 (en) * | 2004-05-28 | 2005-12-01 | Kohler James P | Cassette assembly |
US20080267817A1 (en) * | 2007-04-30 | 2008-10-30 | Midmark Corporation | Water management system for sterilizer |
US20080299003A1 (en) * | 2007-04-30 | 2008-12-04 | Midmark Corporation | Portable sterilizing apparatus for surgical and dental instruments |
US8236253B2 (en) | 2007-04-30 | 2012-08-07 | Midmark Corporation | Portable sterilizing apparatus for surgical and dental instruments |
US8252246B2 (en) | 2007-04-30 | 2012-08-28 | Midmark Corporation | Water management system for sterilizer |
US20100163448A1 (en) * | 2008-12-30 | 2010-07-01 | Phygen, Inc., D/B/A Sterilucent, Inc. | Package for chemicals |
US7993609B2 (en) | 2008-12-30 | 2011-08-09 | Sterilucent, Inc. | Package for chemicals |
IT202000013114A1 (en) * | 2020-06-03 | 2021-12-03 | Steelco Spa | PORTABLE EQUIPMENT FOR SANITIZING ITEMS |
EP3919086A3 (en) * | 2020-06-03 | 2022-03-09 | Steelco S.p.A. | Portable apparatus for sanitizing articles |
Also Published As
Publication number | Publication date |
---|---|
CN100574812C (en) | 2009-12-30 |
CN1701819A (en) | 2005-11-30 |
ZA200504313B (en) | 2007-02-28 |
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Legal Events
Date | Code | Title | Description |
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AS | Assignment |
Owner name: ETHICON, INC., NEW JERSEY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KOHLER, JAMES P.;REEL/FRAME:015762/0644 Effective date: 20040616 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- AFTER EXAMINER'S ANSWER OR BOARD OF APPEALS DECISION |