US20050263422A1 - Cassette assembly - Google Patents

Abstract

A cassette for a sterilizer has one or more cells containing a sterilant, is received within a sleeve and the sleeve 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 is a continuation-in-part of U.S. patent application Ser. No. 10/856,435 filed May 28, 2004, the contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
• This application relates to cassettes for delivering sterilant to an instrument sterilizer, and more particularly to such cassettes and their packaging.
• 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, California.
• 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 or a sleeve into which is received the 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.
SUMMARY OF THE INVENTION
• A cassette for a sterilizer according to the present invention comprises a body having one or more cells containing a quantity of liquid sterilant. The body is received within a sleeve and a bar code on the sleeve 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.
• The bar code in one aspect of the invention resides on a label attached to the sleeve. Alternatively, it is printed onto the sleeve.
• In a preferred embodiment, the cassette has a plurality of the cells.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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;
• FIG. 18 is a perspective view of the blank ofFIG. 17 folded to form the spent cassette collection box;
• FIG. 19 is a perspective view of a cassette according to the present invention having an outer sleeve;
• FIG. 20 is a side elevational view of a cassette handling system for processing the cassette and sleeve ofFIG. 19;
• FIG. 21 is a top plan view of a cassette according to the present invention received within a packaging system according to the present invention; and
• FIG. 22 is a top plan view of the cassette and packaging system ofFIG. 21 prior to final closure of the package.
DETAILED DESCRIPTIONSterilizer Overall Configuration
• FIG. 1 shows in block diagram form avapor phase sterilizer10 employing acassette handling system12 according to the present invention. Thesterilizer10 comprises avacuum chamber14 and avacuum pump16 for exhausting atmosphere therefrom. Avaporizer18 receives liquid sterilant from thecassette handling system12 and supplies it in vapor form to thevacuum chamber14. Ascreen grid electrode20 is provided within thevacuum chamber14 for exciting the contents into the plasma phase during a portion of the sterilization cycle. A micro filteredvent22 andvalve24 allow sterile air to enter thevacuum chamber14 and break the vacuum therein. Acontrol system28 ties in to all of the major components, sensors and the like within thesterilizer10 to control the sterilization cycle.
• A typical sterilization cycle might include drawing a vacuum upon thevacuum chamber14 and turning on power to theelectrode20 to evaporate and extract water from thevacuum chamber14. Theelectrode20 is then powered off and a low vacuum of less than1 torr drawn on thevacuum chamber14. Sterilant, such as hydrogen peroxide solution, is vaporized by thevaporizer18 and introduced into thevacuum chamber14 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 theelectrode20 and the sterilant is driven into the plasma phase. Theelectrodes20 are powered down and filtered air is drawn in through thevalve24. 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 to4, thecassette handling system12 according to the present invention is shown. It comprises in gross, acarriage32 for holding acassette34, alead screw36 andmotor38, anextractor subsystem40 and ascanner42.
• Thecarriage32 comprises abottom panel44, aside panel46 andtop panel48 along with smallvertical flanges50 and52 on the top and bottom andtop panels48 and44, respectively, to capture thecassette34. The bottom, side andtop panels44,46 and48 flare outwardly at anentrance54 of the carriage to aid in insertion of thecassette34. Two spring catches56 on theflanges50 and52 engage irregular surfaces of thecassette34 to firmly position thecassette34 within thecarriage32.
• Thecarriage32 travels along thelead screw36 and is supported on anupper rail58. Alead screw nut60 attached to thebottom panel44 and having a threadedopening62 and an unthreadedopening63 receives thelead screw36 and effects horizontal movement of thecarriage32 in response to rotations of thelead screw36.Flanges64 extend outwardly from thetop panel48 andflanges66 extend outwardly from theside panel46 each havingopenings69 for receiving theupper rail58. Themotor38 is preferable a stepping motor and connects to thelead screw36 to precisely control the horizontal position of thecassette34 relative to aframe68.
• Theextraction assembly40 comprises anupper needle70 and alower needle72, each being of a lumened configuration. The upper needle connects to anair pump74 which can force air out through theupper needle70. Thelower needle72 connects to avalve76 and from there is plumbed to thevaporizer18.
• Thescanner42 is oriented so as to be able to read abarcode80 on thecassette34 as well as abarcode82 on a spentcassette collection box84. Upon insertion of thecassette34 into thecarriage32 thescanner42 reads thecassette barcode80. Thebarcode80 is preferably encoded with information regarding the contents of thecassette34, including lot numbers and expiration dates. This information can be used to determine whether thecassette34 is fresh and of the correct type and whether thecassette34 has been used in the system before and thus is at least partially empty. The code is communicated to thecontrol system28 which makes these determinations.
• Thescanner42 can also see the spent cassettecollection box barcode82 when thecarriage32 moves inwardly and away from thescanner42. Each spentcassette collection box84 preferably has twobarcodes82, one in each opposing corner so that thescanner42 can see one of them regardless of which end of the spentcassette collection box84 is inserted first. With the spentcassette collection box84 filled, the spentcassettes34 block thebarcode82 which alerts thecontrol system28 that there is no capacity for receiving additional spentcassettes34. Preferably this message will be output to a user, such as on a display screen (not shown). If thecassette34 is empty it will not be ejected and no new cycles will be run until a spentcassette collection box84 having capacity to receive a spentcassette34 is placed into thesterilizer10.
• Aforward flag86 andrearward flag88 project outwardly and downwardly from thecarriage side panel46. They slide through aslot90 in aslot sensor92 which detects their presence within theslot90, such as by blocking a beam of light. Travel of thefront flag86 andrear flag88 through theslot sensor92 provides a reference location of thecarriage32 to thecontrol system28.
• Thetop panel48 of thecarriage32 can rotate about theupper rail58. Aspring94 between thetop panel48 andside panel46 biases thetop panel48 downwardly to hold thecassette34 within thecarriage32. A disposingcam96 sits behind theside panel46 and aligns with an ejectingtab98 which extends outwardly and downwardly from thetop panel48 and which can project through anopening100 in theside panel46 when thetop panel48 rotates upwardly. Such rotation of thetop panel48 releases its hold upon thecassette34 and due to the ejectingtab98 projecting through theopening100 pushes thecassette34 out of thecarriage32 and into the spent cassette collection box.
• The disposingcam96 controls rotation of thetop panel48. It comprises a generally triangular shape, having an outwardly facingside102, forwardly facingside104 and rearwardly facingside106. Turning also now toFIG. 5, it mounts for rotation upon an upwardly extendingspindle108. Aspring110 biases the disposingcam96 counterclockwise, urging the outwardly facingside102 into contact with anabutment112. Inward movements of thecarriage32 allow theejecting tab98 to cam over the rearwardly facingside106 of the disposingcam96, thus allowing the disposingcam96 to rotate clockwise and allow theejecting tab98 to pass thereby without effecting rotation of thetop panel48. However, outward movement of thecarriage32 causes the ejectingtab98 to cam over the forwardly facingside104 of the disposingcam96. During such motion contact between the outwardlyfacings side102 of the disposingcam96 and theabutment112 prevents rotation of the disposingcam96. The camming of the ejectingtab98 thus causes it to move laterally toward theside panel46 thereby rotating thetop panel48 upwardly and releasing thecassette34 from thecarriage32.
• Prior to inserting thecassette34 thecarriage32 is fully retracted to its outward position (to the left as shown inFIG. 5). In this position also, aforward end114 on thelead screw nut60 engages astop116 thus positively locating the position of thecarriage32. Turning also now toFIG. 6, manual insertion of thecassette34 causes thecarriage32 to move inwardly (to the right as shown inFIG. 6) and moves thefront flag86 into theslot sensor92. This movement is preferably caused by the physical force from inserting thecassette34, however, a torque or other sensor could be applied to allow the steppingmotor38 to take over this movement upon feeling the force of thecassette34 being inserted into thecarriage32. Allowing this movement to come from the force of the insertion of thecassette34 ensures that thecassette34 is fully seated within thecarriage32 before the movement begins.
• Once thefront flag86 is read by theslot sensor92 thestepper motor38 takes over and starts to move thecarriage32 inwardly. Turning also now toFIG. 7, during this stage, thescanner42 scans thebarcode80 on thecassette34. Thecontrol system28 interprets the information coming from thebarcode80 and determines whether thecassette34 has been used in thesterilizer10 before, whether the cassette contains fresh sterilant, and other data as appropriate. Preferably, the information on thebarcode80 is encrypted to prevent unauthorized parties from creating cassettes which may not meet the quality standards necessary for proper sterilization.
• If thecontrol system28 rejects the cassette34 acarriage32 is moved sufficiently inwardly so as to pass the ejectingtab98 past the disposingcam96 and is then moved back to the insertion position shown inFIG. 5 to eject the rejectedcassette34. If thecassette34 is accepted, thecarriage32 continues inward movement to the home position as shown inFIG. 8 in which therear flag88 has just passed out of theslot sensor92.
• Turning also now toFIGS. 9 and 10, thecassette34 comprises a plurality ofcells118 containingliquid sterilant120. Various structures of a cassette may be employed. Thecassette34 shown comprises a hardouter shell122, preferably formed of an injection molded polymer, such as high impact polystyrene, high density polyethylene or high density polypropylene, which encloses theindividual cells118, thecells118 being formed of a blow molded polymer such as low density polyethylene. However, a more rigid material can be used to form thecassette cells118 in which case theouter shell122 could be omitted. In thecassette34 shown, anupper aperture124 andlower aperture126 through theshell122 allows the upper andlower needles70 and72 to penetrate the shell. Thecell118 is formed of a material easily penetrated by the needles. If thecell118 is formed of a more substantial material, a thinning of the material could be provided at the locations to be penetrated by theneedles70 and72.
• Thecontrol system28 uses the home position ofFIG. 8 as a reference position for positioning thevarious cells118 in front of theextractor subsystem40. By moving the carriage32 a predetermined amount from the home position a givencell118 can be brought to face theextractor system40. InFIG. 9, cell one has been placed in front of theextractor system40. Turning also now toFIG. 11, anactuator128 drives theextractor subsystem40 toward thecassette34 causing the upper andlower needles70 and72 to penetrate the upper andlower apertures124 and126 and enter thecell118. After the needles have fully extended, theair pump74 drives air into thecell118 through theupper needle70. The system waits a couple of seconds before starting theair pump74 and opening thevalve76 to ensure proper placement and settling of the needles within thecell118. Thesterilant120 flows out through thelower needle72 and is piped off to thevaporizer18. After a sufficient time to extract thesterilant120, theair pump74 switches off and the actuator retracts theextractor subsystem40 from thecassette34.
• Thevaporizer18 connects to thevacuum chamber14 which allows thelower needle72 to easily be placed at a pressure below atmospheric. Thus, thepump74 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 thecell118.
• Rather than employ upper andlower needles70 and72, 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 thecell118 vertically, or substantially so, from an upper part of thecell118, preferably with such a double lumen needle. This would minimize leakage around the hole created by the needle entering thecell118. Such entry would also allow the tip of the needle to come closer to the lowest point of thecell118 for maximum extraction efficiency. If one desired to extract less than all of the contents of thecell118, one method would be to position the needle extracting the sterilant, such as thelower needle72 or the just mentioned double lumen needle, at the level in thecell118 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 toFIG. 12, each time thecontrol system28 determines that a new dose ofsterilant120 is required, thestepper motor38 moves the cassette to position thenext cell118 in front of theextractor subsystem40 and a new extraction takes place. Multiple extractions may be employed for a given sterilization cycle. When thecassette34 has been depleted, thecarriage32 moves towards the insert position thus causing the ejectingtab98 to cam over the disposingcam96 to rotate thetop panel48 upwardly and project the ejectingtab98 through theopening100 to drive thecassette34 out of thecarriage32 as described above and as shown inFIG. 13. Thecassette34 falls into the spentcassette collection box84 and thecarriage32 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 system12.
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 forinstance 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 isGeobacillus stearothermophilus.
• Rather than always run the sterilizer to achieve its maximum lumen claim, it may be desirable to run thesterilizer10 in different cycles depending upon the devices loaded therein for sterilization. Preferably, an operator selects a lumen claim when loading thesterilizer10 based upon the most challenging lumen device being loaded and then enters that lumen claim into thecontrol system28. Alternatively, the devices can be coded themselves, such as with a bar code which is scanned as the device is loaded, and thecontrol system28 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 cassettes34 having loads of sterilant optimized for a given lumen claim cycle are provided. Preferably, the lumen claim is encoded onto thebarcode80 along with other data such as the sterilizer model for which thecassette34 is intended and the expiration date.
• A suggested data layout for thebarcode80 comprises the following fields: a) sterilizer model for which thecassette34 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 thebarcode80, 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 × 1000mm	50% wt	2 g	15 minutes
  TEFLON*lumen
  1 mm × 125 mm,	59% wt	1.7g	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 × 400mm	90% wt	0.23 g	3 minutes
  Stainless Steel
  lumen
  1 mm × 150mm	90% wt	0.34 g	3 minutes
  Stainless Steel
  lumen
  1 mm × 500mm	90% wt	0.45 g	7 minutes
  Stainless Steel
  lumen
  1 mm × 350mm	90% wt	0.45 g	3 minutes
  TEFLON* lumen
  *polytetrafluoroethylene TEFLON is a trademark of 3M Co.

• Beyond merely entering lumen data, thecontrol system28 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 thesterilizer10 or via measuring plasma power.
• Thesterilizer10 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 thecassette34 and spentcassette box84 can be replaced with radio frequency identification tags, commonly known as RFID tags. AnRFID system130 is shown inFIG. 15. It comprises acontroller132 connected via anSPDT reed relay134 to acassette insertion antenna136 located on thecarriage32 and acassette disposal antenna138 located beneath thespend cassette box84. Eachcassette34 carries acassette RFID tag140. Similarly, each spentcassette collection box84 carries a collectionbox RFID tag142. Preferably, thecontroller132 comprises a Texas Instruments multifunction reader module S4100 and the RFID tags140 and42 comprise Texas Instruments RFID tag RI-101-112A each of which are available from Texas Instruments, Dallas, Tex.
• The control system28 (FIG. 1) selects one of the antennas, as for instance thecassette insertion antenna136 and sends a signal to therelay134 to engage this antenna with theRFID controller132. The antenna reads the information stored on the cassetteinsertion RFID tag140 which identifies thecassette34 and its contents. The information read is similar to the information read using the barcode, however preferably, theRFID tag140 has the ability to update the information stored thereon. Accordingly, additional data such as the filling status ofindividual cells118 within thecassette34 can be stored on the RFID tag. Thus, if thecassette34 is removed and then reinserted into thesterilizer10, or even intodifferent sterilizer10, thecontrol system28 can be apprised of the status of each of theindividual cells118 within thecassette34. This allows the reuse of a partially usedcassette34. Also, since theRFID tag140 can hold more data than thebarcode80, more data about thecassette34, its contents and manufacturing can be included thereon.
• The spentcollection box antenna138 reads the spent collectionbox RFID tag142 to determine the presence or absence of the spentcassette collection box84. Other data such as a unique identifier for thebox84, the capacity of thebox84, howmany cassettes34 are currently in thebox84 and how many of thecells118 therein are not empty can be included on theRFID tag142. Thecontrol system28 can track howmany cassettes34 have been ejected into the box to determine whether it has room for morespent cassettes34. Theantenna138 can also read the cassette RFID tags140 and count the number ofcassettes34 within thebox84. When thebox84 is full thecontrol system28 alerts the operator, as by a message on a screen. This message can also include information regarding thecassettes34 within thebox84. For instance if not all of thecassettes34 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 thecassette34. Radio frequency energy sent by theantennas136 and138 induce sufficient current within the antenna inside the RFID tags140 and142 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 tags140 and142. 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 thesterilizer10 and the like.
• Some sterilants are affected by heat. TheRFID tag140 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 thecassette34 can be rejected by thecontrol system28. Temperature measuring RFID tags are available from KSW-Microtec, Dreseden, Germany and from Identec Solutions, Inc., Kelowna, British Columbia, Canada. The interior of thesterilizer10 where thecassette34 sits may be higher than ambient temperature. Thus, it may be beneficial to put a maximum residence time (on board shelf life) on thetag140 or even to update on thetag140 this time the cassette has already spent inside of the sterilizer.
• To test sterilant measuring equipment in thesterilizer10, it may be beneficial to providecassettes34 having water or other fluids within one ormore cells118. Information regarding the special nature of thecassette34 and its contents could be written onto the RFID tag.
• During a cycle the sterilizer may only require part of the contents of acell118. For instance, a particular cycle may call for the contents of one and a half cells. The half filled nature of thecell118 can be stored and then for the next cycle thatcell118 can be drained.
• Preferably, communications between thetag140 and142 and thecontroller132 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 controller132 reads the data and the algorithm in thecontrol system28 decrypts the data to reveal the stored information.
• Other methods could be used to communicate between thecassette34 and thesterilizer10. For instance information could be stored magnetically on thecassette34, 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 thecassette34 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, thesterilizer10 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 thecassettes34. Poorly performingcassettes34 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 ofcassettes34 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 toFIGS. 17 and 18, the spentcassette collection box84 is preferably folded from a single sheet of printed cardboard or other stock.FIG. 17 shows an unfolded blank150 andFIG. 18 shows the blank150 folded to form the spentcassette collection box84.
• The blank150 is divided by a series of fold lines (shown dashed) and cut lines into abottom panel152,side panels154,end panels156 andtop flaps158. Foldingtabs160 extend laterally from theside panels154. Additionalfolding tabs162 extend laterally from theend panels156.Barcodes82 are printed on theside panels154 in a position to be visible in an upper interior corner of the spentcassette collection box84 when it is folded into the configuration shown inFIG. 18. A pair of topflap locking tabs164 extend from thetop flaps158 and fit intoslots166 in the opposingtop flap158 when thebox84 is closed and intoslots168 at the intersection of thebottom panel152 andside panel154 when thebox84 is opened.
• To fold the box, thefolding tabs160 on theside panels154 are folded upwardly and then theside panels154 are folded upwardly, thereby aligning thefolding tabs160 with the intersection between thebottom panel152 and theend panels156. Theend panels156 are then folded upwardly and the endpanel folding tabs162 are folded downwardly over thefolding tabs160. Lockingtabs170 on the endpanel folding tabs162 fit intoslots172 at the intersection between thebottom panel152 and endpanels156.
• To place thebox84 into the open position as shown inFIG. 18, thetop flaps158 are folded downwardly to the outside and the lockingtabs164 fitted into theslots168. Once thebox84 is filled with spent cassettes, thetop flaps158 are folded upwardly over the top and the lockingtabs164 can then be fitted into theslots166 on the opposing top flaps158. This unique folding arrangement allows spentcassettes34 to fall into theopen box84 easily without thetop flaps158 getting in the way and also allows easy closure of thebox84 once it has become filled.
• FIG. 19 shows acassette200, similar to thecassette34. However, thecassette200 fits within anouter sleeve20 which protects thecassette200 and which is preferably absorptive of the liquid sterilant such that any droplets thereof which might remain on thecassette200 after a sterilization cycle would be absorbed by thesleeve202 thereby preventing user contact with the sterilant.FIG. 20 shows thecassette200 within an alternatecassette handling system204.
• In thissystem204 thecassette200 andsleeve202 enter through an opening205.Rollers207 move thecassette200 andsleeve202 into thesystem204 where abar code206 on aflap208 is read by abar code reader210 through awindow211 through thesleeve202 and the information passed to acontrol system212. Thecontrol system212 checks that aproper cassette200 has been inserted into thesystem204 and then signals therollers207 to extract thecassette200 from thesleeve202. Preferably, thebar code206 is encoded with a lumen claim as previously discussed.
• When thecassette200 returns to thesleeve202 theflap208 is pushed out of the way so that it will not be read if thecassette200 andsleeve202 are reinserted into thesystem204, thereby preventing use of a spentcassette200. Of course, rather than employ theflap208 the bar code can be printed on thesleeve202 without a flap, or on thecassette200 and be visible through thewindow211. In this case the previously discussed methods for ensuring that the cassette has not been used are preferably employed.
Packaging for the Cassette
• FIG. 21 illustrates apackaging system300 for acassette302 similar to thecassette34. Thecassette302 is received within a clear, liquid impermeableouter wrap304. Alabel306 andbar code308 are visible through thewrap304. An RFID or other tag could substitute for or compliment thebar code308. Thewrap304 is preferably formed of clear oriented polypropylene. Anabsorbent web310 attached to the inside of thewrap304 encircles thecassette302 about the portion which contains the hydrogen peroxide. Theabsorbent web310 is preferably formed of a non-woven matrix of melt blown polypropylene impregnated with a superabsorbent polymer. For the purposes of the present invention, the term “superabsorbent polymer” refers to materials which are capable of absorbing and retaining at least about 30 times their weight in the liquid sterilant of thecassette302 under a 0.5 psig pressure. Suitable super absorbent polymers include polyacrylamides and polyacrylates, and in particular crosslinked sodium polyacrylate. One suitable superabsorbent web is Korma HY0301038 available from BPA Fiberweb of Nashville, Tenn.
• The packaging system is preferably formed by attaching, as for instance by adhesive bonding, theabsorbent web310 to asheet312 of clear polypropylene and thecassette302 positioned thereon (seeFIG. 22). Thesheet312 andweb310 are wrapped around thecassette302 and edges thereof attached to form aseal314.
• Theabsorbent web310 is preferably fire resistant and preferably forms no hazardous reactions with the sterilant. The amount of superabsorbent polymer is preferably sufficient to absorb all of the sterilant within the cassette and retain it without release even under externally applied pressure of2 or3 pounds per square inch. A sleeve as in the previous embodiment can be employed, but is preferably formed of a material which also is fire resistant and forms no hazardous reactions with the sterilant. A color change indicator showing the presence of sterilant is present within theouter wrap304 and visible therethrough to warn a user not to open the wrap if sterilant has leaked out of thecassette302. When using a sterilant in solution with water, the indicator can indicate the presence of the water, such as the ULTRA THIN WATER CONTACT INDICATOR TAPE 5559 available from 3M.
• 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 assembly for a sterilizer, the cassette assembly comprising:

a body having one or more cells, at least one of the one or more cells containing a quantity of liquid sterilant;

a sleeve receiving the body; and

a bar code on the sleeve, the bar code having encoded therein a lumen claim.

2. A cassette assembly according toclaim 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 assembly according toclaim 1 wherein the sterilant comprises hydrogen peroxide solution.

4. A cassette assembly according toclaim 1 wherein the lumen claim specifies a length and internal diameter of a lumen.

5. A cassette assembly according toclaim 4 wherein the lumen claim specifies a material from which the lumen is constructed.

6. A cassette assembly according toclaim 1 wherein the bar code has encoded therein a length and an internal diameter for the lumen claim.

7. A cassette assembly according toclaim 6 wherein the bar code has encoded therein a material for the lumen claim.

8. A cassette assembly according toclaim 1 wherein the bar code is on a label attached to the sleeve.

9. A cassette assembly according toclaim 1 wherein the bar code is printed on the sleeve.

10. A cassette assembly according toclaim 1 comprising a plurality of the cells.

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