MXPA96003651A - Cutter to open reactive drapsesterilizan - Google Patents

Abstract

The present invention relates to a decontamination system comprising: a body portion including a water receiving inlet, a drain outlet, a decontamination region for receiving articles to be decontaminated, and a well receiving a cup of reagent, a means for defining fluid flow paths between the inlet, the reagent cup receiving well, the decontamination region, and a rinsing fluid source, a fluid circulation means for circulating fluid selectively through the fluid flow paths and between the outlet, the heating medium, the rinsing fluid source, the decontamination region, and the reagent cup receiving well, and a cutting blade assembly disposed in the well Reagent cup receiver, the cutting assembly comprising: a central arrow extending vertically upwards from the base of the well, the arrow defining an interior passage hollow and receiving fluid flow from the fluid circulation system, the arrow further having at least two openings communicating between the hollow interior passage and the outside of the arrow, to direct fluid flow to a received reagent cup; cutting blade mounted on the central arrow and having a tip for piercing a bottom of the received reagent cup, the cutting blade being divided by the central arrow to form two sheet sections on opposite sides of the central arrow; a cutting edge for cutting the received reagent cup and a curvilinear configuration for camming the reagent cup and diverting the fluid flow to the cup to activate the complete washing of the reagent cup reagents

Description

"CUTTER TO OPEN STERILIZING REACTIVE VESSELS" BACKGROUND OF THE INVENTION The present invention relates to the decontamination branch. Find specific application together with the sterilization or disinfection of medical instruments and equipment, dentistry, veterinary, mortuary and laboratory and will be described with specific reference to them. It will be appreciated, however, that the invention is also applicable to a wide variety of technologies where reagents are mechanically released at the time of use. Decontamination represents the removal of hazardous or unwanted materials such as bacteria, mold spores, other pathogenic life forms, radioactive fine dust and the like. Disinfection represents the absence of pathogenic or harmful life forms. Sterilization represents the absence of all forms of life, whether pathogenic or not. Frequently, the esterization is measured against the elimination of bacterial endospores which are the living organisms most resistant to conventional sterilants. Microbial decontamination is used herein as the generic term for both sterilization and disinfection. Until now, medical, dental, surgical, veterinary and laboratory equipment has frequently been sterilized in a steam autoclave. Autoclaves kill life forms with a combination of high temperature and pressure. However, steam autoclaves have several inconveniences. The containers of high temperature and pressure tend to be bulky and heavy. The high temperature and pressure tends to reduce the useful life of endoscopes, rubber and plastic devices, lenses, bearings and portions of devices made of polymeric materials and the like. In addition, autoclaving the cooling cycle is long enough, so that multiple sets of medical instruments are commonly required. Instruments that can not withstand the pressure or temperature of the furnace autoclave are often sterilized with ethylene oxide gas, particularly in larger medical facilities or hospitals. However, the sterilization technique with ethylene oxide also has several inconveniences. First, the sterilization site with ethylene oxide is even longer than the steam autoclave cycle. Another inconvenience is that sterilization with ethylene oxide is sufficiently sophisticated so that trained technicians are commonly required making this inappropriate for a doctor and dental offices or for other smaller medical facilities. Still another inconvenience is that certain medical equipment can not be sterilized with ethylene oxide gas. Liquid sterilization systems have also been used for equipment that can not withstand the high temperatures of steam sterilization. Commonly, a technician mixes a liquid sterilizing composition and manually semises the articles to be sterilized. The high degree of manual labor introduces numerous uncontrolled and undisclosed variables in the sterilization process. There are quality safety problems with the weakening of the sterilizers due to shelf aging, technical error in the mixing of sterilants, technical error in the control of the immersion times, technical error between the immersion and the rinsing of the waste, error technician in the exposure to the ambient atmosphere after the rinsing step and the like. Another problem with the liquid system of the prior art lies in the corrosive nature of the concentrated oxidants that are commonly used as liquid sterilants. Normally, the sterilized items are rinsed to remove the chemical reagents. This rinse also adds a varible that reduces the assurance that the item has been disinfected or sterilized. Once it has been rinsed, the article is susceptible to reinfection by microbes carried in the waters. In US Patent Number 5,209,909, which is also from the concessionaire hereof, a reactive system using only powdered reagents was described. The powdered reagents were stored in separate compartments in a two compartment cup. The two compartment cup was cut open with knife blades and the two reagents were dissolved in high pressure water. The dissolved reagents reacted to form a sterilizing solution with stabilizers, corrosion inhibitors, a wetting agent and the like. All the powdered formulation has certain notable advantages in relation to the liquid peracetic acid system. Several restrictions by aerial lines effectively limit the shipment of liquid peracetic acid for surface transport. Because liquid peracetic acid has a limited shelf life through which full potency can be ensured, accurate timing is required to ship liquid peracetic acid sterilizing systems to overseas and have them arrive for a duration of shelf remaining satisfactory. The present invention provides a new and improved cutter assembly that is ideal for opening the spray reagent packages.

SUMMARY OF THE INVENTION In accordance with the present invention, a cutter blade assembly is provided to open by cutting a package containing the reagent. A central arrow defines a hollow interior passage to receive fluid flow from a fluid circulation system. The arrow has at least two openings that communicate between the hollow interior passage and the exterior of the arrow to direct the flow of fluid to the reagent package. A cutting blade that is mounted on the central arrow has an apex to pierce a lower portion of the reagent package. The cutting blade is divided by the central arrow to form two opposite but analogous sheet sections on the opposite sides of the central arrow. Each blade section has a cutting edge and a curvilinear configuration to divert the flow of fluid to the reagent package in order to activate the complete mixing of the reagent and the fluid. In accordance with a more limited aspect of the present invention, the curvilinear configuration of each leaf section defines cam surfaces that engage and separate the cut edges of the reagent pack. In accordance with another aspect of the present invention, a method for opening a frangible package is provided. The frangible package, having a base wall and a peripheral wall, is inserted into the base wall first into the receiving well of the package. As the package is received, the base wall is pierced in a center with an apex portion of a cutting blade. With continued insertion of the package into the well, the cutting blade cuts deeper into the base wall and cuts toward the peripheral walls. With additional continuous insertion of the package into the well, the portions of the base and peripheral walls were placed in cam separate ones adjacent to the cuts made by the cutting blade. In accordance with a more limited aspect of the present invention, the package contains at least one dry reagent therein. The dry reagents are washed from the inside of the package by spraying water jets from a central arrow of the cutting blade and by diverting at least part of the jets with the cutting blade to increase the turbulence. An advantage of the present invention is that it opens the reagent packet in such a manner that all dry reagents are completely dissolved. Another advantage of the present invention is that it facilitates the flow of fluid in and out of the interior of the reagent pack. Still further advantages of the present invention will become apparent to those skilled in the art upon reading and understanding the following detailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS The invention can take a form in various components and arrangements of components and in several steps and arrangement of steps. The drawings are only for the purpose of illustrating a preferred embodiment and should not be construed as limiting the invention. FIGURE 1 is a perspective view of a decontamination unit to be placed on the top of the counter; FIGURE 2 is a front view of the decontamination unit of FIGURE 1, with the front door open; FIGURE 3 is a diagram of the sanitary installations of the antimicrobial solution that carries trajectories of the decontamination unit of the FIGURE 1; FIGURE 4 is a top view of the cutter assembly of FIGURES 2 and 3; FIGURE 5 is a side view of the cutter assembly; FIGURE 6 is a front elevational view of the cutter assembly; and FIGURE 7 is a sectional view of a reactive cup or package.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY Referring to FIGS. 1 and 2, a sterilization apparatus A is configured to settle on an upper part of the counter or other convenient work surface. A front door B is capable of being manually opened to provide access to insert a cartridge C and a sterilizing cup or vial D into the system. During the insertion of the cup or vial D, the lower part of the cup or vial is pierced by an apex of an E cutter assembly. The articles to be sterilized are loaded into the cartridge C which is slidably received in a chamber 10 receiving sterilization cartridge for decontamination. The chamber 10 is open at the front to receive a free flow of the sterilant through the front. Referring specifically to FIGURES 2 and 3, the water from an inlet 12 is selectively heated in a heating tank 14 and circulated by a circulation pump 16 to a sterilant or other microbial decontamination solution mixing chamber 20. The mixing chamber 20 receives the cup D containing a pre-measured dose of a microbial decontamination concentrate, preferably in pulverized form. The water is sprayed into the cup or vial D through the cutter assembly E, as will be discussed below, for a sterilant or other antimicrobial solution. After the circulating pump 16 circulates the heated water through the mixing chamber 20, the antimicrobial solution flows through a series of passages 22 defined in part by the outer face of the housing A, and the inner face of the the door B. The passages carry the antimicrobial solution over an internal surface of a flushing fluid sterilization filter 24 into the sterilization or decontamination chamber 10. The antimicrobial solution is circulated through the flow passages such that each surface of the rinse water filter 24 downstream through the passages and decontamination chamber 10 in a microbial manner and preferably is sterilized. After a pre-selected direction, the solution leaves the apparatus in a drain 26 and rinse water is introduced. The rinse water flows into the filter 24 which filters at least all of the harmful microbes from the inlet water, i.e., at least disinfects the rinse water. The circulation pump 16 circulates the decontaminated rinse water microbially through the paths 22, the decontamination chamber 10 and the cassette or cartridge C. In order to avoid contamination of the microbes carried by the waters, a filter 28 decontamination of air microbes filters the air that is drawn into the system to replace the dewatered rinse and antimicrobial solutions. With continued reference to FIGURES 2 and 3, and specific reference to FIGURES 4, 5 and 6, the antimicrobial mixing chamber 20 retains the cutter assembly E or selectively opens the cup D containing the reagent as it is inserted into the 20 antimicrobial mixing chamber and the door sometimes closes to be used or to start sterilization. The cutter assembly E includes a central arrow 30 or shaft extending upwards along the central axis of the wall of the mixing chamber 20. The arrow defines a hollow interior passage 32 in fluid communication with the circulation pump 16. Positioned along the axis of the arrow 30, there are two upper openings 34a directing the water jets upwardly towards the interior of the cup D. A pair of intermediate openings 34b are placed on the opposite sides of the arrow 30 to direct the water jets transversely. A lower pair of openings 34c directs the water radially outwardly into the cup. Of course, the number of openings 34 and the placement of the same on the arrow can be varied to suit larger or smaller units. In addition, the openings can be defined by round holes, slots or other appropriate configurations. The openings 34a, 34b and 34c communicate between the hollow passageway 32 within the arrow 30 and the interior of the reagent cup D. The fluid under pressure that is discharged through these openings washes and dissolves the powdered reagents retained in the cup D. It will be understood by a person skilled in the art that depending on the size and power of the cups and the unit, a larger or smaller number of openings can be provided. Now, attached to the arrow 30, there is a blade or a cutter means 40 that rests or sits across the horizontal flat top surface of the arrow 30. The blade 40 has an apex portion 42 that extends above the arrow 30. The apex portion 42 pierces the lower dome of the reagent cup D during the insertion of the cup into the chamber 20. The sheet 40 has two similar side sections 44 positioned on either side of the downwardly extending arrow. below the 42nd portion of the apex. The cutting edges 46 are inclined in opposite directions away from the apex portion downwardly along the side sheet sections 44 terminating adjacent a lower part of the chamber 20. The cutting edges 46 are bevelled to be oriented in opposite directions to assist to pierce and cut the cup D of reagent. The beveled cutting edges 42 each form an angle towards the front face of a corresponding side section of the sheet and extend through the entire length of the sheet, from the apex, to the bottom thereof. The blade 40 has a curvilinear configuration that defines a top cam surface 50 and an opposing bottom cam surface 52. The upper cam surface 50 projects outwards in the same direction as on the beveled face of the cutting edge. The cam surface engages a cut edge of the cup just after being cut by the cutting edge 46. The lower cam surface 52 projects opposite the upper cam surface. The lower cam surface engages an opposite cut edge of the cup. Together, the upper and lower cam surfaces keep the cut portions of the cup open. The curvilinear blade configuration sweeps around the intermediate openings 34b and the lower openings 34c. The lower surfaces of the cams deflect the jets of water from the openings and the turbulent water in the chamber 20 to improve the flow of water and complete the washing of all the reagents from the cup. Referring to FIGURE 7, the reagent cup D includes a first or outer cup 60 that holds a first reagent sprayed. The external cup 60 includes a cylindrical peripheral wall 62 having a flange 64 at a first open end thereof. A dome-shaped base wall 66 closes a second opposite end of the peripheral wall. The outer cup is constructed of a lightweight polymeric material, such as a styrene plastic having sufficient resilience so that the domed base wall 66 functions as a spring. A second cup portion 70 or internal portion 70 is received in the first cup portion 60. The second cup portion has a generally conical peripheral wall 72 having a flange 74 integrally molded into the first open end thereof. A base wall 76 closes a second end of the peripheral wall. The inner cup retains a first pulverized reagent. The first and second cup portions configure such that when the flanges 64, 74 are bumping and sealing together, the base walls 66, 76 bump and flex the dome 66 slightly. The second peripheral wall 72 has a recessed groove 78 extending longitudinally therealong to define access for filling an annular external compartment 80 that is defined between the peripheral wall 72 of the inner cup and the peripheral wall 62 of the cup. external with a second pulverized reagent. When the cutter assembly E enters the cup from the bottom, there is a tendency for one or both of the cups to be crushed under the force of the cutting blade instead of being cut. The peripheral wall 72 of the conical internal cup interacts with the peripheral wall 62 of the external cup to provide increased structural rigidity against vertical compression. A closure 82 is adhered to the flange 74 to seal the two chambers simultaneously. During use, as the reagent cup D is pressed down to the cutting blade 40, the base wall 62 engages the apex portion 42 of the sheet. An additional pressure causes the cutting edges 46 to recess from the piercing point through the lower wall 62 and the inner and outer peripheral walls 62, 72. With continuous pressure, the side portion 44 of the blade cuts through the peripheral walls 52, 62 of the inner and outer cup. The cam surfaces 50, 52 of the blade 40 cam the edges of the peripheral walls of the cup to open them extending the cut to a greater height. After the door B is closed and a decontamination cycle is started, the hot water is pumped to the arrow 30. The water is sprayed through the upper jets or openings 34a and sprayed towards the upper part of the inner cup . Spraying water through the central and lower jets or openings 34b and 34c, is sprayed towards the central and lower regions of both compartments. The serpentine configuration of the sheets 40 serves to deflect the fluid spray to further ensure total removal of all reactive materials from both chambers of the cup D. Various antimicrobial agents can be used. In the preferred embodiment, the antimicrobial agent is a mixture of powders that reacts when wet to form a sterilant, such as a concentrated oxidant, corrosion inhibitors and a wetting agent. More specifically to the preferred embodiment, the dry ingredients include a water-soluble acid precursor and a water-soluble persalt which, when dissolved in water, form a peracetic acid solution with an antimicrobially effective concentration of the peracetic acid. The dry ingredients further include a stabilizing agent eg, a borate, to bring the pH to a neutral level in order to inhibit the corrosion of the steel. The dry ingredients include other corrosion inhibitors, such as a molybdate to inhibit steel corrosion, a triazole to inhibit corrosion of copper and brass, and the like. Powdered wetting and sequestering agents may also be included. In the preferred embodiment, the acid precursor is acetylsalicylic acid and the persalt is sodium perborate. The total volume of the dry ingredients is such that the resulting water solution has a peracetic acid concentration of at least 0.2 weight percent / volume of a biocidally effective concentration. Other oxidizing or antimicrobial agents, such as chlorine dioxide, chlorine, hydrogen peroxide and mixtures thereof, may also be generated in situ. For example, the powdered ingredients may include a mixture of potassium chromates, sodium chloride and phosphates. As another example, hydrogen peroxide can be generated from a mixture of sodium borate and phosphates. Chlorine dioxide can be generated from a mixture of sodium chlorate and lithium chlorite. Sodium chloride can be added to the paracetic acid to produce the hyperchlorous acid. Other corrosion inhibitors for copper and brass are also proposed, such as benzotriazoles, polythriazoles, mercaptobenzothiozole, azoles, benzoates and other five-membered ring compounds. Other anti-corrosives include chromates, dichromates, tungstates, vanidates, borates and combinations thereof. A suitable sequestering agent to sequester any precipitated calcium and magnesia salts is sodium hexametaphosphate.

Claims (10)

- lí R E I V I N D I C A C I O N S

1. A cutting blade assembly (E) for opening by cutting a package containing the reagent (D), the cutting blade assembly comprises: a central arrow (30) defining a hollow interior passage (32) to receive the fluid flow from a fluid circulation system, the arrow further has at least two openings (34) communicating between the hollow interior passage of the arrow and the outside of the arrow to direct the flow of fluid to the package containing the reagent; a cutting blade (40) mounted on the central arrow and having an apex (42) for piercing a lower portion (66) of the reagent package, the cutting blade is divided by the central arrow to form two sheet sections (44) opposite but similar on opposite sides of the central arrow; each blade section has a cutting edge (46) and a curvilinear configuration for diverting the flow of fluid to the package containing the reagent in order to activate the complete mixing of the reagent and the fluid. The blade assembly according to claim 1, wherein the curvilinear configuration of each blade section defines an upper cam surface (50) projecting to one side of the central shaft and a cam surface (52). bottom projecting to an opposite side of the central arrow whereby the camming surfaces engage and separate the cut edges of the reagent package. The sheet assembly according to claim 2, wherein the central arrow has: upper openings (34a) on the opposite sides of the apex of the cutting blade; central openings (34b) in a central portion of the central arrow adjacent the upper cam surface such that the fluid directed therefrom is diverted towards the reagent package; and lower openings (34c) in a lower portion of the central arrow adjacent the lower cam surface such that fluid directed therefrom is diverted toward the reagent package. The sheet assembly according to claim 1 wherein the upper part of the central arrow has openings (34a) of the upper part defining upward directed jets and lower openings (34c) in the lower portion thereof. The sheet assembly according to claim 4, wherein the lower openings are placed on the opposite sides of the central arrow and are directed parallel to the sheet sections. The sheet assembly according to claim 1, wherein the cutting threads of the respective sheet sections are bevelled with bevels that are oriented in opposite directions. The sheet assembly according to claim 1 wherein the reagent pack retains a first sprayed component and a second component, the first and second sprayed components react in the fluid to form an oxidant. 8. A method for opening a frangible package comprising: inserting the frangible package (D) having a base wall (66) and a peripheral wall (62), the base wall first toward a well (20) receiving the package; as the package is received, pierce the base wall in the center thereof with an apex portion (42) of a cutting blade (40); with continuous insertion of the package into the well, cut deeper into the base wall and cut towards the peripheral walls with sharp cutting edges (46) of the cutting blade; with continuous insertion of the package into the well, place on cam (50, 52) the separated portions of the base and peripheral walls adjacent to the cuts made by the cutting blade. The method according to claim 9, wherein the package contains a dry reagent in an interior thereof and further includes washing the dry reagent from the interior of the package by spraying water jets from a central arrow of the cutting blade and diverting at least part of the jets with the cutting blade to increase the turbulence. The method according to claim 9, wherein the package has concentric inner (72) and outer (62) peripheral walls defining an internal compartment (70) and a compartment (80) External annular, one of the compartments contains a pulverized acid precursor and the other contains a powdered persalt and further includes: reacting the acid precursor and the persal in situ in the water to form an oxidizing solution.