Patent Application
20070092398
The present invention relates generally to a gas permeable pouch which may be used in sterilization procedures, as well as other uses. In addition, the present invention relates to a method of sterilizing an item used in a medical procedure.
Sterilization of items used in medical procedures is vital to minimizing the spread of harmful and infectious agents to patients. Typically, the items used in medical procedures are placed into a sterilization container such as sterilization wraps, vented rigid containers or into breathable pouches. Breathable pouches are packaging for items used in medical procedures which generally have a gas permeable material joined to a gas impermeable material. All of these containers are generally gas permeable. These sterilization containers preserve sterility of the items contained therein, as well as the interior portion of these containers, after the containers and contents of the container have been through a sterilization procedure. The gas permeable material allows a gas sterilant to enter the breathable pouch, rigid container or wrap, thereby allowing the gas sterilant to contact the item to be sterilized in the pouch, container or wrap.
In gas sterilization procedures, the wraps, vented rigid containers or breathable pouches, along with an item to be sterilized that are placed within the wraps, vented rigid containers and breathable pouches are placed into a sterilization chamber. Examples of current gas sterilization procedures include, gas plasma sterilization, steam sterilization, ethylene oxide sterilization, hydrogen peroxide sterilization, and ozone sterilization. Other sterilization procedures, such as irradiation have also been used.
When gas sterilization procedures are used to sterilize items used in a medical procedure, it is necessary for the gas sterilant to penetrate sterilization container to contact the item used in a medical procedure. As a result, in the case of breathable pouches or wraps, a portion of the pouch or wrap must be gas permeable. Current sterilization pouches have been made with a variety of configurations. For example, the entire pouch material may be gas permeable or portions of the pouch, such as side seams, are made of a gas permeable material. In the case where the side seams are prepared from a gas permeable material, the front and back panels are typically prepared from a gas impermeable material. Sterilization pouches with one or more of the side seams being prepared from a gas permeable material are generally stored flat and are partially or completely opened to create a three-dimensional space capable of accommodating an item to be sterilize within the three-dimensional space. Once the item is placed within the pouch, the pouch is close or otherwise sealed. When these pouches and the items contained within each pouch are sterilized, the pouches frequently stacked on top of one another or are adjacent one another. It is possible that the side seams may become compressed or otherwise occluded during sterilization such that the gas impermeable materials of the front and back panels potentially come into contact with one another, resulting in the gas permeability of the pouch being greatly reduced, if not eliminated. When this occurs, there is a potential that the items to be sterilized may not be completely sterilized.
In addition, the current pouches with the gas permeable side seams are difficult to stack in a sterilization chamber. Often as the pouches are stacked, the stacks tend to be unstable and have the potential to fall over. This can result in extra time being needed to sterilize the items in need of sterilization, requiring careful stacking of the sterilization pouches, such that the pouches have the gas permeable materials of the pouches remaining unblocked by any of the impermeable materials used in the pouches, while keeping the stacks from falling over. This task can be time consuming and tedious.
There is a need in the art for a sterilization pouch which can be used to sterilize items used in medical procedures that can ensure proper sterilization and can easily be placed in a sterilization unit, without the problems of the prior pouches.
Generally stated, the present invention provides a gas permeable pouch which has various uses including as a sterilization pouch for items in need of sterilization. The pouch has a front panel and a back panel, each panel having a top edge, a bottom edge, two side edges, a top margin at or near the top edge, a bottom margin at or near the bottom edge and two side margins at or near the two side edges wherein the top margin of the front panel is directly or indirectly joined to the top margin of the back panel and each side margin of the front panel is directly or indirectly joined to one of the side margins of the back panel. The pouch further has a bottom panel having a perimeter with a perimeter margin. This bottom panel is directly or indirectly joined at the perimeter margin to the bottom margins of the front side panel and back side panels using a line of juncture such that the bottom edge of the front panel and the bottom edge of the back panel are non-linear when the bottom panel is fully expanded. The front panel, back panel and bottom panel define a compartment capable of holding one or more articles. At least one of the front panel, the back panel or the bottom panel has a portion containing a gas permeable material. This gas permeable material allows gas to pass through the material and contact the one or more articles contained within the compartment or allows gas to pass through the gas permeable material from the inside of the compartment to the outside of the container.
In another embodiment of the present invention, the present invention provides a sterilization container for an item used in a medical procedure. The sterilization container allows an item used in a medical procedure to be sterilized prior to use in a medical procedure. The sterilization container has a front panel and a back panel, each panel having a top edge, a bottom edge, two side edges, a top margin at or near the top edge, a bottom margin at or near the bottom edge and two side margins at or near the two side edges wherein the top margin of the front panel is directly or indirectly joined to the top margin of the back panel and each side margin of the front panel is directly or indirectly joined to the one of the side margins of the back panel. The sterilization container further has a bottom panel having a perimeter with a perimeter margin. The bottom panel is directly or indirectly joined at the perimeter margin to the bottom margins of the front panel and back panel using a line of juncture such that the bottom edge of the front panel and the bottom edge of the back panel are non-linear when the bottom panel is fully expanded. The front panel, back panel and bottom panel define a compartment capable of holding one or more items used in a medical procedure. Contained within the compartment is an item used in a medical procedure which is in need of sterilization. At least one of the front panel, the back panel or the bottom panel has a portion containing a gas permeable material.
In another embodiment of the present invention, provided is a method for sterilizing an item used in a medical procedure. In this method, an item used in a medical procedure contained within a sterilization container is provided. The sterilization container has a front panel and a back panel, each panel having a top edge, a bottom edge, two side edges, a top margin at or near the top edge, a bottom margin at or near the bottom edge and two side margins at or near the two side edges wherein the top margin of the front panel is directly or indirectly joined to the top margin of the back panel and each side margin of the front panel is directly or indirectly joined to the one of the side margins of the back panel. The pouch further has a bottom panel having a perimeter with a perimeter margin. This bottom panel is directly or indirectly joined at the perimeter margin to the bottom margins of the front panel and back panels using a line of juncture such that the bottom edge of the front panel and the bottom edge of the back panel are non-linear when the bottom panel is fully expanded. The front panel, back panel and bottom panel define a compartment capable of holding one or more items used in a medical procedure. At least one of the front panel, the back panel or the bottom panel has a portion containing a gas permeable material. The sterilization container, with the item used in medical procedure contained within the compartment of the container, is exposed to a sterilization gas. In a further embodiment of this method of the invention, the sterilization container and medical item to be sterilized are placed into a sterilization chamber.
It should be noted that, when employed in the present disclosure, the terms “comprises”, “comprising” and other derivatives from the root term “comprise” are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, and are not intended to preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof.
As used herein, the term “self-supporting” means that the pouch has the property to stand upright and support the weight of the pouch. In addition, as used herein, self-supporting is also intended to indicate that the pouch of the present invention may also support the weight of the pouch and any items contained within the compartment of the pouch.
As used herein, the term “sterilization” refers to a wide variety of techniques employed to attenuate, kill or eliminate harmful or infectious agents. Examples of sterilization procedures include, for example, gas plasma sterilization, steam sterilization, ozone sterilization, hydrogen peroxide sterilization, ethylene oxide sterilization and irradiation.
The term “sterilizing conditions” refers to a combination of a concentration of sterilant and a time exposure interval which will sterilize an object which is subjected to a sterilant within a sterilizing container. Sterilizing conditions may be provided by a wide range of sterilant concentrations in combination with various time intervals. In general, the higher the concentration of a sterilant, the shorter a corresponding time interval is needed to establish sterilizing conditions. Accordingly, the effective amount of a sterilant may vary depending upon the length of exposure of the medical supplies to the sterilant.
As used herein, the term “gas permeable” is intended to mean a material which will allow gas to pass through the material but fails to allow airborne microbes, bacteria, viruses and mixtures thereof to pass through the material. Gas permeable materials are also referred to in the art as breathable materials.
As used herein, “gas impermeable” is intended to mean a material which does not readily allow gas to pass through the material. In addition, the gas impermeable material also fails to allow airborne microbes, bacteria, viruses and mixtures thereof to pass through the material.
As used herein, the term “opening device” refers to a mechanism which facilitates the opening of the pouch or container by a user.
As used herein, the term “closing device” refers to a mechanism which facilitates closing of the pouch or container by the user.
In order to obtain a better understanding of the present invention, attention is directed to
The pouch can have a flat configuration as shown in
In the configuration of the pouch 10, the side panels at or near the bottom edge 24 have a natural tendency to extend outwards and away from the contents within the compartment 18. This is shown in
To further assist in the self-supporting nature of the pouches of the present invention, additional embodiments provide reinforcement to the side panels so that they remain in an arc configuration. One method to provide reinforcement is to use a sealing method between the side panels which provides strength to the structure of the pouch. For example, heat sealing and adhesive bonding between the front and back panels and the front and back panels and the bottom panel can result in greater rigidity in the pouch structure by selecting particular heat sealing patterns or adhesive patterns over others. As an example, using a wider heat seal area or a wider adhesive pattern will impart more strength and rigidity than a narrower heat seal area or adhesive pattern. In addition, selection of the adhesive used or the amount of the adhesive used to join the side panels to each other or to the bottom panel can also strengthen the side panels and bottom panel so that the side panels will remain in an arced configuration.
Other methods of reinforcing the pouch so that it maintains the arced configuration include adding additional elements to the pouch. For example, a heat sensitive material could be placed on the bottom panel or on the side panels that will set when exposed to heat or irradiation. When the heat sensitive material is set, it will lock the bottom portion of the side panels or the bottom panel in place such that the lower portion of the front and back side panels are set in the arced configuration. In gas sterilization processes, heat is often used in conjunction with the sterilization gas. This locking of the front and back panels and/or bottom panel will stiffen the pouch a sufficient amount so that the pouch will stay in an upright position during the gas sterilization process.
Other methods of ensuring that the pouch will stay in the arced configuration during the sterilization gas, ensuring that the sterilant will contact the items in the compartment, include providing a bottom panel with sufficient stiffness that will hold the side panels in an arced configuration. Stiffness of the bottom panel can be imparted by a selection of stiffer material for the bottom panel. One method to provide greater stiffness is to select a material for the bottom panel that has a higher basis weight or thickness. In addition, portions of the bottom panel may be treated with a composition which will increase the stiffness in all parts of the bottom panel. Other methods of increasing stiffness of the bottom panel are to provide the bottom panel with pleats. If the bottom panel is provided with accordion pleats, these accordion pleats will tend to resist compression caused by the side panels and the weight of the items in the pouch. Additional elements may also be placed on the bottom panel including materials that will lock in place when taken out of a folded configuration, such as shape memory elements.
Other methods of ensuring that the pouch will stay in the arced configuration are to provide stays on the side panels or the bottom panel. Referring to
In the present invention, suitable materials which may be used as the gas impermeable material include, for example, but are not limited to, polymeric plastic films, foils, paper, paper composites, fibrous webs and the like, laminates of one or more of these materials or a combination thereof of these materials. In addition other materials which are not gas permeable may also be used. The gas impermeable material may be a single layer or a laminate of two or more layers.
Suitable materials can be made from polymeric materials such as polyethylene, polypropylene, polyester, nylon, and the like, as well as any combination thereof. Plastic film materials include, for example, a low density polyethylene (LDPE) film, a LDPE/LLDPE (linear low density polyethylene) film laminate, a LDPE/MDPE (medium density polyethylene) film laminate, a LDPE/HDPE (high density polyethylene) film laminate, a ethylene-vinyl alcohol (EVOH) or the like. In addition, films made from a polyethylene/polypropylene combination may also be used. Films coated with metal coatings, also known as foils may also be used. In one embodiment of the present invention, the film materials used in the present invention include a polyolefin film, such as a polyethylene or polypropylene film. The thickness of the film can essentially be any thickness, provided that the film has sufficient strength that the articles contained within the compartment of the pouch do not puncher or otherwise compromise the film or the pouch.
It is also possible that the gas impermeable material is a laminate of a gas impermeable material and a gas permeable material. Examples of such laminates include, nonwoven/film laminates. These laminates may be beneficial to obtain a cloth-like feel to the outer or inner surface of the pouch or to reinforce or protect the film material from damage caused by the articles in the compartment of the pouch or from elements outside of the pouch.
Essentially any gas permeable material may be used in the present invention, provided that the material is permeable to a sterilizing gas but impermeable to airborne microbes, bacteria, viruses and mixtures thereof. Suitable gas permeable materials useable in the present invention include, for example, medical grade paper, nonwoven materials and other similar gas permeable materials. Generally, gas permeable materials which may be used in the present invention are permeable to water vapor and have a minimum water vapor transmission rate (WVTR) of about 300 g/m2 /24 hours, calculated in accordance with ASTM Standard E96-80. Suitable medical grade paper includes, for example, AMCOR PLP reinforced coated paper available from AMCOR, Limited.
Suitable nonwoven materials useable as the gas permeable material of the pouch of the present invention include, for example, airlaid nonwoven webs, spunbond nonwoven webs, meltblown nonwoven webs, bonded-carded-webs, hydroentangled nonwoven webs, spunlace webs and the like. The method of manufacturing each of these materials is known in the art. Laminates of these materials may also be used.
Of these nonwoven materials, the fibrous material web may comprise a nonwoven meltblown web. Meltblown fibers are formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten fibers into converging high velocity gas (e.g. air) streams that attenuate the fibers of molten thermoplastic material to reduce their diameter, which may be to microfiber diameter. Thereafter, the meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting surface to form a web of randomly disbursed meltblown fibers. Such a process is disclosed, for example, in U.S. Pat. No. 3,849,241 to Butin, et al. Generally speaking, meltblown fibers may be microfibers that may be continuous or discontinuous, and are generally smaller than 10 microns in diameter, and are generally tacky when deposited onto a collecting surface.
The nonwoven material web may be a nonwoven spunbond web. Spunbonded fibers are small diameter substantially continuous fibers that are formed by extruding a molten thermoplastic material from a plurality of fine, usually circular, capillaries of a spinnerette with the diameter of the extruded fibers then being rapidly reduced as by, for example, eductive drawing and/or other well-known spunbonding mechanisms. The production of spun-bonded nonwoven webs is described and illustrated, for example, in U.S. Pat. No. 4,340,563 to Appel, et al., U.S. Pat. No. 3,692,618 to Dorschner, et al., U.S. Pat. No. 3,802,817 to Matsuki et al., U.S. Pat. No. 3,338,992 to Kinney, U.S. Pat. No. 3,341,394 to Kinney, U.S. Pat. No. 3,502,763 to Hartman, U.S. Pat. No. 3,502,538 to Levy, U.S. Pat. No. 3,542,615 to Dobo, et al., and U.S. Pat. No. 5,382,400 to Pike, et al. Spunbond fibers are generally not tacky when they are deposited onto a collecting surface. Spunbond fibers can sometimes have diameters less than about 40 microns, and are often between about 5 to about 20 microns.
The nonwoven material web may also comprise a laminate material such as a spunbond/meltblown/spunbond, or SMS, material. A typical SMS material is described in U.S. Pat. No. 4,041,203 to Brock et al. Other SMS products and processes are described, for example, in U.S. Pat. No. 5,464,688 to Timmons et al.; U.S. Pat. No. 5,169,706 to Collier et al.; and U.S. Pat. No. 4,766,029 to Brock et al. Generally, an SMS material will consist of a meltblown web sandwiched between two exterior spunbond webs. Such SMS laminates have been available commercially for years from Kimberly-Clark Corporation under marks such as Kimguard®). The spunbonded layers on the SMS laminates provide durability and the internal meltblown layer provides porosity.
In another embodiment of the present invention, the permeable material may be a laminate of a film layer and a fibrous material layer which have been laminated together by any lamination technique known to those skilled in the art. Examples of these laminates include, for example, spunbond-film laminates (SF), and other such laminates. Again, it is necessary for the laminate to be gas permeable. In one embodiment, the material for the wrapper component are prepared from a film/spunbond laminate material available from Kimberly-Clark Corp, and known as HBSTL (“highly breathable stretch thermal laminate”), and which material is further disclosed in U.S. Pat. No. 6,276,032, the entire disclosure of which is hereby incorporated herein by reference.
Suitable lamination means which may be used to form the gas permeable laminate materials include, but are not limited to, adhesives, needle punching, ultrasonic bonding and thermomechanical bonding as through the use of heated calendering rolls. Such calendering rolls will often include a patterned roll and a smooth anvil roll, though both rolls may be patterned or smooth and one, both or none of the rolls may be heated. Calendering may also be used to place an aesthetic pattern defined in the laminated material.
Other materials for the gas permeable material and the gas impermeable materials may be used for their properties. For example, if it is necessary for the compartments to be expandable, elastic materials, including elastic webs and elastic nonwovens may also be used. Again, the only requirement is that the one of the panels is gas permeable.
Each of the front and back panels and the bottom panel may have topical treatments applied thereto for more specialized functions. Such topical treatments and their methods of application are known in the art and include, for example, alcohol repellency treatments, anti-static treatments, non-slip treatments and the like, applied by spraying, printing, dipping, or other methods known to those skilled in the art. An example of such a topical treatment is the application of ZELEC® antistatic neutralized mixed alkyl phosphates (available from E.l. DuPont, Wilmington, Del.). Non-slip treatments are placed on the outside of the pouch which aid a user to grab the pouch and open it. Often users must open the pouches wearing protective articles, such as gloves, when the pouch compartment contains items used in a medical procedure. Having gloves donned may make it difficult to open the pouch to retrieve the items contained within the compartment. Non-slip treatments usable in the present invention can be formed in a variety of manners including applying a coating to the entire surface of the pouch or applying a coating in discrete areas on the pouch. The coating should have a higher coefficient of friction than the material used to prepare the pouch. Examples of such non-slip treatments include, but are not limited to, placing an elastomeric material on at least a portion of the surface of one or more side panels or the bottom panel.
In another embodiment of the present invention, the gas permeable material may be prepared from a material which can be electret treated, such as from a polyolefin containing materials. Electret treating the gas permeable material may further enhance the ability of the gas permeable material to prevent airborne microbes, bacteria, viruses and the like from penetrating the gas permeable material. Airborne microbes, bacteria, viruses may be attracted to the gas permeable material due to the electret treatment. Electret treating materials is known in the art and is described in, for example, U.S. Pat. No. 5,401,446. Electret treatment involves subjecting the material to a pair of electrical fields having opposite polarities. Each electrical field forms a corona discharge which is imparted to the material. Other means of electret treating materials are well-known and include process, such as, thermal, liquid contact and electron beam methods.
The panels of the pouch of the present invention may be directly or indirectly connected to one another. When they are directly connected together, techniques known to those skilled in the art, including, but not limited to, heat sealing, stitching, and adhesive sealing. Any method know to those skilled in the art may be used, provided that the panels are sealed together such that the seals are impermeable to airborne microbes, bacteria, viruses and mixtures thereof. Ideally, the sealing or joining should create an air-tight seal. Alternatively, the panels may be joined together with an intervening material. For example, it is possible to place a gas permeable material between the front and back panels and join this gas permeable material to the front and back panels using the same joining techniques described above. This may be advantageous when the front and back panels are each a gas impermeable material and the bottom panel is a gas permeable material. In another embodiment of the present invention, an intervening material may be placed between the front and back panels to facilitate expansion of the pouch when needed. The intervening material may form a gusset to allow the pouch to be expanded as necessary when the pouch is filled. In the alternative, the gas impermeable material may used to join the front and back panels together.
In one embodiment of the present invention, the front and back panels are prepared from a material which is gas impermeable and the bottom panel is prepared from a gas permeable material. In one embodiment of the present invention, the front and back panels are prepared from a polymeric film, such as a polyethylene film and the bottom panel is prepared from a breathable material, such as a nonwoven web, or a medical grade paper. One particular nonwoven web is a spunbond-meltblown-spunbond nonwoven web.
The pouches of the present invention may also be provided with opening devices. As is shown in
Other opening devices types may also be used in the present invention. One popular opening device for breather pouches is a chevron seal, which is shown in
In another embodiment of the present invention, margins where the front and back panels are joined together may peelable to further facilitate opening of the pouch. For the margins to be peelable, the margins when subjected to a suitable tearing stress, are readily separated from one another. Conventional peelable seals or seams are well known to those skilled in the art and the methods of achieving pealable seals or seams are also well known. For example, before joining the front and back panels together, the margins to be sealed are provided with a release coating that will reduce seam strength. Many conventional release coatings may be provided to the margin areas. As a result, a person can use less force to open the pouch or break the seam or seal with less force than would be required to peal the seam or seal apart if the release coating was not applied. Other method of creating a release seal include selecting adhesives which will tend to release when a tearing stress is applied. Examples of such adhesives include pressure sensitive adhesives. It is desirable that the seals or seams in the opening structures shown in
In another embodiment of the present invention, the pouch may be provided with a closing device. Any closing device may be used, provided the closing device can seal the pouch and prevent airborne microbes, bacteria, viruses and mixtures thereof from entering the sealed pouch. Examples of closing devices include tongue and groove sealing devices, adhesives and the like. When an adhesive closing device is used, the adhesive may be protected with a peel strip which is removed before the pouch is sealed. The closing device of the present invention may also double as the opening device.
In a further embodiment of the present invention, the pouch can yet have some additional features. As is shown in
In addition, often the sterilized items are usually transferred to a sterile surface by a sterile person. The contents of a sterilized package are seldom left in or on the opened packaging outsiders who typically open the pouches are not sterile. That is, typically the package or pouch containing the sterilized items often opened by a ‘non-sterile’ person (e.g. circulating nurse) and handed (untouched) to a ‘sterile’ person (e.g. surgeon, attending staff). By having the extra length between the bottom edge and the bottom margin, there is less chance that a non sterile person opening the package would likely touch the sterile items since one of their hands is under the pouch side panels near the bottom panel.
Also shown in
Other features which may be provided to the pouch of the present invention include, providing the pouch with a pre-printed or printable surface. The pre-printed surface would provide information or instructions about opening the package or the contents of the package. The printable surface would be useful for marking with a permanent marker to identify contents of the package or other notes, such as the time and date the item within the pouch was sterilized.
To sterilize the pouch and the items contained within the pouch, the pouch and items contained therein are exposed to a sterilization gas. Typical gas sterilization procedures include, for example, gas plasma sterilization, steam sterilization, ethylene oxide sterilization, hydrogen peroxide sterilization, and ozone sterilization. Typically, the pouch with the items contained therein is placed into a sterilization chamber. In the present invention, suitable sterilization chambers include those which can be used for gas sterilization. While the pouches of the present invention are designed for gas sterilization, this does not mean that other sterilization procedures, such as irradiation, cannot be used with the pouch. It is believed that the pouch of the present invention can be used in most sterilization procedures, provided that the materials in which the pouch is prepared are stable in the sterilization procedure used.
The pouch of the present invention may be placed in the sterilization chamber in an upright position with the top edge of the sterilization container being the uppermost portion of the sterilization container. With the arced side panels acting as legs the pouch is able to support its own weight and stand upright in the sterilization chamber. In an embodiment of the present invention, the pouch of the present invention is able to support its own weight and the weight of the item in the pouch. Stated another way, the pouch is self-supporting with the item contained within the compartment.
When placing the pouch with the item to be sterilized in the sterilization chamber, the user should check to make sure the base of the front and back side panels are arced outward to ensure that the sterilization gas will be able to pass through the gas permeable material of the bottom panel, if the bottom panel is the gas permeable material of the pouch. The pouches may be placed in any order into the chamber provided the gas permeable portion is readily accessible for the gas sterilant. The pouches may be placed in the chamber 110 in an upright configuration, as is shown in
Once the sterilization containers or pouches of the present invention, containing the items to be sterilized are placed in the sterilization chamber, containing the sterilization chamber is closed, and a gas sterilant is introduced into the container. The amount of time the items in the compartment are subjected to the gas sterilant depends on various factors, including the type of gas sterilant used, the number of sterilization container placed in the the sterilization container as well as other factors. Those skilled in the art will be able to determine the appropriate amount of time the gas sterilant should remain in the chamber based on these and other factors.
Once sterilized, the sterilization containers are removed from the chamber and the container or pouch with the sterilized items contained therein are stored or placed for use. The sterilization containers of the present invention have some advantages, some of which are described above. One big advantage is the items in the chamber can be dispensed from the container when the container is in an upright position. By having the sterilization container able to dispense the sterilized item from an upright position, the amount of sterile surface space needed in the pre-operating room for dispensing the items can be greatly reduced. That is, sterilized items are usually transferred to a sterile surface. The contents or items in a sterilized package are seldom left in the opened pouch or left on the outside of the opened packaging, since the outsides are not sterile. Typically, the package is opened by a ‘non-sterile’ person (e.g. circulating nurse) and handed (untouched) to a ‘sterile’ person (e.g. surgeon, attending staff). The opening feature of the present invention further provides this upright container dispensing, in conjunction with the self supporting feature of the pouch or sterilization container of the present invention.
In another embodiment of the present invention, the item to be sterilized is first placed into the compartment of the pouch or container and the container is closed or sealed. This is typically by closing the closing device on the pouch or container.
Typical items which may be sterilized in the pouch of the present invention include items that are used in medical procedures which need sterilization. Examples of such items include, for example, a protective garment, a protective covering, a wound covering, a suture, a clamp, a scalpel, a retractor, forceps, scissors, a blade handle, a glove, a needle, a sponge, a syringe, a receptacle, a sealed vessel holding a therapeutic agent or a combination thereof, in addition other items used in medical procedures not specifically mentioned. Each pouch may contain one or several of items in the compartment of the pouch.
The pouch of the present invention could also be used as a container for other various items, which will readily apparent to those skilled in the art.
Those skilled in the art will recognize that the present invention is capable of many modifications and variations without departing from the scope thereof. Accordingly, the detailed description and examples set forth above are meant to be illustrative only and are not intended to limit, in any manner, the scope of the invention as set forth in the appended claims.
