US20140270583A1

US20140270583A1 - Dual Sterile Pouch and Sealing Mechanisms for the Containment of a Non-Sterile Device

Info

Publication number: US20140270583A1
Application number: US14/214,905
Authority: US
Inventors: Edwin K. Anderson
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-03-15
Filing date: 2014-03-15
Publication date: 2014-09-18

Abstract

A dual sterile pouch and sealing mechanism for the sterile containment and usage of a non-sterile device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/801,851 entitled “Dual Sterile Pouch and Sealing Mechanisms for the Containment of a Non-Sterile Device,” filed Mar. 15, 2013, from which priority is claimed under 35 U.S.C. 119, and the disclosure of which is hereby incorporated herein by reference in its entirety.

TECHNICAL FIELD

This invention relates to improved devices and methods used for the isolation of non-sterile product for use in a controlled environment. More specifically, this invention relates to the isolation and containment of non-sterile product, non-sterile communication devices, and/or portable electronic devices, in a double pouch with improved sealing mechanisms for use in a controlled environment (i.e., sterile and/or cleanroom environment).

BACKGROUND

Portable electronic devices and/or any mobile communication devices have become an integral part of people's lives. They are commonly used for a variety of personal and professional reasons, such as personal and/or professional scheduling, accessing medical information, mapping, internet, camera use, accessing drug information and e mails.
For example, there is a common practice to use mobiles and PDAs by surgeons in controlled environments, i.e., Operating Room (OR), for both personal and/or professional use. Surgeons commonly use mobile cameras to take photographs intra-operatively in case of non-availability of professional cameras. Many surgeons use mobiles and PDAs to play live or recorded music during surgeries. In at least one instance, a study found that 66% of surgeons used their phones in the hospitals for a variety of tasks, including in operating theatres and intensive care units. However, the transfer of a non-sterile device into a controlled environment can create a significant barrier to the use of such devices, and can pose many challenges to device usage in the manufacturing and healthcare industries.
The current practice for the transfer of non-sterile devices in a healthcare sterile environment typically involves two users, one sterile user in the “sterile environment” and one non-sterile assistant, to transfer a non-sterile device inside the controlled environment. The non-sterile assistant begins by bringing the non-sterile device into the controlled environment; non-sterile devices often require pre-cleaning to ensure gross contaminants do not adversely affect the controlled environment. The sterile user holds a sterile receptacle for receipt of the non-sterile device from the non-sterile assistant. Once the device is within the sterile receptacle, the sterile user then attempts to seal the sterile receptacle without compromising the sterile “barrier” of the user. If successful, use of the non-sterile device inside of the sterile container may commence. This technique significantly differs from common industry practices for the transfer of a pre-sterilized device into a controlled environment. Furthermore, a completely aseptic transfer of the non-sterile device is often difficult and may lead to a contamination of the sterile field, subsequently resulting in surgical delays and significant added expense.

BRIEF SUMMARY OF THE INVENTION

One feature of the present invention includes the realization of a need to improve the aseptic transfer of non-sterile devices into a controlled environment, by (i) reducing the number of users introduced to the contaminated device, (ii) eliminating the pre-cleaning used to bring a grossly contaminated device into the controlled environment, (iii) improving any necessary transfer techniques between users to better align with common industrial practices, and (iv) desirably provide for one-handed operation.
This invention provides the users in a controlled environment a variety of devices, systems, methods and techniques that can be used to contain and seal a non-sterile portable electronic device into a sterile pouch prior to entry of the user and/or device into the sterile environment. A non-sterile device may include, but not limited to, portable product/equipment, portable electronic devices, and/or any communication devices such as cameras, video recorders, mobile phones, mobile computers, personal digital assistants (PDA's), laptops, notebooks, tablets, e-readers, and/or any combination thereof. Furthermore, exemplary non-sterile devices for use in controlled and/or “clean” environments could include devices used as a matter of convenience to a manufacturing clean room operator, or as lifesaving tools for a physician in an intensive care unit or operating room.
In one exemplary embodiment, the device may comprise of at least two pouches; one pouch (referred to as the “inner” pouch) is sealed within the supplementary pouch (referred to as the “outer” pouch). The pouches may be provided in such a way to allow for an opening of the inner pouch on one side for insertion of a non-sterile device. The inside surface of the inner pouch can be non-sterile (although sterile inner surfaces could be provided with no loss of utility), while the surfaces sealed between the inner and outer pouches are provided sterile.
In another embodiment, the at least two pouches may be manufactured from various transparent polymeric materials that allows a surgical gloved sterile user to have optimal manipulation and tactile control of a non-sterile device, as well as provide resistance to scratches, tears, and/or punctures when or if a surgical and/or manufacturing tool comes into contact with the pouches.
In another embodiment, sizes of the inner pouch and outer pouch may vary. The inner pouch could be manufactured in multiple sizes to allow for a tight fit around the small non-sterile device (i.e., a small mobile phone) while a larger pouch could be manufactured for a large touchscreen tablet. If desired, alternative embodiments could allow for reducing the size of the inner and outer pouches, such as by providing adhesive tabs within the pouches to allow the pouches to be “resized” at a user's option to match a desired device and/or usage environment (i.e., tightly wrapping the device).
In another embodiment, the invention may comprise one or more of a variety of sealing mechanisms. In one embodiment, the sealing mechanisms may be actuated by a user's interaction with internal peel tabs or external heat sources, which could be used to close the inner pouch desirably without violating the sterile surface between the inner and outer pouch. Once the inner pouch is sealed in any manner, one or more standard or universal aseptic transfer techniques could be employed to introduce the inner pouch into the controlled environment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a top view of one embodiment of an exemplary pouch assembly constructed in accordance with various teaching of the present invention, with this embodiment including an Internal Peel Stick-Tab mechanism;

FIG. 2 depicts a top view of an alternative embodiment of an exemplary pouch assembly incorporating features for use with an External Heat Seal mechanism;

FIG. 3 depicts an isometric view of an embodiment of an exemplary pouch assembly including the Internal Peel Stick-Tab Design of FIG. 1;

FIG. 4 depicts an isometric view of an embodiment of an exemplary pouch assembly including the External Heat Seal Design of FIG. 2;

FIGS. 5A-5C illustrates one exemplary process of the pouch assembly of FIG. 1, showing an Internal Peel Stick-Tab Design Seal Process Diagram;

FIG. 6 depicts a further process of exposing an external sterile pouch surface of the pouch assembly with Internal Peel Stick-Tab Design for acceptance by a user in the sterile field;

FIG. 7 depicts a further process of removing the sterile inner pouch from the pouch assembly with Internal Peel Stick-Tab Design;

FIG. 8 depicts a further process of exposing an external sterile pouch surface of the pouch assembly with External Heat Seal Design for acceptance by a user in a controlled environment; and

FIG. 9 depicts a further process of removing the sterile inner pouch from the pouch assembly with External Heat Seal Design.

DETAILED DESCRIPTION

The various features of the disclosure and the inventions described herein may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The following and foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. The scope of the invention is thus intended to include all changes that come within the meaning and range of equivalency of the descriptions provided herein
In one exemplary embodiment, the device may comprise two pouches; one pouch (referred to as the “inner” pouch) is sealed within the supplementary pouch (referred to as the “outer” pouch). The pouches are provided in such a way to allow for an opening of the inner pouch on one side for insertion of a non-sterile device. The inside surface of the inner pouch can be non-sterile, while the surfaces sealed between the inner and outer pouches are desirably provided sterile. Various sealing mechanisms, including self-closing seals, internal peel tabs and/or external heat sources or other sealing devices can be used to close the inner pouch without violating the sterile surface between the inner and outer pouch. Once the inner pouch is sealed, universal aseptic transfer techniques may be employed to introduce the inner pouch to the controlled environment.
In various exemplary embodiments, a device such as described herein may include one or more pre-sterilized surfaces that are contained within a sterile environment, such as between the inner and outer pouch, and the device may include a sealing mechanism that can be utilized to close the inner and/or outer pouches without violating the pre-sterilized surfaces. The various embodiments of the invention may include two separate sealing mechanism designs, if desired. In one exemplary embodiment, the pouch may utilize an internal peel stick-tab mechanism (i.e., see FIGS. 1 and 3), while various the alternative embodiments could utilize other sealing mechanisms and/or techniques, such as an external heat source, to seal the inner pouch (see FIGS. 2 and 4).
FIG. 3 depicts one exemplary embodiment of an internal peel stick-tab pouch assembly 10. The internal peel stick-tab pouch assembly 10 may comprise at least one inner pouch 20, at least one outer pouch 30, and/or at least one internal peel stick-tab mechanism 40. FIG. 4 depicts one exemplary embodiment of an external heat seal pouch assembly 100. The external heat seal pouch assembly may comprise at least one inner pouch 60, at least one outer pouch 70, and at least one external heat seal pouch mechanism 80.
In various exemplary embodiments, the inner pouch 20, 60 and/or the outer pouch 30, 70 may be manufactured from various transparent heat or other technique sealable polymeric materials, which can desirably allow a surgical gloved sterile user to control and/or view the non-sterile device contained within the inner pouch 20, 60. For example, the surgical gloved sterile user may desirably perform single or multi touch gestures used for direct manipulation through tactile control of a non-sterile device such as a mobile phone.
In another embodiment, the inner pouch 20, 60 and/or the outer pouch 30, 70 may be manufactured from one or more polymeric layers. The inner pouch 20, 60 and/or the outer pouch 30, 70, including the one or more layers, may comprise a single layer or comprise multiple polymeric materials and/or polymeric coatings, for example but not limited to Polyethylene Terephthalte. The wall thickness of the inner pouch 20, 60 and/or outer pouch 30, 70 may range from 0.05 mm to 20 mm thick. The inner pouch 20, 60 and/or outer pouch 30, 70 may also include materials and/or features that render the pouch scratch, tear, and puncture resistant, such as where a surgical tool may come into contact with the inner pouch.
In another embodiment, the inner pouch 20, 60 and/or outer pouch 30, 70 could be manufactured in a variety of multiple sizes, desirably to allow for a tight fit and/or loose fit (whichever desired) around a non-sterile device. For example, a smaller inner pouch could be manufactured for a small mobile phone while a larger pouch could be manufactured for a large touchscreen tablet. The inner pouch 20, 60 and/or outer pouch 30, 70 may be assembled with two different sizes. For example, if desired, the inner pouch 20, 60 could be manufactured to fit a small mobile phone while the outer pouch could be 0.5 times to 4 times larger than the inner pouch. In other embodiments, the inner pouch 20, 60 and/or outer pouch 30, 70 may be fabricated from various types of microbial resistant or porous materials. Such materials may include medical grade heat sealable materials resistant to microbial penetration, including Tyvek®, Ovantex®, biaxially-oriented polyethylene terephthalate, or other polymeric materials of varying thickness, such as from 1 mm to 20 mm, and various materials could be used where the pore size may be customized to minimize and/or inhibit the passage and/or generation of particles when the pouch is opened.
In another exemplary embodiment, the inner pouch 20, 60 and/or outer pouch 30, 70 could be fabricated from materials that protect against various additional adverse external influences they might encounter. For example, such materials could protect the non-sterile device from anti-static, moisture, light, temperature variations, absorption of chemicals, and/or any combination thereof to prevent adverse effects on the function of the non-sterile device and/or any mechanical damage.
In various embodiments, the inner 20, 60 and/or outer pouches 30, 70 might be designed into a variety of shapes, colors and or sizes to accommodate a wide variety of non-sterile devices and/or specific uses and/or use environments. For example, it may be desirable to make the inner pouch 20, 60 a blue transparent color that could help the user identify a suitable and/or appropriate inner pouch for non-sterile device placement, while the outer pouch 30, 70 could remain a clear, transparent color. Alternatively, the inner pouch 20, 60 might be transparent and the outer pouch 30, 70 may be red transparent or opaque, with the differing colors assisting with identifying the type of non-sterile device that should be placed into the inner pouch, as well as whether the inner pouch and/or outer pouch is still exposed and/or attached to the device.
In another alternate embodiment, the pouches may be designed with plurality of pouches within a single device, which could provide additional protection and/or multiple use functionality. Furthermore, any of the embodiments described herein may be designed as disposable pouches and/or single use.
FIG. 1 depicts a top view of one exemplary device incorporating an internal peel stick-tab pouch assembly 10. In various embodiments, the internal peel stick-tab mechanisms 40 may be manufactured from medical grade adhesives, such as epoxies, acrylics, styrenic block co-polymers, and other polymeric materials.
In various embodiments, the internal peel stick tab mechanisms 40 may be placed in one or more locations within the inner pouch 20, 60 and/or outer pouch 30, 70. The one or more internal peel stick-tab mechanisms 40 may be added to specific locations within the inner pouch to bond the inner pouch to the device contained within the inner pouch, which could also be utilized to prevent the inner pouch from sliding and/or shifting relative to the device and/or inhibit folding and/or pinching of the inner pouch. If desired, one or more peel stick-tab mechanisms 40 may be incorporated into the inner pouch design and used to resize the inner pouch in a desired manner. In various alternative embodiments, one or more internal peel stick tab mechanisms 40 may be placed on the outer pouch for a variety of reasons, see FIG. 1.
In various embodiments, other closure mechanisms may be used to seal or close the inner pouch 20, 60 and/or outer pouch 30, 70. Such other sealing or closing mechanisms that may be used include, for example, peel pouch seals 50, 90 (as seen in FIGS. 1 and 2), Ziploc, press'n'seal, and/or a variety of other similar mechanisms known in the art.
Inner and Outer Pouch Assembly Process
FIG. 3 depicts an isometric view of one exemplary embodiment of an internal peel stick-tab pouch assembly 10. In various embodiments, the outer pouch 30 could be assembled using two rectangular pieces of material that can be heat sealed on three sides to form a pouch that is opened on one remaining side (not shown). On one edge of the outer pouch, a non-sealed material section could remain outside the seal surface, and this section could be referred to as the “peel corner” 110 (see FIG. 3). There may be one or more peel corners 110 available at various locations.
In other alternative embodiments, the inner pouch 20 may be formed in a similar manner to the outer pouch 30, which could include construction without a peel corner, or the inner pouch could be injection formed as a single pouch, also desirably without a peel corner (not shown). The inner pouch 20 may be inserted into the outer pouch 30 and may be subsequently permanently attached or temporarily attached to the outer pouch 30. Such temporary attachments may include perforations, serrations, and/or any other attachments known in the art. Peel stick-tab mechanisms 40 could be used, such as adhesive incorporating materials manufactured from medical grade adhesives, such as epoxies, acrylics, styrenic block co-polymers, and other polymeric materials, which can then be inserted into “area one” of FIG. 1. The outer pouch 30 can be folded in such a manner as to enclose a surface portion of the inner pouch at the end of the inner pouch 20, such as depicted in FIG. 1. The outer pouch 30 can then be heat sealed 50 on the fourth side, if desired, to the outer surface of the inner pouch 20; a heat guard and/or shield 70 may be placed in the inner pouch 20 to prevent the inner pouch 20 from sealing closed. Additional peel stick-tab mechanisms 40 may be inserted in “area two,” such as seen in FIG. 1. A shield 70 might be employed, used and/or added to the peel stick-tabs in area two, such as seen in FIG. 1. Once substantial assembly of the device has been completed, the entire assembly may then be sterilized using a wide range of sterilization processes, ethylene oxide, e-beam, gamma, or other methods known in the industry.
In use, a device may be selected by a user, who can carry the device in a non-sterile manner to the location of use. Because the outer surface of the outer pouch can become non-sterile without affecting the sterile condition of the inner pouch, it is not necessary to maintain the device in sterile storage conditions. Once the area of use is reached, the outer and inner pouches may be opened along a common opening or seam, and a non-sterile device 130 can be inserted into the inner pouch 20 by the non-sterile user. If desired, the non-sterile user may use the peel stick tab mechanisms 40 in the inner pouch 20 to resize the inner pouch, or adhere the inner pouch 20 to the device 130 (as seen in FIG. 5A). The non-sterile user can then removes the shield 70 located in area two, and will desirably press down 140 on the outer pouch 30 to seal the exposed peel stick-tab mechanisms 40 (see FIG. 5B and FIG. 5C). The fold of the outer pouch 30 can then be pulled outward 150 by the user to reveal the peel stick tab mechanisms 40 in area one, while simultaneously sealing the outer pouch 30. The non-sterile device is now sealed within the sterile inner pouch, which is also contained within the outer pouch.
Because the outer surface of the outer pouch is typically non-sterile, the outer pouch can be grasped by the non-sterile user and presented to the user within the sterile field. The non-sterile user can the open the outer pouch along a desired opening or seam and the parties can employ standard aseptic transfer techniques when the non-sterile user “presents” the inner pouch 20 to the sterile user (with the non-sterile user only contacting the outer pouch), and the transfer of the sterile inner pouch to the sterile field can be effected without transferring harmful microorganisms to the sterile field. In various exemplary embodiments, the non-sterile user could pull the peel corners 110 (see FIG. 3) of the outer pouch 30 away from each other 160, making sure not to contact the inner pouch 20 with a non-sterile surface (see FIG. 6). The sterile user may then touch, grab and/or take possession of the inner pouch 20 and aseptically remove the inner pouch 20 from the outer pouch 30, again making sure not to contact the outer non-sterile surfaces, while the non-sterile user holds on to the outer pouch 30. The sterile user can then place the inner pouch 20 that contains the non-sterile device 130 into the sterile field (see FIG. 7), without contacting a non-sterile surface or damaging the inner pouch 20.
FIG. 4 shows another alternative embodiment of a pouch assembly 100, in which the device incorporates sealing techniques that utilize an external heat sealing device. In this embodiment, the outer pouch assembly can begin with two rectangular pieces of material that can be heat sealed on three sides to form a pouch that is opened on one side. On one edge of the outer pouch 70, a non-sealed material section can desirably remain outside of the seal surface, with this section referred to herein as the “peel corner” 120 (see FIG. 4). The outer pouch 70 may include one or more peel corners 120. The inner pouch 60 may be formed in a similar manor to the outer pouch, including the creation of pouches with or without a peel corner, or injection formed as a single pouch also with or without a peel corner. The inner pouch 60 can be placed inside the outer pouch 70 and the fourth side of the outer pouch could be heat sealed 80 to the inner pouch 60 (see FIG. 2). If desired, a heat guard and/or shield may be used to prevent the inner pouch from becoming sealed closed. The entire assembly may then be sterilized using a wide range of sterilization processes, ethylene oxide, e-beam, gamma, or other methods known in the industry.
In a manner similar to the steps described previously, the non-sterile user could inserts a non-sterile device 170 into the inner pouch 60 (see FIG. 8) and the non-sterile user may use the adhesive strips (not shown) in the inner pouch to resize the inner pouch 60, or adhere the inner pouch 60 to the device. An external heating device may then be used to heat seal 80 the inner 60 and outer pouch 70, such as seen in FIG. 2. Once the external heat is applied, aseptic transfer techniques could then be used to present the inner pouch 60 to the sterile user, without transferring harmful microorganisms to the sterile field. The non-sterile user could pull the peel corners 20 (see FIG. 4) of the outer pouch 70 away 180 (see FIG. 8) from each other, desirably making sure not to contact the inner pouch 60 with a non-sterile surface as seen in FIG. 8. The sterile user may then aseptically remove the inner pouch 60 with the non-sterile device 170 from the outer pouch 70 and place the inner pouch 60 with the non-sterile device 170 into the sterile field (see FIG. 9).
The various headings and titles used herein are for the convenience of the reader, and should not be construed to limit or constrain any of the features or disclosures thereunder to a specific embodiment or embodiments. It should be understood that various exemplary embodiments could incorporate numerous combinations of the various advantages and/or features described, all manner of combinations of which are contemplated and expressly incorporated hereunder.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., i.e., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments of this invention are described herein, including the best mode known to the inventor for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventor intends for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

What is claimed:

1. A device for operating a non-sterile portable electronic device in a sterile environment, comprising:

a first pouch formed from a substantially flexible, transparent polymeric material, the first pouch having a sealed periphery and at least one opening proximate to a top edge of the first pouch, the first pouch having an inner surface and an outer surface;

a second pouch formed from a substantially flexible material, the second pouch having a sealed periphery with at least one opening proximate to a top edge of the second pouch and an openable closure proximate to a bottom edge of the second pouch;

the first pouch being disposed within the second pouch, the opening edges of the second pouch overlapping the opening edges of the first pouch; the overlapping edges of the first and second pouches being releasably adhered to each other to form a sterile region between the first and second pouches;

a first adhesive region disposed within the inner surface of the inner pouch proximate to the top edge of the first pouch; and

the openable closure located distal to the openings of the first and second pouches.