US20140124397A1

US20140124397A1 - Vacuum loss indication for flexible packaging

Info

Publication number: US20140124397A1
Application number: US14/070,217
Authority: US
Inventors: Steven BOGGS; Daniel Dunifer
Original assignee: Alphatec Spine Inc
Current assignee: Atec Spine Inc
Priority date: 2012-11-08
Filing date: 2013-11-01
Publication date: 2014-05-08

Abstract

A system for vacuum loss indication includes a rigid inner container, a flexible outer container, a sliding block, and a bias mechanism. The rigid inner container includes a receptacle with an open proximal end and a closed distal end. The flexible outer container surrounds the inner rigid container and includes a semi-transparent portion. The sliding block is within the receptacle and visible through the semi-transparent portion and includes a pressure indicator. The bias mechanism biases the sliding block to a first position under a first level of vacuum and a second position under a second level of vacuum. A first portion of the pressure indicator is visible through the semi-transparent portion in the first position and a second portion is visible through the semi-transparent portion in the second position.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional Application Ser. No. 61/723,916 entitled “Vacuum Loss Indication for Flexible Packaging” which was filed on Nov. 8, 2012 and is incorporated herein by reference in its entirety.

FIELD

The present disclosure generally relates to the field of packaging, and more particularly to systems, methods, and devices for vacuum loss indication for flexible packaging.

BACKGROUND

Vacuum packing or vacuum packaging is a method of packaging that removes air from the package prior to sealing. It can involve both rigid and flexible types of packaging. The intent is usually to remove oxygen from the container to extend the shelf life of various products and, with flexible package forms, to reduce the volume of the contents and package. Vacuum packing reduces atmospheric oxygen, limiting the growth of contaminants such as aerobic bacteria and fungi. Vacuum packaging is commonly used in connection with sterile and disposable packaging for instruments, devices, biologic materials, and various other applications in the medical field or food industry.
Loss of this vacuum may lead to development of contaminants described above and compromise safety or sterility of the contents. For example, flexible packaging may become easily damaged through shipping or handling causing release of the vacuum. Alternatively, micro-pores within the packaging materials may release vacuum over time while the packaging remains in inventory. For the many applications in the medical field utilizing flexible packaging, it is essential to know whether the packaging maintains a sufficient vacuum over time. Often, vacuum loss may be discovered by visually inspecting the packaging itself.
In some cases, the packaging material itself may create difficulty when determining whether the packaging continues to maintain sufficient vacuum. For example, the material may include clear plastics that reduce the ability to discern whether the material conforms to the edges of the contents tightly. The material may include graphics, labeling, or other confusing markers that restrict visibility of the contents inside the packaging. In other cases, the material may also conform to the shape of the contents upon application of the initial vacuum. As the vacuum releases, the material may not return to its original shape prior to application of the initial vacuum. For example, the material may become more rigid as it stretches or changes shape. The material may become more rigid due to conditions found in storage such as lower temperatures.
One example of an indicator of vacuum loss is disclosed in U.S. Pat. No. 4,295,566, entitled “Air-Evacuated Package with Vacuum Integrity Indicator Means” filed May 7, 1980 and issued to Vincek Oct. 20, 1981. However, a reliable, highly-visual vacuum loss indicator would alleviate many of the problems associated with the subjectivity of current vacuum loss inspection and detection methods associated with flexible pouches.

SUMMARY

A system for vacuum loss indication includes a rigid container, a flexible container, and an indicator member. The flexible container surrounds the rigid container to maintain a pressure. The indicator member is disposed between the rigid container and the flexible container and includes a first position when the pressure is at a first pressure and a second position when the pressure is at a second pressure greater than the first pressure.
In other features, the system includes a bias member that couples the indicator with the rigid container and biases the indicator member to the second position. The indicator member includes a visible indicator that is hidden from view through a transparent portion of the flexible container in the first position and visible through the transparent portion in the second position. A vacuum sealed container is disposed within a cavity of the rigid container. A receptacle receives the indicator member and only an upper surface of the indicator member is visible through a transparent portion of the flexible container in the first position. At least one side surface of the indicator member is visible through the transparent portion of the flexible container in the second position.
A system for vacuum loss indication includes a rigid inner container, a flexible outer container, a sliding block, and a bias mechanism. The rigid inner container includes a receptacle with an open proximal end and a closed distal end. The flexible outer container surrounds the inner rigid container and includes a semi-transparent portion. The sliding block is within the receptacle and visible through the semi-transparent portion and includes a pressure indicator. The bias mechanism biases the sliding block to a first position under a first level of vacuum and a second position under a second level of vacuum. A first portion of the pressure indicator is visible through the semi-transparent portion in the first position and a second portion is visible through the semi-transparent portion in the second position.
In other features, the flexible outer container includes a vacuum pouch. The bias mechanism includes a coil spring. The rigid inner container further comprises a cavity containing a medical device. The medical device includes a pre-packaged, vacuum-sealed container. The first portion includes a first color and the second portion includes a second color.
A system for vacuum loss indication of a medical device container includes a rigid inner container with a cavity, a flexible outer container, a sliding block, and a spring. The rigid inner container includes a receptacle with a closed distal end and an open proximal end. The cavity within the rigid container contains a medical device. The flexible outer container surrounds the rigid inner container and includes a transparent portion disposed adjacent the receptacle. The sliding block is disposed within the receptacle and includes a first portion with a first color and a second portion with a second color. The spring couples the sliding block to the distal end of the receptacle. The flexible outer container compresses the sliding block within the receptacle to obstruct visualization of the second portion when the flexible outer container includes a first pressure. The spring biases the sliding block to permit visualization of the second portion above the open proximal end when the flexible container includes a second pressure greater than the first pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary system for vacuum loss indication for flexible packaging according to the principles of the present disclosure.

FIG. 2 is a perspective view of a portion of the exemplary system of FIG. 1 in a first state indicating a first vacuum level according to the principles of the present disclosure.

FIG. 3 is a perspective view of the portion of the exemplary system of FIG. 2 without a flexible pouch according to the principles of the present disclosure.

FIG. 4 is a partially exploded perspective view of the portion of the exemplary system of FIG. 2 without a flexible pouch according to the principles of the present disclosure.

FIG. 5 is a perspective view of a bottom side of the exemplary system of FIG. 3 without the flexible pouch according to the principles of the present disclosure.

FIG. 6 is an exploded perspective view of the exemplary system of FIG. 1 including a bias mechanism, a sliding block, and a receptacle of a rigid container according to the principles of the present disclosure.

DETAILED DESCRIPTION

Accordingly, the present disclosure includes exemplary systems, devices, and methods that provide reliable, highly-visible vacuum loss indication. In one example, a system for vacuum loss indication may include a flexible pouch, a rigid container, a sliding block within the container, and a bias mechanism between the sliding block and the container. The flexible pouch may include a clear plastic membrane resistant to vacuum loss. The rigid container may include a three-dimensional block comprised of a rigid plastic, metal, or other suitable material. The rigid container includes a receptacle for receiving the sliding block. The rigid container may also include a cavity for receiving the device, biologic, instrument or other product that requires vacuum storage. The sliding block may include various color, marking, or texture indications on one or more surfaces. The indications may include bright, high-contrast, and/or bold appearance comparatively with the flexible pouch. The bias mechanism may include a spring or other means of restoring force disposed between a surface of the sliding block and a surface within the receptacle.
The system may be assembled by inserting the various components inside the flexible pouch. First, the bias mechanism may be inserted into the receptacle of the rigid container until it reaches a distal surface. The sliding block may be inserted into the receptacle until a distal surface contacts a proximal side of the bias mechanism. A proximal surface of the sliding block may extend past a proximal surface of the rigid container such that one or more of the indications may be visible. The packaged product may be inserted into the cavity of the rigid container. Finally, all contents may be may be inserted into the flexible pouch and vacuum applied.
Under sufficient, sealed vacuum, the sliding block may be compressed by ambient pressure causing the bias mechanism to collapse further into the receptacle. One or more of the indications may no longer be visible as the proximal surface of the sliding block may sink below the proximal surface of the rigid container. When vacuum loss occurs, the bias mechanism may force the sliding block proximally and cause one or more of the indications to become visible again. The change in indication may be used to determine various levels of vacuum loss. The bias mechanism includes sufficient force to counteract any shape memory that may occur due to the flexible pouch conforming to the shape of the rigid container.
Embodiments of the invention will now be described with reference to the Figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the invention described herein. The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of an instrument nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant.
Referring now to FIG. 1, an exemplary system 100 for vacuum loss indication includes a flexible pouch 102, a rigid container 104, and a sliding block 106. The rigid container 104 may include a cavity 108 for receiving a medical product such as an implant, instrument, biologic, and the like. The cavity 108 may be open on both a proximal side and a distal side of the rigid container 104 such that the flexible pouch 102 also retains the product therein when under a vacuum. The flexible pouch 102 may include a transparent window 110 on a proximal side such that the contents of the flexible pouch 102 are visible to the naked eye. The flexible pouch 102 may be substantially gas impermeable to ensure maintenance of vacuum over sustained periods of time. In some examples, the flexible pouch 102 may be semi-transparent, opaque, translucent, or non-clear.
The rigid container 104 may be comprised of a plastic, metal, fiberglass, or any other suitable material such that under vacuum, the overall shape of the cavity 108 may be maintained. The rigid container 104 forms a frame of support for the system 100 and may include various features to reduce weight and increase rigidity. The rigid container 104 further includes a receptacle 112 for housing the sliding block 106 as illustrated in FIG. 2. For example, the receptacle 112 may include an opening 114 on a proximal side of the rigid container 104 that extends distally a depth towards the distal side of the rigid container 104. The sliding block 106 may include an outer profile that corresponds to the opening 114 to enable sliding engagement as the sliding block 106 translates proximally and distally within the receptacle 112.
FIG. 3 illustrates interaction of the sliding block 106 within the receptacle 112 to indicate various levels of vacuum inside a flexible pouch. For example, the sliding block 106 may include a proximal side 116 with a first color indication. An outer side 118 of the sliding block 106 may include one or more colors. For example, a proximal portion A of the outer side 118 may include a second color while a distal portion B of the outer side 118 may include a third color. Each color may be used to indicate various levels or amounts of vacuum within the flexible pouch 102. As different colored portions of the sliding block 106 become visible, different levels of vacuum may be inferred.
Referring now to FIG. 4, removal of the sliding block 106 reveals the receptacle 112 containing a bias mechanism 120 that may translate the sliding block 106 within the receptacle 112. For example, a distal side of the sliding block 106 opposite the proximal side 116 may engage with a proximal end of the bias mechanism. Referring also now to FIG. 5, the distal end of the receptacle 112 may include a closed end 122 that engages the distal end of the bias mechanism 120. The closed end 122 may form a pocket with a single open proximal end through which the sliding block 106 may be visible. The distal side of the rigid container 104 may include additional pockets, ridges, webbing, or other structural features that maintain structural integrity under vacuum and/or reduce material use and weight.
The bias mechanism 120 may include, for example, a coil spring as illustrated in FIG. 6. Under a first level of vacuum, the bias mechanism 120 may be compressed such that the sliding block 106 translates distally into the receptacle 112. Under a second level of vacuum that is less than the first level of vacuum, the bias mechanism 120 may expand such that the sliding block 106 translates proximally relative to the receptacle 112. In some examples, the sliding block 106 may include one or more retention members that engage stops within the receptacle 112 to prevent over extension of the sliding block 106. In various examples, the bias mechanism 120 may include other types of springs or compressed gases.
The flexible pouch 102 may compress the sliding block 106 into the receptacle 112 under the first level of vacuum and the bias mechanism 120 may bias the sliding block 106 until a portion of the sliding block 106 extends outside the receptacle 112. For example, the flexible pouch 102 may compress the sliding block 106 within the receptacle 112 by engagement with the proximal side 116 and therefore obstruct visualization of the outer side 118 when the flexible pouch 102 includes a first pressure. The bias mechanism 102 biases the sliding block 106 to permit visualization of the outer side 118 above the open proximal end 114 when the flexible pouch 102 includes a second pressure greater than the first pressure, such as when a vacuum leak has occurred. Thus, the sliding block 106 may provide a visual indication of vacuum loss that may be difficult to discern as most of the flexible pouch 102 may retain the basic shape of the rigid container 104 it surrounds. The sliding block 106 may force a portion of the flexible pouch 102 away from the rigid container 104 and permit visualization of one or more colors on one or more sides/faces of the sliding block 106.
Examples of the systems for vacuum loss indication disclosed here include the rigid container 104, the flexible container 102 surrounding the rigid container 104 to maintain a pressure, and the sliding block 106 or indicator member between the rigid container 104 and the flexible container 102 that includes a first position when the pressure is at a first pressure and a second position when the pressure is at a second pressure greater than the first pressure. The bias member 120 couples the indicator member 106 with the rigid container 104 and biases the indicator member 106 to the second position. The indicator member 106 includes a visible indicator, such one or more colored portions as shown in FIG. 3 that is hidden from view through a transparent portion of the flexible container 102 in the first position and visible through the transparent portion in the second position. A vacuum sealed container may be disposed within the cavity 108 of the rigid container 104. The receptacle 112 that receives the indicator member 106 may permit only an upper surface 116 of the indicator member 106 to be visible through a transparent portion of the flexible container 102 in the first position. At least one side surface 118 of the indicator member 106 is visible through the transparent portion of the flexible container 102 in the second position.
The rigid inner container 104 may include the receptacle 112 with the open proximal end 114 and a closed distal end 122. The flexible outer container 102 surrounding the inner rigid container 104 may include a transparent or a semi-transparent portion. In other examples, the flexible outer container 102 may be completely transparent or semi-transparent. The sliding block 106 within the receptacle 112 is visible through the semi-transparent portion and includes a pressure indicator comprising one or more portions such as proximal side 116 and outer sides 118 with color indicators at A and B. The bias mechanism 120 biases the sliding block 106 to a first position under a first level of vacuum and a second position under a second level of vacuum. A first portion of the pressure indicator is visible through the semi-transparent portion in the first position and a second portion is visible through the semi-transparent portion in the second position. The first portion includes a first color and the second portion includes a second color. The flexible outer container 102 may include a vacuum pouch. The bias mechanism includes a coil spring 120. The rigid inner container 104 further comprises a cavity 108 containing medical device such as a biologic agent, interbody cage, or other implant. The medical device may be contained within a pre-packaged, vacuum-sealed container.
Examples of medical devices and biologic agents that may be used in conjunction with the system 100 may be found in commonly assigned U.S. Pat. No. 8,080,060 and U.S. Application Pub. No. 210/0155282, both of which are incorporated by reference in their entirety herein. In these examples, the systems require a sufficient level of vacuum within the medical device vacuum-sealed container, to pull one reactive agent in one portion of the container into a substrate under vacuum in a second portion of the container. The invention of the present disclosure provides visual indication of whether sufficient vacuum has been maintained in the second portion to sufficiently hydrate or seed an implant with a biologic agent. Other devices, including non-medical devices, may also benefit from vacuum loss indication systems as described herein. As noted above, in some instances, flexible packaging may conform to the shape of the rigid inner container over time, making it difficult to discern vacuum loss. By providing visual indication of vacuum loss, an end user may also quickly see whether or not sufficient vacuum has been maintained to ensure sterility of the contents.
Although in the instances described above include use with medical devices, any product packaged in an outer flexible container may benefit from the features of various inventions of the present disclosure. The system for vacuum loss indication may include an optional product container, a flexible outer container with viewing window, and a vacuum loss indicator. The flexible outer container surrounds the optional product container, product, and vacuum loss indicator to maintain a pressure. The vacuum loss indicator is disposed between at least one surface of the flexible outer container and an opposing surface, be it the product contents, product container, or opposing wall of the flexible container. The vacuum loss indicator includes a first position when the indicator is collapsed under the flexible container sidewall at a first vacuum pressure and one or more secondary positions when the vacuum pressure is at or above a pre-determined threshold above the first pressure.
In other features, the system includes a bias member that couples the indicator with the container or contents and biases the indicator member to the second position. The indicator member includes status-indicating surface(s) that are hidden from view when the vacuum indicator is observed through a transparent portion of the flexible container while it is in the first position. When the vacuum loss indicator is in its secondary positions, the previously hidden status-indicating surface(s) becomes visible when the indicator is observed through a transparent portion of the flexible container.
A vacuum loss indicator at minimum includes an outer container, status-indicating surface(s), and a bias member used to provide restoring force. The status-indicating surface is within the loss indicator outer container, and is visible through the semi-transparent portion. The bias member is pushed to a first position under a first level of vacuum and moves to other positions as vacuum is lost. A first portion of the status-indicating surface is visible through the semi-transparent portion of the flexible container in the first position and one or more a secondary portions are visible through the semi-transparent portion of the flexible container in the second position.
Example embodiments of the methods and systems of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only, and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

The invention claimed is:

1. A system for vacuum loss indication, comprising:

a rigid container;

a flexible container surrounding the rigid container to maintain a pressure; and

an indicator member between the rigid container and the flexible container that includes a first position when the pressure is at a first pressure and a second position when the pressure is at a second pressure greater than the first pressure.

2. The system of claim 1, further comprising a bias member that couples the indicator with the rigid container and biases the indicator member to the second position.

3. The system of claim 1, wherein the indicator member includes a visible indicator that is hidden from view through a transparent portion of the flexible container in the first position and visible through the transparent portion in the second position.

4. The system of claim 1, further comprising a vacuum sealed container disposed within a cavity of the rigid container.

5. The system of claim 1, further comprising a receptacle that receives the indicator member, wherein only an upper surface of the indicator member is visible through a transparent portion of the flexible container in the first position.

6. The system of claim 5, wherein at least one side surface of the indicator member is visible through the transparent portion of the flexible container in the second position.

7. A system for vacuum loss indication, comprising:

a rigid inner container that includes a receptacle having an open proximal end and a closed distal end;

a flexible outer container surrounding the inner rigid container and including a semi-transparent portion;

a sliding block within the receptacle that is visible through the semi-transparent portion and includes a pressure indicator; and

a bias mechanism that biases the sliding block to a first position under a first level of vacuum and a second position under a second level of vacuum,

wherein a first portion of the pressure indicator is visible through the semi-transparent portion in the first position and a second portion is visible through the semi-transparent portion in the second position.

8. The system of claim 7, wherein the flexible outer container includes a vacuum pouch.

9. The system of claim 7, wherein the bias mechanism includes a coil spring.

10. The system of claim 7, wherein the rigid inner container further comprises a cavity containing medical device.

11. The system of claim 10, wherein the medical device includes a pre-packaged, vacuum-sealed container.

12. The system of claim 7, wherein the first portion includes a first color and the second portion includes a second color.

13. A system for vacuum loss indication of a medical device container, comprising:

a rigid inner container that includes a receptacle with a closed distal end and an open proximal end;

a cavity within the rigid container containing a medical device;

a flexible outer container that surrounds the rigid inner container and includes a transparent portion disposed adjacent the receptacle;

a sliding block disposed within the receptacle and including a first portion with a first color and a second portion with a second color; and

a spring that couples the sliding block to the distal end of the receptacle;

wherein the flexible outer container compresses the sliding block within the receptacle to obstruct visualization of the second portion when the flexible outer container includes a first pressure and the spring biases the sliding block to permit visualization of the second portion above the open proximal end when the flexible container includes a second pressure greater than the first pressure.