The present invention generally relates to medication packages and, more particularly, relates to child resistant medication packages that incorporate a protective shielding component.
There is a continued need for medication packages that are child resistant and specifically resistant to children that bite or otherwise use their fingers to gain access to potentially harmful medication. In addition, there is also a desire to have medication packages that allow the average adult to see the medication contained in the package but retain an acceptable or aesthetic visual appearance after multiple medicaments have been removed from the package. There is also a need to make this type of package economical to manufacture.
Over the years, a wide variety of disposable medication packages have been suggested which are accessible through a variety of folding, stripping, rupturing, peeling, and/or tearing procedures. These packages have typically been formed of transparent top layers which are sealed or otherwise bonded to backing layers in a manner which provides a cavity, pouch or “blister” in which the medicament resides. The top and backing layers may be formed of flexible packaging materials, rigid thermoformable plastic materials, foil, paper, laminates, or combinations thereof. Medicament cavities formed between such layers have been accessed by tearing into them from an edge of the package, which tearing may or may not be facilitated through the provision of a starting notch or slit, or by simply pushing on the blister until the medicament breaks through the backing layer. Alternatively, these cavities may be accessed by stripping a backing layer from the package to expose the cavity, or to expose a push-through underlayer. In other instances, the backing layer is made of foil that can be ruptured when the medication in the blister is pushed against the backing layer. Generally, these packages are tamper evident, but typically not child resistant. Other medication packages require some form of peeling of the bottom surface from the top surface to get access to the medication.
Child resistant medication packages that have blisters have been in use for some time, however, as is too often the case, “child resistant” simply means that many people who do not have sufficient motor skills, finger strength, or whose hands shake are not able to easily gain access to the medicament in such packages. Children, however, do not generally limit themselves to the use of their fingers to open containers or packages. Usually after failing to open an object, children readily resort to more destructive methods to overcome child resistant features. For smaller packages, or for features that are accessible, for example, a blister containing a pill, children will use their teeth to destroy a protective barrier. This can be a problem especially when the protective, child-resistant features of the package are small enough to allow a child to place the protective barrier in their mouth.
There is a need for a medication package that is relatively easy to open for an adult, but still child resistant. Further, the package must remain visually appealing after several medicaments have been removed. And furthermore, the package must be easy to manufacture without having to introduce custom machinery, so that the package remains economical. The present invention has accomplished these needs by creating a medication package that does not require fine motor skill functions, such as pinching and peeling. The present invention is relatively easy to open by application of substantially orthogonal pressure on the medicament blister, retains its visual appeal after multiple uses, and yet will substantially fend off direct biting assaults made by children.
In its most general configuration, the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices. In its most general sense, the present invention overcomes the shortcomings and limitations of the prior art in any of a number of generally effective configurations.
The shielded child resistant medicament package of the present invention is designed for housing a solid medicament. The package includes a blister portion sandwiched between a backing substrate and blister shield. The package may also include a dispensing substrate and a retaining substrate. The arrangement of the three primary components is unique and requires application of a force on the blister portion to access the medicament. The blister shield prevents access to the blister portion other than by pressure on the top of the blister portion. Consequently, any attempts to pick at or bite the blister portion from the side are thwarted by the blister shield. A child cannot bite or pinch the blister containing the medicament.
The blister portion contains a base layer and a blister layer. The blister layer is formed to include an article receiving blister designed for holding the medicament. Generally, at least five percent of the surface area of a base layer interior surface is joined to a blister layer interior surface thereby sealing the medicament in the article receiving blister. The area of the blister layer that is formed into the article receiving blister is not joined to the base layer.
The blister shield is formed with a blister well. The blister well is generally shaped to cooperate with the article receiving blister. The blister well is positioned so that it prevents access to the sides of the article receiving blister but provides access to the top of the article receiving blister. Therefore, application of pressure to the top of the article receiving blister is required to remove the medicament.
The backing substrate is formed to have an article dispensing region. The article dispensing region is configured to cooperate with the blister portion. In other words, the article receiving blister and the article dispensing region must generally align such that when the medicament is ejected from the article receiving blister the medicament may pass through the article dispensing region.
The assembly and orientation of the various elements of the package imparts the desired functionality to achieve the child resistance, aesthetics, and operation necessary to open the package. To dispense the medicament from the package requires application of a substantially orthogonal force to the exposed portion of the article receiving blister. Generally, the force will be applied by a tip of a human digit, most likely the thumb. The force is applied from the blister shield side of the package. The shield protects the sides of the article receiving blister. The blister shield may be solid or may be formed as a shell with supporting contact points.
Thus, there is disclosed a shielded child resistant medicament package (10) for housing a medicament (M), comprising:
(a) a blister portion having:
(b) a blister shield having a blister shield thickness, a blister shield support bearing edge, a blister shield top surface, and a blister shield bottom surface, wherein the blister shield is formed with a blister well having a well interior perimeter such that the blister well cooperates with the article receiving blister;
(c) a backing substrate having a backing substrate perimeter, a backing substrate interior surface, and a backing substrate exterior surface, wherein the backing substrate is formed to have an article dispensing region having an article dispensing region perimeter, wherein the article dispensing region is configured to cooperate with the blister portion; and
(d) wherein the blister portion is located between the blister shield and the backing substrate such that the article receiving blister, the blister well, and the article dispensing region substantially align and the blister well cooperates with the article receiving blister to shield, in part, the article receiving blister from the application of substantially lateral forces thereby preventing access to the medicament via compromise of the article receiving blister and requiring application of a substantially orthogonal force to the article receiving blister to result in the medicament breaking through the base layer, and passing out of the article dispensing region.
Thus, there is further disclosed a shielded child resistant medicament package for housing a medicament, comprising:
(a) a blister portion having:
(b) a dispensing substrate having a dispensing substrate perimeter, a dispensing substrate interior surface, a dispensing substrate exterior surface, and the dispensing substrate is formed to have a dispensing substrate blister receiver;
(c) a blister shield having a blister shield support bearing edge, a blister shield top surface, a blister shield bottom surface, a blister well, and a blister shield height; wherein
(d) a backing substrate having a backing substrate perimeter, a backing substrate interior surface, and a backing substrate exterior surface, wherein the backing substrate is formed to have an article dispensing region having an article dispensing region perimeter, wherein the article dispensing region is configured to cooperate with the blister portion;
(e) a retaining substrate having a retaining substrate interior surface, a retaining substrate exterior surface, and a retaining substrate blister receiver that is designed to cooperate with the blister portion; and
(f) wherein the blister portion lies between the backing substrate and the retaining substrate with the blister shield held in place by the dispensing substrate, and wherein the article receiving blister, the blister well, and the article dispensing region substantially align and the blister well cooperates with the article receiving blister to shield, in part, the article receiving blister fro the application of substantially lateral forces thereby preventing access to the medicament via compromise of the article receiving blister and requiring application of a substantially orthogonal force to the article receiving blister to result in the medicament breaking through the base layer, and passing out of the article dispensing region.
Various objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
Without limiting the scope of the present invention as claimed below and referring now to the drawings and figures:
The child resistant medicament package of the instant invention provides a significant advance in the state of the art. The preferred embodiments of the apparatus accomplish this by new and novel arrangements of elements that are configured in unique and novel ways and which demonstrate previously unavailable but desirable capabilities. The detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
The shielded child resistant medicament package (10) of the present invention is designed for housing a solid medicament (M) regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, etc. As seen in
First, the blister portion (100) contains a base layer (110) and a blister layer (150). The base layer (110) has a base layer perimeter (120), a base layer exterior surface, and a base layer interior surface (140), labeled in
The blister layer (150) is preferably made of pharmaceutical grade PVC or other thermoplastic material, such as polypropylene, polyethylene, styrene, cold-formed foil, or other suitable materials for packaging. The article receiving blister (190) may be formed by a thermoforming process in which the blister layer (150) material is stretched into a cavity with a vacuum technique to form the blister portion. In a preferred embodiment, a sheet of suitable material for the blister layer (150) is exposed to heating elements for a pre-determined time. This sheet is then trapped in a forming station where it is subjected to both vacuum and pressure. During this process, the material may also be mechanically assisted into the blister cavity via a matched metal plug to form the article receiving blister (190). In another embodiment, the article receiving blister (190) may be formed by using cold-formed foil and cold-form packaging processes. The base layer (110) may be comprised of one or more separate layers of material, such as foil and polyester or other suitable foils. The base layer (110) is typically comprised of multiple layers, but it could be made of any material.
Referring again to
Second, referring to
The blister shield (300) may be a sheet of material formed in any desired shape or it may be a solid layer, as shown in
The blister shield height (360) is generally from 25% to 250% of the height of the blister height (198). However, in one embodiment, the blister shield height (360) may be from 75% to 125% of the height of the blister height (198) and in another embodiment, the blister shield height (360) may be substantially the same as the blister height (198), as shown in
Third, with reference to
The article dispensing region (440) has an article dispensing region perimeter (442) and is configured to cooperate with the blister portion (100), as seen in
Alternatively, the article dispensing region (440) may be an integral portion of the backing substrate (400) having a separation line (444), seen in
The assembly and orientation of the various elements of the package (10) imparts the desired functionality and child resistance of the shielded child resistant medicament package (10). The general assembly process is illustrated in
The blister portion (100) is located between the backing substrate (400) and the blister shield (300). In fact, the blister portion blister layer (150) is adjacent the blister shield rear surface (320) and the base layer exterior surface is adjacent to the backing substrate interior surface (410). As seen in
Once the blister portion (100) is in place, the blister shield (300) is brought into contact with the blister portion (100). In the embodiment of
In an embodiment of the invention shown in
A further embodiment, seen in
As shown in
In the embodiment of
As with the backing substrate (400) and the blister shield (300), in one particular embodiment the dispensing substrate (200) is comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by a human finger. The material may be paper, or other fiber product, plastic, foil, or composite.
In another embodiment, the shielded child resistant medicament package (10) includes a retaining substrate (500), as shown in
When the package (10) is assembled, as shown in
Now, dispensing the medicament (M) from the package (10) requires application of a substantially orthogonal force within the blister shield well (340) to the article receiving blister end wall (194) resulting in pressure being exerted to the medicament (M) so that the base layer (110) ruptures and medicament (M) passes through the backing substrate dispensing region (440). Generally, the substantially orthogonal force will be applied by a tip of a human digit, most likely the thumb.
The figures illustrate that each of these components may be separate and distinct elements that are joined together to create the shielded child resistant medicament package (10). However, the continuous substrate embodiments illustrated in
It should be noted that although the figures of the present application illustrate embodiments of the package (10) having six article receiving blisters (190), and therefore six blister wells (340), and six article dispensing regions (440), the present invention need only incorporate one of each of the previously listed elements, yet may incorporate hundreds of such elements.
Numerous alterations, modifications, and variations of the preferred embodiments disclosed herein will be apparent to those skilled in the art and they are all anticipated and contemplated to be within the spirit and scope of the instant invention. For example, although specific embodiments have been described in detail, those with skill in the art will understand that the preceding embodiments and variations can be modified to incorporate various types of substitute and or additional or alternative materials, relative arrangement of elements, and dimensional configurations. Accordingly, even though only few variations of the present invention are described herein, it is to be understood that the practice of such additional modifications and variations and the equivalents thereof, are within the spirit and scope of the invention as defined in the following claims.
The shielded child resistant medicament package answers a long felt need for a novel package that is resistant to children, particularly those children that bite or those that have tenacious destructive character. In addition, there is a need for a package that retains its original aesthetic appeal after multiple medicaments have been removed from the package. The package is for use with small or large medicaments of various shapes. The present invention discloses a package that implements requiring the application of a substantially orthogonal force before the medicament can be dispensed, thereby avoiding some of the inherent problems of medication packages that use peeling to be opened. The package of the present invention is relatively easy for an adult to manipulate, but not easy for a child to access a medicament within the package.
Number | Name | Date | Kind |
---|---|---|---|
6021901 | Wolfe | Feb 2000 | A |
6036018 | Harrold | Mar 2000 | A |
6098835 | DeJonge | Aug 2000 | A |
6375956 | Hermelin et al. | Apr 2002 | B1 |
6460693 | Harrold | Oct 2002 | B1 |
6529446 | de la Huerga | Mar 2003 | B1 |
6726053 | Harrold | Apr 2004 | B1 |
6805258 | Cross | Oct 2004 | B2 |
6854618 | Harrold | Feb 2005 | B2 |
6978894 | Mundt | Dec 2005 | B2 |
6988618 | DeJonge | Jan 2006 | B2 |
7000769 | Killinger | Feb 2006 | B2 |
20050211597 | Penfold et al. | Sep 2005 | A1 |
20060102512 | Lo Duca | May 2006 | A1 |
20060118452 | Gattefosse et al. | Jun 2006 | A1 |
Number | Date | Country | |
---|---|---|---|
20070151893 A1 | Jul 2007 | US |