Title:
Credit card-shaped drug delivery system
Kind Code:
A1


Abstract:
A credit card-shaped case is provided that includes first and second layers. Both the first and second layers are generally rigid and have a generally planar outer surface. The first and second layers are attached to one another and configured to provide a recess therebetween. The recess is configured to prevent moisture intrusion therein. At least one medicine or other chemical substance is contained within the recess.



Inventors:
Staggs Jr., William B. (Nashville, TN, US)
Fenelon, Paul J. (Nashville, TN, US)
Staggs, Stephen M. (Nashville, TN, US)
Application Number:
11/127785
Publication Date:
11/16/2006
Filing Date:
05/12/2005
Primary Class:
International Classes:
B65D85/42
View Patent Images:
Related US Applications:
20010027930Two piece packing systemOctober, 2001Key et al.
20080128433INSULATING STORAGE CONTAINERJune, 2008Stauffer et al.
20090301903Packaging Article, A Wrapped Ream of Paper, and MethodsDecember, 2009Andersson et al.
20060264573Ambient curable protective sealantNovember, 2006Bennett et al.
20090301914Light bulb storage apparatusDecember, 2009Kahle
20020144919Box for storing golf ball and practicing puttingOctober, 2002Li-wen
20080230402Authentication and identification device for a collectable objectSeptember, 2008Macor
20060054670Pack with a tear strip and device for production thereofMarch, 2006Focke et al.
20060263404Assembly for the preparation of a medical device having a coating comprising hydrogen peroxideNovember, 2006Nielsen et al.
20050167288Money holderAugust, 2005Sottile
20090200410MODULAR GRINDING CORE AND GRINDING DEVICES INCORPORATING THE SAMEAugust, 2009Griffith et al.



Primary Examiner:
FIDEI, DAVID
Attorney, Agent or Firm:
Miller & Martin PLLC (CHATTANOOGA, TN, US)
Claims:
1. A case for carrying a chemical substance comprising: a first layer being generally rigid and having a generally planar outer surface; a second layer being generally rigid and having a generally planar outer surface, said first and second layers being attached to one another and configured to provide a recess therebetween, said recess configured to prevent moisture intrusion therein; and at least one chemical substance contained in said recess.

2. The case of claim 1, wherein said recess is located in said second layer.

3. The case of claim 1, further comprising a moisture barrier, said moisture barrier at least covering a surface of said recess.

4. The case of claim 3, wherein said moisture barrier is a foil layer.

5. The case of claim 1, wherein said first and second layers are formed from plastic.

6. The case of claim 1, further comprising a first cover generally covering said recess and attached at a perimeter of said recess.

7. The case of claim 6, further comprising a second cover generally covering said recess and attached at a perimeter thereof, said cover disposed between said first cover and said recess and adapted to be more easily breakable than said first cover.

8. The case of claim 6, wherein said first cover is moisture resistant.

9. The case of claim 1, wherein said case has a thickness less than 0.08 inches.

10. The case of claim 1, wherein said case is generally in the shape of a credit card.

11. The case of claim 1, wherein said case includes at least two recesses.

12. The case of claim 11, wherein said recesses include different chemical substances contained therein.

13. The case of claim 1, wherein said chemical substance is an emergency medicine.

14. The case of claim 1, wherein said case includes a list of symptoms, printed thereon, associated with an illness requiring said chemical substance.

15. The case of claim 1, wherein said case includes instructions for usage thereon.

16. The case of claim 1, wherein said recess includes a vapor barrier.

17. The case of claim 1, wherein said recess is sealed around a perimeter thereof.

18. The case of claim 17, wherein said sealed perimeter of said recess is adapted to identify when said sealed perimeter has been broken.

19. The case of claim 18, wherein a chemical reaction occurs when said seal is broken thereby causing a color change of said sealed perimeter.

20. The case of claim 1, further comprising a middle layer disposed between said first and second layers, said middle layer having said recess therein.

21. The case of claim 20, wherein said recess extends completely through said middle layer.

22. The case of claim 20, wherein said recess extends partially through said middle layer.

23. The case of claim 20, wherein said middle layer includes a first side and a second side, each of said first and second sides having at least one of said recesses therein.

24. The case of claim 1, wherein said first layer includes at least one tare strip.

25. The case of claim 24, wherein said second layer includes at least one tare strip.

26. The case of claim 1, wherein said first layer includes at least one tare portion, said tare portion generally aligned with said recess.

27. The case of claim 26, wherein said first layer includes at least two tare strips and said first and second layers include at least two recesses disposed therebetween, each of said tare strips being generally aligned with at least one of said recesses.

28. The case of claim 1, wherein said first and second layers are generally rectangular in shape and have generally similar lengths and widths, said first and second layers being generally aligned with one another and having at least three sides fixedly attached to one another.

29. The case of claim 1, wherein said first layer includes an edge relief portion.

30. The case of claim 1, wherein said first layer includes a recess for receiving said second layer.

31. The case of claim 1, wherein said first layer includes a bendable tab portion disposed along an edge thereof to facilitate removal of the second layer from the first layer.

Description:

FIELD OF THE INVENTION

The present invention relates to medicinal containers, and more particularly to easily portable medicinal containers.

BACKGROUND OF THE INVENTION

Medicines typically do not come in packages that are convenient for carrying on a daily basis. Often medicine packages are bulky bottles or boxes. The packages that are contained within the boxes or other containers typically are not properly shaped or sufficiently rigid to withstand the abuse of being carried in a pocket or wallet on a daily basis. Further, these packages are often not moisture resistant, making them vulnerable to moisture intrusion.

Medicine packages typically do not provide for the dispensing of multiple medications to be taken in conjunction with one another. Particularly, there does not appear to be a convenient way to carry multiple medications that may be required to be taken in conjunction with one another in an emergency situation, such as a heart attack. As a result, there appears to be a need in the art for an improved medicine case that is resilient to many conditions and convenient to carry.

SUMMARY OF THE INVENTION

A medicine case is provided that includes first and second layers. Both the first and second layers are generally rigid and have generally planar outer surfaces. The first and second layers are attached to one another and configured to provide a recess therebetween. This recess is configured to prevent moisture intrusion therein. At least one medicine is contained within the recess.

Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of a first example of a credit card-shaped drug delivery system according to the principles of the present invention;

FIG. 2 is a perspective view of a second example of a credit card-shaped drug delivery system according to the principles of the present invention;

FIG. 3 is a perspective view of a third example of a credit card-shaped drug delivery system according to the principles of the present invention;

FIG. 4 is a plan view of an exemplary credit card-shaped drug delivery system according to the principles of the present invention;

FIG. 5 is a cross-sectional view of the base layer taken across line 5-5 of FIG. 4;

FIG. 6 is a plan view of an exemplary cover layer of the credit card-shaped drug delivery system according to the principles of the present invention; and

FIG. 7 is a perspective view of a wallet-like card carrier for carrying a plurality of credit-card shaped drug delivery cards.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

FIG. 1 shows a first example of a credit card-shaped drug delivery system 10. The credit card-shaped drug deliver system 10 may include a first layer 12 and a second layer 14 fixedly coupled to one another.

The first layer 12 may be generally rectangular and have four side edges 16, 18, 20, 22, resembling the shape of a credit card. The credit card-shaped drug delivery system 10 may be of any thickness that is convenient for carrying, but in the present example the credit card-shaped drug delivery system 10 is preferably less than 0.125 inches thick. Alternatively, the credit card-shaped drug delivery system 10 could be even thinner, having a thickness approximately equal to that of a credit card, approximately 0.02 to 0.08 inches.

The first layer 12 may have generally planar inner and outer surfaces 24, 26. Although the surfaces are generally planar, they may include protrusions, bumps, ridges, indicia, or other textured features not substantially increasing the thickness thereof. A series of tare strips 28, allowing portions of the first layer 12 to be broken and removed from the second layer 14, may also be located on the first layer 12 generally inwardly from side edges 18 and 22. The tare strips 28 may include perforations or a scored line in order to facilitate the breaking away along the tare strips 28. The first layer 12 may be formed from any suitable material, one example being a plastic.

The second layer 14 may have a shape generally similar to the first layer 12, being generally rectangular and having four side edges 30, 32, 34, 36. The second layer 14 may have generally planar outer surface 27 and may also include protrusions, bumps, ridges, indicia or other textured features. The second layer 14 may also include an edge relief portion 38, allowing a user thumb access to the first layer 12 to be independently torn back. The second layer 14 may have a series of recesses 40, 42 contained therein. While two recesses 40, 42 are shown in the present example, it should be understood that any number of recesses may exist. The recesses 40, 42 may have a foil, or some other moisture-proof coating thereon. Medicine or other substance in the form of tablets, wafers, powders or gels can be inserted in the recesses 40, 42 as will be described in greater detail herein. The recesses 40, 42 may also include an easily breakable coating over a top portion thereof, preventing the medicine or other substance from falling or spilling out of the recesses 40, 42. For example, this coating could be a foil coating as commonly found in drug containers. Additional covers 44, 46 are provided over the top of the recesses 40, 42. The second layer 14 may be formed from any suitable material, one example being a plastic.

The covers 44, 46 may be moisture resistant and generally the same shape as the recesses 40, 42, but slightly enlarged to allow a perimeter seal. A tab 48 may extend from each of the covers 44, 46 allowing easy opening of the covers 44, 46. If necessary, the recesses 40, 42 and covers 44, 46 may also include a vapor barrier (not shown). This may be necessary if the recesses 40, 42 contain a non-solid, such as an ointment.

The moisture-resistant coating on the recesses 40, 42 may be integrally molded onto the recesses 40, 42. For example, the moisture-resistant coating may be a foil layer that is placed in a mold before the second layer 14 is molded. When the second layer 14 is molded, the moisture-resistant coating is integrally formed on the recesses 40, 42.

The first and second layers 12, 14 may be bonded to one another around a first side edge 18, 32, a second side edge 20, 34 and a third side edge 22, 36. This bonding may be achieved through any means resulting in the sides being fixedly coupled to one another, such as heat staking, ultrasonic welding or gluing. Alternatively, the fourth side edges 16, 30 of the first and second layers 12, 14 may also be initially bonded to one another.

When the medicine is needed, the first layer 12 may be peeled back by pulling a portion of the first layer 12 proximate the edge relief portion 38 in the second layer 14. The series of tare strips 28 allow the first layer tare portion 50 to be at least partially removed to expose the second layer 14 beneath. Once the second layer 14 is exposed, the user may remove the covers 44, 46, allowing easy access to the medicine contained in the recesses 40, 42. The second layer 14 may optionally include an additional covering that is easily breakable to prevent the medicine from spilling out when the covers 44, 46 are removed.

An alternative credit card-shaped drug delivery system 110 is shown in FIG. 2. The credit card-shaped drug delivery system 110 may include a first layer 112 and a second layer 114 fixedly coupled to one another and is generally similar to the credit card-shaped drug delivery system 10 shown in FIG. 1. However, credit card-shaped drug delivery system 110 allows for multiple dosages to be contained therein. The credit card-shaped drug delivery system 110 may be of any thickness that is convenient for carrying, but in the present example the credit card-shaped drug delivery system 110 is preferably less than 0.125 inches thick. Alternatively, the credit card-shaped drug delivery system 110 could be even thinner, having a thickness approximately equal to that of a credit card, approximately 0.02 to 0.08 inches.

The first layer 112 may be generally rectangular and have four side edges 116, 118, 120, 122, preferably resembling the shape of a credit card. The first layer 112 may have generally planar inner and outer surfaces 124, 126. Although the surfaces are generally planar, they may include protrusions, bumps, ridges, indicia, or other textured features not substantially increasing the thickness thereof. Multiple sets of tare strips 128a-d (including perforations or scoring), allowing first layer tare portions 150a-d to be broken and removed from the second layer 114, may also be located on the first layer 112 generally inwardly from side edges 116 and 120. The first layer 112 may be formed from any suitable material, one example being a plastic.

The second layer 114 may have a shape generally similar to the first layer 112, being generally rectangular and having four side edges 130, 132, 134, 136. The second layer 114 may have a generally planar outer surface 127 and may also include protrusions, bumps, ridges, indicia or other textured features. The second layer 114 may also include a series of edge relief portions 138a-d, allowing the independent access to each of the first layer tare portions 150a-d, making it easier for each to be independently torn back. The second layer 114 may have a series of recesses 140a-d contained therein. While one recess is shown below each of the first layer tare portions 150a-d, it should be understood that any number of recesses may exist. It should also be understood that there may be a lesser or greater number of individual tare portions associated with the various recesses as well. The recesses 140a-d may have a foil, or some other moisture-proof coating thereon. The recesses 140a-d may also include an easily breakable coating over a top portion thereof, preventing the medicine or other chemical substance from falling out of the recesses 140a-d once the covers 144a-d are removed. For example, this coating could be a foil coating commonly found in drug containers. The second layer 114 may be formed from any suitable material, one example being a plastic.

The covers 144a-d may be moisture resistant and generally the same shape as the recesses 140a-d, but slightly enlarged to allow a perimeter seal. A tab 148 may extend from each of the covers 144a-d allowing easy opening of the covers 144a-d. If necessary, the recesses 140a-d and covers 144a-d may also include a vapor barrier (not shown). This may be necessary if the recesses 140a-d contain a non-solid, such as an ointment.

The moisture-resistant coating on the recesses 140a-d may be integrally molded onto the recesses 140a-d. For example, the moisture-resistant coating may be a foil layer that is placed in a mold before the second layer 114 is molded. When the second layer 114 is molded, the moisture-resistant coating is integrally formed on the recesses 140a-d.

The first and second layers 112, 114 may be bonded to one another around a first side edge 120, 134, a second side edge 122, 136 and a third side edge 116, 130. This bonding may be achieved through any means resulting in the sides being fixedly coupled to one another, such as heat staking, ultrasonic welding or gluing. Alternatively, the fourth sides 118, 132 of the first and second layers 112, 114 may also be initially bonded to one another.

When the medicine is needed, the first layer tare portions 150a-d may be selectively peeled back by pulling a portion of the first layer 112 proximate the recesses 138a-d in the second layer 114. The series of tare strips 128a-d allow the first layer 112 to be at least partially removed to expose the second layer 114 beneath. Once the second layer 114 is exposed, the user may remove the covers 144a-d, exposing an additional covering that is easily breakable, allowing easy access to the medicine contained in the recesses 140a-d.

Another alternative credit card-shaped drug deliver system 210 is shown in FIG. 3. The credit card-shaped drug delivery system 210 may generally be the shape and size of a credit card and may include a first layer 212, a middle layer 213 and a second layer 214. The credit card-shaped drug delivery system 210 may be of any thickness that is convenient for carrying, but in the present example the credit card-shaped drug delivery system 210 is preferably less than 0.125 inches thick, although greater thicknesses can be used if so desired. Alternatively, the credit card drug delivery system 210 could be even thinner, having a thickness approximately equal to that of a credit card, approximately 0.02 to 0.08 inches.

The first layer 212 may be generally rectangular, similar to a credit card as stated above, and have four side edges 218, 220, 222, 224. The first layer 212 may have generally planar inner and outer surfaces 223, 225. Although the surfaces are generally planar, they may include protrusions, bumps, ridges, indicia, or other textured features not substantially increasing the thickness thereof. The first layer 212 may have a tare strip feature 226 proximate sides 220, 224. The first layer 212 may be formed from any suitable material, one example being a plastic.

The second layer 214 may be generally similar to the first layer 212. The second layer 214 may have generally planar outer surface 227 and may include protrusions, bumps, ridges, indicia or other textured features. The second layer 214 may include four side edges 228, 230, 232, 234 and have a shape generally similar to that of a credit card as stated above. Side edge 228 may include an edge relief portion 236 providing easy access to side edge 218 of the first layer 212. The second layer 214 may be formed from any suitable material, one example being a plastic.

The middle layer 213 may be generally rectangular and have four side edges 238, 240, 242, 244. The middle layer 213 may also include an edge relief portion 246 generally corresponding with the edge relief portion 236 in the second layer 214. The middle layer 213 may have a series of recesses or openings 248, 250 contained therein. While two recesses are shown in the present example, it should be understood that any number of recesses may exist. It should also be understood that multiple tare portions could be included as shown in FIG. 2. The middle layer 213 may be formed from any suitable material, one example being a plastic.

The recesses 248, 250 may extend completely through the middle layer 213 (as shown) or may only partially extend therethrough (not shown). The middle layer 213 may include a moisture resistant coating on a bottom surface 252 thereof. The moisture resistant coating may extend along the entire bottom surface 252 of the middle layer 213 or may cover only the recesses 248, 250. The moisture resistant coating may be foil or some other suitable material.

A series of covers 256, 258 may be located on the middle layer 213 over the recesses 248, 250. The covers 256, 258 may be moisture resistant. The covers 256, 258 may be generally the same shape as the recesses 248, 250, having a slightly larger size to allow overlap for sealing. The covers 256, 258 may have tabs 260, 262 generally extending from their perimeters to allow easy removal. The recesses 248, 250 may also include an easily breakable coating over a top portion thereof, preventing the medicine or other chemical substance from falling out of the recesses 248, 250 once the covers 256, 258 are removed. For example, this coating could be a foil coating commonly found in drug containers. If necessary, the recesses 248, 250 may also include a vapor barrier (not shown). This may be necessary if the recesses 248, 250 contain a non-solid, such as an ointment.

The moisture-resistant layer 254 may be integrally molded onto the middle layer 213. For example, the moisture-resistant layer 254 may be a foil layer that is placed in a mold before the middle layer 213 is molded. The first, middle and second layers 212, 213, 214 may be bonded to one another around a first side edge 220, 230, 240, a second side edge 222, 232, 242, and a third side edge 224, 234, 244. This bonding may be achieved through any means resulting in the sides being fixedly coupled to one another, such as heat staking, ultrasonic welding or gluing.

When the medicine, or other chemical substance, is needed, the first layer 212 may be peeled back as a result of the tare strips 226. This feature 226 allows the first layer 212 to be at least partially removed to expose the middle layer 213 beneath. Once the middle layer 213 is exposed, the user may remove the first and second sets of covers 256, 258, exposing an additional (optional) covering that is easily breakable, allowing easy access to the medicine or other chemical substance contained in the recesses 248, 250.

While not shown, it should be noted that while the credit card-shaped drug delivery system 210 shows the sides of the middle layer 213 attached to the sides of the first and second layers 212, 214, the middle layer 213 could be free from adhesion with the first and second layers 212, 214. The middle layer 213 could have a width slightly less than the width of the first and second layers 212, 214. The first and second layers could be fixedly attached to one another at the edges 220, 222, 224, 230, 232, 234, providing a recess for housing the middle layer 213 therebetween. This would allow the middle layer to be slidable within the recess between the first and second layers 212, 214. This would make it possible to refill the credit card drug delivery system 210 without the need to replace the first and second layers 212, 214 each time. This could reduce cost and allow for customization of the reusable case.

While the credit card-shaped drug delivery system 10, 110, 210 disclosed in the examples above are shown to be generally the size and shape of a credit card, it should be understood that variations in size and shape are possible. These variations are still considered to be within the scope of the present invention.

The credit card-shaped drug delivery system 10, 110, 210 may also include information printed thereon. This information may include instructions for usage and symptoms associated with illness requiring the drug.

The credit card-shaped drug delivery system 10, 110, 210 may contain drugs for any condition. This may include medications for life threatening illness, non-life threatening illnesses and preventative medications. Some common examples of conditions requiring the credit card drug delivery system 10, 110, 210 may be heart attack symptoms, allergies, poisons, insect bites, animal bites, birth control, hangovers, sleepiness, and other circumstances requiring the use of chemical substances such as sodium hypochloride or other substances used for purifying or killing bacteria contained in water. Examples of medicines and other chemical substances that may be contained in the credit card-shaped drug delivery system 10, 110, 210 are aspirin, nitroglycerin, atropine, epinephrine, migraine medications, asthma medications, antihistamine, birth control pills, and sodium hypochloride. As a result of the numerous applications, each credit card-shaped drug delivery system 10, 110, 210 may contain multiple types of medicines or other chemical substances. One such example may be aspirin and nitroglycerin for heart attack symptoms. Studies have shown that heart attack victims who take aspirin and nitroglycerin at the onset of a heart attack can greatly reduce the severity of the damage incurred due to the heart attack. The credit card-shaped drug delivery system 10, 110, 210 makes it easy for heart attack candidates to always have aspirin and nitroglycerin readily available in a convenient-to-carry package that easily fits into a wallet.

The credit card-shaped drug delivery system 10, 110, 210 may have built-in safety features. For example, an expiration date may be printed thereon. Additionally, there may be a notification of when the seal of the drug containing recess has been broken. For example, the covers 44, 46, 144a-d, 256, 258 may be sealed using a chemical bond that will notify the user when the seal has been broken. Specifically, the seal area may change colors once the seal has been broken. Examples of this type of color changing wrapper are shown in U.S. Pat. No. 5,234,732, which is herein incorporated by reference in its entirety.

While the examples disclose a one-sided card, having access to medicines on one side only, it should be noted that a similar configuration could be used to provide a two-sided card. This would result in an increased drug carrying capacity and allow an extended period for use. The two-sided card could be generally similar to the one-sided card, having a second set of recesses on a side opposite the first set of recesses. The second set of recesses may be offset from the first in order to minimize thickness. The second set of recesses may be covered by a layer similar to the first layer in the various examples explained above.

With reference to FIGS. 4-6, an exemplary credit card-shaped drug delivery system 400 is shown. The credit card-shaped drug delivery system 400 includes a base layer 402 and cover layer 404. The base layer 402, as best shown in FIG. 5, includes an outer flange portion 402A having a thickness T. According to a preferred embodiment, the thickness T is between 0.02 and 0.08 inches, and more preferably, 0.05 inches. The outer dimensions of the credit card-shaped drug delivery system 400 can be approximately between 3.0-3.75 inches by approximately between 1.75 and 2.5 inches in order to fit into a standard wallet, although other shapes and sizes are also possible. Inward from the outer flange portion 402A is a first recessed portion 402B that is designed to receive the cover portion 404. The recessed portion 402B has a thickness approximately equal to the thickness T minus the thickness of the cover portion 404. According to a preferred embodiment, the cover portion 404 has a thickness of approximately 0.015 inches so that the thickness T1 of the recessed portion 402B is approximately 0.035 inches. The base portion 402 further includes a second recessed portion 402C which is further recessed from the first recessed portion 402B approximately equal to the thickness of the cover 408 that covers the medication. The thickness of the cover 408 is approximately 0.005 inches, therefore, the thickness T2 is preferably approximately 0.030 inches. The base portion 402 further includes a third recessed portion 402B which receives the medication or other chemical substance therein and provides a wall thickness T3 that is sufficient to withstand normal forces that might be applied to the credit card-shaped drug delivery system 400. Preferably, the medicine receiving portion has a wall thickness T3 of approximately 0.010 inches. The base layer 402 may include a plurality of integrally formed pins 403 extending from first recessed portion 402B at spaced locations.

The credit card-shaped drug delivery system 400 is preferably assembled by placing the medicine in the third recess portion 402D which may or may not include a vapor barrier on the bottom thereof. The cover 408 is then provided over top of the medicine and recessed in the second recessed portion 402C in which it is adhered or otherwise bonded thereto. Then, the cover 404 is provided in the first recessed portion 402B. The cover 404 can include pin receiving apertures 410 therein for receiving pins 403 for holding and aligning the cover 404 with the base portion 402. The pins 403 preferably have a length greater than a length of the apertures 410. Once the cover 404 is in place within recess portion 402B, the pins 403 can be heat staked in the areas surrounding the apertures 410 to secure the cover 404 to the base portion 402. Alternatively, adhesive could also be applied around the perimeter of the cover 404 or around the first recessed portion 402B in order to adhere the cover 404 to the base portion 402. In the embodiment shown, the base portion 402 includes cut portions 412 defining a break-away tab 414 that facilitate removal of the cover portion 404 from the base portion 402.

As shown in FIG. 7, a wallet 300 containing a plurality of credit card-shaped drug delivery systems 10, 110, 210 could also be provided. For example, the wallet may include numerous pockets 302 for receiving card-shaped drug delivery systems 10, 110, 210 bound together in an easy to carry wallet 300 for dispensing to patients.

The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.