Patent Application
20060207911
The present invention relates generally to an emergency medical treatment system which can be conveniently carried on the person, and more particularly it relates to a credit card-sized container having a thin wafer drug dose or doses therein for use in emergencies or treatment of urgent medical conditions.
There are a number of medical emergencies which require immediate treatment in order to avoid physical injury or even death. For example, at the onset of a heart attack, taking an aspirin is one of the possible treatments. In the Dec. 2, 2004 issue of NEJM, Alboni et al. reported the efficacy of self-medication for recent onset atrial fibrillation using a “Pill-in-the-Pocket” (of flecainide or propafenone). Likewise, when experiencing angina pectoris attacks, treatment with nitroglycerin (glyceryl trinitrate) is recommended. Use of epinephrine in the treatment of anaphylaxis may be effective to relieve the symptoms. In chemical warfare, victims exposed to nerve gas *require immediate treatment with atropine.
While the medical emergencies just mentioned are potentially life threatening, a number of other medical emergencies which while not life threatening, still require rapid treatment to avoid discomfort or achieve the sought-after effect. For example, antacids are used for quick relief of indigestion, heart-burn and acid reflux; paregoric, esdifan, Imodium and other treatments of chronic diarrhea usually give relief within 30 minutes, there are anxiety (Atavan and Valium) and migraine headache (Zomig, Imitrex, and Maxalt) treatments which are often urgently needed by those suffering such ailments and even the treatment of male impotency can be considered a medical emergency in the context of the present invention.
But, most people do not know when they are going to require such emergency medical treatment and, accordingly, may not have a supply of the treatment drug on their person or otherwise readily available. And, even if they do, many of the existing treatment systems, such an injectable form of epinephrine or atropine, are cumbersome and can not conveniently be carried on the person. Even a pill-in-the-pocket requires vigilance to make sure there is in fact a pill in the pocket at all times. Besides, with a pill, which disintegrates and releases the active substance in the stomach, the onset of action of the pharmaceutical product as a rule occurs only with a considerable delay of time.
Accordingly, the need exists for a convenient medical treatment system which can be used in such emergency situations.
The present invention meets that need by providing an emergency medical treatment system which can be conveniently carried on the person. Thus, a thin wafer drug dose or doses can be placed in a credit card-sized container which can be carried in the billfold or wallet or anywhere else that a credit-card might be carried by a person. Film-shaped or wafer shaped preparations having a relatively small thickness, compared to the surface area, results in a short diffusion path when applied to the oral mucosa. This leads to a quick release of the active substance, which can be rapidly absorbed through the oral mucosa. Furthermore, the possibility of taking the dosage form in a discreet manner, without the aid of a liquid, is an advantage of a thin wafer drug. A wafer in the wallet more likely assures availability of the treatment at the time of emergency than other treatment forms such as pills or syringes
The container for the wafer drug dose may be made of thin (about 0.05 to about 4.4 mm) sheets of plastic, metal, foil, metalized plastic foil or other material designed to contain drugs effectively. The drug dose may be a wafer of any size and shape which will fit into the credit card-sized container. For example, the wafer may also be of a thickness from about 0.05 to about 3.5 mm.
The drug dose can be aspirin, nitroglycerin, epinephrine, atropine, a phosphodiesterase 5 inhibitor such as sildefanil (Viagra™), an antacid, antidiarrhea, antianxiety, antimigraine or any other drug which can be produced in the disclosed wafer form at a dosage level sufficient to treat the medical condition for which treatment is sought.
With the present medical treatment system a drug dose can conveniently be carried on the person for use in any instance when immediate treatment is desirable ranging from the need to treat for exposure to nerve gas to the desire for rapid sexual stimulation for sexual spontaneity.
A typical credit card is approximately 3⅜″ by 2⅛″ and around 0.76 mm thick and is designed to fit into pockets in a billfold or wallet. A thin container of the same or similar size may also be conveniently carried in a billfold, wallet or anywhere else a credit card might be carried. Generally the container should be within the range of about 0.1 to about 4.5 mm thick in order to fit into a billfold or wallet.
Such a container 10 can be made of two thin sheets 12, 121 of rigid, semirigid or flexible plastic, metal, foil, metalized plastic foil, paperboard or any other material which can be sealed together around the periphery or elsewhere, with a thin wafer drug 11 in-between. In such an instance a tear strip, tear line, break line 13, or other means for rapidly opening the container may be provided so that the thin wafer drug may be easily accessed as shown in
The plastic may be thermoplastic or thermosetting, such as vinyl, polycarbonate, polystyrene, polyester, polyolefin, polyamide, and other known materials. A vinyl plastic is preferred and polyvinylchloride is the preferred vinyl plastic.
Polyvinylchloride (vinyl) is a thermoplastic polymer having an average molecular weight in the range of about 60,000 to about 150,000 g/mole. Vinyl is typically available as a white powder which can be converted into sheets or films. Vinyl is sold by various manufacturers under a number of trademarks, such as “GEON” resins by B. F. Goodrich Chemical Co. The vinyl employed in carrying out the teachings of this invention is of the type typically used to prepare films and sheets. Generally, such vinyl has an inherent viscosity in the range of about 0.70 to about 1.30, as determined by ASTM Method D-1243. To impart flexibility to the vinyl, plasticizer is added. The amount of plasticizer added affects the tensile and elastic properties of the vinyl sheet and determines whether the sheet is flexible, semi-rigid or rigid.
Alternatively, a paperboard material may be used for one or both of the two sheets making up the container. Paperboards such as the following are acceptable paperboards: Clay Coated News Back, Solid Belach Sulphate, Double White Chip Board, Bending Chip, Thermo Mechanically Pulped (TMP), recognizable by those skilled in the art, have been found to be suitable materials.
Paperboard may be a preferred material to use for temperature sensitive drugs because it can have insulating features to protect against cold or body heat.
Whether plastic, paperboard, or any other materials mentioned, each sheet of the container should range in thickness from about 0.05 mm to about 4.4 mm. Preferably the sheets are of about the same thickness in the range of 0.3 to 2.25 mm thick.
As shown in
Another embodiment is shown in
It is also an embodiment of the present invention to have an openable/reclosable container which can be refilled rather than a one-time-use one of the type just described. An example of such a openable/reclosable container is shown in
Each of the protection sheets 17 has a first or fixed portion 19 and a second or hinged portion 20. Hinges 21 connecting each of the hinged portions 20 to the fixed portions 19 are preferably living hinges but could comprise other hinge or pivoting means. A polypropylene living hinge has a life of over 5,000 cycles. The hinges 21 must be located such that the hinged portions 20 make up substantially at least one half of the protection sheets 17. Preferably, the hinges 21 are parallel to each other and pass through the centerline of the wafer drug 11 or at the median of the protection sheets 17. It is also possible for the parallel living hinges 21 to be off the median of the protection sheets 17.
The ring 18 includes a first or fixed portion 23, a second or outer hinged portion 24, and a third or inner hinged portion 25. The ring fixed portion 23 extends at right angles between the fixed portions 19 of the protection sheets 17 along an outer periphery of the protection sheets 17. The ring outer hinged portion 24 inwardly extends at a right angle from one of the protection sheet hinged portions 20 along an outer periphery of the protection sheet hinged portion 20. The ring inner hinged portion 25 inwardly extends at a right angle from the other of the protection sheet hinged portions 20 along a diameter slightly less than a diameter of the ring out hinged portion 24. The ring outer hinged portion 24 is concentric with and overlaps the ring inner hinged portion 25 when the protection sheet hinged portions 20 are closed. Preferably, a friction fit between the ring outer and inner hinged portions 24, 25 locks them together when the protection sheets 20 are closed. It will be noted that other suitable locking means could be utilized.
While
The container 10 may be transparent, translucent, metallic, or colored. One or more surfaces of the container 10 may be printed with trademarks, logos, instructions, medical information, bar codes, or other graphics and indicia. For example, a container 10 for carrying a drug, such as aspirin, to be used at the time of a heart attack could have instructions printed on one surface of the container indicating how the drug is to be taken, telling the user to call 911 or other emergency numbers, advising that they get to a hospital as soon as possible, etc. Another surface of the container could list heart attack warning signs such as the symptoms of chest discomfort, shortness of breath, pain in the shoulder, arms, back, neck, jaw or stomach, and other known symptoms. Medical information such as listing high risk activities could also be included.
Any drug which can be made in solid (either rigid, semi-rigid or flexible) wafer form in a size which will fit in the container 10 and still have an effective dosage may be used. The wafer 11 may be up to about 3.5″ in diameter if round and up to about 3.5 mm thick. Multiple wafers of a smaller size may be packaged in the container. The wafer may be round, as shown in the Figures, or may be oval, square, or other shape. For example, one suspects that the new thin wafer form of Viagra™ which Pfizer is reportedly working on will be diamond shaped. As long as it is of a size which will fit into the container, it may be used in the present emergency medical treatment system. Thus, it is possible to have a 0.05 to 2.5 mm thick wafer 11 sandwiched between two 0.05 to 4.4 mm thick sheets of plastic or metal 12, 121, and obtain an overall thickness for the container of about 0.6 to 4.5 mm. Than can be done, for example, even with a relatively thick wafer or wafers and relatively thick sides of the container by forming hollowed-out (reduced thickness) areas in one or both of the plastic or metal sheets 12, 121, into which the wafer or wafers will fit. Even with a relatively thin wafer 11 or wafers and relatively thin sheets of plastic or metal is still possible to have a container which is overall rigid or semi-rigid (protecting the wafer from crumbling) and which will conveniently fit into a billfold or wallet.
Likewise, as mentioned a more flexible container may also be used with sides made of plastic, foil or metalized plastic foil. While such materials may not protect the wafer or wafers as well, even some breakage or crumbling of the wafer can be tolerated in this instance since the foil like container when torn open simply becomes a pouch from which a crumbled wafer can be poured and consumed.
As mentioned the drug dose can be aspirin, nitroglycerine epinephrine, atropine, a phosphodiesterose 5 inhibitor, an antacid, antidiarrhea, antiaxiety, antimigraine or other drugs. United States Published Patent Application 20050163830, published Jul. 28, 2005, the disclosure of which is hereby incorporated by reference, indicates that the following drugs can be administered in wafer form:
As disclosed in 20050163830, other substance suitable as active agents in wafer drug doses are contained in the following classes or groups:
Any of these wafer drug doses may be used in the present invention. In addition as disclosed in 20050163830, to support the active substance uptake via the oral mucosa, permeation enhancers and/or blood flow enhancers may be added to the active substance in the wafer. The matrix materials used in the wafers and the method of waferizing may be as disclosed in 20050163830 or as otherwise known in the art.
The recommended dose of aspirin to take at the onset of a heart attack is a 325 mg pill. While no wafer forms of 325 mg of aspirin are presently available, it is possible to produce a 325 mg wafer of aspirin in a size and shape which will fit into a container of the type described.
The recommended dose of nitroglycerin (glyceryl trinitrate) tablets to take sublingually to treat angina pectoris is 0.3 mg, with instructions to use up to three tablets if need be. Again while no wafer forms of nitroglycerin are known, it is possible to produce a 0.3 mg wafer of nitroglycerin, in a size an shape where multiple ones can be fit into a container of the type described. In this instance a container of three such wafers might be best suited for the angina sufferer.
It has been reported that administration of sublingual epinephrine by wafer is an alternative to intramuscular administration in the treatment of anaphylaxis. See, Curr Opin Allergy Clin Immural. 2003 August § 3(4): 313-8. Carrying a wafer of epinephrine in a container as described is more convenient than carrying an EpiPen and should be more acceptable to patients.
Atropine—containing gelatin wafers were also used in the past in the treatment of chemical warfare. See, www.worldpharmaweb.com/ddcr/out04/article1. Today, oral tablets of atropine (atropine sulfate oral) are used to treat irritable bowl syndrome and as an antidote to poisoning with certain pesticides. Atropine's use to treat victims's exposed to nerve gas may be essential for the victim's survival. With the present invention oral atropine in wafer form can be carried on the person by those having irritable bowl syndrome, or those in danger of pesticides or even nerve gas poisoning.
Chronic diarrhea, Irritable Bowl Syndrome and Crohn's disease keep many people at home. Treatments such as esdifan, Imodium, and even paregoric can be made in solid wafer form and placed in a credit-card-sized container of the type described herein, giving a mobility choice to these suffering from such medical problems.
While indigestion, heart burn and acid reflux are not usually the type of ailments which limit travel or threaten life, the discomfort caused can be considered a medical urgency. Many antacids and/or antigas treatments already come in chewable tablet form and some such as Mylanta, come in lozenge form. Making them in wafer form sized to fit into a credit-card-sized container provides for a convenient way to treat such medical conditions.
It is also an embodiment of the present invention to provide a treatment for male impotency. As mentioned above, it has been reported that Pfizer is developing a thin wafer form of Viagra which would allow the patient to let it absorb very quickly on the tongue thereby increasing the likelihood of sexual spontaneity. See, www.Viagra-global.com Similar drugs for the treatment of sexual dysfunctions can also be made in wafer form. The ability to carry such a wafer in the patient's billfold in a credit-card size container can only further enhance sexual spontaneity.
While the above-enumerated medical treatments clearly demonstrates a need for convenient carrying case of the type disclosed herein, there are numerous other emergency medical treatments which would benefit from a system such as the present one which allows for the patient to carry a thin-waver drug dose on the person.
Priority is claimed to Provisional Patent Application 60/661,860 filed Mar. 15, 2005.
| Number | Date | Country | |
|---|---|---|---|
| 60661860 | Mar 2005 | US |
