Special receptacle or package – For ampule – capsule – pellet – or granule – Structure for 'press-out' of content unit
Reexamination Certificate
1997-07-14
2003-05-20
Luong, Shian (Department: 3728)
Special receptacle or package
For ampule, capsule, pellet, or granule
Structure for 'press-out' of content unit
C206S534100, C206S459500
Reexamination Certificate
active
06564945
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the prescription medical treatment for sinusitis, more specifically, to a medicinal package that improves compliance with the treatment regimen prescribed for sinusitis.
2. The Prior Art
Sinusitis is a common disorder affecting an estimated 10% of the United States population and affecting all age groups, including children and the elderly. The problem is increasing in prevalence and in 1994, sinusitis accounted for 25 million office visits to physicians in the United States. Sinusitis can be defined as an inflammation of the paranasal sinuses which manifests as a purulent (infected) nasal discharge, nasal congestion, pain in the sinus areas (cheeks, forehead, around eyes, sides of nose), which may be associated with fever, headache, dental pain, earache, post-nasal discharge, cough, sore throat, conjunctival inflammation, foul breath, and olfactory loss. Its temporal manifestations vary from an acute illness of less than three weeks, to recurring episodes, to an unremitting chronic condition. Complications of inadequately treated sinusitis, in addition to chronicity, can be grave because of the proximity of the sinuses to the bony walls enclosing the eyes (orbits) and brain, and include orbital celulitis, optic neuritis, cavernous sinus thrombosis, epidural and subdural infection, meningitis, cerebritis, brain abscess, blindness, and even death.
The management of sinusitis is predicated upon what is known of the pathophysiology of this disorder. The paranasal sinuses consist of a series of bony pouches adjacent to the nasal cavity in the frontal, maxillary, ethmoid and sphenoid regions, which are lined by pseudostratified, ciliated epithelium. Mucous is produced by epithelial goblet cells and submucosal seromucous glands. The blanket of mucous covering the epithelial surface of the sinuses is moved in an orderly fashion by cilia towards natural ostea which lead into the nasal cavity, thereby allowing constant drainage of the sinuses. When the flow of mucous from the sinuses is interrupted, the retained secretions become thickened, the adjacent mucous membranes become inflamed and both mucous and sinus membranes are subject to infection.
Pharmacotherapy for sinusitis is therefore directed at:
(1) reestablishing patency of the sinus ostea (openings),
(2) reestablishing the orderly flow of mucous, and (3) treating the infection. These three objectives conventionally require multiple prescriptions of individual medications, with a typical regimen including: (1) an oral decongestant to shrink the swelling of the sinus membranes thereby opening the sinus exit pathway, (2) an expectorant to increase respiratory tract fluid secretions, reduce their viscosity, and increase the efficacy of the mucociliary mechanism and facilitate mucous flow, and (3) an antibiotic to treat the infection.
The choice of medications and their use together are dependent on numerous considerations besides the mechanism of action and risks of the individual medications. These considerations include absorption, time of onset after dosing, rate of elimination, duration of action after dosing, therapeutic effect by virtue of combination, and side effects by virtue of combination. Medication error and misuse due to a multiplicity of medications and modalities pose an additional risk. Medical and pharmaceutical expertise is clearly required to formulate a treatment regime utilizing a combination of medications and appropriate instructions for use by a lay individuals affected by sinusitis.
Success of such a treatment regimen is contingent upon compliance for a 10-14 day period for acute sinusitis and a 3-8 week period in children and individuals with chronic sinusitis. Previous compliance studies have demonstrated three important considerations which adversely affect compliance: (1) increased complexity of the treatment regimen, (2) poor patient understanding of the treatment rationale, and (3) difficulty of use. Indeed, the multiplicity of medications necessary for sinusitis treatment increases the complexity of the regimen, patients may not fully understand the benefit of each component, and the convention of multiple containers and separate instructions for each component make complying with the regimen more difficult.
United States health care experts conservatively estimate that half of the 1.8 billion prescription medications dispensed yearly are not taken as prescribed. Because of its potentially negative consequences, many consider lack of compliance with treatment regimens to be one of the most serious problems facing health care today. The multiplicity of medications necessary for effective sinusitis treatment makes it especially susceptible to non-compliance.
Solutions to the compliance problem have been put forth by others. Typical of such solutions is the compartmented pillbox, where the medications are stored in compartments representing times of the day and different days. The major shortcoming of the compartmented pillbox is that the patient still receives the medications in separate containers and then must sort the various medications and store them in the proper compartments in the pillbox. This can be a complex and difficult task, especially when the medications are similar in appearance. And there is no guarantee that the medications will be sorted and stored correctly.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a means for increasing compliance with medication regimens for treating sinusitis.
Another objective is to provide a sinusitis patient with a unified, understandable, and organized treatment regimen for sinusitis.
A further object is to minimize complexity and facilitate ease of use of a sinusitis treatment regimen.
The preferred embodiments of the present invention comprise a multiplicity of medications for sinusitis physically arranged so as to simplify their use, functional indicia and instructions for coordinating the medications together as a regimen, and unification of these elements within a pharmaceutical dispensing assemblage.
With the present invention, all of the medications for the treatment regimen are prepackaged into a single prescription package for the patient. The patient only deals with a single package, rather than the multiplicity of packages of the prior treatment regimens. The medication is organized into event modules associated with daily events at which the medication is taken. The event may be a time of day or an activity that is performed during the day. Indicia representing the events associated with the event modules lead the patient clearly through the treatment regimen over its full time period, leading to a greater degree of compliance with the regimen and a greater probability that the treatment will be successfully completed.
The medication dosages are stored in either blister packs or pouches. The blister pack includes a clear plastic sheet with pockets for the dosages and a rupturable or pealable cover for retaining the dosages in their pockets until manually removed. The pouch is a bag composed of thin sheets of plastic or foil and is typically opened by tearing. The present invention can be used with many physical forms of medication, but the preferred forms are those that are most easily taken, such as tablets, capsules, and liquid-gels.
There are two basic preferred embodiments of the present invention, the box embodiment and the card embodiment. The box embodiment includes a box and a plurality of event modules. Each event module is either a blister pack or a pouch and is identified by an event indicia. A set of one day's worth of event modules may be physically combined into a day group. The event modules are organized within the box to present the treatment regimen in a logical progression. In one form, the box has dividers that define compartments, where all of the event modules for one event reside within one associated compartment. In another form, the box is tall, with a slot on one side at the bottom through which
Weinstein Alan M.
Weinstein Robert E.
Deleault, Esq. Robert R.
Luong Shian
Mesmer & Deleault, PLLC
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