Devices for presenting airborne materials to the nose

Incremental printing of symbolic information – Ink jet – Combined

Reexamination Certificate

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C604S028000, C424S001130, C128S203110

Reexamination Certificate

active

06325475

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to the use of ink-jet technology to microdispense airborne materials into an individual's airspace for inhalation or sniffing.
2. Description of the Related Art
A. Purpose of the Invention
Nasal delivery of airborne materials is a vital input pathway to any organism, including human beings. Three aspects of nasal delivery are important: (1) Olfactory sensory cells have axons going directly into the central nervous system, and materials introduced into their cytoplasm via transmembrane uptake in the airway therefore have direct access to the “brain” side of the “blood-brain-barrier,” via anterograde transport within the cells; (2) inhalation is the most direct route of drug delivery to the brain, because the blood returning from the lungs goes directly (via the right atrium and ventricle) to the ascending aorta, delivering an oxygen-rich (and drug-rich) bolus of blood to the brain; (3) the olfactory sense is of unique importance in controlling behavior, including the behaviors of eating, drinking, and vital social behaviors such as bonding, reproduction, and aggression.
For all three of the purposes described above, the precise, digital, interactive, controlled delivery of airborne materials into the nasal airways by solid-state chip-based ink-jet dispensing technology would be a vital and powerful new technique.
Another purpose of the invention is to deliver fragrances into the personal airspace and/or inspired airstream of people engaged in various kinds of entertainment, training or simulation using virtual reality (VR). VR has become a premiere tool for training and performance testing. The power of VR techniques, however, depends heavily upon the illusion of “being there,” or a sense of “presence.” When the sense of presence is strong and a subject is deeply immersed in the illusory environment, the subject begins to feel, act and think as if the situation were real. In the case of synthetic battlefield simulation and training, odors are often the very cues that a soldier/trainee needs to recognize in the emergency situations for which VR training and simulation is most useful. Indeed, some efforts have been made to add smells like leaking jet fuel and melting electrical wires to pilot and firefighter VR training. Direct digital control of odor presentation would be an asset in the VR application.
B. Related Art
i. Alternative Methods of Drug Delivery
Drug delivery via the nasal or oral air passages is presently done with (a) hand-held, spray-atomizer inhalers, (b) table-top “vaporizer” type systems, (c) by application of volatile substances on the chest, or (d) (for illicit and/or recreational materials) by inhalation of ignition products or direct application of material to the olfactory epithelium.
ii. Alternative Methods for Aesthetic Presentation
Delivery of odoriferous materials to the nose for aesthetic purposes is generally done by (a) spreading volatile and odoriferous materials on the skin, (b) spraying them into the air from cans or bottles, or (c) delivering them into the air by mounting bars, cakes, or open aliquots of the materials in containers that can be fixed to walls, ceilings, and fixtures of the target space.
iii. Alternative Methods for Psychophysics
Testing smell abilities (olfactory psychophysics) is currently done by one of the following three methods: (1) by means of an “olfactometer,” which is the most precise method used, in which complex pumps, valves, and plumbing are used to produce controlled vapor concentrations which are then delivered to the nose for inhalation at controlled temperature, pressure, and flow rate; (2) presenting plastic bottles containing known concentrations of odoriferous materials for a “sniff” by the subject; and (3) by microencapsulating and dispersing odoriferous materials on a paper substrate for release by scratching the surface (scratch and sniff).
iv. Virtual Reality
Three alternative methods have been used for delivering odors to the VR environment: (1) a “smell bar” impregnated with fragrances that can be robotically moved into and out of a position beneath the VR client's nostrils; (2) a robotic “scratch and sniff” system that releases odors into the subject's airstream; and (3) a system using fluid vials of odorants and a fan with air-handling tubes to bring selected odors into the region of the subject's nasal air-space.
C. Uses for the Invention
Diagnosticians, clinical investigators, and basic scientists all need better olfactory test systems. For the clinician, the list of neurologic and neuropsychiatric diseases where olfactory tests can aid in diagnosis is substantial and growing. Olfactory cerebral evoked potentials are also gaining use in the clinic as a means of assessing fronto-limbic and hemispheric abnormalities. An ink-jet dispenser system would be a practical alternative to either the complex olfactometer or the simple squeeze- or scratch-and-sniff approaches. Indeed, the precision of an ink-jet system would provide many research capabilities that would go beyond the typical olfactometer.
Olfactory testing is a vital diagnostic tool in neurology, psychiatry, and neuropsychology. Indeed, there are literally dozens of disorders for which the presence of olfactory deficits is an aid to diagnosis. These disorders include major dementing brain diseases, such as Huntington's chorea, Alzheimer's disease, Down's syndrome, Parkinson's disease, and Picks disease, and a diversity of other conditions including epilepsy, migraine headaches, multiple sclerosis, Korsakov's syndrome, schizophrenia, and certain kinds of head trauma.
Olfactory tests hold the promise of early, presymptomatic diagnosis and differentiation among dementing and other mental diseases. With Parkinson's disease, several groups have found that olfactory testing allows early detection and discriminates among different palsy-disorder subtypes. In Alzheimer's disease, the olfactory deficits also emerge quite early, and correlate with measures such as the extent of CNS volumetric loss. The early appearance of histopathology in the peripheral and central olfactory pathways in Alzheimer's disease, Down's syndrome and certain Parkinson's disease patients are probably responsible for the early emergence of olfactory deficits in those disorders. Early detection of emerging Huntington's chorea symptomology is also favored by recent data.
In all VR settings, adding smells would greatly enhance the sense of presence. Adding odor to any VR system is a cost-effective way to increase operator immersion.
SUMMARY OF THE INVENTION
The present invention is directed to ink-jet-based systems for the micro-dispensation of airborne materials into the inspired airstream or personal airspace of a subject. Preferably the airborne materials are presented in the form of a drug, fragrance or a substance comprising a volatile component. The systems of the present invention have utility in various applications such as virtual reality simulators, instrumentation including medical instrumentation, conditioning of environments, fragrance synthesis and calibration of chemical detection systems.
The microdispensing ink-jet-based systems of the present invention allow the study of temporal integration times, inter-nostril summation, backwards and forwards masking, and other phenomena that have only received the most cursory of attention due to methodological limitations. The microdispensing ink-jet-based systems of the present invention permit precise control of both the temporal envelope of the stimulus and the total number of molecules constituting the stimulus. According to a preferred embodiment of the present invention, the microdispensing ink-jet-based system allows for the digital dispensing of airborne materials. According to another preferred embodiment of the present invention, the microdispensing ink-jet-based system includes dual dispensers on parallel air tubes the airstreams of which can be sep

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