U.S. patent application number 12/327148 was filed with the patent office on 2009-06-04 for system and process for tobaccoless nicotine delivery.
Invention is credited to Douglas C. Dayton, Sung K. Park.
Application Number | 20090139533 12/327148 |
Document ID | / |
Family ID | 40674501 |
Filed Date | 2009-06-04 |
United States Patent
Application |
20090139533 |
Kind Code |
A1 |
Park; Sung K. ; et
al. |
June 4, 2009 |
SYSTEM AND PROCESS FOR TOBACCOLESS NICOTINE DELIVERY
Abstract
A tobaccoless nicotine delivery device permits delivery of
nicotine in a manner similar to a cigarette. The device may include
an impermeable outer layer surrounding a micro-encapsulated
nicotine layer that includes a measured amount of nicotine in a
form that allows nicotine vapor to be released upon rupture of the
micro-encapsulation. A permeable membrane may be disposed adjacent
to the micro-encapsulated nicotine layer that allows pressure to be
applied to the micro-encapsulated nicotine layer while permitting
permeation of released nicotine into a central channel for
inhalation by a user. A mouthpiece may be disposed at an open end
of the central channel in order to provide air resistance to
simulate the inhalation effect of a cigarette.
Inventors: |
Park; Sung K.; (Newton,
MA) ; Dayton; Douglas C.; (Harvard, MA) |
Correspondence
Address: |
STRATEGIC PATENTS P.C..
C/O PORTFOLIOIP, P.O. BOX 52050
MINNEAPOLIS
MN
55402
US
|
Family ID: |
40674501 |
Appl. No.: |
12/327148 |
Filed: |
December 3, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60992217 |
Dec 4, 2007 |
|
|
|
Current U.S.
Class: |
131/274 ;
131/360 |
Current CPC
Class: |
A24F 42/80 20200101;
A24B 15/283 20130101; A24B 15/16 20130101; A24F 42/20 20200101;
A24F 42/60 20200101 |
Class at
Publication: |
131/274 ;
131/360 |
International
Class: |
A24B 15/00 20060101
A24B015/00; A24B 1/00 20060101 A24B001/00 |
Claims
1. A tobaccoless nicotine delivery device comprising: an outer
layer, the outer layer being substantially cylindrical and
impermeable to nicotine; an inner layer, the inner layer being
substantially cylindrical and permeable to nicotine, the inner
layer contained within and substantially coaxial to the outer
layer; a micro-encapsulation layer between the inner layer and the
outer layer, the micro-encapsulation layer including a structure
that encapsulates nicotine, the structure adapted to rupture upon
an application of pressure thereby releasing the nicotine; and a
central channel within the inner layer; and a mouthpiece disposed
at the end of the central channel and coupled thereto, whereby a
user may inhale on the mouthpiece to draw air through the central
channel to receive the nicotine therein when the nicotine is
released from the micro-encapsulation layer.
2. The device of claim 1 further comprising a filter element
disposed between the mouthpiece and an end of the central channel,
the filter element providing air resistance to simulate an
inhalation effect of a cigarette.
3. The device of claim 2 further comprising a flavorant within the
filter element, the flavorant providing a flavor to air passing
therethrough.
4. The device of claim 2 wherein the filter element is
detachable.
5. The device of claim 4 wherein the filter element can be attached
to at least one of a cigarette, a cigar, and a nicotine delivery
device.
6. The device of claim 1 further comprising a one way valve
disposed between the mouthpiece and an end of the central channel
for restricting a passage of nicotine during inhalation.
7. The device of claim 1 wherein the outer layer yields upon
application of a predetermined pressure and the inner layer does
not yield upon application of the predetermined pressure, the
micro-encapsulation layer rupturing to release the nicotine upon an
application of the predetermined pressure thereto, whereby the
nicotine is released upon an application of the predetermined
pressure to the outer layer.
8. The device of claim 1 wherein the structure is adapted to
rupture upon an application of pressure to the outer layer.
9. The device of claim 1 wherein the structure is adapted to
rupture upon an inhalation through the mouthpiece of the
device.
10. The device of claim 1, wherein the micro-encapsulation layer
further includes at least one of an excipient, a flavorant, a
nicotine-impermeable polymer, a nicotine-impermeable plastic, an
oleaginous substance, a saccharide, a protein, a polymeric
material, a co-crystal, and a liposomal nanoparticle.
11. A method of fabricating a tobaccoless nicotine delivery system
comprising: providing a micro-encapsulated nicotine layer in a
substantially cylindrical shape that includes a measured amount of
nicotine within a structure that allows the nicotine to be released
as a nicotine vapor when the structure is ruptured; surrounding the
micro-encapsulated nicotine layer with an impermeable outer layer;
disposing a permeable membrane inside the micro-encapsulated
nicotine layer with a central channel therethrough, the permeable
membrane adapted to allow permeation of the nicotine vapor to the
central channel; and disposing a mouthpiece at an open end of the
central channel.
12. The method of claim 11 further comprising disposing a filter
element in between the mouthpiece and the open end of the central
channel.
13. The method of claim 12 further comprising distributing a
flavorant within the filter element.
14. The method of claim 12 wherein the filter element is
detachable.
15. The method of claim 14 wherein the detachable filter element
can be attached to at least one of a cigarette, a cigar, and a
nicotine delivery device.
16. The method of claim 11 further comprising disposing a one way
valve in between the mouthpiece and the open end of the central
channel that restricts a passage of nicotine therethrough.
17. The method of claim 11 wherein the micro-encapsulation
comprises at least one of an excipient, a flavorant, a
nicotine-impermeable polymer, a nicotine-impermeable plastic, an
oleaginous substance, a saccharide, a protein, a polymeric
material, a co-crystal, and a liposomal nanoparticle.
18. A tobaccoless nicotine delivery device, comprising: an
impermeable outer layer surrounding a micro-encapsulated nicotine
layer, the micro-encapsulated nicotine layer including a measured
amount of nicotine in a structure that allows a nicotine vapor to
be released upon a rupture of the structure; a plurality of
micro-nozzles disposed adjacent to the micro-encapsulated nicotine
layer, wherein the nicotine vapor becomes aerosolized as it passes
through the plurality of micro-nozzles to a central channel of the
tobaccoless nicotine delivery device; and a mouthpiece disposed at
an open end of the central channel.
19. The device of claim 18 further comprising a filter element
disposed in between the mouthpiece and the end of the central
channel.
20. The device of claim 19 wherein the filter element provides air
resistance to simulate an inhalation effect of a cigarette.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Prov. Appl. No.
60/992,217, filed Dec. 4, 2007, the entire content of which is
incorporated herein by reference.
BACKGROUND
[0002] 1. Field
[0003] The present invention relates to a system and method for
tobaccoless nicotine delivery.
[0004] 2. Description of the Related Art
[0005] Current nicotine phase out systems utilize devices do not
closely resemble the actual system and act of smoking. Completely
eliminating the tactile and habitual sensations that are part of
the cigarette experience may delay the adoption of the therapy by
habitual smokers. For example, the nicotine patch completely
removes the tactile sensation of the hand-to-mouth motion of
smoking. Certain nicotine inhalation devices use a system that
resembles a cigarette but are composed of materials that do not
look or feel like cigarettes, such as plastic mouthpieces and
metallic or plastic cartridges.
[0006] Thus, a need exists for a smoking cessation therapy
comprising a nicotine replacement or phase out device that more
closely resembles a cigarette and the experience of smoking a
cigarette.
[0007] These and other systems, methods, objects, features, and
advantages of the present invention will be apparent to those
skilled in the art from the following detailed description of the
preferred embodiment and the drawings.
SUMMARY
[0008] A tobaccoless nicotine delivery device permits delivery of
nicotine in a manner similar to a cigarette. The device may include
an impermeable outer layer surrounding a micro-encapsulated
nicotine layer that includes a measured amount of nicotine in a
form that allows nicotine vapor to be released upon rupture of the
micro-encapsulation. A permeable membrane may be disposed adjacent
to the micro-encapsulated nicotine layer that allows pressure to be
applied to the micro-encapsulated nicotine layer while permitting
permeation of released nicotine into a central channel for
inhalation by a user. A mouthpiece may be disposed at an open end
of the central channel in order to provide air resistance to
simulate the inhalation effect of a cigarette.
[0009] All documents mentioned herein are hereby incorporated in
their entirety by reference. References to items in the singular
should be understood to include items in the plural, and vice
versa, unless explicitly stated otherwise or clear from the text.
Grammatical conjunctions are intended to express any and all
disjunctive and conjunctive combinations of conjoined clauses,
sentences, words, and the like, unless otherwise stated or clear
from the context.
BRIEF DESCRIPTION OF THE FIGURES
[0010] The invention and the following detailed description of
certain embodiments thereof may be understood by reference to the
following figures:
[0011] FIG. 1 shows a nicotine delivery device.
[0012] FIG. 2 shows a cross-sectional view of a nicotine delivery
device.
[0013] FIG. 3 depicts a process for delivering nicotine from a
nicotine delivery device.
[0014] FIG. 4 shows a nicotine delivery device using miniature
nozzles to aerosolize nicotine.
[0015] FIG. 5 shows a nicotine delivery device using miniature
nozzles to aerosolize nicotine.
DETAILED DESCRIPTION
[0016] Disclosed herein are systems and methods directed to
tobaccoless nicotine delivery. The invention disclosed herein is a
drug delivery device that delivers nicotine in a form factor
similar to a cigarette but with no smoke, heat, or tobacco. This
nicotine experience encourages the familiar and important social
interactions that cigarettes generate including familiar tactile,
oral, and visual interactions. However, the majority of the
nicotine is delivered not to the lungs but to the oral and buccal
cavity through which thereafter nicotine gets systemically
distributed.
[0017] FIG. 1 shows a nicotine delivery device. In general, the
nicotine delivery device 100 may be shaped and sized to resemble a
cigarette or the like. An impermeable outer layer 102 of the
nicotine delivery device 100, which may be substantially
cylindrical in shape and generally impermeable to nicotine, may
include graphics or other visual content. The outer layer 102 may
comprise paper, fabric, plastic, metal, or any suitable material.
The outer layer 102 may be formed from similar materials as is
found in a typical cigarette. The outer layer 102 may be colored to
resemble a cigarette. The outer layer 102 may form a part of a
vapor barrier so that nicotine contained within the device 100 can
not escape to the atmosphere.
[0018] FIG. 2 shows a cross-sectional view of the nicotine delivery
device 100 and FIG. 3 depicts a process for delivering nicotine
from the nicotine delivery device 100.
[0019] In an embodiment, a layer 104 of micro-encapsulated nicotine
may be disposed adjacent to the impermeable outer layer 102. The
nicotine 108 may comprise any form of nicotine, such as the
nicotine free base, i.e., (S)-3-(1-Methyl-2-pyrrolidinyl)pyridine,
a compound having the formula C.sub.10H.sub.14N.sub.2, "nicotine
salt", which refers to any mono- or bis-pharmaceutically acid
addition acceptable salt or metal salt of nicotine,
"pharmaceutically acceptable acid addition salt", which refers to
those salts which retain the biological effectiveness and
properties of the free bases and which are not biologically or
otherwise undesirable, formed with inorganic acids such as
hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid,
phosphoric acid and the like, and organic acids such as acetic
acid, propionic acid, glycolic acid, pyruvic acid, oxalic acid,
malic acid, malonic acid, succinic acid, maleic acid, fumaric acid,
tartaric acid, citric acid, benzoic acid, cinnamic acid, mandelic
acid, menthanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic
acid, salicylic acid and the like (For a description of
pharmaceutically acceptable acid addition salts, see Bundgaard, H.,
ed., (1985) Design of Prodrugs, Elsevier Science Publishers,
Amsterdam); and "pharmaceutically acceptable metal salt", which
refers to those salts which retain the biological effectiveness and
properties of the free bases and which are not biologically or
otherwise undesirable, formed with alkali metal ions such as sodium
or potassium; alkaline earth metal ions such as calcium and
magnesium; and other metal ions such as zinc.
[0020] A structure 109 (which is shown in even greater detail in
FIG. 3) such as a micro-encapsulation structure may be designed to
hold a precise amount of nicotine 108 in a form that will allow a
nicotine vapor (see FIG. 5) to be released into a fluid stream
passing around or through the layer 104. The structure 109 may
enclose the nicotine 108 in a nicotine-impermeable barrier or other
nicotine-retaining layer that may be ruptured by finger pressure
(as indicated by an arrow 110) to release the nicotine 108. The
structure 109 may include excipients, flavorants,
nicotine-impermeable polymers and plastics, oleaginous substances
(fats and oils), saccharides, proteins and other non-toxic
polymeric material, co-crystallization, and so forth. The structure
109 may encapsulate the nicotine 108 as nanoparticles in liposomes
or using other encapsulating methods, and the like. In various
embodiments, the nicotine 108 may be in any phase form, such as
solid, liquid, or gaseous.
[0021] In an embodiment, the nicotine 108 may be encapsulated in a
gaseous soluble form, such as vaporized free base nicotine. The
encapsulation may also be in the form of micro-spheres. The
structure 109 surrounding the nicotine 108 may rupture with an
applied pressure (as indicated by an arrow 110), which may include
a finger pressure applied by someone holding the device 100, or
flow-induced or suction pressure created by inhalation on the
device 100, thus allowing the nicotine 108 to escape and enter a
central channel 112 (see FIG. 2) of the nicotine delivery device
where it may be delivered by inhalation to a user. The impermeable
outer layer 102 may inhibit the nicotine 108 from escaping the
nicotine delivery device 100 should the nicotine migrate away from
the central channel 112.
[0022] An inner layer 120 may be positioned adjacent to the layer
104 of micro-encapsulated nicotine. The inner layer 120 may be
substantially cylindrical and coaxial with the outer layer 102, and
may provide a permeable and structural inner layer that provides a
solid base against which to apply exterior force to the device 100
in order to release nicotine 108 from the layer 104 of
micro-encapsulated nicotine. As a result, the nicotine 108 may
permeate the inner layer 120 and enter the central channel 112 for
inhalation. The inner layer 120 may include any gas-permeable
material, such as paper, perforated plastic, polymers, and the
like, as well as various combinations of these. In general, the
outer layer 102 may yield upon application of a predetermined
amount of pressure and the inner layer 120 may not yield (e.g.,
remains rigid) upon application of the predetermined amount of
pressure to the outer layer, so that the structure 109 of the
intermediate layer 104 ruptures and releases the nicotine 108.
[0023] In an embodiment, the inner layer 120 may be permeable to
ambient air. For example, when a user wishes to use the device,
they may remove a cover that permits the exposure of the central
channel 112 to air, either through an open end 105 of the device
100, or through a porous region 107 of the outer layer 102 (which
may be covered by a cap when the device 100 is not in use). In an
embodiment, the central channel 112 may be capped on an inhaling
end by a filter element 114 or other porous element. The filter
element 114 may provide air resistance to simulate the inhalation
effect of a cigarette but may be permeable to nicotine 108 released
within the central channel 112. The filter element 114 may also
provide a medium for inclusion of flavorants to flavor the nicotine
108 as it passes through the filter element 114. For example, the
flavorant may be menthol, tobacco, or any other flavor. In an
embodiment, the filter element 114 may be a detachable element.
When a user wishes to use the nicotine delivery device 100, they
may attach a filter element 114 corresponding to the flavorant of
their choosing. The filter element 114 may be changed during use to
allow a user to try different flavorings. In an embodiment, the
filter element 114 may be attached to any nicotine inhalation
device, cigarette, cigar, and the like to provide flavoring.
[0024] In an embodiment, the central channel 112 may be capped by a
one way valve 118 or other flow restrictor to restrict the intake
of nicotine upon inhalation. The one way valve 118 may provide a
user with a sensation of inhaling a cigarette by restricting air
flow in a manner similar to a cigarette filter. In an embodiment,
the one way valve 118 may take the place of the filter element 114
or work with the filter element 114 in capping the end of the
nicotine delivery device. In any event, a mouthpiece 122 may be
placed on the end of the filter element 114 or one way valve 118.
The user may rupture the structure 109 surrounding the nicotine 108
in the layer 104 of micro-encapsulated nicotine as generally
described above, and then during or after this rupturing, inhale
using the mouthpiece. In operation, inhalation may draw air (e.g.,
through the porous region 107 of the outer layer 102, or through an
open end 105 of the central channel 112), and with it, nicotine 108
from the layer 104 of micro-encapsulated nicotine, into the mouth
of the user from where it may be systemically distributed.
[0025] Referring to FIG. 4 and FIG. 5, the nicotine delivery device
100 may include a plurality of micro-nozzles 202 for aerosolizing
nicotine 108 for ingestion and/or inhalation. The micro-nozzles 202
may be disposed as a layer disposed within the outer layer 102 of
the device 100. As pressure is applied on the outer layer 102 (as
shown in an arrow 410 in FIG. 5), the nicotine 108 may be released
from the structure 109 as a nicotine vapor and enter a micro-nozzle
202 in which the nicotine becomes aerosolized. The aerosolized
nicotine may enter the central channel 112 directly from the
micro-nozzles 202 or it may first have to permeate a permeable
inner layer such as the inner layer 120 described above, which may
or may not be present in addition to the micro-nozzles 202. In some
embodiments, the micro-nozzles 202 may form the inner layer
120.
[0026] Thus it will be appreciated that there is generally
described herein a tobaccoless nicotine delivery device and a
method for using same to orally deliver nicotine to a user in a
manner similar to smoking a cigarette. It will be appreciated that
the various steps identified and described above may be varied, and
that the order of steps may be adapted to particular applications
of the techniques disclosed herein. All such variations and
modifications are intended to fall within the scope of this
disclosure. As such, the depiction and/or description of an order
for various steps should not be understood to require a particular
order of execution for those steps, unless required by a particular
application, or explicitly stated or otherwise clear from the
context.
[0027] While the invention has been disclosed in connection with
the preferred embodiments shown and described in detail, various
modifications and improvements thereon will become readily apparent
to those skilled in the art. Accordingly, the spirit and scope of
the present invention is not to be limited by the foregoing
examples, but is to be understood in the broadest sense allowable
by law.
[0028] All documents referenced herein are hereby incorporated by
reference.
* * * * *