U.S. patent application number 12/075480 was filed with the patent office on 2008-10-02 for controllable release nasal system.
This patent application is currently assigned to Searete LLC. Invention is credited to W. Daniel Hillis, Roderick A. Hyde, Muriel Y. Ishikawa, Elizabeth A. Sweeney, Clarence T. Tegreene, Richa Wilson, Lowell L. Wood, Victoria Y.H. Wood.
Application Number | 20080243056 12/075480 |
Document ID | / |
Family ID | 38668339 |
Filed Date | 2008-10-02 |
United States Patent
Application |
20080243056 |
Kind Code |
A1 |
Hillis; W. Daniel ; et
al. |
October 2, 2008 |
Controllable release nasal system
Abstract
Embodiments of devices and system for controllable nasal
delivery of materials are described. Methods of use of such devices
and system and software for controlling the operation of such
devices and systems are also disclosed.
Inventors: |
Hillis; W. Daniel; (Encino,
CA) ; Hyde; Roderick A.; (Livermore, CA) ;
Ishikawa; Muriel Y.; (Livermore, CA) ; Sweeney;
Elizabeth A.; (Seattle, WA) ; Tegreene; Clarence
T.; (Bellevue, WA) ; Wilson; Richa; (San
Francisco, CA) ; Wood; Lowell L.; (Livermore, CA)
; Wood; Victoria Y.H.; (Livermore, CA) |
Correspondence
Address: |
Clarence T. Tegreene, Esq.;Intellectual Property Counsel
Searete LLC, 1756 - 114th Ave. S.E., Suite 110
Bellevue
WA
98004
US
|
Assignee: |
Searete LLC
Bellevue
WA
|
Family ID: |
38668339 |
Appl. No.: |
12/075480 |
Filed: |
March 11, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11417898 |
May 4, 2006 |
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12075480 |
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11403230 |
Apr 12, 2006 |
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11417898 |
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Current U.S.
Class: |
604/66 |
Current CPC
Class: |
A61M 31/00 20130101;
A61M 2230/06 20130101; A61K 9/0043 20130101; A61M 15/08 20130101;
A61M 2230/201 20130101; A61M 2230/30 20130101; A61M 2205/3306
20130101; A61B 5/0002 20130101; A61B 2562/17 20170801; A61M 2230/06
20130101; A61M 2230/30 20130101; A61M 2230/50 20130101; A61M
2205/3303 20130101; A61M 2230/201 20130101; A61M 15/085 20140204;
A61M 2205/3331 20130101; A61M 2230/005 20130101; A61M 2230/005
20130101; A61M 2230/005 20130101; A61B 5/411 20130101; A61M
2230/005 20130101; A61M 2230/50 20130101; A61B 5/418 20130101 |
Class at
Publication: |
604/66 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
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100. A signal bearing medium comprising: one or more instructions
for controlling the release of material from a delivery device
mounted within a nasal region of a subject, the one or more
instructions including: a control signal generation module capable
of generating a delivery control signal corresponding to a desired
pattern of delivery of a material into a nasal region of a subject
from a delivery portion of the delivery device mounted within the
nasal region of the subject; and at least one of a data storage
module capable of storing pattern data or pattern parameters
representing the desired pattern of delivery of the material into
the nasal region of the subject or a sensing module capable of
receiving and processing a sense signal from a sensor portion of
the delivery device, wherein the control signal generation module
is configured to generate the delivery control signal based upon at
least one of the pattern data, pattern parameters, or sense
signal.
101. The signal bearing medium of claim 100, the one or more
instructions including both a data storage module capable of
controlling storage of pattern data or pattern parameters
representing the desired pattern of delivery of the material into
the nasal region of the subject and a sensing module capable of
receiving and processing a sense signal from a sensor portion of
the delivery device.
102. The signal bearing medium of claim 101, wherein the data
storage module is capable of storing a sense signal received from
the sensing module.
103. The signal bearing medium of claim 102, wherein the data
storage module is capable of storing a processed sense signal from
the sensor portion of the delivery device.
104. The signal bearing medium of claim 100, the one or more
instructions including a user interface module configured to
receive user input of one or more user-enterable parameters from a
user interface device.
105. The signal bearing medium of claim 100, the one or more
instructions including a user interface module configured to
receive user input of a desired delivery pattern from a user
interface device.
106. The signal bearing medium of claim 105, wherein the user
interface module is configured to receive the desired delivery
pattern in the form of a digital data transmission.
107. The signal bearing medium of claim 100, the one or more
instructions including a data storage module configured to store
one or more values from the delivery device.
108. The signal bearing medium of claim 107, wherein the one or
more instructions include the sensing module capable of receiving
and processing a sense signal from a sensor portion of the delivery
device, and wherein at least a portion of the one or more values
are sense signal values received from the sensing module.
109. The signal bearing medium of claim 107, wherein the one or
more instructions include the sensing module capable of receiving
and processing a sense signal from a sensor portion of the delivery
device, and wherein at least a portion of the one or more values
are one or more sense parameters received from the sensing
module.
110. The signal bearing medium of claim 107, wherein at least a
portion of the one or more values are delivery control signal
values from the control signal generation module.
111. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by filtering.
112. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by windowing.
113. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by noise reduction.
114. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by signal averaging.
115. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by feature detection.
116. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by time-domain analysis.
117. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by frequency-domain analysis.
118. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by feature extraction.
119. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by comparing the sense signal with a template sense
signal.
120. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by performing sorting.
121. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by performing data reduction.
122. The signal bearing medium of claim 100, the one or more
instructions including a sensing module capable of receiving and
processing a sense signal from a sensor portion of the delivery
device, the sensing module being capable of processing the sense
signal by performing endpoint determination.
123. The signal bearing medium of claim 100, wherein the control
signal generation module is capable of generating the delivery
control signal by calculating the delivery control signal based
upon one or more stored parameters.
124. The signal bearing medium of claim 123, wherein at least a
portion of the one or more stored parameters are specific to the
subject.
125. The signal bearing medium of claim 100, wherein the control
signal generation module is capable of generating the delivery
control signal from a stored release pattern.
126. The signal bearing medium of claim 101, the one or more
instructions including a user interface module configured to
receive user input of one or more user-enterable parameters or a
desired delivery pattern from a user interface device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] For purposes of the United States Patent Office (USPTO)
extra-statutory requirements, the present application is a DIVISION
application of U.S. patent application Ser. No. 11/417,898 titled
CONTROLLABLE RELEASE NASAL SYSTEM, naming W. DANIEL HILLIS,
RODERICK A. HYDE, MURIEL Y. ISHIKAWA, ELIZABETH A. SWEENEY,
CLARENCE T. TEGREENE, RICHA WILSON, LOWELL L. WOOD, JR., AND
VICTORIA Y. H. WOOD as inventors, filed 4 May 2006, which is
co-pending, or is an application of which a co-pending application
is entitled to the benefit of the filing date. The present
application claims the benefit of the earliest available effective
filing date(s) (i.e., claims earliest available priority dates for
other than provisional patent applications or claims benefits under
35 USC .sctn. 119(e) for provisional patent applications) for any
and all applications to which patent application Ser. No.
11/417,898 claims the benefit of priority, including but not
limited to U.S. patent application Ser. No. 11/403,230, titled
LUMENALLY-ACTIVE DEVICE naming as inventors BRAN FERREN, W. DANIEL
HILLIS, RODERICK A. HYDE, MURIEL Y. ISHIKAWA, EDWARD K. Y. JUNG,
NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE,
RICHA WILSON, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, filed
12 APRIL 2006. All subject matter of U.S. patent application Ser.
No. 11/417,898 and of any and all applications from which it claims
the benefit of the earliest available effective filing date(s) is
incorporated herein by reference to the extent such subject matter
is not inconsistent herewith.
[0002] The USPTO has issued new rules regarding Claims and
Continuations, effective Nov., 1, 2007, 72 Fed. Reg. 46716-21 Aug.
2007, available at:
http://www.uspto.gov/web/offices/com/sol/notices/72fr46716.pdf;
wherein 37 CFR 1.78(d)(1) states that the USPTO will refuse to
enter any specific reference to a prior-filed application that
fails to satisfy any of 37 CFR 1.78(d)(1)(i)-(vi). The applicant
entity has provided above a specific reference to the
application(s) from which priority is being claimed--as required by
statute. Applicant entity understands that the statute is
unambiguous in its specific reference language and does not require
either a serial number or any characterization, such as
"continuation" or "continuation-in-part" or "divisional," for
claiming priority to U.S. patent applications. Notwithstanding the
foregoing, the applicant entity has provided above a specific
reference to the application(s) from which priority is being
claimed that satisfies at least one of the extra-statutory
requirements of 37 CFR 1.78(d)(1)(i)-(vi), but expressly points out
that such designations are not to be construed in any way as any
type of commentary and/or admission as to whether or not the
present application contains any new matter in addition to the
matter of its parent application(s). Further, any designation that
the present application is a "division" should not be construed as
an admission that the present application claims subject matter
that is patentably distinct from claimed subject matter of its
parent application.
BACKGROUND
[0003] Devices and systems have been developed for use in various
body lumens, particularly in the cardiovascular system, digestive,
and urogenital tract. Catheters are used for performing a variety
of sensing and material delivery tasks. Stents are implanted in
blood vessels for the purpose of preventing stenosis or restenosis
of blood vessels. Capsules containing sensing and imaging
instrumentation, that may be swallowed by a subject and which
travel passively through the digestive tract have also been
developed. Robotic devices intended to move through the lower
portion of the digestive tract under their own power are also under
development.
SUMMARY
[0004] The present application describes devices, systems, and
related methods for delivery of a material to a nasal region of a
subject. Embodiments of delivery devices and systems for placement
within a nasal region are disclosed. In one aspect, a system
includes but is not limited to a structural element including a
positioning portion configured for contacting an interior surface
of a nasal region and mounting the structure element within the
nasal region of a subject, a delivery portion mounted relative to
the structural element and configured to release at least one
material responsive to a delivery control signal, and control
signal generation circuitry configured to generate a delivery
control signal corresponding to a desired pattern of release of the
at least one material into the nasal region. In addition to the
foregoing, other system aspects are described in the claims,
drawings, and text forming a part of the present disclosure.
[0005] In one aspect, a method includes but is not limited to
releasing at least one material from a delivery portion of a
delivery device mounted within a nasal region of a subject in
response to a delivery control signal corresponding to a desired
release pattern. The method may include sensing a parameter of
interest in the nasal region with a sensor in the delivery device
and controlling the release of the at least one material based upon
the value of the parameter of interest. In some aspects, the method
may include generating the delivery control signal. In addition to
the foregoing, other method aspects are described in the claims,
drawings, and text forming a part of the present disclosure.
[0006] Various aspects of the operation of such delivery devices
may be performed under the control of hardware, software, firmware,
or a combination thereof. In one or more various aspects, related
systems include but are not limited to circuitry and/or programming
for effecting the herein-referenced method aspects; the circuitry
and/or programming can be virtually any combination of hardware,
software, and/or firmware configured to effect the
herein-referenced method aspects depending upon the design choices
of the system designer. Software for operating a delivery device
according to various embodiments is also described.
[0007] The foregoing summary is illustrative only and is not
intended to be in any way limiting. In addition to the illustrative
aspects, embodiments, and features described above, further
aspects, embodiments, and features will become apparent by
reference to the drawings and the following detailed
description.
BRIEF DESCRIPTION OF THE FIGURES
[0008] FIG. 1 is a side cross-sectional view of an embodiment of
controllable release nasal device emplaced in a nostril;
[0009] FIG. 2 is a front cross-sectional illustration of the
controllable release nasal device depicted in FIG. 1;
[0010] FIG. 3 is a detailed view of the controllable release nasal
device shown in FIGS. 1 and 2;
[0011] FIG. 4 is an illustration of a lumenally active device;
[0012] FIG. 5 is an illustration of another embodiment of a
controllable release nasal device;
[0013] FIG. 6 is a front cross-section view of the device of FIG.
5;
[0014] FIG. 7 is a further depiction of the device of FIG. 6;
[0015] FIG. 8 is a front cross-sectional view of an embodiment of a
controllable release nasal device including a clip;
[0016] FIG. 9 is a side cross-sectional view of the embodiment of
FIG. 8;
[0017] FIG. 10 is a front cross-sectional view of another
embodiment of a controllable release nasal device;
[0018] FIG. 11 is a side cross-sectional view of the embodiment of
FIG. 10;
[0019] FIG. 12 is an illustration of an embodiment of a structural
element;
[0020] FIG. 13 is an illustration of another embodiment of a
structural element;
[0021] FIG. 14 is an illustration of another embodiment of a
structural element;
[0022] FIG. 15 is an illustration of another embodiment of a
structural element;
[0023] FIG. 16 is an illustration of a further embodiment of a
structural element;
[0024] FIG. 17 is an illustration of another embodiment of a
structural element;
[0025] FIG. 18 is an illustration of another embodiment of a
structural element;
[0026] FIGS. 19A and 19B depicted changes in dimension of an
embodiment;
[0027] FIG. 20 is a cross-sectional view of an embodiment of a
structural element;
[0028] FIG. 21 is a cross-sectional view of another embodiment of a
structural element;
[0029] FIG. 22 is a cross-sectional view of another embodiment of a
structural element;
[0030] FIG. 23 is a cross-sectional view of another embodiment of a
structural element;
[0031] FIG. 24 is a cross-sectional view of another embodiment of a
structural element;
[0032] FIG. 25 is a cross-sectional view of yet another embodiment
of a structural element;
[0033] FIG. 26 is a front cross-sectional depiction of release of
material from a controllable release nasal device;
[0034] FIG. 27 is a side cross-sectional view of delivery of
material to the nasal mucosa from a controllable release nasal
device;
[0035] FIG. 28 is a side cross-sectional view of delivery of
material to the olfactory region from a controllable release nasal
device;
[0036] FIG. 29 is a side cross-sectional view of delivery of
material toward the nasopharynx from a controllable release nasal
device;
[0037] FIG. 30 is an illustration of a device including stored
deliverable material;
[0038] FIG. 31 is an illustration a delivery device including an
extension;
[0039] FIG. 32 is a cross-sectional view of an embodiment of a
device including a stored deliverable material and a barrier
release mechanism;
[0040] FIG. 33 is a cross-sectional view of another embodiment of a
device including a stored deliverable material and a barrier
release mechanism;
[0041] FIGS. 34A and 34B are depictions of the release of a stored
deliverable material from a reservoir via a rupturable barrier;
[0042] FIGS. 35A and 35B are depictions of the release of a stored
deliverable material from a reservoir via a degradable barrier;
[0043] FIGS. 36A and 36B are depictions of the release of a stored
deliverable material from a reservoir via a barrier having
controllable permeability;
[0044] FIGS. 37A and 37B are depictions of the release of a stored
deliverable material from a carrier material;
[0045] FIG. 38 is an illustration of an embodiment of a
controllable release nasal system including an external material
source;
[0046] FIG. 39 is a close-up illustration of the nasal device
portion of the system of FIG. 38;
[0047] FIG. 40 is a block diagram of a controllable release nasal
system;
[0048] FIG. 41 is a schematic diagram illustrating components of
control circuitry of a controllable release nasal system;
[0049] FIG. 42 is an illustration of a controllable release nasal
system including an external control portion;
[0050] FIG. 43 is a block diagram of a controllable release nasal
system including an external control portion;
[0051] FIG. 44 is a front cross-sectional view of an embodiment of
a controllable release nasal device;
[0052] FIG. 45 is an illustration of an embodiment of controllable
release nasal device including a delivery portion and a sensor;
[0053] FIG. 46 is an illustration of another embodiment of
controllable release nasal device including a delivery portion and
a sensor;
[0054] FIG. 47 is an illustration of another embodiment of
controllable release nasal device including a delivery portion and
a sensor;
[0055] FIG. 48 depicts an embodiment of an active portion including
a heating element;
[0056] FIG. 49 depicts an embodiment of an active portion including
a cooling element;
[0057] FIG. 50 depicts an embodiment of an active portion including
an electromagnetic radiation source;
[0058] FIG. 51 depicts an embodiment of an active portion including
an acoustic signal source;
[0059] FIG. 52 depicts an embodiment of an active portion including
a negative pressure source;
[0060] FIG. 53 depicts an embodiment of an active portion including
a positive pressure source;
[0061] FIG. 54 is an illustration of another embodiment of a
controllable release nasal device;
[0062] FIG. 55 is a depiction of an embodiment of a controllable
release nasal device including a material collection structure;
[0063] FIG. 56 is a flow diagram of a method of delivering a
material to a nasal region of a subject;
[0064] FIG. 57 is a flow diagram of a method of delivering a
material to a nasal region of a subject;
[0065] FIG. 58 is a flow diagram of a method of delivering a
material to a nasal region of a subject;
[0066] FIG. 59 is a flow diagram of a method of delivering a
material to a nasal region of a subject;
[0067] FIG. 60 is a flow diagram of a method of delivering a
material to a nasal region of a subject;
[0068] FIG. 61 is a flow diagram showing further aspects of a
method of delivering a material to a nasal region of a subject;
[0069] FIG. 62 is a flow diagram showing further aspects of a
method of delivering a material to a nasal region of a subject;
[0070] FIG. 63 is a flow diagram showing further aspects of a
method of delivering a material to a nasal region of a subject;
[0071] FIG. 64 is a flow diagram showing further aspects of a
method of delivering a material to a nasal region of a subject;
[0072] FIG. 65 is a flow diagram showing further aspects of a
method of delivering a material to a nasal region of a subject;
and
[0073] FIG. 66 is a schematic diagram of software for controlling
release of a material from device mounted within a nasal region of
a subject.
DETAILED DESCRIPTION
[0074] In the following detailed description, reference is made to
the accompanying drawings, which form a part hereof. In the
drawings, similar symbols typically identify similar components,
unless context dictates otherwise. The illustrative embodiments
described in the detailed description, drawings, and claims are not
meant to be limiting. Other embodiments may be utilized, and other
changes may be made, without departing from the spirit or scope of
the subject matter presented here.
[0075] FIG. 1 is a cross-sectional illustration of a head 10 of a
person, showing the basic anatomy of nasal region 12. The mouth 14
and tongue 16 are also indicated in FIG. 1. Nasal region 12
includes nostril 18 and nasal cavity 20. Nasopharynx 22 is the
uppermost portion of the pharynx (throat) 24, which connects to
esophagus 26. Nasopharynx 22 connects to nasal cavity 20 via
internal naris 28. Trachea (windpipe) 30 lies anterior to esophagus
26. Epiglottis 32 closes off the opening of larynx 34 leading to
trachea 30 (shown with a solid line) during eating and drinking,
and opens (shown with a dashed line) to permit the flow of air
between pharynx 24 and trachea 30 during breathing. Nasal conchae
36 form shelf-like projections which may be seen more clearly in
the front cross-sectional view of FIG. 2. The olfactory region 38
is located in the uppermost portion of nasal cavity 20. The nasal
cavity 20 is divided into right side and left sides by nasal septum
40, as shown in FIG. 2. Nasal mucosa 42 lines the interior of the
nasal cavity 20, as shown by a gray line in FIG. 2. (The nasal
mucosa will not be indicated in other figures, but may be expected
to be present within the nasal cavity under normal
circumstances.)
[0076] In the example depicted in FIGS. 1 and 2, a delivery device
44 forming at least a portion of a controllable release nasal
system is positioned within nostril 18 of nasal region 12. Delivery
device 44 may be a self-expanding device that may be positioned
within the nostril, for example by a care provider or by the person
using the delivery device, and then may expand intrinsically or be
made to expand under control to provide a snug fit sufficient to
retain delivery device 40 within the nostril for as long as is
desired.
[0077] FIG. 3 illustrates further aspects of delivery device 44. As
shown in FIG. 3, in one aspect, an embodiment of a controllable
release nasal system may include a structural element 50 including
at least one positioning portion 52 configured for contacting an
interior surface 54 of a nasal region (in this example, nostril 18)
and mounting the structural element 50 within the nasal region of a
subject; a delivery portion 56 mounted relative to the structural
element 50 and configured to release at least one material
responsive to a delivery control signal; and control signal
generation circuitry 58 configured to generate a delivery control
signal corresponding to a desired pattern of release of the at
least one material into the nasal region. In the example of FIG. 3,
positioning portion 52 is the exterior surface of structural
element 50, which mounts structural element 50 within the nasal
region (i.e., nostril 18 in this example) by a pressure and/or
frictional fit. In other embodiments, other types of positioning
portions may be used, as will be discussed herein. Delivery device
44 may include one or more sensor 62, which may be capable of
detecting a physiological or environmental condition. Control
signal generation circuitry 58 may receive as input a signal from
sensor 62, which may be used in the calculation of the control
signal for controlling the release of material from delivery
portion 56.
[0078] A delivery portion of a controllable release nasal system
(for example, delivery portion 56 of delivery device 44 in FIG. 3)
may be designed to release material into different portions of the
nasal region depending on various considerations, including the
specific material being delivered, the intended effect of the
material, sensed ambient physiological and/or environmental
conditions, and, in some applications, the mechanism of absorption
or uptake of the material by the body. In some embodiments, the
material may be released directly into the nasal mucosa for
absorption by local tissue or by blood circulating through local
fine capillaries, while in other embodiments, the material may be
released into the nasal cavity in the form of a liquid, a gas,
finely dispersed particles or droplets, or mixtures thereof, which
may be carried by ambient airflow to more distant portions of the
nasal mucosa or other portions of the respiratory tract, which may
be exhaled along with exhaled gases, or which may be inhaled to
various depths of the bronchial tree or within or into the
gas-exchange portions of the lung, for example. In some
embodiments, the finely dispersed particles or droplets may be
controlled to be within the diameter-range of 0.01 to 0.00001 cm,
for example.
[0079] Materials delivered to the nasal regions may have a number
of effects or uses. In some cases, materials such as odorants or
neurotransmitters may stimulate the olfactory region to produce a
sensory effect, for example for an esthetic, recreational, or
medical purpose (e.g., aromatherapy; blockade, modification or
enhancement of the flavors of foods, drinks, or orally delivered
medications; one-or-more scents or olfactory modulators delivered
according to a pattern or script in order to provide an olfactory
analog to a soundtrack of a motion picture; amplified delivery of
scents or odorants or olfactory modulators to supplement
deficiencies or enhance to supra-normal levels the innate sense of
smell, etc.). In some embodiments, materials may be released for
delivery to the nasal mucosa and/or to sites elsewhere in the
respiratory tract for absorption into the blood to effect systemic
delivery of the materials, which may be, for example, various types
of drugs, medications, contraceptives, hormones, vaccines,
tolerance-inducing allergens, or therapeutic compounds. In some
embodiments, materials may be delivered to the nasal mucosa or
elsewhere in the respiratory tract to produce a local effect (e.g.,
to reduce inflammation or swelling of tissues, or for
anti-pathogenic action) or inhaled into the lungs either to produce
a local effect or for systemic uptake. In some embodiments, the
material may form a functional coating on the surface of the nasal
region, respiratory tract portion or lung, rather than be absorbed,
e.g. to function as a surfactant, a protective layer, or a barrier.
In some embodiments, one or more materials delivered into the nasal
region may act on exhaled gases to act on or in cooperation with
substances in the exhaled gases, for example to remove undesired
materials from the exhaled gases, or to enhance, amplify or modify
the effect of substances of interest in the exhaled gases.
[0080] Some embodiments of controllable release nasal systems may
be considered to be lumenally active devices. Lumenally active
devices in general are described in commonly owned U.S. patent
application Ser. No. 11/403,230, entitled "Lumenally Active Device"
and filed Apr. 12, 2006, which is incorporated herein by reference.
In some aspects, as described herein, controllable release nasal
systems may release materials into a body lumen (e.g., a nasal
cavity or nostril), while in other aspects, controllable release
nasal systems may release materials into tissue surrounding the
lumen and not into the lumen per se. The "Lumenally Active Device"
patent application describes a lumenally active device which may
include a structural element configured to fit within at least a
portion of a body lumen, the structural element including a
lumen-wall-engaging portion and a fluid-contacting portion
configured to contact fluid within the body lumen; a sensor capable
of detecting a condition of interest in the fluid; response
initiation circuitry operatively connected to the sensor and
configured to generate a response initiation signal upon detection
of the condition of interest in the fluid by the sensor; and an
active portion operatively connected to the response initiation
circuitry and capable of producing a response upon receipt of the
response initiation signal. Such a system is depicted in FIG. 4,
which shows a delivery device 110 positioned in a body lumen 112.
Body lumen 112 is defined by wall portions 114, which may be the
walls of lumen-containing structure within the body of an organism,
e.g., a nasal region or, in other embodiments and applications, a
blood vessel or other lumen containing structure. Delivery device
110 includes structural element 116, sensor 118, response
initiation circuitry 120, and active portion 122. A fluid may flow
through lumen 112. The term fluid, as used herein, may refer to
liquids, gases, and other compositions, mixtures, or materials
exhibiting fluid behavior. The fluid within the body lumen may
include a liquid, or a gas or gaseous mixtures. As used herein, the
term fluid may encompass liquids, gases, or mixtures thereof that
also include solid particles in a fluid carrier. Liquids may
include mixtures of two or more different liquids, solutions,
slurries, or suspensions. Examples of liquids present within body
lumens include blood, lymph, serum, urine, semen, digestive fluids,
tears, saliva, mucus, cerebro-spinal fluid, intestinal contents,
bile, epithelial exudate, or esophageal contents. Liquids present
within body lumens may include synthetic or introduced liquids,
such as blood substitutes or drug, nutrient, or (possibly buffered)
saline or electrolyte solutions. Fluids may include liquids
containing dissolved gases or gas bubbles, or gases containing fine
liquid droplets or solid particles. Gases or gaseous mixtures found
within body lumens may include inhaled and exhaled air, e.g. in the
nasal or respiratory tract, or intestinal gases. According to this
definition, fluids within the nasal region will typically include
gases and mixtures of gases. Fluid may flow through the central
openings 126 of structural element 116, with the interior surface
of structural element 116 forming fluid-contacting surface 128. In
the embodiment of FIG. 4, sensor 118 and active portion 122 may be
located at a fluid-contacting surface 128. Outer surface 130 of
structural element 116 may function as a lumen-wall engaging
portion, providing a frictional fit with wall portions 114. In
other embodiments of delivery devices, other structures and methods
for engaging the lumen wall may be employed.
[0081] Structural elements may include two or more openings or
lumens passing through the structural element, rather than a single
central opening as depicted in FIG. 4, and the lumen-wall-engaging
portion of the structural element is not limited to embodiments
having a substantially smooth outer surface that conforms to the
interior cross-section of a nasal lumen, but may have a variety of
surface shapes, textures, and contours, some of which may conform
or contact only a portion or portions of the interior cross section
of a nasal lumen.
[0082] Embodiments of the lumenally-active system may be configured
for use in various different body lumens of an organism including,
for example, a nostril or nasal cavity, one or more portions of the
respiratory tract, the cardiovascular system (e.g., a blood
vessel), the lymphatic system, the biliary tract, the urogenital
tract, the oral cavity, the digestive tract, the tear ducts, a
glandular system, a reproductive tract or portion thereof, the
cerebral ventricles, spinal canal, and other fluid-containing
structure of the nervous system of an organism. Other
fluid-containing lumens within the body may be found in the
auditory or visual systems, or in interconnections thereof, e.g.,
the Eustachian tubes.
[0083] Wherever a controllable release nasal system is to be used,
the dimensions and mechanical properties (e.g., rigidity) of the
delivery device, and particularly of the structural element of the
delivery device, may be selected for compatibility with the
location of use, in order to provide for reliable positioning of
the device and to prevent damage to the lumen-containing
structure.
[0084] The structural element may include a self-expanding
structure configured to expand to mount the structural element
within the nasal region of the subject. For example, structural
element 50 of the delivery device depicted in FIGS. 1 through 3 is
a generally spring-like structure that may be formed of a loop of
resilient, springy, or self-expanding material which may be
compressed slightly by virtue of slit 60, as shown in FIG. 3, to
permit insertion into the nostril and which may then expand
sufficiently to cause the structural element to be retained within
the nostril until it is to be removed. In such embodiments, the
resilient, springy or self-expanding portion of the structural
element may function as the positioning portion of the delivery
device.
[0085] FIGS. 5 through 7 depict a further spring-like structural
element which may be placed between the nasal conchae and which may
expand slightly to secure it in place. FIG. 5 depicts structural
element 150. Structural element 150 includes end regions 152,
curved portion 154, inner surface 156 and outer surface 158.
Structural element 150 may also include a delivery portion and
control signal generation circuitry (not shown). Structural element
150 may be compressed by pressing together end regions 152. As
shown in FIG. 6, structural element 150 may be inserted between two
nasal conchae 36, and allowed to expand to hold it in place. The
position of structural element 150 relative to nostrils 18, nasal
septum 40, and nasal conchae 36, can be seen in both FIG. 6 and
FIG. 7.
[0086] The self-expanding structure may permit the structural
element to be placed within a nasal region (e.g., a nostril, or a
portion of a nasal cavity) while in a first, contracted, state and
then transformed into a second, expanded, state of a nature such
that the structural element contacts opposing interior walls of a
portion of the nasal region in order to satisfactorily position and
mount the structural element at least temporarily within the nasal
region.
[0087] In some embodiments, as depicted in FIGS. 8 and 9, a
structural element 160 may include a clip structure 162, at least a
portion of which is configured to extend outside the nasal region
of the subject. In FIG. 8, clip structure 162 clamps onto nasal
septum 40, with a portion projecting into a first nostril 18a, with
structural element 160 residing within second nostril 18b.
Construction of clip structures of this general type may be as
described, for example, in U.S. Pat. No. 5,947,119, which is
incorporated herein by reference. In the embodiment shown in FIG.
8, a single structural element 160 is shown. In other embodiments
(not shown), a clip structure may have associated with it two or
more structural elements, with one residing in each nostril. In
still other embodiments, two or more structural elements may reside
in an individual nostril, or in both nostrils. FIG. 9 is a side
view of structural element 160 with clip structure 162.
[0088] In some embodiments, a controllable release nasal system may
be configured to reside entirely within the nasal region of the
subject. In other embodiments of a controllable release nasal
system, a first portion of the controllable release nasal system
may be configured to reside within the nasal region of the subject
and a second portion of the controllable release nasal system may
be configured to reside external to the nasal region of the
subject. The second portion may be simply structural, like the
extra-nasal portion depicted in FIG. 8. However, in some
embodiments, the second portion of the controllable release nasal
system may include components such as the control signal generation
circuitry or a source of the material delivered by the device (or a
component thereof).
[0089] FIGS. 10 and 11 depict an embodiment of a structural element
180 in which the positioning portion may include an adhesive 182.
As shown in the front sectional view of FIG. 10, structural element
180 is located in nasal cavity 20 and positioned against nasal
septum 40 with a layer of adhesive 182. The side sectional view of
FIG. 11 illustrates the position of structural element 180 within
nasal cavity 20. In other embodiments, the positioning portion may
include a remotely guidable section and/or a means for facilitating
extraction when it is desired to remove the structural element or
device from the nasal region. In some embodiments, the positioning
portion may include other structures for mounting or positioning
the structural element within at least a part of a nasal region.
The positioning portion may include one or more barb-like
structures (e.g., as depicted in FIG. 21), at least one
vacuum-generating device capable of mounting the structural element
within a nasal region by producing sufficient vacuum (or suction)
to cause the structural element to stick to at least a portion of
the nasal region, or at least one hair-engaging structure (which
may be, for example, a clip, clasp, grip or coil-like structure
capable of reversibly engaging one or more hairs within the nasal
region to mount the structural element within the nasal
region).
[0090] In the various embodiments disclosed herein, the positioning
portion may be used to mount the structural element of the delivery
device within a nasal region for a use period that may be brief
(e.g. on the order of minutes) or extended (weeks, months, or
longer). Following placement of the structural element in the
desired location for use, which may be done manually or with the
use of an insertion device, the delivery device may be held in
place without further intervention. The positioning portion may
include any fastening structure or mechanism that is capable of
mounting (securing, retaining and/or supporting) the structural
element within the nasal region for the duration of its use without
the need for the person using the device (or another party) to hold
or otherwise maintain the structural element in place.
[0091] As shown variously in FIGS. 1 through 11, in some
embodiments, at least a part of the structural element may be
configured for mounting within a nostril of the subject, and in
some embodiments at least a part of the structural element may be
configured for mounting within a nasal cavity of the subject.
[0092] FIGS. 12 through 15 depict a number of possible
configurations for structural elements of delivery devices for use
in body lumens. Structural elements may have the form of a short
cylinder 250, as shown in FIG. 12; an annulus 252, as shown in FIG.
13; a cylinder 254, as shown in FIG. 14; or a spiral 256, as shown
in FIG. 15. Elongated forms such as cylinder 254 or spiral 256 may
be suitable for use in generally tubular portions of
lumen-containing structures such as the nostrils, possibly with a
significant taper over their length (not shown in FIGS. 14-15).
Structural elements may be formed from various materials, including
metals, polymers, fabrics, and various composite materials,
including ones of either inorganic or organic character, the latter
including materials of both biologic and abiologic origin, selected
to provide suitable biocompatibility and mechanical properties.
[0093] As shown in FIGS. 16-18, the basic form of a structural
element may be subject to different variations, e.g., by
perforations, as shown in structural element 260 in FIG. 16; a mesh
structure, as shown in structural element 262 in FIG. 16; or the
inclusion of one or more slots 264 in structural element 266 in
FIG. 18. Slot 264 runs along the entire length of structural
element 266; in other embodiments, one or more slots (or mesh or
perforations) may be present in only a portion of the structural
element. By using spiral, mesh, or slotted structural elements (as
in FIGS. 15, 17, and 18) formed from resilient, elastic, springy or
self-expanding/self-contracting materials or substrates, suitable
structural elements may be formed. Spiral, mesh, or slotted
elements need not be elongated tubular structures as depicted in
FIGS. 15, 17, and 18, but may be shorter, generally ring-like
structures similar in profile to the structural element shown in
FIGS. 1 through 3, which is essentially a spring having only a
single loop.
[0094] A self-expanding or contracting structural element may
facilitate positioning or secure emplacement of the structural
element within a body lumen of an organism, such as a nasal
structure. In some embodiments, flexible material having adjustable
diameter, taper, and length properties may be used. For example,
some materials may change from a longer, narrower configuration 270
as shown in FIG. 19A, to a shorter, wider configuration 272 as
shown in FIG. 19B, or may taper over their length. Structural
elements that may exhibit this type of expansion/contraction
property may include mesh structures formed of various metals or
plastics, and some polymeric materials, for example.
[0095] The exemplary embodiments depicted in FIGS. 1-4 and 12-19B
either are substantially cylindrical, and hollow and tubular in
configuration, or ring-like, with a single central opening. Thus,
the exterior of the cylindrical or ring-like structural element may
contact and engage the wall of the body lumen, and the interior of
the structural element (within the single central opening) may form
a fluid-contacting portion of the structural element. Structural
elements are not limited to cylindrical or ring-like structural
elements having a single central opening, however.
[0096] FIGS. 20 through 25 depict a variety of cross-sectional
configurations for structural elements of delivery devices. Note
that the illustrated cross-sectional configurations are suitable to
be fit into a lumen having a roughly circular cross-section, as
would be the case, for example, with a nostril viewed from above or
below. Analogous structures may be designed to fit within lumens
having non-circular cross-sections. In FIG. 20, a delivery device
300 is positioned in lumen 302 of lumen-containing structure 304.
In this embodiment, fluid-contacting portion 306 may be the surface
of structural element 300 that faces lumen 302, while the
lumen-wall engaging portion 308 may be a layer of tissue adhesive
on surface 310 of structural element 300. An example of a device
having a cross-section similar to that shown in FIG. 20, is the
embodiment shown in FIGS. 10 and 11.
[0097] FIG. 21 depicts in cross-section a further embodiment of a
structural element 350 in lumen 352 of lumen-containing structure
354. Structural element 350 includes multiple openings 356, each of
which includes an interior surface 358 that forms a
fluid-contacting portion. Structural element 350 may include one or
more barb-like structures 360 that serve as lumen-wall engaging
portions that maintain structural element 350 in position with
respect to lumen-containing structure 354. Barb like structures may
be fixed in some embodiments, or retractable or moveable in other
embodiments.
[0098] FIG. 22 depicts in cross-section an embodiment of a
structural element 400 in lumen 402 of lumen-containing structure
404. Structural element 400 includes a large central opening 406
and multiple surrounding openings 408. The interior surface of each
opening 406 or 408 serves as a fluid-contacting portion, while
projections 410 function as lumen-wall engaging portions, which may
engage frictionally or may project slightly into the interior of
the wall of lumen-containing structure 404.
[0099] FIG. 23 depicts a further embodiment in which structural
element 450 has a substantially oval cross-section and includes a
slot 452. Lumen-containing structure 454 may be generally oval in
cross section, or may be flexible enough to be deformed to the
shape of structural element 450. Structural element 450 may be a
compressed spring-like structure that produces outward forces as
indicated by the black arrows, so that end portions 456 of
structural element 450 thus press against and engage the lumen
wall. Interior surface 458 of structural element 450 serves as the
fluid-contacting portion of structural element 450.
[0100] FIG. 24 is a cross-sectional view of a structural element
500 in a lumen-containing structure 502. Structural element 500
includes multiple projecting arms 504 which contact lumen wall 506
of lumen-containing structure 502, and function as lumen-wall
engaging portions. Inner surfaces 508 of arms 504 function as
fluid-contacting portions of structural element 500.
[0101] FIG. 25 depicts (in cross-section) another example of a
structural element 550 positioned within a lumen-containing
structure 552. Structural element 550 includes two openings 554.
The interior surfaces 556 of openings 554 function as
fluid-contacting portions, while the outer surface 558 of
structural element 550 serves as a lumen-wall engaging portion.
[0102] The structural elements depicted in FIGS. 1-25 are intended
to serve as examples, and are in no way limiting. The choice of
structural element size and configuration appropriate for a
particular body lumen may be selected by a person of skill in the
art. Structural elements may be constructed by a variety of
manufacturing methods, from a variety of materials. Appropriate
materials may include metals, ceramics, polymers, and composite
materials having suitable biocompatibility, sterilizability,
mechanical, and physical properties, as will be known to those of
skill in the art. Examples of materials and selection criteria are
described, for example, in The Biomedical Engineering Handbook,
Second Edition, Volume I, J. D. Bronzino, Ed., Copyright 2000, CRC
Press LLC, pp. IV-1-43-31. Manufacturing techniques may include
injection molding, extrusion, die-cutting, rapid-prototyping, or
self-assembly, for example, and will depend on the choice of
material and device size and configuration. Sensing and active
portions of the delivery device as well as associated electrical
circuitry may be fabricated on the structural element using various
microfabrication and/or MEMS techniques, or may be constructed
separately and subsequently assembled to the structural element, as
one or more distinct components.
[0103] In a controllable release nasal device or system, a fluid
contacting portion typically contacts inspired or expired air/gases
moving through the nasal region, while a lumen wall engaging
portion may contact the tissue lining the wall of the nostril or
the nasal cavity. In some embodiments, the lumen wall-engaging
portion may closely contact the nasal mucosa, and/or may be in
proximity to capillary beds in the nasal mucosa. In some
embodiments of a controllable release nasal device or system, a
lumen wall engaging portion may be in proximity to neural tissue in
the olfactory region. Contact with or proximity to mucosa,
capillaries, and/or neural tissue by the lumen wall engaging
portion of a controllable release nasal device or system may
facilitate the release or transfer of material to some or all of
these tissues by a delivery portion located on the lumen wall
engaging portion, or the sensing of various parameters regarding or
pertinent to these tissues by a sensing portion. Similarly, contact
or proximity of a fluid-contacting portion of a controllable
release nasal device or system to a fluid mixture (i.e., gases,
fine particles, liquid droplets, etc.) within the nostrils or nasal
cavity may facilitate the release of materials into the fluid
mixture by a delivery portion located on the fluid-contacting
portion, or the sensing of various parameters pertinent to the
fluid mixture by a sensing function.
[0104] The delivery portion may be configured to release the at
least one material directly into the nasal mucosa for absorption in
some embodiment, as illustrated in FIG. 26. Structural element 600,
which is similar to that depicted in FIGS. 10 and 11, may be
positioned against nasal mucosa 602 on the surface of nasal septum
40, so that delivery portion 604 is positioned adjacent to nasal
mucosa 602. Material 606 released from delivery portion 604 may
then be absorbed into nasal mucosa 602. Control signal generation
circuitry 608 on structural element 600 may generate a control
signal that stimulates release of material 606 from delivery
portion 604. In some such embodiments, the delivery portion may
include a permeation enhancer (that may be released in association
with the material being delivered, for example) that is capable of
increasing the permeation of the at least one material into the
nasal mucosa. Permeation enhancers may include chemical permeation
enhancers such as isopropyl myristate, bile salts, surfactants,
fatty acids and derivatives, chelators, cyclodextrins or chitosan,
as described in Murthy, S. N. Hiremath, S. R. R. "Physical and
Chemical Permeation Enhancers in Transdermal Delivery of
Terbutaline Sulphate," AAPS PharmSciTech., 2001, 2(1) or Senel, S.
Hincal, A. A. "Drug permeation enhancement via buccal route:
possibilities and limitations," J. Control Release, 2001 May 14,
72(1-3):133-44, both of which are incorporated herein by reference.
Permeation may also be enhanced by including a magnetic component,
as described in Murthy, S. N., Hiremath, S. R. R. "Physical and
Chemical Permeation Enhancers in Transdermal Delivery of
Terbutaline Sulphate," AAPS PharmSciTech., 2001, 2(1), or by the
use of microprotrusions of the type described in U.S. Pat. No.
6,953,589, or other microneedles or microfine lances. The foregoing
references are incorporated herein by reference. Other technologies
that may used for enhancing permeability of materials include, but
are not limited to, iontophoresis, microdialysis, ultrafiltration,
electromagnetic, osmotic, electroosmosis, sonophoresis,
microdialysis, suction, electroporation, thermal poration,
microporation, microfine cannulas, skin permeabilization, or a
laser.
[0105] As illustrated in FIG. 27, in other embodiments, the
delivery portion may be configured to release the at least one
material into the nasal cavity in the form of a spray or similar
aero-suspension of finely dispersed particles, powders or droplets.
In FIG. 27, delivery device 620 includes structural element 622
similar to structural element 160 in FIGS. 8 and 9. Delivery
portion 624 of delivery device 620 is configured to direct the
release of the at least one material 626 toward the nasal mucosa,
e.g. in the interior of nasal cavity 20. In other embodiments, as
shown in FIG. 28, delivery device 650 may include delivery portion
652 configured to direct the release of the at least one material
654 toward the olfactory portion 656 of the nasal mucosa. In still
other embodiments, as shown in FIG. 29, a delivery device 670 may
include a delivery portion 672 configured to direct the release of
the at least one material 674 toward the nasopharynx 22. Material
directed toward nasopharynx may subsequently be inhaled into the
other portions of the respiratory tract, including the lungs, of
the person in which delivery device 670 is emplaced, and it may be
configured for preferential delivery to or deposition onto one or
more surfaces of particular portions thereof.
[0106] In other embodiments, the active portion of a delivery
device may include a material release structure operatively coupled
to the response initiation circuitry and configured to release a
material in response to detection of a condition of interest. A
condition of interest may be detected by a sensor, which may be
located in or on the release delivery device.
[0107] FIG. 30 depicts a delivery device 700 including a structural
element 702, sensor 704, control signal generation circuitry 706,
and release structure 708 including release mechanism 710.
Structural element 702 includes external surface 712, configured to
fit within a body lumen, and internal surface 714 defining central
opening 716, through which a fluid may flow. Upon sensing of a
condition of interest in the fluid by sensor 704, control signal
generation circuitry 706 may cause release of material from
material release structure 708 by activating release mechanism 710.
Release mechanism 710 may include a variety of different types of
release mechanisms, including, for example a controllable valve as
depicted in FIG. 30. Various types of valves and microvalves are
known to those of skill in the art, and may be used to regulate the
release of material from material release structure 708 in response
to a control signal from control signal generation circuitry 706.
Control signal generation circuitry 706 may activate release
mechanism 710 by supplying a delivery control signal, which may be
an electrical signal, for example. In some embodiments, other types
of delivery control signals, including magnetic signals, optical
signals, acoustic signals, or other types of signals may be used.
Combinations of several types of signals may be used in some
embodiments. In some embodiments, control signal generation
circuitry 706 may cause release of material from material release
structure in response to passage of a certain amount of time, as
monitored, for example, by a timekeeping device. In some
embodiments, material release structure 708 may include a
pressurized reservoir of material. In still other embodiments, the
material (or materials) to be released may be generated within the
material release structure. In other embodiments, the material(s)
may diffuse away from the release structure along a concentration
gradient.
[0108] In some embodiments, the system may include an extension
connected to the structural element, wherein the structural element
is mounted with a first portion of the nasal region of the subject,
and wherein the extension extends from the structural element to a
second portion of the nasal region to deliver the at least one
material to the second portion of the nasal region. FIG. 31
illustrates an embodiment of a delivery device including a
structural element 720 mounted in a nostril 18 of a person 11 by
means of clip 722. Structural element 720 also includes extension
724 that project toward a more internal portion of the nasal
region, which in this example is olfactory mucosa 38, where it
releases material from end portion 726. End portion 726 may be the
opening of a tubular structure connected to a material source in
structural element 720, or end portion 726 may be a release
location for a material source located at end portion 726. Other
embodiments of delivery devices may include extensions configured
to deliver material(s) to other portions of the nasal region, while
the main part of the delivery device resides in a relatively
accessible location, for example, the nostril.
[0109] FIG. 32 illustrates, in cross sectional view, a structural
element 750 of a delivery device positioned in a lumen-containing
structure 752. A reservoir 754 contains stored deliverable
material. Barrier 756 is a controllable barrier that controls the
release of the stored deliverable material into central opening
758, and thus into a fluid that fills and/or flows through
lumen-containing structure 752. Various types of barriers may be
used to control the release of material from the delivery portion
of the controllable release nasal system. For example, the delivery
portion may include a rupturable barrier, a barrier having a
controllable permeability, a stimulus-responsive gel or polymer, or
a pressurized fluid source.
[0110] FIG. 33 illustrates an embodiment including a structural
element 800 of a delivery device positioned in a lumen-containing
structure 802. Two reservoirs 804 contain stored deliverable
material(s). Each reservoir 804 includes a controllable barrier 806
that controls release of the at least one stored deliverable
material. In the embodiment of FIG. 33, activation of barrier 806
causes release of the at least one stored deliverable material
toward the lumen wall of lumen-containing structure 802, rather
than into central opening 808. FIG. 33 also illustrates that
delivery devices may include more than one reservoir.
[0111] FIGS. 34A, 34B, 35A, 35B, 36A and 36B, illustrate several
alternative embodiments of material release structures that include
controllable barriers. In FIGS. 34A and 34B, release structure 850
includes reservoir 852 containing stored deliverable material 854.
As shown in FIG. 34A, while rupturable barrier 856 is intact,
stored deliverable material 854 is contained within reservoir 852.
As shown in FIG. 34B, when rupturable barrier 856 has been ruptured
(as indicated by reference number 856'), deliverable material 854
may be released from reservoir 852. Rupturable barrier 856 may be
ruptured by an increase of pressure in reservoir 852 caused by
heating, for example, which may be controlled by response
initiation circuitry. In another alternative shown in FIGS. 35A and
35B, release structure 900 includes reservoir 902 containing stored
deliverable material 904. As shown in FIG. 35A, while degradable
barrier 906 is intact, stored deliverable material 904 is contained
within reservoir 902. As shown in FIG. 35B, degradation of
degradable barrier 906 to degraded form 906' causes stored
deliverable material 904 to be released from reservoir 902. FIGS.
36A and 36B depict release structure 950 including reservoir 952
containing stored deliverable material 954. FIG. 36A, shows barrier
956, which has a controllable permeability, in a first, impermeable
state, while FIG. 36B shows barrier 956 in a second, permeable
state (indicated by reference number 956'). Stored deliverable
material 954 passes through barrier 956', when it is in its
permeable state, and is released. Rupturable barriers as described
above may be formed from a variety of materials, including, but not
limited to, metals, polymers, crystalline materials, glasses,
ceramics, semiconductors, etc. Release of materials through rupture
or degradation of a barrier is also described in U.S. Pat. No.
6,773,429, which is incorporated herein by reference. Semipermable
barriers having variable permeability are described, for example,
in U.S. Pat. No. 6,669,683, which is incorporated herein by
reference. Those of skill in the art will appreciate that barriers
can be formed and operated reversibly through multiple release
cycles, in addition to the single-release functionality available
from a rupturable barrier.
[0112] In some embodiments, a delivery device may include one or
more stored deliverable materials dispersed in a carrier material.
Stored deliverable material may be released from the carrier
material by a release mechanism upon activation of the release
mechanism. The released deliverable material may be released into a
central opening of a delivery device and/or into the body lumen.
FIGS. 37A and 37B depict in greater detail the release of stored
deliverable material from the carrier material. In FIG. 37A,
deliverable material 1024 is stored in carrier material 1026.
Carrier material 1026 may be, for example, a polymeric material
such as a hydrogel, and deliverable material is dispersed or
dissolved within carrier material 1026. Release mechanism 1028 may
be a heating element, for example a resistive element connected
directly to response initiation circuitry, or an electrically or
magnetically responsive material that may be caused to move,
vibrate, heat, by an externally applied electromagnetic field,
which in turn causes release of deliverable material 1024 from
carrier material 1026, as shown in FIG. 29B. See, for example, U.S.
Pat. Nos. 5,019,372 and 5,830,207, which are incorporated herein by
reference. In some embodiments, an electrically or magnetically
active component may be heatable by an electromagnetic control
signal, and heating of the electrically or magnetically active
component may cause the polymer to undergo a change in
configuration. An example of a magnetically responsive polymer is
described, for example, in Neto, et al, "Optical, Magnetic and
Dielectric Properties of Non-Liquid Crystalline Elastomers Doped
with Magnetic Colloids"; Brazilian Journal of Physics; bearing a
date of March 2005; pp. 184-189; Volume 35, Number 1, which is
incorporated herein by reference. Other exemplary materials and
structures are described in Agarwal et al., "Magnetically-driven
temperature-controlled microfluidic actuators"; pp. 1-5; located
at:
http://www.unl.im.dendai.ac.jp/INSS2004/INSS2004_papers/OralPresentations-
/C2.pdf or U.S. Pat. No. 6,607,553, each of which is incorporated
herein by reference. Other examples of stimulus-responsive gels or
polymers are substance-responsive gels or polymers that swell,
change shape, etc. in response to a change in pH, glucose, or other
substance (as selected by embedded antibodies, for example).
Examples of stimulus responsive gels or polymers are described in
Langer, R. & Peppas, N., "Advances in Biomaterials, Drug
Delivery, and Bionanotechnology," AIChE Journal, December 2003,
Vol. 49, No. 12, pp. 2990-3006, which is incorporated herein by
reference.
[0113] The controllable release nasal system may include a source
of the material located in or on the structural element, as
depicted generally in FIGS. 30-36B (e.g., either as a reservoir
containing the material as shown in FIGS. 34A-36B, or as a portion
of carrier material containing a dispersed or dissolved material,
as shown in FIGS. 37A and 37B. Alternatively, a controllable
release nasal system may include a source of material located
external to the nasal region of the subject and connected to the
delivery portion via a delivery tube that enters the nasal region
of the subject via a nostril of the subject, as shown in FIG.
38
[0114] In FIG. 38, structural element 1050 includes a clip-like
structure that fits onto nasal septum 40, with end regions 1052
projecting into at least one nostril 18, which end-regions may
include at-least-one sensor (not shown). Material to be delivered
may be supplied from supply reservoir 1054 via supply tube 1056. A
control device 1058 including control signal generation circuitry
1059 may control the flow of material (e.g., a gas or gaseous
mixture, possibly carrying fluid droplets or fine solid particles)
from supply reservoir 1054 to supply tube 1056 and thence into
nostrils 18. Supply reservoir 1054 may be a tank capable of
containing the material in liquid or gaseous form, or it may
contain a solid source which releases material upon heating, change
in pressure, or a chemical reaction, for example. In some
embodiments, a carrier gas or liquid may be stored in supply
reservoir 1054, and one or more active component of the material
may be added from a secondary source that may be regulated by
control device 1058, for example.
[0115] FIG. 39 is a detailed cross-sectional view of structural
element 1050 of the embodiment shown in FIG. 38. Supply tube 1056
fits over stem portion 1060 of structural element 1050. Channel
1062 in supply tube 1056 aligns with channel 1064 in structural
element 1050. Channel 1064 connects to branch channels 1066 and
1068, which lead to openings 1070 and 1072, respectively. Material
may be delivered to the one-or-both nostrils via openings 1070 and
1072. Structural element 1050 also includes sensors 1074 and 1076,
which are connected to leads 1078 and 1080, respectively. Leads
1078 and 1080 are connected to leads 1082 and 1084, respectively in
supply tube 1056 via contacts 1086 and 1088 in structural element
1050 and corresponding contacts 1090 and 1092 in supply tube 1056.
Leads 1082 and 1084 connect sensors 1074 and 1076 to control signal
generation circuitry (e.g., control signal generation circuitry
1059 as shown in FIG. 38), where they may serve to provide feedback
signals which may be used in the determination of a delivery
control signal for controlling the delivery of the material.
Sensors 1074 and 1076 may be any of various types of sensors, as
are known to those of skill in the art, for example, gas sensors,
temperature sensors, flow sensors, pressure sensors, moisture
sensors, straing sensors, acoustic sensors, chemical-composition or
-concentration sensors, or other types of sensors as described
elsewhere herein. Sensors 1074 and 1076 may be positioned on
structural element 1050 in such a manner that they contact the
nasal wall or septum, to sense a parameter of the nasal tissue, or
they may be positioned on structural element 1050 in such a way
that they sense a parameter from a fluid (gas and/or liquid) within
the nostril or nasal cavity.
[0116] The delivery portion of the controllable release nasal
device or system may deliver a material to a nasal region or a
portion thereof by diffusion or low-speed dispersion of the
material from the delivery portion (e.g., as depicted in FIG. 26)
or it may deliver the material in a spray or jet, as depicted in
FIGS. 27 through 29. In some embodiments, the system may rely upon
fluid (air/liquid) movement or pressure changes associated with
breathing activity to move or distribute the delivered material to
the intended destination(s). FIG. 26 provides an example of an
embodiment that relies upon diffusion or dispersion of the material
into tissue. FIGS. 27 through 29 and 38 depict examples of
embodiments in which the material may be delivered under pressure.
For example, supply reservoir 1054 may be a pressurized tank. In
other embodiments, the material may not be stored under pressure,
but may have its pressure or speed-of-movement increased at the
time of delivery by heating, for example.
[0117] FIG. 40 is a schematic diagram of a controllable release
nasal system 1100 as described generally herein. Controllable
release nasal system 1100 may include some or all of structural
element 1102, positioning portion 1104, control signal generation
circuitry 1106, delivery portion 1108, material source 1110, and
power source 1112, as well as a sensing function (not shown
explicitly).
[0118] FIG. 41 is a block diagram illustrating in greater detail
various circuitry components of a controllable release nasal
system. Circuitry components may include electrical circuitry
components, or, alternatively or in addition, fluid circuitry,
optical circuitry, biological or chemical circuitry,
chemo-mechanical circuitry, and/or other types of circuitry in
which information is carried, transmitted, and/or manipulated by
non-electronic means. The controllable release nasal system may
include one or more sensors 1150 for measuring or detecting a
condition of interest. Sensing circuitry 1152 may be associated
with sensors 1150. The controllable release nasal system may
include various control circuitry 1154, including control signal
generation circuitry 1156. Control signal generation circuitry 1156
provides a delivery control signal to delivery portion 1158.
Delivery portion may receive a material to be delivered from
material source 1160. Control circuitry 1154 may also include data
storage portion 1162, which may, for example, be used to store
pattern data 1164 or pattern parameters 1166. Data storage portion
1162 may also be used to store sense data 1168 and/or sense
parameters 1170, which may be derived from a sense signal, e.g. by
sensing circuitry 1152. Control electronics may include data
transmission/reception circuitry 1172, which provides for the
transmission and reception of data and/or power signals between the
delivery device and remote circuitry 1174. User interface circuitry
1176 may receive input signals from user input device 1178. User
input device 1178 may provide for the input of user instruction,
parameter, etc. to control circuitry 1154. Finally, one or more
power sources 1180 may provide power to circuitry and other
components of the controllable release nasal system.
[0119] The control signal generation circuitry, and control
circuitry in general, may include a microprocessor and/or at least
one of hardware, software, and firmware. The control signal
generation circuitry may be configured to generate a delivery
control signal based upon a pre-determined delivery pattern, in
which case the system may also include a memory location for
storing the pre-determined delivery pattern (e.g., pattern data
1164 stored in data storage portion 1162). In some embodiments, the
control signal generation circuitry may be configured to calculate
a delivery control signal based upon one or more stored parameters.
Again, the system may include a memory location for storing the one
or more parameters (e.g., pattern parameters 1166 or sense
parameters 1170 stored in data storage portion 1162). For example,
the control signal generation circuitry may be configured to
generate a delivery control signal corresponding to a pattern of
delivery of the at least one material expected to produce a
therapeutic effect or a sensory effect. In some embodiments, the
control signal generation circuitry may be configured to generate a
delivery control signal corresponding to a pattern of delivery of
the at least one material expected to produce a therapeutic effect
tailored specifically to the subject. For example, the control
signal generation circuitry may be configured to generate a
delivery control signal taking into account parameters such as the
size, weight, gender, age, as well as specifics relating to the
subject's preferences, medical condition or other parameters.
[0120] Circuitry components as discussed in connection with FIG. 41
may be located entirely on the structural element of a delivery
device portion of a controllable release nasal system, or may be
distributed between the delivery device and a remote portion as
depicted in FIG. 42. In FIG. 42, a delivery device 1200 is
positioned in nasal region 12 of head 10 of a person 11. Remote
portion 1102 may be held by person 11, or otherwise positioned
nearby person 11. For example, remote portion 1202 may be carried
or attached to a wristband or necklace. Remote portion 1102 may
transmit signal 1204 to delivery device 1200. Signal 1204 may be a
one- or two-way signal, containing control, data, or power signals.
In some embodiments, remote portion 1202 may permit person 11 to
provide user input to specify delivery of material to nasal region
12 with delivery device 1200.
[0121] Alternatively, in some embodiments, control signal
generation circuitry may be located remote from the structural
element and associated with a transmitting structure capable of
transmitting the delivery control signal to the structural element,
and wherein the delivery portion is associated with a receiving
structure capable of receiving the delivery control signal. FIG. 43
is a block diagram of a controllable release nasal system including
a delivery device 1220 and remote portion 1222. Delivery device
1220 may include various components as depicted in FIG. 41,
including (but not limited to) control circuitry 1224, delivery
portion 1226, and one or both of a power receiver 1228 and data
receiver/transmitter 1230. In some embodiments, data
receiver/transmitter 1230 may only receive data signals, while in
other embodiments it may only transmit data signals, and in still
other embodiments it may both transmit and receive data signals.
Power receiver 1228 may receive power signals transmitted from
remote portion 1222. Remote portion 1222 may include one or both of
power source 1232 and control signal generator 1234. Power
transmitter 1236 may be used in connection with power source 1232
in order to transmit power to power receiver 1228 in delivery
device 1220. Data transmitter/receiver 1238 may transmit a delivery
control signal from control signal generator 1234 to delivery
device 1220, or receive sense or parameter data signals transmitted
from delivery device 1220 by data receiver/transmitter 1230. In
some embodiments of the system, the control signal generation
circuitry may be a part of the delivery device, located in or on
the structural element.
[0122] In some embodiments of delivery devices or systems, a
delivery device may be a self-contained device that may be
positioned in a body lumen and that includes all functionalities
necessary for operation of the device. In other embodiments, as
shown in FIGS. 42 and 43, a controllable release nasal system may
include a delivery device that may be placed in a nasal region, and
a remote portion that includes a portion of the functionalities of
the controllable release nasal system. In some embodiments, all
functionalities essential for the operation of the delivery device
may be located on the delivery device, but certain auxiliary
functions may be located in the remote portion. For example, the
remote portion may provide for monitoring of the operation of the
delivery device or data collection or analysis. The remote portion
may be located within the body of the subject at a distance from
the delivery device, or outside the body of the subject, as
depicted in FIG. 42, either proximate to or distant from it. Data
and/or power signals may be transmitted between delivery device and
remote portion with the use of electromagnetic or acoustic signals,
or, in some embodiments, may be carried over electrical or optical
links. In general, the remote portion may be placed in a location
where there is more space available than within the body lumen,
that is more readily accessible, and so forth. It is contemplated
that a portion of the circuitry portion of the controllable release
nasal system (which may include hardware, firmware, software, or
any combination thereof) may be located in a remote portion.
Methods of distributing functionalities of a system between
hardware, firmware, and software located at two or more sites are
well known to those of skill in the art. The control circuitry
portion of the controllable release nasal system may include, but
is not limited to, electrical circuitry associated with the sensor,
response initiation circuitry, and electronics associated with the
active portion.
[0123] In various embodiments, the system may include a power
source such as a battery. A power source may also be considered to
include a power receiver capable of receiving inductively coupled
power from an external power source, e.g., as depicted in FIG. 43.
Delivery devices and systems according to various embodiments as
described herein may include a power source, such as one or more
batteries located on the delivery device, possibly a microbattery
like those available from Quallion LLC (http://www.quallion.com) or
designed as a film (U.S. Pat. Nos. 5,338,625 and 5,705,293), which
are incorporated herein by reference. Batteries may include primary
or secondary batteries, including various types of electrochemical
energy storage devices. In some embodiments, the power source may
be one or more fuel cell such as an enzymatic, microbial, or
photosynthetic fuel cell or other biofuel cell (US20030152823A1;
WO03106966A2, and "A Miniature Biofuel cell"; Chen, T. et al., J.
Am. Chem. Soc., Vol. 123, pp. 8630-8631, 2001, all of which are
incorporated herein by reference), and could be of any size,
including the micro- or nano-scale. In some embodiments, the power
source may be a nuclear battery. The power source may be any of
various mechanical energy storage devices, including but not
limited to pressurized bladders or reservoirs, wind-up and
spring-loaded devices. The power source may be an energy-scavenging
device such as a pressure-rectifying mechanism that utilizes
pulsatile changes in blood pressure, for example, or an
acceleration-rectifying mechanism as used in self-winding watches;
it may derive energy from the cyclic flow of gas through the upper
airway. In some embodiments, the power source may be an electrical
power source located remote from the structural element and
connected to the structural element by a wire, or an optical power
source located remote from the structural element and connected to
the structural element by a fiber-optic line or cable. In some
embodiments, the power source may be a power receiver capable of
receiving power from an external source, acoustic energy from an
external source, a power receiver capable of receiving
electromagnetic energy (e.g., microwave, infrared or optical
electromagnetic energy) from an external source.
[0124] The control signal generation circuitry may include at least
one of hardware, software, and firmware; in some embodiments the
control signal generation circuitry may include a microprocessor or
a (programmable) logic array. The control signal generation
circuitry may be located in or on the structural element in some
embodiments, while in other embodiments the response initiation
circuitry may be at a location remote from the structural
element.
[0125] FIG. 44 depicts a controllable release nasal device 1300
including a sensor 1302 capable of detecting a parameter of
interest in the nasal region of the subject. Controllable release
nasal device 1300, may include sensor 1302, control signal
generation circuitry 1304, and delivery portion 1306. The control
signal generation circuitry may be configured to modulate
generation of the delivery control signal based upon at least one
parameter of interest sensed by the sensor. Controllable release
nasal device may be positioned on nasal septum 40, with delivery
portion 1306 located against the nasal mucosa 32. Sensor 1302 may
sense a parameter from the tissue (for example, a chemical
parameter such as a glucose concentration, a heart rate or blood
pressure parameter, or a temperature, among others). Control signal
generation circuitry 1304 may generate a delivery control signal
based upon a sense signal received from sensor 1302. The delivery
control signal may be provided to delivery portion 1306, to drive
delivery of material 1308.
[0126] In the controllable release nasal device depicted in FIG.
44, both sensor 1302 and delivery portion 1306 are positioned
adjacent to nasal mucosa 32. FIGS. 45, 46 and 47 depict other
possible configurations for sensors and delivery portions of
controllable release nasal devices. FIGS. 45 through 47 are
cross-sectional views of a controllable release nasal device in a
nostril. In FIG. 45, sensor 1350 is positioned on structural
element 1352 so as to be positioned adjacent to the nasal mucosa 32
when structural element 1352 is mounted within the nasal region of
the subject. Delivery portion 1354 is positioned adjacent lumen
1356 of structural element 1352, away from nasal mucosa 32. Control
signal generation circuitry 1358 is also indicated. Alternatively,
as shown in FIG. 46, sensor 1350 may be positioned on structural
element 1352 so as to be positioned adjacent to lumen 1356 when
structural element 1352 is mounted within the nasal region of the
subject. In still other embodiments, as illustrated in FIG. 47,
both sensor 1350 and delivery portion 1354 may be positioned
adjacent to lumen 1356 when structural element 1352 is mounted
within the nasal region of the subject.
[0127] Sensors used in the various embodiments described herein
(e.g., sensors 1074 and 1076 in FIG. 39, sensor 1302 in FIG. 44, or
sensor 1350 in FIGS. 45-47) may be of various types, including, for
example pressure sensors, temperature sensors, flow sensors, or
chemical sensors, for example. Sensors may be used to detect a
condition of interest in the fluid (e.g. gas and/or liquid droplets
or small solid particles) within a lumen of the nasal cavity (or
lumen of a delivery device continuous therewith), or in tissue
surrounding the lumen, which may include, for example, detecting
pressure, temperature, fluid flow, presence of a cell of interest,
or concentration of a chemical or chemical species (including ionic
species) of interest. A sensor may sense a wide variety of physical
or chemical properties. In some embodiments, detecting a condition
of interest may include detecting the presence (or absence) of a
material or structure of interest in the fluid. A sensor may
include one or more of an optical sensor, an imaging device, an
acoustic sensor, a pressure sensor, a temperature sensor, a flow
sensor, a viscosity sensor, or a shear sensor for measuring the
effective shear modulus of the fluid at a frequency or strain-rate,
a chemical sensor for determining the concentration of a chemical
compound or species, a biosensor, or an electrical sensor, for
example. An optical sensor may be configured to measure the
absorption, emission, fluorescence, or phosphorescence of at least
a portion of the fluid, for example. Such optical properties may be
inherent optical properties of all or a portion of the fluid, or
may be optical properties of materials added or introduced to the
fluid, such as tags or markers for materials of interest within the
fluid. A biosensor may detect materials including, but not limited
to, a biological marker, an antibody, an antigen, a peptide, a
polypeptide, a protein, a complex, a nucleic acid, a cell or cell
fragment (and, in some cases, a cell of a particular type, e.g. by
methods used in flow cytometry), a cellular component, an
organelle, a pathogen, a lipid, a lipoprotein, an alcohol, an acid,
an ion, an immunomodulator, a sterol, a carbohydrate, a
polysaccharide, a glycoprotein, a metal, an electrolyte, a
metabolite, an organic compound, an organophosphate, a drug, a
therapeutic, a gas, a pollutant, or a tag. A biosensor may include
an antibody or other reasonably specific binding molecule such as a
receptor or ligand. A sensor may include a single sensor or an
array of sensors, and is not limited to a particular number or type
of sensors. A sensor might comprise in part or whole, a gas sensor
such as an acoustic wave, chemiresistant, or piezoelectric sensor,
or perhaps an "electronic nose". A sensor may be very small,
comprising a sensor or array that is a chemical sensor ("Chemical
Detection with a Single-Walled Carbon Nanotube Capacitor", E. S.
Snow, Science, Vol. 307, pp. 1942-1945, 2005.), a gas sensor
("Smart single-chip gas sensor microsystem", Hagleitner, C. et al.,
Nature, Vol. 414 pp. 293-296, 2001.), an electronic nose, a nuclear
magnetic resonance imager ("Controlled multiple quantum coherences
of nuclear spins in a nanometre-scale device", Go Yusa, Nature,
Vol. 343: pp. 1001-1005, 2005). Further examples of sensors are
provided in The Biomedical Engineering Handbook, Second Edition,
Volume I, J. D. Bronzino, Ed., Copyright 2000, CRC Press LLC, pp.
V-1-51-9, and U.S. Pat. No. 6,802,811, both of which are
incorporated herein by reference. A sensor may be configured to
measure various parameters, including, but not limited to, the
electrical resistivity of the fluid, the density or sound speed of
the fluid, the pH, the osmolality, or the index of refraction of
the fluid at least one wavelength, as well as its temperature,
water content and chemical composition. The selection of a suitable
sensor for a particular application or use site is considered to be
within the capability of a person having skill in the art. In some
applications, detecting a condition of interest in the fluid may
include detecting the presence of a material of interest in the
fluid (gas and/or liquid) within a nasal lumen. A material of
interest in a fluid may include, dust particle, a pollen particle,
a pathogen, or parasite, or a cell, cellular component, or
collection or aggregation of cells or components thereof.
[0128] A controllable release nasal device may include an active
portion which may perform an action in the nasal cavity in addition
to or instead of the material release function performed by the
release portion described herein. A release portion is an exemplar
of an active portion. A number of active portions are described,
for example, in U.S. patent application Ser. No. 11/403,230,
entitled "Lumenally Active Device" and filed Apr. 12, 2006, which
is incorporated herein by reference above.
[0129] In connection with detection of the presence of a material
of interest, for example, an active portion of the controllable
release nasal system may be capable of removing, modifying, or
destroying the material of interest. Modification or destruction of
the material of interest may be accomplished by the release of a
suitable material (e.g. an endopeptidatse for killing bacteria, or
an anti-inflammatory, biomimetic, or biologic to bind to and
inactivate an inflammatory mediator such as histamine or an
immunoglobulin), by the delivery of suitable energy (e.g., acoustic
energy, electromagnetic energy such as light to cause a
photoreaction, break bonds in a molecule, produce heating, etc., or
by delivery of heat or cold or other chemo-physical change (e.g.
ambient pressure, pH, osmolality, toxic material
introduction/generation) for tissue modification or ablation.
[0130] FIGS. 48 through 55 illustrate examples of different active
portions which may be included in a controllable release nasal
device or system. The active portion may include a heating element
1400 as depicted in FIG. 48, operatively coupled to the response
initiation circuitry 1401 and configured to produce heating in
response to detection of the condition of interest. The heating
element may be a resistive element that produces heat when current
is passed through it, or it may be a magnetically active material
that produces heat upon exposure to an electromagnetic field.
Examples of magnetically active materials include permanently
magnetizable materials, ferromagnetic materials such as iron,
nickel, cobalt, and alloys thereof, ferrimagnetic materials such as
magnetite, ferrous materials, ferric materials, diamagnetic
materials such as quartz, paramagnetic materials such as silicate
or sulfide, and antiferromagnetic materials such as canted
antiferromagnetic materials which behave similarly to ferromagnetic
materials; examples of electrically active materials include
ferroelectrics, piezoelectrics and dielectrics.
[0131] Alternatively, the active portion may include a cooling
element 1402 as depicted in FIG. 49, operatively coupled to the
response initiation circuitry 1403 and configured to produce
cooling in response to detection of the condition of interest.
Cooling may be produced by a number of mechanisms and/or
structures. For example, cooling may be produced by an endothermic
reaction (such as the mixing of ammonium nitrate and water)
initiated by opening of a valve or actuation of a container in
response to a control signal. Other methods and/or mechanisms of
producing cooling may include, but are not limited to,
thermoelectric (e.g., Peltier Effect) and liquid-gas-vaporization
(e.g., Joule-Thomson) devices.
[0132] In some embodiments, the active portion may include an
electromagnetic radiation source 1404 as depicted in FIG. 50,
operatively coupled to the response initiation circuitry 1405 and
configured to emit electromagnetic radiation in response to
detection of the condition of interest. Electromagnetic radiation
sources may include light sources, for example, such as light
emitting diodes and laser diodes, or sources of other frequencies
of electromagnetic energy or radiation, radio waves, microwaves,
ultraviolet energy, infrared energy, optical energy, terahertz
radiation, and the like. In some embodiments, the active portion
may include an electric field source or a magnetic field
source.
[0133] As another alternative, the active portion may include an
acoustic energy source 1406 (e.g., a piezoelectric crystal) as
depicted in FIG. 51, operatively coupled to the response initiation
circuitry 1407 and configured to emit acoustic energy in response
to detection of the condition of interest. The active portion may
include a pressure source operatively coupled to the response
initiation circuitry and configured to apply pressure to a portion
of the body lumen in response to detection of the condition of
interest. Pressure sources may include materials that expand
through absorption of water, or expand or contract due to
generation or consumption of gas or conformation change produced by
chemical reactions or temperature changes, electrically-engendered
Maxwell stresses, osmotic stress-generators, etc. FIG. 52 depicts a
negative pressure source 1450 capable of applying negative pressure
(in this example, substantially radially-inward force) to lumen
walls 1451, while FIG. 53 depicts a positive pressure (expanding or
expansion) source 1452, capable of applying positive pressure (in
this example, a substantially radially-outward force) to lumen
walls 1451.
[0134] Alternatively, or in addition, in some embodiments the
active portion may include a capture portion operatively coupled to
the response initiation circuitry and configured to capture the
detected material of interest. FIG. 54 depicts a device 1500
including a fluid capture portion 1506. Delivery device 1500
includes sensor 1502, response initiation circuitry 1504, and fluid
capture portion 1506. Fluid enters fluid capture portion 1506 via
inlet 1508. Fluid capture portion 1506 may be a reservoir, for
example, into which fluid is drawn by capillary action.
Alternatively, fluid may be pumped into capture portion 1506.
Captured fluid may be treated and released, or simply stored. In
some applications, stored fluid may be subjected to analysis.
[0135] FIG. 55 depicts delivery device 1550 including a sample
collection structure 1552 capable of collecting a solid sample
1554. In the example depicted in FIG. 55, solid sample 1554 is a
solid material found upon or immediately under the surface of the
lumen-defining wall 1556 (a nasal polyp or inflammed tissue biopsy
sample, for example). Solid sample 1554 placed in storage reservoir
1558 by sample collection structure 1552. In a related alternative
embodiment, a delivery device may include a filter or selective
binding region to remove materials from fluid moving past or
through the delivery device.
[0136] FIG. 56 is a flow diagram of a method of delivering a
material to the nasal region of a subject. As indicated at 1602,
the method may include the step of releasing at least one material
from a delivery portion of a delivery device mounted within a nasal
region of a subject in response to a delivery control signal
corresponding to a desired release pattern.
[0137] The method may include including transmitting information
relating to the operation of the delivery device to a remote
location, which may include, for example, information relating to
the delivery of material by the delivery device. The method may
include transmitting information relating to one or more sensed
values of the parameter of interest to a remote location.
[0138] As shown in FIG. 57, in addition to releasing at least one
material from a delivery portion of a delivery device mounted
within a nasal region of a subject in response to a delivery
control signal corresponding to a desired release pattern at 1654,
the method may include the additional steps of sensing at least one
parameter of interest in the nasal region with a sensor in the
delivery device at 1652, and controlling the release of the at
least one material based upon the value of the at least one
parameter of interest at 1656.
[0139] The method may include sensing the at least one parameter of
interest from tissue in the nasal region, as shown at 1660, sensing
the at least one parameter of interest from blood in the nasal
region, as shown at 1662, or sensing the at least one parameter of
interest from a gas or gaseous mixture within a nasal cavity or
nostril, as shown at 1664.
[0140] As shown in FIG. 58, other method steps may include a number
of alternative method steps for generating a delivery control
signal. As shown at step 1702, the method may include generating
the delivery control signal with a control signal generation
circuitry in a remote device and transmitting the delivery control
signal to the delivery device. Alternatively, as shown at step
1704, the method may include generating the delivery control signal
with control signal generation circuitry in the delivery device, or
generating the delivery control signal with control signal
generation circuitry located at least in part at a location remote
from the delivery portion of the delivery device, shown at step
1706. Any of steps 1702 through 1706 may be followed by a step of
releasing at least one material from a delivery portion of a
delivery device mounted within a nasal region of a subject in
response to a delivery control signal corresponding to a desired
release pattern, as indicated at step 1708.
[0141] As shown in FIG. 59, the method may include the steps of
sensing at least one parameter of interest in the nasal region with
a sensor in the delivery device at 1752, storing a record of at
least one sensed value of the at least one parameter of interest at
1754, and releasing at least one material from a delivery portion
of a delivery device mounted within a nasal region of a subject in
response to a delivery control signal corresponding to a desired
release pattern at 1756, including controlling the release of the
at least one material based upon the value of the at least one
parameter of interest at 1758.
[0142] Some embodiments of the method may include generating a
delivery control signal at least in part as a function of the
individual identity of the subject.
[0143] As shown in FIG. 60, the method may include receiving the at
least one material from at least one source located remote from the
delivery portion of the delivery device at step 1802, and releasing
at least one material from a delivery portion of a delivery device
mounted within a nasal region of a subject in response to a
delivery control signal corresponding to a desired release pattern
at 1804.
[0144] A shown in FIG. 61, releasing at least one material from a
delivery portion of a delivery device mounted within a nasal region
of a subject in response to a delivery control signal corresponding
to a desired release pattern at 1852 may include releasing at least
one material including a systemically active material, as indicated
at 1854, releasing at least one material include a material having
local activity in the nasal region, nasopharynx, or pulmonary
region, as indicated at 1856 releasing at least one material
including an odorant, an aroma, an olfactory modulator or a scented
material, as indicated at 1858, or releasing at least one material
including one or more neurotransmitters or neurotransmitter
inhibitors, as indicated at 1860.
[0145] In some embodiments, as shown in FIG. 62, the method may
include calculating the delivery control signal based upon one or
more stored parameters, at 1902, and releasing at least one
material from a delivery portion of a delivery device mounted
within a nasal region of a subject in response to the delivery
control signal corresponding to a desired release pattern at
1904.
[0146] In an embodiment as shown in FIG. 63, in addition to the
steps of calculating the delivery control signal based upon one or
more stored parameters, at 1906, and releasing at least one
material from a delivery portion of a delivery device mounted
within a nasal region of a subject in response to a delivery
control signal corresponding to a desired release pattern at 1908,
the method may include storing the one or more stored parameters in
the delivery device prior to generation of the delivery control
signal, as shown at step 1904. The one or more stored parameters
may be received from an input device operatively connected to the
delivery device, at step 1902. For example, the method may include
receiving the one or more stored parameters from the input device
via an optical connection, as shown at 1910, receiving the one or
more stored parameters from the input device via a wired
connection, as shown at 1912, or receiving the one or more stored
parameters from the input device via a wireless connection, as
shown at 1914. In other embodiments, the method may instead (or in
addition) include calculating the delivery control signal based
upon one or more prior values of the delivery control signal.
[0147] As shown in FIG. 64, one embodiment of the method may
include generating the delivery control signal from a stored
release pattern, at step 1952, before releasing at least one
material from a delivery portion of a delivery device mounted
within a nasal region of a subject in response to a delivery
control signal corresponding to a desired release pattern at step
1954. As shown in FIG. 65, in addition to generating the delivery
control signal from a stored release pattern, at step 2006, and
releasing at least one material from a delivery portion of a
delivery device mounted within a nasal region of a subject in
response to a delivery control signal corresponding to a desired
release pattern at step 2008, the method may include a step of
storing the release pattern in the delivery device prior to
generation of the delivery control signal, at step 2004. The method
may also include a step of receiving the release pattern from an
input device operatively connected to the delivery device, at 2002,
for example, by receiving the release pattern from the input device
via an optical connection, as indicated at 2010, receiving the
release pattern from the input device via a wired connection, as
indicated at 2012, or receiving the release pattern from the input
device via a wireless connection, as indicated at 2014.
[0148] Methods of using devices and systems as described herein may
include not only the use of the device while it is mounted within
the nasal region of a subject, but may also include steps of
mounting at least a portion of the delivery device within the nasal
region of the subject, and optionally, removing at least a portion
of the delivery portion of the delivery device from the nasal
region of the subject following a use period. It will be
appreciated that for short use periods, a method may include
mounting at least a portion of the delivery device within the nasal
region of the subject prior to releasing the at least one material
from the delivery portion of the delivery device and removing at
least the delivery portion of the delivery device from the nasal
region of the subject following a use period. On the other hand, in
applications where the device is mounted in the nasal region of the
subject substantially permanently, the device may be mounted in the
nasal region, and no steps taken to remove the device. In some
cases, the device may be mounted manually, by the subject, or by
someone acting on behalf of the subject, for example a medical care
provider. In some cases, the emplacement of the device within the
nasal region may performed with the use of an installation device,
such as a tool that will hold the device to allow it to be inserted
into portions of the nasal region that would otherwise be
inaccessible. Local or general anesthetic may be provided in
certain cases, as appropriate to provide for the comfort of the
subject.
[0149] According to various embodiments, a controllable release
nasal system may include software for controlling the release of
material from a delivery device mounted within a nasal region of a
subject. Such software is illustrated in a block diagram in FIG.
66. The basic components of the controllable release nasal system
2050 may include software 2052, at least one sensor 2054, a
delivery portion 2056, and a user input device 2058. Non-software
components are described elsewhere herein. Software 2052 may
include a control signal generation module 2060 capable of
generating a delivery control signal corresponding to a desired
pattern of delivery of a material into a nasal region of a subject
from a delivery portion of the delivery device mounted within the
nasal region of the subject, according to a model of the entire
system. Software 2052 may include at least one of a data storage
module 2062 capable of storing pattern data or pattern parameters
representing the desired pattern of delivery of the material into
the nasal region of the subject or a sensing module 2064 capable of
receiving and processing a sense signal from a sensor portion of
the delivery device, wherein the control signal generation module
is configured to generate the delivery control signal based upon at
least one of the pattern data, pattern parameters or sense signal,
generally proceeding according to a model. In another aspect, the
software may include both a data storage module 2062 capable of
controlling storage of pattern data or pattern parameters
representing the desired pattern of delivery of the material into
the nasal region of the subject according to a model and a sensing
module 2064 capable of receiving and processing a sense signal from
a sensor portion 2054 of the delivery device.
[0150] Data storage module 2062 may be capable of storing a sense
signal received from the sensing module 2064. The sense signal may
be a processed sense signal from the sensor portion 2054 of the
delivery device. The software may include a data storage module
2062 configured to store one or more values from the delivery
device. At least a portion of the one or more values may be sense
signal values received from the sensing module 2064. Alternatively,
or in addition, at least a portion of the one or more values are
sense parameters received from the sensing module 2064. In some
embodiments, at least a portion of the one or more values may be
delivery control signal values from the control signal generation
module 2060.
[0151] In another aspect, the software may include a user interface
module 2066 configured to receive user input of one or more
user-enterable parameters from a user interface device. The
software may include a user interface module 2066 configured to
receive user input of a desired delivery pattern from a user
interface device 2058. In some embodiments, the user interface
module may be configured to receive the desired delivery pattern in
the form of a digital data transmission.
[0152] The software may include a sensing module 2064 capable of
receiving and processing a sense signal from a sensor portion 2054
of the delivery device. The sensing module 2064 may be capable of
processing the sense signal by various signal processing methods as
are known to those of skill in the art, including, but not limited
to filtering, windowing, noise reduction, signal averaging, feature
detection, time-domain analysis, frequency domain analysis, feature
extraction, comparison of the sense signal with, e.g., a template
sense signal, sorting, data reduction, or endpoint
determination.
[0153] In some embodiments, the control signal generation module
2060 may be capable of generating the delivery control signal by
calculating the delivery control signal based upon one or more
stored parameters. In some embodiments, at least a portion of the
stored parameters may be specific to the subject, relating to size,
weight, age, gender, medical or health status, and so forth. The
control signal generation module 2060 may be capable of generating
the delivery control signal from a stored release pattern. The
parameters or release pattern may be stored in a data storage
location under the control of data storage module 2062.
[0154] Delivery devices and systems as described herein may be
operated under the control of software. Certain components of
system 2050 may be primarily hardware-based, e.g., sensor portion
2054, delivery portion 2056, and, optionally, user interface device
2058. Hardware-based devices may include components that are
electrical, mechanical, chemical, optical, electromechanical,
electrochemical, electro-optical, and are not limited to the
specific examples presented herein. Control signal generation
module 2060, data storage module 2062, sensing module 2064, and use
interface module 2066 may be all or mostly software-based; however,
it will be appreciated that various operations may be performed in
hardware, software, firmware, or various combinations thereof.
[0155] Those having skill in the art will recognize that the state
of the art has progressed to the point where there is little
distinction left between hardware and software implementations of
aspects of systems; the use of hardware or software is generally
(but not always, in that in certain contexts the choice between
hardware and software can become significant) a design choice
representing cost vs. efficiency tradeoffs. Those having skill in
the art will appreciate that there are various vehicles by which
processes and/or systems and/or other technologies described herein
can be effected (e.g., hardware, software, and/or firmware), and
that the preferred vehicle will vary with the context in which the
processes and/or systems and/or other technologies are deployed.
For example, if an implementer determines that speed and accuracy
are paramount, the implementer may opt for a mainly hardware and/or
firmware vehicle; alternatively, if flexibility is paramount, the
implementer may opt for a mainly software implementation; or, yet
again alternatively, the implementer may opt for some combination
of hardware, software, and/or firmware. Hence, there are several
possible vehicles by which the processes and/or devices and/or
other technologies described herein may be effected, none of which
is inherently superior to the other in that any vehicle to be
utilized is a choice dependent upon the context in which the
vehicle will be deployed and the specific concerns (e.g., speed,
flexibility, or predictability) of the implementer, any of which
may vary. Those skilled in the art will recognize that optical
aspects of implementations will typically employ optically-oriented
hardware, software, and or firmware.
[0156] The foregoing detailed description has set forth various
embodiments of the devices and/or processes via the use of block
diagrams, flowcharts, and/or examples. Insofar as such block
diagrams, flowcharts, and/or examples contain one or more functions
and/or operations, it will be understood by those within the art
that each function and/or operation within such block diagrams,
flowcharts, or examples can be implemented, individually and/or
collectively, by a wide range of hardware, software, firmware, or
virtually any combination thereof. In one embodiment, several
portions of the subject matter described herein may be implemented
via Application Specific Integrated Circuits (ASICs), Field
Programmable Gate Arrays (FPGAs), digital signal processors (DSPs),
or other integrated formats. However, those skilled in the art will
recognize that some aspects of the embodiments disclosed herein, in
whole or in part, can be equivalently implemented in integrated
circuits, as one or more computer programs running on one or more
computers (e.g., as one or more programs running on one or more
computer systems), as one or more programs running on one or more
processors (e.g., as one or more programs running on one or more
microprocessors), as firmware, or as virtually any combination
thereof, and that designing the circuitry and/or writing the code
for the software and or firmware would be well within the skill of
one of skill in the art in light of this disclosure. In addition,
those skilled in the art will appreciate that the mechanisms of the
subject matter described herein are capable of being distributed as
a program product in a variety of forms, and that an illustrative
embodiment of the subject matter described herein applies
regardless of the particular type of signal bearing medium used to
actually carry out the distribution. Examples of a signal bearing
medium include, but are not limited to, the following: a recordable
type medium such as a floppy disk, a hard disk drive, a Compact
Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer
memory, etc.; and a transmission type medium such as a digital
and/or an analog communication medium (e.g., a fiber optic cable, a
waveguide, a wired communications link, a wireless communication
link, etc.).
[0157] In a general sense, those skilled in the art will recognize
that the various embodiments described herein can be implemented,
individually and/or collectively, by various types of
electromechanical systems having a wide range of electrical
components such as hardware, software, firmware, or virtually any
combination thereof; and a wide range of components that may impart
mechanical force or motion such as rigid bodies, spring or
torsional bodies, hydraulics, and electro-magnetically actuated
devices, or virtually any combination thereof. Consequently, as
used herein "electro-mechanical system" includes, but is not
limited to, electrical circuitry operably coupled with a transducer
(e.g., an actuator, a motor, a piezoelectric crystal, etc.),
electrical circuitry having at least one discrete electrical
circuit, electrical circuitry having at least one integrated
circuit, electrical circuitry having at least one application
specific integrated circuit, electrical circuitry forming a general
purpose computing device configured by a computer program (e.g., a
general purpose computer configured by a computer program which at
least partially carries out processes and/or devices described
herein, or a microprocessor configured by a computer program which
at least partially carries out processes and/or devices described
herein), electrical circuitry forming a memory device (e.g., forms
of random access memory), electrical circuitry forming a
communications device (e.g., a modem, communications switch, or
optical-electrical equipment), and any non-electrical analog
thereto, such as optical or other analogs. Those skilled in the art
will recognize that electro-mechanical as used herein is not
necessarily limited to a system that has both electrical and
mechanical actuation except as context may dictate otherwise.
Non-electrical analogs of electrical circuitry may include fluid
circuitry, electro-mechanical circuitry, mechanical circuitry, and
various combinations thereof.
[0158] In a general sense, those skilled in the art will recognize
that the various aspects described herein which can be implemented,
individually and/or collectively, by a wide range of hardware,
software, firmware, or any combination thereof can be viewed as
being composed of various types of "electrical circuitry."
Consequently, as used herein "electrical circuitry" includes, but
is not limited to, electrical circuitry having at least one
discrete electrical circuit, electrical circuitry having at least
one integrated circuit, electrical circuitry having at least one
application specific integrated circuit, electrical circuitry
forming a general purpose computing device configured by a computer
program (e.g., a general purpose computer configured by a computer
program which at least partially carries out processes and/or
devices described herein, or a microprocessor configured by a
computer program which at least partially carries out processes
and/or devices described herein), electrical circuitry forming a
memory device (e.g., forms of random access memory), and/or
electrical circuitry forming a communications device (e.g., a
modem, communications switch, or optical-electrical equipment).
Those having skill in the art will recognize that the subject
matter described herein may be implemented in an analog or digital
fashion or some combination thereof.
[0159] One skilled in the art will recognize that the herein
described components (e.g., steps), devices, and objects and the
discussion accompanying them are used as examples for the sake of
conceptual clarity and that various configuration modifications are
within the skill of those in the art. Consequently, as used herein,
the specific exemplars set forth and the accompanying discussion
are intended to be representative of their more general classes. In
general, use of any specific exemplar herein is also intended to be
representative of its class, and the non-inclusion of such specific
components (e.g., steps), devices, and objects herein should not be
taken as indicating that limitation is desired.
[0160] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations are not expressly set forth
herein for sake of clarity.
[0161] The herein described subject matter sometimes illustrates
different components contained within, or connected with, different
other components. It is to be understood that such depicted
architectures are merely exemplary, and that in fact many other
architectures can be implemented which achieve the same
functionality. In a conceptual sense, any arrangement of components
to achieve the same functionality is effectively "associated" such
that the desired functionality is achieved. Hence, any two
components herein combined to achieve a particular functionality
can be seen as "associated with" each other such that the desired
functionality is achieved, irrespective of architectures or
intermedial components. Likewise, any two components so associated
can also be viewed as being "operably connected", or "operably
coupled", to each other to achieve the desired functionality, and
any two components capable of being so associated can also be
viewed as being "operably couplable", to each other to achieve the
desired functionality. Specific examples of operably couplable
include but are not limited to physically mateable and/or
physically interacting components and/or wirelessly interactable
and/or wirelessly interacting components and/or logically
interacting and/or logically interactable components.
[0162] While particular aspects of the present subject matter
described herein have been shown and described, it will be apparent
to those skilled in the art that, based upon the teachings herein,
changes and modifications may be made without departing from the
subject matter described herein and its broader aspects and,
therefore, the appended claims are to encompass within their scope
all such changes and modifications as are within the true spirit
and scope of the subject matter described herein. Furthermore, it
is to be understood that the invention is defined by the appended
claims. It will be understood by those within the art that, in
general, terms used herein, and especially in the appended claims
(e.g., bodies of the appended claims) are generally intended as
"open" terms (e.g., the term "including" should be interpreted as
"including but not limited to," the term "having" should be
interpreted as "having at least," the term "includes" should be
interpreted as "includes but is not limited to," etc.). It will be
further understood by those within the art that if a specific
number of an introduced claim recitation is intended, such an
intent will be explicitly recited in the claim, and in the absence
of such recitation no such intent is present. For example, as an
aid to understanding, the following appended claims may contain
usage of the introductory phrases "at least one" and "one or more"
to introduce claim recitations. However, the use of such phrases
should not be construed to imply that the introduction of a claim
recitation by the indefinite articles "a" or "an" limits any
particular claim containing such introduced claim recitation to
inventions containing only one such recitation, even when the same
claim includes the introductory phrases "one or more" or "at least
one" and indefinite articles such as "a" or "an" (e.g., "a" and/or
"an" should typically be interpreted to mean "at least one" or "one
or more"); the same holds true for the use of definite articles
used to introduce claim recitations. In addition, even if a
specific number of an introduced claim recitation is explicitly
recited, those skilled in the art will recognize that such
recitation should typically be interpreted to mean at least the
recited number (e.g., the bare recitation of "two recitations,"
without other modifiers, typically means at least two recitations,
or two or more recitations). Furthermore, in those instances where
a convention analogous to "at least one of A, B, and C, etc." is
used, in general such a construction is intended in the sense one
having skill in the art would understand the convention (e.g., "a
system having at least one of A, B, and C" would include but not be
limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). In those instances where a convention analogous to
"at least one of A, B, or C, etc." is used, in general such a
construction is intended in the sense one having skill in the art
would understand the convention (e.g., "a system having at least
one of A, B, or C" would include but not be limited to systems that
have A alone, B alone, C alone, A and B together, A and C together,
B and C together, and/or A, B, and C together, etc.). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
"A or B" will be understood to include the possibilities of "A" or
"B" or "A and B."
[0163] While various aspects and embodiments have been disclosed
herein, other aspects and embodiments will be apparent to those
skilled in the art. The various aspects and embodiments disclosed
herein are for purposes of illustration and are not intended to be
limiting, with the true scope and spirit being indicated by the
following claims.
* * * * *
References