U.S. patent application number 14/637066 was filed with the patent office on 2016-07-14 for nasal delivery device and methods of use.
This patent application is currently assigned to BHL PATENT HOLDINGS LLC. The applicant listed for this patent is BHL PATENT HOLDINGS LLC. Invention is credited to Judah Isaacs, Bruce Levin.
Application Number | 20160199599 14/637066 |
Document ID | / |
Family ID | 56366779 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199599 |
Kind Code |
A1 |
Isaacs; Judah ; et
al. |
July 14, 2016 |
Nasal Delivery Device and Methods of Use
Abstract
The present invention provides a drug delivery system that
includes a housing configured to contain one or more dispensers.
Each dispenser includes an activation mechanism, a nozzle
configured to direct the medicament to a predetermined area in the
nasal passageway. The nozzles may be configured to create a spray
pattern that is about 50-degrees to direct the delivery of a
medicament to the sphenopalatine ganglion.
Inventors: |
Isaacs; Judah; (Oceanside,
NY) ; Levin; Bruce; (Oceanside, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BHL PATENT HOLDINGS LLC |
Towanda |
PA |
US |
|
|
Assignee: |
BHL PATENT HOLDINGS LLC
Towanda
PA
|
Family ID: |
56366779 |
Appl. No.: |
14/637066 |
Filed: |
March 3, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62102958 |
Jan 13, 2015 |
|
|
|
Current U.S.
Class: |
128/200.14 |
Current CPC
Class: |
A61M 11/007 20140204;
A61M 15/0041 20140204; A61M 2206/16 20130101; A61M 15/0003
20140204; A61M 15/08 20130101 |
International
Class: |
A61M 15/08 20060101
A61M015/08; A61M 11/00 20060101 A61M011/00 |
Claims
1. A drug delivery system comprising: a housing configured to
contain one or more unit dispensers; a user activation mechanism,
effective when activated, to engage a drug delivery mechanism to
expel medicament from a dispenser; and a nozzle configured to
direct the medicament to a predetermined area in the nasal
passageway.
2. The drug delivery system of claim 1 wherein said housing is
comprised of two mirror image dispensers.
3. The drug delivery system of claim 2 wherein each of said
dispensers includes an activation mechanism located medially to the
user.
4. The drug delivery system of claim 2 wherein each of said
dispensers includes a nozzle configured to direct a medicament to
the sphenopalatine ganglion.
5. The drug delivery system of claim 4 wherein each of said
dispensers includes a curved nozzle configured to direct a
medicament to the sphenopalatine ganglion.
6. The drug delivery system of claim 4 wherein each of said nozzles
extend from an edge that forms a line that may be positioned along
a user's upper lip, said edge acts as a guide.
7. The drug delivery system of claim 6 wherein each of said
dispensers include a shoulder, said shoulder and said edge act as a
stop that prevents further insertion of the nozzle.
8. The drug delivery system of claim 7 wherein each of said nozzles
are configured to create a spray pattern that is about 50-degrees
to direct the delivery of a medicament to the sphenopalatine
ganglion.
9. The drug delivery system of claim 8 wherein each of said nozzles
are further configured to form an arch of about 61-degrees.
10. The drug delivery system of claim 9 wherein each of said
nozzles are rotated 19-degrees to provide approximately 90-degrees
of total rotation from a vertical position to direct the delivery
of a medicament to the sphenopalatine ganglion.
11. The drug delivery system of claim 1 wherein each of said
nozzles are conical in shape so that upon insertion into the nasal
cavity, a seal is formed such no medicament escapes.
12. The drug delivery system of claim 11 wherein said activation
mechanism is positioned such that when a user grasps the dispenser,
the user's thumb may be used to actuate the activation
mechanism.
13. The drug delivery system of claim 12 wherein said activation
mechanism is directed toward the user.
14. A method for delivering a medication to the sphenopalatine
ganglion, which comprises: providing a housing having releasably
connected first and second dispensers, each of said dispensers
including a nozzle disposed between a pair of shoulders and said
nozzle configured to form an arch of about 61-degrees;
disconnecting said dispensers from another and using each
respective dispenser to deliver a unit dosage by inserting a nozzle
until said shoulders prevent further insertion; rotating said
dispenser approximately 19 degrees to direct the medication to the
sphenopalatine ganglion.
15. The method of claim 14 wherein each of said nozzles are
configured to create a spray pattern that is about 50-degrees to
direct the delivery of a medicament to the sphenopalatine
ganglion.
16. The method of claim 14 wherein each of said nozzles are conical
in shape so that upon insertion, a seal is formed such that when
the device is activated spray is contained in the nasal cavity.
17. The method of claim 14 wherein said dispensers include an
activation mechanism that is positioned such that when a user
grasps a dispenser, the user's thumb may be used to actuate the
device.
18. The method of claim 14 wherein said nozzles generate a vortex
of fluid.
19. The drug delivery system of claim 1 wherein each of said
nozzles creates a vortex.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit U.S. Provisional
Application No. 62/102,958, filed Jan. 13, 2015 and herein
incorporated by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH &
DEVELOPMENT
Not applicable.
[0002] INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC
[0003] Not applicable.
BACKGROUND OF THE INVENTION
[0004] The present invention relates to a nasal delivery device for
the intranasal delivery of a medicament. Delivery of a medicament
through the nasal passageway is often the optimal mode of delivery
for certain medicaments. To accomplish this, using rudimentary
devices and methods, a syringe or cotton swab is used.
[0005] In syringe or plunger-type devices, a user exerts pressure
on a plunger to urge the liquid out of the sprayer. However, to
properly administer the medicament through a nasal passageway, the
spray nozzle must generate a spray. A therapeutically effective
spray is not achieved unless the plunger is actuated at a certain
speed that is sufficient to create a spray. A failure to generate
sufficient speed results in the liquid being ejected in a stream or
drops instead of a spray. Too much speed may result in overdosing.
Thus, traditional methods of nasal delivery, while affording a
measure of simplicity for the user, have a number of problems,
including waste and cost arising from errors in drug
administration; and over or under dosing arising from inexact
administration of the drug. Moreover, the easier a therapeutic drug
is to administer, the more interested a patient will be in the
drug. This may then result in an increase in compliance with taking
the drug and a resulting increase in use.
BRIEF SUMMARY OF THE INVENTION
[0006] In one embodiment, the present invention relates to a
medical device for intranasal delivery of a medicament. The
medicament may be any type of medicament suitable for nasal
administration and delivery in the form of a spray.
[0007] In other embodiments, the present invention ensures that a
complete dosage of the medicament is delivered, especially to
specific areas in the nasal cavity such as the rear of the nasal
cavity where the sphenopalatine ganglion (hereinafter, the "SPG")
is located.
[0008] According to an embodiment of the invention, the nasal spray
device includes a body having a container for holding a medicament
to be administered, and an actuator that is actuatable to cause the
delivery of the medicament out of the container. More specifically,
the present invention relates to a delivery device for delivery of
a medicament to a user including a container defining a reservoir
for storing the medicament, a body in which the container is
received, a spray nozzle arranged on one end of the body and the
container for receiving medicament expelled from the container, and
an actuator.
[0009] In further embodiments, the present invention includes a
nozzle configured to target a specific location in the nasal
cavity. A preferred targeted location is the SPG, which is
relatively inaccessible as a result of being located below a region
of epithelium in the posterior portion of the nasal cavity,
inferior to and including the spheno-ethmoidal recess.
[0010] In yet other embodiments, the present invention is directed
to delivery systems that administer single doses of one or more
substances, for example a liquid, powder, or gel, to each nostril
of a user. As used herein, the term "delivery system" is
interchangeable with "delivery device" or "device." The delivery
systems of the present invention may deploy a pressurized container
to hold and deliver a predetermined volume of substance to a
particular destination with the administration, independent of the
coordination of the user.
[0011] In certain embodiments, the delivery systems disclosed
herein offer one or more of the following advantages: cost savings
(reduces waste from reducing errors in administration); improved
efficacy from the administration of consistent, premeasured
dosages; convenience and ease of use; improved patient compliance;
improved safety; improved performance due to the use of a nozzle
configured to direct the delivery of the medicament to a target
location such as the SPG.
[0012] In still further embodiments, the disclosed drug delivery
systems include a housing; a button on a surface of the housing
that actuates a firing mechanism comprising a piston or plunger in
contact with the button through a link; actuation of the button
releases the piston which drives the medicament through the nozzle
in the form of a single dosage or unit spray.
[0013] In other embodiments, the disclosed drug delivery system
includes tandem dispensers for the delivery of a unit dose of
medicament to each nostril. The dosage forms can also be included
in a cartridge that is replaceable in a drug delivery system. The
housing is configured in such embodiments to accept a cartridge
containing one or more dosage forms, which may be contained in
blister form.
[0014] Other embodiments include delivery systems that may include
a button, paddle, lever or rocker that is flush with the surface of
the delivery system in a storage mode and can be raised or tilted
up on one end thereof into the ready position to indicate that the
device is ready for use.
[0015] in additional embodiments, the dispensing mechanism uses the
button, paddle, rocker or charging lever to store energy in a
spring. When the charging button, paddle, rocker or charging lever
is pressed, the travel compresses a spring that is locked by the
dispensing release. This spring is then released or triggered by a
dispensing release button to fire the piston or ram to dispense the
fluid.
[0016] Other embodiments use pressurized dispensing. This may be
predetermined to promote accurate unit dosing.
[0017] In some embodiments, the present invention provides
intranasal delivery systems that are able to dispense single or
controlled, premeasured doses of one or more substances. In other
embodiments, the system is configured to dispense single or
controlled, premeasured doses of one or more substances to each
nostril.
[0018] Other embodiments of the delivery systems of the present
invention incorporate ergonomic designs that promote ease of
operation and that reduce the time needed for administering the
predetermined substances. Other designs include using predetermined
nozzle lengths configured to conform to differing anatomical
configurations.
[0019] As used herein, the term "substance" includes but is not
limited to one or more active-ingredient-containing substances
wherein the active ingredient may be biologic agents such as a
protein, peptide, vaccine, or an active pharmaceutical ingredient
("API"), for example a pharmaceutical drug such as a prescription
drug, generic drug, or over-the-counter pharmaceutical,
neutraceutical or homeopathic product. The substance may be in an
aqueous, gel, powder, solution, emulsion, crystals or suspension
form. As used herein, the term "substance" is interchangeable with
the terms "drug," "drug product," "medication," "liquid,"
"biologic," "active ingredient" or "API." As used herein, an
"active ingredient" or API is any component intended to furnish
pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease, or to affect
the structure or any function of the body of humans or other
animals. As used herein, the term "unit dosage form" is
interchangeable with the terms "bottle," "vial," "unit-dose,"
"dosage form," "unit-dose vial," "blister," "dosage blister,"
"ampule" or "container."
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0020] In the drawings, which are not necessarily drawn to scale,
like numerals may describe substantially similar components
throughout the several views. Like numerals having different letter
suffixes may represent different instances of substantially similar
components. The drawings illustrate generally, by way of example,
but not by way of limitation, a detailed description of certain
embodiments discussed in the present document.
[0021] FIG. 1 is an exploded, perspective view of an embodiment of
the present invention.
[0022] FIG. 2 is a right side view of an embodiment of the present
invention.
[0023] FIG. 3 is a front view of an embodiment of the present
invention.
[0024] FIG. 4 is a left side view of an embodiment of the present
invention.
[0025] FIG. 5 is another perspective view of an embodiment of the
present invention.
[0026] FIG. 6 is yet another perspective view of an embodiment of
the present invention.
[0027] FIG. 7 illustrates the operation of an embodiment of the
present invention.
[0028] FIG. 8 illustrates another preferred embodiment of the
present invention and the associated mode of operation.
[0029] FIG. 9 is perspective view of an alternate embodiment of the
present invention.
[0030] FIG. 10 is perspective view of another embodiment of the
present invention.
[0031] FIG. 11 shows an alternate embodiment of a nozzle that may
be used in the present invention.
[0032] FIG. 12 shows yet another embodiment of a nozzle that may be
used in the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0033] Detailed embodiments of the present invention are disclosed
herein; however, it is to be understood that the disclosed
embodiments are merely exemplary of the invention, which may be
embodied in various forms. Therefore, specific structural and
functional details disclosed herein are not to be interpreted as
limiting, but merely as a representative basis for teaching one
skilled in the art to variously employ the present invention in
virtually any appropriately detailed method, structure or system.
Further, the terms and phrases used herein are not intended to be
limiting, but rather to provide an understandable description of
the invention.
[0034] As shown in FIGS. 1-6, intranasal delivery device 100 may
include tandem dispensers 110 and 112 which are configured to
contain unit dosage forms as disclosed herein which may be in the
form of single unit dose as well as sterile containers used to hold
and dispense a wide range of substances. In specific preferred
embodiments, the delivery systems of the present invention may also
be designed to administer intranasal drugs, including but are not
limited to drug products, chemical drugs, or biologics for
migraines, pain management, hormones, sleep dysfunction, erectile
dysfunction, central nervous system disorders, seizures, emesis or
allergies.
[0035] Each tandem dispenser 110 and 112 includes a planar surface
120 and 122 configured to mate together as shown in FIG. 3. In
addition, the dispensers are complimentary mirror images that join
together to form the appearance of a single. In addition, the
dispensers may be configured to be releasably joined together to
promote ease of handling prior to use.
[0036] To deliver the medicament to an intended area, each
dispenser includes a nozzle 200 and 202. As shown in FIG. 7, in a
preferred embodiment, each nozzle include curved portions 210-212
that are configured to deliver a spray 260 through port 206 to a
designated area 262 which may be an area that enables a medicament
to reach the SPG.
[0037] In addition, the overall length and dimensions of the nozzle
may be arranged in differing sets of configurations. Rather than a
one size fits all design, the differing configurations may be
provided so as to provide a configuration that has been customized
for a particular anatomical configuration. In this way, the
effectiveness of the device is enhanced.
[0038] Certain embodiments of personal delivery systems described
herein include actuators 300 and 301 may be buttons, lever or other
firing mechanisms on the top surface of the delivery system to
actuate the dispensing of the substance. In one embodiment, the
button is raised above the surface to indicate that it is ready for
use, In other embodiment, the button may lie flat against the top
of the delivery system in a storage position and one end of the
button may be tilted upward, away from the device surface in the
ready position. In the ready position, depressing the button causes
a piston in communication with a spring (not shown) to compress the
dosage form and dispense the substance contained therein.
[0039] In another embodiment, the present invention provides a
delivery system described herein that includes a compressed air or
fluid reservoir, which is used to drive a plunger into the dosage
form. This embodiment can include a regulator to ensure consistent
operation as the reservoir pressure is reduced. A compressed air or
fluid reservoir allows for a lower activation force for the
operator.
[0040] Other embodiments of the delivery system described herein
may include the medicament in a dosage form that is a compressed
aerosol that is released when actuated.
[0041] Certain embodiments of the delivery system described herein
include a compressed spring, which is used to drive a plunger into
the dosage form. In this embodiment the spring, which is compressed
prior to use, provides a more consistent delivery since operator
input is limited triggering the release of stored energy rather
than providing the force to drive the plunger into the dosage
form.
[0042] In yet other aspects, the present invention provides a
dispensing unit including a dosage form that includes one or more
internal chambers, which contains a substance to be administered,
which is in fluid communication with, or is adjacent to, a
pierceable section of wall of the unit dosage form. This wall may
be an interior or exterior wall. In certain embodiments, a piercer
may move toward and pierce the pierceable section of the chamber to
allow dispersion of the substance, or the pierceable section may
move toward and be pierced by the piercer.
[0043] In use, tandem dispensers 110 and 112 typically contain a
unit dose of a medicament to be used in each of the nares. The
length of nozzle 200 is dimensioned to locate port 206 to direct
predetermined spray pattern 260 to a specific region in the nasal
passage. For the embodiment shown in FIG. 7, the targeted area is
the SPG 262 and medicament is an anesthetic for the treatment of a
migraine. By coordinating the dimensions of the nozzle with a
predetermined spray pattern of expelled. medicament, a targeted and
concentrated treatment may be delivered.
[0044] To assist a user in the placement of a dispenser, nozzle 200
and edge 270 form a line that may be positioned along a user's
upper lip 272. This acts as a guide. Edge 280 and curved portion
212 create shoulders that prevent further insertion of the device.
This, too, may be dimension to coordinate the accurate placement of
the device. In one application, the device is inserted until
shoulders 212 and 280 engage a user and indicate the device is in
an optimal placement.
[0045] FIG. 8 illustrates another preferred embodiment of the
present invention that is adapted to provide optimal targeting of
SPG 262 by spray pattern 260. As shown, has been determined that
configuring nozzle 206 to create a spray pattern 260 that is about
50-degrees provides optimal delivery of a medicament to SPG
262.
[0046] It has also been found that to improve delivery, curved
portion 210 may be configured to form an arch of about 61-degrees.
When this arch is combined with an approximate 19-degree rotation
as shown by line 280 by a user to clear upper lip 272, the device
provides approximately 90-degrees of total rotation from its
original vertical position as shown by line 281 to directly target
SPG 262. Configuring the device in this manner centers spray 260 on
line 290 to concentrate the medicament on the desired area such as
SPG 262.
[0047] FIG. 9 shows yet another embodiment of the present invention
providing a container 300 that may be configured to provide a
single dosage of medicament. The device includes a nozzle 302
having a curved portion 310, which is adapted to deliver a spray
through port 306 to a designated area such as SPG 262. In addition,
nozzle 302 may be conical or tapered in shape so that upon
insertion into the nasal cavity, a seal is formed such that when
the device is activated, no spray escapes through the nasal cavity.
Actuator 320 is positioned such that when a user grasps the device,
the user's thumb may be used to actuate the device. To do this,
actuator 320 is located perpendicular to the user's nasal
passageway.
[0048] FIG. 10 shows yet another embodiment of the present
invention providing a container 400 that may be configured to
provide a single dosage of medicament, The device includes a nozzle
402 having a curved portion 410, which is adapted to deliver a
spray through port 406 to a designated area such as SPG 262. In
addition, nozzle 402 may be conical or tapered in shape so that
upon insertion into the nasal cavity, a seal is formed such that
when the device is activated, no spray escapes through the nasal
cavity. Actuator 420 is positioned such that when a user grasps the
device, the user's thumb may be used to actuate the device. To do
this, actuator 420 is located perpendicular to the user's nasal
passageway with button 421 positioned to point at the user.
[0049] In other embodiments, as shown in FIG. 10, the device may be
used as an intranasal cleaner in addition to delivering a
medicament. The other described dispensers may be used in a similar
manner. To reach other desired areas in the nasal cavity, other
openings 407-410 may be used. Either a single opening may be
provided to direct the delivery of a fluid or medicament to another
predetermined area of the nasal cavity, or multiple openings may be
used. In other embodiments, the sizes and the configurations of the
openings may be varied as desired. Lastly, the nozzle
configurations described may also be used with the other disclosed
embodiments.
[0050] In other embodiments, the nozzles of the various disclosed
embodiments may be configured to create a vortex of fluid, powder,
or combination thereof. Creating a vortex permits a fluid, air or
spray to entraining medicaments or other desired substances. The
vortex also creates a precise flow that may be targeted with more
precision to a desired location. As shown in FIG. 11, one possible
way to create a vortex is to include fins 500-505 inside a nozzle.
As shown in FIG. 12, nozzle 600 of an alternate embodiment may
include a mixing chamber 601 feed by inlets 602 and 603 to a create
vortex that has circular, rotating pattern 604 that may be directed
to an area or anatomical location of interest.
[0051] While the foregoing written description enables one of
ordinary skill to make and use what is considered presently to be
the best mode thereof, those of ordinary skill will understand and
appreciate the existence of variations, combinations, and
equivalents of the specific embodiment, method, and examples
herein. The disclosure should therefore not be limited by the above
described embodiments, methods, and examples, but by all
embodiments and methods within the scope and spirit of the
disclosure.
* * * * *