U.S. patent application number 13/849756 was filed with the patent office on 2013-08-15 for closure container for single dose disposable pharmaceutical delivery system.
This patent application is currently assigned to SeraTouch, LLC. The applicant listed for this patent is SeraTouch, LLC. Invention is credited to Steven Dale Kelly, James Stanley McCulloch.
Application Number | 20130211376 13/849756 |
Document ID | / |
Family ID | 38662060 |
Filed Date | 2013-08-15 |
United States Patent
Application |
20130211376 |
Kind Code |
A1 |
McCulloch; James Stanley ;
et al. |
August 15, 2013 |
CLOSURE CONTAINER FOR SINGLE DOSE DISPOSABLE PHARMACEUTICAL
DELIVERY SYSTEM
Abstract
Provided herein is a single dose disposable pharmaceutical
delivery apparatus and methods of use and manufacture thereof. One
aspect provides a single dose disposable pharmaceutical delivery
apparatus that includes a needle hub seal attached to a needle hub
and a bladder that can contain a pharmaceutical composition.
Another aspect provides for dispensing a pharmaceutical composition
from the delivery apparatus by rupturing the needle hub seal and
fluidically connecting the needle and the bladder. Another aspect
provides manufacturing the delivery apparatus according to steps
including attaching a needle hub and a needle hub seal and
combining the bladder and the needle hub, thereby forming an
apparatus described herein.
Inventors: |
McCulloch; James Stanley;
(St. Peters, MO) ; Kelly; Steven Dale; (St.
Peters, MO) |
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Applicant: |
Name |
City |
State |
Country |
Type |
SeraTouch, LLC; |
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|
US |
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|
Assignee: |
SeraTouch, LLC
St. Peters
MO
|
Family ID: |
38662060 |
Appl. No.: |
13/849756 |
Filed: |
March 25, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13007656 |
Jan 16, 2011 |
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13849756 |
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12425705 |
Apr 17, 2009 |
7892211 |
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13007656 |
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11456452 |
Jul 10, 2006 |
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12425705 |
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60746261 |
May 3, 2006 |
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Current U.S.
Class: |
604/506 ; 29/428;
53/452; 604/192; 604/197; 604/200 |
Current CPC
Class: |
A61M 5/286 20130101;
A61M 5/002 20130101; A61M 5/282 20130101; A61M 2005/312 20130101;
Y10T 29/49826 20150115; A61M 2207/00 20130101; A61M 5/3202
20130101 |
Class at
Publication: |
604/506 ;
604/200; 604/192; 604/197; 29/428; 53/452 |
International
Class: |
A61M 5/28 20060101
A61M005/28; A61M 5/00 20060101 A61M005/00; A61M 5/32 20060101
A61M005/32 |
Claims
1. A single dose disposable pharmaceutical delivery apparatus
comprising: a bladder to contain a pharmaceutical composition; a
needle; a needle hub; and a needle hub seal; wherein: the needle is
secured to the needle hub; the needle is in a stationary position
relative to the bladder; the needle hub seal is attached to the
needle hub; and dispensing the pharmaceutical composition comprises
rupturing the needle hub seal and fluidly connecting the needle and
the bladder.
2. The apparatus of claim 1, wherein the apparatus does not contain
a bladder seal connected to the bladder and the needle is fluidly
connected with the bladder when the needle hub seal is
ruptured.
3. The apparatus of claim 1, comprising a bladder seal, wherein the
bladder seal is positioned between the bladder and the needle; and
the needle is fluidly connected with the bladder upon rupture of
the bladder seal and the needle hub seal.
4. The apparatus of claim 1, comprising a needle cap, wherein the
needle cap fluidly seals the needle and removal of the needle cap
fluidly unseals the needle.
5. The apparatus of claim 1 wherein the needle is fixedly attached
to and extending from the needle hub.
6. The apparatus of claim 1 wherein the needle is rigidly attached
to and extending from the needle hub.
7. The apparatus of claim 1, wherein the needle is about 22 gauge
to about 29 gauge.
8. The apparatus of claim 1, wherein the needle comprises an
exposed portion distal to the needle hub and the exposed portion of
the needle is about 0.25 inches to about 1.0 inch in length.
9. The apparatus of claim 8, wherein the needle is suitable for
intradermal or subcutaneous injections.
10. The apparatus of claim 1, wherein the bladder comprises a
volume of about 0.5 cc to about 3.0 cc.
11. The apparatus of claim 1, wherein the bladder comprises a
polyethylene or a polypropylene material.
12. The apparatus of claim 1, comprising an envelope, the envelope
comprising an anterior sheet and a posterior sheet; wherein, the
envelope encompasses the bladder.
13. The apparatus of claim 12, wherein the anterior sheet and the
posterior sheet form the bladder.
14. The apparatus of claim 12, wherein the bladder is formed
separately from the anterior sheet or the posterior sheet.
15. The apparatus of claim 12, wherein, the envelope comprises a
first envelope portion and a second envelope portion; the first
envelope portion comprising the bladder; the second envelope
portion comprising a needle cap; and the needle cap fluidly seals
the needle and removal of the needle cap fluidly unseals the
needle.
16. The apparatus of claim 12, wherein separating the first
envelope portion and the second envelope portion removes the needle
cap and fluidly unseals the needle.
17. The apparatus of claim 1, comprising a fill port, wherein the
fill port facilitates filling of the bladder with the
pharmaceutical.
18. A method of manufacturing the apparatus of claim 1, comprising:
attaching a needle hub and a needle hub seal; and combining a
bladder and the needle hub; thereby forming an apparatus according
to claim 1.
19. The method of claim 18, comprising one or more of the
following: forming the bladder from an anterior sheet and a
posterior sheet; filling the bladder with a pharmaceutical
composition; securing the needle to the needle hub; encompassing
the bladder with an envelope; attaching a bladder seal to the
bladder; and attaching a needle cap to the needle.
20. A method of using the apparatus of claim 1 to deliver a
pharmaceutical composition comprising: applying pressure to the
bladder; rupturing the needle hub seal; and dispensing the
pharmaceutical composition from the bladder and through the needle.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuing Application of U.S.
application Ser. No. 13/007,656, filed Jan. 16, 2011, which in turn
is a Continuing Application of U.S. application Ser. No.
12/425,705, filed Apr. 17, 2009, issued as U.S. Pat No. 7,892,211
on Feb. 22, 2011, which in turn is a Continuing Application of U.S.
application Ser. No. 11/456,452, filed Jul. 10, 2006, which claims
priority to U.S. Provisional Application Ser. No. 60/746,261, filed
on May 3, 2006, each of which is incorporated herein by reference
in their entirety.
BACKGROUND
[0002] This invention relates to closure containers for single dose
disposable pharmaceutical delivery systems. The system has
particular advantage for battlefield applications, mass
immunizations in underdeveloped areas of the world and other
general medical applications currently being serviced by pre-filled
syringes.
[0003] During World War II Squibb, now Bristol-Myers Squibb,
developed the disposable morphine Syrette.RTM.. It consisted of a
small tube of morphine with an attached hypodermic needle. Medical
personnel first had to break a seal with a small needle. The
morphine was administered by piercing the patient's skin with the
needle and then squeezing the tube.
[0004] A number of prior art patents for a disposable single dose
dispenser utilize a moveable needle to puncture the container
holding the pharmaceutical including: U.S. Pat. Nos. 2,676,591;
2,687,727; 2,693,183; 3,192,925 and 4,883,473. The present
invention does not utilize a moveable needle to puncture the
container holding the pharmaceutical.
[0005] U.S. Pat. No. 2,618,263 for a "Disposable Single-Use
Syringe" is a disposable, single use, prefilled unit dose
pharmaceutical delivery system; however, the structural design is
different from the present invention. In the '263 Patent, the
ampoule is easily moved by a finger so that the needle punctures
the ampoule, whereupon with further pressure being exerted on the
ampoule, the contents thereof is expressed through the needle for
the intended function of the syringe. The needle in the present
invention is straight and the needle in the '263 Patent is not.
[0006] U.S. Pat. No. 3,736,933 is a "Burstable Seamed Hypodermic
Applicator." This prior art patent does not show a single
dispensing apparatus with a single cap. Rather, the '933 Patent
discloses a plurality of dispensing applicators in a single
elongate shield to receive and cap multiple needles. In other
words, this patent discloses a package with several dispensing
applicators that can be selectively withdrawn from the single
elongate shield/cap. The present invention uses a single shield/cap
for each dispensing apparatus.
[0007] U.S. Pat. No. 4,548,601 is a "Prepackaged, Injectable
Pharmaceutical and Hypodermic Needle Combination." The combination
is a disposable, single use, prefilled unit dose pharmaceutical
delivery system; however, the structural design is different from
the present invention. In the '601 Patent, "the injectable
medication is contained within a substantially non-resilient,
highly flexible sack or inner container which is indirectly
compressed, pneumatically, by means of a resilient, comparatively
rigid outer container. Manual collapsing pressure or squeezing of
the outer container serves, in successive operations, to completely
discharge the contents of the inner container through a cannulae,
thereby injecting its full dose." The present invention does not
use the pneumatic pump of this prior art patent; instead, the
present invention relies on manual pressure of the thumb and
forefinger to discharge the pharmaceutical from the bladder. This
prior art patent discloses a rupture seal, but no fill port.
[0008] U.S. Pat. No. 4,955,871 is a "Single-Use Disposable Syringe"
that is prefilled unit dose pharmaceutical delivery system;
however, the structural design is different from the present
invention. The '871 Patent is designed to allow aspiration for
intramuscular and intravenous injections whereas the present
invention is not designed for aspiration. The '871 Patent is
designed to create negative pressure in a reservoir means 46 formed
from a pair of sheets 38a and 38b. The bladder of the present
invention is not designed to create negative pressure. The present
invention uses a needle seal that is ruptured by pressure. The '871
Patent uses the sharp end of the needle to penetrate the nozzle
membrane 22. The '871 Patent discloses a fill port 58 for the
reservoir 46, but no rupture seal.
[0009] U.S. Pat. No. 5,019,048 is a "Unit Dose Syringe with
Rotatable Needle." This prior art patent discloses a disposable,
single use, prefilled unit dose pharmaceutical delivery system;
however, the structural design is different from the present
invention. FIGS. 7 and 8 show an embodiment wherein a needle 55 is
connected to a plastic squeeze bag 56 by an unstructured flexible
plastic fitting at 57 in the manner of a bagpipe where the needle
is analogous to the pipe of the bagpipe. FIG. 7 shows the needle 55
in the protected position inside a pocket 59. Pocket 59 includes a
tear strip, not shown, which is removed to allow needle 55 to
assume the position shown in FIG. 8. In use, a chuck 60 grips the
needle as shown in FIG. 9. Once the needle is secured in the chuck,
the contents of the bag are easily administered. Unlike this prior
art patent, the present invention does not have a separate chuck
for administration of the pharmaceutical, nor does the present
invention have a rotating needle.
[0010] U.S. Pat. No. 5,810,783 is a "Medication Injector" which is
a disposable, single use, prefilled unit dose pharmaceutical
delivery system; however, the structural design is different from
the present invention. To avoid fluid escape during storage, from
this prior art patent, the needle 4 is enclosed in a flexible
plastic tube 5, closed at its distal end 6 by heat-sealing, to keep
air inside the needle 4, acting as a blockage to the fluid. The
tube 5 is further enclosed in an air tight envelope 7 as best seen
in FIGS. 1A and 2 of this prior art patent. The present invention
uses a single cap to shield the needle, unlike this two part
shielding system in the '783 Patent.
[0011] Owen Mumford Ltd. of Oxon in the United Kingdom advertises a
"Snapdragon" single use disposable auto injector. The device is
promoted as a single-use, disposable, safety injection device for
use with a pre-filled glass syringe. The present invention does not
use a pre-filled glass syringe.
[0012] Many attempts have been made to produce a single dose
disposable pharmaceutical delivery system to replace conventional
prefilled syringes; unfortunately none of these attempts have been
economically competitive. There remains a need for a reliable unit
dose disposable pharmaceutical delivery system that is economical
to produce.
SUMMARY OF THE INVENTION
[0013] The unit dose disposable pharmaceutical delivery system is
formed as a generally flat envelope about the size of a credit card
having a tear-away portion and a dispensing portion. The
pharmaceutical is stored in a bladder and is dispensed through a
needle that is stationary in relationship to the bladder. In other
words, the needle is not moved to puncture the bladder, prior to
dispensing of the pharmaceutical. This delivery system is used to
make intradermal or subcutaneous injections and thus the exposed
portion of the needle can be relatively short. This system has
particular advantage for battlefield applications, mass
immunizations in underdeveloped areas of the world, and other
general medical applications currently being serviced by pre-filled
syringes. The delivery system may also be helpful to numerous
individuals that do not have formal medical training, such as for
insulin injections and/or emergency epinephrine injections.
[0014] Other objects and features will be in part apparent and in
part pointed out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Those of skill in the art will understand that the drawings,
described below, are for illustrative purposes only. The drawings
are not intended to limit the scope of the present teachings in any
way.
[0016] FIG. 1 is a top plan view of the unit dose disposable
pharmaceutical delivery system with the tear-away portion of the
envelope joined to the delivery portion;
[0017] FIG. 2 is a section view of the unit dose disposable
pharmaceutical delivery system of FIG. 1 along the line 2-2;
[0018] FIG. 3 is a top plan view of the unit dose disposable
pharmaceutical delivery system with the tear away portion removed
from the delivery portion of the envelope;
[0019] FIG. 4 is a section view of the unit dose disposable
pharmaceutical delivery system of FIG. 3 along the line 4-4;
[0020] FIG. 5 is a top plan view of the exploded components of the
unit dose disposable pharmaceutical delivery system; and
[0021] FIG. 6 is a section view of the exploded components of the
unit dose disposable pharmaceutical delivery system of FIG. 6 along
the line 7-7.
DETAILED DESCRIPTION OF THE INVENTION
[0022] This is a description of FIGS. 1-6 of the unit dose
disposable pharmaceutical delivery system generally identified by
the numeral 10. The delivery system 10 forms an envelope 12 which
includes the tear-away portion 14 and the dispensing portion 16. A
tear line 18 divides the tear-away portion 14 from the dispensing
portion 16. To separate the two portions, the user merely tears and
slightly rotates the tear-away portion from the dispensing
portion.
[0023] The envelope 12 may be formed from an anterior sheet 20 and
a posterior sheet 22. Depending on the application, other sheets
may also be used, such as second anterior sheet 21 and second
posterior sheet 23. Other sheets, not shown may also be necessary.
The bladder 24 may be formed separately from the sheets 20 and 22
or it may be defined by the sheets 20 and 22. FIGS. 1-6 show the
bladder 24 formed separately from sheets 20, 21, 22 and 23.
[0024] In the preferred embodiment, the bladder may be formed from
a relatively stiff anterior wall 26, and posterior wall 28 joined
by a relatively flexible side wall 30. The bladder may be formed in
different shapes depending on a variety of factors including the
amount of the unit dose, the type of pharmaceutical and the
intended application. The bladder may be formed from any suitable
material, but polyethylene or polypropylene is preferred. The
bladder 24 defines a chamber 25 to hold the pharmaceutical 27.
[0025] A rigid needle hub 32 is secured to the dispensing portion
16 of the envelope 12. A hollow needle 34 extends from the needle
hub and is in a fixed position relative to the bladder. Unlike many
prior art patents, the needle of the present invention does not
move to puncture the bladder, prior to injection of the
pharmaceutical. The needle may have a sharp point 36, a crown point
38, such as used by allergists or some other design. Any gauge
needle may be used, but from about 22 gauge to about 29 gauge is
preferred. A needle cap 40 is secured to the tear-away portion of
the envelope and has a cavity 42 sized and arranged to receive the
exposed portion of the needle 44. The exposed portion of the needle
may be of any length including from about 0.25 inches to about 1.0
inches. When injecting the pharmaceutical, the bladder 24 is in
fluid communication with the needle 34. However, prior to the
injection, the bladder may or may not be in fluid communication
with the needle as discussed below.
[0026] The delivery system may be used for any size unit dose, but
preferably from about 0.5 cc to about 3.0 cc. The delivery system
10 may use the needle cap to seal the pharmaceutical in the bladder
or the delivery system may have one or more seals used in addition
to or in lieu of the needle cap. For example, a bladder seal 46 may
be positioned between the bladder and the needle as better seen in
FIGS. 5 and 6. When pressure is applied to the bladder by the thumb
and forefinger, the pressurized pharmaceutical ruptures the bladder
seal 46 and flows into the needle 34. The delivery system 10 may
use the needle cap to seal the pharmaceutical in the bladder, as
previously mentioned or the delivery system may use the bladder
seal 46 and/or a needle hub seal 48, as better seen in FIGS. 5 and
6. Again, the pressurized pharmaceutical ruptures the needle hub
seal 48 and/or the bladder seal 46 allowing the pharmaceutical to
flow into the needle 34. Other rupture seals, not show, may also be
used in this delivery system in conjunction with or in lieu of the
bladder seal 46, the needle hub seal 48 and/or the needle cap
40.
[0027] A fill port 50 may be positioned in the bladder to
facilitate filling of the bladder with the pharmaceutical. The fill
port may be formed from a soft elastomeric compound which is easily
pierced by a fill needle during the manufacturing process. In the
alternative, the bladder may be filled in other ways without the
need for a fill port.
[0028] The exterior surface 51 of the envelope may be printed with
various types of indicia, including but not limited to,
pharmaceutical indicia 54 to identify the name of the
pharmaceutical in the delivery system, unit dose indicia 56 to
indicate the amount of the pharmaceutical in the delivery system,
needle gauge indicia 58 and needle length indicia 59. For
advertising purposes, supplier indicia 60 to indicate the maker of
the pharmaceutical, such as Pfizer, or the producer of the delivery
system, such as Becton and Dickinson, commonly abbreviated to BD in
the industry.
[0029] Having described the invention in detail, it will be
apparent that modifications, variations, and equivalent embodiments
are possible without departing the scope of the invention defined
in the appended claims. Furthermore, it should be appreciated that
all examples in the present disclosure are provided as non-limiting
examples.
* * * * *