U.S. patent application number 11/185736 was filed with the patent office on 2007-08-16 for needleless injector and ampule system.
Invention is credited to Kerry Quinn.
Application Number | 20070191762 11/185736 |
Document ID | / |
Family ID | 29998939 |
Filed Date | 2007-08-16 |
United States Patent
Application |
20070191762 |
Kind Code |
A1 |
Quinn; Kerry |
August 16, 2007 |
Needleless injector and ampule system
Abstract
A needle-less injector system having an ampule with an elongated
hollow body. The elongated hollow body includes a nozzle and an
aperture for receiving a plunger. The aperture extends from the
second end of the body towards the first end and is in fluid
communication with the nozzle. The ampule cooperates with a plunger
that has a concave rib that extends about the perimeter of the
plunger and towards the first end of the plunger. As the plunger
moves through the aperture the concave rib sealingly engages the
sidewalls of the aperture.
Inventors: |
Quinn; Kerry; (Erie,
CO) |
Correspondence
Address: |
NIXON PEABODY, LLP
401 9TH STREET, NW
SUITE 900
WASHINGTON
DC
20004-2128
US
|
Family ID: |
29998939 |
Appl. No.: |
11/185736 |
Filed: |
July 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10159853 |
May 30, 2002 |
6942638 |
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11185736 |
Jul 21, 2005 |
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Current U.S.
Class: |
604/68 |
Current CPC
Class: |
A61M 5/31513 20130101;
A61M 5/30 20130101; A61M 2005/31521 20130101; A61M 5/31515
20130101; A61M 5/3007 20130101; A61M 5/2033 20130101 |
Class at
Publication: |
604/068 |
International
Class: |
A61M 5/30 20060101
A61M005/30 |
Claims
1-15. (canceled)
16. A needleless injector system for holding a fluid and delivering
a stream of fluid through an area, the system comprising: a plunger
extending about an axis and having opposed first and second ends
and an external surface, said plunger including at least one
concave rib extending about the axis, wherein said at least one
concave rib has an outer diameter extending away from and greater
than an outer diameter of the external surface; and an ampule
including an elongated hollow body having a first and second end,
the first end of the elongated hollow body including a nozzle, and
the second end of the hollow body including an aperture for
receiving the plunger, said aperture being in fluid communication
with the nozzle, wherein the outer diameter of said at least one
concave rib sealing engages the hollow body to expand and seal the
aperture in response to a deflection in the hollow body, wherein
deflections in the hollow body caused by a pressure force created
as the fluid is driven from the hollow body by the plunger is
sealed by the at least one concave rib.
17. The system of claim 16, wherein said plunger includes a second
rib, the second rib being disposed at the second end of the
plunger.
18. The system of claim 16, wherein said first end of said plunger
has a conical shape.
19. The system of claim 18, wherein said plunger includes a second
rib, the second rib being located at the second end of plunger.
20. The system of claim 16, wherein the ampule is made from a
polypropylene material.
21. A needleless injector system for holding a fluid and delivering
a stream of fluid through an area, the system comprising: a plunger
having opposed first and second ends and an external surface, said
plunger including at least one concave rib extending from the
external surface of the plunger, said at least one concave rib
having an outer diameter extending away from and greater than an
outer diameter of the external surface; and an ampule having an
elongated hollow body for receiving the fluid, the hollow body
having first and second opposed ends, the first end of the
elongated hollow body including a nozzle, the second end of the
hollow body being open to receive the plunger, wherein the outer
diameter of said at least one concave rib sealingly engages an
inner diameter of the hollow body to form a sealing fit therewith
to expand and seal the hollow body in response to deflections in
the hollow body caused by a pressure force created as the fluid is
driven from the hollow body by the plunger.
22. The system of claim 21, wherein said plunger includes a second
rib disposed at the second end of the plunger.
23. The system of claim 21, wherein said concave rib is
approximately conical in shape.
24. The system of claim 23, wherein said plunger includes a second
rib extending from said external surface, said second rib having a
generally conical shape and being located at the second end of the
plunger.
25. The system of claim 21, wherein the ampule is made of a
polypropylene material.
26. The system of claim 21, wherein the plunger is made of a
polypropylene material.
27. A method for preventing pressure losses in a needle-less
injector system while delivering a stream of fluid, the method
comprising the steps of: providing a plunger, the plunger having
opposed first and second ends and an external surface, said plunger
including at least one concave rib having an outer diameter that
extends away from and is greater than an outer diameter of the
external surface; providing an ampule, the ampule having an
elongated hollow body, the hollow body having a first end and a
second end, the first end of the elongated hollow body including a
nozzle, the second end of the hollow body being open to receive the
plunger, wherein the outer diameter of said at least one concave
rib sealingly engages an inner diameter of the hollow body to form
a sealing fit therewith; supplying the ampule with fluid and
placing the plunger into the hollow body so that the fluid is held
between the plunger and the nozzle; and compressing the fluid by
moving the plunger towards the nozzle, wherein the at least one
concave rib expands against the inner diameter of hollow body to
seal the hollow body in response to deflections in the hollow body
caused by a pressure force created as the fluid is driven from the
hollow body by the plunger.
28. The method of claim 27, further comprising the step of forming
the plunger form a polypropylene material.
29. The method of claim 27, further comprising the step of forming
the ampule from a polypropylene material.
Description
RELATED APPLICATION
[0001] This is a continuation of U.S. patent application Ser. No.
10/158,853, entitled "Needleless Injector and Ampule System," filed
on May 30, 2002. The present application also relates to U.S.
patent application Ser. No. 11/121,439, entitled "Needleless
Injector," filed May 3, 2005.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a system for the
subcutaneous delivery of medicaments, and more particularly to a
hand held actuator, and a plunger and ampule or vial used to
deliver a stream of medication.
[0004] 2. Description of Related Art
[0005] The need for a needle-less injection device that can be used
to deliver a fine, high-pressure stream of medication through the
skin has been recognized for some time. However, the problems
associated with creating this high-pressure stream, particularly
with a self-contained, hand-held device, has proven to be a greater
challenge than expected. The typical approach at creating these
streams has been to use a piston that is driven by a CO2 cartridge,
compressed air, or a spring. The piston is then used to drive the
medicament from a reservoir through a small nozzle that is used to
create the fine stream that is to penetrate the skin. The size and
energy of the stream allows the stream to penetrate the skin to a
depth where it can then be absorbed by the body.
[0006] One important problem is that in order to create such a
stream it is difficult to produce a nozzle that provides a tight,
uniform stream, and not a spray of the medicament.
[0007] Another important problem associated with the design of a
needle-less injection system involves the efficient delivery of the
dose of medicament held within the reservoir. In other words, it is
important that the system does not allow medicament to escape
between the piston and the reservoir or cylinder through which the
medicament is being delivered. The problem of loss of medicament is
typically caused by the escape of medicament under the pressure
required to adequately deliver the medicament through the
nozzle.
[0008] Still another important problem associated with needle-less
injection devices, and particularly with hand-held devices of this
type, is the provision of sufficient power to create and deliver a
stream with sufficient energy so that the stream can penetrate the
body to a depth where the medicament can be absorbed.
[0009] Yet another problem associated with needle-less devices is
maintenance of a required amount of pressure during the delivery of
the medicament from the reservoir, through the nozzle.
SUMMARY OF THE INVENTION
[0010] One object of the present invention is to provide a
needleless injection device that delivers a fine, high pressure
stream of medicament through a surface.
[0011] Another object of the present invention is to provide a
needleless injection system that delivers the medicament without
any loss of quantity thereof.
[0012] In accomplishing these and other objects of the present
invention, there is provided a needleless injection device
including an ampule. The ampule includes an elongated hollow body,
the elongated hollow body having a first end and a second end. The
first end of the hollow body includes a nozzle, and the second end
of the hollow body including an aperture for accepting a plunger.
The aperture extends from the second end towards the first end and
is in fluid communication with the nozzle. The generally
cylindrical plunger, includes a first end and a second end. The
plunger also includes a concave rib extending about the perimeter
of the plunger and extending towards the first end.
[0013] According to one example of the invention, the body of the
plunger is centered about an axis and the first end of the plunger
includes a generally conical end that is centered about the axis.
Additionally, the conical end will extend from the concave portion
of the concave rib. Still further, it is contemplated that the
plunger will include a second rib, the second rib being between the
concave rib and the second end of the plunger.
[0014] The plunger is received by the aperture in the ampule, with
the concave rib sealingly engaging the sidewalls of the aperture in
the body of the ampule. The second rib will also cooperate with the
sidewalls of the aperture of the ampule and may provide some
sealing function, but will primarily serve to stabilize or align
the plunger as it is forced through the ampule.
[0015] The ampule connects to an actuator that will provide the
power to push the plunger through the ampule and drive the
medicament from the ampule through the nozzle. In an illustrated
example of the actuator, the actuator includes a casing that holds
a spring that is used to drive a rod. The rod in-turn pushes
against the plunger, which then pushes the medicament through the
ampule.
[0016] The release of the spring in the actuator is accomplished by
providing a hammer that includes a forward end that is adapted for
cooperating with the rod and the trigger mechanism, and an aft end
that is adapted for cooperating with the spring. The trigger
mechanism is used to retain the spring in a loaded or compressed
position, and then release the spring to drive the plunger through
the ampule.
[0017] These and other objects, features, aspects and advantages of
the present invention will become more apparent from the following
detailed description of the preferred embodiment relative to the
accompanied drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a cross-sectional plan view of the system of the
present invention in a cocked position.
[0019] FIG. 2 is a cross-sectional view of the system of the
present invention in a fired position.
[0020] FIG. 3 is a partial cross-sectional view of the device of
the present invention illustrating the cooperation of the hammer,
push-rod, vial or ampule, and seal.
[0021] FIG. 4 is an enlarged cross-sectional view of the components
of FIG. 3.
[0022] FIG. 5 is an enlarged cross-sectional view of the seal or
plunger of the device of the present invention as it is driven
through the vial or ampule.
[0023] FIG. 6 is a cross-sectional view illustrating the
cooperation of the plunger and ampule of the present invention at
the end of the stroke or delivery cycle.
[0024] FIG. 7 is a side view of the hammer of the device of the
present invention mounted between the spring and the push-rod.
[0025] FIG. 8 is an end view of the hammer of FIG. 7.
[0026] FIG. 9 is a cross-sectional view taken along line 9-9 of
FIG. 7.
[0027] FIG. 10 is an end view of an embodiment of the plunger of
the device of the present invention.
[0028] FIG. 11 is a cross-sectional view of the plunger.
[0029] FIG. 12 is a perspective view of the plunger of the device
of the present invention.
[0030] FIG. 13 is a cross-sectional view of the vial or ampule of
the device of the present invention.
[0031] FIG. 14 is an end view of the vial or ampule of the device
of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0032] Referring to FIG. 1, a needle-less injection system 10 is
shown in a cocked position with the cover of the actuator removed
along with sections of the internal sleeve, so that the internal
components may be observed. It should be understood that it is
contemplated that the system of the present invention may be used
with a hand held actuator 12 or other actuator, for example, using
a pneumatic piston or combustion driven piston. Actuator 12
includes a hammer 14 that slides along a sleeve 16. The hammer 14
is powered by a spring 18 that is held within the sleeve 16. The
power or driving force provided by the spring 18 may be fixed by
creating a device that will allow the spring 18 to be compressed a
set distance or by providing a spring compression adjustment
mechanism 20, such as a threaded plug 22 that is mounted on an end
of the sleeve 16.
[0033] As shown in FIGS. 1 and 2, energy is stored in the spring 18
by compressing the spring 18 to the "cocked position" illustrated
in FIG. 1. This energy is then released to the hammer 14, which
drives a rod 24 that extends between the hammer 14 and a plunger
26. The plunger 26 fits into and seals an aperture 28 in an ampule
30. The ampule 30 is attached to the actuator 12 by way of a
bayonet connector 32 (FIG. 6), or a threaded or any other suitable
connector.
[0034] Referring to FIGS. 2-6, it will be understood that the
disclosed system will deliver medicament through the skin by
creating a very thin, high energy or velocity, jet of medicament 34
through the ampule 30. The jet of medicament 34 is produced by
driving the plunger 26 through the aperture 28 or open end 48 to
pressurize the fluid medicament 36 in the ampule 30, which pushes
the medicament 36 through a nozzle 38 located on second end 50 of
the ampule 30.
[0035] It should be appreciated that the ampule 30 will be made
from a readily moldable material, such as a pharmaceutical grade
polypropylene material that is suitable for injection molding or
any other polymer that is suitable for injection molding. An
important drawback to the use of polymers as the material for the
ampule 30 is that the mechanical properties of these materials
allow the materials to deflect under the pressures needed for
creating the jet of medicament 34 through the nozzle 38.
Additionally, fabrication of the ampule 30 from stiffer materials
results in a device that is too brittle or a device that cannot be
manufactured through the use of high production rate methods, such
as injection molding. Therefore, the machining of the ampules from
stainless steel would be a prohibitively expensive approach at
manufacturing the device. Furthermore, an opaque material will not
allow the user of the device to ascertain whether the plunger 26
has traveled through the desired length of the ampule 30, and
delivered the adequate dosage of medicament.
[0036] FIGS. 3-6 illustrate the entire travel of the plunger 26 as
driven by the spring 18 and hammer 14. Importantly, FIGS. 4 and 5
illustrate the deflection of the sidewalls of the vial or ampule
while the plunger or seal is driven towards the nozzle to force the
medicament from the ampule. The deflection 42 of the ampule 30 that
has been produced by the pressurization of the ampule 30 during
travel of the plunger 26 through the ampule 30 is shown by dashed
line. In known devices, this deflection 42 causes a loss of
pressure in the ampule 30, which results in an inadequate transfer
of energy to the jet of medicament 34. However, plunger 26 of the
present invention includes a concave rib 44 that is designed to
open towards the nozzle 30. The concave rib 44 should be made of a
flexible, yet strong material, such as polypropylene, rubber or
other polymer. As shown in FIG. 5, the plunger deflects to
compensate for the dimensional changes in the ampule.
[0037] In operation, as illustrated in FIGS. 3-6, the plunger 26 is
driven through the aperture 28 by the force of the spring 18
pushing against the hammer 14. As the plunger 26 is driven through
the elongated hollow body 46 of the ampule 30, the plunger 26
pushes the medicament 36 from the ampule 30 and through the nozzle
38. The elongated hollow body 46 of the ampule 30 include a first
end 40 and a second end 50. Thus, the plunger 26 is pushed through
the aperture 28, from the first end 40 towards the second end 50 of
the amplule 30. The pressure within the aperture 28 of the ampule
30 increase as the plunger 26 is pressed against the medicament 36,
causing the deflection 42 of the ampule 30. In order to maintain
the pressure, and hence the required energy transfer to produce the
jet of medicament 34, the concave rib 44 also expands under the
pressure, as indicated by the arrows 52 in FIG. 5. The expansion or
flaring out of the concave rib 44 takes up or seals any fluid
passages or bypasses that may be otherwise formed due to the
expansion of the amplule 30.
[0038] Thus, from the accompanying illustrations, it will be
understood that the plunger 26 extends about an axis 54 and may
also include a first end 56 (FIG. 11) that terminates in a
generally conical surface 58. Additionally, the plunger 26 includes
a second end 60 and a mid-portion 61, located between the first end
56 and the second end 60. Plunger 26 also includes an external
surface 62 that may be cylindrical or of any other suitable
cross-section. The concave rib 44 extends about the axis 54, and
expands towards the first end 56 of the plunger 26. In the
illustrated example, the concave rib 44 extends over the conical
surface 58 of the plunger and towards the first end 56 of the
plunger 26. Still further, in the illustrated example, the concave
rib 44 extends over a portion of the conical surface 58. The
conical surface 58 cooperates with the nozzle 38 to push any
remaining medicaments from ampule 30.
[0039] Referring to FIGS. 10-12, it will be understood that plunger
26 may also include a second rib 64. The second rib 64 is
positioned between the concave rib 44 and the second end 60 of the
plunger 26. The second rib 64 cooperates with the concave rib 44 to
stabilize the plunger 26 as it is driven through the ampule 30. The
design of the concave rib 44 has been illustrated as being
approximately conical in shape. This conical shape provides
flexibility that allows the second rib 64 to accommodate the shape
of the sidewalls 66 of the aperture 28. However, it is contemplated
that the shape or cross-section of the second rib 64 may be one of
many different shapes, and may not act as a seal, meaning that the
rib is not continuous about the exterior surface of the body of the
plunger 26.
[0040] FIGS. 13 and 14 provide greater detail of the ampule 30, and
illustrate that it is contemplated that the nozzle 38 can be
located within a raised annular portion 68, which in turn is
located within a recessed annular portion 70. The recessed annular
portion 70 cooperates with the raised annular portion to pull the
skin tight, and retain this tightness, around the nozzle opening
72, so that the nozzle opening 72 is at a distance from the skin
and the skin that is to be injected is pulled taut so as to avoid
energy losses in the jet of medicament as the jet of medicament
impacts the skin. In other words, by pulling the skin taut, one
minimizes energy losses due to deflection of the skin. Still
further, the bayonet connectors 32 are clearly visible from these
figures, together with radially positioned stiffeners 74.
[0041] Although the present invention has been described in
relation to particular embodiments thereof, many other variations
and other uses will become apparent to those skilled in the art. It
is preferred therefore, that the present invention be limited not
by the specific disclosure herein, but only by the appended
claims.
* * * * *